MS Drug Approval?
Posted: Tue Dec 21, 2004 11:59 am
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
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