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Old 05-16-2010, 11:51 AM #1
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Agate, if you could give the highlights of the article, such as where, how many infusions etc I would really appreciate it. This, of course, is me ***-u-ming you are a subscriber !!
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Linda
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Old 05-16-2010, 12:30 PM #2
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Hi Linda,

I'm not a subscriber and so can't read the entire article. However, I found the Nasdaq article that the Wall Street Journal seems to have got its information from. I hope it's all right to post excerpts from it here:

Quote:
Biogen: Total PML Cases At 49, Deaths At 11 As Of May 6



By Thomas Gryta, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) disclosed three more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 49 as of May 6.

The Cambridge, Mass., biotech company reported no additional deaths in patients that have developed progressive multifocal leukoencephalopathy, or PML, bringing the total to 11.

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 overall global rate is about 0.7 per 1,000 patients, the company said, which falls within the 1-in-1,000 rate previously seen in clinical trials and implied on the drug's label.

Shares of Biogen recently traded down 2.9% to $49.92, while Elan shares dropped 1.4% to $6.26.
Of the total cases, 19 were in the U.S., 27 were in the European Union and three were in other areas. ...

The most recent update translates to a rate of 1.14 cases per 1,000 for patients on the drug for a year or longer, but rises to 1.62 per 1,000 for those on the drug for two years or longer.

A patient's risk of getting PML increases with the number of monthly infusion that he or she receives, something that the Food and Drug administration highlighted in a January safety update. The agency concluded that the benefits of the medicine continue to outweigh the risks.

The rate is about 1.38 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.32 case per 1,000 patients in those using it for one to two years, and it is almost nonexistent in patients using it for less than a year.

...

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

http://www.nasdaq.com/aspx/stock-mar...11-as-of-may-6

Comparing the totals with last month's totals, I'd say that of the 3 new cases, 2 were in the US and 1 in the EU.

Sorry I don't know about the number of infusions but there's an informal Website where they are being recorded. The number of infusions apparently isn't yet known for the last 7 PML cases.
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Last edited by agate; 05-16-2010 at 06:09 PM.
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Old 05-17-2010, 11:46 AM #3
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Thanks agate
I do know about the informal website and go there daily to see if they have more info on the last cases of pml. So doggone frustrating
Linda
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Old 05-17-2010, 12:24 PM #4
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Well I'm sitting here getting infusion #21! It's hard to believe it's been almost 2 years. I'm still on the every 8 week cycle and I haven't noticed any difference except maybe the vision in my left eye gets a little blurrier by the end of the 8 weeks. They renovated the infusion room and added new chairs which aren't as comfortable . But I'm settled in with my pillow and blanket and looking forward to a nap. I kept the box and look forward to reading the new insert to see what exactly has changed. Hope everyone else is doing well.
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Old 05-18-2010, 11:47 AM #5
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The informal website has been updated; 52 pml cases (19 U.S.) and the doses are now posted.
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Old 05-18-2010, 08:50 PM #6
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I am so glad I didn't check in here before my infusion this morning. Seeing the number increasing tends to lead to anxiety before the infusion.

SO, all went well today once they finally got the meds. The did the labs and hooked up the IV and it took them almost 2 hours to get the hospital pharmacy to send up the TY. Apparently there was some mix up and we had to wait for the new shipment to be unloaded from the dock...ugh. anyways, the pharmacy manager came up personally to apologize and she brought me some very pretty peach and red hybrid roses. Which was very nice. They also included lunch with the wait.

Feeling drained as usual, but at least no other yucky symptoms, aside from the blurred vision that showed up in my right eye on the way home. One more to go and we will go in for another MRI to see if it is trying to improve. Kind of funny though, i am on antibiotics to treat the uti from the last infusion.
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Old 05-18-2010, 08:52 PM #7
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Hi Linda,
I haven't seen any more than 49 cases mentioned anywhere else. It's entirely possible that the informal Website has information nobody else has, but until I see it in a more mainstream source, I would wonder about those figures.
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Old 05-21-2010, 02:26 PM #8
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I had infusion # 39 yesterday, with no problems and no concerns.

It was also my third anniversary since I started Tysabri. I've missed one infusion. Since I started I haven't had a relapse. My MRI showed no new lesions, no enhancing lesions. My doc said I am among the 34% who show no clinical signs of disease activity. I have no signs or symptoms except for the lingering spasticity and fatigue.
My MRI report said that the MRI was "unremarkable". It's the only time I have liked being unremarkable!

The assay is in the works. He says he should have it in hand in 2 weeks. He says that everyone who is tested will have to listen to the informed consent speech, and the informational speech, but that the assay is a simple blood draw and that results will be available in 4-6 weeks and that they WILL be releasing the results to the neurologists. He says that the test has a supposed 2% false negative result at this time and that those who test negative will be retested in six months.

I for one am looking forward to being tested so I can move forward with my choice of treatment. Here's hoping that all of us who are tested come out negative!!

I hope everyone's doing well!!
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