Tysabri info

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Postby OddDuck » Wed Feb 23, 2005 11:04 am

As a side note, in another post somewhere, Wesley pondered as to why other high profile professionals and experts (who "read" this site often) didn't or wouldn't post.

Gee...........I wonder???

Deb

P.S. Don't worry, Arron. That's all I have to say.
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Postby HarryZ » Wed Feb 23, 2005 12:12 pm

Arron,

Arron wrote:To play devil's advocate, note that the article in question was translated from the original Dutch. There is a distinct possibility something was lost in translation.


That was the first thing that I thought about because foreign to English translations don't always pan out the way they should. But at the same time, the person who posted that article perhaps should have realized the kind of reaction some MS patients might perceive when reading information about a medication that implied a guarantee!

Take care.

Harry
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Postby DenverCO » Wed Feb 23, 2005 12:17 pm

OddDuck,
If by "experts and professionals" you are referring to physicians and researchers in the field of MS, then I can see why they don't post here...if they even read this stuff in the first place. We are not authorities on MS, the drugs used to treat MS, or the research that goes into developing those drugs. You give your OPINIONS way too much credence if you think that MS "experts and professionals" give a second thought to alot of what is written here. I think you mentioned something in another post about NMSS executives using this site as a resource for keeping their fingers on the pulse of the real MS experience. Don't you think they get enough "MS" at the office? I really doubt that they run home at night, fix themselves a martini, and eagerly tune into ThisIsMS for the latest episode.
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Postby amelia » Wed Feb 23, 2005 1:02 pm

I know politics plays a lot these days in decisions, BUT it still comes down to WHY DID THE FDA QUICKLY APPROVE THIS DRUG? There had to be something phenomenal there. Yes, maybe some politics involved. I don't think Biogen had enough pull to "market" their way through the FDA. Besides, it really doesn't matter to me too much about what experts and doctors know about the effeciency of the drug as much as what it is actually doing to help someone with MS. That is where this board is great. I want security. I'd be stupid otherwise. But also HOPE. I know the possiblty is maybe or maybe not on helping my husband on Tysabri. But I already know where he is without it or anything else. :wink:
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Postby OddDuck » Wed Feb 23, 2005 3:16 pm

Denver,

Okey dokey. You are 100% correct. There, do you feel better?

I will tell you one thing, though, which I'm certain others here of integrity and character can attest to, we do not call each other a liar.

You sound very much like a couple of other people who not long ago were banned from this site. hmmmmmmmm..........

Frankly, I don't care what you believe or don't believe. Those who DO know me here, know differently.

Oh...and by the way.....you're right. I don't know why I'm going home and tuning in here. I better re-think that myself and follow my colleagues' (i.e. fellow professionals) lead, I guess!

EDIT: Oh, and I'm sure Art Mellor from Boston Cure would love to hear your comments, also (he also "tunes" in here). Maybe you took a wrong turn, Denver, and ended up at the wrong location?????
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Postby amelia » Wed Feb 23, 2005 3:34 pm

Excuse me? I am new here. I am a family member and I do believe that you have hurt my feelings. I thought this was a place I could talk to others about MS other than my lonely little town in Mississippi. I have been reading all of this and was just stating a point. You can ask Harry and the moderator, I am new here.
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Postby OddDuck » Wed Feb 23, 2005 4:42 pm

amelia,

I'm not sure who you are talking to, but if it is me, I was talking to DenverCO. (See, my post starts off by addressing that person by name.) I'm sorry if you thought it was you I was talking to. (If it is me you are referring to.) I was answering Denver's comments that were directed to me a couple of posts ago.

You'll get used to that (i.e. several conversations going on at the same time, and not always to everyone on the thread as a group).

I will warn you, though, that there are some people who do come on this website (we have gotten rid of them before, though) who do deliberately try to demean you and hurt your feelings. I'm not one of them, amelia.

Go back and read Denver's words in his/her last post. S/he is the one who is getting a little bit outside of the word "respectful".

There are many people on here who are wonderful. We are a very good group (with the exception of just a person now and again who pops in to try to ruin the site, insult us members, etc.), but that usually doesn't last long.

Please..........nothing was directed to you at all. And we certainly do welcome you to the site. (But again, I will let you know that some conversations under some categories will sometimes get a little "rough". My feelings have been hurt many times.)

Hang in there! And welcome, again!

Deb

EDIT: But I will stand up for myself if someone attempts to insult me PERSONALLY, which is what is transpiring between me and DenverCO. I'm not attempting to sway anyone's opinion about Tysabri or Biogen. I'm attempting to prove that I form my OWN opinions from detailed research, etc., not that I'm full of crap, like Denver is boldly saying. That is a "personal" insult to a member of this Board. I would just as quickly stick up for you, also, if someone attempted to attack you "personally".

Just as there are MANY people who LOVE Biogen and Tysabri, there are a couple of us who don't. It's still a little uneven (pro-Biogen's versus anti-Biogen's), but personal "potshots" should not happen here. If it is thought by anyone that I am "lying", than they should keep that "personal" opinion to themselves. That's what I mean by "respect".

Again, nothing is directed to you or to you personally at all.
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Postby DenverCO » Wed Feb 23, 2005 5:46 pm

Amelia,

Welcome aboard! You will love the good wholesome fun that is available right at your fingertips with this site.

But since the topic of this thread is "Tysabri", allow me to agree with your statement that the FDA would not have fast tracked this new drug if there was not evidence that the benefits to MS patients outweighed the risks.
I also couldn't agree with you more that Hope is of the utmost importance when dealing with a disease like MS.
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Postby OddDuck » Wed Feb 23, 2005 5:56 pm

I also couldn't agree with you more that Hope is of the utmost importance when dealing with a disease like MS.


Denver, don't have a heart attack here, but I sincerely totally agree with you on that one! :wink:

Ok.........I'm bowing out of this thread now. Again, welcome, amelia (and hopefully, "truce", Denver? Let's just "agree to disagree".)

Best always,

Deb
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Unexpected side effect for Tysabri !

Postby better2gether » Fri Feb 25, 2005 12:06 am

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Unexpected side effect for Tysabri !

Comment from another MS board...

" Thanks to all of you, thank you, thank you, thank you, thank you....

I was scheduled yesterday for my first Tysabri infusion. Of course, Monday night I was a basket of nerves! Your posts, the positive and not so positive, calmed me immensely! And this is why, when anyone calls me with an MS problem or situation, I send them here and have for about a year.

xo, you helped my husband not only relax but gain a better understanding of what Tysabri could be doing for me. Thank you with all of my heart.

Now, the infusion. Whats the word for when something gives you a false sense of amazingness? That's the side effect of the infusion I got.

The only side effect, and felt it as I was leaving the hospital, I wanted to hug all the nurses!

Or- maybe I really feel amazing, better than I have in two years!

I had to make myself take a nap today only because I had to take my mother to the airport at 4 this morning. Otherwise, this would have been the first day in about a year that I didn't feel like a zombie by one in the afternoon.

I can't wait to see what tomorrow is like! "
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More Unintended side effects

Postby MeadowStream » Fri Feb 25, 2005 5:04 am

There are also stories of people with brutal rheumatoid arthritis who now do not suffer from that either after taking Tysabri for their MS. That is a nice side effect!

Amelia, welcome and try not to let other's emotions affect you here.

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sorry

Postby amelia » Fri Feb 25, 2005 7:34 am

Odduck,
I did see who it was posted to AFTER I posted. Sorry. I know that everyone is trying not to get too optimistic on this. But I do. I still have all the confidence in the world that there will be a cure or complete control for MS REAL soon. I have to. Gary is barely holding his own. We have lost so much to MS and I do stress WE! My daughter, now recently married, lost her normal childhood to it. All through this I still believed there would be a cure soon. For me, it is the ONLY way to make it day to day. I guess that is why I believe in the Tysabri as much as I do. Heck, it is new and shows some good progress. Our treck with MS started with ACTH and Solumedrol as the ONLY treatments for MS and nothing to slow it down. See things are getting better. Tysabri will bring out even better treatments, I do believe
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briefing.com on TYSABRI

Postby better2gether » Wed Mar 16, 2005 1:31 pm

03/16/05 09:36 am

BIIB Biogen Idec at SG Cowen Conference

Co continues manufacturing activity for Tysabri but at a slower rate; infrastructure still helpful for Avonex business... one confirmed report that was treated as a PML case; both patients were on the combination therapy for two years; had not shown any signs of health risks before this... will take all other people in the clinical trial and redetermine what really is the risk, any other smuldering cases, see if they can ID what group is at risk, how can it be diagnosed; expect review to last a few months due to logistics... co has reviewed Avonex cases and has never seen a case like that, FDA states they have never seen PML cases develop in a study like this...

Co states they have a long pipeline: have 'a lot more irons in the fire'... 10-K filing will be end of March; full results from Tysabri study will be released in the next couple of weeks... vast majority of patients remain in trial network so will be able to re-evaluate; co says it is too early to speculate, if what they see is the extent think there is a fast forward to end of the study, if there are more problems obviously will take longer to study... co says they have a lot of disappointed and depressed patients out there... no possibility that they will have information at the AM...

Co says at this stage they are not prepared to say this product isn't coming back and won't becoming back as an important product; the only thing that will be written off is any immediate inventory; manufacturing expense is fixed costs; commercial costs related to marketing, development, etc currently do not exist, so not a huge number; will keep salesforce out there; the only thing that will change companies motion is if something big comes out of research and it is too early to foresee anything or to comment on anything.
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Postby Arron » Wed Mar 16, 2005 1:39 pm

great information-- thanks!
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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GSK's drug delayed

Postby better2gether » Fri Mar 18, 2005 10:36 am

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GSK's drug delayed

GlaxoSmithKline: COX-II fallout dents MS hopes

The FDA has halted a Phase II trial of a GSK multiple sclerosis drug.

March 17, 2005 6:31 PM GMT (Datamonitor) - The US Food and Drug Administration (FDA) has suspended Phase II clinical trials of GlaxoSmithKline's (GSK) multiple sclerosis (MS) and Crohn's disease drug 683-699 because it belongs to the same class of drugs as Biogen-Idec/Elan's recently withdrawn Tysabri (natalizumab). This is an overcautious move by the FDA stemming from the recent heightened scrutiny of drug safety.

The FDA has taken the precautionary measure of halting the Phase II trials of GSK's 683-699, a beta-7/alpha-4 beta-1 integrin antagonist, which displays a similar mechanism of action to the MS drug Tysabri. The decision is due to the uncertainty surrounding the cause of a brain disease called progressive multifocal leukoencephalopathy (PML) in patients taking a combination of Tysabri and Avonex (interferon beta-1a), which resulted in a total ban of Tysabri marketing and clinical trials.

To date, there is no hard clinical evidence suggesting that Tysabri monotherapy is associated with an elevated risk of PML.

Furthermore, although 683-699 has the same molecular targets as Tysabri, the drug is not a monoclonal antibody and is therefore chemically unrelated. Additionally, 683-699 is one of the many MS drugs in development that can be administered in an oral pill form while Tysabri is a biological compound given via injection.

Considering the limited evidence available for Tysabri and 683-699 monotherapy, the FDA's move seems somewhat drastic. The intervention will certainly delay the development of 683-699 by at least a year.

This latest move further highlights the FDA's increased sensitivity over drug safety in the wake of the COX-II controversy that has enveloped big pharma in recent months. Manufacturers wishing to gain approval for an MS drug will now certainly have to produce safety and efficacy data from clinical trials lasting at least two years. The regulator is also likely to demand stricter labeling controls on drugs on the market - indeed, beleaguered Biogen-Idec's Avonex is one such product that will carry revised labeling after it was linked to rare cases of severe liver injury.

Yet the crux of the matter is that many of the most efficacious drugs on the market carry a certain risk to the patients that take them. The FDA needs its drug labeling procedures to ensure patients are suitably aware of potential concerns about their treatment, and the approval process must be sufficiently robust to prevent the approval of new products where the risks manifestly outweigh the medical benefits. There are no signs yet that this is the case for 683-699.
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