Stem Cell Research Quandary Greets a Returning Congress

When Congress returns from its summer break this week, one of its biggest fights with President Bush is sure to turn on some very tiny things: 64 microscopic sets of human embryo cells, some of them in India, Sweden and Australia.

These are the only embryonic stem cells that Bush has said can be used in federally funded research into cures for disease. On Wednesday, the Senate holds the first of at least three hearings to investigate whether all 64 sets of cells are truly “robust,” “viable” and useful to researchers, as the Bush administration has said.

Some lawmakers suspect they are not. If enough of the cells turn out to be as fragile and untested as some of their owners have reported, then pressure is sure to grow for Congress to overturn the strict limitations on stem cell research that Bush imposed three weeks ago.

“I’ve seen those 64 stem cell lines evaporate,” said Sen. Arlen Specter (R-Pa.). “The 19 in Sweden are down to three. The seven in India may be zero. . . . If it turns out that the situation is not adequate for research, there’s going to be a lot of sentiment in Congress to legislate.”

Whether or not legislation gains momentum, the stem cell issue is likely to generate wide debate this fall in Congress--and beyond. Many lawmakers have already said they want to look not only at the number of cell lines available but also at patent rules and whether the Bush policy will cause a “brain drain” of U.S. researchers to countries with more liberal rules. Already, one prominent stem cell researcher, Roger Pedersen of UC San Francisco, is moving to England.

Among opponents of the research, there is little evidence of an effort in Congress to ban all funding for experiments using embryo cells. However, some state legislatures are taking up the issue.

In Ohio, lawmakers are considering a resolution that would ask Congress to bar all federal funding for embryonic stem cell research. In Nebraska, lawmakers this year voted to send some of the state’s tobacco settlement money to three universities but to bar them from using it for embryonic stem cell research.

The Senate hearings will be the first major opportunity for lawmakers to revisit the stem cell debate since Aug. 9, when Bush announced his policy.

Before then, well over 60 senators had asked Bush to support some kind of federal funding for the research. A clear majority of House members also favored funding, despite opposition from the top four House Republican leaders, including Speaker J. Dennis Hastert.

But Bush’s announcement, in a nationally televised address from his Texas ranch, dramatically altered the situation. Bush believes life begins at conception, and he said he would bar federal funding for any experiments that cause researchers to destroy human embryos.

But his speech also contained a big surprise: Stem cells had already been derived from more than 60 human embryos, he said--triple the number expected by most top researchers. Bush said the government would fund research using these cells because “the life-and-death decision has already been made” to destroy the embryos they came from.

Questions About Viability of Cells

Health and Human Services Secretary Tommy G. Thompson described the cell lines as diverse, robust and “viable for research,” and the National Institutes of Health later said that 64 cell lines--at 10 labs in five nations--would be eligible for federally funded experiments under the Bush policy.

Since then, however, some of the labs have said it is premature to say they have true stem cells on hand. Some have said they are months away from releasing any cells to other researchers.

And many of the labs used mouse cells or cow serum to promote the growth of the stem cells. Those stem cells might prove unsuitable for use as medical treatments because of federal rules designed to prevent the spread of animal diseases to people.

“The recent news reports that seem to question the number of cell lines available are certainly cause for concern,” said Sen. Tom Harkin (D-Iowa), who has scheduled two hearings on the subject before a health subcommittee of the Senate Appropriations Committee.

Harkin, who is chairman of the subcommittee, said he was withholding judgment on whether sufficient cell lines will be available to researchers under the Bush plan. “But if legislation is necessary to help us move forward--whether to provide clarification or ensure an adequate number of stem cells--we’ll pursue it.”

Opponents of the research are confident that, when all is done, the Bush plan will remain federal policy. Douglas Johnson of the National Right to Life Committee noted that the president has said twice that he would veto any attempt to broaden his policy.

It takes two-thirds of the House and Senate to overturn a veto. “I don’t think there’s any question that well over one-third of the House would sustain the president’s policy, no matter what specific facts emerge about the number of cell lines,” said Johnson, whose group wanted no federal funding but accepted the Bush plan.

Source for Specialized Tissues and Cells

Stem cells arise when an embryo is about 5 days old and consists of about 150 cells. Some of those cells--the stem cells--will go on to produce the billions of specialized tissues and cells of the body: heart, bone, nerve, blood. Stem cells also have the ability to replicate themselves endlessly without becoming any of those specialized cell types.

Researchers say it may be possible to use stem cells to create an endless supply of new tissues for diabetics, Parkinson’s patients and other people whose body parts are failing.

But it is a tricky feat to isolate and culture stem cells. The NIH, for example, said that Goteborg University in Sweden had 19 eligible cell lines, more than any other laboratory. But Peter Eriksson, a member of the university’s stem cell team, said the situation is complicated.

The university has taken cells from 19 embryos, but it has established stem cell lines from only seven of them. The other 12, Eriksson said, are in “early development,” with only “the first steps taken” to grow cell lines. While he was confident that all 12 will yield stem cell lines, Eriksson said more work and study was required.

Eriksson said that none of the seven established lines had been subjected to a key test in which the cells are injected into mice to assess their ability to become specialized cell types. But the lines showed other key hallmarks of true stem cells, he said, including the ability to replicate themselves.

Similarly, the NIH said CyThera Inc. of San Diego had nine eligible cell lines, the second most after Goteborg. But company officials said last week that none could truly be called stem cell lines yet and that they could wind up with more than or fewer than nine.

Reliance Life Sciences, one of two Indian labs on the NIH list, said that three of its seven cell lines were still in an “early stage” of development. It will take about six months before any of the cells can be shared with other researchers, the company said.

At UC San Francisco, officials said that one of their two cell lines had been closely studied but that researchers had just begun a close analysis of the second line.

Bill Pierce, a spokesman for the Department of Health and Human Services, said there was no attempt by the Bush administration to inflate the number of available cell lines. He noted that the NIH itself reported that some of the 64 lines are in early development and that there are no universal standards for what constitutes a true stem cell line.

“This was never a numbers-driven process.” Instead, he said, Bush decided how the research could proceed most ethically without regard to the number of cell lines that would qualify.

Sen. Edward M. Kennedy (D-Mass.) said that he intends to investigate the quality and availability of the cell lines at a hearing Wednesday before the Senate Health, Education, Labor and Pensions Committee, of which he is chairman. HHS Secretary Thompson is scheduled to testify.

For supporters of a broad research policy, Specter said, the first goal will be to block a measure approved annually since 1995 that bars federal funding for research in which embryos are destroyed. That measure, known as the Dickey amendment, has given anti-abortion groups ammunition to argue that the government may not fund any embryo cell research at all.

Revoking it would not require Bush to fund stem cell projects, but it would set the stage for other possible legislation. Specter said this might include broadening the number of cell sets that can be used in government-funded research or altering patent rules to ensure that researchers have access to privately owned cells.

He raised the possibility of taking certain ownership rights away from cell developers--in exchange for compensation--to make sure that the cells reach NIH-funded scientists.

In the House, Rep. Diana DeGette (D-Colo.) has asked a panel of the House Energy and Commerce Committee to schedule hearings. “If we find that the president’s restrictions hamper research, we will want legislation,” DeGette said.

“And I think we’ll have the votes,” she said. “The pressure is tremendous from constituents to continue with this research.”