Feb 01 2010
The General Medical Council to Andrew Wakefield: “The panel is satisfied that your conduct was irresponsible and dishonest”
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.
ANDREW WAKEFIELD: “IRRESPONSIBLE” AND “DISHONEST”
The general findings in the GMC’s ruling should have come as no surprise at all to anyone who had been following Wakefield’s activities, as I have been for the last five years, although I must admit I was pleasantly surprised by the lack of weasel words in it. On Thursday, the BBC reported:
Dr Andrew Wakefield’s 1998 Lancet study caused vaccination rates to plummet, resulting in a rise in measles — but the findings were later discredited.
The General Medical Council ruled he had acted “dishonestly and irresponsibly” in doing his research.
No kidding. Here is a sentence from the actual GMC report:
In reaching its decision, the Panel notes that the project reported in the Lancet paper was established with the purpose to investigate a postulated new syndrome and yet the Lancet paper did not describe this fact at all. Because you drafted and wrote the final version of the paper, and omitted correct information about the purpose of the study or the patient population, the Panel is satisfied that your conduct was irresponsible and dishonest.
The Panel is satisfied that your conduct at paragraph 32.a would be considered by ordinary standards of reasonable and honest people to be dishonest.
That’s about as plain a statement of Wakefield’s mendacity as I can imagine. In fact, I’m very surprised that the GMC report was so blunt. But wait, there’s more, as described in this BBC news report:
The verdict, read out by panel chairman Dr Surendra Kumar, criticised Dr Wakefield for the invasive tests, such as spinal taps, that were carried out on children and which were found to be against their best clinical interests.
The panel said Dr Wakefield, who was working at London’s Royal Free Hospital as a gastroenterologist at the time, did not have the ethical approval or relevant qualifications for such tests.
The GMC also took exception with the way he gathered blood samples. Dr Wakefield paid children £5 for the samples at his son’s birthday party. Dr Kumar said he had acted with “callous disregard for the distress and pain the children might suffer.”
He also said Dr Wakefield should have disclosed the fact that he had been paid to advise solicitors acting for parents who believed their children had been harmed by the MMR.
Two of Dr Wakefield’s former colleagues at the Royal Free were also ruled to have broken guidelines.
Professor John Walker-Smith and Professor Simon Murch both helped Dr Wakefield carry out the research.
The complete 143 page report can be read here. It is truly a damning document. While it cleared Wakefield of some charges, it found that Wakefield was in breach of managing public finances, that the funds he controlled were not used for their intended uses, and that, most shocking of all, he performed procedures on a child for research purposes without the approval of his Ethics Committee. Having found that some of the most damning allegations made against Wakefield are true, the GMC will now deliberate over what sanctions will be indicated. These can range from a rebuke to the stripping of Wakefield’s medical license from him (or, as the British put it, his being “struck off”). Of course, given that Wakefield has moved to Austin, Texas, there to form Thoughtful House, an institution dedicated to the practice of what many, including myself, consider to be autism quackery based on anti-vaccine beliefs, even if the GMC does ultimately strip Wakefield of his medical license very likely it would have little or no significant effect on his practice. After all, Wakefield does not treat children himself. He can’t. He does not have a Texas medical license. Wakefield’s partner Dr Arthur Krigsman is the one doing colonoscopies on autistic children for what appear to be questionable indications, as was portrayed in the aforementioned NBC special with Matt Lauer, and his other partner Dr Bryan Jepson treats them with DAN! protocols.
Indeed, well do I remember one part of the Lauer special in particular. Specifically, it was the part where Lauer asked for Wakefield’s anecdotal experience about whether these children “get better.” Wakefield, of course, responded in the affirmative. (Never mind that what Lauer should have asked Wakefield is whether he has data from randomized controlled clinical trials to support his belief that autistic children “get better” at Thoughtful House. He doesn’t.) Moreover, pretty much every child undergoing endoscopy at Thoughtful House (85%, according to Dr Krigsman) ends up with a diagnosis of “autistic enterocolitis,” which is, as far as science can tell, almost certainly a nonexistent syndrome given that autistic children do not appear to exhibit bowel complaints at a higher frequency than neurotypical children. In the case of Tom Kasemodal, the autistic child whose endoscopy was featured in the NBC report, Dr Krigsman was hard-pressed to find grossly visible abnormalities during the procedure. (“Mild or softer findings,” he said about Tom.) Of course, on pathology, Thoughtful House pathologists apparently found “mild inflammation.” And what did Krigsman prescribe? Lots of supplements, daily laxatives, and periodic colon cleansing. Can you imagine subjecting an autistic child to laxatives and colon cleanses? How do you get a severely autistic child to cooperate for a “colon cleanse”? I have no idea, and I don’t want to think about it.
If the NBC report with Matt Lauer is any indication, apparently such is the “medicine” practiced at Thoughful House, and I must emphasize that the GMC ruling will almost certainly do absolutely nothing to stop it. As when he was at the Royal Free Hospital in North London, Wakefield bills himself as a “researcher” and does not practice clinical medicine, at least not on the surface of it, although the NBC special sure made it look to me as though he participates as a consultant in the care of the autistic children brought to Thoughtful House. If the GMC were to “strike off” Wakefield from the rolls of licensed physicians, it would at least be a further moral victory in addition to the ruling itself, but Thoughtful House would still exist and, under Wakefield’s leadership, still be subjecting autistic children to the sorts of therapies shown on the NBC report and who knows what else.
ANDREW WAKEFIELD, “BRAVE MAVERICK DOCTORS,” AND A CULT OF PERSONALITY
In the decade since his Lancet paper began the movement that led to the resurgence of measles in the U.K., Andrew Wakefield has become a hero to the movement dedicated to the discredited idea that vaccines cause autism. He is the prototypical “brave maverick doctor” and don’t need no steeenkin’ science to know that he’s “recovering” autistic children. Evidence of this is everywhere; so I’ll pick and choose. Perhaps the most obvious manifestation of the Wakefield cult of personality is the nausea-inducing website We Support Dr Andrew Wakefield. I first became aware of this website last year after Brian Deer’s revelations regarding the likely scientific fraud committed by Andrew Wakefield came to light. Consistent with its defense of Wakefield then, on the day that the GMC’s findings were announced, the website declared it a “sad day for the future of our children” and further declared:
The General Medical Council’s (GMC) verdict today concerning Dr Andrew Wakefield brings together autism organizations across the United States who stand united in support of him, unequivocally renounce the GMC’s findings, and demand an investigation into possible conflicts of interests at the GMC. We further challenge the U.K. and U.S. governments to offer grants for gold standard research into why so many children with autism have gastrointestinal pathology, as well as any links between this pathology and the symptoms of autism, before all of the children of the world are affected.
Today’s verdict by the General Medical Council epitomized their negligence in respecting all of the sound scientific studies worldwide replicating the findings of Dr Andrew Wakefield. In the United States we will continue to fund studies replicating Wakefield’s work. We will focus more heavily on helping to educate the British public about the dangers of the MMR. We will look with renewed vigor into possible misconduct by the GMC. And, most importantly, we will continue to recover children from autism thanks, in large measure, to Dr Wakefield’s pioneering work. We have witnessed and applaud the sustained courage and dignity of Dr Andrew Wakefield. He has stood by the children, and we will stand by him.
This statement is signed by AutismOne (which I’ve discussed before), the Autism Research Institute, Generation Rescue (big surprise there, given that GR has already declared its support for Andrew Wakefield in no uncertain terms and, in the lead up to the GMC’s findings, tried its best to demonize GMC and cast doubt on the legitimacy of the entire proceeding), SafeMinds, Schafer Autism Report, Talk About Curing Autism (TACA), Unlocking Autism. In other words, organizations supporting the scientifically discredited vaccine-autism link are all lining up to support this statement. Notice how the statement alleges conflicts of interest and misconduct on the part of the GMC without any actual evidence of such COIs. Also notice how it declares that other researchers have “replicated” the findings of Andrew Wakefield. Of course, that is true if you count the dubious and researchers associated with Wakefield himself, but no reputable researchers have been able to replicate his findings. Most recently, as I pointed out above, a sympathetic researcher named Mady Hornig, who had previously published research seemingly supporting a link between thimerosal and autism, failed to replicate Wakefield’s results. Finally, notice how, despite numerous studies supporting the safety of the MMR and its lack of association with autism or bowel complaints in autism, these organizations continue to cling to the belief that the MMR is “dangerous” and vow to “educate” the public about the “dangers” of the MMR vaccine.
Consistent with previous reactions to criticisms of the anti-vaccine movement or one if its leaders, some of these organizations are also going on the attack, painting themselves as the underdog being persecuted for speaking truth to power. For instance, here’s what the TACA wrote:
The most frightening aspect of these GMC findings is the silencing effect it could cause to scientist and researchers. These verdicts now prove that researchers who stumble upon science that is controversial have to worry about losing their licenses and careers.
Consistent with the persecution complex that the anti-vaccine movement has, yesterday AoA contributor Martin Walker tried with some truly Bulwer-Lytton-worthy writing and incredibly heated rhetoric to show just how much reason has checked out among Wakefield’s defenders:
As the recitation of the crimes of Dr Wakefield came to an end, it appeared as if Dr Wakefield, had in the mid nineties, been some kind of inhuman Nazi experimenter practicing on children in the heart of England; an overlooked human vivisector who stalked a large North London hospital committing serious crimes with the two other criminals in his firm, invisible to his colleagues and unseen by the hospital administration.
It’s actually funny that Walker would mention Nazis. It was Nazi experimentation, among other things, that led to the Helsinki Declaration, the Belmont Report and the Common Rule in the US, and all the other protections for human subjects involved in clinical research. These rules are quite strict, although some would argue whether they’re even strict enough. They prevent atrocities like the Tuskegee syphilis experiment. They are the same rules that Wakefield flouted.
Undeterred by reality, Walker then likens the ruling to a knight’s jousting (and you don’t have to guess who’s the Black Knight):
Today I know will be one of those times that signify a dark night of the soul, for defendants, parents and campaigners alike. This afternoon the defendants will be knocked from their horses by rib smashing lance blows, on the ground they will lie dazed and have to figure whether it is right or even possible to remount and continue the battle. Parents will contemplate the bleak landscape of their children’s illness without any treatment and with open skepticism from medical practitioners from whom they seek help. Activists and campaigners like myself will have to face the melancholic prospect of either continuing the campaign or slipping away to support apparently more equitable battles.
This particular battle is a post-modern struggle, one in which the most powerful forces, multinational companies, reshape the world hand in hand with governments. This is a struggle from which parents and citizens have been expunged. A blind struggle, in an age where all the ties between governments and citizens have been severed, where it is no longer possible for citizens to have any real effect on either the processes of industrial science or of national politics.
It’s a post-modern struggle alright, just not in the way that Walker means.
Perhaps the most over-the-top conspiracy-packed “defense” of Andrew Wakefield comes from Mark Blaxill, published on the anti-vaccine crank blog Age of Autism and entitled Naked Intimidation: The Wakefield Inquisition is Only the Tip of the Autism Censorship Iceberg. All the hallmarks of a persecution complex and crankery are there.
Claims that the GMC finding was designed to “intimidate” those “brave maverick scientists”? Check:
The GMC proceeding is a frightening and thoroughly modern form of tyranny. It makes you shudder to think what Stalin or McCarthy might have accomplished if their public relations had been more skillful and better organized.
The extremity of the GMC’s verdict — all three men guilty on all counts — lays bare any pretense that the British medical establishment cares one whit about the welfare of its patients. Let’s put in perspective the actions at issue here. No children were harmed and no parent or guardian has complained about the care these three men provided. In fact, the procedures involved were routine, the resulting treatments standard and the careful attention to gastrointestinal illness in autistic children has recently been endorsed by a consensus statement published in the journal Pediatrics (no friend of the autism community). Considered in this light, the GMC hearing process stands exposed for what it is. It was not about medical standards. It was not about evidence. It was not even civilized. It was, rather, a naked exercise in intimidation, a fateful moment of moral decision in which the medical industrial complex exposed its ruthless, repressive essence. They are a frightening bunch and their conduct here raises issues well beyond autism.
The only thing frightening about this case is how much Andrew Wakefield got away with and how long it took for him to be exposed as the unethical fraud he’s been shown to be by Brian Deer, the GMC, and numerous other sources. It should also be noted that Wakefield was not found “guilty on all counts,” although he was found guilty on several of the most egregious counts. Blaxill really should read the whole report.
Attacks on peer review? Of course, they’re there too:
Since the National Institutes of Health (NIH) hold a virtual monopsony (“a sole or predominant buyer” in a particular market) on scientific research in the United State, NIH grant reviews are one prominent place where researchers can be effectively intimidated. One scientist, who authored a sensitive, previous publication, when asked to join in the effort to draft a review paper, demurred with the following explanation.
I have had two rejections of NIH grants in the last two weeks. This is most remarkable, in that the grants were not deemed good enough to even be scored. In my X years on the faculty, I have never had an unscored grant. Moreover, in one grant it is clear that there is a personal vendetta ongoing. This is not totally surprising but nonetheless disturbing. I am not ready to throw my career away, and I don’t look at how Andy Wakefield has handled such problems as a good model for me. It is vital that the science of this problem get out, and this is where I want to focus my attention. Therefore, I have decided that I do not want my name on [this new review publication], for I don’t need more persecution right now, and as good as the paper is (and I think it is extraordinary), it is not going to be a definitive scientific publication. I am enclosing a section I wrote-some of this is already included-feel free to use any of it.
If an intrepid researcher goes so far as to submit a paper for publication, that’s where the more overt forms of censorship can enter in, all in the guise of “peer review.” Admittedly, rejection at the point of peer review is a common part of science, but the autism problem is especially radioactive and is a place where I have seen the unmistakable cold hand of censorship take many forms: some unwelcome research can be headed off at the pass, with journal editors making clear that papers on certain autism topics are unwelcome and won’t even be sent out for review; or unwelcome papers can be sent to anonymous reviewers the editor knows to be hostile to the topic of environmental influences;
Let’s see: I just found out on Friday that not only was a revision of a paper I wrote still not deemed acceptable for publication in the journal to which I submitted it, but I also found out that I didn’t get a grant I really wanted that I had thought I had a good chance of getting. That’s academia and biomedical science. It happens all the time (although I can’t recall having had such a one-two body blow to my ego in one day). The latter case is somewhat apt in that the reviewers praised my proposed experimental design as being excellent but were skeptical of the primary hypothesis itself. Obviously, I must be too close to The Truth about breast cancer and how to treat it, and the breast cancer industry is trying to “silence” me! (Yeah, yeah, that’s what I’ll tell myself.) In any case, the complaint that “I’ve never had a grant not scored” is not indicative of “censorship.” The amount of money available for the NIH to fund grants compared to the number of grants submitted fell precipitously between 2003 and 2009. Lots of senior researchers who had never had a grant found to be “not worthy” of being given a numeric score (which indicates that the study section deemed it to be in the bottom half–or even bottom 60% — of the grants being ranked and therefore possessing no chance of being funded that round) have suddenly had grants coming back unscored. (Join the club and stop whining, those of us in the trenches ruefully respond!) In these tight fiscal times, that’s just reality. In this sort of environment, though, it’s easy for scientists to tell themselves that they’re the victim of groupthink whether there’s anything to it or not.
However, Blaxill had more in store for me. He completely shattered yet another of my irony meters when he wrote his conclusion:
The GMC verdict, that honest scientists like Andy Wakefield have “failed in their duty”, makes a mockery of the value of civil debate in an open society.
The medical industrial complex is closing ranks. It’s time for responsible citizens — health consumers and principled scientists alike — to raise their voices in opposition.
No, the anti-vaccine movement has made a mockery of civil debate in an open society. Its reflexive reaction to attack the messenger when criticized is legendary. Journalists have been the victims of it. Our fearless leader Steve Novella has been a victim of it. Paul Offit has been nearly continuously a victim of such bile and harassment, up to and including frivolous lawsuits. Sometimes, it gets incredibly vicious, as when AoA represented Paul Offit, Steve Novella, and journalists Trine Tsouderos and Amy Wallace as sitting down to have a Thanksgiving feast, the main course of which was a dead baby. I myself have been harassed similarly on many occasions.1,2,3,4,5,6,7
I suppose that’s the definition of “civil” debate from the anti-vaccine movement.
THE CULT OF ANTIVACCINATIONISM
As I have pointed out on numerous occasions before, both here and elsewhere, the anti-vaccine movement has much in common with cults. It believes, despite all scientific evidence, that vaccines cause autism and many other chronic health conditions. Its adherents see themselves as the keeper of a hidden truth that “they” don’t want you to know about, a “truth” that it desperately wants everyone to know. No facts, no science can sway them, and when one of their prophets is found to have behaved unethically, to have had massive conflicts of interest, and possibly even to have falsified research, it’s all part of a plot by The Man to keep them down.
That is why, as necessary as it is for the GMC to have ruled against Andrew Wakefield, I know that it will not stop him from plying his trade on children in Texas, and I especially know that it will only feed his cult of personality by adding martyr to his list of attributes in their eyes. It will not stop him from raking in money hand over fist. Even videos like this showing Wakefield joking over children fainting and throwing up as he prepared to draw blood from them after bribing them to agree to it won’t change that:
Yes, that is laughter and joking, and that is one incident that led the GMC to declare Andrew Wakefield’s “callous disregard” for children. That is the real Andrew Wakefield.
When will the madness end? I fear that it will only end when vaccine-preventable diseases return to the point where every parent fears them again. No, it’s more than that. Vaccine-preventable diseases are already returning. That’s why I fear it will only end when they return to the point where the fear of disease is more intense than the fear of the vaccine-autism bogeyman. In the meantime, while Third World countries clamor for life-saving vaccines and Bill Gates pledges $10 billion to bring vaccines to the world, here in the developed world we have men like Andrew Wakefield feeding an irrational fear of vaccines that threatens to reverse all the progress of the last few decades.
Maybe 20 years from now, we’ll need the Bill and Melinda Gates Foundation to be pledging billions of dollars to bring vaccines to us.
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