Health and Human Services Secretary Robert F. Kennedy Jr., joined by FDA Commissioner Dr. Marty Makary, at a press conference on Monday called for the removal of ‘black box’ warnings on hormone replacement therapy (HRT) products. These warnings were added in 2003 and were based on misinterpreted data. Kennedy said that the warnings were designed to ‘frighten women and to silence doctors.’ He argued that the warnings were not based on scientific evidence and that they discouraged millions of women from using HRT. Makary added that the 2002 Women’s Health Initiative study, which was originally used to justify these warnings, was ‘misrepresented and created a fear machine.’ He pointed out that the study’s findings, which linked HRT with increased breast cancer mortality, were misinterpreted and led to unnecessary concerns among doctors and patients.
Kennedy also expressed frustration with the medical establishment’s response to the initial warnings, saying that they ‘doubled down in groupthink’ rather than correcting the record. He emphasized that HRT, which includes estrogen and progesterone (or estrogen alone for women who have had a hysterectomy), is a ‘breakthrough for many women’ and can alleviate symptoms such as hot flashes, night sweats, mood swings, and weight gain. He further noted that starting HRT within 10 years of menopause can lead to long-term health benefits that even some doctors may not be familiar with.
Makary cited a 1991 UC San Diego review that found HRT may reduce fatal coronary events by about 50% and a 1996 study from the University of Southern California that found women using estrogen replacement therapy had a 35% lower risk of Alzheimer’s disease compared to nonusers. Kelly Casperson, a board-certified urologist, also praised the FDA’s decision, calling it ‘not just regulatory’ but ‘revolutionary.’ She stated that the removal of the ‘black box’ warning would help ‘correct decades of misleading guidance.’ As the FDA moves forward with the removal of these warnings, the decision is expected to have a significant impact on women’s health care and the use of HRT in the U.S.