FDA to review “missing” drug company documents Fri, 31 Dec 2004 Related Link: Peter Breggin, MD RE: Eli Lilly’s Contentions that the BMJ Prozac Documents were Never Missing and Have No Significance In the final hours of 2004, an investigative reporter for the British Medical Journal obtained long “missing” Eli…
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…
Eli Lilly Prozac Documents: What do They Reveal? Thu, 27 Jan 2005 A report in the BMJ (formerly the British Medical Journal) that relied on internal Eli Lilly documents to challenge Lilly’s claims about the safety of Prozac has stirred a prickly hornet’s nest. [1] The documents show, among other…
Next Phase in Psychiatry? Or, NIMH Effort to Rescue Bad Drugs – WSJ Fri, 29 Jul 2005 The Wall Street Journal uncritically reported: “The results of the largest studies ever conducted of depression and schizophrenia will be released in coming months, potentially transforming the way patients are treated and shaking…
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…
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…
AHRP Position Statement on Mental Health Screening – FDA Hearing Re: Drug Advertising Wed, 02 Nov 2005 FDA is holding public hearings (Nov 1, 2) Re:Â Direct-to-Consumer Promotion of Medical Products at: National Transportation Safety Board Boardroom and Conference Center 429 L’Enfant Plaza, SW., Washington, DC 2 Time: 9:00 –5:00….
Pittman-Zoloft Trial to begin_ Another Boy on Prozac is Charged in Father’s Slaying – AP Sun, 30 Jan 2005 The Associated Press reports about a homicide case (below) – this time involving a 10 year old boy who is charged with killing his father. AP reports that the child was…
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…
FDA Public Health Advisory: SSRI-Suicide link in adults Wed, 20 Jul 2005 The American Medical Association is attempting to trivialize the hazards of prescribing SSRIs to children, urging physicians not to allow the evidence to interfere with their prescribing habits. See: http://www.ama-assn.org/ama/pub/category/print/15186.html The AMA has done the public a disservice…
NIMH Offers Grants to Study SSRI relation to Suicidality_FDA to Examine SSRI- Suicide in Adults Mon, 14 Nov 2005 A fifteen year struggle by critics of the drug-centered treatment paradigm in psychiatry is being indirectly validated both by the FDA and the National Institute of Mental Health who are addressing…
Lilly Withdraws Duloxetine Application from FDA Fri, 28 Jan 2005 Eli Lilly and Boeringer Ingelheim have jointly announced that they have recinded their U.S. FDA Application for Duloxetine for Treatment of Stress Urinary Incontinence. http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=154081&print=yes Withdrawal of an application from FDA approval process is usually the result of the manufacturer’s…
