To view AHRP news and infomails from 2006, please visit our new site. Infomails Subscribe to AHRP’s infomails At FDA, Graham is still the whistle-blower Loss of Trust: Big Drug Makers See Sales Decline With Their Image War hero’s death in clinical trial follows years of FDA neglect European perspective:…
Medication switched for research purposes – patient nearly dies Tue, 11 Nov 2003 The Boston Globe reports that an investigation by a state oversight agency, “uncovered numerous ethical violations at the Solomon Carter Fuller Mental Health Center by Boston Medical Center physicians contracted to treat patients there.” Boston University Medical…
ALLIANCE FOR HUMAN RESEARCH PROTECTION* (AHRP) April 10, 2000 Gary Ellis, Ph.D, Director Michael A. Carome, M.D. Chief Compliance Oversight Branch Division of Human Subject Protections Office of Protection from Research Risks Rockville, MD 20892-7507 Re: High Risk Experiment With Children Who Have No Medical Diagnosis Dear Dr. Ellis &…
Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS Sun, 26 Dec 2004 A government survey by the U.S. Department of Health and Human Services, confirms that Americans are the most medicated population in the world – 44 percent of Americans had…
AHRP Speaks Out AHRP Press Briefing 9/14/04: Antidepressants & suicide-related risks for children Open Letter to NIMH re Prozac & Concealed Suicide Attempts Open Letter to Officials at NIMH AHRP Briefing 2/2/04: Scientists present suicide evidence Conflicts of Interest policy – New York Times Phase I Drug Trials Used Foster…
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…
