David Graham, MD, FDA’s Associate Director of Science and Medicine who, throughout his career, has been a thorn for FDA managers by identifying hazardous drug effects. In 1999, his data helped identify the risk of liver damage from Pfizer’s diabetes drug Rezulin . . . Continue reading →
Why didn’t Barbara Starfield’s Findings (JAMA 2000) cause a major overhaul of US medicine?
List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn. Continue reading →
Repeat legal violations: The record of recidivism by major drug manufacturers is a matter of public record.
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Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known. Continue reading →
FDA’s Lethal Weakness Requires More than Committees Sun, 7 Nov 2004 Bloomberg News reports that New York State Attorney General Eliot Spitzer requested information from Pfizer about the promotion of some of its drugs for unapproved uses – the recalled diabetes drug, . . . Continue reading →
FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle Mon, 29 Nov 2004 The Food and Drug Administration is the epicenter of a collision between medical officers in the drug safety office and senior officials in managerial positions whose focus is . . . Continue reading →
How Did the Vioxx Debacle Happen? USA Today / Lancet Tue, 12 Oct 2004 Dr. Eric Topol of the Cleveland Clinic: “The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not . . . Continue reading →
Trial Lawyers Are Taking Aim at the Drug Industry_NYT Sun, 18 May 2003 It appears that trial lawyers will produce the results that government oversight agencies–in particular, the FDA–have failed to do. Namely, to protect the public against an increasing number of . . . Continue reading →