Sen Grassley to Offer Mandatory Drug Data Registry Bill Fri, 10 Dec 2004 AHRP applauds Senator Chuck Grassley for spearheading legislation that will require pharmaceutical companies to register ALL drug trials and report their results in a public database. Given the record of deception and concealment of adverse data, anything…
Contracts Keep Drug Research Findings Concealed – NY Times Mon, 29 Nov 2004 I. A front page article in the New York Times focuses on academia’s role (culpability) in keeping mum about the unpublished antidepressant clinical trial results. The unnamed focus of the article is the industry-supported American College of…
Govt Prozac study Recommends MANDATORY Screening & Drugs – “Overdosed America”_OpEd NYT Sun, 19 Sep 2004 FDA’s Review of Safety & Efficacy Concerns in Anti-Depressant Use by Children is the subject of a second Congressional hearing by the House Energy & Commerce Subcommittee on Oversight / Investigations on September 23,…
Conflict of Interest: Profits vs Safety Congressional Investigations US Senators Pharmaceutical industry holdings, 2004: http://www.consumerwatchdog.org/resources/SenPharma.pdf Oct 12: How Did the Vioxx Debacle Happen? USA Today / Lancet Oct 4: Op Ed: Psychiatry on the Ropes–WP / Evidence-based Psychiatry Oct 3: BBC PANORAMA TONIGHT – Taken on Trust – 13 years-Medical…
FDA Failed to Enforce Law Requiring Drugmakers to Disclose Test Data – WashPost Tue, 6 Jul 2004 A front page article in The Washington Post reports that the FDA failed to enforce the law that requires drug companies to disclose ALL clinical drug trials and ALL trial findings-whether they’re good…
Forest Labs Admits Concealment of data – Congressional Probe Expands Sat, 26 Jun 2004 New York Times business reporter, Barry Meier, reports, “Forest officials had not told a medical journal about a failed unpublished study in 2002 of Celexa use in children and adolescents, before the journal published an article…
Cong. Hinchey calls for ouster of FDA Counsel Sen. Bingaman & Reed tell FDA: disclose all trial info Thu, 15 Jul 2004 Wish I’d said that: “Having Daniel Troy as chief legal counsel of the FDA, is like placing John Gotti in charge of the Justice Department.” (Tom Woodward, whose…
Tell the Truth About Antidepressants On Drug Labels & in Medical Journals Thu, 16 Sep 2004 An April, 2004 editorial in the New York Times noted: “What seems most astonishing is the skimpy evidence that these drugs work at all in most young patients.” What is astonishing is how the…
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…
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,…
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.
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…
