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.

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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.

By Matthew Cline (not verified) on 05 Mar 2012 #permalink

âeven 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 itâ

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 donât 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.

By Antaeus Feldspar (not verified) on 06 Mar 2012 #permalink

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.

By Antaeus Feldspar (not verified) on 06 Mar 2012 #permalink

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.

By Broken Link (not verified) on 06 Mar 2012 #permalink

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.

By Denice Walter (not verified) on 06 Mar 2012 #permalink

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://scienceblogs.com/insolence/2007/09/a_bad_day_for_antivaccination…
http://scienceblogs.com/insolence/2008/01/sallie_bernard_responds_to_th…

Steve Novella also wrote a good commentary:

http://theness.com/neurologicablog/index.php/more-evidence-for-the-safe…

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).

By Denice Walter (not verified) on 06 Mar 2012 #permalink

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?

By herr doktor bimler (not verified) on 06 Mar 2012 #permalink

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.

By Dangerous Bacon (not verified) on 06 Mar 2012 #permalink

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?

By herr doktor bimler (not verified) on 06 Mar 2012 #permalink

"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 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.

By herr doktor bimler (not verified) on 06 Mar 2012 #permalink

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.

By Sauceress (not verified) on 06 Mar 2012 #permalink

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.

By herr doktor bimler (not verified) on 06 Mar 2012 #permalink

@ 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).

By Denice Walter (not verified) on 06 Mar 2012 #permalink

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:

http://www.ageofautism.com/2012/03/the-battle-to-defend-non-medical-vac…

Babs' article "mentions" COIs within the vaccine research community, and the efforts to eliminate "philosophical exemptions".

Why didn't you link to your recent posts on RI....on your "twitter" page and on your Facebook page, Offal?

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.

By herr doktor bimler (not verified) on 06 Mar 2012 #permalink

@ 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 Americaâs 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.

By Sauceress (not verified) on 06 Mar 2012 #permalink

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.

By Denice Walter (not verified) on 06 Mar 2012 #permalink

Offal...are you now referring to Robert Kennedy Jr's "masterpiece" about COIs within the science community?

http://www.scribd.com/doc/60166885/9/Undisclosed-Conflicts

Take a look at the footnotes Offal...he is using the *research* of Boyd Haley, Dr. and Baby Doc Geier, Dan Olmstead's *Amish Study*, Mark Blaxill and David Kirby.

You lose...again.

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!!

By Sauceress (not verified) on 06 Mar 2012 #permalink

@ 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.

Because the gov isn't in the tobacco business

By Phil Morris (not verified) on 06 Mar 2012 #permalink

@baglady, I'm going to have to make you president of my fan club considering what a dedicated follower you are. Be sure to check in on AoA this week. You might encounter a nice surprise. And when have I ever referenced RFK Jr.? Finally, in reference to the title of this piece, does Orac, by saying conflicts of interest in the vaccine game are exeggerated admit that there are in fact conflicts of interest?

By Sid Offit (not verified) on 06 Mar 2012 #permalink

When I worked for *Big Gubmint", I was rewarded with crappy LEAKY pens.

Aha...evidence that Big Gubmint is also in league with *Big Stain Remover and Big Uniform!!

*yeah...I've never managed to get hold of one that successfully removes ink either.

By Sauceress (not verified) on 06 Mar 2012 #permalink

@Offal

So you tell me, what is the Statens Serum Institute? How is it biased?

It's a part of the Danish Ministry of Health and works with the Danish Health System.

Is it the whole, 'omg socialism' schtick?

@ Darwy...Offal gets a lot of his *science* and a lot of his *conspiracy theories* from AofA. His reference to Statens Serum Institute is from this article:

http://www.ageofautism.com/2011/03/-danes-charge-cdc-linked-autism-rese…

Orac, in turn, critiqued the yellow journalism AoA article:

http://scienceblogs.com/insolence/2011/04/poul_thorsen_vaccines_fraud.p…

However...it might have something to do with his 'omg socialism' schtick or 'omg I'm a brainless twit who is clueless about science' schtick.

@Phil Morris,
Ever notice those tax stamps?

brian @ 74, Heh isn't that right.

Because the gov isn't in the tobacco business

And no one in government ever received large sums of tobacco monies in their election coffers. snort.

@Lilady

Aah yes - the 'vaccine manufacturer' Statens Serum Institute.

I see it now!

Or, I did earlier today when I was there. Funny how a public enterprise under the auspices of the Danish Ministry of Health (and linked with the Danish Health Registry for monitoring of diseases, etc) is just a 'vaccine manufacturer' or 'big pharma'.

Prometheus: I made it up. It makes sense to me that an antigenic response can be typical, and overcome, by a typical immune system. In an immune system that is somewhat abberant a person could have an atypical response. I was thinking cascade was a scientific term regarding immune response, ie, a point of no return once a certain degree of response was reached.

My son had a HHE (Hypotonic Hyporesponsive Episode) at age 2 months, coming home from the health office with his DPT shot. At the time, I couldn't have brought a legal proceeding to the NVICP, had I known it existed before my son turned 7 years old (note, one has 3 years from date of shot to petition the NVICP regarding damages.) It lasted less than 24 hours. The next morning he seemed fine.

I was so afraid of being one of those crazy people who believe vaccines damage their kids, I didn't even take him to the doctor. Maybe that's where my guilt lies. I thought it was a mild seizure. Ended up it was a brain swelling. I didn't know and feel like an idiot confessing now. I prayed he wouldn't die.

"Sciency" people have told me it was a coincidence, correlation does not equal causation, to which I think, "the hell it don't". Or I have been told that my son isn't special, and everyone has to take it in the chops for the good of the herd. Yeah, let's see you do it for your kid if you were in the same situation.

I don't belong to any group of anti-vaxers, and I tend to think for myself. You can't put me in a corner with one of your pre-prepared arguments.

My son had a brain swelling. Why? His pediatrician said it was probably the Pertussis. There was a bad batch that year...it became acellular the next after like 14,000 complaints to the NVICP. Also, if I could afford genetic testing, I could figure out if my son had inherited Tuberous Sclerosis from his birth parents, one genetic cause of autism. A severe responsse to the DPT is often how it is discovered early.Y'all could chip in and help, if you'd like. Ten years ago it was $3500 and not covered by insurance. Probably $10,000 today.

But to hear you, all parents whose children seem to have had a reaction to vaccines are crazy. I think there is a very real possibility that science hasn't caught up with reasons why some children need special regard when it comes to vaccines.

No day is a good day for a brain-swelling.

Dearest Sauceress,

Your saucery is excellent. You should be aware that new minions and shills are not paid immediately: this is purely to test your loyalty- for those who grumble aren't regarded most fondly by the powers-that-be ( and you *do* realise who that is!) So hold your horses.

Because I - unlike his scaly magnificence- actually have a heart, I myself will send you something- probably an extremely over-priced purse and a couple of items from Burberry- for g-d's sake, we're agents of inter-galactic oppression and commerce we can't go around looking like we work for the airlines! I hope you enjoy your cache. Have a nice day!

Sincerely
DW, DL-8 et al

"And no one in government ever received large sums of tobacco monies in their election coffers. snort."

Nor do they tax Tobacco...

One thing I noticed in the article by DeLong is that although she claims to acknowledge the COI's in advocacy groups (narrowly defined, btw), she doesn't spend a lot of time on the restrictions which should be placed on them or individuals with COI's.

As to the "narrowly defined" statement above--she only considers groups such as SafeMinds, NVIC, and other vaccine-skeptic orgs as "advocacy groups". Groups such as the Gates Foundation, Every Child by Two, the advocacy centers at Vanderbildt and Johns Hopkins are not included as "advocacy groups".

@Matt Carey

As to the "narrowly defined" statement above--she only considers groups such as SafeMinds, NVIC, and other vaccine-skeptic orgs as "advocacy groups". Groups such as the Gates Foundation, Every Child by Two, the advocacy centers at Vanderbildt and Johns Hopkins are not included as "advocacy groups".

That's because those are just fronts for the vaccine manufacturers, natch. Likewise, Autism Science Foundation is not an autism research advocacy group. No. The ASF is merely an extension of the Glaxxon PharmaCOM hegemony.

Let me see if I got this right:

Dr. DeLong thinks that someone who is paid to investigate the safety of a vaccine as one project in a career's worth of research, each research project being funded by different sources (private institutions, industry, government, etc.) has a serious conflict of interest, yet someone whose full-time job is to "generate information to refute [federal health] agency or [vaccine] industry claims" does not, because the vaccine research - as a whole - spends more money than the "antivaccine advocacy" groups?

Is she really this dense?

A researcher investigating vaccine safety will have to apply for other funding in the future - maybe next year, maybe tomorrow - and the one sure-fire (and proven) way to permanently end a research career is to "fudge" the data (ask Andrew Wakefield).

On the other hand, someone with a doctorate in international business who works to "generate information to refute agency or industry claims" isn't likely to ruin their academic or business career by making claims that can't be supported or (as in her previous paper on vaccines) deliberately skewing the data to favour the organisation funding her.

The inescapable fact is that everyone has "conflicts of interest" large and small, no matter what they do. What's at issue (and is carefully concealed by Dr. DeLong's paper) is that the researchers investigating vaccines have a much less significant conflict of interest that the people opposing vaccines.

Prometheus

UK Telegraph:

http://www.telegraph.co.uk/health/children_shealth/9128147/MMR-doctor-w…

"The judge said the GMC fitness to practise panel's conclusion that Prof Walker-Smith was guilty of serious professional misconduct was flawed in two respects.

There had been "inadequate and superficial reasoning and, in a number of instances, a wrong conclusion".

The decision to strike off had been defended at a recent hearing as "just and fair â not wrong" by Joanna Glynn QC, appearing for the GMC.

She said: "In spite of inadequate reasons it is quite clear on overwhelming evidence that the charges are made out."

But the judge disagreed and said the misconduct finding and the sanction of erasure â striking off â "are both quashed"

That High Court judge is a skeptic's skeptic. I give him credit for that.

Now, what?

By Proscientifica (not verified) on 07 Mar 2012 #permalink

@ Proscientifica: "Now, what?"

Is that a rhetorical question? What do you think the ramifications of the Walker-Smith's license reinstatement will be. (I had previously stated on RI that no matter how the judicial review turns out for W-S...it has no bearing on the Andrew Wakefield GMC ruling that "struck AJW from the register".)

And even less relevance than that for what's actually true. Wankerfield committed gross fraud, the conclusions he claimed to draw from his made-up data were completely wrong, and that's pretty much all there is to say.

I'm more interested in the Walker-Smith saga at the moment.
Does the "quashing" change reality?
GMC reality is/was Walker-Smith not proper or fit to have UK medical license. Mittig inhabits a different reality where his review of the evidence demonstrates that Walker-Smith is qualified to hold license.
These world views are in conflict, yet are seemingly based in the same set of "facts."
How can the two opposing interpretations exist side by by side? Is it not appropriate to speculate on "who got it correct"- GMC or Mittig?

By Proscientifica (not verified) on 07 Mar 2012 #permalink

@ lilady:
@ Beamup:

I OT'ed about JW-S @ the Burzynski post this am and commented @ Sullivan's blog; unfortunately, a Mr Handley and friend didn't like it. Oh well, I guess my finely wrought prose, impeccable skills and sparkling personality aren't pleasing to everyone. *Quel dommage* I also responded.

By Denice Walter (not verified) on 07 Mar 2012 #permalink

@lilady-

you write "(I had previously stated on RI that no matter how the judicial review turns out for W-S...it has no bearing on the Andrew Wakefield GMC ruling that "struck AJW from the register".)

I am respectfully skeptical (though trying hard not to be insolent) regarding your view.

Having read the judge's decision, he has bought into the argument that the children were treated on the basis of clinical need, not used for experimentation. He goes through almost each child's referral process, history, and treatment. He discusses the ethical guidelines that were invoked to do various procedures.

If the children were treated based on clinical need, yes, I do believe that is relevant to Wakefield, if anyone cares.

The judge would seem to be highly skeptical of the construct that suggests the children were the victims of unnecessary, invasive medical procedures, which I understand is the main and most serious charge against the other doctors involved, including of course Wakefield.

By Proscientifica (not verified) on 07 Mar 2012 #permalink

@prometheus: I was thinking I got it from Polly Matzinger, and it turns out it's probably so. Here is one example: There is a cascade response of immunological cells to chemo-induced necrosis of tumor cells. The dying tissue release ATP as they expire, which sets off a dendretic cell receptor, cause a secretion of 1 beta interleukin which primed CD8+ cells to find and kill further cancer cells. This is just one example of a cascade I googled here--http://jnci.oxfordjournals.org/content/102/2/76.full.pdf

I studied her life because she is a woman and way atypical and probably correct in her danger theory of immune response. It's six of one, half a dozen of another as most science is until somebody figures out the present "truth". She's also really nice.

I believe we may one day find that vaccines are the modern answer to penicillin. You CAN have too much of a good thing, and some people just can't handle them.

I am a rather pissy old fart when it comes to vaccines. The HHE at 2 months following a DPT was not a "correlation does not equal causation" bit, and although I think my son's problems are probably genetic or environmentally induced because of an anomaly ... I've never quite "let go" of that serious response to vaccination. His brain swelled, and it couldn't have been good, ya know?

Finally, in reference to the title of this piece, does Orac, by saying conflicts of interest in the vaccine game are exeggerated admit that there are in fact conflicts of interest?

If you look hard enough, and are conspiracy-minded enough, you can see "conflicts of interest" everywhere. If Fireman Mike visits the grammar school to tell kids about fire safety and how to prevent fires, a sensible person doesn't see a conflict of interest there. An idiot, however, says "ZOMG! He is both advising how to supposedly prevent fires and getting paid to put fires out! Conflict of interest!! His advice on how to prevent fires must be subtly designed to cause fires instead!"

If AoAers were truly so concerned about COIs they'd look for the COIs of antivax advocates just as intensely as they do the purported COIs of vaccine advocates, but as we all know that doesn't happen. The fact that Andrew Wakefield was being paid by lawyers specifically to generate evidence against the MMR vaccine, and had a patent on a product that he himself declared would be more profitable if public confidence in MMR was damaged? Nope, no COI there! Oh, but that team of researchers that studied an alleged correlation between vaccines and neurological disorders and found that said correlation didn't stand up to scrutiny? Well, it just so happens that those researchers were working for the CDC! Which of course is part of Big Government, which of course must be in cahoots with Big Pharma because they both have "Big" in their names! ZOMG COI!!!

By Antaeus Feldspar (not verified) on 07 Mar 2012 #permalink

Having read the judge's decision, he has bought into the argument that the children were treated on the basis of clinical need, not used for experimentation.

No, he has bought into the argument that they may have been treated on the basis of clinical need, but that the panel failed to justify it's reasoning that the argument is false. In fact, the judge indicates that he didn't remit to the panel for a new hearing because the GMC said "Don't bother." Why would the GMC say this? Because Walker-Smith has retired and is no longer practicing medicine. It would be a waste of resources to hold hearings to strike off a retired doctor.

@ W. Kevin Vicklund-

wasn't he (walker-Smith) retired when the hearings started?

By Proscientifica (not verified) on 07 Mar 2012 #permalink

@ Denice Walter: I've just posted a comment on LB/RB about the Walker-Smith court decision...you're going to enjoy it.

@ Proscientifica: I also read the decision and I think that Walker-Smith prevailed because he was able to argue that he was (somewhat) an innocent bystander to what Wakefield was doing "behind the scene" to find some "positive" findings of enterocolitis caused by the MMR jab...the basis of the proposed lawsuit instututed by the attorneys who already had Wakefield on the payroll...as their hired gun expert witness.

Apparently, according to the Judge's decision, W-S was able to convince the court that the colonoscopies did not constitute "serious medical misconduct"...the court did not exonerate him and did not address the issue of "medical misconduct". The GMC decision to strike W-S from the register was based on "serious medical misconduct"...once the court opined that W-S did not commit "serious medical misconduct"...the GMC decision was "quashed".

Each of the cases against each of the doctors was judged separately by the GMC and should have been appealed by the individual doctors. W-S appealed his decision...and Wakefield did not.

Be sure to check in on AoA this week. You might encounter a nice surprise.

The only thing that would surprise me from that blog is an accurate portrayal of a scientific finding. If that ever gets posted, I'll eat my hat.

Reuben:

"The only thing that would surprise me from that blog is an accurate portrayal of a scientific finding. If that ever gets posted, I'll eat my hat."

And, I'll eat your other hat...in Macy's window with a spotlight on me.

Poor Offal, still a believer, still delusional and still with a misplaced inflated opinion of his science competence.

wasn't he (walker-Smith) retired when the hearings started?

Wakefield and Murch weren't, and there was a lot of overlap, so it made sense to include him at the time. Also, I think he was still doing some side work at the time, but I'm not sure on that.

@Darwy

So you tell me, what is the Statens Serum Institute? How is it biased?

Good one Darwy! I thought you were serious for a minute

the institute also develops and produces vaccines,

By Sid Offit (not verified) on 07 Mar 2012 #permalink

@Sid

So? You have yet to make the case that the SSI is biased. Yes, part of the operation of this Danish public institution develops and produces vaccines. How does that make them biased? They are not a for-profit institution so you can't claim a financial motive.

By Niche Geek (not verified) on 07 Mar 2012 #permalink

Sid, you have forgotten that the Statens Serum Institute is a government agency and therefore (by definition) *inefficient*.
If it were in the private sector, one would expect efficiency from it, and single-mindedness, and proper incentives; it would have only one purpose -- to develop and produce vaccines -- and the careers of its employees would depend on how well they advanced that purpose.

As it is, however, the SSI serves multiple functions, with sections devoted to vaccine procurement, and other sections to testing vaccine safety; and due to this inefficiency, if the safety people were to link some vaccine to serious health hazards, no-one has any obvious incentive to suppress that information.

IIRC, Orac published a post from a Danish guest-blogger back in 2005 about the legal structure governing the SSI. In particular, the guest blogger reckoned that the SSI could *not* be sued for negligence if one of the vaccines it had been tasked to distribute later proved to be injurious... that is, one putative bias towards exaggerating safety and concealing a side-effect was in fact not present.

By herr doktor bimler (not verified) on 07 Mar 2012 #permalink

@ Sid

The Statens Serum Institute is a public enterprise; vaccines are but a small part of what the Institute is responsible for. It has a first class research & development center, it oversees the health of the Danish people through surveillance, etc. It also has an excellent reference laboratory available for testing a myriad of cultures, strains and spores.

"Big Pharma" it ain't.

it oversees the health of the Danish people through surveillance

SCARY WORD! Now you have conjured up mental images of a CCTV camera on every street corner in Copenhagen looking for the first sneeze or sniffle...

By herr doktor bimler (not verified) on 08 Mar 2012 #permalink

@Herr Doktor

Not every street corner.

Only every third corner.

And the train stations. Nørreport and Ãsterport especially.

Only every third corner.
And the train stations. Nørreport and Ãsterport especially.

I hope they scan every traveller in infra-red to detect anyone running a fever!

By herr doktor bimler (not verified) on 08 Mar 2012 #permalink

Shh.

That's called the 'rejsekort'. You're supposed to 'check in' and 'check out' of the buses and trains.

/nods

Apoptosis Cascades....brought to me by passionlessdrone, another idiot parent who doesn't blindly buy the science, but looks at all sides.

"Drones" blogpost here http://passionlessdrone.wordpress.com/2012/03/09/considering-the-scaffo… and mention of this: apoptosis cascades (for review, see Hehlgans and Pfeffer, 2005) leads one to this page:http://passionlessdrone.wordpress.com/2012/03/09/considering-the-scaffo…

Wonder which one of you smart boys could give me a synopsis of either paper. They are beyond me, but "Drone" often comes up with something important. I would be especially interested in TNF and it's tie in to Tuberous Sclerosis.