National Assoc School Psychologists Communiqué Re: Paxil, SSRIs Thu, 18 Dec 2003 In a Communiqué to its membership about regulatory action to protect children from the hazards of Paxil and other antidepressants, The National Association of School Psychologists acknowledges the leading role played by The Alliance for Human Research Protection…
New York Times Editorial Gets it Right: When Drug Companies Hide Data Sun, 6 Jun 2004 At last, the New York Times editorial board has come to recognize that: “drug companies should be forced to make public the results of all of their clinical trials the moment they are completed,…
Advisory Committee tells FDA: strengthen warnings on SSRI drug labels now Wed, 4 Feb 2004 On February 2, more than 60 families and children from all across America testified at a public FDA advisory committee hearing describing (in 2 minutes) how their children suffered drug-induced harm after being prescribed an…
Additional information as of late Wed Oct 19: Although I was assured that attendance for a presentation by Dr. David Healy (at Columbia University School of Public Health on Oct. 20 at 12:30) would be open to the public, a problem seems to have emerged after an AHRP Infomail about…
Data from Unpublished Trials Suggest that Most SSRI Antidepressant Drugs Unsuitable for Children Wed, 21 Apr 2004 An independent analysis in next week’s The Lancet compares the published and unpublished data of pediatric SSRI antidepressant clinical trial data, finding the published reports not to be evidence-based. “In a global medical…
Bayh-Dole Act: The Law of Unintended Consequences – Fortune Sun, 25 Sep 2005 The author of this Infomail is Dianne N. Irving, M.A., Ph.D. Revisiting the Bayh-Dole Act (1980): Spawned Big Biotech, Now Has Opposite Debilitating Effects Today’s specter of harmful and inordinately priced drugs pressed on legislators and the…
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
British Medical Journal: Something is rotten at the heart of FDA / Glaxo faces class action suit Sun, 5 Dec 2004 “Something is rotten at the heart of the FDA.” That’s the opening of an editorial in the British Medical Journal. [1] Indeed, there is something rotten at the heart…
Unreported Paxil suicides: company abandons “No Addiction” claim Sat, 10 May 2003 GlaxoSmithKline, Britain’s biggest pharmaceutical company will change the label in the UK to reflect the severe withdrawal that its antidepressant drug, Seroxat (Paxil in US) generates in many patients. In Britain, the package label will no longer claim…
Not-So-Public-Relations: Drug Industry & Bioethics – is it casuistry or sophistry? Fri, 19 Dec 2003 Carl Elliott is a clear eyed academic who teaches bioethics at the University of Minnesota . He is currently a visiting associate professor at School of Social Sciences at the Institute for Advanced Study at Princeton….
Pharma Efforts to Bar Placebo Responders from Trials – WSJ Fri, 25 Jun 2004 A clinical trial report in The Lancet debunks the value of Aricept, a popular drug prescribed for Alzheimer’s patients. The findings of a three-year placebo controlled trial show that: “Although the patients taking the drug did…
Time for a Drug Test Registry_Marcia Angell_Why NIH is Not Up to the Task Fri, 13 Aug 2004 The uncovering of concealed, unpublished evidence showing that children suffered harm in antidepressant drug trials, has led to a rude public awakening. Selective reporting of clinical trial data has become “standard practice”…
