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| Heads Roll at the FDA
by John M. Curtis Copyright October 19, 2000
Research sponsored by Warner-Lambert and published in the prestigious New England Journal of Medicine curiously found no such complications. One year after Rezulin’s release, Warner-Lambert exceeded 2 billion dollars in annual sales, exposing their fierce opposition to seeing their darling banned from the market. Drug maker’s motives are fairly conspicuous, but irregularities inside FDA’s acclaimed drug review center is now under investigation by the U.S. Attorney’s office in Greenbelt, Md. With liability suits now proliferating, questions remain unanswered as to why the FDA’s touted Drug Review Unit ignored the best evidence and fought taking Rezulin off the market. When the Los Angeles and New York Times found a golden trail from drug makers to university research departments and then to respected medical journals, eyebrows were raised. Some cynics are now wondering whether the same golden trail led to the inner sanctum of the FDA. Under pressure from the drug maker Warner-Lambert, Lumpkin even ordered Gueriguian’s unfavorable report purged from the FDA’s files. Eight months after banning Rezulin, Woodcock informed her staff via e-mail that the 46-year old Lumpkin resigned "for personal reasons," after serving for 7 years as Woodcock’s No. 2 chief. Sounding Orwellian, Woodcock praised Lumpkin for his years of dedicated service. "Mac has played a huge role in the center’s performance improvements," touting the efficiency with which he obtained "fast-track" approval for many new drugs. While Lumpkin’s taking the fall, the record clearly shows it was Woodcock who vehemently opposed taking Rezulin off the market. Even earlier this year, Woodcock strongly insisted, "In many patients it [Rezulin] has proven to be very effective." As the undeniable evidence and objections mounted within the FDA, Woodcock said, "People who felt that the drug was too risky shouldn’t have prescribed it." Only after the drug was banned on March 21, 2000 did Dr. Woodcock finally change her tune, "We are now confident that patients have safer alternatives." Banned in Great Britain in December 1997, only one month prior to its American debut, Rezulin was already known for its dangerous liver toxicity in the U.S. and Japan. "The drug’s risks outweigh its benefits," said the British Medical Control Agency, "We do not have any recent data regarding additional benefits . . . nothing that isn’t already there with other drugs," directly contradicting Woodcock’s statement on March 21, 2000 that "We are now confident that patients have safer alternatives." As British authorities indicated in 1998, at least 10 safer alternative drugs existed, lending no scientific justification for keeping Rezulin on the market. When FDA’s new chief Dr. Jan E. Henney ordered her top researcher on adverse drug reactions Dr. David J. Graham to urgently evaluate Rezulin in 1999, Dr. Woodcock dismissed Graham’s finding for 'over-reaching' and muzzled him from publicly divulging his report. Despite Graham’s urgent findings, Woodcock’s committee voted 11-1 to keep Rezulin on the market. Sacrificing the No. 2 man in the FDA’s powerful Drug Review Committee, Dr. Murray "Mac" Lumpkin, doesn’t begin to deal with the 'internal' reasons why Rezulin remained on the U.S. market nearly 3 years after it was banned by British authorities. With all the emphasis on safety and effectiveness, the FDA is hard pressed to explain how a lethal glitch wound up killing and maiming countless consumers who are totally dependent on the FDA’s disclosures of dangerous side effects on its approved medications. Woodcock’s reluctant capitulation suggests a vested interest in keeping a dangerous drug on the market. Posting warning labels only delayed the inevitable and kept well-intentioned physicians in the dark while they inadvertently harmed and killed hapless patients. While the FDA attributes the Rezulin debacle to a bureaucratic aberration, the fact that Lumpkin got the ax and others still remain tongue-tied suggests a systemic problem. Known in law enforcement, a code of silence perpetuates corruption by punishing whistle blowers. When America’s health is at stake, no bureaucratic code of silence or internal coercion can be tolerated. Calling the shots, publicly traded drug makers now have their 'golden' tentacles in university research departments, vaunted medical journals, and sacrosanct federal agencies like the FDA. America can’t tolerate abysmal mediocrity in its health care system, and certainly not corruption in the FDA on which doctors and patients depend for sound scientific advice. Department heads, not underlings, must take the heat for acting in self-serving ways and failing to protect the public good. Looking at the record, Dr. Lumpkin took instructions from his boss, not, as Woodcock suggests, over her objections. Like rogue police departments, federal agencies must also be purged of corrupt bureaucrats lining their pockets and endangering consumers. Enough drug companies supply the FDA with questionable research on their product’s safety and effectiveness. Federal agencies or administrators shouldn’t muddy the waters by getting into bed with multinational companies pushing, at all costs, to get their products on the market. With America’s health and the FDA’s credibility on the line, it’s no longer time for more excuses. Upper management must face the diagnosis, accept the cure, and swallow hard. About the Author John M. Curtis is editor of OnlineColumnist.com. He’s also the director of a West Los Angeles think tank specializing in human behavior, health care and political research and media consultation. He’s a seminar trainer, columnist and author of Dodging The Bullet and Operation Charisma. |
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aking out the meat cleaver, Dr. Janet Woodcock [head of the FDA’s prestigious Drug Approval Unit] finally beheaded her chief lieutenant Dr. Murray "Mac" Lumpkin for his role in the FDA’s Rezulin PR train wreck. Originally approved under the FDA’s "fast-track" program in 1997, Rezulin—the highly touted 'miracle drug' for diabetes—was responsible for more than 100 deaths, 400 cases of liver failure and countless complications. Approved by Lumpkin over the objections of Dr. John L. Gueriguian in 1996, whose own internal FDA research indicated that Rezulin had dangerous liver toxicity, Lumpkin demoted Gueriguian, stripped him of his involvement with Rezulin, and proceeded to blindly get the drug to market. Blaming Lumpkin and believing that he acted over the objections of his boss defies all common sense. Now incommunicado, the otherwise garrulous Lumpkin remains speechless.|
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