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# 8.2 An acrimonious debate

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

There were two unusual aspects to the publication of the Wakefield paper and both contributed to the subsequent furore. The first was that it was accompanied by a critical commentary by Robert Chen and Frank DeStefano, two American vaccine specialists (Chen, DeStefano 1998). The second was that it was launched at press conference at the Royal Free Hospital. Let us look at these in turn. As Richard Horton, editor of The Lancet, has indicated in his reflection on the ‘acrimonious debate’ that erupted following his decision to publish the Wakefield paper, he was well aware of its controversial character (Horton 2003: 207). The substance of Dr Wakefield's MMR-autism thesis had already been widely leaked and The Lancet's peer reviewers had raised concerns about the study's methods and interpretations, as well as about the dangers of undermining public confidence in immunisations. Dr Horton insisted that the paper was revised to clarify that its authors had no proof that MMR caused autism, following which it was published under the label of ‘early report’ to ‘highlight its preliminary nature’ (Horton 2003: 208). Furthermore, he commissioned two US vaccine experts, Robert Chen and Frank DeStefano to write ‘Vaccine adverse events: causal or coincidental?’ – a brief but devastating critique of the Wakefield paper published in the same issue of The Lancet (Chen, De Stefano 1998).

Chen and DeStefano first indicated the excellent safety record of MMR in hundreds of millions of people worldwide over three decades. They questioned whether the newly identified syndrome of autistic enterocolitis could be considered clinically distinctive: ‘no clear case-definition was presented, a necessary requirement of a true new clinical syndrome and an essential step for future research’ (Chen, DeStefano 1998: 612). They emphasised that the authors had not confirmed the presence of vaccine virus in the tissues of their patients. They suggested that ‘selection bias’ might have resulted from the referral of children to the clinic of ‘a group known to be specially interested in studying the relation of MMR vaccine with inflammatory bowel disease’ (Chen, DeStefano 1998: 612). They noted that it is usually difficult to date precisely the onset of a syndrome such as autism, and wondered whether ‘recall bias’ may have resulted from parents attempting to relate the onset of their child's problems to an unusual event such as a coincidental vaccine reaction. They also pointed out that, although Dr Wakefield and his colleagues postulated that MMR might lead to inflammatory bowel disease, which, in turn, might cause autism, in almost all the cases reported in their paper behavioural changes preceded bowel symptoms. The time course of these pathological processes was also curious: in one case the effect of MMR on behaviour was evident within 24 hours – faster than any known process of infection-induced vasculitis (the underlying pathology postulated as the cause of ‘autistic enterocolitis, a type of process that unfolds over several weeks).

In conclusion, Chen and DeStefano warned presciently that, if claims of adverse events resulting from vaccines were not properly substantiated, there was a danger that vaccine-safety concerns may ‘snowball into societal tragedies when the media and the public confuse association with causality and shun immunisation’ (Chen, DeStefano 1998: 612). Many of these themes were taken up and expanded in subsequent letters to The Lancet.

In retrospect, Dr Horton conceded that the publication of Dr Wakefield's paper in The Lancet gave it ‘more credibility than it deserved as evidence of a link between the MMR vaccine and the new syndrome’ (Horton 2003: 209). Yet, while he defended his decision to publish the paper, he unreservedly admitted to ‘a failure to manage the media reaction’ – a failure that started with the now notorious Royal Free press conference.

The press conference was an extraordinary event. Journalists were treated to a special introductory video prepared by the Royal Free press office and the Dean of the Medical School, Professor Arie Zuckerman, himself a vaccine specialist, presided over the conference. (Professor Walker-Smith refused to attend, indicating that he disapproved of medical research being debated prematurely in the mass media. He has recalled that the only enthusiasm for the conference came from Dr Wakefield and his staunch ally Professor Roy Pounder, senior adult gastroenterologist at the hospital [Walker-Smith 2003: 241].)

Dr Wakefield seized the next day's headlines with his sensational recommendation that parents should reject the MMR immunisation and give their children each of the three components separately, 12 months apart (The Times, 27 February 1998, Daily Telegraph, 27 February 1998). This recommendation was not included in the Lancet paper and is in no way supported by it. Such a programme of vaccination has not been introduced anywhere in the world and there is no evidence to justify any particular interval between vaccinations. It was immediately repudiated by Professor Zuckerman and by the paediatricians in the Wakefield team. Dr Simon Murch, Dr Mike Thomson and Professor Walker-Smith subsequently wrote to The Lancet to disassociate themselves from Dr Wakefield's call for separate vaccines (Murch et al 1998). Not a single member of the team publicly endorsed Dr Wakefield's anti-MMR stand. Yet, as the press conference broke up in rancour, the campaign against MMR received its biggest boost so far.

Five years later Richard Horton was still smarting from the ‘vituperative attack and personal rebuke’ he experienced as a result of his decision to publish the Wakefield paper (Horton 2003: 213). Many critics complained that The Lancet's process of peer review should have exposed the weaknesses of the paper and prevented its publication. Dr Horton insists that the role of peer review is not to judge the validity of a piece of research – that can only be verified by other scientists – but to comment on the importance of the issue under investigation and on the design and execution of the study (Horton 2003: 213). He decided to publish Wakefield's paper, not because he believed it to be true, but because it raised an important question that required urgent verification. Dr Horton has argued the important principle that medical journals must uphold free expression in scientific debate even if this creates problems for public health. He maintains that to have refused to publish Wakefield would have been an act of censorship. But, as Chen and DeStefano and many others have pointed out, there were basic errors in design, execution, analysis and interpretation in the Wakefield paper. Dr Horton indicates elsewhere that, every year, The Lancet publishes 500 out of 10,000 papers that are submitted: this is not censorship but editorial judgement (Horton 2003: 307). Indeed, when Dr Wakefield submitted his follow-up paper, including a further 48 cases, Dr Horton exercised this discretion and rejected it (it was finally published in the American Journal of Gastroenterology; Wakefield et al 2000).

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