Doctors respond to ‘data-free’ decision on menopausal hormone therapy: ‘It’s not true’ | Trump administration

Last week, FDA Commissioner Marty McCurry announced that estrogen-related medications for menopause will no longer carry broad warnings, bypassing the regulatory agency’s typical process and, according to experts, overstating the science behind the drugs — with troubling implications for future drug decisions.

The decision to remove an ominous warning from 2003 about the risks of cardiovascular disease, breast cancer and dementia makes sense for local vaginal estrogen products, but systemic estrogen is more complex, menopause experts say — and more than these nuances, they worry about the scientific process, or lack thereof, in making the decision.

Hormone therapy can relieve menopausal symptoms, including hot flashes, insomnia, and joint pain. But health officials viewed the benefits as a major step forward, noting that the treatment could also prevent heart disease, osteoporosis, Alzheimer’s disease and death.

“There may be no other drug in the modern era that can improve health outcomes for women at a population level more than hormone replacement therapy,” McCary said, calling it a “life-changing, even life-saving treatment” and calling the ad a “medical breakthrough.”

Other officials at the news conference offered similarly rosy views.

Robert F. Kennedy Jr., US Secretary of Health and Human Services, said that hormone therapy “prolongs life by up to 10 years.”

“Today, we have the opportunity to add up to a decade of healthy years to the lives of every woman she loves,” said Alicia Jackson, president of the Advanced Research Projects Agency for Health and founder of Evernow, a startup that offers virtual menopause care. “Estrogen is one of the most effective interventions for prolonging lifespan for women.”

However, the researchers said there is no evidence that hormone therapy has benefits among a broader group of menopausal women, other than those with symptoms.

“Making this blanket statement that every woman should take this to prevent heart disease — it’s not true,” said Lauren Streicher, MD, professor of obstetrics and gynecology and founding medical director of the Center for Sexual and Menopausal Medicine at Northwestern University School of Medicine.

Pauline Mackey, a professor of psychiatry, psychology and obstetrics and gynecology at the University of Illinois College of Medicine, said the “data-free” decision sends a “harmful” and confusing message.

“Women are trying so hard to get the truth, and they’re having a really hard time,” she said. When it comes to using menopausal hormone therapy to treat dementia, which is her area of ​​expertise, “the harm may be real, but it certainly doesn’t show benefit.”

A Department of Health and Human Services spokesperson said, “Randomized studies show that women who start HRT within 10 years of the onset of menopause (usually before age 60) have a reduced rate of all-cause mortality and fractures.”

The Department of Health and Human Services did not respond to questions about officials’ statements about alleged protection against dementia and other issues or evidence of widespread use of the drugs.

This is the first time that the FDA has relied on a roundtable panel, which was not previously open to public comment, to inform regulatory decision-making. According to To the pink paper. Streicher, who has long called for changes to black box warning, was scheduled to sit on the committee in July, but withdrew after several initial meetings.

“It became very clear to me that this was not going to be a scientific committee. This is not the scientific approach,” she said. “I said, ‘I’m out. I don’t want any part of this.’

Streicher attended the press conference earlier this month. “They were trying to get people to fill the room,” she said. Streicher said organizers urged attendees to wear their white coats to give the event the feel of an experience. Didn’t do that.

She says she’s concerned about the precedent set by the decision. The agency is also re-examining medications such as mifepristone, a safe and effective abortion drug.

“It was very clear that McCary actually had an agenda, that he wanted to remove these labels, and it was just kind of public rhetoric for people who were motivated saying, ‘This is why this needs to happen,’” she said. “They select people who they know are going to say what they want to say.”

McCary’s latest book contains a chapter on hormone replacement therapy, titled OMG HRT, arguing that hormone therapy has been shown to “increase women’s longevity by three years.” The most accepted medical term for treating women over 40 is menopausal hormone therapy (MHT). July plate It included researchers who had published research on menopause, as well as doctors with large social media followings; No oncologists were involved.

The process included allowing committee members to “express their opinions,” followed by a review of the FDA’s literature and a recommendation to “remove certain black box warnings,” which McCary himself signed off on, McCary said.

Typically, expert advisory committees hold public discussions about the evidence and then make recommendations to the FDA, which may or may not be accepted by the agency’s subject matter experts—rarely the commissioner.

In response to a question about the process, McCary said the FDA chose the committee because advisory committee meetings are “bureaucratic, lengthy, often conflicting and very expensive.” More panels with guests who’re talking [their] He added that “Mind with Passion” will happen in the future.

The evidence itself on medications is accurate. “There are really two very separate issues, which are their distortion,” Streicher points out.

Topical vaginal estrogen, usually a cream, tablet, supplement, suppository or vaginal ring, treats symptoms such as dryness and irritation as well as recurrent urinary tract infections and urgency. “These products are really quite safe,” Streicher said, adding that the warning should never have been applied to them.

Systemic estrogen is more complex. There are many preparations, applications, and ways of metabolizing it. Some specific medicines have risks – for example, oral estrogen increases the risk of a blood clot, while the transdermal patch does not. These labels need to be modified in a thoughtful, product-specific way, Streicher said. There is also a slight increase in the risk of breast cancer when using synthetic progesterone. The medications are not suitable for everyone, especially people with a history of breast or uterine cancer.

Mackey, a leading researcher in the field of menopause and dementia, once believed that memory problems could be linked to the loss of estrogen that occurs during menopause. Research has indicated that women who used hormone therapy to treat menopausal symptoms saw improvements in their memory. Mackey conducted a large randomization He studies Among a larger group of menopausal women, not just those with symptoms.

“Far from showing benefit, it actually showed a trend toward harm,” Mackey said. Three other large randomized trials had similar results.

Symptoms such as hot flashes can be incredibly annoying, with three-quarters of sufferers saying they have trouble sleeping, which may contribute to memory problems, especially over seven or eight years.

McKee now believes that treating those symptoms — whether with hormone therapy or other medications — is the key to improving memory, as shown in another study of hers using a non-hormonal treatment. Mackey said the broader use of hormone therapy to prevent dementia “is not based on science.”

However, in an “astonishing” move, health officials cherry-picked data from a small study in one community while ignoring larger randomized trials, Mackey said. Officials viewed the decision as a move against “medical group ideology” and “medical dogma,” as Makary put it.

“For the first time in a generation, the FDA stands with science and stands with women,” Kennedy said. “Today, we are restoring integrity to medicine, and restoring trust in public health.”

The American medical establishment has turned its back on women, said Kennedy, who recently sought to link women’s use of Tylenol during pregnancy to autism. “This classification was designed to intimidate women and silence doctors,” Kennedy said, denouncing the “culture of fear.”

McCary said the decision was a “challenge to the paternalism of medicine,” but then said that hormone therapy “saved the marriage,” noting that one of the main results of the drug was marital satisfaction.

“It was not only scientifically incorrect, it was also insulting,” Streicher said.

She said that hormone therapy is safe and effective for those suffering from menopausal symptoms: “But do I tell every woman going through menopause that she needs hormone therapy? Absolutely not.”