From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: sci.med,sci.med.cardiology,misc.health.alternative
Subject: Dr. Harris Anti-FDA Rant, part I (was: Nitroglycerine - heart 
	stoppage?)
Date: 25 Feb 1999 11:21:26 GMT

In <36D2D06C.E0630DB4@emory.edu> Andrew Chung <achung@emory.edu>
writes:

>yep, I've seen the Bezold-Jarisch reflex happen (have broken out the
>external pacer while waiting for the TPA to work) in a subset of cases
>of acute inferior MIs.  NTG would definitely be a big no-no in that
>setting.

Comment:


   While waiting for the TPA to work, *after atropine has
failed*, of course.  But that goes without saying.  Nobody puts
in an emergency pacemaker for any kind of acute drug-induced
bradycardia without atropine going in first.

   Of course, there is reason to suspect, though we don't know
the precise mechanism, that Bezold-Jarisch reflex might be more
effectively suppressed or treated by any drugs which work in
the opposite direction to antagonize what induces it. Nitroglycerine,
as we now know, works on the receptors sensitive to nitric
oxide (NO) a natural short-lived free-radical signal molecule
made by the body to regulate vascular tone and inflammation (What
part of NO don't you understand? asks the Tee-shirt.  Viagra also
works by increasing the effects of nitric oxide).  When you slap
your skin and it turns red, it's nitric oxide dilating your
vessels.  Since nitric oxide has a half-life of about 10 seconds
in water, chemicals which block either its synthesis by nitric
oxide synthases (the enzymes that produce it), or chemicals which
just sop nitric oxide up directly, have about the same effect,
and about as quickly, on the effects of the naturally produced
molecule.

   And a variety of these modifiers are known-- there are nitric
oxide scavengers which stay in the vasculature and those which
get into the brain.  There are short-lived and long-lived ones.
The nitric oxide synthase inhibitors are specific or nonspecific
or the many isoforms of the nitric oxide synthase enzymes, and
they can raise blood pressure, or not (depending on what
condition and what chemical is being used).  A great many have
been tested in animals for shock and ischemia (in which NO is
produced by special inducible synthases), and are known to be
non-toxic at doses far larger, and for far longer, than would be
necessary to treat a drug reaction problem with nitroglycerine.
I can think of a dozen of them available from Sigma chemical
corp-- some of them very cheaply (a few dollars a dose).  Most
are not patentable because they have been around for years and a
lot is known about them from the general science literature.  I'm
not saying anything that isn't known by everybody in the field.

   The one thing all of these chemicals have in common is that
it's illegal to sell them as medicine.  And all but impossible to
use them that way.  That, courtesy of your FDA, which doesn't
allow medications to be sold it hasn't approved.  Which it
demands a lot of money to do, on a fast track (and which costs a
lot of money to prepare, even on the slow track).  Proprietary
and patentable derivatives of these drugs (some no doubt not as
good as the cheap molecules from Sigma Chem) are being madly
tested by many drug companies, of course.  And one day, many
years hence, at a cost of 250 million dollars to Novartis or
Lilly, one will reach the market at $300 a dose, for some other
indication (like septic shock).

   And at that point, doctors will begin to learn to use it for
off-label indications like Viagra or nitroglycerine toxicity,
just as they've had to do for most drugs (if you think, to use
our Dr. Chung's own example, that TPA was pre-approved by the FDA
for all the situations it's now used for, you have reading to
do).  In the meantime we'll have lost 10 years and thousands of
people, from many causes that nitric oxide blockers could have
been used for (ie, septic shock and not just Viagra ODs).  In a
rational world, doctors would just buy some of this cheap and
pure stuff from Sigma, and start using it on the worst cases (the
dying and the dead) NOW.  That's the way medical research used to
work.  That is, in fact, the condition in which medicine made
most of the progress you now see.

   But we no longer live even in that much of a rational world.
We live in a world where we now think that government should do
our thinking for us.  So if you'll forgive me, I'll use your
remark as a jumping off place for discussion of a larger problem.

My thanks here to Mike Darwin, who in our many discussions
contributed more than his share of thinking to what I'm about to
say, and has made many of these points quite clearly long before
I realized them.

   Look: the average guy on the street doesn't spend too much
time wondering what would happen to him if he should get the
Bezold-Jarisch reflex, okay?  And in reading your message might
assume that insertion of an emergency pacemaker is no big deal
perhaps do-able by anybody in an emergency department or
ambulance, and that development of a drug to reverse the problem
is not really much of thing.  And it is true that the problem,
while occurring in (what?) 1 in 10 or less of at-risk situations,
is still uncommon.  And also true that this problem only kills
people rarely (though I have the uncomfortable feeling that
people who die suddenly of arrhythmia while taking nitroglycerine
for chest pain are not that often written up correctly as being
the victims of the "Bezold-Jarisch reflex" on their death
certificates, even if this is what they indeed died of.  Call me
cynical).  But it's still a problem, so let's us it as an
example.

   Now, the people who really should be interested in this are
the folks who die of it.  But dead people make poor activists.
And their surprised families, of course, but who generally remain
uninformed.  A few more doctors understand the problem than
patients, but it's an uncommon doctor who knows about nitric
oxide modulators in development, unless that's his or her
scientific interest.  And even such people are not about to take
the opportunity of using a family's grief to educate them
politically, for many reasons.    Even if a physician was willing
to admit to a family that a patient might have died partly as the
result of a drug reaction to nitroglycerine, for instance, there
is still the matter of compassion.  By the time it is appropriate
to explain to a family a complex reason for a death, they are
long gone.  So a great many ethical and practical issues urge
even the uncommonly knowledgeable doctor to say nothing, in such
situations (sudden death).  And the uncommonly knowledgeable
doctor about the latest research on a particular problem is....
well... uncommon.  Medical knowledge is too vast for anyone to
know but a tiny, tiny fraction of it.  That you don't miss what
you've never seen, is a principle that works for doctors as well
as patients.  Thus, there is a lot of good activism for things
like AIDS and breast cancer, which kill people slowly, but
meanwhile they feel okay while knowing they have a bad disease.
There isn't much activism for stuff to resuscitate you from
cardiac arrest.  That's frustrating.

   So it happens that, as a doctor and researcher interested in
cardiac arrest and ischemic emergencies, the proper place for me
to take out such frustration with the FDA, is right here, not
with patients (when alive) or families.  I'm being chosen to
deliver medical care, not make people anxious or angry about
their congressman.  However, for each case of things gone wrong
there are things seen, and things unseen.  Here I discuss the
unseen cost of medical regulation.  And I'm going to keep doing
it, until people begin to understand, and policy changes.

    You readers DO realize that the FDA, until last month, argued
earnestly and seriously that only they had the ability to be
arbiters of truth in biomedicine?  And not the scientists who
develop scientific biomedical knowledge, or the doctors who put
it into use?  The appellate judge laughed them out of the
courtroom (thank Heaven), but the effect of the case is going to
be mainly on labeling of herbs and vitamins.  Big deal.  People
are not dying because the truth about echinacea or ginkgo is not
getting out (if you think so I feel sorry for you, and you can
stop reading right here).  People are dying of the same old
things, and those things are nasty, and in general, herbs will
not fix them (sorry to burst bubbles).  The kind of technology
necessary to rescue many people dying now from septic shock or
long cardiac arrest or multisystem organ failure, is indeed
foreseeable.  But it is not being developed, except at snail's
pace.

   An obvious reason for this is ignorance-- both about history
and about biology.  Education about both is abysmal.  It is
difficult to explain about nitric oxide and lack of appropriate
vasodepressor compensation to somebody who has no idea what the
sinus node is, or any idea of what a molecule is, or that blood
vessels constrict or relax.  And it's not just book-learning that
is worse, these days.  We squirrel away ill people in hospitals,
so the average person has direct experience only with a little of
what goes on there, and why.  This results in technologies
getting stuck in half-way mode because people don't see them--
and that's always expensive.   Half-way technology (to use Lewis
Thomas' term) is something that fixes the secondary effects, but
not the primary problem.  The closer you get to the source, the
less expensive is the fix, as a rule.  Iron lungs (a halfway
technology) are expensive, but a polio vaccine is cheap.  There's
where the lack of history comes in.  We're a society composed
increasingly of people who didn't live the history, and didn't
learn it in school, either.

   Back in the old days (like more than 50 years ago) people
understood a little of these ideas.  There was more self
reliance, more confidence in the idea of continual progress, and
it was taken for granted that people had to take care of more of
their own problems, and that the way to do it was research.
Polio vaccine development, for example, got paid for largely out
of pocket change donation (literally-- it was called The March of
Dimes).  But the world has changed a little too much since the
1950's.  The Salk Institute right now spends so much money taking
care of research animals according to government regs, that it
could not possibly run on pocket change.  And they surely don't
develop too many new vaccines these days-- they're paying too
many lawyers (they just paid millions to an animal care worker
who saw an animal suffer-- and more in USDA fines).  We also have
the new idea that the "best" medical care is a human right, and
everybody should pay for everybody else's, by taxation-- and
donations be damned.  Thus, the old incentives that used to exist
to spend medical care dollars wisely, are gone.  No one spends
any one else's money quite as careful as his own.

   The End Stage Renal Dialysis (ESRD) program, for instance,
seemed such a good idea in 1973, that the federal government
agreed to pay for use of artificial kidney machines for everyone.

Alas, a halfway technology par excellance.  They'd pay if you
were younger than 65 and didn't have diabetes, that is.  But that
seemed discriminatory, and so pretty soon it was available free
to anyone at all-- even demented 90 year old nursing home
residents who had to be tied down screaming when they got stuck
with the big needles.  Why not?  It paid as well as anybody.
Users rose exponentially in number (and 15 years in average age,
now approaching that of retirement) and pretty soon government
was spending 9 or 10 billion medicare dollars a year on 260,000
people (with insurance picking up half as much, in addition).
200,000 are on dialysis, and most of the rest have transplants.
Roughly a quarter of all these people die every year, and are
replaced by others, and the total slowly climbs.  And there the
situation stays, to this day, stuck in horror.  Mostly, you're on
the machine until you die, just as with the iron lung.

   It's a useful example.  Renal transplant patients cost just as
much and don't live any longer than dialysis patients, because
the anti-rejection drugs and infections kill them.  They do feel
better.  Alas, incentive to develop effective kidney transplant
rejection drugs is stymied by lack of organs, and for a very
similar reason to that holding up development in many sphere:
lack of incentive.  You can't pay for kidneys by law, and now
that cadaver organs don't go to the area they come from any more,
even transplant coordinators have no personal contact with, or
thanks from, the people they help procurement of an organ (by
persuading families to donate).  So, no organs.  With the FDA's
"help," research in this area has also largely stopped.  Animal
rights has played hob with it also.  There is a good chance that
kidneys from genetically engineered pigs would long have been
usable if that program had had half the money put into it that we
spend on dialysis.  And if animal research had not gotten so
expensive because of federal rules, genetic engineering hadn't
been slowed by federal rules and so on.

   Spending on dialysis treatment has been more or less capped,
to be sure (since otherwise all the rest of medicare would have
been eaten by this program), but that only means that those
200,000 people on chronic dialysis get a worse job of dialysis
every year, since the pie is sliced thinner and thinner with time
(a friend who used to be a dialysis tech says he's seeing
machines used on patients now that were obsolete in 1980-- so
it's true that you really can relive the past--- in government
funded medicine).  Technology in dialysis, far from improving
under open market incentive, is about where it was 20 years ago,
and has even regressed, since the incentive has decreased.
Technology has mostly gone backwards with the notable exception
of one pharmaceutical, Epogen, which cost the government so much
to buy for dialysis patients that they began to fear even
pharmaceutical developments in the area (cyclosporin and
monitoring and problems is one reason transplants still cost the
government as much as dialysis).  But, ironically, it is largely
government research regulations and social attitudes that make
development of drugs like cyclosporin and Epogen so expensive in
the first place.  So it goes.

   When the artificial heart came along, the government, fearing
another artificial organ debacle, killed it as rapidly as it
could.  Forgetting again, of course, that all technologies are
clumsy, unreliable, and expensive to begin with (I remember
quartz watches at $500 in 1972).  Technologies to do a particular
job only stay expensive if you actively force them by law to stop
developing, by making them illegal or otherwise removing all
incentive to do it (and sometimes not even then, if you look at
the illegal drug trade).  The first heart pacemaker was about the
size of a dishwasher, since it used vacuum tubes.  It was a big
deal in the late 1950's when a transistorized one came out that
could be *carried* easily by a person (in a case over the
shoulder-- i.e., watch for purse snatchers).  The emergency ones
referred to by Dr. Chung now have disposable electrodes, and the
generator is the size of a pocket calculator-- and that big
mainly for convenience.  Pacemakers to be implanted are the size
of a cigarette lighter, and they record EKG, and they contain
computers that talk to other computers over the phone about it.
That's the way things are supposed to go, and that's how they DO
go automatically in free market economies.  Again, you can't stop
it--- except actively.  Which is now what is happening in
medicine.  The idea that medical technology grows more expensive
is a self-fulfilling prophesy, made so by policy.  It didn't used
to, in medicine.  Left to itself, medical products would develop
like personal computers, and did so (see pacemakers, mostly
unregulated until very recently).  Now, as noted availability of
medical technology is actually regressing in some areas of
medicine.

   Which brings us to another reason for the problems with
medical research.  Unlike the case with personal computers, you
cannot have risk-free advance in medicine.  As has been said:
"Observe the turtle, who cannot go forward, except by sticking
his neck out."  And the risk in medical progress must be to both
animals (unless you want people to die in their place) and with
people (who take some risk no matter what).  A lot of dead test
pilots and other aviators, and even dead airline passengers,
stand behind every nearly risk-free trip in the modern big
commercial jet.  From Lindbergh crossing the Atlantic alone to
passengers doing it in 2 hours on the Concorde, was just 49
years.  And by that time a dozen men had walked on the moon.  But
then came a stultifyingly bureaucratic society that didn't suffer
dead astronauts, and certainly not dead space passengers.  As a
result, after 23 years more-- almost half the time from Lindbergh
to Concorde, we're still in Earth orbit.  Our commercial jets,
both over land and sea, fly no faster and are not greatly better.
No guts, no gain.  At this rate, the space shuttle will remain
dangerous forever.  And you and I will surely die of old age
before general tickets are available for space.  There is no
reason for this in physics.  It's purely a social problem.

   And, as a matter of fact, a lot of dead patients stand behind
most of the major advances mankind has made in medicine not just
transportation (the early dialysis patients, done by Kolff in
World War II Europe with a washing machine, died nastily of
unsuspected electrolyte problems).  But advances were made
rapidly.  Until they also began slowing the pace.  The golden age
of biomedical research is now ending (starting basically with the
Kefauver amendment in 1964, and taking an additional hit with FDA
medical device control a few years ago).  Thus, save for the
continued development of costly and proprietary new drugs, we as
a society are now largely coasting on the store of previously
accumulated knowledge in medicine.  We spend a trillion a year in
treatment, but mostly for drugs and half-way technology.  A
trickle (3 or 4% of this amount, total, public and private) goes
for medical research, and much of *that* is wasted to satisfy
bureaucratic restrictions.  And most people continue to have no
idea what has happened.  They know only that they're vaguely
dissatisfied with the state of affairs, and with what they get
for the money (usually an HMO run-around).  Routine medical care,
like the space shuttle, seems also destined to remain dangerous
forever. Some suspect a plot by the pharmaceutical companies.  It
is not.  It's just that progress has slowed and the population
aging has not, and what we're getting now is a smaller slice of
the politically correct and sanitized and completely red-tape
wrapped, child-safe, pie.


Continued in part II

From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: sci.med,sci.med.cardiology,misc.health.alternative
Subject: Dr. Harris Anti-FDA Rant, pt II (was: Nitroglycerine - heart 
	stoppage?)
Date: 25 Feb 1999 11:23:27 GMT

Dr. Harris Anti FDA Rant-- Continued from part I


   So if not a plot, what is it?  I believe it's a monumental
lack of willingness to take risk and responsibility, which has
now consumed our tort-producing and effete society.  Lawyers, the
favorite butt of jokes, are not the cause of it, but merely a
symptom.  Tort cases are brought by ordinary folks: if they don't
want to, no lawyer can make them do it.  And juries, not lawyers,
decide tort cases-- and juries are you and your neighbors, also.
The enemy is us.

   And this society is effete.  People used to live on farms, and
understood both that animals are not to be mistreated, but are
not as important as people.  Now they live alone or with no
children, often in city apartments-- and increasingly an animal
is the major recipient of their long term affections, and the
television their major source of education.  A research colleague
and I were recently in San Francisco for a scientific convention,
where the colleague remarked that San Francisco has now largely
gone to no-kill animal shelters, where all strays not adopted are
kept in clean and temperature controlled quarters with good food,
until they die of old age.  There were no stray animals on the
streets, indeed, but we saw a very great number of "stray," i.e.
street, people-- most living in the kind of filth and squalor
which, if found in animal care facilities in my laboratory by the
USDA inspector, would not only shut it down permanently, but get
me put in jail.  These street folks would in many cases LIKE to
have housing and food as nice as that in no-kill animal shelters.

Some of them eat dogfood anyway.  But we don't even have enough
no-kill battered wife shelters, let alone no-kill schizophrenic
street people shelters.  And government regulations for
cleanliness and flooring and surface engineering (ie, general
sanitation) of animal research centers, is considerably more
strict than it is even for nursing homes, where much of the
population is not house-trained.  Go figure.

   So we have indeed come to the point that those cute and furry
animals are cared about more than humans (except for the ones we
want to eat, of course--- but the rules change to draconian mode
for research rabbits and pigs, too).  And at my lab, because of
this, we spend our money mostly on paperwork and animal care
build-out to satisfy the government inspectors, instead of
research which will inevitably save lives when it is completed
(we don't spend federal research money, but that doesn't exempt
us from federal animal research laws).  Nor are we at my lab
alone in this: both my colleague and I noted that the pace of new
medical devices being advertised at this year's conference in
Society for Critical Care Medicine in San Francisco is down
drastically from the same one we attended two years ago.  The FDA
has clamped down on new device development, and the animal rights
people have made animal research, which is increasingly necessary
to satisfy the FDA before human trials, prohibitively expensive.
As are the human trials also (even for very benign things, like
nutrients, generic drugs, and GRAS = Generally Regarded as Safe
food chemicals).  Though not a conspiracy, these facts are
nevertheless connected.  The problem is that some of the
connections that are killing medical science progress are largely
invisible to the average man on the street.  And I don't just
mean the average man *living* on the street.  I mean also you,
Gentle Reader.

   Not to sound condescending.  I mean you unless, of course, you
spend a lot of time in biomedical research labs, hospitals,
clinics, ICUs, medical school libraries and classrooms, and at
medical science conferences, as I do.  I don't claim to be
smarter than everyone out there, but I do have a lot of
specialized experience with medical research and application.
So I can at least tell you the problems there, if not how to
definitely solve them.  Those of you with experience who disagree
with my opinions are welcome to chime in, and say why.

   We're a democracy.  Education is the only answer, if you want
to do something about this.  We have to talk to each other about
that which we know best.  Not that large a population reads
internet/usenet news groups, but some people do.  So taking out
my frustration here is the best I can do at the moment about this
particular situation.  We're all ignorant, but just about
different things, as Mark Twain said.  But we profit always by
talking to each other.  I suspect that most readers on this forum
have noticed that more and more time at their job is being taken
up by paperwork to satisfy some kind of government code, instead
of doing what the business was designed to (also, a larger and
larger fraction of you readers work on the government side,
making sure people do this.  Shame on you).  Advanced medical
care is not the only flower of human civilization being slowly
strangled this way.  It's just the one I happen to know the most
about.

   To go on with this, I'm reasonably sure (though here I
certainly leave my field of expertise way behind) that it's part
of a larger problem, and I'm soliciting comments on what it is
(my own guess precedes and follows).  As human beings we aren't
any more intelligent than we were 10,000 years ago when we
started to use agriculture and first started big cities-- we just
know a lot more.  But in the last 30 years in the United States
of America, it seems that with the compartmentalization of
society, the TV, and a much bigger government, we are each a lot
more ignorant of basic realities of life than people used to be,
even a few generations back.  And we are more socialistic and
less self-reliant.  And we seem, somehow, to have much less
courage, a virtue which Edward Abbey correctly notes must be
present, in order for any of the others to be worth a thing.

   About the middle of the 1960's something particularly bad
happened to the pace of progress in the US (this is when the
rocket *designers* started being laid off at NASA-- as someone I
know who worked there tells me-- and that's always an ominous
sign). It's still unclear what that Thing was.  But it started
then, and it got worse.  My own feeling, having lived in that
era, is that it had something to do with TV replacing books and
hobbies in the lives of children.  But I cannot say for sure.
Some say it was the fault of flattening economy and a war, but
perhaps that was as much effect as cause (for we as a country had
been through far worse).  I do know that I have seen a do-it-
yourself science project book from that era, which had things
like a cyclotron and X-ray machine you could make in your
basement.  And kids like me in the 60's really did things like
that, and things just as you see in The October Sky (movie
version of a book called The Rocket Boys).  And they blew
themselves up, occasionally-- which was the risk and the price.
Well, we as a society fixed it so you can't make cyclotrons in
your basement, or potassium chlorate rockets either.  But
strangely kids now die by misadventure in much larger fractions
than they ever did in that older era-- except they now die of
suicide and drug overdose and gunshot wounds.  This, in a society
much improved by better safety rules, and a larger government.
Hmmm.  Perhaps there was something more important we missed,
there.  Perhaps we couldn't see the forest for the trees.
Children need to spend their childhoods learning to be successful
adults.  That's increasingly difficult to be, and our children
work less hard at it than ever.

   And the same suggestion we missed our goal is true in the
adult world too.  The irony, of course, is that a world where
progress has slowed is NOT a safer world, but rather a far more
dangerous one by comparison with the one it could have been.  You
make no progress without sticking your neck out, as remarked, and
curiously that includes safety progress (do any of you know who
Colonel Stapp, the guy on the rocket sled, was?  A hero of MY
boyhood).  Had the pace of progress that obtained in 1965 in the
U.S. been continued, there is no reason why we would now have
anyone on dialysis-- these people would all have kidneys grown
for them out of their own cells.  The $14 billion the government
and insurance companies spend every year on dialysis and renal
transplants is enough to run almost the entire NIH budget
(basically, most of federally supported biomedical research).
But, of course, had we continued in our pace, adding it to that
budget would be a drop in the bucket, since instead of 4% we'd be
spending an intelligent fraction (like 20 or 30%) of our total
medical dollars on biomedical research.  At that pace, we would
long since know what was in the human genome, and we'd each
individually be in the process of changing the parts of our genes
we didn't like, to those of the healthiest people we could find.
And finding improvements on nature, too.  We WILL do all that, of
course. In time.  Just not you and me, and perhaps not our
children, either.

   We could have.  Instead, we got scared, and here we are,
aging.  And perhaps suffering, or watching our parents or other
family members suffer.  In many ways it's still 1970, except for
personal computers and cell phones and unimportant fashion
changes.  It's certainly NOT the Space Odyssey world Clarke then
quite reasonably projected for 2001.  Instead, housing prices are
horrible, violent crime is out of control, and medical insurance
rates are criminal for care that is no better.  And life is not
that much better, because we didn't dare pay the price we needed
to pay, to make it better.  The price of courage.  The price of
doing what wasn't easy, and doing it ourselves.

   The main progress we made since 1970 had to do with getting
free of government (we had shortly before gotten rid of "race
laws"-- a genuine improvement--- and now also got out of Vietnam
and the draft).  Otherwise, when we tried to go the other way and
legislate progress, things perversely quit happening as fast. It
was almost as though the legislators weren't as knowledgeable
about science as the scientists they wanted to control, or as
smart about business matters as the businessmen they wrote laws
to regulate, and so on-- a very curious thing.  In medicine,
there have been improvements since 1970, but mostly in
pharmaceuticals, where profits to some extent overrode
regulation; and in devices and surgical techniques, which spent
most of that time largely unregulated.  Now, with hugely
increased drug and device development costs, and with only
surgical progress left entirely to the surgeons (so long as they
use no new equipment), the pace in medical progress has at last
finally slowed to that in the rest of society.  You'll begin to
notice by and by, if you haven't already.

   Who is responsible?  Why, you and your neighbors, that's who.
If you have anything to do with animal rights--unless perhaps
your sole target was the meat industry-- you got us here.  If you
support the idea that whenever somebody has something everyone
else doesn't, that it's unfair and bad and should be fixed by
government, then you also helped get us here (see the 10th
commandment, as P.J. O'Rourke says, and Go To Hell).  Likewise if
you see government as a wonderful "partner" for intellectual
endeavors, and if you therefore support the full efforts of the
FDA, the USDA, the FCC, the FTC, the FAA, and any of the rest of
the alphabet agencies which keep people from making the progress
they naturally want, and need, to make.  Thanks a lot.  Far from
being part of the cure, you were, and are, part of the problem.

   What's the cure?  The cure, I modestly propose, is to
strengthen patent laws so that intellectual property is easier to
protect, and more likely to be produced.  As Mike Darwin points
out, intellectuals have mostly one product-- their ideas, and
those get stolen often enough.  After a lifetime of seeing others
make money on them, a lot of intellectuals (who end up teaching
to make a living) end up hating capitalists.  That is how
and why universities uniformly drift leftward, taking students
(who become the inheritors of power tomorrow, along with).  In
Germany in 1933, it was also how the non-Jewish German professors
almost uniformly ended up supporting Hitler.  A life of having
your best ideas stolen and turned into money by others makes
people who have ideas hate everybody, and particularly people
with money.  It's very bad for political systems, and it's
particularly bad for capitalism.  If we want to keep free
markets, we need to figure out stronger ways for people to own
the fruit of their intellectual labor.

   The second part of the cure is to leave other people the hell
alone.  They are, on average, as smart as you, and they know more
than you do about themselves and those parts of the world they
are interested in, and want to change and fix.  So leave them
alone so long as (of course) they aren't deliberately and very
clearly practicing violence or theft, in which case THEY aren't
leaving other people alone.  Otherwise, keep your nose out of it.
Certainly that's the cure for what ails medical research, and I'm
open to suggestions from other walks of life and slices of the
economy doing equally badly.

   Government, according to my view, is there to keep people from
imposing force or fraud on each other (but note that "fraud" laws
overcome arbitrariness only in cases where it's very widely
agreed as to what the Truth actually is, and should be written
accordingly).  Therefore, if you must burn your time doing good,
stand by and offer advice to your neighbor, which he is free to
reject.  Or give him charity.  But leave the law, and your guns,
and your fists, out of it.  And leave adults free to be
incredibly stupid, so long as their children aren't directly
involved.  "The effect of laws to protect men from their own
folly, is to fill the world with fools," writes Herbert Spencer.
And, as you will note from the rise of litigation, crime, teen
pregnancy, the quality of TV and books and newspapers and even
the people we elect for president, the fraction of fools in the
U.S. has been increasing these last 30 years, not decreasing.
That should tell us something.

   I do not know what the answers are to the country's problems,
but I do suspect that the fastest way to find them is to leave
individual people free to figure them out for themselves, which
mostly they did very well in this country, for centuries.  That
was before The State decided to run things at a microscopic
level, by means of representative legislators passing enabling
laws to allow a few guys in Washington offices to write
regulations with the force of law, intended to control the daily
actions-- mostly nonviolent and honest-- of people doing highly
technical jobs.  People who they've never met and know nothing
about, thousands of miles away.  How stupid can we be?  I know
what this has done to medical care, and as I look about me in the
country, I can find no evidence that the effect hasn't been much
the same on every honest and difficult business.  In the U.S.,
people still "own" businesses in title, but in practice the
government controls more and more of what you do, and can do,
with them.  There a name for that.  I don't like it any more than
you do.

   So may I suggest: Take a deep breath.  Then kill your
television.  And then make a mighty vow to mind your own business
more, and your neighbor's business less, when this involves doing
so by force.  If you do this, then perhaps--- just perhaps-- we
will one day actually get to the world described by Fred Pohl
(writing a personal history of science fiction writing), which he
calls _The Way The Future Was._  I'm a long time reader of
science fiction, and I want the way the future was.  The way the
present now should be, and isn't.  What about you?


                                 Steve Harris, M.D.

From: sbharris@ix.netcom.com(Steven B. Harris)
Newsgroups: misc.health.alternative,sci.med,sci.med.cardiology
Subject: Re: Dr. Harris Anti-FDA Rant, pt II (was: Nitroglycerine - heart
Date: 2 Mar 1999 12:24:04 GMT

In <36D594F4.A7823E23@dnai.com> Michael Sierchio <kudzu@dnai.com>
writes:

"Steven B. Harris" wrote:
>... [a] colleague remarked that San Francisco has now largely gone to
>no-kill animal shelters ...There were no stray animals on the streets,
>indeed, but we saw a very great number of "stray," i.e. street,
>people.... These street folks would in many cases LIKE to have housing
>and food as nice as that in no-kill animal shelters.

Kudzu
>You'd have to "violate their civil rights" in order to do so.
>Don't go conflating one problem with another.


Comment:
  Hey, bub, you're the one doing the conflating.  At no time did
I suggest locking these people up.  However, you do seem to be
suggesting that they're all out on the streets instead of at
homeless shelters, because they want to be.  Since the homeless
shelters in the SF are all full to overflowing, I think this
unlikely.  Possibly you're suggesting the world's most astounding
feat of city planning, in which everyone who wants to be in a
homeless shelter is, with no beds left unused, and the last guy
to get a bed is the last guy who wanted one?

   So far as animals go, it's not even really necessary even to
lock most of them up, if you really intend a no-kill facility.  I
can imagine a farm to which strays would be sent and fed, and I
suspect that under such circumstances, most would stay around.
Only those which insisted on straying, would be caged.  And I
suspect that kind of thing's next.  The issue is not confinement
vs no confinement.  The issue is care vs no care.

>The cynical decision to "treat" those persons in need of
>custodial care in an "outpatient" setting means that the streets
>of our cities have become open psychiatric wards.  The
>medication is usually not FDA-approved....

  Comment: a large fraction of street people are mentally ill (in
most studies, up to half).  But the rest aren't.  Which you will
discover if you bother to talk to them a bit.  And it is by no
means clear that all of the mentally ill ones want to be where
they are, either.  They just don't want to be in a psych
hospital.  Not making them go there is not particularly cynical.
I think, actually, that it was engineered by liberals.  Their
idea was that instead these people would be taken care of in
shelters.  But instead, they ended up building them for dogs and
cats, and blaming conservatives for lack of shelters for people.
Ah, those liberals.  When they put animals ahead of people in
public policy, and you call them on it, they ask who are we to
question their love.  And when the people in consequence suffer,
there the liberals are in protest, wondering how conservatives
could be so heartless.

>Permit me to assist you in pointing out that, if you argue
>against preference in affection (or ridicule it), you are
>arguing against the basis for affection.

   There you go.  See what I mean?  One cannot argue against the
basis of affection.  However, one can point out that most of us
would not want to operate a society and its rules out of personal
affections, which tend to be-- well-- personal and somewhat
unique and peculiar.  That's because most of us (unless tortured
by some kind of Hollywood radical chic-ism) don't really want to
force our own affections, which are idiosyncratic, on our
neighbors.  And that is what the law is: it is force.  If
necessary, deadly force.

   I do not use the word "care about" only in the sense of
affection, though that is part of it.  Caring in this sense is a
matter of duty and commonality and community as well.  It's what
we do (though painfully) that we hope (and thereby in some sense
expect) others would do for us.  I have a good deal more
affection for my cats, for example, than I do for the average
person I've never met-- and yet I would run over my cat if I had
to chose between my cat or a stranger in a bad traffic situation.
And if asked to vote for a law which chose between cats and
people on an equal basis, I would vote for people.  You see, I'm
not a liberal.  Liberals deny that such situations exist, because
the very idea of choosing between evils conflicts with their
CandyLand view of the possible world.

   Alas, the real world has limited resources.  And since they
are always limited, all laws force this kind of choice.  The
self-deluded pretend not, but you don't have to be prize winning
economist to see it.  For every animal shelter you build to keep
strays alive into old age, you don't vaccinate a certain number
of babies, pay a certain number of social workers to look after
kids who are beaten by their parents, or house a certain number
of battered wives or street people, or whatever.   There isn't
enough money to do all the social work everyone wants to do, keep
all living things in style, take care of our kids and aging
relatives, buy everyone a Christmas present, and take that
vacation to Hawaii.  If you leave out Hawaii, there still isn't.
We make such choices daily, though we pretend we don't.  It only
starts to get egregious, as I said, when our standards for care
set by law are higher for animals (lab animals, then even stray
animals) than for people (nursing home residents).  Which they
are.

   Note that I draw a line here between what you do with your
charity money, which is up to you, and what we as a society do
with our taxes (ie, that part of your money we decide isn't
really yours).  Which last, it would seem to me should at least
reflect values a little more common to us all.  Thus, it's one
thing, if you want to donate your million dollars to a home for
wayward cats, while people down the block are hungry.  It's
another, if the State forces you to do this.  It's one thing if
you're a bicycle mechanic, and you want to spend your spare money
building wind tunnels and giant kites, because you think you
could really build a flying machine when the experts had failed.
It's another if the state decides that giant kites are dangerous,
that you're no experts, and your extra money should go to the
community chest, where it can help orphans.

   I don't mind eccentric neighbors.  So long as they leave me
alone they can be amusing, and they may even be good for the
economy.  But I really hate eccentric cops and lawyers and courts
and legislatures and prison guards, and so on.  Eccentric
neighbors may be amusing or not, but eccentric laws are where
you're definitely not amused anymore.  The only reason the
average person puts up with the amount of eccentricity in the law
now is that the average person seems to be convinced that the
part of the legal/regulatory system he has to deal with most
closely, is particularly crazy for some reason-- but that
overall, the thing is okay, and most other people don't have to
put up with that kind of thing.

   That's why we have to talk to each other more.  Because the
thing is not okay.  It's going nuts everywhere.  The reason seems
tied up with our national mania, now that we've not had a
frontier in a century, in deciding that now that we're civilized
and the West is tamed, the perfect society can be legislated.
Probably into something like the Europe and Asia that people came
here originally to get the hell away from.  All it takes is
enough money, and you can fix anything, we figure.   Lost in the
shuffle is the reality that we don't have enough money.  Not by a
long, long shot.

>> I don't think we disagree (could be ignorance on my part)
fundamentally if you're implying that our collective behavior
does not have a rational basis.<<

   Nor a moral basis.  Nor any basis, except short term
greed and failure to want to take responsibility for one's own
actions.   It doesn't even have a pragmatic utilitarian basis,
because in the end our behavior is not going to result in the
kind of world that most of us want ourselves and our descendants
to live in, and think we're headed for.

   Unless, of course, you actually believe that animals are the
same as people in value, and should be treated as such, and that
laws which are aimed at increasing safety are okay in the short
term, even when it becomes obvious that they cause more danger in
the long term.  One cannot argue the fundamental bases of ethics,
but I have a much lesser goal.  I presume that most people share
my basic sense of values, but simply do not realize the long term
effects of social policy as it exists with regard to biomedical
research.

   If I'm wrong about that-- if they really don't give a damn
about their kids' leukemia or grandmother's stroke in 10 years,
if we can save the rat or kitty from the dread researcher now--
then I've had it.  There's really nothing to say.  But I have the
sneaking suspicion that most people think the scientific
community is out there madly trying to find a cure for cancer for
them, when they or their loved ones finally get it.  Wrong.
We're most of us mired in regulatory paperwork.  They (your loved
ones) are going to get cancer, or head trauma, or a short cardiac
arrest or whatever, and they're going to die from lack of what
we're not producing, when they could otherwise have been saved.
Because of the system in place now, which you aren't changing.
I'm saying that.  If you don't CARE, then fine.  However, if you
simply don't *believe* me, THEN we have something to discuss.

>Not to sound condescending. ...
>>Care for a little feedback? ;-)

   Nope.  Go right ahead.  I'm telling you what the world looks
like from my end as biomedical researcher, scientist, and
physician.  You're welcome to go ahead and tell me what it looks
like from your end.  If you think the government is doing a fine
job regulating what I do for a living, say so.  If you think it's
doing a great job regulating what you do for a living, say that
also.  And be man enough (or woman enough) to say what that is
you do, instead of sniping from the sidelines.  Mayhaps I know
enough about what your job's like to ask a few pertinent
questions you can answer.

>>I enjoyed most of your comments,  but must protest that your
(all too conventional) analysis on torts and litigation focuses
on the abuses of a system -- whose purpose is to ensure recourse
to those who are less capable, advantaged, etc.  and to make for
some form of accountability in those who might otherwise make a
cynical financial calculation about the value of someone else's:
life, liberty, health, etc.<<


Comment:
   Ahem, a "cynical financial calculation" about the value of
someone else's life, liberty, health, you say?  And what gives
you the right to assume it's "cynical" and not (say) passionate
and caring?  Or that what looks to be a financial calculation
necessarily involves a tradeoff between valuing money against
life, liberty, health; rather than a tradeoff between these and
what the money would otherwise be spent for-- which is the life,
liberty, and health of *somebody else* (very probably the money's
owner and his or her family, but not necessarily-- it might be
their pets and friends and favorite charities).  It is, in any
case, basically a question of valuing.  Of affection.

   And permit me to assist you in pointing out that, if you argue
against preference in affection (or ridicule it), you are arguing
against the basis for affection <g>.

   It all comes down ultimately to a question of whose money--
which is to say-- whose life and whose affections, is it to
spend?  If you say the individual's, I can only suggest then that
you individuals bugger off, and leave me, the privately funded
researcher, alone.  And if you say my money and my affection is
society's to spend, not mine, then may I suggest that society is
going to be shocked to find out the truth, which is that it's not
going to get what it really wants, if it keeps up present policy.
Society and I both want the same things, you see, which is cures
for medical problems.  I'm here to remind you that in the present
situation, they aren't going to be there when you need them.
That's not my doing, but yours.

                              Steve Harris, M.D.