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…
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…
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 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 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Spotlights Flawed System – Psychiatric News Mon, 19 Jul 2004 Recent independent analyses of the published and unpublished SSRI antidepressant pediatric data submitted by manufacturers to the FDA reveal not only that a disparity exists between published and unpublished data, but it becomes increasingly clear that the…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 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 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…
Conflict of Interest: Profits vs Safety Congressional Investigations US Senators Pharmaceutical industry holdings, 2004: http://www.consumerwatchdog.org/resources/SenPharma.pdf Oct 12: How Did the Vioxx Debacle Happen? USA Today / Lancet Oct 4: Op Ed: Psychiatry on the Ropes–WP / Evidence-based Psychiatry Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical…
Law Suits and Court Decisions Sep 15 2005: FDA Amicus Curiae–Kallas–claims FDA infallibility pre-empts state safety laws (warning: 1.6 MB file) Aug 6 2004: Psychiatrist Scolds the APA After Winning Distinguished Fellow Award/ NYC Sues 44 Pharma Companies Aug 5: Pfizer issues prosecutors a manual to defend drug – Star…
FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data – WashPost Tue, 6 Jul 2004 A front page article in The Washington Post reports that the FDA failed to enforce the law that requires drug companies to disclose ALL clinical drug trials and ALL trial findings-whether they’re good…
Today’s (6/30/04) editorial, “Missing Drug Data,” misses the point and argues with the pharmaceutical industry and its allies in the Congress, the NIH and the FDA that data can be selectively reported to satisfy commercial interests. This is a blatant attack on Karl Popper’s falsifiability principle on which empirical science depends to make progress. One needs all the data in order to verify the results of clinical or any other kind of research. Most academics and pundits know that any case can be made if allowed to manipulate the data and assumptions. The AMA, the medical journal editors, and Eliot Spitzer, all deserve applause from the Washington Post editor-not quibbling about the possible damage that somehow, somewhere might result from strict embrace of the principles and practice of scientific inquiry. It’s all about transparency.
John H. Noble, Jr.
