Thank you for posting this BBS.

Matt, you and I have talked about the way these statistics are presented, and that IMHO, they are inflated.

The article that I referenced at one time during our discussion was on an LDN forum . . . so perhaps the thought was that this may be biased. This was the article:

Is This the Drug for Me?
By Art Mellor

This article is the third in a series that discusses things to consider when evaluating trial results for a new treatment. In this instalment, I'd like to cover a set of questions to help you be more informed when reviewing the results of a treatment trial.

There's no formula for deciding whether a particular study was done "right" or not. You need to look at the results, ask yourself (and your neurologist) a lot of questions, and assess the answers in the context of your own situation. Below, I'll cover a good starting set of things to be concerned about for any treatment trial results.

Start with the inclusion criteria used for the study. What sort of people did they recruit? Are they similar enough to you? If you have progressive MS and the study only includes relapsing-remitting, it may not apply to you at all.

How many people were in the trial? How many completed it? Why is that number different if not everyone finished? When looking at other reported results, notice how many people were included in reporting that result.

How long did the study last? Is that long enough to assess benefit in MS? Were the benefits seen in the study maintained after the time period of the study?

Look at the criteria they measured to determine efficacy of the treatment. Is that something that is important to you? Is it entirely meaningful? Perhaps they measure the number of relapses, but not the severity? Since the number of lesions in your brain can't currently be correlated to disability, does it matter if they increase or decrease?

Watch out for how results are reported. You need to notice whether they are relative or absolute. If 20% of the placebo arm had relapses, and only 10% of the active drug arm did, then there was a 50% reduction in relapses compared to placebo (that's relative), but only a 10% reduction overall (absolute). Guess which one gets advertised?

Generally, benefits get reported as relative measures, because that usually amplifies the number and makes it look better, without being incorrect. Side effects are usually reported as absolute numbers. If 1% of the participants on placebo had their leg fall off, and 4% of those on active drug did, you wouldn't see it listed as a 400% increase in fallen off legs.

Ask yourself if the listed benefits are worth the risks of taking the drug. These risks include the side effects, impact on life-style, and financial burden.

If a drug changes your annual relapse rate from .82 to .67, an 18% reduction, your first impression might be excitement. But fractional relapses, which often result from averaging or annualizing, can be deceiving.
Let's turn these decimal numbers into fractions with a common denominator: .82 is about 12 relapses every 15 years, and .67 is 10 relapses every 15 years. Are you willing to stick yourself with a needle daily or weekly, suffer the site reactions and side effects, all to have 2 fewer relapses over the next 15 years? While I'm being a little dramatic, this is how you decode the numbers used in marketing to have meaning to you.

I urge you to get the prescribing information for the drugs you take (see last month's article for how) and read through the clinical trials section and practice asking questions as you read the results. Chances are you'll have a very different view of the drug than you did before, and not necessarily a worse one.

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Art Mellor was diagnosed with MS in 2000 and co-founded the Accelerated Cure Project for MS in 2001, a non-profit organization dedicated to curing MS by determining its causes. You can learn more at www.acceleratedcure.org or contact Art at art@acceleratedcure.org

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The approx. 30% reduction in relapses rates (which is a secondary measure of the trials anyway - and does not necessarily correlate with disease progression), are RELATIVE to placebo. In absolute terms, there was ONLY 10%. Since it's 'averages', a small % of people may have seen a huge reduction, and the others saw nothing. That's the bad part about stats . . .

The exact numbers are available though, if anyone wants to look at them on the FDA site. Even then, the "relative" vs. "absolute" concept must be taken into account with these numbers.

Cherie