For years, my health care providers – general practitioner and specialists – hounded me to take hormone replacement therapy, or HRT, for bone health.
For years, I resisted. In my research on HRT, I found out that taking HRT for 10 years increased your chances of getting cancer by 10 percent. That means if you took it for 30 years, it would increase your cancer risk by 30 percent.
It was pretty clear to me. I told the many care providers who berated me for not taking HRT that I didn’t want to put strong bones in my grave when I died of cancer
In 2002, researchers raised concern about HRT because a long-term study called the Women’s Health Initiative found that hormone therapy was associated with increased risk of cancer and stroke.
Then, the tables turned.
I asked my doctor after the study if I could take a bioidentical HRT. They’re processed hormones designed to mimic the hormones made by the body’s glands, which are made from plants. She said no.
On Monday, U.S. Food and Drug Administration, or FDA, announced that it’s removing the black box warning – the agency’s most serious warning – from the prescribing information of all menopause hormone treatments containing estrogen.
These treatments are approved for hot flashes, night sweats, and vaginal atrophy due to menopause and the prevention of postmenopausal osteoporosis.
The prescribing information for these drugs will be updated to remove boxed warnings about the increased risk of blood clots and stroke, probable dementia, and breast cancer, as well as the recommendation that these treatments should be used at the lowest dose and for the shortest duration consistent with treatment goals and risks, according to Trump’s newly appointed FDA Commissioner Martin Makary, M.D..
Makary told a reporter in a National Public Radio interview that the FDA created an advisory panel and asked for comments on HRT. He almost gleefully told the reporter how the agency reduced the regulatory process.
He did say in the interview that there are some women who shouldn’t take HRT: those who have had breast cancer or a heart attack and older women who didn’t begin taking HRT early in menopause.
Systemic hormone therapy, pills and patches, also isn’t generally recommended for people with blood clots, endometrial cancer, stroke, or liver disease, according to the American College of Obstetrics and Gynecology, or ACOG
Previously, Public Citizen and other consumer and health groups, urged the FDA to consider labeling changes for HRT only after undertaking an impartial rigorous assessment of all available evidence, convening an advisory committee of independent experts, and addressing gaps in the understanding of the risks of these treatments with new research.
“HHS and the FDA have claimed that the removal of the boxed warning for hormone replacement therapy will ‘restore gold-standard science to women’s health,’” Nina Zeldes, Ph.D., a health researcher at Public Citizen’s Health Research Group, said in a statement. “In fact, the opposite is true.”
These treatments have well documented cardiovascular, cognitive, and cancer safety risks, Zeldes said.
“Overblown press conference announcements and unsubstantiated labeling updates do not protect women’s health,” she said. “The FDA should advance women’s health by making decisions based on high-quality data from long-term randomized controlled trials and the formal advisory committee process.”
In Monday’s announcement, the FDA also seemed to blatantly promote the off-label use of HRT for some conditions for which it isn’t approved, such as preventing cardiovascular disease and cognitive decline, Zeldes said.
“Unsubstantiated claims by senior FDA officials about the effectiveness of hormone replacement therapy for unapproved indications undermines public trust in the agency’s decision-making,” Zeldes said. “The U.S. Preventive Services Task Force has consistently recommended against hormone replacement therapy for the prevention of chronic conditions in post-menopausal women.”
Instead of making unsubstantiated claims about improving women’s health, the FDA should encourage or fund research that establishes the benefits and risks of short-term and long-term use of HRT, she said.
In the past, the ACOG has asked the FDA to take another look warning labels on low-dose estrogen products administered vaginally. However, it continues to have concerns about systemic estrogen products.
In an email to NPR, the FDA shared several studies in support of its decision, the NPR article said. The studies were published between 1980 and 1996. And one analyzing 30 studies from 1966 through 2003 was published in 2004.
Check with your health care providers on what they recommend in light of the FDA’s speedy decision on HRT, which is likely to make lots of money for pharmaceutical companies.
