Three Questionable FDA policies: drug factory inspection rules/ clinical trials/ Paxil ads Thu, 22 Aug 2002 Three news items highlight questionable FDA policies that are in conflict with consumer health interests. 1) Poor quality control standards in American drug and vaccine manufacturing plants is a disgrace. The Associated Press reports…
FDA Alert: Effexor warnings added for neonatal adverse effects and suicidality risk Tue, 29 Jun 2004 On June 28, the FDA and Wyeth issued a new MedWatch drug Alert to healthcare professionals: “Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late…
FDA May Require Longer Studies Before Approving Psych Drugs – WSJ Tue, 18 Oct 2005 The Wall Street Journal reports that the FDA has sent out feelers to drug manufacturers to provide “longer-term efficacy data” for psychotropic drugs. This comes after a mountain of evidence shows placebo “works” just as…
War hero’s death in clinical trial follows years of FDA neglect – Bloomberg News Thu, 10 Nov 2005 Bloomberg News reports that a decorated veteran of the Vietnam war was killed in 2002, in a clinical drug trial at the FABRE Research Clinic in Houston, Texas. The FDA had found…
FDA Advisory Suicide Risk for Adults on Antidepressants / Advisory Committee Resistant to issue Warnings on ADHD drugs Fri, 1 Jul 2005 Under public and congressional pressure to disclose fully the hazardous effects of widely prescribed drugs, the FDA is beginning to acknowledge the long-denied evidence: psychotropic drugs may INDUCE…
FDA Cut Off Critic’s Access to Drug Safety Database – Chicago Tribune Thu, 24 Feb 2005 The Chicago Tribune reports (below) about an eggregious example of the abuse of power by FDA officials who are retaliating against an independent scientist whose unique research project for detecting rare adverse drug reactions…
Cover Letter – AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine related links: Comments Submitted to FDA re Anthrax Vaccine (312K pdf) Who Is Protecting The Public Health? By Meryl Nass, Z Magazine March 29, 2005 Lester Crawford, Ph.D., D.V.M. Acting FDA Commissioner U. S. Food…
AHRP InfoMail Return to Home Page Return to InfoMail Media Coverage List MediaCoverage News Stories on Human ResearchProtection andCommentary by Vera Hassner Sharav March 15a, 2002 Harm to Alzheimer ExperimentalPatients FYI ABC reports that Bob Helms, the self-described humanguinea pig, has written a book about his experience and observations about…
More detailed comments Children should not be tested for the Dryvax vaccine for the following reasons: 1) The original trials for the Dryvax vaccine already show that children respond similarly to adults when administered this substance. Since the effective dosage for adults has already been tested, it would be…
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 &…
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…
TeenScreen: Who Pays for Treatment and Drugs?? Sun, 29 May 2005 In her latest examination of the President’s Commission on Mental Health recommendation for universal mental health screening, Evelyn Pringle focuses on the $$$ it costs and on how screening, followed by prescribing psychotropic drugs, is bankrupting of public health…
