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The Hill
a day ago
- Health
- The Hill
FDA commissioner stirs debate over hormone therapy for menopause
A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat menopause. The 12-person panel encouraged the use of the treatment late last week and called for the removal of the Food and Drug Administration's 'black box' warning label on hormone treatments. 'I am begging the FDA, and all of us are begging, please remove the black box label,' said JoAnn Pinkerton, a panelist and professor of obstetrics and gynecology and division direct of midlife health at the University of Virginia Health System. She specifically referred to low-dose vaginal estrogen therapies. 'Please stop harming women.' Women's health experts have long had mixed thoughts on menopause hormone therapy, with some arguing that the side effects outlined in the Women's Health Initiative were overblown while others still believe the treatment poses serious long-term health risks. 'Menopausal hormone therapy is effective for vasomotor symptoms and vaginal dryness, but those are the only proven symptomatic benefits,' Adriane Fugh-Berman, a professor of pharmacology at Georgetown University Medical Center, and Barbara Mintzes, a professor of pharmaceutical policy at the University of Sydney wrote in an editorial about the panel. 'Serious harms, including stroke, pulmonary embolism, gallbladder disease, and increased breast cancer risk are trivialized or ignored in current narratives.' Many health care providers stopped prescribing hormone therapy to treat menopause symptoms after a large long-term study called the Women's Health Initiative (WHI) came out in 2002. The randomized controlled trial, looked at the impacts of estrogen use to treat menopause symptoms on more than 10,000 women in the 1990s and the impacts of using both estrogen and a progestin hormone on more than 16,000 women. Both arms of the study were stopped when researchers found that the estrogen-progestin regimen increased the risk of invasive breast cancer, pulmonary embolism and stroke, while estrogen-only increased the risk of stroke. Since then, treatments for the condition that include estrogen come with a boxed warning stating that they come with an increased risk for stroke, deep vein thrombosis and dementia. Labels also state that estrogen and estrogen plus progestin therapy should not be used to treat cardiovascular disease or dementia. One of the issues with the study is that it examined the impacts of hormone therapy on women who were, on average, 63 years old, which is roughly a decade older than most women are when they start menopause, according to proponents of the treatment. Proponents, like Pinkerton, stress that it is beneficial to women if they start before age 60, or within 10 years of staring menopause. Other issues supporters point to are that the study only looked at one type of oral hormone therapy, and it examined the consequences of using synthetic progesterone, since natural progesterone was not approved by the FDA well after the study was conducted, according to Elizabeth Poyner, head of the Atria Health and Research Institute. 'Synthetic progestins we know are associated with an elevated risk of breast cancer,' she said. 'They are associated with an elevated risk of breast cancer in birth control pills, maybe even with IUDs, but certainly in hormone replacement therapy.' Some authors of the WHI published a review in JAMA last May stating that there are benefits to menopausal hormone therapy for some women. In the review, researchers note that hormone therapy is effective for treating some 'moderate to severe' early menopause symptoms like hot flashes and night sweats. Those benefits support the 'initiation of hormone therapy before age 60 years for women without contraindications to hormone therapy.' The FDA panel was filled with supporters for menopause hormone therapy who emphasized observational studies. Some women's health advocates critical of the treatment sat in the audience of last week's panel, according to The New York Times. When asked by an audience member if there would be time for public comment, FDA Commissioner Marty Makary said that comments took time, and he wanted to act quickly, the outlet added. Makary has had a special interest in menopause hormone therapy, which he mentions in his book 'Blind Spots' as an example of how conventional thinking in health care is hurting Americans. Makary did not say if the FDA planned to change the boxed warning on menopause hormone therapies. A spokesperson for the Department of Health and Human Services, which oversees the FDA, declined to comment on any future changes to the treatment's labeling.

The Hindu
3 days ago
- Health
- The Hindu
US may revise hormone replacement therapy warnings
US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated. 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 possible link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics." He argued that the framework that led to so-called "black box warnings" -- the strongest warning the FDA can require for prescription drugs -- "came from a different era." "Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long term health benefits," Makary added. The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections. "Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50 percent," said Vonda Wright, an orthopedic surgeon at the University of Central Florida. Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition. "Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said. The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolize glucose and a rise in protein plaque deposits. Panelists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk -- findings they say were misinterpreted. "Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age. Critics of the WHI argue it included participants well past menopause -- when risks are higher and benefits lower -- and used outdated formulations no longer common today. Label changes Still, the issue remains divisive within the medical community. HRT can be administered through various means including orally, through skin patches, or vaginally; and is given either as estrogen alone or with progesterone. The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticised the lack of dissenting voices. "This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP. "While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomised clinical trial -- the gold standard of evidence -- has found HRT beneficial for cognition or dementia prevention. She also said that after the WHI findings were released, hormone use fell globally -- and breast cancer rates dropped across registries tracking them. Several of the panelists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels.


Al-Ahram Weekly
3 days ago
- Health
- Al-Ahram Weekly
Experts to revise hormone replacement therapy warnings - Health - Life & Style
US Food and Drug Administration Commissioner Marty Makary signaled that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated. 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 possible link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics." He argued that the framework that led to so-called "black box warnings" -- the strongest warning the FDA can require for prescription drugs -- "came from a different era." "Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long term health benefits," Makary added. The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections. "Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50 percent," said Vonda Wright, an orthopedic surgeon at the University of Central Florida. Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition. "Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said. The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolize glucose and a rise in protein plaque deposits. Panelists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk -- findings they say were misinterpreted. "Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age. Critics of the WHI argue it included participants well past menopause -- when risks are higher and benefits lower -- and used outdated formulations no longer common today. Still, the issue remains divisive within the medical community. HRT can be administered through various means including orally, through skin patches, or vaginally; and is given either as estrogen alone or with progesterone. The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticized the lack of dissenting voices. "This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP. "While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomized clinical trial -- the gold standard of evidence -- has found HRT beneficial for cognition or dementia prevention. She also said that after the WHI findings were released, hormone use fell globally -- and breast cancer rates dropped across registries tracking them. Several of the panelists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels. Follow us on: Facebook Instagram Whatsapp Short link:


eNCA
5 days ago
- Health
- eNCA
US may revise hormone replacement therapy warnings
WASHINGTON - US Food and Drug Administration Commissioner Marty Makary signalled that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated. 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 possible link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics." He argued that the framework that led to so-called "black box warnings" -- the strongest warning the FDA can require for prescription drugs -- "came from a different era." "Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long-term health benefits," Makary added. The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections. "Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50 percent," said Vonda Wright, an orthopaedic surgeon at the University of Central Florida. Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition. "Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said. The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolise glucose and a rise in protein plaque deposits. Panellists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk -- findings they say were misinterpreted. "Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age. Critics of the WHI argue it included participants well past menopause -- when risks are higher and benefits lower -- and used outdated formulations no longer common today. - Label changes - Still, the issue remains divisive within the medical community. HRT can be administered through various means and is given either as estrogen alone or with progesterone. The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticized the lack of dissenting voices. "This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP. "While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomised clinical trial -- the gold standard of evidence -- has found HRT beneficial for cognition or dementia prevention. She also said that after the WHI findings were released, hormone use fell globally -- and breast cancer rates dropped across registries tracking them. Several of the panellists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels.


Axios
5 days ago
- Health
- Axios
FDA panel backs menopausal hormone therapy
An Food and Drug Administration expert panel on Thursday endorsed removing the "black box" warning on hormone treatments for menopause that critics say have discouraged women for decades from using the pills and creams. Why it matters: The meeting highlighted an area of particular interest for FDA commissioner Marty Makary, who cited warnings about hormone therapy in his book "Blind Spots" as an example of medical groupthink that caused unnecessary harm. Driving the news: The 12-member panel of mostly like-minded physicians focused on the impacts of the warnings — the strongest the FDA can give a prescription drug — in stalling uptake of the therapies. While the panel didn't take a vote and has no authority to change policy, the sentiment expressed could open the door to a labeling change. The big picture: There's been increased attention to the once-taboo topic of menopause in recent years. Many providers stopped prescribing hormone therapy following research from the Women's Health Initiative in 2002 that found it increased a woman's risk of heart disease and breast cancer. Since the following year, all hormone therapies for menopause have carried warnings citing increased risk of cardiovascular events, some cancers and dementia. In recent years, more women's health experts called for that research to be put into context. They've argued that risks were overstated and the data was weighted toward women 60 and older while the average age of a menopausal woman is 51. The original study's authors wrote in JAMA last year that the benefits of hormone therapy outweigh the risks in many menopausal women. Between the lines: During the meeting Thursday, several experts highlighted benefits women with menopause could reap from estrogen treatments when it came to reducing their risk of fatal heart attacks or bone fractures. In particular, they homed in on the differences in risk presented by transdermal vaginal estrogen creams and gels versus pills. The Menopause Society and American College of Obstetricians and Gynecologists have both called for the removal of the black box warning on vaginal estrogen. "Vaginal or local estrogen is categorically safe for all women, period. Because it does not travel systemically there, again, are no increased risks of heart attacks, clots or strokes, and the black box warning is wrong" said Heather Hirsch, an internist who served on the panel. She called systemic hormone therapy warnings "broad and poorly defined." Yes, but: Thursday's meeting still irked critics who said the panel is stacked with experts to support a predetermined conclusion and could influence FDA policy without public comment. The panel itself had several financial incentives to support the wider adoption of hormone therapy, with several providers who consult for pharmaceutical companies or who made money from prescribing the medications, the New York Times reported. "The claim that the FDA's expert advisory process is 'one-sided' or politically driven is insulting to the independent scientists, clinicians, and researchers who dedicate their expertise to these panels," an HHS spokesperson said in a statement. The panelists are largely relying on observational studies, which can put undue weight on the benefits of the therapy, said Adriane Fugh-Berman, a Georgetown University professor of pharmacology who wrote a critique of the panel Thursday in American Family Physician. "It is a reasonable treatment for severe menopausal symptoms ... as long as women are actually informed of possible harms," she told Axios. The bottom line: While use of hormone therapy for menopause has been limited by the black box warnings, its popularity is growing, driven by women's health providers and businesses promoting its use.