Originally Posted by yeahbut (Post 405358)

... What I was most impressed with and didn't realize is that "gray matter" that is very hard to detect is now a consideration of a dx. I haven't had time to go and research it more but hope to do it today.

This doctor is one to start treatment early. Feels that early treatment is very important. I was very impressed with the whole session. Learning more about Tysabri was good for I have never really investigated it...

I also would encourage people to attend if you are questioning treatment. I am going to another seminar on the 19th sponsored by Bayer.

What I was disappointed with and expressed to the reps was that we only heard the Con's of the drugs. Nothing about the possitive effects it has and how it has helped the ones who are still on it. I was told that it is not legal for them to do that. How sad! Yes, it is good to hear the con's but I am just as interested if not more in the possitive's of the drugs. They expressed they wish they could but they are stuck for legal reasons. Now that I would LOVE to be on a panel to change!

Originally Posted by Riverwild (Post 404875)

As I posted on the MS forum, Yabbit and I attended a seminar sponsored by Biogen/ MSActiveSource. This is going to be a long post!

I was specifically interested in the Tysabri questions people asked. I also got to speak to the two Biogen reps about my concerns and get some answers to some questions.

I took some rough notes on questions and this is what I got:

They admitted that the monotherapy rate of PML is 2:35K+ at this point.

There is some thought that Pt. #1 back in September may not have had PML at all!! He was the one who had no JCV showing in his CSF after first LP and an extremely low level after LP # 2. His MRI was reviewed by a number of neurologists and radiologists and most of them feel that it wasn't PML. This was the patient who was treatment naive and is recovering at home. He had some IRIS problems after treatment with PLEX and mefloquine and more info. would be forthcoming as it is known.

Pt.#2 definitely had PML. He was the one whose neuro continued Tysabri and administered steroids before finally testing for PML and he is still in a rehab, with major disability. He was just brought out of a drug induced coma last month. He is suffering from IRIS and they are not sure what will happen with his case. This is the patient who had been on Imuran for years, along with CRABs. It is not known when he had his last dose of Imuran.

Pt#3 ( US patient) is recovering at home. There is still no information at this time due to HIPAA laws. This patient was 14 infusions, had methotrexate prior to Tysabri and had her last dose of metho 4 months prior to first Ty infusion.

I asked about Ty as first line therapy. Answer was every person with MS is different and what would be prescribed for one may not be done for another. If a pt. presented with a lesion load of 20 and 2 severe relapses within a short span of time, doc would be more likely to prescribe Tysabri, than for one with severe relapse and only two lesions. It depends on case and amount of risk patient and doc were willing to assume, but that Ty IS being prescribed for first line.

I asked why Ty is not prescribed BEFORE Novantrone, Imuran, Methotrexate, Cellcept, etc. They said it will come as neuros become more comfortable with Tysabri. It was also stated that Ty will be prescribed more for first line therapy as neuros become more comfortable with it.

For both of the above questions, the example was given: Remember the early 90s when there was a lottery for Betaseron? Some people couldn't wait to get on it and some crapped all over it for whatever reason. As it became more accepted, more people were treated. As each new drug came out, the same thing happened. There's no one perfect choice. Every patient is different and every doc is different and every treatment will be different!

I asked about washout times for patients who are on heavy duty treatments. Doc responded that he would not be prescribing for anyone who has been on those treatments until more info was available. He felt that some of them ( Novantrone was used as example) stay with the patient for a year or more and that more information is needed.

The cost of Tysabri is now 2295.16 per dose. Previous price was 2228.31

Biogen and Elan can help with the cost of the drug, but NOT with infusion center costs. I stressed the need for more information to be available for people who call and ask about this. I asked them if a system could be set up to direct people to places where they COULD get help with costs, such as NORD, and other organizations. The rep stated that they are not allowed to help with actual infusion costs as it could be construed as "enticement" to go on the drug, but agreed that something could be done to direct people.

I spoke to the reps about MSAS specifically. I have NEVER heard from my case worker since I got the first call to welcome me and the second call with my appointment information and insurance information. I admitted that I may have scared the girl when she called to "welcome me" as I had waited three weeks for that call and she had nothing for me except the "welcome". I told them that when you are on Copaxone, the SS people are right up your butt with info, mailings, calls, etc. Not sure if that happens with the other CRABs but it sure doesn't happen with MSAS.

I spoke with her about the MSAS site and how Tysabri was NOT EVER mentioned by name ie: "Biogen- Makers of Avonex and another MS therapy" and that the Tysabri.com site directs you to call the number and you get an Avonex rep and that it is VERY confusing for some folks! I told her I would have brought in my laptop to pull up the sites but that both of them were down when I went to them to get a screen shot to bring up earlier while I was waiting for the seminar to start! Their reply was that they are required to clear everything before it is put on either site, every word of the advertising and packaging for the free stuff they passout has to be approved, every word they say through MSAS has to be cleared, etc etc etc. They admitted that they are as frustrated as many out here are, and that it is getting better slowly, and a lot more activity has been seen since another drug company has come up with a generic for Avonex ( now tied up in court) I had more to say about all that but since it's more about protecting a cash cow I will hold it back from this thread...:cool:

I also brought up the problem some people have had when signing up for these seminars and they ask you what treatment you are on and there's no check off for Tysabri. It's not like that on every seminar listed but it is like that for a few of them!

A lot of the attendees asked Ty questions. It was good to hear some of the misunderstandings about Tysabri and hear them officially corrected!

Good seminar. If you get the invite, take advantage of it and go!

Originally Posted by lady_express_44 (Post 405953)

Since we have to go to the Tysabri thread to read your notes . . . and then refer to this convo (about your notes) HERE . . . I'll cross reference the two threads:



As far as the ratio of PML cases they are "admitting" too, I'm not sure how they can make such a claim.

A very large % of that 35,000 have not been on Tysabri for 18+ months, but the "acceptable" PML ratio was determined on the basis that those “who received a mean of approximately 18 monthly doses of Tysabri" . . . "it was estimated that the incidence of PML was 1 case per 1000 patients over 18 months”.

http://www.pubmedcentral.nih.gov/art...medid=18360634

At that point they were suspicious/hopeful that the PML cases occurred only because of combined therapy, but unfortunately we know that those same people in the trials may have gotten it from Tysabri alone now ...

Last I heard, there were about 9,500 people (which isn't a mean, but the only # we have to work with) who are (or have been) on Tysabri for 18+ months. That is a cumulative number, which includes all the people that were on Tysabri in the trials, plus since the trials.

From what we've been told publically to date, there were 3 cases of PML in the trials, 2 in Europe, and now one in the US. Hence, the ratio should be now be closer to 6:9500 (or 1:1583).

They can't add in the people who've been on just a few doses to determine the current ratio 2:35,000 . . . when the original "estimation" of acceptable PML cases was based on an average of 18 doses. :confused:

They also can't include the number of people in the trials who were on 18+ months (giving a total of 9500). . . but then drop counting the three PML cases from the trials because a few weren't on monotherapy when they got it.

Cherie

Originally Posted by lady_express_44 (Post 405953)

Last I heard, there were about 9,500 people (which isn't a mean, but the only # we have to work with) who are (or have been) on Tysabri for 18+ months.

Originally Posted by Av8rgirl (Post 406490)

Do you have credible source for the information I bolded above, Cherie? The 9500 people on tysabri for 18+ months? I've not found any credible source for that statistic and neither has my Biogen Rep.

Thanks! :)

Originally Posted by lady_express_44 (Post 405953)

As far as the ratio of PML cases they are "admitting" too, I'm not sure how they can make such a claim.

A very large % of that 35,000 have not been on Tysabri for 18+ months, but the "acceptable" PML ratio was determined on the basis that those “who received a mean of approximately 18 monthly doses of Tysabri" . . . "it was estimated that the incidence of PML was 1 case per 1000 patients over 18 months”.

http://www.pubmedcentral.nih.gov/art...medid=18360634

At that point they were suspicious/hopeful that the PML cases occurred only because of combined therapy, but unfortunately we know that those same people in the trials may have gotten it from Tysabri alone now ...

Last I heard, there were about 9,500 people (which isn't a mean, but the only # we have to work with) who are (or have been) on Tysabri for 18+ months. That is a cumulative number, which includes all the people that were on Tysabri in the trials, plus since the trials.

From what we've been told publically to date, there were 3 cases of PML in the trials, 2 in Europe, and now one in the US. Hence, the ratio should be now be closer to 6:9500 (or 1:1583).

They can't add in the people who've been on just a few doses to determine the current ratio 2:35,000 . . . when the original "estimation" of acceptable PML cases was based on an average of 18 doses. :confused:

They also can't include the number of people in the trials who were on 18+ months (giving a total of 9500). . . but then drop counting the three PML cases from the trials because a few weren't on monotherapy when they got it.

Cherie

Originally Posted by Riverwild (Post 406579)

Scroll down to "Revenue Performance" and it says as of September 30, 2008 there are 35,500 patients worldwide. In the US there are more than 19,500 patients on Tysabri commercially. There are more than 15,300 patients rest of world on Tysabri commercially. In global clinical trials there are more than 700 patients. Cumulatively in the combined clinical trials and post marketing settings there are more than 48,000 patients who have been treated with Tysabri, of those patients 18,000 have been treated for at least one year and 9500 have been treated for more than 18 months.

That was September 30th. The run rate at this point for Tysabri is around 325 per week worldwide signing up. That is straight from the rep's mouth. That would make it a conservative estimate now of 37,500+ patients commercial use worldwide.

Of those patients only one can truly be considered monotherapy. We were not talking exact stats. I was reporting on a seminar and what was said there. That is where that figure comes from.

Of the 3 people who were diagnosed with PML prior to Tysabri being withdrawn, we have debated that to death. One was a Crohn's patient who died from what was diagnosed with astrocytoma. They dug that patient up and changed the diagnosis to PML. The patient was on immunosuppressants. The second patient was also in a combo trial with avonex and Tysabri. That patient is alive. The third patient, Anita Smith-combo trial with avonex and tysabri- was misdiagnosed with MS and died from PML.

Monotherapy...ONE patient, with a questionable diagnosis of PML at this point.

Deaths from PML...TWO, one with Crohn's and a history of immunosuppressants, one in a combo therapy trial who was misdiagnosed with MS, both from before withdrawal.

I am not sure what you want here Cherie. Do you want to argue what was said at a seminar in a conversation? I had a witness to what was said. Do you just want facts and figures? Go hunt them down. I have a full time job, along with many other things going on in my life. I've got thousands of pages of studies and information on Tysabri. I don't have time to go through every page to debate with you over stats.

I've been involved with this drug for many years. I have done my homework. The fact remains that hundreds of people are benefitting
from it. I am sure we will hear more about PML and I am sure a lot of people will decide not to take Tysabri and that is their choice.

Originally Posted by yeahbut (Post 406661)

I am that witness, Cherie what she said did come right from the rep's mouth!

Originally Posted by Riverwild (Post 405885)

I am back to edit my previous post for a typo that I made.. I am not going to change the previous post, but make the change here so there is no question that the rest of the information stands as posted.

"They admitted that the monotherapy rate of PML is 2:35K+ at this point."

That statement should read 1:35K+

One patient, naive to ANY treatment outside of steroids, no interferons, no copaxone, no immunosuppressants, nothing. That is the ONLY patient who was truly a monotherapy patient out of every patient who has been diagnosed with PML and that is also the patient whose diagnosis is in question at this time.

Originally Posted by lady_express_44 (Post 407062)

Perhaps the Biogen rep said 2:35K, or perhaps he said 1:35K . . . but since I was not there, I will not attempt to debate what was said or interpreted from that Biogen sponsored seminar.

Before we try to get into the “hearsay” that is out there though, let’s see if we agree (or if disagree) on the published “facts” to date, as I know them:

1. SIX people have been identified as having gotten PML while on Tysabri; two in the MS trial, one in the Crohn’s trial, two from Europe, and one from the USA.

2. The acceptable ratio of PML (from when it was brought back on the market) was determined on the basis that 3 people in the trials, of the approx 3000 people that participated, came down with PML; 3:3000 (or 1:1000).

3. The “mean” length of treatment, whereby PML surfaced in the trials, was determined to approx an 18 month period.

4. There were a cumulative 6600 people (including those in the trials) who have/had been on Tysabri for 18+ as of Aug/08.

5. The latest number cumulative (including those in the trials), that has been published for those who’ve been on Tysabri 18+ months, is 9500 patients.

I have links to all of the above statements, but if anyone has contrary written evidence, please provide it.

Once we determine where there are misconceptions on those points (above), we can rectify our perceptions and then can go forward with any further debate on "hearsay" and number crunching from there. P

Cherie

Originally Posted by Av8rgirl (Post 407108)

Thanks Cherie. Once again you have all the facts!

Originally Posted by 4boysmom (Post 409029)

My guess, from reading through this thread Cherie, is why bring up any remarks at all if you are not on the med, and are only trying to be negative?

I'm only reading this thread because I'm on Ty, and I want to hear what others say about it. I don't want to hear a negative slant from someone that has never even been on the drug. Stay off the Ty threads unless you have a stake in it! I never contribute to Copaxone threads because I have no experience with it.

If someone has been on it, and wants to say something negative about it, that is great! In fact, I question often if my being on Ty is the correct thing!

But you know what I've learned from this thread? I'm grateful my neuro went from Avonex to Rebif, and then to Ty so that I'm on it now without ever having one of the other "harder core" meds that could possibly contribute to PML. It will remain to be seen.

You see, I'm a 47 year old woman who only has some balance issues and a tingly left hand, works full-time and in most ways doesn't suffer from anything serious because of my MS. And that is how I want to stay, and that is why I'm on Ty! I don't want to get worse. I want to be in great shape 20 or 30 years from now.

Avonex wasn't strong enough (more lesions after a year), Rebif made me tired and somewhat itchy, but it wasn't horrible, nothing in my bloodwork anyway. So I could have stayed on, but instead switched to Ty because I felt it was the best med out there for keeping me as I am today. Only time will tell if that decision was correct. I have faith that it is!

Originally Posted by SandyC (Post 409174)

And this thread is proof why I don't even bother to read about stats. Jim and I prefer personal experience to stats. Just because stats say one thing doesn't make it true for everyone. And why is it so important to be right? Just let the motion of the ocean take you away and let the storm brew somewhere else.

This thread is a simple personal experience, not a debate or who can find the stats contest. Those of us who have never tried this med would appreciate a simple conversation about the med and not a debate on who's right and who's wrong. I am more apt to listen to those with personal experience instead of what is written in some stat book.

JMHO

Originally Posted by lady_express_44 (Post 409183)

I agree whole-heartedly with that Sandy, which is probably apparent by the methods I've chosen to treat this MonSter. Scientific "proof" and "stats" can obviously be misrepresented and misconstrued, so I don't give them a whole lot of merit either. :rolleyes:

However, if an inaccurate "FACT" is posted, which might have the effect of influencing others, I will attempt to correct it.

Cherie

Originally Posted by Riverwild (Post 409189)

Mods, I'd appreciate it if you would lock this thread. It has run it's course and I would prefer it not be a battleground when it was started to provide information on what was learned at a seminar.