FDA Smoke & Mirrors Musical Chairs Wed, 16 Feb 2005 Amidst widespread public criticism of the FDA’s role as facilitators in the marketing of lethal drugs that killed thousands of people, the Administration made several announcements incorporating terminology (such as: “we’re in an era of openness” “transparency”). But politically correct…
Despite Vow, Drug Makers Still Wtihhold Data – NYT letters Thu, 9 Jun 2005 An important article by Alex Berenson in The New York Times, “Despite Vow, Drug Makers Still Withhold Data,” corroborated the untrustworthiness of drug manufacturers. Their public pronouncements and promises to fully disclose their clinical trial data-including…
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…
FDA Regulators Accused of Trying to Quash Testimony About Cardiac Risks of Painkillers – NYT Sat, 12 Feb 2005 A New York Times front page report announces that President Bush will veto any limits on the Medicare prescription drug giveaway. The administration is adamant about transfering $724 billion in taxpayer…
House Votes to Prevent Pharma-tied Scientists on FDA Advisory Panels Thu, 9 Jun 2005 The House passed an amendment introduced by Congressman Maurice Hinchey (NY) to rein in pharmaceutical industry influence on FDA advisory panels whose recdommendations have resulted in the approval of lethal drugs. Below Merrill Goozner write: “The…
HMO physician applauds Spitzer’s focus on information bias / NYT blind spot Sun, 20 Jun 2004 The affirmation by a Kaiser Permanente physician, Dr. Kate Scannell, that NYS Attorney General, Eliot Spitzer, deserves applause for his “bold and courageous” lawsuit, is an encouraging watershed. The suit, she says, “gives me…
FDA Scientist Won’t Present New Pain Drug Data – FDA to Create Independent Drug Safety Board Tue, 15 Feb 2005 A culture of intimidation prevents FDA safety officers from disclosing important safety information about widely marketed drugs. Reuters reports: “Criticism of how the FDA monitors the after-market safety of drugs…
Glaxo Pricing Under DOJ investigation / GAO Report Says Medicaid Overpays for Drugs Wed, 9 Mar 2005 Reuters reports that GlaxoSmithKline is under investigation by the Department of Justice concerning Medicaid drug pricing. The skyrocketing cost of drugs is depleting Medicaid, the nation’s largest health insturance program paid for by…
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…
At FDA, Graham is still the whistle-blower – USA Today Thu, 17 Nov 2005 On Nov. 18, 2004, Dr. David Graham, FDA’s associate director for science and medicine, blew the whistle in testimony before the Senate Finance Committee, on FDA’s “profound regulatory failure” to protect the public against lethal prescription…
Another deadly drug recalled – FDA asks Congress for Power to Dictate Warnings Tue, 1 Mar 2005 Public pressure has intensified as FDA’s failure to protect the public from unsafe – even lethal drugs. That failure included the failure to at least warn physicians and the public about severe adverse…
FDA Officials Tried to tone Down Report of 27,000 heart attacks on Vioxx – WSJ – WashPost Sun, 10 Oct 2004 The FDA attempted to block a senior medical officer from making his findings known about the lethal hazards of Vioxx: Senator Chuck Grassley stated: “Instead of acting as a…
