The US Food and Drug Administration (FDA) plans to tighten drug safety following allegations that two withdrawn drugs - Merck's arthritis drug Vioxx and Bayer's cholesterol reducing drug Baycol - could have been withdrawn sooner.
The US Food and Drug Administration (FDA) plans to tighten drug safety following allegations that two withdrawn drugs - Merck’s arthritis drug Vioxx and Bayer’s cholesterol reducing drug Baycol - could have been withdrawn sooner.
Acting commissioner Lester Crawford says the FDA will sponsor a major study of the Drug Safety System by the Institute of Medicine and appoint a permanent director for the Office of Drug Safety. It will also conduct workshops and meetings on drug safety and risk management and publish risk management guidance. The new programme will allow for peer review by an ad hoc panel, the FDA and outside experts to avoid scientific disagreements leading to increased public risk.
Under the spotlight over its approval and post-marketing surveillance of Vioxx, linked to increased risks of heart attack and strokes, the FDA’s role in the August 2001 Baycol recall is also facing scrutiny. The December 2004 issue of the Journal of the American Medical Association (JAMA) provides fresh insight into Baycol, linked to at least 31 patient deaths from the muscle-wasting disease rhabdomyolysis.
Leaked Merck documents and e-mails suggest that the company knew about Vioxx’s dangerous side effects as far back as 2000, although it was not pulled from the market until September 2004.
Similarly, University of Washington professor of medicine and epidemiology Bruce Psaty and colleagues have reviewed published literature and internal Bayer documents. They found that Bayer knew of the link between Baycol - taken with another cholesterol-lowering drug called gemfibrozil - and rhabdomyolysis months after the drug’s launch in February 1998. Bayer appears not to have informed patients or physicians for over 18 months.
Psaty concludes that Bayer scientists knew that, even taken alone, Baycol was more likely to cause rhabdomyolysis than other, competing drugs - a situation the FDA should have immediately been informed of. If the FDA can find data to support these allegations, then Bayer could be subject to a criminal investigation.
Bayer replies that the original Baycol labelling warned of rhabdomyolysis, and that the FDA audited the company’s post-marketing reporting and was satisfied. The company also confirms that it amended its labelling, specifically contraindicating the use of Baycol with gemfibrozil in December 1999. It states that its conduct was ’responsible, appropriate, and constantly motivated by concern about the safety and welfare of patients’.
Psaty and colleagues write that ’defects in the safety-surveillance system can, depending in part on the response of the pharmaceutical company, pose a threat to the health of the public’. Their findings highlight the limitations of post-marketing drug safety surveillance in the US, where drugs are often marketed first, putting the onus on authorities to detect safety issues early.