For Your Information(a)

March 15, 2004

For Your Information:-

Drug safety agency accused of cover-up Sarah Boseley, health editorSaturday March 13, 2004The Guardian The chief executive of Mind, the mental health charity, last night resigned from a high profile review of modern antidepressant drugs, accusing the British medicines regulatory body of negligence. Richard Brook had a unique position as a lay member of the expert working group on the class of antidepressants which includes Seroxat and Prozac. His resignation came in protest at what he considered a cover-up by the regulators, after months of pressure on him not to reveal the review's findings that Seroxat has for years been prescribed by doctors in an unsafe dose and that the regulators had the evidence in their possession for more than 10 years. Mr Brook's resignation sheds a rare light on the workings of the secretive drug regulation agency and its advisers, and will heighten public concern over their relationships with the pharmaceutical manufacturers. The expert group drew the attention of the government's advisory Committee on Safety of Medicines to the dosage issue in October. Mr Brook, who had been invited to represent patient interests because of concerns that the CSM is too close to the pharmaceutical industry, pressed for the findings on dosage to be put into the public domain. Mr Brook warned the CSM and the Medicines and Healthcare Products Regulatory Agency, which licenses drugs on the advice of the CSM, last week that he felt he had no choice but to go public because of the risks to patients.

He was warned in a letter last Monday from the MHRA that he could risk prosecution under the Medicines Act 1968, which protects the commercial confidentiality of information from drug trials. ------------------------

"A positive attitude may not solve all your problems, but it will annoy enough people to make it worth the effort."

Herm Albright1876-1944, Author