Scott Kim, MD, PhD, is a Senior Investigator in the Department of Bioethics at the National Institutes of Health and Adjunct Professor of Psychiatry at the University of Michigan. Dr. Kim studies research ethics, especially the ethics of involving decisionally impaired persons in research, the ethics of high-risk research, and methodological issues in empirical bioethics research. He is also interested in the interface of conceptual and empirical methods of bioethics scholarship. Prior to joining the NIH, Dr.
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Tanner Caverly, with the support of the Lown Institute, created the Do No Harm Project Competition that asks clinical medical trainees to write vignettes chronicling harm or near harm caused by medical overuse. They announced the inaugural winners in January 2015.
The Center for Bioethics and Social Sciences in Medicine (CBSSM) is supported by the University of Michigan Medical School Dean's Office, the Office of Clinical Affairs, and the Department of Internal Medicine. CBSSM is directed by Dr. Reshma Jagsi, MD, DPhil. CBSSM was established in July 2010 at the University of Michigan Medical School through the merger of the Bioethics Program with the Center for Behavioral and Decision Sciences in Medicine (CBDSM).
The mission of CBSSM is to be the premier intellectual gathering place of clinicians, social scientists, bioethicists, and all others interested in improving individual and societal health through scholarship and service.
CBSSM is a multidisciplinary unit integrating bioethics with key social science disciplines. CBSSM acts as a "home" for anyone interested in applying empirical social science methods to improve health. The primary research interests of CBSSM faculty focus on five overarching themes:
- Clinical and research ethics
- Health communication and decision-making
- Medicine and society
- Health, justice and community
- Genomics, health and society
CBSSM attracts scholars from across departmental and disciplinary boundaries and in so doing, provides fertile ground for new synergies. Our team includes:
- Social and cognitive psychologists
- Behavioral economists
- Clinicians from many specialties
- Decision scientists
- Survey methodologists
- Public health researchers
Currently, CBSSM is housed in the North Campus Research Complex in Ann Arbor. Faculty investigators, project managers, and research associates are supported by a core administrative and financial staff. CBSSM gives considerable attention to training the next generation of interdisciplinary scholars, offering support to junior investigators who can collaborate with seasoned researchers in an umbrella organization.
Because of the high cost of many prescription drugs, some people take fewer pills than prescribed. What are the health implications?
Imagine that four months ago, you started getting chest pains whenever you exerted yourself physically, and at the time you decided this was serious enough to see a doctor. After your doctor examined you and ran some tests, you were told that you have angina, a kind of heart disease. This disease can develop when the coronary arteries become narrow and clogged from high cholesterol and the heart can't get the oxygen that it needs. Your doctor helped you plan some lifestyle changes to treat your condition. You have been very devoted to the new way of life, eating healthier and doing the proper kinds of exercise regularly. Also, part of your treatment involves regularly taking the medication that your doctor prescribed for you. You were told to take one pill each day.
- I would take the pill every day as prescribed.
- I would skip some days to save some money.
How do your answers compare?
You have to save money somehow, right? Perhaps you would just have to cut back on other expenses in your life, but apparently you felt the medication had to be taken as prescribed. Research has found, however, that especially among the elderly, a significant portion of the population reports restricting medications due to cost. An important question is whether this leads to adverse health outcomes. Policy debates have been largely divided on this issue.
Do those who restrict their medications due to cost experience adverse health outcomes?
A research team led by Dr. Michele Heisler and Dr. Kenneth Langa conducted a study to investigate this question. Prior to this study, no one had examined this question by studying the same individuals at different points in time to see if those who restricted medication due to cost were more likely to develop adverse health outcomes. The researchers obtained nationally representative data that was the result of nearly 8000 interviews. Each respondent was interviewed in 1995 or 1996 and then re-interviewed in 1998. At both times, individuals were asked about cost-related medication restriction and about their health. The health questions assessed overall health, angina and other cardiovascular diseases, diabetes, arthritis, and depression.
The researchers found that cost-related medication restriction was associated with almost twice the odds of experiencing a significant decline in overall health. The association between restricting medication due to cost and poor health outcomes was strongest for those who had cardiovascular disease. Of these individuals, those who restricted their medication had a 50% increased odds of suffering angina and a 51% increased odds of having a stroke. Aren't you glad on the previous page you said you wouldn't restrict your angina medication?
Those who had arthritis or diabetes and restricted their medication due to cost did not report worse disease-related outcomes at the second interview. For arthritis, this might have been because of equally effective over-the-counter pain medications, and for diabetes, higher rates of kidney disease would likely require a longer period of follow-up to detect. When looking at age as a factor, the results showed that older adults experienced significant declines in overall health, worse cardiovascular outcomes, and increased depression. The study showed that younger people who restrict are also at risk for a decline in their health.
One limitation of this study is the lack of data about how often individuals restricted medications. If an individual restricted only once or twice, it is not clinically plausible that this would have led to an adverse health outcome. Also, the data on health outcomes were self-reported, and thus subject to bias. Previous studies, however, have shown excellent agreement between medical records and self-reports for conditions such as hypertension, diabetes, and stroke.
Implications on policy
This study provides evidence that, contrary to some claims, adults with chronic illnesses who restrict medications due to cost experience adverse health outcomes. As drug costs continue to escalate and individuals continue to lack full prescription coverage from their health insurance, it will be increasingly important for healthcare systems and physicians to develop strategies to screen patients for cost-related underuse of medications and to provide assistance to these patients. Moreover, insurance companies will need to create benefit packages that provide appropriate coverage, taking into account the cost of prescription medications.
For more information see:
Michele Heisler, Kenneth M. Langa, Elizabeth L. Eby, A. Mark Fendrick, Mohammed U. Kabeto, John D. Piette. The Health Effects of Restricting Prescription Medication Use Because of Cost. Medical Care, 42(7). 2004.
Part of the core mission of the Center for Bioethics and Social Sciences in Medicine (CBSSM) is to extend the ethics education received by medical students and clinicians at the University of Michigan.
Funded by National Institutes of Health
Funding Years: 2015-2018
Institutional Review Boards (IRBs) provide oversight to clinical research involving human subjects to protect participants and ensure ethical research conduct. Local IRBs review research performed just at their own site, while Central Institutional Review Boards (CIRBs) review research being conducted at many sites. Regardless of whether reviews are performed locally or centrally, they must take into account any local context specific to the site where the research will be performed. CIRBs may provide more effective, equitable, and efficient review of large multicenter clinical trials, but whether CIRBs can effectively consider local context is unknown. Local context review is especially important in a kind of research called exception from informed consent for emergency research. In this kind of research, patients who are comatose or otherwise critically ill and unable to consent for themselves may still participate in trials if thir condition is life-threatening and the experimental therapy is only effective if given right away. To perform this kind of trial, researchers must also consult with the community and publically disclose information about the study. Information about those consultations must then be considered by an IRB as part of local context review. The purpose of this project is to explore, revise, and test measures of local context review of community consultation for this type of research, by local and central IRBs. We will work with key stakeholders to identify goals and processes, use these data to develop measures in domains such as trustworthiness and acceptability, and then use these measures to compare local IRB reviews to those of a simulated CIRB for a real trial. This project will be conducted within the Neurological Emergencies Treatment Trials (NETT) network and the Pediatric Emergency Care Applied Research Network (PECARN). These networks will serve as an "empirical ethics lab" in which best practices are developed.
PI(s): Robert Silbergleit
Co-I(s): Michael Fetters, Michael Geisser, Adrianne Haggins, Alan Sugar, Sacha Montas
Scott Roberts, PhD, is Associate Professor of Health Behavior & Health Education at the University of Michigan’s School of Public Health (U-M SPH), where he directs the School’s Public Health Genetics program and teaches a course on public health ethics. A clinical psychologist by training, Dr. Roberts conducts research on the psychosocial implications of genetic testing for adult-onset diseases.
Dina Hafez Griauzde, MD
Robert Wood Johnson Foundation Clinical Scholar
VA Special Fellow, Ann Arbor Veterans’ Affairs Medical Center
Clinical Lecturer, Internal Medicine
Abstract: Greater purpose in life (measured using a validated scale) is associated with lower rates of certain chronic conditions such as cardiovascular disease and stroke. In this seminar, we will discuss the role of purpose in life in the development of prediabetes and type 2 diabetes as well as the potential to augment ongoing type 2 diabetes prevention efforts with strategies that promote greater purpose in life.
I serve as Professor of Family Medicine, Director of Japanese Family Health Program, and Co-Director of the Michigan Mixed Methods Research and Scholarship Program at the University of Michigan. In addition to being a family/general doctor fluent in Japanese, I have long been interested in the influence of culture on medical decision making and ethics, and have conducted numerous health research projects, and published numerous papers in English and Japanese.