Who is a Human Subject? Who has the Right to Informed Consent? March 11, 2002 "The voluntary consent of the human subject is absolutely essential." [Nuremberg Code, 1947] "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or…
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…
Forbes: Judgment Day for the FDA, Pfizer Wed, 9 Feb 2005 On Feb. 16-18 COX-2 Inhibitor Safety Issues will be the focus of an FDA Advisory Committee and (simultaneously) the European Medicines Agency (EMA). The entire drug industry will be watching with bated breath. Which causal explanation will be offered…
FDA’s Lethal Weakness Requires More than Committees Sun, 7 Nov 2004 Bloomberg News reports that New York State Attorney General Eliot Spitzer requested information from Pfizer about the promotion of some of its drugs for unapproved uses – the recalled diabetes drug, Rezulin and the antidepressant, Zoloft were named. In…
Antidepressant Controversy: Media Conflicts of Interest – New York Times Thu, 25 Mar 2004 FDA’s advisory warning about antidepressant drugs received wide press coverage nationally. But few in the national media mentioned conflicts of interest as the obstacle to disclosure of evidence showing these drugs’ adverse effects. Among the few…
IOM Committee Considers Prison Research Sun, 24 Jul 2005 Today¹s New York Times Magazine cover story, Planet of the Retired Chimpanzees By CHARLES SIEBERT, reports that chimpanzees who have served as subjects in biomedical research can look forward to being set free in one of 12 specially built chimp sanctuaries…
UK reports the FDA Conceals Vital Data on Prescription Drugs – Independent Sun, 12 Jun 2005 The entire world has trusted the FDA to ensure that only safe and effective drugs are approved for marketing–other agencies, lacking the necessary resources often followed FDA’s lead. However, such deferrence is no longer…
Beware of Avian Flu Hoax – Senate HELP Committee OK’s bill to Shield Drug / Vaccine Mfg Tue, 25 Oct 2005 Serious questions are being raised by physicians and knowledgable critics about the government’s bullying tactics to promote the vaccine business. The scare tactics used to promote mass vaccination against…
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…
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) August 21, 2002 Comments Re: DHHS Notice of Proposed Recommendation Regarding Support of Research Protocol: "Precursors to Diabetes in Japanese American Youth" Grant Number I R01 DK59234-01 The proposed experiment would involve 450 children healthy children, aged 8-10 years old, 300 of Japanese ancestry…
FDA Public Health Advisory: SSRI-Suicide link in adults Wed, 20 Jul 2005 The American Medical Association is attempting to trivialize the hazards of prescribing SSRIs to children, urging physicians not to allow the evidence to interfere with their prescribing habits. See: http://www.ama-assn.org/ama/pub/category/print/15186.html The AMA has done the public a disservice…
Antidepressants Pregnancy Risk: Babies Adversely Affected Sat, 5 Feb 2005 Thanks to the BBC 3-part Panorama series (beginning October 2002), it is no longer a secret that coming off SSRI antidepressants can cause serious symptoms of withdrawal in some users. Christopher Pittman is on trial for killing his grandparents while…
