Author Topic: (Abst.) A decade of Tysabri and PML: Tacit transfer of risk acceptance?  (Read 115 times)

0 Members and 1 Guest are viewing this topic.

Offline agate

  • Administrator
  • *****
  • Posts: 9822
  • MS diagnosed 1980
  • Location: Pacific Northwest
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.


[References omitted]

http://journals.sagepub.com/doi/abs/10.1177/1352458516670735
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

 

Related Topics

  Subject / Started by Replies Last post
0 Replies
149 Views
Last post September 28, 2016, 04:53:58 pm
by agate
0 Replies
117 Views
Last post November 16, 2016, 08:37:33 am
by agate
0 Replies
131 Views
Last post April 23, 2017, 03:47:31 pm
by agate
5 Replies
231 Views
Last post June 05, 2022, 04:37:54 pm
by agate
0 Replies
80 Views
Last post June 27, 2020, 08:54:06 pm
by agate