On Monday, US Health and Human Services Secretary Robert F. Kennedy Jr. and US Food and Drug Administration Commissioner Dr. Marty Makary announced that after 20 years, they were righting a medical wrong — what Makary has called “maybe one of the greatest screw-ups of modern medicine” — by pushing to remove the “black box” warning on hormone therapy for menopause symptoms.

By dismissing the classwide boxed warning that flagged risks of heart disease, breast cancer and potentially dementia from estrogen-containing products, the FDA expects to open access to a therapy that Makary said was so impactful, it ranks near antibiotics and vaccines.

Makary blamed the broad 22-year-old warning on flawed, misrepresented research he said became dogma and “medical groupthink” that spread fear and dismissal of women’s menopausal “mood swings, night sweats, weight gain, hot flashes, divorce.” He hailed the “profound long-term health benefits that few people, even physicians, know about.”

“HRT has saved marriages, rescued women from depression, prevented children from going without a mother,” Makary said.

Kennedy, addressing an audience that included his wife and two daughters, described how prescription pills, creams, sprays, patches and injections that deliver estrogen or a combination of estrogen and progesterone could dramatically cut a woman’s risk of heart disease and dementia and even extend life an additional decade.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr., left, and US Food and Drug Administration Commissioner Dr. Marty Makary announced the change this week. Elizabeth Frantz/Reuters

Physicians who treat women applauded parts of the decision but said they worry that the benefits of hormones might be oversold based on outdated or cherry-picked data. Some said the removal of the black box warning from all forms of hormone therapy — particularly pills, which deliver estrogen to the entire body — isn’t scientifically justified and downplays evidence of real risks of longer-term use.

They’re not miracle drugs, they say, and benefits and risks will vary from woman to woman.

“I really worry about this overwhelming embrace of hormone replacement therapy without understanding the data,” said Dr. Leslie Cho, an interventional cardiologist and director of the Cleveland Clinic’s Women’s Cardiovascular Center. Cho was the lead author of a comprehensive research review published in 2023 that detailed the risks and benefits of hormone therapy for women of various ages and health hi