Bayer AG may have known its withdrawn cholesterol-lowering drug Baycol caused a high rate of a serious muscle condition more than a year before it added a warning to its label, according to a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 authors argue that only a small fraction of adverse events from already approved drugs are actually reported, and cite an inherent conflict of interest in the process.

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 current approval process for drugs and biological agents in the United States has come under intense scrutiny, most notably because of concerns about influence from the industry," the authors noted.

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.

Additional information on the Baycol withdrawal sheds light on the problem, they said.

Baycol was withdrawn from the U.S. market in August 2001 after it was linked to more than 100 deaths. 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.

The editorial argued for the establishment of an independent drug safety board separate from the FDA to oversee postmarketing surveillance.

"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.

He said doctors and the public must recognize that regulatory approval does not guarantee safety and that postmarketing monitoring remains critical.

"There is no need for additional duplicative regulatory oversight of newly marketed drugs. Our FDA colleagues can be trusted to do the job, given sufficient resources," he said.

In a separate article, David Graham, the high-profile FDA reviewer who last week accused the agency of being incapable of protecting America from unsafe prescription drugs, said three of the most popular cholesterol-lowering medicines in the same statin class as Baycol pose a low risk of the toxic muscle breakdown disease called Rhabdomyolysis, according to a study.

The three were Pfizer Inc's Lipitor, Merck's Zocor and Bristol-Myers Squibb Co.s Pravachol.

The study found that combining the statins with medicines known as fibrates, which lower triglycerides, caused a 12-fold jump in risk versus statins alone. The drugs are often prescribed together.

The study found that patients with diabetes or kidney problems taking the combination had a high risk of developing Rhabdomyolysis.

The article did not mention AstraZeneca Plc's new statin Crestor, which Graham last week singled out as one of the drugs he believes to be dangerous.

"It would be wonderful to conduct a study similar to this" on Crestor, Graham said in an interview, "but the FDA has not identified a database big enough to accomplish that."

Reference Source 89
November 22, 2004

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