Biogen-Idec's Tysabri Problems May Be Fault of European Doctors
Hard and fast data confirms that from July 2006 (when Tysabri marketing resumed) to September 8, 2009, thirteen worldwide cases of Tysabri-related PML occurred in patients being treated for MS with Tysabri monotherapy. Of these, only four cases were patients in the United States, according to an FDAPost-marketing Drug Safety report.
Germany is an important MS market for Biogen. Aside from the U.S., Europe is home to four of the top seven markets — Germany, Italy, UK, and Spain — in terms of commercial dollars spent on disease modifying drugs for use in MS, according to an analysis of the global MS market by the pharmaceutical research outfit Visiongain.
Patients receiving monthly Tysabri infusions in the U.S. must be enrolled in theTOUCH Distribution Program overseen by Biogen, which involves (i) extensive monitoring of all patients for signs of PML and (ii) education of all patients and providers, with strong emphasis communicated to all parties that the drug is contraindicated for use in MS patients taking any drugs that may increase their risk of opportunistic infections, including drugs that lower immune function (e.g., azathioprine, chemotherapy, cyclosporine) or immunomodulators, such as the interferon-based disease-modifying therapies.
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By the way - for those who often ask why I am not doing Tysabri, you all should know that I want to. It's my wife that needs further convincing.
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2 comments:
"Patients receiving monthly Tysabri infusions in the U.S. must be enrolled in the TOUCH Distribution Program overseen by Biogen, which involves (i) extensive monitoring of all patients for signs of PML and (ii) education of all patients and providers..."
LOL! Yes, patients receiving Tysabri infusions in the US must be enrolled in the TOUCH program. But "extensive monitoring" for signs of PML definitely is not in place (at least not at the three TOUCH-approved infusion centers I've been to) and while the neurologists I have dealt with are very educated about Tysabri, the nurses actually doing the infusion don't seem very educated about the drug.
The TOUCH people send the Tysabri product insert to the patient every month. At the infusion center, the patient is supposed to be asked 3 questions at every infusion. In five US infusions, over 3 different centers, we were asked these questions only once. That said, the questions are pretty simple, "do you have any new medical issues?" "do you have a weakened immune system" "have you had steroids?"
I feel that the TOUCH program exists simply to know when and where PML accidents happens...not to help prevent them.
All that said, Tysabri has really helped my daughter and I am grateful. But to think that the TOUCH program is making it safer for patients is a stretch.
Laura
When it comes to treatment with Tysabri or any other drug, it is the patient who must be most vigilant. You need to understand what your responsibility is in the whole picture. Anyone who does not educate themselves on what drug they are doing, why it is the drug they are doing, and what the consequences of using that particular drug are is not a participant in their own health care, but a disinterested onlooker.
If your infusion center is not following the required protocol, open your mouth. Ask questions, complain, call Biogen, ask other patients to do the same. The TOUCH program is simple, and it's required. There are FOUR questions you should be asked before every infusion. There is a booklet you should be handed before every infuaion and it is required that you read it every time. You can refuse to read it, but they have to give it to you. What you do with it after they hand it to you is your business, but I would advise that you do read it just to refresh your mind each time.
Biogen WILL send in a trainer to re-educate the infusion center and will tell them that they have been reported, but it won't happen if the disinterested patient sits willingly like a sheep and lets the infusion center slack off.
Please teach you daughter to stand up and be heard. It's HER body and HER health and HER choice, but she will do what she has learned from you. It appears that at this time, it's to complain on an anonymous board.
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