ANDREW WAKEFIELD, the scientist who triggered the scare over the MMR vaccine, has been accused in the House of Commons of unethical conduct during his pivotal study.

The controversial scientist’s team never received the correct ethical approval to perform invasive spinal taps on the autistic children in his care, according to Evan Harris, the Liberal Democrat MP.

Dr Harris, and former health spokesman who sits on the British Medical Association’s medical ethics committee, told the Commons during a debate that the design of the study eventually published in The Lancet in 1998 had been altered after it was authorised by the Royal Free Hospital’s ethics panel.

He said Dr Wakefield, who has also been accused of failing to declare a conflict of interest raised by a £55,000 payment, did not clear the changes with the ethics committee.

Dr Harris said this called the ethical justification of the work into question, and suggested that autistic children were subjected to risky and unnecessary lumbar punctures — in which spinal fluid is removed with a needle while the child is under sedation.

In the debate on Monday night Dr Harris said the Royal Free’s ethics committee may also be guilty of “failure and incompetence”, as it appeared not to have consulted an independent outside expert before approving the research.

The Lancet has cleared the researchers of failing to obtain proper ethical approval. However, it said last month that it would not have published the 1998 paper in the form it did, had it known that the lead author had been paid £55,000 as part of a legal action against the MMR vaccine’s manufacturers.

Dr Harris said the ethics allegations were more serious, and called on the Government to announce an independent inquiry to investigate them.

He said: “I do not make these allegations lightly . . . but there is very clear evidence pointing towards unethical conduct by the researchers — or by one or some of them — and equally strong evidence of failure and incompetence by the research ethics committee.” He said Dr Wakefield’s receipt of the payment did not appear to have been declared to the ethics committee, which could invalidate the approval he received for the original study protocol.

Documents also show that the original protocol suggested that the team would investigate children with disintegrative disorder, an extreme, late-onset form of autism known as DD. As lumbar punctures would normally be conducted on these patients, there were good grounds for authorising the study.

In the event, only one of the 12 children studied had a possible diagnosis of DD. The others were diagnosed with other conditions, none of which would normally provide grounds for a spinal tap.

The Royal Free Hospital said last night: “We are considering the points made by Evan Harris.”

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