Vice president of diabetes research at Warner-Lambert, Dr. Randall W. Whitcomb told the Endocrine and Metabolic Drugs Advisory Committee of the FDA in December 1996 that the liver damage incidence was comparable to placebo. At the time the company had known at least 12 people had suffered serious cases of Rezulin liver damage during clinical trials. In reality, though, the placebo studies were not comparable to Rezulin patients. Just 0.6% of the placebo pills suffered liver problems opposed to 2.2% of the Rezulin liver damage patients. When asked about this discrepancy after the Rezulin recall, Whitcomb claimed the numbers were not “all that different.”

Warner-Lambert, now owned by Pfizer Inc, is now trying to defend against the hundreds of Rezulin lawsuits that have emerged due to the serious Rezulin liver damage and heart damage effects. Contact us to speak with an expert Rezulin liver damage lawyer.

Dr. Paresh Dandona, the endocrinologist who served as Warner-Lambert’s principal investigator for the Echo study in Buffalo, said, “The Echo Study was not properly conducted, according to the standard protocol. I was not made aware of the fact that the patients from this site, in particular, for whatever reason, whether it was due to technique or whatever, that they had increased left ventricular mass,” (L.A. Times, 3-26-00). Dadona also added that he had delegated a majority of the work to heart specialists that had deviated from the Echo Study procedures when studying up to one third of the Rezulin patients.

As far back as October 18, 1996, concern was raised over the safety of Rezulin in regards to its potential for adverse heart effects. Dr. Robert I. Misbin, an FDA diabetes specialist, wrote an email to a former FDA medical officer who had studied Rezulin in the 1990’s and recommended its rejection, Dr. John L. Gueriguian, saying, “my primary concern about Rezulin is related to its potential for cardiac toxicity,” (L.A. Times, 3-26-00). Many diabetes patients, an estimated 15 million Americans, are overweight and have a far higher risk of developing congestive heart failure, which made the issue of the use of Rezulin and its potential to cause heart problems especially important.

After the FDA approval of Rezulin on January 29, 1997, officials had negotiated a nonbonding pledge from Warner-Lambert to start a new study to assess Rezulin’s effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed. Rezulin patients did die of heart failure, but doctors claimed many of these patients had preexisting heart problems. Guston Turner, a pharmacist from the FDA’s scientific investigations division had found inconsistencies in research measuring Rezulin’s effect on the heart. Turner felt that the FDA “should have delayed approval of Rezulin until all the questions were addressed,” (L.A. Times, 3-26-00).

Serious, life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of deaths from liver failure and thousands of other Rezulin liver damage cases from 1997-2000. Contact us to speak directly with an expert Rezulin liver damage lawyer.

A 1998 Public Citizen survey found the FDA could require manufacturers to conduct phase IV studies as a condition of approval. According to the reports, at least one phase IV study was required for 195 of 306 new drugs approved by the FDA during the 1990s, but just 11 of the 195 Phase IV studies had been completed. This pertains to the safety of Rezulin because a complete clinical trial was not completed prior to the FDA approval of the diabetes drug due to the "fast track" method used on the drug. After Rezulin was approved, official negotiated a nonbonding pledge from Warner-Lambert to start a new study to assess Rezulin's effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed.