Dr. Cabrera and colleagues on cross-cultural diversity in the field of neuroethics

Laura Cabrera photoVisit The Neuroethics Blog, hosted by the Center for Ethics, Neuroethics Program at Emory University, to read “Global Neuroethics and Cultural Diversity: Some Challenges to Consider.” The piece was written by Karen Herrera-Ferrá, founder of the Mexican Association of Neuroethics, Arleen Salles, Senior Researcher at the Centre for Research Ethics and Bioethics at Uppsala University in Sweden, and Laura Cabrera, Assistant Professor at the Michigan State University Center for Ethics and Humanities in the Life Sciences.

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“Where does responsibility lie if a person acts under the influence of their brain implant?”

Laura Cabrera photoJennifer Carter-Johnson photoVisit The Conversation to read “It’s not my fault, my brain implant made me do it,” a collaborative article from Center Assistant Professor Dr. Laura Cabrera and College of Law Associate Professor Dr. Jennifer Carter-Johnson. They combine their neuroethics and legal expertise to address questions such as: “Where does responsibility lie if a person acts under the influence of their brain implant?” The article was also published in Scientific American.

In November 2017, Drs. Cabrera and Carter-Johnson participated in a Brews and Views event of the same name, “It’s not my fault: my brain implant made me do it.” Brews and Views events, moderated discussions addressing the most fascinating and provocative areas of bioscience and engineering, are a collaboration between the Institute for Quantitative Health Science and Engineering and the Center for Ethics and Humanities in the Life Sciences at Michigan State University.

Bioethics in the News from Laura Cabrera:

Bioethics in the News from Jennifer Carter-Johnson:

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Episode 8: Organ Donation Models: Eijkholt and Fleck

No Easy Answers in Bioethics logoEpisode 8 of No Easy Answers in Bioethics is now available! This episode on organ donation models features Center Assistant Professor Dr. Marleen Eijkholt and Center Professor Dr. Len Fleck. Combining their clinical ethics and health policy expertise, they sat down together to discuss ethical issues within current organ donation models, stemming from recent legislation passed in the Netherlands to implement an opt-out system of organ donation. Drs. Fleck and Eijkholt discuss positive and negative aspects of opt-out and opt-in systems, also drawing from other countries around the world. Additionally they discuss reasons why individuals may choose not to be organ donors, and the types of situations that can emerge at the bedside when grieving individuals do not want their loved one’s organs to be donated.

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 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—clinical ethics, evidence-based medicine, health policy, medical education, neuroethics, shared decision-making, and more. Episodes are hosted by H-Net: Humanities and Social Sciences Online.

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Dr. Stahl presents at Interdisciplinary Forum on Humanities in the Health Sciences

Devan Stahl photoOn Friday, March 30, Center Assistant Professor Dr. Devan Stahl participated in an Interdisciplinary Forum on Humanities in the Health Sciences, presented by the Vice President for Research and Graduate Studies at Michigan State University.

The panel consisted of five presenters discussing their latest research: Drs. Elahe Crockett (Department of Medicine), Robert Root-Bernstein (Department of Physiology), Natalie Phillips (Department of English), William Hart-Davidson (Department of Writing, Rhetoric and American Cultures), and Dr. Stahl. Each presenter discussed bridges between arts and science, how essential synthesis and translation are to medical science, and the ambiguity inherent in art, communication, and medicine. Using resources from fine art, literature, and communication, each speaker showed how medicine can benefit from engagement with the humanities and vice versa. The event was well attended by faculty from all parts of the university who were eager to discuss how to engage in interdisciplinary work.

For more on Dr. Stahl’s work at the intersection of art and medicine, listen to Episode 7 of No Easy Answers in Bioethics, the Center’s monthly podcast.

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Article from Dr. Stahl in April ‘AMA Journal of Ethics’

Devan Stahl photoCenter Assistant Professor Dr. Devan Stahl and co-author Christian J. Vercler (University of Michigan) have an article in the April 2018 issue of the AMA Journal of Ethics. Their article, “What Should Be the Surgeon’s Role in Defining “Normal” Genital Appearance?,” appears in the journal’s issue on ethical considerations in plastic and reconstructive surgery.

Abstract: The recent rise in women seeking cosmetic surgery of their genitalia (labiaplasty) coincides with the increasing number of surgeons posting videos of these operations on social media accounts and websites. Sociocultural influences significantly contribute to our ideas of what constitutes healthy and pathologic, and surgeons have historically played a role in defining “normal” and “abnormal” anatomy. In the nineteenth century, Saartjie Baartman—a woman with a large posterior and unusually long labia minora—was used by physicians to “educate” the public about these differences. We examine the parallels with the twenty-first century practice of surgeons using social media to educate patients about the operations they perform and discuss ethical and professional hazards associated with this practice.

The full article text is available online via the American Medical Association.

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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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Healthcare cost article from Dr. Fleck published in April ‘Cambridge Quarterly of Healthcare Ethics’

Leonard Fleck photoCenter Professor Dr. Leonard Fleck has a new article published in the April 2018 issue of Cambridge Quarterly of Healthcare Ethics. The article, “Controlling Healthcare Costs: Just Cost Effectiveness or “Just” Cost Effectiveness?,” appears in a special section on justice, healthcare, and wellness.

Abstract: Meeting healthcare needs is a matter of social justice. Healthcare needs are virtually limitless; however, resources, such as money, for meeting those needs, are limited. How then should we (just and caring citizens and policymakers in such a society) decide which needs must be met as a matter of justice with those limited resources? One reasonable response would be that we should use cost effectiveness as our primary criterion for making those choices. This article argues instead that cost-effectiveness considerations must be constrained by considerations of healthcare justice. The goal of this article will be to provide a preliminary account of how we might distinguish just from unjust or insufficiently just applications of cost-effectiveness analysis to some healthcare rationing problems; specifically, problems related to extraordinarily expensive targeted cancer therapies. Unconstrained compassionate appeals for resources for the medically least well-off cancer patients will be neither just nor cost effective.

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

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