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And now death by Gardasil? Again, not so fast…

I guess this is in effect part two of yesterday’s post. Regular daily readers (and you are a regular daily reader, aren’t you?) will remember that yesterday I commented on the recent uptick in anti-Gardasil vaccine rhetoric coming from the antivaccine crank blog Age of Autism and other sources, in the process deconstructing speculation masquerading as a case report allegedly indicting the quadrivalent HPV vaccine as a potential cause of premature ovarian failure in a 16 year old Australian girl. The article was so bad and so biased that I couldn’t believe BMJ Case Reports published it in the form it did. It’s almost enough to make me take back all those nice things I said about the BMJ in the wake of its publication of Brian Deer’s expose of Andrew Wakefield’s fraud, but in reality the publication of one bad piece of antivaccine propaganda doesn’t invalidate all the good the BMJ did by commissioning Brian Deer to lay the results of his investigation on the line.

You’ll also recall that I noted another article that’s popping up on antivaccine websites. Not content with trying to scare parents and girls with stories of Gardasil robbing young women of their womanhood, antivaccinationists now want to scare parents with stories of Gardasil robbing girls of their lives. So it was that the antivaccine propaganda blog touting an article by the latest scientists to have drunk the pseudoscience Kool Aid that is antivax, Lucija Tomljenovic and Christopher A. Shaw. AoA was joined by the rabidly anti-Gardasil antivaccine group (IN)SANE Vax, Inc., the blog for the antivaccine movie The Greater Good, Gaia Health, and others. That’s no surprise, because we’ve met Dr. Shaw before. He was a key player in that particular bit of propaganda, likening vaccines to part of a toxic soup of chemicals that contributes to autism. We’ve also met Tomljenovic before. Along with Shaw as her co-author, she wrote one of the silliest attempts at blaming vaccines for autism that I’ve seen in a long time (and I’ve seen many, many very silly attempts to blame vaccines for autism over the years). Basically, Tomljenovic and Shaw tried to “prove” that the rising autism prevalence is due to the use of aluminum adjuvants in vaccines and failed utterly, hilariously confusing correlation with causation in a textbook example of how not to draw inferences from statistical data.

Finally, we’ve also met Shaw before when he testified before an investigative committee looking into the death of an 18-year-old woman named Jasmine Renata in New Zealand. Basically, Jasmine’s mother was convinced that her daughter had died because of the HPV vaccine rather than a much more plausible and likely cause, an undiagnosed heart conduction defect. He claimed that he found HPV DNA associated with aluminum in Jasmine’s brain, which would be a real pharmacokinetic and stoichiometric feat if true given the tiny amount of HPV DNA found in the HPV vaccine. It’s such a small amount that it takes a remarkably sensitive (and possibly nonspecific) nested quantitative real time PCR technique promoted by a discredited pathologist named Sin Hang Lee working with (IN)SANE Vax to detect it. So annoyed was Dr. Shaw at my criticism of his testimony that he even briefly showed up in the comments of this post.

All of this brings us to the latest spew by Tomljenovic and Shaw, which was published in a journal I had never heard of, Pharmaceutical Regulatory Affairs, and entitled Death after quadrivalent human papillomavirus (HPV) vaccination: Causal or coincidental? Guess which side Tomljenovic and Shaw want to persuade you to accept as the correct side of this question? (Hint: It ain’t the science-based side.)

Basically, this article consists of two case reports. Case 1 is very clearly Jasmine Renata, whose case I discussed in depth about three months ago. The case description matches almost exactly:

A 19-year-old female without a relevant medical history and taking no drugs expired in her sleep, approximately 6 months after her third and final qHPV vaccine booster and following exacerbation of initial vaccination-related symptoms. She had last been seen alive by her parents the previous evening. Her symptoms started after the first qHPV injection when she developed warts on her hand that persisted throughout the vaccination period. In addition, she suffered from unexplained fatigue, muscle weakness, tachycardia, chest pain, tingling in extremities, irritability, mental confusion and periods of amnesia (memory lapses). The autopsy was unremarkable and failed to determine the exact cause of death. Internal examination revealed some minor changes involving the gallbladder and the uterine cervix (both of which on further examination by microbiological studies and histology revealed no significant disease). After a full autopsy no major abnormality was found anatomically, microbiologically or toxicologically that might have been regarded as a potential cause of death. Histological analysis of the brain hippocampus, cerebellum and watershed cortex allegedly revealed no evidence of neuronal loss or neuroinflammatory changes. However, the autopsy report did not specify which immune antibodies and stains were used for histological investigations.

Case 2 is very almost certainly another cause célèbre in the antivaccine movement, Annabelle Morin of Quebec, who died in 2008 and whose parents are suing Merck for her death after apparently encountered Joe Mercola’s fear mongering about Gardasil online. The clinical history presented sounds very much like Morin’s:

A 14-year-old female with a previous history of migraines and oral contraceptive use developed more severe migraines, speech problems, dizziness, weakness, inability to walk, depressed consciousness, confusion, amnesia and vomiting 14 days after receiving her first qHPV vaccine injection. These symptoms gradually resolved. However, 15 days after her second qHPV vaccine booster she was found unconscious in her bathtub by her mother 30 minutes after she had entered the bathroom to have a shower. Emergency help was summoned and arrived quickly. Resuscitation efforts were attempted. The paramedic noted that the patient was found without a pulse. Upon arrival at the hospital and approximately 30 minutes later, the patient suffered cardiac arrest. Resuscitation was terminated approximately 40 minutes later and the patient was pronounced dead.

Given the resemblance, it must be Annabelle they’re writing about here.

The first thing I noticed here s that Shaw’s story seems to be…evolving. What do I mean? Simple. Go back and look at what he said about Jasmine originally. He claimed that he found HPV DNA in her blood and spleen after her death, saying to the inquest into Jasmine Renata’s death:

He said it was not the result of a natural HPV infection, most likely the DNA was bound to aluminium which was also found in Jasmine.

“The HPV gene is foreign DNA and its detection six months after injection is not normal,’’ he told the inquest.

He said the DNA may cause a reaction that could lead to lethal shock although it was not known if it caused her death but it needed further investigation.

He said it was not known if it was the cause of death but it needed further investigation.

So let’s see. Originally, Shaw was saying that somehow the aluminum adjuvant in the HPV vaccine somehow complexed with HPV DNA from the vaccine in order to work its evil effects. He said this even though, as I explained above, the amount of HPV DNA in a dose of Gardasil is so small that it takes ridiculously sensitive PCR techniques to detect it, and, even then, I’m not entirely convinced that what Lee found really was HPV DNA and not a contaminant. We’re probably talking nanogram, if not picogram, quantities of DNA. It defies basic chemistry and plausibility to propose that such a minuscule amount of DNA not packaged in a virus or other delivery vector could cause such a reaction. It makes one wonder, it does. Did Shaw realize that his original story didn’t pass the smell test? Did he realize that molecular biologists were rolling in the floor with laughter or snorting at him with contempt over this explanation? Did he actually take my post to heart? Think of it. His manuscript is listed as having originally been submitted on September 13, 2012 and accepted for publication on October 2, with a publication date of October 4. While noting that that’s a mighty fast turnaround time (which makes me wonder about the quality of the peer review for this journal), I also note that it’s also over a month after my post. Sure, I could have an overinflated sense of my own importance. It wouldn’t be the first time I’ve been accused of that. But, still, I wonder.

Whatever the reasons, Tomljenovic and Shaw are now claiming something somewhat different but only marginally more plausible. I’m not a neuroscientist, nor am I a pathologist, but one thing I can’t help but note is that neither Tomljenovic and Shaw are pathologists, either. In particular, neither of them are neuropathologists. If there’s one thing I know about neuropathology, it’s that it’s tricky. It’s not trivial to get antibodies to work properly on brain tissue, nor is it a trivial matter to interpret. None of this seems to have induced our not-so-dynamic duo to have recruited a neuropathologist to assist them with interpretation of the immunohistochemical stains of the brain sections. Were I a reviewer for this paper, I would have recommended not publishing it without a neuropathologist as an author. None of this keeps the authors from boldly proclaiming that neuroinflammation caused by the HPV-16L1 antigen is strongly implicated as the cause of these girls’ deaths through an autoimmune vasculitis due to the deposition of HPV-16L1

Not so fast, there pardner.

The first thing to consider is the biological plausibility of the HPV-16L1 protein somehow depositing in the brain vasculature in order to be able to cause an immune reaction. Each dose of Gardasil contains approximately 20 μg HPV-16L1 protein, which is injected locally intramuscularly. While this is clearly not difficult to detect the way the trace DNA left over in Gardasil is, it’s still by no means a lot of protein. Yet, according to our not-so-dynamic duo, this tiny amount of protein caused this:

In both cases, the autopsy revealed no anatomical, microbiological nor toxicological findings that might have explained the death of the individuals. In contrast, our IHC analysis showed evidence of an autoimmune vasculitis potentially triggered by the cross-reactive HPV-16L1 antibodies binding to the wall of cerebral blood vessels in all examined brain samples. We also detected the presence of HPV-16L1 particles within the cerebral vasculature with some HPV-16L1 particles adhering to the blood vessel walls. HPV-18L1 antibodies did not bind to cerebral blood vessels nor any other neural tissues. IHC also showed increased T-cell signalling and marked activation of the classical antibody-dependent complement pathway in cerebral vascular tissues from both cases. This pattern of complement activation in the absence of an active brain infection indicates an abnormal triggering of the immune response in which the immune attack is directed towards self-tissue.

Here’s the thing. The autopsy didn’t show any abnormalities in Jasmine’s brain that could account for her death. The same was true of Annabelle. If these girls had an immune-based vasculitis, it should have been visible as severe inflammation in the brain tissues on normal H&E sections (sections stained with the usual blue and pink dye and no special immunohistochemical stains). Then, the IHC would reveal the potential cause. For instance, in Case 1, Tomljenovic and Shaw note that the pathologist found no signs of neuronal loss or neuroinflammatory changes but that it wasn’t reported which antibodies were used. More than likely the answer is none; routine sections would just be H&E, with IHC reserved for cases in which an abnormality was noted on H&E. In Case 2, Tomljenovic and Shaw bemoaned how the pathologist didn’t use any specific antibodies for inflammatory markers but rather noted changes consistent with terminal ischemic-hypoxic encephalopathy. What that means is that the pathologist thought that the changes he observed were consistent with the brain’s having suffered a significant period of time with low blood flow, rendering it ischemic, something that could have happened if the girl had a very low blood pressure for a while before she died.

So what we have is a non-pathologist, who clearly doesn’t know how to interpret common pathological findings, throwing every inflammation-related antibody in the book at the brain section and then concluding that there is some sort of neuroinflammation because he sees staining in the blood vessels in the brain. There’s one huge problem, though, and Tomljenovic and Shaw basically admit it:

The obvious limitations of our study are that the tissues examined represent two individuals against which there were no control samples. For this reason, we could not obtain a quantitative measure of immunoreactivity. We aim in the future to further corroborate our findings by examining brain tissues from other cases of sudden and unexplained death following HPV vaccination, as well as control brain tissue from age-matched individuals who clearly died from nonvaccination related causes. Nonetheless, the marked resemblance in immunostaining patterns for all immunohistological markers in brain tissue specimens in the present two cases (i.e., compare Figures 1-4), as well as the similarity between their symptoms and those noted on VAERS reports related to post-HPV vaccination vasculopathies (some of which were medically ascertained cases; Tables 2 and 3), strongly support our present conclusions.

Uh, no they don’t. Tomljenovic and Shaw’s findings could just as well be nonspecific immunostaining. Not only didn’t they examine sections of age-matched normal brains as controls (the very minimum they could have done), but, as far as I can tell from this paper, they neglected to do some very basic controls for any IHC experiment. Specifically, I don’t see any reference to a “no primary antibody” control or an isotype control. In the absence of such controls, there is no compelling evidence that the staining that Tomljenovic and Shaw are reporting is anything other than due to nonspecific interactions between the antibody and cellular structures. This is a lot more common than one might think. Many are the physicians and scientists who have tried to do IHC for a research project and found that it’s nowhere near as cookbook as the antibody and reagent manufacturers would like you to think from their protocols. It’s one reason why IHC is often referred to as an art as much as a science. it often takes a lot of trial and error to get it right, even with commercial antibodies with seemingly well-defined protocols from the manufacturer.

Another thing they could have done to convince skeptics like me is something called an adsorption control Basically, that means incubating the primary antibody with the antigen it’s supposed to detect. If the interaction being observed is specific, then adsorbing it this way should eliminate the staining, because the specific antibody will complex with the antigen. Finally, there should be a positive control. For HPV proteins, this would mean perhaps cervical cancer lesions known to be due to HPV infection. I will admit that a lot of investigators don’t report all of these controls, but they usually report at least a couple of them, usually the isotype control and the no primary antibody control. In particular, for a novel or unusual finding (such as the finding of HPV-16L1 in the neurovasculature), more controls need to be done. Also, reviewers will give a skilled pathologist a bit more of the benefit of the doubt if he doesn’t present all controls, because, well, he’s a pathologist and does this sort of thing every day for a living in real patient samples. Tomljenovic and Shaw don’t rate that sort of benefit of the doubt. They should show their work, but do not. If I had to guess, what we’re seing in their IHC sections is nonspecific staining.

That having been said, I’m not a pathologist, either, although I’ve done a fair amount of IHC in my laboratory. The difference, of course, is that I’m not diagnosing patients. In any case, as Dirty Harry once said, “A man’s got to know his limitations.” I know mine. I know that I could be wrong. So I’d love it if any of my readers are pathologists, particularly neuropathologists, could comment. In particular, the choice of antibodies by Tomljenovic and Shaw seems to include antibodies that are mainly used for research and not routinely used in clinical specimens for actual diagnosis, which means even more that, even if what we’re seeing is not nonspecific, its significance is unclear. Still, given the tiny amount of HPV-16L1 in each Gardasil dose, I’d bet that the finding of this protein in the neurovasculature of these girls is almost certainly nonspecific staining.

Basically, Tomljenovic and Shaw have become the latest not-so-dynamic antivaccine duo trying to lend scientific credibility to quack antivaccine views. They’ve clearly been co-opted by the antivaccine movement and have become true believers, so much so that Shaw is in danger of throwing away whatever scientific credibility Shaw once had. I hope they like their new friends. If they continue on this path, they’ll soon be replacing their scientific colleagues for a bunch of cranks, just the way Andrew Wakefield, Mark and David Geier, and Dr. Sing Han Lee have. Soon all they’ll be good for is giving aid and comfort to antivaccine cranks by churning out crap studies that can be cited over and over and over again by antivaccinationists. Oh, joy.

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]

222 replies on “And now death by Gardasil? Again, not so fast…”

Groan. Number 1) Always use a control and look at it first before you look at the section. Number 2) Background staining anyone?

Orac, you keep referring to this pair and others as ‘not so dynamic’ duos. While clearly true, the bar for ‘dynamic’ at AoA, GR and other sites and venues is so low that breathing is barely all that’s required. Mouth breathing of course.

Boys are getting the HPV shot now, aren’t they? So where are the reports of boys falling mysteriously ill and dying after getting the vaccine?
Clearly, us girls are so much weaker and frailer than the big, tough boys….

@sophia,
The push to have boys get the HPV vaccine is relatively recent and the uptake has been slow so far I think. But you wait for the future headline:, “Boy Falls from Tree – Gardasil to Blame”.

It doesn’t have to make sense or follow any scientific reasoning, just spread fear.

a journal I had never heard of, Pharmaceutical Regulatory Affairs

The first issue of the latest pay-to-print addition to the portfolio of a notorious zero-standards Open Access scam? Your ignorance is forgivable.

I am a pathologist. I don’t know any respectable pathologists who would throw antibodies at normal-looking tissue. That’s just asking for trouble. I could not provide specific comments about these cases without reviewing all the slides, including positive and negative controls, if they indeed exist. If this group did do these stains on normal-appearing tissue as it seems, I would tend to regard the results as spurious without a great deal of additional data, including large numbers of patients with a similar history.

I would add, however, that in clinical practice, nobody does adsorption controls, but we are working mostly in relatively familiar situations in which we know what to expect, and we can recognize most of the artifacts. An adsorption control might be useful in a setting like this, and, I would expect it to show that the staining that they reported is non-specific.

HDB has the right of it; there’s a slew of open access crap journals popping up lately – who claim to have peer review, but I think that just means “I opened the .pdf and saw words there”.

T. Bruce (a pathologist) commented on the pseudo-findings of cerebral vasculitis in another thread and I (also a pathologist, who works with immunohistochemistry on a daily basis) agreed with him that the conclusions of the paper’s authors about the brain histopathology were bunk, in particular the following:.

“our IHC analysis showed evidence of an autoimmune vasculitis”

No, it did not. The diagnosis of vasculitis requires at a minimum evidence of destructive inflammation involving blood vessel walls. From one of my pathology texts: “Vasculitis…is used to describe vessel injury manifested by varying degrees of endothelial degeneration and necrosis.” Mostly when this process is suspected clinically we get skin biopsies aimed at confirming it, and it can be tricky to make the diagnosis. Seeing inflammatory cells involving the vasculature is not enough; you need evidence of blood vessel damage. These people couldn’t even cite the presence of inflammatory cells, therefore their “evidence of an autoimmune vasculitis” is nonexistent.

If it’s true that they didn’t use proper positive and negative controls on their IHC stains, even those are worthless. I just had a tumor case with a clear pattern of staining, but I did not release the results until I had repeated the test twice more to get the negative control working properly.

This paper should not even have been accepted in the Journal of Irreproducible Results.

“Histological analysis of the brain hippocampus, cerebellum and watershed cortex allegedly revealed no evidence of neuronal loss or neuroinflammatory changes. ”

Wait so are they accusing the person administering the autopsy of being incompetent or corrupt?

I suspect there will never be quite the same degree of anti-vax outrage over HPV vaccine for boys as there is for girls.

I’m often amazed at how quickly this blog can bring in heavy artillery, this time in the form of Dr. Finfer and Dr. D. Bacon. Thanks for sharing your expertise!

I would add, however, that in clinical practice, nobody does adsorption controls, but we are working mostly in relatively familiar situations in which we know what to expect, and we can recognize most of the artifacts. An adsorption control might be useful in a setting like this, and, I would expect it to show that the staining that they reported is non-specific.

Of course, I didn’t mean that they necessarily should have done this for all the antibodies. They should, however, done it for the antibody against HPV-16L1, given that finding staining for this protein in the cerebral vasculature was a very unusual and implausible finding that almost certainly represented nonspecific staining. In any case, this is not normal clinical practice. It’s a research paper proposing a very controversial and biochemically implausible finding. Not doing such controls calls Tomljenovic and Shaw’s work into question right away. I also know that many papers publishing IHC results don’t actually show their isotype and no primary antibody controls, but they usually at least mention in the methods that their controls worked properly.

From a technical standpoint, it’s particularly interesting (read suspicious) that nearly all of the positive tissue staining they report is in the endothelial cells of the brain. In the world of immunohistochemistry, it’s well known that endothelial cells always exhibit a high degree of non-specific background staining (due to high levels of nitric oxide production). One way to address this is with a quenching step using hydrogen peroxide (which the authors report doing in the methods), but I can tell you from personal experience that this rarely gets rid of the problem…which is precisely why you MUST show the appropriate controls (no primary antibody control and substrate only control).

No, it did not. The diagnosis of vasculitis requires at a minimum evidence of destructive inflammation involving blood vessel walls. From one of my pathology texts: “Vasculitis…is used to describe vessel injury manifested by varying degrees of endothelial degeneration and necrosis.” Mostly when this process is suspected clinically we get skin biopsies aimed at confirming it, and it can be tricky to make the diagnosis. Seeing inflammatory cells involving the vasculature is not enough; you need evidence of blood vessel damage. These people couldn’t even cite the presence of inflammatory cells, therefore their “evidence of an autoimmune vasculitis” is nonexistent.

Even though I’m not a pathologist, that’s what I thought too. Vasculitis is a histological finding that should be easily visible on routine H&E sections if it’s significant enough to cause or contribute to the death of otherwise healthy young women. No histological findings of vasculitis = no clinically significant vasculitis. The lack of finding immune cells such as neutrophils is particularly telling, as it’s hard to have real inflammation without finding inflammatory immune cells in the specimen. Or at least that’s what I thought, and our pathology colleagues seem to be confirming this observation. In other words, if there are no abnormalities on routine H&E sections, there is no reason to do all these special stains that Tomljenovic and Shaw did that a pathologist would find convincing. In reality, the reason that Tomljenovic and Shaw did all these stains appears to be because they thought there was an autoimmune vasculitis (even though qualified pathologists didn’t see evidence of it), thought that this nonexistent autoimmune vasculitis must be due to cross reactivity between antibodies against HPV-16L raised by vaccination with HPV vaccine, and sought to find IHC staining that they could shoehorn into their dubious hypothesis.

From a technical standpoint, it’s particularly interesting (read suspicious) that nearly all of the positive tissue staining they report is in the endothelial cells of the brain.

I wondered about this too. If there was that much inflammation, the inflammatory changes and the antigens against which Tomljenovic and Shaw stained should show up in more than just the cerebral endothelium. That raised a red flag for me, too. Perhaps I should have mentioned it in my post more prominently. I’ve also done some staining against endothelial cells in my lab and have seen first hand how often they exhibit nonspecific staining that can sometimes fool even experienced technicians.

Just a humble physician, with no pretensions to pathology, but from what I know I too would expect to see systemic changes outside the CNS.

For me the clincher is that the clinical presentation is categorically not one of cerebral vasculitis. You don’t see someone walk into the shower only to be found dead 30 minutes later, and conclude the COD was “cerebral vasculitis”. Even the most hyperacute clinical presentation would see someone developing confusion and neurological symptoms progressing to coma and death over days (not minutes). Typically vasculitis is associated with a subacute , intermittently progressive presentation with neurological features developing over several weeks.

In addition, cerebral vasculitis severe enough to cause death should be accompanied by quite florid pathology, visible at the naked-eye macroscopic level and typified by huge great wodges of fibrinoid necrosis with occlusion and infarction of multiple affected vessels.

Why does this report remind me of the type of paper produced by Mohammed Al-Bayati (he of Eliza-Jane Scovill and Christine Maggiore “they did not die of AIDS but drug reactions” fame?). Because it is the same process – start with a concept and twist the facts (or invent some) to confirm your predetermined diagnosis.

No controls, no plausible mechanism, no replication of the research that supposedly supports their shaggy dog story of a hypothesis, and conclusions that are wildly inconsistent with the autopsy findings. Execrable, and the amount of damage it will cause is inestimable. A quick Google search shows it has spread like wildfire across the net, presented as incontrovertible evidence that Gardasil kills.

I think this paper is far more dangerous than Gardasil: some people will be dissuaded from getting vaccinated against HPV because of it, and some will contract HPV and either get cancer and die, or spread HPV to others who will die as a result.

I’m late to the party, but I just want to add my agreement with my fellow pathologists about the total lack of histologic evidence of vasculitis, and the incompetent use and interpretation of the immunostains. As a graduate of UBC, I find this to be extremely painful.
BTW, Shaw has already gotten the “brave anti-establishment rebel with a breakthrough” treatment from the Vancouver throwaway press.

If not acceptable to even the Journal of Irreproducibe Results, how about the Journal of Dangerous Nonsense?
Yes, this blog beings in the heavy artillery which I also appreciate. These are busy people who deal with real medical problems. It’s a shame that this sort of talent has to be brought to bear on shysters who will simply turn around and make up other nonsense and delude unhappy people. So far as boys getting the HPV vaccine, it’s just a matter of time before other crazy allegations emerge around ill or dead young men.

OT- but is stooping low by alt media ever TRULY OT @ RI?
I ask you sincerely.

In the wake of a devastating hurricane that has impacted tens of millions of people, causing death and destruction:
Anne Dachel writes about ‘hurricane autisim’
and, never to be outdone, Mike Adams ( Natural News) has over the past few days offered his ideas about ‘preparedness’, including how to behave when the looters come.

There you go, Orac. Twenty comments and three are from pathologists…in sharp contrast to the many blogs on the anti-vaccine websites about Gardisil *deaths*, which have zero comments from pathologists.

“We’re probably talking nanogram, if not picogram, quantities of DNA”

That’s almost a homeopathic amount of DNA. Wouldn’t that make it beneficial according to homeopathic principles? 🙂

Hard to believe it could be even nanogram amounts of DNA. If any, could be sub-pg. My guess. Nanogram amounts would be very easily detected. My guess, too, there are specs on DNA content in that vaccine. Homeopathic most likely.

Has anyone located the lawsuit, in French or English, regarding the death of Annabelle Morin *associated with Gardasil vaccine*?

The lawsuit should list her mother Linda Morin as a plaintiff suing Merck Frosst Canada & Company.

@Karl

That’s almost a homeopathic amount of DNA. Wouldn’t that make it beneficial according to homeopathic principles?

No, no. You’re forgetting one of the most important parts. It must be succussed. Succussion is essential. You gotta’ bang that stuff with a horsehair filled paddle. Or something. See, we sciency types never can get anything right. Sheesh!

Even the students in my undergrad classes can get that simple, first lesson of labwork: if there aren’t both positive and negative controls then it isn’t an experiment. Shaw is notorious for and persistent in ignoring necessary controls. He asserts that there’s aluminum based on Morin staining but doesn’t do the controls to rule out crossreaction with iron, he measures small behavioral changes but doesn’t blind the evaluator to which treatment group the mice are in, he routinely does IHC with non-specific/non-standard/non-validated stains and has not once done appropriate positive and negative controls nor does he score intensity but simply reports presence. I’d fail a first year premed student for that kind of research ethic.

@dandover,

You can’t prove that it wasn’t successed! Therefore by the rules of woo-logic and argument, I can claim that is was successed.

David, in the interests of objectivity, when you say, “He claimed that he found HPV DNA in her blood and spleen after her death, saying to the inquest into Jasmine Renata’s death:

He said it was not the result of a natural HPV infection, most likely the DNA was bound to aluminium which was also found in Jasmine.

“The HPV gene is foreign DNA and its detection six months after injection is not normal,’’ he told the inquest.

He said the DNA may cause a reaction that could lead to lethal shock although it was not known if it caused her death but it needed further investigation.

He said it was not known if it was the cause of death but it needed further investigation.”

Don’t you mean, “reported as saying…”?

A quick Google search shows it has spread like wildfire across the net, presented as incontrovertible evidence that Gardasil kills.

More accurately, I think, it was spread. This isn’t a case of anti-vax bloggers idly reading one another’s blogs, encountering the paper, and thinking “That’s worth repeating”. Someone at SaneVax will have e-mailed it to everyone on the mailing list, to ensure that the shouting is synchronised.

You don’t see someone walk into the shower only to be found dead 30 minutes later, and conclude the COD was “cerebral vasculitis”.

The summary of the pathology report for Case 2 mentions cerebellar herniation, i.e. the girl’s brain had suddenly swollen to the extent that the pressure was pushing it cerebellum-first down through the foramen magnum. Whatever happened to her, it sounds acute.

there’s a slew of open access crap journals popping up lately – who claim to have peer review, but I think that just means “I opened the .pdf and saw words there”.

Some disrespectful derision of the OMICS-journal scam here (already blogpimped on a previous thread, whence it attracted a gratifying number of visitors of RI-readers, but I’m going to advertise it again).

Don’t you mean, “reported as saying…”?

You’re not supposed to bring cane toads into New Zealand, Ron.

Oh, Ron Law, your inability to understand dose relationships is as bad as Shaws… Yes, naked DNA can cause shock due to triggering Toll Like Receptor 9. The amount needed depends on the route of administration, with responses far more severe to iv dosing than im or ip. To generate shock with an iv dose of unmethylated naked bacterial DNA you need at least 400 micrograms for a mouse with a 20 gram body weight. If you scale that up to human size, even though we are less responsive to TLR9 shock and yeast DNA (from producing HPV vaccine) is much less potent than bacterial DNA, that’s 1.8 grams of DNA that’s required. 1.8 grams! That’s over 200 million times the amount of DNA a regular cheap PCR reaction can detect – and those always come up negative when used to detect DNA in Gardasil preps.

Yeah, sure, the inactive, fragmented, yeast-based DNA with the wrong codon bias that can’t be translated to protein in human cells that’s far less than 1/200 millionth of the amount required to cause shock is doing something. Sure.

And, for the record, binding DNA to aluminum makes it degrade faster. That’s been known since 1971. Dimwits.

We’re probably talking nanogram, if not picogram, quantities of DNA.

Ah, but this is DNA bound to aluminium hydroxide particles, in a way that preserves it from degradation within the body — even after six months, and even during digestion of the particles by phagocytes — while enhancing its properties as an antigen. Once inside a phagocyte, the AlO / DNA complex takes over the cell and causes it to migrate through the lymphatic system up into the brain, overcoming the blood/brain barrier and allowing the aluminium to concentrate there.

That was the original story, anyway. I can see why the authors have abandoned it in preference for the straight toxic-protein-in-the-vaccine account.

Of course there is now the problem that the amount of HPV-16L1 in an injection is NOTHING compared to the amount of the stuff mass-produced by a wart (being a building-block of the HPV capsid), yet warts are not killing people by neuroinflammation.

Don’t you mean, “reported as saying…”?

Ah, pedantry! One wonders what Ron’s point is, one does. It couldn’t be to try to imply that somehow Dr. Shaw was misquoted when he referred to HPV DNA, could it?

Of course there is now the problem that the amount of HPV-16L1 in an injection is NOTHING compared to the amount of the stuff mass-produced by a wart (being a building-block of the HPV capsid), yet warts are not killing people by neuroinflammation.

Excellent point that I should have mentioned…

Jay Chaplin, mees thinks you’ve got me mixed up with someone else… I haven’t made any comments to warrant such an outburst…

David, my point is that when one takes the accuracy/science hi-ground one needs to be accurate. Having read the transcripts of what was actually said I am only to aware that what was reported does not often align with what was said… unless you are saying that relying on anecdote is ok… in which case you are into woo country.

And, for the record, binding DNA to aluminum makes it degrade faster. That’s been known since 1971.

Jay, could you point me towards a reference for that? Thanks.

HDB… “Ah, but this is DNA bound to aluminium hydroxide particles…”

I wasn’t aware aluminium hydroxide was in gardasil… as for so-called amorphous aluminum hydroxyphosphate sulfate, what exactly is it? It’s certainly not a chemical in any science text book with a chemical formula. I note even Merck refer to it as “Merck aluminum adjuvant. MAA is an
amorphous aluminum hydroxyphosphate sulfate adjuvant.
The term “MAA” is used interchangeably herein with the
tenn “AAHS.””

I have yet to find an expert who can tell me what it actually is and there is no chemical formula for it… that being the case it seems to me that it is a novel compound that has not been formally approved.

It certainly isn’t aluminium hydroxide as you’ve said… nor aluminium phosphate as New Zealand’s so-called expert at IMAC (Helen Petousis-Harris) told me.

HP-H’s email said, “Amorphous aluminium hydroxyphosphate and aluminium hydroxyphosphate sulfate are still commonly referred to as aluminium phosphate. From what I can gather there have been changes to terminology over the past 20 years as studies have explored the structure of adjuvants and re-characterised them based on morphology. Historically, aluminium adjuvants have been often referred to as either aluminium phosphate or aluminium hydroxide depending on the level of phosphate present. Precipitation in a buffered solution involves anions and amorphous adjuvant and is dependent on the precipitating conditions and in turn dependent on the desired isoelectric point which is antigen dependent.

The chemical formula of aluminium phosphate vaccine adjuvant is Al(PO)4

Aluminium phosphate is aluminium hydroxide in which some hydroxyls have been substituted for phosphate. This is what gives amorphous aluminium hydroxyphosphate Al(OH)x(PO4)y. The degree of phosphate substitution depends on the reactants and method of preparation. If the starting source of aluminium is potassium aluminium sulphate and when there are phosphate anions present during the precipitation process then amorphous aluminium hydroxysulfate will become amorphous aluminium hydroxyphosphate sulfate, as some of the phosphate anions substitute some of the hydroxyls.
There is no fixed ratio of hydroxyl to phosphate (not stoichiometric).”

What a hoot… “The chemical formula of aluminium phosphate vaccine adjuvant is Al(PO)4”

Al(PO)4 must be another non-approved novel ingredient used in vaccines.

Ron,

I haven’t made any comments to warrant such an outburst…

A brief perusal of your performance here is quite sufficient to refute that.

Orac,

Regards warts: it’s one of the elements that have been bothering me – Jasmine Renata had repeated treatment for warts.

David, my point is that when one takes the accuracy/science hi-ground one needs to be accurate. Having read the transcripts of what was actually said I am only to aware that what was reported does not often align with what was said… unless you are saying that relying on anecdote is ok… in which case you are into woo country.

In other words, you’re concern trolling and have no real point to make worth paying attention to. Thanks for clearing that up.

It certainly isn’t aluminium hydroxide as you’ve said

Please notice that Dr Shaw’s theories are the subject here, not the real world. And Dr Shaw did specify “aluminium hydroxide”, over and over, back when he was promoting the aluminium adjuvant as the reason why vaccines were EVUL.

He has now abandoned all his previous clinical observations in favour of a new theory about proteins, keeping only the conclusions.

Dr Sin Hang Lee claims that the magic inert / active DNA is bound to aluminium hydroxyphosphate sulfate, and the specs for Gardasil say “amorphous aluminium hydroxyphosphate sulfate”.

as for so-called amorphous aluminum hydroxyphosphate sulfate, what exactly is it? It’s certainly not a chemical in any science text book with a chemical formula.

F*cking glass, how does it work?

Ron, you are a clucking whoron. You are describing the aluminum hydroxyphosphate gel in first year chemistry terms. Real life isn’t like that. There is no such thing as Al(PO)4 as aluminum phosphate absorbs moisture form the air and proceeds to a mixed hydroxide/phosphate gel not unlike that formed intentionally by Merck. Even if you could keep such a thing dry in the lab under a dessicator it would be Al2(PO4)3 you twit, you have balanced neither the charges nor the atoms. You are here to parrot concerns you understand nothing about yet you pretend to be able to understand experts and speak of taking the scientific high ground – you deserve nothing more than scorn.

Ron,
I have read your last comment about AAHS several times, and it still makes no sense. It’s clear what AAHS is, though the precise proportion of hydroxide to phosphate to sulfate is a proprietary secret. Maybe this will help:

Merck Aluminum Adjuvant (AAHS) is a proprietary aluminum hydroxyphosphate sulfate formulation that is both physically and functionally distinct from traditional aluminum phosphate and aluminum hydroxide adjuvants. At a macromolecular level, AAHS is structurally related to aluminum phosphate as it forms an amorphous mesh‑like structure. AAHS bears a nearly zero charge at neutral pH (Caulfield et al., 2007).

Caulfield et al. add:

Amorphous aluminum hydroxyphosphate sulfate adjuvant (AAHS) […] is prepared by precipitation of alum with sodium hydroxide.
So we know its chemical makeup (within limits as it is a proprietary formula), its structure, its electrochemical characteristics, how it compares to other aluminum adjuvants and how it is prepared. Caulfield even has an electron micrograph of it compared with AlOH and AlPO. Vaccines containing AAHS have gone through, and have passed, stringent safety studies. What else do we need to know?

I can understand that RLaw is seizing the opportunity to make scary noises (theremin music playing in the background) about the unknown, untested properties of anything related to Merck and vaccines.

Let us also keep one eye on the original topic, i.e. the shifting nature of Dr Shaw’s position —

(1) Aluminium hydroxide causes encephalopathy in mice, therefore vaccines = evil.
(2) Tests reveal HPV DNA in brain samples, transported there by DNA binding to aluminium-hydroxide nanoparticles which are swallowed by phagocytes — subsequently migrating to the brain because that’s what possessed phagocytes do — therefore vaccines = evil.
(3) Tests now reveal HPV proteins in brain samples, therefore vaccines = evil.

HDB,
I find it hard to resist pointing out that even Ron’s attempted distractions fail when subjected to the slightest scrutiny.

Clear evidence that AlPO is perfectly safe: people have been feeding it to their dogs for years!

Richard Smith, didn’t you call yourself Blackheart last time you came trolling here?

Krebozian, I believe that Richard Smith also poses as “ASD Researcher” since that implies some sort of credibility.

Oboy, that went so completely over my head.

Now if only I had time to go away and learn all the terminology.

Long ago, and anecdotally, I had multiple Pap tests leading to a diagnosis of CIN III. I had a laser conization. This was back when doctors didn’t tell patients much, if anything. I got very good at “assuming the position” for 1/month the first year, 1/3 months the 2nd year thereafter, 1/6 months the next 3 years thereafter, then once annually. Everything’s ok now, and I had a chat with my doctor about Thin Prep when it first came out. She agreed. I personally would recommend both boys and girls get Gardasil – boys spread HPV without knowing, girls don’t know they have HPV unless they can get Pap tests (which many dislike or can’t afford)

(Argh, phone submitted comment before I finished) …and both can get cancer from HPV. There is a small amount of risk – as with anything else in life – but getting vaccinated far outweighs the potential of getting cancer, IMO.

I suspect that sexist thinking that sexually active boys are “sewing their wild oats” and sexually active girls are “sluts” fuels the fevered furor of the anti-vaxx crowd. HPV doesn’t (chemically) ask “are you a slut?” It only asks “are you human?”

@Ron Law

Any chance you can give us a date for when you’ll release your super secret documents that prove vaccines are bad?

@ brian:

John Richard Smith a.k.a. Blackheart a.k.a. ASD Researcher finally *gave it up* here…

http://lacrossetribune.com/news/opinion/michael-winfrey-former-doctor-was-not-invited-to-uw-l/article_77a7ee6a-13ea-11e2-9389-001a4bcf887a.html

@ Pareidolius: Where have you been? We’ve missed you!

Update on Sandy: My daughter’s childhood chum finally checked in. She lost her home on one of the barrier islands and she is back on the mainland with her young son. They stopped by “trick-or-treating”.

I doubt the any real test showed any such thing as HPV DNA in the brain or any other organ. Seems to be a lot of hand-waving and unwarranted assertions regarding fanciful mechanisms around aluminum. It’s certainly possible to run “ultrasensitive” PCR until you get a shaky result that is proclaimed to be positive by “experts” with conflicts of interest and uncertain intent. There is ample precedent in forensics. Consider Amanda Knox & R.S. in Italy last year. The “evidence” submitted by the prosecution was in fact nonexistent – utterly discredited. The press didn’t get it, suggested that it was “not clear”. Same thing likely with these bogus brain. blood.spleen results – my assertion without seeing the lab notebooks & data. Again, what is the established spec for DNA content (from any source) in the HPV vaccine? HPV DNA at some level might well be nearly ubiquitous where there lots of people. Or where there are labs using it to develop & standardize their tests. More likely that than implausible physiology.

In effect, this Tomljenovic-Shaw paper is a complete retraction of Shaw’s testimony to the NZ inquest into Ms Renata’s death (i.e. the DNA / aluminium theory is no longer operative). Has anyone else notified the coroner? He might want to invite Dr Shaw for another telephone session to update his testimony.

THS,

Again, what is the established spec for DNA content (from any source) in the HPV vaccine?

Good point. The anti-Gardasil crew spin it as if vaccines and everything else should be squeakily clean of scary non-human DNA. In fact we are not only swimming in a sea of foreign DNA, it is inside us, inside our cells, in our food, everywhere. As I understand it the difficulty with PCR isn’t so much detecting DNA as avoiding contamination, and being sure you have actually detected what you are looking for.

Food from plants and animals that we and our ancestors have been eating for billions of years is loaded with non-human DNA, so we must have evolved some very effective defenses against it. It would be simply astonishing if a tiny fragment of non-human DNA could somehow hitch a ride into someone’s brain inside phagocytes and wreak havoc. No wonder T & S have abandoned their DNA hypothesis in favor of their marginally less implausible HPV protein scenario.

That reminds me, a recent BBC documentary about the viral infection of a cell is worth catching if you get the opportunity. It shows just how sophisticated a virus’s infection mechanisms have to be to get its DNA inside the cell, inside the nucleus and for it to then have any effect. It’s voiced by David Tennant and has some of the most amazing CGI I have ever seen. I’m sure it will be shown on PBS in the US at some point if it hasn’t already.

By the way, it isn’t normal to find phagocytes in the brain, as I known from examining CSF which is normally crystal clear. The slightest hint of cloudiness indicates the presence of white blood cells which suggests infection. T & S seem to be suggesting that Gardasil routinely causes some sort of brain infection that allows phagocytes, carrying their deadly cargo of HPV proteins attached to aluminum adjuvant particles, into the brain.

This is a testable hypothesis, though I don’t think a study that involves doing lumbar punctures on young women who have been administered Gardasil compared with vaccine-free controls would or should get past an IRB. There must be less invasive ways of testing this that might put an end to this speculation.

Krebiozen,

Long story, short, nested PCR requires good quality control. (I would say more, but let’s not be boring…!)

K: “There must be less invasive ways of testing this that might put an end to this speculation.”

While there are bound to be things researchers might do, I’m a bit leery of his being “obliged” to check out “concerns” that have little merit – it’ll generally be an enormous waste of research dollars and time. (Public health types might argue that ending the speculation has value – true, but can’t cheaper and more general means, like education, address this?) We’ve already see this for, say, vaccines-cause-autism and more recently XMRV-causes-CFS. That last, at least, had some science (even if botched) triggering it, but it’s clear the latter paper at least was really aimed at assuaging public fears, i.e. the researchers themselves had earlier established what was the case.

Grant,

I’m a bit leery of his being “obliged” to check out “concerns” that have little merit – it’ll generally be an enormous waste of research dollars and time.

Having given it a little more thought, I’m sure you’re right. In any case, whatever study was done, the goalposts would undoubtedly simply shift.

I don’t understand any of this. What I do understand is how sick my daughter is after receiving 2 Gardasil vaccines. This is a dark place to be. Doctors don’t believe it, there are no cures, there is only hopelessness and desperation. I am not anti-vax and I don’t understand why that would even matter. When children are sick people care, doctors care, the medical community cares unless it is a Gardasil injury then everything is different. Why is this happening to us? Why won’t anyone help us? Why does anything related to Gardasil and injury seem to disappear from the internet. Can someone help us? Someone smart like the ones arguing this topic now. Does anyone care, is anyone listening? Please help my daughter, I love her, and I can’t help her.

@Summer Kennedy:

What I do understand is how sick my daughter is after receiving 2 Gardasil vaccines.

That doesn’t mean the Gardasil caused your daughter’s problems.

When children are sick people care, doctors care, the medical community cares unless it is a Gardasil injury then everything is different.

What evidence do you have that Gardasil caused your daughter’s problems? Forgive our scepticism, but anti-vaxxers have consistently blamed problems on vaccines even when there is no way the vaccines could have caused the problem.

I am not anti-vax

If you are blaming Gardasil for your daughter’s illness without any evidence other than “My daughter is ill and she has received two doses of Gardasil”, then yes, you are anti-vax.

Gardasil is sheer poison! It has affected boys too so no boys are not immune to its effects. The adjuvents are toxic,the dna included in the vaccine is dangerous, not to mention several of the other ingredients. More deaths from this vaccine then all other reported ever on VAERS. Many have been affected immediatly after the shot. Some of us USED to believe that vaccines were ok and doctors knew best, but we learned the hardest way possible- by hurting our children -that this is all about money for big pharma. So keep your ranting those of you employed by these companies, the rest of us are not fooled. Just please don’t subject your children to it, take it yourselves first and then determine if you want to give these miracle vaccines to your kids.

Gardasil is sheer poison!

Citation needed. (That’s shorthand for “simply asserting something to be true doesn’t make it true; if you’re going to make a claim, you need to back it up with reasons we should believe that claim.”)

It has affected boys too so no boys are not immune to its effects.

Citation needed.

The adjuvents are toxic,

Citation needed. Daaang, I think I’m gonna have to shorthand this shorthand. I’ll just say “CN” each time.

the dna included in the vaccine is dangerous, not to mention several of the other ingredients.

CN, CN.

More deaths from this vaccine then all other reported ever on VAERS.

And those who understand how VAERS works understand that, even if this were true, it would not mean what you think it does. VAERS casts a VERY wide net to try and identify hypotheses of vaccine-caused damage which MIGHT merit further investigation. An inevitable consequence of casting such a wide net is that it accepts reports where the facts are dubious – even reports where the submitter knows them to be false. Google “VAERS Incredible Hulk” if you don’t understand why “it was reported in VAERS” is not a good indicator that something actually happened as described.

Many have been affected immediatly after the shot.

Now, if you could substantiate this claim, you might actually start convincing people. A close temporal relationship between vaccine administration and adverse effects, in a large enough population, would definitely hint at a cause-effect relationship.

However, there’s very good reasons why we cannot simply say “AlexaF says it’s so; it must be so!!”

First off is that we know that people’s memories are significantly affected by what they believe to be so. If you ask someone who watched a black car slam into a blue car how fast the blue car slammed into the black car, they will most likely remember the blue car slamming into the black car, even though what they saw was the opposite. A fair number of them, if asked how fast the ambulance arrived, will give you a time estimate even though no ambulance ever arrived. If it’s possible to tamper with someone’s memory to this extent simply by asking questions in a leading way, parents who are exposed to a vigorous narrative of “Gardasil produces adverse effects in your boys and girls” will certainly misremember weeks and even months between the shot and whatever misfortune befell their child as “immediately,” and they will forget other events with possibly more relevance.

Second is that, frankly, sometimes the “misremembering” is intentional. The classic example is of course disgraced former doctor Andrew Wakefield, whose Lancet study turned out to have blatantly tampered with timelines to create an appearance of a temporal link when there wasn’t one.

So, again, CN. We need actual data, not just your assurance of what we should conclude from the data.

Some of us USED to believe that vaccines were ok and doctors knew best, but we learned the hardest way possible- by hurting our children -that this is all about money for big pharma.

I’m quite sorry for whatever happened to your child, but if you think merely having something happen to your child automatically tells you who did it, and why, you’re quite mistaken. That was the mistake made in the Salem Witch Trials. Or do you believe the parents who thought they “learned the hardest way possible” that old Goodwife Proctor was a witch who had afflicted their children to please her master Satan were CORRECT in that belief?

So keep your ranting those of you employed by these companies, the rest of us are not fooled.

ah, the Pharma Shill Gambit.

Just please don’t subject your children to it, take it yourselves first and then determine if you want to give these miracle vaccines to your kids.

Your concern for our children is appreciated, but your suggestion shows very little understanding of what vaccine adverse effects are really like. Take a vaccine, one of the first developed to fight rotavirus, which actually was found to cause a rare bowel complication in about 1 in 100,000 infants. Even if it was possible for that complication to happen to an adult who took the vaccine, do you really think “well, I took a 1/100,000 chance of something bad happening to me, and it didn’t, so that means it won’t happen to you either, Junior” makes sense? No. Actual surveillance programs are needed to detect such adverse effects, and by “actual surveillance programs” we don’t mean VAERS, because VAERS is only one component of such a system.

I’m not going to be as compassionate to Alexa F., as Antaeus Feldspar is.

What you have stated about Gardasil and other vaccines Alexa F. is straight from the anti-vaccine playbook….full of assertions without any “proof”, full of accusations (*Big Pharma*) shills, lacking in any citations from anywhere, except the crap you read on anti-vaccine websites…which leads me to believe you are “full of it”.

AlexaF:

More deaths from this vaccine then all other reported ever on VAERS.

What must you read and understand before using the VAERS database from its official portal at http://vaers.hhs.gov/data/index ? Explain why it says “I have read and understand the preceding statement.” before clicking on the button.

Shorter, even less compassionate response to AlexaF’s copypasta:

BWAHAHAHAHAHAHAHA!!!

Oh, and Citation Needed. 🙂

More deaths from this vaccine then all other reported ever on VAERS.

Wow, you didn’t even actually look. I’m impressed.

More deaths from this vaccine then all other reported ever on VAERS.

Gosh, it is as AlexaF feels free to fabricate complete bullsh1t without taking 30 seconds to check.* Always a good way to show off one’s concern for the truth.

* E.g. the VAERS figures for pertussis.

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