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  • wallstpirate wallstpirate Nov 24, 2013 8:54 AM Flag

    Boston Globe article part 1

    Patients’ advocates press FDA to retain lifesaving drugs

    Karen Linscott, of Eden Prairie, Minn., took the leukemia drug Iclusig in a clinical trial. She was among patients who appealed after Iclusig was pulled from the market on Oct. 31.

    Within hours after sales of a powerful new leukemia drug were stopped last month because of potentially lethal side effects, loosely organized groups of doctors and patients — determined to keep getting a medicine they depend on — sprang into action across the country.
    They began making calls and writing letters to regulators, seeking assurance that people already taking Iclusig, developed by Cambridge’s Ariad Pharmaceuticals Inc., would have uninterrupted access to the treatment while Food and Drug Administration officials pored over new clinical data on its toxic side effects and haggled with Ariad about revised wording on a warning label.
    “I was terrified because this drug is my lifeline,” said Karen Linscott, a 48-year-old teacher from Eden Prairie, Minn. Her form of blood cancer — chronic myeloid leukemia — has been in remission for two and a half years since she began taking Iclusig as part of a clinical trial in Ann Arbor, Mich.
    Soon after the drug was pulled from the market on Oct. 31, Linscott and other patients appealed to an FDA patient liaison in an hour-long conference call. “They had to hear from the patients and the doctors,” she said.

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