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?
I have blogged about my experiences with MS drugs (Rebif, Avonex, Tysabri, Solumedrol and others) and have a few posts about stem cell research but I usually don’t write about all of the drugs in clinical trials or even all of the MS drugs approved by the FDA. I pay attention to it, but thanks to other great bloggers, I don’t need to be that source of information. That being said, if I read about a new drug or trial that gives me hope and makes me smile, I feel compelled to share!
So, here it is. Our friends at Biogen Idec have started what it believes to be the first-ever clinical trial of a drug with the potential to regenerate the fatty protective coating around nerves that gets damaged in people with multiple sclerosis. Can you say, remyelination? I understand this is just the beginning of a long process but I am overwhelmed that BIIB-033 is going into Phase 1 trials with the potential of giving me back my myelin!
“Biogen scientists hope to change the paradigm of treatment with this newer drug, by developing an antibody that blocks a new target called the Lingo-1 protein. By hitting this marker on cells, the company hopes that it will restore the body’s natural process of building a fatty protective layer around nerve fibers, known as myelin.”
Wow, Tysabri and the possibility of new myelin?! We love to complain about the exorbitant costs and processes of drug companies, (and often rightfully so) but in this case, I just have to say…Thank you Biogen Idec.
You can read the whole story here: Biogen Idec Advances first Regenerative MS Medicine
Clearly there are pros and cons to big pharma, where do you weigh in?
I like to drink green juice. I like the taste but I especially like how it makes me feel. I haven’t juiced in a while because I always crave it more in Spring and Summer. Juice is usually cold and in the Winter, I don’t want anymore cold. Today was an exception. Yesterday, I had my 33rd Tysabri infusion with my usual IV Benedryl to pre-treat. That usually wipes me out the day of my infusion and it often creeps into the next day, leaving me less than energetic for at least the morning.
Usually, I just suffer through it but today I wanted to fight it and see if I couldn’t turn things around earlier than most of my “day afters”. The juice worked! I feel better! I think it is because I thought it would work….and it did. That kind of positive thinking doesn’t work for me every time, but more often that not.
Thank you Green Goodness!
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.
Ok, enough talk for the week about Tysabri and PML. Yes, they are both pressing subjects and there are many other overwhelming things to talk about, but all you get from me today is a thank you to my husband. I have blogged a bit about him before but may not have included him in my treatment recommendations. (I don’t recommend him for anyone else, please find your own!)
His love and patience is more important in my MS healing than any drug or vitamin or exercise regiment.
The support from my friends and family is AMAZING, but the constant, daily, minute by minute, relentless support of my husband, Mark is the one part of my MS fight that has been absolutely essential. He does so much for me and has walked with me throughout this journey, so patiently, that I can’t imagine going it alone.
Three years into this crazy MS game and we are still trying to figure things out, but I know he is there for me even when I don’t ask. Even when I don’t verbalize what I need or how I am feeling, he is solving a problem or making me feel better. Admitting that I am tired or down or frustrated is challenging. Sometimes, he still needs to ask me ten times before I tell him that I am tired but when I realize that he NEEDS to help me as much as I NEED him to help, I ask for it. Thanks Babe!
Feeling Good and Moving Forward,
Courtney
PS. The whole time I am writing this post, the song running through my head is, Let My Love Open the Door. It’s another song to add to the “My Life Story” playlist. Come on! You know you are going to make a “My Life Story” play list.
What would be the top three songs on your “My Life Story” playlist?
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/
If you have ever cracked open a perfect walnut, you will understand why I love the phrase, “in a nutshell”. Everything is right where it should be, simple, a perfect fit.
So here it is, theRIDEproject in a nutshell….
A. I am going to donate $1,000,000 to the the Myelin Repair Foundation through photography sales of limited edition prints focusing on things that move. MS stops people from moving. TheRIDEproject stops MS.
B. therideproject.com will be live the beginning of September and will include: my blog (reinvented), more resources for you, information on the ride project bike team, how to join or start your own team and raise money for the MS Society.
C. I will be sharing new, really cool cycling images to start, with more images coming from the surfing, skiing, maybe even horseback riding world. Yes, you can buy these images or tell your cycling enthusiast friends about them.
D. You will be able to track how much money I dontate to the Myelin Repair Foundation and learn more about the organization and their research model and updates at the ride project website.
Questions you might have:
Why are you “reinventing” your blog? For almost three years I have written to you about ME, about MY diet, about MY MS, about MY relapses, MY struggles, MY successes. Blogging has been invaluable to my MS journey and will continue to be an intergral part of my constant search for balance and wellness. I am so grateful that you have indulged me and connected with me. Thank you for picking me up when I was down, for challenging my ideas and supporting my crazy ways! Now, I want to give YOU things that you can take away and use in YOUR journey. I want to offer helpful information for MS patients and anyone that wants to live a healthier life. You don’t need an MS diagnosis or another disease to know that you are not healthy.
How will the ride project help to find a cure? By supporting an organization that takes a new approach to finding a cure. “The Myelin Repair Foundation is the only research organization that addresses every phase in the drug discovery process, from initial research all the way to licensing by commercial drug developers. This is the only way to ensure that promising research results in real patient treatments – in the shortest amount of time. We combine this holistic approach with our renowned scientific team and collaborative research model.” Read more at the Myelin Repair Foundation.
Tysabri works so well for you, do you really need “a cure”? Yes, I NEED a cure, You NEED a cure, and generations to come NEED a cure. When I was first diagnosed, I remember hearing, over and over again, “You are so lucky, 15 years ago, there wasn’t even treatment for MS”. I do feel lucky and so grateful that there are options to treat MS, and I thought that was enough but I want more. We deserve more!
What can I do to help make theRIDEproject a success? There are so many ways that you can help, but most immediately I need your input. Please, tell me what you think. Ask questions. Send great ideas. Challenge me. And, most importantly, be the cure you are waiting for.
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.
