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OPINION

A decade post WHI, menopausal hormone therapy comes full circle – need for independent commission

Pages 320-325 | Received 09 Mar 2012, Accepted 20 Mar 2012, Published online: 04 Jul 2012
 

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.

Conflict of interest Professor Utian is not consulting or on any pharma speaker panels on ET/EPT/HT. He is consulting on non-hormonal products for the following companies: Hygeia, Chair Advisory Board (from 11.27.07), Bionovo (from 03.01.08), Cleveland Clinic Foundation Innovations Center (from December, 2009), Pharmavite, Chair Menopausal Health Advisory Board (from 11.24.10), Merck, Sharp & Dohme (from 01.23.11), Novogyne (from 02.15.11), Bayer FSD Advisory Board (from 03.01.11), Teva Women’s Health Inc. (from 04.07.11), Pfizer Inc. (from 01.31.11 to 08.31.11).

Source of funding Nil.

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