When off the shelf is off the mark
Every day, with every person you serve, you use your professional judgment, your expertise, your experience to ensure the health of your patients.
Because no two patients are the same, your judgment is critical.
By restricting compounded hormones as a treatment option for hormonal imbalance, FDA would undermine your professional judgment and interfere with your ability to practice medicine.
Talk to your patients. Talk to your representatives in Congress.
Restricting compounded hormones would limit your ability to treat your patients
Perhaps this story sounds familiar:
“After 15 years of struggling with thyroid disease and menopause, I have finally found medications that work. I tried synthetic thyroid medications before, and none of them gave me the results I get with compounded hormones. My compounded medications have improved every facet of my life. It would be a disservice to all women if these treatments were unavailable.”
And yet, that is precisely what FDA may be considering — restricting patient access to compounded hormones. Limiting your options in treating your patients.
Be aware. Raise your voice.
We are raising awareness of this critical issue with doctors, with patients, with our representatives in Congress. Because the health and well-being of millions of patients depend on it.
The kind of thorough review NASEM was expected to do... but did not
While limited in scope, a 2022 meta-analysis of patient outcomes reveals that compounded hormones provide real benefits to patients — and also found that compounded hormones pose no increased risk compared to FDA-approved products.
As part of its commission, NASEM was to review the body of patient-outcome studies for compounded hormones. NASEM chose to ignore that data, instead selecting only 13 studies to include in its report, mostly featuring hormones that are not among the most commonly prescribed. (Studies that matched their predetermined outcome?)
This report, published in Menopause, the journal of the North American Menopause Society, is exactly the kind of unbiased research that NASEM should have done but didn't.
"...compounded hormones provide real benefits to patients and finds that compounded hormones pose no increased risk copared to FDA-approved products."
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The NASEM Report
The foundation of FDA's action is deeply flawed
Physicians have been prescribing and patients have been taking compounded hormones for decades. The FDA-funded NASEM report (produced by the National Academics of Sciences, Engineering and Medicine) ignores most of the data on successful patient outcomes. It excludes the insights of both physicians and pharmacists who have extensive, patient-facing cBHT experience. The NASEM Committee only included a fraction of the available data on the topic, which shows that their report does not reflect a complete or accurate understanding of compounded hormones.
Learn more about the Flaws behind the FDA's ActionsInvest today to protect access to compounded hormones.
When FDA signaled that it might severely restrict access to compounded hormones, we launched a campaign to raise awareness among patients, doctors and, especially, members of Congress.
When you contribute to this campaign, you are protecting access to this life-changing therapy for millions of patients.
