Perhaps using the word "ease" was not correct in this situation as I didn't mean to infer that MS patients would feel comfortable.

But who is to blame about the "unbalanced view" about Tysabri? You only need to look at Biogen/Elan for causing this entire mess in the first place. That's all they had to do was follow their original plans for the trials and subsequent approval process for Tysabri. But no, they rushed everything by a full year and got caught when PML showed up and that forced them to withdraw the drug.

Even after all the subsequent studies, nobody knows for sure just how and why the two MS patients contracted PML and of course that has caused a tremendous amount of caution by the docs. And the docs will always error on the side of caution and thus many won't prescribe Tysabri at this time.

Certainly not inflation which is around 2-3% per year. And Biogen knew exactly what it was going to cost them to manufacture Tysabri. Heck, they had their entire marketing plan for the drug outlined on the internet before the drug even got approved the first time around. They had block-buster numbers for this medication which they anticipated would take over a huge chunk of the MS drug world.

No, this huge increase was to cover the extra costs of getting the drug re-approved and that took a lot of money to do so.

You can say that again!!! Those infusion costs along with the cost of the drug make Tysabri by far the most expensive drug ever for MS. That leads to a cost/benefit situation that insurance companies and government health organizations must look at and it certainly doesn't make choosing Tysabri and easy task.

Of course it cost them a ton of money to pull the drug....why do you think we saw the 21% price increase?

I will go back to my previous statement that Biogen/Elan are totally responsible for making Tysabri the controversial drug it is today. Can you imagine the different course that would have been taken if approval submission had been made AFTER the full two years of the Phase III trials? The PML cases which showed up in February 2005, before the FDA would have obtained the submission data, could have been handled differently at this point. I'm sure the fear that currently surrounds this drug would have been far less.

Harry

Harry, you seem to want to discuss the issues of Biogen and Tysabri and its fast-tracking. That I respectfully refuse to do. Thank you for your input, but my purpose was not to discuss history with regard to those issues.

The purpose of this conference was to have an open forum/workshop to discuss RiskMAPs in general and my function was as a Patient Advocate for the TOUCH protocol for Tysabri. I put up a link to the conference, feel free to comment.

If you want to discuss history regarding who did what to whom and when, that is not what I wish to do. Been there, done that.

I realize that this thread is to discuss the RiskMaps in general and of course this pertains to Tysabri's situation. You mentioned that there was unfair fear associated with Tysabri's RiskMap and I wasn't surprised to hear that.

I was merely trying to indicate why this perception exists. What's the old saying...if you want to know what is going to happen in the future, just examine the past and you'll get a pretty good idea! How appropriate if you apply this to Tysabri's current status.

Having said that, I'll refrain from taking any more shots at Biogen

Harry

http://www.fda.gov/cder/meeting/riskMAPs/bozic.pdf

Here is Biogen's presentation.