Author Archives: IUCB

Tragedy and Choice

As the AP and the Indianapolis Star reported last week, Tim Bowers, a 32-year-old man from Decatur, Indiana, was hunting deer from a tree stand last week and fell 16 feet, breaking his neck and leaving him dependent on a ventilator and most likely paralyzed for life.  The next day, doctors took him off the ventilator to ask him whether he wished to continue, given the likely prognosis, and he chose to stay off the ventilator.  He died a few hours later, surrounded by family and friends.

The story first made local, then national news in large part due to the mixed feelings it engenders.  On the one hand, this appears to be a case where a patient’s doctors respected his autonomy and choice, which many found praiseworthy.  He was asked what he wanted, he answered, and he got what he asked for.  On the other hand, many wonder whether he was responding emotionally or even irrationally to the situation, whether medical professionals at this point could confidently predict his future limitations, and thus whether it was right to “ask the patient” at this time and in this way.  In the end, any opinion about all this involves a large degree of speculation, due to the limited information we have about a largely private event.

In a couple recent interviews with local news stations I said much the same.  Unfortunately, this comes off as the sort of “two-handed philosophy” (“On the one hand…”, “On the other hand…”) that is as common as it is unsatisfying.  But it is also appropriate.  The case of Tim Bowers is truly a triumph of autonomy, a case where he had a chance to make a decision.  In addition, people who knew him have asserted that he was consistent in never wanting to live in a wheelchair. 

At the same time, did he truly comprehend what life as a paraplegic or quadriplegic would be like?  Paraplegics often say that healthy people – or themselves when they were younger and not paraplegic – underestimate the quality of life of a paraplegic.  Was Bowers overwhelmed by the severity of his accident, the life changing and tragic consequences, in a way that clouded his judgment?  Did he have enough information to decide? 

And, at a deeper level, if these were problems with his decision making, then how long should his doctors have waited to ask him what he wanted?  What information should he have been given?  Should he have been kept on a ventilator for weeks or months, perhaps even put though a procedure to create a tracheostomy (a hole in the throat, necessary if a person remains on the ventilator for more than a week or two), before he was deemed to have absorbed enough information, or comprehended his situation, to be able to make a decision?  Down this road lies justice delayed, and thus denied.

The fact that the doctors took out his endotracheal tube as soon as they did suggests that the family may have specifically requested this, to ask him what he wanted sooner rather than later, perhaps because his previously stated wishes suggested that he would not want this. 

While the case is unusual, it raises many of the same questions about autonomy, beneficence, rationality, and informed decision-making that many of us at the Center study in our research and teach in our work with students, doctors, and researchers.  And at its core Bowers’ accident was a tragedy, for a man and his loved ones, and there was no easy answer for how to respect his wishes and thus provide truly “patient-centered” care.

Peter H. Schwartz, M.D., Ph.D.
IU Center for Bioethics

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Follow the Money: The Affordable Care Act, not the Subsidized Care Act


Covering the Uninsured

Like many, I rejoiced at the news of the Supreme Court’s decision upholding the individual mandate and the key provisions of the Patient Protection and Affordable Care Act (PPACA). As a doctor and medical ethicist, I think it is an important step in healthcare reform.

And it is now certain that the presidential election will hinge at least in part on health reform. Voters will have a clear choice on the PPACA: Romney will repeal, and Obama will implement. Which do you want, America?

President Obama and his supporters tout the law’s promise to make affordable health insurance available to many of the 32 million Americans who do not have medical insurance. This is a terrific accomplishment, as are the protections for those who already have insurance, such as eliminating limits on lifetime claims.

At the same time, for the ensuing political debate and the evaluation of the PPACA overall, much more than these accomplishments have to take center stage. Focusing on the uninsured will not win over the electorate. Too many Americans who vote have insurance, and are not fearful about losing it, so the plight of the uninsured is one step removed.

The Elephant in the Room – Cost of Healthcare

Instead, the cost of healthcare is the elephant in the room. The healthcare budget has been increasing faster than the economy for more than 50 years and there is no end in sight. Spending on healthcare now comprises 18% of GDP and continues to grow. Nobody believes that this is sustainable. Democrats and Republicans disagree about how to curb the growth (more on this below) but not that it is necessary to do so.

The growth threatens to upend the federal budget as well as state budgets by causing unsustainable increases in Medicare and Medicaid spending. And it weakens American business. As long as the expense of providing healthcare insurance for your employees is large and growing out of control, it is difficult to hire or to compete with businesses in countries with affordable healthcare.

Obama took on healthcare reform, according to all reports, at least largely because he saw that allowing this growth to continue was simply irresponsible. And he eventually settled on the individual mandate as the essential first step. Once everybody is contributing, and everybody has health insurance, one can start the process of rationalizing and controlling the system.

It would be great if we could control cost without first getting everybody into the system, but that isn’t going to happen. Heck, even Romney knew that when he was governor of Massachusetts, which is why he supported the individual mandate then. The current Republican “proposals” (yes, they do deserve quotation marks) have no hope of achieving this important aim.

The politics

It’s necessary that Obama and other defenders of the PPACA make this argument, and own this aspect of the law, since if they do not, they are ignoring a very real concern about its effect on the budget, at their peril.

Critics of the ACA point out that simply making people join a system that is out of control is like putting your foot on the accelerator of a truck with no brakes. The idea that providing insurance to the uninsured will by itself control costs, by simply getting them to treat health problems before they get serious, is not well supported by the literature. Many preventive measures save lives, but even the best mostly do so at some expense, rather than also saving money.

Instead, Obama and the ACA supporters should be honest that getting everybody (or, almost everybody) insured was simply the first step in controlling costs. Once everybody is in the system, we can make changes that can finally adjust incentives in ways that reward providing essential, cost-effective care rather than providing inessential, expensive care.

As Atul Gawande pointed out in an excellent article in the New Yorker in 2009, the PPACA includes massive numbers of pilot projects to explore ways to improve care and control costs at the same time. Approaches have to include all good ideas, many of which are not possible without a system that includes all possible patients.

As Obama used to emphasize, it’s about finding ways to “bend the curve,” and slow the increase in healthcare spending, not reducing spending from current levels. We don’t have to give up what we have to control spending. In fact, the best way to make sure that we will have to give up what we have is to let prices continue to go up in the future, until even the middle class cannot afford the cost.

But that means that Obama and his team have to explain the sort of mechanisms that we can hope will allow PPACA to lead to truly “Affordable Care” not just subsidized care. They must admit that these mechanisms are still uncertain but at least hold out the best hope of finally controlling costs, to keep the newly insured insured, and to save American medicine.

Can Obama Avoid this Argument?

Some political pundits or advisors will say that Obama should just focus on the easy wins in the law, such as covering the uninsured, eliminating lifetime limits and cost adjustments based on new or pre-existing conditions, allowing young adults to stay on their parents’ insurance, and eliminating the doughnut hole in pharmaceutical coverage for seniors. Why admit that there is a big challenge that comes next, and that the law just sets up the country for having to make decisions to control costs?

The short answer is that you can’t avoid it and addressing the question. Americans know that you can’t get something for nothing. And the size of the federal deficit, and the criticism of federal spending in current discourse, has made it clear that money is not limitless.

If Obama didn’t want to have this discussion, and make this case, he shouldn’t have gone down this road in the first place. It’s “all in” in the poker sense, not just the solve-the-uninsured sense.

Ducking the questions is not honest, and it is not good politics. The discussion of the PPACA must include straight talk about how it will allow us to finally confront and address the ever growing health budget. Above and beyond celebrating the success in covering so many of the insured.

Peter H. Schwartz, M.D., Ph.D.
IU Center for Bioethics

Open Access Week: Bioethics

Here at the Center for Bioethics we are marking Open Access Week by highlighting our free electronic collection, the Bioethics Digital Library (BEDL).

BEDL works to provide access to: out of print books that are now regarded as “classic texts” in bioethics and humanities; court decisions and legislation; government documents; the “gray” literature (unpublished, but authoritative professional literature such as conference abstracts, presented papers, commission meeting minutes); full text of journal articles; and both audio and visual materials.

Popular items in the collection include:

Jennifer Girod and Katherine Drabiak. A proposal for comprehensive biobank research laws to promote translational medicine in Indiana. 5 Ind. Health L. Rev. 217-250 (2008). http://hdl.handle.net/1805/1843

Eleanor D. Kinney, Heather A. McCabe, Amy Lewis Gilbert, Janna Jo Shisler. Altered standards of care for health care providers in the pandemic influenza. IND. HEALTH L. REV. 2009;6(1):1-16. http://hdl.handle.net/1805/2306

Eric M. Meslin and Kenneth Goodman. Biobanks and Electronic Health Records: Ethical and Policy Challenges in the Genomic Age. Indianapolis: Center for Applied Cybersecurity Research, Indiana University. October 2009. http://hdl.handle.net/1805/2129

Ethics guide for health care practitioners: working under conditions of an influenza pandemic. Plan, prepare, practice. http://hdl.handle.net/1805/2010

John E. Sidle. Experiences in Bioethics from Kenya: Equity, Informed Consent, and Community Participation in Research. Second lecture in a series: International Research Ethics. February 23, 2006. http://hdl.handle.net/1805/559

Hosted by the IUPUIScholarWorks repositiory, BEDL is a stable, secure and free place to archive and find bioethics information.

If you would like to contribute an item to the Bioethics Digital Library or have questions about using the collection, contact us at: cntbioet@iupui.edu.

If you would like to search or browse the collection, visit: https://scholarworks.iupui.edu/handle/1805/6

Conference on Infant Mental Health to Focus on Ethics

The Indiana Association for Infant and Toddler Mental Health will hold its 13th Annual Conference on Infant Mental Health on August 12, 2011 at the Riley Outpatient Center at Riley Hospital in Indianapolis. This year’s conference is entitled, “Ethics in Early Childhood Fields: A Moral Psychological Approach.”

The conference features keynote presentations by Darcia Narvaez, PhD and Daniel Lapsley, PhD, both from University of Notre Dame; a presentation discussing ethics in early childhood by Margaret Gaffney, MD, of the IU Center for Bioethics; interactive sessions moderated by IU Conscience Project members; and a panel discussion highlighting practical applications of the information presented throughout the day. Continuing education is available for social workers, psychologist, and physicians (see brochure for details).

Sponsors and partners for this year’s conference include: the Indiana Department of Child Services, Indiana Head Start Collaboration Office, Indiana State Department of Health’s Sunny Start Project, Indiana University School of Medicine, Department of Psychiatry, the Indiana University Conscience Project, the Indiana University Center for Bioethics and the Riley Child Development Center LEND Program.

Please note that you can register by mail/FAX using the form in the brochure OR online through the MHAI website: https://secure.entango.com/donate/MHAIInfTod2011

Attend the Third Annual Teaching Skills in International Research Ethics Workshop

TaSkR IIIThe IU Center for Bioethics and the IU-Moi University Academic Research Ethics Partnership will host its annual Teaching Skills in International Research Ethics (TaSkR) workshop April 12-14 in the Health Information and Translational Sciences (HITS) Building, room 1110.

This workshop will focus primarily on the ethics of research involving human subjects—both behavioral and biomedical—conducted in an international forum, as well as developing stronger pedagogical skills.

The workshop will be attended by over 40 participants plus faculty facilitators.  Participants include faculty who teach within the broad domain of international research ethics, whether this is in the classroom, through lectures, or mentoring students, fellows, and post-docs.  Attendees include faculty who teach in medicine, public health, behavioral science, and a number of liberal arts subjects.  Our guest speakers include: Henk ten Have (University of Duquesne) Peter Schwartz (Indiana University), Margaret Gaffney (Indiana University), Edwin Were (Moi University), Kenneth Goodman (University of Miami), Martin Were (Indiana University), Charles Rotimi (National Institutes of Health), and David Ayuku (Moi University).  We will be joined by Joseph Ali (Johns Hopkins University), Ross Upshur (University of Toronto), Henry Silverman (University of Maryland), and Solomon Benatar (University of Toronto, University of Cape Town). TaSkR will also include an African Fogarty Director’s Roundtable discussion.  We hope this discussion will lead to mutual problem solving strategies and enhance collaboration between the African Fogarty Directors.

There is no cost to attend.  For more information or to register, contact Kalli D. McBride, JD, at kdmcbrid@iupui.edu.

Eric M. Meslin Appointed to IOM Committee

Eric M. Meslin, Ph.D., Director of the IU Center for Bioethics and Associate Dean for Bioethics IUSM, has been appointed to the Institute of Medicine’s Committee on Drug Safety and Post-Marketing Requirements by IOM President Harvey Feinberg. The Committee has been asked by the FDA to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs. Questions to be explored by the committee include:

1. What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?
2. What are the strengths and weaknesses of various approaches, including observational studies, including patient registries, meta-analyses, including patient-level data meta-analyses, and randomized controlled trials, to generate evidence about safety questions?
3. Considering the speed, cost, and value of studies, what types of follow-up studies are appropriate to investigate different kinds of signals (detected pre-approval or post-marketing) and in what temporal order?
4. Under what circumstances should head-to-head randomized clinical trials for safety be required?
5. How should FDA factor in different kinds of safety evidence in considering different kinds of regulatory actions?

The Committee is charged with reporting its findings in March 2011. Complete information including the IOM Committee roster is available at: http://www.iom.edu/Activities/Quality/DrugSafetyPostMarket.aspx

Center News – Spring 2010

Teaching Skills in International Research Ethics (TaSkR) Workshop II
The Second TaSkR Workshop was successfully held February 3rd – 5th, 2010 in Nakuru, Kenya. This workshop was attended by 25 participants and faculty facilitators from both Moi University and Indiana University. The faculty facilitators were from various disciplines; medicine, reproductive health, public health, behavioral science, religious studies, medical education, anthropology, health services research, sociology, bioethics, and linguistics. TaSkR is a feature of the IU-Moi Academic Research Ethics Partnership (funded by grant from the NIH Fogarty International Center). Learn more about TaSkR on our website, at: http://www.bioethics.iu.edu/TaSkR.

International Research Ethics master’s program, Moi University Eldoret Kenya
In February 2010, the Senate of Moi University in Eldoret, Kenya approved a new master’s program in international research ethics. By design, the new program collaborates with a similar graduate level opportunity at IUPUI, the International Research Ethics, MA offered in the Philosophy department. The two programs are a feature of the IU-Moi Academic Research Ethics Partnership (funded by grant from the NIH Fogarty International Center). To learn more about this program, visit our website at: http://www.bioethics.iu.edu/arep.

Biobanks, Bioethics and Sophia University (Japan)
February 23, 2010, the Center for Bioethics hosted a delegation of 8 faculty from Japanese Universities led by Prof. Satoko Tatsui (Faculty of Law Meijigakuin University, Tokyo). The visit had three goals: to discuss ethics and governance on human biobanks and genetic databases in the US and Japan; the policy-making process in various circumstances; and the activities of the IUCB. The visit is a part of the preparatory work that this team is undertaking to establish a center for bioethics at Sophia University. We look forward to the future collaborations that will result from this successful, day-long visit.

Medical Ethics and Professionalism Elective
Indiana University School of Medicine students in their 3rd and 4th years have the option to enroll in a four week ethics elective. IUCB faculty investigator, Meg Gaffney leads this elective with participation from several of the Center’s investigators and affiliates. The most recent course (February 2010) included contributions from Eric M. Meslin, Peter Schwartz, and Kimberly Quaid. The Medical Ethics and Professionalism elective is offered annually in February. Enrollment is limited.

Students may also propose and develop an independent ethics elective or project at any time during the course of their medical studies.

IUCB in the News

Kristen Gerencher. Health reform a hot topic in bioethics circles. MarketWatch. March 19, 2010.
Office of External Affairs. Leadership forum reminds leaders of the power of diversity. Kelley School of Business [News], IUPUI. March 2, 2010.
Marilynn Marchione. AP IMPACT: Testing curbs some genetic diseases. 13 WTHR News. February 21, 2010.
Sound Ethics: How Biobanks Work. Sound Medicine. February 14, 2010.
Molecular Medicine Program Offers Hands-On Research for High School Students. IUPUI News Center. February 12, 2010.
Sound Ethics: Biobanks & Pediatric Research. Sound Medicine. February 7, 2010.

Recent Publications

Jere Odell. Peer-Driven Recruitment: Research Ethics in the Academic Literature. Indiana Bioethics. March 31, 2010.
Jere Odell. Comparative Effectiveness: Research Ethics in the News. Indiana Bioethics. March 15, 2010.
Katherine Drabiak-Syed. Newborn blood spot banking: approaches to consent. PredictER Law and Policy Update. Indiana University Center for Bioethics. March 12, 2010.
Katherine Drabiak-Syed. Transparency of Texas’ NBS Transfer and Reassessing Evasive Statutory Interpretation. PredictER News. March 9, 2010.
Jere Odell. Newborn Blood Spots, Biobanks & the Law: Research Ethics in the News. Indiana Bioethics. February 26, 2010.
Eric M. Meslin. Bank On It. Science Progress. February 25, 2010.
Katherine Drabiak-Syed. Direct-to-Consumer Fetal Sex Prediction Tests: the US is Not Immune to Sex Selection. PredictER News. February 2, 2010.
Research Ethics News Digest – January 2010. Indiana University Center for Bioethics. February 2, 2010.
Peter H. Schwartz. 2009 Walter C. Randall Lecture in Bioethics. Autonomy and consent in biobanks. Physiologist. 2010 Feb;53(1):1, 3-7.
Jere Odell. Autism, MMR, Wakefield and the GMC: Research Ethics in the News. Indiana Bioethics. January 29, 2010.

Recent Presentations

Kimberly A. Quaid. Diagnosis and Disclosure. 2010 Spring Symposium of the Indiana Alzheimer Center, Herron School of Art and Design, Indianapolis, IN. March 20, 2010.
Eric M. Meslin. The Evolution of Bioethics. Darwin Day Science Conference, Center for Inquiry Indiana and IUPUI Freethinkers. March 20, 2010.
Peter H. Schwartz. Mammograms, Decision-Making, and Values. Session: “Evidence in Breast Cancer Screening Decisions: Politics, Policy, and Patient Care,” Bioethics for Breakfast seminar series, Hall, Render, Killian, Heath & Lyman, P.C. and IU Center for Bioethics, Indianapolis, IN, March 5, 2010.
Eric M. Meslin. Science Policy Leadership in a (somewhat) Flat World: Why Bioethics Matters. Fifth Multi-Sector Forum of the Randall L. Tobias Center for Leadership Excellence, Indianapolis, Indiana. February 26, 2010.
Eric M. Meslin. The Underdeveloped Role of Science Policy in Meeting Our Ethical Obligations in Global Health. IU School of Medicine, February 17, 2010.
Katherine Drabiak-Syed. Panelist. Non-Traditional Health Law Careers. Indiana University School of Law- Indianapolis, Indianapolis, Indiana. February 16, 2010.
Kimberly A. Quaid. Ethical Issues in Genetic Testing. The Amelia Project: Giving Wings to Research, University Place Conference Center, Indianapolis, IN. February 13, 2010.
Katherine Drabiak-Syed. Baby Gender Mentor: Class Action Litigation Calls Attention to a Deficient Federal Regulatory Framework for DTC Genetic Tests, Politicized State Statutory Construction, and a Lack of Informed Consent. Predictive Health Ethics Research (PredictER) meeting, Indianapolis, Indiana. January 25, 2010.

Ethics Events

Peter H. Schwartz. Medicine unleashed: eliminating risk and stopping aging. Ethics at Lunch. IU School of Medicine. MS B26. 12:00 – 1:00 PM. April 6, 2010.
Physician Assisted Suicide? End-of-Life Care and Choices: A Discussion on Proposed Legal Changes. Presenters: Barbara Coombs Lee, PA, FNP, JD, and Katherine Drabiak-Syed, JD. Health Law Society. Indiana University School of Law – Indianapolis, Inlow Hall, RM 385. 4:15 PM. April 6, 2010.
Fairbanks Ethics Lecture Series: Ethical Treatment of the Defiant and Disruptive Patient. Michael Webber, MD. Riley Outpatient Center Auditorium, Indiana University School of Medicine, Indianapolis. 12:00-1:00 PM. April 7, 2010.
Seminar in Medical Humanities: The History of Rh Sensitization Disease and Its ‘Cure’. Dr. Peter Marcus, Ob/Gyn. Indiana University School of Medicine, Indianapolis. MS 311A/B.  12:00 – 1:00 PM. April 8, 2010.
Indiana CTSI 2nd Annual Meeting: A Case for Good Governance: Consent, Public trust, Commercialization and other issues for Biobanks. Timothy Caulfield, LL.M. Indiana University School of Medicine, Indianapolis. Health Information and Translational Sciences (HITS) Building. 1:00 – 1:30 PM. April 19, 2010.
Seminar in Medical Humanities: Modeling Life Through Death: Population Histories and the Evidence for Demographic and Epidemiological Change in the Late Prehistoric Midwest. Jeremy Wilson. IUPUI. Room TBA. 12:00 – 1:00 PM. April 19, 2010.
PredictER Meeting: Tailored Therapeutics. Mitchell Klopfenstien and colleagues from Eli Lilly. IU Center for Bioethics, Indianapolis. 3:00 – 4:00 PM. April 26, 2010.
Peter H. Schwartz. Panel discussion of breast cancer screening guidelines. The 2010 Doris H. Merritt, MD Lectureship in Women’s Health, IU National Center of Excellence in Women’s Health. Joseph Walter Hall (R3) Room 203. Indianapolis. 8:15 – 10:30 AM. April 28, 2010.
Fairbanks Ethics Lecture Series: Cultural Diversity/Cultural Sensitivity. Rita Bair, MD, MPH . Indiana University School of Medicine. Riley Outpatient Center Auditorium. Indianapolis. 12:00-1:00 PM. May 5, 2010.

Other Events

Fairbanks Ethics Lecture Series 2009-2010
History of Medicine Speaker Series, 2009-2010 [PDF]
Poynter Center for the Study of Ethics and American Institutions, Spring 2010
PredictER Meetings, Spring Schedule 2010 [PDF]
Purdue Bioethics Seminar Series, Schedule 2009 – 2010