CIRM Board Member Prieto Critiques the IOM Stem Cell Report

Francisco Prieto, a member of the governing board of the $3 billion California stem cell agency, is expressing some additional dissatisfaction with the blue-ribbon Institute of Medicine (IOM) report for which the agency paid $700,000.

The report recommended sweeping changes at the agency, including creation of a new majority of independent members on the board. The IOM cited problems arising from the built-in conflicts of interest on the board that were created by Proposition 71, which created in the agency in 2004. Prieto's email refers to Bob Klein, who is a real estate investor and attorney. Klein oversaw the drafting of the 10,000-word ballot measure(writing much of it himself), ran its $35 million ballot campaign and became the first chairman of the agency. The qualifications for chairman were written into the proposition and seemed to uniquely apply to Klein.  Prieto is a Sacramento physician who was appointed to the board as patient advocate.

.Here is the text of Prieto's comments. His earlier comments can be found here.

“A few more words on independence, and the IOM.  I think Bob Klein drafted the proposition (and remember, all of this was spelled out there – readily available to the voters and whatever news sources they were depending on for information) deliberately to engage patient advocates. I think  he knew that those of us who have been active in disease advocacy have a passion around the issue of advancing research that someone without that background would be unlikely to have. I’m not sure exactly what the IOM had in mind when they called for more 'independent' members of the board, since they very unfortunately did not bother to interview the patient advocates on the ICOC(the governing board). I don’t know what their reason for this was, if there was one, but they only circulated a (in my view) frankly inadequate questionnaire, and interviewed a small handful of people. I think this was a major flaw in their process and gave them a very limited view of our role. It is hard for me to imagine who they might have in mind, if not people who had been involved with some existing advocacy organization. I think there are very few if any patient advocates who aren’t working with some group – the only ones I might imagine would be some independently wealthy person able to start a foundation or research institute on their own.  With all due respect to Bill Gates and the great work his foundation is doing with malaria and HIV, I have written before that I think it would be absolutely wrong and anti-democratic to create any public board or commission that only millionaires could sit on.”

An anonymous comment was also posted concerning the IOM report and conflicts of interest. It dealt briefly with the issue and difficulty of managing conflicts. The comment can be found at the end of this item.

Stem Cell Agency Board Member Defends Independence of Many on Board

A member of the governing board of the California stem cell agency is taking exception to a statement on the California Stem Cell Report that no independent members sit on that body.

Francisco Prieto, a Sacramento physician and a patient advocate member of the board, referred to the “ethical minefield” item Feb. 5, 2013. Here is the text of what Prieto wrote,

“I have to object to this line: 'None of the current members are independent. The ballot measure that created the agency required board members to be appointed from various constituencies.' 

“I think I am absolutely independent, and I think the same applies at the very least to most if not all of my fellow patient advocates, and probably to the biotech representatives as well – remember that they all must come from companies that are not involved in stem cell research.  Although I supported the proposition, I was not involved directly in the campaign in any way, and I did not meet Bob Klein (the first chairman of the stem cell board) or any of my fellow board members until the day I was sworn in at our first meeting.

“The Prop. 71 language I believe specifies that advocates must have a record of advocating for people with the disease or diseases they represent, and not that they belong to or work for any specific organization.  Checking my binder, it refers to 'groups' but does not specify those – for example, it refers to 'representative of a California regional, state or national HIV/AIDS disease advocacy group.' I’m not sure how you would define 'independent' but I certainly don’t think it means 'disinterested.'”

Our take: The Institute of Medicine(IOM) called for a new majority of what it described as independent members, obviously not finding sufficient, if any, independent members on the agency board. The IOM, the most prestigious organization of its kind in the country, said changes were needed because of damaging conflict of interest issues at the stem cell agency.

Prop. 71, which created the stem cell agency in 2004, was carefully crafted to avoid the use of the word “independent” when describing the necessary qualifications for a board member.

 Instead the measure required that, in some cases, they must come from very specific education institutions. (You can find the CIRM summary of all qualifications within this document.) In other cases, the speaker of the state Assembly appoints “one representative of a California regional, state, or national mental health disease advocacy group.” The leader of the state Senate appoints “one representative of a California regional, state, or national HIV/AIDS disease advocacy group. “ Four other statewide elected officials appoint an executive from a “California life science commercial entity.”

Prieto is correct when he says he believes he is “absolutely independent.” But he fills a category that represents a special constituency. What is missing from the board is anyone who does not come from one special constituency or another. The board was constructed in that manner to make sure it would win the broadest measure of support from all the various major constituencies by guaranteeing them a seat at the table where the money is handed out.  Ironically, the full formal name of the CIRM governing board is the "Independent Citizens Oversight Committee," a piece of political legerdemain to mask the actual nature of who would sit on the board. 

Riverside Newspaper: 'Ethical Minefield' Still Not Cleared at Stem Cell Agency

The California stem cell agency's attempts to deal with the conflict of interest problems at the $3 billion research program amount to a minor fix that is not a “serious solution,” the Riverside Press-Enterprise editorialized yesterday.

The editorial came as the agency launches a road trip campaign to convince newspaper editorial boards around the state that the agency is worthy of continued financial support. The agency will run out of money for new grants in less than four years.

The Riverside editorial pointed to the blue-ribbon Institute of Medicine report in December that called for creation of a new, independent majority on the 29-member board. None of the current members are independent. The ballot measure that created the agency required board members to be appointed from various constituencies.

The newspaper said,

“That arrangement is hardly a model of objective decision making. The agency so far has distributed about $1.7 billion in grants, with about 90 percent of that money going to institutions represented on the governing board. 

“Voluntary abstentions are not a serious solution to that ethical minefield. Nor would that approach eliminate potential conflicts, because the agency would still allow the abstaining members to take part in the discussions and debate about who should get the grants. 

“The Institute of Medicine instead recommended remaking the board with truly independent members who have no stake in grant awards. The stem-cell agency rejected that step because it would require changing Prop. 71, either through a super-majority in the Legislature or another ballot measure. That excuse should be a vivid warning to Californians about the dangers of passing complex, costly and inflexible initiatives. 

“Agencies handling billions of taxpayers’ dollars should not avoid good government practice or basic fiscal safeguards. The stem-cell institute offers minor fixes when it needs substantial changes — and legislators should not accept that cavalier approach.”

Debunking California Stem Cell Agency Claims of 'No Actual Conflicts'

In the wake of recent considerable criticism concerning conflicts of interest at the $3 billion California stem cell agency, its leaders have taken to saying “no actual conflicts” have been found at the agency.

That assertion is simply not true.

Nonetheless, the statement has been repeated in some news stories, published in at least one agency press release and peddled by stem cell advocates and some members of the governing board of the California Institute for Regenerative Medicine (CIRM), as the agency is formally known.

The reason? Conflicts of interest were cited prominently as a major problem at CIRM by the blue-ribbon Institute of Medicine (IOM) report. In December, the IOM recommended that a new majority of independent members be created on the stem cell agency's governing board. The existing stem cell board has ignored that recommendation and wants to settle for something considerably less as it tries to find a way to build support for continued financing of its efforts.

The facts are that the agency has a long history of problems involving conflicts of interest, “actual” and otherwise. Here is a rundown on what has been reported on the California Stem Cell Report.

In 2009, board member John Reed, then CEO of the Sanford-Burnham Institute, was warned by the state's Fair Political Practices Commission about his violation of conflict of interest rules. Reed's intervention on behalf of a grant was made at the suggestion of then CIRM Chairman Robert Klein, an attorney who led the drafting of Proposition 71, the ballot initiative that created the stem cell agency in 2004.

In 2007, other violations involving five board members resulted in voiding applications from 10 researchers seeking $31 million. And then the agency shamefully scapegoated employees for the problem.

In 2011, the chairman of the CIRM grant review group resigned from his position as the result of another violation, which the agency felt necessary to report to the California legislature.

In 2009, then board member Ted Love, who has deep connections to the biomedical industry, served as the agency's interim chief scientific officer and helped to develop the agency's first, signature $225 million disease team round while also serving on the CIRM board. As chief scientific officer, Love presumably would have had access to proprietary information and trade secrets contained in grant applications. In 2009, in response to questions from the California Stem Cell Report, the agency said that Love would only serve as a part-time adviser to the agency president, not as chief scientific officer. Nonetheless, in 2012, the board passed a resolution with high praise for Love and his performance as the chief scientific officer.

Since 2010, a stem cell firm, iPierian,Inc., whose major investors contributed nearly $6 million to the ballot measure that created the stem cell agency, has received $7.1 million in awards from the agency. The contributions were 25 percent of the total in the campaign, which was headed by Klein.

Another firm, StemCells, Inc., last fall was awarded $40 million by the CIRM board despite having one of its $20 million applications rejected twice by grant reviewers. The action came after the board was vigorously lobbied by former Chairman Klein. Researcher Irv Weissman of Stanford, who founded StemCells, Inc., and is on its board, was featured in a TV campaign ad for Proposition 71 and helped to raise millions for the ballot campaign. 

In 2008, public complaints by one applicant from industry about conflicts of interest on the part of a reviewer were brushed off by Klein. He told the applicant the board needed to discuss naming CIRM-funded labs and then go to lunch. 

The agency has hired at least two industry consultants in positions that raise conflict of interest problems, in 2010 and again in 2012.

Sometimes groups expect to see increased funding as the result of the appointment of sympathetic individuals to the board. That occurred last fall when Diane Winokur was appointed. The chief scientist for The ALS Association, said Winokur will be “a tremendous asset in moving the ALS research field forward through CIRM funding."

The conflict issue even surfaces in picayune ways. In 2006, board members from various institutions spent considerable time debating a minor requirement involving press releases. They were concerned that the proposal would make their institutions subordinate to the interests of CIRM. At the end of the discussion, the institutional directors prevailed and kept their PR departments from having to notify CIRM about press releases dealing with the hundreds of millions of dollars in state grants that they receive.

All this, and yet on Jan. 24, 2013, CIRM Chairman Jonathan Thomas was quoted in a CIRM press release as saying “no one has found any actual conflicts” at the agency.

In the media, some of the recent news stories have reported that the IOM did not find any “actual” conflicts at the agency. The explanation for that is simple, but mainly omitted from the articles. The IOM did not look for any conflicts of “inappropriate behavior,” as its report clearly states. The California Stem Cell Report last weekend asked the chairman of the IOM panel, Harold Shapiro, why it did not look for conflicts. He replied,

“Our committee was given a set of defined tasks from the IOM(which was under a $700,000 contract with CIRM), and we followed them."

Nonetheless, the IOM report said “far too many” board members are linked to institutions that receive funds from CIRM. A compilation by the California Stem Cell Report shows that about 90 percent of the $1.7 billion that the board has awarded has gone to institutions linked to past and present board members.

The fundamental conflict problem with the CIRM board is that nearly all the California institutions that stood to benefit from the agency's largess were given seats at the table where the money is handed out, under the terms of Proposition 71.

Conflict problems are not unique to CIRM and government agencies. They are also a matter of concern at nonprofit, grant-making foundations, which in some ways CIRM resembles.

The Council on Foundations, a national nonprofit association of more than 1,700 grant-making organizations, takes pains on its web site to explain the importance of managing and avoiding conflicts of interests. In its advice to its members, the group makes it clear that the issue goes well beyond simple financial conflicts. It says,

“(Board) members must represent unconflicted loyalty to the interest of the foundation. This accountability supersedes any conflicting loyalty such as that to advocacy or interest groups, business interests, personal interests or paid or volunteer service to other organizations.”

In the case of the stem cell agency, the “unconflicted loyalty” is to the people of California. Perhaps the California stem cell agency can convince state leaders, both public and private, and its voters that no conflicts exist at the state agency. But it is a big bet and probably carries with it the entire future of what the board and many believe is an exceedingly promising scientific effort.

Perhaps it would be wise for the board to step back and say, “Yes, there are serious conflict problems at CIRM. We recognize that and are working on additional measures to create an independent board as recommended by the IOM.”

Sacramento Bee: Stem Cell Agency Falling Short on IOM Recommendations

It's exceedingly rare when the California stem cell agency makes the front page of any newspaper.

So it is worthy of note that The Sacramento Bee this morning carried a lengthy piece on its page one about the agency and its response to the blue-ribbon Institute of Medicine (IOM) report.

The headline said,

 “Analyst: Stem cell agency reforms fall short.”

The analyst is the Institute of Medicine, more specifically Harold Shapiro, chairman of the panel that studied California's $3 billion research effort for 17 months at a cost of $700,000 to the agency.

Bee reporter Cynthia Craft wrote that Shapiro said the stem cell agency is “falling short” in its response to the IOM recommendation.

Craft wrote,

"'There certainly is a gap between what we recommended and what they responded with,' said Shapiro, president emeritus at Princeton University. ' I wish they had moved closer to our recommendations.'"

Craft said the IOM made sweeping recommendations “emphasizing the need for new blood on a governing board that has been plagued by the appearance of conflicts of interest, cronyism and sluggishness in getting stem-cell products to market.”

Craft also interviewed Jonathan Thomas, chairman of the stem cell agency, who said some of the IOM recommendations would take legislative action. But Thomas said that was “out of the question.”

Craft wrote,

“The process would take years, he said. The first opportunity to get on the ballot, for instance, would be in the fall of 2014.”

The agency will run out of cash for new grants in less than four years.

Craft's story was the first major news article in years about the agency in the Bee, the only daily newspaper in the state's capital. She reviewed a bit of the history of the agency and concerns about conflicts of interest. She concluded,

“Shapiro said he stands firmly behind his committee's report. 

"'I think our recommendations sit together and interrelate to each other well – and should have been moved along as quickly as possible,' Shapiro said. 

"'It might have been helpful if they indicated to us what they were willing to do and what they weren't,' he said."

Hyping the Economic Impact of the California Stem Cell Agency

The $3 billion California stem cell agency today served up a warmed-over version of a study that would have the public believe that the research program has had a major economic impact on the state.

The latest study was prepared last August by a firm that was hired under an RFP in 2010 that said it must execute "a vibrant and aggressive strategy to support the goals and initiatives of CIRM.” 

The agency paid $300,000 for the original study but contends the report is “independent” of CIRM.

According to the CIRM press release today, the latest version of the study by Jose Alberro of the Berkeley Research Group claims creation of 38,000 “job years” and $286 million in “new tax revenue” from the award of $1.5 billion. Those awards actually cost something in the neighborhood of $3 billion, given that state taxpayers must pay interest the borrowed funds that finance the agency. 

The Institute of Medicine's recent blue-ribbon report on the stem cell agency carried remarkably different information than the economic figures reported today. The institute's study was also financed by CIRM but at a cost of $700,000. The report said,

“In the short term, CIRM’s expenditures are supporting approximately 3,400 jobs and their innovative efforts have also attracted substantial additional private and institutional resources to this research arena in California CIRM’s long-term impact on such critical aspects of the California economy as state tax revenues and health care costs beyond the shorter-term and temporary impact of its direct expenditures cannot be reliably estimated at this point in CIRM’s history."

Here is what the California Stem Cell Report wrote in 2011 when the first study was released:

“No doubt exists that the stem cell spending has had a beneficial economic impact. But whether it has had a 'significant' impact on the California economy is in the eye of the beholder. The state's economy runs to something like $1.7 trillion a year. If California were a nation, it would rank among one of the larger economies in the world. The workforce totals around 18 million, making 25,000 jobs statistically less than a hiccup. Keep in mind as well that CIRM, until 2009,  paid the interest on its borrowing with more borrowed funds, all of which adds to the total cost of the borrowing, which is about $3 billion on top of the $3 billion CIRM is handing out.”

By ballyhooing economic impact reports the stem cell agency would seem to be inviting assessment of its efforts as an industrial development enterprise, which involve criteria significantly different than that of a research enterprise. A few years ago, we asked the agency's then Chairman Robert Klein whether he wanted to have CIRM assessed as industrial development effort. His quick response was a very emphatic no. Klein nonetheless frequently touted the figures produced under the contract with the agency.

The latest figures are undoubtedly likely to be cited as the agency begins a road trip around the state to meet with newspaper editorial boards to trumpet CIRM's reponse to the Institute of Medicine study.

See below for a full copy of the report. We have asked CIRM for a copy of the contract with the group that prepared it. We will carry it when we receive it.

CIRM Economic Impact Report 2012 by

   

Los Angeles Times Columnist: Stem Cell Agency Still Saddled with Conflict of Interest Problems

The governing board of the $3 billion California stem cell agency will remain dominated by “special interests” even with the adoption of a plan last week responding to the far-reaching recommendations of a blue-ribbon Institute of Medicine (IOM) study, a columnist for the Los Angeles Times said today.

Michael Hiltzik, Pulitzer Prize winning writer and author, wrote that IOM study showed the agency “the path to cleansing itself of its aura of connivance and influence trading. That the board can't even bring itself to place the proposals before the voters or their elected representatives only shows how much money it's willing to waste to keep living in its own little world.”

Hiltzik's column in California'slargest circulation newspaper included fresh comments from both Harold Shapiro, who chaired 17-month IOM study, which was commissioned by CIRM, and Jonathan Thomas, the chairman of CIRM and who drew up the response.

Hiltzik wrote that the study “concluded that the CIRM board members were saddled with 'almost unavoidable conflicts of interest, whether actual or perceived.'” He continued,

“That's because by law, 23 of the 29 members must be representatives of California institutions eligible for CIRM grants or of disease advocacy groups with their own interest in steering money toward their particular concerns. 

“As a remedy, the panel proposed eliminating some board slots reserved for grant-receiving institutions by Proposition 71, the 2004 initiative that created the agency. The idea was to fill those slots with truly independent members free of any stake in CIRM funding, even indirectly.”

 Hiltzik wrote,

 "Thomas told me his proposal dealt with even perceived conflicts of interest on the board in such "definitive fashion" that it won't be necessary to bother the Legislature, much less the voters, with such big changes as remaking the board with a majority of independent members. He pointed out, not without some pride, that one board member called his proposed changes 'draconian.'"

Hiltzik had some praise for Thomas.

“Let's stipulate that Thomas has, in CIRM terms, moved a mountain by jostling the board even this far. Since its inception, the board has set records for arrogance. That's a direct legacy from Proposition 71, which exempted the stem cell program, uniquely among California government bodies, from any practical oversight by the Legislature or elected officials.”

The Times columnist continued,

“Shapiro told me from his Princeton office that Thomas' proposals were 'a significant step in the right direction, which at least indicates that they haven't ignored the report.' But he doesn't share Thomas' view that voluntary recusals solve the conflict of interest problem. That can be done, Shapiro said, only by replacing stake-holding board members with independents.

"'The more you can reduce the inherent conflicts, the better off everyone is going to be,' he said. The board will 'have to go further over time, in my view.'"

Hiltzik wrote,

“The Shapiro panel said it didn't find any instances of inappropriate behavior by board members or specific conflicts, but there are two reasons for that: It didn't search for any, and Proposition 71 defined certain conflicts out of existence. The measure states that it's no conflict for a board member to also be an officer of an academic institution or private corporation that might be applying for grants.

“One of the CIRM board's enduring self-delusions is that its conflicts of interest are purely a matter of 'perception.' But there have been documented instances of favoritism shown to well-connected grant or loan applicants, and at least one overt attempt by a board member to overturn a rejection of his institution's project. So much of the board's discussion takes place behind closed doors or informally that the opportunities for mutual back scratching are incalculable.

“Thomas' 'draconian' proposals won't change this state of affairs. Special interests will still dominate the board. Will barring 13 members from voting on grants while giving them full rein to participate in discussions really eradicate even the perception of conflicts? You'd have to be terminally naive to think so.”

Stem Cell Agency Plan Falls Far Short of Solving IOM Concerns

The governing board of the $3 billion California stem cell agency last week fell far short of complying with the recommendations of a blue-ribbon Institute of Medicine (IOM) study that the agency itself commissioned to improve its performance.

Many of the proposals by the IOM dealt with conflicts of interest at the eight-year-old agency, which board members reluctantly recognized on Wednesday as a perception problem. Under the plan approved last week, 13 of the 29 members of the board would not be allowed to vote on any awards. They are members tied to institutions that benefit from funding. Three other board members linked to those beneficiary institutions, however, would still be allowed to vote on grants other than those to their institutions. .

The board did nothing to deal with the structural issues involving conflicts of interest that are built into the board as the result of Prop. 71, the ballot measure that created the research effort in 2004. The 29-member board was constituted in such a way as to give nearly all institutions that could benefit a seat at the table where the money is handed out. It is as if the state's Public Utility Commission, which sets utility rates, were dominated by executives of the utility companies.

Under longstanding rules, individual members of the stem cell board are barred from voting on grants to their institutions. However, the board still determines the game and the rules. The board approves the specific areas of research for funding, approves plans for individual RFAS, sets the rules for the grants and loans and enforces compliance through CIRM staff.

The board last week limited itself to changes that it could enact on its own. Many of the IOM recommendations, including a new majority of independent members, would require legislative action, which opens the agency to a wider range of changes than even the IOM recommended. That is not a prospect the agency relishes. Nonetheless, how well the board complies with the IOM recommendations is likely to be critical to its plans to raise funds to continue its operations beyond 2017, when the taxpayer cash runs out for new grants.

Here is a look at the key IOM recommendations and the response so far from the stem cell agency(see here and here). More details may emerge between now the next CIRM board meeting in the San Francisco Bay Area March 19, when the board is schedule to finalize its IOM plan. 

IOM Recommendation

“Change the Composition and Structure of the Board and Working Groups.

“CIRM should put systems in place to restructure the board to have a majority of independent members, without increasing the size of the board. It should include representatives of the diverse constituencies with interests in stem cell research, but no institution or organization should be guaranteed a seat on the board. Consideration should be given to adding members from the business community....The chair and other ICOC members should be prohibited from serving on the working groups. During the reconstitution of the working groups, the current level of representation of disease advocates should be maintained, such board members being replaced with other disease advocates who are not board members.”

CIRM Response

The Thomas plan basically is a total rejection of this recommendation. The CIRM board does not support creation of a new majority of independent members, which would mean some current members would lose their seats if the board were not increased beyond 29 members. No members will be added from industry. Board members will continue to serve on the grant review panel and other groups, contrary to IOM recommendations. In the case of grant reviews, however, they would no longer vote in the closed door sessions. The board has no plans to add patient advocates who are not board members to working groups, including the grant review panel. The University of California will continue to have five guaranteed seats on the board. No independent members currently sit on the board.

IOM Recommendation

“Revise Conflict of Interest Definitions and Policies.

“CIRM should revise its definitions of conflict of interest to recognize conflicts arising from nonfinancial interests, such as the potential for conflict arising from an individual’s interest in a specific disease, and should reassess its policies for managing conflict of interest in light of this broader definition.”

CIRM Response

CIRM has no plans to move to prevent nonfinancial conflicts of interest. Several board members expressed strong opposition to such an effort. Sixteen persons who sit on the board have ties to institutions that receive CIRM funds. Currently individual board members cannot vote on applications from their institutions. To avoid the appearance of conflicts of interest, the Thomas plan would have the 13 members directly appointed from beneficiary institutions voluntarily abstain from voting on any grant applications. Apparently not affected under the Thomas plan would be three other board members who are appointed as patient advocates. Two of them are employed by beneficiary institutions. The third is chairwoman of the UC Board of Regents. All of the board members would continue to vote on plans for all rounds of grants, including determination of some of the specifics of the ensuing RFAs.

IOM Recommendation

“Restructure the Grant Review and Funding Process.

“CIRM should restructure the grant review and funding process to separate oversight and strategic planning from day-to-day operations. The ICOC (the agency's governing board) should remain responsible for oversight and articulation of an overall strategic plan. However, grant management, funding recommendations, and grant administration should be the responsibility of the CIRM scientific staff, reporting to the president. This restructuring would help mitigate concerns related to conflicts of interest and would also put the review and funding process in the hands of those best equipped to make those decisions.”

CIRM Response

CIRM patient advocate board members who serve on the grant review group would not vote on applications during the grant review sessions. They would be limited to voting at public board meetings. They would lead discussion of non-scientific considerations for approval of applications during the public sessions. Currently that occurs during the closed door review.

IOM Recommendation

Abolish the “extraordinary petition” mechanism for public appeals of negative grant reviews.

CIRM Response

Move all appeals to staff level and behind closed doors. Currently extraordinary petitions are handled in public board meetings, sometimes leading to lengthy, emotional sessions with presentations by patient advocates. The public in general, including grant applicants, continues to have the right under state law to address the board on grant applications or any other matter they wish.

IOM Recommendation

“Separate Operations from Oversight.

“The board should focus on strategic planning, oversee financial performance and legal compliance, assess the performance of the president and the board, and develop a plan for transitioning CIRM to sustainability. The board should oversee senior management but should not be involved in day-to-day

management. The chair and the board should delegate day-to-day management responsibilities to the president. Each of the three working groups should report to management rather than to the ICOC.”

CIRM Response

The Thomas plan does not appear to differ significantly from current operations, which reflect the troubling dual executive arrangement involving the chairman and president that was created by Prop. 71, the ballot measure that created CIRM. The existing arrangement is also a hangover from the days of the agency's first chairman, Robert Klein, and has been an obstacle in previous recruitment efforts for a president of the agency. The Thomas plan does eliminate a dual reporting arrangement for the chief financial officer, a position that has been vacant since last summer. Thomas indicated last fall that the position would not be filled. Both the chairman of the IOM study panel and the California state controller's office both say more needs to be done to separate operations from oversight.

IOM Recommendation

“Enhance Industry Representation in Key Aspects of CIRM Organization.

“Industry representation on the ICOC, the Scientific Advisory Board, the Standards Working Group, and the Grants Working Group should be enhanced to leverage industry’s expertise and resources in product development, manufacturing, and regulatory approval in support of the ultimate goal of bringing therapies to patients.”

CIRM Response

The Thomas plan would increase industry involvement “where appropriate.” However, industry has complained for years about this problem, and some board members as well. But little has been done to deal with the problem. Recently, the agency has taken some steps to engage industry, but the IOM was aware of those when it made its recommendation for closer cooperation.

IOM Recommendation

“Establish a Scientific Advisory Board.

“CIRM should establish a single Scientific Advisory Board comprising individuals with expertise in the scientific, clinical, ethical, industry, and regulatory aspects of stem cell biology and cell-based therapies.” Members of this board would be from out of state and replace existing advisory boards. They would be appointed by and report to president.

CIRM Response

CIRM says the structure and membership of the a new board is under discussion, but generally indicated it would go along this proposal. Not specifically addressed was abolition of other advisory groups.

Develop a “sustainability” platform in consultation with current and future partners, including sources of funding.

IOM Recommendation

Develop a “sustainability” platform in consultation with current and future partners, including sources of funding.

CIRM Response

Chairman Jonathan Thomas said he is working on details of a plan.

IOM Recommendations

“Incorporate Future Enforcement of Intellectual Property Policies in the Sustainability Platform.

“As part of the plan maximizing the continued impact of CIRM’s many achievements..., CIRM should propose regulations that specify who will have the power and authority to assert and enforce in the future rights retained by the state in CIRM-funded intellectual property.”

“Consider Harmonizing Intellectual Property Policies with Policies of Bayh-Dole Act.

“As other sources of funding for stem cell research become available and as the field of regenerative medicine advances from the laboratory to the clinic, the ICOC should reconsider whether its goal of developing cures would be better served by harmonizing CIRM’s IP policies wherever possible with the more familiar policies of the Bayh-Dole Act.”

CIRM Response

The governing board's IP Subcommittee will review the policies and make recommendations.

CIRM's Thomas: Conflicts 'Put to Bed' at Stem Cell Agency

The chairman of the $3 billion California stem cell agency, Jonathan Thomas, today hailed board action last week as putting “to bed once and for all” questions about financial conflicts of interest by members of the agency's governing board.

Writing on the agency's blog, Thomas pointed to board approval of a new policy that would bar 13 of the 29 members of the governing board from voting on any grants whatsoever. The 13 are the members who are “appointed from an institution that is eligible to receive money.” Three other board members have ties to institutions that receive money. Two are employees of the institutions and one is the chair of the University of California board of regents, Sherry Lansing. All three are appointed as patient advocate members of the board. Currently all 16 are barred individually from voting on grants to their institutions, but they can vote for awards to other institutions.

Thomas proposed the plan last week to the governing board, which approved it on a 23-0 vote with one abstention. Thomas advanced the proposal in response to the recommendations of a 17-month study by the Institute of Medicine(IOM). CIRM paid $700,000 for the blue-ribbon report, hoping that it would serve as the basis for continued financing of the agency beyond 2017, when funds for new grants run out.

The IOM's far-reaching recommendations included creation of a majority of independent members on the board, which would mean some current members of the board would lose their seats. No institutions would be guaranteed seats on the board. Currently five members are appointed from the University of California. The Thomas plan does not deal with those recommendations.

The IOM said “far too many” members of the board have ties to institutions that receive funds from CIRM. Compilations by the California Stem Cell Report show that about 90 percent of the $1.7 billion that the board has awarded has gone to institutions linked to directors.

Thomas said that the board last week “endorsed a framework of proposals that would dramatically change the way the board works, and directly addresses the concerns and recommendations of the IOM, in particular their feeling that the way our Board works could create a perception of conflict of interest.”

Concerning the change in voting for the 13 board members, Thomas wrote,

“It was not an easy change to propose and certainly not an easy one for our board members to approve. They all care deeply about our mission and devote a great deal of thought, time and energy to helping us do our work. So for 13 of them to agree to abstain from a key aspect of their work was difficult to say the least. And yet they did it because they felt it was important for the overall goal of the agency.”

Thomas continued,

“So why did we take this approach? It's simple. We want people to focus on the great work we do, on the groundbreaking research we fund, and the impact we are having on the field of regenerative medicine not just in California but throughout the U.S. and around the world. As long as there are perceptions of conflict of interest hanging over the Board, this will continue to be difficult.”

Thomas said,

“This puts the economic conflicts issue to bed once and for all.”

Loring on Patient Advocates and Their Role at the California Stem Cell Agency

The following statement by stem cell researcher Jeanne Loring was read at the January 23, 2013, meeting of the governing board of the California stem cell agency. Loring is director of the Center for Regenerative Medicine at the Scripps Research Institute in La Jolla, CA.

“I am sorry that I cannot attend this important meeting of the ICOC. I'm in Toronto reviewing stem cell grants for Japan and Canada. I've asked (patient advocate) Don Reed to read my statement.

“I am a California stem cell scientist whose research is funded by the NIH, private foundations, and CIRM. I am the director of one of CIRM's shared laboratories, which has provided formal training in research and ethics to hundreds of young stem cell scientists. My CIRM funding supports the stem cell genomics research that is the main focus of the lab. We have also been funded by CIRM to investigate stem cell therapies for Alzheimer disease and multiple sclerosis. I have leveraged CIRM grant support to obtain funding for studies of autism through the NIH, and for Parkinson's disease from a private foundation.

“The IOM report recommended a number of changes in CIRM's policies. One of these recommendations is of especially great concern to me: the suggestion that patient advocates should have much less influence in CIRM's decisions about what research should be funded.

“Patient advocates are extremely valuable to us researchers. Most of us stem cell researchers had never met a patient advocate- and perhaps not even a patient- before CIRM was founded. In my 20 years of being funded by the NIH, the funding agency never once suggested that I should talk to people who have the disease, or have relatives with a disease that I was receiving funding to study.

“With my first CIRM grant, I started meeting patient advocates, and now I can't imagine pursuing a disease-related research project without them. I've learned a great deal from the advocates on the ICOC, and I greatly enjoy talking with them. They are wonderful sources of knowledge: Jeff Sheehy taught me about HIV/AIDS and patient activism, I learned about Parkinson's disease from Joan Samuelson, autism from John Shestack, and David Serrano-Sewell, Diane Winoker have educated me about MS and ALS.

“Professional research scientists are competitive by nature- a conversation between scientists is often constrained by our secrecy- we need to publish, or perish. But advocates have no such constraints, which makes ICOC meetings more enjoyable and informative than many scientific meetings.

“Patient advocacy has made me a better scientist. Advocacy makes CIRM-funded research breathtakingly relevant and uniquely powerful to change the course of medicine.”

Patient Advocate Reed Defends Patient Advocates on Stem Cell Board

Patient advocate Don Reed, declaring that the Institute of Medicine's (IOM) 17-month study of the $3 billion California stem cell agency is "grossly misguided," this weekend nonetheless said the agency took "the high road" in its response to the study's recommendation.

Reed, of Fremont, Ca., was particularly incensed about the IOM's recommendations concerning patient advocates on the board. The IOM said that none of the board members, including patient advocates, should vote on grant applications secretly in grant review groups. The IOM said their votes should be recorded in public at full board meetings. Other patient advocates would still have seats on the grant review group, under the IOM recommendations. But they would not also be members of the governing board.

The IOM also said that CIRM should also revise its conflict of interest standards to regulate personal conflicts of interest, such as those involving particular diseases and patient advocates. Some members of the CIRM governing board bristled at the recommendation, and the board did not act on it last week.

Last Wednesday, the CIRM board acted to permit board members who are patient advocates to continue to participate in the closed door grant review sessions, but not vote on the grants at that stage. Previously patient advocates had two cuts at applications, one in the grant review group and one at the public board meeting.

Writing on the Daily Kos blog, Reed also said that no real conflicts of interest currently exist on the board, although 90 percent of the $1.7 billion that has awarded has gone to institutions tied to board members.

IOM's Shapiro Wants to See More Changes from California Stem Cell Agency

Additional mainstream media news coverage surfaced last Friday involving the California stem cell agency's response to the blue-ribbon report from the Institute of Medicine(IOM), whose concerns about the agency ranged from conflicts of interest to grant appeals by rejected researchers.

One of the more interesting pieces was done by Stephanie O'Neill of Los Angeles radio station KPCC. To her credit, she contacted the chairman of the IOM panel, Harold Shapiro, for his fresh take on what the stem cell agency's board did on Wednesday.

His comments were somewhat different than those read Wednesday at the CIRM board meeting. On Friday, Shapiro was quoted as saying the board action was “an important first step forward,” but he added a caveat. O'Neill wrote,

“'I’m encouraged by this,' Shapiro told KPCC. 'Presumably in the future they’ll take other steps. But these are steps they could take without any legislative approval and …I think it does respond in a pretty significant way to the spirit of the report.'
“But Shapiro expressed concern that the agency is making only 'small moves' to address a recommendation that CIRM separate operations from oversight. Currently, the ICOC functions 'both as an executor and as an overseer—competing duties that compromise the ICOC’s critical role of providing independent oversight and strategic direction,' according to the December IOM report.
“'But  I do understand… that would be a move that they would have to take over time so we’ll have to wait and see,' Shapiro said.
“Thomas agreed and said that while CIRMs recommendations more clearly define the roles of chairman and president, more refinements will be likely over time.”

From the Los Angeles Times, came a piece from Eryn Brown. Her article was brief and she referred her readers to the California Stem Cell Report for details. Her first paragraph said,

“Changes may be on the way at California’s stem cell funding agency.”

In coverage outside the mainstream media, the Burrill Report carried an article by Daniel Levine. The Burrill Report is produced by Burrill & Co., a San Francisco life sciences financial firm. Levine's straight-forward account was largely based on the CIRM press release and the IOM report.

Two bloggers surfaced with some coverage. UC Davis stem cell researcher Paul Knoepfler, who is a CIRM grantee, called the Thomas plan a “bold one-year experiment” and “biggest development for CIRM in many years.” Knoepfler said,

“I’m still not sure I’m a fan of all of the proposed changes, but I would say the plan is bold and creative.”

On livingbiology.com, an unidentified CIRM grantee carried a few brief items live from the meeting.

Stem Cell Agency Adds Fresh Details to IOM Response

The California stem cell agency today issued a press release touting “dramatic changes” at the agency in response to critical recommendations by the Institute of Medicine.

The press release contained a few more details about the changes than were released in the Power Point presentation yesterday. Here is the text of those details.

• “The 13 Board members appointed from institutions eligible for funding from the stem cell agency, such as those in the University of California system, would no longer vote on any grants brought before the Board but would instead abstain
• “All members of the Board would be able to participate in discussions on applications but only patient advocates and independent members of the Board would be able to vote on funding issues (members would continue to refrain from any discussion of specific applications from their institutions)
• “Patient Advocates would continue to be members of the Grants Working Groups but would not vote on individual applications
• “Programmatic review, aimed at balancing the agency’s portfolio, would take place at public Board meetings where members have a chance to make changes to recommendations from the Grants Working Group
• “Industry involvement would increase, where appropriate, on the Grants Working Group, and also feature in a newly constituted Scientific Advisory Board; the structure and membership of this group is still under discussion
• “Appeals on applications not recommended for funding will be handled by science staff who will evaluate them, determine if they merit further review by the Grants Working Group, and ultimately make recommendations to the Board. Staff will also be allowed to advocate for additional grants not recommended for funding by the Grants Working Group that they believe should be considered in programmatic review
• “The Chair and President would share a division of responsibilities with the President supervising all scientific operations and internal operational responsibilities. In addition the Chief Financial Officer would report to the President. The Chair would handle the ‘external affairs’ aspect of the agency, things such as financial sustainability to raise additional funds, state legislative relations, bond financing, public communications etc.
• “IOM recommendation on the creation of a Scientific Advisory Board to provide counsel on such issues as funding priorities and portfolio strategy will be implemented by staff
• “IOM recommendations on Intellectual Property will be referred to the agency’s IP subcommittee which will review and report back to the full board with options and recommendations
• “IOM recommendations on Sustainability: Chair, working with the President, will develop a plan to address this and present to the Board when ready

California Stem Cell Agency to Pitch Newspaper Editorial Boards

The California stem cell agency is planning an editorial road show with major California newspapers to explain its new plan to deal with the recommendations of the Institute of Medicine(IOM) for major changes at the agency.

In what might be called the kickoff to the campaign, the agency this afternoon issued a press release hailing the plan as making “dramatic changes.”

The agency could have a tough audience. The newspapers editorializing on the subject were unanimously in favor of the IOM recommendations. One said the agency needs to clean up its act. They warned of a loss of public trust along with losing the possibility of continued financial support. (For a sample, see here and here.)

CIRM Chairman J.T. Thomas said during today's meeting that a public relations foray was in the works following board action on his proposals yesterday. He said,

“The opportunity is ripe.”

His comments came after CIRM Director Jeff Sheehy, a UCSF communications manager, urged engaging the editorial boards.

Thomas' plan meets only a portion of the IOM recommendations and sidestepped a call for creating a new majority on the board of independent members. The IOM said “far too many” board members – at least 13 – are tied to institutions that receive money from CIRM. Thomas' plan would have the 13 voluntarily restrain from voting on any grants for any institution.

A compilation by the California Stem Cell Report shows that roughly 90 percent of the $1.7 billion awarded by directors has gone to institutions with links to the directors.  

Nature on the IOM and the California Stem Cell Agency

The journal Nature today said on its web site that the California stem cell agency plans to make a “few changes” in response to a critical report from the Institute of Medicine(IOM).

A short piece by Monya Baker on the agency's response yesterday summarized some of the IOM recommendations and the CIRM response. Baker wrote,

She said,

"Other IOM recommendations were only indirectly addressed by (CIRM Chairman J.T.) Thomas’ plan. The IOM report had stated that the board should restrict itself to an 'oversight' role rather than an 'operational' role. Thomas’s recommendations instead described ways to avoid overlapping duties. His own role as chair is to handle 'external affairs' whereas CIRM’s president will be to handle scientific and internal affairs."

Baker also carried the favorable comments from John M. Simpson of Consumer Watchdog.   

California Stem Cell Agency Overhauling Its Web Site

The governing board of the California stem cell agency adjourned its meeting today at 11:43 A.M. PST following a brief preview of its new web site. The changes are expected to be available online as early as tomorrow. Amy Adams, the agency's communications manager, said the changes are aimed at making the site more accessible and useful to all those interested in stem cell science.

Heart Disease Presentation at Stem Cell Board Meeting

The governing board of the California stem cell agency is hearing a presentation on pediatric heart disease by Deepak Srivastava of the Gladstone Institutes. The formal meeting is scheduled to resume following the presentation. However, there does not appear to be any major business remaining on the agenda.  Nonetheless, the California Stem Cell Report will continue to monitor the meeting for any developments worthy of note. 

Correction

Based on information provided by the California stem cell agency, two items on the California Stem Cell Report today and yesterday carried an incorrect tally, 21-0, on the vote on the plan to deal with recommendations of the Institute of Medicine. The correct figure is 23-0.

More Researchers Eligible for $100 Million Stem Cell Round

Directors of the California stem cell agency today expanded eligibility for the $100 million disease team round to include some earlier recipients in its early translational rounds.

Ellen Feigal, vice president for research and development, said some of those grantees are likely to be ready for more funding as they move closer to clinical trials. She said if they cannot apply in this round, they may have to wait for another year.

Directors agreed that it was important to avoid gaps in funding on successful programs. The RFA could be posted very soon.

Changes in $100 Million Disease Team Round

The disease team three item on the CIRM board's agenda is an alteration of  the original proposal approved in October. The round could total $100 million with awards of up to $20 million each. The agency has not yet posted information on exactly what is to be considered.