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Statement to Institute of Medicine Committee on the California Institute for Regenerative Medicine

by Marcy Darnovsky
April 10th, 2012

My name is Marcy Darnovsky; I am Associate Executive Director of the Center for Genetics and Society. Thank you for the opportunity to speak before this Committee, whose appointed role we welcome.

The Center for Genetics and Society is a public interest organization that works to encourage responsible uses and effective societal governance of emerging human biotechnologies. We work with a growing network of advocates and scholars who share a commitment to defining a new kind of progressive bioethics, one that can help ensure that technologies and practices in the life sciences are aligned with social justice, human rights, and other public interest values.

As a California-based organization, we were very interested in Proposition 71, which established the California Institute for Regenerative Medicine as a public agency. When we read the ballot measure, we found we could not support it; when it passed, we worked with other public interest groups who like us support embryonic stem cell research that is conducted with appropriate oversight, to monitor CIRM and to encourage it to adopt good government policies and robust ethical standards, and to publicize what we considered to be flaws that needed to be addressed.

Although CIRM was created by a ballot initiative, it is far from a model of democratic governance. In short, it is a public agency authorized to spend significant sums of taxpayers' dollars while remaining unaccountable to the voters and their elected representatives. Conflict of interest is a major problem: While CIRM has adopted standard policies requiring board members to recuse themselves from decisions that present direct financial conflicts, conflicts of interest are in fact built into its structure: Its governing body is required by Proposition 71 to be dominated by people who represent research institutions that are major recipients of its grants. The ICOC includes representative of biotech companies and of disease advocacy groups, but it has no voices or perspectives independent of these specific constituencies and institutions.

Proposition 71 insulates CIRM from democratic oversight with an unprecedently high barrier. Legislative modification of any sort was prohibited for three years; even now any legislation requires both a 70% super-majority in the Senate and the Assembly and the governor’s signature. Proposition 71 contains other exceptions to the norms of governance in California. It specifies that CIRM can set its own rules – it specifically exempts the research it authorizes from “current and future state legislation.” It exempts the three powerful Working Groups which advise the ICOC from the Political Reform Act and the Bagley-Keane Open Meetings Act.

Californians voted to establish CIRM in large part because of what they were told during the Prop 71campaign. They were explicitly told that the $6 billion investment they were being asked to make would pay for itself in reduced healthcare costs and increased economic activity. They were told in floods of television ads that medical miracles were all but certain and breakthrough treatments were imminent; “Cures for California” was in fact the name of the Prop 71 campaign.

Yet in spite of the implicit and explicit promises made during the campaign, Prop 71 contained no guarantees of economic return to the state, and no assurances that any successfully developed treatments would be affordable for and accessible to the people of California.

Beginning immediately after the passage of Prop 71, the state’s major newspapers began publishing editorials and news articles echoing these concerns and drawing attention to questions about CIRM’s leadership. Even some long-time champions of embryonic stem cell research and supporters of Proposition 71 expressed alarm. Democratic state Senator Deborah Ortiz held a hearing in March 2005 to explore her growing concerns. As just one example of CIRM’s rejection of democratic oversight, Robert Klein initially refused to participate in Senator Ortiz’s hearing, saying “the Legislature is not needed.” And in just one example of the increasing unease with which CIRM was being viewed, a May 2005 Sacramento Bee editorial called Klein a “rogue operator.”

In January 2006, the Center issued a report that graded CIRM’s progress on 12 key subjects, with an overall assessment of C–. In November 2008, we presented testimony to the Little Hoover Commission on California State Government Organization and Economy that included specific recommendations for assuring greater accountability and addressing conflicts of interest on the ICOC and in the agency’s powerful working groups and for bringing CIRM under the clear authority of California’s elected officials.

Especially because this committee’s mandate includes an assessment of CIRM’s initial processes, and consideration of the lessons to be learned from the history of efforts to build public support for CIRM’s work, I refer you to a report on CIRM that we issued in 2006 and the testimony we gave to the Little Hoover Commission in 2008, both on our website. I should also say that the Center was more closely engaged in those early years than it has been recently.

We recognize that CIRM’s leadership has changed since its early years. We acknowledge and welcome the changes CIRM has made in response to the issues raised by the Center, by other public interest groups, and by the Little Hoover Commission.

For example, meetings of the Working Groups are now public unless there are specific reasons to close the doors. CIRM’s intellectual property policy now provides for some returns to the state, and a degree of accessibility to successful products developed with public funds, although there is room for improvement. However, these policies remain subject to modification by the ICOC.

But many aspects of our early concerns remain directly relevant. The requirement for 70% super-majorities means that there is still no meaningful oversight of CIRM by elected officials. The ICOC is still tainted by its built-in conflicts of interest. It still includes no representation of the public beyond disease advocates. Members of CIRM’s powerful Working Groups, including the one that reviews grant applications, are still not required to publicly disclose their individual financial interests.

Given that hundreds of millions of dollars remain to be disbursed, and the widely mooted possibility that CIRM will develop a role that continues beyond the public funding stream that was allocated in 2004, now is the time to clarify and address these issues.

I must also mention the damaging legacy left by the exaggerated promises that characterized the Prop 71 campaign. It’s not surprising that cures have not materialized on schedule: science seldom works that way. But it is surprising that reputable scientists campaigning for Proposition 71, and others in the stem cell field, indulged in statements that they must have known to be hyperbolic. Their litany of stem cell hyperbole has contributed to today’s widespread public confusion about the state of the science – an environment in which patients’ hopes are raised only to be dashed, and in which fraudulent treatments are successfully peddled. In a broader sense, it contributes to unrealistic public understanding of how scientific advance works, and to mistrust of science in general. CIRM has spent a lot of money on public relations, but has yet to address these harms of stem cell hyperbole.

In structural terms, a key question now is what will happen after CIRM’s public funding is exhausted. According to CIRM’s transition plan, another bond measure for additional public funding “would be premature at this time,” but is still on the table. In our view, any additional public monies for CIRM would have to be justified in an analysis that emphasized health care priorities and health care disparities. While there is always tension between the allocation of public funds to scientific research and to other public goods, given our state’s economic decline and budgetary crisis, with so many critical social programs being gutted, we believe it would be simply wrong to ask Californians to set aside more money for one avenue of research, however important.

The other possible funding sources listed in the transition plan are disease foundations, federal funding, venture philanthropy and biopharmaceutical companies. These options raise important questions about CIRM’s continuing obligations to the people of California.

We are concerned that increased private funding could exacerbate the current problems of inadequate accountability, and that a greater reliance on private funds could raise new questions about conflicts of interest. We think it important to note that no amount of private funding would relieve CIRM of its public obligations. Having been set up as a public agency, and operated with a significant sum of public funds, CIRM has acquired ongoing responsibilities to the California public.

If CIRM were to continue with other funding sources, we believe that several changes would be minimally required.

• First, the agency’s governance structure and practices should be brought into line with those of other public bodies. One possibility, as we suggested in our testimony to the Little Hoover Commission, would be to make CIRM an agency within an existing state department, an arrangement used by stem cell research funding programs in several other states. Another would be reconfigure CIRM’s governing board both to address governance issues and to address its built-in conflicts of interest and include public representatives.
• Second, CIRM must be made accountable to elected officials by lowering the exceptionally high bar for legislative modification to Proposition 71.

• Third, California taxpayers need to be assured, by legislative action if necessary, that their interests in CIRM are being recognized and safeguarded. A $6 billion public investment has been made, and it should not wind up enriching a set of private investors through a process shot through with conflicts of interest.

•Finally, Californians must be assured that any successful treatments that derive from this investment are made accessible and affordable, including to the low-income citizens of our state.
Many of the issues raised by CIRM’s establishment and operation exemplify the challenges of science in a democratic society. If the scientific enterprise in general is to maintain the public’s trust – and in all too many cases it must now work to regain that trust – it will have to find better ways to deal with conflicts of interest, accountability to public officials, and transparency to the public at large.

CIRM has from the start taken on two experiments: one in a new field of biomedical investigation, the second in politics and policy. We believe that public oversight and democratic governance are not hindrances to scientific advances; that they are in fact essential both to good science and to good policy. CIRM still has an opportunity to model how responsible research and the public interest can move forward together. We hope it will take full advantage of that opportunity.

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