This Is MS Multiple Sclerosis Community: Knowledge & Support

Biogen Idec Inc. disclosed three more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp., bringing the total number of cases to 58 as of July 2.

The Cambridge, Mass., biotech company reported an additional death among patients that have developed progressive multifocal leukoencephalopathy, or PML, bringing the total to 12.

Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped due to concerns about the risk of PML that led to its temporary withdrawal beginning in 2005. The infection re-emerged in mid-2008, and Biogen provides regular updates about the number cases....Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905

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Squiffy's House of Fun - Laughter for Multiple Sclerosis

Squiffy, so disappointed to read this news, I am considering starting Tysabri. Any additional detailed info. on these individuals? what country are they from? Thanks! Indigo

HI Indigo. not at present.

As you are considering Tysabri please have a read of the MSRC's Tysabri Users Diaries to help put things in perscpective - http://www.msrc.co.uk/index.cfm?fuseact ... ageid=2697

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The Multiple Sclerosis Resource Centre

Squiffy's House of Fun - Laughter for Multiple Sclerosis

I use it and its easy and painless. I want to know if the people w/ PML were here or in Europe.

Hi, Chris,
2 newest PML cases are from the USA (woman and man - 48, resp. 59 doses of Tys) and one woman is from Switzerland (Europe) - 52 doses.

The news articles I have been reading report a death among the 3 new cases, but nowhere does it state where the death occurred. Of the above 3 cases of PML, do you know which individual died?

Also, do you have a link/source for the info above? I have googled till my fingers are blue and while the 3 cases and the death are mentioned, I have not found these specifics anywhere. I ask because I am reporting back to a support group, several of our members take Tysabri.

I like to give them links so that they can print the material and discuss it with their physicians.

Many thanks.

Dottye

Here's what I am not understanding while reading the many news reports, and here's a typical report:

http://de.advfn.com/news_Biogen-3-More- ... 23955.html



The wording, to me, is fuzzy.

Are they reporting that 3 additional cases of PML have occurred; and, independently and separately, 1 of the individuals among the 58 who have contracted PML since Biogen has been reporting the case incidents, yet another has died (but not necessarily one of the three new cases?)

Perhaps I'm just dense, but it seems it could be taken this way. That someone who had become ill at an earlier time has now succumbed to the disease.

Any help with this appreciated.

Thanks.

Dottye

Biogen stated many times:
"All physicians will receive all the information aboutnew cases of PML on their request."
Dottye,
sorry I do not mention my source. Please notice that TIMS ever mentioned sources have been closed for patients within few weeks after disclosing it here...
It is the only source that I know and I want to use it in a future...

I understand about protecting your source. No problem.

The problem we're having here is that the doctors don't seem to have the time or inclination to "request" the info from Biogen. Nor to convey it to patients during a short visit.

To my mind, it should not be the doctor's responsibility to request the info month after month.

Biogen obviously has a list of those physicians participating in the TOUCH program here in the US -- it would be a simple matter, IMO, to provide this info in a timely manner to the physician. Big corporation, I'm sure it has resources that many smaller physician practices do not.

Thanks.

Dottye

Customrrs/patients spending a lot of money for Tys do not have a right to be informed? I believe in responsible and open minded physicians...

January 25, 2010:
"Biogen Idec Inc. will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech firm strives to find the right balance in keeping the medical and financial communities updated on that number.
Under the new plan, Biogen will update physicians midmonth and provide information through a password-protected Web site.It will include the number of PML cases, with an incidence rate broken down by duration of use, as well as a cumulative patient exposure figure, which is different then the quarterly patient count provided to investors.
Investors can get the same information from investor relations, although the company won't be posting it on a public Web site or making an announcement.
Patient services will provide Tysabri users with information upon request, although not with the level of detail given to physicians, or even to investors."

I heard about that website, thanks for posting the specifics.

It seems to me that the majority of folks accessing it are the brokers and analysts, which is where I get all my Tysabri updates -- from the financial pages (I have a Tysabri Google alert in place).

I love that, hearing medical news from a financial analyst, along with the stock tip on Biogen/Elan (buy/sell/hold) and projections on future stock. It's oh so ... reassuring.

Thanks, again.

Dottye

I do not mean to be rude but does it matter where the cases of PML are from?

I am concerned because people are getting PML and dying from it and whether its here, Europe or anywhere else it is extremely worrying. I am sure they are as careful in Europe,etc. as they are here. In fact my daughter's former neuro was ready to put her on Tysabri immediately - she was taking Rebif and had not long finished a heavy course of steroids. He had no intention of her having a cleaning out period which I found extremely worrying and when I questioned that he said there was nothing to worry about. He is a top neurologist.

What I do know is that the TOUCH program does not really do anything to follow-up on patients and when you call them with a question or worry they tell you to call your doctor so what is the point of being part of that program?

My daughter has just had her third Tysabri infusion and frankly I feel sick at the thought of it - I wish I could say she has seen remarkable improvements. To date she has had none and that coupled with the fear of PML I just wonder if it is worth the risk?

Drury

Well ... to the people in my support group it does seem to matter whether it is in the US or in Europe. I'm not even on Tysabri and I find it of interest.

If you look at the initial #s, the preponderance of cases were not in the US -- some people felt that the TOUCH protocol was effective, and that gave them a sense of security. I can't say if that was or is significant or not, I just know that it was the feeling at the time.

And it's my understanding that various countries have different protocols. Perhaps that might contribute to varying outcomes?

In the grand scheme of things, of course it matters that anybody, anywhere is stricken with PML. We all have MS, and no one wants to see someone fall ill from a treatment protocol.

Since I am not myself taking Tysabri, I only know the bare bones of the TOUCH protocol, but I would think it is the physician's or the infusion center's responsibility to answer any questions, and if they can't (which would amaze me) then they need to be in touch with Biogen's administrators of the TOUCH protocol. I suspect that the folks at the administrative end are primarily collecting data?

I'm sorry that your daughter has not seen remarkable improvements. I will hope for a good outcome for her, and for your peace of mind.

Dottye