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An FDA briefing document was released today that recommends a mandatory patient registry for Tysabri users. In August 2005 the FDA mandated an electronic registry for all patients & physicians using Accutane, and it was just announced last week that it is up and running. Hopefully a Tysabri registry won't take as long to implement.

DenverCO wrote:An FDA briefing document was released today that recommends a mandatory patient registry for Tysabri users. In August 2005 the FDA mandated an electronic registry for all patients & physicians using Accutane, and it was just announced last week that it is up and running. Hopefully a Tysabri registry won't take as long to implement.

The logistics and cost of operating a Tysabri registry will be huge! A lot of the info needed will have to be provided by the docs..some of the same docs that don't give the patients the time of day in the first place. Hopefully Biogen or whomever operates this Registry for them does the job required to make it work.

Harry

HarryZ wrote: The logistics and cost of operating a Tysabri registry will be huge! A lot of the info needed will have to be provided by the docs..some of the same docs that don't give the patients the time of day in the first place. Hopefully Biogen or whomever operates this Registry for them does the job required to make it work.

Harry, Harry, Harry. You never cease to amaze me. Tysabri is back, and large numbers of MS patients are going to benefit from it by enjoying life altering improvement in their functioning and quality of life. It's a good thing, Harry. Join us in the celebration!

As far as lazy physicians are concerned, everyone resists change to some degree, but once they get in the groove this shouldn't be that much more additional work for physicians. Did you listen to the Advisory Committee webcast? Besides that, the shift to Tysabri will be largely market driven. As word spreads among the patient community how well Tysabri works, patients will demand that their physicians prescribe it for them.

As far as the difficulty of the patient registry goes, as I mentioned the FDA just implemented the use of a registry for users of Accutane. In that case, not only will physicians have to document that they have informed the patients of the risks associated with the drug, but they also have to verify monthly that patients remain on 2 forms of birth control in order to stay on the drug. Now that sounds like addiitonal red tape for the physicians. The Tysabri registry won't be nearly as difficult for physicians to comply with.

Denver,

Harry, Harry, Harry. You never cease to amaze me. Tysabri is back, and large numbers of MS patients are going to benefit from it by enjoying life altering improvement in their functioning and quality of life. It's a good thing, Harry. Join us in the celebration!

My message had nothing to do with whether patients will benefit or not from Tysabri. We know from every single MS drug that has ever been used that some benefit and others simply do not. My comment had everything to do with the Registry that has been mentioned by Biogen and how operating a Registry of this potential size can be a logistical problem and that hopefully whoever operates it, I hope does a good job in doing so. Because monitoring MS patients who use the drug is going to be important.

We have already been told several times over that the docs are going to have to monitor each Tysabri patient for any sign of infection or early sign of PML. At the same time we have been told by many MS patients who have used the CRABs that their docs did not bother to monitor them for NABs or liver function...and this has happened AFTER the FDA demanded close monitoring for these patients. I'm really hoping that the docs who have their patients on Tysabri, don't follow in the same footsteps and get lazy down the line. We already hear complaints from many docs now about how busy they are....do you really think that these same docs will "fall into the grove"?

The easy part for Tysabri re-approval is over now. I've been saying for months the drug would get re-approved. The Tysabri supporters are happy and they should be. The opponents, especially the competitor MS drug companies, will try and find any problem they can down the line and ensure it makes the press. We've already seen these people in action just prior to the FDA hearings. When millions and millions of dollars are at issue, you can bet this struggle will go on for a very long time.

Harry

Denver,

Harry. You never cease to amaze me. Tysabri is back, and large numbers of MS patients are going to benefit from it by enjoying life altering improvement in their functioning and quality of life. It's a good thing, Harry. Join us in the celebration!

Looks like the celebration is going to be put on hold for at least another 90 days per the FDA! Am I happy...not in the least...because MS patients again are going to have to wait and wait while Biogen/Elan figure out how to establish an effective patient registry that will satisfy the FDA's safety monitoring.

Harry

Harry,
The way I read it, the decision won't necessarily be postponed for at least another 90 days, but rather the FDA can take up to another 90 days to make their decision. But whether it's 30 more days or 90 more days, those of us who are anxious to get started on Tysabri are just that...anxious.

anxious!!!!! amen to that. My daughter married and moved 8 hours away from home. We cannot go see her until HOPEFULLY, Gary's spasticity has some improvement. And there are other issues. No, we can't afford to fly with this wonderful disability payment we get each month. He stopped copaxon due to the cost and the anticipation of Tysabri.
And yes, whatever it takes, we WILL afford Tysabri. I just want Gary to take this, see if he improves any and go on living life. This limbo is killing us!