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

Article excerpt

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.

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.

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. …