Glandulars

Glandulars

"A study involving calf thymus extract, published in the New England Journal of Medicine, is perhaps the most notable among glandular studies because it is the first controlled U.S. study to test glandulars on humans. Seventeen patients suffering from rare but fatal lymphocytic abnormalities involving tumorous growths and organ lesions (Letterer-Siwe disease, Hand-Schüller-Christian disease and eosinophilic granuloma) were injected daily with thymus peptide extract. A control group of 20 people underwent chemotherapy, the normal treatment for these diseases. Ten of the 17 patients who responded to thymic extract experienced full remission after one year. Seven of the 17 showed either no change or clinical worsening after 28 days and therapy was discontinued. This remission rate was statistically comparable to previous study controls who were treated with chemotherapy." I might add - without the side-affects!


Glandular Growth Hormone vs Recombinant Human Growth Hormone - Have We Gone Mad?

Guest Editorials

Developments in science and the marketplace, along with recurrent questions about safety and efficacy have taken a toll on wellness products. This is for a good reason. People get hurt or die when safety and efficacy are disregarded. The FDA was founded in 1938 on the basis of safety issues with drugs. Although there may be problems between the FDA and Natural Product Industry, the FDA's issues around safety are critical when it comes to products containing glandulars. In January 2001, the Food and Drug Administration asked supplement makers to identify the source of bovine-derived products, including glandular extracts due to the publicity and concerns about transmissible forms of `mad cow' disease to humans, called 'variant Creutzfeldt-Jakob Disease (vCJD). Natural Product Industry officials consider the possibility of contracting the disease through supplements remote.[ 1] Officials worry that the faintest mention of the fatal neuro-immuno degenerative illness might cause consumers to swear off supplements. We in the industry, shouldn't be so cavalier about Natural Products being safe when it comes to vCJD. We need to protect consumers through safety, efficacy and truth in labeling of natural products. The horrifying lesson learned by the pharmaceutical companies in the 1980's, need not be a lesson the natural product industry has to learn in the 21st Century. The ramifications of irresponsibility could be devastating.

Before scientists learned how to make 'safe recombinant' hormones, animals were the source of many hormones, such as growth hormone and insulin. Growth hormone (GH) extracted from animals or humans, was from pituitary glands. Unfortunately, infectious pathogens, different from bacteria, fungi, parasites, viroids and/or viruses were contained in some of the pituitary or other neuro-hormonal, immune system tissues. The glandular extract of growth hormone was injected into children to treat their stunted growth, however it contained a pathogen, now called prions that resulted in neuro-immuno-degenerative disease. Their brains had holes punched in them, called spongiform encephalopathy, and plaques (clumps of protein) resulting in progressive dementia along with other dreadful slow vegetable-like state degeneration with inevitable death. Although death can ensue within 1 year, the incubation period is also documented at 5-20 years.

Prions are normal cellular glycoproteins that become abnormally altered in their structure after protein translation of the mRNA coding.[ 2, 3] The normal prion protein is protease-sensitive, however, the abnormal prion is protease insensitive and therefore cannot be broken down into smaller subunits. They actually stick together and form larger and larger syncytia. Contaminated prions, PrP[Sc] can be found throughout the body in blood forming organs such as the liver, bone marrow, spleen or any glands related to neuroendocrine communication such as pituitary, adrenals, kidneys.[ 4]
Cows became infected with a bovine form of this same prion phenomenon after eating contaminated feed. The cows exhibited bizarre behavior with neuro-immuno-degeneration as 'mad cow disease' or bovine spongiform encephalopathy (BSE) progressed. Human transmission of 'mad cow disease,' transmission from a cow to a human is now a reality, a variant of CJD. Thus, consuming bovine liver extract, pituitarium or any other hematopoietic or neuroendocrine glandular from any source runs a risk of ingesting a transmissible form of contaminated prions. Based on 22 cases identified from follow-up on the original 6,200 persons receiving contaminated growth hormone,[ 5] this risk is 0.35% which represents 985,000 people based on the statistics that 42% of US citizens use alternative medicine and there were an estimated 281.4 million people counted in the 1999-2000 census. That is a large enough risk for the Industry to be protective about!

The use of homeopathically prepared hormones in the form of animal glandulars dates back to the 1880's.[ 6, 7] However, now a 3X glandular, containing milligrams of liver extract, for example, runs a higher risk of transmitting contaminated prions than ever before. While, Dr. Samuel Hahnemann never heard of prions and CJD, it is a reality the Natural Product Industry and consumers must be educated about. Homeopathic and supplement manufacturers are inconsistent in their product quality, something we should all be concerned with. Results posted by ConsumerLab.com, a testing service founded by a physician and former FDA chemist, consistently shows labeling inaccuracies. Consumers and practitioners need to ask the hard questions about contents and proof of the labeling claims. More importantly, the source of the ingredients (where and what) must be addressed. Truth in labeling and advertising are essential to prevent fraud within the industry. One company, for example, ran ads this year st ating 'free of BSE-mad cow disease' when the truth is that BSE contamination cannot be detected by modern technology. The contaminated prion has no nucleic acids, is impossible to filter out, resistant to inactivation by chemical means, cannot be cultured to date and is unobservable by electron microscope.[ 8]

Recombinant DNA technology enables a safe manufacturing process of source material for hormones that eliminates the risk of prion contamination. No animal nor human material needs to be used. An overview of the highly detailed process[ 9] involves knowing DNA gene sequence coding for the protein you want to make. This is really the blueprint for the protein that will be produced safely. The blueprint is made using raw materials such as sugars, specialized proteins called pyrimidines or purines, and phosphates that are poured over a column and bound together in the code like fashion of the desired DNA. The DNA blueprint is then inserted into either bacteria or yeast which produce the proteins from the DNA blueprint attached to them. Next, all of the protein material is sent through a highly purifying filter that separates out the purified protein, growth factor or hormone. The FDA approved purifying process accords with good manufacturing procedures (GMP).

Consumers have become skeptical of natural remedies marketed for maladies ranging from sniffles to depression. The use of glandulars may be an Old World practice that requires some 21st century rethinking, considering the risk for prion contamination. Quality-control issues won't go away, neither should our first ethical standard -- do no harm.
Barbara Brewitt 206-284-3433

Email: DrBrewitt@biomedcomm.com

References

1. Gellene, D. Getting a dose of reality. Los Angeles Times, Feb 11, 2001
2. Prusiner, SB. Molecular biology of prion diseases. Science 252:1515-1522
3. Krakauer, DC, Zanotto, PM, Pagel, M. Prion's progress: pattern and rates of molecular evolution in relation to spongiform diseases. J. Mol. Evol. 1998, 47(2):133-145
4. Klein, MA et al. PrP expression in B lymphocytes is not required for prion neuroinvasion. Nat. Med. 1998; 4(12):1429-1433
5. http://www.niddk.nih.gov/health/endo/pubs/creutz/update.htm
6. Boericke W. Homeopathic Materia Medica, Philadelphia, Boericke and Tafel 1980
7. Clarke, JH Dictionary of Materia Medica, Saffron Walden England, Health Science Press, 1984
8. Leon-S, FE, Rodriguez, CI, Prada, DG Prions, infections and confusions in the "transmissible" spongiform encephalopathies. The other evidence-based science. III. Review, Invest. Clin. 2000, 41(3):189-210
9. Review Article -- Santis, G., Evans, TW Molecular biology for the critical care physician. Part II: where are we now? Crit. Care Med. 1999:27 (5):997-1003
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By Barbara Brewitt

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