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The History and the Politics of Bio-Identical Hormone Therapy

bio identical hormone therapy

A Historical View Of The Rise Of Bio-Identical Hormones

The history of therapeutic hormone use actually stretches back more than a thousand years. The earliest examples come from Ancient China. Here, older noblewomen treated the symptoms of menopause by using supplements concocted from the dried urine of younger women. This was effective because the urine contained trace amounts of metabolically-processed hormones like progesterone, estrogen, and testosterone. This is by no means a solitary example, and the phenomenon of older women using young women’s urine to treat the symptoms of aging occurs over and over again.

In the modern age, proper research on synthetic hormones and equine (horse) hormones started in the 1940s. This has led to modern hormone replacement therapy or HRT. Based on this research, conventional medical practitioners can offer a range of substitute hormones (estrogens and progestins) which are molecularly similar to, but not identical to, the human body’s own hormones. Bio-identical hormones were known to be an effective alternative since at least the 1930s. The problem in the past was that these hormones were difficult to administer. They could not survive the digestive tract; the only effective way to introduce them to the body was via painful oil-based intramuscular injections. Bio-identical hormones fell by the wayside due to the difficulty in administering them – and due to the fact that these natural substances could not be patented by drug companies.

Conjugated equine estrogens, or CEEs, became the first major non-bio-identical hormone success story. Taken orally and heavily marketed by their manufacturers, these hormones made estrogen replacement therapy (ERT) popular up until the mid-70s. ERT was shown to have links to endometrial cancer, which sank its viability for a time. Further research demonstrated that endometrial cancer was only a problem when women’s levels of estrogen and progesterone were unbalanced. Progestin, a synthetic imitation of natural progesterone, was developed to balance out the synthetic estrogens being used in hormone replacement therapy. As though the field was not already complicated enough, pharmaceutical and medical literature muddied the waters considerably by using the terms “progesterone” and “progestin” interchangeably. Both patients and doctors began to assume that the two compounds had the same effect on the human body, which is definitely not the case.

While extensive research has verified the positive impact that HRT can have, there are still a lot of women who struggle with peri-menopausal symptoms and suffer through a reduction in their quality of life without any HRT. The demographic boom of women from the baby boom generation entering menopause has brought to light another issue with HRT. Many of them use synthetic equine HRT treatments to handle peri-menopausal symptoms. These non-bio-identical compounds often deliver incomplete relief or replace menopausal symptoms with unwanted side effects.

Every woman has a different reaction to HRT using non-bio-identical synthetics. Synthetic hormones are metabolized within the body to create derivative hormones, and these consequential hormones bind to receptor sites more firmly (two to three times more firmly) than the body’s own hormones. There are profound chemical differences between naturally-occurring human hormones and synthetic non-bio-identical replacements. Some specific animal estrogens (like Equilin, a horse estrogen) bind to receptors up to 18 times more strongly than human hormones. The metabolites produced by such synthetics can also cause hypertension.

Non-bio-identical progestins upset the body’s cholesterol levels in unhealthy ways and decrease sex hormone-binding globulin or SHBG. Drops in SHBG may lead to elevated levels of free sex hormones and increased androgenicity.

The numerous side effects that come with non-bio-identical HRT make it less attractive to women who try it. It’s estimated that the number of postmenopausal women who stick to a long-term HRT schedule may be as low as 20 percent.

Synthetic hormones do not function in the same steroid pathway as natural precursor steroids, making it impossible to balance hormone levels from moment to moment.


HRT Using Bio-Identical Compounds

Other common names for bio-identical HRT include “human-identical” HRT or “natural” HRT. Though bio-identical steroids are not derived from human sources, they are chemically and structurally identical to human hormones. The source of most bio-identical hormones is a plant oil known as diosgenin, an excellent chemical match to the cholesterol used as a precursor steroid hormone in the human body. Diosgenin is harvested from plants like wild yams and soybeans. The oil is easy to cultivate in vast quantities, and it can be extracted from thousands of different plant species.

Careful chemical processing converts diosgenin into bio-identical steroids that match endogenous human steroids in every respect. The conversion process also removes potential allergens from the plant material.

The human body has over 15 different steroid hormones. They interact in a complex enzyme system that allows the body to adjust steroid levels from moment to moment. The overall system is called the steroid hormone cascade. Shortages or over-abundances of particular steroids can cause a range of different symptoms. Keeping the cascade in good working order also requires raw material in the form of precursor hormones. Examples include pregnenolone and cholesterol. These compounds are converted through multiple enzyme steps into the steroid hormones that keep the body in balance.

Compounding BHRT can produce a range of bio-identical steroids to make up any deficiencies in a woman’s body. The exact steroid combination can be customized to suit specific patients. Compounding pharmacists collaborate closely with prescribing physicians to create unique formulations for individual women. Compounding pharmacists benefit from painstaking training and vast amounts of experience in order to ensure that their formulations are pure, standardized, and fully compliant with best practices. Professional organizations give compounding pharmacists full access to the latest research, guidelines, and formulas as well as robust technical support and supplies of trustworthy pharmaceutical-grade hormones. The care taken in formulating natural HRT compounds ensures that patients receive the highest possible quality in their products. Prescribers need to be familiar with the compounding process to meet the growing demand for compounded BHRT. Both patients and prescribers can get referrals from the International Academy of Compounding Pharmacists (IACP).

In recent years the commercial HRT market has seen the arrival of a few bio-identical hormones. Though it is still impossible to patent a naturally-occurring compound, manufacturers can (and do) patent delivery systems. Because these delivery systems are not foolproof – some individuals are allergic to the glue in estradiol patches or the peanut oil in progesterone capsules – there are still sharp limits on the utility of commercial hormone therapy even when bio-identical ingredients are used.

Assessing the Need for BHRT

BHRT candidates include women with osteoporosis, a family or personal history of cardiovascular disease, those who have undergone hysterectomies, there with Alzheimer’s or women with perimenopausal symptoms which affect their quality of life.

Hot flashes, fatigue, night sweats, mood swings, vaginal dryness, fluid retention, tender breasts, sleep disturbances, memory lapses, and decreased libido are some of the symptoms associated with menopause that are the most commonly reported.

When Bio-identical HRT is taken and is prescribed in doses that are, very few if any side effects have been reported by patients. In about t 2% to 5% of women that use oral progesterone, drowsiness is experienced; this outcome is due to the way it is metabolized by their hepatic systems. This is usually why it is taken orally at bedtime. Minor symptoms can be caused by bio-identical hormones prescribed in doses that are non-physiological which are related to excessive supply, for example headaches and increased breast tenderness with too much estrogen or with too much testosterone reversible hair growth of mild acne.

Moving on to our current Politics.

Premarin was introduced in the U.S. by Wyeth-Ayerst Pharmaceuticals in the late 1960s, it is a hormone replacement which is patented and made from the urine of a pregnant mare. Although cheap and available, the use of young women´s urine was not a marketing option for those at Wyeth because you cannot patent women’s urine.

Obtaining a patent in the 1960s became a major driving force in the United States for drug production. It was proven that the best way to make money was through the marketing of patented drugs. As drug companies started to go public, the bottom line was the only thing that mattered. An aside which is interesting is that human insulin in the 1970s came into the market and changed diabetes management for the better. Is it that women in menopause do not matter?

Premarin and thereafter Provera was marketed for thirty years to millions of women as being the best way of eliminating menopause symptoms and even preventing osteoporosis, heart disease and cancer. As they bought into their own marketing information, Wyeth Pharmaceuticals in the early 1990s which at that point treated over one million women, with Premarin and Provera on a yearly basis decided to become partners with the National Institutes of Health and conduct a national study which would evaluate Premarin´s and Provera´s long term effect in women who are post-menopausal. In hundreds of academic centers all over the country the study was conducted. The premise of the study was oddly based on assumptions with no proof!

The NIH moved forward with this study with the ample financial support as well as free Premarin from Wyeth. The goal of the study which was an unspoken one form the point of view of Wyeth was to prove that women who were aging needed to protect themselves from the diseases associated with aging with Premarin. The studded was abruptly stopped in 2002 because after nearly eight years, and overload of data accumulated against Premarin which suggested that it increased the amounts of heart attacks as well as certain kinds of cancers and strokes in those who participated in the studies.

The following happened based off of the results of the Women’s Health Initiative:

Mass confusion was created amongst the doctors prescribing the drugs and the millions of women taking them due to the extensive media coverage of the discontinuation of the study which was so abrupt.

It was the government’s concern that the study’s results may expose their close relationship with the manufacturers of Premarin; Wyeth. As a result, they made a federal decision to distance Wyeth and the NIH through a public statement to the media stating that all hormones were harmful. Nonetheless, neither were Premarin or Provera removed from the market.

Since the summer of 2002, not much productive has occurred. Complaints about synthetic hormones as well as anecdotal reports favoring bio-identical hormones can be heard all around the country, however nothing more. It was at first recommended that doctors no longer write prescriptions for Premarin or Provera. As time went by however, the marketing efforts of Wyeth were renewed with Premarin and Provera that were low doses and their use was recommended for “as short of a time period as possible.” There appeared to be no other option or research available for women in menopause. These drugs are still being prescribed!

Women all over the country began to learn about options for bio-identical hormones form a growing nucleus of “alternative” medicine doctors and compounding pharmacists. No one at the academic centers talked of hormones of it could be avoided. To most institutions for academic medical research, drug company grants are crucial. Books on bio-identical hormones were published for the public however nothing filtered through the academic institutions. A book by Suzanne Summers which was published in 2004 called “The Sexy Years” brought to the public the option of bio-identical hormone therapies. What was merely a grassroots movement began gaining some steam.

Millions had been reached by bio-identical hormones by 2005. Billions of dollars had been lost in revenue by Wyeth and they decided to retaliate. What they first did in October 2005 was petition the FDA. A citizen’s petition was submitted by Wyeth to the FDA requesting more federal supervision and strong regulation of compounding pharmacies which produced the bio-identical hormone preparations. Bear in mind that it is at a state level that the practice of pharmacy as well as medicine is legislated. What Wyeth was really asking of the federal government was for them to step in to protect Wyeth´s corporate financial interests.

There was no publicity, and yet letters and emails were sent by tens of thousands of women to the FDA requesting the Wyeth’s petition be rejected. The word had gotten out “Please allow for me to continue receiving from the compounding pharmacies, my bio-identical hormones.” What women were requesting was that this viable option for treatment remains available. A swift reaction was precipitated from the drug manufacturer due to the media attention toward the Wyeth petition. As a marketing term, the use of Premarin was promote by information found on websites on the subject of menopause and medical experts were used to fight against bio-identical hormones. The result of this was far more confusion.

In 23006, while everyone was arguing, a resolution was passed by the AMA which supported Wyeth and asked the FDA increase regulation in the compound bio-identical hormone area. Fortunately, in a display of wisdom, the United States Congress summarily rejected the regulation submitted by the FDA as Wyeth had indirectly requested. Below you will find facts which speak for themselves.

1. Bio-identical hormones are not natural products, they are medications. Drug companies manufacture them from yam and soy oils. Their molecular structure is the one thing about them that is natural and it is identical to the molecular structure of the hormones made by our bodies. Information which most schools don’t teach their students is the important difference between bio-identical and equine hormones.

2. The term bio-identical is not a term for marketing, it is in fact one that is descriptive. The structure which is a biologically identical molecular one of bio-identical hormones is what it describes. The term is one which makes an important distinction between hormones that are bio-identical and those which are non-biologically identical.

3. Bio-identical testosterone, progesterone, and estradiol are all FDA approved. You’re only able to obtain estradiol and testosterone by prescription via a medical practitioner that is licensed, there are however some states that do and other that do not allow nurse practitioners to write these prescriptions. When it comes to hormone therapy, estradiol is not FDA approved.

4. The only bio-identical hormone which is available without the need of a prescription is progesterone, only in low doses however, for 50mg or less per a unit dose.

5. Bio-identical hormones are available commercially from pharmaceuticals in formulas which they are able to patent their system of transportation, for example in gels, creams, troches, and patches. Some examples include yet are not limited to: Climara, Estrace, Androgel, Vivelle patch, Estraderm, and Prometrium. The bio-identical hormones which are commercially available cannot have any adjustments made to their dose. They have been standardized to doses which are specific. They hormones are also not delivered in a steady state way, they have peaks as well as valleys in blood levels, they also have various rates of absorption via the skin because of factors associated with skin environmental factors at the moment of application, for example; moistness, dryness, flakiness, etc.

6. To bypass this issue with dosing, another viable option when it comes to the use of bio-identical hormones is compounding. Individualized preparation of bio-chemical hormones are provided by compounding pharmacies in creams, gels, capsules, subdermal pellets, and sublingual troches.

7. A sustained release as well as high compliance way of regulating blood hormone levels at a state that is steady is offered by bio-identical hormone pellet insertion. They also prevent the issue of hepatic degradation to metabolites that are active (through the portal system) as is observed with testosterone estradiol which is ingested orally.

What is required for the Future?

What we are standing in today is in the middle of a crisis between politics, science and the motive of corporate profit. What is at stake is the health of men and women. We require university studies which nonprofits and the government fund to follow up on the option of bio-identicals a potential for better health. In terms of human suffering as well as health costs, the savings could be enormous.

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