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List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn.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 Double Standard Re: Advisory Committee Membership Mon, 15 Nov 2004 FDA’s inexplicable actions–the latest being the removal of Dr. Curt Furberg from an FDA advisory committee for alleged "intellectual conflict of interest" – demonstrate hypocracy and intellectual dishonesty. Dr. Furberg independently . . . 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 →