FDA: Key Backer of Fast-Track Rezulin Approval Resigns
Dr. Murray Lumpkin, a senior FDA official who played a "pivotal" role in the agency's "controversial" decision to approve Warner- Lambert Co.'s diabetes drug Rezulin, has resigned, according to an internal FDA email sent last Friday, the Los Angeles Times reports. Dr. Janet Woodcock, director of the FDA's drug review center, announced in an email to colleagues that Lumpkin resigned for "personal reasons" after serving as the center's second-in-command for seven years. While Lumpkin will remain "on the payroll" for several weeks and consider his options, he will serve in a "lesser position" with "no supervisory authority," according to the email. Lumpkin declined to comment about his resignation. In addition, FDA spokesperson Lawrence Bachorik said that he "did not know" the reasons behind Lumpkin's departure or whether Lumpkin would return to the pharmaceutical industry, where he served as director of international research at Abbott Laboratories before moving to the FDA in 1989.
In her email, Woodcock praised Lumpkin for "speeding" the FDA's drug approval process for newly proposed pharmaceuticals, such as Rezulin. Between late 1996 and 1997, Lumpkin directed the FDA's "fast-track" approval of Rezulin, despite objections from Dr. John Gueriguian, who warned about the drug's potential harmful effects on the liver and heart. Lumpkin "directed" FDA officials to "strip" Gueriguian of "further involvement" with Rezulin and then directed them to "purge" his review from FDA files, an "unusual" move, the Times reports. Even after Great Britain "banished" Rezulin in December 1997 because of reported liver failures in the United States and Japan, Lumpkin backed Warner-Lambert's efforts to keep the drug on the U.S. market. FDA epidemiologist Dr. David Graham warned in early 1999 that more than 400 Rezulin patients had suffered liver failure, calling Rezulin one of the "most dangerous drugs" on the market, but Lumpkin still "resisted" efforts by FDA doctors to withdraw the drug. In addition, during the final meeting of senior FDA officials in March, when the FDA decided to pull Rezulin from the market, Lumpkin still "argued for the drug" (Willman, Los Angeles Times, 10/19).