Limits on Stem Cell Agency Proposed

When California voters passed a $3-billion stem cell bond measure last year -- after a multimillion-dollar campaign that promised “Cures for California” -- backers promised to move fast to get money to researchers.

To do so, they said they would bypass traditional -- often slow -- government accountability procedures. So far, the effort to push fast has generated more controversy than speed.

The latest problem for the new California Institute for Regenerative Medicine came Wednesday when a bipartisan group of legislators proposed a package of restrictions on the stem cell agency.

One would be a bill designed to delay for three years any plan to have women donate eggs directly for purposes of stem cell research.

Such a temporary ban would allow scientists to continue doing research on embryos that were created for in vitro fertilization but never implanted in a womb. But it would complicate, and maybe halt entirely, any efforts to conduct “therapeutic cloning,” which was specifically funded by the stem cell ballot initiative, Proposition 71.

Some researchers believe that procedure offers the best opportunities to understand how certain diseases develop.

The other major element of the proposed package would be a constitutional amendment that would require the stem cell agency to live within specified rules on conflicts of interest and open meetings.

If approved by two-thirds of both houses of the Legislature, the amendment could be put before voters as early as November.

The sponsors of the proposals are state Sen. Deborah Ortiz (D-Sacramento), who has been one of the state’s staunchest advocates for stem cell research, and Sen. George Runner (R-Lancaster), an opponent of the research. The bipartisan sponsorship improves the two measures’ chances of passing, legislative aides said Wednesday.

“This is not about refighting Proposition 71,” Runner said. He drew a distinction between the “bright picture painted” during the campaign and the “cloudy” details of how the agency will be operated.

Now three months old, the agency has faced protests about openness and potential conflicts of interest at each meeting of its 29-member board. In a rocky start, the board’s first meeting, in December, was derailed because of complaints that the agency was not complying with the state open meetings law.

And this week, officials from Atty. Gen. Bill Lockyer’s office warned that two lawsuits challenging the constitutionality of Proposition 71 could delay the bond sales needed to finance the agency.

A constitutional amendment is needed “to maintain the public’s confidence, the integrity of this important research and California’s significant financial investment,” Ortiz said.

The restrictions, she said at a news conference in the Capitol, are “what we think are fair parameters for the state’s interest in a $3- to $6-billion investment.” The sale of the bonds is expected to cost taxpayers about $6 billion over the 30-year course of the loans.

Ortiz said the proposal to limit therapeutic cloning stems from her concerns about possible risks to women who would be egg donors. Those risks would be better understood in several years, she said.

The cloning procedure -- also known as somatic cell nuclear transfer -- strips the genetic material from a donor egg and replaces it with the complete DNA of another person.

Scientists believe doing so could allow them to create stem cell lines that would be tailored to study the origins of specific diseases.

But opponents of embryonic stem cell research have focused on therapeutic cloning as a particular point of controversy. Bills aimed at banning the procedure and imposing stiff criminal penalties have twice passed the U.S. House of Representatives.

Backers of the research want to move quickly to fund it in California, believing that if it begins to show results, efforts to impose a ban will collapse.

In addition to openness requirements, the amendment proposed by Ortiz and Runner seeks to ensure that the state would get a share of the profits from any therapies developed out of taxpayer-funded research and that such therapies would be affordable.

Officials of the stem cell agency responded tepidly to the announcement.

The board is “committed to adopting stringent conflict of interest policies and medical and ethical standards -- with input from the public,” Chairman Bob Klein and Vice Chairman Ed Penhoet said in a joint statement.

“In fact, we have now held 13 open public meetings in just 13 weeks,” the two officials said, adding that they welcomed legislators’ “participation in this ongoing process.”

“At the time same time,” Klein and Penhoet went on to say, “the voters of California sent a clear message: they entrusted the institute’s governing board, which is comprised of 29 prominent Californians -- leaders in academia, science, medicine, research, patient advocacy and business -- to move forward with the work ahead.”

Proposition 71 was written by Klein, a Palo Alto attorney who became a stem cell research advocate when his young son was diagnosed with diabetes.

The initiative was intended as a replacement for federal money for stem cell research, which was strictly limited by President Bush. Under Bush’s rules, researchers using federal funds can work only on embryonic stem cell lines created before August 2001.

In writing the measure, Klein was concerned about the possibility of political interference. Legislators might try to raid the bond money in a fiscal crisis, he worried, or opponents of stem cell research might try to block it.

So he crafted the language to largely exempt the new agency from government oversight.

But Klein’s insistence on avoiding oversight and his sometimes-combative style have alienated some legislators and advocates of open government.

On Wednesday, Ortiz denied that her efforts at government oversight were “personal” with Klein, who did not show up last week when she scheduled a legislative oversight hearing.

“Mr. Klein worked hard and deserves the credit for putting forward the policy, she said. “I think there has been a little skittishness on the part of people who worked on the campaign about interference, but this is bigger than Mr. Klein.”

For his part, Klein praised Ortiz for her leadership in the area of stem cell research.

“Sen. Ortiz and the California Institute for Regenerative Medicine share the same goal,” Klein said in his statement: “to support stem cell research and to ensure that California leads the way for finding cures for people with disease, illness and injury.”

Several board members, who were appointed by the state’s top elected officials, also said they looked forward to working smoothly with legislators.

“There’s a large degree of consensus that we have to hold ourselves to the very highest standards and expectations in terms of conflict of interest, intellectual property, sharing back with the state, and doing things in a clear and appropriate manner,” said Dr. Michael Friedman, a board member and director of City of Hope, the cancer research center based in Duarte.

“What we want is speed,” he said, “not haste.”