The Default Male

How Male-Centric Medicine Leaves Women Misdiagnosed and Undertreated

1. Opening: The Patient Who Waits

In October 2026, Nature Medicine published a harmonized analysis of self-reported pain covering 6,125,459 people aged 5 to over 100, drawn from 902 population-based data sources in 118 countries and territories between 1990 and 2025 [1]. Women reported more pain than men across all 11 anatomical sites examined. The gaps were widest for facial pain, headache, and abdominal pain, where women’s reported prevalence was roughly 83, 74, and 60 percent higher [1].

The study measures reported prevalence. It cannot apportion the observed difference among biology, social experience, and measurement artifacts, and it says nothing about how clinicians respond; its data are largely cross-sectional and unevenly distributed across regions [1]. Biological sex (genetic, cellular, and endocrine physiology) and gender-related factors (social roles, care-seeking behavior, clinical interactions, and access barriers) can each contribute, and their relative weight differs by condition [2]. Whether healthcare systems treat women differently once they seek care is a distinct question, answerable only through studies of clinical assessment, diagnosis, and treatment. Those studies form the subject of this article.

The clinical consequences are visible in conditions such as endometriosis, where systematic reviews report average delays of several years between symptom onset and diagnosis, with wide variation across settings and definitions [3, 4].

What “default male” means here. The phrase does not claim that women were never studied. It refers to four distinct problems, which affect different conditions to varying degrees:

Exclusion or under-enrollment: women left out of, or thinly represented in, particular research settings.
Male-dominated preclinical models: a prolonged reliance on male animals and cell lines.
Untested or unreported sex effects: studies that enroll women but do not examine whether results differ by sex.
Uncorrected clinical standards: symptom templates, diagnostic thresholds, and doses built on that evidence and never recalibrated.

How the article is organized. Evidence can be lost at four stages: research design determines what is investigated; analysis determines whether differences are detected; clinical translation determines whether findings change practice; and funding governance determines whether identified gaps are addressed. The four stages describe where evidence is lost. The five gaps below are the article’s subject areas, and each maps onto one or more stages:

The research gap (stages 1 and 2): historical underrepresentation in basic, preclinical, and clinical research (Section 2).
The diagnostic gap (stage 3): clinical criteria and thresholds that fail to capture non-classical presentations (Sections 3 and 4).
The treatment gap (stage 3): uncalibrated pharmacokinetics and sex-associated drug toxicity (Section 5).
The funding gap (stage 4): funding allocations detached from documented disease burden (Section 6).
The accountability gap (all four stages): inclusion and policy frameworks that fail to alter routine clinical care (Sections 7 and 8).

2. How Male Became the Default

The claim that medical science has always studied only men is historically inaccurate. Women have taken part in research across many fields, and representation has improved. A 2022 systematic review and meta-analysis by Daitch and colleagues evaluated 300 randomized controlled trials published in 2017 across six diverse clinical fields [5]. Among the 289 trials that reported participant sex, the overall median female enrollment was 41 percent (interquartile range 27 to 54 percent) [5]. Within that sample, enrollment varied considerably across disease categories: in the subset of 17 trials evaluating ischemic heart disease, the median female enrollment was 22 percent (interquartile range 17 to 33 percent), the lowest among the examined conditions, whereas trials of immune system diseases enrolled a median of 68 percent women (interquartile range 46 to 81 percent across 12 trials) [5]. This 22 percent figure reflects the ischemic heart disease subset in that sample rather than an aggregate rate across all cardiovascular subspecialties.

In the United States, NIH monitoring has long shown women making up roughly half or more of enrollees in aggregate; the Government Accountability Office reported 57 percent for fiscal year 2014 [6]. Aggregates of this kind can easily conceal disease-specific underrepresentation: high enrollment in female-specific conditions, psychiatric disorders, or musculoskeletal cohorts masks persistent shortfalls in cardiovascular and oncological trials. Aggregate enrollment figures also say nothing about whether a trial was powered or analyzed to detect sex differences. The same GAO report found that NIH did not record whether trials planned to analyze results by sex [6].

The historical research problem has three parts: the exclusion of women of childbearing potential from early-phase drug research, the prolonged reliance on male animal and cellular models, and the persistent gap between numerical representation and sex-stratified analysis [2, 7, 8].

Human trials. In September 1977, the FDA issued its administrative guideline General Considerations for the Clinical Evaluation of Drugs (FDA 77-3040) [7]. The document advised that women of childbearing potential should generally be excluded from Phase I and early Phase II studies until animal reproductive toxicity and fertility studies were completed and preliminary evidence of efficacy had been obtained, providing an explicit exception only for investigations of life-threatening conditions [7]. The guideline defined a woman of childbearing potential as any premenopausal female physiologically capable of pregnancy, an administrative categorization designed to avoid potential fetal exposure [7]. While the document constituted agency guidance rather than statutory prohibition, it established a formal FDA precedent for restricting participation in early-phase trials [7]. In October 1988, the FDA published guidance requesting that sponsors present safety and effectiveness data by sex, age, and race in new drug applications. On 22 July 1993, the FDA formally published its Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs in the Federal Register (58 FR 39406) [7]. The 1993 guideline superseded the earlier restrictive approach and encouraged the inclusion of women and the evaluation of clinically meaningful sex differences, ending the blanket presumption of exclusion while recognizing that removing formal prohibitions did not instantly eliminate commercial recruitment barriers [7].

Preclinical science. In basic laboratory science, female rodents and female-derived cell cultures were long excluded under the working assumption that cyclical hormonal fluctuations during the estrous cycle would introduce unmanageable experimental variance [2, 8]. A 2020 meta-analysis by Zajitschek and colleagues evaluated 218 traits across more than 26,900 mice, testing that assumption against the evolutionary “greater male variability” hypothesis [8]. The analysis showed that trait variability was sexually dimorphic in a trait-specific manner: male mice exhibited greater variability in morphological traits, whereas female mice exhibited greater variability in immunological traits [8]. These findings indicate that hormonal cycling does not justify blanket exclusions of female animals in preclinical research. Concurrently, the authors noted that their results do not imply that every biological experiment must automatically include both sexes regardless of the underlying hypothesis; rather, experimental designs should consider biological sex where scientifically relevant and incorporate appropriate statistical models for trait variance [8].

Policy responses, and what each does and does not require.

1993 NIH Revitalization Act (Public Law 103-43). Signed on 10 June 1993, it directed NIH to establish guidelines for including women and minorities in clinical research and, for NIH-defined Phase III trials, to design trials so that they permit valid analysis of whether interventions affect women or minorities differently [9].
2016 Sex as a Biological Variable (SABV) policy. NIH expects sex to be factored into research design, analysis, and reporting in vertebrate animal and human studies, and grant applications proposing a single sex require strong scientific justification [10].
Statutory trial registration and demographic reporting (FDAAA 801 and 42 CFR Part 11). Under Section 801 of the Food and Drug Administration Amendments Act of 2007 and its implementing regulation (42 CFR Part 11, effective January 2017), sponsors of applicable clinical trials (which include most interventional studies of FDA-regulated drugs, biologics, and devices, excluding Phase 1 drug trials and small device feasibility studies) must register and submit summary results data within one year of primary completion [11, 12]. Under 42 CFR § 11.48, these submissions mandate the reporting of participant baseline demographic characteristics, including data disaggregated by sex [11]. The statutory reporting requirement establishes public transparency about trial participation; by itself, it does not require sex-stratified statistical analyses of efficacy or safety outcomes [11]. Other applicable regulatory, funding, or policy requirements may impose additional obligations.
NIH Phase III valid-analysis policy. NIH’s inclusion policy requires investigators proposing NIH-defined Phase III clinical trials to assess prior evidence about clinically important differences in intervention effects by sex and race or ethnicity. Where prior evidence supports meaningful differences, trial design must accommodate those differences; where evidence is inconclusive, the trial must permit valid analysis, without requiring high statistical power for every subgroup comparison. Where prior evidence strongly supports no clinically important differences, subgroup inclusion and analysis remain encouraged, but the requirements differ [9, 12, 13]. For NIH-defined Phase III applicable clinical trials, results of valid analyses must be submitted to ClinicalTrials.gov as required by NIH policy. The broader NIH policy also specifies progress-reporting and analysis obligations according to the applicable evidence category [12, 13].
July 2025 revision of the NIH inclusion policy. Notice NOT-OD-25-131, issued on 17 July 2025 and effective on 16 August 2025, revised the policy to align with Executive Order 14168, replacing “sex/gender” with “sex” and referencing updated federal data standards for race and ethnicity [13]. Crucially, the notice specifies that while the policy framework references updated Office of Management and Budget standards, award recipients must continue using the established 1997 reporting categories for NIH inclusion enrollment reports until the agency issues updated technical implementation instructions [13]. The core statutory mandate requiring valid analyses in NIH-defined Phase III trials was retained in full, operating alongside, and remaining distinct from, the separate 2016 SABV research-design policy [10, 13].

Numerical parity in enrollment does not guarantee that a study can detect meaningful sex differences. Inclusion can improve clinical evidence only when recruitment is appropriate to the research question, analyses address plausible or previously supported differences, results are reported transparently, and findings inform guidelines and drug labels where warranted. When studies pool female and male data without appropriate analysis of potentially meaningful differences, sex-specific therapeutic windows and safety profiles may remain obscured [2].

3. When the Evidence Misses the Patient: Cardiovascular Disease

Cardiovascular disease is the leading cause of death among women globally, accounting for approximately 35 percent of all female deaths worldwide in 2019 according to the Lancet Women and Cardiovascular Disease Commission, with broader global mortality context provided by the World Health Organization [14]. The clinical evidence behind its diagnosis carries two distinct challenges: whether disease is recognized during clinical presentation, and whether diagnostic measurements are calibrated to female physiology.

These two diagnostic challenges can intersect in clinical practice. When non-chest symptoms lead clinicians to assign lower initial triage priority, diagnostic evaluation may be delayed. If subsequent testing relies on diagnostic thresholds or imaging protocols optimized primarily for obstructive epicardial coronary disease, non-obstructive or microvascular ischemic presentations may remain unrecognized. While clinicians hypothesize that these diagnostic challenges compound one another, the empirical literature examines each phenomenon through distinct studies rather than a single unified causal sequence.

Problem one: recognition

Chest discomfort is the most common symptom of acute coronary syndrome in both women and men. Multiple observational studies, however, report that women more often describe accompanying or predominant non-chest symptoms, including shortness of breath, nausea, unusual fatigue, dizziness, and pain in the back, neck, or jaw [15].

In February 2026, the American Heart Association published a scientific statement on acute coronary syndromes in premenopausal women [16]. The statement describes younger women as an under-recognized patient cohort who have traditionally been viewed as protected by endogenous estrogen. While obstructive atherosclerosis remains the most frequent finding, non-atherosclerotic mechanisms occur more frequently than in older cohorts or age-matched men, including spontaneous coronary artery dissection (SCAD), epicardial coronary spasm, and coronary thromboembolism [16]. The statement also highlights myocardial infarction with non-obstructive coronary arteries (MINOCA) as a working clinical diagnosis (defined by acute myocardial infarction without angiographically obstructive coronary stenosis of 50 percent or greater), which encompasses both atherosclerotic processes, such as plaque erosion, and non-atherosclerotic mechanisms [16]. Younger women experience delays in seeking and receiving emergency diagnosis, less often receive guideline-directed medical therapy after an acute coronary syndrome, and exhibit worse clinical outcomes than age-matched men [16]. Standardized diagnostic and management pathways specifically tailored for premenopausal women have not yet been established in routine practice [16].

The evidence base that guides cardiovascular care reflects a persistent leadership gap. A 2025 systematic review of 1,079 cardiovascular trials registered between 2017 and 2023 found women made up 41 percent of enrollees overall, but female-to-male ratios were significantly lower in trials of arrhythmia, coronary heart disease, acute coronary syndrome, and heart failure [17]. Trial governance shows a corresponding disparity. A systematic review and meta-analysis by Samimi and colleagues in JACC: Advances (2026) evaluated high-impact interventional structural heart disease trials published between 2010 and 2025 [18]. Among 88 eligible trials, 67.8 percent (60 trials) reported an oversight steering committee, and 55.8 percent (49 trials) disclosed committee member names [18]. Across committees with available membership data, women held only 7.0 percent of committee seats, and 56.2 percent of committees were composed entirely of men; across the evaluated trials, women served as committee chairs in 12.0 percent of trials [18]. Representation did not improve significantly over the 15-year period. While this review evaluates one specific interventional subspecialty and does not prove that leadership composition causes enrollment patterns, it illustrates the ongoing scarcity of women in trial design and executive governance within that field.

Problem two: measurement thresholds

A prospective cohort study published in The BMJ by Shah and colleagues tested a high-sensitivity cardiac troponin I assay with sex-specific thresholds (34 ng/L for men, 16 ng/L for women) against standard clinical practice using a contemporary assay with a single 50 ng/L threshold in 1,126 consecutive patients presenting with suspected acute coronary syndrome [19]. Under the contemporary assay (50 ng/L threshold), 11 percent of women in the cohort met the diagnostic criteria for myocardial infarction. When evaluated with the high-sensitivity assay using sex-specific diagnostic thresholds (16 ng/L for women), the proportion of women diagnosed with myocardial infarction rose to 22 percent, whereas the proportion among men increased modestly from 19 to 21 percent [19].

Two methodological cautions apply to these findings. First, the comparison changed both the assay technology and the thresholds. When the authors applied a single generic threshold (26 ng/L) to the high-sensitivity assay, 16 percent of women met the diagnostic threshold, demonstrating that part of the diagnostic reclassification stemmed from increased analytical assay sensitivity and part from sex-specific threshold calibration [19]. Second, biomarker elevation directly measures circulating cardiac troponin released during myocardial necrosis or injury, which clinicians integrate with symptoms and electrocardiographic findings to establish an adjudicated diagnosis of myocardial infarction. This observational cohort design demonstrated that sex-specific thresholds alter diagnostic classification; it did not evaluate whether identifying these additional patients translated into improved long-term clinical outcomes [19]. The authors identified that outcome question as requiring dedicated prospective testing.

4. Years Without a Diagnosis: Endometriosis and Chronic Pain

Endometriosis, characterized by the growth of endometrial-like tissue outside the uterus, causes chronic pelvic pain, dyspareunia, and infertility. It exemplifies how diagnostic delay, symptom normalization, and evidence gaps converge in chronic female conditions [3, 4].

The observed outcome. A 2024 scoping review of diagnostic delay by Fryer and colleagues documented an average delay from symptom onset to diagnosis of 6.8 years across included studies, with study-level averages ranging from 1.5 to 11.4 years [3]. A 2025 systematic literature review in BJOG examining 17 observational publications reported documented diagnostic intervals ranging from 0.3 to 12 years in the literature, with typical average delays between 7 and 10 years across various international cohorts [4]. Both reviews emphasize that diagnostic delay is heavily influenced by how the interval is defined: whether researchers measure time from initial symptom onset, first presentation to primary care, or definitive surgical laparoscopy.

The proposed explanations. The reviews’ causal interpretations must be distinguished from the measured delays. The scoping review notes that patients frequently reported feeling dismissed or disbelieved by healthcare professionals, concluding that provider education, systematic outcome tracking, and non-invasive diagnostic biomarkers are needed [3]. The BJOG review suggests that clinical gatekeeping and diagnostic inertia in primary care represent primary drivers of delay, calling for standardized diagnostic definitions and earlier specialist referral [4]. These observational findings identify plausible institutional contributors; they do not isolate a single causal mechanism.

Three questions about pain, and what answers each.

Does reported pain differ in prevalence? Yes. The October 2026 Nature Medicine analysis documents higher self-reported pain prevalence in women across all 11 anatomical sites evaluated in 6.1 million individuals, demonstrating a consistent disparity in symptom burden [1].
Are patients assessed differently when they present with acute pain? A prospective cohort study by Chen and colleagues in Academic Emergency Medicine evaluated 981 consecutive adults presenting with acute abdominal pain to an urban emergency department [20]. Despite presenting with virtually identical mean pain scores, women were 13 to 25 percent less likely than men to receive opioid analgesia after adjusting for age, race, triage class, and pain severity, with no difference in non-opioid administration [20]. Women also experienced significantly longer waiting times for analgesia: a median of 65 minutes compared to 49 minutes for men (difference 16 minutes; 95 percent confidence interval 3.5 to 33) [20]. The authors suggested gender-based clinical perception as a possible contributor. However, this was a single-center study conducted two decades ago; it demonstrates an operational disparity in emergency analgesia without establishing its underlying cause.
Does differential assessment lead to poorer long-term health outcomes? The existing cross-sectional and acute observational studies do not answer this question. Establishing whether delayed or withheld analgesia produces long-term clinical harm requires dedicated prospective longitudinal research.

5. The Wrong Dose, or the Wrong Evidence? Pharmacology and Drug Safety

Prescribing practices have historically treated women as smaller men, adjusting dosages solely by body weight rather than evaluating distinct pharmacokinetic and pharmacodynamic profiles. A 2020 review by Zucker and Prendergast evaluating 86 FDA-approved drugs with available sex-specific pharmacokinetic data argued that weight-based scaling fails to account for fundamental sex differences in drug absorption, distribution, metabolism, and excretion [21].

Zolpidem: a case in which evidence changed a dose. On 10 January 2013, the FDA issued a Drug Safety Communication requiring manufacturers of zolpidem to lower the recommended starting dose for women: from 10 mg to 5 mg for immediate-release formulations, and from 12.5 mg to 6.25 mg for extended-release formulations [22]. The agency also advised prescribers that lower doses should be considered for male patients [22]. Pharmacokinetic evaluations from abbreviated new drug application studies revealed that approximately 15 percent of women, compared to only 3 percent of men, had serum zolpidem concentrations of 50 ng/mL or higher 8 hours after a 10 mg immediate-release dose [22, 23]. For the 12.5 mg extended-release formulation, roughly 33 percent of women and 25 percent of men exceeded that concentration at 8 hours [22, 23]. The FDA treated 50 ng/mL as clinically significant because laboratory psychomotor tests and driving-simulation models indicated impaired performance at or above this threshold [22, 23]. Subsequent pharmacologic literature, notably by Greenblatt and colleagues, noted that direct epidemiological correlation between this specific blood concentration and motor vehicle collision records was limited [23].

The zolpidem intervention illustrates that sex-related pharmacokinetic divergence can generate real-world safety risks. However, this case does not imply that all pharmaceuticals require lower female doses. Drug exposure depends on formulation, genotype, age, organ function, and concurrent medications; average sex-associated differences describe population distributions and do not dictate individual therapeutic doses [21, 23].

Adverse reactions across drugs. In their analysis of 86 FDA-approved drugs for which sex-specific pharmacokinetic data were available, Zucker and Prendergast found that women exhibited significantly higher pharmacokinetic exposure (higher maximum serum concentrations or area under the curve) or longer elimination half-lives for 76 compounds (88 percent of the examined drugs) [21]. Among the 59 drugs in that sample that had clinically documented sex-biased adverse event records, elevated female pharmacokinetic exposure correctly predicted the direction of female-biased adverse drug reactions in 88 percent of cases (52 of 59 drugs) [21]. Within the clinical literature surveyed across those drug classes, the authors noted that women experienced adverse drug reactions at rates nearly twice those of men [21]. Because this analysis examined a selected subset of therapeutics with published sex-specific pharmacokinetic data, these proportions reflect relationships within that documented cohort rather than an established universal effect size across all marketed pharmaceuticals.

A clear class-specific example involves antiseizure medications. A 2021 systematic review and meta-analysis by Alfares and colleagues in CNS Drugs found that women faced a significantly higher risk of cutaneous adverse drug reactions to antiseizure medications (pooled odds ratio 1.76, 95 percent confidence interval 1.55 to 1.99; seven observational studies, 223,209 patients) [24]. The association was particularly pronounced for lamotrigine (odds ratio 2.17) and carbamazepine (odds ratio 1.63) [24]. The review evaluates observational data in one therapeutic category; the authors emphasized that the underlying pharmacogenetic and immunologic mechanisms require further mechanistic study.

These findings highlight two practical regulatory priorities: determining when pharmacokinetic evidence warrants sex-differentiated dosing guidance on drug labels, and establishing post-marketing surveillance capable of detecting class-specific safety signals. Translating pharmacokinetic differences into actionable clinical guidance remains an essential public health objective.

6. Who Funds the Missing Answers? Research Funding and Economics

The NIH funding share

In its congressionally mandated evaluation, A Vision for Women’s Health Research: Transformative Change at the National Institutes of Health (released in December 2024 and published in its final edition in 2025), the National Academies of Sciences, Engineering, and Medicine (NASEM) evaluated NIH extramural grant funding across fiscal years 2013 through 2023 [25, 26]. The committee defined women’s health research as studies focusing on conditions that uniquely affect women (such as gynecological and obstetric conditions), differently affect women (such as female presentations of cardiovascular disease), or disproportionately affect women (such as autoimmune disorders, chronic pain, and osteoporosis) [25]. Under this categorization, women’s health research accounted for 7.9 percent of total NIH grant funding in fiscal year 2023, down from 9.7 percent in fiscal year 2013, averaging 8.8 percent across the 11-year study window, even as the total NIH budget expanded [25, 26].

These figures require careful contextual reading:

The metric reflects the committee’s specific classification. It does not mean that the remaining 92.1 percent of NIH grant funding excluded women. Substantial research on conditions affecting both sexes, such as oncology and neuroscience, generates findings directly relevant to female patients.
The classification methodology is disputed. In an official December 2024 response, the NIH argued that the report failed to capture the full breadth of its women’s health portfolio and overlooked statutory language that places primary responsibility for gynecological and pregnancy-related research within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) [27].
A funding ratio alone cannot establish institutional bias. Efficient grant allocation depends on multiple competing factors, including disease burden, scientific feasibility, cost structures, and investigator applicant volume.

A decision framework rather than a single ratio

The NASEM committee recommended that the NIH and Congress establish annual funding benchmarks aligned with disease burden, report annually to Congress on progress toward those benchmarks, and consider establishing a dedicated National Institute on Women’s Health [25, 26]. However, disease burden represents only one dimension of research governance. A comprehensive capital allocation framework evaluates five distinct criteria, distinguishing between quantitative metrics and qualitative judgments:

Disease burden: measured quantitatively through population prevalence, mortality rates, and disability-adjusted life years (DALYs).
Unmet clinical need: evaluated semi-quantitatively through the availability and efficacy of existing diagnostic tools and therapeutic regimens.
Scientific opportunity and feasibility: evaluated through expert judgment of methodological tractability, available animal models, and clinical trial infrastructure.
Historical underinvestment: assessed quantitatively by reviewing cumulative grant allocations over past decades relative to population disease burden.
Therapeutic potential: evaluated through expert assessment of whether incremental grant investment is likely to yield disease-modifying clinical interventions.

A low funding share signals institutional neglect when disease burden and unmet clinical need are high while scientific feasibility is demonstrable. The NASEM committee specifically identified endometriosis, polycystic ovary syndrome, and uterine fibroids as conditions characterized by high burden, severe unmet need, and documented research underinvestment [26].

The economic estimates

In January 2024, the World Economic Forum (WEF) and the McKinsey Health Institute published Closing the Women’s Health Gap: A $1 Trillion Opportunity to Improve Lives and Economies [28]. The report modeled a hypothetical scenario in which health disparities between women and men are eliminated by 2040, based on an estimate that women spend 25 percent more of their lives in debilitating health. The authors calculated that resolving this disparity could avert 75 million disability-adjusted life years globally each year and potentially generate at least $1 trillion annually in global gross domestic product by 2040, an economic output modeled as equivalent to roughly 137 million women participating in full-time employment [28]. Approximately 50 percent of the health burden and 80 percent of the modeled economic effect in this scenario occurs during prime working years (ages 20 to 64) [28].

In January 2025, a follow-up blueprint evaluated nine specific conditions: breast cancer, cervical cancer, menopause, endometriosis, premenstrual syndrome, postpartum hemorrhage, maternal hypertensive disorders, migraine, and ischemic heart disease [29]. Modeling the elimination of disparities across these nine conditions estimated that nearly 27 million DALYs could be averted annually, potentially contributing roughly $400 billion per year to global GDP by 2040 [29].

These economic projections must be interpreted with three essential caveats:

They are non-additive. The nine conditions analyzed in 2025 represent a subset of the broader 2024 analysis; the two reports utilize different scopes and modeling assumptions, and their totals cannot be combined [28, 29].
They represent modeled scenarios, not empirical forecasts. The figures illustrate what would happen under a hypothetical state where health disparities are fully resolved by 2040. They do not forecast the economic return of any specific legislative or regulatory reform, nor are they derived from peer-reviewed causal evaluations [28, 29].
They measure output rather than total human value. The models translate health improvements into market productivity measured by gross domestic product. By definition, GDP accounts for formal economic output and excludes unpaid caregiving, household labor, and the intrinsic value of physical well-being [28]. The 2024 report itself underscores that the imperative to eliminate health disparities is an ethical and clinical necessity independent of projected macroeconomic returns [28].

7. The Countries Trying to Close the Gap: An International Comparison

Countries have implemented distinct policy instruments to address the medical gender gap. Available evidence varies considerably: some jurisdictions possess detailed statutory mandates, others document administrative implementation, while very few have measured clinical outcomes. To maintain analytical rigor, each country is evaluated using a uniform four-part framework: policy commitment, verified implementation, measured outcome, and remaining gap. The designation “not identified in the sources reviewed” indicates that no verifiable source met the review criteria, not that no activity exists.

United States

Policy commitment. Statutory inclusion under the 1993 NIH Revitalization Act [9], the 2016 SABV policy [10], and the July 2025 revised inclusion guidelines (NOT-OD-25-131) [13]. In March 2024, Executive Order 14120 directed federal agencies to coordinate women’s health research and supported the Advanced Research Projects Agency for Health (ARPA-H) Sprint for Women’s Health [30]. The degree to which that executive order remains active under subsequent administrations was not evaluated here.
Verified implementation. Women comprise approximately 57 percent of enrollees across aggregate NIH-supported clinical research protocols (GAO fiscal year 2014 data) [6]. However, the GAO noted that NIH did not systematically record whether studies planned sex-stratified outcome analyses [6]. The NASEM evaluation documented that NIH grant funding for women’s health research fell from 9.7 to 7.9 percent between fiscal years 2013 and 2023 [25].
Measured outcome. Maternal mortality, an outcome shaped by clinical access, insurance coverage, and social determinants rather than research inclusion policy alone, was 18.6 deaths per 100,000 live births in 2023 (down from 22.3 in 2022); the rate among non-Hispanic Black women was 50.3, compared to 14.5 for non-Hispanic white women [31]. An international comparison by the Commonwealth Fund (June 2024) confirmed that the United States maintains the highest maternal mortality rate among high-income peer nations [32]. These figures do not measure the efficacy of research-inclusion policies.
Remaining gap. Documented evidence linking federal inclusion mandates to verifiable changes in routine clinical diagnosis, prescribing, or long-term patient outcomes was not identified in the sources reviewed.

England

Policy commitment. The Department of Health and Social Care published the renewed Women’s Health Strategy for England on 15 April 2026, a 10-year framework aligned with the NHS 10 Year Health Plan [33, 34]. Key commitments announced in the strategy include expanding menstrual-health education in schools, establishing community musculoskeletal hubs [34], introducing clinical standards for effective pain relief during invasive outpatient gynecological procedures [35, 36], and increasing female representation in clinical trials [35].
Verified implementation. None identified in the sources reviewed. The strategy was published six months prior to this review, and no independent administrative audit or delivery report was identified in the available official literature.
Measured outcome. None identified in the sources reviewed.
Remaining gap. The strategy itself acknowledges severe elective gynecological backlogs and stark regional inequalities [35]. In response to the renewal, the Royal College of Obstetricians and Gynaecologists emphasized that the strategy requires sustained capital funding, clear implementation milestones, and mandatory progress reporting to translate policy goals into frontline clinical improvements [36]. A policy publication documents institutional intent, not verified service delivery.

Canada

Policy commitment. The Canadian Institutes of Health Research (CIHR) mandates that grant applicants integrate sex and gender considerations into research designs where appropriate, and requires peer reviewers in its Project Grant Program to score integration quality [37].
Verified implementation. A 10-year longitudinal evaluation by Haverfield and Tannenbaum in Health Research Policy and Systems (2021) analyzing 39,390 investigator-initiated applications found that applicant-reported integration of sex increased from 22 percent in 2011 to 83 percent in 2019, while gender integration rose from 12 to 33 percent [38]. Since 2018, applications scoring highly on sex integration (odds ratio 1.92, 95 percent confidence interval 1.50 to 2.50) and gender integration (odds ratio 2.53, 95 percent confidence interval 1.83 to 3.50) were significantly more likely to receive funding [38]. CIHR separately reported that 62.4 percent of funded research addressed sex or gender in fiscal year 2018–2019 [39].
Measured outcome. None identified in the sources reviewed. The available metrics track grant applications and funding decisions rather than published trial analyses, clinical guidelines, or patient outcomes.
Remaining gap. Applicant self-reporting does not establish the methodological rigor of the resulting research, and evidence demonstrating translation into clinical practice guidelines or patient health outcomes was not identified in the sources reviewed.

Australia

Policy commitment. The National Women’s Health Strategy 2020–2030 established priorities across maternal health, chronic pain, and reproductive well-being [40].
Verified implementation. A September 2025 baseline assessment reviewed implementation of the National Women’s Health Strategy from 2020 to May 2024, documenting investments in endometriosis research, Birthing on Country models, and national guidance on sex and gender in health research [40]. By 27 April 2026, the Australian Government confirmed that all 33 Endometriosis and Pelvic Pain Clinics were operational across the national network [41, 42].
Measured outcome. The 2025 assessment established an implementation baseline; empirical measures of diagnostic delay or patient clinical outcomes were not identified in the reviewed sources [40].
Remaining gap. The establishment of physical clinics represents an infrastructural milestone; empirical evidence evaluating whether this clinic network has reduced diagnostic delay or improved long-term patient outcomes was not identified in the reviewed sources [40, 41, 42]. The baseline evaluation identified ongoing challenges, including severe sexual and reproductive healthcare workforce shortages in rural regions, substandard access to menopause management, underinvestment in chronic non-cancer pain, and fragmented domestic violence recovery services [40].

Norway

Policy commitment. The Norwegian Women’s Health Commission (Kvinnehelseutvalget), appointed in March 2021, presented its official inquiry, NOU 2023: 5, Den store forskjellen (“The Great Difference”), to the Ministry of Health and Care Services on 2 March 2023 [43, 44]. The report documented that sex differences are not systematically integrated into national health policy, that health conditions predominantly affecting women carry lower medical prestige and status, that cross-service care coordination is fragmented, and that existing evidence on sex-specific biology fails to reach routine clinical practice [43, 44]. The commission recommended elevating the status of female-predominant conditions, increasing public funding for women’s health research, integrating sex considerations across medical curricula and research grants, and establishing a national oversight committee on women’s health [43, 44].
Verified implementation. None identified in the sources reviewed.
Measured outcome. None identified in the sources reviewed.
Remaining gap. Implementation of the commission’s recommendations has not been verified in the sources reviewed. An official inquiry documents institutional deficits; it does not constitute proof of structural remediation.

Cross-national synthesis

Evaluating these national experiences against verified evidence highlights a consistent systemic pattern across jurisdictions:

Grant mandates and statutory inclusion rules (United States, Canada) are associated with measurable enrollment and grant-application indicators. However, the reviewed evidence does not establish how much of these changes was caused by the policies, or whether they have translated into routine clinical practice.
National strategic plans and dedicated clinics (England, Australia) generate political momentum and establish physical infrastructure, yet their frontline reach is constrained by clinical workforce shortages and the absence of routine outcome tracking.
Independent commission inquiries (Norway) provide comprehensive structural diagnoses and actionable reform roadmaps, yet they face the recurring challenge of translating advisory consensus into enacted legislative and financial mandates.

Across the five jurisdictions reviewed, the available evidence shows a recurring gap between administrative milestones such as trial rosters, policy documents, and clinic openings and demonstrated clinical endpoints, such as shorter diagnostic delays, fewer adverse drug events, or improved survival. This is a gap in the outcome evidence identified by this review, not proof that the policies or services have produced no clinical benefit.

A 2026 multilevel analysis in Health Policy evaluating healthcare access across 29 countries (2,781 survey respondents) found that women reported poorer healthcare access than men in 24 of the 29 nations, with disparities observed to be wider in countries characterized by smaller gender pay gaps [45]. Because the study is cross-sectional and measures self-reported access rather than diagnostic accuracy or treatment quality, it identifies statistical associations rather than causal mechanisms [45]. It does not indicate that societal gender equality worsens healthcare access. It does, however, demonstrate that broad societal indicators of gender equity cannot serve as proxies for clinical quality in healthcare delivery.

8. From Inclusion to Accountability: Closing the Divide

Achieving progress in closing the medical gender gap requires moving beyond enrollment tracking to enforceable accountability across three verifiable endpoints:

Rigorous research design and analysis: preclinical assays and clinical trials that are designed, stratified, and reported by sex where biological or clinical plausibility warrants [2].
Accurate, calibrated clinical standards: clinical practice guidelines, diagnostic biomarker thresholds, and dosing standards that reflect sex-specific physiology [16, 19, 22].
Verifiable patient outcome improvements: documented reductions in diagnostic delay, decreases in preventable adverse drug reactions, and narrower disparities in chronic morbidity [3, 21, 28].

The four measures detailed below represent actionable policy proposals. None currently exists as a universal statutory requirement. Each identifies a proposed responsible body, scope, baseline, metric, reporting schedule, and operational definitions to enable rigorous oversight.

Proposal 1: Require Sex-Analysis Plans and Results Reporting for Pivotal Trials

Responsible body and scope: Drug regulators, including the US FDA and European Medicines Agency, for pivotal Phase III trials in therapeutic areas where established evidence or biological plausibility supports clinically meaningful sex-associated differences in disease mechanisms, treatment response, or safety.
Metric, baseline, and success criterion: Metric: annual proportion of eligible pivotal Phase III trial protocols associated with marketing applications that have prespecified sex-stratified analysis plans at initial regulatory filing and publicly report sex-disaggregated outcomes within 12 months of primary completion, subject to applicable statutory exceptions. Define the reporting cohort by the date of marketing-application submission. Assess each eligible protocol against both requirements, and report protocols whose 12-month reporting deadline has not yet elapsed separately as pending rather than classifying them as noncompliant. Count each unique protocol identifier once per audit cycle, including when a protocol supports multiple indications or dossiers. Exclude developmental assets until formal marketing-application submission. Baseline: retrospective audit of marketing applications submitted over the preceding three fiscal years, with protocol-level deadline status reported separately. Success: achieving at least 90 percent compliance among protocols for which both requirements can be assessed within three years of policy implementation, accompanied by transparent reporting of subgroup confidence intervals and effect estimates.
Schedule and reporting owner: Annual public evaluation published by the regulatory agency’s clinical trial registry office and medical review divisions.
Implementation route and operational definitions: Builds upon existing clinical trial registries and policy frameworks. Operational definition: Requires a prespecified scientific rationale for sex-stratified analysis, a justified sample-size or precision calculation, and transparent reporting of treatment-by-sex interaction estimates and confidence intervals. Conventional statistical power (e.g., 80% power to detect an interaction at alpha=0.05) is treated as one possible design target where clinically warranted, not a universal regulatory mandate; where powering for subgroup interaction is not feasible, sponsors must report limitations transparently rather than pooling data without qualification. In the United States, results submission within one year of primary completion applies to applicable clinical trials under 42 CFR Part 11, subject to statutory delay exceptions; for other regulatory jurisdictions, submission schedules and registries would follow local statutory frameworks (such as the European Union Clinical Trials Information System under Regulation EU No 536/2014) or proposed regulatory policy.

Proposal 2: Post-Marketing Pharmacovigilance Audits for Sex-Stratified Safety Signals

Responsible body and scope: National drug safety authorities (such as FDA CDER, EMA PRAC) across all authorized prescription medications with active post-marketing safety registries.
Metric, baseline, and success criterion: Metric: annual number of products audited for sex-disaggregated adverse event signals; number of resultant safety communications or label updates. Baseline: current product labels and post-marketing surveillance databases. Success: documented periodic safety reviews resulting in calibrated dosing or label warnings where evidence warrants.
Schedule and reporting owner: Biennial pharmacovigilance reports issued by designated national drug safety surveillance centers [21].
Implementation route and operational definitions: Requires standardized reporting algorithms to account for reporting volume biases inherent in spontaneous adverse-event reporting systems. Operational definition: Disproportionality thresholds (such as an illustrative candidate relative reporting ratio of 1.5 or greater, or proportional reporting ratio PRR of 2.0 or greater with lower 95% confidence limit above 1.0) are designated as preliminary screening triggers to prioritize safety signals for formal clinical and pharmacokinetic review, rather than established causal metrics or validated universal standards.

Proposal 3: Medical Education and Accreditation Curriculum Audits

Responsible body and scope: Medical school accreditation bodies (such as the Liaison Committee on Medical Education [LCME] in the United States, the Committee on Accreditation of Canadian Medical Schools [CACMS] in Canada, and the General Medical Council [GMC] in the United Kingdom) across undergraduate and graduate medical curricula.
Metric, baseline, and success criterion: Metric: proportion of accredited medical schools with documented curricular modules and examination items on sex-differentiated pharmacology, non-obstructive coronary pathophysiology, and chronic pelvic pain diagnostic pathways [16, 21, 22]. Baseline: national curricular survey. Success: 100% compliance across accredited institutions.
Schedule and reporting owner: Evaluated at each institutional accreditation review cycle; published in accreditation council annual summaries.
Implementation route and operational definitions: Operates through educational accreditation standards rather than pharmaceutical regulation. Feasibility depends on jurisdictional governance of medical education and licensing examination boards.

Proposal 4: Burden-Benchmarked Research Funding Evaluations

Responsible body and scope: Public biomedical research granting councils (NIH, CIHR, UKRI/MRC) across their full extramural grant portfolios.
Metric, baseline, and success criterion: Metric: grant allocation share dedicated to women’s health conditions, evaluated against the five-part governance framework in Section 6. Baseline: the NASEM finding of 7.9% of NIH grant funding in fiscal year 2023 [25]. Success: transparent, multi-variable portfolio audits published annually rather than arbitrary rigid quotas.
Schedule and reporting owner: Annual portfolio tracking published by research funding agency executive leadership and reported to national legislative committees, as recommended by NASEM [26].
Implementation route and operational definitions: Requires an internationally harmonized definition of women’s health research to resolve current methodological disputes between funding agencies and advisory committees regarding portfolio classification [27].

Tracking policy declarations or enrollment percentages alone represents a superficial assessment of equity. Robust oversight requires monitoring translational behaviors and patient outcomes: audit compliance rates, the frequency of sex-stratified regulatory label reviews, and measured reductions in diagnostic delay for conditions like endometriosis, where baseline delays of 6.8 years are documented but definitions vary across health systems [3, 4].

Basic research design, clinical translation, and health governance form an interconnected chain. Preclinical assays that exclude female biology can leave important questions unanswered; clinical trials that pool data without appropriate sex-specific analyses can obscure differences in treatment response; and regulatory policies that track enrollment without adequate analysis and reporting leave critical translational links unexamined.

The ultimate measure of medical progress is not whether policies announce parity, but whether evidence-based research delivers accurate diagnoses, safer prescribing, and measurable improvements in health outcomes for every patient.

References and Source Index

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