“Piltdown medicine” and Andrew Wakefield’s MMR vaccine fraud

Pity poor Andrew Wakefield. Well, not really. I tend to view what’s happening to him yet again as the chickens coming home to roost.

Let’s put it this way. 2010 was a terrible year for him, and 2011 is starting out almost as bad. In February 2010, the General Medical Council in the U.K. recommended that Wakefield be stripped of his license to practice medicine in the U.K. because of scientific misconduct related to his infamous 1998 case series published in The Lancet, even going so far as to refer to him as irresponsible and dishonest, and in May 2010 he was. This case series, thanks to Wakefield’s scientific incompetence and fraud, coupled with his flair for self-promotion and enabled by the sensationalistic credulity of the British press, ignited a scare about the measles-mumps-rubella (MMR) vaccine in which, afraid that the MMR vaccine causes autism, parents in the U.K. eschewed vaccinating their children in droves. As a result, vaccination rates plummeted far below the level necessary for herd immunity, with the entirely predictable result of massive measles outbreaks in the U.K. Measles, which as of the mid-1990s had been declared under control by British and European health authorities, came roaring back to the point where in 2008 it was declared once again endemic in the British Isles. In a mere decade and a half, several decades of progress in controlling this scourge had been unravelled like a thread hanging off a cheap dress, all thanks to Andrew Wakefield and scandal mongers in the British press.

True, Wakefield had long since moved to Texas, the better to be the founding “scientific director” of a house of autism woo known as Thoughtful House. Thus, the removal of his license to practice had little practical import (or effect on his ability to earn a living), or so it seemed at the time, given that Wakefield did not treat patients and hauled in quite the hefty salary for his promotion of anti-vaccine pseudoscience. Fortunately, karma’s a bitch, and, as a result of the GMC’s action, in short order The Lancet retracted Wakefield’s 1998 paper; Wakefield was pushed out of Thoughtful House; and his latest attempt to “prove” that vaccines cause autism in an animal study was also retracted. Investigative reporter Brian Deer’s investigation finding that Andrew Wakefield had committed scientific fraud in carrying out his Lancet study joined prior findings that Wakefield had been in the pocket of trial lawyers (to the tune of £435 643, plus expenses) seeking to sue the vaccine industry at the time he carried out his “research” and the allegations by renowned PCR expert Stephen Bustin during the Autism Omnibus as to how shoddily Wakefield’s other research was carried out. Finally, the mainstream media started to back away from its previous embrace of Wakefield and his claims. As a result, for a while at least, Wakefield was reduced to lame appearances at sparsely attended anti-vaccine rallies last spring.

The rest of the story

As bad as the findings were that Wakefield had committed scientific fraud, it turns out that it was even worse than the original reports indicated. A few hours ago, the British Medical Journal (BMJ) published an analysis of the scientific fraud committed by Wakefield, fraud that journalist Brian Deer likens in an accompanying editorial to the Piltdown Man. The articles are:

And here is CNN reporting on the story last night:

Even better, Deer’s article is part one of a planned two-part series, the next part of which will look at Wakefield’s business plans and how he came to be fired. Basically, these latest two articles will grind to dust any remaining “scientific resepctability” Wakefield might have enjoyed. Actually, it grinds it to even finer dust–nanoparticles that disappear into the air–given that Wakefield’s reputation had already been pulverized quite thoroughly last year by the GMC. Deer begins, as he began one of his news stories before, with the testimony of a parent of one of the 12 children that Wakefield included in his study:

Mr 11, an American engineer, looked again at the paper: a five page case series of 11 boys and one girl, aged between 3 and 9 years. Nine children, it said, had diagnoses of “regressive” autism, and all but one were reported with “non-specific colitis.” The “new syndrome” brought these together, linking brain and bowel diseases. His son was the penultimate case.

Running his finger across the paper’s tables, over coffee in London, Mr 11 seemed reassured by his anonymised son’s age and other details. But then he pointed at table 2–headed “neuropsychiatric diagnosis”–and for a second time objected.

“That’s not true.”

Child 11 was among the eight whose parents apparently blamed MMR. The interval between his vaccination and the first “behavioural symptom” was reported as 1 week. This symptom was said to have appeared at age 15 months. But his father, whom I had tracked down, said this was wrong.

“From the information you provided me on our son, who I was shocked to hear had been included in their published study,” he wrote to me, after we met again in California, “the data clearly appeared to be distorted.”

Then Deer describes exactly how Wakefield rigged his study under the pay of trial lawyers to appear to suggest a link between MMR vaccination and autism. For instance, before Wakefield ever undertook his infamous study, he and a solicitor named Richard Barr had claimed to have identified a new syndrome consisting of bowel inflammation and regressive autism and aimed to show a temporal association between MMR vaccination and the onset of first symptoms. Unfortunately, Child 11’s case was a disappointment, as his discharge summary from the Royal Free Hospital, which showed that the boy’s regression began two months earlier than claimed in Wakefield’s paper and a month before he had ever received his MMR vaccine. Deer also describes Child 2, whose parents were the first to have approached Wakefield, sent by the anti-vaccine group JABS. This boy appeared in numerous news reports and was one of the four “best cases” used by Barr in a lawsuit. The boy’s mother’s story was vague and she wasn’t clear on how long it was between the child’s vaccination and the onset of his symptoms.

But that’s not all. The more the paper was investigated, the more anomalies were found. For example, only one child clearly had regressive autism, and three of nine described as having regressive autism did not. In fact, none of these three even had a diagnosis of autism at all! There were other anomalies as well. Several of the children clearly had preexisting conditions. For example, all twelve children were described in the paper as “previously normal,” but at least two of them clearly had developmental delay and facial dysmorphisms noted before they were vaccinated with the MMR. All twelve children taken together did not support the existence of a syndrome of bowel problems and regressive autism, at least not the syndrome as described in Wakefield’s paper. Deer summarizes how Wakefield “fixed the link” between MMR and regressive autism with enterocolitis:

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

As Brian Deer so aptly puts it, Wakefield “chiseled” the data, “falsifying medical histories of children and essentially concocting a picture, which was the picture he was contracted to find by lawyers hoping to sue vaccine manufacturers and to create a vaccine scare.” The discrepancies between the case reports as described in Wakefield’s Lancet paper and the actual medical records are anything but random; all are in the direction of suggesting a link between the MMR and Wakefield’s as yet unverified syndrome of regressive autism and enterocolitis. The cases that were selected appear not to have been random, sequential patients but were rather recruited specifically through anti-vaccine activists and trial lawyers. Moreover, as Deer puts it:

Moreover, through the omission from the paper of some parents’ beliefs that the vaccine was to blame, the time link for the lawsuit sharpened. With concerns logged from 11 of 12 families, the maximum time given to the onset of alleged symptoms was a (forensically unhelpful) four months. But, in a version of the paper circulated at the Royal Free six months before publication, reported concerns fell to nine of 12 families but with a still unhelpful maximum of 56 days. Finally, Wakefield settled on 8 of 12 families, with a maximum interval to alleged symptoms of 14 days.

Between the latter two versions, revisions also slashed the mean time to alleged symptoms–from 14 to 6.3 days. “In these children the mean interval from exposure to the MMR vaccine to the development of the first behavioural symptom was six days, indicating a strong temporal association,” he emphasised in a patent for, among other things, his own prophylactic measles vaccine, eight months before the Lancet paper.

Yes, that’s exactly what Deer has found. When the time frame between vaccination and the onset of symptoms was too long to be useful for suggesting a link between MMR and regressive autism with enterocolitis, Wakefield systematically removed subjects whose parents blamed the MMR for their children’s autism until the time frame between vaccination and onset of symptoms in the remaining subjects was a much more impressive 14 days. There is no innocent explanation possible for the systematic and numerous discrepancies between the medical record and Wakefield’s paper, as the editors of the BMJ point out in their accompanying editorial:

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.

The antivaccine movement circles the wagons again

The degree of falsification and the number of discrepancies were breathtaking in their audacity and contempt for reviewers and Wakefield’s own collaborators, ten of whom retracted their names from the study back in 2004, when strong evidence of a serious conflict of interest on Wakefield’s part was first unearthed by Deer. The chutzpah Wakefield demonstrated in his fraud was truly breathtaking. So is the chutzpah he continues to exhibit today with his denials. Even after this report and all the stories reporting on it, Wakefield continues to deny that he has done anything at all wrong and blames the criticisms leveled against him on conspiracies. In reality, given the way the anti-vaccine movement has begun to circle the wagons to defend Wakefield yet again, it’s tempting to claim that this is a conspiracy. Personally, I consider it a conspiracy of utter cluelessness. For one example, check out this video of J.B. Handley:

Yes, Handley’s regurgitating antivaccine favorites like the “tobacco science” mischaracterization, touting Wakefield’s “monkey business” study (which he neglects to mention was withdrawn), and defending Wakefield. I will say one thing, though. Handley actually managed to keep himself from having one of his characteristic outbursts, although it was obvious that he was on the verge of one of his typical rants. Perhaps he’s had some media training since his last appearance on The Doctors or Larry King’s show.

For another example, check out this defense of Andrew Wakefield by the anti-vaccine National Autism Association, which makes the astonishingly ludicrous claim that the BMJ article is “yet another attempt to thwart vaccine safety research.” The anti-vaccine crank blog Age of Autism naturally reposted the NAA’s counterattack.

One of the NAA’s claims in its press release is that Wakefield’s study has been “repeatedly confirmed,” and the NAA cites five studies that allegedly confirm Wakefield’s fraudulent results. However, as Just the Vax and Sullivan show, these studies do not represent independent confirmation of anything. One of them was by a close associate of Wakefield; one is a case report of an adult autistic with enterocolitis; and none of the rest confirm Wakefield’s results either. Yet, every time a story pops up showing that Wakefield committed scientific fraud, Wakefield defenders in the anti-vaccine movement dutifully trot out the same five studies, as though any of them were independent confirmation of his work, while anti-vaccine activists launch ad hominem attacks against BMJ editor Fiona Godlee and regurgitate old attacks on Brian Deer. Particularly off-base is the NAA’s claim that somehow, by laying bare Wakefield’s clear cut and vile scientific fraud, the BMJ is interfering with “vaccine safety research.” No, it’s revealing a dangerous scientific fraud, nothing more.

“Piltdown medicine”

So egregious was Wakefield’s fraud that Deer likens it in an accompanying blog post to “Piltdown medicine,” making this direct comparison to the infamous “Piltdown Man” hoax:

The Piltdown contrivance involved the pre-arranged “discovery” of features brought together to be sensationally “found.” A piece of skullcap was human, a partial jaw was an orangutan’s, and a tooth was a chimpanzee’s, filed down. They were stained with chemicals and, to fabricate a temporal link, were buried with flint tools in datable gravel near the tiny village of Piltdown, East Sussex.

Some would suggest that their proximity was a matter of chance, but the odds of this would have taxed an astronomer. “That two different individuals were present,” one of the scientists who unmasked the fraud explained later, “a fossil man, represented by a cranium without a jaw, and a fossil ape, represented by a jaw without a cranium, within a few feet of each other and so similar in colour and preservation, would be a coincidence, amazing beyond belief.”

And so it was with Wakefield, eight decades after the Piltdown discoveries. Amazing beyond belief. For skullcap read “developmental disorders”, for the jaw “enterocolitis”, and for the tooth “parental complaints about MMR”. Bring them together at one hospital, with a 14-day temporal link, and another assemblage was “found”.

This is a very apt analogy. The more we find out about how Wakefield put together his case series for The Lancet, the more it becomes obvious that he calculatingly put together a fraud every bit as elaborate and planned as the Piltdown Man hoax. It might not have taken as long for Wakefield’s fraud to come to light. Although there were suspicions that not everything was as it appeared as early as within the first year after Wakefield’s case report, it was not until 2004 that serious allegations came to light of Wakefield’s conflict of interest. These allegations ultimately led to the GMC hearing that began in 2007 and the findings of scientific fraud announced nearly a year ago. Now, here it is, thirteen years later, and only now is the full story being told.

What I can’t figure out–I mean, really, really can’t figure out–is why the anti-vaccine movement continues to cling to Wakefield’s tattered “science” and lionize this fraud as a hero. Surely the more sober and intelligent members of the anti-vaccine mvoement (they do exist, believe it or not) must realize by now that Wakefield has become a huge liability. This was best demonstrated last year, when, after years of doing nothing about him, as soon as the GMC found Wakefield had committed scientific fraud, in short order The Lancet retracted his paper, Thoughtful House fired him, and his “monkey business” paper, which was to be his “comeback” as far as scientific respectability goes, was also retracted. Wakefield is now very much like the Black Knight in Monty Python and the Holy Grail, who, having had his arm hacked off by King Arthur declares it to be “just a flesh wound.” After hacking off all but the Black Knight’s left leg, the Black Knight keeps taunting Arthur, who retorts, “What are you going to do, bleed on me?” and finally, unable to take any more, cuts off the Black Knight’s last leg.

This article by Brian Deer is the last swing of the sword that hacks off Wakefield’s last limb.

Unfortunately, like the Black Knight, not realizing that, scientifically he’s been utterly discredited, Wakefield fights on. Worse, he is still feted by the anti-vaccine movement. Right now, he’s in Jamaica as part of a “vaccine safety” conference whose list of speakers is chock full of anti-vaccine activists.

For Wakefield, even 13 years later, fraud pays.

Posted in: Health Fraud, Neuroscience/Mental Health, Vaccines

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