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…
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…
Dr. Carl Elliott's insightful essay in SLATE:: Why do drug companies want to give money to bioethicists in the first place? In the public relations business, this approach is called "third-party strategy."
AHRP Correspondence with Government Agencies related link: FDA response to AHRP procedural questions (FDA sham conflicts of interest policy) FDA re: supression of SSRI evidence ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) 142 West End Ave, Suite 28P New York, NY 10023 https://ahrp.org Tel: 212-595-8974 e-mail: October 29, 2003 To: Thomas…
A growing Crisis: Aggressive Marketing of drugs for children_Lou Dobbs-CNN Fri, 3 Oct 2003 CNN’s anchor Lou Dobbs, an astute business journalist whose program Lou Dobbs Tonight on CNN examines politics, the economy and a broad range of issues that affect the quality of life and standard of living of…
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.
Debate Resumes on the Safety of Depression’s Wonder Drugs – NYT Thu, 7 Aug 2003 After a decade of lies, deception, and cover-up of evidence linking antidepression drugs – such as, Prozac, Paxil, Zoloft – to acts of suicide in previously non-suicidal people – children and adults, some of who…
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:…
Rate of Preschool Kids Prescribed Antidepressants Skyrockets – Cong Investigates FDA Fri, 2 Apr 2004 A new survey by Express Scripts found the rate at which American children are prescribed antidepressants almost doubled (49%) in 5 years. The steepest unfathomable, medically unsupportable, increase–64%–was among preschool children. This is evidence of…
June 18, 2003. GlaxoSmithKline, manufacturer of Paroxetine (Seroxat, Paxil) issued a letter addressed to British Healthcare Professionals, disclosing that the drug was found be linked to serious undesirable effects in depressed children and adolescents under age 18. Below is an excerpt followed by the original letters: UNDESIRABLE EFFECTS Adverse events…
Toxicologist Blames Prozac for Wife’s Suicide – UK Fri, 27 Jun 2003 News reports from the UK are awash with cases of drug-induced violent suicidal behavior by patients taking Prozac, Paxil and the other antidepressant drugs in their class–i.e., selective serotonin reuptake inhibitors. A coroner’s inquest of the suicide by…
