Four more cases of PML and two more deaths reported -Tysabri

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby Lyon » Wed May 19, 2010 6:18 pm

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Postby HarryZ » Wed May 19, 2010 8:13 pm

I don't understand what that means?


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.

Although noted that it's been done on veins in end stage diabetes I've yet to find that venous angioplasty has been done with any regularity in comparable situations in the past so, although I would expect the risk to be minimal, it hasn't actually been shown yet.
Bob


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

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Postby gymbuff » Thu May 20, 2010 12:38 am

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
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Postby HarryZ » Thu May 20, 2010 6:59 am

gymbuff wrote: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.

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Postby Lyon » Thu May 20, 2010 8:54 am

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Postby Frank » Thu May 20, 2010 9:04 am

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
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby Lyon » Thu May 20, 2010 9:18 am

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Postby Frank » Thu May 20, 2010 9:35 am

@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
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby chrishasms » Thu May 20, 2010 10:05 am

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.
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Postby HarryZ » Thu May 20, 2010 10:43 am

I personally feel that Tysabri is a huge improvement for some people over the CRABS but accepting Tysabri use does require accepting considerable risks. Additionally the degree of risk has shown to increase depending on location and with increasing time that you are on Tysabri.


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!

With the current alternatives in mind I consider myself a Tysabri proponent but, considering the increasing risks, three years is a long time to be on Tysabri uninterrupted in addition to problems with PML being more likely in Europe.


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.

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Postby Frank » Thu May 20, 2010 11:01 am

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

This statement is from Biogen:
The patient who died was a United States patient who had received 14 monthly infusions of Tysabri as a stand-alone treatment.

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


--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby Lyon » Thu May 20, 2010 11:11 am

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Postby Frank » Thu May 20, 2010 11:33 am

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%:
They [Biogen] went further to suggest that in their tests on the general population, the JC Virus is 50 -60% prevalent vs. the 90-95% generally accepted.

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

--Frank
Treatment: Gilenya since 01/2011, CCSVI both IJV ballooned 09/2010, Tysabri stopped after 24 Infusions and positive JCV antibody test, after LDN, ABX Wheldon Regime for 1 year.
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Postby HarryZ » Thu May 20, 2010 1:01 pm

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

--Frank


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

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Postby Lyon » Thu May 20, 2010 6:35 pm

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