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   DIR Return to: TYSABRI (natalizumab)
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       #Post#: 1720--------------------------------------------------
       (Abst.) A decade of Tysabri and PML: Tacit transfer of risk acce
       ptance?
       By: agate Date: June 11, 2017, 8:49 pm
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       From Multiple Sclerosis Journal, September 27, 2016:
       [quote]A decade of natalizumab and PML: Has there been a tacit
       transfer of risk acceptance?
       David B Clifford, Tarek A Yousry, Eugene O Major
       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]
       [References omitted]
  HTML http://journals.sagepub.com/doi/abs/10.1177/1352458516670735
  HTML http://journals.sagepub.com/doi/abs/10.1177/1352458516670735
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