TMI, Redundant, TMI!!! Sheesh!!

June of 2007, I was asked to participate on an FDA panel as an MS Patient Advocate to evaluate the RiskMAP for the TOUCH protocol for Tysabri. Some of you may remember the extensive questionnaire (anonymous) I sent out for your to fill out.

I was the first speaker of the first day of the 2-day conference. I had 15 minutes to present this information. I spent almost 2 weeks putting it all together in a power point presentation.

Biogen was the first speaker on the 2nd day of the Conference. It was obvious to all that their presentation was redone as their speaker did not match their slide presentation and my name was mentioned more than once.

My point being that the FDA is monitoring Biogen and Tysabri. After that conference and since then, the labeling and monitoring process has changed. Biogen had hoped to have the black box warning label removed. It will never happen. Biogen and the FDA are well aware of the risks involved with Tysabri. No drug is 100% safe, I don't care who you are or what the drug companies say...there is no such thing as a 100% safe medication. Period.

As to the publication or notification to the patients of the risks involved of Tysabri -- It's called informed consent. I am not saying that Biogen is doing everything they are supposed to be doing, but there are MANDATORY, not ADVISORY, requirements that must take place before the patients have their first infusion of Tysabri.

Please take a look at the track record of other drugs on the market. Sometimes adverse events/side effects aren't known until the drug has been on the market for well over 10 years, sometimes longer. This drug has only been on the market since 2004.

It was the first new drug on the market to treat MS in almost a decade. It was clearly stated at the first hearing in 2005 that there WOULD BE, not MAY BE, PML cases reported. I was there, I heard it. The FDA heard it...any one who listened to the transcripts of the hearing heard it. None of us are stupid, as RW stated.

PML is going to happen. It was predicted by Biogen. It was predicted by the FDA panel when they approved the drug to be returned back on the market. That was the reason for the TOUCH protocol. That was the reason for the PML Tracking system. That was the reason for the evaluation of the TOUCH protocol every year.

Now, let's look on the positive side. How many people has this drug helped to have a better quality of life? How many people have other drugs helped have a better quality of life that have a much higher death rate? Aspirin is always a good example, tylenol is another one. Do they pull those OTC drugs from the market, no. They don't even lower the stock market price of the makers of these drugs...not even a blip on the radar. Does it make the headlines...NO WAY.

I am not trying to lessen the degree of this lady's death in any way shape or form. It's sad. Very sad. But this one ups man's ship stuff has got to stop. The reporters are the ones who are letting this get out of hand - again - and some of you are taking the bait. Let's let the experts, like say her doctor, report what her REAL cause of death was, before jumping to conclusions and picking fights.

There are a lot of people on this forum (and others) who are benefitting from the drug and don't need all this negativism right now. Reporting facts is one thing, but continuing to belittle one's opinion who is actually taking the drug is unbecoming and serves no purpose.

Let's stick to the facts and stop speculating.

Why is it that every time someone gets PML and/or dies from it after taking Tysabri, there are others in this forum who feel the need to imply "I told you so!" This is very insensitive and not helpful to people taking Tysabri. What new information do we learn each time? Not much. But we get the same old tired debate where those on Tysabri are made to feel like dummies being duped by Biogen. Life with MS is already hard enough. And it's the Christmas season so let's be supportive of one another and thoughtful about what we say.

I continue to find it difficult to understand why some people equate other's comments about being very cautious with Tysabri as "negative"!


If Biogen is so aware of the dangers of Tysabri, then why have they pushed its introduction into the marketplace so fast from the very beginning? They have run into hurdle after hurdle with this drug as more problems surface as each month passes. It's safety has been questioned from the outset and although all drugs have a risk level associated with them, Biogen's method of operation seems to push ahead as fast as they can and worry about the problems afterwards when they show up.

I and others for months have pointed out the concern we have for this drug as it gets used by more and more patients. It isn't being "negative" but simply giving another point of view.

Harry

*This is the place to ask questions, get information, talk to people who are on Tysabri, and help each other out.*

The information about PML has been posted as it was reported, as has this death. When more information becomes available, it will be posted.

Please keep this thread to the spirit and reason for which it was started.

Harry I do believe you are missing my point. I am not going to debate it here. This is not the place. And I am not going to continue this useless commentary any longer. Sorry...it serves no purpose whatsoever.

Merry Christmas.

The cause of death for this patient is only speculation.

The cause of death could have been PML. While the Tysabri was removed from the system, the immune response may have been delayed/affected by prior methotrexate treatment. I don't know how long this drug may affect immune response.

The cause of death could have been IRIS. Inflamation from the immune response could have worsened the syptoms and resulted in death. Maybe the PLEX should be less aggressive.

The cause of death could have been complications due to the patients rheumatological condition.

The cause of death could have been due to some other hospital or outside acquired infection.

From Biogen's 8-k

" Patient had also received prior therapy with methotrexate for a rheumatological condition. "

ditto.

this is not a thread for the nay-sayers of tysabri to post on.

this thread was made for those who are on tysabri or thinking about it to get information and support. from those who have first hand knowledge. people who have been on it or are on it.

the article and information about the person who had died was first posted in a responsable manner. others popping in with the "i told you so's" type of posts do not belong here. when all of the facts are reported (autopsy results i imagine) they will be posted. until then, yep, it's all just speculation.

natalie expressed it well.

Finally, some good news in this MS journey! I had an MRI after my 6th infusion of Tysabri. No enhanced lesions, no new lesions--everything looks just the same as it did before I started the drug. Whoohoo!! Now I am off to California to celebrate the holidays, my birthday, and no new lesions!!!

That's great news, Natalie! Congratulations.....and enjoy your holiday!

Oh, almost forgot.....Happy Birthday!