Partners In Crime

Information published by the Los Angeles Times disclosed that a Bush Administration candidate for FDA Commissioner, Dr. Murray M. Lumpkin, provided assistance to Warner-Lambert Pharmaceuticals in its cover-up of potentially dangerous reactions to the drug Rezulin. At the time, Lumpkin was an executive with the Food and Drug Administration.

According to published reports the head of the advisory committee that was responsible for recommending the drug for release to the public, Dr. . Henry G. Bone III, also was involved in providing assistance to the company, as well. The report alleges that FDA officials replaced employees who did not agree with the release of the drug and implies that they knew of information in the possession of Warner-Lambert officials that was not presented in the hearings prior to release.

According to the report, Dr. G. Alexander Fleming, told company officials that he would ease out Dr. John Gueriguian, an FDA medical officer, after he advised the company as early as 1994 that Rezulin carried a potential liver toxicity risk to a small number of patients. Later Dr. Gueriguian was replaced and a copy of his report was sent to company officials. This report was never brought forward in the hearings, according to the Associated Press report.

In a Los Angeles Times expose, the FDA has acted as the "partner" of the pharmaceutical industry, and as a result has released products on the market which were later withdrawn because of safety issues. This attitude is not a one time occurrence, but has become the rule rather than the exception. As Dr. William Isley, a physician in Kansas City who was instrumental in the recall of Rezulin stated, "FDA used to serve a purpose... A doctor could feel sure that a drug he was prescribing was as safe as possible. Now you wonder what kind of evaluation has been done, and what's been swept under the rug."

Unnamed FDA officials concur that the pressures to approve medications for release are tremendous. "People are aware that turning something down is going to cause problems with [officials] higher up in FDA, maybe more problems than it's worth. Before I came to the FDA I guess I always assumed things were done properly. I've lost a lot of faith in taking a prescription medicine." Dr. John L. Gueriguian, the physician involved in the Rezulin recall described above stated, "Either you play games or you're going to be put off limits ... a pariah. The people in charge don't say, 'Should we approve this drug?' They say instead, 'Hey, how can we get this drug approved?'"

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