Press Statement – FDA & Concealment of Suicide-Related Risks of Antidepressants

We are witnessing the unraveling of a system that was intended to ensure that marketed drugs met high safety standards; that physicians were informed about potential, serious adverse drug effects – so that they would prescribe judiciously; and that the integrity of the scientific literature was preserved. But that system has been hijacked by the drug industry – which has infected medical practice and medical research with detail men and informercials that make false claims while manipulating partial data to conceal adverse drug effects.

FDA’s Waiting Game Exposes Children to Preventable Risks – 9/04 AHRP Comments to FDA

FDA’s Waiting Game Exposes Children to Preventable Risks Comments by Vera Hassner Sharav President The Alliance for Human Research Protection Submitted to FDA Advisory Committee Psychopharmacological Drugs Advisory Committee and Pediatric Subcommittee Drugs Advisory Committee September 13-14, 2004 Meeting RE: Suicidality Associated with Antidepressant Drug Treatment The Alliance for Human…

AHRP Press Briefing Re: Antidepressant Drug Risks

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave. Suite 28P, New York, NY 10023 ***PRESS RELEASE*** September 11, 2004 Contact: Vera Hassner Sharav, President, AHRP Tel. No: 212-595-8974 Cell: 917-375-5083 ***AHRP PRESS BRIEFING*** Re: Antidepressants and suicide-related risks for children When: September 14, 2004, 12:00 P.M. Where: Holiday…

Newsflash 3

AHRP is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to ensure that the human rights, dignity and welfare of human subjects are protected, and to minimize the risks associated with such endeavors.

FDA Failed to Disclose Suicide Risk to Advisory Committee

The BMJ news report (below) is included in the Congressional Record transcript of the Congressional hearing at which FDA officials were grilled about why they prevented Dr. Andrew Mosholder from delivering his analysis report  of the pediatric antidepressant clinical trials. http://a257.g.akamaitech.net/7/257/2422/12jan20051100/www.access.gpo.gov/congress/house/pdf/108hrg/96099.pdf

Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy

Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy Mon, 26 Jul 2004 On July 23, 2004, a citizen’s consumer protection lawsuit was filed against Pfizer Pharmaceuticals for concealment of evidence and deceptive marketing of the antidepressant Zoloft. The California law firm of Baum Hedlund has filed…

US Epidemic: Controlled Prescription Drug Abuse–Teen Drug Abuse Triples in 10 Years – CASA

US Epidemic: Controlled Prescription Drug Abuse–Teen Drug Abuse Triples in 10 Years_CASA Sat, 9 Jul 2005 “Our nation is in the throes of an epidemic of controlled prescription drug abuse and addiction,” said Joseph A. Califano, Jr., CASA’s chairman and president and former U.S. Secretary of Health, Education and Welfare….

Clinical Trials Controversy Spotlights Flawed System – Psychiatric News

Clinical Trials Controversy Spotlights Flawed System – Psychiatric News Mon, 19 Jul 2004 Recent independent analyses of the published and unpublished SSRI antidepressant pediatric data submitted by manufacturers to the FDA reveal not only that a disparity exists between published and unpublished data, but it becomes increasingly clear that the…

Cong Hinchey Rebukes Daniel Troy, Chief Counsel FDA, for financial conflict of interest

Cong Hinchey Rebukes Daniel Troy, Chief Counsel FDA, for financial conflict of interest Tue, 13 Jul 2004 Daniel Troy, the FDA’s chief counsel, is under fire for his financial conflicts of interest and for perverting FDA’s mission “to ensure that the public is protected from unsafe food, drugs and other…

FDA Squelches an Article Raising Doubts on Safety Of Device to Repair Artery – WSJ

FDA Squelches an Article Raising Doubts on Safety Of Device to Repair Artery – WSJ Fri, 9 Jul 2004 A front page article in The Wall Street Journal exposes another case of safety data suppression by the FDA. The case involves a device to repair the heart artery which FDA’s…