By Randall Osborne


Last summer, Origen Therapeutics Inc. pulled down a $100,000 Phase I Small Business Innovation Research grant from the National Institutes of Health (NIH) to experiment with embryonic stem cells.

In chickens.

Given the scientific excitement over human embryonic stem cells which seem to have the potential for research that could lucratively alleviate a vast range of diseases Origen's efforts with fowl seemed an odd thing.

Burlingame, Calif.-based Origen, though, said it might be able to bring about "the large-scale replication of desirable avian lines" with its technology platform, "as well as the genetic engineering of poultry."

And now, given the fresh turmoil due to erupt over human stem cells, the privately held firm's decision to deal with barnyard creatures doesn't seem so bird-brained after all.

The March deadline nears for scientists to seek funding for embryonic-stem cell research under NIH guidelines, and the biotechnology industry is gearing up for what may be the first big skirmish with the new president.

Or maybe not.

"Leave those embryos alone," Bush seemed to say, during his campaign. If that's what he was saying, then many religious groups were with him on the subject. So is the Pope, for that matter and, on the scientific side, former U.S. Surgeon General Everett Koop is among the backers of the Washington, D.C.-based Center for Bioethics and Human Dignity, which wants a ban on any research that "necessitates the destruction of human embryos."

The group wants the feds to "provide federal funding for the development of alternative treatments which do not require the destruction of human embryonic life," it says in a position statement.

Such money should not go toward any such research that "necessitates the destruction of human embryos," the center says.

"If anything is to be gained from the cruel atrocities committed against human beings in the last century and a half, it is the lesson that the utilitarian devaluation of one group of human beings for the alleged benefit of others is a price we simply cannot afford to pay," it concluded.

Bush pleased anti-abortion crusaders during his campaign by vowing to quash federal backing for stem-cell work. The move, if Bush follows through, will slow academic efforts, could depress private collaborators' investigations, and surely would encourage a more conservative view of the research by the general public.

Michael Werner, director of federal government relations and bioethics counsel for the Biotechnology Industry Organization (BIO) in Washington, said a report last week indicated Bush has asked the Department of Health and Human Services (DHHS), of which the NIH is a part, to look further into the matter.

"Am I optimistic?" Werner told BioWorld Financial Watch. "We're hopeful the administration will study this carefully, and recognize the existing policy is a carefully balanced approach. Some of the statements in the early days were troubling, but what he's going to do now, I don't know."

As things stand, the NIH won't let scientists take federal money for work on a human embryo, nor for embryo cloning, but they can experiment on stem cells if privately funded entities provide them.

Stem cells are harvested about a week after an egg is fertilized, and the debate over their use in research has begun to echo the abortion debate itself.

The law has seesawed in the past decade or so. A federal amendment in 1996 nixed funding for research in which a human embryo is "destroyed, discarded or knowingly subjected to risk of injury or death."

Under Clinton's reign, officials decided the government will pay for research on stem cells that came from privately backed concerns. The anti-abortion sector argues that stem cells from adults, such as those from the brain, could be used instead to which researchers counter that no one knows if those cells are as malleable and important as embryonic stem cells.

So it goes. The shouting about what public money should pay for, and what it shouldn't, was expected to escalate during the January confirmation hearings for Wisconsin Gov. Tommy Thompson, Bush's pick to head the DHHS.

It didn't happen.

"He wasn't even asked a question about it," Werner said.

The two landmark 1998 projects that first isolated what are often known as pluripotent stem cells (PSCs), because they are capable of developing into many types of specialized cells, were conducted at Johns Hopkins University in Baltimore and at the University of Wisconsin in Madison.

Once the possibilities in stem cell research became clear, scientists clamored for public funding, so advances could move more quickly. Those possibilities apparently are broad, especially if the reasons for stem cells' differentiating into specific types of other cells can be figured out.

Last fall, researchers at Howard Hughes Medical Institute and Hebrew University reported that, when they exposed stem cells to eight growth factors, the latter caused the stem cells to divide into three types, which then split into various organ and tissue cell types.

It was even more involved than that. Some growth factors inhibited certain of the three initial lineages, and allowed others. Search efforts such as those by Human Genome Sciences Inc. are designed to find signaling factors, the likes of which make stem cells do what they do in specific ways.

The NIH came up with its public funding guidelines.

"Studies utilizing pluripotent stem cells derived from early human embryos may be conducted using NIH funds only if the cells were derived from early human embryos that were created for the purposes of infertility treatment," the guidelines say, "and were in excess of clinical need of the individuals seeking such treatment." Any petition for NIH funds must include a signed assurance that the cells were derived from leftover frozen embryos created as part of fertility treatment.

Another potential source of stem cells is from fetal tissue, and it's here that the anti-abortion groups found an argument, Werner said. They spoke of a black market, and "incentives" for abortions.

"Opponents of stem cell research tried to block NIH funding," he said. "They failed, but that was the context."

Werner said BIO believes the current rules are fair. After the issue failed to arise during the Thompson hearings, the time line for debates over changes is unclear.

"I don't think it's a non-issue, but the only discussion that's come out has been White House response to press queries," he said. "The administration is kicking it around."

For the time being, stem cell research forges ahead and apparently not everyone's convinced it's a bad idea. Johns Hopkins' stem cell program chalked up an anonymous $58 million gift last week.

"If there's a confirmation hearing for an NIH director, [the funding issue] might come up then, or it might come up in the appropriations process," Werner said. "That's when it usually does. We're in a little bit of a holding pattern now." *