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Executive Summary

NIH's NEW OFFICE OF WOMEN's HEALTH RESEARCH will be headed on an interim basis by Ruth Kirschstein, MD, director of the National Institute of Medical Sciences. The creation of the Office of Women's Health Research was announced at a Sept. 10 press conference and roundtable discussion of women's health issues at the National Institutes of Health. At the press conference, NIH Acting Director Raub said that "the new office will have authority and responsibility to act with and on behalf of the NIH director to monitor and coordinate activities of the constituent institutes, centers and divisions at NIH in regard to research on women's health." Raub said that the Office of Women's Health Research will require "at least $1 mil." in operating costs in its first year, and up to $10 mil. annually thereafter. Raub announced that recruitment for the senior executive position of the new office will begin "immediately," but in the interim, Kirschstein, who is also a co-chair of the Public Health Service Coordinating Committee on Women's Health Issues, will serve as acting director. As co-chair of the PHS group, Kirschstein has been responsible for helping to coordinate the activities of the NIH's Advisory Committee on Women's Health Issues since 1985. These activities have included: the publication in 1987 of a new NIH Guide to Grants and Contracts that called for greater inclusion of women in clinical testing; the 1989 release of a text profiling the roles of 412 prominent female scientists at NIH, entitled "NIH Women in Science"; and the completion of an inventory of all NIH-funded activities relating to women's health issues in fiscal 1987. The study, completed in 1989, found that only 13.5% of NIH's entire budget in FY 1987 was spent on investigating health issues of specific or exclusive concern to women. The NIH Advisory Committee on Women's Health Issues is currently analyzing NIH's FY 1988 and FY 1989 budgets to determine what percentage of funding in those years was directed at research involving women's health issues. Kirschstein said that the new office "will maintain a close working relationship with the NIH Advisory Committee on Women's Health Issues." In conjunction with the NIH Office of Extramural Research, the new Office of Women's Health Issues will also work to find new ways of including women, particularly women of childbearing age, in clinical research, Kirschstein said. The new office, along with the National Institute of Child Health and Human Development, already has contracted with the Institute of Medicine for a meeting on this subject. The IoM will be asked to address several topics, Kirschstein said, including: "how to include women of child-bearing age in clinical research while dealing with problems related to potential fetal damage, safety and liability; establishing of guidelines to determine when clinical studies should be designed to evaluate gender differences; [and] establishing guidelines to determine when changes in drug metabolism during the menstrual cycle should be investigated." Kirschstein said that a report from the IoM meeting "will serve to help chart future activities at NIH." She added that the new office intends to put together a planning group this fall to prepare for a major conference next spring with the aim of setting an agenda for NIH research on women's health. Sen. Mikulski (D-Md.), Rep. Morella (R-Md.), Rep. Schroeder (D-Colo.) and HHS Assistant Secretary for Health Mason also attended the press conference. Mikulski said she was prepared to request appropriations of up to $10 mil. for the office in its first fiscal year. All three members of Congress were critical of the handling of women's health issues by the Administration. When Mason failed to provide Mikulski with a clear timetable for the new office's activities, she criticized his replies as "not good enough."



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