Two Court Rulings Reject Pfizer-FDA Preemption Claim in Zoloft “failure to warn” cases Thu, 21 Jul 2005 In a stunning federal court order JAMES M. ROSENBAUM, US Chief District Judge in Minnesota, overturned FDA-supported pre-emption arguments in their entirety! “The FDA has no authority to declare, ipse dixit, that a…
Sen Domenici Blasts NIH doctors calling them “pigs” – The Hill Thu, 18 Mar 2004 The shameful revelations of insatiable greed among medical researchers at the National Institutes of Health has disgusted Sen. Pete Domenici, one of the strongest supporters of medical research. “I hate to say it, but the…
ALLIANCE FOR HUMAN RESEARCH PROTECTION Homepage 142 West End Ave. Suite 28P New York, NY 10023 March 10, 2004 Dr. Michael Carome Chief of Compliance Office of Human Research Protections David Horowitz Director, Office of Compliance Food & Drug Administration Dept. of Health and Human Services cc: Dr. Bernard Schwetz,…
Tue, 30 Nov 2004 Tonight the BBC- 2 is airing an investigative report about a series of drug experiments that were conducted on infants and children who were under the guardianship of the New York City Agency for Children’s Services (ACS), and living at Incarnation Children’s Center, a foster care…
RE: Phase I Drug trials used foster children in violation of 45 CFR 46.409 and 21 CFR 50.56
The Alliance for Human Research Protection (AHRP) has reason to believe that federal regulations for the protection of children as research subjects have been seriously violated in federally funded HIV research.
We have learned that a series of Phase I and Phase II drug experiments were conducted on infants and children who were under the guardianship of the New York City Agency for Children’s Services (ACS), and living at Incarnation Children’s Center, a foster care facility under contract with ACS.
Ethics Policy Announced for NIH Officials – LAT Tue, 2 Mar 2004 This is a case demonstrating the power of the press ( the “fourth estate”) in its most important role providing a check on the abuse of government power. An investigative report by David Willman, Pulitzer Prize winning journalist…
20% volunteers drop out after suicide in Eli Lilly’s duloxetine trial Thu, 12 Feb 2004 The Associated Press reports that nearly a fifth of the volunteers testing Eli Lilly’s antidepressant drug, duloxetine, dropped out after Traci Johnson, a 19-year old student committed suicide at a company laboratory. “Three participants in…
Healthy 19 year old volunteer suicides at Eli Lilly laboratory Tue, 10 Feb 2004 The Indianapolis Star reports (below) that Traci Johnson, a 19 year old healthy volunteer, one of 25 local paid volunteers committed suicide by hanging while testing Lilly’s drug, Duloxetine, at Lilly’s Laboratory for Clinical Research. Duloxetine…
Failed Paxil drug tests in children concealed – Guardian UK Thu, 5 Feb 2004 The Guardian (UK) reports (below) that BBC Panorama had obtained secret 1998 documents from SmithKline Beecham (now GlaxoSmithKline, GSK) showing that the company deliberately concealed the failure of Seroxat / Paxil to demonstrate a benefit for…
Researchers Chastise Am J Psychiatry Over Skewed Celexa Study Thu, 31 Mar 2005 A letter by eight medical scientists (most from India, possibly all psychiatrists) have seriously challenged the scientific validity of an article published in the American Journal of Psychiatry. The lead author of the challenged study is one…
TIME – Medicating Young Minds with Mood / Behavior Altering Drugs Sat, 1 Nov 2003 A TIME magazine cover story (excerpt below) looks at the inordinate popularity of prescribing mood altering psychotropic drugs for children begins to raise troubling questions about the specter of doing long-term harm to children. Doctors…
AHRP Press Briefing Scientists Will Analyze SSRI Data – Families Will Tell Their Tragedies THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave. Suite 28P New York, NY 10023 January 27, 2004 Contact: Vera Hassner Sharav President, AHRP Tel. No: 212-595-8974 E-mail: Contact: Lisa Van Syckel Family Liaison…
