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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.
P
rotected 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.

PAGE 3

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