By Rick Weiss
Washington Post Staff Writer
Friday, November 13, 1998; Page A01

Scientists, ethicists and federal regulators scrambled yesterday to sort out the many controversial issues raised by a small biotechnology company's announcement that it had used cloning techniques to create an embryo out of human and cow cells.

The work, conducted in 1995 and 1996 at Advanced Cell Technology of Worcester, Mass., but not made public until yesterday, was part of an effort to make medically useful tissues but also appears to be the closest that anyone has come to cloning a human being.

Among the many questions raised by the revelation was whether the research broke a ban on the use of federal funds for embryo research; whether it bypassed Food and Drug Administration rules on research; and how the work passed muster with the ethics review board at the University of Massachusetts in Amherst, where the company-supported work was done.

Those and other uncertainties led several experts yesterday to call upon Congress and the White House to clarify the regulatory framework within which human embryo research and other high-tech human studies are conducted.

"We will be contacting the White House today to ask that the president have the National Bioethics Advisory Commission examine these issues," said Carl Feldbaum, president of the Biotechnology Industry Association, who said he was excited by the findings but was concerned by the lack of regulatory clarity.

The Worcester company produced one cloned human embryo – perhaps the first ever made – and performed the unprecedented cross-species hybridization of a human cell and a cow egg.

Michael West, president of the company, said in an interview yesterday that although the technique was very similar to that used to clone Dolly the sheep, he had no intention of cloning adult humans. Rather, the project's goal was to grow replacement cells and tissues for transplantion into people with diseases.

West said he had recently reopened the files on the dormant experiment and concluded that it was largely successful. He was publicizing the findings, he said, because the company had the moral responsibility to get feedback from the public before going any further.

Several critics, however, said they suspected the company had made a business decision to ride a new wave of interest in cultured embryonic cells, spurred by recent promising reports published in scientific journals. In contrast to those recent studies, West's company has not submitted its findings for review and publication in a research journal. Instead it released its findings to the New York Times, which ran a report about it yesterday. That suggested to some that the company was primarily trying to position itself to make an an intellectual property claim on cell transplant technology.

"What do they have? They've got no publication, they've got nothing," said George Annas, a professor of health law at Boston University. "All they have is the opportunity to tag along with the other stem cells in the news. They're saying, 'Let's cash in.'‚"

West said the company's team had fused a human skin cell to a cow's egg whose genes had been removed. The fluids that remained in the gutted cow egg caused the genes in the human cell to revert to their primordial state, as though they were back in a developing human embryo. The fused cell divided several times, and microscopic examination indicated that some of the resulting cells resembled stem cells, which scientists hope to harness for medical purposes and for which the company has submitted a patent claim.

Other scientists disputed West's conclusions, however, saying the Worcester team never did the basic tests used to see if cells are really stem cells. West confirmed those tests were never done.

Roger A. Pedersen, a stem cell researcher at the University of California, San Francisco, said the company's claim of having isolated stem cells shocked him. "One must be very circumspect about such a fanciful notion without good data to support it," he said.

Moreover, Pedersen and others said, experiments in other species have shown that hybrid embryos made from divergent species grow poorly and suffer many defects because of an incompatibility between the newly transferred genes (in this case human) and so-called mitochondrial genes that are left behind in the fluid of the gutted egg.

"There's a carefully choreographed dance between nuclear DNA and mitochondrial DNA," Pedersen said, saying he doubted the Massachusetts team's cells would have much medical value.

John Gearhart, who last week published a scientifically reviewed report showing he had isolated human embryonic stem cells from fetuses, agreed, saying the new report reminded him of the much ballyhooed and ultimately disproved claims of "cold fusion" earlier in this decade.

Experts also questioned the legal and ethical basis of the work. Congress has banned federal funding for human embryo research, and Gearhart, Pedersen and others work in labs from which federally purchased equipment has been scrupulously excluded.

West said the company's embryo work was done using only corporate funds, but officials at the University of Massachusetts said they were unaware that any of the labs in the building where the work was done had been specially cleared of all equipment purchased with federal grant money. "We don't have an NIH room and an NSF room and so on," said Michael Weinberg, special assistant to the vice chancellor for research. "Faculty members get funded and they go from room to room."

The role of the FDA also remained unclear yesterday. Acting FDA Commissioner Michael Friedman said that if the work was basic research then the company was under no obligation to get approval from the agency, but if it was done with the intention of developing a cellular therapy for use in humans then the company should have filed for an Investigational New Drug application. With only a newspaper report to describe what the team did, he said, it remained unclear to him which category the work belonged in.

Others questioned how the university's institutional review board could approve the species-mixing research. Weinberg, who heads that committee, said the group only considered whether it posed a risk to the researcher who donated his skin cells. But other experts said such committees are clearly required by federal law to consider the full range of scientific and ethical issues raised by proposed research. They said the committee's quick approval gives credence to a recent federal report that called for a major overhaul of the nation's local research review system.

"What this whole business shows is that we are in a regulatory nightmare," said Glenn McGee, a professor of bioethics at the University of Pennsylvania. "It's going to be impossible to state whether these things are really human, let alone how to protect them."