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…
Failed Drug Treatments for Schizophrenia–Letters to the Editor – NYT Fri, 23 Sep 2005 Letters to the NY Times editor (below) demonstrate the combative reaction of stakeholders in the psychotropic drug industry to the evidence-based overthrow of psychiatry’s treatment recommendations. Psychiatrists who have financial contracts with psychotropic drug manfuacturers, have…
FDA Official Calls Newsletter Unethical – WP / Senate Considers Safety Reform at FDA – LAT Fri, 4 Mar 2005 The Washington Post reports about yet another instance of a high FDA official who misspoke. Dr. Sandra Kweder, Deputy Director of FDA’s Office of New Drugs, sent a letter, “written…
Hoffman LaRoche Rebuffed Call to Monitor Accutane Users – USA Today Tue, 7 Dec 2004 An investigative cover story in USA Today – Drugmaker Rebuffed Call to Monitor Users–affirms the indispensable role of litigation in bringing the facts about adverse drug effects to public knowledge. Lawsuits against Hoffman-La Roche, manufacturer…
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…
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…
Infomail 2004 News Stories on Human Research Protection and Commentary by Vera Hassner Sharav Dec 31: FDA to review “missing” drug company documents Dec 30: Family of Woman Killed by AIDS Drug Test Sues Doctors, Manufacturer Dec 30: Doctors, Too, Ask: Is This Drug Right? Dec 29: Bill would shield…
Pfizer Acknowledges It Failed to Reveal Celebrex cardiac risk found in 1999 trial Tue, 1 Feb 2005 The New York Times reports: “Responding to the Vioxx withdrawal [Sept. 30, 2004], Pfizer said in October that no completed study had ever shown any increased heart risks related to Celebrex. Then, in…
Twin Pharma Give-A-Ways: Biodefense Vaccine /Drug Development Act–S. 1873_ $7 bill Bird Flu Plan Wed, 2 Nov 2005 If the Administration were serious about preparing for an avian flu pandemic–or for ANY health disaster for that matter–the money would be spent on developing reliable infrastructures at the state and local…
FDA Commissioner Lester Crawford Resigns – AP Fri, 23 Sep 2005 The Associated Press reports that the embattled FDA commissioner, Lester Crawford, a veterenarian, who headed the agency since Marc McLellan moved over to the Center for Medicare & Medicaid Services, has resigned effective immediately. Contact: Vera Hassner Sharav 212-595-8974…
Safety of American Drugs Questioned – Assoc Press Thu, 2 Dec 2004 In his CNN news program last evening, Lou Dobbs said the question is no longer whether something is wrong with the FDA’s performance in protecting the public from unsafe drugs–but whether the FDA can even be salvaged? The…
How Health Care in America Became Big Business–And Bad Medicine – OpEd NYT Zoloft NYT Ad Fails to Disclose Suicide risk Mon, 25 Oct 2004 An Op-Ed in Sunday’ New York Times by Time magazine editors, Donald Barlett and James Steele, is a MUST READ assessment of what ails America’s…
