11th case of PML -- patient in U.S.
 

I didn't see any announcements of this on the forum in earlier listings.

This was published a few days ago. The article says that for those on Tysabri for 12 and 18 months the risk of PML is still WELL below one in 1,000. One analyst from Deutsche Bank claims the rate is actually approaching one in 1,000 for those on Tysabri for more than 24 months. 43,000 people are now on the drug.

http://online.wsj.com/article/BT-CO-...24-714686.html

Another article reads "The PML incidence remains below the long-projected risk of one in 1,000 patients developing the infection. After the previous case, a Jefferies & Co. research note last month put the revised PML incidence at one in 2,490 after 12- month Tysabri therapy; one in 1,400 after 18-month therapy; and one in 680 after 24-month therapy."

http://www.nasdaq.com/aspx/company-n...tysabri-update

one more thing...

This is worrisome. We will have to dig even harder for knowledge about PML cases.

"Biogen said on its earnings conference call earlier this month that it would in future communicate new cases by word of mouth to physicians and patient advocacy groups."

http://uk.biz.yahoo.com/24072009/323...tion-case.html

BUT....I will still stay on my Tysabri for now because it has been a miracle drug for me.

I didn't bother posting about it, since it is the last announcement we are going to get anyway, and it just seems to stir up bad feelings for too many people here.

Cherie

"by word of mouth"? What a sorry situation. It makes me wonder what they are hiding. Its less than forthcoming on their part.

Anyone ever heard of the saying that a little knowledge is a dangerous thing?

The release of the limited data on the PML cases provides for wonderful speculation from non-scientifically trained financial analysts and armchair statisticians but provides little insight into what the risk factors for developing PML are. Limited snapshots of the case data have suggested wildly different things. The first reported cases were clustered between 12 and 18 months. Since that time, we've seen no new cases in that treatment period even though the patients exposed in that timeframe has grown significantly. Now with a clustering of cases over 24 months of treatment, everyone's rushing to the conclusion that its treatment duration related. That could turn out to be a factor but it could just as easily be something else.

All we really know for certain based on what's in the public domain is that Tysabri treatment can lead to PML, PML can be clinically diagnosed early, and identified interventions can lead to better PML outcomes.

Komokazi, are you employed at Biogen....Just kidding..:D

No, not an employee of Biogen or Elan. Just trying to put some perspective into the tea leaves that everyone is trying to read. I'd like some info on the risk factors for PML as I'm at 32 months of Tysabri therapy but there's not much you can read into the top level case information other than possibly something that is different in Europe (genetics, other drugs they use, your ideas?)

I didn't post it or comment on the last case reported because I was away.

Biogen said in their AGM that they would be providing updates in their quarterly reports. As I understand it, further information will be available to neurologists and rheumatologists. They just have to request it.

If your doctor doesn't have updated facts on PML cases, or hasn't discussed the facts with you at your regular appointments, you need to let them know that you want all the information at hand when you see them. I have an excellent neuro, but I've had to help him to help me a few times ;).

I see him every three months and he makes sure if I call in between, that he gets the answers to my questions. He keeps up on the available known information on treatment of PML cases. He and I both made sure that the radiologist was aware and up to speed on PML imaging.

Information will be out there. We just have to keep looking and make educated guesses with what we have available, and remember that our guesses are just that, since correct information will eventually be available after it is studied and dissected by the bigheads.

Like every other drug out there, this one went through the studies required by the FDA. In addition, it was studied more than any other drug when it was withdrawn. It is the second drug EVER to be returned to market after withdrawal. It continues to be scrutinized more than any other drug on the market. Between scientists, doctors, patients, investors, statisticians, analysts both financial and scientifically oriented, and the drug companies themselves, along with the internet, there's very little hidden about what's happening with this drug.

The best part of the whole giant blob of Tysabri, it's history and information is that for me, it works. I am sticking with it. :)

Being a person with a financial background, I have a cynical view as to why they are no longer going to post new cases on their site. It's because every time they have, their stock has tanked.

I called Active Source this morning. In answer to my question in the near future they will have info as to how many have been on Ty for 3 yrs. As of June '09 10,000 have been on it for at least 24mths-as far as I remember there are 8 pml cases-most in Europe-this is still below 1/1000. As Riverwild posted we will be able to updated by our Drs as to pml cases.

I have had 36 infusions and am very thankful for Tysabri:D

Linda