The Stem-Cell Also-Ran: America

By John Carey It's a great time to be a stem-cell researcher -- unless you're working in most U.S. laboratories. In quick succession, foreign labs have announced a series of major breakthroughs, developments that move scientists a step closer to cures for a range of illnesses. On May 20, British researchers revealed that they had cloned a human embryo. The same day, a Korean team announced success in creating stem cells from embryos cloned from people with diseases. Such cells could then theoretically be used as treatments for those people. And earlier this year, Japanese researchers reported that they had used stem cells to cure Parkinson's-like disease in monkeys.

These overseas triumphs are a reminder that restrictions on federal funding for stem-cell research in the U.S., as well as many state and federal threats to ban much of the research, are hindering the pace of research in America. As part of an ongoing lobbying effort, 37 university presidents and chancellors sent Congress a letter on May 23, arguing that progress in foreign labs is "an indication that U.S. scientists are being hobbled in their pursuit of cures and therapies using this promising research."

A day later, the House of Representatives passed a bill that would relax the limits on research. But with President George W. Bush threatening to veto the bill if it clears Congress, it looks like U.S. researchers will have to resign themselves to "playing catch-up," says Charles Jennings, executive director of the Harvard Stem Cell Institute, which has raised $30 million in private funding.

CONSTANT THREAT. One advantage foreign scientists have is higher levels of government funding. Korea alone is estimated to be spending more than $100 million a year on embryonic stem-cell work, compared to a paltry $24 million last year from the National Institutes of Health. In addition, several countries, such as Korea and Britain, explicitly allow the creation of human embryos as a source of stem cells. In the U.S., there's a constant threat that such an approach could be banned.

As a result, researchers fear the U.S. is at a serious competitive disadvantage. The effects won't be seen immediately. It will take years for researchers to learn how to transform stem cells into new heart muscle, neurons, pancreatic cells, or other key tissues consistently enough to meet Food & Drug Administration requirements for the safety of new treatments.

But the research will have more shorter-term applications, such as creating cells that the pharmaceutical industry can use to test new drugs. And already, researchers are staking claims to valuable intellectual property. By falling behind, experts say, the U.S. could lose out on the eventual commercial applications to companies in Korea, Singapore, India, and other countries that are rushing ahead with the science.

"MODEL-T" CELLS. That would be a stunning reversal, since the field was pioneered in the U.S. American researchers were the first to create long-lived cultures of stem cells, called "stem-cell lines" in 1998, and the scientific community immediately saw vast potential. Stem cells are undifferentiated progenitors -- able to become many different parts of the body. Researchers believe, for example, it should be possible to transform stem cells into the insulin-producing cells that are lost in diabetes, or the dopamine-making neurons lost in Parkinson's Disease, thus curing those illnesses.

But in August, 2001, Bush, citing an aversion to destroying human embryos in the process of extracting stem cells, restricted federally funded research to only existing stem-cells lines. That had a chilling effect on research in the U.S. Those cell lines created before August, 2001-- of which only 22 are useful -- are "the model-T versions," explains Dr. Robert Goldstein, chief scientific officer at the Juvenile Diabetes Research Foundation, which now gives two-thirds of its grant money for embryonic stem cell research to foreign scientists.

The bill passed by the House would allow scientists to create more cell lines from thousands of embryos now slated for destruction at in vitro fertilization clinics. While that could bring several hundred more stem-cell lines into play, the bill "is like getting a foot in the door and trying to open it a little, when other countries are building huge gates," says cloning expert Jose Cibelli, professor of animal biotechnology at Michigan State University.

TALENT DRIVE. And Bush vows to veto the bill anyway. "I made it very clear to the Congress that the use of federal money, taxpayers' money, to promote science which destroys life in order to save life is -- I'm against that," Bush reminded reporters just last week.

The outlook isn't totally bleak. The federal government is spending several hundred million dollars on work with stem cells in mice and with adult stem cells. And some states and private funders are stepping into the void left by the federal government on human embryonic stem cells. Last November, California voted to spend $3 billion over 10 years. The Harvard Stem Cell Institute has raised $30 million from foundations and private donors, and is creating its own stem-cell lines. The Starr Foundation is giving $50 million to three New York City research centers over three years for stem-cell work.

The support is enabling U.S. scientists to continue to make significant strides. At Johns Hopkins stem-cell pioneer John Gearhart is successfully creating heart cells that could be used to treat heart disease. "You cannot underestimate the talent present in this country," says Gearhart. "This is the group that has led the world."

These efforts will keep the U.S. in the game -- but not in the unchallenged lead. "We're really in the Dark Ages," charges Cibelli. "We're failing at the core -- at providing the federal money that would lead to new biotechnology and new companies able to take this to patients." Unless the Administration changes its stance, many breakthroughs will continue to come from outside the U.S. Carey is a senior writer in BusinessWeek's Washington bureau

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