THE doctor who sparked a worldwide scare over the MMR vaccine faces a six-week hearing before the General Medical Council (GMC) over allegations of serious professional misconduct, including dishonesty and intending to mislead.
A list of preliminary charges served on Dr Andrew Wakefield alleges that his research, which purported to find a possible link between MMR and autism, led to 11 different counts of misconduct.
It is claimed in the papers that he acted unethically, in a manner likely to bring the medical profession into disrepute and against the best interests of autistic child patients.
The GMC’s lawyers are halfway through a two-year inquiry into events surrounding the publication in February 1998 of a paper in The Lancet, the medical journal, written by Wakefield and 12 other doctors from the Royal Free hospital in London.
The paper triggered what was to become a worldwide alarm among parents over the safety of the combined measles, mumps and rubella vaccine. This was followed by falling immunisation levels and sporadic outbreaks of infectious diseases.
MMR vaccination in Britain had been running at 92% but after publication of the Lancet article fell to 78.9% in the first half of 2003. The most recent figures show a rise to 81.7%, although the figure for London, the area with the worst take-up, is only 70.5%.
Following a Sunday Times investigation last year, the authors of the Lancet paper, except Wakefield, retracted the claim of a possible link with autism. The journal said it regretted publishing the paper.
The GMC’s inquiry, expected to conclude at a public hearing next June, is understood to be investigating Wakefield’s work with lawyers who were trying to sue MMR manufacturers while he was apparently acting as an independent researcher.
In the original Lancet paper, the only evidence against MMR were statements by the parents of eight children who linked the vaccine with autism. The GMC is now trying to establish how many of them were lawyers’ clients.
At the heart of the GMC’s allegations is the conduct of research carried out at the Royal Free following the award of a £55,000 contract from lawyers in August 1996 to perform tests on 10 children for the Legal Aid Board. Wakefield claimed last year the £55,000 contract was for a “quite separate” study. This is called into question by confidential Royal Free documents, including letters from Wakefield himself.
These documents indicate that the lawyers’ money was initially rejected by the Royal Free’s medical school, but that Wakefield then arranged for the hospital’s management to accept it and to pay it back to his research interests. The hospital has denied any wrongdoing.
The GMC is also understood to have put it to Wakefield that he did not have approval from the hospital’s ethics committee either for including data on specific children in The Lancet or for soliciting other doctors to perform potentially hazardous tests, such as lumbar punctures.
“These tests were, however, determined and routinely carried out on the children who formed part of the study without consideration of the individual history, diagnosis, symptoms and clinical needs of the children, and without an adequate evaluation of the necessity of the tests,” the GMC papers allege.
The purpose of the research is alleged to have been to advance a theory of Wakefield’s that live measles virus in MMR damages the gut, allowing large molecules derived from food to enter the bloodstream and then damage the brain.
Other allegations levelled at the 49-year-old former gut surgeon include that he called for a boycott of MMR without clear evidence that the vaccine could cause harm; that he knew children were recruited to his research through anti-vaccine pressure groups; that he retained and used human tissues without consent; and that he failed to answer questions from the government’s chief medical officer.
Sources indicate that in recent months additional complaints have been levelled at Wakefield by senior doctors and scientists, questioning much of his research since the early 1990s. These are understood to include claims that MMR and related vaccines may be responsible for the inflammatory bowel disorder Crohn’s disease, and other research papers, in The Lancet and elsewhere, making claims about autism.
Since leaving the Royal Free “by mutual agreement” in 2001, Wakefield has worked mainly in America, where he continues to campaign against MMR. He has also started a business in Austin, Texas, to carry out research on autistic children.
Wakefield, through his lawyers, declined to comment this weekend on the GMC’s allegations, but it is understood he denies any misconduct and insists he has acted properly.
Earlier this year he said through lawyers that the Lancet paper was “a report of findings of tests which had been performed solely on the basis of clinical need” and therefore did not require ethical approval. He denied any conflict of interest over the legal funding.
A statement on the website of his Texan company said this weekend: “Despite continued misrepresentations in the media on his work, he and his collaborators continue to focus on evidence-based medicine and the clinical histories of the children that are affected.”
The GMC declined to comment on the documents but said preparation of the case was continuing.