NIH Expert on Safe Drug Research Seeks Whistleblower Protection

NIH Expert on Safe Drug Research Seeks Whistleblower Protection Tue, 14 Dec 2004 In the wake of the Associated Press investigative report about unethical NIH-sponsored AIDS research involving infants and pregranant women Africa, and charges of misconduct by high officials at the National Institutes of Health (NIH), Senate Finance Committee…

Stealth Merger: Drug Companies and Medical Research at NIH – LAT

Stealth Merger: Drug Companies and Medical Research at NIH – LAT Sun, 7 Dec 2003 Los Angeles Times reporter, David Willman, who twice won the Pulitzer Prize (1994, 2001) has once again demonstrated what fine investigative journalism is about. His investigative series in 2000 put the spotlight on conflicts of…

Best Pharmaceuticals for Children Act of 2002


Comments submitted by The Alliance for Human Research Protection
to The National Academy of Sciences
Committee of the Institute of Medicine on Clinical Research Involving Children

AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.

Brainstorm to Breakthrough: A Surgical Procedure is Born – NYT

Brainstorm to Breakthrough: A Surgical Procedure is Born – NYT Mon, 4 Aug 2003 Two contrasting reports about experimental surgical procedures: The New York Times reports about a breakthrough surgical procedure to lengthen the intestine in babies born with an intestine so short it is dysfunctional and they are at…

Internal Documents: Bayer Knew of Baycol Dangers — NYT

Internal Documents: Bayer Knew of Baycol Dangers _NYT Sun, 23 Feb 2003 The New York Times reports that internal company documents show that Bayer Pharmaceuticals continued to sell the lethal anti-cholesterol drug, Baycol, despite knowledge that it caused rhabdomyolysis, which causes muscle cells to break down and their contents to…

References: Impact of FDA inclusion of children as test subjects

References for 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 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…

Article

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974               142 West End Ave Suite 28P               FAX: 212-595-9086 New York, NY 10023 www.ahrp.org December 5, 2002 Mr. Edward Swindell Acting Associate General Counsel for Ethics Office of General Counsel, Ethics Division Department of Health and Human Services 200 Independence Ave. SW…