Here’s a rewritten version of the article, preserving all verifiable facts adn aiming for 100% uniqueness:
FDA Panel Discusses Potential Removal of Menopause Hormone Therapy Warnings
A recent panel convened by the Food and Drug Administration (FDA) explored the possibility of removing certain warnings associated with hormone therapy for menopause. This discussion marks a significant,albeit unconventional,moment in how the agency approaches such decisions.
dr. David Makary, a surgeon and panel member, expressed a desire for guidance from the assembled experts on how the FDA should proceed. However, the panel’s structure and the nature of the discussion drew criticism from some quarters.
adriane Fugh-Berman, a professor of Pharmacology at Georgetown University, characterized the event as “theater, not scientific evaluation.” She voiced skepticism regarding the removal of existing labels, emphasizing that the FDA typically employs a more stringent process for informing such changes. Fugh-Berman stated that this established process is being “undermined and distorted.” It’s noted that Fugh-Berman has previously served as a paid expert witness in legal cases against pharmaceutical companies accused of overstating the benefits of hormone therapy and it’s link to breast cancer.
Fugh-Berman suggested that a more traditional FDA decision-making pathway would involve a public comment period and the formation of an expert committee with a broader range of specialists, including epidemiologists, oncologists, and public health experts.Representatives from the FDA did not provide comments when contacted for this story,nor did they offer details on any future steps in a potential process to remove the warnings from prescriptions.
Despite the departure from typical FDA procedures, at least one obstetrician expressed enthusiasm for the increased focus on this subject. Dr. Rachel Rubin, a urologist specializing in sexual medicine and a panel member, described the FDA head’s engagement with the topic as “extraordinary” and something the medical community has long hoped for.While acknowledging that “voices were missing” and the process deviated from the FDA’s usual rigor, Rubin felt it was a valuable prospect to advocate for long-held positions.Dr. Monica Christmas, an OB-GYN, declined to comment on whether the panel’s composition or the process should have been different or more rigorous. However, she did convey concern that the growing enthusiasm for hormone therapy in managing menopause might be overshadowing the crucial risk-benefit analysis required for patient and physician decision-making. Christmas cautioned that hormone therapy is becoming “synonymous with menopause” and that women should explore other potential causes for thier symptoms before opting for hormone therapy. She observed a tendency for some to believe that hormone therapy is a universal solution for menopausal symptoms, attributing “magical or mystical benefits” to it.
The article also briefly mentions that hormone therapy can offer benefits such as a reduced risk of osteoporosis, among others.
