1999: Harmful experiments on the most vulnerabe

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 . . . Continue reading →

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

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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;

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Role of Litigation in Defining Drug Risks_JAMA / BMJ

Documents uncovered during the course of litigation shed light on real risks of drug-induced harm that would not otherwise be known. Continue reading →

Linguistic Tinkering with Regulatory Terminology Increases Risk of Harm for Children

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 . . . Continue reading →

AHRP Files Court Brief to Protect Children from Harmful 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 . . . Continue reading →

FDA: Regulatory Protections for Children. Comments by Sharav, Noble, & Fishman for AHRP

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 . . . Continue reading →

Dissenting Opinion: Against waiving parental permission for research

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 . . . Continue reading →

The Impact of the FDA Modernization Act on the Recruitment of Children for Research

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 . . . Continue reading →

Protecting Human Subjects in Research: Are Current Safeguards Adequate?

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 . . . Continue reading →