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“Research Ethics Reimagined” is a podcast created by Public Responsibility in Medicine and Research (PRIM&R), hosted by Ivy R. Tillman, PRIM&R's executive director. Here, we talk with scientists, researchers, bioethicists and some of the leading minds exploring new frontiers of science. This season, we are going examine research ethics in the 21st century -- and learn why it matters to you.
I'm your host, Catherine Batsford.
Dan McLean:And I'm your co host today, Dan McLean
Catherine Batsford:Today, we are pleased to have with us Doctor. Josh Fessel. Doctor. Fessel is a physician scientist with experience across disciplines, across phases of research, across sectors, including academia, federal government, public private partnerships, and across domains, including person centered strategic policy, regulatory operations, and communications. Most recently, Dr. Fessel served
Catherine Batsford:as Chief Medical Officer and Director of the Office of Translational Medicine in the National Center for Advancing Translational Sciences at the NIH. Simply put, Doctor. Fessel describes his big goals as developing more effective ways to turn discoveries into action to treat and prevent diseases of all types. Josh, thanks so much for being with us today on our podcast. We are excited to tell your story to our listeners.
Josh Fessel, MD, PhD:Thank you so much. Me too.
Catherine Batsford:So as a physician, did you always imagine your work would be so closely tied to research and eventually to serving at the NIH?
Josh Fessel, MD, PhD:I love that. The short answer is no. Quite honestly, the federal service trajectory was never on the menu. And honestly, I came to research kind of, I won't say later in the game, but it wasn't the primary goal from day one. I came to things from a family where there aren't any physicians or scientists in my family.
Josh Fessel, MD, PhD:So I didn't really I was kind of blazing a trail there as far as my family goes. Grew up in small towns in rural Illinois and Indiana and went to undergraduate at the University of Evansville, which is a wonderful place, small liberal arts university, best known for its technical theater program. But it was actually great preparation for what I ended up doing, because I got a lot of interaction in one on one and small group settings, which is a lot of what you do in both medicine and science, particularly in the earlier training phases, medical school and graduate school. But I went to undergrad thinking I wanted to go to medical school, and one of the done things was to do some kind of research because that makes your application stronger. I hadn't planned on falling in love with lab based research, but I did.
Josh Fessel, MD, PhD:It was kind of a moment of crisis initially because I thought, Wait, I'm supposed to do medicine. You know, but now I love this research thing. And I found out that there are ways to do both, and so that's what I ended up doing. And then you asked about, did I ever imagine it would lead to the National Institutes of Health? No, I didn't even know what the National Institutes of Health was when I first fell in love with research.
Josh Fessel, MD, PhD:Learned about it later or started to learn about it later, I guess. But honestly, I was well on my way to a fairly traditional looking academic physician scientist career. I hit a point where I realized I wanted more in terms of impact. I wanted to look at the field of research that I was involved in. At the time, it was pulmonary disease, lung disease.
Josh Fessel, MD, PhD:I'm trained as a pulmonologist and intensivist. I wanted a different perspective on the research field. So I was trying to figure out how to do that. And honestly, moving into government work was something of a happy accident. I got an email from somebody at the National Heart, Lung and Blood Institute.
Josh Fessel, MD, PhD:And truly, the main reason I opened it was because I had some collaborators there and I thought, Oh, they probably I'm probably late with revisions on a paper. They probably want some data or something like that. But it actually turned out that it was talking about an opening for a medical officer in the area that I worked in, in pulmonary vascular disease. And I thought, gosh, they were nice enough to send this out and I ought to at least put my application in. And thinking that if I went to the interview, I would probably, at the end of the time, say, know, and this was pre pandemic, so we still did all of our interviews in person, all that kind of thing, figured I would say, thanks, this was really interesting.
Josh Fessel, MD, PhD:Not really what I'm looking for, but now I know the people who are going to be reading my grants and, you know, I'm going be working with these people for a long time. From the standpoint of an investigator, by the end of the interview day, I had fallen in love with the job. And I, you know, I was talking to my wife as I was waiting for the rideshare back to the airport. And I'm telling her about the day, she says, we're moving to Washington, DC, aren't we? And I said, and I said, yeah, think so.
Josh Fessel, MD, PhD:You know, and the thing that grabbed me immediately was these are people that I had never worked directly with. In talking with everyone that I interviewed with that very first day, it was impressive to me that there was this group of people who were incredibly skilled scientists, who had the charge to keep at the front of their mind integrity and the growth of a particular area of science that we all cared about. In this case, it was the division of lung diseases at National Heart and Lung Blood Institute. It was the science first, and it didn't. All the other things that can become distractions were pushed to the side because it was science first, science always.
Josh Fessel, MD, PhD:Whether that meant the rigorous design of a clinical trial or the gross and nurturing of the scientific workforce, that was the mission. And it wasn't being this author or that author on the paper. It was, oh, there are all these other people who are doing what I want to do in science. And so it was an exciting day still looking back on it.
Catherine Batsford:And so that was pre COVID.
Josh Fessel, MD, PhD:It was. Yeah. This was in the 2018, and I moved to the NIH in September 2018. So I had a little over a year to really learn the job, which I'm incredibly grateful for, because it took a while to learn all of the acronyms, all of the different moving parts. Any large organization is fairly Byzantine from the outside, I think, and and it takes a while to learn it.
Josh Fessel, MD, PhD:And that's true. You know, it's sort of a a cliche in government. It's not that it's wrong. It's just that I actually think it's true of a big university or a big corporation, whatever. But it took a while to learn the ropes, I'm really glad I had that opportunity because, as you might imagine, when you're in the Division of Lung Diseases With the National Heart, Lung and Blood Institute.
Josh Fessel, MD, PhD:Yes. When a global public health catastrophe breaks out that primarily manifests in the lungs, you get incredibly busy overnight.
Catherine Batsford:Warm.
Josh Fessel, MD, PhD:And that happened. Wow.
Dan McLean:So take us back to that time. When did you know something was different? This was a big Boy,
Josh Fessel, MD, PhD:I think back to a conversation that I had. You know, this is something that we started talking about internally, probably as I'm trying to remember the first conversations. You know, we were plugged into some of the things we were hearing coming out of other parts of the world, I would say late in 2019. I'm trying to remember. There was a specific conversation that I had with a coworker who asked, Gosh, do you think we should be worried about this planning?
Josh Fessel, MD, PhD:Should we be getting a strategic stockpile of food and medical supplies and stuff at home? And I still laugh about this. I said, Oh, no, no, no, no, no. It's not going be anything like that. It's, you know, I mean, we might like this could be like the flu of the H1N1 of, you know, of 02/2009, which sort of stood out at the time in my mind as the benchmark for a really bad infectious disease public health event.
Josh Fessel, MD, PhD:I was a critical fellow at the time, and it left its mark on me and lots of other people. So I thought, it can't possibly get worse than that. I own how wrong I was about But, you know, we started talking about it early in 2019, and then obviously as things progressed, it became the dominant daily topic of conversation, figuring out how do we support response efforts? Do we support investigators? How do we support ongoing studies?
Josh Fessel, MD, PhD:How do we stand up the studies that we need to see happening, recognizing that the people who are the folks on the front lines doing those studies are also the people trying to keep people alive. And we don't know nearly. It was a really scary and intense time. We were laughing like when when does one sleep before we got on. And at that time, sleep didn't literally like meetings were happening at all hours of the day at night, partly because there was so much to do, partly because there were global coordination efforts.
Josh Fessel, MD, PhD:And if your colleagues in the European Union need to talk to you, then you do it when you can. I I hope we don't ever go there again. It was really something. It's not to say that good things didn't
Catherine Batsford:Have through the side.
Josh Fessel, MD, PhD:Get created. Yeah.
Catherine Batsford:Were there things that moved through quickly that maybe would have been stalled before or something you're particularly proud of that happened?
Josh Fessel, MD, PhD:Oh gosh. Before we could talk about that, I was privileged to be part of all manner of efforts that I feel are some of the highlights of my career. They were impactful, meaningful, did real good in the world, and they were shining examples of what happens when people come together and forget about, you know, the jersey that you might wear every day. We had a common unifying goal that didn't need upfront discussion. We didn't need to talk about, is this really important?
Josh Fessel, MD, PhD:Why is this important? Like, that all was not like we were there to get the good stuff done as quickly as we could, because no matter how quick it was, it wasn't going to feel quick enough. Several parts of ACTIVE Accelerating COVID-nineteen Therapeutic Interventions and Vaccines public private partnership that I was involved with are some of the most impressive things I've ever seen happen, where leaders from federal government across different agencies and leaders from the private sector across different companies around the world and leaders from academia across academic medical centers from around the country and around the world all came to be clinicians, scientists, epidemiologists, operations specialists, human subjects protections experts. You get everybody on a call at whatever time, however often it needs to happen to say, Okay, we need to get from wherever we are today to a completed study so that we know, is this intervention helpful or not? And if it is, then we need to start the discussions about how we're going to get it to people.
Josh Fessel, MD, PhD:And if it's not, then we need to start the discussions about, Okay, what do we do next? It was kind of an amazing time. It mirrored in some ways a lot of what drew me to critical care medicine early on. You get to focus on the fine details, but paint in broad strokes, if that makes sense. Mhmm.
Josh Fessel, MD, PhD:You're you're aiming at big targets, but you know that even tiny little things are gonna impact your success or failure. So you can you you figure out which of the tiny little things to perseverate on, which ones to try to let go, which team members to bring on board, and it's a team sport. And the stakes are high and you're making the best decisions you can with limited information. And then when you learn more, you adjust course and you get as close as you can to the right answer. And to see that happen at scale where, you know, literally the well-being of the country and it didn't feel like overstating it to say the world was part of the calculation.
Josh Fessel, MD, PhD:Like, that mad that's what we were thinking and talking about. So it was as we sit here and and think about it, I I can feel my heart rate going up because it was exciting, but it was scary and it was stressful too. It was all of the things. Yeah.
Catherine Batsford:It's that almost dream moment of when science comes together and moves fast. You think, oh, if we could do that with cancer, if we could do that, how much further could humanity go if we work together?
Josh Fessel, MD, PhD:It's a key point, and and I'll say two things about that. I'll say one, I think we learned that there are some things that there are opportunities to do things faster than whatever the status quo was in early twenty nineteen, before any of us knew what SARS CoV-two was. But I think we also learn well, I'll say three things. There are ways to do things faster, better, more efficiently, all that sort of thing. Second, that getting the right teams together is absolutely critical.
Josh Fessel, MD, PhD:I think everybody would have gotten the answer right on the quiz if you had asked that. But to see it live, to see it in real life and in real time was really dramatic. And then the third thing I'll say is that the things that worked in the pandemic, not all of them could be ported to normal operations. Of them some of the things that we were able to do are not sustainable as part of normal operations. You know, for example, I remember there were calls that were happening, regulatory agencies, for example, on a more than weekly basis, because that's how fast things needed to move.
Josh Fessel, MD, PhD:But there's no way that the FDA or the EMA or other regulatory agencies could sustain that level of engagement and output for all of the conditions that therapeutics and diagnostics are developed for across all of the I mean, it's just not there would never be enough people to do that. So I think we also learned that, you know, told somebody once that I could take care of my pulmonary clinic patients the same way I take care of my ICU patient, but I don't. And there are good reasons for not doing that. And so you match the effort to the task at hand. But, you know, to your point, there are lots of things I think that we learned that I was hopeful then, and I'm still hopeful now, that we could see moved into what a lot of us kind of independently arrived at as calling peacetime operations as opposed to pandemic.
Josh Fessel, MD, PhD:It was very striking to me how people, without sort of talking about it, we all kind of, you know, or I won't say we all, but many people started referring to the non pandemic time as peace time because the pandemic really did feel like going to war in some ways. I
Dan McLean:wonder if you could take a second to look back. It's now obviously 2025, and
Josh Fessel, MD, PhD:Mhmm.
Dan McLean:Parts of the pandemic seem a long time ago, and parts of it seem like yesterday. But for some, I think a lot of people gained a tremendous amount of respect and trust for the scientific enterprise and how quickly vaccines were developed. And for others, the opposite is true. And trust that they had eroded to a a high extent and has brought us to a bit of a polarized state. And I wonder what your perspective is on that now while we have had the passage of some time.
Josh Fessel, MD, PhD:That's a great question, and it's something I think a lot of us have thought a lot about, have spent time talking about, and we're going to need to spend more time talking about it. I think looking back, one of the huge, unmissable, for me at least, object lessons from the pandemic was that the element of trust and the requirement for trust is critical, central, indispensable, whatever superlative you want to use. Science and medicine don't work without trust. And I think we saw what it looks like when you try to do something really important for public health. And as you point out, Dan, we found places where we didn't have the necessary trust or we had lost it.
Josh Fessel, MD, PhD:And there are real public health implications for that. It's a tricky thing because there isn't like a metric for that, right? At least I mean, I'm sure there are probably, I don't know, are three dozen metrics for anything you want to talk about. But I can't send a lab test and know what somebody's trust level is. I can't take a pic, you know, take an x-ray and know what their trust is.
Josh Fessel, MD, PhD:It's a difficult thing to quantify, but we sure know when it's not there. You talk about elements of the pandemic that seem very distant and ones that seem very present and of the moment. And the trust one is one that is very present and of the moment for me and goes back a shared distance, at least to the beginning of the pandemic and for some folks well before that. I think we some of the hard work that we have ahead of us as we think about how we get biomedical research and public health to a place where we'd like to see it, Personally, I don't think it's where we want it to be right now. And I think we've got a lot of work to do to fix some things.
Josh Fessel, MD, PhD:I think that was I think that's gotten more true in the last nine months. One of the things that's going to have to be part of that, I think, is some very real, in-depth, difficult conversations about trust and mistrust and what that means and where it comes from and really get into the whys of it. One of the things that I used to say and I think a lot of people understood and recognized the importance of trust and being trustworthy in the aftermath of the pandemic. One of the things that I used to say on group calls when this would become a topic of conversation is that just saying the words trust and trustworthy a lot don't make it happen. You know Yeah, there's got to be a verb in there, right?
Josh Fessel, MD, PhD:Yeah, know, sticking feathers in your waistband doesn't make you a chicken. You actually have to do stuff to be trustworthy. And to know what to do, some of it we know, but some of it I think we some of the doing is going to be digging into what didn't go well and acknowledging that there were things that didn't go well, understanding why and then figuring out what is it that makes people angry? What is it that makes people scared? And addressing that Because until it's hard to trust somebody if you're mad at them.
Josh Fessel, MD, PhD:It's hard to trust somebody if you're afraid of them.
Catherine Batsford:Or if you don't know who they are. Mean, what's If you
Josh Fessel, MD, PhD:don't even know who they are.
Catherine Batsford:And as a young college student, you didn't know the NIH. Mean, it even stood for, let alone what they do.
Josh Fessel, MD, PhD:That's a 100% right. It starts with who are you? What who are you and what are you here for? What do you want? What do you like, why are we talking?
Josh Fessel, MD, PhD:Yeah. Yeah. Exactly. But that's exactly right. And we all have had that experience where somebody, you know, starts laying something on us and we go, wait a minute.
Josh Fessel, MD, PhD:I don't even I don't even know. Like, you need to tell me more before we go further here. Yeah, and I think that is an opportunity. I think all of the different components of the biomedical research and public health enterprise have an opportunity to really up our game in terms of letting people know, like, what do you do? And to do it in a way that people can go, Oh, Okay, yeah, I get it.
Josh Fessel, MD, PhD:Like, you know, I understand, I think, what that is and why that might be important. And I think there I think it's a teachable skill set to help people understand how to talk about epidemiology in a way that that, you know, people can click with, to talk about drug development in a way that doesn't make people that avoids the glaze factor. And but I think it's not something that we have necessarily focused on as a as a cultivated skill and as a rewarded skill in a lot of cases. And I think that's something that could be improved upon quite a bit. Everybody loves a good story.
Josh Fessel, MD, PhD:If you can make it, you know, and the truth is told in story form. And so if you can make it a story that people go, Oh yeah, I recognize the features of that and I see something that matters to me in that, suddenly it's not quite so scary. You know? Or if it is, it's easier to talk about the scary bits.
Catherine Batsford:So on that a little bit, reflecting on your role as a director of the Office of translational medicine at NACATF. Lessons can you pass along about navigating ethical conflicts in a large scale, multi institutional research collaborations? This is getting kind of weedy for our, some of our listeners. But also in layman's terms, can you explain translational medicine for everybody?
Josh Fessel, MD, PhD:Boy, that was something that I that was, like, the first task that I worked on when I when I was fortunate enough to take the reins of the office of translational medicine. Because even people within NCATS were like, Wait, so what is that? And if you asked a dozen different people, you'd get about a dozen different answers. The way I tried to crystallize it was that, Well, okay, medicine is in the name of the office, and we're the only part of NCATS that had medicine as part of our title. So that must tell us something about what it is that the office does.
Josh Fessel, MD, PhD:And medicine means people, right? If people aren't involved, you aren't doing medicine. That's a little bit of an oversimplification, but if you'll permit me. The practice of medicine needs to have people involved. I think we can settle on
Catherine Batsford:it. So
Josh Fessel, MD, PhD:the way I talked about translational medicine was we concerned ourselves in the Office of Translational Medicine with how do you get from good idea to a thing that's actually able to help people when they need help, where they need help, in a way that they can access. That's pretty general, but it actually turned out to capture pretty well what the office did. And so that's the part one. Part two, the comma and is think about ways that you can innovate on that pipeline, right? Or on that process to more quickly, more cost effectively, more efficiently, more equitably get from good idea to thing that helps people.
Josh Fessel, MD, PhD:Because there's a lot of science that can happen in there. And actually, lot of it that I think is is relevant to our from our audiences is, you know, one of the things that we thought a lot about was ways to innovate in the ethics space that, you know, so to get a little weedy about it, the NCAT funding portfolio is a little different than a lot of the other parts of NIH. And the main difference is that the grant that most people are most familiar with, the R01 grant, NCATs actually only has a very tiny R01 portfolio. Most of the funding that goes to investigators through NCATS goes by way of other funding mechanisms. The main RO1 portfolio that existed or exists at NCATS is the translational bioethics research portfolio, and that lived in the Office of Translational Medicine.
Josh Fessel, MD, PhD:So we did concern ourselves with thinking about how to innovate in that ethics space and not just navigating existing conflicts. We did plenty of that, too. Or questions, maybe. But how to how to push the frontier of the thinking and the activities in bioethics? As you might imagine, A.
Josh Fessel, MD, PhD:I. Comes into those discussions a lot these days, as it should, in my admittedly biased opinion. But there are other things that fit in there, too, when you're thinking about rare diseases, for example. And cats did a lot of rare diseases work. And, you know, it gets really interesting when you think about the ethics of a clinical trial for gene therapy, particularly if you're talking about gene therapy that uses modified virus to deliver the material that's going to correct the defective gene, because our immune systems are really good at recognizing viruses.
Josh Fessel, MD, PhD:And that's not different if you're talking about delivery of a payload that's going to fix a defective or a malfunctioning gene. That becomes interesting ethically when you think about and important ethically when you think about the design of a clinical trial, because you can't get repeated dosage. No. It's very different than a small molecule. And so suddenly this very fundamental feature, when we think about escalating doses and maximum tolerated dose and all that stuff, that means something totally different.
Josh Fessel, MD, PhD:And you think about it in a totally different way. And really, people need to understand at the very beginning what their participation in a trial like that might mean for their future self. And so those automatically become very different discussions. And so we helped think through how do you explain these? Fairly complex concepts to a bunch of different people, all of whom need to understand it, and in a way that they really can understand and can ask questions and can be truly informed, whether they're thinking about participating in the trial or whether they're thinking about materials that communicate about the trial to a larger, more general audience.
Josh Fessel, MD, PhD:So we did, you know, we did a lot of that kind of thing as well. But yeah, I'm trying to think of a great example of an ethical conundrum or an ethical an example of an ethical question that came up from the clinical research realm that exemplified the kind of work that we did, but that I could talk about without divulging many I'm not sure I have one that readily comes to mind. But like I say, it's not a discussion of biomedical research these days if we don't say AI out loud. That was actually one that popped up a lot. There's fascinating ethical questions that are coming up with that, and more that should be, I think.
Dan McLean:So speaking of AI, Josh, I did have something for you on that. The use of AI in biomedical and healthcare settings is growing rapidly. What, in your view, are the key ethical guardrails that we need to establish to ensure AI systems are used responsibly and don't exacerbate health inequities or introduce bias or research into clinical care?
Josh Fessel, MD, PhD:Yeah, boy. If I had the exact right answer to that, we should start a company right now. I guess a lot of people kind of are, but it's a really important question. I think there are a few things that are top of mind important for me. Just because you can bring AI to a situation, question, problem, what have you, doesn't necessarily mean that you should or that you need it.
Josh Fessel, MD, PhD:There's a tendency to want to A. I. At things. You know, we'll do A. I.
Josh Fessel, MD, PhD:To it and that will solve X, Y, Z. And and I think sometimes that might be true. Plenty of times, I'm not sure it's true. So I think you have to just like with anything, you have to pick the right tool for the right situation. AI enabled solutions are tools.
Josh Fessel, MD, PhD:So that's the first thing. The second thing is we are learning while doing. And I think that means that we need to be continuously mindful of if we we're using an AI enabled tool in whatever scenario, clinical decision support, recruitment enhancement for clinical studies, whatever, there needs to be ongoing close assessment of how that tool is performing. And I think we need to be very mindful about detection of emerging features that were not present in the off the shelf performance of the thing, right? So bias, if somebody says, all right, this has been pressure tested for bias detection in the algorithm or whatever, that's great as a starting point.
Josh Fessel, MD, PhD:But you got to keep got to keep after it. You got to keep no one would ever be satisfied with a hospital that said, well, we did patient safety and quality improvement, so we're good. What do mean you did it? It's not done. It's a thing you do, not a thing you did.
Josh Fessel, MD, PhD:And I think AI is exactly the same, right? I mean, even the clinicians don't get away with that, right? Clinicians have to maintain some level of education and demonstrable currency of knowledge and demonstrable acceptability of performance. Any of your tools should be no different. It's also true of the assays that are being run-in the clinical lab.
Josh Fessel, MD, PhD:Those are QC'd regularly. So I think that's a really important part. And then I think being really open about how these tools are being used and how they're being overseen and governed. I was talking with somebody the other day, and I said, It would be an interesting experiment to go to wherever we receive our healthcare and say, Can you tell me all of the things that are done with my healthcare data?
Catherine Batsford:No, I haven't.
Josh Fessel, MD, PhD:And I think people would get a variety of answers. You know, when I'd be talking to an audience of folks in the health AI space, I would say, Okay, show of hands. How many of you have A. I.-enabled tools being used as part of your own health care? Do you know?
Josh Fessel, MD, PhD:Do you want to know? Does that bother you? How do you feel about that? And I think it's really important, you know, particularly when we are talking about you know, there was a study that's in the preprint literature, currently it's on archive, where they were looking at the appearance over time of or disappearance, I should say, over time of disclaimers regarding medical interaction. Know, generative AI large language models used to be very good about sit well.
Josh Fessel, MD, PhD:Very good. Used to be better about saying, you know, Hey, not a doctor. This isn't medical advice. Those disclaimers have steadily decreased over the last several years to, in this study, if I remember correctly, it's below single digit percentages in terms of appearance and detection of these disclaimers. That's a problem.
Josh Fessel, MD, PhD:Because, you know, the way I've tried to frame this up for people wanting to use, you know, pick your favorite LLM for medical type stuff is, we know that generative AI algorithms will fabricate results, hallucinate, if you like. We know that there is, you know, sycophancy is a feature that's been studied. They will tell you what you want to hear. So if I told you that was true of a physician, would you trust that doctor? I wouldn't.
Josh Fessel, MD, PhD:No. But we're totally comfortable. Yeah, well, we. Some people are totally comfortable having those interactions with, you know, again, pick your favorite LLM. So I think that's telling us something about where we might make improvements in healthcare, but I think it's also telling us something about where there's risk that needs to be recognized, measured, and mitigated.
Catherine Batsford:And that feeds right into, do you think the current regulations are sufficient? And do you think there's some new frameworks needed to protect people?
Josh Fessel, MD, PhD:Short answer is yes. I do. But, boy, that gets to be a sticky conversation. But, like, it should be. Like, if were straightforward, we'd have solved it already.
Josh Fessel, MD, PhD:You know, it there are a ton of frameworks that are out there. They're probably all useful in certain contexts, much like the AI algorithms that they want to regulate. I think understanding where risk exists, where it can come from, where utility exists, and where currently, where hype exists are really important. I think it's really difficult to write a regulation that has the effect and this is true of whatever we're talking about. I think it's really difficult to write a regulation that has the effect of the desired effect of protecting people from harm, however we're defining harm.
Josh Fessel, MD, PhD:But also allows for sufficient room for innovation, research and development. And I think that's absolutely true in the health AI space, because it's moving so fast. If you said, All right, you're not getting off this podcast until you write the bones of a regulation, I'd say, Okay, well, Oh I'll give it a gosh, I don't think any of us want that. I'd say, Okay, I'll give it my best shot. But the tenant number one is going to be revisit this regularly and be prepared for it to change, because whatever is in place now may very well not fit the situation in three months or six months or even sooner.
Catherine Batsford:So can you speak a little bit more about your tenure at NIH and why you decided to step down?
Josh Fessel, MD, PhD:Yeah. Yeah, absolutely. So we talked about how I got to NIH. Yeah. It was kind of an accident, but on day one, you know, interview day one, so day zero, I guess, kind of fell in love with the place.
Josh Fessel, MD, PhD:And so started my time at NIH as a medical officer in the Division of Lung Diseases at the Heart, Lung, Blood Institute. And a lot of that began as learning the ropes, learning how to be a program director at NIH, how to oversee a segment of the scientific landscape, how to oversee the portfolio from a scientific point of view, how to write new funding opportunities and move them forward to the point where they're actually ready to start supporting new grants. So a lot of nuts and bolts operational stuff. I also had the chance to really grow my clinical research experience in that role because coming into NIH, I was very much a chemicals in test tubes, cells in dishes, mice in cages kind of scientist. And I partnered with clinical investigators.
Josh Fessel, MD, PhD:Know, I might anonymize volumes of juice in little tubes, but I was not doing clinical trials. So it was really exciting and fun when I moved to NIH to learn how to oversee clinical trials, to learn how data and safety monitoring boards work, to learn some of the ins and outs of IRB operations and all that kind of thing, really get into it. So I greatly expanded my skill set and my ability to contribute to the science that NIH does. I also came with a mission to get meaningfully involved in the data science piece of what was happening at NIH. I, as a chemicals in test tube, cells in dishes, mice in cages scientist, had had the great good fortune to work with people who were card carrying data scientists when I was on faculty before coming to NIH, and I got to see it was very understandable to me how an electronic health record derived database could be informative for clinical questions.
Josh Fessel, MD, PhD:What I had never really thought about until I got the chance to do it was how that could also inform the kind of basic science that I did. One of the collaborations I had with somebody at the Heartland Blood Institute was this investigator had created a Franken mouse where a genetic pathway had been manipulated and there was an interesting phenotype that came out of it. And the question was, is there any evidence that anything like this happens in people? And as it turned out, the data resources existed such that there were clinical records fully de identified and hashed nine ways to Sunday, along with genetic data, again hashed nine ways to Sunday, so no way to figure out who these people are. But what we could figure out was that, yeah, when there were alterations a couple of the relevant genes in the pathway, there were detectable clinical signals that looked kind of like what was being observed in the mouse model.
Josh Fessel, MD, PhD:And that was, A, mind blowingly cool and, B, a thing that could never have been done in a prospective way. You would never have built a data set to address that question, nor could you. And maybe nor should you, at least without information to point you in that direction. That would it would be expensive. It would be hard.
Josh Fessel, MD, PhD:It would take a long time and it would be a big gamble. But with well designed big data resources, it's a question that could be answered in weeks and really impactfully so. And we did that several times with different studies before I came to. So I wanted to expand that capability if I could when I came to NIH to try to help people plug into more of that. It didn't seem right.
Josh Fessel, MD, PhD:I should get fired up about that, but where very few other people could, let's make that available to everybody. So that was part of what I wanted to do and got to work on some of that and then really got to dig into that after I moved from heart lung and blood to NCATS. That move happened in the midst of the pandemic. It was really another one of those fun happenstance kinds of things. I worked with a bunch of people from NCATS on various pandemic response efforts.
Josh Fessel, MD, PhD:And at the beginning of the pandemic, I remember saying, Who are NCATS? Like, I've never heard of these people. You know, and suddenly I'm on multiple calls a day with them and wow, they really have their act together. Like, very impressive. And thinking about things in a really exciting way, like not disease focus, but but more like a bigger picture thinking or, know, not constrained by, well, it's a lung thing or it's a nervous system thing or whatever.
Josh Fessel, MD, PhD:It's a it's a it's an operations question or it's a it's a question of how do we get from here to there and think over around or through the problems that exist between where we are now and where we're trying to get to. And I was like, wow, they're like, there's a place that does that as their main sort of focus. And it turns out, yeah, there is. So when their position came open at NCATS, I applied for it, was lucky enough to get it. And part of what I got to do was to really dig deeper into that data science effort with mainly working with the, what was at the time, the National COVID Cohort Collaborative, what has now been reimagined as the National Clinical Cohort Collaborative.
Josh Fessel, MD, PhD:But to really, as I say, put wheels on or a big data resource to drive discovery at a pace that couldn't be done otherwise. And that was really that was really exciting. I talked about, you know, getting to be involved more with human subjects protection efforts, and I was lucky enough to be part of the team working with the Smart IRB program. I really got to see, know, I was the federal task lead for Smart IRB, I got to see and help shepherd that program along with all of the you know, with the team at Harvard and the team at in the IT department at NCATS and all the other folks that lean in to make Smart IRB the success that it is. And that was another great example.
Josh Fessel, MD, PhD:Was actually one of those great quote unquote peacetime examples of the big things you can get done when a whole bunch of people come together to focus on a thing that's really important and how you can even get departments of the federal government to work together, the Department of Health and Human Services, Department of Veterans Affairs, the Department of Energy, the Department of Defense, like, you know, mean, it kind of makes your head explode that it's even possible to do that. So that was my you know, that kind of characterizes what my tenure at the NIH was like. It was a whole lot. It is a whole lot of really dedicated, passionate people who want the science to do well. The reason that I chose to leave was that I was for me.
Josh Fessel, MD, PhD:The things that were coming from the new executive branch leadership and Department of Health and Human Services leadership really were not compatible with my own internal moral compass, were not compatible, I felt, with my oath of federal service and were not compatible with my oath as a physician. To get specific about it, when there are directives to remove language, remove any mention of gender ideologies, to scrub federal documents of quote unquote DEI language, whatever that means, what you're the way that that sat for me, the way that that felt to me is that that's an effort to erase people. Real people, some of whom are my family members and some of whom are my loved ones, many of whom are my friends and all of whom I serve. And that's not Okay. And and I can't I can't I couldn't be a part of that.
Josh Fessel, MD, PhD:And so that's what led to the very difficult decision to step away and to, you know, with the idea that I'm going to use this time to do what I can to push for what I believe to be the right things to do for science, for medicine, for people. And when it's time to really start putting things back together in earnest, I want to have a better skill set than I had when I left, and I intend to be the first in line to help with that. And in the meantime, also try to support my friends and colleagues that are still trying to keep things working, because that's important too.
Catherine Batsford:Yeah.
Josh Fessel, MD, PhD:Yeah. One of the things that I try to take every opportunity to say is that all of the people that you have known and worked with for a long time at the NIH or the FDA or the CDC or any of the agencies, they're the same good people they've always been. That part hasn't changed. And so I think it's going to be really important to be extremely intentional about restoring trust in these agencies. It's been eroded, it's being eroded, and those are very that's understandable.
Josh Fessel, MD, PhD:But we're going to I feel like those agencies have to be there, and there has to be trust in them. It has to be earned trust. So, you know, the people that are there are still good people changed. There are many, many, many, many people who are in these agencies, who have been in these agencies, who, if given the opportunity to make those positive changes, would start this moment. And so we have to I think we have to make the space for that to happen, however whatever that looks like.
Josh Fessel, MD, PhD:And then follow-up with some of the things that we've already been talking about. Do a better job of making sure people understand what do you what do you all do at NIH? What do you all do at FDA? Like, what is that like? That's a part of it, too.
Dan McLean:And one and one of the things you wrote about, and you mentioned it earlier in our conversation, was that it's really important to tell the stories of the science and the scientists and all the professionals who are part of public health. So, I mean, that's kind of one of the things we're we're doing right now and and you are. But I wonder if you have other ideas or colleagues out in the field that you can help to amplify that.
Josh Fessel, MD, PhD:Yeah, absolutely. Thank you for that. And and thank you for making the space to talk today. Yeah, I said earlier, the truth is told in story form. And people are moved by stories, not by data alone.
Josh Fessel, MD, PhD:If they were, we wouldn't bother to have words in our scientific papers. It would just be the figures. The stories matter. There are lots of people out there that are doing really great work to amplify the stories of federal workers, not just from Health and Human Services, but across the federal government, who have been either told that they're not allowed to do their job or have found it incompatible with their own moral compass, or they, you know, for whatever reason, are no longer part of the public service workforce in the federal government. So, you know, and I see resources popping up or I see things popping up all the time to try to share the stories of folks.
Josh Fessel, MD, PhD:I will say that I think one thing that could enhance that is certainly people that are still in the federal government have some understandable anxiety about speaking up. And I think that's true even for people who have left. Because you still have to solve the problem of like, how do I pay my electric bill? How do I buy groceries? And all that kind of thing.
Josh Fessel, MD, PhD:And I think people are some people are understandably hesitant to to share stories that may that they feel like may make them a target or even just may sound overly negative that may, you know, exclude them from employment opportunities or whatever. And I think that's all as a community. If we can think about ways to make those stories safer for people to tell and keep a very wide aperture for what we think about when we think about storytelling. Making them accessible in a way that lots of people can get to through print media, through podcasts, through televised media, through all of that. That's really important.
Josh Fessel, MD, PhD:But also, you know, the one on one conversations really matter, too. And, you know, to be able to say, Oh yeah, I was talking to my friend who used to work at CDC and now doesn't. Or I was talking to you know, my sister used to work at the State Department and now doesn't because, you know, those are impactful, too. I think it needs all of those so that collectively we remember what we what the public service workforce offers in the federal government, why we need it, why it's super important for the health of the country, and so that when so that we not only remember what the federal biomedical and public health workforce is supposed to be, but so that we can better communicate it, again, to the people who may not have understood it fully to begin with. But if we've got these stories that we can share, not just about what has happened, but what ought to be happening, it becomes, I hope, a bigger snowball that we're building to to get get it cemented in people's minds that, well, yeah, we actually do need a strong, vibrant, diverse research workforce, a strong, vibrant, diverse public health workforce.
Josh Fessel, MD, PhD:That's how we maintain economic health. That's how we maintain bodily health. That's how we maintain population health. That's how we maintain national security. I could go on and on.
Josh Fessel, MD, PhD:But, you know, it it's all in there, I think.
Catherine Batsford:What advice would you give to young researchers facing the funding cuts and the uncertainty in this this new maybe not new. I think things like this have happened in the past. It's a pain pressing element right now, but any advice to give them as they're watching this unfold?
Josh Fessel, MD, PhD:Well, that's so hard. Thing one is that a career in science and medicine is worth pursuing. It's incredibly rewarding. It's incredibly important. It's incredibly impactful.
Josh Fessel, MD, PhD:It's incredibly meaningful. It's gotten me out of bed every day for decades now and will continue to do so until I can't do it anymore. To early career folks, I would say, think very flexibly about what career success could look like for you. We got really comfortable as an enterprise with saying, Okay, well, you know, there's a there's a well worn path to success. You you know, you write your career development award and then you write your R01 and then you write another R01 and, you know, repeat until retired or dead.
Josh Fessel, MD, PhD:And that can work. But But that's a really that model only works when you don't have to be that creative about how careers unfold and progress. And so I think, to the early career folks, I would say, think very flexibly about what you feel is success. If it's running an NIH funded lab, awesome. The NIH exists.
Josh Fessel, MD, PhD:Federally supported research still exists. So that's great. But there are lots of other ways to do research in the biomedical and public health spheres. There are lots of other ways to contribute meaningfully in the biomedical and public health spheres. I think if I were early enough in my career and I had the degree of flexibility required, I would say take a global view.
Josh Fessel, MD, PhD:The only thing that makes me sadder than thinking about a really talented scientist leaving The United States is a really talented scientist who never actually pursue science at all. And so if that means that that you get to follow your dream of being a scientist by pursuing it, at least for a time in a country outside The United States, Okay, the world is still better and you're still doing the thing that matters to you. So yeah, so I would say stay flexible in that thinking and consider what what all of the different definitions of winning might look like for you. The other thing that I say in that very same breath is speaking to the institutional leaders, the people who have as part of their charge stewardship of the scientific workforce, protect the early career people, because we have never been very good at providing on ramps back to the research pathway when somebody has picked a different professional trajectory. I think we're going to need to get good at that better than we have been in the past.
Josh Fessel, MD, PhD:And helping people get a strong start so that they don't have to make the choice of, you know, I pursue a career in research or I do this other thing. And that's going to be really, really hard. But a few degrees of course correction early in a career translates to miles of difference ten years, twenty years down the line. The cohort effect for the young scientists now is huge, and we'll be living with that for as long as they might have been contributing to scientific discoveries.
Catherine Batsford:Well, Dan, do you have any last questions?
Dan McLean:No. I don't. I think we we covered a fair bit of terrain, and I thought
Josh Fessel, MD, PhD:that was a
Dan McLean:great conversation. I did wanna note that you'll be our one of our speakers in Baltimore coming up for Primer twenty five, so thank you for being a part of that. Look forward to meeting Oh, you
Josh Fessel, MD, PhD:thank you. No. I'm so excited about that. I literally had to read that email a few times to make sure it hadn't gone to the wrong person. Like, I was sure it went to the wrong person.
Josh Fessel, MD, PhD:So I am totally jazzed about that. I can't wait to see you there. I can't wait to see everybody else there. Yeah, as we've seen, we got a lot to talk about. We got a lot to do.
Josh Fessel, MD, PhD:So let's get at it.
Catherine Batsford:Well, thank you so much. This was amazing, and excited to get this out.
Josh Fessel, MD, PhD:Thank you so much. This is great.