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The cost of the combined therapy arm of the Women’s Health Initiative (WHI) trial was an eye-watering $260 million dollars when calculated at 2012 rates, but ‘the real’ return to the US economy was an even more staggering $37 billion, according to a recent health outcomes modelling study. ‘The EþP trial made highvalue use of public funds with a substantial return on investment’, said the investigators, some of whom included usual suspects from the original trial of 2002 and from the trial’s sponsors at the National Institutes of Health (NIH). Calculated over a study period from 2003 to 2012, the outcome of the trial was found to represent an economic return of $140 for every dollar spent – and a persuasive case for ‘for large, prospective trials with high potential for public health effects’. ‘Americans should be pleased to see that their investment in NIH continues to provide such a strong return to their health and the economy’, added the NIH Director in a press statement. The model for the study included disease incidence, direct medical expenditure, quality-adjusted life years and net economic return in approximately 39.1 million women eligible for combined hormone therapy between 2003 and 2012 in either a ‘WHI scenario’ or a parallel universe of ‘no-WHI scenario’. With this distinction and an estimation of who would (and would not have) used combined hormone therapy, it was projected that the WHI scenario resulted in 4.3 million fewer users of combined therapy than the no-WHI scenario, 126,000 fewer breast cancer cases, 76,000 fewer cardiovascular events, 145,000 more quality-adjusted life years, but 263,000 more fractures and 15,000 more colorectal cancers. Lead study author Roth said that the quality of life, mortality and cost impacts of more osteoporotic fractures (and colorectal cancers) were more than offset by the decreases in breast cancers, cardiovascular disease and venous thromboembolism. Resulting expenditure savings were thus put at $35.2 billion (which included the savings on drug costs) and a net economic return $37.1 billion. The original budget for the WHI, according to a 1992 press release from the NIH, was $625 million, with a duration of 15 years and the inclusion of 150,000 women. It was billed as ‘the largest coordinated study of women’s health ever undertaken’; in the event there were 16,608 women with an intact uterus in the combined therapy study, and 10,739 women without a uterus in the estrogen-alone trial. ‘The motivation for the first WHI trial was to see if we could prevent heart disease’, said Garnet Anderson, an investigator from the original WHI study.