Comments on: Biogen May Have A New Tysabri Problem http://www.pharmalot.com/2008/02/biogen-may-have-a-new-tysabri-problem/ News, Comment and Conversation Fri, 10 Feb 2012 18:48:10 +0000 http://wordpress.org/?v=2.6.2 By: www.worldpharmanews.net http://www.pharmalot.com/2008/02/biogen-may-have-a-new-tysabri-problem/#comment-146210 www.worldpharmanews.net Fri, 08 Feb 2008 13:01:30 +0000 http://www.pharmalot.com/2008/02/biogen-may-have-a-new-tysabri-problem/#comment-146210 <strong>Pharmalot » Biogen May Have A New Tysabri Problem...</strong> A letter to the New England Journal of Medicine details two dramatic, but potentially cautionary tales about Tysabri. A 46-year-old woman with MS received her first dose of Tysabri; thereafter her melanoma spreads like wildfire. A 45-year-old woman wit... Pharmalot » Biogen May Have A New Tysabri Problem…

A letter to the New England Journal of Medicine details two dramatic, but potentially cautionary tales about Tysabri. A 46-year-old woman with MS received her first dose of Tysabri; thereafter her melanoma spreads like wildfire. A 45-year-old woman wit…

]]> By: Bryan http://www.pharmalot.com/2008/02/biogen-may-have-a-new-tysabri-problem/#comment-145100 Bryan Thu, 07 Feb 2008 19:46:40 +0000 http://www.pharmalot.com/2008/02/biogen-may-have-a-new-tysabri-problem/#comment-145100 Maybe Carl knows that the participant in the clinical trial who got melanoma was on placebo not Tysabri (see the answer to the question from Michael Alberman of Credit Suisse): http://seekingalpha.com/article/63415-biogen-idec-inc-q4-2007-earnings-call-transcript?page=7 Maybe Carl knows that a Tysabri safety trial wraps up this month, and will reveal safety data for Tysabri patients, some of whom will have been on therapy for 2 years as of March, so far with no PML cases: http://clinicaltrials.gov/ct2/show/NCT00306592?term=tysabri&rank=4 Maybe Carl knows that no patient on Tysabri monotherapy has developed PML and that the often mentioned 3 PML cases were patients who were on multiple therapies, at least one of whom was on known PML causing drugs such as Azathroprine and Remicade? Maybe Carl believes that the TOUCH program used with Tysabri will keep heavily immunocompromised patients away from Tysabri and limit if not eliminate the possibility of PML? (Although if you are immunocompromised for other reasons and you decide to take Tysabri, how do you decide whether the PML is caused by Tysabri?) Maybe Carl knows that other MS drugs have their own side effects and that the efficacy of Tysabri for relapsing patients is worth the risk? Maybe that's why Tysabri is the only MS therapy in the UK approved for reimbursement? Maybe Carl thinks that the NEJM letter to the editor was important in terms of making sure doctors are advising their patients to note changes in the appearance of moles, but that using anecdotal reports when the original clinical trials showed that melanoma in the Tysabri and Placebo groups was comparable (mostly, there was the one patient on placebo who died) is not rational, but certainly something to follow? Maybe Carl knows that the participant in the clinical trial who got melanoma was on placebo not Tysabri (see the answer to the question from Michael Alberman of Credit Suisse):

http://seekingalpha.com/article/63415-biogen-idec-inc-q4-2007-earnings-call-transcript?page=7

Maybe Carl knows that a Tysabri safety trial wraps up this month, and will reveal safety data for Tysabri patients, some of whom will have been on therapy for 2 years as of March, so far with no PML cases:

http://clinicaltrials.gov/ct2/show/NCT00306592?term=tysabri&rank=4

Maybe Carl knows that no patient on Tysabri monotherapy has developed PML and that the often mentioned 3 PML cases were patients who were on multiple therapies, at least one of whom was on known PML causing drugs such as Azathroprine and Remicade?

Maybe Carl believes that the TOUCH program used with Tysabri will keep heavily immunocompromised patients away from Tysabri and limit if not eliminate the possibility of PML? (Although if you are immunocompromised for other reasons and you decide to take Tysabri, how do you decide whether the PML is caused by Tysabri?)

Maybe Carl knows that other MS drugs have their own side effects and that the efficacy of Tysabri for relapsing patients is worth the risk? Maybe that’s why Tysabri is the only MS therapy in the UK approved for reimbursement?

Maybe Carl thinks that the NEJM letter to the editor was important in terms of making sure doctors are advising their patients to note changes in the appearance of moles, but that using anecdotal reports when the original clinical trials showed that melanoma in the Tysabri and Placebo groups was comparable (mostly, there was the one patient on placebo who died) is not rational, but certainly something to follow?

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