CIRM to NIH: Forget You?

Optimistic Democrats and some stem cell scientists believe that this fall's elections are part of a trend that will trigger a veritable torrent of funding for embryonic stem cell research. But that amounts to little more than wishful thinking.

Certainly funding may increase somewhat if the political winds shift to a favorable direction, but there is no guarantee of that. Even with a president in 2009 who might support stem cell research, enormous federal budget deficits will continue to plague the country, and optional research is not likely to suddenly surmount that obstacle.

Moreover, California has embarked on a go-it-alone course that other states are emulating. California's position was reinforced in the draft of its strategic plan that will receive a full-blown hearing in Los Angeles on Tuesday and Wednesday. The actions by California and others are making the NIH – dare we say it – a tad irrelevant, at least in terms of embryonic stem cell research.

Writing in the blog of the American Journal of Bioethics,
James Fossett of the Rockefeller Institute’s Federalism Research Group noted that CIRM's plans include creation of "NIH-free zones." That will cost $250 million, compared to NIH funding currently of about $30 million annually for ESC research. Fossett wrote:

"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."

He continued:

"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."

Indirectly supporting Fossett's position was a Sept. 1 column in the Wall Street Journal by Sharon Begley. The piece focused on the impact of tight funding at NIH. The headline read: "A Smaller NIH Budget Means Fewer Scientists And 'Too-Safe' Studies."

Begley wrote that in 2004

"...Congress and the White House, calling for reduced budgets in the wake of tax cuts and a growing deficit, slammed on the brakes. Ever since then, NIH's budget has been flat or, adjusting for inflation, down. The chance that a scientist's work will be funded fell to 22% last year from 27% in 1995, and to less than 10% in some fields. Now the warnings are coming true: The plug is being pulled on promising research by scientists with solid track records.

"'When 27 percent of proposals were funded, it wasn't that hard to separate the top quarter, says molecular biologist Keith Yamamoto of the University of California, San Francisco. 'There was a natural cutoff,' he says. But at 10 percent 'the ability to distinguish a grant that deserves funding from one that does not vanishes. It becomes a crapshoot, with every grant in jeopardy.'"

The NIH and its enormous sway over research will not disappear any time soon. But it is an aging insitution, hobbled by its reliance on the good graces of the president and Congress, where a handful of truculent lawmakers can raise considerable mischief with its funding. CIRM does not share that weakness. Neither the California legislature or even the state's Terminator governor can fiddle with the agency's plans or restrict its budget.

An old cliché with considerable truth holds that pioneers are the ones with arrows in their backs. At the same time, pioneers snatch up the best land, the most favorable water rights and set the agenda for the latecomers. That favored position is where CIRM now finds itself.