AHRP Speaks Out AHRP Press Briefing 9/14/04: Antidepressants & suicide-related risks for children Open Letter to NIMH re Prozac & Concealed Suicide Attempts Open Letter to Officials at NIMH AHRP Briefing 2/2/04: Scientists present suicide evidence Conflicts of Interest policy – New York Times Phase I Drug Trials Used Foster…
Bayer/ Baycol on Trial in Texas_NYT Sat, 1 Mar 2003 Melody Peterson of the New York Times reports that in the first case brought against Bayer involving its anticholesterol drug, Baycol, a senior official of Bayer AG testified in court in Corpus Cristi, Texas. He acknowledged that company officials in…
Trial Lawyers Are Taking Aim at the Drug Industry_NYT Sun, 18 May 2003 It appears that trial lawyers will produce the results that government oversight agencies–in particular, the FDA–have failed to do. Namely, to protect the public against an increasing number of unsafe drugs. The pharmaceutical industry whose efforts to…
Risks: Drugs / Vaccines / Trials / Treatment Evidence of antidepressant harm Oct 14, 2005: Andrew Finkelstein Letter to Dr. Russell Katz, Director, Neuropharmacological Drug Products, FDA about FDA’s Failure to Warn about Neurontin-Suicides Aug 29: FDA Response to Utah Court Must Be Truthful Re: Zoloft / SSRI Suicidal Risks…
Bayer Documents: AIDS Tainted Blood Killed Thousands of Hemophiliacs Thu, 22 May 2003 An examination of internal Bayer company documents by The New York Times reveals that the company was engaged in unsavory, probably criminal marketing practices. The documents reveal that Bayer continued to sell contaminated blood plasma causing thousands…
Forbes: Judgment Day for the FDA, Pfizer Wed, 9 Feb 2005 On Feb. 16-18 COX-2 Inhibitor Safety Issues will be the focus of an FDA Advisory Committee and (simultaneously) the European Medicines Agency (EMA). The entire drug industry will be watching with bated breath. Which causal explanation will be offered…
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….
Cholesterol lowering drug, Crestor Linked to Patient Death Tue, 11 Jan 2005 Crestor, a highly advertised cholesterol-lowering drug in the statin class–as was Bayer’s drug Baycol, which was withdrawn from market after 30 patients died of rhabdomyolysis (breakdown of skeletal muscle fibers), has been linked to a patient’s death. “AstraZeneca…
NIH: Public Servant or Private Marketer? NIH Seeks Outside Inquiry of Alzheimer’s researcher conflicts of interest – LAT Mon, 31 Jan 2005 A year after the Los Angeles Times published its first an in-depth investigative report documenting in detail evidence of major conflicts of interest by top scientists at the…
Cash Interests Taint Drug Advice – NATURE / Death a Risk of Antipsychotics – AP Sun, 23 Oct 2005 An investigation by the journal, NATURE (the largest of its kind) reveals that not only do conflicts of interest taint the conduct and outcome of clinical trials, the authors who formulate…
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…
October 14, 2005 link to pdf of original letter Dr. Russell Katz Director, Neuropharmacological Drug Products Food and Drug Administration, FDA 120 1451 Rockville Pike, Room 4037 Rockville, MD 20852 Re: FDA Neurontin Safety Analyses Dear Dr. Katz: Due to the continued public danger facing a substantial class of…
