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.

Stem Cell Board Begins Meeting

The governing board of the California stem cell agency just began what is expected to be a brief meeting. On the agenda is a proposal for a third disease team round. The agency has already committed $436 million for disease team efforts, which are aimed at translating research into cures.

CIRM Director Pomeroy to Head Lasker Foundation

Claire Pomeroy, one of the original members of the governing board of the California stem cell agency, announced yesterday she has been selected as president of the Lasker Foundation for medical research and will be leaving the board.

In November, Pomeroy said she was resigning from her post as vice chancellor and dean of the medical school at UC Davis to pursue other interests.

Pomeory will assume her new position this spring. Here are links to the Lasker press release and a story in The Sacramento Bee.

Another Big Disease Team Round at California Stem Cell Agency

The California Stem Cell Report will provide live coverage of today's meeting of the governing board of the California stem cell agency. The board is expected to approve another round of its signature disease team grants. So far the agency has approved $436 million, 38 percent of its total funding, for two disease team rounds. The agency has not disclosed on the board agenda any information about the latest round, which could exceed $100 million. Previous disease team rounds have seen awards as high as $20 million each.

Roll Call Vote on the Thomas Plan Dealing with IOM Recommendations

Here is the roll call vote yesterday on the plan to deal with the findings of the Institute of Medicine concerning the California stem cell agency. The vote was 23-0 with one abstention. The board has 29 seats. Not all board members were in attendance, and it is not entirely clear whether all the board members in attendance voted. Among other things, the plan calls for members with links to institutions that could benefit from CIRM awards to voluntarily refrain from voting on any applications for funding – not just those to their institutions. The roll call was provided by a spokesman for the agency.

Yes votes

David Brenner, dean of the UC San Diego medical school.

Anne Marie Duliege , vice president of Affymax

Michael Freidman, CEO City of Hope

Michael Goldberg, executive chairman of Nodality, Inc., and DNAnexus, appointed as executive officer of a commercial life science entity

Sam Hawgood, dean of the UC San Francisco medical school

Steve Juelsgaard, former executive vice president of Genentech, appointed as executive officer of a commercial life science entity

Sherry Lansing, chairwoman of the UC board of regents, appointed as patient advocate

Jacob Levin, assistant vice chancellor, research, UC Irvine, and alternate for Sue Bryant, interim provost at UC Irvine

Bert Lubin, CEO of Childrens Hospital, Oakland

Robert Price, associate vice chancellor for research, political science professor, alternate for the UC Berkeley chancellor

Francisco Prieto, Sacramento physician and patient advocate member of the board

Robert Quint, San Jose physician and patient advocate member

Duane Roth, San Diego businessman, appointed as executive officer of a commercial life science entity

Joan Samuelson, patient advocate member

Jeff Sheehy, patient advocate member

Jon Shestack, patient advocate member

Os Steward, patient advocate member and head of the Reeve-Irvine Research Center at UC Irvine

Jonathan Thomas, chairman of the board and Los Angeles bond financier

Art Torres, patient advocate member

Kristiina Vuori, interim CEO of Sanford Burnham Research Institute

Diane Winokur, patient advocate member
Claire Pomeroy, dean of the UC Davis medical school
Shlomo Melmed, senior vice president for academic affairs, Cedars Sinai

Abstaining

Michael Marletta, CEO of Scripps Research

(Editor's note: Based on information provided by CIRM, an earlier version of this item incorrectly reported that the vote was 21-0. It also contained errors on three names. All have been corrected. Thanks for the heads up on the misspellings from a board member who will remain unnamed.)

Meager, Meager Coverage of Yesterday's IOM-Stem Cell Meeting

The $3 billion California stem cell agency seemed all but invisible this morning in terms of mainstream media coverage.

Only one major outlet reported on the watershed events yesterday at the CIRM governing board meeting at the Claremont Hotel in Oakland – at least from what our Internet searches show.

The piece was written by Bradley Fikes in the San Diego U-T, the dominant daily newspaper in that area, which is a major biotech center. The major media in the San Francisco Bay area, home to the stem cell agency and also a biotech center, were absent from the coverage.

Fikes wrote a straight forward account of the meeting, saying that the governing board voted “ to accept in concept proposed changes to reduce conflicts of interest on the agency's governing committee.”

Fikes wrote the story based on the audiocast of the meeting. He probably would not have written his daily piece without the availability of the audiocast. 

Some of those connected with the stem cell agency often wonder about the lack of mainstream coverage of its doings, particularly the lack of favorable coverage.

Much of it has to do with the shriveled state of the media business, which is understaffed and overworked compared to 15 years ago. Specialized science reporters are all but an extinct species. Also, the mainstream media has traditionally ignored the affairs of most state agencies.

Speaking as a former editor at a major Northern California newspaper, I would not have sent a reporter to cover this week's two-day CIRM board meetings. It would have consumed too much valuable time with little likelihood of a major story, especially when weighed against other story possibilities. There was no guarantee that the board would have even acted. The events and their significance could be better handled in a roundup story later with more perspective, perhaps keying on the board's meeting in March, where details of yesterday's action will be fleshed out. The fact is that many, very important events occur within state government every day that never receive media attention. Some don't even see the light of day until a catastrophe occurs.

All of this may be deplorable in the eyes in stem cell agency backers and others, but it is the reality of today's news business.  

Reaction to IOM: California Stem Cell Directors Approve Plan on Conflicts of Interest and More

Directors of the $3 billion California stem cell agency today approved a far-reaching plan aimed at resolving long-standing conflict of interest issues involving the agency's governing board and also at helping to maintain credibility with the public.

Jonathan Thomas
CIRM photo

The framework of the proposal by CIRM Chairman J.T. Thomas moved forward on a 23-0 vote with one abstention. He laid out the plan in response to sweeping recommendations from a blue-ribbon study by the Institute of Medicine. Details will be worked out and come back to the board in March. 

Acknowledging that many board members were not pleased with the IOM criticism of the agency, Thomas said, 

“This is one of those times that we must move forward and compromise.” 

He said issues such conflicts of interest have “stolen focus” from the good scientific work that the agency has funded.

Thomas was reacting to the $700,000 IOM study commissioned by CIRM governing board. The IOM recommendations called for removing conflict of interest problems, cleaning up a troubling dual-executive arrangement and fundamentally changing the nature of the governing board. The IOM proposals would strip the board of its ability to approve individual grants, greatly strengthen the role of the agency's president, significantly alter the role of patient advocates on the governing board and engage the biotech industry more vigorously.

Thomas' plan, which would be put in place for up to a one-year trial period, would not do all that the IOM wanted, but would move strongly in that direction.

State Controller John Chiang, chairman of the only state entity with financial oversight over CIRM, endorsed most of the proposal, said deputy controller Ruth Holton-Hodson. She told CIRM directors that Thomas' plan was thoughtful and positive, although Chiang did not support continued involvement of the chairman in day-to-day operations.

The Thomas plan, which would not require legislative approval, would:

• Have 13 members of the 29-member board refrain from voting on specific grant applications. The 13 would be from institutions that could benefit from CIRM grants. They would be allowed to participate in discussions. Thomas said this would deal with financial conflict of interest questions. 
• Increase industry participation of industry in grant application review and step up business involvement internally at CIRM, including development of RFAs.
• Redirect all scientific appeals to staff to evaluate for possible re-review before they go to the full board.
• Move “programmatic” review of grants to public sessions of the full board instead of being held behind closed doors during grant review sessions. Patient advocate directors now sitting on the grant review group would no longer be allowed to vote during the closed-door review sessions, but they could participate in the discussion.

It appears, however, that the Thomas plan would do little to deal with the dual-executive problems identified by the IOM.

Consumer Watchdog's John M. Simpson, a long observer of the stem cell agency, welcomed the response by CIRM. Writing on his blog, Simpson said,

 "It looks like the message is finally getting through to California's stem cell agency board....
Part of what is driving the new approach is the realization that CIRM will need to find a new source of funding -- possibly going back to the voters -- if it is to continue.  As Thomas told the board today, 'If we don't have credibility, we won't have a chance of sustaining the agency.'"

During the lengthy debate this afternoon, one director after another said they did not agree with all that the IOM had to say, but said maintaining credibility and trust was the key to the sustainability of the organization.

CIRM will run out of money for new grants in less than four years. Thomas said he is working on a plan to continue the agency's effort into the future. Details of that will be disclosed later, he said.

(Editor's note: An earlier version of this item, based on incorrect information from CIRM, said the vote was 21-0. The correct figure is 23-0.)

California Stem Cell Agency Directors Approve Changes to Meet IOM Recommendations

The board of the California stem cell agency has adjourning following approval of the Thomas plan to deal with recommendations of the Institute of Medicine for changes at the agency. More details shortly.

Vote Nearing on Thomas Response to IOM Recommendations

The governing board of the California stem cell agency appears to be heading for a vote on the Thomas IOM plan, which he has agreed to place on a one-year test timetable. The plan is being described as a "framework" with details to be worked out. The proposal would be fleshed out and come back to the board in March for later action. Several board members have raised questions about the details. But Thomas and other supporters say those will have to be worked out.

Consumer Watchdog Welcomes Changes at Stem Cell Agency

Consumer Watchdog's John M. Simpson today welcomed the response by CIRM 

Chairman J.T. Thomas to address the recommendations for sweeping changes at the California stem cell agency. 

Writing on his blog, Simpson, a longtime observer of the agency, said, 

"It looks like the message is finally getting through to California's stem cell agency board....
"Part of what is driving the new approach is the realization that CIRM will need to find a new source of funding -- possibly going back to the voters -- if it is to continue.  As Thomas told the board today, "If we don't have credibility, we won't have a chance of sustaining the agency."

Thomas' IOM Plan Receiving Generally Positive Response

So far,  many of the directors of the $3 billion California stem cell agency today seem to be endorsing the plan proposed by Chairman J.T. Thomas to meet the sweeping recommendations by  the Institute of Medicine.

Several members stressed the need to remove the perception of conflicts of interest on the board, as identified by Institute of Medicine and other studies of the stem cell agency.  Concerns about conflicts of interest go back as far as the election in 2004 when the plan to create the stem cell agency was presented to the voters of California.

Director Sherry Lansing, who is chair of the UC Board of Regents, said "we can't fight" the perceptions any more. She said the board needed to move forward and control its own destiny instead of having to deal with possible legislative changes. Continued perception issues "will harm our work," she said.

However, a couple of other members expressed some dissent.

Among other things, Thomas' plan would require 13 members of the board not to vote on individual grants, although they could take part in debate on them. The 13 are members who are linked to institutions that are likely recipients of CIRM awards. All of the changes proposed by Thomas could be done without legislative action, he said. Thomas also said that chairman of the IOM study panel endorsed his plan, saying it would serve the best interests of the people of California.

According to compilations by the California Stem Cell Report, about 90 percent of the $1.7 billion awarded by CIRM has gone to institutions with ties to members of the CIRM board.

Here is a link to the Power Point presentation of Thomas' plan.