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Posted by Alan F. Bachrach, M.D. on 15:54:08 2004/02/22
In Reply to: Re: Dr. Vinik's Discussion on Diabetes Station posted by Martin
Let me give you an analogy. There are currently 3 drugs for Alzheimer's disease on the market. A fourth is either here or imminently on the way. These drugs were approved based on the fact that when given to Alzheimer's patients, the patients scored a few points better on some psychological screening tests for Alzheimers than did control subjects. If I remember correctly, for Aricept, the Mini-Mental State Exam difference was 1 point on a 30 point scale. Exelon was a little better, but made people nauseous. Since the number of patients in the study was so large, the 1 point difference was statistically significant but clinically meaningless. Of course, there might be a few patients who dramatically improved while everyone else deteriorated and thus the AVERAGE was 1 point better. If so, I have never seen one of these patients. (and I'll bet they were patients who were misdiagnosed anyway) The drugs are marketed to "slow down" the rate of decline in Alzheimer's patients. If you have to make a choice between the expensive medicine and the cruise, in this case, take the cruise.
So the answer is, it isn't black and white. I am not interested in a drug which provides a small but statistically significant reduction in daily insulin requirements. But, that might get the FDA to approve the drug. And I suspect that if the drug "worked" (in the dramatic sense that you and I want it to work)it would already be obvious. I have two kids, ages 9 and 11, who have had IDDM since 2 1/2 and 3 1/2 respectively. I'm desperate too. I'm just somewhat jaded by what I have seen in the pharmeceutical industry.
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