Berliner Tageblatt - US health experts reassess hormone replacement therapy risks

HRT is taken to replace estrogen the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes, vaginal discomfort, and pain during sex.

But its use has plummeted in recent years amid concerns including a potential link to invasive breast cancer.

Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, has long advocated for HRT, saying its risks have been overstated.

"For decades, hormone replacement therapy for women -- that is estrogen or estrogen plus progesterone -- has helped women alleviate the symptoms of menopause, including hot flashes, dryness, mood swings, weight gain and poor sleep quality, to name a few," he said in a video ahead of the meeting.

He added that when initiated within a decade of the onset of the transitional period before menopause, HRT may even reduce cognitive decline, the risk of Alzheimer's, and prevent osteoporosis and cardiovascular disease.

Makary blamed the drop in HRT use on a landmark clinical trial, the Women's Health Initiative, which was halted in the early 2000s after it flagged increased risks of breast cancer and stroke. But he said subsequent studies had not replicated the findings on breast cancer.

"The many benefits of hormone therapy were ignored as it was seen as a carcinogen. Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," he said Thursday.

"Fifty million plus women have not been offered the incredible potential health benefits of hormone replacement therapy because of medical dogma," he added, including his own mother, who suffered multiple bone fractures in her older life.

Critics of the trial argue it was flawed because the participants were too far from menopause, when risks are elevated and benefits limited, and that the formulations used are now outdated.

- Label changes -

Still, the issue remains divisive within the medical community.

The FDA's own warning label for HRT -- which can be administered through various means including orally, through skin patches, or vaginally -- cites risks including endometrial cancer, breast cancer, and life-threatening blood clots.

This week, the American Family Physician journal published an editorial that found limited benefits and significant harms associated with HRT.

"Menopause is a positive life experience for many women and should not be medicalized," the authors concluded.

The nature of the FDA expert meeting is also unusual. Unlike standard practice before the Trump administration, no agenda was publicly posted.

Several of the named panelists have ties to companies offering menopause treatments or who belong to the advocacy group "Let's Talk Menopause," which receives funding from pharmaceutical companies and campaigns to revise the FDA warning label.

J.Horn--BTB