Women's Studies 30



1977 FDA policy focusing on preventing harm to fetuses effectively excludes women of "childbearing age," even those with life-threatening conditions as pharmaceutical companies claim potential "fetal toxicity" to avoid potential lawsuits

1981 first cases of what is now know as AIDS reported - 5 women are among the population; FDA requires that study participants be informed of test results in animals

1983 AIDS-causing retrovirus discovered

1985 reliable HIV antibody test developed

1986 virus renamed HIV; NIH publishes policy statement on including women in clinical trials

1987 13.5% of NIH moneys dedicated to women's health issues; GAO finds nonuniform NIH policy implementation

1988 revised NIH guideline suggests "by-gender" analysis of data being collected in clinical trials - does not establish clear standards for women's inclusion

1989 NIH publishes further guidelines on women's inclusion

1990 women's clinical progress first becomes research enterprise (Patton, 1994)

1992 HIV Law Project, NOW Legal Defense and Education Fund, ACLU AIDS Project submit petition to FDA commissioner calling for concrete revision of discriminatory 1977 FDA guidelines

1993 FDA publishes "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" - still has loopholes for the exclusion of women, allows human testing to start before completion of animal studies; ACTG 076 protocol studying AZT and vertical transmission begins; CDC revises clinical definition of AIDS - now includes invasive cervical cancer and CD4 count <200; Schmucker and Vessel find that "a larger percentage of recent trials enroll men only than in the early seventies" (Roth, et al., 1998)

1994 "NIH Revitalization Act" of 1993 implemented - mandates recruitment of diverse subjects in federally-funded research; ACTG 076 unblinded due to perceived success

1996 deaths among women with HIV in America up 3% while down 15% among men (Reuters, 1996)

1997 women account for more than half of HIV cases worldwide, seventy-five percent of cases are in women of color (Murrain, 1997)

1998 U.S. Public Health Service recommends starting anti-retroviral treatment in women and men with viral load hits 10,000/ml. - research suggests that viral load may have different significance in different genders; the majority of studies of perinatal transmission in developing nations do not provide access to anti-retrovirals despite ACTG 076 findings (N.E. Journal of Medicine, 1998)


>return to main HIV trials page< >see bibliography<

--moriah mcsharry mcgrath

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last updated 12 December, 1998