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Time for a Drug Test Registry_Marcia Angell_Why NIH is Not Up to the Task Fri, 13 Aug 2004 The uncovering of concealed, unpublished evidence showing that children suffered harm in antidepressant drug trials, has led to a rude public awakening.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”…
FDA May Require Longer Studies Before Approving Psych Drugs – WSJ Tue, 18 Oct 2005 The Wall Street Journal reports that the FDA has sent out feelers to drug manufacturers to provide “longer-term efficacy data” for psychotropic drugs. This comes after a mountain of evidence shows placebo “works” just as…
Doctors Without Borders: Why you can’t trust medical journals anymore Tue, 13 Apr 2004 Related link: Hear an interview with Shannon Brownlee on NPR at: http://www.npr.org/features/feature.php?wfId=1874563 Doctors Without Borders in the Washington Monthly (excerpt below), looks at the intricate web of collaborating players in medicine who are financially tied one…
Despite Vow, Drug Makers Still Wtihhold Data – NYT letters Thu, 9 Jun 2005 An important article by Alex Berenson in The New York Times, “Despite Vow, Drug Makers Still Withhold Data,” corroborated the untrustworthiness of drug manufacturers. Their public pronouncements and promises to fully disclose their clinical trial data-including…
September 3, 2002 Columbine shooting victim sues Solvay Pharmaceuticals – Insight Magazine FYI Insight Magazine reporter, Kelly Patricia O’Meara, reports in (below) that 19- year old Mark Taylor, a victim of the shooting spree at Columbine high school in 1999, spent nearly two months in the hospital plus 3 years…
Paxil induced suicides in US quantified_Glaxo Faces criminal action in UK over “suicide” pills_Times Mon, 7 Jun Law enforcement is finally catching up with drug companies who, for years, concealed evidence of a drug-related suicide risk for some children and adults who take an antidepressant. The law requires the companies…
