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MARK D. UEHLING, Bio·IT World senior science editor, spoke with Fukuyama recently about the prospect of ethics regulation in biotechnology.
June 11, 2002 | A conversation with political scientist Francis Fukuyama can be sobering. The topics include Nazi scientists and reproductive cloning, Ritalin and Prozac, cannibalism and Scientology. A professor at Johns Hopkins University and a member of President Bush's Council on Bioethics, Fukuyama argues that biotechnology cannot regulate itself.

Fukuyama was formerly a diplomat with the U.S. State Department and an analyst at the Rand Corporation. In 1992, he published The End of History. Released in 20 countries, the book was an unlikely bestseller in the policy-making arena. Its thesis: Democracy was the only viable organizing principle for governments following the collapse of communism. Fukuyama's new book, Our Posthuman Future, is a deliberately provocative tract intended to wrestle the cloning debate away from the experts. Critical of the ethical and philosophical sophistication of leading scientists and engineers, he predicts that an absence of federal oversight of cloning will result in a medical tragedy.

Q: IT has traditionally not been heavily regulated, but you think biotech needs more rules. When does an industry need tighter supervision?
A: I had a conference on this in the fall, where I tried to get people from IT and biotech together to think about precisely this question. Economists would have one framework, negative externalities. If there are certain types of unregulated harms that come from an activity, then you have reason to step in. In an industry that is relatively small and homogenous and well-defined, you can get pretty good levels of self-regulation. But in one that is very heterogeneous and large and globalized, it's much harder to get that kind of internal consensus to produce strong internal policing.

Q: Are Americans too infatuated with technology to regulate it effectively?
A: I like technology myself. Part of the current fascination with technology is based on our recent experience with IT, which doesn't produce that much by way of social harm. Therefore Americans have said, quite rightly, it's good we didn't regulate IT the way Europeans did.

In the case of genetically modified foods, the Europeans regulate them much more heavily. A lot of Americans think that is simply cultural or irrational. But it's not: The Europeans have had the most recent scandals in the regulatory agencies telling them something was safe when it wasn't, such as BSE [bovine spongiform encephalopathy, or mad cow disease], or the French blood supply [infected with HIV]. We haven't had this kind of regulatory disaster since Three Mile Island or Love Canal. That's what accounts for the difference in perception.

Excerpt from Our Posthuman Future: 
How to prevent a biotechnological Three Mile Island:

"The history of pharmaceutical regulation was driven by horror stories like the sulfanilamide elixir and thalidomide. It may be the case that regulations concerning human cloning will have to await the birth of a horribly deformed child who is the product of an unsuccessful cloning attempt. The biotech industry needs to consider whether it is better to anticipate such problems now and work toward formulating a system that serves its interests by assuring people of the safety and ethical nature of its products, or wait until there is a huge public outcry following an outrageous accident or horrifying experiment."

Q: You see Monsanto's experience with genetically engineered crops as a parable?
A: Monsanto and Three Mile Island are the two precedents. If Monsanto had decided to go for some fairly modest form of regulation, like labeling requirements, back in the early '90s, then they probably wouldn't have found themselves shut out of the European market as they are now. There are a number of unpleasant things that you could imagine happening in the biotech industry.

Up until Three Mile Island, the nuclear power industry asserted that nuclear power was safe, and that all the science was on their side. After [Three Mile Island] happened, the industry actually took a lot of steps to police themselves. There is now a World Association of Nuclear Operators and safety standards for the industry that are much more stringent than any of the government-mandated standards. They realized they had been wrong prior to that accident. It is difficult to get industries to anticipate things. The regulation usually depends on a disaster happening, like thalidomide or the Tuskegee syphilis study.

Q: In your book, you argue that the cloning debate should not be dominated by religious activists or ideas. Is that realistic in the current political climate?
A: I don't want to cut religious ideas out. A lot of cloning people have gotten this idea that the only ethical concerns are those raised by religious people. My interest was trying to indicate to people that there are nonreligious reasons for worrying about this technology.

Q: Is there really one steady, static human genetic inheritance from which we are now, in your view, departing?
A: I don't think we are frozen. I do think, however, that for the 50,000 years since you've had recognizable human beings, that genetically we're not all that different on that time scale. Even the most committed Darwinist believes in the existence of a human essence on which they base their notion of human rights.

Q: Cloning is controversial. But the ideas of Galileo and Darwin were upsetting at first, then gradually accepted. Could cloning eventually become no big deal?
A: There are instinctive moral ideas, such as the aversion to incest or infanticide or cannibalism, that have been pretty constant through history. But I take your point — it is possible people will get used to this.

I don't have very strong views on why people shouldn't do research on therapeutic cloning. But I do worry about the desensitization effect. So in five years some researcher may say we need to grow not just embryos but fetuses with a certain genetic signature, and this time we're going to harvest entire organs, and tissues, out of the fetus, and do that and then destroy [the fetuses]. A lot of things that are unthinkable now may become thinkable down the road.

Q: You refer in the book to Nazi scientists more than once. Do you feel there are echoes of what the Nazis did in today's biotechnology labs?
A: That comparison is not apt. It will add a lot of heat and no clarification at all to make that comparison. The cases are rather different.

If you look at the Nazi scientists, a lot of them were fairly serious researchers, and they found they had this opportunity to conduct double-blind clinical trials without voluntary consent of the people involved, and they took advantage of it. They didn't think about the ethical dimension of it. That sort of thing has happened in the U.S. — the Tuskegee syphilis scandal. It's not the case that American biomedical researchers are above that sort of thing. In general, however, we live in a liberal democracy that has a lot of institutional safeguards against those sorts of abuses. We also live in a society where the norms are such that even without those institutional safeguards, there are a lot of internal constraints.

Q: You suggest the legal interests of parents and children, once presumed to be identical, are about to diverge — especially if a child has been created for an organ. Is this one reason government must get involved?
A: This is not a new issue in the law. We have laws against incest and child abuse. Already there is a set of laws intended to protect children from their natural parents because you cannot in all circumstances assume parents will do everything that is in the best interest of their children. If you look at the theory of when the state ought to intervene, it's cases where the child is not in a position to assert his or her rights against the parent.

Q: Are you optimistic that Congress can navigate this territory?
A: I don't know if Congress can navigate. But I think they ought to. It has been very convenient for the scientists to keep outsiders out of their domain. In a democracy, and particularly with the technology moving ahead as fast as it is, it is irresponsible to delegate decision-making to that expert group. Their interests are just not necessarily in sync with the public's interests.

Q: What are the scientists' interests?
A: It's not that they are evilly intentioned or anything. But the biotech industry is in it to make money. The scientists have an interest in honor and fame. They want to push back the frontier of knowledge for its own sake. It is quite important that people outside of that community start thinking about this, start educating themselves and expressing opinions. Because up until now it has been the domain of this expert group. I think it cannot remain that way.

Q: You serve on President Bush's Council on Bioethics. How do you reconcile your suspicion of bioethicists with that role?
A: I don't regard myself as a bioethicist. I'm a political scientist who's gotten interested in these issues. I don't kid myself that this council is ultimately going to have a terribly great influence over these technologies. I think it will play some role in stimulating more balanced debate than in the past.

Q: You recommend a new U.S. agency that might be called the Human Fertilization and Embryology Authority. Do we need a new bureaucracy to exercise control over other bureaucracies?
A: It may not be politically possible to bring something like this about. It's been a long time since anyone has said, 'What we need in this country is more regulation.' But when you start thinking through this problem, I don't see what other conclusion you can come to. It may be it's not politically feasible to move down this path until there is a big scandal or screwup.

Q: Could you see the Supreme Court ruling on whether it is legal to clone your pet, your wife, your child?
A: That possibility — that the courts would find a right to clone yourself already in the Constitution — has been suggested by a number of people. Nobody knows if a court would take it into its own hands. I would think, however, after all of the controversy that was engendered by Roe v. Wade, that courts do tend to be fairly cautious about inventing social policy. I hope it's not going to be through the courts. That's not a good way to make public policy. Congress ought to act one way or the other.

Q: You believe Britain might become more of a haven for biotechnology?
A: They have a more permissive set of rules, and they have a very well-developed scientific research community. A lot of Americans would be happy to go to Britain if they could get the funding to do their research. That's when you get this jurisdictional arbitrage —

Q: — meaning that nations with strict rules will lose talented researchers to nations with looser rules?
A: It shouldn't be allowed to trump all other arguments. It is a real concern. But the reason a researcher locates in a particular area has partly to do with the rules but also to do with the density of other kinds of similar activities going on. There are other factors besides the kinds of regulatory environments.

Q: You are concerned about the use of Ritalin and Prozac. Is taking Ritalin one step on the slippery slope to not being human?
A: Those drugs allow you to start doing things like modifying human personality and using very sophisticated understanding of brain chemistry to modify human behavior. The way people deal with this will give us some indication of the way they deal with other, more powerful technologies. I'm not a Scientologist who says [Ritalin] is inherently evil. I just think it's a very interesting precursor of other things that are likely to be coming at us later.

Q: Pre-implantation techniques, in which human embryos are tested in vitro for certain characteristics, seems like an emerging issue for you.
A: That actually happened after I finished writing the book. There was a case of a woman with early-onset Alzheimer's. She implanted an embryo that was free of that particular defect. I think it's fine to do that. That technology is going to give you a lot of choices about screening for sex or other enhancement values that don't have the clear therapeutic value that this case had. It's reasonable to ask whether we don't want some rules.


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