Disciplinary committee - Erasure of name from registry - Panel finding appellant carrying out programme of investigation without ethics committee approval

Walker-Smith v General Medical Council: QBD (Admin) (Mr Justice Mitting): 7 March 2012

At the relevant time, the appellant was a professor of paediatric gastroenterology at the Royal Free Hospital. In September 1996, an application was made to the hospital’s ethics committee for approval of a research project.

The appellant was named as one of the responsible consultants together with W and M. Two working hypotheses were set out for the possible link between the measles/rubella vaccine in a previously healthy child and the subsequent development of enteritis, Cbl deficiency and disintegrative disorder. In January 1997, the appellant was notified of the approval of the project (project 172-96) subject to three conditions, including a condition that only patients enrolled after 18 December 1996 would be considered to be in the trial.

Between July 1996 and February 1997, 11 children were admitted to the hospital for investigation under the appellant and his team. The case histories of those 11 children plus a 12th child were subsequently summarised in a paper published in The Lancet. At a press conference which was contravened to accompany publication of the paper, W stated that he could no longer support the giving of the MMR vaccine. The joint view of the appellant and M was that it was inappropriate to emphasise the role of the MMR vaccine in publicity about the paper and that they supported government policy concerning MMR until more firm evidence was available.

However, W’s statement and subsequent publicity had an adverse effect upon the takeup of the MMR vaccine and this was of great concern to those responsible for public health. In October 2004, charges of serious professional misconduct brought by the General Medical Council (GMC) against the appellant, W and M, were referred to a fitness-to-practise panel (the panel). It was alleged, inter alia, that, in relation to the 11 children, the appellant had subjected them to a programme of investigation for research purposes without ethics committee approval, either because the investigations had been carried out before approval was given, or because the children’s condition had not met the selection criteria, or because they had been carried out in breach of the conditions of approval.

Further, various investigations had been clinically inappropriate. The appellant contended that he had been conducting medical practice which did not require ethics committee approval. He contended that it was his intention which was determinative of that issue. Accordingly, an unavoidable and fundamental question which the panel had to answer was the distinction between medical practice and research, and to determine what the appellant’s intention had been. In May 2010, the panel gave a written decision concluding that the appellant and W were guilty of serious professional misconduct. It was ordered that the names of the appellant and W be erased from the register of medical practitioners. The panel concluded, inter alia, that: in respect of 10 of the 12 children, the appellant had subjected them to investigations as part of project 172-96, a research project without ethics committee approval; the investigations carried out on child 2, 1, 3, 9, 5, 12 and 8 were contrary to his representations to the ethics committee that they were clinically indicated; and in seven of the 10 cases in which it found that the appellant was at serious fault, he had subjected the children to investigations which were not clinically appropriate and were contrary to their clinical interests.

Further, the panel found that the appellant had known that the reporting of a temporal link between the syndrome described and the MMR vaccination had major public health implications and would attract intense public and media interest. Consequently, as a senior author, the appellant had had a duty to ensure that the factual information in the paper and any information provided by him in response to queries was true and accurate. It found a number of failures in respect of the paper (see [156] of the judgment). The appellant appealed against the panel’s findings and the sanction. The appeal would be allowed.

Both on general issues and The Lancet paper and in relation to individual children, the panel’s overall conclusion that the appellant was guilty of serious professional misconduct had been flawed, in two respects: inadequate and superficial reasoning; and, in a number of instances, a wrong conclusion. The panel had had to decide what the appellant thought he was doing: if he believed he was undertaking research in the guise of clinical investigation and treatment, he had deserved the finding that he had been guilty of serious professional misconduct and the sanction of erasure; if not, he did not, unless, perhaps, his actions had fallen outside the spectrum of what would have been considered reasonable medical practice by an academic clinician. Its failure to address and decide that question was an error which went to the root of its determination (see [186] of the judgment).

The finding of serious professional misconduct and the sanction of erasure would be quashed (see [187] of the judgment).

Stephen Miller QC and Andrea Lindsay-Stugo (instructed by Eastwoods Solicitors) for the appellant; Joanna Glynn QC and Christopher Mellor (instructed by Field Fisher Waterhouse) for the GMC.