The headlines read, “Experts Urge Caution with Bioidenticals – Millions have tried custom hormones.
What the article didn’t say is more telling! Millions of women are being helped by natural bioidentical hormones, whether customized prescription or Rx manufactured prescription. So we’d like to walk through the media talking points and share our perspective:
Bioidentical is a marketing term that has no medical meaning.
This is curious, as one of the pharmaceutical companies, Solvay, uses this term on its website to discuss its bioidentical progesterone capsules, Prometrium®. The term was coined to differentiate hormones that are the same molecular structure as your own endogenous or body-producing hormones versus hormones that have an additional analog, making the molecule different than what your body produces. In fact, many physicians were confusing synthetic progestin with progesterone, and a way to differentiate was necessary. This has really become more of a divisive phrase for the FDA and pharmaceutical companies to differentiate between Rx (manufactured) drugs and prescription compounded drugs, even though bioidenticals are contained in prescription manufactured drugs like Prometrium® oral progesterone and EstroGel® transdermal estrogen. So the bottom line is that bioidentical simply means a chemical match for the human body, and it comes in both manufactured (Rx) and compounded prescription forms.
Custom compounded hormones are not approved by the Federal Food and Drug Administration and have not been proven safe and effective.
Compounded prescriptions are formulated based on a physician’s written prescription and instruction. Compounding pharmacies can only use ingredients which have been sanctioned by the United States Pharmacopeia because they are safe for use as prescribed. Compounding pharmacies are governed by the State Board of Pharmacy and are authorized by the Federal Food and Drug Administration. This is how medicine was originally dispensed long before pharmaceutical manufacturing came along. To help illustrate this, estriol is listed in the United States Pharmacopeia and is not currently manufactured for use by any pharmaceutical company in the U.S. This form of estrogen has been used successfully in Europe and Asia for decades and is approved in those countries. So the only way to get this compound is through a compounding pharmacy, which is exactly the reason why the FDA has sanctioned compounding pharmacies. Compounding is typically chosen when a dose or specific route of administration is needed that is not available in Rx manufactured form.
Hormone preparations do not need to be customized for each woman: A few standard doses work for almost everyone, medical experts say. The saliva tests that some women are given to tailor formulas are of dubious value because hormone levels fluctuate widely throughout the day.
Medical experts have not heard the outcry of millions of women who are suffering on combinations which are not relieving their symptoms. It’s time that women have the option of individualized medicine based on their unique biology. For fifty years, physicians did not test hormones levels to monitor their patients on conventional HRT. Now we have innovative ways to measure hormones in the blood, saliva and urine. Each of these diagnostics provides different kinds of information. Read our article on hormone testing. If a provider is not familiar with how to use these tools, he or she would be inclined to disregard their benefit. We are in a pioneering phase of women’s hormone health and gathering more information and data points in the best interest of women when trying to establish their needs.
Many compounders use estriol, a form of estrogen not approved for sale in the United States.
The FDA took action on the use of estriol in January of 2008, stating that compounding pharmacies cannot include estriol, a main ingredient in many compounded hormone prescriptions, since the FDA has not approved any commercial drugs containing estriol. Yet estriol is a very mild estrogen. It is one of the three estrogens natural to a woman’s body, and the main estrogen during a pregnancy – the fetus is bathed in it. Estriol is primarily used in cream form for vaginal dryness and urinary problems for women in perimenopause and menopause. The FDA recognizes that individually compounded medications should be available to patients (by prescription) for “those drugs for which no FDA approved option exists.” There are no FDA approved drugs containing estriol, so it is a perfect example of where a compounded prescription would be needed in select cases.
The FDA claims that there is no safety and patient response data for estriol. In fact, there is a body of literature about this which can be accessed in the Research section on the Women in Balance website: Bioidentical hormone research. In fact, estriol has been used in Europe and Japan for years with no reported ill effects. Like many commonly prescribed drugs, estriol has a monograph from the U.S. Pharmacopeia (USP), the ingredient compendium that sets the national standards for compounding medicines.
Women need to understand there’s no rigorous evidence these preparations are any more effective or any safer than traditional hormone therapy.
The FDA must protect the public from fraudulent and misleading claims with potentially dangerous drugs and foods, and pharmacies and pharmaceutical companies making unwarranted claims of safety and efficacy should indeed be sanctioned. WIB completely supports safety when it comes to women’s health choices!
However, women have a right to choose their treatment when multiple options exist, and practitioners have a right to prescribe drugs to benefit each individual patient. In the absence of observed and documented danger of a compounded prescription, the FDA should not interfere in the doctor-patient-pharmacist relationship. There is a body of scientific literature that supports individualized treatment, and WIB consistently calls for new research with respect to bioidenticals.
At WIB, we believe women have a right to accurate, unbiased information and resources to help them through the often tumultuous transition at menopause. We encourage you to educate yourself and ask questions before using any medications or preparations. Our goal is to empower you to take charge of your health.