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…
Antidepressant drugs Used as Placebos! Fri, 10 Oct 2003 Increased use of antidepressant drugs during the 1990s, has increased national spending on antidepressant drugs by a walloping 600%! Dr. Jay Pomerantz of Harvard writes, “inappropriate use of antidepressant drugs may lead to a deterioration of clinical course with no clear…
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…
FDA’s Lethal Weakness Requires More than Committees Sun, 7 Nov 2004 Bloomberg News reports that New York State Attorney General Eliot Spitzer requested information from Pfizer about the promotion of some of its drugs for unapproved uses – the recalled diabetes drug, Rezulin and the antidepressant, Zoloft were named. In…
Intimidation, Politics and Drug Industry Cripple U.S. Medicine – FDA Permits Dr. David Graham to publish Vioxx Report Wed, 5 Jan 2005 FDA officials could not maintain their iron grip in an effort to suppress evidence of far reaching lethal effects of Vioxx when their actions were in full public…
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…
FDA Rejects Crestor Petition–Sacrificing Patient safety Tue, 15 Mar 2005 The FDA’s safety standard for allowing a drug to be marketed has been turned on its head. The law requires that a manufacturer provide scientific proof that a drug is safe and effective before it can be licensed for marketing….
FDA Smoke & Mirrors Musical Chairs Wed, 16 Feb 2005 Amidst widespread public criticism of the FDA’s role as facilitators in the marketing of lethal drugs that killed thousands of people, the Administration made several announcements incorporating terminology (such as: “we’re in an era of openness” “transparency”). But politically correct…
Risk Bearing Children February 27, 2001 Would you volunteer your child to be a "risk-bearing" subject in drug experiments? When Jonathan Swift published A Modest Proposal in 18th century Ireland, he offered a sure solution to the country’s hunger and economic ills: The poor could sell their year-old children as…
Reply to the American College of Neuropharmacology’s Report on SSRI and Suicidal Behavior in Children Jonathan Leo, Ph.D. Introduction The American College of Neuropsychopharmacology (ACNP) recently released an Executive Summary from its Task Force on SSRIs and Suicidal Behavior. The task force concluded that "taking Selective Serotonin Reuptake Inhibitors (SSRIs)…
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…
Drug Companies Move Trials Outside the US Tue, 17 May 2005 Unless the FDA cracks down by enforcing safety and scientific standards in clinical trials, the drug industry is moving its drug trials out of any regulatory oversight. USA Today reports that 50% of trials sponsored by Wyeth Pharmaceuticals were…
