Context:

Dr. Marty Makary, the FDA commissioner, convened a panel to address the overstated risks of hormone therapy for menopause, a treatment he supports despite mixed findings. The panel is evaluating whether the current black box warnings on estrogen-containing menopause treatments, which caution against their use for preventing cardiovascular disease or dementia, are necessary. Proponents argue that hormone therapy offers benefits such as reduced osteoporosis-related fractures and potential prevention of cognitive decline and heart disease, while critics warn of serious risks like breast cancer and strokes. The panel has attracted criticism for its lack of public input and potential conflicts of interest among its members, many of whom have financial ties to hormone therapy pharmaceutical companies. Dr. JoAnn E. Manson, a lead investigator in the Women’s Health Initiative, highlighted the need for individualized treatment and noted differences in risks between types of hormone delivery methods, emphasizing the absence of large-scale trials for newer products.

Dive Deeper:

• Dr. Marty Makary has organized an expert panel to reassess hormone therapy for menopause, which he believes has been unfairly criticized and deterred women from benefiting due to overstated risks. He argues that hormone therapy can improve health outcomes significantly if started within 10 years of menopause onset.

• Hormone therapy for menopause carries a black box warning about increased risks of cardiovascular issues, strokes, blood clots, dementia, and breast cancer. Dr. Makary and other proponents argue that these warnings may overemphasize risks and overlook the therapy's potential benefits like reducing osteoporosis-related fractures and preventing cognitive decline.

• The panel's composition and operation have drawn criticism due to its lack of public engagement and the presence of panel members who have financial ties to hormone therapy treatments. Critics, including Diana Zuckerman from the National Center for Health Research, express concerns over potential biases influenced by these connections.

• Dr. JoAnn E. Manson, involved in the Women’s Health Initiative, stresses that hormone therapy should be personalized, acknowledging varying risks between oral estrogen and transdermal or vaginal applications. She notes the absence of large-scale trials for newer hormone delivery methods, which complicates comprehensive safety assessments.

• The Women’s Health Initiative previously halted its studies on hormone therapy due to increased risks of breast cancer and other health issues, but these findings have been questioned regarding their significance and relevance to current formulations. Observational studies have since suggested benefits, but their reliability is debated due to potential confounding factors.