This Is MS Multiple Sclerosis Knowledge & Support Community

And the count continues to rise more quickly than ever with 11 more cases of PML...now up to 323. Don't know if any more deaths are involved.

http://chefarztfrau.de/?page_id=716

Harry

Thanks for the link, Harry.

Many of those who don't die from PML are left with truly awful disability--I met and talked with a survivor of PML due to Tysabri. If my "MS" is still active after I have spinal surgery for cervical bone spurs and a 2nd CCSVI PTA (enjoyed two years of symptom improvements), I might start Aubagio, but I'm afraid that PML will raise its ugly head with this drug just like it did with the others and possibly with BG-12, also.

As you know, we need highly selective agents that only target the part of the immune system that's causing problems instead of agents that destroy most, if not all, of the immune system. You might find this article interesting:

http://www.thisisms.com/forum/chronic-c ... 21543.html

I know three hundred sounds like a lot but with something like fifty thousand people r
Treated with tysabri it really is not very prevalent.

Bender wrote:I know three hundred sounds like a lot but with something like fifty thousand people r
Treated with tysabri it really is not very prevalent.

Unless you are one of the 323 who came down with PML!!

It's not just PML that's an issue here, it's the way that Biogen handled Tysabri's introduction and the immergence of PML.

It started off with MS patients being told that Tysabri was very safe. Then 2 initial cases of PML caused Biogen to pull the drug temporarily. They then told us that you could only get PML if you took Tysabri with another immune-modulating drug. Then only if your system wasn't cleansed from that type of drug. Then Tysabri was safe it you used it as a monotherapy. Then only if you had the JC Virus. And the risk was only 1:2000, then 1:1000 and now it's less than 1:500.

It's risk factor continues to grow the longer you use the drug and who knows what lies ahead.

Harry

but, yet the fda and ins. will continue to do what they do. and, when it comes to say chiro. or massage or dental adj. natural things that help and do no harm they back off and you pay out of pocket. "if you can". if there was even 1 death that was even remotely associated with a death while useing these things it would be played up big time. but, "323" lives lost and as happy poet said the ones that live are a mess--well hell that shouldn't put up a big red flag. they know people desperately want help and some are willing to play the odds. medicine is supposed to be about healing not russian roulette.

blossom wrote:but, yet the fda and ins. will continue to do what they do. and, when it comes to say chiro. or massage or dental adj. natural things that help and do no harm they back off and you pay out of pocket. "if you can". if there was even 1 death that was even remotely associated with a death while useing these things it would be played up big time. but, "323" lives lost and as happy poet said the ones that live are a mess--well hell that shouldn't put up a big red flag. they know people desperately want help and some are willing to play the odds. medicine is supposed to be about healing not russian roulette.

It's called "The Established World of MS Medicine". Sigh!

Harry

Let the reign of terror continue .

While I'm rarely one to stand up for the drug companies, and routinely pillory Big Pharma on my blog, Tysabri has dramatically impacted many patient's lives for the better, so much so that those who benefit from it are loathe to come off of it even if they eventually test JC positive. Considering the destruction that can be wrought by aggressive MS, and the turnaround that many patients experience after taking Tysabri, the risk of PML seems, to them, to be worth it. Furthermore, as more is learned, doctors are becoming more sophisticated in their use of the drug. Many are not prescribing it for patients who are JC positive, and for those who are JC negative the risk of PML is quite negligible.

Again, I don't trust big Pharma as far as I can spit, and I think some of Biogen's business practices are despicable, if not downright unlawful, but Tysabri has been responsible for the dramatic improvement in quality of life for many patients taking it. Remember, it was MS patients who lobbied the FDA to reinstate the drug, although biogens malfeasance and obfuscation surrounding the true risk of PML was and is deplorable.

As with all things MS, it's a complicated issue…

marcstck wrote:While I'm rarely one to stand up for the drug companies, and routinely pillory Big Pharma on my blog, Tysabri has dramatically impacted many patient's lives for the better, so much so that those who benefit from it are loathe to come off of it even if they eventually test JC positive. Considering the destruction that can be wrought by aggressive MS, and the turnaround that many patients experience after taking Tysabri, the risk of PML seems, to them, to be worth it. Furthermore, as more is learned, doctors are becoming more sophisticated in their use of the drug. Many are not prescribing it for patients who are JC positive, and for those who are JC negative the risk of PML is quite negligible.

Again, I don't trust big Pharma as far as I can spit, and I think some of Biogen's business practices are despicable, if not downright unlawful, but Tysabri has been responsible for the dramatic improvement in quality of life for many patients taking it. Remember, it was MS patients who lobbied the FDA to reinstate the drug, although biogens malfeasance and obfuscation surrounding the true risk of PML was and is deplorable.

As with all things MS, it's a complicated issue…

Yes, many MS patients have benefitted from Tysabri but over the years but so have patients who have used Betaseron, Avonex, Copaxone and Rebif. The efficacy rate of the CRAB drugs has been quite debatable though and the efficacy of Tysabri doesn't appear to be as high as Biogen initially told us. And the long term use of this drug is one big question mark at the moment.

What I really object to is how Biogen introduced Tysabri and the marketing/sales gimmicks they have used despite not being aware of the safety issues. I guess time will tell on how well the drug works and how many people become very sick while using it.

Harry

In case you guys are interested, people have attempted to do a quantitative cost-benefit analysis of tysabri use vs other disease modifying agents.

check out this source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2676947/

Of course, the article doesn't take into account the fact that risk with very long term use is still unknown.

The point still remains, this is a drug with 90% benefit in Gad + MRI brain lesion, 66% benefit in clinical relapses with relatively good tolerability. To some extent, JC virus serum elisa can stratify risk of PML (though there is a approximately a 2%/year conversion rate from seronegative to seropositive).

If you have aggressive relapsing remitting MS, your chance of significant disability over the long run is fairly high, so the drug probably has a net average benefit, even considering the small risk of a devastating complication.

Of course, the article doesn't take into account the fact that risk with very long term use is still unknown.

This info is almost 5 years old. Since that time the risk of PML has gone from 1:1000 to 1:300 after 2 years of use. That's about 1/2 way to neutralizing the effect over Interferon and not counting the additional infections and a other side effects that Tysabri has demonstrated. I guess one can use stats to try and prove almost anything.

Harry

Just noticed this morning that the PML cases have gone up to 347 which represents an increase of only 4 in the past month. Hopefully this level of increase will start to reduce.

http://chefarztfrau.de/?page_id=716