NHLBI director Dr. Lenfant is Retiring Thu, 3 Jul 2003 The retirement of Dr. Claude Lenfant, director of the National Heart, Lung, and Blood Institute (NHLBI) was announced today. Not mentioned in the press release is the heated controversy surrounding two clinical trials sponsored by the NHLBI, conducted by the…
US Research Community May Take Lessons in Medical Ethics from Cambodian Prostitutes Thu, 12 Aug 2004 The US medical research community may have to take lessons in medical ethics from Cambodian prostitutes. A clinical trial to test a drug used to treat HIV, Viread, for the prevention of AIDS, was…
Someone Tell Brooke Shields the Truth!! Mon, 4 Jul 2005 On this American independence day, thousands of families strive for drug free schools–and they’re not worrying about illegal drugs, their main concern is coercive prescribed amphetamines and other mind-altering psychotropic drugs. Other than the critical reaction of actor Tom Cruise,…
Ethical Violations / Investigations Today Congressional Investigations Office of Human Research Protections (OHRP) Letters of Determination: http://ohrp.osophs.dhhs.gov/detrm_letrs/lindex.htm Office of Protection from Research Risks* (OPRR) List of Compliance Oversight Investigations Resulting in Restrictions or Actions to federally licensed Institutions between 1990 – 2000. *Reorganized in 2000 as OHRP Mar 30: AHRP…
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….
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children Being proactive is generally a good idea. But in the absence of a definitive outbreak it is difficult to justify exposing pediatric patients to potential risks such as neurologic complications which may not show up for years….
Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that…
Research dispute prompts patient-trials debate_Seattle Times Mon, 19 May 2003 Newhouse News Service reports that the continuing dispute about the ethics and design of a multi-site lung ventilation experiment sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and conducted by the ARDSNetwork on 861 critically ill patients with…
Soldier vaccinated with anthrax / smallpox died shortly from pneumonia: Army coverup- UPI Sat, 9 Aug 2003 It would appear that suppressing negative results – in this case, probably death from pneumonia that followed inoculation with two experimental vaccines – anthrax and smallpox – is the norm and practice both…
Medicare Will cover New Treatments But Patients Will be Required to Enroll in Clinical Trials Fri, 5 Nov 2004 Dr. Mark McClellan, Director of Medicare, estimates that of Medicare’s $320 billion budget, “a third of all medical expenditures are for unnecessary or ill-advised treatments.” Medicare’s chief medical officer, Dr. Sean…
Wed, 04 May 2005 Researchers Tested AIDS Drugs on Children, Associated Press On March 10, 2004, The Alliance for Human Research Protection filed a complaint with the FDA and the federal Office of Human Research Protection about a series of AIDS drug experiments conducted on New York City children in…
World Medical Association DECLARATION OF HELSINKI Â Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended by the 29th WMA General Assembly, Tokyo, Japan, October 1975; 35th WMA General Assembly, Venice, Italy, October 1983; 41st WMA General Assembly, Hong…
