To the End of Reckoning

It is not a shining moment for science or for law. 

Indeed, the story reads more like a gripping thriller — one that the reader finally sets down by the side of the bed at 3 AM thinking that it was an exciting enough tale to forgo sleep even if it was totally unbelievable.  Imagine the plot summary.  A physician, receiving handsome payments from an attorney who wants to bring a class-action suit against a vaccine manufacturer, invents a fictional disorder and fabricates data to establish a fraudulent link with the vaccine.  The stuff of Ian Fleming or John Le Carre. 

In 1998, Andrew Wakefield and twelve other others published a paper in Lancet, a prestigious medical journal, implying a link between the measles, mumps, and rubella (“MMR”) vaccine and a new syndrome of autism and bowel disease.  Many scientists were skeptical, pointing to any number of scientific weaknesses in what was reported.  But large segments of the public relied on the paper when its findings were reported in the general press.  Vaccination rates plummeted as parents determined that the risk of autism in their children was too great.  The inoculation rate dropped most dramatically in Britain, from about 92% to below 80%, but many children in other parts of the world also failed to receive the MMR vaccine as a direct consequence of the Wakefield paper.  From having been declared “under control” in the mid 1990’s in Britain, measles was declared “endemic” in Britain only ten years after publication.  The U.S. Centers for Disease Control notes that more cases of measles were reported in the United States in 2008 than in any year since before publication, with more that 90% of those having not been vaccinated (or having a vaccination status that was unknown). 

A series of articles being published in the British Medical Journal  began last week, exposing a fraud surrounding the paper that author Brian Deer likens to the Piltdown Man scandal, an elaborate hoax that disrupted the natural course of paleontology research and that took decades to uncover.  I briefly discussed Piltdown man some months ago here.   Deer describes how Wakefield was retained by attorney Richard Barr two years before the paper was published, and paid more than £435,000, six times his annual salary as a physician.  The children in the “study” that he conducted on MMR were targeted and preselected to have desired symptoms, he reinterpreted clinical records to suit his contrived syndrome, and “chiseled” histories to reach unsupported clinical diagnoses.  While admonishing many who failed to exercise sufficient diligence — coauthors, fellow scientists, hospital managers, journal editors — Deer reports that the evidence shows it was Wakefield alone who perpetrated the scandal and that not even the attorney who paid him knew what he was doing. 

When Deer first reported on irregularities surrounding the study in 2004, ten of Wakefield’s coauthors retracted the interpretation.  In January 2010, a five-member tribunal of the British General Medical Council found dozens of allegations of misconduct proved, including four counts of dishonesty and twelve involving the abuse of developmentally challenged children.  A copy of the results of the Fitness to Practise Hearing, which was the longest ever conducted by the Council, can be found here.  

The consequences of the misconduct are truly staggering.  Epidemiological studies were conducted at great public expense, unable to confirm any link between autism and the MMR vaccine.  Research funds and personnel were diverted from more legitimate avenues to understand the actual causes of autism and to help those affected by it.  Many children who might otherwise have been vaccinated suffered an illness that we have the technology to prevent and may be among the small number who died as a result of having contracted measles.  At the moment, the effect on mumps contraction remains unclear because its peak prevalence is in older adolescents. 

In its editorial, the British Medical Journal pulls no punches.  It asks whether it is possible that Wakefield was wrong but not dishonest.  After all, scientists are allowed to be wrong.  Indeed, it is a strength of the scientific method that all honest ideas should be considered so that they can be scrutinized and dismissed if they are incorrect. 

The answer it gives is a simple one:  “No.” 

Not a single one of the case studies was reported accurately.  The pattern of the misreporting shows an intent to mislead.  Already actions are being taken to examine Wakefield’s other publications, mindful of the experience that misconduct is rarely an isolated event. 

When I write about various issues on this blog, one of the things that I am reminded of repeatedly are the similar ethical requirements that attorneys and scientists are expected to adhere to.  Those ethical requirements exist because of the importance of the work that they do, and the trust that is necessarily placed in them by the public. 

Attorneys suffer a great deal from distrust by the public, and I have always thought that that is one of the prices to be paid for the system.  Attorneys deal with controversies between parties that have opposing interests and operate in a system that requires that the best arguments be put forward on behalf of their clients, most especially for those clients who seem unlikeable and potentially subject to victimization if the state or other opposing party is not held to the strictest standards of proof. 

Scientists have generally enjoyed a more favorable reputation by the public, but misconduct of this scale has repercussions that extend far beyond even vaccines and autism.  Such acts of misconduct erode public confidence in the legitimate conclusions of science, putting members of the public in a circumstance where they do not know who or what to believe.  They are inconsistent with the openness that is the very bedrock of science, which seeks to communicate not only what we do know but also what we don’t.  Because if people are to make decisions in their lives based on the results that science achieves, they deserve to know both.

About Patrick Boucher

The author, Patrick M. Boucher, is a patent attorney living near Denver, Colorado and working at Marsh Fischmann & Breyfogle. He holds a Ph.D. in physics as well as a J.D. He is an active member of the American Physical Society, and is admitted to practice law in the states of Colorado and New York, as well as to practice before the U.S. Patent and Trademark Office. He is also a member of the Authors Guild and of the Colorado Authors League.

  • Jason

    Pat, thanks for this history. We discussed this a lot of the holidays. I have a good friend that ascribes to the defunct theory that vaccinations lead to autism. They continue to hold this belief even when two of their un-vaccinated children have Asperger’s Syndrome (a mild form of autism). It goes to show that wanting something to be true is stronger motivation than the facts.

  • Patrick Boucher

    Thank you for the comment, Jason. I agree – many people are naturally driven to know the reason that something happens so that they can do something to try to prevent it. Unfortunately there are still many cases, like the majority of autism cases, where no one yet really knows.

  • http://lizditz.typepad.com Liz Ditz

    Dear Mr. Boucher:

    I’m keeping a list of positive responses to the BMJ (Yes Wakefield is a fraud, and here are the implications…) and negative responses (Wakefield’s research IS TOO valid and vaccines cause autism anyway) at A roundup of responses to the BJM & Wakefield’s research was motivated by fraud.

    Some observations
    1. The positive responses come from a broad range of sites — politically left and right; people who are skeptics/ people who have heretofore (to my knowledge) never commented on vaccines or autism before, and so on. The negative responses are from a predictable set of sites and people.
    2. The news coverage in the US has (perhaps inadvertently) perpetrated the idea that all parents of children with autism believe in the vaccine causation myth. It is a complete falsehood. Many parents of children with autism and adults with autism robustly reject the myth.
    3. Kev Leitch, whose daughter has intense autism, has a moving post on how Wakefield’s actions have damaged everyone affected by autism

    I can hope that the Wakefield debacle will cause parents to be more skeptical but I think that hope is in vain.

  • Patrick Boucher

    Ms Ditz,

    Thank you very much for your helpful and informative comment. The links you provide seem very useful for people interested in obtaining more information about the issue.

    Patrick

  • Ted Weverka

    Is Wakefield legally liable for the consequences? I can imagine there could be both civil and criminal liabilities for the damages his actions have caused.

  • Patrick Boucher

    There may indeed be both civil and criminal liability. The usual approach to bringing actions against researchers who engage in misconduct is through the federal False Claims Act, which sets forth liability for those who make false statements to the government as part of a claim for payment. Frequently researchers who engage in misconduct make false statements in grant applications, and those statements provide a mechanism for action. The False Claims Act allows for both civil and criminal penalties. The best known eample is probably Eric Poehlman, who published fabricated research for hormone replacement injections as a therapy for menopause, and was sentenced to a year’s imprisonment as a result of his misconduct. There are other examples also. Stephen Bruening, for instance, was sentenced to 60 days imprisonment for falsifying research related to the use of ritalin. Although it was eventually overturned, the case of Pamela Berge is also interesting — the University of Alabama was at one time ordered to pay her $1.9 million when she alleged that researchers included her doctoral work as part of a grant application without attribution.

    Wakefield’s research was mostly conducted in the United Kingdom, and I am less familiar with the law there, but I expect that there are comparable provisons to the False Claims Act in effect. Use of the False Claims Act in the U.S. in instances of scientific miscoduct seem to have been increasing.