Living With MS

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

Friday, April 27, 2007

My Tysabri Diary...the tag above was created by a friend of mine who had MS (today would have been her birthday-she was such a nut-lol, and I miss her, but she is no longer suffering and this eases my loss.)

First, thank you ALL for your comments here (I've tried to respond to as many as I could in the comment section of my Blog), and a special thank you to those that left a comment to that creep on the "cafe pharma" site...makes me wonder what rock that A-hole (sorry) crawled out from under......geeeeeeeeez louise!

On a happier note (happier to me anyway)...
Here is an excellent Article (Findings) regarding Permanent Damage caused in MS, and my comments left re: early Tysabri therapy as a first line defense...

It's a long read but well worth it as the conclusions reached were EARLY treatment is needed to try and prevent the lesions (including "silent lesions") from causing permanent damage... here's the published Findings/Article:

Nerve Fibers are Severed by Inflammation in MS Lesions, Leading to Permanent Disabilities

My comments left: A very well written article. Of particular interest to me were the following conclusions: "..damage from lesions that are “clinically silent” (that is, those that don’t cause obvious symptoms), from lesions in the gray matter of the brain, and from the cumulative loss of axons (Figure 2) all underlie the permanent disability that most people with MS eventually experience."

"..Damage from clinically silent lesions is significant. Magnetic resonance imaging (MRI) has been extremely useful in extending researchers’ understanding of MS. MRI scans show that there are many more lesions in the nervous system of many people with MS than might be expected from their disabilities. This seems to be because most lesions occur in parts of the nervous system that are not immediately responsible for some sort of behavioral output, like walking or speaking, or for sensory perception. Therefore, even during the “remitting” phases of RRMS, there is generally ongoing damage from MS in these clinically silent lesions. Therefore, damage to the nervous system can be much more extensive than would be guessed by looking at a patient’s symptoms alone".

"..The studies described here support the idea that anti-inflammatory treatment of MS should begin as early in the course of the disease as possible. By extension, suspected MS should be verified as quickly as possible, because many patients have silent lesions for years before their first acute neurological episode, and it is important to minimize this early damage. Likewise, treatment should be continued between relapses, to prevent or minimize damage from clinically silent lesions".

As a patient with MS for 31+years, only re-classified as SPMS with relapses in mid-2005, I am now gratefully and thankfully on Tysabri(Natalizumab) therapy as I have not had one relapse nor disease progression since 10/06 (re-started Tysabri at that time when it became available again). I believe your article further supports the use of Tysabri's superior efficacy of 67% as a first line defense against MS, which is needed in EARLY treatment of MS, as it's Label 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."
Thank you for a wonderfully written article. Lauren Roberts

(((hugs))) to all of you reading my Blog :)
Love, Lauren
A very proud member of

Monday, April 23, 2007

Tysabri's GOOD name was just SMEARED by FALSE reports of PML...see the thread located at:

Pay close attention to the insightful and well-reasoned response (post #2 - I don't know who that was, but KUDOS to them!) immediately following the original #1 post by the jerk that posted the false PML information .... please note the smug and sarcastic reply in post #3 - the same idiot A$$**** WHO IS OBVIOUSLY one of Tysabri's competitors.

Remember, any suspected cases of PML must first be reported by the patient's treating physican to Biogen, who is required to investigate it further in order to confirm or deny same. If confirmed, they will notify the FDA via the FDA's Med-Watch site.......,


UGH! These friggin idiots need to be strung up by their ***** (private parts) and suffer the same agony they are falsely instilling in innocent MS patients.

A very proud member of

Saturday, April 21, 2007

My Tysabri Diary...Woo hoo hoo ..... Whoa! PPP...

Prescribing Instuctions on the Tysabri Patient Medication Guide which is Online and given to each patient when filling out the Tysabri Enrollment Forms!

Oops, sorry Kaiser - you lose, Again, : (page 16)


Only prescribers registered in the TOUCH™ Prescribing Program may prescribe TYSABRI® (see BOXED WARNING).
The recommended dose of TYSABRI® is 300 mg IV infusion every four weeks.

I left a message for my neuro Thurs. that I was looking directly at the dosing instructions on the PI-G and they are clear - every four weeks and the infusion center refuses to schedule my appts. every 28 days per the dosing instructions because their dr orders state every 30 days per Kaiser Corporate refusing to budge.

Well, guess what? The Kaiser Infusion Center called me at 4:15 today, Sat., changing my 5/18 appt to 5/16 inicating they rec'd new faxed dr's orders from my neuro for Tysabri infusions every 28 days...Knowing my neuro, she probably went directly to her boss (The Chief of Neurology) and got him involved with Corporate pdq!

So far:
Lauren - 6
SC Kaiser - 0

Take care all,

Love, Lauren <---smiling
A very
proud member of

Thursday, April 19, 2007

My Tysabri Diary...

I had my 7th Tysabri infusion yesterday, and right now, right at this moment, I feel terrific! Woooohooooo! My exhuberance is a bit tempered though as I am receiving a small handful of emails from Tysabri MS patients that are not achieving/feeling the same results of symptom improvement(s) as others have, and are becoming this post is for them, and for "newbies" to both MS and Tysabri:

For the disheartened....please try to remember three things - 1) The current level of your MS and disability did not happen overnight, therefore you must learn patience in your Tysabri treatments (attitude is everything when fighting your MS); 2) Tysabri is not a cure for MS or for your symptoms (especially if those disabilities are permanent); and most importantly - 3) If your disease has not progressed and you have no new symptoms since starting Tysabri, it's apparently working for you! Tysabri's label states: "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."

Which is why I firmly believe (in my humble opinion) that Tysabri intervention is needed EARLY - at the first onset of MS (so that the damage does not become permanent).

Am I still w/c bound since re-starting Tysabri 7 months ago??? Yes (I have been w/c bound for 16 months +, since 6/5/05 - is it permanent? I honestly don't know, but my attitude remains positive and hopeful that with the help of Tysabri and my physical therapy exercises that
I still do 3 x's a day, I will walk again someday - albeit kinda funny looking - lol )...,

Are both my hands still numb? Yes (And they have been since my dx back in 1976 (so the damage is probably permanent -
but my attitude remains positive and hopeful that with the help of Tysabri, I'll gain back some of the coordination and dexterity that I still had in them prior to 6/5/05 );

Is my balance still bad? Yes (But it's highly improved for approx. 3 weeks after my infusion, and
my attitude remains positive and hopeful that with the help of Tysabri, I'll completely gain back my balance one day );

Are both my feet still numb? Yes (But I can still curl my toes on both feet and move them from side to side a little bit
for approx. 3 weeks after my infusion, and my attitude remains positive and hopeful that with the help of Tysabri, I'll be able to lift my feet more than 1" one day );

Is my optic neuritis better in my right eye? Hell yeah
...for approx. 2 weeks after my infusion, I can't see the TV with my glasses on and have to take them off to see the TV clearly, but alas, I need them again going into the 3rd week after my infusion - I think part of this is due to 2 other factors - all the steroid damage I've had over the years, and age (I think I need bifocals now - ARG! )

Is my memory better? You betcha, and it remains so for approx. 3 weeks after my infusion.
( Wait, what were we just talking about?

Is my slurred speech better? Yeth, and it has remained so. ( Was that a lisp I just heard?

Are my bladder issues better? Yes, vast improvement, and it has also remained so

Is my energy level better? Yes, definitely, for approx. 3 weeks after my infusion

Is my Quality of Life better? Abso-friggin-lutely!
Without Tysabri, I was rapidly approaching SPMS without relapses and becoming bedridden...helpless and hopeless, and ineligible for Tysabri.

With Tysabri, for me, HOPE SPRINGS ETERNAL that my body still has a fighting chance to regain or even partially regain what has been lost to MS, that my body still has a fighting chance to heal or even partially heal itself from the temporary damage of MS, at the very least - maintain my disability level and not get worse, and best of all, when I start to feel my small improvements
(for now-heehee) fading away about 3 weeks after my infusion, I can tell myself: "Lauren, hold on..only one more week...soon you will get back to where you were 3 weeks ago, and there might even be a surprise waiting for you (a new improvement!)"...,

Tysabri = Hope? For me, oooooooh yeeeeeeah!

Now, for those unfamiliar to Tysabri and/or MS, first let me say that the following is not medical advice regarding either Tysabri or MS. These are only my experiences and layperson's opinions after having MS for 31 years, and from having 7 infusions of Tysabri since 10/16/06.

Tysabri works differently than the older generation MS medications (the ABCRs), as Tysabri is specifically designed as a Selective Adhesion Molecule (S.A.M.) that attaches itself to the T-cells (inflammation cells) that attempt to cross the Blood Brain Barrier (BBB) and enter the Central Nervous System (CNS) which is comprised of our brain, optic nerves, and spine.

This is when the T-cells see our myelin (the protective coating for our nerves) as foreign, and starts to attack it, leaving scarring (sclerosis) that shows up most of the time on a MRI as white/grey spots, which eventually leads to axonal loss (i.e., damage resulting in disability). It is also explained as a misfiring of nerve signals to the receiving nerves (which can result in such symptoms as numbness, tingling, weakness, temp. or permanent optic neuritis, fatigue, bladder problems, balance problems, and even paralysis sometimes, etc.)

Generally speaking, if lesions/spots are showing on MRI and lit up like lightbulbs, that usually means the disease process/lesion/relapse is active.

Further, even if a person still feels great while not on a Disease Modifying Drug (DMD), they can still have "silent lesions" forming with no resulting disabilities at that time...unfortunately, due to the nature of MS being a chronic and progressive disease, the resulting disabilities usually show up later, and by then, the resulting damage might be permanent. This is why most neurologists want the patient to start on one of the various DMDs, as soon as possible.

Tysabri's mechanism of action against MS: When Tysabri attaches itself to the damaging T-cells, it prevents a majority of them from crossing the BBB and entering the CNS. And even if a few do get across the BBB and enter the CNS, Tysabri is able to migrate (move) them away from our myelin, providing us with double coverage from those pesky, damaging T-cells.

This accounts for part of the fantastic studies recently reported re: Natalizumab (Tysabri) and it affect on Optic Neuritis

Tysabri basically stops/slows the cascading effects of the continuous onslaught of damaging T-cells from attacking our myelin, which in turn, gives our body an opportunity to try and heal itself (providing the damage is not permanent).

Regarding various mis-information circulating all over the web about Tysabri, please note: Pursuant to the approved FDA labeling, Tysabri is for patients with relapsing forms of MS that generally have not responded to, or cannot tolerate, other MS treatments. What this means is that Tysabri is a first line (like the ABCRs) AND/OR a second line defense/treatment for MS.

The phrase "cannot tolerate" can be interpreted by the treating physican to include their "needle-phobic" patients...or patients with "aggressive forms of relapsing MS"... , therefore, the patient does NOT necessarily have to fail one med first in order to have Tysabri. Pursuant to Dr. Katz and Dr. Temple of the FDA, they explained to the public in a Conference Call shortly after their Advisory Committee hearings in March, 2006 that the FDA's decision/language above was purposely left open and left up to the treating physican (as it should be, in my humble opinion).

With regard to Tysabri and the use of steroids to treat a relapse: According to the TOUCH protocol, the patient CAN have SHORT courses of steroids (IVSM or Prednisone), to treat a relapse/flare-up while on Tysabri (see the NMSS website for verification and further clarification). Again, these decisions should be left up to the patient's treating physican, as the FDA intended.

Lastly, regarding PML: The experts and authors of the world renowned New England Journal of Medicine attributes PML to diminished immunosurveillance (or a very low immune system), and
not to Tysabri.

Additionally, think about this for just a minute: there were 3 trial patients that developed PML: 2 of which were given Tysabri
in combination with Avonex (which is another immunomodulator), and 1 Crohn's patient that had a previous severely compromised immune system due to being on Azathioprine for 6 years. Of these 3 patients - 2 died, and neither of them had MS.

This means that out of approx. 3,000 trial patients that had a confirmed dx of MS and Crohn's disease, that did not have a compromised immune system, and received Tysabri as a monotherapy (by itself), and the approx. 5,000 general population patients that also met the above criteria (me included) from 11/04 to 2/05, that's 8,000 patients total,
plus the additional approx. 8,000 patients that have received Tysabri since it's relaunch in 2006 (with the same above criteria) - that's a grand total of 16,000 patients - get this: not one of us developed PML and died - which is a risk factor of ZERO in 16,000 or 0:16,000.

Each patient should discuss Tysabri with their treating physican, and weigh the minimal 0.1% risk of PML vs. it's enormous benefits of superior efficacy of 67%.

The above is not meant to scare anyone (because we are all different and there's no "one size fits all" explanation for a complicated disease like MS, nor a complex medication like Tysabri)- it's only meant to pass on my experiences with Tysabri and MS, and to try and help educate others in their disease...again, the above is not to be construed as medical advice by any's only my (layperson's) attempt to briefly and very simply explain Tysabri's mechanism of action against MS.

Remember dearhearts, Knowledge Is Power - MS symptoms are like snowflakes...all uniquely different for each of us - and yet - all similarly the same.

What we choose to do with the information we learn about our disease and its available therapies can make the difference between a lifetime of pain, suffering, disabilities, fear and confusion - or a lifetime filled with hope, possibilities, and a better Quality of Life.

It's our choice.

((((((((hugs to all))))))))

With much Love,


A very proud member of

Saturday, April 14, 2007

My Tysabri Diary...

Another young lady named Shannon posted a comment on my Blog....hey Shannon~! I posted a comment on your Blog "", under Tysabri or not Tysabri, but I don't see it there.

Dearheart, there is no need to be terrified of Tysabri, honest...I'll tell you the same thing I told another young lady named Brooke, that also previously left me a comment that she was also scared of Tysabri,
which by the way, she isn't anymore! :)

Shannon, please write to me and give me your email address so that I can correspond with you and try to calm your fears, okay? My email address is LGLBGL2003@AOL.COM.

If you feel uncomfortable writing to me, I'll try to help you here:

1. First, take a couple of deep breaths and calm yourself down, there is no need to panic and no need to be terrified, stressing like this might lead to a relapse, and none of us want that, right? Right! :)

2. I'm not worried in the least about PML. Experts believe it's caused by a dimished (very low) immune system...and I'm not on any other strong immune suppressants or immunomodulators (like the ABCR's), which could lower my immune system and cause PML. I'm just on Tysabri...Furthermore, MS patients in general have a very strong and highly active immune system to begin with - which is why we keep having relapses! ;)

3. If
you're still terrified of PML (Progressive Multifocal Leukoencephalopathy), think about this for just a minute: there were 3 trial patients that developed PML: 2 pts. when using Tysabri in combination with Avonex (another immunomodulator), and 1 Crohn's pt that had a previous severely compromised immune system due to being on Azathoprine for 6 years. Of these 3 pts, 2 died, and neither of them had MS.

This means that out of approx. 3,000 trial pts that had a confirmed dx of MS, that did not have a compomised immune system, and received Tysabri as a monotherapy (by itself), and the approx. 5,000 general population pts that also met the above critera (me included) from 11/04 to 2/05, that's 8,000 pts. total, plus the additional approx. 6,300 patients that have received Tysabri since it's relaunch in 2006 (with the same above criteria) - that's a grand total of 14,300 patients - and get this: not one of us developed PML and died - which is a risk factor of
zero in 14,300 or 0:14,300!

So please don't be afraid of Tysabri - discuss it fully with your neurologist that is knowledgeable about Tysabri.

Dearheart, you are close to the same age I was when I was first dx'd with MS (I was 22 then - I am now 52 (yikes!), so you are young enough to be my daughter or my little sister. And if this were the case, I would sit you down (just like I did with Brooke and too many others to mention), wrap my arms around you and give you the biggest hug you ever had - and look right into your eyes and tell you firmly but gently the God's honest truth, "It is going to be okay - you have nothing to fear but fear itself - and you are not alone."

And that goes for all of you out there too! ... Let not your heart be troubled.

Love, Lauren
A very proud member of

Saturday, April 07, 2007

My Tysabri Diary...

Happy Easter Everyone! I pray you all have a blessed holiday tomorrow :)

I just crack up everytime I see the above photo of the two chocolate bunnies, so I thought I'd share a smile before I posted important Tysabri information.

As some of you may or may not know, NICE (National Institute for Health and Clinical Excellence) is an organization in the UK that recommends or does not recommend drugs be paid for by England's and Wales' NHS (National Health System)...and it is much like our FDA Advisory Committees.

Unfortunately, they had rejected Tysabri (Natalizumab) in 2006, and their preliminary analysis in 2007 of new data submitted by the sponsors of Tysabri (Biogen & Elan) still has not been able to convinced them to recommend Tysabri to the NHS.

This is extremely worrisome as the UK has only been reviewing and rejecting Tysabri for highly active relapsing-remitting MS (which usually strikes young adults in their prime). The MS'ers in the UK need our help in convincing NICE to recommend Tysabri to their NHS so their MS patients can receive Tysabri (the best and superior in efficacy of 68%) MS therapy available to date to help them fight their MS, and have it paid for by the NHS. Without same, they will basically be condemend to a lifetime of suffering debilitating and accumulating relapses and resulting disabilities, combined with disease progression.

Apparently, cost-effectiveness (according to NICE) is more important than their MS'ers Quality of Life - I still can't figure out how they can put a price on suffering MS patient's Quality of Life and basically state that they aren't worth it...bottom line, we are ALL worth it!

If you agree with me, please become involved and speak out/be a patient advocate for the UK's MS patients and fight with me in attempting to convince NICE that they need to RECOMMEND TYSABRI TO THEIR NHS BEFORE the cutoff date of APRIL 23, 2007, as their final decision will be published in July, 2007. Should they recommend against Tysabri once again, they won't even consider looking at Tysabri (Natalizumab) again until 2010!

Here is their website to submit your comments (Appraisal Consultation Document):

(Note: be sure to copy your comments into an email or a document on your computer first, because once you submit them in the one box provided, the website then takes you back to the beginning of their page again, but at that time, it gives you separate boxes to enter your arguments in-and then you can just copy and paste your arguments into the separate boxes where appropriate - typical bureaucrats - ugh)....,

Here are my arguments/comments sent that are shown below in their combined form. I later broke them down by copying and pasting same into the various boxes provided:

"Reconsideration is desperately needed of NICE's decision not to recommend Natalizumab (hereinafter referred to as Tysabri) for Multiple Sclerosis patients. To effectively assess the advantages or disadvantages of Tysabri, or any disease modifying drug treatment, NICE needs to significantly recognize that once disability has set in, treatment is too late and for the person with MS, the clock cannot be turned back.

Over the last decade, research shows emphatically that MS needs to be treated from the start to prevent permanent disability and slow the disease process down (which usually strikes young adults in their prime). Advantages of Natalizumab (Tysabri): Natalizumab is a welcome advance in the treatment of multiple sclerosis in that it 1) reduces disease progression; 2) reduces number & severity of relapses; 3) reduces use of costly & damaging steroids; 4) reduces costly hospital admissions; and 5) improves quality of life & reduces cognitive decline.

Tysabri has been shown to reduce the annual rate of relapses by 68%, and after one year, 77% of patients on treatment were relapse free as compared to 56% in the placebo group. Tysabri has sustained effect on the annual relapse rate in MS patients treated for up to
three years.

The approximate cost per relapse avoided with Tysabri was between $13,000 (USD) & $24,000 (USD) lower than that of the other disease-modifying therapies (the ABCR's). A reduction of the number of relapses will enable the person with MS to stay working, pay taxes, have a more meaningful family & social life.

Tysabri offers an important therapeutic option for many patients living with the debilitating effects of MS. It is impossible to over-estimate the impact of a long-term condition such as MS (which is huge), just as it is impossible to under-estimate the positive impact of early treatment with Tysabri early in the disease course.

Persons with MS have a much higher level of depression and suicide than the general population. Lack of work (due to the increasing disabilities of MS) and lack of effective management of their condition is a major contributor to the suicide risk. The enormous benefits of Tysabri far outweigh it's minimal .1% risk of PML, and MS patients, such as myself, are willing to take such a minimal risk in order to stop/slow our disease progression, and reduce our relapse rate with further accumulating disabilities. Additionally, the risks of Mitoxantrone (Novantrone) carries a 1:200 risk of permanent cardiac damage and a 1:400 risk of promyelocytic leukaemia. This compares with the minimal 1:1000 risk of PML with Tysabri.

When comparing relapse reduction rates (Tysabri-67%; Avonex (Interferon beta-1a IM) 32%; Betaseron(R) (Interferon beta-1b) 34%; Copaxone(R) (glatiramer acetate) 29%; and Rebif(R) (Interferon beta-1a SC) 32%),
it is clear that Tysabri is needed in the UK to treat it's MS patients in a cost-effective manner.

Another advantage to Tysabri is that it is administered via an IV infusion every 28 days and this is another positive for persons with MS. It is not only convenient, it ensures that they will be monitored while having their monthly treatment, and it will further ensure compliance that the patient stay on their MS therapy, while removing any fear of self-injection as required for the current disease modifying drug therapies, and non-compliance with same due to their horrific side effects and injection site reactions. Tysabri is well tolerated, easy to administer, and adherence/compliance will be high among patients if approved by the NHS.

To not have Tysabri available by the NHS would leave persons with MS, who have highly active relapsing disease, only hopelessness and dispair, further debilitating relapses with accumulating disabilities, and a rapid decline in their health and well-being, with increased suffering.

Failure of the NHS to authorize Tysabri will result in untreated highly active relapsing-remitting MS leading to repeated hospital admissions for eventual ineffective steroid treatments and increased costs to be borne by the NHS, and an ultimate showing of a wanton disregard for the complete destruction of a suffering patient's life.

Finally, give the MS patient hope and a fighting chance to live a fulfilling life and substantially contribute to society. Do the right thing, recommend Tysabri (Natalizumab) to the NHS for the treatment of highly active relapsing-remitting forms of Multiple Sclerosis.

Respectfully submitted,
Lauren Roberts
(MS patient for 31 years & current Tysabri patient) "

Thank you for helping our UK MS bretheren, and thank you to each person that has left a comment on my Blog recently.Please enjoy your holiday tomorrow everyone, enjoy your loved ones while they are still around, including your friends....Be Blessed!

Love, Lauren
A very proud member of

PS: I had my 6 month checkup with my neurologist, and she was surprised and delighted at the strength I have gained while on Tysabri! She wrote orders for another 6 months of Tysabri for me...Wooohooo!