World Bioethics Day: Human Dignity and Human Rights

Posted by Leah Lowthorp on October 19th, 2016

Untitled Document The first World Bioethics Day, sponsored by the UNESCO Chair in Bioethics, is taking place on October 19. This year’s theme of Human Dignity and Human Rights will be celebrated in 55 countries worldwide (see here for a list of participating countries and here for a list of planned events).

While most countries are hosting one or two World Bioethics Day events, India has planned a whopping 29. The only event scheduled in the United States is at Indiana University Northwest, which will include presentations on bioethics and human rights and a screening of “No Más Bebés,” a documentary about Mexican-American women who were coercively sterilized at Los Angeles County-USC Medical Center in the 1960s and 1970s. (Filmmakers Virginia Espino and Renee Tajima-Peña joined CGS on the UC Berkeley campus in 2016 to screen the film as a part of the Being Human in a Biotech Age series. They were also interviewed for the CGS online series Talking Biopolitics by eugenics scholar and CGS advisory board member Alexandra Minna Stern, see here and on YouTube.)

Human dignity and human rights, in addition to being the theme of this first annual World Bioethics Day celebration, form the primary framework of most of the international and national legislation worldwide that prohibits inheritable genetic modification, also known as human germline modification. The most notable among these is the Council of Europe’s 1997 Convention on Biomedicine and Human Rights (see here for a global list of national legislation banning inheritable genetic modification).

It is surprising that human genetics has such a low profile among the list of World Bioethics Day events. 2015 and 2016 have seen unprecedented technological developments with troubling implications for human germline modification – such as the public policy controversies surrounding reproductive applications of gene editing and human experimentation with mitochondrial manipulation techniques (or “three-person IVF) in Mexico and the Ukraine.

Out of 88 events today, only one sponsored by the Bosnia and Herzegovina Unit features genomics as its main theme. Five others, two in Italy and one each in Slovenia, Macedonia, and India, will include individual presentations on the wider topic of human genetics. The Bosnia and Herzegovina event is Bioethics in the Era of Genomics and Personalized Medicine, an international conference that will take place in Sarajevo on October 28.

Previously on Biopolitical Times:

Image via UNESCO

7 Highlights from Nuffield Council’s Review on the Ethics of Genome Editing

Posted by Jessica Cussins, Biopolitical Times guest contributor on October 18th, 2016

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The UK Nuffield Council on Bioethics’ recently released report, Genome Editing: an ethical review  (full version available here) is the most substantial and thorough assessment of its kind. It delves deeply into the ethical, social, and political underpinnings and implications of genome editing, and touches on related, converging technologies including synthetic biology, gene drives, and de-extinction. A second report with ethical guidance regarding the use of genome editing for human reproduction is due in early 2017 from a Council working group chaired by Karen Yeung

This first report will be an important reference for people across disciplines for some time, and I will not do justice to its scope and breadth here. However, I want to draw attention to just seven concepts that are particularly helpful and illuminating, as much for their framing of the questions at stake as for their content. I briefly summarize each point, and select key quotes from the report.

1. On emerging technology and innovation

Contrary to frequent assumptions, innovation in science and technology is neither linear, autonomous, nor pre-destined. It is continuously co-produced in relation to a complex intersection of actors, institutions, market-drivers, and serendipity. Momentum and sunk costs can however encourage adherence to certain technological pathways, meaning the choice of paths we take should not be undertaken blindly, or lightly.

“A commonplace but now largely discredited perspective viewed science as a resource from which innovators draw, leading to new technological innovations that provide social or commercial benefits, such as increased wellbeing and productivity. The flaws in this ‘linear model’ are generally thought to stem from its failure to give due attention to the complexity of innovation processes, the importance of feedbacks, the role of markets and other actors, and the effects of uncertainty and serendipity. Science now tends to be seen less the wellspring of technological innovation than a ‘co-producer’ along with these other forces and actors.” (15)

“The factors that act to attract, secure and consolidate investment may also have the effect of confirming a course for innovation, creating both ‘lock in’ of contingent technological forms and forward momentum along a particular technological pathway. The reasons for this include factors such as sunk costs, learning effects, increasing returns to scale, high transaction costs associated with any change of direction and the mutual adaptation between technologies and associated conditions of use, including the structure, governance and practice of institutions, and not excluding social conditions, normative rules and standards, and public acceptance.” (18)

2. On the “editing” metaphor

Discussion of “genome editing” as opposed to “genetic modification” or “genetic engineering” has a re-framing effect that serves to distinguish the newer technological capabilities as more “precise,” as well as to diminish their consequences by avoiding connotation with such loaded terms as “GMO.” The “editing” metaphor instead conjures images of easily altered language or computer code.

“Whether intentionally or not, the ‘editing’ metaphor distinguishes the approach from less ‘precise’ forms of genetic ‘engineering’ and, simultaneously, distances it from their associated connotations, including the range of public responses that these terms typically excite. The editing metaphor also plays on characterisations of the genome as the ‘book of life’ containing ‘sentences’ (genes) made up of a ‘genetic alphabet’ of four ‘letters’ (A, C, G and T, the initial letters of the four chemical bases comprising DNA) that were common around the time of the Human Genome Project. The editing metaphor transfers easily to the more contemporary image of modifying computer code. The metaphor suggests not only the type but also the significance of the intervention: it is technical, is not dependent on scale (as it applies equally to changes large or small) and is seen as corrective or improving (at least in relation to the editor’s vision).

“In this way, the concept of editing has a certain thickness, whereby, while apparently descriptive, it implies a tacit evaluative judgement. It also implies an editor (the one who does the editing) and, by deeper implication, may distinguish the editor, who merely corrects and improves, from a putative, creative ‘author’. But whether authorship is assigned to a divinity or not, the implication is that the work of editing is trivial in comparison.” (19-20)

3. On the public interest

Science and technology are intimately connected with the public interest. They are forged through public funding and support, and they act upon and within the world, with impacts on the well-being and welfare of the public. 

“There is a public interest in research for at least two main reasons. The first is to the extent that a great deal of research in the academic sector is publicly funded, from money collected through general taxation. This implies a public interest in the fact that this money is spent in a way that reflects public priorities and pursues them with the greatest possible efficiency. The second, more profound, reason is that products and practices, processes and tools produced by the application of knowledge gained through research may have a direct or indirect impact on the wellbeing and welfare of the public (including their moral and social welfare). The public have an interest in science, in terms of its expectation of net social benefits, and invests in science both financially and through the trust placed in scientists to contribute to the delivery of these benefits. But more profoundly than this, the public have an underlying public interest in the overall moral and ethical texture of the society in which they live. How technologies like genome editing are taken up and regulated both reflects and influences the broader moral values on which common social life is based and the social meaning of the practices in question.” (21)

And, quoting from Sheila Jasanoff’s article “Technology as a site and object of politics”:

“…technology, once seen as the preserve of dispassionate engineers committed to the unambiguous betterment of life, now has become a feverishly contested space in which human societies are waging bitter political battles over competing visions of the good and the authority to define it. In the process, the virtually automatic coupling of technology with progress, a legacy of the Enlightenment, has come undone. Uncertainty prevails, both about who governs technology and for whose benefit. No matter which way one looks, the frontiers of technology are seen to be at one and the same time, frontiers of politics.” (21)

4. On normality, moral norms and rights

Should we judge what constitutes an acceptable or unacceptable biological intervention using a concept of what is “normal?” What would that mean and who would decide? What lessons must we heed from 20th century eugenics programs about desires to direct humanity?

“While nature contains many prodigies, the normal can serve to orientate moral action (for example, in terms of whether that action tends to support what is regarded as normal functioning or produce divergence from it). What counts as normal is therefore a legitimate question but often one that is highly contested with regard to the extent to which norms are related to natural states or socially constructed, particularly in relation to issues of disability, medical intervention and enhancement. Disability justice and rights scholars have made a range of moral arguments against selective technologies, from individual rights based arguments such as the right to life of people with disabilities, to arguments for the social and emotional value (e.g. vulnerability to contingency) of biological difference, to the value to humankind of conserving disability cultures, and the importance of the visibility of disability in establishing social attitudes, behaviour, and structures.” (28)

“A particular concern that has been raised is that genome editing combined with social liberalism may facilitate the ‘consumerisation’ of human biology, and the spread of ‘consumer’ or ‘liberal’ eugenics, driven by the choices of parents rather than by state policy, but with possibly similar, socially divisive results. Objections here concern the practice as well as the consequences: that the biological conditions of human existence should not be the subject of choice since they allegedly interfere with identity of the person in morally significant ways.” (52)

5. On social justice and a just society

The advantages and opportunities of science and technology in general, and of genome editing in particular, may not be fairly distributed among different groups, different nations, or across generations. Developments cannot therefore be seen outside of the context of social, intergenerational and global justice. 

“Such concerns require us to attend to the need to ensure that measures (such as the introduction of a new biotechnology) that affect welfare do so without discriminating unfairly among people. Although people may be equal in dignity and the enjoyment of rights, they are not equally situated with regard to the benefits and harms of biomedicine and biotechnology. Certain people may be disproportionately affected, may find themselves (perhaps involuntarily) in circumstances that render them particularly vulnerable, or be excluded from access to decision making or to benefits that are available to others. As a result, they may experience unfair discrimination and systematic disadvantage. It is argued by many that dignity and rights discourse is, in fact, insufficient to ground socially just action and that a specifically social justice perspective is called for: they consider it to be essential to put in place means for tracking social justice outcomes over time, and social justice goals in regulation of genome editing technologies.” (29-30)

6. On public policy

Public policy initiatives around genome editing are high-stakes, representing a collective vision of a desirable future, and determining those actions deemed unacceptable to the public interest. Public policy is both reflective of and impactful upon the society in which it functions, and in the world at large.

“As well as forestalling or redressing unjust treatment of individuals, public policy measures both reflect and affect the kind of society in which they are implemented, including the relationship between public and private, how and to what extent different groups and members participate in social life, how different priorities, preferences and values are resolved or tolerated, how equal or unequal in power, status and wealth its members are, and how open or closed the society may be. The features of any society are complex, interdependent and dynamic, but public policy measures often imply and express consistent common values and may be articulated around a collective vision of the desirable future state that they are expected to contribute to bringing about. These, in turn, influence the behaviours, institutions and culture of the society, for example whether it is welcoming or hostile to difference in terms of ethnicity, belief, appearance or ability.” (30)

7. On looking forward

Genome editing is a new development that has garnered enormous excitement. It is important to discuss the impacts of this disruptive new technology, but it will also be useful to avoid inevitability arguments, sky-high expectations, and to remember that it is just one element of a number of larger converging technologies. Future discussions would benefit from beginning with real human challenges or problems, rather than with a technology for its own sake.

“It should be remembered that most prospective technologies fail, and that some lead to undesirable consequences, a fact often obscured by ‘whig’ histories that reconstruct the history of successful technologies and their beneficial social consequences. Scientific discovery and technological innovation is important but not inevitable. Most important among the factors shaping technological development is human agency. It is human agency, in terms of decisions that are made about directions of research, funding and investment, the setting of legal limits and regulatory principles, the design of institutions and programmes, and the desire for or acceptance of different possible states of affairs, that will determine whether, and which, prospective technologies emerge and, ultimately, their historical significance.” (112)

“We are convinced that it makes little sense to treat the questions raised by genome editing as if they belonged to a single field (a hypothetical discipline of ‘genome editing studies’). Rather, they should be addressed as part of different technology convergences (e.g. with ART, with gene drives, with agricultural technologies, etc.), which also includes political technologies (regulation, legislation, etc.). But, more than that, we conclude that it is not the scale at which questions are posed but also their orientation that is important. Beginning with questions about what can be achieved at the genome level risks reducing all questions to ‘ELSI’ questions (questions about the ethical, legal and social implications of genome editing, as if that were the only or most obvious pathway available to address a complex set of real world challenges) and leaving questions about the appropriateness of genome technologies in any given case unaddressed. This is why the next, normative, phase of our work should begin with problems or challenges (and the potential diverse framings of those challenges), rather than technologies, and adopt a comparative methodology.” (115)

Previously on Biopolitical Times:

Image via Nuffield Council on Bioethics

3-Person IVF Breaking News: Where Are the Advocates for the Public Interest?

Posted by Leah Lowthorp on October 7th, 2016

Turquoise microscopic image of human egg being injected with sperm with long needle in vitro
The unapproved technique involves injecting sperm into an engineered two-person egg via intracytoplasmic sperm injection or ICSI (pictured).

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The first baby born as a result of the “3-person IVF” technique known as maternal spindle transfer (MST) was reported by New Scientist on September 27. To avoid US regulation, a team led by Dr. John Zhang of New Hope Fertility Center performed the unapproved and controversial procedure in Mexico. Now five months old, the child appears healthy but may encounter serious problems later in life.

Media coverage of this event in the United States and United Kingdom has been overwhelmingly celebratory, downplaying the serious health risks involved for the child and future generations, as well as Zhang’s flagrant disregard of established US regulatory policies (see New Scientist, New York Times, BBC, and The Telegraph). Zhang’s widely cited self-justification – “To save lives is the ethical thing to do” – has not been examined, despite the clear conclusion in the recent Institute of Medicine report that this technique “does not address a medical need,” let alone save lives, as it “would not treat an existing person for a disease, illness, or condition.”

Outside the US and UK, media coverage has been more tempered. While less celebratory, the German press has been surprisingly uncritical, despite emphasizing the fact that the procedure is illegal in Germany. The Portuguese language press has tended to syndicate translations of the English language press, although the Observador published a thoughtful piece raising questions about potential “Lego-babies.” The French language press has tended more towards the critical side, often including a section devoted to the health and/or ethical risks associated with the procedure. An article by Grégory Rozičres at Le Huffington Post (France) warned, “This can be seen as the first step on a dangerous path…The risk of eugenic abuses is evident.” 

A number of news stories did include comments from public interest advocates, scientists, and policy experts voicing a range of concerns. Nature News quoted biologist David Clancy saying, “They just went ahead and did it. The number of issues that are still unresolved — it’s just staggering.” In the same article, University of Miami (Florida) legal scholar Rosario Isasi “question[ed] the wisdom of performing the procedure in Mexico.” Isasi commented, “You have all these negatives, and it’s not a place that can offer the scientists a high-tech environment.”  For other examples, see coverage at NPR, NBC News, Forbes, and BBC.

Several statements and articles explored the concerns in more depth. The Center for Genetics and Society released a press statement emphasizing the unsafe nature of the procedure, its unknown health consequences for the child and future generations, and the dangerous precedent set by renegade science, urging scientists and policy makers to “condemn rogue experimentation that takes advantage of families’ misplaced trust in people who wear white coats.” CGS executive director Marcy Darnovsky, PhD, stated,

No researcher or doctor has the right to flout agreed-upon rules and make up their own. This is an irresponsible and unethical act, and sets a dangerous precedent.

Paul Knoepfler, Professor in the Department of Cell Biology and Human Anatomy at UC Davis, expressed his deep concern about the ethics and safety of the procedure on his blog, emphasizing the need to recognize it for what it is, namely a “living human experiment” that has produced “a genetically modified human being.”

David King, PhD, director of the UK watchdog group Human Genetics Alert, issued a press statement condemning the news, stating,

This is entrepreneurial reproductive technology at its most unethical and irresponsible.  It is outrageous that they simply ignored the cautious approach of US regulators and went to Mexico, because they think they know better. Since when is a simplistic “to save lives is the ethical thing to do” a balanced medical ethics approach, especially when no lives were being saved? These scientists have used an experimental technique that many scientists still think is unsafe, in order to create a world first. When are the world's governments going to stop rogue scientists crossing crucial ethical lines?

Finally, in an invited article in the Deccan Chronicle, Biopolitical Times contributor Pete Shanks wrote:

What we now know for certain is that national regulations without international cooperation may be almost useless in today’s interconnected world. Meanwhile, gene-editing technology is advancing rapidly…. Among the most worrying possibilities is the creation of children with genetic modifications that could change forever what it means to be human. “Designer babies”, for short.

What if we come to a consensus about what should not be allowed… and then some renegade scientists, convinced that they know best, just go ahead and do it?

Previously on Biopolitical Times:

Image via Pixabay

CRISPR Embryos at Karolinska: Controversies Demand Oversight

Posted by Elliot Hosman on October 7th, 2016

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Rumors have been circulating since 2014 about various research teams around the world applying the genetic engineering tool CRISPR-Cas9 in human embryos. Surprisingly, only two experiments have been officially reported in scientific journals—both of them in nonviable embryos incapable of being used for reproduction, and both out of Guangzhou, China.

CRISPR in viable human embryos

On September 22, NPR’s Rob Stein reported an exclusive look inside the Karolinska Institute in Sweden at ongoing but previously undisclosed work using CRISPR in viable human embryos. Stein had traveled to Stockholm to interview researcher Fredrik Lanner and his colleagues about their program of injecting CRISPR into viable human embryos to “knock out” genes potentially linked to early development. NPR quoted CGS executive director Marcy Darnovsky who cautioned:

It's a step toward attempts to produce genetically modified human beings. This would be reason for grave concern. … If we're going to be producing genetically modified babies, we are all too likely to find ourselves in a world where those babies are perceived to be biologically superior. And then we're in a world of genetic haves and have-nots...

The next day, Hank Greely, director of the Center for Law and the Biosciences at Stanford University, told Eric Niiler in Seeker that there is “good valid medical use” for basic scientific research using CRISPR in embryos, but followed that with a warning:

Still, Greely acknowledges that some scientists or the public might say that the Swedish experiment could be an ethical "slippery slope" toward a gene-edited human. “Even if you don't intend to, it makes it easier for someone else to do it,” Greely said.

Rogue actors: “Bioethics, get out of the way”

While many scientists, scholars, legal experts, and public interest advocates oppose using human gene editing for reproductive purposes, others question why anyone would dare stand in the way. There are longer and shorter answers. Our knowledge of both CRISPR and genetics/genomics is poor—not  just on its own terms, but also in relation to other spheres of knowledge, particularly the ways in which they each interact with evolution, environments, public health, and social justice. For the foreseeable future, it would be reckless for a scientist to implant CRISPR-injected embryos for pregnancy not only because of serious safety concerns, but also in terms of democratic governance—especially given the select echelons to which most of the debate is currently restricted, and the range of social and political threats that genome editing poses to the human species.

In Seeker, legal scholar Rosario Isasi of the University of Miami voiced concern about edited human embryos being misused to produce genetically modified humans.

What are the oversight and controls to prevent this technology from being misused and go to a stage that, for now, the scientific community has agreed is a no-go?

In the italics (added) above, Isasi refers to the concluding statement from the International Summit on Human Gene Editing in D.C. in December 2015, in which the organizing committee argued:

It would be irresponsible to proceed with any clinical use of germline editing unless and until (i) the relevant safety and efficacy issues have been resolved…and (ii) there is broad societal consensus about the appropriateness of the proposed application.…any clinical use should proceed only under appropriate regulatory oversight.

Ensuring that researchers work within the bounds of existing national and international prohibitions against heritable genetic modifications in early human cells can be difficult when: (1) commercial and reputational incentives interfere, and (2) rogue scientists exploit basic research for socially and scientifically unsafe ends. Isasi noted in Seeker that the Karolinska Institute has been the venue of an ongoing controversy involving Paolo Macchiarini, a stem cell researcher whose implants of artificial trachea into people led to deaths between 2012 and 2014. Isasi asked:

How did they supervise that [artificial trachea] research, which makes me wonder, what mechanisms were in place to oversee this (gene-editing) proposal [?]

Concerns about end runs or misbehavior by individual scientists have recently grown. On September 27, the news heard ‘round the world was that a fertility doctor based in New York City went to Mexico to use scientifically controversial mitochondrial manipulation techniques to produce a child from an embryo engineered from the DNA of three people. New Hope Fertility Clinic’s John Zhang will take the stage and present the methods used to produce this “three-parent baby” at the upcoming conference of the American Society for Reproductive Medicine, the trade organization for fertility practitioners. The scientific portion of the annual meeting this year is aptly titled: "Scaling New Heights in Reproductive Medicine". It will be instructive to see whether Zhang is met with applause for his “disruptive” and “innovative” foray, or whether his colleagues will criticize the ways he short-circuited public policy and democratic discussions of emerging biotechnology regulations.

Clear boundaries - for some

In an interview with Paul Knoepfler, Lanner noted the existing Swedish policy against using modified embryos for pregnancy:

Swedish law is clear that genome editing is only allowed within the first 14 day[s] as long as the embryo is not transferred back for a continued pregnancy. This means that heritable genome editing for clinical purposes would not be allowed in Sweden. The clear legislation has been key in us moving ahead with these plans…. I’m actually pretty skeptical that the technology will be used for genome editing in the early embryo anytime soon.

The situation in China is different. While that country has regulations that would technically ban gene-edited embryos being used for pregnancy, it is unclear whether these regulations are enforced. On September 24, news emerged out of China that a CRISPR testing facility for genetically modified animals was under scrutiny for “faking inspection records and using students instead of certified technicians to conduct tests.” The testing center was established by the Chinese Academy of Agricultural Science, whose website lists partners including the Gates Foundation and UC Davis. It is a subsidiary of the Chinese Academy of Science which co-sponsored last December’s International Summit on Human Gene Editing with the U.S. National Academies and the UK’s Royal Society. Chief researcher Huang Dafang noted:

The incident has exposed management problems of some similar institutes, and serves as a warning…

Where does that leave the U.S.?

Many across the spectrum of opinion have noted the alarming speed with which CRISPR is being applied in research labs, including to human embryos, outside public scrutiny. Absent consistent laws or guidelines, many are concerned that rogue researchers may conclude that it is “safe enough” to implant edited embryos for pregnancy.

Given the competitive pressures in the world of science, the commercial incentives to be “first to market,” and the forum-shopping inherent to today’s biomedical enterprise, the “three-person IVF” child born in Mexico is a cautionary tale. Someone, somewhere could soon decide to try for a CRISPR baby. We should aim to protect future children from being born stripped of their privacy and guaranteed a life of medical display and tracking that was justified on their behalf to service goals like parental genetic connection.

We need a federal ban on any private or publically funded research aimed at clinical tests of human germline interventions and specifically against the use of gene-edited human germ cells in assisted reproduction. We also need an international conversation on how to pressure the biomedical sector in a range of political contexts to stay away from the human germline.

Previously on Biopolitical Times:

Composite image via Pixabay (lungs), Pixabay (baby silhouette), and Flickr/Lisa Camper (DNA)

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