US Research Community May Take Lessons in Medical Ethics from Cambodian Prostitutes

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…

Ethical Violations and Investigations Today

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 – AHRP Infomail, May 31, 2002

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, Pg 2

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….

AHRP in the News

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

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

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

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…

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AIDS Drug Experiments on Foster Care Children – A National Scandal

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…

Declaration of Helsinki

World Medical Association DECLARATION OF HELSINKI  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…

Pilots/ Children prescribed addictive stimulant drugs

Pilots/ Children prescribed addictive stimulant drugs – “go pills” / “no go pills” – Christian Sci Monitor Fri, 20 Sep 2002 The Christian Science Monitor (below) reveals that performance-enhancing drug use by US military personnel is likely to escalate. To stay awake during long range bombing missions, U.S. pilots use…