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List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn.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
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 hide the adverse effects of…Read More
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 that is intended to be…Read More
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. ___________________________________________________ IN THE COURT OF APPEALS…Read More
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, MD 20857 Re: COMMENT ON:…Read More
Dissenting Opinion: Against Waiving Parental Permission for Research July 25, 2001 To: Mary Faith Marshall, Ph.D, Chairperson, National Human Research Protections Advisory Committee Department of Health and Human Services Re: Specific Comment on FDA’s Decision to Adopt HHS 45 CFR 46 Subpart D, EXCLUDING §46.408 (c) Dissenting opinion of Vera Hassner Sharav, Founder and President,…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