Last November, California voters overwhelmingly approved Prop. 71, which created the California Institute for Regenerative Medicine to fund stem cell research on a large scale. The initiative created an oversight committee that was to be made up of various stakeholders who were to be appointed by elected officials as well as representatives from the leading public academic institutions in the state. The result is a committee that includes representatives for a variety of disease advocacy groups, scientists, and a small representation from the biotech industry. This committee has been charged with creating rules and regulations for many aspects of this research, and many of the members of the Independent Citizens Oversight Committee (ICOC) have established track records of thoughtful deliberation on the topics that must be addressed.
One of the key features of Prop. 71 was the way that it insulated the funding and management of CIRM from external oversight or control by the California state legislature. For obvious reasons, when dealing with the tough issues that must be facedhow do we ensure adequate protection and consent for women who donate their oocytes for research, what kind of intellectual property rules should be developed so that we can create incentives for private funding of the development of therapies, without making treatments unaffordable, and at the same time bring a return on investment to California these issues are best left to a group like the ICOC with assistance from experts (such as the working group that is to be created under terms of Prop. 71). The last thing we would want is for these issues to become fodder for political gamesmanship in the legislature.
Unsurprisingly, the state legislature is unhappy with the fact that they are not relevant to an important undertaking within the state. State Sen. Deborah Ortiz (possibly motivated by a desire for higher public office) has abandoned her long standing support of stem cell research and is attempting to subvert the expressed will of the people. She is partnering with a conservative opponent of stem cell research to try to enact a constitutional amendment that would allow the state to mandate precisely the sort of oversight that the ICOC is already in the process of developing. This may very well have a large amount of support in the legislature. For the most part, this seems to be simply a desire to be allowed to put their stamp on the efforts of the CIRM. Rather than give the ICOC a chance to see if the actual protections are adequate, Ortiz and her colleagues are trying to rush in so that they can have their fingerprints on the rules and regulations that are likely to be enacted anyway.
The one exception is legislation that is being proposed that would make it illegal for women to voluntarily serve as oocyte donors for the expressed purposes of research (since in practice these women take drugs to superovulate to produce a sufficient number of eggs). It is worth noting that women routinely do this in IVF, and in fact, there is nothing to prohibit women from continuing to produce eggs as surrogates for other people trying to reproduce. Apparently Ortiz believes that assisting reproductively challenged individuals is sufficiently important that women should be allowed to make this decision, but research is not important enough to allow anyone to expose themselves to risk.
This issue highlights the difficulty of turning these matters over to a legislature that fundamentally lacks knowledge or insight into the research process or into the details of the practice of medicine. The citizens of California wisely chose to pass a measure that had built in measures for oversight and public accountabilitythe fact that the legislature is left out is a poor reason to undo the will the people. – David Magnus