AIDS Drug Trial report–Slipshod Journalism– NY Times Sat, 23 Jul 2005 Please join our effort to tweak the New York Times to practice what their banner states: “All the News that’s fit to print” That surely means fair and balanced reporting about contentious issues that pit the weak and vulnerable…
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…
What Parents Aren’t Being told about their Kids Antidepressants – A Suicide Side-Effect? – SF Chronicle Sat, 10 Jan 2004 An in-depth article in The San Francisco Chronicle reveals how the hidden hazards of SSRIs put adolescents’ lives in danger. For one 16 year old teenager, Paxil posed greater risks…
THE CONSTANT GARDENER–John le Carre’s novel about Big Pharma gets rave reviews Sat, 3 Sep 2005 Constant Gardener, the movie based on the novel by John le Carre, about the pharmaceutical industry’s immoral and even criminal activities, opened nationwide. It has already received rave reviews. Below are two reviews…
Recycled drugs: failed antidepressants– Stratera marketed for ADHD; Cymbalta for incontinence Mon, 26 Apr 2004 A front page article in The Wall Street Journal (excerpt below) provides a roadmap of failed Eli Lilly drugs which the company repackaged for a different condition than the one for which the drugs had…
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…
