DIR Return Create A Forum - Home
       ---------------------------------------------------------
       MS Speaks
  HTML https://msspeaks.createaforum.com
       ---------------------------------------------------------
       *****************************************************
   DIR Return to: TYSABRI (natalizumab)
       *****************************************************
       #Post#: 1720--------------------------------------------------
       (Abst.) A decade of Tysabri and PML: Tacit transfer of risk
       acceptance?
   DIR By: agate
       Date: June 11, 2017, 8:49 pm
       ---------------------------------------------------------
       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.
       >
       >
       --- End Quote ---
       [References omitted]
  HTML http://journals.sagepub.com/doi/abs/10.1177/1352458516670735
  HTML http://journals.sagepub.com/doi/abs/10.1177/1352458516670735
       *****************************************************
       Page 1 of 1