Endocrinologist Groups Reject FDA's Testosterone Therapy Position

Two endocrinologist societies have issued a joint position statement recommending that the decision to prescribe testosterone replacement therapy (TRT) to hypogonadal men should be guided by signs and symptoms and testosterone levels rather than the underlying cause, as recommended by the FDA in response to concerns about cardiovascular risks associated with TRT. In the position statement, the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) say the evidence for increased cardiovascular risks associated with testosterone use is weak. Two retrospective studies raised concern that testosterone therapy increases cardiovascular risk, but these studies have major flaws “precluding meaningful conclusions to be drawn,” according to the statement.

The statement, which was published recently in Endocrine Practice (2015;21:1066-1073), was prepared by Neil Goodman, MD, of the University of Miami Miller School of Medicine, and other members of the AACE Reproductive Endocrinology Scientific Committee.

“Epidemiologic studies strongly support the association of low testosterone concentrations and hypogonadism with cardiovascular events and all-cause mortality, especially in elderly men,” the position statement reads. “However, low testosterone could be a marker of illness and not a causal factor.”

The statement also pointed out that TRT “favorably changes many cardiovascular risk factors. It decreases fat mass, increases muscle mass, decreases insulin resistance and can reverse metabolic syndrome in some men.”

In March, the FDA issued a statement that read, “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.” According to the FDA, testosterone “should not be used to relieve symptoms in men who have low testosterone for no reasons other than aging.”

The AACE/ACE statement recommends that TRT be considered “for symptomatic men who have unequivocally low total and/or free testosterone levels that are assayed on at least 2 samples drawn before 10 am.” All men being considered for TRT must undergo a thorough diagnostic work-up.

“Since the risk/benefit ratio of TRT is not well established in aging-associated hypogonadism, we advise the practicing clinician to be extra cautious in the symptomatic elderly with demonstrably low testosterone levels prior to embarking on replacement therapy and to avoid treatment of the frail elderly altogether.”

Sermorelin Therapy

Sermorelin is a synthetic drug which is derived from GH-RH, which is also known as Growth Hormone-Releasing Hormone. GH-RH is the hormone responsible for the production of Human Growth Hormone, commonly referred to as HGH. GH-RH is secreted by the hypothalamus and functions as a chemical messenger which sends the signal to the pituitary to secrete more Human Growth Hormone to be delivered throughout the body. Sermorelin is not naturally produced by the human body, but it is functionally identical to Growth-Hormone Releasing Hormone produced by the human body. Sermorelin contains the same initial 44 proteins that are present in GH-RH, and scientists and researchers have discovered that this truncated version of Growth Hormone-Releasing Hormone is the shortest known derivative that produces an identical effect upon the body as GH-RH, which is to enhance pituitary secretion of HGH.

HGH and Human Development In our preteen and early teenage years, Human Growth Hormone is primarily responsible for the increase in growth rate associated with puberty. Children that suffer from a deficiency in Growth Hormone-Releasing Hormone do not produce sufficient levels of Human Growth Hormone and therefore do not grow at the same rate as their peers. Human beings complete the process of normal growth and reach their final adult height after the epiphyseal plates of their long bones close at the end of puberty.

After this point, the role of Human Growth Hormone changes, yet the role of GH-RH remains the same. After puberty, the body needs to produce sufficient levels of Growth Hormone-Releasing Hormone that allow the body to secrete the HGH that it needs to sustain itself at peak condition, allowing us to enjoy maximum vitality and health. GH-RH allows the body to function optimally as it was meant to function.

With Age, GH-RH Levels Decline Unfortunately, production of Growth Hormone-Releasing Hormone by the pituitary drops as we age, and this reduction in endogenous production of GH-RH is directly correlated with reduced release of Human Growth Hormone, which inevitably leads to a rapidly sped up aging process. At age twenty, the human body produces an optimal level of adult Human Growth Hormone-around five hundred micrograms each day. By the time we reach our late twenties to early thirties, the levels of endogenous Human Growth Hormone that we produce decreases at a seemingly marginal rate of one to two percent each year. Over time, however, this constant decline accumulates, leaving our bodies grossly deficient in Human Growth Hormone. By the time we reach the age of eighty, the human body only secretes around sixty micrograms of Human Growth Hormone daily-often even less! In otherwise healthy adults, an HGH level of around two hundred micrograms is considered low.

The effects of Human Growth Hormone Deficiency begin to become more pronounced as we enter our late thirties and early forties. At this point, our deficiency in Human Growth Hormone begins to greatly under-perform and our bodies start to age more rapidly. Rapid aging is not inevitable, however. And Sermorelin Therapy is a fantastic means by which to alleviate the effects of age in away that allows us to grow old in a healthy way that does not take from us our vitality.

HGH Therapy vs. Sermorelin Therapy Human Growth Hormone Replacement Therapy is effective at treating Human Growth Hormone Deficiency, but it may not be the most efficient way to restore optimal hormone production. It may only be covering up an underlying problem.

HGH Hormone Replacement Therapy simply replaces endogenous Human Growth Hormone with HGH from an outside source. Sermorelin works by increasing the level of HGH naturally secreted by the body, which leads to more natural release of the hormone throughout the body when and where it is needed. Sermorelin treats underlying neuroendocrine failure which leads a large number of patients who suffer from Human Growth Hormone Deficiency while having a perfectly healthy pituitary function.

For these patients, Sermorelin Hormone Replacement Therapy produces more natural physiological function while also being safer and having a significantly lower risk for unwanted side-effects than simply treating the symptoms of Human Growth Hormone Deficiency rather than the root cause. In addition to this, Sermorelin Hormone Replacement Therapy is not restricted in the same manner as HGH Hormone Replacement Therapy for use in patients that suffer from HGH Deficiency.

Benefits of Sermorelin: Below are just a few of the Benefits of Sermorelin Therapy:

• Sermorelin enhances the Pituitary Gland's natural ability to produce endogenous Human Growth Hormone, leading to a more natural Hormone Profile
• Sermorelin optimizes the human body, increasing physical and mental performance
• Sermorelin strengthens immune health
• Sermorelin boosts the liver's production of Insulin-Like Growth Factor One
• Sermorelin helps patients sleep longer, deeper, and better

Restoring Endocrine Function with Sermorelin As a result of generations of Anti-Aging and longevity science, we realize today that Hormonal Balance is the key to preserving the optimal function of the many organ systems that make up the human body. When hormones are not released in a sufficient amounts, or when certain hormones are produced in excess, the body can suffer greatly as a result. This is more apparent regarding HGH and its correlated secretagogue, Growth Hormone-Releasing Hormone, than with any other hormones produced by the body. A myriad of issues that are correlated with the process of aging are intricately connected to insufficient levels of GH-RH and HGH in the brain and in the blood stream. Though there are a multitude of reasons why the body produces less Human Growth Hormone as we age, among the most prominent and easily resolved issues is GH-RH Deficiency, which can easily and safely be restored with Sermorelin Therapy.

What Makes Sermorelin Preferable to HGH Hormone Replacement Therapy? The effects of HGH injections are not well-regulated by the body. If a person administers too much Human Growth Hormone, the body has no way of negating the effects of the flood of HGH entering the body. The pituitary gland may depress over time and release less endogenous HGH to compensate, but the body will still over-react to excess levels of HGH that occur as a result over overdose or abuse. This reduced level of endogenous HGH production is actually a bad thing, because once an individual suspends HGH injections, the body will not be able to produce the same levels of Human Growth Hormone as it once did until it slowly increases its natural production again over a significant period of time.

HGH and Negative Feedback On the other hand, the effects of excess synthetic GH-RH are regulated in two ways by the body. One way is by means of negative feedback. Via negative feedback, the pituitary gland sends a message to the hypothalamus telling it that it no longer needs to produce more Human Growth Hormone. The second manner by which Human Growth Hormone production is regulated when using Sermorelin is by somatostatins.

Somatostatin HGH Inhibitor Somatostatins are hormones which prevent the pituitary from taking up excess levels of Growth-Hormone Releasing hormone, thereby preventing the Pituitary Gland from producing excess levels of HGH. By means of these binary inhibitory factors, the risks associated with Human Growth Hormone are minimized, and when Sermorelin is used correctly with a physician's prescription, the side-effects of HGH overdose will likely be completely eliminated.

Sermorelin is Safer and More Natural than HGH Hormone Replacement Therapy Patients who use HGH Hormone Replacement Therapy are at a slightly enhanced risk of joint disorders such as Arthritis and Carpal Tunnel Syndrome. Older patients may find this reason enough to forgo HGH Therapy for Sermorelin Therapy. In addition to this, patients who undergo Human Growth Hormone Replacement Therapy sometimes suffer from temporary blood sugar fluctuations as a result of surging or quickly dissipating IGF-1 levels. These effects are not present when using Sermorelin Therapy.

Another way that Sermorelin Therapy is superior to HGH Hormone Replacement Therapy in many patients is that Sermorelin encourages a more natural production of Human Growth Hormone by the body. Sermorelin Therapy leads to episodic production of Human Growth Hormone, which is the manner by which the human body naturally secretes Human Growth Hormone. HGH is secreted by the pituitary gland in pulses which quickly dissipate throughout the body, where it is eventually converted into IGF-1 by the liver.

One patient group that may prefer Human Growth Hormone Replacement Therapy are patients that are interested in faster results at the expense of taking a bit of risk. Sermorelin Therapy takes a bit longer to produce physiological changes, but there is only a minimal chance of side effects as a result of therapy.

When undergoing Human Growth Hormone HRT, HGH is released into the body from the injection in a square wave. This means that the body is initially exposed to a high level of HGH which slowly dissipates between administrations, rather than in the natural spurts of production that the body is accustomed to. By preserving normal physiological production of Human Growth Hormone, a phenomenon known as tachphylaxis is prevented. Tachphylaxis is the phenomenon by which the body responds to an excess or constant level of a particular medicine or hormone by developing a sudden and increased resistance to that medicine or hormone, reducing its effect on the body. Some physicians who recommend Human Growth Hormone Therapy will accompany it with a certain level of Sermorelin Therapy as a means to prevent the pituitary gland from reducing its activity in the wake of increased exogenous Human Growth Hormone.

It is important to supplement the natural hormone production of the body in as natural of a manner as possible so that we may preserve the natural neuroendocrine axis that HGH is an important component of. As we age this axis becomes more and more fragile and prone to degradation and insufficiency.

Why Estrogen Balance is Critical to Aging Men

By William Faloon

We tested estrogen based on published data indicating that when estrogen levels are unbalanced, the risk of degenerative disease in aging men skyrockets.1-7 Of concern to us 14 years ago were reports showing that excess estrogen contributes to the development of atherosclerosis.  Human clinical studies conducted more than a decade later confirmed our suspicions. Men with even slightly elevated estrogen levels doubled their risk of stroke and had far higher incidences ofcoronary artery disease.10-12 Our early observations also revealed that men presenting with benign prostate enlargement or prostate cancer had higherblood estrogen levels (and often low free testosterone blood levels). Insufficient estrogen, on the other hand, predisposes men to osteoporosis and bone fracture. The fact that 99% of men today have no idea what their blood estrogen levels are helps explain the epidemic of age-related disease that is bankrupting this nation’s medical system. New Study Published in the Journal of the American Medical Association Conventional doctors tend to ignore hard science until it appears in their own medical journals. A study published in the Journal of the American Medical Association (JAMA) measured blood estradiol (a dominant estrogen) in 501 men with chronic heart failure. Compared to men in thebalanced estrogen quintile, men in the lowest estradiol quintile were 317% more likely to die during a 3-year follow-up, while men in the highest estradiol quintile were 133% more likely to die.24 The men in the balanced quintile—with the fewest deaths—had serum estradiol levels between 21.80 and 30.11 pg/mL. This is virtually the ideal range that Life Extension® has long recommended male members strive for. The men in the highest quintile who suffered 133% increased death rates had serum estradiol levels of 37.40 pg/mL or above. The lowest estradiol group that suffered a 317% increased death rate had serum estradiol levels under 12.90 pg/mL. The dramatic increase in mortality in men with unbalanced estrogen (i.e., estradiol levels either too high or too low) is nothing short of astounding. It uncovers a gaping hole in conventional cardiology practice that is easily correctable. This study revealing the lethal dangers of estrogen imbalance was published in conventional medicine’s Bastille of knowledge—the Journal of the American Medical Association. Low Estradiol and Testosterone Predict Mortality in Aging Men Sales of testosterone replacement drugs have surged more than 20-fold in response to studies linking low testosterone to a host of common maladies. In a recent study of 3,014 men aged 69-80 years, serum levels of testosterone and estradiol were measured during a mean follow-up of 4.5 years. Men with low testosterone had 65% greater all-cause mortality, while men with low estradiol suffered 54% more deaths.25 Those men low in estradiol and testosterone were almost twice as likely to die (a 96% increase in mortality) compared to men in the optimal ranges.25 This large study of aged men corroborates prior published reports linking imbalances of testosterone and/or estradiol with greater incidences of degenerative disease and death.26-36 How Do Men Naturally Make Estrogen? Women synthesize most of their estrogen in their ovaries and other reproductive tissues. Since men lack this female anatomy, they need to produce estrogen through a process involving an enzyme called aromatase that transforms testosterone into estradiol. Aging men sometimes have too much aromatase activity, which causes their testosterone to convert to excess estradiol. This results in depletionof vital testosterone while spiking estradiol to unsafe ranges. Some men lack aromatase and suffer an estrogen deficit. Other men produce so little endogenous testosterone that there is not enough to convert into estrogen, which causes low levels of both free testosteroneand estradiol. Fortunately, no matter what the underlying cause, aging men can easily achieve optimal free testosterone and estradiol serum levels. Free testosterone is the unbound form that is biologically available to cell receptor sites throughout the body. Measuring free testosterone blood levels is the most accurate way of assessing testosterone status in aging men. How Aging Men Can Control Their Estrogen Levels An epidemic problem in aging male members is insufficient free testosterone, i.e., less than 15-20 pg/mL of serum. When accompanied by excess estradiol (over 30 pg/mL of serum), this can signal excess aromatase enzyme activity. Excess aromatase robs men of their testosterone while exposing them to higher than desirableestradiol.37 Aromatase can be suppressed with absorbable forms of chrysin (a plant flavonoid) and/orlignans such as those extracted from the Norway spruce tree (HMRlignan™).38-42 If these nutrients fail to reduce estradiol adequately, then we suggest that men ask their doctor to prescribe an aromatase-inhibiting drug like Arimidex® in the very low dose of 0.5 mg twice a week. When aromatase is properly suppressed, estradiol levels are reduced to safe ranges, while free testosterone often increases, since less testosterone is being aromatized into estradiol.