Guidant Case May Involve Crime Inquiry Thu, 29 Sep 2005 The New York Times reports that “criminal investigators at the Food and Drug Administration have apparently become involved in the agency’s inquiry into how the Guidant Corporation handled problems with its heart devices, said two people contacted by the investigators."…
Paxil Protest at GSK US headquarters Sept. 26–Sept. 28 Sun, 18 Sep 2005 Families and victims who have suffered harm from SSRI antidepressants are heading for Philadelphia from the US and Canada for a “Paxil Protest.” Date: September 26 through Sept. 28. Place: GlaxoSmithKline US headquarters in Philadelphia The organizer of this event is…
Federal Court (Illinois) Rejects FDA-Daniel Troy Preemption Argument Fri, 11 Nov 2005 In yet another federal case (Zikis v Pfizer) involving the company’s failure to warn physicians and the public about the increased risk of suicide effects for pediatric patients prescribed Zoloft, the court rejected Pfizer’s argument that it didn’t need to war…
Abuses Endangered Veterans in Cancer Drug Experiments – NYT Sun, 6 Feb 2005 Paul H. Kornak pleaded guilty to fraud, making false statements and criminally negligent homicide in the death of an Air Force veteran, James DiGeorgio – one of the patients he used as subjects in medical experiments that…
Pfizer Acknowledges It Failed to Reveal Celebrex cardiac risk found in 1999 trial Tue, 1 Feb 2005 The New York Times reports: “Responding to the Vioxx withdrawal [Sept. 30, 2004], Pfizer said in October that no completed study had ever shown any increased heart risks related to Celebrex. Then, in…
Follow the Money / Can the Institute of Medicine Review the FDA? Wed, 6 Apr 2005 A letter to the editor published in Nature Medicine by Dr. Bernard Carroll, a past chairman of the FDA Advisory Committee for Psychotropic Drugs, and past chairman of the Department of Psychiatry at Duke…
FDA sends contradictory message re: addictive drugs prescribed for children – NIMH admits cognitive therapy as good as SSRIs Fri, 27 May 2005 Two government health care agencies sent conflicting mixed messages about th euse of psychotropic drugs for children: The National Instiute of Mental Health issued an announcement acknowledging…
FDA Public Health Advisory: SSRI-Suicide link in adults Wed, 20 Jul 2005 The American Medical Association is attempting to trivialize the hazards of prescribing SSRIs to children, urging physicians not to allow the evidence to interfere with their prescribing habits. See: http://www.ama-assn.org/ama/pub/category/print/15186.html The AMA has done the public a disservice…
Date: Thu, 30 May 2002 14:14:47 -0400 From: Vera Subject: Bitter Medicine: Pills, Profit & the Public Health_ABC News ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) A Human Rights Organization www.researchprotection.org Contact: Vera Hassner Sharav FYI On May 17 The Wall Street Journal reported (in a front page article) that drug…
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
Evidence of Antidepressant Harm that the FDA Sought to Suppress from FDA’s Public Advisory Committee Meeting on February 2 Evidence was presented on February 2 at AHRP’s press briefing by the following scientists: David Healy, MD, Director of the North Wales Department of Psychological Medicine and Visiting Professor, University of…
Government Investigations 1990 to August 2001 National Bioethics Advisory Committee Report: ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS, 1998 Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Asssurances (MPA) between January 1990 – June 2000…
