Here's the link to the conference with all the presentations.
http://www.fda.gov/cder/meeting/riskMAPs.htm
Quote:
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.
Quote:
|
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.
Quote:
|
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.