Please call Biogen & complain about Tysabri PML Reportin

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Please call Biogen & complain about Tysabri PML Reportin

Postby ewizabeth » Mon Oct 26, 2009 7:29 am

I get my 32nd infusion on Friday. Biogen isn't reporting the details of PML cases anymore. I need to know what the risk is for people my age, with similar health profiles, having similar number of infusions, etc... I don't want the name and addresses of the patients, but I want the general data.

I've spoken to Biogen about this twice in less than a week.

Call them at 1-800-456-2255 for patient support. Tell them you want the information made available about the current number of PML patients. You want to know the country, the age, number of infusions, previous drug therapy, etc...

I told the last person I spoke to that I wanted to make sure the call was being recorded and that she would report my concerns to upper management.

I told her that I belong to a world wide support group and I know a lot of people taking Tysabri and that we're concerned.

I also said that I realize the reporting of PML cases isn't helping the company financially, but that since we are the ones that can be affected by PML, we need to know the information.

I told the person I spoke to that I'd be calling my doctor.

But they don't have the spare time or resources to be giving me Biogen's secret data details. So that's why I started this thread. I'm not going to make my doctor's office do Biogen's work. We need to make Biogen do their own reporting.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby ewizabeth » Tue Oct 27, 2009 7:45 am

My letter to my senators (feel free to copy the text to email your senator at the congress.org website)



Biogen Idec produces a medication called Tysabri for the treatment of multiple sclerosis (MS). Tysabri is very expensive for patients and is administered via infusion. There are currently more than 46,000 MS patients taking Tysabri, myself included.



There's a known side effect called progressive multifocal leukoencephalopathy (PML) - a potentially deadly disease, that's listed on the medication packaging and also gives Tysabri a "Black Box" label category and requires consistent patient monitoring for symptoms of PML.



Biogen Idec was previously providing statistical details of new cases of PML so that patients could decide if the risks were worth the benefits of the drug. They recently discontinued their reporting policy and the statistics of PML are not available to the patients taking the risks and paying for the medication.



Last week an EU news agency reported ten new cases of PML and Biogen Idec has stated they will not provide any details on the age, country of origin or length of time taking Tysabri - all necessary details for existing patients to decide if they will continue with this highly effective but potentially dangerous drug.



I urge you to contact the FDA today and also James C. Mullen, CEO of Biogen Idec to insist the company provide the statistical data publicly so that patients taking the risks and paying for this expensive medication will be able to make an informed decision in managing their general health and disease therapy.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby ewizabeth » Tue Oct 27, 2009 2:14 pm

I got a call from the Senior Director of Patient Services of Biogen Idec this afternoon and I have his direct phone number for future reference. He assured me that the risk is still within the 1:1000 even for patients with a greater number of infusions. The current number of confirmed PML cases is 23.

I explained to him why I disagree with the change in their reporting policy and why I don't think it's acceptable for them to put this duty on the backs of the physicians.

I thanked him for calling but until they change this policy or make it easier for patients to get accurate data and reports, I'll keep working for this to change.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby Lyon » Tue Oct 27, 2009 3:13 pm

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Postby ewizabeth » Tue Oct 27, 2009 3:54 pm

I don't know Bob, unless they expect this treatment to have a certain predictable lifespan and they don't want to put more research dollars into it before it starts to decline.

I'm sure that when the oral meds come out and show a good efficacy, people currently taking Tysabri will go in that direction.

I'm going to speak to my MS neuro about taking a six month break from Tysabri when I see him this Friday.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby Lyon » Tue Oct 27, 2009 4:10 pm

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Postby ewizabeth » Tue Oct 27, 2009 5:28 pm

Someone at the Tysabri support center told me yesterday that they believe that the average for disease activity to resume is about six months. That's why I'm thinking six months for a break.

When I asked the person I spoke to about that today, he said he didn't know that for sure, but if somebody from the support center told me that then it is definitely true. 8O You know, I like this medicine but this company is starting to make me wonder.

I know the guy was sweating bullets during our conversation today.

I'm also writing comments on major news websites. They're going to have to change something or people will start to notice.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby edife » Thu Oct 29, 2009 3:22 pm

Youre not helping people that need Tysabri and know there's risk such as myself.
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Postby HarryZ » Thu Oct 29, 2009 4:19 pm

ewizabeth wrote:Someone at the Tysabri support center told me yesterday that they believe that the average for disease activity to resume is about six months. That's why I'm thinking six months for a break.


That's an interesting comment from Biogen, Wiz. I wonder how they came up with 6 months vs 8 months or even longer. I've not seen any studies involving this kind of situation.

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Postby HarryZ » Thu Oct 29, 2009 4:21 pm

edife wrote:Youre not helping people that need Tysabri and know there's risk such as myself.


On the contrary....I believe that Wiz is doing Tysabri patients a real service in attempting to get Biogen to provide proper and accurate information so the user or potential user has the information required to make an informed decision.

Keep up the good work, Wiz.

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Postby ewizabeth » Thu Oct 29, 2009 6:35 pm

HarryZ wrote:
ewizabeth wrote:Someone at the Tysabri support center told me yesterday that they believe that the average for disease activity to resume is about six months. That's why I'm thinking six months for a break.


That's an interesting comment from Biogen, Wiz. I wonder how they came up with 6 months vs 8 months or even longer. I've not seen any studies involving this kind of situation.

Harry


I'm guessing it's because of their observations in those who had to go off of it with the feedback from physicians, and/or maybe that's something they kept track of when trial patients had to discontinue for one reason or another.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby ewizabeth » Thu Oct 29, 2009 6:42 pm

edife wrote:Youre not helping people that need Tysabri and know there's risk such as myself.


You might not make that comment if you'd had 30 infusions and wondered each month if you're at a higher risk of PML, or if it were your child, or spouse? Think about it. Do we want to be sheep? Or make them accountable. I'm certainly not going to make Tysabri go away, but I just might help in some way to make them more accountable.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby ewizabeth » Fri Oct 30, 2009 10:34 am

We just got home and I chose not to get my infusion today. The neuro spoke to me for about an hour. I'm going to go back in three months and talk about whether I want to go back on Tysabri, or go on something else. I'll check back in later with more details. I have another appt this afternoon and won't be home until later on.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
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Postby cheerleader » Fri Oct 30, 2009 11:23 am

ewizabeth wrote:
HarryZ wrote:
ewizabeth wrote:Someone at the Tysabri support center told me yesterday that they believe that the average for disease activity to resume is about six months. That's why I'm thinking six months for a break.


That's an interesting comment from Biogen, Wiz. I wonder how they came up with 6 months vs 8 months or even longer. I've not seen any studies involving this kind of situation.

Harry


I'm guessing it's because of their observations in those who had to go off of it with the feedback from physicians, and/or maybe that's something they kept track of when trial patients had to discontinue for one reason or another.


Here's information on the study the docs are using to base these numbers on...it was done in Amsterdam
http://www.medpagetoday.com/Neurology/M ... rosis/6674

"In that study, where most patients received around six infusions, there was no evidence of rebound, but the six-month follow-up period may have been too short to study this phenomenon as biologic effects of natalizumab may be observed up to six months after withdrawal," Dr. Vellinga and colleagues wrote. "Furthermore, that study focused on a transient phenomenon of MRI disease activity (gadolinium enhancement), whereas we study the cumulative burden of disease (T2 lesions)."

and wiz, you know I think the damage of MS continues whether or not the immune system is ablated or not...iron deposition continues into brain tissue. That's the only true measure of MS disability we have. For further info:
http://www.ms-mri.com/
hang in there-
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Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby patientx » Fri Oct 30, 2009 6:12 pm

Way to go Ewizabeth. I wouldn't presume to tell you to continue with Tysabri or not. And it sounds like you are keeping in consult with your neuro, which is the right way to go. But you are holding Biogen's feet to the fire, which is really necessary, considering how they have bent acting.
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