The FDA is planning to ban compounded bioidentical hormones (cBHRT). They have made the announcement just a few hours after the National Academy of Sciences, Engineering and Medicine (NASEM) released their own report citing the “clinical utility” of cBHRT. Because this report ultimately views the use of cBHRT as a public health concern, the FDA will be quick to ban these medicines that are critical for many individuals across the country. It is important that we take a stand and mobilize as a strong grassroots response to eliminate this threat and save our access to estriol and other compounded hormones.
The FDA has hung onto this false conclusion of the report that it commissioned, and it is a direct threat to the use of estriol and compounded bioidentical hormones’ future. The FDA has cited that there is a lack of high-quality clinical evidence and minimal oversight of cBHRT, NASEM came to the conclusion that its widespread use is of concern.
But, this claim has no factual basis. A review of clinical literature concluded that bioidentical hormones are associated with lower risks, which include the risk of breast cancer and cardiovascular disease. And these are even more effective than synthetic or animal-derived hormones. What seems to be happening here is an attempt to create a drug company monopoly over compounding hormones. As a result, women may not be able to get ahold of estriol at all, even though estriol protects against cancer.
The conclusion of this report deals a blow to the future of patient access to cBHRT but this comes as no surprise as the FDA made a case against cBHRT during the process of gathering information. So, the recommendations and conclusions of the report mirror the FDA’s interests.
In particular, the committee’s recommendations include restricting cBHRT use for patients with a documented allergy to specific ingredients in the FDA approved BHT products or a documented requirement to obtain a different dosage form. Plus, patient preference is not enough to justify cBHRT use, among other things.
In the report, the NASEM committee acknowledged that a lot of women expressed a distinct interest in using cBHT but that alone was not enough to justify its use. So, we expect that the FDA will also copy this sentiment. This is a clear signal that they think that they know better than women and doctors. But this is wrong and should not be allowed to stand.
The time to send a message to the FDA is now. In the past we beat the FDA when they had tried to ban estriol back in 2008, and we can do it again, but only if our community helps us by rising up and making a stand. We cannot allow the government to get in the way of women’s health.
By attacking estriol and compounded hormones, the FDA and federal government bolsters drug monopolies and undermine available options for natural health remedies. The FDA and FTC and some state attorney general’s have already begun to tell doctors that they cannot advise their patients and the public about natural prevention and treatment for COVID-19. This is an unacceptable reality.