Dr. Leonard Fleck, professor in the Center for Ethics, participated in a keynote debate this month as part of the 24th annual International Bioethics Retreat that was presented virtually from Paris. Each year, “experts in medicine, philosophy, law, and health policy are invited from around the world to present their current research projects.”
Within the debate format, Dr. Fleck addressed the question: “Whole Genome Sequencing: Should It Be Publicly Funded?” Dr. Fleck defended the affirmative in this debate, while Dr. Leslie Francis of the University of Utah defended the negative. Continue reading below for Dr. Fleck’s summary of the debate.
Whole Genome Sequencing: Should It Be Publicly Funded?
Below are the key elements in the affirmative side of that debate, as well as acknowledgment of legitimate points made by Dr. Francis.
We can start with the question of what Whole Genome Sequencing [WGS] is. It refers to creating a complete map of all three billion base pairs of DNA in an individual. Next, how might WGS be used? It can be used for preventive, diagnostic, therapeutic, reproductive, and public health purposes? It can be used by adults as part of a preventive strategy, i.e., identifying genetic vulnerabilities to disorders that might be managed or prevented through behavioral change. WGS can be used diagnostically to correctly identify very rare disorders that otherwise will require a costly and painful diagnostic odyssey. This is most often true in the case of infants.
WGS is used therapeutically in the case of metastatic cancer. Both the patient and cancer tumors would be mapped in order to find a genetic driver of the cancer that could then be attacked with a targeted cancer therapy, such as trastuzumab to attack a HER2+ breast cancer. WGS can be used in a reproductive context to do non-invasive prenatal assessment of a fetus. Likewise, some advocate using WGS to do neonatal genetic screening in place of the heel stick and blood draw that will test for 56 childhood genetic disorders. WGS could test for hundreds of very rare genetic disorders that can affect children. The public health context is very visible right now as we do WGS of the COVID variants now emerging.
Why public funding? The key argument is that it is a matter of health care justice. WGS costs about $1000 for the sequencing itself, and another $2000 for the analysis, interpretation, and counseling. Insurers will generally not pay for WGS. Roughly, only the top quintile in the U.S. economic spectrum can afford to pay for WGS out of pocket. This can yield significant health advantages for them, most especially avoiding various sorts of genetic harms. More precisely, the relatively wealthy might learn of one or more health risks through WGS that would suggest the need for additional testing and therapeutic interventions, all of which would be paid for by their insurance. The less financially well off may have good health insurance but be unaware of the need to use it in a timely way without the advantage of WGS. One possible result is that a curable disease becomes incurable when symptoms are clinically evident. This is an injustice that can be avoided if access to WGS is publicly funded.
My esteemed debate partner Dr. Francis emphasized that the ethics issues are much more complex than simply matters of health care justice. The distinctive feature of any form of genetic testing is that it yields considerable information about any number of first-degree relatives who may or may not want an individual to know that information. If we do WGS on a neonate, for example, we might discover that neonate has an APOE 4/4 variant for early dementia. That means at least one parent has that vulnerability, which they might not wish to know. In addition, do those parents have any obligation to notify any other relatives of their potential vulnerability? What if, instead, it was a BRCA1 mutation for breast or ovarian cancer? More problematic still, what if WGS is used at public expense in prenatal screening with the result that some parents choose to have an abortion. Would advocates for a Right to Life view have a right to object to their tax dollars being used to facilitate access to a procedure to which they conscientiously object? This is why we have debates.
Center Assistant Professor Dr. Laura Cabrera is co-author of an article published last month in Frontiers in Human Neuroscience. Appearing in the Brain Imaging and Stimulation section of the journal, “International Legal Approaches to Neurosurgery for Psychiatric Disorders” was written by an international group of researchers.
Abstract: Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.
The full article is available online with free and open access from Frontiers.
Center Acting Director and Professor Dr. Leonard Fleck spoke earlier this month at a virtual symposium presented by University of Groningen in Groningen, Netherlands.
The event’s theme was “Barriers and future directions of personalized medicine: from the bench to the patients.” Dr. Fleck’s presentation was titled “Precision Medicine/Ethical Ambiguity: Rough Justice, Wicked Problems, fragmented Solidarity.” The symposium was funded by the European Union’s Horizon 2020 research and innovation program. As one of several keynote speakers, Dr. Fleck provided an ethicist perspective. Dr. Fleck has provided a summary of his presentation below.
Solidarity is a fundamental social value in many European countries, though its precise practical and theoretical meaning is disputed. In a health care context, solidarity means roughly equal access to effective health care for all. However, I argued that precision medicine represents a threat to solidarity. Precision medicine includes ninety targeted cancer therapies (mostly for metastatic cancer). The “targets” of these therapies are certain genetic features of a cancer, mutations responsible for “driving” that cancer’s expansion. These targeted therapies have prices of €100,000 (roughly 117,500 USD) to €150,000 (roughly 176,300 USD) annually or for a course of treatment. Our critical question: Must a commitment to solidarity mean that all these targeted cancer therapies are included in a benefit package guaranteed to all in the European Union, no matter the cost, no matter the degree of effectiveness? Such a commitment would imply that cancer was ethically special, rightfully commandeering unlimited resources. That in itself undermines solidarity. I offered multiple examples of how current and future dissemination of these drugs challenges a commitment to solidarity. An alternative is to fund more cancer prevention efforts. However, that too proves a threat to solidarity. Solidarity is too abstract a notion to address these challenges. We need instead the notion of “just solidarity.” We need to accept that we can only hope to achieve “rough justice” and “supple solidarity.” The precise practical meaning of these notions needs to be worked out through fair and inclusive processes of rational democratic deliberation, which is the real foundation of solidarity.
Center for Ethics Assistant Professor Dr. Laura Cabrera traveled to Mexico City earlier this month to give a keynote presentation at the 1st International Bioethics Congress: Knowledge, Law and New Technologies in Health.
Dr. Cabrera’s presentation, “Neuroethical Aspects of Psychiatric Neurosurgery,” gave an overview of her work as part of the NEURON Consortium with Dr. Judy Illes (University of British Columbia) on media and public perceptions around psychiatric neurosurgery. The congress had several parallel tracks touching on a variety of important bioethics topics, including neuroethics, nanomedicine, clinical ethics, research ethics, biolaw, medical devices regulation, and translational medicine.
Image description: Dr. Laura Cabrera stands while presenting her talk to attendees at the 1st International Bioethics Congress in Mexico City. Photo courtesy of Laura Cabrera.
The International Neuroethics Society (INS) Emerging Issues Task Force has a new article in AJOB Neuroscience on “Neuroethics at 15: The Current and Future Environment for Neuroethics.” Center Assistant Professor Dr. Laura Cabrera is a member of the task force, which advises INS by providing expertise, analysis, and guidance for a number of different audiences.
Abstract: Neuroethics research and scholarship intersect with dynamic academic disciplines in science, engineering, and the humanities. On the occasion of the 15th anniversary of the formation of the International Neuroethics Society, we identify current and future topics for neuroethics and discuss the many social and political challenges that emerge from the converging dynamics of neurotechnologies and artificial intelligence. We also highlight the need for a global, transdisciplinary, and integrated community of researchers to address the challenges that are precipitated by this rapid sociotechnological transformation.
The full text is available online via Taylor & Francis Online (MSU Library or other institutional access may be required to view this article).
Center Acting Director and Professor Dr. Leonard Fleck recently presented at the 2019 International Bioethics Retreat, held in Paris, France on June 26-28. Dr. Fleck chaired a session titled “In the Clinic” which featured topics on clinical ethics and medical decision-making.
In a session titled “Elder Ethics,” Dr. Fleck presented a talk on “Whither Frailty: Ethical, Economic, Medical and Policy Challenges.” Dr. Fleck addressed four key questions: (1) How should frailty be defined as a medical phenomenon? (2) What should be the scope and limits of respect for autonomy in the case of the frail elderly? (3) What should be the scope and limits of acceptable risk of harm to the frail elderly in the case of aggressive medical or surgical interventions? This question pertains to the responsibilities of physicians and surgeons in proposing such interventions. (4) What issues of health care justice deserve the attention of policymakers when it comes to meeting the health care needs of the frail elderly?
The first problem refers to the complexity of frailty as a medical phenomenon. Frailty is not disability; frailty is primarily associated with the elderly. Some researchers describe frailty as “accelerated aging.” Roughly 38% of individuals over age 90 would be described as being frail. Individuals may be frail and not have any life-threatening medical problems. Most of the frail elderly are able to make medical decisions for themselves, which is why there is the ethical issue of respect for patient autonomy versus justified medical paternalism. Among the behavioral traits of the frail elderly would be reduced activity (prolonged bed rest), very slow mobility, weight loss, extreme old age, diminished handgrip strength, polypharmacy, and social isolation. Clearly, frailty exists along a complex spectrum requiring considerable acuity of judgment to avoid ethical missteps.
To illustrate the potential for ethical missteps, labeling an elderly individual as “frail” can result in inappropriate paternalistic decisions, negative stereotypes, and discrimination. Alternatively, failure to identify an elderly individual as frail can result in overly aggressive medical treatment (and a range of avoidable medical harms) as well as a lack of attention (and resources) that might better address the social needs of the frail elderly that would represent a greater net benefit than aggressive medical treatment.
We might wish to go to the research literature for some guidance. However, there is little actual research regarding the frail elderly and aggressive medical or surgical care. Further, it is difficult to imagine how such research could be accomplished in a way that was not ethically problematic. This makes the responsibilities of physicians in clinical practice who care for the frail elderly all the more challenging.
Dr. Fleck concluded with two points: (1) From the perspective of health care justice, from the perspective of what a just and caring society ought to do, resources should be redirected from aggressive medical care for the frail elderly to their social service needs. However, the fragmented system for financing health care in the U.S. gets in the way of easily making this re-allocation of resources. (2) Soft paternalism will often be ethically justified in caring for the frail elderly considering aggressive medical care. A non-committal stance on the part of physicians in these circumstances, under the ethical guise of respect for patient autonomy, will most often be neither just, nor caring, nor respectful of patient needs and their considered values.
It is three years since the Centers for Disease Control and Prevention (CDC) reversed course to recommend that 11- to 12-year-old girls receive two doses of HPV vaccine to protect against cancers caused by human papillomavirus (HPV) infections, administered at least six months apart. This then overruled the previous “three dose” recommendation – but the CDC added the caveat that “teens and young adults who start the series later, at ages 15 through 26 years, will continue to need three doses of HPV vaccine to protect against cancer-causing HPV infection.”
When either recommending a health intervention or conducting research among adolescents (11-12 years), ethical principles require that in addition to the rightful consent processes, privacy and confidentiality especially should be observed. In that light, countries need to ensure that they meet some requirements of legal, ethical and moral issues pertaining to such situations. However, when it comes to adolescents, there commonly is some uncertainty about a proper ethical balance between protection from risks, confidentiality, privacy and the possible countervailing need for parental consent.
Image description: a black and silver stethoscope is curved around a small globe on a white background. Image source: Marco Verch/Flickr Creative Commons.
In resource-poor African settings, health access barriers are paramount, and they present major impediments to national and regional development across the continent. Additionally, before recommendations such as the aforementioned CDC HPV advice can be implemented, the pragmatic reality of the particular circumstances needs to be taken into consideration. There are other similar recommendations that are influenced by the vulnerabilities of women’s reproduction that fall into this same uncertainty.
A lack of clarity in ethical guidelines within African nations makes any attempt to follow the CDC recommendations a challenge. Moreover, there are additional dilemmas encountered when trying to follow basic ethical principles. These complexities influence the follow-up treatment for adolescents. In many cases it is the adolescent’s parents who take the primary role in decision making, oftentimes excluding those children in making decisions about their own health, and sometimes even denying them the potential benefits of health-preserving interventions. In essence, such African adolescents are left in a confused state of being both children and adults.
Using illustrative examples below, I draw from experience and insight in Tanzania. I make the case that the need for parental consent needs to be revisited so as to best customize the fit of that need to certain settings in reproductive health.
Contraceptive services
In many African countries the law is silent on the age a young person may access contraceptives. For example, according to a research conducted in Tanzania, 15 is the youngest age at which girls use contraceptives. Yet girls can obviously conceive before that age, and there is no law that prevents the usage of contraceptives at any age. Therefore, I argue that the default legal position requiring parental consent should be overruled; this would allow more freedom for young girls who wish to have access to reproductive control.
Age of consent for HIV testing
The age of consent for HIV testing is 16 years in Tanzania. Testing of persons under the age of 16 must be carried out with the consent of parents or legal guardians. However, the law does not stipulate a particular age at which an adolescent’s HIV status can be reported directly to him/her. It says only that test results are confidential and shall be shown only to the tested person with an exception of those under 18 years of age.
Age of consent for Antiretroviral Therapy (ART)
In Tanzania, the 2001 national AIDS control policy provides universal access to ART. However, there are no explicit rules regarding either age specification or consent. The policy specifies that “people living with HIV and AIDS have the right to comprehensive health care and other social services including legal protection against all forms of discrimination and human rights abuse.” Parental consent for minors therefore should not have a role in accessing ART.
Age for consent and access for Pre-exposure Prophylaxis (PreP) and Post-exposure Prophylaxis (PEP)
In the same way that HIV-infected young people should have the rights and obligations to which they are entitled, so too should they have ready access to PreP and PEP. However, since no explicit rule is in place with regard to the age of consent, might we then safely/ethically assume that any person irrespective of age should have access to PreP? Similarly, it is not clear whether an adolescent should be allowed access to, or alternatively, be prohibited from PEP as the law and guidelines are silent on access for young persons.
Abortion and post-abortion care
In Tanzania, as in all other African countries, abortion is illegal. Tanzanian law is very clear on the consequences. However, there are no age-specific-rules regarding the age of consent for access to antenatal care (ANC). Indeed, when an adolescent becomes pregnant, regardless of the young woman’s age, health workers do not require parental consent for ANC. Therefore, I maintain that this dis-equal access amounts to a contradiction in the ethics of care.
Access to HPV vaccines and cervical cancer screening and treatment
Returning to my first point, globally, Tanzania has one of the highest incidences of cervical cancer. To address this health concern, the country recently has agreed to provide HPV vaccine for girls aged 9-13 years. What then is the parental role?
This message from CDC Director Tom Frieden, MD, MPH, in a 2016 press release could perhaps be viewed as clear and feasibly be implemented in a developed country:
“Safe, effective, and long-lasting protection against HPV cancers with two visits instead of three means more Americans will be protected from cancer. This recommendation will make it simpler for parents to get their children protected in time.”
This CDC claim about simplicity presumes that such parental consent would be forthcoming and would therefore equate to full HPV protection for the adolescent. But as I’ve pointed out, that might not be the case in Tanzania and other developing countries. Perhaps we then should take a new approach in dealing with ethical issues related to accessing health in low-resource settings. Parents have an important role in ensuring the health of the adolescents, yet as I’ve demonstrated in the above, in those areas of a sensitive reproductive nature, the parental role may need to be secondary so as to ensure the adolescent’s health and well-being. If reproductive health interventions among adolescents are to succeed, perhaps we need to reach out directly to adolescents. When considering the daunting health risks adolescents face in low-resource settings, there is a need to lower access barriers and allow adolescents to consent on their own behalf. This then would give them the freedom to decide when and with whom they wish to share such sensitive information, and to directly benefit from available health interventions. This needed policy shift would place the ethics of becoming an adult in resource-challenged settings on another level.
Ms. Rose Mwangiis 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 advocating for social responsibility among global health researchers. Her recent milestone is leading the development and integration of Bioethics curriculum at Kilimanjaro Christian Medical University College (KCMUCo) as part of the European and Developing countries Partnership (EDCTP) in which UK and Tanzania are key stakeholders. Ms. Mwangi Co-Chairs the Institute Review Board (IRB) and is the Bioethics and Research Ethics instructor at KCMUCo and other medical institutions in Tanzania.
Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, July 11, 2019. With your participation, we hope to create discussions rich with insights from diverse perspectives.
You must provide your name and email address to leave a comment. Your email address will not be made public.
Center Assistant Professor Dr. Laura Cabrera was an invited expert panelist at the Organisation for Economic Co-operation and Development (OECD) workshop “Minding Neurotechnology: Delivering Responsible Innovation for Health and Well Being,” held September 6-7 in Shanghai, China.
The workshop was focused on exploring some of the unique ethical, legal, and policy challenges raised by health-related applications of brain science and its integration into cutting edge neurotechonologies. Dr. Cabrera’s session on “Identifying gaps in neurotechnology governance: potential roles of the market and the public sector to ensure ‘technology robustness’” was focused on raising potential governance issues associated with emerging neurotechnologies that deserve shared consideration given their public attention as well as their potential economic and social implications.
Image description: Dr. Cabrera (third from right) is photographed on stage with fellow panelists at the OECD event. Photo by Dr. Judy Illes.
Center Assistant Professor Dr. Laura Cabrera is one of the two International Neuroethics Society representatives who are a part of the IEEE BRAIN group. The IEEE Brain group is part of the IEEE (Institute of Electrical and Electronics Engineers), the world’s largest technical professional organization for the advancement of technology.
On August 31st, Dr. Cabrera joined the IEEE BRAIN Neuroethics subcommittee kick-off meeting at Georgetown University in Washington, D.C. This subcommittee includes philosophers, engineers, and neuroethicists, and it is tasked with putting together a document looking at ethical considerations for neurotechnologies.
Center 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.
Center for Ethics Assistant Professor 
This post is a part of our 
