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California stem cell program still missing the mark

Genetic Crossroads
February 23rd, 2006

Draft research standards adopted last week by the governing board of the California Institute for Regenerative Medicine (CIRM) remain fundamentally flawed. The standards are critical for protecting women from the significant risks of providing their eggs for cloning-based stem cell research, and in determining whether the endeavor will open the door to abuses such as reproductive cloning.

The CIRM governing board also adopted an "affordable pricing" provision, and policy that will affect return of taxpayer investment in stem cell research. Some money will now be returned to the state, although campaign promises that the program will "pay for itself" remain unlikely to be filled.

Op-ed by CGS:

Opinion: Jesse Reynolds, "State's stem-cell research needs independent oversight," San Jose Mercury News (February 10). "Too much is at stake with stem-cell research to rely on what may amount to self-regulation…[T]he local committees must be overseen by a transparent and accountable body independent of the research institutions, the CIRM, and the insider's network of scientists."

Standards on procuring eggs for research, but no way to enforce them

While the research standards adopted by the governing board of the California Institute for Regenerative Medicine (CIRM) have some improvements in the details, the core of the policy remains inadequate. It leaves the approval of research protocols to local "Stem Cell Research Oversight Committees" that will be formed by, and affiliated with, the institutions doing the research.

These committees will consist largely of stem cell researchers themselves and their colleagues from related scientific fields, whose sympathies and loyalties are likely to lie with their institutions and with the research. Further, there will be no oversight of these committees, and key information will not be available to the public for scrutiny.

The CIRM has responded to public pressure by closing a loophole that would have allowed women to be paid to provide eggs. The proposed standards also require that research institutions cover the costs of any immediate health consequences from the egg extraction procedure. However, these provisions are likely to be poorly enforced in a system that amounts to self-regulation.

Marginal improvement of prospects for returns on stem cell investment

The intellectual property policy addresses the question of how to manage profits from products developed with CIRM funding. It will help to determine both whether California will receive financial returns on any successfully developed medical treatments, and whether those treatments will be widely affordable.

The campaign for Proposition 71, which created the program, repeatedly promised that the program would pay for itself. Part of this repayment, voters were told, would come from a share of profits from any successful invention or discovery. The campaign estimated that this would contribute up to a billion dollars of the program's $6 billion cost. As the agency took shape, however, its leadership resisted following through with this promise.

CIRM's leaders also initially rejected calls to adopt policies to ensure that any therapies would be economically accessible to all Californians. This is particularly important because of the likelihood that any therapies based on stem cell research will be extremely expensive.

After criticism mounted from public interest groups and legislators led by Sen. Deborah Ortiz (D-Sacramento), a proposal was adopted that will set aside a quarter of the profits for the state, after the first $500,000. The intellectual property policy will also allow the state to purchase any therapies at lower prices for programs such as Medi-Cal, and will require manufacturers to provide them to uninsured Californians.

The state's share of revenues under the new policy on intellectual property is unlikely to make a significant dent in the $6 billion cost of the program, and it is far from clear that this huge public investment in stem cell research is the best use of funds to promote the health of most Californians.

Related articles:

"Ortiz wants audit of stem cell institute," Sacramento Business Journal (February 22)

­ Editorial: "Stem cell transparency,"Los Angeles Times (February 20)

Editorial: "Stem cell institute responsive, to a point," Sacramento Bee (February 14)

"State's stem cell institute adopts 2 ethics policies," San Diego Union Tribune (February 11)

"Stem cell research regulations mulled," San Diego Union Tribune (February 1)


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