New studies on hormone-replacement therapy elucidate the perils of ...

Yesterday's Wall Street Journal featured an article citing new studies that challenge the longstanding perception that hormone-replacement therapy (HRT) is an exceedingly risky treatment for women suffering from menopausal symptoms. This perception itself became widespread and entrenched roughly ten years ago following a government study conducted by the Women's Health Initiative that abruptly ended when data showed that women using HRT had higher rates of heart disease, stroke, and breast cancer than other menopausal women taking a placebo. However, new studies featured in the journal of the International Menopause society, Climacteric, indicate that some women using HRT can in fact benefit greatly from it; these women using HRT generally enjoy a relief from menopause symptoms as well as other significant health benefits, most notably a reduced rate of heart disease.

What separates these studies, and what led them to reach such widely divergent conclusions, is that they tested the effectiveness of HRT for women in marginally different age groups. The study published by the Women's Health Initiative primarily examined the effects of HRT on women who had long been in menopause--according to The Wall Street Journal, the average woman who participated in the Women's Health Initiative study had already been in menopause for 12 years. However, the Climacteric studies seem to corroborate the "window-of-opportunity" theory, which predicts that women who begin using HRT treatment before 60 or within ten years of menopause are more likely to experience health benefits than those who use HRT later in life.

The lesson to be taken from these studies is that medical research is done best when personalized and tailored to individual patients. The sweeping conclusions reached by the Women's Health Initiative a decade ago concerning the purported dangers of HRT for menopausal women only actually hold for a particular subset of menopausal women, and the health benefits of HRT for women who don't fall in that subset can be tremendous.

This case thus illustrates a serious danger latent in the "comparative effectiveness research" approach taken by the Patient Protection and Affordable Care Act: mass studies of how different treatments affect large swaths of people are not likely to pick up the subtleties and nuances in treatment effectiveness that can vary from person to person based on a whole range factors that determine each individual's unique biochemistry. These diverging studies further illustrate that the most significant advances in medical research, and by extension in medicine itself, are likely to be patient-oriented, but these advances may not be realized if we continue to support overbroad, one-size-fits-all "comparative effectiveness research" as our method for evaluating medical treatments.

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