NIH ethics review Thu, 15 Jan 2004 There is nothing quite like good investigative journalism to shake public officials from their complacency. An investigative report by David Willman in The Los Angeles Times on Dect 7, 2003, has sent NIH director, Dr. Elias Zirhouni, scrambling to explain why NIH has…
Investigative Press Reports Aug. 7, 2002: Los Angeles Times. UC Seeks to Ease Curbs on Patient Research, by Charles Ornstein and Rebecca Trounson http://www.latimes.com/features/health/medicine/la-me-uc7aug07.story?coll=la%2Dhealth%2Dmedicine SPECIAL REPORT : Experiments on Humans, San Francisco Chronicle August 4, 2002: Business of clinical trials soars, but risks unknown Medical studies give new hope to…
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…
Critics of NIH Studies Prompt Senate Hearing – WashPost Mon, 19 Jan 2004 Accountability is a controversial concept for officials at the National Institutes of Health (NIH). Dr. Elias Zirhouni, director of NIH, is scrambling to explain recent revelations of impropriety: First, the agency approved taxpayer money for highly questionable…
Protecting Human Subjects in Research: Are Current Safeguards Adequate? AHRP Testimony submitted to Congressional Committee April 23, 2002 Vera Hassner Sharav, President, and John H. Noble, Jr., Ph.D., steering committee member, The Alliance for Human Research Protection (AHRP), before the Subcommittee on Public Health, Committee on Health, Education, Labor, &…
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…
August 7, 2002 University of California Seeks to Ease Curbs on Patient Protection in Research – LA Times FYI Thanks to a series of articles, in the San Francisco Chronicle and Los Angeles Times, the public has been made aware about the back-door efforts to pass a bill in California…
Columbia Journalism Review–The Complicity of the Media in Drug Marketing Wed, 27 Jul 2005 An excellent article in the Columbia Journalism Review examines pharmaceutical industry hype and the media’s role in helping that industry create false impressions about the safety and benefits of newly marketed drugs: “stories trumpeting new drugs…
NIH: Public Servant or Private Marketer? NIH Seeks Outside Inquiry of Alzheimer’s researcher conflicts of interest – LAT Mon, 31 Jan 2005 A year after the Los Angeles Times published its first an in-depth investigative report documenting in detail evidence of major conflicts of interest by top scientists at the…
August 26, 2002 OHRP Retreats from Providing Public Info re: Compliance Activities FYI A newly posted announcement by the Office of Human Research Protection (OHRP), dated July 15, rescinds the agency’s announced policy of making public the content of its letters of determination following the agency’s investigation of compliance /…
Guidant Didn’t Disclose a Flaw in Defibrillator for 3 Years_NYT / FDA Wrong on Crestor Safety Tue, 24 May 2005 The New York Times reports that the maker a a heart defirillator knew for 3 years about a malfunction and failed to inform physicians about It because the company “had…
NIH Panel Recommendations Fail to Resolve Conflicts of Interest Date: Fri, 7 May 2004 Following the disclosure by the Los Angeles Times (December 2003) that “NIH officials now allow more than 94% of the agency’s top-paid employees to keep their consulting income confidential,” Congress demanded full disclosure and an overhaul…
