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.