From: Technotranscendence (neptune@mars.superlink.net)
Date: Sat Nov 30 2002 - 08:18:38 MST
On Saturday, November 30, 2002 1:10 AM Ramez Naam mez@apexnano.com
wrote:
>> 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.
Naturally. I was more throwing it out to stoke debate -- perhaps a
stupid strategy on my part given that it's a holiday weekend.:)
We already have some of this in supplement studies. The Harvard vitamin
C study comes to mind -- though it was not a controlled study. Most
good human studies I've seen in this area are small scale -- very short
duration (less than year) and only a few dozen or a few hundred peopel
at best. This does not seem to be enough to convince the Crockers of
the world.:) However, I feel the current data are suggestive and also
meta-analysis tend to support the view that antioxidants & Co. how life
extension potential.
However, I'd stay away from FDA approval here since it costs too much
money (several $100 million) and takes a long time (7 years, last time I
checked). This rigs the system so that unpatentable chemicals don't get
tested as rigorously. This is why I mentioned the "proof that they
work" question and not the regulatory one.
Perhaps a question on the regulatory side -- aside from the obvious
solution of abolishing the FDA, exiling its members (and supporters) to,
say, North Korea, and spreading salt on their property:) -- is how to
get around the regulations? What about exporting drugs to less
regulated markets? (I'm sure this is already done, but I wonder how
much is being done in the field of life extension drugs.)
Happy Holidays!
Dan
http://uweb.superlink.net/neptune/
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