Can someone please explain why Biogen is now stating that the risk of PML is still 1:1000 from 24 to 36 months if only 13,000 people have taken the drug more than 24 months? I got the 13,000 number from an article dated Oct. 23. Haven't 18 of the PML cases been 24 months and over? Thanks!!!!

You can use statistics to prove/disprove almost anything you want. It all depends on what data you use to obtain your numbers.

People think that if 1000 people take Tysabri and 1 gets PML, then that means the risk is 1:1000. When it comes to statistics, this may not be true at all because one has to work with probability and several factors have to be taken into account to obtain the real risk factor.

Now it may very well be the risk is 1:1000 but the chances are slim that it is because of the many factors that would have to be considered here. But I would guess that Biogen is going to use the number that makes Tysabri as attractive a MS drug as possible.

Harry

Natalie,

Part of the problem lies in the fact that the PML case number is as of a relatively current date (Late Oct) and the 13,000 patient number is as of Sep 30th. More patients crossed the 24 month threshold in that time.

The other part of the problem is how ratios are calculated statistically with this small sample size. Because of this small sample size, there is potentially a large amount of variability in what the real answer will ultimately be. These calculation methods are universally accepted, hence the FDA's concurrence that the PML risk is similar to that seen during clinical trials.

Update today from Biogen of the JCV Assay
 

http://www.wsw.com/webcast/lz6/biib/index.html

Of course to the financial community. Biogen was asked in the Q&A portion about the timeline for the assay - reply was months to quarters, big hurdle was to work with the KOLs (key opinion leaders) on how to utilize them (presumeably more of an issue for the 50% who would test positive as having the JV Virus dormant in their systems).

Chris

http://www.independent.ie/business/w...t-1946602.html

MS wonder drug 'balanced alert'


Wednesday November 18 2009
PHARMACEUTICALS
Elan and partner Biogen Idec aim to find a "balanced way" of alerting investors about the number of brain infections linked to their Tysabri multiple sclerosis drug by the end of this year after a surge in cases, CEO Kelly Martin said yesterday. It was recently confirmed that Tysabri has been linked to four deaths and 24 cases of the deadly brain infection known as PML since the product was reintroduced in 2006.




Anyone see anything missing in this statement?

WTF!!! What about the PATIENTS???:mad:

Letters streaming forth to both...GRRRRR.

Before you get too exercised about this, remember he is talking to a financial news source and the financial news source's only concern through this whole PML process has been the number of cases and the reaction it causes to the stock price. Who knows all of what was said and clearly the financial news source may have selected what they felt was important.

I understand that it was a financial news report. Regardless of who the statement was directed at, the patient should never be left out of any statement when it comes to side effects and problems with a drug. They should always come first. Elan and Biogen would do well to remember that, and to emphasize it in every statement they make, and I for one will remind them at every opportunity.

I do not ever forget that if it wasn't for us, they wouldn't have a drug on the market, nor would they be making what amounts to over a billion dollars a year at this point in sales of this drug. I do not ever forget that while they may have to spoonfeed investors, the very people who are taking the drug are the most at risk and what those patients are risking means a whole hell of a lot more than money, and both Elan and Biogen should remember that too, as should every other drug company out there that markets a drug and makes money from it.

Go RW!!!!!! You are so right about the patients. I love how the article states they are hoping to find a "balanced way" of letting investors know about the PML risks. Ha ha ha. That is shorthand for "leaking as little information as possible."

In the meantime, there have been 3 more PML cases added to the German blog for November. :( All it states is that the info came from an "internal Biogen paper." If this is true that would now make 27 post-marketing cases.

http://chefarztfrau.de/?page_id=716

RW, do you know anything about this?

Three more cases of PML in Germany? Did anyone else get this information? :(

http://www.xconomy.com/boston/2009/1...ngle_page=true

Tysabri, the MS Drug Haunted by Deadly Side Effect, Doesn’t Look So Deadly Anymore


Good discussion of efforts in work on the JC Virus/PML front

Up to date info on PML cases/deaths/patients exposed