Hi again Chris,

*edited*

- we have previously had this conversation about stats & efficacy *edited*, and there are some people here who can become very upset by the re-hashing of this subject

- you don’t need to worry about ME being biased towards any treatment option, as I have had MS for 18+ years and have never even been on any DMD. Either way, it’s not a competition, at least from a patient perspective.

However, since you are missing some of the information you need to make an informed argument, I will provide a very quick synopsis on the numbers . . .

The risk profile of 1:1000 is based on all of the people in the original Tysabri trials, not just those in the MS trials. This included the Crohn’s patients, and it was determined that the risk for PML was 3:3000 (or 1:1000) for those on a mean of 17.9 (18) months.

No matter what other drugs the patients were (or had been) on in the trials, the best go-forward projection Biogen could predict (for PML potential”, while on monotherapy), was 1:1000, over 18+ months. You, and everyone else who’ve been on it, accepted that risk ratio.

Regardless of how you (or I) calculate the current ratio of cases, the stat is lower then was predicted. How could anything that I say (which is still less than Biogen’s prediction of 1:1000) be “scaring” anyone?!?

Virtually all PwMS are all immune compromised, and/or have used prior immuno-modulatory/suppressant drugs. Some suggested that the cases in the trials might have only occurred because of the immunosuppressant qualities of Avonex and Tysabri combined . . . but we now know that people even on monotherapy, i.e. only ONE drug at a time, might be too immune compromised to safely start on Tysabri.

The prescribing criteria for Tysabri states that it is “... recommended for those who have not been helped enough by, or can not tolerate another treatment for MS ...”. That basically ensures that most of us have PREVIOUSLY been on “some” drug that has affected our immune system . . . and would “justify” every case of PML to date. Well all, except one... the European patient who had used NO treatments previously.

The bottom line is that we now know that PML is just going to happen occasionally with Tysabri anyway . . .

TOUCH is in place in the US, to screen out “the most” at risk patients ~ those patients who have used/are using meds that might increase their odds of getting PML. If TOUCH protected people from PML, the Florida patient wouldn’t have gotten it.

Our neuro’s don’t want us to die any more than the makers of Tysabri do. They are making their best judgment call, in the US and in every country that Tysabri is available . . . so your point about “where” people lived when they got the PML is irrelevant. Careful selection and intricate monitoring of patients helps, but it will obviously not stop PML from occurring.

As for the current stat, we can’t count all 35,500 people who’ve been on Tysabri, some who’ve been on for as few as ONE or TWO infusions. While my calculation for a ratio wouldn't be 100% correct, it is as close as we can get and definitely much more accurate then “only four cases of the 35-odd thousand that are on it . . .”.

The 9500 number confirmed in Dec/08 (those who’ve experienced T for 18+ months) includes those 3000 patients who used Tysabri during the trials. Since it seems to take 1 – 3 months to confirm PML, I really don’t think it is necessary to “speculate” how many more (or less) people might be on Tysabri since the last confirmed count.

Nor do we know how many are currently being investigated for PML since the 9500 was confirmed.

If you prefer to take out three patients that got PML in the trials, you will also have to reduce the number from 9500 (- 3000, that were in the trials) to 6500. That would still result in a current “experience” ratio, as best as we can calculate it, of 4:6500 (or 1:1625). . . . which is not THAT far off 1:1357.

There were hundreds of drop-outs in the trials, as there are some % in any trial. Generally those people dropped out because they got too sick (or otherwise didn’t respond well to the treatment during the trials). They are NOT COUNTED in the final statistical analysis for efficacy, so the stats we hear about are based on those who thrived (reasonably well) throughout the duration.

I already spoke to the efficacy comparison between our various drug options, and attached a few links to make my point. And, while it is nice not to have relapses, I (personally) am not going to risk my life to try to avoid them . . . even with the odds as LOW as they currently are.

If you are more comfortable quoting whatever numbers you feel ok with, that is entirely up to you. I will stick (and answer) to the numbers I believe are correct. If reality (from someone else’s perspective, that apparently you don’t agree with anyway) “scares” you . . . perhaps you shouldn’t be have taken the risk associated to this med . . .?

I wish you (and everyone else) well, Chris. I really do hope the odds for getting PML from Tysabri ultimately pan out to be MUCH lower then anticipated, and that Tysabri proves to be a relatively safe (liver function, cancer risk, etc....) and effective treatment option for this disease in the long-run.

Good luck,

Cherie