Dr. Marty Makary, commissioner of the Food and Drug Administration, will convene an expert panel on Thursday that he said will “set the record straight” about hormone therapy for menopause, a treatment that he champions despite mixed findings about its risks and benefits.
Although there is no public agenda, the panel is expected to discuss whether the risks have been overstated, deterring women who might benefit.
All menopause treatments containing the hormone estrogen carry a black box warning that the medication should not be used to prevent cardiovascular disease or dementia, and that it increases the risk of strokes, blood clots and probable dementia.
The label also warns of the possibility of breast cancer.
But proponents like Dr. Makary say there’s evidence that hormone therapy — approved for the treatment of symptoms like hot flashes — may prevent cognitive decline, heart disease and some cancers, in addition to conferring benefits that are not in dispute, like reducing osteoporosis-related fractures.
Dr. Makary has dismissed findings of a heightened risk of breast cancer in women who took combined estrogen and progestin, saying the research caused a “breast cancer scare” that has deterred women from getting a useful treatment.
“There’s probably no medication that improves the health outcomes of a population more than hormone replacement therapy for women who start it within 10 years of the onset of menopause,” except perhaps antibiotics, Dr. Makary said on a podcast.
“Women live longer, feel better. The benefits are overwhelming.”
Dr. Makary said on social media that he looked forward to “a robust conversation” on Thursday.
Earlier this week, an editorial in the journal American Family Physician reviewed what it called the “limited benefits” and “significant harms” of hormone therapy, and said potentially fatal outcomes like strokes and breast cancer were being trivialized.
Critics of the panel noted that its 12 members include many physicians who generally agree with Dr. Makary, and that the forum provides no opportunity for public comment.
“This is not like any other public meeting held by the F.D.A. in the past,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank in Washington. “No one in the audience is being allowed to speak. No one can ask questions.”
She expressed concern that most of the panelists have positive views of hormone therapy and that some may have financial conflicts of interest because they run exclusive practices that treat menopause with hormones.
Four panelists are members of Let’s Talk Menopause, an advocacy group supported by Pfizer, Bayer and other pharmaceutical companies that has called for removing the black box warning from local vaginal estrogen products used to treat dryness and sexual symptoms.
A fifth runs a concierge practice specializing in menopause that charges $1,450 for a first appointment. (Dr. Heather Hirsch says on her website that she takes a “no bullshit// approach” to menopause.)
Several other panelists do not accept insurance. One, Dr. Kelly Casperson, sells a $48 monthly “program membership” for adults “ready to take back their bodies, intimacy, confidence and life.”
Another panelist, Dr. Philip Sarrel, a Yale School of Medicine emeritus professor of obstetrics, gynecology and reproductive sciences and psychiatry, was quoted extensively in a recent book by Dr. Makary.
Also on the panel is Dr. JoAnn E. Manson, who was a lead investigator of the largest randomized controlled clinical trial of hormone therapy for menopause, the Women’s Health Initiative. She is attending remotely.
In an interview, Dr. Manson said that the F.D.A. might be interested in re-evaluating the black box warnings, but noted that there are “major differences” between hormone pills and a product that delivers low doses vaginally or for relief of dryness or to prevent urinary tract infections.
Observational studies suggest benefits and few risks associated with the low-dose and locally delivered hormones, but the boxed warning may discourage women from getting relief with them, she said.
There are also differences between taking estrogen orally and taking it via transdermal patches, she said. “The problem is there are no large-scale randomized trials,” she said.
Treatment should be individualized, Dr. Manson said. Oral estrogen may lower the risk of breast cancer, but it should be taken only by women who have undergone hysterectomies because it can cause uterine cancer.
Both estrogen alone and combined estrogen and progestin increase the risk of strokes.
The Women’s Health Initiative, the rigorous trial Dr. Manson worked on, was created because observational studies had linked hormone therapy to long-term health benefits for women. But the branch of the trial studying combined estrogen and progesterone was halted abruptly in 2002 because of signs of an increase in breast cancer and overall health risks.
Still, the danger to individual women was very small.
Two years later, the branch studying menopausal women taking estrogen alone was halted a year early because participants were at increased risk of stroke.
There was no increase in breast cancer with estrogen alone, and the hormone lowered heart attack risk in women in their 50s, Dr. Manson said. But a related study suggested estrogen might raise the odds of cognitive impairment and dementia.
Since then, critics have raised questions about the design of the W.H.I., saying that some of the risks it documented were of borderline significance, and that women who wanted to reap the benefits of hormone treatment should initiate it soon after the onset of menopause.
New products with different hormone formulations have also come on the market since then. Some physicians believe the topical products are safer, but they were not tested in the W.H.I. because they were not available or widely in use at the time.
Conjugated estrogen and combined estrogen and progestin taken orally were tested because “those were the most common formulations that were being used when the W.H.I. was designed in the early 1990s, and those were the formulations that were showing many benefits in the observational studies,” Dr. Manson said.
Roni Caryn Rabin is a Times health reporter focused on maternal and child health, racial and economic disparities in health care, and the influence of money on medicine.
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