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Old 07-31-2008, 08:53 PM #11
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Originally Posted by Natalie8 View Post
Hi Cherie, your first link was a dead end. Can you cut and paste? Thanks.
Hopefully it works for you now.

Cherie
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Old 07-31-2008, 08:54 PM #12
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I wonder if they're using the TOUCH program in Europe? I think that's where it happened. I wonder if these two could have been taking other immune suppressant drugs?

This is so sad. I hope they were able to get it out of their systems quickly enough to avoid too much damage.
They have a modified TOUCH protocol, as I remember. It's not as stringent as the one here in the US.

I am sure that there won't be any stones left unturned by any investigative body regarding these two cases.

Considering the fact that these are the first two MS cases of PML on monotherapy, I am sure that everyone will be on high alert.
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Old 07-31-2008, 09:03 PM #13
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Sally, this link has the amount of people using Tysabri. However, I am not sure if the number is correct. It seems numbers vary depending on what news report your reading.

http://www.bloomberg.com/apps/news?p...kFY&refer=home

More than 31,800 multiple sclerosis patients use Tysabri, Biogen spokeswoman Naomi Aoki said. About 14,000 patients have taken Tysabri for more than a year, and 6,500 patients have taken it for 18 months or longer.
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Old 07-31-2008, 09:04 PM #14
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Thanks! Now it seems to be working.
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Old 07-31-2008, 09:06 PM #15
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I wonder if this is what HarryZ was referring to awhile back. I would be interested in what he has to say.

Harry are you out there?
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Old 07-31-2008, 09:33 PM #16
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This is now on the Patient Information Warning Label for Tysabri.

http://www.tysabri.com/tysbProject/t...q.xml#casespml

Quote:
How many cases of PML were there in clinical trials?

PML occurred in 3 out of over 3000 patients who received TYSABRI in clinical studies. Two of the cases occurred in MS patients. They were taking TYSABRI and a beta interferon at the same time. The third case occurred in a patient with Crohn's disease who had a very weak immune system. Biogen Idec did a study of the patients who had been in clinical trials to try to find out what happened. An independent panel of experts evaluated the health records of 3116 patients. The experts found no other cases of PML.
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Old 07-31-2008, 09:58 PM #17
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Additional information:

One of the patients, the one who is hospitalized and has been on Ty for 14 months, has a history of prior disease modifying therapies including azathioprine and beta-interferons.

both patients are still alive and one has had a plasma exchange which is what the protocol is for PML.

The EU does have a modified TOUCH protocol.




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Old 07-31-2008, 10:21 PM #18
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Additional information:

One of the patients, the one who is hospitalized and has been on Ty for 14 months, has a history of prior disease modifying therapies including azathioprine and beta-interferons.

both patients are still alive and one has had a plasma exchange which is what the protocol is for PML.

The EU does have a modified TOUCH protocol.




Hi Cheryl. Thanks for the info. Where did you find it?
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Old 07-31-2008, 10:29 PM #19
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Hi Cheryl. Thanks for the info. Where did you find it?
News article. I just read everything on the internet. It is actually part of the report filed with the SEC.

http://www.sec.gov/Archives/edgar/da...14958ke8vk.htm

As for the TOUCH protocol, I've been involved with the FDA and RISK Management panels. I went back through my notes from the last conference.
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Old 07-31-2008, 11:20 PM #20
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I went to a seminar about two years ago. Of course, Tysabri risks were brought up. The neuro said they didn't expect to hear anything for 2 years or so. It was then, he said, that they expected more deaths.

I hope this is not the start of it.
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