Bioidentical Hormone Replacement Therapy

A bioidentical steroid hormone is not human in origin but is identical in organic structure and function to human hormones.  Bioidentical hormones are derived from a plant oil called diosgenin, which is very similar in chemical structure to our endogenous precursor steroid hormone, cholesterol.  Diosgenin is extracted from soybeans and wild yams. These crops can abundantly and inexpensively produce the oil, which is also available in several thousand other plants worldwide.  Diosgenin is then chemically altered in a lab to exactly match our human bioidentical steroids.  Any allergenicity to these plants is also removed during the conversion process.

Evaluating the need for BHRT

Candidates for Bioidentical Hormone Replacement Therapy include women who have had hysterectomies, who have personal or family histories of cardiovascular disease, osteoporosis or Alzheimer’s, and women with perimenopausal symptoms that affect their quality of life.

The most commonly reported symptoms of menopause are hot flashes, night sweats, fatigue, vaginal dryness, mood swings, tender breasts, fluid retention, memory lapses, sleep distrubances and decreased libldo.

Patients experience very few, if any, side effects while taking bioidentical HRT that is prescribed in physiologic doses.  Oral progesterone can cause drowsiness in about 2% to 5% of women who use it, an outcome of how it is metabolized by their hepatic systems.  It is therefore usually taken orally at bedtime.  Bioidentical hormones prescribed in non-physiologic doses can cause minor symptoms related to excessive supply, such as increased breast tenderness and headaches with too much estrogen and reversible mild acne or hair growth with too much testosterone.

The advantages of Bioidentical Hormone Replacement Therapy are that it is individualized, well-tolerated and produces exceptional symptom reversal in most cases.  The only possible disadvantage of compounded BHRT is that you must find a physician with advanced knowledge in prescribing Bioidentical Hormone Replacement Therapy.

Fast forward to the politics of our times

In the late 1960s, Wyeth-Ayerst Pharmaceuticals introduced Premarin in the U.S., a patented hormone replacement made from a pregnant mare’s urine.  Using young women’s urine, although available and cheap, was not a marketing option for Wyeth because women’s urine cannot be patented.  In the 1960s, getting a patent became the major driving force for drug production in the United States.  The marketing of patented drugs proved to be the best way to make money.  As the drug companies went public, the only thing that mattered was the bottom line.  (An interesting aside is that in the 1970s human insulin came to the market and changed management of diabetes for the better.)

For 30 years, Premarin (and subsequently Provera) was marketed to millions of women as the best way to eliminate symptoms of menopause and even prevent cancer, heart disease and osteoporosis.  In the early 1990s, while believing their own marketing data, Wyeth Pharmaceuticals (then treating more than one million women a year with Premarin and Provera) decided to partner with the National Institutes of Health to conduct a national study to evaluate the long term effects of Premarin in post menopausal women.  The study was conducted in hundreds of academic centers around the country.  Oddly, the premise for the study was based on assumptions that had no proof.

The NIH proceeded with the study with extensive financial support and free Premarin from Wyeth.  The unspoken goal of the study (from Wyeth’s point of view) was to prove that aging women needed Premarin to protect them from diseases of aging.  In 2002 the study was abruptly stopped because after almost 8 years too much data accumulated against Premarin, suggesting it increased the incidence of heart attacks and certain types of cancer and strokes in the study participants.

Based on the results of the Women’s Health Initiative the following happened

Extensive media coverage of the abrupt discontinuation of the study created mass confusion among millions of women who were taking the drugs and the doctors who were prescribing them.

The government was concerned the results of the study might expose their intimate involvement with Wyeth, the manufacturer of Premarin.  Consequently, a federal decision was made to distance the NIH from Wyeth by making a public statement to the media that all hormones are bad.  Nevertheless, Premarin and Provera were not removed from the market.

Little productivity has happened since the summer of 2002.  Grumblings against synthetic hormones and anecdotal reports in favor of bioidentical hormones could be heard around the country, but not much more.  Initially doctors were recommended to stop writing prescriptions for Premarin and Provera.  In time, Wyeth renewed its marketing efforts with low dose Premarin and recommended their use for a “short period of time as possible.”  No other research or options for women in menopause appeared available.

Women around the country started learning about bioidentical hormone options from a growing cadre of compounding pharmacists and cutting-edge physicians.  At the academic centers, no one talked of hormones if they could help it.  Drug company grants are vital to most academic research institutions.  Books for the public were published on bioidentical hormones but nothing filtered through to academic institutions.  In 2004 a book by Suzanne Sommers called The Sexy Years brought the option of bioidentical hormone therapies to the general public.  What had been a grassroots movement started to gain some steam.

By 2005, bioidentical hormones had reached millions.  Wyeth had lost billions of dollars in revenue and decided to retaliate.  First, they petitioned the FDA in October 2005.  Wyeth submitted a Citizens’ Petition to the FDA asking for stronger regulation and federal supervision of compounding pharmacies that produced bioidentical hormone preparations.  Keep in mind that the practice of pharmaceuticals and medicine are legislated at the state level.  In reality, Wyeth was asking the federal government to step in and protect their corporate financial interests.

Without any publicity, tens of thousands of women sent in letters and emails to the FDA asking for the Wyeth petition to be rejected.  The word was out “Please let me keep getting my bioidentical hormones from the compounding pharmacies.”  Women were asking to keep this viable option for treatment available.  Media attention to the Wyeth petition precipitated a swift reaction from the drug manufacturer.  Website information on menopause promoted the use of Premarin and used paid medical experts to bash bioidentical hormones as a marketing term.  This resulted in even more confusion.

Finally in October 2006, a controversial new book by Suzanne Sommers pushed the envelope even further.  While Ms. Sommers is an avid proponent of bioidentical hormones, her new book served to push bioidenticals further into the fire.   Wyeth and the North American Menopause Society (an association sponsered by Wyeth) retaliated through the AMA.  While everyone was arguing in 2006, the AMA passed a resolution in support of Wyeth asking for more regulations from the FDA in the area of compounded bioidentical hormones.  Fortunately, the United States Congress, in a display of wisdom, summarily rejected the FDA’s submitted regulation as requested by Wyeth.  The facts below speak for themselves:

1. Bioidentical hormones are medications, they are not natural products.   They are manufactured by drug companies from soy and yam oils.  The only natural thing about them is their molecular formula which is identical to the molecular formula of hormones our bodies make.  The difference between equine and bioidentical hormones is crucial information that most medical schools have not taught their students.

2. The term bioidentical is not a marketing term, it is a description term.  It describes the biologically identical molecular structure of bioidentical hormones.  It is a term that makes the important distinction between bio-identical hormones and non-bioidentical hormones.

3. Bioidentical estradiol, progesterone and testosterone are FDA approved.  Estradiol and testosterone can only be obtained by prescription through a licensed medical practitioner (some states allow nurse practitioners to write prescriptions while others do not).  Estriol is not FDA approved.

4. Progesterone is the only bioidentical hormone available without a prescription in low doses, 50 mg or less per unit dose.

5. Bioidentical hormones are commercially available from pharmaceutical companies in formulations in which they can patent the transport system such as in troches, gels, patches and creams.  Examples include but are not limited to the following: Vivelle patch, Climara, Estraderm, Estrace, Prometrium, Androgel.  These commercially available bioidentical hormones cannot have the dose adjusted.  They are standardized to specific doses.  Also, the hormones are not delivered in a steady state manner, but have peaks and valleys in blood levels as well as varying rates of absorption through the skin due to skin environmental factors at the time of application (dryness, moistness, flakiness, etc.).

6. To circumvent this dosing problem compounding is another viable option for the use of bioidentical hormones. Compounding pharmacies provide individualized preparations of bioidentical hormones in gels, creams, capsules, sublingual troches, and subdermal pellets.

7. Bioidentical hormone pellet insertion offers a sustained release and high compliance way to regulate blood hormone levels at a steady state.  They also avoid the problem of hepatic degradation to active metabolites (via the portal system) as seen with oral ingestion of testosterone and estradiol.

Bio-identical Hormone Replacement – Women

 

Bio-identical Hormone Replacement – Men

Contact Rejuvene for Bioidentical Hormone Replacement Therapy in Cincinnati

Rejuvene offers Bioidentical Hormone Replacement Therapy in Cincinnati Ohio. If you think you may be a good candidate for BHRT, please contact Rejuvene to schedule a consultation. Rejuvene has offices in Cincinnati Ohio and Northern Kentucky (Hebron, KY).