Mount Sinai Receives U.S. Military Contract to Identify Exposure to Weaponized Infectious Agents

One of the greatest challenges facing the U.S. military is being able to determine, definitively, whether troops serving in combat zones have been exposed to weaponized infectious agents, chemicals, or radiation, or if someone has been working with materials used in making weapons of mass destruction. This knowledge would enable the U.S. military to respond immediately.

The Icahn School of Medicine at Mount Sinai is now taking an active role in such a national security initiative, which was launched recently by the Defense Advanced Research Projects Agency (DARPA)—an arm of the U.S. Department of Defense. Under the four-year, $27.8 million contract, Mount Sinai researchers and colleagues from industry and other academic institutions will work together to explore new methods of finding molecular signatures in blood that can identify exposures and the time of exposure. They will also develop field-deployable instruments that can perform these sensitive forensic and diagnostic analyses.

“The human body logs exposures in a rich biographical record that we carry around with us in our epigenomes,” says Stuart Sealfon, MD, Professor of Neurology at the Icahn School of

Principal Investigator Stuart Sealfon, MD, right, with research team members from the Department of Neurology: Elena Zaslavsky, PhD, Assistant Professor, and Venugopalan Nair, PhD, Associate Professor.

Medicine at Mount Sinai, and Principal Investigator on the contract, which is part of DARPA’s new Epigenetic Characterization and Observation (ECHO) program. “The ECHO technology we’re developing will enable us to quickly read someone’s epigenome from a small amount of blood and measure any changes in the cells to accurately predict exposure to hazardous agents or materials.”

Current forensic and diagnostic screening methods require large instruments and are unable to detect previous exposure, according to Dr. Sealfon. The researchers will focus on creating advanced microfluidic instrumentation with a reduced footprint that can be easily deployed and moved around battlefields for the sequencing and analysis of human cells. “This level of portability could enhance the military’s ability to conduct timely surveillance of emerging threats around the world where U.S. troops or our allies are actively engaged,” he says. It could also make a difference by ensuring that medical countermeasures are undertaken when soldiers encounter hazardous nerve agents, such as sarin and VX, or other toxic agents, such as phosgene and chlorine.

Mount Sinai will draw on its considerable experience in the fields of genomics, proteomics, and epigenomics over the course of the research project. In order to detect epigenetic markers in small amounts of blood, the researchers will also leverage their strengths in the rapidly unfolding science of single cell biology. “My laboratory is an integrated computational and experimental group with cell biologists, molecular biologists, computer scientists bioinformaticists, physicists, mathematic modelers, and database developers,” Dr. Sealfon says. “We are also fortunate to have outstanding collaborators within Mount Sinai—including Robert Sebra, PhD, Associate Professor, Department of Genetics and Genomic Sciences, and his lab—and from outside laboratories, since that gives us a broader range of expertise.”

Defense security is only one aspect of the project funded by DARPA. Just as important, according to Dr. Sealfon, is the potential application of ECHO technology in general medicine. “It could be valuable in the field of infectious disease, for example, to quickly and reliably predict if someone has a bacterial or viral infection during the influenza season, giving patients a point-of-care benefit,” he says. Another possible outgrowth of the DARPA work is the development of basic research instruments that could generate epigenetic data on single cells within minutes. “It’s likely that medical applications from this research program will be realized in a shorter time frame than those on the military side, which are more demanding,” Dr. Sealfon says. “This may result, for example, in the next-generation sequencing technology making many of the genomic analyses we now do much faster, easier, and more accessible.”

Study Links Dust at Ground Zero to Prostate Cancer

Eighteen years after the September 11 attacks, Mount Sinai Health System researchers have found a higher incidence of prostate cancer among the World Trade Center (WTC) first responders than other populations, suggesting that chronic inflammation can facilitate the development of prostate cancer.

Emanuela Taioli, MD, PhD; and William Oh, MD

The most recent findings, published in June in Molecular Cancer Research, were led by Emanuela Taioli, MD, PhD, Director of the Institute for Translational Epidemiology and Associate Director for Population Science at The Tisch Cancer Institute; and William Oh, MD, Chief of the Division of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai, and Deputy Director of The Tisch Cancer Institute.

“Our research supports the first line of evidence that acute World Trade Center dust exposure through inhalation can profoundly disturb gene expression and immune cell infiltration in the prostate,” says Dr. Taioli.

While working at Ground Zero, the first responders did not wear protective gear and were exposed to dust particles composed of volatile organic compounds from jet fuel, as well as asbestos, benzene, silica, glass fibers, polychlorinated biphenyls, polychlorinated dibenzofurans, and dioxins from the collapsed buildings. Given the fine particulate nature of the WTC dust, the researchers hypothesize that the toxins entered the blood through the lungs and eventually reached the prostate and other distal organs.

“The results of this study support our hypothesis that exposure to the dust at the World Trade Center caused chronic changes in the body,” says Dr. Oh. “The long-lasting inflammatory effect in the prostate revealed in our study calls for further investigation as to the effect of this exposure in other organs, such as the kidney or thyroid, or the central nervous system.”

In 2018, Dr. Taioli led a study published in the European Journal of Cancer Prevention, which reported that responders who spent more time working at Ground Zero and had a higher exposure to the dust cloud that formed after the WTC buildings collapsed, had more advanced stages of prostate cancer—stages III and IV—representing tumor invasion. Interestingly, the 2018 study found that at the beginning of their service at the WTC, the responders were mostly nonsmokers of diverse ethnic backgrounds who were considerably healthier than the general population and at lower risk for cancer.

According to the recent 2019 report, approximately 20 percent of human cancers are thought to be caused by chronic infection or inflammatory states, and chronically unresolved inflammation is related to increased risk of malignant disease. When tested in the laboratory, the toxic dust was shown to induce the secretion of cytokines— small proteins involved in modulating responses to inflammation infection, cancer, and trauma.

Mount Sinai runs the largest World Trade Center Health Program Clinical Center of Excellence in the New York metropolitan region, with 25,000 patients who have consented to participate in research. A biobank of more than 600 cancer samples from first responders has helped lay the groundwork for Mount Sinai’s WTC research findings.

Dr. Taioli says the latest research raises additional questions about whether air pollution, in general, causes an inflammatory response in people. “This work has larger implications for the population exposed to environmental particulates, such as emissions from motor vehicles, industrial processes, power generation, and the household combustion of solid fuel,” she says. “Inflammation could be the common pathway driving an increase in cancer occurrence.”

Personalized Digital Health Screenings at Lab 100

Tucked away in an office on the campus of the Icahn School of Medicine at Mount Sinai is a futuristic medical clinic—Lab 100—that provides patients with a 90-minute comprehensive health checkup using the latest technology to measure their vital signs, their strength, cognition, balance, and dexterity. Designed as a complement to a primary care visit, Lab 100, which opened to the public in October 2018, provides patients with information that can help them lead a healthier lifestyle. It serves as a digital biometric health screening that alerts patients and practitioners to areas of their health they need to improve, such as poor sleep habits or a stronger core that can be achieved through yoga or a different exercise routine.

“Our goal is to empower patients by rapidly and transparently providing them with their own personalized health data,” says Marina Gazayeva, NP, Lab 100.

Lab 100 patients fill out an online questionnaire in advance of their appointments. When they arrive at the clinic, they visit eight health stations, including one that measures their body fat ratio and skeletal muscle mass. At the conclusion of the visit, their health results are posted on a large digital screen that serves as a point of discussion between the patient and a Lab 100 nurse practitioner. Within 24 hours after their visit, patients receive a health report card of their results, with recommendations for improving their health.

The cost of a visit, which is not covered by medical insurance but may be covered through a health spending account, is $199 for Mount Sinai Health System employees and $399 for nonemployees.

Specialty Pharmacy Adds Access to Complex Therapies

Donald Mashni, PharmD, right, with David L. Reich, MD, center, and José Almonte, Director, Specialty Pharmacy Call Center.

A new option is now available for Mount Sinai Health System patients and employees who have rare or chronic disorders that require complex medications such as immunotherapy or chemotherapy—the Mount Sinai Specialty Pharmacy. The facility, which opened in June at The Mount Sinai Hospital, helps patients seek insurance approval and financial assistance, and relieves the administrative burden of physicians, with the ultimate goal of improving patient outcomes.

“The Mount Sinai Specialty Pharmacy will offer patient-focused, convenient, and affordable services for all our patients,” says Donald Mashni, PharmD, Director, Specialty and Outpatient Pharmacy, Mount Sinai Health System. Specialty pharmacies dispense complex medications that require special storage and handling and ongoing clinical support and monitoring by specially trained pharmacists.

When patients and doctors present specialty prescriptions to the Mount Sinai Specialty Pharmacy, the pharmacy staff can assume the important tasks of securing insurance approval, financial assistance, and clinical counseling. Pharmacy staff also coordinate delivery to the patient’s home or to the physician’s office. “Our facility will tie everything together,” Mr. Mashni says. “The goal is to keep all patient care inhouse, from diagnosis through post-treatment follow-up. This approach provides thorough and immediate communication among pharmacists and specialists. It also improves the efficiency and accuracy of the medications.”

For example, one commonly prescribed specialty drug is adalimumab, or Humira, an advanced biologic medication for severe Crohn’s disease and rheumatoid arthritis. Patients inject a pre-filled syringe every other week. The drug must be refrigerated, and each syringe must be used in full and injected in the thigh or stomach, in a different spot each time. The patient should not skip a dose or stop taking the medication without consulting a physician or pharmacist. “Adherence to the treatment schedule is critically important,” Mr. Mashni says. “It maximizes the benefit patients get from the medication and improves outcomes.”

Specialty medications once were a niche market. But advances in drug research mean they are available for many more conditions. The U.S. Food and Drug Administration approved 39 new specialty medications in 2018, according to Specialty Pharmacy Times, and because they can be so costly, specialty drugs are expected to account for almost 50 percent of drug spending by 2020, although they represent only about 2 percent of the total prescriptions filled.

The Mount Sinai Specialty Pharmacy is launching services in therapeutic categories that include HIV, hepatitis C, inflammatory bowel disease, rheumatology, dermatology, and oncology. It shares space with the Mount Sinai employee pharmacy in the Annenberg Building and functions like a traditional specialty pharmacy but with the advantage of full integration with Mount Sinai’s hospitals and physicians. The Health System also operates two other specialty pharmacies, which are part of the Institute for Advanced Medicine and specialize in treating patients with HIV. They are the West Village Pharmacy, at the Center for Transgender Medicine and Surgery, and the St. Luke’s-Roosevelt Outpatient Pharmacy in the Samuels Clinic at Mount Sinai West.

A new Call Center, adjacent to the Mount Sinai Specialty Pharmacy at The Mount Sinai Hospital, is centralizing all of the Health System’s specialty pharmacy services and fulfillment, with Call Center staff coordinating prior authorization, financial assistance, and delivery of medications. These services are essential as the Mount Sinai Specialty Pharmacy is seeking accreditation from URAC, the gold-standard accrediting body for specialty pharmacies. URAC accreditation will allow the pharmacy to gain access to more limited-distribution drugs and get contracts with more insurance plans.

“The Specialty Pharmacy is enabling Mount Sinai to provide seamless service for patients with complex and chronic illnesses, from diagnosis through treatment and long-term aftercare,” says David L. Reich, MD, President and Chief Operating Officer of The Mount Sinai Hospital, and President of Mount Sinai Queens.

International Yoga Day, and Beyond

Faculty and staff of the Department of Medicine (Cardiology) took part in International Yoga Day. Front row, from right: Annapoorna S. Kini, MD; Lori B. Croft, MD, Associate Professor; and Joseph M. Sweeny, MD, Assistant Professor.

Mount Sinai Heart faculty and staff recently participated in International Yoga Day at Guggenheim Pavilion, with multiple sessions starting at 7:30 am. However, the enthusiasm for the practice goes well beyond a one-day event. The organizer, Annapoorna S. Kini, MD, Director of the Cardiac Catheterization Laboratory at The Mount Sinai Hospital, and the Zena and Michael A. Wiener Professor of Medicine, Icahn School of Medicine at Mount Sinai, practices yoga herself and recently published a list of recommended yoga and meditation techniques in the CRT Times, including a 10-minute sequence specifically for physicians in the Cardiac Catheterization Laboratory.

Dr. Kini says, “At Mount Sinai, we strongly advocate yoga and meditation to counter musculoskeletal discomfort, to relieve stress, and to maintain focus and concentration.”

Inaugural Health Care Inclusion Summit Provides a Road Map to Positive Change

From left: panelists David Muller, MD, FACP; Erica Rubinstein, LCSW; and Chaplain Rocky Walker, MDiv; keynote speaker Mary-Frances Winters; Pamela Y. Abner, MPA; panel moderator Maxine Legall, MBA, MSW; and Gary C. Butts, MD, Dean for Diversity Programs, Policy and Community Affairs, Icahn School of Medicine at Mount Sinai.

Participants received information on efforts throughout the Mount Sinai Health System.

At a networking and informational session, Nolan Kagetsu, MD, FACR, left, Vice Chair Quality, Associate Professor of Clinical Radiology, Department of Radiology, Mount Sinai West, talks with Mari Umpierre, PhD, LCSW, Director, Mount Sinai Calm, right, and Shehan Chin, LMSW.

From left: Edgar Vargas, MPH, LMSW, LGBT Program Manager; Leona Hess, PhD, Director of Strategy and Equity Education Programs; and Bee Jaworski, Education Program Assistant in Medical Education

At the start of a meeting, give participants a few moments to reflect quietly on the subject at hand, then call on each person for their thoughts. When people do speak, “listen to understand, and not to reply.”

These were some of the specific and achievable strategies discussed in the inaugural Health Care Inclusion Summit, which was in June at the Corporate Services Center and sponsored by leadership in Service Excellence and Patient Experience.

The keynote speaker of the event was Mary-Frances Winters, founder and Chief Executive Officer of the Winters Group, a consulting firm that has been working with top leaders of the Mount Sinai Health System on inclusion strategies for more than a year. “It is important to recognize that inclusion is a developmental process,” Ms. Winters said. “We must address changes in attitudes one stage at a time.”

Leona Hess, PhD, left, and Ann-Gel Palermo, DrPH, MPH, led a discussion on the mindsets of inclusive change makers.

Ms. Winters used an interactive tool to ask the 150 attendees how they defined themselves. The anonymous answers appeared on a screen at the front of the room:  A daughter, a Buddhist, an African American mom, a gay man, a husband, a millennial, a person with ADHD. These “identity markers”—some visible and some not visible—influence how each person sees and reacts to the world, Ms. Winters said, and understanding this is the beginning of understanding and accepting others.

Panelists during the half-day summit were David Muller, MD, FACP, Dean for Medical Education, Icahn School of Medicine at Mount Sinai; Chaplain Rocky Walker, MDiv, Center for Spirituality and Health, Mount Sinai Health System; and Erica Rubinstein, LCSW, CPXP, Vice President, Service Excellence and Patient Experience, Mount Sinai Health System. Maxine Legall, MBA, MSW, Assistant Director, Patient Experience, Mount Sinai St. Luke’s, served as the moderator.

The panelists said that both staff and patients were benefiting from inclusion efforts—which have the overarching goal of making every person feel heard, understood, and respected. Among other measures, the Health System has revamped a panel that addresses patient complaints and created the Strategic Leadership Collaborative to improve equity in medical education. In addition, ODI has expanded its portfolio of education and training on unconscious bias, LGBTQ health care and workplace equity, and cultural and disability awareness.

Leona Hess, PhD, Director of Strategy and Equity Education Programs for Medical Education led a discussion on the mindsets of the inclusive change-maker with Ann-Gel Palermo, DrPH, MPH, and Chief Program Officer. Attendees were advised to focus on how their mindset as a leader was created and how it informs their interactions with staff and patients. “Understanding your own personal and social identity is critical for the development of the skills and behaviors needed to understand, work with, and integrate the perspectives of staff and patients with a diversity of identities.” Dr. Hess said.

Planning is already underway for a summit next year, said Pamela Y. Abner, MPA, CPXP, Vice President and Chief Administrative Officer. “The response has been overwhelmingly positive,” she said after the event.  “We see an opportunity to make inclusion and equity even more integral to patient care, medical education, and every other facet of the Health System.”

Takeaway thoughts

“I have grown into the understanding that others face challenges that I’m not aware of. When I went to seminary for four years, one of my biggest takeaway lessons was what women go through in this world.”

Chaplain Rocky Walker, MDiv

“You have to stay open to different perspectives and different mindsets. Be open to other voices that might challenge you.”

Erica Rubinstein, LCSW, CPXP

“Inclusion begins with I and happens with us.”

Mary-Frances Winters, Founder and Chief Executive Officer of the Winters Group

“I have learned that you have to have humility—professionally and personally. Just take a step back and listen to people.”

David Muller, MD, FACP

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