Two Court Rulings Reject Pfizer-FDA Preemption Claim in Zoloft “failure to warn” cases Thu, 21 Jul 2005 In a stunning federal court order JAMES M. ROSENBAUM, US Chief District Judge in Minnesota, overturned FDA-supported pre-emption arguments in their entirety! “The FDA has no authority to declare, ipse dixit, that a…
Healthy 19 year old volunteer suicides at Eli Lilly laboratory Tue, 10 Feb 2004 The Indianapolis Star reports (below) that Traci Johnson, a 19 year old healthy volunteer, one of 25 local paid volunteers committed suicide by hanging while testing Lilly’s drug, Duloxetine, at Lilly’s Laboratory for Clinical Research. Duloxetine…
Researchers Chastise Am J Psychiatry Over Skewed Celexa Study Thu, 31 Mar 2005 A letter by eight medical scientists (most from India, possibly all psychiatrists) have seriously challenged the scientific validity of an article published in the American Journal of Psychiatry. The lead author of the challenged study is one…
TIME – Medicating Young Minds with Mood / Behavior Altering Drugs Sat, 1 Nov 2003 A TIME magazine cover story (excerpt below) looks at the inordinate popularity of prescribing mood altering psychotropic drugs for children begins to raise troubling questions about the specter of doing long-term harm to children. Doctors…
AHRP Press Briefing Scientists Will Analyze SSRI Data – Families Will Tell Their Tragedies THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave. Suite 28P New York, NY 10023 January 27, 2004 Contact: Vera Hassner Sharav President, AHRP Tel. No: 212-595-8974 E-mail: Contact: Lisa Van Syckel Family Liaison…
Excerpt: The British drug authority has banned the use of most SSRI antidepressant drugs for the treatment of depression in children under 18, citing a two-to-threefold increased risk of suicidal behavior and lack of evidence of a benefit for depressed children. Two SSRIs – Paxil and Effexor – are no longer recommended by their manufacturer for use in children. Prozac is no longer recommended by Eli Lilly for children in the U.K.
In contrast to the British medicines authority review of the evidence, the FDA has refused to allow independent scientists to present documented evidence related to these drugs’ hazards and their failure to demonstrate a benefit for depressed children.
AHRP Correspondence with Government Agencies related link: FDA response to AHRP procedural questions (FDA sham conflicts of interest policy) FDA re: supression of SSRI evidence ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 https://ahrp.org Tel: 212-595-8974 e-mail: October 29, 2003 To: Thomas…
UK to crack down further on antidepressants given out ‘like sweets’ Tue, 21 Oct 2003 The British government is cracking down on reckless overprescribing of antidepression drugs (SSRIs) which are depleting public healthcare budgets. The Times (UK) reports that the National Institute for Clinical Excellence (NICE), the British government agency…
Prozac in Drinking Water / Prozac in Streams Hurt Frogs fish / Newborns suffer Withdrawal Tue, 10 Aug 2004 An article in the UK Observer–“Stay calm everyone, there’s Prozac in the drinking water” (below) — reports that British environmentalists are calling for an “urgent investigation into the revelations, describing the…
Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…
AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.
Debate Over Antidepressants – Letters NYT Mon, 11 Aug 2003 The New York Times published 5 letters re: “Debate Resumes on the Safety of Depression’s Wonder Drugs.” One letter from someone who experienced “a minor depressive episode” and was prescribed Celexa, one of the SSRI antidepressants. He describes experiencing “extreme,…
