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,…
April 2003. American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf ABSTRACT (attached & below) This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have…
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, &…
Concealed NIH Review Substantiates Fired Expert’s Concerns – AP Mon, 4 Jul 2005 The Associated Press reports that a 2004 internal report by the National Institutes of Health validates the allegations by Dr. Jonathan Fishbeing, the NIH ethics-safety expert who was fired for reporting unethical and scientifically flawed AIDS resesrch…
FDA New Drug Safety Website – ADHD A Huge Profit-Engine for amphetamine-like drugs – The Street Sun, 22 May 2005 “After 25 years and 35 studies, there is not a single straightforward experiment comparing typical unmedicated children with an ADHD diagnosis to typical controls.” But science is not what the…
FDA Requests Anticonvulsant Suicide Data Analysis – Boston Globe Wed, 20 Apr 2005 Thanks to the persistent advocacy efforts of attorney, Andrew Finkelstein, the FDA has finally sent letters to 14 manufacturers of anticonvulsant drugs, such as Pfizer’s Neurontin, to examine the suicide data from these drugs. Finkelstein began his…
NIH Chief Calls for Ethics Summit to address Conflicts of Interest in Medical Research – LA Times Mon, 14 Feb 2005 AHRP applauds Dr. Elias Zerhouni, director of the National Institutes of Health, for stepping up to the plate as a leader of an agency that will award about $21…
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…
THE CONSTANT GARDENER–John le Carre’s novel about Big Pharma gets rave reviews Sat, 3 Sep 2005 Constant Gardener, the movie based on the novel by John le Carre, about the pharmaceutical industry’s immoral and even criminal activities, opened nationwide. It has already received rave reviews. Below are two reviews…
AMA Serves Pharma Marketing Priority/ FDA To Add Warnings on ADHD drugs–Concerta, Ritalin, Strattera, Adderall Wed, 29 Jun 2005 The FDA is finally taking note of the fact that many drugs prescribed for the treatment of psychiatric problems are CAUSING serious psychiatric and cardiovascular problems in children and adolescents !…
Opinion column: Antidepressants Carry Risk– Dr. Joseph Glenmullen Sat, 5 Mar 2005 A hard corps of influential mental health professionals continue to mislead the public‹parents in particular–about the very real and proven risks of antidepressant drugs. In some people‹especially youngsters‹antidepressants have triggered violent and suicidal behavior. Because of the compelling…
FATAL FLAW Efforts to Overturn SSRI Black Box warning before it has even been implemented Date: Mon, 24 Jan 2005 Even as the Black Box Suicidality Warning on SSRI antidepressant labels have not even been implemented, aggressive efforts are underway by a powerful consortium of medical-pharmaceuticaql self-interest groups – among…
