Cong Hearing Re: Disclosure Pediatric SSRI Trials Wed, 7 Jul 2004 A hearing has been tentatively set for July 20th by the House subcommittee on oversight and investigations, chaired by Congressman James Greenwood. The hearing will address issues of disclosure involving pediatric antidepressant drug trials–or more accurately, non-disclosure of adverse…
WSJ: Debate Over Antidepressants: FDA role in suppressing damaging data Tue, 25 May 2004 How were drug manufacturers able to conceal vital evidence of harmful antidepressant drug effects? The answer is becoming clearer by the day: federal regulators and the psychiatrists who tested these drugs in clinical trials are invested…
What’s in a Warning? Antidepressants and Risk of Suicide – FindLaw Thu, 22 Apr 2004 Contrary to the published reports in the peer-reviewed journals, the preponderance of evidence demonstrates that antidepressants pose a greater risk than a benefit for children. *[References below] Informed medical treatment decisions hinge on the decision…
Antidepressant Ban for Kids Puts Pressure On U.S. / Canada Mon, 15 Dec 2003 The British government ban for use of all but one SSRI antidepressant drug in children and teens (Dec 10, 2003) is reverberating wherever these drugs are widely prescribed. The action was taken after an independent committee…
"Risks of anaphylaxis applies to all studies at PAREXEL, with drugs at every stage of development, and the staff are well trained in anticipation of this (unlikely) possibility.
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…
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.
