JAMA editorial says FDA cannot be trusted to police itself

There is also increasing concern that doctors are not being given enough documentation by the FDA and drug companies describing the dangers of these medications before prescribing them to patients.

• The Journal of the American Medical Association, citing the slow pace of drug recalls after evidence turns up lethal side effects, called Monday for the creation of an independent agency to monitor the safety of pharmaceuticals once they come to market.
• The call for more nimble "post-marketing" surveillance was prompted by a spate of recent drug failures such as the arthritis pill Vioxx and cholesterol- lowering Baycol, both of which were pulled off the market long after studies showed they could be dangerous.
• In a sternly worded editorial released in advance of its Dec. 1 publication, the prestigious medical journal suggested that inherent conflicts of interest among industry researchers had led to suppression of study findings that were unfavorable to the companies for whom they worked.
• The editors also faulted the U.S. Food and Drug Administration for lackluster response to reports of adverse side effects in newly approved medications and concluded that only a separate agency could be trusted to monitor safety once drugs cleared the FDA.
• A professor of medicine at UCSF, Rennie said in an interview that the FDA itself has become a tool of the pharmaceutical industry it is supposed to regulate.
• The Journal editors trace the problem, as they see it, to the adoption in 1992 of the Prescription Drug User Fee Act.
• It was designed to speed up the agonizingly slow process of approving drugs by expanding the FDA's staff, drawing on drug company application fees to pay for it.
• The Journal editors supported their case with a series of articles discussing the August 2001 withdrawal of Baycol, a cholesterol-lowering statin that was introduced by Bayer in February 1998.
• His study released by the Journal analyzed the link between Baycol and the muscle-wasting disease rhabdomyolysis that led to the pill's withdrawal from the market in 2001.