| briandeer.com | THE INVESTIGATION





  The MMR-autism crisis
- our story so far


Left: British former gut surgeon Andrew Wakefield






"It has been proposed that my role in this matter be investigated
by the General Medical Council. I not only welcome this, I insist on it"
-
Andrew Wakefield, February 2004.

By Brian Deer

Immense human suffering is being exported across the world, caused by claims, born in Britain, linking the triple measles, mumps and rubella vaccine with autism.  In 2008, measles outbreaks - explicitly linked by doctors to these claims - are being reported across Europe, the United States, Canada, Australia, Japan and South Africa, as well as in the UK, where in June a 17-year-old West Yorkshire boy died, and the government's Health Protection Agency declared measles to be once again "endemic".

"Most people have forgotten, but measles was once an uncontrolled scourge that infected three million to four million Americans annually," noted the New York Times in an editorial titled "Measles returns" on 24 August 2008. "In bad epidemic years, some 48,000 Americans were hospitalized, 1,000 more were chronically disabled, and 400 to 500 died."

Today meanwhile - and no less seriously - countless thousands of mothers and fathers of autistic children are being tormented with the unwarranted guilt of being misled into thinking that they made a catastrophic mistake in agreeing to vaccination, and that [in a blame-game reminiscent of discredited "refrigerator mother" theories] they may be responsible for their own child’s disability. Young parents, in their millions, now agonize about risks whenever a son or daughter falls due for shots.

Since the early 1970s in the United States, and 1988 in the United Kingdom, the three-in-one live virus MMR vaccine has been routinely administered to almost all children, soon after they're one year old. Along with other immunisations - such as that against polio, and the combined diphtheria, tetanus and pertussis shot - MMR has become a mainstay of public health, protecting against infectious diseases.

But, now a decade ago, a UK medical journal, the Lancet, unleashed a devastating assault on confidence in the vaccine: suggesting that independent researchers had discovered a possible link with the development of a new "syndrome", combining regressive autism and inflammatory bowel disease. This startling allegation came in a five-page paper [pdf version], dated 28 February 1998, authored by Dr Andrew Wakefield, Professor John Walker-Smith, Dr Simon Murch, and ten others, based at a medical school attached to the 1,000-bed Royal Free hospital, in the Hampstead district of north London.

Media reaction at the time to these claims was swift. "A medical study suggests today that there could be a link between the measles, mumps and rubella vaccine (MMR) given to children in their second year of life and inflammatory bowel disease and autism," reported, for example, The Guardian, on page 1 of its issue of 27 February 1998. "They also found that the behavioural changes in the children which are typical of autism, such as forgetting the basic language they had just learned, began within days of their MMR vaccination."

The Lancet paper reported on just 12 anonymous children, aged 3-10, who had previously been diagnosed at other centres with a variety of developmental disorders, and who the paper said had symptoms of a variety of bowel complaints [later revealed mainly to be constipation]. These dozen kids were referred for tests at the hospital's paediatric gastroenterology unit - allegedly consecutively - in late 1996 and early 1997.

Although, in July 2007, a General Medical Council [GMC] panel began hearings into the ethical issues, the published study's principal "finding" was an alleged association between MMR vaccination and what the Wakefield group claimed to be the sudden onset of developmental disorders in eight - two-in-three - of the 12 children. This "finding", and massive publicity that the Royal Free hospital and medical school encouraged for it [through a press release, video news release and a televised press conference] launched a worldwide scare over the vaccine's safety, triggering falls in immunisation rates [for year-on-year stats see the foot of this report], outbreaks of potentially fatal or disabling diseases, and an epidemic of agonising self-recrimination among many parents of autistic children.

"Any mother who has a child wants it to be normal," said, for example, Karen Prosser, who featured with her autistic son Ryan in the hospital's video, voicing sentiments repeated many times over the years. "To then find out your child might be genetically autistic, is tragic. To find out that it was caused by a vaccine that you agreed to have done is just devastating."

But, despite its extraordinary impact - particularly on such parents - even superficial examination of the Lancet report revealed crude errors, inconsistencies and omissions, which might properly have been challenged by the journal's editor, Dr Richard Horton, a former Royal Free colleague of Wakefield's. Horton, however, vehemently supported the paper, and shrugged off mounting concerns. "Progress in medicine depends on the free expression of new ideas," he wrote in its defence, in 2003. "In science, it was only this commitment to free expression that shook free the tight grip of religion on the way human beings understood their world."

In addition to errors, inconsistencies and omissions, however, the paper was also marred by a striking departure from journal conventions over the "inflammatory bowel disease" Wakefield claimed to have discovered. This was diagnosed primarily by the appearance of multiple small bumps in the last part of the small bowel - technically named ileal-lymphoid nodular hyperplasia - which represented an activation of the local “immune tissue” frequently seen in normal children, and by what he and his associates claimed was "non-specific colitis" [in the large bowel]. But, although the report was, in fact, titled "Ileal-lymphoid-nodular hyperplasia, nonspecific colitis, and pervasive developmental disorder in children," nowhere did it discuss, or even cite previous literature on, the key phrase: "ileal-lymphoid-nodular hyperplasia".

Such shortcomings - and a principal finding concerning the sudden onset of behavioural disorders in the children which was, at face value, unbelievable - caused widespread concern among those who understood the paper, and alerted Brian Deer [pictures] [British Press Award] to the need for an investigation. This was eventually instigated, in September 2003, by editors of The Sunday Times of London. [See The Sunday Times reports listed]

The Lancet paper

Following Brian Deer's investigation, and charges laid against Wakefield, Walker-Smith and Murch by the General Medical Council, numerous of the Lancet authors would deny that the paper was ever about MMR at all. But the text, tables and references were all thick with issues concerned with the vaccine, and the paper's most important passage - the "findings" - stated:

Findings. Onset of behavioural symptoms was associated by the parents with measles, mumps, and rubella vaccination in eight of the 12 children...”

In the no-less-critical “results” section, the paper elaborated on the findings, alleging an extraordinary 14-day timeframe:

“In these eight children the average interval from exposure to first behavioural symptoms was 6.3 days (range 1-14).”

It was this purported "finding" and "result" - suggesting that the Wakefield group may have stumbled upon evidence of a potential health disaster - that set off the worldwide MMR scare, which has caused parents anxiety ever since.

With medical research increasingly dominated by the agendas of drug companies and other commercial interests, the reported study drew particular strength from its apparently independent support. Under a customary section for such papers headed “acknowledgements”, it said:

“This study was supported by the Special Trustees of Royal Free Hampstead NHS Trust and the Children’s Medical Charity.”

No other source of support was cited, although the charity, which had been set up to fund experiments with vitamin B12 at another London hospital, had ceased operations in 1995 due to an ethics and publication controversy.

It also appeared from the text that Wakefield and his colleagues had complied with the Lancet's editorial requirements with a declaration on institutional oversight. Under the heading “Ethical approval and consent”, the paper said:

“Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent.”

Authoritative biomedical journals will not accept for publication research involving human subjects without statements of such a nature.

Finally, in the paper's pivotal conclusions section [known in the Lancet and many other biomedical journals as the "interpretation"], the authors summarised their purported findings:

Interpretation. We identified associated gastrointestinal disease and developmental regression in a group of previously normal children, which was generally associated in time with possible environmental triggers.”

Brian Deer’s Sunday Times findings

The paper suggested that the eight children whose parents were reported as blaming MMR were merely routine referrals from general practitioners and hospital doctors to the Royal Free's paediatric bowel unit. Under the heading "patients and methods", it stated:

”12 children, consecutively referred to the department of paediatric gastroenterology with a history of a pervasive developmental disorder with loss of acquired skills and intestinal symptoms (diarrhoea, abdominal pain, bloating and food intolerance), were investigated.”

But The Sunday Times investigation unearthed a different story, which left the integrity of the research in ruins. Long before publication, almost all of these children [through their parents] were actually clients and contacts of a small-time UK solicitor, Richard Barr, who had been attempting to raise a speculative lawsuit - financed through the British government's legal aid fund - against drug companies which manufactured MMR.

Although doomed from the outset to fail [as all previous such actions in the UK against drug companies have failed], this lawsuit was the origin and engine of the MMR scare: both in Britain and throughout the world. First spun from publicity surrounding the UK government's withdrawal in September 1992 of an early version of MMR [due to the mumps component being linked with rare cases of viral meningitis], it quickly evolved into a fishing expedition for any allegation critical of the vaccine.

Vaccination rates were unaffected by by the 1992 withdrawal, and there was no wider public alarm. But a campaign was started by a Wigan housewife, Jackie Fletcher, alleging a link with developmental disorders - but not autism, at this time - one of which afflicted her son, Robert Fletcher. With such disorders still poorly understood, and with problems typically manifesting at around the age of routine vaccination, alarmist media suggestions of a link with MMR became amplified like pyramid selling. And, as Barr's name got around as the "MMR lawyer", his key clients, led by Fletcher, began a campaign to deploy frightening, but generally unverified, "mother and child" vignettes: winning new converts to the litigation. Eventually this would register 1,600 claimants, all of whom have since discontinued.

Barr's early efforts ran along similar lines to failed legal claims, mounted in Britain during the 1980s, over the triple diphtheria, tetanus and pertussis [DTP] vaccine. Those claims involved [subsequently discounted] allegations that DTP sometimes caused permanent brain damage to children - and specifically [albeit rather arbitrarily] within 14 days of vaccination. The same time-frame - 14 days - was also tabulated in a landmark 1981 British epidemiological survey, the National Childhood Encephalopathy Study, which not only included data concerning events after DTP, but also after the administration of single measles vaccine.

But Barr - working with assistant and future wife Kirsten Limb - had no medical or scientific experts to mount a similar attack on MMR. The mumps meningitis cases appeared to resolve without long-term problems for sufferers, and [although drug industry lawyers would later express amazement that no serious legal challenge was raised with respect of vaccine products withdrawn on government orders] any serious side-effects were evidently so rare that they couldn't offset the advantage of vaccination. The risk-benefit profile of the triple shot seemed clear, and Barr's lawsuit looked likely to founder.

In 1995, however, the position changed, with the emergence of Andrew Jeremy Wakefield, a former gut surgeon doing research at the Royal Free medical school. The son of a prosperous neurologist father and general practitioner mother, from the west of England town of Bath, Wakefield was ambitious and was determined to make his mark. And, although employed full-time at the school since November 1988, he'd already developed a taste for business ventures, registering private companies from external addresses, and filing patents on work done at the school.

The most bizarre was "Wakefield's box": an "apparatus and process for performing a chemical reaction", filed with the London patent office in December 1993. This was a cabinet, fitted with microwave heater and fan system, to heat and cool materials for experiments.

Target was Crohn's disease

But Wakefield nurtured a more ambitious "big idea": that he had discovered the cause of Crohn's disease. This terrible, and sometimes even fatal, inflammatory bowel disease, is a major medical mystery, with numerous theories as to why some people get it. The gut surgeon's speculation was that it was caused by measles virus, and in March 1995, he patented this claim, from his home address, without the knowledge of the medical school, his employer. So if this virus - specifically involving live strains in vaccines - caused Crohn's, there were prospects of him garnering fame and wealth.

Speculations abound in medicine about diseases of unknown cause being the result of common infectious agents. They almost always turn out to be wrong. But in October 1992 - just two weeks after the mumps meningitis problem had triggered the withdrawal of two brands of MMR - Wakefield began phoning and writing to officials at the department of health in an extraordinary, almost menacing, tone. Although the brand withdrawals were over mumps, not measles virus in the vaccine, and he was only a lecturer at a north London medical school, he demanded top-level meetings, and for his work to be government-funded, with veiled suggestions about media involvement.

"My concern is that although measles, and in particular the vaccine may have no association with Crohn's disease whatsoever, what will be picked up by the press is the apparent association between the increasing incidence of disease and the vaccine," he wrote to Dr David Salisbury, chief of the vaccine programme.

Two-and-a-half years later, Wakefield made good on this warning when in April 1995 [one month after filing his Crohn's patent application] he held a press conference at the Royal Free hospital. This event announced the publication - also in the Lancet - of a low-grade, much-challenged statistical paper, seeking to mine some kind of epidemiological association between vaccine use and in the incidence of Crohn's. He appeared on television and in newspaper reports. These caught the lawyer's eye.

"Children who have been vaccinated against measles are three times more at risk of developing serious bowel disease in later life, a study suggests," reported Daily Mail journalist Jenny Hope, in publicity from the Crohn's press conference. "Dr Andrew Wakefield, of the Royal Free Hospital School of Medicine in North London, said the increased risk could be due to the use of live virus."

It was this 1995 publicity which first caused the public to become concerned about MMR. And, although Wakefield would subsequently repudiate his theory, his first forays into autistic children was to prove the cause of Crohn's. Although some parents would believe that he was a champion of families struggling with autism, evidence later presented to the General Medical Council suggests that this was initially far from the case. He simply wanted to get into the guts of children - any children might do it - to prove that measles virus persisted. But such research on healthy kids would never be permitted: it would be unethical to expose them to the risks. Through Barr, however, he saw an unparalleled opportunity: to perform the tests on those with brain disorders. These uniquely vulnerable children of Barr's desperately worried clients might thus allow the research to go ahead. As Prof John Walker-Smith would later tell the GMC:

"The heart of the matter - this all began with Dr Wakefield's idea that Crohn's disease was triggered by MMR, and measles was the important factor."

Wakefield's theories on Crohn's, however, proved a road to nowhere: even criticised by the Royal Free medical school. But, evidently on the principle that "my enemy's enemy is my friend", Barr and Wakefield made common cause against MMR: bolting together a novel, elaborate, unsubstantiated [and by 2008 comprehensively refuted], speculation that measles virus in the vaccine somehow damaged the gut, which somehow released so-called "opioid peptides" from food into the bloodstream, which somehow damaged the brain.

Although the 1998 "MMR" Lancet paper remained silent on other pivotal matters, this "opioid excess theory" of autism - which has since been established to be false in all respects - was set out in surprising detail. In a customary section for biomedical texts headed "Discussion", for example, Wakefield recounted how a number of [fringe] sources [not all of whom were even doctors or scientists] argued that autism could arise from digestive problems:

"The 'opioid excess' theory of autism, put forward first by Panksepp and colleagues, and later by Reichelt and colleagues and Shattock and colleagues proposes that autistic disorders result from the incomplete breakdown and excessive absorption of gut-derived peptides from foods, including barley, rye, oats, and casein from milk and dairy produce."

As an explanation for autism, however, the theory was absurd: an almost Christmas cracker level of science. Although not taken seriously enough by scientists to be publicly nailed until authoritative research was published in March 2008, it had first been set out in July 1979 in a fringe "point of view" article by a psychologist, Jaak Panksepp. Without any clinical evidence whatsoever, but rather based on observations of rats, this article began:

"We have approached the possible neurochemical causes of autism by assuming that the fundamental problem of the autistic child is emotional. Some of the earliest observed symptoms of autism include a lack of crying during infancy, a failure to cling to parents, and a generally low desire for social companionship, which, we believe, shows that the autistic child is constitutionally unable to feel properly the emotions arising from social relationships. Injections of low doses of morphine can generate such behaviour patterns in animals..."

Although such views were laughable, other possible mechanisms by which the vaccine might cause autism were shunted to one side. And as hundreds of parents of disabled children joined the lawsuit - with all the uncertainty and stress that litigation always brings to people's lives - this would be a vital link in the purported chain of causality to be set out in the legal claims. Here's a typical paragraph, for example, from documents later submitted by Barr to the High Court:

"In susceptible children, the presence of measles vaccine viral material in the tissues of the gut causes immune dysregulation and/or immune reactions and/or autoimmune reactions which cause or materially contribute to the development of an inflammatory bowel disorder, which in turn initiates a biochemical cascade and in turn leads to the egress of products of digestion and neuroactive/neurotoxic agents (including an excess of opioid peptides) into the circulation damaging the brain so as to cause autism/an autistic spectrum disorder."

But the key to the strategy was to find concrete examples: test cases to be tried in court. Since any vaccine-damaged individuals have no known distinctive physical or behavioural features, it was essential to Barr's lawsuit [Sayers & Ors v SmithKline Beecham & Ors] to propose a fingerprint of damage. So, in February and June 1996, Barr wrote to [possibly hundreds of] his MMR clients and contacts - overwhelmingly people who'd got in touch with him following publicity for his campaign - and advised them that those whose children had any of a list of possible symptoms of Crohn's disease [such as bouts of diaorrhea, gut pain or even mouth ulcers] should contact him for possible referral to Wakefield.

It was a means of finding subjects for Wakefield's research, but, by selection, created a false impression. Using recruitment methods never publicly disclosed before Brian Deer's investigation, the appearance of a potential link between [1] MMR vaccination, [2] bowel problems, and [3] autism, was artificially created by soliciting and sorting from a larger group of children, recruited from publicity, a small number in whom all three issues coincided. Logically, it was like selecting vaccinated kids with developmental disorders and rotten teeth, and sending them to a dentist who offers the opinion that vaccination causes caries, leading to autism.

Legal aid contract

The risk of creating a spurious connection was obvious. But Barr had made up his mind. "Needless to say both Kirsten and I are satisfied that the link between vaccines and the injury to our individual clients is not a fanciful one, but one of direct causation," he wrote in June 1996. "Unfortunately the experience of many of our clients is that even in the face of quite an obvious link between the vaccine and the injury, doctors are dismissive and say that the cause is anything but the vaccine."

While Barr appealed to his clients for symptoms, he helped Wakefield draft a proposal to the British government's Legal Aid Board to pay for him to prove his theory. Attaching a copy of a Royal Free research protocol - later filed with the hospital's ethics committee - the two men submitted to the board detailed costings for procedures, and a statement of Wakefield's intentions. In terms devastating to any possible claim that Wakefield was employed to be an independent scientist pursuing objective research, before any of the children were admitted for his project, or even seen at the hospital as outpatients - and more than 18 months before the Lancet paper was published - they wrote:

"It is hoped that using the testing protocol attached it will be possible to establish the causal link between the administration of the vaccines and the conditions outlined in this proposed protocol and costing proposals. The standard of proof aimed for will be at least the balance of probabilities but it is hoped that in many respects the level of proof will reach certainty or near certainty."

So seriously did these preparations for the lawsuit impact the Lancet study published in February 1998 that, even before the last of the 12 children was admitted to the hospital for Wakefield's research, the parents of six had already been issued with legal aid numbers through Barr's then-law firm, Dawbarns of Norfolk. Moreover, even before the last child in the series was admitted to the Royal Free, [one year before the paper was published], Walker-Smith knew that the study was contaminated. On 20 February 1997, he wrote to Wakefield, in a letter marked as copied to Murch:

"It is clear that the legal involvement by nearly all the parents will have an effect on the study as they have a vested interest... I would have been less concerned by legal involvement if our work were complete and we had a firm view. Never before in my career have I been confronted by litigant parents of research work in progress. I think this makes our work difficult, especially publication and presentation."

In the event, at the date of publication, the parents of ten of the children, whose anonymised apparent details were included in the paper, had legal aid to sue manufacturers. One more was American, and therefore not entitled to sue. And the mother of the twelfth eventually changed her mind - four years after going to the hospital - and blamed MMR for her child's neurological problems, after she was visited at home by a lawyer.

Wakefield and Barr were working together. But third parties were also key. In addition to being lawyer's clients and contacts, parents arriving at the Royal Free to vocally accuse the vaccine of causing developmental disorders were members or contacts of the British campaigning organisations JABS and Allergy-Induced Autism: both run by Barr clients [respectively Jackie Fletcher and Rosemary Kessick], who were collaborating with Wakefield behind the scenes. No wonder that, eventually, the parents of all 12 - an incredible 100% - of the Lancet children, who Wakefield repeatedly held out to the world as being nothing more than consecutive, routine clinical referrals to the paediatric bowel unit of the hospital [which didn't even boast a reputation as a centre for developmental disorders], were on the record as blaming MMR.

None of this underbelly was revealed in the paper, or reported in surrounding publicity. Although the Lancet text opaquely referred to possible "selection bias in a self-referred group", this possibility was dismissed in the same sentence, and nowhere was the children's extraordinary status and manner of recruitment disclosed. Rather, Wakefield misled the public by laundering into the medical literature, as apparently scientific findings and results, what were, in reality, highly-motivated [and usually poorly-substantiated] allegations from a group of parents who had an overpowering emotional and economic need to believe that MMR was at fault.

The apparent parental allegations, moreover, were written up in terms that misled. Where Wakefield spoke in the paper of behavioural symptoms within 14 days of MMR, the true position was that the parents [usually after advice from lawyers or activists, and always after being advised by Wakefield] had generally reported [if anything] common, benign, consequences of vaccination, such as crying, fever, rash, irritability, and even sometimes [also benign] febrile convulsions. No competent doctor, acting professionally, could describe these as "behavioural symptoms", much less hold them out as potential markers for the onset of regressive autism.

In fact, Wakefield's tabulated finding - linking MMR with the sudden onset of regressive autism in two thirds of a consecutive series of 12, seen routinely at a children's bowel unit within the space of a few months - was both biologically implausible and statistically impossible. It simply could not happen.

No paper or article has ever subsequently been published proposing anything like this scenario. Indeed, faced by urgently-commissioned research, and a review of cases by the Committee on Safety of Medicines, which showed no such temporal association, the lawsuit-driven anti-MMR campaign moved off in a different direction. The argument quickly changed to allege that the emergence of autistic disorders after MMR wasn't sudden at all, but delayed and insidious. By August 2001, other retained experts, working for Barr, led by Canadian epidemiologist Walter Spitzer and British psychologist Kenneth Aitken, published a paper reporting, among other things, that they'd found only two out of 493 [0.4%] children then enrolled for Barr's lawsuit [who were vaccinated between January 1988 and November 1998, and thus including Wakefield's series] where MMR had been given less than 30 days before the appearance of behavioural symptoms. In striking contrast, however, Wakefield had claimed in the Lancet paper that eight out of 12 [66.6%] had received MMR within 14 days of symptoms. Moreover, Spitzer and Aitken reported that the median time to the onset of symptoms among Barr's clients was 1.1 years, while Wakefield had claimed a median time of only 6.3 days.

Wakefield's "finding" and "result" were thus abandoned by history, with only the sting of his attack remaining. In due course, he would up the stakes, issuing a string of false claims, including baseless comparisons between California and London autism data, published with a Royal Free sidekick Scott Montgomery Ph.D in November 1999, again in the Lancet, falsely claiming that MMR was responsible for an epidemic of autism. Then, in January 2001, the pair published a sham review of vaccine research, in Adverse Drug Reactions and Toxicological Reviews. Analysis of these texts reveals Wakefield's motive: to attack MMR, with little heed for truth or consequence. But, with regard to the February 1998 Lancet paper, his claims were a charade: by a former surgeon with insufficient training in general medicine and paediatrics to realize that what he'd claimed was impossible.

It was a similar kind of story with the "inflammatory bowel disease" Wakefield claimed to have discovered. Later, he would grandly dub this "autistic enterocolitis", as if it were something distinctive to these children. Even the British Medical Journal, attending the launch of the Lancet paper in 1998, took this to be a pivotal insight. "The study is the first of five new papers to be published on the new syndrome, which the team have named ileal lymphoid nodular hyperplasia," the journal reported on 7 March 1998.

But within weeks of the Lancet paper's publication, the clinicians admitted that they'd seen something else: very common both to children with developmental disorders, and to those with learning difficulties. "Plain radiography confirms severe constipation with acquired megarectum [solid blockage] in almost all affected children," Walker-Smith and Murch wrote in a letter to the journal, published on 21 March 1998. "Most parents note a honeymoon period of behavioural improvement after the bowel preparation for colonoscopy and this is maintained if recurrent constipation can be prevented."

"Constipation" was nowhere mentioned in the paper, but was this related to the ileal-lymphoid hyperplasia? In fact, this term [meaning swelling of glands near the end of the small intestine, near the appendix] didn't refer to an "inflammatory bowel disease" at all, but to a common gut feature, often seen in children, regarded by specialists as usually benign. Although, oddly, the Lancet paper contained no explanation, discussion or literature citations whatsoever about this feature, even a panel of 20 specialists, including Wakefield and his supporters, convened in October 2006 by a US group, Autism Speaks, concluded:

"The clinical significance of LNH in children with autism is unclear given that similar findings have also been reported in children with typical development as well as children with food allergies and immune deficiencies."

Besides lymphoid-nodular hyperplasia being a frequent, benign finding in all kinds of children seen at hospitals - and not, as Wakefield had claimed, a new disease linked to autism - Walker-Smith would later admit in confidential papers that most children that he claimed to have "autistic enterocolitis" didn't have enterocolitis [meaning inflammation of both the large and small intestines] at all. And experts also found "unremarkable" signs in the children's colons. "These colonoscopic findings of increased vascularity and granularity are entirely subjective," wrote one experienced gastroenterologist in a report. "These are appearances that can occur following bowel preparation for colonoscopy and they are of no diagnostic significance."

No wonder that, in September 2003, Barr's lawsuit collapsed, when public funding was stopped, immediately following expert reports being exchanged between the parties. Although Fletcher's JABS group would blame the government, the Legal Services Commission, the judiciary, and even Brian Deer [who at the time had never published anything whatsoever about MMR] for the failure, it was the children's own lawyers - the QCs Jeremy Stuart-Smith, Simeon Maskrey and Augustus Ullstein - who had advised the commission that, notwithstanding the vast investment of public money in trying to undermine MMR, the attack based on Wakefield's theories was unlikely to succeed. As Lord Justice May summarised the events, in a February 2006 appeal court judgment:

"The actions proceeded and expert evidence was exchanged. At this stage, three leading counsel for the claimants in the group action produced a lengthy advice. They advised that, as the evidence stood, there was no reasonable prospect of establishing that the MMR vaccine could cause ASD."

Ten years had been wasted on Wakefield's claims. Parents had gained nothing but heartache.

He who paid the piper...

To understand Wakefield's conduct, it's hard to overlook his hidden financial interests. To the later declared surprise of his colleagues [mp3 audio], two years before the Lancet paper was published, his research on the children had begun, not just with a desire to collaborate with Barr, but with a lucrative financial contract to join the team preparing the lawsuit. In February 1996, Wakefield agreed to work for Barr at a rate of £150 an hour - a great deal of money for a retained expert at that time - in addition to his Royal Free salary. And as the Sunday Times investigation revealed in February 2004, the proposal submitted to the Legal Aid Board [now the Legal Services Commission] in June 1996 meant money to support Wakefield's work.

Shunning competing explanations for how MMR might cause injuries, and without any medical or scientific review, Barr was authorised to pay Wakefield a maximum of £55,000 from public funds - on top of his hourly rate - to perform the research in the June 1996 proposal. This was to provide for "clinical and scientific" tests on ten client children in the hunt for evidence for the lawsuit. Interviewed by Brian Deer in 2004, Barr - by now working for the larger law firm Alexander Harris - confirmed that he'd arranged finance [mp3 audio] for the study published in the Lancet of February 1998. But then, after public uproar followed the first Sunday Times reports, he avoided any further comment.

Even some of Wakefield's closest collaborators voiced concern over this new information. "We were shocked by the revelations in the Sunday Times," said Professor John O'Leary, a controversial Dublin-based Wakefield associate, and former business partner, in a statement issued through his lawyer. "We were not made aware, nor were we aware, of any liaison between Dr Wakefield and Mr Richard Barr of Alexander Harris Solicitors that apparently existed since 1996. In addition, we had never been informed that the LSC had funded Dr Wakefield."

Walker-Smith also denied all knowledge, despite being the study's senior clinical investigator. In an email, circulated at the Royal Free on 27 February 2004, in response to The Sunday Times investigation, he said:

"No financial details of Andy's work was ever discussed with me by anyone and I was totally unaware of the grant of £55,000 that had been paid to him in an NHS Trust Fund, until Deer told me to my astonishment in December 2003."

The explosive revelation about Wakefield's £55,000, however, only scratched the surface of his pecuniary advantage. On the legal front, in December 2006, the Legal Services Commission answered a Freedom of Information Act request from Brian Deer with a spreadsheet of fees to paid witnesses in the MMR lawsuit, stating that, since joining Barr ten years previously, Wakefield had been paid £435,643 [about $780,000], plus expenses, for his role in backing the generic case against MMR. This money - which is believed to have been augmented by yet more, still undisclosed, for work on individual children's records - was drawn against the cash-limited UK legal aid fund, intended to help poor people gain access to justice. During this period, Wakefield and his wife built a house on land purchased adjacent to their home, which was offered for sale in March 2007 priced £2,950,000 [$5,677,550].

Like many biomedical journals, the Lancet had strict rules requiring authors to report potential conflicts of interest. But neither the nature of the collaboration with Barr, the money Wakefield received, nor the children's litigant status, were disclosed to the journal and its readers. Nor did Wakefield reveal the true situation when repeatedly offered the chance. In March 1998, for instance, at a meeting convened by the UK Medical Research Council, he was asked where he got the children. The minutes of the exchange accurately reflect a full transcript, in Brian Deer's confidential possession:

"Members were interested in how the children had come to be referred to the RFHMS team, as this had a bearing on the issue of bias in the generation of the case series. Mr Wakefield explained that originally the parents of the children had come to the group without any connection through any other organisation. Latterly, following media attention, parents had heard of the RFHMS group's work either directly or through other organisations. All patients who had been reviewed to date had been referred by their general practitioner or paediatrician by the standard route."

In May 1998, two months after this meeting, the Lancet published a reader's letter speculating that lawyers were involved [pdf version]. Then, in April 2000, Wakefield was asked at a US congressional committee, with reference to material he'd presented, which included the Lancet 12:

"Who funded your study?"

And, in March 2001, he was asked again at an Irish parliamentary committee to identify the source of his finance. When Wakefield dodged the question, a deputy pressed him:

"I genuinely wanted to know who is funding the research."

On any of these occasions, Wakefield might have made the position clear: that a lawyer employed him to produce evidence against the vaccine.

Ethical issues

The Sunday Times investigation also revealed anomalies over the project's institutional review. Under the terms of the Declaration of Helsinki of June 1964 [with later revisions], and other rules, such review is an essential prerequisite to research on humans: aiming to protect the rights of subjects, to prevent exploitation of the vulnerable - especially children and the mentally incapacitated - and to ensure that the true facts [including sources of funding and subjects] are independently approved as ethical. The spur to the declaration were abuses by Nazi doctors, exposed after the World War II. Other 20th century atrocities included the Tuskegee syphilis experiment, which saw infected black men left untreated.

But after the Lancet report was published, its claim that “investigations were approved by the Ethical Practices Committee” was questioned by a senior British doctor, and denied both by the chair of the Royal Free's ethics committee, and by the dean of its medical school. In fact, the committee had challenged Wakefield and Walker-Smith in 1996 over the purpose of their investigations, which included a battery of hazardous, invasive procedures of questionable clinical justification. These procedures were set out in two protocol documents describing the clinical and scientific research to be undertaken, titled "A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination". One of these documents was a 20 page narrative, outlining the proposed project. The other was an ethics committee question-and-answer pro-forma of 11 pages, completed and signed by the researchers.

After written and verbal questions to Wakefield and Walker-Smith, the ethics committee was led to believe that the procedures to be undertaken - including general anaesthesia, ileocolonoscopies, MRI brain scans, EEGs, and even lumbar punctures - were merely routine clinical evaluations, which would have been carried out even if there had been no study. But, in fact, they were part of the regime specified in the deal that Wakefield had reached with Barr. Having been set out in a research protocol and proforma [which, oddly, spoke of an alleged "new syndrome" in advance of any research], moreover, the procedures were determined before children were even seen at the hospital, much less had their individual histories, symptoms and signs evaluated by appropriate doctors.

Years later, at the General Medical Council hearing in 2007 and 2008, the doctors would claim under oath that the investigations were all clinically-indicated, with decisions to perform them taken after the children were examined at the hospital. But in January 2004, prior to the GMC's charges being laid, Brian Deer had interviewed Dr Simon Murch, who clearly recalled the decisions to perform the procedures being taken before, as part of a research exercise. By agreement, the interview was recorded.

BRIAN DEER: “So up front somebody had a rubber stamp that said they’ll all have MRIs et cetera.”

SIMON MURCH: “Exactly.”

Murch added:

“We had meetings, and in our research planning meetings we had all these referrals, and we felt that they - having seen the few we had taken  histories from - they had had no investigations. The doctors’ label applied.  One or two had been investigated at the time, but this was, ‘Okay, how are we going to do this properly?’  And so that was a prospectively-planned research to do a defined number of children, just in terms of assessing the limits of what we were having.”

He was in no doubt, moreover, that the study was ethically approved. Deer read him the ethical statement in the Lancet - "Investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust, and parents gave informed consent - ” and then continued.

BRIAN DEER: “Do you believe that to be true?”

SIMON MURCH: “Yes.”

BRIAN DEER: “You believe it’s true?”

SIMON MURCH: “I do.”

BRIAN DEER: “You believed it then, and you believe it now?”

SIMON MURCH: “Yes.”

BRIAN DEER:“Investigations?”

SIMON MURCH: “Yes. The ethical thing, that was approved for those 12 children. We did not go on doing lumbar punctures, and we haven’t done that since. That was for that initial assessment study. Yes, absolutely."

A month after this interview, Simon Murch, on behalf of the Lancet authors, Prof Humphrey Hodgson, on behalf of the Royal Free and University College medical school, and Dr Richard Horton, on behalf of the Lancet, all took the same stance, and issued formal statements insisting that ethical approval was given for the work published in the journal, according to the protocol documents submitted in 1996, and extensively discussed in 1997. Wakefield made the same claim in a letter to The Sunday Times. But, despite all these considered written assertions, after the disciplinary charges were laid against them by the GMC, Wakefield, Walker-Smith and Murch would change their story, repudiate their claims of 2004, and claim that no research study was ever carried out on the children, and hence no approval was required.

In fact, as documents obtained during Deer's inquiries revealed, the committee never approved any study as described in the Lancet of February 1998. A comparison between the project submitted to the committee - involving proposed research on 25 patients diagnosed with the very rare and serious childhood disintegrative disorder [and with what Walker-Smith told the committee was a "hopeless prognosis"] - was quite different to the eventual report on only 12 children afflicted by vastly more common and disparate developmental disorders, which couldn't responsibly be described as "hopeless". These disorders not only included autism, but [although not revealed as such in the paper] also the "high-functioning", non-regressive, Asperger's syndrome, and even pathological demand avoidance.

Moreover, in a stipulation commonly laid down by ethics committees, the Royal Free's ruled that any children enrolled into Wakefield's research prior to the completion of ethical consideration in December 1996 [which was 7 of the 12 reported in the paper] must be excluded from the study. Had this ruling been heeded [which it wasn't], the apparent results of the research would have been substantially different to what was published: embracing many children where a vaccine link was implausible, or where there was manifestly no claim of anything like the sudden onset of regressive autism. Compliance would have torpedoed the 14-day temporal link, and the health scare would have been scuppered.

Dr Michael Pegg, chair of the Royal Free's ethics committee, was interviewed by Brian Deer in 2003. “If somebody tells me something, I have to believe them,” he said of the submissions made to him regarding the Wakefield project.  “If what I am told is not correct, that is a problem for others, the General Medical Council and so on.”

The unreliability of the Lancet data was emphasised in 2005, when Deer obtained a previous version, showing that Wakefield had sexed-up his findings. Side-by-side, the two texts report dramatically different results from the same records of the same 12 subjects. One child's bowel, for instance, moves from normal to abnormal in a simple, manual alteration. The most striking change, however, concerns the 14-day time-frame, which morphs from one version to the next. In a version circulated at the Royal Free in August 1997, 14 days is cited as the average time to the onset of "behavioural symptoms", with the maximum time [range] stated to be 56 days. In a second version, eventually published, however, the 14-day time-frame survives, but now as the maximum, with the reported average just 6.3 days.

Parents - desperate for answers, and understandably hoping for financial help to care for their children - consented to Wakefield's project. But, in some cases, their children underwent distressing, painful tests, or were even injured during futile procedures. For instance, the mother of one of the Lancet 12 - a 7-year-old boy - said that her son was rushed by emergency ambulance from his home to the Royal Berkshire hospital after enduring lumbar puncture under general anaesthetic at the Royal Free.

Later, during an extension of the project into a larger number, a second child, aged 5, was obliged to undergo emergency transfer from the Royal Free to Great Ormond Street hospital after his bowel was punctured in 12 different places during a colonoscopy. In December 2007, this boy was awarded £482,300 after the High Court was told that he'd suffered multiple organ failure, including kidney and liver problems, and neurological injuries. In allegations denied by the hospital, the boy's parents are reported to have claimed that the colonoscopy - not involving Wakefield - was "not clinically indicated or justified", that they were not given proper informed consent, and that the procedure was an "assault" on their son.

Dispatches: MMR - What they didn't tell you

After the initial Sunday Times reports, published on 22 February 2004, and followed by numerous others in the paper, the UK's Channel 4 Television network asked Brian Deer to continue his inquiries. These resulted in further revelations in a prime-time Dispatches documentary MMR: What they didn't tell you, broadcast on 18 November 2004, and described in the British Medical Journal as "one of the most exciting examples of investigative television journalism you will ever see".

The programme's findings took The Sunday Times investigation into new areas of inquiry. Instead of focusing on the legal money and conflicts of interest, Deer probed other aspects of Wakefield's secret agenda, and dug into the basis of his science. Although Wakefield's associates, business partners and collaborating parents uniformly declined to co-operate with the programme-makers, in no instance was any evidence unearthed suggesting that his claims had merit.

At the press conference on 26 February 1998, called to launch the Lancet paper, Wakefield had urged parents to boycott MMR in favour of single shots against measles, mumps and rubella, separated by gaps of one year. "It's a moral issue for me," he said. "I can't support the continued use of these three vaccines, given in combination, until this issue has been resolved."

Although Wakefield had performed no clinical research upon which to credibly base such a recommendation, this attack on MMR had been orchestrated through a 20-minute video news release, prepared weeks in advance and issued to journalists by the Royal Free hospital's press office. In this video, which doctors knew was likely to cause public alarm, and damage to immunisation rates, Wakefield four times claimed that single shots were likely to be safer than MMR, which he said should be withdrawn by the government.

In the videotape, which the Royal Free refused to release to Channel 4, but which Deer's team obtained nevertheless, Wakefield said:

"There is sufficient anxiety in my own mind of the safety, the long term safety of the polyvalent - that is the MMR vaccination in combination - that I think that it should be suspended in favour of the single vaccines, that is continued use of the individual measles, mumps and rubella components."

This call had no scientific basis. As Wakefield would later admit during an interview for an online presentation by London's Science Museum, he didn't know himself how to justify it. In a text, submitted for his approval before being posted on the web in June 2003, museum staff asked about his call for single vaccines. "What's his reasoning?" they asked.

He said:

"It's purely empirical - we have no idea. It's the public health people's job to look into that."

Wakefield's call in 1998, however, had created the false impression that it was backed by the "findings" in The Lancet of 28 February. And it fitted Barr's strategy for pursuing the litigation - which was rooted in UK consumer legislation, focused specifically on combined vaccine products. As a confidential Barr newsletter, sent to the lawyer's clients, explained in May 1997:

"If the MMR vaccines are withdrawn, then that of course will be a great leap forward for the cases."

Wakefield worked for Barr, but there was an even greater self-interest than the enormous fees he claimed from the lawsuit. Unknown to the public prior to the Dispatches investigation, nearly nine months before the press conference, Wakefield and the Royal Free medical school had filed the first in a string of patent applications for extraordinary products which could only have stood any chance of success if MMR's reputation was damaged. These included, firstly, a single vaccine against measles - a potential competitor to MMR - and, secondly, purported remedies, perhaps even what Wakefield bizarrely called a "complete cure", for both inflammatory bowel disease and autism.

One example of Wakefield's claims was found in a document filed with the London patent office on 6 June 1997, but never disclosed prior to Deer's programme:

"I have now discovered a combined vaccine/therapeutic agent which is not only most probably safer to administer to neonates and others by way of vaccination, but which also can be used to treat IBD whether as a complete cure or to alleviate symptoms."

These commercial interests - which Wakefield privately bragged would make millions - were based on a fringe technology, devised by a disgraced American doctor, Hugh Fudenberg, who made bizarre claims when interviewed by Brian Deer in Spartanburg, South Carolina. Fudenberg said that he treated autistic children using a powdered "transfer factor" remedy, which he explained that he rolled out in a sheet, three molecules deep, "like pasta", on his kitchen table. The broadcast portions of the interview were strange enough, as the following exchange reveals:

BRIAN DEER: "Now using this technology, do you believe that autism can be cured?"

HUGH FUDENBERG: "Yes."

BRIAN DEER: "Cured?"

HUGH FUDENBERG: "Yes... It's cheap, it's oral. No injections. One pill a day, every other day for three, six, months."

BRIAN DEER: "And where does that come from?"

HUGH FUDENBERG: "From my bone marrow."

BRIAN DEER: "From your own personal bone marrow?"

HUGH FUDENBERG: "Yeah."

Despite such oddities in Wakefield's scientific collaborations - including joint patents with Fudenberg for rights over possible miracle cures for autism - the former gut surgeon started his own private company, Immunospecifics Ltd [intended to be a subsidiary of another company, to be called Carmel Ltd, after his wife, Dr Carmel O'Donovan], involving collaborators John O'Leary, Robert Sleat, and Roy Pounder. This was intended to make a fortune from "diagnostic kits" to be sold off the back of the self-same litigation that he was promoting. Had these fantastic ambitions been known about before Deer's programme, Wakefield's then six-year-old crusade against MMR would surely have been interpreted differently.

And what of the integrity of Wakefield's scientific discoveries? These, too, were investigated for Channel 4. His theory, invoked to justify what would become a sustained worldwide campaign against the vaccine, was based on an unsubstantiated claim that the ultimate culprit - both for inflammatory bowel disease and the children's autism - was measles virus in MMR. Wakefield led parents to believe that it was this virus, purported to persist in the gut, which caused the damage that could lead to autism. He then joined fringe US-based businesses, such as the International Child Development Resource Center & Good News Doctor Foundation, in Florida, which sold expensive, unproven products, and unusual medical services, purporting to offer children relief.

Yet, as he'd sat at the London press conference in 1998 and triggered the public panic, Wakefield knew that his own laboratory at the Royal Free had used sophisticated molecular technologies [RT-PCR and NASBA] to test the children whose cases he presented in the Lancet as evidence of his claims. Those tests, which were executed under his personal supervision, but, yet again, never reported before Brian Deer's investigation, found no trace of measles virus [or mumps and rubella viruses] in any of the children involved.

This information was confirmed by Dr Nicholas Chadwick, who was Wakefield's personal research assistant, and who tested samples taken from the children. Chadwick would later give evidence in US court hearings, but spoke for the first time publicly on the subject to Deer.

BRIAN DEER: "And are these children the same children that went on to be published in the Lancet, leading to the MMR scare?"

NICHOLAS CHADWICK: "Yes, that's right."

BRIAN DEER: "Did you find measles virus in those children?"

NICHOLAS CHADWICK: "No. No single case did I find any measles virus in those children."

BRIAN DEER: "You looked at some cerebro-spinal fluid."

NICHOLAS CHADWICK: "That's right."

BRIAN DEER: "By lumbar puncture. Did you find any measles virus in those?"

NICHOLAS CHADWICK: "No."

BRIAN DEER: "So you found no measles virus in the children who were presented to the public at the very foundation of the MMR scare, where Dr Wakefield's theory was that it was measles virus itself that was responsible for a bowel disease, and then leading on to some kinds of autism, and you found no measles virus."

NICHOLAS CHADWICK: "That's correct."

Andrew Wakefield's response

Wakefield left his employment at the medical school in late 2001, and today continues to live off of the scare he created: running a Texas-based colonoscopy business called Thoughtful House, - employing, among others, endoscopist Arthur Krigsman and assistant Carol Stott. He spends much of his time travelling the United States, enjoying a luxury lifestyle and drawing new customers to his business by alleging an epidemic of autism and campaigning against the vaccine.

From the outset of Brian Deer's inquiries, Wakefield refused to co-operate, declining through his publicist Abel Hadden multiple requests for interviews. He ignored, or rejected through lawyers, written invitations to address the matters to be raised in the television documentary. And when approached by Deer and a film crew at an autism conference in Indianapolis, in October 2004, Wakefield attacked the camera and fled.

Nevertheless, either directly or through lawyers, Wakefield has denied misconduct, and claimed to have acted properly at all times. His wife, Carmel O'Donovan, has given supportive interviews to newspapers involved in backing his campaign, while litigant-parents and anti-MMR campaigners working with him have issued press notices denying that he was ever paid by Barr for research. In April 2004, Wakefield, with others, claimed that he had properly declared his legal funding in a 1998 letter to the Lancet: a claim rejected by the Lancet. Statements by Wakefield, and other material concerning him, can be found through an index page at this website.

In response to Brian Deer's first Sunday Times reports, Wakefield claimed in formal statements that the legal contract and payments were for a scientific study "quite separate" to the research published in the Lancet, although no such study was ever produced. In response to the Dispatches programme, Wakefield, again in a formal statement, denied that he ever planned a vaccine, which he said was only included in patent applications as "an afterthought". But following these claims - taken up worldwide by his supporters in attacks on Deer's integrity - fresh documents came to light on both the contract and the vaccine.

In December 2005, Wakefield's lawyers said in a letter that, contrary to popular opinion, he was not the cause of the MMR scare, but that “his hypothesis of a possible link between MMR and autism was but one episode in a much longer public health debate about vaccine safety.” His participation in this debate, they said, was “conscientious, reasonable and responsible for a research doctor in his position”.

The letter said that his work on MMR, and his connections with the lawyers Dawbarns and the Legal Aid Board [now the Legal Services Commission], were “well known both in the general media and amongst his colleagues from an early stage”.

In an "open letter" by Wakefield and others, published in June 2006 by a tiny rightwing US fringe group called the Association of American Physicians and Surgeons, he claimed that:

"Every aspect of the original 1998 report of the first 12 children with this disorder has been endorsed by independent research."

One of the signatories to this letter was a London GP, Richard Halvorsen. He was also hired by Barr, and was one of a small number of undistinguished doctors who cashed-in on the alarm Wakefield created. Halvorsen - now running his business out of Harley Street - sold parents single vaccines, of no established worth over the free MMR, with prices given by his business in 2007 as £335 for a course of three shots, without any consultation. In December 2004, another such GP, David Pugh, was jailed for forging test results suggesting that children were protected.

Particularly through his campaigning in the United States, Wakefield has also won new supporters, including, for example, one epidemiologist who in November 2007 wrote of the Lancet research:

"The paper is actually excellent - a superb case study that will join the ranks of other famous case studies, such as the link between rubella infection and congenital rubella syndrome (Gregg 1941) and between exposure to thalidomide and embryopathy (McBride 1956)... The paper, once understood in this light, as case series analysis, is truly remarkable, well written and brilliantly documented."

In statements issued in February 2004, Walker-Smith and Murch also denied misconduct: a stance they have subsequently restated.

Andrew Wakefield v Channel 4, Twenty Twenty Productions & Brian Deer

Brian Deer wasn't the first to try to get to the bottom of Wakefield's extraordinary activities. But, as doctors, including those at the UK's department of health, challenged him to substantiate his allegations, he threatened his critics with complaints. In March 2002, for instance, he formally complained to the GMC, alleging serious professional misconduct, over a senior Royal Free consultant who in December 1997 had told a paediatrician:

"There is a zealot surgeon in our adult gastroenterology department who thinks that MMR is the cause of all the problems of the Western world".

Wakefield even threatened to report the government's chief medical officer, Sir Liam Donaldson, to the GMC for having sought from the hospital, in February 2002, a file of ethics committee papers [that Brian Deer eventually obtained]. Wakefield wrote:

"It has come to my attention that you have sought details of our studies from the ethical practices committee of the Royal Free NHS trust. I infer from this that faced with an increasingly compelling scientific case against the MMR vaccine you are seeking to discredit the scientists involved. Your attempts to interfere in the scientific process are unacceptable. Not only do you have no right whatsoever to this information without permission, but also your action has had an indirect but nonetheless profound effect upon our ability to help these desperately ill children. I am seeking advice prior to taking this issue up with the General Medical Council."

These kind of harrying attacks weren't only aimed at doctors. Wakefield also mounted onslaughts against journalists. Brian Deer, of course, was repeatedly targeted, beginning with a typically-worded threat. "If you decide to publish, in spite of our conversations and all of the written material I have let you have over the last two days," Wakefield blustered to the legal manager of Times Newspapers Ltd, on 14 February 2004, "you will leave me no recourse other than to pursue you through the courts, in order to protect my reputation."

The most striking early incident, however, was a purported grievance lodged with the [former] Broadcasting Standards Commission over an ITV-1 "Big Story" programme, titled "A difficult decision". This was transmitted on 3 October 1996 - more than a year before the Lancet paper - and offered balanced coverage of Wakefield's claims at that time that vaccines against measles caused Crohn's disease. However, not only was Wakefield's complaint rejected by the commission [which described the programme as "a responsible investigation into a matter of considerable public interest"], but only six months after a hearing which adjudicated on the matter, Wakefield admitted at a private meeting that his own data on Crohn's disease suggested that it wasn't caused by measles at all.

Wakefield also revealed a penchant for threatening to sue others who challenged his conduct. Following Brian Deer's first Sunday Times reports - and before the extraordinary sums Wakefield pocketed from the MMR scare were unearthed - Wakefield instructed libel lawyers Peter Carter Ruck & Partners [on a contingency fee arrangement] to threaten both The Sunday Times and the Lancet, falsely suggesting that he'd properly disclosed his relationship with Barr's lawsuit. Both publications, however, rejected his complaint, and Carter-Ruck wasn't heard from again.

Later, in June 2005, Wakefield's then-solicitor, Simon Dinnick of the Medical Protection Society's lawyers Radcliffes LeBrasseur, was instructed to threaten the Cambridge Evening News, an English regional newspaper, which had reported on an aspect of the dispute. Among other things, Dinnick said that the newspaper's report alleged that the purpose of the research money from Barr "was to establish a positive link" between MMR and autism "thus suggesting a predetermined outcome and a lack of objectivity". Demanding an apology and a payment [which he successfully extracted from the poorly-advised little newspaper], Dinnick concluded on his client's behalf:

"There could hardly be a more serious allegation against a research gastroenterologist."

Ironically, the paper was too timid: Barr had hired Wakefield for precisely this purpose. But in this threat - and others circulated at the time - Wakefield blustered that he was suing for libel The Sunday Times, Channel 4 and Brian Deer, publisher of this website. He even went as far as having claim forms issued at the High Court office in London. But this, he'd later realize, was a big mistake, that some observers think sealed his fate. Channel 4 - Britain's independent public service network - had the resources to defend itself, and was determined to stand up to his threats. Within weeks, Wakefield's lawyers were trying to freeze the action, pleading for "protection from the Court" in the face of the mounting costs of his ploy. But, despite fielding a QC, Desmond Browne, and a full supporting team, Wakefield lost at every hearing. And in December 2005, he was ordered by a senior judge, Mr Justice Eady, to serve the necessary papers on the defendants: to "put up or shut up," as Channel 4's leading counsel, Adrienne Page QC, [supported by Matthew Nicklin] expressed it.

Endorsing Channel 4's position, the judge handed down comments on Wakefield's behaviour that must surely have proved unwelcome. Bluntly accusing him of using legal moves "as a weapon in his attempts to close down discussion and debate over an important public issue," Eady said, in the first of three judgments on the case - [1] [2] [3] - that he was satisfied "that the claimant wished to extract whatever advantage he could from the existence of the proceedings while not wishing to progress them or to give the defendants an opportunity of meeting the claims."

Many documents were exchanged during this heavy litigation, as is required by the UK's civil procedure rules. But the defendants were surprised by Wakefield's paltry disclosures, which were backed by signed statements of truth. If these statements were correct, then Wakefield - architect, with Barr, of a worldwide crisis over the safety of a children's vaccine - possessed almost no data to support his allegations, and had destroyed vital records of purported findings. Despite the earlier claim by Wakefield that the legal money went into a "quite separate" study to that published in the Lancet, moreover, no such study was ever produced, despite two years of litigation. Indeed, the relevant materials Wakefield appeared to have accumulated during his campaign were, by reference to his legal submissions, less extensive than Brian Deer's journalism. So striking were the omissions - particularly regarding alleged virological studies - that the defendants were prepared to apply to the court, challenging Wakefield's statements of truth.

What Brian Deer's Dispatches programme had said was agreed by both sides in the libel litigation to have been very serious indeed. They went to "the heart" of Wakefield's "honesty and professional integrity", as Eady put it in the first of his judgments. Among the many serious charges the defendants admitted Deer's investigation levelled against Wakefield - and which one must assume he denies - was that he:

"knew or ought to have known that there was absolutely no scientific basis at all for his belief that MMR should be broken up into single vaccines."

And that he:

"acted dishonestly and irresponsibly, by repeatedly failing to disclose conflicts of interest and/or material information, including his association with contemplated litigation against the manufacturers of MMR and his application for a patent for a vaccine."

And that he:

"caused medical colleagues serious unease by carrying out research tests on vulnerable children outside the terms or in breach of the permission given by an ethics committee, in particular by subjecting those children to highly invasive and sometimes distressing clinical procedures and thereby abusing them."

Indeed, Channel 4 and its co-defendants went further, confirming in court papers that they accused the former surgeon of having been:

"unremittingly evasive and dishonest in an effort to cover up his wrong-doing."

On 2 January 2007, however, following court orders compelling Wakefield to turn over to the defendants a mass of undisclosed documents [including medical records for the Lancet children] - and just two days after the £435,000 he pocketed from his attack on MMR was exposed in The Sunday Times - he abruptly abandoned his libel claim, and agreed to pay the broadcaster's costs, estimated at about £500,000 [$1,000,000].

Three weeks later, he abandoned a second, near-identical, action against this website, and a third, against Times Newspapers Ltd. He would argue, through his lawyers, that this was to allow him to concentrate on preparing for the hearing of the General Medical Council, to begin in July 2007, at which he faced charges of serious professional misconduct. But there was considerable overlap between the issues, and Sunday Times lawsuit, for example, had already been stayed by the court, and was inactive until after that hearing.

Finally, in what must have felt like a humiliating climbdown, in February 2007, Wakefield, through Radcliffes LeBrasseur, paid compensation to Brian Deer for the costs of defending this website.

General Medical Council hearing

Following Brian Deer's first Sunday Times reports, the Lancet said that it regretted publishing the paper, which, after defending, and even glorifying, Wakefield's work for six years, it admitted in February 2004 to be "fatally flawed". The editor, Richard Horton, told the BBC:

"In my view, if we had known the conflict of interest Dr Wakefield had in this work I think that would have strongly affected the peer reviewers about the credibility of this work and in my judgement it would have been rejected."

As uproar greeted Deer's revelations, Tony Blair, the prime minister, called for renewed support for the vaccine. And the following month, by a majority of 10 to 3, the Lancet paper's authors, including Walker-Smith and Murch, further vindicated the public interest in Deer's investigation, by retracting the finding of a possible MMR-autism link, set out in the paper's "interpretation" section. They wrote to the Lancet, in a statement published on 6 March 2004 [pdf of retraction]:

"We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent."

Shortly before this retraction [for the retracted "interpretation" text, check the opening abstract of the Lancet paper], the General Medical Council announced its own investigation into the affair, which it said raised questions over Wakefield's fitness to practice medicine. GMC officials then approached Brian Deer and asked if, in the public interest, he would pass them his findings, and later requested him to supply his research materials - including pivotal documents - to the council's retained lawyers, at the firm of Field Fisher Waterhouse [FFW] in London. Deer, however, is not the complainant in the case - which was brought on the GMC's own initiative - and his information has been compounded with submissions, including complaints, from dozens of other sources, including parents directly involved.

Before the GMC announced its disciplinary inquiry, Wakefield declared that he supported such a development. “It has been proposed that my role in this matter be investigated by the General Medical Council,” he said in a statement. “I not only welcome this, I insist on it, and I will be making contact with the GMC personally, in the forthcoming week." But despite his insistence, he offered the UK medical profession's regulatory body little cooperation: a stance he retained for the next three years as FFW acceded to his public demand, and collected statements and documents from doctors, parents, scientists and other sources, sometimes relying on the GMC's statutory powers laid down in the 1983 medical act.

In December 2006, following an examination of only some aspects of Wakefield's conduct [excluding, in particular, his activities with regard to Crohn's disease and his alleged identification of measles virus, which were matters judged to be disproportionately time-consuming to prove to the required standard], a raft of charges were laid against him. These embrace allegations of research and financial misconduct; exploiting autistic children with high-risk medical procedures without clinical necessity, ethical approval or contractual permissions; buying blood from children at a birthday party; misleading a panel of the Medical Research Council; and failing to disclose financial and commercial conflicts of interest, notably his contract with Barr and his patent for a single vaccine.

Despite false stories, placed by Wakefield's by-now dramatically shrunken band of supporters, suggesting that the GMC was uncertain over whether the case would proceed, the scheduled disciplinary hearing began in London on 16 July 2007, before a two-lay and three-medical member panel, chaired by Dr Surendra Kumar, a general practitioner and president of the British International Doctors Association. Other panelists are Sylvia Dean, a member of the Employment Tribunal, Wendy Golding, chair of the London borough of Southwark Housing Tribunal, Dr Parimala Moodley, a member of the council of the Royal College of Psychiatrists, and Dr Stephen Webster, a retired consultant geriatrician.

As the hearing has progressed, the panel has been presented with an unprecedented analysis, not only of what Wakefield, Walker-Smith and Murch did at the Royal Free between 1996 and 1998, but also the extraordinary manner of the children's treatment. Although full details of the proceedings will be withheld until after their expected completion in April 2009, the prosecution case amounts to allegations that uniquely vulnerable, developmentally disordered children - most of whom, the GMC says, had no reason to be brought to London and admitted to the hospital's paediatric bowel unit at all - were systematically exploited in a speculative and unethical fishing expedition, masterminded by Wakefield. Pursuant to his theories over Crohn's disease, this venture was intended to find measles virus in their guts and spines, and other symptoms or signs which could be invoked in Barr's litigation.

Although, amazingly, Wakefield had never [and has never] had legal care of a patient at any time in his career - and his Royal Free contract explicitly prohibited any clinical responsibilities - it was heard in evidence that he would telephone parents at their homes and, speaking with the apparent authority of a hospital consultant, lead them to think that their children - who he'd never seen - may suffer from a serious inflammatory bowel disease. Understandably, these parents were wracked with worry by these calls, and became anxious for their children to undergo Wakefield's investigations. One mother's GP was even advised that one of her sons might have a fatal degenerative brain disease, on the grounds that the boy had headaches.

"Parents may be so overcome by the nature of their child's disorder that it's difficult for them to retain some objectivity," Professor Ian Booth, a consultant paediatric gastroenterologist and dean of the Birmingham university medical school, said in evidence for the GMC. "They had clearly not been able to satisfy themselves about the cause of their child's symptoms previously. And they'd, I think, been put in a very vulnerable position."

Also giving evidence for the GMC, the mother of one child enrolled in Wakefield's Lancet project told the hearing that she had first been persuaded of a possible link between the vaccine and autism "in hindsight" by another of the parents. She had then contacted Wakefield directly, and at the same time - again on the parent's advice - registered as a client of Barr's. "It was like a jigsaw puzzle that seemed to fit into place," she explained, adding that she understood Wakefield's activities to have been "a research programme" and that Barr was "trying to really put a stop to the MMR vaccine being used".

Curiosities at the mammoth hearing have included Wakefield's decision during the first session to put no questions to Dr David Salisbury, a GMC witness from the government's department of health, and at the second session - in April 2008 - to produce no witnesses to corroborate his own account. But, during five weeks of examination and cross-examination, he rejected all of the GMC's charges. Among other points, he denied dishonesty, and said that all of his work was executed in good faith. He said that children admitted for the research published in the Lancet were seen purely by clinical need, and claimed that the "pilot study" he carried out for Barr was begun after the Lancet research was completed. He presented evidence that he said suggested that the editor of the Lancet should have been aware of a connection with Barr before the journal published the paper. He also said that others at both the Royal Free hospital and medical school were aware of his relationship with the lawyer. With regard to an allegation that he had bought blood from children at a birthday party, Wakefield said that his videotaped recollection of this event, in which he publicly joked about the children crying, fainting and vomiting, was largely made-up, for which he expressed regret.

Wakefield said that he'd failed to notify the ethics committee of his contract with Barr because he'd filled-in his application to the committee before the legal money was authorised, signed the document afterwards, but failed to re-read it and make the necessary amendment. He denied that he had any further responsibility in this respect, or that he'd a "duty to ensure" that the committee was given accurate information. Asked about the conflict of interest between his employment by Barr and his publicly-adopted role as an apparent independent researcher, Wakefield said: "I didn't realize that it would cause the concern it did, because I didn't understand the basis of the concerns."

Under cross-examination, Wakefield praised the lawyer who, two years before the Lancet paper was published - we now know - had hired him to attack the vaccine. "What struck me when I met Richard Barr and Kirsten Limb was that they had a deep knowledge of the subject, and they were motivated very much by their genuine concern for the children," he said. "They were not in any shape, manner or form ambulance chasers."

Second to give defence evidence was Prof John Walker-Smith, who in almost five weeks of testimony in July and August 2008 also denied misconduct. He argued that he only saw children by clinical need, and he defended all tests and investigations as having been performed on clinical, not research, grounds. He said he didn't know that Wakefield's employment contract forbade clinical involvement, and that he didn't know about either Wakefield's private company Immunospecifics Ltd or Wakefield's measles vaccine patent. He also denied knowing that parents were litigants: either when they came to the hospital or when the Lancet paper was published. Shown documents in which litigation matters were raised with him at the time - such as a letter from Wakefield telling him that Legal Aid Board money was available to pay for a child's admission to the hospital - he said he didn't then recognise the significance. "I had no real knowledge of what the Legal Aid Board was," he told the hearing. "I did have some anecdotal knowledge of lawyers being involved with particular children, but no more than that."

Walker-Smith was asked by his counsel, Stephen Miller QC, when he was first aware of the sums of money involved. "I had a late evening telephone call from the investigative journalist Brian Deer at my home - a rather disturbing telephone call," he replied, referring to a conversation in December 2003. "And in the course of that telephone call I think he mentioned the sum of £55,000 being allocated to Andy Wakefield. I was quite unaware of that, and I was quite shocked to hear that."

He said the Lancet paper provided no evidence that MMR caused autism, and blamed the Royal Free's press conference and what he called "the media" for leading people to think it did. All of his grandchildren had been vaccinated with the triple shot, he said. Notwithstanding the formal statements by himself and his co-defendants in 2004 to the contrary, he now denied that the 12 children reported in the paper were investigated under the ethics committee application, and claimed that the research project for which approval was sought in 1996 was never carried out. He denied that he'd a "duty to ensure" that the paper was "true and accurate", and said that he had "trusted" Wakefield to ensure that it was correct. He told the hearing: "I don't know what the term 'senior author' means", and with regard to the statement in the Lancet saying that investigations had been approved by the Royal Free's ethics committee, he said that he had no "input" to that statement. Questioned by Miller, he confirmed his support for the retraction of March 2004, which he said was brought about by the "new information" which had come to light.

Walker-Smith's evidence, as Wakefield's had done before him, provoked a number of sharp exchanges. "I'm afraid I have to suggest to you that you are making it up as you go along," said Sally Smith QC, cross-examining for the GMC, on 5 August, with regard to the retired professor's account of the ethical issues.

He replied: "That is completely untrue, Ms Smith."

Although the GMC's lawyers sourced or re-sourced their evidence independently of Brian Deer's investigations, much of the hearing has followed the same lines as material published at this website. Due to protections afforded uniquely to doctors, however, the hearing has proved tough - and expensive - going. Although the rules have recently changed, not only is this GMC case required to be proven to the standard of criminal trials, rather than to the civil standard in disciplinary hearings in all other occupations [including the police], but, under the governing 1983 medical act, the GMC has no powers to compel those facing charges to volunteer information, or even to supply a statement of their case. This contrasts with civil court hearings [as Wakefield's disastrous libel adventure demonstrated] where parties are ordered to save time and money by sharing information and by narrowing the areas of dispute. And while, in tackling crime, the police might kick down a suspect's front door, seize their records and warn them that it may harm their defence if they fail to mention something which they later rely on in court, in GMC cases the accused can stand mute behind a wall of non-cooperation: vastly increasing the mountain of effort the prosecution is forced to scale. Thus, the doctors have been able to drag the case out: withholding their evidence - including documents and responses - for years after the GMC's approach.

While the defendants have thus been able to increase the costs and time involved, there have also been issues of legal privilege and medical confidentiality, which have been erected around Wakefield's activities for Barr. The lawyer himself has declined to appear before the GMC panel, and meanwhile, a handful of former litigants and crank hangers-on are running a campaign of hatred and abuse that, critics say, aims to conceal their own role in the MMR debacle by denigrating those who've told the truth. This has even included fabricating smears, insinuating that Brian Deer - whose journalism also nailed plagiarist Dr Raj Persaud [PA News, BBC radio] before the GMC in June 2008 - is working with the drug industry. And it has seen them launch a website causing more unwarranted distress to parents by publishing a substantially false account of the proceedings. This account is expected to be compiled into a self-published book, skimming profit from those it misleads. The intended author has a history of latching onto vulnerable people, and was heard bragging outside a GMC session that he could pocket 80% on sales of such books.

So unsavoury is this character that, on 3 November 2008, even Wakefield, Walker-Smith and Murch joined with the GMC in condemning an attempt by him to smear the panel's chairman, Dr Kumar, with false allegations of a conflict of interest through an alleged shareholding in a drug firm. Counsel for the defendants unanimously agreed that there was no such conflict. "Unfortunately this is not a court of law and does not have the benefit of contempt jurisdiction, otherwise I might be giving a lot further advice to the panel," Nigel Seed QC, the hearing's independent legal assessor, said. "If anybody was misguided enough to think they were helping any of the parties, they were not."

The story goes on...

In late 2008, measles is on the rise, and more parents than ever are being misled into blaming themselves for autism. But evidence suggests that the tide is turning over Wakefield, and that, as the truth about the basis of the campaign against MMR surfaces, even deeply-involved parents and anti-vaccine campaigners are considering "a life after Andy". Although, before Brian Deer's first reports, Wakefield had stated that his reputation was already such that he would never work again in Britain, lawyers running emerging litigation over MMR and other vaccines in the United States have dropped him from lucrative expert witness panels, and his papers have been excluded from lists of scientific research upon which the American claimants say they will rely.

Meanwhile, in September 2008, a uniquely-authoritative virological study, co-authored by O'Leary - whose lab had evidently been brought up to a better standard since facing earlier criticisms - repudiated Wakefield's core claims. The study paper concluded:

"The work reported here eliminates the remaining support for the hypothesis that ASD with GI complaints is related to MMR exposure."

This study was ethically reviewed by four institutional bodies, and only drew on data from children who, unlike Wakefield's subjects, were admitted to hospital for ileocolonoscopies which were purely for clinical reasons, unrelated to research. One collaborator in the project - who also now publicly repudiated Wakefield's claims - was Dr Timothy Buie, of Harvard university: America's leading paediatric gastroenterologist with a special interest in autism.

As pennies have dropped, views have begun to change, with some parents even writing to tell Brian Deer that they supported his investigation: which followed 20 years of similar Sunday Times public interest probes, including inquiries into contraceptive pills from the Schering AG and Wyeth drug companies, antibiotics from Wellcome and Roche, sex drugs from Pfizer, and painkillers from Merck.

With regard to the events at the Royal Free, one mother wrote in an email:

"You'll never get a thank you for stopping the bad things happening to the kids because sadly they aren't capable of saying it, which is the reason they became victims in the first place."

Meanwhile, a father from one of the many families only now recovering from the strain of Barr's futile litigation wrote:

"Personally I think 'shot by our own side' just about sums it up. I still find it shocking what Wakefield did, and we never blame you for exposing it."





Richard Barr:
UK lawyer who, from 1992, spent 12 years and £15m of public money trying to find fault with the vaccine. Before giving up in 2004, he said he'd always sought to represent what his clients told him.


Jackie Fletcher:
The mother of a brain-disordered boy used until 1996 as the model of alleged MMR damage. Runs a UK campaign group, JABS, and was the main public face of the attack on the vaccine. Barr client.


Kirsten Limb:
After consulting Barr on another matter, she became his firm's researcher, spending hundreds of hours pulling scraps from medical journals to supply to Wakefield (right) and Barr, who she later married.

Rosemary Kessick:
In 1996, her autistic son was substituted for Fletcher's child as the model of MMR damage. Principal litigant in vaccine lawsuit. Supplied Wakefield with parts of his autism theory. Also a Barr client.

Andrew Wakefield:
An ex-surgeon, embittered after his theory that measles virus caused Crohn's disease was scorned. Published a string of false and misleading reports, seeking to discredit MMR. Financed via Barr.

How they shattered parents' confidence. MMR vaccination rates for England and Wales, by second birthday in year: | 91-92 = 90% | 92-93 = 92% | 93-94 = 91% | 94-95 = 91% | 95-96 = 92% | 96-7 = 92% | 97-8 = 91% | 98-9 = 88% | 99-00 = 88% | 00-01 = 87% | 01-02 = 84% | 02-03 = 82% | 03-04 = 80% | 04-05 = 81% | 05-06 = 84% | 06-07 = 85% | 07-08 = 85% | Source: Health Protection Agency. See graphs. See another graph.






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