It sounds like the JC antibodies test has not been made commercial yet. In other words, it is still in a "research phase" and not available to the public. Hopefully Elan will put a rush on this if it actually works consistently.

It's because they didn't have those samples in front of them at the start and the samples had to be tested, Sal. At the time it was also believed that 90% of the world population carried the JC virus. The rate is now believed to be around 50% of the world population. It was also not easy to test for it and it was extremely time consuming and expensive. I don't believe that in a controlled trial environment, the patients names would have been attached to the samples either, just a control number.

One thing that IS happening with all this is that the science of understanding JCV and PML is being advanced and this will benefit a huge number of people, not just those with MS who are on Tysabri. It will have implications across the board, since it's been a problem with other drugs and other diseases.

IMO, Ted Yednock is a hero! His work in the field of MS treatment and now in working on this issue puts him at the very top of my list of people who deserve a Nobel prize in medicine!

Here is an article suggesting that the monitoring of Tysabri in Europe (and in particular Germany) is lax and this might be one risk factor for higher numbers of PML. Interesting.....

http://industry.bnet.com/pharma/1000...opean-doctors/

Here is the announcement of the 24th case which Riverwild mentioned to us in a previous post. Your sources are good RW!

http://www.mednous.com/news/emea-rec...linked-tysabri

Wiz, I don't get it. How can the Senior Director of Patient Services keep claiming that the risk is 1:1000 and won't acknowledge the risk is greater with more infusions? I ask this because according to this article in International Business Times Biogen people told investors on a conference call on Oct. 20, 2009 that the risk increases with a greater number of infusions.

http://www.ibtimes.com/articles/2009...data-mixed.htm

This makes me angry because it seems like they are telling investors one thing but patients another thing??

He did say the risk is more with an increase in infusions, but that even those people fall within the 1:1000. Those patients with less infusions have less risk. Sorry I didn't make that clear.

He also said that they do not recommend taking a break from Tysabri. When I asked him about the comment someone from the help center said to me yesterday, that disease activity seems to resume after about six months from stopping Tysabri, he admitted he didn't know that for sure, but that if somebody told me that from his support center, it's definitely true.

Thanks to everyone who is advocating on behalf of all Tysabri patients.

The earlier link posted by komokazi http://www.forbes.com/2009/10/27/ms-...rtner=yahootix gives enlightening information not only about the JC Virus testing being developed, but the number of PML cases and the new "odds" (1:400).

I'm getting more concerned with each passing day that we do not have 100% of the information we need to make good decisions.

I am postponing my 37th infusion in 2 weeks until after my scheduled MRI on 11/12 and a thorough and frank discussion with my neuro.

Be well,

Still don't get where anyone can come up with 1:400 odds as I posted on the other site.
I, also, still believe that 4 maybe 5 (depending where the 24th case is) cases of pml are in the U.S. which makes the odds here much better than even 1:1000 since there are, as of a couple months ago, 22,000 on Ty in the U.S.

As I was typing my Touch case manager called me. He took notes, understood all my concerns and will pass it on. He said we are being heard and the higher ups are discussing what will be done to give us information. He confirmed what I typed in the previous paragraph about how many U.S. cases and how many are on Ty.

I still think we must be vigilant and informed !!
Linda

Howdy folks!

I just woke up and I am happy to be done with work for the week! I have Saturay night off too! My DSD is having her Senior Recital that night and it is also her birthday, and I am looking forward to both!

I had a FULL box of emails today, and a full box on the answering machine, with several calls from people at Biogen. I'll let you all know what they have to say when I call them back tomorrow.

WE ARE having an effect. One of the calls was from someone high up in the company whom I haven't heard from since 2006, after the FDA hearing.

Here's what I have for new information. This information is from a trusted source who was inolved in bringing Tysabri back to market.

"The EMEA says that four (4) of the confirmed 24 PML cases have died. My contact has been quite clear that the early three cases (pre-2006) are not included in the 24 cases, but I hold out hope that the two early deaths account for half of the four reported deaths (US patient whose family declined to follow the recommended PML treatment protocol, and the recent death of the German patient reported by his wife on the German patient website). I am seeking confirmation that the four deaths are indeed all post-2006, and will update as soon as I know more. We do know that a few of the PML patients were in serious condition, so additional deaths cannot be ruled out.
-- EMEA contact does not have information concerning the relative severity of the PML patients who have survived to date. We know that some are in stable and reasonably good condition, along the lines of a severe MS relapse, but others are more serious.

-- EMEA contact reports that all 24 patients had received between 12 and 74 infusions, that 18 of the 24 cases were reported in patients who had received at least 24 infusions, and that although the data are limited, there appears to be a trend for more cases of PML to be reported with longer duration of treatment.

-- EMEA contact reports that one of the concerns of the Committee for Medicinal Products for Human Use has been to increase awareness by healthcare professionals on how to differentiate PML from a relapse of MS and the management of PML cases, and that improved awareness is of course a factor in identifying potential PML cases that can be better evaluated. This suggests to me that EMEA action will likely be limited to updated labeling, improved educational efforts among neurologist and other healthcare professionals, and possibly a TOUCH-like program that could limit the use of Tysabri in inappropriate patients.

-- I am told that as of Friday, October 23, BIIB was aware of only one recent death (I assume the recent German male patient). That means either there were two more recent deaths, that EMEA is counting the two pre-2006 deaths in its total of four, or that someone has their facts wrong.

-- I am told that BIIB believes that they need to develop a profile on a subset of patients that is more subject to PML and that the larger number of PML cases, although unfortunate, can help this effort. No surprise there.

-- BIIB is doing conference calls and visits with the largest Tysabri prescribers this week and next week to disseminate as much information as possible. There may be more information that leaks out over the next couple of days, or we may already know much of what BIIB and the EMEA are disseminating.

I have not yet gotten any breakdown, but I am sure that BIIB will be asked about that in the two conference calls with neurologists that are taking place this evening (5:00 pm and 8:00 pm ET). "

It sounds like there is still some confusion in the numbers, but the majority of patients is coming from the EU.

The EU, especially Germany, is having problems with their doctors prescribing Tysabri to patients who were on methotrexate, azathioprine, etc and not giving enough time for clearance of previous treatments. Hopefully they will get a program similar to TOUCH in place over there or improve their monitoring of patients for early PML symptoms, and learn the subtle differences between PML infection and MS relapses! Most prescribing docs here in the USA are now saying that any activity that even resembles a relapse means an automatic halt to Tysabri, MRI, urine, blood and CSF testing, monitoring, and further treatment, including PLEX and mefloquine if there is even a hint that it might be PML.

The assay developed by Ted Yednock has been sent to a commercial company for testing which will lead to production. As with everything medical, it will have to be approved by the FDA, but I think maybe there might be a fast track on this and we will hear a lot more about it sooner rather than later.

For Linda: The number of 1:400 came from Biogen. I don't have the link in front of me, but perhaps someone here still has it at hand. I will search my files and send it when I find it. My files are all jumbled from the last few weeks as you can imagine and I have to sort and prioritize them!

Wow RW. Thanks for the very useful information. I feel most optimistic about the quick production of Yednock's assay. Let's hope it will happen soon. The 1:400 risk came from Biogen? I'm quite surprised. Again, was this rate for people after 3 years?

I had infusion #17 today. The usual infusion nurse was out today (had a substitute) so I couldn't get any information. I'm still waiting for my doctor to call me back after leaving a message on Monday. That does not make me happy. It is a big clinic but really they should be care.

Anyhow, the infusion went better than usual. I came home, fell asleep for 4 1/2 hours, woke up and had just mild nausea. That's it!! This really would be the most perfect drug in the world without the PML risk. I love my Tysabri and what it has done for me (no relapses, no MS symptoms, no change on MRIs). However, my concerns about PML continue to mount and I'm not sure what I will wind up doing in the next couple of months. I'm just hoping I can get as much information as possible to make the best decision for myself.