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Hormone Replacement Therapy in Jeopardy

Hormone Replacement Therapy in Jeopardy
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The screws continue to tighten on compounded bioidentical hormone replacement therapy (cBHRT), the future of which is in peril. We need your help to support a US Senate sign-on letter telling the FDA NOT to limit access to these treatments. Action Alert!

A letter being circulated in the Senate by US Senators Tammy Baldwin (D-WI) and Roger Marshall (R-KS) urges the FDA to enact policies that allow patients to continue using compounded bioidentical hormone replacement therapy (cBHRT). These actions are necessary because FDA is threatening to ban compounded bioidentical hormones like estriol, progesterone, testosterone, and estradiol. Millions of women rely on these medicines to manage the symptoms of menopause, overcome fertility challenges, or treat other hormonal imbalances. These women need cBHRT to stay healthy and cannot, or do not want to, use the FDA-approved versions of these hormones. We must urge our Senators to support this letter.

Earlier this year we supported a House of Representatives letter led by Representatives Jennifer Wexton (D-VA) and Michael Burgess (R-TX). Thanks to your help, ANH and other stakeholders were able to get 23 other representatives to sign on to the letter, signaling their support for cBHRT. We need to generate similar success in the Senate to build momentum around this issue.

To recap how we got here: The FDA is in the process of deciding whether it will allow patients to continue to access compounded bioidentical estriol, progesterone, testosterone, and estradiol. It is clear to anyone paying attention that the FDA is seeking a ban on these medicines.

When ANH and other stakeholders organized widespread grassroots opposition to a ban on estriol and other compounded hormones, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to review the “clinical utility” of treating patients with cBHRT. The intention of this review was clear: the FDA orchestrated what would look to outsiders like an “impartial” review of cBHRT to give itself cover to ban these medicines. And right on cue, NASEM’s report found that treating patients with cBHRT was a “public health concern.”

Yet NASEM’s review was anything but impartial. Conspicuously missing from the committee was anyone with an expertise on how compounded bioidentical hormones are used to treat patients. Several members had ties to pharmaceutical companies which would benefit from compounded medicines being eliminated. The FDA was also heavily involved in the development NASEM’s final report, all but guaranteeing that it reached the “proper” conclusions. You can read our coverage of these and other biases in for more detail.

What is especially insulting about the government’s approach to cBHRT is their complete lack of concern for women’s preferences. Again and again in their report, members of the NASEM committee acknowledged that many women express a distinct preference for cBHRT, but that this wasn’t enough to justify its use. It’s a clear signal: we know better than women.

Estriol is particularly at risk; there is no FDA-approved estriol product, so a ban on the compounded medicine would mean complete loss of access. Many studies have shown that estriol offers many health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer. A ban would cause suffering for many, many women.

We must support any and all efforts to stop the FDA’s plans against cBHRT from moving forward.

Action Alert! Write to your Senators and tell them to sign on to the Senate letter headed by Sens. Baldwin and Marhsall supporting consumer access to cBHRT. Please send your message immediately.

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