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Tysabri ‘saves’? Not really.
Posted @ 10-Nov-09 15:21 under MS, News by pmbTags: MS, News, tysabri
In early October of this year, the pharmaceutical companies which make and market Tysabri were acknowledging 13 cases of the rare and fatal condition progressive multifocal eukoencephalopathy (PML).
Last week it was disclosed that an additional 10 cases of PML were reported (most of them in Europe; in fact, most of the now 24 reported cases are European MS patients). To say that finding information on any of these cases is difficult is an understatement.
The companies have decided to update the warning label for the drug, which will include the information patients are supposed to read every time they go in for infusion.
The new label will warn that the risk of PML appears to increase with the number and duration of treatment. The companies are sticking to the 1:1000 risk (though 1:800 is a number currently circulating) for patients receiving drug for 24-36 months, but the new warning states that, “[t]here is limited experience beyond three years of treatment.”
Finding information has been VERY difficult and, quite frankly I’m a bit offended (though not completely surprised) that most of the information I’ve been able to have a glimpse is from “financial sources.”
I might be in the midst of making drug choices for the future treatment of my multiple sclerosis. Tysabri has never been on my short list… but I wanted to wait and see how the whole PML situation looked after 10,000 people had been on the drug for at least 24 months. We’ve crossed that threshold and, quite frankly, all is now clear.
I understand that my “ability” to wait is not a luxury all people living with MS have right now.
The vast majority of people taking this drug are happy with their results. The vast majority suffer far fewer side-effects than they did with previous therapies. The vast majority of PML cases have been reported in Europe, where the TOUCH program (the American Tysabri risk management program) details are not known to me.
When, however, I read the anguish of a husband who has lost his wife to PML or a brother who sees his sister as a hollow shell of her former self, unable to communicate and renewed fear in people considering this as their MS treatment, I know that it is time have another open conversation about Tysabri for MS.
I’m not trying to be a harbinger of bad tidings here, but the drug we choose (or the choice to be drug-free) is a part of how each of us lives with this disease.
Current Mood:
Annoyed & 
tearful
Related posts:
- MS drug Tysabri label updated to include PML incidence
- Go (*1) , Tysabri, go. (*1) Go die in a fire.
- More Tysabri-Related PML Deaths, Up to 20 Now
- 7 more PML infections, 1 more death in Tysabri MS patients
- FDA Confirms 3 New Infections Linked To Tysabri