Tuesday, August 12, 2008

On My Mind

Update II: My readers are the smartest, most informed readers EVER! Your comments made me feel much better while showing me how little research I did on this subject. I was really upset that 2 new cases of PML happened that I don't think I took the time to look into it all, as I should have done. But thank goodness you had the calmness of nerves and clarity of mind to do your homework. All I can say is, bless your buttons!

Update: The whole infusion center was buzzing with this subject and the general consensus was exactly as the comment says on here. The most interesting part of all this was how many different ways people say Tysabri. Tie-sob-reee, Tay-sab-reee and so on, everyone sticking to their own favorite way of saying it regardless of how the other person in the conversation was saying it.

I have so many things I could talk about (as always) but right now I have to get this off my mind so I can move on. I was reading on the NMSS website that there have been 2 new cases of PML in people doing Tysabri. In Europe 2 men who had each been on Tysabri for over a year started having major neurological problems that were not consistent with MS. *Sigh* I had hopes that there would never be another problem with Tysabri and that I would spend the rest of my life happily on it; but now I feel like Tysabri is an endangered species. The men went through a process, which I can't remember the name for right now, to get all the Tysabri out of their systems and did a bout of steroids to try to lessen the attack. They had areas of major damage in their brains consistent with PML, and there is no known medicine to help combat PML. For a little while there, when it looked like Tysabri only brought about PML with the help of another immunosuppressent, the odds of getting PML became very small. Now they are back to about 1 in 1000. That doesn't worry me. I would rather get PML than not be on Tysabri, but I am afraid I may not have that choice. I am off to do Tysabri today, (damn the torpedoes!) and take my chances. In the words of Emily Bronte, "No coward soul is mine."


Lisa Emrich said...

I sincerely do not believe that Tysabri will be taken off the market. I reviewed the news regarding these 2 PML cases on my blog. (search Tysabri)

Lauren said...

Hi Blindbeard,

I do hope your Tysabri infusion goes well... I had my 24th infusion on Wednesday, 8/6.

After reading your blog entry "On My Mind", I should point out that the two men in the European Union were not having major neurological problems; the first patient was tested for the JC virus, and initially, it came back negative (in other words, the JC viral load was very small)...because this patient developed new neurological problems consisting of left upper extremity twitching and weakness, additional testing was performed and a formal diagnosis of PML was made - after plasmapheresis exchange, this patient is now home and is still ambulatory;

The second patient was previously treating with azathioprine for ten years in conjunction with beta-interferon, and he subsequently developed left sided weakness with cognitive changes. He also received plasmapheresis exchange.

In April, Biogen Idec released safety data showing that over 32,000 patients had received the drug worldwide, with approximately 13,400 having been on the drug longer than 12 months, and 6,600 having been on treatment for over 18 months, with no new cases of PML identified. This resulted in a change of perception that the risk of developing PML with natalizumab from 1 in 1000 to 1 in 10,000.

Therefore, the risk is still well within what is stated on the Tysabri label, which is now 5 in 13,400 so I seriously doubt that this medication will ever be removed from the market again, as long as the risk stays no more than 1 in 1000.

Because of the above, and more than 20 Conference Calls held by Biogen last week with neurologists, the majority of neurologists are still prescribing Tysabri for their patients & the majority of MS patients currently on Tysabri are remaining on Tysabri.

The risk of PML is still very small and each patient goes on Tysabri therapy being educated of this fact.

All my best to you dearheart,

Lauren :)


Yeah, what Lauren said. LOL

Linda D. in Seattle

Lisa Emrich said...


I've got a Tysabri project underway. Please stop by sometime and help contribute some information.