Medicare Will cover New Treatments But Patients Will be Required to Enroll in Clinical Trials Fri, 5 Nov 2004 Dr. Mark McClellan, Director of Medicare, estimates that of Medicare’s $320 billion budget, “a third of all medical expenditures are for unnecessary or ill-advised treatments.” Medicare’s chief medical officer, Dr. Sean…
Research dispute prompts patient-trials debate_Seattle Times Mon, 19 May 2003 Newhouse News Service reports that the continuing dispute about the ethics and design of a multi-site lung ventilation experiment sponsored by the National Heart, Lung, and Blood Institute (NHLBI) and conducted by the ARDSNetwork on 861 critically ill patients with…
How Did the Vioxx Debacle Happen? USA Today / Lancet Tue, 12 Oct 2004 Dr. Eric Topol of the Cleveland Clinic: “The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public…
Follow the Money / Can the Institute of Medicine Review the FDA? Wed, 6 Apr 2005 A letter to the editor published in Nature Medicine by Dr. Bernard Carroll, a past chairman of the FDA Advisory Committee for Psychotropic Drugs, and past chairman of the Department of Psychiatry at Duke…
Rutherford Files Mental Health Screening Lawsuit_Indiana / Fierce Opposition to TeenScreen Mounts – Pittsburgh Mon, 19 Sep 2005 The Rutherford Institute has just filed a lawsuit in Indiana challenging a school for subjecting a teenager to a mental health screening test – TeenScreen–without her parents’ knowledge or consent. After completing…
The Children’s Hospital of Philadelphia Department of Anesthesiology and Critical Care Medicine Robert M. Nelson, M.D., Ph.D. 34th Street & Civic Center Boulevard, Rm. 1513 Chair, Committees for the Protection of Human Subjects Philadelphia, Pennsylvania 19104-4399 Associate Professor of Anesthesia and Pediatrics (215) 590-9180 Office (267) 426-5035 Fax November 25,…
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…
FDA says it Screened Panelists for Conflicts of Interest Tue, 1 Mar 2005 Bloomberg News reports that the Center for Science in the Public Interest had identified not 10, but 27 panelists on FDA’s advisory panel who had financial ties to drug manufacturers. Last week The New York Times reported…
WSJ: Debate Over Antidepressants: FDA role in suppressing damaging data Tue, 25 May 2004 How were drug manufacturers able to conceal vital evidence of harmful antidepressant drug effects? The answer is becoming clearer by the day: federal regulators and the psychiatrists who tested these drugs in clinical trials are invested…
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…
Will 2 to 5 year old Amer. kids be exposed to Smallpox Vaccine? Israeli Intelligence says “No immediate threat” Sat, 28 Dec 2002 What is the Administration’s final decision regarding the proposed smallpox vaccine trial that would expose 40 children aged 2 to 5 years old to a controversial live…
Pfizer Statements RE: Bextra, Celebrex, Neurontin Shown to be Lies Fri, 08 Apr 2005 The New York Times reports that “as recently as Tuesday [Pfizer] assured Wall Street that sales of Celebrex and Bextra would soon rebound. It was the latest in a string of announcements by the company regarding…
