My Tysabri Diary...

I received this comment left on my Blog:

At 2:04 PM, Brooke has MS said…

Hi lauren,
My name is Brooke and I am 22 I was dx almost 3 years ago and I have already taken Rebif(which caused bad dreams) Copaxone(I thought was great but a MRI showed different) I am getting my second infusion of Tysabri April 2nd. i am not noticing a huge difference....Except i am so tired...I dont know if it is the Timechange or the weather getting hotter but I havent noticed alot of difference. I am wondering if you are still very happy with Tysabri? Do you worry about PML? Sorry if you dont want to answer that. But I am really scared!

Brooke, dearheart....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 scared, stressing like this might lead to a relapse, and none of us want that, right? Right! :)

2. Give your body a chance for Tysabri to work.., and give Tysabri an opportunity to get a handle on your MS - in my opinion, it might take up to approximately 2-5 infusions to accomplish this - (from what you've stated above - and I'm not a dr. - it would seem to me that you have a very active and aggressive form of MS), but in my opinion, you are on the best and most superior MS med we have available to us to fight our MS (Tysabri). Remember honey - you did not develop all your MS symptoms in just 30 days, so you will more than likely need more than 30 days (i.e., just 1 Tysabri infusion every 4 weeks), before you notice any improvements. Also, remember patience is a virtue ;)

3. Being tired is one of the side effect of Tysabri - many Tysabri patients have reported this to me, but they also tell me it passes in time, and some say after their next infusion, they feel less fatigued or not tired at all! Besides, if that is a side effect of Tysabri - you know it's working... heck - I'll take a power nap to relieve the fatigue over having to deal with another relapse any day! :)

4. I am still EXTREMELY HAPPY with Tysabri! :D

5. Brooke, 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! ;)

Dearheart, you are the same age I was when I was first dx'd with MS - I am now 52 (eek!), so you are young enough to be my daughter or my little sister. And if this were the case, I would sit you down, 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! ... (Hmmm, This makes me wonder if I'm somehow earning the nickname of "Mother Tysabri" ? ... laughing at myself).

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

My Tysabri Diary...

I had my 6th dose of Tysabri last Wednesday - 3/21/07

It usually takes a couple of days after the infusion for me to feel it's full effects, and just 3 days later, I feel stronger already. My legs feel stronger and I have increased my p.t. repetitions by one for my legs (i.e., I am up to 10 stretching reps of the long leg tendon that runs down the back of the leg, behind the knee - per leg, 3x's a day, plus 10 leg presses from a sitting position in my w/c 3 x's a day) and I feel the constant urge to wiggle my toes, which I can still do on both feet.

Absolutely zero side effects, and with each infusion of Tysabri that I receive, I have renewed hope of walking once again and I will never give up that hope!

And ultimately, even if I never walk again, I won't be sad because I know Tysabri is working as it is performing (for me) exactly the way it was designed to do...from theTysabri Label: "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."

I am on the most superior and efficious MS treatment available to us in over a decade. For this reason, I can celebrate and be grateful that my Quality of Life has improved.

I still haven't had a relapse or any disease progression (that I can tell of anyway) since re-starting Tysabri in Oct. 06 - that's 6 months now - pretty amazing considering I was having a relapse with accumulating disabilities approximately once a month prior to my Tysabri therapy - Woooohooooo!!!

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

My Tysabri Diary...

Okay, be prepared to have your socks knocked off by the following video (more in a minute)...why post this on my Blog/My Tysabri Diary? Because, for me, this is how I feel about Tysabri...no matter what anyone says about MY choice of medicine to fight MY disease...I can hear Tysabri singing to MS patients everywhere - You're Gonna Love Me!!!

http://www.dailymotion.com/visited/video/x6sfz_amazing-11-year-old

Ready? Now, turn your speakers WAY up, settle back in your chair for 2+ minutes and give a listen to this ABSOLUTELY AMAZING 11 year old girl from the TV show "America's Got Talent", as she blows the roof off the auditorium singing "You're Gonna Love Me" ... the same song that recently won Jennifer Hudson an Oscar from 'Dreamgirls'.

It's inspiring, it's breath-taking, it's GREAT "feel good" entertainment for 2 minutes. This girl is only 11 ... she will be a future superstar ...there can be little doubt once you've heard her. This will make the hairs on your neck stand up, in a GOOD way. She shortens the song to fit the time limit she has to perform it, but WOWSERS!

Here are the full lyrics if you'd like to follow along. Enjoy!

AND I AM TELLING YOU I'M NOT GOING (YOU'RE GONNA LOVE ME)
By Jennifer Holliday (From "Dreamgirls")

And I am telling you
I'm not going.
You're the best man I'll ever know.
There's no way I can ever go,
No, no, no, no way,
No, no, no, no way I'm livin' without you.
I'm not livin' without you.
I don't want to be free.
I'm stayin',
I'm stayin',
And you, and you, you're gonna love me.
Ooh, you're gonna love me.

And I am telling you
I'm not going,
Even though the rough times are showing.
There's just no way,
There's no way.
We're part of the same place.
We're part of the same time.
We both share the same blood.
We both have the same mind.
And time and time we have so much to share,
No, no, no,
No, no, no,
I'm not wakin' up tomorrow mornin'
And findin' that there's nobody there.
Darling, there's no way,
No, no, no, no way I'm livin' without you.
I'm not livin' without you.
You see, there's just no way,
There's no way.

Tear down the mountains,
Yell, scream and shout.
You can say what you want,
I'm not walkin' out.
Stop all the rivers,
Push, strike, and kill.
I'm not gonna leave you,
There's no way I will.

And I am telling you
I'm not going.
You're the best man I'll ever know.
There's no way I can ever, ever go,
No, no, no, no way,
No, no, no, no way I'm livin' without you.
Oh, I'm not livin' without you,
I'm not livin' without you.
I don't wanna be free.
I'm stayin',
I'm stayin',
And you, and you,
You're gonna love me.
Oh, hey, you're gonna love me,
Yes, ah, ooh, ooh, love me,
Ooh, ooh, ooh, love me,
Love me,
Love me,
Love me,
Love me.
You're gonna love me.

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

My Tysabri Diary...

I was interviewed today via a phone call by a reporter for the Stanford Daily, which she hopes will publish her article by the end of this month, MS Awareness Month. (She will send me the link when it's available for viewing online). She was very nice and very empathetic to the mis-information surrounding Tysabri. I pray her article will help patients learn the truth about Tysabri, and dispell the falsehoods circulating by "journalists" that are scaring patients needlessly.

We talked about everything from my first experience with Tysabri back in early 2005, the results I achieved at that time, the devastation of MS patients at it's voluntary removal, the safety data collected over the next excrutiating 15 months, the FDA AC hearings, our website http://www.mspatientsforchoice.org/ in our initial fight for Tysabri's return, then evolving into providing accurate info re: Tysabri, the PML issue, diminshed immunosurveillance, the combo therapy, the RiskMap, the infusion process, how upsetting it is (for me) to read the falsehoods being circulated (she had read the J. Fauber article which is scaring patients), uninformed/scared drs, the results I'm having now (which are small in comparison to my 2005 ressults), and how I will never give up spreading the word that Tysabri Equals Hope for the majority of MS patients to achieve some recovery (if not all) from their symptoms, prevent further relapses and their accumulating disabilities, and stop/slow the disease progression down until a cure for MS is found (which includes websites updating MS meds to include accurate Tysabri info, educating scared MS patients, etc..) and ultimately helping patients become their own advocates with knowledge and support as this is about our bodies, our disease, our lives on the line and it should be our choice to make a fully informed decision re: choosing the most superior and efficious DMD in over a decade to help us fight our disease with the continuing hopes of achieving an improved QoL.

I'm sure I forgot some things, but I did my best to try and spread the truth about Tysabri, that Tysabri Equals Hope.

(((hugs)))
Love, Lauren
A very proud member of http://www2.blogger.com/www.MSpatientsforchoice.org

My Tysabri Diary...

Now HERE is patient advocacy at it's finest!

http://www.tcsdaily.com/article.aspx?id=030807A

Needed From the FDA: Not Perfection, Just Consistency

FDA regulators need to balance patients' access to therapies with ensuring the safety of drugs. The consequences of poor decisions can be grim: Promote access at the expense of safety, and a dangerous product can cause incalculable harm; over-emphasize safety at the expense of access, and patients suffer from the absence of life-saving, life-enhancing medications.

In recent decisions on the post-approval risk management of two drugs, Tysabri and Rituxan, FDA regulators have failed to be internally consistent - and thereby sowed confusion among patients, physicians and drugmakers.

In late 2004, Tysabri became only the sixth medication approved -- and the first in several years -- for the treatment of multiple sclerosis, a common and debilitating (and often heart-breaking) autoimmune disease that affects the central nervous system. The drug's testing in clinical trials yielded impressive results -- the frequency of clinical relapses reduced by more than half - and induced the FDA to grant accelerated approval.

In early 2005, however, with several thousand patients already being treated with Tysabri, it was discovered that three had contracted progressive multifocal leukoencephalopathy (PML), a rare and often fatal neurological disorder caused by a virus. (Because the drug suppresses certain components of the immune response, regulators, clinicians and the product's developers had from the beginning been sensitive to the possibility of infections as a side effect.) Immediately -- some would say prematurely -- the manufacturers voluntarily halted production and distribution and withdrew Tysabri from the market.

An uproar ensued. Self-appointed "safety watchdogs" cited Tysabri as yet another case of an allegedly harmful, inadequately tested product finding its way onto the market. Conversely, MS patients and neurologists were bitterly disappointed at being deprived of what for some was an almost miraculous therapy -- and of the ability to make their own informed decisions about options for treatment. After the analysis of new safety data, an FDA advisory committee recommended Tysabri's return to the market with revised labeling.

However, the FDA went far beyond modifying the labeling to contain more prominent warnings to reflect new knowledge of the drug's side effects (which would, in my view, have been sufficient) and insisted instead on a baroque risk management action plan (RiskMAP) that imposes onerous restrictions on the use of Tysabri. These include limited distribution and additional education and monitoring requirements for patients, prescribers, pharmacies and infusion centers.

RiskMAPs were originally conceived by the FDA as a fail-safe for the small number of products that offer unique benefits but also carry atypical and significant risks. Less intrusive elements of these plans might include special labeling and more intensive education about product use and precautions, but the FDA adopted far more obtrusive restrictions and requirements such as mandatory enrollment in patient registries, controlled distribution, and prescribed behavior (such as the use of two kinds of contraception in the case of one drug) by patients.

Other products subject to such regimes include Accutane, used to treat severe recalcitrant nodular acne; and Thalomid, for multiple myeloma and the cutaneous manifestations of leprosy. Like Tysabri, both drugs provide unique and significant benefits to their users that are not offered by other medications but have severe, rare side effects. Accutane and Thalomid are known potent teratogens - substances capable of interfering with the normal development of a fetus and causing birth defects or the loss of a pregnancy or other complications - and therefore must be avoided by women who are or who may become pregnant. But the exhaustive (and exhausting) list of requirements for physicians, pharmacists and patients makes one wonder whether the next FDA safety innovation will be a mandatory live-in nanny to monitor patients' compliance with the RiskMAP.

The RiskMAPs for all three drugs are excessively restrictive, seemingly more appropriate for weapons-grade plutonium than a pharmaceutical. Although health practitioners and patients certainly need complete and accurate information about a product's potential risks, regulators should enable patients and physicians to make informed decisions within an expanding universe of therapies, not create an obstacle course between the sick and their medications.

Patients, physicians, pharmacists and drugmakers conform to the RiskMAPs because they have no choice: The FDA is the only game in town, and playing along is the only way that all these stakeholders can variously receive, prescribe, dispense and manufacture the medications.

And that brings us to Rituxan, a treatment for rheumatoid arthritis and certain kinds of lymphomas. Like Tysabri, it acts by suppressing elements of the immune system and also has been linked to PML; there have been 23 confirmed cases of PML in patients receiving Rituxan for the approved indication of non-Hodgkin's lymphoma and, most recently, two in patients being treated experimentally for systemic lupus erythematosus ("lupus").

But unlike Tysabri, Rituxan has never been subject to a RiskMAP. And in spite of the new cases of PML in patients with lupus - and the fact that Rituxan also is under consideration for treatment of MS - the FDA was content merely to update the package insert for Rituxan.

Multiple sclerosis patients on Tysabri are right to feel discriminated against. While they and their healthcare providers must navigate a veritable RiskMAP maze to obtain and maintain access to their approved medication, patients taking Rituxan - which carries a similar risk of PML - need not.

I am not arguing here that Rituxan should be subject to a more restrictive RiskMAP or that Tysabri deserves a less restrictive one (although I favor the latter) -- merely that the FDA's inconsistency sends mixed signals and creates uncertainty, the bane of patients, physicians and drug companies alike. Are some medications more worthy of patient and physician discretion than others even if they carry the same risk? Are some patients more deserving than others of the right to make their own decisions about risk and benefit?

Even under ideal circumstances, the regulation of drugs involves complex risk-benefit calculations performed with incomplete and evolving data. We cannot expect perfection from our regulators, but we can demand sufficient consistency to make the process transparent to patients, health practitioners and drug developers.

Dr. Miller, a physician and a fellow at the Hoover Institution and Competitive Enterprise Institute, headed the FDA's Office of Biotechnology from 1989 to 1993. His most recent book is "The Frankenfood Myth."

Yaaaaaaaaaay Dr. Miller (he deserves a BIG Woooooohooooooo!)

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

My Tysabri Diary...

Happy Anniversary to the Comeback Kid - Tysabri! ...

Explanation of above photo: Tysabri is the kitty - the ferocious dogs are Tysabri's critics ;)

I have to laugh when I revisit those old media and financial analysist reports that said Tysabri won't ever come back, and needless to say, its back - and with a vengence now too - overtaking the ABCR's by leaps and bounds - in spite of being held back during it's "re-debut".

I've been posting all over some of the MS message boards today, rebutting J.Fauber's article, ending with the following in my posts:

"By the way, today is the 1 year anniversary of the FDA AC decision that unanimously voted to recommend Tysabri's return to suffering MS patients. Wooohooo!"


http://www.msrefugees.proboards82.com/index.cgi?board=tysabri&action=display&thread=1173204439


Is it hard to keep a good drug down? Ha!

Thank you to MSP4C, my friends and too many others to mention, for allowing me the opportunity to share my voice in our victory.

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

My Tysabri Diary...

As this week (March 5-12) is MS Awareness Week, I thought it was appropriate for all of you MS patients, and specifically Tysabri patients, to be aware of the falsehoods re: Tysabri are still being pumped by either Tysabri's competitors, ignorant reporters, or journalists who hook their readers with sensationalistic falshhoods rather than the truth.

This is what I just posted on a MS board in an effort to try and stop promoting these falsehoods (as this person posted this article on two separate forums of that board-ugh!)...won't you Tysabri users join me in writing Mr. Fauber?:

"I too posted the following in the News section as well:

Hello squeaky...

As this is MS Awareness Week, here was my reply to Mr. John Fauber, who wrote that article that was slanted, biased, and filled with falsehoods and misinformation, including the cost of Tysabri. I advised his editor of same as well, by submitting an op-ed piece....it is articles like his that are used to scare patients needlessly.

I would suggest all of us on Tysabri write him and speak their mind...I can't even count the number of emails I received from scared MS patients that I had to calm down and reassure due to OUTRAGEOUS articles like his that promote these misconceptions...UGH! All of us need to be Aware of cr*p like his article:

jfauber@journalsentinel.com

Mr. Farber,

I have reviewed your article "milwalkee journal sentinel, Multiple sclerosis drug brings lethal risks, but great promise for some" dated 3/7/07 http://www.jsonline.com/story/index.aspx?id=572826 .

As a MS sufferer for 31 years, I am quite dismayed at the false and misleading information that you have reported re: Tysabri, and which has now done a terrible disservice to the MS Community - specifically MS patients looking for accurate information on Tysabri. Further, I have had 5 Tysabri infusions since 10/06, plus one infusion in early 2005, prior to it's voluntary removal from the market so that additional safety reviews and data could be studied, collected, and submitted to the FDA for final analysis.

Please allow me to comment on a numerous falsehoods that were reported (I am also writing to your editor with a request for a published apology and correction to your readers):

1. "a precious but potentially lethal fluid into his vein." Tysabri is not and has never been lethal, nor has it ever been attributed to the death of a confirmed MS patient with a non-compromised immune system when administered as a monotherapy. Approximately 3ooo trial patients and approximately 5000 patients in the general population from 11/04 - 2/05 that met the critera above (myself included), for a total of 8,000 patients, none of us developed PML and died. That's a risk factor of zero in 8,000 or 0:8000.

Progressive Multifocal Leukoencephalopy (PML) has been attributed to dimished immunosurveillance and NOT Tysabri. See NEJM -- Medline Abstract re: PML"... the emergence of PML has been attributed to diminished immunosurveillance."

2. "As the drug, which costs several thousand dollars a month".. Tysabri does not cost several thousand dollars a month. Tysabri costs $2,184.62 per vial, and as an outpatient procedure/infusion, it is covered by Medicare/Medicaid and most insurance policies. http://www.elan.com/Products/united_states/tysabri_pricing.asp Elan: TYSABRI® Pricing and Financial Assistance.

3. "The drug was taken off the market in 2005 after three people out of about 2,900 who had been in clinical trials developed brain infections."...out of those 3 patients - 2* of them received Tysabri in combination with Avonex-an immunomodulator, and the third patient was a Crohn's patient with an existing severely compromised immune system due to being on Azathropine/Imuran for 6 years. *The "MS" patient that had the combination therapy with Avonex and died, upon autopsy revealed that she did not have histopathegic MS. And neither did the Crohn's patient that died. Therefore, your statement "Two of them died" needs to be quantified as the 2 patients that died did NOT have MS.

4. "There is no treatment for the infection, known as progressive multifocal leukoencephalopathy, or PML. And there is no way of knowing who will get it" - 75% to 80% of the general population (MS or not) carry the JC Virus which lies dormant in the kidneys. Experts believe that when the immune system is severely compromised, the JC Virus is released into the blood stream and develops into PML - and the CNF can confirm same if symptoms of PML develop, as well as diffused lesions on MRI. Therefore, a patient can't "get" PML like a cold, and Tysabri's strict TOUCH protocol is in place to minimize the risk of developing PML, and which can also identify those higher-risk patients..

5. "There is some indication that it may be twice as effective as other MS drugs and that it can reduce the number of relapses by two-thirds". There is proven data of these facts - see two separate findings: (1) TYSABRI® Two-Year Phase III Multiple Sclerosis Clinical Trial Results and Safety Evaluation Published in New England Journal of Medicine http://www.elan.com/News/full.asp?ID=824216; (2) New Pharmacoeconomic Data on TYSABRI® Demonstrate Significant Reduction in Steroid Use and Hospitalizations in Patients with Multiple Sclerosis http://www.elan.com/News/full.asp?ID=913012.

6. "Beyond the grim calculus of risk and reward". When the patient and their neurologist weigh the accurate and low risk vs. the superior efficacy of 68% and Tysabri's proven spectacular rewards, I would hardly categorize that as 'a grim calculus'. Further, see the Utah story of the gentleman previously in a w/c, and now is walking again with Tysabri: ksl.com - One Utahn with M.S. Experiencing a Miraculous Recovery http://www.ksl.com/?nid=148&sid=909753. [Darren posts on my Blog]

7. Your quote from a neurologist: ""You need to be very selective about who you treat."". From the Tysabri Label: "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." With over 400,000 MS patients in the U.S. alone that have a 'relapsing' form of MS (50% +), and with Tysabri's FDA approved use as a 1st line and/or 2nd line therapy, I would hardly call that 'very selective' either.

8. "For instance, a claim receipt from one Tysabri patient shows St. Luke'sbilled Humana Insurance $9,991, minus $3,996 for a plan discount,resulting in a net payment of $5,995. St. Luke's declined to comment onpricing.". Such price gouging is coming from the infusion centers - not from the drug price. Such unethical business practices should be immediately reported to the appropriate authorities of each state where this is taking place .

What a sad day it was when I read your article which is filled with so many false, misleading and biased statements (too many to address in one email). It was (I believe) designed to scare patients away from the most effective MS therapy available to them in over a decade, which could prevent them from suffering needless disabling relapses, further disease progression, or having to endure the horrific side effects and injection site reactions of the lesser effective older generation drugs. At least it certainly appeared that way from statements I'm hearing and seeing made from many others (with and without MS) .

If you want to research accurate facts re: Tysabri, go to http://www.mspatientsforchoice.org/ which has Tysabri Patient Progress Reports, Tysabri videotapes, and much, much more.

Mr. Fauber, you now have the perfect opportunity to right this egregious wrong, and show your readers what a truly outstanding journalist and paper can do for their community and more importantly, for those who are suffering worldwide from the debilitating effects of Multiple Sclerosis.

Thank you for time and for your attention to the above.

Respectfully submitted,
Lauren Roberts
A very proud member of:
http://www.MSPatientsForChoice.org "


I'm exhausted, and it's dinnertime here.....until next time -

(((hugs))) Love, Lauren

My Tysabri Diary...

Hi crippy, nice to make your acquaintance! Oh yes, I know all about RK Rowling's article lashing out at the SMC's (Scottish Medicine Consortium) rejection of Tysabri - I even posted a comment on the page of new's article that broke the story, wrote to the UK MS Trust website the day before the Scottish Parliament again heard debates Thursday, 3/1...as spearheaded by Ms. Trica Marwick-excellent too-here's where you can watch it (if it's still available), and in brief, here was what I sent them:

"Rowling hits out at NHS ban on costly MS treatment for Scots

http://story.100.com/?rid=7145354&cat=a1e025da3c02ca7c

Additionally, your viewers/readers might like to know that they can watch the Scottish Parliament debate live, Thursday, March 1st, at about Noon ET (9:00 am PT, and 7:00 am in Alaska and Hawaii) at http://www.holyrood.tv/popup.asp?stream=http://vr-sp-archive.lbwa.verio.net/archive/members_010307.wmv (Click on "Play Live stream" at the top of the page and/or then click "Launch in external player").

The Members of the Scottish Parliament will be debating S2M-5305, sponsored by MSP Tricia Marwick, on "Tysabri for People with MS.

"S2M-5305 Tricia Marwick: Tysabri for People with MS—That the Parliament deplores the decision by the Scottish Medicines Consortium not to recommend that Tysabri be prescribed to people with multiple sclerosis (MS); notes that, for a small number of those with the most aggressive from of relapsing-remitting MS for whom existing treatments do not work, Tysabri represents the only treatment available; notes that Tysabri is prescribed in Germany, Ireland and the United States of America but not in Scotland, which has the highest rate of MS in the world, and urges NHS boards in Scotland to allow the prescribing of Tysabri which had been described by Dr Gavin Giovannoni, of the National Hospital for Neurology and Neurosurgery in London, as the most significant advance in MS treatment for nearly a decade. Supported by: Christine Grahame, Ms Sandra White, Stewart Stevenson, Mr Kenny MacAskill, John Scott, Frances Curran, Carolyn Leckie, Richard Lochhead, Murray Tosh, Mr Stewart Maxwell, Mr Adam Ingram, Mike Pringle, Robin Harper, Brian Adam, Bruce Crawford, Fiona Hyslop, Alex Neil, Mr John Swinney, Eleanor Scott, John Swinburne, Mr Ted Brocklebank, Michael Matheson

There are two competing motions, which differ in various respects:

S2M-5306 Ms Rosemary Byrne: Quality of Life for MS sufferers—That the Parliament is concerned that the Scottish Medicines Consortium (SMC) has decided not to recommend the drug Tysabri as a treatment for multiple sclerosis, despite it being highly effective for certain patients, leading to a 60% to 70% reduction in relapses; notes that Tysabri is a licensed drug approved by the Medicines and Healthcare products Regulatory Agency (MHRA) and SMC only provides advice to NHS boards and their area drug and therapeutics committees across Scotland; notes also that health professionals are expected to take due account of this recommendation when exercising their clinical judgment but that this recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, and calls on all NHS boards to acknowledge that clinicians must be able to prescribe this treatment where they believe there is a clinical need, regardless of SMC advice to them. Supported by: Tommy Sheridan, John Scott, Mr Adam Ingram, Carolyn Leckie, Murray Tosh, Robin Harper, Eleanor Scott, John Swinburne, Mr David Davidson, Christine Grahame, Mr Ted Brocklebank, Michael Matheson

S2M-5307 John Scott: Support for Prescribing of Tysabri for MS Sufferers in Scotland—That the Parliament notes the decision of the Scottish Medicines Consortium (SMC) that Tysabri should not be prescribed on the NHS; further notes that Scotland has the highest proportion of sufferers from multiple sclerosis in the world, that the SMC accepts that the clinical case for the use of Tysabri was sound and that the recommendation not to prescribe it on the NHS was taken on purely financial grounds, and therefore urges that this decision by the SMC be overturned and that Tysabri be made available on the NHS. Supported by: Mrs Nanette Milne, Ms Rosemary Byrne, Tommy Sheridan, Mr Adam Ingram, Dave Petrie, Murray Tosh, Rosie Kane, Robin Harper, Carolyn Leckie, Phil Gallie, Derek Brownlee, Mr Jamie McGrigor, Alex Johnstone, Alex Neil, Eleanor Scott, John Swinburne, Margaret Mitchell, Mr David Davidson, Bruce Crawford, Ms Sandra White, Christine Grahame, Bill Aitken, Lord James Douglas-Hamilton, Patrick Harvie, Fiona Hyslop, Mr Ted Brocklebank, Michael Matheson

A a very distinguished patient advocate (D.K.) and member of the website http://www.MSPatientsForChoice.org/, on Monday (2/26), emailed all of the co-sponsors of the three motions, providing them with links to our website and more information on the benefits of Tysabri. Also emailed were every other member of the Parliament, urging them to support the availability of Tysabri in Scotland. All were provided with the recent article about the Salt Lake City MS patient who was able to get out of his wheelchair and shovel snow (http://www.ksl.com/?nid=148&sid=909753), (The gentleman in the video is Darren - who posts comments occasionally on my Blog - waiving wildly to Darren :) I left a comment on that story too-lol) as well links to the Tysabri patient progress reports posted on our website http://www.mspatientsforchoice.org/progress.htm. Various benefits of Tysabri in terms of cost savings were also brought to their attention, including reduced hospitalizations and improved quality of life (possibly permitting some patients to return to work and pay taxes).

MS patients around the world (and specifically those of us in the US) are hopeful that the support and publicity from JK Rowling will help push this to victory. It would set an excellent precedent for the pending decision by NICE for coverage of Tysabri in the rest of the UK.

Thank you for all you do for MS sufferers, and thank you for your attention to this matter. Very truly yours, Lauren Roberts (MS patient for 31 yrs. & current Tysabri user) A very proud member of: http://www.MSPatientsForChoice.org/"

Crippy, might I suggest you work closely with the UK MS Trust as they are very pro-Tysabri, and see if you can get in contact with Ms. Rowling to engage her support before N.I.C.E.'s ruling in the very near future, as well as rally British MS patient support for Tysabri. If nothing else, perhaps you can help convince N.I.C.E. to at least pay for Tysabri at the same rate it pays for Avonex, Rebif, Betaseron and Copaxone, and then British MS charities or other charities/individuals can help pick up the difference. Perhaps even some English employers can help subsidize the marginal additional cost of Tysabri to keep a valued employee?

One last thing crippy, do note dearheart, that you stated "(the national institute for clinical excellence) has refused funding in scotland", which is incorrect - the SMC refused funding for Tysabri in Scotland, not N.I.C.E......which has yet to rule for England and Wales.

Good luck in your fight-I'll be cheering you on from across the pond (as many of us will too!)

A special hug for my new "ding-bat" and awesome photographer friend, Gretchen - heehee.

And oh my gosh, I almost forgot - I posted a comment Thursday night on a young MS'ers Blog (Live Journal) that was terrified to start Tysabri http://community.livejournal.com/ms_support/294930.html and I received this reply from her yesterday!...Subject: Re: Tysabri Information OMG your comment has completely uplifted my spirits about this, thank you so much.It's one thing to learn all the facts,a nd then another to learn the facts that come from MS patients, and not just the med complanies. Overall I really want to try Tysabri, it's just the fear of PML that has made me nervous. But learning this info and being able to look into it much more has really helped. I'm at a stage where, there really isn't much else I can do, and so I feel better to take the leap with some more knowledge into what I'm really doing. thank you so much!♥ nessa

Sweet! I'm so happy she's no longer terribly afraid of Tysabri :) .... Can I get an "Amen" or a "Wooooohooooo" from the choir? LOL

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

My Tysabri Diary...

From a funny lady I met after my posting on Stuart's Tysabri Poll and posted with her permission:

Lauren - I am such a dingbat - I just figured that this e mail was from you - the Lauren with with amazing web page and blog! Hey my cognitive function seems to vary from moment to moment sometimes.

So, that being said - I just wanted to tell you what a great and informative blog you have I am very very impressed with it!

I'm just starting to get more involved with MS organizations, web groups etc....I was dx'd in 2000 accidentally - they were actually looking for brachial plexus damage from my mastectomies! I was an RN and every once in awhile wondered about some of my strange symptoms and wondered if they could be MS - but nurses tend to turn everything into a worst case scenario...

Looking back, I'd actually been having symptoms and relapses since my mid twenties but always wrote them off to one thing or another.

Anyhow...I have a question about the Tysabri - it seems that following each dose, for two - three days I am unbelievably crabby, irritable, and just feel mean and pissed off at the entire world..I swear I almost want to slug every one that even speaks to me....so I just hole up in my room and try to avoid folks...LOL

Have you heard of anyone else having this kind of thing happen? Maybe I'm just a nut case....

Anyway, I'm really glad to have found your site/blog etc and hope you are having a wonderful day!

Take care Lauren - you are amazing!

Gretchen

Hmmm, no I haven't Gretchen - maybe you are just a nut case (ducks gracefully at that dayum left hook - "hey... You work out?" lol)

Seriously though, this could just be your body adjusting to Tysabri - I'm not a dr. and you should discuss same with your treating physician - especially if you are arrested for assault and battery (ok, I'm laughing so hard, I need to take a pee break - Ill b.rb.) ....lol

Ahhhhhh, much better - you know I love ya, girl (what's not to love in a new friend you just made that keeps your bladder in check?). Laughter is the best medicine...(wink).

Okay, I'm gonna go watch a movie and lavish some extra love on my kitty before I wake up one morning and find out she sold my caregiver Ray on Ebay - oh, I made a rhyme - heehee.

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