The US Food and Drug Administration has made a controversial decision to remove stringent black-box warnings from estrogen-based menopause medications, bypassing standard regulatory procedures and drawing sharp criticism from medical experts.
Scientific Process Under Scrutiny
FDA commissioner Marty Makary announced the move last week, positioning it as a medical breakthrough that could transform women's healthcare. However, menopause specialists have raised serious concerns about both the scientific basis for the decision and the unusual process behind it.
This marks the first time the FDA has relied on a closed roundtable panel rather than its traditional public advisory committee process for regulatory decision-making, according to regulatory publication Pink Sheet.
Experts Challenge Health Benefit Claims
While hormone therapy effectively treats menopause symptoms like hot flashes, insomnia and joint pain, health officials made broader claims that alarmed researchers. Makary described it as a life-changing, even life-saving treatment that could improve population health outcomes for women.
Other officials went further. Robert F Kennedy Jr, secretary of Health and Human Services, claimed hormone therapy extends lives by up to 10 years, while Alicia Jackson of Evernow called estrogen one of the most effective longevity interventions for women.
Yet researchers say there's no evidence supporting these wider benefits. To make that blanket statement that every woman should take this to prevent heart disease – it's not true, said Dr Lauren Streicher of Northwestern University.
Distinguishing Between Different Therapies
Experts emphasize crucial distinctions between different types of hormone therapy. Local vaginal estrogen products for treating dryness and urinary symptoms are considered very safe and never should have carried the warning, according to Dr Streicher.
However, systemic estrogen is more complex. Oral estrogen increases blood clot risk while transdermal patches don't, and synthetic progesterone carries a small increased breast cancer risk. These medications aren't suitable for everyone, particularly those with a history of breast or uterine cancer.
Dementia Prevention Claims Questioned
Professor Pauline Maki, a leading researcher on menopause and dementia, expressed particular concern about claims regarding cognitive benefits. Her research initially suggested hormone therapy might help memory in women with symptoms, but larger randomized trials showed different results.
Far from showing benefit, it actually showed a trend toward harm, Professor Maki revealed. Three other major trials reached similar conclusions, yet health officials selectively cited a smaller study while ignoring this broader evidence.
The decision removes a warning from 2003 about cardiovascular disease, breast cancer and dementia risks. While appropriate for local estrogen products, experts say systemic estrogen requires more nuanced consideration.
Dr Streicher, who withdrew from the FDA panel, described the process as unscientific and agenda-driven. They handpick the people who they know are going to say what they want them to say, she claimed.
The controversy raises broader concerns about regulatory integrity and scientific process in drug approvals, with potential implications for other medications currently under review.
