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 Center for Drug Evaluation and…

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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 some drug firms from punitive…

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UK issues ban on second SSRI antidepressant for children Sun, 21 Sep 2003 The UK Observer reports (below) that although antidepressant drugs of the SSRI class have not been approved for children, last year doctors (who are unaware of the severe risks associated with SSRIs) wrote 170,000 prescriptions of antidepressants for children in the UK.…

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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 hide the adverse effects of…

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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 Associated Press puts it this…

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Credibility Crisis:Survey FDA Scientists – Death in NIH-AIDS Trial – Tauzin Moves to PhRMA Thu, 16 Dec 2004 A credibility crisis in medical research is smoldering: like the Enron accounting scandal, the prescription-drug debacle is a matter of systemic corruption, including gross and widespread failure by the regulatory process. Unlike Enron whose accounting violations resulted…

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Alliance for Human Research Protection in the Press Feb 17, 2005: FDA Critics Slam Plan for Safety Reform – Nature “This is smoke and mirrors and musical chairs,” says Vera Sharav, president of the New York-based Alliance for Human Research Protection. “They will be using the very same officials that are the problem.” Feb 12,…

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Forbes: Face of The Year: David Graham Mon, 13 Dec 2004   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 public servant putting his personal…

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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 some drug firms from punitive…

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