AIDS Drug Trial report–Slipshod Journalism– NY Times Sat, 23 Jul 2005 Please join our effort to tweak the New York Times to practice what their banner states: “All the News that’s fit to print” That surely means fair and balanced reporting about contentious issues that pit the weak and vulnerable…
FDA Advisory Suicide Risk for Adults on Antidepressants / Advisory Committee Resistant to issue Warnings on ADHD drugs Fri, 1 Jul 2005 Under public and congressional pressure to disclose fully the hazardous effects of widely prescribed drugs, the FDA is beginning to acknowledge the long-denied evidence: psychotropic drugs may INDUCE…
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…
FDA Accepts Adverse Drug Reaction Reports from Consumers Sun, 22 Jun 2003 Doctors report only 1% to 10% of adverse drug reactions experienced by their patients to FDA’s MedWatch service. The FDA has extended an invitation to the public to submit adverse drug reaction reports directly to the agency: http://www.fda.gov/medwatch/report/consumer/consumer.htm…
Commonly recommended Treatments found Worthless Wed, 19 Mar 2003 Independent analyses of the clinical studies upon which widely recommended drug treatments have been based, have now been found to be fatally faulty, and the drugs are deemed worthless. An analysis of 83 studies found that drugs used to treat 90,000…
Pfizer Nears Drug Settlement Sun, 16 Mar 2003 A 7-year lawsuit filed by Dr. David Franklin, the former Harvard fellow turned whistle blower, may be reaching a resolution. The suit accuses Warner Lambert (now Pfizer) of illegally promoting the epilepsy drug, Neurontin, for conditions not approved or tested. His lawsuit…
British Government Issues New Warnings Re: Use of antidepressant drugs for children Tue, 23 Sep 2003 related link: U.K. Government Document – New SSRI Warnings for Children In light of evidence from previously unexamined data from controlled clinical trials, the British Committee on Safety of Medicines (CSM), an arm of…
Medscape Cites AHRP Concerns Re: New Law Mandates More Testing of Drugs in Children Wed, 17 Dec 2003 Medscape Medical News reports about passage of the Pediatric Research Equity Act (PREA) which replaces FDA’s Pediatric Rule. The Pediatric Rule was struck down by a Federal court in Oct. 2002 because…
