Multiple Sclerosis (MS) Support Group

Previously 13 cases were confirmed before biogen stopped announcing confirmed case in July of this year.

It took 3 years to get to 13, it took took 3 months to get 10 more confirmed cases. Still mostly in Europe.

1.42 in 1,000 converts to 1 in 704

Did you notice where this article was printed in? The company stated last year that they were not going to be putting those numbers on their web site any longer.

Only the stock holders get that kind of information.

I took it for a year. The results were wonderful but I worried when is it going to be my turn. So I stopped. Currently on nothing.

KK

Kind of makes you a little more secure in your decision to have stopped it? I'm watching closely the news, IN THE STOCK MARKET, as you note. I'm a little disappointed in the US-FDA, that the European Union has been better at monitoring this..I think the impending label change was forced on the US-FDA by the EU.

I've been attempting to get the PML incidents in the FDA Adverse Event Reporting Database System(AERS). The FDA has been very sticky about giving out this information. I felt it is "open disclosure" in the US, so it should be easily available...but it is open disclosure in the US profit driven-stock market economy. :(

Iyt can't be denied ythat most opf the PML has been in Europe. So the European Union should be looking most critically at these incidents. The US FDA is just coming along for the ride.

That is most of the reported cases in the US. When I made my final decision to stop was when people were going to the ER for it & the patient had to tell the doc what was wrong with her. Doc knew nothing about it.

"I'm a little disappointed in the US-FDA, that the European Union has been better at monitoring this..I think the impending label change was forced on the US-FDA by the EU."

You are a little disappointed in the US-FDA, when most of the PML cases linked to Tysabri have occurred in the European Union??? Ummmm, okay-but that really makes no sense at all..., if anything, you should be disappointed in the EMEA for allowing so many PML cases to develop in the first place. And none of this current information released has anything to do with changing the FDA approved label of Tysabri as the companies were already discussing label amendments with the FDA

Also, when the number of "23" confirmed cases of PML is being discuss, it is unclear from the EMEA announcement whether or not the 3 original trial patients from 2005 are included in this number...,so it can actually be "20" NEW confirmed cases of PML since its reintroduction in 2006, and not 23.

Both Elan and Biogen point out that the incidence of PML remains below the one-in-1,000 risk cited on the drug’s label. They also point to its efficacy in slowing and possibly even halting the progression of multiple sclerosis.

Further, the EMEA announcement said their review would “discuss any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment”, so this has nothing to do with the FDA labeling requirements here. In my opinion (for what it's worth) the EMEA will more than likely look to implementing more restrictive requirements that our Touch program requires, since it's working so well in the US.

Lastly, further details on the new cases were unclear, it was unclear how long the affected patients had been on Tysabri, what prior treatments these patients had previously received (such as azathioprine, methotrexate, Mitox/Novantrone, etc.), where they were actually located, and so on.

With over 46,000 patients currently on Tysabri therapy, again, incidence of PML remains below the one-in-1,000 risk cited on the drug’s label.

Some of the above are actual facts based on releases by the companies & some of the above is based on my own humble personal opinion.

I'm getting ready for my 40th Tysabri infusion on Wednesday, woo hoo. Take care everyone..., Lauren :)

The reason the OVERALL Rate is still below 1 in 1,00 is because befire 12 infusion it is 0%. But when that is separated out it is closet to 1 in 750 as was reported in as notice by the FDA on 9/2009.

This repetitive claiming that the rate is still at the 1 in 1,000 when it was introduced is just like that commercial...with a child who gets a bike, as a present, but is only allowed to ride it in a small square. What does the commercial say "even a child understand the details in the small print are not fair" Its a commercial for credit cards & the small print that surprise people when they use there credit card....

Here is the FDA notice advising that there does appear to be a link to increasing Ty duration and PML.

http://www.fda.gov/Drugs/DrugSafet...

The FDA notice says 1.3 in 1,000 which converts to 1 in 770 not the 1 in 704 that this article states. Wow is that a big load of my mind...geez I don't even know why I was concerned about it?

Such foolish things to be concerned about!

This repetitive claiming the rate is still below 1 in 1,000 is very much like a pyramid scheme that was used by Bernie Madoff in the stock market, but it crumbled when the economy went bad.

...if more and more people could be convinced to start Ty so there are a lot of people in the first 12 months, the risk will remain below 1 in 1,000. But it will crumble if more people are at over 24 infusions.

All that is requested is honesty in Ty use. Now it is smoke and mirrors as your reply illustrated, so obviously.

European regulators reported 23 cases of so-called progressive multifocal leukoencephalopathy (PML), more than twice the 11 cases Biogen reported in July.

In September, the U.S. Food and Drug Administration said 13 cases of PML had been reported in Tysabri patients.

http://boston.bizjournals.com/bost...