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NIH and WHI-time for a mea culpa and steps beyond*

Utian, Wulf H. MD, PhD

doi: 10.1097/gme.0b013e3181589bfe
Personal Perspectives

The termination of the estrogen-progestin arm of the Women's Health Initiative (WHI) 5 years ago was abrupt and poorly planned. It has also become manifestly clear that the reporting at that time of the balance of risk and benefit for perimenopausal and early postmenopausal women was grossly exaggerated. Subsequent WHI publications including subanalyses of original data suggest a persistent pattern of over-reading of results toward a negative bias. The initial 2002 conclusion of the WHI investigators that harm was greater than benefit appears to be the result of several factors. One was the failure to recognize that initiation of therapy by decade of age or time since menopause was highly relevant; the WHI committee aggregated all outcome data into one group, even though in their demographic description they had the ability to investigate by age. An overhanging question is, therefore, what did they know, and when did they know it? Another factor was the utilization of a nonvalidated index termed the "global health index" that inexplicably assumed for comparison sake that all diseases were equivalent, for example, that a stroke was equivalent to a hip fracture in morbidity, mortality, and impact on quality of life. Although not a study about menopause, the data were extrapolated to all peri- and postmenopausal women. Despite the overall positive outcome of their results for women aged 50 to 60 years, most particularly those receiving estrogen-only therapy, the WHI investigators have irrationally maintained a defense of their misinterpretations of 2002. It is time for the National Institutes of Health and the WHI investigators to issue a final overall report that is clear and based on their actual results and not their personal interpretations. There is too much relevant and important information within the WHI to allow the overall study to continue to be perceived as biased to the detriment of both the National Institutes of Health and the study itself.

The initial analysis and interpretation of the prematurely terminated hormone therapy arms of the WHI were fatally flawed. Subsequent WHI publications in fact demonstrate that benefit: risk is favorable in direct relationship to proximity of menopause or decade of age. The NIH needs to recognize and address this misdirection in science.

From The North American Menopause Society.

Received August 6, 2007; revised and accepted August 16, 2007.

Financial disclosure: Dr. Utian as served on the Advisory Board for Roche/Glaxo Smith Kline Boniva OB/GYN, Merk Gynecology, GSK SERM Global and Eli Lilly Breast Cancer Reduction Advocacy. He has also served as a consultant for Pfizer, Berlex, Organon, Barr/Duramed, Novo Nordisk, Depomed, Gerson Lehrman, McKinsey, Goldman Sachs and Bradley.

Address correspondence to: Wulf H. Utian, MD, PhD, Consultant in Women's Health, Executive Director, The North American Menopause Society, 5900 Landerbrook Drive, Suite 390, Mayfield Heights, Ohio 44124. E-mail: utian@menopause.org

*Based on Utian WH. Editorial. Menopause Manage. 2007;16:8-12.

©2007The North American Menopause Society