At FDA, Changes In Name Only–Agency Puts Business interests Above Safety

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

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

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…

Infomail Archive 2005

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 / Avonex Warning

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

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

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…

Infomail Archive, 2005

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…

Corporate Culture of Denial Results in Preventable Deaths

Corporate Culture of Denial Results in Preventable Deaths Fri, 7 Jan 2005 Failure to disclose the hazardous effects of Vioxx and Prozac are evidence of a corporate culture that has run amok. Uncovered company documents – some obtained through litigation, others unearthed by whistleblowers – reveal that the manufacturers knew…

Ethical and Scientific Objections to FDA’s Proposed Licensure of Anthrax Vaccine

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…