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Inside the Mind of a Serial Drug Killer

This article was originally published in RPM Report

Executive Summary

The Cleveland Clinic's Steve Nissen has taken it upon himself to lead a drug safety crusade on behalf of patients that has ruined some high-profile drugs, elevated his status in the scientific world and captivated the drug industry. Why is he doing it-and will he continue?

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A Tale of Two Drugs: Meridia and Avandia, and the Issues that Separated Them

Avandia and Meridia are different drugs with parallel regulatory histories: both are long-marketed treatments for metabolic disease. Both have an increased risk of cardiovascular events. And both were considered for withdrawal at roughly the same time by the same FDA division. But while there were many similarities between the two, the reviews were markedly different with markedly different outcomes.

A Tale of Two Drugs: Meridia and Avandia, and the Issues that Separated Them

Avandia and Meridia are different drugs with parallel regulatory histories: both are long-marketed treatments for metabolic disease. Both have an increased risk of cardiovascular events. And both were considered for withdrawal at roughly the same time by the same FDA division. But while there were many similarities between the two, the reviews were markedly different with markedly different outcomes.

FDA's Cleveland Clinic and Duke Connection

Steven Nissen (Cleveland Clinic) and Robert Califf (Duke) are well known advisers to FDA: outside experts the agency turns to on thorny issues -- especially involving cardiovascular risks. What is less recognized is the prominence of the institutions that Nissen and Califf represent and their impact on the FDA advisory committee process. The agency currently has a dozen advisory committee members from the Cleveland Clinic and Duke.

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