Germanium

Ever since I went to Japan, about 20 years ago I knew that "germanium" was a miracle cure for cancer and other maladies.

My wife was cured of Stage 3+ cancer of the esophagus using germanium, taheebo and a few other natual remedies. Her story is told in well over 1000 pages, mostly here.

There is no toxicity to organic germanium, despite what some evil-intentioned persons have claimed. I predicted such claims and even how they would be justified when I wrote MY book on germanium some 15+ years ago. Those predictions have come true.

Drug interests with their FDA puppets simply fed some people various substances, not organic germanium, watched them get sick from the known toxin, then found ways to fabricate the evidence that these persons took organic germanium.

Even today, in 2007, these false claims float about on the internet and are sent to me by otherwise bright people who think they have "discovered" some new data about one of my products for sale!!!

I am placing on this page some of those false claims -- in part to show that I am very well aware of them, and in part to show the true data.

First, here is the type of false claim that looks so convincing. it appears in a prestegious journal and sounds so scientific.

But no report is any better than the honest of the data on which it is based. For instance, many thousands of women went through a particularly barbaric form of treatment for breast cancer. I have the report HERE. When the truth was finally revealed, the researcher knowingly falsified his observed data and his conclusions were not disproven for many years -- many thousands of women had a very harmful treatment for their breast cancer. As usually happens, I found this record soon after it was first publicized on the media, but now, in 2007, many of those pages have quitely disappeared.

By Sarah Adler


 A study that influenced the use of a controversial treatment for women with advanced breast cancer has been retracted because it included bogus data. (PhotoDisc)

The guy who wrote the first below report probably didn't even know that he was dealing with false observations, but usually the truth does get revealed, as you will read further below.

source

GERMANIUM

Rough file:

 

Regul Toxicol Pharmacol 1997 Jun;25(3):211-9

Hazard assessment of germanium supplements.

Tao SH, Bolger PM

Center for Food Safety and Applied Nutrition, Food and Drug Administration, Washington, DC 20204, USA.

Germanium-containing dietary supplements became popular in the 1970s in Japan and later in other countries, as elixirs for certain diseases (e.g., cancer and AIDS). Germanium is not an essential element. Its acute toxicity is low. However, at least 31 reported human cases linked prolonged intake of germanium products with renal failure and even death. Signs of kidney dysfunction, kidney tubular degeneration, and germanium accumulation were observed. Other adverse effects were anemia, muscle weakness, and peripheral neuropathy. Recovery of renal function is slow and incomplete even long after germanium intake was stopped. The total dose of ingested germanium (as dioxide, carboxyethyl germanium sesquioxide, germanium-lactate-citrate, or unspecified forms) varied from 15 to over 300 g; the exposure duration varied from 2 to 36 months. In laboratory animals, elevated germanium in tissues and impaired kidney and liver function were observed in a life-time drinking water (5 ppm germanium) study. Other toxicities associated with ingested germanium products in human cases were also demonstrated in animal studies with germanium dioxide and sometimes other germanium compounds. Based on the evidence of persistent renal toxicity associated with germanium dioxide, the lack of conclusive findings of differential nephrotoxicity of organic germanium compounds, and the possibility of contamination of the organic germanium products with inorganic germanium, it is clear that germanium products present a potential human health hazard.

 

Title

Nephrotoxicity and neurotoxicity in humans from organogermanium compounds and germanium dioxide.

Author

Schauss AG

Address

Life Sciences Division, American Institute for Biosocial Research, Inc., Tacoma, WA 98401.

Source

Biol Trace Elem Res, 29(3):267-80 1991 Jun

Abstract

There is no known biological requirement for germanium (Ge), germanates, or any organogermanium compound. Ge deficiency has not been demonstrated in any animal. The estimated average dietary intake of Ge in humans is 1.5 mg/d. Ge is widely distributed in edible foods, all of which, with few exceptions, contain less than 5 ppm Ge, since higher levels are toxic to most plants. Ingestion of Ge compounds has been shown to produce toxic effects in experimental animals. In recent years inorganic germanium salts and novel organogermanium compounds, such as carboxyethyl germanium sesquioxide (Ge-132) and lactate-citrate-germanate (Ge lactate citrate) have been sold as "nutritional supplements in some countries for their purported immunomodulatory effects or as health-producing elixirs, resulting in intakes of Ge significantly exceeding the estimated average dietary intake. Since 1982, there have been 18 reported cases of acute renal dysfunction or failure, including two deaths, linked to oral intake of Ge elixirs containing germanium dioxide (GeO2) or Ge-132. In these cases, biopsies show vacuolar degeneration in renal tubular epithelial cells, without proteinuria or hematuria, in the absence of glomerular changes. Serum creatinine levels have been well above 400 mumol/L in such patients. In 17 of 18 cases, accumulated elemental Ge intakes reportedly ranged between 16 to 328 g over a 4-36 mo period, or between 100 to 2000 times the average estimated dietary intake for human. In surviving patients, renal function improved after discontinuation of Ge supplementation. However, in no case was recovery complete. One organogermanium compound, an azaspiran organogermanium compound, 2-aza-8-germanspiro[4,5] decane-2-propamine-8,8-diethyl-N,N-dimethyl dichloride (spirogermanium), has been found to cause both neurotoxicity and pulmonary toxicity in phase I and II studies examining its chemotherapeutic potential as an antitumor drug in the treatment of various malignancies. In cancer patients given the drug spirogermanium, 40% experienced marked, yet transient neurotoxicity. Two patients suffered from pulmonary toxicity. Results of phases I and II human cancer trials for spirogermanium have not been favorable, with the exception of moderate benefits for three types of malignancies. It is recommended that patients exposed to long-term (greater than 3 mo) Ge supplementation at levels well above the estimated daily intake be medically supervised and monitored for potential renal-, pulmonary- or neurotoxicity. Further study regarding the mechanism of Ge-induced nephrotoxicity in human is warranted.

_____________________________________________

I covered the next below, many years ago, on this web page.

On this web site, HERE, I have listed eleven different official studies on germanium.

________________________________________

Source

IA #54-07 - Revised 9/13/95, "GERMANIUM PRODUCTS"

****NOTE: Import Alert #62-02, "Germanium Products" dated 06/28/88, is
cancelled simultaneously with the issuance of this alert. The alert
is revised to remove the food additive charge in accordance with the
requirements of the Dietary Supplement, Health, and Education Act
(DSHEA) of 1994.****

TYPE OF ALERT: AUTOMATIC DETENTION

Note: This import alert contains guidance to FDA field personnel
only. It does not establish any requirements, or create any
rights or obligations on FDA or on regulated entities.

PRODUCT : Germanium products

PRODUCT CODE : 54YY-09
66V--99

PROBLEM : Poisonous and deleterious substance (PSNC) or
Unapproved new drug (DRND)

PAC : 21008
56008H

COUNTRY : All

MANUFACTURER
or SHIPPER : All

CHARGES : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain a poisonous
and deleterious substance which may render it injurious to
health [Adulteration, 402(a)(1)]."

or

"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be a new drug within
the meaning of Section 201(p) without an approved new drug
application [Unapproved new drug, Section 505(a)]."

RECOMMENDING
OFFICE : CFSAN: Division of Program and Enforcement Policy, Regulatory
Branch (HFS-456); Division of Field Program Planning and
Evaluation, Import Programs Branch (HFS-637).

REASON FOR
ALERT : Germanium is a nonessential trace element that has caused
nephrotoxicity (kidney injury) and death when used chronically
by humans, even at recommended levels of use. Germanium
containing products have been labeled for drug use (e.g., with
claims that they are intended for use in the diagnosis, cure,

IMPORT ALERT #54-07, 7/26/95 PAGE 2

mitigation, treatment, or prevention of diseases such as AIDS
or cancer), although there are no approved new drug
applications (NDAs) or current investigational new drug
applications (INDs) on file. Germanium containing products
also have been offered for entry as food products such as
dietary supplements.

GUIDANCE : Districts may detain all Germanium products offered for entry,
without physical examination, including unlabeled bulk
entries, except for semiconductor use as discussed below. If
the product claims to be useful in the diagnosis, cure,
mitigation, treatment, or prevention of disease, use the drug
charge; otherwise use the "poisonous and deleterious" charge.

There are legitimate uses for germanium in the semiconductor
industry. If an importer shows that the intended use of the
product is other than for human consumption, the entry should
be released with comment. If possible, appropriate follow up
should be made to assure the ultimate disposition is as
indicated by the importer.

Germanium may be offered for entry under a variety of names
including:

Germanium Sesquioxide
GE-132
GE-OXY-132
Vitamin "O"
Pro-Oxygen
Nutrigel 132
Immune Multiple
Germax

PRIORITIZATION
GUIDANCE : I

FOI : No purging required.

KEYWORDS : Germanium, Germax, Immune Multiple, Nutrigel 132, Pro-Oxygen,
Vitamin "O", GE-OXY-132, GE-132.

PREPARED BY: The Drugs, Devices, & Biologics SDWG, DIOP, HFC-170,
(301) 443-6553.

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FDA Home Page | Search FDA Site | A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

Office of Regulatory Affairs

_______________________________________________

I, Karl Loren, probably know more about the supposed "restrictions" on the import of germanium than any other person willing to tell the story.

I wrote a Book on germanium and predicted that the FDA would try to make it illegal to import germanium into the US. 

Shortly after my Book was published the FDA issued the "import alert" shown below.

In fact that "alert" did not make it illegal to import germanium, but simply allowed FDA officials to seize import shipments of germanium.  This alert did not require anyone to seize shipments and did not make it illegal for a person to import germanium.

If some FDA official did seize some imported germanium, it would then be up to the importer to show that the importation was not of the type described in the "alert."  The "alert," of course, describes "germanium" as being "poisonous" which is not true -- could be proven easily by feeding the true germanium to mice, the usual test for toxicity.

There is a very simple and standard test for toxicity of various substances -- it called the "LD50" test -- the "dose" that will kill 50% of a batch of test animals:

LD50, 50% Lethal Dose

Definition

• An LD50 value is the amount of a solid or liquid material that it takes to kill 50% of test animals (for example, mice or rats) in one dose.  (Source)

The amount of germanium dioxide (not the form we sell) that is toxic has been established:

LD/Lc50 values that are relevant for classification:
Germanium (IV) oxide (CAS# 1310-53-8), 100%
Oral: LD50: 5400 mg/kg (mus)  (source)

The above reference indicates that "germanium oxide" is lethal to a group of mice, to 50% of them, when fed to them at a rate of 5 grams per 1000 grams (one kg) of body weight.  On this same basis, a human who might weight 100 kilograms (220 pounds) would have to ingest 500 grams of germanium oxide for it to be toxic -- this would be about one full pound at one dose.  This very unlikely possibility applies to the "oxide" form of germanium.  Dr. Asai created a very different form, called "organic germanium" and there has never been any showing of any LD50 rate for this form.  It is not toxic in any dosage.

In 1995 Congress passed a new law restricting the FDA from the unproven types of allegations they were making.

Thus, in 1995 the earlier "alert" was canceled.

So, as of 1995 there has been no "import alert" affecting germanium.

There are, of course, several companies claiming to be selling germanium.  One even claims to be selling germanium which is manufactured within the United States.  I have claimed, in writing, that none of these sources has the authentic germanium which was the subject of patents in Japan.  None of those companies is willing to disclose the source, or country, of their supply of germanium.

I suspect that fake germanium is made in China and imported, but those who import this fake stuff are unwilling to put the "made in China" name on their product.

In any event, there is only one genuine source of germanium in the US -- that sold by Vibrant Life.

And, it is completely legal to import and sell.  Likewise, it is safe to take in any dosage.

Karl Loren

_______________________________________

Karl Loren's "Premium" site is at https://www.karllorenpremium.com This is a "members only" web site. You will need a password to gain access. You can learn about membership HERE.

THIS page takes a design motif from that web site for this special report on germanium, placing this page on the www.organicgermanium.net web site, where you are now.