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Prostate Cancer Research Gala Celebrates Innovations in Research and Patient Care at Mount Sinai

Updated on Mar 16, 2023 | Community, Featured, Your Health

Frorm left: Dennis Charney, MD, Ash Tewari, MBBS, MCh, and Robert F. Smith

The Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mount Sinai hosted its annual Prostate Cancer Research Gala on Tuesday, March 7, at the Rainbow Room at Rockefeller Center.

Ash Tewari, MBBS, MCh, Chair of the Department of Urology at the Mount Sinai Health System and the Kyung Hyun Kim, MD Professor of Urology at Icahn Mount Sinai, started the gala with the goal of raising money for the Center of Excellence for Prostate Cancer within the Department of Urology. Its mission is to eliminate prostate cancer through programs that integrate patient care, research and prevention, and education for students, trainees, professionals, and the public.

With nearly 200 people in attendance and more than $1 million raised, the event was a success by any measure.

The first honoree to be recognized was Burton Wallack, a three-time cancer survivor who received the Patient of Courage Award.

Burton Wallack, left, and Robert F. Smith

“Go to the end…and you can still win. And that’s the story of Burt Wallack,” said Dr. Tewari in a video shown at the event. Mr. Wallack, the founder and Chairman of Wallack Management Company, also serves on the Chairman’s Urology Board, partnering with his doctor to advance research.

Dennis Charney, MD, Anne and Joel Ehrenkranz Dean of Icahn Mount Sinai and President for Academic Affairs for the Mount Sinai Health System, received the Champion of Excellence Award. As Dr. Tewari noted in a video: “I wanted to start a program in prostate cancer. Dr. Charney turned that into a prostate cancer Center of Excellence…He made it one of the most comprehensive programs and not just by telling us how to do it, but by providing every support.”

“I’m proud of where we have come, but I’m not satisfied,” said Dr. Charney, embodying his tireless pursuit of improved outcomes for patients before continuing: “Am I still being innovative? Am I still being inspiring to others? Am I still working with our teams to come up with great ideas? That’s what I think about all the time.”

The event also saw the bestowal of the inaugural Steven Southwick, MD Memorial Award, named in memory of a leading expert on trauma and resilience who passed away from prostate cancer in 2022. Dr. Southwick, Glenn H. Greenberg Professor Emeritus of Psychiatry, PTSD, and Resilience at the Yale School of Medicine, was also mentor and friend to Dr. Charney. “Steve was my buddy, my brother,” said Dr. Charney. “He was brilliant, but that doesn’t capture him. He was the finest person I’ve ever met,” Dr. Charney continued before detailing Dr. Southwick’s contributions to our understanding of post-traumatic stress disorder.

The Steven Southwick, MD Memorial Award recognizes the recipient’s dedication to prostate cancer research and was given to Sujit S. Nair, PhD, an Assistant Professor and Director of Genitourinary Immunotherapy Research in the Department of Urology at Icahn Mount Sinai. Dr. Tewari praised his innovation and hard work, while Dr. Nair noted, “The long-term goal, the fact that we can cure cancer, is the motivation—that’s what excites me.”

Sujit S. Nair, PhD, and Dennis Charney, MD

The final honoree was Robert F. Smith, the Founder, Chairman, and CEO of Vista Equity Partners, who was presented with the Visionary Award for his commitment to addressing the disparity that sees higher rates of prostate cancer—and death—among Black men. Through his collaboration and funding, the Mount Sinai Robert F. Smith Mobile Prostate Cancer Screening unit was launched, a state-of-the-art “doctor’s office on wheels” that takes specialized staff and equipment into the neighborhoods of the men who need it most.

“We’re honoring Robert for being a kind human being,” Dr. Tewari remarked, “a philanthropist, a person who really wants to make an impact, a person who is touched by human lives, a person who cannot take his eyes away from a problem, and if he can make a difference, he does it. He has made a tremendous difference in this cause for prostate cancer.”

Graciously accepting the award, Mr. Smith said, “I’m very hopeful that this is going to be one of those sparks that really leads to a platform of access to health care for the African American community—and save lives.”

With an ambitious goal to reduce deaths from prostate cancer by 25 percent in the Mount Sinai community, this is a spark that will have far-reaching implications. While the event was a celebration of many accomplishments at the Center of Excellence for Prostate Cancer, its true significance may lie in the ongoing inspiration to keep pushing forward at the boundaries of research and patient care.

The Milton and Carroll Petrie Department of Urology at the Mount Sinai Health System has more than 190 urologists on staff, more than any other health care system in New York City. Its robotic surgery program is among the most robust in the country. Genomic testing and advanced imaging are routine for patients with prostate cancer, providing personalized and precise treatment protocols.

Learn more about the Prostate Cancer Research Gala

Committed to Education and Equity: A Q&A With Reena Karani, MD, MHPE, the New Chair of the National Board of Medical Examiners

Updated on May 17, 2023 | Community, Diversity and Inclusion, Featured

Reena Karani, MD, MHPE

Reena Karani, MD, MHPE, Director of the Institute for Medical Education at the Icahn School of Medicine at Mount Sinai, was recently elected Chair of the Board of Directors of the National Board of Medical Examiners (NBME), becoming the first woman of color to serve in this role in the organization’s 108-year history.

The nonprofit organization develops and administers state-of-the-art assessment tools for health professionals across the continuum of education, training, and practice. Dr. Karani and other NBME board members direct the organization’s policy and strategy and ensure the advancement of the organization’s commitments to diversity, equity, and inclusion, among other duties.

Dr. Karani, Professor of Medical Education, Geriatrics and Palliative Medicine, and Medicine, has been integrally involved in educating learners at all levels and has served in a variety of educational leadership roles. She was Senior Associate Dean for Undergraduate Medical Education and Curricular Affairs for more than 10 years before being appointed in 2020 as Director of the Institute, whose mission is to advance teaching, learning, and scholarship in health professions education. Over the years, she has mentored hundreds of trainees and faculty members who are now themselves renowned medical education scholars and change leaders around the country.

“We have integrated into our curriculum core skills related to community-based health, global health, physician advocacy, and human rights,” says Dr. Karani, who received Mount Sinai’s Jacobi Medallion for excellence in 2022. “These are key competencies that we believe our physicians of the future need, and it is our obligation to ensure they are prepared for that future.”

In this Q&A, Dr. Karani discusses her new role, her lifelong commitment to advancing innovative medical education and scholarship both nationally and at Mount Sinai, and her thoughts on addressing bias and inequity in the learning environment.

Reena Karani, MD, MHPE, attends a research presentation with faculty and students at the Icahn School of Medicine at Mount Sinai.

What priorities and directions will you pursue as NBME chair?

The National Board of Medical Examiners is fully invested in offering evidence-based, patient-centered, and bias-free assessment tools for health professionals. I’ve been an active part of those efforts for the past decade through my work as a member of several test material development committees and the Board of Directors. My new role as chair represents an opportunity to strengthen our commitment in two areas I see of particular importance. One is mitigating bias, and the second is continuing to advance the assessment of critical competencies necessary for health care practice in the 21st century. Historically, medical education has taught race as a biologic category based on innate differences that produce health outcomes. Yet this is fundamentally flawed, because race is a social category that reflects the impact of unequal social experiences on health. Centuries of structural racism and bias have contributed to racial and ethnic disparities in health, outcomes, and opportunity. Medicine has a long history of racism and bias, beginning with who is allowed to join the profession and ranging from what is taught and assessed and how clinical care is delivered to the policies, practices, and procedures of our systems. It is everywhere, and there is no more pressing a challenge facing us in health professions education today. We must commit to working tirelessly to face and address these issues. This is not easy, and there are no quick fixes, but we must, for the sake of future generations, commit to this work each and every day. This is a personal journey for me, and an organizational journey that the NBME is fully committed to taking on.

What does being the first woman of color to serve as chair mean to you and to the field?

The enormous privilege and honor of being chair is not lost on me, especially in light of all those who struggled before me and worked tirelessly to have a voice at the table. Being chair of the NBME Board of Directors, indeed, feels amazing, even intimidating, but I have the strength of this highly respected organizations’ staff, my colleagues on the Board, and our faculty from the “house of medicine” to propel me forward. It will also allow me, as a faculty member from Mount Sinai, to advance important conversations about assessment and equity, make meaningful contributions to medical schools and learners, and strive to meet the mission of the organization, which is to protect the health of the public.

U.S. Supreme Court Justice Sonia Sotomayor, center, joined Dr. Karani and colleagues during a 2015 visit to the Icahn School of Medicine at Mount Sinai.

How have your varied positions and activities at Mount Sinai prepared you for your new role?

My 23-year career at Mount Sinai has afforded me an incredible foundation as a professor of medicine, medical education, and geriatrics and palliative medicine. With the support of countless mentors and sponsors, I’ve been privileged to have many educational leadership roles here, and each of these roles, from co-directing the Integrated Medicine-Geriatrics Clerkship to serving as Senior Associate Dean for Undergraduate Medical Education and Curricular Affairs, has helped prepare me for this new role.

At the end of 2020, I became Director of the Institute for Medical Education, which is the organizational core that fosters the development and dissemination of best practices and scholarly innovations in teaching and learning, and serves as the trusted professional development source for health professions’ educators and scholars. We are proud to serve as an inclusive home for all medical educators and, as such, all our programming is designed to help educator faculty achieve their full potential.

One focus of your career has been geriatric medicine and palliative care. Why is it important to integrate geriatrics and palliative medicine training into the medical curriculum?

No matter what field of medicine an individual practices, they are going to care for and connect with older people. Even in pediatrics, there are many children in this country who are being raised by their grandparents. In addition, the key competencies in palliative medicine of providing quality care to those with serious illness are also critical no matter what field of medicine a person chooses to practice. So we have a responsibility to teach and assess the key skills and behaviors necessary to care for older people and those with serious illnesses across the continuum of medical education.

I’ve had great opportunities through my work at Mount Sinai to bring these geriatrics and palliative medicine perspectives forward. We have integrated and created opportunities: We’ve woven relevant learning into courses and clerkships, such as how human physiology changes as one ages, what the impact of aging is on pharmacology and pharmacodynamics, and how aging affects mobility and function as part of the study of the musculoskeletal system. And, we also proudly offer a required clerkship in geriatrics and palliative medicine that occurs during the third year of a medical student’s training at Mount Sinai. This allows our trainees to learn from and be mentored by our world-class faculty in geriatrics and palliative medicine.

Is there anything else you’d like to share about your new opportunities and challenges as National Board chair?

I believe my new role sends a strong message to the medical community about the Board’s commitment to ensuring diversity, equity, and justice in all aspects of health professional assessment. Just as importantly, I hope that young faculty see it as an invitation for them to get involved with our organization—to help us build assessments that are relevant and patient-focused and designed to correct the biases of the past for health professionals of the future. I also believe it’s important that young learners, particularly those of color and from historically excluded groups, see the many opportunities that are available to them and reach out to me if there are ways I can support them.

The Selikoff Centers for Occupational Health at Mount Sinai Provide Undocumented Immigrant Workers With the Care They Need

Updated on Mar 14, 2023 | Community, Diversity and Inclusion, Featured

Many of the approximately eight million undocumented immigrants in the United States workforce hold critical and essential jobs. Some of these jobs are in construction, cleaning services, transportation—jobs that ensure we have everything from electric power to groceries to child care.

Undocumented workers are more likely to suffer work-related injury or illness than native-born workers, and more likely to experience dangerous working conditions than documented immigrants.

Yet undocumented immigrant workers are less likely to seek care and benefits for their work-related injury or illness.

There are many reasons for this: fear of employer retaliation, including wage theft, firing, and deportation; lack of awareness of rights and resources; intimidation by complex systems and processes; and mistrust in government and health care institutions. Anti-immigrant rhetoric in the United States intensifies many of these fears.

The Selikoff Centers for Occupational Health at Mount Sinai are dedicated to providing all workers, including undocumented immigrant workers, with the care they need.

Michael Crane, MD, MPH

“All workers have the right to health and safety on the job. It is essential that undocumented workers be made aware of and connected to the services they need and deserve,” says Michael Crane, MD, MPH, Medical Director of the Selikoff Centers. “We are dedicated to providing the highest quality care to all workers across our community, including those who are undocumented.”

Undocumented workers have rights and protections under health, safety, and anti-discrimination laws. The Selikoff Centers for Occupational Health at Mount Sinai, as part of its mission through the New York State Occupational Health Clinic Network, provides no-cost, confidential health care and other support services to all workers who have suffered a work-related injury or illness, regardless of documentation or insurance status. This includes evaluation, diagnosis, and treatment of work-related conditions. Services also include screenings for hazardous exposures (such as asbestos, lead, and other toxins), injury prevention, benefits counseling, and social work services.

“As members of the New York State Occupational Health Clinic Network, we provide health and safety-related services designed to reduce workplace injuries and illnesses,” says Dr. Crane, who is also a Professor of Environmental Medicine and Public Health at the Icahn School of Medicine at Mount Sinai. “We diagnose and treat ill and injured workers with the goal of safely returning them to work. Our doctors are experts in occupational medicine who understand work-related injury and help their patients obtain appropriate Workers’ Compensation benefits. Our patients may also avail themselves of the guidance and support of our experts in ergonomics, industrial hygiene, social work, and vocational counseling.”

Agata Bednarska

Undocumented workers are eligible for New York State Workers’ Compensation. This law provides benefits for lost wages and medical treatment when a worker becomes sick or injured because of their job. At the Selikoff Centers, Workers’ Compensation coordinators guide patients through the process, which can be overwhelming and confusing. This is especially important for those facing language barriers or who are mistrustful of government systems.

“Navigating the New York State Workers’ Compensation system can be challenging for many injured and sick workers” says Agata Bednarska, Outreach and Education Manager. “Our Workers’ Compensation coordinators are here to educate, support, and assist patients with filing for New York State Workers’ Compensation benefits. We place significant emphasis on educating our patients about their legal rights. Advocacy, education, and treatment by our specialists can reduce the very significant economic burden of injury or illness on the worker and their family.”

Meet Rachel Vreeman, MD, MS, Director of the Arnhold Institute for Global Health at Mount Sinai

Updated on Mar 21, 2023 | Adolescent Health, AIGH, Featured

“I never wanted to be in a lab or doing statistics, but I absolutely love asking questions about how to best provide care for kids.” – Rachel Vreeman, MD, MS, Director of the Arnhold Institute for Global Health.

Rachel Vreeman, MD, MS, is Chair of the Department of Global Health and Health System Design at the Icahn School of Medicine at Mount Sinai and the Director of the Arnhold Institute for Global Health. A pediatrician and researcher, she also continues her research work around HIV, with a focus on East Africa, as well as other global work related to children and adolescents living with HIV.

In addition, Dr. Vreeman chairs the Global Pediatric Working Group for the International Epidemiologic Databases Evaluating AIDS (IeDeA) consortium, a global consortium of HIV care programs funded by the National Institutes of Health that compiles data for more than two million people living with HIV.

Prior to joining Mount Sinai in 2019, she served as Director of Research for the Indiana University Center for Global Health and for the AMPATH Research Network, and was an Associate Professor of Pediatrics at the Indiana University School of Medicine and the Joe and Sarah Ellen Mamlin Scholar for Global Health Research. She received her bachelor’s degree from Cornell University where she majored in English literature. She has a master’s degree in clinical research from Indiana University School of Medicine and a medical degree from Michigan State University College of Human Medicine.

In this Q&A, Dr. Vreeman, who is also a best-selling author of books that debunk medical myths, discusses her vision for the Arnhold Institute for Global Health, how she has witnessed the transformation of care for children with HIV, and what it takes to be a good doctor and researcher.

Can you tell us a little bit about yourself and your background?

I am a pediatrician and researcher who specializes in trying to figure out how to improve care for children and adolescents growing up with HIV all around the world. I have worked for almost the last 20 years in a partnership in Kenya, growing a health care system for families with HIV and engaging with Kenyan partners around how we can best treat HIV in places like East Africa. I grew up in Michigan, then went to college at Cornell, medical school at Michigan State University, and trained in pediatrics at Indiana University. At Indiana University, I was introduced to global health through a long-standing partnership called the Academic Model Providing Access to Healthcare in Kenya, a 30-plus-year partnership between North American medical schools and a medical school and hospital system in western Kenya. I started spending about six months of the year living and working in Kenya, focused on the care of children with HIV.

One of the things that many people in global health don’t know about me is that I’ve co-authored three best-selling books that debunk medical myths people tend to hold about their bodies and health. This myth-busting has given me lots of interesting opportunities to talk about science and health; it has been featured in The New York Times, USA Today, The Los Angeles Times, Newsweek, and many other publications and on various television and radio shows such as Good Morning America and CNN.

A pediatrician and researcher, Rachel Vreeman, MD, MS, Director of the Arnhold Institute for Global Health, is also a best selling author. Here three books she co-authored:

Don’t Swallow Your Gum: Myths, Half-Truths, and Outright Lies about your Body and Health
Don’t Cross Your Eyes…They’ll Get Stuck Like That! And 75 Other Health Myths Debunked
Don’t Put THAT in THERE! And 69 Other Sex Myths Debunked

What is your vision for the Institute?

My vision for the Institute is that we would grow and deepen a small set of global health partnerships that radically improve the health systems in the places where we are partnering—and that these partnerships would model equity, sustainability, mutual trust, and mutual benefits. Through these kinds of partnerships, I believe the Arnhold Institute for Global Health will be able to move forward research, health care delivery, and educational opportunities that transform health care systems for vulnerable populations. Right now, we are growing these partnerships in Kenya, Nepal, Ghana, and New York City, and we are starting to see the first glimpses of how these partnerships can meet the health needs of populations such as adolescents living with HIV, neighborhoods with diverse populations struggling through COVID-19 spikes, pregnant people with unacceptably high rates of deaths and complications, and people seeking care for chronic diseases like hypertension in rural communities. I cannot wait to see our work like this continue to grow through the partnerships we have formed with academic medical centers, health systems, and government public health partners.

Nima Lama, left, Minister of Health for Bagmati Province in Nepal, presents Dr. Vreeman with a Nepali gift.

How did you get into the adolescent health field?

The most incredible privilege of my career has been the opportunity to become a pediatrician who can focus on supporting adolescents and young adults globally, including those who are living with HIV. In the early years that I worked in Kenya, our hospital wards and our clinics were full of young children who were dying from HIV. Two-year-olds, 3-year-olds, 4-year-olds. I did not take care of more than a handful of older kids. None of the kids born with HIV lived that long.

And now, our clinics in Kenya are such very different places. They are full of teenagers doing teenager things. Going to school, struggling through becoming adults, making friends and arguing with friends. All the good stuff and all the hard stuff. And HIV is now a chronic disease that they are living with. I love getting to watch youth transform not only their own stories, but also start to transform our world. It is the most inspiring, hope-bringing, sometime scary, but always precious thing.

Adolescence is this critical time for youth—the time that often decides whether a person stays in school, remains free of infections like HIV, whether they get pregnant young or not, what their use of drugs or alcohol might look like, and how their social circles develop. But most global health systems have very few services to support all aspects of adolescent health. There are often not places for adolescents to get vaccines or mental health support or family planning services—let alone basic check-ups. Now, I get to focus much of my own work on growing care programs to support adolescent health in places like Kenya.

What is the best part of your job?

I love new ideas. And I love tackling big problems. The very best part of my job is getting to support our multinational teams as everyone collaborates to dream up new ideas that provide better health care and better access to health care for people around the world.

What are you most excited about for the future of the Institute?

At the Institute, we now have the opportunity to change how health care is provided for big groups of people, often living in poor or remote places around the world. We even have the opportunity to work on national health systems and revamping how they provide care to populations like women and children. Being able to have this kind of impact, to be able to be part of scaling up better and more just systems—especially to serve children and women—is so exciting to me.

Do you have any advice for someone looking to go into your field?

I would not be afraid to bring all of yourself to the work that you want to do. For example, I thought that being a book-loving, former English major who loves stories was an interesting part of who I was, but I never thought that it would be part of what it looked like to be a good doctor. In fact, when I started medical school, I thought it might be a real liability that I did not have the kind of science background that many of my peers do. Instead, I learned over time that how we care for people as patients requires us to be very good listeners to their stories. Even more, it is critical to the work I do every single day that I can capture our ideas and their significance in writing.

And, it always helps to stay curious. Once I was in pediatrics, I did not really have any idea what kind of specialty area or focus I might want. I loved taking care of children and addressing the needs of their families, and I had never once thought about a research career. After seeking and questioning during my years of residency, it took a smart mentor to point out to me that I really love working to try to fix health care systems so that they provide better care for the most vulnerable children and their families—and that this was what health services researchers do. I begrudgingly agreed to try out a research elective and quickly discovered that my love of figuring out ideas for how to fix things was actually the perfect basis for growing research. I never wanted to be in a lab or doing statistics, but I absolutely love asking questions about how to best provide care for kids.

Mount Sinai Physicians Aid Colleagues in War-Torn Ukraine

Mar 9, 2023 | Community, Featured

In Ukraine, doctors are working to continue giving quality care to patients with inflammatory bowel disease. Mount Sinai has stepped in to help by offering courses over Zoom with more than 250 doctors.

Amid the ongoing war in Ukraine, doctors are desperate to continue giving quality care to patients with inflammatory bowel disease (IBD), a condition that causes chronic inflammation of the gastrointestinal tract. Determined to help, Jean-Frederic Colombel, MD, and his team created the “Mount Sinai IBD Course for Ukraine,” a series of remote courses that support IBD doctors in the country. “As soon as I was aware that there was a need, I immediately said ‘yes,’” says Dr. Colombel, Director of the Susan and Leonard Feinstein IBD Clinical Center and the Leona M. and Harry B. Helmsley Charitable Trust IBD Center at Mount Sinai, and Professor of Medicine (Gastroenterology). “Also, because I’m European, I’m very emotional about what’s going on in Ukraine, because I know several of these doctors.”

Jean-Frederic Colombel, MD

As an IBD specialist who practiced in his home country of France before joining Mount Sinai in 2013, and who served as President of the European Crohn´s and Colitis Organisation from 2008 to 2010, Dr. Colombel was in a unique position to help. Working closely with his network of colleagues both within and outside of Mount Sinai, Dr. Colombel and his team organized the series of courses over Zoom. In all, three courses have been held since August so far, with up to 250 Ukrainian doctors attending both live and recorded video sessions. Dr. Oleksandr (Alex) Shumeiko, a Ukrainian gastroenterologist currently undergoing training at the University of Cincinnati, worked closely with Dr. Colombel to organize the courses and helped spread awareness among colleagues in his home country.

Ukraine is a leader among Eastern European countries in the field of IBD. However, the war has forced many doctors there to rethink how they treat patients—using minimal resources, rather than the latest developments and innovations in their field. “Because of the war, it was back to some basics, and how to deal with that,” Dr. Colombel explains.

Since the war began a year ago last February, patients and doctors have faced multiple dilemmas— disruption of logistics, the closure of hospitals under constant shelling, damage to energy grids—all of which makes it almost impossible to provide quality diagnoses and treatments for patients. Many health care workers and patients have become refugees or were displaced, partially or completely unable to access IBD treatment. Before the war, Ukrainian centers were tightly involved in clinical trials for IBD, providing opportunities for advanced therapies and cutting-edge medical care. Now, those trials have closed and many hospitals have lost resources to provide adequate IBD care. As a result, most patients are relying on humanitarian efforts to receive treatment.

As the war continues to disrupt health care systems, Mount Sinai’s IBD Course for Ukraine is helping Ukrainian physicians support IBD patients with minimal resources. For example, one course trained doctors in the management of long-term use of steroids for patients with IBD. While not recommended under normal circumstances, Dr. Colombel says the treatment is necessary for patients in Ukraine. “Because the typical biologics prescribed to IBD patients are not available due to the war, Ukrainian doctors wanted to learn how to minimize the side effects of steroids, which was sometimes the only treatment option,” Dr. Colombel says.

In fact, a majority of the courses have focused on practical topics, such as managing stomas following surgery, optimizing nutrition, treating IBD during pregnancy, caring for children with IBD, surgical options for IBD patients, and more. When Dr. Colombel asked Mount Sinai colleagues with IBD expertise to participate, many were eager to help. “This was extra work for all of them, but everybody was very enthusiastic. And actually, we had almost too many people who wanted to participate.”

The courses “perfectly align” with Mount Sinai’s core values of creativity, empathy, and teamwork in times of crisis, he says, because they offer “the best education for doctors in the Ukraine to provide the best care for all their patients, rather than a select group of patients who are the most wealthy.”

While organizing the courses over Zoom was relatively simple, Dr. Colombel says it was “very emotional,” because some doctors attended a live course in Kharkiv while missiles struck the city. He imagined what it would be like to provide care to patients under similar circumstances. “This would be a heartbreaker,” he says. “Very often, we don’t think about the consequences for doctors and patients to be at war like that. It is not like Ukraine is a country that never had access to the best care—they had access to very good care before, and then, suddenly, boom—nothing. So this is a big deal.”

Aside from helping doctors in Ukraine access the knowledge they need to treat patients, Dr. Colombel says it was just as important for them to see that their colleagues outside Ukraine were willing to help.

“Any sign of solidarity that you can bring for them, psychologically, is very important,” he says.

A damaged operating room inside a Ukrainian IBD center.

Ukranian IBD doctors examine an image together

Ukranian doctors meet for training on how to use diesel generators

FREEDOM Trial Finds That High-Dose Anticoagulation Can Improve Survival for Hospitalized COVID-19 Patients

Mar 7, 2023 | Cardiology, COVID-19, Featured, Research

The FREEDOM trial was initiated and led by Valentin Fuster, MD, PhD, President of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.

An international trial led by Mount Sinai found that high-dose anticoagulation can reduce deaths by 30 percent and intubations by 25 percent in hospitalized COVID-19 patients who are not critically ill, when compared to the standard treatment, which is low-dose anticoagulation. The innovative FREEDOM trial was initiated and led by Valentin Fuster, MD, PhD, President of Mount Sinai Heart and Physician-in-Chief of The Mount Sinai Hospital.

The study results were announced Monday, March 6, in a late-breaking clinical trial presentation at the scientific sessions of the American College of Cardiology Together With World Congress of Cardiology (ACC.23/WCC) in New Orleans and simultaneously published in the Journal of the American College of Cardiology.

“What we learned from this trial is that many patients hospitalized with COVID-19 with pulmonary involvement, but not yet in the intensive care unit (ICU), will benefit from high-dose subcutaneous enoxaparin or oral apixaban to inhibit thrombosis and the progression of the disease,” Dr. Fuster says. “This is the first study to show that high-dose anticoagulation may improve survival in this patient population—a major finding since COVID-19 deaths are still prevalent.”

Clinical Insights, Early in the Pandemic

This work was prompted by the discovery early in the pandemic that many patients hospitalized with COVID-19 developed high levels of life-threatening blood clots. In March 2020, during the early days of the pandemic, Dr. Fuster observed patients with blood clots in their legs who had been admitted with COVID-19. After hearing from colleagues abroad of other cases of small, pervasive, and unusual clotting that had triggered myocardial infarctions, strokes, and pulmonary embolisms, he initiated decisive action.

“We became one of the first medical centers in the world to treat all COVID-19 patients with anticoagulant medications,” says Dr. Fuster, a pioneer in the study of atherothrombotic disease. “It was a decision that we believe saved many lives.”

This early protocol led to groundbreaking research and insights by Mount Sinai into the role of anticoagulation in the management of COVID-19-infected patients. Mount Sinai research showed that treatment with prophylactic (low-dose) anticoagulation was associated with improved outcomes both in and out of the intensive care unit among hospitalized COVID-19 patients. Researchers further observed that therapeutic (high-dose) anticoagulation might lead to better results. Then, they designed the FREEDOM COVID Anticoagulation Strategy Randomized Trial to look further into the most effective regimen and dosage for improving outcomes of hospitalized COVID-19 patients who are not critically ill.

Researchers enrolled 3,398 hospitalized adult patients with confirmed COVID-19 (median age 53) from 76 urban and rural hospitals across 10 countries—including hospitals within the Mount Sinai Health System—between August 26, 2020, and September 19, 2022. Patients were not in the ICU or intubated, and about half of them had signs of COVID-19 impacting their lungs with acute respiratory distress syndrome (ARDS). Patients were randomized to receive doses of three different types of anticoagulants within 24 to 48 hours of being admitted to the hospital and followed for 30 days. Equal numbers of patients were treated with one of three different drug regimens: low-dose injections of enoxaparin, high-dose injections of enoxaparin, and high-dose, oral doses of apixaban. They compared the combined therapeutic groups to the prophylactic group.

Informing Future Care

The primary endpoint was a combination of death, requirement for ICU care, systemic thromboembolism (blood clots traveling through the arteries), or ischemic stroke at 30 days. This endpoint was not significantly reduced among the groups. However, 30-day mortality was lower for those treated with high-dose anticoagulation compared with those on the low-dose regimen. Seven percent of patients treated with the low-dose anticoagulation died within 30 days, compared with 4.9 percent of patients treated with high-dose anticoagulation—an overall reduction of 30 percent. The need for intubations was also reduced in the high-dose group: 6.4 percent of patients on the high-dose regimen were intubated within 30 days compared with 8.4 percent in the low-dose group—a 25 percent reduction. The study showed high-dose anticoagulation to be especially beneficial for patients with ARDS, a condition where COVID-19 damages the lungs. Among patients with ARDS at the time of hospital admission, 12.3 percent in the low-dose anticoagulation group died within 30 days, compared with 7.9 in the high-dose group.

All groups had low bleeding rates, and there were no differences between the two therapeutic blood thinners for safety and efficacy.

“This is an important study for patients with COVID-19 who are sick enough to require hospitalization but not so ill as to require ICU management. In this group of patients with radiologic evidence of ARDS, therapeutic dose anticoagulation prevents disease progression, especially the need for intubation, and saves lives,” says co-Principal Investigator Gregg W. Stone, MD, Professor of Medicine (Cardiology), and Population Health Science and Policy, at the Icahn School of Medicine at Mount Sinai. “This is especially important as COVID-19 is not going away. Even in the United States, the current number of daily deaths, although much lower than at the peak of the pandemic, is twice that compared with just one year ago. And in other countries COVID-19 is raging”

The FREEDOM trial was coordinated by the Mount Sinai Heart Health System. Dr. Fuster raised all funding for the trial.

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