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Woes for California's stem-cell experiment

Regulation and ethical battles swirl ahead as the state figures out how to spend its $3 billion initiative.

The debate over stem-cell research has been stirred again - this time by the unlikeliest of sources.

For months, state Sen. Deborah Ortiz has been the strongest political voice in favor of California's bid to earmark $3 billion for stem-cell research. From southern California to the halls of Washington, she took part in public forums and bandied words with the Bush administration to promote Proposition 71, the initiative that eventually passed last month.

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So when she recently said the plan was so flawed that it needed to be corrected by legislative decree, Senator Ortiz gave rise to a perplexing question: What has California gotten itself into?

Only half-joking, some scientists say California is set to become NIH West - a Pacific Coast counterweight to the federal National Institutes of Health. The concern is that no state has ever attempted a scientific venture of this magnitude and complexity, and some wonder if the state can handle it.

As other states from Wisconsin to New Jersey rush to counter California's massive investment by setting aside stem-cell money of their own, California is reprising a familiar role. As the biggest and the boldest, California will most clearly delineate the promises and perils of stem-cell science for the rest of the nation, showing the limits of federalism by its success or its failure.

"There isn't a precedent for doing biomedical research independent from the federal government," says Jeffrey Kahn, director of the Center for Bioethics at the University of Minnesota in Minneapolis. "[California is] starting from a different place than anyone else."

The challenges are immense. During the past 50 years, NIH has essentially invented the protocols that govern medical study in the United States - from peer review to ethical guidelines to patient protections. Not only does California have to come up with its own set of rules and regulations, but it also must create them for a scientific field that has never existed in the US.

When President Bush decided that the federal government should not fund the creation or study of new stem-cell lines, he largely squashed a new field of scientific study - as well as the ethical questions that came with it. Now, California must meet them both head on.

"They are going to have to make up from scratch things that don't exist," says Dr. Kahn.

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Even in a perfect scenario, the 29 board members of the program that will disburse some $300 million in grants each year would have a difficult job. They will have to choose which projects to fund, picking from among different areas of stem-cell research carried out by universities and biotechnology firms - all the while keeping an eye on the ethics of cloning human embryos. (While the proposition bans cloning humans for reproduction, it allows cloning so that embryos can be used to devise therapies.)

Those decisions lie ahead, however. The template for how to proceed has already generated concern. The template is the text of the ballot initiative itself, and it spreads across nine pages of the California voter's handbook. Only now, more than a month after the election, are analysts and politicians finally unraveling its intricacies, and not all like what they see.

Ortiz first pushed the idea of a stem-cell-research ballot measure, but she is troubled by some of the text. One section says that the legislature cannot amend the initiative for three years, and then only with a 70 percent supermajority. Board members who run the program aren't held to state requirements for disclosure of potential conflicts of interest. And protections for women who donate eggs - a potentially dangerous procedure - are left open.

Although Ortiz says she still supports the initiative, she is trying to pass legislation on these issues - despite the initiative's ban. She calls the measure the product of "an imperfect means of government."

Others are more critical: "This is not the sort of thing that should be done by initiative," says Marcy Darnovsky of the Center for Genetics and Society here. "How many voters went through all that fine print?"

Even supporters of Proposition 71 agree that the scientific process is often not served best by a ballot. But they suggest that the Bush administration left them with no choice. Nearly all agree that it would have been better for the federal government to pick up this work, mostly because NIH can fund the best research in the country - not just the best research in one state. In fact, some scientists suggest California might have difficulty finding enough good in-state ventures to spend $300 million a year wisely.

Yet now that the Bush administration has bowed out of ambitious stem-cell research, California's effort is an attempt to make the best of the situation. And it's a good place to start. "California is not just another state," says Robert Lanza of Advanced Cell Technology in Worcester, Mass. "It's like a country investing in scientific research."

Moreover, the processes for making good decisions are in place. The newly created California Institute for Regenerative Medicine might not be NIH, but the model is well known, and many of the people involved in California have been a part of it.

"There are no intrinsic difficulties that arise because it is a state and not the federal government," says Ira Black of the New Jersey's Stem Cell Institute in New Brunswick. "Through the peer-review mechanisms honed by NIH, there are clear guidelines in terms of proceeding."

What gives some ethicists pause, though, is the authority vested in the board members that run the California Institute of Regenerative Medicine. For instance, Prop. 71 was written in such a way that very few people other than the author Robert Klein were qualified to be nominated as chairman. Earlier this month, he was nominated.

Most observers say they still think the Institute will do its job well, and they note the importance of freeing science somewhat from the vagaries of public policy. But if California's experiment goes awry, either as a perceived money grab or as an ethical disaster, it is uncertain what anyone could do to stop it.

"It's not to say [the board] will not put [good rules] in place, but they don't have to," says Dr. Darnovsky. "This is important enough that there should not be a choice."