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Keyword: eschenbach

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  • WSJ: The FDA and MS

    04/07/2006 5:56:19 AM PDT · by OESY · 3 replies · 367+ views
    Wall Street Journal ^ | April 7, 2006 | Editorial
    ...The therapy in question is Tysabri, and for many MS patients it appears to halt progression of the degenerative neurological disorder. But a year ago... corporate partners Biogen and Elan "voluntarily" withdrew their drug because of FDA pressure and litigation fear after two patients developed a rare brain infection. That infection might have been linked to Tysabri, since the drug works by suppressing parts of the immune system. But these patients also had other immuno-suppressive therapies, and in any case the MS patients were almost all willing to run the risk.... But shortly before the deadline, the FDA announced it...
  • WSJ: Regime Change at the FDA - Bush needs to speed the drug approval process.

    09/27/2005 5:47:24 AM PDT · by OESY · 3 replies · 323+ views
    Wall Street Journal ^ | September 27, 2005 | Editorial
    ...Which brings us to the politically motivated attack on FDA Deputy Commissioner Scott Gottlieb -- one of the fellow forward thinkers Dr. Eschenbach will find at the agency. In its zeal to find more "cronyism" in the Bush Administration, Time fingered Dr. Gottlieb this week without offering any evidence of any special connections to the White House -- family or otherwise. Time seems bothered that Dr. Gottlieb is young and recently worked in the private sector part-time as editor of a medical technology newsletter. Largely ignored by Time is Dr. Gottlieb's previous experience in a substantial policy-making FDA role under...