Lisa Jarvis: Why can't we get hormone therapy right?
Published in Op Eds
If you’re a woman of a certain age, your social media feed is likely filled with advice on what hormones you should take. The promises made by menopause influencers about hormone therapy are expansive: easing hot flashes and night sweats for starters, but also promoting better brain and heart health, improving muscle mass and bone strength, boosting energy, and even enhancing your sex life.
What bone-tired, middle-aged woman balancing childcare, elder care and a job — while also trying to maintain some semblance of a healthy long-term partnership — wouldn’t want all that?
And yet, as women’s health influencers, participants on menopause message boards, and now the head of the U.S. Food and Drug Administration will tell you, doctors have for too long been “gatekeeping” hormone therapy. Millions of women, the narrative goes, are being deprived of something that could help them live longer and feel better.
If only the evidence supporting those claims about hormones were as strong as their conviction in them. Hormone therapy can help many women, but it’s not the panacea many advocates are promising. And while women’s health has indeed suffered from neglect, it does women a terrible disservice to overpromise on what any single therapy can do for their health.
FDA Commissioner Marty Makary has long been a proponent of expanding access to hormone therapy so that more perimenopausal and menopausal women can benefit from it. (He devotes a chapter to the topic in his most recent book, Blind Spots.) Last week, he directed the FDA to remove the black box warning labels from several forms of hormone therapy, theoretically making it easier for women in midlife and beyond to access these treatments.
A pall was cast over such treatments in 2002, when a large, long-term study — the Women’s Health Initiative — ended abruptly after researchers found hormones increased the risk of heart disease, strokes and breast cancer. Over time, it became clear that those warnings were not only overblown but also wrong: Hormone therapy did not increase the likelihood of a heart attack, and short-term use didn’t increase women’s chances of developing breast cancer. Moreover, new and safer products have emerged that minimize those already small risks.
Yet some doctors spent decades reluctant— or even refusing — to prescribe hormones to alleviate women’s symptoms. In a podcast discussion about the policy change, Makary described the 2002 pullback as “maybe one of the greatest screw ups of modern medicine.” By getting rid of the black box warnings, he said, “we are getting rid of that fear machine.”
As I’ve written, a corrective to that frustrating period is overdue. And yet by making these changes without nuance, Makary is ushering in a new, equally frustrating era — one where the pendulum swings too far toward treatment for all, regardless of their symptoms or the data, and where expectations for what the therapy can deliver are overstated.
Let’s start with the good in last week’s decision: The FDA removed the so-called black box warning on topical estrogen. Doctors have long argued that this warning mistakenly conflated the risks of systemic medicines with those of a locally applied, low-dose formulation that clinical studies have shown to be very safe. That label has discouraged its use, even though it can help prevent and treat a number of menopause-related conditions.
Doctors are less in agreement on the FDA’s decision to remove the black box warning from other forms of hormone therapy, which deliver estrogen systemically and may carry longer-term risks for some women. While it’s true that many physicians might have been overly cautious, and that the field has needed to do better by women, patients still deserve all the pertinent information when considering a new treatment.
But Makary didn’t stop at removing the labels. During a press conference announcing the labeling change, he and several menopause doctors (who have built vast social media followings — and lucrative private practices — by promoting hormones) significantly overstated the benefits of hormone therapy while minimizing its potential risks.
Research shows that hormone therapy can help relieve many of the symptoms of menopause — including hot flashes, night sweats and vaginal dryness — and can help protect against bone loss and lower the risk of developing diabetes. Yet Makary claimed it has “profound long-term health benefits that few people, even physicians, know about.” Those purported benefits, he said, include cutting their risk of heart disease by as much as half and Alzheimer’s disease by 35%, and even extending the lives of breast cancer patients.
Menopause researchers who have spent years studying the effects of hormone use were stunned by some of the unfounded claims. “They’re making menopause and hormone therapy synonymous,” says Monica Christmas, associate medical director of the Menopause Society. They’re suggesting that hormone therapy is “this magic antidote to aging and it’s not,” she says.
The hype was enough to draw Pauline Maki, director of the University of Illinois College of Medicine’s Women’s Mental Health Research Program, off the social media sidelines. In an Instagram video — one of only six posts she’s ever made — Maki walks through the results of a randomized study she conducted comparing brain function and memory in women taking hormones with those receiving a placebo. She found no difference between the groups — and neither did three larger studies conducted by other researchers in her field. “Not one of them found an improvement in cognition,” she says. “Zero, zip, zero.”
In subsequent research, Maki found that hormone therapy may improve cognition — but only in women experiencing the most severe symptoms. “They’re having these hot flashes and waking up in the middle of the night,” she says. “You don’t need me and all my decades [of research] to tell you that if you’re not sleeping well, your cognition is bad.”
A more open conversation about menopause and greater access to therapies for women who might truly benefit from them should be welcomed. But women also deserve accurate, evidence-based information so they can make informed decisions about their health. Anything short of that isn’t progress, it’s more paternalism.
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This column reflects the personal views of the author and does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.
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