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Exaggerating conflicts of interest to sow fear, uncertainty, and doubt about vaccines

Remember Gayle DeLong?

Last summer, DeLong published a paper in the Journal of Toxicology and Environmental Health, entitled A Positive Association found between Autism Prevalence and Childhood Vaccination uptake across the U.S. Population. As I pointed out at the time, it showed nothing of the sort. Besides botching the introduction by citing a panoply of studies by luminaries of the antivaccine movement, such as Mark Blaxill, Mark and David Geier, Russell Blaylock, and Laura Hewitson, DeLong performed a simplistic analysis that had “ecological fallacy” written all over it in such big letters that I doubt even a first year epidemiology student would make such a huge mistake, unless, of course, that student is Jake Crosby. Let’s just put it this way, when an author cites a reference from a homeopath from 1884 to justify a point, you know you’re dealing with either serious incompetence, serious ideological bias, or both (usually both).

Unfortunately, Gayle DeLong is back. Apparently she’s managed to dupe another unwary journal editor and a couple of peer reviewers to let more of her nonsense pass into the peer-reviewed literature. As I’ve pointed out before, whenever I hear cranks, quacks, and antivaccine zealots complain that they are being “suppressed,” I like to point to someone like DeLong. Either that, or I point to someone like Mark Geier. After all, if they can inject their tripe into the peer-reviewed literature, it really can’t be all that high a bar to ask antivaccinationists and supporters of “alternative” medicine to cite peer-reviewed studies. Be that as it may, recently, DeLong provided yet more evidence (if any is needed) that simply being published in a peer-reviewed journal doesn’t necessarily mean that what’s there is anything to it. No, you have to think critically and look at the quality of the background science described to determine whether the hypothesis is sufficiently supported by science and evidence to be worth testing, the evidence used to support the hypothesis tested, and whether the methodology used was both appropriate and correctly carried out. In any case, this time around, DeLong has managed to get what appears to be more of a commentary than anything published in a journal called Accountability in Research entitled Conflicts of Interest in Vaccine Safety Research.

The first thing I thought of was that this is a journal I had never heard of before. Not that I think that having a journal dedicated to research accountability is a bad idea. Heck, one of the articles in the same issue as DeLong’s article appeared (The Vanishing Physician Scientist: A Critical Review and Analysis piqued my interest. Too bad my university doesn’t subscribe to this particular journal. However, the antivaccine crank blog Age of Autism is flogging this particular article, even going so far as to include a link to the PDF of the article, which, once again, makes me wonder how on earth that merry crew of antivacicne propagandists doesn’t bring the wrath of the publishing industry on it. The reason is obvious right from the very first paragraph:

How safe are vaccines? Health officials caution that no vaccine is 100% safe, but they sponsor studies that conclude the benefits of vaccines far outweigh the risks. Yet conflicts of interest (COls) cloud the study of adverse effects of vaccines, and public skepticism about vaccine safety information is widespread (ASTHO, 2010). Investigation into the possible link between childhood vaccines and autism provides an illustration of the competing interests that sponsors of vaccine safety research face that could affect their objectivity in choosing which studies to support. Much research is sponsored by vaccine manufacturers and public health bodies, who have financial and bureaucratic interests that could impede the objective study of vaccine safety. These companies and agencies adamantly deny a link between vaccines and autism, and argue that vaccines are one of the most important innovations in disease reduction in the 20th Century (CDC, 1999). They cite several studies that conclude a link between vaccines and neurological disorders cannot be established (Offit, 2008). Such research is often disseminated by medical journals that have financial reasons to promote the views ofthe research sponsors. Conversely,research promoted by some autism advocacy groups presents several overlapping and interwoven theories that link vaccines to autism. Researchers suggest that live viruses and the neurotoxins mercury and aluminum in some vaccines may be associated with neurological disorders (Jepson and Johnson, 2007).

Why, one wonders, would DeLong choose such an example? Her purpose is obvious: To sow fear, uncertainty, and doubt (FUD) about vaccines. This is obvious immediately. Notice how, right from the very beginning, DeLong establishes that her purpose is to try to cast doubt on the evidence supporting vacicne safety and efficacy based on what she implies are conflicts of interest so massive that they could lead to findings of vaccine safety issues being suppressed. In particular, notice how DeLong points out as an example of just such a vaccine safety issue the whole vaccine/autism manufactroversy. Then, note now DeLong then falsely “balances” vaccine safety data from the sources she clearly views as hopelessly tainted with evidence from brave maverick doctors who have “overlapping and interwoven theories” about how all sorts of nasty stuff in vaccines supposedly causes all sorts of nasty neurological disorders, of which autism is just the tip of the iceberg.

To me, a better term would be “wild-ass ideas that make no biological sense.” In fact, what DeLong characterizes as “overlapping and interwoven” I would characterize as “incoherent and conflicting.” Be that as it may, get a load of the reference she cites, namely Bryan Jepson and Jane Johnson’s Changing the Course of Autism: A Scientific Approach for Parents and Physicians. Jepson, regular readers might recall, was on staff along with Arthur Krigsman at Andrew Wakefield’s Thoughtful House back in the day when Wakefield still ran the place. If there’s anyone deeper into the vaccine-autism quackery than Bryan Jepson besides Andrew Wakefield, you’d be hard-pressed to find him or her. Jepson, Krigsman, Karzinel, and Wakefield were the Unholy Trinity of MMR vaccine fearmongering plus one. These days, the old team at Thoughtful House is no more, and Dr. Jepson has moved on to join up with the Integrative Sports & Wellness Medical Center.

So what are these “conflicts of interest” that so concern DeLong? Certainly, pharmaceutical companies have a COI. They are, after all, profit-seeking entities, and one could quite plausibly assert that they would have an incentive to minimize perceived vaccine risks. Certainly DeLong makes that argument. In particular, like pretty much all antivaccinationists, she really, really really doesn’t like the National Childhood Vaccine Injury Act of 1986, which established the Vaccine Court and required claims for vaccine injury to go through this special court first. Like most antivaccinationists who make this claim, DeLong neglects to discuss the full context of the law, namely that it was passed in response to a flood of lawsuits that threatened to drive vaccine manufacturing out of the United States because of liability fears. She also neglects to mention that the Vaccine Court uses lowered standards of evidence and pays for all reasonable legal costs of litigants who bring claims before it. She also regurgitates tired old tropes of the antivaccine movement about thimerosal/mercury in vaccines. In fact, her entire paper is notable for going on and on about potential COIs in which big pharma influences investigators to hide unfavorable results, but she can’t cite a single case in which this happened with respect to a vaccine.

DeLong then turns her sights to the usual targets of antivaccinationists. There’s a section on the FDA, which points out that the way the FDA can result in the FDA becoming closer to vaccine manufacturers. While this is a valid point that has been much discussed in policy debates and the medical literature, DeLong tries to twist it into an argument that goes this way:

A third conflict involves the National Vaccine Injury Compensation Program. Parents who believe their child may have been injured by a vaccine can file a claim in the Division of Vaccine Injury Compensation (DVIC). Both DVIC and the FDA are divisions of the U.S. Department of Health and Human Services (DHHS). If the information that the FDA is mandated to provide the public includes studies that show vaccines could be related to autism, it would be providing evidence for claims being filed within its own agency. As of December 2011, over 5,600 autism claims have been filed in DVIC. The average payout for vaccine-related injuries is close to $825,000 (DHHS, 2011), so the autism claims could cost the Program over $4.6 billion. Additionally, more parents would seek compensation if DVIC recognized autism as a vaccine injury.

Got it? According to DeLong, the FDA won’t acknowledge autism as a vaccine injury not because the science doesn’t support a vaccine-related etiology for autism, but rather because if it did admit that vaccines cause autism it would be providing evidence to the enemy, so to speak. Never mind that the standards in the Vaccine Court are already “50% and a feather,” as they have been characterized. Never mind that the FDA and the DVIC are not the same agencies. Just because they’re within the same Department doesn’t mean that they will work in lockstep. Finally, note the rather clever sleight-of-hand DeLong uses at the end. Notice how she points out that there have been 5,600 autism claims filed in the DVIC. Then see further how DeLong neglects to mention mention that the vast bulk of those claims come from the roughly 5,000 children whose cases were aggregated together in the Autism Omnibus proceedings and that the test cases used to establish whether there might be enough evidence to attribute autism to vaccine injury for purposes of the law went down in flames three years ago. I’m shocked that DeLong didn’t mention that, at least as a means of trying to imply that the reason the Autism Omnibus test cases failed so spectacularly was because of collusion between DHHS offices like the FDA and DVIC. Of course, pointing that out would require her to mention that the Special Masters resoundingly rejected the claim of autism causation by vaccines and that they did so even under the less stringent standards of the Vaccine Court. That wouldn’t do. DeLong also recycles this same argument with the CDC, pointing out that the CDC is also part of DHHS as well. The perfidy!

But it’s not just big pharma, the FDA, DVIC, and CDC. Oh, no! It’s everybody! To DeLong, pretty much every scientist is on the take from big pharma, everyone working for the CDC is just one step away from taking a lucrative job with vaccine manufacturers, and the medical journals are so dependent on pharma that you can’t believe anything they publish. With the exception of the conspiracy mongering about the FDA, DVIC, and CDC working in collusion because they’re all part of the DHHS, there’s a grain of a good point in some of what DeLong says, but just a grain. She takes legitimate criticisms of how science is done, and, like the antivaccine crank that she is, strips them of any nuance, tries to build elaborate interactions between various organizations such that they are all working against the brave maverick doctors and the parents who believe that vaccines cause autism, and turns the paranoia up to 11. How she got away with this in an ostensibly peer-reviewed journal is depressing to contemplate. One wonders what her first version looked like before peer reviewers returned her first submitted manuscript with their critiques.

Finally, if you want to get an idea of what DeLong’s idea of “balance” is, take a look at what she says about advocacy groups (or, what I refer to as antivaccine crank groups):

These groups consider that vaccines or vaccine ingredients may be associated with autism and have a reputational interest in the outcome of the research. Some members of these organizations also have a legislative agenda that includes enacting laws to allow vaccination choice and allocating more resources to the study of vaccine side effects (Habakus and Holland, 2011). Parents of children with autism or other neurological disorders founded many of these groups; some of the parents have filed claims under the U.S. Vaccine Injury Compensation Program. Therefore, some individuals associated with these groups have a financial interest in seeing research that establishes a link between vaccines and autism. These organizations sponsor relatively small projects: ARI grants average about $20,000 (ARI, 2012), and SafeMinds grants range from $5,000 to $75,000 per year (SafeMinds, 2012); the entire research budget for NVIC is roughly $100,000 (NVIC, 2012). While these organizations are not as well-staffed or well-funded as government agencies or vaccine manufacturers, their main task is to generate information to refute agency or industry claims. In so doing, they are known to fund research to help bolster their position. Although there is limited oversight concerning the general information these groups disseminate, the research they sponsor goes through the same vetting process as any other research that appears in peer-reviewed journals.

Notice how DeLong tries to equate COIs primarily with financial interests, implying that, because these “vaccine safety” organizations cum antivaccine groups have such tiny budgets and offer such tiny grants for vaccine safety “research” compared to the resources of the federal government and big pharma, their COIs must be inconsequential. After all, all these groups have are relatively small financial interests, plus “reputational” interests in turning out to be right. What DeLong neglects to mention is that it’s way, way more than a “reputational” interest in being right that drives these groups. The founders and members of these groups not only profoundly believe that vaccines are unsafe and cause autism, but, because many of them have children with autism that they blame on vaccines, they also have a profound emotional investment in the concept that vaccines cause autism. This emotional investment in the vaccine/autism idea manifests itself as an unrelenting inability to admit error or to accept scientific evidence that conflicts with the idea that vaccines cause autism. DeLong herself should know, as she herself is one of those parents. Indeed, she was on the executive board of SafeMinds, as I pointed out in my first post about her and Emily points out. DeLong even acknowledged that she was “on the board of directors and research committee of Sensible Action for Ending Mercury-Induced Neurological Disorders (SafeMinds)” in her first article.

Interestingly, if you look at the SafeMinds board of directors now, Gayle DeLong is no longer listed there, nor is her description, cited by both Emily and myself the last time DeLong contaminated the literature with her antivaccine propaganda:

Dr. Gayle DeLong is a parent of two girls with autism. Starting in May 2005, her family began biomedical interventions to treat the girls’ illness. Both girls have benefited greatly from supplements, diet, chelation, and hyperbaric oxygen therapy. Gayle holds a Ph.D. in international business and finance from New York University as well as an International Master’s in Business Administration from the University of South Carolina. She teaches international finance at Baruch College, City University of New York. She serves on SafeMind’s research committee. She has attended rallies in Washington, DC to promote safer vaccines and spoken against adding vaccines to New Jersey’s mandated schedule at a public hearing in Trenton, NJ. She lives with her husband and two daughters in Morristown, NJ.

And what does Dr. DeLong say about her COI for the paper? Here it is:

The author has two daughters with pervasive development disorder, not otherwise specified. She has filed a petition in the U.S. Court of Federal Claims under the National Vaccine Injury Compensation Program for one of her daughters. The author is a former member of the board of directors of Sensible Action for Ending Mercury-Induced Neurological Disorders (SafeMinds).

Very good. At least she disclosed her COI. However, I do wonder why DeLong is no longer on the board of directors of SafeMinds. Could it be that she realized that being on the board of an antivaccine organization makes it less likely that anyone in academia will take her seemingly “scholarly” articles seriously? Inquiring minds want to know.

Now that we’ve established that Dr. DeLong’s article is a blatantly biased bit of antivaccine propaganda, I’ll finish with the difference between an antivaccinationist and a scientist. Regardless of DeLong’s affiliations, a real scientist will look at her arguments and determine if they hold water, which is what I tried to do right here in this very blog post. If they do, that scientist might be persuaded. DeLong’s arguments, not surprisingly, do not persuade. Now let’s imagine the situation were reversed and it is the antivaccinationist evaluating the claims of a scientist arguing for vaccines. Oh, wait. We don’t have to imagine that. Just look at how antivaccinationists savage Paul Offit for having worked with a pharmaceutical company to bring a vaccine to market. Because of that, no matter what he says, they will not believe him. No matter how much science he brings to bear, no matter how much evidence he presents, no matter how informed his arguments are based on science, not only will they not believe Offit, but they continue to seek to discredit him by any means necessary.

The difference couldn’t be more clear, and DeLong’s articles illustrate it quite nicely.

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]

111 replies on “Exaggerating conflicts of interest to sow fear, uncertainty, and doubt about vaccines”

DeLong performed a simplistic analysis that had “ecological fallacy” written all over it in such big letters that I doubt even a first year epidemiology student would make such a huge mistake,

Not only that, but she conflated ASD with speech impairment. Y’know, things like stuttering.

“even going so far as to include a link to the PDF of the article, which, once again, makes me wonder how on earth that merry crew of antivacicne propagandists doesn’t bring the wrath of the publishing industry on it”

One XMRV-CFS forum even had their own in-house repository of pirated papers that you logged into – they were effectively re-publishing the material. (This same forum copied one of my blog post verbatim. I asked them to reduce it and refer to the original, but I don’t recall them ever replying.)

So, what about all of the hundreds, mostly likely thousands of drugs that never make it out of clinical trials? Did Big Pharma just not pay the FDA enough to get them passed-through or do they get a quota based on the amount of money they pay?

At last, Dr. Orac has provided an unbiased view of vaccination risk! Unlike the pro and anti vaccinationists, who have been assailed with allegations of bias, Dr. Orac has explained all the tendentious nonsense that is proffered for the consumption of the naive as the produce of irrational thinking. Thank you Dr. Orac for being at long last the unbiased voice we all
look for!

Hell, I ain’t a scientist, or even that bright. But it wouldn’t surprise me if one day, despite all the facts presented,it turned out a small group of susceptible children developed brain injury due to vaccines, in an atypical antigenic cascade.

@usethebrains
Why would you suspect such a thing?
How small is small? Fewer than those injured or killed by vaccine preventable disease?
When you say, “desspite of all the facts presented”, do you mean some facts are hidden (conspiracy theory) or that life is complicated and difficult (science makes mistakes), or are you positing a genetic predisposition as yet undiscovered?

@usethebrainsgodgiveyou

Brain damage can occur in very rare cases, for example, there is a roughly 1 in 1,000,000 risk of encephalitis following MMR. But autism is not necessarily brain damage. Rather, the growing evidence suggests the spectrum are due to differences in brain development, especially during fetal development in the womb.

As to conflicts of interest, DeLong should perhaps consider, as Orac points out, how non-financial conflicts can play a role.

mark provides a good example of why sarcasm is a favored tactic of poor arguers. With sarcasm, you can simply keep spewing things that you make clear you don’t think people should really believe and neatly sidestep the issue of: what do you believe?

If mark’s sarcastic rant were stripped of its sarcasm, for instance, he would have to admit that he is accusing Orac of pretending not to have any bias but actually having some after all. Then he would have to deal with such uncomfortable questions as “Did Orac ever say ‘I don’t have any bias’ or is that just a strawman?” Since the entire point of Orac’s article is that one cannot ignore actual evidence and pay attention only to alleged bias and expect that to produce meaningful guidance, to attack Orac with “You must have some bias somewhere!” is pretty incompetent in terms of actual meaningful discussion.

Apparently she’s managed to dupe another unwary journal editor and a couple of peer reviewers to let more of her nonsense pass into the peer-reviewed literature.

I think you are being kind here Orac. I doubt the reviewers were duped and, in my opinion, articles such as these are readily accepted to bolster readership particularly since the journals they are getting into aren’t much more than gussied-up vanity press.

A conflict of interest does not automatically invalidate a paper or a researcher’s findings.

However, it does send up a flag for readers to be more skeptical of any findings presented and is a viable causal factor if the findings or claims are found to be wrong.

mark provides a good example of why sarcasm is a favored tactic of poor arguers. With sarcasm, you can simply keep spewing things that you make clear you don’t think people should really believe and neatly sidestep the issue of: what do you believe?

If mark’s sarcastic rant were stripped of its sarcasm, for instance, he would have to admit that he is accusing Orac of pretending not to have any bias but actually having some after all. Then he would have to deal with such uncomfortable questions as “Did Orac ever say ‘I don’t have any bias’ or is that just a strawman?” Since the entire point of Orac’s article is that one cannot ignore actual evidence and pay attention only to alleged bias and expect that to produce meaningful guidance, to attack Orac with “You must have some bias somewhere!” is pretty incompetent in terms of actual meaningful discussion.

For all the incentives that Big Pharma has to minimize the perceptions of risk of vaccines, they have an even larger incentive to minimize the actual risk of vaccines.

Why wouldn’t they spend money minimizing the actual risks of vaccines instead of just covering it up?

Some vaccines are decades old. One-time investment in improving their safety would be a lot cheaper than ongoing payments to myriad pharma shills to lie about the coverup.

Why hasn’t this been done with a single vaccine?

DeLong writes: “The average payout for vaccine-related injuries is close to $825,000”

Personally, she could benefit to the tune of $825,000 if she is correct. And she has the nerve to argue that there is no real conflict of interest because SafeMinds et al have small budgets.

The statement that really hit me in the face was DeLong’s statement regarding the antivaccination groups that

“their main task is to generate information to refute agency or industry claims.”

Who talks like that? Shouldn’t their main task to be seeking truth? Or maybe to rovide an independent check on scientfic claims from other bodies?

The fact that someone deeply involved with these groups could make this statement without blinking shows they are hopelessly bound by conflict of interest. They can’t even put language together to give the appearance of objectivity. The fact that they are admittedly driven by an agenda rather than truth is why their work should never see the light of day in peer-reviewed literature.

While these organizations are not as well-staffed or well-funded as government agencies or vaccine manufacturers, their main task is to generate information to refute agency or industry claims.

Interesting wording there. Their main goal is not to provide accurate information but to “refute agency or industry claims”.

Either they are assuming that “agency or industry claims” are false or, well, why would they “refute” claims which are accurate?

BKsea and Matt hit on the same nonsense from DeLong. Great minds and all that. No objectivity, just opposition.

MikeMa,

Funny isn’t it? The usual phrases are that they want to provide accurate information so that consumers can make an informed choice. Perhaps a co-author would have caught that and reworded it to be less telling.

I need to look at the paper again. Does the author even bring up advocacy groups which are pro-vaccine?

Lucky Miss. Delong didn’t mention the study, “Weight of Evidence Against Thimerosal Causing Neuropsychological Deficits”. This study was published by The New England Journal of Medicine. Let’s take a look at conflicts of interest of some of the study’s authors:

* Dr. Thompson – the lead investigator – is a former employee of Merck.

* Dr. Marcy has received consulting fees from Merck, Sanofi Pasteur, GlaxoSmithKline, and MedImmune.

* Dr. Jackson received grant money from Wyeth, Sanofi Pasteur, GlaxoSmithKline, and Novartis. He received lecture fees from Sanofi Pasteur and consulting fees from Wyeth and Abbott. Currently, he is a consultant to the FDA Vaccines and Related Biological Products Advisory Committee.

* Dr. Lieu is a consultant to the CDC Advisory Committee on Immunication Practices.

* Dr. Black receives consulting fees from MedImmune, GlaxoSmithKline, Novartis, and Merck, and grant support from MedImmune, GlaxoSmithKline, Aventis, Merck, and Novartis.

* Dr. Davis receives consulting fees from Merck and grant support from Merck and GlaxoSmithKline.

The article then states, “No other potential conflict of interest relevant to this article was reported.” One must wonder; would it have been easier to identify researchers who don’t have a conflict of interest?

Any child with a preexisting neurological condition was eliminated from the study. However, is it not possible, in fact, probable that these children are the most at risk from exposure to thimerosal? Any child who developed certain neurological conditions was excluded. These conditions included encephalitis and meningitis. The possibility that thimerosal might cause these conditions was eliminated from consideration.

Other children were eliminated for various other reasons. One group excluded was children whose birth weight was under 2,500 grams, about 5.5 pounds. How many babies were eliminated for being underweight is not stated. Babies of this weight are hardly rare and they are not excluded from vaccinations. What legitimate reason could be given for this exclusion?

In the end, only 30% of the originally-selected children were included in the study.

I don’t know about you Dr. Orac, but how does the medical community defend pure fraud? The New England Journal of Medicine is crazy to destroy it’s storied reputation publishing fraud.

Oh lord! She sounds like the nonsense I survey at that stench-emmitting sinkhole of decayed logic and noxious grandiosity( Progressive Radio Network; similar, NaturalNews): they entice their audiences with citations from pseudo-scientists and advocacy groups, research that mostly appears in wank-journals, crying COI and ” the injured were paid”- leaving out details, especially the salient ones.

Usually, they invoke the tired old: ‘Orthodox science is totally compromised and in bed with the government, industry and the media *simultaneously* so don’t you believe them!’ Then, they present themselves as the alternative presently riding upon the incoming wave of cleansing New Science.

Orac picks up something I’ve noticed: if you look closely at autism/ advocacy groups, the same names keep popping up: Blaxill, Habakus, (new) McNeil, Loe Fischer et al: it’s a very small cadre of vested interests who portray themselves as reformers representing a large portion of the population- they’re not: they’re like an animal puffing itself up to appear larger and a more formidable opponent. Unfortunately, even the small numbers under their sway can wreck havoc.

Penelope, could you post the PubMed identification number for that paper, please? I cannot find it in PubMed.

Penelope

Babies of this weight are hardly rare

What do you consider rare, Penelope? Less than 5% of the population? Less than 2%? Because that’s what we’re talking about at that birthweight.
See the WHO growth charts. I’m linking the chart for girls, since they’re usually smaller than boys. http://www.cdc.gov/growthcharts/data/who/grchrt_girls_24lw_9210.pdf

Many children with this birthweight are also premature, and while studying those children will help clarify issues for that population, it won’t be generalizable to children who were born at full term.

I had to pare down the search terms to just “Thimerosal Neuropsychological” before I got any papers. And then I only found ten:

Thimerosal exposure in early life and neuropsychological outcomes 7-10 years later.
Barile JP, Kuperminc GP, Weintraub ES, Mink JW, Thompson WW.
J Pediatr Psychol. 2012 Jan-Feb;37(1):106-18. Epub 2011 Jul 23.

On-time vaccine receipt in the first year does not adversely affect neuropsychological outcomes.
Smith MJ, Woods CR.
Pediatrics. 2010 Jun;125(6):1134-41. Epub 2010 May 24.

Thimerosal exposure (from tetanus-diphtheria vaccine) during pregnancy and neurodevelopment of breastfed infants at 6 months.
Marques RC, Dórea JG, Bernardi JV.
Acta Paediatr. 2010 Jun;99(6):934-9. Epub 2009 Dec 9.

Autism: an update.
Goldson E.
Adv Pediatr. 2009;56:187-201. Review. No abstract available.

Prenatal and postnatal mercury exposure, breastfeeding and neurodevelopment during the first 5 years.
Marques RC, Dórea JG, Bernardi JV, Bastos WR, Malm O.
Cogn Behav Neurol. 2009 Jun;22(2):134-41.

Neuropsychological performance 10 years after immunization in infancy with thimerosal-containing vaccines.
Tozzi AE, Bisiacchi P, Tarantino V, De Mei B, D’Elia L, Chiarotti F, Salmaso S.
Pediatrics. 2009 Feb;123(2):475-82.

Early thimerosal exposure and neuropsychological outcomes.
Rooney JP.
N Engl J Med. 2008 Jan 3;358(1):93-4; author reply 94. No abstract available.

Early thimerosal exposure and neuropsychological outcomes.
Bernard S.
N Engl J Med. 2008 Jan 3;358(1):93; author reply 94. No abstract available.

Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years.
Thompson WW, Price C, Goodson B, Shay DK, Benson P, Hinrichsen VL, Lewis E, Eriksen E, Ray P, Marcy SM, Dunn J, Jackson LA, Lieu TA, Black S, Stewart G, Weintraub ES, Davis RL, DeStefano F; Vaccine Safety Datalink Team.
N Engl J Med. 2007 Sep 27;357(13):1281-92.

Time of perinatal immunization, thimerosal exposure and neurodevelopment at 6 months in breastfed infants.
Marques RC, Dórea JG, Manzatto AG, Bastos WR, Bernardi JV, Malm O.
Acta Paediatr. 2007 Jun;96(6):864-8. Epub 2007 Apr 27.

Now going through that list and matching up the authors, I suspect it is “Early thimerosal exposure and neuropsychological outcomes at 7 to 10 years” from June 2007. Well, that is funny! That is exactly the same one that Sallie Bernard helped design! So, Penelope, if you have any issues with the design of the study, shouldn’t you bring that up with Ms. Bernard?

Penelope:

Here’s a challenge for you:

(1) Re-visit the NEJM study you are decrying as ‘fraud’.
(2) Review the study to see on what basis the excluded children were excluded (not just what criteria, which you have outlined, but also why those criteria were applied)
(3) Explain why you think the exclusion criteria were wrong, not just as a matter of unsubstantiated assertion but as a matter of study methodology – although if the exclusion criteria are the result of IRB or ethical criteria you may not have a good case.
(4) Provide cites to substantiate your conjectures regarding neurological conditions and your complaint against excluding underweight babies.

Unless and until you can show that the NEJM paper to which you object has clear methodological flaws or fabricated/misrepresented data, and that those problems follow from the COIs you find so suspicious, your accusation of fraud is baseless.

Ooops, I misread myself. The study was N Engl J Med. 2007 Sep 27;357(13):1281-92, from September 2007!

Next time, get the title and date of the paper correct. And remember Penelope, Sallie Bernard of SafeMinds helped with its design. From the link I posted:

Ms. Bernard was a consultant on this study and helped contribute to its design! She apparently didn’t like the results that it was producing and decided to drop out and start criticizing it–even jumping the gun on the 5 PM embargo yesterday to do so! Indeed, she is listed on the study in a way that I’ve never seen before: as a “dissenting member.”

The fact that an entity is tasked with the job of pushing a product does not mean conflicts of interest will prevent that entity from doing good research on those products. Heck, the tobacco company scientists produced reams of reliable, accurate information about cigarettes for decades.

Penelope, you do realize that Sallie Bernard contributed to the design of the study. You also must realize that I’ve already written about this particular study at least a couple of times:

http://respectfulinsolence.com/2007/09/a_bad_day_for_antivaccinationists.php
http://respectfulinsolence.com/2008/01/sallie_bernard_responds_to_the_new_engla.php

Steve Novella also wrote a good commentary:

http://theness.com/neurologicablog/index.php/more-evidence-for-the-safety-of-vaccines/

Even more quaint, Gayle DeLong pulled the “tobacco science” schtick in her article. I just didn’t mention it because it’s such a hoary old trope of the antivaccine movement (it is, after all, beloved of Dr. jay Gordon) that it hardly seemed worth batting down in the context of all the other egregious nonsense she included in her article.

even going so far as to include a link to the PDF of the article, which, once again, makes me wonder how on earth that merry crew of antivacicne propagandists doesn’t bring the wrath of the publishing industry on it.

Were they originally serving it themselves? It’s now been offloaded to rescuepost.com with a comment that makes it look as though they originally had an arrangement with T&F. Of course, even if they did, this leaves them with the same DMCA come-hither look on their faces. (Although GoDaddy’s foot-dragging process guarantees that the damage will have been done regardless.)

Just for fun, I ran through the CCC rights and permissions quick pricing. If the material represents more than 20% of the content in the context for which permissions are being sought (which I would say it certainly does in this case), you’re out of luck, i.e., AoA would be lying if they pretended they had purchased limited redistribution rights.

If it represents 20% or less, the permission has to be obtained by snail mail. Color me cynical, but if they had gone to this trouble, there’s no way they would turn around and upload it to Rescuepost.

Heck, the tobacco company scientists produced reams of reliable, accurate information about cigarettes for decades.

How cute, Sid is taking a page from Jake Crosby’s book now. Emphasis mine; there was nothing reliable nor accurate about the information which was why it didn’t withstand replication nor scrutiny. And worth noting your group’s beloved Dr. Healy was a staunch defender of the tobacco industry and it’s “science”.

-btw- I saw Jake’s so-called writing over at AutismOne recently- the boy is spreading the, um… *wealth* (for lack of a better word).

As far as I can see, Penelope’s arguing one can never trust evidence produced by or conclusions derived by anyone who has ever actually had advanced education in and/or real-world, hands-on professional experience in assessing risks versus benefits of drugs or vaccines. Simply by being or having been ‘part of the system’ they are subject to insurmountable conflicts of interest.

If it’s true that esperts, simply by being employed in a field, cannot be trusted to offer accurate conclusions about subjects in that field, should you have a leaky pipe it’s time to call the hair-dresser, or bartender, or florist (anyone but a plumber). Tax advice? Find a dockworker, or landscaper (anyone but a tax accountant).

Car broken down? Maybe a pastry chef…

I guess if you ascribe to that view, it makes perfect sense to direct questions regarding food safety or property rights to someone with a degree in Fire Science…

“Usethebrainsgodgaveyou”, in an explosion of inadvertent irony (#6):

“Hell, I ain’t a scientist, or even that bright. But it wouldn’t surprise me if one day, despite all the facts presented,it turned out a small group of susceptible children developed brain injury due to vaccines, in an atypical antigenic cascade.”

“An atypical antigenic cascade”? What the hell would that be? Apart from clearly proving the first sentence with the second, “Use…” has given an excellent example of a phrase that sounds all “sciency” but actually means nothing.

Even a “typical antigenic cascade” would be a meaningless phrase, since antigens don’t “cascade”, typically or atypically. And before the self-admitted not-that-bright-non-scientist “Use…” claims that he/she meant “antibody cascade”, that doesn’t mean anything, either. “Cytokine storm” might be what was meant, but there isn’t any indication that autism is caused by cytokine storm. Besides, cytokine storm isn’t a subtle event and often leads to death.

I’m curious – if “Use…” is still out there, where did he/she come across this phrase?

Prometheus

I believe Penelope means this paper: Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years

That is kinda hilarious. According to the Great Google, there are 281 webpages citing this paper that doesn’t exist under Penelope’s title. Some of them are letters to Salon and the like, complaining that some author has not acknowledged the non-existent paper, but the vast majority are the usual anti-vaccine sites, showing their scholarship by endlessly churning yet another spurious misstatement that confirmed their preconceptions and which they couldn’t be bothered checking because the NEJM searchable index is so difficult to use. The popularity of this non-existent title is a microcosm of the anti-vax reverberation network.

Let’s take a look at conflicts of interest of some of the study’s authors:
Followed by claims about six authors. Assuming that “Early thimerosal exposure” is the paper that Penelope intends, an honest account of the authors’ independence would note that there are 18 authors in total, plus six external consultants (including Bernard).

I don’t know about you Dr. Orac, but how does the medical community defend pure fraud? The New England Journal of Medicine is crazy to destroy it’s storied reputation publishing fraud.

I don’t know about you Penelope but how do you defend your parroting of someone else’s mendacious claims about a publication that you clearly haven’t read or even tried to find?

Let’s see. You enroll 5,000 kids in a study. You weed out 3,500 and don’t explain why. You’re left with 1,500 kids who are the brightest and healthiest. You then give them a suedo-scientific test and then declare organic mercuy injection in newborns and infants is harmless.

This isn’t science. This is statistical manipulation and nothing else. This is fraud. This is why Sallie Bernard was livid. She was used by the “good ole boys”.

How does this differ from saying we looked at 500,000 people who smoke and 500,000 who don’t. We saw no difference in lung cancer rates after eliminating every smoker who developed lung cancer from the study. This is inspite of millions of people showing up in Doctors office’s daily with black lungs and cancer.

Tobacco science and “injecting babies with mercury is safe” science is identical. You people lack commonsense!

Beyond the question of whether any association with a drug company at any time irreversibly taints a study author, I am wondering about this “conflict of interest” cited by Penelope:

“Dr. Lieu is a consultant to the CDC Advisory Committee on Immunication Practices” (I’m guessing she meant “Immunization”).

Working with the CDC is a “conflict of interest”? What a farcical conspiracy world these people live in. No one but them has any concern for public health or has children whose safety they want to protect. There must not be any parents of young kids working at the CDC, or else they’re all sociopaths who don’t care about them. Ditto Merck et al; they’ve all got to be sociopaths or robots immune to infectious diseases.

Sid / Robert seems to forget that there was plenty of independent research that showed tobacco smoke was bad, which is why the tobacco companies ultimately settled the government lawsuits.

Show us the research the contradicts all of the vaccine studies. Even if you’re harping on the Pharma / FDA connections, there are still plenty of international studies, by both educational and research institutions that refute the vaccine / autism link.

You are preaching about a “perfect” conspiracy, much like what our Morgellon’s fanatic was pushing recently – the amount of time, money & people involved would be beyond the realm of possibility. Even the tobacco situation was incredibly porous – you had plenty of whistleblowers, reports, and investigations that piled up over the years, so the situations aren’t really comparable, as much as you would like them to be.

Wow, Penelope, that may be the worst example of false analogy that I’ve ever seen.

Are you really saying that the 3500 children that you claim were excluded from the study all developed adverse effects from the injection? Because that’s precisely what your analogy implies.

Let’s see. You enroll 5,000 kids in a study. You weed out 3,500 and don’t explain why. You’re left with 1,500 kids who are the brightest and healthiest. You then give them a suedo-scientific test and then declare organic mercuy injection in newborns and infants is harmless.

This isn’t science. This is statistical manipulation and nothing else. This is fraud. This is why Sallie Bernard was livid. She was used by the “good ole boys”.

… nothing at all like the real study, which you obviously haven’t read.

Seems Penelope doesn’t know anything about trying to eliminate “false positives” from either this or any study. It doesn’t do any good to include members in a group that you know will only skew the overall results for the wrong reasons.

You weed out 3,500 and don’t explain why.
You haven’t read the paper, have you, Penelope?

You then give them a suedo-scientific test
You haven’t read the paper, have you, Penelope?

“Let’s see. You enroll 5,000 kids in a study. You weed out 3,500 and don’t explain why. ”

Have you read the paper?

Of 3648 children selected for recruitment, 1107 (30.3%) were tested. Among children who were not tested, 512 did not meet one or more of the eligibility criteria, 1026 could not be located, and 44 had scheduling difficulties; in addition, the mothers of 959 children declined to participate

The largest group who did not participate couldn’t be found. The second largest group was for families who declined to participate.

Also,

Children were excluded if they had certain conditions recorded in their medical records that could bias neuropsychological testing (e.g., encephalitis, meningitis, or hydrocephalus) or if their birth weight was less than 2500 g (Table A of the Supplementary Appendix, available with the full text of this article at http://www.nejm.org).

Penelope:

Please provide credible evidence is support of your claims that:

that the authors of the study enrolled 5000 subjects

the authors then excluded 3500 of these subjects
without explaining why they were excluded

the remaining 1500 actually represented uniformly
bright and healthy individuals, rather than remaining a
representative sampling of varied intelligence and
health

the authors then administered an invalid “seudo- scientific test”

Tobacco science and “injecting babies with mercury is safe” science is identical.

Please identify exactly which study you’re referring to here. I’m unaware of any studies where babies were lnjected with mercury, and in fact don’t see how such a study could possibly be approved by an internal review board.

Wait! You wouldn’t simply be making all this up, would you?

JGC, I think Penelope would have to read the paper first in order to answer those questions. Considering the name of the paper was incorrectly cited in her first post I rather doubt she has done this.

Shouldn’t being called on mistakes like this and your ignorance of tobacco science make you question how much you actually know about these subjects and wonder if you have been misinformed?

I think herr doktor bimler had a good point that should be addressed.

I don’t know about you Penelope but how do you defend your parroting of someone else’s mendacious claims about a publication that you clearly haven’t read or even tried to find?

Particularly amusing that Penelope doesn’t seem to comprehend that excluding various confounding groups is a completely standard part of a study like this. You look in the groups which will give you the clearest signal of the effect you’re looking for, and exclude the groups which will provide noise but no signal.

Accordingly, any valid criticism must not simply be that exclusions took place, but must explain how those exclusions biased the results. And should be more than speculation that MAYBE some signal MIGHT have been found in a particular excluded group because of some reason made up after the fact to justify rejecting the results.

@Penelope

If the study to which you are referring is the one linked to by Matt Carey at #27, then a) your numbers are horribly off and b) you really don’t understand the methods section (assuming you even read the study, which, as others have opined, you appear not to have done). The researchers excluded children with a history of certain medical conditions that could confound the neuropsychological testing (e.g., encephalitis, meningitis, etc.). You see, the researchers wanted to see if thimerosal caused neuro. disorders or adverse changes. If a child had a history of having had meningitis (e.g., due to a bacterial or viral infection), then the researchers would not have been able to determine whether any negative neurological changes were due to the thimerosal exposure or due to the meningitis.

I hope that makes sense to you now.

The researchers excluded children with a history of certain medical conditions that could confound the neuropsychological testing (e.g., encephalitis, meningitis, etc.).

In fact if they *hadn’t* excluded those confounding factors, there would have been a chorus of complaints and accusations that the authors were driven by ulterior motives and were trying to skew their results and hide the truth behind a cloud of statistical manipulation.

the authors then excluded 3500 of these subjects without explaining why they were excluded

I’m guessing that what Penelope means here is that they didn’t come round with a whiteboard and and knock at her door to explain to her in person in the course of a 50-minute seminar why they excluded some cases. Rather than explaining it in the paper, which you can’t expect her to read.

Thanks Penelope. I appreciate your posts.
You provide an excellent example as to why those seeking genuine information on vaccination need to ignore the scientifically illiterate, deceitful and dangerous propaganda disseminated by antivaxx ideologues.

You enroll 5,000 kids in a study. You weed out 3,500 and don’t explain why. You’re left with 1,500 kids who are the brightest and healthiest.

I feel compelled now to quote actual facts for comparison with Penelope’s messages from an alternative reality:

Of 3648 children selected for recruitment, 1107 (30.3%) were tested. Among children who were not tested, 512 did not meet one or more of the eligibility criteria, 1026 could not be located, and 44 had scheduling difficulties; in addition, the mothers of 959 children declined to participate. […] Of the 1107 children who were tested, 60 were excluded from the final analysis for the following reasons: […] Thus, 1047 children were included in the final analyses.

@ Science Mom: Thanks to you for finding the whale.to (unpublished) “Letter to the Editor” that “Penelope” did not attribute to Michael Wagnitz. Wagnitz’s “specialty” is writing articles that attack researcher’s credentials:

http://autismrealitynb.wordpress.com/category/michael-wagnitz/

Wagnitz is also on the Science Advisory Boards of autism advocacy associations, along with other “experts”…well-known to the RI “regulars”:

http://www.nationalautismassociation.org/advisory.php

http://autismmedia.org/media4.html

Whose research tried to replicate and scrutinize the work of big tobacco?

Oh no one’s Sid; the idea that tobacco was a health hazard just materialised out of thin air [/sarcasm]. Avail yourself of the reading materials that were provided to you by others lest you continue to compete with Penelope as a bit informationally-challenged.

Penelope seems to be channelling Jake Crosby and plagiarising Mike Wegnitz master of appealing to one’s own very paltry authority with her assertions of “seudo-science”. Perhaps she would be so kind as to answer JCG’s questions @ 45 so that we may gain an understanding of what, exactly she is frothing at the mouth about. Hint: external validity, bias, confounding.

@ Prometheus:
@ Dangerous Bacon:

Oh where to begin! First of all, if you listened to that font of wisdom ( see my # 20 above) you’d realise that an *antigenic cascade* or *cytokine storm* is not a rare event but occurs *each* and *every* time that you ingest a hamburger or a pizza! Well, I guess you toxic boys wouldn’t even notice *that*! Not only are you entirely in the pocket of the Orthodoxy but you are slowly *killing* yourselves by believing in your own bad science! Some day you will *regret* it as you lie dying a victim of your own hubris and lack of supplements!
The CDC is amongst the most corrupt coteries of compromised individuals upon the face of the planet! Sociopaths *all*! Statistical manipulation is rampant amongst these so-called scientists.. especially the tried and true *exclusion of subjects* method. Needless to say, woefully malfeasant journalists report this *unchallenged* as they line their wallets with pharma gold!

The pre-ceding is an exercise called “What would I sound like if I were a woo-meister?” ( you can tell that it’s not real because in truth I would never stoop to using *alliteration*- although I think my phrases are too complex- dead giveaway- but the prosody markings work).

herr dokter bimler:

I don’t know about you Penelope but how do you defend your parroting of someone else’s mendacious claims about a publication that you clearly haven’t read or even tried to find?

There seem to be a common tactic among the anti-science folks to cut and paste from select websites without even looking for the paper themselves, nor even bother to read the papers. This is why we have Penelope not even knowing the name of the paper in question, and Witch claiming a paper showed Gardisil did not prevent HPV when it was a paper showing that Cevarix did not treat women who were already infected.

They do not have the tools nor the will to research the claims. They simply cannot think for themselves, they are just content to have the misinformation spoon fed to them if it supports their beliefs.

I also noticed that while I was searching for the paper I found with that there were other papers published that came to the same conclusion: thimerosal in vaccines does not cause autism or other neurological and physical problems.

Our resident “libertarian” is tweeting about Loe-Fisher’s latest screed on AoA:

There could be a conflict here. If a libertarian doesn’t trust industry-funded medical research because of the conflicts of interest, what there the alternatives? — other than disinterested medical research funded by the evil government using stolen money.

@ herr doktor bimler: Our “libertarian” also posts this on his “Vaccine Machine” blog:

“The Vaccine Machine was founded in 2010 to educate parents about both the risks of vaccines and the infectious illnesses for which they provide protection. The Machine about which we write is comprised of the vested interests in government, science and industry whose mission it is to vaccinate every man, woman and child by any means necessary. Our blog fights the misinformation and propaganda disseminated by the Machine and its unwitting media allies and stands firmly in opposition to the forced vaccination of America’s children.”

The *choice of his ‘nym* is indicative of his absolute jealousy of one of our most respected researchers/clinicians.

(Poor Bob, ain’t no one paying him for his “education”, “credentials” and “expertise” in *fire science*)

“The Vaccine Machine was founded in 2010 to educate parents about both the risks of vaccines and the infectious illnesses for which they provide protection.”

Sure, because Sid is such an expert in vaccinology and infectious diseases. What hubris.

Gayle DeLong:

Conversely,research promoted by some autism advocacy groups presents several overlapping and interwoven theories that link vaccines to autism. Researchers suggest that live viruses and the neurotoxins mercury and aluminum in some vaccines may be associated with neurological disorders (Jepson and Johnson, 2007)

Thanks for the laugh Gayle, however I’m none too happy with yet another exploding irony meter!

The co-managing director of Thoughtful House’s board is Jane Johnson of New York, part of the family of the Johnson & Johnson health care products and services company. Johnson (who co-authored Jepson’s book, Changing the Course of Autism) and her husband, Chris, donated $1 million to lay the groundwork for Thoughtful House in 2004
[Orac: Andrew Wakefield: “Pushed out by the board of directors at Thoughtful House?”]

Nope…no COIs for the Jepson and Johnson paper you cite. Honestly, what were you thinking Gayle?
ahhh…never mind.

One example in recent times would be UCSF

Matt, good thing the tobacco companies weren’t funding UCSF or this might never have come out.

there are still plenty of international studies, by both educational and research institutions that refute the vaccine / autism link.

Like the independent Statens Serum Institut

@ Sauceress:

Wouldn’t it be fun if anti-vaxxers were required to list their own COIs whenever they toss out that label ? Here are a few possibilities:
He / she: offers treatments for ASDs; sells supplements or special foods; writes a related blog/ book; offers medical services for anti-vaxxers; has patents on alternative vaccines and/ or treatments; gives lectures on the subject; has done research opposing the mainstream on vaccines/ autism; owes celebrity status to related blog, book, ASD; created group opposed to vaccines; has children/ grandchildren on the spectrum, offers legal services, is a friend of AJW etc.

Disclaimer: I have financial interests in pharma companies and ( gulp!) News Corp. Nothing big, mind you.

Like the independent Statens Serum Institut

Yes, like them. You know as much about the Danish system as you do vaccinology and infectious diseases I see.

I have financial interests in pharma companies and ( gulp!) News Corp. Nothing big, mind you.

Well I have no financial in Big Pharma. Hell I can’t even seem to earn a token shill cheque from Glaxxon PharmaCOM! In fact I’m convinced that all this filthy lucre from Glaxxon that some here wax lyrical about is nothing but an urban myth propagated to sucker in new shills!

I did however study pharmacology, immunology, microbiology, cell regulation, biochemistry and molecular biology as part of a biochem/molec bio degree. I’m sure that the antivaxx directors would have it that Big Pharma are funnelling money into universities conducting research in the relevant fields of study in order “assist” such research in reaching “right conclusions”.
The processes by which this eventuates are obviously kept a well guarded secret from the both the researchers themselves as well as those overseeing research ethics and protocols. Very sneaky indeed!

Oh dear…I may be a Big Pharma Shill after all. What’s embarrassing is that I’m an unpaid Big Pharma Shill!
Oh the SHAME!!

@ Sauceress: I too studied in college and, prior to coming to RI, I “shilled” for *Big Pharma*, working as a public health nurse. Those who work in the public sector for *Big Gubmint* are rewarded with crappy pens, by their overlords.

Now that I am a free agent, I find that the “compensation” is far more lucrative. Lord Draconis has been very generous to me http://krugerrandproof.com/

Let me know when you complete (in quadruplicate) your *Big Pharma Shill Application* and I shall forward a letter of recommendation to our esteemed and beneficent Lord Draconis.

Those who work in the public sector for *Big Gubmint* are rewarded with crappy pens, by their overlords.

You lie, madam! Sometimes we get coffee mugs, too.

Shay…let me add to my statement. When I worked for *Big Gubmint”, I was rewarded with crappy LEAKY pens.

“Sure, because Sid is such an expert in vaccinology and infectious diseases. What hubris.”

Science Mom, I suppose that if you can strike a match you, too, can be an expert in fire science.

“Matt, good thing the tobacco companies weren’t funding UCSF or this might never have come out.”

It was funded by NIH (national cancer institute). I’m sure there’s an explanation coming as to why the government and NIH can do acceptable research in this case but not for vaccines.

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