Dr Andrew Wakefield 'to be charged with serious professional misconduct'|
LONDON, UK: The British doctor who first suggested a link between the triple MMR vaccine and autism is to be charged with serious professional misconduct, it is reported.
The Independent newspaper reports that the General Medical Council will accuse Dr Andrew Wakefield of carrying out "inadequately founded" research.
Vaccination rates fell sharply after Dr Wakefield questioned the safety of MMR, raising fears of a measles epidemic.
His initial paper in The Lancet has since been disowned by the journal. The editor admitted he would not have published the 1998 paper if he had known about what he called a "fatal conflict of interest."
Dr Wakefield was being paid to see if there was any evidence to support possible legal action by a group of parents who claimed their children were damaged by the vaccine. Some children were involved in both studies.
In addition, ten doctors who co-authored the paper issued a statement in 2004 arguing there was insufficient evidence to draw the conclusion that the MMR vaccine was not safe.
The main thrust of the paper was that MMR was linked not only to autism, but also to the bowel disorder Crohn's disease.
A host of major studies has since failed to find any evidence of a link between MMR and autism. However, the uptake rate for MMR - a combined jab which protects against measles, mumps and rubella - slumped in the wake of the controversy. The rate has since picked up again, but remains low in some areas of the country, most notably London. The number of measles cases has risen from 4,204 in 2003 to 56,390 in 2005.
The Independent reports that Dr Wakefield will face four charges: that he published inadequately founded research, failed to obtain ethical committee approval for the work, obtained funding for it improperly, and subjected children to "unnecessary and invasive investigations."
The paper says that detailed charges are being formulated by the GMC's lawyers, and will be presented in the autumn, with a public hearing expected next year. If found guilty, Dr Wakefield could be struck off the medical register.
Dr Wakefield carried out his initial study while working at London's Royal Free Hospital.
He has since moved to the United States.
A General Medical Council spokesperson refused to confirm details, but said: "An investigation is ongoing."
She said the council had been investigating Dr Wakefield since The Lancet issued its retraction in 2004. She added that any charges against him might "evolve" before they were formally presented.
In 2004, it emerged that at the time he was preparing The Lancet paper, Dr Wakefield was being paid by lawyers for parents of children allegedly damaged by the MMR vaccine to look for evidence that could be used to help take legal action against manufacturers of the vaccine.
He received £55,000 from the Legal Aid Board, which was paid into his research fund but which he had not disclosed to his co-researchers. At least four of the 12 children in the Lancet study were also in the Legal Aid Board funded study. He was accused by The Lancet of failing to declare a conflict of interest that could have influenced his findings.
Richard Horton, the editor of The Lancet, declared the paper "fatally flawed" and said if he had known in 1998 about the conflict of interest he would never have published it. The journal partially withdrew the paper in February 2004 and the following month 10 of the 12 authors withdrew the claim of a link with autism.
John Reid, the British Health Secretary at the time, called on the GMC to hold an inquiry.
Dr Wakefield, a consultant gastroenterologist, left the Royal Free Hospital in 2001 "by mutual agreement". He has since worked mainly in America.
The Government's chief medical officer, Sir Liam Donaldson, accused Dr Wakefield of mixing "spin and science."
But Jackie Fletcher, of the British support group, Jabs, representing parents concerned about vaccination, said: "The GMC charges are totally unfounded and seem to be a total witch hunt against Andrew Wakefield and the research team. All the researchers did was raise a red flag [about MMR] and say more research was needed." All the doctors are believed to have denied professional misconduct.
At the press conference to launch the 1998 paper, Dr Wakefield had parted company with his colleagues to say that, in his opinion, single jabs might be safer than the three-in-one MMR combination. The take-up of MMR slumped and is still low in some parts, especially areas of London. Public health experts have warned that measles outbreaks are possible, in which some children may be damaged and even die. The numbers of cases of mumps has risen.
A top-level inquiry commissioned by the Medical Research Council examined Dr Wakefield's findings, and epidemiological studies were commissioned which found that children given the MMR vaccine were no more likely to become autistic than those who were not. The message from the medical establishment consistently said that there was no evidence of a problem with MMR.
However, Jackie Fletcher of Jabs said: "It's the GMC who are calling Dr Wakefield to answer charges, not the parents of children damaged by MMR who were involved in the studies. All of the parents support him and feel they were treated well. They have nothing but praise for him. The Department of Health continues to recommend the MMR, based on epidemiological data, gathered from GPs' records and hospital notes. It's a system that does not pick up and examine the 'rare' events, and it's estimated that only 10 per cent of adverse drug reactions are reported by doctors using current methods.
"We want the Health Minister to instigate a clinical study of the children claimed by parents to have been damaged."
The parents say new evidence is emerging of the continued presence of measles vaccine in the guts of sick children long after it should have been cleared from their bodies. They say that this, among other factors, merits a closer look.
In July 2000, an all-party parliamentary group led by Dr Elizabeth Miller, head of the immunisation division at the PHLS Communicable Disease Surveillance Centre, presented a review on the safety of the MMR vaccine. Its conclusions were that the vaccine was safe, and that alleged links with various conditions such as inflammatory bowel disease (IBD) and autism were unfounded.
In 2001, Dr Wakefield and the Royal Free Hospital parted company, apparently by mutual consent. He later said he had been asked to go "because my research results are unpopular," He is continuing his research in Texas.
He is still adamant that the scientific results of his 1998 research are valid. He said he welcomed the General Medical Council's decision to investigate how he conducted his research.
He has recently told friends that he "looked forward to the chance of a hearing at the GMC to air his views fully."
Last year, the Cochrane review published a report on MMR, pulling together all the available information on the jab from around the world. It reported that "all the major events, such as triggering Crohn's disease or autism, were suspected on the basis of unreliable evidence."
The lead author of the review, Dr Vitorio Demicheli said: "Public health decisions need to be made on the basis of sound evidence. If this principle had been applied in the case of the MMR dispute, then we would have avoided all the fuss."
The authors concluded that anyone arguing for or against a therapy need to make sure their conclusions were based on carefully collected evidence and "not just on biased opinion, speculation and suspicion."
A spokesman for the British government's Health Protection Agency said: "We back the MMR vaccine 1