FDA Decision on Menopause Hormone Therapy Draws Sharp criticism From Medical Experts
WASHINGTON – A recent decision by the Food and Drug Governance to re-evaluate decades-old warnings about menopause hormone therapy is facing backlash from leading medical professionals who claim the move is unsupported by scientific evidence and potentially harmful. The FDA’s shift, framed by officials as a challenge to “medical groupthink,” has ignited a debate over the appropriate use of hormone therapy for women experiencing menopause symptoms.
The controversy centers on the FDA’s apparent reliance on data from a limited study while disregarding larger, randomized trials demonstrating the risks associated with hormone therapy. Experts warn that the decision, championed by figures like Robert F. Kennedy Jr., risks misinforming women and undermining established medical consensus. This comes as the agency faces scrutiny over recent alterations to its website, including changes related to vaccine safety, raising concerns about the influence of unsubstantiated claims on public health messaging.
Dr. Stephanie Faubion, medical director of the north American Menopause Society, expressed strong disagreement with the FDA’s approach. “it was not only scientifically wrong, but it was offensive,” she stated. The core of the dispute lies in the FDA’s decision to downplay previous warnings about the potential risks of hormone therapy, especially concerning heart disease, stroke, and breast cancer.
According to research led by Dr.Lisa Maki,hot flashes-experienced by roughly three-quarters of menopausal women-can substantially disrupt sleep and contribute to memory issues over time. Maki’s work suggests that addressing these symptoms, whether through hormone therapy or other medications, may be key to improving cognitive function. However, she firmly believes that using hormone therapy specifically for dementia prevention “is just not based in science.”
The FDA’s decision was lauded by Kennedy, who proclaimed, “For the first time in a generation, the FDA is standing with science and standing with women.” He further claimed the agency was “restoring integrity to medicine, restoring faith in public health.” Kennedy recently attempted to link women’s use of acetaminophen (Tylenol) during pregnancy to autism, a claim widely dismissed by the medical community.
dr.Marty Makary, a surgeon and advocate for the change, characterized the decision as “challenging the paternalism of medicine,” and suggested hormone therapy “has saved marriages.” Dr. Streicher emphasized that while hormone therapy is safe and effective for managing menopause symptoms, it is not a global solution. “But do I tell every single woman who goes through menopause that she needs to be on hormone therapy? Absolutely not.”