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IU cancer researcher brings passion for science communication to podcast audience

Tue, 17 Feb 2026 00:00:00 Z

Richard Carpenter, PhD, has always been interested in science communication, but it was a series of chance meetings that led the cancer researcher to add Indiana Public Media podcast host to his resume.

Carpenter, an assistant professor of biochemistry, molecular biology and pharmacology on the Indiana University School of Medicine's Bloomington campus, routinely gives educational presentations to patients, survivors and community members.

"I want to build a bridge between what's going on in research and patient care, and it's important to explain both in a way that non-scientists can understand," said Carpenter, who is also a researcher with the IU Melvin and Bren Simon Comprehensive Cancer Center.

Last summer, Carpenter gave one such talk at the city of Bloomington's Survivor Summit, an annual community event that educates and celebrates cancer survivors and their support communities. An Indiana Public Media employee heard his presentation and recommended he tour the broadcast station.

He then met Indiana Public Media director of content Eric Bolstridge, who told Carpenter about a new podcast series, The State of Inquiry, which had recently featured an expert on artificial intelligence as its guest host. Eventually, the two hammered out the details of a six-episode entry for State of Inquiry called “Hope in Progress,” which would feature Carpenter interviewing his fellow IU cancer researchers.

"I've never done anything like this before," Carpenter said of podcasting, which he noted did not exist when he attended college. "I recruited some of the scientists whom I knew were good talkers, and we used the campus podcasting office."

The series began publishing weekly in January and wrapped up in February. Guests included Maegan L. Capitano, PhD, an assistant professor of microbiology and immunology who studies stem cells, leukemia and other bone marrow disorders, and Mateusz Opyrchal, MD, PhD, an associate professor of medicine in the Division of Hematology/Oncology and the Vera Bradley Foundation Scholar in Breast Cancer Discovery.

Carpenter's guests discuss specific aspects of their research, but the podcast also peels back the curtain on common scientific practices, such as starting a clinical trial.

"The goal of the whole series is to try and communicate the research we are doing in a digestible way," he said. "We take a complex topic and reframe it in a way for someone who might not understand science."

Carpenter said he appreciates his colleagues' willingness to participate, adding that IU’s collegial atmosphere is partly responsible for his decision to set up his lab in Bloomington in 2017.

"There's just a huge support system at IU for cancer researchers," Carpenter said. "My department is set up well for research, and interaction between labs and faculty is easy and comfortable, which is not always the case."

Carpenter's own research is not featured on Hope in Progress. He studies how cells respond to stressors and how those responses can make tumor cells more aggressive and dangerous. He holds a National Institutes of Health grant for a project that looks to block these stress response pathways, which may make breast cancer tumor cells more responsive to treatment.

However, a planned follow-up podcast series from Indiana Public Media will feature Carpenter as a guest. He will be highlighted as an expert on cancer research, while nine other episodes will discuss alternating medical disciplines such as cardiology.

Check out all six episodes of Hope in Progress:

New study identifies tool to measure heart disease risk in testicular cancer survivors

Thu, 12 Feb 2026 00:00:00 Z

A new study by researchers at Indiana University and Medical College of Wisconsin could improve heart health for testicular cancer survivors by helping clinicians predict which patients are at highest risk of cardiovascular disease, a leading cause of illness and death after cure.

Their findings, published today in the Journal of the National Cancer Institute, demonstrate for the first time that the American Heart Association's 2024 Predicting Risk of Cardiovascular Disease Events (PREVENT) equations can identify testicular cancer survivors at heightened risk for future cardiovascular events.

Testicular cancer is the most common cancer in young men, and modern cisplatin-based chemotherapy has pushed survival rates above 95%. However, this success has been accompanied by long-term health consequences, including cardiovascular disease. Until now, clinicians have lacked validated tools to predict which survivors are most vulnerable.

"These findings provide clinicians with a practical, evidence-based tool to identify testicular cancer survivors who are most likely to benefit from early cardiovascular screening and prevention," said Lois B. Travis, MD, ScD, senior author on the study and the Lawrence H. Einhorn Professor of Cancer Research at the IU School of Medicine and IU Melvin and Bren Simon Comprehensive Cancer Center. "Importantly, they also highlight physical activity as a critical intervention that may substantially reduce cardiovascular risk in this young survivor population."

The study evaluated 1,759 long-term testicular cancer survivors treated with cisplatin-based chemotherapy across eight major cancer centers in North America and Europe. Using the PREVENT equations — which incorporate age, blood pressure, cholesterol levels, kidney function, diabetes status, smoking and body mass index — researchers estimated survivors' 10- and 30-year cardiovascular disease risk.

Among survivors followed longitudinally, higher PREVENT-predicted risk strongly correlated with the development of cardiovascular disease:

Each 5% increase in predicted 10-year risk was associated with nearly a three-fold increase in the odds of developing cardiovascular disease within approximately seven years of follow-up.
Survivors classified as having intermediate-to-high risk had more than 12 times the odds of experiencing a cardiovascular event compared with lower-risk survivors

Notably, the association between PREVENT risk and cardiovascular disease was strongest among those who reported no vigorous physical activity at baseline. Survivors who engaged in vigorous physical activity showed a markedly lower risk, underscoring exercise as a powerful, modifiable protective factor.

The predictive accuracy of the PREVENT equations in testicular cancer survivors was comparable to that observed in the general population, reinforcing their usefulness in survivorship care. Because the tool relies on routinely collected clinical data, it can be readily integrated into standard follow-up without additional testing or cost.

The researchers emphasize that cardiovascular risk assessment should become a routine component of long-term survivorship care for testicular cancer patients, alongside monitoring of kidney function, lipid levels, blood pressure and lifestyle factors.

"As more men survive testicular cancer and live for decades after treatment, preventing cardiovascular disease is essential to preserving quality of life and long-term health," said Sarah L. Kerns, PhD, MPH, corresponding author on the study and associate professor of radiation oncology at the Medical College of Wisconsin. "Our study shows that we already have the tools to identify high-risk survivors — and the opportunity to intervene early."

The study was conducted as part of the multi-center Platinum Study and funded by the National Cancer Institute, part of the National Institutes of Health.

IU Center for Bioethics tackles complex issues of humanity surrounding emergent medical technologies

Wed, 27 Aug 2025 00:00:00 Z

New medical breakthroughs bring excitement — and a slew of ethical questions. How can we ensure blockbuster weight loss drugs are accessible to those who need them most? What limits should be placed on AI use in research and patient care? How can blood tests for diseases like Alzheimer’s and cancer be responsibly administered?

These are among the thorny questions explored by researchers at the Indiana University Center for Bioethics.

“There’s all this interaction and overlap and important questions that come up within medicine and medical policy that are about ethics and even questions of philosophy,” said Peter Schwartz, MD, PhD, the center’s director since 2017.

As both a professor of medicine at the IU School of Medicine and a professor of philosophy at IU Indianapolis, Schwartz teaches bioethics to undergraduate and graduate students, including future doctors. Other investigators at the Center for Bioethics include physicians, health care professionals and professors with degrees in areas like law, anthropology, theology and public health policy.

“We are not people who just want to think and write books,” said Schwartz. “We are people who want to improve the practice and provision of health care for the population.”

Schwartz chose a rare dual degree program at the University of Pennsylvania pairing medicine with philosophy. He now combines teaching and research with medical practice as a primary care provider with Eskenazi Health. He is also an IU Health physician, a member of the IU Melvin and Bren Simon Comprehensive Cancer Center and an affiliated scientist with the Regenstrief Institute.

“The whole field of bioethics exists because many people inside of medicine and across society are captivated by the kinds of questions we face in trying to provide great health care,” Schwartz said. “Thinking about health and biology in a modern world where technology goes forward in leaps and bounds, we have to rethink the nature of being a human being, what it means to be healthy, what we expect from health care — these are really essential questions.”

Among other topics, Schwartz studies shared decision making between patients and their physicians, examining measures that attempt to define “decision quality” based on a provider’s communication of treatment options and each patient’s values. As one example, a person’s values might affect how they choose to screen for colon cancer: a colonoscopy, offering a high degree of accuracy, versus a stool test, which is less invasive and more convenient.

Other center investigators focus their research on ethical questions surrounding organ transplantation, genetic testing, biobanks, end-of-life care, reproductive medicine, health care access and research integrity.

“Although we come from different backgrounds, we’re all focused on maximizing the future of health and medicine, and everybody who’s a member of the center is a nationally or internationally recognized expert in their field,” Schwartz said. “The center is a gathering place where people who are doing this kind of work can meet and learn from one another.”

Why doctors and scientists need bioethics training

Every IU medical student receives training in bioethics as part of the curriculum.

“When someone goes into health care, you really hope they would learn not only the skills and competencies to be a provider but also have a perspective on the enormous challenges of the field,” Schwartz said. “This means dealing with difficult moments of life — like birth and death and illness — but also the challenges America has, and really the whole world has, in terms of providing health care, which is so expensive.”

Likewise, it’s important for scientists to learn responsible research conduct and ethics, including avoiding conflicts of interest when working on industry-funded studies. Colin Halverson, PhD, an assistant professor of medicine and investigator with the IU Center for Bioethics, teaches both research ethics and medical ethics at the IU School of Medicine.

“My position blends my interests in ethics, medical anthropology and improving care for patients with rare diseases,” said Halverson, whose research interests include hypermobility syndromes, animal research ethics and AI large language models. “In our courses, we help our students to think critically and empathetically about their patients and research participants and to understand the social contexts and subjective concerns that may fall outside a purely medical perspective.”

Another center investigator, Lauren Nephew, MD, MA, MSc, is a gastroenterologist specializing in liver transplantation. Her interests go far beyond performing a lifesaving surgical procedure — she wants to ensure everyone on the waitlist for a transplant is treated fairly.

“Bioethics training equips physicians with the language and tools to navigate ethical and clinical complexity thoughtfully,” said Nephew, an assistant professor of medicine and associate vice chair of health equity at the IU School of Medicine. “This is especially true in transplant, where life-and-death decisions are made every day.”

She credits Schwartz with cultivating an inclusive gathering place for interdisciplinary dialogue. Schwartz calls it his “dream job.” As center director, he conducts bioethics seminars and workshops at all levels, from continuing professional education to undergraduate courses and even high school events.

“The medical school runs a program called Molecular Medicine in Action where they bring in 50 high school students from across the state and they get to work in labs and hear presentations from scientists,” Schwartz said. “I run a discussion with the room where we talk about the ethics of designing embryos and doing genetic testing and biobanking of tissue samples. It’s really fun.”

Another hot topic of bioethics lately encompasses the wave of novel weight loss drugs, including several injectables like Wegovy and Zepbound, along with a pill in development by Eli Lilly. Many people do not have insurance coverage for these GLP-1 drugs when they are prescribed for obesity.

“I’ve been around long enough to know that the dream of a safe weight loss drug was always there,” Schwartz said. “It’s a miracle with a disaster built in. These drugs can be $1,000 a month. I have patients who are significantly overweight and for whom losing weight would be a medical issue with enormous benefit, but they can’t afford it.

“How do we keep from having thin, rich people and overweight poor people?” he asks.

Schwartz and others are also exploring many facets of how artificial intelligence can be employed ethically in the medical field.

“This is a tornado for health care and for research to have the power of these machines, and it is developing so quickly,” he said. “We are confronted every day with new questions on how to do this right.”

These topics and other ethical inquiries related to informed consent, insulin affordability, genetic testing and more can be found on the IU Bioethics blog.

“Physicians routinely face decisions with significant ethical implications every day, whether it’s delivering difficult news, discussing goals of care, managing resource constraints or addressing systemic inequities,” Nephew said. “Without a foundation in bioethics, even well-meaning providers can unintentionally perpetuate harm or overlook the complex needs of vulnerable populations.”

Cardiovascular risk factors play greater role in adverse outcomes in thymic cancer patients

Tue, 25 Feb 2025 00:00:00 Z

Thymic cancer, a rare type of cancer that has brought patients to Indiana University Health in recent years for treatment, has become the subject of further study between investigators from the Krannert Cardiovascular Research Center and the Indiana University Melvin and Bren Simon Comprehensive Cancer Center at Indiana University School of Medicine, and collaborators at Regenstrief Institute.

“Everyone is born with a thymus; it serves as one of the bases for the immunologic center to fight off infections,” said Abhishek Khemka, MD, associate professor of clinical medicine and an affiliate member of the Krannert Cardiovascular Research Center at IU School of Medicine, of the thymus, which is located behind the lungs below the breastbone. “For most adults, it will disappear, it will envelop and go away; for some people, it stays there. And for an unfortunate few, it will become a tumor and can keep growing.”

Khemka explains the reason he and his colleagues were interested in studying thymic cancer is because IU Health is a referral center nationally and internationally. There is a relatively higher prevalence of thymic cancer in Japan and many patients from that region come to IU Health for a second or third opinion, he said.

“We would see some thymic cancer patients in the hospital with cardiac issues, and we were curious about the cardiac effects that they are dealing with,” Khemka said. “Our question was, how often is the heart a variable in these kinds of patients and should they be worried about downstream effects after their cancer is in remission…Most people with thymic cancer are going to survive the cancer once they’re treated.”

Results of their 17-year retroactive study were published in Frontiers last fall. Investigators compared 296 patients with pathology-confirmed confirmed thymic cancer patients to 2,960 noncancer controls. Researchers concluded that prior to cancer diagnosis, thymic cancer patients (TCPs) had a lower prevalence of hypertension, diabetes mellitus and dyslipidemia, and similar rates of obesity, tobacco uses and pre-existing cardiovascular disease compared to the controls. They were able to stratify patients into low and high risk categories for cardiovascular complications.

Researchers found that after the thymic cancer diagnosis, high-risk TCPs had an increased risk for cardiac events and patients with multiple cardiovascular risk factors receiving radiotherapy or chemotherapy had higher incidents of cardiac events.

“If you are somebody who does not have baseline risk factors, and I mean, you don’t have a history of tobacco use, high blood pressure, high cholesterol, diabetes, or you don’t have a prior history of heart disease, in terms of a heart attack, stroke or heart failure, and so forth, then your risk of having some sort of cardiac event is fairly low,” Khemka said. “If you have one or two of these risk factors, your risk goes up a little bit. But then if you’re somebody who has more than two risk factors at baseline when you’re diagnosed with thymic cancer, your risk is much higher for cardiac complications, especially when receiving radiotherapy or chemotherapy.”

Khemka said that patients with those higher risk factors are more at risk of mortality and said those are the patients they would advocate to get a baseline screening, such as an echocardiogram, and then follow them to see if they have any cardiac issues. Cardiooncologists typically consult with the oncologist about their treatment plan and take into consideration any medications that may be cardiotoxic.

“If the person has a severely reduced heart function, their ejection fraction is really low, or they have other concerning findings, we may say this person is high-risk. Therefore, maybe we don’t treat them with the standard agent and instead work with the oncologists on the best cancer therapy with the least cardiac risk,” Khemka said.

A secondary objective of their study was to see if patients who experienced loss of muscle function, called paraneoplastic syndrome, would also show an increased incidence of cardiovascular disease, and in their study, they did not, Khemka said.

With the support of Regenstrief Institute in this study, researchers were able to analyze patient outcome data of patients in Indiana and neighboring states via the Indiana Network for Patient Care. It represents the largest health information exchange nationally with more than 100 healthcare entities providing data, including hospitals, health networks and insurance providers.

“The Indiana Network for Patient Care offers a fairly comprehensive view of the health history of patients in Indiana — and is thus a great basis to conduct this type of study,” said Titus K. Schleyer, DMD, MBA, PhD, a research scientist at the Center for Biomedical Informatics at the Regenstrief Institute, professor of medicine at IU School of Medicine and Khemka’s collaborator. “Being able to put health records together from many healthcare facilities and analyze them in detail enables cutting-edge research that benefits people in Indiana and beyond.”

Other co-authors of the study included Suparna C. Clasen, MD, Patrick J. Loehrer, MD, Anna R. Roberts, Lilian Golzarri-Arroyo, Sunil S. Badve, MD, Subha V. Raman, MD and Siu L. Hui, PhD.

Internationally recognized authority on cancer research and genome organization Feng Yue, PhD, to speak April 28

Mon, 24 Feb 2025 00:00:00 Z

Yue is the 2025 Mark Brothers Award winner

Feng Yue, PhD, a renowned scientist from Northwestern University’s Feinberg School of Medicine, will speak at Indiana University School of Medicine on April 28. Open to the entire IU School of Medicine community, including faculty, trainees, learners and staff, the presentation is an opportunity to learn from one of the leading experts in the field of cancer research and genome organization.

Who is Feng Yue, PhD?

Yue is a world-renowned scientist who studies how the arrangement of DNA inside cells affects cancer. Specifically, he has made important discoveries about how the 3D structure of genetic material can influence the development of cancer. By using advanced tools like CRISPR, which allows scientists to edit genes, and machine learning, which helps analyze large amounts of data, Yue has found ways to potentially reverse the changes in cancer cells with specific drugs.

Yue is:

Founding director of the Center for Cancer Genomics at the Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Director of the Center for Advanced Molecular Analysis at Northwestern’s Institute for Augmented Intelligence in Medicine
Duane and Susan Burnham Professor of Molecular Medicine at Northwestern University Feinberg School of Medicine
Professor of Biochemistry and Molecular Genetics and Pathology at Feinberg School of Medicine

Groundbreaking discoveries

In 2012, Yue was a key contributor to a groundbreaking discovery that changed our understanding of the human genome. The team found that the genome is organized into large regions called topologically associating domains (TADs). These TADs are essential for the proper functioning of genes and their regulatory elements. Disruptions in TAD boundaries can lead to altered gene expression, which can cause developmental diseases and cancer. This discovery has been highly influential, with more than 5,700 citations, and has laid the foundation for further studies on the 3D genome in human diseases.

Impact on cancer research

Yue's research has demonstrated how changes in the 3D structure of a patient's genome can contribute to cancer development. His work has provided insights into several types of cancer, including acute myeloid leukemia, pediatric acute lymphoblastic leukemia, pediatric brain tumors and bladder cancer. By understanding these mechanisms, Yue's research has the potential to identify new therapeutic targets and improve cancer treatment.

A leader in computational biology

In addition to his work on the 3D genome, Yue is a global leader in computational biology. He and his team have developed several innovative algorithms that are widely used in the scientific community. For example, they created the first software to predict structural variations in cancer genomes using Hi-C data and developed a deep-learning algorithm for this purpose. These tools are powerful for studying cancer and identifying critical variations that could lead to new treatments.

Collaborative projects and leadership

Yue has also been a leader in multiple large-scale international collaborative projects, such as the Encyclopedia of DNA Elements (ENCODE) project, the 4D Nucleome Project (4DN) and the Impact of Genetic Variants (IGVF) consortium. He has coordinated an effort involving more than 140 scientists worldwide and has played a key role in integrating data and leading these initiatives.

Awards and recognition

Yue's innovative research and scientific leadership have earned him numerous prestigious awards. Notably, in 2019, he was nominated by the National Human Genome Research Institute to receive the Presidential Early Career Award for Scientists and Engineers, the highest honor bestowed by the United States government on early-career science and engineering professionals. This award is a testament to his accomplishments and his promise as a leading scientist.

Krannert Biennial 2023: Early Investigator Finalists

Mon, 17 Feb 2025 00:00:00 Z

Researcher Spotlight: Shing Fai Chan, PhD

Shing Fai Chan, PhD, assistant research professor of medicine at Indiana University School of Medicine and an investigator with the Ischemic Heart Disease Research Team at Krannert Cardiovascular Research Center won first place in the Early Investigator Competition at the inaugural Krannert Biennial in May 2023.

His presentation, “Hemorrhagic Myocardial Infarction Drives Lipomatous Metaplasia of Infarcted Myocardium,” described how microvascular injury following reperfusion as a stronger predictor of major adverse cardiovascular events, including chronic heart failure.

Chan began working at IU School of Medicine as a research fellow in January 2018 and joined IU Krannert in October 2021. His research focuses on the time dependent signaling cascade events that follow a heart attack or myocardial infarction (MI). He is interested in understanding the molecular and cellular pathways activated in the heart during ischemia-reperfusion injury and how these processes contribute to cardiac remodeling, repair and function over time.

Chen's research contributions to the Ischemic Heart Disease Research Team led to a better understanding about the time-dependent signaling cascade of events that follow a heart attack.

"By focusing on the molecular pathways involved in the acute and chronic phases of MI, I have helped elucidate how cellular responses such as inflammation, microRNA dysregulation, oxidative stress and mitochondrial dysfunction, drive tissue damage and repair processes in the heart," Chan said.

Early investigators recognized

Shing Fai Chan, PhD, an investigator with the Krannert Cardiovascular Research Center received 1st place honors in the Krannert Biennial Early Investigator Competition. Wesley Anderson, MD, and Asad Torabi, MD, with the Division of Cardiovascular Medicine at IU School of Medicine, received 2nd and 3rd place respectively. Other IU School of Medicine participants included Conner Earl, MD/PhD student, Gabriel Gruionu, PhD, Yuheng Huang, MS, PhD candidate, Mark R. Kauth, MD and Varun Rao, PhD. Subha Raman, MD, former division chief and director of the IU Health / IU School of Medicine Cardiovascular Institute, awarded and congratulated them at the conclusion of the competition.

3-Year Impact Report: Message from Executive Director

Mon, 10 Feb 2025 00:00:00 Z

It is a great honor to share the research success of the Krannert Cardiovascular Research Center (IU Krannert) at the Indiana University School of Medicine since we founded the center in 2021! Three years ago, we set out to expand the understanding of cardiovascular disease so we may develop novel diagnostics and therapeutics to reduce incidents of heart disease and ultimately relegate heart disease as the leading cause of death. I am happy to share that our investigators have expanded that knowledge, with new diagnostic tools and information, that will help shape and influence cardiovascular clinical care in the years ahead.

As the inaugural executive director of IU Krannert, it has been a privilege to carry on the legacy of more than 70 years of research performed by the Krannert Institute of Cardiology, in which Herman and Ellnora Krannert made possible.

In 2021, since our arrival, we ushered in a new era of a technology-driven research enterprise, where engineering, advanced imaging, omics and artificial intelligence play a significant role in the basic, translational and clinical cardiovascular research. We added more than 30 faculty members across multiple disciplines, including cardioinformatics, cardiopulmonary research, equity research, electrophysiology, ischemic heart disease, microcirculation and myocardial regenerative biology, where synergistic collaboration is paramount to success.

By 2023, we increased National Institutes of Health research funding from $1.1 million annually to more than $22 million annually. We also produced more than 225 peer-reviewed publications, with 44 papers in high-impact academic journals.

In this short period, IU Krannert also achieved these significant milestones:

Revamped the cardiovascular clinical trials research program
Hosted the two-day Krannert Biennial, which brought to Indianapolis renowned cardiovascular researchers from around the world
Launched the first-in-human FDA-approved investigative clinical trial targeting ST Elevation Myocardial Infarction
Introduced the world's first classification of heart attacks based on tissue damage, which has been adopted by the Canadian Cardiovascular Society

Much of the success is due to the dedication of our investigative team, students and staff, who aspire to advance cardiovascular research and clinical care to benefit the next generation, as well as the many partners and collaborators we have located worldwide.

I invited you to explore our achievements to learn more about the innovative cardiovascular research happening here at IU School of Medicine. Our interdisciplinary team of investigators strive to develop and test novel diagnostics, pharmacological therapeutics and device-based interventions, which may one day bring transformative change in the management of cardiovascular care.

Sincerely,

Rohan Dharmakumar, PhD

Executive Director, Krannert Cardiovascular Research Center
Charles Fisch Professor of Cardiology
Director for Cardiovascular Imaging Research, Indiana Institute for Biomedical Imaging Sciences

Evaluating Patient Decisions: Dr. Schwartz's View

Mon, 25 Nov 2024 00:00:00 Z

Peter Schwartz, MD PhD, director of the IU Center for Bioethics and Professor of Medicine and Bioethics at IU School of Medicine, presented at Bioethics Grand Rounds last week. He focused on how to evaluate patient decision-making and the somewhat elusive measurement of decision quality. Find the recording of the talk here. Schwartz’s talk not only informed but also gave some philosophical questions about the epistemological nature of decision-making. The following is my summary of his talk and some of my reflections.

Schwartz began by describing the emergence of medical decision-making in light of the development of Modern Bioethics in the 1960s. As anti-paternalism sentiment emerged alongside the framework of respect for persons and autonomy, one area of major study was medical decision-making. Original models focused on a two-actor setting: the clinician, who brings technical expertise and can convey key information, and the patient, who brings values and then chooses one optimal option.

Considering the many limitations of this model, including limited time for patient visits and the complexity of the decision, work has been done to create decision aids to help physicians and patients partner in this process. The question then arises: how can we know and measure the success of these interventions? Or, as Dr. Schwartz questions, is it reasonable to think we can develop a measure to assess decision quality?

He highlights that the three main measurement types for decision quality – subjective, observational, and concordance – all have their uses and, more importantly, their limitations. For example, points may be attributed to the length of a visit and merit longer conversations. However, a good decision may be made quickly if there is a good relationship between the physician and the patient. Some scales give points for lowering the uncertainty of a decision which may be a poor measure of difficult decisions where a hard choice is not necessarily a bad choice.

He concludes that no measurement, or combination of measurement tools, of decision quality is sufficient to assess decisions. Comparable to assessing quality of life, it seems unfair to think of quality as a single entity. Rather, it may make more sense to think of buckets of quality – such as good, satisfactory, or bad – rather than attempt to quantify the quality itself.

Schwartz indicates that the focus should shift from attempting to quantify decision quality to identifying and addressing problematic decision-making. In other words, we should focus on finding problems and addressing them rather than seeking to score everything empirically. Bringing the discussion back to classical bioethics, he ends by arguing that justice cannot and should not be understood through an overall justice value. Rather, we should try to reduce conditions that contribute to injustice in decision-making.

As I reflect on his talk and think about my future career in medicine, I begin to think of how I can apply this framework from a provider standpoint. Medicine is not an objective practice no matter how often standardized exams may make it feel this way. When there is no clear best choice, when shared decision-making should shine, a physician must truly turn his or her full attention to the patient before them. Rather than serving as a repository of information alone, physicians should seek to understand patient’s values and share information in that light.

This is not an easy task to accomplish, especially considering the business-minded healthcare practices we live in. But it is what physicians owe to their patients. Just as Schwartz argues that decision quality must be understood by looking at individual conditions that contribute to injustice, physicians must train to see these barriers themselves.

This is a lofty goal and one that in many ways requires a shift in the philosophy of medicine. While this change should happen on institutional levels, individual physicians can impact value in this space in each decision they share with their patients. Check out Schwartz’s thought-provoking talk here and check back to this blog and the IU Center for Bioethics for more!

Insulin Price Controls, Who Falls Through the Gaps?

Mon, 04 Nov 2024 00:00:00 Z

In the United States 6 million people take insulin to control their type 2 diabetes.[1] In recent years, the high price of insulin has been widely covered in media. Disturbing stories of insulin rationing and patient deaths have been widely reported.[2] A Yale study from 2018 found that 1 in 4 patients with diabetes were cutting back on insulin due to cost.[3] More recently, price capping measure have been set in place to lower insulin prices and provide increased access. With these price settings measures, from federal and state regulations to company sponsored programs, it might seem that the problem of insulin affordability has been solved. But the full story is complex, suggesting that at least some patients may still face significant charges for insulin. In particular, patients on Medicare who do not have the Prescription Drug Benefit (Part D) are not protected by federal regulation and cannot benefit from the manufactured sponsored programs. The chance that a patient must pay a lot for insulin appears to vary, at least in part, by their insurance status, as described below:

Commercially Insured and Uninsured: Federal legislation to control insulin prices apply only to governmental programs, like Medicare and Medicaid (see below). For individuals with commercial insurance, price depends on the insurance company’s policies, meaning that the cost for individuals will vary. Uninsured individuals don’t have that sort of help: They must pay the price charged themselves. However, in part in response to the public outcry over price, starting with Eli Lilly & Co., and then followed by Novo Nordisk and Sanofi, insulin manufacturers began to slash prices on their insulins or provide company-sponsored savings programs.[4][5][6] For instance, Lilly limits expense on insulin to $35 per month. These company-led, voluntary steps have done a lot to address the problem of insulin affordability for the commercially insured and uninsured.

Medicare: Many people on Medicare (about 80%) have Part D, the Prescription Drug Benefit, and this is the group affected by federal limits on insulin cost: Starting with the “Part D Senior Savings Model” in 2021 and the later ratification of the insulin provision in the Inflation Reduction Act (IRA) in 2023, prices for insulin for those with Medicare Part D were capped at $35 per month.[7][8][9] While the initial model in 2021 only covered some insulins for participants on a subset of plans, the IRA’s insulin cap applied to all insulins covered under Medicare Part D.[10]

But 20% or so of people with Medicare do not have Part D, which means they are not so clearly protected.[11] Medicare Parts A and B do not cover most prescription drugs, and Part C (“Medigap”) plans vary on their coverage of insulin. So, these patients will often be uninsured for insulin and unprotected by the federal legislation. In addition, the manufacturer savings plans that help control costs for commercially insured and uninsured people explicitly do not apply. Consider the wording provided on the Lilly insulin savings card which requires confirmation that “I am NOT enrolled in a governmental program. Examples include Medicaid, Medicare, Medicare Part D, and others”.[12] An individual in this situation would not receive coverage for insulin under their plan and would additionally not be able to quality for Lilly’s savings program, which requires that patients not be enrolled in any governmental program. They would be responsible for the full price of their insulin prescription. For this population, there is no price protection as many states do not have individual legislation setting price caps and, in many ways, have lost incentive to do so after the passing of the IRA and the introduction of cost-savings plans from the three largest insulin manufactures. While it is possible that in practice individuals in this group may use manufacturer cost savings programs, if the wording were to be strictly enforced, they would not be covered.

Medicaid: Insulin pricing for Medicaid patients may be complex as well, since they are not protected by the Federal legislation, and plans are determined state by state. But it appears that most prescribed insulin products are covered by Medicaid, easing the burden on this group.[13]

In summary, people getting their insulin prescriptions covered by Medicare (Pard D and potentially a Part C plan) or Medicaid are well covered, and people with commercial insurance or those that are uninsured have prices set through company-sponsored savings plans. However there still exists an important hole, mostly for people on Medicare without drug coverage. The landscape is also unstable for those that rely on company-sponsored plans as those programs. Questions arise over the nature of these company sponsored savings plans: will they stick around forever without regulation or law requiring them to exist? While there may be internal desires for beneficence and external social and economic pressures that led to companies enacting and maintaining these programs, there is nothing stopping the companies from pulling the plug. Individuals with commercial insurance and those uninsured who are covered by these plans have no assurance that these programs will continue to exist and potentially could have their cost protections stripped away.

The gaps in coverage and lack of regulations protecting many Americans leaves questions to be answered. What needs to be done to provide protection through legislation and regulation? What should providers do for patients that fall in these holes and cannot afford newer insulins? Overall, the landscape of insulin pricing seems to boil down to this: we should remain vigilant watching who is protected, we should enjoy the progress that has been made for many Americans, and we should continue to focus on future measures to close gaps in price coverage for all.

[1] https://www.finance.senate.gov/imo/media/doc/Grassley-Wyden%20Insulin%20Report%20(FINAL%201).pdf

[2]https://rightcarealliance.org/activities/insulin/#:~:text=Micah%20rationed%20his%20insulin%20and,kicked%20in%20when%20he%20died.

[3] https://news.yale.edu/2018/12/03/one-four-patients-say-theyve-skimped-insulin-because-high-cost

[4] https://investor.lilly.com/news-releases/news-release-details/lilly-cuts-insulin-prices-70-and-caps-patient-insulin-out-pocket

[5] https://www.novonordisk.com/news-and-media/latest-news/lowering-us-list-prices-of-several-products-.html

[6] https://www.sanofi.com/en/investors/environment-social-governance/latest-news/sanofi-capping-its-insulin-to-a-35-out-of-pocket-costs-in-the-us

[7] https://www.kff.org/policy-watch/the-facts-about-the-35-insulin-copay-cap-in-medicare/

[8] https://www.cms.gov/priorities/innovation/innovation-models/part-d-savings-model

[9] https://aspe.hhs.gov/reports/insulin-affordability-ira-data-point

[10] https://www.kff.org/policy-watch/the-facts-about-the-35-insulin-copay-cap-in-medicare/

[11] https://data.cms.gov/summary-statistics-on-beneficiary-enrollment/medicare-and-medicaid-reports/medicare-monthly-enrollment

[12] https://insulinaffordability.lilly.com/?returnType=commercial#insurance

[13] https://documents.ncsl.org/wwwncsl/Health/Diabetes_mandates%E2%80%942016__14504.pdf?sv=2017-04-17&sr=b&si=DNNFileManagerPolicy&sig=9lxOuAIv8OaEPHi31HqAerkevKs6RAt4ATJ7NfOkmzM%3D

AI and Bioethics: Professor Hartsock's View

Thu, 31 Oct 2024 00:00:00 Z

Jane Hartsock, JD, MA, faculty investigator at the IU Center for Bioethics and System Director of Clinical and Organizational Ethics at IU Health, presented the first IU Bioethics Grand Rounds of the year last week on AI, a topic that has become an obsession for many of us in bioethics. Check out the recording here. It was a terrific talk, and it inspired me to write this blog post to summarize what she said and add some thoughts of my own.

Bioethics has been defined since the beginning as a field that thinks about new technologies that have promise and peril, such as ventilators (in the 1960s), in vitro fertilization (in the 1970s), and stem cells and cloning (1990s), just to name a few. Each technology promised advances in the battle against disease and death but also carried risks and challenges to our understanding of humanity and life. AI certainly fits.

Hartsock started, like all good bioethicists, by clarifying what she was talking about: not just “Narrow AI,” like a chess computer or an EKG machine that analyzes the rhythm, which just does one thing very well, but instead about Large Language Models (LLMs) like ChatGPT that appear to some to reflect “Artificial General Intelligence,” carrying out many cognitive tasks across multiple domains. Hartsock thinks that the current LLMs do not achieve general intelligence, while I and others think they may, but we can agree that LLMs present radical new possibilities and challenges, compared to what came before.

Here are my favorite points that she made. First, even though she thinks that AI will cause more harm than good (as I do), the United States has to continue developing this technology as fast as possible, remaining a world leader, since if we don’t, others will, and there is real risk to that. Like for the industrial revolution, there’s no future in just ignoring the technology.

Second, the risk to the way we live our life is real. Any increase in efficiency, which AI may certainly deliver, is not good or bad in itself. If AI lets you get more work done each hour, you might be able to cut your work day short, giving you more time with family, friends, and hobbies. Or, you might be given more work. Given our capitalist system, all signs point to more work, same hours, not same work, less hours. That means AI may help our bosses, not us.

Finally, the threat to education and knowledge is real. Current LLMs can already write passable student papers ( “passable” in two senses: they can pass for the real thing, and will get a passing mark). This is a threat to all of us teachers, trying to figure out how to educate and evaluate students when there is an easy and available way for them to cheat and avoid learning. The papers produced by the first generation of LLMs were easy to spot since the LLMs didn’t do references well, but the latest versions of LLMs have overcome that problem and can produce references that look real but often aren’t. Often they cite something that doesn’t exist, isn’t legitimate, or doesn’t support the claim they are cited for. It takes real work to check each reference, and most readers, and even teachers and professors, won’t.

This leads to the deeper and even more worrisome problem that Hartsock raised. Once AI generates text that is false but is written believably and with fake citations, it can serve as a source for writing in the future, serving as the basis for more false claims. And these claims will look correct even to those who check the citation. Research becomes fully disconnected from reality, and “agnotology” results, undermining all knowledge and understanding.

That’s a big and world-changing danger, perhaps not quite as bad as AI taking over the world and killing all humans (see The Terminator (1984) and other movies). But it’s still extremely worrisome, at least to those of us who care about knowledge and truth, which should be everybody. Check out Hartsock’s lecture here to hear her excellent talk, and stay tuned to this blog and the IU Center for Bioethics for more on AI.

Who Deserves Ozempic? The Ethical Challenges of Weight-Loss Use

Mon, 30 Sep 2024 19:46:00 Z

There isn't enough Ozempic for everyone who wants it. People with health conditions like type 2 diabetes and severe obesity should get it before people who hope to lose a few pounds. As the new ‘miracle drug’ for weight loss, Ozempic is one of the most popular new drugs in America. This has come mostly from the media, celebrities, and TikTok influencers praising it for its short-term effects, but not from experts.

The FDA approved the top-selling GLP-1 agonist in 2017 to treat diabetes. One in eight American adults has taken a GLP-1 drug like Ozempic, and more than 15 million are currently taking one. Due to increased demand, Ozempic shortages are expected through 2024. With a large portion of Ozempic’s market consumed by people without diabetes, those seeking the drug for diabetes treatment face a new array of ethical challenges. This rise in Ozempic for weight loss highlights ongoing concerns, such as known adverse effects like low blood sugar and malnutrition, the unknown long-term health consequences, and newly developed problems, such as accessibility and economic challenges. Until the supply/demand discrepancy is solved, those with chronic diseases such as type 2 diabetes, hyperglycemia, and moderate to severe obesity, should be prioritized in receiving Ozempic.

Prescriptions

According to CNN, 1.7% of all Americans used GLP-1 drugs, which include Ozempic, Mounjaro, and Wegovy in 2023. The 40-fold increase of Americans suddenly taking these drugs came after both industry and consumers realized their potential use for weight management.

In 2018, more than 90% of Ozempic was prescribed for type 2 diabetes, down to only 58% in 2023. The increased demand from those diagnosed with obesity, and those who desire the drug for weight loss without a diagnosis has created supply issues for this drug. This particularly affects people with diabetes seeking access to this treatment, causing some to pay as much as $1600 out of pocket per month if their insurance doesn’t cover it.

In 38 of 50 U.S. markets, the rates of generic/off-label prescriptions of Ozempic have more than doubled over the past two years, which carries greater potential for adverse effects. Furthermore, the authorization rate of insurance coverage has decreased from 60% in 2022 to as low as 25%, which is predominately due to people taking the drug for weight loss — which is often not covered. With the finite supply of these drugs, we must prioritize people with diabetes and other serious health conditions. It’s unreasonable to expect the market to self-regulate at this rate; correcting supply and demand differences without government intervention.

Weight Loss and Cosmetics

For some people with diabetes, Ozempic is more effective than other medications in managing their A1C (a marker of glucose control over time) and lowering their risk of heart attack or stroke. While Ozempic has potential advantages over other standard-of-care diabetes interventions, it does not have an advantage over other standard-of-care interventions for long-term weight management. Wegovy and Zepbound are shown to have a higher weight loss percentage and are also FDA-approved for long-term use, unlike Ozempic. It is still uncertain which is most effective at preventing weight regain once people stop taking them, since none of these medications have been studied that long.

The uncertain efficacy of long-term use is often overlooked in the rapidly expanding market. Like other treatments for obesity, such as bariatric surgery, GLP-1 agonists may suffer from issues of weight regain and lifelong implementation. This raises a secondary issue of weight management for medical purposes and weight management for cosmetic purposes, or those who seek treatment without an underlying medical condition. Those seeking treatment for diabetes and/or obesity should be prioritized not only until the supply and demand issue is solved, but until the effects of cosmetic use are further studied. The short-term risks associated with obesity far outweigh the short-term risks of Ozempic. However, in cases where it is not a treatment nor preventative measure for chronic conditions (i.e. cosmetic purposes), it is uncertain whether this will do more harm than good, especially when sustaining use over a long period of time.

Long-Term Health Impacts

The health impacts of Ozempic beyond a few years are still under investigation, with no definitive results yet published. The first clinical trial studying the effects of semaglutides on obesity was in 2021, and no studies have yet been published on the effects of semaglutides on mental health or cosmetic weight loss. When patients stop taking Ozempic, evidence suggests that two-thirds of the weight lost is regained within one year. Ongoing treatment is suggested, but no one seems certain how long is too long. In the United Kingdom, Ozempic is only recommended for a maximum of 2 years “as an adjunct to a reduced calorie diet and increased physical activity.” The National Institute for Health and Care Excellence (NICE) claims this combination is the most sustainable long-term. Furthermore, long-term use of the drug extends the potential for adverse side effects that are already present in short-term use, such as gallstones, kidney disease, loss of appetite, and thyroid complications. Given this uncertainty, continuing to glorify Ozempic in the United States as a quick and easy weight loss solution is not ideal.

Counterfeiting

The supply/demand discrepancy drives even those with a medical need for Ozempic to get it from unfamiliar sources. High demand and low supply fuel counterfeit operations, with semaglutides produced from unreliable, unregulated sources and marketed through unauthorized distributors. Using techniques like fake batch numbers and relabeling insulin as Ozempic, counterfeits contain harmful ingredients, causing adverse effects not found in the real medication. The FDA has issued an official warning after the rise in reports of life-threatening adverse effects, such as hypoglycemic shock, nausea, comas, seizures, and infections. The World Health Organization (WHO) also issued an official warning of falsified Ozempic citing the risks of “incorrect dosage, contamination with harmful substances, or use of unknown or substituted ingredients.”

Consumers trust pharmacies to provide safe and effective medication. However, even legitimate pharmacies are at risk as they turn to unfamiliar distributors to meet demand. Convincing counterfeiters can sneak Ozempic replicas past the authorized supply chain. An even bigger problem lies in the “gray market”, where products are bought and sold without government oversight. Unlicensed distributors often sell counterfeit Ozempic to consumers or other distributors in this market without ever even encountering an authorized supply chain.

Counterarguments

Proponents of Ozempic argue that it nonetheless serves its intended purpose: to manage blood glucose levels and to achieve weight loss, regardless of supply/demand issues. With this, they assume that people know the short-term risks and that the existing free-market approach could make Ozempic access more feasible by increasing production to solve the supply/demand discrepancy. The production increase would make prioritization less of a problem and could at least prioritize medical interventions. However, this has yet to be seen, and the supply/demand issue still exists. How long are we going to give the market time to self-regulate? How long are we willing to let those with a need go without?

Other proponents might accept the short-term risks for cosmetic purposes and dismiss the fact that there is much unknown, including whether it is sustainable long-term. Accepting this view would also require holding the uncertainty of long-term risks as insignificant, and this is simply not the case when there is potential for harm. Moreover, this view fails to consider the effects of taking Ozempic alone without other lifestyle interventions for weight loss (i.e. diet and exercise), which would make it less of a ‘miracle drug’ than it may seem. Especially when other FDA-approved medical interventions have been deemed effective and safe for long-term use, such as liraglutide, phentermine, and several others; meanwhile, Ozempic has not. Therefore, it is not reasonable to listen to the media that is giving praise to it.

Conclusion

We must prioritize patients with clear, beneficial reasons to take GLP1s, like Ozempic. While GLP1s may become a practical treatment for obesity, clear evidence that the benefits outweigh the risks has yet to be seen. Prioritization is needed for medical intervention over cosmetic purposes. We know that one must permanently stay on Ozempic or risk regaining weight. As a new drug, we lack information on long-term health impacts, and the statistics surrounding supply, demand, and access remain concerning. That means the risk/benefit assessment is different for people with significant medical needs compared to people hoping to lose weight for its own sake. Access issues have also caused a considerable increase in counterfeit drugs, causing problems for pharmacies trying to meet the inflated demand. With what is currently known, we should ensure Ozempic is available for people who need it before access for cosmetic, non-chronic weight management use.

Morgan Rich is a graduate assistant for the Indiana University Center for Bioethics.

IU School of Medicine hosts national conference on technology in cancer research

Wed, 11 Sep 2024 00:00:00 Z

The Indiana University School of Medicine Department of Pathology and Laboratory Medicine is hosting the annual meeting of the National Institutes of Health/National Cancer Institute program for Informatics Technology for Cancer Research (ITCR). The conference will be held Sept. 16-19 in Indianapolis.

ITCR aims to promote interdisciplinary collaboration in technology development and dissemination, leveraging the expertise of IT professionals and cancer researchers throughout the nation. Representatives from 75 institutions will be in attendance, and many will share findings from their NCI-funded research projects exploring emerging technology tools for early cancer detection, risk assessment, diagnosis and treatment.

“All areas of computational cancer research are discussed in this meeting,” said IU School of Medicine’s Spyridon Bakas, PhD, who made the bid for IU to host the conference. Bakas is the director of the school’s newly launched Division of Computational Pathology and of the Research Center for Federated Learning in Medicine. He has been funded by the ITCR since 2017.

Kun Huang, PhD, chair of the Department of Biostatistics and Health Data Science at the IU School of Medicine, will open the annual meeting. Huang and Bakas are among five IU School of Medicine researchers with grants from the ITCR, including Travis Johnson, PhD; Jie Zhang, PhD; and Yong Zang, PhD.

Recently, Bakas received a $3.7 million grant for a collaborative study using artificial intelligence to improve breast cancer risk prediction. The unique AI training model benefits from a large data set from multiple institutions while protecting sensitive health data through a system known as federated learning.

Michael Feldman, MD, PhD, the Manwaring Professor and chair of the Department of Pathology and Laboratory Medicine at the IU School of Medicine, is one of three keynote speakers for the ITCR’s 2024 conference. Feldman’s professional interests revolve around the development of institutional biobanking, along with the integration of information technologies into pathology and other areas of medicine. He is a member of the IU Melvin and Bren Simon Comprehensive Cancer Center, which is co-sponsoring the annual meeting. Feldman is currently developing computer-assisted diagnostic algorithms for breast cancer and has been working in the field of digital and computational pathology for the past 25 years.

Other keynote speakers for the annual conference are Debra JH Mathews, PhD, MA, associate director for research and programs for the Johns Hopkins Berman Institute of Bioethics and a professor of genetic medicine at Johns Hopkins University School of Medicine, who will discuss regulatory affairs; and Peter Mattson, PhD, president of the board of the MLCommons Association, board member at the AI Verify Foundation and a senior staff engineer at Google, who will discuss dissemination of AI models in health care.

“I am honored to have Indiana University School of Medicine selected to host the annual meeting of the National Cancer Institute’s ITCR,” Bakas said. “There will be about 90 presentations of projects focusing on all sorts of different cancers and different domains. There are projects focusing on how to analyze molecular characteristics and projects focusing on computational pathology and computational radiology, and even on large language models, like ChatGPT, and their applications on electronic health records — every area of computational cancer research will be discussed.”

Social media use by patients with hypermobile EDS

Wed, 24 Jul 2024 20:40:00 Z

*For open access link to the full article click here

Every 6.4 seconds a new social media account is created.

Since the rise of social media in the early 2000s, access to connection online has multiplied tenfold. On the average day, we spend about 2 and a half hours scrolling through social media. And this number will likely increase as the accessibility to modern electronics expands. In many ways social media has changed the way we communicate with the world around us. A multitude of platforms allows us to research dinner recipes, connect with people across the country, sell household items, and share life updates with just the tap of a few buttons.

While media access has brought these positive outcomes and hastened the immediate availability of information, it also creates avenues for miscommunication, misinformation and escalation of hateful discourse in society today. These myriad features associated with social media use, combined with an inherently underdiagnosed disease like Ehlers-Danlos Syndrome (EDS) create a potentially overwhelming global network through which to source information. And both the good and the bad come along for the ride.

Over the last year, Dr. Tom Doyle and I worked on a team led by Dr. Colin Halverson to examine these issues. We recently published our analysis in an article entitled “Social Media Use by Patients with Hypermobile Ehlers-Danlos Syndrome.” The interviews we conducted with hypermobile EDS (hEDS) patients dive into the benefits of social media use for patients with an underdiagnosed disease and the pitfalls that accompany those same interactions. Most participants from the study agreed they enjoy time spent on social media and found that their online interactions allowed them to connect with others they felt they could relate to, and otherwise had not found that type of connection in offline life. However, many also described situations where the presence of “trolls” or others with ill-intentions began to undermine the legitimacy of symptoms related to their health condition and the necessity for lifestyle changes.

A few participants described initial interactions with a subreddit entitled r/illnessfakers, where individuals with chronic diseases are targeted as exaggerating or falsifying symptoms for increased social media attention. Some postings on the subreddit have gone so far as to accuse these individuals of having “Munchausen by Internet,” the idea that they are not chronically ill with a condition like EDS, but rather are simply shopping around for a diagnosis. Participants interviewed in our study commented on the subreddit, r/illnessfakers, stating,

“They say they’re making things up and they’re just flexible,” one participant explained, stating that the users of the subreddit go on to dox and harass these people and their families. “It’s intensely sick. I can’t think of something more troubling” (16). One interviewee noted that people targeted by this subreddit have reportedly committed suicide as a result of the influx of abuse.”

As you can imagine, this subreddit inflicts harmful allegations on those dealing with chronic illnesses. In addition, giving those with confirmed EDS symptoms or diagnoses an undeserved reputation, often spreading misinformation about the disease and misinforming followers of the subreddit about the lifestyles required by those with EDS. Our study confirmed that those with EDS can find strong communities of support online, but this is made difficult with pages geared toward criticism and judgement such as this.

On top of that, now, not only do those with EDS need to pay mind to media sources with malicious intent such as r/illnessfakers, but also those that believe they are spreading helpful information and are not thought to be inherently destructive. With the rise of online social media use and media outlets, influencer culture has also made a detrimental impact on information surrounding the EDS community, as the prevalence of “party trick” content emerges, leveraging their joint flexibility or skin stretching capabilities with the goal of gaining media attention. Those with EDS also need to worry about content that portrays the real effects of their disorder, but from an overemphasized standpoint. Participants in our study agreed that the production of these party tricks or disturbing images promoted content which produced “the most views” but also encouraged unsafe behaviors, thus misinforming impressionable users with false information on connective tissue diseases.

As previously mentioned, there is an overwhelming capacity for how social media in our current age can be utilized. In the case of chronic diseases, there are so many positive aspects one can gain from engaging with online communities, with the hope that the positives will outweigh the negatives. The majority of our participants would tell you, however, regardless of information: take it all with a grain of salt.

Samantha Vershaw is a Research Assistant for the Indiana University Center for Bioethics

Dive in to the open access article here.

On the Increase in Use of GLP-1s

Thu, 27 Jun 2024 18:04:00 Z

Ozempic is suddenly a household brand name, akin to Aleve, Advil, or Nyquil. Many people are calling Ozempic, and other drugs like it, “miracle drugs.” Ozempic and Mounjaro are part of a class of drugs called GLP-1 receptor agonists (GLP-1s for short). Ozempic was approved by the F.D.A. in 2017, while Mounjaro, Ozempic’s primary competitor, was approved in 2022. Both were approved in the U.S. by the F.D.A. to help lower blood sugar. Soon after the drugs came onto the market, they were found to be quite useful to lose weight, which led the companies to develop analogous forms of the diabetes drugs that were designed and approved for weight loss.

Ozempic’s active ingredient, semaglutide, was approved by the F.D.A. for weight loss in the form of Wegovy in 2021; and Mounjaro’s active ingredient, tirzepatide, was approved for weight loss in the form of Zepbound in 2023. Being a treatment for obesity isn’t the only discovery about these drugs that have been made since they’ve come onto the market. Scientists are finding that the drugs may be useful to treat addiction, dementia, and heart disease (CNBC). Wegovy, in May 2024, was approved by the F.D.A. for the treatment of heart disease in people with obesity (FDA). With heart disease being the leading cause of death in the U.S., and obesity as the leading cause of heart disease, these drugs bring a lot of promise to two of America’s most-pressing health problems.

The increase in use of these drugs, though, can seem alarming. Data analyzed by Epic Research showed an increase in use of these drugs by 40-fold between 2017 and 2021, estimating that 6 million Americans are now on either Ozempic or Mounjaro. CNBC, analyzing data for GLP-1 drugs (Ozempic, Wegovy, Mounjaro, Zepbound) found that 9 million prescriptions of them were written in Q4 of 2022. This means that roughly 2 - 3% of the population in the United States may now be taking one of these drugs. CNBC also reports that a study found that, now that Wegovy is approved to treat heart disease in obese patients, more than 3 million Americans on Medicare could be eligible for prescription coverage of these drugs, noting that the program’s budget could be strained as Wegovy is now covered by their Part D prescription plan.

The increase in use of GLP-1s is alarming for two reasons: (1) The first reason that the increase in use of GLP-1 drugs is concerning is their little-known long-term side effects and potentially unknown short-term side effects. The drugs’ benefits are clear, but their vast benefits could also be a double-edged sword. Due to the increase in use, science may need time to “catch up” on the side effects – as in, to determine both short-term and long-term side effects as the drugs are used for different conditions and for longer periods of time. For example, one of the first GLP-1 drugs that entered the U.S. was Victoza. Victoza was approved in 2010, but in 2013, the FDA issued a warning to consumers of “possible increased risk of pancreatitis and pre-cancerous findings of the pancreas.” But we don’t have to look at previous generations of GLP-1s so see the risk that unknown side effects have. In January 2024, the FDA announced it was evaluation reports of hair loss and suicidal thoughts in patients taking Ozempic, Mounjaro, or Wegovy. So, we have seen successful GLP-1 drugs receive warnings years after being on the market for previously unknown side effects, in both an older and newer GLP-1 drugs. We must keep these cases in mind as these drugs are adopted widely as treatments for various diseases.

(2) The second reason that the increase of use is alarming is because of effects on patients’ access to their prescribed drugs. As mentioned previously, the price and wide-spread eligibility for these drugs is causing Medicare’s Part D budget to become strained. The current price, which is partially a function of supply / demand, is putting pressure even on institutions’ abilities to keep the drugs stocked. On an individual level too, the imbalance of supply and demand of these drugs has caused concerns. CBS reports that some diabetics are having a hard time having consistent access to these drugs. The limited supplies currently experienced by patients with diabetes are not purely a function of supply and demand, but also who doctors are prescribing the drugs to.

Data analyzed by Trillian Health, and reported by CNN, shows that a third of patients on Ozempic have no history of diabetes. This means that doctors are prescribing the drug “off-label,” presumably for another condition, such as weight loss. The off-label prescription of Ozempic is up to a third, or 33%, from 16% in 2021. Many doctors may feel as though they have no choice but to prescribe Ozempic to their patients who are clamoring for semaglutide to help in their weight loss. Even if doctors wanted to write a prescription for Wegovy, they may not have been able to. Novo Nordisk, the company behind Ozempic and Wegovy, says that they are years away from catching up to the demand of their drugs, and that they have stopped producing starter doses of Wegovy altogether, as they are struggling to keep up with the current number of patients on the drug.

And patients of varying races are having different experiences in getting prescribed these drugs. According to CNN, “more than 70% of semaglutide prescriptions have gone to White patients… White people are about four times more likely than Black people to have a prescription for a semaglutide medication, despite having nearly a 40% lower prevalence of diabetes and a 17% lower prevalence of obesity.” So, White patients are receiving the vast majority of semaglutide prescriptions (Ozempic and Wegovy) by percentage, despite having a lower prevalence of both diabetes and obesity. But this has been steady since 2018. Therefore, this issue may not be related to supply and demand; but rather, the fact that not a single public insurance has covered these drugs yet. This changed significantly with the approval of Wegovy for heart disease in patients with obesity, as this allows Medicare to make patients eligible for the drug. Although Medicare can now make more than 3 million patients eligible for Wegovy, this doesn’t address the gap in coverage of Ozempic and Mounjaro for diabetic patients between private and public insurance. This gap has presumably resulted in the four times difference in prescription rates between White and Black patients.

GLP-1s are seemingly miracle drugs. They are already approved for type-2 diabetes, weight loss, and heart disease. Scientists are studying them as potential treatments for addiction and dementia. This has led to a steep increase in use and prescription of these drugs, resulting in 2-3% of Americans reportedly being on them. There are two significant issues that this increase of use has caused: (1) the risk of unknown side-effects and (2) patients’ access. Victoza, a GLP-1 drug released in 2010, had side effects discovered about it, eventually resulting in official warning from the FDA in 2013. Additionally, the FDA was “evaluating reports” of hair loss and suicidal thoughts in patients taking Ozempic, Mounjaro, or Wegovy. These types of events will continue as the drugs are on the market for longer (as long-term side effects may become known), and as the drugs are used for different conditions (as other side effects may be found). Doctors must be conscious of these facts, and patients should be educated.

The second cause for concern stemming from an increased use is patients’ access. Some diabetics are reportedly having trouble accessing their previously prescribed drugs. This is ultimately from the supply and demand discrepancy but has also been triggered by doctors prescribing Ozempic off-label at higher rates, leading to Ozempic being used for weight loss and other conditions. There is also a huge barrier for Black patients trying to access these drugs, especially as none of these drugs was covered by a public health insurance in America until recently. And as of now, Medicare may make eligible about 3 million patients which have both heart disease and obesity for Wegovy. Although this is a big step, it doesn’t address the racial gap between diabetics who are eligible for these drugs. Diabetics on public insurance currently have no access to these drugs, and under current guidance, it’s unclear when that would change.

Pierce Logan is a Graduate Assistant at the Indiana University Center for Bioethics.

The Value of the Holocaust in Medical Education

Thu, 09 May 2024 00:00:00 Z

Last month, the annual Silvers Lecture on Holocaust, Genocide, and Contemporary Bioethics hosted by the IU Center for Bioethics, was given by Stacy Gallin, DMH, founding director of the Ferencz Institute, on “The Value of the Holocaust in Medical Education.” Beforehand, I was not sure what to expect, but I assumed that she might talk about the importance of taking personal responsibility when considering moral questions. I was half right, (or half wrong), but I was completely taken by surprise by her main point.

I had expected Dr. Gallin to portray the role of physicians in Nazi Germany as people who were compelled to do evil, either by social pressure or by threat of force. But that was not the case she presented. Rather, physicians in Nazi Germany were taught to view health on a societal level rather than an individual level. This meant that people could be ostensibly healthy on an individual level, yet unhealthy for the German people. People who were unable to work, or were a drain of resources, were represented as “life unworthy of life.” This line of thinking led Nazi physicians to participate in killing disabled children and adults, then Jews, Roma, homosexuals, and others . It started in 1939 with young children who showed signs of severe developmental or physical disability. It ended in the deaths of some 11 million.

The healthcare providers in Nazi Germany were deeply complicit in the Holocaust not because they were forced to do evil but because they were convinced it was right, focusing on what they saw was best for the German people overall, the Volk. This reprioritization of the provider from individual patients to the population justified profound dehumanization and then genocide.

What I took away from this lecture is the importance of questioning authority in matters of conscience, especially when your actions impact others. Recall that in that era, Germany was a world leader in scientific advancement, and “Race Hygiene” was at the bleeding edge of medical science. This science condoned horrific acts.

This is not to say that we shouldn’t “trust science” but rather that we should seek evidence for empirical claims and always respect, value, and protect individual human life. This is a fine line to walk, but in this day and age we have the capacity to independently search for and verify information, and you do yourself and others a disservice by not questioning what you are taught and forming your own conclusions. Use your judgement, engage in conversation and most importantly, have the courage to ask questions.

Duncan leads quest to end health disparities in lung cancer

Thu, 02 Nov 2023 20:50:00 Z

When it comes to lung cancer, being Black—particularly a Black male—means increased risk. Francesca Duncan, MD, MS, is determined to end disparities in the diagnosis and treatment of lung cancer—the leading cause of cancer deaths in the United States.

“Black individuals have the highest incidence rates and mortality rates compared to any other race,” said Duncan, assistant professor of pulmonary medicine at Indiana University School of Medicine and an associate member of the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.

While 15-20% of people who develop lung cancer are not smokers, in the majority of cases, smoking is linked. Curiously, research shows that smokers in the Black population tend to smoke less over time than their white counterparts yet still have worse outcomes.

“That’s what I found really interesting,” Duncan said. “That’s what started my quest to learn more about the disparities in lung cancer.”

Her initial interest in cancer research began in during graduate school where she studied cervical cancer. Later, she received an intramural research training award where she conducted breast cancer research at the National Institutes of Health/National Cancer Institute working with a physician scientist who studied tissue samples collected directly from patients.

“I thought it was remarkable that you can go from bedside to bench and back to bedside like that,” said Duncan, who would return to this lab each summer during her medical school training at Meharry Medical College, a historically Black medical school in Nashville, Tennessee. “When I began my fellowship training in pulmonary and critical care at IU School of Medicine, I was interested in finding a way that I could merge my interests in cancer research and health disparities.”

As she developed her research niche, Duncan found a valuable mentor in Catherine Sears, MD, an extensively published physician-scientist with a focus on lung cancer. Sears’ lab at IU studies the impact of DNA damage in smoking-related lung cancers and potential therapeutic targets to repair that damage and prevent progression.

“I was thrilled when Dr. Duncan approached me during her fellowship training with an interest in studying racial disparities in lung cancer outcomes and in lung cancer screening,” Sears said. “Now a junior faculty, she is leading a team to discover the root causes for these inequities and determine if interventions within lung cancer screening programs can mitigate their impact on those traditionally underserved in medicine.”

Along with pulmonary medicine colleague Edwin Jackson, DO, MBA, Duncan secured a grant from the federally funded Primary Care Reaffirmation for Indiana Medical Education (PRIME) program designed to improve lung cancer screening through a provider educational curriculum and patient educational outreach, in hopes of increasing shared decision making surrounding lung cancer screening among patients and providers.

“Lung cancer screening only became available about 10 years ago, so it’s very new,” Duncan explained. “Less than 6% of eligible people get screening, and even less among Black individuals who carry the burden of this disease.”

Current guidelines, updated in 2021 to help screen more Black patients who tend to be younger and lighter smokers, call for screening of people ages 50-80 who have a “20-pack year smoking history” (people who smoked one pack/day for 20 years, 2 packs/day for 10 years or the equivalent) and who currently smoke or have stopped smoking within the last 15 years.

Duncan is now conducting a pilot program to educate both primary care providers and patients on the process of lung cancer screening.

“Studies have shown that if it’s your doctor talking to you about screening, you’re more likely to agree to it and follow through,” she said.

Duncan recently broadened the impact of her disparities research to include the Hispanic/Latinx community via the work of an enthusiastic learner. Mariel Luna Hinojosa, MD, a third-year resident in internal medicine, is working on patient education in the Spanish language.

For Luna, it’s personal.

“My grandpa died from lung cancer,” she said. “I don’t think anybody every brought up lung cancer screening for him. His cancer was metastatic by the time he was diagnosed.”

According to the American Lung Association’s State of Lung Cancer 2022, Black Americans and Latinx Americans with lung cancer are 15% less likely to be diagnosed early compared to white Americans. Both groups are also more likely to not receive any treatment for lung cancer and are substantially less likely to survive five years compared to white Americans.

“I want to identify all the barriers—socioeconomic factors, patient-doctor relationships and the language barrier—to understand why Latinos are less likely to be screened for lung cancer,” Luna said.

Doing research with Duncan means Luna can be part of systemic change to help more people avoid the suffering of lung cancer.

“Before I met Dr. Duncan, I knew I wanted to be a doctor that helps patients overcome health disparities, but I didn’t know I could do this at a larger scale and try to correct issues within the medical system to make big changes for a population,” Luna said.

Duncan’s work includes the emerging field of "social epigenomics," an integrative field of research focused on the identification of socio-environmental factors—like limited access to health care, growing up in poverty, educational attainment, insurance status, and radon or secondhand smoke exposure—and examines their influence on human biology.

“Social epigenomics basically is studying how social determinants of health impact genetic expression,” Duncan said. “It is looking to see how your environment influences your genes leading to the development of cancer.”

Duncan’s research in racial and ethnic disparities contributes to a larger IU-led effort called End Lung Cancer Now, an initiative spearheaded by Nasser Hanna, MD, the Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research at IU School of Medicine and a member of the IU Simon Comprehensive Cancer Center.

Hanna recently gave a “State of Lung Cancer” address that included some positive trends and plans for a new mobile lung cancer screening program.

“The good news is that the number of people in the U.S. who die from lung cancer is rapidly falling, largely due to significant reduction in cigarette consumption,” he said. “We are making gains with lung cancer screening, but the rates continue to be unacceptably low. There have been significant therapeutic advances in the treatment of lung cancer, including the incorporation of immunotherapy and targeted therapy in early-stage disease.”

While that’s the good news, Hanna said, “there remains a lot of work to do.”

Some of that work is in addressing disparities in outcomes for minoritized populations, most notably among Black men.

“Black men are more likely to get lung cancer than their white counterparts, despite a lower intensity of smoking,” Hanna said. “They are more likely to be diagnosed with late-stage disease, less likely to be offered surgery, less likely to survive, and less likely to participate in a lung cancer screening program. Black Americans are more likely to be impacted by second-hand smoke as well.”

Duncan’s research is creating a better understanding of these disparities and what can be done to eliminate them.

“Understanding the causes of racial disparities in lung cancer outcomes is critically important to narrow these differences,” Hanna said. “Dr. Duncan’s research and my research overlap in many ways. Our goals are similar—to reduce the suffering and death from lung cancer and to eliminate the gap in outcomes seen based on difference in race and ethnicity.”

Learn more about End Lung Cancer Now and its goals for prevention, screening and clinical trials in lung cancer.

Dangerous Ignorance: What Patients Don’t Understand about Pharmacogenomics

Wed, 30 Aug 2023 00:00:00 Z

Do you know what pharmacogenomics is? You might not, but you should, and all patients should. Pharmacogenomics (pronounced pharma-co-genomics), which we’ll abbreviate PGx, may well be the first type of genetic testing you will get. PGx checks for genes that interfere with the body’s response to certain medications, either reducing their effectiveness or increasing side effects. For instance, some people have a gene that stops a blood thinner called clopidogrel (or “Plavix”) from working. The result can be dangerous or even life threatening since clopidogrel is often prescribed to keep blood flowing through cardiac stents that have been recently placed. Some people have a gene that makes common pain killers like codeine or hydrocodone more potent, potentially causing an overdose at even a low starting dose. If a provider knows that their patient has one of these genes, they can prescribe other medications or adjust the dosage.

Over 250 medicines currently have PGx testing listed on their FDA-approved labeling. One study found that 63% of adults and 29% of children with pharmacy insurance coverage were prescribed medicines that were significantly affected by their genes (Liu et al. 2021) . Another study predicted that 99% of over seven million veterans had at least one genetic variant that could affect how medicines work for them. (Chanfreau-Coffinier et al. 2019).

PGx testing is not yet common in health care, though, for a number of reasons. One challenge is its price and getting insurance to pay for it, despite some evidence that PGx in the right settings could save money in the long run. Another big barrier is getting the results to providers and teaching them how to interpret the results and respond.

Another barrier is teaching patients about their test results and what they mean, so they will know which medicines they can’t take or should take differently from other people and why. Our team, led by Tom Doyle, PhD, a post-doctoral fellow at IUCB, and me just published a paper that studied, for the first time, how well patients understand the results of their own PGx testing. The paper appears online in a journal called Patient Education and Counseling and can be accessed for free here. (full citation in endnote)

Here's the story: Thanks to a program funded by the IU Precision Health Initiative, patients at IU Health who are having cardiac catheterization now get tested for the CYP2C19 gene, the one that can change the effectiveness of clopidogrel (Plavix). Providers get the results through the electronic health record, and patients are sent a brochure, letter, and wallet card telling them about the result and what it means. Our team interviewed 31 patients to assess whether they know what PGx is, that they had PGx testing, and what their results are, including what the results could mean for their future healthcare.

The bottom line is that, sadly, the patients we interviewed didn’t know much. Only 4 of the 31 (13%) recognized the term “pharmacogenomics” and were able to give an acceptable definition of it. After being told what PGx is, only 10 of the 31 (32%) knew they had undergone this sort of testing. None knew the name of the gene that was tested, but 7 (23%) knew whether the result indicated that there are some medicines that might have lower effectiveness or unusual side effects. Four additional patients (13%) had saved the letter or wallet card and looked at it to tell the interviewer what the testing had shown. While only 10 participants (32%) remembered receiving the brochure, letter, or wallet card, these patients gave these materials high ratings. At the end of the interview, many patients said they wanted their future providers to have their PGx results and wanted to understand them as well.

So, what’s the take home message? In short, healthcare professionals have to do a better job of educating patients about PGx, especially as it becomes more and more a part of everyday practice. It’s essential to get the information to providers, as some experts at IU School of Medicine are doing, using the electronic health record, and it’s essential to teach providers about PGx. PGx will only happen broadly if insurance companies to pay for it.

But it’s also essential to find ways to educate patients about what PGx is and what the results mean for their personal, individual health. Whatever systems are in place to get the information to providers, there will be times when these systems fail, and then lives are on the line, since patients could be prescribed medicines that the testing already showed will not work or could even be dangerous. This is particularly important as people move from place to place, and switch health systems, and electronic health records fail to talk to each other.

How could patients be educated better? One possibility is telling them more about PGx at the time of their testing and making sure a provider or staff member talks to them about the results afterwards. Providing a letter or wallet card, or some electronic reminder or link – such as a QR code, or something on a patient portal of the electronic health record – could also help. Even if patients do not always understand the results, they could tell their providers that they were tested and help them find the results.

I’m proud of our team for clarifying the limits of patient understanding in this area and pointing the field towards the challenge of doing better at educating patients. This is a great example of how increasing patient engagement and understanding is so important to improving care, even as it is so challenging. Our team will continue to work in this area, where improving patient understanding can save lives.

This blog was written in reference to:

Doyle TA, Schmidt KK, Halverson CME, Olivera J, Garcia A, Shugg TA, Skaar TC, Schwartz PH. Patient understanding of pharmacogenomic test results in clinical care. Patient Education and Counseling. https://doi.org/10.1016/j.pec.2023.107904 Free Access Link: https://www.sciencedirect.com/science/article/pii/S0738399123002847?dgcid=author

NaloxBoxes

Wed, 09 Aug 2023 00:00:00 Z

An odd looking box has shown up at the Campus Center at Indiana University – Purdue University, Indianapolis (IUPUI) on the first floor in the Vermont Street parking garage. It’s a 24/7 “Opioid Rescue Kit” filled with naloxone nasal spray, and seeing it should make us all ecstatic. There’s also a vending machine filled with free naloxone nasal spray bottles at the Eskenazi West 38^th St. clinic, repurposed from selling snacks, to giving away these free devices. These boxes and machines known as NaloxBoxes will save lives, help address an enormous public health problem, and could improve understanding and rational responses to drug addiction. While bioethics often focuses on debates and dilemmas, this is a case of clearly ethical action. Some people have concerns about NaloxBoxes and the attitude they reflect, which I will describe and try to address here, but let me explain why we should all embrace this approach..

In 2021 and 2022, there were more than 2,000 deaths each year from drug overdose in Indiana alone, a majority being in Marion County. This number would have been higher without naloxone, a medicine that blocks the effects of opioids and is effective in treating overdoses. Naloxone, commonly known by the brand name Narcan, is an FDA-approved medication that binds to opioid receptors to block the effects of opioids; such as heroin, morphine, or oxycodone. Naloxone can be administered through intranasal spray or injected into a muscle, vein, or under the skin. The benefit of naloxone is that it is safe to administer to a person even if they are not overdosing. However, one drawback is that it wears off 30 to 90 minutes after administration, so the life-threatening effects of an overdose can return after this time. Treating an overdose sometimes requires multiple doses of naloxone, which is why it is crucial to seek medical help immediately after administering it.

Naloxone is available through emergency medical services and in some areas through pharmacies (prescription requirements vary), local health departments, or community-based distribution programs. The cost varies depending on where, how, and which form is administered. Indiana is one of many states that have since acted in fighting the epidemic using naloxone. In 2021, Governor Eric Holcomb approved $1.3 million in funding, making it the state’s third investment in naloxone distribution since May 2020. In March 2023, the FDA approved Narcan’s nasal spray for over-the-counter use, thus no longer requiring a prescription, and capped the price at less than $50 for two doses.
These are great steps for getting naloxone out there to save lives, but access remains an immense challenge. The price is an issue: $50 seems a small amount to pay to save a life, but many individuals, including those with opioid addiction, cannot or will not put out that money. Another barrier is that this is not widely accessible; it requires going to the pharmacy to get the medicine and asking a pharmacist for it.

In May 2023 Indiana Health Centers, Inc. (IHC) made the decision to install NaloxBoxes at all their health centers and WIC locations across the state. Other organizations across Indiana are following in these footsteps. Marion County now has NaloxBox installations at Salvation Army, Indianapolis Fire Department stations, various churches, and Eskenazi Health Centers among several other locations, providing the public 24/7 access to free Narcan nasal spray. Vending machines dispensing the nasal spray in larger quantities can be found in locations such as Marion County Jail and the Eskenazi Health Center on 38th St.

These boxes and vending machines are a great step: People who use drugs or know people who do might notice a machine and pick up naloxone just in case they were to encounter an overdose. Any of us can find ourselves in a situation where we see someone having an overdose, and if we have naloxone, it can save a life. This is a case where there is innovation in getting medicine to victims that can save lives. It’s the essence of an ethical step.

Could there be any reason to resist this step? Some believe that naloxone holds the potential to encourage drug abuse in that it minimizes the consequences and risks of opioid abuse, in that when the risk of death is decreased, then risk-taking behaviors increases, such as the use of higher or more frequent doses, and/or the use of more potent drugs such as Fentanyl. Some worry about the costs of naloxone distribution, with the concern that it consumes too much of the public’s funding and attention.
Studies indicate that naloxone is cost-effective through various means of distribution, specifically intranasal naloxone -- “one-time distribution of naloxone prevented 14 additional overdose deaths per 100,000 persons, with an incremental cost-effectiveness ratio of $56,699 per quality-adjusted life year”. Despite this high return on investment, opponents of naloxone argue that the cost may still be too high. Those who still oppose the distribution of naloxone despite the cost-effectiveness suggest that “if drug users just got out of the way by dying of an overdose, we’d have less of a problem.”

Researchers and physicians that favor greater naloxone access say that these normative challenges additionally have no effect on the ethical issue at stake; “The moral component here is that a lot of people think drug use is ‘bad’ […] but we don’t deny people health care because they make bad decisions.” Many who favor naloxone distribution, including addiction specialists, claim that the opposing argument stems from an incomplete understanding of addiction.

Most importantly, they emphasize that addiction is a chronic disease, not a choice, as some might think -- and whether it’s a disease or a choice, empathy with the person who’s made the poor choice, and/or suffers from the disease, is the essence of bioethical action. If we can save lives by making naloxone widely available, and it is affordable by at least some reasonable measures, then we should do it and do it as much as possible. The distribution of NaloxBoxes is an inspiration in continuing the fight for more affordable and accessible healthcare.

Doyle Publishes in Health Affairs on Personal Experience with Decision Aids

Mon, 17 Jul 2023 00:00:00 Z

The last century of medicine has seen stunning advances in technology, clinical techniques, and the structuring of healthcare institutions. Within the last two decades alone, medicine has begun down a road of increasing sophistication by considering how therapies and treatments can be tailored to particular genetic markers, spurring on astonishing medical innovation. However, these advances and innovations come with a trade-off: these advances in medicine increase the number of difficult decisions that patients face. not so long ago, patients with cancer faced only one difficult decision—whether or not to undergo surgery to treat a solid tumor. Now, due to innovation, patients face a dizzying array of decisions. Patients with cancer can now decide whether to undergo surgery, chemotherapy, or radiation treatments. In some cases, patients might decide to undergo all three of these options or none of them. Such decisions, however, are not made easily. Often, navigating through these decisions requires careful consideration of clinical expertise, patient values, and available treatment options. Resources that help guide patients through difficult decisions become invaluable, as they help provide a factual basis from which patients can make informed decisions regarding their medical care.

I, myself, have personal experience with difficult medical decisions. At 23 years old, I was diagnosed with Hodgkin’s Lymphoma. While this cancer has a remarkably high survival rate, it required that I make a difficult treatment decision. After four rounds of chemotherapy, I was given the option of either undergoing radiation therapy or two additional rounds of chemo. Both options had their own sets of risks. Additional rounds of chemo would further expose me to the toxicity exhibited by these drugs whereas radiation would mean exposing my body to potentially cancer-inducing rays. I ultimately decided to undergo radiation, as I no longer wanted to undergo the side effects associated with chemo.

Recently, I reflected on my experience with making this decision in a Narrative Matters essay for the journal Health Affairs entitled Helping Cancer Patients Through Difficult Decisions. In this essay, I highlight the need for patients to be provided with resources when they are faced with life-altering treatment decisions like my own. Apart from the clinical expertise and opinions provided to me by my oncologists, I made my decision from a relatively uninformed point of view. As a result, I question whether the treatment decision I made was the best decision for me. In an attempt to remedy this decisional uncertainty for future patients, I highlight the need for high-quality patient decision aids to be developed and implemented in clinical care.

Patient decision aids provide patients with factual, evidence-based information regarding various treatment options and their outcomes. Additionally, these aids help patients recognize or clarify their personal values to assess which options are aligned with them. Often, these aids can assist patients and physicians engage in shared decision-making by providing patients with a resource that they can refer to when discussing treatment options with their physicians.

In the essay, I argue that the distribution of decision aids should become a standard-of-care practice in certain clinical situations. I reason that, before making decisions that could have an outsized impact on one’s future health, patients should be able to carefully consider the assorted options that are available to them. Properly designed and implemented decision aids provide patients with these options in a manner that is both factually informative and clarificatory of personal values.

Find more information about decision aids.

Neurosurgery alum reflects on robust medical education at IU

Wed, 28 Jun 2023 00:00:00 Z

Robert B. Sloan, MD, looks back on his time at Indiana University fondly.

The Indianapolis physician spent his entire higher education career at IU. He earned his bachelor’s degree at IU-Bloomington and completed his medical degree and residency at IU School of Medicine.

Sloan, who is the sole neurosurgeon at Community Hospital East, carried out the bulk of that time at IU studying medicine, specifically neurosurgery. As a resident in the Department of Neurological Surgery from 2000-2006, Sloan said he studied neurosurgery “during the perfect time.” He said he received a classical medical education in his residency, and he was taught and experienced newer technologies making their way into the field of neurosurgery at the time.

“I can do it the old school way, and I can do it the new school way,” Sloan said. “I got great training at IU.”

Studying medicine wasn’t the first choice for Sloan. He was a finance major at IU as an undergraduate student and then worked for his father’s company before making a career change to medicine. Ever since graduating from IU School of Medicine, Sloan has been practicing general neurosurgery at Community Health Network in Indianapolis.

Reminiscing on his time at IU School of Medicine, Sloan said each of the faculty physicians had their own strengths, providing him with a well-rounded education.

Paul B. Nelson, MD, the department chair at the time of Sloan’s residency, taught Sloan to treat patients conservatively: first do a thorough physical exam and determine their core issue before beginning surgery. Sloan said Nelson’s goal for patients wasn’t to immediately operate but instead get to know the patient and their problem on a deeper level to make the best decision.

“In today’s world, some people get big surgeries when they need a little surgery,” Sloan said. “It takes a lot more work to do a little surgery because you have to go through the process and find out where the exact problem is happening and make a very focused fix to it as opposed to retreating to everything that looks abnormal on the imaging.”

Sloan said the Department of Neurosurgery has a family environment for its residents. He said Nelson set the tone to not only teach neurosurgery well but to take care of and respect residents. They were encouraged to have a life outside of the hospital, Sloan said. Most residents had families and spent time together at homes and participated in hobbies.

That camaraderie of faculty, residents and staff, coupled with a robust neurosurgical education, still has a positive impact on Sloan now nearly two decades since his time at IU.

“To this day, in the back of my head when I’m looking at patients, I hear my teachers, like Dr. Scott Shapiro, Dr. Mitesh Shah and Dr. Nelson, reminding me about the core values that they taught me, and I don’t forget that,” Sloan said.

Sloan treat patients at Community Hospital East with a myriad of neurological ailments as a general neurosurgeon, and most of his practice is spent seeing patients with spinal cord issues. He continues to collaborate with the Department of Neurological Surgery by building referral relationships with IU neurosurgeons to treat patients that need more specialized care.

“It’s been a good relationship,” Sloan said. “As much as I can send down to IU, I do.”

IU otolaryngology alumna recognized with endowed lectureship

Wed, 01 Mar 2023 00:00:00 Z

Allison Royer, MD, an Evansville-based physician and Indiana University School of Medicine alumna and adjunct clinical assistant professor, will be honored with a lectureship in her name.

The Department of Otolaryngology—Head and Neck Surgery is hosting the Inaugural Allison K. Royer Women in Otolaryngology Endowed Lectureship on March 22, 2023, at IU School of Medicine in Indianapolis. It is one of the first women in otolaryngology endowed lectureships in the country.

Royer, who graduated as valedictorian from IU School of Medicine in 2009 and completed her otolaryngology—head and neck surgery residency at IU in 2014, runs Family ENT Specialists with her husband, Mark Royer, MD, MBA, who was also an otolaryngology resident at IU.

As an advocate and mentor for women in surgery, Royer, an Evansville native, was recognized for her early contributions and career achievements in medicine as an inductee into the Rotary Club of Evansville 20 Under 40 in 2020. Royer has also presented her published research at national and international conferences and consistently receives top patient satisfaction scores.

Royer said her commitment to the Department of Otolaryngology at IU School of Medicine as an adjunct clinical assistant professor at the Evansville campus is due greatly to the impactful leadership of her mentor, Richard Miyamoto, MD, professor emeritus, who served as chair from 1987-2014, and her co-resident, Jonathan Ting, MD, MS, MBA, current department chair.

“We’re so fortunate to have engaged, talented residency alumni like Drs. Mark and Allison Royer part of the IU School of Medicine Otolaryngology family,” Ting said. “Their generosity in endowing this lectureship in perpetuity will provide an opportunity for future generations of trainees and faculty to hear from national thought leaders on how we can best support the career development of female otolaryngologists and those considering careers in otolaryngology—head and neck surgery.”

The inaugural lecture in March will feature Jamie Litvack, MD, MS, faculty lead, surgical subspecialties in the Department of Medical Education and Clinical Services at Elson S. Floyd College of Medicine, and Dana Crosby, MD, MHP, chair of the Department of Otolaryngology—Head and Neck Surgery at Southern Illinois University School of Medicine.

IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.

MOVE program brightens outlook for breast cancer patients

Tue, 04 Oct 2022 00:00:00 Z

No one is ever prepared for the disruption a breast cancer diagnosis brings. Jen Hedges, a 41-year-old executive with a property management company, knew chemotherapy would be brutal. She knew she would be tired, but the extremity of her exhaustion coupled with rapid weight gain left her feeling defeated.

When her nurse navigator mentioned a new exercise therapy program for breast cancer patients at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center, she didn’t hesitate.

“The exhaustion that is experienced through the chemotherapy process is tough to combat, and I was ready for a change,” said Hedges, who describes herself as “active” before her diagnosis with Stage 3 breast cancer in May 2022. “I have a long road to go to get my body back in the best shape, but I am so glad the MOVE program is there to support me. I need the extra motivation and someone that can help me understand the ‘starting over’ process.”

The Multidisciplinary Oncology Vitality and Exercise (MOVE) Program, developed by oncologist Tarah Ballinger, MD, gives cancer patients a personalized plan for exercise and physical therapy throughout all stages of their cancer journey.

“Exercise works better than any medications to treat cancer-related fatigue,” said Ballinger, an assistant professor of clinical medicine at IU School of Medicine and the Vera Bradley Foundation Scholar in Breast Cancer Research. “It reduces the effects of cancer on both physical and mental health. It prevents the degradation of muscle that occurs during treatment, and exercise helps regulate our immune system.”

The bottom line: “Exercise is important for quality of life and survival after cancer.”

Helping survivors get stronger

For years, breast cancer patients were told to “take it easy” through surgeries, chemotherapy and radiation. Turns out, that advice was wrong. Recent studies prove exercise during cancer treatment reduces negative side effects, improves mood and accelerates healing.

“In practice seeing cancer patients, a common question is what patients can do for themselves to improve how they’re feeling,” said Ballinger, a pioneer in the emerging field of exercise oncology and a researcher at the IU Simon Comprehensive Cancer Center. “Patients wanted advice on exercise and fitness, and we didn’t have a lot of answers. It was a big gap in the care we were providing.”

Ballinger conducted a survey of cancer center patients to determine their level of awareness and desire for physical activity and exercise support.

“Most patients said they didn’t have the opportunity to discuss exercise or fitness with their care providers and weren’t given specific instructions—but they wanted to be,” Ballinger found. “Since different patients need different levels of support, it needs to be personalized. The best way to do this is precision medicine.”

The cancer center piloted the MOVE program with 30 breast cancer patients in February 2022 and later expanded it to include esophageal cancer patients before opening the program for all types of cancers.

Nearly 50 patients have acted on referrals from their oncology teams since August. One patient from a different health system transferred care specifically to gain access to the MOVE program, which is offered free to all cancer center patients, Ballinger noted.

“Our breast cancer population is particularly excited about the program,” said Danielle Halsey, MS, lead exercise physiologist with MOVE. “It’s fun to see them after one or two weeks, feeling stronger and more confident in doing daily tasks such as going up and down stairs without feeling fatigued.”

Hedges, who has gone through eight rounds of chemotherapy and is scheduled for a double mastectomy this month, completes weekly workouts directed by Halsey and does physical therapy with Bryce Showers, the cancer center’s first oncology-certified physical therapist.

“I am less tired, I have more confidence in myself, and I have the desire back to push myself to maximize in all areas to get my health in its best possible shape,” Hedges said. “I am extremely grateful this program exists.”

Breast cancer survivor Janai Mitchell, 27, completes her final chemotherapy treatment in early October and has seen Halsey and Showers for exercise and physical therapy following each round. As an athlete, Mitchell was eager to join the pilot program for MOVE and provide her feedback.

“I think it gets my mind off of what I’m going through and has taken away the fatigue I would otherwise get from the chemo,” Mitchell said. “It has helped me physically and mentally to have Bryce and Dani supporting me, telling me I’m doing great and that they’re seeing progress.”

Breast cancer patients often benefit from strengthening exercises for their chest and back muscles following surgeries, Halsey said. They also frequently deal with lymphedema, a swelling of the arm on the side where lymph nodes have been removed, and chemotherapy-induced neuropathy, which causes pain or numbness in the hands and feet.

“We used to think exercise would make lymphedema worse, but what we’ve proved is actually the opposite,” Ballinger said. “Progressive weightlifting for a year after breast surgery reduces the incidence of developing lymphedema by 75 percent.”

Halsey, who has worked in exercise oncology since her undergraduate studies, vividly recalls the moment her first breast cancer patient, two months post-mastectomy, graduated from 2-pound to 5-pound weights.

“It was the most exciting thing in the world for her,” Halsey said. “There was this switch and a new sense of confidence. It was a feeling of, ‘I can do this, I am strong, I am capable.’ That is my favorite moment—when they regain that piece of themselves.”

Along with physical side effects of treatment, breast cancer survivors often experience anxiety and depression stemming from the loss of control over their life and health, Ballinger noted.

“The MOVE program helps them feel more empowered,” she said. “We might be helping them exercise or move more or push through chemotherapy, but they’re the ones doing the work. Doing something like this helps them feel more confident and capable about what they can do. For me, that’s the biggest motivator.”

Expanding exercise oncology care

A former club boxer in college and a life-long athlete, Ballinger wears pink boxing gloves to pummel a training bag at her home—a visual reminder of her continual fight to improve the lives of her patients as they “knock out” breast cancer together.

In recent decades, cancer treatments have improved so cancer survivors are living longer. While that’s good news, it means more people are living with the adverse side effects of cancer treatments, Ballinger noted. Those who exercise have better long-term prognoses.

“Higher levels of activity after cancer diagnosis are associated with a 38-percent reduction in cancer-specific death in breast cancer,” Ballinger said. “We spend billions of dollars to develop drugs, but exercise is freely available. We need to use our resources to help patients take advantage of its benefits.”

The IU Simon Comprehensive Cancer Center is making it easy for patients to “fill” their prescription for exercise by giving them individualized exercise plans which evolve throughout the cancer journey.

The program works for every stage of cancer, from initial diagnosis all the way to metastatic disease, Ballinger said. She’s currently collecting data on the benefits of physical activity and exercise in late-stage cancer.

“The MOVE program is not just delivering a clinical service but also helping in research studies across the cancer center,” Ballinger added. “The grand vision is for this to be integrated into the plan of care for every patient who is going through cancer treatment.”

Q&A with Michele Coté, PhD

Thu, 01 Sep 2022 00:00:00 Z

Michele Coté, Ph.D., is just getting started in her new role as the second director of the Susan G. Komen Tissue Bank at IU Simon Comprehensive Cancer Center.

An internationally recognized molecular cancer epidemiologist and health disparities researcher, she began at IU on Sept. 1.

In addition to her role with the Komen Tissue Bank, Coté is the inaugural Dr. Carrie Ann Glasscock West Chair in Breast Carcinogenesis at IU Simon Comprehensive Cancer Center and a professor in the Department of Epidemiology at the IU Richard M. Fairbanks School of Public Health at IUPUI.

Dr. Coté answers questions about what brought her to IU, shares her connections with the Komen Tissue Bank, and more.

Q. What attracted you to IU?

A. My first introduction to IU, other than being a graduate of another Big Ten school, was through the Komen Tissue Bank. Most of my work in molecular epidemiology utilizes tissue, typically tumor tissue, but I immediately understood the need for normal. So, the first draw was really scientific.

After my first visit, I appreciated the fact that the IU Simon Comprehensive Cancer Center was recently awarded comprehensive status by the NCI, highlighting the fact that there are incredible clinicians and scientists with the goal of transforming cancer control and care through collaborative, translational research. I’m also very excited to be a part of the Fairbanks School of Public Health, where I can help train future epidemiologists and public health practitioners.

Q. You are a molecular epidemiologist who studies cancer and health disparities. Can you break down what that means?

A. Sure. Epidemiologists are interested in the distribution and determinants of disease in a population—who is getting cancer? How are they different from people who aren’t? As a molecular epidemiologist, I use molecular biology tools to answer these questions at a cellular level. For example, we know cancer is a disease of your DNA. What genetic differences do we see in those who get cancer compared to those who don’t? How do other factors (like the environment or behaviors) impact risk along with the DNA (genetic) differences? In all of my work, my end goal is to understand what drives health disparities in populations so that we can identify appropriate interventions and reduce the burden of cancer for all.

Q. What can you tell us about your research?

A. I have a couple of different research programs I will continue at IU. In breast cancer, I’m very interested in understanding how benign breast disease impacts risk of a subsequent cancer. There are more than a million breast biopsies done annually in the United States, and the vast majority are benign. My earlier work, and that of others before me, suggests that having a benign breast biopsy increases risk of a subsequent breast cancer. I hope to define this higher risk population of women who have had a prior benign biopsy to identify ways to identify those at highest risk, and ultimately intervene to intercept the development of cancer. The KTB aligns perfectly with this work, as most of the participants do not have breast cancer and have varying levels of risk.

I’m also focused on understanding why we are seeing increases in endometrial cancer incidence, particularly high-grade cancers with poorer survival. These cancers are more frequently diagnosed in African American women, and as a field we really have no idea why this happens. Finally, my dissertation work from nearly two decades ago was on the molecular epidemiology of lung cancer. While I’ve moved away from that area, I am engaged in work that assists people, particularly people who have had poor access to quality care, to get into evidence-based tobacco cessation and lung cancer screening programs. All of the areas I describe are challenges critical to the health of the people of Indiana.

Q. Before joining IU, you interacted with the Komen Tissue Bank. How did you become connected with the KTB?

A. My awareness of the KTB was through a wonderful colleague of mine who was the chair of the Detroit Race for the Cure at the time, and a Komen advocate. She came back from a national advocacy conference with the idea that we should hold a collection event for the tissue bank in Detroit. We traveled down to Indianapolis to meet the KTB team, and I donated tissue.

In 2016, we held the Detroit event where we recruited 189 women to donate tissue in a single day, plus hundreds of volunteers. I was the scientific lead, and she was the community lead, and we brought everyone together to host this successful event. I stayed in touch with the KTB team after that time and have even used the tissue in some of my research.

Q: What projects are you most looking forward to working on as director of the Komen Tissue Bank?

A. Right now, I’m mostly excited about gaining a deeper understanding of the ongoing scientific projects, but also thinking about ways to keep the KTB at the forefront of research for the next decade and beyond.

Q. How do you envision the Komen Tissue Bank’s next five years?

A. I expect that the KTB will continue to grow in the number of participants, will enhance follow-up and engagement of participants over time, all with the constant goal of remaining flexible and responsive to needs from the research community.

Q. What are the biggest questions in cancer research that keep you up at night?

A. The biggest questions always go back to the “Why” for me—especially with breast cancer. We know there is a genetic component, where you see breast and ovarian cancers in multiple generations, but for most women, they have little or no family history. Why them? And it goes from there, into a broader why, “Why do women of African ancestry get triple negative breast cancers more frequently than those of other ancestral groups? How can we identify those at greatest risk, and focus screening there? How can we improve life after a cancer diagnosis? It keeps going!

Q. What has surprised you about your experiences as a cancer researcher?

A. I am constantly surprised by how far we have come with respect to understanding the causes of cancer, how to detect it earlier, and how to treat it. At the same time, I’m also surprised with how far we have to go in these areas. It is a rapidly changing field, with breakthroughs monthly, and yet certain types of cancer are still difficult to treat. Once you think you have answered one question, five more appear.

Q. How has the re-location from Detroit to Indy been going?

A. The relocation has been slow but steady! It is difficult to move after two decades, but I’m confident that we will settle in soon. Michigan and Indiana are similar in many ways, which helps.

Q. What do you like to do in your spare time?

A. I have two kids, one starting high school and the other college, so most of my spare time has been taking them to and from and watching them develop into interesting young adults. I love watching Big 10 college sports, traveling to just about anywhere, going to concerts, and hot yoga. I bought a bicycle here and can’t wait to explore the Monon Trail and other off-road places. A koi pond came with my new house, so I imagine I’ll be learning how to take care of that over the next few months, especially as winter approaches.

Photo: Dr. Coté with her son, Jared, at his high school graduation and her daughter, Leah, and husband, Bob.

August 2022 Newsletter

Wed, 17 Aug 2022 00:00:00 Z

Cardiovascular Institute

One, diverse academic health enterprise where people come to receive the highest quality heart and vascular care in their community while also enabling relentless innovation that fuels better health for Indiana and beyond. Read on to learn about recent advances in realizing this vision.

Quality Heart Care: Seven IU Health Hospitals Recognized

Seven IU Health hospitals participating in the American College of Cardiology's Chest Pain - MI registry have received a platinum performance award for 2022. The recipients include IU Health Arnett, Ball Memorial, Bloomington, Methodist, North, Saxony and West hospitals. This award recognizes IU Health's commitment and success in implementing a higher standard of care for heart attack patients and signifies that each hospital has reached an aggressive goal of treating these patients to standard levels of care as outlined by the American College of Cardiology and American Heart Association clinical guidelines.

To receive the Chest Pain - MI Registry Platinum Performance Achievement Award, our IU Health hospitals have demonstrated sustained achievement in the Chest Pain - MI Registry for two consecutive years (2020 and 2021), and performed at the highest level for specific performance measures.

IU Health: IC-OS Center of Excellence Award

With the leadership of Dr. Suparna Clasen, we are pleased to announce that the International Cardio-Oncology (IC-OS) Board of Directors has awarded Indiana University Health the Center of Excellence GOLD standard for outstanding professional contributions to the field of Cardio-Oncology, valid for a 3-year period.

Methodist Hospital: Get With the Guidelines Gold Award

In June, IU Health Methodist Hospital was awarded the Get With the Guidelines - Atrial Fibrillation (AFib) Gold award for sustained excellence providing care to AFib patients over two consecutive calendar years. The award, presented by the American Heart Association, also recognizes a commitment to following leading-edge treatment guidelines, ultimately reducing stroke risk for patients.

The Get With the Guidelines - AFIB program combines expertise from the American Heart Association and American Stroke Association to provide the most up-to-date and research based guidelines for patient care. As a result, teams at the IU Health Adult Academic Health Center can provide quality care and education to patients.

Certificate of Achievement: Society for Vascular Surgery Patient Safety Organization

A total of six IU Health Hospitals received the 2021 Certificate of Achievement from the Society for Vascular Surgery Patient Safety Organization at the annual meeting in Boston, Massachusetts. They are recognized for their performance at the 3 star level in the Vascular Quality Initiative (VQI) for being committed to improving care and fostering engagement with our patients!

• IU Health Bloomington Hospital
• IU Health Methodist Hospital
• IU Health Saxony Hospital
• IU Health Arnett Hospital
• IU Health West Hospital
• IU Health Ball Memorial Hospital

Patient Experience Monthly Recognition

Based upon feedback from our patients, the Cardiology MMP South clinic has earned the honor of being the IU Health Physicians Specialty Care Top Performer in patient experience for the month of April. Congratulations to Dr. Yazid Fadl and the entire team for delivering the best care and personalized approaches for every patient, every time!

Eric S. Williams, MD, Cardiovascular Fellowship

In honor of Dr. Williams decades of commitment to cardiovascular education and patient care, we are establishing the Eric. S. Williams Cardiovascular Fellowship. Watch for additional information in your email or mailbox during the month of August. Contact our Development Director, Kathryn Red, about this campaign.

Vascular Surgery Fellowship Match Results

May 11th was Fellowship Match Day for the Department of Vascular Surgery. We matched our opening and are excited to welcome Dr. Mohineesh Kumar to our fellowship training Program in 2023! Dr. Kumar earned his medical degree at Indiana University and completed his residency at William Beaumont Hospital.

Kudos

Awards

Dr. Thomas Everett and colleagues have secured a new NIH R01 grant titled: "SKNA as a Biomarker for Cardiovascular Events" based on their development of a new method to non-invasively measure sympathetic nerve activity from the skin. This research program proposes to determine if the nerve activity within the SKNA recordings can be used as a prognostic biomarker for neurological status during targeted temperature management for cardiac arrest and to risk stratify patients for recurrence of atrial fibrillation after ablation therapy.

Prostate cancer is often treated with androgen deprivation therapy which has potent side effects, one of which is atherosclerosis plaque deposition in coronary arteries and increased likelihood of heart attacks. Coronary CT with contrast (CCTA) can identify arteries affected by plaque deposition. Dr. Balaji Tamarappoo and his team have partnered with Dr. Nabil Adra and his team of GU oncologists at IUSCC to learn how androgen deprivation affects coronary artery plaque using CCTA. In this newly funded proposal by the Pfizer Myovant National Comprehensive Cancer Network (NCCN) titled, "Personalized medical treatment of coronary atherosclerosis in prostate cancer patients guided by plaque assessment with quantitative coronary CT angiography", they will use advanced computer techniques to measure the amount of coronary artery plaque from CCTA in prostate cancer patients before they begin androgen deprivation therapy. These patients will undergo a follow-up CCTA exam at 1 year which will be analyzed for changes in both the amount of plaque and high-risk plaque features. This will be the first study to directly monitor how androgen deprivation alters coronary artery plaque and will provide information on whether CCTA should be performed in more men with prostate cancer before they begin treatment with these medications.

In the Media

Dr. Khadijah Breathett was quoted in the Forbes' article titled: "Bob Harper's Simple Advice: Know CPR, Save A Life"

The Congenital heart team, including Dr. Stephen Cook, offers patient surgical bridge to transplant in this story featured on the IU Health Facebook page.

Presentations

IU Health had great representation at this year's Society of Vascular Surgery's 2022 annual meeting held in Boston, Massachusetts!

• Lillian Camino and Dr. Raghu Motaganahalli received the Winner of Best Poster for their presentation titled: "Use of VQI Registry to Implement Appropriate Use Criteria (AUC) for Atherectomy in Peripheral Vascular Interventions (PVI)".

• As President Elect, Dr. Michael Dalsing moderated the Stanley Crawford Critical Issues Forum, providing a short introduction for 7 pertinent talks that followed and then a discussion.

• During the plenary session: "Care for All - An Aspiration Goal of Merit", Dr. Andrew Gonzalez gave a talk titled: "Urban Vascular Care Deserts: Challenges and Opportunities in Our Own Backyard."

Publications

• Dr. Rolf Kreutz and team recently published in Journal of the Society for Cardiovascular Angiography an analysis of access-related clinical outcomes in 26,111 IU Health patients undergoing heart catheterization through the femoral artery. Use of a femoral artery closure device, with some differences across available devices, was associated with significantly less access site complications and bleeding events in those undergoing percutaneous coronary intervention (PCI). Kudos to IU Health interventional cardiologists reducing femoral complications with such devices while also choosing radial access first per recommendations of the IUH Coronary/Ischemic Heart Disease Quality and Clinical Effectiveness Council.

• Dr. Richard Kovacs and Dr. Asad Torabi prove that the use of standardized athlete interpretation criteria can help improve the accuracy of detecting abnormal ECGs in athletes in their recent study published in the American Heart Journal Plus.

• In this JAMA Cardiology case report, Dr. Asad Torabi, Dr. Mark Kauth and Dr. Takeki Suzuki describe a young man with syncope. Initial electrocardiogram on presentation showed type 1 Brugada ECG morphology and the diagnosis of Brugada Syndrome was made. This case highlights the importance of the recognition of the Brugada type 1 pattern as a potential cause of cardio-arrhythmogenic syncope.

Upcoming Events

THE JOAN AND DOUGLAS ZIPES VISITING PROFESSORSHIP FEATURING:

Emelia J. Benjamin, MD, ScM
Robert Dawson Evans Distinguished Professor of Medicine, Boston University School of Medicine

"Time to Double Down on Preventing Atrial Fibrillation and Its Complications"

September 27, 2022: Lecture 4:30-5:30pm
Goodman Hall Neuroscience Auditorium
362 W. 15th Street, Indianapolis, IN 46202

This will be followed by a reception and short State of the CVI update by
CVI Physician Director, Dr. Subha Raman.

We hope to see you there!

Do you have a story that reflects the strength of our statewide system for cardiovascular care?
Please email OneIUCV@iu.edu so we can share with the team!

Grad Student Earns F31 Grant

Wed, 01 Jun 2022 00:00:00 Z

A PhD student in the Department of Orthopaedic Surgery earned a grant from the National Institutes of Health that will allow her to continue researching the impacts COVID-19 has on bone health.

Olatundun Awosanya earned a Ruth L. Kirschstein National Research Service (F31) Award in May. This five-year grant from the NIH aims to enhance medical research by providing funding to students from diverse backgrounds.

Awosanya has worked in the Kacena Lab since she was an undergrad at IUPUI, studying megakaryocytes, led by Melissa Kacena, PhD, the Vice Chair of Research for the Department of Orthopaedic Surgery.

Awosanya made the trip to Cape Canaveral, Florida in 2019 when the lab conducted its second spaceflight experiment. But when the lab shifted some of its work to COVID-19 research in the early months of the coronavirus pandemic, the work sparked Awosanya’s interest, and she took on key leadership roles in the project.

Awosanya’s grant funded her study on the impacts of SARS-CoV-2 infections and age on musculoskeletal health.

This work will build upon significant discoveries the Kacena Lab made related to the coronavirus.

In 2021, researchers found that SARS-CoV-2 can cause quick and significant bone loss, even when infections appear to be mild.

Awosanya was assigned to work in the Kacena Lab as an undergrad after being accepted into IUPUI’s Life-Health Science Internship (LHSI) program, which annually places 75 undergraduate students in immersive experiences around the Indianapolis campus, encouraging them to explore career goals while gaining important professional skills.

As an IUPUI senior, Awosanya was named Intern of the Year by the state’s chamber of commerce for her work in the lab.

Indiana INTERNnet—a program sponsored by the Indiana Chamber of Commerce—names an Intern of the Year as part of its annual IMPACT Awards to celebrate high school and college intern successes across the state. Awosanya was nominated for the award by Kacena.

According to the NIH website, an F31 award helps “promising predoctoral students obtain individualized, mentored research training from outstanding faculty sponsors while conducting dissertation research in scientific health-related fields relevant to the missions of the participating NIH Institutes and Centers.”

“The overall goal of the NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the nation’s biomedical, behavioral, and clinical research needs,” the NIH website states.

Awosanya was awarded the grant on her first-ever grant submission.

Otolaryngology alumni continue practice of collaboration

Thu, 28 Apr 2022 00:00:00 Z

Even though their residency in the Department of Otolaryngology—Head and Neck Surgery at Indiana University School of Medicine overlapped for only a few years, Michael Harris, MD and Aaron Moberly, MD collaborate to this day—carrying on a tradition of teamwork.

The Department of Otolaryngology has a longstanding history of its residents placing into nationally recognized fellowship programs and hospitals. Most residents—about 60%—enter fellowship programs. The rest go straight to work in hospitals and private practices. And about half of the residents practice academic medicine.

After completing their residencies at IU School of Medicine, both Harris and Moberly separately matched into the neurotology/otology fellowship at The Ohio State University School of Medicine. They’ve since grown their academic medicine practices and research programs, attributing much of their success as faculty to what they learned while at IU.

"I've always appreciated the supportive nature of the Department of Otolaryngology at IU,” Moberly said. “They are really intentional about encouraging people in the direction that they want to pursue, and that’s the type of environment I want to foster as my career advances.”

Aaron Moberly, MD

Moberly spent nine years at IU School of Medicine, as both a medical student and resident in the Department of Otolaryngology.

The summer before his second year of medical school, he studied speech perception and language development in children with cochlear implants in the DeVault Otologic Research Laboratory, under the leadership of David Pisoni, PhD, distinguished professor of psychological and brain sciences at IU, and Derek Houston, PhD, who Moberly now works with at Ohio State.

“Having that initial exposure to this group of psychologists studying cochlear implant outcomes very early on in my medical training gave me some insight into the importance of the brain and how it interprets and processes information coming through a cochlear implant,” Moberly said.

This unique perspective to cochlear implant research—how the ear connects to the brain—was formative, Moberly said, to how he has investigated cochlear implant outcomes throughout his career. The “team science” conducted in the DeVault Lab between scientists and clinicians is also a model to how he approaches his ongoing research.

“It was a really good environment as a junior trainee to see how productive that was and how mutually fulfilling that appeared for both the clinician and researcher,” Moberly said.

When Moberly began his fellowship at Ohio State, he reconnected with Pisoni—who has now been a mentor of his for well over a decade—as he was starting to apply some of the research methods he learned while studying children with cochlear implants in the DeVault Lab to his current research looking into outcomes in older adult cochlear implant patients. That collaboration and research has continued to grow since he joined faculty at Ohio State in 2013 after his fellowship.

In summer 2021, Moberly received his first R01 grant from the National Institute on Deafness and Other Communication Disorders, a member of the National Institutes of Health, to support his research in speech perceptions in adults with cochlear implants. Moberly said he’s grateful to have assembled a team of other scientist co-investigators to tackle this research.

“My training as a clinician really helped set the stage for that, but it also helps to rely on the expertise of people coming from different backgrounds,” Moberly said. “There’s something about building a team project that I’m really proud of.”

Michael Harris, MD

Harris began his otolaryngology residency at IU School of Medicine in 2008. After completing his otolaryngology internship, Harris began a two-year postdoctoral research fellowship through the department’s NIH/NIDCD T32 training grant, which provided selected otolaryngology residents an opportunity to study speech recognition outcomes in children with cochlear implants in the DeVault Lab.

The training program, which ran from 1980 through 2016, was created and mentored by Pisoni and Richard Miyamoto, MD, chair of the Department of Otolaryngology from 1987 to 2014 and now professor emeritus.

“Being a part of the DeVault lab allowed me to hone my research skills and develop an understanding of the knowledge gaps in the field. It gave me a chance to meet and interact with many investigators working in different areas of cochlear implant research,” Harris said. “My time in the lab gave me a solid foundation for my career as a clinician-scientist.”

Pisoni not only taught Harris the science behind the lab, but he instilled the importance of creative collaboration with other researchers in adjacent but distinct fields of study, Harris said. This spirit was exemplified by the lab’s invited speaker series, regularly bringing in internal and external researchers with a variety of intellectual backgrounds.

“Having conversations with investigators working outside of your specific area of interest helps you see your own research challenges in a new light and consider different methodologies,” Harris said.

After his fellowship in the DeVault Lab, Harris completed his clinical training in otolaryngology, where he worked closely with the department’s neurotologists at the time—Miyamoto, Michael Fritsch, MD, Charles Yates, MD, and Rick Nelson, MD, PhD—all of whom had a big influence on his interest in the subspecialty.

After completing fellowship in neurotology/otology at Ohio State, Harris returned to his hometown, Milwaukee, Wisconsin, to join the faculty at Medical College of Wisconsin (MCW) in the Department of Otolaryngology and Communication Sciences. He primarily treats adults with hearing loss, middle ear disorders and lateral skull base tumors.

A significant component of Harris’ clinical practice is cochlear implantation, which dovetails with his research interest in surgical and patient factors that influence outcomes related to speech recognition and environmental sound perception. Additional research pursuits include the mechanisms linking hearing loss and cognitive decline and how hearing rehabilitation may affect that association.

Harris’ research has been supported externally by several foundation grants, and in 2021, he received an R21 grant from the NIH/NIDCD for his work on safety-relevant environmental sound perception in adults with hearing loss.

“The clinical and research training opportunities that I had at IU were very special and unique,” Harris said. “Several of my mentors and co-residents from IU are now close research collaborators and colleagues. I continue to benefit and grow thanks to my experiences at IU.”

April 2022 Newsletter

Thu, 28 Apr 2022 00:00:00 Z

Cardiovascular Institute

National Accreditation Secured for Adult Congenital Heart Disease Program

With the leadership of ACHD Medical Director, Stephen Cook, MD, we are pleased to announce that the Adult Congenital Heart Association (ACHA) has awarded the Indiana University Health Adult Congenital Heart Disease Program a status of an ACHA ACHD Accredited Comprehensive Care Center, valid for a 5-year period. Already, this program is impacting the lives of many patients in Indiana and Beyond with ACHD, many of whom require cardiac surgery in adulthood to maintain healthy, active lives.

Blake Dye Announces His Retirement

After 43 years of exceptional service in healthcare, Blake Dye, Senior Vice President for System Administration, has announced his retirement effective July 1, 2022. From the time he joined IU Health in 2018, his leadership and vision have been instrumental in the development and growth of the Cardiovascular Institute, including the successful implementation of the Heart Attack Prevention Program. He is deeply respected by his healthcare colleagues for his willingness to listen and to serve as a mentor and the Cardiovascular Institute is fortunate for his many contributions and rich experience. Please join us in congratulating Blake on his well-deserved retirement.

Welcome to Our Team

Please join us in welcoming Kimberly McClish, M.Ed., to the CV Institute to serve as the Director of Educational Initiatives for the Krannert Cardiovascular Research Center. She comes to us with several years of experience, most recently from the IU School of Medicine Emergency Medicine and Purdue University at West Lafayette in Electrical and Computer Engineering. Kimberly is passionate about education and will lead our development through strategic collaborations and research education programs.

Kudos

Awards

Marisa Sepulveda's, PhD, AHA Career Development application, titled "The Role of Endothelial Serine Protease 23 and Its Post-Transcriptional Inhibitor in Ischemic Cardiac Injury", has been funded with an exceptional score for 3 years beginning April 1, 2022. In this study, they seek to understand heart protection controlled by one enzyme and its inhibitor following heart attack using human blood vessel cells. This research will show how changing the levels of the enzyme and its inhibitor can prevent muscle damage after a heart attack.

Honors and Recognitions

Dr. K yle Frick was recently selected into IU School of Medicine's ASPIRE program. He will be collaborating with the Regenstrief Institute on a project aiming to improve cardiovascular care and outcomes by directly integrating cardiovascular disease specific health information exchange data into the electronic health record.

In the Media

Read the 13WTHR article to learn how Dr. Suparna Clasen helps a Carmel woman manage side effects of cancer treatments

Watch the WRTV interview to hear what Dr. Richard Kovacs had to say about how COVID-19 increases the risk of cardiovascular disease, effecting patients of all ages.

A first-of-its-kind operation using cells from the donor's immune system to help the recipient recognize the new heart as his own. Read the NBC article to learn what Dr. Khadijah Breathett had to say.

Presentations

Cheers to the OneIUCV Cardiology team that contributed to over 40 sessions at the American College of Cardiology's 71st Annual Scientific Session and Expo in Washington, DC, April 2 - 4, 2022 as presenters or panelists.

Watch Dr. Subha Raman's presentation on COVID implications on the heart at the "Roundtable Discussion: Managing Post-COVID Symptoms for Your Patients".

Dr. Suparna Clasen and Dr. Balaji Tamarappoo recently gave a joint presentation on "Cardio-Oncology at IU/IU Health: Mission Aligned Advances for 2022 and Beyond" at IU Simon Comprehensive Cancer Center's Grand Rounds.

Publications

The case report, recently published in JAMA Cardiology by Dr. Asad Torabi and Dr. Roopa Rao , highlights a rare complication and discusses management for a young woman who presented with shock from a viral infection and required mechanical heart support (Impella).

CV Institute is committed to bringing high value cardiovascular care to Indiana communities. Read Dr. Subha Raman's recent editorial in European Heart Journal (IF 29.98) on how we get there, and listen to a recent European Society of Cardiology podcast by her and Dr. Balaji Tamarappoo discussing a high-value tool for CV diagnosis to guide effective management.

Exciting Career Opportunities

KCVRC has, as its charge, the interdisciplinary advancement in understanding, preventing, and treating cardiovascular diseases, translating basic discoveries to favorably impact the cardiovascular health of the people of Indiana and beyond. The Center aims to advance the capabilities of high impact programmatic teams and a pipeline of talent to establish around strong pillars and cross-cutting themes in cardiovascular science.

KCVRC Major Research Areas:
Themes: Ischemic Heart Disease l Rhythm Disorders l Heart Failure
Pillars: Imaging l Informatics l Omics

Spread the word and refer those in your network!

For academic positions: postdoctoral fellowships, research scientists, and tenured/tenure track:
At Jobs.IU.edu browse Faculty
Click on IU School of Medicine
Search on keywords cardiology cardiovascular medicine research

For staff positions: basic, translational and clinical research, finance and administration:
At Jobs.IU.edu under the header Staff Positions
Select Current Employees or External Candidates
Keywords: cardiology cardiovascular medicine research

If you do not see a posting of interest, please refer your colleagues to cardadmn@iu.edu to inquire about upcoming opportunities.

Do you have a story that reflects the strength of our statewide system for cardiovascular care?
Please email OneIUCV@iu.edu so we can share with the team!

Meet Mateusz Opyrchal, MD, PhD

Fri, 04 Feb 2022 00:00:00 Z

Mateusz Opyrchal, M.D., Ph.D., began the New Year with a new job as the inaugural Vera Bradley Foundation Scholar in Breast Cancer Discovery in the Vera Bradley Foundation Center for Breast Cancer Research at the IU Simon Comprehensive Cancer Center. He also serves as the co-program leader of the cancer center’s Experimental and Development Therapeutics research program with Xiongbin Lu, Ph.D., and director of the solid tumor Phase I program.

Dr. Opyrchal’s research focuses on novel therapeutic approaches and enhancing immune responses in triple negative breast cancer. His recruitment, made possible by Vera Bradley Foundation for Breast Cancer funding, expands IU’s leadership and knowledge base for the immunotherapy initiative with the goal of developing innovative approaches to help patients with this disease.

Dr. Opyrchal answered questions about what brought him to IU, his research, and more.

Q. What attracted you to IU?

A. I was drawn by the opportunity to build a great program to move great science being done at IU into the clinic.

Q. What can you tell us about your research?

A. I’m interested in discovering new cancer targets with an emphasis on how they affect the tumor cells directly and the microenvironment surrounding them.

Q. How do you see immunotherapy transforming the future of cancer treatment?

A. We have all seen the impact immunotherapy has had already on the treatment of many cancers. Unfortunately, most patients with solid tumors, outside of a few outliers like melanoma, receive limited or no benefit from current immunotherapy treatments. I’m hopeful that we will be able to increase the number of patients benefiting from treatments and overcome some of the resistance pathways to increase duration of response.

Q. What do you find most exciting about your cancer research?

A. I think we all start out with the big dream of curing cancer. The many years of reality have shown us how difficult it is, but I’m hopeful that my research will bring us one small step closer.

Q. What is the most rewarding part of being a physician?

A. There are many, but if I was going to highlight a few: the relationships with patients where often you learn more from them about yourself and life in general as you guide them through the disease treatments; the relationship with your colleagues is also very rewarding and allows you to continually learn; and the relationship with the mentees and seeing them grow into their roles and become successful.

Q. As you look back on your career, which cancer research advances most stand out to you?

A. I started my fellowship just as ipilimumab (an immunotherapy medication) was approved and the changes over the last 10 years have been amazing to observe. Also, the concept of personalized medicine has developed and how to concentrate on one patient at a time with their unique features.

Q. What are the biggest questions in cancer research that keep you up at night?

A. I think we are all struggling with being better at preventing and curing metastatic disease without causing undue toxicities.

Q. What do you like to do in your spare time?

A. Trying to keep my two boys out of causing trouble seems to take up a lot of time. I find myself taking up taekwondo, golf and hiking in hopes of focusing their energies somewhere else–so far with not too much success outside of sore muscles for me.

Radiologic and Imaging Sciences alumni return to campus 50 years after beginning their training

Tue, 16 Nov 2021 00:00:00 Z

When it comes to education at Indiana University School of Medicine, it’s not just the training that can last a lifetime but also the connections that students make with their peers. Recently, the Radiologic and Imaging Sciences Undergraduate Programs welcomed five alumni back to campus after nearly 50 years since their graduation from the program.

The visiting alumni included Karen Retzner, Joan Burton, Marty Perkins, Wendy Ross and Lorraine Woodard, all of whom graduated from the radiography program back in 1973. Since their graduation, the group has stayed connected through thick and thin, with many of their children growing up with one another. After their graduation, the group began an annual gathering where they reunite for a day of fun activities to commemorate their education on the IUPUI campus. As this year marks 50 years since they began their training, they decided it would be extra special to return to the program that helped establish their careers and begin their lifelong friendships.

“It was heartwarming to be a part of their visit,” mentioned Donna DeVault Clark, MPA, MA, undergraduate programs specialist. “The reminiscing and love for their profession was evident in their eyes and smiles.”

During their visit, the group connected with current students, staff and faculty, including Marti Reeser, EdD, assistant dean of Health Professions and Pre-Doctoral Programs at IU School of Medicine, who shared his congratulations with the group on celebrating their milestone.

As the visiting alumni explored the campus, they even returned to some of the same halls they walked when they were in the program themselves. They also toured other facilities where students train and uncover the latest innovations in radiology, including new equipment in the Nuclear Medicine Technology and Ultrasound labs. A highlight from the day was when the group swapped stories during a visit with current second-year students, proving though the training has changed through the years, the comradery and lasting connections gained through the program have remained the same.

“It’s encouraging to have the alumni visit and see how the campus and program have changed,” said Kellie Cranfill, MSRS, RT (R)(BD), director of the Radiologic and Imaging Sciences Undergraduate Programs. “I hope our current students can look at these remarkable women and see how they can also achieve just as much one day.”

Among the alumni who visited, three stayed in the field of radiology throughout their careers—both in hospital and outpatient work— while others also pursued careers outside of radiology. Retzner, who helped organize the event, is currently a practicing nurse in Indianapolis but kept her radiography licensing active until last year. For her, as well as the other alumni, the program helped open doors to opportunity throughout Indiana, especially in health care and continuing her education.

“With the extensive training the program offered me, I never had to search for a job. They always found me,” said Retzner.

The Radiologic and Imaging Sciences Undergraduate Programs at IU School of Medicine has grown substantially since the early 1970s. In addition to new modalities like Medical Imaging Technology, the program now trains students in multiple hospitals throughout Indianapolis and across the state. As the program continues to grow, it’s introducing more students to radiology each year, allowing them to understand the significant role radiologic technologists play in health care.

The alumni returning is a testament to the exceptional training and the comradery that the program enabled 50 years ago and continues to support to this day—building bonds on campus that can last a lifetime.

IU School of Medicine professor's mission: End Lung Cancer Now

Mon, 15 Nov 2021 00:00:00 Z

Editor's Note: Sadly, advocate Alesha Arnold passed away Feb. 5, 2023. Her legacy lives on through the work of End Lung Cancer Now.

Lung cancer has an image problem, and Nasser Hanna, MD, wants to change that.

Nearly everyone in America could tell you what the pink ribbon stands for when it pops up on store displays, product packaging and social media feeds during the month of October. But how many people know that November is Lung Cancer Awareness Month or that the white ribbon represents ending the stigma surrounding the No. 1 cancer killer?

“Lung cancer kills twice as many women every year as breast cancer,” said Hanna, the Tom and Julie Wood Family Foundation Professor of Lung Cancer Clinical Research at Indiana University School of Medicine and a member of the IU Melvin and Bren Simon Comprehensive Cancer Center Leadership Council.

He is spearheading an awareness and advocacy initiative called End Lung Cancer Now.

“We know through data on stigma that breast cancer is viewed as victimizing women. Lung cancer is viewed as, ‘You got what you deserved,’ which is beyond cruel,” he said. “No one deserves lung cancer.”

According to the National Cancer Institute, an estimated 235,760 new cases of lung cancer and 131,880 deaths are projected in the United States this year. In Indiana—as well as nationally and globally—lung cancer is the leading cause of cancer deaths in both men and women.

“Lung cancer is the big elephant in the room,” Hanna said. “It takes the lives every year of more people than breast cancer, colon cancer and prostate cancer combined.”

Indiana ranks a dismal fifth out of all 50 states for the most new cases of lung cancer in 2020. The Hoosier state has three big problems when it comes to eradicating lung cancer—a high number of smokers, low number of eligible people who get lung cancer screenings, and low participation in clinical trials for lung cancer.

With improvement in these three areas, most lung cancers could be prevented or successfully treated—now, Hanna said.

“We don’t have to discover anything new—we just need to implement what we know works,” he said.

What does a lung cancer patient look like?

When thinking of lung cancer, most people wouldn’t picture a vibrant, Black woman in her 40s who has never smoked—a registered nurse who practices a healthy lifestyle and leads her daughters’ Girl Scout troops.

“Lung cancer doesn’t discriminate. If you have lungs, you can get lung cancer,” said Alesha Arnold, RN, BSN, CCRP, a clinical research nurse in breast oncology at the IU Simon Comprehensive Cancer Center who has Stage 4 lung cancer.

About 20 percent of women and 7 percent of men who develop lung cancer have never smoked.

For Arnold, breast cancer—not lung cancer—had long been of personal concern. Not only is she a breast cancer research nurse, but her mother died of breast cancer at age 51. Arnold knew the importance of doing breast self-exams and getting screening mammograms.

She was shocked by her diagnosis with advanced lung cancer in 2019 at age 44.

For several years, Arnold had a persistent cough. She and her primary care physician had been down the path of ruling out allergies and acid reflux. Then she developed back pain. A new doctor ordered some tests including a CT scan. It came back with an abnormality that turned out to be lung cancer.

Arnold knew her grandfather had died of lung cancer, but he was much older and had been a smoker. After her diagnosis, she learned other relatives had also been diagnosed with lung cancer.

“I discovered I had a genetic mutation that was germline which predisposed me to getting lung cancer,” Arnold said.

Making white ribbons to raise awareness

When people find out Arnold has lung cancer, their typical response is, “But you didn’t smoke, did you?”

Arnold is fighting the stigma and growing lung cancer awareness as an advocate with End Lung Cancer Now and a grassroots movement called the White Ribbon Project, which involves making and distributing large, wooden ribbons. These white ribbons are used to build a sense of community, promote awareness, tackle misconceptions about lung cancer, and promote messages of support, hope and empowerment.

“We have brought the white ribbon project to Indianapolis and want people to be able to identify the lung cancer ribbon and know some of the statistics—that lung cancer is prevalent and anyone can get it,” Arnold said.

Elyse Turula has joined the effort, using the tools left behind in her garage by her master carpenter husband, Harry, who died of lung cancer in 2017. To date, Turula has cut and sanded more than 100 ribbons, often using a shiny, metal Craftsman jigsaw that’s been in Harry’s family for about 60 years.

“I hear his voice when I’m working: ‘Measure twice, cut once. Always know where your cord is—and where your fingers are!’” she said.

As Turula was out in her garage in October painting her ribbons white, her neighbor’s mother stopped by to see what she was doing and asked, “Are you priming those to paint them pink?”

“No,” Turula explained as she began to talk about her loyal, fun-loving, hardworking husband of 27 years who died shortly after his 62nd birthday. The white ribbons would go to lung cancer patients, survivors and advocates.

Turula placed several ribbons in front of her own home on Halloween—the fourth anniversary of Harry’s passing. As trick-or-treating hours began, a man parked in front of her house and lit up a cigarette. Turula took the opportunity to compassionately strike up a conversation about lung cancer, asking him if he’d had a CT screening and directing him to resources on smoking cessation.

“It’s about changing the conversation,” Turula said. “If you want to stop smoking, there are people and programs to help you. Don’t let guilt stand in the way. Just move forward—and get a CT scan.”

Eliminating tobacco use in Indiana

Anyone over the age of 50 has lived through an era when smoking was so ingrained into American culture that it was allowed everywhere—restaurants, hotels, schools, even in hospitals and on airplanes.

Today in Indiana, about one out of every five adults smokes, ranking the state 10th in the nation for smoking. That’s not a Top 10 list anyone wants to be on.

“We have to drive down smoking rates, and we know that will result in less suffering and death from cancer, cardiovascular disease, strokes and COPD,” Hanna said. “We have to put gasoline on existing evidence-based programs we know work for smoking cessation. That will have a marked effect on lung cancer.”

The Indiana Tobacco Quitline is a free resource available to all Hoosiers by calling 1-800-Quit-Now; more resources are available on the Quit Now Indiana website.

Community advocates are vital to getting the word out, especially in rural and low-income areas of the state, Hanna said.

“Rural Indiana has higher rates of smoking, higher rates of cancer, lower socioeconomic status and less access to high-quality health care and prevention services,” he said. “This is where we must go.”

Increasing lung cancer screenings to save lives

Along with educating the public, End Lung Cancer Now aims to educate primary care providers about the importance of recommending screening CTs to patients who meet risk criteria. The organization also hopes to partner with radiologists throughout the state to bring mobile CT scanners into rural communities.

“Research shows some primary care physicians are poorly educated on the importance of getting lung screening scans—they are grossly underordered,” Hanna said.

When Harry Turula developed a pain in his upper lung in 2015, his physician ordered an X-ray and said everything looked good—but failed to order a CT scan. It would be another year before a pulmonologist would order the screening, despite Harry’s family history of lung cancer and his personal smoking history.

Fewer than 10 percent of people eligible for CT lung scans get them, Hanna said. By contrast, more than 70 percent of eligible people schedule their colonoscopies and mammograms.

According to the National Cancer Institute, 57 percent of lung cancer is diagnosed at Stage 4.

“Screening scans by themselves would reduce lung cancer mortality by at least 20 percent,” Hanna said.

The U.S. Preventive Services Task Force recommends annual lung cancer screening for anyone ages 50 to 80 who has a 20 pack-year smoking history and currently smokes or has quit smoking within the past 15 years. As part of the Affordable Care Act, lung cancer screening is free for eligible patients.

Advancing research through clinical trials

The last piece of the puzzle is increasing participation in clinical research trials for lung cancer—admittedly the most challenging component, Hanna said.

Even when caught early—at Stage 1—lung cancer has a cure rate of less than 70 percent. Comparatively, Stage 1 breast and prostate cancers have close to 100 percent 10-year survival rates, Hanna said.

Yet there has been progress in treating lung cancer. Many patients diagnosed with Stage 4 lung cancer now live two years or longer—up from an average of six to 12 months just five years ago, Hanna said.

Advances are only made through clinical research to develop better therapies.

“Less than 5 percent of Hoosiers with cancer participate in a clinical trial, which means 95 percent of people with advanced cancers are not getting the better therapies of tomorrow,” Hanna said. “Every advance in cancer that you will read and hear about in the next five years is available today, but you have to participate in the clinical trial.”

End Lung Cancer Now seeks to increase enrollment in clinical trials through awareness campaigns, including dispelling myths and reducing barriers for underrepresented populations. Information about current lung cancer clinical trials is available on the End Lung Cancer Now website.

In her role as a clinical research nurse, Arnold walks patients through the process of participating in clinical trials every day. Now her work seems even more vital—and personal.

“For me, advocacy and research are really what I’m about,” Arnold said. “I’m about the advancement of finding a cure for this disease and allowing patients to live longer and healthier lives. We need to do what we can to create more options for patients, and that’s the importance of research.”

With the large number of people affected by lung cancer, Arnold sees huge potential for advocacy and fundraising. There’s no reason lung cancer couldn’t achieve the same level of support as generated by the well-known organizations dedicated to ending breast cancer, she said.

“I would love to see that same type of energy and magnitude of patients and their family members who feel like they are supported,” Arnold said. “They need to know there is a community out there for them.”

End Lung Cancer Now is generously supported by a gift for lung cancer advocacy from Lilly Oncology. For more information on the fight against lung cancer in Indiana, visit End Lung Cancer Now.

A Conversation about Fortitude by Kurt Vonnegut

Wed, 10 Nov 2021 00:00:00 Z

On Wednesday, October 13, 2021, IU Center for Bioethics, Medical Humanities and Health Studies Program at IU, and The Charles Warren Fairbanks Center for Medical Ethics hosted a reading of Kurt Vonnegut’s 1968 play, Fortitude, for the American Society for Bioethics and Humanities 2021 Annual Conference. After the reading, there was a panel that included Jane Hartsock, JD as the moderator and Dr. Elizabeth Nelson, PhD, Dr. Peter Schwartz, MD, PhD, and Dr. Lucia Wocial, PhD.

Fortitude is a play about a scientist, Dr. Frankenstein, who has created a way to keep a person alive forever, by attaching their heads to machines that run the rest of their bodily functions. He has one patient to whom he has done this to, Sylvia, and in this play, she expresses her desire to die. However, Dr. Frankenstein is determined to keep her alive, despite the concerns of her beautician, Gloria, whom wants to discuss the potential for removing Sylvia from the machines. Dr. Frankenstein refuses and Gloria brings Sylvia a gun in order to die. However, Dr. Frankenstein planned for this and Sylvia’s arms do not allow her to shoot herself, and, out of desperation, she shoots Dr. Frankenstein. Dr. Frankenstein is then attached to the machines as well, allowing him to continue to live alongside Sylvia.

Following the reading, the panelists discussed the major issues. Dr. Nelson went first, talking about the idea of self, and how much of the body one can lose and still be considered themself. Since Sylvia had lost all of her body parts, being replaced by machines as each organ failed, all she had left was her head and mind. This play raises the question of where the self lives and if it is only in the mind, or in the body as a whole. She also notes that Sylvia’s mood had been carefully been controlled by drugs, which also raises the question of if controlled substances could alter the personality to the point where the self is no longer there.

Dr. Schwartz asked the question of what exactly Dr. Frankenstein is doing wrong? He argues that bioethics is to help medicine know its limits and to stop pursuing care after a certain point, but he notes that the points that medicine normally stops at is not here in this case. Sylvia is not suffering greatly, or perhaps she does but not often, expense is not a concern because Sylvia has a great wealth, Sylvia still has her consciousness, and end of life is not inevitable. Dr. Schwartz brings up that we may want to condemn Dr. Frankenstein because Sylvia has expressed a desire to die, however she also occasionally wants to live so which one is the authentic desire? There is no actual way of knowing.

Dr. Wocial spoke of the complete unwillingness of Dr. Frankenstein to dismiss any other path than the one that he has planned for Sylvia. She brings up that Dr. Frankenstein has chosen “life at all cost” and when Gloria expresses a thought that is contrary to that, he fires her. Dr. Wocial also notes the similarity in Sylvia and Gloria’s relationship to a nurse-patient relationship. She noted that the moral distress that was unaddressed in Gloria was probably the reason why she acted in a way that was inconsistent with her core values and was willing to give Sylvia the gun. Dr. Wocial stated that this was reflective of clinical practice in similar scenarios, where people may not be acting in the best interest of the patient but feel as though it is the only thing they can do.

Fortitude, while written in the 1960s and heavily influenced by the new technologies at the time, still raises a lot of issues that are relevant in today’s time. It is important to continue to ask these questions, especially with the current medical advancements that continue to extend life. Fortitude raises an important question that we all must ask: how far are we willing to go to keep someone alive?

Black patients play key role in advancing breast cancer research

Mon, 25 Oct 2021 00:00:00 Z

It’s common for people to ask friends to donate to a favorite charitable cause in lieu of birthday gifts, but Charlene Cheatham is taking it a step further. She’s asking her friends to donate their breast tissue.

Some friends have questioned why she can’t just have a birthday dinner, but Cheatham, a community advocate with Pink-4-Ever Ending Disparities, wants to help them understand how vital it is for Black women to be involved in breast cancer research.

“I tell them we’re doing this to help our families—the next generation—so if they’re diagnosed, they won’t have to suffer, or maybe there will be a cure. This is our contribution,” she said.

While white women are more likely to develop breast cancer in their lifetimes, Black women are more likely to have aggressive types of cancers that occur at a younger age—and to die from breast cancer.

These disparities were once thought to be caused by socioeconomic factors, but medical scientists have discovered genetics are also at play. Researchers at Indiana University School of Medicine are studying how treatments can be tailored for people of different ethnicities to fight breast cancer more effectively and with fewer side effects.

“The outcome in women of African ancestry is far worse than women of European ancestry—even if they have the same cancer type and even if they get the same access to care. My lab is very interested in finding out why,” said Harikrishna Nakshatri, PhD, the Marian J. Morrison Professor of Breast Cancer Research at IU School of Medicine and co-leader of the breast cancer working group at the Vera Bradley Foundation Center for Breast Cancer Research at the IU Simon Comprehensive Cancer Center.

Nakshatri is leading a project to map the breast at the single-cell level as part of the Human Cell Atlas initiative. In the more than 5,000 samples of normal breast tissue that have been donated to the Susan G. Komen Tissue Bank at the IU Simon Comprehensive Cancer Center, differences have been discovered based on the genetic ancestries of donors, Nakshatri noted.

This is why Cheatham and other community advocates are partnering with IU School of Medicine to spread the word about the importance of including Black women in clinical research for breast cancer.

Collaboration key to ending disparities

“If you don’t have high enough participation from Black women, we’re kind of left out of the research, and they don’t know how different cancer drugs affect us,” said Lisa Hayes, executive director of Pink-4-Ever Ending Disparities, an Indianapolis organization with the mission to eliminate breast cancer disparities for Black women through advocacy, education, research and empowerment.

In 2007, she and board president Nadia E. Miller were both diagnosed with triple negative breast cancer (TNBC)—an often deadly form of breast cancer that is not responsive to hormone therapies and is resistant to chemotherapy. Only recently have medical scientists discovered that African American women are more likely to carry a gene mutation which makes them at higher risk for developing TNBC—and having it recur.

“The solution to being able to eradicate disparities is to substantially focus our efforts on understanding why there are differences and then attacking the cancer more effectively,” said Bryan Schneider, MD, the Vera Bradley Professor of Oncology at IU School of Medicine.

He discovered another issue contributing to the higher mortality rate for Black breast cancer patients. Peripheral neuropathy—a common side effect of some chemotherapy drugs—causes numbness or pain in the hands, feet or limbs and disproportionately affects African American patients.

“We found, because this toxicity is so significant in our Black patient population, that it has resulted in physicians needing to reduce the dose of this curative chemotherapy, and this is one of the reasons Black patients have inferior outcomes for breast cancer—so it’s a very significant side effect to study,” Schneider said.

He is leading one of the nation’s first National Cancer Institute-funded studies exclusively focused on improving outcomes for Black breast cancer patients. The EAZ171 trial seeks to better understand and treat neuropathy induced by taxane chemotherapy drugs.

Saysha Wright was one of the early participants in the trial. A mother of two toddlers, Wright was diagnosed with Stage 2 breast cancer in July 2019. She agreed to participate in the research on neuropathy because, “Why not try to help somebody in the future?”

Wright had an acquaintance whose neuropathy became so severe that she couldn’t walk.

“I knew it could get bad,” Wright said. Thankfully, her own experiences with neuropathy were not severe, but they still impacted her everyday life.

“It was kind of hard to button up stuff and do my daughter’s hair because I lost feeling in my fingertips,” she said. “My hope is that a woman doesn’t have to experience it at all in the future. I really hope they find a cure.”

A ‘renaissance’ in breast cancer discoveries

Back in 2007, Hayes and Miller were not invited to participate in any clinical trials.

“If you look back 10-15 years ago, our advances were sluggish—we were comparing ‘chemotherapy A versus chemotherapy B’ and identifying really incremental and small benefits for a broad population,” Schneider said. “As we’re better able to embrace our own genetic diversity and its impact on the way we tolerate drugs—and how we stimulate our own immune system to attacking the tumor—these major advances in our understanding are moving us into what I think to be a renaissance period of growth in terms of cancer therapy development.”

In 2017, IU School of Medicine launched a TNBC study, led by Schneider, with the goal of discovering blood-based biomarkers to predict which patients were likely to have a recurrence of the disease. It was important to recruit Black patients to participate.

“We had marketing images with Black women in them, but they weren’t performing well on social media,” said Casey Bales, MPH, program manager for the Triple Negative Breast Cancer Precision Health Initiative and Vera Bradley Monogrammed Medicine. “We realized we needed more help.”

Schneider’s team reached out to Hayes and Miller for advice. They took a look at the existing imagery used in recruitment materials and gave their frank opinions: the pictures looked unwelcoming and “scary.”

“It was an eye-opening experience for our entire group. We sat back and tried to learn from their amazing guidance,” Schneider said.

Hayes and Miller connected the IU team with a local Black photographer, Natasha Cannon, and helped recruit breast cancer survivors to be featured in an image library that conveyed hope and courage and connected with the Black community’s values of faith and family.

As a result of this collaborative effort, 30 percent of the BRE12-158 study participants were Black—a number that is significantly higher than the national average of 5 percent participation from Black patients in clinical trials, Bales noted.

“Our partnership gave us an opportunity to create and brand materials that yielded great results. And we got new friends—it was a true collaboration,” Miller said of the relationship developed with IU School of Medicine.

Community advocates like Miller, Hayes and Cheatham share resources—and their personal stories—at community outreach events and in everyday settings like church meetings. Their efforts have helped the Komen Tissue Bank achieve a high percentage of breast tissue donations from Black women—about 17 percent. Comparatively, Indiana’s Black population is less than 10 percent.

“The message is about how their participation can really help—how important it is particularly for Black women to donate breast tissue,” Hayes said. “It’s a small sacrifice for something that can have a large impact in the future for their families.”

Now a new Phase 2 clinical trial is launching called PERSEVERE. It aims to enroll 200 participants who are at high risk for a recurrence of TNBC to study the effectiveness of personalized cancer treatment combinations based on patients’ unique genetic data. Participation from Black patients will, again, be vital.

With rapid advances in precision medicine, the medical community is figuring out what treatments work best for which people—and why. Breast cancer research is no longer a sluggish field but an energizing one, Schneider said.

“You’re going to really see massive advances as we begin to learn at a really rapid pace, and our ability to personalize medicine will be markedly better,” he said. “The drugs that are designed to attack these genetic vulnerabilities will be much sharper, much more effective, and have fewer side effects. I think we’re going to improve the cure rates for many patients.”

'Whac-a-Mole' clinical trial participant experiences remission of Stage 4 triple negative breast cancer

Tue, 19 Oct 2021 00:00:00 Z

Indiana University School of Medicine scientists continue search for life-saving treatments for aggressive types of breast cancer

Jenny Larner Brown knew she had an aggressive form of breast cancer. She had been through surgery, chemotherapy and radiation therapy—twice. At every juncture in her difficult breast cancer journey, Brown’s oncologist, Kathy Miller, MD, had been there to assure her there was a path forward for treatment.

This time was different.

“She held my hand, and it was one of those surreal moments that freeze in time,” Brown recalled. “This time there were no treatment options.”

Brown dreams of a day when no one would ever experience that kind of moment.

“I hope in five or 10 years that nobody worries about dying of breast cancer,” she said. “I would love there to be a time when the most serious breast cancer can be managed as a chronic illness—and that no one has to sit down with their oncologist and hear that they’re out of options.”

It’s now been more than two years since that terrifying moment when Brown learned her cancer was back for the third time—stage 4 of a rare, deadly combination of both triple negative and inflammatory breast cancers—and that she had an estimated 12-to-18 months to live.

Yet here she is. Taking trips with her family and friends, hiking sections of the Appalachian Trail, pursuing a master’s degree, and savoring every moment.

Because there was one option.

Brown was invited by Miller, co-leader of the breast cancer working group at the Vera Bradley Foundation Center for Breast Cancer Research, to participate in an Indiana University School of Medicine first-in-human clinical trial for women with recurrent triple negative breast cancer (TNBC). Called Whac-a-Mole after the popular arcade game, the trial aimed to test a two-drug knockout combination therapy. TNBC is tricky to treat because when one chemotherapy drug knocks out the cancer, another genetic pathway “pops up” allowing the cancer to persist, just like those pestilent moles in the game.

With all clinical trials, there are risks, and participants are made aware that they may not personally benefit but will help advance the medical community’s understanding and future treatment of the disease.

Brown and her medical team at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center certainly did not expect what happened next.

The cancer exorcism

In four years of battling cancer, Brown had never vomited from chemotherapy. But that changed during the infusion of her first dose of the experimental drug therapy in August 2019.

“It was really scary—my whole body went into shock. I was convulsing, teeth chattering, in a fog. I was in so much pain,” Brown recalled. “It felt like I had meningitis, epilepsy and hypothermia all at once—and I couldn’t stop throwing up. I truly feared I might not survive the treatment.”

She was admitted to the hospital for two days to monitor and manage symptoms. It seemed her body had rejected the drugs, so she didn’t expect much from her first follow-up ultrasound to check the effect on her tumor.

The result was indeed shocking—her tumor had vanished.

“It was a total response after one treatment,” Brown still marvels. “That first crazy hit, it was like an exorcism. And ever since, my scans have been stable. It feels like a miracle.”

Brown stayed on the trial drugs for nine months—at her own insistence—and never had another negative reaction. Today—18 months after ending all cancer drugs—she remains cancer free.

Brown’s results were a remarkable exception rather than the norm in the Whac-a-Mole clinical trial.

“What we really hope to do is understand it,” said Miller, the Ballvé Lantero Professor of Oncology at IU School of Medicine and associate director of clinical research at the IU Simon Comprehensive Cancer Center. “The better we can understand how that happened for her—what is unique about Jenny, her tumor and this therapy—the closer we get to being able to replicate it and get that response for others.”

The resurrection of everyday life

There was a time in Brown’s pre-cancer life when she might have allowed herself to be distracted when hearing the play-by-plays of her teen daughter’s school happenings. She might have worried about missing work or other obligations when helping her college-aged daughter set up her first rental house and utility bills.

Now these normal life experiences seem magnificent.

“Everything feels like a huge gift,” Brown said. “Getting this unexpected time has changed how I live and how I approach my relationships. I don’t put things off, and I try to be very present—and grateful—for the experiences I get to have.”

If the trial drugs generated a cancer exorcism, Brown is now experiencing her resurrection—reawakening to life after years of impending death.

Last summer, she enjoyed a road trip to Orlando with her daughters and hiked 33 miles of the Appalachian Trail in North Carolina with her husband, Danny. Brown aims to do the entire 2,180 or so miles of the rugged mountain trail in her lifetime—which now seems possible.

The first section of the Appalachian Trail she ever hiked was the 80-mile portion through Georgia in 2015—a year before her initial breast cancer diagnosis—and she did it solo. In the midst of her cancer treatments, she mentally drew strength from that experience, reminding herself she would make it if she just kept taking the next step forward.

“The trail teaches you so much about resilience and resourcefulness,” Brown said. “You feel every emotion, and you manage to find strength you didn’t know you had. You’ve got to keep putting one foot in front of the other. You keep breathing; you keep walking—even when it hurts.”

Now Brown is embarking on a new career in medical social work. Her aim is to become a breast cancer navigator.

“Cancer has a way of taking away power and control from you. It’s a whole new world with a whole new language—things happen really fast, and it’s overwhelming,” Brown said. “I would love to work with people newly diagnosed with breast cancer and help them understand the different parts of treatment and empower them to make informed decisions about their course of treatment.”

The testimony for clinical trials

Brown is especially passionate about alleviating patients’ reluctance to participate in clinical research. After all, she’s a walking testament to the potential benefits.

Brown recognizes the good fortune of her position at the time of her diagnosis. She was an IU School of Medicine staff member in the Office of Strategic Communications, so connecting with breast cancer experts was easy. She was aware of ongoing research into triple negative breast cancer and trusted the clinical trial designed by Miller and Milan Radovich, PhD.

The Whac-a-Mole trial was undergirded by years of research in Radovich’s lab, beginning by comparing samples of healthy breast tissue from the Susan G. Komen Tissue Bank at the IU Simon Comprehensive Cancer Center with tissue samples from breast cancer patients with TNBC. Analyzing their molecular and genetic differences was key to discovering what had gone haywire in the cancerous cells—and determining which drugs might be most effective in knocking out the cancer.

“It does really feel like a miracle to have been in exactly the right place, where this lab is looking into treatment options for the exact type of disease I have—it seems like divine intervention,” Brown said.

About 43,600 women and 530 men in the United States are expected to die from breast cancer this year, according to the American Cancer Society. Miller and other medical scientists at IU School of Medicine will continue searching for better therapies—until there is a cure.

“We’ve come a tremendous way, but we’re not done because people still die,” Miller said. “I think we’re in an incredibly encouraging and exciting time. I think we will see continued improvements in the effectiveness of the treatments we have to offer people as we learn more about the detailed breast cancer biology in all of its different forms.”

Brown donated her breast and lymph tissue so medical scientists can continue studying her outstanding outcome.

“One of my early professors, a medical geneticist, was constantly reminding us to treasure our exceptions—that’s where you have the greatest potential to learn,” Miller said. “Jenny’s response is definitely the exception. It makes me smile every time I see her.”

IU School of Medicine is soon launching a new clinical trial in triple negative breast cancer studying the effectiveness of personalized cancer treatment combinations based on patients’ unique genetic data.

“I think at IU School of Medicine, we are very fortunate to have leadership that’s passionate about creating clinically meaningful work—meaning all of our efforts, from the laboratory to translational to clinical research, are focused on making an impact on patients,” said Bryan Schneider, MD, the Vera Bradley Professor of Oncology at IU School of Medicine. “That is woven into the very fabric of how we look at things here. We have an incredible number of world-class investigators who are highly collaborative and really committed to the bigger picture of making the lives of cancer patients better.”

Giving back: One alum’s generosity means future ophthalmology professorship

Mon, 18 Oct 2021 00:00:00 Z

Arthur Willis, MD, values the education he received at the IU School of Medicine. Nearly 60 years ago, he was a budding physician who moved from his hometown in the Northeast to settle in the Midwest because he believed studying in Indiana offered him the best chances of success.

Willis graduated from Indiana University in Bloomington in 1962 and immediately enrolled at IU School of Medicine. Without the experience he gained while training at IU, Willis said he wouldn’t have been the well-rounded, quick-thinking ophthalmologist he was throughout his career.

Decades later, following his retirement, Willis decided to give back to the medical school
that helped shape him.

With assistance from the IU School of Medicine Office of Gift Development,
he has outlined plans for a legacy donation to the Department of Ophthalmology.
The funds from this generous gift will be used to create a professorship position bearing his name.

“IU was instrumental in my life,” Willis said. “I just think you should give back
to those organizations that got you to where you are.”

Willis grew up in Delaware. When he applied to attend Indiana University in Bloomington, he already had his sights set on IU School of Medicine: he thought
he’d have a better chance of being admitted to the medical school with an
undergraduate degree from the same institution.

IU School of Medicine provided excellent and wide-ranging clinical experiences—ones Willis said set him apart from his peers once he began residency.

At that time, students completed rotations in what was then Marion County General Hospital. (The facility was later renamed Wishard Memorial Hospital, and is now known as Sidney & Lois Eskenazi Hospital. IU medical students continue to train alongside faculty members at Eskenazi, which still serves as the county hospital.)

Willis completed rotations in a variety of specialties including obstetrics, internal medicine, surgery and anesthesia. These rotations came with unmatched clinical experiences.

“I delivered 20 babies as a medical student. We did spinal taps. We did liver biopsies. We did lung biopsies. You did everything there,” he said. “That experience really prepared me very well. It prepares you to make decisions and gives you a great deal of confidence.”

Completing a rotation with the ophthalmology department as a medical student is ultimately what inspired Willis to become an eye doctor.

The residents in the IU School of Medicine Department of Ophthalmology were friendly and enthusiastic about their specialty. Studying alongside them was an incredibly positive experience in Willis’s life.

After medical school, Willis went on to complete an internship at Wilmington Medical Center in his home state of Delaware. Then his training was put on hold when he joined the U.S. Air Force and served two years during the Vietnam War.

Willis was stationed in Alabama, and he took a job moonlighting as a general practitioner in a small, rural and underserved town there. There was no telling who would need his assistance or what ailments he might encounter in a day; but the wide-ranging clinical experience he gained as an IU School of Medicine medical student served him well during this time.

“It was real seat-of-the-pants medicine,” he said. “You never knew what would walk in the door.”

After leaving the Air Force, Willis completed his ophthalmology residency at the Medical College of Georgia at Augusta University. From there, he moved to Houston, Texas to complete a vitreoretinal surgery fellowship at Baylor College of Medicine.

Willis worked the majority of his career in the Houston area, preserving the sight of countless patients.

Following his retirement about 15 years ago, Willis sold several commercial properties he owned and used the money to create a charitable remainder trust. As the trust’s benefactors, he named two of the institutions that trained him: IU School of Medicine and the Medical College of Georgia.

The funds donated to IU School of Medicine will create a professorship position within the Department of Ophthalmology. Willis said he would encourage others to support IU School of Medicine financially, if they’re able.

Philanthropic gifts like Willis’s are essential to ensuring IU School of Medicine can continue to excel in its mission to train expert physicians.

Similar positions created in the Department of Ophthalmology thanks to philanthropic support include: the Letzter Professor of Ophthalmology, which was the first endowed chair in the department; the Merrill Grayson Chair in Ophthalmology, which supports vision research within the department; the Jay C. and Lucille L. Kahn Chair for Glaucoma Research and Education, and the Marilyn K. Glick Professor of Ophthalmology.

Engaging in Research with/in Rural Communities

Fri, 24 Sep 2021 00:00:00 Z

On September 17, 2021, Dr. Katharine Head, PhD, presented “Engaging in Research with/in Rural Communities” as part of the TREATs talks series by the Bioethics and Subject Advocacy Program of the Indiana CTSI . Dr. Head is an associate professor of Communication Studies at IUPUI who focuses on health and medical communication.

In “Engaging in Research with/in Rural Communities”, Dr. Head identifies four pillars that guide her research in rural communities: gatekeepers, trust, relevance, and communication. These four pillars are important to connect to the community and help solve the health disparities that exist in rural populations.

Gatekeepers act as intermediaries between researchers and participants. Gatekeepers are especially important to the project because they will help researchers gain the cooperation of participants in order to do research with the rural community rather than just in it. Gatekeepers cannot just simply be a part of the community, researchers must consider the different factors of each gatekeeper that may enhance or hinder the researcher. Dr. Head uses her research in rural Appalachia as an example, stating that while the local church could act as an intermediary since they were studying cervical cancer, the church could actually hinder their research.

Trust needs to be built especially within marginalized groups. It is important to create relationships with the community and to build rapport. There are also two different levels of trust that researchers may have, including the trust of the research institution that they are doing work with, along with the trust of individual researchers. If a research institution has a bad reputation with the rural community one is trying to enter, then it will be more difficult to build individual trust with that community.

Relevance will be essential to work with the community. If the research is not relevant to them, it could create issues with trust and what researchers’ motivations for being there are. To truly be relevant, questions and outcomes must be co-produced and research should start with reflective listening.

Communication is a critical pillar in research and must be clear, regular, and accessible. It also must be about the study purpose and methods that will be used and why they will be used. The findings and outcomes must also be communicated to the rural community that the research is about. To start communication, a lay summary would be helpful and continuing that communication during and after the research is very important.

Dr. Head states that we need to make an investment in these communities and there is more harm to just do the research and leave, with no impact on the community. She ends the talk with a quote “If you’ve visited one rural place, you’ve visited one rural place.”

You can find Dr. Head's talk here.

Ethical Challenges in AI and Other Applied Technologies

Tue, 14 Sep 2021 00:00:00 Z

On September 1, 2021, Dr. Emily Webber, MD, FAAP, FAMIA presented “Ethical Challenges in AI and Other Applied Technologies” for the Fairbanks Lecture Series in Clinical Ethics.

Dr. Webber is the Chief of Medical Information Officer for IU Health and Riley’s Children’s Health and an affiliate scientist at the Regenstrief Institute and chairperson for the American Academy for Pediatric Counsel on Clinical Information Technology. She is also a practicing pediatrician and is board certified in pediatrics, pediatric hospital medicine, and clinical informatics. Her work is currently focused on optimization of health IT, applications to improve quality care and patient safety and innovation.

In “Ethical Challenges in AI and Other Applied Technologies”, Dr. Webber emphasized the importance of asking good questions in order to recognize the potential benefits/downfalls of a certain AI program for use in healthcare. She defined the most important questions to ask as:

What is the range of intelligence of the AI?
Does it detect patterns and observe outcomes?
Did a human write all the logic rules?
Is the machine/software algorithm adjusting on its own or adjusting based on a rule its programmers provided?
Do the features of the learning model mean something to a human observer?

She also warns of some risks that come along with AI that must be considered. The first risk she identifies is bias and she states that there are multiple points for bias such as not having enough data points in a set, misapplication of resulting output and inadequate measure of accuracy. In order for medical AI to properly serve the community, the data set must be large enough to adequately cover all persons that it may be used on.

Another risk Dr. Webber identifies is the pressure to adopt and scale quickly, which, in response, we must ask if it will be likely to be used and if it will make it into the mainstream healthcare system, as many technologies do not make it that far. She also brings up the risk of public perception and about how we must consider convenience, privacy, choice, and individuality when looking at AI. There is a built-in reluctance to AI in healthcare and the public may not react well to having AI used on them.

Dr. Webber also examines case studies that the important questions can be used and what raises red flags for her in AI technology. Despite these concerns though, she claims that we shouldn’t think we should never try AI but must keep a healthy skepticism and continue to question new technologies. She advocates for a balance between innovation and discipline to regulate and ask questions, analyze the data used, and look at the skills needed, including comparing human performance to AI and determining clinical consequences of AI.

Find Dr. Webber's talk online, here .

August 2021 Newsletter

Wed, 11 Aug 2021 00:00:00 Z

We strive to be One, diverse academic health enterprise where people come to receive the highest quality heart and vascular care in their community while also enabling relentless innovation that fuels better health for Indiana and beyond. Read on to learn about recent advances in realizing this vision.

REGISTER NOW - CVI's 2nd Annual Summit on High Value Cardiovascular Care

2021 IUH/IUSM Cardiovascular Institute Summit on High Value Cardiovascular Care: Opioid-Related Valvular Heart Disease

The CV Institute is excited to announce its 2nd annual Summit on High Value Cardiovascular Care, focusing this year on Opioid-Related Valvular Heart Disease. This summit will highlight the current burden of caring for patients with valvular heart disease due to intravenous drug use. The program includes experts from cardiology, cardiac surgery, infectious disease, addiction medicine, nursing, ethics, and many more. The summit seeks to highlight solutions that clinical and community partners can use in helping Hoosiers affected by opioid-related valvular heart disease.

When: Friday, August 27, 2021

Time: Summit from 12:30pm-3:30pm

Virtual: Zoom Link: https://iu.zoom.us/s/81306425731?pwd=Z2xkVUEvNTA3dTRSclBHUlNRZGFZdz09

Pre-Register Here

Wilbert and Peggy Hamstra make $1 Million Gift to IU School of Medicine for Cardiology Research

On July 27th, a luncheon was held to celebrate the establishment of the Wilbert and Peggy Hamstra Cardiology Research Fund at Indiana University, organized by the Development Director for the Department of Medicine, Kathryn Red, and her team within the Office of Gift Development.

William Hamstra, the son of first-generation Dutch immigrants, is a native of Jasper County, Indiana, where he still lives part of the year. He was raised to believe in hard work and service to the community. He founded and operated Hamstra Builders, a home and commercial construction company that has built structures across the county. Now the Hamstra Group, the company's success provided Mr. Hamstra with the means to say thank you

"God has blessed me immensely through our business financially, and I wanted to give back," Hamstra said. "I wanted to find a way to thank all the doctors, surgeons and staff, starting with Dr. Zipes, for the years of excellent care I have received from IU Health. I think they are the best in the world."

Dr. Subha Raman welcomed the creation of The Wilbert and Peggy Hamstra Cardiology Research Fund. She said it will play a vital role in the division's future. "Mr. Hamstra's inspirational life of building with purpose will help a long line of builders at IU - people who recognize where we can do better for people affected by heart and vascular disease, and who do something about it through their work," Dr. Raman said.

Story Reported by: Bobby King and Chelsea McClellan

Welcome to our Team

Myranda Cornwell, MBA joined the Cardiovascular Institute on July 6 as the Program Manager. Myranda comes to us with great experience in Supply Chain Operations and CV. She earned her Bachelor of Science degree in May 2016 from Fairbanks School of Public Health, Indiana University Indianapolis and her Masters of Business Administration degree in December 2020 from Western Governors University. She will be managing a number of initiatives by CVI.

Ashley Gutwein, MD joined IU School of Medicine, Vascular Surgery as an Assistant Professor of Surgery on July 1. Dr. Gutwein grew up in Nebraska where she attended medical school. She completed her training here in Indianapolis with the IU Health Vascular Surgery team. Her interests are aneurysm, carotid disease, peripheral arterial disease and dialysis access. Dr. Gutwein will be primarily located at IU Health North and Arnett.

Ryan Mallory, MD joined IU Health Ball Memorial Hospital on August 2 as an interventional cardiologist. Dr. Mallory received his medical education at Ohio State University in Columbus, OH. He then completed his residency in Internal Medicine, followed by his fellowship in Cardiology and his interventional fellowship in Interventional Cardiology, at the Indiana University School of Medicine in Indianapolis, IN. He is a member of the Board of Governors for the Indiana State American College of Cardiology chapter. Dr. Mallory is board certified in internal medicine, cardiology, echocardiography and nuclear medicine.

Katsiaryna Tsarova, MD joined the Division of Cardiology in August 2021 as a non-invasive cardiologist. She earned her medical degree from the University of Florida in 2014, then completed her Internal Medicine residency at Emory University in 2017. This was followed by Cardiovascular Disease training at Indiana University during 2017-2020 and a fellowship in Advanced Cardiac Imaging in MR and CT at the University of Utah 2020-2021. Dr. Tsarova's academic interests include healthcare economics and medical education. She will be clinical based at IU Health West. Dr. Tsarova looks forward to joining the efforts to build a strong cardiac imaging program at IU Health.

Required Training

Civility and Respect Training IU Health has been working to create a healthier organizational culture, based on the IU Health Way - the organization's vision, values and promise. While team members continue to learn how best to demonstrate the values of purpose, excellence, team and compassion with patients and each other, much work remains to be done.

An ongoing learning curriculum is being developed to ensure all team members understand and know how to practice civility, inclusiveness and anti-racism. The first module, "A Civil and Respectful Workplace: Building a Strong Affirmative Culture," is available now in eLMS and must be completed by the end of this year.

Additional modules will be introduced in September, December and early next year.

*Physicians can access the module via Center for Physician Education

Access eLMS

Kudos

Honors and Recognitions

Through a rigorous peer-review process, Dr. Raghu Motaganahalli was recently selected into the prestigious Academy of Master Surgeon Educators.

Cheers to Dr. Noel Dasgupta for representing OneIUCV at the upcoming American College of Cardiology (ACC) Virtual Roundtable on Cardiac Amyloidosis: Clinical Gaps and Unmet Needs, October 25. Dr. Dasgupta is helping bring advanced treatments to help Hoosiers with this once deadly disease live longer, quality lives. Early diagnosis and treatment are key to improving survival and preventing irreversible organ damage.

Awards

Dr. Suparna Clasen has been selected for a three-year IU Health Values Research Grant entitled: Detection of late subclinical cardiovascular disease in testicular cancer survivors exposed to high-dose platinum chemotherapy and bone marrow transplant . This study prospectively looks at testicular cancer survivors (TCS) who are affected by late atherosclerotic cardiovascular disease (ASCVD) events after platinum-based chemotherapy regimens. The goal of the study is to develop effective strategies to prevent ASCVD in TCS using clinical characteristics, biomarkers, and novel imaging studies. She also just received notice of a prestigious National Institutes of Health LRP Award - congratulations, Dr. Clasen!

Dr. Gabriel Gruionu was selected as a 2021 Elevate Nexus Higher-Education recipient for his grant entitled: The Fast-In Catheter, A Novel Peripheral Intravenous Catheter for Easier Vein Access and Faster Infusion of Resuscitation Fluids in Critically Ill Cardiovascular Patients. Peripheral Intravenous Cannulation (PIVC) is the most common invasive medical procedure anywhere in the world with the purpose of collecting blood and administering nutrients and medicine to patients intravenously. Emergent PIVC, especially during resuscitation, is particularly difficult to perform in patients with small veins or in those who are critically ill or hypotensive. Dr. Gruionu's Fast-In Catheter (FIC) combines the small needle size of existing PIV catheters for less trauma and easier access to the vein, and a large bore catheter for faster resuscitation. They intend to translate this novel solution to medical practice and, in the future, develop a portfolio of a point of care applications for blood testing at bed side.

Gastric electrical stimulation has been shown to be an effective treatment of nausea and vomiting in patients with Gastroparesis, a common chronic disorder in which gastric emptying is delayed in the absence of an anatomical obstruction. It is theorized that gastric electrical stimulation improves symptoms of gastroparesis by influencing vagal outflow. Dr. Thomas Everett and his co-PIs will be investigating the mechanisms of vagal nerve activity on mediating the symptoms of nausea and vomiting, and if effecting the vagal outflow by gastric electrical stimulation also affects heart rate and cardiac function during their final year of funding for their NIH SPARC3 award. They will also be investigating the effects on Long-Haul COVID on vagal nerve activity and cardiovascular function.

Cheers to our five recent Dr. Charles Fisch Awardee recipients! The objective of this award is to support cardiovascular research for young investigators or more senior investigators, embarking on a new research direction.

• Dr. Yinan Shi - Project entitled: GALNT1 and GALNT13 as Novel O-GalNAc Glycosylation Mediators of Pulmonary Arterial Hypertension

• Dr. Suparna Clasen - Project entitled: Radiation-induced Coronary Microvascular Disease in Racially Diverse Breast Cancer Patients

• Dr. Samisubhu Naidu - Project entitled: Targeting autocrine and paracine roles of endothelial CD38 in PAH

• Dr. Gabriel Gruionu - Project entitled: The Fast-In Catheter, A Novel Peripheral Intravenous Catheter for Easier Vein Access and Faster Infusion of Resuscitation Fluids in Critically Ill Cardiovascular Patients

• Dr. Kyle Frick - Project entitled: IU Biobank and Registry of Cardiovascular Disease Associated with End-Stage Liver Disease and Cirrhotic Cardiomyopathy.

In the Media

Dr. Richard Kovacs has been fighting at the statehouse for education about sudden cardiac arrest and heart issues in student athletes. In this WRTV interview, Governor Holcomb signed a bill requiring all Indiana high schools provide educational materials about sudden cardiac arrest to all student athletes, parents and coaches.

Team Selfie of the Month

Pictured are some of our Cardiac Electrophysiology faculty members. From left to right: Dr. Mithilesh Das, Dr. Tanyana Tanawuttiwat, Dr. John Miller, Dr. Mohammed Homsi, Dr. Takeki Suzuki and Dr. Antonio Navarrete

Our EP Team is focused on a better patient experience with individualized treatment of patients with the entire array of heart rhythm disorders. The team has a total of 8 highly experienced electrophysiologist and 2 advance providers. They aim to improve access to the outpatient evaluation visits, provide hassle-free and efficient testing to arrive at correct diagnoses of rhythm problems that directly leads to personalized treatment strategies - medication, device, ablation, or observation, as appropriate. They routinely perform cardiac implantable device procedures, which include pacemakers, ICDs, biventricular ICDs, subcutaneous ICDs, his-bundle pacing, left bundle pacing and leadless pacemaker implants. Ablations are performed with no or minimum X-ray exposure. The team also performs hybrid procedures for the management of atrial fibrillation and ventricular arrhythmia.

The EP faculty are actively involved in clinical research and in investigator initiated clinical research, publishing routinely and participating in multicenter trials. They are an ACGME certified clinical cardiac electrophysiology training program.

The team strives to be the go-to resource for difficult heart rhythm management problems in the state, having the equipment and skills to safely, effectively, and efficiently handle whatever may come their way.

Please send a selfie of your team to OneIUCV@iu.edu with a short caption of how you help achieve our Vision so we can share with the world!

Exciting Opportunity within #OneIUCV

IU Health Physicians and IU School of Medicine is seeking a patient-focused Medical Director for the Cardiovascular Critical Care Unit (CVCC) to collaborate with our highly skilled teams in Indianapolis. To apply, visit the IU Health Career's page

Do you have a story that reflects the strength of our statewide system for cardiovascular care? Please email OneIUCV@iu.edu so we can share with the team!

Study Recruitment and Social Media

Tue, 03 Aug 2021 00:00:00 Z

Social media has emerged as a promising space for data acquisition and study recruitment, due to the vast number of diverse users and abundant, accessible data. Taking advantage of this incredible research resource also raises important ethical questions. As part of a larger project examining ethical challenges posed by digital technologies, the IU Ethics, Values, and Technology project recently hosted three webinars covering the promise and perils of research using social media, focusing on studies on sexual health, attitudes towards disease, and adverse drug-drug interactions. With support of Lilly Endowment Inc., Indiana University is studying ethical issues raised by digital technologies that span human activities “from science to business to culture to politics,” aiming to develop “integrated initiatives to better equip students and faculty to confront and address these ethical challenges presented by our digital world.” All the webinars are available on the project’s website (https://digitalethics.iu.edu) and through the links provided at the end of this post. The researchers shed light on numerous topics involving research ethics but perhaps the most persistent and The challenging topics discussed in the webinars center on study recruitment and use of data from social media.

Drs. Lisa Carter-Harris and Amanda Gesselman each focus on study recruitment as a part of their respective webinars. Dr. Carter-Harris shares her experience using social media to recruit for lung cancer screening studies, while Dr. Gesselman explains how social media has helped recruit participants in her sexology research. Taken together, these two webinars highlight the strengths but also raise important questions about consent and the relationship of the researcher to her participants when they are recruited over social media.

There are several advantages to using social media for recruitment. First, this sort of recruitment can save researchers money, which may be reallocated elsewhere in their projects. Another benefit is keeping participants better informed and involved in the project. Social media offers an open and user-friendly avenue for communication between researchers and their participants. This is a promising area for creating stronger relationships and trust between researchers and the public. One final advantage is the potential to recruit a larger and more diverse participant pool. Not only does this increase the validity and reliability of the study’s results, but it also diversifies the participant groups and ethically represents historically excluded and exploited groups in the scientific literature. This can ultimately bring our scientific work towards more equitable and inclusive ends.

One of the most ethically challenging parts of using social media to recruit participants is consent and communicating risk. While similar issues arise for other ways of recruiting, what is relatively unique is the increased risk to a participant’s social media contacts. Social media is a place where people message, post and repost, and tag other people regularly. These interactions increase the likelihood of an individual’s information finding its way into a study’s data set without their consent. Researchers must therefore be aware of the increased risk of unethically involving a participant’s contacts when recruiting on social media.

For example, consider Dr. Gesselman’s current research on how members of the LGBTQ+ community use social media to mediate their relationships. Participants’ posts will often feature sensitive information about other users. Consequently, the researcher must communicate not only the risks of identification to the participants themselves but also the risk they introduce to their contacts. The high social connectivity characteristic of social media makes this “bystander risk” a much more prominent consideration for social media researchers as they recruit in this space.

Recruitment represents just one use for social media in furthering scientific research. It also has great potential as a place where people discuss their experiences with health and disease, which researchers can tap into to establish clinically important relationships. Drs. Natalie Lambert, Wendy Miller, and Rion Correia each share their experiences using social media to discover information regarding health, disease, and treatments in their webinars. Dr. Lambert’s most recent work performs a qualitative analysis of posts in the Facebook group “Survivor Corps,” a group for people dealing with long-term COVID symptoms. Dr. Miller’s work largely focuses on correlations between post content and sudden unexpected death due in epilepsy (SUDEP). Lastly, Dr. Correia’s research bridges social media activity with electronic health records (EHRs) to better understand certain drug-drug interactions (DDIs). Using social media in these ways pose important questions regarding de-identification and obtaining consent to study social media behaviors.

There are a few options available to researchers when turning to social media for data. One option is focusing on publicly-available activity (e.g., public posts and reposts), which often does not require the researcher to obtain permission to use the information in her data. Proper de-identification, however, is still necessary to protect the owner of the post. This also comes with the important caveat that study type (i.e., longitudinal studies) may necessitate stricter standards of consent regardless of whether the post is public or private. Another option is private posts. These often do require prior participant approval for research use. Ultimately, it is up to the type of study and IRB review process to determine the level of consent researchers must obtain for their social media studies.

Other studies, like Dr. Correia’s on DDIs, not only perform qualitative analyses of posts involving certain drugs but also link the posts to information stored in health records. Linking these two is a promising step, but one which requires a much more involved consent process.

Perhaps the most involved is reaching out and obtaining individual consent. Dr. Correia and Dr. Miller used such a strategy while studying SUDEP and social media post content by having the participants’ families posthumously donate their social media timelines. This type of research requires a lot of work, which is evidenced in their only having 12 participants in the study. Other ways to bridge the two is to use anonymized records. Though less time consuming, it is harder to draw concrete connections between an individual’s social media behaviors and their clinical health. We can expect researchers to find ways to make these connections easier, but participant confidentiality and privacy remain the key ethical consideration in these types of studies. Solving these problems of privacy and confidentiality will decide how rapidly researchers draw clinical connections to peoples’ social media presence.

Many of the considerations common to our discourse on research ethics receive added emphasis when considering social media as a recruitment tool and place for data acquisition. Among these are consent, risk communication, de-identification, and confidentiality. These webinars provide only a glimpse into the budding ethical conversation surrounding researchers’ social media usage, and we will be tasked with rethinking our ethical understandings to accommodate social media’s growing role in advancing our health sciences. To view the full webinars, follow the links below:

Ethically bridging digital health data: From social media to electronic health records

Ethical Concerns and Strategies for Collecting Sexual Health Data

Using Social Media to Reveal Health Care Problems, Behaviors, and Information Needs

Chuckstrong Backyard Huddle raises nearly $2.5 million for cancer research

Mon, 02 Aug 2021 00:00:00 Z

In a night that brought together cancer survivors, researchers and philanthropists, the Chuckstrong Backyard Huddle raised nearly than $2.5 million July 29 for cancer research at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.

Hosted by the Indianapolis Colts and former head coach Chuck Pagano at the home of Colts owner Jim Irsay, the event took a surprising turn that bridged football and basketball. Irsay spoke of the brilliance of IU cancer researchers who are working to improve treatment and search for cures.

“We’re going to have a little bit of fun and put the coach under pressure,” Irsay said.

Guests gathered in a basement basketball court where Irsay announced Pagano would be shooting baskets – each worth a $100,000 gift toward cancer research. Pagano sunk 10 shots for a total gift of $1 million. Irsay offered another $1 million for a free throw. After a pep talk from former Colts offensive tackle and Indiana native Joe Reitz, Pagano hit the shot amid cheers from guests (watch the shot captured by WISH-TV). With that final shot, Irsay made a total gift of $2 million to cancer research.

To date, the Chuckstrong initiative has raised nearly $10 million since 2013. Funds have been used to help recruit new researchers, provide seed money for researchers to launch new ideas, and purchase laboratory instruments to support innovative cancer research.

“The Chuckstrong Backyard Huddle was a remarkable and inspirational evening that celebrated not only the importance of cancer research, but also the strength of survivors,” Kelvin Lee, M.D., director of the IU Simon Comprehensive Cancer Center, said. “We know that research cures cancer, and we are grateful to Mr. Irsay and so many others for their unwavering support of our mission to discover better approaches to prevention, diagnosis and treatment of cancer.”

During the event program, guests learned about the impact of IU cancer research and expertise in a moving video about Stephanie Pemberton, a cancer survivor and Indianapolis Colts vice president of marketing. Pemberton detailed her triple negative breast cancer diagnosis journey and treatment.

Due to the COVID-19 pandemic, the 2020 Chuckstrong event was canceled. This year’s event was reimagined as the Chuckstrong Backyard Huddle, which nearly 100 guests attended. Attendees included sponsors for the 2020 event, cancer survivors and researchers.

Pagano’s story

Chuck Pagano’s diagnosis of acute promyelocytic leukemia in September 2012 shocked Indianapolis with the reminder that we are all vulnerable to the devastating effects of cancer. The Chuckstrong movement quickly began providing an opportunity for our city to visibly support Pagano as his team rallied and marched toward the playoffs.

Pagano endured difficult treatments under the guidance of Dr. Larry Cripe, a hematologist and cancer center researcher, but he ultimately returned to his head coaching duties on Dec. 24, 2012 – a day that inspired and captivated all who have been touched by cancer.

IMPRS students take on summer research

Thu, 15 Jul 2021 00:00:00 Z

Fourteen medical students are experiencing medical innovation first-hand as they work alongside several orthopaedic faculty members and conduct research as part of the Indiana University Medical Student Program for Research and Scholarship.

The program – known as IMPRS – pairs students who just completed their first year of medical training with a faculty mentor. For eight to 12 weeks of their summer, the students conduct laboratory/translational or clinical research, network and attend seminars. Their work culminates in an end-of-the-summer oral and poster presentation.

IMPRS is IU School of Medicine’s official program for summer medical student research. This opportunity is specifically designed to attract those who are between their first and second years of medical school because it’s an ideal point in their education to take on such lengthy research projects.

Here are the students and orthopaedic faculty mentors working together this year, and a bit about each students’ project:

The Kacena Lab

Faculty mentor: Melissa Kacena, PhD

Christopher Dalloul: Bone health in a mouse-adapted model of SARS-CoV-2

Nicholas Hux: Effects of targeted TMP on fracture healing in aged mice

Abduallah Elsayed: The effects of targeted SRT1720 on bone fracture healing and pain behavior in mice

Samuel Zike: Effects of TMP and high fat diet on bone fracture healing

Nikhil Tewari: Effects of megakaryocyte products on bone marrow angiogenesis

The Gingery Lab

Faculty mentor: Anne Gingery, PhD

Nicholas Thelen: Studying the role of cellular senescence and immune evasion in musculoskeletal pathology, with the long-term goal of reducing senescent burden in aged and diseased tissues to improve healing.

The Meneghini Lab

Faculty mentor: Michael Meneghini, MD

Joshua Hsien-Shu Chang: The relative contribution of medical comorbidities in the OARA score to safe same-day and next-day discharge after total joint arthroplasty: A machine learning analysis

Ethan Cornwell: The influence of medial collateral ligament and lateral collateral ligament pie crusting in primary total joint arthroplasty on patient-reported outcomes

Colin Harris: Radiographic outliers, revisions, and functional outcomes in fixed-bearing medial unicompartmental arthroplasty

Luci Hulsman: Time required for planned and unplanned episodes of care in aseptic and septic hip and knee revision surgery

Amrit Parihar: Instability in patients with lumbar spine disease or lumbar fusion undergoing posterior approach vs. direct lateral approach primary total hip arthroplasty

The McKinley Lab

Faculty mentor: Todd McKinley, MD

Rebecca Nunge and Kayla Gates: Both are working on a project entitled Developing a Minimally Invasive Cell-Based Model to Predict Response to Major Trauma.

Taylor Luster: The objective of Taylor’s summer research is to measure trauma imposed by hemorrhagic shock and a femur fracture in a mouse model to determine if specific cytokines can serve as predictive values for response to trauma. This research will help determine how intrinsic differences between individuals can help predict survivability in polytrauma.

Vaccinating in Indiana

Tue, 06 Jul 2021 00:00:00 Z

From April-May 2021, I committed 94 volunteer hours to vaccinating the general public of Indianapolis against COVID-19 at IU Methodist Hospital, the IUPUI Student Campus Center, and the Indiana Motor Speedway. I’ve given at least several hundred vaccines, likely exceeding a thousand (as of this writing, 3,005,438 Indianans, or 44%, have received at least one COVID dose).

I am obviously a proponent of the COVID vaccines. The majority of the (vocal) people I vaccinate are of a similar, if not more neutral, mindset (it is, after all, the subset of Indianapolis that willingly seats itself beneath my waiting syringe). With the institution of mandatory vaccination for IUPUI students and IU Health faculty, though, the population at my stations has subtly changed, now hosting a larger proportion of the hesitant or undecided. I make a point to ask about my patients’ attitudes, and, though I had anticipated many of these arguments (the side effects, fear of needles, time constraints, autonomy…), others surprised me, both in content and fixedness.

A case: There was the man who feared the possible aftereffects of the injection; he complained to me about his sister, who had “three weeks” of malaise following vaccination, along with a mysterious tendency to drink “gallons of water.” Other patients claimed to have witnessed odd or unrelated side effects, including hair loss, unremitting gas, and an increased frequency of hiccups… in addition to the advertised (and better-documented) fevers, chills, aches, pains, and fatigue. My approach: I affirmed to this patient that the effects of the vaccine can be palpable, but they are usually not so… well, weird. My argument that was not heeded. It did little to quell this patient’s firsthand experience of puzzling, alarming, seemingly linked symptoms. In the end: I’ve been taught that logic and data don’t easily change minds. I was resigned to admit that some patients clearly did not or would not believe my evidence-based medical advice. The same goes for much of the data about the vaccines, immunology, and epidemiology. I was simply thankful the patient accepted the shot.

A case: Another patient had a strong history of anaphylaxis and was extremely anxious. He showed me his collection of epi-pens and his allergist on speed dial. Begrudgingly, he was vaccinated, and, to my knowledge, suffered no severe physiological reactions. My approach: I stood aside from this patient’s reasoning. He had considered the chance of a life-threatening reaction to a vaccine against a decreased chance of catching COVID-19 and had chosen the latter. I’m not sure if I would have made the same choice. In the end: for some, though a decision may not be literally ‘life and death,’ it bears similar significance. And, if I can’t argue with the anaphylactic patient’s personal cost-benefit analysis, then I probably shouldn’t try to argue with other patient’s analyses if their understanding of the situation is intact and they perceive grave consequences to any facet of a medical decision.

A case: A teenaged patient spoke to me about the threat of judgment from her family, who remain staunchly against vaccination, almost to the point of altogether disbelief in COVID. She told me her mother would most assuredly not let her visit over the summer if they knew she’d gotten the shot. She imagined her mother saying, “That’s not how we raised you.” She looked tearful at the imagined condemnation from her parents, but still submitted to vaccination because she though it was right. But it took her weeks of what seemed to me obviously heated internal discussion and turmoil. My approach: I told this patient I was glad she decided to get the shot, and that her secret was safe with me. In the end: some consequences are unfathomable by outsiders, and, though considered nonsensical or arbitrary by some, still have real sequelae.

A case: One spectator at the Speedway asked me, “Where are all those sick people? I haven’t seen anyone headed to the hospital.” He had been watching us vaccinate for several hours. My approach: I told this man about my parents-in-law, who both contracted difficult cases of COVID-19, but who luckily survived with only minor (though long-lasting) aftermath. I told him about the dozens of patients I’d seen in the ICU during rotations and shadowing palliative care unresponsive, hooked up to ventilators. In the end: This spectator refused vaccination but thanked me for speaking so intimately. Though shared vulnerability may occasionally work to convince people of a truth hard to swallow, they can also come off (unpalatably) as scare tactics.

A final case: I met a woman with countless self-harm scars covering her upper arms, down to her wrists. She said she didn’t want to get vaccinated because someone would see her arms. My approach: I took her behind a privacy curtain, and she wept as the rolled up her sleeves. In the end: I thought for hours about how brave this woman was. I wish I could say more.

Vaccinating Indianapolis has been a pleasure, and a monumental opportunity for personal and professional growth. Medical school offers plenty of didactic instruction in speaking to patients, managing fear, and tempering expectations, but the skills go unpracticed and unanalyzed when unapplied to real encounters. We are primed to recognize the reasons why patients may feel a particular way towards a particular intervention, but we are not taught how to understand and process those reasons. We are not taught when those reasons are better left untouched. Vaccination is a personal choice, and I’ve offered a biased cross-section of those who accepted it with varying degrees of hesitation. Throughout my experience, I learned to argue patient’s hesitancies less and listen to them more.

April 2021 Newsletter

Wed, 21 Apr 2021 00:00:00 Z

Larry Einhorn, MD, answers questions about testicular cancer

Tue, 13 Apr 2021 00:00:00 Z

Testicular cancer, though rare, is a cancer that primarily affects young men. It also differs from other forms of cancer in that it has a high cure rate — but first, it has to be detected.

We asked the world’s foremost authority on testicular cancer, Larry Einhorn, MD, the Livestrong Foundation Professor of Oncology and professor of medicine at IU School of Medicine and a physician scientist at IU Simon Comprehensive Cancer Center, about what can be done to discover and treat testicular cancer.

Q: What is the average age of a testicular cancer patient?

A: Most patients are teenagers or in their 20s or 30s, so it is a young man's disease.

Q: What are the signs of testicular cancer that men should watch for?

A: Twenty years ago when Lance Armstrong was diagnosed, he did a great job in raising public awareness. If a man feels pain in the testis or a fullness, a mass or a hardness in the testis, he shouldn't assume that it is just an infection or nothing of consequence. It should be checked out by a physician who will determine whether it is anything serious. Patients can’t do their own physical examination and make this diagnosis.

Q: Do men tend to overlook or minimize the signs and symptoms? Is that something you see contributing to occurrences of testicular cancer?

A: I think men are less apt to overlook the symptoms now than before testicular cancer became more openly discussed. However, when you are 25 years old, which is the average age, the thought of getting cancer just doesn't cross your mind. And so there can be anywhere from a several-week to a several-month delay from the time a patient has the first symptoms to the time that the patient sees a doctor.

Q: Is it a type of cancer that a man could be genetically predisposed to get?

A: Well, yes and no. It occurs in only 1 percent of all men who have cancer so it is a relatively rare disease. We see about 8,000 to 9,000 new cases a year. The known risk factor for getting testis cancer is being born with an undescended testis where, as a small child or an infant, a pediatrician will arrange for a surgeon to push the testis back into the scrotum. If you have a brother or a father, what we call a first-degree relative, who had testis cancer, instead of the standard risk of 1 out of 400, it becomes a risk of 1 out of 300. So yes, it's an increased risk if you have a relative with testis cancer, but it's still a very rare disease.

Q: Are there any behavioral or lifestyle changes that someone can do to help prevent testicular cancer?

A: Unlike lung cancer which can occur in heavy smokers, many cancers -- such breast cancer and many other types of cancer -- there is no definitive reason people get it. Many times, people get malignancies just as they get heart disease or neurological diseases, for no particular reason.

Q: If a man gets screened and receives a testicular cancer diagnosis, what should his next steps be?

A: Once you have an ultrasound done and a mass is identified in the testis, the next step is to see a urologist, who will make an incision in the groin and surgically remove the testicle. Then the patient will receive tests to see whether the cancer is confined to the testis or whether it has spread to other parts of the body. That will determine whether the treatment will be observation alone after removal of the testis, or surgery to remove abdominal lymph nodes, or chemotherapy if the disease has metastasized and is more widespread.

Q: What is the outlook for testicular cancer patients whose disease has become metastatic?

A: As is true with many cancers, the more extensive the disease, the harder it is to cure, but testis cancer is unique among all malignancies in that it has such a high cure rate. So, if we look at all patients who have metastatic disease that require chemotherapy, about 70 percent will be cured with their initial chemotherapy. Of the remaining 30 percent who are not cured with their initial chemotherapy, about half of those will be cured with subsequent chemotherapy. So, about 80 percent to 85 percent of patients will be cured.

Q: Can a man usually maintain his current lifestyle while undergoing treatment for testicular cancer?

A: Absolutely, and sexual function is not affected. The other remaining testis will work overtime and produce the amount of testosterone previously produced by both testicles. There are some patients for whom the testicle doesn’t work overtime and those patients will need to be on what we call replacement testosterone, which can be done as a gel applied to the skin once a day, or as an injection every two or three weeks. Most patients who are cured either with surgery alone or surgery plus chemotherapy are soon back to work and doing normal activity.

Indiana Myeloma Registry tracks individual patient journeys, data in search of a cure

Thu, 25 Mar 2021 00:00:00 Z

Hoosiers with multiple myeloma can provide important data to researchers at Indiana University Melvin and Bren Simon Comprehensive Cancer Center who are searching for a cure. The Indiana Myeloma Registry is seeking participants throughout Indiana.

Multiple myeloma is a cancer of white blood cells called plasma cells. While it’s a relatively uncommon cancer, it’s a devastating diagnosis. An estimated 670 Hoosiers will be diagnosed with myeloma this year and 260 will die from this blood cancer.

“Myeloma is a very heterogeneous disease, meaning every patient story is unique to them—the way the disease presents itself, the way it affects them, and the way they respond to the treatment,” said Mohammad Abu Zaid, MD, a physician-scientist who helped launch the registry at IU before moving on to NYU Langone Health. “It makes my clinic very interesting because it's never the same story.”

With the Indiana Myeloma Registry, researchers believe they can learn from each of those stories to gain a better understanding of multiple myeloma. The cancer takes many years to develop and goes through stages before it may be diagnosed. Because of this, the cancer cells are not only different from patient to patient, but also within a person.

The registry allows patients with myeloma and precursor conditions to provide their medical history, treatment data and a saliva sample to researchers who will use the collective data to better understand the cancer.

“With the Indiana Myeloma Registry, we're trying to write the story for each patient with myeloma from the time of their diagnosis and all through their treatments in real-time, so that we are capturing accurate data and all the data points that we believe are important,” Abu Zaid said. “We can then use all of that information to answer some of the most important questions in myeloma with the goal of finding a cure for myeloma.”

The Indiana Myeloma Registry opened in 2018, and more than 500 patients treated at IU Health have joined so far. Now the registry is open to patients throughout the state, so researchers gather more myeloma patient journeys to better understand who is most likely to develop multiple myeloma, what treatment works best for which people and what causes the blood cancer.

“We're trying to get every patient with myeloma to join this study so we can track more and more patients and include all Hoosiers with myeloma in the registry,” he said.

Participants in the study provide a saliva sample via mail, complete health history and quality of life questionnaires, and allow researchers to collect medical records data to track information such as treatment and lab tests. Saliva samples will be used to extract DNA to learn if patients have inherited risk factors for myeloma or increased risks for side effects from treatment. Patients at IU can also donate blood and bone marrow samples to the registry.

Patient data collected by the registry will be used by myeloma researchers at the cancer center such as Rafat Abonour, MD, Brian Walker, PhD, Fabiana Perna, MD, and others.

Researchers know men are more likely to get myeloma and that Black men and women are twice as likely to develop the disease. Researchers are working with The Polis Center at IUPUI to examine registry data to identify and understand other risk factors for myeloma, such as environmental or medical history.

The Indiana Myeloma Registry is also partnering with Indianapolis-based software development company LifeOmic. The company is building a platform where clinical data, surveys, biospecimens, and genetic data can all be visualized for researchers.

Abu Zaid said he has been humbled by how willing patients are to join the registry, knowing it may not change their treatment, but could help others who will be diagnosed with myeloma. He hopes others throughout the state will join.

“It's a great opportunity for myeloma patients to participate and be part of finding the cure for myeloma,” Abu Zaid said.

Participants of all races and backgrounds throughout Indiana are needed. To learn more and enroll, visit: www.cancer.iu.edu/myelomaregistry/. If you have questions about the study, email myeloma@iu.edu or call 317-278-0808.

The Indiana Myeloma Registry is funded in part by support from the Indiana University Precision Health Initiative, Miles for Myeloma, the Harry and Edith Gladstein Chair and the Omar Barham Fighting Cancer Fund.

Vaccine Fairness – The Big Picture

Mon, 01 Feb 2021 00:00:00 Z

The vaccine is here and distribution is ramping up, providing hope that we are finally turning the corner on this pandemic. But along with the vaccine comes important ethical questions and debate. Here are my quick thoughts and opinions:

Rationing is inevitable

It’s nothing new for medicine, or for society, that there is greater need than supply. As Dan Callahan emphasized again and again in bioethics, it is inevitable that there is always more need for medical care (possible treatments that can help people) than can be provided at any time. Some people get more valuable healthcare than others, in any system. Price and access play a major role in the United States, due to our patchwork system of insurance, while elsewhere there’s more centralized planning and governmental choice. But it’s all rationing, no matter the system: a limited amount of precious resources are being directed to some and away from others. (See Peter Singer’s excellent article from 2009 in the New York Times)

Need that exceeds supply, and limited desirable resources, is also standard, of course, for society more generally. Everybody would like to have more of the things they like, but we can each only have some. All of us might enjoy a better car, more space in our home, nicer shoes, etc., but we only get some of those things. A society can distribute these things through a capitalist system (distribution by price and wealth), or with centralized planning (e.g. socialism or communism). But every system distributes goods, and any system can be evaluated for achieving or failing to achieve justice, specifically “distributive justice,” as philosophers call it.

Utilitarianism and Justice

Given we now have a limited amount of vaccine and many people who could benefit from it, how should we decide who gets it first? How do we achieve distributive justice in this arena? So far, we are using a largely Utilitarian calculus, a common organizing principle for public health: We are trying to get the vaccine to people with the highest risk, where the shots will best improve the health of our population. That means healthcare workers and public safety workers first, then others who have the highest risk from infection, then moving on to those at lower risk. In many places, health risk is calculated simply by age, starting with those who are oldest, although especially prioritizing those living in nursing homes, since they have seen the greatest ravages in this pandemic.

Philosophers call this “Utilitarian,” where the act is chosen that can be predicted to create the most happiness and reduce the most suffering for the most people. With vaccine distribution, we aim to best promote happiness and reduce suffering by protecting health in society overall. The question is not who deserves to get the vaccine first, but who should get it in order to benefit society, overall, best. The idea is a bit counterintuitive: From this perspective, the ethical reason to give the vaccine first to the people who will benefit the most is not for them, but since by benefiting them, you are best benefiting society overall.

Even with such a clear goal, there are an uncountable number of different ways to pursue it. One could prioritize teachers, since it will benefit society so much to reopen schools, and with schools reopened they have significant risk. One could prioritize other essential workers such as grocery store employees, others in the food industry, or bus drivers, etc., since by prioritizing them you could improve and protect the services they offer.

And one could try to parse that health risk more carefully than just prioritizing advanced age. People with certain diseases or conditions may have higher risk than many people older than them. With this reasoning, New Jersey decided to give vaccines to smokers early, given the increased risk that this habit brings.

Choice and Tradeoffs

First, there is no single right answer for distribution, even if there are some wrong ones. I’m glad to say that nobody has proposed selling the vaccine to the highest bidder, which would clearly be a bad approach. While all states are following a system aimed at maximizing health benefit - vaccinating healthcare workers and the elderly first - they differ in details. And there is something to be said for such variation, given that many different systems may be ethically acceptable. Imagine the pressure and delay in trying to settle on a single national system.

Second, the goal of optimizing distribution more precisely – by more carefully identifying people’s risk levels - stands in tension with the inevitable inefficiencies that such a system creates, and dangers of people gaming the system. Take smokers: Do we know who is a smoker? If a person can get the vaccine by simply saying they’re a smoker, and maybe smoking a few packs to get their urine to turn positive for testing, then some people (many?) probably would. Or take asthma, another health condition that puts people at risk and could be used to prioritize some people to receive the vaccine. But how would we determine who has severe enough asthma to move up in line? Who would determine this and how, based on what testing? Should doctors be trying to make these decisions, writing letters and filling out forms to say which of their patients should get the vaccine, when they are so busy caring for the ill?

I believe that age, and really only age, is the right metric, probably without trying to parse risk more carefully, though I admit uncertainty. The evidence is clear that those who are older have significantly elevated risk of mortality and severe disability from COVID. Age is easy to check on driver’s licenses or other ID cards and there are public records. All other ways of gauging risk get squishy and complicated and, again, open the door to gaming the system. I don’t say this blithely, since I realize that this sort of decision has life and death implications, as does every decision about vaccine distribution. Luckily, I’m in no position to make these decisions, only to say what I think.

Cheating

How bad is line jumping, of the sorts that have been reported nationwide and indeed worldwide? Answer: Bad, but please keep it in perspective. Just as there is an overall tension between the goals of optimizing impact and optimizing speed of getting the vaccine into millions of arms, so there is a tension between getting the vaccine out there, however we can, and stamping out all cheating. I abhor but can live with some people at low risk but high social power getting the vaccine, as long as it is a low percentage of the shots. I’m not saying to stop trying to block such cheating, but I’m also saying that we can’t get hung up on it.

When the IU Center for Bioethics celebrated its 10th anniversary in 2011 (our 20th is later this year), Art Caplan, PhD, a noted bioethicist, gave a talk where he critiqued the claim by some that people in the United States will never accept rationing of healthcare. As he pointed out, we already ration care by price, as discussed above. And we even accept centrally planned rationing, for instance in distributing organs for transplantation. Every day, someone’s life is saved since they were selected to receive an organ like a liver or heart, while someone else dies waiting, since they did not receive that organ. And somehow this is accepted.

Dr. Caplan proposed that there are two key reasons for this acceptance of rationing: First, the limited supply of organs is accepted as real and not artificially created. Nobody thinks that the scarcity was created intentionally or through incompetence of the government. Second, the system for selecting recipients is seen as fair and based on medical need, not on things like power, money, or connections.

Our vaccine distribution system must aim at both goals: people must know that those in power are distributing vaccine as quickly as possible, and rationally and fairly. Prioritizing smokers, I think, has the danger of undermining the whole system by raising concerns about fairness. Rampant line jumping would have the same effect. We can stomach some cheating, even if we don’t like it. But if there is too much, and the entire system will start to look arbitrary and rigged, and it will crumble.

Take home points

Vaccine distribution must prioritize the health of society, choosing people to receive it first based on optimizing protecting health, and reducing disease and death, in the population overall.

Higher age, especially over 60 or 65, is an important marker for risk, and thus an excellent way to distribute the vaccine. The fact that age can be relatively easily checked and verified is key to its being such a good way to prioritize some to receive the vaccine.

Distributing the vaccine based on health risks from comorbid conditions or jobs faces challenges of line drawing, confirmation, and fairness. (Think of smokers again, a health risk that reflects choice, though also addiction.)

And while some cheating is inevitable, it must be kept to a minimum, to protect the integrity of the system. Only with an ethical system can we move forward together.

Dr. Koch answers questions about prostate cancer

Tue, 17 Nov 2020 00:00:00 Z

Although men may not like to talk about it, prostate cancer is the most common cancer and the second leading cause of cancer death among men in the United States, according to the National Cancer Institute. Al Roker, the Today show weatherman, recently announced he was diagnosed with prostate cancer and that he had it removed surgically, which put a spotlight on the disease.

Michael Koch, MD, chair of the IU School of Medicine’s Department of Urology and a member of the IU Simon Comprehensive Cancer Center, is a prostate cancer expert with 35 years of experience. He and a colleague were the first to develop the high-intensity focused ultrasound (HIFU) research protocol at IU. In 2017, he was the top honoree in the Indianapolis Business Journal’s Health Care Heroes awards program in the “Advancements in Health Care” category for his HIFU work.

We turned to him for some answers about prostate cancer.

Q: Al Roker is 66 years old. Does prostate cancer only affect older men?

A: The likelihood of being diagnosed with prostate cancer increases with age and to some degree depends on when primary care physicians begin screening. The average age of men diagnosed with prostate cancer currently is in the 55-65 range, but we do see men sometimes diagnosed as young as their 40s.

Q: Other than age, what else contributes to prostate cancer?

A: The causes of prostate cancer are not fully known. Certainly, age is a major risk factor. Other factors that have been proposed to increase a man’s risk of being diagnosed with prostate cancer are race (Black men are at a higher risk), obesity, and a diet rich in animal fat.

Q: What are some symptoms that should lead men to see their doctors?

A: Most men that are diagnosed with prostate cancer have no symptoms. Many of these men have concurrent non-cancerous prostate enlargement that can cause decreased urinary stream, urine hesitancy, and sometimes urine frequency. Men who are unfortunately diagnosed with very advanced prostate cancer may have pain in their bones, but this occurs in only a few percent of men, generally with very high PSA values (blood test).

Q: Does prostate cancer impact Black men differently from white men? If so, why is that?

A: The general belief is that Black men have more aggressive prostate cancers and that they do not do as well after treatment. The cause of this is not clear.

Q: Most men, at least of a certain age, have probably heard of PSA (prostate-specific antigen) and digital rectal exam (DRE), two tests that look for possible signs of prostate cancer. At what age do you suggest men have one or both of these screenings? Is one better than the other?

A: The guidelines for screening men for prostate cancer are controversial and have varied somewhat over the years. Most believe that Black men and men with a strong family history of prostate cancer should begin screening earlier, generally age 40-45. Men who are not at increased risk can generally start screening around age 50. Equally important, the literature does not support screening asymptomatic men beyond the age of 70.

Q: Treatment options range from so-called “watchful waiting” to surgery to immunotherapy and more. How would you summarize all of the available options?

A: Most importantly, a large portion of men diagnosed with prostate cancer have small non-aggressive prostate cancers that do not require treatment but do require monitoring. Few of these cancers ever require intervention.

In men with cancers that are more serious and do pose a threat to the health of the patient, some type of removal or destruction of all or part of the prostate is generally indicated which might include robotic surgery, various forms of radiation, or a variety of techniques to “cauterize” just a part of the prostate.

Q: You’ve been a pioneer in your field. What do you see on the horizon in terms of advances against prostate cancer?

A: There are several advances in the last few years, and I would break them down into three areas. First, there have been very significant advances in selecting which tumors will behave aggressively and which ones will follow a very non-aggressive course. Second, we have less invasive techniques to treat prostate cancer in some men and allowing some of those men to avoid the side effects that can occur after more aggressive treatment. Third and most excitingly, there have been very substantial advances in molecular imaging of prostate cancer allowing us to more accurately determine which patients might benefit from treatment of prostate cancer and also tailoring the aggressiveness of that treatment to that specific patient’s need.

Q: Men, in general, can be reluctant to see a doctor. That can be particularly true with this type of cancer. How do you encourage men – or the people around them that love them – to be checked out by their physicians for prostate cancer?

A: This is the toughest question. Many men tend to avoid any type of health screening whether it be general check-ups for blood pressure and diabetes or other conditions and some seem to believe that they are invincible. Many believe that they are too busy to go get a check-up. Frequently, men come in at the prompting of their spouses. Men should realize that prostate cancer has become the most common cancer diagnosed in men and the most common cause of cancer death in men. Urologists now have the tools to carefully determine who is at risk for cancer and who is not, and to customize treatment to each and every patients’ specific circumstances thereby minimizing the side effects of treatment while curing most men of their most frequent cause of cancer death.

To learn more, visit https://www.cancer.gov/types/prostate.

Pain and Prejudice

Thu, 12 Nov 2020 00:00:00 Z

Last week, Dr. Colin Halverson, PhD, addressed ethics enthusiasts in a talk entitled, “Pain and Prejudice,” for the Fairbanks Lecture Series in Clinical Ethics. Dr. Halverson studies the clinical journeys, identities, and realities of patients diagnosed with (hypermobile) Ehlers-Danlos Syndrome, a relatively elusive and professionally understated and misunderstood disease of the connective tissue. In this IUCB blog post, I’ll introduce Dr. Halverson, and then discuss his talk.

Dr. Colin Halverson is a Center Investigator at the IU Center for Bioethics, as well as Assistant Professor of Medicine at IU School of Medicine. Dr. Halverson received his PhD in medical and linguistic anthropology at the University of Chicago, and subsequently completed fellowships in bioethics at the University of Chicago and Vanderbilt University. His research focuses on medical genetics, patient-doctor communication, consent, and return of clinical/genetic results.

In “Pain and Prejudice,” Dr. Halverson describes his ethnographic research, including clinical participant-observation and interviews with 21 patients suffering hypermobility-type Ehlers-Danlos Syndrome (hEDS). hEDS is an inherited disease, though with an (as of now) unknown specific genetic cause. It affects mostly females (95%), with an estimated incidence of 1/5,000. Diagnosis of this disease is tricky, because it resembles other connective tissue disorders, and can have (especially early on) nonspecific symptoms. hEDS can cause joint hypermobility, stiffness, chronic pain and fatigue, occasional cardiovascular and gastrointestinal complications, dysautonomia, osteoarthritis, and low bone density. hEDS is a debilitating illness with lifelong effects.

Dr. Halverson refers to the clinical journey of his hEDS subjects as their ’diagnostic odyssey:’ an arduous experience that occurs over many years as patients seek diagnosis and treatment of a disease they’ve largely been left to discover on their own. The diagnostic odyssey of hEDS tends to include the following moments and/or patterns:

The ‘always-already moment,’ wherein patients recall a history of childhood symptoms not yet recognized as debilitating or pathological.
The ‘trigger moment,’ wherein the patient fully commits to the diagnostic odyssey.
The ‘road of trials,’ wherein symptoms proliferate and worsen.
Secondary effects of the disease, which affect the patient’s personal life, often necessitating the sacrifice of hobbies and relationships.
Psychological sequelae as a result of the aforementioned life changes/losses, which are caused by an outwardly and seemingly ‘invisible disease.’
Clinical ignorance, as doctors tend to disbelieve patient accounts of vague symptoms; physicians can appear aloof or distrustful of their patients, which alienates them in turn.
Self-diagnosis, wherein the patient discovers hEDS and external support systems of those who have lived with the disease; the patient can now begin coming to terms with the reality of hEDS as a disability or chronic illness.
The ‘diagnostic apotheosis,’ wherein a patient’s self-diagnosis is vindicated by an agreeing clinical diagnosis, heralding a sense of relief.

Though arguably easier to read, numbering these experiences as I have does a disservice to Dr. Halverson’s goal of giving a narrative pattern to the stories he collects from his participants (hopefully he’ll forgive me). Narrative is more inviting, allowing us to participate in the experiences of others. The challenges faced by hEDS patients reveal and accentuate the depths that exist between clinicians and patients, and how critical diagnostic services (or even effort), good listening, and long-term relationships can be in affirming the identities and adversities of these patients. Though the ability to take a more ‘humanistic,’ empathetic view is emphasized in medical school and clinical training, it can be largely lost in the quotidian practices of physicians who easily become strangers to patients’ experiences outside of the exam room, or who assign patients with nonspecific complaints the reputation of ‘poor historian.’ If the clinician can recall the odyssey of hEDS patients, perhaps he will be more careful in his interactions with frustrated patients, and more open to hearing nonspecific complaints with a diagnostic, or, at least, empathetic ear.

Find Dr. Halverson's talk online, here.

HPV expert Darron Brown, MD, discusses the vaccine’s dramatic impact on reducing cervical cancer

Wed, 11 Nov 2020 00:00:00 Z

A recent, new study published in the New England Journal of Medicine — which has been hailed as a “milestone” study — confirmed that widespread use of the human papillomavirus (HPV) vaccine dramatically reduces the number of women who will develop cervical cancer. We turned to Darron Brown, MD, a leading authority on HPV, for some answers about this study. Brown is a professor of medicine in the Division of Infectious Diseases and professor of microbiology and immunology at IU School of Medicine and a researcher at the IU Simon Comprehensive Cancer Center.

Do you agree that this is a milestone study? Why or why not?

While other studies have shown that the HPV vaccine is effective against pre-cancerous lesions, this is the first study that conclusively demonstrates that the HPV vaccine prevents invasive cervical cancer. This cancer kills nearly 400,000 women each year worldwide. While cervical screening programs have reduced the incidence of cervical cancer in this country, there are still 15,000 women who die every year from this preventable cancer.

This study, conducted in Sweden, is a milestone in the prevention of cervical cancer. The medical records of approximately 1.7 million girls were examined who were ages 10 to 30 between the years of 2006 and 2017. Some had been vaccinated against HPV and some had not. Invasive cervical cancer developed in 557 women overall, the vast majority in those women who had never received an HPV vaccine. There was an 88 percent reduction in invasive cervical cancer in women who had received an HPV vaccine before age 17 and a 53 percent reduction among women who had received the vaccine at an older age.

Are the study’s findings surprising to you? Why or why not?

The findings of the study are not surprising to me, because the HPV vaccines are highly effective in preventing infection with HPV, the virus that causes cervical cancer. In addition, we know that the HPV vaccines effectively reduce the likelihood of pre-cancerous lesions, which can develop into invasive cancers five to 20 years later. So, it makes sense that the vaccines do what they were designed to do: prevent invasive cervical cancer.

What is the take-away message to the public about HPV vaccination?

Vaccines are the safest and most effective things we do as physicians. Screening programs for cervical cancer are important, but Pap smears lack sensitivity to detect all cervical cancers. In addition, HPV vaccines can prevent other malignancies in both men and women such as oropharyngeal cancer and anal cancer, for which there are no screening programs available.

As I mentioned, the Swedish study showed that the highest reduction of invasive cancers, 88 percent, was demonstrated in the group of young women who had been vaccinated before age 17. This strongly supports the public health policy of vaccinating young boys and girls against HPV at age 11 or 12, before there is a chance of becoming infected.

This study focused on females. What about males and/or the parents of boys/young males? What is the take-away message to them?

Both of my sons have been vaccinated against HPV (and my daughter as well). HPV causes most anal and oropharyngeal cancers. By 2030, more men than women will die from HPV-associated cancers in the United States. It is critical that all boys are vaccinated at age 11 or 12, the same age as for girls.

The study pointed out the need for women in low- and middle-income countries to be vaccinated. As you mentioned in a previous Q&A, nearly 90 percent of all cervical cancer deaths occur in poor and developing countries, such as India, countries in South-East Asia and Sub-Saharan Africa. What can you tell us about your latest work in Africa?

HPV vaccines were FDA-approved in 2006, and approximately 60 percent of girls living in the United States have received the vaccine. However, while 90 percent of all cervical cancer deaths occur in women living in poor countries, few girls are vaccinated against HPV. In Kenya and Malawi, two sub-Saharan countries in which I have worked, fewer than 1 percent of girls have received an HPV vaccine.

We are currently working in Kenya to develop a community-based strategy that will combine screening adult women for cervical cancer with HPV vaccination of children in the same setting. We believe this decentralized approach to cervical cancer eradication will be successful in Kenya and can be applied to other East African countries where cervical cancer is extremely common.

Dr. Marino, others demonstrate the importance of studying the “normal breast”

Tue, 10 Nov 2020 00:00:00 Z

Natascia Marino, PhD, assistant research professor of medicine at IU School of Medicine and a research scientist with the Komen Tissue Bank at the IU Simon Cancer Center, is among the authors of a study published online in npj Breast Cancer. Dr. Marino said the study demonstrates the importance of conducting research on the “normal breast” and that she and her colleagues were surprised by the role fat plays in the development of breast cancer. The study, according to Dr. Marino, provides researchers with an early clue into changes that lead to breast cancer. “For the first time, we will have a view into the earliest changes that lead to breast cancer,” she said.

She answered questions about the study.

In your words, what is the single main purpose of this study?

Our main goal is to understand what causes certain women to develop cancer in their breasts versus women who do not and how the breasts prone to cancer are different from those of healthy women.

What is the key finding?

We identified molecular alterations linked with increased processing of fat in the breast tissue of women two to six years before they had any diagnosis of breast cancer. This suggests that the breast with even a small number of cancer cells, still undetectable by current diagnostic tools, is different from a healthy breast and all the cellular components of that affected breast are working to create a surrounding favorable for cancer growth.

What is the significance of the finding?

We show the possibility to detect abnormalities in the breast associated with cancer before it is detectable by routine screening methods, like mammography. Moreover, we also suggest that the fat cells in the breast tissue may have a key role in promoting cancer by both providing energy to the cancer cells and by inhibiting the anti-cancer immune response.

What are the strengths of your study?

We are the first to look at the alterations occurring in breast tissue donated by women prior to their diagnosis of cancer and compare its features to breast tissue from healthy women. This study has been possible only because of the work of the Susan G. Komen Tissue Bank at IU Simon Cancer Center (KTB). The KTB has been collecting normal breast tissues from healthy volunteer women for the last 13 years and follows up with the donors about any change in their medical status.

Were you surprised by the results?

Yes, we didn’t expect that the fat cells, which were thought to have only a storage function, play such an important role in promoting cancer development. Further investigation is needed to understand how those fat cells are activated by either genetic or environmental factors (i.e., lifestyle, exposures to pollutions or hormones).

What are the implications of your findings? Are there clinical applications that can be applied in the next few years?

Our findings show the changes leading to cancer develop in the breast long before the cancer is detectable by routine methods. This work provides us with potential “targets” that can be modified to prevent cancer from happening.

AI Disruption of Bioethics

Wed, 14 Oct 2020 00:00:00 Z

Last week, Dr. Eric Meslin, PhD, FCAHS, spoke to the IU Center for Bioethics on the infiltration of artificial intelligence (AI) into healthcare and its potential to wreak bioethical havoc in a presentation entitled, “How Will AI Disrupt Healthcare, and Bioethics?” In this IUCB blog post, I’ll introduce Dr. Meslin, and then discuss his talk.

Dr. Meslin visits us from Canada, where he is President and CEO of the Council of Canadian Academies. He also currently serves as a Senior Fellow for the PHG Foundation at the University of Cambridge, Academic Affiliate at the University of Oxford, and Adjunct Professor at IU McKinney School of Law. From 2001–2016, he served as Founding Director of the IU Center for Bioethics, as well as Dean of Bioethics at the IU School of Medicine (IUSM). While at IUSM, Dr. Meslin also served as Endowed Professor of Philosophy, Professor of Medical and Molecular Genetics, and Professor of Public Health.

Now, for Dr. Meslin’s talk. Undeniably, technology and artificial intelligence are infiltrating healthcare, creating newfangled opportunities for personal patient data analysis, clinical imaging, diagnostics, and health administration workflow. But are these innovations disrupting the health landscape, or are they predictable extensions we have the means to ethically regulate?

To answer this question, Dr. Meslin considers Christensen’s 1997 theory of disruptive innovation, which describes the ability of small, resource-poor businesses to enter markets dominated by larger, incumbent businesses. These small businesses promote new technologies ignored or unstudied by said incumbents (who would rather spend their resources and generate guaranteed profit by bolstering existing technologies). When these new technologies offered by the smaller businesses have become mainstream, they have successfully disrupted established socioeconomic (and, by analogy or extrapolation, healthcare) systems. For a healthcare-specific definition of disruption, Dr. Meslin offers a more modest description: technological disruption occurs when a technology is seen to intersect “with an accepted trajectory of innovation, application, and integration of technology or practice into the delivery of healthcare.” It appears to me that both definitions may generate distinct answers to the question of the current level or potential of disruption of AI in healthcare, depending on the assumptions made by the asker.

For Christensen’s definition, we must be willing to consider established healthcare delivery services an ‘incumbent business’ and patients as customers. We can consider new start-up companies (e.g. 23andMe) to have overtaken certain market niches by selling novel health-related services that classical hospital and healthcare systems do not, thereby generating capital and esteem. To me, this definition of disruption is mostly economic in nature, and presupposes that our bioethical and health infrastructure cannot compensate for the vicissitudes of market capitalism. This discussion raises interesting questions: Can we approximate healthcare as a market, and, if so, how will we ethically regulate upstarts and their services? Besides your standard FDA approval, these unique patient services are not thoroughly vetted. Furthermore, they are not allocated according to any bioethical framework. Should they be? What is the relationship between ethics and free enterprise?

Dr. Meslin’s definition of disruption, that technology essentially outpaces its expected trajectory in the healthcare setting, assumes that our bioethical frameworks are incapable with keeping up with technological advancement, or for some reason that they will soon be unfit to do so. How can we tell if technology is outstripping our ethical framework? Dr. Meslin points to the fact that is takes 10-15 years to fully legislate and evaluate new technologies, but, these days, new technologies are outdated 5-7 years after conception. What does this mean for ethicists? Will a deluge of innovation spark ethical specialization in attempts to keep up? Would specialization fractionate and/or immobilize the current field?

Dr. Meslin raises critical questions for us, as (bio)ethicists, to consider. We need to decide whether our work is enough to sustain contemporary innovation, and how we can maintain or regain our lead. Watch Dr. Meslin’s talk in its entirety here.

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