The UK General Medical Council will this week hear charges of serious professional misconduct against three authors of a study published in 1998 in the Lancet that triggered a public health scare by suggesting a link between autism and the combined measles, mumps, and rubella (MMR) vaccine (1998;351:637-41 doi: 10.1016/S0140-6736(97)11096-0).
Andrew Wakefield, John Walker-Smith, and Simon Murch are accused of carrying out research in 1996-8 without proper ethical approval and of failing to carry out the research as described in the application to the ethics committee.
The formal charges will not be released until the case starts on 16 July, but in a statement the GMC said that the three researchers will also be accused of carrying out potentially harmful tests on the children that were not clinically indicated, including colonoscopies and lumbar punctures.
In one case, the GMC will allege, Dr Wakefield and Professor Walker-Smith “administered a purportedly therapeutic substance to a child for experimental reasons prior to obtaining information about the safety of the substance.”
On another occasion Dr Wakefield allegedly took “blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement.”
Dr Wakefield also faces charges in relation to a research grant he received from the Legal Aid Board to investigate a possible link between the MMR vaccine and autism on behalf of parents involved in litigation.
He failed to declare this funding to the Lancet. When the payment was exposed by the Sunday Times newspaper in an investigation in February 2004, the Lancet's editor, Richard Horton, declared it a “fatal conflict of interest.”
The GMC will also examine allegations of Dr Wakefield's involvement in a patent relating to a new vaccine. According to the journalist Brian Deer, whose Sunday Times and Channel 4 reports led the GMC to investigate Dr Wakefield's research, the vaccine was a potential competitor to the MMR jab.
Mr Deer told the BMJ that the GMC spent three years looking into his allegations, taking statements and materials from more than 80 sources. The case is expected to last until October.
The study and Dr Wakefield's comments at a press conference at the Royal Free Hospital, north London, in 1998, caused a collapse of public confidence in the triple jab. In the next year, rates of vaccination in 2 year olds fell from 91.5% to 87.4%. Vaccination rates fell further in 2001, to 79.9%, after Tony Blair refused to deny rumours that he had travelled to France to give his son Leo single jabs. Uptake began to rise again in 2003, and by last year 84.1% of 2 year olds were vaccinated.
In March 2004, 10 of the 13 authors of the paper signed a statement retracting its finding of a link between MMR and autism.
Dr Wakefield now lives in Austin, Texas, where he is executive director of research at Thoughtful House, a non-profit making school and clinic for autistic children. He is in the United Kingdom to attend the case. In his only interview, given to the Observer newspaper last week, he said, “My motivation is the suffering of children I've seen, and the determination of devoted, articulate, rational parents” (www.guardian.co.uk, 8 Jul, “I told the truth all along”).
Researchers from Cambridge University's autism research centre will conclude in an as yet unpublished study that autistic spectrum disorders are almost twice as common among British schoolchildren as current estimates indicate. The lead researcher, Simon Baron-Cohen, said that this study, which examined some 12 000 primary school children in Cambridgeshire, will conclude that one in 58 children has such a disorder.