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The General Medical Council to Andrew Wakefield: “The panel is satisfied that your conduct was irresponsible and dishonest”

BACKGROUND

In my not-so-humble opinion, the very kindest thing that can be said about Andrew Wakefield is that he is utterly incompetent as a scientist. After all, it’s been proven time and time again that his unethical and scientifically incompetent “study” that was published in The Lancet in 1999 claiming to find a correlation between vaccination with MMR and autistic regression in autistic children with bowel symptoms was at best dubious science and at worst fraudulent. For one thing, as investigative journalist Brian Deer found, Wakefield was in the pocket of trial lawyers, who were interested in suing vaccine manufacturers, to the tune of £435,643 in fees, plus £3,910 expenses beginning even before his infamous “study” started accruing patients. Even though the study itself used the typical careful and relatively neutral language that we all expect from scientists, Wakefield himself was not nearly so circumspect. In a press conference announcing the Lancet study, he said:

He told journalists it was a “moral issue” and he could no longer support the continued use of the three-in-one jab for measles, mumps and rubella.

“Urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people,” Dr Wakefield said at the time.

And so began one of the most contentious health stories of this generation.

Wakefield’s Lancet paper, even interpreted as sympathetically as possible, concluded nothing that justified such language. Yet his rhetoric, along with sensationalistic and credulous British journalists, ignited a firestorm of fear over the MMR that has not yet subsided now, over a decade later. Vaccination rates plummeted in the UK, and measles, a disease once thought to be under control, has surged back and become endemic again. It is a feat that Jenny McCarthy and Jim Carrey appear to be trying to replicate right here in the U.S. with their wonderfully Orwellian-named Green Our Vaccines activism and ceaseless promotion of anti-vaccine messages.

More recently, at the Autism Omnibus hearings, we learned from a world expert in the polymerase chain reaction, Dr Stephen Bustin, that the techniques used in the laboratory running PCR on the clinical specimens from Wakefield’s clinical trial were so shoddy, so devoid of routine controls necessary in any PCR experiment, that the measles sequences reported as amplified in Wakefield’s followup to his Lancet study were false positives derived from plasmids with measles sequences in them contaminating the laboratory. Then, in late 2008, Mady Hornig and colleagues at Columbia University published an attempted replication of Wakefield’s study. They failed. There was no association between vaccination with MMR and autistic regression, nor could Hornig find any evidence that measles in the gut was any more common in the autistic children studied than in the neurotypical controls. This study was particularly devastating to Wakefield because it was carried out by a researcher who had previously been sympathetic to the myth that vaccines cause autism, as evidenced by her infamous “rain mouse” study and, even more close to home, using the same laboratory that had performed Wakefield’s PCR, which had apparently cleaned up its act in the years following its work on Wakefield’s specimens.

When it comes to the science, there is no doubt. No reputable scientist has been able to replicate Wakefield’s findings, and there is a remarkable convergence and agreement of findings of major studies looking for a correlation between MMR vaccination and autism: There ain’t one. Indeed, closing out 2009 was the publication of yet another study that failed to find any correlation between MMR and autism, or, as I put it at the time, yet another nail in the coffin of the myth that the MMR vaccine causes autism. Andrew Wakefield’s repeated claims that the MMR can cause or “trigger” autism in some children is deader than dead as a scientific hypothesis and without a basis in scientific or clinical evidence. True, Wakefield tried to counter with a horribly unethical and badly designed primate study that seemed custom-designed to be used in court rather than in the court of scientific inquiry. It didn’t help and only made Wakefield’s Thoughtful House, Wakefield’s Fortress of Solitude in Texas to which he retreated in the wake of the revelations about his conduct, look even worse. Even a credulously “balanced” TV story by NBC news and Matt Lauer couldn’t hide the dubiousness nature of what goes on there.

Of course, while the science refuting Wakefield’s pseudoscience and evidence showing Wakefield to be incompetent and unethical continued to roll in, a little less than a year ago, it got even worse for him. Brian Deer reported that Wakefield very well may have engaged in scientific fraud in the “research” (and I do use the term loosely) that led to the publication of his Lancet paper in 1999. Through it all, the General Medical Council began an inquiry into whether Andrew Wakefield behaved unethically in the “research” that resulted in his 1999 Lancet report. It should be pointed out that the investigation of the GMC began before Deer’s latest revelation of potential fraud; rather it was far more concerned with how Wakefield ran his study and recruited patients. Nonetheless, the revelations nearly a year ago about Wakefield’s playing fast and loose with research methodology could not help but contribute to the sense that the Good Ship Wakefield had been torpedoed below the water line and was taking on water fast.

As the investigation and hearings wound on seemingly endlessly for two and a half years, Wakefield’s supporters intermittently waged an increasingly histrionic and ridiculous propaganda offensive to try to preemptively discredit the GMC’s findings. As it became clear that finally after all this time the GMC was on the verge of announcing its ruling, I noticed that the anti-vaccine crank blog Age of Autism was ramping up an increasingly bizarre and unhinged last minute propaganda campaign, complete with reposting a hilariously inapt post by Mark Blaxill comparing Wakefield to Galileo and the GMC to the Inquisition, complete with references to Stalin and Mao (I suppose I should be relieved that Blaxill refrained from playing the Hitler card); a defense of “that paper” by Wakefield himself; claims that parent witnesses had been “silenced” at the GMC hearings; and a whole series of posts by John Stone trying to discredit the GMC.

And then on Thursday, the GMC ruled.

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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Yet another nail in the coffin of the myth that the MMR vaccine causes autism

Arguably, the genesis of the most recent iteration of the anti-vaccine movement dates back to 1998, when a remarkably incompetent researcher named Andrew Wakefield published a trial lawyer-funded “study” in the Lancet that purported to find a link between “autistic enterocolitis” and measles vaccination with the measles-mumps-rubella (MMR) trivalent vaccine. In the wake of that publication was born a scare over the MMR that persists to this day, 11 years later. Although peer reviewers forced the actual contents of the paper to be more circumspect, in the press Wakefield promoted the idea that the MMR vaccine either predisposes, causes, or triggers autistic regressions. Even though over the next several years, investigations by investigative journalist Brian Deer revealed that not only was Wakefield’s research funded by trial lawyers looking to sue vaccine manufacturers for “vaccine injury” when he did his research (for which he is now being charged by the U.K.’s General Medical Council with scientific misconduct), but during the Autism Omnibus trial testimony by a world-renowed expert in PCR technology showed that he was incompetent. Even worse for Wakefield, in February 2009 Brian Deer published a news expose based on strong evidence that Wakefield may very well have falsified data for his Lancet paper.

None of this mattered. Andrew Wakefield still enjoys a cult of personality among the anti-vaccine crowd that no revelation seems able to dislodge, even the revelation that at the time he was both in the pay of trial lawyers and working on his study, Andrew Wakefield was also applying for a patent for a rival measles vaccine. Indeed, the anti-vaccine propaganda blog Age of Autism bestowed upon him last year its “Galileo Award” as the “persecuted” scientist supposedly fighting for truth, justice, and anti-vaccinationism against the pharma-funded or brainwashed minions of the “Church of the Immaculate Vaccination.” In the meantime, MMR uptake rates in the U.K. have plummeted over the last decade, far below the level needed for herd immunity, to the point where, last year the Health Protection Agency declared measles to be once again endemic in the U.K., 14 years after the local transmission of measles had been halted.

Since Wakefield’s study was released, a number of studies have shown that there is no epidemiologically detectable link between vaccination with MMR and autism, including one by a researcher who once appeared to be a believer in the idea that vaccines are somehow linked with autism, Mady Hornig. Hornig actually tried very hard to replicate Wakefield’s 1998 Lancet study, only this time with more children, and she found no link between MMR and autism using methodology similar to Wakefield’s. None of these studies has had any effect on the anti-vaccine movement, except to motivate them to circle the wagons even more, as J.B. Handley of Generation Rescue did when he launched a website called Fourteen Studies, whose purposes are to launch fallacious and pseudoscientific attacks on studies failing to find a link between vaccines and autism (often involving accusations of being a “pharma shill”), to promote the lousy science that gives the appearance of supporting the hypothesis that there is a link between the MMR vaccine and autism, and then slime anyone who points out how deceptive their attacks were.

Now, yet another study has been released studying whether there is a link between MMR vaccination and autism. Yet another study has failed to find a link between MMR vaccination and autism. Yet another study is all set to be attacked by Generation Rescue and the anti-vaccine movement. The sad and sordid history of reactions of the anti-vaccine movement to studies that do not support its belief in the unsinkable rubber duck of a myth that vaccines cause autism. This study was published online in The Pediatric Infectious Disease Journal by a group from Department of Epidemiology and Preventive Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland (a Polish group, my people!) and entitled Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study. It’s yet another nail in the coffin of the myth that the MMR causes or contributes to autism. Indeed, this study not only shows that MMR vaccination is not associated with autism but that it may even be protective against autism. True, for reasons I will discuss shortly, I doubt that that latter interpretation is true, but there’s no doubt that this study is powerful evidence against the view that there is an association between MMR and autism. Unfortunately, I fear that all the nails in my local Home Depot would not be enough to keep the zombie of this pseudoscience from rising from its grave yet again.
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Posted in: Clinical Trials, Vaccines

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A Not-So-Split Decision

For those who battle tirelessly against the never ending onslaught of anti-vaccine propaganda, misinformation, and fear, there was great news the other day from Merck. The pharmaceutical company, and maker of the MMR vaccine against measles, mumps, and rubella, has decided not to resume production of the individual, or “split”, components of the vaccine. A Merck representative made the announcement during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on Tuesday. During previous ACIP meetings, science experts on that committee presented compelling arguments against  continued, large scale production of the monovalent components of the MMR vaccine, which were echoed by scientists in Merck’s vaccine division. In a moment, I’ll discuss the arguments against the split vaccine, and why this is so important a decision. First, some background on the issue of splitting the MMR.
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Posted in: Science and Medicine, Vaccines

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Monkey business in autism research, part II

Over the last couple of months, I’ve noticed something about the anti-vaccine movement. Specifically, I’ve noticed that the mavens of pseudoscience that make up the movement seem to have turned their sights with a vengeance on the Hepatitis B vaccine. The reason for this new tactic, I believe, is fairly obvious. The fact that the Hep B vaccine is administered shortly after birth seems somehow to enrage the anti-vaccine movement more than just about any other vaccine. Moreover, given that, aside from maternal-child transmission when the mother is infected, hepatitis B is usually only contracted through either bloodborne contact (the sharing of needles, the administration of contaminated blood) or sexual activity, it’s very easy for anti-vaccinationists to make a superficially plausible-sounding argument that it’s not a necessary vaccine, even though there are reasonable rationales for giving it to infants. The image of sticking a needle into a newborn infant trumps that, though, at least for the anti-vaccine movement. Another possibility, suggested by Steve Novella just yesterday, is that, with the collapse under a overwhelmingly huge pile of evidence of the idea that the mercury-containing preservative thimerosal that used to be used in childhood vaccines until 2001, caused an “epidemic” of autism and the failure of the “too many too soon” slogan to convince anyone who is not already an anti-vaccinationist, the movement needed a new bogeyman to blame for autism. The hepatitis B vaccine, which was added to the pediatric vaccination schedule in the 1990s, around the right time to confuse correlation with causation when it comes to the increase in autism diagnoses (just like thimerosal) was a perfect next target, given that it’s administered shortly after birth.

Indeed, just the other day, the anti-vaccine crank groups the National Vaccine Information Center (NVIC), Talk About Curing Autism (TACA), and the anti-vaccine crank blog Age of Autism posted a call for the elimination of hepatitis B vaccination for newborns:

Washington, DC – National Vaccine Information Center and Talk About Curing Autism are calling on President Obama to order the immediate suspension of the Centers for Disease Control and Prevention recommendation of the birth dose of the Hepatitis B vaccine after two recent studies linking the Hepatitis B vaccine to functional brain damage in U.S. male newborns and infant primates.  In a related development today, the United States Department of Health and Human Services, including the Health Resources and Services Administration and Centers for Disease Control and Prevention,  announced that 1 in every 91 children are now diagnosed with an autism spectrum disorder as reported in the November 2009 issue of Pediatrics. Previous data released by the CDC indicated a prevalence of 1 in every 150 children affected by the disorder.

Note how AoA not-so-subtly interposed the latest information about autism prevalence with its call to eliminate the birth dose of the hepatitis B vaccine. Very clever. By doing so, it linked the two in readers’ minds, as if one had something to do with the other. There’s no good scientific evidence that the hepatitis B vaccine has anything to do with the “autism epidemic.” Meanwhile, David Kirby is up to his usual nonsense, and the resident anti-vaccine propagandist at CBS News, Sharyl Attkisson, who has been known to feed Age of Autism information on at least one occasion in the past, served up this credulous, noncritical interview with Andrew Wakefield:

The quantity of misinformation in that single six minute video is far beyond the scope of this article. Were I to start dissecting it, I would not have time to do what the purpose of this article was intended to do: To deal with the study Wakefield is hawking. That’s why I leave the dissection of this pièce de résistance of disingenuousness and misinformation as an exercise for SBM readers–after reading the rest of this post, of course. Trust me, it will help you.

At the heart of this latest propaganda onslaught by the anti-vaccine movement are two studies, one a restrospective study in humans and the other a study in monkeys, both of which the anti-vaccine movement is promoting as slam dunk evidence that the hepatitis B vaccine is causing all sorts of horrific problems. Taking both of them on in one post is too much, even for my logorrheic tendencies. So I’ll deal first with Wakefield’s monkey study and then, either later this week or sometime next week, hopefully discuss the human study.
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Posted in: Public Health, Science and Medicine, Science and the Media, Vaccines

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Antivaccine hero Andrew Wakefield: Scientific fraud?

Pity poor Andrew Wakefield.

Actually, on second thought, Wakefield deserves no pity at all. After all, he is the man who almost single-handedly launched the scare over the MMR vaccine in Britain when he published his infamous Lancet paper in 1998 in which he claimed to have linked the MMR vaccine to regressive autism and inflammation of the colon, a study that was followed up four years later with a paper that claimed to have found the strain of attenuated measles virus in the MMR in the colons of autistic children by polymerase chain reaction (PCR). It would be one thing if these studies were sound science. If that were the case, then Wakefield’s work would have been very important and would have correctly cast doubt on the safety of the MMR. Unfortunately, they were not, and, indeed, most of the authors of the 1998 Lancet paper later withdrew their names from it.

Over the next decade, aided and abetted by useful idiots in the media, by British newspapers and other media that sensationalized the story, and the antivaccine movement, which hailed Wakefield as a hero, Wakefield managed to drive MMR vaccination rates in the U.K. below the level of herd immunity, from 93% to 75% (and as low as 50% in some parts of London). As a result Wakefield has been frequently sarcastically “thanked” for his leadership role in bringing the measles back to the U.K. to the point where, fourteen years after measles had been declared under control in the U.K., it was in 2008 declared endemic again.

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Posted in: Science and the Media, Vaccines

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