FDA administrators "mishandled the initiative through bureaucratic infighting, flawed planning and duplicative work performed by outside contractors." The report estimates that agency administrators wasted $25 million on a computer system that won't be functional before 2009.
What, in addition to $6,000 does the governor of Texas have to gain by issuing an order REQUIRING all Texas 11 year old girls to be vaccinated?
In essence FDA proposals merely change the seating arrangement on the deck of the sinking Titanic. Eli Lilly announced that it intends to seek FDA approval for a long-lasting injectable form of Zyprexa (taken once a month).
The FDA is salivating in expectation of increased funding from the drug industry–ostensibly to speed up the reviewing process for TV ads.
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…
