Even Dr. Robet Temple, FDA Medical Policy Director of the Center for Drug Evaluation & Research dismisses the claimed finidings of a flawed, but highly trumpeted recent SSRI study published in the American Journal of Psychiatry. The study was sponsored by the National Institute of Mental Health.
"When you’re talking deaths in clinical trials, mistakes are not an option," said Dr. Arthur Caplan, a medical ethicist at the University of Pennsylvania. "It’s just an area where we have to have absolute, foolproof reporting in place."
"With conflicts of interest increasingly casting doubt on the credibility of medical research, a leading surgery journal is cracking down on authors who fail to disclose links to industry, threatening to temporarily blacklist them."
New York Times columnist, Paul Krugman, got it right!
The real story behind the crisis at Merck, the Cleveland Clinic, and the medical industrial complex as a whole "is bigger than either the company or the clinic. It’s the story of how growing conflicts of interest may be distorting both medical research and health care in general."
Loss of Trust: Big Drug Makers See Sales Decline With Their Image – NYT Mon, 14 Nov 2005 The lead front page article in today’s New York Times reports: “A poll last month showed that only 9 percent of Americans believed drug companies were generally honest, down from 14 percent…
"Every year, drug companies spend $14 billion to test experimental substances on humans. Across the U.S., the centers that do the testing–and the regulators who watch them–allow scores of human test subjects to be injured or killed."
On behalf of the Alliance for Human Research Protection, or AHRP, I want to thank the members of the Committee, for this opportunity to share with you our understanding of the complex problems presented by medical research involving vulnerable populations, such as prisoners and children. We appreciate your difficult job, and recognize that you will need to exercise courage in your assigned mission, which is to protect prisoners from research abuse and exploitation.
“Courage,” in this context, means the courage to acknowledge uncomfortable facts about current practice and to speak truth to power,
AHRP Speaks Out Dec 12, 2005: Mental Health Screening: A PhRMA Friendly Remedy for Societal Problems. Presentation by Vera Sharav, American Public Health Association Nov 2005: Analysis of S. 1873 – The Biodefense and Pandemic Vaccine and Drug Development Act of 2005 – Karen R. Effrem, MD June 1-3, 2005:…
Bad Medicine: A Gift for Drug Makers–Malpractice Bill Shields Drugmakers Sat, 15 Jan 2005 Knowledgable critics – among them practicing physicians, health care analysts, medical journal editors, journalists, and lay citizens–have reached the conclusion that America’s for-profit health care system – which eats up 16% of the budget–has failed to…
SEC Focusing on Drug Makers Disclosure_ Continuing Medical Ed Changes Tue, 28 Sep 2004 Evidence showing that drug manufacturers and the FDA concealed negative clinical trial data and deceived physicians, consumers, and shareholders about failure to demonstrate the safety and effectiveness of SSRI antidepressant drugs has caught the interest of…
Govt Prozac study Recommends MANDATORY Screening & Drugs – “Overdosed America”_OpEd NYT Sun, 19 Sep 2004 FDA’s Review of Safety & Efficacy Concerns in Anti-Depressant Use by Children is the subject of a second Congressional hearing by the House Energy & Commerce Subcommittee on Oversight / Investigations on September 23,…
FDA’s Waiting Game Exposes Children to Preventable Risks Comments by Vera Hassner Sharav President The Alliance for Human Research Protection Submitted to FDA Advisory Committee Psychopharmacological Drugs Advisory Committee and Pediatric Subcommittee Drugs Advisory Committee September 13-14, 2004 Meeting RE: Suicidality Associated with Antidepressant Drug Treatment The Alliance for Human…
