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 . . . Continue reading →
Baycol
Cholesterol lowering drug, Crestor Linked to Patient Death
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2005 Crestor, a highly advertised cholesterol-lowering drug in the statin class–as was Bayer’s drug Baycol, which was withdrawn from market after 30 patients died of rhabdomyolysis (breakdown of skeletal muscle fibers), . . . Continue reading →
Public Servant or Private Marketer? NIH Seeks Inquiry of Alzheimer’s researcher conflicts of interest
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 . . . Continue reading →
Bayer/ Baycol on Trial in Texas – NYT
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 . . . Continue reading →
Cash Interests Taint Drug Advice – NATURE / Death a Risk of Antipsychotics – AP
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 . . . Continue reading →
Calls Mounting for FDA Revamp / Americans Are the most medicated population in the world – DHHS
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 . . . Continue reading →
NIH: Public Servant or Private Marketer?
NIH: Public Servant or Private Marketer? Wed, 22 Dec 2004 David Willman of the Los Angeles Times provides an important reminder that the FDA is not the only government healthcare agency to have betrayed the public trust and lost its credibility. While . . . Continue reading →
FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle
FDA Underhanded Tactics Against Medical Officer Who Blew the Whistle Mon, 29 Nov 2004 The Food and Drug Administration is the epicenter of a collision between medical officers in the drug safety office and senior officials in managerial positions whose focus is . . . Continue reading →
How Did the Vioxx Debacle Happen? USA Today / Lancet
How Did the Vioxx Debacle Happen? USA Today / Lancet Tue, 12 Oct 2004 Dr. Eric Topol of the Cleveland Clinic: “The senior executives at Merck and the leadership at the FDA share responsibility for not having taken appropriate action and not . . . Continue reading →
Bayer Documents: AIDS Tainted Blood Killed Thousands of Hemophiliacs
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 . . . Continue reading →
Trial Lawyers Are Taking Aim at the Drug Industry_NYT
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 . . . Continue reading →
Article
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 . . . Continue reading →