Recently, the Institute of Medicine (IOM) conducted a review of the California Stem Cell Agency, CIRM.
IOM has now released a quite lengthy report that makes a number of recommendations on various issues. You can also read a short summary here.
Unfortunately, I think that many of the IOM recommendations would be harmful to CIRM and California.
Interestingly, highlighting the extremely sensitive nature of this issue, while I’ve been talking with many bigwigs about this, at this point no one is wiling to go on the record with an opinion about it except one courageous soul, Don Reed (see his piece here).
What concerns me most about the IOM report as a stem cell scientist, educator, and patient advocate, is that paradoxically the IOM recommendations, if implemented, would actually make CIRM less effective and less responsive to patients and California citizens.
In particular, the IOM recommendation to reconstruct and take power away from the CIRM Governing Board (Independent Citizens Oversight Committee (ICOC)) seems likely to have extremely negative repercussions if implemented.
IOM failed to realize that it is the ICOC that not only most effectively represents California’s stakeholders, but also is most highly educated on the key issues of how CIRM can best advance stem cell research. The ICOC is therefore in the best position to oversee what CIRM funds. This oversight by the ICOC is of course guided by scientific review by the Grants Working Group.
IOM also makes the unrealistic argument that the best ICOC would be one that does not include any stakeholders because in the IOM’s way of thinking supposed conflicts of interest would be minimized or eliminated in this way. However, IOM itself admits there is no evidence that any conflicts of interest have ever guided ICOC decisions. Not one example.
Just as happens at NIH during the grants review process, at CIRM we need experts who are deeply invested in the issues to make decisions. If you eliminate University officials, patient advocates, and others from the ICOC (as IOM recommends)–those who deeply care about California, stem cells, patients, and fighting as well as curing diseases–I ask, who’s left?
Who would be on such a hypothetical IOM-approved ICOC board?
IOM provides no realistic guidance on this. In this way their report seems more like an ivory tower intellectual exercise than an operative, realistic guide to a dynamic agency that must operate in the real world.
In my opinion, if the IOM recommendations on the ICOC were taken, you’d be left with an ICOC full of people who are relatively detached from the regenerative medicine field and not as educated about stem cells and patients.
Finally, the idea that somehow CIRM can function properly with the ICOC (in whatever incarnation) hamstrung to only vote on all grants simultaneous for any given RFA with a “yes” or “no” for the whole group or proposals is deeply flawed. Such an ICOC would be dysfunctional.
The bottom line is that I believe CIRM should not make the IOM recommended changes to the ICOC.
The issue will come to a head on Wednesday, Jan. 23. It is an all-day workshop (10:30 a.m. to 6 p.m.) to consider the IOM study. To attend, come to the Claremont Hotel, 41 Tunnel Road, Berkeley, CA 94705. Or listen to the audiocast at (800) 700-7784. Participant Access Code: 279280. I hope to see you there!
Disclosure: I am a CIRM grantee
Paul,
Do you think COI have existed at the CIRM based on:
David Jensens Blog:
Steven Kessler, a scientific director at Advanced Cell Technology of Los Angeles, was not happy with the response he received from CIRM staff on a letter he wrote concerning what he said was a conflict of interest on the part of a unnamed reviewer.
According to the transcript of the meeting, here’s how Kessler summarized his position for CIRM directors:
“If a grant reviewer has a financial relationship with company “X”…that is, he’s receiving funding from that organization or he’s expecting royalty income from some company by virtue of having licensed technology to that company and that reviewer is sitting in on reviews from other for-profit organizations…and doesn’t recommend those for funding, to us, from a business perspective, that’s a conflict of interest.”
Kessler said he had cited “numerous instances” of conflicts on the part of the reviewer, where there would be “every incentive to help impede the competition for the company that he has a relationship with.”.
Kessler said,
“I was told that the way CIRM interprets its own conflict of interest policy, the example I gave you was not a conflict of interest.”
At that point CIRM Chairman Robert Klein cut off Kessler, declaring that the directors needed to discuss the names for CIRM-funded labs before going to lunch.
http://californiastemcellreport.blogspot.com/search?q=steven+kessler