Just wanted to make a couple of points:

• Not all infusions centers in U.S. are following the required touch protocol.
• I was told at the MS center at Barnes Hospital that immuran is being widely used for ms in Europe. It was suggested as a therapy I might consider.
• Predosing with benadryl does not always mask allergic reactions to tysabri. (I know from personal experience.) I am not sure how a discussion of predosing and allergic reactions is related to PML's.

WHUH?? I guess I don't know what the big hoopla is, here. Everyone going on TY now, is made aware of the risk of PML and liver problems and infection...etc... It's on the black box.

You all voiced worry about it, when you first started it, but you are making an informed decision, when you do. Now that the prediction has, possibly, come true, is unsettling to say the least, but, not surprising.

In my mind the time to panic has passed. I paniced when TY was first pulled because of the PML deaths, and believed it should have stayed off the market.
You all wanted it back and you got what you wanted.

On the other hand, there are a bunch of lethal drugs out there, that we seem to demand......we pays our money and we takes our chances. We're all in a Trial for these drugs, we're just not gettin paid for it.:rolleyes:

I agree with you, Sally.

Everyone who has decided to use TY has done so with full knowledge.

But, it's still sad to hear that PML is once again linked to Tysabri regardless if TOUCH was followed or not.

I was trying to figure out why Cheryl thought there was an "oops" in the protocol for this patient, so I reviewed the "Patient Information Warning Label" for Tysabri that she had posted (in posting #16):

I could not find anything in the warnings that implied an "oops" may have occurred when treating this patient with Tysabri. What I did find, however, was the following warnings:

http://i12.photobucket.com/albums/a2...44/Tysabri.jpg

Why an allergy to the drug is considered a NO-GO for Tysabri, I don't know. However, they seem to think it's important enough to put it on the label (including describing what an allergic reaction might look like; hives, chills, etc.) as contradictory to using the med.

My point was, how can they know if someone is allergic, ie. if Tysabri SHOULD be a NO-GO for that person, if they are premedicating most people with antihistimines?

On that basis, couldn't every PML case be considered an "oops", since patients shouldn't even be taking Tysabri if they are allergic (according to the labeling)?

Cherie

I think it's important to keep the reality of proportion in mind when we look at this stuff. PML incidence is on the rise globally, so it stands to reason that it is on the rise for those with MS. Lower incidence rates in underdeveloped countries are attributed to their lack of diagnostic opportunities.

Those with compromised immune systems are at a higher risk for PML across the board and this has been the case since way before Tysabri and its use ever hit the scene.

This is a small section of the basic list of PML attributes from the Neurological Medicine Pocketbook for physicians published by the University of Western Ontario, Canada:

- Multifocal demyelinating lesions of CNS
- Due to reactivation of JC virus (papovavirus)
- 90% of general population have serological evidence of JC virus infection which is benign / asymptomatic
- PML occurs in association with immunosuppression (esp HIV / AIDS), leukemia, lymphoma
- The incidence of PML dramatically rose in the 1980’s with AIDs
- Up to 4% of patients with AIDs develop PML at some point during disease
- The incidence of PML has NOT changed with introduction of HAART (highly active antiretroviral therapy)
- JC virus infects oligodendrocytes, leading to lysis and demyelination


Full List:
http://www.uwo.ca/cns/resident/pocke...ection/pml.htm

As far as track records go, Tysabri is still safer at this point than Cellcept. There are 17 confirmed cases of PML with Cellcept and 6 of the cases were with people who had lupus. Why isn't there a huge public fuss in the media about Cellcept? I'm sure the same old arguments about safety v. danger with Tysabri will be hashed out in the coming days. In addition, Cellcept is being prescribed off label for MS and UT Southwestern Medical School has been doing clinical trials on Cellcept in combination with Avonex. Now we don't know what the extenuating circumstances are (maybe Cellcept was being mixed with other immunosuppresants) but the point is there appears to be a risk with some of the newer drugs coming out. And as AftermyNap says, maybe PML is also on the rise?

We got into that discussion a while back, in the following thread:

http://neurotalk.psychcentral.com/sh...hlight=Tysabri

In the case of those with HIV, they don't seem to know why those patients are ending up with PML, so the largest percentage of PML cases on record (currently) are probably inevitable. Unfortunately, AIDs often leads to an untimely death even without PML as a complication. :(

With other diseases like cancer or organ transplant, it seems like that it is the use of these strong immunosuppressants that might be causing PML. I'm not sure they have any choice in using these drugs in many cases though; it's either die (rather quickly) from the condition, or die from complications due to the meds. :confused:

With MS, and Crohn's, there are other options available, that do not include this particular risk for PML. And, from the information I posted in the above link, those options are thought to be equally effective in treating this disease.

I don't think anyone is saying that it is advisable at this point to remove this drug option . . . but I think it is important to appreciate that it seems PML can occur from Tysabri as a monotherapy. This discovery is not going to change some people's minds to try it anyway . . . but it WILL likely change others.

Cherie

Yes, I was the one who mentioned the studies going on with Cellcept and Avonex at UT Southwestern. I was asked if I wanted to participate and I declined.

You have to remember that some people have run out of options because the meds don't work or they cannot tolerate the side effects (quality of life issue). :(

Statistically, this is incorrect. CellCept, and Rituxan, have both been used on hundreds of thousands of patients, so the percentage of patients using those drugs that get PML is quite small. The problem Tysabri faces is that it might show a higher rate of PML infection among the patients taking it. There are an additional 12 cases of suspected PML in Tysabri users currently under investigation. If these turn out to actually be PML cases, then Biogen will have a very big problem...

http://tinyurl.com/5turuy

Thanks Marcstk. That makes perfect sense. You have to consider the number of cases v. number of people on the drug (and then really over a certain time period).

I tried to find more information on the 12 suspected cases in the FDA Adverse Event Reporting System (as mentioned in the article you list) but couldn't find anything. I may not be using the right search terms.