by Dr. Glenn Wilcox, D.O.M.
In medicine, two primary categories of hormones are prescribed for humans – bioidentical hormones and foreign/alien hormones. Although foreign/alien hormones are commonly used in conventional medicine, this is a very unwise practice. But why is this the norm?
In humans, hormones are substances produced by living cells, most often by an endocrine gland, that circulate in body fluids (such as blood) and produce specific regulatory functions (often a stimulatory effect) on the activity of cells usually remote from their point of origin. Hormones play an essential and dramatic role in health and vitality.
Examples of Human Bioidentical Hormones: Sex Hormones – Testosterone, Progesterone, Estrogens such as Estrone (E1), Estradiol (E2), and Estriol (E3); Thyroid Hormones – Triiodothyronine (T3), Thyroxine (T4), Thyroid Stimulating Hormone (TSH); Adrenal Hormones – Cortisol, Cortisone, Dehydroepiandrosterone (DHEA); Other Important Hormones – Melatonin, Oxytocin, Insulin.
What Are Human Bioidentical Hormones? These have the same biochemical composition as human hormones. They can be naturally derived or synthesized. Either way, the molecules are the same as those found in humans. Naturally derived bioidentical hormones usually come from the glands of animals. A good example is thyroid hormones, such as Nature-Throid or Armour Thyroid, that are derived from porcine (pig) thyroid glands. Porcine thyroid hormones are the same as human thyroid hormones. Synthesized bioidentical hormones are created in a laboratory from non-hormone precursor substances that are chemically manipulated until they are the same as human bioidentical hormones. Both synthesized and naturally derived human bioidentical hormones have the same effect in the human body.
What Are Foreign/Alien Hormones? Foreign/Alien hormones are hormones that have never naturally occurred in a human, and some of them have never existed in any animal or plant. Premarin is likely the best-known example. Premarin was introduced in 1941 and as the name hints, Premarin is derived from pregnant mare’s urine. It is a complex mix of more than 30 estrogen compounds from horses, most of which have never existed in humans. A more dramatic and questionable example is Progestin. Progestin is an analogue (similar but different) form of Progesterone. Progesterone is a human bioidentical hormone in men and women. Progestin is biochemically similar but not at all the same. Both Premarin and Progestin were frequently prescribed together for decades. For a time, Premarin was the top-selling prescription drug in the U.S. – until the Women’s Health Initiative (WHI).
The Women’s Health Initiative (WHI): Launched by the U.S. National Institutes of Health (NIH), it was one of the largest prevention studies involving women in the United States. In 2002 the results revealed that the use of the foreign/alien hormones Premarin and Progestin in post-menopausal women resulted in an increased risk for breast cancer, heart disease, stroke, blood clots, and urinary incontinence. Doctors significantly reduced their prescriptions for Premarin and Progestin. The related diseases declined, and post-menopausal women suffered. But why was there no study of bioidentical hormones and why didn’t doctors switch to bioidentical hormones rather than just stopping hormone therapy and allowing women to suffer?
Why Do Conventional Doctors Prescribe Alien Hormones? Generally, a naturally occurring substance may not be patented under U.S. patent law. A bioidentical hormone is a naturally occurring substance and therefore may not be patented. FDA approval of a new drug molecule costs from one to five BILLION dollars according to current estimates. The prime directive of a pharmaceutical company is to make money. There is no motivation for pharmaceutical company to seek extremely expensive FDA approval of a naturally occurring bioidentical hormone without first obtaining a patent on the hormone, so they can have a lock on sales for many years. It’s simply not a good business model for them. However, if they tweak that hormone molecule, as in the example of Progestin, the pharmaceutical company can get a patent. Simple! Unfortunately, the good business, “grope in the dark” strategy with a foreign/alien hormone resulted in increased disease.
It should be noted that sometimes pharmaceutical companies obtain FDA approval for a bioidentical hormone that includes a specific technology to administer it – a patch for example. In such a case it is not the hormone that is patented, it is the administration technology – the patch.
The “standard of care” in the conventional medical model in the U.S. focuses on the prescription of FDA approved drugs, either for their FDA approved use or for “off-label” use for a condition other than that for which it was officially approved. These FDA approved drugs are manufactured in large quantities in specific FDA approved doses and modes of administration and initially sold under a brand name, and then under the generic name after the patent expires. These are the drugs most commonly prescribed by conventional doctors. There are liability concerns whenever a doctor steps outside this “standard of care.”
The Science-Based (and Common Sense) Bottom Line! Humans have evolved their own human bioidentical hormones over the eons, and these very specific hormones are essential to health and vitality. Foreign/alien hormones have been recently developed based on a business model of healthcare rather than a medical model. This experimental foreign/alien hormone model has resulted in increased disease and we have been the lab rats. It’s time for a change…
Where Can I Get Safe, Effective Bioidentical Hormones? Fortunately, you have an option. Compounding pharmacies exist across the nation. They are licensed by the Pharmacy Board in each State. Compounding pharmacists are authorized to create prescription drugs from many substances including bioidentical hormones. These compounded drugs may be prescribed by a licensed medical professional who is authorized to prescribe. However, they may not be mass produced and must be prescribed by the authorized prescriber for only one of that prescriber’s patients at a time.*
* There is a recently created extension to the above information on compounding pharmacies called an FDA 503B Outsourcing Facility. While this would be useful for your doctor to know about, it is beyond the scope of this article for the consumer.
Compounded drugs from compounding pharmacies provide a valuable and essential medical solution. The compounded drugs may be compounded in any dose or form of administration, and without added ingredients. So, if a person needs a drug in a dose that is not available from pharmaceutical company, or in a form of administration not available, or even without the ingredients often added to a drug to which a patient has an allergy, it can be made and prescribed. Furthermore, other medical substances, such as bioidentical hormones, not available from big pharmaceutical companies, are available from compounding pharmacies. Compounded drugs are very essential to good medicine!
Safety: Let the buyer beware! In this case, that advice refers to both the prescribing doctor and the patient. Just as with doctors, some compounding pharmacists and pharmacies are more competent than others with respect to knowledge, protocols and facility. For many years I’ve worked closely with the only compounding pharmacy in New Mexico that has a Board of Pharmacy approved Clean Room that complies with both the State and Federal legal requirements defined in USP-NF Chapter 797 on pharmaceutical compounding of sterile preparations. That is Menaul Pharmacy. There are other competent compounding pharmacists and pharmacies in New Mexico. Make certain you get your compounded bioidentical hormones from a competent source.
For two decades I’ve prescribed appropriate bioidentical hormones for my patients based on leading edge lab tests and the clinical presentation of the person. I have observed that this powerful therapy is an essential component of Wise Medicine. Wise Medicine is holistic, based on proven tradition, and integrative with respect to incorporating the best of contemporary medicine. Wise Medicine is focused on optimizing energy and wellbeing, and always inclusive of the individual needs of the person when developing a solid, pragmatic, step by step strategy for recovering health and optimizing performance.
This article will continue in the next issue of Truly Alive. In it, I’ll reveal the advantages and disadvantages of the various forms of hormone testing. I’ll describe the history and evolution of bioidentical hormone therapy. And, I will dive deeper into the issues of bioidentical hormone safety. I will also explain the importance of understanding how the various bioidentical hormones work together, in a holistic symphony. That symphony is known as Health and Vitality! Come listen and we’ll enjoy together.