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…
Charitable Choice: Research Grants–Juvenile Diabetes Research Foundation – National Journal Tue, 8 Mar 2005 The Washington Post reports that conservatives have crafted a “bioethics agenda” on cloning and stem cell research. Such an agendaq determines what research the government will and will not fund. http://www.washingtonpost.com/wp-dyn/articles/A15569-2005Mar7.html Below is an excerpt of…
What’s in a Warning? Antidepressants and Risk of Suicide – FindLaw Thu, 22 Apr 2004 Contrary to the published reports in the peer-reviewed journals, the preponderance of evidence demonstrates that antidepressants pose a greater risk than a benefit for children. *[References below] Informed medical treatment decisions hinge on the decision…
FDA Forced Wyeth to REMOVE Suicide Warning from Effexor Label Wed, 8 Sep 2004 The Wall Street Journal reports that FDA officials forced Wyeth to remove the label warning stating: “In pediatric clinical trials, there were increased reports of hostility and, especially in Major Depressive Disorder, suicide-related adverse events such…
July 08, 2002 Critique: U.S. to Vaccinate 500,000 Workers Against Smallpox 7 Jul 2002 FYI Dr. Meryl Nass, a member of the board of The Alliance for Human Research Protection and a recognized expert on Gulf War Syndrome and the use and consequences of experimental vaccines, raises serious concerns about…
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…
Human Pesticide Experiments “Allowing human experiments, such as those conducted recently in the United Kingdom, to serve as the basis for registering pesticides, is ethically indefensible.” Ken Cook, President Environmental Working Group January 8, 2003 "Should the EPA Accept Human Pesticide Experiments?", testimony by Vera Hassner Sharav before the Committee…
Recent developments in gene transfer research: risk and ethics Mon, 10 Jan 2005 An analysis by Dr. Jonathan Kimmelman, in the British Medical Journal provides an illuminating, clearly articulated discussion about the ethical dilemmas that challenge gene transfer experiments – essentially a kind of human genetic engineering involving somatic cells,…
GlaxoSmithKline CEO: “We had to absorb a number of hits” Mon, 16 Feb 2004 Antidepressant drug safety issues are beginning to have a financial impact. Dow Jones reports: “GlaxoSmithKline PLC said its net income fell 6% in the fourth quarter, hurt by previously announced legal costs related to its anti-inflammatory…
FDA Alert: Effexor warnings added for neonatal adverse effects and suicidality risk Tue, 29 Jun 2004 On June 28, the FDA and Wyeth issued a new MedWatch drug Alert to healthcare professionals: “Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late…
July 26, 2002 2,610 Infants died of preventable hospital-acquired infections – Chicago Tribune FYI President Bush would limit health care liability http://www.nytimes.com/2002/07/26/politics/26BUSH.html . Clearly neither he nor his advisers have considered The Chicago Tribune’s investigative series, Unhealthy Hospitals (excerpt below). This Tribune series should be required reading for members of the various research…
