Tag: health care cost

Bioethics for Breakfast: Aducanumab, Alzheimer’s: Having That Conversation

Bioethics for Breakfast Seminars in Medicine, Law and Society

Leonard M. Fleck, PhD, and Irving E. Vega, PhD, presented at the March 24 Bioethics for Breakfast session, offering perspectives and insight on the topic “Aducanumab, Alzheimer’s: Having That Conversation.” Bioethics for Breakfast is generously sponsored by Hall, Render, Killian, Heath & Lyman. This session was the second of a two-part series on the theme “Paradoxes of Aging: Living Longer and Feeling Worse.” The presentation portion of the session was recorded and is available to watch on our website.

Aducanumab, a drug designed to treat Alzheimer’s disease, has been the focus of intense medical, scientific, social, and ethical controversy. The FDA Advisory Commission voted almost unanimously not to approve the drug. The research trials failed to show that aducanumab offered significant clinical benefit to patients in the early stages of Alzheimer’s, and notably the enrollment of Black and Latino patients was disproportionately low. It came as a surprise that the FDA itself ultimately gave its approval to the drug, which costs $28,000 per year and is administered monthly through infusion in a hospital setting.

Fleck provided background on Aducanumab and the clinical trials carried out by the developer, Biogen, that led them to seek FDA approval. He defined the different stages of Alzheimer’s disease, noting that over six million Americans currently have been diagnosed with some degree of Alzheimer’s. Fleck also outlined the FDA’s approval process, including their vote to grant emergency use authorization with the expectation of phase four clinical trials completed within nine years. He also pointed out that Aducanumab’s effects are limited to mild cognitive impairment and mild Alzheimer’s, with no benefit in more advanced stages. However, there have been no other Alzheimer’s disease drugs in the past twenty years with promise of significant benefit.

Bringing up concerns of social justice, Fleck discussed the cost Aducanumab within U.S. health spending, particularly within the Medicare program. It is estimated that 85% of the estimated 3.1 million Americans with a mild Alzheimer’s diagnosis are Medicare eligible, meaning the annual cost to Medicare would be in the hundreds of billions of dollars for the drug and its associated costs. Fleck asked attendees to consider whether this spending would be a just use of limited health care resources.

Vega offered attendees questions to consider: is there sufficient evidence about the safety of the drug? Is there sufficient evidence about the effectiveness of the drug? Does the treatment address health disparities in Alzheimer’s disease? He discussed the biology of Alzheimer’s disease, outlining its effect on the brain, and pointing out what is still unknown about the disease. After defining scientific rigor, Vega walked attendees through concerns about the Aducanumab clinical trials, such as participant age and the inadequate representation of Black, Hispanic, American Indian or Alaska Native, and Native Hawaiian or Pacific Islander populations.

Focusing on these disparities, Vega shared facts pertaining to Black Americans being twice as likely to have Alzheimer’s compared to non-Latino white Americans, and Latino Americans being 1.5 times as likely, compared to non-Latino white Americans. Disparities exist with increased likelihood of comorbidities like stroke, heart disease, obesity, and diabetes. Given these facts, Vega shared concern for observed adverse side effects of Aducanumab, particularly brain swelling, microbleeds, and slow brain bleeding.

Questions from attendees generation discussion about advocacy work, insurance companies, and direct and indirect costs of Alzheimer’s disease. Fleck and Vega noted the cost of care for an individual with Alzheimer’s, in a long term care facility, is typically in the $80,000-$100,000 range per year. Indirect costs include the lost wages of caregivers, and stress experienced by loved ones. Vega also importantly pointed out the context of the approval of Aducanumab: a global pandemic, COVID-19 vaccine development, and the subsequent spread of misinformation. Attendees also participated in polling questions with hypothetical situations, asking whether they agreed or disagreed with the scenarios. Responses were varied, highlighting the complexities of the topic.

Related items

About the speakers

Leonard M. Fleck, PhD, is a professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University. Fleck’s interests focus on medical ethics, health care policy, priority-setting and rationing, and reproductive decision-making. He explores the role of community dialogue (rational democratic deliberation) in addressing controversial issues of ethics and public policy related to emerging genetic technologies. More recently, he has been working on a book-length manuscript that addresses a number of ethical and policy issues related to precision medicine, primarily in a cancer treatment context.

Irving E. Vega, PhD, obtained his undergraduate degree in Biology from the University of Puerto Rico-Mayaguez Campus. He continued his research training in the Department of Cell Biology and Neuroscience at the Graduate School of New Brunswick, Rutgers University, earning his PhD. Vega completed a postdoctoral fellowship in the Neuroscience Department at Mayo Clinic Jacksonville, where he developed his research career focusing on the pathobiology of Alzheimer’s disease. Vega joined the faculty as an associate professor in the Department of Translational Neuroscience at the Michigan State University College of Human Medicine campus in Grand Rapids, MI in 2014. His research focuses on molecular and biochemical mechanisms that modulate the accumulation of pathological tau proteins in Alzheimer’s disease and related dementias. Vega is also working on ethnic disparities and the influence of ethnoracial factors on blood biomarkers in Alzheimer’s disease.

Leonard Fleck presents on cancer care at annual American Society for Bioethics and Humanities conference

Leonard Fleck photo

Last month at the 23rd Annual Conference of the American Society for Bioethics and Humanities (ASBH), Center Professor Leonard Fleck, PhD, presented on “Precision Health, Ethical Ambiguity: How Much Cancer Can We Afford to Prevent?” as part of a session on health care allocation and cost. Dr. Fleck has provided a summary of his presentation below.

“Precision medicine” and “precision health” seem to complement one another. We want an effective targeted cancer therapy for our metastatic cancer, but would rationally prefer to prevent the emergence of a life-threatening cancer–the goal of precision health. In a recent book, The First Cell: And the Human Costs of Pursuing Cancer to the Last, Azra Raza, an oncologist, argues that we are wasting tens of billions of dollars annually on extraordinarily expensive cancer therapies that yield only marginal gains in life expectancy. Raza believes these resources (not resources from heart disease or anything else) should be redirected to destroying cancer in its earliest stages, those “first cells.”

A new liquid biopsy (GRAIL) can detect 50 different cancers in very early stages by examining cell-free DNA at a cost of $800. However, 200 million anxious U.S. adults would be candidates for this test annually at an aggregate cost of $160 billion. From the perspective of health care justice, who should pay for these tests? Who should be denied access to these tests at social expense? Should only individuals with a strong family history of cancer have a moral right to this test at social expense? That would cover only 10% of cancers diagnosed in any given year.

We might say individuals known to be at elevated risk for cancer should have these tests paid for as a social expense. That would include smokers and sun worshippers at risk for lung cancer and melanoma. Would non-smokers and responsible sunscreen appliers have just cause for a grievance, i.e., paying for the irresponsible?

Would justice or efficiency require foregoing $160 billion in metastatic cancer care to pay for this preventive effort? What would a “just enough” balancing of therapeutic objectives look like? The basic economic and ethical problem is that we would be paying $160 billion annually that we knew would yield negative results more than 99% of the time. This is not obviously either a wise or just use of social resources. Moreover, this situation calls attention to the “statistical lives vs. identifiable lives” problem.

The “statistical lives” are the lives we would hope to save from metastatic cancer with the liquid biopsy test. These are nameless and faceless lives, unlike the identifiable lives that are the patients with metastatic cancer who want access to the hyper-expensive targeted therapies that might extend their lives a few months, maybe an extra year or so. In contrast, the hope is that each statistical life saved would result in extra decades of life for that individual.

A key ethical question is whether statistical lives and identifiable lives in this situation are of equal moral weight. Or are the identifiable lives with metastatic cancer more “morally worthy” of social resources because they are suffering and near dying? Or, as Raza contends, are we ethically obligated to shift resources from metastatic cancer patients (who have been effectively treated up to this point) to preventive efforts associated with liquid biopsies hoping to save more lives and life years? How do you, my currently healthy readers, think we ought to decide?

Related reading: If Whole Genome Sequencing is So Cheap and Quick, Why Shouldn’t Everyone Have It Done?

Don’t Scapegoat Immigrants for the COVID-19 Pandemic Surge

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This post is a part of our Bioethics in the News series

By Larissa Fluegel, MD, MHS, and Sean A. Valles, PhD

The U.S. COVID-19 pandemic summer surge has inspired a public search for answers as to why wide vaccine availability has not been sufficient to prevent a new wave of infections. Certain answers are plausible, such as blaming the surge on some combination of the more infectious delta variant spread, vaccination rates remaining too low on average and excessively low for some populations, a relaxation of formal disease control restrictions, as well as more nuanced informal social habits such as diminished mask-wearing, more indoor parties, etc. Yet others cast blame onto a much less plausible target: immigrants.

Florida Governor Ron DeSantis blames President Joe Biden for being too lax on the southern U.S. border immigration enforcement, suggesting that Biden has been “helping [to] facilitate” the pandemic. Governor Greg Abbott of Texas took things further, ordering that state law enforcement could “begin pulling over vehicles whose drivers are transporting migrants who pose a risk of carrying COVID-19.” Both of these responses to the pandemic spread are unethical, incoherent, and ineffectual. Accusations against Latin American immigrants are unethical and misguided.

For many reasons, blaming those immigrants crossing the southern U.S. border for negative health outcomes is problematic. Such targeted blame is dehumanizing to immigrants—it promotes negative stereotypes that perpetuate discrimination, mistreatment and health disparities, and by extension, it is detrimental to non-immigrants’ health. Moreover, it is a form of blame shifting that prevents authorities and the public from effectively taking responsibility for community-wide problems.

Image description: a black and white photo of an individual holding a sign that reads “Hamilton was an immigrant. Einstein was a refugee.” They are wearing a long jacket and a tricorne hat. Image source: Victoria Pickering/Flickr.

Blaming immigrants is dehumanizing

There is a long history of dehumanizing immigrants to the U.S., although such dehumanization is generally done selectively. Immigrants such as Charlize Theron and Albert Einstein are treasured, while others are despised for having the “wrong” skin color, accent, occupations, and so on. Dehumanizing and targeting immigrants has been part and parcel of U.S. history, from 19th century church-burning riots that terrorized Irish immigrants, and the overtly racist Chinese Exclusion Act, to current cases of medical abuse and neglect in migrant detention centers. Philosopher David Livingstone Smith traces these sorts of systemic cruelties to a process of dehumanization in which we find ways of convincing ourselves to think of certain groups of people as somehow less than human. To convince ourselves we seek justifications such as depicting immigrants as vermin infecting or invading a country. According to Livingstone Smith, such depictions then give us permission to act aggressively against those groups and to “exclude the target of aggression from the moral community.”

In sum, we find ways to give ourselves permission to dismiss the ethics of how we treat certain groups of people. With such misplaced permission, we decide that certain groups, in this case select immigrants, don’t count as fellow humans worth caring about, and so abuse doesn’t really count as abuse. It’s this sort of misguided logic that also explains Governors Abbott and DeSantis’ school mask requirement bans. Paradoxically, their purported attempt to reign-in government restrictions on individuals simultaneously reveals disregard for the ways in which harsh immigration enforcement strategies negatively impact the lives of immigrants.

Blaming immigrants promotes unrealistic, unhealthy negative stereotypes

Blaming immigrants promotes negative stereotypes that perpetuate discrimination, social mistreatment, and unjust health disparities. Since early in the pandemic, anti-Asian racism and xenophobia mixed in with COVID-19 politics has led to a worldwide phenomenon of hate crimes against anyone appearing to be of Asian descent, and vicious expressions of misguided blame directed at anyone from the same vague region as where the pandemic originated. Historically, and erroneously, people in the U.S. have associated immigrants with human disease and contagion. Immigration authorities have long scrutinized immigrant health when deciding who can enter or remain in the U.S. Additionally, there is a false perception that immigrant illnesses are predominantly acquired before entry to the U.S.; it is instead most often the case that immigrants tend to struggle with worsening health as they spend more time adopting U.S. cultural norms, including unhealthy eating habits.

Stereotypes about “unsanitary” immigrants represent cruel and unjustified blame shifting. For example, consider meat processing plants which have been hot spots for COVID-19 outbreaks. Staffed predominantly by an immigrant workforce, those workers face abusive and unsanitary working conditions (an open secret in the industry for over a century) that foster disease outbreak. Laying blame for this suffering on immigrant workers, or immigration generally, is a horrendous ethical mistake. Statements by public figures like Governors Abbott and DeSantis contribute to morally skewed views about immigrant health.

Unhealthy negative stereotypes hurt people and cost all Americans a lot of money

Another pragmatic consideration is how those immigrants who do fall ill interface with the U.S. health care system. Negative stereotypes about immigrants among health care providers lead to substandard and/or improper care. In fact, the anticipation of being mistreated coupled with fear among those with an undocumented immigration status serve to dissuade immigrants from seeking needed care. Such fears might even discourage some from getting the COVID-19 vaccine. In this way, blaming immigrants contributes to worsening the pandemic. (A related irony is that nearly 1 in 3 doctors are themselves immigrants.)

There is a public health concern to this sequence. Delaying or avoiding care harms immigrants as well as those around them. To avert transmission, contagious diseases need to be treated in a timely manner. Not doing so leads to an underestimation of actual disease distribution and burden. A correct estimation is necessary to determine the right amount of resources and timely measures necessary to contain them. It is a waste of public resources to have those in need use emergency rooms for care that, if identified and delivered in a timely manner, could have been averted before the situation worsened. Part of the motivation for the Affordable Care Act was to  increase access to regular necessary care, yet undocumented immigrants were excluded from benefitting from the Act, despite the fact that providing coverage would have improved public health and probably saved the public money as well. For example, consider strep throat, a condition that is easily treatable with inexpensive antibiotics. Left untreated, strep throat can get complicated and potentially cause serious long-term heart problems. Untreated strep throat might drive a person to seek care in an emergency department. Yet another example is an untreated dental cavity that might lead to a dental abscess or a deep skin infection of the mouth and neck, again possibly resulting in an emergency room visit. Once there, correct diagnosis would require fluid cultures and expensive MRI or CT imaging. The cost of delayed care is borne by all of us. Some combination of insurance companies, hospitals, or government pay those excess fees, passing along costs to everyone else.

Speaking out

It is unfortunately fashionable across the U.S. and Europe to blame immigrants for social problems. Economic and social problems are quickly blamed on immigrants. Conversely, the available evidence points to immigrants being economically and socially beneficial to their respective new country.

We, the authors, come to this issue as people who have committed their professional lives to making healthcare and health policy more humane—seeking to help our future physicians and our colleagues treat patients as complex human beings deserving of care, rather than revenue streams to be maximized. Similarly, we see immigration discussions falling prey to the same mistake so common in healthcare, wherein powerful decision-makers, such as politicians, lose sight of their shared humanity with the people whose lives depend on them. We need to demand better from our political leaders and importantly, we need to speak out when politicians dehumanize immigrants.

Larissa Fluegel photo
Sean A. Valles photo

Larissa Fluegel, MD, MHS, is an Assistant Professor with the Center for Bioethics and Social Justice and the College of Human Medicine at Michigan State University where she teaches social context of clinical decisions.

Sean A. Valles, PhD, is Associate Professor and Director of the Michigan State University Center for Bioethics and Social Justice. He is author of the 2018 book Philosophy of Population Health: Philosophy for a New Public Health Era (Routledge Press).

Join the discussion! Your comments and responses to this commentary are welcomed. The authors will respond to all comments made by Thursday, September 2, 2021. 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.

Continue reading “Don’t Scapegoat Immigrants for the COVID-19 Pandemic Surge” →

If Whole Genome Sequencing is So Cheap and Quick, Why Shouldn’t Everyone Have It Done?

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This post is a part of our Bioethics in the News series

By Leonard M. Fleck, PhD

The headline in New York Times Magazine reads: “Scientists can now sequence an entire genome overnight.” This is amazing. It took ten years and $3 billion to do the first mapping of the human genome, all three billion base pairs. Today the entire genome of any individual can be mapped for less than $1000. Why is that important? There are preventative, diagnostic, therapeutic, reproductive, and public health reasons. The public health reasons are most evident with the speed with which all the variants of COVID-19 have been mapped.

Having one’s genome mapped can provide an individual with some foreknowledge of health risks to which they might be vulnerable (always keeping in mind environmental factors linked to inherent genetic risks, also keeping in mind the uncertainty and probabilities associated with the vast majority of health risks identified in this way). The risks of medical harm related to genetic ignorance can be reduced. A family of genes referred to as P450 determine whether we are normal, fast, or slow metabolizers of drugs. If we are fast metabolizers, a normal dose will be metabolized too quickly with diminished effectiveness. If we are slow metabolizers, a normal dose will accumulate to potentially life-threatening levels in some cases. Roughly 7% of 1200 FDA approved medications are affected by actionable germline inherited pharmacogenes. Even more importantly, 18% of outpatient U.S. prescriptions (more than four billion per year) are affected by actionable germline pharmacogenomics.

Whole Genome Sequencing (WGS) can assist future possible parents to determine the best reproductive option if they know they represent specific genetic risks to future possible children, e.g., if each were a carrier for a mutated cystic fibrosis gene. In addition, WGS can be used to make accurate diagnoses of very rare disorders that would otherwise require harmful, invasive, diagnostic odysseys. This will be very important in the context of infants in the NICU or children in the PICU.

A technician who has long dark hair and is wearing safety glasses, a white coat, and purple gloves, loads DNA samples into a desktop genomic sequencing machine
Image description:  A technician loads DNA samples into a desktop genomic sequencing machine at the Cancer Genomics Research Laboratory, part of the National Cancer Institute’s Division of Cancer Epidemiology and Genetics (DCEG). Image source: Daniel Sone/National Cancer Institute/Unsplash.

I remind students that unlike normal medical tests that only yield information about the person who has the test, genetic tests tell us about genetic features of a range of close relatives. Hence, if a genetic test identifies a serious health vulnerability in me, that information can be used to alert other family members of that same vulnerability of which they might otherwise have been ignorant (and which might well be medically manageable before clinical symptoms emerge that might then suggest an irreversible disease process). The therapeutic potential of WGS is most evident today in the case of metastatic cancer. WGS can provide base-pair resolution of an entire tumor genome in a single run, thereby revealing the unique mutations and genomic alterations in the cancer tissue. This will often allow the identification of a targeted cancer therapy, such as imatinib, that targets the distinctive genetic features of a cancer, such as chronic myelogenous leukemia.

In the reproductive context WGS can be used as a non-invasive prenatal screening tool to offer a comprehensive assessment of the fetus. Likewise, WGS could be used at birth as a screening tool to offer a more comprehensive assessment of the infant than the current gene panel, which is only looking for fifty-six rare genetic disorders. This increases the opportunities for timely therapeutic interventions, when available.

Given all these potential therapeutic benefits, what would be the potential ethical challenges? Cost is an issue that raises health care justice problems. Though the sequencing itself costs less than $1000, the analysis, interpretation and counseling bring the cost to $3000 (though in the case of cancer treatment the cost will be $10,000). Few health insurers cover these costs. Should access to WGS then be publicly funded, as a matter of health care justice, perhaps as part of a basic benefit package guaranteed to all? If all 330 million Americans wanted WGS, the cost would be $990 billion. Would that be either a wise or just use of limited health care resources, given all sorts of other unmet health care needs in our society?

One of the main rationales for doing WGS is preventive, i.e., to identify significant health vulnerabilities whose risk of actualization can be reduced by behavioral change. However, the critical question is whether we can be very confident that most patients would commit to the required behavioral changes. Available medical evidence suggests pessimism in this regard, which would imply that WGS with this expectation represented a poor use of social resources. No one believes McDonald’s business plans are threatened by WGS.

If WGS is used to replace current neonatal screening practices, are the privacy rights of newborns put at risk, given later in life genetic vulnerabilities that would be revealed? Would these concerns be mitigated if only medically actionable information were revealed to parents, all other information being set aside until that child reached adulthood? However, what exactly is the scope of “medical actionability?” That child might be vulnerable to some serious genetic disorders much later in life. This would not be a concern for the child as a child. But that child might have older relatives for whom this information would have considerable potential relevance. What are the ethical issues associated with either revealing or failing to reveal that information to potentially “at-risk” relatives?

A very important feature of genetic information gleaned from neonatal WGS (and all WGS for that matter) is that the vast majority of that information will be either of unknown or highly uncertain significance. This will be especially true because of the thousands of mutations that would be part of anyone’s DNA. For parents of a newborn, such uncertainty could be distressing for years and years. However, there is also the uncertainty associated with the responsibilities of primary care physicians in this regard. Who is supposed to have responsibility for tracking changes in genetic knowledge regarding those genetic variations in an individual as medical research advances? And who would be responsible for conveying this new information to parents or adult children, and judging what should be told and when? This is a very complex medical information management problem, relative to which current physician complaints regarding the electronic medical record would fade into insignificance.

Let us assume that WGS is going to be done more thoughtfully and more parsimoniously, such as a diagnostic or therapeutic context where such information would be most useful. What will still happen is the discovery of all sorts of incidental genetic information, sometimes with frightening potential consequences. Imagine this bit of medical dialogue: “Mr. Smith, we were looking for the genetic roots of your heart disease (which we found), but we also discovered your genetic vulnerability to an early-onset form of dementia.” Many patients would not want to know this. How is a physician supposed to know what a patient does or does not want to know in this regard?

Finally, WGS could generate new problems of health care justice. Imagine that the incidental finding in the prior paragraph was a 10% lifetime risk of some serious but treatable cancer. I personally would not be especially distressed by such a finding. However, other individuals might be especially anxious and demand all manner of expensive diagnostic tests on a semi-annual basis to rule out any indications of disease initiation. Would that individual have a just claim to such resources at social expense?

To return to the title of this essay, perhaps the fact that WGS is quick, easy to do, and relatively inexpensive is insufficient reason to justify the promiscuous promulgation at social expense of this technology. Perhaps more thoughtful social and professional deliberation regarding the issues identified in this essay would yield less ethically fraught uses of WGS. Then again there could be the 2030 version of the electronic medical record with room for terabytes of genetic information and thousands of new tabs and subtabs!

Leonard Fleck photo

Leonard M. Fleck, PhD, is Professor in the Center for Bioethics and Social Justice 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 Thursday, May 6, 2021. 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.

More Bioethics in the News from Dr. Fleck: Religious Coercion of Physicians: Whose Conscience Is It Anyway? Health Care and Social Justice: Just Take Two Aspirin for Your Tumor If You Cannot Afford Your Cancer Care; Medicare For All: This Is Going to Hurt; Greed Is God: The Divine Right to Avaricious Drug Pricing; Gene Editing: God’s Will or God’s Won’t

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Listen: Why I Left the U.S. for My Surgical Procedure

No Easy Answers in Bioethics logoNo Easy Answers in Bioethics Episode 21

What would you do if you needed surgery, but seeking care would mean $25,000 or more in medical debt? Would you consider traveling to another country to receive the same surgery at a fraction of that cost? Would you put off seeking care entirely, until it became an emergency situation?

These questions related to access to care, health insurance, and medical tourism are explored in this episode, which features Center for Ethics and Humanities in the Life Sciences faculty members Len Fleck and Larissa Fluegel. Dr. Fluegel, a clinician born and raised in the Dominican Republic, shares her personal experience of needing gallbladder surgery, and the reasons why she traveled from Michigan to the Dominican Republic to receive that surgery. It may not be surprising that the main reason was cost. Discussing the healthcare systems in both countries, Drs. Fleck and Fluegel explore the challenges that under- and uninsured individuals in the U.S. face when seeking care.

Ways to Listen

This episode was produced and edited by Liz McDaniel in the Center for Ethics. Music: “While We Walk (2004)” by Antony Raijekov via Free Music Archive, licensed under a Attribution-NonCommercial-ShareAlike License. Full episode transcript available.

About: No Easy Answers in Bioethics is a podcast series from the Center for Ethics and Humanities in the Life Sciences in the Michigan State University College of Human Medicine. Each month Center for Ethics faculty and their collaborators discuss their ongoing work and research across many areas of bioethics. Episodes are hosted by H-Net: Humanities and Social Sciences Online.

Bioethics for Breakfast: Can Pharmaceutical Cost Control Be Achieved Ethically with Surgical Precision?

Bioethics for Breakfast Seminars in Medicine, Law and SocietyPaula Cunningham and Craig Hunter presented at the February 6th Bioethics for Breakfast event, offering perspectives and insight on the topic “Health Reform: Can Pharmaceutical Cost Control Be Achieved Ethically with Surgical Precision?”

This year’s Bioethics for Breakfast series is focused on a central theme: “Is There a Cure for Our Sick Health Care System?” The series is generously sponsored by Hall, Render, Killian, Heath & Lyman.

There is virtually unanimous agreement among health policy analysts that something must be done to control health care costs, especially pharmaceutical costs, which are often a major burden for the elderly. Consumers and taxpayers are also demanding that health care costs be controlled and reduced, most often with regard to drugs. This is why the recent focus has been on the price of drugs. However, any practical proposal to reduce drug health care costs has been denounced as rationing and/or as a threat to medical innovation. The result has been political inertia and economic exuberance (for for-profit health care corporations), with $3.8 trillion in U.S. health spending in 2019 and projections of $6.0 trillion total health spending for 2027. What forms of drug-related health care cost control are you willing to accept for yourself and those you care about? What do you see as the ethical challenges that must be addressed by any effort to control such health care costs, especially for the elderly?

Speaker Paula Cunningham, State Director of AARP Michigan, highlighted the struggles that people in Michigan face regarding the price of prescription drugs, noting that some individuals travel to Canada because the cost there is drastically lower. Cunningham shared the AARP “Stop Rx Greed” campaign as an example of their advocacy work in this area. She also noted that there are several pieces of legislation being worked on in Michigan and at the national level, such as an importation bill, that would reduce prescription drug costs. She finally stressed that this issue is not just about data and facts, it is about people’s lives.

Speaker Craig Hunter, Director of Specialty Program Outcomes and Analytics for CVS Health, brought industry expertise to the discussion and provided an economic perspective on the issue. He shared three main points, the first being that we need to rethink the question “can medical outcomes be achieved ethically with surgical precision?” because economic structures in the U.S. are not set up in a way that drives synergy. Hunter then discussed the need for structural changes to encourage creative solutions. When asking those in attendance if they believed that drugs in the U.S. are a public good, a minority responded in agreement. Hunter pointed out that this question has been answered very differently in other countries. Finally, Hunter noted that, regardless of “right or wrong,” the market is responding to its own stimulus; the business has been incentivised for certain outcomes.

Attendee questions and comments came from a variety of perspectives, including physicians, legislative staff, and community leaders. There was discussion of direct-to-consumer advertising, drug patents, and the barriers that exist for the consumer within this complex system.

About the Speakers

Paula Cunningham
Paula Cunningham, MLIR, is State Director of AARP Michigan, which has more than 1.4 million members. She is former President of Lansing Community College, and in the business community was CEO of Capitol National Bank. She serves on numerous boards, including, but not limited to, Davenport University and McLaren Health Systems-Lansing. Paula is in the Michigan Women’s Hall of Fame and was the first African American woman in the country to be president of a majority owned bank.

Craig Hunter
Craig Hunter is the Director of Specialty Program Outcomes and Analytics for CVS Health, providing leadership and oversight for outcomes-based financial reconciliations negotiated across specialty drug and patient management products. Previously Craig worked at Eli Lilly, first as the Lead Outcomes Scientist for the U.S. Alzheimer’s and Oncology franchises, and later leading U.S. Outcomes Customer Engagement. Additional previous experience includes time consulting as well as Primary Investigator for a USAID-funded project examining the intersection of traditional and western medicine in South Africa. Craig earned his MPP from the University of Chicago and a BA in Communications (Rhetoric)/Political Science from Furman University.

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.

Listen: Ethics and Policy Issues of Targeted Cancer Therapies

No Easy Answers in Bioethics logoNo Easy Answers in Bioethics Episode 16

What kinds of challenges currently exist within precision medicine? This episode focuses specifically on targeted cancer therapies, featuring a discussion between Center Professor and Acting Director Dr. Len Fleck and College of Osteopathic Medicine student Stephanie Mackenzie. Dr. Fleck discusses ethics, economic, medical, and health policy issues related to these high-cost therapies. Additionally, he provides insight into how U.S. pricing models for these therapies compare with other countries.

Ways to Listen

This episode was produced and edited by Liz McDaniel in the Center for Ethics. Music: “While We Walk (2004)” by Antony Raijekov via Free Music Archive, licensed under a Attribution-NonCommercial-ShareAlike License. Full episode transcript available.

About: No Easy Answers in Bioethics is a podcast series from the Center for Ethics and Humanities in the Life Sciences in the Michigan State University College of Human Medicine. Each month Center for Ethics faculty and their collaborators discuss their ongoing work and research across many areas of bioethics. Episodes are hosted by H-Net: Humanities and Social Sciences Online.

Health Care and Social Justice: Just Take Two Aspirin for Your Tumor If You Cannot Afford Your Cancer Care

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

By Leonard Fleck, PhD

Dr. Stanley Goldfarb is the former Associate Dean of Curriculum at the University of Pennsylvania Perelman School of Medicine. In a recent Wall Street Journal opinion piece, “Take Two Aspirin and Call Me by My Pronouns,” he complained that curricula in medical schools “are increasingly focused on social justice rather than treating illness.” He goes on to say, “A new wave of educational specialists is increasingly influencing medical education. They emphasize ‘social justice’ that is related to health care only tangentially.” Really? Only tangentially?

Readers will recall Dr. Mona Hanna-Attisha, a pediatrician in Flint, Michigan. She had discovered elevated lead levels in many of her pediatric patients. She could have “stayed in her lane,” provided chelation therapy, hoped for the best, and gone home for dinner. If this is what we would have taught her during her medical education, we would have been complicit in suborning a major injustice.

Dr. Hanna-Attisha did the necessary background research, discovered that public officials had switched the source of Flint’s drinking water to save money, which, in turn, resulted in lead being leached into the drinking water. She brought her case to the media and vigorously advocated (successfully) for correcting this health hazard. She did this for the sake of the children in Flint, many not yet born. This was not tangential to her role as a physician; this was integral and essential. This was a matter of social justice. This was part of her medical education in the College of Human Medicine.

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Image description: Dr. Mona Hanna-Attisha is seated at a table smiling. Image source: University of Michigan School for Environment and Sustainability/Flickr

The practice of medicine today is suffused with social justice challenges. As we explain to our first-year medical students, the clinic is not an island of “pure caring,” isolated from the injustices that are pervasive in our health care system and governing policies. Those injustices frequently seep into clinical practice through the hands of physicians who, no doubt, see themselves as just and caring practitioners. This may sound like hyperbole, but I ask you to consider the evidence.

For the past forty years the dominant demand in health policy has been for health care cost containment. I will remind the reader that last year in the United States we spent $3.65 trillion on health care, roughly 18% of our GDP, compared to 11% of GDP in most European nations. If we ask who is responsible for spending more than 70% of those dollars, the short answer is that physicians in the clinic are the responsible agents. Physicians decide whether a patient needs surgery, which drugs to prescribe, what diagnostic tests are necessary, how much home care is needed, and so on. Consequently, if a focal point is needed for controlling health care costs, it will be physicians.

Note that cost control can be a matter of justice or injustice. In either case, physicians will have to be mindful of the justice-relevant consequences of their diagnostic or therapeutic choices. In the 1990s a number of managed care plans used “at risk” reimbursement to elicit more cost-conscious physician clinical behavior. In some cases, as much as 30% of a physician’s income could be “at risk” if they ordered too many tests. They could also earn 30% bonuses if they were especially stingy in their use of tests. Patients knew nothing of these arrangements. Income risks and opportunities such as those could readily shape physician behavior in ways that were less than just. Whether physician judgment in these circumstances would be corrupted would depend upon whether in their medical education they had had the opportunity to reflect upon such future challenges (as opposed to thoughtlessly accepting such practices as “this is the way medicine is practiced today.”)

Putting physician income at risk to control costs related to patient care is crude and obvious. More problematic are the subtle and invisible ways in which physicians control costs justly or unjustly. For example, a patient demands an MRI to rule out brain cancer when a physician is medically certain these are tension headaches. But the physician authorizes the MRI because “insurance will pay.”

If thousands of physicians are indifferent to authorizing such unnecessary care, then the costs of health insurance to employers increase. For employers at the economic margins, that cost increase may mean dropping health insurance as a benefit, thereby adding those employees to the ranks of the uninsured. From the perspective of any individual physician, this is a very remote, invisible consequence of their decisions that creates an injustice. Medical students need to know this to practice medicine justly.

Other employers will change insurance coverage to reduce their costs. They will require their employees to accept insurance with $5000 front-end deductibles. Financially less well-off workers will deny themselves that unnecessary MRI (no injustice there), but they will also deny themselves medically necessary diagnostic procedures (sometimes with deadly consequences) by not even walking into a physician’s office. Why, physicians might ask, should they as physicians be responsible for those bad decisions by patients; there was nothing to diagnose in the examining room. But maybe there was something to diagnose in society? This is sounding a bit more like the situation in Flint. Non-physicians made cost control decisions but counted on physicians to see such decisions as “merely tangential” to the practice of medicine, nothing that should concern them.

Precision medicine has generated more than 90 FDA approved genetically-targeted cancer drugs with annual costs of more than $100,000. These drugs are used with patients with metastatic disease. The vast majority of these patients will gain no more than extra months of life from these drugs, not extra years (though clever media campaigns create a very different impression). For most workers, their health plan will require a 20-30% co-pay for these drugs, which is unaffordable for most workers. Financially well-off managers and executives will be able to afford those co-pays, which means that workers who could not afford the co-pays will have contributed through their premiums to subsidizing that other 70-80% for the well-off. Is that fair? Is that just?

Should physicians caring for these patients silently acquiesce to these insurance arrangements as “too tangential” to medical practice, too far removed from the clinic? Should we, as teachers of future physicians, also silently acquiesce so that more curricular time can be allocated to understanding the mechanisms of action of the next 90 FDA approved targeted cancer therapies? WWHAD: What Would Dr. Hanna-Attisha Do?

Leonard Fleck photoLeonard M. Fleck, PhD, is Acting Director and Professor in the Center for Ethics and Humanities in the Life Sciences and Professor in 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 Thursday, October 24, 2019. 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.

More Bioethics in the News from Dr. Fleck: Medicare For All: This Is Going to Hurt; Greed Is God: The Divine Right to Avaricious Drug Pricing; Gene Editing: God’s Will or God’s Won’t

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New health care justice article from Dr. Fleck in ‘Cambridge Quarterly of Healthcare Ethics’

Leonard Fleck photoCenter Acting Director and Professor Dr. Leonard Fleck has an article in the July 2019 issue of Cambridge Quarterly of Healthcare Ethics. “Precision QALYs, Precisely Unjust” addresses issues of health care justice and cost effectiveness.

Abstract: Warwick Heale has recently defended the notion of individualized and personalized Quality-Adjusted Life Years (QALYs) in connection with health care resource allocation decisions. Ordinarily, QALYs are used to make allocation decisions at the population level. If a health care intervention costs £100,000 and generally yields only two years of survival, the cost per QALY gained will be £50,000, far in excess of the £30,000 limit per QALY judged an acceptable use of resources within the National Health Service in the United Kingdom. However, if we know with medical certainty that a patient will gain four extra years of life from that intervention, the cost per QALY will be £25,000. Heale argues fairness and social utility require such a patient to receive that treatment, even though all others in the cohort of that patient might be denied that treatment (and lose two years of potential life). Likewise, Heale argues that personal commitments of an individual (religious or otherwise), that determine how they value a life-year with some medical intervention, ought to be used to determine the value of a QALY for them. I argue that if Heale’s proposals were put into practice, the result would often be greater injustice. In brief, requirements for the just allocation of health care resources are more complex than pure cost-effectiveness analysis would allow.

The full text is available online via Cambridge University Press (MSU Library or other institutional access may be required to view this article).

Patient dumping: why are patients disposable?

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

By Karen Kelly-Blake, PhD

A public uproar ensued when a video revealed hospital staff literally dumping a woman wearing only a gown and socks in frigid weather on the streets of Baltimore. Imamu Baraka, a psychotherapist, witnessed the incident and recorded it on his cellphone. In the video, we see Mr. Baraka questioning the security personnel about their activity, and then we see them silently walking away.

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Image description: a crumpled hospital gown is pictured on the edge of a concrete ledge. The background is a concrete sidewalk. Image source: Lynn Park/Flickr Creative Commons.

The fact that the public appeared to be surprised by this event was bewildering. Patient dumping is hardly a new phenomenon, and in fact, it should not come as a surprise that those being dumped in this fashion are predominately non-white, poor, homeless, mentally ill, uninsured, and drug users. So, what is patient dumping? It is when hospitals that are capable of providing necessary medical care fail to screen, treat, or appropriately transfer a patient, or alternatively, when they turn the patient away because of the patient’s inability to pay for services.

Hospitals have long relied on this tactic as a way to offset care for those patients who cannot cover their costs, and so the hospital then is not reimbursed—it is an economic profit-loss decision. But, this blog is not about blaming hospitals. It is about recognizing that patient dumping is a symptom of larger healthcare system and societal ills. Consider the following:

Thirty million people in the U.S. remain uninsured after Affordable Care Act (ACA) implementation. Forty million adults experience mental illness in a given year. 554,000 people in the U.S. are homeless. Forty-three million live in poverty. Every day, the opioid epidemic claims 175 lives. These many data points speak to the U.S.’ combined lack of healthcare and social safety nets. Filling those gaps alone could potentially avert patient dumping.

By default, public, not-for-profit hospitals are charged with caring for such vulnerable patients. In the era of value-based, pay-for-performance, and accountable care organization (ACO) reimbursement models, those hospitals consequently will struggle to meet Centers for Medicare & Medicaid Services quality care metrics.

Federal legislation such as the Hill-Burton Act and later the Emergency Medical Treatment and Labor Act (EMTALA) were instituted to address legal and ethical concerns about patient dumping. Signed in 1946 by President Truman, Hill-Burton directed hospitals to make services available to anyone living in the geographic region of the hospital and to provide care free of charge to those individuals unable to pay. Signed in 1986 by President Reagan, EMTALA was enacted to protect all individuals seeking treatment at Medicare-participating hospital emergency departments. In addition to federal statutes, states also have passed legislation requiring hospitals to provide care irrespective of ability to pay and require that patients be medically stable before transfer. Regrettably, federal and state laws have not performed as was intended. Statutes designed to prevent patient dumping are criticized for 1) having narrow and unclear definitions of what constitutes a medical emergency; 2) failing to clarify what it means to stabilize patients before a transfer; and 3) failing to adequately provide the means for monitoring and enforcement (Ansell & Schiff, 1987).

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Image description: An aerial photo of a medical waiting area shows rows of blue chairs, and three seated individuals dispersed throughout. Image source: Erwin Morales/Flickr Creative Commons.

It would seem that patient dumping is symptomatic of larger macroeconomic and macrosocial issues. What possible solutions exist?

Suppose we actually provided health care to everyone? The ACA has greatly expanded insurance coverage by extending Medicaid, but many people remain uninsured due to prohibitive costs. Imagine having access to health insurance that was not employment dependent. Imagine that people with mild, moderate, and severe mental illness received comprehensive health services. Imagine a system of care that recognized that social determinants of health profoundly influence health outcomes. Imagine having food assistance folded in as part of a medical treatment.

Suppose we eradicated poverty and homelessness? Imagine a time when people could actually support themselves and their families because they made a living wage. Imagine that support was available for people to simultaneously work and pay for childcare.

Suppose we actually utilized comprehensive discharge planning for patients? Imagine planning documents that were easy to read and comprehend because health literacy was important. Imagine patients understanding the medications they needed to take when they got home. Imagine that prior to discharge patients had appointments scheduled for follow-up visits and had the transportation in place to get them there. Imagine providing support visits for elderly patients to make sure they were living in decreased fall risk environments.

Suppose we made the profession of medicine responsible for caring for our most vulnerable—the sickest sick and poorest poor? Imagine that all provider-patient panels included a significant number of homeless, poor, mentally ill, and uninsured individuals. Imagine an equal, fair, and just distribution of medical care service to the underserved that lightened that specific expectation on under-represented minority physicians (URMs). We know that URM physicians bear a disproportionate burden of providing care for the most vulnerable patients. Such a burden might substantially constrain their ability to meet quality care metrics for reimbursement.

Patient dumping is a harsh, cruel response to a healthcare and social system that can also be harsh and cruel. The goal for the U.S. healthcare system is to “ensure that every patient is a wanted patient regardless of ability to pay”.

Incidents of patient dumping such as the one recorded in Baltimore should not be cause for public consternation. The public protestation should instead be about macro-level systems and social ills that make such responses unsurprising. The above suppositions are probably wild-eyed idealist notions. But for a moment, just suppose they weren’t?

Karen Kelly-Blake photoKaren Kelly-Blake, PhD, is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Medicine 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 Thursday, August 9, 2018. 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.

More Bioethics in the News from Dr. Kelly-Blake: Incarcerated AND Sick: At Risk for Pain, Injury, and Death; White Horse, White Faces: The Decriminalization of Heroin Addiction; Racism and the Public’s Health: Whose Lives Matter?; Concussion in the NFL: A Case for Shared Decision-Making?

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