Eli Lilly’s new Prozac Fact Sheet (image below) sent to UK physicians–but not to US physicians–states that Prozac is NOT RECOMMENDED FOR CHILDREN for any indication. For a larger view, please click on the image.
Drug Tested in Gulf War Is Approved for Troops_NYT Thu, 6 Feb 2003 The New York Times reports that FDA has approved the drug, pyridostigmine bromide for use by the military. The drug had been used experimentally during the Gulf War in 1991. It has been the center of controversy…
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…
FDA Foot Dragging – Three Months After Expert Panel Urged “Black Box” Warnings for Antidepressants, No Action Thu, 23 Dec 2004 Why is the FDA failing to enforce the "Black Box" warnings on SSRI antidepressant drug labels? When questioned by the NJ Star Ledger, Robert Temple, director of the FDA’s…
EPA Proposed Research Rules Leaked Thu Aug 11, 2005 A storm is gathering as EPA’s proposed rules for human pesticide experiments have been made public by the Public Employees for Environmental Responsibility. Stephen Johnson who heads the EPA has delivered what, Eric Olson called, a “slap in the face” to…
Who is a Human Subject? Who has the Right to Informed Consent? March 11, 2002 "The voluntary consent of the human subject is absolutely essential." [Nuremberg Code, 1947] "Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or…
Analysis of 94 OHRP Letters of Determination, July 1, 2000 to January 31, 2001 Research Compliance Note. Thomas Dalglish, JD, PhD * The views expressed in the ‘Research Compliance Note’ below are the personal opinions of the author, do not reflect any official position of the University of Washington, and…
