They have discontinued reporting individual PML cases on 8-Ks. Actually makes a great deal of sense since I know of no other drug in the entire drug universe where individual drug adverse events (that are listed in the label) are reported on 8-Ks much less in a weekly report on the company website.

So, if you go by the numbers Riverwild posted, you have 8 people getting PML out of almost 40,000 on the drug?

However you disect the numbers, that is still pretty rare.

My neuro was just telling me at my appt. yesterday that in his research that an acceptable number could be as high as 7 out of 1,000 risk and it would still be beneficial to be on the drug. I don't know that I agree with that, but he must be looking at it from a practicioner's point of view.

I guess if it meant life or death kind of a situation, I would agree. But MS is such an unusual disease with many different manifestations in different people.

I just have to look at my life, and what it is doing for me. I'm not worried about getting PML, and MS is not really affecting my life in any great way. If Ty keeps it that way, then great!

Having said that, I'll be having my first MRI after being on Ty for 10 months. I'll let you know how that turns out on Monday!

Unfortunately the press doesn't do their homework.

Around 48,000 patients have taken Tysabri at some point after it was brought back to market. Out of these patients, 5 have been confirmed to have PML. The 3 other cases were in the registration trials (non-montherapy) out of about 3000 patients in the trials.

No, the 40,000 number does not represent ALL the people who've ever been on Tysabri (i.e. including those from the trials) . . . BUT the 8 cases of PML does represent how many occurred (INCLUDING those from the trials). Apples and oranges, kinda.

In their Q4, 2008 report today, they are quoting the December announced numbers:

"At the end of the year and post-marketing setting, TYSABRI had over 10,000 patients with at least 18 months and 4,300 with at least two years of therapy."

http://seekingalpha.com/article/1190...nscript?page=1

So, the 8 people (including the trials) have gotten PML, and the total number of people that have used Tysabri for 18+ months, is:

10,700 - 18 mo (post-marketing)
4,300 - 24 mo (post-marketing)
1,800 - 18 mo (trials)
1,400 - 24 mo (trials)
18,200

This would amount to a current ratio of 8:18,200 or 1:2275 cases of PML.

(Now slightly higher than what I posted in January @ 1:2600 http://neurotalk.psychcentral.com/sh...Tysabri&page=2 . . . because it usually takes a few months for cases to be confirmed out of the previous quarter numbers).

Cherie

These 8-K filings were made for the following reason:

"Form 8-K is the “current report” companies must file with the SEC to announce major events that shareholders should know about."

In the case of announcing PML cases, it fell in the following category:

"Section 8 -- Other Events
Item 8.01 Other Events (The registrant can use this Item to report events that are not specifically called for by Form 8-K, that the registrant considers to be of importance to security holders.)"

The medical, patient and shareholder community value transparency, and very public reporting of this information . . . even if Biogen's "marketing efforts will continue to focus on the 'efficacy story', education on PML, and placing PML management in the context of the overall product."

http://seekingalpha.com/article/1190...nscript?page=1

Cherie

You can't mix the trial data with the commercial data as the commercial use has been changed from the trial use. Your denominators are old as they are as of Dec 31st. They aren't aavailable but they have increased. Plus there's a lot more going on with when in treatment/where the PML is occurring than than your bottom line BOLD PML risk number implies.

lady_express_44 and komokazi

seems to me this is heading into another ping pong match between the two of you

I am not sure that it is helpful to the other members to have this back and forth

you both seem to interpret the same data differently and so perhaps just agree to disagree and let the other members interpret for themselves without this added confusion

please stick to the guidelines I outlined before for you on this.

post relevant info to the boards only and take your disagreements on the info to PM please

thanks

My concerns with the Tysabri were that my neurologist would only contact me after I had called in with concerns about learning of newer pml cases.... It's such a tough call on what to do. I always hear it from the media first,

I just wanted to say a quick hello. I just joined the boards. Since I'm on Tysabri, every few months I do a quick search to see if there have been any new PML cases, and today when I did the search, it brought me here. While the latest case announced last week isn't going to push me to stop taking Tysabri, I would like to be prepared and determine for myself what level of risk I am willing to take. I've been on Tysabri for 14 of the past 17 months. My doc put me on a 3 month holiday after 12 months.

So has anyone come up with your own statistical breaking point? How are you factoring in the potential increased risk for PML over time? Based on that pdf file link someone posted, it looks like there are 5 post-marketing cases and 20,000 who have been on it over 12 months. 1 in 4,000 is still a super low risk in my mind, but at what number does the FDA pull the drug? Is it 1 in 1,000?

Life is normal for me on Tysabri and I'd sure like to keep it that way.

My neuro stated (and he does seminars for Tysabri) that their acceptable risk is 7:1000, so I don't think the company would start pulling patients off the drug unless there was a huge outbreak of PML.

Personally, as long as I feel good, I'll stay on it until something better/easier comes along. Mostly the better part! That is how I handled the interferons. I just want to stay the way I am today, and I feel Ty is the best med out there now for that prognosis IMHO!