Incurious about Ethics?

By Marcy Darnovsky | 04.09.2015

Biopolitical Times

https://www.geneticsandsociety.org/biopolitical-times/incurious-about-e…

An Institute of Medicine committee is in the midst of a 19-month study, undertaken at the FDA’s request, of the “ethical and social policy considerations” of germline-modifying techniques that cobble together gametes or embryos produced with eggs from two women. The committee held its first public meeting on March 31 and April 1, in the wake of statements of concern about human germline gene editing by several groups of prominent scientists.

Presumably because of the Center for Genetics and Society’s longstanding interest in the techniques and their serious implications, I was invited to speak on a panel about human germline modification. The materials I received in preparation for the meeting included questions about the social and ethical implications of modifying genes that are inherited by future generations, and about the historical context of the prohibitions against human germline modification that have been put in place by several international human rights treaties and dozens of countries (though not the US).

Another question was whether it would be “advisable” to draw policy lines between therapeutic and enhancement applications of genetic modification techniques, the implication being that this might be preferable to the current widespread agreement that encourages gene transfer to treat sick people, but puts off limits changes that would be passed on to children and subsequent generations. Several invited speakers addressed these questions from a cautionary perspective; see, for examples, here and here.

Unfortunately, most of the IOM committee members seemed remarkably incurious about these points. Few follow-up questions were asked about the societal implications of human germline modification, or about the social values and concerns that have prompted more than 40 countries to adopt laws against it. Committee members didn’t inquire, let alone probe, about the effects of violating this prevailing policy agreement, or about the commercial and social dynamics that might come into play if human germline modification were to be introduced into fertility clinics.

There was, however, a framework of value-laden assumptions that seemed to guide many committee members. In this framework, ethical considerations center on relationships between physicians and their patients, and between researchers and their human subjects (in this case, with parents acting as proxies for their future children). Thus the overwhelming majority of committee members’ comments and questions about ethics involved matters of informed consent, acceptable risk, and whether it was permissible for parents to be required or encouraged to permit medical follow-up of any children produced as a result of germline mitochondrial manipulation.

In short, “ethical considerations” were largely equated with “research ethics,” a critically important but ultimately narrow set of guidelines that is indifferent – and sometimes hostile – to broader social concerns. Within this research ethics framework, the plans and prerogatives of scientists are subject to limits only when there is clear evidence that they are likely to directly harm individuals.

Also central to many committee members’ thinking are those parental desires for genetically related children. For some, such desires trump even the fact that trying to fulfill them would put any resulting children at significant risk. From this perspective, the risks to a child born as a result of mitochondrial manipulation should be weighed against the burden of mitochondrial disease. Of course, this logic assumes both that people at risk of passing on mitochondrial disease have no alternatives, and that the desire for a child who is not just healthy but full genetically related is paramount.

In fact, there is a much less risky way for the overwhelming majority of women with mutated mitochondria to have healthy and genetically related children. But this was also curiously under-explored. Some speakers simply ignored the availability of pre-implantation genetic diagnosis (PGD), an embryo-screening technique that can identify “healthy” embryos for almost all affected women. Another speaker, a proponent of moving ahead with mitochondrial manipulations, went into some detail about the successful use of PGD in Europe for preventing the transmission of mitochondrial disease. But his remarks failed to prompt any reconsideration of the need for germline mitochondrial techniques.

One of the final invited speakers, University of Texas bioethicist John Robertson, is known for his theory of “procreative liberty,” which elevates the desire of some parents for a genetically related child to a right that should be constitutionally protected. Although risks to women and offspring can be taken into account, Robertson argued, any other concerns are “airy” and “moralistic.”

The FDA commissioned the IOM study because its own focus is supposed to be safety and efficacy, and because it recognized the salience and critical importance of broader concerns about mitochondrial manipulation techniques after they came up repeatedly at its February 2014 Advisory Committee meeting. Taken as a whole, the day-and-a-half conversation at the recent IOM meeting leaves a lot of room for a more thorough exploration of the “ethical and social policy considerations” of these germline-modifying techniques. The IOM committee plans another three meetings before it develops its report to the FDA. So there’s still time, if there’s interest and willingness.