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 HurtGreed Is God: The Divine Right to Avaricious Drug PricingGene 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 HurtGreed Is God: The Divine Right to Avaricious Drug PricingGene 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 DeathWhite Horse, White Faces: The Decriminalization of Heroin AddictionRacism and the Public’s Health: Whose Lives Matter?Concussion in the NFL: A Case for Shared Decision-Making?

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Drs. Eijkholt and Fleck present at International Bioethics Retreat in Paris

Marleen Eijkholt photoLeonard Fleck photoCenter Professor Len Fleck and Marleen Eijkholt, former Assistant Professor with the Center, recently presented at the 2018 International Bioethics Retreat, held in Paris, France on June 27-29. The conference has been sponsored by Cambridge University for the past eighteen years.

Dr. Fleck presented on “Personalized Medicine? Precision Medicine? What is Just Enough?” He addressed a question raised by Warwick Heale in an article in the Journal of Medical Ethics.

Heale was writing about the use of a quality-adjusted life year (QALY) cost-effectiveness methodology to make allocation decisions in health care. Heale identifies himself as a utilitarian. He generally wants to obtain the most medical good for a population group at the lowest cost. However, Heale notes that the use of this methodology is about averages for a population group. He wants to argue that if a population group cannot be treated cost-effectively with some very costly cancer drug, then it would be unjust to deny that drug to any individuals in that group whom we could identify before the fact who would benefit very significantly and cost-effectively from that drug. This has a certain intuitive moral reasonableness about it.

However, Fleck argued Heale’s proposal has some morally problematic aspects as well. He asked his audience to consider Laurel and Hardy. Both have the same medical problem; both would benefit from access to a certain costly drug. The quantity of the drug is administered on the basis of weight. It is clear that the drug is cost-effective for the average 70 kilogram person. Laurel weighs 57 kilograms. The drug is even more cost-effective for him. But Hardy weighs 90 kilograms; the drug would not be cost-effective if given to him. The logic of Heale’s position would require denying the drug to Hardy. This would strike most physicians (as well as most patients) as clearly unjust, especially if we were talking about a drug that was not absolutely scarce.

Heale wrote this paper to suggest a better approach to allocating money from the UK Conservative government’s Cancer Drug Fund, which was mostly without ethical moorings for several years. However, Fleck concluded that Heale’s proposal might effectively address the economic challenges faced by the Cancer Drug Fund while adding to the moral challenges intrinsic to the creation of the fund in the first place.

Dr. Eijkholt spoke on “Medicine’s Collusion with False Hope: False Hope Harm.” She proposed a new argument to think about interventions that are offered for consumer demands rather than for medical reasons: i.e. the False Hope Harm. She proposed that hope serves important functions in medicine. Hope can be “therapeutic” and important for patients to “self-identity as active agents.” However, in consumer medicine, like in much of the U.S. health care context, hope could also take on a different role. Scenarios like Jahi McMath and Charlie Gard make us wonder if hope can be harmful too. In fields like stem cell medicine or cancer treatment, where providers justify their support for medical interventions with “it will make them feel better,” we can also identify the risk of such harm. While one might argue that we should not deny anyone such hope in the face of emotionally vivid stories, Dr. Eijkholt argued that the profession has an obligation to avoid false hope harms.

Bioethics for Breakfast: Health Care Consolidations: Good News, Bad News, Fake News?

Bioethics for Breakfast Seminars in Medicine, Law and SocietyJohn Goddeeris, PhD, and Michael Herbert presented at the Bioethics for Breakfast event on May 10, 2018, offering perspective and insight on the topic, “Health Care Consolidations: Good News, Bad News, Fake News?” Leonard Fleck, PhD, moderated this session.

At the national level as well as in our state, the macro-level restructuring of health care delivery is impacting physician-patient clinical encounters, clinics, hospitals and health systems. As the engaged moderator for this session, Dr. Fleck guided those in attendance in examining downstream consequences of such restructuring and consolidations by posing questions to the two presenters: Dr. John Goddeeris, Professor of Economics, and Michael Herbert, Chief Executive Officer for the MSU HealthTeam.

Dr. Fleck asked the presenters to respond to the following questions: What are the basic statistics regarding health care consolidation? How does consolidation affect medical practice (and the core values of medicine)? Are patients better off as a result of consolidation? Does consolidation save the health care system money? Alternatively, does it give more pricing power to the hospital industry (against insurers who wish to demand discounts of various sorts)? Does this process have any significant effects for rural health care? Does this process increase or decrease disparities in the health care system, i.e., access to needed care for those less well off?

John Goddeeris
John Goddeeris, PhD, is a Professor of Economics in the Department of Economics in the College of Social Science at Michigan State University. Dr. Goddeeris’ expertise includes economic issues in health care, including health insurance and government programs. His research has been published widely in journals in economics, medicine, public health, and health policy. Dr. Goddeeris is a nonresident fellow in the Health Policy Center at the Urban Institute.

Michael Herbert
Michael Herbert, Chief Executive Officer for the MSU HealthTeam, is a consultant dedicated to assisting Academic Medical Centers in organizational design and operations, including hospital and faculty group practice operations, as well as Medical School operations, leadership development, strategic plan design and implementation and government policy development. He has served in a variety of high-level medical school and health system leadership positions in Michigan as well as in many other states, and was the Associate Deputy Regional Director in the Department of Veterans Affairs.

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.

Greed Is God: The Divine Right to Avaricious Drug Pricing

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

By Leonard M. Fleck, PhD

Some recent headlines worth noting: “U.S. Prescription Drug Costs Are a Crime,” “Americans Say They are Suffering as Drug Costs Continue to Rise,” “When $65,000 for a Drug is Applauded.” There were also headlines about Trump saying he was going to do something about unconscionable drug prices. This sounded like fake news, so I passed over those headlines.

At a recent health insurer conference, David Mitchell, president of Patients for Affordable Drugs, was quoted as saying, “The system is not working right, and it starts with drug companies setting the price. But everybody in the system is making more money on the higher retail price – PBMs (Pharmacy Benefit Managers), insurers, doctors administering drugs in the office … It’s exacerbated down the supply chain.” Mitchell has multiple myeloma with drug costs of $400,000 per year.

In 2001, imatinib (Gleevec®) made the cover of Time magazine. Imatinib is used to treat chronic myelogenous leukemia (CML). Over 70% of patients treated with this drug were still alive after ten years. The cost of the drug in 2001 was $36,000 per year. By 2017, the cost of the drug had risen to $146,000. Nothing changed about the drug during that interval. Production costs were the same; no additional research was necessary. Patients, however, were economic captives. Greed works.

Human life is priceless. That was the theme of a pharmaceutical video ad from a couple years ago. The implicit theme was that if your friends and family were unwilling to pay $100,000 for a drug for an extra year of life, they were obviously heartless, unethical atheists. Recall the drug sofosbuvir for hepatitis C, the $1000 per pill drug. Gilead Sciences bought the drug for $11 billion from a small research company. Sales of the drug in year one came to $10.4 billion, thereby recouping the entire cost of its “research.” It cost $10 per pill to make the drug. Gilead could charge $100 per pill, which yields a profit of 900%. However, human life is priceless, so it is more ethical to make a profit of 9900%. Greed is clever.

money pills 2 Lisa Yarost flickr
Image description: an orange pill bottle is shown on its side with capsules spilling out onto a white surface. The capsules are transparent and filled with shredded U.S. currency. Image source: Lisa Yarost/Flickr Creative Commons.

More than 90 targeted cancer therapies have FDA approval with costs per year or per course of treatment from $100,000 to $250,000 or more. They treat metastatic cancer; none of them is curative, generally yielding gains in life expectancy measurable in months, not years. For example, palbociclib (Ibrance®) is used to treat hormone-receptor positive advanced breast cancer. In treatment-naïve patients the cost per Quality-Adjusted Life-Year (QALY) gained is $768,498, while in patients who failed earlier treatments the cost per QALY is $918,166. These are cost-effectiveness figures.

In the United States, an intervention is judged cost-effective below $100,000 per QALY. The National Institute for Health Care Excellence (NICE) in the UK initially refused to include palbociclib as a covered medication in the National Health Service, but reversed that decision after price concessions. Congress, however, is prevented by law from permitting the use of cost-effectiveness as a basis for excluding a drug from Medicare coverage. This law was a product of intense lobbying by the pharmaceutical industry in 2006 using as an “ethical argument” that no patient should be denied access to a safe and effective drug merely because of price. Medicare was also forbidden by law (same lobbying effort) from either dictating the price of a drug or using its 44 million covered lives to extract huge price discounts from pharmaceutical companies in the way European countries do. Greed is politically savvy.

Pharmaceutical companies claim massive research costs. The Tufts Center for the Study of Drug Development claimed a successful cancer drug costs $2.6 billion. Dr. Jerry Avorn, faculty in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School, has critically assessed that work and concluded a more honest number is about $650 million. These debates make it appear that enormous analytical accounting work goes into justifying the price of a drug. However, the Wall Street Journal (no apologist for left-wing anti-pharmaceutical rhetoric) reported how the price of Ibrance was initially set at $9,850 per month in 2015. A bunch of executives sat around a table, looked at what insurance companies were willing to pay for comparable cancer drugs, and set the price accordingly. Before that price was made public, these executives noted that the price of everolimus (Afinitor®) had just been raised by $1,300 per month ($14,350). They were concerned they had set the price too low. Greed fell short there.

Overall, however, greed is amply rewarded. Researchers Vinay Prasad and Sham Mailankody looked at ten cancer drugs with development costs of $9 billion. Those ten drugs have generated revenue of $67 billion thus far, with years remaining on their patents. Greed pays well.

Pharmaceutical companies have purchased expensive academic talent to justify the cost of their drugs, such as Precision Health Economics (PHE), founded by Tomas Philipson, Dana Goldman, and Darius Lakdawalla, all full professors at the University of Chicago or the University of Southern California. In one article, “The Long-Term Impact of Price Controls in Medicare Part D,” associates of PHE found that proposed price controls would reduce the life expectancy of the cohort born 1991-95 by two years. In addition, “We find that price controls would reduce lifetime welfare by $5.7 to $13.3 trillion for the US population born in 1949-2005.” (Moreno G et al.) Those are scary numbers, relative to which cost-effective numbers of hundreds of thousands of dollars for various cancer drugs are economic crumbs. PHE has been intensely criticized in one ProPublica essay. Greed is seductive.

It is hard to imagine Big Pharma being inundated with warm fuzzies from the general public. However, Big Pharma has millions of zealous adherents ready to mount the legislative barricades on their behalf. 83% of patient-advocacy organizations received funding from the pharmaceutical industry and 36% have an executive from one of these firms on their board. Efforts to control drug prices are denounced as rationing or as threats to further life-saving innovation. Further, these drug companies are perceived by patients as being generous and compassionate because they provide coupons worth thousands of dollars each to patients faced with high co-pays. If a patient needs a $65,000 drug and has an unaffordable co-pay of $15,000, it is good business sense to cover that $15,000 cost to obtain $50,000 from the insurance company for a drug costing $5000 to produce. Greed is compassionate (toward the insured).

Compassionate greed has become a political, economic, and ethical reality, perfectly congruent with the Gospel of Prosperity. Health and wealth will be yours if you have unshakeable faith in the innovative grace of Big Pharma and respect their God-given right to price drugs at heavenly prices. If you prefer not to pray at the altar of Big Pharma, consider sending a copy of this essay to your member of Congress.

Fleck smallLeonard M. Fleck, PhD, is a Professor in the Center for Ethics and Humanities in the Life Sciences 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, April 5, 2018. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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