Nailed: Dr Andrew Wakefield and the MMR - autism fraudIt's not like it's going to stop the anti-vax crowd though...
Summary of Brian Deer's investigation into a threat to children's health
With a series of stories spread over six years, Brian Deer has pursued a landmark public interest investigation for The Sunday Times of London and the United Kingdom's Channel 4 Television network into allegations - first made in Britain - linking the three-in-one measles, mumps and rubella vaccine (MMR) with claims of a terrifying new syndrome of bowel and brain damage in children. These allegations led to a decade-long health crisis in the UK, and sparked epidemics of fear, guilt and infectious diseases, which have been exported to the United States and other developed countries, spawning every kind of concern over vaccinations.
Almost incredibly, the trigger for what would become a worldwide controversy was a single scientific research paper published in a medical journal - the Lancet - in February 1998. Written by a 41-year-old laboratory researcher, Dr Andrew Wakefield, and co-authored by a dozen other doctors, it reported on the cases of 12 anonymous children with developmental disorders, who were admitted to a paediatric bowel unit at the Royal Free hospital in Hampstead, north London, between July 1996 and February 1997.
Backed by a press conference and a video news-release, the five-page paper’s claims received huge media attention, and were followed by a sustained attack on the vaccine. This included further publications by Wakefield, criticising MMR, and led to an unprecedented collapse in public confidence in the shot, which, since the late 1980s in the UK and the early 1970s in the US, has been given almost universally to children, soon after they are one year old, almost eradicating measles and rubella.
The prime cause of the alarm was findings in the paper claiming that the parents of two thirds of the 12 children blamed MMR for the sudden onset of what was described as a combination of both an inflammatory bowel disease and what Wakefield called "regressive autism", in which language and basic skills were said to have been lost. Most disturbingly, the first behavioural symptoms were reported to have appeared within only 14 days of the shot.
Although the research involved only a dozen children, and its results have never been replicated, many medical breakthroughs have begun with small-scale observations, and, if true, Wakefield's findings might have been the first snapshot of a hidden epidemic of devastating injuries. "It's a moral issue for me," he said at the 1998 press conference, where he called for a boycott of the triple MMR, in favour of breaking it up into single shots, to be given at yearly intervals. "I can't support the continued use of these three vaccines, given in combination, until this issue has been resolved."
As the doctor campaigned, UK vaccination rates slumped: below the level needed to keep measles at bay. Even Tony Blair became embroiled in the controversy when Wakefield supporters suggested - the Blairs say wrongly - that the prime minister’s youngest son was not vaccinated with MMR. Meanwhile in America, a ferocious anti-vaccine movement took off, after Wakefield appeared on the CBS network's 60 Minutes programme in November 2000, speaking of an "epidemic of autism". This was followed by claims that all vaccines are suspect: either due to their content, or because of an increase in the number given to children.
"In 1983 the shot schedule was ten. That's when autism was one in 10,000. Now there's 36, and autism is one in 150," argued American actress Jenny McCarthy, who blamed MMR for her own son’s autism, and gained the highest profile in the US movement. "All arrows point to one direction."
Andrew Wakefield's role unmasked
But, as journalists queued to report on parents' fears, Brian Deer was assigned to investigate the crisis, and unearthed a scandal of astounding proportions. He discovered that, far from being based on any findings, the public alarm had no scientific basis whatsoever. Rather, Wakefield had been payrolled to create evidence against the shot, and, while planning extraordinary business schemes, meant to profit from the scare, he had changed and misreported data on the anonymous children to rig the results published in the journal.
Before Deer’s inquiries, Wakefield had appeared to all the world to be an independent, if controversial, researcher. Tall and square-headed, with hooded eyes and a booming voice, he was the son of doctors (a neurologist and a family practitioner), had grown up in Bath, a prosperous, west-of-England spa town, and joined the Royal Free in November 1988, after training in Toronto, Canada. His demeanour was languid - he was privately educated - and, born in 1956, he was a lingering example of the presumed honour of the upper middle class.
But the investigation discovered that, while Wakefield held himself out to be a dispassionate scientist, two years before the Lancet paper was published - and before any of the 12 children were even referred to the hospital - he had been hired by a lawyer, Richard Barr: a jobbing solicitor in the small eastern English town of King's Lynn, who hoped to raise a speculative class action lawsuit against drug companies which manufactured MMR.
Unlike expert witnesses, who give professional advice and opinions, Wakefield negotiated a lucrative contract with Barr, then aged 48, to conduct clinical and scientific research. The goal was to find evidence of what the two men called "a new syndrome", intended to be the centrepiece of (later failed) litigation on behalf of an eventual 1,600 families, mostly recruited through media stories. This, publicly undisclosed, role for Wakefield created the grossest conflict of interest, and the exposure of it by Deer, in February 2004, led to public uproar in Britain, the retraction of the Lancet report's conclusions section, and, from July 2007, the longest-ever professional misconduct hearing by the UK's General Medical Council.
Barr [audio] paid the doctor with money from the UK legal aid fund: run by the government to give poorer people access to justice. Wakefield charged at the extraordinary rate of £150 an hour - billed through a company of his wife's - eventually totalling, for generic work alone, what the UK Legal Services Commission, pressed under the freedom of information act, said was £435,643 (about $750,000 US), plus expenses. These hourly fees - revealed in The Sunday Times in December 2006 - gave the doctor a direct, personal, but undeclared, financial interest in the results of his research: totalling more than eight times his reported annual salary, and creating an incentive not only for him to launch the alarm, but to keep it going for as long as possible.
In addition to the personal payments was an initial award of £55,000, applied for by Wakefield in June 1996 - but never declared to the Lancet, as it should have been - for the express purpose of conducting the research later submitted to the journal. This start-up funding was part of a staggering £18m of taxpayers' money eventually shared among a group of doctors and lawyers, working under Barr's and Wakefield's direction, to try to prove that MMR caused the previously unheard-of "syndrome". Yet more surprising, Wakefield had predicted the existence of such a syndrome - which he would later dub "autistic enterocolitis" - before he carried out the research.
This Barr-Wakefield deal was the foundation of the vaccine crisis, both in Britain and throughout the world. "I have mentioned to you before that the prime objective is to produce unassailable evidence in court so as to convince a court that these vaccines are dangerous," the lawyer reminded the doctor in a confidential letter, six months before the Lancet report.
And, if this was not enough to cast doubt on the research's objectivity, The Sunday Times and Channel 4 investigation unearthed another shocking conflict of interest. In June 1997 - nearly nine months before the press conference at which Wakefield called for single vaccines - he had filed a patent on products, including his own supposedly "safer" single measles vaccine, which only stood any prospect of success if confidence in MMR was damaged. Wakefield denied any vaccine plans, but his proposed shot, and a network of companies intended to raise venture capital for purported inventions - including a vaccine, testing methods, and strange potential miracle cures for autism - were set out in confidential documents. One business was later awarded £800,000 from the legal aid fund on the strength of now-discredited data which he had supplied.
Behind the veil of confidentiality
As with the researcher, so too with his subjects. They also were not what they appeared to be. In the Lancet, the 12 children (11 boys and one girl) were held out to be merely a routine series of kids with developmental disorders and digestive symptoms, needing care from the London hospital. That so many of their parents blamed problems on one common vaccine, understandably, caused public concern. But Deer discovered that the children (aged between 2½ and 9½) had been recruited through MMR campaign groups, and that, at the time of their admission, most of their parents were clients and contacts of the lawyer, Barr. None of the 12 lived in London. Two were brothers. Two attended the same doctor's office, 280 miles from the Royal Free. Three were patients at another hospital clinic. One was flown in from the United States.
The investigation revealed, moreover, that the paper's incredible finding of a sudden onset of autism after vaccination was a sham: laundering into medical literature, as apparent facts, the unverified, often vague, memories and assertions of a group of unnamed parents who, unknown to the journal and its readers, were bound to blame MMR when they came to the hospital, because that was why they had been brought there. Wakefield, a former trainee gut surgeon, denied this. But the true number of families accusing MMR wasn't eight, as the paper said: it was 11 of the 12 (later all 12) and, in some cases, records noted the children's legal involvement before they were even referred.
"Mum taking her to Dr Wakefield, Royal Free hospital, for CT scan, gut biopsies," wrote one family doctor in the north-east of England, for example, before referring the only little girl in the project. "Will need ref letter. Dr Wakefield to phone me. Funded through legal aid."
In the light of these discoveries, the case was overwhelming to dig deeper into Wakefield's findings. In an exercise never before accomplished by a journalist, Deer was able to go behind the face of the 1998 paper, identify the subjects, and access original patient data. Penetrating veils of medical confidentiality, he discovered that the hospital's clinicians and pathology service had found nothing to implicate MMR, but that Wakefield had repeatedly changed and misreported diagnoses, histories and descriptions of the children, which made it appear that the syndrome had been discovered.
As revealed in The Sunday Times in February 2009, the effect was to give the impression of a link between MMR, bowel disease and the sudden onset of regressive autism, when otherwise none was evident. The hospital's pathology service had repeatedly declared bowel biopsies from the children to be normal, and not one of the 12 cases was free of critical mismatches between the paper which launched the vaccine crisis and the kids' contemporaneous clinical records. Some children showed signs of autism before vaccination. Some were deemed normal months afterwards. Some did not have autism at all.
"From the information you provided me on our son, who I was shocked to hear had been included in their published study," said the father of a boy from northern California, who was admitted, at age 5, to Wakefield’s research, "the data clearly appeared to be distorted."
Children's protections sidelined
In addition to finding that the Lancet paper had been rigged, the investigation uncovered a raft of other issues: starting with irregularities in ethical supervision. Research on patients is governed by national and international standards - particularly the Helsinki declaration - and no reputable hospital review board would have endorsed the kind of fishing expedition Wakefield embarked on for Barr. Without that endorsement, moreover, no major medical journal would have published any resulting paper. Nevertheless, to satisfy the Lancet's stringent patient-protection requirements, but without revealing to hospital authorities what was really going on, Wakefield falsely reported that a gruelling five-day battery of invasive and distressing procedures performed on the kids, including anaesthesia, ileocolonoscopies, lumbar punctures, brain scans, EEGs, radioactive drinks and x-rays, proposed for the lawsuit, was approved by the Royal Free's ethics committee.
But Deer revealed that, despite the research being executed on the uniquely vulnerable, developmentally challenged children of sometimes desperate parents, the ethics committee was not told the truth about the project, and had given no such approval. Wakefield and his key associates issued a formal statement denying this explosive discovery, but later changed their story and admitted it during the General Medical Council hearing, where - despite clear rules - they now argued they needed no approval.
Wakefield's basic science was also probed. The story was much the same. He had obtained the legal money and planned his business ventures against a theory of his own that the culprit for both inflammatory bowel disease and autism was persistent infection with measles virus, which is found live as a normal part of MMR. But Deer revealed on Channel 4 that sophisticated, unreported, molecular tests carried out in Wakefield's own lab had found no trace of measles in the children's guts and blood. Those tests were among a string which found no evidence of the virus. The Sunday Times also disclosed critical flaws in one apparently positive study, which involved materials supplied by Wakefield. This had misled thousands of families affected by autism, both in the UK and the US, ensnared for years in hopeless litigation based almost entirely on his measles theory.
Deer (who in April 2006 reported the first British measles death in 14 years) took no view on whether vaccines may or may not cause autism, but he never found any scientific material which repeated the Lancet findings. Although all kinds of children suffer from digestive issues, he learnt of a mass of authoritative research which overwhelmingly rebutted Wakefield's claims. "Specifically, numerous studies have refuted Andrew Wakefield’s theory that MMR vaccine is linked to bowel disorders and autism," was how the American Academy of Pediatrics summarised the position in an August 2009 statement to NBC News for a Dateline programme which featured both Wakefield and Deer. "Every aspect of Dr Wakefield’s theory has been disproven."
The impact of the investigation has been felt around the world, with media coverage from New Zealand to Canada. In the UK, the revelations prompted a statement by the prime minister, a collapse in the anti-MMR campaign, and a rebound in vaccination levels. In the US - where the Barr-Wakefield deal was joined by allegations marshalled by American attorneys that a mercury-based vaccine preservative, thimerosal, was also at fault - findings by Deer were presented by the Department of Justice in federal court, followed in February 2009 by scathing judgments. After hearing a test case of petitions from some 5,000 families, one presiding judge said: "Therefore, it is a noteworthy point that not only has that 'autistic enterocolitis' theory not been accepted into gastroenterology textbooks, but that theory, and Dr Wakefield’s role in its development, have been strongly criticized as constituting defective or fraudulent science."
Wakefield campaign denies everything
In response to Deer's findings, Wakefield supporters denied that he received money for research, and, amid a barrage of sometimes paid-for attacks, smears and crank abuse, insisted that the doctor was a champion of children’s interests. But the father-of-four had not only baselessly triggered the resurgence of sometimes fatal or brain-disabling measles outbreaks, plunged countless parents into the hell of believing it was their own fault for agreeing to vaccination that a son or daughter had developed autism, and misled an ethics committee over child rights and safety, but it was discovered that he had gone as far as to buy blood samples from children as young as four years old, attending a birthday party, and then to joke about them crying, fainting and vomiting.
Meanwhile, Wakefield bizarrely argued that he never said that MMR caused autism at all. But documents - including patents - evidence the doctor's claims, and he published a string of further misleading reports intended to undermine the vaccine. Even when he knew that his allegations had been proven baseless, he was found promoting them from a controversial business in Austin, Texas, called Thoughtful House, where, after being fired from the Royal Free in October 2001, he held a $280,000-a-year post, spun from his campaign against the shot.
Throughout the investigation, Wakefield refused to co-operate, filed complaints, and issued statements denying every aspect. He also initiated, and then abandoned with some £1.3m ($2m) costs, a two-year libel lawsuit, financed by the Medical Protection Society, which defends doctors against complaints from patients. In reply, Deer and Channel 4 accused Wakefield of being "unremittingly evasive and dishonest". His conduct in the litigation was also criticised by a High Court judge, who said that Wakefield "wished to extract whatever advantage he could from the existence of the proceedings while not wishing to progress them", and that the doctor was using them as "a weapon in his attempts to close down discussion and debate over an important public issue".
Wakefield, who contrived a bizarre conspiracy theory, says he has done nothing wrong. "The notion that any researcher can cook such data in any fashion that can be slipped past the medical community for his personal benefit is patent nonsense," he argued in a March 2009 statement. "Scientific rigor requires repeatability for verification of any research and Mr Deer's implications of fraud against me are claims that a trained physician and researcher of good standing had suddenly decided he was going to fake data for his own enrichment."
Lancet paper retracted and doctor ousted
On 28 January 2010, a statutory tribunal of the UK General Medical Council handed down rulings on Wakefield's conduct, following a 197-day inquiry, wholly vindicating Brian Deer's investigation. Branding Wakefield "dishonest", "unethical" and "callous", the panel of three doctors and two lay members found him guilty of some three dozen charges, including four of dishonesty and 12 involving the abuse of developmentally-challenged children. His 1998 Lancet research was found to be dishonest, and performed without ethical approval. Five days later, the Lancet fully retracted the paper from the scientific literature, prompting international media interest.
"What is indisputable is that vaccines protect children from dangerous diseases," said the New York Times, in one of a string of editorials to appear in world newspapers. "We hope that The Lancet’s belated retraction will finally lay this damaging myth about autism and vaccines to rest."
On 17 February, Wakefield was ousted by the directors of his Texas business, and, after further proceedings, his license to practise medicine is expected to be revoked.
Wednesday, May 12, 2010
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