John M. Simpson is the director of Consumer Watchdog’s Stem Cell
Oversight and Accountability Project. E-mail him at
[email protected].
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President Barack Obama’s lifting of federal restrictions on stem cell research is a victory for science over dogma, but as we’ve seen with California’s $6 billion stem cell program, science can take a long time.
The California Institute for Regenerative Medicine, or CIRM, first fought off legal challenges and now has awarded $693 million in grants. After four years this gives the state an advantage in competing for federal funding. California has the infrastructure – scientists and laboratories – to put federal money to work immediately. The California program has yet to produce cures; I believe it ultimately will.
But the new active federal role demands a new CIRM approach to maximize the scientific benefits of its grants. What’s needed is a close partnership with the federal National Institutes of Health, in which the state’s institute is the junior partner. And CIRM needs to emphasize science, not hype. For its part, the NIH must acknowledge CIRM’s contributions while the federal agency was largely out of the picture.
During the federal hiatus, California’s institute emerged as the largest funder of embryonic stem cell research in the world. Chairman Bob Klein and President Alan Trounson have been playing on the world stage, forging agreements with other countries that include Great Britain, Canada, Japan and Spain, largely because the federal government was not in the game. Heady stuff, indeed.
California stood in admirably for what should have been an NIH leadership role all along. Now that the feds have returned, California’s institute needs to adjust its mission. Fortunately, the agency is in the midst of updating its scientific strategic plan, a perfect opportunity for self-analysis. This week, it held a public hearing on the draft plan in San Francisco. Today, the agency’s board of directors meets in Sacramento.
Even if a few large egos are bruised, the challenge facing the state’s institute is to relinquish leadership to the feds and figure out how to augment and complement the NIH efforts. There needs to be close collaboration between each organization’s scientists.
NIH emphasizes basic research. CIRM could emphasize funding later-stage translational, preclinical or even early-stage clinical trials. Federal law still prohibits using federal funds to derive new stem cell lines from embryos, though experiments can be funded once the cells lines are established. That is another opportunity for CIRM. The point is that the agency must determine where it adds the most value and concentrate efforts there.
But collaboration among scientific staffs does not mean CIRM should hire the Podesta Group for $240,000 as a Washington lobbyist, as it has just done. Because of California’s economic crisis, the state has been unable to sell bonds to fund the institute. The agency will run out of money around the end of September unless cash is found. Klein hopes to place $200 million in bonds privately this year, but it is by no means certain that will be possible. Husbanding what financial resources are on hand is critical.
Accepting a necessary secondary role to the NIH may be a difficult pill for some at CIRM to swallow, but over the last four years the agency has learned much that it can and should be proud to offer and share with the far larger operation.
One of the California institute’s most important contributions has been the development of regulations that cover ethical standards for stem-cell researchers and intellectual property policies. NIH would do well to use California’s ethical rules as the basis for the regulations that Obama has directed it to draft.
On the intellectual property front, CIRM hammered out rules that include provisions for a payback to the state if CIRM-funded research results in revenue. Federal law doesn’t have such a provision. Obama’s focus on stem cell research provides an opportunity to reform all federally funded scientific research. When venture capitalists provide money to companies, they require clearly spelled out conditions and expectations. There is no reason it should be different when taxpayers put their hard-earned dollars on the line for science. The public should share equitably in the fruits of the research for which it paid.
CIRM was created in response to President George W. Bush’s unwillingness to fund vital research. Four years after the agency was created, the scientific, economic and political landscapes have drastically changed. The California Institute for Regenerative Medicine must adjust quickly on all three fronts if it is to serve the state and science well.
