Center faculty presentations from ASBH 2015

asbh logoThe 17th Annual American Society for Bioethics and Humanities Meeting was held October 22-25, 2015, in Houston, TX. Center faculty Tom Tomlinson, Len Fleck, Libby Bogdan-Lovis, Karen Kelly-Blake, and Devan Stahl presented and participated in panel discussions during the conference.

tomlinsonTom Tomlinson, PhD
Director, Center for Ethics and Humanities in the Life Sciences
At ASBH I had the pleasure of making two presentations early Sunday morning. The first was “Is There a Right Not to Know?” In it I argued (with help from Devan Stahl) that despite presumptions to the contrary, patients with advanced terminal illness do not have a right to refuse information about their prognosis. Among other reasons, such a right pales by comparison to the right that is sacrificed: the right to make end of life decisions about their treatment that best preserves their values and goals. The second was “The Moral Concerns of Biobank Donors: The Effect of Non-Welfare Interests on Willingness to Donate.” In this talk I presented the results of a national survey conducted with colleagues at the University of Michigan. We argued that the survey results demonstrate that the ways in which donated, de-identified, biological specimens and data are later used matter to people’s willingness to give a “blanket consent” to any future research done with their donation. We argue that biobanks should take these concerns into account in the design of their consent process, in their public information policies, and in their review of proposed research studies.

Leonard FleckLen Fleck, PhD
Professor, Center for Ethics and Humanities in the Life Sciences
I presented Sunday morning at ASBH. The title of my presentation was “Precision Medicine/ Ethical Ambiguity?” My focus was on precision medicine as it pertained to cancer care. One often hears of cancers being identified by their “genetic signature,” or the genetic features of a cancer that drive the growth of that cancer. The goal of precision medicine is to design “targeted therapies” that match (and defeat) that genetic driver. Unfortunately, it turns out that most cancers have multiple “potential” drivers, some of which become actual drivers after a targeted cancer drug has contained the first driver. I pointed out that a major ethical problem (a matter of health care justice) is that these cancer drugs have costs of $100,000 or more for a course of treatment and generally yield on average extra weeks to extra months of life. I raised three critical questions: How many of these drugs does any one patient have a just claim to, if used in succession to defeat each emerging driver of that cancer? Keep in mind that about 600,000 individuals die of cancer each year in the US. Do all of them have a just claim to several of these targeted therapies at $100,000 each? Alternatively, a small percentage (maybe 5%) of cancer patients are “super responders” who might gain several extra years of life from having access to one or another of these, perhaps at a cost of $100,000 for each year of life gained. Should they alone have a just claim to these drugs because society is gaining so much more for the social investment? Or should access to these drugs be determined entirely on the basis of an individual’s ability to pay for these drugs (thereby sparing society the need to make explicit and painful rationing decisions)? I concluded that addressing these questions will require thoughtful and respectful democratic deliberation, not simple individual choices.

kelly-blake-crop-facbogdanlovis-crop-facKaren Kelly Blake, PhD
Assistant Professor, Center for Ethics and Humanities in the Life Sciences
In concert with research collaborators Libby Bogdan-Lovis (Assistant Director, Center for Ethics and Humanities in the Life Sciences), Nanibaa’ Garrison, (Seattle Children’s Hospital) and Faith Fletcher (University of Illinois Chicago), I presented “Identity Complexities: Unpacking Concordance in the Medical Workforce.” Our team reported preliminary results of a 2000-2015 scoping literature review to examine presumed benefits of matching URM physicians with patients sharing similar race/ethnic identities. Our project is supported by contributions of research assistants Brittany Ajegba (MSU CHM medical student), Nichole Smith (Vanderbilt premedical undergraduate), and Jessica Torres (University of Illinois Chicago MPH student). We found that of 139 abstracts meeting our inclusion criteria, medical workforce diversity is mentioned the most among variables. Patient outcomes are mentioned the least. Blacks are mentioned more frequently across primary variables. American Indian/Alaskan Native/Native American is mentioned least frequently across variables. Our next phase will be the content analysis of the 139 included articles.

stahl-crop-2015Devan Stahl, PhD
Assistant Professor, Center for Ethics and Humanities in the Life Sciences
I was on a panel with Drs. John Kilner and Jeffrey Bishop responding to Dr. Kilner’s book, Dignity and Destiny: Humanity in the Image of God, for the Bioethics and Christian Theology Affinity Group. Dr. Kilner’s book focuses on the how the image of God grants all humans inherent dignity which cannot be damaged or lost as a result of sin. The respondents then discussed the potential implications this theological anthropology has for bioethics. My response highlighted the need for a reimagining of the theological concept of dignity for persons with profound intellectual disabilities. I argued that although the concept of dignity cannot easily solve the complex issued involved in clinical ethics, it can reframe our interactions with persons with profound disabilities, whose humanity is often questioned in both theology and bioethics. By not basing our concept of dignity on any inherent capacity for intellect, righteousness, equality in relationship, etc., we allow room for those who do not have these capacities to maintain their status as bearers of God’s image and, therefore, claim them as persons worthy of respect and care. Ultimately, I argued that we ought to imagine friendship as the ultimate telos or destiny of human life. When friendship is our goal, our ethical priority is not to ‘fix” or cure what we find broken or defective in others, but to befriend persons so that they too can participate in the good life.

Dr. Fleck discusses precision medicine at Brocher Foundation event

Leonard FleckCenter Professor Dr. Leonard Fleck recently returned from Geneva, Switzerland, where he participated in a three-day event at the Brocher Foundation. Dr. Fleck was one of about 80 past Brocher Fellows who presented their current work. Dr. Fleck gave a presentation centered on precision medicine and treating cancer, titled “Precision Medicine: Can We Afford Either the Ethical or Economic Costs?”

Abstract: The language of precision medicine (targeted therapies) suggests maximal efficiency and effectiveness, especially for treating cancer. However, most cancers are extraordinarily heterogeneous in terms of their genetic drivers, which results in emerging resistance to targeted therapies. Current clinical strategy for addressing this resistance is an AIDS-like strategy, using multiple targeted therapies, either simultaneously or sequentially. The goal is to make cancer a chronic health condition extending over years. But these drugs have costs of $100,000 or more for a course of treatment. For example, ipilimumab is used to treat advanced melanoma to gain an extra life-year for $130,000. When resistance develops, pembrolizumab can be given for another life-year for $150,000. 600,000 patients die of cancer annually in the US and 1.3 million in the EU. If all 600,000 patients were provided five extra life-years at $100,000 each, that would represent $300 billion annually just for this cohort (not even other cancer patients). I will argue that no considerations of health care justice (egalitarian, utilitarian, sufficientarian, luck egalitarian) can justify such an expenditure of social health care resources, which otherwise unjustly threaten any reasonable ordering of health care priorities. If social pressure and ethical argument cannot compress the price of these targeted therapies by 80%, then an internal prioritization process among such cancer patients would be ethically necessary. I critically assess several such possibilities and suggest that none may be “just enough.”

Dr. Fleck will be presenting this work at the 17th Annual ASBH Meeting this October.

Precision Medicine/Ambiguous Ethics?

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

By Leonard Fleck, PhD

In his State of the Union Address President Obama announced that he wished to set aside $215 million for his “Precision Medicine” initiative. Given the cantankerous nature of Congress of late, this would strike many as needed political palliation. Who could be opposed to precision medicine? What member of Congress would stand up and defend “slipshod medicine” or “best guess medicine”? Fortunately, I am not running for any political office. I am not opposed to precision medicine, but there might be some ethical challenges that deserve serious consideration before the political lovefest begins.

There were two main parts to the President’s proposed initiative. One part would fund building a cohort of one million American volunteers who would agree both to have their entire genome sequenced and to provide their complete medical records to researchers. The other part would fund efforts to understand the genomes of cancer cells, the goal being to identify vulnerable features of those cells and then develop drugs that would target those vulnerable features. This yields the mantra most often invoked to describe precision medicine, namely, finding the right treatments, at the right dose, at the right time for the right person, every time. This is intended to contrast with much of contemporary medicine where many drugs have damaging and debilitating side effects, some worse than the disease they were intended to treat.

The cover story for Time Magazine (May 28, 2001) was headlined “There is New Ammunition in the War Against Cancer: These are the Bullets.” The “bullets” being referred to was the drug Gleevec (imatinib), which was used to treat chronic myeloid leukemia [CML]. The root cause of CML is a “fusion gene” known as ABL-BCR. Research had shown that if the activity of that gene could be halted the disease process could be contained as well. Imatinib was the magic bullet that did just that. Prior to imatinib, patients diagnosed with CML had about a 30% chance of surviving five years. After being treated with imatinib 60% of these patients could expect to be alive after five years. This is the beginning of “precision” medicine. No one should doubt that these were immediately recognized as astounding results.

In all the excitement no one seems to have paid much attention to the other 40% who failed to achieve five year survival. Why was imatinib not just as effective for them? The short answer was “resistance,” the ability of cancer to mutate around these drugs and begin again a deadly progression. The biological reason why cancers become resistant to these precision therapies is the genetic heterogeneity of most cancers. What this means, biologically, is that there might be one main driver for the proliferation of a tumor and numerous other potential drivers either of that tumor or of other tumors. This is what is described as either intratumor heterogeneity or inter-tumor heterogeneity.

Presently there are more than sixty cancer drugs that would be considered instances of precision medicine. That is, they are designed to target one or another of these drivers of proliferation. In general, the vast majority are only marginally effective, typically yielding extra weeks to extra months of progression-free survival at a cost of $100,000 or more for a course of treatment. The problem is that these drugs do “turn off” the main driver in some or most of the tumors that might define a cancer, thereby allowing other drivers to emerge in Darwinian fashion. This is the phenomenon known as resistance. The take home message is that most cancers are enormously more complex than researchers imagined twenty years ago.

The medical response proposed over the past three years is to follow the AIDs strategy, i.e., use multiple precision drugs, either in combination or sequentially, the goal being to make cancer for most people a managed chronic condition rather than a deadly condition. This might well be a medically appropriate goal but it is ethically problematic. About 600,000 Americans die of cancer annually; another 1.3 million are diagnosed with a cancer. If those 600,000 individuals can be given one extra year of life with the help of a $100,000 precision cancer drug, that would add $60 billion to the cost of health care in the US. If we were to use multiple drugs over five years to “manage” drug resistance, then the annual cost of these drugs for those five cumulative cohorts would be $300 billion.

Should we, as a just and caring society, be committed to achieving this goal? Is this something that we are morally obligated to do? If so, are we equally obligated to put just as much money and research effort into finding comparably effective life-prolonging interventions for all the other life-threatening medical problems individuals in our society face? Would anyone have a right to object to the additional taxes or insurance premiums that would be necessary to fight a “war on cancer” or a global war on all deadly diseases? And if we were unwilling to raise taxes or insurance premiums, then what current health care therapies would be defunded in order to underwrite precision medicine and the war on cancer?

Cancer is largely a disease of older individuals. So it seems inapt to talk about “premature deaths” in those cases. In order to control the social costs of cancer, should access to these precision drugs be limited to one course of precision therapy for those above age 75? Would that be an ethically defensible choice? This may sound ethically dangerous, but status quo options are even more ethically problematic. Individuals with very complete health insurance coverage would have very low-cost access to five years of precision medicine. But individuals with more modest (affordable) health insurance with high co-pays (30% or more for these Tier 4 drugs) would find it impossible to pay their share of the cost of these interventions, which means “ability to pay” would determine who had access to these drugs (though all Americans would have paid taxes for the basic research that made these drugs possible). Should that outcome be regarded as ethically acceptable because the implicit rationing is hidden from public view (no death panels making these choices)?

There are no easy answers to these questions. But there is no moral excuse for embracing precision medicine while ignoring the ethical ambiguity it generates.

References:

Fleck smallLeonard 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, March 5, 2015. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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