title: A decade post WHI, menopausal hormone therapy comes full circle--need for independent commission.
abstract: The sudden decision by the National Heart, Lung, and Blood Institute of the National Institutes of Health to terminate the estrogen-progestogen therapy arm of the Women's Health Initiative (WHI) Study a decade ago now begs two questions:--has women's health after menopause been helped or harmed as a result of the findings and the way in which they were presented, and, if harmed, what needs to be done to put things right? Time and multiple reviews of specific publications from the WHI lead to the serious question whether a project designed to be of benefit to women's health has boomeranged, and instead may have resulted in significant impairment to both the quality of life and physical health of postmenopausal women. It is therefore urgent to confirm whether this is so and whether corrective action needs be taken to prevent even more harm. There are two obvious and immediate actions to be called for: (1) The Food and Drug Administration (FDA) needs to revisit the black-box warnings on postmenopausal hormones. Specifically, there needs to be a separation of the advisories for estrogen alone from estrogen and progestogen combined usage. (2) Justification is given to call for an independent commission to scrutinize every major WHI paper to determine whether the data justified the conclusions drawn. Women progressing through and beyond menopause in the next decade need to be spared the unnecessary harm that may have been inflicted on their sisters of the previous decade.
authors: The North American Menopause Society, and Reproductive Biology, Case Medical School, Cleveland, Ohio, USA.
authors: W H
authors: WH
authors: Utian
mesh_terms: D000328:Adult; D026683:Advisory Committees; D000367:Age Factors; D000368:Aged; D015982:Bias; D001943:Breast Neoplasms / Q000139:chemically induced; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000517:prevention & control*; D003627:Data Interpretation, Statistical; D005260:Female; D006620:Hip Fractures / Q000517:prevention & control; D020249:Hormone Replacement Therapy / Q000009:adverse effects / Q000706:statistics & numerical data*; D006801:Humans; D008593:Menopause / Q000187:drug effects; D008875:Middle Aged; D054555:National Heart, Lung, and Blood Institute (U.S.); D010024:Osteoporosis / Q000517:prevention & control; D017698:Postmenopause / Q000187:drug effects*; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration