Food and Drug Administration Commissioner Marty Makary announced on Monday that his agency is deregulating hormone replacement therapies for menopause patients by calling for manufacturers to remove black box warnings from their products.
Black box warnings are the highest level of caution that the FDA requires for certain potentially dangerous products. Makary, at a press conference Monday, cited several studies touting the benefits of hormone replacement therapy and demonstrating a lack of correlation between HRT and dangerous outcomes such as breast cancer.
He also said that the symptoms of menopause have been drastically understated by the medical profession.
“A male-dominated medical profession, let’s be honest, has minimized the symptoms of menopause, and as a result, women’s health issues have not received the attention that they deserve,” Makary said at the press conference.
HRT for menopause consists of estrogen and progesterone, or solely estrogen for women who have undergone a hysterectomy.
Evidence suggests that HRT alleviates the short-term symptoms of menopause, from hot flashes and night sweats to weight gain. It can also have significant long-term benefits, including slowing cognitive decline and preventing osteoporosis, the leading cause of disability and death in older women. Studies have also suggested that HRT for menopause can increase a woman’s life by an average of 10 years.
Makary said that menopause symptoms occur in 80% of women, which can have long-term effects ranging from osteoporosis, heart disease, and depression.
“They last on average eight years, and for many women, they are severe, even debilitating: mood swings, night sweats, weight gain, hot flashes, divorce,” said Makary.
Makary wrote in a Wall Street Journal op-ed on Monday that, in his medical professional opinion, the “demonization of hormone replacement therapy for perimenopausal women and the underappreciation of its health benefits ranks among the greatest mistakes of modern medicine.”
The FDA began reevaluating estrogen and progesterone therapies for menopause in July with a panel discussion on the risks and benefits of HRT, in particular the risks of breast and uterine cancer, as well as cardiovascular risks.
Makary said that internal reviewers after the July panel did “an incredible comprehensive review of the literature” to produce the recommendations.
The association between HRT and cancer became what Makary characterized in his op-ed as “groupthink” in 2002, when evidence from the Women’s Health Initiative found a correlation between nonfatal breast cancer and women receiving HRT treatment. Eventually, this led to the FDA putting a black box warning on HRT menopause treatments in 2003.
Makary referenced other issues of medical group-think, such as the failed guidance about infant and toddler exposure to peanuts and the development of peanut allergies later in life.
“Tragically for women, 50 million women since that study 23 years ago have been denied, or never offered, or talked out of the life-changing, life-saving benefits of hormone replacement therapy,” Makary said.
Some HRT formulations, however, carry a higher risk of cancer than others, according to some OB-GYNs who have expressed skepticism about the FDA’s recent moves. In particular, low-dose vaginal estrogen treatments carry a lower risk than systemic estrogen.
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Proponents of the black box warning argue that the label sparks important conversations about risk-benefit between patient and provider, but Makary and those supportive of liberating HRT contend that the label does more harm than good by discouraging primary care providers from providing the treatment to patients.
When asked about when women should begin HRT during the perimenopausal period, before the onset of menopause, Makary said that patients should speak with their doctors to monitor their estrogen levels for the best time to start therapy.
“We want people to talk to their doctors, and we want doctors to have the right information, and part of that means removing these scary black box warnings and putting the nuanced discussion in the package insert of the medications,” said Makary.
Makary also announced that FDA approved two new HRT therapies: a new combination estrogen and progesterone product and one symptom-specific medication.
