FDA commissioner stirs debate over hormone therapy for menopause

A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat menopause.   

The 12-person panel encouraged the use of the treatment late last week and called for the removal of the Food and Drug Administration’s “black box” warning label on hormone treatments.   

“I am begging the FDA, and all of us are begging, please remove the black box label,” said  JoAnn Pinkerton, a panelist and professor of obstetrics and gynecology and division direct of midlife health at the University of Virginia Health System. She specifically referred to low-dose vaginal estrogen therapies. “Please stop harming women.”    

Women’s health experts have long had mixed thoughts on menopause hormone therapy, with some arguing that the side effects outlined in the Women’s Health Initiative were overblown while others still believe the treatment poses serious long-term health risks.  

“Menopausal hormone therapy is effective for vasomotor symptoms and vaginal dryness, but those are the only proven symptomatic benefits,” Adriane Fugh-Berman, a professor of pharmacology at Georgetown University Medical Center, and Barbara Mintzes, a professor of pharmaceutical policy at the University of Sydney wrote in an editorial about the panel.   

“Serious harms, including stroke, pulmonary embolism, gallbladder disease, and increased breast cancer risk are trivialized or ignored in current narratives.”  

Many health care providers stopped prescribing hormone therapy to treat menopause symptoms after a large long-term study called the Women’s Health Initiative (WHI) came out in 2002.   

The randomized controlled trial, looked at the impacts of estrogen use to treat menopause symptoms on more than 10,000 women in the 1990s and the impacts of using both estrogen and a progestin hormone on more than 16,000 women.   

Both arms of the study were stopped when researchers found that the estrogen-progestin regimen increased the risk of invasive breast cancer, pulmonary embolism and stroke, while estrogen-only increased the risk of stroke.   

Since then, treatments for the condition that include estrogen come with a boxed warning stating that they come with an increased risk for stroke, deep vein thrombosis and dementia. Labels also state that estrogen and estrogen plus progestin therapy should not be used to treat cardiovascular disease or dementia.   

One of the issues with the study is that it examined the impacts of hormone therapy on women who were, on average, 63 years old, which is roughly a decade older than most women are when they start menopause, according to proponents of the treatment.   

Proponents, like Pinkerton, stress that it is beneficial to women if they start before age 60, or within 10 years of staring menopause.  

Other issues supporters point to are that the study only looked at one type of oral hormone therapy, and it examined the consequences of using synthetic progesterone, since natural progesterone was not approved by the FDA well after the study was conducted, according to Elizabeth Poyner, head of the Atria Health and Research Institute.   

“Synthetic progestins we know are associated with an elevated risk of breast cancer,” she said. “They are associated with an elevated risk of breast cancer in birth control pills, maybe even with IUDs, but certainly in hormone replacement therapy.”  

Some authors of the WHI published a review in JAMA last May stating that there are benefits to menopausal hormone therapy for some women.   

In the review, researchers note that hormone therapy is effective for treating some “moderate to severe” early menopause symptoms like hot flashes and night sweats. Those benefits support the “initiation of hormone therapy before age 60 years for women without contraindications to hormone therapy.”   

The FDA panel was filled with supporters for menopause hormone therapy who emphasized observational studies.   

Some women’s health advocates critical of the treatment sat in the audience of last week’s panel, according to The New York Times. When asked by an audience member if there would be time for public comment, FDA Commissioner Marty Makary said that comments took time, and he wanted to act quickly, the outlet added.   

Makary has had a special interest in menopause hormone therapy, which he mentions in his book “Blind Spots” as an example of how conventional thinking in health care is hurting Americans.   

Makary did not say if the FDA planned to change the boxed warning on menopause hormone therapies. A spokesperson for the Department of Health and Human Services, which oversees the FDA, declined to comment on any future changes to the treatment’s labeling.