Sunday, September 21, 2008

Text of Kessler's Conflict-of-Interest Comments

Steven Kessler, a research director with Advanced Cell Technology Inc., of Los Angeles, last month raised a question about a conflict of interest on the part of one unnamed CIRM scientific grant reviewer.

Kessler also addressed the issue of reviewer bias and proposed restrictions on the length of an appeal letter.

Here is the text of his remarks at the August CIRM directors meeting, including comments from CIRM Chairman Robert Klein.

Kessler:
"It's my understanding that for the new cell lines awards, that there were 58 proposals overall, that 12 came from for-profit organizations, none of those were recommended for funding, compared to presumably 18 of 38 from not-for-profit organizations. To me, that's clear evidence of bias.

"I've had – we formally appealed this on June 26th. The appeal -- I was the PI on one of them -- was two and a half pages describing for CIRM what a conflict of interest is from a business perspective, and another seven and a half pages specifically rebutting point by point all the reviewers' criticisms. I don't see how we can do this (in less length). We can certainly condense the letter, but what we did was cite the reviewers' comments and what our proposal actually stated that factually contradicted that. It would be more difficult, I think, for the board to understand what actually took place if we didn't do it in that type of a sequence.

"But just to come back to the conflict of interest issues, I've had discussions with CIRM staff just this week following up, citing CIRM's own conflict of interest policy to them on specific issues. One issue was:...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, companies 'A,' 'B' or 'C' and doesn't recommend those for funding. To us, from a business perspective, that's a conflict of interest.

"This is a bit different from the situation in academia where people quibble about technicalities on papers.... For-profit organizations...invest millions of dollars building up their patent estate because they won't proceed down the development path, which incurs...tens of millions of dollars in expenses, unless they have a clear patent path. So it is really a serious issue if...somebody, some reviewer with conflicts -- and we cited numerous instances (and) in our view there's no reason to recite those right now – where...a reviewer would have every incentive to help impede the competition for the company that he has a relationship with."
Klein:
"Well, I very much appreciate those comments. We do have an existing separate policy for conflicts. We treat them very seriously. We have a separate policy in place for re-review in the event of conflicts. And the staff does a thoughtful analysis. They have gone through and found a conflict in a particular -- potential -- even if they find a potential for a conflict, they look at potentially re-reviewing it. They're trying to err on the side of equity and justice here."
Kessler:
"I realize that. And 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. So -- "
Klein:
"Okay. So we'll have the opportunity between now and the next session to look at that as well, but we appreciate your comments. Thank you very much."
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