This Is MS Multiple Sclerosis Community: Knowledge & Support

Arron,



If you look at that information closely, Tysabri did not give a 42% reduction in disability to MS patients....it reduced the "risk" of disability by that percentage. Biogen didn't even publish EDSS scores which measure disability because they were not part of the primary endpoint in the trials.

Up until that time, I had never seen a MS drug trial that measured "risk of disability" and still not sure what that is supposed to mean. Perhaps someone here can explain that phrase and what it actually means.

Harry

We can pick over the bones of the Tysabri saga for years to come, but the important thing is whether of not it gives benefits to those who are to beginning their infusions within the next month or so.

I sincerely hope that the treatment is safe (and that the safety monitoring proves effective). I also hope that people like Ronnie and Gary who are prepared to take the risk see some real benefits.

By the end of the year there should hopefully be patients who have received four or five infusions. We will be interested in hearing their experiences, which in turn may help others decide whether or not to consider this treatment option.

It might be appropriate to take a break from dissecting the Tysabri trials data, which can be interpreted in many ways.

Some brave people are willing to give this drug a try - they will be aware of the risks.

I for one would like to wish them all the luck in the world.

Ian

Sharon



Thanks for your post.



The article is not from me but from Ken Kam / Marketocracy

Best regards

Better,

My goodness....I've been able to get a personal response from you besides the quoted press releases that you post here

The investment in ELN certainly answers the question as to why we see all of the press information that you give us!



My previous message about MS medications had more to do with the results of the CRABs after all these years. I can remember when they first started becoming available in the mid 90's and the MS docs and pharmas were very excited about them based on the trials.

Well, we all know now that the CRABs just never reached their expected level of benefit. I can remember when Tysabri was first being generally used in Jan/Feb 2005 and the comments many MS docs were saying about the CRABs now that Tysabri was available......minimum benefit, difficult to take, many side effects, etc. With Tysabri now an alternative option, they could get their patients off a CRAB and hopefully things would be much better. We all know what happened next.

I have no doubt that a number of patients who got to use Tysabri for a short period of time felt better. Those coming off a CRAB would probably feel better just stopping the use of the drug. But you can't really tell how a medication is doing until you are on it for at least a few months and things start to normalize a bit. I maintain that after MS patients have used Tysabri for 12 months we will start to see a far better picture of the effect of the drug.

I really do hope that Tysabri patients do far better than they have on the CRABs. The frustration that patients have had to endure with the introduction of Tysabri wasn't deserved. Now they can focus on trying to get some quality back in their lives. My wife has had MS for 35 years and I know first hand how this disease can strip you away...piece by piece.

Harry

Harry, you are right, I forgot the phrase "risk of disability"

Semantics aside, Tysabri is without a doubt a potent drug. Also don't neglect the improvements on Quality of Life scales. Whether it lives up to its promise is of course TBD, as you've pointed out, but I think most everyone is excited at this new option.

The following is from an article we wrote earlier.


Quality of Life:

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Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.

Of course I'm compelled to make a few comments.

Better--sorry about that, since the info was in a section "My Take", I thought it might be you offering info.

Ian, Ronnie, Amelia and all who are anxious to have an infusion--

Yes, I think people are aware of the risks (more or less) but are they aware of the benefits, and, what exactly are those? I'm an avid proponent of "informed consent" and abhor misleading information. I think the decision to start Tysabri should be one that weighs the risks and the potential benefits.

As ironic as it might sound, I actually think the "anecdotal" stories of people on Tysabri with seemingly excellent recoveries with one or two infusions is hopeful for people with MS. To me, these reports seemingly suggest that perhaps the "disability" one experiences is the result of the inflammation itself (edema, etc.) and, that inflammation , so far, in those individuals, while indeed severely disabling, did not result in permanent damage to neurons, axons, etc. If there had in fact been permanent damage, I don't think people would be reporting their recovery. To say it another way, these anecdotal reports suggest people indeed experienced significant disability for long periods of time, but did not experience permanent damage. I find that very hopeful for everyone with MS.

Arron and Harry--about that "42% reduction in the risk of disability progression in two years".

I understand that to say as well that almost 3/4ths of the people on placebo did not have any disability progression in two years. To be exact, 71% of the people on placebo did not have disability progression in two years; 83% of the people on Tysabri did not have disability progression.

Just to try and keep everyone up to speed, here's a link to the letter Biogen sent to the docs today.

I wish everyone who takes Tysabri the best of health and recovery and I am thankful that so far I'm not in a position to have to make a decision about this.

Take care all

Sharon

Sharon,



This is another good example of using "relative" numbers as opposed to "actual" numbers when it comes to publishing trial data.

Simply put, with 100 patients in the trial, 17 on Tysabri saw their MS progress while 29 on placebo experienced the same. Relatively, that's a risk of disability improvement by 42%....a nice figure to publish. But in actual numbers, only 12 more patients out of the 100 who took nothing saw disease progression.





That pretty much supports the info that the patients in this trial mostly had mild cases of MS and weren't likely to have a lot of disease progression. But like many of us have stated, we won't know the real effect on patients until the end of the year.



Not sure I like the amount of "unknowns" by Biogen in this letter when it comes to PML.

I also wish the best for those who decide to try this drug in an attempt to give themselves some better quality of life.

Harry

Like Ian said, at the end of the year, we'll have a better view of Tysabri. I don't think "hoping a drug does some good" makes you get up and walk. I really don't think researchers know much of anything about how any of MS drugs work. If they have not figured out the connection between disability and lesions completely, how do they know something works. I hope it does Gary well.