Living With MS

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

Monday, July 23, 2007

My Tysabri Diary...Happy Birthday Tysabri! WoooooHooooo!

Tysabri Celebrates One-Year Anniversary -

TYSABRI(R) Celebrates One-Year Anniversary as a Treatment for Multiple Sclerosis

Jul 23 2007, 2:30 AM EST

Business Wire

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced today the one-year anniversary of TYSABRI(R) (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). One year following its return to market in the US and introduction in the European Union, the companies estimate that as of mid-July 2007 in both commercial use and clinical trials approximately 14,000 patients are currently on TYSABRI therapy worldwide.

As of mid-July 2007:

-- In the US, over 8,600 patients are on TYSABRI commercially and over 1,800 physicians have prescribed the therapy;

-- In the EU, over 4,300 patients are on TYSABRI therapy commercially; and

-- In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.

"Over the past year I have seen my patients benefit greatly from TYSABRI. As expected from clinical trials, TYSABRI is having a positive impact on their lives. The compelling efficacy of TYSABRI offers MS patients hope in the management of their disease," said Dr. Howard Rossman, Medical Director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Michigan, and Clinical Professor of Neurology at Michigan State University. "Increased experience with TYSABRI will continue to inform us and contribute to our understanding of the important role of this therapy for people living with MS."

"TYSABRI has had an incredible effect, and the improvements I have experienced are very real. I understand there are important risks to this therapy, but the benefits of TYSABRI were far too important for my family and me to overlook," said TYSABRI patient, Mike Lynch.

In July 2006, TYSABRI was reintroduced in the US under the TOUCH Prescribing Program, a restricted distribution program, and was also introduced in the EU under a risk management plan. These programs were developed due to the increased risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.


TYSABRI is a treatment approved for relapsing forms of MS in the US and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001)>

TYSABRI increases the risk of PML. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.

TYSABRI is approved in the United States, European Union, Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.

Love, Lauren :)
A very proud member of

Wednesday, July 11, 2007

My Tysabri Diary...I just got home from my 10th Tysabri infusion, Yeeeeeeehaaaaaaaaw!

WOW...STILL no side effects, YaaaaaY!
Usually I feel a little tired after my infusion but I don't think it's the infusion itself... it's usually the long drive (53 miles one way in rush-hour traffic) that wears me out and I feel the need to take a nap afterwards... this time though, WOWZERS... I'm SOOOO ready to go...(whistling "Take Me Out To The Ballgame" - heehee).

hope that I feel before and after each infusion is absolutely incredible... I wish each of you could feel what I'm feeling right now. If any of you who know me thought I was positive before - WELLLLLLL......LOOK OUT WORLD, HERE I COME!

Gosh I can hardly wait until tomorrow, to see what the new day brings...and considering the weather out here has been in the triple digits all last week (which left me feeling like a wet noodle), for me to anticipate a new day with this triple digit heatwave we're in... that's really saying something! And my Tysabri vial, has a new lot # and new expiration date...whoa!

Oh, and I even got my appetite back...Chinese food tonight - chicken chow mein, fried rice, eggrolls with a sweet and sour sauce, fortune cookies, and for dessert - Black Forest chocolate ice cream with brownie bits and cherries mixed in - YUM! (good Lord, I sound like I'm on steroids, LOL!)

Okay, Ray (my caregiver) is yelling "Dinner is ready"..., so I've got to go..., Have a great evening everybody! Take care,

Love, Lauren :)
A very proud member of

Sunday, July 08, 2007

My Tysabri Diary...Patient Advocacy

Many of you might be wondering why I am posting a blog entry like this ... well, I was visiting a MS blog where a young girl was spouting false information regarding Tysabri. So when I attempted to nicely enlightened her, she copped a major attitude with me and it became clear that her intentions were to seek sympathy and cause confusion among the other MS patients. Well that didn't sit to well with me, and I pretty much blasted her in a private message, so as not to embarrass her further in public (as she was doing a pretty good job of embarrassing herself due to her ignorance) - LOL

As a MS patient for over 31 years, current Tysabri patient, and active member of the MS community that encourages patients to be their own advocates, anyone reading my blog should be aware that I am only one of many who are extremely tired of Tysabri being unfairly maligned by these largely avoidable drug interactions; Tysabri's RiskMap/TOUCH protocol mitigates the 0.1% risk almost completely. And we do understand that no drug is without risk, not even aspirin.

Furthermore, we are aware of the very significant fact that Tysabri alone quite clearly did NOT present any extraordinary risk. It was the combination of Tysabri and other immune modulators and other immunosuppressant drugs that created the risk that caused Tysabri to be voluntarily withdrawn from the market for 15 months.

MS patients become disabled to the point that they cannot work and/or experience a very poor quality of life due to increasing and accumulating disabilities. Our patient population also has a very high suicide rate due to no hope left for many to hold on to, despite family and professional support.

Having Tysabri unfairly labeled
as a risky or "killer" drug by many in the media, and by arrogant, ignorant patients and professionals, discourages many naive patients and neurologists from fully considering Tysabri's use, which in turn deprives those patients and their families from its benefits that could accrue if the true and full facts were represented.

A large majority of MS patients are quite well-versed in Tysabri, and they view false media reports and false/ignorant patient information as biased and nothing more than "throwing the baby out with the bathwater."

Whether or not you are a Tysabri proponent for it's use a DMD therapy for treating Multiple Sclerosis, one must realize that false information only leads to uninformed MS patients suffering new and further (and quite possibly permanent) disabilities, many of which could have clearly been avoided with Tysabri's superior efficacy of 67%.

It's our treatment choice, and it's your choice as well to state the true and accurate facts regarding Tysabri.

Love, Lauren
A very proud member of

Tuesday, July 03, 2007

My Tysabri Diary...Yes, Yes, Yes!

 Oh yeah!!! NICE (The National Institute for Health and Clinical Excellence) reversed itself and is allowing Tysabri for HARRMS (Highly Active Relapsing Remitting MS) which apparently covers about 3,000-7,000 MS patients in the UK (as has been reported).... Tysabri is the only DMD approved by NICE to be recommended for reimbursement by the NHS - wooohooo!

The RES group (rapidly evolving severe RRMS) falls into this category defined as:

1) patients with two or more disabling relapses in 1 year, and with one or more gadolinium-enhancing lesions or a significant increase in T2 lesion load on brain magnetic resonance imaging [MRI] compared with a previous MRI.

•**apparently this does not include the sub-optimal group which are defined as patients with high disease activity (defined as at least one relapse in the previous year while on therapy and either at least nine T2-hyperintense lesions or at least one gadolinium-enhancing lesion on brain MRI), despite treatment with an interferon beta (IFN-beta) drug (sub-optimal therapy).

I guess that NICE feels the sub-optimal group needs to continue treatment with interferon first, and the interferons aren't even reimburseable under the NHS...go figure.

This is my opinion only: So if the sub-optimal group is not covered, it is not a stretch to see a patient from this group becoming an RES group patient - either through:

a) by qualification, as "1 relapse in previous year" is not too far from "2 or more relapses in previous year"

b) by the doctor's diagnosis of what the patient is saying (think about it).

Where there's a will there's a way, and where there's a need there is a will! ;)

Congratulations to our UK MS friends in England and Wales! I [we] sure hope that you can benefit from the superior efficacy of Tysabri, and that you enjoy a better Quality of Life!

Easier article to understand: TYSABRI(R) Recommended by NICE for Use in Highly Active Relapsing Remitting Multiple Sclerosis in the Final Appraisal Determination

Here is a quote from one of England's Professors/doctors: "This decision offers people with highly active relapsing remitting multiple sclerosis hope of regaining control of their disease," commented Professor Gavin Giovannoni, The Royal London Hospital. "TYSABRI represents a significant advance in MS treatment, offering real hope of delaying the progression of disability and reducing the frequency of relapses."

So I wonder, with this new positive reversal of NICE's original negative decision, will it impact the SMC's (Scot's) previous denial which is coming up for review in August 2007??? And will it also affect Australia's approval under their PBS coming up around November 2007???

I just truly believe there is hope in Tysabri for suffering MS patients all around the world! Wooohooohooo!


Love, Lauren :D

A very proud member of