Biotechnology

Medievalizing Biotech Regulation

Francis Fukuyama wants to control your reproductive decisions.

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"We are proposing a new regulatory institution in Washington, DC," said Francis Fukuyama, professor of political economy at the Johns Hopkins University School of Advanced International Studies and author of Our Posthuman Future. "It's been a long time since anyone has done that."

What needs regulating? Human biotechnology. Fukuyama unveiled his plan for a new agency at a conference held at the Rayburn House Office building on Capitol Hill. The blueprint for the new biotech regulatory agency being proposed by Fukuyama and Swiss technology consultant Franco Furger is laid out in a 400 page book, Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies.

Why do we need a new biotech regulatory agency? Because bad things have happened? Not at all. In fact, Fukuyama wants to put his proposal in play now so that the denizens of Capitol Hill can simply pull it off the shelf and enact it into law when some sort of biotech scandal erupts. The proposed agency is explicitly modeled after the British Human Fertilisation and Embryology Authority (HEFA). Fukuyama's new agency would not just regulate the safety and efficacy of new biotechnologies, but also rule on their ethical propriety. According to Fukuyama, biotechnology is "galloping ahead" and it's time to move from ethical discussions to regulation and "social control."

Furger discussed some recent developments to illustrate how biotech is galloping ahead. For example, a Texas fertility clinic is now offering embryos for sale; researchers have manufactured mouse sperm from stem cells; and others have inserted human cell nuclei into rabbit eggs to try to produce stem cells. Furger said that he was listing these activities, "not to say that they are reproachable. Some may be acceptable and some not." He asked, "But how do we make that determination?"

Fukuyama explained that the new agency would regulate anything having to do with assisted reproduction techniques (ART). This would include IVF, ooplasm transfer, sex selection either by pre-implantation genetic diagnosis (PGD) or sperm sorting. The agency would also regulate research involving human reproductive tissues including all embryonic stem cell research and anything dealing with human developmental biology.

"Biotech has reached point where existing regulators, the Food and Drug Administration and the National Institutes of Health, can't handle it," declared Fukuyama.The agency would be guided by a set of ranked ethical principles. Its first concern would be the well-being and health of children. Second, ensuring equal access to ART for infertile couples. Third, protecting the well-being of and health of women. Fourth, promoting therapeutic uses of ART over enhancement uses. Fifth, making sure that patients and research subjects give their free informed consent to procedures. And finally, advocating for regulations to limit the commercialization of human eggs, sperm and embryos.

Fukuyama would completely ban human reproductive cloning, the creation of human animal chimeras for the purpose of reproduction, germline genetic modifications, any procedure that would alter the genetic relationship of parents to children, and the patenting of human embryos.

The new agency would regulate research cloning, PGD, sex selection of embryos, and the commercialization of certain elements of human reproduction such as the sale of eggs, sperm and embryos. It would consist of a set of commissioners, appointed by the president and advised by a board consisting of various stakeholder groups such as patients, ART practitioners, scientific community and the biotech industry. Fukuyama also introduced a novel set of mechanisms for consulting with the wider public including deliberative panels and a consultative college of consisting of randomly selected members of the public who convene to consider regulatory issues over the internet.

Instead of inhibiting research and the development of new treatments, the new agency could spur them on, suggested Fukuyama. For example, he asserted that Britain is ahead of the United States in human embryonic stem cell research because of the HFEA's regulations. Fukuyama is just plain wrong about that. The Guardian reported last week, "Excessive bureaucracy imposed by the Human Fertilisation and Embryology Authority [is] prohibiting development in stem cell research and threatening Britain's position as a world leader in the field." The Guardian quoted stem cell researcher Alison Murdoch, director of the Newcastle Centre for Life fertility clinic, as saying, "The way the government has handled the work we do is to regulate it to the point that it looks like it's got barbed wire around it."

But what about the larger question: Do we really want a federal agency making and imposing ethical decisions about human reproduction? Consider the wretched history of federal and state regulation in this area. In 1873, Congress passed the Comstock Laws that outlawed "every obscene, lewd, or lascivious, and every filthy book, pamphlet, picture, paper, letter, writing, print, or other publication of an indecent character, and every article or thing designed, adapted, or intended for preventing conception or producing abortion." The Comstock Laws authorized the U.S. Post Office to confiscate any publications providing advice on contraception and condoms shipped through the mail. The first eugenics law was passed in Indiana in 1907 and eventually laws allowing the forced sterilization of "unfit" people were adopted by 30 states. Infamously, the U.S. Supreme Court upheld forced sterilization in the case of Buck v. Bell in 1927. By the 1960s, some 66,000 Americans had been forcibly neutered.

In the last half of the 20th century, the U.S. Supreme Court finally stepped in to overrule state interference in the reproductive decisions of Americans. In 1965, the Court found unconstitutional the Connecticut law prohibiting use of birth control by married couples in Griswold v. Connecticut. In 1967, the Court ruled in Loving v. Virginia that the laws in 16 states banning interracial marriage were unconstitutional. In 1972, the Court struck down in the case of Eisenstadt v. Baird a Massachusetts law prohibiting the sale of contraceptives to unmarried people. And of course, the Supreme Court found prohibitions on abortion unconstitutional in 1973 in Roe v. Wade.

The HFEA, the model for Fukuyama's new biotech regulatory agency, has similarly interfered with the reproductive decisions of British people. The HFEA has told couples that they could not select the sex of embryos to be implanted. Even now the parents wanting to use PGD to insure that their children will not be burdened with an inherited genetic disease must apply for permission from the HFEA. And the HFEA has banned paying women for providing eggs to be used in research.

Fukuyama's agency would rule not only on safety and efficacy but on moral questions surrounding human reproduction. Some possible techniques are objectionable and should be banned, e.g., any attempt to create a half-human half-chimp baby. On the other hand, Fukuyama wants to ban ever allowing parents to safely choose genes that would tend to give their children healthier immune systems, stronger bodies and cleverer brains.

It turns out that the proposed agency is largely just a vehicle for Fukuyama to impose his moral choices on other people. What Fukuyama is proposing is a step backward to the bad old days in which strangers get to vote on what kind of children their fellow citizens will be allowed to bring into the world. A government bureaucracy, rather than parents, would get to make eugenic decisions. As the sorry history of attempts to regulate human reproduction shows, the truly moral thing to do is fiercely resist this proposal.

Ronald Bailey is Reason's science correspondent. His book Liberation Biology: The Scientific and Moral Case for the Biotech Revolution is now available from Prometheus Books.

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