By Adam Smith
Science & Communications Officer, ANH-Intl

In the ongoing Wakefield saga, it often feels as though everything is done and dusted; that Andrew Wakefield’s accusers have proven themselves correct and that the perpetrator of a tremendous medical fraud has rightfully been exposed and punished. That is, without a doubt, the impression given by the mainstream media, which have arranged themselves like a Roman army behind Brian Deer and the UK’s General Medical Council (GMC), not a chink of light between their shields.

But there is another story to be told here. Wakefield wrote a book giving a detailed account of his point of view, which he called Callous Disregard in an ironic echo of the GMC’s judgement of his conduct toward the autistic children involved in the story. In a healthy society, this book would have been reviewed widely and read without prejudice, as befits the story of the man accused of possibly the UK’s most heinous medical fraud. As it was, the book received no attention in any mainstream publication – but some inkling of its effect on public opinion can be gleaned from the subsequent series of articles by Brian Deer in the British Medical Journal (BMJ). These articles repeated once more the full range of accusations against Wakefield, but this time in a prominent medical journal, thereby giving Deer’s allegations official recognition and respectability.

One of our readers crystallised some of the key arguments around Andrew Wakefield in a comment addressed to one of our recent articles. In the interests of open debate, we answered his queries in full in an attempt to show that, at the very least, there are two sides to this immensely complex story. We are reproducing the correspondence here to bring the debate into the public arena. And to advertise our forthcoming features on the Wakefield episode, of course!

Reader comment by Tim Webb

There is some confusion here. There may well be a perception that AW was struck off the Register for questioning vaccine safety and efficacy; and that may well underlie the action. However, reference to the headline British Medical Assocation (BMA) charges against him reveals prima facie evidence for unethical conduct, which by and of itself has to undermine anything he might say scientifically.

Specifically, he gave small sums of money to his own son, and also to other children present at his son’s birthday party, in payment for blood samples. He also took £50,000 from the Legal Aid Board, part of which he then spent to pay for services freely available under the NHS. Other sums were spent in ways not declared under the terms of his original application for those funds. He did not declare this financial contribution to the editor of the Lancet; clearly this placed his scientific findings in potential conflict with his financial interests. One can therefore see why Brian Deer might have valid reason to comment on the AW story. This is not simply a medical/scientific issue.

AW is perceived by the general public as being a champion of the common man against the big business interests of the pharmaceutical industry. However, one should realise that he is himself a man who has patented a "single-shot" measles vaccine. If the triple-shot MMR vaccine is shown to be dangerous, which is quite possibly the case, then AW will stand to gain financially, on a fairly massive scale, should his vaccine be cleared for world-wide use. He is not simply therefore a disinterested medical scientist; and the whole issue should be considered in the light of that caveat.

Reply by ANH-Intl

Thanks for your comment, Tim. We agree that the Wakefield case goes beyond merely the scientific and extends heavily into political, financial and personal spheres. We have spent some considerable time looking into the allegations made against Wakefield, mainly by Brian Deer (and subsequently taken up by the GMC), and examining how they compare against Wakefield’s side of the story presented in his book, Callous Disregard, and elsewhere. There will be an ANH feature or two on this in the near future, but since you have identified some of the most crucial non-scientific accusations against Andrew Wakefield, we’d like to address them here.

An error of judgement

Firstly, right from the off, it appears the ‘birthday party’ incident was, at the least, a gross error of judgement on Wakefield’s part. In fact, he compounded the initial mistake by using the episode in presentations he made to various audiences, and made things even worse for himself by treating the subject as a joke. Wakefield has admitted as much in interviews, saying “There was no approval to do it and nor did I think approval was necessary because it was done away from the Royal Free…that was naive and nowadays you would definitely need ethical committee approval, and you probably did then.” Not only was Wakefield’s conduct startlingly naïve, but it laid him open for attacks on his professional integrity, which have duly followed.

The Legal Aid Board money

A £50,000 payment was made to Wakefield by the Legal Aid Board (LAB), of that there is no doubt. According to Callous Disregard, Wakefield was asked in the first half of 1996 for help by Richard Barr, of Dawbarn’s law firm, to “Review the safety of measles-containing vaccines (MCV) and, separately, to design a study that would help determine whether there was or was not a likely case in law against the manufacturers of MCV.” Crohn’s disease was the original focus of interest in terms of adverse vaccine reactions, but this later shifted to autism in children with intestinal symptoms. According to Callous Disregard – and this is an utterly crucial point – the £50,000 did not fund the Lancet 1998 paper (the case series of 12 children that was retracted in 2010), but “…an entirely separate scientific study looking for evidence of measles virus in the diseased intestine of affected children”.

Wakefield prepared a research proposal for Barr’s submission to the LAB, a proposal that was subsequently accepted, with grant money being administered from a designated research account and not from Wakefield’s ‘back pocket’. Wakefield did not hide the existence or the source of the grant from the Royal Free Hospital School of Medicine, his employers at the time, immediately informing the finance department – strange behaviour for a man who purportedly had something to hide, particularly a man who supposedly had manifested a complex plan to discredit UK vaccine policy and then make a profit.

The ethics committee of the BMA itself wholly approved the LAB funding of Wakefield’s research at the time. In response to a query from Zuckerman, Dr Mac Armstrong, the BMA ethics committee chairman, stated it was “…quite logical for the [LAB], as a publicly funded body to fund research on relevant issues in law, using government money essentially to sue other government departments. Independently conducted research may establish whether or not they have a case in law and is no different from commissioning a medical expert to provide a view.”

True, Wakefield did not declare the LAB funding to the Lancet at the time the 1998 article was submitted for publication. At that time, however, such disclosure was not necessary: the Lancet’s disclosure rules only required that authors declare direct conflicts of interest, such as funding by a pharmaceutical company for research into one of their drugs. The LAB grant could only have led to a perceived conflict of interest as it related to the 1998 Lancet paper, as it was for research by one author of 13 into a related, but distinct, subject to that of the 1998 paper. At the time, authors were not required to disclose perceived conflicts of interest, although this has since changed.

Deer and the BMJ

Without knowing the details of the other allegations you mention – that Wakefield spent money on services that were free on the NHS, or that he spent money on things not declared in the original research application – we cannot comment further on them. With regard to Deer, however, of course anyone is entitled to comment on any aspect of the Wakefield case as they see fit; that is what free speech is all about. What we do question is a journalist with no medical qualifications being given a three-part article in the BMJ to reheat prior accusations against a man already hounded from his job and his country. This is an entirely unique situation that sees the UK doctors’ trade union, the British Medical Association, using its wholly owned publishing arm, the BMJ, to continue a vendetta against one of its ex-members. We do not anticipate the BMJ giving any space to Wakefield to counter Deer’s accusations any time soon, and certainly not to the extent afforded Deer.

Wakefield’s vaccine

The issue of Wakefield’s own single-shot MMR vaccine is an interesting one. In June 1997, Wakefield lodged a preliminary application for a patent on “A pharmaceutical composition for the treatment of an MMR virus mediated disease comprising a double dialysed leucocyte extract containing a transfer factor”, which could beadapted for use as a vaccine for the prophylaxis of measles virus”. On the surface, this seems pretty damning. However, there are other factors to consider, such as the attitude of Wakefield’s employers and the government over commercialisation of research findings.

In a statement released by Wakefield in answer to Deer’s accusation that he patented his own vaccine ready to profit when the existing MMR vaccine was discredited, he said: “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… it was our intention, at one stage, to conduct a formal therapeutic clinical trial of a compound [transfer factor] 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…. 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.

We would be very interested to see the “contemporaneous documentation” that Wakefield refers to here, and in the closing chapters of Callous Disregard, he hints that a future volume will go into detail on this topic.

And speaking of detail, our features will go into far more of those when they are published, so keep looking back!

Establishment motive?

Finally, a word as to potential motive for the Wakefield witch-hunt. Who stood to be sued by the parents of vaccine-damaged children if Wakefield’s research established a link between MCV and serious adverse events? Why, the UK government, in the form of the Department of Health (DoH). The same DoH, incidentally, who approved for use on UK children a measles, mumps and rubella (MMR) vaccine that had been linked with outbreaks of meningitis in Canada and subsequently withdrawn – in the very same month that the UK government approved it.

 

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