• The Autism/MMR Fraud

    Yes, fraud.  Strap in, cause this one will be a ride.

    From my book:

    The myth that vaccines cause autism began in 1998, when an article was published in The Lancet that followed the cases of twelve children with developmental regression and gastrointestinal symptoms, such as diarrhea or stomach pain.  Nine of those children had autism, and eight of the nine had parents who thought the symptoms of autism developed after the vaccine for measles, mumps, and rubella (MMR) was administered.  This was not a randomized, controlled trial, nor even a scientific study.  It was merely a description of a small group of children.  To be honest, it’s difficult to imagine such a study getting published in The Lancet today.  Based on the beliefs of those eight parents, a frenzy of fear about vaccines and autism has ensued for the past decade.  Moreover, these concerns about autism and vaccines are only heightened by a timing issue.  Remember, humans try to make sense of the world by seeing patterns.  When they see a disease that tends to appear around the time a child is a year or so old (as autism does) and that is also the age that children get particular shots, our human brains want to put those things together.  But just because two things happen at the same time, one does not cause the other.  This is why we need careful, scientific studies to answer important questions like this.  There have been many such studies in the last decade that have contradicted the hypothesis that vaccines cause autism.

    The lead author of that Lancet study was Andrew Wakefield, who has become a cause celebre for speaking truth to power about the link between the MMR vaccine and autism.  It doesn’t matter that many, many and much, much larger studies could not find a link.  He had all the proof anyone needed.

    And then cracks appeared in his story. From the end of my book:

    Remember, this controversy all started ten years ago with a paper describing the beliefs of parents of eight children with autism.  Since that time, ten of the twelve authors of that paper have publicly and professionally retracted from the original paper the supposition that MMR could cause autism; this is a rare occurrence in the medical literature.  An eleventh author could not be contacted before the release of the retraction in 2004.  And the final author, who was the lead author of the original study, was investigated earlier this year for ethical violations and undisclosed conflicts of interest in conducting that original research.

    Imagine how different the world would have been if that one small study hadn’t been published.

    That was a few years ago.

    Today, just now, the BMJ released an article by Brian Deer that describes, in detail, how Wakefield’s entire paper wasn’t just junk science – it was a lie.  He changed the records, he changed the stories, and he changed the numbers to create an association where none existed.  Mr. Deer seems to have tracked down every single patient in the study and showed  how none of their stories or information match up to the final paper. In an accompanying editorial in the BMJ, the editors say:

    The Office of Research Integrity in the United States defines fraud as fabrication, falsification, or plagiarism. Deer unearthed clear evidence of falsification. He found that not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration, and that in no single case could the medical records be fully reconciled with the descriptions, diagnoses, or histories published in the journal.

    Who perpetrated this fraud? There is no doubt that it was Wakefield. Is it possible that he was wrong, but not dishonest: that he was so incompetent that he was unable to fairly describe the project, or to report even one of the 12 children’s cases accurately? No. A great deal of thought and effort must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction; misreporting was gross. Moreover, although the scale of the GMC’s 217 day hearing precluded additional charges focused directly on the fraud, the panel found him guilty of dishonesty concerning the study’s admissions criteria, its funding by the Legal Aid Board, and his statements about it afterwards.

    Furthermore, Wakefield has been given ample opportunity either to replicate the paper’s findings, or to say he was mistaken. He has declined to do either. He refused to join 10 of his coauthors in retracting the paper’s interpretation in 2004, and has repeatedly denied doing anything wrong at all. Instead, although now disgraced and stripped of his clinical and academic credentials, he continues to push his views.

    How bad was the deception?

    First of all, in order for this all to make sense, the children had to have what is known as “regressive autism”.  In other words, they had to have been fine – normal, in fact – and then get much worse after the MMR shot, developing autism.  Children who obviously weren’t right from the start would have had something wrong already, and not have autism caused by the MMR vaccine.  In Wakefield’s paper, he described 9 of the 12 children as having regressive autism.  Mr. Deer’s investigation found that three of the 9 children he reported as regressive autism were not.  Moreover, an additional 5 of the remaining 6 could not be proven to have regressive autism.  So – at best – only 6 of the 12 children in the study had regressive autism; more likely, only one did.

    Next, Wakefield’s paper alleged that a colitis brought on by the vaccine is what led the shot to become so damaging.  In his paper, he reported that 11 of 12 of the children had a nonspecific colitis. What did the records show?  That only 3 of the 12 had nonspecific colitis.  The other 6 cases were falsified.

    And, of course, the final piece of the puzzle was that symptoms needed to start not long after the vaccine was given.  In Wakefield’s paper, 8 of the 12 patients reported symptoms days after the MMR. Mr. Deer’s investigation confirmed that for 10 of the 12 children, this was false.  For the other two it was unknown.  So – at best – 2 of the 12 children showed symptoms near the vaccine.  At worst, none did.

    How many children had all three features according to Mr. Deer’s investigation?  None.

    None.

    The summary of Mr. Deer’s findings:

    The Lancet paper was a case series of 12 child patients; it reported a proposed “new syndrome” of enterocolitis and regressive autism and associated this with MMR as an “apparent precipitating event.” But in fact:

    • Three of nine children reported with regressive autism did not have autism diagnosed at all. Only one child clearly had regressive autism

    • Despite the paper claiming that all 12 children were “previously normal,” five had documented pre-existing developmental concerns

    • Some children were reported to have experienced first behavioural symptoms within days of MMR, but the records documented these as starting some months after vaccination

    • In nine cases, unremarkable colonic histopathology results—noting no or minimal fluctuations in inflammatory cell populations—were changed after a medical school “research review” to “non-specific colitis”

    • The parents of eight children were reported as blaming MMR, but 11 families made this allegation at the hospital. The exclusion of three allegations—all giving times to onset of problems in months—helped to create the appearance of a 14 day temporal link
    • Patients were recruited through anti-MMR campaigners, and the study was commissioned and funded for planned litigation

    I have become so cynical about people’s loss of trust and understanding in science that I think it’s likely this will do nothing to convince many people that the MMR vaccine is safe. That’s a tragedy in itself.  I’ve also become so cynical about this issue that I think Wakefield will probably not suffer the repercussions he deserves; many will still continue to lionize him and believe him to be a victim of some powerful cabal.

    This makes me unnaturaly angry.  It’s hard for me to be dispassionate about people who abuse the trust people give physicians; I get even more riled up when someone violates the rules of ethical science.  I think it’s likely that children have not been given the MMR because of Andrew Wakefield’s fraud.  I think it’s likely children have gotten sick because of Andrew Wakefield’s fraud.

    I think it’s likely children have died. I hope in some way, he feels it.

    ______________

    Extracted material from DON’T SWALLOW YOUR GUM! by Aaron Carroll, MD and Rachel Vreeman, MD copyright © 2009 by the author and reprinted with permission from St. Martin’s Griffin, an imprint of St. Martin’s Press, LLC

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