FDA Bad Faith – Daniel Troy’s pre-emption defense – Nat’l Law Journal Fri, 26 Mar 2004 Federal regulations require drug label warnings if there is “reasonable evidence” of a link between adverse effects and drug action. An article in the National Law Journal shows how s FDA’s chief counsel, Daniel…
October 18, 2002. Pediatric Drug Tests_CNN / NYT Editorial Children are increasingly being exploited for profit by the biomedical industry. Between 1983 and 1997, children had been protected from medical experiments that are not in their best interest. But in 1997 Congress passed the FDA Modernization Act (FDAMA), providing a…
FDA response to AHRP procedural questions From: Cerny, Igor Sent: Wednesday, January 07, 2004 11:52 AM To: Cc: Patel, Anuja; Laughren, Thomas P Subject: RE: FDA Advisory Committee Meeting: Procedural Concerns Follow Up Flag: Follow up Flag Status: Flagged Dear Ms. Sharav: Thank you for your email of December 1,…
Latest Huckstersm: Surgical Implants for Depression – NYT Sat, 21 May 2005 The FDA was supposed to protect the public from snake oil hucksterism. It is appalling to note how far the FDA’s approval process for drugs and devices has veered away from it’s 1962 standards of evidence-based medicine. [1]…
SAMHSA Backs Away From TeenScreen & TMAP Mon, 24 Oct 2005 On October 17, a meeting took place with Charles Currie in Washington DC – with some in attendance by conference call. Currie is the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA), the federal agency charged…
Meta-Analysis: Efficacy & Safety of Antidepressants for Children – Brit Medical Journal Sat, 10 Apr 2004 As news of skyrocketing prescribing of antidepressants for children–especially in preschool children–hit the news waves around the world, a major meta-analysis of the 5 published pediatric antidepressant studies was published in the British Medical…
FDA reviews depression drugs–Intense or Cautious? WashPost/ NYT/ Herald Wed, 29 Oct 2003 The Washington Post correctly reports: “The association between antidepressants, particularly the selective serotonin reuptake inhibitors (SSRIs), and suicide has been controversial since the first SSRI, Prozac, came on the market in the late 1980s.” But stakeholders in…
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…
Guardian Reports: MHRA to Issue New SSRI Restrictions Mon, 14 Jun 2004 The Guardian reports that the British Committee on safety and Medicines, which was first to issue warnings about the potential suicidal risk for children prescribed an antidepressant of the SSRI class, are now about to issue similar warnings…
AMA Serves Pharma Marketing Priority/ FDA To Add Warnings on ADHD drugs–Concerta, Ritalin, Strattera, Adderall Wed, 29 Jun 2005 The FDA is finally taking note of the fact that many drugs prescribed for the treatment of psychiatric problems are CAUSING serious psychiatric and cardiovascular problems in children and adolescents !…
Drug safety Hearings-Sept-Congress/ FDA – Lilly Plans to Disclose Data Tue, 3 Aug 2004 A hearing about the possible connection between suicide and antidepressant drugs will be held on Aug 4, by the California Senate by Sen. Tom Torkalson, chairman of the Senate Task Force on Youth and Workplace Wellness…
British Shake-up for drug licensing body Thu, 11 Nov 2004 “The damage done by the public believing they have been lied to or defrauded is difficult to repair.” A shake up is taking place in the UK as the culture of secrecy and the pharmaceutical industry’s influence on the Medicines…
