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:
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
- speech and vison changes
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.