1999: Experiments on the most vulnerable The research community has consistently demonstrated its disregard for individual patient-subjects’ safety.  1999: One hundred babies are test subjects of the drug, Propulsid One hundred infants were enrolled by Dr. Susan Orenstein at Children’s Hospital (Pittsburgh) in a clinical trial testing Propulsid for…
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?
List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn.
The question is can these visits overcome industry's propaganda delivered under the guise of continuing medical education (CME) courses which physicians must take?
Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known.
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…
Linguistic Tinkering with Regulatory Terminology Increases Risk of Harm for Children: "minimal risk" "minor increment of minimal risk" and "disorder or condition" January 28, 2001 A cornerstone of the Declaration of Helsinki (adopted by the World Medical Association in 1964, and reaffirmed on Oct. 2000) is the distinction between research…
October 1, 2001 Text of AHRP Amicus Brief filed with the Maryland Court of Appeals in support of the Court’s ruling against Kennedy Krieger Institute for exposing children to lead poison in an experiment. The Court of Appeals Decision Validates AHRP’s Stand Against Using Children in Harmful Research Experiments. ___________________________________________________…
FDA: regulatory protections for children. Comments submitted by Vera Hassner Sharav, John H. Noble, Jr., Ph.D and Howard Fishman, MEd, MSW for AHRP August 6, 2001 To: Dr. Bernard Schwetz Acting Commissioner Food and Drug Administration Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville,…
