From: Ramez Naam (mez@apexnano.com)
Date: Fri Nov 29 2002 - 23:10:52 MST
From: Technotranscendence [mailto:neptune@mars.superlink.net]
> On Friday, November 29, 2002 10:45 PM Robert J. Bradbury
> bradbury@aeiveos.com wrote:
> > Very extended lifespan is within the realm of knowledge
> > and technologies that I think we will have in this decade.
> > Whether one will have proof that they work and FDA
> > approval (in the U.S.) for them is a much more open
> > question.
>
> I'm interested in the "proof that they work" question. How
> can this be done without, say, getting a large scale study
> that takes a human life time to complete?
One mechanism that would work for FDA approval would be to show
"decreased mortality" for a certain cohort over a certain period of
time for a certain disease.
For example, you could get your drug approved as a treatment for
cardiovascular disease if you showed that 70 year olds who took your
drug for a year were 50% less likely to die of a heart attack over the
next 5 years than 70 year olds who did not take your drug. (Indeed,
50% would be an absolutely huge effect.)
Now, this hypothetical drug might be acting on fundamental ageing
processes, not just heart disease. And this hypothetical drug might
have already been shown to extend life by 30% or 40% in rodents. And
preliminary studies on primates might already be showing that the
primates getting this drug were ageing more slowly. All of that is
fine. Once your drug is approved for therapeutic use for heart
disease or whatever else, it's on the market, doctors can prescribe it
off label, and a grey market for the compound will start to form.
mez
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