GlascoSmithKline PAXIL Warning letter to Healthcare Professionals Thu, 19 Jun 2003 On June 10 the British government disapproved a license the widely popular, SSRI antidepressant, Seroxat (PAXIL), for use in children and adolescents after a committee examined the data from 9 clinical trials. The British Medicine and Healthcare Products Regulatory…
FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald Wed, 29 Oct 2003 The Washington Post correctly reports: “The association between antidepressants, particularly the selective serotonin reuptake inhibitors (SSRIs), and suicide has been controversial since the first SSRI, Prozac, came on the market in the late 1980s.” But stakeholders in…
FDA Foot Dragging – Three Months After Expert Panel Urged “Black Box” Warnings for Antidepressants, No Action Thu, 23 Dec 2004 Why is the FDA failing to enforce the "Black Box" warnings on SSRI antidepressant drug labels? When questioned by the NJ Star Ledger, Robert Temple, director of the FDA’s…
FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Biogen issues Avonex Warning Fri, 18 Mar 2005 It would be impossible to gain insight into Lester Crawford’s confirmation hearings by the Senate Health, Education, Labor and Pensions committee if one read only one news report. The Los…
FDA Approves Lilly’s Cymbalta for Depression Despite Risk of Suicide Wed, 4 Aug 2004 In a display of arrogance and defiance–in the midst of federal investigations into the marketing of antidepressants–the FDA has approved Eli Lilly’s antidepression drug, Cymbalta (duloxetine). Lilly’s press release announced: “Cymbalta, a balanced and potent reuptake…
House Votes to Prevent Pharma-tied Scientists on FDA Advisory Panels Thu, 9 Jun 2005 The House passed an amendment introduced by Congressman Maurice Hinchey (NY) to rein in pharmaceutical industry influence on FDA advisory panels whose recdommendations have resulted in the approval of lethal drugs. Below Merrill Goozner write: “The…
Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine Fri, 01 Apr 2005 Government agencies are maneuvering to weaken legal protections prohibiting the exposure of human beings to experimental drugs, vaccines and procedures without their voluntary informed consent. Even after a federal court has ordered the Pentagon to…
THE ALIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Avenue, Suite 28P New York, NY 10023 www.ahrp.org FDA Docket Number 02N-0466 Comments re: Proposed smallpox vaccine trial to test the safety of Dryvax administration to children 2 to 5 years of age Recent public and professional debate about smallpox…
Simply put, I am opposed to the vaccine study. These children’s immune systems are not yet fully mature and I feel their systems are already overwhelmed by the numerous vaccines they are given. Why risk a live virus vaccine in our country where no cases exist? I feel the threat…
Testimony Submitted to the Office of Human Research Protection (OHRP) by Vera Hassner Sharav and Marie M. Cassidy, Ph.D, D.Sc. April, 2001 AHRP recognizes that to include children in clinical trials for any medication presents a dilemma of truly Solomonic proportions. It is a choice between continuing the practice of…
Someone Tell Brooke Shields the Truth!! Mon, 4 Jul 2005 On this American independence day, thousands of families strive for drug free schools–and they’re not worrying about illegal drugs, their main concern is coercive prescribed amphetamines and other mind-altering psychotropic drugs. Other than the critical reaction of actor Tom Cruise,…
Depressed? NYC Screens for People at Risk – NY Times Wed, 13 Apr 2005 A front page article in The New York Times reports that the New York City Department of Health and Mental Hygiene, has instructed doctors at City hospitals – who care for one in four New Yorkers…
