Because the coronavirus 2019 (COVID-19) pandemic has affected all aspects of health care, including clinical trials activities, this article focuses on Michael Bowdish, MD, MS, FACS, a cardiothoracic surgeon-scientist at the University of Southern California (USC), Los Angeles, who is internationally recognized for his National Institutes of Health (NIH)-funded clinical trials work in cardiothoracic surgery. In the early stages of the public health crisis, Dr. Bowdish quickly redirected his research efforts toward critically ill COVID-19 patients.
Dr. Bowdish is an associate professor of surgery and preventive medicine (clinical scholar), division of cardiac surgery, USC, with clinical expertise in acquired heart disease and specific clinical expertise in aortic surgery and end-stage heart disease, practicing at both Keck Hospital and Los Angeles County-USC Medical Center (LAC-USC). Dr. Bowdish also has served in numerous leadership positions, including his current role as chair, USC biomedical institutional review board.
Dr. Bowdish completed his undergraduate degree at the University of Illinois, Urbana, followed by medical school at Washington University (Wash U), St. Louis, MO. He completed his general surgery residency at USC, followed by training in cardiothoracic surgery at New York Presbyterian-Columbia University Medical Center, NY. Dr. Bowdish completed a master of science in applied biostatistics and epidemiology at USC in 2019.
Dr. Bowdish was interviewed by Dr. Emamaullee in October 2020.
Explain your interest in becoming a physician.
I grew up in a little town of approximately 5,000 in northern Illinois. My parents still live there in the same house. My mother was an elementary music teacher, and she was a stay-at-home mom until my sister and I were adolescents. My father ran a family business that did high-precision machine work primarily for the aerospace industry. Although my parents did not have advanced degrees, they always emphasized the value of a college education.
I became interested in medicine starting around eighth grade. My maternal grandmother developed leukemia, and I was with her when she died. The whole process was very influential in my life. A general practitioner in my town, Francis J. Quincannon, MD, had a very broad practice. “Quin” was one of the best diagnosticians I have ever met and had the bedside manner of your best friend. Everyone loved him, and to this day I do not know anyone more dedicated to the field of medicine and humanity.
As a freshman in high school, I asked him if I could work in his office, and he took me on as a 15-year-old kid to work in his office over the summer. I cleaned exam rooms, filed charts, and did whatever they asked me to do for $3.25 an hour. It was a different age, and I saw a lot of patients. He would do house calls, so I would go with him in his truck out to the farmhouses and see patients. He did everything from deliver babies to surgical procedures, including cholecystectomies, hernias, and mastectomies, with another physician who would come in from a bigger town to assist him. The whole experience really solidified my interest in medicine. I still remember patients I took care of with him, especially those who were bedbound in the little farmhouses. To this day, when I return home, I will see patients whom Quin took care of who ask why I didn’t come back to be their doctor.
How did you choose surgery?
Well, it was my experience with Dr. Quincannon. Like I said, it was a different age, and he allowed me to observe in the operating room (OR) at our small, 10-bed, community hospital. He would post a case at 6:30 am, be done by 9:00 am, and then be in the office the rest of the day. I also became involved in what we called a rescue squad. We functioned as a volunteer ambulance service, but it involved more than just taking people to the hospital. We were pulling people out of cars, farm accidents, out of culverts, you name it.
When I got to medical school in St. Louis, I met a couple of real surgeons, beginning in the anatomy lab. A surgeon named Ernesto Molmenti, MD, FACS, would actively try to get medical students interested in surgery. He came over and said, “Michael, come join me for my next call shift.” So, I was in my second week of medical school, shadowing Ernesto on the trauma service on a Friday night. I shadowed him a lot, and I decided that I wanted to become a trauma surgeon.
At Wash U, I had some really great mentors in trauma and critical care. Perren Cobb, MD, FACS, was the attending at the time, and his boss was Timothy Buchman, MD, PhD, FACS. I still view both of them as my top mentors from medical school. They both advised me that broadening my training experience at a high-volume trauma center would expand my skill set as a surgeon. I came to USC for my general surgeon training because of the outstanding training environment at LAC-USC.
How did you change your trajectory toward cardiothoracic surgery?
When you come out of medical school, you may have one set of goals, but whom you meet along the way can really influence your interests. As a general surgery resident, I was on the cardiac surgery service at USC. I didn’t meet our current chair, Vaughn Starnes, MD, FACS, initially, but I worked closely with Mark Barr, MD, who was very involved in caring for the cardiac surgery patients. He and I would round twice a day on all the patients, and at the end of the rotation, he invited me to work in his research lab.
Ultimately, my experience on that cardiac surgery rotation changed my path. I had really enjoyed the clinical challenges and patient population, and I encountered a group of physicians who were very invested in my potential.
A lot of surgical residents have research sabbaticals but don’t end up as clinician-scientists. When and how did you decide to fold research into your clinical practice?
You know, early on I recognized that I wanted to be a clinician-scientist. As a student, you really don’t know what that means, but I always told people that one of my goals was to be a strong clinician with federal funding. I acknowledged that it can exist in many different ways. If you asked me 20 years ago what I envisioned, I would have described something more like what you are doing, with your own basic science lab. I think back to my time at Wash U and consider Dr. Buchman to be the epitome of the surgeon-scientist. He was a superstar with a huge research lab, was clinically busy, and he always seemed to be in four places at once. Originally, I really wanted to be like him when I came out of training.
You have become an expert clinical trialist. How did you gain experience with federally funded clinical trials?
After my fellowship, I was at the University of North Carolina at Chapel Hill (UNC) for two years. I tried to participate in an NIH-funded clinical trial there as an ancillary site in a study looking at early versus old blood in blood transfusions during cardiac surgery. It took me the better part of two years to even get institutional review board (IRB) approval because I tried to do everything myself and didn’t have enough experience under my belt.
When I came to USC, I became involved with the Cardiothoracic Surgical Trials Network (CTSN) funded by the National Heart, Lung, and Blood Institute (NHLBI). They were having issues with enrollment in their first trials and had issued a request for applications for sites to join two existing studies related to mitral regurgitation.
When I joined the faculty at USC, we had already been accepted as a study site. In my first few months, Dr. Starnes approached me and asked me to take on the role as site principal investigator (PI). I went to the investigator meeting, and that was my introduction to the CTSN.
Can you explain the origin of the CTSN?
The CTSN was designed to create a multi-institutional network of cardiothoracic surgery trial sites and was formed around 2007. The CTSN has proven to be a very productive, collaborative group of CT surgeons. USC became involved in 2010 as an ancillary study site and received direct federal funding as a primary core site in 2012. We offer broad expertise in cardiac surgery as well as a diverse patient population, particularly our patients at LAC-USC. I’m proud to say that of the patients we have enrolled in CTSN trials, more than half have been women and minorities.
What was the original plan for the most recent cycle of CTSN funding, before the COVID-19 pandemic began?
At each generation of the grant, they have changed the structure of the network. This time, they wanted us to increase our reach into areas of the country that are underserved and underrepresented. The CTSN comprised primarily East Coast sites, and we were the lone wolf on the West Coast. They specifically wanted us to partner with a linked site in an area with high disease burden. Ultimately, we partnered with St. Luke’s Medical Center in Kansas City, MO, which has a fairly large African-American population, as well as a high incidence of cardiovascular disease. There are five linked sites in all.
What was the original focus of the trials you were supposed to roll out in 2020?
We started a trial for postoperative atrial fibrillation after isolated coronary arterial bypass graft surgery. We also had a plan to roll out a stem cell trial in patients with heart failure.
How did things change when the COVID-19 pandemic began?
At first, the whole trial network came to a grinding halt like the rest of life. Many of us reached out, expressing the desire to do something. The beauty of the CTSN is that we are directly connected to NHLBI leadership. I sent an e-mail to one of the directors, as did a number of other CTSN investigators. We asked how to leverage the network to do something about the pandemic. It turned out that one of our industry partners had done a previous stem cell trial with a cell line in an early-phase acute lung injury trial in Europe. A single center also had data using these cells early on in the COVID-19 outbreak in New York, NY.
Right as the world came to a halt on March 15, we had a steering committee call, and the group unanimously agreed that we should do something. We quickly realized that we had a potential public partner who already had a trial idea in development that was on its way to the Food and Drug Administration (FDA). We got involved and rapidly revised that protocol to apply to patients with COVID-19 with acute lung injury. When the company went to the FDA and received the appropriate regulatory approvals, we were ready. Our first patient was enrolled within five weeks of that initial call.
Yes, we wrote about the “nuts and bolts” of preparing for COVID-19 clinical trials in the Journal of Surgical Research.*
The way the CTSN group and each clinical site came together was pretty amazing because we accelerated the trial time line dramatically to make this happen. Typically, it can take years to go from a primordial idea to actual patient enrollment. To go from an idea to enrollment in five weeks is almost unheard of. While we can debate if anything good really comes out of a pandemic, it has taken my abilities as a clinical researcher to a new level, and it hasn’t even involved cardiac surgery.
These are not surgical patients. Conducting these COVID-19 trials required building networks with other specialists whom I did not typically work with. We were able to partner with our medical and surgical critical care colleagues. We also had to completely restructure the way we perform clinical research at all levels of the institution. It has been pretty amazing to see everyone come together and work toward a common goal in the face of significant adversity.
Why have you taken on the challenges of conducting COVID-19 clinical trials?
I have asked myself that question a lot, and I have come to the conclusion that it goes back to why I wanted to be a doctor. At my core, I want to help people. I hope to God that there is nothing as terrible as this pandemic over the rest of my career.
For myself, I know that I have done something to try to help combat this horrible disease. It’s hard, though. It’s a tough population. The families are devastated. Many of them have had other family members who have died, and of course these are really sick patients. They’re so sick, getting sicker, and many will tell you, “Oh yeah, my mother, father, grandmother, son, uncle died as well.” It’s a lot to process emotionally.
I was going to ask what it’s like dealing with such tough outcomes in the clinical research setting, especially as you interact with the families of patients.
It’s really tough, and thankfully, I have been supported by an amazing research team. No great clinician-scientist succeeds alone. This trial has succeeded because of the people I have been working with throughout the hospital and the expertise and personnel in our departmental surgical research unit run by Linda Sher, MD, FACS. All of them have been amazing and extraordinarily dedicated. There have been low points. For some patients, they seem okay, and the next morning you come by and they are in body bags. It’s devastating.
What do you think people don’t understand about COVID-19 research?
I don’t think people can fathom all the challenges of conducting research in infected patients during a pandemic. Overall, we have enrolled more than 60 critically ill inpatients in COVID-19 therapeutic trials. It has been a tremendous amount of work. Doing research during a global pandemic has brought about some changes that will affect research moving forward. As chair of the USC biomedical IRB, I am involved in institutional research leadership. Things we have been trying to do for years literally got done overnight, such as remote signing of consents, remote signing of the Health Insurance Portability and Accountability Act waivers, and remote access to electronic health records.
Beyond that, I think it is really tough to get consent from the COVID-19 population. You need to think creatively because you have to talk to the patient and appropriately educate, inform, and so on. And then, of course, at some point as the PI, you will directly interact with the patients. For the research coordinators, involvement in COVID-19 trials is voluntary. None of them has direct patient contact, but physicians and nurses are doing it all the time.
There are risks involved in drawing samples and giving medications. I can’t even tell you how bad I would feel if one of our research staff were to get infected through study-related exposure. All of us recognize that risk and are willing to accept it. I go home, throw my clothes in the washer, and take a shower. I don’t want to bring it home to my wife and son.
You have had some family members affected by COVID-19, right?
Both my mother-in-law and my father-in-law died in April. We know that my father-in-law had COVID-19, but my mother-in-law wouldn’t allow them to test her. Given how close they were, I’m sure she had it as well. They died within two days of each other. We were unable to travel back to the East Coast. It was a difficult time.
It is pretty remarkable that you were setting up these COVID-19 trials while mourning their loss.
Yes, the CTSN stem cell trial was activated right around that time. In parallel, Operation Warp Speed from the federal government was established to develop private-public partnerships to develop therapies and preventative measures for COVID-19. They reached out to the National Institute of Allergy and Infectious Diseases and its Director, Anthony Fauci, MD, about potential trial sites.
If I go back to our original call with the NIH back in the middle of March, when we said that we needed to offer our trial platform for COVID-19, on the other side, the federal government was working toward leveraging existing federal trial platforms. They reached out to the NHLBI to connect with the CTSN because of our ongoing work with the stem cell trial. So, ultimately a group of heart surgeons was asked to run trials for inpatients with COVID-19.
The drive and commitment you have demonstrated in transitioning to COVID trials is inspiring. As a surgical researcher, how do you find work-life balance?
I have had moments in my life when I have been better at it than others. Between 2014 and 2017, I did eight Half Ironman triathlons. Since 2017, I have been busy clinically and doing research and also accepted more professional responsibilities. In so doing, it has become harder to find balance. There has been a recent shift in medical and surgical training, with more emphasis on balance and wellness. I am not sure that this movement extended enough into the faculty ranks. One of the challenges facing clinician-scientists is that many of our clinical colleagues do not fully understand what is involved in our daily workflow. Every day, I am either in the OR or doing something research- or administration-related, and I have not had much free time.
For trainees who are coming out right now, what is the biggest challenge to becoming a successful surgeon-scientist?
First, you have to be willing to make sacrifices. As my focus has changed throughout my career, I often have asked myself what I am really trying to do. You need to be adaptable. You need be a good surgeon, and you must be able to operate. The successful surgeon-scientists can still hold their own in the OR. Then you have to have good scientific focus. Lastly, you need mentorship and support from the top down.
I think you have to have that internal stubbornness. If you don’t have that drive and that passion to answer the question or just to figure it out, then it is easy to just let everything else take priority.
I’ll go back to my triathlon experience. If somebody told me 15 years ago that I was going to do a half Ironman, I would have said, “What is that? You are crazy.” I’ve read several motivational books, and many focus on mental toughness. You have to want it and also want to do it well. You must make priorities and stick to them. We need surgeon-scientists. We need people who are willing to ask difficult questions and try to get answers for these difficult questions to move the field forward. But you have to remember that it is not a sprint; it is a marathon. In fact, it’s more than a marathon. It is your whole life.
I know trainees do not get much exposure to clinical trials as a mechanism of research, even though it entails the forward-facing part of clinical medicine that we all rely on. I feel like I did not truly understand trials—the logistics of designing and submitting a trial to the NIH—until I became an attending surgeon.
I think many clinicians do not fully grasp the process. There are still aspects I do not fully understand because other personnel in our research group handle it, thankfully. In the academic world, sometimes those of us who do not do basic science work may not receive the same recognition. I have found it very rewarding to conduct federally funded clinical and translational research because it is directly applicable to the care that we provide to patients. In general, I am not trying to bring a product to market. I am more interested in the answer to the scientific, clinical question.
You are motivated by the possibility of directing patient care in a meaningful way.
Exactly. As a clinical trialist, I want to do studies that are going to have a meaningful impact and answer tough questions. For these trials, we perform the data analysis and write the paper, and as a group of scientific investigators, we have complete control over it.
What do you think is the role of mentorship?
Mentorship is critical. If anything, I wish I had more time to focus on it. I have had a variety of excellent mentors who have helped me with different aspects of my career. Every good mentorship relationship I’ve had has developed organically, rather than being assigned ahead of time.
My partners give me a hard time because I’m always at the hospital. Well, that’s how I get things done. I think my drive comes from my upbringing. I was taught that hard work pays off.
As surgeons, we may not always remember the patients who sail through their procedures. We often remember the ones where things went wrong and think about what we could have done differently. As a surgeon-scientist, these are the scenarios that drive my research.
Here is something interesting: the COVID-19 pandemic has actually made me less nervous about taking on difficult surgical cases. With all the challenges of the pandemic, when I am in the OR, I am in my element. Nothing happens in there that I cannot deal with, so it has actually been very relaxing to operate. I would be planning a tough redo aortic root case and feel like it was enjoyable and relaxing. My phone would be over there on silent and I would just be there doing what I needed to do, which is operating and saving somebody’s life. I have found the OR to be my safe place because it has allowed for a temporary reprieve from all the stress and worry. I have never felt that way in the past, and my mentor, Craig Smith, MD, FACS, mentioned something similar in one of his daily COVID-19 e-mails at the height of the New York outbreak.
How has your family felt about you doing all this—working hard and being on the front line? Do you have any regrets?
Back in early March, we all knew about COVID, but we did not really have a sense of what was coming. I remember picking my son up from school around March 12. I picked up his bag, and it was about 8 lbs. I asked him why his backpack was so heavy, and he told me that they told the kids to take their textbooks home. The school board voted to close the schools that night. We have close ties in New York, and I immediately got in touch with Dr. Smith. It was clear to me by that weekend that bad things were happening. Initially, I really wanted to fly out and support my physician friends back in New York. I held off for a few reasons. I knew things could get bad here, and in my other leadership and administrative roles, I knew I was needed.
On a deeper level, the main reason I stayed back was my family. I have a wife and son at home. I decided it wasn’t fair to them. They have been incredibly supportive, but it’s definitely been a challenge. I think one of the hardest things is that my wife wants to get out and do things, and because I have seen virtually every single intubated COVID patient at LAC-USC since the middle of April, I am hesitant. I see all these people out and about, and I think, “You know, I don’t think I’m going to go to the beach.”
I don’t know if my son really understands what I’ve been doing. I think he does to some degree, but you know, I’m kind of quiet at home about what I am doing. I don’t want to scare them. I couldn’t do anything that I do without my family. They are definitely the cement that keeps me grounded. Maybe someday my son or grandchildren will read this and understand what his dad did during the COVID pandemic.
*Emamaullee J, Bowdish M, Yan PY, Rodina V, Sher LS. Rapid adaptation of a surgical research unit to conduct clinical trials during the COVID-19 pandemic. J Surg Res. 2020 Dec;256:76-82. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323687/. Accessed January 13, 2021.