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 In 1999, his data helped identify the risk of liver damage from Pfizer’s diabetes drug Rezulin — which eventually was withdrawn from the market….
Part II. What Do We Get for All That Money? A preventable epidemic of injury and death from prescription drugs; FDA’s contribution to the epidemic; Big Pharma’s business model: manufactured myths, propaganda and a hidden agenda;
Why didn’t Barbara Starfield’s Findings (JAMA 2000) cause a major overhaul of US medicine?
Since 1995 FDA scientists have been at odds against FDA managers who routinely override sientists’ safety concerns to approve dubious prescription drugs.
Since 1995 FDA scientists have been at odds against FDA managers who routinely override sientists’ safety concerns to approve dubious prescription drugs.
List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn.
Repeat legal violations: The record of recidivism by major drug manufacturers is a matter of public record.
Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known.
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, Rezulin and the antidepressant, Zoloft were named. In…
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 on facilitating new drug approvals. Officials at the…
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 recognizing that they are accountable for the public…
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 unsafe drugs. The pharmaceutical industry whose efforts to…
