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…
10 of 32 FDA Vioxx Panelists Had Industry Ties_NYT / Cozy NIH Review “Clears” NIH Industry Ties_WashPost Fri, 25 Feb 2005 The latest example of the corrupting influence of the pharmaceutical industry on health care policy is the composition of FDA’s advisory panel that last week endorsed the marketing of…
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 Scientist Won’t Present New Pain Drug Data – FDA to Create Independent Drug Safety Board Tue, 15 Feb 2005 A culture of intimidation prevents FDA safety officers from disclosing important safety information about widely marketed drugs. Reuters reports: “Criticism of how the FDA monitors the after-market safety of drugs…
THE CONSTANT GARDENER–John le Carre’s novel about Big Pharma gets rave reviews Sat, 3 Sep 2005 Constant Gardener, the movie based on the novel by John le Carre, about the pharmaceutical industry’s immoral and even criminal activities, opened nationwide. It has already received rave reviews. Below are two reviews…
FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT Fri, 4 Mar 2005 The Washington Post reports about yet another instance of a high FDA official who misspoke. Dr. Sandra Kweder, Deputy Director of FDA’s Office of New Drugs, sent a letter, “written…
Bill would shield some drug firms from punitive damages Wed, 29 Dec 2004 A proposed bill in Congress would be another disincentive for pharmaceutical companies to disclose drug safety problems. Those promoting the bill should be asked to disclose their financial ties to drug companies. In 2000, a mysterious clause…
BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception Sun, 3 Oct 2004 BBC-Panorama is airing its third in a series of investigative reports about the betrayal of trust in psychiatry, drug manufacturers and government regulators. The first program, The Secret of Seroxat, aired October 13, 2002, revealed…
http://www.npr.org/templates/story/story.php?storyId=4696609 Documents Suggest Merck Tried to Censor Vioxx Critics NATIONAL PUBLIC RADIO All Things Considered, June 9, 2005 – Because of intense interest in this report, NPR has decided to present a full transcript. Introduction: At least 38,000 Americans are believed to have died from taking the pain pill Vioxx…
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
Forbes: Judgment Day for the FDA, Pfizer Wed, 9 Feb 2005 On Feb. 16-18 COX-2 Inhibitor Safety Issues will be the focus of an FDA Advisory Committee and (simultaneously) the European Medicines Agency (EMA). The entire drug industry will be watching with bated breath. Which causal explanation will be offered…
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…
