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 →

How Did the Vioxx Debacle Happen? USA Today / Lancet

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 . . . Continue reading →

Trial Lawyers Are Taking Aim at the Drug Industry_NYT

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 . . . 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 →