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A number of CBSSM faculty spoke at the recent Michigan State Medical Society Conference on Neonatal and Pediatric Ethics on November 13-14 in Ann Arbor

  • Welcome and Opening & Closing Remarks:  Lauren B. Smith, MD, Chair, MSMS Committee on Bioethics
  • “What’s New at the Margin of Viability?”  Naomi Laventhal, MD, MA, FAAP, Assistant Professor, Pediatrics; Brandon Neonatal Intensive Care, C. S. Mott Children’s Hospital
  • “Elective Operations in Children” Christian J. Vercler, MD, MA, Clinical Assistant Professor, Plastic Surgery; Co-Chair, Pediatric & Adult Ethics Committees; and Co-Director, Clinical Ethics Program, CBSSM
  • “Harms of Newborn Screening: Fact or Fiction?” Beth A. Tarini, MD, Assistant Professor, Department of Pediatrics and Communicable Diseases

Visit this link for more information on the conference.

Give me colostomy or give me death! (Aug-06)

Click to decide between death and living with a colostomy. Which would you choose? Are you sure?

Given the choice, would you choose immediate death,or living with a colostomy (where part of your bowel is removed and you have bowel movements into a plastic pouch attached to your belly)?

  •  Immediate Death
  •  Colostomy

Think about what it would be like if you were diagnosed with colon cancer. You are given the option of choosing between two surgical treatments.The first is a surgery that could result in serious complications and the second has no chance of complications but has a higher mortality rate.

Possible outcome Surgery 1
(complicated)
Surgery 2 
(uncomplicated)
Cure without complication 80% 80%
Cure with colostomy 1%  
Cure with chronic diarrhea 1%  
Cure with intermittent bowel obstruction 1%  
Cure with wound infection 1%  
No cure (death) 16% 20%

If you had the type of colon cancer described above, which surgery do you think you would choose?

  • Surgery 1
  • Surgery 2

How do your answers compare?

In fact, past research has shown that 51% people choose the surgery with a higher death rate, even though most of them initially preferred each of the four surgical complications, including colostomy, over immediate death.

Are you saying what you really mean?

CBDSM investigators Brian Zikmund-Fisher, Angela Fagerlin, Peter Ubel, teamed up with Jennifer Amsterlaw, to see if they could reduce the number of people choosing the surgery with the higher rate of death and therefore reducing the discrepancy. A large body of past research has shown that people are notoriously averse to uncertainty. The investigators had a hunch that uncertainty could account for some of the discrepancy. Surgery 1 has a greater number of ambiguous outcomes, perhaps causing people to be averse to it. In an effort to minimize this uncertainty, the investigators laid out a series of scenarios outlining different circumstances and presentations of the two surgeries. For example the research presented some of the participants with a reframing of the surgery information, such as:

Possible outcome Surgery 1
(complicated)
Surgery 2 
(uncomplicated)
Cured without complication 80% 80%
Cured, but with one of the following complications: colostomy, chronic diarrhea, intermittent bowl obstruction, or wound infection 4%  
No cure (death) 16% 20%

The investigators believed by grouping all of the complications together that people would be more apt to chose the surgery with the lower mortality rate, because seeing a single group of undesirable outcomes, versus a list, may decrease some of the ambiguity from previous research.

Although none of the manipulations significantly reduced the percentage of participants selecting Surgery 2, the versions that yielded the lowest preference for this surgery all grouped the risk of the four possible complications into a single category, as in the example shown above.

Why these findings are important

Over the past several decades there has been a push to give patients more information so they can make decisions that are consistent with their personal preferences. On the other hand there is a growing psychological literature revealing people's tendency to make choices that are in fact inconsistent with their own preferences; this is a dilemma. Because the present research suggests that the discrepancy between value and surgery choice is extremely resilient, much research still needs to be done in order to understand what underlies the discrepancy, with the goal of eliminating it.

The research reported in this decision of the month is currently in press. Please come back to this page in the near future for a link to the article.

Read the article:

Can avoidance of complications lead to biased healthcare decisions?
Amsterlaw J, Zikmund-Fisher BJ, Fagerlin A, Ubel PA. Judgment and Decision Making 2006;1(1):64-75.

 

 

 

Leaving the Emergency Room in a Fog (Sep-09)

Consider this scenario:

Alfred made a visit to his local Emergency Room. What was his diagnosis? What did the medical team do for his problem? What was he supposed to do to continue care at home? And what symptoms was he supposed to watch for to alert him to return to the ER?

Alfred woke up at 4 am on Sunday morning with pain in his left foot. That place where his new running shoes had rubbed a raw spot earlier in the week was getting worse. By 9 am, the foot was red and swollen, with a large oozing sore, and Alfred decided to go to the Emergency Room at his local hospital.

Late on Sunday afternoon, Alfred returned home from the ER. He crutched his way into the house and collapsed on the sofa. His teenage son quizzed him.

"What did they say was wrong?"
"Oh, an infection," replied Alfred.
"Well, what did they do for it?"
"I think they cut a chunk out of my foot," said Alfred.
"Whoa! Did they give you any medicine?"
"Yeah, a shot," said Alfred.
"And what’s with the crutches?"
"I’m supposed to use them for a while," said Alfred, looking annoyed.
"How long a while?"
"It’s written down," said Alfred, digging a crumpled sheet of paper out of his pocket.
"Says here you should take some prescription and elevate your left leg for two days."
"Two days? I have to go to work tomorrow," groaned Alfred.
"And you’re supposed to go back to the ER if you have a fever or pain in your leg. Where’s the prescription?"
"Here, look through my wallet. Maybe I stuck it in there," said Alfred.
The good news is that Alfred recovered completely, with some assistance and cajoling from his son. But how common is it for people who go to the Emergency Room to be foggy about what happened and what they should do once they leave the ER?
What do you think is the percentage of ER patients who do not understand at least one of the following: their diagnosis, the emergency care they received, their discharge care, or their return instructions?
 
  • 38%
  • 48%
  • 78%
  • 88%

How do your answers compare?

A recent study in the Annals of Emergency Medicine found that 78% of emergency room patients showed deficient comprehension in at least one of these areas:
 
  • Diagnosis
  • Emergency care that was given
  • Post-ER care needs
  • Symptoms that would require a return to the ER
51% of patients showed deficient comprehension in two or more areas. Only 22% of reports from patients were in complete harmony with what their care teams reported in all four areas. The biggest area of misunderstanding was in patients' post-ER care needs, such as medications, self-care steps, follow-up from their regular doctors, or follow-up with specialists.
 
Even more alarming is that, according to the study, "most patients appear to be unaware of their lack of understanding and report inappropriate confidence in their comprehension and recall." The patients were quite sure of what they knew 80% of the time—even when what they knew was not right.
 
These results suggest that Emergency Room teams need to do a better job of making sure that patients go home with clear information and instructions—and that patients and their loved ones shouldn't leave until they fully comprehend their situation.
 
Lead author Kirsten G. Engel, MD, conducted this study, "Patient Comprehension of Emergency Department Care and Instructions," with Michele Heisler, MD, Dylan M. Smith, PhD , Claire H. Robinson, MPH, Jane H.Forman, ScD, MHS, and Peter A. Ubel, MD, most of whom are affiliated with CBDSM.
 
The researchers carried out detailed interviews with 140 English-speaking patients who visited one of two Emergency Departments in southeast Michigan and were released to go home. These interviews were compared with the patients' medical records, and the comparisons revealed serious mismatches between what the medical teams found or advised and what the patients comprehended.
 
"It is critical that emergency patients understand their diagnosis, their care, and, perhaps most important, their discharge instructions," says Kirsten Engel, a former UM Robert Wood Johnson Clinical Scholar who is now at Northwestern University. "It is disturbing that so many patients do not understand their post-Emergency-Department care, and that they do not even recognize where the gaps in understanding are. Patients who fail to follow discharge instructions may have a greater likelihood of complications after leaving the Emergency Department."
 
Peter A. Ubel, the study's senior author, agrees: "Doctors need to not only ask patients if they have questions, but ask them to explain, in their own words, what they think is wrong with their health and what they can do about it. And patients need to ask their doctors more questions, and even need to explain to their doctors what they think is going on."
 
Read the article:

 

It is with both sadness and joy that we announce that CBSSM Co-Director Dr. Angela Fagerlin will be assuming a new position as the inaugural Chair of

Population Health Sciences at the University of Utah. While we are very sad to see Angie leave, we congratulate her on this well-deserved opportunity and are thrilled to see her enter this new stage in her career.

Dr. Fagerlin has been with the University of Michigan for 15 years and Co-Director of CBSSM for the last 5 years. She has been an integral member of CBSSM and all its precursors—the Program for Improving Health Care Decisions and The Center for Behavioral and Decision Sciences in Medicine. Dr. Fagerlin will be greatly missed for her friendship, collegiality, mentorship, and the great science she has produced over the years.

As of January 2016, current Co-Director of CBSSM Dr. Raymond De Vries will be joined by Dr. Brian Zikmund-Fisher, who will serve as an Interim Co-Director. Dr. Zikmund-Fisher is an Associate Professor of Health Behavior and Health Education at the School of Public Health, as well as a Research Associate Professor of Internal Medicine. He has been actively involved with CBSSM and its precursors for over 13 years and has many research collaborations and mentoring relationships with CBSSM faculty, fellows, and affiliates. Dr. Zikmund-Fisher looks forward to helping to grow CBSSM's many research and educational initiatives in the future.

Alan R. Tait, PhD

Faculty

Dr. Tait is the Department of Anesthesiology Endowed Professor of Clinical Research. Dr. Tait is a former long-standing member of the Institutional Review Board and a current member of the Medical School Admissions Executive Committee. In addition, Dr. Tait is the Chair of the Research Committee for the Society for Pediatric Anesthesia.

Last Name: 
Tait

Internet Survey Lab

Overview

The Internet Survey Lab at the Center for Bioethics and Social Sciences in Medicine (CBSSM), led by Dr. Brian Zikmund-Fisher, facilitates the programming of complex experimental designs, using the graphical and interactive capabilities of the Internet. CBSSM has extensive experience in developing, programming and conducting survey research using Internet-based methodologies. 

Why We Use the Internet

A key advantage of Internet surveys is that they can shape and direct a user's experience in response to computer generated randomization and/or respondents' own answers to questions earlier in the survey. Additionally, page and answer order can be truly randomized as appropriate to limit cognitive biases. The unique advantage of Internet surveys, however, is that many different types of stimuli can be randomized or varied; static visual images, movies, or sounds can all be used in addition to text. Furthermore, the nature of the browser interface enables user-directed interactivity, such as user-adjustable risk communication graphics, that provide unique opportunities for both knowledge communication and response assessment.

Using the Internet to conduct survey research is also very efficient: we can develop and test surveys in only a few months' time, and once a survey is ready, large scale data collection (e.g., 1500-3000 completed surveys) can be completed in only 2-3 weeks.  Such surveys can also be cost effective, since while significant effort goes into development, creation, and testing of the survey, almost no personnel effort is required for data collection, entering, coding, or cleaning.  In addition, oftentimes several small surveys can be combined into a single instrument, creating further efficiencies.

Sometimes, our studies use large, demographically diverse samples obtained through commercial survey research firms. This methodology allows us to tailor the population being surveyed on multiple demographic variables (e.g., sampling only women age 40-75 for a study about breast cancer treatments) and provides us with ample statistical power to conduct multi-factorial experimental tests. Other times, we use more inexpensive samples from Amazon Mechanical Turk (MTurk) for quick pilot testing or to enable rapid, iterative testing of designs. Regardless, the use of randomized designs ensures high internal validity for the research despite the use of an Internet-only sample.

CBSSM Surveys

CBSSM has had considerable success using this methodology, publishing multiple manuscripts in highly regarded peer-reviewed journals. Studies that have used this methodology have addressed a variety of topics, including:

  • The use of pictographs to display risk (20082008, 2014) including in comparison to other graphical formats (2008, 2010, 2010). 
    Note: to create your own pictographs, see www.iconarray.com.
  • Misprediction of happiness between younger and older adults (2005)
  • Elicitation of utility and willingness to pay (200720072008)
  • Research ethics, e.g., participation of mentally vs. medically ill in research (2005)
  • Risk communications that emphasize incremental risks instead of absolute risks (2008)
  • Simplifying risk communications about adjuvant therapy options (2008).
  • Effect of risk labels on prenatal screening decisions (2007).
  • Time-insensitivity in people's understanding of survival curves (20052007)
  • Self-other discrepancies in medical decisions (20062008)
  • Sequential vs. all at once presentations of risk information (2011)
  • Testing of animated or interactive risk graphics (2011, 2012, 2014)
  • Optimal levels of precision in risk communications (2011, 2012)
  • Framing of health promotion messages (2012)
  • Exploration of role of narratives in decision making (2010)
  • Values Clarification (2015)
  • Intuition and Deliberation in Decision Making (2015)

Contact Us

For questions about our methods or inquiries about potential Internet survey research collaborations, please contact Brian Zikmund-Fisher at bzikmund@umich.edu.

Announcement of Position: Clinician Ethicist

Announcement of Position: Clinician Ethicist


Background
The Program in Clinical Ethics within the Center for Bioethics and Social Sciences in Medicine (CBSSM) represents an expansion of existing services designed to promote a culture of patient-centered excellence by developing a comprehensive set of ethics-related activities. The aims of this program are to: liaise with and provide support to the adult and pediatrics ethics committees; streamline clinical ethics consultation; assist with ethics-related policy development on a regular and proactive basis; organize and administer structured educational programs in clinical ethics; and coordinate empiric research with relevance to clinical ethics within CBSSM.


Program Organization
The Program in Clinical Ethics is co-directed by the chairs of the adult and pediatric ethics committees and consultation services, Christian J. Vercler, MD MA and Andrew G. Shuman, MD. A dedicated clinician ethicist will manage the program on a daily basis. A cadre of eight faculty ethicists will rotate on service throughout the year and work closely with the clinician ethicist. Trainees and students will rotate as well. Dedicated administrative support will be organized through CBSSM.


Position
One individual will serve as the program’s clinical ethicist. This individual will serve as the “first responder” and contact person for all ethics consults during business hours, ensure continuity with consults, and work in conjunction with faculty ethicists. The role will include arranging team/family meetings, ensuring follow-ups on all consults, and arranging additional consultations as needed for selected cases. He/she will also regularly review relevant institutional policies and attend all ethics committee meetings. Another major component of this role will be to organize and participate in educational efforts and preventative ethics rounds. This position will provide $50,000 of direct salary support annually, to be distributed and allocated in conjunction with their home department. The initial appointment will last two years and is renewable.


Qualifications
Candidates are expected to be employees or faculty at UMHS with a master’s or equivalent terminal degree in their field; any professional background is acceptable. Direct experience with clinical ethics consultation is required. Familiarity with ethics education and related clinical research would be helpful. Excellent organizational and communication skills across multidisciplinary medical fields are required. Candidates are expected to have qualifications that meet the standards outlined by The American Society for Bioethics and Humanities (ASBH) for accreditation for clinical ethics consultants.


Application Process
Candidates will be vetted, interviewed and chosen by a nomination committee. Candidates are asked to submit:

  • Curriculum vitae or resume
  • One page maximum summary of (1) education/training related to ethics consultation; (2) clinical ethics consultation experience; and (3) motivation/interest in the position
  • Letter of support from Department Chair/Division Head/Center Director or equivalent
  • Submit formal application via email to: valkahn@med.umich.edu


Timeline

  • Application is due December 11, 2015 with interviews shortly thereafter
  • Appointment will take effect January 1, 2016


Contacts

  • Co-Directors of the Program in Clinical Ethics: Christian J. Vercler, MD MA & Andrew G. Shuman, MD
  • Administrative contact: Valerie Kahn – valkahn@med.umich.edu 734 615 5371

Medical Students

Systematizing the Teaching of Medical Ethics in the Undergraduate Medical Years

Medical students at the University of Michigan encounter ethical issues throughout their four years of training.  Some are obvious – decisions at the end of life, the allocation of scarce of medical resources, challenges to patient autonomy – others are less obvious – relationships between medical residents and medical students, problems with the “hidden curriculum,” and systemic discrimination in the provision of care.  Our goal is to make students aware of the variety of ethical problems in medical care and to equip them to respond to these problems in a wise and responsible manner.

To that end, our curriculum efforts focus on extending the existing curriculum and on making the medical ethics curriculum for undergraduate medical students at UM more systematic and explicit. Because we want students to become well-versed in thinking through ethical dilemmas before they encounter them in their clinical work we weave ethics into the curriculum throughout the 4 years of their undergraduate training. We use the expertise of our CBSSM faculty to create novel curricular components that incorporate our empirical work in bioethics with our particular expertise in decision science.

Increasing Opportunities for Ethics Teaching in the Clerkship Years

Discussions During Required Clinical Rotations

We facilitate regular ethics discussions for medical students at the end of their required clinical rotations in Obstetrics and Gynecology (in the third year) and Emergency Medicine (in the fourth year). To facilitate these discussions, students prepare short essays on ethical dilemmas encountered in these clerkships.  Students are given a summary of all the issues that came up that rotation, which is used as a starting point for a discussion facilitated by a clinical faculty member trained in ethics. In addition, the Internal Medicine subinternship (an option for fourth year students) includes an ethics discussion at the end of the rotation.

These discussions allow medical students to bring up concerns with ethical dilemmas in a safe environment, teach the students about approaches to ethics, and embed training in ethical decision-making in clinical practice. This is often the first time students learn about the role of the hospital ethics committee and how they can contact them if desired.

     “That was unexpectedly awesome!"  

-- Medical student after Ob/Gyn ethics discussion

 

Advanced Medical Therapeutics Ethics Module

All fourth year medical students are required to take an online Advanced Medical Therapeutics course. As part of the course, we created an ethics module that includes multiple cases that present ethical dilemmas.  Each case includes pre-recorded videos of faculty discussing the ethical aspects of the case and interactive components requiring students to choose possible solutions to the problem, after which they receive explanations of the pros and cons of their choice.

Medical Ethics Path of Excellence

CBSSM faculty work closely with the medical school to strengthen the medical ethics curriculum for Michigan medical students.  Our goal is to make students aware of the broad range of  ethical challenges facing 21st century medicine – challenges in clinical care, medical research and the design of health care delivery. Most recently, a team of CBSSM faculty developed the Medical Ethics Pathway of Excellence, an opportunity for students to receive mentored training in ethics throughout their four years of medical school.

Overview of Medical Ethics Pathway to Excellence:

  • Introduced in September 2013, the first 10 students were accepted in 2014. Twelve students joined in 2015.
  • Students apply to the Ethics Path of Excellence at the end of February during their M1 year, and continue their studies through their M4 year. Students in the POE learn to:
    • Identify ethical issues in the organization and delivery of health care
    • Implement tools and strategies to address ethical issues
    • Continue their professional education and development of the skills required for leadership
  • Highlights:
    • Before applying to the Ethics Path of Excellence, students have the opportunity to attend fourteen interactive lunchtime lectures that review various aspects of ethics in a healthcare setting. Applicants must attend a minimum of five of these lectures.
    • Students who want to serve on ethics committees and/or include ethics as part of an academic career are provided with specialized training.
    • All students participate in an individualized, independent study, culminating in a capstone project in the M4 year. Often this work includes field work at CBSSM.

Beginning in 2015, the Path of Excellence has been responsible for administering the core ethics curriculum for all of the M1 students. The Ethics Path of Excellence will continue to be a co-curricular activity until 2017 when all students will be required to choose one of the paths offered in the medical school.

“We really want to educate people to be the ethics committee consultants of the future. I think it's pretty unique to have the option of pursuing this extracurricular program because essentially it teaches you leadership skills and how to be a self-directed learner. These are skills you'll really need when you become faculty. Students can take their interest in ethics and pursue it further.”             
Lauren Smith, M.D., Associate Professor of Pathology

Lauren Smith is the Director of the Path of Excellence. Andrew Barnosky, Christian Vercler, Ed Goldman, Kathryn Moseley, Janice Firn, Sacha Montas, and Raymond De Vries are core faculty members.

Start Seeing Ethics Lunch Discussions

As part of the Medical Ethics Path of Excellence, we offer lunch time discussions of cutting-edge topics in ethics. The content of these discussions includes topics such as conscientious objection, mandatory vs. optional vaccinations, patient centered care and shared decision making.  We have also used these discussions to hold mock ethics committee meetings with discussion of a specific case. Facilitators provide a relaxed atmosphere in which students can feel comfortable asking questions and voicing opinions.

 

"It is exciting to see medical students engage with the ethical issues that arise in the clinic and the classroom.  With encouragement from us they are beginning to see that there is more to medical ethics than just the well-known issues at the beginning and end of life.  While these ethical issues are important, there are also moral consequences associated with the mundane aspects of being a student and working with patients." Raymond De Vries, PhD, Director, Ethics Education Initiative

 

Supporting information for: 2011 CBSSM Research Colloquium

A bureaucratic framework of IRBs: Understanding how cultural forces influence the contemporary IRB bureaucracy

Presenting author: Apurba Chakrabarti, Undergraduate Student, University of Michigan

The Institutional Review Board (IRB) system is almost universally considered dysfunctional. Numerous commentators accuse IRBS of both over-regulation and inadequate protection.  Understanding IRBs within a bureaucratic framework provides a theoretical lens to analyze the genesis and persistence of failings in academic IRBs.  While some authors have used legal approaches, there has been little analysis of the influence of culture on the IRB bureaucracy.  Additionally, there is an absence of literature using the sociology of IRBs approach, where IRBs act as a model to understand bureaucracies in the general terms of organizational theory.  Accordingly, this paper will show that 1) IRBs are a Weberian bureaucracy, 2) a bureaucratic framework of IRBs explain why the contemporary IRB system has a procedural focus and censors research, and 3) IRBs can illustrate new dimensions about how culture influences bureaucracy, as posited in regulation, such as community sensitivity.  This failure is a result of culture-induced goal displacement.  The bureaucratic IRBs respond to the American distrust of government by avoiding real ethics debates and instead have a particularly high focus on more “objective” procedure and paperwork.  Furthermore, a combination of a culture of fear and an expectation of infallible regulatory bodies influences bureaucracies to censor ethically sound, but legally risky research in an effort to protect bureaucratic reputation and prevent legal liability. These examples illustrate how subtle cultural forces influence organizations, as postulated in neoinstitutional theory.  A bureaucratic framework helps address the influence of culture on the IRB bureaucracy, and informs ideas for reform that must not only consider legal and legislative issues, but cultural forces that molded the contemporary IRB system.

Apurba Chakrabarti is a fourth-year undergraduate at the University of Michigan studying cellular and molecular biology.  He is completing an honors thesis in retinal patterning in zebrafish at the Raymond lab in the Department of Molecular, Cellular, and Developmental Biology.  His interests also extend into the social forces influencing the practice of research, including the organization of science and the flaws in the contemporary IRB system.

 

Online sexual racism and the prevalence of HIV among black MSM

Presenting author: Nathaniel Coleman, Graduate Student, University of Michigan

The Sydney-based campaign, www.SexualRacismSux.com, is a unique worldwide campaign against online sexual racism (OSR) among men who have sex with men (MSM).  Sexual racism (SR) is a form of social segregation on the basis of race.  Like all forms of social segregation, SR has two faces: that of exclusion (= spatial segregation) and that of exploitation (= role segregation).  Exclusionary SR consists of the race-based denial of sexual approbation or activity.  For instance, some MSM declare in their online profiles that they are “not into” blacks, or that they will accept “no blacks” for sex.  Exploitative SR consists of the offer of sexual approbation or activity, but only on racially stigmatizing terms.  For instance, some MSM offer sex to blacks only if those blacks fulfill the “ethnosexual stereotypes” of the “Black Mandingo” and the “Savage black top.”  SR reduces a black MSM’s freedom to define himself sexually, for he is restricted to either (a) no sex at all, (b) sex only with others similarly excluded and exploited, or (c) sex only in which he “plays along with” ethnosexual stereotypes.  Option (a) denies a black MSM a basic human function.  Option (b) renders the sexual networks of black MSM relatively more tightly interconnected such that if HIV enters one part of the network, it is likely to spread more rapidly throughout.  Option (c) causes a black MSM who can’t or won’t perform ethnosexual stereotypes to experience low sexual self-confidence.  He is likely to consider himself to have inferior “bartering power” in the marketplace for sex with MSM.  This may cause him (a) to offer unprotected anal intercourse (UAI) as a unique selling proposition, or (b) to give in more readily to demands to engage in UAI.  This argument suggests that those who wish to halt the disproportionately high prevalence of HIV among black MSM should collaborate with www.SexualRacismSux.com.

Nathaniel Adam Tobias Coleman is a doctoral candidate in moral, social, and political philosophy at the University of Michigan.  He is a Fellow at the University of Michigan’s Center for Ethics in Public Life, a member of the Society for the Philosophy of Sex and Love, and a member of the Society for the Scientific Study of Sexuality.  Nathaniel is working under the supervision of Prof. Elizabeth Anderson.  His doctoral dissertation is entitled, The Duty to Miscegenate: From Sexual Racism to Cross-racial Companionship.  

 

Temptation and trespass in the pharmaceutical industry: Incentivizing ethical self-regulation

Presenting author: Henry Greenspan, PhD, University of Michigan

Certain structural features of the pharmaceutical industry are conducive to ethical trespass: the difficulty of developing successful new drugs; the limited time of patent exclusivity; the “blockbuster model” in which most companies rely on a very small number of drugs for a large percentage of annual sales; and the “evidence-free zone” (Gale) between product launch and before many potential adverse effects are shown. Within this business model, companies are induced to “make hay while the sun shines,” and many of the best known ethical problems follow: marketing violations like promotion for unapproved and unproven applications; failure to flag or investigate suspected problems; selective publication; tendentious research design; collusion with corruptible healthcare professionals; and, occasionally, outright data suppression and fraud.  In the meantime, studies show that most external sanctions - including criminal penalties, FDA surveillance, and product liability lawsuits - are relatively ineffective deterrents, and they always arise after the damage is done.  We have no choice, therefore, but to rely primarily on company self-regulation.  A company will always know more, and know sooner, about its products than any external regulator and draconian external sanctions only make it more likely for a company to externalize regulation on to “the cop,” which consistently results in ethical disaster (Braithwaite).  So the question becomes how to positively incentivize companies’ ethical self-regulation.  A number of potential avenues will be suggested, including “perks” like extended patent protection; ethical ratings of companies that have real-world consequences (in preferential contracts with pharmacy benefit managers, for example, along the model of “no sweat” apparel contracts); and the impact of a documented record of ethical excellence on employee productivity and consumer (including physician) loyalty.

Henry Greenspan, PhD, is a psychologist and playwright in UM's Residential College who has been writing and teaching about the Holocaust and other genocides for almost three decades. His most recent book is On Listening to Holocaust Survivors: Beyond Testimony, a second and expanded edition of the 1998 On Listening. This past January he co-led the "Hess Seminar for Professors of Holocaust Course" at the United States Holocaust Museum, the sixth such seminar the museum has offered. He was appointed Fulbright Visiting Research Chair at Concordia University in Montreal for Winter 2012. In between, he has been teaching about ethics, politics, and pharma for the past eight years and organized some of the Health Policy Forum programs on pharma-related topics. 

 

Obstetrician-gynecologists’ objections to and willingness to help patients obtain abortion in various clinical scenarios: A national survey

Presenting author: Lisa H. Harris, MD, PhD, University of Michigan

Co-authors: Farr Curlin, MD, University of Chicago; Ken Rasinski, PhD, University of Chicago; Alexandra Cooper, PhD, Duke University; Anne Drapkin Lyerly, MD, MA, University of North Carolina

Background: Despite debate about abortion ethics and conscientious objection, we know little about obstetrician-gynecologists’ views, or their manifestation in clinical practice.  Methods: We analyzed results of a national survey of 1800 U.S. obstetrician-gynecologists.  We presented respondents with seven scenarios in which a woman sought abortion.  For each, we asked if respondents morally object, and if they would help the patient obtain an abortion.  We analyzed demographic correlates of objection and assistance.  Results: Objection varied by scenario, from 82% in the case of sex selection to 16% in a patient with a potentially fatal cardiopulmonary condition.  Female ob-gyns were more likely to object to abortion in one or more scenarios (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.0 to 2.3). excluding sex selection, objection was less likely in female(OR 0.66, 95% CI 0.49-0.89) and Jewish ob-gyns (OR 0.3; CI 0.1-0.8), and more likely among those practicing in the South or Midwest (OR 1.8, CI 1.2-2.7; OR 2.0; CI 1.3-3.0), who had Catholic or Protestant-evangelical affiliation (OR 2.6, CI 1.6-4.1; OR 4.0, CI 2.4-10), or who indicated religion was fairly, very, or most important in their life (OR 1.7, CI 1.0-2.8; OR 3.4, CI 2.1-5.6; OR 14.9, CI 7-31.4).  With the exception of sex selection, more than 80% would help a patient obtain abortion in all scenarios.  Approximately two-thirds (57-70%) of objecting ob-gyns would help the patient obtain abortion, regardless of scenario.  Excluding sex selection, assistance despite objection was more likely among female ob-gyns (OR 2.1, CI 1.3-3.3), and less likely among those from the South or for whom religion was very important (OR 0.3, CI 0.2-0.6; OR 0.2, CI 0.1-0.6).  Conclusions: Most ob-gyns help patients obtain an abortion even if they have moral objection.  Willingness to help patients varies by clinical context and physician characteristics.

Lisa H. Harris, MD, PhD, is an Assistant Professor in the Department of Obstetrics and Gynecology at the University of Michigan.  She received her MD from Harvard University and completed her residency at the University of California, San Francisco, later obtaining a PhD in American Culture from the University of Michigan.  Dr. Harris has focused her clinical, research, teaching and advocacy career on reproductive justice, reflecting her overarching goal of working at the intersection of medicine, culture, and politics. She also serves on the faculty of the Department of Women’s Studies.

 

The misdiagnosis of the minority problem in cancer clinical trials: Is our focus on medical mistrust causing harm?

Presenting author:  Aisha T. Langford, MPH, University of Michigan

Co-authors: Scott Kim, MD, PhD, University of Michigan

Cancer is the second leading cause of death in the United States and costs the nation approximately $263.8 billion in patient care.  Less than 5% of adults with cancer participate in cancer clinical trials.  Of those who do participate, African Americans are underrepresented despite bearing the greatest cancer burden.  While there are many reasons for lower participation among African Americans, medical mistrust dominates the literature and is often used in reference to the U.S. Public Health Service Syphilis Study at Tuskegee.  Tuskegee did expose structural inequalities and racism in research; however, knowledge of Tuskegee has not been empirically associated with lower enrollment among African Americans, nor can it account for the full range of issues that contribute to medical mistrust.  A person’s experience with the healthcare system and medical providers over time is what increases or reduces trust.  The data suggest that minorities are just as willing to participate in health research when provided equal access.  The Minority-Based Community Oncology Programs and the SELECT trial are prime examples of this.  While mistrust is real, its role may be overstated and a distraction form more pressing issues such as: 1) Access/proximity of clinical trials to minority communities, 2) Patient-provider communication about research, 3) Provider bias in offering clinical trials, 4) Protocol design and eligibility criteria, 5) Better training and rewards for clinical trial faculty/staff, 6)Organizational transparency in research, 7) Community engagement outside of health system walls, and 8) Diversity and cultural competency among healthcare organizations.  Nicholson et al. demonstrated that disparities framed messages have a negative impact on African Americans’ intention to use the healthcare system.  Given this, we should be cautious about perpetuating mistrust assumptions, as they may be causing more harm than good.  Appropriate “solutions” to minority participation are dependent on a correct diagnosis of the underlying problem.

Aisha Langford, MPH, has been the Director of Community Outreach for the U-M Comprehensive Cancer Center since July 2007.  Prior to that time, she held positions in health communications, adult literacy, and public relations.  Ms. Langford holds a Masters Degree in Public Health, Department of Health Behavior & Health Education, from the University of Michigan.  She works with local African American churches and community organizations to implement Body and Soul, a National Institutes of Health/American Cancer Society collaboration to disseminate cancer control interventions.  Ms. Langford also works closely with Cancer Center faculty, staff, and UMHS units as appropriate to enhance health disparities research and participation by under-represented minorities in cancer clinical trials.  She serves on a variety of internal and external committees related to community outreach, minority health, and clinical trials.

 

Innovative therapies in the newborn intensive care unit: The ethics of off-label use of therapeutic hypothermia

Presenting author: Naomi Laventhal, MD, University of Michigan

Co-authors: John Barks, MD, University of Michigan; Scott Kim, MD, PhD, University of Michigan

Neonatologists, like other physicians, are under pressure to use therapies supported by scientific evidence.  In the newborn intensive care unit (NICU) this is an especially thorny issue because seemingly benign but untested treatments have resulted in serious injury, yet the drive to do something for patients at risk for poor outcomes is very strong.  We examine the case of therapeutic hypothermia (TH) for hypoxic-ischemic encephalopathy (HIE), a therapy with demonstrated efficacy for full-term infants in reducing death and disability, but unproven efficacy in pre-term infants.  Clinical trials for pre-term infants are planned; meanwhile guidelines advise against off-label use.  Anecdotal evidence suggests “off-label” TH use may be common.  Here we examine arguments for and against such practices.  Arguments favoring off-label TH use include the lack of alternatives for a disease with terrible outcomes, and the “biologic plausibility” that theses uses TH will be safe and effective. More generally, limiting physicians to therapies supported by randomized control trial (RCT) data would unreasonably constrain clinical practice, and “innovative” practices can be an important driver of progress.  But even if parents are fully informed of the uncertain benefits, this may not be a “nothing to lose” scenario.  Surviving infants treated with off-label TH may have a higher incidence of severe neurologic impairment; this redistribution of poor outcomes may be unacceptable to parents and neonatologists alike.  Premature infants treated with TH may also be more vulnerable to the serious potential adverse effects and have greater mortality. From a societal standpoint, off-label TH use may delay completion or compromise quality of RCTs, resulting in pre-term infants with HIE undergoing risky, ineffective treatment unnecessarily.  We believe that arguments against off-label use of TH are stronger than those favoring it, given the individual and societal risks.  Using this case study, we will discuss a general framework for dealing with “innovative” therapies in the NICU.

Dr. Naomi Laventhal joined the University of Michigan in August 2009, after completing her residency in pediatrics, fellowships in neonatology and clinical medical ethics, and a master’s degree in public policy at the University of Chicago.  In the Holden Neonatal Intensive Care Unit at C.S. Mott Children’s Hospital, she cares for critically ill newborns, provides prenatal consultation for parents expecting to deliver premature infants, and teaches neonatal-perinatal medicine and bioethics to residents and medical students.  Her research is in neonatal clinical research ethics, and her current work focuses on attitudes of parents and health care providers regarding newborn infants as research subjects.

 

Resident attitudes and experience with palliative care in patients with advanced dementia

Presenting author: Erika R. Manu, MD, University of Michigan

Co-authors: Cathy Berkman, PhD, ACSW, Fordham University; Patricia Mullan, PhD, University of Michigan; Caroline Vitale, MD, University of Michigan

Purpose: To explore medical residents’ experience, attitudes and self-perceived confidence about end-of-life care in advanced dementia.  Methods: E-mail survey to all second, third and fourth-year residents in Internal Medicine, Medicine/Pediatrics, and Family Medicine at University of Michigan.  Queried residents’ experience, attitudes and self-perceived confidence approaching end-of-life discussions in patients with dementia, compared to heart failure and metastatic cancer.  Results: Surveys were e-mailed to 120 residents; 61 completed surveys were received after an initial e-mailing and one follow-up email reminder to non-responders, yielding a 51% response rate.  Sixty percent of respondents reported no formal training in estimating prognosis in patients with dementia.  Ninety-eight percent of respondents reported participating in family meetings addressing goals of care in the terminally ill.  Fifty-four percent of respondents agreed they felt confident eliciting patient/surrogate wishes regarding life-sustaining treatments in patients with advanced dementia, with 49% reporting this for patients with heart failure, and contrasting with 84% who agreed feeling confident eliciting wishes in patients with metastatic cancer.  Residents anticipate the need to elicit wishes of patients/surrogates of patients with advanced dementia (67%), heart failure (65%), and metastatic cancer (74%) in their future career. While only 37% feel confident assessing adequacy of caregiver support for their older patients, 82% anticipate they will be required to assess caregiver needs in their future career.  Conclusion: Medicine residents are actively involved discussing goals of care in terminally ill patients.  Despite this experience, they appear to have the lowest confidence in eliciting patient/surrogate wishes in dementia (vs. heart failure and metastatic cancer) and low confidence in assessing caregiver needs, yet believe these skills are important to attain.  These findings elucidate existing educational gaps in resident training and call attention to the need for enhanced education centering on optimal care of patients with advanced dementia.

Dr. Erika Manu is currently a fellow in Advanced Geriatrics at the VA Healthcare System and Clinical Lecturer in the Department of Internal Medicine, Division of Geriatric Medicine, at the University of Michigan.  She graduated from medical school in 1995 from the University of Medicine and Pharmacy, Timisoara, Romania.  She then completed an internship and residency in Physical Medicine and Rehabilitation in Romania before relocating to the United States in 2000.  In 2009, she graduated from the Internal Medicine residency program at St. Joseph Mercy Hospital in Pontiac, MI.  Her interests are focused on developing a career as a clinician educator with a focus on teaching and curriculum development that covers geriatric palliative care concepts in older adults with a strong commitment to the idea of enhancing medical resident knowledge and skills as they care for patients with dementia and other advanced chronic illnesses.

 

Considering virtue: Public health and clinical ethics

Presenting author: Karen M. Meagher, Graduate Student, Michigan State University

As bioethicists increasingly turn their attention to the profession of public health, many candidate frameworks have been proposed, often with an eye toward articulating the values and foundational concepts that distinguish this practice from curative clinical medicine.  First, I will argue that while these suggestions for a distinct ethics of public health are promising, they arise from problems with contemporary bioethics that must be taken into account.  Without such cognizance of the impetus for public health ethics, we risk developing a set of ethical resources meant exclusively for public health professionals, thereby neglecting implications for curative medical ethics and the practice of bioethics more broadly.  Secondly, I will present reasons for thinking some of the critiques of dominant contemporary bioethics can be met by a virtue ethics approach.  I present a virtue ethics response to criticisms that concern 1) increased rigor in bioethics discourse, 2) the ability of normative theory to accommodate context, and 3) explicit attention to the nature of ethical conflict. I conclude that a virtue ethics approach is a viable avenue for further inquiry, one that leads us away from developing ethics of public health in a vacuum and has the potential for overcoming certain pitfalls of contemporary bioethics discourse.

Karen M. Meagher is currently a PhD candidate in the Department of Philosophy at Michigan State University (MSU).  Her interests include public health ethics, philosophy of risk, and virtue ethics.  She previously taught at the University of Michigan-Flint in the Department of Public Health and Health Sciences.  She currently serves on the MSU and State Institutional Review Boards (IRBs) and is employed as a graduate assistant at MSU’s Center for Ethics and Humanities in the Life Sciences.

 

The right not to hear: The ethics of parental refusal of hearing rehabilitation

Presenting author: Andrew G. Shuman, MD, University of Michigan

Co-authors: Serena Byrd, BS, University of Michigan; Sharon Kileny, MD, University of Michigan; Paul R. Kileny, PhD, University of Michigan

Objective: To explore the ethics of parental refusal of auditory-oral hearing rehabilitation.  Study Design: Case study with medical ethical discussion and review.  Methods: Two young brothers present with severe-to-profound congenital sensorineural hearing loss.  The parents, both of whom have normal hearing and work as sign language interpreters, have decided to raise their children with American Sign Language as their only form of communication.  They have chosen not to pursue cochlear implantation nor support the use of hearing aids.  Discussion: This case raises significant questions concerning whether hearing rehabilitation should be mandated, and if there are circumstances in which parental preferences should be questioned or overridden with regard to this issue.  In addition, legal concerns may be raised regarding the possible need to file a report with child protective services. While similar cases involving the deaf community have historically favored parental rights to forego hearing rehabilitation with either cochlear implants or hearing aids, we explore whether conclusions should be different because the parents in this care are not hearing impaired.  Conclusions: The ethics of parental rights to refuse hearing augmentation are complex and strikingly context-dependent.  A comprehensive appreciation of the medical, practical and legal issues is crucial prior to intervening in such challenging situations.

Dr. Andrew Shuman is the chief resident surgeon in the Department of Otolaryngology, Head and Neck Surgery at the University of Michigan Hospitals.  Originally from New York, he is a 2002 graduate with high honors from the University of Michigan’s College of Literature, Science, and the Arts, and graduated with honors in 2006 from the University of Michigan Medical School.  He is pursuing sub-specialized fellowship training in head and neck surgical oncology.  Dr. Shuman has lectured and published in the areas of otolaryngology, emergency medicine, neurosurgery, and medical ethics.  His current research interests include clinical outcomes and ethical issues in head and neck cancer patients.

 

Pathology review of outside material: When does it help and when can it hurt?

Presenting author: Lauren B. Smith, MD, University of Michigan

Purpose: Pathology review is performed for patients when care is transferred to a tertiary care center after diagnostic tissue has been obtained.  While it has many benefits, this practice can lead to unforeseen difficulties in doctor-patient communication and patient well-being, especially if a diagnosis is overturned or modified years after treatment.  The aim of this analysis is to identify clinical situations in which pathology review can result in challenging discussions between patients and oncologists.  Methods: Representative case scenarios are presented in the subspecialty area of hematopathology.  Analysis of the clinical benefits and possible harm to patients, pathologists, and treating oncologists that may ensue from pathology review is performed.  Results: Pathology review may result in a valuable second opinion and expert sub-classification.  However, problematic situations may arise with pathology review, especially if the patient has already undergone definitive treatment and is referred to an academic institution in remission.  Difficulties can also arise when patients do not understand the limitations of diagnosing disease on small biopsies.  The patient may receive a different diagnosis or it may become apparent that the diagnosis could have been made more expeditiously.  These discrepancies must be communicated to the patient and may cause confusion and distress.  Conclusion: Pathology review can be beneficial or potentially harmful depending on the clinical situation.  Preliminary recommendations are provided for selecting cases for review.  Limiting pathology review to certain clinical situations and encouraging patients to get second opinions prior to initial treatment at local referral centers may be helpful in minimizing reassignment of diagnoses after definitive treatment.

Dr. Lauren Smith received her medical degree, pathology residence training, and hematopathology fellowship training at the University of Michigan.  She joined the University of Michigan faculty in 2007.  Dr. Smith is actively involved in the clinical hematopathology services including histopathology, flow cytometry and hemoglobin electrophoresis.  She has been a member of the adult ethics committee since 2005 and she serves on the adult ethics committee consultation service.  Her research interests include ethical issues in pathology.

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