Why we need FWH now
Women were categorically excluded from clinical research trials in the United States until 1993, when the NIH Revitalization Act became federal law, requiring women and minorities to be included as subjects of health research. Decades of exclusion of women as study subjects has resulted in a gross inequity that persists today. A particular scarcity exists in research of women of “child-bearing years,” which span the majority of a woman’s life –from menstruation to menopause– because of a faulty argument that it incurs a heightened liability. Men of reproductive potential have never been excluded from clinical research however, despite evidence that various treatments and drugs do impact the male reproductive system.
We must stop discounting women’s health concerns and start investing in the research required to address persistently unanswered questions.
Even though women consume approximately 80% of pharmaceutical products in the United States, in 1992 less than half of all prescription drugs had been analyzed for sex-related response differences.
Typical drug dosages for women are still based on men’s average weights and metabolisms, based on male-only drug trial data. The net effect of gender bias in pharmaceutical research is that women are at double the risk for adverse drug reactions than men. For example, some antithrombotic agents used to break up blood clots immediately after a heart attack, while beneficial to many men, may cause significant bleeding problems in women. Commonly prescribed drugs used to treat high blood pressure tend to lower men’s mortality from heart attack but have been shown to increase cardiac-related deaths among women.
Emerging evidence also suggests that the effects of antidepressants can vary over the course of the menstrual cycle. Subsequently, drug dosage may be too high at some points during estrous and too low at others. Drugs developed for men and untested on women may be dangerous for women, and drugs that are potentially beneficial to women may be eliminated in early phases of clinical testing when the test group does not include women and no benefits are manifest in male subjects.
We cannot rely on a public sector solution.
Women’s health research accounted for only 10.8% of the NIH budget in fiscal year 2023 despite the fact that women represent 51.1% of the American population. And NIH grants are prescriptive- they tell researchers what to study. We at FWH believe that RFPs should instead pose the question to the experts who know best what needs to be studied to produce the greatest impact. The impact of investing in women’s health research is staggering- for example, doubling the NIH budget for research on coronary artery disease in women from its current $20 million, could mean a shocking return on investment of 9,500%, and doubling the budget for research on rheumatoid arthritis in women would deliver a return on investment of 174,000%. Researchers can only pursue projects they can get funded, which is why private funders need to increase funding opportunities for women’s health research that have been grossly neglected by our government.
Women’s health research accounted for only 10.8% of the NIH budget in fiscal year 2020 despite the fact that women represent 51.1% of the American population. The impact of investing in women’s health research is staggering- for example, doubling the NIH budget for research on coronary artery disease in women from its current $20 million, could mean a shocking return on investment of 9,500%, and doubling the budget for rheumatoid arthritis in women would deliver a return on investment of 174,000%. Researchers can only pursue projects they can get funded, which is why private funders need to increase funding opportunities for women’s health research that are grossly neglected by our government.
Candidate study subjects that urgently require funding
Cardiovascular disease
Cardiovascular disease is the number one killer of women in the United States, yet only one-third of patients enrolled in clinical trials are female, and just 4% of the National Institutes of Health’s cardiac artery disease research budget focuses on women-only research. Research based on male subjects are extrapolated to women even though women bear a disproportionate burden of death and disability from cardiovascular disease in the United States.
Lung cancer
Lung cancer is the number one cancer killer of women in the United States, killing more women than breast cancer, ovarian cancer, and cervical cancer combined. Over the last 40 years, lung cancer incidence has dropped by 35% for men while it has risen by 87% for women, and yet in 2019 only 15% of the NIH lung cancer budget went to female-focused research. Multiple studies of lung cancer in women have indicated that there are differences in risk factors, histology, pathophysiology, treatment outcomes and prognosis as compared to men. Women are more likely than men to develop lung cancer when they have not smoked cigarettes. Research is needed to determine a way to identify women at high risk for lung cancer who have not smoked, and also for better screening methods that do not involve radiation.
Preeclampsia
There is no meaningful research on preeclampsia and its risk for future cardiovascular disease. Despite being the leading cause of maternal death, drug treatment to prevent preeclampsia is at best minimally effective, and current management therapies have significant limitations. In fact, at present, delivery is considered the only effective intervention for treating preeclampsia and even then, preeclampsia may continue in the postpartum period or present de novo.
Alzheimer’s
Only 12% of Alzheimer’s disease research goes to projects focused on women, even though women make up about 66% of all Alzheimer’s patients. While more research is needed, there has been evidence of sex-specific differences in the architecture of the brain that may speed the spread of tau, a protein that clumps into tangles and may contribute to cell death. These findings could lead to the creation of risk reduction strategies targeted to women.
Menopause
20 years ago, the NIH abruptly terminated research on the effect of hormone therapy on postmenopausal women and announced a link between menopausal hormone therapy (MHT) and increased risk of breast cancer and certain cardiovascular diseases. The decision resulted in a cascade of harm to millions who have undergone menopause in the United States. MHT prescriptions dropped from nearly 40% to roughly 5% among those experiencing menopause. It took more than a decade for the government data to be reassessed, the net result showing that the risks initially reported did not apply equally to younger women or to those whose last period was within the past 10 years. And the positive effects of MHT — including a decreased risk of diabetes, colon cancer and osteoporotic fractures, as well as a 30% percent decrease in death from all causes — never made it into the public discourse. Today, the American College of Obstetricians and Gynecologists, American Association of Clinical Endocrinologists and North American Menopause Society agree that MHT is a safe choice for the vast majority of healthy women with menopausal symptoms. Further research has shown the link to breast cancer to be minimal — statistically less than the risk incurred by working as a flight attendant or by drinking two glasses of wine at dinner nightly — and in the case of those who use estrogen only, there is a decrease in risk.
Premature ovarian failure
Premature ovarian failure (POF) has become one of the main causes of infertility in women of childbearing age and the incidence of POF is increasing year by year, seriously affecting the physical and mental health of patients and increasing the economic burden on families and society as a whole. The incidence of POF was documented as affecting 1% of women under 40, but has been rising and now affects more than 10% of women. At present there is no clear and effective treatment to restore the reproductive function of ovaries.
Endometriosis
Although several screening tools and tests have been proposed and tested to diagnose endometriosis, none are currently validated to accurately identify or predict individuals or populations that are most likely to have the disease. Endometriosis has significant social, public health and economic implications. It can decrease quality of life due to severe pain, fatigue, depression, anxiety and infertility. Some individuals with endometriosis experience debilitating pain that prevents them from going to work or school.