Los Angeles — Warner-Lambert Co. downplayed liver damage concerns as it sought federal approval for its diabetes drug Rezulin, the Los Angeles Times reported Sunday.
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 It garnered $2.1 billion in sales before it was withdrawn last spring after being suspected of causing 391 deaths, including dozens involving liver damage.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.
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