I've been going over the data, such as it is, and one thing I notice right away is that the weight loss, both rate of loss and total weight loss in the recent trial and the 2004 trial (at least for the 1mg dose)are virtually identical. This was heralded as a huge success in 2004, but in 2006 it doesn't support commercial outcomes. What?
The difference in the conclusion is not based on the differences in performance of the dosed groups, it based on the difference in performance of the control groups. This makes the conclusion extremely suspect.
In the recent trial they put these folks on a tight diet and exercise programme with doctor visits, feedback, prompting, the whole deal. It's no wonder the placebo group lost weight. Who wouldn't on a programme like that?
Moreover, it should be no surprise that the treated group lost the same weight. Why should they lose more? They were all on the very same diet and exercise programme. Natually their weight loss will be nearly the same. This substance does not impede food absorbtion, it sdoes not suppress appetite, and it does not induce weight loss in folks who are on a diet there in essence, they are told to eat more than they need.
There is an equation between energy in, energy out, and weight gain and loss, and AOD9604 won't upset that equation one whit. Metabolic was wasting their time and our money with this latest trial. It was bound from the start to provide this very result and no other.
What AOD9604 does is make it easier to access the fat stores to make dieting easier and produce better results. Diet needs to be self-driven to loweer levels as fat is accessed. This phenomenon has to be self-driven to become manifest. In thais sense, the 2004 trial was actually better designed.
I can't say I really know how to trial this drug, but I have a few ideas. First, it seems to me that you would want to stick as close as possible to the animal studies that showed great efficacy.
The animals were for the most part free feeding. You would want to allow the human participants to free eat and free exercise in the same way. Let them become as encouraged or as discouraged with their progress as they may.
Maybe you would start them out for maybe 4 weeks on a common programme, but then you would want to turn them loose, tell them to go for as much weight loss as they could manage. The Doctor would just monitor progress and make sure that the participants didn't bring any adverse health issues onto themselves.
I believe that such a trial would have demonstrated very good results, much as one would expect looking at the 2004 results, and extrapolating them for another 12 weeks. Had the 2004 trials been run for 24 weeks, there is every liklihood that statistical significance would have been achieved on at least one dosage group and maybe on all of them.
I can't imagine that Frank Ng is very pleased with these results. There must be some dissention within the company as to how these trials were run. I have been critical of the way the first trials were run, but in hindsight, I think that in actuality they were more realistic that the recent trials.
I have reluctantly concluded that this outcome is an unmitigated disaster, not only because of the losses the shareholders have suffered and the damage done to the reputaion of the company and the biotech sector in general, but moreso to the millions of people who could otherwise have expected to have access to a very safe, effective medication of great assistance as an adjunct to real-world diet and exercise programmes.
I can only wonder if there is any possibility at all of a reconsideration. I know that there are some who would think I am delusional, but I realize that this cause is lost. It is really a shame, though, because the bottom line is that AOD9604 actually does work to inhibit lipogenisis and facilitate lipolysis as all previous experiments have demonstrated so conclusively.
I've been going over the data, such as it is, and one thing I...
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