Monday, February 10, 2014

Amid Allegations of Unfairness, California's Stem Cell Agency Begins Examination of $40 Million Genomics Award Round

The California stem cell agency today said it has begun an examination of the grant review process in its $40 million genomics round, which has been criticized for irregularities, unfairness, score manipulation and the role of its president, Alan Trounson.

The agency confirmed the inquiry after the California Stem Cell Report asked last Thursday asked whether the board's counsel, James Harrison, was looking into the matter.

Kevin McCormack, senior director for CIRM communications, replied today in an email,
“There are always ways in which we can improve our performance, and we regularly review our processes to try and ensure we do a better job with each round of funding. We have been looking into the genomics award to identify areas where we can improve the process for future awards.” 
McCormack did not specifically respond to the question of Harrison's involvement. We have queried McCormack again about whether Harrison is involved. (McCormack subsequently confirmed Harrison's participation.)

Harrison, who is with Remcho Johansen and Purcell of San Leandro, Ca., has been outside counsel to the board since its inception. He drafted portions of Proposition 71, which created the $3 billion research effort in 2004. Harrison has expertise in conflict of interest and ethics issues as well as other related public policy matters.

Harrison's role at the agency exceeds that of a simple attorney. His length of service, knowledge and skills give him much wider influence.

CIRM's examination of the genomics round review followed complaints from rejected applicants and others about the process, which has been covered extensively by the California Stem Cell Report.

Trounson has come in for criticism in connection with the review and his subsequent recommendation in favor of the successful Stanford-led bid. One of the critics is Jeanne Loring, head of the stem cell program at the Scripps Research Institute and whose genomic application was rejected by Trounson and the CIRM staff. Her application and two others were recommended for funding by reviewers. Loring has contradicted Trounson's assertion that all applicants were given information that matching funds were part of the review criteria. Her application contained none. Stanford said it had $7 million.

Loring said that Trounson has interfered in CIRM's review processes in favor of Stanford. Trounson has been a guest at a Montana ranch owned by Irv Weissman, head of the Stanford stem cell program. Trounson did recuse himself in an earlier round involving an application linked to Weissman, but did not recuse himself in the genomics round.

Weissman was not listed in the latest Stanford application, but was in its original version. The associate director of Weissman's Stanford stem cell institute, Michael Clarke, was included in the final CIRM-approved version. Trounson lauded Clarke at the governing board's meeting last month in support of the Stanford project.
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  1. Anonymous4:14 PM

    Some attendees at the 2011 ISSCR meeting in Toronto were shocked to hear Trounson publicly talk about how much he enjoyed his rafting and flyfishing vacation with Weissman in Montana or Idaho. Was that on the same trip to Weissman's ranch?

  2. I suspect that is the case.

  3. Anonymous11:30 AM

    I guess this is how to get a rejection reversed:

    Date: October 22, 2009 From: Alan Trounson, PhD
    CIRM President
    To: Independent Citizen’s Oversight Committee Subject: Extraordinary Petition for Application DR1-01485
    Enclosed is a letter from Dr. Irving Weissman of Stanford University, an applicant for funding under RFA 09-01, CIRM Disease Team Research Awards. This letter was received at CIRM at least five working days prior to the October ICOC meeting, and we are forwarding it pursuant to the ICOC Policy Governing Extraordinary Petitions for ICOC Consideration of Applications for Funding.
    As required by that policy, I have reviewed the petition (referencing reviewer comments and the submitted application as necessary) in consultation with the CIRM scientific staff.
    The applicant addresses several reviewer criticisms related to the proposed rationale for the antibody therapeutic and asserts an inappropriate bias against the proposed mechanism of action.
    We appreciate Dr. Weissman’s arguments but upon careful examination of reviewer comments and discussion notes, we believe that reviewers addressed the RFA review criteria appropriately and that their comments were well justified. Although reviewers were very intrigued by the novel and potentially paradigm-shifting mechanism of action, they felt that the preliminary data presented in the application did not fully support a rationale for the proposed therapeutic and they had genuine concerns about whether the therapy would get through to the clinic.
    We believe that many of the issues raised by the applicant in this petition represent a scientific difference of opinion or reflect reviewer concerns that were not allayed by the data provided. For example, the applicant contends that a 2-fold difference in expression level of the CD47 antigen (between cancer cells and hematopoietic stem cells) is sufficient for an effective therapeutic window. Multiple, independent expert reviewers asserted this was not an adequate difference based on their own experience. The applicant also contends that observations from clinical experience indicate that macrophage activity in the target patient population will be adequate for the proposed therapy to succeed. However, no information directly addressing macrophage activity in AML patients was provided, and plans for such an assessment were not proposed. The applicant proposes the development of a possible bi-specific antibody but did not provide sufficient information about candidates for the second, targeted antigen (e.g. CD96) to enable reviewers to assess the potential value of this approach.

    The need to provide greater specificity by establishing a bi-specific antibody and duel antigen reactivity (CD47 and CD96) makes it challenging for commercialization and clinical application. Nevertheless, the data provided on animal response to the CD47 antibody is important, and efficacy in preclinical trials will be enabling despite the issues of relatively low differences in expression levels and the potential antigen sink that may exist.
    Reviewers expressed great confidence in this team of investigators but felt that the proposal was not sufficiently convincing to recommend an award at this time.
    This response provides an overall assessment by CIRM staff, based on our careful review of each of the points raised by the applicant. A point-by-point response would require reference to confidential or proprietary information. CIRM staff is prepared to provide that at the ICOC meeting, should a member so request.
    The enclosed letter represents the views of its author(s). CIRM assumes no responsibility for its accuracy.
    In addition, a copy of the CIRM Review Summary for this application is provided for reference.

  4. In the Weissman application mentioned here, he was successful in overturning the reviewers' rejection. Here is a link to a story from 2009 about the matter.

  5. Anonymous10:05 AM

    This from a different Anonymous. By the way- the links in your 2009 story no longer work.

    OK- let me get this straight.

    In a memo on October 22, 2009 to Irv Weissman, Alan Trounson recommended that Weissman's application be rejected.

    On October 27, 2009, the application was voted into the first tier- recommended for funding- by the oversight board. Either A. the board decided to ignore Alan's recommendation, or B. Trounson changed his mind during those 5 days.

    If A. The Board almost always rubber-stamps the recommend of CIRM/the president. Example is the Genome Center award, in which CIRM didn't even give the board any information except that they wanted Stanford, and the board- reluctantly, apparently- rubber stamped it.

    If B. Perhaps Alan changed his mind. One wonders if Trounson's warmer feelings toward Weissman had something to do with being invited to Irv Weissman's ranch for fly-fishing.

    1. Re Weissman and his 2009 disease team one application, plus the extraordinary petition/appeal process, the board almost invariably rubber stamps positive recommendations by its grant reviewers (the grant working group). Staff/Trounson recommendations are something new, less than a year old. The extraordinary petition process was in place in 2009, but it is now a dead letter and has been replaced by a new appeals procedure that shifts the primary responsibility away from the board.

      In 2009, Trounson was making a recommendation on Weissman's extraordinary petition/appeal concerning negative reviewer recommendations. Weissman's appeal was public at the time. Now such appeals are secret.

      As for the missing links, the agency has altered its Web site over the years and the links have not been maintained. Given the changing practices, it is now rather difficult to find the documents. But here are the current links with no guarantee that they will not change in the future. Trounson's letter and Weissman's appeal:
      Summary of the review of the Weissman application:
      List of all applications in the disease team round with scores:
      Link to transcript of board meeting with discussion of Weissman petition: