What is it about?

Tysabri is a drug used in multiple sclerosis but is associated with a deadly brain infection, called PML. A program to monitor PML, called TOUCH, was created by Biogen Idec, the company that markets the drug. However, it is flawed since tracking PML with JCV Ab status is not mandatory. Physicians can ignore or forget to check for JCV Ab and the company does not insist it, either. The patient can lose in the end since PML can go undetected.

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Why is it important?

PML is a deadly brain infection seen in patients using Tysabri. There are currently 635 PML cases worldwide and tracking PML using the TOUCH program, created by BIogen Idec, is riddled with flaws. There is no mandatory requirement to test for JCV Ab status in the TOUCH program. This exposes the patient to PML risk without the doctor or the patient being aware of the infection till it is too late.

Perspectives

I had seen many a patient in this situation. Fortunately, none of them had PML but luck is not the best tool to screen for PML.

Dr Jagannadha R Avasarala
Greenville Memorial Hospital

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This page is a summary of: The TOUCH program and natalizumab: Fundamental flaw in patient protection, F1000Research, December 2015, Faculty of 1000, Ltd.,
DOI: 10.12688/f1000research.7513.1.
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