Increasing NIH funding for academic departments of obstetrics and gynecology: a call to action





The National Institutes of Health funding for reproductive sciences research, specifically in academic departments of obstetrics and gynecology, is disproportionately low. Research is one of the most important pillars in advancing healthcare. Despite US Congress’ vision in providing increased funding to the National Institutes of Health as a whole, underfunding for research in the departments of obstetrics and gynecology remains one of the several critical drivers in the decline in reproductive health and healthcare for women in the United States.


Introduction


Research is the driving force behind improving healthcare. In the United States, the National Institutes of Health (NIH) is the dominant funding source for health research. The US Congress recently increased funding for research, specifically the Ovarian Cancer Research Program (Department of Defense) and the NIH. Although this increase acknowledges the importance of research in healthcare for all areas, funding for reproductive sciences, which is primarily carried out in academic departments of obstetrics and gynecology (OBGYN), remains disproportionately low. This report reviews current underfunding for reproductive sciences research and highlights the urgent need for a call to action.


Funding to the departments of OBGYN represents a core inequity, with only 1% of the $14.3 billion in NIH funding designated to OBGYN departments in 2018. Although this represents an increase of $4 million from 2017, the increase in other subspecialties during the same time interval was more significant, with pediatrics, for example, receiving a $43 million increase. This differential in support affects research efforts in myriad ways but perhaps more significantly as it relates to the training pipeline. Developing a cadre of physician-scientists is essential, particularly as the number of women’s healthcare providers continues to decrease and because it is well recognized that physician-scientists are the driving force behind the research that will advance healthcare. In 2017, residents and fellows in OBGYN accounted for 4% of all trainees in the United States, whereas the same group in pediatrics was 7.5%. When comparing these numbers with overall funding, there was $30,122 of funding per OBGYN resident/fellow, compared with $80,246 for the same group in pediatrics.


The rate of funding is also disproportionate among institutes and centers within the NIH. The R-series research grants comprise the largest National Institute of Child Health and Human Development (NICHD) funding category. It includes independent research project grants (R01); small grants (R03); research enhancement awards (REA, R15); exploratory and developmental research project grants (R21); clinical trial planning grants (R34); and high-priority, short-term project grants (R56). In 2018, of the $16.2 billion in domestic funding assigned to the R-series projects, only $707.7 million (4.4%) was allocated to the NICHD, which funds both women’s health and pediatrics research. The K-series grants are career developmental training grants awarded to junior faculty to help them develop into independent investigators. Of the $732 million designated to K-series funding in 2018, only $49.2 million (6.7%) was earmarked to the NICHD. Although we support increased funding for all research at the NICHD, we advocate for a proportional increase in funding for academic departments of OBGYN specifically. Importantly, research in reproductive sciences would also benefit from increased funding to all institutes at the NIH that provide an opportunity for research in this important area: the National Heart, Lung, and Blood Institute; the National Institute of Diabetes and Digestive and Kidney Diseases; the National Institute on Drug Abuse; and the National Institute of Allergy and Infectious Diseases. In particular, the National Cancer Institute plays a vital role in supporting research for gynecologic cancers. However, there is a documented disparity of research funding for gynecologic cancers compared with other cancers. Although funding for research in reproductive sciences and women’s health does happen outside of OBGYN departments, the lack of clarity around defining research in both of these areas makes it extremely difficult to accurately assess the NIH funding. If one examines the NIH Research, Condition, and Disease Categorization Budget Estimating Tool Data Repository, the areas involved in the NIH total investment in women’s health–related research include diseases that are specific to or that predominately affect women and conditions that have an impact on both sexes. Focusing on academic departments of OBGYN leads to the realization that this subspecialty is at the heart of both women’s health and reproductive sciences research.


The quality of reproductive healthcare for women in the United States is declining. Maternal mortality rates are increasing; unintended pregnancy rates, while declining in the United States over the last decade, are still high among developed countries; and cervical cancer survival has not improved since the mid-1970s, unlike survival from other types of cancers. These poor outcomes, which disproportionately affect the underrepresented minority of women as well as women from low socioeconomic backgrounds, highlight the perilous state of women’s healthcare in the United States.


Increased federal funding to academic departments of OBGYN would not only improve women’s health but also mitigate the growing shortage of individuals committed to women’s reproductive health research. In 1992, the Institute of Medicine convened the Committee on Research Capabilities of Academic Departments of Obstetrics and Gynecology and reported that the “level of support for the next generation of investigators is not sufficient to sustain, let alone expand, existing research capabilities.” These investigators serve as an essential link between scientific discovery, clinical implementation, and practice. A study by the Association of American Medical Colleges found that investment in physician-scientists is critical to the sustainability of the current workforce. The scientific impact that comes from strengthened research efforts has a profound and direct effect on significant discoveries, advancement in healthcare technologies, development of new treatments, and improvement in healthcare and public health. To invest in the improvement of reproductive health, policy makers need to ensure that the substantial increases in federal funding for biomedical research are occurring for women’s health research programs as well. The fiscal year (FY) 2021 appropriations process is the right time for policy makers to examine this inequity in research funding for women’s health at all levels and address it with the NIH and its institutes ( Table 1 ).



Table 1

Major asks

















Separate institute for research on the reproductive health of women.
Transparency and accountability in measuring spending on reproductive health of women.
Focus on diseases that affect only women and the hormonal milestones that are unique to women.
Focus on reproduction beyond pregnancy.
Focus on pregnancy-related causes of infant mortality.
Sponsor/host a conference to identify the most critically underfunded reproductive science issues that could impact public health.
Increase funding for research in gynecologic oncology.

Rice. Call to action for increasing NIH funding for academic OBGYN departments. Am J Obstet Gynecol 2020 .


Maternal-fetal medicine


A key component of OBGYN research is inquiry into the biology of pregnancy and its implications for the health of populations. Common diseases during pregnancy, such as preeclampsia, preterm birth, and fetal growth restriction, can have a devastating impact on the mother and the fetus, and racial disparity also affects the treatment of these mothers and their fetuses. Unfortunately, maternal-perinatal mortality has increased since the Centers for Disease Control and Prevention Pregnancy Mortality Surveillance System was implemented in 1987. Moreover, the incidence of infant mortality has not seen a significant decline, and the burden of diseases related to these conditions continues to disproportionately affect underserved populations. Unique to pregnancy, illnesses during early human development shape fetal programming, putting one at an increased risk of developing neurobehavioral disorders and other chronic diseases during childhood and metabolic syndrome in adulthood. Recent investigations have also illuminated the impact of perinatal diseases on maternal health years after pregnancy. Considering the nearly 4 million annual deliveries in the United States, it is clear that perinatal diseases may take a major toll on our healthcare system and economy.


Research in early human development and perinatal medicine has not been prioritized. Obstetrics is uniquely poised to expand developmental research and explore appropriate interventions. The Barker hypothesis states that increases in diabetes, obesity, and hypertension are related to suboptimal gestation. Pregnancy research remains at the basic and clinical level relatively underfunded by the NIH. Based on the NIH’s Estimates of Funding for Various Research, Condition, and Disease Categories, which includes grants and other funding mechanisms, the NIH budget distributions of $419 million in 2018 were allocated to pregnancy research, representing less than 1.2% of the total NIH budget for that year. These data represent an alarming underestimation of disease burden related to pregnancy. We should not forget that although only approximately 1% of the US population is pregnant, pregnant women carry 100% of the future of humankind.


Gynecologic oncology


Gynecologic malignancies including ovarian, cervical, and endometrial cancers are a major cause of morbidity and mortality in women. In 2019 alone, it was estimated that there would be 109,000 new cases of gynecologic malignancies and that more than 33,000 women will die from these malignancies. Ovarian cancer is one of the most deadly cancers in women. There is still no screening test for this malignancy, which results in a majority of women being diagnosed at an advanced stage. Uterine cancer rates are increasing and continue to disproportionately affect African American women who have a concomitant higher mortality compared with white patients. African American women have a 2-fold increased risk of dying of uterine cancer compared with white women. Similarly, cervical cancer disproportionately affects vulnerable populations. Despite the availability of effective screening and an efficacious vaccine, more than 10 women in United States die every day from cervical cancer. Furthermore, outcomes for many gynecologic cancers have improved little over time. Of all the common cancer cases in the United States, cervical and uterine cancers are the only 2 malignancies that had a decrease in 5-year survival from the early to mid-1970 to 2013.


Despite the public health impact of gynecologic cancers, research efforts directed toward these malignancies have lagged far behind those for other malignancies. The NIH funding for uterine cancer was only $57,000 per person-years of life lost per 100 new cases, compared with more than $1.8 million for both breast and prostate cancers. When adjusted for changes in mortality, the average NIH funding for cervical, uterine, and ovarian cancers have all decreased from 2007 to 2014. These data clearly demonstrate the limited resources allocated to these malignancies compared with other cancers.


Family planning


Use of family planning services, defined as contraception and abortion care, is common among women in the United States. An estimated 99% of women aged 15 to 44 years, who have ever had sexual intercourse, have used contraception. An estimated 24% of women in the United States have at least 1 abortion by the age of 45 years. The average American woman spends 75% of her reproductive life avoiding pregnancy and about 3 years being pregnant.


Documented benefits of using family planning services are numerous and include improved maternal, infant, and child health outcomes , ; achievement of desired family size ; and positive impacts on women’s education and workforce participation. In addition, hormonal contraception has many benefits outside of family planning and can be a treatment for excessive menstrual bleeding, menstrual pain, and acne. Systemic and intrauterine hormonal contraceptions are also associated with decreased risks of uterine, ovarian, and cervical cancers. However, these benefits are not available to all, as there are persistent and devastating inequities in accessing family planning associated with race and class. ,


Despite how common family planning is and how much impact it can have on the health of women, children, and families, research on family planning is woefully undersupported. Only 296 (0.4%) of 739,679 grants the NIH supported in 2018 were related to family planning. This leads to thinly dispersed distribution of funds for research innovations in safety, efficacy, access, and use of treatment and the impact of denied, inadequate, or delayed access to family planning care. Research in this area informs clinical practices that improve quality of reproductive care for all women. For example, an NICHD R01 award allowed Schreiber et al to demonstrate that pretreatment with mifepristone resulted in a higher likelihood of successful nonsurgical management of first-trimester pregnancy loss than treatment with misoprostol alone. This research directly affects the estimated 1 million American women who have miscarriage each year. Furthermore, research in this arena is crucial in combating non–evidence-based policy focused on limiting access to reproductive healthcare.


Female pelvic medicine and reconstructive surgery


Approximately 25% of adult women in the United States report 1 or more pelvic floor disorders (PFDs), including issues such as urinary incontinence, fecal incontinence, and pelvic organ prolapse. The overall prevalence is even higher in women older than 65 years. PFDs can have profound effects on a woman’s quality of life by affecting physical function, sexual function, and social interactions. Despite our knowledge that obesity, childbirth, and prior hysterectomy are associated with higher odds of PFDs, few preventative strategies exist. This barrier, coupled with an aging population, leads to a significant burden on our healthcare system.


Funding for PFD research has decreased significantly over the last decade. Based on a review of the NIH awards across multiple institutes, $18.5 million was allocated to PFD research in 2009 with a decrease to $13 million in 2019, representing a 30% decrease in overall funding. This occurred despite the fact that surgical management for many of these disorders has increased. , To put funding disparities into perspective, a woman’s lifetime risk of developing prolapse is 12.6%, which parallels the 11.6% lifetime risk of a man developing prostate cancer. Yet, the $13 million in funding for pelvic floor research represents less than 5% of the $271 million that was allocated to prostate cancer research in 2019.


Recent controversies in the surgical management of pelvic organ prolapse highlight the consequences of shrinking resources for PFD research. In an effort to provide more durable surgical outcomes for women with prolapse, a group of surgeries were developed that used permanent mesh placed through vaginal incisions. These surgeries, termed “vaginal mesh for prolapse (VM),” are performed differently than the gold standard mesh reinforcement surgeries for prolapse and have different outcomes. Unfortunately, VM surgeries were developed in a climate of limited funding for clinical trials and without rigorous testing in women before large-scale use. There was a dramatic increase in VM surgeries between 2005 and 2010, with unintended consequences of higher-than-expected complications. These complications included mesh erosions, dyspareunia, chronic pelvic pain, and organ perforation with 7 reported deaths over a 2-year period. This led to a series of communications to physicians and patients from the US Food and Drug Administration and, ultimately in 2019, a cessation of manufacturing of these products. These events highlight how a lack of investment in research on biomechanics, biomaterials, and treatment of prolapse led to harm for many women in the United States and other parts of the world. Given that PFDs are more common than many other healthcare issues, we emphasize that significantly more resources should be devoted for the prevention and treatment of these issues.


Reproductive endocrinology and infertility


Women are unique in the universal loss of reproductive function long before other vital systems fail. Little is known about the determinants or correlates of ovarian aging or the health implications, especially in diverse communities. In a previous study of applications submitted to the NIH from 2011 to 2015, those identified by key words “ovary,” “reproductive,” and “fertility” were the least successful, with only 7.5% receiving funding, compared with 28.9% in the most favored tier, ascertained by the application’s scientific and technical merit as assessed by the reviewers. In addition, women have unique biological experiences, including menarche, menstrual cyclicity, pregnancy, and menopause, that affect lifelong health. Throughout reproductive life and beyond, these experiences remain underexplored and likely contribute to significant morbidity and mortality.


Other examples of underfunding in reproductive endocrinology and infertility include endometriosis, a disease affecting about 10% of reproductive-age women. Despite its high prevalence, this disease received only $7 million funding in FY 2018, putting it near the very bottom of NIH’s 285 disease and/or research areas. Similar in terms of prevalence, polycystic ovary syndrome (PCOS), a complex, multisystem disorder, did not even make the list, suggesting <$500,000 funding annually. Increasing the NIH funding in this subspecialty would affect women of all ages. For example, the NICHD funded a multicenter trial comparing clomiphene citrate with letrozole in ovulation induction for women with PCOS, which changed decades of practice in infertility for the most common endocrinopathy in reproductive-age women.


Conclusion


Reproductive sciences research funding has been an area of major concern for the NIH for decades. Although the Office of Research on Women’s Health, for the last 25 years, has dedicated itself to promoting all of women’s health research, including reproductive sciences, they have faced challenges. Despite a tremendous effort to increase enrollment of women in NIH-funded clinical trials, it continues to be a problem needing attention from policy makers. Data published in 2015 show that only 26% of NIH-funded clinical trials reported at least 1 outcome by sex or explicitly included sex as a covariate in statistical analysis. Support for research conducted in academic departments of OBGYN needs special attention from policy makers during the FY 2021 federal government funding process. OBGYN is the bedrock of women’s health and affects the health of families and communities. Data support that healthier women have healthier children and significantly affect and create more productive and better educated communities. In the study by Onarheim et al, improvement in the health status of women was associated with longer-term financial productivity and demonstrated that intentional investments in family planning and healthier mothers before and after pregnancy led to positive societal development. The United States falls significantly behind other developed nations in multiple areas of women’s health. Evidence-based research is critical in enhancing the lives of girls and women. As women’s health experts, we are advocating for increased NIH funding for research in the field of OBGYN. The Women First Research Coalition, 13 member organizations ( Appendix ) supported by the American Gynecological and Obstetrical Society, represents academic and public policy leaders from across multiple disciplines of OBGYN. The Coalition is committed to working with national policy makers to address this vitally important issue affecting all women in the United States ( Table 2 ).


Aug 9, 2020 | Posted by in GYNECOLOGY | Comments Off on Increasing NIH funding for academic departments of obstetrics and gynecology: a call to action

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