FDA Bad Faith – Daniel Troy’s pre-emption defense – Nat’l Law Journal

FDA Bad Faith – Daniel Troy’s pre-emption defense – Nat’l Law Journal Fri, 26 Mar 2004 Federal regulations require drug label warnings if there is “reasonable evidence” of a link between adverse effects and drug action. An article in the National Law Journal shows how s FDA’s chief counsel, Daniel…

AHRP in the News

Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that…

Infomail Archive 2005

Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…

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 research stakeholders in industry, academia and government, the…

Cost and Consequence: drug "cocktails" deplete Medicaid_Globe

Cost and Consequence: drug “cocktails” deplete Medicaid_Globe Tue, 24 Jun 2003 The escalating cost of healthcare is in large measure due tothe spiraling expenditure on drugs–many of which are misprescribed.The Boston Globe reports about one Medicaid patient who is prescribed18 medications at a cost of roughly $16,000 a year–“all at…

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Screening for Mental Illness: The Merger of Eugenics and the Drug Industry

Ethical Human Psychology and Psychiatry Volume 7, Number 2, Summer 2005 pp. 111-124 Screening for Mental Illness: The Merger of Eugenics and the Drug Industry Vera Hassner Sharav, MLS New York, NY The implementation by the President’s New Freedom Commission (NFC) to screen the entire United States population – children…

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 Against Using Children in Harmful Research Experiments. ___________________________________________________…

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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 Public Health, Committee on Health, Education, Labor, &…

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 Drug Administration 5630 Fishers Lane, Room 1061 Rockville,…

Risk Bearing Children

Risk Bearing Children February 27, 2001 Would you volunteer your child to be a "risk-bearing" subject in drug experiments? When Jonathan Swift published A Modest Proposal in 18th century Ireland, he offered a sure solution to the country’s hunger and economic ills: The poor could sell their year-old children as…