Monday, November 08, 2004

F.D.A. Drug Safety System Will Get Outside Review
New York Times article - "Amid intense criticism that it is slow to raise the alarm about unsafe medicines, the Food and Drug Administration announced Friday that it would hire the nation's top scientific review body to figure out whether the drug safety system is adequate. In another step, after embarrassing disclosures that the views of its own drug safety officials had been suppressed, the F.D.A. said it would set up an internal appeals process. If someone inside the agency feels that superiors have made a mistake by approving a drug or, after approval, refusing to order its recall, that person will be able to make a case before a committee of experts, from inside and outside the agency, who were not involved in the decision. ... A stinging editorial Friday in The Lancet, a British medical journal, condemned the F.D.A.'s entire system of drug safety review and said the agency had acted out of 'ruthless, shortsighted and irresponsible self-interest' in failing to demand the removal of Vioxx earlier." [Viewing New York Times resources requires registration, which is free]. See also Vioxx, the implosion of Merck, and aftershocks at the FDA in the Lancet, which also requires free registration.    
  

Revealed: secret plan to push pills (UK)
Story in the Guardian - "Britain's largest drug company drew up a secret plan to double sales of the controversial anti-depressant Seroxat by marketing it as a cure for a raft of less serious mental conditions, The Observer can reveal today. The contents of the 250-page document have alarmed health campaigners who accuse the firm, GlaxoSmithKline (GSK), of putting profit before the therapeutic needs of patients by attempting to broaden the market for the drug which has been linked to a spate of suicides. The revelation is likely to prompt further concerns about the role and influence of the pharmaceutical industry, which has come under severe scrutiny in recent months. The document is now being investigated by a parliamentary inquiry into the drugs industry. "