Andrew Wakefield

Dr Andrew Wakefield was a researcher who suggested that the measles, mumps and rubella (MMR) combined vaccine might be linked to an increased risk of autism and bowel disorders. In 1998 Wakefield and eleven others published a peer reviewed paper in the Lancet which 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. The paper said the 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. This is consistent with the nature of epidemiological research, which does not identify cause-and-effect but only points to associations or correlations.

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 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."

Wakefield 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.

The publicity following the paper's publication resulted in a dramatic fall in public uptake of the MMR vaccine.

GMC hearing

In January 2010, the results of a three-year investigation by the General Medical Council into the fitness to practise of Wakefield and two other doctors from the MMR research team, Professor Simon Murch and Professor John Walker-Smith, were announced: Wakefield and Walker-Smith had been found guilty of professional misconduct and were struck off the doctors' list. Murch was found not guilty.

The Lancet, the journal that published Wakefield and colleagues' paper, retracted it on 2 February 2010.

The GMC report on the hearing (GMC, Fitness to Practise Panel Hearing, 28 January 2010) can be read here. The following factors emerge from the report:

• 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
• 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".

Wakefield was accused of not obtaining proper ethics committee approval for the tests he allowed to be performed on the children. But according to journalist Brian Deer, Wakefield said in 2005 that the Lancet study was a case review of patients referred to and treated at the Royal Free rather than a clinical research study and therefore no ethics committee approval was required: "In contrast to a clinical research study requiring ethical approval, the Early Report was a report of clinical findings of tests which had been performed solely on the basis of clinical need".

The Royal Free told the Lancet in 2004 that it saw "no ethical wrongdoing" in the study.

It is not possible for any member of the public to read both sides of the story in the GMC report. This is because while all the allegations against the doctors are published fully, with the GMC verdict on each allegation (e.g. "proven" or "not proven"), the doctors' defences do not appear. Nor have the doctors' defences been quoted in media coverage, reportedly because no media persons attended the hearing but only turned up for the verdict. As of June 2010, the only coverage of the doctor's defences is in the account of the health writer Martin Walker, who did attend the hearing and in the account of Jim Moody, attorney for the National Autism Association (NAA) in the US, who said that "false and misleading testimony" was given against the doctors at the hearing. Moody submitted an official complaint to the GMC against some who gave testimony (Richard Horton, Dr David Salisbury, Dr Arie Zuckerman, Dr Michael Pegg, and Dr Michael Rutter), for what he 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

Dr Andrew Wakefield was accused of a conflict of interest in that he was employed by the group of parents who sued vaccine manufacturers for alleged vaccine damage of their children. Dr Richard Horton, then editor of The Lancet, told the GMC that he had been unaware of this alleged conflict of interest on the part of Wakefield at the time he published Wakefield's MMR paper in The Lancet, 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, based on contributions to the BMJ Rapid Responses forum, is here.

The argument that Andrew Wakefield was legally correct in stating that there was no conflict of interest in this respect 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.

This legal view was also given by barrister Robert Hantusch in a letter to the Times of 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.

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

Deer's evidence for his allegation that Wakefield applied for a patent on a rival vaccine is here:

Revealed: the first Wakefield MMR patent claim describes "safer measles vaccine", briandeer.com, acc 3 Jun 2010.

But the patent application does not mention Wakefield. The applicants are named as the Royal Free Hospital and Neuroimmuno Therapeutics Research Foundation, an organisation that does not appear to be connected to Wakefield or his research colleagues for the Lancet paper.

Wakefield responded to Deer's and the Dispatches allegations in a statement saying:

Since many of the claims by journalist Brian Deer have been demonstrably false and there in no objectivity in the manner of their intended portrayal, I declined to participate in any way in the making of the Dispatches programme... I was not invited to comment on the Sunday Times article prior to its publication.

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.

Resources

See also:

• Crispin Davis
• Nigel Davis
• MMR