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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 ac
       ceptance?
       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.[/quote]
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