WASHINGTON -- Saying that the issues "go to the heart of the public's confidence" in the Food and Drug Administration, three senior House Democrats are seeking answers to extensive questions about the agency's approval of the diabetes pill Rezulin.
In a four-page letter to Dr. Jane E. Henney, the newly installed FDA commissioner, Reps. John D. Dingell of Michigan, Sherrod Brown of Ohio and Henry A. Waxman of California said the agency's handling of the drug calls into question whether the public is being adequately protected.
The congressmen asked Henney to catalog the extent and dates of at least 33 Rezulin-related deaths and "cases of serious liver damage." They asked Henney why Dr. John L. Gueriguian, the FDA medical officer assigned to evaluate Rezulin's safety, was stripped of his assignment after raising safety concerns and recommending the agency reject the drug.
The congressmen told Henney their inquiries were prompted by disclosures in a Los Angeles Times series, published Dec. 6 and 7. The articles revealed that senior FDA officials dismissed explicit warnings of danger while racing to approve Rezulin, and that the government's top diabetes researcher entered a
consulting deal with the manufacturer of the drug while overseeing its inclusion in a $150 million federal study.
In their letter to Henney, the three congressmen posed questions that focus on the FDA's basis for keeping Rezulin on the market, despite liver-failure deaths that have mounted since regular monitoring of patients was recommended last year.
The letter, received by Henney yesterday, also asked, "What proportion of patients are complying with the liver function tests?"
To date, FDA officials and representatives of Warner-Lambert Co., the maker of the drug, have said in interviews that Rezulin is safe for the more than 1 million reported users when taken with liver-function monitoring.
Rezulin has been associated with the liver-failure deaths of at least 33 people in its first 21 months on the market in the United States and Japan. The pill is prescribed to patients with adult-onset diabetes to help lower their blood sugar.
Pub Date: 12/23/98