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

MSUK · Post by **MSUK** » Fri Apr 16, 2010 6:52 am

Four more cases of PML and two more deaths reported for Tysabri - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1905

dino84 · Post by **dino84** » Fri Apr 16, 2010 11:20 am

Brainteaser · Post by **Brainteaser** » Fri Apr 16, 2010 7:10 pm

Neuro logic - 'My 11 Tysabri deaths are not as bad as your possible 1 CCSVI death.'

HarryZ · Post by **HarryZ** » Sat Apr 17, 2010 7:35 am

Brainteaser wrote:Neuro logic - 'My 11 Tysabri deaths are not as bad as your possible 1 CCSVI death.'

Like I've said in the past, the World of MS medicine, together with the NMSS, have circled the wagons and are doing their very best to suppress CCSVI. It is being considered as threat to their long established beliefs and treatment of MS.

Harry

HarryZ · Post by **HarryZ** » Sat May 15, 2010 6:17 am

3 more cases of PML.

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screamner · Post by **screamner** » Tue May 18, 2010 8:20 am

now 52 cases

chrishasms · Post by **chrishasms** » Tue May 18, 2010 9:27 am

My doctor just told me some interesting facts on PML and Ty.

1. No one has gotten the disease until after 1 year at least of use.

2. It is closer to 65 total people have gotten PML, and only around 15 have died. That is out of close tov60,000 people on it.

3. Of the 15 or so who have died, 11 of them actually banked their blood. In the people who died, they found the JCV virus in the blood.

4. All of the people at my site are now going under testing for the virus as they think it is the fore runner to PML.

5. All of the deaths have been overseas.

6. Now when PML is expected, they instantly do a Plasma exchange to flush Ty from the body and it seems to be the right way to treat it.

7. The new oral drug has caused a couple of deaths in testing as well so there is nothing besides Ty, or HiCy for extremely aggressive MS. By the end of the year you will also have the new oral drug out - which has killed in trials.

So there you go. Three treatments for extremely aggressive MS and they have all killed someone. However, I from experience will tell you aggressive MS that responds to nothing is not even close to living.

So if you are not living anyhow, well, what do you have to use or loose?

I also do not understand is how we can have a disease that is just as serious as cancer yet no one wants to treat it as aggressively. Last time I checked the drugs for cancer couldn't magically cure anything via a pill and there is a mortality rate with Cancer drugs higher than MS drugs.

I am not understanding the something for nothing attitude w/ the disease. I know someone who has been on Ty for 8 years clear through the trials and are fine so there are many many many people more who have a whole bunch of success on these "killers" than don't.

With Ty that is a PML rate of .0008667% The actual mortality rate is .00025% I believe Open Heart surgery is worse odds. Now this is my doctor who is in charge of all research at Anschutz saying these numbers.

Now the mortality rate of those who got PML is close to 30% and that is a horrid number of course!!

Now all these numbers are ballpark numbers. If you really want to tear it down and go through all the trouble to get exact numbers that will still make my math extremely close, go ahead...I just don't have the time.

It's not that bad folks!!

HarryZ · Post by **HarryZ** » Tue May 18, 2010 9:51 am

It's not that bad folks!!

Unless, of course, you are one of the patients who comes down with PML!

It's too bad that Biogen rushed this drug into use instead of taking the time to test it properly and get a better handle on PML. And even today, they minimize the dangers of getting PML and have the FDA on their back for doing so.

Like any drug, one has to balance the benefits and risk...and the PML risk of Tysabri appears to be rising.

Harry

sou · Post by **sou** » Wed May 19, 2010 9:04 am

chrishasms wrote:Now the mortality rate of those who got PML is close to 30% and that is a horrid number of course!!

If I were on Ty and got PML, I 'd rather die, because the condition after that would be worse than a nightmare.

I think that Ty has been released to the market tested on RR MS with low EDSS scores.

sou

gymbuff · Post by **gymbuff** » Wed May 19, 2010 10:10 am

I am into my third year on Tysabri and my quality of life has improved while on the drug. I get my blood tested and see my neurology team every 4 weeks. I am quite happy in the belief that if anything appeared wrong the hospital authorities/neurology team would spot it before it became a major issue. Am I naive to think that the monthly blood check etc. is adequate protection and if PML did get into my system that it would be caught in time before any major damage was inflicted on my already damaged body.

HarryZ · Post by **HarryZ** » Wed May 19, 2010 11:38 am

I think that Ty has been released to the market tested on RR MS with low EDSS scores.

sou

That's exactly how Ty was tested before it was released the first time and it got the fast track from the FDA after one year of the two year Phase III trials.

Had they waited the full 2 years of Phase III trials, those first 2 PML cases would have been discovered before approval and who knows what course the drug would have taken at that point.

If you can remember when the CRAB drugs came out in the early 90's...the docs and drug companies showed us chart after chart on how well MS patients were doing in the first 5 years on these new drugs. Then the truth set in and we know the results after that. Not sure what will happen with Ty after 5 years of stats but at least with the CRABS we didn't have PML.

Harry

Lyon · Post by **Lyon** » Wed May 19, 2010 12:25 pm

sou · Post by **sou** » Wed May 19, 2010 4:04 pm

Does that make Ty safer or more effective?

Lyon · Post by **Lyon** » Wed May 19, 2010 4:53 pm

HarryZ · Post by **HarryZ** » Wed May 19, 2010 4:58 pm

Lyon wrote:An important distinction that everyone seems to be ignoring is that Ty has shown and documented patient benefit, where with CCSVI elimination not enough people haven't been studied with enough accuracy to have shown accurate risk/benefit ratio.

Hi Bob,

I don't think people in general are ignoring Ty's documented benefit. I'm not sure yet if the trial data that Biogen gave us translated into the same numbers for general public use. Not sure if you remember the CRAB patient benefit that we had thrown at us for the first 5 years of its use and then it went all down hill after that. A few sites in North America are working on the CCSVI theory and it's going to be several months yet before we get any meaningful data.

It's not really fair or accurate to think that 1 death and 1 serious complication is preferable to Tysabri's record if it's found in the end that CCSVI elimination holds no health benefit at all for people with MS.

The risk of CCSVI is already known since it is a procedure that has been done for many years...with very minimal risk and/or complication. What isn't known yet is the benefit to MS patients.

Harry