• 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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    • I liked Paul Offit’s book on this topic. You are correct about the true anti-vaxxers. Nothing will shake their faith.

      Steve

    • Astounding but not suprising. The most shocking part to me is that he used 8 or 9 kids for a “study” or even an anecdotal story.

      How embarrasing for the Lancent; I mean I wouldn’t have published that on my personal blog just because it doesn’t pass the laugh test.

      I know the Lancent was always kind of looked down on by my physican friends I used to know years ago…maybe that’s why.

    • Thank you for sharing the details of the fraud. The major news organizations only touched on the claims but didn’t share details. That Wakefield’s ‘study’ ever got any press to begin with is shocking, and I really hope this puts the whole thing to rest…

      It probably won’t. I posted the NPR article on my Facebook page yesterday, and three mothers responded that they weren’t worried about autism; they’re worried about the other chemicals in vaccines. So, they just don’t vaccinate at all.

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

      I hope in some way, he’s shot.

    • this is nothing more than a self-indoctrinating peice of discreditation.

      Since when is discreditation proof-negative for any scientific question?

      If all you anti-anti-vaxxers feel : “You are correct about the true anti-vaxxers. Nothing will shake their faith.” Then it is more than obvious what the purporse of his book, AND who its expected audience is.

      $$$

      peace,
      you all keep injecting mercury into your infants and just cross your fingers ;)

      • Why is it that people can be so committed to something that is blatantly false? But doesn’t this just mirror today’s news environment where someone goes looking for people to say what they want to hear and then report it as truth? My opimism for the future is waning.

    • @mbzastava

      Yes, because clearly your gut instincts about what is good and bad for your child are far more finely honed than extensive scientific studies.

      Fingers will be crossed on your children’s behalf.

    • The proof-negative for vaccines being linked to autism comes in the form of the half-dozen or so very large, well-controlled epidemiological studies conducted in Europe over the past decade.

      I am all in favor of attempting to improve the safety of vaccines if there remain legitimate concerns. Indeed, thimerosal was removed from them in the last couple of years if I am not mistaken.

      Thus, “keep injecting your mercury into your infants” is nothing but an intellectually dishonest attempt to pigeonhole people who advocate for vaccination because they understand the critical medical role that vaccines play. Or in my case, indirectly know a family that chose not to vaccinate and had their child die.

    • “Not true. Some of us continued to educate ourselves and realized we were wrong to be anti-vax.” … “I still have not vaccinated my son because it’s hard to let go of the emotions I had about them.”

      So, your faith has been shaken but you *still* won’t vaccinate your child.

      Sounds to me like the original point stands. This was never a rational position, and has always been an emotional one – so reason will not change the behavior of the anti-vaxers.

    • “So, your faith has been shaken but you *still* won’t vaccinate your child.

      Sounds to me like the original point stands. This was never a rational position, and has always been an emotional one – so reason will not change the behavior of the anti-vaxers.”

      Noooo…. I wasn’t very clear. While there are still some questions and emotions involved in vaccinating for me, mostly we haven’t done it because it wasn’t *that* long ago that I changed my mind, and now my son’s too old to need the childhood vaccines *and* has gotten natural immunity to some of them – he had mild childhood cases of measles, pox, and pertussis – but not old enough to need them for sports, sexual activity, etc. We also haven’t had a doctor’s appt lately. This year we got the flu vaccine for the first time, since we were going to be around his new baby half-sister.

      I believe in vaccines, but that doesn’t mean I feel the need to run right out and re-arrange my schedules to make immediate appts with doctors when we’ll be going in later this year anyway.

    • I want to add, I think it’s entirely *rational* to want the best for your child, and to want to protect them from perceived dangers, even if your grounding in science is lacking.

    • Good luck with natural immunity to meningitis.

    • Sure, that’s one disease. But there are many more that the anti-vax community feels it can provide better protection through natural exposure/immunity.
      Y’know, some people are *selective* vaccinators, too. They pick the ones that are harder to “catch” naturally, or can be most severe if caught, and only vaccinate against those.

      Certainly, the way you all are so snottily dismissive of anti-vaxxers, it doesn’t make a person want to join your camp….. Even someone like me who is now in your camp you treat dismissively. Lovely company. Sort of a variation of “I refuse to join any club that would have me as a member.”

      Not that I feel any need to be welcomed by total strangers, just wanted to point out that anti-vaxxers can, in fact, return to science and change their minds. Sheesh.

    • “Mild childhood cases of measles, pox, and pertussis”? Seriously? How do you have a kid come down with whooping cough and not go straight out to take the ten minutes to start a vaccination program? Are you waiting until he gets mumps and you can claim a trifecta?

    • Seems to me that there is a bit of a free rider problem here. As long as the percentage of parents who do not vaccinate their kids is small, then non-vaccination may actually be rational because their kids have a low risk of catching a disease while they simultaneously avoid any potential vaccine side-effect. But if the percentage of non-vaccinators becomes large enough then plenty of these non-vaccinated kids will become ill and die as diseases begin to spread amongst the non-vaccinated..

      Thus, folks like Jenny McCarthy look down of parents who vaccinate their kids, but without these conscientious parents, all kids would be in a world of hurt.

    • This subject makes me unnaturally angry as well. In our area we have already experienced outbreaks of German Measles and Whooping Cough. So many children are not vaccinated that these kinds of outbreaks are just the first symptoms of an entire generation of children dangerously vulnerable to diseases that were once eradicated.

      No amount of proven science will convince these parents who do not vaccinate in their belief that they are doing the right thing for their children no matter what the effects of their decision are on the population. I personally know of a woman who lost her baby after coming in contact with a child who was not vaccinated, and unbeknown to the parents, sick with German Measles.

      I pity the future health of our children when parents discredit science and instead choose to believe in snake oil.

    • How about this theory:
      “anti-vacciners are mostly right and everyone who claims vaccines are safe is on payroll from medical companies”?

      Can you proove, pro-vaccine doctors, that your well-being does not depend on medical companies’ money?

      Would any big medical study about vaccines be conducted if not for medical companies’ money?

      Yes, I’ll have my kid vaccined. But only because I fear deadly diseases more than vaccines. The truth or science about vaccines died long ago.

    • “Can you proove, pro-vaccine doctors, that your well-being does not depend on medical companies’ money?

      Would any big medical study about vaccines be conducted if not for medical companies’ money?”

      It’s one thing to be anti-capitalist because there is something legitimately wrong with what a company does. But to bloviate a conspiracy theory based on anti-capitalist rhetoric makes you sound no different from the white trash teabaggers that run the United States right now.

      When a scientist presents a finding that is new and/or unprecedented as was seen in the now-retracted Lancet study, the first reaction of any scientist is to verify the information, possibly by conducting their own studies, attempting to repeat the conclusion for themselves. Not because there is some money to be had out of this, but to prove the finding for themselves. And why shouldn’t they? You easily forget that, thanks to vaccines, smallpox has been completely eradicated, polio has been isolated to 4 countries (all of whom (except maybe India) suffer from takfir dogma), and many debilitating diseases are no longer common in the world. That someone finds that a vaccine dedicated to preventing three of those debilitating diseases instigates something that parents claim to be a disease immediately raises scientists’ concern.

      You may be proud, parent. But pride always comes before destruction.

    • Let’s stop and think for a minute…so we don’t know if vaccines can harm our children or cause autism…let’s all just agree to disagree on that for now. What do we know about the diesease that our vaccinations prevent? THEY KILL OUR CHILDREN! So for those of you that feel that some of us our “taking our chances injecting mercury into our infants”…at least we’re taking our chances against some conspiracy that MAY (although extremely unlikely) cause our children to have developmental issues and not up against deadly disease.

      I think that if the MMR vaccine had failed and these diseases were still prominent in the US, many would gain an appreciation for what our medical professionals do. But since they’ve done such a good job over the past generations we’re now part of a spoiled and ungreatful nation that think we know better than the proffessionals that have spent hundreds of years doing their very best to protect our health.

    • Some of your readers may be interested in The Thinking Person’s Guide to Autism is a group blog edited by a team, all of whom reject the theory that vaccines are somehow causal in autism. Our post on the BMJ article revealing Wakefield’s fraud is http://thinkingautismguide.blogspot.com/2011/01/andrew-wakefield-yesterdays-british.html.

      I’ve added a link to this post in the comments.

    • The role of the lawyers in helping should not be ignored here.Their actions deserve to be called into question. Read the article…

      http://marketsandculture.blogspot.com/2011/01/mmr-vaccine-autism-andrew-wakefield-and.html

      ..it is astonishing how many millions of public money were wasted by their actions.

    • Here’s a little description of how cause & effect is established even when a study is not fraudulent.

      http://csiwodeadbodies.blogspot.com/2011/01/cause-effect-slip-slidin-away.html

    • Pediatricians lose money on every vaccine given, yet they still do it for the health of the child. I’ve seen children die from measles, chicken pox (it infected his heart), and pertussis. I also have a son with an autism spectrum disorder. If I had another baby, it would have all shots on time, because the diseases are far worse than we realize.

    • Measles and mumps rarely kill. I had both as a kid. We didn’t need vaccines for them in the first place. From what I have seen, more lives are affected negatively from the vaccines. Some are necessary, some are not. A mother should have a right to make an informed decision without feeling guilty about it. We don’t need a chickenpox vaccine, or a hep B shot right out of the womb. How can you think that the pharmaceutical companies are not taking advantage of people’s fear and ignorance. They are making millions. Trillions. Hello?

    • “Measles and mumps rarely kill.”
      Umm, excuse me? Maybe not directly, but measles and mumps can trigger illnesses that are lethal. Not to mention the fact that there is often scarring that remains long after the disease (and of course, the freakish appearance they often take during). Rubella maybe non-lethal as well, but you best not get it while pregnant, otherwise the kid will get a variation that can render them blind, deaf, and filled with heart defects (amongst a host of other serious diseases).

      “How can you think that the pharmaceutical companies are not taking advantage of people’s fear and ignorance. They are making millions. Trillions. Hello?”
      As are you. You are deliberately implying that autistics are nothing more than sick freaks that can’t take care of themselves and are a burden to parents, and thus represent a burden to society that it is better without. You may be playing a different set of cards, but you’re playing the same game.

    • So is that mean there is still no vaccine to cure autism. Is there any scientist who work on this and I if there is a vaccine surely I would like to buy no matter what is the cost.

    • What page is “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.” on?