Maryann, congrats on #4!! I'm glad you are feeling better and noticing a difference.

RW, congrats on #34! Whoohoo!

My Tysabri has been delayed for yet another stubborn UTI. It's been 5 weeks already since the last infusion... I have to wait another week after changing antibiotics. The nurse suggested that I might have to switch to getting my infusion every other month because of these UTI's. She said that they have several people who started getting infections on the drug after awhile and they switched to every other month and all was fine.

I'm a little apprehensive about this. On the one hand, will it make me less apt to get PML? Or have no effect on the PML risk? On the other hand, if I'm only getting it every other month will it still work on keeping the MS at bay? Ugh...Everything with this drug is still trial and error according to the docs.

Regardless, I can say that I am sick of the UTI's. I've gotten 4 in the last 4 months. :( Prior to that, I had not had one in more than a year at least--actually I got one after infusion #2.

Natalie, I feel for you! After having my very first UTI, I know I don't want anymore!

I'm taking cranberry caps now along with all the other various medicaments. Hopefully they will help to stave off another one for me. I'm doing 6 a day because I hate cranberry juice, so I'm eating cranny instead.

The only thing I can tell you about the timing is what the studies show and they show that for your immune system to get back to normal and for all the Tysabri to be out of your system takes 2-3 months, so you should have some protection if you are doing infusions every 2 months, but if there is any breakthrough disease activity, every four weeks is still the recommended dose.

Hope the UTI goes away and that you get back to your "normal" soon!

Hey RW, yes I am taking the cranny capsules too! My urologist said they work better than the sugar free juice anyhow.

I think another option may be to take a half dose of Tysabri once a month. I have never had a second relapse so I guess I fear that if I take less Tysabri that may become a reality. I'm trying not to worry too much. Maybe my body wants a small break.

I think whatever relieves your stress is a good course!

It was my decision to skip the infusion after my surgery for the ruptured appendix, not the doctor's. I didn't want to add it on top of the antibiotic cocktail they were pouring into me, and I figured the stress of surgery was enough for one month. I am not afraid of skipping an infusion if I feel it's best for me, and part of our health is our stress level!

Hope things get better soon!

Natalie, sorry you are going thru this. Hope the UTI clears up soon!
Linda

Well it's somewhat official, at least for now--I'm going to every other month Tysabri. I talked to the research nurse at my MS clinic today. She deals with the clinical trials that the med. school sets up, including an original Tysabri trial she participated in. I got some useful info. And she gave me her direct line phone number which is cool since not everyone gets it!

According to the nurse they have at least 10 patients (maybe more) they have put on Ty. every other month because of chronic UTI's, vaginal infections, or respiratory infections. In addition, there is one patient who lives in Costa Rica, and a few others who can only make it to the clinic every other month and get their Ty. that way too. She said that none of them have had breakthrough disease activity with the MS on the every other month plan. But there are still many unknowns. She said Biogen had to "choose" an amount and regular schedule for Tysabri (300 mg. every month) but why they chose what they did is not completely known. My med. school is working on creating some clinical trials to do alternative dosing with Tysabri (what happens if you give it every other month, what happens if you give a half a dose every month etc. etc.). There is a PhD researcher at the school who is studying Tysabri and PML as well and they meet every week to discuss the drug and PML.

She also told me that my clinic has been sending blood samples of new Tysabri patients to the NIH for the past year and a half. The NIH is testing the blood to see if there are immunologic changes along the way that might give them some idea as to who is at risk for PML. They are also looking for information on how to create a vaccine for JC virus. When she mentioned the possibility of a vaccine she described it as 5-10 years down the road. Doesn't sound promising for something right away. Other testing sites have been sending the NIH blood too. The NIH won't tell the clinics the details except that the NIH said they have found some surprising and interesting stuff that is useful for studying the JC virus. I guess the NIH is being tight-lipped about it all--I'm only guessing but I imagine that researchers feel very protective of what they find for publication reasons among other things.

I asked about the assay that would test for JC virus antibodies that we've heard about from Biogen--the business newspapers/magazines have been saying it would come out in the first or second quarter of 2010. She didn't have much to say about that except that Biogen is very protective of what they have discovered because they want to come out with and market the test before anyone else. It made me realize that the information that Biogen slips to the investors (hey, we have this antibody test that is coming out in 3 months!) may not always be accurate--they are trying to insure their stock prices stay high so why wouldn't they be overly optimistic about everything? It's all about the $$$. The problem is they give info to the investors that is probably more on the rosy side and they give even less to the patients!! But now that I have this nurse's phone # I feel like I have a resource I can call if I want the most up to date info on the drug. Even my own neuro has talked badly about the drug companies! And wow, I just remembered that the doctor I saw at the Mayo Clinic really trashed the drug companies b/c the Mayo Clinic takes no money from pharmaceutical companies--it's against their style of practicing medicine for the sake of medicine, nothing else.

Natalie, I'm so sorry you're having such a difficult time with the UTI.

I go for # 29 tomorrow. I saw my neuro on Wednesday and we have decided that after this infusion I will be going every 6 weeks rather than every 4 weeks. This time I actually waited 5 weeks because of New Year's and I didn't have any problems with it....so, I'm hoping that every 6 weeks will work out well for me.

Every neuro I've spoken to has suggested 6 weeks between infusions after the 24 month period. But, Natalie, I'll be very interested to hear if 8 weeks works for you!!!!!!!!!!!!!!!!!!!!!!!! So far no one has mentioned taking 1/2 a dose :( I'll have to ask about that tomorrow. Perhaps my infusion nurse will know something about that. It would be another alternative. I'm trying to decrease my chances of PML by having less infusions. I don't know if that will work or not but until they have developed the assay to determine who is more likely to get PML I can't think of anything else to do. For me stopping the infusions is NOT an option. I'm doing so much better on Ty that I can't believe the difference it has made in my life :)

On another note...my husband is slightly upset with me because I forgot to mention that there are now 28 cases of PML. I heard about them while we were in California last month and I was so busy with the grandchildren that it slipped my mind. I'm trying very hard not to dwell on PML and other negative things. I really think that staying as positive as I can and trying not to get stressed every time I hear the words PML is in my best interest.

It's sad that we have to get most of our info from articles pertaining to Biogen's stock :( But, for them the bottom line is money even though they claim that they are interested in what is best for the patients.

No PML update for month ended Dec 31, 2009 yet. Biogen CEO alluded that the update will be posted sometime next week.

Chris

Hi Shayna,

That is very interesting that your neurologists are suggesting moving to every 6 weeks. That sounds like a good compromise instead of going completely off. I hope the 8 weeks works for me. Mostly I just hope it stops the UTI's because I have been getting fevers with the infections which really make me feel crappy. I will keep you posted! I've had to have shots of rocephin to knock the UTI's out plus oral antibiotics. I've only had #18 infusions so far. I love my Ty. But like you, though, I try not to worry about the PML. Lately I have been better about not stressing so much about it. I try not to read too much PML stuff and only come to this board to be updated on Tysabri.

Good luck Shayna with your 6 weeks!

I heard 4 more cases were noted Wed.

I've lost track of whether they are cases we already know about and they are confirming or whether they are new cases not on our charts, cause it's getting tiring trying to find more info and get a straight answer out of the !@#$%^&*.

Just media confusion as they never had the 28 case number. Biogen CEO said the case count was 28 as of mid Dec. Analyst asked about the potential for a 29th case and he said it was certainly possible but that the official update would be available sometime mid next week (13th or so).

That would explain why my count is 33 with three unconfirmed cases.

I just found this article on a recent conference call between Biogen's CEO and Goldman Sachs regarding Tysabri, among other drugs. It really gives you insight into the mindset of those in charge at Biogen and in particular the need to make $$$$. The CEO is retiring. Sounds like he doesn't want to have to deal with the PML issue anymore although the company claims it will be more transparent and consistent in terms of how it disseminates info on PML cases.

http://www.xconomy.com/boston/2010/0...departing-ceo/

There is nothing wrong with a drug company wanting to make money. That's what they are in business for and Biogen/IDEC is no exception.

But it's how these companies conduct themselves in doing this. If you look at how Biogen has handled the entire Tysabri situation, it isn't hard to see that profit making has been made at the expense of MS patients.

When trying to make a decision as whether to use Tysabri or not, this just adds one more wrinkle as to whether MS patients are being told everything there is to know about this powerful drug.

Harry

This is very scary. Thanks for the link Natalie. Unfortunately very informative.

You know, I realize my chances of getting hit by a bus are greater than my chances of getting PML but for some reason, I feel safer with the bus!

This may be a stupid question but I am not seeing a breakdown anywhere... How many people treated with Ty for Crohn's disease have been diagnosed with PML? Is it just the MS patients?

To my knowledge, only 1 patient (1 of the 3 clinical trials patients) with Crohn's (taking Tysabri) has been diagnosed with PML. My guess is that this is because many fewer patients are taking Tysabri for Crohn's and the time exposure has been less because this indication was approved much later/harder to set up commercially (needed Neurologist's to act as consults).

Natalie,

I listened to Mullen's presentation at Goldman Sachs (available over the internet at BiogenIdec's web site). I view his comments on his departure as reflecting stability/increased confidence in the Tysabri PML issue (or why wouldn't he have left when PML was discovered in the Clinical Trials).

Chris

Biogen and Elan presented at investor conferences this week.

JC Virus Antibody assay to be available in months - 11 out of 11 PML patients who had blood samples prior to PML diagnosis tested positive on the assay

Discussed launching a trial comparing Tysabri to Copaxone and Rebif

Discussed expanding the indication to Secondary Progressive MS

Research continues on link of duration of therapy, prior immunosuppressant use, viral factors and patient factors to PML risk.

Just an FYI as to cost of Tysabri.

As of 12/17/09, the price of Tysabri that doctor's offices pay will increase slightly to $2399/vial (13 infusions/year will cost 31200). This is about a 2% increase over last year.

I'm going to get a copy of the bill my insurance receives and compare it to see what the infusion center is getting now! Last time I checked the ins. co. was paying $7500.00 a month for the whole process, med, infusion, supplies, chair, etc. I noted the vial of Tysabri was paid at $6500.00 and the rest was covered at 1000.00.

The infusion center was BILLING 7500.00 a month for the Tysabri alone and another $2500.00 for the infusion stuff, for a total of 10K +.

The last time I checked a billing was back in 2008, since my insurance company covers it all under hospital coverage. It will be interesting to see how much they are charging now!

WOW that is outrageous! I check mine every month... (keep a running tally as to how much the insurance pays out).... Ty infusions are around $5800 total costs. Which is cheaper than the 6400 they paid each time I needed IVSM. In total last year my ins co paid out more than $64,900.00. Of that, over $40,000 was for MS treatments, check ups, and MRIs. Unfortunately once my Cobra runs out, I am up a creek without a paddle. Last time I looked into purchasing a policy it was over $700 a month, I am sure it is going to be higher now.

Cost Effectiveness and budget impact of Tysabri for formulary inclusion...

http://www.ncbi.nlm.nih.gov/pubmed/2...m&ordinalpos=6

Wow. :eek: I'm just shocked at those prices! I know we have had this conversation before. What stuns and upsets me is the incredible variation in terms of how the drug is dispensed and infused and what people must ultimately pay out of pocket. I buy my Tysabri through my Rx plan so my insurance plan pays out the $2399. Then I have to pay my Rx co-pay which is reasonable since is is not through "medical." Then the specialty pharmacy ships my Tysabri vial to the doctor's office. Then my doctor bills my insurance for $498 to infuse the thing. I pay my doctor visit co-pay to have them infuse. I feel lucky.

Those infusion clinics are making a killing. There is just something so wrong with that.

Well now I'm going every other month so it will be even cheaper. I just remembered I have to make sure my specialty pharmacy doesn't keep sending it once a month or I will end up with extra vials.

...and I feel lucky too! I pay my insurance premium, show up at my local 25 bed hospital for infusion once a month, see the doc every three months and revel in no relapses, no copay for the whole cost since it's covered under major medical (and NO injections), despite what I see as a high cost for the insurance company ~BUT~ I know there are people who use the same place who have no insurance and cannot afford to pay and they still get their infusion, and I know I am supporting them and I don't mind that. I think everyone who is ill or has a disease deserves effective treatment, regardless of their ability to pay...but that gets us into the debate for health care as a right, not a privilege...:D

I really hope that is the case RW! I don't mind supporting either. I am just thinking of Victor H. who had to stop Tysabri because he just couldn't afford it anymore--part of the problem I think was the excessive cost of the infusion clinics in his area. :(

31 PML cases as of Jan 12, 2010. No significant changes in the incidence rate after 24 infusions.

Would you share where you got the info ?

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

They've updated the chart.

A little more data

"So far, 19 cases have been detected in Europe, 10 cases in the United States. Two other cases have been detected elsewhere, according to Biogen officials. "

Also 8 of the 31 PML Patients have died.

The infusion center I go to has 10 recliners for the patients receiving chemo or Ty. I don't know if they infusion anything else......they refer to it as "the chemo room". The drs are oncologist. My Ty infusions cost between $5500 and $6000 per infusion depending on whether or not they draw blood and I talk to the dr. I'm lucky that I only have to pay the $25 co-pay for a visit to a specialist. But, my monthly medical insurance is $900 :( It's hurting us financially but I refuse to give up my medical insurance. They can't kick me out because this is covered under my husband's plan and he is "grandfathered" into their insurance policy :) If I give this up I'm not sure that any other insurance will take me. Ty is expensive!!!!!!!!!!

When I went for my last infusion there was a Ty patient there that I had not seen in a very long time. She told me that she couldn't afford her medical insurance last year so she had to go without the infusions. She's back in a wheelchair now :( She's really hoping that once she's had several infusions she'll be able to walk again. Prior to having to stop the infusions she had been on Ty for 2 years.

My next infusion is scheduled for February 19 because I'm trying to wait 6 weeks between infusions. I'm hoping it will decrease my chances of getting PML. The fact that there are now 31 confirmed cases does not give me a warm fuzzy feeling. I hope they have that assay available soon!!!!!!!!!!!!!!!!!!!!!! But, if I test positive I'm going to hate giving up my Ty.....LOL

I hear you! 31 cases is a lot to handle mentally, especially since we only had 13 supposedly in September. I am also anxiously awaiting the assay test.

I go for #19 on Monday after 8 weeks break. I'm taking prophylactic antibiotics (Cipro) around the time of the infusion. Cross your fingers that I don't get UTI #5. The only thing I have noticed after 8 weeks is the vision in my left eye is only slightly less sharp (that was the optic neuritis eye) and maybe the balance is a little bit more off but other than that everything seems fine. My energy level has not gotten any worse. I will tell you that my depression has gotten WAY better which makes me wonder if the Tysabri has been causing depression as a side effect.

Still, I am sooooooo glad I went on this drug.

Biogen and reporting on Tysabri numbers-
NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) will communicate with doctors once a month on the occurrence of new cases of a rare brain infection in patients using its multiple sclerosis treatment Tysabri, as the biotech strives to find the right balance in keeping the medical and financial communities updated on that important number...

I think we played a part in educating Biogen on this one! The article I have is for subscribers only. Drop me a PM for the full article.

There's also this thread:

http://neurotalk.psychcentral.com/thread106605.html

I had infusion #19 today (after an 8 week break). The slowed down infusion (2 hours instead of 1) is still the way to go for me. I am having relatively few side effects from my infusion which is nice. My eyesight went back to being really crystal clear sharp again!! Strange, huh? It had started to blur up a little over the 8 week break. Anyhow, if I don't get a UTI this time we may go to 6 weeks in between infusions. I'm not sure I want to go back to every 4 weeks for fear of PML and UTI's. It's all still play it by ear.....

That's great news about your vision, Natalie! It's nice that they're willing to be flexible about giving you breaks from the infusions as needed.

-----
There is an article in Motley Fool telling how to get PML updates:

http://www.fool.com/investing/high-g...do-is-ask.aspx

It seems that ordinary people (non-MDs) will have to ask for the PML updates every month from Biogen's investor relations department.

Glad to hear it went well, Natalie! :hug:
I noted some lessening of muscle control of my eye when I had the break due to appendectomy last year, along with blurring. It just proved to me yet again that Tysabri actually has a beneficial effect on symptoms for me!

Thursday is #35 for me.

Good luck with #35 RW!! Very interesting that you also noticed eye issues with your Tysabri break. My neuro told me Ty. was particularly helpful for cognitive, eye, fatigue problems which is why she recommended it. I hate to mess with the vision which is why I go back and forth about what to do as I near the #24 mark.

Actually, I had a delay in Ty. side effects from the infusion. Later last night I felt very achy, nauseous and spaced out to the point of messing up words. But I've had this happen before and know it goes a way in a couple of days.

Natalie, sorry to hear you were feeling rather lousy after infusion :( I am so fortunate that I do so well with my infusions. Tomorrow will be 42 for me :p

RW, hope all went well today :)

Anyone see their neuro... get any Ty/pml info?

Linda

# 35 down and done with the usual no problems and no concerns. :)

The only new info I have until I see the doc next month for the news from the KOL Conference is from Pit. His chart notes 33 PML cases with the last two unconfirmed as of yet, which is the same number I have. I'll post when Biogen opens their sticky fingers tomorrow and confirms the last two via their investor relations department. The bad part of the new cases is that they all are up there on their doses, ranging from 37 to 52 doses. The US leads now with 11 cases, one more than Germany.

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

OTOH, Tysabri has now reached what the pharma business refers to as "blockbuster" status, with a billion dollars in sales in 2009.

I for one look forward to the assay and a vaccine in the future, cause after 5+ years I am growing weary of working to separate truth from rumor. Biogen's open and honest communication truly needs more work, regardless of the steps they have taken to appease us in the past few months. :mad:

Hey Natalie?

The vision problems I reported could also have been due to all the meds I was on after surgery and during recovery, I forgot about that.

I was looped and was happy to stop them, even though I was in love with that measured dose pump full of Demerol! :D
It was much easier when I was younger for some reason! I'm a lightweight now and even Tylenol 3 and Vicodin hit me hard. :p