Copyright 2001 Globe Newspaper Company  
The Boston Globe
April 4, 2001, Wednesday ,THIRD EDITION
SECTION: BUSINESS; Pg. D4

LENGTH: 1078 words

HEADLINE: BIOTECHNOLOGY;
DEBATE FLARES OVER CLONING OF HUMANS COMPLEX QUESTIONS ARISE ON REGULATION AMID ANNOUNCEMENTS OF PLANNED EFFORTS

BYLINE: By Anthony Shadid, Globe Staff

BODY:
WASHINGTON - Researchers envisioning the Brave New World of human cloning may face an even bigger challenge than the uncertain science: a complicated array of state law, legislators' intent, federal mandate, and regulatory confusion over a matter as emotional as it is medical.

Currently, there is no US law expressly banning human cloning, though several states bar it and the Food and Drug Administration prohibits the practice on safety grounds. But recent declarations that a cloned human could be coming soon have reignited a debate in Washington over who has the authority to determine what researchers can and cannot do.

   From biotechnology to stem cell research, that debate is becoming more familiar as lawmakers and regulators increasingly are asked to arbitrate the moral, ethical, and political merits of cutting-edge research that remains a mystery to all but a handful of scientists. The trade offs are immense: averting a nightmarish medical mishap or standing in the way of the next breakthrough in combating cancer or Alzheimer's disease.

Cloning "captures the public's imagination, and not in a good way," said Dr. George Annas, chairman of health law at Boston University's School of Public Health. "And you have to get past that if you want to regulate it."

More than two dozen countries ban human cloning, as do a handful of US states - California and Rhode Island, among them. Legislation forbidding it has been introduced in Massachusetts. Former President Clinton barred federal funding for research into creating a child through cloning, and the scientific community, almost in its entirety, stands against the practice.

Yet the opposition to cloning is often shaded. Even opponents of human cloning fear legislation could be so sweeping as to stanch research they believe has potential for a host of therapies. Lawmakers, meanwhile, have suggested they have to make sure no such experiment ever occurs.

Calls for legislation have mounted with the announcement by two groups this year of their intent to clone a human. One group is led by Italian reproductive specialist Dr. Severino Antinori and a colleague in Kentucky, Dr. Panos Zavos. The other group is Clonaid, affiliated with the Raelian movement, which believes humans were created by advanced extraterrestrials who cloned life forms.

Scientists have already cloned mice, cows, goats, pigs, sheep and a wild ox, but the success rate is low. The first sheep cloned required 276 attempts.

"Other institutions can issue reports, hold meetings, or announce voluntary policies," said Representative W.J. "Billy" Tauzin, a Louisiana Republican who chairs the powerful House Energy and Commerce Committee. But only Congress, he added during hearings last week, "can write the laws that could regulate or even ban human cloning."

As it stands, the FDA has taken the lead in attempting to regulate human cloning. It draws its authority from two laws - the Public Health Service Act and the Food, Drug and Cosmetic Act - that give it jurisdiction over biological products, drugs, and devices. It interprets those laws to cover human cloning both as a biological product and a drug, and insists that it has to give permission to scientists before any research can begin.

Until safety concerns are resolved, the FDA has said it won't give that permission. Last month it sent letters to both groups claiming to be working on human cloning, warning them that it would not permit their research.

Other agencies, including the National Institutes of Health, the government's leading research institution, have deferred to the FDA - to the chagrin of some lawmakers. "I find that lacking, in a sense, that the nation's premier health organization is not here," Representative Peter Deutsch, a Florida Democrat, said of the NIH's absence at the hearings.

Lawmakers have questioned, too, the FDA's authority over cloning. Tauzin said the agency's interpretation was akin to fitting a "square peg in a round hole" and he doubted whether a "single reed of federal regulation" was enough protection against experiments that might one day create a baby.

Critics also have asked whether the FDA's authority would extend to morals and ethics. If the experiment was proven safe, for instance, would the agency then have to approve it? Others doubt that the agency's authority would hold up under a court challenge.

"Is this a sufficient safeguard?" James Greenwood, a Pennsylvania Republican who chairs the subcommittee that organized the hearings, asked rhetorically.

Both Tauzin and Greenwood have promised to introduce legislation banning cloning, and the White House has signaled that President Bush would go along.

But some scientists, while supporting a ban on human cloning, fear that a future law would prohibit "therapeutic cloning," in which embryos would be copied to produce cells, tissue or even organs that could be transplanted without immune rejection.

"This is our concern. There may be a blacklash to the legitimate applications to the technology," said Dr. Robert Lanza, vice president of medical and scientific development at Worcester-based Advanced Cell Technology, which has cloned 40 cows on its premises. "Millions and millions of people out there could benefit from this technology."

Britain, for one, has banned creating a child through cloning. But earlier this year, Parliament sanctioned research into therapeutic cloning.

Advocates in the United States fear that that distinction won't be made if legislation is eventually passed. They say deliberations will likely be overwhelmed by the deep-ending divisions over stem cell research, casting the debate into another variation of the struggle over abortion rights.

They point out as well that many scientific and medical groups have already joined in a private moratorium on human cloning that dates to 1998, making the need for federal legislation less pressing.

"Going into the legislative arena on an issue as complex as the distinctions between therapeutic and reproductive cloning serves to confuse a lot of legislators and staff and is a temptation to others to treat the bill as a Christmas tree for provisions on stem cell research, abortion, what have you," said Carl B. Feldbaum, president of the Biotechnology Industry Organization, a trade group in Washington. "They're not real deep when it comes to this technology."

Anthony Shadid can be reached by e-mail at ashadid@globe.com.

LOAD-DATE: April 4, 2001