What are Bio-Identical hormones??
Bio-identical hormones have the same chemical structure as hormones naturally produced by the human body. The key to natural/bio-identical versues synthetic is the structure of the hormone. The chemical structure must exactly match the original hormone to fully replicate the human body's hormones.
Structural refrences that exist between synthetic or animal and human hormones may be responsible for the side effects that are experienced when NON bio-identical hormones are used for replacement therapy.
What are the goals of Bio-identical HRT?
* To alleviate the symptoms caused by the natural decrease in production of hormones by the human body
* To give the body protective benefits which were originally provided by naturally occuring hormones.
* To Re-etasblish hormone balance naturally
* To provide an adequate supply of deficient hormones in a form that is as close as possible to what is originally produced by the human body
* We provide Hormone Replacement Therapy as seen recently on the Oprah Show. Click here to view slideshow *
MSC Pharmacy can help you monitor your hormones using easy and accurate Saliva testing. We offer a free consultation with a licensed pharmacist.
Despite managing menstrual cycles and hormone fluctuations for decades, entering mid-life can often leave you overwhelmed by new, seemingly inexplicable physical and emotional symptoms.
Competent, accomplished women can find themselves wrestling with levels of insecurity not experienced since the rocky days of puberty.
To make matters worse, their body can feel like it's betraying them. Skin wrinkles and sags, hair grays and grows brittle, and sex can become uninteresting or routine.
If this sounds familiar, it's highly likely your hormones are out of balance and causing a wide range of symptoms.
Common Symptoms of Hormone Imbalance:
* Bleeding Changes
* Uterine Fibroids
* Water retention
* Tender Breasts
* Increased Forgetfulness
* Decreased libido
* Foggy thinking
* Mood swings
* Hot flashes
* Night sweats
* Vaginal Dryness
* Weight gain around waistline
How can you check if your hormones are balanced?
1- Schedule an appointment with one of our pharmacists
2- Our pharmacist will offer you a free consultation and a saliva test kit if needed at an economical
3- Results will be discussed with you and your physician.
4- If you do not already have a physician, we do work with several in the area, who have
experience in HRT treatment & can recommend one that would be appropriate for you.
4- If have to be placed on HRT, we will determine together with your doctor a customized
hormone supplementation program. We will monitor clinical outcome and adjust dosage's as
5- Testing can and will be repeated as necessary and follow up with your physician as advised.
Click below for a slide presentation about hormone replacement therapy
It's time to restore your hormones to their natural levels.
*We use plant derived hormones*
Archive for the ‘Hormone Replacement’ Category
Compounded Drugs Wednesday, February 11th, 2009
By Scott Rollins, MD
Compounded drugs, namely bioidentical hormones, are receiving a lot of attention lately, from FDA scrutiny to bashing from doctors to debates on Oprah. The reasons for criticism are suspect and the whole debacle deserves a response.
Compounded drugs require a doctor’s prescription and are simply prepared by a pharmacist who mixes or adjusts drug ingredients to customize a medication in order to meet a patient’s individual needs. The drugs are often made in a unique strength, or without certain chemical fillers or dyes, or in unique method of delivery such as topical creams or sub-lingual lozenges.
Is Compounding Safe?
The U.S. Food and Drug Administration (FDA) has stated that compounded prescriptions are ethical and legal as long as they are prescribed by a licensed practitioner for a specific patient and are compounded by a licensed pharmacist. The bulk drug substances used in a compounded medicine must qualify for use in compounding either via FDA-approved lists or via a listing in the U.S. Pharmacopoeia National Formulary (USP/NF), published by an independent standard-setting organization.
Pharmaceutical companies are regulated by the FDA to insure safety and consistency in their products. Compounding pharmacies are regulated by State Pharmacy Boards and regulations may vary from state to state.
In Colorado, the State Pharmacy Board applies the same standards for safety and consistency as does the FDA. When choosing a compounding pharmacy, you may wish to inquire about the specific standards, testing, raw materials, and quality control practices that the pharmacy uses to ensure the safety and quality of their medications.
Bioidentical hormones were being compounded long before drug companies even existed. Up until the 1950s most drugs were made by compounding. Now less than 1% of drugs are made by compounding pharmacies. This is not because of safety issues. Research and development needs combined with efficient production is what spawned the modern pharmaceutical industry.
Bioidentical Hormones - Compounded versus Commercial.
When there is no other option, use whatever drug comes closest to getting the job done! But, when there is a safer, better alternative, why use something inferior?
Bioidentical means 100% identical in molecular structure to the same molecule in our body. Not close, but identical.
I remember as a medical student asking a professor of gynecology, “Why would we give women estrogens synthesized from horse urine (which are not bioidentical), when we have the bioequivalent at our disposal?” The answer was that we had lots of studies showing it treated menopausal symptoms and protected the heart and bones of women.
It wasn’t until many years later that we learned about the many risks of hormones that are not bioidentical nor administered in a physiologic manner.
Commercially Produced Hormones.
There are plenty of bioidentical estradiol formulations available from commercial drug companies, in topical and oral forms. Caveat: Don’t use oral estrogens – use topical or sub-lingual.
There is only one commercial form of bioidentical progesterone (Prometrium) which is in an oil capsule for oral consumption. I am not aware of any commercial (prescription strength) topical formulations. Caveat: Oral is ok for progesterone, but the absorption is variable and you will get more active (sedating) metabolites from the oral route.
Bioidentical testosterone is available from commercial drug companies in gel, patch, buccal and oral forms. Caveat: Oral is just not absorbed well. The other formulations are ok – but they are lower dose and don’t tend to give very impressive blood levels in men.
There are commercially produced injections for estradiol and testosterone which are “salts”, that is, the hormone is bound to another chemical making it a “salt”. These are reasonable alternatives.
The Problems with Commercial Hormone Products.
As one can see there are numerous forms of bioidentical hormones available from commercial drug companies. These are fine products.
The problems start with not finding all three ovarian hormones in one single product. So women will end up taking 3 different products.
The second issue is not having them available in a consistent route for administration. So now we have three products and three different routes. Imagine a woman on an estradiol patch, a progesterone capsule, and testosterone buccal (inside cheek and gum) strip.
Last is the issue of dosing. There are a limited number of strengths available with commercially produced hormones. For some women this is not an issue, but for many we need to make subtle adjustments to the strength in order find the right dose.
For men, the whole issue is simpler as only testosterone is needed and that is fairly easily accomplished with commercial preparations.
Why the Controversy?
The controversy over compounding pharmacies really started when compounded bioidentical hormones started taking some of the market share from the commercially produced drugs used for hormone replacement. The controversy is about money, not safety or purity.
A natural substance can’t be patented and sold for profit. So, what drug companies do is invent some substance that is “close enough” to see similar effects in the body, but different enough to be unique and thus get a patent. Then they spend lots of money to do large studies and hope the drug shows more benefit than harm.
Drug studies are usually funded by the company making a new drug. The FDA oversees the industry, and receives lots of money from drug companies. These studies end up published in our medical journals, before which we doctors genuflect our intelligence and worship as the sole source of knowledge. Thus, the pharmaceutical industry, in cahoots with the FDA, supplies the “cookbook” that feeds the pipeline for modern medicine.
I am not against pharmaceutical companies or commercial drugs! Quite the contrary – pharmaceutical companies spend billions to develop wonderful new medications that save lives and promote health – I prescribe those drugs routinely and I am very grateful for them.
The issue is simply not accepting as gospel everything the drug industry claims. For example, remember Vioxx, the arthritis drug made by Merck? According to the British medical journal The Lancet, the actions of both Merck and the US Food and Drug Administration (FDA) contributed to the nearly 30,000 excess cases of heart attacks and sudden cardiac deaths that resulted from the use of the drug between 1999 and 2003. While Merck sought to cover up the danger of its own drug to protect its bottom line, the US government aided the company by approving sale of the drug without conducting any serious investigation into potential harmful consequences of its use. Merck and the FDA let that one slide until there were enough deaths they were forced to “let the cat out of the bag” and recall the drug.
The Vioxx example is not my opinion, but only one observation of how the system works. Draw your own conclusions.
For a great article on FDA interference with compounding, check out Dr Johnathan Wright’s excellent review “FDA Bans Hormone Produced by Human Body”
The Debate Goes On.
For centuries the “apothecary” was the compounding pharmacist. Modern medicine owes much of the origin of pharmacology and chemistry to the apothecary. The modern pharmaceutical industry owes its origin to the apothecary.
I have thousands of patients that are doing very well taking compounded hormones. I also have many who doing very well taking commercially produced hormones. It is simply a matter of the doctor and patient determining what is best for the patient.
I personally inspect and closely monitor the compounding pharmacies I send patients to. I also play an active role in educating and consulting with the compounding pharmacists and their staff. In the same manner I try to research the pros and cons of new medications coming from the pharmaceutical companies.
So now we have a debate as to whether commercial drug companies are better than compounding pharmacies. Perhaps we need to realize they are simply different paths alongside the same road. At the end of the day, who do you trust most with your health – a pharmacist or a corporation? At least for now you still have the choice.
Wednesday, January 28th, 2009
By Scott Rollins, MD
Many women are denied hormone replacement therapy (HRT) due to a fear of blood clot formation, particularly if they have had a blood clot in the past or already have a known risk factor.
The risk of a blood clot in a large vein (thrombosis) is increased with the administration of 1) estrogens given by the oral route, 2) conjugated estrogens, and 3) numerous progestins.
The risk of blood clots is not increased with non-oral administration (sub-lingual or topical) of bioidentical estrogens or progesterone.
Let’s look carefully at the evidence for each of the above statements.
1) Orally administered estrogens increase risk of blood clotting. This is because the hormone is absorbed from the gut directly into the hepatic circulation, meaning it first gets processed by the liver prior to being circulated throughout the body. This is called first pass metabolism.
The result is that the liver is hit with a sudden blast of hormone that it is required to process - this is not the normal physiologic routine, in which hormones are secreted into the blood stream, distributed into the body tissues, and finally processed by the liver.
First pass metabolism of hormones is not natural and one result is that the liver makes more chemicals of inflammation and there is an increase in the factors that encourage blood clotting.
The risk of blood clots is highest with oral estrogens, highest in the first year of use, highest when other risk factors are present and highest when progestins are also used (more on that below). Trans-dermal (topical) estrogens do not appear to increase the risk of blood clots:
A 2001 study showed oral estrogen causes mixed results as to risk factors for heart disease, and again causes an increased risk for blood clot. Trans-dermal estrogen had no effect on the risk for clots:
Known risk factors for blood clots such as obesity, age, and genetic mutations (e.g. Factor V Leiden) are worsened with oral estrogen and progestins, but again topical administration does not carry this risk
2) Conjugated estrogens increase the risk of blood clots. Conjugated means bound to another chemical. Conjugated (e.g. Premarin, Cenestin) and Esterified (e.g. Menest) estrogens are similar in that they are bound to another chemical, usually a sodium salt. Many drugs used for hormone replacement are simply slight modifications to our native hormones, with a variety of chemicals simply attached to make a similar (but different) molecule. The end result is a drug that sometimes acts like the native hormone – sometimes not. And… there are sometimes unexpected side effects not seen with the native hormone. Why even bother when we have the native hormone to choose? It’s called patents and profit, period.
Conjugated estrogens increase risk of blood clots, whereas esterified estrogens do not:
Our suggestion is to take neither conjugated or esterified estrogens since bioidentical estrogens are widely available.
3) Progestins are chemicals that stimulate progesterone receptors. As with conjugated estrogens, they are not identical to our native progesterone, and may stimulate lots of other receptors. For example, many progestins will also stimulate estrogen or testosterone receptors, and some even stimulate aldosterone (an adrenal gland hormone) receptors. Many of them, namely medroxy-progesterone (MPA) or Provera, will cause a significant increase in the factors that encourage blood to clot! Progesterone does not increase risk of blood clotting.
More results from the Women’s Health Initiative, showing increased risk of blood clots and stroke with oral estrogen and especially with MPA:
MPA increases risk of blood clots, progesterone does NOT:
Finally, a 2008 review in the journal “Maturitas” that nicely summarizes the correct method for HRT – non-oral estrogen and bioidentical progesterone - which minimizes the risks while conferring the benefits of HRT:
Wednesday, December 24th, 2008
By Scott Rollins, MD
Here we go again… The evil Provera, having already sounded the dirge on hormone replacement, now returns from the dustbin of science to give the news media (and doctors) more bad news to shoddily spread across the headlines and confuse patients.
Here is an example what we are seeing in the news: “Hormones Cause Breast Cancer”. Which hormones exactly? Let us examine the issue more closely and review some of the real data on HRT and breast cancer, at least as far as progesterone is concerned.
Recent results from the Women’s Health Initiative (WHI) again show an increased risk of breast cancer with the use of Provera, even for several years after stopping it, but then (the makers of Provera reassure us) the risk drops off with time. The original WHI data showed a 1.4X relative risk (26% increase) for breast cancer in women taking the mixture of Premarin and Provera.
*Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321-333.
If one brand of automobile is defective, and killing people as a result, should we then cast blame on the entire auto industry and recall every brand of automobile? That is precisely what is happening in the world of hormone replacement therapy (HRT)!
Provera (medroxy-progesterone) is a drug that is similar to our native progesterone – not identical, merely similar, like hundreds if not thousands of chemical compounds that will stimulate progesterone receptors in the body. These chemicals are called “progestogens” and synthetic drugs in this category are known as “progestins”.
A Bioidentical hormone has a molecular structure that is 100% identical to the hormone molecule the body makes. Progesterone is bioidentical, Provera is not, and this does make a difference!
There are numerous reviews that suggest progesterone and some progestins have a protective effect on breast tissue:
*Mauvais-Jarvis P, Kuttenn F, Gompel A, Benotmane A. Antiestrogen action of progesterone in the breast. Pathol Biol (Paris) 1987;35:1081- 1086. [Article in French]
*Mauvais-Jarvis P, Kuttenn F, Gompel A. Estradiol/progesterone interaction in normal and pathologic breast cells. Ann N Y Acad Sci 1986;464:152-167.
*Gorins A, Denis C. Effects of progesterone and progestational hormones on the mammary gland. Arch Anat Cytol Pathol 1995;43:28-35. [Article in French]
*Inoh A, Kamiya K, Fujii Y, Yokoro K. Protective effects of progesterone and tamoxifen in estrogen-induced mammary carcinogenesis in ovariectomized W/Fu rats. Jpn J Cancer Res 1985;76:699-704.
*Wren BG, Eden JA. Do progestogens reduce the risk of breast cancer? A review of the evidence. Menopause J North Am Menopause Soc 1996;3:4-12.
Low levels of progesterone have been associated with increased risks of breast cancer:
Progesterone, and NOT progestins, provides a control mechanism to regulate the proliferative effects of estrogen. This means it prevents cancer:
*Chang KJ, Lee TT, Linares-Cruz G, et al. Influences of percutaneous administration of estradiol and progesterone on human breast epithelial cell cycle in vivo. Fertil Steril 1995;63:785-791.
*Formby B, Wiley TS. Progesterone inhibits growth and induces apoptosis in breast cancer cells: inverse effects on Bcl-2 and p53. Ann Clin Lab Sci 1998;28:360-369.
*Desreux J, Kebers F, Noel A, et al. Progesterone receptor activation – an alternative to SERMs in breast cancer. Eur J Cancer 2000;36:S90-S91.
*Malet C, Spritzer P, Guillaumin D, Kuttenn F. Progesterone effect on cell growth, ultrastructural aspect and estradiol receptors of normal human breast epithelial (HBE) cells in culture. J Steroid Biochem Mol Biol 2000;73:171-181.
A French study showed no increased risk of breast cancer in women using progesterone cream topically, and actually a reduced risk when adding a progesterone capsule:
*Plu-Bureau G, Le MG, Thalabard JC, et al. Percutaneous progesterone use and risk of breast cancer: results from a French cohort study of premenopausal women with benign breast disease. Cancer Detect Prev 1999;23:290-296.
Another French study showed no increased breast cancer risk when taking progesterone as opposed to synthetic progestins:
*de Lignieres B, de Vathaire F, Fournier S, et al. Combined hormone replacement therapy and risk of breast cancer in a French cohort study of 3175 women. Climacteric 2002;5:332-340.
Last, the largest study to date that most conclusively addresses the debate over progesterone and breast cancer. The French E3N-EPIC (European prospective investigation into cancer and nutrition) is a cohort study looking at over 50,000 women. It showed the same results as the WHI in women using synthetic progestins, a 1.4X relative risk (26% increase) in breast cancer. But, it showed a 0.9X relative risk (a decrease!) in women using progesterone:
*Fournier A, Berrino F, Riboli E, et al. Breast cancer risk in relation to different types of hormone replacement therapy in the E3N-EPIC cohort. Int J Cancer 2005;114:448-454.
For a good example of some of the complexities of progestins and their effects on breast tissue, as well as insight into the pitfalls of oversimplifying HRT, see:
*Pasqualini JR. Progestins and Breast Cancer. Gynecol Endocrinol. 2007 Oct;23 Suppl 1:32-41.
Please review these studies by going to PubMed and enter the lead author and title. E.g. to search the above example, enter: Pasqualini JR. Progestins and Breast Cancer.
I am not aware of any prospective trials that assess the safety of bioidentical progesterone with respect to breast cancer. Distinguishing causality from mere correlation cannot usually be done with results of a cohort study alone, but the above referenced cohort studies provide a strong case for the safety of bioidentical progesterone.
Bioidentical HRT is beneficial for quality of life, providing symptom relief for acute menopausal symptoms as well as preventing many symptoms and diseases associated with aging. Physicians would be well served to take the time to study these issues and provide hormone replacement for women and men based on sum total of the available science and not just the latest pharmaceutical panderings.
Sunday, December 21st, 2008
From AdvantAge Integrative Medicine
DHEA decreases with age, declining levels can begin after the age of 30. DHEA is produced by the adrenal glands and has two types of actions in the body:
1. Conversion: DHEA converts in the body into more potent male and female hormones including testosterone and estrogen
2. Actions of its own: DHEA enhances the immune system and may protect the blood vessels against atherosclerosis
• Increased DHEA can be a result of emotional stress. Intake of foods high in protein or saturated fat can increase levels
• Decreased DHEA can be caused by a diet rich in sugar, sweets, and high fiber cereal (such as whole grain or bran flakes)
Signs and Symptoms of DHEA Deficiency
• Fatigue and/or depression
• Decreased immune system function
• Decreased sexual desire (men and women)
• Decreased exercise tolerance and loss of muscle tone
• Dry skin and eyes
• Reduced axillary (armpit) and pubic hair
Requirements for Monitoring Therapy:
• Baseline blood testing of DHEA level. Concurrent testing of other hormones as appropriate
• Periodic blood testing of DHEA levels to assure adequate dosing
DHEA may be found at compounding pharmacies and health food stores, concentrations vary widely so a knowledgeable professional should assure the dose is correct
• Oral DHEA is preferred
• Proper dosing will vary and depends on the amount of DHEA deficiency and the response to treatment
• Improvements may be seen after 3-4 months; six months of treatment is necessary to obtain the full effects of DHEA treatment
Signs and Symptoms of Too Much DHEA
• Unwanted body and/or facial hair
• Acne or oily skin
• Menstrual cycle disturbances
Risks and Benefits of Treatment
• Replacement is contraindicated if there is a history of breast, uterine or prostate cancer
• Caution must be taken in the presence of preexisting liver disease
• DHEA should not be taken if there is no deficiency
• May worsen an untreated cortisol deficiency
• Improved energy levels
• Improved immune system function
• Decreased symptoms of other male and female hormone deficiencies ( such as testosterone)
How to Boost Your DHEA Levels
• Eat a balanced diet of fruits, vegetables, meat, poultry, fish and eggs
• Limit intake of alcohol, vinegar, and caffeinated drinks
• Limit sweets, soft drinks, breads, pastas and cereals
Sunday, December 21st, 2008
From AdvantAge Integrative Medicine
• Pregnenolone is a precursor to many hormones. It is formed from cholesterol and its formation is the first step to a complex process that produces all “steroid” hormones. Common steroid hormones include estrogens, progesterones, androgens (testosterone) and glucocorticoids (cortisol). Therefore, a decline in pregnenolone can create a generalized decline in all of the steroid hormones
• Pregnenolone also functions as a neurotransmitter in the brain and it works particularly in the area of the brain responsible with memory. Many patients report an improvement in memory when taking pregnenolone
• Pregnenolone progressively declines with age, which is why it is an important cause of the decline of all steroid hormones
Signs and Symptoms of Pregnenolone Deficiency
Since pregnenolone deficiency can lead to a deficiency of other steroid hormones, an evaluation of male and female sex hormones and, if necessary, glucocorticoid deficiency evaluation will be done concurrently
Direct effects of Low Pregnenolone:
• Declining memory function
• Declining mental awareness
Indirect effects of Low Pregnenolone:
• Fatigue and reduced mobility
• Dry skin
• Joint and muscle pains
Requirements for monitoring therapy:
• Baseline blood testing of pregnenolone level. Concurrent testing of other steroid hormones as appropriate may also be tested
• Periodic blood testing of pregnenolone levels to assure adequate dosing
Pregnenolone may be found at compounding pharmacies and health food stores, concentrations vary widely so a knowledgeable professional should check that the dose is correct
• Oral pregnenolone is preferred
• Pregnenolone is usually taken in the morning to help improve memory through the day
• It may take 3-4 months until improvements are seen with memory and mental awareness
• Dosing depends of the amount of pregnenolone deficiency
Signs and Symptoms of Too Much Pregnenolone
• Oily skin
• Excess of hormones derived from pregnenolone
Risks and Benefits of Treatment
• Doses over 200- 300mg daily for long periods can be harmful to the liver and can cause signs of pregnenolone excess
• Caution must be taken in treatment if there is any preexisting liver disease
• Improved memory
• Enhancement of treatment of other steroid hormone deficiencies
How to Boost Your Pregnenolone Levels
• Get adequate amounts of sleep
• Focus on a balanced diet of fruits and vegetables with adequate amounts of meat, fish, eggs and poultry
Estrogen Dominance is Really Progesterone Deficiency
The term “Estrogen Dominance” can be confusing at times because it is less related to the amount of circulating estrogen and more related to the ratio of estrogen to progesterone in the body. Contrary to popular belief, Menopause and PMS are not the result of estrogen deficiency although estrogen levels do decline during the latter phases of a woman’s reproductive cycle.
More relevant is that the estrogen levels drop by approximately 40% at menopause while progesterone levels plummet by approximately 90% from premenopausal levels. It is the relative loss of progesterone that causes the majority of symptoms termed “Estrogen Dominance”. The disproportionate loss of progesterone begins in the latter stages of a woman's reproductive cycle, when unbeknownst to her the luteal phase of the menstrual cycle begins to malfunction. The malfunction is initiated when the remnant tissue of the follicle (corpus luteum), the primary source of progesterone, begins to lose its functional capacity. By about age 35 many of these follicles fail to develop, creating a relative progesterone deficiency. As a result, ovulation does not always occur and progesterone levels steadily decline. It is during this period that a relative progesterone deficiency, or what has become known as estrogen dominance, develops.
· Mood Swings
· Uterine Fibroids
· Decreased Libido
· Irregular Periods
· Heavy Menstrual Bleeding
· Short-term Memory Loss
· Hot Flashes
· Lack of Concentration
· Vaginal Dryness
· Dry, Thin, Wrinkly Skin
· Water Retention
· Thinning of Scalp Hair
· Diffuse Aches and Pain
· Increased Facial Hair
· Weight Gain: Hips, Thighs and Abdomen
· Bone Mineral Loss (Osteoporosis)
· Sleep Disturbance (Insomnia, less REM sleep)
· Breast Tenderness / Fibrocystic Breasts
Patients experiencing a majority of these symptoms most likely will benefit from natural hormone replacement. The most effective way to assess hormone status is to test saliva for the appropriate hormone levels. Saliva is the best method for testing "functional (active)" tissue levels of hormones.
The Progesterone/Estradiol (Pg/E2) reference ranges are optimal ranges determined by Dr. John R. Lee M.D. While they are not physiological ranges, they are optimal values for the protection of the breasts, heart and bones in women, and the prostate in men. Salivary values within these ranges have been shown by Dr. Lee to decrease both breast and prostate cellular proliferation, thereby providing protection to these vital tissues.
Health Disclaimer: All information given about health conditions, treatments, products and dosages are not intended to be a substitute for professional medical advice, diagnosis or treatment. This is provided only as a suggested guideline.
MARCH 16, 2009
The Truth About Hormone Therapy
Mainstream medicine has been given a wake-up call on a matter critical to the health of 65 million women in the U.S. At issue are the options for treatment of menopause symptoms that cause significant health problems for women in mid-life as their bodies produce fewer hormones. It doesn't seem like a complicated problem, given advances in medical science. Yet hormone-replacement therapy has become a textbook example of how special interests, a confused medical establishment, and opportunists can combine to complicate the issue and deny patients access to safe and effective treatments.
Until seven years ago, women going to conventional doctors were prescribed the FDA-approved synthetic hormone Premarin, derived from the urine of pregnant horses; Provera, a synthetic progestin; or Prempro, a combination of the two. Premarin was the bestselling drug in the U.S. in 2001, generating $2 billion a year for Wyeth.
In 1994 a study led by the National Institutes of Health called the Women's Health Initiative (WHI) was started with the hope of establishing that Premarin and Provera would, beyond relieving menopause symptoms, protect aging women from heart attacks, strokes, osteoporosis and cancer.
On July 9, 2002, however, the WHI came to an abrupt halt. The study proved unequivocally that the drugs were unsafe and significant factors in increasing the risk of heart attacks, strokes and breast cancer in the more than 16,000 women studied.
This led doctors to take millions of women off Premarin, Prempro and Provera overnight. Predictably, these women started to feel horrible in the aftermath of the drugs' sudden withdrawal, and their physicians told them there were no alternatives. Instead they prescribed antidepressants or birth control pills with shoddy results.
One year after this disaster, the AmericanCollege of Obstetrics and Gynecology developed new guidelines that encouraged physicians to prescribe the same drugs in lower doses for shorter periods of time. Yet, and this is key, the safety of this "low dose option" was never proven scientifically.
Meanwhile, many conventional physicians have ignored the effectiveness of "bioidentical" or natural progesterone, which is formulated to be identical to the progesterone molecule that is produced by the human body.
There are 25 years of scientific research with hundreds of studies in the U.S. and Europe that have demonstrated that bioidentical hormones, estradiol and micronized progesterone, are equally or more effective than synthetics -- and safer. Yet mainstream medicine has buried its head in the sand and refused to take these studies seriously.
While Europeans have long used bioidenticals, no commercially available bioidentical hormones existed in the U.S. until 1998, when a few pharmaceutical companies obtained FDA approval for an array of bioidentical estrogen preparations and one progesterone preparation. Unfortunately, due to drug companies running the medical profession by controlling what goes into medical education, most doctors never get educated about bioidentical hormones or the way in which different hormone molecules work. With Premarin and Provera dominating the market, drug companies had no incentive to spread the word.
Today the distinction between bioidentical/natural progesterone and the synthetic progestin Provera remains widely misunderstood. Progesterone is used by fertility specialists to protect pregnancy, while medroxyprogesterone (Provera) is used in the morning after pill and in birth control pills to prevent pregnancy. Their actions are totally different and antithetical.
Sadly, seven years after the WHI study finding Premarin/Provera unsafe, the hormone-replacement debate can be summed up in three words: confusion, ignorance, misinformation. Meanwhile, millions of women have embraced bioidenticals, leaving their conventional physicians looking stubborn and foolish.
The medical establishment must stop kowtowing to drug companies and start serving women's best interests -- and that involves widely prescribing bioidentical hormones. This will lead to healthier, happier women and, in the long run, help reduce America's skyrocketing health-care costs.
Drs. Schwartz, Holtorf and Brownstein are founding members of the Bioidentical Hormone Initiative, a nonprofit group of physicians dedicated to patient and physician