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The FDA Ban of L-Tryptophan:
Politics, Profits and Prozac
By Dean Wolfe Manders, Ph. D,
Copyright, All Rights Reserved
This article first appeared in "Social Policy", Vol. 26, No. 2 Winter
1995.
Dr Manders has lectured and done extensive research on the medical
politics of L-Tryptophan.
The article also appeared in "Blazing Tattles" June 1996.

In the fall of 1989, the FDA recalled L-Tryptophan, an amino acid
nutritional supplement, stating that it caused a rare and deadly
flu-like condition (Eosinophilia-Myalgia Syndrome- EMS). On March 22,
1990, the FDA banned the public sale dietary of L-Tryptophan
completely. This ban continues today.
On March 26, 1990, Newsweek featured a lead article praising the
virtues of the anti-depressant drug Prozac. Its multi color cover
displayed a floating, gigantic green and white capsule of Prozac with
the caption: "Prozac: A Breakthrough drug for Depression."
The fact that the FDA ban of L-Tryptophan and the Newsweek Prozac
cover story occurred within four days of each other went unnoticed by
both the media and the public. Yet, to those who understand the
effective properties of L-Tryptophan and Prozac, the concurrence seems
" unbelievably coincidental." The link here is the brain
neurotransmitter serotonin-- a biochemical nerve signal conductor. The
action of Prozac and L-Tryptophan are both involved with serotonin,
but in totally different ways.
Elevated levels of serotonin in the body often result in the relief of
depression, as well as substantial reduction in pain sensitivity,
anxiety and stress. Prozac, as well as other new anti-depressant drugs
such as Paxil and Zoloft, attempt to enhance levels of serotonin by
working on whatever amounts of it already exists in the body (these
drugs are known as selective serotonin reuptake inhibitors). None of
these drugs, however produce serotonin. In contrast, ingested
L-Tryptophan acts to produce serotonin, even in individuals who
generate little serotonin of their own. The most effective way to
elevate serotonin would be to use a serotonin producer rather than a
serotonin enhancer.
The continuing FDA public ban of L-Tryptophan prevents popular access
to this most effective serotonin producer. The millions of Americans
who for decades safely have relied upon L-Tryptophan to relieve
depression, anxiety and PMS, as well as to control pain and induce
natural sleep, have been forced elsewhere for solutions. Routinely,
such solutions are pharmaceutical in nature: people are forced to use
either often highly addictive, expensive, and sometimes dangerous
drugs like Xanax, Valium, Halcion, Dalmane, Codeine, Anafranil,
Prozac, and others, or simply suffer.
Present FDA public policy maintains that L-Tryptophan is an untested,
unapproved and hazardous drug. The analytical work done a few years
ago by the Centers for Disease Control and the Mayo Clinic, research
which traced the fall of the serious flu-like condition to
contaminants found in batches of L-Tryptophan made by the Japanese
company Showa Denko, has not convinced the FDA to allow L-Tryptophan
back on the market. This decision is based primarily on the research
of FDA and NIMH scientists who state that L-Tryptophan itself,
irrespective of contaminants, is a dangerous substance. Other
university-based research scientists disagree with these findings.
The public availability of L-Tryptophan is too important an issue only
to be argued and shrouded within scientific debate that remains,
ultimately, mystifying to the vast majority of Americans. There are
many obvious facts worthy of public attention, and concern. For
example, consider the following:
On February 9, 1993, a United States government patent (#5185157) was
issued to use L-Tryptophan to treat, and cure EMS, the very same
deadly flu-like condition which prompted the FDA to take L-Tryptophan
off the market in 1989.
Notwithstanding its public ban and import alert on L-Tryptophan, the
FDA today allows Ajinomoto U.S.A. the right to import from Japan
human- use L-Tryptophan. Distributed from the Ajinomoto in Raleigh,
North Carolina, the L-Tryptophan is then sold to, and through, a
network of compounding pharmacies across the United States. Purchased
by individuals only under a physician's order, L-Tryptophan emerges
here as a new prescription drug in the serotonin marketplace; one
hundred 500mg capsules cost about $75.00, approximately five times
more than if they were sold as a dietary supplement.
Since the FDA holds the political mandate and power of a public
regulatory agency established ostensibly, to protect people from raw
corporate interests in drug production and distribution, the actions
of the FDA in concert with Ajinomoto U.S.A. are illuminating. By
publicly banning L-Tryptophan from its dietary supplement status and
price, while allowing L-Tryptophan to be sold as a high-priced
prescription drug, the naked duplicity of the FDA L-Tryptophan policy
is revealed.
During and after the 1989 EMS outbreak, the FDA did not totally ban
the use of L-Tryptophan in humans -- then , as today, the FDA has
granted the pharmaceutical industry the protected right to use
L-Tryptophan in hospital settings. Manufactured by Abbott
Laboratories, the amino acid injectable solutions Aminosyn and
Aminosyn II contain as much as 200mg of L-Tryptophan. (Moreover,
L-Tryptophan has never been removed from baby food produced and sold
within the United States.)
While the FDA has banned the public sale and use of safe, non-
contaminated, dietary supplements L-Tryptophan for people, the United
States Department of Agriculture still sanctions the legal sale and
use of non-contaminated L-Tryptophan for animals. Today, as in the
past, feed grade L-Tryptophan continues to be used as a nutritional
and bulk feed additive by the commercial hog and chicken farming
industry. Additionally, L-Tryptophan is now available for use by
veterinarians in caring for horses and pets.
Outside of the United States, in countries such as Canada, the
Netherlands, Germany, England, and others, L-Tryptophan is widely
used. Nowhere, have any serious or widespread health problems have
occurred.
At bottom, the FDA public ban of safe, non-contaminated L-Tryptophan
is uneven, expensive, and biased in favor of the pharmaceutical
industry. The FDA proscription effectively awards billions of dollars
in profits to pharmaceutical companies and their suppliers in the same
proportion as it adds billions of unnecessary dollars to the nation's
already bloated health care expenditures.
On June 15, 1993, the FDA Dietary Supplement Task Force published a
report on the work it had been doing in the area of developing FDA
policy around nutritional supplements. On page two, the report admits,
"The Task Force considered various issues in its deliberations,
including ... what steps are necessary to ensure that the existence of
dietary supplements on the market does not act as a disincentive for
drug development."
In this case, the FDA has succeeded in carrying out its stated policy
goal. With competition from publicly available L-Tryptophan removed,
the rapidly expanding market in prescription serotonin drugs-- now
among them L-Tryptophan itself-- contains no major "disincentives" for
the massive accumulation of pharmaceutical industry profits.
It is now time for appropriate congressional committees to review
openly and aggressively the entire matter of L-Tryptophan. This will
provide a needed forum where political, corporate, and scientific
issues of the FDA L-Tryptophan regulatory policy may be addressed.
There exists ample precedent for such hearings: in the 1980's and
early 1990's, for example, such investigations uncovered favoritism in
the approval of generic drugs and the bribery of FDA officials.
The story of L-Tryptophan illustrates a sad perverse picture of the
politics and priorities of public health in America: A safe,
dietary-supplement serotonin producer is publicly unavailable to
people, while daily fed to animals by corporate agribusiness. A patent
is approved to use L-Tryptophan to cure the very condition the FDA
claims it caused. And, while publicly exclaiming that L-Tryptophan is
a dangerous and untested drug, the FDA more quietly, allows human-use
L-Tryptophan to be imported, and then marketed and sold by the
pharmaceutical industry.
To allow the FDA ban of L-Tryptophan to continue unreviewed and
univestigated condemns millions of Americans to unecessary financial
expenditures and needless suffering.

peter moran

<snip>.

Even if all this were true and the ill effects previously noted from
L-Tryptophan were from contaminants in the manufacturing process (no, it
doesn't come from a herb), there is a lot to be said for not allowing open
slather marketing of this amino acid by the supplement industry. The latter
has a long history of poor manufacturing practices including adulteration
of products, variation in drug content, and presence of contaminants. No
examination of any of its products has ever failed to show some such
problems. The manufacturers seem to know they are selling junk to the
gullible, and so why bother with quality? There are exceptions.


Peter Moran

jeff

Thanks for reminding us that the FDA is doing a good job of keeping deadly
drugs off the market. Too bad all drugs don't have to go through the same
rigorous testing that drugs allopathic drugs have to go through to prove
that the drugs work and are safe.

Jeff

william a. noyes

"Allopathic" drugs of the older NSAID class will cause gastric
bleeding in 3 to 5% of users when taken over prolonged periods.
Indeed, I'll suggest the number goes higher for those
taking this class of drug as the years go by.
Even ephedra was much safer than that,
(though I never supported ephedra use as a
stimulant or a weight loss aid). Further, in the ephedra deaths,
its use in extreme circumstances and in dose far beyond
the recomended dose of played a role. Yet, in traditional
medicine, it has a place in the TX of
COPD and asthma as I recall.
I've seen COPD sufferers use it to good effect for
significant intervals in their years long decline to death.
Eventually, they went to more conventional medicines and
concentrated O2. The point being is that alternative and
complementary medicine can be useful and should not
be banned by the fools and bigots who seem to think
Big Pharm is of pure motive and GPs know all.

There is no significant funding mechanism for off-patent compounds
mainstream or alternative. The term "allopath" belongs to the 19th
century as does John T. Whale. The mainstream advance in
preventative medicine, geriatrics, nutrition, and even applied
endocrinology has been sluggish, IMO. Just look how the mainstream
has botched the application of estrogen replacement therapy,
a perfectly good idea (as any idea can be in an imperfect world).
The use of only estrone and E2 rather than E3. The failure or sluggish
acceptance use androgens in womens hormone replacement.
The use on hormone analogs when the natural unpatentable form would
have been better.

While John T. Whale is an idiot, he is an idiot that serves
the interests of Big Pharm as he is a soft target. He is
the ultimate straw man to do battle with.

The FDA has done a job.........but it hasn't always been
good.


The forum misc.health.alternative is a vast waste land
It should be declared Aaron-Fox-Land and
be deleted from the grand Google record.


William A. Noyes

jeff

Which is why the use of these drugs over prolonged periods should be after consulting a physician.

Based on what evidence?


I disagree. So does the FDA. I don't think the use of ephedra is safe at all.


There are newer, better drugs available.

The nature of the progession of the disease.

Too bad so many people smoke.

I did not know anyone thinks that big pharm is of pure motive or GPs know
everything. Big pharma exists to make money for its stock holders. And GPs
don't know everything. Otherwise, we would not have specialists.

The fact is that "alternative" and "complementary" treatments (I won't
insult the docs here by called these treatments "medicine") are unproven.
The terms "alternative" and "complementary" were invented by their
practioners and marketers to make it seem like they are a ligitimate part of
medical science. While some have a ligitamate role to play in medical care,
the vast of majority, IMHO, of what is called "alternative" and
"complementary" is really quackery.


In part, thanks to the insurance companies who don't pay for much preventive medicine.


Why would "natural" estogens have been better? Natural does not mean better.


Unfortunately, too many people listen to John. He is no idiot. Terribly
misguided, yes, but not an idiot. (Besides, I would not want to insult the
real idiots out there).

True of any organization. But we are much better off with the FDA than
without it. The FDA has decreased the time to market for drugs, investigated
numerous outbreaks of drug-related disease (like the L-tryptophan thing),
and done a pretty good job, IMHO. Not perfect, of course. I have yet to see the perfect human enterprise.

I don't know. I never wasted my time there. Jeff

william a. noyes

NSAIDs are often handed out with very little adverse event advise
from the Doc and the Druggist.


It is becoming a pretty standard practice to protect the GI tract
of NSAID users/patients by prescribing either an H-2 blocker
or a PPI med. Give me a break, NSAIDs are known causes
of GI damage and gastric bleeds.

The comment "Based on what evidence?" is the question
that a Doc wouldn't ask, IMHO.


I somewhat disagree.

True, I suppose though in some instances people have grown there own.
Cheap for those in that situation.

Note to that traditional Chineses medicine was exempted by the government.


yes and yes

Albeit, COPD can be seen in non-smokers deficient in
alpha-trypsinase, in asbestos exposed worker,
and in a range of dust and toxic gas exposures both chronic and acute.


I would "insult". Read up on the use of inositol in panic attack and
OCD. And example the alternative medicine that is nearly non-toxic
and more effective in some patients than the standard meds.

I could provide you with a list but I don't think you give
specific comments based on clinical observation, anecdote,
double blind studies, or cross over studies. So one
example is quite enough for you.


Private health insurance companies are part of the problem as they have
redundant
expensive private bureaucracies besides having the need for
profit for share holders or owners.


better.

Now Now you are focusing on the wrong steroid for that issue. That comment
was directed at certain androgens ie methyltestosterone and certain
progestins.

It depends on the situation. SERMs have there place in medicine.

I note you didn't comment on the failure of mainline medicine to use
E3 in ERT.

Yes, misguided is a better term. John in my view is a marginal
character who quotes others who are at times the real opinion
makers. He is rather like Doe on sci.med.nutrition who is
on target on occasion if only by accident but who is often
just wrong. I think you over-estimate the influence
of Usenet forums.

I Googled you, Jeff aka Jeffrey Peters, aka Jeff Utz.
You have spent a lot of time on the misc.health.alternative
forum though you seem to have lots of postings
to misc.kids.health as well. You should know who
AF was as you were around 'back in the day.'
You don't seem to have a very wide range of posting
interests unlike Steve Harris or even myself.
You don't seem like a physician. Nor you have
a habit of citing sources as far as I have seen.


William A. Noyes

whaleto

John T Whale? Is that me.

Allopath is an excellent term for drug using medical doctors, as
opposed to ones who use nutrients, naturopathy, homeopathy etc. I
know allopaths, having a medical monopoly, want people to think there
are only one type of doctor, them, but it's is just propaganda.

Nutient med will replace 98% of drug med when the truth gets out
eventually. eg budwig diet http://www.whale.to/cancer/budwig.html
vitamin c for heart disease--reverses that

you can see why drugs hold sway--money