Propulsid


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. ___________________________________________________ […]

AHRP Files Court Brief to Protect Children from Harmful Research


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, […]

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


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 […]

Dissenting Opinion: Against waiving parental permission 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 research stakeholders in industry, academia and government, the […]

The Impact of the FDA Modernization Act on the Recruitment ...


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, & […]

Protecting Human Subjects in Research: Are Current Safeguards Adequate?


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 […]

Sharav / Cassidy – OHRP Testimony, 4/01



Drug Warnings: Are They Effective? USA Today Tue, 26 Apr 2005 How effective are drug warnings? USA Today reports that experts are unsure. For example, a study in the January issue of Pharmacoepidemiology and Drug Safety focused on Ohio Medicaid claims for Rezulin prescriptions – the diabetes drug had been […]

Drug Warnings: Are They Effective? USA Today


Merck / Johnson & Johnson/ Lilly-Zyprexa: $690 Million settlement / a Flowering of Diabetes Drugs Fri, 10 Jun 2005 A cluster of news reports about three pillars of the pharmaceutical industry– Merck, Eli Lilly, and Johnson & Johnson–leave no doubt that this industry has shown its disregard for the welfare […]

Merck / Johnson & Johnson/ Lilly-Zyprexa: $690 Million settlement / ...


Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits – NYT Mon, 26 Jul 2004 The New York Times reports that the Bush administration is actively blocking individual citizens who have been seriously harmed from drug-related hazards from suing drug manufacturers. The administration argues that “if a local judge […]

Mosholder Suppressed Report Posted/ Bush Moves to Block Medical Suits ...



FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle Mon, 29 Nov 2004 The Food and Drug Administration is the epicenter of a collision between medical officers in the drug safety office and senior officials in managerial positions whose focus is on facilitating new drug approvals. Officials at the […]

FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle