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Archive for June 2nd, 2011

Anti-vaccine warriors vs. research ethics

Three weeks ago, the anti-vaccine movement took a swing for the fences and, as usual, made a mighty whiff that produced a breeze easily felt in the bleachers. In brief, a crew of anti-vaccine lawyers headed by Mary Holland, co-author of Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children, published a highly touted (by Generation Rescue and other anti-vaccine groups, that is) “study” claiming to “prove” that the Vaccine Injury Compensation Program (VICP) had actually compensated children for autism. As is typical with such “studies” generated by the anti-vaccine movement, it was bad science, bad law, and just plain bad all around. The authors intentionally conflated “autism-like” symptoms with autism, trying to claim that children with neurological injury with “autism-like” symptoms actually have autism. Never mind that there are specific diagnostic criteria for autism and that, if the children actually had autism, many of them would have been given a diagnosis of autism. Never mind that what they were doing was akin to claiming that all patients with “Parkinson’s-like symptoms” have Parkinson’s disease. (Hint: They don’t.) Never mind that all they did was to demonstrate a prevalence of autism spectrum disorders among the VICP-compensated children that was clearly within the range of what would be anticipated if there were no relationship between vaccines and autism. Never mind all that. This was Holland’s big chance, but it went over like the proverbial lead balloon. No one bit, other than FOX News.

The study rapidly faded into the obscurity it so richly deserves, in spite of mighty efforts by Generation Rescue, SafeMinds, and the likes of Ginger Taylor to keep it alive and use it as a rallying point to persuade legislators to pass anti-vaccine-friendly legislation. You could feel the frustration in its backers as Holland’s study, into which groups like Generation Rescue had apparently poured their hopes of being vindicated, crashed and burned.

However, there’s one aspect of this study that I didn’t discuss. In fact, I thought of it as I read it, but I wasn’t sure. What I (and others) have noticed is that there was no statement in the article that approval had been obtained from the relevant institutional review boards (IRBs) to do human subjects research. For those not familiar with what an IRB is, an IRB is a committee that oversees all human subject research for an institution. It is the IRB’s responsibility to make sure that all studies are ethical in design and that they conform to all federal regulations. Basically, IRBs are charged with weighing the risks and benefits of proposed human subject research and making sure that

  1. risks are minimized and that the risk:benefit ratio, at least as well as it can be estimated, is very favorable;
  2. to minimize any pain, suffering or distress that might come about because of the experimental therapy; and
  3. to make sure that researchers obtain truly informed consent.

During the course of a study, regular reports must be made to the IRB, which can shut down any study in its institution if it has concerns about patient welfare.
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Posted in: Medical Ethics, Neuroscience/Mental Health, Public Health, Vaccines

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