California's Legislature and the state's $3 billion stem cell research institute are engaged in a dangerous game of political chicken. No one will win if both keep careening toward the ballot box. In hopes of avoiding such a smashup, we offer a compromise.
Sen. Deborah Ortiz, D-Sacramento, has introduced a constitutional amendment that seeks to correct some of the shortcomings of Proposition 71, the 2004 ballot proposition that allows a select group to dispense $300 million in research funds each year for a decade. Ortiz's bill, SCA 13, would specify how this group should handle open meetings, conflicts of interests and licensing agreements for stem cell therapies.
These are all important issues. Ortiz's solutions are not perfect, but her measure and her long-standing support for stem cell research deserve respect. Instead, the institute's oversight committee and its supporters have launched a campaign to demonize her.
At Monday's meeting, oversight committee member Joan Samuelson, an advocate for people with Parkinson's disease, said Ortiz's measures "will be measured in extra suffering and death."
"How dare she!" said Jeff Sheehy, normally a thoughtful and even-headed advocate for AIDS patients. "How dare she steal hope from the people of California!"
Even more disturbing were the comments of Don Reed, an audience member and patient advocate. He compared critics of Proposition 71 to "Nazis" and left the impression that Ortiz was in that camp.
Before this gets even more ugly, all sides need to take a deep breath and get some perspective. Californians, in contrast to President Bush and his allies of the religious right, have shown their support for embryonic stem cell research. Although some anti-abortion zealots have seized on Ortiz's bill as a possible way to scuttle Proposition 71, Ortiz and most lawmakers simply want to improve the law. Legislators, who surely will be blamed if Proposition 71 leads to scandal or squandered funds, have an obligation to seek these improvements. Here's how they can go about doing so.
Conflicts and peer review
One key issue is how to ensure "peer review" of multimillion-dollar research grants that is credible and free from conflicts of interest. So far, the institute's board has picked a stellar group to recommend grants, but has adopted a weak policy to protect against conflicts. Under this policy, reviewers are expected to recuse themselves if they have a financial interest or other conflict. But they would not need to publicly disclose stock holdings or consulting relationships that might affect their decisions.Ortiz thinks this policy is inadequate, and she is right. Unfortunately, her solution overreaches. Ortiz wants the peer reviewers not only to disclose their biomedical stock holdings, but also to divest those holdings or put them in a blind trust. This requirement might discourage some eminently qualified scientists from serving. Public disclosure - similar to what is required for state officials - should be the rule here.
Ortiz also wants peer reviewers to hold their deliberations in public, except when considering matters that involve intellectual property rights.
This is a difficult issue. For decades, academics have grown accustomed to peer review sessions that allow them to meet behind closed doors and rip apart their colleagues and competitors. Advocates say this system promotes candid evaluations and the best research. Although there is no scientific study to support this contention, confidential peer review is a fixture of modern academia. Requiring all peer review meetings to be open may be unrealistic.
On the other hand, there is no reason these meetings need to be completely closed. Peer reviewers could easily hold open discussions on whether proposed research projects meet the institute's goals and criteria. Then they could move into private sessions to discuss the reputations and qualifications of applicants, consider patent issues and conduct the final scoring. This type of hybrid would help inform taxpayers (and the oversight board) about the projects they are financing, without discouraging candid discussions.
Ortiz also wants to ensure that Californians of modest means have access to stem cell therapies once such therapies are commercialized. A current draft of her measure requires that therapies be made available at cost "to California residents who are eligible to receive assistance through state and county health care and preventive health programs."Ortiz's intent is admirable, but this provision is premature. Scientists are still years away from full and final testing of embryonic stem cell therapies, and the institute's oversight board is many months away from discussing their eventual licensing. Lawmakers could easily wait two years before delving into this issue. At that point, they will have legal standing under Proposition 71 to amend the law without a constitutional amendment.
Meeting Monday, the institute's oversight committee voted to move the June 6 session to Sacramento so committee members could lobby against Ortiz's legislation. Before they launch an all-out assault on Ortiz and her bill, they should consider the merits of this compromise. They should think about the consequences of refusing to budge and continuing to alienate lawmakers.
If members of the oversight committee are not willing to accept reasonable compromises soon, they set the stage for disaster two years from now. At that point, legislators may be tempted to strip this oversight board of its current members and substitute their own picks. The oversight committee has the power to keep this from happening. The question is whether the members will come to their senses in time to do so.
This site contains copyrighted material the use of which has not always
been specifically authorized by the copyright owner. We are making such
material available in our efforts to advance understanding of
biotechnology and public policy issues. We believe this constitutes a
'fair use' of any such copyrighted material as provided for in section
107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section
107, the material on this site is distributed without profit to those
who have expressed a prior interest in receiving the included
information for research and educational purposes. For more information
go to: http://www.copyright.gov/title17/92chap1.html#107. If you wish to use
copyrighted material from this site for purposes of your own that go
beyond 'fair use', you must obtain permission from the copyright owner.