Trump FDA Moves To Rectify One Of The ‘Biggest Errors In Modern Medicine’

WASHINGTON — The Trump administration on Monday announced moves to reverse what Food and Drug Administration (FDA) Commissioner Marty Makary has described as the “biggest error in modern medicine” — the longstanding medical advice to avoid hormone replacement in menopause.

The Department of Health and Human Services (HHS) is recommending that women talk to their doctor about using hormone replacement therapy (HRT) to treat menopausal symptoms like hot flashes and night sweats — a major reversal to a recommendation in place since 2002 to avoid it because of an alleged breast cancer risk. FDA has initiated the removal of a black box warning on HRT drugs for women and approved two new HRT drugs.

“We’re challenging outdating thinking,” said HHS Secretary Robert F. Kennedy Jr. “For the first time in a generation the FDA is standing with gold standard science and with women.”

Second Lady Usha Vance attended the press conference.

The longtime recommendation hinged on an alleged association between HRT and breast cancer announced by administrators of the Women’s Health Initiative, a multimillion-dollar National Institutes of Health study, in 2002. The media attention led prescriptions of HRT for menopausal symptoms to plummet. The study coauthors announced the finding to the press before releasing the underlying data a few days later. Third party scientists soon discovered that the alleged association did not meet standards of statistical significance. The finding was no more than a statistical blip.

Use of HRT can reduce bone fractures when taken within 10 years of the onset of menopause and reduce risk of cardiovascular disease and Alzheimer’s disease, according to studies cited by HHS. A meta analysis of 30 trials encompassing nearly 30,000 women found HRT was not associated with increased cancer mortality.

The issue has long been a priority for Makary, who has sought to undo messages he describes as harmful to a “lost generation” of women, including his own mother.

“Looking back, telling women to avoid HRT because it causes breast cancer may have been the biggest error in modern medicine,” Makary wrote in his 2024 book Blind Spots. “Women deserve an apology.”

Makary said the medical community tends to perpetuate dogma without evidence — the same tendency that persuaded Americans opioids are not addictive and that children should avoid early exposure to peanuts to prevent allergy convinced menopausal women not to take HRT, he said.

“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” said Makary.

Makary convened an expert panel at FDA campus on the HRT issue in July.

Two audience members interrupted that expert panel to take issue with the lack of a more formal FDA advisory committee meeting. Makary said on Monday that he skipped a formal advisory committee meeting because they are “bureaucratic” and “expensive.”

An FDA comprehensive review of the scientific literature followed the July panel, and FDA scientists recommended the removal of the black box warning. Makary said more evidence was forthcoming in the Journal of the American Medical Association.

Some WHI investigators conceded to Makary in his book that the findings were “borderline” or “approached” but did not meet the standards of a rigorous statistical finding. Some have expressed some regret for its wide-reaching implications.

WHI investigator JoAnne Manson, chief of the division of preventive medicine at Brigham and Women’s Hospital and a Harvard Medical School professor, said that the findings were being “misapplied” in a 2016 New England Journal of Medicine article.

The FDA approved a generic version of Premarin, A mixture of estrogens used to treat various conditions related to menopause, as well as a non-hormonal medication for treating moderate to severe vasomotor symptoms, such as hot flashes.