MMR: Investigating the interests

Dr Andrew Wakefield is not the only person with questions to answer following The Sunday Times’ revelations that he failed to disclose a conflict of interest in his February 1998 Lancet paper that launched the MMR-autism scare.

According to a major investigative feature by Brian Deer, in 1996 Dr Wakefield was retained by the solicitor Richard Barr to carry out investigations on a number of children with autism and bowel problems (1). The object of these investigations was to confirm parents’ claims that their children’s behavioural and digestive symptoms had been caused by the MMR vaccine, so that they could claim compensation from the vaccine manufacturers.

It appears that four or five of the children included in the series of 12 cases reported in the Lancet were in the group represented by Barr. Though Dr Wakefield received some £55,000 out of legal aid funding secured by Barr, he did not disclose this either to his colleagues at the Royal Free Hospital in London or to Dr Richard Horton, the editor of the Lancet. Dr Wakefield accepts that these allegations are true, but he denies that this funding caused any conflict of interest, a view described by Dr Horton as ‘perverse’.

Though I have been critical of Dr Wakefield’s Lancet paper and of his campaign against MMR, I would rather that it was rejected for its scientific deficiencies rather than through the author being personally discredited. (Long before these revelations, I argued that this paper should not have been published because of its highly speculative and methodologically flawed character.) Yet Dr Wakefield and his supporters have been very quick to allege conflicts of interest (or worse) in response to anybody who criticises their position. Now they seem fated to become victims of the climate of acrimony around MMR that their activities have done much to foster.

The exposure of Dr Wakefield’s close links with the anti-MMR campaign long before the publication of the Lancet paper, and of his financial stake in any MMR-autism link, helps to clear up two curious features of this paper. One is the question of how the cases included in the study were selected. Another is why Dr Wakefield was so determined to push the MMR link far beyond the available evidence.

‘Consecutive cases’?

In their critical commentary on the Wakefield paper (published in the same issue of the Lancet), US vaccine specialists Robert Chen and Frank DeStefano pointed out that the report was based on ‘cases referred to a group known to be specially interested in studying the relation of MMR vaccine to IBD [inflammatory bowel disease], rather than a population-based study’ (2). This ‘selection bias’ meant that the study’s findings could not be considered typical of children with autism.

The Wakefield paper indicates that the 12 children were ‘consecutively referred’ to the department of paediatric gastroenterology at the Royal Free (3). It is now clear that some of these children did not turn up at random, or even simply in response to prior publicity for the Royal Free team’s work, but were already in contact with Dr Wakefield through his work for the anti-MMR legal campaign. Dr Wakefield’s colleagues may have believed that their clinics were suddenly being flooded with autistic children with digestive complaints; Dr Wakefield knew that these cases were a direct result of the anti-MMR litigation campaign for which he was a paid adviser.

The MMR link

The Lancet paper contains two quite distinct elements. The first is that it describes a distinctive pattern of bowel inflammation that it terms ‘autistic enterocolitis’. The Royal Free group has published further papers on this condition, and there have been claims of similar findings elsewhere (unfortunately, largely unpublished). Though the existence of ‘autistic enterocolitis’ remains contentious, this is generally regarded as a subject worthy of further study.

The second element of the Lancet paper is the speculation that ‘autistic enterocolitis’ may be caused by MMR. The more closely this link is examined, the more bizarre its inclusion appears. The paper presents no evidence for a link – it merely reports the conviction of the parents of eight of the 12 children that their symptoms appeared shortly after receiving the vaccine. It then suggests a complex causal pathway: MMR causes chronic measles infection provoking an auto-immune bowel disease; an inflamed bowel leaks toxic peptides; circulating toxins cause brain damage, resulting in autism. In the six years since the publication of this paper, not a single step of this hypothetical causal sequence has been substantiated.

It has long been clear that the MMR aspect of the Lancet paper was Dr Wakefield’s personal preoccupation. (Though his earlier claim that measles causes inflammatory bowel disease was rejected by subsequent researchers, it seems that Dr Wakefield still clings to this belief.) The Sunday Times account indicates that, prior to publication, there was a debate in which Dr Wakefield’s co-authors expressed reservations about reporting the parents’ belief that MMR was to blame when they had no evidence for this.

Not only did Dr Wakefield prevail in including the MMR link in the paper, at the press conference at which it was launched he further defied his colleagues’ advice and called for the suspension of MMR and the provision of separate vaccines. This headline-grabbing proposal is not included in the paper and is in no way supported by it – or indeed by research or practice anywhere in the world. It was immediately disowned by the three paediatricians on the team, Professor John Walker-Smith, Dr Simon Murch and Dr Mike Thomson.

Cui bono? Who benefited from the inclusion of the speculative MMR link in the Lancet paper? Far the greatest beneficiary was Richard Barr, or at least his firm Alexander Harris (The Sunday Times estimates that it cleared around £5million of the total of £15million spent in legal aid before the Legal Services Commission stopped this gravy train in September 2003). Dr Wakefield’s insistence on keeping the MMR link in the paper and making it the central theme of the press conference ensured a steady flow of parents of autistic children into Barr’s office – and legal aid funds into his litigation campaign.

Barr’s generous investment in Dr Wakefield’s work certainly did not discourage him from keeping the anti-MMR flag flying. The private GPs and clinics that have successfully exploited the scare by selling separate vaccines at exorbitant prices to anxious parents have also profited greatly (and while Dr Wakefield lies low, they can be relied upon to speak up on behalf of their benefactor).

What sort of inquiry?

In response to The Sunday Times story, health minister John Reid has called for the General Medical Council to investigate the allegations against Dr Wakefield. Recognising the wider issues involved, the Liberal Democrat MP Dr Evan Harris has proposed an independent judicial inquiry. There are certainly a number of issues that remain unresolved.

What is now the status of the Lancet paper? Dr Horton concedes that if he had been aware of Dr Wakefield’s conflict of interest he would not have published it. This would seem to fall short of a formal withdrawal of the paper. The honourable course would now be for Dr Wakefield to withdraw the paper, though the defiant statements attributed to him suggest that this is unlikely to happen. It is then left to his co-authors, many of whom have already publicly distanced themselves from Dr Wakefield – and have told The Sunday Times of their anger at being kept in the dark over his legal aid funding – to withdraw their names from it.

The argument that, notwithstanding Dr Wakefield’s conflict of interest, the findings of the paper still stand is, like Dr Wakefield’s self-justification, perverse. Declarations of interest are not merely a formality with no relevance to the content of research: if the leading researcher in a scientific study has a personal financial interest in the outcome of the study, then this may well influence the outcome.

Were the investigations clinically justified? The children included in the Lancet study were subjected to intensive and invasive investigations, including ileo-colonoscopy, lumbar puncture, blood and urine tests, EEG and MRI scans. Dr Wakefield and his colleagues continue to maintain that these investigations were justified on clinical grounds. Their claim that any child who presented with such symptoms would be investigated with similar rigour should be examined by specialists in the relevant disciplines. Until the recent revelations, critics wondered whether these investigations were carried out for the purposes of research rather than clinical need. Now the question arises whether an additional concern was to gather evidence of vaccine damage for the purposes of claiming compensation.

Why has it taken six years for this scandal to emerge? Here the publications of the same newspaper offer a striking contrast. Brian Deer’s article stands in the best traditions of investigative journalism. His interrogation of the MMR controversy was undoubtedly influenced by his brilliant work on the whooping cough vaccine scare; the parallels between the anti-vaccine campaigns are striking (4). His forensic rigour may not have endeared him to Dr Wakefield and his supporters, or even to staff at the Royal Free and the Lancet, but it has dramatically exposed the truth about the MMR scare – that it is based on a paper that is worthless.

Yet only a few weeks ago, The Sunday Times published a major feature on the MMR controversy which was little more than a presentation of the familiar gospel according to Dr Wakefield and the anti-MMR campaign (5). Robert Sandall, rock critic and biographer of David Bowie, even presented an apologetic account of the decision to fly seven autistic children to Detroit for lumbar punctures (rejected on ethical grounds by every BUPA hospital in Britain), the grotesque finale of the Barr-Wakefield campaign (6). In its acceptance at face value of Dr Wakefield’s self-proclaimed ‘maverick’ status, its uncritical approach to the anti-MMR campaign and in its ill-informed hostility towards Dr Wakefield’s critics, Sandall’s article is typical of much press commentary on the MMR issue. It is also typical in that Sandall was commissioned to write the article though he has no special knowledge or experience in matters of health or science, immunisation or autism; his sole qualification is that he has a baby daughter.

The clues followed up by Brian Deer were there for any serious investigative journalist who cared to look for them. In December 1995, The Sunday Times magazine published a substantial anti-MMR feature that provided an early stimulus to the campaign (7). This article details claims that measles vaccination (singly, or in the forms of MMR or as MR, given to schoolchildren in a major campaign in November 1994) may cause a wide range of adverse effects, including inflammatory bowel disease and autism. It introduces the anti-vaccination campaign JABS, the anti-MMR campaigning solicitor Richard Barr – and provides a detailed account of the work of Dr ‘Andy’ Wakefield at the Royal Free Hospital.

A photo of Dr Wakefield is captioned ‘Andy Wakefield is convinced that Crohn’s disease can be linked to the measles vaccine’. In 1998, Richard Barr and his close collaborator Kirsten Limb published their ‘information pack’ for parents, the first manifesto of the anti-MMR campaign, which records that they were ‘working with Dr Wakefield of the Royal Free Hospital, London’ (8). In May 2002, Private Eye published the campaign’s second manifesto (9). This records how Rosemary Kessick, mother of an autistic son and a prominent anti-MMR campaigner, contacted both Barr and Dr Wakefield in 1996, in relation to her own son. It describes further how ‘she [Mrs Kessick], Richard Barr and JABS parents then asked Wakefield and his team if they would look at other autistic children who appeared to have identical bowel problems’. In other words, the children who were referred to the Royal Free – some of whom were included in the Lancet paper – were a more highly selected group than anybody at the Royal Free (apart from Dr Wakefield) – knew.

The fact that, before Brian Deer, nobody bothered to pursue these clues does much to explain the impact of the MMR scare. In a climate of opinion that is highly sensitive to health risks and increasingly distrustful of expert opinion, many journalists wanted to believe Dr Wakefield. This meant that they suspended any critical or investigative instincts in relation to the campaign against MMR. As a result, one speculative paper, now utterly discredited, has had the effect of reducing the uptake of MMR far below that required to maintain community resistance to measles, mumps and rubella.

Why did the Legal Aid Board (now the Legal Services Commission) agree to support claimants for compensation for autism resulting from MMR before any such link had been established by scientific research? By September 2003, some £15million had been spent, much of it on research commissioned by Barr and conducted by Dr Wakefield and others, with the result that a link between MMR and autism could not be established in a single case.

The failure of the research into MMR led the commission to the sober conclusion that ‘in retrospect, it was not effective or appropriate for the LSC to fund research’ (10). It emphasised that ‘the courts are not the place to prove new medical truths’. Surely this is a conclusion that ought to have been obvious from the outset? This extraordinary deployment of legal aid funding has led to the corruption of medical research and has helped to sustain a scare about MMR that has been damaging to public health and has caused great distress to families affected by autism – and not only to those whose children have been dragged through invasive investigations and have been left with nothing, while lawyers and expert witnesses have pocketed millions.

Dr Michael Fitzpatrick is the author of MMR and Autism: What Parents Need to Know, Routledge, 2004 (buy this book from Amazon (UK) or Amazon (USA)); and The Tyranny of Health: Doctors and the Regulation of Lifestyle, Routledge, 2000 (buy this book from Amazon UK or Amazon USA). He is also a contributor to Alternative Medicine: Should We Swallow It? Hodder Murray, 2002 (buy this book from Amazon (UK) or Amazon (USA)).

Read on:

(1) ‘MMR: the truth behind the crisis’, Brian Deer, Sunday Times, 22 February 2004

(2) ‘Vaccine adverse events: causal of coincidental?’, RT Chen and F DeStefano, Lancet 351, 1998, p611-2

(3) ‘Ileal-lymphoid-nodular hyperplasia, non-specific colitis, and pervasive developmental disorder in children’, Andrew Wakefield et al, Lancet 351, 1998, p637-41

(4) DTP/DPT: the vanishing victims, Brian Deer, Sunday Times, 1
November 1998

(5) ‘MMR RIP?’, R Sandall, Sunday Times, 14 December 2003

(6) Medicine on trial, by Dr Michael Fitzpatrick

(7) ‘A shot in the dark’, Y Roberts, Sunday Times, 17 December 1995

(8) Measles, mumps, rubella vaccines (MMR or MR): information pack, R Barr and K Limb, Hodge, Jones and Allen (solicitors), (1998) now available at Alexander Harris

(9) ‘MMR: the story so far’, H Mills, Private Eye, 2002

(10) Decision to remove funding for MMR litigation upheld on appeal, Legal Services Commission, 11 September 2003