Compounded Bioidentical Hormone Therapy: All About Marketing, Not Science
Compounded Bioidentical Hormone Therapy: Mature Women's Centre Position Statement
Oprah Winfrey’s recent search for the truth regarding hormone therapy for women navigating through the menopausal transition has rekindled a contentious and alarming debate. The Mature Women’s Centre, is being overwhelmed by patients who are requesting hormone testing, hormone profiling and prescriptions for compounded bioidentical hormone therapy products. These women have been exposed to a marketing campaign that has no scientific basis, which leads them to believe that traditional products are unsafe, and different than the compounded bioidentical hormone therapy products. They are suspicious and angry with the medical community and pharmaceutical industry, which has lead to health care provider/patient confrontation.
These claims are false, misleading, and inflammatory and are the catalyst for a very well orchestrated marketing campaign geared directly to the consumer and more recently to physicians and other health care providers.
The Truth About Compounded Bioidentical Hormone Therapy ProductsThe following bioidentical products are produced by the pharmaceutical industry, approved and regulated by Health Canada, and available in pharmacies:
- Oral 17 B-estradiol
- Oral progesterone
- Transdermal 17 B-estradiol (gels and patches)
- Vaginal 17 B-estradiol (tablets and rings)
- Oral testosterone
- Transdermal testosterone
All bioidentical hormone therapy products currently available on the market, whether industry produced or compounded are plant derived and natural, but are “SYNTHETIC” (chemically altered). These products are derived from diosgenin, a steroid molecule found in over 90 plants, and are then synthesized into progesterone, testosterone and the three estrogens.
All bioidentical hormone products have similar risks, which are dependent on dose, route of administration, age of initiation and length of use. They can only be prescribed by a physician or nurse practitioner.
The risks of synthetic hormones referred to by the proponents of compounded bioidentical hormone therapy are based on the initial Women’s Health Initiative data in 2002, which only looked at conjugated equine estrogen and medroxy-progesterone acetate. Conjugated equine estrogen is, in fact, natural and non-synthetic. Medroxy-progesterone acetate is plant-derived and synthesized in order to be absorbed orally.
The above-mentioned bioidentical hormone therapy products were not tested in this study. The insinuation, unfortunately, is that all products produced by the pharmaceutical industry are similar, are not natural, are synthetic and carry the same risk.
A re-analysis of the WHI data with age stratification confirms the safety of starting all menopausal hormone therapies close to the onset of menopause, regardless of the source.
- The pharmaceutical industry uses the same natural, plant derived bioidentical hormone products (estradiol, estrone, progesterone and testosterone) as the compounding pharmacist to produce bioidentical oral tablets, patches, gels, creams and vaginal rings.
- Unlike the products produced by the compounding pharmacist, the pharmaceutical products undergo pharmacodynamic and safety testing to determine dosing and regimens. These products are controlled and regulated by Health Canada and labeled appropriately.
- Health Canada requires class labeling incorporating the results of the WHI. Bioidentical hormone products, whether produced by the compounding pharmacist or the pharmaceutical industry, have the same risks and benefits and should be labeled in a similar fashion and include warning language regarding adverse effects and complications. This labeling can be bypassed with compounded products. The patients therefore receive no official labeling or package inserts and warnings and assume the product is “safe”.
- Compounding pharmacists require a physician’s prescription prior to dispensing compounded products. The burden of responsibility for adverse events and outcomes is that of the prescribing doctor, not the compounding pharmacist.
Prescribing more expensive bioidentical hormone therapy products that offer no therapeutic advantage over the same products available commercially can do financial harm, as well as physical harm if not regulated and monitored carefully.
A recent report at the North American Menopause Society meeting in September, 2009 describes two women who developed cancer of the uterus while taking compounded bioidentical hormone therapy.
- Hormone testing/profiling (blood, urine, saliva) prior to the initiation or while monitoring patient progress on bioidentical hormone therapy is an ill-conceived concept. Proponents claim that this testing will enable physicians to customize and individualize hormone regimens. It is expensive and is of no clinical significance. There is no correlation between a single value or even multiple value hormone levels and the severity of symptoms.
The desired levels of hormones in peri and postmenopausal women have not been established. In addition, an individual woman’s physical comfort and emotional response may not even be related to her absolute hormone levels.
The only way to prescribe these products is to start with the lowest dose necessary and adjust according to clinical response, side effects and change in quality of life.
If women choose hormone therapy approved and regulated by Health Canada, whether bioidentical or not, early initiation is safe and has been shown to be associated with minimal risk and significant benefit. This therapy can be continued at low doses with continuing monitoring with no set time line. The same can not be said about compounded bioidentical hormone therapy.