The Center for Genetics and Society supports the public funding of appropriately regulated human embryonic stem cell research. Together with other public-interest organizations, however, we have raised concerns about many aspects of Proposition 71 and about many shortcomings of the California Institute for Regenerative Medicine (CIRM) since its inception in late 2004.
Unaccountable power, conflicts of interest, and closed door meetings
Proposition 71 vested control of $3 billion of public funds in the CIRM's governing body, the Independent Citizens Oversight Committee (ICOC). This board is dominated by people who are part of or close to the institutions and companies that will benefit from the public funds. It includes no representatives of broader public interest constituencies, such as public health, women's health, or consumer protection advocates.
In addition to these built-in conflicts of interest, some individual members of the ICOC have personal conflicts of interest based on business and financial relationships.
Proposition 71 exempted the CIRM from California's laws governing open meetings, public records, and conflicts of interests. Under pressure from legislators and public interest groups, the CIRM has agreed to some limits on those exemptions, but the policies it has adopted remain inadequate.
Lack of protection for research subjects and egg providers, and lack of other important ethical safeguards
Proposition 71 also exempted the research activities funded by the CIRM from "other current or future state laws or regulations." This is particularly worrisome because of the novel ethical issues raised by stem cell techniques and by research cloning (somatic cell nuclear transfer), which the initiative prioritized as a method of deriving stem cell lines.
Research cloning requires many human eggs, and the women who provide them will in effect be the first research subjects in this field. CIRM has resisted proposals to establish strong policies ensuring the health and safety of women egg providers.
The ICOC has research standards that are helpful in some key areas but lack effective oversight and enforcement provisions, and are inadequate in other regards as well.
Although reproductive cloning is illegal in California and prohibited by Proposition 71, there are no laws against it in 38 states, at the national level, or in most other countries. CIRM policies do little to prevent its funds from being used indirectly to support such unacceptable activities. Nor do they provide adequate safeguards against the misuse of stem cell techniques for the creation of genetically modified children.
Expensive treatments and drug company profits
Proposition 71 is largely silent on intellectual property rights and other legal and financial arrangements that are to be established to develop stem cell-based therapies. However, the "Yes on 71" campaign assured voters that the state would be able to receive a share of any royalties generated by fees obtained through the licensing of techniques developed with pubic funds-a revenue source worth up to $1.1 billion.
CIRM leaders have repeatedly stated their desire to give special priority to projects involving research cloning. As noted, this procedure involves large quantities of women's eggs. Any therapeutic treatments that rely on research cloning are likely to be very expensive and well beyond the means of most Californians. However, there are no constraints on the profits that would accrue to pharmaceutical companies marketing these high-priced therapies. Californians should not have to simultaneously subsidize therapeutic treatments for the wealthy and profits for the drug industry.
Misplaced funding and research priorities
Research on stem cells holds promise, and public funding of it is appropriate, but it is difficult to justify committing $300 million each year for ten years to this single area of research. Under Proposition 71 these funds can be redirected only with great difficulty, even if the research itself suggested more promising directions.
This major commitment of taxpayer dollars for a questionable area of biomedical research is taking place at the same time when essential public services, including public health services, are facing dramatic cutbacks, and twenty percent of Californians are still without basic health insurance.
Proposition 71 amended the California state constitution to include a "right to conduct stem cell research"-a sort of "right" very different from the kinds of fundamental public protections that state constitutions are meant to provide. This constitutional language may make it difficult for the state to regulate stem cell research in ways that the great majority of Californians would find reasonable and necessary.