Cherie,

I read through your link and all I can say is that the issue is as clear as mud. My link to Biogen's charts clearly shows that they did not include the prior clinical trials in their safety numbers reported there. With your link it is impossible to tell if the numbers exposed to Tysabri include the prior clinical trials or not.

With it being as clear as mud, it is clearly up for interpretation. I still believe my interpretation is correct as evidenced by my example but this is clearly not enough to sway you. (At the end of the day I live with this risk, literally as I'm taking the drug) We don't have to agree. The only takeaway we both should have from this discussion is that posting PML risk numbers is fraught with potential for error/misinterpretation. Is this fair for someone contemplating using this drug? The label says 1 in 1000 with new wording that the rate in monotherapy appears to be less than this. Let's let the regulators decide what the PML risk is in monotherapy based on the correct patient exposure data in monotherapy.

Chris

My experience with statistics is that they are usually biased. People use statistics that flatter themselves. We saw this all through the last presidential campaign. Each side used what stats best fit their agenda.

It is truly as Mark Twain said, "There are 3 kinds of lies; lies, damn lies and statistics."

What it boils down to is what each person with MS feels comfortable with. I could never be like Cherie, never having MRIs, not taking any DMD. I would find it difficult to look at my husband/children/grandchildren and say I didn't use what was available for me, so now you get to take care of me.

I fully realize that I may end up not being able to care for myself someday anyway, regardless of the treatments I'm using now. But at least, and I mean least, I can say I gave it my best shot with what information/medicine I had available to me at the time.

This is evident with me being on Tysabri, when really, I'm probably a very, very mild case of MS. I figure I want to stay that way. It helps that I have double insurance coverage, make good money, and so that is not an issue. I believe I prepared earlier in life to get to this stage, not knowing then that I'd be in this situation now.

If life hands me PML, so be it. I'm fully prepared to meet whatever challenges lie in front of me. I have faith in Tysabri. Sometimes that is better than statistics!!!

With all due respect, this may be Cherie's decision, but the 2 of us live in Canada. MRIs here are a bit 'different' than in the USA. They are not done frequently in a lot of cases. Heck, I'll be lucky to have another one myself. The waiting lists to have this particular test done are quite extensive.

I've heard the same in other countries as well. Medicine is not the same everywhere. :)

Do you also supplement elsewhere beyond DMD's or Tysabri (as examples) for your disease? If so, what have you found that has worked for you? I'm much like you, I want to ensure that I'm doing the best I can for my disease course in my mind. I'd be interested to hear what other changes you've made. :)

I understand what you are saying about the MRIs. If I was in a different financial situation, I'd probably be more conservative. I was just stating that it would be difficult for me to be that way. Cherie seems to be at peace with her disease management, and I think that is great!! We all have to do what works for us.

I just know my personality, and know I could not be that way.

As far as other meds/treatment and such, I take a multi-vitamin and 2000 of Vitamin D-3 daily, and my bp med that I've been on longer than my MS dx. I walk a couple of miles 4 mornings a week with my neighbors, in better weather up a hill! I still need to lose about 50 lbs., so that is a battle I have always suffered with.

I don't drink alcohol or smoke. I take 1/2 a provigil occasionally when I know I have meetings late in the day. I drink a lot of Dt. Dew to help with fatigue. I go off it occasionally, but I always find myself back with the bad habit.

I go to bed early if my body dictates that I need the rest. I've learned to not let things stress me out, and my religion helps with inner peace and a sense of my belonging in the world, and my mission in life.

I give service to others as much as possible. For example, today I spent an hour at a local nursing home playing the piano. Then later this afternoon I took a meal to an older couple where the wife just had surgery and was in poor shape. I still had time to take a small 15 minute nap, and play games with my son and DIL after having Chinese take-out for dinner to celebrate the new year.

Focusing on others needs is a great way to minimize any discomforts you may be feeling personally.

I laugh and I love. I've given up the need to always be right. This is probably way more than what you asked for. Brevity never has been a strong suit of mine! :eek:

See, we're all so very different.

I gave up soda entirely a year and a half ago. I had some recently only when I was very ill with a throat virus (ginger ale is great when sick!).

For me, bigger than my DMD is my diet. I went low Saturated and Trans fats and cut out red meat entirely. I am so much more aware of what I eat now, where I wasn't before.

I'd stop my DMD before I stopped eating this way. It's almost the Swank diet, but there are some points of Swank I can't observe (I can't have fish/seafood etc due to allergy).

Quitting smoking was a big piece of the puzzle for me as well :) And exercising daily. Positivity, definitely!

I didn't give up smoking. I've never smoked or drank alcohol, part of my religion. We don't drink coffee either, so the Dt. Dew is kind of bad because I do look at it as a cold form of coffee. It would be better if I gave it up entirely.

It is a vice, and one that I'm working on getting completely out of my life.

Now the whole diet thing is something else entirely. I've had struggles with weight my entire life! Low fat, low carb, who knows what really works. I think we'd all benefit by adding more grain and fruit/vegetables, limiting our meat intake, and exercising more.

I'm also one who has yearly physicals for other things, and visits the dentist every 6 months.

I think the biggest help to my health I've given myself is lessening my stress. I quit worrying about what others think/do, and just be the best person I can be. I don't have to be in charge, and I'm willing to let others fail without jumping in to save them. If it is my responsibility, then I'm there! But I don't need other's problems in my life. That includes my children and their families. I'll do whatever I can to help - if they only ask!

I've definitely added more grain, fruits and veggies, and certainly limited my meat intake. Daily exercise. I've never driven a car, so I walk everywhere within distance to do so.

I too have struggled with weight my entire life. I finally found a way of eating that I like that is beneficial in more ways than one. It's easy to cut down on your fats. Eliminating red meat for me wasn't a big deal. I can still have my chicken and turkey!

I've lost a lot of weight and body fat eating this way since July of this year, and exercising. I don't find that I stray from the diet all that often (sometimes you have to allow a little treat to sneak in, but I'm pretty strict with what I eat).

I find I have a lot more energy and confidence at the end of the day. Like you said, eliminating the stress... and managing the diet and feeling good about myself is a part of that, and that also helps being positive :).

Hi Chris,

Since you think you understand your tables better . . . let's work with them then:

I have pulled out the numbers that are relevant for the purposes of this discussion (pg 14):http://library.corporate-ir.net/libr...s%20Slides.pdf

http://i12.photobucket.com/albums/a2.../Twotables.jpg

Do you see where Table 1 and Table 2 have differing cumulative/total patient numbers; Feb (7,500 vs. 18,000), May (12,000 vs. 21,000), Sept (17,000 vs. 26,200) and Dec (21,100 vs. 30,900)?

What would YOU propose the difference in numbers between these two tables (for the same months) represent?

The difference is that the first table shows the number of patients who were on Tysabri as @ Dec/07 (including clinical trials going at that time).

The second table shows the number of patients who’ve ever been exposed to Tysabri as @ Dec/07 (including ALL clinical trials, since the beginning of time).

Do you notice that Table 2 (the one that shows the 30,900 vs. 21,900) is where the "6300 @ 12+ months" number appears?

The reason the 6300 appears in Table 2 is because the number relates to “ever been exposed”, not “on Tysabri”), just like the 30,900 number does (see Dec/07):

http://i12.photobucket.com/albums/a2.../tabletwo2.jpg

You said you didn’t buy that argument because in Table 2, “The safety information lists 0 (zero) patients at 1 year of therapy until Dec 2007” and “There were zero patients at one year of Therapy on the slide until the Dec 07 numbers. This couldn't possibly be true if the original clinical trials exposure were included in the numbers. They did start new trials at the same time as the recommercialization.”

Table 2 does NOT have ZERO’s (through to Dec/07), it has “dashes”. Note the titles directly above (those columns with dashes). The titles indicate the name of the various meetings that were attended (ANN, ENS, etc.) during those particular months.

What those dashes simply mean is that there was NO DATA SUPPLIED during that function/meeting, NOT that the number was zero.

*As far as the the number of “new” trial patients (since the reintroduction), it is written above Table 1 (the “on Tysabri” table), where it says: “Clinical Trials: ~700 patients on therapy in clinical trials.”

Once you understand the information from the tables you’ve supplied, I suspect the numbers supplied in my link won’t look nearly so muddy to you either. If you still don’t get it though, all I can do is hope that anyone else that cares enough about the real stats will take the time to figure it out for themselves.

Cherie

I agree with your comment about stats, 4bm. One plus one still equals two though, no matter how you swap the numbers around. ;)

Everyone has to do what they feel comfortable with for their own personal reasons. You are accountable only to your loved ones, and me to mine. Only time tells if they were good choices . . . and so far I've done well with mine.

Let's talk again in 15 yrs or so though . . . ;)

I've had this disease a LONG time, 4bm, and suspect that am much older then you. I've had a good life, and will have no regrets.

Chances are you will eventually learn to be at peace with this disease too.

Cherie

Let's just leave the stats to the regulators
 

Cherie,

This discussion is clearly not advancing anyone's understanding of the PML risk with Tysabri and risks a re-escalation of board tensions so let's just leave the risk calculations to the regulators. I will definitely respect the boards rules to avoid strained discussions. Given the number of patients at 18 months and two years of therapy, this should happen relatively soon and then we can decide who was correct and was incorrect in seeing through the mud.

-- Is not likely zero but a recognition that the numbers were not material given that the drug was relaunched in July 2006.

Chris