REZULIN: FDA Panel Adds Two Researchers Linked to Drug Co.
On the eve of an FDA panel meeting to review evidence that Warner-Lambert's diabetes drug Rezulin may cause liver failure, two diabetes researchers who have been on the drugmaker's payroll were added to the panel in "11th-hour appointments," the Los Angeles Times reports. Dr. Mayer Davidson of the University of California-Los Angeles School of Medicine and Dr. Saul Genuth of Cleveland were appointed without public notice despite having received about $17,000 each over the last two years for serving as "faculty" members onWarner-Lambert's National Diabetes Education Initiative, a panel of doctors that recommended the drug. Kathleen Reedy, executive secretary of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, said both appointments "were made with the consent of senior agency officials," bringing total membership on the committee to 13. The Times reports that Davidson's ties to the drugmaker were known by the agency. "I gave all this information to the FDA so I have to leave it up to them as to whether they felt there would be a conflict of interest," he said. The FDA is allowed to appoint committee members with conflicts of interest as long as "the conflict is outweighed by the expertise to be gained."
At tomorrow's meeting, the committee will decide whether liver function tests are protecting Rezulin patients and whether the drug is safe enough to be used as a "stand-alone diabetes pill." Public Citizen's Dr. Sidney Wolfe, a fierce critic of the drug, will be allowed ten minutes to speak (Willman, 3/25). "The drug is not on the market in Europe, and it's not that we're right and everybody else is wrong. ... This drug is just too dangerous," he said. But Andrew Drexler, director of the Mount Sinai Diabetes Center, said "the number of people who have died on other diabetes drugs should be considered 'to balance the relative safety of this drug. There is no drug on the market that is 100% safe'" (Davis, USA Today, 3/25). Warner-Lambert spokesperson Carol Goodrich said, "We are confident that the scientific data ... will reconfirm our belief that the benefits of this drug far outweigh the risks." The Bergen Record reports that "Rezulin's prospects have been dimmed by the FDA's review, the emergence of competing medications and the problems the drugs have had gaining approval internationally."
A Los Angeles Times editorial urges Congress to "take the lead in fixing the regulatory loopholes that are largely to blame for the Rezulin deaths." The Times states that "there are no federal laws requiring hospitals or other health care providers to report suspected adverse drug reactions to the FDA or even to the drug manufactures once a drug is approved for marketing." The editorial argues that if Congress does act, the FDA would need "more staff to enforce after-market drug surveillance." The Times concludes that "Congress can help some by approving the FDA's modest $15.3 million proposal to increase drug monitoring. But the agency must also respond by allowing more public scrutiny of how it looks after public safety" (3/25).