Forbes: Face of The Year: David Graham Mon, 13 Dec 2004 Â Forbes magazine has named Dr. David Graham the Face of the Year’ for his “steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses.” Dr. Graham took a courageous stand as a responsible…
FDA’s Double Standard Re: Advisory Committee Membership Mon, 15 Nov 2004 FDA’s inexplicable actions–the latest being the removal of Dr. Curt Furberg from an FDA advisory committee for alleged "intellectual conflict of interest" – demonstrate hypocracy and intellectual dishonesty. Dr. Furberg independently analyzed the scientific data, concluding: "The result is…
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…
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 on facilitating new drug approvals. Officials at the…
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 recognizing that they are accountable for the public…
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…
Drug Warnings: Are They Effective? USA Today Tue, 26 Apr 2005 How effective are drug warnings? USA Today reports that experts are unsure. For example, a study in the January issue of Pharmacoepidemiology and Drug Safety focused on Ohio Medicaid claims for Rezulin prescriptions – the diabetes drug had been…
Two items in today’s New York Times illustrate the contrast between what the Administration claims it’s legislative / regulatory proposals will do for health care, and what they actually do after they’ve taken effect.
Abbott Seeks FDA approval for cancer drug despite failed trials – WSJ Mon, 12 Sep 2005 Abbott Laboratories is asking the FDA to approve a cancer drug even though it failed in clinical trials to demonstrate a benefit greater than placebo–which is a minimal FDA requirement. The Wall Street Journal…
New Diabetes Drug Increases Mortality / Morbidity – FDA “approvable” letter Challenged Fri, 21 Oct 2005 Today’s newspaper reports about a lethal new diabetes drug that the FDA was poised to approve makes abundantly clear that The New York Times got it wrong when it gave the FDA high marks…
“Lilly is Hiding Negative Information About Zyprexa” – SAPS Wed, 2 Nov 2005 From our colleague in Sweden: A published interview with Dr. Curt Furberg, Professor of Public Health Sciences Wake Forest University Baptist Medical Center, and Chair, Steering Committee, and Principal Investigator, of one of the most important studies…
Vioxx Fallout: Merck Officials Intervened–NYT / FDA Officials Intervened–Mother Jones Mon, 25 Apr 2005 Mother Jones and The New York Times focus on the Vioxx fall out–a case that encapsulates the corrupt practices in drug research. Merck and FDA officials intervened to conceal the lethal cardiac effect of Vioxx. Mother…
