Center faculty present at 20th annual American Society for Bioethics and Humanities conference

ASBH logo blueCenter faculty members Dr. Len Fleck and Dr. Devan Stahl recently presented at the 20th annual American Society for Bioethics and Humanities (ASBH) conference, held October 18-21 in Anaheim, CA.

Leonard Fleck photoDr. Fleck presented on “Parsimonious Precision Medicine: Wicked Problems.” The phrase “precision medicine” refers to targeted cancer therapies and immunotherapies that are aimed at defeating metastatic cancers with specific genetic signatures. There are more than ninety such FDA approved therapies, all of which have costs of more than $100,000 per year with some costing as much as $475,000 (CAR-T cell therapies). To date, none are curative. On the contrary, for the vast majority of patients gains in life expectancy are measurable in weeks or months, not years. These results suggest that for a just and caring society with limited resources to meet virtually unlimited health care needs, we ought to be more parsimonious in how we use these drugs and who we choose to treat.

The key point of the presentation was that whether we choose to be parsimonious in our use of targeted therapies or not, we will generate what the literature has come to describe as “wicked problems” (ethically, economically, and politically speaking). A “wicked” problem is essentially a problem for which every proposed solution (including doing nothing) generates even more problems that are equally, or more, challenging.

Devan Stahl photo

Dr. Stahl gave two panel presentations at ASBH this year. The first, “Theories of Identity and the Problem of Precedent Autonomy,” explored the ethical tensions that arise when patients in disordered states of consciousness appear to have current preferences that contradict their prior wishes. The panelists, including Dr. John Banja (Emory University) and Dr. Nancy Jecker (University of Washington), discussed the limits of philosophical analysis and theory regarding the status of precedent autonomy.

In her second presentation, Dr. Stahl was joined by Darian Goldin Stahl (Concordia University) and Dr. Jeffrey Bishop (Saint Louis University) to discuss their latest book Imaging and Imagining Illness, which explores the effect of medical imagining on patients and ways medical images can be transformed through art and philosophy.

Article from Dr. Stahl in ‘AJOB Neuroscience’

Devan Stahl photoCenter Assistant Professor Dr. Devan Stahl and co-author John Banja (Emory University) have a target article in the current issue of AJOB Neuroscience, titled “The Persisting Problem of Precedent Autonomy Among Persons in a Minimally Conscious State: The Limitations of Philosophical Analysis and Clinical Assessment.”

Abstract: Determining whether it is ethical to withdraw life-sustaining treatments (WOLST) from a patient in the minimally conscious state (MCS) recalls recurring debates in bioethics, including the applicability of precedent autonomy and the usefulness of quality-of-life assessments. This article reviews the new clinical understanding of MCS and the complexities involved in detecting covert awareness in patients. Given the diagnostic and prognostic uncertainty surrounding most MCS determinations, we review the ongoing debates concerning precedent autonomy as they apply to making WOLST determinations for patients in MCS. We also consider the moral obligations clinicians might have to understand an MCS patient’s advance directives, current preferences, and quality of life. We argue that an optimal approach for making WOLST determinations requires weighing patients’ previous wishes against their current circumstances but that even here, factual as well as ethical vagaries and disagreements will be relatively commonplace.

The full text is available online via Taylor & Francis Online (MSU Library or other institutional access may be required to view these articles).

Dr. Stahl explores how we see illness in new book ‘Imaging and Imagining Illness’

Devan Stahl photoCenter Assistant Professor Dr. Devan Stahl has a new book available from Cascade BooksImaging and Imagining Illness: Becoming Whole in a Broken Body. Edited by Dr. Stahl with a foreword from Rosemarie Garland-Thomson, the collection of essays draws from the disciplines of medical humanities, literature, visual culture, philosophy, and theology.

'Imaging and Imagining Illness' book cover
The cover of Imaging and Imagining Illness. Image courtesy of the author.

From Dr. Stahl:

Imaging and Imagining Illness explores the effects of imaging technologies on patients’ body image and self-understanding as well as the ways they influence our cultural understandings of illness. The project began as a collaboration between my sister Darian Goldin Stahl and myself. After I was diagnosed with multiple sclerosis, I shared my stories of living with MS as well as my MRIs with Darian. As a print artist, Darian began using my scans in her artwork as a way to give a more complete picture of what it is like to live with illness. Darian’s art had a profound effect on how I saw myself and inspired me to open our collaboration to others. We invited four other scholars to build on our work from their unique disciplines and shed light on the meaning of illness and the impact medical imaging can have on our cultural imagination. Drs. Therese Jones and Kirsten Ostherr offer reflections from their disciplines of medical humanities and visual culture and media studies. Having read all of the previous chapters, Drs. Ellen T. Armour and Jeff P. Bishop build on previous insights and add reflections from theology and philosophy. By engaging illness through multiple disciplines, the book represents the many ways we can understand and represent illness.

Announcing the Spring 2018 Bioethics Brownbag & Webinar Series

green brownbag and webinar iconThis year’s Bioethics Brownbag & Webinar Series resumes in February. You are invited to join us in person or watch live online from anywhere in the world. Information about the spring series is listed below. Please visit our website for more details, including the full description and speaker bio for each event.

Spring 2018 Series Flyer

Feb 15 date iconWhat’s the point of Michigan’s vaccine waiver education requirement?
Are parents changing their minds as a result of mandatory vaccine education, or are they choosing to vaccinate rather than be inconvenienced by education sessions?
Wednesday, February 14, 2018
Mark Navin, PhD, is an Associate Professor of Philosophy at Oakland University.

March 14 calendar iconPain But No Gain: Pain as a Problematic and Useless Concept?
Do references to pain help us with anything, or should we perhaps abandon pain as a “useless concept?”
Wednesday, March 14, 2018
Marleen Eijkholt, JD, PhD, is an Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Obstetrics, Gynecology and Reproductive Biology in the Michigan State University College of Human Medicine, and Clinical Ethics Consultant at Spectrum Health System.

April 11 calendar iconEthical Issues Related to Fundraising from Grateful Patients
How should the process of philanthropic development be structured in order to demonstrate respect for all persons involved?
Wednesday, April 11, 2018
Reshma Jagsi, MD, DPhil, is Professor and Deputy Chair in the Department of Radiation Oncology, and Director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan Medical School.

In person: These lectures will take place in C102 (Patenge Room) East Fee Hall on MSU’s East Lansing campus. Feel free to bring your lunch! Beverages and light snacks will be provided.

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

Can’t make it? Every lecture is recorded and posted for viewing in our archive. If you’d like to receive a reminder before each lecture, please subscribe to our mailing list.

Gene Editing: God’s Will or God’s Won’t

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

By Leonard M. Fleck, PhD

Give God a rest; do your own gene editing (and thinking). On August 2, 2017 the New York Times headline read, “In Breakthrough, Scientists Edit a Dangerous Mutation from Genes in a Human Embryo.” The mutation was of a gene called MYBPC3, and the result of that mutation is a disease called hypertrophic cardiomyopathy. This disease affects 1 in 500 people. Its victims are typically young athletes. CRISPR-cas9 is the technology used to accomplish the gene editing. More precisely, a synthetic healthy DNA sequence was injected into an egg cell fertilized by a sperm cell with the mutated gene. This healthy DNA sequence was supposed to be copied into the newly created embryo. In fact, however, the maternal DNA was copied, thereby correcting the paternal mutation in 72% of the resulting embryos. A total of 54 embryos were created, later destroyed, after genetic analysis had been done. The remaining embryos were genetically mosaic. This research received worldwide attention.

Image description: a black and white image of an 8-cell human embryo, day 3. Image source: Wikimedia Commons.

I want to raise two questions. How should we assess this research and its future possible uses from an ethical perspective? How should we assess public policies designed to regulate this research now and in the future? I am going to give more attention to this latter question in the context of a liberal, pluralistic, democratic political culture because many people would demand that the research itself be outlawed, not just regulated. The relevant question to ask is this: What sort of justification must be given for regulating or banning gene-editing technologies used to create or modify human embryos? The short answer I will defend in response to that question is that regulations must satisfy public reason and public interest requirements (as explained below).

From an ethical perspective, gene-editing technology represents considerable potential benefit, as the example of hypertrophic cardiomyopathy above suggests. At least 200 single-gene disorders could be corrected at the embryonic or pre-embryonic level, thereby preventing premature death or substantial diminishment of quality of life in these future possible children (as well as potential descendants of those children). To be clear, no gene-editing technology is ready for clinical application. Off-target effects remain a problem. From an ethical perspective, the risk-benefit ratio of such interventions today weighs too heavily on the risk side. Researchers, however, are confident that these risks can be overcome.

Assuming that the safety issues can be effectively managed, another ethical objection is that these future possible children (maybe for several generations) would not have consented to such fundamental interventions. I do not see this as a compelling objection. Parents today must consent to very risky surgery or other medical interventions in a two-year old child that could result in the death of that child or substantial lifelong impairment. We have to trust the judgment of parents and physicians in such circumstances. We have to believe they are all acting in the best interests of that child (absent compelling evidence to the contrary). This seems perfectly analogous to what would be occurring with gene-editing of an embryo. (For a broad overview of relevant ethical principles, see Wolpe et al., 2017.)

I now want to switch to concerns in the context of public policy. What sort of political justification would be needed to legitimize the complete banning of gene-editing research on human embryos? Here are two answers that are entirely “out of bounds” in a liberal, pluralistic society: (1) doing gene-editing of embryos is “playing God,” and (2) destroying embryos should never be regarded as an acceptable part of medical research.

The phrase “playing God” invokes amorphous religious associations, deliberately and arrogantly engaging in some life-or-death activity that is the exclusive prerogative of God. However, if this is supposed to be a compelling argument for public policy purposes, then large areas of medical practice would have to be outlawed as well. It might well be the will of God that I die from my heart attack, but I still want my surgeon to be agnostic and do the bypass surgery needed to save my life. God is typically described as being omnipotent, though millions of embryos are created annually with thousands of serious genetic disorders. Allowing those future possible children to suffer the awful consequences of those disorders by forbidding the development of the technology that could correct those disorders looks like willful social negligence, not impiety.

Image description: a bone cancer cell (nucleus in light blue) at the microscopic level. Image source: ZEISS Microscopy/Flickr Creative Commons.

Critics of gene-editing rail against the possible, speculative harms this technology could unleash on future generations of children, all the while ignoring the very real harms current actual children are having to suffer as a consequence of these genetic disorders. This is not just shortsighted; it is ethically and politically perverse. Virtually everyone agrees that it would be premature today to do embryonic gene-editing with the intent of bringing that future possible child to birth. However, nothing would justify laws that would forbid going forward with the research until such time as it would be safe to introduce into the clinic.

Some religious critics will object to the destruction of embryos that will be integral to the development of this technology. We noted above that 54 embryos were created and destroyed in connection with the hypertrophic cardiomyopathy research. Some religious critics will see those embryos as having the moral status of persons with the same rights as you and I. However, this is where public reason must be invoked as the appropriate basis for formulating policy in a liberal, pluralistic society.

Public reason (Rawls, 1996) must be neutral or agnostic with respect to all religious belief systems or other comprehensive worldviews. From an objective, scientific perspective embryos have no capacity to feel pain, no consciousness, no interests, and no personal identity. Embryos are not mini-persons. Some religious adherents may believe otherwise. They are free to affirm that belief in the private social space of their religious community. However, they may not seek to create laws that would effectively impose that belief on citizens who did not share that belief. This would be an illegitimate, illiberal use of the coercive powers of government unless they were able to justify such laws through an appeal to public reasons and related public interests.

Public reasons are reasons that all free and equal reasonable citizens as citizens can accept as reasonable, as consistent with the best science and fair terms of cooperation in a just society. Public reasons are the currency of rational democratic deliberation. Public interests are interests that all citizens have, and that could not be adequately protected or enhanced without the use of the coercive powers of government to control those who would threaten those interests. Protecting air and water quality would be a clear example of a public interest.

A liberal, pluralistic society recognizes and respects many reasonable ways of living a good life. Individuals are free to order their lives in accord with many different reasonable values that do not represent a threat to the rights of others or to various public interests. Consequently, such a society will accept that some people will refuse to use gene-editing technology in the future to alter the genetic endowment of their future possible children. This is political respect for procreative liberty.

It would be illiberal and illegitimate for some political group to use the coercive powers of the state to force religious individuals to use gene-editing technology, contrary to their religious beliefs. Likewise, these religious individuals must be mutually respectful of the procreative liberty rights of others to use gene-editing technology to alter the genetic endowments of their future possible children. This would include paying taxes to support the medical and scientific research needed to develop safe and effective versions of embryonic gene-editing, keeping in mind the taxes needed to pay for the health care needs of children born with cystic fibrosis or muscular dystrophy or any number of other medical problems that could have been avoided with judicious gene-editing.

In conclusion, there can be reasonable disagreement regarding various uses of embryonic gene-editing technology. However, that disagreement will have to invoke public reasons and public interests. God’s will and God’s won’t are not public interests.

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, December 14, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Humanity in the Age of Genetic Modification

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

By Jennifer Carter-Johnson, PhD, JD

Scientists have recently announced that they had used the new gene editing technique, CRISPR, to remove remnants of ancient viruses that had integrated into the pig genome. An amazing feat of genetic engineering to be sure—but the article is notable as a first step in “humanizing” pig organs for use in organ transplant by removing pig-specific viruses before they can infect human organ recipients. The idea of humanizing pigs should make us wonder—what does it mean to be human? How much genetic modification can pigs undergo and still be pigs? How do we define humanity for our neighbors and ourselves? How much genetic modification would it take to remove the label of humanity?

These questions are not asked in a vacuum nor is the research being conducted solely for philosophical inquiry. We need organs to save lives. There are over 116,000 people on the organ donor list and only 33,611 organ donations each year. About 20 people die every day in the U.S. waiting for a match so that they can receive a new heart, kidney or lung. Additionally, not everyone who actually receives a transplant has a successful outcome.

Image description: a Lego figurine of a person dressed in a pig costume is shown in the foreground against a yellow and white background. Image source: clement127/Flickr Creative Commons.

Transplant rejection occurs because each person has a fairly unique set of signal markers on their cells that allow the immune system to identify “self.” Bacterial or viral infections trigger immune responses in part because they change the infected cell’s signal markers from “self” to “foreign.” A transplanted organ also looks “foreign” to the recipient’s immune system due to the difference in signal markers, and this immune response leads to transplant rejection. For instance, identical twins would have very little risk of transplant rejection, while two unrelated people of different backgrounds would likely be unable to donate to each other. Thus, doctors search for the greatest amount of match between recipient and donor, and then suppress the recipient’s immune system to further decrease the risk of transplant rejection.

Using animal organs introduces yet more foreign signals to the organ recipient, leading to the desire to humanize those organs with markers that signal “human” and “self” to the recipient. In fact, doctors have been using pig heart valves in transplants since the 1970s. These hearts valves are extracted and then stripped of live cells to decrease the risk of rejection. This preparation procedure limits types of transplants that can be performed, and even with preparation, rejection issues may eventually arise.

Therefore, today’s scientists are working to use genetic engineering to modify pig organs to express the same cell markers that signal “self” to a human recipient. The referenced article described the development of pigs without endogenous retroviruses that some fear could infect recipients. From that basis, scientists could use several different techniques to develop pigs with humanized organs. One technique would be to genetically modify an embryo such that the pig’s cells express more “human” markers and less “pig” markers. Another technique that has been pioneered recently would be to inject human cells into a pig embryo such that the resulting chimeric pig would grow a genetically human organ.

Image description: three pigs are shown outside through metal fencing. The main pig appears to be smiling. Image source: Peppysis/Flickr Creative Commons.

Both of these techniques raise the question of what it means to be human. Merriam-Webster defines the noun human as “a bipedal primate mammal (Homo sapiens) : a person.” Furthermore, the adjective definition of the word human, “having human form or attributes,” broadens that definition in an ambiguous way that leaves us no closer to an answer than before. After all, the point of humanizing cells is to give them human attributes for organ transplantation. Surely, that isn’t enough to make the pig a human? Pigs with genomes edited to have organs that look more “human” will likely still act like pigs. But we don’t truly know how multiple genetic changes will present. Looking to the chimera technique, would a chimeric pig with the heart and kidneys of a human still be a pig? What if some of those human cells colonized the brain and some percentage of neurons were human? How do we answer the question of humanity? Do we ask what percentage of the body is human? Do we see if the animal still acts like a pig or test its skills on the SAT?

In contrast, does a person who receives a pig heart transplant cease to be human and become a pig? Humans do not have a great track record of recognizing humanity in others. Perhaps in recent times, we in the United States have not had to consider what qualifies as human. A baby born from a human mother is a human. But this concept has not always been so straightforward. Constitutional definition of a slave as 3/5 of a person and the idea of blood quantum to limit Native American rights go back to the beginning of our country. More broadly, Hitler wanted to develop a master race and viewed Jews as subhuman – leading to horrific abuses and mass murder. Today, some countries still view women as property rather than humans with rights.

Genetic technologies will challenge how we view ourselves, our neighbors, and the next generation. Genetic testing has revealed Neanderthal genetic code in many of us due to interbreeding thousands of years ago. CRISPR-based tools will eventually allow parents using artificial reproductive technologies to select genetic traits for their children. How many modifications would it take for a child to cease to be human? Perhaps super strength or gills to breathe under water sound like fantastic science fiction now, but so too did the tablets and communicators of Star Trek in the 1960s and the watch phone/TV from Dick Tracy in the 1940s. Returning to the idea of organ transplants, would a skin bag full of organs derived from a human’s cells but with no brain be considered a human? Would your answer differ if there was a brain but no higher order brain function? Such an option could reduce organ rejection to nil if a person’s cells could be used to create their own replacement organs.

The dangers of relegating a population to second tier status because they are genetically different from the norm have been explored across fiction from Animal Farm to the X-Men. Humanity’s history suggests that those stories are rooted in our inability to see humanity in those we deem as other. Advances in science mean that we need to define what it means to be human in order to avoid abuses equal to slavery or Nuremberg. Our world is changing and so too will humanity – whether or not we are prepared.

j-carter-johnsonJennifer Carter-Johnson, JD, PhD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

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

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

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Dr. Fleck published in new ‘Ethics, Medicine and Public Health’ issue

Leonard Fleck photoCenter Professor Dr. Leonard Fleck has a new article in Ethics, Medicine and Public Health. Dr. Fleck’s article, “Just caring: Do we need philosophical foundations?,” appears in the April-June 2017 issue.

The “Just Caring” problem asks: What does it mean to be a “just” and “caring” society when we have only limited resources (money) to meet virtually unlimited health care needs (linked to novel emerging medical technologies)? The practical implication of the “Just Caring” problem is that the need for health care rationing is inescapable. That means that some health care needs will not be met, even though those needs have moral weight, because meeting such needs is presumptively a matter of justice. How then can such rationing decisions be made justly or fairly? And who should have responsibility for making such decisions? Should such decision-making be the responsibility of legislative bodies, or administrators of health care institutions, or associations of physicians, or private insurers (in the United States), or employers (in the United States)? What should be the role of philosophers in addressing the problem of just health care rationing? After all, philosophers are supposed to be the experts when it comes to theories of justice. And, if philosophers are supposed to have such a role, are their judgments of health care justice going to be justified by appeal to ethical foundations of some sort? In this essay, I start by conceding that philosophers have had much to say about how we ought to conceptualize our understanding of the notion of justice. But the world has become enormously more complicated since Plato and Aristotle offered their reflections on justice. The same is true for Hume and Kant. Those perspectives seem remote and unhelpful about the problem of just health care rationing. The same would seem to be true about Rawls (1971) and Nozick (1974). Their theories of justice are simply too broad and too abstract to address the complex, heterogeneous problems of just health care rationing in the real world of health care we have today (though, as I show later, Rawls does have much to offer regarding the notion of public reason).1 In the first part of this essay I sketch out several concrete problems of health care rationing having to do with the allocation of targeted cancer therapies, drugs used to treat patients at risk for heart disease, drugs used to treat HIV+ patients, and drugs used to treat very rare diseases. This provides helpful context for the remainder of the essay. In the second part of this essay I argue that traditional theories of justice have only a limited role to play in addressing these problems of health care rationing. This is because no perfectly just answer can be given for the vast majority of real world problems of health care justice. Instead, what we need to settle for are non-ideal resolutions of these problems. Ultimately, I would defend a pluralistic conception of health care justice, which is another reason why we need to settle for non-ideal resolutions. Those non-ideal resolutions will have to emerge from broad, inclusive, fair processes of rational democratic deliberation. Those deliberations will be aimed at achieving a reflective balance of competing considerations of health care justice with respect to a very specific problem of health care rationing. In the third part of this essay, I argue that the role of philosophers is to protect the integrity of this public deliberative process, as opposed to seeking ethical foundations for their judgments of health care justice. This, I argue, entails three responsibilities for philosophers. First, these public deliberations need what we might call “just boundaries”. Those boundaries are defined by what I refer to as “constitutional principles of health care justice”. The role of philosophers is to articulate those constitutional principles and what counts as a reasonable balance among those principles as they are applied to specific problems of just health care rationing. Second, the role of philosophers is to articulate a specific understanding of “public reason”, which would govern those democratic deliberations. Here I have in mind the work of Rawls and his notions of “the rational” and “the reasonable” (Rawls, 1993). Third, philosophers have their traditional Socratic role of being thoughtful critics of the outcomes of these public deliberations, mindful of the fact that most outcomes will be non-ideally just. That is, philosophers must distinguish outcomes that are non-ideally “just enough” from those that are not “just enough”. Ultimately, the role of philosophers is not to construct or discover just foundations for these deliberative processes but to protect the fairness and integrity of the deliberative process itself.

The full text is available on the ScienceDirect website (MSU Library or other institutional access may be required to view this article).

Why not more research into preventing cancer?

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Tom Tomlinson, PhD

Why are so much money and effort put into research aimed at curing cancer, and so little devoted to preventing it?

Three professors think they have at least part of the answer, as explained in a recent New York Times article (Why Preventing Cancer Is Not the Priority in Drug Development). They report that between 1971 and 2011, there were 12,000 research trials for drugs to treat patients with later stage cancer and a 90% chance of dying in five years; but only 6,000 for earlier stage patients with a 30% chance of dying. Even more starkly, 17,000 trials enrolled patients with recurrent cancers and low chances of survival, compared to 500 studying cancer prevention, where success would potentially yield much more benefit for more people (Budish, Roin and Williams).

In other words, the most money is being spent in pursuit of the least benefit for the fewest people. Why is this?

At great risk of over-simplifying, their answer is pretty simple: the commercialization lag. This is the time span between obtaining a patent for a new drug, and getting FDA approval to market it. The 20-year patent clock starts ticking when the patent is granted, but a company doesn’t begin to make money until the FDA allows sales. The shorter the commercialization lag, the more time available to amass a profit before your blockbuster goes generic.

Image description: blue pills are spilling out of a pill bottle that is on its side. Image source: Flickr.

So how does this affect cancer drug development? If the measure of success (and FDA approval) is increased cancer survival, success can be determined most quickly in those already likely to die soon. Compared to a group of cancer patients with a 1-year life expectancy, it will take 10 times as long to detect success in a group with an average life expectancy of 10 years. This is why the commercialization lag adversely affects the profitability of research to prevent cancer or to treat it in its early stages, and so discourages such research.

Understandably, the authors of the report then discuss remedies that mitigate the effects of the commercialization lag—e.g., identifying “surrogate endpoints” that can be detected much sooner, are strongly associated with increased survival, and allow for earlier FDA approval.

I’m sure they would admit that there are other factors discouraging early-stage and preventive cancer research. Here are several that occurred to me, some of which have an ethical component.

1. Enrolling early stage patients in a trial of a new, as yet unproven cancer drug could be ethically treacherous, if there is already a standard treatment regimen supported by evidence. The cleanest design would assign some patients to the new drug and others to the standard of care, and this would be especially necessary if the surrogate end point also occurred among patients receiving conventional treatment. But this would mean that the proven treatment was being deliberately withheld from the experimental group, or delayed until the surrogate end point window closed. The interests—even the vital interests—of this group would be sacrificed for the advancement of medical knowledge. Of course, we would require that they give their informed consent to being exposed to that risk. But the quality of such consent would be highly suspect, given that it is so clearly at odds with their self-interest. These are the concerns that underlie the principle of “equipoise”—that the arms of an experiment should be roughly comparable in terms of their potential risks and benefits. (See Declaration of Helsinki, #30.)

This doesn’t mean that it is always ethically impossible to conduct research on early-stage cancer, just that it will probably be ethically more challenging to design such trials.

2. Another challenge is enrolling an adequate number of participants, especially for research on agents to prevent cancer. Studies of potential preventive drugs for cancers that occur later in life and at relatively low population rates will require large numbers to be enrolled for long periods of time to detect a statistically significant effect. If the study agent carries side effects, or burdens of compliance with the research regimen, it may discourage enrollment and encourage later drop outs.

We might address this problem by enrolling people already at high risk for cancer, which will reduce the numbers required to detect an effect. This strategy probably raises no special issues for people whose increased risk is outside their control, like women and men with one of the BRCA genetic variants carrying much higher risk of breast cancer.

But how about a study focusing on preventing lung cancer, which enrolls heavy smokers to more easily achieve scientific feasibility? Its feasibility in part depends on whether the subjects continue to smoke. And the goal of the study—to determine whether the new drug reduces the risk of smoking—may indirectly encourage participants to continue smoking. This would be due to the “therapeutic misconception,” the well-documented belief among many research participants that the experimental intervention offers a much higher likelihood of benefit than the evidence suggests (Lidz et al.).

3. And this example takes me to my last question. Would developing a whole armamentarium of drugs to prevent cancer be an unalloyed good? Of course, it’s almost certain that these drugs will carry their own side-effects and risks, as the pharmaceutical company TV ads constantly remind us; and these risks will be experienced by large numbers of people who never would have gotten cancer in any event. And for this reason, preventing cancer in this way could end up costing much more in total than treating it, as Louise Russell pointed out back at the dawn of time (Russell).

But even setting aside these complications, I would still worry about the effects that ready availability of such drugs would have on other approaches to preventing cancer, like behavior change and environmental clean-up.

If we could all just take our pills as directed, would we in the process be eroding our sense of our personal and political responsibility for the causes of cancer, and if so would that be too high a price? I’m not sure how to answer those questions. I hope you might have some ideas.

Tom Tomlinson, PhD,tomlinson is Director of the Center for Ethics and Humanities in the Life Sciences and a 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, February 4, 2016. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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

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Psychiatric Interventions: Values and Public Attitudes

Laura-CabreraLaura Cabrera, PhD, Assistant Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Translational Science & Molecular Medicine, was recently awarded funding for her project “Psychiatric Interventions: Values and Public Attitudes” by Science and Society at State (S3).

Dr. Cabrera’s team includes Robyn Bluhm, PhD, Associate Professor in the Department of Philosophy and Lyman Briggs College, and Mark Reimers, PhD, Associate Professor in the Neuroscience Program.

Learn more about “Psychiatric Interventions: Values and Public Attitudes” on S3’s 2015-2016 Funded Projects page.

S3 is an interdisciplinary research institution at Michigan State University. Learn more about their mission.

Learn more about Dr. Laura Cabrera’s research.

Vaccination, Free Riders, and Family Autonomy

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Jamie Lindemann Nelson, PhD

Still rather spent from an intense bioethics workshop in Germany the weekend just past, it was through a bit of a lingering haze that I glanced at the New York Times editorial page for the 21st of April. What attention I could muster was caught by the bottom of the page—“Vaccine Phobia in California.”

I can usually count on the Times Op-Ed writers to be on the side of the angels (as I make it out) and this time seemed no exception. Commenting on legislation pending in the California legislature that would remove exemptions from vaccination on the grounds of a parent’s “personal belief” that vaccines might harm children, the editorial briefly but effectively supported the bill. Considering it obvious that vaccines are safe and effective, the Times writers stress that near-universal vaccination is key to maintaining reliable herd immunity against a range of serious illnesses.

Herd immunity is crucial to those who cannot undergo vaccination for medical reasons, and for whom vaccines are ineffective. Yet it is imperiled particularly in California, where the rate of “philosophical” (i.e., personal belief-based) vaccine exemptions has more than tripled since 2000, and which is, not incidentally, the site of the recent Disneyland measles outbreak.

Perhaps what was left of my jet lag was to blame, but the editorial didn’t prompt the indignation at “anti-vaxxers” I have typically felt when confronting their willingness to put children at risk on such flimsy grounds. I’m inclined to think, though, that a recent lecture by a Harvard pediatrics professor, Dr. Claire McCarthy, may be the cause of my somewhat more conciliatory inclinations (McCarthy 2015).

There should be no confusion about Dr. McCarthy’s pro-vaccine views. However, she is also a thoughtful scholar. During her lecture, she spoke of a healthy child who had a routine inoculation. Very sadly, the child had an extreme reaction; shortly thereafter, he was dead.

The tragedy of a child’s death can hardly be overstated. Yet the odds of any given child dying from a vaccination are miniscule, and parents expose their kids to miniscule mortal risks every day, and sometimes pretty whimsically—think of the last time you buckled your toddler into her car seat for a quick drive through snowy streets to pick up the evening’s wine.

Still, imagine a parent reasoning like this: “I don’t live in California; my community isn’t full of people who won’t vaccinate their kids. And I know there’s no evidence for a link between vaccination and autism. What I’m scared about is Dr. McCarthy’s story. In my town, I can count on robust herd immunity. Why, then, should I expose my own precious child to even a very small risk of death when I don’t need to? She’ll be fine so long as we keep an eye on the vaccination rates wherever we live or visit.”

There’s an obvious reply: this plan is plainly unjust. It allows her family and her child to benefit at the expense of other kids who have undergone the same very small risk this parent rejects, in order to secure the herd immunity on which she relies. Her “justification” seems a textbook example of “free riding.”

Yet families are a curious kind of social institution. Small-scale, and typically intimate associations in which much important work of personal identity formation and maintenance goes on, they make up a centerpiece of the most important part of many people’s lives. To perform their special functions well, they are widely recognized as requiring some degree of insulation from some of the moral norms that people are expected to follow in their dealings with strangers and acquaintances.

Justice is often seen as one of those norms whose full force gets a bit diluted in families. For example, families are routinely allowed to pass along from generation to generation resources, training, and traditions that may well entrench social inequalities; many conceptions of justice see those inequalities as indefensible. In a fairer world, we mightn’t be suffered to favor “our own” to such an extent. Yet many would reply “so much the worse for fairness.”

Utilitarians may sigh and deontologists scold, but people typically don’t think that the moral claims of strangers are as significant as are those of family; that just seems part of what it is to love some people and not others. The “free riding” charge may be simply another departure from general moral norms allowed by what many theorists have called “family autonomy.”

Of course, if you can’t get a philosophical exemption, there’s always the option of homeschooling. Yet I’m coming to think this response is rather draconian, at least absent a more pressing public health emergency. Not all parents can responsibly educate their children through high school, and what the children of such parents might miss could impair them in ways far more serious than a typical case of the measles.

There seems a less confrontational option—gentle persuasion based on clearly presented facts. The Times Op Ed concedes this very point, noting that the rate of unvaccinated kids in California schools declined during this school year, due to a “new requirement that parents speak to a licensed health care professional about vaccines and the risks of not getting vaccinated.” (New York Times, April 21, 2015, p. A 22.)

Yet not all observers have the Times’ confidence in education. Last April, Pediatrics published a study entitled, “Effective Messages in Vaccine Promotion” (Nyhan, et al. 2014). Almost 1800 parents were randomized to either a control group, or to one of four types of pro-vaccine messages: information debunking the vaccine-autism link; messages about the dangers of measles, mumps and rubella; images of children who have those diseases; a dramatic story about a child who almost died of measles.

The study’s take-home lesson? None of the messages increased parents’ inclination to vaccinate. Some of them actually made matters worse. Nor does the study address our imagined parent who fears, not autism, but the tiny chance of vaccination-induced death.

If education won’t work, is there anything short of coercion available? A study by Douglas Opel and colleagues (Opel, et al. 2013) found that presumptive, rather than participatory language and behavior on the part of health care professionals increased compliance. The trick is to treat vaccination as the standard expectation, and if parents demur, to respond along the lines of, “Look, Mary really needs these shots.” If parents object strenuously, they’ll not be overridden, but that is a very different matter from encouraging engagement in decision-making.

While there’s a good deal to argue about here, I think that presumptive approach to vaccination may be on balance defensible—it can help secure herd immunity against damages caused by dissenters, whether they mean to free ride, or simply don’t believe that shots do anyone any good, thus saving some children and parents a good deal of anguish. It doesn’t ride roughshod over the deep convictions of people implacably opposed to vaccination. It simply treats as a routine matter what should be seen as a routine matter, in a way analogous to letting science teachers determine that evolution structures the curriculum.

Admittedly, the presumptive approach hardly seems strictly in keeping with the gospel of informed consent and respect for autonomy, whether of individuals or of families. But strict fundamentalism doesn’t seem to me to be a more attractive policy in bioethics than in religion.

  • McCarthy, C.  2015. A Sticky Decision. Lecture, Harvard University Medical School, March 19.
  • New York Times. 2015. Vaccine Phobia in California.  April 21, p. A 22.
  • Nyhan, B., et al. 2014. “Effective Messages in Vaccine Promotion.” Pediatrics (doi: 10.1542/peds.2013-2365)
  • Opel, D., et al. 2013. “The Architecture of Provider-Parent Vaccine Discussions at Health Supervision Visits.” Pediatrics (doi: 10.1542/peds.2013-2037)

jamie-nelsonJamie Lindemann Nelson, PhDis a Professor of Philosophy in the College of Arts and Letters at Michigan State University.

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