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The Hill
2 days 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
4 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
4 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:
South China Morning Post
5 days ago
- Health
- South China Morning Post
The anti-ageing benefits of HRT, from collagen production to better brain and heart health
Dr Sue Jamieson remembers when the famous Women's Health Initiative (WHI) study on hormone replacement therapy, or HRT, was published. 'I was in New Mexico on holiday and caught this on the news,' says Jamieson, a Hong Kong-based specialist in integrative and functional medicine. 'I was so horrified that I might be endangering my patients' health. I sent all those on hormones an email asking them to stop it.' The study, published more than 20 years ago , was hugely damning of HRT, suggesting it caused a 26 per cent increased risk of breast cancer, a 29 per cent increased risk of heart disease and a 41 per cent increased risk of stroke. Many doctors stopped prescribing it, women's fears soared , and the US Food and Drug Administration added prominent warnings to hormone therapy products to highlight the increased risks of cardiovascular events such as heart attack, stroke and blood clots, as well as breast cancer. Sue Jamieson was among the first doctors in Hong Kong to prescribe HRT. Photo: Dr Sue Jamieson The study was found to be flawed. Based on research since, and the development of bioidentical hormones – which are chemically the same as natural hormones and safer than the older synthetic oestradiol (E2), which Jamieson describes as an 'aggressive' form of oestrogen – attitudes towards HRT have evolved.
South China Morning Post
5 days ago
- Health
- South China Morning Post
The anti-ageing benefits of HRT, from collagen production to better brain and heart health
Dr Sue Jamieson remembers when the famous Women's Health Initiative (WHI) study on hormone replacement therapy, or HRT, was published. 'I was in New Mexico on holiday and caught this on the news,' says Jamieson, a Hong Kong-based specialist in integrative and functional medicine. 'I was so horrified that I might be endangering my patients' health. I sent all those on hormones an email asking them to stop it.' The study, published more than 20 years ago , was hugely damning of HRT, suggesting it caused a 26 per cent increased risk of breast cancer, a 29 per cent increased risk of heart disease and a 41 per cent increased risk of stroke. Many doctors stopped prescribing it, women's fears soared , and the US Food and Drug Administration added prominent warnings to hormone therapy products to highlight the increased risks of cardiovascular events such as heart attack, stroke and blood clots, as well as breast cancer. Sue Jamieson was among the first doctors in Hong Kong to prescribe HRT. Photo: Dr Sue Jamieson The study was found to be flawed. Based on research since, and the development of bioidentical hormones – which are chemically the same as natural hormones and safer than the older synthetic oestradiol (E2), which Jamieson describes as an 'aggressive' form of oestrogen – attitudes towards HRT have evolved.
