H3 Book Index:: Chapters 1-29
Despite the denunciations by the British MedicalJournal (Prof. Aslan is a "woman gifted with humor, charm, enthusiasm and boundless therapeutic optimism but she had failed to meet the necessary scientific requirements... before any claims could be made"), and the American Medical Association in the Journal of the American Medical Association and elsewhere, GH3 refused to go away. In England, recognition came relatively fast: as early as 1966, the Dunlop Committee on Drug Safety (in certain respects the counterpart of our FDA) had it cleared for general distribution. As in most other countrjes it is available in English pharmacies without a doctor's prescription.
The FDA mills worked considerably slower. It was not until 1970 that animal experiments to prove the drug's safety were approved and clinical tests did not get under way until May 1972 and were then restricted to only one indication: depression. The first reports by reputable scientists were so positive that the drug's fmal approval seemed to be close. Just when this was expected several news articles appeared
implying that GH3 was influencing the aging process.
Immediately the FDA asked for proof that indeed it did prevent aging-obviously something that could only be proved clinically in many years' work. Thenthe FDA reversed itself once more. The Rom-Amer. Co. which had tried to get the Rumanian drug approved, ran out of steam. The many years of waiting and carrying out costly testing, had eroded its financial basis.
Melvin Krattar, a Nevada businessman, who hadtaken H3 in Europe to help him fight depression following life-threatening heart surgery, bought the company late in 1976. He lobbied the Nevada legislature to let H3 go the "Laetrile" way and legalize manufacture and sale in Nevada. (Laetrile, an anti-cancer drug, also banned by the FDA, over the last year has been approved by the legislatures of fourteen states, and 24 more are considering such action in 1978. A Federal
judge in Oklahoma has even decided that the FDA has no right to bar access to this drug to a terminal cancer patient thus, for all practical purposes, legalizing its use nationwide-provided his decision will not be overturned by higher courts.
Kratter then discontinued the promising tests, withdrew the pending FDA application and made preparations to dispense the treatment in Nevada. At this writing no one knows whether Kratter will be successful in attracting enough people to the Sagebrush State to make his gamble pay. The foot, however, is in
the door, and theoretically at least, other makers of
procaine preparations could also use Nevada as their American base, hoping to convince other state legislatures to follow Nevada's lead, as in the case of Laetrile.
In the press it was reported that Daniel J. Demers,
majority leader of the Nevada State Assembly, declared: "The evidence in support of GH3 was simply overwhelming-from doctors, clinicians, pharmacists and patients throughout the United States." One of the doctors quoted was Dr. Abraham H. Rudnick, a Las Vegas cardiologist, who stated that he had used on thousands of patients.
People suffering from depression, a frequent concomittant of old age, when taking H3 are "more at ease, more rested, more able to cope with events in their lives," said Rudnick. "They are less preoccupied with aches and pains. It improves their mental psyche. "
Dr. Keith S. Ditman of the Vista Hill Foundation in San Diego reported on a GH3 test with 170 patients of whom "the vast majority" showed a higher sense of well-being, more energy and relaxation, and improved sleep.
The FDA, at least momentarily outwitted, has already threatened action should raw materials for the drug be brought into Nevada from outside the state or
some of the finished product taken out of Nevada. That the agency might not shy away from such action, can be deduced from its attitude towards Laetrile: In Wisconsin and Tennessee according to science writer Lee Edson, writing in the New York Times Magazine, "its agents recently swooped down on several farmers and confiscated sacks of (apricot) pits," out of which Laetrile is being made. "The FDA asks apricot growers to inform them of what seems to be illicit apricotpit traffic, and has been reported to use helicopter surveillance against the enemy pit."
The reluctance of the FDA is not easy to explain, but there is no doubt that this agency is criticized by the pharmaceutical industry for being too cautious and by consumer advocates to be in cahoots with the in
dustry it is supposed to regulate. Both sides can marshal enough evidence for their point of view. But the fact of the matter is that today it takes from six to eight years and many million dollars to get a drug approved for sale in the United States.
In a recent magazine article the Noble Prize-winning economist, Dr. Milton Friedman of the University of Chicago, stated: "The FDA has done more harm than good. The reason is very simple-no Food and Drug Administrator has ever been pilloried for not
approving a drug which was potentially capable of saving many lives."
Prof. Friedman continued: "Any Food and Drug
Administrator is bound to be pilloried for making the other mistake, namely, approving a drug which turned out to be harmful. As a result, the Food and Drug people have a bias in holding up good drugs in order to avoid the possibility of mistake in approving a bad one. The result is that there are many effective drugs which are available in Canada, in Britain and elsewhere which cannot be purchased by people in the United States, but which might very well save their lives. ..
Could it be that the procaine preparations are among those drugs Prof. Friedman has in mind? And if
so, what can now be done after the most promising test series has been discontinued, to bring about their availability in this country? No answer can be given to this question, but in the absence of affirmative action
by the FDA we will now briefly survey the results of various tests undertaken in the United States.
The first papers in this country reporting successes with procaine came in the sixties. Psychiatrists Luigi
Bucci and John C. Saunders found in 1960, in a study of 25 psychotic women that procaine is "effective in alleviating depression and reducing psychotic symptoms associated with schizophrenia." Four years later, also in the Journal of Neuropsychiatry, psychologists Dr. Solveig S. Gislason and Dr. Robert F. Long reported that procaine "improved performance in orientation, attention and memory" in 33 totally disoriented patients.
Only in recent years when, under the overall supervision of Dr. Nathan Kline, Associate Professor of Psychiatry at the Columbia University College of
Physicians and Surgeons, the systematic testing of GH3 with a view of gaining FDA approval began, did new reports on the efficacy of the drug in fighting geriatric depression come in. Kline himself said that neither in 40 humans nor in rats given up to 60 times the optimum dose of procaine had any side effects occured.
The general impression was that most of the patients improved as the treatment went on but no attempt was made in this phase of testing to evaluate the results statistically.
Two additional studies were undertaken at the Duke University Aging Studies Center in Raleigh, N.C. Two trials were undertaken with the same group of 30 patients, nine of whom received Gerovital H3, eleven the standard antidepressant imipramine and ten a placebo. All were "mildly ill" with depression, and the average age of the three groups was 67.2, 68.4 and 68.7 years, respectively. Dr. William Zung, professor of Psychiatry, reported that five ratings were taken to assess the progress of the patients during a 28-day course of treatment. On the self-rating depressionscale and the self-rating anxiety scale GH3 worked considerably better than either the other drug or the placebo while in'the other three there was no statistically significant difference.
In the second Duke study Prof. H.S. Wang examined the effects of GH3, imipramine and a placebo on various neurophysiological criteria and found no great difference in the effects of GH3 and imipramine but thought that the former might be safer for elderly patients.
The same ratings as in the Duke University trials were used at the Desert Hospital Mental Health Center in Palm Springs, CA in testing 33 patients on
GH3 and 30 on a placebo. The Center's director, Dr.Max Kurland reported, according to Medical World
News, "we got some very positive results. They were statistically significant for all five evaluations we used." Other investigations were carried out at the Universityof Southern California in Los Angeles and at McGill University in Montreal.
That's where the matter rests for ,the present since all tests have been discontinued. Except for one other
quite important contribution: Observing the effects of
procaine on the aging, no one knew much about the mode of action of this ubiquitous drug. At the annual meeting of the Gerontological Society in Miami Beach, in November 1973, two investigators from the University of Southern California reported on their independent research concerning the mechanism of pharmacological action of GH 3. Professor M. David MacFarlane found that GH3 alters the activity of an enzyme essential to the control of brain function, monamine oxidase or MAD. This enzyme controls the
rate of destruction of essential compounds, so-called neurohormones in the brain, nerves, and other human tissues. Its activity increases progressively after age 45. As the levels of MAG activity increase, the rate of destruction of the neurohormones results in lower neurohormonal levels.
The consequences of this age-related phenomenon include severe mental depression and decreased mental acuity. By inhibiting the elevated activity of MAG in older persons, Dr. MacFarlane said, GH3 decreases the rate of destruction of the brain neurohormones and allows depressed levels of these substances to return more toward normal. This, in turn, helps restore brain functioning. Although we know of other drugs as MAG inhibitors, their use has resulted in severe and sometimes fatal side effects, while adverse reactions to procaine, as previously noted, are almost non-existent.
Josef P. Hrachovec, a research associate at the Andrus Gerontology Center of the University of Southern California, reported at the same meeting about his investigation of the basic mechanism of procaine's activity in isolated tissues and in experimental animals. His findings show that GH3 inhibits MAG activity in the brain, liver, heart, and in blood platelets.
Interestingly enough, other MAG inhibitors have similar effects as the procaine preparations. Both are useful in the management of hypertension, angina pectoris, arthritis, depressive states and schizophrenic episodes. With MacFarlane's pharmacological rationale seemingly well established, it may now be possible to
find the common denominator for the many effects of procaine, KH3, H3 and gh3, which until now have been puzzling even to well-meaning investigators.
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H3 Book Index:: Chapters 1-29
