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Some MS patients experience “natural” improvements in disability



Multiple sclerosis (MS) patients sometimes experience “natural” improvements in disability at least over the short term, according to a new study led by researchers at the University of British Columbia and Vancouver Coastal Health Research Institute.

The study, published this month in the Multiple Sclerosis Journal, is the first to quantify improvements in disability in patients who are not taking immunomodulatory drugs such as beta interferon drugs or glatiramer acetate.

“Many people assume that MS patients experience only disease progression and an increasing disability,” says Helen Tremlett, the study’s lead author, an associate professor in the UBC Faculty of Medicine. “While we did observe that no change or a worsening in disability was most common, up to 30 per cent of patients did experience an improvement, and this was often sustained over one to two years.”

While there were some patient characteristics more associated with a greater chance of improvement – including being female, younger, and having the relapse-remitting form of the disease – a wide spectrum of patients experienced episodes of improvement.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1693

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Hmmm....30% of the study group improved their condition even though they were not taking any drugs. Had they all been on a DMD, it would have been stated that the particular DMD gave them the improvement. The general consensus of the efficacy of the DMDs states that there is about a 30% benefit. Makes you wonder!

Harry

I don't think it's the same 30% they're talking about. In this study, they appear to be saying that 30% of the patients experienced an improvement of their EDSS. However, without reading the full paper, we don't know the magnitude of that improvement. All we know is that it was scored as a reduction of 0.5, greater than or equal to 1.0 or greater than or equal to 2.0 points. In constrast, the 30% that's often referred to regarding the DMDs is a relative reduction in relapse frequency above the placebo group. In this 30%, they're talking about the magnitude of the response to the DMD, not the number of people who are helped. The 30% benefit above placebo is seen across all patients on the DMD.

NHE

Yes, the detail of the study is lacking but in general, it said that 30% of the group who did not take any DMD, experienced a "natural improvement" of their disease.

Let's say that these 30% just happened to be enrolled in a DMD trial and that they were taking the drug. They didn't have a relapse so they would be part of the 30% who benefitted over the placebo group. Statistically, it would be massaging the numbers to the extreme but it's something that can be done to obtain the result that you want. Remember that Copaxone followed a similar route when it initially got rejected by the FDA as not reaching statiscal significance in its trials. More trials, number massaging and voila, it just reached the numbers it needed for approval. And we know what the Cochran Group wrote about Copaxone's effectiveness on MS....or should I have said none effectiveness.

My main point is that due to the very nature of MS, trial results obtained may not be giving us a totally true picture of how any one drug really affects MS. But if you review the sales literature of the DMDs, you get a very different picture.

Harry

Wouldn't 30% of the placebo group also experience some natural improvement in their EDSS?


NHE

I think I get what you're getting at, but that's why the bigger the trial the higher the confidence. The bigger the trial, the more likely the "lucky" people are evenly distributed between the placebo and DMD arm's of the trial.

Yes they would but the percentage could vary. And certainly not all of the 30% group involved in the trial which found no disease progression would be enrolled at the same time in a drug trial. I was simply theorizing the possibilities to show how variable these results can be and how one could manipulate stats to show what they want to show. And the efficacy of the DMDs over the years has been quite variable and limited and not anywhere near what the docs initially thought it would be.

Harry

That's what I used to think but a person involved in drug trials told me the numbers are usually determined by what the expected result is going to be. The FDA likes numbers for public confidence but it doesn't matter how many people are involved, the results are going to be the same (minor variances) regardless of the numbers. Put 100 people in a trial and the efficacy will end up at x%. Put 3000 people in the same trial and the x number will end up being very similar.

Seems strange but by the time a Phase III trial begins, the people involved have a pretty good idea of what the result may be. The cost of these trials is huge and they want a postivie result and won't conduct them unless there is a pretty good chance of success. Don't blame them. What can happen, though, is that nasty side effects can enter the picture unexpectedly and that can ruin a trial.

This is what I was told and I'm certainly no expert in the field. And add MS's complete unpredictable course and you really may not end up any further ahead than when you started.

Harry

By the actual statistical confidence interval will drop (ie below 95%) as you reduce numbers. I would also guess (as I am no expert) that the FDA would have a minimum number or statically calculated minimum confidence interval decided / agreed before the trial is approved.

But, I am not disagreeing with you, as I also believe that they can play with the maths to make the case they want, appear better than it really is, as compared to others.

I don't know or have heard what confidence level the FDA demands in data submitted to them. You read about trials that have perhaps 300 people in it and others with 3000. And I wonder when a disease like MS is involved, does the confidence interval mean a lot when you see the data on the original DMD trials compared to what the general population ended up experiencing. The docs were led to believe these drugs were going to be just great when in fact they were anything but!



Yes, that was my main point and we saw that very situation happen with Copaxone when it finally got approved by the FDA. Statistics are a very manipulative animal and can be used to make whatever point you want. When that is applied to medications used for MS, I guess one has to be very cautious as to who is presenting the information....and what side of the business fence one may sit.

Harry