Buyer Beware: Physicians Pivotal in Information Battle on Menopause Hormone Therapy

Menopause and its life-altering symptoms have been garnering increasing attention, and menopause-specific telemedicine companies are proliferating. As the menopause information ecosystem gets buzzier, physicians play an important role in helping patients get the right care and filter out the noise.

“Growing awareness and cultural shifts around menopause are contributing to reduced stigma in seeking treatment for symptoms,” Jane Zhu, MD, MPP, MSHP, of Oregon Health & Science University in Portland, told MedPage Today. “A huge factor in renewed interest has been the reversal of the Women’s Health Initiative (WHI) findings on hormone therapy.”

A black box label — FDA’s most severe safety warning — was placed on menopause hormone therapy (MHT) in 2003 following the pivotal WHI trial, which found increased risks of breast cancer, coronary heart disease, stroke, and pulmonary embolism among those taking conjugated equine estrogen for menopause. Use of MHT understandably plummeted.

But in the ensuing years, researchers have learned more about MHT, including which groups and specific hormones have the most benefit and least risk.

In February, the FDA removed the boxed warnings on several MHT products as part of approved label changes, though the warnings still appear lower down in the prescribing information.

Ob/gyns were generally pleased by FDA’s label change, but there was some worry in the field about how this change came from an FDA panel on MHT rather than typical agency protocol. These panels have been criticized for sidestepping standard pathways for scientific discussions. Moreover, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, MD, MPH, mischaracterized the WHI’s findings when announcing the decision to remove the boxed warnings on MHT.

For physicians like Pamela Berens, MD, an ob/gyn at the McGovern Medical School at UTHealth Houston, who saw the pendulum swing too far after WHI, “it’s kind of been a relief to kind of come back towards the center, because patients are more open to hearing their options if they’re suffering.”

Berens told MedPage Today that while many patients have heard that the black box label was removed, they need more education on what that means for their health goals and symptom relief. She also thinks clinicians need more training on MHT, considering that clinical consensus has varied so drastically in the past few decades.

Nikki Zite, MD, MPH, an ob/gyn with the University of Tennessee Graduate School of Medicine in Knoxville, pointed to “a heightened sense of awareness” around MHT among patients, but noted that she doesn’t think clinicians are currently overprescribing the treatment.

Now that MHT’s reputation is rebounding, companies are rushing to jump on the latest health bandwagon.

“Whenever a shift in diagnosis or medical classification happens, it also opens up new market opportunities,” with telemedicine companies being one of the prevailing startup models, explained Alexander Borsa, a PhD candidate in sociomedical sciences at Columbia University in New York City. This has happened in other therapeutic areas like sexual health, attention deficit-hyperactivity disorder, and behavioral health, he noted.

Many of these companies are backed by venture capital and private equity, which Borsa said means there are “real growth expectations … to massively scale something.”

While market growth can expand access to menopause treatment, Zhu noted that “when financial incentives are tied to utilization, there’s a natural risk to overprescribe or inadequately take the individual into account.”

Whether investor-driven healthcare markets overprescribe or prescribe at higher rates is an ongoing research topic, Borsa pointed out.

“I think, as with any field, this is one that needs to be closely monitored to make sure these platforms are following clinical guidelines so that expanding access doesn’t come at a cost of appropriate care,” Zhu said.

In addition to menopause telemedicine platforms, Zite said she’s also seen a big uptick in companies touting alternative treatments, like supplements and saliva tests.

“Sometimes I feel like those are less studied options and kind of preying on someone who is vulnerable or suffering,” she said, noting that these alternatives often weaponize residual fear of MHT and hormones in general in their marketing.

“A lot of patients are suffering unnecessarily,” Zite added.

Rather than a gold rush, Berens said she’d describe the current menopause care environment as “buyer beware.” Any medical practice where the patient feels rushed, not listened to, or like they’re not getting their money’s worth should raise alarm bells.

“What I care about is your symptoms. I don’t care about your saliva,” Berens said, arguing that good care for menopause requires a longer conversation, not just a questionnaire.

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