MS Drug Approval?

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MS Drug Approval?

Postby RevLeonidas » Tue Dec 21, 2004 12:59 pm

I wish someone could explain to me why it is that the medical industry is so engrossed with treating ailments instead of doing things to make a patient healthier. The current approach that healthcare provides, when it’s at its very best, relies on fractured logic. Maybe it’s because desperate patients are willing to try anything that’s easy to rid themselves of disease. This leads to the other confusing logic I’ve encountered in the MS community. Why is it that patients are so willing to believe that experimental treatments like Beta Seron, Avonex, Copaxone, or Rebif are the “best-bet” to making a body well? On the large-scale side of modern medicine, we are starting to see the fractures in the medicine approval process. We’ve been hearing a lot about Vioxx, Celebrex, now Naproxen with potentially life-threatening effects; however, is the fractured logic of modern medicine at its worst when it comes to patients and healthcare providers of small-scale medical issues like Multiple Sclerosis (MS)?

Medicine relies on a “standardized” methodology to determine whether or not a treatment agent is effective. The most trusted, tried-and-trued, methodology is the double-blind placebo-controlled clinical trial. This is how I understand it:

These most-trusted trials, the very best, rely on simple cause-and-effect logic applied using, ideally, a large group of subjects with similar characteristics: from this group, there are a solid “blinded” baseline of those on the treatment, and a solid “blinded” baseline of those on placebo (not on the treatment); and, “blinded” providers/observers recording patients characteristics which fall within, or meet, success, or failure, criteria established when the trial is proposed.

A key element of a solid “baseline” consists of a randomized group of subjects with similar characteristics: the larger the group, the better. Since the initial supposition that Multiple Sclerosis is an immune-disorder which continually leaves those effected with the disease with increasing disability; that is, it is expected that a patient with MS will continually score higher on a disability scale; this is how a baseline is established. Put simply, without treatment, the supposition was/is that bodies inflicted with Multiple Sclerosis will trend upward on a disability scale. This is the baseline that Multiple Sclerosis treatments are tested against.

One would think that since modern medicine has clearly communicated that MS is an “unpredictable” disease that that would fit perfectly into the randomized criteria: but does it? When I’ve discussed with healthcare providers and other patients how my condition has improved, and how I’ve found others who claim the same, I’ve got responses like, “that can be expected of MS; MS is an unpredictable disease, some people don’t necessarily get worse:” what.!? So, doesn’t that mean that some of the folks in the randomized group wouldn’t be on the upward trending disability baseline? So, doesn’t this make it upward trending with unexpected downward fractures?

If this is the case, doesn’t that challenge all the clinical trials for the ABCR drugs? Or, am I missing something here?

Be Well,
Rev. Leonidas
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Postby OddDuck » Tue Dec 21, 2004 1:24 pm

Hi, Rev!

I just had to answer your post!

All I can say is welcome to the club! (i.e. the "club" being those very few of us who have trouble with the supposed "logic" of it all as proposed by the medical industry, pharma companies, etc.)

Amen! :wink:

Deb
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Postby RevLeonidas » Tue Dec 21, 2004 2:16 pm

Few of us? How can we, those in the club, contribute to make it right? Is there a patient advocasy organization with some clout that we can get involved with?
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Postby OddDuck » Tue Dec 21, 2004 2:54 pm

I wish there was, Rev. The problem is the word "clout". We're outnumbered and out-powered by the pharmas, politics, etc.

I do what I can through the labor movement (unions) in the U.S., but you can see just from this message board alone, how heaven forbid you should actually "question" too many things going on in the medical world (or any industry, for that matter), because you'll literally get beaten up for it! :?

I did see recently where some researchers are questioning how clinical trials are being run (and I think I saw where even the NMSS said something on their website about advocating clinical trial protocols to change.) Not to mention there is talk now about something called the MTI as being a better "marker" for measurement of MS progression and disability correlations than the MRI could ever think of being. So, maybe something new will come down the pike soon.

This may sound defeatist, but from what I can see, we'd just be a whisper in the wind right now. :(

Deb

EDIT: Yes, Rev....I was correct. Such as the NMSS is in some people's eyes, on this matter, they agree with us, Rev. See: http://www.nationalmssociety.org/Research-2004Dec9.asp

Let's wish them luck. Perhaps if we do support the NMSS, we might be able to support them with this aspect, at least. They "theoretically" have the most clout for MSers, I'd think.

SECOND EDIT: I, at the very least, liked the following statement in the NMSS's article:
...MRI protocols are nearly always incorporated into clinical trials of MS, but because there is only a limited correlation between imaged lesions and a person’s clinical picture, MRI has not yet been accepted by the FDA as a “surrogate” for a primary clinical measure of benefit.


Amen, again, Rev!

Although, I MIGHT question who at the FDA told the NMSS that they do not accept the MRI as the primary clinical measure of benefit. Since when? HAH!

Other than that, though, there is "indication" at least that the NMSS can see that "something" isn't quite measuring up with the way clinical trials are currently being run. That's better than nothing!
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Postby RevLeonidas » Tue Dec 21, 2004 3:51 pm

"....MRI protocols are nearly always incorporated into clinical trials of MS, but because there is only a limited correlation between imaged lesions and a person’s clinical picture, MRI has not yet been accepted by the FDA as a “surrogate” for a primary clinical measure of benefit."

I guess that this means that this quote right here needs to be widely disseminated within the MS community; it proves that results from those trials are invalid. I would think that if the efficacy of a drug was in question, especially one with potential harmful effects, it would be deemed unsafe.

Wouldn't it be?
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Postby HarryZ » Tue Dec 21, 2004 9:45 pm

Rev,

Just read your posts this evening and found them quite interesting..to say the least!

I wish there was a simple answer to some of your questions but when it comes to MS, NOTHING is simple. A friend of mine, who has been researching MS for a number of years, knows how to read actual clinical trials. Having read several of the CRAB trials this person can't believe some of the conclusions that were written about the efficacy of these drugs. You often see some of these trials praising the MRI results and lesion loads that the MRIs show but then you look at the situation of lesion load correlation to symptoms and disease progression and it makes you wonder just how relevant it really is. Add to this the interaction between the very wealthy pharmaceutical companies, the FDA and the NMSS, it's not hard to understand why some of us scratch our heads when it comes to the drugs that have been approved for MS so far.

If you have read any of the threads on Tysabri that have taken place on this forum you can easily see that there are two very different trains of thought and opinions when it comes to this drug's reported efficacy.

MS is indeed a very mysterious disease which continues to become embroiled in controversy even among the expert scientists who research it.

Harry
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