A decade of natalizumab and PML: Has there been a tacit transfer of risk acceptance?

Abstract

The interplay between each of these 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 acceptanceand risk transfer-by escalating monitoring and information transfer to physicians and patients through 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 interplay between 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 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.

High-frequency MRI monitoring should be performed in natalizumab-treated MS patients with higher risk of PML – Commentary

“…Thus, this discussion leads beyond, and calls for a health care system that supports the time invested by independent physicians and researchers seeking the best outcome for patients, and spending time on developing novel strategies to mitigate and combat treatment-associated risks. 12 …”

Editorial: Inflammation in the CNS: Advancing the Field Using Intravital Imaging

“…These include autoimmune conditions such as multiple sclerosis (MS), progressive degenerative conditions [Alzheimer’s disease (AD)], sterile inflammation as occurs in stroke/cerebral ischaemia, and inflammation stemming from parasitic, fungal, viral, and bacterial infections. Whilst recent developments have led to improved outcomes in some of these conditions, most notably MS ( 1 ), there remains concerns with these approaches ( 2 ). Furthermore, there is an increasing prevalence of AD and stroke among the ageing population in the developed world, whilst in sub-Saharan Africa, cerebral malaria remains a major cause of mortality.…”