The doctor at the centre of a major public health scare over vaccinations gave evidence this week before a General Medical Council panel, where he and two colleagues stand accused of research misconduct.
Andrew Wakefield, whose research paper and comments in 1998 linking the combined measles, mumps, and rubella (MMR) vaccine to autism led to a sharp fall in uptake of the vaccine, told the hearing that he was motivated by concern for autistic children.
He read out a letter that he had sent in 1997 to John Walker-Smith, now also accused of misconduct by the GMC, in which he wrote: “If these diseases are found to be linked to the MMR vaccine, these children are the few unfortunate who have been sacrificed to protect the majority.”
In that letter he defended his involvement with solicitors acting on behalf of parents seeking compensation from vaccine manufacturers. Six years after the publication of a study linking measles virus to irritable bowel syndrome and autism (Lancet 1998;351:637-41), it emerged that 10 of 12 patients involved in the research had legal aid backing to sue vaccine manufacturers and that the Legal Services Commission had funded his research (BMJ 2004;329:1293; doi: 10.1136/bmj.329.7477.1293).
Dr Wakefield also received £435 643 (€550 000; $860 000) from the commission in fees to investigate and write reports on the safety of the MMR vaccine—fees that were not disclosed in the Lancet paper. When the payments became known in 2004 the Lancet repudiated the paper, and its editor, Richard Horton, said that the journal was compromised by a “fatal conflict of interest.”
Dr Wakefield denied that his research was motivated by legal or financial reasons. “The reason these parents were talking to me was nothing to do with the litigation, and litigation was not my primary concern.”
He told the hearing that when he was approached by lawyers representing the families of autistic children he had consulted the BMA to ask what the “going rate” was. “They indicated that the fee was £150 to £200 an hour,” he said. “I opted for the former of the two figures.”
The GMC alleges that Dr Wakefield was “dishonest and misleading” in applying for a further £55 000 in legal aid money to pay for treatments that would actually have been covered by the NHS. He said that that money was spent on a different study, distinct from that in the Lancet article.
“The legal aid funding was specifically and exclusively for the Legal Aid Board pilot, which would involve just five children with autism and five with Crohn’s disease,” Dr Wakefield told the hearing. “That investigation was specifically narrow, whereas our research investigation was much broader.”
Dr Wakefield also disputed allegations that while at the Royal Free Hospital, London, he conducted invasive tests, including colonoscopies and lumbar punctures, not approved by the hospital’s research ethics committee. Those tests were conducted for clinical, not research, purposes, he argued, and were beyond the remit of ethics approval.
He questioned the memory of the chairman of the ethics committee, Michael Pegg, who had denied giving ethics approval for much of his work. “In terms of the research investigations, Dr Pegg is wrong. His memory is at fault. In terms of the clinical investigations, there was no approval because there was no need,” he said.
Professor Walker-Smith, who is also facing the GMC panel accused of serious professional misconduct, decided which investigations were appropriate on the basis of clinical need, said Dr Wakefield.
Dr Wakefield is also accused of paying £5 each to children at his son’s birthday party for blood samples. He allegedly joked while speaking at a conference in the United States that some of the children, as young as 4 years old, had fainted afterwards.
He is also accused of repeatedly injecting one child with an experimental drug called transfer factor without ethics approval. Transfer factor was a proposed alternative to MMR vaccine in which he had a financial interest, the GMC alleges.
A third consultant at Royal Free Hospital, Simon Murch, is also accused of participating in unapproved and unnecessary invasive procedures as part of the research. Professor Murch wrote to the Lancet in 2003 repudiating Dr Wakefield’s claims about MMR vaccine, calling him “completely wrong” and suggesting that “his focus is not that of a paediatrician any more.”
Dr Wakefield now lives in Austin, Texas, where he is director of Thoughtful House, a centre for children with developmental disorders, but he has returned to Britain to attend the GMC hearing.
His testimony continues.