NIH ethics review

NIH ethics review Thu, 15 Jan 2004 There is nothing quite like good investigative journalism to shake public officials from their complacency. An investigative report by David Willman in The Los Angeles Times on Dect 7, 2003, has sent NIH director, Dr. Elias Zirhouni, scrambling to explain why NIH has…

Antidepressant Controversy: Media Conflicts of Interest – New York Times

Antidepressant Controversy: Media Conflicts of Interest – New York Times Thu, 25 Mar 2004 FDA’s advisory warning about antidepressant drugs received wide press coverage nationally. But few in the national media mentioned conflicts of interest as the obstacle to disclosure of evidence showing these drugs’ adverse effects. Among the few…

FDA Asks Antidepressant drug companies to add Cautions on labels

FDA Asks Antidepressant drug companies to add Cautions on labels Mon, 22 Mar 2004 The FDA has “requested” drug companies to put prominent warnings on the labels of 10 antidepressant drugs, “to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the…

FDA Bad Faith – Daniel Troy’s pre-emption defense – Nat’l Law Journal

FDA Bad Faith – Daniel Troy’s pre-emption defense – Nat’l Law Journal Fri, 26 Mar 2004 Federal regulations require drug label warnings if there is “reasonable evidence” of a link between adverse effects and drug action. An article in the National Law Journal shows how s FDA’s chief counsel, Daniel…

Conflicts of Interest policy – New York Times

Conflicts of Interest policy – New York Times Sun, 28 Mar 2004 To: ‘Executive-editor@nytimes’; ‘gcollins@nytimes’; ‘arosenthal@nytimes’; ‘pboffey@nytimes’; ‘lchang@nytimes’; ‘oped@nytimes’ Cc: ‘Daniel Okrent’ ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP) Promoting openness and full disclosure https://ahrp.org FYI Friday’s New York Times included the following Editor’s Note on the paper’s Op Ed page:…

Ex-NIH Director Lifted conflict of interest rules, Now favors limits on Drug-Company Ties – LAT

Ex-NIH Director Lifted conflict of interest rules, Now favors limits on Drug-Company Ties – LAT Sun, 14 Mar 2004 Former Director of the National Institutes of Health, Harold Varmus, MD, appeared before a blue ribbon panel convened by his former agency, ostensibly to shed light on conflict of interest at…

Prescriptions And Profit_CBS News 60 Minutes Tue, 16 Mar 2004

Prescriptions And Profit_CBS News 60 Minutes Tue, 16 Mar 2004 “Americans pay far more for their prescription drugs than citizens of any place on Earth.” That’s because “The United States is the only industrialized country without some form of control on the prices of drugs.” No wonder the U.S. accounts…

Pharma Efforts to Bar Placebo Responders from Trials – WSJ

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…

Antidepressant drug induced Suicides: Evidence of "Iceberg effect" Revealed

Antidepressant drug induced Suicides: Evidence of “Iceberg effect” Revealed Thu, 10 Jun 2004 Canada West reports today: “At least five teenagers in Canada have died, four of suicide, while being treated with the most widely prescribed antidepressants in Canada and at least 100 other children as young as 18 months…

Glaxo chief executive angry over NYS AG lawsuit – Telegraph

Glaxo chief executive angry over NYS AG lawsuit – Telegraph Tue, 8 Jun 2004 The significance of the lawsuit filed by NYS Attorney General, Eliot Spitzer, has infuriated Jean-Pierre Garnier, GlaxoSmithKline’s CEO. As Money.Telegraph (UK) reports (below), the AG suit carries a significance beyond the money sought. “Reputationally, however, the…

FDA Alert: Effexor warnings added for neonatal adverse effects and suicidality risk

FDA Alert: Effexor warnings added for neonatal adverse effects and suicidality risk Tue, 29 Jun 2004 On June 28, the FDA and Wyeth issued a new MedWatch drug Alert to healthcare professionals: “Neonates exposed to Effexor, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late…

New York Times Editorial Gets it Right: When Drug Companies Hide Data

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,…