China Daily update: Harvard genetic research in rural China Wed, 1 Oct 2003 “It’s the responsibility of the dean of the School of Public Health and, ultimately, it’s my responsibility as president of [Harvard] university to see to it that where wrong can be put right it is and, more…
Risks: Drugs / Vaccines / Trials / Treatment Evidence of antidepressant harm Oct 14, 2005: Andrew Finkelstein Letter to Dr. Russell Katz, Director, Neuropharmacological Drug Products, FDA about FDA’s Failure to Warn about Neurontin-Suicides Aug 29: FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks…
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…
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 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 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…
Jan 22, 1999 SCIENCE Volume 283, Number 5401, 22 Jan 1999, pp. 464 – 465 BIOETHICS NIMH to Screen Studies for Science and Human Risks Eliot Marshall For more than a year, patient activists and ethicists have been calling for a revolution in the way clinical studies in psychiatry are…
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…
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…
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. ___________________________________________________…
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 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,…
