Wednesday, I had my 14th Tysabri Infusion.
I am sure you’ve heard that two more cases of PML have been reported. I am sure you have heard that Biogen’s stock dropped dramatically. In fact, from most articles that I have read, I know more about the financial status of Biogen Idec than I do about the people, the men that have contracted PML. I get that pharmaceutical is big business but let’s get real and think about what this means to Tysabri patients and to the men who have PML.
I am sure more information will be released but due to patient confidentiality regulations we may never know the whole story. What are these men going through? What are they thinking? How has their risk vs. reward conversation changed? How are their families? Will they survive PML?
The first patient (case #1) was diagnosed with PML after 17 months using Tysabri as a monotherapy with no prior history of disease modifying drugs. He has undergone five rounds of Plasma exchange. No studies have been done, but it is thought that getting Tysabri out of the blood stream may help with further PML progression. He is “at home and ambulatory”
The second patient (case #2) was diagnosed with PML after 14 months of using Tysabri as a monotherapy with history of prior disease modifying therapies including azathioprine and beta-interferons is undergoing plasma exchange but I don’t know when or if it already happened. He is hospitalized.
For more info, see the official report filed by Biogen Idec:
http://www.sec.gov/Archives/edgar/data/875045/000095013508005223/b714958ke8vk.htm
I participated in a teleconference hosted by Biogen Idec yesterday. Dollars and cents were never mentioned. At the time of the conference, Biogen Idec had contacted over 10,000 Doctors, by phone to tell them about the two new PML cases. They also held this teleconference to get the word out to Tysabri patients. There was a doctor on hand to answer medical questions and Biogen Idec staff to answer other concerns.
The information was basically a repeat of what is out online but it was interesting for me to hear the following from a Biogen Idec rep: “We expected more cases of PML”. I guess I knew that. After all their claim is that the risk of PML is 1 in 1000. However, I convinced myself that because no patient had ever contracted PML using Tysabri as a monotherapy, that no one ever would. Biogen Idec confirmed that they would not voluntarily pull Tysabri but discussions were underway with the FDA. Someone asked if they could tell which way the FDA was leaning and the Doctor responded(with a sense of humor), the FDA doesn’t show much emotion over the phone so it is hard to tell.
The question I asked in an effort to stay in my own little risk free reality was: While Tysabri is a common link with these two patients, isn’t it possible that it is not the cause of the PML?
Answer from the Doctor – Tysabri is the cause.
I also asked: Even if you are not having symptoms, is PML clearly identified in an
MRI? – Answer from the Doctor – it has not been proven that PML can be picked up on an MRI.
(Funny, I thought that was one of the reasons I was having frequent MRIS). Both of these cases were detected through clinical observations and then confirmed with further testing.
What are the symptoms of PML?
- subtle weakness in the hands or legs
- difficulty thinking or concentrating
- a lack of coordination
- headaches
- speech and vison changes
- seizures
I know! These are just like MS symptoms! Knowing that, if you are on Tysabri and have any of these symptoms, don’t second guess yourself. Check them out with your Neurologist.
One question I wish I had asked is how do you test for the JC Virus. From what I understand (and I am no doctor) the JC Virus has to be in your system to get PML. From the online research I’ve done, there is no test for the JC Virus. I am going to ask my neuroligist but if anyone has more info, let me know.
The news of two new cases of PML is hard to hear. I think we need to prepare to hear about more cases. 1 in 1000. That is my new risk reward reality. Knowing that, how has my risk reward conversation changed? It hasn’t. Yes, it sucks that I even have to have conversations like, “Would I rather risk a rare brain infection or spending my life immobile? Would I rather be blind or have acute liver disease? Would I rather stay on interferons and spend 3-6 days a week walking around like the living dead or spend a day a month being infused with what I hope is my miracle drug?” but that is my reality. I hope more than anything that I have a choice and the choice is not made for me.
For now, I choose hope.
My 15th Tysabri infusion is scheduled for August 27th.
No Time for MS 
From everything I have read about you over the last several months it sounds like you are doing great things with diet and excercise. If Tysabri gets pulled could you just do yoga and eat well and not take any drugs? I am feeling naive about this whole thing because I am not on any meds and I feel fine. Am I failing to grasp why people take drugs for their MS? Please help me understand more.
Thanks so much,
Nadja
P.S. I hope this does not come across as insensitive.
my opinion of tysabri hasn’t changed at all. i’m just fearful about getting continued access to it. on friday i got a call from the infusion center that my appt on monday was cancelled, all of the neurologists had pulled their patients’ prescriptions. that was the first i heard of the new cases. i freaked out about the possibility of not getting the tysabri. it turns out i have to go see my doctor before they’ll let me have my infusion, but i’m assuming as long as the FDA doesn’t pull the drug my doctor will let me take it.
i’m sorry for the men who got PML and their families, but biogen couldn’t have been any more explicit about the risk of contracting it. those of us on it made the choice to use it anyway, and if we lose the PML lottery, we have to accept the consequences of our actions.
neither betaseron nor avonex worked for me. i don’t have the luxury of walking around like the living dead. i believe that without tysabri i have a better than 50% chance of being seriously disabled within 5 years. i’d rather risk PML, even if it were a 1 in 100 chance.
we have to make sure that they don’t make the choice for us. i’m not leaving it up to hope.
Hi Nadja,
I don’t think your comment is insensitive at all. We are all trying to get through this together! While I believe that Yoga, exercise and diet helps me feel great, I know the following:
After ten years, 50% of untreated relapsing-remitting MS Patients progress to Secondary Progressive MS. After 25 years, 90%. I blogged about this when I was just diagnosed: Why Avonex? #10
and still believe that MS need to be part of my plan for long term success. I don’t suggest that this is the right path for everyone and often consider the alternative but with all I know, I feel I am doing the right thing.
I was afraid to go on Tysabri because of the risk of PML, once I got over my fear I seriously prepared to go on Tysabri.
After reading what would put you at high risk for PML, Tysabri was not for me. The way I see it, there are risks in every medication we take Tysabri is no different.
Wish you continued success on your therapy choice.
as a neurologist who treats many people with MS, i believe that for most people with MS treatment options must be individualized based on many factors, Tysabri may well be the most effective available therapy to date. Although the risk of PML is very real and very small, the likelihood of real disability from ineffectively treated illness is more real and very significant. If i had MS, undoubtedly the first medication i would want is Tysabri.
Yes, you can test for PML–both a blood test and a spinal tap. Before I was put on Tysabri my doctor not only did the required MRI but also had my blood tested for the level of JC virus DNA.
I wanted to comment on testing for the JC virus, I was told they can test you when you have a spinal tap. But I also have heard many of us have the JC virus and it is inactive. It may not be this simple because it seems like a person with the JC virus should be ruled out as a candidate for tysabri…
Do any of you have children? I just had my 29th infusion of Tysabri and I am scared of PML. When I started getting Tysabri we where under the assumption that as long as you kept it as a momotherapy yo would fine. That has all changed and the death vs disability issue is a big one for me.
Angie, I have a 13 year old daughter. Chosing MS therapy is tough as they all have risks. How are you feeling? Has Tysabri helped to slow your MS progression?