CGS: CIRM Turns in Mediocre Performance; Klein Should Quit

The Center for Genetics and Society Wednesday gave the California stem cell agency a mediocre "C minus" grade and called for the resignation of its chairman, Robert Klein.

The 32-page report card by the Oakland-based watchdog group said, "CIRM's first year has been a great disappointment."

"In terms of governance, the CIRM has often failed to operate as an accountable,responsible, and transparent state agency. In the area of politics, it has failed to establish a cooperative relationship with state legislators. And in the policy arena, the CIRM has fallen far short of the expectations raised during the initiative campaign that led to its creation: It has so far failed to adopt policies to ensure that any successful stem cell therapies will be affordable to most Californians, or to reassure Californians that they will see any share at all of financial returns that the research they are funding may generate," CGS said.

In response to our inquiry, CIRM spokeswoman Nicole Pagano said the agency had a "great first year."
Her statement (the full text follows this item) said,

"This is the kind of criticism-based activism that seems designed more for publicity than any practicable purpose.

"They have been working against Proposition 71 since the beginning, despite the overwhelming support of voters in California who approved the measure well over one year ago.

"Their report rehashes old issues that they have already expressed to our board; which they have duly considered and addressed."

The center is a nonprofit group based in Oakland that supports embryonic stem cell research. Members of its staff have regularly attended meetings of the agency and its subcommittee during the past year, testifying about the center's concerns.

The center gave CIRM "D" grades in the following areas: "maximizing health equity," minimizing conflicts of interest, cooperating with the state legislature, providing responsible leadership. The agency received its best grades – "C plus" – for establishing ethical safeguards and research standards and protecting women who provide eggs for research and other research subjects.

Klein came in for considerable criticism by CGS:

"…(Klein) has misused his authority in ways that have significantly undermined trust and confidence. His missteps and arrogance have been widely noted. The editorial page of the Sacramento Bee, for example, has dubbed Klein the 'self-appointed czar' of the stem cell research program and a 'rogue operator.'"

Marcia Darnovsky, associate executive director of the center, told reporters during a conference call that Klein had operated CIRM "more like a private enterprise than a public agency."

Another CIRM critic commented on the call for Klein to resign. John Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights of Santa Monica CA, said:

"I certainly understand the public outrage that led to the call for Bob Klein to step down, but the stem cell institute's problems go beyond personalities. We'll just have a revolving door of Bob Kleins until the structure is fixed. Fixing the stem cell institute requires two things: First, it needs to follow all of California's good government laws and behave like any other state agency. Second, the institute needs to adopt rules controlling ownership of any Proposition 71-funded medical discoveries that are based on the foundation principles of affordability, accessibility and, accountability."

Today's CGS report card cited the built-in conflicts of interest at the agency and noted the coziness of such arrangements:

"The relationship between the ICOC (CIRM's board of directors) and the institutions it funds can be seen in the first round of training grants, announced on September 9, 2005. Of the 16 institutions that were awarded almost $40 million, 14 are represented on the ICOC. Viewed another way, all but two of the 17 ICOC members affiliated with an institution eligible for this round of funding saw their institutions receive grants."

On the "health equity" issue, the report said,

"To date, CIRM leadership has resisted the inclusion of affordability and accessibility of stem cell treatments as a key criterion in its policy considerations."

It said CIRM "could require that any successful therapies developed with its money be made available to the state’s medical insurance programs at reduced or no cost. Or it could require grant recipients to set aside a portion of any IP revenue in an accessibility fund."

CGS said CIRM has put in pace stem cell research guidelines recommended by the National Academies, but those are inadequate in some areas.

During the conference call among reporters, CIRM officials noted that while CIRM can set standards for only the research it funds, there are no state or federal standards for stem cell research. They suggested that the state legislature and CIRM work together to develop consistent standards.

CGS also gave CIRM a "C plus" for protection of women, but noted that there are no provisions for helping women egg donors who suffer serious side effects from the egg donation process.

The center's report said that CIRM faces "regulatory challenges never previously confronted by any other public body in the United States."

"While some of its difficulties may be 'start-up' problems that might be expected in any effort this large, the greater bulk are the result of numerous missteps and misjudgments, resistance to legislative and public oversight, and a tendency towards arrogance in the face of criticism."

It continued:

"We believe it is incumbent upon the CIRM’s leadership, staff, and board to enter the institute’s second year with a new spirit, one that acknowledges—in deeds as well as words—the need for transparency, accountability and public oversight."