Comments on: Biogen’s Tysabri Linked To Liver Damage http://www.pharmalot.com/2008/02/biogens-tysabri-linked-to-liver-damage/ News, Comment and Conversation Fri, 10 Feb 2012 17:56:12 +0000 http://wordpress.org/?v=2.6.2 By: E E Wear http://www.pharmalot.com/2008/02/biogens-tysabri-linked-to-liver-damage/#comment-224863 E E Wear Mon, 24 Mar 2008 22:08:21 +0000 http://www.pharmalot.com/2008/02/biogens-tysabri-linked-to-liver-damage/#comment-224863 I have been on Tysabri now for about a year. I feel I`ve become an addict. The stuff works! I was delayed once by about 10 days, wow! the MS symptoms exasperated rapidly, It took 2 more infusions to recover the loss. I feel if I ever go off it now the battle is over. WHOLESALE was stated to be around $2200 per dose.My ins. is billed over $4000.The cost is going to kill me not the Rx. The Kermudgen..... I have been on Tysabri now for about a year. I feel I`ve become an addict. The stuff works! I was delayed once by about 10 days, wow! the MS symptoms exasperated rapidly, It took 2 more infusions to recover the loss. I feel if I ever go off it now the battle is over. WHOLESALE was stated to be around $2200 per dose.My ins. is billed over $4000.The cost is going to kill me not the Rx.

The Kermudgen…..

]]> By: Tom http://www.pharmalot.com/2008/02/biogens-tysabri-linked-to-liver-damage/#comment-182061 Tom Thu, 28 Feb 2008 15:50:54 +0000 http://www.pharmalot.com/2008/02/biogens-tysabri-linked-to-liver-damage/#comment-182061 Note that the warning is based on reports on high LFTs plus bilirubin (a predictor of liver damage), not on actual cases of hepatotoxicity. It seems to me that this news is a good example of the FDA's safety surveillance program working as it should. There was early evidence of a potential problem, it was scientifically evaluated, and a proper warning was communicated. Note that the warning is based on reports on high LFTs plus bilirubin (a predictor of liver damage), not on actual cases of hepatotoxicity. It seems to me that this news is a good example of the FDA’s safety surveillance program working as it should. There was early evidence of a potential problem, it was scientifically evaluated, and a proper warning was communicated.

]]> By: ol cranky http://www.pharmalot.com/2008/02/biogens-tysabri-linked-to-liver-damage/#comment-181170 ol cranky Thu, 28 Feb 2008 02:19:53 +0000 http://www.pharmalot.com/2008/02/biogens-tysabri-linked-to-liver-damage/#comment-181170 Elan's clinical development is notoriously crappy - the quality of work/CRO oversight and overall study management would be considered sub par by Medical Affairs people working on Registry studies. Sadly, this really doesn't surprise me coming from any product in which Elan played any part in the clinical development process. Elan’s clinical development is notoriously crappy - the quality of work/CRO oversight and overall study management would be considered sub par by Medical Affairs people working on Registry studies. Sadly, this really doesn’t surprise me coming from any product in which Elan played any part in the clinical development process.

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