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.

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Drs. Eijkholt and Stahl present at International Conference on Clinical Ethics Consultation

Marleen Eijkholt photoDevan Stahl photoCenter faculty members Marleen Eijkholt and Devan Stahl attended and presented at the 14th International Conference on Clinical Ethics Consultation (ICCEC), held June 21-23 in Oxford, England.

Dr. Eijkholt presented as part of a collaborative panel on “Helpfulness in Clinical Ethics Consultation Notes,” which also included Dr. Stahl, Dr. Stella Reiter-Theil, and Dr. Jugen Wallner, who are respectively from Germany and Switzerland. Dr. Eijkholt presented her paper, “An Empirical View on Helpfulness in Clinical Ethics Consultation Notes,” which outlined the data that she had gathered from analyzing case consultation notes from fellow clinical ethicists. She explored the questions: What made their notes helpful? How should clinical ethics consultation (CEC) chart notes be formulated to be most helpful, while being mindful about professional boundaries, and being mindful about the recipients of these notes, i.e. vulnerable health care providers who are not necessarily philosophers? While medical providers are used to reading notes from their fellow consultants in the form of conclusions–such as, “patient is in kidney failure,” “palliative care recommends x dosages of morphine”–ethics consultants hardly ever find themselves faced with a clinical scenario that allows for such “simple” conclusions. Moreover, such authoritarian conclusions are undesirable according to the framework of the clinical ethics profession. CEC recommendations therefore take a different format. After analyzing several notes, Dr. Eijkholt concluded with an acknowledgement of the tension between quality and helpfulness.

Dr. Stahl presented on the panel “Is there a place for clinical ethics consultation outside of the hospital setting?” alongside Kevin Dirksen, Tyler Gibb, and James Hynds. The group discussed models for doing outpatient clinical ethics consultation at their respective hospital settings. Dr. Stahl presented on new efforts here in East Lansing to bridge the inpatient and outpatient settings using ethics consultation handoffs.

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Worried about your privacy? Your genome isn’t the biggest threat.

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

By Tom Tomlinson, PhD

It was good news to learn last month that the “Golden State Killer” had at last been identified and apprehended. A very evil man gets what he deserves, and his victims and their families get some justice.

The story of how he was found, however, raised concerns in some quarters. The police had a good DNA sample from the crime scenes, which with other evidence supported the conclusion that the crimes were committed by the same person. But whose DNA was that? Answering that question took some clever detective work. Police uploaded the DNA files to a public genealogy website, GEDmatch, which soon reported other users of GEDmatch who were probably related to the killer. More ordinary police work did the rest.

Most of the concern was over the fact that the police submitted the DNA under a pseudonym, in order to make investigative use of a database whose members had signed up and provided their DNA only for genealogical purposes.

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Image description: a black and white photo of the panopticon inside of Kilmainham Gaol in Dublin, Ireland. Image source: Craig Sefton/Flickr Creative Commons.

My interest in this story, however, is the way it both feeds and undermines a common narrative about our DNA—that it is uniquely identifying, and that therefore any uses of our DNA pose special threats to our privacy. As The New York Times expressed this idea, “it is beginning to dawn on consumers that even their most intimate digital data—their genetic profiles—may be passed around in ways they never intended.”

It’s true that a sample of DNA belongs uniquely to a particular individual. But the same is true of a fingerprint, a Social Security number, or an iris. More importantly, by themselves none of these pieces of information reveals who that unique individual is.

As the Golden State Killer story illustrates, it’s only when put in the context of other information that any of these admittedly unique markers becomes identifying. If the GEDmatch database contained nothing but genetic profiles, you could determine which genomes the killer was related to. But you’d have no idea who those genomes belonged to, and you’d be no closer to finding the killer.

Although an individual genome can’t by itself be identifying, it can provide a link that ties together different information sources which include that genome. It can then be that collection that points to an individual, or narrows the list of possibilities to increase the odds of identification, and the threats to privacy. Imagine the state police maintains a database of forensic DNA linked to records of criminal convictions, and provides that database to criminologists, stripped of any names or other direct identifiers. Imagine as well that one of the hospitals provides researchers with DNA from their patients along with their de-identified medical records (which can include patients’ age, race, first 3 ZIP numbers, and other demographic information).

If we put those together we can do some interesting research: use the DNA link to identify those who both committed various crimes and had a psychiatric history, so we can compare them to convicted felons without a psychiatric history.

But now it may take very little additional information to identify someone in that combined database and invade their privacy. If I’m a researcher (or hacker) who knows that my 56-year-old neighbor was convicted of assault, I can now also find out whether he has a record of psychiatric illness—and a lot more besides. What he had thought private, is no longer so.

The point of this somewhat fanciful example is that as more information is collected about us, from more sources, the threats to our privacy will increase, even if what’s contained in individual sources offers little or no chance of identification.

For this reason, the prospect of merging various data sources for “big data” health research will challenge the current research regulatory framework. Under both the current and the new rules (which haven’t yet gone into effect), the distinction between identifiable and non-identifiable research subjects is critical. Research using information that can be linked to an individual’s identity requires that person’s consent. To avoid this requirement, research data must be “de-identified”. De-identification is the regulatory backbone on which much of the current “big data” research relies, allowing the appropriation of patient medical records and specimens for use in research without consent; and it provides the regulatory basis for uploading the data collected in NIH-supported research into a large NIH-sponsored database, the database of Genotypes and Phenotypes (dbGaP), which most NIH-supported genomic studies are required to do. Data from dbGaP can then be used by other researchers to address other research questions.

The possibilities of merging such “de-identified” databases together for research purposes will only increase, including facial recognition databases being collected online and on the street. As the mergers increase, it will become more difficult to claim that the people represented in those databases remain non-identifiable. As Lynch and Meyer point out in the Hastings Center Report, at this point there will be two choices. We can require that all such research will need at least broad consent, which will have to be reaffirmed every time a person’s data is used in new contexts that make identification possible. Or we will have to fundamentally reassess whether privacy can play any role at all in our research ethics, as the very idea of “privacy” evaporates in the panopticon of everyday surveillance.

Tom Tomlinson photoTom Tomlinson, PhD, is Director and Professor in the Center for Ethics and Humanities in the Life Sciences in the College of Human Medicine, 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, July 12, 2018. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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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).

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Dr. Stahl presents at Summer Institute on Theology and Disability

Devan Stahl photoOn June 14, Center Assistant Professor Dr. Devan Stahl delivered the Jean Vanier Emerging Scholar Lecture at the Summer Institute on Theology and Disability in Raleigh, NC. Dr. Stahl was awarded this lectureship based on her dissertation work and letters of recommendation regarding her scholarship on disability. Dr. Stahl’s lecture was titled, “From Idol to Icon: Transforming Medical Images into DisArt.” Based largely on her recent book, Imaging and Imagining Illness, she discussed how fine art can transform medical images and challenge our cultural associations with disability. Dr. Stahl is the third Vanier Emerging Scholar and co-director of the PhD seminar at the Summer Institute.

To learn more about Imaging and Imagining Illness, listen to Episode 7 of the Center’s podcast, No Easy Answers in Bioethics.

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Informed Consent in Africa for Adolescents’ Participation in Health Research

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

By Rose Mwangi

I am writing to respond to a recent statement from the Co-chair of the International Vaccine Task Force (IVTF) who, in a World Bank press release, said, “We must urgently prioritize clinical research both to save lives in low-income settings, and to generate valuable information that is a global public good.”

The purpose of this article is to highlight realities of the processes that will get us to that “valuable information.”

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Image description: an individual in Kenya is photographed from the side while looking into a microscope. Image source: GSK/Flickr Creative Commons.

Researchers working with adolescents are confronted with ethical consent challenges attracting significant controversies over ethical guidelines regarding how decisions ought to be made in order for adolescents to participate in research.

Traditionally, parents have been the default decision-makers for adolescents regarding their health and/or participation in research. International guidelines also stipulate that informed consent must be given by adults, and that minors cannot provide informed consent for participation in research unless there is parental guidance or guardian permission to participate. But let’s look at the realities of the situation.

In March 2016, a study provided what they called “first-ever” national estimates of abortion incidences in Tanzania. The authors reported that 66,600 women received post-abortion care in health facilities for complications resulting from unsafe abortion in 2013 alone. Additionally, an estimated 100,000 women with complications failed to get the medical attention they needed. If we take this study as a tip of an iceberg—while we may not know whether the study was plagued by difficulty recruiting adolescent participants, or whether there are plans to further study unsafe abortion among adolescents—one may hypothesize that the majority of women under 18 in these groups did not have access to contraceptives because any intervention requiring parental consent would probably have been unfruitful, and they resulted to (unsafe) abortions against restriction by law. Thus, if we want to decrease maternal mortality among adolescents, we must ask more questions, for instance: In this study, who are these women? Could they be women of adolescent age who got pregnant, and secretly got involved in unsafe abortion because as minors they needed parental consent to use contraceptives?

Who is an adult?

The Tanzania guidelines for ethical clearance state that anyone below the age of 18 can only participate in research if a parent or guardian consents for their participation, and the concept of an emancipated minor may not be legally recognized. However, there’s clearly a conflict between the consent process in research, culture, religion, and what is legally constituted under the marriage act. In terms of religion, a Muslim girl can be married under the age of 18 years; the country’s constitution states that a boy can marry at 18 years and a girl at 15 years (Tanzania Marriage Act). The guidelines ambiguously talk about the category of emancipated minors as a legal mechanism by which the minor is freed from control by their parent. Although emancipation can be granted without due court process when a minor is bound to make a decision alone in the absence of the parents (in this case, marriage), in this conflict, does research participation call for a more stringent standard than getting married does?

Yet, in many instances in low-resource settings, poverty-driven young people below the age of 18 leave their parents in the rural areas and move to urban settings in search of greener pastures, whether to look for jobs to fend for themselves, and/or hopefully take care of their poor parents back in the rural areas. In the cities, they adopt independent lifestyles; girls may get married while the boys may take up social and economic activities, which even the parents/guardians may not know of. At present, this sort of economic independence is not recognized, and the minors cannot seek approval from the court or others to gain emancipated status.

Seeking adolescents’ consent in a low-resource setting

It is still not clear whether the assent should be verbal or signed by the adolescent, or who is the acceptable guardian where a parent is not available. This remains a silent dilemma to research ethics committees in low-resource settings. Who should consent for minors such as sex workers, hotel and bar workers, house helps, food vendors, hairdressers, etc., or young men who are involved in the transport industry and assist in loading or driving local public transport systems and other small businesses? Ironically, these are occupational activities that put the young population in these settings at risk of infectious and non-communicable diseases, an area where urgent interventions are required.

Parental informed consent among adolescents in these settings

According to the ethical guidelines, involving adolescents below the adult age of 18 would be considered a violation of the informed consent process. However, since emancipated minors are legally adults, it is high time that Tanzania and other countries in similar circumstances widened the legal recognition of adolescents other than by marriage, enabling them to participate in research on their own. Because in situations where adolescents are independent, obtaining legal consent becomes even more difficult when parents or guardians cannot be reached.

The obvious questions are: Is it realistic to look for parental consent from a parent who is solely dependent on the young adolescent for upkeep? Should these adolescents be excluded in health research? What should be the age limit for assent in such settings?

While one may argue that challenges to adolescent consent are the same across the world, there are more differences among low-income settings where cultural practices prevail, e.g., an adolescent in the U.S. is socialized in a setting where the development of society is based upon the rights of an individual, and autonomy is established when an individual reaches the age of 18. On the other hand, in an African setting, a 16-year-old may be operating at the level of a 25-year-old in terms of responsibility and decision-making, while an 18-year-old’s consent is still driven by centuries-old traditions that affirm the importance of community, society, and family. Thus, to emphasize the personal choice to participate in a clinical trial requires more interventions targeting the adolescents if we are to get valuable information that would help reduce mortality from unsafe abortions in settings restricted by law and poor resources.

Empirical evidence

With no clear empirical evidence on how many independent adolescents below the legal adult age are out there, it is difficult to make any generalizable conclusions. There is also no existing universal agreement as to what age minors can be taken as making competent decisions to participate in research among poverty-stricken hierarchical structures and cultural practices. Among the Masai, for example, the hierarchical structures and marriage practices are different from the majority of population; Masai can marry before the age of 18 years and the husband then becomes the guardian of the wife who is also below the legal adult age. Ironically, despite the legal restrictions, married adolescents across the continents who are below the age of 18 are considered emancipated minors. It would be interesting to establish whether emancipated female counterparts in U.S. and Europe would have a more independent decision over themselves in similar scenarios.

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Image description: an illustrated cartoon depicts children in a classroom. A speech bubble above the children reads, “If we don’t know which drugs are safest and most effective for pregnant women and children, why don’t they just let us into more clinical trials?” The speech bubble from the teacher reads, “To protect you from untested drugs.” Image source: Hilda Bastian/statistically-funny.blogspot.com.

Participation of adolescents in health research: The impact

While debating on realities of informed consent among adolescents in low-resource settings, a significant number may be affected by reproductive health problems, among others. It is thus important to put all efforts toward collecting data from adolescents as sole decision-makers: massive exclusion of adolescents below 18 years of age in health research would prevent researchers from identifying actual targeted or enhanced lifetime risk of diseases, or from monitoring them in the future.

In low-income settings, young and independent adolescents can contribute a lot to research findings for diseases that are prevalent among adolescents. Excluding them on the basis of being below the age of 18 is quite unethical, unrealistic and unfair while reporting 21% new HIV infections among 13- to 24-year-olds. Furthermore in developing countries, the majority of participants in research have low literacy rates, yet it is assumed that parents and guardians will understand the complex informed consent processes on behalf of the independent adolescent. As indicated by Fletcher et al. (2018), the need to be more sensitive to the social, cultural, structural, as well as medical needs of all individuals is even more urgent.

Conclusion

The way forward is to first come up with empirical evidence, and to then enact laws and processes that enable the legal emancipation of minors who are 15-17 years old, whether they are married or not, particularly in low-resource settings. I strongly agree with other authors who have stipulated that adolescents should be granted more authority and rights over themselves, while at the same time protecting them from risks as independent human subjects (Iltis, 2013; Barina & Bishop, 2013; Kuther & Posada, 2004).

Rose Mwangi photoMs. Rose Mwangi is a past beneficiary of an NIH Fogarty Fellowship at the Michigan State University Center for Ethics and Humanities in the Life Sciences. She has participated as an observer in Community Research IRBs at Michigan State University.

Ms. Mwangi is very involved in Pan-African Bioethics and does research ethics in Tanzania. She has been involved in international clinical trials playing a key role in developing consent processes for rural and low literate communities; she has done important systematic qualitative studies presented in international conferences advocating for social responsibility among global health researchers which is now a video training tool for bioethics at Kilimanjaro Christian Medical University College (KCMUCo). Ms. Mwangi Co-Chairs the Institute Review Board (IRB) and is the Bioethics and Research Ethics instructor at KCMUCo both for undergraduates and postgraduates.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, June 28, 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.

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Dr. Fleck presents at Centre for Cancer Biomarkers Symposium in Norway

Leonard Fleck photoCenter Professor Dr. Len Fleck recently traveled to Bergen, Norway to present a keynote address at the 6th Annual Centre for Cancer Biomarkers (CCBIO) Symposium. Dr. Fleck’s presentation, “Just Caring Challenges: Visible Biomarkers and Invisible Rationing,” addressed some of the critical ethical issues related to the use of biomarkers in cancer research and clinical care.

Dr. Fleck addressed two main problems in his lecture. First, the ragged edge problem. One of the primary purposes of finding biomarkers is to determine whether a cancer drug is likely to be effective for a particular metastatic cancer patient. However, rarely will a biomarker yield a simple answer. Most often, the biomarker will be expressed along a continuum. If a drug were very inexpensive and side effects tolerable, it would be easy to say that the ethically right choice would be to respect patient autonomy. But these drugs all cost more than $100,000 for a course of treatment. Consequently, if a drug has a 20% chance of having a beneficial effect, there is a conflict between considerations of justice and respect for patient autonomy. Invisible rationing (just not offering the drug to the patient) can bypass this conflict, but invisible rationing is ethically problematic so far as justice is concerned.

Secondly, recent liquid biopsies can identify eight common cancers at a very early stage–in the form of circulating cancer cells in the blood–at a cost of $500. However, the critical question would need to be raised: How often would 170 million adults (all anxious about cancer) in the U.S. have a just claim to access that test? Every six months? Every year? Note that each such offering of that test to that population would cost $85 billion. Would that represent either a just or prudent use of health care resources?

The CCBIO symposium was well-attended by an international mix of junior and senior researchers and scholars. Dr. Fleck had the opportunity to meet with many European researchers to discuss their respective work in the field of cancer research.

Dr. Fleck also gave a public lecture at the University of Bergen’s Centre for the Study of the Sciences and the Humanities, titled “Precision Medicine, Ethical Ambiguity: Rough Justice, Ragged Edges.” Dr. Fleck addressed precision medicine as it currently exists, in particular the costly FDA-approved targeted cancer therapies. Treatments for patients with metastatic cancers, which are not curative, can cost $100,000 to $475,000 per treatment course. For example, 30% of patients who are candidates for CAR T-cell immunotherapy will not gain more than an extra year of life. As things are now, we do not know before the fact who those patients might be. But one goal of biomarker research is to identify before the fact who those marginal responders most likely will be, so that we could save money by denying those patients access to this therapy. As a citizen of a just and caring society, would you endorse the research to accomplish that result? Why or why not? This is what Dr. Fleck calls “rough justice.”

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