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 . . . Continue reading →

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 . . . Continue reading →

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 . . . Continue reading →

Science & Ethics Hold Up EPA Nomination: pesticide experiment draws fire

Science & Ethics Hold Up EPA Nomination: pesticide experiment draws fire Fri, 08 Apr 2005 The Los Angeles Times reports that Senator Bill Nelson of Florida is equally outraged about the Environmental Protection Agency pesticide experiment that would expose 60 poor babies . . . Continue reading →

FDA Smoke & Mirrors Musical Chairs

FDA Smoke & Mirrors Musical Chairs Wed, 16 Feb 2005 Amidst widespread public criticism of the FDA’s role as facilitators in the marketing of lethal drugs that killed thousands of people, the Administration made several announcements incorporating terminology (such as: “we’re in . . . Continue reading →

FDA Regulators Accused of Trying to Quash Testimony About Cardiac Risks of Painkillers – NYT

FDA Regulators Accused of Trying to Quash Testimony About Cardiac Risks of Painkillers – NYT Sat, 12 Feb 2005 A New York Times front page report announces that President Bush will veto any limits on the Medicare prescription drug giveaway. The administration . . . Continue reading →

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 . . . Continue reading →

TIME inquiry finds top officials at vital gov agencies lack credentials for the job

TIME inquiry finds top officials at vital gov agencies lack credentials for the job Date: Wed, 28 Sep 2005 The New York Times reports today that the mystery of Lester Crawford’s abrupt resignation as head of the FDA “fueled speculation that he . . . Continue reading →

The Crawford Resignation Mystery

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 . . . Continue reading →

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 . . . Continue reading →

How Did the Vioxx Debacle Happen? USA Today / Lancet

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 . . . Continue reading →