Q&A: Wayne Batchelor Reflects on the State of Medical Research Early in the Second Trump Term

When Donald Trump regained the US presidency, he quickly began rolling out executive orders on a wide range of issues, including directives aimed at diversity, equity, and inclusion (DEI) initiatives and funding across government agencies. TCTMD spoke with Wayne Batchelor, MD, MHS, MBA (Inova Health System, Fairfax, VA), about the early impact within the cardiovascular research community.

What has been the reaction to these early actions among researchers, and what consequences have they had so far?

The first-and-foremost response to all of this is a sense of surprise and confusion. Most clinical research that we do requires collaboration among multiple stakeholders. Academicians often work with industry partners, with government funding agencies like the National Institutes of Health (NIH) and the National Science Foundation (NSF), and with the Food and Drug Administration. This collaborative ecosystem has recently been severely disrupted. There was an initial freezing of federal grant funding, and we will have to see what happens after a temporary stay has been issued. Some research was halted directly because of the executive order, while other projects have been impacted indirectly by the state of uncertainty and confusion.

How has the order eliminating DEI programs in the federal government affected research?

There have been both direct and indirect effects. The direct effects relate to the initial freeze in funding, but there have also been indirect effects resulting from uncertainty and confusion. Several government bodies—including the NIH, FDA, Centers for Disease Control and Prevention (CDC), and NSF—are confused in terms of what constitutes DEI. For example, is research on patients with sickle cell anemia funded by an NIH grant supporting a minority investigator considered DEI research? What about innovative implementation science aimed at strategies to ensure better inclusion of women, minorities, and older adults in clinical trials—is that DEI? Right now, some of these types of projects have been put on hold until we know more. I hope that this is a temporary response. But it’s really slowing down progress tremendously.

There is currently a statutory requirement for industry sponsors to put forth a diversity action plan that defines goals for study subject enrollment disaggregated by age, sex, race and ethnicity, and specifies the strategy for achieving these goals. The purpose is to ensure that the safety and efficacy data supporting new device and drug approvals better matches the intended use population—to me, this is not a DEI initiative, it’s simply good science. To help achieve this goal, there have been efforts to predict enrollment of women, minorities, and older adults in clinical trials from research site characteristics. This work has been halted. My hope is that once the dust settles, these and other efforts will restart since this is central to the basic goals of clinical research.

What effects do you expect to see when you look further out?

There has been a ripple effect that is going to test several aspects of our research ecosystem, and we don’t know yet how this is going to affect patients. However, I have concern that severely hampering research runs the risk of negatively impacting public health.

Many research programs that have been supported by federal funding are in a state of uncertainty. Clinical research ecosystems tend to be complex, highly integrated systems that are reliant on continued collaboration between multiple stakeholders, including government entities. If you pull one or two pillars from the model, the whole thing shuts down. It’s going to take focus and persistence to figure out how to navigate through these changes. It is my hope that the volume of clinical research and its quality and integrity will not be compromised. Historically, the scientific community has kept as their North Star the pursuit of sound science. We cannot waver from that.

I am also concerned that this will change the way we engage in research. The United States is the most important country in the world for producing meaningful data that help advance health, not only in our country but across the world. If now, we hamper US research, I’m worried about long-standing broader effects.

How effective will these efforts be at reining in costs?

As the president of a service line at a decent-sized health system, I understand the importance of financial stewardship. However, I do fear that these recent changes will not be effective in controlling costs without having unnecessary and unintended consequences on public health. Major advances in medicine do not result from the single acts of healthcare providers and hospitals. This effort requires continued investment in research and collaboration from scientists, clinicians, industry partners, funding and regulatory bodies, and representative study subject participation. I don’t think the average person understands just how complicated the clinical research ecosystem is. If government programs and funding are compromised or restricted, whether under the guise of DEI or any other way, we lose a key pillar and research will suffer. This may save some federal dollars temporarily, but will come at a significant cost to public health.

What other issues do you see arising from these executive orders?

I recently attended the Heart Valve Collaboratory meeting in Washington, DC, that brings together key stakeholders to create a collaborative multistakeholder community to advance the field of valvular heart disease. The NIH and FDA were noticeably absent. Although the team put on an outstanding meeting, it was odd not having these key stakeholders present and their input was sorely missed. As one of the keynote speakers at the meeting noted, we are in an era of misinformation where many are questioning scientific truths. It is easier to disseminate false claims than it is to defend accurate facts. Standing up for the research that helps us establish scientific truths will require vigilance, persistence, and well-done, adequately funded, multistakeholder, collaborative research using an infrastructure that has taken decades to build. We must all stand up for good science—the future health of our nation hangs in the balance.