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Christmas 2020: Finding Hope in Trying Times


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by Myles N. Sheehan, SJ, MD, Director, Pellegrino Center for Clinical Bioethics; Professor of Medicine; and Lauler Chair in Catholic Health Care Ethics

 From the December issue of The Pellegrino Report: Bioethics in Practice

Ethics can be about considering individual decisions, or it can consider who we are as persons.  The latter approach, known as virtue ethics, looks to how our decisions determine who we become.  It asks three questions: “Who am I?” What am I doing? “Who am I becoming by my actions?”

The past nine months have been an exceptionally trying time for our country and for health care clinicians.   There have been multiple crises, each of which is daunting, and, in aggregate, can be overwhelming.   For those who work at Medstar Georgetown University Hospital, the most immediate has been the Covid-19 pandemic.  But this explosion of a new infectious disease, which has strained the hospital and all who care for patients, has been in the context of new episodes of violence against people of color, of economic hardship, and of a bitterly divided country racked by conspiracy theories and distrust.

Despite all this, my experience at Georgetown, as someone newly arrived and beginning a new role as Director of the Pellegrino Center for Clinical Bioethics, I have found great hope.  Why? Because I see a group of doctors, nurses, therapists, and support staff who have answered the three key questions of virtue ethics in ways that reveal they are people who care, who show dedication and skill in caring for patients even at risk to their own health, and who are becoming an even better group for excellent and compassionate care as we, please God, move into a better future.

We can live in hope as we administer (or begin administering) the vaccination that will end the pandemic and allow us to return to something like our normal practice.  But those who have lived and worked in healthcare during this time are not going to be able to forget what they have gone through.  Walter Brueggeman, a theologian, ordained minister, and scholar of the Hebrew Scriptures, notes in a recent book that hope and faith occur in the context of lament, recognizing and mourning what has been lost. Only in a frank acknowledgment of how bad things have been can we integrate our experience, move forward, and have hope for a future that acknowledges the past and looks to something better.  Real hope is not glib and forgetful; it allows for healing and regret even while pointing to a better time.

The hope I have for the future is that we look to what we have lost and how we have been stressed but also acknowledge what has been done at MGUH.   St. Paul, in an insight that goes beyond Christianity, speaks of faith, hope, and love as three things that remain but acknowledges that the greatest of these is love.  Why? Faith without love easily turns into fanaticism and violence.  Hope without love is the precursor to the aphorism “Be careful what you hope for.”  The hope that I have comes from my witnessing the compassion of all the staff at MGUH in an extraordinarily difficult time: compassion is the expression of love for those for whom we care. 

We are not out of the woods yet, and the next few months will test our ability to continue to show compassion and to grow as persons who are seeking to do what is right and good.  Learning from these trying times and moving on to do better is at the heart of moral growth.   As the next few weeks roll out and there is ongoing challenge, please face it with hope, a hope that acknowledges the hardships but also looks to the love shown in compassion to so many patients by so many caregivers.

 

 

Good for You? Good for Me! Flattening the Curve through the Combinations of Altruism


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By Will McCreadie and James Giordano PhD

The Arabian Babbler bird is unusually generous; babblers sing and dance together, give gifts to each other, groom one another, and even compete fiercely for the privilege of helping their peers.  They feed each other’s young and vie to guard the territory while the others in their group forage.  As a species, they exemplify traits of altruism – acts of benefiting others – along a spectrum of egoism (i.e.- eliciting some relative benefit to self). Within this spectrum is competitive altruism, wherein agents act in ways that appear “selfless”, but which enable their own gain by affording some advantage within and among others. As well, there is reciprocal altruism, which entails giving in order to obtain something in return. These are not mutually exclusive; altruistic behaviors often send strong social signals that can boost the giver’s reputation.  This can lead to upward mobility within a group, and augment self-worth and well-being, as sustained by their position and supportive actions of the group, in the future.

As we have noted, every altruistic act has an egoistic component. It’s how brains work: we sense and perceive the world (and our place and status within it) through the subjective lens of self-embodiment. On some level, whether subtly or overtly, we weigh our choices and decisions for action upon the consequences that will be incurred (for ourselves) in and along temporal scale (i.e.- “Being good to others affords some good for me now and/or good for me later”, etc.). It seems that competitive giving can result in more prosocial behavior than anonymous altruism alone. Competitive altruism plays an significant role in human generosity, and allows for a deeper understanding of how people are responding to COVID-19. In turn, this may allow better incentivization(s) for altruism. Such incentives characteristically appeal to the key factors of social signaling: visibility, credibility, and social resonance.

Visibility

For generosity to be a social signal, it must be noticeable – or at least recognizable. This helps to explain why very few donations are anonymous.  A 2019 study of GoFundMe data revealed that only 21% of donations were made anonymously, and the median anonymous donation was less than the median attributed donation.  This is consistent with prior work that has shown that people tend to be far more generous when their giving is public. Clearly, visibility of some form and level plays a critical role in most peoples’ giving.

Credibility

The ethologist Amotz Zahavi was among the first to propose that an altruistic act can be a social signal, and this precept was a foundational element of what he called the handicap principle.  In this framework, making a sacrifice signals evolutionary fitness because it is a costly (and therefore hard to fake) sign that the giver is “well-off” enough to be generous. Thus, more significant acts of altruism send stronger – and better – social signals.

Social Resonance

Social norms also contribute to the valuation of particular signal. In the short- or long-term, the signal must convey something of benefit, both to the group and the giver about what is given, as well as what will be perceived as the relative value of the identity, role, and/or place of the giver within the social ecology, in order to make the signal of the altruistic act(s) worthwhile.

Altruism and COVID-19

There are two reasons to care about the spectrum of altruism as we fight the pandemic.  First, it explains acts of giving that might seem otherwise irrational. Most charitable behaviors appear to make little “egoistic” sense, because the cost of the action(s) is, by definition, to the giver, and not explicitly recouped. In other words, the proverbial “juice” does not seem to be “worth the squeeze”. But it depends on what juice, how much, and who’s savoring it.  Both reciprocal and competitive altruism expand constructs and contexts of costs and benefits to include status.  While there’s an initial cost to giving, the benefactor can increase their social status if the signal is visible, credible, and resonant.

Second, competitive giving can result in better outcomes for society as a whole. If one person donates an hour of their time to fighting the virus, someone else may contribute an hour and a half, escalating the social standard for acceptable contribution.  If these signals are visible and valuable, someone else – who perhaps wouldn’t otherwise make a contribution – may step in, feeling some socially related self-referential impetus to be at least as good as their peers. Scaling this dynamic across millions of people can radically augment our response to the virus.

Mask Wearing: Competitive Altruism Creating a New Norm

Masks are one of the most economically attractive coronavirus responses, because they offer considerable benefit for minimal cost. It’s been projected that if 95% of people wear a mask in public gatherings of any sort, 67,000 American lives could be saved by December 1st.

However, mask wearing is still far from universal. It’s been shown that men are particularly resistant to wearing face coverings, and are more likely to feel that masks are “uncool” and “signs of weakness”.

Competitive altruism could play a role in mitigating or reversing this trend. Masks are already visible and reliable signals (it’s hard to fake wearing one), but it will be important, and may be necessary to establish mask-wearing status competitiveness in order to prompt new social norms.

As we’ve noted before, it’s time for masks to be considered aspirational and ‘cool’.  Normalizing masks as an extension of personal identity and benevolent intent increases their social resonance. This sends signals that make it more “competitively desirable” for people to wear masks in public amidst the ongoing COVID crisis; establishing mask-wearers as “crusaders against COVID” and contributory to social welfare. In this way, they take on a heroically giving aspect to their social identity. And, if masks are considered fashionable, people can seek status by choosing expressive materials and creative designs. The more perceived effort someone puts into their mask habits (even if that perception is one of “I ordinarily would never wear a mask, but for the good of others, I will”), the more robustly reliable the signal, and the greater the potential for positive competition and its beneficial social effect(s).

If people can compete to protect each other (i.e.- competitive cooperative altruism), the greater the common good. Indeed, we can gain considerable insight from the past: Aristotle was right – doing good for others is rewarding for oneself. As we fight the pandemic, we should stop babbling about wearing or not wearing a mask, and embrace masks – and our actions for others – as a form of positive self-expression, with attributes for both ourselves and society.

 

Accept the Responsibilities of Participating in Public Health


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By James Giordano PhD, Professor, Departments of Neurology and Biochemistry and Senior Scholar-in-Residence, Pellegrino Center for Clinical Bioethics

The SARS-CoV-2 virus is not taking the summer off.  Recent studies by Stephanhie Pfänder and colleagues at Ruhr University Bochum (GER) have shown that the virus remains viable for almost 18 hours at temperatures of 86 degrees Fahrenheit.

While many constraints on business openings and social gatherings have relaxed, COVID hasn’t cratered, and current efforts to regain socio-economic stability, while still being topics of contention in government, are in fact precariously balanced upon peoples’ participation in doing what it takes to sustain public health.

Public health is about us, but cannot happen without us; because we are that public. It is our health, individually and collectively, that is the goal, and as such we must be – and remain – committed to the process. Continue to maintain physical distancing when out in the community, and acknowledge and accept that being in public spaces requires your active role in public health.

So, when out and about, cover your nose and mouth:

ACCEPT THE TASK .  .  . WEAR A MASK.

Photo: St. Ignatius Masked at Loyola U Medical Center Maywood Illiniois. Photo courtesy Daniel Dillinger MD

Wearing Masks and Asserting Meaning: Insights from the Neurocognitive Science of Cool


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By Will McCreadie and  James Giordano, PhD

Beginning this week, the nation as a whole will attempt relaxation of social restriction, re-engagement of public activities, and re-opening of certain businesses and venues. Four months ago, people wearing masks stood out. Now it’s those who don’t that often catch a sideways glance. Yet, despite the ongoing risk of infection amidst calls and efforts for relaxing social restrictions, some people are rebelling against wearing protective gear. Just this past weekend, when one maskless family was asked on the street about their lack of PPE, they responded, almost in unison “masks aren’t cool”. At the same time, A-list celebrities like Jennifer Lopez and Alex Rodriguez have been “corona-shamed” and labeled arrogant for not wearing masks. Why the discrepancy?

Research in neurocognitive science suggests that sentiments of “cool” are actually a complex combination of feelings of fear and aspiration. It combines the desire to be differentiated with the need to feel accepted. Studies indicate that deciding something is cool draws on two functional systems of the brain: the default mode network (DMN), and the salience network (SN). The DMN is linked to introspection and the determination of value – the rewards associated with being “cool”, while the SN plays a role in fear (often seeking to balance fears of both the behavior in question, and of being ostracized).

Such patterns of thought, emotion, and behavior are the focus of somewhat new disciplines of neuroeconomics and neuromarketing. The use of masks provides a perfect natural experiment to gauge how “cool” works, because they haven’t been common in our society since the 1918 flu pandemic, and have been now thrust into the social-spotlight.

When deciding if something is “cool,” our brains calculate the relative benefits and costs of that choice. We rarely need to ponder this judgement; we just “feel it”. The human brain takes less than 300 milliseconds to form an opinion, assessing events and consequences in our past, with the current situation, and making predictions about the near-term and future consequences of our decisions and actions. This is the phenomenon of automatic valuation.

Deciding whether something is cool, and worth the “investment” in terms of benefit, burden, and risk, comes down to figuring out what maximizes its – and your – utility. Our brains go through a rapid series of inquiry: Will this choice help me or hurt me? In the near term, or in the future? Is it the best of my available options? People aren’t perfectly rational, so we tend to base decisions and actions upon our beliefs and experience of what’s most useful.

In the case of masks, the obvious tradeoff is freedom versus safety; but considering “cool” in the equation demonstrates that other forces are also at work. What we find “cool” and feel good about depends on the image of ourselves we want to convey. We are strongly social creatures, who are sensitive to the ways we’re regarded. Whether or not you wear a mask conveys a signal (even if you don’t realize it). Social signaling plays a significant role in what we wear, and do.

This partly explains the divide in public stances on PPE. In neuroeconomic terms, masks are an identity good. People who wear masks (or dress up their Twitter profiles with mask pics) may hope to signal their virtue and intelligence, by highlighting the relative sacrifice of their comfort, both for the good of others (and for their own good – both to prevent infection, and to be perceived as socially responsible). People making unusual homemade masks may seek to highlight their resourcefulness and creativity. Those without masks are signaling something else: confidence, rebelliousness, bravery, or foolishness and selfishness — depending on your perspective.

There is also a status system in mask culture. Any recollection of middle school will surely bring to mind the in-group/out-group dynamic that plays a substantive part in determining what we find cool: with people on the “outside” aspiring to copy and outdo people on the “inside” to gain acceptance. Primate studies show this hierarchical behavior to be a side-effect of evolution. Status, and belonging to an in-group were valuable for our ancestors because the chances of survival were higher for a group member than an outcast. This primal need to conform may be a one of the factors in seeking to be “cool”. At the same time, no one wants to feel like a faceless member of the herd. To be cool, we strive for acceptance without homogeneity, and differentiation without alienation from the group.

Almost overnight COVID-19 has created a new in-group: people wearing masks. Like any major trend, there are subgroups within the mask-wearing set. The professional grade mask signals that you either are a “front-line” worker, that you have enough money to afford a scarce item, or that you’ve got good connections. People in different age groups also try to gain status by signaling different things. Teens, for example, may want branded masks (searches for designer masks increased 100-fold from mid-February to mid-April). Part of the reason why a teen covets a Supreme face mask ($450 online if you can get it), while their parents would never wear one, is that their peer groups value different things. Teens tend to want to be edgy and unique.

A significant element of cool in the age of COVID-19 is competitive – and reciprocal – altruism, which is another form of social signaling. Whether it’s the CEO of Flexport sending 3 million masks to Amsterdam, or the CEO of Twitter giving away almost a billion dollars and tracking it in a Google spreadsheet, people and companies are vying to be the most creative and effective responders to the virus. If selflessness wasn’t a valuable social signal, people would make these donations anonymously. Our research has shown that every altruistic act has an egoistic component. It’s “cool to be kind”, and as a result such acts of altruism make the actor feel good.

For many people, masks are an entirely new form of self-expression whose usefulness goes beyond their protective benefit. Simply put, as we strive to re-start our socio-economic engines for the benefit of both individuals and the population at large, masks are a currency of capability and cool. So, whether it’s making a statement of individualism, asserting acts of altruism, or evidencing a stance of responsibility, masks are a medium to represent ourselves in a commitment to each other.

Will McCreadie studies computer science and economics at Georgetown University, where he is a Baker Scholar and a Carroll Fellow.  His research in neuroeconomics examines the neurological underpinnings of decision-making.  Will’s current work explores the biological causes and economic implications of the human desire to be accepted.  He is on Twitter @McCreadieWill

James Giordano PhD is Professor in the Departments of Neurology and Biochemistry, Chief of the Neuroethics Studies Program, and Senior Scholar-in-Residence of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center.

“Philosophy and ethics in the frontiers of brain science”


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“With large scale international programs entering new phases, upcoming meetings and a growing debate, new discoveries in brain science always keep fostering ethical and social questions. Philosophy matters, in this field more than in any other, because it reminds us that science sometimes is not only obtaining new facts, but also engaging new ways of thinking about them.”

New Post from Dr. James Giordano on BioMed Central Blog.

“Recalibration” of Embryo Research Guidelines and a Private Meeting on Synthetic Human Genomes


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By SAM WU, BS and KEVIN T. FITZGERALD, SJ, PhD

Controversial breakthroughs, newly proposed guidelines, a private meeting of experts, and a lack of engagement mechanisms to include the public.  Article two in a series on emerging biotechnology.

Nature reported that two research teams have sustained human embryos in vitro for twelve to thirteen days, coming closer to the widely used 14-day limit than ever before. A potential benefit of this scientific advance is that researchers may be able to study early human development with “unprecedented precision”; on the other hand, this research once again raises ethical and practical questions of where to set limits on human embryo research. The Ethics Advisory Board of the US Department of Health, Education, and Welfare originally proposed the 14 day limit in 1979. Twelve countries have since encoded this limit into law and others have written it into guidelines, limiting almost all in vitro research to within those first 14-days of development.

Hyun, et al. suggest that the 14-day rule has been successful in our pluralistic society because it provides space for scientific inquiry and advancement, but also takes into consideration other views that stress the moral status of human embryos. In other words, the rule’s success is due to the fact that it protects the two chief goals that any rule covering human embryo research should uphold: “supporting research and accommodating diverse moral concerns.” The authors further suggest that by viewing established limits in research as “policy tools” rather than as moral truths, “it becomes clear that, as circumstances and attitudes evolve, limits can be legitimately recalibrated.”

The International Society for Stem Cell Research (ISSCR) has attempted to do just that, with the recent release of its updated guidelines on embryonic-stem cell research and clinical translation. The guidelines include several new recommendations, and promote self-regulation of the stem cell research community. One such recommendation suggests that both human embryonic stem cell research and human embryo research undergo review by Embryo Research Oversight committees.  While the ISSCR holds that the 14-day limit remain, it supports more research involving induced pluripotent stem (iPS) cells. Specifically, it recommends that generation of iPS cells be excluded from stem cell research oversight. ISSCR blames incomplete and inaccurate representations of scientific advancements, such as exaggeration of potential benefits and challenges, for public mistrust in science. It, therefore, advocates for improved communication strategies with the public.

Indeed, to “recalibrate” policies regularly in any rapidly advancing field (embryology, genomics, neuroscience, etc.) is good practice. To question current regulations is to create space and opportunity to clarify uncertainties, define goals, evaluate and improve processes, and engage more inclusively. Outcomes of these types of discussions may, in turn, inform ethical policy development that aligns more closely with societal needs and sociocultural contexts at a given time. Hyun et al. call for increased discussion and collaboration in the debate on whether to set a new limit on human embryo research, but like the ISSCR and many others in the field, they place an emphasis on the role and interests of scientists and experts. Hyun et al. propose that any rule must uphold the two chief goals of “supporting research” and “accommodating diverse moral concerns.” Do support and accommodate suggest the same level of consideration? Similarly, authors of the ISSCR guidelines have “Integrity of the Research Enterprise” as the first in a list of fundamental ethical principles intended to frame guideline development and implementation. They further state that the “primary goals of stem cell research are to advance scientific understanding and to generate evidence for addressing unmet medical and public health needs.”

 

Value Expert Knowledge over Lay Knowledge

 

 

Emphasis on the goals of the research enterprise, combined with common conceptions  of the public as anti-science or too poorly educated to make adequate decisions, encourage the use of engagement models that are more about public indoctrination than public empowerment. Both Hyun, et al., and the ISSCR guidelines, emphasize the need for researchers to communicate with and “engage the public about what they are doing and why it matters.” From their perspective, examples of good engagement practices include the International Summit on Gene Editing, which FitzGerald, Wu, and Bouchard have described as problematic, and public comment periods, which have also proved problematic in cases such as the Notice of Proposed Rulemaking (NPRM) for Revisions to the Common Rule.

Hyun et al. and many others in the scientific community advocate for what is known as the “attitudinal deficit” model – essentially a reframing of the widely criticized “information deficit” model that has been used historically in encounters between science communities and the public. A deficit model is characterized as a one-way conversation with the aim of fostering public support for science. When first introduced, the initial focus was on increasing public knowledge of scientific, technical information, but has in more recent years turned to increasing public knowledge of the potential benefits of science to society. Laudably, the ISSCR guidelines attempt to address some of the potential pitfalls of such an approach (namely ‘science hype’), calling for researchers to “promote accurate, balanced, and responsive public representations of stem cell research.” However, the ISSCR guidelines still fail to move away from the deficit model, advocating for increased transparency and information resources intended to inform rather than engage the public about stem cell research.

Use of the deficit model makes the following assumptions: that the public is at a “deficit” and needs to be informed (of technical information and/or of potential benefits to society); that a reduced deficit will increase support for science and lead to better policy-making; and, that the advancements of science are for the common good. Public engagement events designed using this unidirectional model are often without space for public deliberation or leverage to effect change. Further, by structuring engagement with the aim of fostering public acceptance of scientific research (or, as Hyun et al. put it, to “prevent a public backlash and the implementation of reactive, more restrictive limits on research),” publics are often presented with options in a take-it-or-leave it fashion. What’s more, the available options are often decided upon by experts behind closed doors (e.g. “Scientists Talk Privately About Creating a Synthetic Genome”, 2016). This leaves little room for questioning or “recalibration” of policies, processes, or institutions – exactly contrary to what Hyun, et al. and other scientists purport to want as an outcome.

Despite such criticisms, discussions and decisions regarding emerging biotechnologies continue to take place amongst experts in private. Endy and Zoloth call for “pluralistic, public, and deliberative discussions,” rightfully pointing out that closed-door discussions, such as the private meeting on synthesizing the human genome, do not allow for broader consideration of important ethical questions, potential alternatives, and unintended consequences. Our recommendations on how to operationalize the numerous calls (see also: “Human Germline Genome Editing Debate”) for improved public engagement in ongoing debates will be the subject of our next blog.

 

ABOUT THE AUTHORS

Profile for blog

 

Sam Wu, BS is a research associate at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center.

 

Kevin T. FitzGerald, MDiv, PhD, PhD Associate Professor David Lauler Chair for Catholic Health Care Ethics

 

Kevin T. FitzGerald, SJ, PhD is a research associate professor at the Pellegrino Center for Clinical Bioethics, GUMC.

 

 

 

Emerging Biotechnology in Genomics: An Advancing Field, Still Fraught with Questions


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BY KEVIN T. FITZGERALD, SJ, PhD, SAMANTHA (SAM) WU, BS, and Fr. CHARLES BOUCHARD, OP

 

In February 2016, it was reported that the Human Fertilization and Embryology Authority (HFEA) granted limited permission for researchers in the UK to genetically modify human embryos, with the hope of elucidating which genes are necessary for successful embryological development. Although Dr. Kathy Niakan and her team at the Francis Crick Institute are only allowed to use the embryos for 14 days, and may not implant a modified embryo in the womb, this permission crossed a frontier in genetic research. It was the first time human embryonic genetic modification had been authorized. This followed the publication of the controversial paper by Liang, et al. (2015) that detailed the researchers’ attempt to modify genes that cause β-thalassaemia in non-viable human embryos using the gene-editing technique, CRISPR. The paper, published in April 2015, kicked off a heated ethical debate.

Now, Frederik Lanner at the Karolinska Institute in Sweden, who got the go-ahead on a project that will also involve gene editing in human embryos, is making preparations to begin those experiments. Earlier this month, it was also reported that another team in China, led by Yong Fan, attempted to use CRISPR to generate HIV-resistant human embryos via the introduction of precise genetic modifications. While this project involved non-viable embryos, much like the research conducted by Liang, et al., “the purpose of this study was to evaluate the technology and establish principles for the introduction of precise genetic modifications in early human embryos.” The ethics committee of Guangzhou Medical University in China approved Fan’s work, and has reported that it has since approved two more similar projects.

The rapid rate of investment of both time and money in new projects involving gene editing and CRISPR makes it clear why the novel gene-editing technique was named Science’s “2015 Breakthrough of the Year.” Indeed, the technique and the research it facilitates have the potential to lead not only to treatments, but also to the elimination of some genetic mutations from the human genome altogether. Other novel biotechnologies, such as next-generation sequencing (NGS), have contributed to the revolution in gene-editing, making sequencing of the genome faster and cheaper than ever before. Clearly, these new technologies are altering, and will alter, medicine in ways that were science fiction only a few years ago.

Scientists have hailed the advancement of these projects with enthusiasm, convinced that the recent approval of the human embryo gene-editing research by funding agencies and IRBs is indicative of wider societal approval. Lanner, for instance, is hopeful that his work will be received with more optimism and less heated debate than the paper by Liang, et al. published just a year ago. At the same time, it is worth nothing that many of the ethical and practical questions, which made and continue to make the genome-editing debate controversial, remain unanswered:

Who should guide the potential impacts of these developments in clinical practice and in broader society?  What applications are ethically permissible?  Who will own these new technologies and the information resultant from their use? How should we regulate and oversee the technology in a way that such advances in science are not prioritized at the expense of public health or to the disadvantage of the poor or marginalized? 

We argue that experts in research, medicine, industry, and policy currently dominate and guide the conversation about R&D and regulation of gene-editing technology – leaving it up to the “experts” to answer the aforementioned questions of ethical and practical importance. But one might also ask, do the “experts” have the appropriate knowledge to know what is in the public’s best interest? What is the “appropriate” or relevant knowledge to make such a judgment? Are we moving forward with these projects because we have answered those questions?

CRISPR, NGS, and many other biotechnologies are all pieces of the broader discussion regarding what the future of science, medicine, and society will look like.  The outcomes of such a discussion may affect our conceptualizations of “disease” and what it means to be a “normal” human being – things that impact every human in society, not just a gathering of experts from a particular social stratum. By restricting the debate to only the “experts” or those who have a vested interest in the technology, society risks maintaining the status quo, or worse, exacerbating existing socioeconomic and health inequalities that disproportionately affect marginalized communities.

 

gene editing

 

Recent Attempts at “Public Engagement”

Many scientists and policymakers have recognized that we are at a pivotal moment in research and health care.  They acknowledge the benefits of collaboration and communication in the effort to achieve improved health.  The FDA, for instance, launched precisionFDA, an online portal that enables “scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind…[NGS].”

With CRISPR, the international research community was prompted by growing ethical concerns to host the International Summit on Human Gene Editing in Washington, DC in December 2015.  The summit brought together experts from across disciplines and continents charged with the task of discussing the “scientific, ethical, and governance issues” central to the debate on human gene-editing research. That the scientific community organized the conference suggests that it recognizes the need to incorporate a variety of perspectives in the debate. But, recognition alone is insufficient to ensure that such diverse interests are represented in the resulting policy recommendations.

At the conclusion of the summit, Chair of the Organizing Committee, David Baltimore, proposed guidelines for regulating human gene-editing research. The guidelines, however, were crafted to reflect the perspectives of scientists and academics, along with a few members of the general public who were invited and present. The guidelines lacked input from other public groups for whom human genome editing could have many implications. Unfortunately, the inadequate model of “public engagement” employed at the Summit is actually quite common across science policy issues.

Dr. Ruha Benjamin, Princeton University professor and author of People’s Science: Bodies & Rights on the Stem Cell Frontier, notes that the processes currently used to gauge public opinion on new scientific developments often create only an “illusion of opening up the science.” Institutions acknowledge, to some degree, the importance of gauging public interests and goals when it comes to scientific progress. The list of terms and mechanisms used in an attempt to determine such interests and goals is long: “public conferences,” “public meeting,” “public comment period, “public forum,” “public engagement,” and so on. Closer inspection of these mechanisms and their outcomes reveal several issues with the scientific community’s current “public engagement” efforts: 1) there is a lack of evidence and consensus to suggest which mechanism is most appropriate and when, 2) the public’s diversity of values and goals are underrepresented by a handful of public representatives, often selected by the host organization themselves, 3) differences are often resolved with more “expert” or “technical” information, rather than deeper discussion of differences in values or goals (expert knowledge is prioritized over lay knowledge), 4) the mechanism’s design provides the public with insufficient leverage to effect change in research or policy development, and 5) more often than not, there are insufficient evaluation measures in place to reinforce accountability. While these mechanisms have the potential to inform and engage the public in policy discussions that bear directly on the common good, these obstacles often lead them to fall short and leave voices unheard.

Our ethical tradition of fostering the common good says we need broader discussions that go beyond the one-way discussion that focuses on informing the public to foster “public acceptance” — beyond this “illusion of opening up the science.” We need deliberative, two-way discussions that make values and goals explicit, and that actively involve the public as community members and participants in research, clinical practice and decision-making. With genome editing, it is imperative that these discussions happen now before boundaries are crossed, even inadvertently, that cause harm to many people which cannot be readily remedied.

Moving forward, we suggest that academic institutions – increasingly home to interdisciplinary efforts and collaborations – make a much greater effort to research and design processes that engage public stakeholders in the discussion around genome editing and, more broadly, emerging biotechnologies. Several organizations have already implemented biomedical research tools and platforms created with participant preferences, values, and communities in mind that can serve as a good starting point. We also call for greater collaboration between natural science and social science researchers, which will increase our understanding of the assumptions and factors that influence policy-making and inform the design of mechanisms intended to generate a more open, deliberative public dialogue.

Sustained public engagement is essential to ensuring that science and medicine’s advancements continue to address broad public needs, and not only those of the few. Indeed, there have been calls for greater public involvement in the genome-editing debate. Despite these calls, however, the field continues to proceed with controversial experiments while ethical and practical questions remain unanswered, with scientists presuming that IRB approval of their controversial projects means that the public is becoming more accepting with “the passage of time.” It is, thus, time to increase our efforts to “open up” the science, not just to the experts, but also to those whose lives will be impacted and whose voices have yet to be heard.

 

ABOUT THE AUTHORS

Fr. Kevin FitzGerald, S.J., is research associate professor and Samantha (Sam) Wu, B.S., is a research associate at the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center; Fr. Charles Bouchard, O.P., is Senior Director, Theology and Ethics, at the Catholic Health Association of the United States.

Guiding the Tide of Neurotechnology: Coordinating the Currents of Sea-Change


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BY JAMES GIORDANO, PhD

 

Recently, the Food and Drug Administration (FDA) solicited input to guide ways that the agency regards and handles “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes”, in accordance with good practices regulation (21 CFR 10.115). The FDA will use this draft guidance to “…assist sponsors who intend to submit an IDE to the FDA to conduct clinical trials on medical devices targeting neurological disease progression and clinically meaningful patient centered outcomes”, and “… aid industry and FDA staff in considering the benefits and risks of medical devices that target … the cause or progression of neurological disorders or conditions” (such as movement disorders, like Parkinson’s disease and dystonia; as well as other pathologies, like Alzheimer’s dementia, Tourette’s syndrome, chronic pain, and psychiatric conditions such as depression).

The goal of the FDA regulation process is to establish that drugs and devices provided for medical care are safe and technically sound and the general constructs of Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) are aligned with such aims. But like any policies that tend to entail broad concepts, the real-world utility, viability and value of these programs are contingent upon: (1) the relative appropriateness to the context(s) in which any device is employed; and (2) if and how use-in practice reflects and is supported by the scope of regulatory oversight and control.

In recent years, IDE and HDE application, review and approval has become easier and more efficient; this is a notable improvement – and a step in the right direction. However, it may be that aspects of the overall structure and certain specifics of the IDE and HDE are not well suited to meet the contingencies (and exigencies) of actual clinical use of certain neurotechnologies, like deep brain stimulation (DBS).   For example, the current regulatory framework necessitates filing and securing an IDE as a first step in investigator-initiated research (IIR) and/or other off-label use of DBS in those cases where other approaches have been shown to be ineffective or untenable, and for which DBS may prove to be viable as “humanitarian care”. In such instances, it may be that the proverbial cart precedes the horse, and the HDE might be more practical and valuable given both the nature of the disorder and treatment, and the value of the HDE in establishing a basis for further (and/or expanded) application, as supportable by an IDE.

Moreover, while both IDE and HDE establish parameters for using DBS in practice, neither regulatory mechanism creates or enforces a basis for provision of economic support necessary for right and good use-in-practice. As our recent work has demonstrated, non-payment of insurance costs for pre-certified DBS interventions has been, and remains a problem of considerable concern. Absent the resources to provide: 1) DBS as a demonstrably-important or necessary treatment option for those patients with conditions that are non-responsive to, or not candidate for other therapeutic options , and 2) continuity of clinical services as required, the sustainability of this neurotechnology may become questionable (Rossi, Okun, and Giordano, 2014). This is contrary and counter-productive to recent federal incentives to maximize benefits of translating extant and new neurotechnologies into clinically-relevant and affordable care, and to implementing precision medicine . This was the focus of much discussion at the fourth National Deep Brain Stimulation ThinkTank held last month in Gainesville, FL.

In the main, actions taken by the FDA to streamline the IDE and HDE process should be applauded. Yet, while certain aspects of the IDE and HDE mechanisms may be in order and valuable for regulating use of DBS, others may require re-examination, revision, or replacement, so as to remain apace with the rising tide of developments in the field, and needs and necessities of patients and clinicians in practice. In this vein, we recommend further study of IDE and HDE mechanisms to determine what works, what doesn’t, and what can – and should – be done to both improve these practices. It is our hope that doing this will fortify regulatory, policy and legal processes to ensure that they are aligned with, directive toward, and supportive of concomitant changes in standard of care guidelines and federal insurance structure.

Important to this endeavor would be both the development of a governmental-commercial enterprise to guide industrial efforts in neurotechnology (e.g.- a National Neurotechnology Initiative; NNTI), as well as the establishment and enactment of federal laws (e.g.- a neurological information non-discrimination act; NINA) to govern potential use(s) of information obtained through DBS and related neurotechnologies that are elements of novel big data initiatives. This might be something of a sea-change, and effecting such change will demand that the constituent currents flow in the same direction. If programs such as the BRAIN initiative and agendas of precision medicine and big data are to function as a “translational estate”, and work in ways that enable technically apt and ethically sound patient care, then what is needed is coordination of the institutions, organizations, resources and activities involved. Without doubt, this will entail considerable effort, which might make waves in the status quo; but we believe that it represents a worthwhile endeavor to achieve genuine and durable progress in the development and – right and good – use of neurotechnology in clinical practice.

 

ABOUT THE AUTHOR

James Giordano, PhD Adjunct Professor Director, Neuroethics Studies    James Giordano, PhD

James Giordano, PhD is Chief of the Neuroethics Studies Program at the Pellegrino Center for Clinical Bioethics, and is Professor in the Department of Neurology at Georgetown University Medical Center. Follow more of Professor Giordano’s work at explore.georgetown.edu, and http://www.neurobioethics.org.


 

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Bioethics and Fetal Tissue Hearing


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BY G KEVIN DONOVAN, MD, MA

On March 2, 2016, Dr. G Kevin Donovan testified at the “Bioethics and Fetal Tissue” hearing before the Select Investigative Panel of the Committee on Energy and Commerce of the US House of Representatives. Dr. Donovan was one of six witnesses to present testimony.

 

Chairman Blackburn, and members of the panel, I thank you for the opportunity to present testimony regarding the bioethical considerations in the harvesting, transfer, and use of fetal tissues and organs.

I am a physician trained in both pediatrics and clinical bioethics. I have spent my entire professional career caring for infants and children. It was this interest and concern that led me to further study in bioethics, because I have always been concerned about the most vulnerable patients, those who need others to speak up for them, both at the beginning and at the end-of-life. I also have significant familiarity with research ethics, having spent 17 years as the chair of the IRB, a board that monitors the rightness and the wrongness of medical research in order to protect human subjects. We took this aspect of our duties so seriously that I renamed our IRB the Institutional Research Ethics Board. Four years ago, I was called by my mentor, Dr. Edmund Pellegrino, to take his place as director of the Center for Clinical Bioethics at Georgetown University. Our duties include ethics education for medical students and resident physicians, ethics consultation for patients and doctors at the hospital, as well as the promulgation of scholarly papers and public speaking. We focus on both clinical ethics, that which directly involves the good of patients, as well as addressing normative questions, those which involve right and wrong actions.

This is what we want young physicians to know: medicine is a moral enterprise. Our actions have consequences that can be good or bad for patients, and we must always focus on the patient’s good and avoid doing harm. So what does this mean for the topic at hand? We’re talking about bioethics and the fetus. In order to make any moral judgments, we would have to be clear on the moral status of the fetus. Obviously, this is an area in which society has not reached a consensus, but that does not mean we cannot make sound judgments on the topic. In a question of biomedical ethics, it is good to start with solid science. What do we know about the fetus with certainty? Well, first of all we know that it is alive, that it represents growing, developing, cells, tissues, and organs, all of which develop increasing complexity and biologic sophistication, resulting in an intact organism, a human baby. Of course, this growth and development does not cease with the production of the baby, but continues for many years afterwards. As can be seen by this description, the fetus is not only alive, but is demonstrably human. I’m not talking about a “potential human” in the way that some parents talk about their teenagers as potential adults. I am referring to the scientific fact that a fetus constitutes a live human, typically 46XX or 46XY, fully and genetically human. In fact, it is the irrefutable humanness of these tissues and organs that have made them be of interest to researchers and scientists.

So, if a fetus is clearly both alive and human, can we justify taking these tissues and organs for scientific experimentation? If so, under what circumstances, and what sort of consent or authorization should be required? In the past century, medicine has made incredible progress resulting from scientific studies involving human tissues and organs, resulting in the development of medications, vaccines, and the entire field of transplantation medicine. Is there any difference between these accomplishments and those that would require the harvesting of bod parts and tissues from the fetus? First, we would have to admit that not all scientific experimentation has been praiseworthy. Studies done by Dr. Mengele in Germany, and by American researchers in Guatemala and Tuskegee, we morally abhorrent, and any knowledge gleaned from these would be severely tainted. No one would want to associate our current scientific studies involving the human fetus with such egregious breaches of research ethics. All that it takes to avoid such a comparison is a consensus on the moral status of the fetus.

Those who have proceeded with experimentation and research on embryonic and fetal cells, tissues, and organs typically have obtained them as the result of an abortion. It is this stark fact that makes such scientific endeavors controversial, because they have proceeded without the aforementioned consensus on the moral status of the fetus. Because we know that the fetus is alive, and human, we must find some explanation for why it should not be treated with the same dignity that we accord all other human lives. The most frequent argument offered is that, although it is a human life, it is not a human person. Various criteria are offered for a definition of personhood, but none have been found universally acceptable. We thus have a standoff between those who would protect this early vulnerable human life and those that would deny that it deserves protection. In order to resolve such an ethical dilemma, the guiding principle is this: one is morally permitted to take such a life once you can demonstrate with moral certainty that the life is not human. It is a concept that can be exemplified by the situation faced by a hunter when he sees a bush shaking. He may sincerely believe that it is a deer in the bush, but if he kills it prior to determining with certainty what it is that he is killing, he will be morally responsible (as well as legally) if he has in fact killed the farmer’s cow, or worse yet, the farmer. As we can see, two deeply held, but opposing viewpoints need not be resolved unless someone intends to act upon them. Then, the one who intends to take the action resulting in the death of the disputed entity must not do so unless they can first show with moral certainty that their perception of its moral worth is irrefutable. Those who would not disturb the normal progression of its life bear no such burden. It’s my contention that such proof does not exist, and deliberate fetal destruction for scientific purposes should not proceed until it does.

Moreover, without disputing the arguable necessity of research on fetal tissue, I would also point out that harvesting it n such a way is unnecessary. Not only do cell lines already exist that were produced in such a fashion, but new cell lines could be obtained from fetal tissues harvested from spontaneous miscarriages. This is not a theoretical alternative. Georgetown University has a professor who has patented a method of isolating, processing, and cryopreserving fetal cells from second trimester (16-20 week gestation) miscarriages. These have already been obtained and are stored in Georgetown freezers.

Moreover, the present practices of obtaining fetal tissues and organs would seem to go against the procedures that have been approved for others who harvest tissues and organs donated for transplantation. First, we follow a strict rule, the dead donor rule. It states that vital unpaired organs cannot be obtained unless the donor has died a natural death. This obviously is not the case in an induced abortion. Moreover, such tissues or organs cannot be harvested without consent of the patient or their proper surrogate. In pediatrics, parents are considered the normal proper surrogate. However, this interpretation rests on the presumption that the parent is acting in the best interests of the individual. It is difficult to sustain such an interpretation when it is the same parent who has just consented to the abortive destruction of the individual from whom those tissues and organs would be obtained.

We are at a difficult time in our nation’s history. We demonstrate much moral ambiguity in our approach to the human fetus. We have decided that we can legally abort the same fetus that might otherwise be a candidate for fetal surgery, even using the same indications as justification for acts that are diametrically opposed. We call it the fetus if it is to be aborted and its tissues and organs transferred to a scientific lab. We call it a baby, even at the same stage of gestation, when someone plans to keep it and bring it into their home. Language has consequences, but it can also reflect our conflicts. We are a nation justly proud of the progress and achievements of our biomedical research, but lifesaving research cannot and should not require the destruction of life for it to go forward. If we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus, we cannot morally justify its destruction. Alternatives clearly exist that are less controversial, and moral arguments exist that support our natural abhorrence at the trafficking of human fetal parts. Surely we can, and surely we must, find a better way.

 


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.


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Testimony at Hearing on Maryland Physician-Assisted Suicide Bill


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BY G KEVIN DONOVAN, MD, MA

Written testimony from Dr. G Kevin Donovan at a joint hearing of the House Health & Government Operations Committee and the Judiciary Committee of Maryland on February 19, 2016, regarding the proposed end-of-life bill.

 

Thank you for the opportunity to address this proposed legislation. I am Dr. Kevin Donovan, a physician, and the director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical School. Much of my work in the hospital setting involves consultation on patients who are nearing the end of their lives, so I have a real interest in this bill.

You will hear from others about the problems that have arisen in identical bills. You will hear about the dangers it can cause to patients, particularly the disabled or chronically ill, to the medical profession, and society at large. So I will not tell you about these things. I will tell you that I oppose this bill for two reasons: it is discriminatory, not progressive, but it is deceitful.

Okay, what are we talking about? Aren’t progressive people in favor of this bill? Perhaps some are, but if they look deeply into it, they shouldn’t be. Years ago, Sen. Hubert Humphrey said the real worth of any society can be found in the way that it cares for its most vulnerable members. That would be progressive, but we live in a society that increasingly worships autonomy, freedom, and productivity, and pushes those that don’t fit the picture to the margins. Therefore, it should come as no surprise that marginalized people, the poor, blacks, Latinos, and virtually every disability rights group are afraid of this bill. It creates by law a class of people whose lives no longer should be preserved. Of course, creating separate classes of people is discriminatory, but isn’t that what the supporters of this bill want? Yes, and we should look and see who are the supporters of this bill. It is favored by the same classes of people that have taken advantage of it in places like Oregon. Who’s the typical proponent, and patient? As published statistics show, the typical patient is a white male, usually with cancer, educated and financially comfortable. This is someone who is used to thinking that they are in control, and want to maintain the illusion of control near the end their lives. And make no mistake – the data from the Oregon health department makes it clear that this is not an issue of avoiding pain. The stated reasons for seeking a fatal prescription are primarily loss of autonomy, loss of ability to engage in enjoyable activities, or fear of being a burden to others. Pain is low on the list, because with good palliative care, pain is controllable. We’ve just described legislation that would favor the white elite, not the sort of thing that progressives usually want to get behind. And as one commentator asked, “Is anyone ashamed that we live in a culture where people believe that if they aren’t autonomous, or might be a burden on others, that they should ingest drugs and die?” I would think that Maryland should be ashamed of promoting assisted suicide for patients before palliative care is universally available?

Okay, if this bill is discriminatory not progressive, why should it be seen as deceitful? First of all, our antenna should always go up when people start using euphemisms. What started out as a movement for physician assisted suicide became physician assisted death, and now just wants to be thought of as death with dignity. Really? This can’t be the only path to dignity, and it clearly is suicide that we’re talking about. After all, the Center for Disease Control defines suicide as, and I quote “Death caused by self-directed injurious behavior with an intent to die.” What we’re talking about in this bill is clearly suicide, whether or not we’re allowed to put that on the death certificate, and by the way suicide is already legal. And when we talk about the protections in this bill, we’re not being entirely forthright either. The ones who are really being protected are the physicians, once again, members of the power elite. We may say we are placing restrictions for the patients involved, but that’s not entirely true, because they’re not entirely coherent. After all, once we redefine supporting or encouraging a patient’s death as a good thing, how can we defend limiting that benefit, that good thing, to only those who will be dead in six months? Why not 12 months? Why only terminal illness – why not suffering from chronic disease? Why only assisted suicide? What if the patient can’t lift the toxic mixture to their lips – shouldn’t someone else be able to give them a lethal dose? Shouldn’t we be willing to end the suffering in this way, even if you’re under 18, even if you’re only a child? Proponents will say that this is not what the bill says, nor what they intend, but this is the natural, logical, and really inevitable result of this redefinition of death as a medical treatment. In fact, this has already happened in Belgium and the Netherlands, countries that have been doing this longer than we have.

Finally, this brings us to an area which make legislators truly sit up and take notice: it is just not good public policy. Suggesting that suicide or euthanasia, are legitimate tools of the state is frightening. Throughout history, we have learned that granting the state legal authority to kill innocent individuals has had dreadful consequences. In Maryland, if you are convicted murderer and in no way innocent, you would be protected from the killing power of the state. Why would we want to turn that power to kill on our patients with their physicians help? A Dutch cardiologist, who has experience with this in his own country, recently stated, “the fundamental question about this is whether it is a libertarian movement for human freedom and the right of choice, or an aggressive drive to exterminate the weak, the old, and the different – this question can now be answered. It is both.“ I have no doubt that some patients with great independence will choose an early death at the end of their lives. They should not be judged, they should never be prosecuted for the attempt. As a society, we should be offering patients loving support until the very end. We shouldn’t change the law in a way that might encourage their deaths, we shouldn’t take their hands and lead them towards that, and certainly shouldn’t make them feel that they are being subtly pushed into it. The sick, the vulnerable, the suffering and dying deserve so much better, and a truly caring society will provide them with no less.

 

Addendum:

” On March 4, the bill SB 418 was withdrawn by its sponsor Senator Ron Young for lack of supporting votes, killing it for the legislative year.”


 

ABOUT THE AUTHOR

G. Kevin Donovan, MD Director G. Kevin Donovan, MD, MA

G. Kevin Donovan, MD, MA is the Director of the Pellegrino Center for Clinical Bioethics at Georgetown University Medical Center. He is also a professor in the Department of Pediatrics at Georgetown University School of Medicine.


 

 

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