IOM Official Says CIRM’s Plan To Reduce Conflicts of Interest Falls Short
The California Institute of Regenerative Medicine's proposed guidelines to reduce conflicts of interest fall short of recommendations from the Institute of Medicine, according to the chair of an IOM committee that evaluated the agency, the Sacramento Bee reports (Craft, Sacramento Bee, 2/1).
Background
In 2004, California voters approved Proposition 71, which created CIRM. The agency was launched to advance development of stem cell-based disease treatments.
Prop. 71 required that CIRM's oversight board -- the Independent Citizens' Oversight Committee -- be composed mostly of representatives from:
- Biotechnology companies;
- Patient advocacy groups; and
- Research centers.
Since 2004, CIRM has allocated about $1.7 billion to 68 institutions to support advances in stem cell research and regenerative medicine.
In December 2012, IOM released a report stating that CIRM's original structure was useful for launching the initiative, but its overly centralized nature now makes it vulnerable to conflicts of interest.
IOM said that "far too many" CIRM board members are from organizations that could benefit from the research funds that the agency distributes, and therefore, the research agency should be restructured (California Healthline, 1/24).
Difference Between IOM Recommendations, CIRM Plan
The IOM report recommended that CIRM change the makeup of its board through legislative action or with a ballot measure presented to voters.
However, Jonathan Thomas -- chair of CIRM -- said that both strategies would take too long. He said, "I wanted to act decisively in a thoughtful, comprehensive and quick way," adding, "I wanted it to be said that we acted swiftly to put all these (conflict-of-interest) issues to bed and refocus attention on the groundbreaking research" (Sacramento Bee, 2/1).
CIRM's proposed guidelines call for:
- Voluntary abstention from voting on grants for the 13 members of the 29-member oversight committee who represent CIRM-funded research institutions;
- Restrictions on appeals made directly to the oversight committee by those denied funding; and
- More participation from biomedical companies to speed the transfer of research to clinical use.
CIRM said that it will decide in March whether to formally adopt the proposals (California Healthline, 1/24).
IOM Committee Chair Responds
In response to CIRM's proposed guidelines, Harold Shapiro -- chair of the IOM committee that evaluated the agency -- said, "There certainly is a gap between what we recommended and what they responded with." He added, "I wish they had moved closer to our recommendations."
Shapiro said he stands behind IOM's report. He said, "I think our recommendations sit together and interrelate to each other well," adding that "[i]t might have been helpful if [CIRM] indicated to us what they were willing to do and what they weren't."
He said that the agency should move quickly to make changes because it must develop a self-sustaining financial formula to replace its bond allocations by 2017 (Sacramento Bee, 2/1). This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.