Dear Pantos

RiskMAP = Risk Minimization Action Plan. There are many drugs that are under these types of plans, not just Tysabri. A RiskMAP is a guide whereby these drugs are watched carefully by several agencies on how they are dispensed, tracked, prescribed, alert/warnings issued, stored, and several other factors. Each RiskMAP is different and individual for each drug. There is no standardized RiskMAP or boiler plate form that can be pulled up from the internet to look at when writing one for a new drug, or for writing one for a drug that has been on the market that has been determined now to need one. Each one is specialized for that drug.

Lotronex, Accutane, Bactrim/Warfarin, Thalomid (Thalidomide), Dofetilide, Clozapine, just to name a few, but currently there are at least 30 and probably more, all have RiskMAPs. Some more stringent than others. Some with associated protocols such as stickers, black box warnings, some have stops, and some with mandatory testing before you can receive the prescription.

TOUCH is the distribution program designed to assess the risk of PML, to track any potential cases of PML and any other adverse events, and to promote informed benefit/risks associated with the decision making process for the use of Tysabri. It also contains the educational program for the training of the mandatory enrollment of patients, neurologists, pharmacists, and infusions centers.

DISCLAIMER: I am not paid by anyone. I do not receive Tysabri. I am in a clinical trial for Tovaxin which is in phase IIb trials by Opexa.

Some of the patients with MS who testified back in March 2006 were there to let the FDA know that we wanted a choice of drugs to treat MS. That was the sum and substance of my testimony. Be careful of making assumptions.

If you are considering Tysabri, I think you would be more informed about the drug. If you were, you would know the answers to the questions you are asking.

Yes, every doctor CAN access the latest efficacy information about Tysabri. The problem is that some don't. The lastest article came out in this week's NEJM. Ask your neuro if s/he has read it.

This conference pointed out that the med guide and TOUCH protocol for Tysabri DID IN FACT, only give the risks. It did not contain the benefit information for the patient to read. That is a fact. Not something I made up just to put words in a post. It is not something I said, it was something that others brought up at this conference.

Read the link I posted, you might find it interesting.

I take exception to this as well. I also included Elan in this, not just Biogen. Elan is the original holder of the patent on this drug. Biogen/Idec holds the US sBLA on the drug. Yes, they all lost money. The stock dropped a significant amount. But that wasn't my point. If you think it is, then you are missing my point completely. Wishful thinking? You bet. It irks me as well. (And Elan/Biogen voluntarily pulled the drug.)

All drugs are expensive. Why is provigil so expensive? Tell me that? I take it every day and cannot for the life me understand why this drug is so damn expensive.

Thanks, Cindy. I appreciate your answer. I just haven't heard too much since Tysabri started back up. I heard wonderful stories, when it was first out and now...not much.

I assumed that the hype was bigger than the bite. In other words, Tysabri is just another MS Modifying Med. and not any closer to a cure than the rest of them.

Considering all this, the expense is rediculous and sinful. They should be ashamed. I hope that in the near future, a cure or at least something to stop MS in its tracks, will be found.

I've given up, for it to happen in my lifetime, but I hope it will happen in yours.

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.