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# 8.6 Moving the goalposts

Fitzpatrick, M. (2004) Chapter 8 ‘The Lancet Paper’ taken from MMR and Autism: What Parents Need to Know, London, Routledge. Copyright © 2004 Michael Fitzpatrick.

> If these researchers are able to prove cause and effect between immunisation and the described syndrome, they should do so straight away. If they are unable to do so they should publicly set the matter straight lest the health of our nation's children suffers.

> (Lindley, Milla 1998)

This challenge to Wakefield and his colleagues was issued by two senior gastroenterologists at Great Ormond Street Hospital for Children in immediate response to the Lancet paper in February 1998. Five years later Wakefield and his colleagues had still neither proven their hypothesis, nor withdrawn it.

In response to the failure of research in the two areas recommended in the Lancet paper – epidemiology and virology – to substantiate his hypothesis, Dr Wakefield continued to support the campaign against MMR, while redefining his case for its causative role in autism. At the outset, the concept of MMR-induced ‘autistic enterocolitis’ was advanced to explain a dramatic increase in the incidence of autism (the ‘autism epidemic’). Before long, however, a close temporal association between MMR and the onset of behavioural regression – at first regarded as a significant indicator of causation – was relaxed and then abandoned. When epidemiological studies still failed to substantiate a link, Dr Wakefield hypothesised that MMR caused ‘autistic enterocolitis’ in a subset of children, rendered vulnerable by a combination of genetic and environmental factors (including food allergy, antibiotic use, ear infection, multiple concurrent vaccine exposure, a strong family history of atopic and auto-immune disease, and exposure to mercury) (Wakefield 2001b). (This list of possible cofactors in the aetiology of autism – familiar from our account of unorthodox biomedical approaches to autism – reflects Dr Wakefield's growing reliance on parent activists and anti-immunisation campaigners.)

In a response to a Danish epidemiological study (published in the New England Journal of Medicine in November 2002) that failed to show any link between MMR and autism, Dr Wakefield argued that this subset may be ‘no more than 10 per cent of diagnoses’ (Madsen et al 2002, Wakefield 2002b). In a subsequent letter to the journal, Dr Wakefield appeared to give up on epidemiology, arguing that the effect of the number and complexity of cofactors was ‘to reduce statistical power to the extent that such studies fail to offer any convincing evidence either way’ (Wakefield 2002b). Or as he put it in a newspaper interview in March 2003, ‘retrospective studies like this are meaningless’ (Phillips 2003: 43). But it was retrospective studies such as this that Wakefield specifically invited in his Lancet paper.

The end result of this process of shifting the goalposts is that MMR, once blamed for producing an autism epidemic, is now said to be a factor in causing autism in a number of cases too small to discern by epidemiological methods. If this is so, how can MMR have caused autism in more than 1,000 cases currently pursuing compensation under the leadership of Richard Barr (with expert medical advice from Dr Wakefield)? We know that such methods of study are capable of detecting rare adverse effects of immunisation, such as ITP at a rate of one in 32,000 vaccinations (around 20 cases a year), so detecting a subset the size of 10 per cent of all cases of autism should be fairly straightforward.

Given the failure of epidemiology to confirm his hypothesis, Dr Wakefield has counter-posed the need for clinical studies – a call loyally echoed by his anti-MMR campaign followers. But populations are made up of individuals: if an effect of MMR – a vaccine administered at a population level – cannot be discerned at a population level, then it does not exist. Furthermore, Dr Wakefield's attempts to substantiate his hypothesis at a clinical level, in collaboration with Professor O'Leary, have also failed to bear fruit.

Unfortunately, instead of accepting the failure to prove their hypothesis, and – in the interests of public health – withdrawing it, Wakefield and his supporters have doggedly and dogmatically continued to proclaim their conviction that MMR causes autism in some children, in defiance of all evidence to the contrary.

As the anti-MMR campaign found itself on the defensive, its supporters mounted increasingly personal attacks on critics of the Wakefield position. Brent Taylor and Elizabeth Miller, whose epidemiological work provided the most powerful defence of MMR, came in for particular vilification. In response to their 1999 paper, for example, Allergy-induced Autism issued a scurrilous denunciation of these authors, accusing them of ‘a cynical attempt to disguise the truth’ and of perpetrating ‘a scandalous public dupe of BSE proportions’ (AiA 1999). It demanded the resignation of ‘all key members of the study group’ insisting that such an ‘attempt to justify health policy by using inadequate research as propaganda is reprehensible’. The criticisms of the Taylor study made by AiA were the same as those made by Dr Wakefield in a slightly more restrained letter to The Lancet. In his testimony to the US senate committee hearing in April 2000, Dr Wakefield claimed that the Taylor paper was the subject of a ‘highly critical’ debate at the Royal Statistical Society in London, which concluded that the ‘study design was wrong’ (Wakefield, Montgomery 2000). In fact no such debate took place and the Royal Statistical Society came to no Conclusion about the design or validity of the study. This study was described by the US Institute of Medicine's immunisation safety review as ‘the most extensive epidemiological study and the strongest published evidence against the hypothesis that MMR causes ASD [austistic spectrum disorder]’ (Institute of Medicine 2001: 44).

As the debate became increasingly polarised, Wakefield and his supporters resorted to impugning the motives of critics of the campaign against MMR by alleging conflicts of interest arising from their links with vaccine manufacturers. Two distinct issues thereby became confused.

First, as a result of the class action against the manufacturers of MMR, the pharmaceutical companies concerned were obliged to seek expert advice from the small pool of specialists in the relevant disciplines. These specialists received fees for their services, in the same way that expert witnesses for the plaintiffs received fees from the Legal Aid funds secured by Richard Barr and his team. Though payments should be disclosed where there is any question of a conflict of interests, the notion that the receipt of such fees implies a loss of professional discretion and integrity is both absurd and offensive. Given the low profile of pharmaceutical companies in paediatrics or autism, it is highly unlikely that any of these specialists would have become ‘drug company advisors’ if it were not for the activities of the anti-MMR campaign.

Second, paediatricians or immunologists who are engaged in research or clinical trials of vaccines are obliged to do this work in collaboration with pharmaceutical companies, since virtually all vaccines are manufactured by such companies. It is standard practice that researchers are excluded from investing for personal gain in companies sponsoring their research. However, although they may not gain personally, professional success is to some extent dependent upon generating research funding, so it is legitimate to declare this interest. According to Adam Finn, professor of paediatrics at the University of Bristol, such declarations should be interpreted as a qualification to give a well-informed opinion, ‘as anyone unable to declare such competing interests is unlikely to have had any direct experience of using new vaccines in children’ (Finn 2002: 733). However, in the rancorous climate generated by the MMR controversy, anti-MMR campaigners have presented such declarations of interest – available on easily accessible official websites – as though they were investigative journalists uncovering conspiracy and corruption. Although the implication that everybody is governed by the most venal motives is widely held in modern society, it is corrosive of any kind of civilised discourse.

Populist jibes against the drug companies are a recurrent theme among campaigners against all forms of immunisation. No doubt the pharmaceutical corporations, like all capitalist enterprises, are more concerned about their profitability than the welfare of their consumers. There are many areas in which they can be legitimately accused of profiteering, disease-mongering and sharp practice (see Moynihan et al 2002). Yet the provision of vaccines, a relatively low-volume and low-profit sector, is not one of them. Indeed it is an area characterised by low investment and declining innovation, partly as a result of the climate of risk aversion and litigiousness, particularly in the USA (Galambos 1999). In August 2003 a report by the US Institute of Medicine complained of supply problems resulting from the declining number of vaccine manufacturers and urged the government to subsidise vaccine costs (Institute of Medicine 2003). The report noted the relatively small size of the vaccine market in the USA and the fact that vaccines accounted for only 1.5% of global pharmaceutical sales. Companies complained that their return on investment was small and there was little incentive towards research and development. In a contribution to a conference on vaccination in the USA in October 2003, Richard Gallagher, editor of The Scientist, noted that ‘vaccinations are unattractive targets for industry, under-appreciated from the public health perspective, underfunded by basic research organisations, and treated with suspicion by the public’ (Gallagher 2003). He commented on the ‘malign influence’ of three groups – anti-vaccination lobbyists (whose ‘ignorant’ websites included contributions from ‘health nuts, conspiracy theorists and misguided physicians’), journalists (who wrote ‘badly-researched and poorly-argued scare stories’) and lawyers. At the same conference, vaccine specialist Neil Halsey noted that class action lawsuits led to large damage awards and complained that the courts provided a forum for ‘junk science’ in the guise of expert testimony (The Daily News, 27 October 2003).

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