Fast growing business: Unethical clinical trials in India – Asia Times

Fast growing business: Unethical clinical trials in India – Asia Times Tue, 27 Jul 2004 Asia Times reports: “India increasingly emerges as a preferred destination for outsourcing clinical trials – testing of new drugs on humans – the country may also be heading toward providing the greatest source of human…

Children in Clinical Research: A Conflict of Moral Values

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…

US Gov Pesticide Exposure Experiments: Target Children–$970 per child – Wash Post

US Gov Pesticide Exposure Experiments: Target Children–$970 per child – Wash Post Wed, 3 Nov 2004 The Washington Post reports (below) that the Environmental Protection Agency (EPA) announced plans to enroll 60 young children in Duval County, Florida – infants to age 3 – exposing them to pesticides to study…

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…

GSK Sales Reps told NOT to Divulge Paxil Data / Merck Withdraws Vioxx

GSK Sales Reps told NOT to Divulge Paxil Data / Merck Withdraws Vioxx Thu, 30 Sep 2004 The Associated Press reports: “Merck pulled Vioxx after admitting studies showed the drug raised the risk of heart attack. As recently as August, Merck “strongly” disagreed with studies showing the drug increased heart…

NIH ethics review

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…

OHRP Compliance Letters

ETHICAL AND POLICY ISSUES IN RESEARCH INVOLVING HUMAN PARTICIPANTS National Bioethics Advisory Commitee (NBAC) Final Report, 2001 Exhibit 3.1: Office of Protection from Research Risks (OPRR) Compliance Oversight Investigations Resulting in Restrictions/Actions to Institutions that have Multiple Project Assurances (MPA) between January 1990 – June 2000 Year, Institution and Action…

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Eugenics: the California connection to Nazi policies

Eugenics: the California connection to Nazi policies_SF Chronicle Mon, 10 Nov 2003 On Sunday, Nov 9, the San Francisco Chronicle published an extraordinary, most informative article by Edwin Black, that sheds light on the role played by the American eugenics movement in the Nazi extermination policy. Eugenics is a pseudoscience…

Government Investigations, 1990 – 2001

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…