Posted: Fri Nov 26, 2004 9:11 pm
MS,
The comparison to Vioxx wasn't comparing the drug but the drug company's lack of trust in how they conducted themselves. There are experts in the field that are already questioning Biogen's information on Tysabri as being inadequate.
Please read my statement above as to what I was comparing.
The data presented by Biogen is what is being questioned. They only have one year data and some MS docs are not convinced that there is any efficacy being provided beyond one year. In fact, I was told today that there is a real concern about efficacy beyond 18 months. The people looking at this said they can't verify the data as yet because the trial data simply isn't avail.
Well, compelling data can only be verified when it is made totally available to people outside the Biogen scope and it is data from at least a two year trial. This hasn't been done yet and that's why there is concern and caution.
There are other financial situations taking place as well in Biogen involving the sale of Avonex stock by top execs just prior to Tysabri's approval. Avonex sales will likely drop off significantly now, it's orphan drug status and patent expired in 2003. There will be no cheap generic likely available since the market for it will likely disappear. Tysabri will gain a large market share and it will be sold by Biogen Idec, not Biogen. All carefully crafted in the world of business.
That's a decision for you and others to make in consultation with their doctor. But I can tell you right now that there is a lot of doubt with Tysabri and it is coming from people in the established MS world of medicine. I have my opinions about it but they are simply opinions. These people work with MS daily and when they become concerned, it certainly gets noticed soon.
Am once again feeling a little touchy because you again made a comparison to Vioxx with no just cause. There is no evidence that Tysabri (Antegren) has significantly greater side effects than those associated with the IV itself. Please look at the label.
The comparison to Vioxx wasn't comparing the drug but the drug company's lack of trust in how they conducted themselves. There are experts in the field that are already questioning Biogen's information on Tysabri as being inadequate.
Now, could it have greater side effects? Never say never. But to make the comparison to Vioxx is, in my opinion, not at all fair.
Please read my statement above as to what I was comparing.
And, in terms of efficacy, just look at the Sentinel trial. All patients were already very, very active with EDSS scores significantly above zero, and again the difference between Antegren with beta interferon and beta interferon along was extremely striking. The beta interferon was Avonex, which is the very same molecule as Rebif.
The data presented by Biogen is what is being questioned. They only have one year data and some MS docs are not convinced that there is any efficacy being provided beyond one year. In fact, I was told today that there is a real concern about efficacy beyond 18 months. The people looking at this said they can't verify the data as yet because the trial data simply isn't avail.
I don't object to caution, only the unfair comparisons and the desire to see only those possible questionable issues and to ignore the very compelling data.
Well, compelling data can only be verified when it is made totally available to people outside the Biogen scope and it is data from at least a two year trial. This hasn't been done yet and that's why there is concern and caution.
There are other financial situations taking place as well in Biogen involving the sale of Avonex stock by top execs just prior to Tysabri's approval. Avonex sales will likely drop off significantly now, it's orphan drug status and patent expired in 2003. There will be no cheap generic likely available since the market for it will likely disappear. Tysabri will gain a large market share and it will be sold by Biogen Idec, not Biogen. All carefully crafted in the world of business.
If I were diagnosed with MS today, Tysabri would be my choice and if my physician would not prescribe it then I would find a new neurologist.
That's a decision for you and others to make in consultation with their doctor. But I can tell you right now that there is a lot of doubt with Tysabri and it is coming from people in the established MS world of medicine. I have my opinions about it but they are simply opinions. These people work with MS daily and when they become concerned, it certainly gets noticed soon.