Rezulin

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Summary

In 1996, the National Institutes of Health (NIH) began the Diabetes Prevention Program (DPP), which it described as "the first nationwide research study to determine whether Type 2 diabetes can be prevented or delayed in people likely to develop the disease." Once enrolled in the study, healthy volunteers with high blood sugar levels were given either one of two drugs, Rezulin or Glucophage, or a placebo, or undertook prescribed lifestyle changes.

One of the DPP study participants taking Rezulin, Audrey Jones, experienced sudden liver failure and died on May 17, 1998. In June 1998, the NIH decided to remove Rezulin from the DPP study. Since the DPP study has been underway, the Food and Drug Administration (FDA) has learned of 33 deaths and more than 738 cases of adverse reactions, including liver failure and serious liver damage, associated with Rezulin since its January 1997 approval. The FDA has revised Rezulin's labeling three times, with each revision calling for increasingly frequent tests to monitor whether the drug is damaging to the liver. On February 5, 1999, the FDA released new findings on Rezulin´s safety in a letter to Rep. Waxman.

According to an article in the Los Angeles Times, as key decisions were made at NIH about Rezulin and its use, Dr. Richard Eastman, one of the NIH researchers working on the Diabetes Prevention Program study, served as paid faculty of Warner-Lambert's "Rezulin National Speakers Bureau" and as an advisor to Warner-Lambert in its efforts to obtain Food and Drug Administration (FDA) approval of Rezulin.

Congressman Waxman sent a letter to NIH Director Harold Varmus with questions about the potential conflicts of interest raised by the relationship of Warner-Lambert and Dr. Eastman. Dr. Varmus has begun to investigate the matter, issuing a preliminary response followed by a preliminary report on the outside activities of senior NIH officials involved in the review and award of grants and contracts. The Los Angeles Times has followed the investigation, finding evidence of more questionable payments.

The FDA has responded to a letter that Congress Waxman sent to inquire about the continuing safety of Rezulin.

Please review my letters on Rezulin, the Los Angeles Times articles that broke and followed the story of Rezulin´s dangers and the potential conflict of interest, and links to other Rezulin resources.