Facts vs. Fear: NIH Cuts and The Future of Women's Health Research
Cutting through the noise with Kathryn Schubert, President & CEO, Society for Women’s Health Research
The first 60 days of the Trump administration have been marked by sweeping policy changes — many with profound implications for women’s health. From executive orders on fertility care to deep cuts to NIH funding and staffing, the world of research and medicine is in the midst of seismic disruption. In recent conversations with builders across digital health and life sciences, a heavy cloud of fear, frustration and fatigue hangs over. I, for one, find myself oscillating between news alert-induced anxiety spirals and the temptation to disengage entirely. Despite the appeal of tuning out, now is the time to tune in; my aim is to help separate fact from fiction and equip those building in the space with the knowledge they need to navigate this moment… not just the challenges, but dare I say, the opportunities.
To help make sense of the shake up, I sat down with Kathryn Schubert, President and CEO of the Society for Women’s Health Research (SWHR) — a policy powerhouse dedicated to closing the gender gap in research. SWHR has been on the front lines of policy and advocacy on Capitol Hill for decades. They were instrumental in standing up women’s health offices across the federal government in the 1990s and crafting the 2016 policy on Sex as a Biological Variable (SABV), which requires NIH-funded researchers to consider sex as a fundamental variable in study design, analysis and reporting (PSA: this is still in place!). Of note, SWHR is uniquely non-partisan — positioning Kathryn and her team to work across the aisle and find areas for alignment and opportunity — even amidst unprecedented threats and polarization.
In our conversation, we break down what we know, what’s still uncertain, and how the private sector can step up to advance women’s health research and outcomes amidst mounting political and funding threats.
A Brief History of Sex-Based Research
Carolyn Witte (CW): Let’s start with some context. Can you give us a brief history of sex-based research in the U.S. — from the 1993 NIH Revitalization Act to the SABV mandate in 2016 and beyond? What progress has been made, and what are the biggest gaps that remain?
Kathryn Schubert (KS): It’s hard to believe that when Congress passed the NIH Revitalization Act in 1993, women had been actively excluded from participating in clinical trials. In brass tacks terms, this means that all of our research up until that point, whether it was determining a response to a drug or treatment or gaining an understanding of a disease or condition, was based on studies with only men. Recognizing that men and women are fundamentally different and that needed to be accounted for in research, this legislation required the inclusion of women and underrepresented minorities in research at the NIH; other federal agencies, such as the U.S. Food and Drug Administration, followed suit. Excitingly, women now make up about 50% of participants in U.S. clinical trials between 2000-2020 — a testament to the power of policy to drive sweeping change and make our research and health care system more equitable.
But, including women in research is only the first step. That’s why the SABV policy was so important. It set an expectation that women not merely be included in research, but that researchers consider biological sex in research analysis and reporting. From the implementation of the NIH Revitalization Act to the implementation of the SABV policy was more than 20 years — 20 years where research gaps were further exacerbated.
Most importantly, the policy is in place now and there is no doubt that men and women have fundamental biological differences. The question we have now is to what extent the SABV policy is being adhered to and enforced. Are grant reviewers following this policy in practice? Are there any ramifications for researchers not following the SABV policy? We believe there needs to be an accountability mechanism, and even further, a way to ensure the analysis of sex-based differences data where appropriate, rather than simply consideration or acknowledgment of those differences in research.
CW: It's amazing to see the progress made in terms of women's participation in clinical trials. But as you point out, including women is not sufficient. I want to double click on the analysis issue that you mentioned. According to the recent McKinsey report, only 25% of clinical trials in the U.S. have sex-disaggregated data. Said another way, we may be including women in research, but we’re still not doing the work to distinguish sex-based differences between men and women. Can you explain in layman's terms what disaggregating data based on sex means and why this is so important?
KS: When we call for data to be disaggregated by sex, we simply mean that the results should be broken down in a way that lets us view how males and females respond separately.
For example, every clinical trial collects demographic data — sex, age, race etc — which you’ll often see at the start of a study. But, when it comes to the results, the findings are rarely analyzed or reported by these groups. That means we might know that women were included in a trial, but we don’t always know whether they responded differently to a drug or treatment.
Disaggregating data by sex helps uncover trends, disparities, and variations in treatment responses that would otherwise go unnoticed. In our view, this is key for personalized care — for providers to counsel patients (men and women alike) on sex-specific considerations (risks, benefits, side effects etc).
Making Sense of the Shake Up
CW: Switching gears to today… the last eight weeks have been dizzying from a health care policy perspective — from federal leadership appointments to a pause on NIH facilities and administrative costs to the take down of critical public health websites (just to name a few!). There’s been a flurry of executive orders as well — many of which, like the E.O. on IVF access, “plant a flag” so to speak but are light on details.
Can you help make sense of this all? What are you paying close attention to? Which changes poise to have the largest impact on women’s health research?
KS: Research is at our organization’s core, so any federal changes that have implications for the U.S. research enterprise are what we’re paying the closest attention to, although there are also important conversations around coverage and access that are impactful to women, which we’re also following closely.
Of greatest concern to us right now are the large-scale reductions to our health workforce — from agencies including NIH, CDC, FDA, and more. These cuts are worrisome for many reasons, but to name a few we fear they could cause research delays, stifle innovation, reduce the ability of these agencies to attract the nation’s top scientific talent, and put America’s standing as a global scientific leader in jeopardy. These agencies directly affect our ability to keep Americans safe and healthy, and we fear these cuts are short-sighted.
Beyond that, we have seen several key datasets and information being removed from federal websites; these datasets are wide ranging from HIV/AIDS data to breastfeeding and adolescent health data, but all play a critical role in public health and research. While we’re hoping some will be put back online after the administration conducts its review of policies and programs for compliance with the President’s executive orders, we are concerned that the longer these resources are unavailable, the further behind research gets. These datasets are critical for scientists to conduct their research and for health care providers and families who are trying to make the most informed decisions about their care. We urge the administration to restore these resources immediately.
We’re also keeping a close eye on the federal funding freezes and what happens there. I think there’s still a lot that’s unclear right now, but regardless, we’re already seeing the ripple effects of this on our research enterprise. We have seen reports of universities enacting hiring freezes and cutting PhD admissions, which is devastating from a research perspective.
Beyond that, moves to hinder the public participation in the rule-making process may have far-reaching implications, and we continue to urge the administration to ensure transparency and clarity as well as allow for public participation in regulatory matters.
CW: It seems to me that the Trump administration has been conflating DEI efforts with the study of sex-based differences; I fear this could be a catastrophic “throw the baby out with the bathwater” moment. What are the risks of this conflation? How can we prevent the war on DEI and “wokeness” from rolling back the gains we’ve made on sex-based research?
KS: Educate, educate, educate. We have to let policymakers know why sex differences research is important and keep reinforcing that message. Sex differences research studies how biological sex influences health, disease, and behavior. That knowledge is essential for providing the most effective, efficient health care possible — improving outcomes for both women and men. That’s the message.
CW: There’s a big difference between taking down a marketing page and shifting what happens in a lab. What are the practical implications of these policy shifts for life sciences organizations and researchers studying sex-based differences today?
KS: The key issue is that it’s not just “marketing” or “informational” pages disappearing — it’s entire CDC and HHS datasets, training materials, and research tools that scientists rely on. When those resources become inaccessible, it directly hinders researchers' ability to do their jobs.
Studying sex differences is essential for developing more effective, precise medications, ensuring the safety of medical products and devices, and deepening our understanding of diseases. Without access to this data, we risk setbacks in medical innovation and health care outcomes. At the end of the day, these resources aren’t just nice to have — they’re fundamental to producing high-quality science and ensuring that taxpayer dollars invested in research generate the greatest possible impact.
Funding Challenges & the Role of the Private Sector
CW: Just last year, former President Biden signed an Executive Order launching the Women’s Health Research Initiative, including a $200M NIH investment in women’s health through ARPA-H. Do we know the current status of this initiative?
KS: Based on our findings, as of right now that executive order is still active, and it is our hope that it remains so. Women’s health research is a non-partisan issue and — what’s more — the knowledge we gain from these studies informs our overall understanding of disease. It’s in the best interest of everyone in our society, for this generation and future generations, to fund this research.
CW: Deregulation and cutting waste is a big theme of the current administration. Where do you see regulation as a force for good in terms of advancing women’s health research and outcomes, and where is it a barrier?
KS: Overall, I think regulation puts important guardrails on elements of our public health and health research systems. For example, regulation serves a critical role in FDA’s work — we want drugs, medical products, and devices to go through the agency’s rigorous evaluation process. That’s essential from a public health safety perspective. Additionally, regulation can be helpful for things like ensuring accountability to policies like the SABV policy to ensure we’re considering sex differences in research. But it’s always important to continually evaluate the use of federal dollars and research infrastructure to reduce red tape, eliminate barriers, and make research more effective and efficient. For instance, there’s a lot of talk in the scientific community about the administrative burden placed on federally-funded scientists and discussion that they are currently forced to spend too much time on compliance. There are likely some changes we could make there that would serve both the research institutions as well as our federally funded researchers.
CW: On the subject of waste, the Trump administration has proposed capping indirect costs in research at 15%. Could this push for efficiency have unintended consequences, or could it actually drive positive outcomes?
KS: For those unfamiliar, indirect costs, often called overhead, are the expenses that research institutions incur beyond the direct costs of conducting a study. This includes maintaining lab facilities, supporting administrative staff, ensuring compliance with federal regulations, and even keeping the lights on in research buildings. These costs are negotiated between universities and the federal government and typically are well above 15% — often around 50% or more for major research institutions.
The debate over indirect costs isn’t new, but what is new is the Trump administration’s move to cap them at 15% with no warning — leaving universities and research institutions no time to adjust their plans. In fact, Congress itself put it into the appropriations law that the administration does not have the authority to change current indirect costs as already negotiated. If efficiency is the goal, we believe there are smarter ways to ensure taxpayer dollars are well spent without abruptly cutting the very infrastructure that allows research to happen in the first place.
One of the main pieces we’re concerned about at SWHR is the implication for institutions with fewer resources — especially those that serve underrepresented communities. While these caps on indirect costs are likely to affect all institutions’ ability to conduct research, the smaller players that lack big endowments or private donors will likely have a more difficult time shouldering the costs for maintaining facilities and supporting administrative functions than the big Academic Medical Centers. This could mean they are disincentivized from pursuing research, which means we may lose the diversity of perspectives — key for allowing our research enterprise to flourish.
Advocacy, Action & Opportunity
CW: What are the main policy fights happening now to protect and expand funding for women’s health research?
KS: The biggest fight right now is protecting funding generally. We have seen in recent budget conversations that Republican lawmakers are eager to make cuts to non-defense discretionary spending, which includes health care. In a “cut” environment, all programs and agencies are on the chopping block for reductions or eliminations in funding. While we’ll continue to advocate for the importance of providing funding increases to our nation’s federal research agencies to account for inflation and provide meaningful growth, our biggest fight is likely to be preserving what we have right now.
CW: What do you see as the biggest opportunities for progress within the current political climate?
KS: In the last Congress, we saw a lot of momentum in certain areas of women’s health — namely on healthy aging and midlife health issues like menopause. I think there’s ample opportunity to continue that this year. Menopause, bone health, obesity, Alzheimer’s disease, and cardiovascular disease are not partisan. Moreover, they are all key drivers in U.S. health care costs each year and will only become more important given the growing aging population in the United States. I’d like to see progress implementing policies that can meaningfully improve health and quality of life outcomes for women in each of these sectors.
CW: How can individual advocates — whether they’re researchers, health care providers, or everyday women — help push for better policies?
KS: Pushing for better policies can be as simple as sharing what you’re seeing and experiencing in your everyday life. Organizations like ours often look at research and monitor for overall trends —and we’ll share those with policymakers — but statistics can fall flat unless you can put a human experience to it. Sharing your story is invaluable. Let policymakers know what is happening in the clinic, what is happening in the lab, how your day-to-day is impacted by your disease, condition, or role as a caregiver. If you’re experiencing it, others are as well, and it’s important for policymakers to know how women across the country are potentially being impacted by the current state of affairs.
CW: How can the private sector best step in if research funding diminishes or if there are rollbacks in policies that serve to advance women’s health in research?
KS: Policy debates aside, there is a business case for investing in women’s health and women’s health research — it’s ripe with opportunities that can drive meaningful ROI and boost our economy. I would encourage the private sector to closely monitor what happens over the next several months at our nation’s research agencies and see which programs and research initiatives are scaled back or eliminated entirely and then to step in and fill those voids. I believe we can cure endometriosis in our lifetime. I believe we can better understand what causes uterine fibroids. I’d love to see more private sector entities helping us get at the root causes of the diseases, conditions, and life stages that differently, disproportionately, or solely affect women.
We’ve only scratched the surface here — stay informed & join the conversation!
The policies shaping women’s health research and funding are evolving rapidly, and we’ve only begun to unpack their implications. For those looking to stay ahead of key developments, here are a few must-read resources:
📩 Sign up for the SWHR Newsletter: get regular updates on the latest policy changes impacting women’s health from Kathryn and her team
📖 Dive into the Menopause Discussion on Capitol Hill: check out this SWHR deep dive into the recent legislative conversations around menopause research, funding, and access to care; I am personally optimistic that this is one area we can make positive progress on within the current climate
🔎 Bookmark Manatt Health’s Federal Policy Tracker: this is my go-to, bookmarked resource for keeping tabs on real-time federal health policy changes. With easy filtering by date, agency, and topic, it’s an invaluable tool for staying informed on administrative, regulatory, and litigation activity
Women’s health research depends on engaged voices and informed action — let’s keep the conversation going. Where are you seeing the real-time impact of these policy threats and shifts in your work? What gray areas still need clarifying? Drop your thoughts in the comments.
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