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No Whitewash on drug trial probe

March 2006

No Whitewash on drugs trial probe.
“The regulators must not be allowed to investigate themselves”
19/3/06


Paul Flynn MP (Newport West) who last week criticised the UK drug regulatory body the MHRA as ‘weak’ called on the Government to oversee the investigation into the TGN1412 drugs trials. We now know that the MHRA failed to consult on a similar “monoclonal antibody” which had caused severe toxic reactions in patients.

The Sunday Times reports today that “Angus Dalgleish, a world expert on immunology, said yesterday that he was amazed the trial had been allowed to proceed. “The previous studies which caused similar severe side effects were in patients already suffering from cancer, but [the researchers] should have known they would get a meltdown because this drug was hitting exactly the same immune response pathways,” said Dalgleish, a professor of cancer at St George’s hospital medical school, south London. “

Paul Flynn said the Medicines and Healthcare Products Regulatory Agency (MHRA) has a poor record in failing to detect the severe adverse side effect of both Vioxx and Seroxat. The side effects of 144,000 heart attacks and strokes as result of taking Vioxx were detected in the United States. Our ramshackle MHRA system detected only a handful of adverse effects. The MHRA investigation into the suicidality caused by the antidepressant Seroxat was delayed because the majority of the investigating committee had interests in the pharmaceutical industry.

It appears to be an act of lamentable lack of care to give a drug, never before ingested by human beings, to six people simultaneously. We need a comprehensive, rigourous, genuinely independent inquiry. We cannot allow the regulators to investigate the regulators - especially when the MHRA is over represented by the pharmaceutical company interests. There must be no whitewash.


Paul Flynn is vice-Chairman of the Council of Europe Health Committee.

Dalgleish said an engineered antibody, developed by a team led by Steven Rosenberg at America’s National Cancer Institute, and using the same pathway as had produced severe side effects in about half of a group of patients dying of cancer.