Can Congress beat the cloning clock?

As reproductive technology progresses, lawmakers have found themselves in a race against the clone.

Since the House of Representatives passed a bill banning all human cloning July 2001, Advanced Cell Technology, a Massachusetts company, has claimed to have cloned a human embryo, and Kentucky-based fertility specialist Panayiotis Zavos has told a Boston newspaper he is ready to begin attempts to clone a human at an undisclosed location. Until Congress decides how to regulate cloning technology, what laws apply to cloning and who is to enforce them remain unclear.

The Human Cloning Prohibition Act, which passed the House by a vote of 265-12, mandates civil and criminal penalties for those who participate in, perform, or attempt to perform human cloning. It also prohibits shipping or receiving embryos produced by human cloning.

But the legislative agenda has changed significantly since then. While Congress has been focused on the war on terrorism, anthrax scares, the Enron scandal, and campaign finance reform, said George Annas, chair of the Health Law Department at the Boston University School of Public Health, the cloning issue has held its own.

"It's a matter for the Senate now," Annas said. "It's really up for grabs."

"I think it's going to be a pretty close call in the Senate," said University of Wisconsin law professor Robin Alta Charo, adding that the Senate might come to a stalemate over provisions related to embryo research.

The major debate centers on whether to ban all human cloning, as the House bill does, or to allow human embryos to be cloned for research or medical use (therapeutic cloning). Cloned human embryos are considered an ideal source of stem cells, which could provide the key to eradicating serious diseases.

A general consensus has emerged that reproductive human cloning, where the cells from a single parent would be cloned and the resulting embryo implanted in a woman's uterus, should be banned. A Senate bill sponsored by Sam Brownback (R-Kan.) mirrors the broader ban of the House bill. Two other pending Senate bills, sponsored by Tom Harkin (D-Iowa) and Dianne Feinstein (D-Cal.), would allow cloned human embryos to be used for research but would prohibit reproductive cloning. The prospect of allowing human embryos to be created and destroyed in a laboratory has prompted opposition from antiabortion forces, adding another facet to the debate.

In a television appearance at the end of February, Brownback said neither his nor Feinstein's bills had, at that point, enough votes to pass.

The Senate's failure to move the issue to the floor frustrates sponsors of the bill passed by the House last session.

"I predicted during our hearings that some lab would clone a human embryo by fall, and Advanced Cell Technology has fulfilled that prophecy," said Rep. Bart Stupak (D-Mich.), a sponsor of the House bill. "Not only have they taken this step, but they have published, for general consumption, the blueprint on how other laboratories can create human embryos for research and reproductive purposes." Stupak reaffirmed the need for the Senate to address legislation immediately.

ACT did not respond to requests for comment. In a press release issued in November 2001, the company stressed the therapeutic benefits of cloning. "Human therapeutic cloning could be used for a host of age-related diseases," said chief executive officer Michael West. In its statement, the company denied that it wanted to create cloned human beings, saying its goal is to create young cells, identical to a patient's, for treating disease.

The company has since claimed to have created working kidneys from cloned cow embryos. If the technology can be developed in humans, cloned organs, which would be genetically identical to a recipient's cells, could eventually solve one of the major problems of organ transplants, the host's rejection of the transplanted organ.

Although there may be relative unanimity on banning reproductive cloning, the question of whether to prohibit therapeutic cloning is more divisive. After ACT announced its progress in cloning a human embryo in November, Sen. Edward Kennedy (D-Mass.), a member of the Public Health and Safety Subcommittee, issued a statement urging consideration of the technology's promise.

"I strongly oppose the use of cloning technology to reproduce a human being," Kennedy said in his statement. "But we must also protect essential areas of medical research involving cloning technology, including stem-cell research."

The National Academy of Sciences, in a report published in January, recommended a ban on human reproductive cloning, calling it "dangerous and likely to fail." The group recognized the potential of therapeutic cloning in medical research: "The scientific and medical considerations that justify a ban on human reproductive cloning at this time are not applicable to nuclear transplantation to produce stem cells," the academy report said. "Because of its considerable potential for developing new medical therapies for life-threatening diseases and advancing fundamental knowledge, the panel supports [a recommendation] that biomedical research using nuclear transplantation to produce stem cells be permitted. A broad national dialogue on the societal, religious, and ethical issues is encouraged on this matter."

A discussion of legal issues surrounding cloning is already well under way.

The FDA has claimed jurisdiction to regulate cloning, but some say that claim is questionable. The House of Representatives acknowledged the questions regarding FDA jurisdiction in its report on the bill it passed. "Currently, no clear regulations exist in the United States that would prevent a private group from attempting to clone a human being," the report said. "The Food and Drug Administration has announced that it has the authority to regulate human cloning, but that authority has been questioned by many experts and remains unclear today."

"It's not a new drug," said Arthur Caplan of the University of Pennsylvania's Bioethics Center.

But Kathryn Zoon, director of the FDA's Center for Biologics Evaluation and Research, told Congress in March 2001 that the agency "has the authority to regulate medical products, including biological products, drugs, and devices."

"The use of cloning technology to clone a human being would be subject to both the biologics provisions of the Public Health Service Act and the drug and device provisions of the federal Food, Drug and Cosmetic Act," Zoon said. "Because of the profound moral, ethical, and scientific issues, the administration is unequivocally opposed to the cloning of human beings." The Bush administration recently appointed a committee on bioethics to advise the White House on the issue.

The FDA has sent letters to researchers reported to be experimenting with cloning, although the agency refused to identify the recipients. In the letters, the agency asserted that clinical research to clone a human being is subject to FDA regulation. Before beginning such research, the letter said, the sponsors must submit an investigational new drug application (IND) and obtain authorization from an institutional review board.

"Since the FDA believes there are major unresolved safety questions pertaining to the use of cloning technology to clone a human being, until those questions are appropriately addressed in an IND, FDA would not permit any such investigation to proceed," the letter said.

The debate has taken on an international scope with the United Nations conducting hearings in late February on a resolution to ban human cloning.

As of January, at least eight states had passed laws related to human cloning. Some, such as that in Missouri, limit the use of state funds for human cloning research. Others, such as in California and Michigan, prohibit human cloning.

Because of their powers to regulate medical licenses, state legislatures, if they choose, could play a significant role in the regulation of human cloning, said the University of Wisconsin's Charo. State medical malpractice rules and negligence standards could also be factors. For example, states could declare that reproductive cloning is a highly dangerous activity and attach strict liability standards.

"Adopting a strict liability standard would mean that if a medical professional attempted reproductive cloning, one would not need to prove negligence," Charo said.

Although debate is certain, cloning success is not. It took 71 eggs from 7 volunteers to produce ACT's 3 embryos. The successful embryos stopped growing after dividing into 4 or 6 cells. Studies involving cloned animals have shown that they develop health problems and possibly reduced life spans.

"It's proving so hard to clone animals, I think people are starting to see that human cloning may simply be impossible," Caplan said.