The other side of a 60 Minutes sob story

The Independent Journal Review reported:

The Trump administration on Monday announced moves to reverse what Food and Drug Administration Commissioner Marty Makary has described as the “biggest error in modern medicine”—the longstanding medical advice to avoid hormone replacement in menopause.

The Department of Health and Human Services is recommending that women talk to their doctor about using hormone replacement therapy (HRT) to treat menopausal symptoms like hot flashes and night sweats—a major reversal to a recommendation in place since 2002 to avoid it because of an alleged breast cancer risk. FDA has initiated the removal of a black box warning on HRT drugs for women and approved two new HRT drugs.

“We’re challenging outdating thinking,” said HHS Secretary Robert F. Kennedy Jr. “For the first time in a generation the FDA is standing with gold standard science and with women.”

Second Lady Usha Vance attended the press conference.

The longtime recommendation hinged on an alleged association between HRT and breast cancer announced by administrators of the Women’s Health Initiative, a multimillion-dollar National Institutes of Health study, in 2002. The media attention led prescriptions of HRT for menopausal symptoms to plummet. The study coauthors announced the finding to the press before releasing the underlying data a few days later. Third party scientists soon discovered that the alleged association did not meet standards of statistical significance. The finding was no more than a statistical blip.

Use of HRT can reduce bone fractures when taken within 10 years of the onset of menopause and reduce risk of cardiovascular disease and Alzheimer’s disease, according to studies cited by HHS. A meta analysis of 30 trials encompassing nearly 30,000 women found HRT was not associated with increased cancer mortality.

So the federal government funded research that turned a statistical blip into recommending women not taking a treatment for the discomforts of menopause.

This bad advice increased the odds of bone fractures, cardiovascular disease and Alzheimer’s disease. For nearly a quarter-century, the FDA has warned women against using a perfectly fine treatment for menopause that may help prevent worse health problems.

One flawed government study endangered the health of millions of women.

The New York Times exposed this scandal on February 1, 2023, when Susan Dominus wrote, “Women Have Been Misled About Menopause. Hot flashes, sleeplessness, pain during sex: For some of menopause’s worst symptoms, there’s an established treatment. Why aren’t more women offered it?”

She was in menopause. Personal experience helps in journalism.

She wrote:

Menopausal hormone therapy was once the most commonly prescribed treatment in the United States. In the late 1990s, some 15 million women a year were receiving a prescription for it. But in 2002, a single study, its design imperfect, found links between hormone therapy and elevated health risks for women of all ages. Panic set in; in one year, the number of prescriptions plummeted.

Hormone therapy carries risks, to be sure, as do many medications that people take to relieve serious discomfort, but dozens of studies since 2002 have provided reassurance that for healthy women under 60 whose hot flashes are troubling them, the benefits of taking hormones outweigh the risks.

The treatment’s reputation, however, has never fully recovered, and the consequences have been wide-reaching. It is painful to contemplate the sheer number of indignities unnecessarily endured over the past 20 years: the embarrassing flights to the bathroom, the loss of precious sleep, the promotions that seemed no longer in reach, the changing of all those drenched sheets in the early morning, the depression that fell like a dark curtain over so many women’s days.

The study was conducted by the Women’s Health Initiative, which is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; U.S. Department of Health and Human Services. In other words, taxpayers and the $38 trillion national debt.

The NYT story said:

On July 9, 2002, the Women’s Health Initiative’s steering committee organized a major news conference in the ballroom of the National Press Club in Washington to announce both the halting of the study and its findings, a week before the results would be publicly available for doctors to read and interpret. Jaques Rossouw, an epidemiologist who was the acting director of the W.H.I., told the gathered press that the study had found both adverse effects and benefits of hormone therapy, but that “the adverse effects outweigh and outnumber the benefits.”

The trial, Rossouw said, did not find that taking hormones protected women from heart disease, as many had hoped; on the contrary, it found that hormone therapy carried a small but statistically significant increased risk of cardiac events, strokes and clots — as well as an increased risk of breast cancer. He described the increased risk of breast cancer as “very small,” or more precisely: “less than a tenth of 1% per year” for an individual woman.

What happened next was an exercise in poor communication that would have profound repercussions for decades to come. Over the next several weeks, researchers and news anchors presented the data in a way that caused panic. On the Today show, Ann Curry interviewed Sylvia Wassertheil-Smoller, an epidemiologist who was one of the chief investigators for the W.H.I. “What made it ethically impossible to continue the study?” Curry asked her. Wassertheil-Smoller responded, “Well, in the interest of safety, we found there was an excess risk of breast cancer.” Curry rattled off some startling numbers: “And to be very specific here, you actually found that heart disease, the risk increased by 29%. The risks of strokes increased by 41%. It doubled the risk of blood clots. Invasive breast cancer risk increased by 26%.”

All of those statistics were accurate, but for a lay audience, they were difficult to interpret and inevitably sounded more alarming than was appropriate. The increase in the risk of breast cancer, for example, could also be presented this way: A woman’s risk of having breast cancer between the ages of 50 and 60 is around 2.33%. Increasing that risk by 26% would mean elevating it to 2.94%. (Smoking, by contrast, increases cancer risk by 2,600%.)

NYT was being polite. Instead of saying your risk will rise 0.61%, one of the chief investigators said it would be a 26% increase. This was a deliberate deception.

Cynthia Thomson and Garnet Anderson Seattle, members of the Women’s Health Initiative Steering Committee, wrote a letter to the editor, which was published, and said:

The WHI provides some insights that are helpful to younger women. Firstly, it is imperative that women and their care providers distinguish between combined hormones (estrogen plus progesterone) for women who have not had a hysterectomy, and estrogen alone for women who have had a hysterectomy. The risks and benefits for major chronic diseases seen with combined hormone therapy use weighed heavily towards overall risk, including for breast cancer, with no significant trends by age. For estrogen used by itself among women who had a hysterectomy, there were fewer adverse effects, a reduced risk of breast cancer, and a trend with age towards overall benefit for younger women. Secondly, for both women with and without a uterus, the absolute risks, i.e., the excess numbers of women who would experience adverse effects, rather than the percentage change, are much lower in younger women.

Therefore, we agree that the benefit of symptom relief may well outweigh any small risks in perimenopausal women. This is especially so for estrogen alone, but even for combined hormone therapy, the short-term risks are low. Of course, treatment decisions should consider a woman’s individual profile, such as severity of symptoms and presence of risk factors for heart disease, stroke, breast cancer, and bone fractures.

They were confident that the funding would keep a-coming.

Then Robert Francis Kennedy Jr. became head of Health and Human Services. He cut off their funding and set a deadline. The organization got it restored but the message was clear: Play it straight.

I mention all this because 60 Minutes aired a sob sister story about Trump cutting research funding to Harvard and other colleges with huge endowments, anti-Semitism and racist biases against Asian-Americans. The key excerpt:

Bill Whitaker: “If you were talking to the American public, what would your research do for them?”

Joan Brugge: “My research has the potential to prevent their daughters, and their wives, and their cousins from developing breast cancer, and I don’t think any taxpayer would want to interfere with progress on a project like that.”

Joan Brugge is director of the Ludwig Cancer Center at Harvard Medical School. For 50 years, she has applied for and won competitive federal grants that helped uncover how tumors form and resist treatment and discovered innovative therapies. When her million dollar annual funding was cancelled last spring, she was leading a team that had identified the earliest precursors of breast cancer.

So she has been studying this for 50 years and the cure still is just around the corner.

If her work were important, Harvard would dip into its $53 billion endowment and fund it. Don’t hand me that baloney about covenants from donors that restrict spending because most of that money reflects profits from investments.

Brugge has knocked down plenty of federal funds for Harvard in the past half-century in the name of breast cancer research.

Here are some of the other National Institute for Health grants issued in the past 5 years: $465,339 to study Pigeons Gambling on Slot Machines, $5 million to study Drunken Finches Slurring Songs, $1.3 million to study Shrimp on Tiny Treadmills, and $250,000 to study Bees on Cocaine.

To be fair, studying pigeons playing the slots harmed no one. Scaring millions of menopausal women out of a fairly safe treatment did.

Government studies are as politically charged as anything else in government. Covid made us skeptics. Elon Musk made us penny-pinchers.