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.... continued
from EVENTS LEADING TO
DEVELOPMENT IN THE U.S.A. OF Ultimate9.
The
Fountain of Youth
GH3 (Gerovital H-3)
has been called the fountain of youth, the miracle anti-aging
vitamin product, the total rejuvenator. These
claims are exaggerated but GH-3 has shown itself to
be helpful in these areas. It is actually a very
simple combination of two B vitamins, PAPA (P-aminobenzoic
acid) and DEAE (diethylaminoethanol) buffered and stabilized
with benzoic acid and potassium metabisulfite for more
effectiveness inside the body. The combination
of PABA and DEAE is a compound called procaine hydrochloride,
a vitaminic substance first synthesized in 1905 by a
German chemist, Dr. Albert Einhorn, who was looking
for a simple, non-addictive anesthetic. Today
procaine is approved by the FDA and used throughout
the United States under the trade name of Novocaine.
The
Miracle Begins
For years procaine
was used as a simple anesthetic, but soon researchers
began to notice other curative powers of this substance.
Interest in experimentation ran so high that between
1930 and 1951, over 165 reports were published on the
effects of procaine in the treatment of a variety of
conditions including arthritis, neuralgia, itching,
peptic ulcer, asthma and hypertension. In the
late 1940's three French physicians - Drs. Ghali, Boudon,
and Guoit - found that procaine hydrochloride helped
relieve suffering from asthma attacks. Dr. Rene
Leriche discovered that procaine injections were helpful
in treating certain forms of arthritis, arteritis, and
blood clots in the limbs.
PABA
and DEAE
Once in the body,
procaine breaks down into the B vitamin PABA and DEAE
which is converted to the B vitamin Choline in the cells
of the body. By itself PABA works mostly in the
glands, hair, intestines, and aids the body in
blood cell formation, protein metabolism and skin functions.
Studies have shown that a PABA deficiency can
cause constipation, depression, digestive disorders,
stress, infertility, fatigue, gray hair, headaches,
and irritability. Its function is to stimulate
the intestinal bacterial system to produce other B vitamins
such as folic acid, pantothenic acid, biotin, as well
as vitamin K. Ingesting PABA alone may not always
get results because it is rapidly disposed of by the
liver when in the free form. When nestled in the
procaine hydrochloride molecule, PABA becomes more effective.
The other part
of the procaine molecule - DEAE - has been shown to
have a definite anti-depressant effect. Double
blind studies by Carl Pfeiffer, Head of the Brain Bio
Center at Princeton, showed that DEAE produces mental
stimulation and mild euphoria, with no toxic side effects.
DEAE also comprises a part of two body substances
most important to the central nervous system, choline
and acetylcholine. Both are known to be basic
to the bodies stress reaction system. DEAE also
provides raw material for the production of cell membranes
inner and outer layers phospholipids.
Rejuvenative
Effects
The eminent medical
researcher Dr. Ana Asian, first noticed the rejuvenative
effects of procaine in her work at the Institute of
Geriatrics in Bucharest, where she was first appointed
as Director in 1949. Dr. Asian was able to duplicate
the work of Leriche and began to study the effect of
procaine on arthritis. Between 1949 and 1951,
Asian conducted animal studies and found that procaine
injections yielded complete cures in 85 percent of the
laboratory rats that had artificially induced arthritis.
Her first clinical tests produced the same results.
Dr. Aslan noticed that other afflictions rapidly improved
in their group of patients. Afflictions that could
not be helped by traditional methods. There was
an improvement in memory, a decrease in morbidity due
to Parkinson's disease and an increase in muscular power.
The psychological effects were also interesting.
Patients seemed to be more involved in life.
Intrigued by these
discoveries Dr. Aslan also began to improve upon the
basic procaine hydrochloride. She buffered and
stabilized until she came up with a far superior and
much more effective compound which she called Gerovital
H-3 or GH-3.
Improvements
and Test Results
With the perfected
GH-3, Dr. Aslan began ambitious experiments involving
twenty five patients in a three year study. That
year, 1951, the entire Geriatric Institute was turned
over to Dr. Aslan - a great vote of confidence for
her research. Three years later, in 1954 she reported
her findings in the Journal of the Romanian Academy
of Science. Patients showed greater vitality and
improvements in specific diseases when treated with
GH-3.
In 1956, at the
Karlsruhe Therapy Congress meeting in Germany, Dr. Aslan
presented the following final results; studies with
three groups of patients living at the Institute, each
group containing thirty to forty patients and 2,500
outpatients, showed that they were benefited greatly
by the use of GH-3. Dr. Aslan claimed that GH-3
relieved depression, hypertension, arthritis and angina
pectoris as well as producing muscular vigor and had
a "regenerative effect at the cellular level"
These results
were confirmed in several Romanian studies the largest
of which took place in 1970, when Dr. Aslan set up one
of the most carefully planned scientific experiments
ever. For two years, 15,000 people from the ages
of forty to sixty tow were tested at 144 centers throughout
the country. Although patients had all sorts of
jobs, both the control and treated groups received strict
medical attention including vitamin therapy. The
Gh-3 treated patients showed a significantly higher
degree of improvement.
Dr.
Alfred Sapse
Alfred Sapse had
interned as a young doctor in Romania and had seen some
of the seemingly miraculous results Dr. Aslan had with
GH-3. Said Sapse of the old people who were treated,
"Their ailments were either gone or greatly regressed,
at least to the point where they didn't bother these
old people. I saw these people before and after
treatment and I know what I saw. It was incredible
to me. I never forgot it."
Obsessed with
his memories of GH-3, Sapse followed studies of GH-3
and the aging process, through the years, from his position
as assistant professor in the department of immunology
at UCLA in the early 70's. A team of researchers
at the National Institute of Mental Health came up with
some definitive answers as to why depression occurs
among the elderly, which interested Sapse. The
NIMH team had shown that depression was caused by a
buildup of the enzyme monoamine oxidase(MAO) in the
brain. This was found to occur around age forty
five and to continue with age. The search was
on for a product that could inhibit this buildup without
destroying the natural usefulness of MAO in the body.
Sapse built his
case on research that went back to 1940-American studies
such as that of Dr. J.F. Philpot, who discovered that
procaine was a MAO inhibitor in the test tube. Back
then nobody knew what significance MAO had. As
soon as the NIMH studies came out, Philpot's discovery
took on added meaning and his results were soon confirmed
in Italy. Sapse took all these clues and worked
night after night on a computer to come up with the
basis for a full-scale U.S. inquiry into GH-3.
Studies
in the U.S.A.
Dr. Sapse gathered
together some top scientists for a battery of tests
on GH-3 that would, he hoped, end in FDA approval of
its distribution in the United States. His group
acquired exclusive rights for distribution from the
Romanian government, received an investigative drug
number from the FDA and then moved into action. Their
quest-to prove that GH-3 was a safe and effective anti-depressant
for the elderly.
The first study
confirmed that GH-3 was indeed a MAO inhibitor. This
test also showed GH-3 to be a weak and reversible inhibitor
that does no permanent damage to the MAO system. No
other anti-depressant was found to do this. Next,
it was shown that GH-3 gave "prompt and dramatic"
improvement in depression and insomnia patients already
under psychiatric care. The patients were also
found to have general improved sense of well being as
a result of the treatment. In addition, those
patients with high cholesterol levels were found to
have reduced serum cholesterol after only four weeks
of treatment.
Double
Blind Studies
Phase two of the
exhaustive GH-3 investigation consisted of double blind
studies in which the GH-3 would be tested against a
placebo with neither the doctor, nor patient knowing
which group received the real GH-3 until the end of
the study. The Kurland and Hayman double-blind
report at UCLA confirmed GH-3 to be more effective than
a placebo with no side effects in sixty four older patients
with depressive conditions.
In addition to
the first study, another test conducted by Duke University's
eminent researcher-psychiatrist William Zung, was actually
a triple-blind test because it included a group that
received the drug imipramine, a known and approved remedy
for depression. At the end of the experiment GH-3
proved to be superior to both the placebo and the
imipramine drug.
The final part
of the investigation consisted of GH-3 being tested
by twenty to thirty psychiatrists all over the country.
This was mainly to confirm the efficacy of GH-3
on a larger scale and determine if there was an allergic
response.
After three years
of study, the incredibly sound and positive case for
GH-3 had been made. Sapse was confident that GH-3
would soon gain FDA approval as an effective and safe
anti-depressant-among other important uses-and would
soon be able to alleviate the suffering and depression
of people in the U.S.
Politics
and Confusion in the U.S.A.
Ironically, it
is in the place where the best and most illuminating
research was conducted-America-that the mire of politics
and confusion would overcome the use of GH-3 and make
it impossible for further research to be conducted.
With the cooperation
of the Romanian government and a wealth of scientific
testing to back him up, Dr. Alfred Sapse was set to
market GH-3 as an anti-depressant upon FDA approval.
At the time however,
a tremendous amount of publicity came to bear about
GH-3 as an anti-aging substance. Although GH-3
had been tested throughout the world for the safety
of its rejuvenative properties, the FDA felt that not
enough research had been done in the U.S. to prove that
GH-3 was indeed useful against aging. The FDA
therefore demanded that Sapse prove that GH-3 was also
effective against aging.
Sapse appealed
this decision which would have taken millions of dollars
and many years of further research to prove. In
1976 the FDA agreed to the appeal. Wrote Ross
S. Laderman, chief of the Advisory Opinions Branch at
the Bureau of Drugs Division of the FDA, "This
decision was based on our feeling that there was no
evidence that Sapse was responsible for the extravagant
publicity surrounding Gerovital and it would be unreasonable
for the agency to require that the extravagant claims
be tested"
However, when
Sapse once again tried for approval the FDA stated that
Sapse should test the GH-3 with a younger population
as well as geriatrics. With this decision Sapse
could no longer continue financially. The additional
studies to fulfill the unreasonable expectations of
the FDA were estimated to cost many millions of dollars
and at least a decade of additional time.
Is the FDA's refusal
to approve the use of GH-3 based on anything more than
economical and political wishes? Who are they
protecting, certainly not the American people.
Since
that time GH3 has became legal to sale in the U.S.
Protected by Dietary
Supplement Act of 1994
GH3 is a dietary supplement protected by Dietary
Supplement Act of 1994. A ruling from a federal court case whether GH3 is a vitamin or a drug,
clearly placed GH3
in the category of dietary supplement.
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