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FDA Threatens Multiple Sclerosis Treatment

FDA Threatens Multiple Sclerosis Treatment
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Clinical trials testing estriol for the treatment of multiple sclerosis show great promise…but the FDA is threatening to ban the only way patients can access this critical medicine. Action Alert!

Estriol is one of three main estrogens produced by the body, alongside estrone and estradiol. It is often used by integrative practitioners for its benefits to menopausal women, but recent investigations show that it may be effective in the treatment of multiple sclerosis (MS). Despite these health benefits, the FDA is poised to eliminate access to estriol and other bioidentical hormones made at compounding pharmacies. We cannot let this happen.

Estriol levels skyrocket during pregnancy, and many MS patients go into remission during pregnancy. Researchers have noted estriol’s anti-inflammatory and neuroprotective properties. This has culminated in clinical trials testing estriol as a treatment for MS, and the lead researcher on this trial recently said that so far, results have been “promising.”

Many studies have shown that estriol offers many other potential health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer.

Unfortunately, such a breakthrough may become moot if the FDA goes through with a ban on estriol and other compounded bioidentical hormones. Currently there are no FDA-approved estriol products; the only way patients can get estriol is through a compounding pharmacy.

Recall that the FDA is currently in the process of determining whether to ban estriol and other hormones from being made at compounding pharmacies. After ANH and other stakeholders mounted a massive grassroots campaign pushing back against this threat, the FDA asked the National Academies of Sciences, Engineering, and Medicine (NASEM) to evaluate the “clinical utility” of treating patients with compounded bioidentical hormones like estriol. We explained previously how NASEM’s process was heavily influenced by the FDA and outrageously biased against compounded hormones. In its final report, NASEM concluded, unsurprisingly, that widespread use of compounded hormones poses a “public health concern.”

This has no factual basis at all.  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. What seems to be underway is an attempt to create drug company monopolies. The result may be that women may not be able to obtain estriol at all, even though estriol protects against cancer.

The FDA still has hurdles to overcome before a ban can be issued: the agency has to issue a proposed rulemaking to add these hormones to the Difficult to Compound List. It’s also possible that the FDA could issue a draft guidance that restricts the use of cBHRT as outlined by NASEM’s recommendations.

The time to send a clear message to Congress and the FDA is now. We beat the FDA when they tried to ban estriol in 2008, and we can beat them again, but only if the entire community rises up and holds the agency’s feet to the fire. We cannot let the federal government interfere with our health.

Action Alert! Write to Congress and the FDA urging continued access to estriol and other important compounded bioidentical hormones. Please send your message immediately.

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