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   DIR Return to: TYSABRI (natalizumab)
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       #Post#: 1390--------------------------------------------------
       (Abst.) A decade of Tysabri and PML: A tacit transfer of risk
       acceptance?
   DIR By: agate
       Date: September 28, 2016, 8:53 pm
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       Has risk been shifted from the pharma companies producing
       Tysabri to the physicians and patients? That may be what this
       article is saying.
       A "Personal Viewpoint" from Multiple Sclerosis Journal,
       September 26, 2016:
       --- Quote ---
       > A decade of natalizumab and PML: Has there been a tacit
       transfer of risk acceptance?
       >
       > David B Clifford
       > Department of Neurology, Washington University School of
       Medicine, St. Louis, MO, USA
       >
       > Tarek A Yousry
       > UCL Institute of Neurology, Neuroradiology Academic Unit,
       Queen Square, London, UK
       >
       > Eugene O Major
       > Division of NeuroImmunology and NeuroVirology, NINDS, NIH,
       Bethesda, MD, USA
       > Division of NeuroImmunology and NeuroVirology, 10 Center
       Drive, Rm 5N240B, NINDS, NIH, Bethesda, MD 20892
       majorg@ninds.nih.gov
       >
       >
       > The interplay between each of the stakeholder’s
       responsibilities and desires clearly has resulted in continued
       widespread use of natalizumab with substantial risks and an
       ongoing quest for better risk mitigation.
       >
       > In the United States, regulatory actions codified the process
       of risk acceptance—and risk transfer—by escalating monitoring
       and information transfer to physicians and patients. Management
       of medication-related risks is a core function of regulatory
       agencies such as the Food and Drug Administration (FDA),
       European Medicines Agency (EMA), and the medical community.
       >
       > The interaction among stakeholders in medicine, pharma,
       regulatory bodies, physicians, and patients, sometimes has
       changed without overt review and discussion. Such is the case
       for natalizumab, an important and widely used disease-modifying
       therapy for multiple sclerosis.
       >
       > A rather silent but very considerable shift, effectively
       transferring increased risk for progressive multifocal
       leukoencephalopathy (PML) to the physicians and patients, has
       occurred in the past decade. We believe this changed risk should
       be clearly recognized and considered by all the stakeholders.
       --- End Quote ---
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