Federal funding for embryonic stem cell studies gets a boost

Washington --The fate of federal legislation that ultimately would expand the number of embryonic stem cell lines qualifying for federally funded research grants remains unclear, but a recent floor statement by Senate majority leader Bill Frist, MD (R, Tenn.), gave supporters new hope that a bill can pass Congress this year.

On the last day before lawmakers left for an August recess, Dr. Frist, said that, despite some reservations, he would support a House-passed bill that would overturn an August 2001 executive policy that effectively limits federal funding to research on 22 approved lines of embryonic stem cells. He also said he would hold a vote during the current session.

"While human embryonic stem cell research is still at a very early stage, the limitations put in place in 2001 will, over time, slow our ability to bring potential new treatments for certain diseases. Therefore, I believe the president's policy should be modified," Dr. Frist said.

He said the federal government should fund more stem cell research, including the study of adult and embryonic stem cells and of new ways to derive the cells without destroying the blastocyst.

The speech drew praise from the measure's supporters, including Sen. Arlen Specter (R, Pa.), who considered adding the bill's language to the Health, Education, Labor and Pension appropriations to ensure a Senate vote.

The measure is expected to pass the Senate. But just passing the bill won't be enough to guarantee that federal funds would be available for embryonic stem cell research.

Two-thirds of the Senate would need to vote for the bill to overcome an expected presidential veto. The same is true in the House. The House passed the bill 238-194, shy of a two-thirds majority. Consequently, another House vote would be needed.

Supporters said they believed they ultimately could win support of two-thirds of Congress, but experts expect future votes to be close to that margin.

With the reality of increased federal funding for embryonic stem cell research unclear, a growing number of states are taking it upon themselves to try to pay for scientific studies.

In July -- before Dr. Frist's announcement -- Connecticut lawmakers approved millions of dollars in new state funding to assist researchers who want to study embryonic stem cell lines that don't qualify for money under the Bush administration's funding restrictions. Also in July, Illinois Gov. Rod Blagojevich announced an executive order dedicating state dollars to embryonic stem cell research.

Those states join California, New Jersey and Ohio in approving money for studies on stem cell lines that don't qualify for federal dollars.

Although states are eager to move forward with efforts to fund embryonic stem cell research, some experts are concerned that patient protections are being overlooked. And the road from approving state dollars to seeing the research come to fruition isn't necessarily smooth.

Ohio has been funding adult stem cell research at the Center for Stem Cell and Regenerative Medicine since 2003. New Jersey and California are both in the process of setting up similar institutions to conduct state-funded stem cell research.

But California is facing difficulties in implementing a policy voters approved last year. The California Institute for Regenerative Medicine, the entity established to distribute $3 billion in research funds, has been stymied by lawsuits filed by groups opposing the studies.

"These lawsuits seek to subvert the will of the people," said Larry Goldstein, PhD, professor of cellular and molecular medicine at the University of California, San Diego, School of Medicine. "If it's going to take 10 years to do this research, and it is pushed back five years because of delays, then it will just take 15 years to get the benefits."

Still, he and other experts believe that the California funding effort eventually will move forward.

"This is a really aggressive plan, so it may take a few months longer to work out the kinks," said Kevin Wilson, public policy director for the American Society for Cell Biology, an organization of researchers that promotes the field of cell biology.

But there are a lot of kinks to be worked out, said Jesse Reynolds, project director for biotechnology accountability at the Center for Genetics and Society, a nonprofit think tank in Oakland, Calif. The group opposed the California referendum.

Although the center supports government funding of embryonic stem cell research on principle, the California law fails to provide adequate oversight, public transparency and patient protections, Reynolds said.

"The state governance generally does not have the expertise or the infrastructure to embark on this kind of research effort," he said.

Reynolds said states also have overlooked potential ethical consequences of funding such research. For example, the law doesn't take into account that one of the most promising aspects of embryonic stem cell research is therapeutic cloning, which involves somatic cell nuclear transfer using unfertilized human eggs.

While researchers are barred from offering financial incentives to women to procure the embryos from which the stem cells are derived, the law doesn't include such protections for unfertilized eggs. Women may be encouraged to sell their eggs despite the health risks of the procedure for harvesting them, Reynolds said.

He also fears that state legislatures could be neglecting basic patient protections for fear of losing private biotech investment to other states.

"It is a little bit troubling that all these states see this as the next big thing for their economies," Reynolds said.

Those types of concerns highlight why it would be better to fund this type of research under the umbrella of National Institutes of Health, said the ASCB's Wilson. "Not only does it allow for scientists across the country, but NIH provides time-tested patient protections and protocols that simply aren't present in state efforts," he said.

Unfortunately, the federal funding now comes with too many strings attached, Dr. Goldstein said.

NIH funding for stem cell research amounted to more than $550 million last year, with $113.6 million of that going to study embryonic stem cells, an NIH spokesman said.

But many researchers find it difficult, if not impossible, to conduct embryonic stem cell research within the restrictions Bush set. Under that policy, federal dollars are available only for studying embryonic stem cells derived from cell lines established as of August 2001.

"As a scientist, you want to be able to use the best materials available," Dr. Goldstein said. "There are now 10 times as many unapproved stem cell lines as approved cell lines."