I called Active Source today. My phone call lasted over 1 1/2 hours and I still don't have any information. I did ask that the call be recorded.

I spoke to a case manager, a team leader and a therapy support manager. Everyone was very polite and apologized for not having any information for me. I asked all of the questions that RW suggested. They kept trying to convince me that the ratio for PML is still 1 in 1,000. I insisted that the ratio may be much smaller depending on how long the 10 new cases of PML had been on Ty. Finally, the team leader understood. She said she would inform Leader Management of all of my concerns. If she receives any information from Management she will call me back. I informed everyone I spoke with that I am seriously considering stopping my infusions. Stress is not good for m.s. and I have been very stressed since Friday


Ty has been wonderful for me. I'm out of a wheelchair, using my hands again and much more independent. But, when I couldn't have an infusion for 14 weeks this summer due to illnesses unrelated to m.s. I began to lose the progress I had made. So, I know what will happen to me if I stop my infusions. But, being in a wheelchair, having limited use of my hands and being dependent on my husband is better than PML!!!!!!!!!!!!!!!!!!

Everyone asked if I had spoken to my neuro. I called her this morning and left a message with the nurse...my neuro doesn't work on Mondays. I'll hear back from her tomorrow. But, since I'm leaving for California tomorrow to visit my daughter and grandchildren it may be Wednesday before I actually speak to my neuro or the nurse again. I doubt that my neuro will have any info yet because the drs seem to get the info at the quarterly meetings and the next meeting isn't until sometime in September. Even then how much info she has will depend on how much Biogen is telling the FDA and the drs.

I mentioned during my phone call to Biogen that I was feeling like a cash cow. Biogen was only interested in PML because the more cases that are reported the more likely patients will stop taking Ty. Everyone insisted that my perception was incorrect but that they could see why I was feeling this way if I receive all of my information from Wall Street instead of through Biogen.

My next infusion is scheduled for November 6. At this point I seriously doubt I will be at the infusion center that day. I love what Ty has done for me but I have already had 26 infusion. At least I think that's the number...I've lost track

oops......that should have been December not September...LOL

I am definitely stressed

I feel the same as you Shayna. Why should we be stressed over this? We're the ones paying for the drug and taking all the risk. We deserve to know the details about the PML cases and how they can affect us.

I'll stop it and go back to Copaxone and wait for an oral med to be approved. I don't need to deal with them if they're withholding information. I would consider Avonex as well but would have to discuss that with my neuro.

I can put up with the shots if I have to, they're easier to deal with than PML.

Ok, here's what I have so far. Please remember that this is the internet and the information has been gleaned on the net and I cannot verify the facts, since Biogen is giving us nothing, but I know the person who reported this personally and consider them a trusted source.

The number confirmed is now 24, with a new case coming in over the weekend, according to a person who spoke with the FDA today. The FDA confirmed that this number is the number of cases since Tysabri was returned to market in the EU in 2006. It sounds like most of the new cases are in the EU, but reports are coming out that two or three are in the US in large MS clinics. Reporter also says one patient is home after a week of rehab and in her case so far she is not much worse than she was before PML.

The person who reported this conversation with the FDA spokesman today also reports that Biogen medical liasons(not salespeople) will be meeting with neurologists in the larger prescribers to update them. I am thinking that this means all prescribers will be getting a visit or a call if they are in more rural areas like my neuro is. I think most prescribers know the benefit of Tysabri and are not scared about the new numbers. They have the expertise and the testing in place to monitor patients closely and the patients in the US are under TOUCH and seem to be more vigilant and aware of what to watch for and report to their neurologist when they suspect something.

At least one of the patients developed PML two months after starting a drug holiday. It is thought that the chance of PML decreases with drug holidays but the chance of disability progression and damage due to relapses increases when you are off any drugs to treat MS, so it's a tradeoff that each person has to assess for themselves with the information they find. You also stand a chance of developing antibodies and having a lesser rate of efficacy when you restart therapy with Tysabri after drug holiday, and that is a concern for many patients. Lauren Roberts made a good point in which she reminds us to read page 6 of the Tysabri label that comes with every vial (and you should ask for it at every infusion! I get the empty vial, the box and the contents so I can track numbers and dates):

"Experience with monoclonal antibodies, including TYSABRI, suggests that patients who receive therapeutic monoclonal antibodies after an extended period without treatment may be at higher risk of hypersensitivity reactions than patients who received regularly scheduled treatment. Given that patients with persistent antibodies to TYSABRI experience reduced efficacy, and that hypersensitivity reactions are more common in such patients, consideration should be given to testing for the presence of antibodies in patients who wish to recommence therapy following a dose interruption. Following a period of dose interruption, patients testing negative for antibodies prior to re-dosing have a risk of antibody development with re-treatment that is similar to TYSABRI naïve patients"...

I am still on the side of no drug holiday. I trust my doctor and he trusts me to be vigilant. For me, the chance of further disability that I KNOW will occur if I am not on Tysabri outweighs the fear of PML at this point and so far after 31 infusions, I am doing VERY well. I am not saying I won't change my mind, but I need information when it comes up, not when Biogen decides that I need it, and that is why I am hounding Biogen to update US! I'm not afraid to skip a dose and remove some $$ from Biogen's pocket if that is what it takes to get some information, since I have already missed an infusion back in February and had no adverse effects.

I'm also keeping in mind that the competing drug companies have already fed false and misleading information to reporters since Tysabri was first introduced to market, and again when it was returned to market, (including reporting that the fourth PML patient from the trials died and that person heard the news while she was out shopping!) and I am being very careful to ensure that what I am posting comes from reliable sources, most of who were involved with fighting for this drug to be returned to market.

I'll let you know when I get anything further. The buzz on this is all OVER the net in the EU right now, but my French is high school level, my German is even worse, my other languages consist of "where's the bathroom" and "one beer please" and translating takes a LONG time even with available translators on the net!

Another thing to keep in mind is that as a whole, we know more than the hirelings manning the phones at Biogen patient support services. They are only allowed to say what the company and the FDA say they can say, which is why I suggest moving further up the food chain over there. I enjoyed enlightening my person while I was convincing her that I wasn't going to shut up or go away...

Yes, I noticed that all the people I spoke to today had audible sounds of exasperation when I informed them that I know hundreds of people taking Tysabri and that I was urging them all to call and complain about the lack of information available to us. I suppose that could interfere with the office Halloween party this week, eh?

They reminded me that they were giving me all the information they had and that they didn't know anything else. I insisted that they report and document my concerns and they assured me they would.

Excellent info, RW. Thanks, as there are other forums too that are scrambling to learn more.

Just a few points for clarification though ...

We knew that 4 since the reintroduction, and 2 - 3 of the original trial patients, were from the US ... out of the 13 (+ 3 trial) cases we knew about since the reintroduction. That would mean that 6 or 7 of the 16, or about 40% were from the US at that point.

Now we are aware of 24 (+3) = 27, which would be 11 new cases in the last month or so. Have you heard that the majority (and by how much) of the NEW cases are from the EU, or if just all up it is still leaning towards more EU patients?

You mentioned 2 - 3 from major centers in the US ... is that all that is rumored of the new cases to have occurred in the US, or was your point just that 2 - 3 of the cases are from major centers?

Also, since TOUCH is simply a monitoring process, you aren't suggesting that this system could serve to catch the PML before it happens, are you? It may not get as bad with an adequate monitoring program such as TOUCH, but I can't how see a program like that could effectively STOP any cases from occuring.

Thanks again for the summary, and I am really glad to hear the patients are fighting for their rights to understand their risk, just as they did when they wanted this product back on the market.

Cherie

http://www.forbes.com/2009/10/27/ms-...rtner=yahootix

Lots of detailed info from Ted Yednock from Elan.

Excerpt from the Forbes article

"The test Yednock and his colleagues developed found that something like 50% of the patients have JC virus. There are eight cases of patients who developed PML where Elan and Biogen-Idec have blood samples going back long before the infection happened. All of those cases had JC virus antibodies in their bloodstreams a year before they got PML. "That's a pretty good starting point," says Yednock.

Elan has transferred the assay to a commercial laboratory, a step toward making it available to patients. The test, which uses antibodies to detect the presence of JC virus, could be done with just a saliva sample. It has not been evaluated by regulators or the larger scientific community, but the hope is that doctors might be able to use it to pick which patients are the best candidates for Tysabri therapy."

Great Article.

What I can't understand is, that if they knew these people had the JV Virus antibodies running through their systems, why didn't they stop Tysabri before they got PML???

If I were you guys, I would get tested for the JV antibodies right away and if you test positive, get off of Tysabri immediately.

I can see why this revelation might hurt Biogen's bottom line and why they'd like to keep this hush hush....sheesh, what a bunch of greedy ********!!!!

I got a call from the Senior Director of Patient Services of Biogen Idec this afternoon and I have his direct phone number for future reference. He assured me that the risk is still within the 1:1000 even for patients with a greater number of infusions. The current number of confirmed PML cases is 23.

I explained to him why I disagree with the change in their reporting policy and why I don't think it's acceptable for them to put this duty on the backs of the physicians.

I thanked him for calling but until they change this policy or make it easier for patients to get accurate data and reports, I'll keep working for this to change.