Living With MS

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

Friday, July 03, 2009


Hi everyone, happy 4th of July tomorrow!

I wanted to post some additional information that was sent to me regarding the recent PML cases that have been linked to Tysabri..., as to prior treatments involving immunomodulators and/or very strong immunosuppressants, please note the following with regard to the Tysabri/PML chart that will be updated at a later time (my friend is currently on vacation for the next 10 days so it will have to be updated later)..., but specifically, the patients listed in the chart:

#7. Prior use of Rebif, Avonex, and Copaxone.

#8. Prior use of interferon beta 1-a (Avonex), and mitoxantrone (Novantrone).

#9. Prior use of Avonex, Rebif, and Novantrone.

#10. Prior use of interferon-beta, glatiramer acetate, and IVIG.

I am still waiting to receive information regarding prior use of medications for patient #6. It is most strange that no "prior treatments" information is given (and I'm not sure I'll ever receive this information). Once again, please note the prior use of very strong immunosuppressants and treatments such as Novantrone & IVIG are designed to suppress the immune system, and the different ABCRs were previously used to modulate the immune system.

Again, 8 out of the 10 new cases of PML occurred outside the US.


The above information can be found on the Élan website under Tysabri for Crohn's disease. Here is the Tysabri/PML chart which still needs to be updated:

http://pietynorwit.com/Tytable.htm


Have a wonderful and safe holiday tomorrow everyone!


((((hugs))))
Love, Lauren :)

Friday, June 12, 2009



My Tysabri Diary...,

Hi everyone, I had my 35th Tysabri infusion on Wednesday and my infusion nurse got a line in on the first stick, damn she's good (oops)

We were discussing how the different MS patients were doing on Tysabri ( at their infusion clinic). She did tell me that most of us are now stable (the majority of us are SPMS, and the permanent damage from prior relapses has already been done because we were without Tysabri-for various reasons of course).

However
, she did mention to me that their newest Tysabri patient is showing great improvements after just one Tysabri infusion such as she is now able to sleep through the entire night, has less aches and pains and less muscle spasticity, including improved eyesight. The patient has had MS for 10 years now, and her neurologist was not willing to watch her slide downhill, so he immediately switched her to Tysabri ( my infusion nurse could not remember which prior MS medication she was on, but my guess is probably one of the ABCRs). This newest Tysabri patient told my infusion nurse that she is really looking forward to her next infusion! God bless her neurologist for immediately switching her to Tysabri.

Within my post is a link for various UTube Tysabri videos, which I think are terrific & promote Tysabri from a MS patient's point of view. And below the link is an e-mail exchange that I had with a Tysabri patient which left a comment on my blog (she was so unbelievably sweet)..., I'm still a little tired from my infusion Wednesday, so I'll make this short -

Enjoy your upcoming weekend everyone ..., Lauren


Here is the link for the UTube Tysabri videos:



Here is my e-mail exchange as noted above, I'll start with the comment left on my blog which I answered via e-mail:

Subj: Tysabri
Date: 6/10/2009 3:53:35 PM Pacific Daylight Time
From: LGLBGL2003
To:
Right-click picture(s) to display picture options


Hi XXX, please call me Lauren..., it is so nice to meet you!

You said: "Is there anyone out there over 60 that's on Tysabri? After my 33rd infusion, my doc wants me to go off of Tysabri. I'm on it too long and my age factor is an issue. I'm Secondary Progressive. And I keep hearing that Tysabri is not for SP ms."

I will be 55 this year, and I just had my 35th Tysabri infusion today..., since when is your age factor an issue? Where does it state on the Tysabri label that you are not allowed to have Tysabri at your age?? I'm Secondary Progressive as well, with relapses. I have friends that are over 60 in the Tysabri trials, where exactly is your neurologist getting this misinformation from???

Tysabri is for "relapsing forms" of MS, and this includes Relapsing- Remitting, SPMS with Relapses, and Progressive Relapsing MS..., all of these forms of MS are in the inflammatory stages, whereas SPMS withoutRelapses and Primary Progressive are in the demyelinating stages of MS and Tysabri will probably not help in the demyelinating stages of MS.

If you go off Tysabri, you run the heightened risk of having increased Relapses, will it be worth it to you? Does your doctor understand that he is putting you at this risk??? Please discuss these questions with your neurologist.

You are more than welcome to e-mail me at any time, just please list Tysabri in the "subject line" of your e-mail so that it does not go into my spam folder and become deleted inadvertently.

Take care dearheart...,

Lauren


Subj: Re: Tysabri
Date: 6/11/2009 10:03:53 AM Pacific Daylight Time
From:
To: LGLBGL2003@aol.com
Sent from the Internet (Details)


Hi Lauren, Are you the same Lauren with the that has a blog?
Thanks for the encouragement on my dilemma. I'm scheduled for my next infusion on the 18th. My doc told his physician's assistant to call me on the 16th to let him know of my decision. As of this moment I do plan to go ahead with the infusion. I am now contemplating finding another doctor for a second opinion.
I live in XXX. I go to an MS clinic at Lehigh Valley hospital in Allentown. My former doctor at Lehigh left to move to Ohio. He's the one that put me on tysabri. The clinic is good. I hate to start all over with another doctor. Good doctors are hard to find.

Thanks for your response. Please keep in touch. My name is XXX.


Subj: Re: Tysabri
Date: 6/11/2009 3:06:58 PM Pacific Daylight Time
From: LGLBGL2003
To:
Right-click picture(s) to display picture options


In a message dated 6/11/2009 10:03:53 AM Pacific Daylight Time, XXX writes:

Hi again XXX, you ask:

Are you the same Lauren with the that has a blog?


Yep, that be me! I reviewed your questions on my blog under the comments that you and others left.

Good for you in going forward with your next infusion. If your doctor refuses to let you continue with your Tysabri uninterrupted, it does appear that you're going to have to find a different neurologist. I do know that changing doctors can become a real hassle, but you have one major plus on your side...,You are already on Tysabri therapy! As far as finding a new doctor, just call your Tysabri Case Manager at MSActiveSource ( 1-800-456-2255 ), and tell them you need three names and phone numbers of Tysabri "Certified" neurologists near you - all you have to do is provide them with your ZIP code. More than likely, the three names & phone numbers of the doctors they will provide you are MS specialists, and that's a good thing. Oh gosh, I'm starting to sound like Martha Stewart again! Heehee

Please keep in touch with me and let me know if you were able to find a new doctor, or e-mail me if you have any other Tysabri questions, okey-dokey artichokey?

All my very best to you, always -

Lauren

Friday, May 29, 2009




My Tysabri Diary.....,

Hi everyone, I received the following message from a new MS friend I made yesterday, and I have her permission to post this on my blog:

"I want to thank you for your Tysabri Talk thread. I know you get accused of being a "Tysabri cheerleader," but why wouldn't you be? I hope it works for me, and I'll don the mini skirt and be right next to you, shaking those pom poms! Since my dx 7 years ago, I have been watching every single development in MS medications very carefully, and when Tysabri came out I was excited, but I knew I wasn't really a candidate yet for such a new medication. It's scary how quickly I DID become a candidate, though. And I have never seen anyone accused of being a Betaseron, Copaxone, Avonex, or Rebif "cheerleader," because let's face it... at best they're merely tolerable and might help slow progression down a little, and at worst they're fraught with miserable side effects, and don't slow down progression at all. So this enthusiasm for Tysabri I've witnessed (on multiple different MS message boards I frequent) is really genuine, fairly rare among available treatments, and growing at a significant rate.

I've consulted two neurologists, one my regular "everyday" neuro, and one an MS specialist, and both concur this is the best medication out there, and I need to be on it. They quote the PML "official" risks, but both sort of rolled their eyes, "You're not gonna get PML." They have many patients on it, and have seen great success, so I trust what they say. And after being in a relapse for 6 months, I just refuse to keep going like this. Quality of Life, dammit! So I don't care how many times the Angel of Death posts the newest PML case on the board (I think you know who I mean; her name escapes me), I really have no fear of it. Honestly, the last 6 months have been really tough; I don't want to live like this anymore. PML is really the least of my worries. I mostly fear it not working... that would be the true tragedy for me. But I am optimistic!"

Enjoy your upcoming weekend!

((((hugs))))

Love, Lauren :)

Monday, May 25, 2009



A big, BIG thank you for all the wonderful comments left on my blog..., honestly, some of you are so thoughtful and encouraging!

Because it is Memorial Day today, I won't be online much but nevertheless, I wanted to wish you all nothing but the very best and hope you are able to share your time and love today and always with friends and family while you still can.


((((hugs))))

Love, Lauren :)

Sunday, May 24, 2009



My Tysabri Diary...

Happy Memorial Day everyone! I completed my 34th Tysabri infusion on May 13, and all went well.

Here are a couple of interesting observations I've made over the last two weeks:

1. There are some MS patients are still afraid of Tysabri (see the message below that I received from a MS patient);

2. A startling report from the Institute For Safe Medication Practices dated May 7, 2009 and you will specifically note pages 9 (see the chart below for the interferons: Avonex, Betaseron, & Rebif were the leading medications which caused serious, disabling, or fatal adverse events) as well as pages 11, 12, & 13 which specifically states the following:


"The interferon beta case reports for all three drugs, however, did suggest a possible additional risk of cancer—an adverse effect for which warnings do not currently exist. The latest quarter of data included 131 possible cases of cancer, including reports of cancers of breast, lung, prostate, ovary, thyroid, esophagus, colon, rectum, kidneys, brain, liver, kidneys, bladder and skin. Since the drugs were first approved we noted 1,338 reported cases of possible malignancies."

Here is the chart that I was referring to on page 9:

Table 1. Serious, disabling and fatal events in 2008 Q3
Drug Name Cases Rank

INTERFERON BETA 1380- 1
DIGOXIN 1023- 2
BACLOFEN 872- 3
VARENICLINE 659- 4
ESTROGENS 586- 5
ROSIGLITAZONE 494- 6
ETANERCEPT 412- 7
INSULIN 399- 8
EXENATIDE 399- 9
INFLIXIMAB 369-
10 (a.k.a. Rituxan)
FENTANYL 369- 11
QUETIAPINE 339- 12
ADALIMUMAB 336- 13
DIANEAL 335- 14
NATALIZUMAB 319- 15 (Natalizumab/Tysabri rated last on this list)


Here is the full report: http://www.ismp.org/quarterwatch/2008Q3.pdf

Here is the comment/message that I receive via a PM from a MS patient that is going to start Tysabri next week, and she was scared to death (I get these all the time, and after I explain the accurate facts of Tysabri do them, their responses are usually the same as this one below):

Thank you for your post on Tysibri. I am going for my first infusion next week and I am scared to death. I have been so worried about the scary side effects. PML in paticular. I have done a lot of research and your post and the comments after have helped me a great deal. Thank you again!!!!!!!!!!!!!!!!!!!!!!!

Here was my reply to her:

Hi there! (Sorry, I don't know your first name)...,

I think it's wonderful that you're about to start Tysabri (I just had my 34th infusion a couple of weeks ago)..., in my opinion (and I'm not a doctor) you really don't need to be scared of PML unless your immune system is severely suppressed. The expert authors of the New England Journal of Medicine indicate that PML is caused by a diminished immune system, not by Tysabri.


And if your neurologist pretreats you with a Benadryl drip for 30 minutes just prior to your Tysabri infusion, or if you take a Claritin-D tablet (like I do) approximately 1 hour before your infusion, this can drastically reduce the possibility of having any side effects.

It's always best to speak to your neurologist.

Relax, you're going to be on the most effective MS medication we have to fight our MS, woo hoo!

Good luck and please let me know how your first infusion goes next week, okey-dokey artichokey?

All my best you, Lauren


Here was her final reply to me:

Thank you Lauren! My name is XXX by the way! I will let you know for sure. You have eased my fears a lot!
Have a great Weekend!!!!!!
~XXX

As to this latest case of PML that just surfaced, I do not know this patient's past medical history with regard to medications that she was on.

I wrote to Biogen requesting this information, but I do not know whether or not they will release this information to me. Once I find out, I will post the information on my blog.

My guess is she was probably already immune suppressed and this could be due to being on prior medications such as Azathioprine/Imuran, Methotrexate, Novantrone, or regular pulse steroid use, etc.

In light of the unbiased current serious, disabling, and fatal/adverse events report of the interferons indicated above, I still don't understand why MS patients are so afraid of Tysabri when it is the
most effective MS medication we have to fight our MS. Maybe someday they will, I just hope it's not too late for them.

Have a safe & happy holiday weekend!

((((hugs to all))))

Love, Lauren :)

Thursday, April 30, 2009


Hi everyone, for those of you looking for accurate Tysabri information...,

These are various reports/data which were released awhile ago at the AAN regarding the outcomes of Tysabri meeting and exceeding primary endpoints and the newest data released 61st annual AAN meeting which shows that Tysabri promotes remyelination, woo hoo!


As to efficacy in preventing further relapses, the percentages of the different ABCR drugs versus Tysabri (67%-29%) were as follows:

Tysabri was 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%.

Data Show Tysabri Had Improvement in Quality of Life Assessments

Tysabri Impacts Measures of Visual Function

Tysabri Impacts Measures of Disability Progression

Data Demonstrates Tysabri Significantly Reduced Corticosteroid Use, Hospitalizations and Increases the Proportion of Disease-Free Patients

Tysabri Has Sustained Effect on Relapse Rate in Multiple Sclerosis Patients Treated for up to Three Years

Tysabri Significantly Reduces Vision Loss Tysabri

Demonstrates Significant Improvement in Cognitive Function in Patients with Multiple Sclerosis

Tysabri Demonstrates Significant Improvement in Functional Outcomes

Tysabri Is the Only Marketed MS Treatment To Show Both Significant Slowing In Disability Progression and Sustained Improvement in Physical Disability

***28 April 2009** MRI Data Showing Tysabri Promoted Remyelination Presented at the 61st Annual Meeting of the American Academy of Neurology -- Additional data suggests improvement in Tysabri patients across clinical and patient-reported outcomes

http://www.elan.com/News/full.asp?ID=840112

http://www.elan.com/News/full.asp?ID=913012

http://www.elan.com/News/full.asp?ID=910437

*** http://www.elan.com/News/full.asp?ID=913012 ***

http://www.medpagetoday.com/Ophthalmology/GeneralOphthalmology/tb/5453

*** http://www.elan.com/News/full.asp?ID=910099 ***

*** http://www.elan.com/news/full.asp?ID=1199030 ***

*** http://www.elan.com/News/full.asp?ID=1281713 ***

Hope this information helps those of you looking for accurate Tysabri information..., enjoy the rest of your week everyone, I know I will!

((((hugs))))
Love, LaurenSmile

Friday, April 24, 2009




My Tysabri Diary...

Hi everyone, I completed my 33rd Tysabri infusion last Wednesday (wow, have I had that many already?). Everything went fine and I even found out that my neurologist started another patient on Tysabri, woo hoo!

With respect to the latest PML case reported, I am not concerned at all... in fact, I would like to share with all of you the following (these remarks are from a treating neurologist that prescribes Tysabri and is an acquaintance of mine):

"Tysabri

The Benefits

1. Reported reduction in relapse rates 100% better than any exisitng therapy. Comparable MRI results.

2. Reported reduction in disability of progression up to 50% better than any existing therapy. Since this is a LAGGING indicator, expect the reduction in disability progression to get better and better (COMPOUNDING) assuming yearly reduction in relapse rates holds.

3. First drug to show quality of life improvements

4. First drug to show IMPROVEMENT in visual function

5. First drug to show reduction in fatigue

6. First drug to show significant subset of patients demonstrating IMPROVEMENT in EDSS scores.

7. First drug to demonstrate significant HAULT in ALL evidence of disease activity for a significant subset of patient population.

8. First drug to demonstrate significant improvement in patients with highly active MS

9. First drug to show significant improvement in Cognitive function (to be presented at an upcoming MS conference

10. First drug to show in-vivo evidence of re-myelination


The Risks -

1. Increase risk of liver enzyme elevations......... in very rare patient - jaundice

2. Increase risk of opportunisitc infections - small increase risk of herpetic reactivation

3. PML - 6 confirmed cases since re-introduction out of over 55,000 patient exposures, 40,000 active patients, and probably upwards of 40,000 patient years of drug. Well within label.

One death - I have been told that this one patient death was from IRIS and that patient and/or family refused hospitalization and treatment (to be hopefully confirmed at AAN)


PML serious potential side effect, with often moderate to severe neurological sequella. Importantly, NOT a death sentence, and can be detected early through clinical vigilence. MAY be treatable through PLEX and methoquine.

As to the most current MS patient that developed PML, this is from a German blog, and also a German friend of mine stated "the docs out there were amongst the first to leave the DDR via Hungary - before the wall fell.

With docs and nurses gone west - add techers too - the DDR was about to lose so many qualified people , which the state depended on, that this fact was one of the major reasons they finally had to open the border. Many of the docs who escaped the DDR have moved back since.

What I have seen from patients' posts - was that TY had been prescribed for patients who would normally not qualify as RRMS .... many of them claiming you just had to go to certain ms-centers --- in Leipzig or Dresden, know what to say and you would get your TY.

The following has been translated from a German blog:

formerly East-Germany.
15.04.2009 ? 31 Monate ? ? 6
Anmerkung: weitere Informationen folgen. Spekulation: Ist Deutschland nicht das einzige Land, außer den USA, indem Tys vor 31 Monaten schon zugelassen war? Gerüchteweise Dresden
Tini

Hallo,

ich war heut bei meinem Neurologen. Er hat mir gesagt, dass der 6. PML-Fall in Dresden ist.
Ich hoffe Pit, deiner Frau geht es besser.

Ich wünsche dir viel Kraft und ihr alles alles Gute.
Tini says that she had been to her neurologist today and he told her that the 6th case was from Dresden

She also stated: "But, I would say that there are also Neuros in western Germany, who treat their patients with mainly Aza and Mitox, due to low costs ( imo )

I know that for maybe 10 years now, docs in general have to prescribe generica - if they are exactly the same compounds as the original med-

Many patients write that they will take Ty "nevertheless" ( pml fear ) because " what else is there left for us to go on ?"

I hope BIIB sees what they are doing with their 1st Avonex policy :they degraded Ty to an escalation therapy, which means to some neuros, try everything else first and then TY.

It only takes a few of these uninformed specialists ...who think they are informed, but never take the time to read the newest abstracts."

Take care everyone,

((((hugs))))
Love, Lauren Cool

Sunday, April 12, 2009

My Tysabri Diary..

Happy Easter everyone!

Whether or not you are a believer in Easter, I wanted to share a beautiful story of the white Easter Lily, a funny photo of two chocolate Easter bunnies (I think I've shared this before but I still find it a very funny photo), and a hysterical "Bunny Rap" which should put a smile on your face - LOL

My Easter prayer this morning is that each of you be blessed beyond belief with good health, a loving family/friends to share your life with, financial prosperity, and a happy heart...,

Easter blessings one and all!

Lauren

On Easter Day the lilies bloom,
Triumphant, risen from their tomb;
Their bulbs have undergone rebirth,
Born from the silence of the earth
Symbolically, to tell all men
That Christ, the Savior, lives again.
The angels, pure and white as they,
Have come and rolled the stone away
And with the lifting of the stone,
The shadow of the cross is gone!
June Masters Bacher



Here's the hysterical "Bunny Rap"..., enjoy! Bunny Rap


Wednesday, March 18, 2009


My Tysabri Diary...

Hi everyone,

I just returned home from my 32nd Tysabri infusion, all went well this time as my regular infusion nurse was there, and she got me on the first stick, yay!

It was pretty quiet in there today, and really nothing new to report..., although a friend of mine that just changed over to Kaiser and also receives Tysabri, wanted to know if we can have our infusions together, so we're trying arrange that for next month.

During the last couple weeks, I had the pleasure of working with a friend of mine that prepared a Tysabri/PML chart posted here:

www.pietynorwit.com/Tytable.htm ,

which I hope helps to explain that the MS patients who developed PML were severely immune suppressed due to prior medications they had been on. We will try to keep it updated as time goes on, if necessary.

Ray is on his way to pick up mudslides & pizza for dinner..., I'm pretty tired right now and I just wanted to check in to let everyone know my infusion today went much better than last month.

I have a ton of e-mails to read & reply to before Ray returns, so I bid you all a wonderful evening. Take care everyone,

A very tired Lauren :)

Tuesday, February 24, 2009

My Tysabri Diary.....,

Hi everyone,

I had my 31st Tysabri infusion last Wednesday. My regular infusion nurse was not there that day, nor was her backup, so a lesser experienced infusion nurse had to stick me three times to get a good line in (owie!)

Below are some Tysabri charts/graphs that an acquaintance of mine compiled from Tysabri patient reports being posted on a MS forum that I belong to. A friend of mine sent them to me and I am on posting them on my blog as well.

Also, below is my reply to a post from a patient that is, how should I say this politely, not very Tysabri friendly and never has been... she is always posting negative and erroneous misconceptions about Tysabri on various MS boards.

Anyway, hopefully each of you will have a good week.

((((hugs))))

Love, Lauren :)

Tysabri side effects
Tysabri Efficacy
Tysabri Dropout Rate

Tysabri responding patients
(Percentage of patients responding to various "Tysabri Polls”)

This reply is in response to the post by XXX Re: the IRIS condition and other various misconceptions/assumptions...,

The patient who died was a United States patient who had received 14 monthly infusions of Tysabri as a stand-alone treatment. Previously she had received other therapies, including methotrexate for her RA condition... methotrexate has been specifically linked to causing PML.

Unfortunately, methotrexate has been positively associated with PML because of its extremely strong immunosuppressive actions. See page 1 of the following NEJM article, which states the following:

"Progressive multifocal leukoencephalopathy (pml) is a rare, oligodendroglial infection caused by the polyomavirus JC virus. It [PML] usually occurs in people infected with the human immunodeficiency virus (HIV), but it has also been reported in immunocompromised patients receiving prolonged treatment with methotrexate, cyclophosphamide [a.k.a. Cytoxan], and azathioprine [a.k.a. Imuran].." Here is the link for the New England Journal of Medicine article:

http://content.nejm.org/cgi/reprint/353/4/375.pdf (NEJM)

After developing the brain infection, the patient was treated with a procedure known as plasmapheresis, in which blood is removed, cleared of the drug, and replaced.While the U.S. patient died, two patients who developed PML in Europe, and whose cases were announced in July, appear to be recovering following treatment, even though one had not been expected to survive. Earlier this month, Biogen announced that a fourth patient had developed PML. This patient, in Europe, is still alive.The European patient that had not been expected to survive had developed a condition known as immune reconstitution inflammatory syndrome, or IRIS. This occurs when the immune system, in eliminating an infection, produces an excessive inflammatory response that can worsen symptoms.

From an e-mail reply that I received from the Senior Director of Research Information of the NMSS which posted information/their opinions regarding IRIS, she stated "What is not known is whether IRIS would have occurred whether PLEX was performed or not. Further experience will probably answer that and many other questions as time goes by....Biogen Idec is to be applauded for supporting research into PML and possible ways to quickly clear the system of their drug when it's deemed necessary."

"Geoff Meacham, an analyst at J.P. Morgan, said it seems likely the U.S. patient, having gone through plasmapheresis, died of IRIS... ", Mr. Meacham is a financial analyst, not a doctor/researcher.

Drugs that have been known to cause PML include Imuran/Azathioprine, regular steroid use, Rituxin, Remicade, CellCept, methotrexate, Raptiva, etc, and to unfairly single out Tysabri causing PML/IRIS is ludicrous.

All of these patients that developed PMLwere previously treated with one of the following: Remicade, Imuran/Azathioprine, methotrexate, regular steroid use, and possibly CellCept in the latest PML case. So as you can see, all of these patients received strong immune suppressing medications which can last in the body for years (even though previously discontinued by the patient) prior to starting Tysabri therapy.

As of end of December 2008 there were approximately 37,600 patients currently on therapy. A total of 52,900 have been treated with Tysabri at some point in time (clinical trials, first launch, second launch), so the 1:1000 risk of developing PML is still well within the guidelines as listed on the label.

And Jan, you're more than welcome for the information Smile

Lauren

Friday, January 23, 2009



My Tysabri Diary.....,

Hi everyone,

I had my 30th Tysabri infusion on Wednesday..., all went fine. My infusion nurse even got me with just one stick, yay!

Nothing really new to report other than my very small infusion center has two new Tysabri patients, yay again!

Since my MS is remaining stable while on Tysabri, I have received a few e-mails over the last two weeks from MS patients that were inquiring about these deaths, taking a "medication break", and if I'm scared of PML, etc...., also answering the same questions on the different MS boards that continually visit. I've also been correcting misinformation posted about Tysabri on various MS blogs.

What I do find very interesting is that one particular MS board/blog that hosts over 3000 MS patients, their friends, their families & caregivers is that more and more MS patients are posting their experiences while on Tysabri and most of their experiences have been more often than not very positive, encouraging, and upbeat... (this is a very drastic change from a year ago when there were only a few of us posting on that MS/blog).

I guess such a welcome "change" doesn't only apply to our government (heehee).

I'm off to do my physical therapy, so I have a great weekend everyone. My best to you all,

((((hugs))))

Love, Lauren :)

Thursday, December 25, 2008




My Tysabri Diary...,


I had my 29th Tysabri infusion yesterday, all went well, and it was pretty quiet being that it was Christmas Eve at my infusion center..., one thing of interest happened there yesterday..., a gentleman was having Remicade for his RA (he usually has a pretreatment with Benadryl, but declined it yesterday), and he developed an allergic reaction almost immediately.

The infusion nurse stopped his IV, and then administered Benadryl..., I mentioned to him that Claritin-D tablets work really well (Claritin-D is what I take to pretreat my Tysabri infusions), and that he my want to discuss using same with his doctor, rather than pretreating with having Benadryl. He said he definitely would.


Also, I've been really busy answering all the questions on the different MS boards and e-mails about the latest PML case/death..., I will answer them here as well; there is some additional information which was posted by Biogen on the SEC filings website, which they are required to do:

Here is the link: http://tinyurl.com/54x5rm (US Securities & Exchange Commission)

Basically, it states the following:

"• Background:

- Patient has a history of MS and prior disease modifying therapies, including beta-interferons and glatiramer acetate.

- Patient had also received prior therapy with methotrexate for a rheumatological condition.

- Patient received 14 infusions of TYSABRI monotherapy.

- Clinical vigilance led to early identification of signs and symptoms of possible PML and to clinical evaluation which included MRI scanning and CSF testing.

- Patient is under the care of patient’s treating physician."

Unfortunately, methotrexate has been positively associated with PML because of its extremely strong immunosuppressive actions. See page 1 of the following NEJM article, which states the following:

"Progressive multifocal leukoencephalopathy (pml) is a rare, oligodendroglial infection caused by the polyomavirus JC virus. It usually occurs in people infected with the human immunodeficiency virus (HIV), but it has also been reported in immunocompromised patients receiving prolonged treatment with methotrexate, cyclophosphamide, and azathioprine."

Here is the link for the New England Journal of Medicine article:
http://tinyurl.com/4qeddp (NEJM)

I hope this information helps. So anyway, I wish you all the very best the holiday season, and a very happy, healthy, and promising New Year!

Again, Merry Christmas!

((((hugs))))


Love, Lauren :)

***Christmas Visitors (a Christmas card from Jacqueline Lawson, this card reminds me of the Christmas' I had in the past)

http://www.jacquielawson.com/preview.asp?cont=1&hdn=0&pv=3150426

***Plus One - "This Christmas" (the words are listed in the video)
http://www.youtube.com/watch?v=IujRQWgMqr4

***Celine Dion - "Ava Maria" (some of the words are Italian and I did my best to translate them, so please forgive me if some of them are wrong)

http://www.youtube.com/watch?v=l99JjYWyjoU&feature=related

Ave Maria
Maiden mild
Oh listen to a maiden's prayer
For thou canst hear amid the wild
'Tis thou 'tis thou canst save amid despair
We slumber safely till the morrow
Though we've by man outcast reviled
Oh Maiden see a maiden's sorrow
Oh Mother hear a suppliant child
Ave Maria
Ave Maria gratia plena
Maria gratia plena
Maria gratia plena
Ave ave dominus
Dominus tecum
The murky cavern's air so heavy
Shall breathe of balm if thou hast smiled
Oh, Maiden, hear a maiden pleadin'
Oh, Mother, hear a suppliant child
Ave Maria
Ave Maria

***Celine Dion - "Another Year Has Gone By"

http://www.youtube.com/watch?v=Rcr6bBVf6D0

So many 25th's of December
Just as many 4th of July's
And we're still holding it together
It only comes down to you and I

I know that you can still remember
Things we said right from the start
When we said that this could be special
I'm keeping those words deep down in my heart

Another year has gone by
And I'm still the one by your side
After everything that's gone by
There's still no one saying goodbye
Though another year has gone by

I've never been much for occasions
But you never let another birthday go by
Without announcing how much you love me
But the truth was always there
Right there in your eyes

And we're still holding hands when we're walking
Acting like we've only just met
But how can that be - when there's so much history?
I guess that's how true lovers can get

Another year has gone by
And I'm still the one by your side
After everything that's gone by
There's still no one saying goodbye
Though another year has gone by

Another year has gone by
And I'm still the one by your side
After everything that's gone by
There's still no one saying goodbye
Though another year has gone by

Thursday, November 27, 2008




My Tysabri Diary...

28th Tysabri Infusion Report & A Happy Thanksgiving Message...,I got home late yesterday afternoon from my 28th Tysabri infusion, everything went fine and nothing new to report other than feeling a little tired..., so I went to bed early last night.

I wanted to wish everyone a very happy Thanksgiving, and below are some thoughts that I want to dedicate to my wonderful friends who touch my life with the treasure of their being... May your soul decisions always be made with your heart, and not your head. (the words below were shared with me by a friend, and I wanted to share them with you as well).

Happy Thanksgiving Everyone! Lauren :)

1. Don't go for looks, they can deceive. Don't go for wealth, even that fades away. Go for someone who makes you smile.

2. There are moments in life when you can miss someone so much that you want to pick them up from your dreams and hug them. I hope you dream of that someone.

3. Dream what you want to dream, go where you want to go, be what you want to be, because you have only one life and one chance to do all the things you want in life.

4. May you have: Enough happiness to make you sweet
Enough trials to make you strong
Enough sorrow to keep you human
Enough hope to make you happy
And enough money to keep you comfortable

5. When one door of happiness closes, another opens. But we often look so long at the closed door, that we don't see the one which has been opened for us

6. The best kind of friend is the one you can sit on a porch with, swing with, never saying a word and then walk away feeling like that was the best conversation you've ever had

7. It's true that we don't know what we have until we lose it, but it's also true that we don't know what we've been missing until it arrives

8. Always put yourself in others' shoes. If you feel that it hurts you, it probably does hurt the other person too

9. Every careless word may kindle a strife
A cruel word may wreck a life
A timely word may level stress
A lovely word may heal and bless

10. The beginning of love is to let those we love be perfectly themselves and not twist them with our image otherwise we love only the reflection of ourselves we find in them

11. The happiest people don't necessarily have the best of everything, they just make the most of everything that comes along the way

12. Maybe God wants us to meet a few wrong people before meeting the right one so that when we finally meet the right person, we should know how to be grateful for that gift

13. It takes a minute to have a crush on someone, an hour to like someone, and a day to love someone, but it takes a lifetime to forget someone special

14. Happiness lies for those who cry, those who hurt, those who have searched and those who have tried. For only they can appreciate the importance of people who have touched their lives

15. Love is when you take away the feeling, the passion, the romance and find out you still care for that person

16. A sad thing about life is that when you meet someone who means a lot to you and then only to find out in the end that it was never meant to be and you just have to let go

17. Love starts with a smile, develops with a kiss, and ends with a tear

18. Love comes to those who still hope even though they've been disappointed, to those who still believe even though they've been betrayed, to those who still need to love, even though they've been hurt before

19. It hurts to love someone, and not be loved in return but what is most painful is to love someone and never find the courage to let the person know how you feel

20. The brightest future will always be based on a forgotten past. You can't go on well in life until you let go of your past failures and heartaches

21. Never say goodbye when you still want to try;
Never give up when you still feel you can take it;
Never say you don't love that person anymore when you can't let go

22. Giving someone all your love is never an assurance that they'll love you back. Don't expect love in return, just wait for it to grow in their hearts, but if it doesn't, be content it grew in yours

23. There are things you love to hear but you might never hear it from the person whom you would like to hear it from, but don't be deaf to hear it from the person who says it with all their heart

24. When you were born, you were crying and everyone around you was smiling. Live your life to the fullest so that when you die, you're smiling and everyone around you is crying

Author Unknown


Here is a really nice Thanksgiving card from Jacquie Lawson (this was shared with me by my friend Cyndee..., Yum!):

http://www.jacquielawson.com/preview.asp?cont=1&hdn=0&pv=3111922

Saturday, November 01, 2008

My Tysabri Diary...,

First of all, I have/had been helping a fellow MS patient that had to go off of Tysabri therapy because he could no longer afford the exorbitant costs of his monthly infusions...., his name is Vic (I have his permission to use his first name). If any MS patient currently on Tysabri therapy is having the same problems as Vic, please write to me at LGLBGL2003@aol.com , giving me detailed information about the financial problems/insurance problems you are having with your infusions, I will not only write to you further, I will write to my contact over at Élan to see if anything can be done for you.

I had initially contacted the Patient Services Supervisor over at Biogen and after about a week, they had temporarily resolved this MS patient's situation, however subsequent to that time, I received a phone call from this person the following week and I was told that there was nothing further that they could do & unfortunately, everything was going to revert to the same way it was before their intervention the following month. Therefore, this patient as well as 12 other patients in his neuro team's practice, had to definitely drop out of the Touch program because their monthly financial output for their therapies was making it impossible for them to continue on Tysabri.

When I had nowhere else to turn to try and get assistance for this patient, I contacted Élan (the company that discovered Tysabri, Biogen's partner with regards to Tysabri). Below are a few of our various paraphrased e-mail exchanges between my contact over at Élan, myself, and the patient - after just two days of Élan being made aware of this situation (I advised them on a Friday - so obviously, they worked on this problem over the weekend!), Vic is now going to start back on Tysabri therapy November 4th and all of the other MS patients that were in his neuro team's group are also able to resume their Tysabri infusions...., Woo hoo!

In addition, I had my 27th Tysabri infusion Wednesday..., all went fine, although I'm still feeling a little tired. When my infusion nurse told me what happened with the paperwork we filled out over a month ago regarding the changeover to my new neurologist, ummmmm, let's just say that not only was I not surprised at Biogen/MSActiveSource's inaction, grrrrrr, but I definitely let the person that has been helping me over at Élan know what happened, and I have been assured that the the information I provided will be sent to the appropriate person(s) at Biogen....,

Here are portions of the different e-mail exchanges I have had with Biogen, Élan and the MS patient Vic...,

My initial e-mail exchange (paraphrased) between me and Vic:

Oh Vic,

I read your post on "X" MS board that you were having to stop your Tysabri treatments due to the exorbitant cost of the infusions charged by your infusion center.

Have you contacted your Tysabri Case Manager at 1-800-456-2255 and asked them to assist you in finding a less expensive charging Touch certified infusion center near you? Also, have you asked them about any programs they have to assist you with your co-pays? If you have and received no help from them, have you asked to speak with a Tysabri "Team Leader" that supervise the Tysabri Case Managers?

Most importantly, have you reported that infusion center to the California State Insurance Commissioner (http://www.insurance.ca.gov/contact-us/
) for price gouging with regard to the overcharging of the infusions and/or have you appealed their billing practices? Or have you contacted the California Consumers Hotline in that department at http://www.insurance.ca.gov/0100-consumers/0400-talk-to-us/index.cfm ? It is a toll-free number.

I know of several Tysabri patients that have switched infusion centers to one that does not overcharge exorbitant prices for their infusions...,

Just trying to help..., this is a terrible situation and I want to try to help you if I can, please let me hear from you at your earliest convenience...I wish you only the best Vic.

Lauren

Initial e-mail reply (paraphrased) from Vic to me:

Thanks, Lauren.

I have done everything that you noted in your e-mail but the cost is still beyond belief. Spending thousands each month is no longer a viable option.

I know of a bunch of people who have been hit by this fiasco and have all quit infusion medications. Most have gone to either Beta or Rebif.

Biogen has been wonderful to me in that they have reduced the cost of Tysabri to a very good price for me, but the infusion center(Wilshire Oncology) refuses to budge.

I will just press onward with Rebif and see how things go.

I hope things are going well for you.-Vic

After questioning Vic further as to what exactly his infusion center/and insurance situations were, I received the following...,

Subsequent e-mail (paraphrased) that Vic sent to me:

Lauren,My neuro team is infuriated over the infusion costs ($675), and happy that Biogen has helped reduce the Tysabri costs(~$2,500 per dose). But the cost of my insurance ($12k/yr) plus the cost of the infusions has driven me away from Tysabri. So far, over the past 18 months we have spent about $120K on Tysabri, infusons, check-ups, urology because of UTI's, MRI's, etc, etc, etc). When I was using Avonex the total cost out of pocket was $200/year. And now Rebif will only be charging me $51/month or about $600 per year. I realize that Rebif may not be effective, but some medication must be used at this time.The amazing thing is that if I had no insurance and no assets, Tysabri+infusions would be free.-Vic

Initial e-mail exchange (Paraphrased) between me and Biogen: ..., I'm contacting you to see if you can possibly intervene on behalf this patient because not only is he having to drop Tysabri, there are at least 12 other patients in his neurologist's group that are also having to drop out of the Tysabri program due to the exorbitant infusion costs...., and if this is happening to not only them, I'm sure that there are hundreds, if not thousands, more MS patients that this is happening to...., Vic also advised me that:
"My neuro-team has many cases like mine wherein infusion center costs have prevented the continuation of Tysabri" ..., (After about a week of Biogen working on this problem, the situation was temporarily resolved, and when I advised them of the final outcome which was still preventing this MS patient from continuing his Tysabri infusions, I subsequently received a phone call a couple of days later and was basically told that there was nothing further Biogen could do for this patient as they must look at each patient on a "case by case" basis, requiring each patient to first contact their Tysabri Case Manager to see what can be done. )... ARRRGH!

Subsequent e-mail exchange (paraphrased) between me and Vic:


My old infusion center nurse called me last night and said that they now only have eight Tysabri patients left, when they used to have as many as 46. Of the eight remaining, three of them will be leaving soon because fo the cost of the infusion. That will only leave five of the original 46 still on Tysabri. Yikes! My neuro-team is absolutely disgusted with the entire process and like you, they have exhausted every avenue at their disposal. It looks like I will be on Rebif as soon as the Tysabri clears my system.Thanks again for doing so much for me and all of the others who have had to quit Tysabri. -Vic

Initial e-mail exchange (paraphrased) between me and Élan:
...
a situation has come up with a MS patient that has been on Tysabri for quite some time, and he was doingstayswell on it, but had to go off of the therapy because of the exorbitant costs that the different infusion centers were charging him, and even though he had private insurance, he could no longer afford his monthly monetary output for same. (note, I sent them all of my e-mail exchanges between me, Vic, and Biogen).

Subsequent e-mail (paraphrased) that I received from Vic:

Lauren,

I do not know who you called or what you did, but THANK YOU !!!!

I see my neurologist on November 3 and will be back onTysabri on November 4 !!!

Some way or another there seems to have been a deal negotiated between Biogen, Elan, Anthem Blue Cross and the infusion center to make this all work out in a fair manner.

Thanks again for all of your help !!! -Vic

Additional e-mail exchange (paraphrased) that I received from Vic:

Thanks again, Lauren!

My neurologists are both thrilled by this, and the amazing thing is that I was notified by Biogen that I am already enrolled in the TOUCH program even though I was disenrolled a few weeks ago....Thanks agin. :-) -Vic

E-mail exchange (paraphrased) to Vic after I found out that he was restarting his Tysabri again:

Wonderful Vic! I'm so glad & happy for you!!!

I will let my contact over at Élan know that you are going back on Tysabri when you see your neurologist on November 3rd... woo hoo, all of the thanks go to Élan as they truly worked a miracle!

I have to cut this e-mail short because I need to get my rest before my next Tysabri infusion tomorrow..., againVic, I'm so happy for you..., take care now.

Lauren :)

Subsequent e-mail exchange (paraphrased) between me and Élan:

Good morning XXX (Or good afternoon depending upon where you are),

Thank you for your e-mail, I am glad that I have someone else to turn to besides XXX (the Biogen Patient Services Supervisor) because they could not help Vic the way you did..., at my 27th Tysabri infusion yesterday, my infusion nurse described to me all of the problems they were having with Biogen representatives over at MSActiveSource (i.e., the Tysabri Case Managers). For example, more than
28 days ago, I changed neurologists within the same Medicare HMO (Kaiser Senior Advantage) to a neurologist closer to me that is also Touch Certified, and my Tysabri Case Manager did absolutely nothing to ensure that my future Tysabri infusions remained uninterrupted.

If it had not been for the
daily phone calls that my infusion nurse had to make to MSActiveSource (never once speaking to the same person over there, and never once speaking to my Tysabri Case Manager) making sure that all of the paperwork was completed, signed by both me and the infusion center, etc., including the fact that one day they were told by MSActiveSource that they could not fax anything until 1:00 PM when time was of the essence, so as to not interrupt my infusion schedule) I would have had to reschedule my infusion appointment. None of the paperwork was completed on their end, confirmed, & authorized until 9:00 AM the day of my infusion yesterday which was scheduled at 10:00 a.m.

The lackadaisical attitude of these Tysabri Case Managers over at MSActiveSource is placing Tysabri patients in peril that have their infusions interrupted/ceased.

I am advising you of the above not to complain, but to explain to you that I was already aware that the change in neurologists would take time for confirmation, authorization, etc., but
28 days??? Not hardly..., this should've been completed by my Tysabri Case Manager within a week at the most.

And almost everything that I hear/read on the different MS boards is pretty much like the scenario above, problems galore, and confirms my suspicions that MSActiveSource/their Biogen representatives (Tysabri Case Managers) are not doing what they were hired to do (in my opinion), which is
assist disabled MS patients when it comes to managing their Tysabri therapies and not continuously throwing out roadblocks which inhibit-block and/or postpone their treatments. Most of these MS patients are unable to retain/remember, or have the wherewithal, physical ability, insurance understanding and knowledge to do what needs to be done in order to ensure their therapies remain uninterrupted. This worries me tremendously because I've been dealing with them since 2006....,

Anyway, I apologize for monopolizing your valuable time XXX, but I just wanted to make you aware of what is happening in our "world of MS"..., Enjoy the rest of your week and again, thank you so much for helping these patients!

Lauren

Saturday, October 04, 2008




My Tysabri Diary.....,

I had my 26th Tysabri infusion Wednesday the 1st and all went well, I was just extremely tired when I got home, and just skipped dinner that night and went to bed, and just having a light dinner Thursday night. I had my traditional pizza dinner Friday night.

The weeks prior to this infusion were more hectic for me than usual...., I changed neurologists (I really didn't want to because I had my neurologist for more than seven years), but she had a baby and was cutting back her hours, plus she was 53 miles away from me [and that's just one way], so the Kaiser neurologist near me agreed to take me on as his patient once he evaluated me...he is Touch Certified and after my appointment with him, he authorized another six months of Tysabri for me.

One miracle for me was my vision has dramatically improved to the point where I no longer have to wear my glasses when watching TV... my optic neuritis from my MS is almost completely gone. He was very happy to hear this and a big grin flashed across his face. Even though I will miss my former neurologist, I like this new doctor very much. He is very kind, caring, and really listens to the patient...he actually encourages patient dialogue with him, which I found incredible.

Then I had to go through the hassle of notifying my Tysabri Case Manager, the infusion center, making sure that the appropriate "doctor's orders" were in place, etc...., sheesh!

To make matters worse, the infusion center did not have his Tysabri orders in my file the morning of my infusion, so after I made several important and insistent phone calls, I was able to reschedule my infusion for that afternoon...,

At the end of the day, I was totally wiped out, but my infusion nurse was excited to tell me that they are getting two more Tysabri patients next month, Woooohoooo!

All my best to everyone, take care now...,

((((hugs))))

Love, Lauren :)

Friday, September 19, 2008

My Tysabri Diary...greeeeeaaaaat news just released today!

http://www.elan.com/News/full.asp?ID=1199030

September 2008
TYSABRI® Demonstrates Sustained Improvement in Functional Outcomes in Multiple Sclerosis Patients According to New Post-Hoc Analysis:


TYSABRI is the Only Marketed MS Treatment to Show Both Significant Slowing in Disability Progression and Sustained Improvement in Physical Disability


MONTREAL--(BUSINESS WIRE)--Sept. 19, 2008--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that a post-hoc analysis showed TYSABRI® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing multiple sclerosis (MS). These findings were derived from a subset analysis of the Phase III AFFIRM trial and were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada. This is the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS.

"These results show that TYSABRI treated patients are significantly more likely to experience a sustained improvement in disability compared to placebo patients. This finding from a post-hoc analysis of the pivotal AFFIRM trial supports both the earlier findings from the AFFIRM trial that TYSABRI is associated with an improvement in quality of life as well as anecdotal evidence of recovery of function in some patients." said Frederick E. Munschauer, MD, Smith Professor and Chair, Department of Neurology, State University of New York at Buffalo. "While, like TYSABRI, other therapies have shown a slowing of progression in disability, this analysis represents the first evidence supporting a sustained improvement in function associated with an approved disease modifying therapy."

Post-hoc Disability Analysis of Phase III AFFIRM Study

The proportion of patients exhibiting sustained improvements in physical disability in the AFFIRM study was determined based upon the Expanded Disability Status Scale (EDSS) over two years in patients with relapsing MS. EDSS is one of the oldest and most widely utilized methods of quantifying disability in MS.

Post-hoc analysis of AFFIRM patients assessed sustained improvement in disability among patients with a baseline EDSS score > or = 2.0. Improvement in disability was defined as a one-point decrease in EDSS score sustained for 12 weeks. The cumulative probabilities of 12-week sustained improvement in disability at two years were estimated using the Kaplan-Meier method. Treatment effects were analyzed using the Cox proportional hazards model adjusted for baseline EDSS score. The distribution of sustained improvement by baseline EDSS score for each treatment group was also examined.

TYSABRI produced significant results on the cumulative probability of sustained improvement in disability in those treated over two years compared with placebo. In patients with a baseline EDSS score > or = 2.0, the probability of achieving sustained improvement was 29.6% with TYSABRI (n=417) compared with 18.7% with placebo (n=203) (p=0.006). In patients with an EDSS score > or = 2.0 and highly active disease at baseline, the difference between groups was even greater, 35.5% for TYSABRI (n=103) and 15.4% for placebo (n=40) (p=0.045).

The submitted abstract for this study, entitled "Natalizumab significantly increases the cumulative probability of sustained improvement in physical disability" (ID #P474), is available on the World Congress' website.

About TYSABRI

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)>.

Can we all say "Woooohoooo"? I know I can!


((((hugs))))

Love, Lauren :)

Thursday, September 11, 2008

My Tysabri Diary....., this is also from my acquaintance as opined above:

"As you all probably know, MS usually starts manifesting itself clinically between the ages of 20-40. It rarely kills. Instead it slowly, but inexorably causes more and more culmulative neurological damage and disability. Patients live with the disease for many decades.

Although in a strict scientific sense, one can not compare results from one trial to another, I believe the overwhelming majority of neurologists would opine that Tysabri is more efficacious than any of the CRABS. If one looks at the results of the large phase 3 trials, the interferons produced a reduction in the progression of disability in the range of 33-36%. Copaxone was not able to demonstrate a statisitical significant reduction in the progression of disability. Tysabri showed a reduction in the progression of disability of apprx. 42%. Now this difference between the interferons and Tysabri does not appear that great (at least for 1 year). But try a bit of compounding as it relates to efficacy. Take that 6-9% difference and compound that out 10 , 20, 30, or 50 years. The differences in disability progression are dramatic.

Of course this assumes that the rates in the reduction of the progresiion of disability remain fairly constant. We have 2 year data. And we have 3 year data showing no significant change in rates.

No one is focusing much at this issue because 1) we don't have any certainty if the rates will continue to hold and 2) everyone is still consumed with the risk side of the equation.

Over time however, as the risk profile becomes more defined, and these tens of thousands of patients are followed for longer periods of time, the true magic of compounding should come into focus.

I submit that when neurologists start to compare the neurological results of patients 4-5 years on Tysabri versus 4-5 years on the CRABS, the results will sway more patients and earlier treatment to Tysabri."

I found his opinions very interesting and very rational ..., have a great day everyone.

((((hugs))))

Love, Lauren :)

Tuesday, September 09, 2008

My Tysabri Diary..., updated Tysabri information:

The following opinions were expressed by a very learned acquaintance of mine whose wife is currently on Tysabri (I believe she is on her 26th infusion):


"Yes, we got our first two cases of PML since the re-introduction of Tysabri. And yes, cases in monotherapy, but there are positives here which may in the long run prove very beneficial to the opinions of Tysabri....,


1. Both patients are alive and were diagnosed due to the European surveillance program (remember, they do not follow the Touch program that is in place here in the US).


2. One was diagnosed VERY early and is almost completely recovered, having NEVER been hospitalized.


3. The other patient was diagnosed somewhat LATE, given that the patient presented with symptoms suggestive of PML with an atpical MRI. This patient should NEVER have been given more Tysabri and high dose steriods. Yet despite the above, the patient APPEARS to be making a recovery.


4. Again in a sense, these two cases provide a nice range. One diagnosed very early, one diagnosed rather late. Both are alive and APPEAR to be recovering. Both cases are being actively followed by ALL Tysabri prescribing neurologists, via conference calls by Biogen. Should these patients continue to do well, it will go a long way to changing the risk/reward ratio, IMO. The risk was previously assumed to commonly be death, or at best severe permanent disability.


5. In addition to the neurologists, a great many of the CURRENT Tysabri patients have been told of these cases and the fact that the patients ARE ALIVE and APPEAR to be recovering. This is being done via the neurologists and/or the infusion nurses (and most do not want to come off Tysabri).


6. THUS FAR, there have been no new confirmed cases in the last 5 weeks. ALL of the 17 suspected cases in the database have been resolved to satisfaction.


7. Biogen has re-stated their business plan which still includes 100,000 patients on Tysabri by late 2010. They have stated that their projections have always assumed additional cases of PML. In fact, these cases came later than originally expected.


8. Because the second patient had a prior history of immunsuppession, and may in fact have been immunosuppressed BEFORE starting Tysabri, neuros are going to be even more cautious about checking and monitoring the immune status of potential Tysabri patients.


9. Tysabri is now postioned to be used BEFORE the strong immunosuppressive agents. Since Tysabri's re-introducton, a great deal of patients with prior STRONG immunosuppression (and who were still progressing) have already been exposed to Tysabri. Going FOWARD, I believe there will be fewer of these high risk patients going on Tysabri. Again, most patients progressing on the CRABS will now go to Tysabri PRIOR to the strong immunosuppressants."


I hope that some of the above information will also help calm the fears of current Tysabri uses (not many are afraid of PML), and help calm the fears of prospective Tysabri patients.


((((hugs))))

Love, Lauren :)

Wednesday, September 03, 2008



My Tysabri Diary...,

Hi everyone, I just returned home a little while ago from my 25th Tysabri infusion... once again, no problems, no side effects, no adverse reactions, and no problems with the infusion... my nurse was able to "stick me" with just one jab, yay!

When I asked how the other Tysabri patients were doing, I was told "just fine", no problems there either and no one was concerned about the two new cases of PML in Europe.



So other than that, I have nothing new to report (which is a good thing).

I did want to share an e-mail that I sent to the editor in chief of the AAN recent publication regarding the new guideline that their authors published yesterday (I've received no reply from them as yet, and I really don't expect one either)...., they kind of pi$$ed me off (oops).

I'm off to have an early dinner of pizza and mudslides, and then turn in early... have a wonderful evening everyone,

((((hugs))))

Love, Lauren :)



Subj: AAN's Publication for Use of Natalizumab dated 9/2/08
Date: 9/2/2008 3:22:43 PM Pacific Daylight Time
From: LGLBGL2003
To: editorinchief@aan.com


Gentlepersons,

I just reviewed your publication of the New Guideline Published on the Use of Natalizumab for MS:

http://www.aan.com/news/index.cfm?event=read&article_id=6024&page=72.45.45


From a review of the publication above, strong exception is taking to the following language used:

"
it is recommended that natalizumab be reserved for use in selected patients with relapsing-remitting disease who have failed other therapies either through continued disease activity or medication intolerance, or who have a particularly aggressive initial disease course.".

This recommendation is in direct conflict with the FDA approved Tysabri label and which furthermore is in direct conflict with the FDA memorandum which previously issued, stating in part: "FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommendedfor patients who have had an inadequate response to, or are unable totolerate, alternative multiple sclerosis therapies (e.g., as second-line therapy).
However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-FDA-Errata.pdf
".

In addition, Tysabri is to be used for "relapsing forms" of MS, which include Relapsing-Remitting, Progressive Relapsing, and Secondary Progressive with relapses. The authors of the article indicate that it is for relapsing-remitting disease, which is completely incorrect. The Tysabri 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.".

While I understand that the AAN is a medical specialty group and as such, does not preclude recommending a narrower scope of Tysabri's use, what in fact the AAN authors of this article are doing is condemning a wide variety of MS patients to suffer additional relapses and disease progression needlessly by relegating treatment first with one of the ABCRs, not to mention a very large patient population of noncompliance to the ABCRs treatment regimes due to their side effects and injection site reactions. Furthermore, said language will make it extremely difficult for insurance companies to provide approval for the use of Tysabri in these patients and as a first-line therapy when first-line therapy use is clearly approved by the FDA. The authors of said article should take into consideration that
the health care provider needs to consider its use based on the unique circumstances of each patient.

Your authors begin by commenting: "
Strong evidence suggests that natalizumab reduces disease activity and severity in people with relapsing MS by both clinical and MRI measures."..., would it not behoove MS patients to begin treatment as soon as possible with Tysabri in order to achieve these results?

Lastly, your authors state that: "
strong evidence suggests an increased risk of developing PML in patients receiving combination therapy with interferon (IFN) and natalizumab"..., considering Tysabri can only be prescribed as a monotherapy to non-immunocompromised MS patients pursuant to the FDA approved label and accompanying RiskMAP, there is no increased risk of developing PML.

As a Tysabri patient for more than two years and a MS patient for more than 32 years, I really must object to the language used by your authors in this publication, and respectfully request a clarified and corrected publication issue which will help truthfully guide physicians when treating their MS patients rather than mislead them into allowing their MS patients to continue suffering possible permanent damage needlessly due to the AAN's authors current language.

I look forward to your prompt reply.

Respectfully submitted,

Lauren Roberts





Monday, August 25, 2008




Good news regarding Tysabri, woo hoo!

This is wonderful news Re: those who are concerned about developing PML with the use of Tysabri..., let me briefly explain what my neurologist told me about PML: PML occurs when the immune system has been compromised (or becomes so low that it cannot fight off the JC virus which causes PML to occur)... Plasma Exchange or Plasmapheresis helps to rapidly remove Tysabri from the body, thereby reconstituting (or making strong again) the immune system..., I hope that the following information helps calm the fears of those who are afraid of Tysabri(a.k.a. Natalizumab)....,

Here is the article:

Plasma Exchange Accelerates Natalizumab Clearance
http://www.neura.net/channels/1.asp?id=907

Robert Fox, MD, Cleveland Clinic Foundation, Cleveland, Ohio, reported results of studies that showed that plasma exchange (PLEX) accelerates the clearance of natalizumab, an anti-alpha 4-integrin monoclonal antibody, and restores leukocyte migration into the central nervous system, thereby potentially improving the clinical outcome of patients who have suspected or confirmed cases of progressive multifocal leukoencephalopathy (PML).

The risk of PML, an opportunistic viral infection of the brain, is increased with natalizumab treatment, and, Dr. Fox noted, immune reconstitution is currently the only effective intervention for improving outcomes in patients with PML. In one study, 12 patients with MS who had received at least 3 monthly infusions with natalizumab 300 mg received three 1.5-volume exchanges, over 5 or 8 days, performed 10 to 14 days following their last natalizumab infusion. Mean serum natalizumab concentrations, monitored throughout the PLEX course, were reduced >95% from baseline immediately following PLEX, Dr. Fox reported, and natalizumab clearance was accelerated by 75 days compared with natural decline.

In a second study, performed in a subset of 6 of 12 patients, peripheral blood mononuclear cells (PBMCs) were assessed for chemokine CCL2-induced migration using an in vitro blood-brain barrier (ivBBB) model during natalizumab treatment and following PLEX. PBMC migration across the ivBBB was shown to increase by 2.2 fold after PLEX.

Based on the results of these studies, Dr. Fox noted that PLEX offers potential for immune reconstitution in potential PML cases associated with natalizumab treatment.

((((hugs))))

Love, Lauren :)

Monday, August 18, 2008


My Tysabri Diary...PML is no longer the "Kiss of Death"

An acquaintance of mine just posted this on a blog:

"
Treatment of PML

I received this late last week from a prominent University MS clinic.

"Friends: I share this information, received from an investment analyst who says he spoke to the German researcher handling the German PML case:


1. The other case - in Sweden - has practically resolved all PML related symptoms 2. The German case has been treated with mefloquine (http://tinyurl.com/Mefloquine) in the last week. All cognitive complaints have resolved since it was initiated, and he is hopeful that all motor signs will resolve as well.


If this is true in both cases, the prognosis for the PML evidencing in a small number of Tysabri treated patients is not a monolithic, tragic kiss of death, but a spectrum of outcomes with the potential for significant recovery."

He goes on to state, "
The concept of PML as a treatable disease is emerging."... we can only and pray that this is the case.

While there is still no illuminating information about the patient's past medical history (the patient in Sweden-case #1), the fact that both patients appear to be doing well, it's very good news indeed!

Just thought I would pass this information on to everyone that is interested.

I almost forgot to mention that I received the an e-mail from Tysabri.com, reminding me of the Peer-To-Peer Teleconferences that are scheduled, you may want to make a note of the following dates and times:

August 18th at 8 PM ET
August 21st at 7 PM ET
August 25th at 8 PM ET
August 28th at 10 PM ET
September 4th at 7 PM ET

The e-mail goes on to state in part: "
The panelists will be participating in an open dialogue about how MS has affected their lives and the difference TYSABRI has made for them.

To participate, call 1-866-644-8540 at least 10 minutes before the start of the teleconference. When asked for a code, please say "Peer to Peer Teleconference."

To learn more about upcoming programs, please visit www.TYSABRI.com or call Patient Services at 1-800-456-2255."

***
Have a wonderful rest of the week..., I send you all my very best,

((((hugs))))

Love, Lauren :)

Wednesday, August 06, 2008



My Tysabri Diary...

I just returned home a little while ago from my 24th Tysabri infusion... nothing new to report other than there was a terrible accident coming home from the infusion center, and having to sit quite awhile in traffic pretty much wiped me out. So I'm going to go to bed early tonight after Ray (my caregiver) returns with the pizza (I'm already sipping my mudslide, yaaay!) <---- laughing.

I asked my infusion nurse if there had been any changes in the number of Tysabri patients they were infusing, if any had dropped out, or if they had added anymore... she said that everything was "status quo", and that all of the patients were doing very well on Tysabri and had absolutely no complaints about the medication (remember, this is a very small infusion center)... she did tell me that she noticed my MS has been stable since I've been going there to receive my Tysabri infusions, so this is a good sign :)

I haven't really checked many of my e-mails because I am really superduper tired, but happy and pleased that I still experience zero side effects from this medication. I can only hope and pray that other patients are loving Tysabri as much as I am.

I am also please to hear that most MS patients & neurologists are not swayed at all by the recent PML reports in the two European Union patients..., it is my understanding that Biogen/Élan (the manufacturer/distributor of Tysabri) is holding approximately 20 different Neurologist Conference Calls through the end of Friday this week to update them regarding the situation, and answer any questions that they might have. I am also please the most of these neurologists (I hear) have not changed their minds at all about Tysabri, and they are still very excited about Tysabri's prospects for their MS patients in need, while they are becoming very aware of the need to continue in their vigilance of observing their patients and monitoring them closely... I don't ever remember my neurologist closely monitoring me when I was on Avonex & then Copaxone... I like being monitored closely, it makes me feel not only safe, but closer to my neurologist :)

Have a great evening everyone,


((((hugs))))

Love, Lauren :)

Saturday, August 02, 2008



My Tysabri Diary...time for everyone to calm down and take a deep breath...
Damage Control..., I have been receiving e-mails left and right from MS patients currently on Tysabri therapy about the two new cases of PML which were just reported by Biogen/Élan. This news of the two new cases of PML have already hit the MS boards... I'm trying to keep everyone calm until all relevant facts have been disclosed by the companies... it is noteworthy to know that these two patients are not in the US, they are in the European Union where they do not have the Touch protocol... both patients are alive, and one is already home and still ambulatory.

Tysabri is still my drug of choice to treat my MS.

The full details of these two patients prior histories has not been as yet released (i.e., were they already immune compromised before starting Tysabri therapy?)... therefore I would caution everyone to not panic and not read too much into this news until all the facts are known... from what I have been reading, most neurologists are not terribly concerned about these two cases, and the vigilance of the neurologists in the EU has to be extraordinary, considering they don't have the Touch program..., of course, some Tysabri patients will request that go off the therapy as this news is beyond their comfort level for risk vs. benefits, but the majority of MS Tysabri patients will remain intact, with still more MS patients being added weekly:

Read the news for yourself, this is from the FDA's archive files:

http://tinyurl.com/55sfod

On July 31, 2008, Biogen Idec Inc. and Elan Corporation, plc notified relevant regulatory agencies of two confirmed cases of progressive multifocal leukoencephalopathy (PML) in multiple sclerosis (MS) patients treated with TYSABRI® in the commercial setting. Additional information about these cases is set forth below.

Case 1

· On July 30, 2008, following a period of clinical evaluation, Biogen Idec received confirmation of a diagnosis of PML in an MS patient in the European Union (EU).

· The diagnosis was made based upon the detection of JC Virus (JCV) DNA in the cerebrospinal fluid (CSF) in the setting of clinical signs, symptoms and magnetic resonance imaging (MRI) findings consistent with the diagnosis of PML.

· As reported to the company on July 31, 2008, the patient remains clinically stable and ambulatory at home.

· Background:

- Patient in EU with aggressive MS who was naïve to prior disease modifying therapy;

- TYSABRI monotherapy for approximately 17 months;

- Clinical vigilance led to early identification of signs and symptoms of possible PML and medical work-up which included MRI scanning and CSF testing, but PML was not confirmed at that time;

- However, given continued clinical suspicion by treating physician, plasma exchange was initiated as outpatient;

- Subsequent testing of CSF detected JCV DNA, which was reported to the company on July 30, 2008;

- It was then determined by PML experts that the latest CSF results, together with the clinical history, physical findings, and MRI results, are consistent with the diagnosis of PML.

Case 2

· On July 31, 2008, Biogen Idec was notified of a diagnosis of PML in a second MS patient in the EU.

· The diagnosis was made based upon the detection of JCV DNA in the CSF in the setting of clinical signs, symptoms, and MRI findings consistent with the diagnosis of PML.

· As reported to the company on July 31, 2008, the patient is currently hospitalized.

· Background:

- Patient in EU with MS with a history of prior disease modifying therapies including azathioprine and beta-interferons;

- TYSABRI monotherapy for approximately 14 months;

- Evaluation for possible PML, included MRI scanning and CSF testing;

- CSF testing detected JCV DNA, which was reported to the company on July 31, 2008;

- The CSF results, together with the clinical history, physical findings, and MRI results, are consistent with the diagnosis of PML.

***
In closing, let me say that I only hope that some of the above information does help to relieve some of the fears that have been circulating… honestly, IMHO not enough is known about these two patients prior medical histories that would make them susceptible to developing PML. In addition, plasmapheresis has been used on one patient to remove Tysabri from the body, and the other patient is currently receiving plasmapheresis therapy, even though he’s in the hospital.

It is also my hope that those two patients make a full recovery as the due diligence of their neurologists paid off in that they both caught these two cases in early.

((((hugs))))

Love, Lauren :)

Friday, July 11, 2008



My Tysabri Diary...

A very happy belated Fourth of July wish for all of you, I hope your holiday was safe and filled with good food (heehee). I made my famous barbecued chicken wings recipe, no-mayonnaise potato salad (the potatoes are parboiled and then grilled for a smoky flavor, mixed with grilled onions, bacon, blue cheese dressing and balsamic vinegar), and then I made my delicious carrot & raisin salad...., oh my goodness, everyone stuffed their faces...soooooooo yummy!

As I watched the spectacular fireworks display out here, I couldn't help but remember my MS friends who were never able to see the fireworks on Friday the 4th because they had lost their vision (or a majority of their vision) due to their MS. Because of this, I wanted to post the following link on my blog which is a short 3 1/2 minute video that explains How Tysabri Works. I thought it was fitting considering that not only does Tysabri prevent worsening of vision loss in patients with relapsing MS, Tysabri is also associated with significant reductions in the likelihood of sustained vision loss.

How Tysabri Works:

http://tinyurl.com/How-Tysabri-Works

So, on to better subjects...here is my 23rd Tysabri infusion report: I had my 23rd Tysabri infusion on Wednesday, 7/9... all went well, no problems, no surprises, and no terrible multiple "sticks"... one stick and my regular infusion nurse had a line in. I asked my infusion nurse how the other Tysabri patients in our small infusion center were doing, and she said they are all doing very well. So I really have nothing new to report.

In the interim, someone asked me a question regarding a friend of theirs that was recently diagnosed with MS, and their neurologist placed him on Avonex, which his friend really didn't want to go on, so he asked me this question: "Can my friend go directly onto Tysabri as a first line therapy? Or does he have to fail on a CRAB first? I just don't know what the TOUCH protocol is"..., my answer is yes, he can go directly onto Tysabri as a first-line therapy IF his neurologist recommends it (which obviously, his neurologist doesn't); there is also the issue of whether or not the patient's insurance would question Tysabri as first-line therapy, and the neurologist really has to convince the insurance company that 1) the patient cannot tolerate the other therapies [the patient is needle phobic], or 2) the patient has a highly aggressive form of MS and the neurologist does not want to wait and try the other ABCRs first.

The FDA clarified their response to Tysabri's use as a first-line and/or second-line therapy for MS...see:

http://tinyurl.com/FDA-Memorandum

Clarification article by the FDA regarding Tysabri's use as a first-line AND/OR second-line therapy for MS patients

First-line Tysabri therapy in some MS patients

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH


SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007
In the reviews, Tab 1 (FDA Clinical Review) and Tab 2 (Office of Surveillance and Epidemiology Review), it was stated that the MS population to receive Tysabri should be those “unable to tolerate or with an inadequate response to other available MS therapies” and it was stated that the indication was revised to “relegate it [Tysabri] to a second-line therapy for relapsing-remitting MS.” The indication in the current label states “…Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies.”

FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is
generally recommended for patients who have had an inadequate response to, or are unable totolerate [i.e., needle phobic patients] alternative multiple sclerosis therapies (e.g., as second-line therapy).

However, the indication statement
does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.

So as you can see, it really depends on the neurologists' recommendation. If the newly diagnosed MS patient feels that a second opinion is in order (I mean really, Avonex is a once a week shot into the muscle and is only 32% effective at preventing further relapses/slowing the disease process down with horrible flulike side effects, whereas Tysabri is 67% effective with only minimal to no side effects for most of the MS patients, has proven data showing an 83% reduction in the accumulation of new or enlarging lesions over two years, as well as 92% fewer lesions during Tysabri therapy after both one and two years)..., he should contact MSActiveSource at 1-800-456-2255 and request three names and numbers of Touch certified neurologists near him so that he can make an appointment with one of them...he only needs to provide his ZIP code to them.

I hope that this information was of some help to that new MS patient. I also told him that if he decides to go with Avonex first, I suggested that he take a liquid Advil approximately 20 minutes before the shot, and ice the injection site (place an ice cube wrapped in a washcloth) for approximately 5 minutes before the injection as this will help with the pain of the needle going into the muscle...and I also suggested that he do his shot just before he goes to bed (hopefully he can sleep through the majority of its flulike side effects) and has the next couple of days to recuperate from its side effects. And I also reminded him that I was not a doctor, the above is only my opinion, with the exception of the proven Tysabri data that I mentioned (proven data is not my opinion, it is fact).

I was pretty tired Wednesday after my infusion so I ate a small dinner of pizza & pasta, accompanied by a mudslide or two, and then turned in.

I have a ton of new e-mails that I need to answer, and I hope to respond to some of your comments left recently on my blog... until then, have a wonderful weekend everyone.

((((hugs))))

Love, Lauren :)

Wednesday, June 11, 2008




My Tysabri Diary...,

Hi everyone,

I returned home a little while ago from my 22nd Tysabri infusion. They [ the small infusion center that I go to now]were really superduper busy, and I'm not sure why. There was a new nurse at the infusion center which decided she was going to "practice" her stabbing techniques on me when she was trying to insert the needle into my arm (where my largest veins are, on the inside of my elbow). After her third jab into my arm, I started crying as it really hurt, and screamed "Please stop!" I guess that kind of pissed her off (or embarrassed her as the some of the other patients there were watching her), but at that point, I really didn't care.

My regular infusion nurse came over and said, "It's okay Lauren, I'll get you all set up". And with one jab into my arm near my wrist, she was in, and then it was my normal infusion routine.

Everything went fine after that point, no problems. I'm going to keep this very short because I am not feeling all that well at the moment (this has nothing to do with Tysabri or the infusion). I had a slight accident yesterday when I fell out of my chair trying to pick up something off the floor, and the shinbone of my left leg landed on the foot pedal of my chair (which is really hard, like a cast-iron skillet) and it took the full force of my body weight when I landed on it. To make matters worse, I hit my head on the wall at the same time...., (I guess I should be grateful that I didn't break my kneecap).

So I'm going to have some pizza and a mudslide or two (maybe three or four) LOL, and just turn in for the night so that I can rest my leg (which is battered and bruised... you know what it's like when you get a HUGE bruise showing after about a minute following an injury)... sigh...for a split second, it reminded me of a couple of injuries I sustained when playing baseball for two different AAA baseball teams at the same time (all pre-MS symptomatology, of course - 1974 through 1975, I think?). Too bad that memory didn't last very long, oh well... such is life, I just keep moving forward, and try not to dwell on the past... I just forge on as I always do... boring, eh?

Have a great rest of the week everyone, bye for now...,

((((hugs)))) Love, Lauren :)

Wednesday, May 14, 2008



My Tysabri Diary...
Hi everyone,

I just returned home a little while ago from my 21st Tysabri infusion... everything went well, no problems at all.

My infusion nurse told me that she went to a four-day seminar that was held by The Infusion Nurses Society, where Biogen presented more information to them about Tysabri, and the Biogen representatives spoke highly of Tysabri's efficacy and the great results that many MS patients are experiencing, etc....the only thing that bothered me was that she said the Biogen representatives presented Tysabri as a "second line therapy" and that it works great when other treatments have failed... grrrrrr. She also mentioned that they were going online with part of the Touch procedures, but she could not remember everything that the representatives presented regarding this aspect presented.

When I got home, I called MSActiveSource (1-800-456-2255) and spoke to a Touch Case Manager and he told me the following:

The aspects of going online for part of the Touch program were mainly to cut down on the paperwork required regarding the infusion center nurses' checklist (they used to have to fax the checklist over to Biogen) , for better communications between the infusion center and Biogen, to go over any PML questions/concerns (i.e. keep an open line of communication with the infusion center), to track the Lot Numbers of the vials (which will help Biogen/Élan better calculate how many patients are currently on Tysabri therapy), check the authorization dates for infusing Tysabri, etc. He further told me that there were not many infusion centers currently involved in going online, as they [the infusion centers] have been unaware of same until recently (that seemed rather odd to me, and I questioned him about that, but he told me that he didn't have any further information on the subject).

My infusion nurse did mention to me that a special code will be given to the infusion centers, the prescribing neurologists, and the patient so that they could access said information (which I think she said will be the date patient was last infused, their infusion schedule, etc.).

Sorry that I don't have any more specific information, but my infusion nurse couldn't remember everything from the four-day seminar, and the Tysabri Case Manager only gave me the generalizations above. So all in all, it was a good day.

Ray (my caregiver) and just arrived with pizza and mudslides, so I'm off for a quick dinner, my PT exercises, and hitting the hay early because I am a little fatigued (which is normal right after my infusions)...., my friend Chuck (who surprised me with Noël last December) is coming by tomorrow for a visit, and it will be wonderful to see him again.

Have a great evening everyone, all my best to you...,


((((hugs))))


Love, Lauren :)

Thursday, April 17, 2008



My Tysabri Diary...

Hi everyone, yesterday I returned home from my 20th Tysabri infusion (everything went fine of course). The first thing I did when I got online was to check my e-mails, and I had so many wonderful responses to a post that I made last night on a MS board/forum (I just posted the Élan press release from Monday regarding the data presented at the AAN-see additional links below)...

Most MS patients were absolutely thrilled to hear that there were approximately 26,000 patients on Tysabri therapy, no new cases of PML reported since Tysabri's reintroduction to 2006, and the "Disease-Free MS patients on Tysabri therapy" language in their press release, that WOWED a lot of them.

Just prior to my leaving for my infusion, I received a call from my neurologist that had the results of my recent MRIs taken just a couple of weeks ago (these were MRIs of my brai and cervical area, both with and without gadolinium dye).

MRI results: (I am paraphrasing here because I do not remember my doctor's exact words) She told me that she had my current MRI results in (she did not have the actual film, but she was reading from the report which was generated by the interpretation of the MRI results)...

She said said that the good news was I did not have any new lesions
from my recent MRIs which was compared to my Tysabri prerequisite MRI results taken just before I started Tysabri in October, 2006. Further, they were compared to my MRI results taken in mid-2005 which showed the two lesions (one on the right side of my brain and one in my cervical area), i.e., the ones that put me in this wheelchair & caused my hands to start curling when Tysabri was removed from the market) were not enhanced, that was a tremendous relief to me. Therefore, I have no active disease process going on when it comes to new relapses.

Some of the bad news was that my cervical area showed some atrophy (closing/shrinking of the spinal cord near the neck area), arthritic changes, and some early osteoporosis (mainly due to all of the steroids I've had over the years); and some brain atrophy as well. She reminded me that because I have had MS for 32 plus years, this is not unusual (disease progression), and as a matter of fact,
I should be bedridden and I am not! She attributes this (and so do I) to Tysabri slowing the disease process down!

She did say that
she was quite pleased and very upbeat regarding the findings of the MRI results, and definitely wants me to continue with my Tysabri therapy as obviously it is helping me tremendously, and this is not even mentioning the fact that Tysabri is reducing any probable additional costs which would have been incurred with hospitalizations, steroid use, etc.

This left me feeling both joyous and kind of sad at the same time, knowing that this medication is not only helping me, but it is helping others... and yet, if I had not had that severe relapse when Biogen took Tysabri off the market for over 18 months (which left me with two lesions in very critical areas of my brain and my cervical area), I might not be in the shape I am today... but I choose to dwell on the good news, and not the bad news because I can't change the past. I can rejoice that Tysabri is doing precisely what it was designed to do: "delay the accumulation of physical disability and reduce the frequency of clinical exacerbations."

And I get the added bonus of Tysabri slowing down my disease process!

Now here is the exciting news that is being released at the American Academy of Neurology this week going on in Chicago... is it any wonder that 26,000 patients are currently on Tysabri therapy? I highly suspect that many more MS patients are going to choose Tysabri as their choice of MS medication and stay with it until a cure is found for MS:

Biogen Idec and Elan Present New TYSABRI® Data at the 60th Annual Meeting of the American Academy of Neurology
  • Approximately 26,000 Patients on Commercial and Clinical Therapy Worldwide
  • Additional Analyses Show TYSABRI Significantly Increased the Proportion of Multiple Sclerosis (MS) Patients Who are Considered Disease Free for Over Two Years
These data suggest that neurologists and patients are increasingly choosing TYSABRI for the treatment of their disease. The significant clinical benefits are established and TYSABRI continues to offer the potential for compelling efficacy and hope for those patients living with MS," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.

Positive outcomes for patients continue to support TYSABRI's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world. We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive TYSABRI treatment in the U.S.," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.

The full article can be found at: http://www.elan.com/News/full.asp?ID=1129853

Also, just released yesterday was the following:

16 April 2008

Data Presented at the 60th Annual Meeting of the American Academy of Neurology Offers Additional Support for Plasma Exchange as a Potential Tool to Accelerate TYSABRI® Removal

The full article can be found at: http://www.elan.com/News/full.asp?ID=1130827

It is my understanding that all new data is being released about Tysabri this week at the AAN conference, and when more is being released, I will try to have it posted here.

It is way past my dinner time now, so I will try to post more information tomorrow. Have a great evening everyone!


((((hugs))))
Love, Lauren :)

PS: My friend Chuck dropped by today and we had a very nice visit, he brought Noël some goodies (a bunch of busyballs & little mice-stuffed of course) to play with, trimmed all of her nails, even surprised me with a box of chocolate covered cherries, my favorites! Life is good - :)

Wednesday, March 19, 2008


My Tysabri Diary...

Hi everyone...I just finished my 19th Tysabri infusion and everything went fine. Even had my blood drawn afterwards to check my liver function enzymes which I have done every six months pursuant to my neurologist's instructions. I even have a six-month follow-up appointment with my neurologist tomorrow.

One of the infusion nurses at my infusion site mentioned to me that her sister is being tested for MS, and so far, it's looking like she's going to receive a confirmed diagnosis of MS very soon. She asked me many questions about Tysabri, and I gave her whatever information I had, as well as my opinions about Tysabri, and suggested that her sister discuss Tysabri with her neurologist...Time is Brain.


When I got home, I checked my messages and here is one from a sweet young lady who is inquisitive about Tysabri (I post this in the hopes that she understands many people have questions of me about Tysabri, and I did not post her name nor e-mail address to protect her identity, just remember everyone, we are not alone with our MS):

(paraphrasing)

hi lauren my name is xxxxxx and i was dio. in1995 at the time we were wanting to have a baby so no meds plus we didnt have any health insurance. in 2000 i had an exerbation that took my right side and with therapy for 2 weeks (which i hated) i was able to regain my life with only a limp. 2003 i had another on and i havent came back yet i had therapy but i lost it i walk holding onto evefrything but outside my house im in a wheelchair i was on avenox for 1 year but the side effects i could not handle so have been on copaxone since august of 2007 the first week i felt my feet they wernt numb to i really got exctied thinking it was gonna help me get my life back BUT all i can tell now is that i havent had any more relapes and i feel like im ganing weight. i have a friend thats gonna start trysbi was just wanting an other opinion she thinks i should try it. im also taking low dose naltroxne it makes me not so tired but not a lot else. please i need some input.i have 2 young children my boy is 8 and he pushes me in wheelchair i ahte that. sorry about my typing wanting to make a friend who understands xxxxx

(my reply to her)

Hi xxxxx! Thank you so much for your e-mail, sorry for the late reply, but I just got back from my 19th Tysabri infusion and I'm a little tired. I absolutely hated Avonex, I just could not handle the side effects. I failed Copaxone is that it never stopped any of my relapses.

I then went on Tysabri in early 2005, and boy oh boy, what a miracle drug that turned out to be! I had put away my walker and my cane, my slurred speech was gone, my optic neuritis was gone, my limp was gone, and my right drop foot was also gone. My balance was just starting to come back, but it was not back fully with just that one infusion (all of those improvements I had in early 2005 happened within two weeks of my first infusion!).


Tysabri was then removed from the market when I was due for my second infusion in February 2005, and in mid-June, 2005 I suffered a massive relapse which landed me in a wheelchair. Until Tysabri returned to the market in July 2006, I was having a relapse almost every month (and that lasted over year). I even tried LDN too for about six months, waiting for Tysabri's return its market... it did help initially for about two months, but that stopped working for me.

When I restarted Tysabri in October 2006, I have not had relapse nor any disease progression since that time, and that has been 17 1/2 months! I still hold on to the hope that one day I will walk again, but even if I don't, my quality of life is still 100% better than it was without Tysabri.


You asked for my opinion, so here it is: you and your friend should start Tysabri therapy as soon as possible so that your respective disabilities do not become permanent. Enjoy the benefits of Tysabri while you can, don't wait... Time Is Brain... who's brain? Your brain!


In my book, Tysabri = Hope... Hope for a better future, not just for me, but hope for anyone on Tysabri. You have young children, they need you, and you need them. Here is a link that you need to read about Tysabri (it is a Tysabri Brochure) that will help explain the medication to you: http://yedi.com/elan/Tysabri_Booklet_08_2007.pdf

I will be here if you need me xxxxx, so please don't ever hesitate to contact me in the future and I will help you as best I can, even if it is only to listen to a friend...no worries xxxxx, think positive and remain hopeful.

All my best,
Lauren :)

It is dinnertime here, and I'm getting ready to have my regular treats: pizza and mudslides, then I'm off to bed after I do my physical therapy exercises. Life is good...,

I hope everyone is well, and stays well.

((((hugs))))
Love, Lauren :)

Thursday, March 06, 2008



My Tysabri Diary...

Hi everyone, I hope you are all doing well. I've been superduper busy lately, so I'll try to bring you all up to date a little bit with my activities (boring, huh?).

I received an e-mail from a Dr. Schwartz at Healthmeida, Inc., which is a behavioral science company hired by Biogen to create additional patient support services for Tysabri patients. In that regard, they sent me a questionnaire about Tysabri to complete and return to them (Healthmedia), and this was the survey (it was completely anonymous and did not request any personal information):

1. Use the scale below to rate your level of agreement with the following statements. 0 = Strongly Disagree 1 2 3 4 5 = Strongly Agree

It is easy to arrange my schedule to get my monthly infusion.
I am satisfied with the infusion site and staff I visit for my monthly infusion.

Prior to starting Tysabri, I had been feeling sad and not very hopeful about my future.
In the past month, I have been feeling sad and not very hopeful about my future.
Taking Tysabri gives me hope for a fuller, healthier life.
The risks associated with Tysabri are outweighed by the benefits.
I am comfortable talking to my doctor and nurses about managing my condition.
I am concerned about my ability to pay for Tysabri.
It's important to me to continue using Tysabri.
I am concerned about the potential short-term side effects from Tysabri treatments. (Examples: headache, infusion reaction, fatigue)
I believe Tysabri will be effective in treating my MS.
In taking Tysabri, I anticipate that my MS will go into remission.
In taking Tysabri, I anticipate that my symptoms related to MS will lessen.

In taking Tysabri, I anticipate that my quality of life will improve.

In taking Tysabri, I anticipate that I will be able to keep my MS under control.

2. How satisfied are you with the support you get from your family and friends? Very satisfied Satisfied Somewhat satisfied Not very satisfied Not at all satisfied

3. In general, how do you set goals? Select one.
I set my sights on achieving a huge goal but sometimes become overwhelmed.
I can set manageable goals and know what I need to do to meet them.
I usually don't set a goal and just try to do what I think I should be doing.

4. MS can have an impact on physical as well as mental aspects of functioning. Which of the following best describes that impact on your abilities? Select all that apply.
I have little to no limitations with daily functions.
I am limited in the amount and/or type of work I can do at work.
I am limited with my activities outside the home (ex. shopping).

I am limited with taking care of myself (ex. dressing, bathing).

5. How does this (the above) compare to you before taking Tysabri?
I had more limitations prior to taking Tysabri
I had the same limitations prior to taking Tysabri
I had fewer limitations prior to taking Tysabri

6. Prior to taking Tysabri, how often did you feel stressed? Never Almost never Sometimes Fairly often Very often

7. In the last month, how often have you felt stressed? Never Almost never Sometimes Fairly often Very often

8. Please choose the topics you are most interested in related to MS and Tysabri. Select all that apply.
Side effects
Lifestyle information (nutrition, exercise)
Social support
Stress
Depression
Cognitive function (memory loss, ability to think)
Pacing (Spreading out of activities to keep from doing too much)
How to work with your doctor
Stories from others using Tysabri

Additional information on Tysabri
Information on PML (Progressive multifocal leukoencephalopathy)
Other suggestions (30 character limit)

9. Gender: Male Female

10. Please select your age range: Under 18 18-30 31-45 46-60 61-75 Over 75

I found this questionnaire very interesting... so I contacted the Director of Marketing for Tysabri at Biogen to make sure that they did indeed hire Healthmedia, Inc., or if this was being passed around by one of Tysabri's competitors. I was assured that this was definitely a Biogen Tysabri survey, so I completed and submitted same to Healthmedia. Those of you reading my blog who are currently on Tysabri therapy, and did not receive this questionnaire, I would highly suggest that you contact Dr. Steve Schwartz at the following address and inquire where your Tysabri questionnaire is (I would also suggest that you reference the "Tysabri Survey" in your e-mail to them):

survey@healthmedia.com

The Director of Tysabri Marketing at Biogen also advised me that the Tysabri.com website will soon be updated to provide a more balanced view of Tysabri, and also have "Patient Stories" on there as well... Wooohooo! It's about time and I can hardly wait for them to update the website! As soon as I know the website has been updated, I'll let you all know as well. :)

I have also been answering quite a few Tysabri e-mails, mostly questions from patients that wish to start Tysabri... responding to "over-sensationalistic" media reports, and I was personally invited to join a new MS forum in the UK where the MS community is just starting to finally understand the benefits of Tysabri ( that forum just went online today!).

If any other MS patients would like to join this forum, you can go to: http://www.cre8buzz.com/multiple_sclerosis and click on "Sign Up" on the top bar. Make sure and choose "Multiple Sclerosis" as your Community from the drop down menu, it's 7th down from the top. Once in you can personalize you page. So far, I have received a very warm welcome and you probably will too. :)

Oh-I almost forgot, lastly, I was offered and accepted being made co-owner of an online MS Support Group (I got a snazzy new title for my volunteer work there-whoopie! LOL).

All of the above activities are in addition to my visiting the different MS blogs/forums online and helping MS patients there, if I can, and providing accurate Tysabri information to them..So as you can see, I've been pretty busy lately (just a little-Ha!).

Take care everyone, and all my best to each of you.

(((hugs)))

Love, Lauren :)

Wednesday, February 20, 2008


My Tysabri Diary...

I had 18th Tysabri infusion today (why is it that each of my Tysabri infusions lately have been when it's pouring rain outside? Oh yeah, it's winter- heehee)..

I learned that my small infusion center currently has 10 Tysabri patients that they are infusing, and to the best of the nurses' recollections, none of them have had a relapse since starting Tysabri.
My infusion, as usual (thank goodness) was uneventful and my wonderful infusion nurse got me on the first try (Lordy, I love it when I don't have it to endure multiple sticks).

But mainly, what I wanted to pass on was that I had the opportunity to speak with a young MS patient and her mother that had stopped by the infusion center to say hi to everyone as they were on their way for the young girl to have her six-month neuro appointment. When the young girl and her mother found out that I was there having my 18th Tysabri infusion, they asked the infusion nurses if I could possibly speak with them for a while (this is the young girl that I previously told all of you about that had two (I think) previous Tysabri infusions and was feeling kind of depressed as she had not seen any improvements in her condition-that was when I asked my infusion nurse to pass on a message of hope to her when she saw her next).

The young girl (I believe she said that she was only 19) was very shy, but her mother wasn't. Her mother told me that even though her daughter had been diagnosed with MS at age 16, had tried all of the ABCRs, with the exception of Rebif, just continued to get worse and ultimately, wound up in a wheelchair two years ago. Her mother also said that her daughter had various symptoms of MS throughout the years, but none of them had made the connection that it was MS, until she got the final diagnosis (this is very common among MS patients as they look back prior to their diagnosis and can see the various symptoms that they were trying to attribute to other circumstances).


Are you ready for this? Her mother told me that her daughter is now able to take six steps with a walker, and is determined to get her driver's license! Also, her tremors have all but disappeared, and the strength is returning to her hands where she can almost write her name again. Just her balance has not made any improvement, yet. They are both ecstatic about Tysabri, and feel so blessed that they are able to have this medication available to treat her MS.

The young girl told me that she has had no side effects whatsoever from Tysabri, other than a slight headache that lasts the day of her infusion. They told me the name of her neurologist, and I knew who she was (her doctor happens to be my neurologist's partner).
And the best part was the mother told me that two of her daughter's legions on her brain have all but disappeared! Her daughter's face lit up like a light bulb, she was so happy!

I mentioned to them both that because she is still young, her body has a fantastic opportunity to heal itself (with the help of Tysabri keeping most of the inflammatory cells from attacking her central nervous system), and with her positive attitude and future Tysabri infusions, anything can happen! But I reminded them that Tysabri is not a cure for MS...it was designed to try and prevent further relapses and their accumulating disabilities, and to slow the disease process down. What the daughter is experiencing is icing on the cake (improvements). And for some patients (like me), Tysabri is able to keep their MS stable (I have not had a relapse in over a year since restarting Tysabri in October 2006).

I also told them about my experiences with Tysabri after my very first infusion ever in early 2005.
We talked about other things regarding Tysabri/MS/PML/the ABCRs, etc., and just before they left, her mother asked me how long someone can take Tysabri.... I said, "Well, I am on my 18th infusion, and so far so good, so I don't see any reason why your daughter would ever have to stop Tysabri infusions unless she developed neutralizing antibodies to Tysabri, unless she became highly allergic to it, suffered severe side effects from it, or until a superior MS medication came along and/or a cure for MS was found, but I am not a doctor and you should double check with Dr. X.". They both threw their hands up in the air and yelled "Yes! Thank you God!", and then they hugged each other (you would not believe the smile on my face when that happened).

Well, it's time for pizza and mudslides. I hope everyone has a wonderful evening....All my best,


((((hugs))))

Love, Lauren :)

Saturday, February 16, 2008



My Tysabri Diary...

I was not going to address on my blog the negative "melanoma/Tysabri" articles that have been circulating on the Internet, but I have been receiving so many e-mails from other MS patients and also comments on the different MS forums that I visit daily about these articles.

Here is just a small snippet from the responses that I sent to many of the different reporters/articles that were written:

"Your article was very disheartening to say the least because you failed to mention the following and your article does not tell the whole story:

"Might
the drug have caused melanoma in these two MS patients? It's possible", says Timothy K. Vartanian, MD, PhD, chief of the MS division at Beth Israel Deaconess Hospital and associate professor of neurology at Harvard Medical School. Vartanian and colleagues report the two cases in a letter to the Feb. 7 issue of The New England Journal of Medicine.

"The important thing to remember is that Tysabri remains by far the most effective FDA-approved drug for treating relapsing forms of MS" stated Vartanian. "There are adverse effects associated with all medications..."

According to the WebMD article below, both of the women treated by Vartanian and colleagues had existing moles. In fact, one of the women had a family history of melanoma. Her father and a brother had melanomas; both of them remain alive and well.

The report from Vartanian and colleagues does not prove Tysabri caused these patients' melanoma.

The jury is still out, considering there are over 21,000 MS patients currently on Tysabri therapy, and I am one of them, having had 17 Tysabri infusions so far, with not one single relapse nor any disease progression in over a year".

Any MS patient with a history of melanoma in their family should discuss this with their neurologist. They should regularly be evaluated by a dermatologist if they have any mole on their skin and are on Tysabri therapy. These are only my opinions of course, and I am not a doctor. Here is an article from WebMD that addresses these issues in an unbiased manner:

http://tinyurl.com/2lu4s6

Did these articles scare me at all? Heck no! All MS patients have to do is have as much knowledge about Tysabri as possible (and discuss your concerns/questions with your neurologist) in order to fend off these types of "sensationalistic" headlines that precede these biased and slanted media stories.

((((hugs))))

Love, Lauren :)

Friday, February 15, 2008



My Tysabri Diary...

Good morning everyone...I hope everyone had a wonderful Valentine's Day yesterday. Here is an incredible e-mail that I received late last night from a friend of mine who is also currently on Tysabri therapy (I have her permission to post same)... note what her neurologist told her and where he is from... it should knock your socks off, and give tremendous hope to all MS patients currently on Tysabri therapy! And to my friend Matt, congratulations on your engagement!

Subj: Long time ....
Date: 2/13/2008 11:03:50 AM Pacific Standard Time
From:
To: LGLBGL2003@aol.com
Sent from the Internet (Details)


Just wanted to let you know that I'm still loving Tysabri (just had my 17th infusion!!)

I had my meeting w/ my neuro @ Hopkins last month after my infusion and had incredible news I thought you'd love to hear....


I told him about getting all the feeling back in my legs and also about my improved balance. Then I told him I was disappointed that my cognitive problems hadn't improved, but I was still hoping.....He listened and smiled.....then he said "Well, you've experienced the first wave of improvement, most people have that after 4-6 months of treatment. What MAY happen next is a second wave of improvement that we're now seeing in patients that have been on Tysabri for 18-24 months. We actually believe that YOUR MYELIN MAY START REGENERATING!!!". I almost fell off the examination table!!! My MRI looks better NOW than it did 2 years ago. Can you believe that????

SO - you and I are DEFINITELY on the right drug!!! I thank my lucky stars every day that I am on this stuff!!!


Have a fantastic day!!! ....Good luck!!!!

Tammy


Is that fantastic or what?!?! I am soooooooooooooo happy for her!

((((hugs to all))))

Love, Lauren :)

Friday, January 25, 2008

My Tysabri Diary...

I just had an interesting telephone conversation with a Team Leader of Biogen/MSActiveSource with regard to Tysabri infusions being scheduled prior to the 28 day interval (every four weeks-the 'recommended' dosage time between infusions per the Tysabri label, see page 3 under Full Prescribing Information
http://tinyurl.com/37psjy) and he told me [paraphrasing] that if the prescribing physician recommends a prescribing interval of 21 days (every three weeks) for the MS patient, this is not a violation of the Touch program, and only needs to be cleared with the 'payor' a.k.a. the insurance company (this might be a big obstacle to overcome).

You can bet your bottom dollar I am going to be contacting my neurologist first thing Monday morning to discuss this with her as usually going into the third week after my infusion, I can feel that Tysabri's benefits have worn off. You can disagree with me all you want, but unless you feel the same way I do, you cannot understand.

If there are other MS patients that are on Tysabri therapy, and they are in the same boat as me (Tysabri wearing off after three weeks), I would strongly suggest that you contact your neurologist and advised them of the above. I am not sure how Kaiser Permanente will react to this news, or how other payors will react, but I'm definitely going to call my neurologist first thing Monday morning and discuss this with her.

I also mentioned in my conversation with him how very disappointing it is to see that Biogen is not even promoting Tysabri's superior efficacy (67%) over Avonex (32%); that MS patients are being kept in the dark regarding the above; Biogen doesn't even have a Tysabri patient story on their website for other MS patients to see; not even anything about Tysabri never having been linked to PML when used as a monotherapy in a MS patient with a strong immune system.

Nothing at all regarding these issues on the Biogen website. All Biogen is doing is promoting an inferior MS medication (Avonex), and promoting Rituxin which has been linked to 24 cases of PML, including two deaths. It's rather disgusting if you ask me.

Good luck to all MS patients!

((((hugs))))
Love, Lauren :)

Wednesday, January 23, 2008



My Tysabri Diary...

I had my 17th Tysabri infusion today, and it went smooth as silk. No problems, no allergic reactions, basically boring (I'm enjoying being bored regarding my infusions-gives me a chance to get all caught up on my court shows like Judge Mathis, Judge Joe Brown, Judge Christina, Judge Millian, etc., heehee). The other lady that I met last month had to reschedule her Tysabri infusion because she was sick. No one else was having Tysabri today, just me. The other two patients that were there were having chemotherapy.

The infusion center was pretty quiet today because it was pouring rain outside. Same thing happened last month, just a lot of rescheduling (although last month it was pretty busy and jammed packed because it was the day after Christmas).

I did learn that two additional Tysabri patients will be going to my infusion center (these are in addition to the other two patients that were added last month), so Tysabri use is picking up.

I'm going to go check my e-mails, and then I am headed off for pizza and mudslides for dinner (Yum!), and then I'm hitting the hay early because I'm pretty tired right now. I'm sure looking forward to tomorrow!

Have a great evening everyone, all my best-

((((hugs))))
Love, Lauren :)

Sunday, January 20, 2008



My Tysabri Diary...

A young MS patient that I have been communicating with (Lauren Parrott-she has been keeping a UTube video diary of her Tysabri experiences), posted a video last night regarding some answers that I gave her (my opinions) to some of the questions that she was asking me. What a total surprise! I can tell that she is feeling pretty good about doing that video as she is helping other MS patients have a little bit better understanding of Tysabri. Comments left have encouraged her tremendously.

She sent me the link for the video, and after viewing it, I wrote back to her telling her what a fantastic job she did.

I did point out one teeny-weeny itsy-bitsy omission that she made, which was corrected by her in a short subsequent video.

When I wrote her, I had indicated the following: "You stated in your video that Tysabri does not cause problems with your organs. I believe I wrote to you that"...Tysabri does not cause problems with organs like steroids do" (kind of a big difference between the two), and I gave you the Tysabri label as a reference (specifically, page 13 that states 'abnormal liver function tests') - which were pretty much equivalent to the placebo percentage, so no real difference there (again, only my opinion). I just don't want anyone thinking that there is no risk whatsoever, because there is always a risk with any drug that a problem could develop in a patient, even when using aspirin. You might want consider correcting that in your next video so as not to mislead other MS patients. (I think I worry too much - laughing at myself)".

I had also mentioned to her that Tysabri was approved by the FDA on January 14, 2008 for moderate to severe Crohn's disease, and she mentioned that in her short subsequent video.

She is such a sweet and delightful young lady with an extremely positive attitude, which will take her far beyond anything that she could ever imagine. I wish her nothing but the best.

If you haven't seen the video yet, she sent me a link for it (you might even leave her an encouraging comment too because she's trying to educate and help other patients [with a little bit of my help and knowledge] by providing them with accurate Tysabri information like I am):

http://youtube.com/watch?v=5h_uCtVsE3k

She also mentioned to me that she received a message from a lady that had MS and was going to start Tysabri therapy as soon as possible, and the young lady had a son that had Crohn's disease so she is going to talk to her son's gastroenterologist about Tysabri. How cool is that ?!?!

All my best,

((((hugs))))
Love, Lauren :)

Friday, January 04, 2008



My Tysabri Diary...,

This e-mail is from my friend Lynn, who is having her 60th Tysabri infusion on the 15th (Yep, you read that right, 60th Tysabri infusion)...I have her permission to post this, and the link within her e-mail from the Mountain Region Advocate Regional Trainer (She Without Arm, He Without Leg) will blow your mind. Anyone that puts limits on themselves should see this video. If you would like to read about these two dancers, scroll down a bit on the page, and their entire story is there.

By not limiting oneself as to what you can accomplish, you will be able to see yourself in a brand-new light, even though you saw yourself "crippled" at one time....You define your dreams, so be brave and dream them.

No limits limits = strength, confidence, beauty, stamina, and hope. Just trying to accomplish a task, is an accomplishment in itself, and if you don't try, you will never know what unbelievable strides and beautiful changes you can make in your life.

What a way to start the new year off! Enjoy, Lauren :)

Subj: Happy New Year!
Date: 1/2/2008 4:32:40 PM Pacific Standard Time
From:
To: LGLBGL2003@AOL.COM
Sent from the Internet (Details)
Dear Lauren,

Thank you so much for your words of encouragement you give to each of us. I love reading your diary and hearing how things are going for you. I had difficulty posting a reply to your latest update so I am just sending you an email. I absolutely loved the song that you referenced by Celine. I love her music. Yes, another year has gone by, but we are still enjoying Tysabri! I go in for my 60th infusion on the 15th. And yes, I can still say that I have not had a single relapse since I began in 04/02 even despite the ups and downs of all those days. I shared with you before about all the many stressful times I had experienced, but I can now add that I have ridden on the back of a Harley Davidson motorcycle for over 200 miles too! And my precious granddaughter will be 9 months old on the 24th.

I loved the recipes you talked about for your Christmas dinner. I would love to get them sometime. And I am so happy that you got a new kitty. I loved the pictures you posted with the words of encouragement that you gave us for this New Year. I can't wait until I read about the one small step that Lauren took, a giant step for the MS community. You are going to walk some day, girl! I just know it. Attitude is such a big part of that and you are always so positive. Life is going to be great in 2008!

Thank you again for all you do and for the wonderful messages that you share with everyone. We are so blessed. I was also blessed by the inspirational ballet that was forwarded to me by the Mountain Region Advocate Regional Trainer. This is awesome. It is found at http://www.flixxy.com/ballet,htm.

Have a wonderful new year! I love you, Lauren.

Lynn

Sunday, December 30, 2007

My Tysabri Diary...For those of us who are happy to have a love affair with life, here is a terrific song by Celine Dion entitled "Another Year Has Gone By"...this video is nice, but the song is awesome (words below), and I would like to add that even though another year has gone by, it is my hope that we continue this love affair with life and all of its challenges through 2008 and beyond. All my very best to all my friends here for a very safe, happy, forward-looking, hopeful, and healthy 2008! Thank you all for being here, for your caring, understanding, your friendship, and for just being you! Happy New Year everyone...Lauren :)

http://www.youtube.com/watch?v=1GCT9rCA0Lg&feature=related

Celine Dion - Another Year Has Gone By

So many 25th's of December
Just as many 4th of July's
And we're still holding it together
It only comes down to you and I

I know that you can still remember
Things we said right from the start
When we said that this could be special
I'm keeping those words deep down in my heart

Another year has gone by
And I'm still the one by your side
After everything that's gone by
There's still no one saying goodbye
Though another year has gone by

I've never been much for occasions
But you never let another birthday go by
Without announcing how much you love me
But the truth was always there
Right there in your eyes

And we're still holding hands when we're walking
Acting like we've only just met
But how can that be - when there's so much history?
I guess that's how true lovers can get

Another year has gone by
And I'm still the one by your side
After everything that's gone by
There's still no one saying goodbye
Though another year has gone by

Another year has gone by
And I'm still the one by your side
After everything that's gone by
There's still no one saying goodbye
Though another year has gone by

And just for fun:
2007 sped by
2007 has sped by
now we need to face the new year
Now, we need to face 2008
there may be risks involved
There may be risks involved
we may need to face road blocks
We may need to face some roadblocks
so stay alert
So stay alert
share time with friends
Share time with friends
jump over obstacles
Jump over obstacles
with care
With care
and caution
And caution
face challenges
Face challenges
remembered to laugh
Remember to laugh
cooperate
Cooperate
discover
Discover
make new friends
Make new friends (yikes!)
above all, be ready for adventure
Above all, be ready for adventure
stick together
Stick together
and you will be able to go far
And we will be able to go far
very far
Very far
well not quite that far
Well, not quite that far.... heehee
always take time to smell the flowers
Always take time to smell the flowers
don't forget to relax and enjoy
Don't forget to relax and enjoy
never forget to let those dearest to you
And never forget to love those dearest to you



animated happy new year glasses of bubbly
Happy new year everyone! (please don't drink and drive)

Wednesday, December 26, 2007



My Tysabri Diary...
Nothing new to report about my 16th Tysabri infusion today, as I stated before, they are becoming pretty routine now (I like that!). No mudslides and pizza tonight as we are having leftovers from Christmas dinner last night (I taught Ray how to make my pineapple baked ham with maraschino cherries, my sweet potato pie with marshmallows, and my broccoli/cheddar cheese casserole). These three recipes are special and I only make them once a year (errrr, Ray made them this year as I can no longer cook). But they are Sooooo good and so rich! I think he is going to teach his wife how to make them now - heehee.

I was a little worried about leaving Noël home alone for the first time since she arrived here... I was contemplating coming home and finding our little Christmas tree tipped over, with all the ornaments broken that Chuck's wife Sheri had so painstakingly selected. But we only arrived home to find Noël sleeping on my bed with her little mouse...soooooo cute! When she saw me, she immediately jumped into my lap, mouse in mouth-LOL.

I did find out that my small infusion center now has four additional Tysabri patients (all added within the last month!). I wonder if they will be able to handle more because the infusions center today was jam packed full of patients.

I also chatted briefly with another Tysabri patient that was there, but she wasn't in a very good mood (I presumed she was having a bad MS day, as it was pretty cold outside and severe weather changes can definitely affect MS symptoms in a majority of most MS patients). She was also disappointed that she hasn't had any improvements after only four infusions.

I told her to never lose hope and that she might start seeing small improvements by her sixth infusion, but they could happen at any time. I told her that even though I was receiving my 16th Tysabri infusion, my MS is now stable and I haven't had a relapse nor any disease progression in over a year. Tysabri is doing exactly what it was designed to do... prevent further relapses and their accumulating disabilities, including slowing/stopping the disease process with superior efficacy of 67%. I also told her that I never lose hope that I will start to see more small improvements, and I hope to walk again one day. Tysabri = Hope.

She definitely seemed to brighten up a bit, but I still pretty much left her alone after that to contemplate what I had told her, but I also told her I would see her next year, same time, same place (that made her smile again), and if she had any questions about Tysabri, I would be happy to try and answer them (cautioning her that I was not a doctor). We exchanged names, and I left... wanting to get home for a quick bite of dinner, and then turn early.

That's all for now, other than I can hardly wait for tomorrow!

I hope everyone had a fantastic Christmas yesterday... woooohoooooo!

Lauren :)

A very
proud member of http://www.MSpatientsforchoice.org/

Monday, December 24, 2007



My Tysabri Diary...Merry Christmas everyone!


I want to mention how many of you have enriched my life by your friendship, caring, generosity, understanding, and knowledge. I have only given you a bird's eye view of what it is like to live with MS, to live with its challenges, and what it is like for some patients who continue to struggle with its debilitating symptoms, who are struggling to obtain a diagnosis, and at the same time, are struggling/trying/learning to become their own patient advocate when it comes to their health.

I believe that you have a better understanding than most people do about MS, and you are also experiencing some of the joys that these patients are having thanks to Tysabri. You have so very much to be proud of, proud of yourself, proud of the changes you have made in others' lives (including my own), with wonderful changes yet to come. I am proud of you, and I am proud to call you my friend. I have been blessed to meet some of you personally, and I hope to meet more of you in the future, God willing.

Here is a message that I would like to pass on to you, and which I try to live my life by when times get tough for me, and which might help you keep your life in perspective as well:

If you woke up this morning with more health than illness, you are more blessed than the million who won't survive the week.
If you have never experienced the danger of battle, the loneliness of imprisonment, the agony of torture or the pangs of starvation, you are ahead of 20 million people around the world.
If you attend a church meeting without fear of harassment, arrest, torture, or death, you are more blessed than almost three billion people in the world.
If you have food in your refrigerator, clothes on your back, a roof over your head and a place to sleep, you are richer than 75% of this world.
If you have money in the bank, in your wallet, and spare changein a dish someplace, you are among the top 8% of the world's wealthy.
If your parents are still married and alive, you are very rare,especially in the United States.
If you hold up your head with a smile on your face and are truly thankful, you are blessed because the majority can, but most do not.
If you can hold someone's hand, hug them or even touch them on the shoulder, you are blessed because you can offer God's healing touch.
If you can read this message, you are more blessed than over two billion people in the world that cannot read anything at all.
You are so blessed in ways you may never even know.

*Whether I have known you for many years or a few, In some ways you have been a part of shaping things I do. And now that Christmas has come, I realize anew, The best gift life can offer is meeting people like you. -Author unknown-*

I have been blessed beyond belief in knowing you...thank you all for coming into my life.

Merry Christmas everyone!

Lauren :)

Sunday, December 16, 2007



My Tysabri Diary...Friday, 12 /14...a kitten update...I found another picture (the one above) that looks like Noël...oh my gosh, she's so adorable!
Chuck stopped by this afternoon for a visit with me and Noël...she was on her best behavior and didn't turn his arms into scratching posts like she did mine (little brat, but I adore her immensely), ...with much patience and gentleness, she even let Chuck trim her nails!

Chuck even showed up wearing a Santa hat carrying a small Christmas tree and ornaments for decorating it (which his wife so graciously and painstakingly selected), and even little presents to go under the tree for Christmas morning!!!

Of course, Noël had to help trim the tree (or untrimm the tree by attacking all of the ornaments that he and my caregiver were hanging). We had such a wonderful visit, and even took more pictures of Noël, which need to be downloaded on my computer. Now she is playing with my headset/microphone, so before she eats it for dinner, I guess I better go spend some "playtime" with her.

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



My Tysabri Diary...Just an update from me (this was Friday, 12/7) The picture above is not an actual photo of my kitten, but it is very much what she looks like (she is a little bit lighter grey), but her facial features look exactly the same as the photo above. Lordy, she's just so cute!


I think I'm settling on the name for my new kitten to be Noël.


Last night (Thursday, 12/6- her first night here) was a trip, Noël never stopped crying until I went to bed, and once she figured out I wasn't going anywhere, she proceeded to try and sleep on my face. No matter how many times I moved her, she would crawl back up and try to lay across my face.

When I was finally able to slowly scooch her down below my neck, she discovered my necklace and then went into attack mode!

Today, she's discovered that she likes riding in my lap when I'm in my powerchair (good grief), and she has finally slept most of the day in my lap between the keyboard (although she does keep an eye on the blinking cursor).

When she finally had her first meal plus fresh water this afternoon, after her surgery yesterday, Ray and I cracked up because she ate and drank like there was no tomorrow! (Goodbye manners and politeness, hello to kibble everywhere).

Now she's on my lap, passed out, wedged inbetween the keyboard and my ribcage..Let's hope she stays that way for awhile so I can get some work done on my computer - heehee.

Here is a song by Celine Dion, that to me epitomizes what Christmas is all about.

(below are the lyrics, this is the live version so you will probably want to turn your speakers way up)

http://www.youtube.com/watch?v=7Jr-2eyRtV4&feature=related

O Holy night, the stars are brightly shining
It is the night of our dear Savior's birth
Long lay the world, in sin and error pining
Till He appeared and the soul felt its worth

A thrill of hope, the weary world rejoices
For yonder breaks, a new and glorious morn
Fall on your knees, O hear the angel voices

O night divine! O night when Christ was born
O night divine! O night O night divine!

Truly He taught us, to love one another
His law is love, and His gospel is peace
Chains shall He break, for the slave is our brother
And in His name, all oppression shall cease

Sweet hymns of joy, in grateful chorus raise we
Let all within us, praise His holy name

Christ is the Lord!

Then ever ever praise we
Noël, Noël

O night, O night divine
Noël, Noël

O night, O night divine
Noël, Noël

O night, O holy night

Happy holidays to all my friends here, and their families (with a very special thank you to Chuck and John).

May each of your holidays be wonderful, and may 2008 be the year that brings you health, wealth and happiness.

I send this on to all of you with all my love. Merry Christmas everyone.

(((hugs)))
Love, Lauren :)
A very proud member of www.MSpatientsforchoice.org
My Tysabri Diary...I got a Christmas kitten!

Apparently, my friends John and Chuck were in cahoots together and decided to rescue a kitten for me, and Chuck delivered a Christmas kitty to me on Thursday 12/6! And he brought all kinds of goodies for her too! She's just so adorable, but she has not shut up or laid down since she arrived!

She is a rescue kitten, and was just spayed that day. The rescue shelter told Chuck that she would be out of it for a couple of days (yeah right-LOL). It is almost like she is on speed! This post is from Thursday night, 12/6.

I haven't thought of a name for her yet as I want to give her a couple of days so that her personality could shine through, and maybe I can work with that. (Although at the moment, the name "firecracker" comes to mind-LOL).

My caregiver Ray is not too thrilled as he is not a cat person. She has been following him around like a little puppy, and it's so cute, although he almost stepped on her twice!

I am hoping that she will settle down in a couple of hours because as it is now, she has been all over my keyboard, stepped on the escape key twice, attacked the flashing cursor three times, knocked over my juice bottle, crawled on top of my head, and took a flying leap off my desk. Of course, Ray is of no help and only wants to watch a basketball game on TV, men!

Right now, I think she might be starting to settle down a bit as she's curled up on my lap with her little paws resting on the mouse, in a little ball, purring her brains out...she definitely is a little love bug as she was all over Chuck and jumping up into my lap and just could not get enough of someone petting her.

Well, I'm off now to see if I can get her to go to sleep with me. Wish me luck!

Chuck took pictures of her and when I get them developed, I'll try to post a picture of her here. She looks like a little gray striped Tiger, but acts like a baby koala bear with razor-sharp claws on methamphetamines - go figure - heehee.

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

Friday, November 30, 2007



My Tysabri Diary...15th Tysabri infusion report
I just woke up from a long nap. I am happy to report that I still have no side effects or infusion site reactions. Even with the cold, rainy, dreary day out here, I was happy to have been headed off for my 15th infusion only a few miles away, rather than fight the rush-hour traffic in the rain going 53 miles one way like I used to have to do. Wooohooo!

The funny thing was, most of the infusion patients (not Tysabri patients of course-ha ha) were canceling and reschedule their appointments due to the rain.

My infusion nurse is so wonderful, she got me on the first stick. Even one of my favorite infusion nurses was there (she had just returned from her vacation) and had pictures galore to share with me which helped pass the time, and before I knew it, it was time for me to leave!

An update on the young girl that was receiving Tysabri and was so disheartened after receiving only one or two (I believe) infusions. My nurse spoke to her mother after I had been there last month and conveyed my message to her. I am even more happy to report that I was advised today that this young girl has perked up quite a bit, and has hope once again... she is even starting to see some minor improvements in her balance and slurred speech. My nurse also stressed to her mother that as I explained to her last time, if Tysabri is able to slow down the disease process and prevent further relapses, then it is doing the job for her daughter. What a wonderful early Christmas present it must be not only for the young patient, but for her family as well.

Ray just now returned with mudslides and pizza, so I'm off now for a late dinner.

Have a wonderful weekend everyone, take care now.

Love, Lauren :)
A very proud member of
http://www.mspatientsforchoice.org/

Sunday, November 18, 2007

My Tysabri Diary...while enjoying your cup of coffee/cappuccino, here are two videos by the Eagles "How Long" (Don Henley, Glenn Frey, Joe Walsh, Timothy Schmit-I think Feldon is in there too)... the song was written by JD Souther.

The first video is a remix (better quality imho), and the second one is a live version performed at the CMA Awards in 2007. Joe W. recently said in an interview that Timothy S. injured his throat pretty badly in a surfing accident, but will be okay) ... Who doesn't like the Eagles? Both videos are pretty awesome, so turn your speakers WAY UP and enjoy on this beautiful Sunday.

Remixed version:
http://www.youtube.com/watch?v=UIcwnlbbL30

Live version at the CMA Awards in 2007:
http://www.youtube.com/watch?v=xcxudMY38ug

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

Friday, November 02, 2007

My Tysabri Diary...I just returned home a little while ago from my 14th Tysabri infusion.

Nothing new really to report about the infusion as they are becoming very routine. Ray (my caregiver) went out to get pizza and mudslides, yum!


I spoke to my infusion nurse about the other Tysabri patient being seen there, and asked how she was doing. She said, "not too well." I asked, "did she have side effects or an adverse infusion reaction?" My nurse said, "No Lauren, she is not doing well with her MS." It turns out, she's in her young 20s, has been in a wheelchair for a couple of years, and has Progressive Relapsing MS with only three infusions so far, and losing hope.

I asked the nurse to tell her the next time she saw her for her Tysabri infusion, "sometimes it could take 4 to 6 Tysabri infusions for the medication to really get a handle on her MS, and if she hasn't had any relapses in those three months, Tysabri is keeping a majority of those nasty inflammation cells from wreaking havoc with her MS. As it is now, Tysabri is also (apparantly) keeping her rapid progression to a slow progression. And because she's still young, she has a good chance that her damage is not permanent and might eventually see improvements in her condition. And I stress this most of all, please, please tell her, never ever give up hope. She is on the best medication available to us to fight our MS!" My infusion nurse lit up like a light bulb and said, "oh I didn't know all of that, I'll be sure and tell the young lady everything you told me!"

As an aside, I was contacted by a gentleman recently (3 nights ago I believe) who informed me that he has just been diagnosed with MS. He gave me permission to post his e-mails that he sent to me, in the hopes that it might help another MS patient viewing my site. I am going to remove his name to keep his identity safe.

Subj: Hi Lauren
Date: 10/30/2007 5:24:20 PM Pacific Daylight Time
From:
To: LGLBGL2003

Hi Lauren,
I just turned 45 today and was told I may have MS. What a bomb on me. I wanted to throw up and was weak in my knees when I stood. One week ago actually Wednesday I woke with kinda funny vision. I thought it must be a migraine. Well I left work because I couldn't see to do my job and I thought maybe a silent migraine. Next day no better, I went to Ophthalmologist, eyes ok. Wrote me a prescription for prism glasses which I didn't fill. Next day no better, I went to Neuro with some work and had blood drawn and emergency MRI no contrast at 3pm. Dr called me 530pm and said not to worry no aneurysm just some inflammation. Well, I go to my appointment today, Tuesday after Friday and he tells me it may be some concern of the plaque build ups on my brain and it may be MS. I haven't had any other symptoms except dizzy spells last year I attributed to my Pro lapse Mitral Valve. No numbness of extremities only double vision. I was told it can hide in optic nerve. What a day I have had. I have been in Elan for over a year now. What a way for my investment to grow. I told the doc I was bumming because I heard the MS treatments are terrible except for Tysabri but it was hard to get on.He said Ty is only for the big guns. I am thinking must I fail and progress in my disease before I get Ty? If only one more year or so before I came down with this. Granted its not positive but I think it must be. I have another MRI tomorrow with contrast to determine the timeline of my plaque. I have spinal tap Thursday for the ultimate diagnosis of MS. I am dreading this. It will be done with fluoroscopy to use the smallest needle. I am concerned that it will take up to 10 days for the diagnosis. I am worried my vision can worsen and maybe I wont have a good recovery in my vision by waiting so long. Do you know about recovery of vision? Could it be Myasthenia Gravis? Spelling is bad. Your write ups on IV are so professional. I could only wish to write like you. I read your letter to the WSJ guy. You really did wonderful. I wrote him too and had a response that was so general. I saved all the sites you sent him on favorites.
Can you help me find a progressive neuro that would write for Tysabri? Isn't that the best to do? I guess my insurance would cover it. Can you direct me to sites that will help me find info that I need to make best decisions and weed thru this? I am scared of being on a bad drug that would just make me worse in complications.
Please tell me what you think and would do!
Thanks Lauren!
Cant believe its come to this! Life is precious!
Regards, xxx
Subj: Re: Hi Lauren
Date: 10/31/2007 4:24:20 AM Pacific Daylight Time
From:
To: LGLBGL2003
Right-click picture(s) to display picture options

In a message dated 10/30/2007 9:20:46 P.M. Eastern Standard Time, LGLBGL2003 writes:
Hi xxxx! It's so nice to meet you, albeit under sad circumstances...first I can tell you, don't panic. The follow-up contrast MRI and spinal tap you are going to be having soon are precursory for most neurologists to provide a final diagnosis of MS. Believe it or not, you could not have been diagnosed with MS at a better time because the diagnostic testing and medications for MS have improved so much over the last five years, you are lucky!

You are such a trooper...and smart too in wanting to use only Tysabri. If you can convince your neurologist that you are "needle phobic", and won't comply with the regime of the ABCRs, he just might qualify you for Tysabri in that the FDA states "Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate (needle phobic), alternative multiple sclerosis therapies."

You will probably want to start some sort of treatment right away to calm down the inflammation causing your optic neuritis, and the best way to do that is treat that with steroids (either prednisone or IVSM- Solu-Medrol). Double check with your neurologist.

If you need to find a Touch Certified neurologist in your area, I would suggest that you contact Melanie Stephenson at MSActiveSource (she's the Supervisor of Patient Support Services that I've been dealing with). Her direct line is 1-800-456-2255 extension xxxxx. If you would like, you can mention that I referred you to her. She is out of xxx too... how great is that?

Remember xxx, having MS is not the end of the world...you have become your own patient advocate and can help shape the worlds of other MS patients out there that have been lost for years, searching for information that can help them. Think of your life with MS as an opportunity to help others, while helping yourself - you've got a leg up on them!

Please, please, please keep me posted on your progress, and if you need me, I'll be here-don't ever hesitate to contact me.

Hang in there dude, it's going to be all right :)


Lauren
A very
proud member of:
www.MSPatientsForChoice.org

Lauren,
Thank You so much for that informative letter. I wonder why he hasn't started steroids yet. Is he waiting for results of spinal tap? I would like them now do to my fear of losing more vision. I dont know why he hasnt given me any.
I will call Melanie today. I hope there is one local who is progressive and knows best. ABCR's are the drugs Avonex, Copoxone and Rebif to name most? All those drugs seem bad from what I have read. More side effects than Ty ever will have.I just dont get it.
Thanks again and I will keep you informed. Have to run to MRI....YUCK!!
Your Friend, xxx
From: xxx
To: msladyinca
Move To
Date: 11/1/2007 9:05:40 PM
Subject: RE: how did your MRI go yesterday?

Lauren,
You are so sweet. Thank You for thinking of me. The MRI went ok just took awhile to get in but once in it was 10 minutes. The contrast was no problem. No results yet.
I had the spinal tap today at 9pm. It went ok too under flouroscopy. She needed to put more under my stomach to get the spinal colume apart enough for the needle to go through. I have been laying down all day in bed. I am getting on couch now and sitting at pc a little. Its getting a little sore now though. No headache!!!
The best news is that Andy called from Biogen Idec for Touch prescribing. Man is he awesome. Answered all my concerns that I had. He told me of local doctors in town who prescibe Ty and the same people have a Ty treament center there. I was so happy. Plus I found out my insurance would cover Ty and that it cost in the same range as the others. I am happy to find this out, good neuros who don't make you fail and go blind in one eye prior to Ty. I have much new confidence now.
So I guess the Spinal tap takes 7 to 10 days..Plus they drew more blood work for PgE levels I believe.
Thanks for your help with hooking me up with the Biogen people. They mentioned your name on the phone along with Melanie's. Its so nice to have people who are willing to help in time of need. You are such an angel for me.
Thanks so much!!! Will stay in touch!!! xxx
---------------------------------------
To: xxx

Date: 11/1/2007 10:03:55 PM
Subject: RE: how did your MRI go yesterday?
Oh xxx, I am so glad that you had no problems today.... oh man, no headache from your spinal tap? I am sooo jealous! When I had mine (two actually) in 1975, I had a migraine for week and a half... looking back, I can laugh now, but sure as heck wasn't funny then!

You said "They mentioned your name on the phone along with Melanie's. " Did you call Melanie's extension first? How did the people of Biogen know about me? Hmmm, That's too weird, maybe I have a reputation over there now-? (don't mess with that lady Lauren) LOL.

I'm just so happy that you had a good experience with MSActiveSource, plus your insurance will pick up Tysabri if you go on it, no headache from the spinal tap, and no allergic reaction to the contrast dye (gadolinium). Heck, I'd say you had a pretty good day all the way around!

Lauren :)

You all know how I feel about being your own patient advocate, and the above is a classic example of how we each need to be proactive when it comes to our health care.

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

Wednesday, October 31, 2007



My Tysabri Diary...with Halloween fast approaching, I wanted to send a very quick note to everyone wishing you all a very safe and happy Halloween night.

The photo above reminds me so much of my Champagne golden retriever who has now passed on... he was such a goofball, and born two days before Halloween. I think that was his favorite holiday, with Christmas running a close second. He used to get such a kick out of the young children that came trick-or-treating, and if any of them were too scared to come to our door (my ex used to put out very scary decorations), he would pick up the jack-o'-lanterns full of candy and take them out to the sidewalk where the children were crying. He would sit down and just hold the jack-o'-lantern in his mouth by its handle, tail wagging the whole time.

The parents of the children that were crying would just smile and laugh while consoling the younger ones, petting him on his head and then coaxing the younger ones (who had finally stopped crying by that time and were also petting him) into reaching into the jack-o'-lantern for a piece of candy. It was just sooooo sweet to see. I usually used up at least two rolls of film each Halloween - LOL.

Have a good one!

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

Monday, October 08, 2007

My Tysabri Diary... Jacqueline's Story of MS...she is only 22 (the same age I was when I was diagnosed with MS), but she had a very aggressive form of MS and was becoming severely disabled.

However, she now has her life back thanks to Tysabri. Here is her story (translated from German), and the “you tube video” link below is also in German, but recovery in any form from a severe disability is easy to understand in any language...(she is the second patient on the video and you will recognize her because she is so very pretty). Enjoy! :)

zeitschrift_mslife_news_12_neu

Jacqueline talks ….

Jacqueline is only 22 years old, an attractive young woman from Bremen.

She walks through her apartment as if it was the most normal thing for her to do.

Nobody would have guessed that this wasn‘t possible just a few months ago, when she was feeling very badly and could hardly move.

Jacqueline Carnevale came down with a very active form of Multiple Sclerosis. Even the doctors had given up hope. “ Miss Carnevale, we cannot help you anymore” were the doctors’ estimates approximately one year ago, when the disease was at its height and no therapy was of any help.

Meanwhile Jacqueline has picked up her education again to become a specialist for job-seeking people at an employment office. Jacqueline is extremely happy that all this is possible again.

MS hits early and hard:

She was only 18 years old, had her first apartment and had just started her education at the employment agency, when she had her first MS symptoms. “I felt that my belly was numb, one half of my belly and my back”, Jacqueline recalls. Additionally there were circulation problems, and finally there was a circulation collapse when she was at home.

The next day, while in the hospital, she received the following diagnosis: “This is nothing serious, something like this can happen, it‘s only an inflammation of the spinal cord, it will stop again”. After 2 weeks in the hospital and a cortisone therapy, it seemed that this was really the case and Jacqueline went home again. But 6 months later, the same symptoms were happening all over again.

“From the computer- tomographic pictures the doctors could see that there had been 6 relapses during the last 6 months,” says Mrs. Carnevale. “Now it was obvious that this is MS”.

From here on, everything only goes down hill. One relapse is followed by the next..., in the beginning, she complained about loss of sensitivity, no balance, and then the damages increase more and more, until there is no more movement in her arms and legs.

It was taking longer and longer for her each time to recuperate from each new symptom and for her body to regenerate the normal sensations again, until in the end, there isn’t any more regeneration at all. The lowest point in her health was reached in summer 2006.

After another severe relapse, Jacqueline was brought to her mother because she couldn‘t help herself around any longer.

While others were enjoying their summer vacation, Jacqueline Carnevale had to endure her darkest hours of her young life: she is bedridden, and her mother has to bring small cut up food to her, and her mother had to pick her up for the bath tub. “ That to me was the worst part”, says Jacqueline, “ the dependency on my mother to be washed, being 21 years old!”

Yet, the things her mother did for Jacqueline, meanwhile are deeply engraved in Jacqueline. Coming with the disease, Jacqueline's relationship with her family has improved a whole lot. "I now know that my mother will always be there for me, no matter what", says Jacqueline in a very convinced tone of voice.

And then there was the turn-around:

Jacqueline’s family, and a new medication (Tysabri) were the reason for her new laughter and happiness. Until summer 2006, Jacqueline had tried all MS therapies on the market, including plasma pheresis. - Nothing helped.

Jacqueline‘s neurologist in the hospital was about to introduce chemotherapy to her when she became extremely reluctant and asked for really low doses. Her doctor must have picked up on Jacqueline‘s mood and suggested a brand new therapy, Natalizumab (Tysabri).

Jacqueline wanted it right away, but her doctor insisted that she wait at least take 24 hours to think about this new medication.

In a rehabilitation center, where she had spent a few weeks with other young MS patients, and where she had to learn how to cope with a wheelchair, Jacqueline had heard of Tysabri. The neurologist there had told Jacqueline that her disease was too advanced, and he didn‘t think that Natalizumab could be of any help in her case.

Even though some of her friends and relatives were not in favor of her taking Natalizumab, nobody could really change Jacqueline‘s mind. Not now... especially since her own neurologist suggested it to her.

She was overly excited to accept this new medication, right away. “I wanted to take that chance to get on Tysabri, no matter what. And this was the best decision I have made in my life time”. Jacqueline still says today, “from that time on, everything changed, the relapses stopped, and my body was able to help itself – it was as if I was born again!

Slowly, parts of her long lost sensations came back bit by bit, and her mobility was there again. She is no longer dependent on others, and her wheelchair no longer needs to assist her. Jacqueline once again is a young woman with dreams and hopes for her future.

She started her own MS group for MS patients age 15 to 30, she is giving interviews and has even taken part in a little MS movie. Jacqueline thinks it is very important to inform not only the MS community, but also reach out to as many people necessary in order to enhance the awareness for Multiple Sclerosis.

Her advice though for MS patients, in relation to her own therapy: “ The best thing is to go out and get as many professional opinions you can get – and then decide for yourself … “

http://www.youtube.com/user/schubfrei

Was this an inspirational story or what?

(((hugs to all)))

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

Sunday, October 07, 2007


My Tysabri Diary...happy Sunday to all of you!

Here is an e-mail that I just sent off to the National Multiple Sclerosis Society...And the National Multiple Sclerosis Society is supposed to be keeping MS patients informed and up-to-date? Good grief, they irritate the hell out of me...and is Biogen or Elan doing anything about this either? Sheesh. Won't you send a quick e-mail out to them too, please?


Oh, and today I stood up for approximately 15 seconds before my knees buckled underneath me... Woooooooohooooooooo! (Albeit with my caregiver holding on to me)... I know it really doesn't sound like much to most of you, but for me, being stuck in this wheelchair since June 5, 2005... this is HUGE. Lordy, I love Tysabri (hate the physical therapy though) heehee. Have a good one guys -

Subj: NMSS Website Update Needed-Priority: High
Date: 10/7/2007 1:04:08 PM Pacific Daylight Time
From: LGLBGL2003
To: Cathy.Castor@nmss.org
CC: public.affairs@biogenidec.com
BCC: chris.burns@elan.com, Kmartin@elan.com


Dear Ms. Castor:

I hope this e-mail finds you well. I have reviewed the NMSS website regarding Natalizumab/Tysabri, and I find the data from the NMSS site woefully outdated. This data is being released through Google Alerts as of yesterday, October 6th, 2007.

Specifically, your website information located at:
http://tinyurl.com/3dghrl indicates: "At the present time, safety and efficacy of treatment with Tysabri beyond two years are not known...Last updated August 7, 2006", when in fact Three Year Safety and Efficacy data was released quite a while ago. See: "The findings from the safety update combined with the data showing the sustained effect of TYSABRI in patients treated for up to three years, contribute to our evolving understanding of the utilization of this therapy as an important treatment option for people living with the debilitating effects of MS," said Paul O'Connor, MD, St. Michael's Hospital, Toronto, Ontario, Canada, lead investigator of the TYSABRI extension study" 3 May 2007 Data Presented at the American Academy of Neurology's Annual Meeting Provide Update on Utilization and Safety of TYSABRI® in Patients with Multiple Sclerosis Additional Data From Extension Study Presented Show TYSABRI Benefit is Sustained Over Three Years http://www.elan.com/News/full.asp?ID=995005

Obviously, the National Multiple Sclerosis Society is performing a terrible disservice to MS patients by providing them with only outdated information regarding Tysabri.

It would be appreciated if the NMSS would update their website immediately as to this most current Natalizumab/Tysabri information above, so that MS patients can be readily kept apprised of up-to-date information with regard to their DMD treatment options.

Respectively submitted,

Lauren Roberts


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

Friday, October 05, 2007



My Tysabri Diary...13th Tysabri Infusion Report

I just got back about 20 minutes ago from my 13th infusion at the new site which is close to my home...I timed it one way, it was 8 minutes 43 seconds!
Woooohoooooo! That's a far cry from 90 minutes one way to my old infusion site.

This is a smaller Kaiser infusion center and they are much more accommodating to their patients. They are currently infusing Tysabri in three patients, with another one being added next week.


Initially, the first infusion nurse to try and get a needle in my wrist, couldn't.... so then she tried (unbeknownst to me, because my hands are numb) to try to get a needle into the top part of my hand... well, I knew when she hit bone!!! My poor right-hand looks like someone hit it with a baseball bat and is soooo bruised, owie.

After I let out a bloodcurdling scream, a new infusion nurse (which I remember from when I used to receive my Solu-Medrol treatments out there), took over and said "Lauren, don't worry, I'll find a vein, and I'll be your infusion nurse each time that you come in each month." Yaaay!

One stick, she was in, hardly felt anything at all, and after my required 30 minute Saline drip, I started receiving my liquid gold - Tysabri...aaaaaaaaaahhhhhhhhhhhh. Heehee.


I'm pretty tired right now (which usually happens to me right after my infusion), so as soon as Ray (my caregiver) comes back with pizza and mudslides (Yaaay again!), I'll probably turn in early...boring Friday night, eh?

I can hardly wait until tomorrow when I wake up and find my renewed strength... hope, it's such a wonderful feeling - oh yeeeaaah!


(((hugs)))

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

Saturday, September 29, 2007


My Tysabri Diary...wonderful news!

TYSABRI® RECEIVES APPROVAL IN NEW ZEALAND
TYSABRI® RECEIVES APPROVAL IN NEW ZEALAND FOR THE
TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS

Auckland, New Zealand – 27th September 2007 – Biogen Idec NZ Limited and Elan Corporation, plc (NYSE: ELN) today announced that TYSABRI® (natalizumab 300mg) had been registered as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse.

The registration was based on a submission that included TYSABRI two-year Phase III clinical trial data and findings from a comprehensive safety evaluation. An estimated 4000 people in New Zealand are affected by MS.

“Today marks an important step forward for the New Zealand MS patient community,” said Eric Fidelin, Managing Director of Biogen Idec New Zealand. “TYSABRI represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice.”
###
ABOUT TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States 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)>

Oh my gosh, I'm so happy for them....YeeeeeeeHaaaaaaaw!

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

Thursday, September 27, 2007

My Tysabri Diary...Yesterday September 26, 2007 I listened to the national teleconference presented by MSActiveSource Re: Tysabri and the speaker was Dr. Heidi Crayton...here are a few of the notes that I took and if they happen to replay the telecast, I'll post the link for it. When I listened to the conference yesterday, I called 1-866-955-9999 to register for it and then I was given number 1-800-399-5094 and the code 13218633 to listen to it, so I am not sure if it is still available, but here are my notes: (remember these are her opinions, not mine):

She indicated that there are over 16,000 patients worldwide currently on Tysabri therapy, with more doctors and more patients feeling comfortable using Tysabri. More and more patients are asking to be placed on Tysabri therapy, especially because the infusion starts to work within weeks, as opposed to the ABCRs which can take up to months for them to start working. She said that most of these Tysabri patients start to feel better after their Tysabri infusions, i.e. she attributed this to the patients feeling they had a better Quality of Life.

She said she has had many success stories using Tysabri, and usually patients feel its effectiveness after the second infusion or approximately 6 weeks from the first infusion. She does not normally pretreat, but if she does, she use an antihistamine such as Claritin because Claritin does not make the patient drowsy.

She indicated that the patient's MRI results are good also, specifically in relapsing remitting and secondary progressive MS. Tysabri shows 67% efficacy (two thirds) over the ABCRs which only show a one third efficacy. Avonex at Rebif are the only injectables which show a reduction in relapses.

Regarding the patient's MRIs, Tysabri shows 76% reduction in black holes, which the ABCRs cannot address.

When discussing PML, she indicated that it was caused by Avonex plus Tysabri, and not Tysabri alone (she was adamant about this). She disagreed with the risk of 0.1% and stated it was actually much lower than that (she believed) when used as a monotherapy.

She went on to discuss the Touch program, indicating that patients are watched very closely and their health is monitored once a month because of the Touch program. All patients receiving Tysabri are watched better than patients that inject any of the ABCRs, so in actuality, the patient receives excellent care when it comes to their therapy.

She indicated that Tysabri was for relapsing forms of MS, which include relapsing remitting, progressive relapsing, and secondary progressive with relapses, which can be used as either a first line or second line therapy.

She discussed the fact that all of the treatments for MS have risks, including liver damage and depression from the interferons.

When discussing the options of Novantrone versus Tysabri, she indicated that she was very happy to have the option of using Tysabri over Novantrone, especially in younger patients because Novantrone causes infertility. She also indicated that Novantrone has risks of its own including cardio risks, permanent heart damage (to the heart muscle), leukemia, etc.

She also discussed Tysabri's mechanism of action against MS, but my numb hands were too tired to try to write anymore (besides, I could hardly read what I wrote to begin with- LOL!).

All in all, this was an excellent, informative program and I hope that many MS patients were able to listen to it.

Wooooohoooooo, it's about time!

Take care everyone...,

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

Monday, September 17, 2007

My Tysabri Diary...

I just returned from my one year follow up appointment with my neurologist, and I am pleased to report that she was "delighted" with my progress (those were her words).

What she was most happy about is that she did not feel I was progressing in my disease, and that what I thought was a mild relapse in early May of this year...was really not a relapse at all but a pseudo-exacerbation when I was so upset over Mina's death, soooooooo, no relapses in a year and no disease progression = WOOOHOOO! She also did not feel that a follow-up MRI was necessary, as she only saw good things when it came to my examination (strength, coordination, balance, etc.), and these were her findings, not my subjective opinions as relayed to her. She also said that if I wanted another MRI, she would order one, but she was trying to save me from the ordeal.

I guess because I live with this disease, and I struggle with its daily challenges, I initially did not think that she would be delighted. I am of course happy that I am able to continue with my Tysabri infusions, I just thought that she was going to be more disappointed that I hadn't made more significant improvements in my symptoms (actually I had been more disappointed than anyone, because I had only felt these minor improvements for about three weeks after my infusions - however never giving up hope and trying to maintain a positive attitude)...but not after this appointment, I'm flying!

She does want me to continue with my physical therapy exercises, and I wowed her with what I had accomplished to date (especially my improved strength). She does however want me to work on my "hip flexors" (I think that's what she called them) which enables the foot/leg to be lifted upright (aka vertically from a sitting position), and which enables one to take a step/walk. She wants my caregiver and I to be trained by the physical therapists in the exercises that will best help me in this area? We need to follow up with Kaiser in this regard.

She also said that of the Tysabri patients that she is aware of within her practice (that being in So. Calif. Kaiser), she believes that I am doing better than most of those patients. When I asked her how many patients she was talking about, she said roughly 10 to 15, but she has not asked the different neurologists throughout Kaiser, as she mainly stays focused on me as her most challenging patient - LOL.

Now I am off to do more grueling physical therapy exercises... no pain, no gain - right?

Have a great day everyone.

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

Friday, September 14, 2007

Tysabri:

To the MS patients that are confused over the recent article that was released by HealthDay (specifically from "reporter" Amanda Gardner), here was my e-mail reply to HealthDay and I suggest that anyone else concerned about these anti-Tysabri biased reports from her also e-mail HealthDay at the address listed below.

These reports are outrageously slanted, ugh!:


Subj: Article written by Amanda Gardner 9/13: Priority High
Date: 9/14/2007 2:27:15 PM Pacific Daylight Time
From: LGLBGL2003
To: editors@healthday.com


Gentlepersons:

I am writing you today in reference to the article written by Healthday News Reporter Amanda Gardner dated September 13th, 2007 http://news.yahoo.com/s/hsn/20070913/hl_hsn/stoppingtysabrimayworsenms
as well as the article http://www.sciencedaily.com/releases/2007/09/070912163524.htm which had several inaccuracies.

Specifically, with regard to the September 13 article, she incorrectly states: "
But the drug has a checkered past. It first received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy"

The medication that she's referencing, Tysabri/Natalizumab, was not pulled from the market (which implies the FDA required it to be pulled). Tysabri was voluntarily removed from the market by the manufacturer Biogen IDEC, until a comprehensive and thorough safety review had been conducted, which took more than a year. Furthermore, "several" patients in the clinical trials did not develop progressive multi-focal leukoencephalopathy. Three patients developed PML, wherein two of the patients had compromised immune systems with a drug interaction/combination Avonex therapy, and the third patient (a Crohn's patient) that also had a drug interaction due to having a six year history of Azathioprine use, which rendered him severely immune compromised.

With regard to Ms. Gardner's opening 'sensationalized' statement: "
People suffering from multiple sclerosis who stopped taking the controversial drug Tysabri experienced a resurgence of brain lesions associated with their disease, researchers report.", MS patients are now confused and scared of Tysabri, and she has done a terrible disservice to these MS patients that need Tysabri. Since September 13th, I have received several e-mails from distressed MS patients after reading her articles.

Then towards the end of her "rebound" article, she briefly mentions "
"Virtually all of the high-rebound figure came from the group that had a mean duration of therapy of only two months. I think that's relatively reassuring for the drug," Richert said."

While I understand that she was quoting the original report from Online Neurology, her article was extremely misleading in that:

It takes approximately 2 months for Tysabri to fully leave the body;

Far too much weight is being given to a the "observational" study which involved a mere 21 patients at this ONE facility;

Was this just a problem at this one site or a universal finding?

Were any of female participants post-pregnancy?

Late term pregnancy is protective from relapses, and then post-pregnancy has a higher than usual rate of relapse. That is why many MS patients choose to go
back on therapy quickly after pregnanacy;

Were any of the participants in the original monotherapy trials [Affirm]?

Were any of the participants in the combination trials [Sentinel]?

The larger question is whether the patients were placed on another agent or just withdrawn from Tysabri? If they were not placed on another medicine within 1 month of their last Tysabri dose, then that could be the problem;

If this site washed out for months and other sites switched quickly to Tysabri, there may not be a big issue;

Also of note, rebound was noted in the rodent EAE model when oral antiVLA-4 agents (act the same as Tysabri) were used. The average active study patient was on Tysabri 30 months or so and the placebo switched patient 6 months or so. Their finding of a difference between Tysabri/Tysabri and placebo/Tysabri patients could have a simple explanation;

Mechanistically, one can think that there are many myelin reactive T and B cells floating around the periphery (blood and lymphoid tissues) unable to get into the brain to expand and cause a plaque while a patient is on Tysabri. As Tysabri goes away over 2 months, the surviving cells can come into the brain. After a long period of Tysabri, there will be fewer living activated cells in the periphery than there would be after a short period, so less rebound could occur;

A larger controlled study previously addressed this issue of "rebound effect", which completely contradicts the smaller, non-controlled study. Obviously this larger multi-site study (incidentally in a population similar to the placebo/Tysabri group) has much more weight than a single observational site study with 1/10th the number of patients that were involved in the extension study where compiled data was from every site (hundreds of patients).
The full article can be found at: http://www.emea.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-en6.pdf
.

As a MS patient for over 31 years, and current Tysabri patient, it is my belief that when discussing these kind of "sensationalistic" findings, one has to be very careful as these kinds of reports written by Ms. Gardner are "sketchy" at best, and can/are causing needless worry and panic in the MS patient community, and indeed in the Crohn's patient community as well.

It is difficult enough as it is that we have to deal with an autoimmune disease (which is chronic and progressive in nature; which has very few effective treatment options-posing a very real and tremendous unmet medical for a disease which we must fight daily; including the social stigmas attached thereto), but we now have to deal with articles such as Ms. Gardner's?

For Ms. Gardner to just "gloss over" the realities of suffering patients with partial and misleading facts as I have indicated above, rather than completely and fully emphasizing them at the forefront of her articles, ultimately renders her articles rather misleading and egregious (which includes HealthDay).

It would be appreciated if a correction statement were added to these articles and reprinted today, which will obviously calm the fears of many patients who are reading these articles written by Ms. Gardner.

Very truly yours,

Lauren Roberts
(MS patient and Tysabri user)


***
Maybe if enough people e-mailed HealthDay, they will issue a corrected statement.

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

Thursday, September 13, 2007

Tysabri vs. Avonex, Betaseron, and Rebif (Interferon Beta)...Is your Interferon Beta therapy as safe as you really think it is???

Just take a look at what I found, and hold on to your chair because you might fall out of it!

http://www.rxlist.com/script/main/art.asp?articlekey=83785



From 1998-2005, the eight-year period covered, INTERFERON BETA was
ranked #8 on the list of "suspect drugs" causing death with a WHOPPING (to me, anyway) 1178 reported.

It also
ranked #4 in the list of suspect drugs causing death, disability or having other serious outcomes combined for a total of 9498 SAEs (Serious Adverse Events) reported.

Most Frequent Suspect Drugs in Death and Serious Nonfatal Outcomes, 1998-2005
Drug Name-Rank/Deaths-Drug Class Death: Most Frequent Suspect Drugs in Death
and Serious Nonfatal Outcomes, 1998-2005
Drug Name Rank/Deaths Drug Class
Death outcome
Oxycodone 1/5548 Opioid analgesic
Fentanyl 2/3545 Opioid analgesic
Clozapine 3/3277 Antipsychotic
Morphine 4/1616 Opioid analgesic
Acetaminophen 5/1393 Analgesic
Methadone 6/1258 Opioid analgesic
Infliximab 7/1228 DMARD
Interferon beta 8/1178 Immunomodulator
Risperidone 9/1093 Antipsychotic
Etanercept 10/1034 DMARD
Paclitaxel 11/1033 Antineoplastic
Acetaminophen-hydrocodone 12/1032 Combination analgesic
Olanzapine 13/1005 Antipsychotic
Rofecoxib 14/932 NSAID
Paroxetine 15/850 Antidepressant

Disability or other serious outcome:
Estrogens 1/11 514 Hormone
Insulin 2/9597 Hormone
Infliximab 3/8754 DMARD
Interferon beta 4/8320 Immunomodulator
Paroxetine 5/8095 Antidepressant
Rofecoxib 6/7766 NSAID
Warfarin 7/6250 Anticoagulant
Atorvastatin 8/6022 HMG-CoA reductase
inhibitor
Etanercept 9/5586 DMARD
Celecoxib 10/4822 NSAID
Phentermine 11/4607 Antiobesity
Clozapine 12/4388 Antipsychotic
Interferon alfa 13/4162 Immunomodulator
Simvastatin 14/3885 HMG-CoA reductase
inhibitor
Venlafaxine 15/3688 Antidepressant

(I will just list the SAEs #'s for Interferon Beta) Drugs With 500 or More Reported Deaths and Serious Adverse Drug Events in Any Year

Interferon beta . . . Combined Total 9498 ...'98-349, '99-392, '00-769, '01-777, '02-1032, '03-1240, '04-2210, '05-2729


As I sit here typing this, fully aware of the serious nature of PML (btw, there was no Natalizumab/TYSABRI mentioned in the article despite covering through 2005), I'm thinking, let's see, it's OK to market a class of drugs to treat MS (i.e.,
INTERFERON BETA) that has caused over 1000 deaths and over 8000 SAEs over an 8-year period, yet, we have a new drug for MS (i.e., TYSABRI) that's twice as effective as the aforementioned drug class, and we encounter only 2 cases of PML (1 fatality in a patient who's diagnosis of MS was suspect at the time of autopsy) that can't even be attributed to Tysabri in and of itself, and this constituted sufficient grounds for having that drug withdrawn from the market for 18 months, as well as restrictions being placed on its use when re-released??? And MS patients are afraid to take Tysabri? And neurologists are afraid to prescribe Tysabri?.

What's wrong with this picture?

Here is the
Moore et al., Archives of Internal Medicine, abstract below:


Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005

Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD

Arch Intern Med. 2007;167:1752-1759.

ABSTRACT


Background The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers.

Methods Using extracts published for research use, we analyzed all serious adverse drug events and medication errors in the United States reported to the Food and Drug Administration from 1998 through 2005.

Results From 1998 through 2005, reported serious adverse drug events increased 2.6-fold from 34 966 to 89 842, and fatal adverse drug events increased 2.7-fold from 5519 to 15 107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. In a subset of drugs with 500 or more cases reported in any year, drugs related to safety withdrawals accounted for 26% of reported events in that group in 1999, declining to less than 1% in 2005. For 13 new biotechnology products, reported serious events grew 15.8-fold, from 580 reported in 1998 to 9181 in 2005. The increase was influenced by relatively few drugs: 298 of the 1489 drugs identified (20%) accounted for 407 394 of the 467 809 events (87%).

Conclusions These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.

I do hope that MS patients will fully arm themselves with this information if they are on either Avonex, Betaseron, or Rebif and are afraid of Tysabri... the numbers speak for themselves.


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

Thursday, September 06, 2007



My Tysabri Diary...
I had my 12th Tysabri infusion yesterday, September 5th. I was pretty tired the day of my infusion, so when I got home I took a very long nap.

The temperatures yesterday reached 104° and we hit rush hour traffic going to and from the infusion center, so I was pretty wiped out when we got home.


This being the next day however, I can feel my strength returning again and oh my goodness, it's such a wonderful feeling (better than any steroid treatment I ever had!). Woooohoooo!

Has it really been a year already? Time really flies when one has hope! My balance issues, my slurred speech issues, and my optic neuritis issues are slowly but surely improving with each infusion that I receive.

I am going to enjoy the next three weeks to the best of my ability, and continue to fight my MS with the most effective therapy that we have to date.

Tysabri continues to instill hope in me, and hope for others as well, as we battle this disease on the front lines with Tysabri!

Oh and by the way, I have received a lot of inquiries and e-mails regarding the Tysabri Brochure that I have been posting wherever I can so that other MS patients can see it as well, double Woooooohoooooo!


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

Wednesday, August 29, 2007


Tysabri Brochure! It is entitled "The STRENGTH To Reach Your High HOPES"

I received in the mail today from Biogen a 21 page Tysabri Brochure that is very well written for prospective Tysabri patients.

The above photo is what the cover of the Tysabri Brochure looks like. In order for you to view this on the Internet, it has been converted to a PDF file:

http://tinyurl.com/ytc2v3

Of special note is page 11 which states: "Of patients who took Tysabri in the two-year study: 8 out of 10 had no disease progression, or 83% of Tysabri patients had no disease progression at the end of the two-year study compared with 71% of placebo patients".... Whoa!

It includes important safety information and information regarding the TOUCH Prescribing Program, and states that it is important to understand the benefits and risks of Tysabri. Talk to your doctor to learn if it may be right for you, and it goes on to state:


Tysabri positively affects the three components of MS:
  • Frequency of flareups
  • Disease progression
  • MRI brain lesions
Tysabri is different from other MS medicines:
  • It works differently
  • It is taken differently
  • It is available only through the TOUCH Prescribing Program, which focuses on patient safety
I am not sure why I received this Tysabri Brochure which is obviously for "prospective Tysabri patients" considering I've been an actual Tysabri patient for 11 months now - LOL!

If you or your doctor would like further information regarding this brochure it suggests that you contact MSActiveSource at 1-800-456-2255.

I think that this is the first pro-active information I have ever seen written about Tysabri which is easy to understand for patients.

Woooohoooo, it's about time!

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

Monday, August 20, 2007



My Tysabri Diary... Hey now,
MORE GOOD NEWS re: Tysabri!

Here is more news regarding Tysabri demonstrating significant quality-of-life improvements for multiple sclerosis patients... it was just released today, August 20th.


I have provided a link for that data, which is pretty spectacular, but below the link I provided is just a small blurb from Dr. Rudick, Lead Investigator of the study, wooohooo!

20 August 2007
TYSABRI® Demonstrates Significant Health-Related Quality-of-Life Improvements for Multiple Sclerosis Patients in Study Published in Annals of Neurology http://www.elan.com/News/full.asp?ID=1041807

"These data showed that patients treated with TYSABRI were more likely to experience statistically important improvement in the quality-of-life measures used to assess meaningful disease improvement or progression. These findings have not been previously observed in clinical studies involving MS patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, the lead investigator of the study."

Impressive, huh?

(((hugs)))


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

Sunday, August 19, 2007



My Tysabri Diary...hi everyone, I have a lot to say today about Tysabri.


1) I am posting a FDA Memorandum that clarifies any erroneous misinterpretation by both doctors and patients regarding Tysabri's use (it
IS a first-line AND/OR second-line therapy for MS)...woohooo (laughing at myself);

2) I am posting an e-mail that I sent to Biogen's public affairs department due to the fact that Biogen has not even updated their Tysabri Central Information Center page in over a year, and yet they show at the bottom of that page the year 2007! Ugh! I am becoming more and more disgusted with Biogen as each and every day passes.

Please feel free to e-mail their public affairs department as well (you can send it anonymously if you prefer and their e-mail address shows below in my e-mail to them) if you are disgusted too with them. I am sure that a large percentage of why they are doing to this (purposefully keeping MS patients and neurologists in the dark regarding Tysabri) is so that they can keep promoting Avonex sales, either that or they're just plain lazy.

"
Clarification Memorandum by the FDA regarding Tysabri's use as a first-line AND/OR second-line therapy for MS patients"

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH


SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007

In the reviews, Tab 1 (FDA Clinical Review) and Tab 2 (Office of Surveillance and Epidemiology Review), it was stated that the MS population to receive Tysabri should be those “unable to tolerate or with an inadequate response to other available MS therapies” and it was stated that the indication was revised to “relegate it [Tysabri] to a second-line therapy for relapsing-remitting MS.”

The indication in the current label states “…Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies.”

FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommended for patients who have had an inadequate response to, or are unable totolerate, alternative multiple sclerosis therapies (e.g., as second-line therapy).

However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.

(FDA Memorandum above which is in PDF format: http://tinyurl.com/2989yp)


Subj: Updating your news information page regarding Tysabri-Priority High
Date: 8/17/2007 5:16:49 PM Pacific Daylight Time
From: LGLBGL2003
To: public.affairs@biogenidec.com
CC: chris.burns@elan.com, Kmartin@elan.com
Tim Hunt, Vice President
Naomi Aoki, Director
Amy Reilly, Associate Director

Gentlepersons:

As a MS patient for 31 plus years, former Avonex user, and current Tysabri patient that has had 11 infusions so far, upon reviewing your full news information page (Natalizumab) Information Center regarding Tysabri (see: http://www.biogenidec.com/site/news-and-media.html?pr_id=../site/tysabriinfo_letter5.htm
), your information posted there is woefully outdated (July 2006), considering as of mid-July 2007, Tysabri has been back on the market for over a year, with approximately 14,000 plus patients currently receiving Tysabri therapy with not one single case of PML or other opportunistic infections reported in these MS patients being treated with Tysabri since that time.

Furthermore, it appears at the bottom of that page that your website is currently updated (
2007 Biogen Idec).

While I do understand that all communications with patients, including changes to patient-oriented websites (such as MSActiveSource.com and Tysabri.com) need to be approved in advance by the FDA, Biogen's failure to even update their Tysabri Information Center page in over a year is particularly egregious.

By failing to keep potential prescribing neurologists and potential MS patients/users updated with the most current information regarding Tysabri for MS, Biogen Idec is providing a terrible disservice to the MS community, as well as allowing for a MS patient currently on one of the lesser efficacious ABCRs to possibly/probably suffer a relapse with resulting disability, which could be permanent.

In addition, while I also understand that Biogen has been conducting Tysabri seminars throughout portions of the US, many disabled MS patients who cannot travel, as well as busy neurologists, can and should be updated through your website (specifically, Biogen's homepage Letter to the MS Community, and your Natalizumab/Tysabri Information Center homepage Letter to the MS Community).

Your immediate attention to the above, and reply to this e-mail, is appreciated.

Sincerely, Lauren R.

****
Maybe someone over at Biogen will wake up and smell the complaints that will be coming in once others start to bombard them with their own e-mails that discussed the above.

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

Thursday, August 09, 2007

Tysabri, My Tysabri Diary...My 11th Tysabri infusion was yesterday, and boy oh boy - do I feel like Barry Bonds today! (Although I can admit that this feeling is drug enhanced - heehee).

I can still wiggle my toes a little bit this morning and move my feet slightly, my balance is improving, as well as my strength, speech, cognition, and coordination. Even though these improvements for me don't last the full 28 days until my next infusion, when I do feel them again, the feeling is just awesome,
woooohooooo!

Considering August is the month for the heat of the Summer to kick in, and a majority of MS patients don't do well in the heat (the heat can cause relapses and exacerbations of MS symptoms), I am doing really well at this time of year and my active MS has been abated/controlled outstandingly with the help of Tysabri.

Even though I am not receiving outstanding results like some MS patients are, I am still thrilled with the use of Tysabri because it is preventing further relapses and slowing my disease process down.

I can and will never lose hope for making more improvements (even in the face of reality) with Tysabri because for me, Tysabri = Hope!

Yesterday, during my infusion, a lady in the infusion chair next to mine, struck up a conversation with me regarding autoimmune diseases. She was about my age and receiving Remicade for her rheumatoid arthritis. She is also on methotrexate and prednisone, and has her liver checked regularly. She asked me what medication I was on and for what, so I told her Tysabri for Multiple Sclerosis, and briefly discussed Tysabri, its side effects, its current uses in MS and soon Crohn's disease,
and its prospective uses, as well as the bad rap (PML) it received.

She asked me if she could see the Patient Medication Guide that they give me at each Tysabri infusion, and I said of course (I had at least 10 of them - LOL). She is actually a very lucky patient with RA because it is only in her feet and hands - it is not in her back, neck, or knees (as of yet), but she wants to discuss fully the side effects of Remicade, prednisone, and methotrexate with her doctor.

She also wrote down the Elan website, the MSPatientsForChoice website, and we exchanged phone numbers. Odd, could she actually be starting the journey of becoming her own patient advocate? Ha!


We actually hit it off pretty well because she lives not too far from where I used to live...and we talked of old times there.


Her infusion time is approximately 4 hours every five weeks, and my infusion time (one hour, and then one hour observation time) just flew by this time, and before I knew it, my infusion nurse was unhooking me and telling me that I was free to go!

All in all, it was a wonderful infusion experience, and now I am off to do my PT exercises.

Woooooohoooooo for stabilization of my MS and wooooohooooo for Tysabri!


Have a great week everyone,

(((hugs)))
Love, Lauren :)

A very proud member of www.MSpatientsforchoice.org

Sunday, August 05, 2007


My Tysabri Diary... Hi everybody... we have a
new feature on MSpatientsforchoice which is a forum based link for the community (patient, family, friends, caregiver, and so on) to gather together, introduce themselves, ask questions about MS, the different MS drugs, or just talk about their MS, etc. The link ("Community") is listed on the homepage of our website at the top. The newest post there was from a lovely lady who was researching MS information for her friend that was just diagnosed with MS.

It's brand-new, and
wow, we are already getting new people every day signing up and posting there! If you are interested in reading the information posted there, want to ask questions, or just share your MS experiences, go to: http://www.mspatientsforchoice.org/community/viewforum.php?f=1

I go for my 11th Tysabri infusion on Wednesday the 8th, and boy am I feeling I need it! I had to remember to ask my caregiver to pick up some more Claritin the next time he was at the market (I take a Claritin about 30 minutes before each of my infusions to eliminate and/or reduce any potential side effects), which so far have been NONE! Woooohoooo!

Now if I can remember that I needed more Claritin, Tysabri must be having a positive effect on my short-term memory loss!!! (Heehee)


More postings here after Wednesday....until then,

(((hugs)))

Love, Lauren :)

A very
proud member of www.MSpatientsforchoice.org

Wednesday, August 01, 2007



My Tysabri Diary...
Wooooohoooooo! Here is another WIN for patients! Oh I am just so happy for the suffering CD patients :)

Joint FDA Advisory Committee Recommends Approval of TYSABRI(R) for the Treatment of Moderate to Severe Crohn´s Disease 01/08/2007

Elan Corporation, plc (NYSE: ELN) and Biogen Biogen Idec (NASDAQ: BIIB) announced today that the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 12 in favor to 3 opposed, with 2 abstaining, to recommend approval of TYSABRI(R) (natalizumab) as a treatment for moderate-to-severe Crohn´s disease in patients who have failed or cannot tolerate available therapies.

The recommendation is advisory to the FDA, and the agency is not bound by this recommendation. Elan and Biogen Idec will continue to work closely with the FDA in the weeks ahead with the goal of making TYSABRI available for the treatment of appropriate patients with Crohn´s disease. Discussions with the FDA will include adapting the existing TYSABRI risk management plan and addressing any other issues raised during the Committees´ deliberations on this new indication.

http://www.elan.com/News/full.asp?ID=1034453

I believe the FDA renders its final decision in October 2007.

(((hugs)))

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

Monday, July 23, 2007



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


Tysabri Celebrates One-Year Anniversary - http://tinyurl.com/2twszd

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.

About TYSABRI

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.

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

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).

The
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,

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

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.

Many
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.

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

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!

http://guidance.nice.org.uk/download.aspx?o=419024

Easier article to understand: TYSABRI(R) Recommended by NICE for Use in Highly Active Relapsing Remitting Multiple Sclerosis in the Final Appraisal Determination http://www.elan.com/News/full.asp?ID=1022211

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!

(((hugs)))

Love, Lauren :D

A very proud member of www.MSpatientsforchoice.org

Sunday, June 17, 2007



My Tysabri Diary...Happy Father's Day and Happy 4th of July!

"You never said I'm leaving, You never said goodbye
You were gone before I knew it, And only God knew why
A million times I needed you, A million times I cried
If Love alone could have saved you, You never would have died
In Life I loved you dearly, In death I love you still
In my heart you hold a place, That no one could ever fill
It broke my heart to lose you, But you didn't go alone
For part of me went with you, The day God took you home."

"When I was:
Four years old: My daddy can do anything.
Five years old: My daddy knows a whole lot.
Six years old: My dad is smarter than your dad.
Eight years old: My dad doesn't know exactly everything.
Ten years old: In the olden days, when my dad grew up, things were sure different.
Twelve years old: Oh, well, naturally, Dad doesn't know anything about that. He is too old to remember his childhood.
Fourteen years old: Don't pay any attention to my dad. He is so old-fashioned.
Twenty-one years old: Him? My Lord, he's hopelessly out of date.
Twenty-five years old: Dad knows about it, but then he should, because he has been around so long.
Thirty years old: Maybe we should ask Dad what he thinks. After all, he's had a lot of experience.
Thirty-five years old: I'm not doing a single thing until I talk to Dad.
Forty years old: I wonder how Dad would have handled it. He was so wise.
Fifty years old: I'd give anything if Dad were here now so I could talk this over with him. Too bad I didn't appreciate how smart he was. I could have learned a lot from him."
Authors Unknown

My father died when I was very young, so I can't say a lot of wonderful things about him because I can't remember if there were a lot of wonderful things about him. I do remember a few good things, but I also remember some very sad times when he was abusive towards me, my 3 sisters and my mom.
I learned later that it was the bottle that made him so mean, but nevertheless, I forgave him.... did his alcoholism rear its ugly head due to the pressures of raising a family? Providing for us? Was it something from his own childhood that made him drink? Would he have changed if he grew older? These are questions I cannot answer... at my age now, I'm sure I'll find out the answers soon enough.

The funny thing is, growing up without a loving father in my life, made me more patient and tolerant of others' insecurities, frailities, and shortcomings (to a point). It has also made me richly appreciative of kind, good friends and the little things in life. Perhaps this was meant to be after all.... perhaps not. I don't rightly know for sure. It is what it is.

What I do know is that we need to love the ones we still have with us because we never know when they're going to be taken from us..., and that includes people that we love which might inevitably become Alzheimers patients, lost forever to the disease.

Thank God we have hope in AAB-001, currently in Phase III clinical trials... Happy Father's Day to all the loving fathers out in cyberspace - including grandfathers. You are a special breed indeed.

(((hugs)))
Love, Lauren
A very proud member of http://www.mspatientsforchoice.org/

Thursday, June 14, 2007



My Tysabri Diary...

I returned home late yesterday from my 9th Tysabri infusion...and it went pretty well all things considered. I had a slight headache after the long drive to and from the infusion center and the rush hour traffic (nothing that a couple of Ibuprofen and good night sleep didn't cure), but overall I'm feeling pretty strong.
My infusion nurse advised me that they are currently infusing approximately 15 patients with Tysabri and enrolling more weekly...their youngest being 23 years old with Progressive Relapsing MS.
He then advise me that he heard Tysabri is going to be used in Crohn's patients pretty soon also, or so he read on the Internet. I asked him if he knew how Tysabri works in Crohn's disease and he said no not really. So I gave him a quick and brief lesson in Tysabri and CD, and I advised him that Elan holds the sBLA for Tysabri in CD, not Biogen...and that Elan's scientists discovered Tysabri, not Biogen's, and that Elan owns 50% of Tysabri.
He then asked me if I ever heard of the National Multiple Sclerosis Society? (Sheeeesh) I said yes I'd heard of them and then I asked him, " guess what the National Multiple Sclerosis Society and Biogen did for MS patients in helping us get the drug back?" He said "what?"
I said "they did absolutely nothing...it was Elan's investors that helped a lot of us MS patients get to Washington, DC to testify before the FDA Advisory Committee back in March 2006 in our effort to bring Tysabri back to patients that want and need it." (my testimony was presented and played via videotape due to an exacerbation I suffered in Feb. 2006, arranged for and paid for by a number of the Elan retail investors out of their own personal pockets.)
So after I finished my infusion and my one hour observation time, I obtained my next infusion date (28 days away...yaaay!).
I would like to thank each person that left me a comment offering their condolences and sympathies for the loss of my Mina. You will never know how much they meant to me at that very sad time in my life...my mind and my heart still keep thinking she'll come to me (like she always did) if I call her name (sigh)...oh well........,
(((hugs)))
Love, Lauren
A very proud member of http://www.mspatientsforchoice.org/