What clump of pml cases and where did you find this info ?
Linda

I haven't weighed in on the statement from the CHMP/EMEA yet because I have been away and then had to work a bunch of OT, but I have a LOT of information that I will post tomorrow morning when I have time!
(and as usual, I have a LOT to say...)

OK, sorry to be late! Work's been busy lately!

The EMEA/CHMP issued a statement the other day that states that they are reviewing the risk/benefit ratio for Tysabri. http://www.eurobiotechnews.eu/servic...ash=58204a138f

The EU has no TOUCH program in place, and it is believed that they are reviewing the R/B ratio in advance of setting up a TOUCH-like program due to the number of PML cases. They stated the reported number of cases as 23.

As you will see when you click the link, the reporting news agency says the FDA has confirmed that there have been 23 cases of PML since 2006. Since BIIB/Elan both said in their quarterly conference calls last week that there were 15? cases, obviously what the FDA confirms makes it look like 8? more cases popped up in the space of a week? I'm sticking question marks in there because neither Biogen nor Elan confirmed that number yet, nor are they expected to, since they continuously state that they will not release the number of cases of PML anymore.

This is unacceptable to me as a Tysabri consumer. I've already let Biogen know that when they called me this week to tout their new patient support program. I am asking you to do what I and many others are doing. Please don't just blow them off if and when they call you about this support program. Please speak with the person who picks up the phone when they redirect your call.

Ask them if there is any way to ENSURE that your conversation is being taped. Tell them you want to be heard. Let them know how you are doing on Tysabri and then tell them you aren't happy about them keeping patients in the dark about the PML patients. Let them know you understand about privacy but that we are not asking them to give us names. Tell them you want the country, the age, the sex, the previous treatment history and what drugs they were on, how long they were on them, how long after prior treatment did they start on Tysabri and how long they have been on Tysabri. Tell them you want a call back from a superior in the company with some answers.

Tell them how you are unable to comfortably assess the risk when you have no information. Tell them it's too long to wait for your next scheduled visit with your neuro. Tell them you are very uncomfortable with continuing to use Tysabri because of the lack of information. Just keep talking until they get someone else to call you back. Let them know we are talking, comparing notes and moving toward action as a group worldwide. Tell them how you believe that having to search investment news is the wrong way to get information. Tell them you are NOT a mushroom and you don't like being kept in the dark and being fed ****. Remind them that they are making a LOT of money off US and that we as patients deserve to be kept up to date more than anyone else does, since we are the people who are at risk!!

Try to do all this while maintaining a polite tone. It may be hard to do but give it a shot. Just be firm and continue to state that you want someone to call you. Take the name of the person you speak to and ask them to be assigned as your caseworker so that you can follow up if you do not get a call back from someone.

We as a group can have an effect here. We deserve more information and we can make sure that we get it sooner rather than later. When Tysabri was withdrawn from market back in 2005, it was the patients who made a difference and we can do it again if we all work together.

On a more sorrowful note, the first man who was diagnosed with PML after Tysabri's return to market has died. His wife posted to a German MS site that is keeping track of PML cases along with people here in the US. I am not going to copy and paste it here since it is long and needs translating which makes it longer still. It's just sad and my sympathies go out to her and the rest of his family.

As usual, I'll post whatever I hear and hope you all will do the same. I hope everyone's doing well!

I just got off the phone with a Biogen support rep and told them about my concerns. I told her that I'm thinking of stopping taking Tysabri since the reports about PML aren't being made public anymore. She got nervous and started to read from a report stating the the company's new policy about regarding the reporting (or lack of) new PML cases.

I told her I was calling my doctor to ask him more about this. That really isn't fair that they should have to handle this though. My doctor's office isn't making any money off of doing the infusions. They don't charge much for the infusions and it costs them more than they make from all that's involved. Why should they have to do Biogen's dirty work?

RW. Great ideas. I'm getting ready to call Biogen now. Which patient died? There were 2 announced at the same time. Was it the treatment naive man who was on Ty. for 17 months or the 56 year old guythat was much worse off?

Found the post over the weekend. Called Active Source this morning. Didn't like the person I spoke to- Tanya - Asked to have my case manager call me.
I had #39 last Fri. Thank G-d doing well

Wow. Biogen entry level phone staffers seem clueless. She said she wasn't aware of the increase in PML cases and started to rattle off the 1:1000 risk info. She just kept apologizing. Her name was Kristen.

I will give her credit for passing me on. I'm on hold right now to speak to a "higher up" person.

Ohhh, she came back and claimed that no one else knows any more information than she does. I think it was a fake play. No one wants to deal with this at Biogen. How frustrating. She told me to call my doctor.

By the way I was told all calls are recorded but I think it is good to ask. At least all my complaints are on record if they even bother to review them or pay attention.

Call back and ask for a supervisor. Tell them to make sure your concerns are reported to management. Try to get a number in corporate to call.

Yes, I asked that my concerns be reported to management. The "higher up" was the supervisor who she said didn't know anything more.

I went to the Biogen Idec website and clicked on management, then found the "contact us" phone numbers. I called and asked for one of the management team and spoke to their assistant. Somebody is supposed to call me back.

Sending you a PM for that email address Natalie.