Propulsid Archives - Alliance for Human Research Protection

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…

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List of FDA-licensed prescription drugs withdrawn from US market for safety issues:
Between 1973 and 1991 (18 years) —16 drugs were withdrawan; Between 1992 and 2011 (19 years)—28 drugs were withdrawn.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.

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…

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:…

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,…

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…

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…

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,…

Alliance for Human Research Protection

Posts Tagged ‘Propulsid’

1999: Harmful experiments on the most vulnerabe

America’s Healthcare Crisis–Part II–What Do We Get for $$$ ?

US Healthcare Third Leading Cause of Death_Barbara Starfield, MD

Rx Drugs Recalled for Safety Issues from US market

Counter-Detailing Anti-drug Reps Coming to Educate Doctors

Role of Litigation in Defining Drug Risks_JAMA / BMJ