Pfizer Zoloft Warnings to Canadian Doctors Contrast to US – FDA Caves In to Pharma lobbying Thu, 10 Feb 2005 The FDA has, once again, quietly colluded with industry, compromising the safety of children’s lives to maintain drug manufacturers’ cash flow. After two FDA advisory committee hearings (Feb 2-3 and…
Pfizer Lawsuits: Zoloft / Neurontin Concealed Evidence: Suicide Risk/ Lack of Efficacy Mon, 26 Jul 2004 On July 23, 2004, a citizen’s consumer protection lawsuit was filed against Pfizer Pharmaceuticals for concealment of evidence and deceptive marketing of the antidepressant Zoloft. The California law firm of Baum Hedlund has filed…
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New York Times business reporter, Barry Meier, reports, “Forest officials had not told a medical journal about a failed unpublished study in 2002 of Celexa use in children and adolescents, before the journal published an article…
To: Thomas Insel MD; Tommy Thompson Re: Published NIMH Prozac Trial Report Concealed Suicide Attempts by Teens ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Tel. 212-595-8974 Fax: 212-595-9086 142 West End Ave. Suite 28P New York, NY 10023 Related Link: NIMH Response to AHRP Letter Board of Directors: Vera Hassner Sharav,…
Recent revelations indicate that pharmaceutical companies have selectively reported partial (favorable) clinical trial results from pediatric antidepressant trials and concealed evidence of harm from physicians, other health care professionals, and the public. It is universally agreed in the literature that failure to disclose all trial results compromises physicians’ ability to provide professional care – thereby increasing the likelihood of causing preventable harm. More generally, failure to disclose trial results in scientific publications taints the scientific literature (by rendering it not credible) and, as New York State Attorney General Elliot Spitzer charged recently, constitutes plain and simple fraud.
VIOXX – Merck–MEDCO – a case study Wed, 13 Oct 2004 Vioxx: A case study in how a lethal drug is marketed and dispensed – without MINIMAL safeguards to protect people’s lives. Merck marketed and sold billions of dollars worth of Vioxx through MEDCO–the largest Medicare Pharmacy Benefit Manager (PBM)…
Comments submitted by The Alliance for Human Research Protection Re: Best Pharmaceuticals for Children’s Act of 2002 The National Academy of Sciences Committee of the Institute of Medicine on Clinical Research Involving Children August 18, 2003 Vera Hassner Sharav, President John H. Noble, Jr., Ph.D, Treasurer David Cohen, Ph.D, Secretary…
AHRP has been closely monitoring pediatric research trends since passage of the FDA Modernization Act of 1997. We believe that medications used in children should be thoroughly tested for safety, effectiveness and appropriate dose. But unlike adults who can exercise their autonomous right to informed consent, children who are enrolled in clinical trials are non-consensual human subjects. They should not, therefore, be made to assume the burden of testing possibly toxic drugs whose safety is unknown.
Infomail Archive 2003 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 19, 2003: Eli Lilly Prozac UK Fact Sheet: “Not Recommended” for Children – PMDD Withdrawn in UK Dec 19, 2003: Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Dec 18, 2003:…
References for 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 Agency for Health Care Research & Quality. (1999). Treatment of attention-deficit/hyperactivity disorder: Summary, evidence Report / Technology assessment…
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department and The Henry M. Jackson Foundation for the Advancment of Military Medicine
The cornerstone of public trust in medical research is the integrity of academic institutions and the expectation that universities, which rely on public funding, have a responsibility to serve the public good. Financial conflicts of interest affect millions of American people – those who are subjects of clinical trials testing new drugs and those who are prescribed drugs after their approval.
CONFLICTS OF INTEREST Presented by Vera Hassner Sharav 14th TRI-SERVICE CLINICAL INVESTIGATION SYMPOSIUM Sponsored By THE U.S. ARMY MEDICAL DEPARTMENT And THE HENRY M. JACKSON FOUNDATION FOR THE ADVANCMENT OF MILITARY MEDICINE May 5-7, 2002 The cornerstone of public trust in medical research is the integrity of academic institutions and…
