Re: Tim's friend's mildly retarded son

["E. ALLEN SMITH" <EALLENSMITH@ocelot.Rutgers.EDU>]

From:	IN%"asgaard@sos.sll.se"  "Asgaard" 15-MAR-1996 14:06:44.11

>The reason FDA has not approved this drug is most probably because
>it does not make mildly retarded boys less retarded. But of course,

	Actually, there is some evidence that nootropics do work. I've been
doing a literature review on the subject (soon to be a full meta-analytic
review if I can find the proper statistics for combining multiple results from
the same study), and there is some evidence for them working... slightly.
	The lack of FDA approval can be described as being due to a combination
of three factors:
	A. Most sucessful studies of such drugs have been on healthy
individuals. (For instance, vasopressin only appears to work on those whose
brains are reasonably intact in the portion that deals with memory; I find this
unsurprising). However, the FDA refuses to approve drugs for the purpose of
enhancement of normal humans. (They have the excuse that it's against their
charter). They even include the decline of IQ with aging in this category,
unless it's profound or associated with other problems.
	B. Most of the known to work nootropics, etcetera are beyond the
patent period. Thus, the well-researched ones tend not to be profitable for
a company to work on getting through the FDA. Instead, they're developing new
ones... often with a concentration (as with hydergine) on drugs to treat
senile dementia or other categories that the FDA _will_ approve.
	C. The FDA is notoriously conservative. I'm generally willing to trust
anything they pass as safe and (at least marginally) effective, but that's
because they're completely anal-retentive about the whole business. Anything
they're willing to pass without serious political pressure (of the types
mentioned in another post) is OK... it's just that they don't pass a lot of
stuff that is OK.
	This topic's relevance to Cypherpunks, aside from the confirmations
that you mentioned, is low... aside from that it's of interest to Extropians
such as myself and Tim May.
	-Allen