[tovaxin_lab_rat]

Thank you to those of you who answered the survey I sent out. The data collected was valuable. It helped with my presentation in ways that will help shape the future of the TOUCH program for those already enrolled and those who will be enrolled.

Many of the problems are associated with not only the enrollment process, but the drug delivery system, the insurance coverage problems, infusion appointments but the biggest problem of all, education. Education of neurologists, education of infusion site staff and education of patients. Education of the enrollment process, but most importantly, education about TOUCH, why it is important, and the reason behind why there is a RiskMAP (Risk Minimization Action Plan) attached to Tysabri. It is a safety precaution and tracking system.

One of the most common threads that we heard was the lack of positive information about Tysabri. The Medication Guide and associated educational tools are slanted towards risk. We recommended that these materials be more balanced.

Let's see if these changes are made and the promises made for better communication to the patients are kept.

[SallyC]

Thanks Cheryl, for your report. I'm glad it went well for you and I hope, right along with you that the Touch program runs a little more smoothly, in the future.

BTW, what are the positive reports. How does Tysabri seem to be working for PwMS. Are they reporting good results or not?

[AfterMyNap]

Good work, FG, it's great to have representation from someone who isn't busy organizing their own raises in pay.

Sal, most, I'd guess 90% of those I've heard from on Ty have had a lot of positive experiences with it. I can think of only two out of about 25 who feel it's not working. I haven't heard any directly negative reactions to it. Mind you, this is just from a small handful of patients with whom I communicate.

[tovaxin_lab_rat]

Sally

This wasn't that kind of conference. It was a conference to discuss RiskMAPs in general. So, I cannot really comment on that.

[DM]

Kudo's to you FG!!!! I shouldn't be surprised that you went to the conference.... Just like you to always be a front runner on trying to help others... I take my hat off to you!

Hey, who took my hat???? Hugs to ya Cheryl!

[Taffy]

Well done!!!!! So proud of you!!!!

[Harry Z]

Cheryl,

One of the most common threads that we heard was the lack of positive information about Tysabri. The Medication Guide and associated educational tools are slanted towards risk. We recommended that these materials be more balanced.

I think one of the main reasons that The Medication Guide and associated educational tools are slanted towards risk is the fact that some drug companies do a very poor job in pointing out these risks to prospective patients. After all, highlighting a risk as opposed to mentioning it in the fine print, doesn't help potential sales!

Leaving Tysabri for a moment, Teva, the makers of Copaxone, spend very little effort or time to mention the dangers of Lipoatrohpy to prospective Copaxone users. Yet this problem can occur in up to 45% of Copaxone users!
Teva has said only about 1% of the users may have this problem. Hmmm.

The Touch program has certainly put a lot of doctors and MS patients at greater ease when it comes to making a decision as whether to use Tysabri or not. While Biogen can be commended for establishing this program, I sometimes wonder if they would be running it if it wasn't connected to the FDA's re-approval of the drug. The cost must be significant and in almost every case, this cost is passed on to the patient and/or insurance company.

Keep up the good work with your efforts.....you are certainly to be congratulated.

Harry

[tovaxin_lab_rat]

Here's the link to the conference with all the presentations.

http://www.fda.gov/cder/meeting/riskMAPs.htm

Leaving Tysabri for a moment, Teva, the makers of Copaxone, spend very little effort or time to mention the dangers of Lipoatrohpy to prospective Copaxone users. Yet this problem can occur in up to 45% of Copaxone users!
Teva has said only about 1% of the users may have this problem. Hmmm.

I agree with you wholeheartedly on this about Teva. There have been many complaints about getting information about Lipoatrophy from them. I was on C for a very short time and had to quit because of severe fatigue caused by the drug. It is one of the little known side effects. Could I get them to fess up to it? Nope. Even when I spoke to the Teva Rep, nada! Each drug company is protective of their territory.

The Touch program has certainly put a lot of doctors and MS patients at greater ease when it comes to making a decision as whether to use Tysabri or not.

At greater ease? No, Harry, I respectfully disagree with you. It is scaring the hell out of a lot of them unneccessarily. Across the board, doctors and patients are getting an unbalanced view of Tysabri. That subject was discussed in great detail at this conference. And not just about Tysabri either, about drugs under RiskMAPs in general. But more so about Tysabri. If you read the Med Guide, there is no beneficial information about it in there. Nothing. It is all about risk. All the information the patient receives about Tysabri is about the risks and not the benefits.

While Biogen can be commended for establishing this program, I sometimes wonder if they would be running it if it wasn't connected to the FDA's re-approval of the drug. The cost must be significant and in almost every case, this cost is passed on to the patient and/or insurance company.

Biogen was forced to put this program in place. I have been involved in it from the very beginning. The RiskMAP and subsequent TOUCH protocol was a result of the March 2006 FDA hearings for the re-application to bring Tysabri back into the market. I was one of the 46 patients who testified and have not received one infusion of Tysabri since its reintroduction. So, you cannot call me biased towards Tysabri!

The cost of the drug went up 21%, but was that due to inflation and anticipated manufacturing costs? I heard comments from other companies that implementing RiskMAPs improves safety but not costs. One thing I can tell you is that there is no consistent cost associated with the infusions across the country. During my survey I found infusion costs from $3500 to $7500. That's just not right. I tried to get some answers from the Blue Cross Blue Shield rep at the conference but she was unable to answer any insurance questions. It wasn't her field - that befuddled several of us.

Elan/Biogen, Idec lost a lot of money when they took Tysabri off the market February 2005 and there is still one (known) pending lawsuit. Is that a factor? I have no idea about these things, but I do know that this is the cost of doing business.

Harry, bottomline, Tysabri is still a controversial medication for the treatment of MS. Its associated RiskMAP and TOUCH protocol was discussed by several of the presenters at this conference. It's a good RiskMAP/protocol. There are kinks and holes in it that must be addressed and fixed and that was what I pointed out to Biogen through my survey of patients who are in the "system." They spoke and they spoke loudly. Let's hope Biogen heard them.

[pantos]

Cheryl,

What is a RiskMAP? How does the actual RiskMAP actually aid in reducing risks to patients? I thought it was only some kind of thing where side effects are required to be reported, etc. or is that the TOUCH protocol which is different and is the reporting arm of this? But I've heard stories about people on T who appear to be having serious side effects aren't going through any special process. In fact, some are just continuing on with tx in spite of what sound like dangerous circumstances! From what I've gathered about the whole thing, it's not stringent or formal, it's pretty loosy-goosy.

If people testified at the FDA hearing (in support of the reintroduction of Ty), then they DO have an obvious bias. Why would they be involved, I assume regular every day consumers, in the development or monitoring of this RiskMAP? Wouldn't the FDA or Biogen be required to have its own PROFESSIONAL independent group responsible for overseeing this? It seems strange to me that laypeople such as yourself who only became known in any way because of their testimony at an FDA hearing to support Ty's return, are somehow involved in this process. That makes me uncomfortable. Are you being paid by someone?

I'm thinking about going on Ty. Is this RiskMAP something that would better help me make an information decision? I don't really understand your point about it highlighting the risks... obviously any doctor can access the study that shows Ty's efficacy. Isn't the whole point of this RiskMAP thing to properly characterize and delineate ALL the side effects to better gauge the risks? They are trying to make sure that people dying from Ty don't slip through the cracks like it did during the clinical trial. Aren't they?

I guess I'm a little confused by it all. And I take issue with the statement that "Biogen lost money because it was pulled". On the contrary, Biogen MADE money because it fast-tracked its little product so it could hit the market a year earlier. So it actually made money by doing so, just not as much because it had to be pulled for a while. I am annoyed that the cost of it has apparently gone up too... it already was outrageous. To think they are passing along these additional costs to the customer really irks me. They should have dropped the price to encourage customers to come back even though they forgot to properly evaluate its safety before putting it on the market to begin with. THEY should absorb these costs, not the consumers! (ok, wishful thinking I know!)

[BBS1951]

Amen Pantos.