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Scientific panel recommends changes to California’s stem cell institute

The California Institute of Regenerative Medicine (CIRM) today received a mixture of praise and hard-to-enact recommendations from an august scientific body.

Last summer, CIRM asked the Institute of Medicine (IOM) to gather a group of experts to assess the performance of the stem-cell institute, which has distributed more than US$1.3 billion to California researchers at dozens of institutions. CIRM paid $700,000 for the assessment.

The IOM study panel has now released 176 pages detailing its findings. They call for a reconstituted board with less oversight of day-to-day operations and fewer conflicts of interest, the creation of a scientific advisory board, funding for training programmes in ethics and stem cells and establishing policies friendlier to industry.

It’s unclear what effect the report will have. Many of these recommendations run counter to requirements enshrined in the legislation that created CIRM, and the board of CIRM has heard similar recommendations before and failed to act on them. “The IOM’s critical report echoes what every independent evaluator has said in the past,” said John M. Simpson, Consumer Watchdog’s stem-cell project director, in a statement.

Human embryonic stem cells

Wikimedia Commons

Jonathan Thomas, head of CIRM’s oversight board, praised the thoughtfulness and thoroughness of the IOM panel, saying that he was “very happy for the many validating comments”. What will happen next is still uncertain, he says, particularly because CIRM may not be able to enact recommendations without seeking permission from California’s legislature or even voters.

The IOM is scheduled to present its findings to CIRM’s board next week, and a workshop to study the recommendations has been planned for January.

Most of the IOM recommendations are aimed at the agency’s governance structure. CIRM has an unusually large and powerful board, known as the Independent Citizens Oversight Committee (ICOC). Proposition 71, the voter-approved legislation that created CIRM, stipulates 29 members, including leaders from research institutions and specific University of California campuses, all of whom stand to receive grants from CIRM.

The IOM report said the ICOC’s composition and duties should change. “Far too many board members represent organizations that receive CIRM funding or benefit from that funding,” the report states. These competing interests “compromise the perceived independence of the ICOC”.

Besides financial conflicts of interest, CIRM should consider conflicts on the basis of board members’ affliction with or personal advocacy of a particular disease. Moreover, no organization should be guaranteed a seat on the ICOC, and the board should be composed of “truly independent” members who can represent more diverse interests, including members of the business community.

The ICOC also recommended “separating operations from oversight”. The ICOC should have less authority over day-to-day operations at CIRM and instead focus on “strategic planning, overseeing financial performance, ensuring legal compliance, assessing the president’s performance, and devising a plan for preserving and expanding its considerable assets” after its funds from bond sales cease. No ICOC members should serve on various working groups, such as those that recommend how funds should be distributed.

The ICOC also gives final approval for every grant awarded.  On occasion, the ICOC has asked grant reviewers to reconsider their appraisals after rejected grant applicants appealed or petitioned their cases. This is a matter of serious concern, said Harold Shapiro, head of the IOM study panel, at a press conference today. “We think the extraordinary petitions really undermine the credibility of the organization.”  The petitions have already been controversial. Earlier this year, the LA Times described how a company won a multimillion-dollar award. After an appeal from Bob Klein,  former head of the ICOC, the board overruled recommendations from scientific reviewers.

The IOM panel said that CIRM’s recent funding awards that challenge recipients to begin clinical trials within four years were  “unrealistic”, and instead urged CIRM to focus on biological mechanisms underlying successful therapies and designing better ways to assess that a therapy was working.

The IOM also recommended creating an external scientific advisory board, most members of which should hail from outside California. The board would advise on funding the best science, picking discoveries to advance towards clinical trials and engaging industry to support drug development.

One way that CIRM discourages participation from industry is through its policies surrounding intellectual property, which are more extensive and less familiar than those used by the federal government, said Shapiro. But at least some of those policies are inherent in Proposition 71.

Finally, the IOM recommended that CIRM “develop a sustainability platform”, or a plan for its own future after its ten years of bond financing are over. Without more funding, CIRM is scheduled to make its last set of grant awards in 2017.

 

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