X-Message-Number: 1486
Date: 22 Dec 92 05:36:11 EST
From: "Steven B. Harris" <>
Subject: The FDA & Saul Kent

Dear Cryofolks:

   In the recent debate we've heard some egregious remarks about
Saul Kent and the FDA, and I thought it time to address both of
these subjects from a different perspective, just to balance
things out.

FDA

   I'll start with the FDA.  The Food and Drug Administration was
originally (early in this century) charged with establishing the
purity and safety of foods and drugs.  As such, it was tolerable,
and even did a certain amount of good in acting as policeman
against certain types of actions which we all agree constitute
"fraud" (putting horsemeat in the hamburger, putting sugar
instead of antibiotic in the antibiotic pills, etc.)

   Then, something horrible happened.  A tranquilizer drug called
Thalidomide caused a number of deformed babies in Europe.  The
woman commissioner of the FDA at that time, Francis O. Kelsey,
M.D., had a pharmacist husband who did not like the way the
routine pharmacology tests had been done on Thalidomide (some-
thing having nothing to do with reproduction), and by the
sheerest chance the resulting red-tape holdup by the FDA caused
introduction of Thalidomide to be delayed in the U.S., until it
become apparent in 1960 that it was a dangerous drug.  Following
this, JFK gave Dr. Kelsey a medal for basically being a bureau-
crat and allowing Europeans to be guinea pigs for Americans, and
everyone congratulated themselves, without thinking too much
about what the consequences of such an across-the-board delay
policy might be, when applied to all new drugs.  In 1962 a new
congressional law gave FDA power over not only safety, but also
efficacy of new drugs, and the regulatory monster that we know
today was born.

   And a monster it is.  Today, mostly because of FDA-caused
foot-dragging, the cost of developing a new drug has risen to an
average of about a quarter of a BILLION dollars in the U.S., a
price which the consumer pays when he/she picks up any prescrip-
tion for a newer drug (if you want to directly assess the regula-
tory cost of the FDA, try buying pharmaceuticals in Mexico
sometime, and note that they can be, for the identical product
made by the identical company, sometimes 1/10th the price).

   The regulatory cost in lives is more difficult to assess, but
is probably significant.  The high cost of drugs caused by heavy
regulation has led not a few poorer people to stop taking what
the doctor ordered, sometimes with expensive or even tragic
results.  Even worse, new drugs now are quite often available in
Europe for years before being available in the U.S., and in the
interim patients die for lack of treatment.  For instance, one
estimate puts the number of people who died of heart conditions
as the direct result of the historical FDA's multi-year lag-time
in evaluating beta-blocker drugs in the hundreds of thousands-- a
number which makes up for Thalidomide many times over.  

   It is important to understand that this situation arises via
one of the significant shortcomings of democracy.  Politically,
the FDA comes under severe pressure for passing a drug which is
later shown to be unsafe, but much less pressure for the equally
dangerous failure to pass a drug which is later found to be
efficacious.  This is because patients who die as the result of a
drug-reaction are seen to die because of the drug, but patients
who die as the result of lack of a drug (especially one which the
local docs are not familiar with) are seen to die of the *dis-
ease*.  And even if the local doctor understands the FDA's role
in preventing the patient from being properly treated, "Stenosis
of the Government" is not a medical diagnosis, and cannot be
written on a Death Certificate.  

   It is also important to understand that this situation arises
because of a certain laziness of the citizenry in understanding
that the decision of whether to take a specific drug for a
specific purpose, is only partly a scientific one.  The reason
for this is that, even if (rare case) the probabilistic risks and
the benefits of "taking the drug vs. not taking it" have been
defined by science, the *balancing* of these risks and benefits
is still an ethical and moral decision, and one which varies
wildly from person to person, due to circumstance and personal
preference.  

   To put it succinctly, the decision to try a new and possibly
dangerous treatment may well and properly be influenced by how
much pain the prospective treatment-taker is in, and how soon he
or she can expect to die if nothing is done.  Unfortunately,
however, these factors do not enter into decisions made in
Washington, D.C., basically because Washington, D.C. is not in
pain, and Washington D.C. is not dying.  If you are the patient,
then, you may expect that having a decision about your treatment
made for you in Washington will not be satisfactory, because they
do not know you or your problems in Washington.  Nearly any dis-
placement of medical problem decision-making from patient and
physician toward a place thousands of miles away, is bound to
result in needless suffering.  Thus, the FDA as it functions
today is basically engaged in an evil enterprise.  The people who
run the FDA may not be evil people (though surely some are) but
unfortunately, this does not change the facts about the FDA's
general impact upon the world.

   The FDA, remember, is in the game for the political power, not
for the benefit of the citizenry.  Thus (for instance) the FDA
will not permit any information about the *dangers* or possible
side effects of particular herbal preparations to be printed on
the bottle label, even though such warnings might do much good,
because the FDA does not want to set the precedent of providing
usage information of any kind on bottle labels.  Damned be the
consumer.  In another case, the FDA has consistently, for more
than ten years, prohibited vitamin companies from making claims
about the ability of the vitamin folic acid to prevent certain
birth defects, while evidence mounted all the while.  This year
the American Society of Pediatrics formally recommended that all
women of childbearing age take a supplement of folic acid, yet
still the FDA will not permit vitamin manufacturers to inform the
public about folate.  Since there is no place the FDA can hide on
this issue, however, it now seems likely that, rather than admit
that the claims for a single vitamin supplement pill were
correct, the FDA will soon *mandate* adding folate to flour as
part of the enrichment process.  We thus seem likely to go very
soon from a situation where manufacturers are prohibited from
telling of the benefits of supplementation with a vitamin,
directly to one in which manufacturers are obligated to add that
same vitamin to your food without your request.  Going from
prohibited to required without going through the intermediate
state of individual choice is a nice illustration of the way our
government thinks, to be sure, but in the meanwhile, while all
this is sorted out, more children will surely be born deformed
because their parents lacked information on supplementation. 
Once again, however, the mission of the FDA is power, not the
prevention of birth defects.  Anyone who still thinks otherwise
did not learn the right lesson from Thalidomide.


Saul Kent

   Which brings us to Saul Kent.  Saul Kent is presently locked
in legal battle with the FDA over charges that he made "illegal
claims" for certain vitamins (actually, any claims for vitamins
at all are illegal) and that he imported substances which
according to the FDA are "pharmaceuticals" instead of "nutrients"
(like CoQ10).  All of the issues which Saul and the FDA differ
are those upon which knowledgeable people might reasonably
differ, and none involve what you and I would consider out-and-
out fraud, yet Saul is under indictment for federal vitamin
crimes enough to send him to jail for the rest of his life and
more (I'm not kidding).  Such is the sickness of the FDA. 
Interestingly, there is nothing which Saul has been indicted for
which is not now routinely practiced by a great number of AIDS-
drug "buyer's clubs" in this country, yet the FDA (for reasons
purely political) leaves the AIDs-drug industry and community
pretty much alone.  Such is the *slickness* of the FDA.  Again,
please see what I said above about power.

   Which brings me to the subject of empathy for Saul's plight
among a number of cryonicists on this forum--- the singular
absence of which is astounding.  Wake up, everyone.  If you're a
cryonicist and you're NOT upset over the idea of the governmental
suppression of what it considers quackery and false medical
claims, then you'd better sit down for a minute and take stock of
your basic philosophy.  As a cryonicist you've got a little
cognitive dissonance coming.  The FDA is not your friend.  In
fact, since the FDA does not consider "aging" a "disease," and
therefore would not consider the licensing of any drug which was
found to combat aging, the FDA is your sworn enemy.  It follows
that anyone who *fights* the FDA deserves the gratitude of every
thinking cryonicist.  Anyone.

   Saul Kent, of course, is not just anyone, but also one of us. 
He has not only been a cryonicist for almost 30 years (he was
Secretary for the Cryonics Society of New York before many people
on this forum were born), but he is also probably the single
largest benefactor of Alcor.  When Alcor faced an eviction notice
due to insurance problems in 1987, and could not find rental
anywhere else due to the same problems (this meant the end of the
organization and potentially the loss of the patients), it was
Saul who largely organized and engineered the Symbex bailout that
got us our own building.  That Saul's recent fight with the FDA
has diverted his money from cryonics support to lawyer support is
a tragedy and a personal loss to every cryonicist, and one they
should blame on the FDA, not Saul.  

   No, Saul is not going to be funding cryonics from a jail cell,
should be find himself in one.  Anyone who thinks so should think
again.

   There has been a certain amount of griping on this forum about
the political pull of Saul at Alcor, but I only see this in terms
of the fact that cryonics is not a democracy, nor is meant to be. 
Does Saul have too much power?  I don't know.  I do know,
however, that if political power were given out solely in terms
of how much lifetime and money and commitment an organization's
members had spent in its service and the service of its ideals,
then Saul would surely have relatively MORE power then he
presently has in Alcor, not less.  On the whole, I don't think
it's something to worry about too much.  

   The power of the government, on the other hand.....now that's
something to worry about.

                                          Steve Harris

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