Science Fiction or Science Facts?
Dispelling the Growth Hormone Absorption Myth - Recent Research Reviewed
By Roy Dittman, OMD

In December of 1996, Ronald Klatz, MD - author of Grow Young With HGH said to me, "Dr. Dittman, the only thing you really have to do with [Biotropin] is prove that growth hormone can be absorbed. That is the only study you need. If you can do that, the world is your oyster, Roy" (actually, I think the world is looking more and more like a pearl these days Ronald). Dr. Klatz was referring to a micro-dilution growth hormone (GH) supplement formulation that I co-developed back in 1996, now called Biotropin.

Initial research to discover a GH delivery system was initiated at a major US university. An all-natural delivery agent with unique bio-chemical properties was thought to be a possible answer. Over the next three years, in-vivo research would confirm the hypothesis. In fact, not only was the delivery agent able to deliver large molecular weight proteins without the use of injections, it seemed to exhibit unique sustained release properties and kidney regenerative properties! Growth hormone was the ideal match at 191 amino acids - it is among the largest and most complex protein hormones in our bodies. Shortly after the initial discovery, patents were filed on this unique technology.

The invention of this delivery system, a unique macro-molecular complex (MMC-2000), is one of the greatest breakthroughs in bio-technology. For the first time in history, nutrients and pharmaceutical agents too large to be absorbed without the use of injections are finally capable of being delivered not only more efficiently and conveniently, but through the mouth!

Applying MMC-2000 to growth hormone has lead to the development of the most powerful dietary supplement known to date. Growth hormone is the body's master hormone, responsible for the regulation of most of the body's critical hormones, such as insulin, IGF-1 (insulin-like growth hormone-1), melatonin, estrogen, and testosterone.

The human tragedy is that growth hormone levels drop off dramatically in middle-age, contributing to the phenomenon we call aging. With growth hormone levels compromised, the following critical biological systems are compromised as well: (1) protein synthesis, (2) immune system regulation, (3) glucose regulation, and (4) fat metabolism. Gentle and effective supplementation of growth hormone may be able to assist in undoing the negative health implications of low growth hormone levels.

Once I understood the power of GH as an anti-aging supplement, both myself and the researchers responsible for the discovery of the MMC were left with the challenging task of scientifically demonstrating that we could achieve absorption of GH without the use of injections.

Thus far, the scientific experiments reviewed in this article are the only known studies that verify the actual absorption of GH across mucous membranes using the MMC delivery system. For the first time in human history, large molecular weight proteins such as GH can be delivered through the mouth, nose, trachea, or lung without causing cell membrane damage. The scientists that developed the MMC were the first known scientists in the world to succeed in accomplishing this amazing bio-tech advancement. It is not far-fetched to hypothesize that the implications of such a discovery, especially when applied to the latest genetic research, may one day be considered equal to the significance of recombinant technology, sequencing of peptides and nucleic acids, and gene splicing. This hypothesis is further supported when one considers the recent failure of retroviruses to effectively and safely deliver genetic material into a cell without causing cell damage. After all, even the best drugs and nutrients are useless without safe and effective delivery into the body.

The Big Scam At the Big Top of the Dietary Supplement One Trick Dog and Pony Show

Since the first introduction of an oral GH supplement (micro-dilution) and since the original patents were filed on the MMC in 1996, over 150 new GH products have flooded the market with amazing claims trying to cash in on the lucrative anti-aging market baby boomers have demanded.

Although only about eight of these products actually claim to contain GH or imply they can deliver GH (the rest are just precursors or secretagogues of GH and are therefore completely distinct from oral GH), these eight products have successfully confused consumers, keeping hidden the simple fact that any doctor will confirm - GH is too large to be absorbed through the mouth without a proven delivery method, which if discovered (it has been), would rock the bio-tech industry.

These GH products claim that even if GH is not absorbed, it is still effective. Moreover, some claim to have uncovered the secret formula for delivery. I find this hard to believe, since such a discovery would at the very least warrant the filing of patents to protect their discovery. It is humorous to note that following the discovery of MMC-2000, my home and the home of one of my business associates was broken into; confidential files were stolen; and a number of companies admittedly were in the process of trying to reverse engineer MMC-2000. Thus far, all attempts to counterfeit Biotropin have failed.

When asked to show scientific evidence of absorption, many other oral GH companies hand you a piece of paper showing IGF-1 level increases. There is just one problem: IGF-1 is not GH. Yes, they are related, but one can stimulate IGF-1 by working out, eating protein, etc.

Growth Hormone / IGF-1 physiology is incredibly complex, especially when growth hormone is given in a micro-dilution form and expected to dramatically enhance IGF-1 levels. In fact, human clinical research on growth hormone absorption using Biotropin (a micro-dilution growth hormone supplement that uses patent pending MMC technology) confirmed that IGF-1 levels normally fluctuate throughout the day by as much as 30% - bringing IGF-1 into question as a sole marker for GH absorption.

If that were not deceptive or misleading enough, many companies site studies done on injectable GH to imply: (1) that the GH in their product is bio-available (primed for absorption), and (2) that their product will perform for you in the same way. It is appropriate to refer to injectable GH research with the intent to inform consumers about the functions of GH in the body and the potential benefits as long as the company draws a distinction between injectable GH and their micro-dilution GH product, precursor, and/or secretagogue.

So, how did the market get confused? Why have usually rational, mature baby boomers swallowed these phony products hook, line, and sinker? Number one - most of them want to believe there is some secret Fountain of Youth - they'll do almost anything if it promises to make them look younger. When consumers read books on GH, they are seduced by the promises of GH. After all, GH is the most exciting rejuvenating substance ever discovered. Number two - some of these scams are cleverly deceitful and sophisticated. Some are so sophisticated that it would take a well-trained scientific researcher to see through them.

A medical researcher well trained in the physiology of IGF-1 and GH in human subjects would know the following:

  • 1. IGF-1 and GH are not interchangeable hormones. IGF-1 is a metabolic hormone secreted by the liver, and GH is produced by the anterior pituitary gland. IGF-1 is almost entirely metabolic in its function, whereas GH is much more adaptable and functions in many other domains such as immune system regulation.

  • 2. IGF-1 and GH work in a feedback system - initially, IGF-1 levels can increase in response to GH. However, at a certain critical point when IGF-1 levels increase to high levels, GH levels actually begin to decrease.

  • 3. The reason why IGF-1 has been used as a standard for GH testing is because it is the most reliable metabolic pathway related to GH physiology. It is the most convenient and inexpensive way for doctors to get an idea of where GH status is.

  • 4. IGF-1 levels in the blood were used as a marker to indicate GH status in studies where very large amounts of injectable GH were used. The amount of GH used in these studies was anywhere from 330,000 ng / day to 4,000,000 ng / day. GH at these concentrations has the ability to force IGF-1 level increases that exceed normal daily IGF-1 level fluctuations. However, in a micro-dilution preparation, the most GH allowed as a dietary supplement is 2000 ng/ml or 2000 ng per day. In most cases, GH at this level is not enough to detectably stimulate a dramatic increase in IGF-1 levels. Using IGF-1 as a sole market for GH absorption in micro-dilution form is not only inappropriate, it is scientifically nave.

  • 5. Another misconception which is prevalent with both consumers and doctors is that growth hormone always increases IGF-1 levels. They use IGF-1 as a litmus test to verify the validity of a micro-dilution GH product. Doctors feel that without verifiable IGF-1 increases, a micro-dilution GH product is worthless. This could not be further from the truth. GH is responsible for the regulation of numerous important biological functions more delicate than IGF-1. In fact, research done on injectable GH at high concentrations consistently shows that in most cases, approximately 60% of the subjects would have increases in their IGF-1 levels, 20% would exhibit IGF-1 decreases, and about 20% would stay the same. Does that mean that GH is not being absorbed when injected into those subjects whose IGF-1 levels remained unchanged or decreased? Of course not! The reason why this occurs is quite obvious to scientists studying human physiology. It is because GH regulates and balances not only IGF-1, but also every other hormone in the body - either directly or indirectly. That is why GH is called the master hormone and the pituitary gland - the master gland.

  • 6. A valid question for scientists to answer is: "Is micro-dilution GH useful and effective?" This question will be answered in great detail in future articles. (For the record, I have concluded that it is not only the most intelligent way to supplement with GH, it is effective.)
When assessing a GH supplement, carefully consider what the company presents about GH absorption.

The following is a summary of critical facts about Biotropin - the only micro-dilution GH supplement that has been shown to contain bio-available GH.

  • 1. Verifiable university research on absorption of GH and insulin.

  • 2. First filed patent on absorption of large protein hormones such as GH and insulin.

  • 3. Manufactured in an ISO 9001 pharmaceutical facility.

  • 4. Human clinical studies on GH absorption.

  • 5. Delivery system shown to have kidney restorative properties (completed in-vivo research).

  • 7. Ongoing strategic research agreement with a major US university to study advanced. delivery systems for dietary supplements and pharmaceutical agents.

  • 8. GH stability research to preserve the quadruple-helical structure of the GH molecule.

  • 9. Established (1) proprietary methodologies for preserving GH at room temperature, (2) preventing oxidation of GH, and (3) preventing the deamidation of GH.

  • 10. University developed proprietary verifiable methods for determining GH content and concentration in a micro-dilution preparation.

  • 11. The MMC delivery system does not cause cell membrane damage. Instead, it works by gently absorbing GH into the cellular receptor site.

  • 12. Delivery system research presented at a prestigious scientific conference and accepted for scientific publication.

  • 13. First oral GH product on the market, documented at a conference lecture in January 1997.

Research Review

Growth Hormone Absorption

As science and technology took off in the 1990's, researchers began to look for more convenient ways to deliver drugs and dietary supplements - giving birth to a wealth of delivery systems designed to make absorption of nutrients and drugs more efficient, less painful, and more convenient. While vitamins began to be sprayed instead of swallowed and birth control began to be applied to the skin rather than in the mouth, science remained baffled at how to steer away from the needle to deliver such large substances as insulin, growth hormone, vitamin B-12, and IGF-1 (insulin-like growth factor-1, a metabolic hormone). Despite the hundreds of millions of dollars spent to develop a delivery solution, pharmaceutical companies and researchers were left without a viable, cost-effective option to injections - that is until the development of the MMC.

Any scientist or medical researcher would agree - the results of the GH / MMC experiment reviewed below clearly demonstrates absorption of GH. The absorption experiment is being followed on its heels by numerous other experiments to verify absorption in other ways (to be reviewed in future articles).

Background

A series of animal experiments were conducted at the College of Pharmacy at a major US university to determine whether growth hormone could be absorbed without the use of injections. These experiments followed on the heels of similar animal experiments conducted at the same university on the non-injectable absorption of insulin, another large molecular weight hormone.

Researchers had conclusively determined that by binding a unique macro-molecular complex (MMC) to insulin, insulin could be absorbed without the use of injections through various routes - the trachea and the nose. Confident that the same delivery system could be used to deliver GH, a substantially larger molecule, the same in-vivo protocol was used to test its efficacy.

Two experiments were conducted on GH absorption. Each was duplicated over six times to ensure accuracy.

Experiment #1: Establishment of GH-Specific Glucose Reduction Response Experiment #1 served as a marker for Experiment #2. In Experiment #1, growth hormone was injected into the muscle of a rabbit, similar to the way GH is administered to humans.

Graph #1 shows what happens when the rabbit was injected with two forms of growth hormone - human growth hormone and porcine (pig) growth hormone. In both cases, the rabbit's blood glucose was reduced dramatically upon introduction of growth hormone - a predictable response, evidence of growth hormone's glucose response pattern. This experiment was repeated six times to ensure accuracy of the findings. This glucose response curve served as a comparison for the actual GH absorption experiment. Show Graph #1 Here

Experiment #2: The Trans-Mucosal Absorption of Growth Hormone In Experiment #2, the trans-mucosal (across the mucous membranes) absorption of GH was assessed using the MMC. In this experiment, GH was bound to the MMC. Here, the rabbits were given GH bound to the MMC in liquid form, which was dripped into the opening of their trachea - a non-conventional route, which, without the presence of an advanced delivery system, would normally result in little to no absorption. However, when complexed to the MMC, the GH was clearly absorbed, showing a similar GH-specific glucose reduction response as seen in the graph for Experiment #1 above.

Show Graph #2 here.

Summary of Research Findings

1. Pharmaceutical scientists and medical researchers asked the question, "How do you interpret these research findings?", responded by saying that the findings conclusively show evidence of GH absorption in the presence of the MMC.

2. When comparing Experiment #1 to Experiment #2, where the GH / MMC is used, there is both a slower lowering of glucose levels and a sustained reduction in glucose levels.

3. In Experiment #1, where GH is injected into the rabbit, there is a rapid drop from 120 to 78 over the course of approximately 1-hour. In Experiment #2, it took over three hours to achieve the same glucose reduction response.

4. The relevance of points #2 and #3 above is that the administration of GH / MMC was the gentler and overall superior method for administering GH. When glucose levels drop off dramatically over a short period of time, a great deal of physiological stress is placed on the individual.

In conclusion, the move to discover a successful delivery system for GH took over six years of pharmacological research and ingenuity. The bonding of GH to MMC-2000 to produce Biotropin takes over six hours to process. Dietary supplement companies purporting to have a viable delivery system for GH fail to have the adequate science to support their claims. I would caution the use of these supplements, as they are costly, and probably ineffective at delivering GH. Results achieved on other oral spray GH products may be from other metabolic stimulators other than GH present in the products.



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