Ethics, Bioethics, and Biomedical Research

Two stories in the past two weeks, one on the therapeutic cloning of human stem cells,¹ and the other on the successful replication of DNA containing two new, non-naturally occurring synthetic DNA bases in a cell² have prompted me to turn to the subject of bioethics.  I have been studying and writing about biotechnology since 1984 and for quite a while people would conflate biotechnology with bioethics. When I would tell people that my area of law was focused on biotechnology, I would frequently get the response, "like designer babies?"   I would respond, "No, that's a bioethics issue, and I rarely do anything ethical."  My joking response was intended to emphasize the distinction between biotechnology, which is simply the use of modern molecular biology as a tool in a variety of areas, from bioethics, which is the effort to analyze issues concerning human life and health in ethical terms. In the 1980's and much of the '90's,  my response was true. The biotechnology industry was focused on healthcare innovation and faced numerous issues concerning intellectual property rights and federal regulation. Very few, if any, of the issues faced by the developing biotechnology industry raised new or difficult ethical issues.  Companies were (and are) trying to develop human therapeutics and diagnostics and the ethical issues were much the same as had faced the pharmaceutical and medical device industry for decades: informed consent; ensuring that clinical trials provided a sufficient potential for good to justify human experimentation; and, providing access to lifesaving drugs in less developed regions of the world. Then, in 1998, James Thompson and others at the University of Wisconsin reported that they had successfully isolated and cultured human embryonic stem cells.³ With that step, some of what biotechnology researchers and companies were attempting to do became embroiled in ethical controversy. Soon afterwards, in 2001, the Human Genome Project announced the completion of the first draft of the complete human genome. Issues of genetic testing and genetic discrimination, which had been simmering for some time, became much more imminent. I could no longer make my joke, as embryonic stem cells and genetic testing were no joking matter and could not be ignored.

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As bioethics moved center stage in the discussion of biotechnology I had to pay attention to the debate and formulate my own views on these issues. I participated in a symposium on From Chance to Choice: Genetics and Justice at the University of San Diego. At that symposium I was privileged to have an opportunity to disagree with Francis Collins, then the director of the Human Genome Project and now the Director of the NIH, about whether or not genetic discrimination in the workplace could ever be ethically justified (he said no and I said yes). In my first publication on a bioethics topic, A Rawlsian Approach to Solving the Problem of Genetic Discrimination in Toxic Workplaces,⁴ I expanded on that argument and asserted that the ethical issues surrounding genetic testing could best be addressed by the application of the rich philosophical framework provided by John Rawls in his Theory of Justice (1971). In later forays into bioethics, for example, in relation to the issue of longevity research,⁵ I have continued to adhere to what I believe is a straightforward and relatively fundamentalist (to use the word in its pure, non-religious sense of sticking to basic principles) approach to various issues. In Western society, there are really only two basic secular (that is to say non-revelation-based) approaches to deciding what is right or good: a utilitarian approach and a Kantian approach.⁶

Let me briefly elaborate on my claim about utilitarian and Kantian approaches being the two fundamental, non-revelation-based ways of analyzing ethical issues in the U.S. and other Western societies. First, I am obviously leaving aside the various religious traditions and their moral or ethical frameworks. As they are "revelation-based" and disagree with one another on many important bioethical questions, there is no possibility of coming to an agreement about questions such as the use of in-vitro fertilization, egg-donation, stem cell research, or other issues, because the "truth" of the Catholic or Jewish or Muslim answers to these issues can never be demonstrated to adherents of other traditions without divine intercession into the debate. In the absence of such a miracle, as a practical matter we can only decide on the goodness or rightness of an answer to a problem based on whether or not it does more overall good than harm (utilitarian) or whether or not it is in conformity with the principle of respecting others as autonomous individuals entitled to pursue their own ends, rather than using others for our ends (Kantian). It is not always obvious what the utilitarian or Kantian answer to a question is, however, we are more or less limited to those alternative approaches along with a number of variations of them.

With that as prologue, what can we say about the latest stem cell development, which is the announcement that two separate teams of scientists had succeeded in "cloning" by replacing the nuclear DNA of an embryonic stem cell with the nuclear DNA from an adult cell? For this discussion of ethics in biomedical research, I will evaluate the ethical issues raised by the work of one of those teams, a group of scientists led by Dieter Egli of the New York Stem Cell Foundation Research Institute. Egli's group replaced the embryonic cell's nucleus with the DNA from a cell of a 32-year-old woman with diabetes, and then succeeded in guiding the resulting cloned cell to differentiate into insulin-producing cells. This research clearly has the potential to lead to breakthrough treatments for diabetes as well as many other human diseases. From a utilitarian perspective, there is the destruction of an embryo originally created for in vitro fertilization by an infertile couple, who no longer wish to use that embryo for conception, weighed against the possible benefit to mature humans suffering from a serious disease that is not completely treatable with existing therapies. This research and future research along these lines is clearly ethical from a utilitarian perspective. It is equally ethical from a Kantian perspective, provided that the relevant autonomous persons, in this case the man and woman whose egg and sperm created the embryo and the diabetic woman whose cells were used as the "donor" DNA, were fully informed of the nature of the research and freely consented to that research without any coercion or duress of any kind. Note that whatever value or rights might be ascribed to the embryo by particular religious traditions, it cannot be said to have a "will" or "autonomy" in a Kantian sense. The donation of the embryo to science is very much the "parents'" autonomous choice, no less than would be the decision of other parents to allow organ donation from their brain-dead infant for medical research.

The second news story that created headlines was about researchers at Scripps Research Institute in La Jolla creating two new DNA building blocks which were successfully incorporated into and replicated by a cell. This synthetic DNA issue is even easier to analyze than the stem cell question. While synthetic biology is often met with alarmed expressions of concern about scientists "playing God," that concern can only be interpreted either as meaning that the accuser believes the scientists performing such research are transgressing some natural law boundary that is revelation-derived (and therefore out of bounds in this discussion) or that such research poses unknowable risks of Frankensteinian consequences. This second concern, that this research, like that of the fictional Dr. Frankenstein, risks unleashing terrible consequences raises the question of the ethics of research that poses uncertain risks. This is primarily a utilitarian problem, not a Kantian one, for no one would seriously suggest that the cells involved have any kind of Kantian right to determine whether or not they are the object of synthetic biology research.

From a utilitarian perspective some questions about uncertain risks can be very difficult to resolve, however, that is not the case here. While experiments in counteracting global warming by spraying the upper atmosphere with sulfur dioxide might well be very difficult to assess within a utilitarian framework because of the uncertainties of climate science,⁷ the synthetic DNA experiment is not at all difficult to assess from a research safety perspective. The synthetic DNA was self-limiting, as the cell could not produce more of it beyond that which it was "fed" by the researchers. It could not create pathogenicity in the cell by any conceivable mechanism. It is very nifty biochemistry. It may transgress a number of religions norms. It is not, however, a serious bioethical dilemma.

1 Monya Baker, Cell lines made by two separate teams could boost the prospects of patient-specific therapies, April 28, 2014, available at http://www.nature.com/news/stem-cells-made-by-cloning-adult-humans-1.15107

2 Andrew Pollack, Scientists Add Letters to DNA’s Alphabet, Raising Hope and Fear, NY Times, May 8, 2014 at A1.

3 James A. Thomson, Joseph Itskovitz-Eldor, Sander S. Shapiro, Michelle A. Waknitz, Jennifer J. Swiergiel, Vivienne S. Marshall, Jeffrey M. Jones, Embryonic Stem Cell Lines Derived from Human Blastocysts, 282:5391 SCIENCE 1145-1147 (November 6, 1998).

4 39 San Diego L. Rev. 747 (2002). If you really want to know how I justified genetic discrimination in the workplace (to exclude those hypersensitive to workplace toxins) you will just have to read the article.

5 Longevity Research and Bioethics, 23 Biotechnology L. Rep. 542 (2004)

6 Rawls' contribution was to demonstrate the possibility of a synthesis of those two approaches using a contractarian framework to construct the good or just society. Rawls reasoned that the just society would maximize overall welfare (a utilitarian virtue) with fundamental respect for all, most significantly by limiting the extent to which those most disadvantaged by nature or fortune suffered as a consequence of their disadvantage (Kantian equality and respect for all). For a further, much more lengthy introduction to Rawls, see Leif Wenar, "John Rawls", The Stanford Encyclopedia of Philosophy (Winter 2013 Edition), Edward N. Zalta (ed.), available at http://plato.stanford.edu/archives/win2013/entries/rawls/.

7See Michael Specter, The Climate Fixers, The NEW YORKER, May 14, 2012 available at http://www.newyorker.com/reporting/2012/05/14/120514fa_fact_specter?currentPage=all