Jennifer, an MS patient, recently moved from the Midwest to the West Coast. When she tried to continue her MS therapy, Tysabri, she found that her neurologist wanted instead to prescribe an oral MS therapy from Biogen, Tecfidera, which had some really nasty side effects. When she called her doctor in Chicago he got really upset, saying that “Biogen is trying to twist data to move patients from one therapy to a more expensive oral therapy”.
Tecfidera, like any MS drug, has the risk of serious side effects, including PML via the JC virus. The JC virus is a common infection completely unrelated to MS. About half of the population have been infected by the virus and it is normally kept under control by the immune system causing no problems. If the immune system is weakened and the body is less able to fight an infection, the virus can reactivate and cause serious and potentially fatal inflammation and damage to the brain known as progressive multifocal leukoencephalopathy (PML).
Treatment with some of the disease modifying drugs, in particular Tysabri, can increase the risk of developing PML. A positive test for JC virus (JCV positive) indicates that you are at a higher risk of developing PML, although for most people the risk is still relatively small. However, Biogen is telling doctors that a positive test for JC virus (JCV positive) indicates that patients are at a higher risk of developing PML, although for most people the risk is still relatively small.
Patients taking Tysabri can lead to an increased levels of the JC virus antibody in your blood. With different combinations of these factors the risk of developing PML ranges from less than 1 in 1000 up to 12 in 1000. The test does not indicate if you will or will not get PML. The test indicates your relative level of risk, information which can help you and your MS team make decisions about treatments. If you are identified as being at a higher risk, your health will be carefully monitored for any warning signs of PML. However, the original test to detect the JC virus are not able to tell you exactly how much lives inside you.
Fast forward 5 yrs, now the test for the JC can quantify how much virus is in the blood. You get a number from 0.1 to ??? And Biogen now says if your number goes up from baseline, patients move into higher risk category, meaning most neurons will stop Tysabri and switch to the more expensive Tecfidera. However a lot of neuro’s indicate that big data analysis looking at JC virus numbers will be presented in March at big MS meeting and will show that higher numbers do not match up with higher risk of PML.
Rather than wait and use big data presented at the meeting Biogen is trying to switch patients to the more expensive oral therapy but some MS patients don’t want to switch. I talked to one neurologist who is quite upset at Biogen for not waiting for the data analysis. “They are deliberately trying to switch patients to a more expensive therapy instead of waiting until there is conclusive proof between the JC virus and PML”. Of course, this is his opinion, but I wonder how many patients are being switched with “false warnings”?
I have said before that Biogen is a company that grew too fast and too big. They moved to more expensive facilities in Cambridge and have been laying off staff. Their CEO even bailed out and now a company insider is at the helm while layoffs continue.