Major Drug Effectiveness Review Found “Little Evidence” that ADHD drugs are safe or effective Tue, 13 Sep 2005 On paper, drug manufacturers MUST demonstrate with scientific evidence that a drug is safe and effective–if they want to gain to gain FDA approval. The burden of proof is on the manufacturer….
Debate: When Is it Ethical / Unethical to Use Placebo? – PLoS Wed, 12 Oct 2005 A debate in PLoS Medicine addresses the question: Should researchers test an experimental treatment against placebo to prove the superiority of the new treatment? The ethical standards for research adopted by the World Medical…
Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS Sun, 26 Dec 2004 A government survey by the U.S. Department of Health and Human Services, confirms that Americans are the most medicated population in the world – 44 percent of Americans had…
GSK Sales Reps told NOT to Divulge Paxil Data / Merck Withdraws Vioxx Thu, 30 Sep 2004 The Associated Press reports: “Merck pulled Vioxx after admitting studies showed the drug raised the risk of heart attack. As recently as August, Merck “strongly” disagreed with studies showing the drug increased heart…
Natrecor found to worsen kidney function, hasten death – NYT Tue, 17 May 2005 Natrecor, a drug approved by the FDA for treating patients with heart failure, is being widely prescribed off label for unapproved uses. The drug is prescribed for so-called “tune-ups” in outpatient clinics – although that use…
FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks Mon, 29 Aug 2005 Related link: FDA Amicus Curiae–Kallas–claims FDA infallibility pre-empts state safety laws (warning: large 1.6 MB file) A federal judge in Utah has asked the FDA to explain its position as it relates…
Failed Drug Treatments for Schizophrenia–Letters to the Editor – NYT Fri, 23 Sep 2005 Letters to the NY Times editor (below) demonstrate the combative reaction of stakeholders in the psychotropic drug industry to the evidence-based overthrow of psychiatry’s treatment recommendations. Psychiatrists who have financial contracts with psychotropic drug manfuacturers, have…
Former FDA Commissioner says FDA lost public trust Mon, 17 Oct 2005 The FDA’s failure to ensure drugs are properly tested in trials designed to detect serious adverse effects, and the agency’s failure to require follow-up post-marketing studies to be reasonably secure in the knowledge that no lethal drugs are unleashed on the public has…
FDA’s Double Standard Re: Advisory Committee Membership Mon, 15 Nov 2004 FDA’s inexplicable actions–the latest being the removal of Dr. Curt Furberg from an FDA advisory committee for alleged "intellectual conflict of interest" – demonstrate hypocracy and intellectual dishonesty. Dr. Furberg independently analyzed the scientific data, concluding: "The result is…
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…
Jeffrey Drazen editor NEJM Turns Activist on Drug Trials Thu, 26 May 2005 Journal editors, one by one are trying to retrieve the integrity of their publications, at last recognizing that the pharamaceutical industry is a corrupting factor in medical research and the information disseminated about medicine. Jeffrey Drazen who…
Doctors On the Take-Engaging in Vairous Dubious Activities for Cash / Stock Options Tue, 16 Aug 2005 A series of current articles in The Wall Street Journal, the Journal of the American Medical Association (JAMA), and the New York Times describe the many questionable non-medical income-producing activities that America¹s physicians…
