Report Release: Estriol’s Status in Serious Danger

We need to let the FDA know that we’re watching. Action Alert! On July 1, the National Academy of Sciences, Engineering, and Medicine (NASEM) is holding a webinar to release their report on the “clinical utility” of compounded bioidentical hormone replacement therapy. We expect the FDA will use this report as ammunition to ban estriol

We need to let the FDA know that we’re watching. Action Alert!

On July 1, the National Academy of Sciences, Engineering, and Medicine (NASEM) is holding a webinar to release their report on the “clinical utility” of compounded bioidentical hormone replacement therapy. We expect the FDA will use this report as ammunition to ban estriol and other bioidentical hormones from pharmacy compounding. It is critical that consumers attend this webinar to let the FDA know that we’re watching them.

As you’ll recall, 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.

NASEM has conducted several public meetings to date on compounded bioidentical hormones. During these meetings, the FDA invited experts to present to the NASEM panel, and to us it seemed that the FDA stacked the deck against compounded bioidenticals. ANH and others had to fight to get bioidentical experts longer than five minutes to present their case. What’s also clear is that the NASEM committee members lack a fundamental understanding of how compounded BHRT is used to treat menopause, meaning that committee members are susceptible to the FDA’s bias.

A bad NASEM report would be disastrous, as the FDA will have all they need to conclude that compounded bioidentical hormones can be banned. We cannot let this happen. Estriol is particularly threatened, as there is no FDA-approved version of this critical hormone; if a ban goes through, estriol access will disappear.

Patient health and safety is at stake. A review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones. On the other hand, studies have consistently demonstrated that synthetic hormones are associated with an increased risk of breast cancer. Synthetic and animal-derived hormones have also been shown to produce negative cardiovascular effects and to negate the cardio-protective effects of estrogen.

ANH-USA is working with the natural health community to get as many concerned citizens registered for this webinar as possible to demonstrate to the FDA that we’re watching them and that this issue is critical to the health of millions of women across the United States. Left to its own, the FDA will surely finish what they started in 2008, when the agency first went after estriol. We beat them back then, and we can do so again, but only with your help. Go here to register for this (free) webinar. (Note that it asks for your organization, but you are not required to list one to join and can leave this space blank.)

More background and coverage of this issue can be found on our campaign page here.

Action Alert! Register for the NASEM webinar and demonstrate your support for compounded bioidentical hormone replacement therapy. Please register now.