Friday, February 10, 2006

Governing board of California's stem cell body (CIRM) to address patent issues

from the San Jose Mercury on California's stem cell program:

The first proposal addresses the question of how to manage profits from products developed with funding from the new California Institute for Regenerative Medicine. The policies the CIRM adopts now will determine both whether the state and the voters of California will receive any return on our investment in the program, and whether any successfully developed medical treatments will be 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 [ie, patent royalties], which would contribute up to a billion dollars of the $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 are economically accessible to all Californians. This is particularly important because of the likelihood that any therapies from stem-cell research will be extremely expensive.

After criticism mounted from public-interest groups such as the Center for Genetics and Society and legislators led by Sen. Deborah Ortiz, D-Sacramento, a proposal emerged that would set aside some of the profits for the state. The policy would also allow the state to purchase any therapies at low prices for programs such as Medi-Cal, and would require manufacturers to provide them to uninsured Californians.

The second set of proposed policies details the ethical standards for research to be conducted with CIRM funding. Much is at stake here. For example, some of the research is expected to use cloning techniques to create early-stage embryos to derive stem cells. Thousands of women's eggs will be needed for this. Will the women who undergo egg extraction procedures, which involve significant risks, be adequately protected? Will researchers be allowed to pay women for providing eggs, a practice that could induce economically vulnerable women to put their well-being at risk in order to pay their bills?

Furthermore, creating clonal embryos opens the door to creating clonal babies. Although this is prohibited by California law, the research standards need to take concrete steps to prevent it.

Last week, a CIRM advisory committee met to develop recommended research standards. Among these, women who provide eggs would only be reimbursed for their expenses, and institutions would cover the costs of any immediate health consequences from the egg extraction procedure. Researchers would track eggs and embryos so that any misuse, such as attempts at reproductive cloning, would be easier to detect. This reporting would be public information.

The CIRM board should carefully look at the still-unfolding stem-cell and cloning-research scandal centered in South Korea for a lesson. Supposedly, an oversight board had been monitoring that research. But in the overheated environment of stem cell research and scientific competition, the board had no real power. Hwang Woo Suk's ethical breaches came to light only after journalists revealed that he had inappropriately obtained women's eggs. [IPBiz note: this is one of the ethical breaches, not the only one. Submitting fake photos and making false claims is also an ethical breach.]


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