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Old 11-27-2006, 05:28 PM #7
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kingrex kingrex is offline
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kingrex kingrex is offline
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Join Date: Sep 2006
Location: South Florida
Posts: 97
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Quote:
Originally Posted by Harry Z View Post
I'm afraid I will have to respectfully disagree with you on the Crohn's patient who was indeed on a monotherapy with Tysabri. He had stopped using Infliximab 20 months earlier and hadn't used Azathioprine for 8 months. He was in generally good health (other than from the typical symptoms from Crohn's which he endured for 28 years) and went fishing and hunting.

The JC virus only appeared in his blood during his monotherapy Tysabri use between Feb-June 2003. In one NEJM article, the reps from Biogen/Elan state they asked the physicians who controlled the trial to review his case while in their own article, the physicians say they informed Biogen/Elan first, after knowing about the 2 MS patients who contracted PML!

The family of the Chron's patient was never originally informed about the cause of his death although the Biogen/Elan and the docs knew and stated such in the NEJM article. The family was informed by their doc in April 2005 and then told about the PML cases. The family ran up against roadblocks from the trial docs and Biogen/Elan when they asked to review the all the medical files. When they finally succeeded in being able to do so they were told "try not to make a big fuss about this"!!

This is another reason why I don't think we are being told everything by Biogen/Elan and the docs when it comes to Tysabri and PML. Biogen/Elan have been hanging their hat on the fact that PML did not occur in any monotherapy with Tysabri. The Crohn's patient situation looks like this isn't likely the case.




Have you noticed that the talking heads who were so visible prior to Tysabri's re-approval have disappeared? Maybe, once there was no chance of queering the re-approval, the hired guns lost interest in the "safety profile" of Tysabri? You seem to be the last guy carrying the banner.
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