What the FDA Isn’t Telling You – SLATE Date: Tue, 27 Sep 2005 Writing in SLATE, Jeanne Lenzer has uncovered evidence demonstrating FDA culpability in helping drug manufacturers conceal vital, life-saving information from the public. In this case, undisclosed suicides in clinical trials testing Eli Lilly’s drug, duloxetine (trade names:…
Daniel Troy Legacy: Public Virtually Defenseless against Unsafe Drugs Thu, 18 Nov 2004 The Associated Press reports that at a Congressional hearing today, Dr. David Graham a drug safety expert at the FDA told the Senate Finance Committee that the public is “virtually defenseless” if another medication such as Vioxx…
The Crawford Resignation Mystery Sat, 24 Sep 2005 Merrill Goozner of Center for Science in the Public Interest provides insight into what may lie behind the sudden resignation of FDA Commissioner, Lester Crawford. Goozner surggests, “One possible clue to the administration’s thinking comes from the appointment of Andrew von Eschenbach,…
At FDA, Changes In Name Only–Agency Puts Business interests Above Safety Fri, 30 Sep 2005 The sudden resignation of FDA Commissioner, Lester Crawford, after just two months in office, has prompted a bipartisan Senate investigation and requests both by the Senate committee HELP and by congressman Maurice Hinchey (NY) and…
FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk Fri, 15 Oct 2004 We have won the first battle in a struggle for full disclose of serious adverse drug effects and disclosure of failed clinical trials. Prescribing physicians and the public have…
FDA Commissioner Lester Crawford Resigns – AP Fri, 23 Sep 2005 The Associated Press reports that the embattled FDA commissioner, Lester Crawford, a veterenarian, who headed the agency since Marc McLellan moved over to the Center for Medicare & Medicaid Services, has resigned effective immediately. Contact: Vera Hassner Sharav 212-595-8974…
How Did the Vioxx Debacle Happen? USA Today / Lancet Tue, 12 Oct 2004 Dr. Eric Topol of the Cleveland Clinic: “The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public…
Infomail 2005 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Subscribe to the AHRP infomail list Dec 16: Drugs, Devices & Doctors – NYT Paul Krugman Dec 11: Scientific Fraud & Corruption on Both sides of Atlantic: Merck / Proctor & Gamble Dec 11: Gov Accountability…
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 Critics Slam Plan for Safety Reform – Nature Thu, 17 Feb 2005 This is smoke and mirrors and musical chairs. Vera Sharav Alliance for Human Research Protection, New York http://www.nature.com/news/2005/050214/full/050214-11.html Published online: 17 February 2005; | doi:10.1038/news050214-11 FDA critics slam plan for safety reform Emma Marris Calls grow for…
Pfizer CEO earned $16 milion-72% Increase / V-P Tells Congress How to Save $37.8 billion in cost of drugs Thu, 10 Mar 2005 In his February 16 testimony before the Senate Committee on Health, Education, Labor and Pensions, Dr. Peter Rost, Pfizer V-P for Marketing, said: “Every day Americans die…
Cover Letter – AHRP Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine related links: Comments Submitted to FDA re Anthrax Vaccine (312K pdf) Who Is Protecting The Public Health? By Meryl Nass, Z Magazine March 29, 2005 Lester Crawford, Ph.D., D.V.M. Acting FDA Commissioner U. S. Food…
