Recent Rulestymies Testson Stem Cells

By Rick Weiss

WASHINGTON, D.C. <\ With the active encouragement of the Bush administration, U.S. scientists in the past year have developed several methods for creating embryonic stem cells without having to destroy human embryos.

But some who now wish to test their alternatively derived cells have found themselves stymied by an unexpected barrier: President Bush’s stem cell policy.

Continued limits on federal funding of embryonic stem cell research, spelled out in President Bush’s June 20 executive order, ban funding for new approaches that do not destroy embryos if there is even a chance that those embryos might face more than minimal harm.

The 2001 policy says that federal funds may not be used to study embryonic stem cells created after Aug. 9 of that year. It is based on the assumption that the only way to make the cells is by destroying human embryos – a truism in 2001 but not any longer.

Grant application refused

As a result, the National Institutes of Health recently refused to consider a grant application for what would have been the first federal study to compare several of the new, less politically contentious stem cell lines.

“This is not the way to make good health policy,” said Robert Lanza, the frustrated vice president for research and scientific development at Advanced Cell Technology in Worcester, Mass. Lanza submitted the study proposal with stem cell experts from several major research labs.

Upcoming changes in the NIH’s stem cell funding rules may eventually help resolve that problem. But agency officials and others say the policy tangle is more complicated than that. Although Lanza’s technique and other new approaches do not destroy embryos, they may run afoul of a long-standing congressional ban on studies that “harm” human embryos.

The question of harm

That vague language raises the perplexing question of how one would know whether an embryo had been harmed.

At the center of the debate is a new technique, pioneered by ACT, that obtains stem cells from human embryos while leaving the embryos functionally intact. A single cell, called a blastomere, is removed from an eight-cell human embryo, then coaxed to multiply into a colony of stem cells in a dish.

Fertility doctors have been performing these blastomere biopsies for years to identify embryos that harbor genetic defects. Since a single cell is representative of the entire embryo, doctors transfer to a mother-to-be’s womb only those embryos whose plucked cells pass genetic muster.

In unpublished research, ACT has made several colonies of stem cells this way, Lanza said.

The question is whether stem cells made this way are as versatile as those harvested from destroyed embryos.

To find out, Lanza and a team of others compared stem cells made by various means. The group submitted a proposal to the NIH in February, then waited. And waited.

Then, in a series of e-mails, the agency informed Lanza and the other team the application was being sidelined indefinitely for “administrative review.”

Story Landis, who heads the NIH’s stem cell task force, said the main issue is Bush’s Aug. 9, 2001, stem cell policy. It called upon the NIH to make a list of all embryonic stem cell lines known as of that date and blocked funding for research on any cells but those.

A research Catch-22?

But currently, there are no cell lines derived from single blastomeres listed on the stem cell registry, Landis said.

Sean Tipton, president of the Coalition for the Advancement of Medical Research, a stem cell research advocacy group, said the policy amounts to a Catch-22.

“On the one hand, they’re saying, Find this out,’” Tipton said, referring to the Bush administration’s repeated call for scientists to find ways to make and study stem cells without destroying embryos. “On the other hand, they’re saying, You’re not allowed to do the research to answer these questions.’”

Agency insiders, however, said the NIH is likely to convene workshops and fund animal tests to study the degree of harm various procedures pose to embryos – a meticulous approach that strengthens suspicions among research proponents that real stem cell policy changes are unlikely while Bush is in office.

“I think they’re trying to ride the clock out,” Lanza said.

(c) 2007 Pantagraph. Provided by ProQuest Information and Learning. All rights Reserved.