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FDA is Failing Women

FDA is Failing Women
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Women coping with menopause have been ignored by mainstream medicine for years, and now the FDA is making it worse by threatening to ban estriol and other medicines that can support women’s health. Action Alert! 

A recent article in The New York Times draws attention to a number of critical issues centering on the idea that our health establishment is not properly serving the needs of women managing menopause. There is no better example of this neglect than the FDA’s treatment of compounded bioidentical hormone replacement therapy (cBHRT), an option preferred by millions of women, but which is at risk of being banned. The FDA apparently doesn’t care that many, many women rely on cBHRT to manage their health and feel like themselves again. This callous disregard for women in the interest of drug industry profits cannot be allowed to stand.

As women know, menopause is no joke. About 85 percent of women experience menopausal symptoms. These symptoms can be severe and affect daily functioning. The author describes the experiences of some of her friends:

The symptoms they experienced were varied and intrusive. Some lost hours of sleep every night, disruptions that chipped away at their mood, their energy, the vast resources of good will that it takes to parent and to partner. One friend endured weeklong stretches of menstrual bleeding so heavy that she had to miss work. Another friend was plagued by as many as 10 hot flashes a day; a third was so troubled by her flights of anger, their intensity new to her, that she sat her 12-year-old son down to explain that she was not feeling right — that there was this thing called menopause and that she was going through it. Another felt a pervasive dryness in her skin, her nails, her throat, even her eyes — as if she were slowly calcifying.

Yet when these women went to their doctors, they were told there was “no obvious recourse for these symptoms,” with some doctors waving these symptoms off as hardly worth discussing. Some doctors were uncomfortable discussing topics like lower libido and vaginal dryness. A professor of psychiatry who studies menopause and is interviewed in the article said that this ill-treatment “suggests that we have a high cultural tolerance for women’s suffering. It’s not regarded as important.”

The public health establishment is failing women. What the article doesn’t discuss is how the FDA is adding insult to injury by turning its back on the health of millions of women.

We’ve been writing for some time about the agency’s attack on estriol and other components of cBHRT. This is part of a larger effort to eliminate customized medicines from the landscape, as they compete with FDA-approved drugs which the agency prefers, since drug approval pays the FDA’s bills.

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 FDA and NASEM bemoan the lack of clinical trial data on cBHRT’s efficacy. For one, it’s impossible to run clinical trials on compounded medicines because dosages are not standardized; doses are customized to meet individual patients’ needs. Many different trials would be needed to assess the efficacy of the wide range of hormone doses given to patients, which is not financially feasible. But here’s where the insights from the NYT article come into play: might there also be a lack of data on cBHRT, and hormone therapy generally, because the medical establishment does not properly value women’s health and place enough emphasis on the need to understand and treat symptoms of menopause?

By not only casually dismissing patient preference for cBHRT but threatening to take this away as an option for women, the FDA is doing the same thing that the NYT writer describes doctors doing to women in need of treatment: dismissing their health problems with a wave of the hand and the proverbial pat on the back. And not only are women being dismissed; their healthcare options are being eliminated.

Note that 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.

Action Alert! Write to Congress and the FDA, urging them to retain consumer access to cBHRT. Please send your message immediately.

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