Andrew Wakefield

<youtube size="tiny" caption="‪Wakefield defends his autism vaccine research‬ on CNN, January 2011" align="right">8QHGKPNMtUQ</youtube> Dr Andrew Jeremy Wakefield (born 1957) is former British medical researcher and surgeon who suggested in 1998 that the measles, mumps and rubella (MMR) combined vaccine might be linked to inflammatory bowel disorders and play a role in an increased risk of autism. As the lead author of a peer-reviewed paper published in the respected medical journal The Lancet, his controversial claims sparked high-profile media coverage over the next decade, including campaigns by the Daily Mail, Telegraph and Private Eye questioning the safety of the UK government’s chosen vaccine. Public confidence in the MMR jab plummeted, resulting in a sharp fall in uptake and a reported rise in measles cases among children.

Allegations of ethical misconduct against Wakefield and two former colleagues involved in the Lancet study prompted the British General Medical Council (GMC) to begin in 2007 what became its longest ever ‘fitness to practise’ investigation. In January 2010 a GMC tribunal ruled that Wakefield and Professor John Walker-Smith were guilty of serious professional misconduct. As a result, The Lancet retracted the original paper, 12 years after it was first published. Both doctors were struck off the medical register in May 2010, and have since filed High Court appeals.

In January 2011 the editors of the British Medical Journal took the rare step of declaring Wakefield’s study “an elaborate fraud” and published a series of lengthy articles by investigative journalist Brian Deer, who had covered the case for over seven years. These detailed alleged falsification of data and conflicts of interest. The BMJ also called for the veracity of Wakefield’s previous research papers to be examined.

Wakefield, who now lives in the USA, continues to stand by his research and deny all allegations against him, including the GMC’s findings. His supporters, mostly parents of autistic children, maintain he is the victim of a conspiracy and witch-hunt. In recent TV interviews responding to the BMJ’s articles, Wakefield said he would publish documents that would disprove the allegations and called upon people “to read the truth in my book”. He said: “There was no fraud, there was no falsification, there was no hoax."

Background

Wakefield is from a medical family; his parents were a GP and neurologist. He qualified as a doctor in 1981 at St Mary’s Hospital Medical School, London, before spending his early professional career in Canada. In 1985 he became a fellow of the Royal College of Surgeons. After some years as a transplant surgeon he returned to the UK in the late 1980s. He began working at the Royal Free Medical School in the early 1990s as a senior lecturer in the Departments of Medicine and Histopathology. In May 1997 he was appointed a Reader in Experimental Gastroenterology. He was also an Honorary Consultant in Experimental Gastroenterology with a stipulation in his contract that he had no involvement in the clinical management of patients.

The controversial Lancet paper

Wakefield was lead author with eleven other researchers of the peer-reviewed paper published in February 1998 in the Lancet. This consisted of a case review of 12 children sequentially referred to the gastroenterology unit of London's Royal Free Hospital, where Wakefield was a reader in experimental gastroenterology. According to the paper, these children had "a history of normal development followed by loss of acquired skills, including language, together with diarrhoea and abdominal pain."

The paper said: "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." While the paper noted some parents' views that those environmental triggers included the MMR vaccine, the paper itself did not claim a causal link.

Wakefield commented to the media (i.e. not in the paper itself) that the children's behaviour changed drastically shortly after they received the MMR jab. He said: "This [Autistic enterocolitis] is a genuinely new syndrome and urgent further research is needed to determine whether MMR may give rise to this complication in a small number of people." He theorised that the combination of the three virus strains contained in MMR may overload the body's immune system and cause the bowel disorder to develop.

At a press conference, Wakefield said he believed that instead of the triple MMR, children should be given doses in single jabs, preferably a year apart. The ensuing public furore 'directly' resulted in a dramatic fall in public uptake of the MMR vaccine down as low as 80 % in 2003-04. The BMJ points out that subsequent epidemiological studies “have consistently found no evidence of a link between autism and the vaccine”.

In October 2001 Wakefield was asked to leave the Royal Free after failing to mount a large-scale controlled study to confirm or refute his claims about MMR.

In 2004 Lancet editor Richard Horton publicly rejected the paper after it emerged that Wakefield had failed to declare he had received £55,000 in legal aid funds to advise solicitors representing parents considering suing over MMR. Soon after, ten of Wakefield’s co-authors and ex-colleagues also published a statement formally retracting the paper’s interpretation of the possible link between the MMR vaccine and autism, in view of the fact that ‘consequent events have had major implications for public health.’ Wakefield and two co-authors responded on both issues, stating Wakefield had never concealed the legal aid funding, and had never made the claim of a causal link nor interpreted a possible MMR/autism link, so it was “difficult to know quite what has been retracted”.

The BMJ: an ‘Elaborate Fraud’

BMJ cover January 2011

The BMJ editorial in January 2011 by editors Fiona Godlee, Jane Smith and Harvey Marcovitch stated they had “no doubt” that Wakefield “had perpetrated… fraud” in his flawed 1998 paper. Investigations by journalist Brian Deer, they said, had uncovered “clear evidence of falsification” of patients’ medical histories by Wakefield “in order to support his claim to have identified a new syndrome”. They stated that:

not one of the 12 cases reported in the 1998 Lancet paper was free of misrepresentation or undisclosed alteration, and … in no single case could the medical records be fully reconciled with the descriptions, diagnoses or histories published in the journal.

Furthermore:

a great deal of thought and effect must have gone into drafting the paper to achieve the results he wanted: the discrepancies all led in one direction: misreporting was gross.”

Wakefield responded to the BMJ in a raft of TV interviews in the USA. He claimed Brian Deer had got it wrong.

when you analyse the records, as I have done meticulously .. what he has done is manipulated and falsified the way in which he compared the original GP's records … with what we wrote. What we wrote in the Lancet is a precise replication of what the parents told us. And … when you go back and check it with the original [GP] records … which I have to say ... were not available to us at the time.

The BMJ editors said hard lessons had emerged from this “highly damaging saga”, particularly for the co-authors who the GMC had found were seemingly unaware of which child was which in the study’s anonymised text and tables; it was Wakefield alone who wrote the final version of the paper. In a subsequent editorial, editor-in-chief Fiona Godlee declared that a review of documents on the Lancet’s supposed ‘full investigation’, obtained under the Freedom of Information Act, made it “hard to escape the conclusion that this represents institutional and editorial misconduct”.

GMC fitness to practise hearing

In January 2010, the GMC announced the results of a two-and-a-half year investigation by a five-member panel into the fitness to practise of Wakefield and two other doctors from the MMR research team, Professor Simon Murch and Professor John Walker-Smith. Wakefield and Walker-Smith were found guilty of professional misconduct and were struck off the medical register. Murch was found not guilty.

The disciplinary panel also found Wakefield guilty of dishonesty concerning the study’s admissions criteria, its funding by the Legal Aid Board and his statements about it afterwards.

On 2 February 2010, The Lancet retracted Wakefield and his co-authors' paper. Editor Richard Horton told the press: "It was utterly clear, without any ambiguity at all, that the statements in the paper were utterly false." The Lancet’s press statement did not comment on the paper’s findings but focused on how the children were referred to researchers and whether ethics committee approval had been obtained at the time of publication:

Following the judgment of the UK General Medical Council’s Fitness to Practise Panel on Jan 28, 2010, it has become clear that several elements of the 1998 paper by Wakefield et al are incorrect, contrary to the findings of an earlier investigation. In particular, the claims in the original paper that children were ‘consecutively referred’ and that investigations were ‘approved’ by the local ethics committee have been proven to be false. Therefore we fully retract this paper from the published record."

The GMC report on the hearing (GMC, Fitness to Practise Panel Hearing, 28 January 2010) can be read here. The Panel made it clear this case was "not concerned with whether there is or might be any link between the MMR vaccination and autism"but rather “concerned itself exclusively with the conduct, duties and responsibilities of each doctor at the material times”.

The report outlines 30 charges against Wakefield, including four counts of dishonesty and 12 of causing children to be subjected to invasive procedures that were clinically unjustified. The panel found Wakefield had not obtained proper ethics committee approval for the tests he allowed to be performed on children, and rejected the proposition that no specific approval was required.

Some other detailed points that emerged:

• Serious symptoms of bowel dysfunction and autism were suffered by children that featured in Wakefield et al's case review, and these were linked by parents and in some cases by GPs and consultants (ie not just Wakefield and the other two doctors on trial) to the MMR vaccine
• A whole team of doctors and consultants - not just Wakefield and the other two doctors on trial - were caring for and deciding on the investigations to be performed on the children and on their treatment. These experts are all named in the report.
• The invasive procedures (colonosocopy and lumbar punctures) that Wakefield was accused of causing to be done on the children were standard investigations performed at the hospital on children suffering serious bowel symptoms and/or suspected meningitis. It also becomes clear that Wakefield was not in charge of deciding on or carrying out these procedures, which were done by consultants whose speciality they were. However, the GMC panel decided that in the case of a lumbar puncture on a child, "by signing the forms you [Wakefield] ordered the investigations".

While all the allegations against the doctors are published fully in the report, with the GMC panel's verdict on each allegation (e.g. "proven" or "not proven"), the doctors' defences do not appear, other than in the brief phrase ‘admitted’. As of June 2010, the main coverage of the doctor's defences is by health writer Martin Walker, who regularly attended the hearing and in the account of Jim Moody, attorney for the National Autism Association (NAA) in the US, who alleged "false and misleading testimony" was given against the doctors at the hearing. Moody submitted an official complaint to the GMC against some of those who testified against Wakefield and colleagues (Dr Richard Horton, Dr David Salisbury, Dr Arie Zuckerman, Dr Michael Pegg, and Dr Michael Rutter), for what Moody alleged was "Breach of duty of honesty and candor; False Testimony; Misuse of Professional Position, Failure to Disclose Conflicting Interest, False Expert Testimony".

Conflicts of interest: GMC

• Professor Denis McDevitt, who was originally proposed by the GMC as chair of its fitness to practice investigation into Wakefield and colleagues, was himself a member of a 1988 government safety panel which approved Pluserix MMR vaccine as safe for vaccine manufacturer Smith Kline & French Laboratories (later GlaxoSmithKline). This was revealed in previously secret government minutes that were disclosed by the MMR litigation brought by parents of alleged MMR-damaged children. Also, at the time that the panel approved the vaccine, McDevitt was being paid as a research fellow by MMR vaccine manufacturer, Smith Kline & French Laboratories.

The government minutes that reveal these facts are also interesting from the point of view of the adverse reactions reported to the early version of the MMR vaccine, using the subsequently discontinued Urabe strain of mumps virus. The reactions included convulsions, neurological complications, meningitis, and encephalitis. One member of the panel raised concerns about "the potential infectivity of the mumps component of MMR to susceptible contacts", though he was "assured" that it was "not transmissible".

According to an article by Martin Walker on the Age of Autism vaccine damage information site, McDevitt was dropped as proposed chair of the GMC fitness to practice hearing into the three doctors when campaigners revealed these conflicts of interest. The chair subsequently chosen by the GMC was Dr Surendra Kumar.

• Dr Surendra Kumar chaired the GMC fitness to practice hearing into the three Royal Free doctors. He read out the verdict of the General Medical Council (GMC) panel, which condemned the doctors as “dishonest”, “irresponsible”, and as acting “contrary to the clinical interests of this child”. In 2003 Kumar disclosed a shareholding in GlaxoSmithKline. He still had shares in GSK in 2004. GSK was a defendant in litigation brought by parents of alleged MMR-damaged children under the legal aid scheme, litigation in which the parents employed Wakefield as an expert witness.

Conflicts of interest: Andrew Wakefield

Legal aid work for parents suing vaccine manufacturers

Dr Andrew Wakefield was first publicly accused in 2004 of a conflict of interest regarding his employment by the lawyers for the group of parents who sued vaccine manufacturers for alleged vaccine damage of their children. He had received £55,000 for this work, which was deposited in a special trust controlled by the Royal Free. Dr Richard Horton, then editor of The Lancet, told the GMC that he was unaware of this at the time he published the MMR paper, though Wakefield told the GMC he had declared it. A discussion of this incident by John Stone, a supporter of the vaccine-damage advocacy group JABS and parent of an autistic child, based on contributions to the BMJ Rapid Responses forum, can be read here.

One argument that Andrew Wakefield was legally correct in stating this was not a conflict of interest was made, ironically, by those making the case for MMR. In defending herself against a parallel allegation of conflict of interest made in Private Eye (19 March 2004), Professor Elizabeth Miller, head of the Health Protection Agency's Immunisation Department and expert witness for the vaccine producers - presumably with the best legal advice - wrote:

there can be no conflict of interest when acting as an expert for the courts, because the duty to the courts overrides any other obligation, including to the person from whom the expert receives the instruction or by whom they are paid.

Barrister Robert Hantusch also gave this legal view in a letter to the Times dated 24 February 2004:

But the courts do not consider that the engagement of someone to act as an expert witness in litigation has the effect that that person is then biased. Indeed, if this were the legal position, no paid professional could ever at any time give evidence to a court.

Documents obtained under the Freedom of Information Act and published by The Sunday Times in December 2006 revealed Wakefield had been paid over £435,643 in fees and £3910 in expenses from legal aid funds over an 8-10 year period. Five of his former colleagues at the Royal Free, received a total of £183,000 in fees, according to the Legal Services Commission. One of those who received the payments, Dr John Murch, acknowledged there “was a huge conflict of interest".

Patenting a rival vaccine

Wakefield was accused of another conflict of interest by Brian Deer in the Sunday Times and Channel 4 Television's 'Dispatches' for filing a UK patent in 1997 as a co-inventor of an alternative vaccine against MMR, and a pharmaceutical composition for treating inflammatory bowel disease.

Wakefield had instructed agents to file the patent, naming the applicants as the Royal Free Hospital and Neuroimmuno Therapeutics Research Foundation, a US-based organisation headed by immunologist Hugh Fudenberg, his proposed co-inventor.

Wakefield refuted Deer's and the Dispatches allegations on this issue in a written statement, which Deer published on his own website. This issue also formed one of the planks of libel proceedings against Deer and Channel 4, which Wakefield later dropped and was ordered to pay costs on.

The claim appears to be that, whilst at the Royal Free Hospital, I was developing a new vaccine to compete with MMR and that I conspired to undermine confidence in MMR vaccine in order to promote this new vaccine, and that this represented a conflict of interest. This is untrue. The facts are that:

• no vaccine or anything resembling a vaccine was ever designed, developed or tested by me or by any of my colleagues at the Royal Free Hospital;
• it has never been my aim or intention to design, produce or promote a vaccine to compete with MMR;
• my genuine concerns about the safety of MMR are wholly unrelated to any desire or opportunity to develop a competing vaccine;
• there was no conspiracy as insinuated by the Sunday Times article;
• there was no conflict or interest, actual or perceived.

In contrast, it was our intention, at one stage, to conduct a formal therapeutic clinical trial of a compound that might have the ability to promote the body’s immune response to measles in order to assess the effects of this therapy upon the disease in children with regressive autism and bowel disease. This compound is known as Transfer Factor and whilst there is a large scientific literature on this subject, the nature and mechanism of action of Transfer Factors are largely unknown.

The Transfer Factor that was intended for use in the trial was to be against measles virus. I have urged and continue to urge parents to have their children vaccinated against measles using the current vaccines. This would be in direct conflict with the intentions that are part of the claim that I was developing a new vaccine to bring onto the market. Whether a Transfer Factor could ever protect children against measles is entirely speculative and is something that was never studied or pursued by me or any of my colleagues.

The Channel 4 programme implies commercial aspirations for personal gain. In fact, the aim of the patent was to generate funding for the research programme and a new Centre for Gastroenterology at the Royal Free Hospital. This can be substantiated by contemporaneous documentation.

The patent application was motivated by two main factors. First, it was felt that there may be difficulty in raising traditional grant funding for cutting edge, controversial work that was vulnerable by virtue of the fact that it might conflict with perceived wisdom and the commercial interests of others. Secondly, there was, and is, a government-led emphasis on commercial exploitation of discoveries within the medical school.

In 2010, the GMC report stated as ‘admitted and proved’ that Wakefield had approached the Royal Free ethics committee around the same time he was involved in a proposal to set up a company called Immunospecifics Biotechnologies Ltd to specialise in the production, formulation and sale of Transfer Factor. The proposed MD of the company was the father of ‘Child 10’, with Wakefield as research director. The GMC panel found Wakefield had ‘inappropriately caused Child 10 to be administered Transfer Factor.

In 2011 articles by Brian Deer in the BMJ further outlined Wakefield’s complex business arrangements on this matter. See: Secrets of the MMR scare: How the vaccine crisis was meant to make money.

Resources

See also:

• Crispin Davis
• Nigel Davis
• MMR