This Is MS Multiple Sclerosis Community: Knowledge & Support

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We know what Biogen's efficacy data was for the Tysabri trials which were conducted on mild cases of MS with low EDDS numbers. I haven't seen any data for the general public who have been using the drug since that time.



Have a look at this Youtube link...it may answer some of your questions. It's in 2 parts.

http://www.youtube.com/watch?v=2bt8Kqb6 ... r_embedded

Harry

Sorry to go back to this issue again but am I being naive in thinking that blood tests and meeting the doctor/neurology team every 4 weks is some sort of protection against PML. Surely if the signs and symptoms are spotted early enough death or serious health deterioration can be mitigated or eliminated.
Can anybody please shed some light on the issue for me.
TIA

I don't think they really know enough about PML as yet to give us any definitive answers to your question.

Prior to Tysabri's introduction, PML wasn't much of a concern to the medical world because it showed up so rarely. But that has all changed and Biogen has been scrambling ever since to learn as much as possible about it. Their incentive?....PML is affecting their bottom line, big time, in the sale of the drug.

One thing for sure....you really don't want to get PML regardless of how early it is detected.

Harry

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As a 24 month Tysabri user I am glad that Tysabri is available. I didnt have any relapses during that time and the once in four weeks infusion interval was much more comfortable for me than the daily Copaxone shots which I didnt tolerate well. Besides minor headache on the day of administration I didnt experience any side effects.

@Lyon: I dont think that the local distribution of PML cases should be taken too seriously when considering Tysabri and the potential PML risk. What could be the relevant difference between Europe (and Germany in particular) compared to the US, anyway?

--Frank

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Treatment: CCSVI both IJV ballooned 09/2010, No DMDs, Tysabri on hold after 24 Infusions, after LDN, ABX Wheldon Regime for 1 year.

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@Lyon:
There have been PML death in the US, too.
You can find a list with some details of the 52 PML cases here:
http://chefarztfrau.de/?page_id=418
Its a German report but I guess you will be able to get the basic information out of it. If you needed any help with a translation, I would be glad to help.

Regarding the disparity between Europe and the US I cant see how a a difference in care could make a difference. We all get the same drug and cant do anything to prevent PML so its just about detecting it ASAP.
So it might be that PML does not have such a devastating effect in the US because of more diligent care, but the imbalance (EU, US) is also obvious in overall PML cases not only severity.

My neuro once told me that after approval of Tysabri Europe was very quick in bringing it to bigger numbers of MS patients. So it might just be that Europe has a longer treatment record per patient than the US and because the PML risk rises with duration that might be a point.

--Frank

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Treatment: CCSVI both IJV ballooned 09/2010, No DMDs, Tysabri on hold after 24 Infusions, after LDN, ABX Wheldon Regime for 1 year.

Well I know the valididty of German press but I do know Dr. John Corboy and Vollmers say there has been no deaths in the USA according to them. Do some research into how into things they are. No slouches. If there are some deaths in the US they have no idea. Please read my previous post. PML really isn't that prevalent.

The thoughts they gave to me is some THEORIES as to why it may be but they all had reasons why these couldn't be as well...

1. They smoke way more in Europe, and in close quarters. Does the extra cancer sticks relate?

2. WWI & WWII...something left over in the soil? Especially in Germany, there was some serious fighting in and near Berlin w/ Russia.

3. Richer diet...as MS folk here tend to watch the diet closer...I guess.

Just some thoughts.

With once every 4 week infusion and fewer side-effects than the CRABs, that in itself is a large improvement. The risks of Tysabri are becoming known more and more as more people use the drug. It's too bad that the MS patient is being used to determine this since minimal research was done on long term use prior to the drug being approved.

I can remember the comments from many neuros when Tysabri first became available. They trashed the CRAB drugs a lot, stating their effectiveness had been largely over-stated and the side effects were very damaging to MS patients. Then PML arrived and these same neuros had to place their patients back on the CRABs!



Yep, the MS patient world still really doesn't have a decent viable treatment for MS that doesn't have some major problem with it. That's what happens when you play with the immune system with these powerful drugs.

Harry

@Chris:
Then it seems as though Dr. John Corboy and Vollmers are not that well informend.

This statement is from Biogen:

http://www.forbes.com/feeds/afx/2008/12 ... 45865.html


--Frank

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Treatment: CCSVI both IJV ballooned 09/2010, No DMDs, Tysabri on hold after 24 Infusions, after LDN, ABX Wheldon Regime for 1 year.

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Just a comment to Lyons point no. 1.:

In this post - http://www.thisisms.com/ftopic-9857-previous.html - it was stated that biogen has evaluated the prevalence of JCV to be 50%-60%:

Of course one has to keep in mind that Biogen has an interest to make Tysabri/PML/JCV look as harmless as possible.

--Frank

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Treatment: CCSVI both IJV ballooned 09/2010, No DMDs, Tysabri on hold after 24 Infusions, after LDN, ABX Wheldon Regime for 1 year.

And that's exactly how they portrayed it in a recent webcast which got them into a lot of hot water with the FDA.

Harry

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