Health Affairs 2026 analysis of lack of nuance in decades-long media coverage of hormone therapy (HRT) warnings on breast cancer and FDA removal of black box.
By Kelly Pender and Bernice L. Hausman, November 9, 2026
The answer lies in a powerful narrative circulating for years before the FDA convened its panel, one that recast the original study linking hormone replacement therapy with breast cancer risk as flawed.
Irregularities in medical regulatory processes have been in the news a lot lately. In 2025, the Department of Health and Human Services Secretary Robert F. Kennedy Jr. fired members of the Advisory Committee on Immunization Practices and then, with a newly constituted committee, altered some federal recommendations for childhood vaccines and made others more difficult for adults to access. More recently, the Food and Drug Administration (FDA) recommended expanded consumer access to peptides, despite cautions from agency scientists. In both cases, news media highlighted the abandonment of procedural norms and rejection of scientific expertise, warning that these regulatory deviations could jeopardize public health.
Yet when the FDA made an equally irregular decision about hormone replacement therapy (HRT), removing black box warnings about breast cancer risk after a closed panel stacked with HRT advocates, the news coverage looked very different. There were few warnings about abandoned procedural norms or alarms about public health. Instead, the response was largely celebratory, as outlets such as CBS News framed the change as the end to “an American tragedy.” Why the discrepancy? What made this regulatory irregularity acceptable while others drew such scrutiny?
The answer to this question lies in a powerful narrative circulating for years before the FDA convened its panel, one that recast the original study linking HRT with increased breast cancer risk as flawed. By the time the FDA acted in 2025, that narrative had done its work: Removing the warning wasn’t seen as controversial but instead as an overdue correction to a wrong that had harmed thousands of women.
We are making two connected claims here. The first is that a narrative of error and correction emerged over two decades of news coverage of the original study, the Women’s Health Initiative (WHI). That narrative framed the scientifically uncertain findings of the WHI as flawed results, which made the FDA’s eventual decision to remove the black box warning seem logical. The second claim is that the FDA’s process for removing that warning was irregular by its own standards, yet unlike similarly irregular processes concerning vaccines and peptides, it drew little scrutiny. These two claims reinforce each other in a specific way. When a regulatory outcome confirms what stakeholders already believe, they are less likely to examine the process that produced it. Additionally, when the process goes unexamined, no one asks whether the evidentiary basis for the decision would have withstood the scrutiny that a proper advisory panel would have required. The narrative, in other words, both pre-legitimized the outcome and provided cover for a process that substituted advocacy for scientific review.
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What The Science Actually Found …
To understand the power of the error and correction narrative, it helps to look at the WHI’s scientific findings, beginning in 2002 and continuing for two decades after. In 2002, the WHI’s independent data safety and monitoring board found that combined HRT (a formulation including both estrogen and progestogen, a synthetic form of progesterone) increased breast cancer risk. The finding was sweeping, articulated in definitive and urgent language. HRT use plummeted and remains lower today.
Over the following two decades, however, medical understanding of HRT and breast cancer risk became significantly more nuanced. Researchers emphasized that timing mattered (risk varied depending on when treatment started and how long it continued); biological mechanism mattered (HRT could fuel breast cancer growth and hinder detection); and patient factors mattered (population-level averages could obscure individual risk variations). These findings didn’t eliminate scientific confidence in the existence of risk; rather, they made that confidence conditional, meaning that the relationship between HRT and breast cancer was too complex for universal guidelines and instead required individualized clinical judgment.
The WHI itself acknowledged this: The 2002 Journal of the American Medical Association (JAMA) WHI write-up stated plainly that the trial did not address the short-term risks and benefits of hormones given for the treatment of menopausal symptoms. This distinction was almost entirely lost in news coverage.
… And The Narrative That Replaced It
Indeed, if medical science about HRT grew more nuanced in these decades, the news did not. By 2020, major outlets had a simpler story to tell, a narrative of error and correction: The WHI was wrong, women had been failed by bad methodology and medical sexism, and an entire generation of clinicians had been trained on a flawed study.
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It is this narrative about the WHI that paved the way for the November 2025 decision to remove black box warnings from HRT products.
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Yet coverage of the FDA’s November 2025 announcement illustrates how thoroughly that narrative had already done its work. CBS News called the change a “major turnaround,” leading with FDA Commissioner Martin Makary’s characterization of two decades of medical caution as a “fear machine” driven by “dogma” and “groupthink,” language that CBS reproduced without mentioning the irregular process by which the decision was reached. While National Public Radio (NPR) noted that the expert panel was not a substitute for a full FDA advisory committee, it included limited criticism of the decision and Makary’s own dismissal of such committees as “bureaucratic, … and very expensive.” NPR also highlighted Makary’s framing of HRT as “life-changing, even lifesaving.”
The New York Times did include criticism of the warning removal, quoting Diana Zuckerman of the National Center for Health Research, who cautioned that claims about hormone therapy’s broad benefits were “inconsistent with years of research” and would harm millions of women. Zuckerman’s concern is an important reminder that there have always been clinicians, researchers, and patients who have resisted an either/or approach to HRT. While the error-and-correction narrative is powerful, it has by no means completely silenced calls for a more nuanced approach to the scientific evidence.
But even an article that raised questions about the safety of HRT led with Makary’s framing, and the issue of irregular FDA process, which dominated coverage of the peptide and vaccine recommendations, was largely absent. The New York Times article noted in passing that critics had urged Makary to convene a scientific advisory panel, but that procedural concern was voiced in one sentence, in comparison to the several paragraphs devoted to Makary’s characterizations.
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To read the entire article, click here The FDA’s HRT Decision Was Irregular. Why Didn’t Anyone Notice? | Health Affairs