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News Posted by Sylvia on Friday, March 26, 2004 (10:01:11)

Scotsman News 15/03/2004

By Joe Churcher

An independent inquiry should be ordered into claims that controversial research that linked the MMR vaccine with autism involved “unethical” medical tests on young children, the Government was urged tonight.

Liberal Democrat Evan Harris (Oxford W and Abingdon) told the Commons the welfare of the young people at the centre of the tests “seems to have been forgotten” amid controversy over claims of financial conflicts of interest.

Evidence from an investigative journalist had raised “doubts and allegations about whether children were exposed to unacceptable risks and unnecessary procedures”, he said.

Dr Harris told the Commons: “There is very clear evidence pointing towards unethical conduct by the researchers, or one or some of them, and equally strong evidence of failure and incompetence by the Research Ethics Committee.”

Procedures carried out on the children included endoscopies and spinal taps, “not trivial procedures on consenting adults let alone autistic children who have to be heavily sedated or even anaesthetised”, he said.

He said ethical permission had been granted for the research on the basis that the trials would involve children with a particular “very rare” condition – disintegrative disorder – whereas in fact most had only autism.

“Without ethical approval the consent the doctors obtained from the parents may not be valid. Without a valid consent doctors can face the potential action for assault.”

Those parents had given their consent “in good faith” and many still supported the doctors, he said.

“Even valid parental consent does not make lawful the conduct of high-risk research procedures on children with no likely benefit.”

Dr Harris said the General Medical Council, the Government’s “favoured path” for investigating the claims, was powerless to investigate key aspects of the case.

“This could still be going on at the Royal Free or elsewhere. Children need protection from this sort of research behaviour.

“If the Government cannot guarantee that this is not still happening there or elsewhere it has no choice but to order an independent inquiry.”

Junior health minister Melanie Johnson, praising the “hammer blow” dealt to measles, mumps and rubella by the triple vaccine, said the editor of the medical journal which first published the research had conceded that an alleged conflict of interest meant it was “fatally flawed”.

She said ethical approval was an “essential element” of research involving children and involved striking a difficult balance.

Spinal taps were “undoubtedly unpleasant and not risk free” and colonoscopies were “unpleasant and distressing” and could lead to complications, she said.

She told the House the Government would have to await the GMC’s findings but could take further action.

“We are waiting for the outcome of the GMC’s deliberations and we want to see very carefully what the results of these are.”

“Should there be aspects of the case that would then require further scrutiny or investigation we will give them the most serious consideration and take action accordingly.”

She said she was sure the hospital would also be considering its response to the allegations.

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x x Posted by Sylvia on Friday, March 26, 2004 (10:01:11) (1227 reads) x x

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