NeuroTalk Support Groups

NeuroTalk Support Groups (https://www.neurotalk.org/)

- Multiple Sclerosis (https://www.neurotalk.org/multiple-sclerosis/)

- - Seminar notes (https://www.neurotalk.org/multiple-sclerosis/59295-seminar-notes.html)

Sorry to be so late! You know me :o

RW has pretty much pin pointed on most of what was discussed.

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!

You usually hear the Pros from the Symposiums, don't you, Char. I guess they can't advertise the good stuff, because it doesn't work for all???

I don't know, anyway, thanks for your report..:hug:

Thanks for the info you two knuckleHAIDS! Wish I could've gone with ya. It's great that these type of seminar/info sessions are out there to enlighen/inform people. Glad you came away w/some info and ''goodies''. One can't have too many pens OR umbrellas. *hugs*

Quote:

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!

Yabbit is right, the answers about damage to the gray matter were very interesting. What the doc said was that even if you don't have any lesions showing on MRI, damage is still going on. You have to use a high TESLA MRI to image the gray matter and for many reasons ( usually cost is # 1) high T MRI is not available in many areas, but that he would assume that gray matter damage is going on, and treat the disease.

She also mentioned early treatment. This doc is of the school of treatment as early in the disease as possible. He stated " We do not have a time machine to show us the future, but we can go back and look at the past and the past shows us that the later you start treatment, the worse off you will be later in life, and we can gather from what we see in patients who were diagnosed earlier, before treatment was available, that they are doing worse than people who were diagnosed and started treatment soon after drugs became available for treatment, in the same time frame"

One of the things that was funny was when he stated that when he asks a patient how they are doing, he gets the usual "Fine, thanks" but then he finds out that they are skipping shots (months and months of them in some cases!) after he questions them further. it got a good laugh from the audience and a lot of sidways looks and blushing from a lot of people there! He reiterated how important it is to stay on treatment and to be honest with your doctor if it's not working out for you, so that you can discuss other options!

As far as what Yabbit said about only hearing the cons of the drugs, she's right on that point too! I wanted to jump up and shout that I have had 20 infusions of Tysabri and how well it's worked out for me! I wish the pt. advocate had showed up and done his side of the talk. I think it would have helped a lot of the folks there to hear/see the other side of the story

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:

Quote:

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!

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

Quote:

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

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! :)

Quote:

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.

Quote:

Originally Posted by Av8rgirl (Post 406490)

Actually I thought that was probably too high of an estimate, since Biogen said there were only about 6600 back in August:

http://209.85.173.132/search?q=cache...lnk&cd=8&gl=ca

But, I had run across a several articles that claimed 9500 (with 35,000 in total, same # RW mentioned), so I gave it those reports the benefit of the doubt:

“Last week, Biogen reported that 35,500 patients are on Tysabri at the end of September, with about 9,500 patients on the therapy for 18 months or longer.”

http://www.beurs.nl/nieuws/artikel.p...275803&taal=US
http://www.forbes.com/feeds/ap/2008/...ap5629776.html

Cherie

Quote:

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

These are commercial users of Tysabri. These are patients who have been on Tysabri since it was returned to market. Of the three people in the ORIGINAL trials before Tysabri was withdrawn from market, NONE of them were on monotherapy and TWO of them didn't have MS.

Of the three patients who have been reported to have been diagnosed with PML since Tysabri's return to market in 2006:

One patient had a TEN year history of azathioprine. That's not monotherapy. Imuran stays in your system. I cannot remember how many months it was before he started Tysabri. The fact remains that he WAS on Imuran prior to Tysabri, his neuro had him continue the Tysabri infusions despite his having problems and also administered steroids on top of that, as if treating a relapse without checking into it first.

One patient was treatment naive...NO treatment for MS at all. That is the one whose diagnosis of PML is in question at this time.

The US patient was treated with methotrexate with her last treatment 4 months before Tysabri. No further information is available for her due to the laws in the US concerning privacy. That's not monotherapy. Methotrexate stays in your system.

I am talking about commercial patients as stated in Biogen's own press release of their third quarter returns.
http://www.biogenidec.com/site/news-...PR_2008_36.htm

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.

As with each of the other DMDs for MS, it was a learning curve or did you forget that? Each one of them came out and people screamed about what the side effects were and what they could do to you. OMG, you could DIE from them!! Well guess what? People are injecting them into their bodies now regularly. Yet with every one of them, the future could NOT be predicted. Nor can the future be predicted with Tysabri.

Improved quality of life, no relapses for 19 months and counting, vision back to normal, no new lesions, no enhancing lesions, large lesions reduced or gone, no further progression, once a month infusion vs. a shot every day, other day or week, I'll stick with Tysabri, thanks.

Quote:

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.

I am that witness, Cherie what she said did come right from the rep's mouth! And also RW knows her stuff! She has done her homework plus more.

This thread was started to give information from a seminar that we attended to those who are interested.

Thank you, RW for your information and helping me with what I learned also. :hug:

Some thoughts here...

the title of this thread: seminar notes. That title alone would suggest to me, and maybe most others reading it that it is just that, notes from a seminar that someone attended.

Unfortunately, it has turned into another DEBATE about Tysabri dredging up the PAST and throwing in statistics about this and that and once again people who are NOT nor ever have been on this drug have to show off their internet savvy by posting all these statistics and links to articles that journalists have written when the whole purpose of this thread was....

two people's report on what they got out of an MS Seminar -- first hand.

It's getting to the point that every thread about Tysabri is turning into a debate again and those who are on the drug are being put into the defensive mode. That's just not right.

This madness has to tone down or stop. Information is good, that is not what I am trying to stifle, but once is enough. Hammering it again and again is pointless.

A couple of other points I'd like to make about this thread. The original poster, RW, tried to keep it short and pointed anyone interested in more information to the Tysabri sticky thread. Lady Express took it upon herself to change the tone of this thread to one other than the original posters' intent. Cherie, no one "owns" threads here but you have taken over this as you have in the past as a self-appointed Tysabri expert. No one is an expert about this drug, in my opinion, except perhaps the scientists who have invented and "own" the rights to this drug.

In my opinion, the people who take this drug have expressed their personal opinions and experiences with and about this drug and you continue to shoot stats and techno articles at them but you are NOT on this drug. Personal experience goes a long way against theory and you should know that better than anyone, as do I. We learn from our experiences. Might I make a suggestion for you to back off a bit and let those who attend these seminars report the information that they get from the doctors and the reps and not challenge them every step of the way? It would go a lot further for a more harmonious delivery of information and sure make life around here a lot more easier....

For the record, I have been on this drug, I have been on panels for the FDA critiquing the RISKMAP and have been very involved with this drug even though I cannot take it. I am not uneducated about it.

Who wants to see all this arguing? I can put up one of my famous polls???? :D