Women's Studies 30
"Women Don't Get AIDS, They Just Die From It . . ."
Clinical Trials Show Why We Still Need to Fight for Women with HIV
Coined in earlier years of the HIV/AIDS epidemic, this activists' adage shows the frustration of women affected by HIV/AIDS but ignored by the bureaucracy or the American public. Many symptoms of HIV in women were not recognized, and the medical standard of care was often extremely low. Combining these issues with the fact that there were far fewer cases of HIV/AIDS in women than in men, women living with HIV/AIDS were virtually invisible (Gena Corea describes this phenomenon in The Invisible Epidemic). Today, both knowledge of the natural history of HIV in women and the standard of care have increased. Sadly, so have the numbers of women with HIV; HIV has become a women's issue.
There is still much work to be done, and one area of interest to many activists is changing the fact that women have not been involved in the clinical trials which test the safety and efficacy of HIV/AIDS drugs. The sections below give a brief narrative about the past and present situation, and there is also an accompanying timeline to show the issues in the context of a chronology. Citations are linked to the resources page, which has complete bibliographic entries for the information I used.
Why aren't there women in clinical trials?
In 1977, the United States Food and Drug Administration barred women of reproductive age from clinical trials - the research which must be conducted before the FDA gives its permission for the drug to be marketed. This decision was made due to the feared "fetal toxicity" of any given experimental drug; on the rare occasion that women were permitted in clinical trials, they were required to provide evidence of "detectable birth control". Men, despite the fact that their gametes can also be harmed by drugs, were not subject to any regulation of their sexual or reproductive lives. Even women with life-threatening conditions were excluded. This aspect of medicine in the U.S. is another glaring example of our society's view of women as vessels, little more than a reproductive tract. As seen in law at the national and state levels, the primacy of the fetus has been instituted over the autonomy of the woman in an alarming trend of the past twenty-five years. Roth, et al. explain: "Within the past 20 years, the participation of women in trials has been further eroded - a larger percentage of recent trials enroll men only than in the early seventies" (p.183, citing Schmucker and Vessel).
However, women and their advocates have been fighting the whole way. Thanks to the women's health movement, many Americans have not been willing to sit down and watch as drugs tested only on men are prescribed to women or the latest advances are denied to women because harm to their potential offspring is feared (but unstudied). Some of these people have pushed the FDA to change the 1977 rules. Though in 1986 the National Institutes of Health published a policy statement about including women in research, in 1987 the General Accounting Office found that this mildly-worded attempt at evening things our hadn't had much impact - only 13.5% of NIH moneys were being spent on women's health and the policy was being implemented erratically throughout government offices (McGovern, 44). Over the years, the NIH continued to issue guidelines on the issue, but drug companies continued to ignore these unenforceable suggestion. The companies, which run the trials with federal approval, relied on the "fetal toxicity" loophole, fearing the extra expense of including women or encountering lawsuits from the offspring of female subjects who had been affected by their mothers' use of the drug. Even after the NIH adopted stronger guidelines in 1994, loopholes for excluding women exist. The same holds true of the 1993 FDA "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" (see McGovern for more description).
What happens when women aren't involved in clinical trials?
Drugs tested only on men are more dangerous for women. Not only may the dosages need to be different due to women's smaller average size, but a drug may behave differently in a body with female chemistry. Furthermore, drugs to help conditions which present only in women may never be tested. This certainly may be the case with HIV. For years, many symptoms of AIDS in women weren't even acknowledged in government descriptions of the disease. Only in 1993 did the Centers for Disease Control and Prevention (CDC) add gynecological conditions like vaginal candidiasis and invasive cervical cancer to its surveillance definition of AIDS. Meanwhile, Kaposi's sarcoma, rarely present in women, was the most recognized indicator of AIDS. As a result, AIDS was less understood in women, and women did not reap as much benefit from advances in technology. Also, women were coming into contact with health care providers at later stages in their disease and were therefore exhibiting higher mortality.
What happens when women are Involved in clinical trials?
The HIV/AIDS research that has been done on women has almost exclusively focussed on vertical or perinatal (i.e., during birth) transmission of the virus from mothers to babies. Without any intervention, only about 25% of babies born to American HIV-positive women contract the virus from their mother; in Europe, this statistic is as low as 13% (Murrain, 67). Despite the fact that HIV is growing quickest in women, people of color, and people having heterosexual sex, the research on HIV in women is primarily about giving drugs to women during pregnancy and child birth.
The most famous example of this is the AIDS Clinical Trials Group Protocol #076 [ACTG 076]. ACTG 076 was developed to see how AZT (one of the first AIDS drugs developed, also known as zidovudine or ZDV) taken during pregnancy would affect perinatal transmission rates; in 1994 the study was unblinded because transmission rates had decreased from 25% to 8%.
While some hailed it as an incredible achievement, activists noted that the decrease was not in fact dramatic and that neither cofactors nor the biological nature of perinatal transmission had been addressed. Furthermore, the effects of the AZT on the mothers and babies wasn't investigated, despite the fact that many side effects of AZT have been observed since it came into wide usage in the 1980's. And though researchers celebrated the 8% statistic, no-one endeavored to examine why European countries routinely post a rate of 13%.
Research involving women often investigates mere pharmacology, neglecting issues that may have an even greater effect on women with HIV. Psychosocial factors have been shown to play a huge part in women's health decision-making; for example, women will often put other family-members' health needs above their own, resulting in delayed care (Walmsley, in Sherr).
What affects women's decisions about enrolling in clinical trials?
The barriers which affect women seeking health care can also getting in the way of their involvement in clinical trials. People of color (particularly African-Americans), former injection drug users, the poor, and single parents are also underrepresented, so a woman with HIV can have lots of strikes against her in terms of factors deterring her participation. While researchers work on "RRC" (recruitment, retention, and compliance) of these groups, women evaluate their potential particpation by multiple criteria (Roth, et al., 183).
The barriers which most affect women's participation in studies are
(Roth, et al., 186-187)
Ryan has found that the factors most predictive of any individual's decision to enroll in a trial are
(Roth, et al., 184)
Comparing these two lists illustrates how simple barriers to primary care for women can easily become barriers to their involvement in clinical trials. For example, someone who has trouble with transportation might have difficulty extablishing a regular enough relationship with a provider to learn about experimental drugs and trials.
African-American women, who are more likely to be single parents and/or live below the poverty like, are a particularly important area of focus. For HIV-negative African-American women, free well-baby care is the biggest incentive for participation, while for HIV-positive women of all races are most encouraged by the availability of counseling (Roth, et al., 192). Overall, it is women's access to health systems, not their marital or socioeconomic status, which affects their interest in clinical trials. Women are also much more affected by the social aspects of the study - relational contact with providers running the research, for example. Women are also more likely than men to use social services provided with research - housing, childcare, hotlines, etc.
How does all of this affect public policy about HIV and AIDS?
There is no way to avoid the fact that the AIDS epidemic is also a political crisis. Because of this, and the fact that so many of the issues brought up are social, it would be a disservice to have this discussion of clinical trials without asking how it relates to the broader climate surrounding HIV.
This discussion has highlighted the ways in which women with HIV have been neglected by the medical establishment, but the political arena is equally flawed. Over and over, women have borne the brunt of HIV policy, despite the inattention paid to their health.
Witness the mandatory testing amendment to the Ryan White CARE Act proposed by Tom Coburn, or Coburn's other work on HIV legislation, which hits women particularly hard. Activists have fought back, but ideas like Coburn's to make sense to a lot of Americans, who aren't aware of the dangerous ways in which women with HIV are marginalized.
>see bibilography< >see timeline<
--moriah mcsharry mcgrath
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last updated 12 December, 1998webmaster