Millions of women rely on hormone replacement therapy to manage the symptoms of menopause. Hot flashes and night sweats affect two-thirds of all women as they transition into menopause, sometimes for years afterward, severely diminishing the quality of their lives. Unlike conventional hormone therapy that uses synthetic and animal-derived hormones that are different from a woman’s own hormones, bioidentical hormones are biochemically identical to those made by the ovaries during a woman’s reproductive years. Unfortunately, the Food and Drug Administration (FDA) is poised to eliminate women’s access to medications that are often safer and more effective than the alternatives.
Why It Matters
- Patients prefer them. Studies have shown that women report greater satisfaction, fewer side effects, and improved quality of life when they were switched from synthetic to bioidentical progesterone.
- Synthetic hormones are associated with increased risk of breast cancer, cardiovascular events, and stroke.
- Bioidentical hormones are associated with health benefits, including positive effects for brain health, blood pressure, and menopausal symptoms.
- Has the potential to be anti-cancer.
- Has helped patients with multiple sclerosis avoid relapses.
- Offers protective benefits for the cardiovascular system.
- Improved bone mineral density in postmenopausal women.
The Hit Job
FDA commissioned a study from the National Academies of Sciences, Engineering, and Medicine (NASEM) to assess the “clinical utility” of treating patients with compounded bioidentical hormone replacement therapy (cBHRT). NASEM issued its report on July 1, 2020.
In an announcement directly after the report’s release, the FDA highlighted NASEM’s main finding: “Given the lack of high-quality clinical evidence and minimal oversight of [compounded bioidentical hormone therapy], NASEM concluded that their wide-spread use poses a public health concern.”
Specifically, the committee’s recommendations include:
- Restricting cBHRT use to patients with a documented allergy to an ingredient in FDA approved BHT products or a documented requirement for different dosage form.
- Patient preference alone is not enough to justify cBHRT
- cBHRT doses should not exceed FDA-approved product dosages.
- The FDA’s Pharmacy Compounding Advisory Committee (PCAC) should review select hormones for the Difficult to Compound list, including estradiol, estrone, estradiol, progesterone, estriol, testosterone, and the pellet dosage form.
- The federal government and State Boards of Pharmacy should expand and improve oversight of 503A “traditional” pharmacies to ensure quality standards for every cBHRT preparation dispensed.
The findings of this report are outrageous. Of the hundreds of studies on bioidenticals, the committee, which did not include either a pharmacist or a physician with practical expertise in cBHRT, selected just 13 studies to consider. Additionally, compounded drugs are exempted from the new drug approval process by law, and yet the committee chose to use this standard in their evaluation. And while the committee concluded that cBHRT posed a “public health concern” they cited no cases of harm in reaching this determination. Now, millions of women stand to lose access to an important component in their health protocols.
How You Can Help
There’s still time, but the time to act is now. This attack on estriol and other compounded bioidentical hormones is part of a concerted campaign by federal agencies against natural medicine. And this isn’t the first instance in which the FDA has gone after hormones. The agency tried to eliminate access to estriol in 2008, but a strong grassroots response was able to defeat that effort. We need to do the same now.
Sign our petition to protect bioidentical hormones and other natural treatments from government intrusion.