Menopause is not a disease and does not increase the risk of any disease, but many commercial interests stand to profit from medicalizing the menopause transition. On this page you'll find unbiased resources on menopause. PharmedOut encourages everyone seeking information on menopause to trust only industry-free sources of information.

Have suggestions for additional resources? Drop us a line at pharmedout@gmail.com and let us know what we should add!

• Patricia Bencivenga MS, Adriane Fugh-Berman MD, and Anthony Scialli MD published “Vaginal estrogen and the prevention of recurrent urinary tract infection in postmenopausal women: a systematic review and meta-analysis of randomized controlled trials” in the June 2026 issue of Fertility and Sterility (F&S) Reviews.

• Patricia Bencivenga MS, Adriane Fugh-Berman MD, Natalie Fort MS, and Anthony Scialli MD published “The effects of menopausal hormone therapy on cardiovascular disease, cancer, cognition and depression in younger women: A systematic review” in the Journal of the Royal Society of Medicine (JSRM) Open on June 29, 2026. 

• PharmedOut submitted comments to the Agency for Healthcare Research and Quality's systematic review "Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women" on May 13, 2026. Our comment can be viewed and downloaded here. 

• Adriane Fugh-Berman MD and Patricia Bencivenga MS published "The perimenopause movement sells women the lie that they are ruled by their hormones" in STAT News on March 26, 2026. 

• Adriane Fugh-Berman MD and Patricia Bencivenga MS published "The 30-year itch: Hormone promotion is back with a vengeance" in STAT News on January 8, 2026. 

• Over 75 clinicians and researchers signed on to our letter "No Labeling Changes without an Advisory Committee Meeting" urging the FDA to convene an Advisory Committee meeting to assess potential long-term benefits and harms before making any labeling changes to hormone products on August 4, 2025. 

• Dr. Fugh-Berman and Dr. Barbara Mintzes summarize the evidence on menopausal hormone therapy in, "Menopausal Hormone Therapy: Limited Benefits, Significant Harms," an editorial in American Family Physician on July 15, 2025. 

• PharmedOut sent a letter to the FDA to support maintaining current warnings on hormone products, including vaginal estrogens, until adequate studies support a change on July 14, 2025. 

• Dr. Barbara Mintzes and Dr. Adriane Fugh Berman recently published an article, "Does menopause hormone therapy prevent Alzheimer’s disease and dementia?" in the BMJ’s Drugs and Therapeutics Bulletin where they dissect an error-filled review. They write that there is no evidence that estrogen prevents dementia and that estrogen-progestin drugs actually increase risk. The article, published on November 28, 2024, is linked here.

• PharmedOut sent a letter to the Federation of State Medical Boards on November 8, 2024 demanding removal of CME credits from a menopause documentary rife with misinformation. Signed by 16 researchers, clinicians and women's health experts, the letter counters false and dangerous statements made in a documentary on menopause and hormone therapy that was accredited by the FSMB. Read coverage by STAT News here.

• Her Turn (WORT, Madison, Wisconsin) radio show: Dr. Adriane Fugh-Berman was interviewed by Arlene Zaucha for the Her Turn (WORT, Madison, Wisconsin) radio show on misperceptions about menopause on December 10, 2023. The segment can be listened to here. 

WASHINGTON, D.C., February 13, 2026 — PharmedOut, a project at Georgetown University Medical Center that studies how pharmaceutical marketing influences medicine, today warned that the U.S. Food and Drug Administration’s decision to remove boxed warnings from menopausal hormone therapy (MHT) labels puts women at risk by making serious harms less visible to patients and clinicians.

“The science hasn’t changed,” said Adriane Fugh-Berman, MD, professor of pharmacology and director of PharmedOut. “These warnings were added because large randomized trials showed real harms. Removing a boxed warning doesn’t make a drug safer — it just makes the risks easier to overlook.”

The decision comes amid expanding commercial investment in menopause-related care, including telehealth platforms and consumer health services promoting hormone therapy, as well as increasing promotion through social media and other consumer-directed channels. PharmedOut said that in this environment, clear communication about benefits and harms is especially important.

Menopausal hormone therapy is an effective treatment for hot flashes and vaginal dryness. But major randomized trials, including the federally funded Women’s Health Initiative (WHI), found increased risks of breast cancer, stroke, blood clots, gallbladder disease, and dementia with systemic hormone therapy.

One ancillary study of the WHI, the Women’s Health Initiative Memory Study (WHIMS), found that combined estrogen–progestin therapy more than doubled the risk of probable dementia in women aged 65 and older. Estrogen-alone also had adverse cognitive effects. These findings contributed to the boxed warnings that have appeared on hormone therapy labels for more than two decades. No new evidence supports ignoring the risks that led to boxed warnings in the first place.

PharmedOut noted that while the boxed warnings related to cognition, cardiovascular disease and breast cancer are being removed, the information on risks, including language describing the WHI and WHIMS, remains on the labels under Warnings and Precautions, as well as Clinical Studies.

“Women deserve to understand why those warnings were highlighted,” said Fugh-Berman. “When risk information becomes less prominent, it can create the impression that risks have been resolved. They haven’t.”

The FDA finalized the labeling change without convening a formal advisory committee or public testimony, and PharmedOut noted that no new randomized controlled trial evidence has emerged that would materially change the balance of risks and benefits established by prior studies.

PharmedOut also noted that even small increases in risk can have large population-level consequences, especially if use expands substantially. Changes in regulatory emphasis influence prescribing patterns and patient expectations.

“Hormone therapy has an important role for women with severe menopausal symptoms,” said Fugh-Berman. “But regulatory decisions should help women make informed choices, not reassure them that a therapy is safer than the evidence shows.”

FDA’s Hormone Decision Rewrites Science and Misleads the Public
PharmedOut director warns new FDA leadership is echoing the glowing language once crafted by pharmaceutical marketers

WASHINGTON, D.C., November 11, 2025 — The FDA’s decision to remove the black-box warning from menopausal hormone therapy (MHT) is being called a dangerous distortion of science by experts who say the agency is now echoing the glowing language once crafted by pharmaceutical marketers.

“The science hasn’t changed—just the people in charge,” said Adriane Fugh-Berman, MD, director of PharmedOut, an initiative at Georgetown University Medical Center that studies how pharmaceutical marketing influences medicine. “The Women’s Health Initiative remains the largest and most rigorous study on hormone therapy, and it found clear increases in breast cancer, stroke, blood clots, gallbladder disease, and dementia in older women. Those risks are still there. Pretending harms don’t exist doesn’t make them disappear.”

The announcement was led by FDA Commissioner Marty Makary, MD and Alicia Jackson, a new Health and Human Services appointee who previously co-founded Evernow, a telehealth company providing virtual menopause care and prescribing hormone therapy online. Evernow raised $28.5 million in 2022 with the help of venture capital firms, securing celebrity investments from Gwyneth Paltrow and Cameron Diaz, before Jackson joined HHS.

The FDA did not convene an advisory committee to evaluate data. Instead, Makary convened an unconventional group of hormone promoters, many with conflicts of interest, all of whom advised lifting the black-box warning for vaginal estrogen, used locally for dryness and discomfort. On November 10th, the FDA announced label changes to systemic hormone therapy—formulations linked to serious harm in the Women’s Health Initiative (WHI).

The WHI, which followed more than 27,000 postmenopausal women, found that combined estrogen-progestin therapy increased the risk of invasive breast cancer, stroke, pulmonary embolism, gallbladder disease, and probable dementia among women over 65. Estrogen-only therapy increased the risk of stroke, ovarian cancer, and deaths from ovarian cancer. Neither regimen reduced the overall risk of heart disease or improved survival. While some benefits were seen—including reductions in hip fractures and a modest reduction in diabetes—the harms far outweighed any gains.

“These findings led to the black-box warning in the first place,” said Fugh-Berman. “Hormone therapy can relieve hot flashes and vaginal dryness, but it should never be sold as a path to disease prevention or longevity. That’s what the science shows.”

In a press conference on Monday, Secretary Kennedy praised the FDA’s move as a recommitment to evidence-based medicine, claiming that hormone therapy reduces risks of heart disease, Alzheimer’s, fractures, and mortality by up to 50 percent. Makary went even further: “HRT has saved marriages, rescued women from depression, prevented children from going without a mother,” he said.

Those claims are unfounded and contradict findings from multiple randomized controlled trials of hormones. Critics say the FDA’s tone sounds more like promotion than regulation. “It’s highly unusual for the agency to glowingly endorse a therapy,” said Fugh-Berman. “The FDA’s role is to inform the public about risks and benefits—not to reassure women that a controversial drug is safe.”

PharmedOut and other public-health advocates warn that the move reflects a broader trend in U.S. healthcare: public-interest oversight is fading while corporate and influencer messaging grows louder. “The black-box removal gives the false impression that the risks have disappeared,” Fugh-Berman said. “They haven’t—and women deserve accurate information, not hype.”

FDA Commissioner Makary has held another highly biased panel of hormone promoters, this time aimed at testosterone for men. Many presenters were clinicians expressing non-evidence-based opinions. This was not an advisory committee meeting, and there was no real discussion of data. Those who mentioned data presented misleading information on benefits and omitted talking about most proven harms.

Panelists claimed that testosterone would prevent cardiovascular disease, diabetes, and osteoporosis, despite a stunning lack of evidence in support of these claims. 

Panelists noted that low testosterone was associated with obesity, diabetes and cardiovascular disease with no acknowledgment that the direction of causation may be reversed (in other words, these conditions may decrease testosterone levels, not the other way around.)

TRAVERSE, a large, 2-year randomized controlled trial that was mentioned by several panelists, was reassuring about cardiovascular risks in a highly selected, carefully monitored population of men who received transdermal testosterone gel bringing their testosterone levels only to normal levels. In TRAVERSE, no cardiovascular benefit was found. In addition, testosterone did not prevent progression from prediabetes to diabetes, and did not improve blood sugar in diabetics. Other studies have found an increase in cardiovascular events. These data need to be analyzed as a whole.

TRAVERSE found risks of testosterone that were not mentioned by any panelist. Testosterone increased atrial fibrillation, nonfatal heart arrhythmias and kidney injury, and increased blood pressure and PSA. Cautions about this trial have been previously raised, including in an editorial accompanying the publication.

Despite claims that testosterone helps bone health (there are studies that have found that testosterone increases bone density), TRAVERSE showed a significant increase in fractures. Bone density can be increased without strengthening bone).

Testosterone levels vary daily, weekly and seasonally, and effects on common symptoms are mixed. These sham “expert” panels, made up of people selected because they uphold Commissioner Makary’s personally held opinions on hormones, are a shame. The FDA can no longer be trusted to make decisions based on best evidence.