FDA & Rezulin Involvement

The FDA has been under public scrutiny because of conduct issues. In a letter to the Department of Health and Human Services the Public Citizen group urged HHS leaders and all government agencies to re-read and strongly urge the implementation and enforcement of a 1958 Congressional Resolution entitled The Code of Ethics for Government Service that states “Any person in Government Service should put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department.” in addition to the section stating that government “employees shall disclose waste, fraud, abuse, and corruption to appropriate authorities.”

Rezulin was approved under conditions that many FDA physicians describe as lowered safety standards. During the course Rezulin was on the U.S. market the FDA strengthened the Rezulin labeling four times due to the continuation of liver failure deaths and injuries Rezulin was associated to, the first one occurring in November of 1997 until the Rezulin recall in 2000. Prosecutors that were assigned to the office of the U.S. attorney questioned FDA officials in July 2000. They explored the Warner-Lambert’s conduct, as well as the FDA’s conduct.

An FDA epidemiologist, Dr. David J. Graham, and an agency pharmacist, Lanh Green, presented a detailed analysis of Rezulin in March 1999 estimating that the drug had been linked to more than 400 liver failures. Only 1-10% of adverse drug reactions are thought reported to the FDA according to experts. Graham felt at that time that Rezulin was one of the most dangerous pills on the U.S. market despite the safety assurances from Warner-Lambert and the FDA. Liver failure was an unavoidable side effect of Rezulin according to Graham.

Dr. Sidney Wolfe, director of Public Citizen Health Research Group, finds that the FDA has a “dangerous pattern of approving drugs too readily and waiting too long to remove them. It makes some people lose faith in the FDA. It also winds up killing a lot of people that wouldn’t have been killed had the drugs not been put on the market in the first place,” (ABCNEWS.com, 3-29-00). The FDA’s own analysis of recent drug recalls that was published in 1999 in the Journal of the American Medical Association found that in a 3-4 year period more than 20 million people were exposed to unsafe drugs.

Warner-Lambert knew of the dangerous Rezulin side effects far before the FDA ordered the diabetes drug to be withdrawn.