CHM Flint endowed professor of public health to cap off Spring Brownbag Series

green brownbag and webinar iconSocial Determinants of Behavioral Health

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It is well established that place matters with respect to health and health outcomes. In behavioral health studies of violence, alcohol and other drug use, and mental health, there is growing evidence that environmental risk and social determinants are strong predictors of behavior in highly disordered environments. In fact, they may be more salient predictors of high-risk behavior than individual-level risk factors. The field of health equity research studies the context where people live, work, and play – i.e., where they experience health. Health equity research examines how the environment shapes and influences opportunities for optimal/sub-optimal health and considers related structural and policy interventions to address both built and social environments. Dr. Furr-Holden will provide examples of innovative environmental assessment methods that offer policy-relevant approaches to address the environment and environmental risk. In particular, highlighting policy-based research and implementation efforts in Flint, Michigan and the larger Michigan Department of Health and Human Services Region 5. Such action-oriented research builds on advancements in the field of geographic information systems and offers promising research, service, and advocacy integration in health equity and behavioral health promotion.

April 19 iconJoin us for Dr. Furr-Holden’s lecture on Wednesday, April 19, 2017 from noon till 1 pm in person or online.

Dr. Debra Furr-Holden is a drug and alcohol dependence epidemiologist with expertise in prevention science, psychosocial measurement and behavioral health equity research and interventions. In the last decade her work has focused on developing environmental strategies and structural interventions for violence, alcohol, tobacco and other drug prevention in high-risk settings. Dr. Furr-Holden is the former Director of Prevention for Baltimore City. Dr. Furr-Holden’s research is grounded in the rubrics of epidemiology and psychometrics and consistent with principles and practices for understanding social determinants of health and health equity. Dr. Furr-Holden is a C.S. Mott Endowed Professor of Public Health at the Michigan State University College of Human Medicine Public Health Division.

In person: This lecture will take place in C102 East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? All webinars are recorded! Visit our archive of recorded lectures. To receive reminders before each webinar, please subscribe to our mailing list.

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No More Death Panels; Politically-Assisted Suicide Instead

This post is a part of our Bioethics in the News seriesBioethics-in-the-News-logo

By Leonard Fleck, PhD

Republicans have not coalesced around any comprehensive proposal to replace the Affordable Care Act (though one is now on the table and intensely disputed). This has been named the American Health Care Act. At this writing (March 10) two congressional committees have approved a bill endorsed by Paul Ryan. It is expected to go to the full House this week where it will likely receive a much rockier reception from a number of very conservative Republicans who have derided the bill as “Obamacare Lite.”

For purposes of this commentary I will put aside internal Republican bickering. My goal is to call attention to the most serious ethical deficiencies in the bill as it stands now. I confess that Obamacare Lite does not sound too ethically problematic. Many Democrats would support some reform of the Affordable Care Act. A more accurate moniker (in my judgment) would be “Obamacare Stingy.” That comes closer to capturing the serious injustices inherent in the American Health Care Act (AHCA).

Anyone familiar with my published work knows I am a strong advocate for the view that health care costs need to be constrained, and this needs to be done justly and for the sake of justice in the overall allocation of health care resources. Further, I have argued that those who are medically least well off and capable of significant benefit from access to effective costly health care services have strong just claims to have those needs met. But this is precisely what the AHCA does not do.

Instead, the AHCA eliminates two taxes that Obamacare imposed on the wealthy to pay for the subsidies needed by the poorer uninsured to gain access to insurance. To be precise, the top 1% of income earners in the U.S. (those who earn more than $774,000 in a year) would receive a tax cut of $33,000 while the top 0.1% of earners would get a tax cut of $197,000. In order to reduce the burden on the federal treasury the new subsidies under the AHCA would be given as tax credits and reduced significantly from those provided under Obamacare.* Further, the tax credits would be age-related, not income-related. A 25-year-old would get a tax credit of $2,000 while a 60-year-old would get a tax credit of $4,000. If that 60-year-old earned less than $20,000 under Obamacare, he would have received $9,900 in subsidies for health insurance. The average 60-year-old will have 3.5 times more health care expenses than the 25-year-old. Under the AHCA insurance companies could charge the 60-year-old five times what they charged the 25-year-old, unlike Obamacare which limited that difference to a factor of three. The cost of insurance for that 60-year-old (the silver plan) would be about $18,000 under the AHCA, which would be essentially unaffordable. Instead of the notorious Alaskan “bridge to nowhere,” we would have “subsidies to nowhere.” This is where the most objectionable ethics issues lie: the creation of massive pseudo benefits that provide political cover for members of Congress but no health care coverage for patients with substantial health needs.

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Image description: a woman with white hair wearing a red shirt is displaying a sign that reads, “health care for profit is sick!” Image source: Sage Ross/Flickr Creative Commons

We must also mention that Medicaid funding would be reduced to the states, apparently through a per capita funding mechanism. Over a period of years, the share of Medicaid funding from the federal government would be reduced and the financial responsibility for “adjusting” would be left to state legislatures. The same might be true for high-risk pools for the uninsurable. Again, individuals faced with reduced subsidies would be forced to “freely choose” health plans with very high deductibles, high co-pays, and restricted benefits. This is “fig leaf” insurance, sufficient for political modesty, but insufficient for even modest health care coverage.

The common denominator among these items is reduced federal spending and the shifting of responsibility for making painful cost control (rationing) decisions to states, hospitals, physicians, and individuals. Congress thereby spares itself a Palinesque death panel fulmination. The reason this works is that there are numerous mechanisms for doing rationing invisibly, the most common of which is rationing by ability to pay.** The target for these efforts will be primarily those who are medically and financially among the least well off (not to mention politically powerless), such as our marginally employed 60-year-old above.

If individuals “freely choose” to not purchase health insurance (because it is unaffordable), or “freely deny themselves” needed care (because of high deductibles or co-payments), then responsibility for any bad outcomes (premature death) is widely dispersed among “irresponsible” individuals and effectively rendered invisible to prying media eyes. This is the logic embedded in Representative Jason Chaffetz’s (R-Utah) comment that people should “invest in their own health care instead of getting that new iPhone.” One individual responded that their $117,000 broken ankle was worth 234 iPhones.

A 2012 Families USA study concluded that 26,100 individuals between the ages of 25 and 64 died prematurely in 2010 as a consequence of being uninsured. Of course, the death certificates themselves would not have listed “lack of insurance” as the cause of death. These individuals would have died of their (untreated or undertreated) cancer or heart disease or diabetes, all natural causes, certainly unfortunate, but nothing that would capture any media headlines. These are patients who would have “refused” their life-prolonging $100,000 targeted cancer therapies or their $250,000 left ventricular assist device for their late-stage heart failure. That is what makes these outcomes politically invisible. Patients, apologists for invisible rationing will argue, made the choice to refuse these $100,000 cancer drugs “freely,” which is “better” (for whom?) than mandating and subsidizing their purchase of health insurance. Consequently, Congress and the President are shielded from charges of heartless rationing by a thick political “veil of (willful) ignorance.”

The ethical reality, however, is that this is politically-assisted suicide. If federal funding to the 31 states that have expanded Medicaid to 138% of the poverty level is reduced, and if state legislatures in those states are unwilling to raise taxes to support that former expanded funding, and if taxpayers fail to rise up in revolt and demand higher taxes for compassionate reasons, and if rural hospitals are forced to close because of the size of their uninsured patient base, and if anonymous patients die for lack of timely care and ability to pay, then who should be responsible for “assisting” those deaths?

Judge Neil Gorsuch has made it clear that he is profoundly ethically and legally opposed to physician-assisted suicide. He should be questioned closely at his hearing whether he is equally opposed to the politically-assisted suicides now in the process of being legalized by Republican legislation aimed at replacing the Affordable Care Act. Or will he plead that it is unreasonable to demand that he see what is in reality “invisible”?

Finally, President Trump has committed himself to supporting “universal access” to health insurance. In his tweets he should make clear that such access would be restricted to paytients, who alone seem to have the requisite visibility.

* Lest any of us who are securely in the middle class feel ethically superior to the rich beneficiaries of this tax giveaway, we should be reminded that we were the beneficiaries of $270 billion in tax subsidies in 2016, which reflects the value of the taxes we did not pay on our own health insurance provided by our employers.

** Invisible rationing is intrinsically unjust. The most central element of our understanding of just policies and practices is that they are public, visible, transparent, and available for criticism, most especially by those most directly affected. John Rawls, the philosopher, emphasizes this point in his book, A Theory of Justice. I have argued at length for that same point in the health care context in my book, Just Caring: Health Care Rationing and Democratic Deliberation (Oxford University Press, 2009), chapter 3.

leonard fleck photoLeonard Fleck, PhD, is a Professor in the Center for Ethics and Humanities in the Life Sciences in the College of Human Medicine and the Department of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, March 28, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Dr. Kelly-Blake presents at National Association of African American Studies and Affiliates Conference

Karen Kelly-Blake photoOn February 15-16, Center Assistant Professor Dr. Karen Kelly-Blake attended the National Association of African American Studies (NAAAS) and Affiliates 25th Joint National Conference held in Dallas, Texas. This conference marked the 25th gathering of scholars from across the U.S. and more than twenty countries. Dr. Kelly-Blake’s presentation was titled, ““Danger Talk”: The Covert Costs of Racial/Ethnic Concordance in the Medical Workforce.” The presentation reported preliminary results of a 2000-2015 scoping literature review that examined medical workforce policy strategies for increasing under-represented minorities in medicine. The research is a multi-institutional collaboration with Libby Bogdan-Lovis, MA (MSU), Nanibaa’ Garrison, PhD (University of Washington), Faith Fletcher, PhD, MA (University of Illinois at Chicago), Brittany Ajegba, MPH (MSU), Nichole Smith (Vanderbilt University), and Morgann Brafford, BS (MSU).

Dr. Kelly-Blake discussed the rationales and strategies that are employed to increase under-represented minority (URM) physician workforce capacity. She began by asking the audience to provide reasons for why it would be important to increase URMs in the medical workforce. The top three replies were: communication, cultural sensitivity, and the need to reflect general population demographics. Dr. Kelly-Blake agreed with the audience that these are often the primary justifications provided in the literature. Under-represented minorities (URMs) disproportionately shoulder the burden of care to the underserved, and most often in under-resourced communities. The problem, or the “danger talk” is that selectively placing service expectations not similarly placed on White physician colleagues along with unexamined assumptions of racial/ethnic concordance between patient and physician may place an unfair and unequal burden on URMs. Dr. Kelly-Blake further suggested that such service commitment rhetoric might unwittingly dissuade URM physicians from pursuing research and professional leadership opportunities. In short, welcoming URM physicians into the “house” of medicine, but then limiting their service to the kitchen. Dr. Kelly-Blake concluded that increasing URM physician presence in the medical workforce is indeed admirable and welcomed, but policy initiatives that influence URM’s futures in the medical workforce may have hidden, unanticipated and restrictive consequences.

To learn more about this research, watch the Bioethics Brownbag & Webinar Series talk from Dr. Kelly-Blake, “Covert Costs of Racial and Ethnic Concordance in the Medical Workforce,” recorded on January 18, 2017.

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Do patients have a duty to participate in clinical trials?

bbag-icon-decThe Choice to Become a Research Subject: A First-Person Perspective

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Patients with serious illnesses are often invited to participate in clinical trials. After being diagnosed with advanced cancer, I became one of those patients. I had to choose between two options: a treatment regimen my doctors had recommended, or a trial evaluating different treatments for my disease. As someone who had taught and written about research ethics, and a long-time member of an Institutional Review Board, I was in some ways better prepared than many patients are to make this choice. And I knew about the important health benefits that come from research, as well as the arguments that patients have a duty to participate in research. Nevertheless, I decided not to enroll in the trial. Was this a defensible choice, or did I have a responsibility to contribute to a study that could help future patients in my situation?

March 22 iconJoin us for Rebecca Dresser’s lecture on Wednesday, March 22, 2017 from noon till 1 pm in person or online.

Since 1983, Rebecca Dresser has taught medical and law students about issues in end-of-life care, biomedical research, genetics, assisted reproduction, and related topics. She has been a member of the Washington University in St. Louis faculty since 1998. Her newest book, Silent Partners: Human Subjects and Research Ethics, calls for including experienced study subjects in research ethics deliberations. She is also the author of When Science Offers Salvation: Patient Advocacy and Research Ethics and editor of Malignant: Medical Ethicists Confront Cancer. From 2002-2009, she was a member of the President’s Council on Bioethics and from 2011-2015, she was a member of the National Institutes of Health Recombinant DNA Advisory Committee.

This lecture is co-sponsored by the Program in Medical Ethics, Humanities & Law at Western Michigan University Homer Stryker M.D. School of Medicine.

In person: This lecture will take place in C102 East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

Online: Here are some instructions for your first time joining the webinar, or if you have attended or viewed them before, go to the meeting!

Can’t make it? All webinars are recorded! Visit our archive of recorded lectures. To receive reminders before each webinar, please subscribe to our mailing list.

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Thorny Questions After a French Clinical Trial Goes Wrong

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series

By Hannah Giunta, MPH, PhD

The problem of balancing access to new drugs with the conduct of rigorous clinical trials is not new. Indeed, readers might be interested in checking out a previous Bioethics in the News column that dealt with the right to try novel therapies. But, despite all the coverage, answers are hard to find. The public want access to new therapies that are safe and effective; but, both patients and professionals remain relatively uninformed of how and why the current process operates as it does. While we may rebalance the benefits and burdens of drug development, we can never provide early and widespread access without risk.

During his campaign, President Trump repeatedly promised to eliminate red tape at the Federal Food and Drug Administration (FDA) and speed the approval process for potentially life-saving medications; although, just how he will attempt to accomplish these objectives remains unclear. But, many ethicists are alarmed that current regulations and requirements do not go far enough. Early phase trials are by their design risky propositions. A recent CNN article by Jen Christensen brings these concerns to the forefront. In the article, Christensen highlights the trepidations of several leading ethicists about the current clinical trial process, emphasizing the fact that clinical trial sponsors do not need to provide proof of efficacy in order to begin early phase trials even though the trials can have significant risks for participants. Christensen focuses on a 2016 French clinical trial where six healthy volunteers were gravely injured, and in one case even killed, during a phase 1 trial of a novel painkiller. Previous trials of similar compounds had shown the agents to be clinically ineffective, but the company was not required to show proof of possible clinical efficacy before launching the trial. Ethicists in Christensen’s article suggest that the solution is creating an independent advisory body within the FDA charged with evaluating preclinical evidence of efficacy. Is this a good idea? Possibly, if indeed there is sufficient scientific literature to review and that literature correlates to some degree with efficacy in humans. But, it will not change the necessary step of administering a drug to humans for the first time. No amount of animal testing can establish precisely what will happen in vivo. The very nature of experimentation necessitates a certain level of risk, and early access without risk is impossible.

doctor-holding-stethoscope

Image description: a person’s hands are shown holding a stethoscope. They are wearing a white doctor’s coat. Image source: Alex Proimos/Flickr Creative Commons

In the current system, the FDA focuses on the safety and toxicity of compounds in phase 1 trials before moving on to efficacy assessments in phase 2 and 3 trials. The thought seems to be that toxicity is the first bar to overcome, since efficacy matters little if subjects are harmed by the drug itself. The classic model for phase 1 trials is the dose escalation study where participants are randomly assigned to receive an ever increasing dose of an experimental agent until unacceptable toxicities develop. In the current case, 90 healthy volunteers were recruited for just such a trial. News of a problem was first publicized in January 2016 after one participant was declared brain dead and five others were hospitalized (Bichell, 2016). Medical findings at the time indicated that the previously healthy man who died suffered a massive stroke in his brainstem. Five other men who received an equally high dose of the experimental agent after the first man became symptomatic were also hospitalized. Four suffered headaches, altered consciousness, and short-term memory difficulties (Bichell, 2016).

The question of how the trial went wrong is an indictment and profound misunderstanding of the current system. The investigators gave extremely high levels of the drug in order to determine what dose would be toxic and at what dose the pain receptor in question would be 100% blocked by the agent (Bichell, 2016). In other words, they did it for rigorous scientific reasons in accordance with their approved protocol. The scientific purpose of a phase 1 trial is to establish the dosage level that is toxic. Agents in a phase 1 trial are not dosed as they would be in clinical practice. A second complaint leveled at investigators concerns the fact that similar agents tested in previous trials had failed to markedly reduce pain (Bichell, 2016). Again, these complaints belie a poor understanding of the drug development process. Small differences in chemical structure can make a large difference in pharmaceutical outcomes, and scientists never know when a compound will radically change medical practice. The nature of research means that many drugs will not be successful, but a few will be. A final complaint lodged against the trial investigators suggested that some neurotoxicity in animal studies should have forced scientists to re-evaluate their plan for a phase 1 trial. But, even the scientist lodging this complaint admits that these injuries have happened with other experimental agents (not this particular class of drugs), and those agents caused no problems in human subjects (Bichell, 2016). Of note, the sponsor has made changes regarding how they are notified of subject hospitalization due to concern that additional volunteers received a high dose after the first man was hospitalized.

So, how does what happened last year in France factor into current promises to speed access to new drugs? By scientific standards, the phase 1 trial in question did not fail. It established the outer limits of toxicity. The outcry over what happened in France highlights the differences between how scientists think and how most patients and health care professionals think. Most drugs in the development pipeline will never gain FDA approval. Scientists are concerned with insuring safety and efficacy through a rigorous scientific process that takes time. What is a promising drug today may be a complete flop tomorrow. Expanding access requires that we accept a different standard of evidence (i.e. retrospective clinical data, clinical dosing guidelines without scientifically established maximum doses, etc.). Accepting different standards may make a lot of sense, but it will not mean access without risk. Perhaps the most important step we should take is to test drugs in people who suffer from the disease in question and not healthy volunteers. At least then, the burdens will be borne by those who stand to benefit. Yet, any of these solutions will not change the fact that medical progress is not a straight line, and we are putting people at risk today for the sake of tomorrow.

Hannah Giunta photoHannah Giunta is an eighth year DO-PhD student at Michigan State University. She received her MPH in May 2015 and her philosophy PhD in May 2016. She is currently completing her medical school clerkships and plans to graduate in May 2017.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, March 9, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.

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The Center welcomes Assistant Professor Marleen Eijkholt

m-eijkholt-cropThe Center for Ethics is happy to announce the addition of a new faculty member, Dr. Marleen Eijkholt. Dr. Eijkholt is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Obstetrics, Gynecology and Reproductive Biology. Dr. Eijkholt is also a clinical ethicist for Spectrum Health System.

Dr. Eijkholt was most recently an Assistant Professor in Medical Humanities at Davidson College in Davidson, NC, and Co-Director of Clinical Ethics Consultation Service & Clinical Ethics at Charlotte Medical Center in Charlotte, NC. She received a JD (or LL.B./ LL.M.) from Maastricht University in The Netherlands, and a PhD in Bioethics & Medical Jurisprudence from University of Manchester in the United Kingdom.

Dr. Eijkholt’s research interests include clinical ethics consultation, reproductive ethics, neuroethics, bioethics and human rights; the broad array of ethical, legal and social issues (ELSI) in biomedicine, including rights in reproduction, stem cells, placebos, deep brain stimulation, and rights to experimental interventions. Visit Dr. Eijkholt’s faculty page to learn more about her work.

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Bioethics for Breakfast: The Future of Medicaid and the Affordable Care Act: Ethical and Policy Challenges

bioethics-for-breakfastSteve Fitton and Jane Turner, MD, presented at the Bioethics for Breakfast event on February 2, 2017, offering perspective and insight on the topic, “The Future of Medicaid and the Affordable Care Act: Ethical and Policy Challenges.”

We assume that Republicans in Congress will follow through with their promise to repeal the Affordable Care Act. We also assume that there will be some sort of replacement. The expansion of Medicaid coverage represents just about half the increase in newly insured individuals. The proposal that seems to have the greatest likelihood of being enacted would include block-granting Medicaid. From the perspective of the federal government a block grant is a “fixed budget” as opposed to open-ended funding.

Our speakers discussed what this means for those who are dependent upon the Medicaid program for meeting their health care needs. For example, 31 states have expanded their Medicaid programs to 138% of the poverty level, and 95% of those additional costs are supposed to be covered by the federal government. Will those 31 states have those funds included in their block grant but have it denied to the other 19 states? Is it likely that the size of the block grant will be less than what Michigan would otherwise receive under the current funding mechanism? If the size of the grant is reduced, what sort of health care priorities will Medicaid use to determine the allocation of that more limited funding? What do we imagine might be the consequences for hospitals and or long term care facilities if funding is more constrained? These questions and more were addressed by speakers and attendees during the presentations and moderated discussion.

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Left to right: Jane Turner, Leonard Fleck, and Steve Fitton pose for a photo after the Bioethics for Breakfast event. Photo courtesy of the Center for Ethics.

Steve Fitton
Steve Fitton is a principal with Health Management Associates. He has extensive expertise in Medicaid financing, federal waivers and reinventing healthcare delivery systems. As Michigan’s Medicaid director, he oversaw a budget of more than $15 billion with programs that served over two million residents. Steve played a key leadership role in the approval and implementation of the Healthy Michigan program, the state’s expansion of Medicaid. Steve led the creation and implementation of several Medicaid programs and initiatives to improve access and quality of care while increasing efficiencies and lowering costs. He earned his bachelor’s degree from Michigan State University.

Jane Turner, MD
Jane Turner is a general pediatrician and professor in the Department of Pediatrics and Human Development. She enjoys all aspects of caring for children and youth and has a special interest in working with children who have chronic health conditions. She has served on the faculty of the College of Human Medicine for more than 20 years as a teacher, clinician, and administrator. Dr. Turner also works for the Michigan Department of Health and Human Services as assistant medical director of the Office of Medical Affairs and chief medical consultant for Children’s Special Health Care Services. She went to medical school at the Oregon Health Sciences University and completed a pediatric residency at Children’s Hospital of Pittsburgh.

About Bioethics for Breakfast:
In 2010, Hall, Render, Killian, Heath & Lyman invited the Center for Ethics to partner on a bioethics seminar series. The Center for Ethics and Hall Render invite guests from the health professions, religious and community organizations, political circles, and the academy to engage in lively discussions of topics spanning the worlds of bioethics, health law, business, and policy. For each event, the Center selects from a wide range of controversial issues and provides two presenters either from our own faculty or invited guests, who offer distinctive, and sometimes clashing, perspectives. Those brief presentations are followed by a moderated open discussion.
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