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 infant acid reflux—i.e., colic which…Read More
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List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn.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?Read More
Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known.Read More
THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the shift in public policy since…Read More
Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, & Pensions, United States Senate at…Read More
Testimony Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. April, 2001 AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of prescribing untested drugs for children,…Read More
Drug Warnings: Are They Effective? USA Today Tue, 26 Apr 2005 How effective are drug warnings? USA Today reports that experts are unsure. For example, a study in the January issue of Pharmacoepidemiology and Drug Safety focused on Ohio Medicaid claims for Rezulin prescriptions – the diabetes drug had been on the market for 3…Read More
Merck / Johnson & Johnson/ Lilly-Zyprexa: $690 Million settlement / a Flowering of Diabetes Drugs Fri, 10 Jun 2005 A cluster of news reports about three pillars of the pharmaceutical industry– Merck, Eli Lilly, and Johnson & Johnson–leave no doubt that this industry has shown its disregard for the welfare of the public, and through…Read More
Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT Mon, 26 Jul 2004 The New York Times reports that the Bush administration is actively blocking individual citizens who have been seriously harmed from drug-related hazards from suing drug manufacturers. The administration argues that “if a local judge or jury finds that a…Read More