My Tysabri Diary..... - I received my 40th Tysabri dose yesterday...,,

Barely, it's as if Biogen is doing everything in its power to try and defeat the Touch program and make it almost impossible for the patient to receive the medication , grrrrrr! What a total fiasco I went through yesterday just to receive my much needed medication, Tysabri!

I'm sure that part of this problem I'm experiencing is due to Kaiser Permanente's policies, but I learned yesterday that the doctors prescription for Tysabri is totally separate from Biogen's Authorization..., in other words the doctors' orders/prescription for the medication is not good enough for the pharmacy to release the medication (even if they have it, which they did) until the pharmacy had a "Written Authorization" from Biogen to release the medication to the patient, say what?!?!? Two separate forms?!?!?

My regular infusion nurse had a line already in me, and faxed my doctor's orders to the pharmacy for them to start mixing my Tysabri, and while I was waiting, I was receiving saline (which should have been for only 20 minutes max), so my infusion nurse went into a meeting. During that time, apparently the infusion center (which has computers, and the notation was made there that the doctor's orders were good for six more months, with Authorization having been given by the manufacturer/Biogen). Well, after 45 friggen minutes, and still no medication having arrived at the infusion center yet, and my regular nurse still in a meeting, I started "raising Cain" so to speak, I mean after all, come on now - the infusion itself takes an hour, and my medication isn't even there yet???

There were two other "Touch certified" nurses at the infusion center, and they are telling me that this is a "research medication" and Biogen has to separately Authorized it??? Oooooh no, did I just hear them right??? I screamed out in frustration, "Tysabri is not a research medication, Tysabri is FDA approved, and your Touch Certified?!?? And furthermore, I saw the Authorization in my chart, and I was informed that the pharmacy has everything they need, and now you're telling me they don't??? Please go get my regular infusion nurse, now, as I'm not waiting five more minutes for a "professional" to try and explain something to me that knows absolutely nothing about Tysabri nor its protocol for heaven's sake!". ARRRRGHHHH!

My regular infusion nurse shows up, calls the pharmacy, and tells them that Biogen's "Authorization" is noted in their computer and to send up the medication ASAP, has a discussion with the two nurses there and shows them on the computer where the Authorization is duly noted, and that the patient (me) should not have to wait for her medication at all, that they need to read, not make up some BS explanation..., adding to this problem is the fact that the pharmacy (Kaiser Permanente's pharmacy) does not have computers linked to the infusion center's computers, and I was assured that this will never happen again..., Good Grief!

I'm still trying to figure out why Biogen has to authorize anything, I mean the doctor's order is in my chart, my neurologist is "Touch Certified, and the pharmacy is within the "specialty pharmacies" that are authorized to dispense Tysabri..., so why the "separate Authorization form"??? Don't they trust all of the rules and regulations they have already burdened patient with, and now just another rule and regulation???

So after all this hassle, I finally received my 40th dose of Tysabri, hallelujah!

Okay, I'm exhausted now and I need to go do my physical therapy, so take care everyone and enjoy your weekend...., Lauren

Hello everyone!

I had my 39th Tysabri infusion on Wednesday 9/30, but more important was the week before when I was invited by the Vice President - Corporate Relations of Élan Pharmaceuticals to speak at their Élan Employee Day on 9/25. My infusion went well with no problems, but let me get to my week prior to my infusion. The photos above are a few of my friends that got together for dinner up in San Francisco Thursday night-the night before I spoke at Élan : Ray, doodah, Me, Dexter, and Roy; Me and my friend Roy; my friend doodah snatching a little smoocherooooni; the band that performed at Élan's Employees Day; Mr. Kelly Martin (the CEO Of Élan Pharmaceuticals) & me; Mary Stutts (she's the Vice President of Corporate Relations) & me; Dr. Ted Yednock (he's the brilliant scientist that discovered Tysabri & he is my hero!) & me; my friend Pam that I met up there in San Francisco who also has MS and just completed her 39th infusion, me, and an Élan employee that was all over the dance floor!

I had such an awesome time at dinner Thursday night with doodah, dexterstinks, Roymulus, and my caregiver Ray. I am not sure if the food or the company at our table was more sinfully wonderful!!! All three of my friends mentioned above were so generous, compassionate, and caring, it was all I could do to not burst out in tears (happy tears) at getting to see doodah again but especially to meet Roymulus for the first time (none of you could ever know how absolutely wonderful this man is), and to meet dexterstinks for the first time as well..., everyone was so funny & gracious, I'm surprised I didn't choke on my food laughing or have my mudslide fly out of my nostrils. I just hope they all had a good time and if they only had a minute decimal of the good time I had, I know they enjoyed themselves.

The trip up to San Francisco was rather tiring on me, but all of the arrangements made by Élan getting up there and the accommodations they provided me with were great. It's the trip back home Friday night that was a disaster (no shuttle was available to pick Ray and I up once we landed), even though I had the confirmation itinerary which was previously sent to me by Élan. After a two hour wait upon landing, Ray finally made arrangements with the shuttle, and we both made it home after a total five hour delay, through no fault of Élan or the airline, it was the shuttle service ( grrrrrr ). And to top it all off, the shuttle driver was waiting for a tip... I was so p.o.'d off at them, the only tip I gave them was not to swim in shark infested waters !

A brief synopsis of what transpired on Friday at Élan is below, and Friday, 9/25, was not only the Élan Employee Day, it was their 40th birthday celebration for the company, and it was a huge, and I mean HUGE production they put on for not only their employees, but their guests as well! A live band (which was phenomenal), professional dancers in the band (which were also phenomenal), a film of Élan's history which was shown on two large screens, and food-food-food-and more food!

Some of the speakers were Kelly Martin, Shane Cooke, Carlos Paya, Mary Stutts, one of the representatives from J&J, so many people, I can't remember them all. Above are photos of Kelly Martin and I, Mary Stutts and I, my HERO TED YEDNOCK and I (he came over to talk to me after my speech and spent at least 45 minutes talking to me-and me talking to him-both of us trying to speak over a live band that was playing) so he told me that we could speak later...(he could not believe that was my very first speech, we talked briefly about PML, how that all came about, the continued research of what happened with the patients that developed PML, the immune system, my personal experience with MS, etc. etc.) and oh so many top executives & researchers & employees that came out to meet me personally and thank me for being there...,

but it was me thanking them for inviting me, and everything that they are doing for patients. They are some of the most gracious, dignified but humble, caring individuals that I've ever met in my entire life..., they completely blew me away! I could not remember everybody that came up to me, because I was so exhausted by the end of the day and I'm sure some of them thought I didn't want to speak with them, but that wasn't the case at all..., I just ran out of steam. So I hope that they understand if they are reading this message.

Mary Stutts told me that she will be providing me with a copy of the video they were making of the entire event, including all patient stories. I'm not sure when their professional videographer will make this available to them, but she definitely and most graciously told me that they would be happy to provide me with a copy of same. She also mentioned to me that they might possibly use portions of my patient speech on their "Patient Voices" website..., woo hoo!

So here is the brief synopsis of my speech (I was allotted five minutes): I introduced myself, thanked several people including Mary Stutts for inviting me to speak there, her assistant Julie (who was utterly amazing- Mary, she is worth her weight in gold), Mary's other assistant Myesha, Mr. Kelly Martin, Ted Yednock, and everyone who works at Élan; I told them how old I am, how long I'vehad MS, that I was the first person in both 2005 & 2006 through Kaiser Permanente in Southern California to receive Tysabri, the kinds of improvements I made/had in 2005 just two weeks after my very first infusion:

(my limp was gone, my right drop foot was gone, my slurred speech was gone, my optic neuritis was gone, I put away my walker & was only using my cane for balance, and on the day my second infusion was to take place, Tysabri was removed from the market and how devastated I was. I then mentioned to them that it was in June 2005 that I got hit hard with a severe relapse which left me in a wheelchair and they could see how disabling a severe relapse can be. I then mentioned so many thanks go out to David Kaplan for actually bringing together so many Élan investors to help mobilize and assist many of us patients getting to the FDA Tysabri hearings in March 2006, MSpatientsforchoice, and how everyone just came together to bring about this endeavor, including the videographer that was arranged to videotape my testimony and then the delivery process to get it out to be viewed by the FDA AC committee.

I then mentioned that I basically am all over the Internet, specifically the MS boards, providing accurate Tysabri information, answering e-mails from scared MS patients about PML, advising them not to be scared, not to believe all the lies that are posted by idiots on the different MS boards, to speak to their doctors, I tell them about my experiences with Tysabri, and not to be afraid if their immune systems are okay.

I closed by telling them that Tysabri has given me hope once again and I am no longer afraid of waking up wondering what MS has taken away during the night (you never know when you might lose your eyesight, you might lose the use of your hands, legs, right side or your left side, maybe one of these symptoms, maybe all of these symptoms at once). With Tysabri, my MS is now stable, I have not had a relapse in over three years, and no new lesions showing on my recent MRIs. I may never be able to walk again, but that is never going to stop me from having hope for a better quality of life which Tysabri has already given me.

After my speech, Kelly Martin came up to me and just started talking to me, asking me if I've ever given a lot of patient speeches before, and I told him no, that was my first one and I was so nervous I almost threw up (seriously-LOL). He looked shocked and said that was your very first speech? And I said yes. I wanted to talk to him more, but they whisked me away to help cut their 40th birthday cake, and when I was finally done, I was told that Mr. Martin had to catch a plane. Darn it!

It does not matter to me whether or not you like him or don't like him, all I can tell you is that he is a truly gracious & caring individual when it comes to how he feels about patients, and how his and the company's focus is on the patients. I cannot you how many Élan employees came up to me after my speech to not only meet me but how much they thanked me for everything I'm doing..., but again, it was me thanking them for everything that they're doing! Some of us exchanged e-mail addresses, some of us patients also exchanged e-mail addresses, etc.

Okay, I'm exhausted now, so I'll have to call it a day.

Hugs to all, and thank you everyone for your warm wishes, your thoughts and prayers.

All my very best to each and everyone of you, Lauren

PS: Oops, I forgot to mention that BAP was also discussed in a favorable light, and many researchers at Élan came up and told me that they are very excited about this medication and the implications that it will have on the Alzheimer's patient population..., a couple of of them also told me that they were working on a Parkinson's medication. Just remember that I am unable to go into great detail about our conversations because the live band was playing at the same time we were trying to talk and listen to each other, and that was very frustrating for all of us, but especially me because I can no longer talk very loud. I really, really, really wanted to visit more with Mr. Yednock, but it was almost impossible for either of us to understand what each of us were saying to each other (Argh!)

My Tysabri Diary.....,

Good morning everyone, I wanted to post a very short survey that is being conducted by my friend Stuart, and you can also answer these 4 short questions on his blog and/or read other comments listed by other Tysabri users.

Have a great rest of this week: (here is the link for Stuart's Tysabri Survey)

http://tinyurl.com/o27jrx

1. What did you want Tysabri to do for you?

2. What changes have you noticed since beginning Tysabri?

3. How long did it take for these changes to be noticeable?

4. For How Long have you been using Tysabri?

Here was my reply to his survey:

Hi Stuart,

Thank you for your follow-up "Unofficial Survey for Tysabri Users"..., this should help others tremendously if they are undecided about Tysabri therapy and/or others currently on Tysabri therapy can compare their experiences as shared on your blog by others. I have posted your survey (Link) on my blog so that others may view your survey,and comment if they choose. In answer to your questions:

What did you want Tysabri to do for you?

I was hoping that Tysabri would stop my relapses (or at least slow them down) and slow my disease progression.

What changes have you noticed since beginning Tysabri?

I have noticed that I have hope once again in my life, and I no longer fear waking up each day with the thought of "what has MS taken from me today?". My quality of life has greatly improved and I have a renewed positive view when looking at my future.

How long did it take for these changes to be noticeable?

When I was first on Tysabri therapy (before it was removed from the market for 18 months), within two weeks of my first infusion back in 2/05, I noticed that my right drop but was gone, my limp was gone, my optic neuritis in my right eye had completely cleared up, my slurred speech was gone, and my balance issues were just starting to clear up. I put away my walker and just used my cane for better balance.

Unfortunately, I suffered a severe relapse during the time that Tysabri was not on the market. I am now confined to a wheelchair, but since restarting Tysabri in 10/06, I have not had one single relapse nor any new lesions showing on my recent MRIs. My MS is now stable, woo hoo!

For How Long have you been using Tysabri?

I have been on Tysabri therapy for almost 3 years.

I hope this information is of some help to others, take care now..., ((((hugs))))
Love, Lauren :)

My Tysabri Diary...,

I had my 38th Tysabri infusion on Wednesday, 9/2. All went well as usual, no problems... yaaay!

I thought I would post a recent press release about Tysabri as follows:

http://newsroom.elan.com/phoenix.zhtml?c=88326&p=irol-newsArticle&ID=1330919&highlight=

Data Supporting Unique Efficacy of TYSABRI Presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

Which states in part:

"[Data] showing the potential of TYSABRI^® (natalizumab) to redefine successful multiple sclerosis (MS) therapy. These data were from observational studies and retrospective analyses of the Phase III AFFIRM clinical trial, demonstrating that TYSABRI:

• Significantly improves measures of physical and cognitive disability using the Multiple Sclerosis Functional Composite (MSFC) in patients from the AFFIRM trial with baseline impairment;
• Promoted regeneration or stabilization of damage to the myelin sheath, which can cause some of the symptoms seen in MS patients, as measured by advanced MRI technology; and
• Shows improvement in quality of life as reported by patients.

"MS patients should expect more from an MS therapy and studies such as these demonstrate the potential for TYSABRI to satisfy their expectations," said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology, Biogen Idec. “These data presented at ECTRIMS show that, for many MS patients, TYSABRI may lead to improvement in a broad range of physical and cognitive symptoms.”

“The strong efficacy profile demonstrated in clinical trials is enhanced further from these and other important TYSABRI data presented at ECTRIMS," said Carlos Paya, M.D., Ph.D., president, Elan Corporation. “TYSABRI is the first approved MS therapy with reported data suggesting some signs of the progression of MS can be stopped, whether measured by clinical, radiological or patient-reported measures.”

The data goes on to state the following, and details of the analyses is contained in their press release:

TYSABRI significantly improves physical and cognitive function

TYSABRI stabilizes and restores damage to the myelin sheath

TYSABRI patients report improvement in physical and psychological well-being

"TYSABRI is approved in more than 40 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS. According to data from the Phase III AFFIRM trial published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate, when compared with placebo, and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI is redefining success in the treatment of MS. In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSABRI-treated patients remained free of their MS activity, compared to seven percent of placebo-treated patients. In addition, data has been presented showing that treatment with TYSABRI significantly increased the probability of sustained improvement in disability in patients with a baseline expanded disability status scale (EDSS) score ≥ 2.0 by 69 percent relative to placebo."

Pretty impressive proven data, don't you think? (Smiling)

Oh I forgot to tell you all that Élan Pharmaceuticals invited me to come up to San Francisco and speak at their "Employee Day"..., pretty exciting for me! (They'll probably all be bored to death - heehee).

I'll report more when I get back home (I'll probably include this in my 39th Tysabri infusion report which will be on 9/30).

Enjoy your weekend everyone!

((((hugs))))

Love, Lauren :)

(heehee)

My Tysabri Diary..... ,

Hi everyone, I had my 37th Tysabri infusion yesterday, and all went well - just one stick and my infusion nurse got a line in - and after just five minutes of having a saline solution started, my Tysabri arrived in the infusion center and I got started right away, yaaay! The young lady that I spoke of in my last infusion report continues to do well, and none of us currently on Tysabri therapy where I receive my infusions are afraid of developing PML, so I've been told...., I wanted to share an article written about Tysabri, my reply, and two e-mail replies that I received from different MS patients currently on Tysabri therapy, one of the US, and one in Puerto Rico - I'm so glad tha Élan finally took some action against Biogen - I guess we will see what happens next..., enjoy your upcoming weekend everyone! Lauren

I have permission by both of these authors to share their e-mails..., the first is from an attorney that wrote to me regarding PML, with my replies; and the other is an e-mail that I received from the young lady in Puerto Rico that is singing the praises of Tysabri to everyone that will listen to her!

First the article and my reply:

http://www.medicalnewstoday.com/articles/159129.php

11th Tysabri Patient Develops PML

Main Category: Multiple Sclerosis
Also Included In: Neurology / Neuroscience
Article Date: 29 Jul 2009 - 3:00 PDT

Current Article Ratings:

Patient / Public:		3.6 (10 votes)
Health Professional:
Article Opinions:	3 posts

An 11th patient taking Biogen Idec's multiple sclerosis (MS) drug Tysabri has developed a potentially deadly brain infection.

In the latest confirmed case of progressive multifocal leukoencephalopathy, or PML, the patient took Tysabri for 29 doses, continuing the trend of the last six reported cases of the infection, where each patient had therapy for two years or longer.

The latest patient was located in the USA, the third American to have developed the infection. Of the 11 reported cases, one patient has died.

The PML incidence rate remains below the long-projected risk rate of one in 1,000 patients for those patients receiving the therapy for 12 months or 18 months.

The drug was temporarily withdrawn in 2005 after it was linked with PML, but was then brought back in 2006 with stricter safety warnings.

Tysabri continues to receive strong support from patients and doctors, however, because of the drug's perceived effectiveness. That support has remained steady because patients are made well-aware of the PML risk before they start taking Tysabri for MS.

This is the last case of PML that the company plans to announce on its website. In future any new cases will be reported by word of mouth to medical professional and patient groups.

Source
Multiple Sclerosis Society

My published opinion:

http://www.medicalnewstoday.com/youropinions.php?opinionid=40864

11th Tysabri Patient Develops PML

posted by Lauren on 29 July 2009 at 2:06 pm

This is probably one of the most unbiased, accurate, and well-balanced articles I've read to date as it relates to Tysabri and the possible link to PML. In addition, eight out of the last 10 patients (that we know of-excluding the latest patient) were all on very strong immune suppressants prior to Tysabri therapy (these included azathioprine, methotrexate, Novantrone/mitoxantrone, & IVIG therapy). It is unclear from the 6th & the 11th patients' past medical histories of prior treatments as they have not been made available to all of us.

Nevertheless, this is one of the most informative articles I have read recently with regard to Tysabri and the possible link to PML.

Lauren (MS patient for 34+ years and current Tysabri patient that recently completed her 36th infusion)

Subj: Interested in Your Thinking Date: 7/30/2009 6:22:06 AM Pacific Daylight Time From: To: LGLBGL2003@AOL.COM Sent from the Internet (Details)

Lauren:

Greetings. It was a pleasure to digest your blog and its entries. Excellent work. I have a few questions. But, before I go there...here is a little on who I am. As you can see from my signature block below, I am an attorney. Just what you need...another damn lawyer. At any length, I was diagnosed with Relapsing Remitting Multiple Sclerosis in April of 2008 and started Tysabri around June of 2008. I have completed infusion #15.

What may make my case of interest is that I have had no prior MS medications whatsoever. Also, my specific diagnosis is "mild" RRMS. Further, I am a real wimp when it comes to needles. I do not believe that I could self-inject, which made my decision easier to go with Tysabri. In fact, I had no hesitation to go that route since I am married and support not only my wife, but also my two children, and to a lesser degree, my former wife and my mother. Thus, being able to remain productive and actively employed are key goals of mine. (I am of Greek national origin and the teaching to me as child and in that culture was to sacrifice for family at the sacrifice to yourself. I am made form that cloth.)

My symptoms prior to my diagnosis included a "palsy" type numbness on the left side of my face that lasted 6 weeks, then numbness in my left hand, then an inability to feel the bottoms of my feet requiring me to look at my feet when walking to get feedback to make sure I was placing my feet properly. My first neurologist (who is the head of the Neurology Department at University Hospitals in Cleveland) was very conservative and did not do perform the ologloconal (sp?) banding test on the CSF despite my suggestion that he do so. It was not until I experienced significant imbalance (making me do the "wall walking") and complete double vision that he went forward with the CSF test. He managed to screw up the test because he did not draw the serum (i.e., the blood) from me within the required time in order for my blood to be tested for ologloconal banding. Absent that serum, a true clinical diagnosis could not be made. So, my diagnosis was "probable" RRMS. The neurologist sent home some literature to me on Avenox and Copaxone and asked that I read it and then call him in a week. In the meantime, I found a "real" neurologist, who is the head of the Mellen Center for MS, which is part of the Cleveland Clinic hospital system and, in my opinion, one of the best facilities for MS in the world. They are doing all sorts of MS studies, including stem cell therapy as part of research. My new neurologist told me about Tysabri,l where the prior one did not. (No I will not sue. Too much of that in my life.)

That is my story in a nutshell. Now, to my question. I am a big Tysabri believer. So far, it has been just over a year for me on Tysabri with no relapse. That is great. I have no symptoms form the infusion other than some very minor tingling in various places on my skin during the infusion. However, I am having a problem buying in to your theory, if I understand it correctly, that Tysabri does not cause PML. Rather, you opine that a compromised immune system causes PML, principally through the use of prior MS medications. If that proves to be true, then Happy Days are here because I have never had any form of MS medication other than Tysabri.

However, my understanding is that Tysabri itself is a compromise to the immune system by keeping those sneaky white blood cells from entering my brain. And, if Tysabri does compromise the immune system, then Tysabri can cause PML. I have read many articles connecting Tysabri to PML for this reason. Can you bring some illumination on where we have a disconnect?

By the way, I hope you do not mind my saying so, especially since I am a happily married man...you are beautiful. And, I cannot understand how a 54 year old paralegal can retire. I am 49 years old and may never be able to retire. How did you do it?

Thank you very much. I truly enjoy your blog. Cheers!!

XXX

Subj: Re: Interested in Your Thinking Date: 7/31/2009 10:32:38 AM Pacific Daylight Time From: LGLBGL2003 To: Right-click picture(s) to display picture options

In a message dated 7/30/2009 6:22:06 AM Pacific Daylight Time, XXX writes:

However, my understanding is that Tysabri itself is a compromise to the immune system by keeping those sneaky white blood cells from entering my brain. And, if Tysabri does compromise the immune system, then Tysabri can cause PML. I have read many articles connecting Tysabri to PML for this reason. Can you bring some illumination on where we have a disconnect?

Hi XXX, it is so nice to meet you! And it was such a pleasure to read your e-mail and your English composition skills are outstanding! Oh boy, do I miss reading such well-versed sentences, and your analogies therein. (Not only am I a Certified Paralegal, but I am also an English major-heehee). I honestly do miss reading my attorneys' trial briefs, and even composing some of them for him. But sadly, I had to retire early because I was starting to confuse & interchange "plaintiffs" & "defendants", and I would never place my boss in a situation where he could be sued for legal malpractice (he is a partner in a law firm, and he is one of the best trial attorneys in California). His specialty is ...defense and .... Although I have worked for "certified specialists" representing both the applicant and defendant, I became well versed in the litigation field. I would have absolutely died of embarrassment if I ever screwed up a trial brief for him. He is a very kind and understanding family man, and he was such a pleasure to work for (can you tell I miss the legal field?).

Now on to your question: yes Tysabri does prevent a majority of the inflammation cells from crossing the Blood Brain Barrier and entering the CNS where they cause our damage (lesions/symptoms, etc.), but Tysabri in and of itself does not cause PML, a severely diminished immune system can cause PML. This is why PML was mostly seen in patients with AIDS. I reference the following from the New England Journal of Medicine:

"... the emergence of two cases of progressive multifocal leukoencephalopathy (PML), a rare but deadly viral infection of the central nervous system (CNS) associated with immunosuppression. Owing to the effect of natalizumab on central nervous system leukocyte recruitment, the emergence of PML has been attributed to diminished immunosurveillance. The lack of additional opportunistic or CNS infections among natalizumab-treated patients, however, suggests that alternate mechanisms may contribute to the infectious risk.."...,

In addition, it is the activation and proliferation of the JC virus entering the cell tissues of the host which causes PML, not Tysabri. The JC virus is carried by 80% of the population, irrespective of whether they have MS or not. It usually remains dormant in the kidneys until it is activated by a compromised immune system that can no longer fight it and keep it dormant.

Lastly, in my opinion (and I am not a doctor), the immune system is very fragile and any attempt modulate it (with the various previous use of the ABCRs, etc.), or suppress it with the various strong immunosuppressant medications such as Imuran/azathioprine, Remicade, methotrexate, Novantrone, etc., whose a effects can last for years to the body, can cause serious damage when adding Tysabri to the mix, I believe can lead to eventual disaster for certain patients (i.e. the activation of the JC virus leading to the development of PML). You also have to remember that not all MS patients & their immune systems are alike, and some of them will be at a greater risk of developing PML (like the EU patients where Novantrone/mitoxantrone is commonly used & where the PML cases are higher in number), while a majority of us won't have any problems with our immune systems whatsoever (I also think that most MS patients have a very strong immune system, which is why we keep having relapses!). This is why I firmly believe that Tysabri should be used as a first line of defense against MS before any damage can become permanent. Kudos to you and your neurologist for choosing the most effective MS medication we have to date as a first-line therapy to fight your MS.

A portion of the above is only my opinion and thinking when it comes to my conclusions regarding Tysabri.

I'm so happy that Tysabri is working for you, and that your prior damage/symptoms have been reversed. Obviously, the following holds true as it relates to remyelination of previous nerve damage that you suffered due to MS: TYSABRI® Promotes Remyelination & Suggests Improvements In Symptoms .

Now XXX, I need to ask you a question..., your e-mail was so well written I would like to share the pertinent portions of same with others & with those that might also be sharing your views..., may I have your permission to do so? I will of course remove any personal information, including your e-mail address.

I won't do anything until I receive your response to my reply. Again, it was so nice to meet you, and I hope we can continue our dialogue regarding Tysabri.

All my very best to you and your family...,

Lauren

Subj: RE: Your Thoughts Date: 8/4/2009 12:55:11 PM Pacific Daylight Time From: To: LGLBGL2003@aol.com Sent from the Internet (Details)

Yes. I have been thinking about it. You know...I am a biased observer because I am hoping (OK—praying) that your theory is right. Like a lawyer, I must answer your question with another question. I can but into your argument, but can you explain to me why PML is not a risk for those persons taking Avenox or Capaxone? I believe that these are immuno-modulatory medications and it is an absolute no-no to take them with Tysabri. But to the question...why is there no PML risk for those two medications. I believe they suppress the immune system. Many people have been taking them for years. So, if you can sway me on this, I would be more apt to buy into your theory. Remember, I am praying that you are right. I would hate to be the living (or not living) example of you being wrong.

... Cheers!! XXX

Subj: Re: Interested in Your Thinking Date: 7/31/2009 1:05:40 PM Pacific Daylight Time From: LGLBGL2003 To: Right-click picture(s) to display picture options

...,

If I lived in Cleveland, Ohio and was not as disabled as I am - I would probably want to work for you.

I believe that Dr. Richard Rudick practices out there in the Cleveland clinic ..., did you know that he testified at the "Tysabri Hearings" before the FDA AC in March 2006? He was among only a small handful of MS specialists there were proponents of reinstating Tysabri to the market? I felt honored that I testified as well (although be it via videotape)..., he is such a great doctor!

Okay, I should let you go since you're probably at work right now (or maybe you're just goofing off on the job - did I just say that out loud? Oops,heehee).., have a wonderful weekend XXX!

Lauren

PS: thank you for the compliment on my picture in your prior e-mail, I forgot to thank you previously (that was either my aging brain or my MS brain, take your pick)

Subj: Re: Your Thoughts Date: 8/4/2009 5:21:57 PM Pacific Daylight Time From: To: LGLBGL2003@aol.com Sent from the Internet (Details)

A few things. Ok. I'm trackin' with you. First, I like calling them the CRABs. That sounds so much more creepy. Or, it can be seen as humorous. Hey I heard you got the CRABs dude. Dr. Richard A. Rudick is my Neurologist. One of my Partners is married to Dr. Rudick's nurse practitioner. That is how I was able to see Rudick. He is doing a lot of research, too. What a small world. I am at work, but I am smiling, which is pretty nice given that nature of the practice.

Second, try to keep it positive. Delight in the fact that we are alive! Maybe we are a little beat up, but damn alive nontheless.

Third, consistent with what I just noted, I would not count the dead. Yes. That is valuable information when considering medication options, but, once I made my mefication decision, I would then choose to suppress that information from my conciousness and defend my psyche against harm. I am told that us guys do that better than women. Of course, I am also told that women multitask better than men.

I am not preeching and I admit to being a hypocrit. I currently represent a funeral home in defending against an allegation that the funeral parlor did not bury the deceased with the casket of her choice. Let me tell you. Exhibit A, which is a picture of the deceased is overshadowed by Exhibit B, which is a picture of the deceased's husband in his coffin. Charming. I digress. XXX

One $ore thing. What do you mean, specifically, that they had a problem with their immune system. What peoblem and is it shown that these meds can cause such problems? Cheers.

Here was my latest reply to him:

What I mean is that I believe they already had a problem with their immune systems ( i.e., they were at the beginning stages of developing PML before Tysabri was even introduced into their systems, perhaps they already had compromised immune systems, perhaps the immune modulators altered their immune systems to the point where they became compromised, etc.).

Unfortunately, I cannot be more specific as I do not have all of the prior medical histories of the patients, nor am I a medical professional. I just don't believe that Tysabri was the cause of PML..., my main argument being why didn't PML show up earlier in the Tysabri trials (both the Affirm & Sentinel trials)? Probably because the trial patients were better screened, perhaps.

Lauren :)

Here is the e-mail from the young lady in Puerto Rico:

Subj: [Living With MS] New comment on My Tysabri Diary...Patient Advocacy Many of you m.... Date: 7/29/2009 4:54:14 PM Pacific Daylight Time From: To: LGLBGL2003@AOL.COM Sent from the Internet (Details)

Hey! Greetings from Puerto Rico. My name is Maria Elena, I'm 20 years old and I've been a MS patient since I was 15 years old. It's been pretty hard for me to deal with this condition, academic obligations, my social activites, my fights for medical coverage and life itself. I even lost my short term memory for a while (You should have seen my boyfriend's face when I told him not to kiss me because I didn't even knew who he was), but with treatments and all the protocol, I recovered it. I have 14 spots on my MRI pictures (12 on the brain, 2 on my spinal cord). Lots of people tell me that I'm too young, and yet, they admire me for keep on living (I tell you, it's not so sexy to wear Poise or Depend or not being able to wear other shoes other than my trustful sneakers, but I don't care, I gotta keep on living in spite of what others may think of me).

Currently, I'm using Tysabri and I feel as if I was the girl I used to be 5 years before. I feel way more confident and more happy. I have no idea why people, doctors and media are criticizing so much this wonderful medicine. When I first started filling out the papers for my first Tysabri, people asked me stuff, like: "Oh, my God! Do you have any idea of what you're doing?" and "But you're so young! Do you want to die?" But I stood up to them with attitude and clearly stated that this is my only chance to experiment an improvement in medicine, and if I should die trying to get better, I will die HAPPY, for I'm close to a healthy body, the one I used to have.

I'm getting ready for my 6th Tysabri infusion. The nurse will use a needle and I'll be there for an hour. I'll listen to other people's stories, critics and non-believable stuff. But when I get out of there, and I wake up to see a new day, I'll look at my face in the mirror and I'll know I'm in the right path, I'll know I'm fine and most of all, I'LL KNOW I STILL HAVE A LONG WAY TO GO. And I will not die because of my beautiful, perfect therapy. I'll die old by any other thing, but not by my medicine because my medicine is just perfect!

I try to pass on the message that Tysabri has helped me and other people so much, it's incredible. I would like to vanish those awful rumors about such a perfect medicine. This Friday, I'll have my 6th infusion and I really can't wait. I get excited about it, because I actually feel it's working. I used to have relapses around this season before, but this is the first summer I have felt so...alive! I'll tell everyone I can about your blog and how we all should comfort each other, because the weight of our situations is really heavy but there'll be people who can help us make this burden a little more bearable.

Thanks for everything and cheers to you, for you're doing a great job with your body and physical therapy (I don't know which exercises are you practicing, but this lets me know you're not giving up, so GO GET 'EM, TIGER!! )

Blessings from Puerto Rico to California
XXX

*That's my nickname. I told a friend of mine that I walked like a pinball ball, everybody laughed (me too) and that became popular among my friends. I even use it on my MySpace profile because it doesn't bother me at all! (How could it bother me? After all, I named myself that way and it made me unique in my school and everything)

My Tysabri Diary..., ever have one of those days????,

Hi everyone - I had my 36th Tysabri infusion on Wednesday, 7/8. All went well, no problems. I did find out that the young lady that just started Tysabri recently at my infusion center is doing really, really well according to my infusion nurse. Apparently, this particular patient is responding favorably and in a very drastic way to her Tysabri infusions. In particular, prior to her first infusion she was on the verge of progressing to the use of a wheelchair, but now after her third infusion, she no longer even uses a cane!

After sending various e-mails to Élan requesting information which had been omitted from the "Tysabri for Crohn's" page on Élan's website under the PML patients' past treatment histories (specifically, post marketing patients #1 and #6), I was finally contacted just this Tuesday by the person responsible at Élan for posting the information.

I had a lengthy telephone conversation with the Sr. Manager of Medical Communications with the Élan Medical Information group.

Now for the frustrating part & an explanation for my mixed feelings ..., She stated that because I am not a medical professional, she could not disclose that information to me, nor did they even have further information about patients #1 & #6. She then proceeded to tell me all about the FDA restrictions regarding disclosure and that I should speak with my neurologist if I want further information.

We went round and round and round and she had in her head that there was nothing wrong with the information posted there, and I emphatically insisted that there was notably incomplete information regarding past treatments for patients #1 & #6..., were they previously on monthly pulse steroids, IVIG, any kind of immunosuppressive therapies for other conditions, etc.? She finally acquiesced and said she would take a look at it, but if the patients' doctors do not advise Biogen/Élan of such therapies/conditions, their hands are basically tied because they cannot force the doctors to provide such information. I asked her if she would even discuss this with Biogen and send a follow-up questionnaire to these two doctors, and she never said anything. (first she states in her e-mail that she has additional information, and then she says she doesn't).

The information I am referring to is located on the www.elan.com website, and to access this information you must be a medical professional, and because the information is copyrighted, I cannot post the information here.

I told her that a doctor friend of mine sent me the information from their Tysabri/Crohn's website, and she said that was fine, but was significantly rattled when I was making the connections between these PML patients and prior immuno modulating therapies & immunosuppressive therapies as it related to the link to PML - and not the link to Tysabri.

So all in all, I'm not sure she will do anything if it becomes too much work for her. I am thoroughly exasperated and disgusted at this blasé attitude, especially from Élan. They really don't seem interested in promoting Tysabri (even though this is Biogen's contractual obligation here in the US) , nor do they seem interested in protecting Tysabri's good name..., oh well - I tried (sigh) Lauren .

In closing to my post here, we exchanged the following e-mails..., Here is her original e-mail to me:



Hi Lauren,

My name is Michelle XXX within the Elan Medical Information group, and I was forwarded your TYSABRI questions that you had initially sent to XXX here at élan. Thanks so much for bringing the inquiries about the TYSABRI PML cases to our attention. From my understanding, we do have data that we can share in response to the questions you posed [the bold is mine]. Typically however, our guidelines are to make sure that patients receive this type of medical information through their doctors, to allow for a better discussion with them, especially as they may tie into discussions about their own personal medical care.

So, what I would like to do is get in touch with your doctor as soon as possible and share some of the medical data that we do have in response to the questions you provided, so that he/she can discuss them with you.

For any other patients who have similar PML case questions, we would instruct patients to contact their doctors with questions. If their physicians do not have the answers, we are happy to provide them with the data that is available.

I would have loved to call you directly, but I don’t seem to have your phone number! If you would like to talk directly, please feel free to contact me directly. At minimum, if you would forward your physician’s contact information to you, I will let him know the questions you have brought up to us, and provide him information that he can then discuss with you.

Thank you,

Michelle

Hi Michelle,

Thank you for your e-mail. In answer to your questions below, please be advised that my doctor is not interested in becoming involved due to his busy schedule and for various other reasons even though I previously spoke to him about my two questions. Yet here again, the information that I seek is being withheld from me. I would have expected this from Biogen so that they can protect their Avonex franchise, but never from Élan.

In a message dated 7/6/2009 4:05:54 PM Pacific Daylight Time, Michelle.XXX@Élan.com writes:

I would have loved to call you directly, but I don’t seem to have your phone number! If you would like to talk directly, please feel free to contact me directly. At minimum, if you would forward your physician’s contact information to you, I will let him know the questions you have brought up to us, and provide him information that he can then discuss with you.

...,I am available today (right now as a matter of fact) for you to contact me.

For the life of me, I cannot understand what is so difficult about providing this information to me..., I am not asking for any names so there will not be a violation of those two patients' right to privacy..., you either have the information or you don't.

On the various MS forums that I visit daily, false information is being provided by God knows who to these patients that are having a difficult time deciding on Tysabri therapy. I cannot provide accurate information about Tysabri if I don't have any cooperation whatsoever from either Biogen or Élan.

Please call me to discuss the above which will not only help these MS patients which are confused about Tysabri, but whose doctors wish to keep them in the dark when you and I both know very well that they will probably benefit from Tysabri therapy and not have to needlessly suffer debilitating relapses, which could probably leave them disabled. Is Élan really that heartless & uncaring?

Sincerely,

Lauren Roberts

I then asked her to send me an e-mail confirming our phone conversation, and this is what I received:

Subj: Getting back to you regarding your request for TYSABRI PML information Date: 7/8/2009 10:43:57 AM Pacific Daylight Time From: To: LGLBGL2003@aol.com Sent from the Internet (Details)

Dear Lauren,

It was good talking to you on the phone yesterday. Thanks again for providing your comments and feedback to us about the PML case information you mentioned you were shown by a health care professional.

As mentioned in our phone conversation, we have a policy against directly sharing clinical data that goes beyond what is publically available or what is within the prescribing information for TYSABRI, with patients. If in the future, you would like to obtain TYSABRI clinical information beyond what can be shared with patients, this would need to be done through your prescriber, who we could provide information to if requested by the prescriber. I know you are not happy with that, however I believe we were able to come to an agreement as to why our policies exist.

With much respect,

Michelle XXX

As mentioned in our phone conversation, we have a policy against directly sharing clinical data that goes beyond what is publically available or what is within the prescribing information for TYSABRI, with patients. If in the future, you would like to obtain TYSABRI clinical information beyond what can be shared with patients, this would need to be done through your prescriber, who we could provide information to if requested by the prescriber. I know you are not happy with that, however I believe we were able to come to an agreement as to why our policies exist.

Dear Michelle,


Thank you for calling me Tuesday, 7/7.

As I mentioned to you, there is much false and misleading information posted on the different MS forums about Tysabri. Furthermore, not to sound conceited, but I happen to know more about PML and clinical Tysabri information than my own doctor because I have been studying Tysabri/Antegren since 2000, and it is absolutely ridiculous that any information I request should go through him first, taking up his valuable time.

And we reached no agreement whatsoever other than you saying you would take a look at your website (Tysabri for Crohn's) so that you could see why I have been emphatically insisting that there is notably incomplete information regarding past treatments for patients #1 & #6..., were they previously on monthly pulse steroids, IVIG, any kind of immunosuppressive and/or immunomodulating therapies for MS or other conditions, etc.??? I am not asking for names of these individuals nor is this invading their privacy due certain restrictions under HIPAA.

I completely understand if these patients' doctors choose not advise Biogen/Élan of such prior therapies/conditions and that you cannot force the doctors to provide such information. You can't even issue a Subpoena Duces Tecum to obtain this information unless discovery is needed for litigation purposes. I offered the suggestion that you discuss this with Biogen and send a follow-up questionnaire to these two doctors, but you really didn't seem all that interested.

When I was making the rational connection between these 10 post marketing PML patients and prior immunomodulating/immunosuppressive therapies as it related to the link of PML (not the link to Tysabri), you disagreed and stated there was a link of PML to Tysabri. I disagreed with you again, indicating that the expert authors of the New England Journal of Medicine published data that PML is caused by a diminished immune system [not by Tysabri].

NEJM - Conclusions re: PML

This is why disclosure of any prior treatments such as IVIG, Novantrone, methotrexate, Imuran/azathioprine, etc., even for other conditions such as rheumatoid arthritis, are so very important, and therefore a supplemental questionnaire should be sent to the doctors of patients #1 & #6.

Do any of the Novantrone, methotrexate, Imuran/azathioprine, CellCept, Remicade, Rituxan, etc. websites plaster PML information all over their webpages and product labels?!?!?? No, they don't!!! When is a label change for Tysabri going to take place so that it is in line with the other medications which have been linked to PML??? When is Élan going to step up to the plate and call Biogen into action?!?

And you think I am unhappy??? You're darn right I am unhappy!!! Obviously, Élan appears to be quite complacent and uncaring that MS patients around the world are allowed to suffer needless relapses and possible permanent disability instead of fighting for Tysabri to be used as soon as possible with all of its outstanding data released to date..., why? For what? It probably has to do with the almighty dollar, sad, really, really sad.

I am thoroughly exasperated and frustrated that Biogen (but especially that Élan) is apparently doing nothing not fighting to get the correct information out to "information hungry" patients. Telling patients to seek information from their doctors that are highly uneducated when it comes to Tysabri is like telling a thirsty horse to go and drink water from an empty trough. In my eyes, and in the eyes of many MS patients, this is apparently because no one really seems interested in promoting accurate facts about Tysabri to patients that are seeking this information (even though this is Biogen's contractual obligation here in the US), nor does anyone seem interested in protecting Tysabri's good name.

For example, one MS patient wrote to me indicating that their neurologist told them that Tysabri can cause brain cancer..., excuse me??? Hellooooo??? And you think that these uninformed MS patients should talk to their doctors who are also uninformed??? These patients unequivocally have the right to access accurate Tysabri information.

Regards from a very unhappy & sad MS patient because many of her fellow MS'ers remain uneducated about the wonderful breakthroughs of early Tysabri therapy and how they could benefit tremendously if; their damage from prior relapses is not permanent; and if only one person cared enough to fight the good fight rather than allowing them to be kept in the dark, confused, uninformed, and hurting needlessly by perpetuating inaccurate misinformation and untruths about Tysabri.

Lauren Roberts (MS patient for 34 plus years, and current Tysabri patient that just completed her 36th Tysabri infusion)

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 :)

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:

http://www.youtube.com/results?search_type=&search_query=Tysabri&aq=f

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

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 :)

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 :)

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 :)

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, Lauren

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 Am 23. April 2009 um 15:50 Uhr 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

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

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 :)

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 :)





(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

Lauren

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 :)

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

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

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

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 :)

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 :)

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 :)

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 :)

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

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 :)

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 :)

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 :)

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 :)

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 :)

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 :)

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 :)

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 - :)

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 :)

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 :)

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 :)

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 :)

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 :)

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 :)

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 :)

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 :)

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

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 has sped by

Now, we need to face 2008

There may be risks involved

We may need to face some roadblocks

So stay alert

Share time with friends

Jump over obstacles

With care

And caution

Face challenges

Remember to laugh

Cooperate

Discover

Make new friends (yikes!)

Above all, be ready for adventure

Stick together

And we will be able to go far

Very far

Well, not quite that far.... heehee

Always take time to smell the flowers

Don't forget to relax and enjoy

And never forget to love those dearest to you




Happy new year everyone! (please don't drink and drive)

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/

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 :)

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

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/

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

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 Trash
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

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

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! :)

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

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

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

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

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
A very proud member of www.MSpatientsforchoice.org

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

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 IDE