FDA panel backs menopausal hormone therapy
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An Food and Drug Administration expert panel on Thursday endorsed removing the "black box" warning on hormone treatments for menopause that critics say have discouraged women for decades from using the pills and creams.
Why it matters: The meeting highlighted an area of particular interest for FDA commissioner Marty Makary, who cited warnings about hormone therapy in his book "Blind Spots" as an example of medical groupthink that caused unnecessary harm.
Driving the news: The 12-member panel of mostly like-minded physicians focused on the impacts of the warnings — the strongest the FDA can give a prescription drug — in stalling uptake of the therapies.
- While the panel didn't take a vote and has no authority to change policy, the sentiment expressed could open the door to a labeling change.
The big picture: There's been increased attention to the once-taboo topic of menopause in recent years.
- Many providers stopped prescribing hormone therapy following research from the Women's Health Initiative in 2002 that found it increased a woman's risk of heart disease and breast cancer.
- Since the following year, all hormone therapies for menopause have carried warnings citing increased risk of cardiovascular events, some cancers and dementia.
- In recent years, more women's health experts called for that research to be put into context. They've argued that risks were overstated and the data was weighted toward women 60 and older while the average age of a menopausal woman is 51.
- The original study's authors wrote in JAMA last year that the benefits of hormone therapy outweigh the risks in many menopausal women.
Between the lines: During the meeting Thursday, several experts highlighted benefits women with menopause could reap from estrogen treatments when it came to reducing their risk of fatal heart attacks or bone fractures.
- In particular, they homed in on the differences in risk presented by transdermal vaginal estrogen creams and gels versus pills.
- The Menopause Society and American College of Obstetricians and Gynecologists have both called for the removal of the black box warning on vaginal estrogen.
- "Vaginal or local estrogen is categorically safe for all women, period. Because it does not travel systemically there, again, are no increased risks of heart attacks, clots or strokes, and the black box warning is wrong" said Heather Hirsch, an internist who served on the panel.
- She called systemic hormone therapy warnings "broad and poorly defined."
Yes, but: Thursday's meeting still irked critics who said the panel is stacked with experts to support a predetermined conclusion and could influence FDA policy without public comment.
- The panel itself had several financial incentives to support the wider adoption of hormone therapy, with several providers who consult for pharmaceutical companies or who made money from prescribing the medications, the New York Times reported.
- "The claim that the FDA's expert advisory process is 'one-sided' or politically driven is insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels," an HHS spokesperson said in a statement.
The panelists are largely relying on observational studies, which can put undue weight on the benefits of the therapy, said Adriane Fugh-Berman, a Georgetown University professor of pharmacology who wrote a critique of the panel Thursday in American Family Physician.
- "It is a reasonable treatment for severe menopausal symptoms ... as long as women are actually informed of possible harms," she told Axios.
The bottom line: While use of hormone therapy for menopause has been limited by the black box warnings, its popularity is growing, driven by women's health providers and businesses promoting its use.
- Usage could jump significantly if the FDA does ultimately decided to pursue a change to these labels.
