California's groundbreaking $3 billion stem cell initiative was the brainchild of state Sen. Deborah Ortiz, who saw it as a way to circumvent the conservative politics behind federal funding restrictions on embryonic stem cell research.
The Sacramento Democrat suggested the creation of a voter initiative to ask taxpayers to fund research that has the potential to cure some of society's worst diseases. Experience and early polling showed her the state Legislature would never approve a tax increase to fund the research, but it seemed possible voters would embrace the idea.
But when Ortiz finally saw the initiative, which was written by politically savvy patient advocates, she saw gaps that troubled her. And since voters approved the measure in November 2004, she has been one of its most dogged critics.
Ortiz, who campaigned in favor of the initiative, said she did so on the theory that it would be best to get voters to endorse it and then worry about fine-tuning it.
Over the past 18 months, she has been an author or co-author of several pieces of legislation seeking to increase government control and public oversight of the California Institute for Regenerative Medicine, which was created to disburse the stem cell research money.
These days, as Ortiz's time as a senator ticks away because of term limits, and she campaigns for secretary of state, a good chunk of her calendar is devoted to butting heads with people running the stem cell institute over Senate Bill 401, her latest attempt to change the initiative.
SB 401 is a constitutional amendment that would go before the voters and, if enacted, toughen the conflict of interest, intellectual property and public records components of Proposition 71.
_I really believe these policies need to be in place, not just to protect taxpayer money but because . . . if it fails, or disappoints the public, it could doom people's confidence in stem cell research and the initiative process,_ Ortiz said.
But her efforts frustrate and anger the staff and governing committee of the institute. They are expected to discuss SB 401 at a committee meeting today in La Jolla.
_To me (SB 401) is death by 1,000 cuts,_ said committee member Dr. John Reed, who heads the Burnham Institute in La Jolla.
The institute's oversight committee and staff have spent the past 18 months holding multiple public hearings and gathering public consensus to create the institute's policies and standards. But they still are not complete.
Meanwhile, the agency has been embroiled in court challenges that have prevented it from giving out more than one round of small training grants. Recently a Superior Court judge ruled the initiative was constitutional, but appeals are expected to continue for at least another year.
Long work days at the institute have led to working policies for conflict of interest, intellectual property and medical and ethical standards. Once the public hearings are complete, revisions will be made to the policies, which mean it could be more than a year before the final regulations are adopted.
_Let's not rush into this with an initiative that amends what we're doing before the public input is in,_ Robert Klein, chairman of the oversight committee said at its April 6 meeting.
The oversight committee voted at that meeting to send Ortiz a letter that stated: _SB 401 is unnecessary and premature . . . we oppose it._
Several members of the committee questioned why Ortiz would seek to derail their work.
_I think we have been operating in extraordinary good faith trying to deal with all of these issues,_ said committee member Dr. Philip Pizzo, dean of Stanford University's Medical School. _I find it to be quite distressing to see the potential for what, in essence, unwinds a lot of the work that we've been doing and moves down a very different pathway._
Ortiz expects the bill to next be up for Senate consideration in August. But even if it passes through the necessary legislative committees, voters would not vote on the amendments to Proposition 71 until June 2008, long after Ortiz has left office, according to her staff.
_This is sort of one of the last runs of my service in the Legislature, and it's an uphill battle,_ Ortiz said. _I wish I didn't have to do this._
She said her activism on these issues might have been avoided if the initiative were better written. That is a direct blow to Klein, an author and now the institute oversight committee chairman, with whom she has had a contentious relationship.
A few short sentences further defining conflict of interest, or guaranteeing a specific return to the state when taxpayer-funded discoveries are sold, could have gone a long way in avoiding some of these legislative battles, she said.
Proposition 71 prevents the Legislature from meddling with it for the first three years. That didn't stop Ortiz, who filed her first bill to restrict how research money was spent just one month after voters approved the initiative.
That and every subsequent bill she proposed has prompted institute oversight committee members and staff to meet with Ortiz. Institute insiders say comment from Ortiz and others influenced the working policies the institute ultimately adopted.
_Much of what they have done with regard to policy is because I moved bills, or attempted to move bills, that prompted interplay between me and the (institute),_ Ortiz said. _As uncomfortable as that has been, I think it will be a role I will play until I am gone from the Legislature._
While the senator should get credit for influencing institute policy, there have been a lot of other people pushing for change, said John Simpson, of the Santa Monica-based Foundation for Taxpayer and Consumer Rights.
Along with his organization, the Center for Genetics and Society in Oakland has also pushed for increased accountability and other changes.
Sometimes Ortiz did more than influence policy.
In March, lawmakers approved a performance audit of the institute, which was proposed by Ortiz and 10 other legislators. Proposition 71 also required a financial audit. Both audits are now under way, and results are expected to be made public before year's end.
Because Ortiz has not been dissuaded by the institute's efforts and audits, critics charge that she's using the high-profile stem cell initiative to elevate her political profile during a campaign season.
Ortiz denies the charge.
_For all the criticism I've received, it would have been politically smart of me to just shut up and embrace and defend Proposition 71 and raise lots of money from biotech interests. But I chose not to do that,_ said Ortiz, whose campaign has collected more than $500,000 in contributions.
In response to this criticism, input from the institute and comments made at a May 17 Assembly Appropriations Committee meeting, Ortiz said she intends to amend her bill to make it clear that it will not go on the ballot until after the November 2006 election.
She also said she will amend the bill's intellectual property provisions so that they mirror the regulations the institute has already adopted, and which are now under review by the state Office of Administrative Law.
She's also made concessions to let the institute dictate how much return the state will demand when Proposition 71-funded discoveries are sold.
Nonetheless, the institute continues to take issue with the remaining proposals.
Among the points remaining in the bill is a requirement that the state Attorney General's Office review all licensing deals surrounding discoveries made with institute funding.
The bill would also make the public meetings and records law applicable to the institute's working groups, which include out-of-state volunteers who read grant applications and made recommendations on who should receive funding.
_These fixes make Proposition 71 less vulnerable to future litigation,_ Ortiz said, _and gives the state teeth in enforcing its intellectual property agreements._
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