Living With MS

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

Thursday, August 06, 2009


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:

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: 4 stars

3.6 (10 votes)

Health Professional: not yet rated
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The drug was temporarily withdrawn in 2005 after it was linked with PML, but was then brought back in 2006 with stricter safety warnings.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.

Multiple Sclerosis Society
My published opinion:

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
Sent from the Internet (Details)


Greetings. It was a pleasure to digest your blog and its entries. Excellent work. I have a few questions. But, before I go 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 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!!

Subj: Re: Interested in Your Thinking
Date: 7/31/2009 10:32:38 AM Pacific Daylight Time
From: LGLBGL2003
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...,


Subj: RE: Your Thoughts
Date: 8/4/2009 12:55:11 PM Pacific Daylight Time
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
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!


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
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
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

*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)