From: lady@uhunix.uhcc.Hawaii.Edu (Lee Lady)
Subject: FDA/ Amino Acids/ Smart Drugs
Followup-To: sci.med
Summary: An interview with Richard Wurtman
Keywords:  amino acids   FDA   alternative approaches
Organization: University of Hawaii (Mathematics Dept)
Date: Fri, 4 Sep 1992 07:16:29 GMT

The September issue of NUTRITION ACTION, published by the Center for
Science in the Public Interest, has a telephone interview (conducted in
July) with Richard Wurtman of the Clinical Research Center at MIT.  It
should be of interest to everyone involved in the undying sci.med
argument about the FDA, smart drugs, nutritional supplements,
alternative [as yet] treatments, etc.  I think there's plenty of
ammunition in the interview for partisans on both sides of this
argument, although naturally each side will quote selectively.

It's worth noting that Nutrition Action precedes the interview with a
disclaimer.  "Wurtman's findings are preliminary....  You may or may not
agree.  Either way, his results are fascinating."  

Basically, Wurtman's comments don't support the extreme positions
expressed in sci.med by partisans on either side.  On the one
hand, Wurtman's comments on the probable value of megadoses of some
amino acids (in particular tyrosine and tryptophan) lend little
support to anyone claiming that those who recommending or purveying
such megadoses are quacks, charlatans, and frauds.

On the other hand, I was disappointed to see that he does support FDA
regulation for amino acids.  When asked whether this will occur,
he says "I devoutly hope so.  The amino acids are accidents waiting to
happen.  It's likely that some of them will turn out to be useful in
treating some disorders.  But if they're not regulated as drugs, we'll
never know."   (Readers can decide for themselves whether or not this
last sentence makes any sense to them.)

He does believe that there are safety concerns involved.  "In pure form,
a nutrient is metabolically different than if it's eaten as part of
food....  You can't use their safety as a food constituent to say that
they are safe as a drug."  He goes on to cite specific concerns, mostly
having to do with the possibility that tryptophan (for instance) might
be taken in combination with other drugs which would accentuate its
action.  Readers can make up their own minds as to whether these
dangers are really great enough to justify keeping tryptophan off the
market.

It's important to remember that that's what it comes down to -- keeping
it off the market.  As the game is set up now, the only choices are to
either have tryptophan available in an unregulated fashion as it used to
be, essentially as an OTC drug, or to have it not available at all.  As
Wurtman agrees, there's no way that anyone can make enough money from
typtophan to justify some comany going to the enormous expense of
getting FDA approval.

And the way the the FDA approval game is set up is that the process
begins with a company wanting to make money by selling a drug.  The
company then has to convince the FDA that it's in the public interest for
that drug to be available.  But if there's insufficient monetary
incentive, the issue of public interest never arises.  Unlike the
drug companies, the public has no champion before the FDA.  

(These last two paragraphs are my views -- for what they're worth.
Wurtman doesn't address this issue.  But I think it's clear from the
information he gives that if amino acids are regulated, then tryptophan
will not be available in the USA for the foreseeable future, even
though Germany and Canada have approved it as a prescription drug.)

Wurtman does indicate that tryptophan is a special case and that the
possibility exists that pharmaceutical companies will be able to patent
other amino acids as prescription drugs.  What happened with tryptophan
was that MIT published their research without seeking a patent and that
resulted in tryptophan becoming unpatentable.  

As far as safety goes, my own point of view is that any time I take a
drug I'm ingesting an unknown substance.  When a doctor gives me a
prescription, I don't really know what that drug is.  One thing I can be
fairly sure of about a prescription drug is that it's not safe.  I can
choose to put my faith in the FDA that the dangers -- the side effects
-- are statistically outweighed by the benefits.  But I do know that
people suffer harm from these side effects all the time.  

I personally feel much safer taking a cautious dose of an amino acid,
vitamin, or mineral than I do in taking a prescription drug.  But I try
to be informed about anything I take and I agree with Wurtman that it
would be very nice if nutritional supplements were sold with informative
labels and package inserts.  (This is one of his arguments for why they
[at least in megadose form] should be sold as prescription drugs.)  


As far as smart drugs are concerned, Wurtman's remarks are much more
tentative.  He believes that choline is very important for memory and
other brain function but says there is as yet no evidence that any
substance improves memory or makes normal people smarter.  He flat out
says that Hydergine is ineffective.  

As I said, I believe that his article provides ammunition for both sides
in the sci.med FDA argument.  (Undoubtedly each side will disagree with
my assessment.)  It's only a few pages and I hope that people take the
trouble to find it in the library and read it.  

--
It is a poor sort of skepticism which merely delights in challenging
those claims which conflict with one's own belief system.  
                                                          --Bogus quote