There has been much speculation about whether or not there is a test for PML or JC Virus. I participated in a teleconference with Biogen Idec and a Biogen Idec neurologist and learned that there is not a test available for PML or JC Virus. This means that anything you have seen on Facebook or other internet sites about patients testing for JC Virus is simply, not true.

There is however, a trial for current Tysabri patients looking for JC Virus Antibody. (If you have the antibody, you have had the JC Virus) This test is available to ALL Tysabri patients registered with a Touch center (if your touch center chooses to participate).

Questions I had for the neurologist: When will this test be available commercially? There is no specific date but the test will not be available until the current trial is complete and results deem the test helpful in accessing PML risk based on the presence of the JC Virus Antibody.

As a research participant, will I be privy to the my personal test results? Yes, your neurologist will receive your results and can share them with you.

Here is more information about the trials:

In March, 2010, Biogen Idec and Elan began enrolling patients in two clinical studies, STRAFIFY 1 and 2, to evaluate the potential clinical utility of a blood test that is designed to detect antibodies to the JC virus. These studies are intended to define the prevalence of serum of JC virus antibody in patients with relapsing MS receiving or considering treatment with Tysabri and to evaluate the potential to stratify patients into lower or higher risk for developing PML based on antibody status.

The only thing that I am not completely clear on is if the trial is open to all MS patients who visit a neurologist with a Touch Center or only to Tysabri patients. I will clarify asap!

Questions?

Most assume that Tysabri DOES cause PML, but recent findings suggest otherwise. Lauren, my Tysabri warrior (really, if you want to know anything about Tysabri, this woman knows her stuff!) recently posted this, based on an article recently released by Elan.

Lauren believes (and so do I) that the cause of PML is not Tysabri but starting Tysabri when already immune compromised from other drugs like Methotrexate, Novantrone and others. You can read the entire Elan article here.

Based on the overwhelming benefits, would you start Tysabri if  you knew that you were not at risk for PML?

Check out my latest blog crush. I heart tsj photography.

I won’t be changing my Tysabri protocol but there is a new study delivering Tysabri by Sub-Q injections.

Take a FREE Financial Peace University Class from Dave Ramsey. I signed up!

I am thinking about going sugar free. Maybe I will try these seven steps.

Before I give up sugar, I would love to try a caramel marshmallow from Whimsy & Spice.

Happy weekend…don’t forget to spring forward!

This is one of the best articles I’ve read about the state of affairs with Tysabri. It is factual and thoughtful in it’s presentation of current events and options for moving forward.

Tysabri
Breaking News

The Facebook group, Tysabri: As long as my body tolerates it, I’m not scared of PML!, may have a somewhat casual title, but it addresses a very real concern in the MS community: Tysabri and the risk of a brain infection—PML (progressive multifocal leukoencephalopathy)—that it poses. Biogen Idec., the co-marketers of Tysabri, recently announced that since the FDA approved the therapy in 2004, there have been 24 cases of PML, including 4 deaths. This announcement has brought to light a number of questions and concerns regarding Tysabri, many of which Dr. Vollmer will address in this article.
After first receiving FDA approval in 2004, Tysabri was pulled from the U.S. market when it was linked to three cases of PML. In 2006 it was returned to the market after the safety profile was further explored. Tysabri works by blocking the passage of inflammatory immune cells through the blood brain barrier, thus slowing the progression of MS. The risk of PML is related to the fact that Tysabri may, in fact, work too well. For most people, the immune system would fight off PML without any difficulty, but because Tysabri is designed to fully block the MS immune attack on the brain, it also blocks the immune system’s ability to fight infections in the brain, such as PML. It appears, however, to have little if any problematic effect on other types of infections.

To read the rest of this article go HERE.

The Rocky Mountain MS Center is a patient-centered organization dedicated to changing the way we think about and treat MS in order to protect the futures of those living with the disease.

There are currently 24 reported cases of PML in Tysabri Patients. Four people have died. 1/3 of the total cases are from the US. Biogen Idec stopped reporting individual cases of PML on their website in July. At the time, there were 13 cases reported and recently the 11 new cases were reported. Many are outraged about this lack of disclosure. In my opinion, this wasn’t a smart smart PR strategy, but don’t believe it was a cover-up or an effort to hide the new cases. AND, it didn’t change my mind about anything.Tysabri is still my best option until something better comes along.

When I was taking the birth control pill, I never got monthly updates about the number of patients who had strokes or blot clots or died and didn’t expect that. I have to believe this is a similar story with other drugs, so why is the Tysabri – PML connection so sensationalized? Or is just because I am more aware of it that it seems like that?

I met with my Neurologist yesterday and confirmed that the incidence of PML is more frequent after 24 Tysabri infusions and there may be changes on the horizon, including a label change for Tysabri indicating that risk, and drug holidays or other protocol changes if necessary. I also learned that now that we have more information about the 24 PML cases, there are ways to more carefully screen patients for PML risk. There are several things involved including IGG Subclass 1-4 testing and JC Antibody testing. Eventually, this could help not only patients currently takingTysabri assess their risk but also new patients considering Tysabri.

Ask your Neurologist about the research that is going on and being planned to better screen for PML risk. Tysabri is the most effective DMD out there for MS. Get the facts. Do not make your drug choice based on fear. If your Neurologist doesn’t know the answers or is not familar with Tysabri, it is ok to get a second opinion. Get the facts and then make the desicion that is best for you. There is great information online but there is also very skewed information, especially on message boards. I find in many cases that employees from other drug companies will comment with inaccurate information in an effort to fuel the fire and increase the fear. If I read something online that I question, I bring it to my Neurolgist’s office and ask an expert.

Hysteria and panic only leads to hysteria and panic. (I think we have seen that demonstrated with H1N1). Educating ourselves, and making thoughtful decisions when it comes to our health and quality of life is essential.

Feeling Good and Moving Forward,

Courtney

After three hours at the infusion center for my 28th Tysabri infusion, and a really long nap, I am ready to think about anything besides MS.  If you need a  distraction from MS, a frustrating work day or anything else check out:

http://kwentzell.blogspot.com/

(beautiful paintings from a very talented artist and inspiring friend)

and

http://colormekatie.blogspot.com/

I had my 27th Tysabri infusion on Wednesday.  I typically have my infusions in the morning and then take the afternoon off and go to sleep early.  I typically wake up feeling either ready to go or almost ready to go!

This past infusion, I was scheduled for late afternoon. I didn’t get home until after 6pm. When I woke up Thursday, I was draaggggging! I need more recovery time from the infusion and will aim to always have a morning appointment.

I was looking through a journal that I kept when I was first diagnosed and taking Rebif. I am sure my blog entries from that time are similar but wow, it was rough! While I tried to stay upbeat, the side effects that I experienced made it tough.

Some of the things I said:

“Rebif Sucks – Enough said!”

“I felt too tired to go for a walk”

“MS is here today, Tingly face and right arm are an annoying reminder”

“With a Rebif hangover, the hike was really hard”

“Headache and Neck Pain kept me out of work most of the day”

“I am shaking inside”

“Anti – Nausea Meds are kicking in”

“I feel drugged”

“I want to disappear and forget about everything. Forget about a positive attitude, forget about fighting, forget that my neck hurts, forget that my head hurts, forget I am tired, forget that there is a needle in my arm”

In between all of those observations were things like:

“I had a great massage today”

“So glad the weekend is here”

“Went to a football game, it was a blast”

“Getting up early tomorrow to ride”

“Had a great early morning walk with Mark, Bailey and Guinness”

“I am scared but will fight.”

“I will find a way to be healthy and strong so I can raise her to be healthy and strong”

“Tysabri is the answer if I don’t want to be sick anymore” – Sept. 15th 2006

“I am fully responsible for my own great health. My daily habits create my great health”

“I feel amazing and hopeful”

While I don’t have to live with the horrible side effects of Interferons anymore, I do sometimes have bad days or a bad attitude.

The good stuff far outweighs the bad….then and now.

Today was Tysabri infusion #25.  I am tired but hopeful that this will be another great month. I feel lucky to have had the opportunity today to be infused. Not only am I fortunate enough to afford this very expensive drug but I am also so lucky that I work with Neurologist who knows that Tysabri is my best hope on the medication front for staying healthy and free of MS relapses and other issues.

I am also so grateful that with help from my family and friends, I can recognize when I am out of balance and need to re-focus and re-prioritize. Thanks to the caring people in my life, I am myself again.

I am pleased to announce that:

A. I tested negative for antibodies
B. Wednesday, I had my 23rd Tysabri infusion
C. I have yet to have any reaction except for mild mild mild stuff

Hearing about my test results was a dream but I knew I still had to convince my neuro to infuse. After discussing the options (no good ones), the positive effects of Tysabri in my experience and the fact that I was willing to put up with a week or two of my reaction symptoms, he agreed to move forward. He suggested a small dose of Solumedrol and I suggested NO dose of Solumedrol but agreed to consider it if I had a bad reaction.

I feel positive that my infusions will become easier and easier to handle.

So what changed?
For the past six months, my job has been tough, especially so in the past three months. That of course leads to stress, which leads to fatigue which leads to eating poorly which leads to not enough energy to exercise which leads to stress and so on and so on.

Somewhere in my mind, I must have been thinking that I could endure the stress and things that followed because Tysabri would protect me. My body on the other hand is fighting back and saying, “If you want me to handle this very powerful drug, you have to fight too”.

Now, Y’all know I am a fighter and that I know better than to work too much and to eat ice cream but I was so wrapped up in the craziness of things that I got lost. Even now, that I recognize it, I know I am still a little lost but coming out of it.

The best part is that today, I feel more like myself than I have in many months.

More to come on the diet changes I made before this last infusion and my favorite green juice recipe!

All MS drugs come with side effects and reactions. While the side effect of Tysabri that seems to have the most attention is PML, it is more likely that you may experience something that is less severe or nothing at all. If you read this blog regularly, you know that I often think of and talk about Tysabri as my miracle drug. Tysabri rescued me from a year of interferon hell and offered me hope for fewer relapses and to slow my MS progression.

Do I still think Tysabri is a miracle drug? YES

Do I still know if Tysabri is MY miracle drug? NO

I have had 22 infusions and from infusion #2 I have experienced infusion reactions. 2-4 were pretty severe and then, things got much better. Number 20-22 have been tough. I didn’t blog about it as I have been going through it over the past several months for a few reasons that I will get to later. My typical reaction includes not only fatigue (which could be from the Benedryl) but also chest pressure and pain that creeps up into the sides of my neck. You know when you drink a frozen drink to fast and get “Brain Freeze”? It usually feels like that, but in my chest, not my head. This reaction typically lasts one or two days at the most but recently it has lasted as long as three weeks.

Even with this reaction, I would choose Tysabri over Interferons. Unfortunately, I may not have that choice. After my last infusion, even with pre-treatment of several drugs, I still had the reaction. My neurologist insisted on an antibody test. I am generally opposed to an antibody test and refused the month before but this time it was test, or no infusion.

Tomorrow, I will get the results I am positive or negative. If I am positive, then I have reached the end of my Tysabri journey. If I am negative, I may have an opportunity to convince my neurologist to give it another try.

I didn’t blog about this because I needed time to experience it, address it and think it through it before sharing. I don’t have the answers yet. Without Tysabri, the first thing I will look at are lifestyle changes. The second will be other drug options.

Will post more tomorrow…