Doctor’s Misconduct Left Trail of Broken Lives–A Broken Marriage and a ‘Life Destroyed’ – WashPost

Doctor’s Misconduct Left Trail of Broken Lives–A Broken Marriage and a ‘Life Destroyed’ – WashPost Mon, 29 Sep 2003 “I basically lost everything. And my kids? Well, who knows what the long-term damage might be.” A riveting, detailed, two part report in the Washington Post (Sunday, September 28) describes a…

AstraZeneca Pleads Guilty in Criminal Cancer Medicine Scheme

AstraZeneca Pleads Guilty in Criminal Cancer Medicine Scheme Sun, 22 Jun 2003 AstraZeneca agreed to a $355 million settlement in civil and criminal charges. Government prosecutors found that AstraZeneca reported to the government that the average wholesale price for a monthly dose of the prostate cancer drug, Zoladex, was about…

AHRP Comments Re: Best Pharmaceuticals for Children’s Act of 2002

Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…

Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.

Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT

Rehnquist Warns Drug Makers _Marketing Actimune for Unapproved Use_NYT Mon, 28 Apr 2003 1. The New York Times reports that Janet Rehnquist, the Inspector General of the Department of Health and Human Services, has issued “a compliance guide for drug manufacturers” in which they are waned that many of their…

Dissenting Opinion – Proposed Children’s Workgroup Reinterpretation of Fed Regs 45 CFR 46 sects. 404 & 406

Dissenting Opinion (NHRPAC Children Workgroup) re: Proposed Reinterpretation of Fed. Regs Protecting Children (45 CFR 46, sections 404 and 406) May 14, 2002 To: Alan Fleischman, MD, Chair, Children’s Workgroup of NARPAC        Mary Faith Marshall, Ph.D., Chair, NARPAC From: Vera Hassner Sharav Re: Dissenting Opinion re: Report to NHRPAC, proposing…

Protecting Human Subjects in Research: Are Current Safeguards Adequate?

Current federal regulations set no limits on the level of risk that a competent adult may voluntarily choose to undertake for the sake of science. The regulations require prior approval by a review board (IRB) to ensure the research meets scientific and ethical justification, to ensure that the risks and benefits (if any) are fully disclosed to the subject, and that the subject can exercise the right to give or withhold informed consent.