Terry Gerton Dr. Polan, I want to start with you. The American Public Health Association filed a lawsuit against the National Institutes of Health for targeting research on disfavored topics of populations. Tell us about what you heard from your constituency that incited the case.
Dr. Susan Polan We have members who are researchers in academic institutions and a variety of other places. And they focus on trying to make populations healthier. You can’t do that without understanding all populations. And so what we were hearing is that their ability to do their research was stopped because their funding was rescinded, or their opportunity to do research was stopped because the proposals were not being considered on things like vaccines or DEI or LGBTQ+ issues. All of these things are critical because you cannot predict at the beginning of research what you’re going to find out at the end. And so by taking away these, what are called disfavored populations, you’re basically impacting the entire population.
Terry Gerton And were researchers in mid-project when the funds were pulled, or were they new projects, pending projects?
Dr. Susan Polan They were all, they were throughout the process. So some were, had already received their funding and they were, so they were mid-project, some were in the process of being reviewed and were fairly far along and were expecting to receive support for their work and they were cut off. And then there were some earlier in the process, along with training people, and that was another important piece of this work.
Terry Gerton Ms. Agarwal, tell us about the case. How did the litigation shape up, and what’s the status of the case so far?
Shalini Agarwal Sure. So we brought the lawsuit on behalf of APHA, which is a wonderful public health organization, along with the UAW, a union, IBIS, which a reproductive research organization in Massachusetts, and a number of private researchers. So the folks whose actual work was being funded by these NIH grants. And on behalf all of these plaintiffs, we filed lawsuit against HHS and NIH in federal court, primarily alleging that the change in agency priorities that the agency was trying to effectuate by slashing research to these disfavored topics was what’s called arbitrary and capricious. So it violated the Administrative Procedure Act. And basically what that means is that they didn’t make a reasonable decision and they didn’t explain themselves reasonably at the time. So, for example, with the DEI grant terminations, sometimes if a grant had the word diverse in the proposal somewhere, that was enough to terminate. If a grant had included as one subject, like one set of population that it was dealing with, transgender individuals, that was enough to terminate. If a grant helped to support training for a researcher from a group that had been traditionally not well represented in the research field, for example, someone whose family had been on food stamps or had not graduated college, that was enough of a reason to terminate. So that sort of broad-based and almost haphazard, frankly, cutting of research was arbitrary. That was essentially the claim. We also brought constitutional claims, but ultimately the court ruled on the Administrative Procedure Act claim.
Terry Gerton And what was the ruling?
Shalini Agarwal The court agreed with us that yes, this is arbitrary and capricious to just cut these grants. It’s especially galling where you see NIH has statutory mandates. So Congress has set out that NIH should be specifically addressing disparate impacts between different populations, addressing minority health and promoting, making sure to promote greater diversity within the research field. So those were sort of, not sort of, those were explicit mandates from Congress that the NIH was just flouting completely. And so the court concluded in a really strong opinion that the directives that the agency had issued were unlawful, arbitrary and capricious, so he set them aside. In addition, he said any grant terminations that were conducted pursuant to those directives, those would also be set aside so that they were, had to be, the result of that was that the grant money had to then be restored to the researchers.
Terry Gerton And have the grants been restored?
Shalini Agarwal So our understanding is that for most of our plaintiffs and most of the APHA members, or for the APHA members we represent and for the other plaintiffs, that the grants were restored. After that there was a Supreme Court intervention, so that has affected the prospects going forward, but at least as we understand it, the grants were largely restored.
Terry Gerton I’m speaking with Dr. Susan Polan, she’s the associate executive director for public affairs and advocacy with the American Public Health Association, and Shalini Goel Agarwal, who co-leads Protect Democracy’s free expression and the right to dissent team. So Dr. Polan, let me come back to you. What are the broader public health consequences if we terminate research on things like vaccine hesitancy or LGBTQ health or racial disparities? What are you hearing from communities out there?
Dr. Susan Polan So as I said earlier, when you start research, even if you’re focusing on a specific population, the implications of that research are often much broader. And so what we’re hearing is that people are not going to be able to understand and will lose the capacity to, or lose years in our understanding of everything from cancer prevention to heart disease and stroke, to things about, to where and what issues we might have with vaccines and what are safety and efficacy issues related to vaccines. So all of the ways that we’re trying to improve the public’s health are going to be undermined by this. Even though the, ostensibly it is for specific populations, the implication is much broader.
Terry Gerton And are your researchers able to restart their programs now that the grant funding is flowing again?
Dr. Susan Polan That’s another issue for those, there are a number of our researchers and members who were able to be part of the lawsuit, but not all. So for those who were able to be part of our lawsuit, for the most part, it was a break, but it wasn’t a break that was so dramatic that they’re not going to be able to restart. But for those people who are not able to part of lawsuit for a whole array of reasons, they are lost. Their ability to do their work is going to be very difficult. And yes, they may be able to get other funding to restart it, but they’re going to lose months and maybe even years before that happens, which means that we are going to lose months and even years of understanding the implications for everybody. And that is hugely problematic.
Terry Gerton There have been political swings in the science space before. Does this one feel different to you? Are we seeing a shift in how politically sensitive medical topics are being handled now?
Dr. Susan Polan It absolutely does. I mean, what we’ve seen before are restrictions on research at the Centers for Disease Control and Prevention related to guns. And that was a content issue, but this is directed at people. And that’s a very different issue. And so it’s targeting communities and saying that these communities are not worthy of us doing the research. And that is just a horrible way for a government to act, to say, that some parts of our population do not have enough value that we want to understand how to keep them healthy.
Terry Gerton And so Ms. Agarwal, let me come back to you. What is the next step here legally or legislatively?
Shalini Agarwal Sure, yeah. I’ll go back to the Supreme Court decision, because I feel like I did not fully explain that earlier. So after the trial court issued its judgment setting aside this guidance, the directives that the NIH had put out, the agency sought a stay. So that’s basically like, while we’re resolving this case, which will take several months for parties to brief and the courts to hear on appeal, in that time, will you please, court, stop the effect of the trial court’s ruling? And so they sought a stay from the district court itself and the court said no, denied the stay. Same thing happened at the First Circuit. And then they sought a stay at the Supreme Court. And this is a one on what’s called the shadow docket, where there’s really limited briefing and no argument and not much explanation for the decisions made by the court in that sort of abbreviated stay posture. And there, the Supreme Court issued a really fractured ruling. Basically, in a really short page and a half, the court did agree to stay part of the lower court’s ruling. So I guess the take-home point from the Supreme Court was it did not stay the ruling as it applied to the directives. So the policy documents that say, NIH is deprioritizing these subjects and we’re not going to fund them, that part of the court’s ruling, saying that that’s arbitrary and capricious and has to be set aside, the Supreme Court did not touch that part of the ruling and said, we’ll deal with that at a later time, but it did stay the ruling as it applied to the terminations. And it said, terminations, grant terminations where the effect is that you have to restore the funding, that feels to us like a contract. And we think that you can’t get that relief in this federal court, you have to go to the specialized contract court called the Court of Federal Claims. And it was a really fractured decision in that four justices would have let the full ruling stand from below and four justices would have stayed the entire thing. And we had one justice, Amy Coney Barrett, who was a decisive vote and sort of split her decision. So we are currently in the First Circuit Court of Appeals. So this is the level up from the trial court. And we are now doing briefing on the merits. So this not just like whether the decision of the trial court should be stayed, but was the decision of the Trial Court correct? And so we will hopefully prevail there and, either way, I imagine we’ll end up at the Supreme Court again, and then the Supreme Court will actually issue, we hope, an opinion that will have lasting significance other than just unsigned or a short shadow docket ruling.
Terry Gerton That’s really helpful framing. And Dr. Polan, let me come back to you then. Is APHA sensing any interest from Congress in getting engaged to create a framework that prevents this sort of pendulum swinging in the future?
Dr. Susan Polan We are hearing concern, but not hearing that action is going to be a priority in the short term. And I think a lot of this is going to, everybody’s taking a wait and see attitude and watching how this all plays out in the courts, watching how it all plays in reality. But there are so many different ways that public health is under attack that it is really hard to get a path forward on any one of these things. I want to, if I can, just correct something I said earlier about CDC. And what I said was that CDC earlier had restrictions on research, and it actually wasn’t. The restriction was on the ability to do advocacy, and it therefore had a chilling effect on research. So it wasn’t as direct as this is. I also want to add that in addition to the research, it’s the grants and funding for training that have been cut. And that means that whole populations of early career professionals or professional or students who are making their way through graduate school supported by these programs are no longer able to finish their PhDs or finish their research. So we’re losing a whole generation of researchers as well.
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