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Submitted Testimony of Meryl Nass, MD Mount Desert Island Hospital Bar Harbor, Maine 04609 (207) 288-5082 ext. 220 Senate Subcommittee on Bioterrorism and Public Health Preparedness Hearing: Biodefense: Next Steps Tuesday, February 8, 2005, 10 am SD-430 Dirksen Senate Office Building Thank you for the opportunity to submit this testimony…
AHRP Campaign to Protect Children from Harm Oct 15: FDA Orders Black Box Warnings on Antidepressants labels and Patient Information Guides to Warn about Suicide risk Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical Deception Sep 30: GSK Sales Reps told NOT to Divulge Paxill Data…
April 2003. American Journal of Bioethics. Children in Clinical Research: A Conflict of Moral Values. Vera Hassner Sharav http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf ABSTRACT (attached & below) This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have…
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…
THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…
Children in "Hot Demand" for Clinical Trials May 31, 2002 FYI Rachel Zimmerman of The Wall Street Journal reports about the "frenzy" to recruit children for drug trials. The inclusion of children in drug trials allows pharmaceutical companies to cash in on six month patent exclusivity extensions worth hundreds of millions of dollars….
Circumcision May Offer Powerful 70% HIV Prevention Tue, 5 Jul 2005 A front page report in the Wall Street Journal reveals that a controlled clinical study conducted by French and South African researchers have found that circumciion reduces the risk of transmitting AIDS by 70%. “The circumcision findings were so…
Natrecor found to worsen kidney function, hasten death – NYT Tue, 17 May 2005 Natrecor, a drug approved by the FDA for treating patients with heart failure, is being widely prescribed off label for unapproved uses. The drug is prescribed for so-called “tune-ups” in outpatient clinics – although that use…
SSRI Prescription For Murder? CBS News 48 Hours / Interrogation Methods Can Elicit Confessions From Innocent People Sat, 16 Apr 2005 CBS News is broadcasting the Christopher Pittman story–the 16 year old who was tried for murder as an adult for a crime he committed as a 12 year old…
Drugmakers Go Furthest to Sway Congress: 1,274 Lobbyists – USA Today Tue, 26 Apr 2005 USA Today provides a glimpse into the way the pharmaceutical industry controls health care policy by buying influence at the highest level of government, and underwriting professional and lay healthcare organizations whose spokespersons parrot industry’s…
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…
