Drug Companies Move Trials Outside the US Tue, 17 May 2005 Unless the FDA cracks down by enforcing safety and scientific standards in clinical trials, the drug industry is moving its drug trials out of any regulatory oversight. USA Today reports that 50% of trials sponsored by Wyeth Pharmaceuticals were…
Lilly duloxetine drug trial–19 Quit after a suicide – Philadelphia Inquirer Fri, 13 Feb 2004 19-year old Teri Johnson’s suicide occurred one week after an FDA advisory committee had urged the FDA to issue warnings about prescribing antidepressant drugs for children under 18 because of an increased risk in suicide….
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…
Credibility Crisis:Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA Thu, 16 Dec 2004 A credibility crisis in medical research is smoldering: like the Enron accounting scandal, the prescription-drug debacle is a matter of systemic corruption, including gross and widespread failure by the regulatory process. Unlike…
“Drug Companies Should Make Their Studies Public” NYT Wed, 13 Aug 2003 Concealed and inaccessible research findings are undermining the integrity of medicine, the advancement of scientific knowledge, and most importantly, secrecy is putting people’s lives in jeopardy because prescribing doctors are ignorant about adverse – even lethal – drug…
THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH Vera Hassner Sharav Published in ETHICAL HUMAN SCIENCES & SERVICES Summer 2003, vol. 5 pp. 83-108 Abstract This paper argues that contrary to the claims made by the research stakeholders in industry, academia and government, the…
 THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) https://ahrp.org 142 West End Ave. Suite 28P New York, NY 10023 Testimony by The Alliance for Human Research Protection Committee on Ways and Means Hearing on Protections for Foster Children Enrolled in Clinical Trials May 18, 2005 On March 10, 2004, The ALLIANCE…
Suicide in Psych Drug Trials: FDA Orwelian doublespeak – Insight Magazine Date: Mon, 14 Oct 2002 Insight Magazine’s interview with Dr. Thomas Laughren, team leader for the neuropharmachological drug-products division of the FDA, shows that FDA was caught off guard when Dr. Arif Khan independently analyzed FDA’s data revealing that…
Cognititve Therapy Halves Risk of Second Suicide Attempt – JAMA Tue, 6 Sep 2005 A study tested the effect of cognitive therapy in reducing the risk of a second suicide attempt by following 120 people who had attempted suicide. They were followed for 18 months–far longer than drug trials. According…
Antidepressant Use in Children Soars Despite Efficacy Doubts – Washington Post Mon, 19 Apr 2004 A front page article by Shankar Vedantam in The Washington Post examines the soaring increase in the antidepressant drug prescriptions for children, noting: “The explosion in antidepressant use occurred even though the vast majority of…
Foster children AIDS Drug-Vaccine Experiments-Editorial – OpEd Sun, 22 May 2005 An editorial in the Toledo Blade, “Pediatric Shame,” expresses the moral indignation of the community upon learning that prestigious medical research Institutions nationwide exploited the vulnerability of children in foster care to test experimental AIDS drugs and vaccines: “in…
Asthma Drug trial Halted -Health Risk Are Suspected Mon, 17 Mar 2003 A spate of recent articles have shown that pharmaceutical companies suppress the publication of negative findings about their products. However, that is not the only way these companies keep physicians and patients uninformed about adverse drug effects. Another…
