Hutch Settles consent Case out of court – Seattle Times Thu, 16 Jan 2003 The Fred Hutchinson Cancer Center has settled a lawsuit that charged the institution with ethical/legal violations in a fatal cancer trial. The case was brought to light in a superb, 5-part, prize winning series by David…
Wyeth Warning Letter Below are images of the warning letter regarding prescribing information for the use of Effexor in children and adolescents. It was sent by Wyeth to health care professionals on August 22, 2003. You may click on each image to see a larger version. Wyeth letter, page 1:…
Congressional Investigations Senate Finance Committee Investigates FDA Aug 4: Sen. Grassley letter (416 K pdf) to 8 drug companies requests list of all antidepressant tests on children (1/1/1990–7/23/2004) Aug 3: Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data Jul 15: Senate Letter to FDA re: disclosure of risks…
Public Comments Re: Smallpox Vaccine Trial on 2 to 5 Year Old Children I wholeheartedly oppose the use of administering a smallpox vaccine to small children in a randomized study. More controls need to be made to ensure the children’s safety in this situation, and there is too great of…
http://www.mysanantonio.com/news/metro/stories/MYSA020305.13A.antidepressants.6d572159.htm Antidepressant warnings make experts nervous Web Posted: 02/03/2005 12:00 AM CST Marina Pisano San Antonio Express-News Even as warning labels about the risk of suicidality in children and teens taking antidepressants are going on medication labels, a new study is showing that American suicide rates have dropped significantly since…
Scientific Misconduct Notices News Stories on Human Research Protection and Commentary by Vera Hassner Sharav April 22, 2002 Scientific misconduct is a big problem undermining the integrity of the scientific literature. Data falsification leads others to erroneous conclusions that may have adverse consequences for patients in clinical research and clinical…
UK Health Dept/ British Prime Minister/ Issue Statement Warning No PAXIl for Children! Tue, 10 Jun 2003 UK GOVERNMENT STATEMENT: Press release: reference 2003/0223 Tuesday 10th June 2003 Related Story: GlaxoSmithKline discloses link to serious undesirable effects in depressed children and adolescents under age 18 SEROXAT MUST NOT BE USED…
Bayer/ Baycol on Trial in Texas_NYT Sat, 1 Mar 2003 Melody Peterson of the New York Times reports that in the first case brought against Bayer involving its anticholesterol drug, Baycol, a senior official of Bayer AG testified in court in Corpus Cristi, Texas. He acknowledged that company officials in…
Doctor’s Misconduct Left Trail of Broken Lives–A Broken Marriage and a ‘Life Destroyed’ – WashPost Mon, 29 Sep 2003 “I basically lost everything. And my kids? Well, who knows what the long-term damage might be.” A riveting, detailed, two part report in the Washington Post (Sunday, September 28) describes a…
Frontline: Dangerous Prescription Fri, 14 Nov 2003 Frontline, of Public Broadcasting System aired an investigative news report on Thursday that focused on the FDA’s systemic failure to protect the public from hazardous drugs. FDA had approved at least 12 dangerous prescription drugs–the “dirty dozen”–that killed people before the FDA ordered…
Schizophrenia drugs increase diabetes risk Fri, 29 Aug 2003 A large scale study by the Veterans Administration corroborates a body of evidence demonstrating that the much touted “improved” newer drugs for the treatment of schizophrenia–Zyprexa, Risperdal, Seroquesl– are precipitating the onset of diabetes at alarming rates– especially among younger patients….
NHLBI director Dr. Lenfant is Retiring Thu, 3 Jul 2003 The retirement of Dr. Claude Lenfant, director of the National Heart, Lung, and Blood Institute (NHLBI) was announced today. Not mentioned in the press release is the heated controversy surrounding two clinical trials sponsored by the NHLBI, conducted by the…
