we put up a cheerleading thread for you mary ann! we hope you do great! :hug:

Glad it went mostly well :)
What is the TYGRIS study ?
Linda

Mary ann, congrats on the first infusion and I'm glad it was so easy for you. I hope you have success with Tysabri!!:)

I'm getting infusion #16 right now. I have a lot of time to kill since they slowed the whole process down! Fortunately, they have internet access so I can waste some time! It took the nurse 3 sticks to get the line in. Ugh. And the first one hurt like hell. The last time it took 2 sticks. She is usually pretty good. Are my veins drying up or something?? :eek:

Natalie,

It could be the nurse's technique. My veins are fine if the person is skilled at starting an IV.

Natalie,
YAY!!! for #16!

When I had my appendix out, the surgeon told me to drink 3 liters of water every day because the surgical team had noted that I was dehydrated. I drink enough for me, I think, but when I told my infusion nurse what he said, she agreed with him.

I always felt that I had enough to drink because I wasn't thirsty, but after I tried drinking more, I noted that I WAS thirstier than I was before. I've increased my fluid intake since then and if I don't drink enough, the nurse always comments on my veins.

I got to thinking about it, and when I was more active I always had a water bottle with me and drank a LOT. As I became less active my fluid intake decreased and I just hadn't noticed. I stopped carrying a water bottle. Now I take a 2 liter bottle of water to work with me and try to sip on it all night. It does increase my bathroom trips, but I have gotten used to using the bathroom before I go anywhere now. I've noticed a change in the color of my urine, it's not as dark as it was before.

Drink more fluids and see if that helps, even if you think you drink enough.
Sometimes we just DON'T realize that we need more! :p

Natalie,
Glad for #16 :D Sorry for the sticks/pain :(
I agree with Riverwild drinking ALOT of water and noticing color of urine. My infusionists are getting better and smarter because I am. I have learned my veins are deep and rolling. I pass this along to whoever is doing it and I have many. I, also, let them use my hand (at times) it doesn't hurt much; the thought of it made me cringe but it's not bad.
Hope you have better luck with 17 :hug:
Linda

Yeah, I don't know what is up with the veins. It must be the nurse?? (Wiz you are probably right). At the old infusion clinic with the incompetent nurse I have to give him credit for only one thing -- I got 12 infusions there and he got the IV in on the first try every time!

RW: I did drink lots of water the past 2 times but I'm not sure how much of a difference it made. Maybe I need to drink the night before? I hear you on drinking lots of water. Several years ago I used to not drink that much water. I went out to lunch with a friend in Calif. and he noticed I drank no water at all and lectured me on staying hydrated in the heat!! Since then I make a conscious effort to drink a lot. Every infusion I bring a half liter bottle of water.

Polar: Sorry for the vein problems too.

Grammie: I wonder if my veins are rolling? I think this new infusion nurse said that about mine -- she also said the needle just didn't want to go into the vein.

Maryann: I've slowed the infusion down to 2 hours since I was having side effects from the Tysabri - headache, nausea, flu - like stuff.

Does anyone know anything about this? SEC is issuing a subpoena on Elan.

http://www.google.com/hostednews/ap/...0MeXgD9B15QB00

I went for my 31st infusion yesterday and got new RXs to hopefully get me kickstarted into some sort of action. Both are on hold pending Dr approval though, they don't consider the RX written by the Dr approval I guess... Nuvigil (I won't be on the old-vigil anymore if it works :p) also Topamax for the late afternoon headaches. I slept until 12:10 today and didn't really want to get up but my bladder made the decision for me.

The infusion nurse Susan at the Dr's office is hilarious. She's getting her NP license, going to school for it. I told her and the neuro I hope she stays at the neuro's office so she can be my PCP replacement. She was floating on air after I said that and I'm glad. She's so awesome. :) Although she has a bit of a temper and gets riled over somebody else in the office.

My neuro came in later and said if she goes to work somewhere else after she becomes an NP, and works for a doctor who is a "moron" she'll either kill him or quit after two days. :D And I can see that happening too, lol.

The neuro said that spring and fall, with the change of the seasons, are the most common time for flare ups. I didn't consider my overwhelming fatigue to be a flare up but I suppose it is. Of course I didn't call the office about it :o instead just waiting for my infusion day. That frustrates the neuro but if it were something really bad, he knows I would call. (Like vision problems or inability to walk or something.) He knows that I know the signs of PML too and the DH knows what to watch for.

I'll get the new RXs on Monday if they have them ready at our slow pharmacy. I had to go to the slow one because there was a coupon for the Nuvigil for $50 off. :eek:

#31 today!:yahoo:

As usual...no problems, no concerns, in and out the door.

I pumped up my water intake last night, and when the nurse started the infusion she commented on how nice my veins were today!

(of course, I had to use the bathroom twice during the three hours I was there but I have "nice veins"!! ) :p

Hope everyone is doing well!

I wanted Ty in 2006 but the 20% of $3,000 was too much for me.
Now I likely qualy for it and am considering it even more so after reading results here.
Copaxone was great for 3 yrs then numbness/atrophy crept in quick.
Went to Rebif for 4 months and now back on Copaxone. Zero sides from C.
I really want to try Estriol with C but Wyeth and fda need a spanking before that happens.
Glad to hear all the positive effects you's are having with Ty!

So how long do you stay on the TY once you start?
 

I am curious since I am about to embark on the ty journey. I was reading about the newly discovered PML cases and Biogen's proposal that people take drug vacations. But I also read about how most people bounce right back into full swing attack mode when they stop the ty so that would make no sense to me. But once your start the ty is there a long term plan... say we are going to keep you on this treatment for X amount of time and then what? Do you stay on this drug forever?

Biogen has not proposed people take drug vacation because MS disease activity does return soon after stopping.

Suggest we all contact MS Active Source on Monday and state that we will take no more infusions of Tysabri (Threat of stopping is probably enough) until they provide us with more info on the PML cases.

MS Active Source in the US is 1-800-456-2255. Let’s hit them with some serious patient driven pressure.

A jump in PML cases is concerning, but also remember that Biogen/Elan are testing various assays to diagnose PML earlier and risk stratify patients. It’s possible that these PML cases were identified (in this large clump) as a result of testing patients (those in Trials most likely) with these assays possibly before clinical symptoms.

Chris

I spoke to George at Biogen a few days ago and he said it takes about six months for disease activity to resume in what they've seen for people who have stopped Tysabri.

My MS neuro said that we could take a break from Tysabri if we wanted to but that there was no indication that it has any benefit to do so. He said that other neurologists around the country have been suggesting it and if we wanted to, we could, he was just letting us know (those of us in the infusion room).

Two of my infusion roomies have been on Tysabri since the beginning of the Antegren trials, so way longer than me.

I hope that answers your questions too Leggz. I get my 32nd infusion next Friday.

What clump of pml cases :confused: and where did you find this info ?
Linda

I haven't weighed in on the statement from the CHMP/EMEA yet because I have been away and then had to work a bunch of OT, but I have a LOT of information that I will post tomorrow morning when I have time!
(and as usual, I have a LOT to say...:p) :D

OK, sorry to be late! Work's been busy lately! :rolleyes:

The EMEA/CHMP issued a statement the other day that states that they are reviewing the risk/benefit ratio for Tysabri. http://www.eurobiotechnews.eu/servic...ash=58204a138f

The EU has no TOUCH program in place, and it is believed that they are reviewing the R/B ratio in advance of setting up a TOUCH-like program due to the number of PML cases. They stated the reported number of cases as 23.

As you will see when you click the link, the reporting news agency says the FDA has confirmed that there have been 23 cases of PML since 2006. Since BIIB/Elan both said in their quarterly conference calls last week that there were 15? cases, obviously what the FDA confirms makes it look like 8? more cases popped up in the space of a week? I'm sticking question marks in there because neither Biogen nor Elan confirmed that number yet, nor are they expected to, since they continuously state that they will not release the number of cases of PML anymore.

This is unacceptable to me as a Tysabri consumer. I've already let Biogen know that when they called me this week to tout their new patient support program. I am asking you to do what I and many others are doing. Please don't just blow them off if and when they call you about this support program. Please speak with the person who picks up the phone when they redirect your call.

Ask them if there is any way to ENSURE that your conversation is being taped. Tell them you want to be heard. Let them know how you are doing on Tysabri and then tell them you aren't happy about them keeping patients in the dark about the PML patients. Let them know you understand about privacy but that we are not asking them to give us names. Tell them you want the country, the age, the sex, the previous treatment history and what drugs they were on, how long they were on them, how long after prior treatment did they start on Tysabri and how long they have been on Tysabri. Tell them you want a call back from a superior in the company with some answers.

Tell them how you are unable to comfortably assess the risk when you have no information. Tell them it's too long to wait for your next scheduled visit with your neuro. Tell them you are very uncomfortable with continuing to use Tysabri because of the lack of information. Just keep talking until they get someone else to call you back. Let them know we are talking, comparing notes and moving toward action as a group worldwide. Tell them how you believe that having to search investment news is the wrong way to get information. Tell them you are NOT a mushroom and you don't like being kept in the dark and being fed ****. Remind them that they are making a LOT of money off US and that we as patients deserve to be kept up to date more than anyone else does, since we are the people who are at risk!!

Try to do all this while maintaining a polite tone. It may be hard to do but give it a shot. Just be firm and continue to state that you want someone to call you. Take the name of the person you speak to and ask them to be assigned as your caseworker so that you can follow up if you do not get a call back from someone.

We as a group can have an effect here. We deserve more information and we can make sure that we get it sooner rather than later. When Tysabri was withdrawn from market back in 2005, it was the patients who made a difference and we can do it again if we all work together.

On a more sorrowful note, the first man who was diagnosed with PML after Tysabri's return to market has died. His wife posted to a German MS site that is keeping track of PML cases along with people here in the US. I am not going to copy and paste it here since it is long and needs translating which makes it longer still. It's just sad and my sympathies go out to her and the rest of his family.

As usual, I'll post whatever I hear and hope you all will do the same. I hope everyone's doing well! :grouphug:

I just got off the phone with a Biogen support rep and told them about my concerns. I told her that I'm thinking of stopping taking Tysabri since the reports about PML aren't being made public anymore. She got nervous and started to read from a report stating the the company's new policy about regarding the reporting (or lack of) new PML cases.

I told her I was calling my doctor to ask him more about this. That really isn't fair that they should have to handle this though. My doctor's office isn't making any money off of doing the infusions. They don't charge much for the infusions and it costs them more than they make from all that's involved. Why should they have to do Biogen's dirty work?

RW. Great ideas. I'm getting ready to call Biogen now. Which patient died? There were 2 announced at the same time. Was it the treatment naive man who was on Ty. for 17 months or the 56 year old guythat was much worse off?

Found the post over the weekend. Called Active Source this morning. Didn't like the person I spoke to- Tanya - Asked to have my case manager call me.
I had #39 last Fri. Thank G-d doing well :D

Wow. Biogen entry level phone staffers seem clueless. She said she wasn't aware of the increase in PML cases and started to rattle off the 1:1000 risk info. She just kept apologizing. Her name was Kristen.

I will give her credit for passing me on. I'm on hold right now to speak to a "higher up" person.

Ohhh, she came back and claimed that no one else knows any more information than she does. I think it was a fake play. No one wants to deal with this at Biogen. How frustrating. She told me to call my doctor.

By the way I was told all calls are recorded but I think it is good to ask. At least all my complaints are on record if they even bother to review them or pay attention.

Call back and ask for a supervisor. Tell them to make sure your concerns are reported to management. Try to get a number in corporate to call.

Yes, I asked that my concerns be reported to management. The "higher up" was the supervisor who she said didn't know anything more.

I went to the Biogen Idec website and clicked on management, then found the "contact us" phone numbers. I called and asked for one of the management team and spoke to their assistant. Somebody is supposed to call me back.

Sending you a PM for that email address Natalie.

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...:D

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? :rolleyes:

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. :confused:

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

Great Forbes article with details on the status of the JC Virus Assay
 

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??? :mad:

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 ********!!!!:mad:

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.