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Biogen, Elan push back on Tysabri study
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Biogen Idec and Elan are soft-pedaling research released yesterday that showed the virus responsible for a potentially fatal brain disorder is activated--and the patient's immune system weakened--by their multiple sclerosis drug Tysabri.
As you know, a Harvard Medical School doctor and his colleagues studied 19 patients who had just started Tysabri treatment. Urine samples showed that levels of the virus leapt after one year on the drug. But Biogen maintains that a patient's virus levels by themselves don't indicate whether he or she will end up getting progressive multifocal leukoencephalopathy, and that's why the company is studying a host of other potential contributing factors.
Getting to the bottom of just what causes PML in Tysabri patients could help Biogen and partner Elan further grow sales of the drug. Tysabri was pulled from the market after PML cropped up in a few patients, and then reintroduced under a risk-management program. Since then, a handful of Tysabri patients have developed the disorder. (Some 56,000 patients are using Tysabri now, Elan says.) Doctors have learned how to better treat PML, however, and some are experimenting with treatment holidays to help prevent the infection.
- read the Irish Examiner story
- get more from Reuters
Related Articles:
Researchers identify Tysabri-PML link
Biogen reports 11th PML case for Tysabri
Latest PML case sets Biogen investors off
Elan CEO defends himself, Tysabri
Comments
By Anonymous | Posted 2:24am | September 12, 2009
At the end of July, Biogen stopped disclosing on a weekly basis the number of new patients with PML. Want to know how everyday people like you and me will find out? That's a question I've asked my neurologist. The response: Biogen plans on having the pharmaceutical representatives tell the doctors about new cases! Do you really think they will tell the truth, and if they do, do you think they will be expedition about it? This infuriates me! I was able to find out about the new cases on the Internet by setting up a Tysabri Google alert. I was able to keep up on the new cases of PML before July, but now all I get are e-mails about Biogen and Elan's fight in court. I suspect the company's decision to discontinue the reporting was based on their stock prices. I think it’s a way for Biogen to hide their true numbers.
I was on Tysabri for 20 months. I went off of it in June for a holiday after I became ill with an upper respiratory infection. In the mean time, I started on low-dose naltrexone (LDN). I have to say I’m so happy with it and I’m really hoping I don’t have to go back on Tysabri. I told my neurologist I wouldn’t be going back on any disease-modifying drugs until after I see the results of my next MRI (scheduled in November). If the MRI shows no progression, I plan on staying on LDN exclusively. After reading the latest information between the correlation of the JC virus and PML, I hope I never have to go back on it.
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