[sheena]

When I last saw my neuro he gave me 6 choices of meds. I stated I wanted the best and most aggressive drug. Tysabri was his choice by far and I did the paperwork... I was told there had been 2 deaths, but one was a person with HIV and the other herpes. I'm fine there. However after research, it seems there have been atleast 6 or 7 die, and many others with severe problems after. Is this really true - I read it here and it seems to be backed up. I know all had a suppressed immune system, but mine is not the greatest. I'm COPD which he said was fine, sick a lot, need to go back for more tests on my B12 as it was off. I want the best, but I don't want to end up a veg. I feel like I can take a risk on death but not on getting worse or getting something else. Thanks so much ~Sheena~

[lady_express_44]

Your doctor told you the truth about Tysabri being the most statistically effective drug on the market approved for RRMS. The part about the other patients who died having HIV and herpes is not true however.

The facts, as we know them, are in the following posting:

Originally Posted by lady_express_44

You are WAY too early in this game to be considering as aggressive a treatment option as Tysabri, or multiple doses of steroids. I'm not sure where you've been getting your information up till now, but I would strongly suggest you do MUCH more research before you make any further decisions.

Tysabri has only been on the market for a couple of years as it was pulled off (after being fast-tracked) because 3 people came down with a usually fatal disease, called PML. They suspect that this very rare disease was caused by the patient's weakened immune system (they were all either on a combination therapy, or previously used strong immunosuppressants), but to this day the manufacturer has many warnings about the unknown long-term effects of this medication.

There are still reports filtering in every few months about people having rebound reactions (if pulled off the drug after just a few infusions) and the potential risk for skin cancer from this drug. In fact, someone on another board recently advised us that their neuro was aware of 4 new PML cases, yet to be announced. THIS IS JUST HEARSAY (not yet confirmed!!!), but it was the rumor-mill that revealed the last 3 cases too (just shortly after the manufacture's execs sold off boatloads of shares, THEN kindly announced the potential problem).

There are some neuro's out there that are gung-ho on Tysabri, but this treatment option is still meant to be reserved for those people who have an inadequate response, or who are unable to tolerate other approved therapies.

I have had MS 17 yrs, and before there was access to any "disease modifying drugs" (DMDs). Since there has been though, it has always been recommended that a person try one drug for a period of approximately one year, before they consider a decision on whether the medication is working for them, and/or if the side-effects outweigh the personal benefits. You are only ONE MONTH into this, and you haven't even tried the interferons (the "big guns"), so I am not sure how you could already come to the conclusion that Copaxone is not the drug for you.

I understand your neuro discussing the potential problems with the interferons (due to your history of depression), BUT that does not mean that Betaseron, Rebif or Avonex will necessarily effect you this way. There are probably 100's of thousands of people around the world that had no other choices until recently, and many of them did just fine on the interferons (even with a history of depression).

All of the drugs we have available to us only work on SOME people. Even though we have averages of "30%" or "68%" efficacy, there are some that are perhap seeing a 100% reduction in relapses, there are others that the the drugs do nothing what-so-ever for. Copaxone might seem to be the drug for one person, and Tysabri seems to work for the next.

In fact, due to the unpredictability and relapsing remitting nature of this disease, it is very hard to know if any drug is helping any one of us reduce relapses at all. Additionally, even though we might be seeing a reduction in relapses, there is still no direct correlation between this reduction and a reduction in disease progression. Hence, the disease process/disability may do EXACTLY what it was going to do, with or without these drugs.

I will answer your steroids question on the other thread . . .

I am not telling you this to scare you, or to put down Tysabri or any other drug. I have had MS and have been on these forums a LONG time, and I probably still don't have all the facts right. However, my point is that you are obviously getting very biased input from your neuro/specialist, so I feel we would be doing you a disservice if we did not advise you to do your own personal research before you jump on any bandwagon so early in the game.

Cherie

The rest of this conversation is in the attached link:

http://neurotalk.psychcentral.com/thread38842.html

The 3 people who got PML were in the trials, before the drug was brought to market. We didn't find out about the deaths until after it was fast-tracked to market, and the execs sold out their shares though.

Two of the people were in the MS trial, and both were on combination therapy with Avonex. The other person was in the Crohn's disease trial, going on at the same time, and he was not on combination therapy. His immune system was compromised, perhaps, because had been on a immune suppression drug prior to going on Tysabri.

When they warn against using this drug with a suppressed immune system, they are generally referring to suppressed as a result of another drug.

I was one who argued hard back then about ensuring there was protocol in place to warn (especially newbies) about the potential risks with this drug. Sounds like the neuros are making up their own versions of the story and not following the proper protocol of trying other drugs first though. I predicted that was going to happen . . . just like people aren't sometimes advised of the risks associated with the use of steroids or CRABs. It's to be expected, really . . .

The good news is that there are apparently quite a few people who are doing very well on Tysabri, and we have had no confirmed evidence that it is causing considerable harm to anyone since it came back to the market.

Cherie

[RedPenguins]

Sheena -

I've never heard the herpes or the HIV thing before in regards to previous deaths involving Tysabri.

There were two deaths from JPL when tysabri was given with avonex before. Since its re-release, no deaths reported from that virus. There have been two deaths recently from melanoma - however, they can not 100% attribute it to the tysabri. It sounded to me as though both of those patients had either family history or prior issues with skin cancer, etc. If you look on the fda's website - it discusses these deaths. I believe NMSS also has it on their site.

My paperwork has been filled out and sent to TOUCH/Tysabri - and I'm eager to get on it.

Yes, these drugs mess with our immune system - and all drugs have risks. You need to weigh them out and decide which risks are worth it to you. I imagine that when you take anything that messes with your immune system, you are leaving yourself exposed to any slew of complications....

I decided that I am not afraid of death - I am more afraid of living with big question mark over my head (or ticking time bomb - that doesn't have a timer - and I don't know when or even if it will ever go off) - that is how I'm beginning or trying to see the MS. When I read about Tysabri - I know it isn't a miracle cure...but it seems to be one of the best out there - and that if it works for you - it REALLY works. But it doesn't work for everyone...nothing works for everyone. There are several reasons I am not going on interferon treatments - and I did copaxone for a month - and my doctor and I discussed that it probably wasn't the most aggressive or worthwhile treatment for me.

Have you been to msworld - and read their forums as well? There's a whole bunch on neurotalk and msworld about tysabri. I think i've read everything. Also, there are some tysabri diary sites - where people have shared their experiences taking it, too....some people who have had 15+ treatments. I have tried to read everything I can...though at this point, I am going to try to step back a little bit....(which is hard...but I don't want my life to be ONLY about MS....though right now it certainly feels that way).

I'm sorry it feels like your doctor lied to you - I would ask him about it - and ask him to clarify and explain things - so that you can make the best informed decision that you can make. Have you been to tysabri's website? (just add .com after the drug's name) - I think they address the deaths, too.

This is serious stuff - and should be thought about and discussed. There is lots of info out there - and I try to find the most reliable sources I can find (NMSS, FDA, etc). I think the info I provided is accurate - but I dunno - so double check everything I said! My brain doesn't work the best these days! LOL. Something bout having holes in your brain that causes problems!


And Tysabri isn't your only choice. You might respond well to one of the other treatments out there. Like everyone here has said - none of us know the course of our disease until we experience it, for the most part. I plan on being as aggressive as I can - and my choices right now are a little more limited b/c I am unable to take the interferon treatments - so it's between copaxone and Tysabri. Like I said - I did copaxone for a month (just stopped a week ago so I could wash out my system for tysabri)....and I decided I wanted to try Tysabri.

It is a personal decision. and while your doctor can advocate for certain treatments - in the end, you get to make the decision that is best for you in this case...especially b/c they all carry their own risks.

What are your thoughts right now?

~Keri

[RedPenguins]

Cherie -

Looks like we just cross-posted...

I wanted to tell you - that I have really taken to heart a lot of things that you have said (written)......I've read most of the threads on this site and msworld going way back.............and I really appreciate your thoughts and concerns.

And I try very hard to hold onto the fact that it is TOO early to tell anything yet. Of course, even holding onto that knowledge - or trying to - doesn't lessen the pain, shock, sadness, fear, etc. that I'm experiencing right now. And I truly believe that right now that is just the process I have to go thru and that it will run its course - just as the disease will - and then I will have a better idea of what the heck is going on....

And I read what you said in response to my Tysabri post (over a week ago, I believe...that you re-posted her for Sheena)....I'm still deciding to go with it - but I think I'm making as informed a decision as I can make right now....and of course, I can always change my mind at any point in time, right?

I'm glad you're here, Cherie...

~Keri

[lady_express_44]

Originally Posted by RedPenguins

Cherie -

Looks like we just cross-posted...

I wanted to tell you - that I have really taken to heart a lot of things that you have said (written)......I've read most of the threads on this site and msworld going way back.............and I really appreciate your thoughts and concerns.

And I try very hard to hold onto the fact that it is TOO early to tell anything yet. Of course, even holding onto that knowledge - or trying to - doesn't lessen the pain, shock, sadness, fear, etc. that I'm experiencing right now. And I truly believe that right now that is just the process I have to go thru and that it will run its course - just as the disease will - and then I will have a better idea of what the heck is going on....

And I read what you said in response to my Tysabri post (over a week ago, I believe...that you re-posted her for Sheena)....I'm still deciding to go with it - but I think I'm making as informed a decision as I can make right now....and of course, I can always change my mind at any point in time, right?

I'm glad you're here, Cherie...

~Keri

I remember my feelings of distress too, Keri. It was a very long time ago, but unfortunately it's not like having a baby (where you forget about that pain when it's all done). The physical and emotional pain from this disease is etched very clearly in my mind.

I understand and support your decision, knowing that you have done your own research and are fully informed. That's all I am really trying to achieve when I provide negative information about any part of this disease or our medications.

I sincerely hope it works wonderfully for you.

Thanks, Cherie

[sheena]

I agree with everyone here that I need more education and I am working hard on it. I have taken all advise and links I have found in the last short time.

Lady - you make highly educated and excellent points. I also feel, after my neuro's comments, that they are doing just as you have stated. I went back and looked for the comment I thought I saw ref. HIV. I didn't find it so maybe my mind is playing tricks. I have noticed a little of that, but I know 100% he did say 2 due to HIV and herp. Since, I am HPV I even had to state such at that time. But, he did not force me to select Ty. So, I guess I can give the jerk a little slack.

Erin - I just don't feel that I have anytime to waist. I must be aggressive and work as fast as possible. I read a little of Estriol early yest and it does look very good. It may well be my 1st choice after Ty. I was not given an option of this. Isn't it still in testing or atleast early sage? Unsure

I have made a decision and while I have and will continue to research more, I'm going with Tysabri. Why is sinple and I could never put it better than Red when she stated "I decided that I am not afraid of death - I am more afraid of living with big question mark over my head (or ticking time bomb - that doesn't have a timer - and I don't know when or even if it will ever go off) - that is how I'm beginning or trying to see the MS." That is the way I have always seen ms. I am a black and white person. For me there can be no grey. Now for me now there is nothing but grey. That is why MS is so hard to accept. I know it, I am coming to understand more of it, I will face it, I will fight it, but to accept it is impossible. This is just my personity type. Thank you and to all ~Sheena~

BTW - sorry for the typos and sp - my mind just is not like it was 1 mo ago. Pls excuse.

[Erin524]

Originally Posted by sheena

When I last saw my neuro he gave me 6 choices of meds. I stated I wanted the best and most aggressive drug. Tysabri was his choice by far and I did the paperwork... I was told there had been 2 deaths, but one was a person with HIV and the other herpes. I'm fine there. However after research, it seems there have been atleast 6 or 7 die, and many others with severe problems after. Is this really true - I read it here and it seems to be backed up. I know all had a suppressed immune system, but mine is not the greatest. I'm COPD which he said was fine, sick a lot, need to go back for more tests on my B12 as it was off. I want the best, but I don't want to end up a veg. I feel like I can take a risk on death but not on getting worse or getting something else. Thanks so much ~Sheena~

My suggestion would be to try the one that has the least side effects first (as far as I know, that's Copaxone). Then try the others and work your way up to Tysabri.

There are a few other treatments than the CRABs and Tysabri. I dont know if it's on the market yet or if it's still in trials, but there's something called Estriol that's been said to work fairly well. (it's a type of estrogen) I'm pretty intrigued by that one.

There's also something called Low Dose Naltrexone (LDN) that sounds pretty promising to me too.

I'm planning on asking my neuro about the Estriol and the LDN at the beginning of May when I go back to see him. (unless I see him sooner, seeing as I might be in a tiny flare right now...)

Please, do as much research as you can about the CRABs and the Ty and the other stuff...dont just go off what the neuro says, and dont think that we're trying to talk you out of doing the Tysabri, because I dont think we are...We all just want you to have a bit of knowledge before you pick what treatment you want to try first.

I held off on a treatment when I got diagnosed in January 2007 because I wanted to read about all the different drugs before I chose one. I picked Copaxone mostly because the thought of having the "flu" every week didnt sound so appealing. The C isnt all that great either, since it's a daily injection and for me the shots are itchy, and kind of remind me of bee stings. (not everyone gets that reaction apparently)

I didnt choose the copaxone until after I had my second opinion at the MS Clinic here in town. They wanted me to try Avonex. But, they didnt try to talk me out of Copaxone. They just wanted me to get started on one.

I dont think it matters which CRAB you take first, as long as you get started on one that will hopefully hold back the little MS Trolls and keep you from having flares.

[Riverwild]

Originally Posted by sheena

When I last saw my neuro he gave me 6 choices of meds. I stated I wanted the best and most aggressive drug. Tysabri was his choice by far and I did the paperwork... I was told there had been 2 deaths, but one was a person with HIV and the other herpes. I'm fine there. However after research, it seems there have been atleast 6 or 7 die, and many others with severe problems after. Is this really true - I read it here and it seems to be backed up. I know all had a suppressed immune system, but mine is not the greatest. I'm COPD which he said was fine, sick a lot, need to go back for more tests on my B12 as it was off. I want the best, but I don't want to end up a veg. I feel like I can take a risk on death but not on getting worse or getting something else. Thanks so much ~Sheena~

Tysabri was removed from the market after three people developed Progressive Multifocal Leucoencephalopathy or PML. PML is caused by the JC virus, something 80% of the population carries in their system.

Out of those three people, two died.

One was a Crohn's patient who was on a combination of immune suppressing drugs for YEARS before Tysabri. Some of the drugs included Remicade, azathioprine and steroids. After digging the poor soul up, ( death was two years before Tysabri was withdrawn) and a lot of investigation, the FDA Adverse Events Register reports that the cause of death is suspected to be from PML due to Remicade.

The second patient was a woman who may not have had MS at all. There is some question as to whether she had PML evident already. She was also on a combination of Avonex and Tysabri. Even the experts cannot agree as to whether she had MS. Regardless of what she had, she died after being treated with a combination of drugs.

The third patient is still alive, although severely disabled from PML.

To date there are over 24,000 patients on Tysabri with NO further signs of PML. Many are reaching the 18 month mark of treatment.

I am not sure where HERE you read that 6-7 more people died from it. I'd like to read that post.

72% of people taking Tysabri had no flareups at the end of a two year study.

83% of people taking Tysabri had no disease progression at the end of a two year study.

Tysabri reduced EDSS progression by 67% in a two year study.

Tysabri reduced the number of lesions by 92% in a two year study.

As with every other drug on the market today, not everyone can take Tysabri, and it may not work the same for everyone. It is designed to REDUCE RELAPSES and SLOW PROGRESSION OF ALL FORMS OF RELAPSING MS.

If you need more information, please PM me and I will supply a box full of studies and more people you can speak with, along with Tysabri blogs and You Tube videos that you can watch from other patients who are on Tysabri.

As with all treatment, it is YOUR choice how YOU treat YOUR MS.

There is also a "sticky" at the top of the forum for people who are on Tysabri. You might read there for more personal observations.

Time is brain.

[sheena]

River - what I saw was a comment here by Sally C. on 12-15-06
"According to the WSJ article, by staff reporter Sylvia Pagan Westphal:
The analyst's report describes seven non-PML deaths in patients taking Tysabri that "appear to be related to immunosuppression." One death was owing to pneumocystis pneumonia, an infection that only patients with severely debilitated immune systems get; another was because of herpes encephalitis, a rare infection of the central nervous system. Four other deaths were possibly caused by sepsis, an uncontrolled infection that spreads through the body. The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri extends beyond PML." I have too few posts to link but ...
drug-injury.com/druginjurycom/2005/09/analyst_report_.html

I'm by far an expert but to me this looks like 7. If correct or not I'm am still going TY. What does concern me is "The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri extends beyond PML."

[SallyC]

Here is my post and the article that Sheena is talking about.

http://neurotalk.psychcentral.com/post50100-85.html

Originally Posted by sheena

River - what I saw was a comment here by Sally C. on 12-15-06
"According to the WSJ article, by staff reporter Sylvia Pagan Westphal:
The analyst's report describes seven non-PML deaths in patients taking Tysabri that "appear to be related to immunosuppression." One death was owing to pneumocystis pneumonia, an infection that only patients with severely debilitated immune systems get; another was because of herpes encephalitis, a rare infection of the central nervous system. Four other deaths were possibly caused by sepsis, an uncontrolled infection that spreads through the body. The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri extends beyond PML." I have too few posts to link but ...
drug-injury.com/druginjurycom/2005/09/analyst_report_.html

I'm by far an expert but to me this looks like 7. If correct or not I'm am still going TY. What does concern me is "The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri extends beyond PML."