Inquiry after 'flawed' autism study

Published on Sunday 22 February 2004 00:00

HEALTH Secretary Dr John Reid last night backed calls for an inquiry into claims that controversial research linking the MMR vaccine to autism should never have been published.

He urged the General Medical Council to mount an investigation "as a matter of urgency" after medical journal the Lancet said it should never have published the findings.

That followed the disclosure that Dr Andrew Wakefield, who carried out the research, had also been working on a study to see if there was evidence to support a legal action by parents claiming the MMR jab had harmed their children.

The Lancet editor, Dr Richard Horton, said that represented a "fatal conflict of interest" and that he now regarded Wakefield’s research as "entirely flawed".

However campaigners against the MMR triple vaccine, which protects against measles, mumps and rubella, claimed Wakefield was being smeared.

In a statement, Reid said: "This alleged conflict of interest is a matter for the GMC. I am sure they will want to look into this as a matter of urgency."

The GMC said it was "concerned" by the allegations and would be investigating whether or not it needed to take action.

Millions of parents have spent the last six years agonising over whether to let their children have the MMR jab following the findings by Wakefield and colleagues at London’s Royal Free Hospital.

The study raised such widespread alarm that a significant number of parents refused to have their children vaccinated with MMR, increasing the risk of an increase or even an epidemic of one or more of the diseases.

The increased incidence of measles has been blamed on the study.

In 1997-98, 90.8% of children under two were immunised with MMR, but by 2001-02 that level had dropped to 84.1%.

Horton said: "If we knew then what we know now, we certainly would not have published the part of the paper that related to MMR. I do believe there was, and remains, validity to the connection between bowel disease and autism, which does need further investigation, but I believe the MMR element of that is invalid."

He said that he regarded the section of Dr Wakefield’s research relating to MMR as "entirely flawed" and that he believed the MMR jab was "absolutely safe".

Liberal Democrat MP Dr Evan Harris, a member of the House of Commons’ science and technology select committee, said: "What the Lancet has found is a serious matter of non-disclosure and conflict of interest, which has an impact on the credibility and validity of the interpretation of the research findings.

"Given the importance attached to the work of the Royal Free Hospital group by the media in the MMR debate, an inquiry is needed to establish what actually happened during this study and related studies, and how Legal Aid Board funding was spent."

He added: "The Lancet and Royal Free have investigated themselves, and parents worried about MMR will need a fully independent inquiry."

Dr John Garner, chairman of the British Medical Association in Scotland, which has consistently supported use of the MMR vaccine, said: "We don’t know the full story but we are obviously concerned that the conflict of interest was not declared when Dr Wakefield submitted his paper."

It was claimed that Wakefield received 55,000 from the Legal Aid Board to conduct the pilot project and that, since there was a substantial overlap of children in both studies, this was a financial conflict of interest which should have been declared to the Lancet editors and his co-authors.

The editors said Wakefield had two roles in this work. "First, he was the lead investigator of a Royal Free study into the nature of a new syndrome with bowel and psychiatric symptoms. Second, he was commissioned through a lawyer to undertake virological investigations as part of a study funded by the Legal Aid Board.

"At the time of submission and eventual publication of his 1998 Lancet paper, this second study had not been disclosed to the editors of the Lancet and his co-authors."

They said "the perception of a potential conflict of interest remains", adding: "This funding source should, we judge, have been disclosed to the editors of the journal."

Wakefield said in a statement to the editors: "The clinical and pathological findings in these children stand as reported."

Wakefield said the children were referred according to clinical need. He added: "Funds received from the Legal Aid Board were paid into, and properly administered through, a research account with the special trustees of the Royal Free Hampstead NHS Trust."

The hospitals told the editors they were "entirely satisfied" the investigations performed on the children and reported in the Lancet paper had been "subjected to appropriate and rigorous ethical scrutiny".