Here is an article suggesting that the monitoring of Tysabri in Europe (and in particular Germany) is lax and this might be one risk factor for higher numbers of PML. Interesting.....

http://industry.bnet.com/pharma/1000...opean-doctors/

The person I spoke to today said that the risk of PML is more with an increase in infusions, but that even those people fall within the 1:1000. Those patients with less infusions have less risk. Sorry I didn't make that clear.

He also said that they do not recommend taking a break from Tysabri. When I asked him about the comment someone from the help center said to me yesterday, that disease activity seems to resume after about six months from stopping Tysabri, he admitted he didn't know that for sure, but that if somebody told me that from his support center, it's definitely true.

I'll be asking my MS neuro about taking a break when I see him Friday.

Just to clarify:
 

The person I spoke to today said that the risk of PML is more with an increase in infusions, but that even those people fall within the 1:1000. Those patients with less infusions have less risk. Sorry I didn't make that clear.

He also said that they do not recommend taking a break from Tysabri. When I asked him about the comment someone from the help center said to me yesterday, that disease activity seems to resume after about six months from stopping Tysabri, he admitted he didn't know that for sure, but that if somebody told me that from his support center, it's definitely true.

I'll be asking my MS neuro about taking a break when I see him Friday.

Please dont make them stop prescibing Tysabri cause i'm progressing in the worst way past 9 months on Copaxone, Rebif, back to Copaxone, supps ect.
I'm history in 12 months at most if Ty doesn't slow it down.

Nobody wants them to stop precribing Tysabri. We just want to know what the risks are. They were providing the details of the PML cases to the patients but they don't do that anymore. If they're keeping side effects from us, especially deadly side effects, we can't decide if it's safe for us to take it.

Many of us have been on Tysabri for a long time and we need to know the statistics of those who get PML so if we find ourselves in a high risk group, we can either take a break or switch to a different therapy.

I want Tysabri as an option, but they need to be honest with the patients if they want us to relax on this subject. I hope you can take it and get good results. We want it to be safe though, and that includes for you and anyone else about to start taking it. :hug:

Edife,

I absolutely agree with Wiz, we do not want the choice to take Tysabri removed again. we just want the drug company to give us information so we can make informed decisions.

If you start Tysabri today, you will be in a group of 45,000+- patients who are taking Tysabri with a risk of 1:1000 of PML.

Wiz and I and some of the others here belong to a much smaller subset within that 45K number. We are in a group of 7500+- who have been on the drug for more than 30 months within that group of 45K. The longer a person is on Tysabri, the higher they say your risk is now, according to the information being alluded to everywhere except where it should be stated truthfully, immediately and accurately, to the patients who may be affected by the information that leads to understanding that rate of risk

That is what we are fighting for, information, so when you get to where we are right now, you will HAVE the information you need to assess your risk and comfort level and not have to go through what we are going through right now.

I know a few people who were in the original trials and have had 75+ infusions and they are not happy either. Imagine how they feel knowing their subset, which is less than 2500, can't make an informed risk assessment because the drug company won't tell them what they need to know either.

We are not trying to limit choice. We are trying to make sure that we make good choices for ourselves, and we cannot do that without information.

Well said, Wiz and RW.

Honesty from this company, so that people can make fully INFORMED personal desions, is all I've EVER cared about when it comes to this drug.

Cherie

Hi Cherie,

What you and others are saying makes a lot of common sense but common sense and how big pharma operates unfortunately don't match up!

In the pharmaceutical world, most companies are in a very competitive battle to get a share of the revenue dollar. A small shift in market share can translate into millions and millions of dollars of revenue gain or loss. If Biogen continued to post information like they did about PML cases, it would only hurt their revenue generation and Tysabri's rough road for them is anything but what they had hoped would be a blockbuster medication.

I'm guessing that Biogen knew very well that the number of PML cases would start to rise quickly as time went on and that likely had a large influence in their decision to stop posting information on their site. It's all about the money with Biogen and little if anything to do with what is best for MS patients in helping them make an informed decision.

I have followed Biogen's handling of Tysabri from the beginning and this has left a VERY sour taste with me. Their tactics have pretty much been the same from the start....and it has been very little to do with MS patients and all about revenue generation.

Harry

They have to operate like a business Harry, and that includes battling for the revenues. But I agree that they're handing this very poorly. Most of the pharma companies have had questionable practices from time to time it seems. I think this one stands out so much for us because it affects MS patients and it's a deadly side effect. :(

I think this one will reflect in the revenue department if they don't change something so the patients who take the risks and pay the money for Tysabri can get the information they need to make informed decisions.

Ironically, if Biogen keeps withholding information to protect their share of the market and keep the investors happy they could be shooting themselves in the foot. Patients may not have a lot of power but they have some. If patients decide to go off Tysabri or refuse to begin it because of the lack of transparency then it could still wind up hurting Biogen and the investors. I think they made a poor call when it comes to disseminating information--they hoped us "passive" patients would just keep taking the drug if they stayed quiet. I think they also hoped the PML cases wouldn't be high enough to ultimately cause concern. But I think the line has been crossed. Bad policy and planning on their part. (not to mentione ethically questionable)