Last week I posted a Tysabri-related update indicating another Tysabri user (this time in the United States) has died from PML complications from taking the drug. While each death is scary and unfortunate, it’s important to note that we’re still well under the manufacturer’s “predictions” that 1:1,000 patients will develop PML after taking Tysabri. To date the ratio is closer to 1:5,000. Still, even one death is too many from a drug that seems to be providing great relief and even greater hope to those with M.S.
If individuals do have to die, the least we can do is learn from their misfortunes. So why is everything surrounding these patients’ deaths so secretive? In visiting the M.S. message boards this past week there is much speculation about this most recent death and the earlier deaths in Europe. Individuals have reported discussions with neurologists who have said that the most recent patient was on chemotherapy prior to taking Tysabri and even though she went through a six month wash out period it’s possible the prior treatment may have remained in her system and may have contributed to the fatal brain infection. If this is true, even a patient deemed to be using Tysabri as a ‘monotherapy’ may still be at risk depending on prior treatments and time frames. Isn’t this important information to share with Tysabri users?
It’s also been rumored that the patient was on Methotrexate for Rheumatoid Arthritis (for a full year) and other traditional M.S. injection therapies prior to the start of Tysabri, again perhaps without a sufficient wash out period. A discussion about this rumor, posted on a message board, seemed to frighten another young woman who is on Tysabri and was previously on Cellcept (another strong immune suppressant drug like Methotrexate) immediately prior to starting her own ride on the Ty-Train.
We all know that the original deaths attributed to Tysabri were from patients who were severely immune compromised and on other treatments (primarily Avonex) while also on Tysabri. But since its original recall and then reintroduction to the market, patients have heard little, specific details about additional patients who contracted PML.
Wouldn’t the details of their individual cases help those of us who wake each day worried that we’re experiencing the early symptoms of PML vs. just ‘traditional’ symptoms of good, ‘ole M.S.? Without the real information, I meet each new death with my own checklist. Chemo? Nope, haven’t had that. Avonex? Nope, safe there, too. I’ve never been on a drug for R.A. I’m AIDS-free. I haven’t had a cold or the flu, or much past the sniffles for over 18 months. I guess that means I’m not that immune compromised.
But, what if we find out that someone on Copaxone in the two months prior to starting Tysabri, particularly someone who had an awful reaction to the traditional member of the CRAB treatment family, dies from PML while on Tysabri? I’d likely stroke out. No kidding. So, what must others who were on Chemo, Methotrexate, Cellcept, Avonex or other treatments feel like when a new death – and the unsubstantiated rumors surrounding the death – is announced?
The Touch Protocol program, a requirement for any American on Tysabri is all about clinical vigilance. I would suggest that we find a way to be more forthcoming with the cases of PML that do develop in individuals taking this possible ‘wonder drug’. Yes, a certain level of patient privacy is important, but learning from these individuals and their personal histories with drug treatments may eventually save another life. This is one way to ensure that these heroic, M.S. patients didn’t die in vain.
Posted in tribute to this very brave woman, may she rest in peace…
Personal note: As one who ventured onto the “Ty train,” I found this to be a very emotional read, clinical in nature and without feeling (as required).
http://content.nejm.org/cgi/content/full/353/4/369
~HappyPoet
For clarity: The woman described in the Case Report is not the same woman who recently died from PML (I believe sharing the Case Report helps shine a bit more light).
~HappyPoet
Kim,
Thank you for posting this. Coming from a Tysabri patient who is seeing positive benefits gives the question more weight and validity. However, the source of the question shouldn’t really matter when the ultimate benefactor is the MS patient population at large.
I wrote something in response to a ‘news story’ not long ago (and before the US patient had died) – http://www.healthcentral.com/multiple-sclerosis/c/19065/51702/tysabri – I have similar concerns that you do.
It’s not likely that I will ever use Tysabri, due to extensive Methotrexate use for my Rheumatoid Arthritis. I’ve already been using it for almost two years and only plan to stop if I decide to try to get pregnant someday.
What the drugs companies perhaps do not realize is that sharing knowledge and openness are excellent tools for softening patients’ fears. And if Biogen/Elan want to continue with this “patient-driven” marketing scheme, they really need to start providing balanced information to those patients they expect will tout Tysabri by word-of-mouth.
Just my humble opinion. Thank you again for writing this.
Lisa
What a great and timely blog entry. You motivated me to call BiogenIdec Invester Relations (left a message) and MSActiceSource to stongly relay that they need to pass on more information on all the PML cases and their outcomes to the Tysaberi patients. I’ve been on Tysabri two years. I’m not scared by these cases but more information might put me more at ease and possibly let me help my doctor/infusion nurses in early PML detection if that should ever happen. I know how I’m doing every day where they only see me once per month/every 6 months.
While BiogenIdec is doing the right thing in announcing these cases and sharing the information with our Neurologists, this stovepiped communication of information does not work in the “Google” world especially with the press’s (probably mostly the financial press) hang-up on the Tysabri risk since the drug was voluntarily pulled from the market. An un-informed patient “Googling” Tysabri might be scared to death. The FDA regulates what the drug manufacturers can say about a drug. Maybe the press needs to get reigned in a little bit also.
Chris
The other point not mentioned with these 4 PML cases is that 3 of the 4 confirmed cases have occurred in Europe. This seems unusual given that 60% (19500 out of 35500) of the patients on the drug are in the US under the TOUCH program. Europe does not have the TOUCH screening for initial use of the drug nor the monthly checklist prior to infusion. Maybe just random chance but maybe the TOUCH program provides further risk reduction.
You make an excellent point!
Remember the FDA strictly regulates what manufacturers can communicate directly to patients. If your neurologist is not knowledgable enough or willing to answer all your questions I would strongly reccommend you find one who is.
Regarding the most recent tysabri death in the USA. It is my opinion that Biogen or perhaps the TOUCH Program needs to notify those of us who are taking Tysabri when a new case of PML or death due to PML occurs in a Tysabri patient. It is important to tell us what the medical circumstances where wherein the patient contracted PML. Was the patient using combination meds, or immunosuppressants, steroid use, etc. I am not recommending that privacy guidelines be ignored, only that tysabri patients be informed. It is in our best interest in order that each of us may make an educated decision to stay on Tysabri treatment or discontinue it. TOUCH’s complacency to alert patients of new cases of PML along with pertinent information leaves us in the dark. How can a program that mandates each of us meet criteria in order to enter into and stay in the program share no responsibility to inform us of risk. Afterall was not the TOUCH program’s established with the intent to provide risk reduction?