Grassley Calls for Safety Review /Unsafe Drugs Marketed to Consumers / FDA Lacks Leadership Sun, 19 Dec 2004 “We expect the FDA to not put a drug on the market that’s not safe. And you can’t compromise safety, regardless of how much pressure there is to get more drugs on…
Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…
Congressional Investigations Senate Finance Committee Investigates FDA Aug 4: Sen. Grassley letter (416 K pdf) to 8 drug companies requests list of all antidepressant tests on children (1/1/1990–7/23/2004) Aug 3: Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data Jul 15: Senate Letter to FDA re: disclosure of risks…
Sen Grassley Expands Investigation – Why did FDA approve Vioxx for Children??? Mon, 18 Oct 2004 The Financial Times of London and The Washington Post report that the Senate Finance Committee is expanding its probe of the FDA and its cosy relationship with drug manufacturers. The Vioxx debacle is but…
Cong Hearing Re: Disclosure Pediatric SSRI Trials Wed, 7 Jul 2004 A hearing has been tentatively set for July 20th by the House subcommittee on oversight and investigations, chaired by Congressman James Greenwood. The hearing will address issues of disclosure involving pediatric antidepressant drug trials–or more accurately, non-disclosure of adverse…
Protecting People with Mental Disabilities and Impairments against Biomedical Research Abuse[*] By John H. Noble, Jr., Ph.D, The Catholic University of America, Washington, DC, USA Vera Hassner Sharav, MLS, Alliance for Human Research Protection, New York, USA People with mental disabilities and impairments historically have been targeted by biomedical researchers…
WSJ: Debate Over Antidepressants: FDA role in suppressing damaging data Tue, 25 May 2004 How were drug manufacturers able to conceal vital evidence of harmful antidepressant drug effects? The answer is becoming clearer by the day: federal regulators and the psychiatrists who tested these drugs in clinical trials are invested…
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…
Congress & the White House must remedy a prescription for danger – LA Times / CBS News Thu, 1 Apr 2004 For those who missed the CBS evening News broadcast (Tues March 30) about FDA’s suppression of evidence, a video of that powerful report can be viewed online. http://www.cbsnews.com/stories/2004/03/30/eveningnews/main609491.shtml CBS…
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…
Expert FDA Report: SSRI Suicide risk_SF Chronicle / NYT/ NJ Ledger/ AP Fri, 16 Apr 2004 FDA officials have provoked congressional hearings at which they will have to explain, not only why they concealed data linking antidepressants to increased violent and suicidal behavior, and why they covered up a report…
Concealed NIH Review Substantiates Fired Expert’s Concerns – AP Mon, 4 Jul 2005 The Associated Press reports that a 2004 internal report by the National Institutes of Health validates the allegations by Dr. Jonathan Fishbeing, the NIH ethics-safety expert who was fired for reporting unethical and scientifically flawed AIDS resesrch…
