[Paleopsych] Francis Fukuyama: Human biomedicine and the problem of governance.

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Francis Fukuyama: Human biomedicine and the problem of governance.
Perspectives in Biology and Medicine, Spring 2005 v48 i2 p195(6)

I APPRECIATE THE OPPORTUNITY given me by the editors of Perspectives on Biology 
and Medicine to reflect on my experience on the President's Council on 
Bioethics and the work it has produced. In light of the fact that I never 
submitted a personal statement at the time of the publication of the Council's 
2002 report Human Cloning and Human Dignity, I particularly welcome this 
opportunity to clarify my views on this subject.

Contrary to the Council's critics, our group from the beginning had a healthy 
balance of views on the tortured "moral status of the embryo" question. 
Unsurprisingly for a panel nominated by a pro-fife President, there was a 
strong minority committed to the view that full human status began at 
conception. But there was another equally strong minority that believed 
strongly that embryos had no particular moral status and could be cloned or 
otherwise used for stem cell research. I found myself, with several other 
members of the Council, in between these camps. I believe that human embryos 
have an intermediate moral status: they are not the moral equivalents of 
infants, nor are they simply clumps of cells like any other tissue sample that 
can be used and discarded at will. There are other things that have a similar 
intermediate moral status. Human cadavers, for example, can be used 
instrumentally in the training of medical students or for research, but they 
cannot be disposed of at will and must be treated at all times with a certain 
degree of respect. For reasons that I lay out more systematically in my book 
Our Posthuman Future (2002), I believe that full moral status is something that 
is gradually acquired over time (both developmental and evolutionary). Human 
beings acquire it gradually during prenatal development, and do not stop 
acquiring it even at birth. This gradual acquisition of moral status is 
reflected in the fact that we give full political rights only to adults and not 
to children.

The implication of an embryo's intermediate moral status is that it can be used 
instrumentally, but only for serious purposes and with a certain degree of 
respect due an entity that has the potential to become a full human being. I 
believe that embryos can be used as a source of stem cells for research, but 
that the process ought to be under social control to ensure that these serious 
purposes are met. This means, at a minimum, a regulatory system that keeps 
track of embryos and makes sure that they are not used for purposes other than 
serious scientific research (e.g., implantation to produce a child). Such a 
regulatory system would solve the enforcement problem with respect to 
reproductive cloning, which was one of the reasons I had earlier supported a 
broad cloning ban.

While I have a number of ethical objections to reproductive cloning, I do not 
oppose research cloning per se. My objections are largely consequential. I am 
concerned about the precedent that this kind of cloning will have for other 
types of research further down the road: having permitted the creation of 
cloned embryos in order to harvest stem cells, will we at some point want to 
clone fetuses to harvest complete organs and tissues? No one today advocates 
this, but people's moral principles tend not to be deeply grounded when there 
are research incentives weighing on the other side. Not long ago those 
advocating stem cell research swore that they would draw the line at research 
cloning, but soon found the latter quite acceptable when the need arose.

I voted, with a majority of the Council, in favor of a recommendation to the 
President to support a total ban on reproductive cloning and a four-year 
moratorium on research cloning. While other members of the Council who shared 
my views on the intermediate moral status of embryos voted to permit research 
cloning, I supported the moratorium for a number of prudential reasons.

First, it seemed to me that a four-year moratorium would not seriously slow 
down the pace of research in this area. Supporters of stem cell research and 
research cloning are guilty of going way beyond what they know about the likely 
benefits of these activities, and of minimizing the length of time that would 
be required to realize them. Given President Bush's August 9, 2001, decision 
that liberalized existing rules on federally funded stem cell research, it 
would require at least four years to categorize existing lines and fund 
significant research on them. By that point, we would be in a much better 
position to know exactly how promising this research was, and whether there 
were other approaches, such as work on adult stem cells, that would yield 
comparable results. If it became clear at the end of four years that we needed 
to move ahead, then I would support lifting the moratorium.

A second prudential reason for having a four-year moratorium had to do with the 
length of time needed to set up an appropriate regulatory system. One of my 
consistent interests during my tenure on the Council has been to promote an 
updating and modernization of the U.S. regulatory system for human biomedicine, 
particularly as it relates to embryo research. As noted earlier, my view that 
human embryos have an intermediate moral status implies that while embryos can 
be used instrumentally for research, this activity ought to be closely 
supervised by a public authority. While supporters of research cloning pay lip 
service to the need for a regulatory framework, they do not take seriously the 
amount of time and effort required to create a good one. Four years to me was 
the minimum amount of time needed to establish such a regulatory body; similar 
efforts in Britain (to create the Human Fertilisation and Embryology Authority, 
HFEA) and in Canada (the Assisted Reproduction Agency of Canada) had taken even 
longer.

More than two years have passed since the Council issued its cloning report, 
and nothing has happened. The two bills introduced into Congress in 2001, the 
first banning both reproductive and research cloning and the second banning 
only reproductive cloning, remain stuck in the Senate. The Council's proposal 
for a four-year moratorium, which was offered as a means of breaking this 
deadlock, was not taken up; there has been no work on designing a new 
regulatory system; and there has been no change in President Bush's stem cell 
policy.

The Council made a second effort to get around the logjam with its last report 
Reproduction and Responsibility (2004). That report defined a number of 
reproductive possibilities that everyone on the Council agreed were morally 
unacceptable today, and it urged Congress to move forward with possible 
legislative action in a way that would not prejudice a decision on the 
acceptability of embryo research or cloning. This too, unfortunately, has also 
fallen afoul of embryo politics and is unlikely to lead to any legislative 
action.

Even the modest steps outlined in Reproduction and Responsibility would have 
been only the beginning of a more comprehensive regulatory approach that in my 
view is needed. Technology will continue to move quickly and pose new ethical 
challenges in the coming years, as well as substantial opportunities for new 
cures and treatments. Congress cannot intervene legislatively in response to 
each new technological development that comes along; it does not have the time, 
interest, or expertise to debate any but the most important. What is needed is 
the ability to delegate to a regulatory agency responsibility for making 
decisions on more routine kinds of issues, based on broad guidelines set by 
Congress. This is the model followed by Britain's HFEA, as well as the 
regulatory authorities in any number of other industrialized democracies.

Our current regulatory system is a patchwork of excellent--indeed, sometimes 
excessive--regulation, and in other areas underregulation. The Federal Drug 
Adminstration represents a "gold standard" in the regulation of drugs and 
medical devices; on the other hand, it does not regulate the practice of 
medicine and therefore leaves entire areas like assisted reproduction 
essentially unregulated. In addition, the FDA's statute allows it to regulate 
only on the basis of safety and efficacy, and not on normative grounds. The 
National Institutes of Health, by contrast, does have a broader authority to 
regulate on the basis of ethical concerns, but its jurisdiction extends only to 
federally funded research.

It remains my belief that the United States needs to rethink its entire system 
for regulating human biomedicine in light of technological advances that are 
either here today or will arrive over the coming years. As a general rule, we 
should not invite more regulation than is absolutely necessary so as not to 
hold back important scientific inquiry. But regulation can also facilitate 
research and future individual choice by assuring the public that the former is 
being done responsibly and within the bounds set by the broader community.

What a revised regulatory system would look like is well beyond the scope of 
the present article. I am currently directing a foundation-sponsored study on 
the governance of human biotechnologies, which will outline options and 
elaborate a concrete proposal at greater length. Briefly, I believe that the 
institutional design of a new regulator must address several different 
concerns.

First, the type of decisions delegated to the regulatory authority need to be 
ones on which there is broad societal consensus, though not necessarily 
detailed knowledge or agreement. The regulator must be shielded from having to 
pass judgment on highly controversial issues such as the moral status of 
embryos, since this is a matter that needs to be adjudicated by the country's 
central political institutions (i.e., Congress and the courts). The same 
institution can facilitate or prohibit stem cell research, research cloning, 
and a host of other procedures. British regulators facilitate research cloning; 
Canadian regulators prohibit it. But there has to be agreement on the ends that 
the regulation is meant to serve before there can be delegated authority.

Second, there needs to be a broadening of participation in the regulator's 
decision-making procedures. In a liberal democracy like the United States, the 
people, through their elected representatives, are ultimately sovereign, but 
they typically delegate substantial regulatory powers to the epistemic 
communities involved in a particular scientific or industrial sectors. This 
stands to reason, since the epistemic communities are the ones who possess 
knowledge about the field and have a strong self-interest in the nature of 
state oversight. This is nowhere more true than in a field like human 
biomedicine.

A new institutional design will have to continue to vest great authority in the 
existing epistemic communities (i.e., the scientific research community, the 
medical community, and the pharmaceutical and biotechnology industries); the 
question is whether it is possible to broaden participation in agency oversight 
to include other societal stakeholders, such that the regulator would be more 
broadly representative of the whole community. Members of the epistemic 
communities are highly knowledgeable, but their interests do not necessarily 
represent the interests of society as a whole.

There are many approaches that have been taken to the question of public 
participation, from the lay members of institutional review boards to the 
public notice and comment period that is part of the Administrative Procedures 
Act. In Britain, the government-appointed board of the HFEA is supposed to 
represent a mixture of views broadly representative of British society (though 
whether it achieves this end is contested). None of these is fully 
satisfactory: those members of the general public that do not have a direct 
interest in the subject are usually insufficiently knowledgeable to participate 
meaningfully, and there is always the question of who selects the members of 
the board and how the selection process can be shielded from excessive 
political influence. In the area of human biomedicine, there is a particular 
problem that the existing organized interest groups (the scientific research 
community, the biotech industry, and various pro-life groups) are much more 
politically polarized than the American public in general. Therefore opening up 
"public participation" to input from these groups alone will not necessarily 
provide clear insight into what the American public really wants.

Designs for new institutions typically do not spring from the pens of public 
policy analysts; they are highly dependent on historical precedents and 
traditions, require extensive discussion and consultation, and are subject to 
the give-and-take of politics. It was my hope that the President's Council, 
like Britain's Warnock Commission in the 1980s that paved the way for the HFEA, 
could have been the vehicle for at least initiating a discussion of new 
institutions. There are a host of political reasons why this was not possible, 
beginning with the fact that abortion and embryo politics are much more 
controversial issues here than in the United Kingdom. (1) It may be that 
serious legislative action on this front will have to await a scandal or 
setback on the scale of thalidomide or Willowbrook before a political consensus 
develops in favor of action. It would be far better, of course, if we could be 
proactive in anticipating such problems, but that is unfortunately not the way 
our democracy has always worked in the past. This, then, will have to be a 
topic to be taken up by future bodies bioethics advisory bodies similar to the 
President's Council.

I would like to conclude by saying something about the nature of debate and 
discussion on the President's Council. A number of critics, including some 
members of the Council, have charged that the Council was stacked with pro-life 
ideologues who were hostile to science, and that opposing views were not fairly 
represented. As my account of the debate over the cloning report indicates, 
this was far from the truth. There was always a remarkable diversity of opinion 
among the Council members. In my personal experience, the Council's chairman, 
Leon Kass, and his staff were unfailingly evenhanded in their treatment of 
Council members and bent over backwards to take account of their views in 
Council documents. Some of the most genuinely interesting discussions that I 
have ever participated in--not just of bioethics but of philosophic and pubic 
policy issues more broadly--took place around the Council's table. One has only 
to read through the transcripts of the meetings to see the richness of the 
discussion, and how so much of it transcended the kinds of ideological debates 
to which Americans have become accustomed. Several of the Council's 
publications, including Beyond Therapy (President's Council 2003b) and the 
Being Human reader (President's Council 2003a), contain writing of a subtlety 
and nuance that I never thought I would see in a document published by the U.S. 
government. Whatever my frustrations with not being able to go further on 
regulatory issues, it has been an honor and a pleasure to serve on the Council 
and to be part of its work.

(1) In saying this, I do not in any way mean to blame only the pro-life side 
for preventing consideration of this issue. Pro-choice advocates would be 
equally suspicious of a broad effort by the government to monitor and regulate 
the area of assisted reproduction.

REFERENCES

Fukuyama, F. 2002. Our posthuman future: Consequences of the biotechnology 
revolution. New York: Farrar, Straus and Giroux.

President's Council on Bioethics. 2002. Human cloning and human dignity: An 
ethical inquiry. Washington, DC: President's Council on Bioethics. Repr. New 
York: Public Affairs, 2002. 
http://www.bioethics.gov/reports/cloningreport/index.html.

President's Council of Bioethics. 2003a. Being human: Readings from the 
President's Council on Bioethics. Washington, DC: President's Council on 
Bioethics.

President's Council on Bioethics. 2003b. Beyond therapy: Biotechnology and the 
pursuit of happiness. Washington, DC: President's Council on Bioethics. Repr. 
New York: HarperCollins, 2003. 
http://www.bioethics.gov/reports/beyondtherapy/index.html.

President's Council on Bioethics. 2004. Reproduction and responsibility: The 
regulation of new biotechnologies. Washington, DC: President's Council on 
Bioethics. 
http://www.bioethics.gov/reports/reproductionandresponsibility/index.html.

Bernard L. Schwartz Professor of International Political Economy at the Paul H. 
Nitze School of Advanced International Studies, Johns Hopkins University; 
Director of the Human Biotechnology Governance Project, 1619 Massachusetts 
Avenue NW, Washington, DC 20036.

E-mail: fukuyama at jhu.edu.

Web site for the Human Biotechnology Governance Project: 
http://www.biotechgov.org.