Traditionally, women's health was thought of as maternal health and focused on pregnancy and reproduction. Nonreproductive biomedical research was rooted in the male model, with the belief that results could merely be extrapolated to the female, an approach sustained by the absence of women as participants in clinical research. In the 1980s and 1990s, largely through the efforts noted above, women's health moved beyond reproduction to include health across the life span. In 1985, the U.S. Public Health Service (PHS) first defined women's health as “diseases or conditions that are unique to or more prevalent or serious in women or have different outcomes or interventions.”67
Although this was a major step forward in establishing that women's health was more than reproductive health, it also implicitly reaffirmed men's health as the norm from which women's health exists only as a comparator. In 1994, the National Academy in Women's Health Medical Education (NAWHME) expanded the PHS definition to include wellness and prevention, the interdisciplinary and holistic nature of women's health, the importance of gender differences, and changes in women's health needs across the life course.68
With this expanded definition, women were no longer viewed through the lens of reproductive activities but with recognition of a host of health events across puberty, midlife, and aging. The Institute of Medicine (IOM) has since stressed the importance of research that acknowledges sex differences, describing sex categorization as a “basic human variable” and that sex influences human health not only through biology but through gender-related differences in behaviors, perceptions, environmental exposures, socioeconomic status, and public policy.69
This growing emphasis on the biology of sex and gender differences stimulated much laboratory and clinical investigation. Increased dollars were allocated in the 1990s to study women's health across the life span and to include women in clinical trials. The NIH Revitalization Act of 1993 required that NIH-funded clinical trials include women and minorities as subjects in approximately equal numbers of both sexes70
; other federal agencies adopted similar guidelines. Following this act and policy changes at FDA,30
women of childbearing potential could no longer be routinely excluded from clinical research.
In spite of the public attention that followed the 1990 GAO report indicating that only a small percent of the NIH funding for clinical research was addressing conditions that occur uniquely or predominantly in women,21
examples of the invisibility of women in clinical research continue to be published routinely in the highest-impact medical journals. For example, despite the far greater prevalence of depression among women, the only acknowledged gender differences in a New England Journal of Medicine
review paper on depression were that men are more successful than women in their suicide attempts and that older men are at high risk of suicide.71,72
The review made no mention of postpartum depression, which affects approximately 15% of all women who give birth,73
depression following miscarriage, the safety of antidepressants during pregnancy or lactation, or how to counsel women taking antidepressants who wish to become pregnant. Neither was there mention of some of the most potent risk factors for depression in women, including childhood sexual abuse,74
intimate partner violence,75,76
or sexual and gender-based harassment in the workplace.77–79
Additionally, little progress has been made in the inclusion of women in clinical trials, and clear statements of the limits of generalizability of male-only studies are routinely absent, in disregard of the rules of good science.80,81
An analysis of findings from randomized, controlled trials published in nine influential medical journals in 2004 showed that women were generally underrepresented, comprising on average 37% of the sample and only 24% of participants in drug trials. Eighty-seven percent of the studies did not report any outcomes by sex or include sex as a covariate in modeling, illustrating inadequate compliance with the NIH guidelines.81
For example, the results of a randomized clinical trial of coronary artery revascularization before elective vascular surgery in a sample of 98% men are generalized to all patients in the abstract, conclusion, accompanying editorial, and subsequent research summary.82–84
One has to question whether the identical study on a sample of 98% women would pass editorial review without including an acknowledgment of the study's limitations with the caveat that the results may not be generalizable to the men.
Even when women are included as subjects, the results in male subjects may take precedence in being generalized to the entire population. For example, Wing et al.85
published the results of a randomized, controlled trial comparing diuretics with angiotensin-converting enzyme (ACE) inhibitors for treatment of hypertension in older patients. Although ACE inhibitors showed a benefit for men in reducing the combined primary end point of cardiovascular events and all cause mortality, no difference was found for women, the group not only more likely to have hypertension but also the majority of the patient population in the age group studied. The wording of the results hid the absence of benefit of ACE inhibitors for women through misleading language extrapolating the results to “older patients, particularly men” in the abstract. The overreaching lead statement in the paper's discussion notes that “outcomes are better when hypertension in the elderly is treated with an ACE inhibitor.….” This continuation of gender bias in scientific reporting is scientifically unsound, potentially detrimental to the health of women, and antithetical to the emphasis on evidence-based practice promulgated in medical education.
Other goals of an expanded view of women's health were to broaden the inclusion of women's health topics in medical school curricula and establish clinical programs that promote comprehensive, interdisciplinary, integrated health services across the life span. OWH addressed this by moving beyond academic health centers, promoting five innovative national model programs at 48 different sites to advance (1) comprehensive, integrated, interdisciplinary, and coordinated women's healthcare, (2) healthcare professional and public education, (3) research on women's health, including sex and gender differences, (4) academic-community partnerships, and (5) leadership development for women.86
The five model programs include academic centers, community centers, and demonstration and rural health centers located across the United States. The hope was that the successes of these five models would encourage others to adapt a paradigm of comprehensive, multidisciplinary, integrated women's healthcare. Unfortunately, after 10 years of success and the development of a strong network of 48 sites across the United States, the CoE model has been defunded, with a number of sites in the middle of their contracts.
The progress of women's health content in medical school curricula was examined by Henrich.87
In support of stalled momentum in women's health, she found an increase in educational initiatives at the medical student and graduate training levels from 1995 to 2000 but no subsequent growth. Funding for women's health research has continually declined over the last 6 years. Federal funding from FY2004–2007 for NIH overall showed an increase of 0.5% and a zero dollar increase from 2006 to 2007. Similar trends have been seen for women's health research and other health programs, which either declined or saw a zero percent increase, failing to keep pace with inflation.88
When the percentage of NIH dollars given for the study of sex differences is analyzed, the grants awarded represent a very small percentage of the total number of grants allocated. Between 2000 and 2003, with the exception of a very few NIH centers where the percentage remained constant, the other centers and institutes showed a decrease of 1.5%–2% in the proportion of grants awarded that included a sex/gender comparison. The NIH institutes that fund the largest number of grants award a smaller percentage of those grants for the study of sex and gender differences.89
Women's health has also taken other unwanted steps backward, often as the result of a political agenda that has promulgated ideology over evidence. In 2005, the FDA decided not to allow emergency contraception (Plan B),90
often referred to as the “morning after pill,” to be available as an over-the-counter (OTC) product after two independent scientific panels recommended they do so. After 28 months of debate, the FDA indefinitely postponed its ruling on whether women should be allowed to buy emergency contraception without a prescription, opting instead to embark on a new regulation-writing process. After continued pressure from women's health activists and some members of Congress, in August of 2006, the FDA approved Plan B as an OTC option for women aged ≥18.91–93
The approval is a tribute to the efforts of reproductive rights and women's health advocates as well as the scientific community and policymakers who have fought to improve women's access to comprehensive healthcare. The triumph was only a partial victory, however, because young women <18 years of age still do not have easy access to emergency contraception. For these women, the drug still requires a prescription, a restriction unsupported by medical or scientific evidence. Requiring women <18 years of age to obtain a prescription delays access to an effective medication and makes intervention less effective.
Women on active duty in the military serve as another example of the setbacks in women's health. The 350,000 women currently serving in the U.S. military have limited to no access to emergency contraception at their military-based pharmacy and no access to elective termination of unwanted pregnancy care at their military health facility. In 2002, the Department of Defense approved Plan B to be stocked at military medical facilities, and Congress was to vote on a bill known as the “The Compassionate Care for Servicewomen Act” that would have added Plan B to the list of medications that must be stocked at every military health facility. The proposal never came to a vote.94
It has been acknowledged by all branches of the military and the Department of Veterans Affairs that women on active duty are at high risk of military sexual trauma. In the event that a woman soldier is raped, however, she is currently not guaranteed access to Plan B.
The attack in recent years on reproductive rights goes beyond access to safe and evidence-based contraception. Variations on bans to elective termination of pregnancy designed as a direct challenge to Roe v. Wade
were proposed in 12 states in 2006 alone. South Dakota became the first state in 15 years to pass a law making all elective termination of pregnancy illegal (a felony for the physician) unless the woman's life is endangered.95
Fortunately, a petition put forth to the South Dakota voters in November 2006 soundly defeated the ban.96
Similar laws were adopted in Louisiana and Utah in 1991 but were struck down in federal court. A federal ban on intact dilation and evacuation (the Partial-Birth Abortion Ban Act) was first enacted in 2003 and blocked from taking effect by three separate federal district court rulings, each upheld by a federal appeals court, as being unconstitutional, largely because of the absence of an exception to protect the health of the pregnant woman. In 2007, the U.S. Supreme Court issued a decision to uphold the federal ban. The setback to women's health is heralded by Justice Ginsburg, who wrote that the “decision is alarming.…. It tolerates, indeed applauds, federal intervention to ban nationwide a procedure found necessary and proper in certain cases by the American College of Obstetricians and Gynecologists (ACOG). It blurs the line, firmly drawn in Casey,
between previability and postviability abortions. And, for the first time since Roe,
the Court blesses a prohibition with no exception safeguarding a woman's health.”97
Many of the setbacks to women's health will impose real economic, physical, and emotional costs on women and their families. Decisions about funding women's health research and access to information, products, and services should not be made on political or ideological grounds but, to the extent possible, on sound medical evidence. To ensure that we have a body of scientific evidence on which to base such decisions, the sex-specific results of clinical research need to be reported and the limitation in generalizability must be acknowledged if research is done only in men.