Tough task: advancing the debate over cloning embryos

President's bioethics advisers weigh in, proposing four-year moratorium to review direction of research, societal concerns

Americans almost unanimously turn thumbs down on the cloning of human babies. But when it comes to cloning human embryos for use in biomedical research, they are sharply and emotionally divided.

While some oppose cloning as the irreversible crossing of a moral boundary, others back it as scientific freedom essential to pave the way to life-saving therapies.

Now President Bush's handpicked council of bioethics advisers has jumped into the fray. While the council, too, was sharply split, last week it proposed a compromise: a four-year moratorium on cloning embryos for research. The purpose would be to allow a national debate on the direction of research and how much society should exercise control over it. And it called for a federal review of other reproductive technologies with potential for making genetic changes in children.

Pleasing neither those who want a total cloning ban (Mr. Bush included) nor those who see a moratorium as stopping progress, the panel seemed intent on setting the stage for greater oversight of the biomedical community. As Leon Kass, the bioethicist who chairs the council, once testified: "We have a golden opportunity to exercise deliberate human command over where biotechnology may be taking us."

"The most important part of this report is the call for regulation – even those who want to go ahead with research agree there has to be regulation," says George Annas, an expert on health law at Boston University. "We certainly haven't had a national debate about how to regulate" the use of these technologies.

While the US leads the world in biomedical research, other countries are ahead in taking a more comprehensive, societal look at the implications of new technologies and in setting public policy.

"Canada had a lively national debate on all these issues of assisted reproductive technologies, which was carried out by a commission with public consultation and focus groups," says Lori Knowles, associate for law at the Hastings Center, a bioethics think tank in Garrison, N.Y. "The same happened in the United Kingdom."

She and her colleagues have just completed a two-year international project comparing regulatory approaches in this field. "This hasn't been done in the US partly because of the abortion issue, but also because of the antigovernment, antiregulation [environment] that is part of the American scene," she says.

But with two fertility doctors claiming they are in the process of cloning babies, and with heightened concern over bioterrorism and other misuses of research, people are beginning to acknowledge a need for oversight of private as well as publicly funded research.

"There are some cowboy clinics out there," Ms. Knowles says, "and there seems to be this groundswell, including some people in the business ... for setting up limits for everybody."

But Congress is stalled on this issue. The House passed a bill last year banning all cloning and setting strict criminal penalties. One Senate bill would do the same, but a competing bill bans reproductive cloning while supporting cloning for research. Neither yet has the 60 votes needed for passage.

The report "will only influence the debate if the president himself buys into the moratorium and recommends it to Congress," Dr. Annas says. "That's not beyond the realm of possibility."

But the proposed compromise is anathema to many.

"A moratorium would enormously set back science in this country – it would be devastating," says Rudolph Jaenisch, professor of biology at the Massachusetts Institute of Technology. "This is a hot field and very serious people want to do this; they'll just ... go elsewhere."

In addition to causing a brain drain, "it would be disastrous for patients," says Robert Lanza, vice president for medical and scientific development at Advanced Cell Technology (ACT) in Worcester, Mass. ACT startled the world last year by saying it had cloned a human embryo, though it did not survive long. "We are talking about the ability to generate replacement cells for damaged or dysfunctional cells – cell and tissue transplants," he adds. "If you'd had a patient advocate or two on the council, you might have seen an entirely different outcome."

Some religious and other groups oppose the research because it involves destruction of human embryos. They say there are noncontroversial alternatives to cloning that hold similar potential benefits.

Among council members – which include biologists, doctors, lawyers, political scientists, and bioethicists – 10 of 18 supported the moratorium, while seven favored going ahead with research, but under strict regulations.

Some observers suggest it might take years to put regulations in place without the pressure of a moratorium.

Still, in today's environment, Annas says, "transparency and accountability are words that have meaning not only in industry but in science as well."