Rezulin for Diabetes

Two Times articles (Dec. 6, 7) and an editorial (Dec. 13) contain several half-truths and misstatements regarding Warner-Lambert’s therapy for Type 2 diabetes, Rezulin, and the company’s interactions with the U.S. Food and Drug Administration and the National Institutes of Health.

Rezulin offers unique and substantial benefits for the treatment of Type 2 diabetes and has been used safely in more than 1 million patients. To suggest that the drug is unsafe is a disservice to Type 2 diabetes patients--and simply wrong. It is irresponsible to evaluate Rezulin solely in the context of anecdotal case reports. A fair and balanced evaluation requires a benefit-risk assessment. The FDA has made that evaluation and determined Rezulin’s benefits outweigh possible associated risks.

Warner-Lambert has always provided all Rezulin clinical safety and liver-related data to the FDA. Since the first revisions to the label for Rezulin in 1997 that recommended periodic monitoring of liver function, the rate of serious liver-related adverse events has fallen substantially.

Warner-Lambert’s comments regarding the death of a patient in the NIH’s diabetes prevention program were accurate and supported by expert reports. The independent NIH panel report did not conclude that troglitazone (Rezulin) caused the patient’s death. In fact, the expert panel did not even recommend that troglitazone be withdrawn from the study. The experts’ report noted that the patient who died had significant other medical problems unrelated to the drug.

When it comes to public health issues, Warner-Lambert, health authorities and the media share a common responsibility--to provide the public with clear, accurate information.

PETER B. CORR PhD

President of Pharmaceutical

Research and Development

Warner-Lambert

Morris Plains, N.J.