2 to 5 year old children targeted for Smallpox Vaccine trial_DHHS Sat, 2 Nov 2002 An announcement in the Federal Register, Oct 31, 2002, by the Office of Public Health and Science and Food and Drug Administration calls for public review and comment about proposals to the Secretary of Health…
Will NIH Ban on Consulting Deals with Drug Firms Set an Ethical Example? LAT / NYT Wed, 2 Feb 2005 The Los Angeles Times, whose investigative reports about conflicts of interest at the National Institutes of Health, shook the foundations of NIH by prying open the vaults that contained secret…
Advisory Committee tells FDA: strengthen warnings on SSRI drug labels now Wed, 4 Feb 2004 On February 2, more than 60 families and children from all across America testified at a public FDA advisory committee hearing describing (in 2 minutes) how their children suffered drug-induced harm after being prescribed an…
FDA response to AHRP procedural questions From: Cerny, Igor Sent: Wednesday, January 07, 2004 11:52 AM To: Cc: Patel, Anuja; Laughren, Thomas P Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns Follow Up Flag: Follow up Flag Status: Flagged Dear Ms. Sharav: Thank you for your email of December 1,…
Senate Finance Committee Investigating FDA brain stimulation device approval – WSJ Thu, 19 May 2005 Another major scandal is erupting about FDA’s approval decisions that contradict its medical officer’s safety concerns. The Senate Finance Committee is investigating what led the FDA to suddenly reverse its disapproval of Cyberonics’ brain stimulation…
FDA Commissioner Nominee told Senate He’s Open to Independent Safety Unit / Biogen issues Avonex Warning Fri, 18 Mar 2005 It would be impossible to gain insight into Lester Crawford’s confirmation hearings by the Senate Health, Education, Labor and Pensions committee if one read only one news report. The Los…
Doctors Without Borders: Why you can’t trust medical journals anymore Tue, 13 Apr 2004 Related link: Hear an interview with Shannon Brownlee on NPR at: http://www.npr.org/features/feature.php?wfId=1874563 Doctors Without Borders in the Washington Monthly (excerpt below), looks at the intricate web of collaborating players in medicine who are financially tied one…
Black Box Warnings for Antidepressants – What’s Next? Thu, 16 Sep 2004 NY TIMES Quotations of the Day: A. “I think that we now all believe that there is an increase in suicidal thinking and action that is consistent across all the drugs.” Dr. ROBERT TEMPLE, of the Food and…
Aug 20, 2002 Medical Science Violating Children – 450 healthy children targeted – Redflagsweekly FYI Redflagsweekly is the first online health news service to pick up on a news item provided in yesterday’s AHRP Infomail about a proposed experiment (whose researcher seeks government funding) to be conducted on 450 children…
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 is adamant about transfering $724 billion in taxpayer…
FDA’s Double Standard Re: Advisory Committee Membership Mon, 15 Nov 2004 FDA’s inexplicable actions–the latest being the removal of Dr. Curt Furberg from an FDA advisory committee for alleged "intellectual conflict of interest" – demonstrate hypocracy and intellectual dishonesty. Dr. Furberg independently analyzed the scientific data, concluding: "The result is…
Government Investigations 1990 to August 2001 National Bioethics Advisory Committee Report: ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS, 1998 Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Asssurances (MPA) between January 1990 – June 2000…
