Originally published November 26 2004
Bayer accused of withholding evidence, delaying Baycol cholesterol drug warnings
by Mike Adams, the Health Ranger, NaturalNews Editor
Bayer, the manufacturer of Baycol, a cholesterol drug that was linked to over 100 deaths and pulled from the market in 2001, may have had advance knowledge for a year that the drug could lead to a serious muscular condition. The recent release of internal documents has shown that researchers at Bayer were aware that the risks associated with Baycol were present before they released the drug to the public and before they amended the warning label. This announcement comes on the heels of the Vioxx recall where the FDA has come under sharp criticism for failing to protect the public from dangerous prescription drugs.
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Bayer AG may have known its withdrawn cholesterol-lowering drug Baycol caused a high rate of a serious muscle condition more than a year before it added a warning to its label, according to a prominent medical journal.
- An editorial in the Journal of the American Medical Association is one of several articles to appear in next week's edition focusing on drug safety and the ability of the U.S. Food and Drug Administration to monitor it effectively.
- The articles were released early amid a rising furor over the recent withdrawal of Merck & Co.'s arthritis drug Vioxx and subsequent questioning by critics of the U.S. Food and Drug Administration's rigor in assessing Vioxx's safety.
- The editorial suggests there is a critical inadequacy in the system of monitoring drug safety as it falls to the drug companies themselves to collect, evaluate and report data from postmarketing studies of their own products.
- A review of published information and data obtained from internal company documents, which the authors saw while serving as experts for defendants in Baycol law suits, showed the company knew of the drug's risks earlier than stated.
- Bayer said in response that it closely watched the safety of Baycol after its approval and amended the drug's label as evidence of adverse reactions became apparent.
- "It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong," the authors said.
- However, Brian Strom, who has been a member of the FDA drug safety and risk management advisory committee, in a separate article argued that the system worked in the case of Baycol despite the obvious conflict of interest.
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