Living With MS

Discussing all aspects of Multiple Sclerosis, various treatments, including accurate information regarding Tysabri.

Wednesday, January 17, 2007

Just a quick update today...the Australian website "OzMS" has published my Blog, and I was requested to write a short article as well re: Tysabri. Gosh, how sweet is that???

I had previously written an article at the request of The Washington Legal Foundation just prior to Tysabri's re-approval by the FDA in June, '06. The link for same is listed below, and here is my Addendum to said article which appear in "bold black letters" below to distinguish same from my updated 2006/8/22 post - I hope this is helpful to all who read it:

updated from 2006/8/22 11:39:00 post:



Hi all, My name is Lauren. I have been living with MS for 31 years (lucky me!). I have been on Avonex and Copaxone, oral and IVSM (which no longer work for me) and Novatrone is not an option for various reasons.

I had one dose of Tysabri in early 2005, and after it was removed voluntarily by the manufacturers, I suffered a severe relapse in June 2005 that has left me w/c bound and homebound. I was RRMS for 29 years (I was amazed and grateful I remained RR for so long, my neuro was shocked and baffled-lol) up until last year when my neuro upgraded me to SPMS with relapses. When I was not so disabled in early 2005, Tysabri was the only MS therapy that stopped my attacks, improved my symptoms dramatically within 2 weeks of the infusion, and provided me with a better QoL.

Thankfully, Tysabri was re-launched here on 6/5/06, and the TOUCH program went into effect on 7/18 (scheduled training of neuros and infusion centers) with enrollment forms being accepted and processed by Biogen on 7/19.
I am currently on Tysabri, again with my 1st dose in Oct. '06, and my 4th scheduled for 1/19/07 - and while I am not receiving dramatic improvements this time around (I believe this is due to being more severely disabled as of June, '05)...Tysabri has still stopped my attacks and has still halted my disease process! :)

I don't care how many infusions it takes - Tysabri is still the most effective MS therapy available and it will always give me Hope!


I will support anyone's choice of MS therapy, no matter what that choice is. I would, however, like to set the record straight due to any misconceptions and/or mis-information regarding Tysabri. I also testified at the FDA AC hearing via videotape on 3/7/06 in an effort to bring Tysabri back to MS sufferers that want and need it, like I do. If you would like to view my videotaped testimony (try not to die laughing, ok? LOL), it's on the homepage of the website: http://www.mspatientsforchoice.org/ (of which I am a very proud member).

In a nutshell, for me,Tysabri's 68% superior efficacy, improvements in current disabiities, safety when used as a monotherapy (by itself as a sole therapy), improvements in Quality of Life (which no other MS drug can claim) and protection from further relapses: the benefits of Tysabri far outweigh the very small risks of contracting PML (.01% or 1:1000-probably less than that, actually). It is more of a risk for me NOT to have Tysabri, as Tysabri protected me from further attacks/relapses.

For more information on Tysabri, see http://www.biogen.com/site/home.html , http://www.elan.com/, and http://www.tysabri.com/touch.html.

As to Tysabri being used as a First Line AND/OR Second Line therapy, NOTE: Dr. Richard Katz and Dr. Temple of the FDA (specifically Dr. Katz) indicated in his Conference Call shortly after Tysabri's re-approval, that the language in the FDA formal statement re: Tysabri's use was to be decided by the treating doctor and the patient (as it should be) and the FDA's formal statement[1]was intentionally left open for indications of use as First AND/OR Second line therapy. In order to bolster this argument, I highlight in bold the text from the FDA approved label for Tysabri which states in part, "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."

[1] http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html

Tysabri = to shelter (abri in French).... Is that the perfect name for a MS drug that "shelters" patients from further relapses & disabilities, or what? :)

If you have a neurologist that has taken a "Wait and See" attitude, ask yourself, "What is he/she waiting for? For you to get worse???

For any MS patient or treating neurologist reading my comments, I ask you this question: If "Time is Brain", why are neurologists willing to allow their patients to suffer relapses, increased likelihood of further lesion load, possible permanent disability and possibly develop "black holes" therefrom, BEFORE they will prescribe Tysabri to protect their patient by 68% or 2/3rds efficacy over the 1/3 possible efficacy of the ABCR's?

Please feel free to leave me a comment. I do try to check my blog site daily. You can also reach me at: LGLBGL2003@AOL.COM, (the Legal Beagle...laughing). You can also visit my homepage at: http://hometown.aol.com/lglbgl2003/myhomepage/profile.html.

In the prior posts on my Blog, I had been keeping a diary of what I was going through in my own personal "Tysabri Saga" of endless delays and run-arounds, in addition to having difficulties typing...but now that my Tysabri infusions have started again, I'll update everyone as much as I can (boring huh? lol)

Being diagnosed with MS is not the end of the world (at the time I was dx'd in 1976, it came pretty dayum close though!!!). Whatever any of you decide to do re: your choice of therapy, I wish you only the very best that life has to offer. May you always be blessed, Lauren.

additional links:

My Home Page: http://hometown.aol.com/lglbgl2003/myhomepage/profile.html

MSPatientsForChoice (including Tysabri Patient Progress Reports): http://www.mspatientsforchoice.org/

*** Addendum (current) to this article is at the end of this post *** Washington Legal Foundation Published Legal Opinion Letter: http://www.wlf.org/upload/051906robertsLOL.pdf

Tysabri Info & The TOUCH Program: http://www.tysabri.com/touch.html

Elan (Discovered Tysabri) & QoL News: http://www.elan.com/News/full.asp?ID=840112

What Is Multiple Sclerosis?: http://www.nationalmssociety.org/What%20is%20MS.asp

MS Chatters (TONS of Links about MS): http://www.nytedancer.com/MSChat/index.html

National Patient Advocacy Foundation:
http://www.patientadvocate.org/index.php

RemedyFind (Patient Ratings of Tysabri:
http://www.remedyfind.com/treatments/21/1259/

***Addendum to the article I wrote***: "Subsequent to my article being published, Tysabri's sponsors Biogen/Elan submitted the following outstanding data on Tysabri:

1. TYSABRI® Has Sustained Effect on Relapse Rate for up to Three Years, http://www.elan.com/News/full.asp?ID=910437

2. TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations, http://www.elan.com/News/full.asp?ID=9130123

3. TYSABRI® Demonstrate Significant Improvements in QoL, http://www.elan.com/News/full.asp?ID=840112

4. TYSABRI® Demonstrates Improvement in Cognitive Function, http://www.elan.com/News/full.asp?ID=910099

Furthermore, data from the world renowned and highly respected opinions of the New England Journal of Medicine believe that: "progressive multifocal leukoencephalopathy (PML), a rare but deadly viral infection of the central nervous system (CNS) [has been] associated with immunosuppression. Owing to the effect of natalizumab on central nervous system leukocyte recruitment, the emergence of PML has been attributed to diminished immunosurveillance. The lack of additional opportunistic or CNS infections among natalizumab-treated patients, however, suggests that alternate mechanisms may contribute to the infectious risk" - (NEJM Neurol Res, April 1, 2006; 28(3): 291-8)

I'd say that pretty much clears Tysabri's good name!

If patients or their neurologists are not comfortable with the findings of some of the most respected doctors in the world, then they have the option to wait until they are comfortable to use Tysabri, but hopefully they will wait with the understanding the true risk the patient takes of having a severe relapse that hits them out of the blue (like mine did in June'05) and possibly leave permanent damage and disability without Tysabri, which could have been avoided with it's superior efficacy and protection.

Tysabri does not destroy cells, it protects our myelin and helps to stop the cascading effects of a majority of the damaging T-cells (inflammation cells) from crossing the BBB (Blood Brain Barrier) and entering the CNS (Central Nervous System) and thus, protects us from them attacking our myelin (which results in the disabilities/damage and lesions we suffer) - and even if a few of those T-cells are still able to cross the BBB into the CNS, Tysabri is able to move (migrate) them away from our myelin - protecting us even more!

I am of the opinion that knowledge is power, and patients need to be their own advocate. This is accomplished with knowledge of our condition, and all options of therapy.

These are our bodies, our lives, and MS is our disease...we should have the option to choose the best medication available as our therapy to treat same.

We have the right to have hope again, the hope that we can gain back (some or all) of what MS has taken from us...the hope that we can a better Quality of Life and have our lives back....and that Hope equals Tysabri."


(((hugs)))
Love, Lauren
A very proud member of www.MSpatientsforchoice.org

3 Comments:

  • At 9:00 AM, Blogger mdmhvonpa said…

    MOST EXCELLENT! Yet another MS Celebrity! :)

     
  • At 7:19 PM, Blogger Lauren said…

    LOL mdm, nah...just an informed MS patient...(((hugs))) Lauren :)

     
  • At 12:04 AM, Blogger lynne said…

    I am thankful to have a neurologist that believes Tysabri improves MS patient lives. I will be a first user of Tysabri. Of course I was suppose to start my first infusion. I came down with a bad cold. No infusion until I am again 100 percent well. We have had some strange weather and everyone seems to be getting a touch of the flu. I am resting taking vitamins and drinking lots of fluids.
    Lauren your notes are very uplifting. I was diagnose in April of 2008. Thanks!

     

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