My Tysabri Diary...

I'm feeling very happy, although philosophical, today (this is always a "dangerous" combination concerning me, when I combine the two-lol).

For the past year, I have been trying to reach a conclusion regarding the following: People often ask me why I am such a believer in Tysabri, others question me as to whether or not I work for the drug companies that provide Tysabri for us (laughing - which I don't), others ask me why I'm such a strong patient advocate (more like bullheaded/stubborn-I admit it), while others
comment on my attitude of hope even though I'm not receiving the dramatic results (yet) of symptom improvements from Tysabri that some other patients are.

I'm not sure a simple conclusion exists, so I'll just hypothesize outloud (lol) ..., but first, let me share this recent comment left on my Blog by a extraordinary lady (sweet, kind, caring, intelligent and encouraging are just a few of her qualities) that I have come to recognize and become acquainted with through her emails:

At 5:06 PM, Anonymous said…

I am so admiring of your positive attitude and your well-placed hope in the future. I made a comment some months ago, saying my daughter was to be considered for Tysabri after the birth of her baby in October. Her insurance was not approved until last week [yes, it took a while and some writing to our state's attorney general] and she now is scheduled to receive her first infusion on Friday! She is excited and nervous, but very much hoping to reap some benefits. She is not obviously disabled but had been having breakthrough attacks on Copaxone and also attacks while she was pregnant....a small percentage do, we have since been told. So, Lauren, we are hoping like you and paying attention to your wonderfully modeled attitude.

I wish you continued improvements [big ones and little] through the months. Many of us readers obviously pay attention to your words. Enjoy your mild weather and sunshine and think of us up in the snowbelt.

Deb

I am truly humbled by Deb's words, and absolutely delighted and shocked that others actually pay attention to my words (other than the jerks/creeps that reported mis-information to Biogen) from my Blog. Thank's so much Deb...you no doubt must be an inspiration to your daughter and one which she probably aspires to model herself after (smiling).

Okay, now on to my silly, philosophical conclusions (I guess this is entertaining for some of you viewers, eh? LOL)...,

1. People often ask me why I am such a believer in Tysabri...my conclusion: This is due to my firsthand experience with Tysabri (especially from the dramatic improvements I had on it in 2005 with just 1 infusion)...nothing in this world will ever change my opinion of Tysabri - ever, until a cure is found for MS (which probably won't happen in my lifetime, but for the younger MS patients, they won't have to suffer years of relapses and accululating disabilities with Tysabri now here to protect them until that cure is found);

2. Others question me as to whether or not I work for the drug companies that provide Tysabri for us...my conclusion: Nope - I don't (laughing again), but I understand why some might think that, and actually, I see their remark as a compliment...I have been researching and following Tysabri (formerly known as Antegren) since 2000, so I have accumulated quite a bit of knowledge (also from listening to the brillance of others) regarding its properties and mechanism of action with regard to MS, including the probable/possible use of Tysabri with other auto-immune diseases such as Crohn's, Rheumatoid Arhritis, Lupus, etc.

3. Others ask me why I'm such a strong patient advocate...my conclusion: This is MY body, MY disease, MY life, and therefore I must be MY OWN patient advocate (as we all should)...I am NOT content in having a doctor (or anyone for that matter), take over driving my car (managing my disease) while leaving me in the passenger seat - only along for the ride....NOPE - NO WAY, in my opinion - it is the other way around..., my doctor is MY partner in helping me manage MY disease by listening to me - offering his/her learned advice - my researching it, and making MY OWN decisions that ultimately give ME the opportunity to fight MY disease. He/she (they) are the passengers along for the ride of MY life. :)

4. And finally...Others comment on my attitude of hope,even though I'm not (yet) receiving the dramatic results of symptom improvements from Tysabri that some other patients are...my conclusion: I have always had hope and optimisim, even as a little girl. It's part of my makeup as I realized we have all been given the gifts of Faith, Hope and Love. What we choose to do with these gifts is a Personal decision that each of us must decide for ourselves. Personally speaking, I don't think I could have survived living with MS for 31 years without these gifts in my life, and looking back now, I'm grateful for the decision I made in embracing them instead of rejecting them.

Don't get me wrong...I'm not preaching here as I am not a religous person, but I am a spiritual one. I live my life by choosing to see the glass as half-full, not half-empty (much to my chagrin of realizing too late that my ex-husband of 26 years was the all-time, half-empty glass pessimist). But that's okay, he is someone else's problem now - LOL ;)

Positive = Possibilities...Negative = Nothing....Simple really (Smiling)

I'm off now to do my physical therapy excercises that are strengthening my legs, with the hopes of walking again with Tysabri's help. Darn it, there's that pesky word Hope again. (wink)

(((hugs)))

Love, Lauren <---Grinning from ear-to-ear, ending with a rebel yell of:
Woooooooohooooo!

A very proud member of MSpatientsforchoice.org

http://lauren-livingwithms-aolcomlglbgl2003.blogspot.com/

My Tysabri Diary...

After my 4th infusion, I have not experienced any "significant" improvements yet this time around on Tysabri, and I believe its due to the accumulating disabilities I've suffered for 18 + months not having Tysabri's superior efficacy to protect me from all the relapses I was having (approx. once a month).

I'm much more disabled now than most who currently receive Tysabri, and therefore I also believe I will need many more infusions before I see "dramatic" improvements.

The thing is...from my perspective, I am thrilled for others that show improvements so fast, and thrilled when a patient makes the switch to Tysabri or starts their therapy with Tysabri because I know they will be happy they did, just as I was in early 2005.

Right here, right now, I have experienced some minor improvements (which are HUGE for me)....but I'm sooooo not disappointed or disheartened that I'm not receiving the miraculous results I once had...I am thrilled that Tysabri (for me) is doing exactly what it has been designed to do: "...to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."

I haven't had a relapse, no increased disability, nor any disease progression since 10/06 - Wooooooohooooooo!

In my book, Tysabri Equals Hope, always.

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

My Tysabri Diary...4th Tysabri infusion under my belt! Woohoo!

Valentine's Day is coming soon .. I completed my 4th infusion today after a 90 min. travel time one way for my caregiver, and a 2 hr. drive back (we hit traffic coming home). No problems, not pre-treated with Benadryl this time, just a 20 min. pre-Tysabri infusion drip of Saline while a different nurse at Kaiser's infusion center went over the standard pre-infusion check-list (this was the first time she ever infused Tysabri in a patient - so she read, re-read and re-read the orders 3 times).

When the 20 min. Saline drip turned into 35 mins...she started to re-read them again, I asked her, "Please call the pharmacist to tell him the check-list is done, so he can mix my vial of Tysabri and we can get started, ... Then re-read the orders as many times as you like, okay?"

When she went to go get my Tysabri, I briefly spoke to the Infusion Administrator and asked her how many more patients are being infused there with Tysabri...she said none yet but she also said that [paraphrasing] they had received other TOUCH paperwork recently to process, but apparently 'there was a problem with Biogen/MSActiveSource's fax machine again (a multi-million dollar biotech's company still has a fax machine problem since October 2006??? Hmmmmm), and they 'finally' resolved that so other Kaiser patients are scheduled to be infused too...(she could not give me a number).

After a very long, long day, I am pretty tired so I'm turning in early tonight after a bite of dinner. #4 is now under my belt, and I usually feel an "overall feeling of strength with minor improvements here and there" within two days of my infusion....even though I'm beat right now, I am always excited to see what hope Tysabri delivers for me in the coming days (even if I only have the hope of no relapses or disease progression until my next infusion - I'll take it!), but I will always hope for more - heehee.

Goodnight all...,

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

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

This is from a message board that I frequent- the post below is from a gentleman who's wife has MS, and she just received her 5th Tysabri infusion (I believe):

"My wife continues to do well on Tysabri. No significant change in her status (which I will gladly accept).

Spoke to my wife's neurologist yesterday. Hadn't spoken with him for a few months. He states that he and his group have well over one hundred patients currently on Tysabri. One patient experienced an allergic reaction and had to discontinue. One patient developed a 'suspected' case of Herpes Zoster which may or may not be related to Tysabri. The patient is doing fine. No other side effects to report.

On the efficacy side, he states that most are doing well and FEELING BETTER. (Quality of Life). He has seen some patients improve on their neurological exams. One patient is out of her wheelchair. He remarked that hardly no one feels better on the interferons and while most tolerate Copaxone well (as long as one doesn't develop injection site reactions) he is not too impressed with Copaxone's efficacy.

Overall he is very pleased with Tysabri and continues to believe it is the best therapy available for MS today. He has stated to me a number of times that if he or a family member had MS, Tysabri would be his choice. I asked about what he has heard regarding other neurologists and their opinions regarding Tysabri. He stated that many are still scared of PML. He himself feels the risk/reward strongly favors tysabri."

Smart doc, if you ask me....wooooohoooooo! :)

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

My Tysabri Diary...

Okay, I'm sure you're wondering why I have a photo of Taz on my Blog page tonight. Well, a few of us MS'ers the other night were answering a "newbie's" question on a MS m.b., which was: "My neuro just rx'd steroids for me to calm down a flare-up I'm having, could some of you describe what is it like being on IVSM (steroids)?" ... a few of us were laughing & talking about our different (but similar) issues with steroids, and for me-in a nutshell-I basically turn into Taz, along with experiencing a host of other emotions while on steroids (such photos would be too graphic to post here-heehee) ...a sad but true fact. LOL

My 4th Tysabri infusion is scheduled for Friday, 1/19, and I will update my Blog shortly thereafter. I wonder if Kaiser remembered to order my med? Hmmm, Monday is a holiday - MLK's birthday...and even though I shouldn't have to, I'll call them Tuesday to double check, considering what happened last time - UGH!

I hope everyone had a happy Holiday season. I gained 4 lbs over the holidays ... (bummer) - time to cut back on sugar and butter - oh but it was SO worth it!

Now 4 lbs. might not seem like much (and it isn't really), but if I intend to continue making progress in being able to make chair transfers unassisted (and standing too), I cannot afford to ignore those 4 lbs. and just let more accumulate.....know what I mean, jellybean? (wink) ...take care all,

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

My Tysabri Diary...

Happy New Year everyone! Before I tell you how my new year began this morning (below), I'd like to answer a question raised recently in an anonymous comment on my Blog regarding Anita Smith from the Tysabri combo Trials (Sentinel) with Avonex that developed PML and died, as she did not have MS, nor did the Crohns patient that developed PML and subsequently died. In other words, no patient with a confirmed dx of MS that received Tysabri as a monotherapy (approx. 3,000 trial and 5,000 general population) from 11/04 through 2/28/05 (that's 8,000 patients) none developed PML and died...again ZERO, or a risk factor of 0:8000.

Pasted below are pertinent portions of the testimony provided to the FDA Advisory Committee in March '06 from her neuroradiologist, Gregory Shoukimas, MD, who testified that “Her autopsy report was published in the New England Journal of Medicine in 2005, and the results of that autopsy report indicate that she did not have any histopathological evidence of MS.” I have also pasted below the pertintent portions of testimony from Mark Godec, MD, who reviewed Anita Smith’s medical records at the request of her family. Anyone can research the FDA website for the full testimony transcripts.

Here are the pertinent portions of testimony indicated above:

9 DR. SHOUKIMAS: Good afternoon. My name
10 is Dr. Gregory Shoukimas. I am a neuroradiologist
11 and have been practicing for 20 years, and I am
12 here at the request of the Smith family. I am not
13 sponsored by Biogen, and I am not sponsored by any
14 competitors.
15 I am here to address primarily the issue
16 of the raw data, that is, the individual data that
17 a patient presents with and was enrolled in the
18 study, the Tysabri study. That is, how did Anita
19 Smith present clinically, what was her
20 symptomatology, what was her physical examination,
21 and what tests aided in making the diagnosis of
22 multiple sclerosis.
(225 of 356) [3/17/2006 10:41:27 AM]
1 In the talks that you have heard this
2 morning, it is assumed that Anita Smith had
3 remitting-relapsing multiple sclerosis, and that
4 has been called into question. I have no time to
5 go into the details of her physical examination,
6 but suffice as to say that her clinical
7 symptomatology was benign, relatively benign, was
8 not disabling, and certainly did not contribute to
9 her disability scores.
10 Her physical examinations for the most
11 part were normal. She showed very minimal signs of
12 decreased leg strength, spasticity, and slight
13 hyperreflexia.
14 In December of 2001, her physical
15 examination was entirely normal. She had reported
16 to her neurologist she was doing well, and she had
17 normal muscle strength in all major muscle groups,
18 but despite all this clinical information that was
19 available, she was being considered by her
20 neurologist for the Antegren or Tysabri study,
21 which she was told would be starting shortly, that
22 is, within three or four months.
(226 of 356) [3/17/2006 10:41:27 AM]
1 I had the fortune of talking with the
2 Smith family for about an hour, and it was related
3 to me by Mr. Smith and his daughter, Beth, that
4 from the time of her visit to enrollment in the
5 study, that is, the time of her first visit to the
6 neurologist to enroll in the study, she thought of
7 her problem as an annoyance.
8 She worked, carried the laundry up and
9 down stairs, clearly not indicative of a disabled
10 patient. She didn't get worse, and she didn't get
11 better. There was some indication that she had
12 visual problems, but this was never tested formally
13 with electrophysiology tests to confirm that she
14 had optic neuritis.
15 Her magnetic resonance imaging study in
16 1999, which I have reviewed, showed some
17 nonspecific white matter changes, and, in fact,
18 given her previous history of migraine, may have
19 reflected previous migraine. The changes were
20 nonspecific, and while demyelination was considered
21 criteria for this, for the diagnosis of MS was not
22 fulfilled.
(227 of 356) [3/17/2006 10:41:27 AM]
1 She had a cerebrospinal fluid analysis,
2 which was normal, including IgG assessment,
3 oligoclonal bands were nonexistent, and had one
4 lymphocyte, which is nonspecific.
5 Electrophysiology studies were not
6 performed especially visual, evoked potentials,
7 which would have been helpful in making the
8 diagnosis of optic neuritis.
9 Her clinical examination, as briefly, very
10 briefly detailed, but more fully talked about by
11 Dr. Godec later today, showed that she did not
12 really have two clinically symptomatic attacks and
13 that her objective lesions were not clearly
14 defined.
15 So, the question really is did Anita Smith
16 have multiple sclerosis. The talks again have
17 assumed that she had relapsing-remitting disease,
18 but, in fact, this was not ever clearly
19 established. If, in fact, it was present at all,
20 it was mild and stable with minimal neurological
21 manifestations, and any objective tests that might
22 have been helpful were ignored.
(228 of 356) [3/17/2006 10:41:27 AM]
1 These are the MRI scans, which were not
2 available when the New England Journal of Medicine
3 published its clinical pathological study detailing
4 the effects of MS on Mrs. Smith, and the Tysabri
5 results and the progressive multifocal
6 leukoencephalopathy which ensued.
7 These were the lesions that were described
8 as 9 lesions. These are two illustrative MRs.
9 There is a lesion back here. These are not very
10 typical of MS. They are nonspecific findings.
11 These are two patients that have MS,
12 similar in presentation, a little bit more severe,
13 more objectively defined disease, but these MR
14 scans are clearly contributory. There are some
15 lesions in the periventricular white matter, close
16 to the cephalo-junction region. In the Annals of
17 Neurology 2001, the McDonald criteria were
18 published, and clearly defined how MRs should be
19 interpreted with respect to MS. The MR scan that
20 Mrs. Smith underwent did not meet that criteria.
21 After her enrollment with two potent
22 immunosuppressant and modified immunomodified
(229 of 356) [3/17/2006 10:41:27 AM]
1 drugs, she was a minimally symptomatic patient
2 whose diagnosis was questionable, and yet she was
3 given the drugs, and progressive multifocal
4 leukoencephalopathy ensued, causing her demise....
(230 of 356) [3/17/2006 10:41:27 AM]
1 examination in the literature. Her autopsy report
2 was published in the New England Journal of
3 Medicine in 2005, and the results of that autopsy
4 report indicate that she did not have any
5 histopathological evidence of MS. In fact, the
6 report showed widely disseminated PML and evidence
7 of possible vasculitis.
8 The enrollment MRI I obtained on court
9 order was not available to the New England Journal
10 of Medicine at the time that the report was made
11 regarding her clinical history and ultimate demise.
12 The British Medical Journal and Lancet
13 have recently published articles also questioning
14 whether or not, in fact, Anita Smith had MS, and...
(231 of 356) [3/17/2006 10:41:27 AM]
1 other patients were enrolled as well, especially
2 since new clinical trials by Biogen Idec are
3 anticipated and possible approval of Tysabri for
4 clinical use is anticipated.
5 Thank you.
# # # # # # # # # # # # # # # # # # #

5 DR. GODEC: I am Dr. Mark Godec, a
6 physician in private practice in the Washington,
7 D.C. area. I have no financial interest in Biogen
8 and Elan, and I have not received financial support
9 from any competing companies.
10 I would like to thank the committee for
11 the opportunity to speak today.
12 Anita Smith was a healthy, active woman
13 until her final months and untimely death from PML...
(317 of 356) [3/17/2006 10:41:27 AM]
1 However, the medical evaluation that led
2 to the diagnosis of MS was incomplete and produced
3 results that were not diagnostic of MS. At most,
4 only her presenting episode provided objective
5 clinical evidence of a CNS lesion that might be due
6 to MS.
7 An MRI of her brain revealed only a small
8 number of nonspecific lesions that did not enhance
9 with gadolinium. Her CSF never showed oligoclonal
10 bands that are characteristic of MS.
11 EP studies were not performed and she was
12 not evaluated by a neuro-ophthalmologist...
(318 of 356) [3/17/2006 10:41:27 AM]
5 enrollment MRI actually shows only four or five
6 nonspecific lesions per Dr. Greg Shoukimas, who you
7 heard earlier today.
8 In November 2004, Ms. Smith developed much
9 more serious neurological signs and symptoms.
10 Tysabri was eventually discontinued, but her
11 condition continued to deteriorate.
12 Anita Smith tragically died on February
13 24th, 2005, from PML at the age of 46.
14 Neuropathological examination of her brain and
15 spinal cord revealed only PML lesions, and no MS
16 plaques, verifying that she did not have MS....
(319 of 356) [3/17/2006 10:41:27 AM]
14 Thank you very much.
*******

Now, on to happier news....My new year started today, when this morning, I was able to take one step again (not very graceful and kind of shakey) while holding onto my caregiver... BUT wooooooohooooooo!

Also see the following email that I received yesterday from another RemedyFind viewer...DOUBLE WOOHOO! Tysabri equals Hope!

Subj: Happy New Year
Date: 1/1/07 7:32:39 PM Pacific Standard Time
From: xxx
To: lglbgl2003@aol.com
Sent from the Internet (Details)

Thank you for the info you have posted on this site about Tysabri. I was a little scared to try it, but reading things like what you had written pushed me in that direction. I had my 1st infusion in Dec. and go again on Jan. 18th. The circulation has come back in my right foot and leg for the 1st time in about 2 years. That foot has remained freezing cold until about 10 days after my infusion when my whole leg got pins and needles and the warmth returned that same night. UNBELIEVABLE !!! I'm hoping that my foot drop and limp will begin to improve also. Thank you again for your encouraging words and I wish you the best of health for the New Year. xxx -------------------------------------------------------------------------------------------------------------
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2007 is looking good! Woooooooohooooooo and Yeeeeeeehaaaaaaaaaw!

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