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.