FDA response to AHRP procedural questions From: Cerny, Igor Sent: Wednesday, January 07, 2004 11:52 AM To: Cc: Patel, Anuja; Laughren, Thomas P Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns Follow Up Flag: Follow up Flag Status: Flagged Dear Ms. Sharav: Thank you for your email of December 1,…
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…
Accutane Suicide Controversy–small study finds depression reduced Tue, 17 May 2005 Accutane–a drug prescribed for acne has been linked to suicide and birth defects–it carries bold warnings about birth defects. A small non-blinded study finding is being touted by Hoffman-La Roche, manufacturer of Accutane. The study found the drug did…
’91 Merck Memo Warned of Mercury in Baby Vaccines – LAT Tue, 8 Feb 2005 The Los Angeles Times reports that a 1991 internal Merck memo obtained from a whistleblower by James Moody, a Washington lawyer who works with parent groups on vaccine safety issues, provides the “first hard evidence…
The Crawford Resignation Mystery Sat, 24 Sep 2005 Merrill Goozner of Center for Science in the Public Interest provides insight into what may lie behind the sudden resignation of FDA Commissioner, Lester Crawford. Goozner surggests, “One possible clue to the administration’s thinking comes from the appointment of Andrew von Eschenbach,…
Merck / Johnson & Johnson/ Lilly-Zyprexa: $690 Million settlement / a Flowering of Diabetes Drugs Fri, 10 Jun 2005 A cluster of news reports about three pillars of the pharmaceutical industry– Merck, Eli Lilly, and Johnson & Johnson–leave no doubt that this industry has shown its disregard for the welfare…
Eli Lilly Prozac Documents: What do They Reveal? Thu, 27 Jan 2005 A report in the BMJ (formerly the British Medical Journal) that relied on internal Eli Lilly documents to challenge Lilly’s claims about the safety of Prozac has stirred a prickly hornet’s nest. [1] The documents show, among other…
Efforts to Expand Emergency Exception from Informed Consent Thu, 6 Oct 2005 The following announcement posted to the IRB Forum by Dr. Robert Nelson, a KOL (key opinion leader) within the close-knit IRB community– who serve as gatekeepers of human research –demosntrates that the culture of secrecy is entrenched in…
US Preventive Services Task Force: No evidence that screening for suicide reduces suicide Fri, 21 May 2004 The U.S. Preventive Services Task Force (USPSTF) issued its findings and recommendation against screening for suicide. The USPSTF findings corroborate those of the Canadian PSTF. “USPSTF found no evidence that screening for suicide…
Meta-Analysis: Efficacy & Safety of Antidepressants for Children – Brit Medical Journal Sat, 10 Apr 2004 As news of skyrocketing prescribing of antidepressants for children–especially in preschool children–hit the news waves around the world, a major meta-analysis of the 5 published pediatric antidepressant studies was published in the British Medical…
Forbes: Face of The Year: David Graham Mon, 13 Dec 2004 Â Forbes magazine has named Dr. David Graham the Face of the Year’ for his “steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses.” Dr. Graham took a courageous stand as a responsible…
Daniel Troy Legacy: Public Virtually Defenseless against Unsafe Drugs Thu, 18 Nov 2004 The Associated Press reports that at a Congressional hearing today, Dr. David Graham a drug safety expert at the FDA told the Senate Finance Committee that the public is “virtually defenseless” if another medication such as Vioxx…
