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.