California Stem Cell Research and a Super Doc: Inside a $4.4 Million Windpipe Grant at UC Davis

Paolo Macchiarini, Guardian photo 

Headlines around the world once hailed Paolo Macchiarini as a super-surgeon, a stem cell trailblazer who was responsible for the ground-breaking, first-ever stem cell-based trachea transplant.

It was good enough work, indeed, to be cited in 2013 as a starting point in a pitch by a team from the University of California, Davis, for $13 million from the $3 billion California stem cell agency. 

In their application, scientists Peter Balafsky and Alice Tarantal said they would build on the "first-in-human surgical successes with (the) stem cell-based tissue engineered airway implants" pioneered by Macchiarini

Last month, Macchiarini was fired from the prestigious Swedish Karolinska Institute. Six of eight of his patients have died. The institute said,

 "He has acted in a way that has had very tragic consequences for the people affected and their families."

The controversy has stirred up the international stem cell community with blog postings and sharp accusations. And in January, Vanity Fair carried an article that reported Macchiarini falsely claimed he was part of a “highly classified group of doctors from around the world who cater to the world’s VIPs,”including Pope Francis, Bill and Hillary Clinton, Emperor Akihito of Japan and President Obama.

The Italian doctor has denied the charges that led to his dismissal in Sweden and has been working in Russia.

The Macchiarini saga and its California connections offer a peek into the global nature of stem cell research and how scientists must rely on the integrity of others thousands of miles away --  as well as  the sometimes agonizingly slow search for cures. It also provides a deeper look at how the California stem cell agency goes about handing out money.

The California Stem Cell Report queried both Balafsky and Tarantal about their grant along with the California Institute for Regenerative Medicine (CIRM), as the stem cell agency is formally known.  

Kevin McCormack, senior director of communications, replied for CIRM. Asked whether the agency looked into the research by Belafsky as a result of the questions raised about Macchiarini, McCormack said,

"As with all the research we fund we have been carefully following the progress of Professor Belafsky’s project ensuring it continues to meet our rules and regulations."

Peter Belafsky, UCD photo

Belafsky, professor and director of the Voice and Swallowing Center at UC Davis, and Tarantal, professor in the Department of Pediatrics and Department of Cell Biology and Human Anatomy, said Macchiarini is not involved in the CIRM project. The point was stressed in boldface letters in their email response:

"Dr. Macchiarini has had no involvement in this project on any level, in any way, at any time."

(For the full text of the response, see here.)

Macchiarini was not always isolated from UC Davis and Belafsky. Macchiarini served on Belafsky's international team in 2010 when the Belafsky group performed the second-ever larynx transplant. The operation restored the voice of a Modesto, Ca., woman who had been unable to speak for a decade. 

UC Davis issued a press release saying Macchiarini served as an advisor and assisted in the surgery. The statement also said that Martin Birchall of the United Kingdom, a co-leader with Macchiarini on his ground-breaking 2008 transplant surgery, served as a scientific advisor and assisted with the California larynx surgery.

Birchall was identified as a collaborator on the CIRM grant that was approved for Belafsky and Tarantal.  A press release from University College London said that the work in Davis would serve as a "fundamental under-pinning" for two clinical trials in the United Kingdom.

Birchall received a $19,800 planning grant in 2011 to prepare an application for research that appears to be aligned with the current work at UC Davis. Birchall was listed by CIRM at the time as a researcher at the California campus.

Belafsky and Tarantal told the California Stem Cell Report that Birchall is no longer involved with their work. They said,

"Dr. Birchall was involved in our project at the onset, but due to the logistical difficulties of intercontinental collaboration, is not currently an active participant."

The Belafsky/Tarantal application originally sought $13.3 million. It was trimmed to $4.4 million on the recommendation of the agency's then president, Alan Trounson, who apparently agreed with reviewers that the initial scope and budget were high, but still recommended funding.

The application was given a score of 70 on a scale of 100 by agency's blue-ribbon scientific reviewers, all of whom came from out-of-state. As is their usual practice, the reviewers met behind closed doors and voted on the application. The action then went to the CIRM governing board, which has almost never rejected a favorable decision by its reviewers, whose economic and professional interests are not disclosed publicly.

The score of 70 placed the proposal just below the cutoff line of 75 for routine approval by the board, but the reviewers did not nix application.

The agency publishes a summary of reviewer comments, which does not identify applicants or their collaborators. The summary on the UC Davis application said the research "presents a unique opportunity to bring a world-leading regenerative medicine technology to California." The summary additionally said, without elaboration, "It was also noted that this project is unlikely to be funded by other agencies."

The summary said,

"Reviewers agreed that having already treated human patients (such as those involved with Macchiarini) using this approach is strong proof of concept(for Belafsky's work)."

Reviewers noted that "manufacturing and testing methods were not well described" but "the UK-based collaborators (Barchall and his group) will clearly play an important role in helping to establish the manufacturing process."

The summary added,

"Reviewers were unclear on the relationship between the California- and UK-based team members and whether the relationship and efforts were collaborative or duplicative."

Belafsky appeared before CIRM directors in Los Angeles in December 2013 to ask them to approve his research, saying good treatments for "complex breathing and swallowing problems" do not exist. With little debate, the board voted 8-0 to approve the award.

CIRM's McCormack said that the agency has paid out $3.3 million of the $4.4 million grant. He said, 

"Dr. Macchiarini has never been a part of the UC Davis project or any work that CIRM has funded.... The primary aim of the CIRM project is to determine the scientific reproducibility of research results from previously published studies regarding tissue-engineering for severe airway stenosis. The results are pending."

Belafsky said in his email,

"The translation of high-risk, complex innovation from the laboratory to suffering patient is not an easy road. The controversy surrounding Macchiarini has resulted in the redoubling of our efforts to explore the science behind what saves lives and what does not. This step is essential in order to lay a firm, evidence-based foundation upon which to build.

"Since your primary focus relates to the work of Macchiarini, I would like to re-emphasize that our project is fundamentally different. Our research is focusing on decellularized trachea only, whereas he has utilized synthetic grafts."

Belafsky continued,

"This is a work in progress, and we do not yet have the data to answer all the questions raised by the scientific community. We may apply to CIRM for funds to continue our research, but will not consider human implantation until we are satisfied that the science is sound and the technology is safe."

Law Firm Memo on Trounson Investigation

Here is the memo provided by Remcho, Johansen & Purcell concerning its limited investigation of Alan Trounson and his contact during May and June with StemCells, Inc. It contains additional details and the names of persons interviewed.

 Here is one paragraph that deals with what CIRM might have done had they known Trounson was in contact with the firm concerning employment. The full text follows.

“Dr. Trounson contacted Martin McGlynn, SCI’s President and Chief Executive Officer, on May 1, 2014 to set up a meeting to discuss his future plans. Based on a calendar entry, it appears that Dr. Trounson and Mr. McGlynn met on June 4, 2014. On June 9, 2014, SCI offered Dr. Trounson a seat on SCI’s Board of Directors, subject to the Board’s approval. SCI made the appointment on July 7, 2014. Had SCI notified CIRM at the time of its offer to Dr. Trounson, CIRM would have taken steps to wall Dr. Trounson off from any involvement in decisions relating to SCI.”

  Remcho Memo on Trounson Investigation by DavidJensen

StemCells, Inc., Says Patient Endangerment Charges Lack Merit

StemCells, Inc., said late today that charges that is endangering patients in clinical trials have no merit and that the company’s primary concern is the safety of its patients.

The Newark, Ca., company was responding to a lawsuit filed earlier this week that alleges the firm is manufacturing human cells in a process that puts “patients at risk of infection or death.”

The suit was filed by Rob Williams, a former senior manager at the publicly traded company. Williams said he was unlawfully fired by StemCells, Inc., after bringing the stem cell quality issues to the attention of senior management.

Earlier today, the California Stem Cell Report asked the company for comment. Ken Stratton, general counsel, responded. Here is the text of his reply.

“As you know, StemCells, Inc. is engaged in the research and development of cell-based therapeutics and is currently sponsoring clinical studies of potential therapies for spinal cord injury, AMD and pediatric neurological disorders as well as conducting pre-clinical studies in Alzheimer’s disease.  The pre-clinical AD studies, but none of the clinical studies, are partly funded by CIRM.

“The Company has reviewed the complaint filed by Mr. Williams, a former employee whose employment was terminated for performance deficiencies, and finds no merit to the allegations. The Company has retained Littler Mendelson as its litigation counsel and intends to defend itself vigorously in court.

“You should know, the elements of manufacturing practices that concerned Mr. Williams were immediately and carefully reviewed by the Company.  The Company’s primary concern has always been, and will continue to be, the safety and tolerability of stem cell transplantation in its clinical trials. Over the years, we have consulted with multiple experts in the field and we believe our processes, procedures and controls, as fully described in our regulatory filings, are appropriate for a company at our early stage of clinical development and comport with applicable guidelines and regulations.  To date, no patients participating in the Company’s clinical studies have experienced any product related safety concerns.

“We hope you find this information helpful.”

California Stem Cell Agency Examining Lawsuit Alleging Patient Endangerment and 'False Certification'

The California stem cell agency today said it is reviewing a lawsuit involving the recipient of a $19.4 million award that alleges the firm is manufacturing human cells in a process that puts “patients at risk of infection or death.”

The most serious allegations against StemCells, Inc., of Newark, Ca., involve its clinical trials. The stem cell agency’s $19.4 million research award to StemCells, Inc., does not involve human beings, only initial development of a possible therapy for Alzheimer’s over the next three years. Both the clinical trials and the Alzheimer’s research use the same proprietary cells, HuCNS-SC.

The company said in a 2013 press release,

"We know from the preclinical work that our proprietary HuCNS-SC cells survive in the toxic environment of the Alzheimer's disease brain and restore memory under the regulation of the host." 

The lawsuit was filed by a former senior manager, Rob Williams, of the publicly traded StemCells, Inc. He alleged he was fired after complaining about the cell problem to senior management.

In addition to possible injury, the lawsuit said that “the use of adulterated stem cells lots could skew patient test results, effectively jeopardizing data behind years of clinical trials and research.”  

The lawsuit said that StemCells, Inc., receives

“…millions of dollars in government funding, including grants from the California Institute for Regenerative Medicine (CIRM). As part of certifications that Defendants made and, on information and belief, continue to make, to the State of California in order to obtain such funding, Defendants represent that their manufacturing processes yield stem cells that are ‘safe for human stem cell transplantation.’ Additionally, in order to secure CIRM funding, Defendants represented and represent that the company follows current Good Manufacturing Practices (cGMPs) promulgated by the U.S. Food and Drug Administration (FDA), a set of standards designed to protect the public from dangers to consumer/patient health and safety. Plaintiffs protected activity, as described above, included efforts to stop, complaints about and refusal to engage in or cover up violations of these standards, and by extension the false certifications submitted to the government, certifications that the company used and uses in order to secure substantial funding.”

The lawsuit also alleged that StemCells, Inc., violated FDA standards and provided false information to the FDA, which has not yet responded to queries from the California Stem Cell Report.

In response to a query, Kevin McCormack, spokesman for the $3 billion stem cell agency, said the agency was carefully reviewing the lawsuit.

Williams attorney, Daniel Velton, has not responded to queries about whether he or Williams informed the FDA of the issues raised in the lawsuit.

StemCells, Inc., did not respond to queries about the matter. (Late yesterday, the firm said the allegations have no merit. See full text here.)

The company was founded by Stanford researcher, Irv Weissman, who sits on its board and is chairman of its scientific advisory board. His wife, Ann Tsukamoto, is executive vice president. Last week the stem cell agency announced that it was conducting a full review of its activities with the firm after it appointed the agency's former president, Alan Trounson, to its board seven days after he left the agency. 

Here is a copy of the lawsuit, which was first reported by Elizabeth Warmerdam of Courthouse News Service.

California Lawsuit Charges StemCells, Inc., with Putting Patients at Risk

A former senior manager at StemCells, Inc., which holds a $19.4 million award from the California stem cell agency, has filed a lawsuit alleging that “deficiencies in the company's cell lines put patients at risk of infection or death during clinical trials.”

The charges were contained in a suit by Rob Williams in Alameda County court, according to an article on Courthouse News Service written by Elizabeth Warmerdam. Williams is suing for wrongful termination, retaliation and violation of the California False Claims Act.

According to the article, the complaint said that StemCells, Inc., of Newark, Ca., says its stem cells are safe for human transplantation.  Warmerdam continued,

“Williams says he was hired as the company's senior manager of manufacturing in December 2013 to oversee its manufacturing facility, where stem cell cultures are cultivated for use in clinical trials.

“'Shortly after beginning his employment, plaintiff noted poor sterile technique, failure to adhere to current Good Manufacturing Practices in the company's manufacturing process, and substantial deficiencies in the company's Manual Aseptic Processing of HuCNS-SC (Human Central Nervous System Stem Cells) cell lines - failure and deficiencies that put patients at risk of infection or death during ongoing clinical trials,’ Williams says.

“Williams claims he also saw manufacturing deviations during cryopreservation of Working Cell Bank lots, leading to numerous stem cell lots with dangerously high numbers of damaged cells.

“'Knowing that these cells were to be injected into human patients, and that the high level of damaged cells and the possibility of contaminating microorganisms could cause serious harm to patients, plaintiff immediately took his concerns to upper management. He also noted that the use of adulterated stem cells lots could skew patient test results, effectively jeopardizing data behind years of clinical trials and research,’ the complaint states."

It was not immediately clear whether Williams’ allegations directly involve the work being funded by the California stem cell agency(see here, here and here), which has been asked for comment on the lawsuit.  The California Stem Cell Report has also asked the publicly traded company for a comment, although the article said the firm did not respond to a query by Courthouse News Service.

 (Late yesterday, the firm said the allegations have no merit. See full text here.)

The lawsuit said that Williams was told to conceal his finding from unspecified reports and that he was suspended shortly thereafter. It said that he sent emails to upper level management about his concerns and that he was fired a few weeks later.

Williams’ Linked In profile said that he has 15 years industry experience, including nearly six years as a senior manager at Alvine Pharmaceuticals and three at Johnson&Johnson.

Williams is seeking unspecified punitive damages from StemCells, Inc.

Courthouse News Service is a Pasadena-based national news service for lawyers and the news media.

Researcher Alert: California Stem Cell Agency Tightening Budget Oversight on Grants

Some of California's top stem cell researchers are going to have to sharpen their spreadsheets if they want to win money from the state's $3 billion stem cell agency.

The agency is moving to beef up scrutiny of the high-profile, big-ticket grant applications that it will consider during the next several years. The effort may well extend to all grant programs. The move also makes it clear to researchers that the CIRM staff is in the driver's seat when it comes to budgeting on research projects.

The plan was laid out this week in a memo to directors of the California Institute for Regenerative Medicine (CIRM) by Ellen Feigal, the agency's senior vice president for research and development. She said,

“Increasing the importance of budgetary review will encourage applicants to propose rigorous, realistic and vetted budgets, and will further our mission to be good stewards of taxpayer dollars. These additions will not significantly increase the workload burden on GWG members (grant reviewers) and explicitly acknowledge that program goals, scientific plans, accurate budgeting and prudent spending are inextricably linked.”

The proposal comes before the CIRM directors' Science Subcommittee next Monday and would alter the closed-door grant review process in the following manner, according to Feigal's memo.

• “To assist GWG review, appropriate expertise on budget and financial matters (e.g., this could be in the form of a specialist reviewer, or can also be assigned to a GWG reviewer with the appropriate background and expertise), will review applications for sound budgeting and provide comments or questions to the GWG for consideration by the reviewers before the reviewer’s final scores are entered.
• “If the financial/budgetary matter potentially directly impacts on the design or feasibility of conducting the project, the GWG may consider this issue in the scoring; otherwise, budgetary and financial issues and questions will not contribute to the scientific score.
• “As appropriate, review summaries sent to the ICOC (the CIRM governing board) will identify scientific as well as budget or other issues. To the extent endorsed by the GWG, the review summaries will also identify potential resolution should the ICOC approve a given award with budget issues.
• “CIRM officers should be provided explicit discretion to consider the budget comments, as well as budget or other issues. To the extent endorsed by the GWG, the review summaries will also identify potential resolution should the ICOC approve a given award with budget issues.”

Feigal's memo clearly indicates that CIRM staff has experienced push-back from recalcitrant researchers when efforts have been made to bring costs under control. She noted that the agency's staff examines a research project's budget during the “prefunding” review that follows board approval. However, Feigal said, at that stage, “It is often challenging to make substantive changes to the budget, based on appropriateness of study activities and costs, given the ICOC approval at a given budget amount.”

The agency has already examined some budgets prior to board approval. One grant review in a $200 million-plus round this summer, for example, declared that costs to prepare regulation packages had “overlap” and were “excessive,” along with costs dealing with manufacturing and per patient expenses. That was for a high-scoring application by Antoni Ribas of UCLA, and he was not alone.

In her memo, Feigal listed other cases of budgetary shortcomings in recent applications:,

• “Budget does not align with the program deliverables and milestones. For example, the budget includes activities not relevant to project objective(s) or that are out of scope.
•”Budget does not contain adequate expenses for known costs. For example, an applicant may budget $100,000 for a GMP manufacturing run of a biologic in which it is generally accepted knowledge that the actual expenses are typically much greater.
•“Budget item significantly exceeds a known cost or seems excessive without adequate justification. For example, an applicant may propose a surgical expense of $100,000 per patient for a procedure with Medicare reimbursement set at $15,000.
•“Cost allocations are not done properly. For example, an applicant is developing the same therapeutic candidate for 3 indications, and is applying for CIRM funding for 1 of the 3, but is charging CIRM for the cost of the entire manufacturing run.”

Initially, the budgetary review would be used in disease team, early translational, strategic partnership rounds, and any new rounds “as deemed appropriate.” Feigal said, however, that “all applications for CIRM awards should be carefully examined for budgetary appropriateness.”

Our take: This seems to be a well-advised move, albeit one that is not likely to find favor with researchers accustomed to loose oversight. It moves budgetary review to an earlier stage and gives the CIRM directors a chance to weigh in on those matters prior to approval of grants, instead of creating a sense of entitlement on the part of recipients that may pop up following board approval of their applications. Indeed, the plan makes such good sense that it raises the question why it was not in place years ago.

A final note: Feigal's memo is an excellent example of the type of information that clarifies issues and helps CIRM directors make the best possible decisions. It provides some history, good evidence for a change and an explanation of benefits. Additionally, the memo is timely, having been posted on the CIRM website sufficiently in advance of next week's meeting to give affected parties and others time to comment and make constructive suggestions. The memo is also far superior to the Power Point presentations that are often submitted to the board minus any nuanced, written discussion of the issue at hand.

Next week's meeting will be based in San Francisco but also has teleconference locations in Irvine (2), La Jolla, Stanford, Pleasanton, Oakland and Los Angeles where the public and researchers can participate. The specific addresses can be found on the agenda.

CIRM Approves $300,000 More for Tech Help, Including Grant Management

The Governance Subcommittee of the California stem cell agency yesterday approved spending an additional $300,000 for technology assistance as it wrestles with its $1.2 million – and growing – grants management system.

A $100,000 increase was okayed for Turner Consulting Group of Washington, D.C., and a $200,000 extension for 25by7 of Santa Monica, Ca., according to a CIRM spokesman. Turner began work August 2008 on the grants management system under a $120,000 contract. Increases were approved last February and September. With the latest increase, the value of the two-year contract now stands at $350,000. Turner's contract is scheduled to end next June but may well be extended.

25by7's original $175,000 contract for network, server and desktop support began one year ago. Under the action yesterday, the contract was extended for one year, bringing its two year total to $375,000.

CIRM expects to seek additional information technology help next year.

The directors subcommittee also heard a report on the system designed to oversee $3 billion in grants and loans. It was first public accounting of how much has been spent on the grant management system, which CIRM has described as "a risk." No details were available concerning directors' comments.

New Figures Show CIRM Spending $1.2 Million-plus for Grant Management

In its first-ever public accounting of spending for its grant management system, the California stem cell agency this week disclosed it has already laid out more than $1.2 million, with substantially greater expenditures to come in the near future.

Overseeing CIRM's largess is no small task. The agency has approved 320 grants and one loan worth more than $1 billion. It is expected to approve another $2 billion over the next five or so years – more if it can secure funding beyond its current bonding authorization of $3 billion.

The amount CIRM is spending for grant management, not including state staff time, is tiny compared to the total portfolio. However, grant management is critical for the agency, which labelled the task as a “risk” as recently as last June.

In a new staff report prepared for a meeting Wednesday of the CIRM directors' Governance Subcommittee, the agency said it has made “considerable headway” since last spring. But CIRM said additional work will be needed, including a decision on whether to buy additional software or develop it in-house with the use of more consultants.

More immediately, the staff asked directors for approval of an additional $300,000 for technology assistance, extending and expanding two existing contracts with Turner Consulting of Washington, D.C., and 25by7 of Santa Monica, Ca. Some of the increases will cover costs in addition to grant management.

CIRM did not offer a total for past grant management spending in the documents it prepared for its directors. Nor did it predict the ultimate cost. The California Stem Cell Report compiled the $1.2 million figure from two new documents on the CIRM Web site. The first was a report on grants managements expenditures through June 30, 2009. The second was a report on all spending on outside contracts through Sept. 30, 2009, including additional funds for grant management.

The report on grant management is the most complete explanation of the status of the system, which was supposed to cost no more than $757,000, directors were told in October of 2007. But by spring of 2008, CIRM began hiring outside consultants to deal with the issue.

The contract at that time involved Grantium of Ottowa, Canda. CIRM staff said.

“However, that effort failed because CIRM's needs continued to evolve rapidly beyond the original scope, so the two parties mutual agreed to terminate the contract in 2009.”

CIRM cannot solve its technology issues in-house because Prop. 71, written by CIRM Chairman Robert Klein and others, capped the CIRM staff at 50 employees. The grant report said that “it has long been clear” that the agency faced critical problems because of the hiring cap.

Currently, 48 percent of CIRM's staff (20 out of the current 42 employees) is involved “centrally in some part of the grant life-cycle,” which includes everything from applications to standards enforcement,

The agency, however, does not have a single information technology staff person dedicated to grants management, according to its report. It had one in 2005-6, but he resigned. Currently CIRM has five grant management officers compared to one in 2006-7.

CIRM staff began “compliance site visits” in 2008-9 when it had 295 grants awarded, completing eight visits that fiscal year. CIRM expects to see 230 progress reports from grant recipients during the current fiscal year, compared to 16 in 2006-7.

CIRM posted the reports on the grant management system and the contract extensions on its Web site last Wednesday. The public can participate in next Wednesday's Governance meeting at teleconference locations in San Francisco, Palo Alto, Los Angeles(2), Stanford, Irvine and La Jolla. Specific addresses can be found on the agenda.

The item below contains additional links to additional information concerning CIRM grant management.

CIRM Grant Management Info and Costs

Here is a rundown on key documents related to CIRM's $1.2 million-plus expenditures on its grant management system.

Articles from the California Stem Cell Report

Cost Overruns and Candor from CIRM – May 29, 2008

Vagueness in CIRM budget, June 2009, with some info on the system:“The budget does not appear to contain a straight-forward accounting of all the past costs associated with the Grantium program or the projected cost of the new system. It appears to be something in the neighborhood of $610,000.”

CIRM's Troubled Grant Management System: A $1 Billion Oversight Matter – July 13, 2009

CIRM Grant Oversight Receives $150,000 Boost – July 22, 2009

California Courts and CIRM: Both Troubled by Technology Problems – Oct. 25, 2009

CIRM Documents

Transcript, CIRM directors meeting, October 2007, during which CIRM staff said the cost would not exceed $757,000

CIRM document describing grant management system as a risk – June 2009

First public accounting of CIRM expenditures on grant management system, November 2009

Buying BMWs and Grant Oversight

Revocation of three grants by the California stem cell agency has sparked a modest exchange of comments on TheScientist.com Web site.

Jef Akst wrote, on Nov. 16, about CIRM's grant oversight in an article headlined, “When does oversight overstep?”

Here is a sample from two comments.

Terry Iorns:

“I agree with others in the areas of be able to pursue serendipity and whether proper terms of oversight were apparent to the researcher, but I don't think getting the grant is a blank check to do any kind of research.

“I see no difference in using the funds to pursue unrelated research and using the funds to buy a BMW.”

Anand Rajan KD:

“'Taxpayer money' is just an euphemism for people to poke their nose into what is not their business in the first place. If at all - like the previous poster noted - there can be financial administrative oversight. You can look out for any scientist buying a BMW with his grant money, but if he is doing experiments with the money you gave him, where is the problem?”

Some Question CIRM Grant Oversight as Excessive

The California stem cell agency is receiving “mixed reviews” for its oversight of its research grants, which now total $1 billion, according to an article today in The Scientist magazine.

Commonly governmental agencies are chastised for failing to ensure that taxpayer funds are spent effectively. In this case, the stem cell agency is being faulted -- by some -- for being too tough.

The case in point is the termination -- first reported by the California Stem Cell Report -- of three out of more than 300 grants. The amounts are tiny compared to the $3 billion that CIRM expects to give away, accounting for only $1.8 million in a $46 million round approved in 2007.

The Scientist article by Jef Akst said,

“Clearly, funding agencies need to offer some oversight of grants to avoid misuse of funds. But can there be too much of a good thing? “

She continued,

“There are mixed reviews among the scientific community about whether CIRM's close watch of their grantees is a good thing. To some, it is an important practice for public funding agencies such as CIRM to show the taxpayers that their money is going towards productive and fruitful research. 'I think the oversight is outstanding,' said John Simpson, the stem cell project director at the advocacy group Consumer Watchdog in California. 'It shows that they're not asleep at the switch. CIRM is functioning as both a grant making agency [and] also something of a steward of the funds it hands out.'

“But others say this kind of intense supervision can burden investigators -- and the science itself. 'In theory, it's a terrific thing,' agreed David Kaplan of Case Western Reserve University in Ohio, who has written about the peer review system at NIH. "To have the granting agency being involved enough to be helpful to their grantees, I think that is a terrific idea. The problem with that kind of a system is that you can be too intrusive. That eliminates that kind of serendipity [in scientific discovery].'“

Akst wrote that CIRM's “short timeline” may lie behind its grant monitoring, which is more rigorous than performed by the NIH.

She said,

“While the NIH will exist for many years to come, CIRM has a 10-year lifespan, as approved by California voters in 2004. 'CIRM has very defined goals,' said the Burnham Institute for Medical Research's Huei-Sheng Vincent Chen, another SEED grant recipient. '[They] wanted something within 10 years so they have to be more aggressive.'"

The Scientist magazine also chose to publish the names of the scientists whose grants were terminated. Their names are by law public record. Only one of the three scientists spoke with Akst, John Cooke of Stanford.

Akst's story said,

"'I anticipated that they would be happy with that [new] proposal,' Cooke recalled. 'But] they weren't happy.' In January 2009, after a second, more detailed progress report, follow up phone discussions, and a petition for reconsideration from Cooke, CIRM revoked his second year of funding -- nearly half of what he had originally been awarded -- citing the new directions his research had taken.

'I can understand their reasoning,' Cooke said. 'I just wish I had understood that that applied to the SEED grants.'"

Last month, CIRM approved $230 million for 14 grants up to $20 million each that appear to require even more rigorous oversight than earlier rounds. Some CIRM directors said publicly that they expect to see some of the latest grants terminated early because they will fail to meet the required benchmarks.

You can find a list here of all the items published on the California Stem Cell Report concerning the terminated grants. They include comments from the other two scientists, who we have chosen not to identify for previously discussed reasons.

Rundown on Grant Termination Stories

Our grant termination story last week is continuing to draw readers. However, other stories were carried as far back as last April. Here is a complete list of articles on the subject.

April 24, 2009
CIRM: Some Scientists' Grants to be Pulled
Some researchers who have been funded by California's $3 billion stem cell agency are going to lose their grants because of a lack of progress, according to a top CIRM official.

June 14, 2009
CIRM Pulls a Grant, Aggressive Monitoring Reported
In what appears to be a first, the California stem cell agency has pulled at least one grant from one of its researchers, apparently because of a lack of progress.

June 17, 2009
CIRM Pulls Three Grants from Researchers
SAN DIEGO -- The California stem cell agency tonight said it has terminated three research grants for lack of progress, but declined to release immediately the names of the researchers or the institutions involved.

Nov. 2, 2009
CIRM Scrutinizes Grantee Performance: The Tale of Three Terminations
Playing the rich uncle to California stem cell researchers is unquestionably satisfying, but the folks at the state's $3 billion stem cell agency sometimes bear messages for scientists that may be less than warmly received.

Text of Csete's Description of CIRM Grant Monitoring

CSCR Withholds Names of Terminated Grantees to Avoid Unnecessary Harm
The California Stem Cell Report is not naming the three scientists whose grants were terminated by the state's stem cell agency because doing so would unnecessarily damage their reputations.

CIRM as Regulator, Compliance Enforcer
In addition to handing out $3 billion in grants to California stem cell researchers, CIRM is also a regulator, monitoring the conduct of its grantees' research to ensure they adhere to the agency's stringent ethical standards.

Nov. 5, 2009
More on the Tale of Three Terminations
Some confusion has arisen in connection with a story in the Scientist magazine concerning our account of the termination of three grants by the California stem cell agency. In an attempt to clarify the situation, we are providing more information on the decision by the California Stem Cell Report to withhold the names of the researchers and also on the actions of the California stem cell agency.

More on the Tale of Three Terminations

Some confusion has arisen in connection with a story in the Scientist magazine concerning our account of the termination of three grants by the California stem cell agency.

In an attempt to clarify the situation, we are providing more information on the decision by the California Stem Cell Report to withhold the names of the researchers and also on the actions of the California stem cell agency.

CIRM was slow to release the information, which by state law is public record, but the agency did not withhold it. Here is the string of events.

Last June, I was at the CIRM board meeting at which Marie Csete , then CIRM's chief scientific officer, gave her account of how the CIRM SEED grants were monitored. (CSCR carried the text of her remarks and those of directors in the four related items posted this week.)

At the meeting, I asked both the CIRM attorney, James Harrison, and the chief communications officer, Don Gibbons, for the names. They asked for a week or so delay in providing them in order to be sure the researchers had been told their names were public record and to discuss the matter with CIRM's executive committee. Given the potential impact on the researchers, that seemed appropriate.

Some weeks passed, and I still had not heard back. So I queried Gibbons by email concerning the names. He ultimately provided information that led to their identification.

Over the decades that I have spent as a reporter and editor, my practice then and now is to publish the names of individuals involved in public matters. In the case of CIRM, the agency leads an unprecedented, $6 billion (including interest) experiment with taxpayer dollars that could have a major impact on science, making it all the more important that the agency be critically examined.

That said, it is incumbent on journalists to consider the personal and professional impact of the publication of names on the individuals involved, many of whom are secondary to the matter at hand. In marginal cases, editors and reporters should weigh the pros and cons of such publication and whether the potential damage outweighs the possible public good. In this case, some of the questions for me were: Will better policy result if the individuals are identified? Was there wrongdoing? Is it unfair to single out these individuals while others who may be involved in more serious misdeeds (say for example, possibly some NIH grant recipients) remain anonymous?

Given current practices surrounding government research grants, public disclosure of the names in this case would carry a great potential for harm to the individuals and little public benefit. The problem is largely created by NIH grant monitoring practices, among others. As I understand it, the NIH rarely, if ever terminates a grant for lack of progress. When NIH grants are terminated, they appear to involve cases of malfeasance or some sort of wrongdoing. Such does not appear to be the case involving the three CIRM grants. However, the perception in the scientific community, right or wrong, is certain to be colored by the NIH approach. I also think it is fair to say that many CIRM researchers are not accustomed to CIRM's monitoring, particularly the three researchers, all of whom have long and respected careers.

Probably the most important question raised by this case is: Why does the NIH give away money and not monitor the grant progress much as CIRM does? CIRM Director Floyd Bloom, former editor-in-chief of Science magazine, said that under NIH practices a researcher is free to "change directions, convert personnel into equipment funds, and essentially re-program the proposed project." It may be stretching it a bit, but some folks from Enron and WorldCom are serving prison time for doing much the same thing.

As for CIRM's openness and transparency, given decades of experience with California state government, it is not much different than many state agencies, which is not a high hurdle. CIRM certainly could do better, especially considering the conflicts of interest that are built into its board.

The agency has pledged to adhere to the highest standards of openness but has fallen short of that measure, which goes beyond mere legal requirements. For example, CIRM's 29 directors and additional top management must file statements of economic interest under the state's conflict of interest laws. The governor of the state of California posts his statement online along with the top officials in his administration. CIRM does not meet that standard. Instead, interested parties must make a specific request for a public record that is not on the CIRM Web site. Responses on records requests sometimes take weeks and weeks. CIRM refuses to disclose in any form the economic interest reports from the reviewers who make the de facto decisions on grant applications. That makes it all but impossible for grant applicants or the public to determine if conflicts exist. CIRM also regularly fails to post important background material well in advance of its directors meeting, meaning that interested parties do not have enough time to comment intelligently or make plans to attend the meetings. More examples could be cited.

The Scientist story has generated little comment on its Web site, but one remark caught my eye today. Rafaela Canete-Soler said,

“The (monitoring and termination) policy at the CIRM seems to me timely and appropriate. By the tone of the article and the sentiments of the researchers, I can only express my admiration for them, as well as for CIRM and the way the evaluation seems to have taken place. We all know that projects and ideas do not always work the way that we had planned.

“I once heard that changes for the best almost always happen first in California, then in the United States and then in the rest of the world. The policy of NIH of liberty to take the research where it leads you does not appear to be sustainable any longer. For a very simple reason: resources are finite. Priorities and objectives, particularly those proposed by researcher, and for which they are funded, are to be followed up and nurtured within the framework of a sound and healthy competition system.”

Scientist Magazine Picks Up Grant Termination Story

The Scientist magazine today picked up our report on the termination of three grants by the California stem cell agency.

In a piece by Jef Akst, the magazine said CIRM “giveth and it taketh away.”

The Scientist piece, which credited the California Stem Cell Report, did not add a great deal to our report, but Akst wrote,

"'Termination is a last option,'" CIRM's chief communications officer Don Gibbons wrote in an email to The Scientist. 'We first work with grantees who are not progressing to get them back on track.'"

CIRM Scrutinizes Grantee Performance: The Tale of Three Terminations

Playing the rich uncle to California stem cell researchers is unquestionably satisfying, but the folks at the state's $3 billion stem cell agency sometimes bear messages for scientists that may be less than warmly received.

That's when they become regulators and stewards of the public's money. Particularly when they exercise that responsibility in a more rigorous way than is the practice at the NIH.

CIRM is not making much of the fact that it has revoked three grants because of a lack of progress. It took us more than a month to secure the identities of the researchers who fell under CIRM's scrutiny. The agency, however, should take pride in its oversight. It enhances the credibility of the $3 billion agency and serves notice to all grantees that CIRM is more than a sugar daddy and takes its responsibilities seriously.

Only four months ago, CIRM directors heard a report on monitoring of grants that merits attention following approval of the largest research grant round in the agency's five-year history. The $230 million in disease team grants pose special challenges for the tiny agency. Its staff, currently without a chief scientific officer, will be called on to make go, no-go decisions on continued funding as researchers hit or miss bench marks in projects involving as much as $20 million.

One can only imagine the ruckus if CIRM staff recommends that funding be halted on a $20 million, four-year grant involving such high-profile and respected institutions as UC San Francisco, UCLA, Stanford, Salk and City of Hope, among others.

CIRM opened the window a bit on its oversight of grants at the board meeting in San Diego last June. Marie Csete, then chief scientific officer for CIRM, described in a positive fashion her office's monitoring of the $45 million SEED program, the first ever research grants by CIRM. She said CIRM's efforts saved some grants that would have perished. But it took a question from director Ricardo Azziz, chairman of the Department of Obstetrics and Gynecology at Cedars-Sinai Medicial Center, to bring out the information that three grants had been terminated.

As for the issues raised during the monitoring, Csete said,

“In general, I have to say it was slow progress. It wasn't bad progress. And it allowed us to identify some issues that are, I think, endemic with a new agency and new ideas. Institutions had trouble getting lines for their investigators. People had trouble hiring post docs who were able to do the work. We had trouble getting some of the (grants) out the door for various reasons.”

CIRM director Floyd Bloom, former editor of Science magazine and executive director, science communication, at Scripps, praised Csete and her staff's work. He said,

“This kind of nurturing, interactive relationship with the PIs's is absolutely unique in the grant world. And so I think it's a wonderful thing that you've instituted. It's going to be a tremendous amount of additional work on your staff to be able to do that, but it's highly commendable, and it's going to make the difference between success or failure, particularly for these intermediate level of successful early experiments where they have to be encouraged to go on and push.”

We spoke by telephone with two scientists whose grants were revoked and exchanged email with the third, who was out of the country. None are particularly pleased about losing their grants, but their comments offer insight into the process. We are not identifying them in this piece. To do so would place an unnecessary onus on them, given the current practices in the scientific grant community and the different monitoring procedures at the NIH. None of the issues with the grants appear to involve malfeasance.

One of the researchers said he was “bitter” about CIRM's action, declaring it caused a “huge uproar” at his institution. (Prior to our conversation, we had heard unconfirmed reports about significant unhappiness on the part of recipient institutions.) This researcher said CIRM's monitoring practices were a departure from those of the NIH, which allows “the liberty to take the research where it leads you.” Nonetheless, he continues to support CIRM.

Another scientist said he parted “amicably” with CIRM but confirmed that its practices are different than the those of the NIH. (The NIH has not responded to our queries concerning how many grants it has revoked for lack of progress.)

This researcher told us,

“I think that it is very important for CIRM to closely monitor its grantees. As a California taxpayer, I want to know that state revenues supporting the CIRM effort are well utilized. Furthermore, CIRM (and its grantees) need to make good on the promise of translating the science of stem cell biology into novel therapies.”

The third told us in an email that his grant had been “prematurely terminated.” He said the work has been completed without the CIRM support and the research accepted for publication in a prestigious journal next year. He also called CIRM a “great organization” and expressed the hope that it will lead to “great cures.”

The round of grants that Csete reported on involved only $45 million, substantially less than the $230 million in the disease team round. The stakes are now much larger. Powerful teams, some international, will be at work. Impending clinical trials will also create a vision of handsome profits, in addition to hoped-for prestige and accolades. CIRM directors have indicated they expect some of the disease team grants to fail. But revoking funds for one of those grants or loans will require a lot of steel on the part of the CIRM staff.

Csete abruptly resigned from CIRM after the June meeting. Her departure and the workload at CIRM likely meant that some of the monitoring efforts were pushed back. Most of the work is done by science officers, but at crucial points, it requires the intervention of CIRM's highest level scientist.

In the wake of Csete's departure, CIRM President Alan Trounson created a new position, vice president for research and development. A search firm has been hired for $100,000 to help recruit a candidate who will make go, no-go decisions on the disease team round along with other grants. Trounson is hoping to find someone with substantial experience in the biotech industry.

Whoever fills the job should not only be something of a scientific diplomat but also be able to face the big dogs of stem cell science and tell them no. CIRM's first responsibility is to generate results for the people of California and to serve as ardent stewards of the public's money.

(Below is a transcript of the entire discussion by the CIRM board in June concerning Csete's monitoring effort. Also below is a piece concerning our decision not to publish the names of the scientists whose grants were revoked as well as another item dealing with CIRM's efforts to ensure compliance with its ethical and research standards.)

Editor's note: The California Stem Cell Report first published an item on the termination of CIRM grants last April. Here is a rundown on all the stories published on this site as of Nov. 9, 2009, concerning grant termination.

CSCR Withholds Names of Terminated Grantees to Avoid Unnecessary Harm

The California Stem Cell Report is not naming the three scientists whose grants were terminated by the state's stem cell agency because doing so would unnecessarily damage their reputations.

It is our understanding that none of the issues involved malfeasance. Additionally, CIRM's progress monitoring appears to be more rigorous than the standards applied by the NIH, whose practices have set benchmarks in the scientific community.

Publication of the names could create erroneous, negative perceptions about the individuals involved.

We made the decision not to publish their identifies after discussions with a number of individuals, including two of the researchers. In our past occupation as an editor at a mainstream newspaper, publication of their identities would have been pretty much of a foregone conclusion. But given that we are no longer constrained by newspaper standards, some of which are very good and some not so good, we did not want to mindlessly do something that would unnecessarily harm the three.

We also asked CIRM director Floyd Bloom, former editor of Science magazine and executive director, science communication at Scripps, for his thoughts on publication of the names. Here is how he responded.

“For NIH grants, after the grant is awarded, one writes a 'progress report' annually in what is termed a 'non-competitive' renewal. For the duration of the award, the investigator is free to follow leads, change directions, convert personnel into equipment funds, and essentially re-program the proposed project. Only if the PI seeks to renew that grant must the changes be justified.

“In process described to us in June by Marie Csete, the scientific staff are in frequent contact with our CIRM-supported PIs, assessing their progress towards the goals they were approved to pursue, and for several of our competitions with stated milestones, assessing whether that progress will get them to their milestones. Lack of progress can be sufficient grounds to terminate the funding, and apparently those are the 3 cases you mention. Since we are kept blind to the PI names and institutions when we decide to award funding, I don't see that it is constructive to CIRM or those PIs to disclose names after termination.”

Text of Csete's Description of CIRM Grant Monitoring

On June 17, 2009, Marie Csete, then chief scientific officer for the $3 billion California stem cell agency, briefed its directors in San Diego on how CIRM monitors the progress of its grantees. Following her presentation, one director asked her how many grants had been terminated because of lack of progress. Three, she replied.

Here is the transcript of her remarks and the discussion by directors. Here is a link to the slides that she used. They begin on p. 22 of the file.

Csete: I guess the last thing I'm supposed to speak about is our mechanism for looking at progress reports. And the first opportunity we had to aggregate data on this was for the SEED grants, which are now more or less in their second year of funding for most of the investigators. And as a reminder, I think all the way back a few years, this was a grant program designed to develop human embryonic stem cell biology in the state. And since it was early, it was more idea based rather than preliminary data-based, and we really hoped to attract nonstem cell biologists to the field as well as cell and developmental biologists who were working perhaps on other stem cells, but had not done human embryonic stem cell work.

As such, the seed grants were acknowledged to be rather high risk, high gain. And I was involved in the SEED grants as a reviewer. So I have insight into the process from the beginning even before I came here to CIRM. I have to say that the overwhelming message I want to leave you with here is that despite a slow start, that was the bump in the road, that the SEEDs are really overwhelmingly successful. And we looked this week to find that there are already 64 papers coming out of the SEED program even though, again, these were new investigators in this field.

So it is important also, thanks to Bettina (Stephen, a CIRM science officer), to remind you that progress reports are not just progress reports -- and this has been an education for both the science office and for our scientists – that they really serve as a focus of a way that the science officers and our grantees can have a point of communication. It also allows us to get a heads up on where the data is, on what papers are being submitted, on potential patents that are coming out. Also when we discuss the progress reports in the science office meeting, it allows us to match scientists from our individual portfolios with other scientists whose progress we're hearing about in the meeting. In general, I have to say that I've gotten a lot of positive feedback from our PI's about the interactions with our science officers and our grantees.

So this is the process that we've sort of come to. And I've condensed a very complex diagram that has arrows going out every which way. On the right(on a slide she presented), you have a lot of gold stars. And the gold stars is what usually happens. On the left I put symbols showing how much communication happens at each one of these steps. So for the vast majority of the progress reports, things look good, and we generate an NGAs(notice of grant approval) with the next year's funding on the SEED grants.

But what I'm showing you in the middle is what happens when we receive a progress report that's not satisfactory. So we did receive some where we saw that the projects were not advancing. They were slow. The vast majority were those gold stars that, you know, went right back for the second year of funding.

In general, I have to say it was slow progress. It wasn't bad progress. And it allowed us to identify some issues that are, I think, endemic with a new agency and new ideas. institutions had trouble getting lines for their investigators. People had trouble hiring post docs who were able to do the work. We had trouble getting some of the NGAs out the door for various reasons. So right away, by having a communication with the PI after the progress report was in, we could help them. We could intervene and make the right calls to try to get and kick start these programs.

When there was insufficient data for us to judge how much work had been done, the science officer would request supplemental data. That often required a couple of phone calls and a couple of exchanges of e-mail because, again, we were interested in hearing what people would normally not send in as a progress report: difficulty getting cell lines grown, difficulty doing certain kinds of experiments so that we could see common features across our SEED grantees and allow them to help each other.

When the supplemental data suggested that there was still insufficient progress, I would look at the report, and we also had discussions with the entire science office. At that point, if we couldn't come to a way to jump start a project, we would have a conference call with the PI, and at this point we'd bring in the institutional official as well, the science officer who has this PI in their portfolio, and I, and we would have another call to try to get this program back on track. And very often what that meant was that we made a plan with the investigator to give them some more time so that they could generate some data and try to pick up where the progress was slow. So the time differed depending on the problems that were there, hiring problems, for example. If after this time period another supplemental progress report comes in and there was inadequate progress, we decided that we would notify the investigator that the project just didn't seem to be going anywhere, that there was no real plan to get it back on track and that there was a potential for termination.

Again, the AOOs were all involved in this as well. and if there was no response within two weeks to that potential termination letter, then the grant was terminated and the second year's funding was not advanced.

So what did we learn from this process? We learned that it's critical for us to be working with the PIs to keep the grants on track and how appreciative the PIs are when we do work with them to keep them on track. By the way, we also found several grants that would not have gone on because the investigator was interested in not pursuing the original goal of the research and was going to drop the work. We felt that these areas were so critical for the ideas that were part of the seed program, that we found other investigators who were co-PIs or related to the grant to take over and worked with these new investigators and found mentorship to keep that work going. So it went in both directions. We saw adequate progress where the grants would not have gone on had we not intervened. And I think that this is a very interim report for you because the final success of the SEEDs will be seen over the next year when the final reports come back. We know that papers are going out. We know that research is proceeding apace now; I think much to the effort of each of the individual science officers who worked very closely with the grantees. But it will be important to evaluate how many new labs were brought into human embryonic stem cell and pluripotent stem cell research. And I should also say that a lot of the investigators left to their own devices would have stopped what they were doing with their SEED grants and simply gone on to derive ips cells, and we would have had no portfolio had we (not) been actively managing the grants. But most importantly, the success of this program will be determined on how these investigators go into others of our programs and other large-scale funded grants with the work that was developed from the SEED. And we already have success in that area. We're seeing that one SEED grantee continued on and got an early translation award from CIRM last month.

So overall we've had enormous success, I think, with the SEED program, and we're still in the middle of it. And we've learned a lot about process that will help us to be managing larger scale projects and to work with our investigators in a really positive way.

CIRM Chairman Robert Klein: So, Dr. Csete, will you remind us the number of SEED grants originally awarded?

Csete: Seventy-four.

Klein: So 74 grants, and we've seen 62 or 63 papers at this point.

Dr. Csete: Sixty-four papers.

Klein: So a very high level of productivity. Thank you very much.
Dr. Bloom?

Director Floyd Bloom: This kind of nurturing interactive relationship with the PIs is absolutely unique in the grant world. And so I think it's a wonderful thing that you've instituted. It's going to be a tremendous amount of additional work on your staff to be able to do that, but it's highly commendable, and it's going to make the difference between success or failure, particularly for these intermediate level of successful early experiments where they have to be encouraged to go on and push. So it's a wonderful thing you've done.

Director Ricardo Azziz: I just want to echo that, for starters. I think it takes a tremendous amount of work to help these investigators forward. Again, presumably, they are also very appreciative of your efforts. of the 74 applications, how many – you spoke about the process that you are going through -- how many have been terminated for nonproductivity?

Csete: Three.

Azziz: Three of the 74. Thank you.

Klein: Okay. any additional board comment? Thank you very much, Dr. Csete.

CIRM as Regulator, Compliance Enforcer

In addition to handing out $3 billion in grants to California stem cell researchers, CIRM is also a regulator, monitoring the conduct of its grantees' research to ensure they adhere to the agency's stringent ethical standards.

The subject came up briefly at last week's board meeting in Los Angeles and is expected to come up again at the board meeting in December.

Geoff Lomax, senior officer for medical and ethical standards, had prepared a presentation to discuss, among other things, the agency's research standards monitoring program. But it was caught in the hurly-burly surrounding the disease team applications and was delayed until the next board meeting.

However, his slides are available and provide an introduction to the scope of what CIRM calls its compliance program.

The effort includes financial tracking, reporting on publications and IP and examination of institutions' own oversight programs along with site visits.

Lomax's slides also said,

“CIRM provided recommendations to two institutions regarding the need for more explicit procedures and policies to govern their oversight programs.

“CIRM identified one patent that had not been reported; grantee has now addressed.

“CIRM has worked with two grantee institutions to ensure compliance with AALAC (animal care accreditation) requirements.”

Lomax's slides start with number 25 in this file.

CIRM Pulls Three Grants from Researchers

SAN DIEGO -- The California stem cell agency tonight said it has terminated three research grants for lack of progress, but declined to release immediately the names of the researchers or the institutions involved.

James Harrison, outside counsel to the CIRM board, acknowledged that the names were public record but said the agency wanted time to work out a well-considered way of releasing the information.

Marie Csete, CIRM's chief scientific officer, disclosed the terminations during a report on the progress of CIRM grants. The information came in response to a question from board member Ricardo Azziz, chairman of the department of obstetrics at Cedars-Sinai Hospital n Los Angeles.

She said efforts to monitor the progress of grants were generally well-received by investigators. She said that they discovered several grants that would have been abandoned without the progress monitoring effort by her staff.

Board member Floyd Bloom, executive director of science communication at the Scripps Institute, said the monitoring effort is a “wonderful thing.” He said CIRM's “nuturing relations with PIs is absolutely unique in the grant world.”

CIRM Pulls a Grant, Aggressive Monitoring Reported

In what appears to be a first, the California stem cell agency has pulled at least one grant from one of its researchers, apparently because of a lack of progress.

Don Gibbons, CIRM's chief communications officer, confirmed the action in response to a query from the California Stem Cell Report.

Gibbons refused to disclose the identity of the researcher or the institution, declaring that more details would be forthcoming in a report to the CIRM board of directors from President Alan Trounson at its meeting in San Diego on Wednesday and Thursday.

We asked CIRM about the withdrawal after we were told by another source that one grant had, in fact, been been pulled and some “push-back” was coming from institutions. At the last CIRM board meeting in April, a report on grant monitoring was on the agenda but was removed with no explanation.

Here are the questions we directed to Gibbons last week.

“Can you confirm or deny that a grant has been pulled?
“Are institutions pushing back in any form whatsoever?
“Are any of the board members involved in any way whatsoever in reactions to monitoring of grantees' progress?
“What was the reason for removal of the monitoring item from the agenda last month?
“Will it be rescheduled?
“Do you have any other comments on this general subject? “

Gibbons replied,

“Yes, we have pulled at least one grant, but the leadership of the science office uniformly reports they are not getting push back from the institutions. No board members were involved in the process. The last board agenda was jammed so plans were made to include the progress reports in the President’s Report for the upcoming meeting. You can hear the details then.”

(The last board meeting ended at 1:24 p.m. on April 29, which is early for most board meetings.)

Gibbons has not responded to an additonal question on June 10 seeking the identity of the researcher and the grant number, both of which are public record.

Marie Csete, chief scientific officer for CIRM, and her staff have been aggressive in checking progress on CIRM grants, we have been told. Some grantees have been surprised and have complained that the NIH does not follow the same practice.

CIRM is to be lauded for monitoring the grants carefully. While strong oversight of grants may be bothersome to some researchers, institutions and perhaps some CIRM directors, it is a healthy practice that should stand CIRM in good stead when it faces its skeptics.