How the FDA Just Took Women’s Health Back Twenty Years

By erasing long-standing safety warnings on hormone therapy, the FDA just handed Big Pharma a major win—and passed the risk to women.

Dr. Marty Makary, the FDA’s commissioner, announced yesterday that the agency will remove the black-box warning from all estrogen-based hormone-replacement therapy (HRT) products. New labels will instead emphasize that HRT may offer long-term health benefits if begun within ten years of the onset of menopause.

That change overturns more than twenty years of established medical guidance that began after the Women’s Health Initiative (WHI) halted its massive clinical trial in 2002. The WHI found that HRT significantly increased the risks of blood clots, strokes, endometrial cancer, and breast cancer.

Makary framed his reversal as a long-overdue correction. “The long-term health benefits have been largely misunderstood,” he said. “Hormone replacement therapy may improve the health outcomes of women at a population level more than any other intervention, arguably with the exception of antibiotics or vaccines.” He even added that he wished his own mother had benefited from HRT when she went through menopause.

For those of us who have spent years reporting on the pharmaceutical industry and the troubled history of HRT, yesterday’s announcement was a disheartening step backward for women’s health. Gerald explored that history in PHARMA (Chapter 21, “Targeting Women”), and Trisha investigated it in No Hormones, No Fear, which exposed the hormone industry’s hard-sell marketing practices and offered natural alternatives to HRT for menopausal symptoms.

A Familiar Story: Profit Masquerading as Science

When Makary was asked whether HRT is safe for all women, he conceded that anyone with a history of hormone-fueled breast cancer or a predisposition to blood clots should avoid it. He admitted there were other contraindications—but those caveats were a passing footnote in an otherwise full-throated endorsement from the FDA’s top official.

No one would be happier with Makary’s decision than the late Dr. Robert Wilson, the Manhattan gynecologist who almost single-handedly turned HRT into a cultural phenomenon with his 1966 bestseller Feminine Forever. Wilson preached that estrogen was a fountain of youth and declared that post-menopausal women were “castrates.” Like Makary, he claimed his own mother’s menopause had transformed a “vital, wonderful woman” into a “pain-racked invalid.”

What the public didn’t know was that Wilson’s crusade was underwritten by Wyeth Pharmaceuticals, maker of Premarin—the most prescribed estrogen drug in America. Wyeth bankrolled Feminine Forever, paid for Wilson’s Park Avenue office and foundation, and funded his lecture tours to physicians and women’s groups. He also received money from Searle and Upjohn, both hormone manufacturers.

As we each documented in our books, Wilson’s son later revealed that his father’s wife had secretly undergone a mastectomy for breast cancer—information that Wilson and Wyeth hid to protect their business. The same pattern ran throughout the hormone industry: manipulated studies, concealed side effects, and relentless marketing built on fear of aging rather than genuine science.

How HRT Became America’s Miracle Drug—Then Fell Apart

By the early 1970s, thanks to Wilson’s evangelism and Big Pharma’s promotion, menopause was rebranded as a disease to be treated. Estrogen replaced the tranquilizers and antidepressants of the 1950s as the supposed cure for midlife female “malaise.”

It took fifteen years for reports about increased breast and uterine cancer caused by the high levels of estrogen in HRT to dent the drug’s sales. By 1990, however, it again became the top selling drug in the U.S. It held that title for another decade and exceeded by a third its mid-1970s pre–cancer scare peak. Wyeth-Ayerst’s “new and improved” combination pill, Prempro (estrogen + progestin), promised protection against uterine cancer and extended the boom.

Then came the reckoning. In 2002, the federally funded Women’s Health Initiative stopped its trial early after finding HRT raised risks for heart disease, blood clots, strokes, and breast cancer. The results made front-page news worldwide. Within a year, Prempro’s sales fell by two-thirds, Premarin’s by one-third, and neither ever returned to the pharmaceutical top ten.

For Big Pharma, those black-box warnings were devastating. They capped the potential customer base and curbed profits. For years afterward, drug companies lobbied successive FDA commissioners to lift the warnings, arguing that they were “too severe.” Until now, no one at the FDA bit.

The Industry’s Win—and Women’s Loss

The groundwork for Makary’s reversal was laid last August, when he reconstituted the FDA’s menopause advisory panel with physicians tied to a pro-HRT group backed by Bayer, Pfizer, and other hormone manufacturers. Yesterday’s decision is their payoff.

Some experts spoke out but were drowned in the celebration. “Removing the black box and burying warnings in a lengthy label that most doctors and patients won’t read takes women’s health backward,” said Dr. Diana Zuckerman, president of the National Center for Health Research. “The claim that hormones for menopause are the best way to improve women’s health contradicts years of research and will harm millions of women. There are far better ways to prevent osteoporosis, heart disease, cancer, and dementia.”

Yet for the pharmaceutical industry, the day was one of triumph. With the cautionary black label gone, the old marketing playbook returns—HRT as salvation, menopause as pathology, and women as the profitable patients in between.

We have been here before, and the ending was ugly. History tells us that when Big Pharma downplays risk to sell reassurance, it is women who pay the price.