番茄社区

In this first of two exclusive video interviews, 番茄社区 editor-in-chief Jeremy Faust, MD, talks with Monica Bertagnolli, MD, the 17th director of the National Institutes of Health (NIH), about her role as NIH director, her background as an industry researcher, and the importance of data transparency.

The following is a transcript of their remarks:

Faust: Hello, this is Jeremy Faust, editor-in-chief of 番茄社区. We're joined today by Dr. Monica Bertagnolli, who is the 17th director of the National Institutes of Health, the NIH. She was nominated by President Biden in May of 2013, and confirmed in November. She's the first surgeon and the second woman to hold the position. Director Monica Bertagnolli, thank you so much for joining us.

Bertagnolli: It's my pleasure to be here.

Faust: Let's start in with some NIH-specific questions. In your position, what levers do you have as opposed to the levers, maybe a level or two down. Sometimes the decisions are made in these meetings and then they flow up top. What are some of the levers that you've been surprised that you pull in your position?

Bertagnolli: Oh, goodness. So I serve as the director of 27 different institutes and centers at NIH. Each of those institutes and centers has a director that is really charged with running their entire program based on congressional authorization for the work that they do. So from my post, I think the most exciting thing about what the office of the director intends to achieve is really the coordination of big projects that impact all of those institutes and centers, or at least as many of them as possible.

Faust: Can you give us just a for instance, it's a very medical audience here, so we'd love to know what's something that came across your desk that you thought, oh, I never really thought I'd have to think about that.

Bertagnolli: Oh, I'll give you one. The National Library of Medicine [NLM], we all know that really well. PubMed, clinical trials.gov, all of the different services provided by the National Library of Medicine. But what the director has an opportunity to do is to think about the NLM and what it might be able to provide in the future. Specifically, can we spearhead some new programs for data science, new data analytics, and training in their use and proper application to health data? And can we use the NLM as a source of access to diverse data sets and perhaps even an environment where data sharing and use becomes the norm?

Faust: And what were they asking you about that? That's very interesting.

Bertagnolli: Well, it's a project that came up from various levels of discussion because shortly after my arrival, or actually shortly before my arrival, the director of the National Library of Medicine, Dr. Patti Brennan, who really articulated this vision a couple of years ago in a strategic plan, decided to retire. And so after setting this vision for us, we are now in the position of searching for a new director. So I think everybody across the NIH looked at that as an opportunity to maybe think differently about what the NLM might be able to do.

Faust: I think a lot of our viewers are familiar with a lot of the famous heads, whether it's you or the other agencies, but there's always a little bit of confusion on what everyone does. And there was a lot of controversy during your nomination process about drug pricing. But I'm not sure people really understand. Does the NIH have any role in drug pricing?

Bertagnolli: No, not that I know of, frankly. What NIH does is fund awards to the extramural community, academic institutions and nonprofit companies, and in certain cases, industry to conduct biomedical research. And those awards are governed under something called the Bayh-Dole Act, which means that NIH is assigning the ability to license and the intellectual property to our grantees. What NIH does have is an intramural program that really is the only setting where NIH would directly grant a license to another party for some activity, and that is the only place where NIH might be able to introduce clauses in those licensing agreements that could address almost any kind of access, including eventually pricing.

Faust: My interpretation here was that regardless of the merits on drug pricing, which is a big issue for our entire system, it was a bit of a non-sequitur to hold up an NIH director position on those grounds. Is that fair?

Bertagnolli: Oh, I don't know. I think anything that the NIH has a role in is fair game when a confirmation hearing is occurring. And I do know that drug pricing and access to therapies, many of which come funded at some level from NIH funding, I think it's fair to question whether the American people are getting a fair return on their investment from pharma and other industry outlets for the research that the federal government pays for.

Faust: Okay. And yet, NIH doesn't have a huge hand in this. But perception is reality, and maybe that was what was behind Senator Sanders's opposition eventually voting against your confirmation, surprisingly. But I do wonder if optics matter here. You had a long and successful research career with millions of dollars in support from Pfizer, from AstraZeneca, and these led to important contributions that really propelled your career and to your position. What would you say to critics who think that the head of the NIH maybe shouldn't be so cozy, or at least in the background, with some of these companies?

Bertagnolli: Oh, I think my responsibility as the head of the NIH is to achieve the fullest possible access to all new approaches, technologies, therapies, prevention modalities for people. And so the end is critically important. It's very important that NIH be able to work with industry because otherwise, the American people wouldn't have access to any of these important treatments and devices. So I think it's a very important part of the job to understand that relationship and to foster it in a proper way so that people can get what they need.

Faust: Switching to that now, it's relatively new in your tenure. You have some control over the way things go, and I'd like you to tell us a little bit about some of the biomedical funding priorities that you have, some of the changes that have happened over time, and where you see things headed. Where are some of the course corrections on where our public funding should go?

Bertagnolli: Well, I can tell you one of the things that is most exciting to me personally about what's going on at NIH is a real willingness across all of the different institutes and centers to work together for some really important strategic aims that can only be achieved if all of us come together to eliminate silos and work together. One of them, I'm sure is not a surprise to anyone that's in the data space. We have an enormous wealth of data in biomedical research. We've got to be able to bring it into use. We've got to be able to link it to data from the clinical care environment so that we know how to turn it into advantages for people. And I'm very pleased to see a great willingness across all the institutes and centers to work together on these activities.

Faust: Do you think that data that comes out of NIH funded research should be more widely available? Because I do think there is some degree of, "It's our grant, we got the data, leave us alone, we'll tell you what it means." But this is public data in the sense of our tax dollars paid for it. So should there be a little bit more of a liberalization in terms of what happens to this data?

Bertagnolli: Well, that's already taken place. So as of January 2023, there is a requirement that any NIH-funded researcher provide the data generated by that research, provide a plan for how that data can be shared with the broad biomedical research community. Obviously, there are some instances where there are some appropriate authorizations that are required for data access, but the general spirit of it is to make sure all of the data is available as broadly as possible for biomedical research.

Faust: But when they drag their feet, where's the teeth? Because I just wonder, on behalf of many researchers, what do we do when we're going down that path, trying to get that data, and we're running into brick walls?

Bertagnolli: Yeah, no, I agree. Again, if the data is the result of a grant from the NIH, the data is required to be accessible, and we will hold our grantees to that. What we do need to do first, however, is to make it possible for data to be shared. This is one of the critical initiatives at NIH right now, frankly, we need an upgrade of our infrastructure, our ability to make data easily accessible to the broadest possible research community, and to also, frankly, provide access to analytic tools that will make research using secondary data analysis possible.

Faust: I know that you're reiterating the fact that you're not industry and that the NIH is literally the opposite of the industry. But at the same time on these grants that everyone applies for, the referees are very, very often tightly aligned, if not on the payroll for some pharmaceutical companies. And I just wonder, is there a way forward where there's a little more transparency on who is on these committees, why, and whether or not there's recusals? Because I think at times, again, there's this perception that it's not quite as independent as it ought to be.

Bertagnolli: Well, I think we do our best. We have policies to avoid conflict of interest, and those are very carefully adhered to. So I think like all institutions, both academic- and research-oriented, we work off of transparency and avoidance of conflict of interest in the review process. That's really the most important approach to take.

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