October 08, 2006

Strategic Plan for California's World Domination in Stem Cell Research

The staff of the California Institute for Reproductive Medicine (CIRM), which is the agency managing the state’s stem cell initiative, has just released a draft strategic plan [download incredibly big PDF here] which outlines its goals and spending priorities for the next ten years. While there’s a lot here of interest to both scientists and bioethicists, on first reading two things stand out:

1—Lowering expectations—Like several other recent public commentaries by stem cell scientific types in the New York Times and the New England Journal of Medicine, the CIRM draft seems to downplay the possibility of major stem cell therapeutic breakthroughs over its ten year time horizon. The draft argues that it is unlikely that CIRM-funded research will be able to “fully develop stem cell therapies for routine clinical use” over this time period, but plans to advance therapies for several diseases to the stage of early clinical trials and have others in the pipeline. The plan’s goals call for “clinical proof” of restoring function in at least one disease, with therapies for 2-4 additional diseases in Phase I or II trials.

This assessment is less optimistic than some of the rhetoric heard during the recent debate in Washington over the bill which President Bush vetoed to expand the stem cell lines eligible for federal funding. It is also less sanguine than most of the disease advocacy groups that have historically been major supporters of embryonic stem cell research. Public comments by scientists have generally stressed the need for basic research funding, while advocacy groups have pushed for an emphasis on developing treatments. The plan envisions spending $800 million plus on both basic research and applied or “pre-clinical” research, and just over $650 million on clinical trials for new treatments.

2- “NIH free zones”—The draft also calls for spending some $250 million plus on new labs and other facilities that can operate without fear of violating current restrictions on funding ineligible stem cell lines with federal support. While perhaps wasteful and inefficient in the short run, such expenditures ultimately mean that California can formulate its own policies around what goes on in those labs without having to care very much about what the feds do or don’t do. It also means that other states contemplating stem cell research programs funded with their own money are likely to look to Sacramento, rather than Washington, for guidance on how to manage conflict of interest, egg procurement, royalty income distribution, intellectual property and the other complex ethical and legal issues that surround this research. While few other states can afford to spend this much money on new facilities, many appear to be spending smaller amounts of their own money or are relying on private giving or other sources to separate federally supported research from that supported by other financing sources. There may be a lot more of these states after elections in November—there’s a constitutional amendment on the ballot in Missouri, and several gubernatorial candidates of both parties have made support for stem cell research major elements of their platforms.

The development of funding streams independent of Washington and dedicated research infrastructure free of federal funding restrictions means that if federal policy makers do decide to do something definitive on stem cell research, it may not have much effect on anything. Having spent the money on new facilities and done the political heavy lifting to get ethical and commercial agreements in place, states, companies and universities may well decide that they like things the way they’ve got them and they don’t need to pay attention to the feds.

Jim Fossett, AMBI Federalism and Bioethics initiative

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