Therefore,
Menopause: panel fda experts calls:
The debate has not yet been appeased in the United States. Moreover, If the National Medicine Agency. Therefore, the Food and Drug Agency (FDA), displayed wanting to reassess the balance of mormans of the Hormonal Menopause treatment (THM) with a panel of a dozen doctors and researchers at a meeting on July 17, the method is not consensus.
The gathered panel called to lift the warnings on the packaging (these black box warnings Being the highest security warnings given by the FDA on drugs for the general public). Moreover, which had been implemented in the 2000s after the publication of an American randomized study, Women’s Health Initiative (WHI). In addition, The highlighting of a ride of complications. Meanwhile, in particular breast cancer but also cardiovascular accidents, had then brutally slowed down the use of THM in the United States and elsewhere. Nevertheless, menopause: panel fda experts calls WHI had nevertheless shown that hysterectomized women taking estrogen alone had no risk of breast cancer. For example, that THM decreased the risk of myocardial infarction (IDM) for women in the fifties.
Lowphese between WHI. Furthermore, current practices
But this study is the subject of criticism: many women included were far from menopause and especially the formulations have changed (estrogens by transdermal route, micronized progesterone, dydrogesterone) with dosages lower than what they were. For example, This is how American experts call in particular to withdraw the warning from THM (stipulating an increased risk of breast. Similarly, endometrium cancer, stroke, thrombosis and possibly dementia), and in priority of low -dose vaginal treatments.
“Fifty million women did not benefit from the incredible potential benefits of hormonal treatments because of medical ideology”said Dr. Therefore, Marty Makary. Meanwhile, head of the FDA after a Bipartisan vote by the Senate in March 2025, oncologist menopause: panel fda experts calls surgeon and longtime defender of THM. “We have done more harm in the name of” Do NO HOLD “”added Dr Heather Hirsch. specializing in menopause care, according to an article in the New York Times. For its supporters, THM, in addition to relieving climatrical symptoms (heat puffs, sleep disorders, vaginal dryness, dyspareunia, etc.). could even prevent cognitive decline, cardiovascular disease and certain long-term cancers, in addition to demonstrated benefits on the reduction of osteoporotic fractures. On the condition of starting it within ten years of menopause.
and Dr Makari. e food and medication commissioner, said according to the New York Times : “When a woman begins estrogen or the association of estrogens and progesterone in the ten years, there are about 25 to 50 % reduction in the risk of IDM and deadly cardiovascular disease. Which is comparable or greater than the risk reduction menopause: panel fda experts calls by a statine ”.
If it seems legitimate to re -examine the THM, the choice of panel, selected by Dr. Makary and little diverse, questions. This is where the rub. “This panel was chosen by Dr. Makary to prove him right in public”. Cindy Pearson said, who played an active role in the financing of the WHI. For his part, Dr. Jacques Rossouw. who directed the WHI, was at the hearing but was neither heard nor invited to be part of the panel. The public could not ask any questions or intervene at the meeting.
Menopause: panel fda experts calls
In France. an update of recoles by 2026
Things are also complicated while studies advanced by the panel are observational, a lower level of evidence that randomized trials. In addition. a recent observational observational study of the American National Health Institutes (NIH) published in The Lancet menopause: panel fda experts calls Oncology confirmed a slight increase in the risk of breast cancer in the youngest (under 55) treated by estrogen + progesterone (risk reduced with estrogens alone). In this age group, the cumulative risk would be around 4.5 % in the event of combined THM, compared to 4.1 % for non-users and 3.6 % for those using estrogen alone. Admittedly. the study does not specify the type or the processing dosages and the authors call to “Personalized advice on THM”.
To the associations of patients who asked to be consulted for the label, Dr. Makary would have said that he wanted to act “quickly”. However, controversies can only calm down with a rigorous analysis of scientific data, which takes time. What benefits to THM? What to think of the risk of breast cancer with new generation THM? Additionally, What is the scientific data?
In France. French menopause: panel fda experts calls gynecologists have long defended a safer “French” THM, the latest recommendations of the study group on menopause and hormonal aging (GEMVI) and the National College of French Gynecologists and Obstetricians (CNGOF) dating from 2021. “In the most adjusted and shortest possible doses”. In her report to the government on the support of women to menopause delivered in April. MP Stéphanie Rist was worried about a form of disinformation on social networks in a general “anti-hormone” climate. In this context. the RIST mission calls on the HAS to update its recommendations on the management of menopause in a global approach (hormonal and non -hormonal treatments, lifestyle, food supplements, medical devices, routes). The health authority should make its conclusions by the end of 2025 or early 2026.
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