So I just got off the phone with my neurologist and got some useful information. She listened to the conference call last night that Biogen did with the neurologists. Here is what I found out.

8 out of the 24 cases have been in the U.S.
60% of the patients taking Tysabri are from the U.S.
4 deaths from PML out of the 24.
64,000 are currently on Tysabri (she said this is what Biogen told them but everything I've seen in other articles says roughly 46,000--so this was confusing even though I asked her if she was sure). Take this number with a grain of salt. Maybe she flipped the digits in her mind.

It's not clear how long the EMEA had the information about the PML cases which they got from Biogen. The FDA could have had the info but the EMEA decided it would go public last Friday. She said, clearly something different is going on in Europe in terms of cases.

As far as her opinion, she essentially said that we are in a wait and see pattern because there just isn't a lot of clinical information/evidence out there. She said she and her fellow neurologists are on top of things -- as a larger community they may have to decide how to proceed--holidays, how long people should be on it, who should be on it-- as more info comes to light as time goes on. She also noted that Biogen is a business so we don't even know if we are getting all info--profits drive Biogen obviously. We don't have much clinical data on the Tysabri holiday idea (how long should you be on the holiday, who should go on it etc.) However, she said that studies show MS activity seems to come back in 6 months when you go off Tysabri. It takes 3 months for the drug to get out of your body. So if she recommended a holiday it would be for 4-5 months (splitting the difference). She initially was against holidays because of the antibody issue. Now she is saying that for someone like me (who didn't have very active or aggressive MS when I started Tysabri) I should consider a holiday. But I'm on #17 and we will reassess at the 24 month mark. She also mentioned that she thought the antibody issue would be less of a problem if you had been on Tysabri for awhile (not a short time 2-4 months) and then go back.

There is more but I can't remember it all right now -- If I remember more I'll post it! There still seems to be a lot of "we just don't know" answers. I feel like I did when I found out I had MS and was asking a million questions about the disease-- "we just don't know."

RW,

Do you know how many people in France are on Tysabri? That's interesting, especially if lots of people are taking it there.

Natalie,

That info actually makes a lot of sense. But I think the 64,000 is about how many patients have taken Tysabri in total (not how many are on it now). The person from Biogen that I spoke to the other day gave me that number as the historical number of patients.

I see my neuro tomorrow so I need to make my list of questions for him.

Thanks for clarifying Wiz. I'm anxious to hear what your neurologist has to say. There are so many unknowns. As my neuro said, the drug has only been on the market for 3 years and we really don't know on a widescale the long term effects after 3 years. So I guess they learn as they go. Suddenly I feel like a guinea pig!!

NMSS Update on Tysabri & PML
 

This update was published 10/29 on the NMSS Home page. It is much more detail than we've had in awhile, and echos a lot of what Natalie's neuro said.

http://www.nationalmssociety.org/new....aspx?nid=2308

More on France, this article is from 2007 when Tysabri was approved in France. They have been infusing since a week before this article was published:

http://www.apmhealtheurope.com/story...46&numero=6296

"...Asked by APM about rapidly evolving MS, Prof de Seze explained that natalizumab can be administered after mitoxantrone, which is limited to six infusions due to toxic haematological effects, but that there must be a time lapse between the two to allow the immune system to recover. He considers it preferable to offer a different immunomodulator after mitoxantrone, or natalizumab before mitoxantrone.
In France, natalizumab can only be prescribed by hospital neurologists. Certain precautions have to be taken before treatment initiation, mostly due to the risk of PML. A brain MRI must have been carried out less than three months previously and neurologists must check for immunosuppression and latent tuberculosis. If previous immunosuppressive treatment has been used, there is a six-month delay before Tysabri treatment can be started, to give the immune system time to recover."

I don't know how many people in France are on Tysabri. They don't seem to be having any of the problems that Germany is having or we would be hearing about it.The patients first infused in France are about where Wiz and I are right now and so far, no PML reported there from any of the information I can find.

The German patients do NOT seem to be having a lengthy washout from mitoxantrone, they do NOT seem to have the monitoring that we have and that France has, and for two countries who started infusing around the same time, the discrepancy in PML cases is outstanding between France and Germany.

As far as the CD4/CD8 testing, it's possible that you get tested as a part of your bloodwork. Ask your neuro exactly what he/she tests for when they do bloodwork as a part of their monitoring.

The Tysabri rate is 60%US/40%ROW as Natalie stated. The figure of 64K is also correct +-. This figure is all patients who have been exposed to Tysabri, including trial patients and people who have discontinued Tysabri. I believe the 45K+- figure is people who are on Tysabri post market retail (since 2006 return to market) and does NOT include trial patients who are in STRATA, TYGRIS, etc. so that is where the discrepancy in the numbers comes from.


My news:
I received a second call from Biogen yesterday. We ARE having an effect. They are being swamped by calls, our points are being presented clearly and the top brass is getting the messages and is listening to the monitored and taped calls.

When asked how long would be too long for them to make a decision as to how to get the information out to patients, I said that people are already speaking with news agencies, calling senators and that suggestions have been made as to more direct protests, including refusing one infusion in one month across the board if need be, but that they do have some time but that shouldn't be construed as more than two to three months.

I reminded him that we as patients are the best advocates for other patients, that Tysabri is a patient driven drug, but that none of us are feeling comfortable right now with what we can tell new people who ask us about our Tysabri experience and that replies are starting to include the fact that we as patients who have been on Tysabri for a long period are being held back by not receiving information about the new cases of PML announced by the EMEA and the FDA, and no word from Biogen and Elan, that our physicians are busy and don't have time to do Biogen's job, that it costs many patients money to see their physician, even if just to ask questions and be given up to date information. I also spoke about the fact that we get faster and more information from financial news agencies than we get from Biogen. I reiterated the fact that we are not asking for names or for people's privacy to be violated, but that we do want country, age, sex, length of time on Tysabri, previous treatments taken, length of washout time, and updates on condition and followups.

I also reminded him that if it wasn't for patients in 2006 at the FDA hearings and working in the background, that Tysabri more than likely wouldn't be on the market right now, and that we did that with little help from Biogen and that with the internet, patients around the world are communicating about this problem and working together to change it.

I'm urging people to continue to call, write letters to any addresses you have for Biogen and Elan, including investor relations, and speak with other Tysabri patients you know, whether they are using the same neuro, infusion center, people you know on Tysabri that you speak with on the net, go to other boards that you know of and get the word out. When speaking to someone personally at Biogen or Elan, please be as polite and professional as possible, state the facts, try to get names, call back numbers and email addresses and share them privately since most emails are not public and we want them on our side in a positive way.

We ARE making a difference here but they need to keep hearing what we have to say.

:grouphug:

All of this is quite frightening, but tysabri has worked so well for Chris that it would also scare me to death for him to take a "holiday" from it.

While I congratulate Biogen for finally saying something, their statement released on the NMSS home page is a disappointment.

They have got to put something in place that gives patients ALL the information they need, not just a general statement full of information that anyone with a computer who searched on this matter since Monday could have found on any investor site or financial news site and also by just reading this thread!!

Deb,

I feel the same way about Tysabri. It's been a miracle for me, and I don't ever forget where I was before and how I got where I am now BUT I am not willing to play Russian Roulette with my life when it comes to information Biogen has but does not share with patients. We need full disclosure of all the details, not just a spoonful of general information.

We just got home and I chose not to get my infusion today. The neuro spoke to me for about an hour. I'm going to go back in three months and talk about whether I want to go back on Tysabri, or go on something else. I'll check back in later with more details. I have another appt this afternoon and won't be home until later on.

That must have been a difficult decision..:hug:

Wiz --- :hug::hug::hug: