Azita Emami: Educating Nurse-Leaders

Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.‌

Howard Forman: And I’m Howie Forman. We’re physicians and professors at Yale University. We’re trying to get closer to the truth about health and healthcare.‌

Our guest today is Dean Azita Emami, but first, we always check in on current or hot topics in health and healthcare. And there’s so much going on, Harlan, that I’m not even sure what you’re going to cover today, so tell us.‌

Harlan Krumholz: Oh, come on. You begged me to cover this story, which is an article—‌

Howard Forman: Oh, good.‌

Harlan Krumholz: ... that I was on. And you know I don’t like to be self-promotional.‌

Howard Forman: No, no. It’s a great student that we both know.‌

Harlan Krumholz: Kushal Kadakia, who’s a medical resident at Mass General right now and was a medical student at Harvard, led this study, did a fantastic job. I’ve worked with Joe Ross and another former Yale student, Vinay Rathi, who is now at Ohio State, and others. We put this together, and it’s about breakthrough device program at the FDA.‌

Now, I just wanted to unpack this a little bit for folks. Over the last couple of decades, the FDA introduced several programs to get promising new treatments to patients faster. And it really started with drugs. They had all these categories. Fast track, priority review, accelerated approval, breakthrough therapy. All of them designed to speed up access for serious conditions, especially when options are limited.‌

In 2016, Congress created a version of this for devices called the Breakthrough Devices Program, and the idea was to promote innovation, and again, same kind of thing. Help patients with serious illness get access to these devices faster.‌

And that is a noble goal, but the question we ask is, in the rush to get these to markets, what’s actually happening? What kind of evidence is being generated? What kind of decisions are being made? And it always sort of drove me crazy, because the companies sometimes promote this idea, “We’re a breakthrough device,” but actually it doesn’t mean anything except that you got into the program and they’re evaluating you.‌

So how do you exactly... Let me maybe explain this. How do you get into this Breakthrough Devices Program? Well, the device has to be intended for a serious or life-threatening condition—heart failure, neurologic disease, cancer—and then it has to meet one of four criteria. It has to be a novel technology or there are no options available, so it’s the only option for this. Or it offers a meaningful improvement over existing alternatives or it’s deemed to be in the best interest of patients.‌

But listen to that. The first two means novel technology. That doesn’t mean it works, doesn’t mean it’s any good. So you can be accepted into the Breakthrough Program just because you have a novel technology and it’s addressing something in a serious illness, or just because it’s the only option available. It’s not an endorsement by the FDA. And that’s where I think the public sometimes gets confused.‌

A product is called a breakthrough device, meaning it’s in the Breakthrough Device Program, but that doesn’t mean anything about whether it has had any clinical testing. And it’s no endorsement by the FDA. In fact, most of these companies apply early, even before any human studies have begun. And then once in the program, this is what the advantage is, they get more attention from the FDA. Faster reviews, more flexible study. All that’s great for moving it ahead.‌

So, in this study led by Kushal, which was published in JAMA Internal Medicine, we looked at 75 therapeutic devices that got FDA approval through the Breakthrough Program between 2016 and 2024. And here’s what we found. About 1 in 10 of these devices that then went into being sold after going through this program had no clinical testing before their approval. And almost half of them where they did have some data used surrogate markers as their main outcome.‌

So what are surrogate markers? Well, they’re not like death or hospitalization. They’re things like imaging or lab results, but not actual patient outcomes. One in five of the devices had a study, but failed their trial. They didn’t reach their primary outcome, but they were still approved.‌

And then 60% of these devices, after they’re being approved, were not required to do any post-market studies. So again, people, this is a term of art: “post-market studies.” All it means is, once it’s being put out into the market, is the FDA requiring any systematic data collection to ensure it’s doing what it’s supposed to be doing and that it’s safe?‌

Kushal was quoted in Stat News on this, saying that if it feels abnormal to come to breakthrough devices and they’re supposed to be addressing unmet needs, and really, when you look at it, they’re authorized without any clinical testing—at least some of them. And then this idea that they were sort of speeding it up, but maybe we’re skipping steps.‌

I think a lot of us have been advocating for just more evidence that we think we can get in highly efficient ways so that patients and their doctors can be making informed choices once these devices get to the market. But often, it’s just not happening that way. And we’re writing a lot about this.‌

So anyway, Howie, I thought it was kind of an interesting study.‌

Howard Forman: Yeah, no, and it just speaks to the fact that our approval for devices, even though it goes through the FDA, is a very different process than it is for drugs. And our standards are different. And there are a host of things, many of which you have also researched and spoken about on the podcast, that just highlight this for us.‌

Harlan Krumholz: Well, in another paper that we did, the same group, we had done another paper where we looked at devices that had Class I recalls.‌

Howard Forman: Recalls, yup.‌

Harlan Krumholz: That’s the most serious level of recall. I think we’ve even talked about it.‌

Howard Forman: Yeah, we did.‌

Harlan Krumholz: This is the one where it could be life-threatening. And most of those had been approved or authorized with little or no pre-market clinical testing. And this authorization goes through this 510K pathway that we sometimes talk about that it’s having substantial equivalence to previously existing devices.‌

But look, these devices that go through the Breakthrough, there really is no prior predicate, they call it. There’s no prior device that looks like it because something new about them. There’s something new about them.‌

So anyway, none of this will be a call to slow innovation. We want to speed it, but “breakthrough” should mean something. And when the FDA uses the word, it should reflect not just hope but some evidence. And that’s what we’ve been trying to call for.‌

Howard Forman: Yup. Very good. Thank you.‌

Harlan Krumholz: Hey, let’s get on to our guest, the Dean of the School of Nursing. This should be really interesting.‌

Howard Forman: Dr. Azita Emami is the Linda Koch Lorimer Professor of Nursing and the dean of the Yale School of Nursing. She’s a trustee of the Robert Wood Johnson Foundation and a fellow of the American Academy of Nursing, where she also serves on the board of directors.‌

In 2021, Dr. Emami initiated the creation of the nation’s first center for anti-racism in nursing. Her research covers a wide range of topics, including dementia care, cross-cultural care, cultural competence in clinical nursing, and immigrant healthcare policy.‌

Her dementia research is internationally recognized, especially for developing a method to collect oral data for stress biomarkers. Dr. Emami received her bachelor’s degree in nursing and her doctorate in medical sciences from the Karolinska Institute in Sweden. She received her master’s degree in international healthcare from Karolinska and the Red Cross College of Nursing.‌

So, first of all, I just want to welcome you to the podcast. We’ve been really enthusiastic about having you join us. You are the dean at Yale’s Nursing School and, as such, really play an incredibly important leadership role in the field of nursing right now.‌

I want to just start off because one of the things, the feedback we get, Harlan and I, frequently is why don’t we have more nurses on here? I’ll point out we have nurses, but they tend to go off into other leadership roles. I want to hear what your vision is for the School of Nursing in terms of how you see the role of Yale’s specific school of nursing in helping develop the nursing community.‌

Azita Emami: First of all, thank you very much for inviting me. It’s a privilege to be here and share my thoughts and my perspective on various issues.‌

Your question is a very good question. Yale School of Nursing is committed to prepare nurses to become leaders. What you just shared about nurses eventually changing their career if they are interested in leadership or senior executive administrative role, we try to really prepare them to become leaders in the field of nursing science, nursing education, and nursing practice.‌

And I think that is very important because I think that we are the most trusted profession continuously across several decades. We don’t need to prove ourselves in terms of our clinical expertise, but I think that really adding the leadership acumen to the nursing profession is very important because then we will have a seat at the table of decision-making about policies, about healthcare systems, and so forth and so on.‌

And this is so important. It’s really closing the loop of our passion and commitment to care for people. So, that is what the School of Nursing has been about. I think that the school has been around for 100 years and that is what we are doing. We really prepare nurse leaders.‌

Harlan Krumholz: It’s so nice to meet you. You have such a great reputation around the Yale campus and the nursing school is really a jewel of the medical campus.‌

I was fascinated to learn a little bit just about your personal history. I wonder if you’d be willing to share it. I mean, you started in Iran and you go to Sweden. That’s an interesting path, and it must be very different in so many different ways. I mean, the weather was different, but also the culture, the language, and there’s so many things to do. You’re really a person of the world.‌

But can you just tell us a little bit about this journey of yours? Because it’s quite interesting.‌

Azita Emami: Sure. I didn’t leave my country by choice. We had to leave after the Islamic Revolution. And, as you all know, our beautiful, wonderful country is not a good place for anyone to actually live there. Especially I think that any family who have daughters, they really think twice about if they have the opportunity to stay in the country. So that was what we did. We left.‌

And the choice of moving to Sweden was not actually a choice because it was a very difficult time. It was chaos after the revolution and the people who wanted to just leave, they had to just take the best possible country and leave. And we ended up in Sweden, and that is where I started my education.‌

I was young, and I had just graduated from high school, so I started my higher education in Sweden and applied for an undergraduate nursing program at Karolinska. And the rest of it was on my résumé, my bio that Howie just shared, that I eventually went on and took a master’s degree in international health and then eventually a PhD in medical science. And then—‌

Harlan Krumholz: What was it like for you to make that journey? I mean, it is amazing for people to think about.‌

I mean, we talk a lot about immigrants and immigration. Here’s someone, you have to leave the country, and it’s not like you can survey, “Where do we want to go?” It’s “Where can we go?” And then you want to become a member of that society and contribute, and you’re off to college there. What was it like for you, exactly, at that time?‌

Azita Emami: I think that I actually reflect a lot on that nowadays, maybe because I just feel that there are flashbacks or déjà vu of experiences that I had in Iran that we are facing right now in the United States that really makes me to think about my emigration and immigration experiences.‌

I think that I have been very, very busy building my life, so I just did what was required to survive, but I never reflected on that. And this is the first time, I’m in my sixties and I really look back and I really try to reflect on how it was.‌

I think that perhaps it is a kind of post-traumatic experience, actually, because it is very stressful, especially for a young person uprooting from their background and ending up in a country where you don’t understand the language and you are supposed to make the most important decisions about your life, your education, and everything. And nothing can go wrong because you don’t have this support network that you had in your country. And very quickly, I made a career in Sweden and then United States.‌

But right now I’m just feeling that, how vulnerable you are as a young immigrant and how our students, our faculty, are now experiencing the situation in the United States when the threat of deportation or harassment and all kinds of different situations that they might face. So that really takes me back to my experiences.‌

Sweden at that time was a very homogeneous society. It’s not like what it is now. But at that point of time, we stood out with our skin color and hair color. And it was not easy because when you are in your home country, you belong to the society. But when you have to quickly readjust, these are the things that you never even pay attention to. That your skin color might be an issue in encountering with other people or they look at that, your appearance, rather than who you are.‌

Harlan Krumholz: And how did you decide about nursing at that time?‌

Azita Emami: It was a very interesting decision because since I was a child, I was always convinced that I wanted to study law. I wanted to become a judge.‌

But when I ended up in Sweden, there was a wonderful opportunity for young people like me to experience different career opportunities, to really go and shadow in different work settings. And one of them was in a hospital as a nurse.‌

Reluctantly, I did it, and I really fell in love with nursing. Actually, the reason that I wanted to pursue law was to help people. And I just realized that nursing is where you really feel this reward of constantly being with people where they need your care more than anything else. And immediately, I decided to pursue nursing. So I applied for the nursing program at Karolinska. And the rest of it, you know about it.‌

Harlan Krumholz: Of the eight Ivy League schools, seven of them have medical schools, but I think only three of them have schools of nursing: Penn, Columbia, and Yale. What’s the case for the importance of a school of nursing within a medical campus like ours? Why did Yale make, do you think—I assume you do—a good decision when they began a school of nursing? I mean, what’s the case for it? Because so many don’t have it.‌

Azita Emami: Yes, they don’t have it. And I think that it’s really a loss. Because I think that health sciences in an academic setting can really be cross-fertilizing for each other. I think that it’s very important.‌

I really believe in interprofessional education for all health sciences programs. I really believe that if we can prepare our students, no matter they are medical students, nursing students, public health students, if we really put them together and in a kind of interprofessional educational setting, they eventually learn to also teamwork when they are clinicians or in whatever settings that they choose to work.‌

And that is so important because I think that a lot of our problems in the healthcare services right now is because of the silos that are between different professions. And if we learn to respect each other to work with each other, I think that the outcome of our services will be much better.‌

So I really applaud Yale for making that decision, but I have to tell you that it was a very attractive decision, attractive proposition, that they perhaps didn’t want to turn down because it was for 100 years ago that the Rockefeller Foundation thought that nursing programs in the United States should become an academic program. Prior to that, nursing was a diploma degree in the United States.‌

So they reached out to one of the best universities in the country, Yale, and they asked, “If we give you $1 million, can you commit to establish an academic nursing program?” And of course, a million dollar a hundred years ago, of course no one turns that offer down. So that was the beginning of the establishment of Yale School of Nursing at Yale.‌

And I think that we have really succeeded to establish, develop, and constantly evolve and elaborate a fabulous nursing program. As I shared with you in the beginning, our focus is on leadership. And also, within that leadership framework, we are very committed to make sure that our students graduate with a mindset of health, justice, health equity, to really make sure that health is improved for all people, no matter where they come from, what skin color they have, and what socioeconomic situations they—‌

Harlan Krumholz: And just to say, how many students and how many faculty?‌

Azita Emami: So we have about 600, 650 students, all graduates, of course. We don’t have undergraduate program at Yale.‌

Harlan Krumholz: That means that they’re all nurses already when they come? Or they just have—‌

Azita Emami: Yes.‌

Harlan Krumholz: Yes.‌

Azita Emami: If you look at the history of Yale School of Nursing, there are a lot of pioneering, innovative initiatives that actually originated from Yale School of Nursing.‌

One of them was our GEPN program, which is a graduate program for students with a different degree, non-nursing degree, but a bachelor’s degree, and if they want to pursue a nursing career and obtain a master’s degree in nursing. So that is, you know, originally started at Yale School of Nursing; now you can see it in any school of nursing in the country.‌

But that really offers opportunity for people who might change their mind about their career choices and they want to become a nurse and they apply. And it’s an accelerated program, so it’s shorter than the ordinary traditional nursing program. And they graduate with a master’s of science in nursing and become usually nurse practitioners.‌

Howard Forman: I would be remiss to not highlight the fact that you remain a scholar as well. That even in these administrative roles, leadership roles, that you continue to be quite prolific with your research, collaborating with your colleagues at Karolinska as well as elsewhere.‌

And I wanted to ask, because this is similar to a question I posed two weeks ago when we had Dr. Steve Waxman on, how do you strike that balance? How do you decide where you’re going to put your energies when there’s so many good things that you’re doing? How do you make those decisions?‌

Azita Emami: I think that I really flourish and enjoy when I work with a team. And I think that the success for any project, any initiative, any choice that you make in your life is who are the people who are supporting you. If you have a very strong support system that you can rely on and also enjoy working with them, everything becomes easy and smooth.‌

And I think that the reason why I have not been able to abandon my research at Karolinska, it’s not only because I have a very strong passion for science and for research, but also because I have a team that I have not been able to be parted from. And they are really amazing and we work with each other and we just accomplish fabulous things without really making this effort as a burden for anyone.‌

And I think that that is true for even my administrative role at Yale School of Nursing now and my previous institutions, that I really try always to surround myself with very strong team workers and creating this trustful situation, that we rely on each other and we all work to support each other. And I think that that is a key for success. If you have that support network, you cannot fail.‌

Harlan Krumholz: We’re just getting to the end. I want to end with a question that was put up by one of our amazing undergrads, Gloria Beck. She pushed forward this question. “I thought the dean’s work with saliva collection for stress hormones was very interesting, and I’m wondering if this method has been used in more widespread clinical settings since your study was published?” So I wanted to just push that question forward.‌

Azita Emami: That’s a great question. Thank you very much. Yes.‌

For a long time, I have been focusing on nonpharmacological care interventions for people with dementia or cognitive impairment. And a lot of interventions proved to be useful, but we never actually had looked to see what are the kind of physiological impacts that these interventions might have on improving the care for these people.‌

And that was why I decided to use saliva, taking saliva to measure their cortisol while we were conducting a music intervention for people with dementia and their family caregivers. With that, we wanted to know whether the music intervention would lower their stress.‌

And we actually looked at two hormones. One was cortisol and the other one was DHEAS, which is another hormone that really could be an indicator for the level of your stress. And this was the first time it was done with that population because usually, with people with cognitive impairment, it’s very difficult to do any research that is so-called invasive because they can very easily become agitated.‌

So we started actually this study by only thinking whether or not collecting saliva would be possible, so it was a feasibility study that we started. It showed to be feasible if you really, again, have a good team that could actually help to create an environment where the people with cognitive impairment are not that agitated when we collected the saliva.‌

We didn’t have any dropout, which is really phenomenal. So our study was the first, very pioneering, study showing that it’s possible to collect saliva or physiological biomarkers in that particular population. And then it actually showed that, which is very interesting by secondary result that surprise all of us was that the cortisol level, the level of stress went down in the people with dementia—but not significantly. But in their family caregivers, the stress really reduced in a significant way.‌

And we think that the reason why the significant result outcome was not shown with people with dementia is because of the physiology of their diagnosis, their dementia. Because it’s a very progressive disease, and we decided to focus on people with moderate and severe dementia. And as you know, in the end of the disease cycle, it is even more aggressively progress. And we think that it really messes up the hormonal production in the body, and maybe if they didn’t have that health condition, they would also show significant results.‌

But now, the next study, we are going to focus on really looking at how this was so remarkable for the people who are caring for people with dementia.‌

Howard Forman: Well, it is a pleasure to have you on. And quite frankly, I mean you are a role model and a leader at Yale, and we are very lucky to have you. So thank you for joining us today.‌

Harlan Krumholz: Thank you so much.‌

Azita Emami: Thank you. Thank you very much for inviting me. It’s always a privilege to be able to share your thoughts and your experiences. Thank you.‌

Howard Forman: We appreciate you.‌

Harlan Krumholz: Thank you.‌

Azita Emami: Thank you. Bye.‌

Harlan Krumholz: Hey, that was a great interview, Howie. I’m so glad that—‌

Howard Forman: She’s very nice.‌

Harlan Krumholz: ... we had her on.‌

Howard Forman: Glad to have met her.‌

Harlan Krumholz: But now I’m interested in what you’ve got to say this week. So what’s going on in your mind?‌

Howard Forman: I have some just brief infectious disease updates, and most of this I see as good news. So I want to end on a good note today.‌

We haven’t talked about malaria in over a year, and while there’s an awful lot of bad news in the press lately, the global health community continues to make an awful lot of progress on the malaria front. And I thought we could close with some thoughts on this to top this part off.‌

A reminder for our listeners, malaria is caused by a parasite that is transmitted through the bite of a mosquito. If you can stop infected mosquitoes, you stop transmission. But in many parts of the world, this is easier said than done. So through a combination of mosquito nets, bug spray, other means of reducing mosquitoes, progress can be made, but you also have to diagnose people and treat them early to break the cycle.‌

Hundreds of millions of people are infected with malaria each year, and more than half a million die. So while the fatality rate may be lower than some other lethal diseases, the prevalence is so high that we’re still losing hundreds and hundreds of thousands of people every year, and it disproportionately kills children under the age of five.‌

None of this is the good news, but here it is. Here’s the good news. The country of Georgia, in January, was declared malaria-free by the World Health Organization, becoming the 45th country to be so declared. And last week, Suriname became the 46th country. These aren’t large countries—I actually had to look up the populations for each of them on the map to figure out even what the consequences are, but every bit helps in the effort to eradicate malaria and other infectious diseases. And the Global Fund to Fight AIDS, Tuberculosis, and Malaria is one of the many groups that have made this possible.‌

It takes more than a village here. The departure of USAID, which we have returned to time and time again over the last few months, from our healthcare landscape, is going to reduce these successes, but it will not stop them completely. We need to continue to invest in eradication efforts, and I’m glad to see this one come along and continue to progress.‌

Another malaria piece of good news is that Novartis in Switzerland got a drug approved to treat babies with malaria. This is the first approved drug in the world for babies. And as we mentioned, malaria disproportionately affects children under the age of five. The drug is called Coartem Baby, and Novartis is committed to distributing this on a mostly not-for-profit basis, according to the news report that I read.‌

And following up on that, as a brief follow-up to what you discussed last week on lenacapivir, which is the new amazing HIV prevention drug called Yetzugo, this drug, which is twice-yearly injections and has incredible efficacy, Gilead has now announced that they’ll provide this at cost through the same global fund that we just mentioned to 2 million people each year. So that’s another piece of good news.‌

And then, as much as I am continuing to be focused on global challenges, I also wanted to pick up on what I think is mixed news but mostly good news on the measles front. Because on the one hand, we’ve now officially exceeded the outbreak for 2019 in the United States for measles. So we now have the most cases since 1992, that’s 33 years ago. And we remain in danger of losing our measles eradication status. That’s obviously not the good news.‌

But on the other hand, there is no question that the outbreak is abating, and we have not seen more deaths. And the West Texas outbreak in particular is mostly over, even though it has caused other outbreaks throughout the other 38 states over time. But in the category of glass half full, I’m pleased to see us entering summer with fewer and fewer new cases. The fall and winter, we’ll likely see some more cases, but let’s at least for the moment, embrace something good right now.‌

Harlan Krumholz: Well, I like that, Howie, because I’m always ready to embrace something good, so—‌

Howard Forman: I know you are.‌

Harlan Krumholz: ... I appreciate you bringing that good news. Yeah, I mean, all this is going to be about surveillance and vigilance, and I think some of the concerns that we have have to do with our capacity to respond when things do go wrong, but it’s good to know that we’re—‌

Howard Forman: I mean, we’re come back to this again and again, Harlan. I’m not going to act like everything’s perfect, but it made me feel better. I just looked at the graph today again to remind myself how far we’ve come with this. And it would just be nice to think if we could tamp this down by the end of the year, that would be a huge success.‌

And to the credit of the local authorities in West Texas and elsewhere, they’ve done a great job at both diagnosing, isolating, and treating patients to the extent possible and preventing spread.‌

Harlan Krumholz: That’s great. Since you’re going to mention Texas, our hearts go out to everyone for the extreme weather events that caused the flash flooding and—‌

Howard Forman: They have faced horrible, horrible—‌

Harlan Krumholz: ... and all of that. And again, the massive health implications, not only for the loss of life, but there’s also these secondary issues that occur around these disasters. So anyway, we’re thinking of everyone out there, too.‌

Howard Forman: One of the worst.‌

Harlan Krumholz: Heartwrenching.‌

Howard Forman: I think it’s probably the worst non-coastal disaster in our nation’s history in terms of just deaths from a flood, or at least in the last hundred years.‌

Harlan Krumholz: It just again speaks to this need for us to be very proactive and anticipatory with regard to some of these risks because this could have been prevented. There were things, there were investments or ways that this could have been prevented. Meaning not just in the moment with the communications, but anticipating what’s worst-case scenario? How do we protect people?‌

And it’s just like we always say, if you make those investments, everyone’s always wondering, “Is it worth it?” because you never see who you save, and that’s why when things go bad, I think we have to at least linger for a minute to think like—‌

Howard Forman: And learn.‌

Harlan Krumholz: These are the things that you do avoid if you’re able to make smart investments to try to promote public health, safety, and so forth.‌

Howard Forman: Agreed.‌

Harlan Krumholz: You’ve been listening to Health & Veritas with Harlan Krumholz and Howie Forman.‌

Howard Forman: So how did we do? To give us your feedback or to keep the conversation going, email us at health.veritas@yale.edu or follow us on any of social media.‌

Harlan Krumholz: And we love to hear your feedback, your questions. Tell us about your experience with these topics. If you like the podcast, rate us, review us on your favorite podcast app. We always read the reviews.‌

Howard Forman: And we really do. We really appreciate the feedback that we do get.‌

Harlan Krumholz: Yeah, it helps people find us.‌

Howard Forman: And if you have questions about the MBA for Executives program at the Yale School of Management, reach out via email for more information or check out our website at som.yale.edu/emba.‌

Harlan Krumholz: Health & Veritas is produced with the Yale School of Management, Yale School of Public Health. Thanks to our amazing, spectacular, unbelievable researchers, our undergrads, Tobias Liu and Gloria Beck, and to our marvelous, remarkable producer, Miranda Shafer, and to the best partner in the world, Howie Forman.‌

Howard Forman: Thanks very much, Harlan. It’s great to be with you again.‌

Harlan Krumholz: Yeah, I’ll talk to you soon, Howie.‌

Howard Forman: Thanks. Talk to you soon, Harlan.‌