March 12, 2001-Company knew liver-damage risk of drug, documents suggest a government medical officer's critical memorandum was stifled
According to a report by the Los Angeles Times, Warner-Lambert Co. downplayed liver damage concerns as it sought federal approval for its diabetes drug Rezulin. Warner-Lambert assured the U.S. Food and Drug Administration that the drug's risk was low, while FDA officials gave the company inside information and favors at key points in the drug's development, the newspaper reported, citing previously unpublicized company and government documents.
The company knew at least 12 people had suffered potentially life-threatening liver damage during clinical trials. In December 1996, Warner-Lambert's vice president for diabetes research, Dr. Randall W. Whitcomb, told the Endocrine and Metabolic Drugs Advisory Committee of the FDA that incidences of damage were "comparable to placebo" in the studies, the Times said.
In fact, 2.2 percent of the patients who took the drug had suffered liver problems, compared to 0.6 percent who took the ineffective placebo pills. "I don't think that these numbers are, are all that different," Whitcomb said in a recent deposition for several lawsuits brought against the company. The FDA approved the drug in January 1997. It garnered $ 2.1 billion in sales before it was withdrawn last spring after being suspected of causing 391 deaths, including dozens involving liver damage.
A message left at New York-based Pfizer Inc., which acquired Warner-Lambert last year, was not immediately returned. FDA spokesman Lawrence Backorik said Sunday that he was "not in a position to comment on allegations concerning the conduct of the company or former FDA employees that were involved in the review of troglitizone." Troglitizone is the generic name for Rezulin. "The FDA bases its actions on science." Backorik said. "When, in our view, the risk of approved products outweighs the benefits, FDA sees that the product is withdrawn."
The Times, citing Warner-Lambert e-mails and memos, said the company knew as early as 1993 of at least one case of a patient who showed liver damage after taking Rezulin. Last year, a consultant to Warner-Lambert who helped conduct two of its studies alleged that the firm "deliberately omitted reports of liver toxicity and misrepresented serious adverse events experienced by patients in their clinical studies." The remarks by Dr. Janet B. McGill, a St. Louis endocrinologist, were made in a letter to Sen. Edward Kennedy, D-Mass.
Dr. John Gueriguian, an FDA medical officer assigned to examine Rezulin, told the company as early as 1994 that he was concerned about "potential toxicities." But Gueriguian's boss, Dr. G. Alexander Fleming, told a Warner-Lambert executive in 1995 that "he would ease Dr. Gueriguian out" if the executive was displeased with him, according to a memorandum from the executive.
Gueriguian was removed from the case in 1996. Fleming e-mailed a copy of Gueriguian's unflattering medical review to the company, but it was withheld from the advisory committee that examined the drug, the newspaper said.
Two days before the advisory committee meeting, Fleming e-mailed Warner-Lambert's executive vice president for regulatory affairs, Irwin G. Martin, saying "the drug looks like it ought to be on the market. Loosen up and put on a good presentation. Call if you need help."
The Times said the company also received behind-the-scenes help from Dr. Murray M. "Mac" Lumpkin, who now is being considered for appointment as FDA commissioner, and Dr. Henry G. Bone III of Detroit, chairman of the advisory committee. Pfizer Inc. said last fall that it was defending against 383 Rezulin-related lawsuits in federal and state courts.
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