Safety Of Organic
Germanium Products
The Exemplary Record Of Organic
Germanium's Safety
There is a long and drawn-out process of testing
required in order for a substance to be marketed as a drug. This involves
efficacy tests in animals, elaborate toxicity studies in animals, teratogenic
studies in animals, testing on human volunteers, then a tier of clinical
trials in humans. These requirements, in addition to providing the public
some assurance of safety, also contribute to the long lead time and
enormous expense of new product development.
All the Organic Germanium compounds discussed here
- Sanumgerman, Ge-132 and Spirogermanium - have been subjected to rigorous
testing, including all the above steps, and have been found to be virtually
non-toxic, except that Spirogermanium has been found to cause transient
nervous side-effects. At present, Spirogermanium is being developed
for use as a drug, while Sanumgerman and Ge-132 are available as nutritional
supplements. This may change in the future; it is possible that organic
Germanium may become classified as a prescription drug at higher doses.
Organic Germanium is also somewhat unusual, although
by no means unique, in that its creator, Dr. Asai tested the initially
synthesized product on himself, cured his arthritis, and distributed
it to others who also were therapeutically helped. Then extensive testing
was carried out, which confirmed the empirical and insightful determinations
that this substance was non-toxic. That organic Germanium is a naturally-occurring
substance and could be regarded as a food supplement, made this approach
feasible and probably accelerated the research and clinical findings
many-fold. If organic Germanium had been initially viewed as a new drug,
it probably would have had to undergo years of animal tests before being
given to humans for testing.
What Happens To Organic Germanium
In The Body
Organic Germanium compounds are rapidly absorbed
and eliminated from the body without undergoing metabolic alteration.
Studies have been performed which trace the route that organic Germanium
follows in its "trip" through the body (59,71). The studies
performed with the various compounds have yielded essentially similar
data with respect to absorption, distribution and elimination rates
from the body, and the following incorporates the data from all the
compounds.
Within one hour of administration, 50% of the compound
is in the gastrointestinal tract; after twelve hours, only 5% is there.
Organic Germanium is resorbed by the vena portae. One hour after administration,
50% is in the vena portae; after 8 hours, this figure rises to 85%,
and by twelve hours, it is quasi complexed. Serum plasma levels reach
a maximum two hours after administration; in eight hours, Germanium
is reduced by 80% of the maximum.
Organic Germanium, administered orally, has also
been shown to be absorbed by about 30%, distributed evenly throughout
the body, leaving almost no residual concentration after twelve hours.
It is excreted, unchanged metabolically, in the urine in twenty-four
hours. Germanium is ubiquitously distributed in all organs - there are
no specific taget organs, and no differences in distribution patterns
detected between sexes.
Organic Germanium is also eliminated at quite a
rapid, linear rate, of approximately 8% of the dose per hour, during
the first eight hours. It is completely eliminated after three days,
mainly via the kidneys (85%). Germanium is soluble in the interstitial
fluids, and is not protein-bound. Germanium does not accumulate in any
organ (see, however, below) - no Germanium can be found in animals one
week after their removal from treatment.
Animal Toxicity Studies
Animal toxicity studies measure doses and effects
of a substance administered and determine levels at which damage, or
indeed death occur. Sanumgerman and Ge-132 and were both found to be
totally nontoxic when administered orally, up to 3.4 g/kg and 10g/kg
respectively in mice and rats (2,86). This is a huge amount of organic
Germanium, which was not found to cause any abnormal effects which could
be detected.
Chronic toxicity studies were carried out in rats
for 6 months with both Ge-132 and Sanumgerman (2,86), with the animals
receiving varying doses of the respective organic Germanium compound.
At the termination of the study, an extensive range of parameters was
measured, to assess whether the administration of organic Germanium
over a protracted period caused any abnormalities. These parameters
included general condition, appearance, behaviour, motor activity, appetites,
body weight, biochemical assays of blood serum, hemoglobin, red cells,
leukocytes, platelets, weight of internal organs, macroscopic and microscopic
appearance of internal organs, respiration, blood pressure, intestinal
tonus and contractility. In totally independent studies, performed in
different parts of the world, with both these organic Germanium compounds,
no abnormalities in any of these parameters were found.
Human Toxicity Studies
In human clinical trials with healthy volunteers,
as well as patients who have participated in all the studies described
throughout this book, the toxicity of the particular organic Germanium
compound was assessed (70). One of the outstanding features of organic
Germanium is its virtual nontoxicity and its ability to be tolerated,
in contrast to most highly toxic drugs. Even Spirogermanium, which seemed
to generate mainly neurological symptoms, was remarked to be well tolerated.
However, it is difficult to directly compare Spirogermanium to Ge-132
and Sanumgerman, because it has mainly been administered intravenously
in human patients.
In the large number of case histories and clinical
trials reported, there are very few reports of any symptomology developing
as a result of oral organic Germanium administration.
Taken orally, organic Germanium is highly safe.
Teratogenic Studies
Teratogenic studies assess any damage to developing
foetuses that is cause by administration of a substance to pregnant
mothers. Ge-132 has been assessed for teratogencity with mice, rats
and rabbits; Sanumgerman (an older formulation) with rats. For both
these organic Germanium compounds, there were no noted abnormalities
to the pregant females. With some doses of both these compounds, there
were some differences in the weight of fetuses and the ratio of absorbed
fetuses, and skeletal abnormalities were observed (2,22). Skeletal malformations
also occurred in the control group.
It is difficult to accurately extrapolate between
animals and humans. In teratogenic studies, animals are often given
rather high doses of a substance, higher than a human would probably
ingest. However, despite Dr. Asai's assertions of the benefits of taking
organic Germanium during pregnancy, the demonstration of even slight
teratogenic activity in animals should be borne in mind when considering
taking any substance during pregnancy.
Toxicity Of Contaminated Organic
Germanium Compounds
There is a single report in the literature of a
woman who had been taking a Germanium compound over a protracted period,
who died of renal failure (75). This woman had been taking 600 mg per
day of a Germanium compound for over eighteen months as an elixir. Following
her death, analysis of the compound revealed mainly Germanium dioxide
(GeO2), with some organic Germanium compound. An autopsy revealed gross
cellular abnormalities of kidney tissue and an increased accumulation
of Germanium in several organs. It was not possible to determine whether
the Germanium compound had caused renal failure, or whether renal failure
had caused the accumulation of the Germanium, since Ge is eliminated
mainly by the kidneys.
Study of the older toxicity literature, spanning
the 1920's to the 1950's which investigated the toxicity of mainly inorganic
Germanium (42,84,90-91,114), reveals that, properly buffered and administered
in sub-lethal doses, inorganic Germanium is not always damaging; however,
in some cases, shock and death occurred to animals administered inorganic
Germanium. This Japanese woman had been taking a compound composed mainly
of inorganic Germanium, and had suddenly taken ill and died. Although
this is the only reported case ever of the accumulation of Germanium,
it should not be dismissed necessarily as coincidence; it should be
borne in mind that inorganic forms of Germanium may be toxic in high
doses.
Organic Germanium Is Safe
The rigorous tests described above demonstrate the
safety of taking even very large doses of organic Germanium. Doses of
more than 10g/kg body weight produced no damaging effects in rats. A
very large therapeutic dose, administered for cancer patients may be
1g per day, obviously much less than that given the rat.
Many of the most common substances we ingest, including aspirin, and
even some supplements, such as selenium, have toxic properties. It is
said that if many of our older medications were forced to undergo the
rigours of present-day testing, they would fail. In light of this, apart
from the suggested caution during pregnancy, organic Germanium, even
taken at high dosages, is certainly safe.
