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Dr. Sin Hang Lee is at it again with his usual Gardasil fearmongering

Remember Dr. Sin Hang Lee?

If you don’t remember Lee, maybe you remember a while back, when the antivaccine group SaneVax touted findings that it claimed were devastating to Gardasil. Specifically, they claimed that there was vaccine-derived human papilloma virus DNA in Gardasi. Ring any bells yet? And it turns out that the guy who made this apparently horrific “discovery” was—you guessed it!—Dr. Sin Hang Lee. Back in 2011, Lee, apparently either funded by or working with SaneVax, “discovered” that there was DNA in his Gardasil. As I explained at the time, there was a lot less to this claim that meets the eye. Basically, Lee used a very sensitive nested PCR assay to amplify and detect what he claimed to be vaccine-derived sequences from the human HPV strains used to make the vaccine. Specifically, his nested system, as I explained at the time, can radically ramp up the sensitivity of the PCR assay. Of course, it can also radically increase the chances of amplifying a nonspecific strand of DNA.

Given that, it wasn’t too surprising that there might have been minuscule quantities of the recombinant plasmid used to make the protein antigens that go into the vaccine. At least, it wasn’t too surprising to me or anyone with a modicum of knowledge about how sensitive PCR is and how easy it is to get false positives. Even if Lee did everything right and actually did detect a bit of recombinant DNA from the HPV DNA used to make the vaccine. Does this matter? My answer, of course, was no, as was the answer of anyone who knew anything about vaccines and biologics. One factor to consider is how much DNA was present, which was almost certainly very, very little, given that it took nested PCR to detect it.

In fact, even if Dr. Lee’s analysis was completely correct correct and his new, allegedly more sensitive methodology had actually picked up previously undetected traces of HPV DNA from the plasmids used to make the HPV vaccine, it is, as I described before on multiple occasions, incredibly unlikely that such tiny amounts of DNA could cause problems because, as I explained, it’s incredibly difficult to get naked DNA into cells and making the proteins it normally makes, and, even if Dr. Lee were 100% correct about there being undetected HPV DNA in Gardasil, the quantities involved are many orders of magnitude less than what would be needed to have even a whiff of a wisp of a hope of the DNA getting into cells and making its protein. That’s even assuming it could pass the blood-brain barrier or that the DNA fragments were large enough to contain whole coding regions of genes with a proper promoter in front of them to drive their expression. I mean, it’s not as though whole plasmids are likely to have survived the vaccine manufacturing process, and that’s not counting the fact that Gardasil uses a yeast expression system while the other HPV vaccine Cervarix uses a baculovirus (insect) expression system, neither of which would be likely to drive significant expression in human cells.

So what we had was a fear mongering campaign derived from a nonexistent understanding of molecular biology. This campaign reached utterly ridiculous levels when the not-so-dynamic duo of HPV vaccine quackery, Sin Hang Lee and Christopher Shaw (who seems dedicated to the idea that somehow HPV DNA bound to the aluminum adjuvant in the vaccine is deadly) descended like ghouls on the corpses of two young women whose untimely deaths antivaccinationists have been trying to blame on Gardasil ever since they happened. This campaign reached a ridiculous extreme when they actually testified in an inquest in New Zealand into one of these two deaths, a young woman named Jasmine Renata, and tried, in essence, to claim that the poor woman’s body was riddled with HPV and that that HPV caused her death. It was an utterly despicable performance that Shaw, at least, followed up with an article in which he attempted to demonstrate that, in effect, Gardasil killed a young woman. It was not the least bit convincing.

And now Dr. Lee has taken his crack by publishing his paper related to the death of this same young woman in a paper published in an open-access journal I’ve never heard of entitled Detection of human papillomavirus L1 gene DNA fragments in postmortem blood and spleen after Gardasil® vaccination—A case report. Like Shaw’s paper, it’s a massive load of fetid dingo’s kidneys, and it won’t take that long to explain why.

First off, as I’ve always said before, you can tell what you’re in for in a paper by its introduction, and Lee’s introduction is a doozy. It’s full of anti-HPV tropes that would be more at home on the antivaccine propaganda blog Age of Autism (or SaneVax, for that matter). He does, however, inadvertently reveal what I’ve always suspected to be true about this case:

The parents of a formerly healthy New Zealand young woman who suffered a sudden unexpected death in sleep 6 months after Gardasil® vaccination requested testing for the presence of HPV L1 gene DNA in the post-mortem samples of their deceased daughter collected at the time of autopsy. Some of the consultants to the parents suggested that if residual HPV L1 gene DNA which is known to be present in the Gardasil® vaccine [8,9] were present in the postmortem samples, there might be a potential link between the residual HPV DNA and the un- explained death of their daughter. This paper reports the experience in developing a method for the detection and validation of minute quantities of HPV-16 L1 gene DNA in the postmortem blood and spleen obtained at autopsy. The data reported in this paper were extracted from a full report which was submitted to the Wellington coronial court at a public inquest held on August 8-9, 2012.

Who were these “consultants”? One wonders. Were they perhaps Sin Hang Lee and Christopher Shaw, aided and abetted by SaneVax? One wonders, one does. In any case, I wrote about the ridiculousness of letting Shaw and Lee testify at this inquest. One hopes that the committee listened politely and then completely ignored the pseudoscience as embodied in this paper.

So let’s take a look at what Lee did (or claims to have done). He took DNA isolated from these tissue samples and subjected him to his own new super-duper, super special, super sensitive nested PCR, looking for a 190 base pair sequence from the HPV L1 gene. As you might expect, given Lee’s background, there were…problems with his methodology. Rather than critiquing the exact primers he chose and how he went about doing his PCR, let’s step back and look at the experimental design from a bird’s eye view. Basically, he tested DNA from tissue samples from one young woman. There are no controls. How many people in the general population would test positive using Sin Hang Lee’s methodology? We don’t know because he hasn’t made an attempt to find negative controls, and without negative controls we don’t know that every tissue sample would test positive when subjected to his methodology. In fact, the only negative controls I saw mentioned anywhere were negative water controls. That’s perfectly fine to rule out nonspecific amplification that doesn’t depend on DNA (such as artifacts like primer-dimer, but it doesn’t tell you anything other than that.

Another issue is that troubles me is the way that Lee uses degenerate oligonucleotides. It’s worth going back to images I’ve sued before to illustrate nested PCR:

i-2b771ce908cdcfd17c0a348b0076e511-PCR.jpg

And here’s nested PCR:

i-c6eac1e243691b93238b7995321ea691-nested-pcr.gif

Nested PCR can be very, very sensitive, even more sensitive than “simple” PCR, depending upon the number of amplification cycles used in each PCR step. It’s that sensitivity that allows nested PCR to amplify very tiny amounts of target sequence. Now, Lee used a combination of degenerate primers and non-degenerate primers. A degenerate primer is a primer in which some of the positions in the sequence contain more than one base; i.e., there is a mixture of primers with different nucleotides at that place. The reason this is done, generally, is to amplify sequences for which we know there are variations in the sequence. Alternatively, it is done when trying to amplify sequences based on the protein sequence. Because of the degeneracy of the genetic code, most proteins can be coded for by more than one codon of three nucleotides. Usually, the variable base is the third base in the codon, but not always. To account for those nucleotides, degenerate primers are sometimes used as a way of putting a “wildcard” in the positions that can have more than one base in nature. However, such primers have a downside. The more “wild cards” a researcher puts in his primer sequences, the larger the number of potential sites to which those primers can bind. What one gains in sensitivity for potential coding sequences to be detected, one loses in specificity. It’s a tricky balancing act that is not as straightforward as those without much experience in PCR realize.

That’s why in general we avoid using degenerate primers except for this sort of purpose: Trying to isolate a sequence where we know that certain positions can have different bases. If the target sequence that a researcher is trying to amplify by PCR is known (and, make no mistake, the HPV-16 L1 gene sequence used to make HPV vaccine is known), it’s usually a bad idea to use degenerate oligonucleotides, because doing so will decrease specificity and greatly increase the chance of amplifying what I like to call crap. Basically, I can’t figure out why Lee would use the method he’s using. Arguing that there is variability in the natural HPV-16 L1 sequence and he wants to pick that up won’t wash. In fact, he is aiming to detect the vaccine strain sequence; so detecting any natural HPV that might have come from warts or other HPV infections would actually be counterproductive to what he’s trying to accomplish: To detect the vaccine HPV-16 L1 sequence postmortem in Jasmine Renata. It’s almost as though he’s intentionally trying to muddy his findings. Maybe more than almost.

In any case, the same-nested procedure used by Lee, as far as I can tell, involved using degenerate primers for the first round of PCR, and then selecting one set of specific primers that make up the degenerate primer mixture and then using them to repeat the amplification. The idea is to start out less specific and then get more specific by removing the degenerate primers in the second round of PCR. The problem is, of course, garbage in, garbage out. The other problem is, as I said before, we don’t have any negative controls from tissue samples from people who were not vaccinated with Gardasil. The reason this is important is inadvertently described in Lee’s discussion:

Since the human genomic samples contain numerous DNA fragments which are substan- tially complementary to the base sequences of the HPV PCR primers, co-amplification of non-target DNAs of the human genome invariably occurs in the same-nested PCR settings when PCR amplicons are re-amplified with the same primer(s).

Of course, Lee did sequence several of his products. The first sequence was clearly not a pure sequence, but was contaminated with additional sequences, which prevented identification and validation of the PCR product. A couple of the PCR products that Lee sequenced (Figures 6 and 7) were in fact genomic DNA, and it took a lot of fiddling with different primers and conditions for Lee to get fragments that sequenced as HPV 190 base fragments. This suggests to me findings that aren’t robust, which suggests to me that it’s more likely that he’s amplifying contamination than anything else, which, given the multiple rounds of PCR would be very easy to have happen if even a single prep of the plasmid containing HPV L1 were done in the same lab as the PCR of the DNA from tissue samples. That’s yet another reason why controls from tissue samples derived from people who were not vaccinated would be important.

Here’s another thing that would be important. Lee claims that vaccine-derived HPV L1 DNA is somehow hanging around in the body and that it, in essence, might have killed Jasmine Renata. It’s not as if the sequence of the plasmid that is used to make the protein antigen used to make the vaccine isn’t known. Lee only looks at HPV L1 sequence that is inserted in the plasmid. If fragments of the original plasmid used to make the vaccine were in fact still in the vaccine and somehow magically did continue to hang around in the body after vaccination at concentrations detectable by PCR, then it should more than just L1 there. There should be random fragments derived from the whole plasmid, not just the L1 insert. There should be readily identifiable plasmid and promoter sequences. In fact, the sequence I’d look for is a sequence containing overlapping the promoter used in the plasmid. That way, you’d detect HPV L1 sequence attached to the specific yeast promoter used in the manufacturing process connected to known plasmid sequence. It’s the obvious thing to do, because, if that sequence were found, it would be very hard to explain any other way than coming from the plasmid used to make the vaccine. It would even be hard to explain by plasmid contamination because the plasmid containing the HPV-16 virus that Lee bought from ATCC to use as his positive control for PCR reactions because that virus is in Bluescript, which is an E. coli plasmid.

Lee didn’t choose to do that. One wonders why. He even acknowledges that he knows about this issue:

The presence of HPV-16 L1 gene DNA fragments of a vaccine origin indicates possible co-existence of other companion microbial DNA, such as DNA fragments of the plasmid pGAL110 and yeast cells which are used in the vaccine production by the manufacturer [2]. A poten- tial consequence of these viral and microbial DNA frag-ments with their unmethylated CpG motifs in macro-phages [41-46] is to cause release of various cytokines, including tumor necrosis factor (TNF), a recognized myocardial depressant [47-51]. TNF-induced hypoten- sive shock is a documented observation among animals [52,53] and humans [54,55]. To answer the question whether the quantity of these persistent viral or microbial DNA fragments can stimulate the macrophages to release enough TNF to generate a significant pathophysiological impact following Gardasil® vaccination needs expanded research.

Uh, no. Lee should have done the research right in the first place if he wanted to convince anyone by actually looking for the sequences I described above, specifically an amplicon (the DNA target sequence to be amplified by PCR) that encompasses part of the L1 gene, the promoter region used, and pGAL110 sequence that is directly attached to the insert. He could also look for yeast genomic DNA sequences, as he himself suggested. The combination of finding HPV-16 L1 sequences from the plasmid used to make the HPV vaccine plus yeast genomic DNA would be very supportive of his hypothesis. Instead, Lee claims to have amplified L1 DNA fragments “of vaccine origin.” Yet he hasn’t proven that they are of vaccine origin. To do that, he would actually have to amplify some pGAL110 plasmid sequence as well as L1. Then at the end he concocts a handwaving explanation to justify why he had so much trouble amplifying L1 from Jasmine Renata’s tissues when he can amplify HPV L1 DNA from the blood of women infected with HPV-16 in other studies, in which the HPV DNA isn’t in the normal B conformation or is somehow stabilized by binding to aluminum adjuvants. It’s utter nonsense.

Much like everything I’ve seen published by Lee on this topic. No wonder SaneVax and Age of Autism love it so. It’s kind of sad, given that Lee clearly has some skill at PCR, that he chooses to use it for such a silly application in the service of antivaccine fear monger. As a physician with these mad PCR skillz, he really should know better. He should even know just how tiny the amount of HPV-16 L1 DNA there could possibly be in the vaccine, given that he could only detect it with a very sensitive nested PCR test and that that amount is so tiny that it is incredibly unlikely to hang around in the body for more than six months and be detectable in the tissues postmortem, much less cause harm.

Yet Lee chooses not to know.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

715 replies on “Dr. Sin Hang Lee is at it again with his usual Gardasil fearmongering”

Perhaps someone could clarify/simplify for me…

If HPV capsid L1 fragments are present in the vaccine – what of it? Isn’t that the whole point of the vaccination in the first place? As long as they are of a form unable to replicate I can’t see the problem.

If these fragments are still detectable in the host following vaccination, what is that meant to mean clinically (if they are truly there and not just false positives)? Is the hypothesis that these fragments somehow induce some sort of clinical disease? What disease? And by what mechanism could they cause death?

How do the antivaxers plausibly join the dots between points that are not even on the same page of paper, but in different dimensions?

I’ve been wondering:
He is looking for a specific fragment of the HPV. A sequence of 190 base pairs. So, is it possible that the same sequence of 190 base pairs is present in the human genome or any other bacterial or viral genome that may be present in the tissue?

Also, I don’t think you sued the pictures.

An unusual use of PCR to amplify how wrong you are about something.

Scary thing is he probably thinks he’s on some sort of crusade against vaccination when all it really does is prevent a really horrible disease

“…in a paper published in an open-access journal I’ve never heard of… ”

And again the dark side of Open Access publishing raises its ugly head. The author pays to have his/her research published which of course makes it tempting to a certain kind of company to except and publish every garbage just to get those fees.
I had a quick look at the journal this “paper” is published in and the publisher SCIRP is on the list of so-called “predatory publishers” that the librarian Jeffrey Beall compiled (http://scholarlyoa.com/). This means that this publisher is suspected to be the kind of company that doesn´t care for a proper peer review for the sake of the quick money. SCIRP even has its own Wikipedia entry which consists mainly of the negative headlines it made in the past.
While Open Access is in general a good idea to get your research a wide audience that does not need to pay the often incredibly high subscription fees for scientific journals, it is also open to abuse like this. Predatory publishers can make quick money without regard for scientific integrity and cranks can get their woo out in a “peer-reviewed scientific” journal without any scrutiny by real scientists – a marriage made in hell.

A degenerate primer is a primer in which some of the positions in the sequence contain more than one base; i.e., there is a mixture of primers with different nucleotides at that place.

Basically a wild-card search, then?

I still can’t fathom how the anti-vaccine crowd has convinced themselves that substances / inanimate stuff / dead viruses, etc. are supposed to massively replicate themselves in the human body….perhaps using some kind of “Quantum Reproduction?”

Given the levels of mercury or, in the is case, HPV, that is claimed to exist – where, supposedly, does it come from? Given no biological mechanism exists for replication?

Better yet, why is so sensitive a test necessary, when supposedly such large and horribly effecting quantities of these materials are supposedly found……amazing what people can convince themselves of, once they’ve entered the conspiracy bubble….

“Who were these “consultants”? One wonders.”

Indeed. I’d like to see him name them. Quoting accurately what they said would be a bonus. My guess originally was that these “consultants” were either members of SaneVax or local anti-vaccination proponents (for want of a better term) “assisting” the Renatas, but you’re right – they could be Lee himself and/or Shaw.

Another thought that bothers me is that if traces amounts of the HPV DNA from an ‘ordinary’ wart can make it’s way into the body, that would want to be ruled out too.

dingo199: That’s what Orac is getting at with his second and third paragraphs.

Pris: The idea is that the primers are specific enough to identify the target, but in practice this isn’t always simple. (See the figures Orac shows, esp. the second.)

hdb: Yup, nice way of putting. Varying/wildcarded in the particular positions that are degenerate.

Grant, I supose I have just posed the questions differently from Orac. But what I want to know is why do the antivaxers think that this matters, and how it could cause disease or death? Surely there must be some vaguely plausible concept they are floating here. OTOH they could just be as kooky as QuantumMAN.

dingo199,
As I understand it Lee and Shaw claim that the aluminum in the vaccine attaches to the HPV antibody and to residual DNA which then hitch a ride to the brain in white blood cells. Normally the blood brain barrier would stop WBCs from entering the brain, but a severe immune reaction can break the BBB down, letting then in. L & S claim that the vaccine causes such a reaction, allowing these white blood cells to deposit HPV antibodies and/or DNA in the brain where they cause an inflammatory reaction and sometimes death. A number of steps in this scenario seem extremely implausible to me, but not in the same league of kookiness as QuantumMAN..

To borrow from a recent Twitter meme:

We would’ve used proper PCR, but it would have invalidated this paper #overlyhonestmethods

I can only conclude that given Sin Hang Lee’s expertise that he is intentionally gaming his assay to produce a desired result. You don’t use degenerate primers when the sequence target is known. Also, given the small amplicon size, why not quantitative real-time PCR? Even if there is vaccine-derived HPV genomic fragments there, so what? As Orac stated, it’s no easy task for recombination or expression to occur and highly implausible that there is any appreciable immune response. It sure plays to an ignorant audience though.

If having minute fragments of HPV DNA in your system predisposed to sudden death, we would have long since noted an epidemic of women dropping dead all around us from “natural” HPV infections.
I have to admit I stopped reading after the part about Lee not using negative controls. His “research” became a load of crap right then and there.

On the subject of vaccination, there was an interesting op-ed in USA Today 1/8 by a physician, protesting the firing of health care workers who don’t comply with regulations mandating influenza vaccination.* It struck me as an unsavory form of special pleading (if physicians are going to support mandatory immunization for kids (as they should), they shouldn’t try to duck out of required shots for themselves on the basis that flu shots aren’t all that effective or shown to prevent X amount of deaths in health care settings). Might be a good subject for an Orac takedown…

h_tp://www.usatoday.com/story/opinion/2013/01/07/flu-shots-mandatory-health-workers/1816361/

In related news:

Yesterday, Gary Null’s anti- flu vaccine fearmongering was aided and abetted by Dr Tom Jefferson ( Cochrane Database Collaboration, Rome) who appeared ( Gary Null Show/ Progressive Radio Network/ about 44 minutes in- 58 minutes):

when asked about the safety and efficacy of the flu vaccine for pregnant women, Jefferson made statements about pregnancy not being an illness and pregnant women being therefore healthy adults( studies are about healthy adults though not pregnant) but noted how many people needed to vaccinated in order to prevent one case of “symptoms” ( 33-99) and said that “harm is under-studied”. He was taught in med school that with pregnancy ” the less you do the better”. Because of the foetus, he advises being “cautious”.There are few studies he adds.
Encouraging, n’est-ce pas?

He advises more studies in general ( Big News!)

In 2009, his review of flu vaccines found “only 5% to be reliable”. Of course, “industry-funded research” is more likely to be” published in prestigious journals”.

The ” good science is under-studied”, there is “little good research” and there are “tons of bad studies”.

I’m sure that his quotes will make the rounds at anti-vax sites like a supplement salesperson at a natural health convention. In other words- they fit right in and mingle well.

As an added bonus, Null hosts the two nurses who lost their jobs because of their flu vaccine refusal. ( after Jefferson).

Null has a new anti flu vax article up ( @ PRN) and presents one whose authors include Jefferson ( DIMicheli et al).

These are malevolent evil vaccine DNA fragments, they kill you. Not like the beneficial natural HPV DNA that gives you livelong immunity from itself.

I deliberately included details from Jefferson because – although I’m not sure if it was due to his own choice or Null’s questions- the material focused upon risks, cautions and reports of inefficacy, bias and bad research without one mention of benefit. He could have slipped a few words in but didn’t.

Null summed up ( after TJ left) about how figures cited about influenza deaths are misleading ( pneumonia not flu).

Alt media continually uses this method: emphasising negative aspects and neglecting to discuss positives. Isn’t science supposed to explore the entire situation as it exists in the real world?

@Denise – it is cause & effect….a lot of people wouldn’t get pneumonia & die, if they didn’t get the flu first and have it progress…..idiots.

Yesterday, Gary Null’s anti- flu vaccine fearmongering was aided and abetted by Dr Tom Jefferson ( Cochrane Database Collaboration, Rome) who appeared

Now why did he have to do that? Dr. Jefferson is an asset to evidence-based medicine; he makes valid criticisms of industry research. But why belittle yourself and trash your credibility by associating yourself with NVIC and now (even worse) Gary Null?

Yesterday, Gary Null’s anti- flu vaccine fearmongering was aided and abetted by Dr Tom Jefferson ( Cochrane Database Collaboration, Rome) who appeared ( Gary Null Show/ Progressive Radio Network/ about 44 minutes in- 58 minutes):

Got any links?

Missouri nurse fired for refusing to wear a surgical mask after declining flu vaccination:

“Brock was let go when she told her superiors that she would not put on a surgical mask. It’s the kind the hospital requires for employees — like Brock — who are not vaccinated against the flu.”

“A board-certified holistic nurse, Brock said, “I have spiritual and religious reasons to not have those toxins in my body.”

“Brock is speaking out because she believes the hospital’s new requirement to wear the mask amounts to a scarlet letter; CoxHealth says it is simply putting the patient first.”

http://www.news-leader.com/article/20130108/NEWS01/301080030/coxhealth-nurse-fired-flu-vaccine-surgical-mask

What exactly are the “religious” and “holistic” justifications for not wearing a surgical mask? And Brock admits her “religious” exemption from flu vaccination was essentially bogus:

“In early September, Brock sought and was granted a religious exemption, although she admits she’s more “spiritual” than “religious.”

I would rather she be suspended and required to take CME on infectious disease and what constitutes a “toxin” rather than be fired – but the hospital has to protect its patients.

Note: one hospital I work at requires all staff – doctors and nurses included – to wear masks if they don’t get the flu vaccine.

@DB – so, she doesn’t want the vaccine & the refuses the alternative too? That just doesn’t make any sense and seems like she was asking to get fired……

@ Science Mom:

You know, I listened to the tape twice and for the life of me, I can’t hear anything that tells me that there was a massive edit. But you never know. Although I am now also starting to get suspicious about Jefferson- he seems to get quoted often by woos.

I would think that if I were ever interviewed by a person who was fixated against SBM and had spurious credentials – first of all I probably wouldn’t grace their outlet with my presence- if I did show up, I would be very careful of how I spoke. Let’s say it was about psychiatric meds: I would preface or conclude any remark I made about side effects or risks with a mention of how these meds assist many people. He doesn’t seem to notice Null’s leading questions and address his bias which I think is apparent.

Nulls says that there are “flaws in the data” and Jefferson agrees mentioning his own review which found only 5% of vaccine studies reliable. Now that’s leaving a wanker lots of room to wank in.

I wonder if he’s following the path of Montagnier?

@DB

These nurses really do sound like whiny little children. And like you say, so what if she has spiritual/religious objections to flu shots? That has nothing to do with wearing a droplet barrier to protect her patients.

You know, I listened to the tape twice and for the life of me, I can’t hear anything that tells me that there was a massive edit. But you never know. Although I am now also starting to get suspicious about Jefferson- he seems to get quoted often by woos.

Anyone who criticises the evil Pharma is going to get quoted by the woos. Ben Goldacre was often cited by the anti-vaxxers until he thrashed their sacred cow St. Andy. Heck even I have been held up as an authority by them when I have proffered a criticism of a vaccine recommendation or industry practice. But you don’t pander to them as Dr. Jefferson is doing; it’s a really bad move for his credibility and I’m having a hard time believing he is that naive. The Cochrane Collaboration is very important and he shouldn’t be risking putting a stain on it particularly when there are so many legitimate outlets for him to use.

Missouri nurse fired for refusing to wear a surgical mask after declining flu vaccination:

“Brock was let go when she told her superiors that she would not put on a surgical mask. It’s the kind the hospital requires for employees — like Brock — who are not vaccinated against the flu.”

“A board-certified holistic nurse, Brock said, “I have spiritual and religious reasons to not have those toxins in my body.”

“Brock is speaking out because she believes the hospital’s new requirement to wear the mask amounts to a scarlet letter; CoxHealth says it is simply putting the patient first.”

http://www.news-leader.com/article/20130108/NEWS01/301080030/coxhealth-nurse-fired-flu-vaccine-surgical-mask

What exactly are the “religious” and “holistic” justifications for not wearing a surgical mask? And Brock admits her “religious” exemption from flu vaccination was essentially bogus:

“In early September, Brock sought and was granted a religious exemption, although she admits she’s more “spiritual” than “religious.”

Can the hospital state the patients have spiritual reasons not to get in touch with unvaccinated personal? If health-reasons aren’t worth more, than spiritual or religious reasons?

I guess Brock has done me a favour in making me learn what a “scarlet letter” is. Perhaps she’s done public health another one by getting herself fired.

And Brock admits her “religious” exemption from flu vaccination was essentially bogus

The use of the word “toxins” is all that was required. One might think that such people could at least do a little homework.

The flu’s a respiratory condition, right? Pneumonia as a result of a respiratory virus seems logical to me.

The idea is that the primers are specific enough to identify the target, but in practice this isn’t always simple.

Basically a wild-card search, then?

To be fair, the method and primers that Lee uses is indeed appropriate for the detection of HPV L1. I put all his primers, degenerate and otherwise, into BLAST-PCR and they indeed return only HPV L1, no sequences of human origin or any other non-HPV organism. So it’s not a valid criticism to say that his use of ‘degenerative’ primers is inappropriate, or somehow invalidates the paper.

The real problem here is that he’s not showing what he claims he’s showing. That is, it’s not sufficient to merely identify the presence of HPV L1, he must also show the origin of such sequences, as Orac points out. That, and the fact that he simply has no proper controls.

But let’s not get focused on the method, it is indeed an appropriate method, it’s just pointed at the wrong target.

(Though, like Science Mom, I would have much preferred an RT-qPCR approach)

More total awesomeness from Advances in Bioscience and Biotechnology: When they retracted (disappeared, actually) “Molecular Genetic Program (Genome) Contrasted against Non-molecular Invisible Biosoftware in the Light of the Quran and the Bible,” they repaginated.

To be fair, the method and primers that Lee uses is indeed appropriate for the detection of HPV L1. I put all his primers, degenerate and otherwise, into BLAST-PCR and they indeed return only HPV L1, no sequences of human origin or any other non-HPV organism. So it’s not a valid criticism to say that his use of ‘degenerative’ primers is inappropriate, or somehow invalidates the paper.
Point taken. 😀

Science Mom,

You wrote: “I can only conclude that given Sin Hang Lee’s expertise that he is intentionally gaming his assay to produce a desired result.”

I haven’t read the paper but it’s possible the degeneracy is to cover known variation in HPV strains.

There’s two aspects here: the method itself and the application of the method. Lee may well have technical expertise in the chemistry of PCR, etc., but his biology in applying the method and interpreting the results is awful.

Presume for a moment that the method is just fine. He cannot conclude or even imply what he finds is from a vaccine as he has no means to do that. Nor can he imply that finding this DNA would indicate a means for a vaccine to cause the death of the patient. That would be pure speculation (and poor speculation at that given the biology involved) as even were sound evidence of vaccine-derived DNA present, you’d still have to establish that the DNA would do anything harmful or anything much at all.

(Having written this, I see AdamG has expressed similar thoughts.)

(My own personal opinion) Dr. Tom Jefferson’s television interviews during the Swine Flu pandemic lead me to believe that he is biased toward public health and toward influenza vaccine manufacturers as well, based on some sort of conspiracy theories.

here…

and here on Swedish TV…

(Though, like Science Mom, I would have much preferred an RT-qPCR approach)

Actually, I don’t think that would have been the right approach, given that he’s looking for DNA fragments, not evidence that the HPV-16 L1 RNA is being expressed, and it’s also very likely that RNA would be very degraded in a postmortem sample. Just sayin’.

OT but related… There’s a study circulating in the anti-vax realm about mumps vaccinations failing significantly in a specific Jewish population. Anybody dissected and debunked that one yet?

“A board-certified holistic nurse, Brock said, “I have spiritual and religious reasons to not have those toxins in my body.”

Check out her Web site.

OT but related… There’s a study circulating in the anti-vax realm about mumps vaccinations failing significantly in a specific Jewish population. Anybody dissected and debunked that one yet?

I think the authors of that one explained the unusual occurrence of spread on extremely intense transmission opportunities (though why there was still reduced protection offered against infection is unclear to me).
They said vaccination was successful in that it confined the outbreaks to the small epicenters of jewish schools and protected the rest of the community.

given that he’s looking for DNA fragments, not evidence that the HPV-16 L1 RNA is being expressed

Whoops! I should have clarified that I was referring to Real Time qPCR (for DNA), not Reverse Transcibed qPCR (for RNA) as Orac took it to mean. The nomenclature on these two is often interchanged and even in the literature it’s rather confusing…RT-qPCR refers to the DNA assay in my lab but I see this is not universal.

Yup, Brock endorses rank cancer quackery:

How dare we be so bold as to discuss the truth about cancer? How can we say that it is another symptom and it is actually a compensation at the cell level to preserve one’s life? That by changing the environment and the underlying cause, cancer cells will revert to normal function? We will tackle this sacred cow and number one profitable disease of the medical system. Why have other countries discontinued radiation and chemotherapy? Maybe because conventional U.S. cancer treatment has less than 3% success rate? Are there alternatives with higher success rates? Remember we don’t treat cancer and we don’t have to because we build health.

One might wonder whether her employers were fully apprised of this side venture or that she advocates nurses’ pushing “spirituality,” defined as “a force that provides the ability to transcend the natural laws and orders of this life, allowing access to a mysterious or transcendent dimension.”

(Watch for the lame excuse, Dingo199)

I was busy posting on the Ho-Po about the Goshen Hospital nurses who were fired for not complying with their employer’s mandated flu vaccine, and an HPV vaccine thread. (I also linked to today’s RI article on Dr. Lee.)

Thanks for the correction. 🙂

dedicated lurker: Yep, exactly so. I didn’t manage to get an influenza vaccine this year despite asking for it twice, and I’m now getting over pneumonia secondary to influenza. It was a real trip.

All of the personnel at my doctor’s office wear little slips showing they’ve been vaccinated for influenza (100% uptake rate) and they make patients showing respiratory symptoms mask up when they come in.

I have about zero sympathy for these whiny jerks and their “toxin” BS. What about the “toxins” the pathogen was putting into my (still-painful) lung, dammit? I would bloody hope that any alleged healthcare “professional” who pulled a routine like that would be fired. All that education, and still pulling that crap; there’s no hope for them.

She’s not a nurse. She does not represent anything that a real nurse should. She is endangering people, especially those with respiratory conditions. If she won’t even wear a mask, she should be fired. Does she wash her hands?

She’s not a nurse. She does not represent anything that a real nurse should.

Well, she has a license. On the other hand, her “non-thesis” (PDF) opines that “the emphasis on a medical approach to patient care in nursing education and practice is leading the nursing profession dangerously close to the medical model of cure and away from its holistic origins.”

Maybe it’s just me, but if I’m in a hospital, I’m kind of going to be expecting application of this “model.”

Well, she has a license.

That was a figure of speech, but I would guess you understood that. As I sit here listening to my bronchial passages gurgling from whatever flu/cold epidemic is going around, I offer to breathe on her without a mask.

That Carla Brock is a real lulu. I see from the website that she and her colleagues have set up a nifty Internet practice ($60 an hour for several initial and any followup “consultations”). Better yet, before they’ll accept you as a patient, you have to become a member of the “American Healthiatry Association” by signing a document that amounts to an elaborate Quack Miranda Warning:

“I, ___________________________________ hereby grant the Power of Attorney to Healthiatry Consultant: __________________________to act on my behalf as a health consultant, and to perform, or have performed, whatever testing is needed to best ascertain the status of my health from the Healthiatry perspective, and to prepare a suggested health building program for the improvement of my health, and all such services incidental thereto, which I have a legal and lawful right to perform for myself, and I agree to hold him/her blameless for any and all such acts.
I recognize that the health and nutritional information given me may be unorthodox and revolutionary, and may not be currently utilized or approved by the medical profession, the Food and Drug Administration, nor any “recognized health authority”. I also recognize that such information and suggestions may even be deemed unwise, unsound, or unsafe by conventional medical authorities.
Having been informed of the controversial nature of a natural and nutritional approach to building health, I have, of my own free will chosen to consider this alternative method. I have read the principles, methods, philosophy and Scope of Practice of Healthiatry and, being of sound mind, I give my consent for a specific health building program to be prepared for me according to those principles.
I further state that I am aware that the services of a Healthiatry Consultant and the suggested nutritional and health programs are not for the diagnosis, prevention, treatment, alleviation, mitigation, care or cure of any disease of any kind or nature whatsoever. I agree that I am responsible for obtaining qualified medical assistance for any “disease” or “pathological condition” if I so desire.”

My holistic quack-o-meter is sounding off loudly.

@DB – holey-crap, they let anybody put these things together……let’s see “revolutionary & unorthodox”….wow, quack meter is off the scale!

I haven’t seen reading this high since the Mass Sponge Migration of 1926….

I have, of my own free will chosen to consider this alternative method. I have read the principles, methods, philosophy and Scope of Practice of Healthiatry

The scope-of-practice statement is pretty good of itself: “The Healthiatrist uses only AHA approved tests, nutritional and supplement regimens and the use of any testing procedure or recommendations outside this Scope of Practice is grounds for removal of the right to practice under the name of Healthiatry.” Pretend medicine always combines well with pretend lawyering.

Oh, and she may want your stool.

“the emphasis on a medical approach to patient care in nursing education and practice is leading the nursing profession dangerously close to the medical model of cure and away from its holistic origins.”

SO a lady who is actively opposed to “a medical approach to patient care” is fighting for her right to take her Typhoid Mary act into a hospital. What?

JustNuts:

There’s a study circulating in the anti-vax realm about mumps vaccinations failing significantly in a specific Jewish population. Anybody dissected and debunked that one yet?

I saw that and commented about it here. I also ran across it on my tablet news app as a NaturalNews story, word for word:
http://www.naturalnews.com/038554_mumps_outbreaks_vaccinations_children.html

They both claim that 97% percent of the mumps cases had been vaccinated, when the NEJM paper actually said 97% of the cases were that particular Jewish community. Big difference.

I just checked the original article I found, it is gone. It looks like the chiropractor was not only lying, but plagiarizing.

Brock also has a sorta-blog.

Want more energy? This Building Block – UTILIZATION will present not only where energy comes from, but also how we may help and/or hinder good energy production.
Clue: Energy = Heat

From the sorta-blog:
” we have quite a following!! And we believe that is due to the integrity of our message and our own pure intention”

Either she’s better at tongue-in-cheek commentary than I am ( which is not at all likely)
or the self-evaluation part of her executive functioning can use a little more energy or healing.

I went to the fired holistic nurse’s website. I didn’t get as far as that crazy ultra-quack-miranda thing; I couldn’t get past the word “New-trition” at the top.

New-trition?

Seriously?

Oh, I thought I should issue a warning to the un-initiated:

earlier today I guided readers over to the Progressive Radio Network for the Jefferson interview by Null; if you should go to their home page, you will be greeted by links to articles and shows involving anti-vaccinationism (“The Great Flu Vaccine Hoax: Lie’s (sic) About Its Efficacy and Safety”), hiv/aids denialism ( Christain Fiala), anti-psychiatry ( Peter Breggin), a forecast by “trends analyst”, Gerald Celente- who is profoundly anti-reality- AND video testimonials..I think that that has to be some kind of a record.

I would exercise extreme caution if I were not already de-sensitivised to the level of blather intrinsic in this content.
You never know when your head might explode. And who would want that?

S, why are you sick? Didn’t you get your flu shot? Or did you and it just didn’t work?

Dr. Sin’s (or is it Dr.Lee’s, I’m never sure) results remind me a bit of people who think alternating the “zoom” and “sharpen” buttons in Photoshop for a couple dozen cycles actually brings out tiny details. There’s one guy who has found invisible crystal palaces in the backgrounds of the Apollo moon pictures – really he’s just ramped up the black-sky scanner and image artifacts – and of course we all remember the “Face on Mars” folk.

Unrelated, but as an amateur (in the old sense) of Latin and Greek, “Healthiatry” annoys me greatly.

or is it Dr.Lee’s, I’m never sure

“Lee.” It’s second only to “Kim” as a Korean family name.

dedicated lurker: Yes, the flu is a respiratory virus. Flu+ pnumonia together are quite effective killers- a lot of victims of the 1918 pandemic succumbed to the pnumonia that followed the flu.

DW: when asked about the safety and efficacy of the flu vaccine for pregnant women, Jefferson made statements about pregnancy not being an illness and pregnant women being therefore healthy adults( studies are about healthy adults though not pregnant) but noted how many people needed to vaccinated in order to prevent one case of “symptoms” ( 33-99) and said that “harm is under-studied”.

I hate when people do this. Even I know that a healthy pregnant woman has a depressed immune system. As I understand it, the immune system is dialed back to prevent white blood cells from attacking the fetus, but as a result, the white blood cells are prevented from attacking anything else-like the flu. Please correct me if I’m wrong.

Loose question because I’m trying not to get distracted – did Lee sequence what he PCR’d up, or is he asserting it’s a match based on the PCR yielding something (of the right size) – ?

@ Politialguineapig:

I know but you see, he’s the doctor – and we’re not. So obviously he knows what he’s talking about which would be especially appreciated as he is addressing a public health expert, the interviewer, about the inefficacy and risk of vaccines.

Please don’t look at me like that.

-As I said previously : tongue-in-cheek commentary, I has mad skillz.

@Jen, I got my flu shot. Two weeks later, around December 26 I started feeling sick. It has progressed into a really bad respiratory thing. I wouldn’t call it the flu, since I don’t have a fever or major GI problems. I have a history of pneumonia though.

@ Grant:

did Lee sequence what he PCR’d up, or is he asserting it’s a match based on the PCR yielding something (of the right size) – ?

AdamG upthread:

I put all his primers, degenerate and otherwise, into BLAST-PCR and they indeed return only HPV L1, no sequences of human origin or any other non-HPV organism.

But not the amplicon sequence itself. The link to the Lee paper doesn’t seem to be working so I can’t see if the GenBank # is reported.

Hold on, just got link working and will take a look but the abstract doesn’t look so good.

S – Jen’s a troll from under the AoA bridge. She’s particularly fond of raving about things that “cause” autism. My favourite was her “Paracetamol/acetaminophen causes ASDs” theory.

Jen – here’s a mindblowing fact to consider: even if every vaccine on earth was 100% effective (a claim never made) there will always be people who cannot be vaccinated. That’s why herd immunity is important.

Also, influenza mutates so rapidly that until we have the ability to whip up vaccinations (against a particular strain) on the spot, the NNT will always be fairly high, when compared to. other VPDs.

I’m sure someone as intelligent as yourself realises that, without tests, it’s impossible to know whether someone complaining of ‘flu’ has actual influenza, a flu-like illness, or a cold. Therefore infection rates based on self-reporting do not give a true picture.

elburto:

S – Jen’s a troll from under the AoA bridge. She’s particularly fond of raving about things that “cause” autism. My favourite was her “Paracetamol/acetaminophen causes ASDs” theory.

Actually those are two different persons calling themselves “Jen.” The one who does not like “Paracetamol/acetaminophen” lives in Texas, and now posts with “Jen, TX ” or “Jen from Texas.” She is quite unhappy with the treatment received at “Thougthful House”, and often posts jabs at the Johnson family and their company. Other than that, she has opened her mind to science.

On the other hand, the Jen you responded to lives in Canada. She does not have an open mind, and for a while would post several sock puppets on one thread. She has stopped this practice because the only thing she pried open her skull to take in was Orac’s warning that she would be banned if she did it again.

They are two separate people.

There is no GenBank deposit by Lee for this and in section 2.4 of the paper:

Alignment analysis of a 45 – 60 base sequence in the hypervariable region of the L1 gene excised from the computer-generated
base-calling electropherogram was performed against various standard HPV genotype sequences stored in the GenBank, using the on-line BLAST (Basic Local Alignment Search Tool) system to validate the specific HPV genotyping.

So we’re down to a 45-60 bp fragment and no GenBank accession number. Will someone else take a look at figures 4 and 5 electropherograms and see if those align with the sequence he says is a 100% match?

Jefferson made statements about pregnancy not being an illness and pregnant women being therefore healthy adults

Old age is not an illness. Nonagenarians are therefore healthy adults.
Infancy is not an illness. Newborn infants are therefore healthy adults.
Hmmm.

Ken wrote:

Unrelated, but as an amateur (in the old sense) of Latin and Greek, “Healthiatry” annoys me greatly.

You’re not alone.

It occurs to me that a degree of linguistic conservatism may be adaptive in scaring you away from quacks, who collectively seem just as addicted to jarring neologism as to bad logic.

Healthiatry is pretty bad too. Why is it that so many cranks feel the need to invent new words all the time, and do it so badly? New-trition? Healthiatry? And here, I thought “dis-ease” was dumb enough. (Ooh, we’ll be all mavericky and stuff because we put a HYPHEN in it so people know how clever we are at noticing a word’s etymology!) New-trition is stupid. (“She turned me into a newt!” “A newt?” “I got better.”) But I agree; healthiatry is the linguistic equivalent of fingernails on chalkboard.

Recently the sites I survey appear to be discouraging use of the flu vaccine- especially PRN and Natural News.

Interestingly enough, it is winter in the northern hemisphere, the season when flu is more likely to occur there and occasionally lead to more serious conditions.

Two articles from UPI.com:

Flu increasing in Europe, more 2009 H1N1-

the European Centre for Disease Prevention and Control reports widespread flu in Belgium, Denmark, France, Norway and England; regional activity in Italy and the Netherlands etc.

CDC: Seasonal flu rising sharply-

NYC and 29 states experience high rates of influenza-like illness etc.

Alt media: safeguarding public health as usual, exhibiting their storied compassion for their fellow and sister humans’ suffering unlike those SBM creatures.

( cavalierness personified- see my comments on Tom Jefferson, above)

Went to the sacbee blog entry, lilady.

When someone believes it’s meaningful to express the amount of mercury present in a molecule of thimerosal in terms of “per cent by volume” they’re clearly too ignorant of the most basic principles of chemistry to participate in a discussion regarding its safety.

I’m imagining the following scenario:
you live in a large city in one of the countries mentioned- let’s say NY or London- you work in an office with perhaps, 70 other people and ride on the train with hundreds. Maybe you shop in a grocery that enjoys brisk business all day long and then visit a bank during your lunch hour . After work, you might eat in a curry restaurant with friends and then have a drink. You pay for this with money or cards.

If you were to follow the instructions of woo-meisters, you might believe that as long as you get enough vitamin D ( or C), you’ll be fine. A pint of green juices and learning how to de-stress might help too. Perhaps the turmeric in the curry might protect you. As will ginger and cayenne.

Dream on, oh un-perturbed dreamer.
Yes, you’ll be fine. There’s no need for vaccines ever because natural, Gaia-blest healthy immunity wards off viruses and bacteria. And clean-living, I forgot that.

Don’t forget proper emotional intent, denice. Not only dod you have to get the vitamin D, green juices, get reiki to balance your chakras, accunpuncture to unblock your meridians, and meditate to relieve toxic stress but you have to do it really, really sincerely..

Otherwise when you do become sick even after following all their recommendations they can’t turn around and blame you for the failure–you just didn’t want good health enough.

@ JGC:

I think that ‘proper emotional intent’ is part of ‘clean living’:
serenity, gratefulness, mindfulness, promoting peacefulness, spirituality, sustainability and naturalness, naturally. Without anger and greed.

Sounds about right.

@ lilady:

I really have to hand it to you: I just survey and explore the swamps, creating maps of their muckiness, you have it out with the swamp folk.

So despite having failed to prove his argument to a judge where the standard for proof is “50% and a feather”, Victor’s going argue with people who actually understand the science that he’s right? Woner how well that will work for him …

@Denice Walter

And any failure is simply because you didn’t believe enough. But we’re not blaming you, you faithless heathen. No, deary, it’s not your fault you just lack the mental and spiritual fortitude to be healthy.

@ Todd W.:

You are correct: they are truly peaceful, kind, accepting human beings.. even when they’re ranting, raving and demanding someone’s head.

ScienceMom,
The sequences from Figures 4 and 5 are overlapping ones in the L1 gene. The entire sequence is a 99% match to the isolate (HPV16 16W12E) he cites. It’s a 100% match to other HPV16 isolates.

I am a mother of a Gardasil vaccine injured child. Blistering rash starting apx 3 weeks after the first vaccine (provider said no connected to Gardasil)
She ended up with a shingles dx and a recommendation: “don’t look on the internet this has nothing to do with Garadsil”.
3 weeks after the second shot she developed hives. The hives never went away. Her immunologist said there was no connection to Gardasil and thought she should get the third shot so that she could be protected from Cancer. She got the third and final shot on July 11, 2012.
All you jerks on here who are so crass in your disgust about “anti- vax” moms have no idea what we are going through in 2013. NO IDEA!
After her third shot of Gardasil her hives became a crisis! She had dermatographism, angioedema, severe pain (a 7 most of the time on a 0-10 scle) in her fingers around her joints, in her toes and in her knees. Her joints hurt so bad she had a hard time to walk. She had deep red wheals on her hands and feet. About 5 – 6 weeks after the last shot…for a few days she would become pale, have waves of nausea and need to sit down. She vomited over a few days and was extremely tired. She also had a severe headache. Since EVERY doctor involved refuse to even talk about Gardasil being the cause it drove me on line to find out what in the world is going on here.

Thousands of other girls also have autoimmune and autoimmune initiated neurological disease developing within a month after Gardasil. Most do not show symptoms right away and it seems a lot of them are showing symptoms weeks out from the shot….2-4 weeks usually. After the symptoms start they wax and wane, some days are better than others, you might have a stretch where the symptoms seem under control and you think they might go away and then they come back again, seems to be a week or 2 of mild to moderate symptoms followed by a few days to a week where her symptoms are so bad she looks like something out of a horror movie with scratch marks puffed up all over her face (dermatographism) hives and wheals so she is limping around. All the kids and teachers in her class have seen it and I have spoken with the school board, superintendent and district nurse. These people have her entire medical record and I have given them all the information from Diane Harper as to the efficacy problems and the safety issues as she has stated Gardasil does cause autoimmune disease, it does cause death and it did cause both of those in clinical trials, and it was placed on the market without being fully tested. NONE of that is told to the parent (ME) before their child is vaccinated.) Yes I have a lawyer and yes I have it in writing from an expert that Gardasil is the cause of my daughter’s urticaria and arthralgias.
This is OBVIOUSLY due to Gardasil. You “Pro – vaxers” will reply with some kind of bull crap statement about how it could be any number of things. Sorry, nothing was different NOTHING except Gardasil. So easy for physicians to say….NOPE not connected sorry we just don’t have any idea why your daughter has developed urticaria, arthralgais, dermatographism, angioedema, headaches, nausea, fatigue, muscle pain, (she had tingling underneath her toe nails for a few days…that was fleeting and went away but as a nurse I know there was a neurological component going on there, the nausea, headache, dizzy feeling, tingling, all went away slowly over a few weeks and I am so very thankful for that. She is just left with urticaria (including hives and wheals), dermataographism, angioedema, arthralgais, It was all triggered by Gardasil and anyone who says it wasn’t is doing so to protect their position.
I am one of the anti – vax moms you are talking about and I have to tell you…. I am very curious about these HPV 16L1 fragments that were found to be bound to aluminum in Gardasil. If there is HPV L1 fragments in the blood stream bound to aluminum (which has a half life of years) how would the macrophages be able to get rid of it? They eat this complex and my daughter’s immune system is going CRAZY on her….very likely that her blood brain barrier could be open. What happens with this soup of biochemistry? If you would have fully studied it MERCK, like you should have been obligated to do maybe you would know!
I should NEVER have given her those shots because you don’t have a CLUE what is happening inside her. I should NEVER have listened to your stupid one less commercials! You lied to me! My daughter will not be sexually active with in the 5 years it has been proven to be effective, my daughter has received this vaccine for absolutely no benefit and received a so far permanent autoimmune disorder because of it. That is not the worst part. Being abused by the medical field as you go from dr. to dr. and ask for help and they look at you and shrug their shoulders and call it insidious. I asked the rheumatologist “This vaccine is injected into the muscle….and then WHAT HAPPENS? What in this vaccine has caused my daughters illness?” He leaned forward and said to me “We are still going to have patients get this vaccine” That is a true story I even documented it in my letter to VAERS. (I requested 5 times, by the way, for my dr. office to report this to VAERS but I have looked and there is nothing from them. This just confirms what I am telling you. No one will admit it, it doesn’t matter if symptoms are due to Gardasil or not it will be refused until you get a lawyer. So when the CDC states they are doing research they are it does not include following up on these cases. They are telling all dr.s that there is no possibility beyond immediate reaction that symptoms are caused by Gardasil because that is the only thing they list on the CDC handout. It states hypersensitivity……then immediately talks about allergy. No one is suspecting an immune response within weeks that may be caused by Gardasil causing the child to be revaccinated with a vaccine that is already causing a drug reaction. I should not have to explain to anyone why this is dangerous or how disgusting it is that no one is addressing this problem. My face went white when the rheumatologist said that to me and my daughter and I got very quiet. I now knew that the government, the physicians knew these injuries were happening and they do not give a crap! They do not have any concern what so ever for the injured accept to try like heck to discredit them. I had nightmares for days knowing now just what kind of medical field we have in the United States and how tightly it is all connected to money. I let the supervisor of that office know I would never return and why. That was a very hurtful and devastating thing to say to a mother and child who are going through the worst situations in their lives. I read the stories of the 2 girls that died. I was so scared. I didn’t want to leave her side. I couldn’t sleep, was up at 4 a.m. every morning. I found a support group on Facebook with other mothers who’s children are going through all kinds of illness after Gardasil and they are petitioning the vaccine court. Their concerns are real, they are all autoimmune and neurological and all symptoms started with in weeks of Gardasil. PLENTY of injured that I know never got a lawyer. They have accepted their fate and do not want to fight. Some have chosen not to even report it. Still many never figure it out. (Good job MERCK, CDC, FDA in injuring these people and then making them feel like there is nothing they can do about it and so just accept their fate quietly. Your mission accomplished.) They are all devastated with the way they have been treated by the medical field and the way the CDC, FDA, MERCK all keep pushing this vaccine Gardasil on unsuspecting families that have no idea its efficacy is limited, and it is causing injury to thousands. You cannot discredit thousands I’m sorry. There are multiple mothers I have been speaking to who’s child has hives and angioedema…HUNDREDS who have fatigue and joint pain, seizures, their symptoms started in a reasonable amount of time to suspect molecular mimicry.
STOP denying us. Stop pretending that you are not withholding information that you KNOW this vaccine is causing injury. Cover up is the name of the game. So far that is my biggest lesson in all this…. vaccination is a big game. Provaxers using fear mongering to vaccinate no matter if it kills you or causes injury you MUST do it to protect everyone else. Anti-vaxers saying every vaccine is causing every disease. As a nurse I don’t know what to believe any more about vaccines and I am disappointed in the CDC for causing all this confusion. When you hide information that makes it confusing if the CDC really cares about the public or cares about money. That goes for the FDA and government officials as well (Rick Perry.) I was taught to believe the CDC FDA for sure that is where I look to guide me. But now I am in an awkward situation because I have seen firsthand how the CDC and the FDA can be corrupt. I have been studying Gardasil for months; I have seen the CDC hand out. Side effects from Gardasil are being hidden in the package insert and withheld from the public so that they will continue to get the shot. Most mothers would not give their child the Gardasil vaccine if they know it was only proven to last 5 years in girls and 2.5 years in boys. If they knew it was causing thousands of injuries world wide and is currently connected to over 126 deaths in the U.S. 8 boys have died since introduced to boys and they have been reported as their loved ones believe their death is due to the Gardasil vaccine.
I know some really aggressive jerk is going to come on after me and discredit all these claims including mine and say that Gardasil is safe, that we are all liars and just trying to get money from vaccine court (which by the way I had no idea existed before my daughter was injured.) For anyone who cares about our youth I am here to tell you that anyone telling you that there are not real concerns about Gardasil safety is lying to you.
Shaw and Lee, from what I can tell so far, are trying to figure out why Gardasil is causing so many injuries and death. If you are going to discredit them….why don’t you yourself try to do some research into why all these people are having reactions to Gardasil. The CDC does not care as far as I can tell. My daughter has been injured and continues to be injured; it has been over a year since her first shot. I have NEVER received one phone call from the CDC or MERCK to see how we are doing, investigate how we might want to learn from this so that if another child reacts with a blistering rash within 4 weeks after the vaccine we maybe shouldn’t vaccinate them again? If hives start developing and don’t go away before the next shot is due maybe Gardasil should NOT be given again? Unfortunately the CDC and the FDA and MERCK care not. So it is up to us anti vax moms (which is a bull crap word anti vax. I am pro comprehensive personalized care for all human beings) to warn as many people as possible about the vaccine. And that’s where, in my opinion people like YOURSELVES are creating “anti-“ mothers who are now very angry with the way they are treated by doctors who are trained from the very top to deny any vaccine injury. They no longer trust the CDC FDA or pharmaceutical companies or their doctors. Because they have seen firsthand that when it comes to a vaccine…..If your child is hurt…….what they all want you to do is accept it and be quiet about it….For the Greater Good.
Because Gardasil efficacy is so low ESPECIALLY IN BOYS you will never get herd immunity. When you start to really dig into how much money is made in the vaccine industry you start to really understand how insignificant your child really is to the government or the pharmaceutical company. Your child really means absolutely nothing compared to the billions of dollars brought in by this vaccine Gardasil. I wish the CDC and the FDA and MERCK would focus a little more energy trying to find out why these injuries are occurring, how to make the vaccine more safe and how to help the injured. The CDC could do many things right now to help avoid these injuries from continuing at the rate they are, but sadly this would decrease the revenue of the vaccine and so we come full circle.
You (pro vax) don’t want me (anti vax) to believe these rDNA fragments are causing this disease in my child then tell me how is Gardasil causing vaccine injury and stop denying that it did. You are creating these situations (anti vax moms, vaccine hysteria ect) by denying the truth….. 4 months ago I vaccinated all my children….now ….after this experience….I will never vaccinate any of them ever again. STOP creating people like me if what you think is important for the world is for as many people as possible to get vaccinations. If this vaccine injury was treated correctly it would only be me not vaccinating. But because of the nightmare I have been through I tell everyone I know for fear that if I don’t…this is going to happen to someone else. There are very few allowed on TV to tell people the truth and that is Gardasil is causing autoimmune disease, autoimmune initiated neurological disease and death in some people and the efficacy is 5 yrs in girls and 2.5 yrs in boys. Most people, (especially after doing their own research including researching Diane Harper) change their minds very quickly about Gardasil. Stop using mothers fear of cancer to shove snake oil at them! Gardasil is a lie! It doesn’t protect anyone from cancer, you can still get HPV 16 and 18, plenty of girls on the Gardasil sites have been dx with cervical cancer, in fact you can see them on the VAERS website. In my opinion the way this vaccine Gardasil is being handled is going to jeopardize the entire vaccination schedule because it is causing mothers to really look hard at each vaccine.
Why should I have vaccinated my child against Hep B as a baby? This vaccine is famous for not being effective, I was vaccinated and had a titer and the vaccine failed in me. Now that I have spoken to other nurses it does not “take” in many of us, I have counted 15 so far. It lasts what max 10 yrs? That vaccine tops the VAERS complaints. Why give it? A child under 10 has almost no chance of being exposed to Hepatitis B and that vaccine has aluminum in it which hangs out in the body for years. It can have an accumulative effect. Maybe you can explain to me why this should continue? Or what is wrong with this information that I have learned. Because many health care providers and mothers who are having babies are not wanting to vaccinate with Hep B anymore. Should we not draw more titers to see if we are vaccinating with aluminum for no benefit? Risking injury for no benefit?
I also want to comment on the mask wearing as I am a nurse. I do not want to get the flu shot because it has toxins in it that I don’t want in my body and because it does not work worth a crap. How I know that is that I work in multiple nursing homes where everyone is vaccinated including staff and then the flu is detected (every stupid year) and then the whole house gets Tamiflu! It happens every year! The flu vaccine does not protect against all flu and if your not sick don’t wear a mask nurses! It is a barrier to care, the patients and families express concern about these masks and do not like it that we wear them. They are uncomfortable and hard to breath with them. They are a barrier to good emotional and spiritual support and communication. Especially to a French speaking population like we have in Maine. They need to see our faces and our mouths as we are talking. If I was sick I would wear a mask no matter what virus I had that could be passed by droplets including the cold viruses which can also be very dangerous to patients. The forced mask wearing is another layer of control surrounding vaccination. It sues the facts about what giving excellent care entails. When you come down to the real world level and you deal with patients and families face to face you will find even people who want to get their vaccinations do not have this blind faith that vaccines are right for everyone or that everyone should get them no matter what. It is my opinion that the aggressiveness of the vaccination scare mongering is the strongest proponent of anti vax population. Not because they see anti vax as right and pro vax as wrong but because they see the corrupt actions of the pharmaceutical companies and the CDC and they don’t trust what they are doing or saying. Going overboard is causing doubt. From my perspective pro-vax is creating anti-vax. What we need are professional people interested in excellent INDIVIDUAL COMPREHENSIVE care. Not mass blind vaccination no matter what the situation. In continuing this way the “pro- vaxers” are going to create their own nightmare. A large population of people who no longer trust and who don’t want t be vaccinated.

@ Steve J; Lee cites AF125673 as being an exact match but that doesn’t show up in my BLAST inquiry even though it does have homology with other L1 gene sequences. That is what I don’t understand.

She ended up with a shingles dx and a recommendation: “don’t look on the internet this has nothing to do with Garadsil”.
3 weeks after the second shot she developed hives. The hives never went away. Her immunologist said there was no connection to Gardasil and thought she should get the third shot so that she could be protected from Cancer. She got the third and final shot on July 11, 2012.

I can’t stomach your wall of hysterical text so I will just address this for now. How do you blame Gardasil for shingles and hives three weeks after the fact? This is precisely why no one believes you as you can’t even provide biologically-plausible evidence. Do you realise that these things happen to girls who have never received Gardasil?

These people have her entire medical record and I have given them all the information from Diane Harper as to the efficacy problems and the safety issues as she has stated Gardasil does cause autoimmune disease, it does cause death and it did cause both of those in clinical trials, and it was placed on the market without being fully tested.

With the exception of Dr. Harper’s criticism that the vaccine was being marketed too aggressively, the rest is pure bollocks. Deaths occurred in both Gardasil and placebo groups and there were no patterns in either and Gardasil was never proclaimed as a COD in the recipients. You’re just another ranting anti-vaxx loon and I can only hope your daughter is under proper medical care and not some charlatan you doctor-shopped for.

They are uncomfortable and hard to breath with them. They are a barrier to good emotional and spiritual support and communication. Especially to a French speaking population like we have in Maine.

Beg pardon?

Jess, your daughter was diagnosed with shingles, caused by the Herpes Zoster virus. Are you accusing the Gardasil vaccine to be contaminated with herpes? If not, what other mechanism do you propose for this occurrence? You blame your daughter’s symptoms on an overstimulated immune system, while shingles usually is blamed on a weakened immune system. As your proposed causality chain runs contrary to medical experience, it would indeed be hard for your doctor to warn you about it.

C’est vrai, Narad. Lots of French-speakers in Maine (it’s that rascally Canadian border being so close).

Just about the only verifiable statement in Jess’ effluvium, though (maybe I work with a higher standard of RNs but I can’t wrap my brain around a nurse claiming that a vaccine is full of toxins).

That entire wall of blather can be summed up in five words:

Post hoc ergo propter hoc.

And that’s even leaving out the numerous gross factual inaccuracies.

Denice:

Yes, you’ll be fine. There’s no need for vaccines ever because natural, Gaia-blest healthy immunity wards off viruses and bacteria. And clean-living, I forgot that.

And only playing on the sidewalk, of course.

(One Internet cookie for who gets that reference first)

lilady,

I think this says it all about Jess’ story, whose link you posted:

My 15 year old was inoculated with Gardasil on December 29, 2011. On January 28, 2012, Mickayla was diagnosed with shingles. I told her provider that the only thing that was different in her internal or external environment was the Gardasil shot. The provider said it wasn’t connected.

Yup. That doctor was quite correct. Not only was Mickayla diagnosed nearly a month after being vaccinated with Gardasil, making Jess’ “connection” not even a convincing correlation between vaccination and the adverse event blamed on the vaccine, but Gardasil doesn’t cause shingles nor is there any plausible mechanism by which it could cause shingles unless the lot Mickayla was vaccinated from was contaminated with the Herpes zoster virus.

The rest is chasing shadows.

I should NEVER have given her those shots because you don’t have a CLUE what is happening inside her

But you totally do, right?

My daughter will not be sexually active with in the 5 years it has been proven to be effective

Yeah, right…you definitely do not know this for sure. Especially If your daughter received her vaccine at the recommended age of 11-12.

Because Gardasil efficacy is so low ESPECIALLY IN BOYS you will never get herd immunity.

Citation please.

What we need are professional people interested in excellent INDIVIDUAL COMPREHENSIVE care.

Care to expand on this?

Orac quoting Jess:

My 15 year old was inoculated with Gardasil on December 29, 2011.

That would mean she was born around 1996, only a year after the varicella vaccine became available. So it is quite likely the young woman got chicken pox at a young age, which makes it more likely for her to get shingles early.

My daughter got chicken pox as a six month old baby, and it could happen to her at any time. Especially now that she is dealing with college stress.

Especially to a French speaking population like we have in Maine. They need to see our faces and our mouths as we are talking.

French;speakers are not deaf; they do not need to lip-read. Nor does it help to shout at them.

What is it about Health care that attracts all the Typhoid Mary wannabees, demanding the right to be paid to work with sick people while exempting themselves from measures to limit infection?

I expect to hear any day now that having to wash one’s hands is also a violation of some nurse’s personal beliefs.

could a blistering rash be a drug reaction? Could a provider be wong with dx a blistering rash as shingles when It may be a drug reaction? They Injected that drug again and again left her a mess.
Typical of you to abuse the injured and call her mother “looney” just because it is a vaccine injury. I never knew just how ugly this whole thing was. I would have never guessed in a million years that as a nation we would treat patients and famlies harmed by a vaccine like this! It does sound crazy….. because it is! The whole thing has been unbelievable! …all of it….for every one of us!
The french community in Maine are hard working, family oriented people. It is a joy and a privledge to serve them.
Take No responsibility for what you are creating and you will continue to grow…this anti vax movement.

I admit that my expectations are not high for someone who called her daughter ‘Mickayla’.

Just about the only verifiable statement in Jess’ effluvium, though (maybe I work with a higher standard of RNs but I can’t wrap my brain around a nurse claiming that a vaccine is full of toxins).

Nor one who doesn’t grasp that Hep B vaccine doesn’t confer lifelong immunity and requires boosters and one that doesn’t grasp that many infectious diseases are transmissible prior to symptoms.

C’est vrai, Narad. Lots of French-speakers in Maine (it’s that rascally Canadian border being so close).

I’m aware that there’s a French-speaking population in Maine, although I’d guess the exclusively Francophone part is quite small. The point, however, is that claiming that masks present some sort of special obstacle to “emotional and spiritual support” because someone can speak French is nonsensical.

@ Stu:

“And only playing on the sidewalk, of course.”

“(One Internet cookie for who gets that reference first)”

I’d prefer to have a chocolate chip cookie, Stu…

http://www.sciencebasedmedicine.org/index.php/some-flu-vaccine-updates/

# Th1Th2on 10 Oct 2010 at 2:50 pm

Chris,

“(oh, sure… you would probably never let a kid near dirt, as that contains tetanus spoors and, quelle horreur, aluminum!).”

Why should I let the child walk on the dirt when there is a dry concrete pavement next to it? A toddler would readily know which is the safe path to take even without the knowledge of C. tetani, but I am just fascinated how parents are offering very poor choices (or lack thereof).”

@Jess

Except that you have not shown that the vaccine was the cause. You think it was, but you have no proof.

And as for your calling for nurses to not wear masks? Why do you not care about your and other’s patients? You realize, do you not, that when it comes to the flu (among other diseases) you are contagious before you show any symptoms? Barriers like that are to not only protect you from patients and visitors, but also to protect them from you.

I hope that I never have to receive care in your hospital.

while shingles usually is blamed on a weakened immune system

My first attack of shingles, the other people in the office where I worked at the time found it a great cause for hilarity. “But that’s for people under stress! People who work too hard!” Oh how they laughed.

Typical of you to abuse the injured and call her mother “looney” just because it is a vaccine injury.

Perhaps you should consider the possibility that your semicoherent wall of rant is the reason you were described as “just another ranting anti-vaxx loon.”

Could a provider be wong with dx a blistering rash as shingles when It may be a drug reaction?

Could a mother be wrong with dx a blistering rash as a drug reaction when it may be shingles?

Ok, so I have no kids but I do have a couple dozen nieces and nephews*. Stating that your teenaged daughter will not be sexually active in the next five years is weapons-grade wishful thinking.

*s’truth. I have six siblings, I married a man with six siblings.

So why don’t nurses who DO have the flu shot have to wear a mask? The nurses who recieve the flu shot……Guess what? They caught the flu! Just becasue you have the flu shot does not mean you wont get the flu! So we should all wear masks all the time.

They Injected that drug again and again left her a mess.

So says you except shingles and hives weeks post-vaccination are not vaccine injuries. You have yet to explain how they are.

Typical of you to abuse the injured and call her mother “looney” just because it is a vaccine injury. I never knew just how ugly this whole thing was.

Someone who came here with in incoherent screed calling us idiots? How rich.

Take No responsibility for what you are creating and you will continue to grow…this anti vax movement.

I’m sure you have convinced yourselves of that communing in echo chambers as you do but no, most who even know about your little “movement” think you’re whack. You do yourself and your daughter no favours by deluding yourself of the cause and ignoring sensible physicians who just won’t tell you what you want to hear.

I was under the impression “long lasting” on the CDC hand out ment over 10 years. If I knew a head of time that the vaccine only was proven to last for 5 years I would have never given it to her. Especially after the first reaction. It is wrong to hide that information from the public.

Molecular mimicry can takes weeks to show symptoms and that is one of the ways vaccines can cause injury. Molecular mimicry. do you dipute this?

Do you dispute that Gardasil has not been proven to last beyond 5 years in girls and 2.5 years in boys?

Jess, surely you’re not suggesting that being immunized against influenza shares causes you to be infected by influenza. Are you?

And while immunization cannot guarantee you’ll develop a protective antibody response the 2012 flu vaccine has been found to be 67% per cent effective at preventing the flu.

Molecular mimicry can takes weeks to show symptoms and that is one of the ways vaccines can cause injury. Molecular mimicry. do you dipute this?

Please stop abusing terms you know nothing about just because you read it somewhere and it sounds nifty. How would this cause shingles? Hives present within days, not weeks as a reaction to something. Too bad you keep tilting at windmills and stunt your search for what really may be happening.

why does the CDC recommend boys get Gardasil at 9 yrs old and then at the same time recommend Gay men get Gardasil at 26 yrs old?
How does Gardasil protect a 11yr old boy from cancer if he does not have sex until he is 16?

why does the CDC recommend boys get Gardasil at 9 yrs old and then at the same time recommend Gay men get Gardasil at 26 yrs old?
How does Gardasil protect a 11yr old boy from cancer if he does not have sex until he is 16?

Jess,

Do you dispute that Gardasil has not been proven to last beyond 5 years in girls and 2.5 years in boys?

Yes, it lasts at least 8 years and very probably much longer.

Gardasil and Cervarix are highly effective in preventing infection with the types of HPV they target. The vaccines have been shown to provide protection against persistent cervical HPV 16/18 infections for up to 8 years, which is the maximum time of research follow-up thus far. More will be known about the total duration of protection as research continues

Molecular mimicry can takes weeks to show symptoms and that is one of the ways vaccines can cause injury. Molecular mimicry. do you dipute this?

Dispute what, exactly?

If you would define exactly what you mean by ‘molecular mimicry’ as used here, demonstrate that vaccines do indeed cause injuries beyond their known (and minor) side effects, and explain why you believe those vaccine injuries are a function of this ‘molecular mimicry’ I’ll be able to determine if I agree or disagree.

Until then it’s just so much word salad.

The flu showed up regardless of vaccination. That I can tell you. Maybe a different strain? I would rather take my chances then to inject toxins into me.

Jess,

I suggest you re-read Mu’s comment
(January 10, 2013).

Until you tackle the key points, e.g. that shingles is caused by the Herpes zoster virus not HPV (Human papillomavirus) the rest isn’t helping yourself.

Similarly, it has been pointed out that hives occur as a rapid response, not weeks later.

I would rather take my chances then to inject toxins into me.

You get toxins in you every time you eat, breath, drink and get sick. Your ignorant use of “toxins” doesn’t exactly give you much basis to criticise those with far more knowledge and expertise than you have.

Krebiozen, This is interesting and information to me As I have never seen this anywhere. I have never seen anywhere that Gardasil lasts for 8 years in Males and Females. Tell me more.

Thermasol. is a toxin is it not? Should I not be concerned about repeated doses of Thermasol?

Jess,

” I have never seen anywhere that Gardasil lasts for 8 years in Males and Females.”

It actually says Gardasil protection lasts at least 8 years and possibly (likely) longer. Monitoring it over time will show how long the protection the immune system develops from the vaccination actually lasts.

I’m not just nitpicking. If you got you earlier quote of shorter times from when they’d only monitored for 5 years in girls and 2.5 years in boys, it would just be how long they had monitored it not how long the protection lasts, but you presented it a the former, not the later.

@Jess,

“If you got you earlier quote” should read “If you got your earlier quote”, sorry.

Nice segue there Jess…You’re the one who came here with your rants about Gardisal and now you’re attempting to discuss influenza.

Still to your original rant and tell us why you think shingles is associated with the HPV vaccine your daughter received.

You also stated (that), “Yes I have a lawyer and yes I have it in writing from an expert that Gardasil is the cause of my daughter’s urticaria and arthralgias.”

Which “medical expert” put that in writing and which “medical expert” will be testifying in Vaccine Court on behalf of you and and your daughter?

http://sanevax.org/medical-professional-listing/

Thermasol. is a toxin is it not? Should I not be concerned about repeated doses of Thermasol?

It’s thimerosal or thiomersal and no, it’s not toxic in the amount in a vaccine. Do you understand anything about dose curves?

“that vaccines do indeed cause injuries beyond their known (and minor) side effects,”
Vaccines are KNOWN to cause injury by way of molecular mimicry, Including hives, wheals, joint pain, angioedema, dermatogramphism. It can take weeks for the body to work upon the drug and develop symptoms. I do not KNOW in depth how this happens but YOU do. So keep denying it. There is no end to the lies.

no I dont, and I was never ment to! I am here to serve as a humble nurse and YES trust you people to protect me and my community and my children.

@Jess

Should I not be concerned about repeated doses of Thermasol?

Unless you’re eating it or working with industrial amounts of it, no. It is not toxic to humans at the amounts found in thimerosal-containing vaccines.

And if you are really that scared of thimerosal, ask for thimerosal-free versions of the vaccines. Pretty simple, really.

And regarding getting the flu after getting vaccinated against it, here are a few points to keep in mind. First, if you are exposed to influenza before you get the vaccine, you will get influenza. If you are exposed to influenza within the first 1-2 weeks after getting the vaccine, there’s a good chance you’ll get influenza. These are both true because, in the first case, you don’t have any immunity before the infection, and in the second, the vaccine takes around 2 weeks to become effective, meaning, no immunity until then. Then there’s possibility three: strain of influenza not in the vaccine. And possibility four: not influenza.

Lots of people say they got the flu after getting the vaccine, but without lab confirmation, it’s impossible to say with certainty that it was, indeed, influenza.

YES trust you people to protect me and my community and my children.

So you’re relying on us to provide herd immunity so you can be a scab?

“Gardasil does cause autoimmune disease, it does cause death and it did cause both of those in clinical trials, and it was placed on the market without being fully tested.”

Four for four – all wrong. Gardasil has been linked to none of those conditions, and it had extensive testing prior to marketing (“fully” tested is a meaningless criterion until you define what “fully” means).

” yes I have it in writing from an expert that Gardasil is the cause of my daughter’s urticaria and arthralgias.”

Who is this “expert”?

” I do not want to get the flu shot because it has toxins in it that I don’t want in my body and because it does not work worth a crap. How I know that is that I work in multiple nursing homes where everyone is vaccinated including staff and then the flu is detected (every stupid year) and then the whole house gets Tamiflu! It happens every year!”

Your anecdotal observations do not conform with hard evidence to the contrary.

“In nursing home settings, vaccination of health care workers has been shown to decrease morbidity and mortality among nursing home residents”

h_tp://cid.oxfordjournals.org/content/50/4/459.long

The real issue for Jess with influenza vaccination is that a) she’s scared of it due to antivax fears (i.e. “toxin”-phobia) and doesn’t want to wear a mask because it’s too uncomfortable. Jess needs to find a different career where she won’t put patients in jeopardy.

I have posted the following before, but it seems appropriate to repeat myself. Here’s an example of a human study in which 26 patients were given intravenous injections of between 4 and 734 milligrams (mean 157 milligrams) of thimerosal over periods ranging from six months to 17 years. Note that there is at most 0.05 milligrams of thimerosal in a vaccine shot. These patients were given between 4,000 and 734,000 micrograms of thimerosal directly into their bloodstreams (unlike vaccines which are mostly given subcutaneously or intramuscularly), that is between 80 and 14,680 times the dose of thimerosal given in a vaccine. The study concludes:

None of our 26 patients had overt clinical evidence of mercury toxicity. Neurological or intestinal symptoms that were present in our patients usually predated treatment and were attributed to the well-recognised complications of antibody deficiency. Three other patients (not included here) had uneventful pregnancies and gave birth to healthy children while receiving regular replacement therapy.

Jess, I’m sincerely wondering something. Do you think it is remotely possible that vaccines did not cause your daughter’s shingles?

Along the same lines, what evidence would (hypothetically) convince you that the vaccine did not cause shingles?

With all the talk about molecular mimicry I’m surprised she picked vaccines as the cause for her daughter’s symptoms, with arthralgias and living in the NE lyme would have been my prime suspect. But probably it’s too difficult to sue a tick.

@AdamG I am not sure my daughter had shingles. blistering rash occuring 3 weeks after vaccine could have been a drug reaction. Also, I could have put this out of my mind had she not then developed hives 3 weeks after the second injection and the worsening hives, dermatographism, joint pain, wheals, headache, nausea ect. ect.. 3 weeks after the third injection. There was no tick bite, there was nothing different except Gardasil. Why would I think anything else caused this? Tell me.

@Jess

Might I make a minor correction?

there was nothing different that I noticed except Gardasil

Gardasil was a much more unusual event, and so sticks out in your memory and among things you may have paid attention to. More mundane things could have slipped your notice or memory but still be a cause. And when you fervently believe that you just know Gardasil was the cause, you’re even more likely to dismiss and/or forget about other potential causes.

That’s entirely understandable. It’s a human trait. It doesn’t make you right, though.

@Jess – so absolutely nothing happened to your daughter over that period of time? Were you living in a cave?

There are a million potential variables – including a tick bite (which could be easily missed). Since the reactions you mention aren’t a known side-effect of Gardisil – you’re barking up the wrong tree.

Jess:
” So keep denying it. There is no end to the lies.
… I am here to serve as a humble nurse and YES trust you people to protect me and my community and my children”.

I infer that she doesn’t trust us, the experts, the medical establishment, universities, medical associations, research, journals, governmental agencies, the media et al.

I wonder where she gets ideas like this?** And why she trusts those who promote them? Why does that group of people over-ride what the experts et al say? They must be rather special to trump all that!

Woo and conspiracy symbiotically require each other to exist.

** rhetorical question.

Vaccines are KNOWN to cause injury by way of molecular mimicry, Including hives, wheals, joint pain, angioedema, dermatogramphism. It can take weeks for the body to work upon the drug and develop symptoms. I do not KNOW in depth how this happens but YOU do. So keep denying it. There is no end to the lies.

More like there is no end to anti-vaxx ignorance and sleazy operators like SaneVax “experts” to prey upon them.

Jess, you can’t even reason out shingles post vaccination and hives a ridiculous amount of time post vaccination. How do you know your daughter didn’t have an infection? You don’t even know what molecular mimicry is but are convinced that Gardasil caused this. It’s preposterous.

Take a look at SaneVax’s “experts”; they are charlatans running their own clinics treating “vaccine damage” with no expertise; they are homeopaths and chiropractors and they are liars like Lee (he is no longer at Milford hospital but represents himself as such) and Carly who makes it sound as though she left medicine voluntarily but was actually de-licensed because she is literally crazy.

Your daughter looks lovely and has a bright future ahead of her if you let her; stop victimising her and letting SaneVax exploit her. Instead why don’t you work with reputable doctors and keep your eyes open for clinical trials?

Angioedema….Her entire back was one giant hive. She has no history of this occurring ever in her life. Are you really suggesting Gardasil had nothing to do with her symptoms? Keep lying to yourself. She is not one in a million either. Doctors have tried to tell me that too. There are many people hurt by this vaccine. But you will all deny it to the end

@Jess

But you will all deny it to the end

As long as you keep asserting things without evidence or plausibility, yeah. You want us to believe you or change our minds, give us some evidence.

Thank you for the comment about my daughter. She is lovely. You say SANE VAX exploited her, I don’t believe that to be true. I was able to tell her story, I knew people would see it in case it happens to someone else. If you read the comments under the article you will see she is not the only one that this has happened to. I am a nurse. Damn it I want to trust the people who have been the influence of my learning for the last 19 years. I saw what happened in front of me AS DID MY WHOLE TOWN. My lovely daughter with a lovely name Mickayla did not deserve this. We should have stopped vaccinating her after the blistering rash. MOST DEFINATELY after the hives. Now there is no turning back and she is struggling to stay in school. What I need to do is stop trying to convince people like who are lining their pockets with vaccine money that their product is causing disease because you will obviously never admit it. You wouldn’t care if was or not as long as the money keeps rolling in.

Angioedema….Her entire back was one giant hive. She has no history of this occurring ever in her life. Are you really suggesting Gardasil had nothing to do with her symptoms?

I tore off a toenail this morning stubbing it into the exposed ends of my newly laid laminate flooring, right after I had an egg salad sandwich. I have no history of this occurring ever in my life. Are you really suggesting that egg salad sandwiches had nothing to do with my symptoms?

By the way: lilady wins one giant, fresh, warm, chewy Internet chocolate chip cookie. Ah, Th1Th2… those were the days.

@Jess

What I need to do is stop trying to convince people like who are lining their pockets with vaccine money

You’re suggesting that we’re in the pay of Big Pharma and that’s why we’re disagreeing with you? You keep telling yourself that so you don’t have to consider that we are people who care about the facts and reality.

I can’t speak for others, but I do not derive any income from vaccine companies or from the sale of vaccines. But if it helps you feel better about dismissing anything I have to say out of hand rather than dealing with reality, then fine. It’s a sad, blighted way to go through life, but that’s your choice.

With all the talk about molecular mimicry I’m surprised she picked vaccines as the cause for her daughter’s symptoms, with arthralgias and living in the NE lyme would have been my prime suspect. But probably it’s too difficult to sue a tick.

@Mu, No, the Lyme crowd is trying to start a class action suit against the IDSA. or the feds.

I saw what happened in front of me AS DID MY WHOLE TOWN.

Except, of course, for your town’s doctors. Wonder why that is?

What I need to do is stop trying to convince people like who are lining their pockets with vaccine money

Where is all this vaccine money I’m supposedly lining my pockets with? I’m a PhD student who makes about as much as a fast food manager!

@Science Mom
“Lee cites AF125673 as being an exact match but that doesn’t show up in my BLAST inquiry even though it does have homology with other L1 gene sequences. That is what I don’t understand.”
The same here. The HPV16W12E strain he cites is one that grows in tissue culture (Virology 262, 344-354 (1999)). Maybe he has those growing in his lab, so he had the accession number handy?

You say SANE VAX exploited her, I don’t believe that to be true.

What you believe has nothing to do with it. I’m sorry, that’s just not how things work. Just because you believe vaccines harmed your child because she had (COMPLETELY UNRELATED) symptoms around the time she was vaccinated, and because you really, really want to believe that there is a simple explanation for this, and because you really, really want to believe there’s a great big evil something somewhere to blame for this…

…still does not make it true.

If you read the comments under the article you will see she is not the only one that this has happened to.

No, we see you are not the only parent desperately clinging to a faulty explanation for your child’s ills because it makes you feel better.

I am a nurse.

Sorry, nobody cares.

What I need to do is stop trying to convince people like who are lining their pockets with vaccine money

Are you implying we are those people? Sorry, no. Haven’t gotten a check ever. Also, for drug companies, vaccines are bad products. Between the low margins and the liability hysteria, some governments actually have to force drug companies to keep making vaccines, or subsidize production.

The money is in dick pills and antidepressants.

that their product is causing disease because you will obviously never admit it.

Obvious and stupid lie. Vaccines, in very rare cases, cause serious harm to people (usually, people with undiagnosed and extremely rare issues with their immune system). Nobody is denying this.

You wouldn’t care if was or not as long as the money keeps rolling in.

Still waiting for that first check.

http://vaccineliberationarmy.com/gardasil-deaths-account-for-over-60-of-all-vaccine-related-death-reports/
So sad to me that so many choose to be blind. My daughter has been suffering almost 2 years, SICK the day OF Gardasil that lead to 17 days in the hospital, the doctors agree Gardasil did it. Did I mention they tested her for Heavy Metal Poisioning, she was what the doctors called “TOXIC” with aluminum, look up Gardasil Ingredients, then do some research. Knowledge is Power & Oh can save your childs life. Jess thanks for at least trying to save others from this devastating worthless vaccine!

You say SANE VAX exploited her, I don’t believe that to be true. I was able to tell her story, I knew people would see it in case it happens to someone else.

You’re welcome, I really mean it and I think it would be a shame for your daughter to grow up feeling like a victim and bearing your anger. SANEVAX is exploiting her; the more “stories” they collect, the more validated they feel. It’s like a perverse pyramid scam. Please remember that you are a story as others are but your stories simply don’t have any biological plausibility and you are victims of repetition confirmation.

My lovely daughter with a lovely name Mickayla did not deserve this.

No child deserves suffering ever but do you really believe that your crusade benefits anyone but you and only temporarily? There are university teaching hospitals with research physicians who may help you and your daughter. Please don’t turn to these charlatans for answers; you are in for tremendous disappointment.

What I need to do is stop trying to convince people like who are lining their pockets with vaccine money that their product is causing disease because you will obviously never admit it. You wouldn’t care if was or not as long as the money keeps rolling in.

None of the regulars here including me are in the thrall of pharma. Our host blogs for Nat Geo pittance and some of us have our own blogs that we maintain out of our own pockets. We disagree with you; that’s all. There is no financial gain for us.

@Jess – the ole’ Pharma Shill Gambit, it was old a long time ago, no better today….

“Except, of course, for your town’s doctors. Wonder why that is?” dont speak so soon. There are more providers in my area then the ones who treated my daughter during her injury. There ARE doctors who believe that Gardasil did cause her injury and they are local. They do not promote the Gardasil vaccine. Some never did and some did and stopped after Mickayla’s story coupled with their own research.

Lee cites AF125673 as being an exact match but that doesn’t show up in my BLAST inquiry even though it does have homology with other L1 gene sequences. That is what I don’t understand

It’s not showing up in the top BLAST results, but local alignment of the 184 nucleotides against accession #AF125673 does indeed produce a perfect match.

Again, I understand the skepticism, but let’s focus on the big flaw here: the origins of these sequences.

“I am a nurse”

And I am a nurse as well, Jess. Jeez, where did you get your education that you don’t know that shingles (herpes zoster), is caused by another virus?

You need to develop some research skills and not rely on all those anti-vaccine websites which are your sole source of information.

@ Stu: Insane Troll is haunting the Shot of Prevention blog; posting under various ‘nyms. She’s learned how to use a different IP address.

Some never did and some did and stopped after Mickayla’s story coupled with their own research

Yeah, OK. I’m betting that “their own research” = University of Google.

Jess,

Are you really suggesting Gardasil had nothing to do with her symptoms?

Yes. Gardasil is a remarkably safe and effective vaccine. If you look in the package insert (PDF) at the clinical trials which include tens of thousands of patients, the adverse events found in the test and control groups are almost identical. Also, the Vaccine Safety Datalink (VSD) uses active surveillance of hundreds of thousands of people to look for any adverse events associated with vaccines. They have found no evidence of the thousands of cases of autoimmune neurological disease you claim Gardasil has caused, or any other adverse events apart from minor reactions such as fainting and a small increase in the risk of blood clots in young women on the oral contraceptive pill. Rapid Cycle Analysis in 2011 concluded:

In 2011, VSD active surveillance (called Rapid Cycle Analysis) looked at specific adverse events following more than 600,000 doses of Gardasil, such as Guillain–Barré Syndrome (GBS), stroke, VTE, appendicitis, seizures, syncope, allergic reactions, and anaphylaxis. No statistically significant increased risk for any of these adverse events was detected after vaccination.

When you look at the ingredients of Gardasil, it seems extremely unlikely that it could cause the symptoms you describe. Apart from the HPV proteins that are produced using genetically engineered baker’s yeast:

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, <7 mcg yeast protein/dose, and water for injection. The product does not contain a preservative or antibiotics.

We all absorb more aluminum from our food every day than there was in all the doses of Gardasil your daughter received, and anyone who has a wart will be exposed to much more HPV proteins than there are in the vaccine, yet people with warts do not show the symptoms your daughter has suffered. Sodium chloride is common salt, histidine is an essential amino acid, polysorbate is a detergent similar to dishwashing liquid, sodium borate is available as a dietary supplement in much higher doses than there is in Gardasil, yeast protein is present in much larger amounts in bread and other foods, and all these substances are present in such tiny amounts I don’t see why anyone would be concerned about them. None of them are toxins in such tiny quantities. You and your daughter have clearly had a very unpleasant experience, and you have my sincere sympathy, but I think you are very much mistaken when you blame Gardasil for this.

Apologies for the link closing fail. The two links I intended to provide are intact.

Jess: I am severely allergic to any drug containing sulphur, and also really severely allergic to erithromycin – as in, stopped breathing, required hospitalisation to recover. The sulphur-drug reaction occurred within hours (fever, severe joint pain, nausea) and was on a list of known side effects I was watching for. The erithromycin reaction occurred within 30 minutes. *These* are the sort of reaction times that definitely lead to the conclusion it was the drug that caused the problem. Three weeks later? I’m sorry your daughter has suffered so much, but so much can occur within three weeks pointing the finger at the vaccine is ludicrous.

Eating and Injecting into the blood stream are 2 entirely different things and this I was told also by a neurologist who has treated many girls he believes are having a reaction to Gardasil. It is very apparent that no one here cares to learn the truth, unfortunately for some it takes having it happen to themselves or their child. I have had my kids go in for every scheduled, recommended vaccine all their lives . Gardasil truly almost killed my daughter. Don’t care to listen, Don’t care to believe , that is up to you, But in time oh in time this blog will be laughed at. Why?? you ask, the truth will be exposed, this I am sure of! Just hope I can warn others and I will every day, constantly till the day its off the market. Yes, Some moms do care. I have stopped 100s from having this vaccine. Do I regret it?? My God….NO. If you lived through what My daughter and I have, you wouldn’t either. No battle here with me. Some choose not to listen to others who have first hand knowledge, sad??? Yes.
You all really NEED to seek out answers, the truth and stop tearing apart a mother who has been through a certain Hell on Earth you would never want to experience. She is one of many and I mean one of thousand of moms , dads. yes dads believe it too, the saw it happen to their once healthy child. I know a man who had to see his on the bathroom floor Dead, 40 hrs after Gardasil. Another who has 2 girls who both got sick right after Gardasil, hmmm how does that happen??? they both get sick, same symptoms, only one thing in common GARDASIL. I know mothers who have children that had seizures immediately following the vaccine, IN THE doctors office, guess what 2, 3, 5 years later they still have seizures. oh but Merck does mention that as a side effect, as well as DEATH. SO if Merck lists it, why is it so hard for you all to believe it is happening. Does that make any sense? Get the Merck manual, read it!! I did and the side effects are all right there, the ones my daughter suffers with every day. geeesh its common sense!

You are now just flailing wildly, Jess. Try to stick to your own half-baked schtick before dredging up somebody else’s.

Jess, you have got to be kidding. This is what that site states in the “About us” page:

The Population Research Institute is a non-profit research group whose goals are to expose the myth of overpopulation, to expose human rights abuses committed in population control programs, and to make the case that people are the world’s greatest resource. Our growing, global network of pro-life groups spans over 30 countries.

I just clicked on one of their videos, and then the “actual science” link and pretty much got opinion:
http://overpopulationisamyth.com/content/episode-6-urbanization-whos-afraid-big-bad-city

Try again.

(Which probably is readily tied to COGforLife, which thinks the Rockefellers are at the bottom of it all and readily Godwinizes.)

Jess, enough with fingerblasting out links that you apparently can’t muster a coherent remark about.

my computer isnt working well and that first link was ment to be the second.

What, there’s supposed to be an order now?

I’m sorry,Jess, for what has happened to your daughter and for the treatment by Science mom, Todd and lilady. The latter is very nasty to anyone, obsessed with posting and tracking down who is who- she’s even dissed an adult with autism, maligning and speculating about his marks, courses and dating. I think she suffers from some sort of reaction- formation problem. I currently work as an Ed assistant and she disparages that fact all the time, which to me is indirectly insulting the kids I work with. The bottom line is that they don’t believe any adverse event can be related to a vaccine unless it maybe happens within 2 weeks. I’m not sure how they would know this due to the lack of physiological studies, though.

I think she suffers from some sort of reaction- formation problem.

Jen, did you pick up this term directly from Th1Th2, or is it just something diffusing through the crankosphere?

@jen

Considering your utterly tasteless and offensive comments on Huffpo that you made to the poster whose husband died from an HPV disease, I think you are an utter hypocrite and liar and that you deserve all the scorn that is heaped upon you that you truly deserve.

Of coursed, your earlier sockpuppeting and pseudoscience thinking also leaves you with no room for talking.

“I am severely allergic to any drug containing sulphur, and also really severely allergic to erithromycin – as in, stopped breathing, required hospitalisation to recover. The sulphur-drug reaction occurred within hours (fever, severe joint pain, nausea) and was on a list of known side effects I was watching for. The erithromycin reaction occurred within 30 minutes. *These* are the sort of reaction times that definitely lead to the conclusion it was the drug that caused the problem. Three weeks later? I’m sorry your daughter has suffered so much, but so much can occur within three weeks pointing the finger at the vaccine is ludicrous.”
Really?
What about Hypersensitivity reactions that are delayed. You are wrong.
My patients, my fellow nurses and my community know my nursing and know my heart. Not knowing me, it doesnt matter what you say about my nursing, I have been by the side of thousands in need and have always given 100% to to them. Many patients and nurses and fellow healthcare workers care very much about me because of that.
My decision to vaccinate myself or my children is NO THANK YOU. Scab or not I dont care this whole Gardasil crap has scared me to death. As it has many others. And caused me to question the entire vaccination program….as it has many others. The truth will come out eventually. This Gardasil vaccine is dangerous. I appreciate you recognizing how terrible this has been for my daughter. It has been a nightmare. If it is true that vaccines cannot cause injury with out symptoms showing for 3 weeks we will be turned away in vaccine court and so be it. So, lets just see what happens. There is so much documentation and expert witness name dropping that I am not going to do here. I am confident that the truth will be told.

could a blistering rash be a drug reaction? Could a provider be wong with dx a blistering rash as shingles when It may be a drug reaction?

A day or two later, maybe. Three weeks or a month later? No.

Shingles might be triggered by exposure to chicken pox. Did your daughter or you, or anyone else in the family, come into contact with anyone with chicken pox? I know some people have “pox parties” or send swabs through the mail to deliberately expose their kids, I take it you (or your friends, or your neighbors) weren’t doing anything like that?

Hives, now, too many possibilities. Change your laundry detergent, change your fabric softener, wear new (or secondhand) clothes without laundering them first, stay at a friend’s house where they use a different detergent on the sheets, eat something you’ve never eaten before – or have eaten before, and become sensitized to – drink something ditto,smoke or take drugs (fifteen, right?), some airborne contaminants, mites, even in a few cases contact with a new person. Did your daughter do any of these in the three weeks between the shot and the hives? Except really you should look at the three days before, because (as with the shot) hives develop soon after the exposure, not nearly a month later.

I do not KNOW in depth how this happens but YOU do.

Thank you for admitting you’re talking out of your ass Jen.

I have been by the side of thousands in need and have always given 100% to to them.

The immediate question is “100% of what?

Nope no chicken pox no nothing, no tick bite in the middle of freezing march, no insect bite of any kind no nothing. Nothing different NOTHING except gardasil. We will see……

Oh, and…

If it is true that vaccines cannot cause injury with out symptoms showing for 3 weeks we will be turned away in vaccine court and so be it. So, lets just see what happens.

Don’t forget to return with that case number.

I fully explained my mistake on the thread and apologized.

It must have been quite a work even by your standards, given a quick skim of the comments.

Jess: I did a few searches on pubmed, the first one being the HPV vaccine and shingles and the second was about the HPV vaccine and adverse effects.

The former search list one publication of a combination HPV+Herpes Zoster vaccine which is a free text. The later search is for all adverse effect publications related to the HPV with a total of 101 publications.

If shingles were an adverse effect of the vaccine, it would be found in the first link.

Alain

@jen

Your mealy-mouthed “notpology” really doesn’t cut it.

And considering your comments on this thread, I think you haven’t learned your lesson nor are you sincere in your apology.

But then again, it’s about par for the course for you.

Nope, sorry, still don’t buy the three week reaction time if it was hypersensitivity, Jess. I can’t find a single case of hypersensitivity that took that long to show up, unless it was prolonged, constant exposure.

Given chicken pox is highly contagious and can be transmitted by airborne droplets (that is, being sneezed on by a carrier) I still think you’re looking at the wrong culprit for what has clearly been a painful ordeal for your daughter.

Jess: There ARE doctors who believe that Gardasil did cause her injury and they are local.

Actual licensed doctors or naturopaths? There is a difference. Also, not every doctor is equal-as a nurse, you should know this.

Narad:

The Human Life Center is the predecessor to Human Life International, which actively promoted the tetanus/hCG sterilization story.

I have been reading some things about its present leader, Steven Mosher. With my library card I found several 1980s articles on the New York Times about his expulsion from Stanford while he was doing an anthropology PhD. He is a real piece of work from lying, bribery and not even writing an actual bit of science.

Here is a quote from the Sept. 30, 1986 article:

Mr. Kennedy, a defendant in the suit along with the university and members of the anthropology department, cited several instances of what he called unprofessional or deceptive conduct by Mr. Mosher. For example, he said, Mr. Mosher conducted research near Canton when he was supposed to be writing his dissertation about a fishing village in Taiwan. He said Mr. Mosher then submitted a ”popular ethnography of China instead of a scholarly demographic study of Taiwan” as his dissertation.

Hi jened…Fancy meeting you here.

“I’m sorry,Jess, for what has happened to your daughter and for the treatment by Science mom, Todd and lilady. The latter is very nasty to anyone, obsessed with posting and tracking down who is who- she’s even dissed an adult with autism, maligning and speculating about his marks, courses and dating”

You’ve got that wrong “jened”. I never “dissed” The Stalker about his marks or his dating. I’ve questioned The Stalker’s graduate studies at G.W.U. and also stated that he may be awarded a MPH-Epidemiology degree…but he will never be an epidemiologist.

Run along now, jen, jened, Sick Sauce. Do try to stick the flounce.

Yes I have a lawyer and yes I have it in writing from an expert that Gardasil is the cause of my daughter’s urticaria and arthralgias.

Sounds like Orly Taitz has branched into the field of health-care barratry.

Now I want to submit a VAERS report that says Gardasil turned me into a newt.

To any lurkers reading this: My father had some sort of allergic reaction to the tetanus-diphtheria-pertussis vaccine and can’t have any boosters anymore. That leaves him vulnerable to these illnesses.

Please do your part and get vaccinated. It protects you but it also protects people like my dad, too. We need that herd immunity.

@ Khani: Your comment is not off topic and the chances of contracting diphtheria is slim to none in the United States. Tetanus is not transmissible.

I contracted pertussis a few years before the Tdap booster vaccine was licensed and available. It is no picnic and I was put on an antibiotic while awaiting the positive naso-pharyngeal swab. (I did some arm-twisting to get the prescription…I *knew* it was pertussis, in spite of having no known contact to a pertussis case).

I was eternally grateful that I didn’t have contact with an infant prior to the onset of symptoms and the antibiotic eliminated the chance that I would pass the virus to anyone else.

I suffered through eight weeks of rib-cracking coughing, but with the help of a bronchodilator and two huge bottles of codeine cough syrup, I made it.

Yes, it is pertussis I’m worried about, with regard to other people. (I worry more about twigs and things with regard to tetanus.)

My dad is not in the best shape ever for a man his age and he does have a lot of contact with the public. He’s had bronchitis and pneumonia before and it took a long time to shake them both; I don’t want him to get pertussis because some ninnyhammer’s running around unvaccinated due to fictional “toxins” in amounts that wouldn’t hurt a mouse, let alone a very large adult human male.

Khani: I try to stay current on my boosters because my mother’s a nurse, and I currently work in areas where I encounter a lot of elderly people and young children. I also got the flu shot for the first time this year for that reason- and because I couldn’t live with myself if the elderly woman I cared for got the flu from me. It’s not about me- it’s about keeping people around me healthy.
Off topic- anyone else feel that the flu vaccine was extra stingy this year? I felt that thing for two days.

Wha -? I’m away from RI for a few hours and now find some nitwit dissing lilady. But lilady is educated, thorough, and correct in her commentary. She presents here as a compassionate & respectful person. But she has little patience for damn-foolery – hence the personal attack from jen, I reckon.

Jess: “What about Hypersensitivity reactions that are delayed. You are wrong.”
Nope, you are wrong again, and again, and again… Thirty seconds, 587 hits. Let’s just go with Wikipedia’s first line in the entry for Delayed Hypersensitivity: “Type IV hypersensitivity is often called delayed type hypersensitivity as the reaction takes two to three days to develop.”

Three weeks is not delayed hypersensitivity. Vaccines are not the same as “drugs” and do not cause rash-like “drug reactions”. Hives are not related to Gardasil or even full-blown HPV infection. If you bothered to spend even thirty seconds to ACTUALLY look up these terms you keep throwing out you’d realize why you sound so bloody ignorant.

@ politicalguineapig: My doctor gave me the intradermal influenza vaccine this year…and yeah it stung. My husband and I both developed itching, warmth and swelling at the injection site. Next year, I’m putting my order for the traditional shot.

http://www.cdc.gov/flu/protect/vaccine/qa_intradermal-vaccine.htm

@THS: “jen” has been engaging in some cyber stalking of me…she’s been doing it for weeks now. It really doesn’t bother me because I take it from whence it comes.

Jess – if you want people to take you seriously, should you not take facts seriously? I looked at your account of your daughter’s case. First shot 28 December: diagnosed with shingles 29 January. Well over four weeks. Second shot 29 February: hives by the end of March. A bit more wiggle room there, but still essentially four weeks. Third shot 11 July: physician appointment 15 August for urticaria. Exactly five weeks. Yet you repeatedly state three weeks for the onset of symptoms you’re convinced the vaccine caused. Surely you didn’t keep your daughter at home suffering for one or two weeks before seeking medical help. This is one reason anecdote is not good medical evidence.

I am tired of this, as is my mother. 1. Gardasil was fast-tracked, only proved to last five years in females and 2.5 in males. (Fact. Google it.) That doesn’t make Gardasil bad, it
s just a fact that the CDC for some reason did not want to share this. So we are. To everyone. Including those who are hard-headed.
2. You were warned. The point of telling people this was not to argue it, but to inform people who have had reactions that they are not alone. When I had a reaction to this, no one believed it. (Well besides the community, no doctors thought so) because they didn’t even know what the shot did. On the Gardasil website they say (look this up) Urticaria can be caused by Gardasil, it is a symptom of this shot, it can show up even many months after. Don’t believe it? Go to the website and look at it. It didn’t take me six years of med school to figure this out.
You may be a scientist but apparently you’ve lost your common sense. Three strikes your out. I had three immune reactions to three doses of Gardasil.
If you don’t believe it great. If this reaches some poor soul who feels alone and confused, that was my mothers point in posting here. She feels guilty because she made me get the shot. Her best friend is dying of cervical cancer, and she didn’t want the same to happen to me.
Now, sit here and say I’m talking crazy, I’m too young to understand what’s been happening to my body for a whole year, that I don’t know what I’m talking about because I’m not a professional. I obviously don’t care.
To anyone out there who is like me, there is help for you. There are groups on facebook for people who have been injured, even the government made a compensation program for people who have been injured (in the USA.) The government admits that vaccines can injure people obviously because the program was created.
As for everyone else, state your opinion as it is a free-country, but realize karma will always come back to bite you. My name, my religious practices, my everything is not your concern to pick at. None of it matters. The focus is what the vaccine has done, not what kind of person I am. It’s about the injuries it’s causing, and that people who were injured are not alone.
People who are sexually active should probably get the vaccine, but if you start getting hives, or other forms of reactions, don’t just brush it off because your doctor says it’s not Gardasil. My doctor apparently didn’t even read the website, and the specialist apparently didn’t either, becaue it’s right there in writing.
Go to Gardasil.com and look at the reactions list if you think you may have had a reaction. Also, don’t worry if it’s a month to two months after, Gardasil also says to look at these symptoms even if it has been months after, to tell your doctor as well, to not get another dose if you have had any other reactions. It is not worth getting the shot if you become injured for life.

@Jess: yes, we are denying that Gardasil is the *most likely* cause of your daughter’s health issues. AS A NURSE, you should know that severe reactions to allergens occurs within a very short (0-1 hour) time. Or have you never given a medication and seen a drug reaction? Or never seen hives before?

As far as blaming Gardasil: my teenage daughter broke out in horrible hives one day. Never had them before, nothing was new and different in her life. 2 years later she got the vaccine and every so often would break out in hives, pain, vomiting! I never knew Gardasil could cause hives BEFORE it was given…Oh wait. We discovered she was allergic to strawberries – after years of eating them without problems. Not the Gardasil. The ordinary, every day strawberry, present in many foods as flavoring. Fortunately, I don’t see conspiracies under every rock and we used medical testing to find out what was wrong with my undeniably beautiful, bright, healthy daughter, who got the full series of 3 vaccines (and all other vaccines up to date as she works in a hospital and believes in them), who has no problems except when someone slips strawberry flavoring into ANY food in any food.

Have your own beautiful, intelligent daughter tested for allergens and quit blaming the evil toxins. There maybe “evil toxins” in her life as there are in my daughter’s (strawberry flavoring is in a LOT of foods), but her problems are most likely NOT from the vaccine.

And, you said none of the doctors have filed a report to VAERS – why haven’t you? Anyone can file a VAERS report, you know.

Lastly – as one RN to another – please don’t embarrass us all by typing phlegm-specked walls o’ text. Show you are an intelligent, thoughtful, educated person who can write properly. We are far more likely to treat you like one.

Ah…I see I missed the comment where Jess is taking it to Vaccine Court – still, did you ever report it to VAERs yourself, Jess? And have you gotten a court case number we can follow?

@Jess

Regarding the hives, I would suggest that she get tested for chemical allergens. Fragrance would be one to definitely include. Just about everything in personal hygiene (laundry detergent, soaps, shampoos, deodorants, etc.) have some manner of fragrance in them. Even if you’ve used the same stuff for years, it could cause a reaction out of the blue one day.

The nurses and doctors in the thread can correct me if I’m wrong, but hives generally indicate an allergic reaction, no? With so many potential culprits in the environment, it may be difficult to pin down what she was exposed to, but it seems likely that it was some manner of allergic reaction, not vaccine-related.

(And on another note, Jess, would you please reconsider wearing a mask when working with patients? As I pointed out, it’s about as effective as the vaccine and, despite some minor discomfort, is a big help to keeping your patients, coworkers and yourself safe.)

Yes I did report it to VAERS, and to the CDC (who did not deny Gardasil could be the cause), MERCK didnt deny it either…do you know what the MERCK rep said to me? “You could have stopped her from getting the shot” All 3 immunologists that examied her did not state Gardasil was NOT the cause, the FDA did not deny Gardasil could be the cause, nor did her doctor nor did the rhumatologist. They could not rule it out. Neither can you. There are delayed immune reactions MI Dawn. You stating that delayed drug reactions do not exist shows how smart you are. They absolutely do exist and are well documented. I did not bring her to the dr. immediately for any of her reactions because they all started slowly and progressed over time. The time between the second shot and when I had her seen I was doing everything I could think of to get the hives to stop, no perfume, no lotions, no make up, washed everything with nonsented soap. She had 60 skin tests! She spent time at friends houses and my moms and even went to New York for a week with no change. I did not really believe Gardasil was causing this reaction until after the third shot! The SEVERE reaction she had after that third shot…….EVERYONE around her knew that Gardasil had caused this. She is not allergic to ANYTHING but herself. Because her body has made an autoantibody to HER. Her immune system is damaged by the Gardasil vaccine. I don’t know if HPV rDNA fragments bound to aluminum is causing all these injuries I dont know why Gardasil is causing injuries, but I am glad SOMEONE is trying to figure out why this vaccine is ruining so many lives! Gardasil has devistated our home and I will never stop tellling people how dangerous this vaccine is!

The same here. The HPV16W12E strain he cites is one that grows in tissue culture (Virology 262, 344-354 (1999)). Maybe he has those growing in his lab, so he had the accession number handy?

Thanks for geeking out with me.

It’s not showing up in the top BLAST results, but local alignment of the 184 nucleotides against accession #AF125673 does indeed produce a perfect match.

Again, I understand the skepticism, but let’s focus on the big flaw here: the origins of these sequences.

That’s not being ignored but the methods and results are just rather inconsistent with standard reporting and even internally. I’m always rather curious why an investigator would opt for such silliness as publishing electropherograms instead of a GenBank accession number, foregoing better techniques and making such a big deal out of the pre-mixes used.

“Did I mention they tested her for Heavy Metal Poisioning, she was what the doctors called “TOXIC” with aluminum”

It would be major news if someone who received a vaccine containing aluminum adjuvant tested “TOXIC” for aluminum on heavy metal screening. Can we see the report or other documentation of this?

I am tired of this, as is my mother. 1. Gardasil was fast-tracked, only proved to last five years in females and 2.5 in males. (Fact. Google it.) That doesn’t make Gardasil bad, it
s just a fact that the CDC for some reason did not want to share this. So we are. To everyone. Including those who are hard-headed.

Um no Mickayla, that is not a fact. What is a fact that was shown to your mother was that Gardasil has been demonstrated to provide protection for a minimum of 8 years and that is only a limitation of the study period. The links are upthread; try reading before spouting off.

2. You were warned. The point of telling people this was not to argue it, but to inform people who have had reactions that they are not alone. When I had a reaction to this, no one believed it. (Well besides the community, no doctors thought so) because they didn’t even know what the shot did. On the Gardasil website they say (look this up) Urticaria can be caused by Gardasil, it is a symptom of this shot, it can show up even many months after. Don’t believe it? Go to the website and look at it. It didn’t take me six years of med school to figure this out.

Yet here you are arguing and pimping your story to SANEVAX. You and your mother can’t even explain to us how Gardasil is responsible for shingles one month post vaccination and hives nearly one month post vaccination. Your story makes no sense which is why ignorant people believe your emotional outbursts but physicians and scientists do not. Hives are an immediate reaction, not weeks out. Apparently you should at least finish high school before arrogantly ignorantly proclaiming you don’t need higher education to understand some physiology.

You may be a scientist but apparently you’ve lost your common sense. Three strikes your out. I had three immune reactions to three doses of Gardasil.

On the contrary, it is you and your mother who have no common sense as evidenced by your insistence that Gardasil caused your shingles and hives weeks out. I’m sorry for what you are dealing with and I’m even sorrier that you have decided to ignore the evidence and are driven by anger at a perceived enemy.

@Jess

Skin reactions can take a long, long time to clear. I had the misfortune of getting exposed to poison ivy. It took several days for the rash to start appearing. Over the course of a couple days, the rash got much worse, with more hives appearing as the days went on. My skin did not begin clearing for over a week, and then took several weeks before the last remnants were gone.

Now, I knew exactly what the cause of my reaction was (I had just run the Run for Your Lives Zombie 5K and remembered that I went off the trail and into the undergrowth several times, not to mention the reaction was limited to the portions of my legs that had been exposed). I just want to illustrate that contact dermatitis can start slowly, build, and then take a very long time to go away. The entire time, from shortly before the hives appeared until they were gone, it took a great deal of effort not to scratch. There was nothing I could do to stop it, since I had already long since washed off the urushiol; I just had to wait for my body to finish dealing with the reaction. No lotion, change of detergent or anything else would have made it go away.

Mickayla,

I am tired of this, as is my mother.

I don’t believe anyone asked either of you to come here and start posting misinformation about Gardasil.

1. Gardasil was fast-tracked, only proved to last five years in females and 2.5 in males. (Fact. Google it.)

Not a fact, it lasts at least 8 years, and we have every reason to believe it lasts for much longer than that.

The point of telling people this was not to argue it, but to inform people who have had reactions that they are not alone. When I had a reaction to this, no one believed it.

I’m not surprised no one believed it because what your mother has described bears no resemblance to any vaccine reaction, and certainly not to any reactions that have been observed after Gardasil. As others have pointed out, vaccine reactions do not occur weeks after vaccination, it simply isn’t possible.

On the Gardasil website they say (look this up) Urticaria can be caused by Gardasil, it is a symptom of this shot, it can show up even many months after. Don’t believe it? Go to the website and look at it. It didn’t take me six years of med school to figure this out.

Urticaria is an allergic reaction that occurs hours after exposure to an allergen, not weeks later. Perhaps you didn’t notice that the package insert that mentions urticaria says:

Because these experiences were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.

In other words, just because people report a symptom doesn’t mean it was caused by the vaccine.

You may be a scientist but apparently you’ve lost your common sense. Three strikes your out. I had three immune reactions to three doses of Gardasil.

No you haven’t. Immune reactions don’t wait for weeks before they occur. It is almost certain that your “immune reactions” would have happened even if you hadn’t been vaccinated with Gardasil. It is far more likely it was something you ate or drank, or were otherwise exposed to in your environment that caused your symptoms.

She feels guilty because she made me get the shot. Her best friend is dying of cervical cancer, and she didn’t want the same to happen to me.

She shouldn’t feel guilty, as there is no reason at all to believe that your problems are anything to do with Gardasil. Unfortunately there is a very vocal lunatic fringe who believe that Gardasil is responsible for sickness and death in large numbers of people, but they are wrong.

Now, sit here and say I’m talking crazy, I’m too young to understand what’s been happening to my body for a whole year, that I don’t know what I’m talking about because I’m not a professional. I obviously don’t care.

No one is suggesting that you haven’t been unwell, but whatever has caused your problems, it wasn’t Gardasil.

Go to Gardasil.com and look at the reactions list if you think you may have had a reaction. Also, don’t worry if it’s a month to two months after, Gardasil also says to look at these symptoms even if it has been months after, to tell your doctor as well, to not get another dose if you have had any other reactions.

Hundreds of thousands of people have been monitored after being given Gardasil and none of these problems have been seen more frequently than in people who haven’t been given the vaccine.

It is not worth getting the shot if you become injured for life.

No one has been injured for life by Gardasil, but over 3,000 women die of cervical cancer every year in the US. I am concerned that you are putting people’s lives at risk by spreading inaccurate information about Gardasil.

Not finding any mention of gardasil causing urticaria many months after immunization on the gardasil.com website…

JGC,

Not finding any mention of gardasil causing urticaria many months after immunization on the gardasil.com website…

The only mention of urticaria I could find on the whole site was in the Merck package insert, with the proviso I quoted above.

What do you guys expect from Mikayla…when her mother keeps beating the drum about Gardasil and its “association” with the onset of shingles and urticaria.

Here’s the latest *gem* from Jess…

“All 3 immunologists that examied her did not state Gardasil was NOT the cause, the FDA did not deny Gardasil could be the cause, nor did her doctor nor did the rhumatologist. They could not rule it out. Neither can you.”

(Interpretation)

I’m using mangled English with double negatives now to *prove* that I am right.

From Jess’ Facebook page…listed under “interests”.

Truth About Gardasil, Vaccination Information Network (VINE), Truth About Gardasil,Oscarthecat, One More Girl, Lawrence B. Palevsky, M.D., International Medical Council on Vaccination, vactruth.com, NVIC, Immunitrition, International Vaccine Injury Awareness, National Vaccine Information Center, SANEVAX, Seriously Concerned About Gardasil (Cervical Cancer Vaccine), Gardasil Victims Action Alliance, The Dangers of Gardasil (HPV/Cervical Cancer Vaccine), ONE MORE GIRL – Documentary, Nations Vaccine Claim Center, Academic Integrity Fund, Vaccine Injury Treatment: From Autism to Gardasil Syndrome, Gardasil kills.

Seriously Jess,

– Enroll in some basic science courses
– Stop endangering your patients…get a seasonal flu vaccine
– Stop filling up your daughter’s brain with nonsense
– Get a life

I would add to lilady’s comment, Jess, that you avoid dishonest and lying organizations like NVIC, vactruth.com and so forth. These places have a habit of, at best, distorting science and truth and, at worst, outright lying.

“Did I mention they tested her for Heavy Metal Poisioning, she was what the doctors called “TOXIC” with aluminum”

It would be major news if someone who received a vaccine containing aluminum adjuvant tested “TOXIC” for aluminum on heavy metal screening. Can we see the report or other documentation of this?

It wouldn’t be that unusual at all, depending on the ordering physician and which lab they used.

@Mickayla and Jess, would you describe to us the method of testing for heavy metals and which lab was used to process the results?

As for everyone else, state your opinion as it is a free-country, but realize karma will always come back to bite you.

I take it that you don’t see the irony in this statement.

I’d like to know how aluminium got on a “heavy metal screening”.

Somehow I get the feeling that Jess isn’t going to actually show us any of the documentation nor share her NVICP transcript.

@Jess and Mickayla, With all sincerity, please do share the method of testing for the heavy metals. If you absolutely must, then leave out the name of the lab, but I would seriously like to know the method of testing. It should pose no problem to name the lab, as they are most certainly a commercial entity and advertise their services elsewhere.

She had 60 skin tests!

I noted that this assertion is also made in the VAERS report (471601). Having had skin-prick tests for allergies in the past, I’m kind of wondering what the game is here. Do you mean one test with 60 allergens? Two?

According to the VAERS link that Narad provided and that Jess filled, her daughter has a history of eczema. There is a notation that mom has all the blood tests and they are WNL.

Jess also ranted that her daughter has “dermographism” AND “urticaria”

How about this Medscape article about Dermographism Urticaria?

http://emedicine.medscape.com/article/1050294-overview

“The term dermographism (or dermatographism) literally means writing on the skin. Firm stroking of the skin produces an initial red line (capillary dilatation), followed by an axon-reflex flare with broadening erythema (arteriolar dilatation) and the formation of a linear wheal (transudation of fluid/edema); these events are collectively termed the triple response of Lewis.

An exaggerated response to this constitutional whealing tendency is seen in approximately 2-5% of the population and is referred to as dermographism. In a minority of people, it is accompanied by itching (symptomatic dermographism)….”

Jess needs to get soothing emollient lotions for her daughter and effective antihistamines. She also need to tell her daughter to stop scratching herself which causes her urticaria rash.

And Jess, if Mickayla is deliberately scratching herself to raise up wheals and urticaria, you have only yourself to blame because of your fixation on Gardasil as the trigger.

Also don’t send Mickayla here to post…I would hate to go after a snotty know-it-all kid.

A history of eczema.

A child going through puberty.

Of course, Jess is also sure Mickayla has not tried any new substances, is exposed to any new substances, is in environments where she could come into contacts with new substances, is around people that might shed or wear anything she is allergic to, et cetera.

In other words, she is magical and unlike any other teen on the planet. Also, her eczema has nothing to do with any allergic outbreak, but Gardasil gave her shingles.

Did I get this right so far?

@ lilady;

about going after youngsters:
I would hesitate if the said youngster were under the age of 18 ( see Natalie Palumbo @ AoA).
Or you can use kid gloves.

The only clinical test for aluminum Doctor’s Data is offering (according to a search of their website) is hair analysis, which is considered notoriously inaccurate by professionals in the field of metal toxicity.

Great Plains Laboratory (which is involved in “autism diagnosis) offers metal testing using hair, urine blood and stool.

Tests considered useful/reliable for aluminum toxicity include the deferoxamine infusion test and bone biopsy – analyses of hair and bodily fluids don’t fall into that category. It’s a multimillion dollar business for some U.S. labs, though.

How old is Mickayla?

Mickayla stated: I am tired of this, as is my mother… It didn’t take me six years of med school to figure this out.

@MI Dawn, then how is she posting that she and her mother are tired of this, and that she, Mickayla, had six years of med school?

Oh, I see. Mickayla meant that she figured out the cause of all of her medical problems without having to go through six years of med school. So med school to her is a waste of time and unnecessary. I’m going back to bed now with my bad cold.

Dear Jess and Mickayla,

Jess states “All 3 immunologists that examied her did not state Gardasil was NOT the cause, the FDA did not deny Gardasil could be the cause, nor did her doctor nor did the rhumatologist. They could not rule it out. Neither can you.”

Fine. Prove to me that the invisible pink unicorn standing on my ceiling doesn’t exist and then I will follow your method.

Jess,

Let’s say my daughter is given Gardasil. After the 3rd dose, she develops shingles. How much time do you believe needs to pass after receiving the 3rd dose for you to not think Gardasil was the cause?

I am tired of this, as is my mother.

You are tired of leaping to the defense of the SaneVax scam and arguing with anonymous strangers every time your spidey sense tells you that someone on the Internet is criticising SaneVax?

Stop doing it then.

I can’t resist, Jess’ method of determining what is right and true is too much fun to pass up… Jess, since you cannot prove that Mickayla’s symptoms are not caused by sparkly vampires from Stephnenie Meyer’s TWILIGHT story series I hereby conclude that Team Edward is the cause of her woes.

I shall maintain that this is true and the case is closed until you can conclusively prove otherwise.

The only clinical test for aluminum Doctor’s Data is offering (according to a search of their website) is hair analysis, which is considered notoriously inaccurate by professionals in the field of metal toxicity.

A test for aluminum is included on their provoked 6-hour Urine Toxic Metals test, which is typically performed after administration of a provoking agent such as DMSA or EDTA. http://www.doctorsdata.com/repository.asp?id=2605

Jess, Which tests were used to diagnose the aluminum toxicity?

DB, That was easy. I bet if I kept talking, I’d likely have you laughing so hard you’d break a few ribs. Maybe another time.

Mickayla,

it’s just a fact that the CDC for some reason did not want to share this.

Just a thought: invoking conspiracy theories generally makes your argument look bad. I doubt very much that the CDC withholds medical information about effects.

On the Gardasil website they say (look this up) Urticaria can be caused by Gardasil, it is a symptom of this shot, it can show up even many months after. Don’t believe it?

I suspect they say that urticaria has been reported to have occurred after vaccination. (This does not say that the vaccine caused the urticaria.)

Go to the website and look at it.

I can do a little better and look at the research literature. There are just five papers with “gardasil urticaria” – four, really, once you realise one is an informal summary of the others. [Bear in mind this searches abstracts, not the body content of the papers.]

These report reported reactions. These reactions occurred with an hour to ninety minutes after the injection, not a month or more later.

It will almost certainly be these reports that the Gardasil website is referring when it is noting that there are reports of urticaria having occurred after a Gardasil injection.

You claim you don’t need “six years of med school to figure this out”. You need to understand a thing before you can criticise it, however. In this case you need to understand how research is done and why it is done as it is.

Reported events give correlations with another event. The do not by themselves show that one event caused another.

Generalising, the longer the time between the initial event and it’s possible effects, the more frequently effects that have nothing to do with the initial event will be noted.

Make the time range too long and the study would be meaningless.

If you included possible effects from several months after the initial event, literally every single medical condition found in that age group would be listed as a possible effect. It would be completely meaningless.

There are groups on facebook for people who have been injured, even the government made a compensation program for people who have been injured (in the USA.)

There are researchers who put a good deal of effort into checking and testing if treatments have ill-effects. They may not have Facebook pages, but they do have many years training in their fields and work very hard.

The government admits that vaccines can injure people obviously because the program was created.

Wrong. Others can fill you in (I’m not from the USA) but that program was set up because of the nature of the legal system in the USA, that your country has this practice of suing people seemingly left, right and centre! (Seemingly, to someone reading media reports about the USA, not that the media ever gives a fair image of a country.)

My name, my religious practices, my everything is not your concern to pick at.

This may not matter in your particular case, but unfortunately unfortunately a few religious groups have taken stances against Gardasil for reasons that really start with their religious beliefs. With that in mind, people will ask.

“Also, don’t worry if it’s a month to two months after, Gardasil also says to look at these symptoms even if it has been months after, to tell your doctor as well, to not get another dose if you have had any other reactions.”

I don’t think you’re in a position to be offering medical advice I’m afraid.

In this case the advice would be bad. Reporting the symptoms to your doctor with an open mind as to what caused them is fair enough. Presuming that the symptoms ‘must’ be from the vaccine because they occurred within a month or so of the injection is wrong-headed (for similar reasons as I mentioned when I wrote about testing earlier).

@Grant

Others can fill you in (I’m not from the USA) but that program was set up because of the nature of the legal system in the USA

Indeed so. Back in the 1980s, there was a scare regarding the whole-cell pertussis vaccine (DTP). A number of reports were made of neurological problems following this vaccine (which later scientific evaluation found to be unrelated to the vaccine). At the time, however, the scare spurred on numerous lawsuits, including spurious ones that didn’t even have a tentative connection with the DTP. The result was that the legal system was horribly bogged down, delaying families who should be compensated from getting justice in a timely manner. At the same time, the high legal costs associated with defending these suits led many vaccine manufacturers to quit the business altogether, because vaccines just weren’t money-makers and weren’t worth the risk of these kinds of legal actions. With fewer manufacturers, there was a very real threat that vaccine shortages would skyrocket, leading to a comeback of communicable diseases.

Lawmakers, manufacturers, patient advocates and parents all sat down to figure out what to do. The result was the Vaccine Injury Compensation Program. Manufacturers would pay a fee for every dose of vaccine they made. Those fees would go into a pool. A special judicial system was created to govern petitions for compensation, as well as to administer the compensation funds. For parents and patients, this meant that they could receive justice in a much more timely manner, as well as having a much lower standard of scientific proof for expert witnesses and claims. Furthermore, known adverse effects were put on a table of injuries. A patient who suffered an injury on that list did not even need to prove that the vaccine caused it; it was just assumed that was the case and compensation was awarded. All reasonable legal fees associated with the petition would be covered by the program at no cost to the petitioners, as well. And, any petitioner who was unhappy with the findings of the Vaccine Court could then opt to reject the judgment and sue in the regular tort system.

Science Mom: “Thanks for geeking out with me.”
No problem. I got my master’s degree in a lab that studied the ubiquitination degradation system in HPV16-infected cells.

Todd: you allege to it, but just to emphasize: this court does not operate on “proven beyond a reasonable doubt”, it operates on “50% + a feather”. It is much, much easier to get your way in the VICP than in a regular court. Or, to put it another way: if you can’t get your blood money (sorry, yes, that is a callous way of putting it, but when you blame vaccines for killing your child when it obviously had a rare genetic condition, that is EXACTLY what it is) in VICP proceedings, you really don’t have a case.

@Stu

Well, from my understanding, the “50%+ a feather” level of proof is standard for all non-criminal court cases. What’s different in the Vaccine Court is that as far as the scientific evidence presented (along with expert witnesses), the Daubert standard does not apply. But, IANAL, so any lawyers, feel free to correct me.

just to emphasize: this court does not operate on “proven beyond a reasonable doubt”, it operates on “50% + a feather”. It is much, much easier to get your way in the VICP than in a regular court.

Preponderance of the evidence is the normal standard in a civil action. NVICP claims differ in having a presumption of causation for table injuries and looser procedural and evidentiary rules for non-table injuries. It is indeed much easier than a true adversary proceeding, but not quite for the reason of the standard itself.

I guess I’m stoopid because I didn’t go to medical school for six years.

It was a four-year program. They probably left out the stuff about toxins, vaccines being eevil and oh yes, all the nutrition science the alties know about but physicians don’t.

In other vaccination news, that fabulous book that encourages children to get sick with measles (“Melanie’s Marvellous Measles”) has been pulled from an online bookstore after protests in Australia. All the complainers probably were pharma shills. 🙁

ht_p://www.news.com.au/lifestyle/health-fitness/controversial-anti-vaccination-book-removed-from-sale/story-fneuzlbd-1226551911539

I suppose I can understand the first reaction. It must be hard to think that you’d put your child through so much pain, just because you bought a different brand of fabric softener or peanut butter. But not getting past that, and refusing to get the routine allergen screens to identify the cause, thereby causing your child more pain – that I don’t understand.

Mickayla wrote:

Gardasil was fast-tracked, only proved to last five years in females and 2.5 in males. (Fact. Google it.) That doesn’t make Gardasil bad, it’s just a fact that the CDC for some reason did not want to share this.

Well, others have already demonstrated that CURRENT evidence demonstrates that your claim of the duration of Gardasil-derived protection is false. So let me address the other part of your claim.

My daughter’s about your age, and she likely has no more idea than you do what it means when FDA grants “fast track” status to a vaccine or drug in development. Let me explain, starting with what “fast track” does NOT mean.

“Fast track” does NOT mean that any corners were cut, that thorough analysis was neglected, or that the compound didn’t receive the normal, extensive scrutiny that is required for other vaccines or drugs that did not receive that rare designation.

Instead, “fast track” status–which is rarely granted–allows an expedited review to a company whose drug or biologic makes both a product and a marketing claim that addresses an unmet medical need. That does NOT mean that the product or biologic is rigorously scrutinized than other compounds–the review process simply starts earlier.

Really, instead of waiting to submit the full package of study materials (that’s a huge amount of information: before the advent of electronic filing, applicants would back an eighteen-wheeler up to the FDA facility to unload all the paper), the fast track review process can begin BEFORE the final results become available months after the completion of the second large (and blinded) Phase 3 clinical trial. Thus the FDA can begin to review the chemical, biochemical, in vitro, and Phase 1 and Phase 2 human study data that were completed years earlier BEFORE the results are in from the final Phase 3 studies. Of course, all of that information–including the Phase 3 studies that are submitted some months later–is appropriately scrutinized.

The clearly implied argument that Gardasil was inadequately reviewed because of its fast track status is based either in ignorance or in dishonesty. If you choose to use that argument again, now that you are better able to understand FDA’s fast track process, it can only be for one reason.

BTW, your mom, as a nurse, wouldn’t be expected to understand the FDA fast track review process, so she’s not lying to you–she’s likely just read material written by people who are either dishonest or ignorant.

I know very little about dermatology, but could a shingles outbreak make eczema worse?

Dedicated Lurker – Some eczema sufferers get flare-ups when they’re under stress. I imagine that the combination of shingles, being a teenager, and a mother screaming about how the “EVIL HPV PUSHERS MERCK BIG PHARMA HURT MY BAYBEE” could be stressful.

If said mother did this for weeks after every shot, and was obsessing over every zit, scratch, and mark that appeared, then *boom* eczema flare.

Also, the VZV that causes shingles also takes advantage of weakened immune systems. So if someone was stressed enough to have an eczema flare, then VZV could be riding eczema’s scaly coat-tails into Dermisville.

It actually makes me wonder if mommy dearest was freaking out from day one, the initial shot. IMHO it’s pretty abusive to constantly howl at your young child that their life is ruined, that they’re terribly ill with a disabling neurologicat condition, that they’ll never fulfill their potential, and that many young people died because of that same vaccination. Raving about how every doctor is conspiring to deny it, that the government, pharmaceutical companies, schools, researchers and scientists everywhere are plotting and scheming to kill innocent children with evil toxin cocktails, because it makes. them rich, and that anyone who denies this is a paid shill.

I can only imagine how terribly upsetting and stressful that would be. Hives? Kid’s lucky she hasn’t had a breakdown.

Some eczema sufferers get flare-ups when they’re under stress.

When I’m under stress, I get eczema. When I’m under stress, I also tend to eat more comfort foods, especially those containing milk and fruit derivatives, such as a hamburger with ketchup or cheese, pizza, chocolate, or toast with added jelly or butter, and I get eczema. They are delayed allergies and I spent years going from doctor to doctor for help in treating the eczema, and I had many allergy tests. Skin tests would not evoke a positive until one to two days after the test, long after I left the doctor’s office. I’d call them and ask to come back in, only to have an appointment scheduled for the following month, their next available appointment. They would assure me over the phone that I had showed no reaction with the tests, and my “new” symptoms were undoubtedly caused by something else. The skin reactions would be gone by the time of that next appointment.

More tests and repeat allergy tests always resulted in the same very delayed response. So I decided to just show up at the doctors office two days after the test in hopes of at least letting the nurse or receptionist see my skin reactions. That worked. Both the nurse and the doctor finally saw the reactions, a perfect line-up of red, itchy bumps across my arms in the same exact pattern as the skin tests they had done days earlier. Of course, I didn’t react to every single allergen, but enough to prove my point, or at least that is what I thought. They told me it was impossible to show a reaction days after the fact. They told me that I was scratching myself in the same places to make it look like the test, and that I needed counseling. Yet, when I’m not under stress, and I eat those same foods, I get eczema.

Is eczema really flared by the stress, or other factors that coincide with the the stressful situation? Years later, I finally did get a leading immunologist to agree to see me several times over the course of two weeks following the skin tests and document the reactions. The validation that the skin responses were indeed delayed responses to the test, and that I was not intentionally injuring myself for the attention was substantial.

I posted up thread and provided this link about the symptoms that Jess’ daughter is experiencing as contained in the VAERS report…and as contained in her rants that she posted on RI. IMO, Jess has filled her daughter with nonsense by telling her she is “vaccine injured”. Her child may be deliberately evoking symptoms to gain her mother’s attention. I hope they haven’t already spent the money that they think they will collect from the Vaccine Court…because they will never be able to prove that Gardasil vaccine is “what done did it”.

http://emedicine.medscape.com/article/1050294-overview

Most of the nurses that I *know* are aware that shingles is a reactivation of a prior chicken pox infection, heh, heh.

Most of the nurses that I *know* have the ability to do research on the internet and the ability to understand dermatological conditions, heh, heh.

You people are way creepier than I ever thought- ‘skeptics,’ ‘skepchicks’, ‘Science blogs’ . One of your own ‘skeptics’ has sent someone (Ms Dorey, AVN) violent pornographic images and left threatening messages (die in a fire and just burn) all traced to the ‘skeptics’ home in Australia. You guys are CREEEEEEPY. I’m out for good here. Bye creeps.

“I’m out for good here”

Promise to really stick the flounce Jen?

Who’s got the screen shot from AoA depicting scientists at a Thanksgiving table feasting on a baby?

Ta-ta creepy Jen.

@ Jen,

Generalisation of the behavior of one person over an entire group. If we apply the same reasoning, you all advocate for chemical castration of autistics? How creepy of your group too.

Alain

Thanks Todd W.

AdamG…only a fool would make that wager. 🙂

She’s been cyber stalking me at the Ho-Po..posting under “jened”.

One of your own ‘skeptics’ has sent someone (Ms Dorey, AVN) violent pornographic images and left threatening messages (die in a fire and just burn) all traced to the ‘skeptics’ home in Australia.

You mean this, Jen, or has Meryl’s delicate disease fetishism been offended once again?

Sadly, the AVN’s fortunes seem to be declining. An Australian governmental agency has ruled that the AVN must change its name to stop deceiving the public as to its true agenda:

“The AVN now has until February 21, 2013 to submit an application for a name change which also must be approved by the Commissioner. Of course, Dorey and co have a right to appeal this order, but if they decide to ignore it, their registration can be cancelled and their assets seized and split up – making this a rather serious matter indeed.”

“So far, Dorey has responded to the order in the only way she knows, with accusations of “suppression of free speech” and “government bully boys”. And in a bizarre analogy she questioned why she was being targeted when “Greenpeace is not green, nor do they go around looking for peace…”.”

ht_p://theconversation.edu.au/anti-vaccination-network-told-to-change-its-name-or-be-shut-down-11368
ht_p://www.heraldsun.com.au/news/victoria/minister-orders-anti-vaccination-group-to-change-its-name/story-e6frf7kx-1226537155195

If you do a Google search for Australian Vaccination Network, eight of the first ten links are to sites not favorable the the AVN’s antivax mission (including two that superficially appear to be official AVN sites, one of which is an online drug seller and the other of which is anti-AVN (did someone at the AVN forget to renew rights to a web address?).

We should have a contest to help Meryl et al rename her organization. “Anti-Vaccination Network” is the obvious choice, but more inventive and descriptive ones (like Moms for Marvellous Measles) should be in the mix too.

The fact that AVN also stands for ‘Adult Video News’ is likely responsible for some of the pornography that has been associated with AVN, rather than a sinister attack by skeptics.

Meryl Dorey has stepped down from the AVIN to devote her time to “special projects.”

ubiquitination degradation

We’re here! We’re everywhere! We’re the UbiquitiNation!

So let’s just review the facts for a moment: The scientist who has basically written the book on high sensitivity PCR testing and published many peer reviewed papers (several on HPV DNA sequencing) has got it all wrong. I guess the FDA got it wrong too since they agree that the vaccine is contaminated with HPV L1 gene DNA fragments.

It’s funny reading all these amateur complaints here about the peer reviewed published science. I’ll note the glaring absense of any criticisms posted to the actual journal of publication which our “expert” here knows full well is the way real scientists openly debate points on peer reviewed science.

Is our oracular “expert” honestly interested in what the HPV DNA fragments (that the FDA admits are there) can do in the human body? I think not. If he was, the article clearly notes that samples were stored for further research at the Auckland Hospital for independent investigation. I mean, if he’s so concerned about the proper science, I’m sure the coronal court would send him the split samples and he could use the published methods to validate the results. But of course, Merck wouldn’t pay him for that would they? Better to make money off groupies clicking ads on a fully moderated soap box. Hey, I’ll admit, the soap box looks like way more fun.

And I really have to laugh at the groupie discussion about forcing HCWs to wear masks if they work sans flu vaccine. I mean seriously, a bunch of people claiming the side of science mandating an intervention of masks when the evidence clearly points to lack of any sort of efficacy on that front. Of course, why should I be surprised? It’s not like the flu vaccine has any demonstrated efficacy either. I mean if we were using actual evidence from flu trials, every HCW should be wearing a mask. That would save a lot of money if you all really insist on an intervention, even if it won’t prevent any cases of the flu.

@Mr Pink:

So let’s just review the facts for a moment:

You have an interesting definition of facts.

The scientist who has basically written the book on high sensitivity PCR testing and published many peer reviewed papers (several on HPV DNA sequencing)

Please provide links to those peer reviewed papers

has got it all wrong.

Yes. He had no controls. For all we know, he could have detected something else. Negative controls check against this.

I guess the FDA got it wrong too since they agree that the vaccine is contaminated with HPV L1 gene DNA fragments.

Citation please, and from reputable sources, not antivaccination websites.

But of course, Merck wouldn’t pay him for that would they?

Pharma Shill Gambit.

Better to make money off groupies clicking ads on a fully moderated soap box.

Irony and Hypocrisy Meters vapourised. Antivaccination websites are heavily moderated while your comment was posted here.

a bunch of people claiming the side of science mandating an intervention of masks when the evidence clearly points to lack of any sort of efficacy on that front.

65% > 0%. Learn some basic maths.

It’s not like the flu vaccine has any demonstrated efficacy either.

I’d like proof of this claim, and again, not from an antivaccination website.

The scientist who has basically written the book on high sensitivity PCR testing

Which book would this be, pray tell?

It’s funny reading all these amateur complaints here about the peer reviewed published science.

See, this is the part where you get to demonstrate your not being an “amateur,” Quincy.

But of course, Merck wouldn’t pay him for that would they?

Mr Pink has “struck the wooden skewer on its thicker end”, as Kai Lung puts it . Dr Lee was the one who tried to shake down the FDA to institute a universal HPV testing regime — licensing his test — replacing the HPV vaccines. The authorities said No, because he had no evidence for the validity of his tests. That was the stage where he set out to discredit the HPV vaccines, in popular opinion at least since his attempts to recruit the scientific community attracted nothing but laughter.

This is all well-documented, with various court documents readily available.

I’m sure the coronal court would send him the split samples

‘Coronal’ is a suture in the skull. NZ coroner’s courts are not so sanguine about sending out human body samples as Mr Pink appears to believe.

‘Coronal’ is a suture in the skull. NZ coroner’s courts are not so sanguine about sending out human body samples as Mr Pink appears to believe.

Something something 18 heads at O’Hare airport something.

Which book would this be, pray tell?

http://www.springer.com/series/7651

Chapter: Lee SH. Guidelines for the use of molecular tests for the detection and genotyping of human papilloma virus from clinical specimens. Methods in Molecular Biology, volume Diagnosis of Sexually Transmitted Diseases. C. MacKenzie and B. Henrich, Volume Eds. J. Walker, Series Ed. Humana Press.

See, you and Orac could educate yourselves.

This is all well-documented, with various court documents readily available.
In the banal words of Julian Frost above, “Citation please, and from reputable sources”, not advert-funded soap boxes. Frankly, I think it unlikely that any court document discusses any shakedown, validity of Lee’s tests, or the laughter of groupies on a soap-box side show.

NZ coroner’s courts are not so sanguine about sending out human body samples as Mr Pink appears to believe.
Yet, Shaw and Lee got a hold of them and did some extensive testing. One would think that according to you guys, the “real” scientists would have no trouble clearing things up for them. I sense the cognitive dissonance from here lol.

@Mr Pink:

Chapter: Lee SH. Guidelines for the use of molecular tests for the detection and genotyping of human papilloma virus from clinical specimens.

Your link goes to a bookstore that lists the book under “New and Forthcoming titles”. When we asked for citations, we want to see links that show that Sin Hang Lee’s work was peer-reviewed by people who know the field. You haven’t. All you’ve done is basically advertising.

“Citation please, and from reputable sources”,

I am wondering about the utility of providing citations to someone who has just shown himself unaware of the difference between “the book” and “a chapter”.

Julian:

“Please provide links to those peer reviewed papers”

‘Dr Pink’ is welcome to provide the citation index counts for Dr. Lee’s work compared to those working in the PCR methods field. I doubt Dr. Lee’s work rates particularly well compared to the better people in the field.

Dr Pink:

“Which book would this be, pray tell?”

That’s not a book, that’s a chapter. Hell, I’ve written a chapter in a Springer book. (And contributed to another.) A book chapter doesn’t make the guy some super expert above all others. If anything, book chapters are soft publications.

“Yet, Shaw and Lee got a hold of them”

No, Shaw and Lee did not “get a hold of” the samples. The parents pushed for these two to be used. Quite probably, in turn, because anti-vaccine proponents pushed the parents to use them.

“and did some extensive testing”

Lee and Shaw did some (very) limited, narrow testing. The coroners in NZ did extensive and broad testing. (You don’t seem to have the faintest idea of what you’re talking about.)

(Lee in particular has links to an anti-vaccine group, SaneVax, which raises a few questions.)

Mr Pink’s problem is this: He is trying to convince random visitors to this comment thread that Dr Sin Hang Lee is the world’s leading authority on high-sensitivity PCR testing, the author of the accepted texts on the topic…

…When right at the top of the thread, readers can see right in the original post that Lee is reduced to publishing in an absolute bottom-of-the-barrel website — a ‘predatory open-access’ vanity-publishing scam that will put absolutely anything in their archives in exchange for the right amount of hard currency.

Please continue!

@grant, BTW, I’m not a doctor. For someone getting all literal about common metaphors that’s a pretty funny mistake no? But bravo on being the only one here who seems to be able to run a pubmed search for themselves. Why don’t you publish a link to the chapter you wrote? I would love to see the citation. Maybe I’ll even read it.

@grant, “No, Shaw and Lee did not “get a hold of” the samples.”
Really? They got the samples. That meets the criteria of “getting a hold of”. Did you request some samples and have problems with the court? Would the local authorities fighting the findings not welcome a request to have a self proclaimed expert on PCR do some more testing to help clear the air? This sounds like a lot excuses to me. The original point — which apparently was lost on you — is that our host here is an expert at feigning concern. In reality, it’s a lot of whining backed up by nothing but hot air.

@grant, “Quite probably in turn because anti-vaccine proponents pushed the parents to use them”
Quite probably? You don’t think it had something to do with getting the right experts to find the cause of death? Let’s see, a child dies after having a serious reaction to an HPV vaccine. You imply that in order to help determine the cause of death, they should have instead contacted a breast cancer surgeon (who writes a soap box blog as a side job attacking all manners of scientists) to do the investigation. Contacting the current experts who have recent published peer-review science on the two areas relating to the main ingredients of the vaccine was a mistake? (Specific strain HPV DNA and Aluminum) Good thing they were actually coerced by special interests into hiring the actual experts instead of listening to independent advice such as that posted here no?

Let me guess, next you’ll imply that if those parents were really wanting an expert opinion on vaccine damage, they should have contacted a vaccine expert like Thorsen instead right? For the right amount of money, they might have gotten far more studies in their favour from him no?

@bimler “I am wondering about the utility of providing citations to someone who has just shown himself unaware of the difference between “the book” and “a chapter”.”

I see you’re pedalling furiously, the wrong direction, and apparently, you can’t recognize a common metaphor. Do you take religious text literally too?

@bimler “He is trying to convince random visitors to this comment thread that Dr. Sin Hang Lee…”

More invalid assumptions. Seriously, the omniscient bimler apparently can read the minds of posters and scientists alike to accurately determine their motives. And the essense of truth is somehow infused in your head despite a gaping lack of evidence? Perhaps you actually believe an oracle is a real thing LOL. Seriously, it’s far more likely I’m just here to entertain myself at your expense than convince random readers who are unlikely to go to the bottom of the comments. Think about it smart guy.

@bimler, As for “publishing scam”, that reveals depths of ignorance. Are you an elitist fundamentalist now? Most journals (do you actually read any?) are putting things into their archives for currency. The difference between open access is that the actual content is less determined by currency. You pay, you get peer reviewed, you get published. In closed journals, you pay, you get peer reviewed and you get published… except that you might not get published, if they don’t think the article will generate enough money on the side, or they don’t like you because they stand to lose money from sponsors who don’t like the results, or because the article doesn’t help promote sales for another product of the parent company, or for whatever reason they decide. So who is really running the “scam”?

@grant, BTW, I’m not a doctor. For someone getting all literal about common metaphors that’s a pretty funny mistake no? But bravo on being the only one here who seems to be able to run a pubmed search for themselves. Why don’t you publish a link to the chapter you wrote? I would love to see the citation. Maybe I’ll even read it.

@grant, “No, Shaw and Lee did not “get a hold of” the samples.”
Really? They got the samples. That meets the criteria of “getting a hold of”. Did you request some samples and have problems with the court? Would the local authorities fighting the findings not welcome a request to have a self proclaimed expert on PCR do some more testing to help clear the air? This sounds like a lot excuses to me. The original point — which apparently was lost on you — is that our host here is an expert at feigning concern. In reality, it’s a lot of whining backed up by nothing but hot air.

@grant, “Quite probably in turn because anti-vaccine proponents pushed the parents to use them”
Quite probably? You don’t think it had something to do with getting the right experts to find the cause of death? Let’s see, a child dies after having a serious reaction to an HPV vaccine. You imply that in order to help determine the cause of death, they should have instead contacted a breast cancer surgeon (who writes a soap box blog as a side job attacking all manners of scientists) to do the investigation. Contacting the current experts who have recent published peer-review science on the two areas relating to the main ingredients of the vaccine was a mistake? (Specific strain HPV DNA and Aluminum) Good thing they were actually coerced by special interests into hiring the actual experts instead of listening to independent advice such as that posted here no?

Let me guess, next you’ll imply that if those parents were really wanting an expert opinion on vaccine damage, they should have contacted a vaccine expert like Thorsen instead right? For the right amount of money, they might have gotten far more studies in their favour from him no?

@Mr Pink/Mr Black/Whatever character from Reservoir Dogs:

Link to FDA documented admission that the HPV DNA is in the vaccine as Dr. Lee asserted.

Dr Lee was asserting that the fragments caused the problem. From your quote…

The presence of DNA fragments is expected in Gardasil and not evidence of contamination. Based on the scientific information available to FDA, Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks.

Not the smoking gun you seem to think it was.

The difference between open access is that the actual content is less determined by currency.

Thanks for the gratuitous demonstration that you have no understanding whatever of academic publishing.

You pay, you get peer reviewed, you get published.

Including how predatory OA works.

In closed journals, you pay, you get peer reviewed and you get published…

And when page charges occur, and that not all journals employ them.

except that you might not get published, if they don’t think the article will generate enough money on the side, or they don’t like you because they stand to lose money from sponsors who don’t like the results, or because the article doesn’t help promote sales for another product of the parent company, or for whatever reason they decide.

And how an editorial office works. And who the actual “sponsors” of academic journals are. And how the “products” of the “parent company” are sold.

Bravo.

Contacting the current experts who have recent published peer-review science on the two areas relating to the main ingredients of the vaccine was a mistake? (Specific strain HPV DNA and Aluminum)

Shaw’s lone claim to “published peer-review [sic] science” is two incidents of shooting up mice with aluminum hydroxide and/or squalene while mumbling about Gulf War illness and failing to note that this connection has already been looked at six ways to Sunday by people without colanders on their heads and found lacking, which is why AVA is still mandatory for combat deployments.

Narad,

Every single thing this sockpuppet says shows he,

– thinks snarky trolling is being clever

– has he knows little about the case at hand

– has damn-all understanding of how science and scientific publishing works

I’m not sure it’s even worth deconstructing his string of errors, even for laughs.

What might be more interesting is to know why he’s bothering with this act. Is he a SaneVax devotee (or employee), for example.

Yah, but attempting to deliver a stupid lecture on publishing to people who actually publish or, you know, just might happen to happen to have substantial experience in the business is like showing up naked on Gordon Liddy’s doorstep in the middle of the night with a head full of acid and claiming to be an avenging penguin.

– thinks snarky trolling is being clever

I hope this is not a criticism of snarky trolling.

the publisher SCIRP is on the list of so-called “predatory publishers” that the librarian Jeffrey Beall compiled (http://scholarlyoa.com/). This means that this publisher is suspected to be the kind of company that doesn´t care for a proper peer review for the sake of the quick money. SCIRP even has its own Wikipedia entry which consists mainly of the negative headlines it made in the past.

Beall’s blog is a great resource, not least for lazy bloggers who are looking for worthy targets for ridicule.

like showing up naked on Gordon Liddy’s doorstep in the middle of the night with a head full of acid and claiming to be an avenging penguin

I’m glad that happens to other people too.

@hdb,

“I hope this is not a criticism of snarky trolling.”

Good point. I distinguish between merely being snarky and being clever. Any form of language in the right hands can be useful, but mere use of them in itself doesn’t make the writer clever.

“like showing up naked on Gordon Liddy’s doorstep in the middle of the night with a head full of acid and claiming to be an avenging penguin”

With or without body paint?

(Sorry. Terrible sense of humour.)

Contacting the current experts who have recent published peer-review science on the two areas relating to the main ingredients of the vaccine was a mistake?

I am not going to criticise Christopher Shaw’s work in visual physiology (that could lead to social awkwardness if I ever run into him at a conference). Nor do I criticise him for publishing outside his nominal area of expertise; because (a) what matters in science is the quality of work, not trade certificates; and (b) pot, kettle, black.
There is valid concern, however, that his paper with Tomljenovic was published in a special issue of J. Inorg. Biochem. — devoted to finding aluminium toxicity everywhere, edited by a tinfoil-hatted anti-aluminium obsessive, and bypassing normal peer review. Not to mention the problem that their follow-up paper could only be published in an OMICS journal, this being an egregious rip-off scam even by the standards of the predatory-open-access world.

I was just impressed by the phrase “current experts”. It creates the impression that “expertise” comes and goes, shifting hither and thither in the manner of Divine Grace, so that one needs special criteria to tell upon whom it is bestowed at any given time.
Almost as if the “current expert” is “the person currently saying what I want to hear”.

@lillady, Grant, ToddW
Really? You guys think that’s sockpuppeting? I mean, it didn’t even go like this:

Mr Black: that’s a great point Mr Pink, I mean these guys just don’t get it. They must all be pharma shills.
Mr Pink: Thanks Mr Black, I think you must be right.

In reality, it’s called WordPress not liking some urls at springer and me experimenting to see what was wrong or if it was being selectively moderated like the Orac likes to do on occasion.

To qualify for sockpuppeting, some sort of deception needs to be involved. Duh.

@grant: I see instead of addressing the garbage you put out at first, you pull the classic retreat: “you don’t know what you’re talking about so I’m not going to waste my time”.

Run, run away fast. I would love to see that chapter you wrote. Your argument there was kind of funny. I mean it almost seemed like you were implying that since you were able to publish a chapter in a text, it wasn’t that big a deal. Is that because the chapter you published wasn’t original work, or was it poor quality?

I mean seriously, I don’t see how you win that argument no matter the scenario.

In reality, it’s called WordPress not liking some urls at springer and me experimenting to see what was wrong or if it was being selectively moderated like the Orac likes to do on occasion.

Fail.

@bimler “I am not going to criticize Christopher Shaw’s work in visual physiology (that could lead to social awkwardness if I ever run into him at a conference).”

Really? But you’re willing to effectively character assassinate (bordering on libel) Dr. Lee because you won’t run into him? Good grief, how professional of you…

@bimler “…that his paper with Tomljenovic was published in a special issue…”
And yet, you criticize the method of publication and none of the science. Last time I checked, those journals published letters. Please point out the one from Bimler criticizing the science, because I must have missed it.

“I was just impressed by the phrase “current experts”.”
I suppose I figured most people here are defenders of the fictitious “consensus science” or “defenders of the mainstream” but I never thought anyone would be brash enough to suggest that expertise was permanent and lasting. Science, technology and understanding moves all the time, and an expert today, is hardly guaranteed to be one tomorrow.

@narad: “fail”
Yep, I never was able to post the link. I’m sure you’re disappointed.

Yep, I never was able to post the link. I’m sure you’re disappointed.

Perhaps you’d like to describe it in adequate detail that the “WordPress not liking some urls at springer” bit can be subjected to scrutiny.

Really? But you’re willing to effectively character assassinate (bordering on libel)

Oh, look, the pretend publishing expert is now emitting legal analysis.

It doesn’t matter a single bit if Lee is able to do a PCR correctly.

He fundamentally failed to provide evidence that the fragments he sequenced were of vaccine origin.

Why on Earth would such an expert at HPV detection choose to amplify and sequence the L1 gene itself rather than across the breakpoint of the gene and the vaccine-specific plasmid?

This is basic PCR design 101. He’s either being moronic or deceptive…take your pick. I’m going with deceptive, because he knew that with this large of a design flaw he stood no chance with peer review.

But you’re willing to effectively character assassinate

My character assassination is effective? At last I can join the Guild!

Shows how much a troll s/he is to try make out a sensible decision not to engage with nonsense is ‘a retreat’ (and illustrating how sensible that decision was by trying cheap smears of the other person) and studiously avoid a relevant point raised.

Ironic to write ‘But you’re willing to effectively character assassinate (bordering on libel)’ when the troll has done just that.

But then that’s trolls for you, too. Busy accusing others of what they do themselves.

I’m busy with local more important things anyway. (One being stiff about a NZ anti-vaccine group being raised in the media; see my location. And I’ve work and life things to attend to.)

Herr Doktor Bimmler

a tinfoil-hatted anti-aluminium obsessive

Ian’t that an oxymoron or can one still get tinfoil made from tin?

Please point out the one from Bimler criticizing the science, because I must have missed it.

Not seeing many publications in the field by Pink, either.

@narad — For the life of me I couldn’t get wordpress to accept the full springer url link to the textbook. It had dots, hyphens and a long path and I still don’t know what it didn’t like. I even tried removing those characters replacing them with words with parentheses. Never worked and I wasted enough time on it. It took several posts for me to narrow the problem down to the url, and the double post was one of few successful attempts.

@bimler “Not seeing many publications in the field by Pink, either.”
But then, I’m not whining unprofessionally about others’ papers either.

@grant “shows how much a troll …”
Grant, your continued potshots show how dishonest your arguments are. And if I’m really a troll then you’re doing the feeding and that kind of makes you the newbie or dupe doesn’t it? I don’t see how you’re going to win that argument either. That’s two lose/lose arguments in a row.

@grant “… when the troll has done just that.”
Apparently, the dupe thinks I’m a qualified assassin of caricatures posting anonymously on a soap box. I never realized a caricature could be libelled. Do tell.

@grant “I’m busy with local more important things anyway”
You’re repeating yourself. For one so engaged in this blog, frankly, I don’t believe you. I would still love for you to explain how your own publication of a textbook chapter lessens the value of Dr. Lee’s contributions, but I’m not holding my breath. Apparently, you realize that’s a losing argument.

For the life of me I couldn’t get wordpress to accept the full springer url link to the textbook. It had dots, hyphens and a long path and I still don’t know what it didn’t like.

Once again, you are invited to present it. Munge it or stick it into a link shortener and present the hash.

As I’ve mentioned above, Mr Pink’s taking us on a complete tour of distractions. The real problem, as ze so conveniently ignores, is that Lee fundamentally failed to provide evidence that the fragments he sequenced were of vaccine origin.

the value of Dr. Lee’s contributions

By the way, someone should really let the scientific field know about all these ‘contributions,’ His chapter you’ve listed above has exactly 0 citations. Kinda weird for someone you claim ‘wrote the book’ on HPV detection. Does it count to write a book if literally nobody has read it?

@AdamG: “His chapter you’ve listed above has exactly 0 citations.”
You might also note that the textbook was very recently published, so I’m not sure how you would expect citations already, unless people regularly pump out research from start to publication in a really short period of time. I also doubt that Springer would publish a text book that no one was going to read going forward. But then, this argument is really a side show as you noted.

@AdamG: “Mr Pink’s taking us on a complete tour of distractions.”
The path of the discussion was laid by the responses to my post.

@AdamG: “Why on Earth would such an expert at HPV detection choose to amplify and sequence the L1 gene itself rather than across the breakpoint of the gene and the vaccine-specific plasmid?”

If you read the FDA link I provided, you’ll note that they said quite clearly: “presence of human papillomavirus (HPV) DNA fragments in Gardasil”. The FDA did not say that the entire plasmid with the breakpoint of the gene and the vaccine-specific plasmid is present. Remember, these fragments are contaminants and are present in small quantities despite attempts to remove them in the manufacturing and purification process. The manufacturing and purification process themselves may have broken the DNA down to fragments, and then they are bound to the aluminum salts which is added to the vaccine as an adjuvant.

@AdamG: “He fundamentally failed to provide evidence that the fragments he sequenced were of vaccine origin.”

Taken from the Abstract: “The HPV-16 gene DNA detected in the postmortem materials was similar to the HPV-16 gene DNA fragments in Gardasil in that both were in non-B-conformation”. From the discussion: “Similar topological non-B conformational changes in HPV L1 gene DNA fragments bound to the AAHS particles in the Gardasil vaccine have been demonstrated by a low temperature (LoTemp) PCR catalyzed by a highly processive DNA polymerase with proof-reading function [26]. Aluminum, unlike other metals, is known to stabilize and destabilize portions of a dsDNA molecule at different pHs, cause intrastrand cross-links, and create a “non-cooperative melting profile” for the bound DNA molecule [27].”

The key to all this is understanding conformations of double-stranded DNA, especially when bound to aluminum salts. This is all about developing a PCR method to detect DNA fragments in various conformations. Of course Orac casually dismissed all the complexity as handwaving.

I also doubt that Springer would publish a text book that no one was going to read going forward.

That’s not a textbook, and you apparently don’t understand what the Humana imprint is for. And I’m still waiting for the actual cursed URL.

@Mr Pink:

“The HPV-16 gene DNA detected in the postmortem materials was similar to the HPV-16 gene DNA fragments in Gardasil in that both were in non-B-conformation”.

Dr Sin Hang Lee used multiple amplifications. That raises questions about what he detected. He also had no negative controls.
What he was recording could be almost anything.

You might also note that the textbook was very recently published, so I’m not sure how you would expect citations already

In addition to the zero citations his textbook chapter has, none of the papers Lee lists on his own website have any citations other than Lee himself. The papers date back 5 years. Is 5 years too “recently published” as well?

The key to all this is understanding conformations of double-stranded DNA, especially when bound to aluminum salts. This is all about developing a PCR method to detect DNA fragments in various conformations.

Utter nonsense. The article shows nothing of the sort. What Lee did was a simple nested PCR followed by Sanger sequencing, detecting a single gene from HPV that is not vaccine-specific.

The paper contains absolutely no methodology to investigate “various conformations” of DNA, nor any evidence to that question at all.

If you disagree, feel free to point me to the experiment and results in the article you feel demonstrate that the HPV DNA is of vaccine origin and I’d be happy to explain why you’re incorrect.

@AdamG:

In addition to the zero citations his textbook chapter has, none of the papers Lee lists on his own website have any citations other than Lee himself.

I will reiterate that this is not a textbook. It is volume 930 in a series. The way this works is that some poor acquisitions editor at Springer has to gin up these volumes at a certain rate to keep his gig. I’d be surprised if it were not solely print-on-demand if one wanted a bound copy. The closest analogy that springs to mind is the series of Chilton auto-repair manuals.

(Sorry, volume 903. The point stands; this is a niche reference volume carrying no intrisic weight.)

@Narad – so it doesn’t even rise to the level of a Haynes manual.

DO NOT MAKE ME GAP YOUR PLUGS.

But I think devolves onto the volume editors, MacKenzie & Henrich.

Seriously, the omniscient bimler apparently can read the minds of posters and scientists alike to accurately determine their motives.

Hello? Is Mr Black in there? I’d like to talk to Mr Black please.

Last time I checked, those journals published letters. Please point out the one from Bimler criticizing the science, because I must have missed it.

Perhaps you should check again (the tables-of-contents are on-line, so there really is no excuse to make stuff up). Journal of Inorganic Biochem does not publish letters.

@AdamG: “He fundamentally failed to provide evidence that the fragments he sequenced were of vaccine origin.”

Taken from the Abstract: “The HPV-16 gene DNA detected in the postmortem materials was similar to the HPV-16 gene DNA fragments in Gardasil in that both were in non-B-conformation”.

To repeat AdamG’s statement, Lee fundamentally failed to provide evidence. He asserts that the material detected by his recondite method was a gene “in non-B-conformation”, but this is a rationale for its fact that it did not behave like real DNA. Meanwhile the material found by his recondite method in every vaccine sample he examined also failed to behave like real DNA… therefore it also must have been in the same transient high-energy state.

Shorter: The gene found in the samples was connected to the gene found in the vaccine because neither one looked like a gene.
This is not ‘evidence’, it’s a cry of desperation. No wonder Lee is reduced to publishing in a SCIRP journal (known, among other stunts, for accepting papers written by random-text generators).

The key to all this is understanding conformations of double-stranded DNA, especially when bound to aluminum salts.

The key to all this is that Lee has presented no evidence that the DNA he claims to find wherever he looks is bound to colloidal aluminium particles. He asserts it, (A) as a Deus-Ex-Alumina explanation for why the signal he picks up looks more like random noise than like normal DNA, and (B) because the SaneVAX crowd who have bought him out are hyping an aluminium phobia as part of their scam.

I’d be surprised if [Methods in Molecular Biology] were not solely print-on-demand if one wanted a bound copy.

Doubtless a lucky guess on Narad’s part, but that is exactly how Springer describe it on the flier for the series.

Doubtless a lucky guess on Narad’s part

My dad was crazy about Elke Sommer, but that was an educated guess.

(bordering on libel) Dr. Lee
Lee can border on suing me if he has a problem. Messrs. Trahison & Clerisy (Solicitors & Commissioners for Oaths) inform me that I have a strong “bordering on truth” defense.

IANAL but I do own a copy of ‘The Goodies’ Book of [Criminal] Records’.

@AdamG: “The paper contains absolutely no methodology to investigate “various conformations” of DNA, nor any evidence to that question at all.

If you disagree, feel free to point me to the experiment and results in the article you feel demonstrate that the HPV DNA is of vaccine origin and I’d be happy to explain why you’re incorrect.”

This segment is taken directly from the paper:

“The elongated HPV16MY11+/HPV16GP6+ primers cannot be used to generate a PCR amplicon directly from the HPV-16 DNA template in the postmortem materials in this case. In comparison, the 184-bp L1 gene DNA template in the HPV-16 plasmid DNA control and in the HPV-16 DNA isolated from clinical cervicovaginal cytology samples is always successfully amplified by the 20-base degenerate consensus GP6/MY11 primer pair and by the elongated HPV16MY11+ /HPV16GP6+ primer pair under identical same-nested PCR conditions. Unlike the L1 gene in the HPV-16 plasmid DNA and in the HPV-16 isolates from clinical cervicovaginal samples, the HPV-16 L1 gene DNA fragments found in the post- mortem blood and splenic samples cannot be amplified under low stringency PCR condition and lacks a useful MY09 primer-binding site for PCR amplification. These variances in PCR amplification characteristics indicate that there are topological conformational changes in the HPV-16 L1 gene DNA fragments in the postmortem samples. Similar topological non-B conformational changes in HPV L1 gene DNA fragments bound to the AAHS particles in the Gardasil vaccine have been demonstrated by a low temperature (LoTemp) PCR catalyzed by a highly processive DNA polymerase with proof-reading function [26]. Aluminum, unlike other metals, is known to stabilize and destabilize portions of a dsDNA molecule at different pHs, cause intrastrand cross-links, and create a “non-cooperative melting profile” for the bound DNA molecule [27].”

It certainly appears to discuss why the methodology used in identfying the non-B conformation of the DNA fragments. Do you disagree with the logic or are you questionning the approach used to identify the DNA in the non-B conformation? If the DNA molecules are “twisted” or formed a knot somewhere, there is no change in the sequence, but PCR may not work in a particular location anymore due to the topological conformational changes. Similar non-B conformations were found in the Gardasil vaccine due to the aluminum. That is the evidence that leads to the conclusion that the DNA was of vaccine origin. Unless you believe there was an alternate source of DNA and aluminum in her body or another process that causes the same type of conformation.

@bimler,
So the mind reading bimler (was it you talking about a tin foil hat or someone else?) jumps back in as a pile on by regurgitating some elses argument? No original content like our departed Graham? It really isn’t mind reading if it’s already been posted. I won’t bother regurgitating the answer.

Oh, and if you’re so worried about not getting your letter published, I’m sure Merck would be more than happy to pay the fee if you want to submit something to get published and peer-reviewed since apparently, it’s only a matter of money at this journal.

Oh, and I’m sure you’re not worth suing. There is no point in a lawsuit, unless there is money after a win.

IANAL but I do own a copy of ‘The Goodies’ Book of [Criminal] Records’.

It’s whatever turns you on.

@Mr Pink:

In comparison, the 184-bp L1 gene DNA template in the HPV-16 plasmid DNA control and in the HPV-16 DNA isolated from clinical cervicovaginal cytology samples is always successfully amplified by the 20-base degenerate consensus GP6/MY11 primer pair and by the elongated HPV16MY11+ /HPV16GP6+ primer pair under identical same-nested PCR conditions.

“Always” successfully amplified? Given that Lee had no controls and his work has not been peer-reviewed, that is a questionable assertion.

Similar topological non-B conformational changes in HPV L1 gene DNA fragments bound to the AAHS particles in the Gardasil vaccine have been demonstrated by a low temperature (LoTemp) PCR catalyzed by a highly processive DNA polymerase with proof-reading function [26]. Aluminum, unlike other metals, is known to stabilize and destabilize portions of a dsDNA molecule at different pHs, cause intrastrand cross-links, and create a “non-cooperative melting profile” for the bound DNA molecule.

Again, no controls were used, you haven’t given the cites, and all we haev to go on is Lee word, which is not good enough.

[I]f you’re so worried about not getting your letter published, I’m sure Merck would be more than happy to pay the fee if you want to submit something to get published and peer-reviewed since apparently, it’s only a matter of money at this journal.

Pharma Shill Gambit again.

Oh, and I’m sure you’re not worth suing. There is no point in a lawsuit, unless there is money after a win.

Now you’re just trolling. Grow up.

Oh, and if you’re so worried about not getting your letter published, I’m sure Merck would be more than happy to pay the fee if you want to submit something to get published and peer-reviewed since apparently, it’s only a matter of money at this journal.

Please try to keep up, Mr pink. The insistence that any criticism of Shaw’s co-authored paper should be published in the journal is entirely yours (comment #323). The journal in question is “Inorganic Biochemistry”. It is not pay-to-print. No-one has suggested that it is.

The claim to have checked that the journal published letters is also yours. The statement is false; the claim to have checked it is a lie.

Looking at this in the most generous manner possible, even if we were to accept that Lee really is an expert who really has (metaphorically) written the book on high sensitivity PCR testing, there remains the problem that he neither included negative controls during the PCR amplification nor did anything afterward to determine if the sequences amplified were of vaccine origin.

That isn’t information which would be nice to have but can be dispensed with for convenience”: it’s information that is necessary and critically significan, such that in its absence Lee has no scientific basis for the claims he’s making. None whatsoever.

AFAICT, Lee’s use of controls was limited to analysing known samples of HPV and showing that nested PCR amplification can detect the unambiguous DNA:

[…] the 184-bp L1 gene DNA template in the HPV-16 plasmid DNA control and in the HPV-16 DNA isolated from clinical cervicovaginal cytology samples is always successfully amplified by the 20-base degenerate consensus GP6/MY11 primer pair and by the elongated HPV16MY11+ /HPV16GP6+ primer pair under identical same-nested PCR conditions.

The fact that the same nested-PCR technique could not detect any HPV in the tissue samples provided to Lee is his rationale for arguing that the DNA is invisible because it is in double-secret-probation conformation.

Apparently the invisible unreactive Al-bound DNA becomes reactive again when exposed to his own wild-card proof-reading polymerase. It is not clear why.

Entirely off-topic:

I have wondered where everybody is for the last few days. Evidently I needed to be speedier in catching up on my RSS feeds. Now I know and will try to catch up with this 300+ comment conversation…

@ flip:
Where’ve you been? At the AUS Open?
Right, I hear reports about the temperature of the courts’ surface. What do people do in such heat- drink or something? Makes sense.

@DW

No, I’ve just had a lot of work come up over the last few weeks. Not even had time to watch the Open on TV. — As for the heat, it depends. It can actually get so hot that they stop playing until it cools down. Otherwise, yes they drink lots, take more breaks (I think), and get handed towels. Basically it’s a “play til you drop” situation 😉

@bimler “The claim to have checked that the journal published letters is also yours. The statement is false; the claim to have checked it is a lie.”
Not a lie, a mistake. But then your readily available court documents outlining a lack of validity of Dr Lee’s tests or shakedown might qualify for lie? What does the mind reading of everyone else’s motives count as? The implied permanency of expertise? Lies or delusion? Here, I’ll make another speling mistake so you can find something original to write about.

@bimler “The fact that the same nested-PCR technique could not detect any HPV in the tissue samples provided to Lee is his rationale for arguing that the DNA is invisible because it is in double-secret-probation conformation.”
The DNA isn’t invisible. The PCR doesn’t detect the HPV in the tissue samples because the non-B conformation prevents primer-binding at that site.

@JGC “… there remains the problem that he neither included negative controls during the PCR amplification nor did anything afterward to determine if the sequences amplified were of vaccine origin.”

Are you referring to the negative control complaint of the OP’s long running shifting goalpost argument? That doesn’t make a whole lot of sense when you’re talking about a case report. Dr. Lee documents the use of negative controls in his paper, but obviously not population based ones. The case report is the next natural step in the progression of discovery in this Gardasil fiasco. In fact, if we go back to Orac’s original OP over a year ago, you’ll find him whining about the lack of documentation of methods and findings (i.e. a case report like this). Some people seem to think that pointing out the obvious — a missing or incomplete next step — is a logical complaint about the current step in the scientific process.

One job of a case report is to document unique findings and methods in order to allow others to reproduce and another is to help guide future research. This paper does both. The unique finding is that there was HPV DNA found in the autopsy which matched a very unique conformation only found in the Gardasil vaccine to date. Many people have been looking at HPV in tissues for a long time and this has not been documented anywhere.

The methods are well documented so others can validate the results if they feel necessary. However, some of the findings have obviously been replicated by the FDA as they state the DNA is present despite attempts to filter them out during the manufacturing process. Obviously we don’t know what methods they used to detect the fragments since they haven’t published any papers on the subject.

Finding this DNA in non-B conformation is also important because these were found 6 months post vaccination. Typically, DNA fragments like this should have been processed and eliminated by the body in short order not persisted for anywhere near 6 months.

As for population studies, that is the pervue of the manufacturer or the FDA. Right now, the evidence points to a situation that should not exist. They should be testing to see if it is prevalent in the Gardasil recipients’ population. They should also determine what biological effects this bound DNA might have on the body, since it obviously isn’t behaving as expected (i.e. quickly eliminated from the body).

If you really insist that this DNA bound to aluminum is prevalent in the general population, then why doesn’t someone offer a plausible scenario for how it could occur naturally in the body? Isn’t that what this site is all about: Scientific plausibility? The DNA bound to aluminum is there, and it is detectable repeatedly in the vaccine and it was found in this dead girls’ tissues and there is no evidence of anyone coming across it anywhere else. If you don’t think it came from the vaccine, I’m all ears for a plausible alternate explanation.

Finding this DNA in non-B conformation is also important because these were found 6 months post vaccination.

Did you suddenly forget your own, immediately preceding “argument” that “the PCR doesn’t detect the HPV in the tissue samples because the non-B conformation prevents primer-binding at that site”?

@Mr Pink:

Are you referring to the negative control complaint of the OP’s long running shifting goalpost argument?

Shifting goalposts? What were the different arguments that Lee has refuted so far? Do tell. Also, the lack of negative controls is, as JGC pointed out, a really big deal. Lee could have detected something that was not HPV. Without negative controls, there is no way to confirm that what he detected was HPV .

Dr. Lee documents the use of negative controls in his paper

Either we are reading different papers, or there are whole paragraphs there that cannot be detected by normal eyes but only by Lee’s special techniques.

while the other HPV vaccine Cervarix uses a baculovirus (insect) expression system, neither of which would be likely to drive significant expression in human cells.

Ew, now I’m imagining something out of Kafka…

As for the rest of the post… boy did *that* go over my head.

@DB

Thanks for posting the info on the AVN… I need to keep more in touch with what’s going on in my backyard and less time here 😉

@Narad “Did you suddenly forget your own, immediately preceding ‘argument’ that ‘the PCR doesn’t detect the HPV in the tissue samples because the non-B conformation prevents primer-binding at that site”
Do try to keep up. The case report describes the specific methodology used to isolate the DNA in non-B conformation which includes using different primers that bind at different points in the new topology. Did you actually read the paper? It describes all the steps in detail.

@Julian Frost “Shifting Goalposts?”
Did you read the OP I was talking about because it should be pretty obvious? I won’t do your homework for you nor will I interpret the obvious.

@Julian Front “Lee could have detected something that was not HPV.”
Really? Did you punch the sequence from the paper into Genbank? I would love to hear how a DNA sequence matching HPV isn’t HPV, controls or not. If you read the paper, you’ll note that negative controls were used to control for laboratory contamination. You do realize that Orac is talking about population controls because he wants people to think that HPV DNA in non-B conformation might be prevalent in the population, not because he thinks the DNA is something else. It’s a fascinating speculation predictably not backed by a single scientifically plausible explanation. What’s the favorite saying? “The irony meter just blew off the scale?”

@bimler “Either we are reading…”
Negative water controls are described and are clearly visible in the figures to control for laboratory contamination. No special technique required, just general reading and comprehension.

Do try to keep up. The case report describes the specific methodology used to isolate the DNA in non-B conformation which includes using different primers that bind at different points in the new topology. Did you actually read the paper? It describes all the steps in detail.

Um, yeah. Did you actually read the paper? The “non–B conformation” routine is supported by a self-citation. Is it time for image analysis of the blots?

First, let me repeat something:

“What might be more interesting is to know why he’s bothering with this act. Is he a SaneVax devotee (or employee), for example.”

Why is “Mr Pink” even doing this “defence” of Dr. Lee’s work in the first place?

‘Mr Pink’ wrote: “Orac is talking about population controls because he wants people to think that HPV DNA in non-B conformation might be prevalent in the population, not because he thinks the DNA is something else”

This is putting words/ideas in other’s mouths. (It’s telling I think that MP “insists” this must be trying create a conspiracy by lying. In my experience this sort of think is often the writer (Mr Pink) projecting their own line of thinking on other’s actions.)

From the OP, Lee: “is aiming to detect the vaccine strain sequence; so detecting any natural HPV that might have come from warts or other HPV infections would actually be counterproductive to what he’s trying to accomplish”

There’s one need for controls there. (There are others.)

Mr Pink ranted
“Do try to keep up. The case report describes the specific methodology used to isolate the DNA in non-B conformation which includes using different primers that bind at different points in the new topology. Did you actually read the paper? It describes all the steps in detail.”

No Mr. Pink, the method in the paper did not do that. The DNA was isolated in Auckland Hospital. Lee used a low-temp PCR with fairly non-specific primers to find some DNA that might contain HPV sequence. As Lee knew the sequence of HPV, the best strategy would have been to use a high-temperature PCR with specific primers, so he didn’t end up with all the crap his reaction produced. What Lee did do was increase the probability of false positives.

Mr Pink ranted:
“Really? Did you punch the sequence from the paper into Genbank? I would love to hear how a DNA sequence matching HPV isn’t HPV, controls or not.”

Mr Pink, the sequence is HPV, but it is smack in the middle of the virus sequence. It could have come from a virus anywhere – possibly even from the person running the assay. This is not evidence the DNA came from the vaccine.

Dr Lee’s super special, high sensitivity PCR technique would find DNA “from the vaccine” in anyone infected with HPV. (The only thing special about Lee’s PCR technique seems to be the first step that guarantees a lot of junk will be picked up, necessitating a nested approach. Then he does a second nesting with the same primers just to make sure any false positive will be highly amplified.)

Mr Pink ranted:
“Negative water controls are described and are clearly visible in the figures to control for laboratory contamination. No special technique required, just general reading and comprehension.”

Mr Pink, you seem to be just as ignorant about controls as you are about PCR. The negative controls in the paper only look for priming artifacts (they don’t actually control for laboratory contamination). They also do not look to see whether the assay picks up something other than what Lee thinks it does.

@AdamG “…because he knew that with this large of a design flaw he stood no chance with peer review.”
FYI, this paper as well as all of Dr. Lee’s other papers passed peer review and the material in the book chapter was all based on peer reviewed papers.

@Grant “Why is “Mr Pink” even doing this “defence” of Dr. Lee’s work in the first place?”
The better question is why you came back Grant? I mean you ran off to parade out a pair of hippie parents — who don’t know how to take care of their kids — as people the rest of us should mimic? Thank goodness you told all the hippies to have their kids get vaccinated, they’ll need it. As for coming back, according to your own argument that makes you a dupe again! Maybe you came back to tell us about the chapter you wrote for a textbook. Can you back your argument with more than hot air?

@Grant “This is putting words/ideas in other’s mouths.”
Sorry Grant, no conspiracy. It comes straight from the OP: “Basically, he tested DNA from tissue samples from one young woman. There are no controls. How many people in the general population would test positive using Sin Hang Lee’s methodology? ”

@Grant “There’s one need for controls there. (There are others.)”
Apparently, you didn’t read the case report? The HPV DNA was not in it’s naturally occuring conformation. It was twisted and bound to aluminum in a way that was quite unique hence the case report. Dr Lee has been testing tissue samples of HPV (including cervical cancer samples) for a long time so I doubt he would write a paper about the uniqueness if it could have come from a wart. HPV DNA might come from warts but how do you figure it got twisted and bound to the aluminum?

@Mr Pink:

The HPV DNA was not in it’s naturally occuring conformation. It was twisted and bound to aluminum in a way that was quite unique hence the case report.

Once again, all we have to go on is Lee’s word that the DNA was bound to the aluminium adjuvant in a way that was distinctive. Secondly, as ChrisP pointed out, “It could have come from a virus anywhere – possibly even from the person running the assay.” If HPV DNA can bind to the aluminium adjuvant in a distinctive manner, so can DNA from other sources. Hence the need for controls.

The HPV DNA was not in it’s naturally occuring conformation.

You apparently didn’t notice that ChrisP has handed you your hat. And the putative conformation is still a claim based on exclusion. It’s a weak inference supported, to repeat myself, by self-citation.

Mr Pink, there is no evidence presented in the paper that HPV was in any specific confirmation. No aluminium was measured. All there is is speculation based on Lee’s previous speculation in some equally poor papers.

There was nothing special about the DNA extraction technique used by the Auckland Hospital. The reason Lee didn’t clearly find HPV with his first DNA assay was because he used low-specificity primers at low annealing temperatures. Any HPV DNA present would have been amplified with a pile of junk. That is obviously why he had to go to the nested approach.

What strikes me as unusual about this paper (apart from the very peculiar way it reports the results – who includes sequencing chromatograms anymore?) was that if I wanted to guarantee picking up a human virus contaminant in my DNA sample, this strikes me as a surefire way of going about it.

FYI, this paper as well as all of Dr. Lee’s other papers passed peer review

This just reveals how poorly you understand the peer review process. Not all peer review is created equal…

Question for you, Pink. Why did Dr. Lee, PCR ‘expert,’ choose not to publish this article in Am J Clin Pathol, where he’s published 3 other articles?

Here’s a hint: the article doesn’t show what he claims it shows, and he knows it.

FYI, this paper as well as all of Dr. Lee’s other papers passed peer review

SCIRP journals have accepted papers composed by random-number generators.
SCIRP journals have plagiarised papers from real journals in an attempt to create a false impression of their standards.
SCIRP journals have stolen the identities of experts in a field and listed them as members of the editorial board, without informing them or sending them papers to review (naturally unwilling to reveal the fraud).
They also claim to have peer review.

Some 95%-snark-free questions for experts in the field:

1 Does DNA in fact bond to aluminium-salt colloidal particles? (I know that aluminium ions in solution will bond to DNA under the right conditions, but that is not the situation for vaccine adjuvants).

2 If DNA did hypothetically bind to a colloidal aluminium-compound particle — with sufficient stability to stay bound for 6 months — is there any reason to expect it to assume a non-B conformation?

3 Would DNA replicate when in a non-B conformation, even with a patent LoTemp polymerase? My vague recollection is that it is placed into such states for the purpose of creating a m-RNA strand, when of course you don’t want DNA bases cluttering up the process. So the conformation puts the angles of the bonds all cattywampus (to use a technical term) and the DNA bases simply don’t connect.

Dr Lee has been testing tissue samples of HPV (including cervical cancer samples) for a long time so I doubt he would write a paper about the uniqueness if it could have come from a wart

The evidence that Lee didn’t make an incompetent blunder is that Lee wouldn’t make an incompetent blunder.
OK.

Dr Lee has been testing tissue samples of HPV (including cervical cancer samples) for a long time

This is not true. A look at his publication history reveals that the HPV / SafeVax work started in 2010; before that he focussed on a PCR test for borreliosis which could provide hypochondriacs with the positive diagnoses for Chronic Lyme syndrome that they were otherwise unable to obtain.

That, and selling green tea as a cure for cancer .

HDB,

is there any reason to expect it to assume a non-B conformation?

This is the real heart of the matter. The fact is, there is absolutely no reason at all to think that this DNA would form a non-B conformation.

The formation of non-B structures is mostly dependent on the composition of the sequence itself. That is, only certain sequence motifs are able to form non-B structures given the right conditions. Dr. Lee presents no evidence that the sequence in question contains such a motif.

Here’s a pretty good review of what’s known about non-B DNA in vivo:

http://www.sciencedirect.com/science/article/pii/S0968000407000916

Pay particular attention to the section that describes the methods needed to specifically demonstrate the presence of non-B DNA.

You absolutely cannot just look at a PCR that failed and conclude that must have failed because of non-B DNA! That’s just madness.

In Lee’s case he is looking at *two* PCRs that failed and concluding that *both* must have failed because of non-B DNA, therefore DNA present but bound to aluminium colloid. A stronger word than “madness” is required.

@bimler “The evidence that Lee didn’t make an incompetent blunder is that Lee wouldn’t make an incompetent blunder.”
Silly me, here I was thinking an expert opinion would outweigh a complete lack of evidence or scientific reference to the contrary. You are welcome to provide your peer reviewed evidence of such conformations existing anywhere. Frankly, the complete lack of any peer-reviewed evidence to back half the ridiculous statements made here is pretty funny. Apparently, there isn’t just varying levels of peer-review, there are also some levels of superior soap box spouting which happen to hold more weight than any of the former.

@bimler “That is not true. A look at his publication history reveals that the… ”
So not only do you think you a mindreader, but apparently believe you have a clear vision of history? You seem to forget that Dr. Lee was working for many years on low cost reliable HPV subtype identification. Assuming his work on HPV started with SafeVax is an enormously ignorant and erroneous assumption — as is relying on Orac to do his homework. If your “scientific work” relies on such brutal assumptions, I would be wary of anything you managed to publish.

@Julian Frost “If HPV DNA can bind to the aluminium adjuvant in a distinctive manner, so can DNA from other sources. Hence the need for controls.”
Your arguments are all over the map. First you said it might not be HPV, then you’re parroting someone else’ argument (a bimler fan I see) saying the HPV could come from anywhere implying it is indeed HPV. Now you propose that HPV is binding to aluminum adjuvant in the wild (an Orac mimic now)? Do tell us how you think that would plausibly occur, because you might have solved the mystery! Despite the lack of plausible alternate scientific explanation, you’re still on about population controls. In a case report to boot.

@ChrisP spouted “As Lee knew the sequence of HPV, the best strategy would have been to use a high-temperature PCR with specific primers, so he didn’t end up with all the crap his reaction produced. What Lee did do was increase the probability of false positives.”
@ChrisP spouted “The reason Lee didn’t clearly find HPV with his first DNA assay was because he used low-specificity primers at low annealing temperatures.”
You talk like you only have a rudimentary knowledge of PCR and I’m guessing you didn’t read or understand the report: “The traditional heat-resistant Taq DNA polymerase could not generate a useful nested PCR amplicon from a minute quantity of target HPV DNA in the postmortem materials to be used as a template for direct DNA sequencing.”
Higher temperature DNA replication is associated with more amplification errors (see: Fidelity of DNA polymerases in DNA amplification, Proc Natl Acad Sci U S A. 1989 December; 86(23): 9253–9257.). High temperature may also cause DNA depurination (Biochemistry 1972, 11:3610-8) and deamination (Biochemistry 1974, 13:3405-10).

@ChrisP spouted “The only thing special about Lee’s PCR technique seems to be the first step that guarantees a lot of junk will be picked up, necessitating a nested approach. Then he does a second nesting with the same primers just to make sure any false positive will be highly amplified.”

Now you are talking nonsense and not only because you don’t understand the difference between low and high temperature PCR. See “Nested PCR with the PGMY09/11 and GP5+/6+ primer sets improves detection of HPV DNA in cervical samples. Journal of Virological Methods 122 (2004) 87–93.” The secondary PCR of the PGMY/GP+ system showed consistently detection of HPV DNA at one copy.

You can put many pictures of a frog through a photocopier, but I guarantee the copies will not show a picture of a person in the copies. Now, if you take a picture of a frog, with a tiny image of a person embedded somewhere in the picture, you might find a photocopier that can zoom in with enough resolution to produce a picture of a person, but only if the person is there in the first place. It doesn’t matter what method you used to zoom in and make the copy as long as you find the image of the person that was already there.

@ChrisP spouted “(apart from the very peculiar way it reports the results – who includes sequencing chromatograms anymore?)”
Whine whine whine. (J Mol Diagn. 2010 Jan;12(1):27-34. doi: 10.2353/jmoldx.2010.090028. Epub 2009 Dec 3.) Various methods have been described for the detection of KRAS mutations, such as a mutagenic PCR assay, 11 pyrosequencing,12 and real-time PCR13; however, Sanger sequencing on PCR products remains the golden standard.6,14,15

@AdamG “This just reveals how poorly you understand the peer review process. Not all peer review is created equal…”
And here I thought it reveals how poorly you make your arguments because you were quite definitive that it would not pass unqualified peer review. It’s ignorant to make a black and white statement and then claim that others can’t differentiate shades of grey. That’s right out of the trolling handbook.

@AdamG “This is the real heart of the matter. The fact is, there is absolutely no reason at all to think that this DNA would form a non-B conformation…”
I already quoted the pertinent section from the case report in response #356 which you conveniently ignored. The article you referred to states: “The mutagenesis is due to the non-B DNA conformation rather than to the DNA sequence per se in the orthodox right-handed Watson-Crick B-form.” Formation of non-B structures has nothing to do with sequence itself which Dr. Lee demonstrated. That is why he showed the base-calling electropherograms as evidence. There are many ways to form non-B DNA structures. This guy mentioned “in vivo” situations, Dr. Lee dealt with “in vitro” situations with HPV DNA in vaccines.

@AdamG “You absolutely cannot just look at a PCR that failed and conclude that must have failed because of non-B DNA!”
This is a half-truth reference to the publication. There are two pieces of evidence in the paper which indicate the non-B DNA conformation: the failure of conventional PCR, but also the success of a modified PCR to detect the DNA which is NOT “in the orthodox right-handed Watson-Crick B-form”.

And here I thought it reveals how poorly you make your arguments because you were quite definitive that it would not pass unqualified peer review.

Guess what, Pink: scrip ‘peer review’ is equivalent to no peer review in my book. If this were actually peer reviewed, there’s no way Lee would have gotten by with the kind of crap he’s trying to pull with his reference 26.

Formation of non-B structures has nothing to do with sequence itself which Dr. Lee demonstrated.

Where did he demonstrate this?

the success of a modified PCR to detect the DNA which is NOT “in the orthodox right-handed Watson-Crick B-form”.

Where did he demonstrate this?

What you need to do is provide evidence that the ONLY logical conclusion that can be drawn from this ‘modified PCR’ is that the DNA is in non-B conformation and is vaccine-derived.

My lab is one of the largest sequencing centers in the country. We do more PCR in a month than most labs will ever do. I know PCR every which way from Sunday. You can obfuscate all you like, but the fact of the matter is that this ‘non-B’ baloney isn’t remotely the most likely conclusion to be drawn from this modified PCR.

@AdamG “there’s no way Lee would have gotten by with the kind of crap he’s trying to pull with his reference 26.”
Really? In quick review of 4 high impact journals in microbiology, I find 3 that allow “in press” references, while only one does not. I suppose they’re crap too: Annual review of Microbiology, Clinical Microbiology Reviews, PLOS Pathogens. If I didn’t think you were the only one here who actually read the case report through, I would accuse you of whining like a kid.

@AdamG “Guess what, Pink: scrip ‘peer review’ is equivalent to no peer review in my book.”
Witness the shifting goalpost as you change your argument to “qualified” peer review. Where is the super secret pseudo skeptic handbook that lists the “acceptable” journals for AdamG? Got a reference, is it “in press”?

@AdamG “My lab is one of the largest sequencing centers in the country. We do more PCR in a month than most labs will ever do. I know PCR every which way from Sunday. ”
That only demonstrates you are a worker, running a lot of repetitive routine procedures designed by someone else. After graduation, I worked at Eli Lilly. Did that really impress you? One of the largest sequencing centers in the country does not scare anyone.

Here’s an idea: Why don’t you do some PCR/DNA sequencing like Dr. Lee’s on Gardasil and on the postmortem blood samples stored in Auckland City Hospital to prove Dr. Lee is wrong, instead of just talking in a disreputable soap box? Forget the letter. Since you claim it’s so easy, just do the tests, write the paper, get the submission fee (or more) from Merck and publish the paper to contradict the findings. You might even get credit and it should be trivial according to you and everyone else here. You’ll even get to experience (non) peer review first hand instead of relying on innuendo and heresay. I bet Dr. Lee and everyone involved would love for someone to document their attempt to replicate the findings in either the vaccine or the tissue samples. It should be pretty obvious that Orac isn’t going to try.

Mr Pink said:

You talk like you only have a rudimentary knowledge of PCR

Snork.

From someone who apparently has little idea of how nested PCR works, hasn’t heard of proofreading taqs and then refers to a paper using a standard nested PCR to detect HPV DNA as evidence that Lee’s approach does not generate crap.

This is getting funnier and funnier.

You’ll even get to experience (non) peer review first hand instead of relying on innuendo and heresay.

Double heh.

The world of scientific publishing, in its majestic equality, allows Sin Hang Lee’s supporters as well as his detractors to submit manuscripts explaining their evidence and arguments.

Is it me or is Mr Pink using the logical fallacy of expecting someone else to prove X is wrong, instead of the claimant proving his own hypothesis right?

HPV
no negative stains in doctors work ,,,,,,,,,,,,,,,,,,,,,,,,, their is no immunity
they cannot make a a vaccine that gives immunity
he infected himself for the new strains”was he HI on something!

How does a vaccine work when acquired immunity has not been established
As in that is how vaccines work, Acquired immunity was seen and documented in man or animal and a vaccine was made that had this immunity in it ,

The Vaccine has an immunity in it, to work small pox cow pox chicken pox
ect
the vaccine for small pox and chicken pox has this immunity cell structure so the body can learn the immunity

HPV a Wart No NO no, a man or animal in history has not developed the immunity, never get anouther Wart {external, internal}

warts plantar what ever
their all a wart
where they grow, how, interior, or exterior changes the hpv strain

complicated merck made it
so MERCK are lieing

I am happy to see that e. e. cummings is alive and well and commenting at RI.

And that was the short version.

Indeed, it’s not even the first time it’s dropped this here. The tail end of the long version, though, seems like it could easily be adapted to the framework of Hunter/Garcia/Kreutzmann’s The Wheel.

i have injected the Gardasil
which was in the icebox
which you were probably saving for DILUTE DILUTE

@Mr Pink:

Your arguments are all over the map. First you said it might not be HPV, then you’re parroting someone else’ argument (a bimler fan I see) saying the HPV could come from anywhere implying it is indeed HPV.

No. I said that the DNA could have come from anywhere. I never said that the DNA was HPV DNA. What I was saying was that:
a) There is NO PROOF that what Sin Hang Lee found was HPV DNA.
b) If HPV DNA can bind to aluminium adjuvants in a distinctive manner, then so could other DNA, including Human DNA, DNA from other viruses etc.
Do try to keep up.

@flip “Is it me or is Mr Pink…”
Is it me or are unsupported opinions from sockpuppets in a soap box considered more definitive than published work in journals? Perhaps you should focus on helping Graham convince hippies that vaccinating their kids is good. That would greatly help everyone.

@bimler “The world of scientific publishing, in its majestic equality…”
Oh bimler, should I add high defender of dogmatic scientific authority to your many skills? The complaints sound similar to the defenders of monastic control of education.

@bimler “Does DNA in fact bond to aluminium-salt colloidal particles?”
The case report lists this reference: “Interaction of aluminum species with deoxyribonucleic acid, Biochemistry. 1980 Dec 23;19(26):5991-8.” In order to answer your line of questioning, you would have to know the specifics of the manufacturing process conditions of the vaccine. However, the evidence is pretty clear to those that can interpret it. Remember, Dr. Lee found the twisted DNA in the vaccine samples using the same technology and a similar approach and the FDA subsequently confirmed the results after they were made public.

@Julian Frost “I never said that the DNA was HPV DNA.”
You directly quoted ChrisP in post #378. “Secondly, as ChrisP pointed out, “It could have come from a virus anywhere – possibly even from the person running the assay.”” That quote comes from the point where ChrisP acknowledges that the DNA is HPV: “Mr Pink, the sequence is HPV, but it is smack in the middle of the virus sequence. ” That’s a definitive statement. Are you saying you agree with half of ChrisP’s argument but not the first half or the following portion which also admits it is HPV? You really are making things convoluted (even bimler doesn’t do that when parroting others). And hey, keeping up with nonsense is pretty hard to do.

@Julian Frost “There is NO PROOF that what Sin Hang Lee found was HPV DNA.”
Several of your fellow commentors appear to agree that it was HPV DNA based on the sequencing provided. When you figure out why they understand that HPV was actually found, then come back with a real argument.

@ChrisP “…hasn’t heard of proofreading taqs”
Now you are putting words in my mouth, do you guys pass the trolling handbook around? Your insistence that the low temperature PCR is somehow inferior is baffling and confounding your arguments. From the study we see Dr Lee used: “a low temperature (LoTemp) PCR catalyzed by a highly processive DNA polymerase with proof-reading function”. You can find more information about it on the internet. Based on no evidence whatsoever, you propose that using a high temperature PCR is superior. In the study “Routine human papillomavirus genotyping by DNA sequencing in community hospital laboratories” (Infect Agent Cancer. 2007; 2: 11.), Figure 1 showed the enzyme is much more effective in amplifying HPV-16 DNA than Takara Taq (taq which claims to proofread). If you read the Springer 2012 Chapter 5 referenced earlier, Figure 2 clearly shows that without using the low temp enzyme, a Taq polymerase under identical experiments generated false negative HPV test results in clinical specimens. Have you a single reference or I’ll even entertain a scientific argument to counter these results? So far it’s a lot of hot air vs real published evidence.

@ChrisP “…who apparently has little idea of how nested PCR works, …” and “and then refers to a paper using a standard nested PCR to detect HPV DNA as evidence that Lee’s approach does not generate crap.”
Dr Lee used a standard nested PCR approach. You are confounding the low temperature PCR technology (which is not typical) with the nested PCR approach (which should be nothing special). This all should have been obvious if you had actually read the paper through at least once. Dr Lee used a nested PCR approach and there was nothing super-secret or non-standard about it. He even used standard primers with just a few modifications as needed. The reference I used earlier was to illustrate quite clearly that a nested PCR approach can isolate HPV DNA. Your whole argument is merely a rant because you a) don’t understand the polymerase and denaturing technology used b) and you confused the technology with approach of using nested PCR. If the process OR the technology was so flawed, why would the FDA confirm Dr. Lee’s findings instead of pointing out the problems with either the technology or the approach? I do however agree with your projection of this getting funnier and funnier.

@Mr Pink

Is it me or are unsupported opinions from sockpuppets in a soap box considered more definitive than published work in journals?

That was a nice little non sequitur. But as this PCR stuff is way over my head, I was trying to understand the conversation so far…

Is it me or are unsupported opinions from sockpuppets in a soap box considered more definitive than published work in journals?

Based on the way you seem to define “sockpuppets in a soap box” (i.e., anyone who disagrees with you) and “journals” (i.e., anything that pretends to value academic integrity, no matter how obviously that pretense is shown over and over to be false, then yes. You made the choice to set the bar extraordinarily low. It’s like stentoriously declaring “Who’s more trustworthy: some random person encountered at a bus stop, or a financial professional with years of experience??” If in fact the “financial professional with years of experience” you’re talking about is Bernie Madoff, then the answer is “probably the random person at the bus stop”!

Whatever the definition of “definitive” in relation to science is (it’s certainly not what you seem to think it is) it doesn’t come from mere membership in a category such as “articles published by journals”. Every retracted article was once an article published by a journal; which of the following are you going to argue?

A) Those articles, by virtue of having been published in a journal, remain “definitive” even after they’re retracted;
B) Those articles magically transmogrified from “definitive” to “non-definitive” at the exact moment the editor of the journal pressed the key that sent the e-mail that said “we’re retracting this.”
C) These articles never were definitive; at best, they merely looked like they were, and that only until the flaws in them were exposed. (It follows logically that as a defense to the exposure of flaws, “it was published in a journal!!” blows goats even when it’s a real journal.)

@AdamG “there’s no way Lee would have gotten by with the kind of crap he’s trying to pull with his reference 26.”
Really? In quick review of 4 high impact journals in microbiology, I find 3 that allow “in press” references, while only one does not. I suppose they’re crap too: Annual review of Microbiology, Clinical Microbiology Reviews, PLOS Pathogens.

Apparently, you fail to grasp that SCIRP journals are going to remain crap no matter what further cluelessness you try to throw at the operation. Moreover, you do not seem to understand why review journals are an inapt comparison, that Advances in Bioscience and Biotechnology isn’t actually a journal “in microbiology” in the first place, and that the forward reference is just to another purchased SCIRP entry.

(Moreover, as far as the “in press” angle is concerned, no, they are not kosher as the lone support for an important claim. This should have been moved to the conclusion and described as what it is.)

I see there’s been quite a bit of activity on this thread over the weekend…most of your nonsense has been dealt with already luckily. A few remaining points though.

Your continued defense of the scrip journals is baffling. Lee himself has published in better journals. Why didn’t he publish this one in those better journals? You can rationalize all you want but the simple fact of the matter is that he couldn’t.

That only demonstrates you are a worker, running a lot of repetitive routine procedures designed by someone else.

Oh, honey, you’re adorable. If you only knew how wrong you are. Who do you think designs the procedures?

There are two pieces of evidence in the paper which indicate the non-B DNA conformation: the failure of conventional PCR, but also the success of a modified PCR to detect the DNA which is NOT “in the orthodox right-handed Watson-Crick B-form”.

We’ve already explained why the failure of a PCR is not sufficient evidence to show that the DNA is vaccine derived. As to the other point, Mr. Pink is making the following argument:

A. LoTemp PCR can detect DNA which is NOT in the orthodox right-handed Watson-Crick B-form.
B. The LoTemp PCR produced a band of the expected length.
therefore,
C. The detected DNA is vaccine-derived.

For the evidence of claim A, Lee cites is own paper (reference 9), the title of which is “Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®”

Note the “possibly,” which i suspect may have been added on peer-review (ACTUAL peer review). You can’t just jump to conclusion C as if it necessarily follows from claims A and B. There are lots of other explanations for these results, especially in the absence of a proper negative control (i.e. the exact same assays on an unvaccinated individual).

Without going too deep into that paper (which I also have major problems with), Lee himself In his own paper (ref. 9) says

This report provides the first evidence that a chemical binding may have occurred between naked DNA fragments and an aluminum-based adjuvant to form a highly stable complex in a vaccine. However, the evidence is still indirect. Such a new chemical complex may need direct physical analyses of the molecular structure for final validation.

but then, in the scrip paper, Lee says

The general method used to detect HPV L1 gene DNA by heminested (nested) LoTemp® PCR amplification[…]has been described in detail elsewhere for clinical samples [20-25] and for detecting residual HPV DNA fragments in the Gardasil[9]

See the shift there? That’s not what reference 9 shows. Not without the further study that Lee himself recommends. So suddenly we’re expected to take the claim as absolutely true without any further study? And then you come here and whine at us about how we ‘just don’t understand PCR’ when we say we’re not convinced by the evidence Lee himself presents? What a load of crap.

By the way, Mr Pink, you seem to be taking this all pretty personally…don’t you think it’s a little disingenuous that Lee declares no conflicts of interest despite the fact the he has a clear financial interest in the LoTemp PCR system?

If this is the kind of science Lee practices, it’s a very good thing that nobody reads or cites any of his articles.

@Narad “Apparently, you fail to grasp that SCIRP journals are going to remain crap no matter what further cluelessness you try to throw at the operation.”
You must be projecting again. I never threw anything at SCRIP, that was you and others here. I’m justing pointing out how ridiculous the whining about the journal of publication is around here is, especially when the details of the science are laid out quite clearly for all to read and even reproduce. The evidence on display would indicate that most people here did not even do that properly. Half of the detracting commenters can’t even comprehend that the sequence published actually matched HPV DNA or that a standard nested PCR approach was used or that it is an accepted approach to HPV serotyping and identification. And the complaints about super secret PCR technology arbitrarily producing crap when there exists peer reviewed articles about it’s effectiveness? Maybe you also think that case reports should have population controls and that a “real” peer-review would have pointed that out? But don’t let all those ridiculous assertions stop you from trolling on about critical flaws like typos and the journal of publication.

@Narad “Moreover, you do not seem to understand why review journals are an inapt comparison,…”
Another half fact. PLOS Pathogens wasn’t a review journal when I looked it up and they publish case reports in addition to being a top ranked high impact journal. Or does every open access journal fall off the super secret skeptic list of approved journals? Perhaps the high guardian of scientific authority bimler could help us out here?

@Narad “…that Advances in Bioscience and Biotechnology isn’t actually a journal “in microbiology” in the first place…”
Oh, I know it isn’t microbiology, that’s pretty obvious from the titles alone. Microbiology was chosen because it had readily published high impact journal lists. Is there a better category? Probably. Ah, I see, the spelling troll cares. The PLOS Pathogens journal is not a review journal, is very high impact, publishes case reports, and allows “in print” references without special conditions that you appear to think should exist. Perhaps you should write them and complain about their shoddy practices?

@Narad “and that the forward reference is just to another purchased SCIRP entry.”
Here we go again back to the last refuge of the losing argument: “that journal isn’t on the super secret pseudo sketpic approved journals list”.

@Narad “(Moreover, as far as the “in press” angle is concerned, no, they are not kosher as the lone support for an important claim. This should have been moved to the conclusion and described as what it is.)”
That is a pretty disingenious argument since this study is greenfields work. There aren’t likely to be any other references dealing with this situation are there?
Additionally, in all three author guidelines I listed, I found no distinction surrounding the use of “in press” vs published work providing that the “in press” work had been accepted for publication. Perhaps you should inform them all that their guidelines don’t live up to “Narad of the Orac” standards. I suspect you’ll be busy because it looks like there are a lot of journals apparently doing it wrong.

@Antaeus Feldspar “Based on the way you seem to define “sockpuppets in a soap box” (i.e., anyone who disagrees with you)”
Welcome Antaeus. You kind of missed the boat on that observation. The “sockpuppet” titles are generally reserved for the ones employing tactics from the trolling handbook which I make sure to point out. It is subtle, so I can see why you missed it.

@Anteaus Feldspar “… (i.e., anything that pretends to value academic integrity,…”
I guess you didn’t realize the question was rhetorical because you wrote a long, weird answer. I sincerely hope you didn’t spend too much time on it. I politely suggest that if you take a small sample of this blog, you’ll find many many examples of the same. However, you actually make some good points that are worth discussing. It’s the details of the situation that ultimately matter isn’t it (i.e. Madoff, vs person at the busstop)? Given that most of the people here want to broad brush the work away based on the place of publication, they clearly don’t understand that point.

If you mean to imply that the published work I cited — yes, sadly, no one else cited anything here — may not be reputable, it is true. That might always be a possibility with any published work. However with the exception of one commenter discussing one paper, there is an absense of arguments let alone logical ones against the published work. So I feel pretty safe assuming that published works by an expert — whose methodology paper on HPV genotyping is the top download for a cancer journal — is not going to be retracted any time soon.

@flip “That was a nice little non sequitur. But as this PCR stuff is way over my head, I was trying to understand the conversation so far…”
I suggest reading the paper through first. From what I can tell, only one serious commenter here seems to have bothered.

@AdamG “Your continued defense of the scrip journals is baffling.”
Please point out where I am continuously defending the journal of publication? I don’t need to defend the journal because arguing that a paper is bad based on where it was published is not a logical argument. The NEJM published and repeatedly re-published the bogus Vioxx study and had little remorse for the estimated tens of thousands of deaths that fraud caused. Am I justified in disregarding every article ever published there without ever reading them?

@AdamG “Why didn’t he publish this one in those better journals? You can rationalize all you want but the simple fact of the matter is that he couldn’t.”
That’s conjecture not fact. Like I said above, it is not relevant.

@AdamG “A. LoTemp PCR can detect DNA which is NOT in the orthodox right-handed Watson-Crick B-form.”
Just like any other PCR technology if it is sensitive and specific enough. Additionally, the LoTemp PCR may be able to detect non-HPV DNA in this particular case as shown by Dr. Lee. There was no claim that it can detect all non-B DNAs.

@AdamG “For the evidence of claim A, Lee cites is own paper (reference 9), the title of which is “Detection of human papillomavirus (HPV) L1 gene DNA possibly bound to particulate aluminum adjuvant in the HPV vaccine Gardasil®””
I think you are inaccurate in your paraphrasing. I don’t agree that reference 9 was used to prove what you are asserting here. When a dsDNA does not behave like the “conventional” DNA and does not show a mutation in DNA sequence, it is commonly referred to as “DNA in non-B conformations”. This can be seen in basic science publications, for example: Chromosomal instability mediated by non-B DNA: Cruciform conformation and not DNA sequence is responsible for recurrent translocation in humans. Genome Res. 2009 February; 19(2): 191–198. In Dr Lee’s articles, for example, the HPV-16 L1 gene DNA fragments in Gardasil cannot be amplified by a set of degenerate consensus GP6/MY11 primers, like the conventional HPV-16 L1 gene DNA in a control HPV-16 plasmid. By definition, the HPV-16 L1 gene DNA fragments in Gardasil, are considered in non-B conformation.

@AdamG “Lee says: (The general method used to detect HPV L1 gene DNA by heminested (nested) LoTemp® PCR amplification[…]has been described in detail elsewhere for clinical samples [20-25] and for detecting residual HPV DNA fragments in the Gardasil[9]) See the shift there? That’s not what reference 9 shows. Not without the further study that Lee himself recommends. So suddenly we’re expected to take the claim as absolutely true without any further study? And then you come here.. blah blah blah”

Reference 9 was quite definitive in finding HPV DNA fragments in Gardasil and that is exactly how the reference was used in this quote (oh and don’t forget, the FDA confirmed the finding). The part from the J Inorg Chem paper that required more study was the suggestion that it was a chemical binding that occurred between the DNA fragments and the amorphous aluminum hydroxyphosphate sulfate (AAHS) adjuvant resulting in a highly stable complex. There are different levels of evidence to validate a new chemical complex or a new compound which is not expected to be present. As Dr. Lee stated in the article that AAHS is the only proteinase-resistant insoluble compound in the vaccine Gardasil. Unless of course, you know there are other unnamed particles in all Gardasil lots? When these nanoparticles are shown to contain HPV L1 gene DNA fragments, Dr. Lee stated that there is a chemical bond between the HPV DNA and the AAHS particles, based on his biochemical and electrostatic charge studies carried out in a molecular biology laboratory. However, since the chemical compound consisting of HPV L1 gene DNA fragments and AAHS is a new compound, to be absolutely certain of the nature of a chemical bonding, like any new compound discovered, it really needs direct physical analyses of the molecular structure for final validation to satisfy the criteria required by physicists or inorganic chemists. However, in the practice of biomedical science, a final validation of the physiochemical structure of a new compound of interest is often not crucial prior to the compound being used or dealt with in applied biological science. For example, the mechanism of binding between the HPV VLPs and the AAHS in the vaccine Gardasil is still uncertain (Human Vaccines 2007; 3:139–146), and as discussed in Dr. Lee’s paper published in J Org Biochem. Yet, Gardasil has been approved for vaccination, assuming that the antigen VLPs are somehow bound, attached or trapped to the AAHS adjuvant.

The irony here is that the findings in this latest paper — which happen to qualify as further investigation — indeed support the notion proposed in the first study that a highly stable complex was formed in the vaccine between AAHS and HPV DNA fragments.

@AdamG “Note the “possibly,” which i suspect may have been added on peer-review (ACTUAL peer review). You can’t just jump to conclusion C as if it necessarily follows from claims A and B. There are lots of other explanations for these results, especially in the absence of a proper negative control (i.e. the exact same assays on an unvaccinated individual).”

Again, the “possibly” applies to the “bound to particulate aluminum adjuvant”, NOT the detection of the HPV L1 Gene DNA. As for “lots of other explanations”, that’s a crock. I’ve been waiting for a single plausible suggestion for how that very unique complex only found in Gardasil vaccine could somehow be found in post mortem tissues. None has been forthcoming, so your statement is greatly exaggerated if not flat out wrong.

@AdamG “Oh, honey, you’re adorable. If you only knew how wrong you are. Who do you think designs the procedures?”
No, not wrong. You made an unqualified claim to be employed by a huge lab in the US and implied that information conveyed expertise. The worst and most likely case of a worker in a huge lab is exactly what I stated, nothing more. Congratulations to you if you have done better, especially in this economic climate. I grant you one thing: that I think you are the only one here who actually read and comprehended the case report. What knocks your credibility is your active participation in a vitriolic unprofessional blog that is far from accurate or scientific by intent. You’ve already adopted some of the bad habits from this place — like making broad unsupportable statements of fact — but I think you still have promise. So you’ll have to forgive me if I still don’t take you at your word.

@AdamG “By the way, Mr Pink, you seem to be taking this all pretty personally…don’t you think it’s a little disingenuous that Lee declares no conflicts of interest despite the fact the he has a clear financial interest in the LoTemp PCR system?”
You accuse me of taking this personally in the same post you retort with a patronizing term of endearment? Too funny. If you’re really as smart as you think your are, you should have figured out long before now that I’m not Dr. Lee or related to his company especially if you’ve read his work. As for conflict of interest, I might agree there is a chance for that perception, but in reality, this paper was about the findings in the tissue sample and had little to do with the technology being used. The paper was not designed to compare or push the PCR technology. It was designed to report the findings of an investigation which has no impact on the financial outcomes of the technology.

But since you brought up the topic of personal interest and technology, did you look at the pricing of the tests the company is selling? No one is going to get rich on that. Contrast that to large costs associated with doing diagnostic tests at big labs. You see, your lab isn’t interested in lowering the costs of PCR diagnostics, or with enabling hospitals or clinics do their own sustainable cost effective PCR tests themselves. It would help bring health care costs down to a long term sustainable level. But then, it would also take a chunk of big money out of big PCR sequencing labs, and of course jobs like yours would go with it. Talk about a personal financial interest in badmouthing technology or anyone associated with it.

@AdamG “nobody reads or cites any of his articles.”
Thanks for providing another great example of overbearing statements of fact. If no one reads Dr Lee’s articles, how do you figure his methodology paper got to the top of the most accessed article of all time here: http://www.infectagentscancer.com/mostviewed/alltime . Orac (by name), AdamG, bimler, chrisP, and narad are all notably absent from that list. Be sure to let us all know when a published article of yours comes even close.

@Narad “Apparently, you fail to grasp that SCIRP journals are going to remain crap no matter what further cluelessness you try to throw at the operation.”
You must be projecting again. I never threw anything at SCRIP, that was you and others here. I’m justing pointing out how ridiculous the whining about the journal of publication is around here is, especially when the details of the science are laid out quite clearly for all to read and even reproduce.

You must be failing to read. There’s nothing “ridiculous” about pointing out that the entire SCIRP stable is prima facie suspect. They’ve republished other articles as whole numbers to make it appear that something they’ve concocted actually has submissions and offered lame excuses when this was detected. They’ve “added” members to editorial boards who not only didn’t consent, but also have no relationship to the field whatever.

I’m afraid I’m going to do these one at a time, as I’m trying to get some cooking done.

@Narad “Moreover, you do not seem to understand why review journals are an inapt comparison,…”
Another half fact. PLOS Pathogens wasn’t a review journal when I looked it up and they publish case reports in addition to being a top ranked high impact journal. Or does every open access journal fall off the super secret skeptic list of approved journals?

What I stated wasn’t a “half-fact.” It was you who seized on the “in press” angle, and you who presented two review journals out of three as some sort of weird attempt at rebutting what you had concluded was the point, as well as a third, similarly incommensurate to ABB, journal. Now you seem to think that arguing that the last one, PLoS* Pathogens, is a decent journal somehow exonerates the SCIRP stinkfactory. This is simple evasiveness. In my neck of the publishing woods, “in press” is no big deal, thanks to the arXiv and the fact that the status of those references is nearly uniformly verifiable. One still doesn’t use them for anything crucial.

* Sorry, guys, you put it on the mug. You’re stuck with it.

Actually, I’ll just skip to the petard at the end to save tedious repetition.

Additionally, in all three author guidelines I listed, I found no distinction surrounding the use of “in press” vs published work providing that the “in press” work had been accepted for publication.

I initially suspected this was the case. Confusing manuscript preparation guidelines for editorial standards just leaves me speechless.

@Mr Pink

In my own “defense”, I haven’t bothered to read the paper because I am an artist and half the time struggle to keep up with the science posted here. I’m learning, but I daresay I would be foolish in relying on my own lack of intelligence in PCR to be able to interpret it properly. I rely on scientists (ie. Orac and the commenters) in such cases as this and I am doing my best to follow the conversation so I can learn something. Please continue your banter and pretend that I wasn’t defending or criticising anything; but rather asking a question to help me summarise and understand your position given that your comments are often long and laden with scientific terms.

And again, you have not responded to my point, which is that it seemed like you want people to prove this paper wrong, rather than for the person who wrote it to back it up with evidence.

CORRECTION: in post #412 “…accepted approach to HPV serotyping and identification.” should read “…accepted approach to HPV genotyping and identification.”

@Narad “You must be failing to read”
No, you accused me of defending SCRIP journals (plural). I pointed out to you that I was not defending the journals. I am mocking your illogical argument against a paper based on the journal of publication.

@Narad “There’s nothing “ridiculous” about pointing out that the entire SCIRP stable is prima facie suspect.”
There is if the intent is to discredit the science of the paper based on the journal of publication. When did that become a scientific or logical argument? Is that the modus operandus (since you seem to be fond of latin) outlined in the super secret skeptic book?

@Narad “They’ve republished other articles as whole numbers to make it appear that something they’ve concocted actually has submissions and offered lame excuses when this was detected.”
Kind of like offering lame excuses when the NEJM was exposed for suspecting fraud which killed tens of thousands of americans. Apparently malfeasance isn’t exactly limited to SCRIP journals. How many people did the whole number article kill? Do you disregard all articles from the NEJM with a sweep of the hand?

@Narad “They’ve “added” members to editorial boards who not only didn’t consent, but also have no relationship to the field whatever.”
I must have missed the part when you pointed out the members of the ABB editorial board that were not related to bioscience or biotechnology or that didn’t consent to their position. Please point out the fraudulent names. Do you really not understand the fallacy of the anecdote? Elsevier created a fraudulent journal just for Merck to publish marketing “science” about Vioxx. Do you disregard every article in every journal published by Elsevier now?

@Narad “What I stated wasn’t a “half-fact.””
It was in the context of your rant/argument. You broadly accuse me of inapt comparisons by selectively using some of my examples. If you prefer the term misleading to “half-fact”, consider it changed.

@Narad “Now you seem to think that arguing that the last one, PLoS* Pathogens, is a decent journal somehow exonerates the SCIRP stinkfactory.”
Again, you are projecting. I never made any attempt to exonerate SCRIP publishing of anything. AdamG made a very specific comment implying that the use of an “in press” reference would not pass regular peer review. I think it’s pretty clear by now that what you consider decent peer reviewed journals allow the use of “in press” references and they make no special conditions about their use in the author or editorial guidelines. What is truly baffling is that in the face of contradicting evidence you appear to insist that this use is still somehow unacceptable in decent journals.

@Narad “I initially suspected this was the case. Confusing manuscript preparation guidelines for editorial standards just leaves me speechless.”
Good grief Narad, the editorial guidelines are quite explicit and make no mention of any restrictions regarding the use of “in press” articles. I’m not the one clinging to an argument in the face of illogical anecdote and contradicting evidence.

@flip “you have not responded to my point”
The wild accusations — most of which have now been debunked by other commenters one point at time — are not substantiated, unlike the paper itself. When you have a published paper with references, the onus would be on those throwing about broad generalizations to back up their statements with something substantial. Not the other way around. The science was published, with all the detail. If someone claims a contradicting argument based merely on “expertise” which can’t be substantiated, then they should put their money where their mouth is. I have supported many rebuttals here with referenced work. How many references did you read from the others here?

@flip “…because I am an artist and half the time struggle to keep up with the science posted here. I’m learning,…”
Good for you. I sincerely hope you succeed in your artistic endeavors as it is a tough time now for any profession let alone artists. I have a brother who is an artist(a musician) and a son who loves drawing and painting classes. I will point out that “scienceblogs” is a marketing term, and not necessarily a title indicating anything in particular. I also ask you to consider carefully if you think scientists worth learning from resort to rants and name calling under pseudonymns or make arguments based on sweeping generalizations. There does not appear to be any intention of having an honest discussion or debate. Quite the opposite, it is a clear tactic to bias the reader and polarize any discussion. I know there are far better environments to learn science in, but if you want to learn the art of a polarizing argument, you found a good spot.

CORRECTION: “Kind of like offering lame excuses when the NEJM was exposed for suspecting fraud which killed tens of thousands of americans. ” should read:
Like the NEJM offering lame excuses after they were exposed for ignoring evidence of fraud which ultimately killed an estimated tens of thousands of americans.

Good grief Narad, the editorial guidelines are quite explicit and make no mention of any restrictions regarding the use of “in press” articles. I’m not the one clinging to an argument in the face of illogical anecdote and contradicting evidence.

You plainly don’t understand what the role of those guidelines is. I hate to break this to you, Pink, but journals publishing is my racket.

OK, so now that the pot’s finally on the stove, might as well do the rest bit-by-bit.

@Narad “You must be failing to read”
No, you accused me of defending SCRIP journals (plural). I pointed out to you that I was not defending the journals. I am mocking your illogical argument against a paper based on the journal of publication.

First of all, it would help if you could remind yourself that it’s not “SCRIP,” but “SCIRP.” You are the one that started babbling about “the super secret pseudo skeptic handbook that lists the ‘acceptable’ journals.” It is you who trotted out “as for ‘publishing scam’, that reveals depths of ignorance,” indeed revealing your own depth of ignorance.

@Narad “There’s nothing “ridiculous” about pointing out that the entire SCIRP stable is prima facie suspect.”
There is if the intent is to discredit the science of the paper based on the journal of publication. When did that become a scientific or logical argument? Is that the modus operandus (since you seem to be fond of latin)

Your Latin sucks. Anyway, your point now seems to be that the journal itself matters not a whit. So why bother in the first place? Oh, right, the idea is to lend credibility. Unfortunately, ABB doesn’t do that.

outlined in the super secret skeptic book?

To wit.

@Narad “They’ve republished other articles as whole numbers to make it appear that something they’ve concocted actually has submissions and offered lame excuses when this was detected.”
Kind of like offering lame excuses when the NEJM was exposed for suspecting fraud which killed tens of thousands of americans. Apparently malfeasance isn’t exactly limited to SCRIP journals. How many people did the whole number article kill? Do you disregard all articles from the NEJM with a sweep of the hand?

Are you trying to scream VIOXXXXX!!! or something? The NEJM has zero bearing on this.

@Narad “They’ve “added” members to editorial boards who not only didn’t consent, but also have no relationship to the field whatever.”
I must have missed the part when you pointed out the members of the ABB editorial board that were not related to bioscience or biotechnology or that didn’t consent to their position. Please point out the fraudulent names. Do you really not understand the fallacy of the anecdote? Elsevier created a fraudulent journal just for Merck to publish marketing “science” about Vioxx. Do you disregard every article in every journal published by Elsevier now?

Oh, yes, I see that you are. Anyway, that wasn’t an “anecdote,” it was a fact, and Elsevier’s whoring itself out has nothing to do with the price of tea in China.

@Narad “What I stated wasn’t a “half-fact.””
It was in the context of your rant/argument. You broadly accuse me of inapt comparisons by selectively using some of my examples. If you prefer the term misleading to “half-fact”, consider it changed.

What? You simply made very poor choices, which you apparently now wish to preserve or something. My statement was neither a “half-fact” nor “misleading.”

@Narad “Now you seem to think that arguing that the last one, PLoS* Pathogens, is a decent journal somehow exonerates the SCIRP stinkfactory.”
Again, you are projecting. I never made any attempt to exonerate SCRIP publishing of anything. AdamG made a very specific comment implying that the use of an “in press” reference would not pass regular peer review.

Actually, this is thoroughly unclear to me, which I initially addressed it as an add-on. That’s for AdamG to address, but this is 100% your trip. And, again, you don’t understand where such citations (in particular, self-citations) are appropriate and where they’re not. In any event, you are very much attempting to claim that there is something intrinsically meaningful about buying pages in ABB and, apparently, ABC. Except when there’s not. Or something.

I think it’s pretty clear by now that what you consider decent peer reviewed journals allow the use of “in press” references and they make no special conditions about their use in the author or editorial guidelines.

Manuscript submission guidelines have nothing to do with the fiction of “editorial guidelines” that you have in your coconut.

What is truly baffling is that in the face of contradicting evidence you appear to insist that this use is still somehow unacceptable in decent journals.

Again, this is so far purely your clumsily assembled trip. My assertion is that they can be used in some places and in some roles but not in others. But you don’t get this, because you apparently just want to shout “peer-review science” and then have some sort of conniption when plan A doesn’t work out.

^ And “which is why I initially.” It’s unfortunate that NatGeo can’t find tech monkeys who have developed the skills to add a preview function.

@Mr Pink

When you have a published paper with references, the onus would be on those throwing about broad generalizations to back up their statements with something substantial.

Ok, so there’s one paper with references. Now all there needs to be is replication and you might actually have something… Gardasil has caused a death via DNA in the vaccine is not exactly robustly proven by one paper by one scientist. Even if said paper does have references. I have neither the memory or time to re-read comments, so if I’ve missed it where someone posted papers replicating this paper, I’d appreciate it if you’d point me there.

Good for you. I sincerely hope you succeed in your artistic endeavors as it is a tough time now for any profession let alone artists. I have a brother who is an artist(a musician) and a son who loves drawing and painting classes. I will point out that “scienceblogs” is a marketing term, and not necessarily a title indicating anything in particular. I also ask you to consider carefully if you think scientists worth learning from resort to rants and name calling under pseudonymns or make arguments based on sweeping generalizations. There does not appear to be any intention of having an honest discussion or debate. Quite the opposite, it is a clear tactic to bias the reader and polarize any discussion. I know there are far better environments to learn science in, but if you want to learn the art of a polarizing argument, you found a good spot.

Thank you for being so patronising. And I assure you, if I had the money for it, I’d be doing more learning via university. I’m not Duning-Kruger enough to think that this is a suitable exchange for a proper formal education. But I personally find the discussions here, and elsewhere (hence I did not refer to “scienceblogs”) to be educational, robust and fair when people are not continuously ignoring or avoiding answering questions.

This thread seems to be devolving… For instance, no one seems to be discussing the content of the paper anymore.

@Antaeus Feldspar “Based on the way you seem to define “sockpuppets in a soap box” (i.e., anyone who disagrees with you)”
Welcome Antaeus. You kind of missed the boat on that observation. The “sockpuppet” titles are generally reserved for the ones employing tactics from the trolling handbook which I make sure to point out. It is subtle, so I can see why you missed it.

I’m just observing that “sockpuppet” as the rest of the Internet defines it designates a specific, objective act which people either have done or they have not, and you have provided absolutely no evidence that any of the people you are calling “sockpuppets” have in fact committed that act. You can’t just rewrite language and make “sockpuppets” a word for a different, vaguely-at-best defined kind of trolling that you think everyone who isn’t you is guilty of; if you try to do that, we’ll just treat you as if you don’t actually know what “sockpuppet” means.

@Anteaus Feldspar “… (i.e., anything that pretends to value academic integrity,…”
I guess you didn’t realize the question was rhetorical because you wrote a long, weird answer. I sincerely hope you didn’t spend too much time on it. I politely suggest that if you take a small sample of this blog, you’ll find many many examples of the same.

No, I understood it was rhetorical; you don’t seem to understand that rhetorical questions can be answered. Were you under the impression that as long as you phrase it as a rhetorical question, you can make any cockamamie assertion you want and no one can dispute it? How sad for you, if that’s what you believed.

However, you actually make some good points that are worth discussing. It’s the details of the situation that ultimately matter isn’t it (i.e. Madoff, vs person at the busstop)? Given that most of the people here want to broad brush the work away based on the place of publication, they clearly don’t understand that point.

If you mean to imply that the published work I cited — yes, sadly, no one else cited anything here — may not be reputable, it is true. That might always be a possibility with any published work. However with the exception of one commenter discussing one paper, there is an absense of arguments let alone logical ones against the published work. So I feel pretty safe assuming that published works by an expert — whose methodology paper on HPV genotyping is the top download for a cancer journal — is not going to be retracted any time soon.

Except that you seem to be arguing two different things at two different times.

When people talk about the weaknesses of the paper, your response is “HDU!, that paper was published in A Journal and that means that People Who Are Experts, Unlike You think it’s okay and therefore it’s okay!”

When people then go on to address the linchpin of that argument, your argument, by pointing out that even if some journals automatically gave the papers in them an unquestionable status, the journal that Lee published in is not one of them, you then argue that it’s the quality of the paper that matters, ignoring that people started with the quality of the paper.

You can’t have it both ways. Give us a straight answer: do you think the paper should stand on its own merits, and any discussion of the journal it appeared in or the purported peer review that journal gave it is irrelevant? Or do you believe that we have to accept the authority of the paper because the authority of the journal backs it up, thus making the authority of the journal a very legitimate question indeed?

@Narad “Are you trying to scream VIOXXXXX!!! or something? The NEJM has zero bearing on this.”
I didn’t do the screaming, those are your words. It is an example that illustrates how irrelevant the publisher is when you want to evaluate the quality of a report.

@Narad “Oh, yes, I see that you are. Anyway, that wasn’t an “anecdote,” it was a fact, and Elsevier’s whoring itself out has nothing to do with the price of tea in China.”
Elsevier’s whoring is another illustration of how irrelevant the publisher is when you want to evaluate the quality of a report.

@Narad “… but this is 100% your trip.”
And you’re just trolling along for the ride to correct typos and identify bad latin?

@Narad “And, again, you don’t understand where such citations (in particular, self-citations) are appropriate and where they’re not.”
You continue to ignore the point that a self reference is appropriate when the author is the only one investigating and publishing about a new thing. Given that the reference was in the same journal I venture it was likely submitted to the editor and the reviewers.

@Narad “Manuscript submission guidelines have nothing to do with the fiction of “editorial guidelines” that you have in your coconut.”
LOL, I guess the PLOS folks must have used the wrong title. I’ll be sure to let them know.

@Narad “Again, this is so far purely your clumsily assembled trip. My assertion is that they can be used in some places and in some roles but not in others. But you don’t get this, because you apparently just want to shout “peer-review science” and then have some sort of conniption when plan A doesn’t work out.”
No Narad, you are the only one shouting in all-caps here. I get what you’re saying, I just don’t agree. Apparently, to you a differing opinion means the other person is dense and losing their calm.

@Narad “But you don’t get this, because you apparently just want to shout “peer-review science” and then have some sort of conniption when plan A doesn’t work out.”
Conniption? You sound like my mother when she got all flustered. That’s a ironic word coming from the person who just gave us examples of all caps screaming, name calling, bolding and apparently mind reading.

@Narad “… It is you who trotted out “as for ‘publishing scam’…”
“I hate to break this to you, Pink, but journals publishing is my racket.”
Are you reviving the old argument about publishing scams? I suppose you did finally find something we agree on and it’s hardly breaking news: Publishing is a racket.
There is a long list of editors who lost their jobs at your so-called “decent” journals when they veered from the priority of making money over scientific, ethical, or basic journalistic principles. http://www.the-scientist.com/?articles.view/articleNo/23880/title/Edit-at-your-own-risk/
Problems with bad articles are well known across all journals. I’m not going to disregard a paper just because it was published in a journal that you’ve arbitrarily decided is on some “bad” list.

PS: I’m still waiting for the evidence of fraud in the list of editors for ABB. Your whole argument against ABB is a broad brush tarring based on a grand total of zero applicable evidence.

@flip “Ok, so there’s one paper with references. Now all there needs to be is replication and you might actually have something… Gardasil has caused a death via DNA in the vaccine is not exactly robustly proven by one paper by one scientist. Even if said paper does have references. I have neither the memory or time to re-read comments, so if I’ve missed it where someone posted papers replicating this paper, I’d appreciate it if you’d point me there.”
The paper just got published. Expecting amyone to reproduce and publish the results inside of a couple of weeks is a tad unrealistic. It’s almost worse than expecting a case report to have population controls. Additionally, the paper does not claim to be proof of causality. It claims to be evidence indicating a connection between the death and the vaccine. Like I said earlier, I suggest you read the paper before entering a debate about it.

@flip “Thank you for being so patronising.”
You only have yourself to blame. Have you not read the most of the comments here? Claiming to be here because you want to learn about science is pretty shocking. You’ll have to forgive my disbelief.

@flip “But I personally find the discussions here, and elsewhere (hence I did not refer to “scienceblogs”) to be educational, robust and fair when people are not continuously ignoring or avoiding answering questions.”
I think if you went through an objective, robust, and rigorous analysis, you’ll find a very small percentage of the conversations on this site meet your criteria, and largely because the OP almost never does.

@Antaeus Feldspar “…and you have provided absolutely no evidence that any of the people you are calling “sockpuppets”… ”
Silly me, I was thinking that a lack of evidence was the modus operandus around here and I was trying to fit in. I mean Antaeus, did you actually read the claims in this thread and note how many were supported by evidence? Frankly, the irony is mind blowing. You coming onto a thread of RI wagging a finger because someone threw some insulting names around without spelling out the evidence for you. Do you ever actually read the OP’s? If you can’t see the deception going on here, I’m not going to help you out because I don’t care if you get it or not, and I don’t care if you think I’m wrong. As for soapbox, even the most ignorant reader here can see that one without me spelling it out for them.

@Antaeus Feldspar “you don’t seem to understand that rhetorical questions can be answered… How sad for you, if that’s what you believed.”
You obviously didn’t read all my comments or you feign ignorance. I’m guessing the former. Reading through things like the paper being discussed seems to be a challenge around here.

@Antaeus Feldspar “When people talk about the weaknesses of the paper, your response is “HDU!, that paper was published in A Journal and that means that People Who Are Experts, Unlike You think it’s okay and therefore it’s okay!””
Now you state things as fact that are not. You use “the weaknesses of the paper” as a term of fact. There has been a lot of criticism, the vast majority of which has been demonstrated as nonsense either by me, or even other commenters here. You appear to be guilty of accepting the unsubstantiated criticisms (i.e. no evidence or logic to back them up) at face value. You also seem to mix up broad generalized arguments for articulate criticism. A valid fallback to a broad generalized argument is a discussion of expertise. Were you under the impression that as long as someone asks broad sciency sounding questions, you can make the cockamamie assertion that they are “weaknesses of the paper” and no one can dispute it? How sad for you if that’s what you believed.

When people actually criticized the paper in an articulate way, I replied with arguments about the report or science and I provided evidence in the form of references. When people criticize the “expertise” of the author, I reply with arguments demonstrating expertise and/or provide evidence in the form of references. In that case, other publications qualify as evidence. When people complain about red herrings (like the publisher instead of the report itself), I continue to point out that it is an illogical argument against the report. If people come around to troll, then they might have gotten an insulting, flippant, or even rhetorical response as per Oracian protocol.

@Antaeus Feldspar “Give us a straight answer: do you think the paper should stand on its own merits, and any discussion of the journal it appeared in or the purported peer review that journal gave it is irrelevant?”
I think the answer should be pretty clear by now, especially since I’ve been answering any well articulated criticisms of the report in quite a bit of detail. If the arguments against the report are broad or generalized, then the only thing to fall back on is the expertise of the author vs the complainant.

I’m also not sure why you asked that last question. Read my response to Narad in post #412.
“I’m justing[sic] pointing out how ridiculous the whining about the journal of publication is around here is, especially when the details of the science are laid out quite clearly for all to read and even reproduce.”

@Antaeus Feldspar “…and you have provided absolutely no evidence that any of the people you are calling “sockpuppets”… ”
Silly me, I was thinking that a lack of evidence was the modus operandus around here and I was trying to fit in. I mean Antaeus, did you actually read the claims in this thread and note how many were supported by evidence? Frankly, the irony is mind blowing. You coming onto a thread of RI wagging a finger because someone threw some insulting names around without spelling out the evidence for you. Do you ever actually read the OP’s? If you can’t see the deception going on here, I’m not going to help you out because I don’t care if you get it or not, and I don’t care if you think I’m wrong. As for soapbox, even the most ignorant reader here can see that one without me spelling it out for them.

So your argument is basically:
1) “I can get away with anything as long as I pretend I see you guys doing it too.”
2) “I can accuse you guys of making accusations you don’t have proof for.”
3) “So I can accuse you guys of anything in the world, because I don’t have proof.”

Of course, the fact that your premise 1 is the notorious tu quoque fallacy means your argument is dead from the beginning.

@Antaeus Feldspar “you don’t seem to understand that rhetorical questions can be answered… How sad for you, if that’s what you believed.”
You obviously didn’t read all my comments or you feign ignorance. I’m guessing the former. Reading through things like the paper being discussed seems to be a challenge around here.

So your claim here amounts to “Somewhere in the over 400 comments on this post, there is something which completely rewrites the rules of debate and means that if I phrase an assertion as a rhetorical question, you cannot challenge that assertion. However, I will not tell you how that comment acts to rewrite the rules of debate or even which comment I’m referring to.” Since you’ve now admitted that you pull things out of your ass for which you have no factual basis, I’m going to conclude that this is just another example.

@Antaeus Feldspar “When people talk about the weaknesses of the paper, your response is “HDU!, that paper was published in A Journal and that means that People Who Are Experts, Unlike You think it’s okay and therefore it’s okay!””

Now you state things as fact that are not. You use “the weaknesses of the paper” as a term of fact. There has been a lot of criticism, the vast majority of which has been demonstrated as nonsense either by me, or even other commenters here.

Oh, “demonstrated” how? Demonstrated the same way that you demonstrated the truth of your sockpuppeting accusation, i.e., by claiming instead that you didn’t need to demonstrate it at all? Demonstrated the way you demonstrated a unilateral rewriting of the rules of debate, by pointing vaguely to the comments section and saying “it’s in there somewhere but it’s so absolutely unquestionably in support of my position I don’t dare let you get a look at it”?

You appear to be guilty of accepting the unsubstantiated criticisms (i.e. no evidence or logic to back them up) at face value. You also seem to mix up broad generalized arguments for articulate criticism. A valid fallback to a broad generalized argument is a discussion of expertise. Were you under the impression that as long as someone asks broad sciency sounding questions, you can make the cockamamie assertion that they are “weaknesses of the paper” and no one can dispute it? How sad for you if that’s what you believed.

All your sound and fury does not change the fact that the burden of proof is on Sin Hang Lee’s side to prove his novel methodology sound and if he does not, there’s no reason to believe any results he claims to have gotten with them. If Lee suddenly decided that phrenology was his basis for asserting that Gardasil is dangerous, I might have only “broad generalized arguments” against phrenology, since I’ve had better things to do than study the details of a long-discredited 19th century pseudoscience. Does that means Lee’s phrenology is to be assumed sound until “articulate criticism” proves it false to a degree that penetrates even your denial? If you think the answer is “yes,” it only demonstrates how very far you are from understanding what you argue about.

When people actually criticized the paper in an articulate way, I replied with arguments about the report or science and I provided evidence in the form of references. When people criticize the “expertise” of the author, I reply with arguments demonstrating expertise and/or provide evidence in the form of references. In that case, other publications qualify as evidence. When people complain about red herrings (like the publisher instead of the report itself), I continue to point out that it is an illogical argument against the report. If people come around to troll, then they might have gotten an insulting, flippant, or even rhetorical response as per Oracian protocol.

So I guess it must have been someone else and not you at all who posed the “rhetorical question” of whether “unsupported opinions from sockpuppets [sic] in a soap box [should be] considered more definitive than published work in journals,” then? The debater you describe in the above paragraph clearly never would have made the stupid suggestion of basing an assessment of who’s right and who’s wrong on the venues in which claims and criticisms are made, rather than their content. So I guess it must have been some other commenter going under the same name as you whose words you never tried to disavow, right?

@Antaeus Feldspar “Give us a straight answer: do you think the paper should stand on its own merits, and any discussion of the journal it appeared in or the purported peer review that journal gave it is irrelevant?”
I think the answer should be pretty clear by now, especially since I’ve been answering any well articulated criticisms of the report in quite a bit of detail. If the arguments against the report are broad or generalized, then the only thing to fall back on is the expertise of the author vs the complainant.

I’m also not sure why you asked that last question. Read my response to Narad in post #412.
“I’m justing[sic] pointing out how ridiculous the whining about the journal of publication is around here is, especially when the details of the science are laid out quite clearly for all to read and even reproduce.”

Guess what? What you say one minute doesn’t carry much weight when you’re saying the opposite the next minute. And no, you can’t be tricky and say “It’s the science that counts unless I make a vague allegation that the criticism is too broad or generalized and then I get to treat the magic words ‘appeared in a journal’ as an all-purpose defense.'” Doesn’t work that way.

@narad “You really don’t get this, do you? ABB has attempted to solicit papers by way of Yahoo Groups.”
OMG, I can’t believe that a company decided to market their services to a very targeted group of people using the internet? I mean the internet is an inferior way identify a target market and advertise products? It’s not as if the “decent” journals don’t spam email to anyone on their list (like someone who just purchased a single article) with the same sort of thing. Now I’m worried about you getting it. What rock have you been hiding under for the last decade?

@Antaeus “So your argument is basically: …”
Nope, apparently you missed the point: You win the sockpuppet argument.

@Antaeus “So your claim here amounts to… ”
Nope, you missed the point again. I answered rhetorical questions, so obviously I knew they could be answered. What a spectacularly failed attempt to manufacture words for me!

@Antaeus “Oh, “demonstrated” how? Demonstrated the same way that you demonstrated the truth of your sockpuppeting accusation,”
Cherrypicking words to make an argument? Why don’t you go read and understand the comments about the paper and point out something specific you didn’t agree with? That would save you a lot of words and time.

@Antaeus “All your sound and fury does not change the fact that the burden of proof is on Sin Hang Lee’s side to prove his novel methodology…”
Sound and fury? Save it for the regulars. The funniest thing is that you obviously don’t understand what is being discussed either. There is NO novel methodology. Nested PCR is a standard technique for genotyping HPV. If you had actually read my comments and references instead of trying to twist some bizarre new meaning out of them, you would already know that.

@Anteaus “Does that means Lee’s phrenology is to be assumed sound until “articulate criticism” proves it false to a degree that penetrates even your denial?”
Hold the presses! Did you just try to justify broad generalized arguments against a detailed scientific investigation which is spelled out in detail? Then you followed it up with comparing the nested PCR in this paper with phrenology as if that’s a valid analogy. I would have to fill this page with fancy latin to properly articulate the logical fallacies here but Narad might get upset.

@Anteaus “So I guess it must have someone else and not you…”
Earth to Anteaus: You won the sockpuppet argument. Now I’m beginning to think you deserve a sockpuppet award since you seem so personally attached to the debator who was trolling…

@Anteaus “Guess what? What you say one minute doesn’t carry much weight when you’re saying the opposite the next minute.”
Hmm, since you’re so smart, which category of poster do you think you fall into? It should explain your confusion. Here’s a hint: you haven’t posted anything about the science or the paper, and your glancing references to it totally missed the boat. Please post something about the paper science next time.

@narad “You really don’t get this, do you? ABB has attempted to solicit papers by way of Yahoo Groups.”
OMG, I can’t believe that a company decided to market their services to a very targeted group of people using the internet?

You very nearly cost me a new keyboard with that one.

@Antaeus “So your argument is basically: …”
Nope, apparently you missed the point: You win the sockpuppet argument.

If I won the sockpuppet argument, does that mean you will stop referring to people here as being “sockpuppets” when you have absolutely no evidence for that accusation? (Just kidding; I already know you won’t. I’m just making the point that “say one thing one moment and contradict it the next” is your modus operandi.)

@Antaeus “So your claim here amounts to… ”
Nope, you missed the point again. I answered rhetorical questions, so obviously I knew they could be answered. What a spectacularly failed attempt to manufacture words for me!

See above. If you didn’t think there was any problem with answering rhetorical questions, then you wouldn’t have written “I guess you didn’t realize the question was rhetorical because you wrote a long, weird answer.”

@Antaeus “Oh, “demonstrated” how? Demonstrated the same way that you demonstrated the truth of your sockpuppeting accusation,”

Cherrypicking words to make an argument?

“Cherrypicking” means taking things out of context, to make them give a different impression than they would in the original context. Are you seriously arguing that when you used the word “demonstrated” in the sentence “There has been a lot of criticism, the vast majority of which has been demonstrated as nonsense either by me, or even other commenters here” you expected people to understand “demonstrate” as having a vastly different meaning than it has in the dictionary?

@Antaeus “All your sound and fury does not change the fact that the burden of proof is on Sin Hang Lee’s side to prove his novel methodology…”
Sound and fury? Save it for the regulars. The funniest thing is that you obviously don’t understand what is being discussed either. There is NO novel methodology. Nested PCR is a standard technique for genotyping HPV. If you had actually read my comments and references instead of trying to twist some bizarre new meaning out of them, you would already know that.

Nested PCR is not a standard technique for determining the source of DNA, which is just one of the things Lee claims to have determined for which he does not have solid science backing him. Pointing out that nested PCR is a standard technique for genotyping HPV and claiming that this makes Lee’s claims standard science is like pointing to one spot on your boat’s hull that doesn’t have a leak and claiming this proves seaworthiness.

@Anteaus “Does that means Lee’s phrenology is to be assumed sound until “articulate criticism” proves it false to a degree that penetrates even your denial?”
Hold the presses! Did you just try to justify broad generalized arguments against a detailed scientific investigation which is spelled out in detail? Then you followed it up with comparing the nested PCR in this paper with phrenology as if that’s a valid analogy. I would have to fill this page with fancy latin to properly articulate the logical fallacies here but Narad might get upset.

Stop the presses: I didn’t “try to justify” broad generalized arguments, I succeeded. The burden of proof is on Lee to prove his novel methodology and until he has done that, which he hasn’t, any questions which deal with the parts he hasn’t proven are legitimate. Lee claims that his novel methodology not only verifies the existence of HPV DNA fragments in Jasmine Renata’s remains, it proves that those fragments came from the Gardasil vaccine. The only way it could prove such a thing is if all other possibilities have been ruled out and if he can’t answer the simple question “How did you rule out those possibilities?” then his claims are punctured.

@Anteaus “So I guess it must have someone else and not you…”
Earth to Anteaus: You won the sockpuppet argument. Now I’m beginning to think you deserve a sockpuppet award since you seem so personally attached to the debator who was trolling…

Oh, now you’re finally being specific with your accusations of sockpuppeting? Go ahead, make a complete accusation; tell me exactly who you mean by “the debator who was trolling.” Tell me exactly who you’re accusing me of being an alternate persona of: Bonnie Offit, Brian Deer, Spartacus? You’d be a flaming hypocrite to leave it as a “broad, generalized” insinuation, not that you haven’t established precedent.

@Anteaus “Guess what? What you say one minute doesn’t carry much weight when you’re saying the opposite the next minute.”
Hmm, since you’re so smart, which category of poster do you think you fall into? It should explain your confusion. Here’s a hint: you haven’t posted anything about the science or the paper, and your glancing references to it totally missed the boat. Please post something about the paper science next time.

Here’s a hint: Lee’s pronouncements don’t matter beans until the novel methodology behind them is proven sound. Since he has not done so, it doesn’t matter beans who points it out, only that he has not done so. “What category of poster” is absolutely irrelevant; only the accuracy of the criticism matters, and I’ve yet to see you explain how Lee has established that nothing else except Gardasil vaccination could possibly cause his nested PCR to report the presence of HPV DNA.

@AF

All your sound and fury does not change the fact that the burden of proof is on Sin Hang Lee’s side to prove his novel methodology sound and if he does not, there’s no reason to believe any results he claims to have gotten with them. If Lee suddenly decided that phrenology was his basis for asserting that Gardasil is dangerous, I might have only “broad generalized arguments” against phrenology, since I’ve had better things to do than study the details of a long-discredited 19th century pseudoscience. Does that means Lee’s phrenology is to be assumed sound until “articulate criticism” proves it false to a degree that penetrates even your denial? If you think the answer is “yes,” it only demonstrates how very far you are from understanding what you argue about.

Thank you for broadening and honing what I was getting at.

@Narad “Manuscript submission guidelines have nothing to do with the fiction of “editorial guidelines” that you have in your coconut.”
LOL, I guess the PLOS folks must have used the wrong title. I’ll be sure to let them know.

Allow me to explain this in very simple terms. Manuscript submission guidelines are an aid to copy editors. This becomes particularly important to the PLoS stable because they don’t have any. That’s all that they are. You might as well be arguing that the contents of a figure are valid because they are submitted to spec.

Mr. Pink,

It’s almost worse than expecting a case report to have population controls.

If you are arguing that a specific finding is unusual and significant, as Lee is in this case, of course it is appropriate to have population controls.

@Narad “Why did he trademark it, then?”
In your own words, allow me to explain this in very simple terms. The specific PCR technology he used is trademarked (like a better mousetrap). The methodology of detecting and sequencing HPV using nested PCR is not (like killing mice by setting mousetraps and then disposing of them). If you look up PCR kits on the internet you will find many different trademarked products across different types of PCR. It is crystal clear you don’t understand the science in this report.

@Narad “Manuscript submission guidelines… ”
Let’s get back to the real complaint then. You still didn’t address the idea that a self reference is appropriate if you are the only one who has published anything about the thing being studied. I’m sure Dr Lee would have loved to reference the similar work Merck and the FDA did but apparently, they did not publish their work.

@Antaeus “Nested PCR is not a standard technique for determining the source of DNA, which is just one of the things Lee claims to have determined for which he does not have solid science backing him.”

Nice strawman. Determining the probable source of DNA is done by a combination of various nested PCRs followed by DNA sequencing and identifying any other unique aspects of such DNA which is of course outlined in the report.

@Antaeus “Lee claims that his novel methodology not only verifies the existence of HPV DNA fragments in Jasmine Renata’s remains, it proves that those fragments came from the Gardasil vaccine. The only way it could prove such a thing is if all other possibilities have been ruled out and if he can’t answer the simple question “How did you rule out those possibilities?” then his claims are punctured.”

Nice strawman again. The methodology is not novel. Some reagents used during PCR were proprietary and trademarked. Learn the difference. Additionally, your logic is flawed. When Dr. Lee identified the unique L1 DNA in the samples of Gardasil in the prior report (which matched Merck’s specifically registered variant of the DNA), he did not have to rule out all potential sources of the DNA to safely assume it came from the vaccine manufacturing process. I can concoct a bunch of highly unlikely alternate scenarios that could potentially see that DNA mutating from something else or even a mole taking the DNA from Merck’s labs and sneaking them into Dr. Lee’s lab. No one (except maybe you) would advocate wasting time investigating them though. Did Merck investigate every possible alternate explanation for the apparent reduction of HPV cases of matching strains when they tested their vaccine? LOL, hardly. Most medical science does not work that way. You talk like a physicist discussing a mathematical proof. Sorry to break it to you, but the real world is not so definitive and medical science is very far from it.

One final note: Despite you and others whining continuously about this, not a single person here has offered a scientifically plausible alternate source for the unique non-B DNA yet. There’s irony for you.

@Antaeus “Here’s a hint: Lee’s pronouncements don’t matter beans until the novel methodology behind them is proven sound. ”

You clearly don’t get it either. Using nested PCR for amplifying HPV DNA segments is not a novel methodology. You seem incapable of discussing anything about the paper without making up a strawman argument. Let’s expand that. Given the number of times you’ve incorrectly paraphrased me, it seems like you are generally incapable of making any arguments without creating a strawman. Flip may like the strawman, but please, do yourself a favor, and learn something about the topic before you go spouting off further. It seems clear your intent is to waste space and time.

Let’s get back to the real complaint then. You still didn’t address the idea that a self reference is appropriate if you are the only one who has published anything about the thing being studied.

Not a forward, unpublished one, and certainly not one that one has purchased from the same vendor. Oh, wait.

I’ve already made the point: This should not have been attempted to be passed off as a supporting reference. Put in the freaking conclusion, already, stating that there is something more you’ve got in the pipeline.

One final note: Despite you and others whining continuously about this, not a single person here has offered a scientifically plausible alternate source for the unique non-B DNA yet.

I take it that you mean the “unique” conformation that hasn’t been demonstrated.

No-one — here or in the literature — has offered any scientifically plausible source for a purported non-B DNA, or indeed any evidence that a non-B DNA conformation was present.

Mr Pink made his first appearance in this thread (comment #291) to argue that no-one in the RI forum is competent to dismiss Sin Hang Lee’s reports, Lee being the accepted authority on the issue (in Mr Pink’s words, he is “The scientist who has basically written the book on high sensitivity PCR testing”).

Grant (comment #300) pointed out that this is a claim that lends itself to empirical proof, simply by listing all the other researchers who are using his methods or citing his accepted authority. Sadly, the opportunity was missed and the discussion turned rapidly to less empirical matters.

A hundred or so comments later, Mr Pink belatedly accepts that Lee is not an accepted authority because no-one else is using his methods:

[Lee is] the only one who has published anything about the thing being studied.

Progress!

hdb,

If “Mr Pink” could always read the examination (PDF file) of Lee’s earlier work on this matter by a New Zealand immunologist.

Worth remembering is that the author of that analysis has appropriate expertise in immunology/vaccines and is familiar with the New Zealand setting (the medical setting and the nature of coroner’s inquests in NZ, etc).

I pointed this examination of Lee’s work out earlier, but Mr Pink seems to have by-passed it. (See also my comment #36.)

@Krebiozen “If you are arguing that a specific finding is unusual and significant, as Lee is in this case, of course it is appropriate to have population controls.”
I’m guessing you don’t study HPV infections or cervical cancer because the finding of HPV DNA in non-B conformation in human tissue alone is unusual and significant. If someone detected plasmodium malariae in the blood of a native Eskimo living near the North pole, would it need a population control study to show the finding is unusual and significant? The case report finding doesn’t require a population study to confirm its significance or unusual nature. If a followup study happens to show it is prevalent in the general non-vaccinated population, then that would be another unique finding and deserving of a study paper and not a case report. Of course, if it turns out to be prevalent in the general population, then one would have to question how all the scientists — studying every conceivable disease tied to HPV so they can sell everyone the vaccine — have never come across it before.

Of course, as I’ve stated numerous times already, not a single person here or elsewhere has even attempted to propose a plausible explanation for the finding that doesn’t involve the vaccine.

@Grant “If Mr Pink…”
Back from saving hippies from their own stupidity? Did you come back to finally explain how your writing of a textbook chapter demonstrates a lack of expertise? I’ve been anxiously waiting to hear more about that one. As for your link, it’s not an examination at all, and even worse, it doesn’t reference a single paper of Dr Lee’s. Given the huge selectivity of peer reviewed journals around here, I’m shocked you would point to a simple paper (titled commentary to boot) on the internet and suggest it was a valid examination of a body of work. That’s just plain misrepresentation. BTW, does that website somehow find itself on Narad’s super secret list of approved publications?

As for your “expert” and her “commentary”, I note from her real publication history she seems to be an expert in public health and vaccine delivery (like what angle of needle one should use), not HPV genotyping or PCR testing and methodology. Perhaps she doesn’t understand the science and that explains why she didn’t bother referencing any of Dr. Lee’s published work in her “commentary”? I wonder if she even read any of it? If I wanted to know what the callers to the NZ immunization hotline were talking about, she’d be the first person I would listen to. Don’t you find it ironic, she complains about Dr. Lee’s conflict of interest, and then never bothers to declare her own? That’s a hoist by her own petard if I ever saw one.

But back to the point: Without referencing any of Dr Lee’s published work, how do you figure her commentary pertains to this case report (especially since it was published 2012/09/24)? It sure looks like you’ve moved from dupe to troll and back to dupe on this one. Of course, if you really think it’s pertinent, why don’t you cut and paste the relevant section here for discussion? Here’s a guess: You have no idea which section if any applies right? I won’t hold my breath.

@bimler “No-one — here or in the literature — has offered any scientifically plausible source for a purported non-B DNA, or indeed any evidence that a non-B DNA conformation was present.”
You’re right because Dr Lee isn’t here. However, he did demonstrate it in the report. As I pointed out in post #413, the HPV-16 L1 DNA can’t be amplified by a set of degenerate consensus GP6/MY11 primers, but requires a set of non-degenerate GP6/MY11(1) primers to amplify, and therefore it is considered in non-B conformation by definition. The same thing applies to the DNA found in Gardasil described in the J Inorg Chem paper. To help you understand the basics of non-B conformations, I’ll post 3 references in other comments #449-451 (too many links triggers moderation). AdamG’s reference dealt with in vivo non-B conformations which are numerous and there is nothing unique about them. That paper indicates that DNA can adopt some non-B conformations without mutagenesis in DNA sequence. Dr Lee reported that similar phenomena may be observed in vitro when HPV DNA binds to AAHS in Gardasil. This was demonstrated by PCR with different primer sets while there is no change in the base sequences of the DNA. i.e. A change in the DNA characteristics without mutagenesis in DNA sequences is the basic definition of adopting non-B conformations.

@bimler “A hundred or so comments later, Mr Pink belatedly accepts that Lee is not an accepted authority because no-one else is using his methods:”
Nice strawman. Apparently, even you can’t discern that he used an existing PCR methodology to research something unique (HPV-16 L1 DNA fragments in non-B conformation). New research topics do not require new methodology. I already published a reference showing others using the same methodology to genotype HPV DNA. The stupidity of your strawman is astounding. You probably missed the link I posted in #413 which shows Dr Lee’s methodology paper on HPV DNA genotyping is the all time top download at Infectious Agents and Cancer. 16.5 thousand accesses indicate quite a bit of interest in someone you claim is not an accepted authority.

@Narad “I take it that you mean the “unique” conformation that hasn’t been demonstrated.”
Ah, but it has. Of course, given that you couldn’t even differentiate the basics like the methodology from the technology, it’s no surprise you didn’t understand it.

@Narad “Not a forward, unpublished one, and certainly not one that one has purchased from the same vendor.”
If it’s the same publisher, the reviewers have full access to both reports.

@Narad “I take it that you mean the “unique” conformation that hasn’t been demonstrated.”
No, you just don’t understand either. It’s in non-B conformation by definition based on the results of the PCR. See my response #413 or #454 to bimler. Further illustration of your lack of understanding: there is no unique non-B conformation in DNA structures. What is unique, is finding HPV-16 L1 DNA in a non-B conformation both in the vaccine and in the autopsy tissues.

If it’s the same publisher, the reviewers have full access to both reports.

Not even wrong, Pink.

Mr Pink, it bears repeating that no-one has shown HPV DNA occurring in a non-B conformation in patients.

The fact that a PCR failed does not constitute evidence that DNA is in the non-B conformation.

the finding of HPV DNA in non-B conformation in human tissue alone is unusual and significant.

There is probably little point in noting that no-one is testing for “HPV DNA in non-B conformation in human tissue”, so the confident claim that the hypothetical finding thereof “is unusual and significant”, is “not even wrong”.

Has anyone taken a close look at the gels in the ABB article? Figure 8 is just honking with weird artifacts, there are obvious blobs of contrast adjustment in Figs. 1, 3, and 9, but I’m not familiar enough with stuff to tell how normal the processing is, nor to identify reuse or inversion of bands.

Sorry, too busy enjoying this new technique of “science -by-definition” —

It’s in non-B conformation by definition based on the results of the PCR

— in which the absence of detectable, reactive DNA is simply defined as the presence of unreactive DNA.
How I regret all that time wasted on experiments when I could have simply re-defined the failures as successes. I think I shall define myself a Nobel Prize now.

Mr Pink,

You assume no-one here knows anything, and that you’re ever so vastly superior, when your opening gambit was to make a fool of yourself with a ridiculous claim that Lee was “The scientist who has basically written the book on high sensitivity PCR testing and published many peer reviewed papers”? Both claims were badly wrong in a way only those with no understanding or experience of research science would make, yet having been demonstrated they are wrong you have proceed to bluff and bluster even more.

Perhaps you don’t “get” that bluff and bluster like yours only works if the others know as little of the science as you do?

What is impressive, though, is the extent you want to play your game of bluff and bluster, which is why I asked back at comment #312 why you’re doing this: “What might be more interesting is to know why he’s bothering with this act. Is he a SaneVax devotee (or employee), for example.”

You have the troll’s habit wanting to dismiss everyone whose opinions differ to yours out-of-hand. The childish nature of them is, well, childish and only shows you’re not really interested in the science just in bluff, bluster (and trolling).

You also have the troll’s habit of steadfastly ignoring the larger issues to burrow into and twist specifics as if somehow they’re important when the larger picture is already wrong. Read my comment #36, written well before you wrote on this thread. (Lee’s speculation of non B-form DNA is curious for the logic he’s using, as h.d.bimler has pointed out, but Lee’s work has larger problems.)

“how your writing of a textbook chapter demonstrates a lack of expertise?”

Not what I wrote. Putting words in other’s mouths is just trolling. (Or simply not reading what people have written. Or possibly an even deeper lack of understanding of research science than I thought.)

Getting back to the IMAC aticle –

You focus on attacking the person (the author) not addressing what was presented in the report. Just like your repeated slurs of people here it’s very telling and shows you’ve no sincere intentions and suggests you aren’t able to deal with the claims in the IMAC presentation. In other words: you’re at bluff and bluster, again.

The author of the IMAC report has a wider background than you are making out and is familiar with the area Shaw works in (which you seem to have “overlooked”). Your reply shows that you don’t understand how IMAC works (or research science works, for that matter). They draw on expertise throughout New Zealand, not just the author’s own research.

Let fill in something you don’t appear to understand (which also happens to shows you lack understanding of this whole case). Lee at the time of the coroner’s inquest had not published the method presented at the coroner’s inquest. The publication examined in Orac’s post (above) came out well after the inquest. The author of the IMAC report cited what was available at the time – reference to Lee’s work made by SaneVax.

The lack of research publication at the time of the inquest actually part of the reason why Lee and his work is, in my opinion, inappropriate for a coroner’s inquest regardless of what it concludes. Medical examinations need well-established procedures that have been tested, well understood and are widely accepted – not speculation hanging off techniques that have yet to be established as sound by the scientific community. Lee’s publication after the fact doesn’t make it sound – the journal it’s published is, to be polite, “dodgy”.

What might make it sound is acceptance by other scientists and independent confirmations that it works, but that hasn’t happened. It still hasn’t be confirmed as sound but has drawn criticism, as the IMAC reported noted and cited (see last reference). It not surprising it’s being criticised as never minding issues about the protocol several of his statements needed to stretch his “findings” to be relevant to the case are, at best, speculation. (See also my comment #36. Even the title Lee has given his own article indicates he can’t show the DNA is from the vaccine – which you don’t seem to “get”.)

“Don’t you find it ironic, she complains about Dr. Lee’s conflict of interest, and then never bothers to declare her own?”

But you don’t name any. Interesting you’re using one of the truly tired old anti-vax lines, though.

“But back to the point: Without referencing any of Dr Lee’s published work, how do you figure her commentary pertains to this case report (especially since it was published 2012/09/24)?”

Did you even read my comment before making that silly statement?

“It sure looks like you’ve moved from dupe to troll and back to dupe on this one.”

Nope: see my previous remark – you messed up. Try reading what people have written.

”Of course, if you really think it’s pertinent, why don’t you cut and paste the relevant section here for discussion? Here’s a guess: You have no idea which section if any applies right? I won’t hold my breath.”

There you go trying to make out that no-one here knows anything again. You know that old saw about making assumptions…? (You’ve the ass in assume here.)

Suggesting I need to learn about non B-form DNA is a laugh.

(BTW, your “background references” show you don’t know what you talking about again. You don’t seem to “get” that your bluff and bluster routine only works on people who are equally unfamiliar with science as yourself. For anyone who knows molecular biology, you look silly.)

Mr. Pink,

I’m guessing you don’t study HPV infections or cervical cancer because the finding of HPV DNA in non-B conformation in human tissue alone is unusual and significant.

You are correct, my area of expertise is clinical biochemistry and I am only slightly familiar with PCR, but I believe the same general principles I am familiar with apply in virology. If Lee’s method of detecting HPV DNA in non-B conformation had been replicated and was accepted as accurate and reliable by the scientific community I would agree with you, but according to others here with greater familiarity with this area than myself, this does not appear to be the case.

How can we be certain that Lee has detected vaccine-derived HPV DNA in non-B conformation at all? For example, is the DNA sequence in question unique to HPV? If so, is it unique to vaccine-derived HPV? Could the sample he examined have been contaminated somehow? Normal controls would go a long way towards clarifying this.

If someone detected plasmodium malariae in the blood of a native Eskimo living near the North pole, would it need a population control study to show the finding is unusual and significant?

Malaria is generally identified by direct observation through a microscope, but assuming an indirect technique such as PCR was used to identify plasmodium malariae DNA, my first suspicion would be that this is a false positive, and I would try to eliminate possible causes, which might well include running blood samples from other Inuit to see if I obtained a similar result. I certainly wouldn’t publish a paper claiming that my Inuit subject had been infected with malaria by a vaccine without vigorously ruling out every other possibility.

Somewhat related to the current discussion is this first comment in reply to the ArsTechnica take on the story h.d.bimler pointed out:

“In other news, my Journal of How that Bastard Todd Owes Me $100 just published its first study, titled “How That Bastard Todd Owes Me $100”, which conclusively proves that that bastard Todd owes me $100.”

(Point being that just because someone published a paper on something doesn’t in itself make it right.)

If someone detected plasmodium malariae in the blood of a native Eskimo living near the North pole, would it need a population control study to show the finding is unusual and significant?

The analogy becomes more exact if the Someone reporting plasmodium is using his own patented Lo-Temp test, which he has never validated against people known to have malaria; nor with negative controls from people known not to have malaria. In fact his only basis for describing it as sensitive to plasmodium is that it is not a test for tuberculosis — it gives a positive signal for blood samples where standard tests for mycobacteria show nothing.

I think this researcher will not be working for the Copenhagen School of Global Health.

Melissa G,

I confess I even checked if the Journal of How that Bastard Todd Owes Me $100 existed in case someone had created it for laughs. (Or out of spite.)

@grant “You assume no-one here…”

Grant, you don’t need to foam at the mouth because I didn’t assume anything about you at all. My comments about you are based on empirical evidence: the ridiculous arguments you’ve posted in this discussion. That’s called an evidence based approach. The observations have even been repeated, so maybe I’ll call it a science based approach.

@grant “Both claims were badly wrong in a way only those with no understanding or experience of research science would make, yet having been demonstrated they are wrong you have proceed to bluff and bluster even more.”

You come here and say: “you don’t know this”, “you don’t know that” and yet you produce not a single concrete argument about the paper itself. The funniest of all is “what are your motives” as if that was revelent to anything but a murder trial. The arguments you did present (“you’re a troll”, making you the dupe, or “Hell, I’ve written a chapter in a Springer book” (post #300) and therefore it doesn’t denote expertise) are incomprehensible. You go and post a “commentary” and claim it is an “examination” of Dr Lee’s work when it doesn’t even reference a single one of his many papers on the topic. You also said you had so many better things to do when it came time to pony up on the arguments, but then here you are again. If anyone is trolling, it sure seems like it’s you. So what are you: the troll, the dupe, the liar, or the clown? How about all of the above?

Oh, and since you were away so long, did you notice that Dr Lee’s methodology paper on HPV genotyping was the top accessed article with 16,000+ accesses in Infectious Agents and Cancer (link on post #413)? Maybe you should argue about Dr Lee’s credibility and expertise with that journal and all those people who downloaded the article?

@Grant “…you focus on attacking the person…”

That’s a strawman because my focus was on the fact that the publication was represented by you as an “examination” of Dr Lee’s work and yet, the author documented it as a “commentary” of a hearing. Even worse, not a single one of Dr Lee’s published papers was referenced despite the paper about the Gardasil findings being published prior the commentary. Who publishes an “official” scientific analysis document with the file name at the bottom and no official publication date? You were complaining in the same breath about “dodgy” peer reviewed journals and you want someone to take that stuff seriously? There should be a major case of cognitive dissonance going on down under right about now. Any way you look at it, it’s a clear misrepresentation on your part. As for COI, I’m beginning to doubt you know your NZ vaccine literature, because IMAC has published many pretty flyers, nice and clearly marked as sponsored by Merck (I’m sure you can figure out how to google them).

All of that is irrevelent though — except maybe as evidence of your total lack of judgement. The paper does not reference the case report we are discussing (since the commentary was published first), and doesn’t even reference any of Dr. Lee’s body of published work (available to the author). Consequently, it really is tangential to the discussion here especially since Dr Lee has published two papers on this matter with a third “in press”. Continually going on a tangent is a tactic in the trolling handbook. Wasn’t it you who first starting throwing out the trolling accusations? More irony for you.

@Grant “There you go trying to make out that no-one here knows anything again. You know that old saw about making assumptions…?”

Good thing I didn’t make an assumption. It was clearly qualified as a guess in your own quotation. Your reading comprehension really needs some work and perhaps that explains a lot of things here. Of course, after erroneously accusing me of making an assumption, you provide ample evidence to validate my guess in spades by not posting a single relevant section from your non-dated “expert commentary” here to discuss. Let me guess again: some more stupid hippie parents down under were urgently calling and you have to run off and go tend to more important things right? Good thing I didn’t hold my breath.

@Krebiozen “… had been replicated”

The case report was published on December 27, 2012. Expecting a published replication of the results is unrealistic at this time. Assuming the results are wrong based on a lack of reproduction, or the fact that one doesn’t like the findings is illogical.

@Krebiozen “How can we be certain that Lee has detected…”

Did you read the case report and the comments here as all of your questions were answered and discussed?

@Krebiozen “…according to others here with greater familiarity…

I am curious how you managed to judge “great familiarity” of the posters with HPV genotyping or conformational changes of DNA based on blog posts? This is especially puzzling when the majority of the posters here have demonstrated difficulty comprehending the difference between the methodology used and the PCR technology after reading the report. There have been many claims of “familiarity”, but the comments indicate otherwise in most cases.

@Krebiozen “…in non-B conformation at all?”

Answered in post #454. The evidence of HPV-16 L1 DNA fragments in non-B conformation was articulated several times prior and the relevant sections of the case report were quoted. As for certainty, I suggest that medical science is not the field for you, if that’s what you want. If you want validation, all the data and methods used are contained in the report and you can get someone to replicate the experiment.

@Krebiozen “For example is the DNA sequence in question unique to HPV?”

Yes, and this was already answered numerous times in previous posts.

@Krebiozen “If so, is it unique to vaccine-derived HPV?”

As documented in the report and discussed above, the sequence of the HPV-16 L1 DNA fragment identified in the autopsy tissues was not unique to the vaccine. But a non-B conformation of the HPV-16 L1 DNA fragment, as described in the paper, has only ever been found in the Gardasil vaccine and the post-mortem samples.

@Krebiozen “Could the sample he examined have been contaminated somehow”

The methods of sample collection were described in the case report. Controlling for lab contamination is standard practice in professional laboratories. You should know that there is no way to prove definitively to you that lab contamination didn’t occur. However, the methods are clearly described and you or anyone else can replicate the experiment if one doubts the professional quality of the lab work. Given that the only other identification of HPV DNA fragments in non-B conformation came from the Gardasil vaccine, it’s hard to imagine how the autopsy tissues would have been contaminated in either tissue collection or in the lab.

@Krebiozen “Normal controls would go a long way towards clarifying this.”

I’m not sure what you mean by “normal” controls. If you are referring to population controls as proposed by others, these would not help you identify lab contamination. Population controls would help you determine if HPV DNA fragments in non-B conformation — which have never been seen before despite huge amounts of research into HPV — are somehow prevalent in the general population.

@Krebiozen “I certainly wouldn’t publish a paper claiming that my Inuit subject had been infected with malaria by a vaccine without vigorously ruling out every other possibility.”

Assuming you are a professional, followed professional lab practices, and had validated the results of your testing you would be justified in doing so because of the unique nature of the findings. You wouldn’t have to do a population study prior to publishing a case report and just like Dr. Lee suggested in his case report, you would recommend more extensive follow-up study be done.

@Narad “The fact that a PCR failed does not constitute evidence that DNA is in the non-B conformation.”

It does. We know it is an HPV DNA fragment because as documented in the case report, Dr Lee was able to sequence an amplicon matching HPV-16 L1 DNA. We know it was in non-B conformation, because the degenerate consensus GP6/MY11 nested PCR primers which were designed (not by Dr. Lee) specifically to amplify all clinically relevant HPV L1 Gene DNAs do not generate an HPV amplicon. Because the DNA lacks a binding site for a standard degenerate HPV primer, it indicates that the HPV DNA fragment has acquired some form of topological conformational change (i.e. non-B conformation by definition) even though the sequence has not changed. This part isn’t that complicated.

@bimler “– in which the absence of detectable, reactive DNA is simply defined as the presence of unreactive DNA.”

Are you sure? How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

@bimler “The analogy becomes more exact if the Someone reporting plasmodium is using his own patented Lo-Temp test, which he has never validated against people known to have malaria;”
Earth to bimler: LoTemp is a trademark for “a low temperature (LoTemp) PCR catalyzed by a highly processive DNA polymerase with proofreading function” ( Have you read the paper?), not a patented test. Read comment #405 again. The HiFi polymerase used in the LoTemp PCR has been validated and shown to be more effective in amplifying HPV-16 DNA than Takara Taq (“Routine human papillomavirus genotyping by DNA sequencing in community hospital laboratories.” Infect Agent Cancer 2007; 2:11) . The case report being discussed also shows positive controls which invalidates your statement above. That’s a major analogy fail at the most basic level.

@Narad “The fact that a PCR failed does not constitute evidence that DNA is in the non-B conformation.”

Do try to get your attributions straight, Mr. Details. I’m the one simply pointing out that Lee has been reduced to the absolute bottom of the publishing barrel, something that you demonstrably have no understanding of whatever.

@Mr Pink

Oh, and since you were away so long, did you notice that Dr Lee’s methodology paper on HPV genotyping was the top accessed article with 16,000+ accesses in Infectious Agents and Cancer (link on post #413)?

Are you seriously using argument from popularity now?

Can someone explain to me in simple language why a degenerate primer would pick up non-B conformation DNA of known sequence when a non-degenerate primer does not? Perhaps it’s the virus I currently have that’s making my brain more befuddled than usual, but I have read and reread Lee’s paper, Orac’s post and Mr. Pink’s comments and I still don’t get it.

Mr Pink,

“Grant, you don’t need to foam at the mouth” – straw-man & trolling.

You realise that in opening everything you write with this sort of childish stuff you are telling readers that the rest of what you write is not worth reading, likely to make no real sense and that, as I pointed out earlier, it shows you have no sincere interest in the issue at hand.

If you do this sort of thing people don’t actually have to deal with the points you raise, they can simply point out that you’re being insincere and leave it at that. After all, people don’t have to respond to your “demands” that they present evidence anyway (they can just prefer to do something else) and doubly so if you make silly accusations and so on.

I think It’s telling that you have tried to dismiss the IMAC document (out-of-hand) by attacking it with anything but what it says about Lee (and Shaw), including some incredibly twisting of what I wrote. You’ve also avoiding that Lee’s work has bigger problems than this non-B-DNA and other “details” you keep trying to burrow into. (See comment #36.)

In summary, and to borrow from Orac, your comment is “a massive load of fetid dingo’s kidneys”: the claims you’re made about me are (wildly) incorrect. Common elements seem to be simply not reading what I wrote, putting words I’ve never said into my mouth, twisting word meanings or lifting them out of context, and so on. (Also: in your comment you have me both presenting arguments and presenting none.) It leaves me well justified in describing your behaviour as trolling.

You got shown up for trying to make out Lee has having written “the book” on the subject. You claimed, and are still trying to claim, he has an impressive publication record when he doesn’t. (I pointed to how short his publication list is earlier.) You made an error no-one who knows research science would make about book chapters, then went on to repeatedly bluff and bluster about the paper.

Quickly, then, just a few of the points – I’ll ignore all the silly twisting of my words, but one word on that before I go on: attacking others doesn’t make you or Lee right.

“are incomprehensible” – Incomprehensible to you – which was my very point, one you’re re-enforcing: your lack of understanding it is showing that you don’t understand research science. Either that or you are offering straight-out bluster.

(It really is very simple: book reviews are rarely peer-reviewed the same way that papers are, so they’re “softer” in that sense. That I’ve had to spell this out to you says you simply don’t know how the scientific literature works – as anyone who works in research science will.)

with 16,000+ accesses – So? That doesn’t make the paper good. It can simply mean it’s been linked to on social media, blogs, etc. (Heck, if anyone wanted to it’d be easy enough to write a Perl/Python/etc script to repeatedly download the paper to rig the count.) What your pushing this does illustrate, though, is the extent that you’re trying to prop up this piece of work by any means you think you can. Naturally, that raises the question of why you’re doing it.

“The paper does not reference the case report we are discussing” – I explained this carefully to you in my previous comment to you. Why are you now offering this as if it I had not explained this to you and that you clearly didn’t understand that earlier, which lead me to explaining it to you? The IMAC document is relevant: all of this discussion relates to the coroner’s inquiry (as Orac said). An earlier look at the work Lee and Shaw’s work (presented at the hearing) is not suddenly invalid or irrelevant because of Lee’s more recent publications.

“doesn’t even reference any of Dr. Lee’s body of published work “ What don’t you understand here? If Lee had not published work related to what he presented at the inquiry at that time, there would be nothing to cite would there? (Go back and re-read my comment.) Think about it. It would mean that Lee could not cite any work at the inquiry either. Dressing up Lee’s publications up as a “body of published work” is puffery: as I pointed out quite a while back he has a tiny number of papers – you’re doing your bluff and bluster number again.

@Krebiozen

“Can someone explain to me in simple language why a degenerate primer would pick up non-B conformation DNA of known sequence when a non-degenerate primer does not?”

Just running from your lead (haven’t time to pick up where you’ve got this from in the paper):

All other things being equal the results for the the non-degenerate primer work should be a subset of that using the degenerate primers. (I’m assuming that the degeneracy includes representing the non-degenerate sequence.) If so, you might expect:

– both results positive (two tests showing same outcome; PCR may have found something, if controls, etc. support are favourable)
– neither result positive (didn’t find anything or protocol no good)
– degenerate primers showing positive results, but non-degenerate primers negative (possibility that there is an HPV sequence, but not one like the non-degenerate primer targets; you’d also have to control for error, contamination)

The one you don’t expect is non-degenerate primers giving positive results and degenerative primers negative results as in this case the degenerate results ought be positive. That would suggest a problem. In this situation the non-degenerate primer should be effectively acting as an independent confirmation of what the degenerate primer finds except that results conflict, raising questions/doubts.

As for non-B conformation DNA to explain these results this argument would have to be applied unevenly – to one and not the other. To resolve that you’d have to add more speculation to the unsubstantiated claim that the failure of the primers is due to the DNA conformation.

As for how it might happen, I think it’s more useful to keep the larger picture in mind. Lee hasn’t shown that this failure of the primer is due to non-B conformation DNA to start with.

e.g. from the paper,

“These variances in PCR amplification characteristics indicate that there are topological conformational changes in the HPV-16 L1 gene DNA fragments in the postmortem samples.”

is faulty logic. He’s skipped a beat. (Several beats really.) All he can say is “one PCR reaction approach failed”. He can’t say why it failed without demonstrating this, but he doesn’t do that.

Likewise, going on to draw an association with tests on Gardasil is to draw an overly long bow – speculation again.

To top off not showing these, the reference to support these is “in press”, which has him presenting conclusions ahead of the evidence. (Furthermore, the title suggests he’s assuming aluminium is involved in this DNA conformation, but he hasn’t shown that either.) This means for the current paper these statements are empty, unsubstantiated. It strikes me that Lee’s paper is left “special pleading” in that it’s asking for it’s results to be accepted based on work not yet shown with the up-shot that little (possibly nothing) can be concluded from the paper itself.

From the point of view of the inquiry it doesn’t really matter what Lee’s results are. (See also comment #36.)

Lee’s work hasn’t been verified – as Mr Pink indicated in his reply to you. Unverified science, stuff still under question is—in my opinion—not useful or suitable for a medical/coroner’s investigation regardless of if you accept the claims or not. The work cannot be used to offer resolution of an issue as the work itself is still under question.

Grant’s “The work cannot be used to offer resolution of an issue as the work itself is still under question.” is the perfect encapsulation of the circular reasoning at work in Dr. Sin Hang Lee’s work, and in the verbiage of his apologists. Well done, sir!

@flip “Are you seriously using argument from popularity now?”

I didn’t expect you to be following so too closely. Starting in post #300, Grant was questioning Dr Lee’s expertise. I know that a ways back, but Grant ran off (claiming to be busy) when asked to articulate something about the case report. Do you have any real questions about the case report yet or are you going to be content to sit on the sidelines and troll at the edge?

@LW “16,000+ accesses: Orac’s fans checking it out?”

LOL. Certainly, Orac’s groupies have been known to crash online polls, but this seems a little counter to their objectives. Not surprisingly, Grant acknowledges expertise in the area of generating fraudulant statistics. Perhaps he inflated the stats.

@Narad “Do try to get your attributions straight, Mr. Details. “

Apologies Narad, it should have been attributed to ChrisP.

@Grant “You realize that in opening…”

You shout TROLL, TROLL, TROLL, and then you come back, again, and again, and again. That makes you a dupe by definition. I can’t understand how you will ever win that argument especially since at post #478 it’s you who won’t discuss the case report?

@Grant “If you do this sort of thing people don’t actually have to deal with the points you raise, they can simply point out that you’re being insincere and leave it at that.”

You write the words but simply don’t get it. Please, make a logical argument about the paper. You have attacked the author, the journal, the commenter, my motives etc, but as of post 478 you have yet to address a single point about the paper itself. By your own definition, you categorically meet the definition of insincere.

@Grant “… tried to dismiss teh IMAC document…”

At least you’re not calling it an “examination” anymore and it wasn’t a twist of words to call you out for misrepresentation. I notice your “expert” document writer didn’t even bother showing up for the coronial investigation? With all that “expertise” and all those important points to make, you would think she would have been chomping at the bit to participate on the record. Your vaunted “expert” was probably too busy to show up to the investigation because she’s busy writing studies about wait times on health hotlines. I’ll bet she was so busy she also forgot to take the filename off her PDF and actually provide people with a publication date too right?

I asked you again to quote the segment of the document you thought applied to the case report being discussed. No quote, no pertinent section, just some rambling excuse. I’m ignoring the document not because I casually dismissed it but because you have failed to show its relevance.

@Grant “All other things being equal the results for the non-degenerate primer work should be a subset of that using the degenerate primers. (I’m assuming that the degeneracy includes representing the non-degenerate sequence.)”

Wow, after 479 posts, you actually talked about some science. You predicated your answer on the two erroneous assumptions above. In the non-degenerate work, there are two primers — namely one pair — in the PCR mixture. In the degenerate primer work, there are nine primers — numerous pairs — at variable concentrations in the PCR mixture. Each individual nucleotide in a degenerate primer may have different concentrations from the rest. They may also compete for the same binding site in some cases. To assume the result of non-degenerate primer PCR must be a subset of the results of degenerate primer PCR is childish. If you actually read the case report, you should also have noticed in section 2.5 that the degeneracy does not include an HPV16MY11+ primer. Perhaps you know how to model genes on a computer, but your brutal assumptions about the methodology indicate it is highly unlikely that you’ve ever had to find target HPV DNA mixed with human genomic DNA or that you understood the basics of the paper. Since your assumptions are totally wrong, that renders the rest of your discussion rubbish and your own logic is highly suspect.

@Grant “Unverified science, stuff still under question is—in my opinion—not useful or suitable for a medical/coroner’s investigation regardless of if you accept the claims or not.”

Also rubbish. Your portrayal of nested PCR test results as “unverified science” is bogus. The science is based on well established methodologies and the judge can ask for its reproduction if he so desires. Given that the ME could not determine a cause of death, the court should gather the best available information especially from test results that might lead to an explanation of death. Since the ME is on the record making some pathetic excuses about external factors in NZ that “militate against good clinical practice”, your high pitched whine about expert testimony with real test results is a farse. Even if the test results are not definitive, they can provide good information for the coroner to make recommendations in the interests of public health which is one of the objectives of an investigation.

As I noted earlier, maybe you can explain why your touted IMAC “experts” were completely absent from the hearings? Despite your pleadings that they are certain Dr Lee is wrong in his methodology, and testing, they brought nothing to the table and that is on the record. Pathetic.

@Antaeus Feldspar “I am in awe of your patience, Grant.”

I am in awe as well, but it wasn’t patience that came to mind…

The logical argument about the paper has been made multiple times now: it presents no evidence demonstrating the sequences he amplified were of vaccine origin.

Certainly, Orac’s groupies have been known to crash online polls

Please provide an example.

“Certainly, Orac’s groupies have been known to crash online polls”

Yes, I did “crash” an online poll…conducted by an anti-vaccine group which *attempted* to show health outcomes for kids whose parents “opted out of vaccines”-vs-kids who received complete and timely childhood immunizations.

Perhaps, *Pink* would like to provide us with information about the validity of “online polls”…which are not even listed here on the hierarchy of research methods.

http://www.healthknowledge.org.uk/public-health-textbook/research-methods/1a-epidemiology/hierarchy-research-evidence

*I’m smelling dirty socks here.

@Narad “Please provide an example.”

Please do your own homework.

@lilady “Perhaps, *Pink* would like to provide us with information about the validity of “online polls”…which are not even listed here on the hierarchy of research methods.”

I never referenced any online polls as research evidence. Those are your words sweetie. But thanks for holding the groupie poll crasher flag high because Narad either hasn’t been around here long or has a defective memory.

@JGC “The logical argument about the paper has been made multiple times now: it presents no evidence demonstrating the sequences he amplified were of vaccine origin.”

I am sorry you don’t understand the science. Read post #441, second point. It’s a unique finding. I’m still waiting for a single plausible scientific explanation for how the HPV-16 L1 DNA fragment in non-B conformation ended up in the tissue samples or how it could possibly be prevalent in the general population with no one noticing until now. Apparently, none of the smart guys here can come up with any explanations.

You have attacked the author, the journal, the commenter, my motives etc

Are you or are you not willing to admit that SCIRP is the bottom of the barrel?

@Narad “Please provide an example.”

Please do your own homework.

I will take that as a concession that you cannot defend your assertion.

You have attacked the author, the journal, the commenter, my motives etc

Kids these days have no idea of how to attack motives. One has to go back to September 2011 to see a “MrPink ” demonstrate how to the job properly, in a classic of the genre.

@ Pink (Sweetie): At least I owned up to crashing a bogus internet poll right here on Respectful Insolence.

Where is Dr. Lee’s research published, on locating rDNA HPV vaccine virus and his Lyme disease serum PCR test?

How’s Dr. Lee’s lawsuit against Milford Hospital which fired him because he was running those tests, as a “side business”, when he was employed in their pathology lab, coming along?

I’m still smelling dirty socks, Pink.

@ herr doktor bimler: You’re right. Kids today have no idea how to attack motives…but we did a good job of handling Pink/Sweetie, back then.

It’s been more than a year since Dr. Lee was given the boot and he still has not returned to his job at Milford Hospital.

@Mr Pink

@flip “Are you seriously using argument from popularity now?”

I didn’t expect you to be following so too closely. Starting in post #300, Grant was questioning Dr Lee’s expertise. I know that a ways back, but Grant ran off (claiming to be busy) when asked to articulate something about the case report. Do you have any real questions about the case report yet or are you going to be content to sit on the sidelines and troll at the edge?

Perfectly happy to troll at the edge, given you’ve just non-sequitured your way around answering the question. Or admitting you just used a logical fallacy. Do you have any real answers about your arguments for the case report yet or are you going to be content to be patronising?

Counting the number of times people download a paper or visit a website doesn’t suddenly turn that paper/website into verified information. If that were true then the Time Cube website would be accurate simply based on the number of people who have visited it out of curiousity. Naming the number of views/downloads is not a valid reason to say that the paper is itself valid. A primary school graduate would figure that out.

This reply to me really does confirm that you seem intent on reversing the scientific process: someone must disprove the paper, rather than prove the hypothesis contained within.

@HDB

Thanks for that old thread. I had forgotten about it.

@Mr Pink:

@LW “16,000+ accesses: Orac’s fans checking it out?”

LOL. Certainly, Orac’s groupies have been known to crash online polls, but this seems a little counter to their objectives. Not surprisingly, Grant acknowledges expertise in the area of generating fraudulant statistics. Perhaps he inflated the stats.

Wait, what?

How did the number of accesses turn into a poll? How does curiosity by a lot of people turn into an attempt to “crash a poll”?

And 16K was your number that you brought up for your purposes. What does Grant have to do with your number? Are you saying that you brought it up but you think it may be fraudulent?

Gee, Mr Pink.

My polite corrections and pointing out your errors must getting under your skin: you’re trying so hard to make me out to have said and done things I haven’t.

Things like “Not surprisingly, Grant acknowledges expertise in the area of generating fraudulant statistics. Perhaps he inflated the stats.” are just silly. (FWIW: I was actually thinking it’d be easy enough for a SaneVax supporter or member to rig the stats – there’s no good reason I would want to is there?)

I one can live with that one of course — it’s just silly, after all — but some of the others are obvious attempts to smear or discredit me. Childish stuff that says a lot about you in my opinion.

Repeatedly making claims about me that I simply have not said or done, twisting lifting my words out of context, smearing me, etc., will not make you or Lee right.

More of this was covered in comment #478.

I’ll choose to ignore them as the claims you have made of me are really just too silly to bother counter. (At some points you’re even re-introducing things that have already been dealt with.)

Just to correct a few minor points (ignoring the silly attempts to smear me):

“Even if the test results are not definitive, they can provide good information” — leaving aside the apparent contradiction in this, I didn’t say “not definitive”, I said the particular methods hadn’t been independently verified – as you said as much yourself.

“Your portrayal of nested PCR test results as “unverified science” is bogus.” — What you say here is bogus 😉 I did not say “nested PCR test results” were unverified science. I said the body of work in the paper, all of it taken together, has not been verified — which you said as much yourself, as I pointed out at the time. This, your words: ” Expecting a published replication of the results is unrealistic at this time.” — you clearly accept that it has not been independently verified (replicated) yourself. It seems not only do you need to read my words accurately, you need to read your own too.

“Orac’s groupies have been known to crash online polls, but this seems a little counter to their objectives” — this seems all over the place. Reading a paper is not crashing a poll and reading the paper would be entirely in anyone’s objectives if they were checking what it said. It’s also possible, if not probable, that the high count is, in part, due to SaneVax groupies and others they have promoted this work to 😉 (Lee’s paper and the work in it were paid for by SaneVax — as noted in the paper — and SaneVax has been busy touting it through press releases and whatnot, as a quick google search will verify.)

Mr. Pink at 487

Re: non-B conformer, thank you for pointing out a second logical error that’s been pointed out to you, but you prefer to ignore. In addition to not offering evidence the DNA amplifeied was vaccine in origin, Lee also offers no evidence that the DNA is present in a non-B conformer: this is simply an assertion on his part (see Herr Bimler’s posst at 351 and 445, AdamG’s at 384, 390 and 411, Grant’s posts at 480, etc.)

It’s not that no one’s pointed out the paper’s logical failings, but that you either do not understand why they’re failings or prefer to ignore them.

@Narad “Are you or are you not willing to admit that SCIRP is the bottom of the barrel?”

Are you or are you not willing to admit that the journal of publication has no bearing on the content or quality of any specific paper?

@Narad “I will take that as a concession that you cannot defend your assertion.”

Bad assumption. Read post #486. Lilady did your homework for you.

@bimler “One has to go back to September 2011 to see a “MrPink ” demonstrate how to the job properly”

Congrats bimler. Almost a month and a hundred forty odd posts later, you finally found the OP goalpost shifting I alluded to earlier. You guys are really slow since I thought my original hint was pretty obvious.

@lilady “Where is Dr. Lee’s research published, on locating rDNA HPV vaccine virus and his Lyme disease serum PCR test?”

Earth to lilady: I know you love to go off on tangents but, the case report is about HPV testing, not Lyme disease. I already posted a reference to a published report about the PCR technology and it’s efficacy in HPV genotype testing. Try to keep up.

@flip “Or admitting you just used a logical fallacy.”

No flip, an argument of popularity requires 2 parts: an argument, and an example of popularity as evidence or justification. If you read what you quoted carefully, there was no argument and only a fact was stated. It seems you’re so fond of fallacies you posted one big juicy strawman.

@LW “How did the number of accesses turn into a poll?”

It’s called sarcasm. Read post #478 and if you still don’t understand, ask the computer guy Grant to explain it to you. Apparently, he has a lot of patience and in #478 explains how to use computers to generate fraudulant statistics on the internet.

@grant “… you’re trying so hard to make me out to have said and done things I haven’t. Things like “Not surprisingly, Grant acknowledges expertise in the area of generating fraudulant statistics. Perhaps he inflated the stats.” are just silly. (FWIW: I was actually thinking it’d be easy enough for a SaneVax supporter or member to rig the stats – there’s no good reason I would want to is there?)”

A strawman. Right before your quote I stated it was counter to your objectives, and I merely pointed out you had expertise in the methods because in post #478, you outlined a computational method to fraudulantly inflate the statistics. I didn’t misrepresent you at all. As for silly, I think making me out to be a troll while playing the dupe ranks pretty high up there on the silly and stupid list.

@grant “Repeatedly making claims about me that I simply have not said or done, twisting lifting my words out of context, smearing me, etc., will not make you or Lee right.”

The only example you gave above was a strawman, and that leaves you with an evidence free argument. When my kids do that, I call it whining.

@grant “I didn’t say “not definitive”, I said the particular methods hadn’t been independently verified – as you said as much yourself.”

Two strawman arguments in there. I never said the methods hadn’t been verified. I said the results had not been replicated (verified). From post #471, “Expecting a published replication of the results is unrealistic at this time.” The methodology of using nested PCR for HPV genotyping is not a new methodology which you and a few others just can’t seem to get through your heads. If you can’t understand the difference between methods and results, one should really question your science pedigree.

The second strawman is that I never made the claim you said “not definitive”. My point was that non-definitive evidence — of causation since we’re talking about a coronial investigation — from test results (whether they have been verified or not) are completely relevant to a coronial investigation.

@grant “I said the body of work in the paper, all of it taken together, has not been verified”

No Grant, this is what you said: ” Unverified science — stuff still under question is — …”. Since nested PCR is a standard testing methodology for HPV genotyping, your use of the term “unverified science” must refer to the findings of the tests. That is non sequitur because by that same logic, the Tox tests the ME ran (only once through one lab and therefore not validated) would also be considered “unverified science” and should be inadmissable. I know the NZ protocols are shoddy based on the testimony of the ME, but even I don’t believe you think the ME results should be inadmissable in a coronial investigation. I mean, what would the coroner have to investigate if interested parties don’t bring in experts from abroad? I know the coroner in this case complimented the family for seeking other opinions, but even I don’t think he intended to omit your version of “unverified science” like the ME’s test results despite it lacking “good clinical practice”. I’m OK if you want to admit you blew it the first time and change your argument, but instead you seem to want to keep digging deeper.

@grant “this seems all over the place. Reading a paper is not crashing a poll and reading the paper would be entirely in anyone’s objectives if they were checking what it said.”

Your computerized method of fraudulantly incrementing the access count is very similar to methods used to crash an online poll. I’m surprised you didn’t recognize that.

@grant “It’s also possible, if not probable, that the high count is, in part, due to SaneVax groupies and others they have promoted this work to (Lee’s paper and the work in it were paid for by SaneVax — as noted in the paper — and SaneVax has been busy touting it through press releases and whatnot, as a quick google search will verify.”

Earth to Grant: The HPV genotyping methodology paper was not paid for by SaneVax nor is it about the coronial investigation, or Gardasil since it was published in 2007! For an armchair researcher, you sure seem to make a lot of stupid assumptions. My kids know how to check simple facts like clicking the link and looking at the date. If you google the link you won’t find any references from any auntie maxine or sanevax blogs either. Based on the evidence, it is highly unlikely any groupies except the ones here know about it. So unless you fraudulantly elevated the statistics through the methods you described earlier (post #478), that methdology paper has generated a lot of interest in the medical community.

@grant “My polite corrections and pointing out your errors must getting under your skin: you’re trying so hard to make me out to have said and done things I haven’t.”

Yelling troll, troll is hardly polite. It seems I’m the one who has a lot of patience walking you through all your invalid assumptions and bad arguments. At least you’ve stopped defending that IMAC rubbish so we made some baby steps progress there, but I just have to point out again you’ve totally avoided talking about the science of the report… again.

@Narad “Are you or are you not willing to admit that SCIRP is the bottom of the barrel?”

Are you or are you not willing to admit that the journal of publication has no bearing on the content or quality of any specific paper?

I am not. Now answer the original question.

@JGC “non-B conformer, thank you for pointing out a second logical error that’s been pointed out to you, but you prefer to ignore…”
That’s non-B conformation. The logic was clearly stated both here and in the case report. Since you bring up bimler, he still hasn’t answered the key question in post #472. If you disagree with the logic explained in the paper, then please answer: How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair? Silence from everyone so far.

You see, you seem just like the others: Parroting some sciency sounding arguments from textbooks, groupies, or even unrelated PCR lab work, but unable to address the real meat of the problem. By now it should be obvious to even you that discussing the details requires some practical knowledge and real lab experience finding target HPV DNA mixed with human genomic DNA.

In addition to the question above, despite numerous pleadings that population studies are required to qualify the finding as unique, not a single person here has been able to articulate a scientifically plausible source (aside from the vaccine) for HPV-16 L1 DNA fragments in non-B conformation in the autopsy tissues. Nada.

That means those two arguments of false or missing logic are totally unsubstantiated by anything other than rhetoric so far.

@Narad “I will take that as a concession that you cannot defend your assertion.”

Bad assumption. Read post #486. Lilady did your homework for you.

Sorry, kid, show me the poll crashing. With feeling. Oh, and the “well-known” part. In detail.

@Narad “I am not”

Then you offer a splendid example of flawed logic because you should judge a paper you have access to based on the contents, not based on where or how it’s published. Unless of course, you can’t actually understand what they’re talking about and need to defer to some other authority. That’s a different flaw.

@Narad “Now answer the original question.”

No, I won’t answer, because when you have the details in front of you, it’s not relevant. It only comes into play if you’re using irrational flawed logic or deferring to authority. I prefer to avoid both of those things.

@Narad “Sorry, kid, show me the poll crashing. With feeling. Oh, and the “well-known” part. In detail.”
Detail? Do your own homework. Lilady validated it. For more evidence it’s straight from the great leader’s mouth: “If you can’t beat ‘em, join ‘em: Crash this poll” on December 31, 2008. No apology or thanks required, it’s called Google old one.

Opps, missed the blockquote in #504.

@Narad “Sorry, kid, show me the poll crashing. With feeling. Oh, and the “well-known” part. In detail.”

Detail? Do your own homework. Lilady validated it. For more evidence it’s straight from the great leader’s mouth: “If you can’t beat ‘em, join ‘em: Crash this poll” on December 31, 2008. No apology or thanks required, it’s called Google old one.

@Narad “Now answer the original question.”

No, I won’t answer

Must suck to be a chickenshıt.

@Narad “Must suck to be a chickenshit.”

I think it sucks a lot worse to be illogical or wrong. Dishonest questions premised on false logic should not be answered. Don’t take it too personally now.

Detail? Do your own homework. Lilady validated it. For more evidence it’s straight from the great leader’s mouth: “If you can’t beat ‘em, join ‘em: Crash this poll” on December 31, 2008. No apology or thanks required, it’s called Google old one.

Nope, fail. Perhaps you’re thinking of Pharyngula. I don’t need to do your homework, but apparently you don’t grasp the underlying concept. Lilady voted on a poll, so “Orac’s groupies have been known to crash online polls”?

Do I get to be a “groupie” even though I don’t give a rat’s ass about online polls?

@Narad “Must suck to be a chickenshit.”

It sucks to be illogical or wrong. Dishonest questions premised on false logic should not be answered. Don’t take it too personally now.

@Narad “Nope, fail. Perhaps you’re thinking of Pharyngula.”

I gave you the OP title and the date and the blog (hint: this one, not Pharyngula). If you can’t find the link, then the failure is clearly not on my end. The title says it all.

@Narad “Do I get to be a “groupie” even though I don’t give a rat’s ass about online polls?”

You’re asking me? Why don’t you ask lilady? She seems to know the entry criteria and proudly wears the badge.

@Narad “Must suck to be a chickenshit.”

It sucks to be illogical or wrong. Dishonest questions premised on false logic should not be answered. Don’t take it too personally now.

There is no “dishonest question.” I asked you a question, and you retreated to asking one instead, I answered yours, and now I would like you to get back to the original one. You have refused, and when challenged, have resorted to simple babbling. Answer the question.

Mr. Pink, you seem to be assuming I lack sufficient real knowledge and practical lab experience to be able to understand Lee’s publication and identify the logical problems with his claims. That isn’t the case.

But let’s assume I was that ignorant of PCR amplification.. That ignorance wouldn’t alter the fact that Lee’s has failed to demonstrate the DNA he amplified was vaccine in origin or present in as a non-B. conformation.

Mr. Pink,

The methodology of using nested PCR for HPV genotyping is not a new methodology which you and a few others just can’t seem to get through your heads.

If so, why did Lee write this?

This paper reports the experience in developing a method for the detection and validation of minute quantities of HPV-16 L1 gene DNA in the postmortem blood and spleen obtained at autopsy.

Taking an example from my own field, if I developed a method for measuring serum rhubarb using an enzyme-linked immunosorbent assay, I would still have to demonstrate its specificity and sensitivity, even though ELISA is an established methodology. I most certainly wouldn’t use it to analyze post-mortem samples and suggest that the person died of a rhubarb overdose until others had replicated and validated my new method.

The important point here is that Lee is behaving in an irresponsible manner by publishing an alarmist paper that is clearly designed to frighten people away from HPV vaccines. His findings are even more implausible than the malarial Inuit you posited above, and his conclusions linking these findings with a young woman’s death are extremely premature. Couching his conclusions with a lame disclaimer about further research being required doesn’t excuse his behavior. He knows perfectly well he is being used as a propaganda tool by people whose beliefs about HPV vaccines are already fixed and who are only interested in evidence that supports them, no matter how reliable it is. I have little doubt that there are some people who will avoid Gardasil because of Lee’s work, and that some of these will develop HPV and cancer and die as a result.

Well, this conversation devolved nicely. Marg was more fun as a chew toy, she had more pizazz.

Arguments from popularity are now apparently known as ‘facts’. Even with her postmodernist views she never managed to pull that one out but would have done it with more style…

@Narad “Are you or are you not willing to admit that SCIRP is the bottom of the barrel?”

They are not. I won’t put them at the top of the pile, but there are a lot of very bad bogus publishers and bogus journals. Some open access, some subscription and some “free” industry funded.

@Narad

Mr Pink posted: “If you can’t beat ‘em, join ‘em: Crash this poll”

I’ll take your silence on Orac’s OP, as a concession that you accept my assertion.

@JGC “Mr. Pink, you seem to be assuming I lack sufficient real knowledge and practical lab experience to be able to understand Lee’s publication and identify the logical problems with his claims. That isn’t the case. But let’s assume I was that ignorant of PCR amplification..”
What a bizarre point to make: I must have been wrong in my assumption, but let’s go with it anyways?
I didn’t make an assumption, I made an observation. You made a strawman, because my observation was far more qualified than you lacking PCR experience in a lab. I observed that it seems like you lack lab experience detecting target HPV DNA mixed with human genomic DNA. I would be delighted to find out that was wrong, but you have provided nothing to indicate otherwise.

@JGC “But let’s assume I was that ignorant of PCR amplification.. That ignorance wouldn’t alter the fact that Lee’s has failed to demonstrate the DNA he amplified was vaccine in origin or present in as a non-B. conformation.”

Non-Sequitur. If you are ignorant of PCR amplification and by corollary, DNA in non-B conformation, you could not practically dispute the claim of the HPV-16 L1 DNA fragment in non-B conformation as it requires an understanding of both topics.

But since you claim adequate expertise, stop assuming anything. If you insist the HPV-16 L1 DNA fragment is not in non-B conformation, then please provide a articulate description of the results from the case report. How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

Without answering that question, your criticism amounts to unsubstantiated claims, and that is the farthest thing from fact despite your pleadings.

Blockquote fail again.

@JGC “Mr. Pink, you seem to be assuming I lack sufficient real knowledge and practical lab experience to be able to understand Lee’s publication and identify the logical problems with his claims. That isn’t the case. But let’s assume I was that ignorant of PCR amplification..”

What a bizarre point to make: I must have been wrong in my assumption, but let’s go with it anyways?
I didn’t make an assumption, I made an observation. You made a strawman, because my observation was far more qualified than you lacking PCR experience in a lab. I observed that it seems like you lack lab experience detecting target HPV DNA mixed with human genomic DNA. I would be delighted to find out that was wrong, but you have provided nothing to indicate otherwise.

@JGC “But let’s assume I was that ignorant of PCR amplification.. That ignorance wouldn’t alter the fact that Lee’s has failed to demonstrate the DNA he amplified was vaccine in origin or present in as a non-B. conformation.”

Non-Sequitur. If you are ignorant of PCR amplification and by corollary, DNA in non-B conformation, you could not practically dispute the claim of the HPV-16 L1 DNA fragment in non-B conformation as it requires an understanding of both topics.

But since you claim adequate expertise, stop assuming anything. If you insist the HPV-16 L1 DNA fragment is not in non-B conformation, then please provide a articulate description of the results from the case report. How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

Without answering that question, your criticism amounts to unsubstantiated claims, and that is the farthest thing from fact despite your pleadings.

@Krebiozen “If so, why did Lee write this?”

Do I really need to describe the difference between “method” and “methodology”? The specificity of the results was well documented in the case report.

@Krebiozen “The important point here is that Lee is behaving in an irresponsible manner by publishing an alarmist paper that is clearly designed to frighten people away from HPV vaccines.”

So elegantly stated as fact despite you having admitted non-expertise in the area covered by the report. Given that you can’t articulate an issue with the science, your claim (not fact) of irresponsible behavior is unsubstantiated. As for your claims of “alarmist” paper, I think that is dubious as well. This was the conclusion:

Detection of HPV-16 L1 gene DNA fragments in non-B- conformation in postmortem blood and spleen from a person who died suddenly and unexpectedly 6 months after quadrivalent HPV vaccination has not been previously reported and warrants further investigation.

A call for investigation is hardly alarmist. This is especially true in a scientific paper that can only be comprehended by those who have expertise in HPV genotyping which excludes 99.999% of the population. There are more than enough VAERS entries describing serious Gardasil reactions resulting in morbidity and mortality that this is barely a blip on the “alarmist” scale. The scientist doth protest too much, methinks.

@Krebiozen “…and his conclusions linking these findings with a young woman’s death are extremely premature.”

The unique and unexpected findings in autopsy tissues are linked to her death by the fact they were done as part of a post mortem investigation. The real question is causation, and no definitive conclusions were claimed. However, plenty of evidence was given during the coronial hearing to justify further investigation, which is exactly what the case report recommended based on the findings.

@Krebiozen “I have little doubt that there are some people who will avoid Gardasil because of Lee’s work, and that some of these will develop HPV and cancer and die as a result.”
Such a definitive and confident prediction based on a faith in industry and HPV vaccine strategy. There isn’t an ounce of quality evidence showing the vaccine has or will ever reduce the incidence of cervical cancer. That’s why people should avoid Gardasil, not because of one linked death. Isn’t this supposed to be the site of Science Based Medicine? I forgot, Orac dropped the evidence part.

@Krebiozen “He knows perfectly well he is being used as a propaganda tool by people whose beliefs about HPV vaccines are already fixed and who are only interested in evidence that supports them, no matter how reliable it is.

How hypocritical. What do you think this blog is all about? You exposed your true colors with that gem of an argument Krebiozen.

Arg, You would think WordPress would offer preview…

@Krebiozen “I have little doubt that there are some people who will avoid Gardasil because of Lee’s work, and that some of these will develop HPV and cancer and die as a result.”

Such a definitive and confident prediction based on a faith in industry and HPV vaccine strategy. There isn’t an ounce of quality evidence showing the vaccine has or will ever reduce the incidence of cervical cancer. That’s why people should avoid Gardasil, not because of one linked death. Isn’t this supposed to be the site of Science Based Medicine? I forgot, Orac dropped the evidence part.

@Krebiozen “He knows perfectly well he is being used as a propaganda tool by people whose beliefs about HPV vaccines are already fixed and who are only interested in evidence that supports them, no matter how reliable it is.

How hypocritical. What do you think this blog is all about? You exposed your true colors with that gem of an argument Krebiozen.

I’ll take your silence on Orac’s OP, as a concession that you accept my assertion.

No, in fact I do not. You stated the following:

Certainly, Orac’s groupies have been known to crash online polls.

You have, as your lone example (and please try to learn what “OP” means), this, which of course immediately invokes PZ. And Lilady stating that she voted in a some online poll somewhere. So who’s been “known” to do what? Who are the “groupies”? Where’s the evidence?

Where’s the non-B conformation DNA?

@Krebiozen,

Good comparison.

@Mr Pink,

So you continued to put words in others’ mouths, offer twisted, distorted, versions of what others have written, slurring the writer each time with cheap shots?

Great way to show everyone you’re trolling. (See also comment #478.)

In your latest, you repeatedly made inaccurate claims about me (to be polite). I can’t be bothered with your silliness, really, but it’s perhaps worth illustrating for other readers the extent you mess up others’ words (for whatever reason) with one example that they might find easy to follow.

(If for nothing but entertainment’s sake, I suppose.)

I tried to point out to you the paper under question here is paid for by SaneVax, saying that was stated in the paper.

Ignoring the cheap shots, in comment #499 you said:

“The HPV genotyping methodology paper was not paid for by SaneVax”

My statement was about the current paper. (You know, the one being talked about.) You made my statement to be about some earlier paper. Goodness knows why, but clearly this twists, gets wrong or whatever, the meaning of what I wrote. So, QED. Then you compound this error or deception by going on to try “fit” a lot of other things I wrote under your strange re-interpretation.

The paper at hand is paid for by SaneVax, it says so in the paper:

“This study was commissioned and sponsored by SANE VAX, Inc.”

It couldn’t be clearer.*

Just a thought: some might say you are trying to deflect attention from a conflict of interest by arguing if some earlier paper is not paid for by SaneVax then Lee’s recent work can’t have a conflict of interest either (which is illogical). SaneVax state on their website that they recruited Lee to test patients. Others can verify this, but I believe SaneVax stated that before this coroner’s inquiry. It would follow that Lee’s involvement with the Renata samples has been entirely within his time of involvement with SaneVax.

I think it’s clear to everyone that you seem unable to accurately note what has been written by others. (To be polite.)

I could speculate why you do that, but whatever the reason might be I think the way you treat others speaks for itself.


* This statement has SaneVax commissioning the study into the sample, as opposed to carrying it out on behalf of a third party.

@Narad “Are you or are you not willing to admit that SCIRP is the bottom of the barrel?”

They are not. I won’t put them at the top of the pile, but there are a lot of very bad bogus publishers and bogus journals. Some open access, some subscription and some “free” industry funded.

I see, there’s a pile. (Well, a pile of something, to be certain.) SCIRP has trotted out a stable of approximately 150 journals in the space of six years. Again, they have “published” articles from other journals to pretend that their inventions have submissions. They have accepted an article from a random text generator.

What does it take to get a retraction? Republishing something that has already been retracted for plagiarism, apparently.

They can’t even set the HTML or PDF of a retraction competently. This stable is garbage. It is the putrefying corpse of a pregnant mouse that the cat brought in and left in your shoe. Strangely, you seem to wish simultaneously to argue that the journal is irrelevant but the publication in the journal lends credibility.

The best defense that SCIRP could possibly establish is that it might allow “third world” authors to get published in lieu of real journals that assess page charges. But this also appears to be a crock, as every society EIC I’ve encountered has had a fund specifically for this purpose. If you are doing sound work, even basic observational work, you don’t need a vanity press.

But let’s return to the orignial hierarchy that you’ve asserted. Clearly, you are reduced to trying to would like to try to drag in Elsevier’s unseemly practice of having sold ghostwritten, bought-and-paid-for titles. This may surprise you, but they’re not the only game in town. But anyway, tell me: who’s lower on “the pile” than SCIRP? Does it rhyme with “eunuchs”?

@Grant “Great way to show everyone you’re trolling. In your latest, you repeatedly made inaccurate claims about me (to be polite). I can’t be bothered with your silliness, really, but it’s perhaps worth illustrating for other readers the extent you mess up others’ words (for whatever reason) with one example that they might find easy to follow.”

Given your persistence with that line of argument, I’m beginning to think you’re purposefully playing a dupe in some bizarre attempt to paint me as the troll. You also sound like you’re going to run off again (post #329), without ever addressing the science. It’s a shame that was a lie the first time (and that is being polite), since you’ve come back over and over and over, and still You refuse to discuss the case report. Your trolling obsession looks more like a projection but you’re right on one count, you have been entertaining.

@Grant “My statement was about the current paper.”

You need to learn to write what you mean. This is what you said: “It’s also possible, if not probable, that the high count is, in part, due to SaneVax groupies and others they have promoted this work to[sic]” [emphasis mine] “The high count” refers to the methodology paper and without another subject in the sentence “this work” appears to apply to the same unless otherwise qualified. Indeed, the whole paragraph opens by discussing reading “a paper” with high counts. To be polite, I’ll assume you just weren’t articulate enough, instead of trying to move the goalpost. Examining your modified argument reveals it doesn’t make any sense, because the methodology paper isn’t promoted by the blogs, or articles about the case report. Your explanation for the high read counts is non sequitur now. You continue to back yourself into lose/lose arguments. So which way will you have it: Shifting goal post or non sequitur?

@Grant “Just a thought: some might say you are trying to deflect attention from a conflict of interest by arguing if some earlier paper is not paid for by SaneVax then Lee’s recent work can’t have a conflict of interest either (which is illogical).”

Yes, it is illogical and lo and behold: You’re the one who wrote it. It’s even more illogical since I’m sure the $1 commission generated a ton of conflict. Unlike IMAC, I have no need to deflect anything about COI. Cognitive dissonance down under?

@Grant “I think it’s clear to everyone that you seem unable to accurately note what has been written by others. (To be polite.)”

As I described above, what’s quite clear is that you can’t articulate a coherent argument (to be polite). I see you’ve wisely stopped holding up the IMAC paper as anything relevant to the case report in the OP. Perhaps you should examine the rest of your arguments here with the same rigor given that you still have not said anything about the science in the report being discussed by the OP. (to be polite) Or, perhaps you’ll actually do what you said almost 200 posts ago, and go off and do other important things — like convincing hippies to vaccinate their kids (to be really polite).

@Grant
Earth to Grant: One more time. It’s post #520+ and You still haven’t commented on the science in the report. (to be blunt)

@narad “You have, as your lone example (and please try to learn what “OP” means), this, which of course immediately invokes PZ.”

Contratulations on finally getting the google query to work. Are you trying to shift the goalpost now by pointing out that he “invokes PZ” because you were pretty sure Orac didn’t do it. You said: “Nope, fail. Perhaps you’re thinking of Pharyngula.” The fail is clearly yours. I quote the OP I referenced:

I know, I know, I’ve criticized P.Z. Myer’s poll-crashing proclivities as being childish and pointless. However, so few people seem to agree with my take on it that I’m wondering whether, if I can’t beat ‘em I should join ‘em. So let’s try it out.

As for groupies being involved, I’m guessing you forgot to read the comments old one.

You also complain about a lone example. As someone in the “publishing racket” your own research capabilities appear questionable. Try looking up “Another idiotic poll: Do you think vaccines are safe?” on August 29, 2010. I’ll help you out by quoting the OP right away so you don’t confuse the author again in disbelief:

On the front page, there is a poll of such epic burning stupid that it requires an immediate crash. I may not be P.Z., but I have in some instances overcome my previous dislike of poll crashing, especially when it’s a poll this stupid:

Don’t forget to read the comments this time. I want to know though, are you really new here, or do you just have a defective memory?

@Narad “I see, there’s a pile…”

If you’re done foaming about the mouth about OA journals who happen to be disrupting your decreasingly profitable publishing “racket”, then you might realize that when you have a fully detailed case report — with all the details to allow anyone to reproduce it — you should probably read it. Instead of trying to tar papers based on the publisher or other similar arguments of authority, you might actually have to understand the science. Open access, the internet, and a raft of civil court cases, have allowed people to expose the crap in “the pile” for what it is coming from the new or old publishers. Whether the new problems cropping up are worse than the old ones is a good question, but it won’t change the inevitable. Whether you, bimler, or others (like the defenders of monastic education) like it or not, the fallacy of authority defence long wielded by the old guard of the science establishment is crumbling. Enjoy the last vestiges of it while it lasts a few more years. Since you fixate on things like proper PDF publication, it seems logical that you would give Grant and that IMAC group (a purported NZ “authority” on vaccines) a hand since they appear to have some competency issues in that department as well.

@Narad “Where’s the non-B conformation DNA?”

By spending more time reading the paper instead of fixating on the name of the publisher, you might avoid asking questions which have already been answered in the report. Since you disagree with the assertion in the paper, answer the question: How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

Given your persistence with that line of argument, I’m beginning to think you’re purposefully playing a dupe in some bizarre attempt to paint me as the troll.

Oh, the irony.

If you’re done foaming about the mouth about OA journals who happen to be disrupting your decreasingly profitable publishing “racket”

The vast majority of my experience is in nonprofit publishing. Societies, remember? I assure you that for-profit journals publishers such as Elsevier are doing just fine, because they have monolithic control over not just price but what’s in the package. And the likes of SCIRP and OMICS represent a threat to absolutely no one.

Mr.Pink,

There isn’t an ounce of quality evidence showing the vaccine has or will ever reduce the incidence of cervical cancer. That’s why people should avoid Gardasil, not because of one linked death.

Disingenous nonsense (PDF). We have every reason to believe the vaccine will reduce the incidence of cervical cancer. It has been proven to reduce the risk of cervical changes that are known to be associated with cervical cancer in the short term, so it would be extraordinary if it isn’t found to reduce the incidence of cervical cancer in the longer term.

Disingenous nonsense

Well, I take it that “quality evidence” means published in a vanity press and financed by a special-interest group.

I should probably also address this:

How hypocritical. What do you think this blog is all about? You exposed your true colors with that gem of an argument Krebiozen.

It wasn’t an argument, I was expressing my opinion. Having looked at much of the available evidence, the benefits of HPV vaccines seem to me to greatly exceed any possible risks. That’s not hypocritical, that’s rationally weighing the evidence. I have no dog in this fight, I simply want to see people protected against HPV and the cancers it causes.

Are you seriously suggesting that all the safety and efficacy studies and post-marketing surveillance on HPV vaccines are faked by the industry? That HPV DNA (in amounts so tiny nested PCR is needed to even detect them) somehow migrated from a young woman’s arm muscle to her brain and killed her 6 months after vaccination? As the old maxim goes, extraordinary claims require extraordinary evidence, and I need to see something a lot more robust than Lee’s studies before I give this any credence at all.

Mr Pink @ 516 says –

This is especially true in a scientific paper that can only be comprehended by those who have expertise in HPV genotyping which excludes 99.999% of the population.

Are you part of the population who have expertise in HPV genotyping?

If so, where and how did you come by this expertise? How do you use genotyping in your daily life?

I’m just going to do this piecemeal, as my attention is scattered between tasks today and, really, it doesn’t merit anything more.

Whether you, bimler, or others (like the defenders of monastic education) like it or not, the fallacy of authority defence long wielded by the old guard of the science establishment is crumbling. Enjoy the last vestiges of it while it lasts a few more years.

This nothing more nor less than an argument against genuine peer review itself, coupled with an argument for shoddy peer review in some sort of weird Levellers gambit. You are, in effect, advocating precisely this.

If the “establishment” is “crumbling,” why did Lee bother to ape it using a vanity publisher?

Mr Pink stated earlier that

There are more than enough VAERS entries describing serious Gardasil reactions resulting in morbidity and mortality that this is barely a blip on the “alarmist” scale.

Now I wonder why/how he jumps to the conclusion that any events that follow vaccination are necessarily “serious gardasil reactions”? Has he not realized that anyone can report any event they like, and that such amazing “serious gardasil reactions” like a fatal car crash, or a death from congenital heart disease 6 months after the second gardasil shot have been recorded on VAERS? I guess not. Perhaps he should stop using VAERS for purposes it was not designed for, and look at other less malleable sources of information on gardasil safety/reactions.

Mild amusement may be derived from Googling “Sin Hang Lee” along with the name of his attorney, Anthony J. Musto.

Contratulations on finally getting the google query to work. Are you trying to shift the goalpost now by pointing out that he “invokes PZ” because you were pretty sure Orac didn’t do it.

Um, no, I didn’t need “the google query,” as I was around for that. Your second sentence is simply incoherent. PZ is known for encouraging “poll crashing” and was invoked at the very start of the item that you first cited. “Orac’s groupies” are not particularly “known to crash online polls,” perhaps because nobody much gives a damn about them in the first place.

You, on the other hand, advanced the strange position that download stats for Lee’s article were somehow meaningful, which just seems to be a rehash in structure of the contradictory position that you have adopted regarding journals.

his attorney, Anthony J. Musto

Connecticut State Senator Anthony J. Musto is probably ex-attorney, I imagine.
Perhaps whoever is representing Sin Hang Lee in his suit against Milford Laboratories will have better luck. He does not have much luck with employers, does he?

Sin Hang Lee’s suit against the FDA (with Musto representing HiFi DNA) was mentioned by lilady and Laura in a previous thread:
https://www.respectfulinsolence.com/2011/09/06/oh-no-theres-dna-in-my-gardasil/#comment-160195

@Krebiozen

“Disingenous nonsense (PDF). We have every reason to believe the vaccine will reduce the incidence of cervical cancer. It has been proven to reduce the risk of cervical changes that are known to be associated with cervical cancer in the short term, so it would be extraordinary if it isn’t found to reduce the incidence of cervical cancer in the longer term.”
Did you read your own sentence above? “We have every reason to believe the vaccine will…” That is speculation and faith. Did you read your own evidence: “However, both vaccines may provide sufficient immunogenicity to confer long-term protection.” That is hardly evidence supporting a positive statement like “every reason”. The least you could do is provide evidence that matches your own description. You also said “It has been proven”. No one running clinical trials uses definitive language like that. This is medicine, not mathematics. As for the evidence itself, it clearly does not study the desired endpoint which is cervical cancer and it only studies a subset of cervical lesions. Either one of these is enough to exclude it as high qualify, but both make it a no-brainer.

“It has been proven to reduce the risk of cervical changes that are known to be associated with cervical cancer in the short term, so it would be extraordinary if it isn’t found to reduce the incidence of cervical cancer in the longer term.”

If anyone is being disingenious, it is you and the pharmaceuticals. Targeted study from pharmaceutical trials almost never translate to population reality regarding efficacy or safety. It is especially true with vaccination as the time between the shot and the measured outcome increases. Evidence dictates it would be extraordinary if reality matched the outcomes outlined in the narrow study you provided. Your evidence does not and can not consider serotype replacement, long term efficacy, or failure cases. Think about it, a tiny percentage of women get cervical cancer but many get HPV infections. Only repeated infection from the same strain ultimately results in cervical cancer. So why are some very small percentage of women’s immune systems not able to prevent subsequent infection of the same strain? We don’t know and I find it highly suspect to assume that a woman suffering from an immune system problem that results in persistent infection from the same strain (i.e. they don’t develop immunity), will somehow develop long term immunity from a vaccine which relies on a similar mechanism.

The key point here, is that you and I are both speculating. That’s because as I stated earlier, there is no high quality evidence to support the hypothesis that mass HPV vaccination will reduce the incidence of cervical cancer in the population primarily because the cerivcal cancer outcomes can’t be studied yet. Until then, it’s just a big clinical trial being run at the population level and no scientist worth their salt uses definitive language about the outcome of a clinical trial before the end point data is collected, let alone analyzed.

“It wasn’t an argument, I was expressing my opinion.”

It’s funny you claim to express opinion yet what you said was worded as a statement of fact. Why don’t you go re-read your paragraph and see how much is worded as an opinion? “The important point here is that Lee is…” — definitive statement of fact. “His findings are even more implausible than the…” — definitive statement of fact. “…and his conlusions linking… are extremely premature.” — definitive statement of fact. “He knows perfectly well he is being used as…” — definitive statement of fact and that’s the one I quoted. You open the paragraph with “The important point here is that Lee is behaving…”. That sounds a lot more like an argument than an expression of opinion. But it’s OK, I’ll let you shift the goalpost. Here is my modified response: You showed your true colors with that opinion.

“Are you seriously suggesting that all the safety and efficacy studies and post-marketing surveillance on HPV vaccines are faked by the industry?”

Good grief no. Are you pretending to write a strawman? Post marketing surveillance is severely limited (ask dingo as s/he is bursting to talk about it), so there is no need to fake it. As for regulatory trials, no need to fake them either (unless you have something as bad as vioxx). Read the NEJM amicus brief (for Levine) to the SCOTUS in the Wyeth vs Levine case a few years back. They compiled a ton of high quality peer-reviewed evidence (up to Narad’s standards I’m sure) to argue that regulatory trials and regulatory agencies can not identify or protect the population from problems with pharmaceuticals (fakery or no fakery). That’s why the SCOTUS kept the right to sue pharmaceuticals in place, as they acknowledged that it was the only way to protect the public interest. It is sad to note that such protection is not afforded to the public in the case of vaccines.

@Narad “Orac’s groupies” are not particularly “known to crash online polls,” perhaps because nobody much gives a damn about them in the first place.

LOL, denial in the face of contradicing evidence. Looks good on you just like the illogical ideas around tarring a paper based solely on who published it.

@Narad “The vast majority of my experience is in nonprofit publishing. Societies, remember?”

In #421 all you said was journal publishing was your racket and in #520 you encountered society EICs. Remember? Post the quote from this topic where you outlined the majority of your experience as the fully qualified nonprofit publishing industry.

@Narad “You, on the other hand, advanced the strange position that download stats for Lee’s article were somehow meaningful, which just seems to be a rehash in structure of the contradictory position that you have adopted regarding journals.”

A claim was made to the effect that no one reads Dr Lee’s papers. The download statistics are meaningful with respect to showing interest in the paper. The rest is your strawman.

@dingo199 “Now I wonder why/how he jumps to the conclusion that any events that follow vaccination are necessarily “serious gardasil reactions”?”

Nice dimwitted strawman. I didn’t draw any conclusions about the validity of the reports. I described what is in VAERS because such entries — regardless of their validity — will cause way more alarm than this case report. Of course, that would have required you to read and understand all of what I wrote in context. Let me guess, you’ve been waiting to jump in, you saw VAERS, and your brain stopped working because you happen to know its limitations. You thought: that dumb Mr Pink really screwed up this time. ROTFL. Please, keep posting dingo199. You’re dragging down the groupie score. Do you have a comment to make about the case report?

@Johnny “Are you part of the population who have expertise in HPV genotyping? If so, where and how did you come by this expertise? How do you use genotyping in your daily life?”

Do you have a point to make about the case report? The big outstanding question right now is: How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair? Many here say Dr Lee is wrong about his assertion in the report, but not one of them will answer the question. Funny that.

Read the NEJM amicus brief (for Levine) to the SCOTUS in the Wyeth vs Levine case a few years back. They compiled a ton of high quality peer-reviewed evidence (up to Narad’s standards I’m sure) to argue that regulatory trials and regulatory agencies can not identify or protect the population from problems with pharmaceuticals (fakery or no fakery). That’s why the SCOTUS kept the right to sue pharmaceuticals in place, as they acknowledged that it was the only way to protect the public interest. It is sad to note that such protection is not afforded to the public in the case of vaccines.

This is a blindly stupid remark to the extent that it’s comprehensible at all. The default assumption is traditionally against preemption. You are, in effect, attempting to invoke Bruesewitz. The amicus brief is irrelevant to the decision. Levine turned on labeling.

(And was also a warning-defect claim, not a design-defect claim. I recommend that Pink stick to other things that he doesn’t understand.)

@Narad

Whether you, bimler, or others (like the defenders of monastic education) like it or not, the fallacy of authority defence long wielded by the old guard of the science establishment is crumbling. Enjoy the last vestiges of it while it lasts a few more years.

This nothing more nor less than an argument against genuine peer review itself, coupled with an argument for shoddy peer review in some sort of weird Levellers gambit. You are, in effect, advocating precisely this.

If the “establishment” is “crumbling,” why did Lee bother to ape it using a vanity publisher?

Let’s not forget Mr Pink’s argument started off with Lee being THE authority on PCR, having written the book on it, and is such an authority on the topic we should simply accept the paper without question.

@Narad “Are you or are you not willing to admit that SCIRP is the bottom of the barrel?”
They are not. I won’t put them at the top of the pile, but there are a lot of very bad bogus publishers and bogus journals

Mr Pink has us there, Narad. When I reflect on it, it is rash to describe the SCIRP journals as the absolute bottom of the barrel, when there are indeed even more egregious scams — such as the people who fired up the random-text generator and constructed seven fictitious previous issues of their junkjournal, to give the rubes the impression of a publication history.

If you’re done foaming about the mouth about OA journals who happen to be disrupting your decreasingly profitable publishing “racket”

I believe this to be an example of what the young people call a “straw man, possibly large enough to burn Patrick McGoohan alive, since I can’t recall anyone here criticising OA journals per se. Only the crooked ones. I wager that some of the commenters have published in or are on the peer-review panels of journals from Frontiers or PLoS or BioMed Central.

the fallacy of authority defence long wielded by the old guard of the science establishment is crumbling.

Just for clarification, is Sin Hang Lee — “who has basically written the book on high sensitivity PCR testing” — part of this Crumbling Old Guard Authority?

I’ve no need to comment on the case report, Mr Pinkie. You’re screwing the narrative on that well enough on your own. I just thought it apposite to contrast your blind faith in VAERS with your decrial of other more reliable vaccine safety studies.

Mr Pink @472
That’s a major analogy fail at the most basic level.

The lack of effort you are putting into this thread is depressing. The analogy between reporting malaria in a “native Eskimo living near the North pole” [a North Dane, some of my colleagues would say] and reporting “HPV DNA in non-B conformation in human tissue” is yours (comment #452), so if it fails, don’t blame me. I merely pointed out that in both cases, one would want validation of the method used to detect the unexpected condition “against people known to have [$CONDITION]” (comment #468).

Your response is that the reagent has been validated to Sin Hang Lee’s satisfaction in a different test for a different purpose:

The HiFi polymerase used in the LoTemp PCR has been validated and shown to be more effective in amplifying HPV-16 DNA

I can’t see any mention in the Infect Agent Cancer. paper of non-B conformation. I’ve read it. Have you?

Did I miss Mr Pink’s answer to Johnny’s question?

Given that, per Mr Pink, the paper in question “can only be comprehended by those who have expertise in HPV genotyping which excludes 99.999% of the population”, it’s fair to wonder if Mr Pink is “part of the population who have expertise in HPV genotyping”. Orac, of course, most certainly is part of that population.  

Before Mr Pink jumps on me, let me add an omitted step: expertise in HPV genotyping specifically doesn’t seem required, but expertise in using PCR and genotyping in general would be. Mr Pink has not offered evidence that HPV is so uniquely different from all other viruses in existence that expertise with other viruses cannot offer an understanding of HPV.

@Mr Pink:

I guess any possible confusion could not possibly be because Mr Pink was not being clear because Mr Pink is Always Right and Knows So Much More than anyone else.

JK. Mostly.

I don’t have to paint you as a troll: you act like one (even in the paragraph you wrote that).

“I see you’ve wisely stopped holding up the IMAC paper as anything relevant to the case report in the OP.”

Still trying to foist this particular twist and bait on me? Trying to make out that from not saying something that I have done some particular thing is illogical and, besides, here you, who keeps accusing others of using strawmen, is using a strawman.

You criticised everything but what the IMAC document said about Lee and his work. In particular, you tried to shoot the messenger – and still seem to want to. I pointed out that you at the time. There’s not much more I can do than that.

I suppose could “demand” that you address the points made there in the way that you are “demanding” things of me, but really it’s your choice not to engage with it if you don’t want to.

“You still haven’t commented on the science in the report”

I guess you have forgotten that I have actually pointed out some issues with Lee’s work from your mind, but never mind.

I choose to leave aside most of your statements about Lee’s science because the paper has bigger issues, as I pointed out some time ago.

Like anyone here I don’t “have” to reply to you, never mind address particular things that you would like others to. You don’t get to dictate what others “must” do. Similarly, my not replying on any one thing doesn’t mean a thing.

On the subject of the standing of the ABB journal: One simple way to judge if a journal in the bio-med area is up to a reasonable standard is to check if Medline has indexed it. It’s not an infallible way of doing this, but Medline looks at the standard of peer review and the policies of the journal, etc. Medline indexes thousands of journals in the bio-med area. The journal the paper by Lee that Orac examined above (ABB) is not indexed by Medline.

Another way is to see if the journal falls in the list of vanity publishers (previously linked by others). As a SCRIP journal, ABB is on this list as others have pointed out.

There are also list of journal rankings you can inspect.

I could go on. The bottom line is that you can’t really avoid that with or without the vanity element ABB is a bottom-end journal. It’s just the way it is.

Regards my points: the points themselves stand – some might suggest you are trying to use tit-for-tat about who said what in what order to distract from from the points themselves. (I haven’t time for the side-issue of the sequence of discussion: the sort of thing you’re driving to seems more than a bit inane to me.)

You seem to be arguing that COIs can only about money (something I’ve seen anti-vaccine proponents say). SaneVax said they commissioned and sponsored the study: that is the issue.

(I have other concerns on this issue, but enough for now.)

Finally, it’s worth reminding you that it was you that argued from authority from your first comment here, saying that His Word Will Rule And Will Be Right Because He Is The Grand Expert. (Sorry, but you get the point.) It’s the basic fallacy you built this on. After you were shown up on that, and the standing of the journal, you moved to bluff and bluster about his work… and so on.

edit: omit “from your mind”. (It’s very late here; I’ll be surprised if that’s the only typo!)

Mr. Pink,

Did you read your own sentence above? “We have every reason to believe the vaccine will…” That is speculation and faith. Did you read your own evidence: “However, both vaccines may provide sufficient immunogenicity to confer long-term protection.” That is hardly evidence supporting a positive statement like “every reason”.

I think you have been snared by the Nirvana fallacy. By “every reason” I mean that the available evidence is consistent with our expectations that HPV vaccines will provide long term protection against cervical and other cancers. Scientific papers use careful language to avoid making any statements that cannot be directly supported by their contents, which sometimes provides wriggle room for people (like you) to claim that something is not proven when for all practical intents and purposes it is. In real life we have to look at all the available evidence and make decisions based on that evidence. In my opinion the evidence is more than adequate to support universal HPV vaccination.

Public health decisions like this are always a gamble to some extent. If we waited until clinical trials had gone on for decades to see what actual reduction in cervical and other cancers HPV vaccines deliver, that would also be a gamble, one that would likely result in numerous unnecessary cases of cancer and some deaths.

You also said “It has been proven”. No one running clinical trials uses definitive language like that. This is medicine, not mathematics.

This is a blog, not a scientific paper, and I’m not running a clinical trial. The evidence shows beyond any reasonable doubt that HPV vaccines greatly reduce the incidence of precancerous cervical lesions. That’s enough for me to happily use the word “proven” in the sense of “demonstrated by evidence or argument”, not in the mathematical, absolute sense of the word. The evidence also shows beyond any reasonable doubt that the presence of precancerous cervical lesions is predictive of cervical cancer. It is not a large leap of faith or speculation to deduce that HPV vaccines will prevent cervical and other cancers.

As for the evidence itself, it clearly does not study the desired endpoint which is cervical cancer and it only studies a subset of cervical lesions. Either one of these is enough to exclude it as high qualify, but both make it a no-brainer.

There is a huge body of evidence, all of which is consistent with HPV causing cancer, and HPV vaccines preventing both HPV infection and cancer. That’s what makes it a no-brainer. All I see from you is special pleading.

Targeted study from pharmaceutical trials almost never translate to population reality regarding efficacy or safety. It is especially true with vaccination as the time between the shot and the measured outcome increases. Evidence dictates it would be extraordinary if reality matched the outcomes outlined in the narrow study you provided.

I grabbed that “narrow study” more or less at random; there are plenty of other studies that support my position. Even if the effectiveness of these vaccines was half that found in clinical trials, they would still be well worth using as a means of reducing morbidity and mortality.

Your evidence does not and can not consider serotype replacement, long term efficacy, or failure cases. Think about it, a tiny percentage of women get cervical cancer but many get HPV infections. Only repeated infection from the same strain ultimately results in cervical cancer.

Do you have any evidence to support that statement? I thought the latest idea is that persistent latent, not repeated, infection leads to cancer. Prevention of the initial infection by vaccination would prevent that.

So why are some very small percentage of women’s immune systems not able to prevent subsequent infection of the same strain? We don’t know and I find it highly suspect to assume that a woman suffering from an immune system problem that results in persistent infection from the same strain (i.e. they don’t develop immunity), will somehow develop long term immunity from a vaccine which relies on a similar mechanism.

You are making a series of leaps of faith here. Repeated infection? Immune system problem? As I understand it, natural infection does not induce long term immunity as reliably as the vaccine does. The reduction in precancerous changes seen after vaccination strongly suggests it will also prevent cancer.

The key point here, is that you and I are both speculating. That’s because as I stated earlier, there is no high quality evidence to support the hypothesis that mass HPV vaccination will reduce the incidence of cervical cancer in the population primarily because the cerivcal cancer outcomes can’t be studied yet. Until then, it’s just a big clinical trial being run at the population level and no scientist worth their salt uses definitive language about the outcome of a clinical trial before the end point data is collected, let alone analyzed.

We never have the luxury of certainty in the arena of public health. The evidence is always incomplete. If we waited for evidence of high enough quality to satisfy the antivaxxers we would still have thousands dying of smallpox, polio and measles. It’s true this is a gamble, but it is a very safe one in my opinion.

It’s funny you claim to express opinion yet what you said was worded as a statement of fact. Why don’t you go re-read your paragraph and see how much is worded as an opinion?

I think it is quite obvious that this sentence, “He knows perfectly well he is being used as a propaganda tool by people whose beliefs about HPV vaccines are already fixed and who are only interested in evidence that supports them, no matter how reliable it is”, is my opinion. I can’t offer any citations to support what I wrote about Lee’s motivations, I can only state what conclusions I have come to based on what I have read.

But it’s OK, I’ll let you shift the goalpost. Here is my modified response: You showed your true colors with that opinion.

My true colors? If you mean I support the public health decisions taken in many countries around the world regarding HPV vaccination, then yes those are my true colors.

Post marketing surveillance is severely limited (ask dingo as s/he is bursting to talk about it), so there is no need to fake it. As for regulatory trials, no need to fake them either (unless you have something as bad as vioxx).

I disagree. There is plenty of post-marketing evidence to suggest HPV vaccines are remarkably safe and effective. When you consider that they are made using genetically engineered baker’s yeast and they contain nothing that was ever part of a pathogen, their safety is to be expected.

@Me “Are you part of the population who have expertise in HPV genotyping? If so, where and how did you come by this expertise? How do you use genotyping in your daily life?”

Do you have a point to make about the case report? The big outstanding question right now is: How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair? Many here say Dr Lee is wrong about his assertion in the report, but not one of them will answer the question. Funny that.

No, I’m part of the 99.999%. My background isn’t this field, or any other medical field. I’m not qualified to make points about this case report, or any other medical issue. I mostly sit in the corner and read. I doubt that in the 5 years or so I’ve been reading RI that I’ve commented as many times total as you have in this one thread. I’m here for my education and amusement only, not to discuss topics in which I only have a basic understanding.

I know that argument from authority isn’t proof of anything. However, expert opinions are valid data points, and I do consider them. Our host has some experience in genotyping, and has stated why he believes Dr. Lee is using the wrong tool for the job, and incorrectly interpreting the results. You seem to take exception to this, and I was wondering what in your experience has led you to this conclusion.

So Mr Pink answered Johnny’s question with a non-sequitor. How surprising (NOT).
Listen, Pink. If you’re going to dismiss our criticisms of the paper on the basis that we don’t have the expertise to interpret it, then we have the right to ask if you are an expert in the field of genotyping.
You can’t have it both ways.

@Narad “This is a blindly stupid remark to the extent that it’s comprehensible at all. The default assumption is traditionally against preemption.”

Only if you read a press release, otherwise you would see the direct link between drug warning labels, preemption, tort law, and FDA regulation regarding the safety of pharmaceuticals. Apparently, the FDA also didn’t get your memo because their position over three decades and especially since 2006 was to insist on preemption. A ruling against preemption means the court did not place the FDA as the sole gatekeeper of public safety and allowed state tort to continue. From the ruling: “State tort law will sometimes help the Food and Drug Administration (FDA) “uncover unknown drug hazards and [encourage] drug manufacturers to disclose safety risks.”” The reasoning and impact of what was written in the ruling go far beyond labeling and are pertinent here contrary to your assertion. The briefs are completely pertinent here, especially the one from the NEJM. It contained a lot of well researched and referenced evidence regarding the inability of the FDA to effectively regulate and monitor drug safety because they rely so heavily on the manufacturer for information and expertise.

@dingo199 ” I just thought it apposite[sic] to contrast your blind faith in VAERS with your decrial of other more reliable vaccine safety studies.”

Your strawman again. I didn’t put any faith in VAERS, let alone blind faith. I said the records would cause more alarm than this case report. If you want to contrast blind faith in VAERS with vaccine safety studies, then go ahead, but you will be arguing with yourself. You should check out post 547 though, because Krebiozen is holding up VAERS as quality post marketing evidence. Go go go.

@dingo199 “I’ve no need to comment on the case report, Mr Pinkie.”

That pretty much says it all dingo199.

@lw “expertise in HPV genotyping specifically doesn’t seem required, but expertise in using PCR and genotyping in general would be. Mr Pink has not offered evidence that HPV is so uniquely different from all other viruses in existence that expertise with other viruses cannot offer an understanding of HPV.”

Why don’t you actually discuss the point being made there then? If you think a greater percentage of the population will find and think they comprehend the case report, tell me what that percentage is. Why don’t you give me a better number than 0.001%? Is it 0.01% or 0.0154%, or even 1%? Then you can tell me how that compares to the percentage of the population that will read and be alarmed by VAERs entries. Then, and only if there is a substantial difference from the number I gave compared to VAERS will you have a pertinent point to make. So what are better percentages in your mind?

@Julian Frost “So Mr Pink answered Johnny’s question with a non-sequitor.”

How appropriate that you’re talking about non sequitor assertions. Last time you were here #403 insisting in some convoluted argument that Dr Lee didn’t even find HPV DNA fragments (“There is NO PROOF that what Sin Hang Lee found was HPV DNA”). Why don’t you explain to everyone here how one can get a full 184 bp HPV L1 gene DNA sequence which was a 100% match for the HPV-16 sequence stored in GenBank. and somehow not have found HPV DNA? I’m sure we would all love to hear your logical explanation for that one.

@bimler “MrPink@472 That’s a major analogy fail at the most basic level”

I’ll use Narads words here “It is a veritable geyser of irony.” @472 is the post where I asked you the last question you ran away from, not a discussion of analogies. That “lack of effort” that’s depressing you must be your own or Krebiozen’s shoddy evidence. Since you so conveniently brought it up again, why don’t we go back to that critical question before we open up another tangent of yours: How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

@Grant “Still trying to foist this particular twist and bait on me?”

You forget so quickly that you’re the one who foisted it upon yourself… twice. (comments 410 and 447) As for taking bait, you’ve done that many times according to your own line of argument which you insist on maintaining. This would be another example in your world.

@Grant “I suppose could “demand” that you address the points made there in the way that you are “demanding” things of me, but really it’s your choice not to engage with it if you don’t want to.”

You are the one who provided a document “published” (certainly not by Narad’s standards) prior to the case report and then claimed it is relevant. And yet, you refuse or can’t quote a single section from it that is relevant to the case report. You can’t even explain why these “experts” were absent from the investigation when something could have been put on the official record. Your attempts to make it relevant have been a spectacular failure.

@Grant “Like anyone here I don’t “have” to reply to you, never mind address particular things that you would like others to. You don’t get to dictate what others “must” do. Similarly, my not replying on any one thing doesn’t mean a thing.”

And here I thought this was a kangaroo court of sorts and you would be forced to answer. I guess you can wax poetic all day and night without addressing anything real. That’s a real bonus for you.

@Grant “You seem to be arguing that COIs can only about money (something I’ve seen anti-vaccine proponents say). SaneVax said they commissioned and sponsored the study: that is the issue.”

No, those are your words. Why don’t you articulate why commissioning studies is an issue? Are you proposing that all commissioned studies should be casually dismissed without ever evaluating the content? As for other issues, I have no doubt you have many more but they must be secret or really dumb because you vaguely allude to them but say nothing of substance. You seem to have an endless list of issues external to the science itself that are problematic for you. Doesn’t it seem even a little strange to you that still refuse to talk in any detail about the report itself? Finally, it’s worth reminding you that the major bone of contention here still seems to be the assertion about non-B conformation. Since you’ve expressed confidence about your knowledge of such things, it should be a trivial thing for you to take a run at the question: How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

@Krebiozen

@Krebiozen: “In real life we have to look at all the available evidence and make decisions based on that evidence.”
“Public health decisions like this are always a gamble to some extent.”

That’s a vast over simplification. You also have to consider the quality of the evidence, and identify what evidence is missing. Public health should only play when the odds are heavily weighted in its favor and there is a good prospect for a positive ROI and that requires serious high quality evidence. Making long term public health decisions based on only on weak evidence is foolish and generally leads to wasted money, just like this initiative has already started doing.

@Krebiozen: “The evidence shows beyond any reasonable doubt that HPV vaccines greatly reduce the incidence of precancerous cervical lesions. That’s enough for me to happily use the word “proven” in the sense of “demonstrated by evidence or argument”, not in the mathematical, absolute sense of the word.”

I disagree. To use the words “beyond any reasonable doubt” requires results from a systematic review. There are also pockets of problematic results showing up in both the original and later trials. I can only guess you might be referring to the regulatory FUTURE I and II trials which only demonstrated significant efficacy for grade 2 cervical intraepithelial neoplasia. Unfortunately, grade 3 cervical intraepithelial neoplasia is the one that has the strongest potential to be invasive and no efficacy was demonstrated by the vaccine (Sawaya et al. “HPV Vaccination — More Answers, More Questions”, NEJM May 10, 2007). To quote:

With grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ as the outcome,
the difference in risk so far appears to be modest: … The absolute risk difference of 0.8% indicates that 129 women would need to be vaccinated in order to prevent one case of grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ occurring during this period. If grade 3 cervical intraepithelial neoplasia or adenocarcinoma in situ were the most relevant outcome, evidence was insufficient to infer the effectiveness of vaccination.

To put your confidence in even more perspective, this is the first “cancer” vaccine ever trialed. No scientist worth their salt pronounces success before the first clinical trial generates any data. Your words do not come even close to accurately representing the state of the evidence.

@Krebiozen: “Even if the effectiveness of these vaccines was half that found in clinical trials, they would still be well worth using as a means of reducing morbidity and mortality.”

Did your analysis include the costs of ADRs and the increased risk among certain groups? From earlier, 129 vaccinations are required to prevent one case of the surrogate outcome. That’s not a great ratio to start with. Please reference your financial model. Extraordinary statements require at least a shred of evidence no?

@Krebiozen: “This is a blog, not a scientific paper, and I’m not running a clinical trial.”

That’s a great explanation for why you’re using inappropriate and inaccurate language. It doesn’t change the fact that it’s wrong and inappropriate.

@Krebiozen: “All I see from you is special pleading.”

Pointing out that you only have evidence for surrogate outcomes is not pleading. Neither is pointing to a lack of evidence to validate the assumptions inherent in the choice of surrogate outcomes.

@Krebiozen: You are making a series of leaps of faith here. Repeated infection? Immune system problem? As I understand it, natural infection does not induce long term immunity as reliably as the vaccine does. The reduction in precancerous changes seen after vaccination strongly suggests it will also prevent cancer.

I quote Ian Frazer, one of the pioneers of the vaccine.

A substantial proportion of men in the Middle Park study were immunocompromised, meaning that they had reduced numbers of helper T cells, and we observed that they did not easily get rid of genital warts. This observation led me to develop an interest in the immunobiology of HPV infection, which at that time was essentially unknown territory.

Immune system problems related to HPV infection is clearly not a faith based assertion.

From Spinosa JP, Riva C, Biollaz J, “Cancer Letters”, doi:10.1016/j.canlet.2011.01.024

We have read with great interest the article by LL Villa “HPV prophylactic vaccination: The first years and what to expect from now”… We note however that this contribution is missing two basic informations to get a picture as complete as possible of the effectiveness and safety of these vaccines and particularly of the Gardasil”. First Villa did not cite figures effectiveness of vaccines in per protocol groups against CIN2/3 caused by all HPV. These numbers are absolutely essential to know the real capacity of these vaccines to prevent cancer of the cervix because of the theoretical possibility of viral replacement. The data reported by Merck to the FDAin 2006 [lJ show those results exist. An analysis of the three main studies (Table 26) of efficacy against CIN2/3 or worse due to any HPV type among the per protocol population. and who had normal Pap smears at day 1 confirmed an average observed reduction of “only” 20.5%.not yet published in medical literature. Second we regret that Villa does not mention the possible increased risk, for women already infected with strains targeted by vaccines, of developing CIN2/3 in case of vaccination. Figures provided by Merck to the FDA[1] suggest that such risk exists. The May, 18. 2006 the FDAVaccines and Related Biological Products Advisory Committee (VRBPAC)report concluded that an “additional item for discussion will be the finding in the baseline PCR positive and seropositive subgroup of study 013 of an increased rate of aN 2/3 or worse due to the relevant HPV vaccine types among Gardasil recipients”. These risks have never been openly discussed in medical literature. The numbers cited in the 2010 publication of Mufioz et al, reinforce the hypothesis of the existence of such a risk for women with positive high risk HPV at the time of vaccination.

Here they are discussing data showing viral replacement problems and issues of increased risk among pockets of vaccinated individuals. Apparently, it’s not faith based either.

Have you read the results of the 2012 ATHENA HPV study? (Wright T, “The ATHENA human papillomavirus study: design, methods, and baseline results) This real life evidence shows a remarkably low vaccine efficacy rate against HPV-16 and HPV-18 let alone very concerning signs of increased risk for hrHPV (high risk HPV) in the vaccinated group. Why don’t you plug those numbers into your cost/benefit model and tell us all how it comes out? I highly suspect it will be a negative ROI.

@Krebiozen: “I grabbed that “narrow study” more or less at random; there are plenty of other studies that support my position.”

Bimler was complaining about a depressing lack of effort in arguments. He must have been referring to you. Randomly grabbing low quality evidence to support your point is either trolling or shooting yourself in the foot. You have now successfully backpedalled to an evidence free position.

@Krebiozen: “We never have the luxury of certainty in the arena of public health. The evidence is always incomplete.”

You missed the point. You can’t use definitive statements of success while the clinical trial is still running and the data hasn’t even started coming in yet. You’re just making excuses for bad decisions by public health. They’ve already botched the delivery of the vaccine which makes the whole program cost ineffective. That’s usually considered a failure for public health.

@Krebiozen: “I think it is quite obvious that this sentence … is my opinion”

But it was worded as a statement of fact and as such it was justifiable for me to treat it like an argument.

@Krebiozen: “My true colors? If you mean I support the public health decisions taken in many countries around the world regarding HPV vaccination, then yes those are my true colors.”

No. I meant by swallowing whole the bias, propaganda, and misinformation being distributed here.

@Krebiozen: “I disagree. There is plenty of post-marketing evidence to suggest HPV vaccines are remarkably safe and effective.”

Can I introduce you to dingo199? Hey Dingo, here is someone who is actually pointing to VAERS as evidence of effective post marketing surveillance. What do you have to say about that? I’m sure you can tell us the number of reactions that actually get reported to passive post marketing surveillance systems right?

As for pointing to a CDC website as evidence? The CDC used to say ~30,000 people in the US died every year from the flu which turned out to be very wrong. When H1N1 came along that number suddenly dropped to a fraction of that. Their websites are not a reliable reference or evidence of anything in particular. Until you produce some actual evidence your words are empty. I’ll even read it if it’s from a SCIRP journal although Narad might go ape on you if it is.

@Johnny “Our host has some experience in genotyping, and has stated why he believes Dr. Lee is using the wrong tool for the job, and incorrectly interpreting the results.”

Hi Johnny. Experience genotyping with PCR does not readily convert into expertise for finding HPV DNA mixed with human genomic DNA. You can find basic instructions for PCR on a web site like this: https://www.roche-applied-science.com/sis/amplification/pcr_amplification_050400.html. You will find no such instructions to help you sort through the noise of human genomic DNA and find a small amount in post mortem samples.

Our host did not provide any references to back up his assertion that nested PCR was an inappropriate tool. I already provided a reference to show that it was used in the industry as a valid tool for HPV genotyping. Our host complains about the high risk of nested PCR generating junk, but Dr Lee was able to sequence a full 184 bp HPV L1 gene DNA sequence which was a 100% match for the HPV-16 sequence stored in GenBank. You won’t ever get that from junk so that argument goes out the window.

Our host specifically says he doesn’t understand the approach, which leads me to believe he does not have experience genotyping HPV DNA fragments mixed with human genomic DNA. He complains about “fiddling” with primers but that is hardly a good reason to disregard the results. It’s true, you won’t “fiddle” if you’re doing basic genotyping but that is why the specific expertise matters. After all that though, the “fiddling” did not generate junk because as I noted above, it generated a sequence that matched 100% and the reasons for the fiddling were described in the case report.

Our host wants a population study, which is a good thing and a logical next step, but it doesn’t invalidate the results of a case study especially one with such a unique finding. This HPV-16 L1 DNA fragment in non-B conformation has no plausible explanation for existing in the general population or existing at all unless you consider the vaccine manufacturing process.

Several posters here disagree with the assertion that the fragment was in non-B conformation. However, none of them will answer the question to provide an alternate characterization that explains the test results. Several posters here think that the lack of a population study invalidates the claim of uniqueness. However, none of them — including the host — has proposed a plausible explanation for how a unique DNA fragment in non-B conformation would have gotten into the autopsy tissue let alone the general population without having been discovered by the many HPV researchers. Dr Lee, provides a very plausible explanation for the conformational change because aluminum is known to cause this sort of thing. (the explanation and references are in the case report)

Our host complains that Dr Lee should have looked for a more vaccine specific sequence. Our host’s suggestion to find a DNA “that encompasses part of the L1 gene, the promoter region used, and pGAL110 sequence that is directly attached to the insert.” is based on a whole host of assumptions. For instance, it assumes the entire circle of the L1 gene, the promoter region and the pGAL110 that were inserted into the yeast as one piece are still freely floating in the patient’s spleen cells. Frankly, that’s an armchair researcher assumption. Even the FDA was smart enought to say “HPV L1 gene DNA fragments” were in the vaccine, not the L1 gene attached to other parts.

When the original findings of DNA fragments in the vaccine were announced, our host went on about many of the same things. He expressed extreme skepticism about the methodology of nested PCR (it produces junk), he expressed doubt that the fragments existed and he wanted published details on the methods. To quote the host: “Maybe Dr. Lee should be come a homeopath. He seems to think that the more the HPV DNA is diluted, the stronger it becomes.”

More than a year later he has confirmation from the FDA about the findings and he has the methods clearly published for all to read. (It’s worth noting that the FDA confirmed the finding a while after Dr Lee announced his findings, which means it’s likely they had to do some testing themselves) Even still, our host he complains about the methodology again, and about most of the same things, except now he expects a population study instead of a case report. It seems pretty clear to me, that any potential issue with this vaccine will be met with outright hostility by our host.

I am very interested which specific argument of his you find compelling that hasn’t yet been addressed somewhere in these comments.

@Mr Pink

Making long term public health decisions based on only on weak evidence is foolish and generally leads to wasted money

Like changing a policy on giving the HPV vaccine on one non-replicated paper by one scientist for instance?

Ah darn it… there should be a ‘based’ between ‘vaccine’ and ‘on’.

Like changing a policy on giving the HPV vaccine *based* on one non-replicated paper by one scientist for instance?

A ruling against preemption means the court did not place the FDA as the sole gatekeeper of public safety and allowed state tort to continue.

You are a buffoon. As I already told you, Levine turned on warning defect. Courts do not “place” anybody as “gatekeeper” of anything. Go read Bruesewitz, come back, and explain why Scalia used a textual analysis. Or, whatever, explain the history of the Boiler Inspection Act and its relationship to the Price-Anderson Act and why Silkwood turned out the way it did.

Or just get your head around the fact that you said something really stupid and still don’t understand why.

Why don’t you articulate why commissioning studies is an issue? Are you proposing that all commissioned studies should be casually dismissed without ever evaluating the content?

Hey, who am I?

Do you really not understand the fallacy of the anecdote? Elsevier created a fraudulent journal just for Merck to publish marketing “science” about Vioxx.

Why on Earth does Mr. Pink even still bother to comment? Anyone reading here will see him contradicting himself left and right – first we should believe that the work has no flaws because it was published in a journal; then we should believe that the choice of a bottom-feeding journal from a known scam operation doesn’t mean anything because it’s the paper that matters. One minute, when it comes to criticizing Lee, one needs to be an expert in genotyping; the next minute, when it comes to defending Lee, it’s suddenly so elitist to even think about the expertise of the person saying “Trust me, all the experts know this is bulletproof.”

Hell, even if I had no idea who was who, all it would take reading this to sway me is Mr. Pink’s comment where he claims that a simple arguendo argument is beyond his comprehension.

@JGC “Mr. Pink, you seem to be assuming I lack sufficient real knowledge and practical lab experience to be able to understand Lee’s publication and identify the logical problems with his claims. That isn’t the case. But let’s assume I was that ignorant of PCR amplification..”

What a bizarre point to make: I must have been wrong in my assumption, but let’s go with it anyways?

If Mr. Pink finds a hypothetical argument which posits a single counter-factual “bizarre,” the best case explanation for why he cannot follow something so simple is that he is a Dunning-Kruger poster child, convinced that he has expertise only because he has insufficient expertise to even recognize expertise. Worst cases, of course, include that he’s simply willing to lie. There is no case that gives Mr. Pink credibility for all the claims he makes.

Why does he still bother? He’s lost. No matter what he says, he cannot change the facts: the burden of proof for Lee’s methodology and results has not been met, and there is no reason, therefore, to give it any credence. Everything Mr. Pink says is an irrelevant distraction from that point. Don’t know why he imagines it can still work.

Why does he still bother? He’s lost. No matter what he says, he cannot change the facts: the burden of proof for Lee’s methodology and results has not been met, and there is no reason, therefore, to give it any credence. Everything Mr. Pink says is an irrelevant distraction from that point. Don’t know why he imagines it can still work.

This is precisely why I stopped responding. There’s really no point in trying to debate with someone who refuses to accept the basic premise that the data, as reported, are not sufficient to draw the conclusions that Lee presents.

Mr. Pink,

Public health should only play when the odds are heavily weighted in its favor and there is a good prospect for a positive ROI and that requires serious high quality evidence. Making long term public health decisions based on only on weak evidence is foolish and generally leads to wasted money, just like this initiative has already started doing.

Clearly you and I disagree on the strength and quality of the evidence for the safety and efficacy of HPV vaccines.

I disagree. To use the words “beyond any reasonable doubt” requires results from a systematic review.

You mean like this systematic review? It looked at 44,000 subjects and concluded:

The vaccines were safe and generally well tolerated. Vaccination of adolescent girls prior to sexual debut appeared to be the most effective public health measure for prevention of cervical diseases and cancer.

You mentioned the FUTURE trials:

I can only guess you might be referring to the regulatory FUTURE I and II trials which only demonstrated significant efficacy for grade 2 cervical intraepithelial neoplasia. Unfortunately, grade 3 cervical intraepithelial neoplasia is the one that has the strongest potential to be invasive and no efficacy was demonstrated by the vaccine

No efficacy could possibly have been demonstrated because there was only one case of grade 3 neoplasia in the entire cohort of almost 12,000 women. Grade 3 cervical intraepithelial neoplasia is rare, so grade 2 is used as a surrogate endpoint, which seems perfectly reasonable since most cases of grade 2 progress to grade 3. As FUTURE II states:

Although prevention of invasive cervical cancer is the main goal of prophylactic HPV vaccination, it is ethically unacceptable to use invasive cancer as the end point in efficacy trials.

You then claim that the vaccine is ineffective, quoting:

With grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ as the outcome, the difference in risk so far appears to be modest: … The absolute risk difference of 0.8% indicates that 129 women would need to be vaccinated in order to prevent one case of grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ occurring during this period. If grade 3 cervical intraepithelial neoplasia or adenocarcinoma in situ were the most relevant outcome, evidence was insufficient to infer the effectiveness of vaccination.

You didn’t mention that these results were for sexually active women many of whom had already been exposed to HPV. As the paper you referred to states:

Within both trials, subgroups of subjects with no evidence of previous exposure to relevant vaccine HPV types were evaluated separately for vaccine efficacy. In these subgroups, efficacy of nearly 100% against all grades of cervical intraepithelial neoplasia and adenocarcinoma in situ related to vaccine HPV types was reported in both trials.

If you accept grade 2 cervical intraepithelial neoplasia as a surrogate endpoint for cervical cancer, it does seem very likely that vaccination before exposure to HPV will prevent both cervical intraepithelial neoplasia and cervical cancer if vaccination occurs before initial exposure.

Did your analysis include the costs of ADRs and the increased risk among certain groups? From earlier, 129 vaccinations are required to prevent one case of the surrogate outcome. That’s not a great ratio to start with. Please reference your financial model. Extraordinary statements require at least a shred of evidence no?

As I pointed out, that ratio is in women who have already been exposed to HPV, which is why Gardasil is recommended in girls and boys before they become sexually active.

@Krebiozen: “This is a blog, not a scientific paper, and I’m not running a clinical trial.”

That’s a great explanation for why you’re using inappropriate and inaccurate language. It doesn’t change the fact that it’s wrong and inappropriate.

You don’t seem to understand that different language and different standards of evidence are appropriate in different contexts. While not wishing to invoke an argument from authority, it does seem that public health authorities all around the world agree with my assessment of the evidence.

You then indirectly suggest, if I follow you, that it is possible that HPV only leads to cervical and other cancers in those with impaired immune systems, so that the vaccine might not protect them from cancer. I don’t see any evidence that the vaccine would not prevent infection in this group, but for the sake of argument let’s assume you are correct. Wouldn’t universal vaccination of people before they are exposed to HPV still reduce the incidence of infection in this immunocompromised group through herd immunity? They can’t become infected if there is no one already infected to give it to them.

You also refer to viral replacement. This is a real possibility, of course, and I don’t doubt that further vaccine development will be necessary to address this. I don’t see the fact that the vaccine mostly protects against the viruses it is designed to protect against as a problem with the vaccine. HPV is a moving target. That doesn’t mean we should give up efforts to dramatically reduce its impact or even eliminate it.

Have you read the results of the 2012 ATHENA HPV study? (Wright T, “The ATHENA human papillomavirus study: design, methods, and baseline results) This real life evidence shows a remarkably low vaccine efficacy rate against HPV-16 and HPV-18 let alone very concerning signs of increased risk for hrHPV (high risk HPV) in the vaccinated group.

The ATHENA study didn’t look at vaccine efficacy, it looked at prevalence of different strains of HPV. Perhaps you are thinking of one of Merck’s studies that showed enhanced risk factors for development of CIN 2/3 or worse in small subgroups that were PCR positive and/or seropositive for the relevant HPV. Subsequent studies have not confirmed that finding, and even if it were replicated it would support early vaccination before exposure to HPV.

Bimler was complaining about a depressing lack of effort in arguments. He must have been referring to you. Randomly grabbing low quality evidence to support your point is either trolling or shooting yourself in the foot. You have now successfully backpedalled to an evidence free position.

Grabbing one piece of evidence from a huge pile that all supports what I am suggesting is hardly an evidence-free position. What I’m saying is that if you don’t like that study, there are plenty more that point to the same conclusions.

You missed the point. You can’t use definitive statements of success while the clinical trial is still running and the data hasn’t even started coming in yet.

You ignore the many clinical trials that have been run and results of which have been published. There is no doubt that the vaccine is highly effective at reducing the incidence of HPV-16 and HPV-18 in those not previously exposed to it. There is very little if any doubt that reducing the incidence of these viral infections will reduce the incidence of cervical and other cancers. Even if your suggested immunodeficiency hypothesis is correct, herd immunity will still reduce the chance of those immunodeficient being exposed to these viruses and will reduce the incidence of cancer.

You’re just making excuses for bad decisions by public health. They’ve already botched the delivery of the vaccine which makes the whole program cost ineffective. That’s usually considered a failure for public health.

That depends on what factors you consider and what time scale. I don’t think it is a bad decision, and I don’t know what you are referring to when you write, “They’ve already botched the delivery of the vaccine”.

No. I meant by swallowing whole the bias, propaganda, and misinformation being distributed here.

The only bias, propaganda and misinformation I see here is coming from you.

Can I introduce you to dingo199? Hey Dingo, here is someone who is actually pointing to VAERS as evidence of effective post marketing surveillance. What do you have to say about that? I’m sure you can tell us the number of reactions that actually get reported to passive post marketing surveillance systems right?

No one has suggested that VAERS isn’t a part of effective post-marketing surveillance, of course it is, but it is only a small part, acting as an early warning system. Assuming that any adverse events reported to VAERS are caused by the vaccine is the error Dingo199 was referring to. The CDC link also discusses VSD which includes rapid cycle analysis, active surveillance which has followed over 600,000 people given HPV vaccines.

As for pointing to a CDC website as evidence? The CDC used to say ~30,000 people in the US died every year from the flu which turned out to be very wrong. When H1N1 came along that number suddenly dropped to a fraction of that. Their websites are not a reliable reference or evidence of anything in particular.

I was pointing to the CDC as evidence that a great deal of post marketing surveillance supports the safety and efficacy of HPV vaccines. Since the CDC run the active surveillance I was referring to I don’t see what better source I could point to. Dismissing the CDC entirely as a reliable source of information does your credibility little good.

Until you produce some actual evidence your words are empty. I’ll even read it if it’s from a SCIRP journal although Narad might go ape on you if it is.

Maybe you could start with the systematic review I linked to above.

@Antaeus Feldspar

Because he knows that he’s been called out on his lies and deceit, knows he’s lost the argument, and the only way he can attempt to cover it up is to state more lies and ad hominems?

On a different note, I admire all of those who have constantly called mr pink out on his lies and pseudoscience. That takes a lot of patience to deal with such a dishonest and persistent person as he/she/it.

@Antaeus “Why on Earth does Mr. Pink even still bother to comment?”

Indeed, I think the question is more pertinent for you. You seem to keep coming back, but the closest thing you were able to articulate about the case report was a strawman about novel methodologies. Do you have any points to make about the case report yet?

@novalox “Because he knows that he’s been called out on his lies and deceit, knows he’s lost the argument, and the only way he can attempt to cover it up is to state more lies and ad hominems?”

Did you cut and paste random words from Orac’s posts during the last month or something? My 5 year old could have come up with better rhetorical insults.

@flip “Like changing a policy on giving the HPV vaccine on one non-replicated paper by one scientist for instance?”

Flip, you shouldn’t worry about the typos, it’s the strawman you should be focused on. Who recommended changing any policies based on the case report? My objection to the policy of mass vaccination is based on a glaring lack of evidence of efficacy in real life situations, not the case report. Even you should be able to keep up with that.

@Krebiozen

“Grabbing one piece of evidence from a huge pile that all supports what I am suggesting is hardly an evidence-free position.”

Evidence fail #1. Making a very broad statement and supporting it with a narrow study doesn’t sound like the smartest way to support your argument. Just sayin.

“You mean like this systematic review? It looked at 44,000 subjects and concluded:”

Evidence fail #2. Those are surrogate outcomes again. I was talking about cervical cancer remember? I also highly doubt that study would even come close to meeting the Cochrane definition of systematic review because all the studies were funded by the manufacturer (all but one from Merck) and thus they all have a risk of bias of the exact same type.

“Since the CDC run the active surveillance I was referring to I don’t see what better source I could point to.”

Evidence fail #3. You said: (comment 547) “There is plenty of post-marketing evidence…” and referenced a website which only contains a single study based on VAERS data. Oops. If you want to claim there is “plenty of post-marketing evidence” of remarkable safety and efficacy, then you must provide a reference to at least a few studies, and they better not all be from VAERS as we know from studies that it will only contain a tiny fraction of the actual adverse events.

“Maybe you could start with the systematic review I linked to above.”

Evidence fail #4. Did you read your own evidence or did you just pick one from Narad’s barrel at random again? You do understand why that so-called systematic review can’t count as evidence of post marketing surveillance right?

“No efficacy could possibly… there was only one case of grade 3 neoplasia in the entire cohort of almost 12,000 women. Grade 3 cervical intraepithelial neoplasia is rare, so grade 2 is used as a surrogate endpoint, which seems perfectly reasonable since most cases of grade 2 progress to grade 3. “

Definition fail. It appears you have redefined the term “most” (let me guess, this is a blog right?) because according to this paper the CIN2 progression rate was 15% (in 3 years) and the regression rate was 70%. (Moscicki AB et al, “Rate of and Risks for Regression of CIN-2 in adolescents and young women”, Obstet Gynecol, March 15, 2011). It looks like “most” CIN2 regresses. Given that there is ongoing debate as to the validity of CIN2 as a reliable surrogate, the term “Perfectly reasonable” is also grossly misleading. http://jnci.oxfordjournals.org/content/96/4/250.long

By now you should also be asking why one spends so much money on mass vaccination when the best surrogate outcome is so rare and the disease only manifests in a fraction of those cases.

“You then claim that the vaccine is ineffective, quoting:”

Comprehension fail. I never claimed it was ineffective, I quoted the efficacy rate from the letter.

“As I pointed out, that ratio is in women who have already been exposed to HPV, which is why Gardasil is recommended in girls and boys before they become sexually active.”

From Merck’s own website: “GARDASIL is a vaccine indicated in females 9 through 26 years of age …” “GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.” No mention of sexual activity there. Age 26 is pretty old to assume virginity unless you’re living on a different planet. You can’t have it both ways, if you want to exclude the results, then you better make prior sexual activity a contraindication or do HPV testing prior to vaccination. Until then, those results are completely pertinent.

“This is a real possibility, of course, and I don’t doubt that further vaccine development will be necessary to address this.”

Given the long term nature of this disease, if the viral replacement happens too quickly the vaccine will be useless. That would at least double the cost or worse. I notice you totally avoided bringing any evidence outlining your extraordinary cost calculation to the table. Your claim was that half the estimated efficacy rate is still easily cost effective. Without seeing your evidence, I counter that any pharmaceutical company that prices their product to leave 50% of their potential revenue on the table is some dumb. Think about it.

“The ATHENA study didn’t look at vaccine efficacy, it looked at prevalence of different strains of HPV. Perhaps you are thinking of one of Merck’s studies that showed enhanced risk factors for development of CIN 2/3 or worse in small subgroups that were PCR positive and/or seropositive for the relevant HPV.”

No, I was looking at the Athena 2012 study data. They break down HPV genotype prevalence and show the difference between vaccinated and unvaccinated groups. The marginal or non-existent difference in HPV-16 or HPV-18 rates between vaccinated and unvaccinated groups is pretty indicative of vaccine failure unless you have some other definition. The increased prevalence of hrHPV in vaccinated individuals doesn’t bode well for your surrogate outcomes, since as you noted yourself, the success of the program is predicated on preventing HPV infection in the first place.

“You ignore the many clinical trials that have been run and results of which have been published.”

I didn’t ignore them. I pointed out that they all use surrogate outcomes and that the trial which will actually measure the endpoint (real usage) is still running with no data to report yet.

“I don’t know what you are referring to when you write, “They’ve already botched the delivery of the vaccine”.”

Cervical cancer is primarily a disease of the poor. In the US, the cervical cancer mortality rates in the poor states can be double that of the wealthy ones. The cost justification of the program assumes that the poor get the vaccine. (Kim JJ, Goldie SJ. Health and economic implications of HPV vaccination in the United States. N Engl J Med 2008; 359: 821–32.)

Unfortunately health care distribution in the US is skewed to the wealthy and the vaccine distribution is the same making calling into question the cost justification.
Bach P, “Gardasil: from bench, to bedside, to blunder”, The Lancet, Vol 375 March 20, 2010; 963

PS: The evidence in there also blows your prior assertion that half the efficacy easily cost justifies the program.

“Dismissing the CDC entirely as a reliable source of information does your credibility little good.”
Your strawman about the CDC doesn’t do your credibility any good. I didn’t state the CDC was an unqualified unreliable source of information. I stated that the CDC websites are not considered evidence. Big difference.

@AdamG “This is precisely why I stopped responding. There’s really no point in trying to debate with someone who refuses to accept the basic premise that the data, as reported, are not sufficient to draw the conclusions that Lee presents.”

You can stop whining now because look what showed up here: http://www.scirp.org/journal/abc/
Perhaps those crafty editors of SCIRP purposely published the two closely related articles by the same auther in two sister journals to generate more publicity among people who actually want to read new science.

Find the article: Lee SH. Topological conformational changes of human papillomavirus (HPV) DNA bound to an insoluble aluminum salt – a study by low temperature PCR. Advances in Biological Chemistry 2013; 3: 76-85.

You insist that Dr Lee is wrong in his conclusion, based merely on your assertion. Yet, you refuse to provide your own explanation for the test results. How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

If you want to question Dr Lee’s expertise, then I suggest you first read the two reports very carefully. Then compare Dr. Lee’s PCR and the PCR you might get from your sales rep at Roche (I posted a link in comment 555). Could that sales rep teach you to perform a 1.3 x 10(exp36) fold amplification of a template for Sanger sequencing like Dr Lee did? Just do the math. If you don’t get it, then you aren’t really in the field. And he didn’t get junk because he sequenced a full 184bp HPV L1 Gene DNA that matched HPV-16 in GenBank 100%.

Perhaps those crafty editors of SCIRP purposely published the two closely related articles by the same auther in two sister journals to generate more publicity among people who actually want to read new science.

Oh, the irony. Publishing in journals that don’t even have impact factors sure is a great way to generate publicity!

From the conclusions section of the new article:

Naked HPV L1 gene DNA fragments bound to Al3+ in solid phase by ligand exchange have acquired a non-B- conformation.

If you truly believe that this paper presents sufficient evidence to justify this conclusion, I have no interest in discussing this further.

How do you characterize an HPV-16 L1 gene DNA fragment matched by sequencing after PCR amplification, that is not amplifiable by the commonly used degenerate consensus GP5/MY09 or GP6/MY11 PCR primer pair?

Also, do you really think this is some kind of ‘gotcha’ question that proves your point? Dude, it’s called a Bioanalyzer.

@mr pink

Hi. Try again with your petty insults, you really are entertaining but it does get lost in your wall of irrelevant text, you know.

Of course, I have to make my posts as simple for you to read, since it seems that you have major problems in basic logic and all it seems is that you cannot grasp a basic argument, instead relying on insults, putting words in people’s mouths, and generally spewing nonsense.

Besides, why should we listen to you, who seems to be impervious to all logical and rational thinking. Your lack of logic in your posts is quite frightening if you really claim to be a scientist.

I mean, who would want to trust someone with such an astonishing lack of basic logic.

But of course, I’ll be waiting for you to attempt another pathetic attempt at insult. It should be amusing to see what comes from your infantile mind. I should get at least a little chuckle from your nonsense.

Cervical cancer is primarily a disease of the poor. In the US, the cervical cancer mortality rates in the poor states can be double that of the wealthy ones.

This may well be the most stupid thing you’ve put on offer yet.

(And just to be clear, it represents an immediate leap to the well-known antivax morbidity–mortality conflation.)

Perhaps those crafty editors of SCIRP purposely published the two closely related articles by the same auther in two sister journals to generate more publicity among people who actually want to read new science.

Perhaps they (or somebody) should be notified that the listed affiliation is fraudulent. Note the received date. I suppose it’s time to check whether he self-plagiarized.

Out of general curiousity… is there any record of anyone other than Lee using his LoTemp™ PCR technology? His press releases document his attempts to shake down the FDA and his allegations against the NEJM as part of the conspiracy to suppress him — the litigation also being covered on his News Page — but the absence of customer testimonials is surprising.

Mr. Pink,

As I have already explained, surrogate endpoints have to be used as it would be unethical to use invasive cancer as an endpoint, and in any case cervical cancer is rare. This means that a clinical trial would require either impractically large numbers or be run for an impractically long period to have sufficient statistical power if it used invasive cervical cancer as an endpoint. That leaves us with a choice. We can run larger studies for longer and leave millions vulnerable to cancer, or we can trust the studies using surrogate markers for cervical cancer and assume that if the vaccine prevents HPV infection and reduces the incidence of these surrogate markers it will also reduce the incidence of cervical cancer. Both the WHO and the FDA consider CIN-2 and CIN-3 to be valid surrogate endpoints to assess the effectiveness of HPV vaccines.

Public health authorities in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, Israel, Ireland, Italy, Kenya, Latvia, Luxembourg, Macedonia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland and the United Kingdom as well as the United States have approved the vaccine with the great majority providing public funding, which suggests that public health authorities in these countries regard the vaccine as economically viable. If you are really unaware of the body of evidence that these decisions are based on, or are prepared to dismiss it because it is based on surrogate markers or suffers from bias because some of the studies are sponsored by vaccine manufacturers, there isn’t much left to discuss.

You ignore the VSD and rapid cycle analysis referred to on the CDC page I linked to that has actively surveilled over 600,000 vaccine recipients and the large body of evidence that supports the efficacy and safety of the vaccines.

I did make an error about CIN-2 progression – I read this “The annual regression rate of CIN-2 in adult women is estimated to range from 15 to 23%, with up to 55% regressing by 4–6 years.” and misinterpreted it. Even so, all cervical cancer passes through stages 1 through 3, making it a reasonable assumption that if you reduce the incidence of stage 1 that will also reduce the incidence of cervical cancer, either directly through preventing initial infection, through herd immunity or both.

Given that there is ongoing debate as to the validity of CIN2 as a reliable surrogate, the term “Perfectly reasonable” is also grossly misleading.

It is you who is being misleading here, since the paper you link to debates whether CIN-2 is a useful surrogate for cervical cancer in making treatment decisions, not whether it is a useful surrogate in looking at vaccine efficacy.

By now you should also be asking why one spends so much money on mass vaccination when the best surrogate outcome is so rare and the disease only manifests in a fraction of those cases.

Are you really suggesting that a disease that kills hundreds of thousands of women globally every year is not worth attempting to control? The vaccine appears to be safe and effective and can be expected to save a great deal of anxiety (as any woman who has had a positive pap screen can tell you), suffering, and several deaths over the next few decades. There is an argument about cost benefit ratios to be made here, as there always is in public health. I disagree with your implication that it is not cost effective, as do public health authorities in the countries I listed above. You are the one with the dissenting opinion here.

Comprehension fail. I never claimed it was ineffective, I quoted the efficacy rate from the letter.

You quoted the efficacy rate in women who are sexually active and had already been exposed to HPV. Not surprisingly the vaccine isn’t as good at preventing infection in those who have already been infected as it is in those who have not.

From Merck’s own website: “GARDASIL is a vaccine indicated in females 9 through 26 years of age …” “GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.” No mention of sexual activity there. Age 26 is pretty old to assume virginity unless you’re living on a different planet. You can’t have it both ways, if you want to exclude the results, then you better make prior sexual activity a contraindication or do HPV testing prior to vaccination. Until then, those results are completely pertinent.

You do have a interesting habit of distorting information. Why does something have to be either contraindicated or recommended? Why does “9 through 26 years of age” automatically mean 26 years of age? Clearly the vaccine is more effective in people who have not been exposed to the virus, though it is still useful in those who have not. The vaccine is a component of the US Recommended Pediatric and Adolescent Immunization Schedule. As the CDC website states:

FDA licensed Gardasil in 2006. Gardasil is recommended for 11- and 12 year-old girls, and also females 13 through 26-year-old who were not previously vaccinated.

On viral replacement:

Given the long term nature of this disease, if the viral replacement happens too quickly the vaccine will be useless. That would at least double the cost or worse. I notice you totally avoided bringing any evidence outlining your extraordinary cost calculation to the table. Your claim was that half the estimated efficacy rate is still easily cost effective. Without seeing your evidence, I counter that any pharmaceutical company that prices their product to leave 50% of their potential revenue on the table is some dumb. Think about it.

In strict economic terms that may be true, but this completely ignores any costs of human suffering. The vaccine is almost 100% effective at preventing HPV-16 and HPV-18 in those not previously exposed, and vaccines that protect against other strains are being developed. I think this is a public health goal well worth pursuing. In the long term it might even be possible to eliminate HPV entirely. There are several papers that discuss the pharmacoeconomics of the vaccine if anyone is interested for example here.

“The ATHENA study didn’t look at vaccine efficacy, it looked at prevalence of different strains of HPV. Perhaps you are thinking of one of Merck’s studies that showed enhanced risk factors for development of CIN 2/3 or worse in small subgroups that were PCR positive and/or seropositive for the relevant HPV.”

No, I was looking at the Athena 2012 study data. They break down HPV genotype prevalence and show the difference between vaccinated and unvaccinated groups.

Do you have a link? ATHENA was not designed to assess vaccine efficacy and I can only find references to a sub-group analysis looking at vaccinated and unvaccinated but not the data itself.

The increased prevalence of hrHPV in vaccinated individuals doesn’t bode well for your surrogate outcomes, since as you noted yourself, the success of the program is predicated on preventing HPV infection in the first place.

The only place I can find these results is in women already exposed to HPV in one of Merck’s trials which has not been replicated.

Your strawman about the CDC doesn’t do your credibility any good. I didn’t state the CDC was an unqualified unreliable source of information. I stated that the CDC websites are not considered evidence. Big difference.

That’s not true. You claimed that because the CDC got influenza mortality wrong we can’t believe what they have to say about HPV vaccine safety and efficacy. If that’s not stating that the CDC is an unqualified unreliable source I don’t know what is.

I love 10^36 fold amplification. That gives you what, a billion tons from a single 10k DNA fragment?

Cervical cancer is primarily a disease of the poor. In the US, the cervical cancer mortality rates in the poor states can be double that of the wealthy ones.

No…cervical cancer does not recognize socioeconomic barriers. That mortality rates are higher among the poor in the US is an indicator of access to treatment, something that should be apparent to anyone who monitors health trends in this country.

@Mr Pink

@flip “Like changing a policy on giving the HPV vaccine on one non-replicated paper by one scientist for instance?”

Flip, you shouldn’t worry about the typos, it’s the strawman you should be focused on. Who recommended changing any policies based on the case report? My objection to the policy of mass vaccination is based on a glaring lack of evidence of efficacy in real life situations, not the case report. Even you should be able to keep up with that.

So you’d agree with me that Lee’s paper is pretty useless until it’s replicated then? – Even assuming the contents of it are valid.

the two closely related articles by the same auther in two sister journals…
Find the article: Lee SH. …. Advances in Biological Chemistry 2013; 3: 76-85.

I saw no evidential value when Lee reported his claims on a no-peer-review, no-editorial-standards website, but now that he has paid again to have basically the same article appear a second time on another of the network’s websites, I am totally convinced!

Then compare Dr. Lee’s PCR and the PCR you might get from your sales rep at Roche (I posted a link in comment 555). Could that sales rep teach you to perform a 1.3 x 10(exp36) fold amplification of a template for Sanger sequencing like Dr Lee did?

This is certainly a change from the original argument, that we shouldn’t question Lee’s claims because he is the accepted authority in the field. Now we shouldn’t question Lee’s claims because he’s a brilliant outsider, reporting amplification rates orders of magnitude better than anyone else.

Between extravagant claims like this, and the history of litigation described on the HiFiDNA website, I don’t understand why Lee is not finding any customers for his LoTemp™ technology.

the litigation also being covered on his News Page

This bit is hysterically funny if one knows what the CSE actually is:

Connecticut Pathologist Sin Hang Lee, MD, has filed a complaint with the international Council of Science Editors alleging the prestigious New England Journal of Medicine

Vis-a-vis Lee’s history of litigation, I momentarily forgot his earlier battle with the FDA over his treat-cancer-with-green-tea scam.

Readers of previous threads will recall that the FDA insisted on Lee ceasing to advertise the magical green tea as preventing cancer, and modifying his claims with appropriate caveats:
http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm301644.htm
Lee’s response was to spin his product as FDA-approved: “the Only Green Tea with FDA Qualified Health Claim”.

(I think I put their style manual in the recycling when I came across “H π region” [yes, pi] under the putative astronomical notation. [For those unfamiliar, “H ɪɪ” is the notation for the spectrum of ionized hydrogen. Note to editors—photons, not baryons! It’s not always unambiguous.])

@Antaeus “Why on Earth does Mr. Pink even still bother to comment?”

Indeed, I think the question is more pertinent for you. You seem to keep coming back, but the closest thing you were able to articulate about the case report was a strawman about novel methodologies. Do you have any points to make about the case report yet?

It would be like making points against a report that claimed to prove a case of vaccine injury through palmistry, or phrenology, or oneiromancy. The burden of proof is on the person making such a claim to prove their methods are sound, not on everyone else to prove the opposite.

You claim that the methods are already proven to be sound science, but that claim rests on your credibility, and if you had any credibility before, it’s been torpedoed by your conduct here.

@Krebiozen

“As I have already explained, surrogate endpoints have to be used as it would be unethical to use invasive cancer as an endpoint, and in any case cervical cancer is rare.”

HRT was a population study and looked at breast cancer as an endpoint. Your point applies to pre-approval RCTs, not to post approval population study. As for rarity, that is exactly why you should be questioning full population based vaccination, especially since it doesn’t eliminate the need for screening that already occurs.

“That leaves us with a choice. We can run larger studies for longer and leave millions vulnerable to cancer,”

I love the circular reasoning. You can’t gather the proper evidence to see if it works, because if you assume it works, people will be at risk while you gather the evidence.

“Both the WHO and the FDA consider CIN-2 and CIN-3 to be valid surrogate endpoints to assess the effectiveness of HPV vaccines.”

You botched the argument based on the fact that most CIN-2 does not progress to CIN-3, so now you resort to an argument of authority.

“Public health authorities in Australia… have approved the vaccine with the great majority providing public funding…”

This is getting better, now you go for an argument of popularity — where is that flip guy when he would actually be right?

“Even so, all cervical cancer passes through stages 1 through 3, making it a reasonable assumption that if you reduce the incidence of stage 1 that will also reduce the incidence of cervical cancer, either directly through preventing initial infection, through herd immunity or both.”
Herd immunity for HPV is a pipe dream. Vaccination does not eliminate all infections so unless you identify the real risk factors for the small number of cases that progress, measuring the outcome based on a weak surrogate does not give you a whole lot of useful information about your endpoint.

“It is you who is being misleading here, since the paper you link to debates whether CIN-2 is a useful surrogate for cervical cancer in making treatment decisions, not whether it is a useful surrogate in looking at vaccine efficacy.”

The same logic applies. If you’re not treating it because the risk of progression is low, why would it be a valid surrogate for measuring future cancer diagnosis?

“Are you really suggesting that a disease that kills hundreds of thousands of women globally every year is not worth attempting to control? “

I think you meant 3,900 every year in US (compared to 32,000 gun deaths, or 44,000 deaths from medical error). Are you really suggesting we base a public health decision on data from the developing world?

“You do have a interesting habit of distorting information.”

No, that is your distortion. I’ll repeat the part you avoided quoting: You can’t have it both ways, if you want to exclude the results [people with prior HPV exposure], then you better make prior sexual activity a contraindication or do HPV testing prior to vaccination. Since the vaccine program does not exclude people with risk of prior exposure, you can’t exclude that extremely inconvenient data from the analysis or discussion. If 100% efficacy assuming no prior HPV exposure is the premise of your economic model, it’s a fail right out of the gate.

“There are several papers that discuss the pharmacoeconomics of the vaccine if anyone is interested for example here.”

[facepalm] You still haven’t learned to read your own references. That paper you linked uses the economic data from Kim et al which is the study I referenced in comment #565. It isn’t cost effective if you only vaccinate the wealthy population with access to health care. Please note your evidence does not support your prior assertion that half the efficacy is still cost effective. “Vaccination against HPV-16 and HPV-18 is expected to be economically attractive (i.e., <$50,000 per QALY) if high coverage can be achieved in the primary target group of 12-year-old girls and if vaccine-induced immunity is lifelong." Clearly your statements on cost (like many of your other statements so far) were not even close to being evidence based.

“Do you have a link? ATHENA was not designed to assess vaccine efficacy and I can only find references to a sub-group analysis looking at vaccinated and unvaccinated but not the data itself.”

It is not studying vaccine efficacy, but HPV strain prevalence. It certainly blows away any theories of 100% efficacy through prevention of HPV infection. Table 3. (Wright TC, Stoler MH, Behrens CM, et al. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol 2012;206:46.e1-11.)

“You ignore the VSD and rapid cycle analysis referred to on the CDC page I linked to that has actively surveilled over 600,000 vaccine recipients and the large body of evidence that supports the efficacy and safety of the vaccines.”

I didn’t ignore them at all. You didn’t provide any references documenting a safety analysis of Gardasil from these systems?

“That’s not true. You claimed that because the CDC got influenza mortality wrong we can’t believe what they have to say about HPV vaccine safety and efficacy. If that’s not stating that the CDC is an unqualified unreliable source I don’t know what is.”

No I did not. Read my comment again very carefully: “Their websites are not a reliable reference or evidence of anything in particular.” If they produce raw data or conclusions fully referenced by real published evidence, that is a acceptable since we can see the source of the data and judge the conclusions ourselves.

Sorry, reposting after blockquote fail:

“Even so, all cervical cancer passes through stages 1 through 3, making it a reasonable assumption that if you reduce the incidence of stage 1 that will also reduce the incidence of cervical cancer, either directly through preventing initial infection, through herd immunity or both.”

Herd immunity for HPV is a pipe dream. Vaccination does not eliminate all infections so unless you identify the real risk factors for the small number of cases that progress, measuring the outcome based on a weak surrogate does not give you a whole lot of useful information about your endpoint.

“It is you who is being misleading here, since the paper you link to debates whether CIN-2 is a useful surrogate for cervical cancer in making treatment decisions, not whether it is a useful surrogate in looking at vaccine efficacy.”

The same logic applies. If you’re not treating it because the risk of progression is low, why would it be a valid surrogate for measuring future cancer diagnosis?

“Are you really suggesting that a disease that kills hundreds of thousands of women globally every year is not worth attempting to control? “

I think you meant 3,900 every year in US (compared to 32,000 gun deaths, or 44,000 deaths from medical error). Are you really suggesting we base a public health decision on data from the developing world?

“You do have a interesting habit of distorting information.”

No, that is your distortion. I’ll repeat the part you avoided quoting: You can’t have it both ways, if you want to exclude the results [people with prior HPV exposure], then you better make prior sexual activity a contraindication or do HPV testing prior to vaccination. Since the vaccine program does not exclude people with risk of prior exposure, you can’t exclude that extremely inconvenient data from the analysis or discussion. If 100% efficacy assuming no prior HPV exposure is the premise of your economic model, it’s a fail right out of the gate.

“There are several papers that discuss the pharmacoeconomics of the vaccine if anyone is interested for example here.”

[facepalm] You still haven’t learned to read your own references. That paper you linked uses the economic data from Kim et al which is the study I referenced in comment #565. It isn’t cost effective if you only vaccinate the wealthy population with access to health care. Please note your evidence does not support your prior assertion that half the efficacy is still cost effective. “Vaccination against HPV-16 and HPV-18 is expected to be economically attractive (i.e., <$50,000 per QALY) if high coverage can be achieved in the primary target group of 12-year-old girls and if vaccine-induced immunity is lifelong." Clearly your statements on cost (like many of your other statements so far) were not even close to being evidence based.

“Do you have a link? ATHENA was not designed to assess vaccine efficacy and I can only find references to a sub-group analysis looking at vaccinated and unvaccinated but not the data itself.”

It is not studying vaccine efficacy, but HPV strain prevalence. It certainly blows away any theories of 100% efficacy through prevention of HPV infection. Table 3. (Wright TC, Stoler MH, Behrens CM, et al. The ATHENA human papillomavirus study: design, methods, and baseline results. Am J Obstet Gynecol 2012;206:46.e1-11.)

“You ignore the VSD and rapid cycle analysis referred to on the CDC page I linked to that has actively surveilled over 600,000 vaccine recipients and the large body of evidence that supports the efficacy and safety of the vaccines.”

I didn’t ignore them at all. You didn’t provide any references documenting a safety analysis of Gardasil from these systems?

“That’s not true. You claimed that because the CDC got influenza mortality wrong we can’t believe what they have to say about HPV vaccine safety and efficacy. If that’s not stating that the CDC is an unqualified unreliable source I don’t know what is.”

No I did not. Read my comment again very carefully: “Their websites are not a reliable reference or evidence of anything in particular.” If they produce raw data or conclusions fully referenced by real published evidence, that is a acceptable since we can see the source of the data and judge the conclusions ourselves.

@novalox “Hi. Try again with your petty insults, you really are entertaining… Besides, why should we listen to you…”

You need some serious training on how to write better insults. Orac has been regurgitating the same stuff for quite a while now so I would look elsewhere for good examples. Here is a lesson for you — and I know, this will be a shocker to someone who is craving for my attention — having you read my posts isn’t even in the top 1000 reasons I’m posting here. However, for some incomprehensible reason, you read them anyways. What does that make you? Ask Grant.

@narad “This may well be the most stupid thing you’ve put on offer yet”

Per my reference in the same post.
Mississippi — Median Annual Household income: US$36,674 — Age adjusted cervical cancer mortality rate: 3.6/100,000
Rhode Island — Median Annual Household income: US$55,980 — Age adjusted cervical cancer mortality rate: 1.8/100,000
Last time I checked 3.6 was double 1.8.
Quoting Ian Frazer: “Cervical Cancer is predominantly a disease of the developing world, with >250,000 deaths per annum. (Frazer I, “God’s Gift to Women: The Human Papillomavirus Vaccine, Immunity 25, 179-184)

@shay “No… cervical cancer does not recognize socioeconomic barriers.”

Read above. Access to healthcare is one of many reasons poor people suffer disproportionately from infectious diseases. If you think access to health care is the only one, you have some more research to do. Diet and smoking are among other factors implicated in cervical cancer and these also have correlations to socioeconomic conditions. If you had read the reference I provided, it points out that the people who will actually benefit from the vaccine are those that do not have access to healthcare. Unfortunately, these are the same people who do not get the vaccine. I will spell out the point since it apparently wasn’t obvious enough: It’s a waste of money to vaccinate the people with good access to health care but that’s exactly what you’re doing in the US. You are not actually vaccinating the people who the vaccine was designed to help.

@flip “So you’d agree with me that Lee’s paper is pretty useless until it’s replicated then? — Even assuming the contents of it are valid.

No I’d not agree with you. I think it is quite useful in pointing out an avenue for investigating some of the more serious reports of reactions. Replication is one of the steps. I’m sure Dr Lee would love to see his work replicated. That DNA fragment isn’t supposed to be in the vaccine and it certainly shouldn’t persist in the human body for any length of time. There is other evidence supporting it’s existence and unique properties as described in the new report I linked. Did you read it?

@bimler “basically the same article…”

Gosh, you really do have reading comprehension problems. You left half a dozen arguments hanging. Still having trouble with the last question?

@narad “Perhaps they (or somebody) should be notified that the listed affiliation is fraudulent. Note the received date. I suppose it’s time to check whether he self-plagerized.

It should be trivial for you to ask the “listed affiliation” to issue a public statement and post it back here. I look forward to reading more than empty allegations.

@Anteaus “It would be like making points against a report…”

I didn’t think you could answer the hard questions or even make a logical comment about the case report. In the words of the infamous Narad, “it must suck being a chickensh.t”

@mu “I love 10^36 fold amplification. That gives you what, a billion tons from a single 10k DNA fragment?”

You win the comment of the month award for that one while putting the wannabes to shame (Antaeus, Novolox, Bimler, Narad among others).

10^36 was a theoretical number if a nucleotide had been exponentially amplified 2^120 cycles non-stop in 4 same-nested PCRs. Similarly if you used the maximum 40 PCR rounds (from the Roche link) you would get a theoretical amplification of 1.09951 x 10^12 (2^40). This represents the maximum potential amplification in the system and reflects the fidelity of the low temperature PCR used in the study to prepare a template to perform an accurate DNA sequencing. If you are in the field, the PCR you use in your lab almost certainly can not accomplish that.

It is however correct to assume that if the E. coli in your colon is allowed to multiply 2^120 times exponentially non-stop, you would not live very long.

Here is a reference to others using the same technology for HPV genotyping: http://onlinelibrary.wiley.com/doi/10.1002/cam4.9/pdf

@AdamG “(Though, like Science Mom, I would have much preferred an RT-qPCR approach)…”
“Whoops! I should have clarified that I was referring to Real Time qPCR (for DNA), not Reverse Transcibed qPCR (for RNA) as Orac took it to mean. The nomenclature on these two is often interchanged and even in the literature it’s rather confusing…RT-qPCR refers to the DNA assay in my lab but I see this is not universal.”

AdamG, Grant and ScienceMom: I guess Merck didn’t get the memo from your labs regarding the superiority of that approach: “In this comparison study, neither assay was definitively considered a “gold standard” in HPV detection.” (Else EA et al, “Comparison of Real-Time Multiplex Human Papillomavirus (HPV) PCR Assays with INNO-LiPA HPV Genotyping Extra Assay”, JOURNAL OF CLINICAL MICROBIOLOGY, May 2011, p. 1907–1912)

@narad “Perhaps they (or somebody) should be notified that the listed affiliation is fraudulent. Note the received date. I suppose it’s time to check whether he self-plagerized.

It should be trivial for you to ask the “listed affiliation” to issue a public statement and post it back here. I look forward to reading more than empty allegations.

What’s the “empty allegation”? He doesn’t work for Milford now and didn’t in October 2012, when the paper was received. That’s why he sued them, remember?

@mr pink

Nah, the only reason I read your posts are for the lulz I get from your sheer ignorance and stupidity. Your infantile excuses, insults, and non-answers say a lot about you. Try again, never-can-be.

But I like you, since you seem soo easy to poke around and make mad.

And thank you for admitting that you do not have an coherent answer to the questions posted to you, and that I am intellectually superior to you, since you have proven that you can only spew lies again and again. I’ll take that as a compliment from a liar like you.

But please, keep entertaining us. I knew that you would come up with a piss-poor excuse for an insult, and I would like to see what pathetic excuse for an insult you can come up with next. I’ll see your answer in two days I suppose. More time to get some popcorn ready for you.

PS: Ripping your name from a character from Reservoir Dogs doesn’t improve your nonexistent argument at all

One might also note that Lee’s contact E-mail points to an AT&T LEC that doesn’t actually answer on port 25.

Or that the “Milford Molecular Laboratory” does not in fact seem to exist.

But let us return to Pink’s original suggestion. The phone number for the Milford Hospital PR department is (+1) 203-876-4060, manned 8a–4:30; EST. I’m probably not going to be able to hit this window, as my sleep schedule has lately been torpedoed, but I mention it in case anyone wants to register an inquiry about the continued use of the affiliation. They do not have an E-mail address that I’ve been able to locate.

The Great Google reports:

No results found for “Milford Molecular Laboratory” -lee.

If Lee has made up the b>name of the institution for which he works, then there is little reason to believe any of his assertions.

@Mr Pink

This is getting better, now you go for an argument of popularity — where is that flip guy when he would actually be right?

Probably off to the side laughing at your mix up over my gender. Boy, do I love using a gender-non-specific handle 🙂

Vaccination does not eliminate all infections so unless you identify the real risk factors for the small number of cases that progress, measuring the outcome based on a weak surrogate does not give you a whole lot of useful information about your endpoint.

And now we’re off to the races… a nirvana fallacy to begin with.

It isn’t cost effective if you only vaccinate the wealthy population with access to health care.

Mr Pink doesn’t live in Australia. For a certain age range, women were offered the vaccine for free via a government program. Fortunately in a country with universal health care, getting vaccinated is not so much a problem for poor folk. (I would have gotten it but had just missed the age cut-off. And yes, I need my government-subsidised health care otherwise I couldn’t afford to see a doctor, much less pay for anything else)

Making long term public health decisions based on only on weak evidence is foolish and generally leads to wasted money

Like changing a policy on giving the HPV vaccine based on one non-replicated paper by one scientist for instance?

Flip, you shouldn’t worry about the typos, it’s the strawman you should be focused on. Who recommended changing any policies based on the case report? My objection to the policy of mass vaccination is based on a glaring lack of evidence of efficacy in real life situations, not the case report. Even you should be able to keep up with that.

So you’d agree with me that Lee’s paper is pretty useless until it’s replicated then? – Even assuming the contents of it are valid.

No I’d not agree with you. I think it is quite useful in pointing out an avenue for investigating some of the more serious reports of reactions. Replication is one of the steps. I’m sure Dr Lee would love to see his work replicated. That DNA fragment isn’t supposed to be in the vaccine and it certainly shouldn’t persist in the human body for any length of time. There is other evidence supporting it’s existence and unique properties as described in the new report I linked. Did you read it?

Ding ding ding, we have a winner!

Thank you for playing Mr Pink. Here we quite clearly see that Mr Pink is not interested in confirming any analysis that agrees with his point of view, because one paper is enough; but if it disagrees with his point of view, be sure to call out for more research and argue that there is “weak evidence”. But he knows it’s silly, so he equivocates with “No I’d not agree with you” but yes “replication is one of the steps”.

F*k but you walked into that one. Didn’t you bother to pay attention to my questions? Or was I too subtle for you to see the punch line coming?

@Mr Pink:

Per my reference in the same post.
Mississippi — Median Annual Household income: US$36,674 — Age adjusted cervical cancer mortality rate: 3.6/100,000
Rhode Island — Median Annual Household income: US$55,980 — Age adjusted cervical cancer mortality rate: 1.8/100,000
Last time I checked 3.6 was double 1.8.

Mr Pink misses the difference between mortality and morbidity.

As a thought experiment, suppose a hundred women in Rhode Island develop a certain form of cancer, all endure expensive and life-altering treatment (such as surgery, chemo, or radiation), and half of them survive.  Meanwhile in Mississippi a hundred women develop the same form of cancer and all die without treatment. The mortality rate in Rhode Island is half that of Mississippi, but does that really mean that the problem in Rhode Island is half that in Mississippi?

Antivaxxers make the same mistake. If, thanks to modern medicine, antibiotics, ventilators, and so on, mortality from measles is much lower than it was in the Thirties, that means we don’t need to vaccinate against measles, right?  Only if you don’t mind children ending up on ventilators or suffering permanent brain damage.

Mr. Pink,

HRT was a population study and looked at breast cancer as an endpoint. Your point applies to pre-approval RCTs, not to post approval population study.

Breast cancer is more than 10 times more common than cervical cancer. It is you who are suggesting that such RCTs should have been done before vaccine approval. With cervical cancer incidence at around 7 cases per 100,000 women per year in the US you would have to study a very large number of women for at least a year if you wanted to use invasive cancer as an endpoint and have enough statistical power. That’s why a surrogate endpoint was used instead.

As for rarity, that is exactly why you should be questioning full population based vaccination, especially since it doesn’t eliminate the need for screening that already occurs.

Prevention and early detection are two separate things. Using both should enable us to greatly reduce morbidity and mortality, and once incidence of cervical cancer is reduced enough no doubt screening protocols will be changed. If you really think that a condition that causes suffering and death in thousands of people every year is too rare for it to be worthwhile adopting measures to prevent it, then I can only disagree with you.

I love the circular reasoning. You can’t gather the proper evidence to see if it works, because if you assume it works, people will be at risk while you gather the evidence.

If you accept surrogate markers as viable, and you have presented no good reasons not to, then there is no circular reasoning. That’s why the Data and Safety Monitoring Board terminated the FUTURE II trials in 2006, because it would have been unethical to deny the placebo group the vaccine because, I wearily repeat, the vaccine clearly reduces CIN and it is reasonable to assume that it will also prevent invasive cancer. You disagree with this assumption, I get that, but I don’t really understand why.

You botched the argument based on the fact that most CIN-2 does not progress to CIN-3, so now you resort to an argument of authority.[…] This is getting better, now you go for an argument of popularity — where is that flip guy when he would actually be right?

Now you are claiming that an international scientific consensus that CIN is an adequate surrogate for cervical cancer in assessing vaccine efficacy, based on a large body of evidence is an argumentum ad populum? What part of “large body of evidence” is it that you don’t understand?

Herd immunity for HPV is a pipe dream.

Why? We have an effective quadrivalent vaccine that is safe and effective by all sensible measures. Why is it a pipe dream to suggest that in the future we may be able to produce effective vaccines against all other high risk strains and eliminate HPV the same way smallpox has been eliminated?

Vaccination does not eliminate all infections so unless you identify the real risk factors for the small number of cases that progress, measuring the outcome based on a weak surrogate does not give you a whole lot of useful information about your endpoint.

Unfortunately it is identifying the risk factors for progression that appears to be a pipe dream. If we knew in advance which cases of HPV will progress to cervical cancer, we wouldn’t need to vaccinate against it or even treat it, except in those cases, would we? As I mentioned before, you seem to subscribe to the Nirvana fallacy, that if vaccination isn’t 100% safe and effective, or if vaccine uptake is not 100% it isn’t worth doing. I think that’s foolish.

If you’re not treating it because the risk of progression is low, why would it be a valid surrogate for measuring future cancer diagnosis?

A low risk in a very large number of people results in a large number of people at risk. If vaccination prevents HPV, the risk of progression becomes essentially zero. Or to put it another way the risk/cost of treatment greatly exceeds any risks/costs of vaccination. CIN is used as a surrogate for an entirely different purpose in each case.

I think you meant 3,900 every year in US (compared to 32,000 gun deaths, or 44,000 deaths from medical error). Are you really suggesting we base a public health decision on data from the developing world?

Use whatever figures you prefer, though gun deaths and medical errors are an irrelevant tu quoque here. HPV in general and cervical cancer in particular has a significant morbidity and mortality in both the developing and the developed world; that’s the point I was making, and I think that’s undeniable. Also, you may not be concerned about the health of those in the developing world, but I am.

You can’t have it both ways, if you want to exclude the results [people with prior HPV exposure], then you better make prior sexual activity a contraindication or do HPV testing prior to vaccination. Since the vaccine program does not exclude people with risk of prior exposure, you can’t exclude that extremely inconvenient data from the analysis or discussion. If 100% efficacy assuming no prior HPV exposure is the premise of your economic model, it’s a fail right out of the gate.

I don’t want to exclude any results. The results you have referred to that suggested that HPV vaccinations actually increase the risk of high risk strain infection in those previously infected have not been replicated in further studies. It seems to me it is you who wants it both ways. “Gardasil is recommended for 11- and 12 year-old girls, and also females 13 through 26-year-old who were not previously vaccinated”, remember? If this recommendation is followed then most girls will be vaccinated before they are exposed. I don’t have an economic model, I am suggesting that HPV infection leads to economic costs and also causes unquantifiable human suffering that I believe is worth tackling through vaccination. There is no citation I can provide to quantitate the cost of that suffering. As I wrote before, there is an argument to be had about the socioeconomic benefits of HPV vaccination, and I clearly disagree with you over this, as do the majority of experts internationally.

[facepalm] You still haven’t learned to read your own references. That paper you linked uses the economic data from Kim et al which is the study I referenced in comment #565. It isn’t cost effective if you only vaccinate the wealthy population with access to health care. Please note your evidence does not support your prior assertion that half the efficacy is still cost effective. “Vaccination against HPV-16 and HPV-18 is expected to be economically attractive (i.e., <$50,000 per QALY) if high coverage can be achieved in the primary target group of 12-year-old girls and if vaccine-induced immunity is lifelong." Clearly your statements on cost (like many of your other statements so far) were not even close to being evidence based.

I didn’t say that “half the efficacy is still cost effective”, I talked about “worth” in which I would include non-economic factors. Economic attractiveness is a subjective measure, and QALYs are a controversial way of quantifying human well-being. The statement that “Vaccination against HPV-16 and HPV-18 is expected to be economically attractive (i.e., <$50,000 per QALY) if high coverage can be achieved in the primary target group of 12-year-old girls and if vaccine-induced immunity is lifelong." supports my arguments, does it not? If there was less misinformation about vaccine safety being disseminated perhaps it would be easier to achieve greater vaccine coverage and it would be even more economically viable. I don't think you are helping in this regard.

It is not studying vaccine efficacy, but HPV strain prevalence. It certainly blows away any theories of 100% efficacy through prevention of HPV infection.

That vaccination data is for just over 1000 women aged 21-29 who could not possibly have been 12 years old when vaccinated when you consider when the vaccine was licensed. I don’t expect 100% efficacy in the real world, but if vaccine uptake is kept high enough for long enough it will have a dramatic effect on the prevalence of HPV-16 and 18 infection and associated cancers. I expect future vaccine development to address other strains.

Regarding VSD and rapid cycle analysis:

I didn’t ignore them at all. You didn’t provide any references documenting a safety analysis of Gardasil from these systems?

Are you really incapable of clicking on the links in the list of ‘Related Scientific Articles’ at the bottom of the CDC webpage that I linked to? Here they are:
Gee J, Naleway A, Shui I, Baggs J, Yinc R, Lic R, Kulldorff, M, Lewis E, Fireman B, Daley, MF, Klein NP, Weintraub ES. Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink, Vaccine 2011 Oct 26;Vol 29, Issue 46: 8279-8284 (PMID: 21907257).
Slade BA, Leidel L, Vellozzi C, Woo EJ, Hua J, Sutherland A, Izurieta HS, Ball R, Miller N, Braun MM, Markowitz LE, Iskander J. Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. JAMA 2009 Aug 10;302(7):750-7 (PMID: 19690307)
Centers for Disease Control and Prevention (CDC) and ACIP. Quadrivalent human papillomavirus vaccine. [PDF – 444 KB] MMWR 2007 Mar 23; 56(RR-2).
MMWR – FDA Licensure of Quadrivalent Human Papillomavirus Vaccine (HPV4, Gardasil) for Use in Males and Guidance from ACIP.

“That’s not true. You claimed that because the CDC got influenza mortality wrong we can’t believe what they have to say about HPV vaccine safety and efficacy. If that’s not stating that the CDC is an unqualified unreliable source I don’t know what is.”

No I did not. Read my comment again very carefully: “Their websites are not a reliable reference or evidence of anything in particular.” If they produce raw data or conclusions fully referenced by real published evidence, that is a acceptable since we can see the source of the data and judge the conclusions ourselves.

Everything on the CDC website is supported by real published evidence. There are several links there to further information and research that supports what I have been arguing.

Everything on the CDC website is supported by real published evidence.

That is perhaps a somewhat over-encompassing statement. Lest anyone misunderstand me, I was referring to the CDC’s position on HPV vaccine safety and the utility of surrogate endpoints in assessing efficacy.

Why is it a pipe dream to suggest that in the future we may be able to produce effective vaccines against all other high risk strains and eliminate HPV the same way smallpox has been eliminated?

That’s a lofty goal. You have a reservoir and latency to contend with. Quarantine is certainly out.

If cost effectiveness is all we’re concerned about, why aren’t we practicing horse track medicine?

Regards “Or that the “Milford Molecular Laboratory” does not in fact seem to exist.” and the like.

Perhaps there is a company register that can supply details?

I suspect the best that can be said is that this laboratory has no web presence, at least outside of this SaneVax order form. (PDF file).

Perhaps the only work MML gets is via these SaneVax orders so Lee/MML and/or SaneVax feels there is no need for a web presence as such?

A list of Lee’s papers shows the addresses on them have changed from “Department of Pathology, Milford Hospital” for his 2008-2010 papers (in one case giving 300 Seaside Avenue as the street address, which is the hospital address) to “Milford Hospital and Milford Molecular Laboratory, 2044 Bridgeport Avenue” for his 2012 papers, which is across the road from the hospital.

Searching for “2044 Bridgeport Avenue, CT” brings up Quest Diagnostics and a number of medics and medical services occupying that address. StreetView shows this as grey brick building which I guess has number of suites occupied by various independent workers in addition to Quest Diagnostics.

Lee might have listed both Milford Hospital and his new location as addresses if he felt the work was done in both places.

If Lee’s was done without the hospital’s approval, or in a way that the hospital did not approve, then perhaps the hospital would be less than happy with their name being on the papers. You’d have to ask them, really.

(Certainly I’d like to Lee to have said to the coroner’s inquiry that the work was commissioned by SaneVax: you’d wish autopsy work to be done via players with no vested interests, but SaneVax has a vested interest.)

My previous comment (#602) should have been addressed to Narad.

“If Lee’s was” should read “If Lee’s work was”.

Narad,
On the possibility of eradicating HPV:

That’s a lofty goal. You have a reservoir and latency to contend with. Quarantine is certainly out.

A lofty goal perhaps, but I don’t think it’s an impossible one. There’s no non-human reservoir as far as I am aware; the current human one will die off given enough time and people tend to have sex with those of a similar age, making vertical (in terms of age) transmission less common. It would require maintaining high rates of vaccination uptake for a long time, better means of detection and probably effective treatments in addition to vaccination.

I realize I am being (possibly unrealistically) optimistic about the future of medicine. I don’t think antivaxxers realize the possibilities that vaccines offer, such as eradication of viruses that would ultimately eliminate the need for vaccines against them, so I like to throw the idea into the mix from time to time.

Perhaps there is a company register that can supply details?

Indeed. Plug in business ID 0270302. The listed mailing address on the detail record, 300 Seaside Avenue, is that for the hospital, although the summary record has 2068 Bridgeport. This latter address finally gets one here.

@Anteaus “It would be like making points against a report…”

I didn’t think you could answer the hard questions or even make a logical comment about the case report. In the words of the infamous Narad, “it must suck being a chickensh.t”

No, “hard questions” is what your questions would be if the burden of proof wasn’t still on Lee and his supporters to show the soundness of their work. Do you understand this?

Show us you understand this. “How can you deny the evidence obtained through oneiromancy that says this young woman was killed by a vaccine?” – in a world, such as ours, where oneiromancy has not been shown to produce reliable evidence, do you assert that a question such as this, founded on “evidence” produced through such unsupported methods, is still a “hard question”?

Since you’re awfully fond of changing the subject and asking new questions, rather than answering the questions asked of you, we’re going to make this an ultimatum question. If you make three comments, on this or any other RI post, without answering the question, it will be taken as an admission that questions relying on unproven methodologies aren’t “hard questions” at all (no matter how convinced devotees of those methodologies are that they are sound and will someday be proven so.)

Lee might have listed both Milford Hospital and his new location as addresses if he felt the work was done in both places.

It is of course normal to list the primary affiliation as that where the work was done, but it’s also normal to indicate (e.g., in a footnote) what the current affiliation is, even if it’s just a home address. This whole presentation just smells fishy, and it goes without saying that SCIRP doesn’t have a staff that minds such details.

@narad “One might also note that Lee’s contact E-mail points to an AT&T LEC that doesn’t actually answer on port 25.”

Many ISP’s have been blocking that port for years. The depths of igorance exposed by that inane observation is telling. Stick to your day job.

@mephistopheles O’Brien “If cost effectiveness is all we’re concerned about, why aren’t we practicing horse track medicine?”

We were talking about real life and public health. Since there isn’t enough money to go around, you fund the initiatives that give you the best return on money spent, which of course maximizes the reduction of pain, suffering and death. If you are aware of a better criteria, let’s hear it.

@lw “Mr Pink misses the difference between mortality and morbidity. As a thought experiment, suppose a hundred women in Rhode Island develop a certain form of cancer, all endure expensive and life-altering treatment (such as surgery, chemo, or radiation), and half of them survive.”

Thought Experiment Fail: Access to health care reduces cervical cancer mortality not primarily due to the treatment of the disease, but because of access to screening (regular pap tests) helps avoid most of those expensive life altering treatments. And BTW, the cost analysis in the study I referenced uses QALY which factors in all those things you discussed. Vaccine bullies make the same mistake all the time, drawing false conclusions after making grossly invalid assumptions usually based on ignorance.

@Antaeus “Show us you understand this. “How can you deny the evidence obtained through oneiromancy that says this young woman was killed by a vaccine?””

Antaeus, you’re really off on some tagent comparing devining through dreams with nested PCR in a lab. I’m worried about you, get some help, please.

@Grant
You’re back! You were secretly lurking here all along! Like a worm on a rainy day, the minute Narad starts a new track away from the science, you crawl right out the ground to try to swim in the puddle. All those non-science arguments must really interest you. BTW, the judge down under had no illusions who brought in the “foreign scientists” — the ME sure looked to be a bit lacking in the science department — because he complimented the family in going to get other opinions. Did you even know that?

@flip

Mr Pink doesn’t live in Australia

Wow, you are perceptive. You’re also right that the US vaccine delivery problems won’t necessarily apply to other countries. Do you want a high five for that perceptive observation too? The only thing Australian public health has to do is keep the faith and hope really hard that the vaccine actually works based on the laughable assumption of 100% efficacy.

And now we’re off to the races… a nirvana fallacy to begin with.

It wasn’t me who proposed herd immunity or eradication of HPV. That’s the nirvana fallacy.

Strawman #2:

“Here we quite clearly see that Mr Pink is not interested in confirming any analysis that agrees with his point of view, because one paper is enough;”

I said “I think it is quite useful in pointing out an avenue for investigating some of the more serious reports of reactions.” That doesn’t even come close to meaning one paper is enough. Do they teach different english down under?

Strawman #3:

“But he knows it’s silly, so he equivocates with “No I’d not agree with you” but yes “replication is one of the steps”.”

You said “So you’d agree with me that Lee’s paper is pretty useless until it’s replicated then?”
There is one key assertion in that statement –> Dr Lee’s paper is pretty useless.
My response “I think it is quite useful in pointing out an avenue for investigating some of the more serious reports of reactions.” That’s a clear disagreement –> I stated the report was quite useful.
That’s not equivocating and it’s not ambiguous at all. Pointing out that replication is a natural next step does not weaken or change my position that you were completely wrong in your assertion.
Claiming that’s equivocating is some dumb.

“F*k but you walked into that one. Didn’t you bother to pay attention to my questions? Or was I too subtle for you to see the punch line coming?”

High fives to flip for beating the tar out of that strawman argument! There is a big crater in the ground and the straw stuffing flew 10 feet high in all directions. Hoo-rah.

Now that you’ve been supremely victorious and killed a whole series of strawmen (or were they strawwomen), do you want to get back to real life and bring a single substantial critique about the case report to the table?

@Krebiozen

“It is you who are suggesting that such RCTs should have been done before vaccine approval.”

I suggested no such thing. Do you want to beat the tar out of the strawwomen too, because you’re just wasting time making up my arguments and then beating them down in a cloud of straw and dust. You and flip should take reading comprehension classes together.

“With cervical cancer incidence at around 7 cases per 100,000 women per year in the US you would have to study a very large number of women for at least a year if you wanted to use invasive cancer as an endpoint and have enough statistical power.”

Whine, whine, whine. HRT studies had 1 million women in the UK and the US based WHI study had 160,000 women. That should be more than enough to get good results on cervical cancer vaccination. Remember, the evidence part from evidence based medicine?

“Prevention and early detection are two separate things. Using both should enable us to greatly reduce morbidity and mortality, and once incidence of cervical cancer is reduced enough no doubt screening protocols will be changed.”

Screening is required because the vaccine only targets specific strains and other strains can cause cervical cancer. Screening already drastically reduces both the mortality and morbidity from cervical cancer. You saw the quote from Ian Frazer: the vaccine’s most obvious use is the developing world, not where people have good access to healthcare.

If you really think that a condition that causes suffering and death in thousands of people every year is too rare for it to be worthwhile adopting measures to prevent it, then I can only disagree with you.

Really, the pain and suffering gambit, from the same guy who stormed out here lecturing about public health needing to take gambles? What would happen if you applied that money to reduce medical error which causes way more suffering and death than cervical cancer and is one of the leading causes of death in the US? Which approach reduces more suffering and death? What causes more pain and suffering for others: an unnecessary death due to a mistake by the medical community, or death by disease?

If you accept surrogate markers as viable, and you have presented no good reasons not to, then there is no circular reasoning.

Aye, but that’s the point isn’t it? This core argument is about the validity of the choice of surrogate outcome. I’ve produced good evidence to support that CIN-2 is not a very accurate surrogate at all and certainly is not universally accepted as such. You’re the one bringing up the ethical argument to counter it. You can’t counter a lack of efficacy argument with ethics because that creates the circular reasoning.

If we knew in advance which cases of HPV will progress to cervical cancer, we wouldn’t need to vaccinate against it or even treat it, except in those cases, would we?

I am saying exactly that, we don’t need to vaccinate against it where you have good access to healthcare. There are many well known risk factors associated with cervical cancer. The real problem is none of them involve pharmaceutical profit. That’s the case with the most expensive chronic diseases as well in case you hadn’t figured that out yet.

Use whatever figures you prefer, though gun deaths and medical errors are an irrelevant tu quoque here… Also, you may not be concerned about the health of those in the developing world, but I am.

You are the one who brought public health into the argument at the beginning. High causes of death always involve public health (including guns, google it) so those stats are entirely relevant because the money you’re wasting on the vaccine could save a lot more people if spent elsewhere. There was no fallacy there.

“Gardasil is recommended for 11- and 12 year-old girls, and also females 13 through 26-year-old who were not previously vaccinated”, remember? If this recommendation is followed then most girls will be vaccinated before they are exposed.

In the poor states, you aren’t anywhere near 100% coverage. In the age range of 13-26 what percentage of girls and women have not been exposed to HPV?

The statement that “Vaccination against HPV-16 and HPV-18 is expected to be economically attractive (i.e., <$50,000 per QALY) if high coverage can be achieved in the primary target group of 12-year-old girls and if vaccine-induced immunity is lifelong." supports my arguments, does it not? If there was less misinformation about vaccine safety being disseminated perhaps it would be easier to achieve greater vaccine coverage and it would be even more economically viable.

You didn’t read my reference from Bach did you? He uses the Kim et al study and points out that unless you vaccinate the populations at high risk in the US (i.e. the poor states without access to health care) the initiative is no longer cost effective (I pointed out Narad’s foot-in-mouth by showing the large differences in cervical cancer mortality rates between wealthy and poor states). Unfortunately, you are not vaccinating the poor states properly, so the initiative is no longer cost effective. And since you clearly have problems with comphrehending this point I will spell it out for you: low rates of vaccination in poor populations in the US is due to lack of access to health care, NOT safety concerns so your false argument about misinformation is rhetorical musing, nothing more.

I didn’t say that “half the efficacy is still cost effective”, I talked about “worth” in which I would include non-economic factors. Economic attractiveness is a subjective measure, and QALYs are a controversial way of quantifying human well-being.

Slow down there fast one. QALY is the way public health quantifies the “worth” of a medical intervention. You invoked both public health and efficacy proving worth. You referenced the study that does the calculation using QALY!. You’re trying to move the goalpost AGAIN, and now I suppose you would choose to retract that reference now right?

Are you really incapable of clicking on the links in the list of ‘Related Scientific Articles’ at the bottom of the CDC webpage that I linked to?

I missed the Gee study on VSD, the other one you linked was VAERS which I already addressed. Did you read the study? (I sense a pattern here) They only looked for pre-determined outcomes (pre-specified ICD-9 codes) which is very different from a thorough safety analysis. This is what the CDC says on their site: “This is because pre-licensure trials are often too small to detect rare events and special populations may not be adequately represented.” So how does studying pre-determined outcomes help “detect rare adverse events that were not identified during pre-licensure clinical trials?”
One single study which was limited to pre-determined adverse events + one study on VAERS which gets a small fraction of unreliable reports “plenty of post-marketing evidence to suggest HPV vaccines are remarkably safe…”
Cognitive dissonance?

BTW, Did you ever figure out why that systematic review you posted doesn’t count as post-marketing evidence?

@Krebiozen

Why is it a pipe dream to suggest that in the future we may be able to produce effective vaccines against all other high risk strains and eliminate HPV the same way smallpox has been eliminated?

OMG, you have really exposed your ignorance on vaccination with that one. Do you have any idea how smallpox was actually eradicated? Are you even aware that herd immunity for pertussis (one of the older vaccine preventable diseases) is a pipe dream? It is true irony that the same poster who erroneously quipped that I invoked the nirvana fallacy, turns around and suggests that HPV could be eradicated through vaccination. It is such a ridiculous suggestion that Narad (the self appointed referee) had to politely come by and tell you to back away from that one because you’re making his side look really bad.

“I don’t have an economic model, I am suggesting that HPV infection leads to economic costs and also causes unquantifiable human suffering that I believe is worth tackling through vaccination.”

I see you’ve really shifted the goalpost now. Let’s take a trip back to Post #547:
“Even if the effectiveness of these vaccines was half that found in clinical trials, they would still be well worth using as a means of reducing morbidity and mortality.” –> Apparently now, you’re claiming that this was a statement of opinion not based on any evidence at all.

Your arguments are all over the place. You invoked public health by storming into this argument with definitive statements of confidence in the vaccine program lecturing about taking gambles in public health: “Public health decisions like this are always a gamble to some extent. … We never have the luxury of certainty in the arena of public health.” When you invoke public health the term “worth” is well defined. I suppose by your new argument (i.e. shifted goalpost), public health should be gambling — in an era with of scarce funding — without evidence, or even an economic model.

Ignoring your over the top comments about safety, you assert that the vaccine is successful before a single shred of evidence has even been collected regarding the desired endpoint of cervical cancer.
“We have every reason to believe the vaccine will reduce the incidence of cervical cancer.”
“The evidence also shows beyond any reasonable doubt that the presence of precancerous cervical lesions is predictive of cervical cancer.”

You use inaccurate and completely definitive terms to characterize the state of evidence.
It has been proven to reduce the risk of cervical changes that are known to be associated with cervical cancer in the short term

When shown that your surrogate outcomes are far from a sure thing, you back off the unscientific language and you invoke:
False argument of authority –> The WHO and FDA says so, therefore it must be the right decision.
False argument of popularity –> Everyone else is doing it
Circular reasoning –> It must be effective because it’s unethical to study the endpoint

None of these arguments are evidence based and they don’t support your notion that CIN-2 is a credible surrogate for cervical cancer. The first preliminary real life evidence of HPV prevalence in the population blows the confident predictions right out of the water.

Now you’re furiously backpedalling and invoking emotional arguments like “pain and suffering” and caring for the developing world. I’ll take that as a concession because the program we’ve been discussing here isn’t focused on the developing world and public health decisions shouldn’t be based on emotional arguments. “Pain and suffering” will be reduced if public health spends it’s money in the most effective way, but that requires cost models and quantitative measures.

I applaud your intentions on reducing morbidity and mortality, and I sincerely believe you have the right motives. The problem IMO, is that your faith (“We have every reason to believe the vaccine will reduce the incidence of cervical cancer.”) is misplaced in a program that is based on seriously flawed assumptions for the developed world. Because of that, it has a high probability of being an enormous waste of money. Money that would be far better spent elsewhere reducing morbidity and mortality in your developed country.

Many ISP’s have been blocking that port for years. The depths of igorance exposed by that inane observation is telling. Stick to your day job.

Perhaps you don’t grasp the point. Perhaps you would like to try dropping him a line using a normal sendmail client.

(For those unfamiliar with Pink’s claim of “depths of ignorance,” many ISPs block outbound port 25 to prevent their clueless customers from functioning as botnet nodes.)

It is such a ridiculous suggestion that Narad (the self appointed referee) had to politely come by and tell you to back away from that one because you’re making his side look really bad.

I didn’t tell K. to “back away from” anything, I said that eradication is a lofty goal, the practicalities of which he readily acknowledged.

CORRECTION in Post 610:
The parser ate my do not equal sign. It should read:

@krebiozen:
One single study which was limited to pre-determined adverse events
+ one study on VAERS which gets a small fraction of unreliable reports
DOES NOT EQUAL
“plenty of post-marketing evidence to suggest HPV vaccines are remarkably safe…”

@Narad “Perhaps you don’t grasp the point. Perhaps you would like to try dropping him a line using a normal sendmail client.”

Now that really is some dumb. Serious mail providers typically only accept traffic on port 25 from pre-approved MTAs, not personal mail servers. You should be originating your mail connecting through an MSA on port 587, unless you’re trying to hide something or spam email that is.

@Narad “I didn’t tell K. to “back away from” anything, I said that eradication is a lofty goal, the practicalities of which he readily acknowledged.

Lofty goal? I said it was a polite warning. He didn’t acknowledge the key missing ingredient of quarantine at all — which indicates he doesn’t understand how smallpox was really eradicated.

Narad,

re, #605: MML is “a subsidiary of Milford Hospital”, then – so Lee has the work as being done entirely within Milford Hospital. OK, good that’s sorted. Not what I was expecting though given, I thought, Milford had disemployed him at an earlier date, but it makes the outcome of the legals more interesting I suppose (?)

re, #607: “but it’s also normal to indicate (e.g., in a footnote) what the current affiliation is” – Originally wrote as much in my comment, but canned it.

A key difference between smallpox and HPV is that smallpox spreads through the air and HPV does not. Hence, one person with smallpox could infect an entire jumbo jet full of passengers during one trans-Atlantic flight, whereas it would be relatively uncommon for a person to infect an equivalent number of other people with HPV even over the course of a lifetime. Hence, the need for quarantine with smallpox does not necessarily imply an equivalent need for quarantine with HPV.

Now that really is some dumb. Serious mail providers typically only accept traffic on port 25 from pre-approved MTAs, not personal mail servers. You should be originating your mail connecting through an MSA on port 587

This betrays extreme stupidity. Do you even actually know what an MTA is? Don’t try to teach your grandmother how to suck eggs.

Hence, the need for quarantine with smallpox does not necessarily imply an equivalent need for quarantine with HPV.

True enough, but commensurately, tactics such as ring vaccination are out. This will be a long-term endeavor, as K. has noted. You just don’t know where it “is.”

Lofty goal? I said it was a polite warning.

You said no such thing. Your words were that I “had to politely come by and tell [Krebiozen] to back away from that one because you’re making his side look really bad.”

I issued no “warning,” and I did not tell K. to “back away from” anything.

Serious mail providers typically only accept traffic….

/Users/narad> telnet gmail.com 25
Trying 74.125.142.83…
^C
/Users/narad> telnet gmail.com 80
Trying 74.125.142.83…
Connected to gmail.com.
Escape character is ‘^]’.
^C
/Users/narad> telnet gmail.com 587
Trying 74.125.142.83…
^C

Get it yet?

Allow me to clarify further.

/Users/narad> telnet smtp.gmail.com 25
Trying 74.125.133.108…
Connected to gmail-smtp-msa.l.google.com.
Escape character is ‘^]’.
220 mx.google.com ESMTP dy5sm4338538igc.1 – gsmtp
^]
telnet> close
Connection closed.

“True enough, but commensurately, tactics such as ring vaccination are out.”

Oh, granted. Mr Pink was sneering at Krebiozen for not mentioning quarantine in connection with potential eradication of HPV. I was pointing out that quarantine isn’t as relevant to HPV as it was to smallpox so there wasn’t really any reason for Krebiozen to bring it up.

Also, Mr Pink doesn’t grasp the meaning of “thought experiment.”

To close the position,

/Users/narad> dig -t mx snet.net

; <> DiG 9.3.6-APPLE-P2 <> -t mx snet.net
;; global options: printcmd
;; Got answer:
;; ->>HEADER< telnet nb-mx-vip1.prodigy.net 25
Trying 207.115.36.20…
Connected to nb-mx-vip1.prodigy.net.
Escape character is ‘^]’.
220 nlpi167.prodigy.net ESMTP Sendmail 8.14.4 IN/8.14.4; Sat, 2 Mar 2013 16:28:34 -0600
^]
telnet> close
Connection closed.

See? I was wrong, but in kneejerk response, you were even wronger.

Hmph, that got oddly truncated midway. Anyway, the ‘dig’ yields the prodigy.net MXs that happily answer on port 25; it’s easy enough to test for oneself.

. I will spell out the point since it apparently wasn’t obvious enough: It’s a waste of money to vaccinate the people with good access to health care but that’s exactly what you’re doing in the US. You are not actually vaccinating the people who the vaccine was designed to help.

I don’t know where to start…Adam, I feel your pain.

It’s a waste of money to vaccinate people with access to health care? Holy steamin’ pile o’ stupid. Yes, my friends, let yourselves and your kids risk genital warts, RRP, and vulvar, vaginal, anal or oropharyngeal cancer because treating these is so much cheaper than a shot.

We’re not actually vaccinating the people that the vaccine was designed to help? Per the CDC, HPV is now so common that all sexually active adults are at risk, not just the po’ folks.

FYI, the vaccine is now offered by many health departments as part of the vaccination program for children from low-income families.

There are some interesting snippets in that webcast. For example a 50% reduction in genital warts has already been seen in younger (vaccinated) women in Melbourne, but not in older (unvaccinated) women, so it must be due to the vaccine. A similar reduction has been seen in genital warts in young heterosexual men (unvaccinated), presumably due to the herd immunity that Mr. Pink claims is a pipe dream. Also, you need to vaccinate 31 girls to prevent a case of CIN-2/3, 639 girls to save 1 life, and 14 girls to save 1 year of life, figures that are much lower than for other vaccines, which rather elegantly expresses what I have been trying to explain, perhaps somewhat inarticulately, about the value of the vaccine. Finally, polyvalent vaccines were in Phase 3 clinical trials in 2009 so presumably will be within a few years.

Let it be noted that Mr. Pink definitely saw the ultimatum question, even quoted from it, but posted three comments without even attempting to answer. As warned, Pink’s attempts to avoid the question will be taken as an admission that Lee’s supposed “evidence” against Gardasil is utterly meaningless until and unless Lee’s methodologies become accepted, verified science.

Of course, Pink will claim that Lee’s methodologies already are accepted, verified science. This is false.

This paper reports the experience in developing a method for the detection and validation of minute quantities of HPV-16 L1 gene DNA in the postmortem blood and spleen obtained at autopsy.

That’s from Lee’s own paper; Lee himself is admitting that his methodology is novel. Any fool who claims that Lee’s results must be as solid as those obtained through standard techniques of nested PCR because Lee’s newly developed method also employs nested PCR, doesn’t understand Lee’s own paper and has no credibility when assuring us how very convincing it is.

LW,

I was pointing out that quarantine isn’t as relevant to HPV as it was to smallpox so there wasn’t really any reason for Krebiozen to bring it up.

I would suggest that it is HPV antibody testing and the use of safe sex or abstention in those who test positive that will be analogous to the use quarantine in the eradication of smallpox. It wasn’t that long ago I was trying in vain to explain to Th1Th2 that it was the use of surveillance, isolation and vaccination together that eliminated smallpox, with her insisting that the vaccination part was unnecessary.

I think you need to get the prevalence down via vaccination before antibody testing is practical. If something like half the adult population is exposed, you can’t very well test everyone and urge safe sex or abstention just on the exposed. Anyway, everyone should be encouraged to act in ways that reduce the spread of HPV, as well as other such diseases.

LW,

I think you need to get the prevalence down via vaccination before antibody testing is practical. If something like half the adult population is exposed, you can’t very well test everyone and urge safe sex or abstention just on the exposed.

I agree. Eradication in this way this would require a long-term strategy over the next 50 years or more.

Anyway, everyone should be encouraged to act in ways that reduce the spread of HPV, as well as other such diseases.

True, but that’s not entirely practical if you want to reproduce.

BTW I would add an effective treatment for HPV infection to my expectations (or perhaps utopian wish-list) for future medical developments.

@Krebiozen “There are some interesting snippets in that webcast. For example a 50% reduction in genital warts has already been seen in younger (vaccinated) women in Melbourne, but not in older (unvaccinated) women, so it must be due to the vaccine.”

If you read that graph carefully, each datapoint was 3 months, making it look like a much longer study than it was. I followed the reference. That data was from a clinic that treats a specific population. After they vaccinated the population starting in 2007, they saw a decrease in genital warts in 2008 (that’s when the data ends). I would certainly hope to see some vaccine efficacy during in the period of one year! If you didn’t see anything, the vaccine would immediately be declared a dismal failure. These results are hardly startling. It’s long term efficacy that matters across a large population. Most of the rest of the slide deck regurgitates the data from the clinical trials which we’ve already covered to death. One thing that jumps out is the amount of ADRs from the Placebo. Do you think that it might just be because their “placebo” isn’t really one?

@Krebiozen “Also, you need to vaccinate 31 girls to prevent a case of CIN-2/3, 639 girls to save 1 life, and 14 girls to save 1 year of life, figures that are much lower than for other vaccines, which rather elegantly expresses what I have been trying to explain, perhaps somewhat inarticulately, about the value of the vaccine.”

You didn’t factor in the cost. That’s like saying I want to build and buy the safest car regardless of the cost. CDC Cost: Gardasil costs ~$300, DTaP ~$60, MMR ~40. That’s almost an order of magnitude more expensive than MMR. Public health can’t ignore cost as a criteria for deciding on initiatives.

@Krebiozen “I would suggest that it is HPV antibody testing and the use of safe sex or abstention in those who test positive that will be analogous to the use quarantine in the eradication of smallpox.”

I think the odds of success there are close to zero. People still engage in unsafe sex, even when the penalty is/was death from HIV/AIDS. Why would the fear of genital warts have a greater chance of success? People don’t require proof of an AIDS test today, let alone an HPV test. Call me a sceptic, but I just can’t see that flying unless you decided to create a police state where everyone had to carry around ID with test results on it.

@Shay “It’s a waste of money to vaccinate people with access to health care?…”

If you disagree with the Bach reference, then post an alternate financial model which supports your rhetorical fury.

@Shay “FYI, the vaccine is now offered by many health departments as part of the vaccination program for children from low-income families.”

Do you have stats to show it’s working? The state numbers from the CDC still don’t look so good. The point is that the CDC has to actually deliver the vaccine properly, or they are wasting their money. Hopefully they can clean up their early failure.

CDC Cost: Gardasil costs ~$300, DTaP ~$60, MMR ~40. That’s almost an order of magnitude more expensive than MMR.

You’re now reduced to whining about the cost of the vaccine while simultaneously, in effect, advancing the “Pap smears are better” argument? The incremental lifetime cost is effectively nothing. What’s the cost of treating cervical cancer?

You’re now reduced to whining about the cost of the vaccine while simultaneously, in effect, advancing the “Pap smears are better” argument?

If I understand correctly, the cost comparison is between (a) a vaccine of some form or (b) the SaneVax / Sin Hang Lee business model of “Pap smears plus regular payments from every woman regularly through her lifetime to SaneVax for a dodgy PCR test “.

@Mr Pink:

You didn’t factor in the cost. CDC Cost: Gardasil costs ~$300…That’s almost an order of magnitude more expensive than MMR. Public health can’t ignore cost as a criteria for deciding on initiatives.

Seriously?!?! Have you never heard of the expression “Prevention is better than cure”? It can cost tens of thousands of dollars to treat just one case of cervical cancer. Even if the patient survives, there can still be lasting damage. I read that Brooke Shields’s battle with cervical cancer permanently damaged her uterus and consequentially, her two daughters had to be delivered by C-Section. In addition, HPV has been implicated in cancers in males, and in cancers of the mouth and throat.
A $300-00 jab is looking like a very good, cost effective option.

don’t you think it’s a little disingenuous that Lee declares no conflicts of interest despite the fact the he has a clear financial interest in the LoTemp PCR system?

A thorough conflict-of-interest declaration would also include the direct competition between (a) vaccination campaigns that Lee and SaneVax have worked so hard to undermine, and (b) the program of regular PCR screening offered by Lee and SaneVax at $50 per person per test (possibly reimburseable).
http://www.businesswire.com/news/home/20100920005586/en/S.A.N.E.-Vax-Sin-Hang-Lee-MD-Offers

If you disagree with the Bach reference, then post an alternate financial model which supports your rhetorical fury.

Which would you rather purchase — a smoke detector or a brand-new house?

Prevention costs less than treatment. I have insurance and can afford to get treatment for diabetes and high cholesterol but I’d rather keep my weight under control; it’s cheaper in the long run. However, if you can’t be made to see how this makes sense from a medical standpoint, I’m not sure an argument from a business perspective is going to convince you.

You didn’t factor in the cost. CDC Cost: Gardasil costs ~$300…That’s almost an order of magnitude more expensive than MMR. Public health can’t ignore cost as a criteria for deciding on initiatives.

Are you seriously arguing that treatment for cervical or oropharyngeal cancer costs less than $300?

@Julian Frost “Seriously?!?! Have you never heard of the expression “Prevention is better than cure”? It can cost tens of thousands of dollars to treat just one case of cervical cancer. “

@Shay “Which would you rather purchase — a smoke detector or a brand-new house?”

Two almost identical strawmen. Did you people not read the context of the discussion? Krebiozen was comparing various vaccines and the vaccination/prevention ratio compared to other vaccines. Do I really need to point out that cost and ROI is one of the most important criteria when choosing public health initiatives? Arguing that I am against preventative measures is a strawman.

The Bach reference clearly outlines that in order for the preventative measure to be cost effective (i.e. positive ROI) we need to vaccinate the populations without access to health care because they have a higher risk of cervical cancer.

Unlike far more targeted preventative measures — like providing screening to high risk groups — you are advocating we pay for an unnecessary procedure for the whole population, the vast majority of whom are not at risk of anything.

Of course, if you people want to continue living in a fantasyland where you assume infinite funding — apparently you are in good company in America today — go ahead and keep drinking the kool-aid corporate america is feeding you.

@Krebiozen “I would suggest that it is HPV antibody testing and the use of safe sex or abstention in those who test positive that will be analogous to the use quarantine in the eradication of smallpox.”

That would not work. From the CDC: “As HPV infection is confined to the epithelium and infected cells are shed before cell death, natural HPV infection results in minimal host immune response and not all those infected have detectable antibodies”

@Grant “If Lee’s was done without the hospital’s approval, or in a way that the hospital did not approve, then perhaps the hospital would be less than happy with their name being on the papers. You’d have to ask them, really.”

Any luck getting a public statement from the “affiliated party” yet? All those allegations of fraud sound like a lot of hot air.

Mr Pink,

Regards “@Grant […] Any luck getting a public statement from the “affiliated party” yet? All those allegations of fraud sound like a lot of hot air.”

I wasn’t the person asking for a public statement. Nor did I make an “allegation of fraud”. You need to read more carefully. (It’s pretty rich how you accuse others of not reading carefully when you certainly aren’t yourself!)

I would remind you—again—that accusing people writing here of things they haven’t done and the various other silly put-downs you do with regularity won’t make you or Lee right.

@Mr Pink:

Do I really need to point out that cost and ROI is one of the most important criteria when choosing public health initiatives?

How ironic. You accuse me and Shay of strawmanning and yet you yourself straw man. The ROI on the HPV vaccine is excellent. We accused you of miscalculating the ROI.

The Bach reference clearly outlines that in order for the preventative measure to be cost effective (i.e. positive ROI) we need to vaccinate the populations without access to health care because they have a higher risk of cervical cancer.

A higher risk of cervical cancer, or a higher risk of dying from it? Also, treating a case of cervical cancer costs a ton of money, whether or not the patient has access to health care. It’s still cheaper to vaccinate.

A quick response to Mr. Pink as I am currently otherwise occupied:

That would not work. […] not all those infected have detectable antibodies

Not all, but most do. I am suggesting this as part of a larger strategy to eradicate HPV. As I wrote before, it would require a long time, and quite probably technologies not yet developed. In theory all we have to do is reduce the average number of people each infected individual infects to less than one for long enough; there are several different and complementary ways of doing this. They have to be tailored to HPV and its modes of transmission just as the different complementary methods used to eradicate smallpox were.

@Pink

Nice dodge. I say again, are you seriously arguing that a $300 vaccination is more expensive than treatment for cancer?

Since not veryone infected with HPV will develope cancer as a results, I think he’s arguing that $300 dollars per person to vaccinate enough people to prevent a case of crvical cancer costs more than treating that case of cancer.

I don’t know if that’s true–the cost of treating cancer can easily run into 6 figures–but even if it were that >isn’t an argument against HPV vaccination: it’s instead an argument in favor of reducing the per person cost of HPV vaccination.

Since not veryone infected with HPV will develope cancer as a results, I think he’s arguing that $300 dollars per person to vaccinate enough people to prevent a case of crvical cancer costs more than treating that case of cancer.

It’s still a drop in the bucket amortized against the extant cost of screening.

herr doktor bimler,

Just to be clear, my previous objections (#645) were to Mr Pink getting confused about who wrote what again.

@Julian Frost “We accused you of miscalculating the ROI.” … “It’s still cheaper to vaccinate.”… “A higher risk of cervical cancer, or a higher risk of dying from it? “

It wasn’t my calculation, that came from the reference which you didn’t read very carefully. It says: “Those who are more affluent and have access to regular Pap testing are at low risk of the disease because the test, when properly done, is highly effective.” That’s disease, not death.

@shay “Nice dodge. I say again, are you seriously arguing that a $300 vaccination is more expensive than treatment for cancer?”

You appear clueless on how to measure the ROI of a public health measure. Read the post from JGC who gets it.

@jgc “I don’t know if that’s true–the cost of treating cancer can easily run into 6 figures–but even if it were that isn’t an argument against HPV vaccination: it’s instead an argument in favor of reducing the per person cost of HPV vaccination.”

The model was just below the threshold of economically attractive (< 50K) if only 12 year olds were vaccinated. It's over 6 figures if you catch up to age 26. That's why Bach points out that ineffective delivery makes the program not economically attractive. Also, that number was based on the rosy assumption of lifelong immunity. The cost is well over 6 figures if immunity lasts only 10 years as they project only a marginal reduction of 2% over current screening in that scenario.

This is just a model based on a whole host of assumptions because there is no efficacy data available yet. I don't think there has been a single early vaccine cost model (i.e. prior to seeing actual efficacy in real life) that didn't grossly underestimate the cost. 1 shot of MMR was supposed to give immunity for life too. Even 2 shots still don't prevent a mumps outbreak today blowing the older cost calculations out of the water.

Given that Merck just lost patent protection on one of their biggest drugs (Singular @ 5.5B annual revenue in 2011), I doubt they will be dropping the price anytime soon.

@Krebiozen “Not all, but most do. I am suggesting this as part of a larger strategy to eradicate HPV. As I wrote before, it would require a long time, and quite probably technologies not yet developed.”

LOL, most? Did you check the confidence interval on that 51% number? A more accurate term would have been half. The “technologies not yet developed” make this sound an awful lot like wishful or magical thinking. According to our host, that puts it right up there with homeopathy.

Oh, sorry, “LOL.” I’d hate to appear not to have a measure of technological sophistication.

It wasn’t my calculation, that came from the reference which you didn’t read very carefully. It says: “Those who are more affluent and have access to regular Pap testing are at low risk of the disease because the test, when properly done, is highly effective.” That’s disease, not death.

You didn’t read the underlying reference, did you?

I suppose I should add, from the original (PDF),

Overall, Blacks and non-Hispanic whites have
been noted to have the highest cervical cancer screening rates among all ethnic groups, whereas Hispanics and AA/AN/PI women are less likely to have ever had a Pap or to have been screened within the past 3 years.

[Footnotes omitted, emphasis added.]

@Mr Pink:

“Those who are more affluent and have access to regular Pap testing are at low risk of the disease because the test, when properly done, is highly effective.”

A pap smear detects the disease in the early stages where treatment is cheapest and most likely to be effective. However, it’s still more expensive than the vaccination. The ROI still favours the vaccine.

Mr. Pink,
I’m starting to simply repeat myself, which is a waste of everyone’s time. I think there is ample evidence to support the assumption that Gardasil will prevent cervical and other cancers, and that it will prove to be a safe, effective and cost-effective intervention in the long term. Perhaps we should reconvene here in a decade or two to assess how well it has done.

Anyway, I note that you appear to have changed your position from:

There isn’t an ounce of quality evidence showing the vaccine has or will ever reduce the incidence of cervical cancer. That’s why people should avoid Gardasil, not because of one linked death.

To:

The point is that the CDC has to actually deliver the vaccine properly, or they are wasting their money. Hopefully they can clean up their early failure.

Which is progress of sorts.

I will address this cheap shot:

The “technologies not yet developed” make this sound an awful lot like wishful or magical thinking. According to our host, that puts it right up there with homeopathy.

I originally wrote, “in the future we may be able to produce effective vaccines against all other high risk strains and eliminate HPV the same way smallpox has been eliminated”. I have stated that I might be being “unrealistically optimistic” and that this might require “technologies not yet developed” . We know that polyvalent HPV vaccines are currently undergoing RCTs, and that antiviral drugs targeting HPV are under development. As I pointed out above, I am not alone in thinking it might be possible to eradicate HPV eventually.

Wishful thinking? Perhaps.
Magical thinking? Certainly not .

One more thing – I was getting HPV testing confused with HPV antibody testing earlier. Testing for HPV is considerably more sensitive than cytology though less specific. There’s a recent paper on the future of cervical cancer screening here if anyone’s interested. It concludes:

It is entirely conceivable that women will no longer die from cervical cancer in the near future, thanks to global effective screening and preventive efforts through widespread HPV vaccination.

I think that’s worth pursuing.

Mr. pink, just for teh record I don’t agree that the ROI for the vaccine is insufficient–quite the opposite. One doesn’t have to prevent very many cases of cervical cancer to achieve cost effectiveness.

As for Bach’s claims that ineffective delivery making the program economicallu unattractive, that’s again not an argument against immunization–it’s an argument in favor of optimizing the delivery program.

with regard to pap smears versus immunization, fail to see the relevance to this discussion. Regular pap screening is capable only of detecting cervical cancer once it arises, while immunization prevents its occurrence. Would you similarly argue that there’s no need to expend resources preventing the sale of guns to convicted felons, long as we can accurately determine after the fact when a felon has purchased a firearm?

You appear clueless on how to measure the ROI of a public health measure. Read the post from JGC who gets it.

Yes, JCG gets it…you, on the other hand, don’t.

Krebiozen, “I’m starting to simply repeat myself, which is a waste of everyone’s time.” – similar for me. I felt sometime ago (what is it now, two weeks ago?) that it got to the point where all I could suggest was for him to re-read earlier comments as he clearly wasn’t taking things in and was just pushing his own barrow.

@narad “You didn’t read the underlying reference, did you?”

You stopped reading after you found the quote you wanted. In the same paragraph: “Other studies have suggested that [b]race/ethnicity is likely not the primary mediator of disparities in cervical cancer screening rates[/b]… This is evidenced by the fact that the effect of race is significantly reduced or eliminated after controlling for these factors.”

Further down in the study: “In a number of these studies, socio-economic position has been noted to explain differences in cervical cancer screening rates better than race/ethnicity.”

Of course, the heart of the matter is put to rest further down: “Lack of access to health care has been correlated with reduced cervical cancer screening and treatment. In most studies, health care access is measured by insurance status or having a usual source of care. Having insurance, particularly private insurance, has been positively associated with cervical cancer screening, earlier stage at diagnosis, receipt of guideline-based therapy, and improved survival.”

Or further: “An evaluation of three interventions to increase cervical cancer screening rates in a multi-ethnic sample found that having private insurance and/or a usual source of care were the strongest predictors of cervical cancer screening behavior.”

Of course, the study starts out by saying: “Screening conducted every 3 years among women aged 20 to 64 reduces the cumulative incidence of ICC by 91% according to data from the U.S. Preventive Services Task Force.”

This all fully supports the Bach quote that used the reference: “Those who are more affluent and have access to regular Pap testing are at low risk of the disease because the test, when properly done, is highly effective.” Again, I’ll repeat my original assertion, it reduces BOTH disease and mortality, NOT only mortality as Julian Frost suggested.

@Julian Frost “A pap smear detects the disease in the early stages where treatment is cheapest and most likely to be effective. However, it’s still more expensive than the vaccination. The ROI still favours the vaccine.”

To keep insisting that in the face of evidence to the contrary is pretty illogical. I’m sure the authors of the financial model would be happy to address the concerns of Julian Frost based on the fact that “he says so”.

@JGC “As for Bach’s claims that ineffective delivery making the program economicallu unattractive, that’s again not an argument against immunization–it’s an argument in favor of optimizing the delivery program.”

Bach does make the argument for better delivery, but the argument for cancellation is also valid for consideration. In post #565 I raised this to point out how marginal the ROI was for the whole program, and that given the failure of distribution it was providing negative ROI.

@JGC “Regular pap screening is capable only of detecting cervical cancer once it arises, while immunization prevents its occurrence. Would you similarly argue that there’s no need to expend resources preventing the sale of guns to convicted felons, long as we can accurately determine after the fact when a felon has purchased a firearm?”

Not true. Pap smears with proper followup is a preventative measure which reduces the incidence of ICC (invasive cervical cancer). “Screening conducted every 3 years among women aged 20 to 64 reduces
the cumulative incidence of ICC by 91% according to data from the U.S. Preventive Services Task Force.”
(Akers AY, Newmann SJ, Smith JS. Factors underlying disparities in cervical cancer incidence, screening, and treatment in the United States. Curr Probl Cancer 2007; 31: 157–81.) That’s why the ROI on the vaccine is so marginal and is also highly sensitive to several factors including efficacy and length of immunity.

@Shay “Yes, JCG gets it…you, on the other hand, don’t.”

That’s ironic coming from the person who inferred that the cost of preventing a case of cervical cancer is $300 based on vaccination. You’re only off by a couple of orders of magnitude on that one.

@Krebiozen

“Which is progress of sorts.”

Thanks for pointing out my ommision: “The point is that the CDC has to actually deliver the vaccine properly, or they are wasting their money by their own calculations. Hopefully they can clean up their early failure.”

” I am not alone in thinking it might be possible to eradicate HPV eventually.”

All he did was say that it was theoretically possible but he doesn’t express any confidence in it. He can’t even forsee a future where screening is not required. You might note that he also confirms that screening requirements won’t change based on the current vaccines. That borders on magical.

“One more thing – I was getting HPV testing confused with HPV antibody testing earlier. Testing for HPV is considerably more sensitive than cytology though less specific. There’s a recent paper on the future of cervical cancer screening here if anyone’s interested. It concludes: “It is entirely conceivable that women will no longer die from cervical cancer in the near future, thanks to global effective screening and preventive efforts through widespread HPV vaccination.””

The expert you noted above was also quite vehement that screening was required to eliminate the incidence of cervical cancer.

I will point out now that Dr Lee’s technology provides the most accurate HPV screening which can be performed in community hospitals at low cost compared to the less accurate assays which are run by expensive labs. Contrary to Bimler’s whining, your own references and quotes demonstrate quite clearly that he has competition or conflict of interest with the vaccine since all of the experts are universally saying that effective screening is critical in reducing the incidence of the cancer regardless of vaccination.

Thank you very much for making that point crystal clear for all to see.

One last thought for you: Since the vaccine will only prevent some of the incidence of cancer (certain strains), your quote above implies that the screening will be 100% effective for the rest. Why do you suppose that screening wouldn’t be as effective for vaccine strains? Cognitive dissonance anyone?

CORRECTION:
I will point out now that Dr Lee’s technology provides the most accurate HPV screening which can be performed in community hospitals at low cost compared to the less accurate assays which are run by expensive labs. Contrary to Bimler’s whining, your own references and quotes demonstrate quite clearly that he has NO competition or conflict of interest with the vaccine since all of the experts are universally saying that effective screening is critical in reducing the incidence of the cancer regardless of vaccination.

Pink, do you recall saying this?

Cervical cancer is primarily a disease of the poor. In the US, the cervical cancer mortality rates in the poor states can be double that of the wealthy ones. The cost justification of the program assumes that the poor get the vaccine…. Unfortunately health care distribution in the US is skewed to the wealthy and the vaccine distribution is the same making calling into question the cost justification.

Now, do you remember this?

Overall, Blacks and non-Hispanic whites have been noted to have the highest cervical cancer screening rates among all ethnic groups….

Black in America directly correlates with lower socioeconomic status. (Nationwide, however, there is a slight disproportionality toward Whites in Medicaid coverage.)

Now, please explain the figure within the framework of your reasoning. You are plainly arguing against Gardasil, now with a slapdash economic construction, but what are you arguing for?

I will point out now that Dr Lee’s technology provides the most accurate HPV screening which can be performed in community hospitals at low cost compared to the less accurate assays which are run by expensive labs.

Are you insane? You think that “community hospitals” are going to start performing some weird-ass nested PCR?

Moreover, what does this even have to do with HPV screening? As you may recall, Lee’s “technology” is for detecting deadly Gardasil DNA brain residues.

Oh, right, I forgot that he’s selling it by way of “SaneVax”:

Submit the specimen or its residues (at least 5% of the original collection) in a Cytyc or SurePath liquid-based cytology vial in a small zip-lock bag with this requisition in a padded envelope…. Specimens without a valid SaneVax No. will not be processed.

The point remains elusive.

@Mr Pink:
“A pap smear detects the disease in the early stages where treatment is cheapest and most likely to be effective. However, it’s still more expensive than the vaccination. The ROI still favours the vaccine.”
To keep insisting that in the face of evidence to the contrary is pretty illogical. I’m sure the authors of the financial model would be happy to address the concerns of Julian Frost based on the fact that “he says so”.
It’s not just I who says so.
Cost of treating early -stage cancer: $ 7,370.
Cost of the jab: $360.
Source (PDF): http://www.michigancancer.org/pdfs/mdchfactsheets/cervcainmichfact%20sheet-jan07.pdf
The maths says that 20 Gardasil vaccinations are cheaper than one early-stage treatment. But introduce the fact that HPV has been implicated in numerous other cancers and the ROI is even better.
It’s still cheaper to vaccinate.

@Narad

You are plainly arguing against Gardasil, now with a slapdash economic construction, but what are you arguing for?

Dr Lee is awesomesauce, quite obviously.

This seems to be Mr Pink’s response to my penultimate comment (#641) –a link to a press release from Lee and SaneVax in which they complain about the existence of competition.

If only they would glom onto fan death. (Yes, I know, wrong nationality, but still.)

Mr. Pink,

Thanks for pointing out my ommision: “The point is that the CDC has to actually deliver the vaccine properly, or they are wasting their money by their own calculations. Hopefully they can clean up their early failure.”

You have moved from suggesting that, “people should avoid Gardasil”, to complaining that the problem is the CDCs failure to vaccinate enough people. Who was it that mentioned cognitive dissonance?

” I am not alone in thinking it might be possible to eradicate HPV eventually.”

All he did was say that it was theoretically possible but he doesn’t express any confidence in it. He can’t even forsee a future where screening is not required. You might note that he also confirms that screening requirements won’t change based on the current vaccines. That borders on magical.

Did you read the article I linked to at #628?

“There are new vaccines being planned that will vaccinate against nine types. If they are successful, there should be no need to screen women that have been vaccinated at all. That’s the long-term future: vaccination and no screening. After about 50 years, we could see cervical cancer disappearing”.

That seems pretty confident to me, about an eventual end to screening too. How does expecting the polyvalent vaccines currently undergoing clinical trials and the antiviral treatment for HPV currently under development to be successful even border on “magical thinking”?

The expert you noted above was also quite vehement that screening was required to eliminate the incidence of cervical cancer.

Where have I ever suggested that it would not be? If you are so concerned about the costs, look at them over the very long-term when HPV and cervical cancer have been eradicated and there is no longer any need for screening, treatment and, ultimately, vaccination. How much would smallpox have cost over the last 35 years if it hadn’t been eradicated?

One last thought for you: Since the vaccine will only prevent some of the incidence of cancer (certain strains), your quote above implies that the screening will be 100% effective for the rest. Why do you suppose that screening wouldn’t be as effective for vaccine strains? Cognitive dissonance anyone?

You appear to have an odd habit of rigid black and white thinking. I am suggesting that neither vaccination nor screening would be 100% effective on their own, but together with technologies currently being developed they could result in HPV eradication. Even if efforts to achieve this “pipe dream” fail, they can be expected to result in a dramatic fall in incidence of cervical cancer.

Missed an apostrophe in “CDC’s”. Better than a superfluous one, but I isn’t illiterate, honest.

@Krebiozen:

How much would smallpox have cost over the last 35 years if it hadn’t been eradicated?

I read somewhere (don’t remember) that the elimination of smallpox pays for itself every 26 days. So, billions of dollars would be my guess.

Mr Pink’s reasoning seems to be that poorer women are less likely to get regular screening for cervical cancer, therefore there is no reason for then to be vaccinated since that would only reduce the number of cancers that they aren’t being screened for.

Do I have that right?

That’s ironic coming from the person who inferred that the cost of preventing a case of cervical cancer is $300 based on vaccination. You’re only off by a couple of orders of magnitude on that one.

That’s ironic coming from someone who keeps using “ROI” and “orders of magnitude” with no indication you understand what they mean.

As has been pointed out already, you have shifted your argument from Gardasil doesn’t work to other things work better and besides it’s too expensive. Citations needed, as what you have provided so far doesn’t support your argument.

(Pap smears as a cancer treatment. Hoo, boy).

Cookie please.

Still waiting for mr. or mrs Floyd in addition to mr. Pink.

@ LW:

I might argue the reverse: they need it more because they can’t access screening.
But then, that’s just me.

I don’t understand the reasoning here – since pap smears & even testing doesn’t actually prevent cervical cancer………yet the vaccine does prevent the disease (so people who don’t have access to screening or just don’t screen, are less likely to get cervical cancer in the first place).

Mr. Pink – care to explain what the hell you’re talking about? Because if there was a vaccine against breast cancer, it sounds like you’d be arguing that more mammograms would be better than prevention…….

@Denise Walter, “I might argue the reverse: they need it more because they can’t access screening.  But then, that’s just me.”

That’s what you think. It’s what I think too. But it doesn’t seem to be what Mr Pink thinks. 

While pondering this I found something interesting, from a 2008 article, ‘The World Health Organization and global smallpox eradication’

Strikingly, not all public health and medical officials were supportive of smallpox eradication, as many considered the goal an impossible one and, therefore, a misguided waste of scarce resources.

The World Health Assembly Resolution WHA11.54, an undertaking to eradicate smallpox globally was accepted in 1959. The last case of wild smallpox was in 1977. I’m not saying that HPV can be eradicated in less than 20 years, but without the vision and determination shown by public health officials (and many others), we would still be seeing millions dying from smalllpox.

Another interesting (to me, anyway) snippet of history, from a review of ‘Smallpox—The Death of a Disease: The Inside Story of Eradicating a Worldwide Killer’ by D. A. Henderson, the sacrificial lamb described here:

Because the WHO director-general believed that eradication was impossible, he insisted on putting an American in charge so that when the program failed, the United States would be held responsible for the debacle. Henderson was chosen as the sacrificial lamb, and in October 1966, aged 39 and with only 10 years of experience in public health, he flew to Geneva to lead what looked to be a quixotic effort.

I’d say the WHO DG shot himself in the foot.

@Lawrence “I don’t understand the reasoning here – since pap smears & even testing doesn’t actually prevent cervical cancer………yet the vaccine does prevent the disease (so people who don’t have access to screening or just don’t screen, are less likely to get cervical cancer in the first place).
Mr. Pink – care to explain what the hell you’re talking about? Because if there was a vaccine against breast cancer, it sounds like you’d be arguing that more mammograms would be better than prevention…….”

Lawrence, this isn’t my argument, it’s the argument of the evidence I’m quoting. Read the Akers reference I provided in post #665. Screening (pap tests) and followup reduces the INCIDENCE of cancer by an average of 91%. Good screening is even more effective at reducing the incidence of the disease. The vaccine is projected (since it hasn’t be shown to reduce any cancer yet) to reduce the incidence of cancer. Since the vaccine only covers several strains, the experts all recommend implementing the best screening available (which consists of HPV genotyping) to reduce the incidence of cancer caused by non vaccine strains. There is a huge overlap between pap tests and the vaccines, in that they both prevent the same types of cancer. The difference is that screening actually prevents cancer from all strains, while the vaccine is theoretically supposed to prevent a few more cases of vaccine strains only. But even this conclusion is dubious because the better screening which is available today (HPV genotyping) will further improve the rates of screening and prevention. At that point, the few extra cases vaccination might theoretically prevent, will only come true if the most optimisitic assumptions of efficacy and 100% lengevity are true. The early population data comparing vaccinated and unvaccinated populations in real life (2012 Athena study) gives us a hint that the vaccine prevents only a few percent of infections which is a huge deviation from the efficacy estimates.

If the strategy seems confusing — confusing is a generous word IMO — it’s because it doesn’t make a whole lot of sense unless you’re the one selling the vaccine.

@narad “Are you insane? You think that “community hospitals” are going to start performing some weird-ass nested PCR?”

Just because you don’t understand it doesn’t mean it’s weird or complicated. The heavily downloaded article describes both the methods and the efficacy show that there is quite a bit of interest and others get it even if you don’t.

@narad “Now, please explain the figure within the framework of your reasoning. You are plainly arguing against Gardasil, now with a slapdash economic construction, but what are you arguing for?”

Are you dense? Re-read #665. Your graph is followed by the revelation that the correlation disappears when confounding factors are corrected. Bach’s reference of Ackers et al is completely valid.

@LW “Mr Pink’s reasoning seems to be that poorer women are less likely to get regular screening for cervical cancer, therefore there is no reason for then to be vaccinated since that would only reduce the number of cancers that they aren’t being screened for. Do I have that right?”

No you do not. Denice has it right. The vaccine was designed primarily for treatment of the developing world and people who do not have access to good screening and followup. Read Ian Frazer’s quotes. He’s the guy who kicked the whole thing off and he did it for the developing world (God’s gift to women: The HPV vaccine). The Bach reference describes that the US program is inefficient (i.e. won’t be cost effective) because it’s vaccinating the women who need the vaccine the least (those with access to good screening and followup). There is a correlation between low average income and low vaccine uptake by state. That means that the people who need the vaccine the most (i.e. the ones for whom it is most cost effective) aren’t getting it. That’s the failure of the US vaccine program by it’s own measured objectives. Read the Bach reference for more details. According to Bach, the failure is even more embarrassing because it was predicted prior to the start of the program.

@Shay “As has been pointed out already, you have shifted your argument from Gardasil doesn’t work to other things work better and besides it’s too expensive. Citations needed, as what you have provided so far doesn’t support your argument.”

I did not shift my argument. I made three independent ones. My first argument is that Gardasil has no demonstrated efficacy against the target endpoint. That is a fact because the vaccine has not been around long enough to know if it works against cancer in a real population. All of the studies to date are based on surrogate outcomes. A second argument is that even using the most ROSY projections (from the reference I provided), the vaccine program in the United States has a negative ROI due to a failure in the delivery system (they have not vaccinated the highest risk populations). A third argument, is that even if the ROSY projections are all true, the ROI is so marginal that public health should spend the money elsewhere on a program with better ROI.

I have provided references for those arguments. Your implication that it costs $300 to prevent a case of cervical cancer indicates that it is you who have no clue on the cost justification of the program. I’ll also note that you have not provided a single reference for your fantastical claim. My references start in comment #565. You might actually learn something if you read them.

@Krebiozen

You have moved from suggesting that, “people should avoid Gardasil”, to complaining that the problem is the CDCs failure to vaccinate enough people.

No, I have provided three independent arguments all of which are valid. My first argument is that Gardasil has no demonstrated efficacy against the target endpoint. That is a fact because the vaccine has not been around long enough to know if it works against cancer in a real population. All of the studies to date are based on surrogate outcomes. A second argument is that even if we assume it works and use the most ROSY projections (from the reference I provided), the vaccine program in the United States has a negative ROI due to a failure in the delivery system (they have not vaccinated the highest risk populations). A third argument, is that even if we assume it works and the ROSY projections are all true and the delivery failure is corrected, the ROI is so marginal that public health should spend the money elsewhere on a program with better ROI.

There is no conflict between those arguments.

That seems pretty confident to me, about an eventual end to screening too. How does expecting the polyvalent vaccines currently undergoing clinical trials and the antiviral treatment for HPV currently under development to be successful even border on “magical thinking”?

Really? He says “IF they will be successful”. He doesn’t even indicate if he thinks they will be successful or not. In fact, he follows up with this: “Even for girls vaccinated before this age with the current vaccine, there will be a need for some screening to protect from cancers caused by HPV types not in the vaccine, so screening is here to stay for the foreseeable future.
He can’t even foresee a future without screening! That doesn’t sound too confident to me.

Where have I ever suggested that it would not be?

I didn’t say you suggested it. That sentence led into the next paragraph: “I will point out now that Dr Lee’s technology provides the most accurate HPV screening which can be performed in community hospitals at low cost compared to the less accurate assays which are run by expensive labs. Contrary to Bimler’s whining, your own references and quotes demonstrate quite clearly that he has competition or conflict of interest with the vaccine since all of the experts are universally saying that effective screening is critical in reducing the incidence of the cancer regardless of vaccination.

How much would smallpox have cost over the last 35 years if it hadn’t been eradicated?

Your analogy is invalid. Smallpox is not at all like HPV. If you want to use prior vaccination as evidence, it is far more likely HPV will NOT be eradicated given the vast number of vaccination programs and only 1 successful eradication. I don’t accept an argument based on wishful thinking and no plausible mechanism for success, and neither should you.

You appear to have an odd habit of rigid black and white thinking. I am suggesting that neither vaccination nor screening would be 100% effective on their own, but together with technologies currently being developed they could result in HPV eradication. Even if efforts to achieve this “pipe dream” fail, they can be expected to result in a dramatic fall in incidence of cervical cancer.

You misread my argument — now I’m repeating myself. I pointed out the quote from the reference YOU provided states that the combination of vaccination and screen could eliminate cervical cancer: “If vaccination were to be combined with HPV screening (which is much more sensitive than the currently used Pap smear test), then eventually the cancer would disappear in those countries that had successfully implemented national programmes.” It seems you miss a lot of little important details in your own references. Don’t accuse me of being black and white, when I’m actually reading the references you’re providing.

#686, LW:

doesn’t seem to be what Mr Pink thinks.

Objection? Assumes facts not in evidence (that Mr Pink actually thinks).

Are you dense?

I’m a Bose condensate, baby. I am not ionized and I possess not valence. Nothing “disappears.”

So vaccination doesn’t get to the poorest women in America (even though it’s provided by county health departments) but instead of implementing a better vaccination program what we should do is to provide *much* more screening, including piping plenty of work to Dr Lee.

Mr. Pink,

My first argument is that Gardasil has no demonstrated efficacy against the target endpoint. That is a fact because the vaccine has not been around long enough to know if it works against cancer in a real population. All of the studies to date are based on surrogate outcomes.

That’s not an actual argument, is it? I agree that “Gardasil has no demonstrated efficacy against the target endpoint” for the reasons you list and that we have discussed ad nauseam. My argument is that it is perfectly reasonable to expect Gardasil to demonstrate efficacy against the target endpoint, invasive cervical cancer, in the long term because (i) Gardasil prevents HPV-16 and HPV-18 in those not already infected, (ii) HPV infection is a necessary precursor of all, or almost all, CIN (and AIS) and cervical cancer and (iii) treating those surrogate outcomes (CIN and AIS) prevents invasive cervical cancer (as you yourself have pointed out). There is a large body of evidence that supports all three of these assertions.

A second argument is that even if we assume it works and use the most ROSY projections (from the reference I provided), the vaccine program in the United States has a negative ROI due to a failure in the delivery system (they have not vaccinated the highest risk populations).

Again, I don’t see an actual argument. The vaccine has a negative ROI due to poor delivery therefore what? We should throw up our hands in despair and abandon HPV vaccination entirely? Or should we make efforts to improve vaccine delivery to those who need it the most? Personally I am in the UK so the CDC’s failings don’t matter as much to me as the NHS’s implementation of Gardasil (now replacing Cervarix) which is going very well.

The same goes for the fact that Gardasil protects mostly against 70% of the cancer-causing strains. That’s an argument for polyvalent vaccines, not against vaccination.

A third argument, is that even if we assume it works and the ROSY projections are all true and the delivery failure is corrected, the ROI is so marginal that public health should spend the money elsewhere on a program with better ROI.

At last an actual argument! I agree that you could argue that the money might be better spent elsewhere, though I (and public health authorities around the world) disagree with you. As I pointed out somewhere above, public health is fraught with uncertainty and is always a gamble to some extent; it is very rare, if it ever occurs, that you have hard evidence to definitively prove what the outcome of public health measures will be in the long term, and the unexpected does sometimes occur. That’s one reason I find public health so interesting.

BTW, as I have also pointed out, there is more to preventing disease than ROI. The way you equate a case of CIN or AIS treated surgically with one prevented by vaccination suggests you don’t quite appreciate this.

There is no conflict between those arguments.

The only actual argument I can see there is about cost efficacy. You did initially suggest that “people should avoid Gardasil”, and you do now appear to be suggesting that the problem with Gardasil is that too few, not too many, are getting it. Perhaps you would like to clarify your position..

That seems pretty confident to me, about an eventual end to screening too. How does expecting the polyvalent vaccines currently undergoing clinical trials and the antiviral treatment for HPV currently under development to be successful even border on “magical thinking”?

Really? He says “IF they will be successful”. He doesn’t even indicate if he thinks they will be successful or not. In fact, he follows up with this: “Even for girls vaccinated before this age with the current vaccine, there will be a need for some screening to protect from cancers caused by HPV types not in the vaccine, so screening is here to stay for the foreseeable future.” He can’t even foresee a future without screening! That doesn’t sound too confident to me.

There’s that black and white thinking again. I originally wrote, “in the future we may be able to produce effective vaccines against all other high risk strains and eliminate HPV the same way smallpox has been eliminated”. You claimed this is “a pipe dream” i.e. that it is impossible, equivalent to a drug-induced delusion. It is quite clear that Professor Cuzick agrees with me. What do you think he meant by, “That’s the long-term future: vaccination and no screening”?

Where have I ever suggested that it would not be?

I didn’t say you suggested it. That sentence led into the next paragraph: “I will point out now that Dr Lee’s technology provides […]

I see, so it was just a non sequitur you used as an excuse for plugging Dr Lee’s products.

How much would smallpox have cost over the last 35 years if it hadn’t been eradicated?

Your analogy is invalid. Smallpox is not at all like HPV. If you want to use prior vaccination as evidence, it is far more likely HPV will NOT be eradicated given the vast number of vaccination programs and only 1 successful eradication.

It wasn’t intended as an analogy, it is an example of how public health measures can have very much greater ROI over the long term than they do in the short term. Clearly smallpox and HPV are very different and strategies to eradicate HPV will differ greatly from those that succeeded with smallpox. I don’t see that as a reason not to attempt it, especially when the most likely outcome, even if we fail, is a large reduction in morbidity and mortality.

I don’t accept an argument based on wishful thinking and no plausible mechanism for success, and neither should you.

My argument was that “in the future we may be able to […] eliminate HPV” (my emphasis). That is based on the development of polyvalent vaccines that already exist and are going through clinical trials, screening technologies that already exist and antiviral drugs that are under development. Those are extremely plausible mechanisms, not wishful thinking.

You appear to have an odd habit of rigid black and white thinking. I am suggesting that neither vaccination nor screening would be 100% effective on their own, but together with technologies currently being developed they could result in HPV eradication. Even if efforts to achieve this “pipe dream” fail, they can be expected to result in a dramatic fall in incidence of cervical cancer.

You misread my argument — now I’m repeating myself. I pointed out the quote from the reference YOU provided states that the combination of vaccination and screen could eliminate cervical cancer: “If vaccination were to be combined with HPV screening (which is much more sensitive than the currently used Pap smear test), then eventually the cancer would disappear in those countries that had successfully implemented national programmes.”

I don’t follow your argument here. To clarify this, what you wrote was:

Since the vaccine will only prevent some of the incidence of cancer (certain strains), your quote above implies that the screening will be 100% effective for the rest. Why do you suppose that screening wouldn’t be as effective for vaccine strains? Cognitive dissonance anyone?

A minor niggle, the “quote above” you referred to was actually:

“It is entirely conceivable that women will no longer die from cervical cancer in the near future, thanks to global effective screening and preventive efforts through widespread HPV vaccination.””

Not, “If vaccination were to be combined with HPV screening (which is much more sensitive than the currently used Pap smear test), then eventually the cancer would disappear in those countries that had successfully implemented national programmes.” The current vaccine doesn’t cover all cancer-causing strains, but future vaccines will. Testing for HPV is considerably more sensitive than pap screening but it is less specific. Clearly eradication will require an ongoing and responsive strategy as progress against HPV is made.

It seems you miss a lot of little important details in your own references. Don’t accuse me of being black and white, when I’m actually reading the references you’re providing.

It is possible I have missed some details, as I waded through most of the HPV vaccine literature a couple of years ago and have only skimmed through them to refresh my memory more recently. However, you do appear to have a habit of focusing on unimportant details while missing the bigger picture.

A third argument, is that even if the ROSY projections are all true, the ROI is so marginal that public health should spend the money elsewhere on a program with better ROI.

Taking into consideration that in the US, public health ROIs are outcome-based, not revenue-based, what other program offers a better ROI with regard to protection against HPV?

@LW “So vaccination doesn’t get to the poorest women in America (even though it’s provided by county health departments) but instead of implementing a better vaccination program what we should do is to provide *much* more screening, including piping plenty of work to Dr Lee.”

Don’t take my word for it. The latest stats (at the CDC) show some improvement in overall coverage, but there is still a large disparity between the states. As for screening, just follow the expert recommendations. Krebiozen linked to one expert. Ackers et al says the same thing. Improved screening based on HPV genotyping is pretty much a unanimous recommendation. WRT Dr Lee, you don’t seem to understand the technology or the motives. Dr Lee doesn’t want the work, he wants it to be done at low cost in the local hospitals instead of leaving it to the big labs where they will charge you a lot more.

@Shay “Taking into consideration that in the US, public health ROIs are outcome-based, not revenue-based, what other program offers a better ROI with regard to protection against HPV?”

I’m not sure where you are getting your definitions. Check out slide 12. http://works.bepress.com/cgi/viewcontent.cgi?article=1083&context=glen_mays
HPV screening (vs pap tests) is universally recommended and has a very high ROI.

@Krebiozen

That’s not an actual argument, is it?

It was originally stated in the context of your original assertion and you argued against it in post 525. “Disingenous nonsense (PDF)”.

My argument is that it is perfectly reasonable to expect Gardasil to demonstrate efficacy against the target endpoint, invasive cervical cancer, in the long term because (i) Gardasil prevents HPV-16 and HPV-18 in those not already infected, (ii) HPV infection is a necessary precursor of all, or almost all, CIN (and AIS) and cervical cancer and (iii) treating those surrogate outcomes (CIN and AIS) prevents invasive cervical cancer (as you yourself have pointed out).

I have summarized the issues with your assumptions:
i) You are relying on historically unreliable regulatory studies AND the initial real population data differs significantly
ii) Most CIN2 (which is the only outcome they actually measured) regresses naturally. You don’t know why some small number of cases progress so you can’t assume those cases would have been vaccine preventable.
iii) Treatment of CIN2 has no bearing on your argument. Like I said in ii) it’s not a good surrogate.

Again, I don’t see an actual argument.

In post #547, you stated: “Even if the effectiveness of these vaccines was half that found in clinical trials, they would still be well worth using as a means of reducing morbidity and mortality.” My response is an argument against that now proven ridiculous assumption from a public health perspective. However, I can also independently make the argument that Public Health is wasting money on the program and that is the supporting point.

Personally I am in the UK so the CDC’s failings don’t matter as much to me as the NHS’s implementation of Gardasil (now replacing Cervarix) which is going very well.

You make the statement but bring no evidence to the table. Who is at greatest risk in the UK (i.e. those that aren’t taking advantage or getting good screening and followup) and are they getting the vaccine? You own public health’s decision to originally go with Ceravix is baffling — unless you consider who was selling it of course — to say the least so I hardly have confidence they’re making any good decisions. I also understand that NHS has bungling some VERY expensive programs over the past few years, so trusting them to spend your money wisely is hardly a good choice.

As I pointed out somewhere above, public health is fraught with uncertainty and is always a gamble to some extent; it is very rare, if it ever occurs, that you have hard evidence to definitively prove what the outcome of public health measures will be in the long term, and the unexpected does sometimes occur.

Yes, you talked about gambles early on. You sound more like a wealth manager selling someone on an IPO of a new company that has no history or background. Even worse, your best case scenario is an outcome that is so narrowly positive that there is no contingency. That’s a bad gamble in most books.

That’s one reason I find public health so interesting.

Your being the UK lends some insight into why you seem argue for public health decisions without consideration of cost. In the UK you have a heavily funded public programs and people often forget that it’s coming out of your taxes. I won’t even go into the money the NHS wastes.

BTW, as I have also pointed out, there is more to preventing disease than ROI. The way you equate a case of CIN or AIS treated surgically with one prevented by vaccination suggests you don’t quite appreciate this.

I certainly do. You brought up the topic of public health, and they should be making decisions based on data, not emotion. One of the most important constraints in public health is money. To continually complain about it is baffling.

The only actual argument I can see there is about cost efficacy. You did initially suggest that “people should avoid Gardasil”, and you do now appear to be suggesting that the problem with Gardasil is that too few, not too many, are getting it. Perhaps you would like to clarify your position..

My position has not changed. On an individual basis, one should focus on screening since it is universally recommended. I would not recommend the vaccine because it has no demonstrated efficacy for cancer, and if you have good screening, the vaccine will at best theoretically reduce your risk a couple of percent and only if the regulatory data holds true in real life (which it never does). Public health should stay away since it’s not cost effective and the money better spent elsewhere.

You claimed this is “a pipe dream” i.e. that it is impossible, equivalent to a drug-induced delusion. It is quite clear that Professor Cuzick agrees with me. What do you think he meant by, “That’s the long-term future: vaccination and no screening”?

“Pipe dream” is not incongruent with “not in the foreseeable future” or “wishful thinking”.

I see, so it was just a non sequitur you used as an excuse for plugging Dr Lee’s products.

No, it was an observation based on your reference.

Clearly smallpox and HPV are very different and strategies to eradicate HPV will differ greatly from those that succeeded with smallpox. I don’t see that as a reason not to attempt it, especially when the most likely outcome, even if we fail, is a large reduction in morbidity and mortality.

We already have a very effective way to reduce mortality and morbidity thanks to improved screening. In a way you’re right, relying on a deux ex machina is reason enough not to attempt eradication so we don’t have to bother talking about smallpox.

Those are extremely plausible mechanisms, not wishful thinking.

It’s the quarantine part which requires the wishful thinking as you already acknowledged. Vaccination is only one half of the equation as you well know.

The current vaccine doesn’t cover all cancer-causing strains, but future vaccines will. Testing for HPV is considerably more sensitive than pap screening but it is less specific. Clearly eradication will require an ongoing and responsive strategy as progress against HPV is made.

Neither statement was predicated on future vaccines. Screening is here to stay for the foreseeable future and still he thinks mortality can be eliminated with the technology we have today. That means that screening is expected to be highly effective and we already know it works for all strains.

However, you do appear to have a habit of focusing on unimportant details while missing the bigger picture.

If, treating cost as a key constraint in public health, basing decisions on real evidence of desired endpoints, and making assumptions based on known technology, is considered small thinking, then I guess we’ll just have to leave the big stuff to wishful thinkers like you.

If you were in the US, I’d say enjoy your March break.

Dr Lee doesn’t want the work, he wants it to be done at low cost in the local hospitals instead of leaving it to the big labs where they will charge you a lot more.

Have you ever been to the type of facility to which you refer? I sorely doubt that you’re based in the U.S.

Mr. Pink,

That’s not an actual argument, is it?

It was originally stated in the context of your original assertion and you argued against it in post 525. “Disingenous nonsense (PDF)”.

There is a significant difference between, “There isn’t an ounce of quality evidence showing the vaccine has or will ever reduce the incidence of cervical cancer” (my emphasis) which is what I was arguing against, and “Gardasil has no demonstrated efficacy against the target endpoint. That is a fact because the vaccine has not been around long enough to know if it works against cancer in a real population. All of the studies to date are based on surrogate outcomes.”

I have summarized the issues with your assumptions:
i) You are relying on historically unreliable regulatory studies AND the initial real population data differs significantly

So we can’t believe the studies that show Gardasil is almost 100% effective at preventing HPV-16 and 18 in those not already exposed? Any particular reason why? There is barely any real population data yet – the study you mentioned above looked at 1000 women who were too old to have been given Gardasil at age 12 so we can’t come to any conclusions based on that.

ii) Most CIN2 (which is the only outcome they actually measured) regresses naturally. You don’t know why some small number of cases progress so you can’t assume those cases would have been vaccine preventable.

That’s a strange reverse logic. HPV infection is recognized as the immediate and necessary precursor of all (or almost all) cases of invasive cancer, therefore preventing HPV infection must prevent invasive cancer. The fact that not all HPV infections progress to cancer doesn’t mean that not all cervical cancer started as HPV infection.

iii) Treatment of CIN2 has no bearing on your argument.

So you are arguing that treating CIN2 surgically prevents cervical cancer, but preventing CIN2 occurring in the first place with a vaccine does not? That makes no sense at all. I could paraphrase what you wrote above to, “You don’t know why some small number of cases progress so you can’t assume those cases would have been treatment preventable” which would be equally nonsensical. As I have stated before, if there is some small group of women in whom vaccination is ineffective and in whom HPV is more likely to cause cancer, reducing the prevalence of HPV infection will reduce the chances of them becoming infected, and therefore their chances of getting cancer, through the herd efffect.

Like I said in ii) it’s not a good surrogate.

It’s not a good surrogate for treatment, as you will end up treating too many women whose CIN would not have progressed to cancer, but if you prevent CIN you will prevent cancer.

In post #547, you stated: “Even if the effectiveness of these vaccines was half that found in clinical trials, they would still be well worth using as a means of reducing morbidity and mortality.” My response is an argument against that now proven ridiculous assumption from a public health perspective.

It’s not a “now proven ridiculous assumption” at all. It depends on what economic model you use, what time frame you look at, what assumptions you make and what you set as a threshold for cost effectiveness. This review of cost effectiveness found (ICER is incremental cost-effectiveness ratios and QALY is quality-adjusted life year):

Each model produced a range of cost-effectiveness ratios, dependent on variables included in sensitivity analyses and model assumptions. Sensitivity analyses revealed the lowest ICER to be $997 per QALY gained and the highest ICER to be $12,749,000 per QALY gained. This enormous range highlights the need to clarify what model assumptions are being made.

If Gardasil costs less than $1,000 per QALY my “now proven ridiculous assumption” is definitely true, since even $2,000 per QALY would make Gardasil extraordinarily good value for money. If it costs more than $12 million per QALY, not so much. As I wrote before it’s arguable. In every area of this arena there is a great deal of uncertainty, and very little is definitively proven at all.

However, I can also independently make the argument that Public Health is wasting money on the program and that is the supporting point.

You have made that argument and I, and apparently most of the world’s public health authorities, disagree with you.

Personally I am in the UK so the CDC’s failings don’t matter as much to me as the NHS’s implementation of Gardasil (now replacing Cervarix) which is going very well.

You make the statement but bring no evidence to the table.

It isn’t exactly difficult to find. Here’s some data (PDF) that shows better than 80% average uptake of 3 doses of vaccine in 12-13 year-old girls in 2008/9. More recent data is similar.

Who is at greatest risk in the UK (i.e. those that aren’t taking advantage or getting good screening and followup) and are they getting the vaccine?

Most younger girls are vaccinated in schools, so delivery is very effective. From the link above:

For the routine cohort, 94.2% of 12-13-year-olds were vaccinated in school (see figure 1). For the 17-18-year-old catch-up cohort a more mixed approach was taken by PCTs – 31.4% were vaccinated in the school setting, 60% in GP practices and 8.6% in community clinics and other settings (see figure 2).

Uptake of cervical screening remains high with about 80% of women being screened every 3 or 5 years as appropriate – I won’t link to the data as it will put this into moderation, but I’m sure you can find it easily enough. I agree with you about some poor decisions made by the NHS, but I don’t think that introducing HPV vaccines is one of them.

Yes, you talked about gambles early on. You sound more like a wealth manager selling someone on an IPO of a new company that has no history or background.

I’m excited about HPV vaccines: I think the technology is extraordinary, the efficacy impressive and the safety record remarkable. For the first time ever we have a vaccine that looks very likely indeed to prevent a common cancer. Of course there will be many obstacles to overcome in reducing and ultimately eradicating HPV, but I find your (and others’) negative attitude about such a powerful tool to pursue this goal incomprehensible.

Even worse, your best case scenario is an outcome that is so narrowly positive that there is no contingency. That’s a bad gamble in most books.

My best case scenario is global eradication of HPV, cervical and other related cancers. That’s “narrowly positive”?

Your being the UK lends some insight into why you seem argue for public health decisions without consideration of cost. In the UK you have a heavily funded public programs and people often forget that it’s coming out of your taxes. I won’t even go into the money the NHS wastes.

Since I have spent several decades working for the NHS, and continually trying to do more with ever dwindling annual budgets, as well as paying taxes that pay for it, I am very well aware of how it works. You could argue that value for money is even more important here, as it is public money that will be saved on the treatment of CIN, AIS, cervical and other cancers if the vaccine program is successful. In the US it is mostly individuals and insurance companies who will have to foot the bill, or not.

You brought up the topic of public health, and they should be making decisions based on data, not emotion. One of the most important constraints in public health is money. To continually complain about it is baffling.

You are the one complaining! I’m quite happy with the introduction of Gardasil and the pharmacoeconomic models that decision has been based on. It is you who seems to think that it is better for a woman to be treated for CIN or AIS than it is to prevent her from getting it in the first place.

My position has not changed. On an individual basis, one should focus on screening since it is universally recommended.

There we agree, though that may change when HPV becomes less common.

I would not recommend the vaccine because it has no demonstrated efficacy for cancer, and if you have good screening, the vaccine will at best theoretically reduce your risk a couple of percent and only if the regulatory data holds true in real life (which it never does).

You would seriously advise the parent of a 12-year-old girl (or boy) against her (or him) having Gardasil? You really think that preventing invasive cancer through surgery is just as good as never getting CIN at all? That’s incomprehensible to me, unless you buy into the sort if misinformation SaneVax propagates, and you seem too well informed to swallow that nonsense.

Public health should stay away since it’s not cost effective and the money better spent elsewhere.

“Pipe dream” is not incongruent with “not in the foreseeable future” or “wishful thinking”.

You can play with semantics all you like, Prof. Cuzick still clearly agrees with me, not you.

We already have a very effective way to reduce mortality and morbidity thanks to improved screening.

CIN and AIS count as morbidity, even if successfully treated. Even the most improved screening does not prevent them. Which is better, the vaccine or cervical ablation/excision? If I were a woman I know which I would prefer, even at $120 a shot..

It’s the quarantine part which requires the wishful thinking as you already acknowledged. Vaccination is only one half of the equation as you well know.

If vaccination uptake in 12-year-olds is high enough, we will have a generation in which HPV-16 and 18 will be rare. If polyvalent vaccines are introduced, other strains will also become rare. If antiviral drugs targeting HPV are successful they will become even rarer, and eradication will become a real possibility. As has been noted, because of its mode of transmission you don’t really need quarantine for HPV, just some way of successfully treating it and/or preventing those infected from infecting others. There are lots of ifs there I grant you, but I still maintain it is a good bet that this gamble will pay off.

Screening is here to stay for the foreseeable future and still he thinks mortality can be eliminated with the technology we have today. That means that screening is expected to be highly effective and we already know it works for all strains.

You’re nitpicking, since he stated, “That’s the long-term future: vaccination and no screening” so he clearly doesn’t mean “never” by “the foreseeable future”.

If, treating cost as a key constraint in public health, basing decisions on real evidence of desired endpoints, and making assumptions based on known technology, is considered small thinking, then I guess we’ll just have to leave the big stuff to wishful thinkers like you.

Don’t forget those wishful thinking public health authorities in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, Israel, Ireland, Italy, Kenya, Latvia, Luxembourg, Macedonia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, the United Kingdom and the United States 😉

If you were in the US, I’d say enjoy your March break.

If you are in the US, consider it reciprocated.

Arguing that treatment is preferable to vaccine is heartless, and obviously comes from someone who has never had to experience a colposcopy, or the anguish of waiting years to be pronounced free of HPV displasia and its resulting risk of cervical cancer. The emotional cost is very different when it’s your own body you’re arguing about.

For the record, my son is getting the Gardasil jab when he turns eleven.

Dr Lee doesn’t want the work, he wants it to be done at low cost in the local hospitals instead of leaving it to the big labs where they will charge you a lot more.

Dr Lee doesn’t want the work so much, he is trying to shut competitors out:
http://www.businesswire.com/news/home/20100920005586/en/S.A.N.E.-Vax-Sin-Hang-Lee-MD-Offers
I particularly like the appeal to patriotism as the reason to shut out the competing laboratory : “NCI Pays a Foreign Laboratory for Similar Testing”.

“at low cost in the local hospitals instead of leaving it to the big labs where they will charge you a lot more”

Apparently Milford’s business model involves undercutting the large public hospitals.

@Melissa G “Arguing that treatment is preferable to vaccine is heartless, and obviously comes from someone who has never had to experience a colposcopy…”

You have no clue as to my medical history or that of my family. Arguing for universal experimental vaccination where the treatment holds little discernable benefit for the recipient, obviously comes from someone who has never had a child disabled by a vaccine. For the record, none of my boys will ever get any experimental vaccine.

@Narad “Are you f…ing kidding? This gruel, which has nothing whatever to do with HPV anywhere, is the best you can muster?”

Your density is showing, that slide talks about ROI measurements and includes a lot more than outcomes as Shay asserted. Why would I need a reference for the HPV screening recommendations, when K and I already discussed them at length?

@Krebiozen “So we can’t believe the studies that show Gardasil is almost 100% effective at preventing HPV-16 and 18 in those not already exposed? Any particular reason why?”

Because the efficacy rates in real life are always lower than the rates observed during regulatory trials. Real life and large populations offer up a lot more complicated environments and individuals than controlled studies do. At the most basic level, regulatory studies for this type of pharmaceutical are designed to screen out anyone with any type of known health problem, and that is becoming less and less representative of the general population.

@Krebiozen “My best case scenario is global eradication of HPV, cervical and other related cancers. That’s “narrowly positive”?”

Not with the current vaccine it’s not, which is the context from which you took the quote.

@Krebiozen “You would seriously advise the parent of a 12-year-old girl (or boy) against her (or him) having Gardasil?”

I would never recommend for anyone to participate in a medical experiment let alone a child. Until the outcomes are actually measured, it’s still an experiment. I don’t think there is enough data to confidently get a safety profile. It takes decades for problems with pharmaceuticals to be recognized and action taken to address them.

IMO, attempting to eliminate more and more pathogens through brute force strategies is bound for failure and will cause all sorts of unforeseen side effects. Cervical cancer is clearly caused by more than HPV, and those other factors are undoubtedly involved in other serious diseases. I have no objection to people who want to protect themselves using HPV vaccination if they believe they need it because they live a high risk lifestyle or eat a high risk diet, but there shouldn’t be an expectation for everyone to accommodate or fund what amounts to a big experiment.

@Krebiozen “You could argue that value for money is even more important here, as it is public money that will be saved on the treatment of CIN, AIS, cervical and other cancers if the vaccine program is successful. In the US it is mostly individuals and insurance companies who will have to foot the bill, or not.”

I agree and I believe your system is way more efficient, but the immense waste from several NHS debacles over the past few years is immensely disappointing. Our fundamental differences appear to be based on how we project the available data and how much faith we have in the system. The source of our bias’ are obvious: You work in the system, whereas I work with it from the outside.

I have no objection to people who want to protect themselves using HPV vaccination if they believe they need it because they live a high risk lifestyle or eat a high risk diet

Oh, great, now we’ve gotten to both sexual and food ritual purity.

“Little discernable benefit?”… Yeah, we flat-out disagree.

“Experimental vaccine?” …Yeah, we double-dog-disagree.

“I have no objection to people who want to protect themselves using HPV vaccination if they believe they need it because they live a high risk lifestyle or eat a high risk diet”… So, you think diet has something to do with cancer? Do tell us all about it, please.

Mr. Pink,

I would never recommend for anyone to participate in a medical experiment let alone a child. Until the outcomes are actually measured, it’s still an experiment. I don’t think there is enough data to confidently get a safety profile. It takes decades for problems with pharmaceuticals to be recognized and action taken to address them.

We are all participating in a medical experiment of sorts whether we like it or not. If Gardasil was not approved until its impact on invasive cervical cancer had been proven in RCTs the likely result would be that up to 30,000 women would die unnecessarily, and up to 4 million would require treatment for CIN or AIS that could have been prevented. Once an intervention like Gardasil is available, even opting out is an experiment, an experiment which in this case I think puts the child at far greater risk than opting in.

IMO, attempting to eliminate more and more pathogens through brute force strategies is bound for failure and will cause all sorts of unforeseen side effects.

Most of the inflammatory diseases we suffer from are due to processes that are designed to protect us against pathogens. Once those pathogens are eliminated, by “brute force” or otherwise, we will inevitably see more diseases on the inflammatory end of the scale, such as cardiovascular diseases, autoimmune disorders, allergies and cancer. That doesn’t mean that our brute force strategies cause the inflammatory problems, just that a century ago little Jimmy would have died of pneumonia but today he survives to get asthma and prostate cancer.

Cervical cancer is clearly caused by more than HPV, and those other factors are undoubtedly involved in other serious diseases.

Now I’m bracing myself for Beauchamp or Pasteur’s (bogus) deathbed recantation, “Terrain is everything!” I’m not sure I buy any of the kinds of ideas I think you are hinting at. “Eat, not too much, mostly plants” is about as far as I would go in that direction.

I have no objection to people who want to protect themselves using HPV vaccination if they believe they need it because they live a high risk lifestyle or eat a high risk diet, but there shouldn’t be an expectation for everyone to accommodate or fund what amounts to a big experiment.

One thing I think we should have learned about vaccination is that it is an all or nothing venture. When rubella vaccination was introduced in Greece poor vaccine uptake meant that girls who contracted rubella tended to do so later than before vaccination, resulting in more of them getting it when pregnant and an increase in congenital rubella syndrome. That makes vaccines problematic when it comes to personal freedom, and I don’t have any easy answers. When you consider being infected by a virus turns a person into a walking virus manufacture and distribution system, so I think it is reasonable to expect people to take measures to prevent this. How far we should go in coercing people into vaccination, I’m not sure.

I agree and I believe your system is way more efficient, but the immense waste from several NHS debacles over the past few years is immensely disappointing.

I agree. I have personally felt extremely frustrated by problems in the NHS, such as the hospital I work for purchasing different incompatible computer systems in different departments, a half-assed internal market, and constantly being kept from doing useful work by being expected to attend pointless meetings. I once was asked to attend a meeting and realized when I got there that I hadn’t the faintest idea what it was about, and spent half the meeting quietly trying to figure it out from what was being discussed (it turned out to be about developing a computerized staff record which was a total waste of my time). Large bureaucracies evolve organically over time into unwieldy and inefficient edifices that don’t resemble anything anyone (except perhaps a committee) would design from scratch. The Peter Principle doesn’t help matters – I have often seen a person good at their job get promoted into a management position that they were utterly incompetent at, where they stayed until they could swing early retirement. I could go on, but I won’t.

Our fundamental differences appear to be based on how we project the available data and how much faith we have in the system. The source of our bias’ are obvious: You work in the system, whereas I work with it from the outside.

I do both actually, as a healthcare worker and from time to time as a patient. A couple of times I have felt badly let down by the NHS, which was a very unpleasant experience since I support its principles passionately, and have worked for it for most of my life.

I meant to add that my statement, ” up to 30,000 women would die unnecessarily, and up to 4 million would require treatment for CIN or AIS that could have been prevented” is based on an assumption that it would take 10 years to see if invasive cervical cancer is prevented by Gardasil, and refers to the US alone.

“I would never recommend for anyone to participate in a medical experiment let alone a child.”

And if we all adopt this attitude, then there will never be any medical experiments at all.

[romantic story] Participating in a medical experiment was how I met the Frau Doktorin!
[/ romantic story]

[bladder pride story] Hey, participating in a medical experiment is how I set a record for largest urine sample the PET lab had ever encountered (seriously, this was around 1.3 liters). [/bladder pride story]

In an unrelated development, the fellow behind the absinthe FAQ caused the IRB to take a second look at the experiment (straight fenfluramine), so I was paid for my sessions despite not completing all five.

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