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The following note was written by Art Mellor of The Boston Cure Project. It is something that each and every MS patient should read before deciding what drug he/she may use.

Harry

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Is This the Drug for Me?
By Art Mellor
Dec, 2005

This article is the third in a series that discusses things to consider when evaluating trial results for a new treatment. In this installment, 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.

--

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

Great post, very interesting, we all must press for all the factors so we can make an informed decision.

HarryZ wrote: 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?

And to answer this question.... YES!!!

Relapses are scary as hell, dont know if I will recover, dont know what lasting damage there will be if I do recover. To me if I had no relapses I wouldnt have MS. So every bit of reduction is excellent news to me. I choose copaxone based on the fact it has very low side effect, decent efficacy and a mechanism of action that doesnt suppress my immune system.

Good post. HarryZ. I think the most important point is regarding people with progressive MS. If you don't have relapses, new T2 lesions, or Gd enhancing lesions or a long period of time, it is doubtful the any of the pivotal trials for any of the disease modifying treatments are applicable to you. I feel as though not using drugs for non-relapsing MS gives drug companies more motivation to come up with new treatments for progressive MS as there is an unfilled niche.

Kronk-you would seriously take copaxone every day for 15 years just to prevent two relapses with no clear benefit in long term disability?

I wouldn't.

Obviously I based my decision on more than just the reported 30% reduction in relapses, which as noted in the post by HarryZ above is likely a stretch. I based my decision on what is shown by Copaxone studies by the manufacturer and independents. Namely the longer you are on it the more effective it becomes as shown in the link below, I have heard after 10 years of treatment reduction in relapses can be as high as 80%. Also my decision was helped by the mechanism of action which unlike other MS therapies does not suppress your natural immune system, it modulates it. One hypothesis is that it “educates” white blood cells to not attack myelin by containing the four amino acids that are found in myelin basic protein. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of EAE.

The other important piece is that for me it is side effect free. I do get the bee sting feeling which lasts about 5mins and varies in intensity, and occasionally I will get a small lump and some site tenderness for a couple days. Overall a minor annoyance done every night at 10pm. I pinch and “rough up” the area of injection, tuck the needle under my armpit for a couple minutes to bring up its temperature, then stick it, and it’s all working well.

It really is a personal choice that I made based on all the information I could find. I don’t regret or have any doubts about my decision as I educated myself prior which I think is key to any decision we make in life.

http://www.medicalnewstoday.com/releases/180599.php

This study is important for the MS community as it further confirms the benefits of continuous long-term use of Copaxone® and its ability to effectively slow the natural progression of this disease”

http://www.ncbi.nlm.nih.gov/pubmed/17920545
http://www.neurology.org/content/56/6/702.short

Studies on mechanism of action

Do you really believe the drug companies are going post a negative study. The drug company set up the study and they can make it say what they want. The drug companies job is to sell their drug and they are not going to post anything that is unfavorable. The best way to evaluate a drug is to see what actual people who have used the drug. There is no reason for them to lie. Go to a site like "Ask A Patient" and see what the people who take the drug have to say. If you look at Copaxone and look on page 3 you will find a person who has destroyed his liver. He took the drug for 8 years and now he is on the liver transplant list. This doesn't count the dead people who do not have a chance to tell us their story. With these real people telling you what the drugs have done to them and you still want the drugs. There was a study done in England showing people doing the MS drugs did worse than those who didn't do the drugs. What is wrong with that study?

http://www.naturalnews.com/037028_Big_P ... tions.html

http://www.askapatient.com/viewrating.a ... PerPage=60

want2bike wrote:Do you really believe the drug companies are going post a negative study. The drug company set up the study and they can make it say what they want. The drug companies job is to sell their drug and they are not going to post anything that is unfavorable. The best way to evaluate a drug is to see what actual people who have used the drug. There is no reason for them to lie. Go to a site like "Ask A Patient" and see what the people who take the drug have to say. If you look at Copaxone and look on page 3 you will find a person who has destroyed his liver. He took the drug for 8 years and now he is on the liver transplant list. This doesn't count the dead people who do not have a chance to tell us their story. With these real people telling you what the drugs have done to them and you still want the drugs. There was a study done in England showing people doing the MS drugs did worse than those who didn't do the drugs. What is wrong with that study?

It's kind of doubtful that the copaxone is responsible for that patient's liver transplant given that copaxone is just polypeptides which normally do not enter the blood stream and the clinical trials revealed no changes in liver function tests compared to placebo.

I assure you that if the drug companies had control over the pivotal trial results, they would have made the data look much more impressive. Copaxone failed to meet the disability progression endpoint in both pivotal trials (and also in the recent tecfidera trial with an unblinded copaxone arm)

-C

Wanna do you buy your tinfoil hats in bulk?

You have added nothing to this discussion... once again as a person without MS you are just spreading your fear mongering propaganda. The choice to take Copaxone was mine, not yours, so your statements are not appreciated. Many people have been on Copaxone for nearly 20 years with no ill effects. Nearly every study has some sort of a bias, you have to sort through and find the information that has importance to your individual situation. I doubt you have ever actually read a full study you skim through with your negative filter looking for whatever will support your ridiculous conspiracy theories.

You have stated that you take 6 apricot seeds daily, which have arsenic and cyanide, please do us all a favor and take 12 or 18 instead...

Kronk wrote:Wanna do you buy your tinfoil hats in bulk?

Kronk wrote:You have added nothing to this discussion... once again as a person without MS you are just spreading your fear mongering propaganda. The choice to take Copaxone was mine, not yours, so your statements are not appreciated. Many people have been on Copaxone for nearly 20 years with no ill effects.

Many folks on Copaxone have experienced lipoatrophy. There has been some discussion that this might be linked to an apoptotic process perhaps due to its clastogenic activity.

http://www.copaxone.com/Resources/pdfs/ ... mation.pdf

Glatiramer acetate was clastogenic in two separate in vitro chromosomal aberration assays in cultured human lymphocytes

NHE wrote:Many folks on Copaxone have experienced lipoatrophy.

Quite right NHE, no drug is side effect free. Like I said, you must read the literature and decide what information pertains to your individual situation. For example lipotrophy can happen with any subcutaneous injectable whether it be a vaccine, or vitamin booster. It is rare, and MUCH rarer in men. Add to that the fact for my situation I am a gym rat, lift heavy between 3 and 4 days a week and maintain a body fat of between 9% and 11%. Any dent from lipotrophy would probably just look like more definition in my abs It does make it more challenging to find injection locations though...

NHE wrote: Glatiramer acetate was clastogenic in two separate in vitro chromosomal aberration assays in cultured human lymphocytes

I don't put a lot of faith in "in vitro" (in test tube) studies as it is a controlled petri dish that does not take into account the billions of other variables that are "in vivo" (in body).
I really don't want to defend Copaxone or my right to choose to take it. I like the intent of this article as it encourages us to make an educated decision with all the facts that apply to our individual situations. In my situation Copaxone makes sense.

Kronk wrote:Add to that the fact for my situation I am a gym rat, lift heavy between 3 and 4 days a week and maintain a body fat of between 9% and 11%. Any dent from lipotrophy would probably just look like more definition in my abs It does make it more challenging to find injection locations though.

I wonder if you could inject it in strategic locations to enhance you abs over time