Transcript:
Dr Robert Kirsner:
I am thrilled today to have as a guest John Lantis, who is the site chief and professor of surgery at Mount Sinai West Hospital and the Icahn School of Medicine.
John is a vascular surgeon. He was named the director of advanced wound care in the Department of Surgery for the Mount Sinai Health Care System. He is well known to the wound healing community as the editor-in-chief of the journal Wounds. He is also well known in the vascular surgery community, as he was past president of the New York State Vascular Surgery Society and is a founding member of the American Board of Wound Medicine and Surgery and the Vascular Study Group of New York.
So, John, thank you so much for being here today. I'm looking forward to a great conversation.
Dr John Lantis:
Always great to see you, Robert, and I'm looking forward to this as well.
Dr Robert Kirsner:
Great. So, John, everybody knows you're a fantastic, astute, and sought-after clinician. But what I want to focus on a little bit today is your experience, your reputation, your acumen, and your insight as a clinical researcher. And to our audience, John has become one of the premier clinical researchers in all of wound care. And I'm very excited about this opportunity to have this conversation.
So, John, just as a little backstory, how did you get interested, or how did you kind of evolve your clinical career into one that encompassed research?
Dr John Lantis:
Yeah, this is always a fun story.
You know, I had started using this black foam that you attach to a suction device in 1998 in Boston. In my training, I was interested in this, and I brought it from one hospital to another. Many of you probably know this as negative pressure wound therapy. So I was interested in that, but that was not my first exposure.
I have to give a lot of credit to Dr Michael Conte, who is the chief of vascular surgery at UCSF in San Francisco and was my mentor in many ways in clinical care as well at Brigham and Women's Hospital.
So he and I got involved in a prospective randomized control trial, which actually had to do with neointimal hyperplasia after distal bypass. And I started really understanding a prospective randomized control trial as a fellow in 1999.
I finished up that trial and moved it to Columbia University, where I moved in 2000 or 2001. We finished up that trial, and I started to get an idea that I liked doing clinical research more than I had previously.
At that point in time, that trial kind of finished up in 2001 or 2002. And in 2001 or 2002, as you may remember, for those of you who were around doing clinical care, negative pressure wound therapy was not accepted by everybody. And I had experience in this. So I got involved in actually four negative pressure wound therapy trials.
And the story I always tell is I did not have a clinical research coordinator. So at Columbia University, an Ivy League school, I submitted all the IRB stuff. I was doing 600 cases a year as a young vascular surgeon. I submitted all the IRB stuff. And then, back then, KCI came to me and they said, “John, we'd like you to do these trials.” And I was like, “Great.” And they're like, “We're going to have these meetings.” I'm like, “Great.” And they're like, “And we want your clinical trial coordinator to come with you.” And I'm like, “Great.”
So I took my senior partner's secretary to all these trials. Her husband was a World War II vet. And I remember, at one point, we were at a meeting in Phoenix, Arizona, maybe Scottsdale, not sure, and they said, “Where's your clinical trial coordinator? They're meant to be here.” And I'm like, “Well…”
She was probably 65 or 70, with her 90-year-old husband out at the pool. And I said, “Well, they're at the pool. I've got it.”
So the first three years was smoke and mirrors, quite frankly. And then we got everything going and got it going right and everything. But there was definitely a little bit of spit and paper towels to keep things going for the first three years of clinical research. But since then, we've managed to build a full, appropriate—
Looking back, I would have never allowed myself to be in a trial like that, but we did okay.
Dr Robert Kirsner:
Wow. So that's quite a story. And so one of the first messages to any young person who's thinking about starting to get involved in clinical research is that infrastructure is critically important, and they should learn from your experience. Having the right infrastructure is probably mission-critical.
Dr John Lantis:
Helps a lot. It helps a lot to have a mentor. I mean, the reality is—
And I knew this going to Columbia. It sounds funny. You think Ivy League school, you go there. And I actually knew this, not even talking about Ivy League specifically, but I knew from going to Columbia after leaving Harvard. I actually knew what the issues were.
But I would say, for a young investigator, you can either decide you're going to go somewhere and develop something and understand what you need to develop, or, like someone joining you in dermatology, Robin, if they came to you, they can get into clinical research very quickly because you have an infrastructure.
So I think there are differences in if you want to do it and you're going out, know if you have support or not. So mentorship and infrastructure are critical.
Dr Robert Kirsner:
So, John, you talked about the kind of classic high-level evidence, a randomized placebo-controlled or some type of controlled clinical trial. But over the years, you've also had a tremendous amount of experience in helping young companies kind of get their feet wet with experience with their products, trying them kind of in a real-world situation. How did you get involved? How did you make that transition to include kind of real-world experience and investigation as part of your clinical research program?
Dr John Lantis:
Well, I think, as you well know, Robert, and I think Carolyn Fife may be the prodigal daughter of this, out running around talking about it, so many of the patients that we treat don't match trials, right?
So I've always been interested in the folks who don't meet the trial criteria and how many patients. And as a person who becomes involved in the trial business, if you will, you realize that probably only 8% to 12% of your patients meet trial criteria. So what happens with all those other patients who don't meet those trial criteria?
So I've given a fair amount of guidance to everything from registries. Now, I would say there's a weakness of registries, where you have a bias that you may only include patients who do well in a registry. Also, registry follow-up is not as rigorous as a prospective randomized controlled trial.
So I think the real-world trial information is interesting, and you and I have both been involved in this, where one of the problems that you see is maybe a patient gets a piece of X or a piece of Y or a treatment Z once, and then they get into this prospective therapy.
So I don't think we still have an ideal way of doing this. That's the issue. And that's, quite frankly, again, my primary world is vascular surgery, but somebody taught me how to do a carotid endarterectomy, and I know how to do it. But how to heal a diabetic foot ulcer is much harder in many ways. That sounds bizarre, and that's why I'm interested in wound closure, wound healing.
And I think this is true of trials. Trials for wound closure have so many issues that they have to deal with. And how do we deal with that? I think I will retire without knowing that for sure. But I think I have an interest in decentralized trials, which allow more patients to have more data about how they really function. Maybe they don't know whether they're offloading all the time, and maybe we shouldn't treat them with X, but we don't know that for sure yet.
So I think there's a lot of growth yet to happen, and technology is going to help us.
Dr Robert Kirsner:
Yeah, so you mentioned decentralized trials. For the audience, if you're not familiar with it, traditionally people would come to a famous center like John's and get seen in his clinic and get all the evaluations there. But to make trials a little bit more accessible to patients, especially those with fewer resources, there's this idea of bringing the trial site to the patient, where investigators or researchers go to somebody's home, for example, and do the study procedure there. And that would hopefully make it more generalizable with regard to the results because it's more of a real-world population.
John, so you're involved, heavily involved, with clinical research. What do you think is the, if you had to pick one or two or three of the most important kind of gaps that we have right now in wound care clinical trials?
Dr John Lantis:
Yeah, great question, Robert. Thanks so much.
I mean, I think the issue is synergistic therapy, right? Like you and your team often use synergistic therapy. And you may use immunotherapy in combination with a topical agent for pyoderma or for hidradenitis suppurativa. You may use, again, an immunologic. And right now, our ability in wound care is limited.
And we should be really trying to augment what we know from cancer trials, I think. I mean, nobody ever said 5-FU is the best treatment for colon cancer. But 5-FU with a rescue therapy might be. And I think, unfortunately, we're still stuck with the industry-driven modulation, like, “I do this with this.”
Recently in pyoderma, we've had very good success with a specific therapy. I'm not going to get into what that is, but a specific therapy in combination with immunomodulation. And we need to do a better job.
So number one is looking at algorithms of care.
Number two is looking outside. And I think everybody who lives in this world and lives outside this world probably gets this: the simple diabetic foot ulcer is an incredibly reproducible entity that we can study therapies in. You could argue that none of us need any therapy. We could just cast people and they do well. And that's always the bugaboo.
I think secondarily, it is looking at synergistic therapy or algorithm of care, synergistic therapy in problem wounds, and then looking at the wounds that are poorly defined, which you can either argue are 20% to 25% of the other wounds or 50% if you include postsurgical wounds.
So we don't do enough clinical research in patients who have these atypical or other wounds. We're sort of stuck with venous leg ulcer, diabetic foot ulcer, pressure ulcer, deep, not deep. We sort of have our sights on 50% of what we actually deal with. And so I think we need to expand our armamentarium to patients outside our comfort zone.
Dr Robert Kirsner:
So thank you, John. That was very insightful. I think the audience really appreciates that kind of great systematic thinking.
You mentioned in the beginning about the importance of a mentor. You mentioned Mike Conte and how he influenced your kind of career and got you kind of on the right track with regard to research. If you were going—if you probably mentor a lot of people, I know that—what are the key messages you tell them to be a successful clinical researcher? Is there kind of a checklist or top couple that you might impart to them?
Dr John Lantis:
Yeah, I think number one is, if you want to study something, study something you have a problem with, like you personally have a problem with.
I can't fix Mrs Steinmetz. I can't. Mrs Steinmetz has this problem. I think this is the problem. I can't fix this. How do I do a study to fix this problem?
And I think that makes it much more clinically relevant to the human, to the oath you've taken to heal people, and makes it more interesting to you.
I try to steer people away from, “This seems like there are 30 patients who need this. I'm going to do this.” And like, well, aren't there 14 other answers to this problem already?
And I know you live in this world as well, Robert. I mean, you've been around for a year or two now. But all kidding aside, I really think that you want to study problems you personally have, right?
And I think I see this, and I'm sure you do too, when you review large studies or other things, you can tell folks who are studying a problem they have versus studying a problem that occurs and there's revenue to be derived here, et cetera.
So I think really figuring out what you're dealing with and how you want to approach this and thinking about, “Is this a study I would design myself?” Someone brought it to me. They showed it to me. But does this make sense? Is this something I should do? What's the follow-up period? Is the follow-up period only 12 weeks? Well, I see these patients forever. Or is the follow-up, you know, “Thank God they're done at 12 weeks. I don't have to see them again.”
So again, I recommend that people actually study problems they see and that they need a solution to.
Dr Robert Kirsner:
So you do, obviously, a bunch of things, including research, as we talked about, and also clinical care. How does your typical week look? How do you divide that time? And do you think the diversity of activities that you do kind of brings additional joy, happiness, or satisfaction to your professional life?
Dr John Lantis:
It's a fantastic question. I remember a very, very long time ago walking across my undergraduate campus with a woman I'm now married to, and I said, “This is what I want to do. I can do anything until I'm 40.” Of course, at the time, I'm 21 or 22. I said, “I can do anything until I'm 40, but I'll get bored. So I want to do something I'm interested in. So when I'm 60, 65, 70, I want something more interesting.”
Oddly, she put up with it and is still married to me.
But to your point, my general week—I have tried to separate clinical research from clinical care, and that just became blindingly hard to do, and patients move in and out.
So I fundamentally see patients two times a week. I see about 120 patients a week. I oversee a fellows clinic on Wednesdays, which is the day we're recording this. But this is an academic day. But that did not start—I did not have an academic day when I was an assistant or associate professor. But as a full professor, I have an academic day. And then I operate two days a week. So yesterday I did five cases.
So I have two days a week that I operate, two days a week that I see patients, which is fully integrated with my two CRCs seeing patients, my wound surgery and medicine fellow seeing patients, two surgical residents, and myself.
So that's two days a week. Then I have two days a week in the OR. So it's four clinical days, one academic day. And then the weekends I just take off. I sit back. I relax. I put my feet up.
Well, maybe not. But that's how my week works.
Dr Robert Kirsner:
Well, that sounds like a pretty full week. You're certainly doing a great job.
And was there a turning point where, as you were kind of growing your career, that you said to yourself, “Well, I really got this”? Or is it every day, you know, you're saying, “I hope to get this someday”?
Dr John Lantis:
You ask the best questions.
There are a couple of interesting issues. I'm in a situation where I'm an academic vascular surgeon in Manhattan, which is an aggressive environment. We have more specialists in New York—I think we beat Miami and Chicago and L.A.
We did go through a situation where I had a very stable research environment and I was incredibly productive at a certain point in my career, which is probably about 12 years ago. And it was like a golden point, like everything was working.
And at that point in time, our hospital system got bought by a bigger hospital system, and the academic research module changed. At that point in time, for about 12 to 18 months, I actually completely shut down academic research because everything had been just blown up—how it worked, how the economy of it worked, the nursing staff, how my staff worked. My staff left, et cetera.
It was probably life-changing in that I looked at the whole thing and I just went deep into clinical medicine. Fine, busy clinical practice. And I was like, “I miss this. I miss doing this. This is interesting. This sustains me outside of just day to day.”
And I went back and we reinvented. There was an enterprise that existed within surgery, but I accepted it. I accepted the change. I accepted the model that we had to change to. And I did that. And definitely it provides me a sustenance that sometimes other stuff doesn't.
So if you just said it's like a well-balanced meal—I get some protein, I get some carbohydrates, I get appropriate vitamins and minerals, I get my appropriate fats—this allows a third portion, because my portions were really clinical care, outcomes, revenue, no research. And so this third portion allows me to explore new things. Sometimes they sound crazy, but it's fun, and it remains fun 25 or 30 years later. I definitely feel more fulfilled by doing the research portion.
Dr Robert Kirsner:
Well, you certainly have made a huge impact outside your own clinic walls. Your patients are blessed to have you as their doctor, but the impact you've made through directing companies or helping them make their products better for patients, and also studying products and helping them bring them to market, has been tremendously impactful.
This podcast series is a lot about people, and I'm going to put you on the spot as we kind of conclude and ask you a tough question. So get prepared. If John Lantis had a Mount Rushmore of either people in his life or in his professional career, who would you put on your Mount Rushmore for wound healing?
Dr John Lantis:
Well, I think for the whole research, how to approach this enterprise, I would put first and foremost—emotional almost—Steve Schwaitzberg, who's the chair of surgery at the University at Buffalo. He was my mentor in general surgery, and I truly love the guy. He taught me so much about how to work with industry.
You set yourself up for this one.
Number two would be Mike Conte. He really taught me a lot about how to do clinical research and how to be a good scientist.
I think Mount Rushmore has a certain number of people. The reality of this is, you belong up there.
Dr Robert Kirsner:
Well, thank you. Thank you.
Dr John Lantis:
Yeah. I think you have taught me much, much about how to deal with companies, how to make people feel good, how to—sometimes, in all humor, be like, “Well, your product's sort of interesting.” I'm like, well, that's a euphemism.
I have sat in so many meetings with you and been so impressed.
And then I would throw out there a fourth, who is not a research guy but a mentor, and he's the person who hired me at Columbia, is George Todd, who's a vascular surgeon. But he has taught me a lot about how to deal with people who have problems and how to look at their problem and assess them as a clinician.
But in all fairness to you, you have been an incredible mentor.
Dr Robert Kirsner:
Well, I don't think there's a better place to end than on that. No, just kidding, John. But John, I want to thank you so much for your time and for joining us. This has been tremendous.
I want to thank you again, on behalf of the entire wound care community, for all that you do. And the good news is that while you have experience, you also have many more years until you get to those magic numbers you mentioned. So we'll look forward to your continuing contributions.
Thank you so much for being on the podcast. Really great to have you.
Dr John Lantis:
Thank you so much for having me. Absolutely wonderful talking to you always, Robert. I really appreciate it.