Vioxx recall handling calls for reforms at FDA

University of Washington researchers, in a review article published in the Dec. 1 edition of the Journal of the American Medical Association, argue that an independent group, perhaps appointed by Congress, should be charged with determining when a medication should be withdrawn from the market. Dr. Bruce Psaty, professor of medicine and epidemiology, and colleagues say that when interpreting reports of suspected adverse drug reactions, pharmaceutical companies may have too high a threshold for taking actions in a timely fashion that protect the health and safety of patients. (Related article: FDA's political approach in handling Vioxx recall may have hurt Americans)

Some patients suffered adverse outcomes after taking cerivastatin, sold under the brand name Baycol, alone or in combination with another drug for the purpose of reducing blood cholesterol levels. Those adverse outcomes included rhabdomyolysis, a potentially deadly breakdown of muscle tissue that dumps toxins into the bloodstream. Psaty and his co-authors, Dr. Noel Weiss, professor in the UW School of Public Health and Community Medicine and member of the Fred Hutchinson Cancer Research Center, Dr. Curt Furberg at Wake Forest University Baptist Medical Center and Dr. Wayne Ray at Vanderbilt University, examined documents regarding cerivastatin research after they were recruited to serve as expert witnesses in a series of litigations brought by patients or their families. The JAMA article was written independently of any litigation.

“Some of the cerivastatin studies conducted by Bayer, which showed frequent adverse drug reactions, were not published by the company, but became public during a trial in Texas,” Psaty said.

“In effect,” noted Furberg, professor of public health sciences at Wake Forest, “what happens is that some companies may treat scientific data as if it is a marketing problem.”

Ray, professor of preventive medicine and director of the division of pharmacoepidemiology at Vanderbilt, added, “The cerivastatin affair, and more recently, the similar failure to promptly restrict rofecoxib (Vioxx) use when major doubts were raised about its safety, demonstrate that the drug regulatory system in the U.S. is not doing a good job of protecting patients' health and needs a major overhaul.”

Psaty added that the failure to publish the results of all scientific studies makes it impossible for patients and physicians to make truly informed decisions about the risks and benefits of a therapy.

“In the case of cerivastatin, the drug became available by prescription in early 1998,” Psaty said. “By May of that year, there was certainly evidence that there was a problem when it was co-prescribed with gemfibrozil. The company did analyses that suggested that even the use of cerivastatin alone was associated with a high risk of rhabdomolysis, yet the drug stayed on the market for three years.”

Psaty went on, “The question is, who should decide when a drug is removed from the market? The company has perhaps an impossible conflict of interest in interpreting adverse event reports. Leaving these decisions to pharmaceutical companies may subject the public to the adverse effects of medications, if decisions are made too slowly.”

As of Sept. 2004, Bayer AG had agreed to settle 2,861 cerivastatin lawsuits out of court. Litigation continues in other cases related to cerivastatin and rhabdomyolysis or myopathy.

Psaty testified regarding similar post-market adverse outcomes of the recently withdrawn pain medication Vioxx before a U.S. Senate committee Thursday in Washington, D.C. He and his colleagues testified that the manufacturer of Vioxx and the Food and Drug Administration should have been more attentive to problems that were noted in Vioxx studies as far back as the 1990s. (Related article: Vioxx recall hearings by the Senate Finance Committee produce no surprises)

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