Promises to keep

AT THE HEART OF CALIFORNIA’S multibillion-dollar experiment in public stem cell research are two promises. One is that such research will save lives. The other is that the scientists conducting it, and the agency funding it, will be accountable. The first is as magnificent as it is exaggerated; the second is more practical but as yet unfulfilled.

That’s the bad news. The good news is that there’s still time for the state agency set up by Proposition 71, which created a $3-billion bond to fund such research, to make good on its promise. All it will take is compromise, common sense -- and maybe a little litigation. The last of these, at least, is starting to have an effect.

Research in the public interest

Any undertaking this big was bound to have early stumbles, but the first year under the stem cell initiative was especially disappointing. To start, the initiative itself has multiple flaws, most of them related to accountability.


The California Institute of Regenerative Medicine was created by Proposition 71, which also freed it from most public oversight and basic rules guarding against conflict of interest.

The agency’s governing board is filled with researchers, industry representatives and patient-advocates. These people have passion and expertise, but also an inherent conflict of interest because they all represent groups likely to seek stem cell funding. The board also needs elected officials and watchdogs to vouch for the public interest.

Proposition 71 forbids any alteration to the structure of the regenerative medicine institute by the Legislature for the first three years, and after that requires an almost impossible 70% approval for any changes. The lack of accountability prompted a lawsuit that has kept the state from issuing any bonds to pay for research. It goes to trial Feb. 27 and, with appeals, is expected to last for more than a year.

As it turns out, that may be a good thing. The opening bumbles of the institute’s oversight committee, and recent reports of a South Korean stem cell researcher who falsified his results, show that shocking things can happen in the headlong race for stem cell discoveries. California must be sure its program is both accountable and ethical before it starts handing out grants.


All this said, embryonic stem cell research deserves public investment that it is not getting at the federal level. California may not get stock options out of its bond, but it stands to benefit by becoming a magnet for the top scientific minds working on cutting-edge biotechnology. Under the governance of a board that understands the importance of public transparency, the initiative’s weaknesses can still be overcome.

But the oversight committee’s chairman, Robert Klein, seems to be allergic to sunshine. Much of the committee’s first meeting had to be scrapped when a public-interest lawyer pointed out that it failed to meet the state’s open-meeting laws. The institute’s first employees were drawn from the Proposition 71 campaign and Klein’s stem cell charity group, ignoring the state’s civil service rules on advertising for the most qualified candidates.

The committee also wanted the meetings of its three major advisory boards, called working groups, held in private, even though one of them reviews applications for research grants and recommends who the recipients should be. The institute’s leaders say they have learned from the public pressure. The institute now advertises for staff openings, and its oversight committee and working groups follow the state’s open-meeting laws.

Unfortunately, the oversight committee continues to insist that members of the working groups, including the research reviewers, do not have to publicly reveal their financial interests in stem cell research. The members of these boards will make crucial recommendations about how to spend billions of taxpayer dollars, and for the public not to know whether they stand to benefit from any particular grant is unacceptable.


The committee does stipulate that members of the working groups reveal their conflicts of interest to the committee itself, but that is inadequate. The world of stem cell research, industry and advocacy is too incestuous for such an arrangement.

When state legislators -- one of them a staunch supporter of Proposition 71 -- proposed a constitutional amendment to make the institute more accountable, Klein and his colleagues reacted badly. Instead of meeting to talk it over, they hired a lobbyist to fight it, an extreme step for a state agency.

The institute is off to a stronger start on research ethics. Thousands of human eggs will be needed for stem cell research, and Proposition 71 prevents women from being paid for eggs beyond reimbursement for actual expenses. That should help ensure that the research does not exploit poor women desperate for money. The oversight committee also was admirably swift to adopt the ethical guidelines that were adopted last year by the National Academies.

The institute has more work to do in this area, work that should be completed before any grants are awarded. It needs policies that provide free follow-up medical care for women who donate eggs, for instance, and especially those who suffer side effects from the procedure.


A suit that could lead to sunlight

The institute’s reasonableness on the ethics issue makes its arrogance and lack of responsiveness on other fronts all the more puzzling. Its intransigence is also counterproductive strategically because it helps feed a lawsuit that could shut down the whole effort or alienate the Legislature.

Even if the lawsuit ultimately fails, with appeals it is expected to stretch well into 2007. By the time it’s all over, the three years under which the Legislature is powerless to amend the initiative will probably be over. If Klein and his supporters continue to rebuff legislators and create a semiprivate state agency, the Legislature might find it easier than anyone believed to summon a 70% vote.

The promise of stem cell research remains strong, as does that of the California Institute for Regenerative Medicine. But as any researcher knows, details matter.


Strengthening the institute’s standards of ethics and accountability will allow it to get on with its bold work with the public’s confidence.