Here’s why we think a ban is coming. Action Alert!
A National Academies of Sciences, Engineering, and Medicine (NASEM) committee recently released a report regarding compounded pain creams. The report makes clear that, like the FDA, NASEM does not seem to understand the purpose of pharmacy compounding, which is a dire concern as we await another NASEM report assessing the “clinical utility” of compounded bioidentical hormones. We fear that the upcoming NASEM report will give the FDA cover to ban compounded bioidentical hormones like estriol. We must make the FDA and NASEM listen to consumers who rely on these medicines.
The NASEM report’s conclusion demonstrates that NASEM, like the FDA, doesn’t understand compounding:
There is limited evidence to support the use of compounded topical pain creams to treat pain conditions in the general adult population. The few APIs [active pharmaceutical ingredients] that show potential effectiveness in compounded topical pain creams…are already available in FDA-approved topical products used to treat pain.
Please note that what NASEM regards as potentially effective excludes CBD oil and other supplements, not to mention many drugs that have not been formally approved for this use.
The NASEM committee then concluded that the “lack of evidence regarding systemic absorption of ingredients used in compounded topical pain creams gives rise to a substantial public health concern that requires “additional oversight” by the government. Our translation: all topical pain creams should be FDA-approved, which means that the producers must be willing to spend billions of dollars to gain approval, which will in turn mean that only patentable drugs will be available.
The existence of FDA-approved versions of medicines used by compounding pharmacies is not relevant to the need for compounded medications. Compounding pharmacies make customized, natural medicines for patients for whom it is difficult to swallow a pill (the elderly, children, and patients with disabilities, for example), as well as for patients with allergies, sensitivities to environmental contaminants and preservatives, or who require doses or delivery systems different than those of commercially available products. The whole point is that many patients, for a variety of reasons, cannot take FDA-approved versions of a medicine, so they need access to different versions of those medicines from compounding pharmacies to stay healthy.
What most concerns us is the fact that the report reads as if it was produced by the FDA, which has demonstrated almost nothing but antipathy towards pharmacy compounding. The fact that NASEM is apparently ignorant of the important role compounded medicines play in patient health does not bode well for the review of estriol and other compounded bioidentical hormones. A NASEM report finding that compounded hormones are unnecessary because there are FDA-approved hormones on the market would give the FDA plenty of cover to issue a ban on these vital medicines.
To briefly recap where we are: estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List; items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. The FDA convened a NASEM committee to study the clinical utility of treating patients with compounded bioidentical hormones; the findings of this committee will be used by the FDA to make a final decision on the fate of estriol and other compounded hormones.
The FDA’s hostility to customized bioidentical hormones has nothing to do with safety. We’ve noted that the FDA acknowledged it hadn’t received any adverse events pertaining to estriol, which shouldn’t come as any surprise: its safety profile is exceptional.
Actually, there is ample clinical evidence to suggest that bioidentical hormones are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”
Other researchers have reached similar conclusions:
Concerning cardiovascular disease, studies by the Postmenopausal Estrogen/Progestin Interventions Group (PEPI) and Gerhard et al demonstrated that natural progesterone does not negatively impact cardiovascular disease progression, unlike synthetic progestins… From the available data, BHRT may prove to be cardioprotective and not increase the risk for breast cancer [emphasis added].
There is evidence, then, that the FDA is poised to eliminate the safer alternatives in compounded bioidentical hormones: remember that there is no FDA-approved estriol product, meaning that an FDA ban on compounded estriol means patients will completely lose access to this critical hormone. We fear that the committee will not even understand the crucial difference between estriol and other estrogens. We must continue to speak out to the FDA, telling them that patients rely on these critical medicines.
Action Alert! Write to the FDA and NASEM, with a copy to Congress, telling them that patients rely on compounded bioidentical hormones like estriol. Please send your message immediately.