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…
NGO Probe to Look at Foster Kids in AIDS Drug Trials – NYC Sat, 23 Apr After a year of stonewalling, the New York City Administration for Children’s Services has announced that it would seek “an independent review” of the AIDS drug trials that were conducted on children in the…
Drug intoxication defense breaks new South Carolina legal ground: Pittman /Zoloft trial Sun, 13 Feb 2005 In South Carolina, temporary insanity does not influence punishment. If found guilty of murder – whether by reason of insanity or not, the sentence is 30 years to life with no parole. Defense attorneys…
CNN / Mercury News: Bioshield Vaccine Contracts to mfg with “closest ties with the government” Sun, 18 Sep 2005 Questions are being raised (again) about the government vaccine purchasing program, ostensibly as a measure to protect the American public in the event of a bioterrorist attack. Mercury News (Twin City,…
Evidence-based medicine? Overdosed America: The Broken Promise of American Medicine Thu, 17 Mar 2005 Dr. John Abramson is a physician who spent more than twenty years as a clinician treating patients in Appalachia and Massachusetts before writing “Overdosed America: The Broken Promise of American Medicine.” “When I first read of…
FATAL FLAW Efforts to Overturn SSRI Black Box warning before it has even been implemented Date: Mon, 24 Jan 2005 Even as the Black Box Suicidality Warning on SSRI antidepressant labels have not even been implemented, aggressive efforts are underway by a powerful consortium of medical-pharmaceuticaql self-interest groups – among…
Lilly Consultants dismiss significance of suicide risk while Lilly will issue Black Box warning label for Strattera Mon, 10 Oct 2005 On September 29, the FDA issued the public health advisory alerting health care professionals that children and adolescents taking Strattera prescribed for ADHD should be closely monitored for changes…
