PML is a rare and usually fatal disease that occurs almost exclusively in people receiving certain kinds of drug treatment, including natalizumab (Tysabri) for MS.

Some of the medicines associated with PML bring major benefits to large numbers of patients. Therefore effective ways to manage the risk of PML, through identification of patients at risk as well as early diagnosis and treatment of PML, are of major public-health importance. Medicines regulators in Europe and the US are trying to influence the research agenda to broaden the knowledge base for medicines regulation.
Some 170 experts and stakeholders from regulatory authorities, research funding bodies, academic and clinical researchers, patients and healthcare representatives and industry discussed a common way forward for research in drug-related PML

Christoph Thalheim, Secretary General of the European MS Platform was a co-moderator and represented the patients’ view in an opening speech and closing remarks. In a speech prepared in consultation with people with MS and caregivers, Christoph described the importance of patients’ input to ongoing health care discussions and decisions and spoke of the difficulty in striking the right balance of benefits versus risks when deciding for or against a therapy which is highly effective but carries the risk of causing severe disability or even death.

While the workshop was focused on PML, it was acknowledged that this type of collaborative research model could become a blueprint for research into other drug-induced diseases.

The immediate follow-up to the workshop will include finalising a research agenda on PML and its dissemination to funding bodies and the research community, as well as fostering further partnerships and research collaboration.

For more information and presentations of the workshop, please consult: www.ema.europa.eu

[adapted from an article by EMSP]