Compounded bioidentical hormone replacement therapy (cBHRT) is in peril. Help support a sign-on letter in Congress telling the FDA NOT to limit access to these treatments. Action Alert!
The letter, circulated by Reps. Jennifer Wexton (D-VA) and Michael Burgess (R-TX), draws attention to many of the issues with the FDA’s process we’ve discussed in our Pulse newsletter in the past, urging the FDA to enact policies that allow patients to continue using cBHRT. The 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 members of Congress to support this sign-on letter.
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, 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 partial. 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.
The Congressional letter draws attention to these issues with the NASEM report, calling on the FDA to develop policies that allow consumers to access cBHRT.
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 Congress and tell your representative to sign on to Reps. Wexton and Burgess’s letter supporting consumer access to cBHRT. Please send your message immediately.
Bio identical hormones have kept me healthy and youthful for more than 30 years after the unnecessary removal of my ovaries (by a male surgeon). It is insulting and ignorant for the government to think they know better than millions of patients and their doctors.
The bioidenticals are something many women choose to take so please do not limit the access to these compounds. Concentrate on the many pharmaceuticals that are harming people. Sincerely, Debra Johnson
I have used bioidentical hormones for almost 20 years after a complete hysterectomy. My ovaries were fine and should not have been removed. I went into meltdown after the surgery. I didn’t know what to do until I “stumbled” upon bioidentical hormones. Big Pharma has failed women with their progestin and premarin. Progestin was so harmful it was taken off the market. Please allow these natural hormones to be made available to any woman who wants to use them. Why would anyone not want someone to have a product available to them that helped them to lead a healthy and active life? It is my understanding that men use these bioidentical hormones as well.
The proposed actions to ban these type of compounded hormones is offensive and shows big Pharma’s greed and need to make money of the sicknesses and ill health of Americans. By taking away these hormones you take away our right to make our own health decisions, as opposed to being ‘sold’ on the synthetic versions, which we know cause female cancers. If these compounded hormones are not available to people it’s equal to taking away our rights as individuals to make our own informed choices about our personal health. As a health practitioner I am beyond horrified that this is even up for debate. Isn’t this America, where we have the freedom to make our own decisions about the kind of products that we choose to put in our body?!? This is ALL motivated by the FDA’s marriage to big pharma and their greed. Just like with the Opiate epidemic, the government stood by and ALLOWED this to happen, fully and knowingly, which has killed any faith that Americans have in these regulatory agencies so called ‘mission’ to protect individuals. It’s all based in profit losses to the big pharmaceutical companies which are in bed with the FDA. This is shameful and completely unacceptable.
I have used bioidenitcal progesterone for 23 years. It helped mitigate my menopausal symptoms and I continue to use it since it helps remyelinate the brain as I have a demyelinating disease called multiple sclerosis. I hope I will not lose access to this valuable and very safe hormone.
Tina
I can’t count the number of broken bones I suffered before learning from the late Dr. John Lee, MD about applying progesterone cream. It s safe, effective and inexpensive. Now my bones are healthier than ever. The formulas used for hormone replacement therapy cause side effects like stroke, cancer and brittle bone disease. Let us live in peace!