A Matter for CIRM to Ponder: California's Visceral Reaction to High Salaries for Public Servants

Lavish government or quasi-government salaries are an anathema to California voters.

They reacted predictably with outrage last week when news surfaced about what they considered egregious greed. Jail time was urged. “Nauseating” was another word that was used.

The response is something to be considered by directors of the California stem cell agency, which has its own set of generous executive salaries. What is important here is what the voters perceive as lavish or greedy – not the perceptions of recipients or the perceptions of those who approve the pay.

One non-CIRM instance involved the city of Bell, a tiny, not particularly well-off enclave not too far south of downtown Los Angeles. It was there that the city manager resigned after it was disclosed by the Los Angeles Times that he was earning $800,000 a year. And that left him with a pension estimated at $600,000, going on $700,000. Times columnist Steve Lopez wrote,

“The sad reality, dear Californian, is that depending on where you live, you may be personally contributing to the insultingly fat pension of ousted Bell city administrator Robert "Ratso" Rizzo.”

The other instance involved the executive director of the non-profit California School Boards Association, which is based in Sacramento and supported by tax dollars that are paid to the association by school boards. The executive, who is mostly a lobbyist, retired after Sacramento television station KCRA disclosed that he made more than $540,000 two years ago, the most recent figure available.

“Piggies,” “unconscionable,” “retire him to the county jail” were some of the 129 comments filed on a Sacramento Bee story about the matter.

The salary scale at the $3 billion California stem cell agency tops out at more than $500,000. Amounts paid to its top executives have triggered harsh comments from a handful of observers. CIRM's contracts with outsiders have also been targeted. But the pay and contracts have received no widespread notice.

A good case can be made that the salaries at the highest levels of the stem cell agency are necessary and appropriate. But that makes little difference to citizens struggling with layoffs, cutbacks and wage roll backs. Even before the current dismal economic climate, they would froth and foam reflexively at what they regarded as excessive pay for public servants.

As CIRM aims at another pitch to the voters for billions more for research, its directors and executives should be preparing for a visceral and emotional outburst from citizens concerning its executives' pay.

CIRM Defends Legality of Barring Public From Marriott Meeting

The California stem cell agency says it did not violate state open meeting laws when it barred two members of the public from a meeting in June at a San Francisco hotel.

In an unsolicited note earlier this month to the California Stem Cell Report, Ian Sweedler, deputy legal counsel for CIRM, said,

“The Bagley-Keene Open Meeting Act applies to multimember boards or commissions, like the ICOC (CIRM directors) and its subcommittees, not to agency staff, or to other meetings that staff attend or organize in the operation of the agency, including the SCNT workshop.  We are always mindful of Bagley-Keene, and careful to follow it when it applies.”

We asked him to clarify his response, including whether CIRM's actions in this case violated recent changes in the California Constitution that guarantee the public a broadly construed right to information about the taxpayer's business.

Sweedler said,

“Sorry if I wasn’t clear.  Yes, I am stating, without qualification, that the SCNT workshop did not violate Bagley-Keene or Proposition 59(the change in the state Constitution), or any other law that I am aware of.  You had stated that a specific CIRM activity violated a specific law, and I thought it was important to correct that.  Thanks.”

We understand and respect Sweedler's opinion. However, it would take a court decision to determine whether he is correct. Our research indicates that a strong case can be made that such meetings must be open. Additionally, the state's open meeting laws were written well before CIRM, an agency unlike any other in state history, came into being. They must be reinterpreted not only in the wake of the Prop. 71 but also in the wake of a new, much broader constitutional guarantee of right of public access. The most important point, however, is that CIRM has pledged to go beyond the mere compliance with open meeting laws. As we noted earlier,

“Legalities aside, it is not in CIRM's best interest to bar persons from any of its sessions – not to mention that it is not in the best interests of the people of California. CIRM needs to do more than meet the minimum standards of the state's sunshine laws. To fail to do so will create a record that will surely harm CIRM's public support and hamper its efforts to secure more funding after it runs out of the $2 billion it has left to spend.”

As to whether CIRM adhered to the law, Sweedler confirmed that the meeting in question included the attendance of at least one alternate for a CIRM director, Jeannie Fontana. We also understand that some persons were in attendance who had not been invited directly by CIRM.

Those facts have an impact on whether the ban on the public is strictly legal. The First Amendment Coalition of California watches over the application of sunshine laws in California. The group says,

“California law doesn’t exactly ban deal-making by politicians in smoke-filled rooms, but it comes close to doing that at the local level (under the Brown Act) and among state agencies (under the Bagley-Keene Act). The fundamental idea behind these statutes is that the full process of political deliberating and decision-making—justly likened to the making of sausage—should be conducted in the open, in public meetings for all to see. Although the laws allow for certain matters to be considered in 'executive session,' they are the rare exception (in theory, at any rate).”

The coalition's Web site discusses cases (see here, here and here) that have application concerning the incident at the Marriott Hotel. They deal with the presence of a board member (or alternate in this case) at meetings such as those held by CIRM, as well as the possibility that they could lead to an illegal “serial meeting” of the CIRM board of directors even if only CIRM staffers were involved at the initial meeting.

In one case involving local open meeting laws, the First Amendment Coalition quoted the state attorney general as saying,

“In construing these terms, one should be mindful of the ultimate purposes of the Act — to provide the public with an opportunity to monitor and participate in decision-making processes of boards and commissions.  Conversations which advance or clarify a member’s understanding of an issue, or facilitate an agreement or compromise among members, or advance the ultimate resolution of an issue, are all examples of communications which contribute to the development of a concurrence as to action to be taken by the legislative body.”

In other words, such meetings should be open to the public.

Sweedler's statements go beyond CIRM's earlier comments. The stem cell agency previously contended that the meeting was closed to protect proprietary information, but failed to argue that open meeting laws did not apply. Don Gibbons, CIRM communications chief, said the meeting was designed “to gather information for critical decisions regarding the direction our funding should take.” To us, that sounds like something the public should have access to.

CIRM has virtually nothing to gain by barring the public. It is not as if hoards will descend on the sessions. Even full CIRM board meetings rarely attract more than 10 members of the public. Indeed, the agency is likely to benefit from comments that come from a different angle.

Correction

In two recent items, we misspelled the last name of a Duke University researcher. The correct spelling is Rob Wechsler-Reya. We had it incorrectly as Weschler.

Questions and Commentary on Stem Cell Reprogramming

The California stem cell agency and a UC Davis stem cell researcher are blogging on the implications of research that indicates that reprogrammed adult stem cells may not be the magic bullet that avoids the problems associated with human embryonic stem cells.

You can find a summary of some of the research and discussion from CIRM's Amy Adams here. Paul Knoepfler of UC Davis said,

"So if iPS cells are not that similar to ESC, what does this mean?

"First, it is not the end of the world. Many of us had assumed that iPS cells are similar to ESC in some ways, but distinct in others. These studies simply validate that notion.

"Second, iPS cells are still very useful even if they are not quite so close siblings of ESC. In fact, iPS cells do not need to be extremely similar to ESC to be useful. The pluripotency and self-renewal of iPS cells makes them a powerful tool regardless.

"Third, iPS cells are a distinct type of stem cell from ESC and should be considered as such.

"Fourth, these studies also highlight that every iPS cell line made is distinct from the others made. The heterogeneity amongst iPS cell lines is probably more substantial than the differences between ESC lines, but ESC lines also vary between each other quite a lot as well.

"Finally, the tumorigenicity of iPS cells is a serious concern. A remaining open question is how prone iPS cells are to form malignant tumors (although don't forget that teratoma can be malignant!). We predict that iPS cells are dramatically more prone to produce malignant tumors compared to ESC."

(Editor's note: An earlier version of this item contained typos in the material that was inserted from Knoepfler's original post. He corrected those typos on his blog, and we have altered his quote above to reflect those changes.)

Day 153 of the Wechsler-Reya Affair: Near Silence from All Quarters

California's $6 million, long-running courtship of a pair of Duke Blue Devils has apparently not been consummated.

But, like many other consummations, it is not easy to tell. Silence is the watchword on the part of those who know.

Last April, the California stem cell agency offered a $6 million signing bonus to Robert Wechsler-Reya, a researcher at Duke University, to move to La Jolla's Sanford-Burnham Institute. The award is part of a two-year, $44 million taxpayer-financed effort to help recruit scientists to California.

Sanford-Burnham is also providing “an extremely generous commitment of laboratory space, matching funds for equipment, additional support for relocation and research, and access to excellent core facilities,” CIRM grant reviewers said.

But the multimillion dollar enticement did not make the Duke pair jump with alacrity. Wechsler-Reya told the California Stem Cell Report last spring he had not made a decision. That situation seems to be unchanged today.

On Monday, we queried Wechsler-Reya about whether he and his wife, Tannishtha Reya, also a stem cell researcher, will take their work to Sanford-Burnham. So far he has not responded. CIRM remains mum as well, failing to answer our questions from Monday.

Andrea Moser, vice president for communications at Sanford-Burnham, however, did say something.

“At the current time, we do not have an update on the Wechsler-Reya recruitment.”

In April, the $3 billion stem cell agency tried to impose a June 30 deadline on the courtship. CIRM President Alan Trounson told directors that Sanford-Burnham had assured him the deal would be done by then.

One reason that directors wanted the matter settled was competition for more of the signing bonus cash. If the Duke researcher was not coming to California, more money would be available to help other institutions lure scientists to the Golden State. CIRM reviewers held a closed-door session last week to make decisions on those applications, but no news was forthcoming from that event.

So we are now into Day 153 of the Wechsler-Reya Affair. Stay tuned for all the developments.

(Editor's note: We started counting the days beginning with the Feb. 18 application deadline for the grant.)

(Wechsler-Reya photo)

Stem Cell Directors Postpone Action on Troubled Appeals Process

Directors of the California stem cell agency today delayed action on moves to reshape the “broken” grant appeal process at CIRM.

In response to a query about the outcome of the directors' Science Subcommittee, Don Gibbons, chief of CIRM communications, said,

“A lengthy discussion resulted in agreement to continue the discussion rather than take action at this time. It was generally agreed that any re-scoring request from the board should be a rarely used option.”

CIRM's board of directors has been bedeviled by problems with the appeals process for 2 1/2 years. The directors' new Science Subcommittee began to address the issue late in May.

More details on the directors' thinking on the problem will have to await the unveiling of the meeting transcript in about two weeks.

Biopolitical Times Questions Rationale for Future CIRM Funding

The case that California stem cell Chairman Robert Klein is trying to make for more funding for the $3 billion research effort rings hollow, according to the Center for Genetics and Society.

Writing on the group's Biopolitical Times blog, Jesse Reynolds, the Berkeley center's project director on biotechnology accountability, said that another ballot measure for stem cell research would fail. He said,

“...(I)nstead of the promised cures of the Proposition 71 campaign, reality-based voters see dramatic cuts in the state's essential services, liberalized federal funding of embryonic stem cell research, and a potential alternative in cellular reprogramming.”

Reynolds made his comments in the wake of a cover story in the San Francisco Examiner about the state of CIRM. Reynolds wrote that Klein “unsurprisingly defends its continued funding.”

Reynolds continued,

“But Klein’s arguments ring hollow. First, he cites an economic study that concludes the program has generated significant tax revenue. But that study's conclusions were controversial, and in any case $100 million is far less than the billion dollars the CIRM has already spent. The program is certainly not paying for itself, as he suggests now and as he claimed before the vote on Proposition 71.

“Second, Klein cites reduced health care costs. He goes so far as to say, 'First of all, we’re saving lives.' While I sincerely hope that embryonic stem cell research leads to therapies, that is not yet the case. Clinical trials are yet to begin. (Maybe next year?) Until there are genuine therapies, such savings remain hypothetical.”

CIRM Seeks Communications Coordinator

The California stem cell agency is still looking for a “communications outreach coordinator” to help beef up its public relations efforts.

The agency has re-posted the RFP for the $85,000, 12-month job after apparently not being satisfied with the earlier round of applicants. The part-time position also includes a $10,000 travel budget. The winning applicant will be expected to work 20 to 30 hours a week.

Among the responsibilities for the position are three CIRM town forums, Stem Cell Awareness Day, relations with patient advocacy groups and assistance in developing material for use in advocacy group meetings.

Deadline for applications is July 30.

UC Davis Scientist Praises CIRM Appeals Change

A stem cell researcher at UC Davis today said a change in the CIRM grant appeals procedure makes “a lot of sense.”

Writing on his blog in regard to "extraordinary petitions," Paul Knoepfler said,

“I think the proposed change makes a lot of sense and would greatly improve the process. Sometimes the reasons in the petitions are clearly not meritorious and as it now stands, they end up wasting CIRM's time. The last time CIRM received 9 petitions as well, which represented a remarkably large fraction of the total applications. A stricter process would discourage the submission of large numbers of petitions, an important issue given that the number of petitions received by CIRM continues to grow.

“As someone who has submitted dozens of grant applications over the years to many different funding agencies, I know how it feels to get applications unfunded and receive critiques I may not agree with. It is not fun. It is especially difficult when one is near but below the funding cutoff. However, it happens all the time.

“I think CIRM might consider a bit stronger language in their policy on appeals making it clear that appeals should only be filed in very limited circumstances and that appeals found to be without merit will be frowned upon.

“In other words, don't file an appeal simply because the rules theoretically allow you to and/or you are grumpy about how your grant application was received. Such frivolous appeals may affect your reputation.”

Knoepfler also received a comment from Jeff Sheehy, chairman of the CIRM Science Subcommittee, which will be considering the changes. Sheehy said,

“One thing that I think confuses folks is the lack of control we have over what comes to the Board.  As a public body, we're governed by State open government-Bagley-Keene rules (which I strongly support, btw).

“On any matter under consideration by the Board, any member of the public can speak to the matter or provide documents to Boardmembers.  Within that legal reality, we can only channel and not reject 'extraordinary petitions.'”

Whither Wechsler-Reya? A $6 Million Stem Cell Tale

Is a high-flying stem cell researcher from Duke coming to California to claim his $6 million grant from the state's $3 billion stem cell agency?

Can the prestigious Sanford-Burnham Institute in tony La Jolla, Ca., lure him and his wife away from their spots at the Gothic Wonderland, as Duke University is sometimes known?

The answers to these and other questions are still a mystery despite a quasi-deadline for the giveaway imposed by the 29 directors of the Californa Institute for Regenerative Medicine.

The will-they or won't-they matter involves Robert Wechsler-Reya and Tannishtha Reya, another Duke researcher.

The couple is being or has been recruited by Sanford-Burnham with the help of the multimillion dollar grant from California taxpayers. Directors of the state stem cell agency approved the award in April.

At the time, directors appeared to be initially unaware that the deal was not done. Wechsler-Reya told the California Stem Cell Report that he had not made up his mind on whether he would become a latter-day California argonaut.

According to the transcript of the April 29 CIRM board meeting, Chairman Robert Klein said he wanted a “definitive time” for conclusion of the Wechsler-Reya recruitment. CIRM President Alan Trounson said that Sanford-Burnham said it would be finished by the end of June. He told directors,

“We're reassured that that will be the case.”

Sanford-Burnham has announced other hires this month, but did not mention the Duke researchers. Earlier this month, we asked CIRM about the situation.

Amy Adams, communications manager for the agency, replied on July 1,

“The deadline in the RFA is for funding to start within six months after ICOC approval. At the ICOC meeting, there was agreement that it would be desirable to know Dr. Wechsler-Reya's decision before the next review so that we know how many slots remain, and the hiring institution agreed that would be reasonable. It was also stated that we hoped to have the recruitment resolved by the end of June, which has not happened.”

Wechsler-Reya has not responded to a request for comment. We are asking both him and CIRM again about the matter.

CIRM Finally Discloses Grant Appeal Proposals

The California stem cell agency early today belatedly posted a two-page memo on proposed changes in how it will deal with appeals by scientists whose grant applications have been rejected by reviewers.

The information comes only one business day before a meeting of the CIRM directors' Science Subcommittee to consider alterations in the appeals process. The changes deal with an issue that has been publicly troubling the CIRM board for 2 1/2 years. Many CIRM directors are unhappy with a situation that finds researchers publicly appearing before the board to press their cases. One director has described the process as “broken,” a description that others would likely use.

One proposed change provides for “re-scoring” of applications when directors are unable to make an "informed decision" at the board meeting at which an application is considered. The re-scoring would occur when “a material dispute of fact exists or when new information that is not available at the time of the initial review has come to light.”

The staff memo said,

“Programmatic issues, such as whether the agency’s portfolio is well-balanced among diseases, should not be a justification for re-scoring, nor should clear errors in the review of an application that have been identified by staff and presented to the board.”

Other changes would stipulate that CIRM staff would not respond in writing to the board on “extraordinary petitions” unless they believe the petition has merit.

Applicants would be advised that they may submit a petition – which is tantamount to an appeal – five days before the CIRM board is to consider their application “if they believe a material error or omission in the review of their application may have affected the recommendation made by the Grants Working Group to the board.”

Staff summaries of reviewers' recommendations would also cover the “majority views and the minority views, when there is a major difference of scientific opinion between large blocks of reviewers (e.g. eight speaking against and five in favor).”

As we have noted, it is a dismal commentary on CIRM that it has taken the agency until now to post the two-page document on the proposed changes. The agency cannot expect well-considered comments or questions from the hundreds of affected California scientists when it discloses information only one business day prior to the meeting at which a matter is to be considered. Indeed, we suspect that most California stem cell researchers are not even aware that CIRM is considering changes tomorrow that could affect their livelihood and work. That is not to mention that CIRM's belated posting does not come close to meeting the pledge of CIRM Chairman Robert Klein that the $3 billion research effort will adhere to the highest standards of openness and transparency.

Sticky, Troubling Appeals by Rejected Researchers Targeted by Stem Cell Agency

A key step in the process for awarding billions of dollars in research grants is “broken,” according to many directors of the California stem cell agency, and major changes are looming that will affect hundreds of scientists.

Just what those changes are likely to be is unclear. The stem cell agency has not made available to the public any drafts of likely proposals or other related material for a meeting on the matter that begins in only one business day. The only information on the agenda for the directors' Science Subcommittee says: “consideration of changes to extraordinary petition and grant administration appeals processes.”

(Editor's note: Hours after this item was posted, CIRM added material to its agenda that outlined the proposed changes. You can find more on the plan here.)

Nonetheless, specific proposals are virtually certain to come out of the session. Those would then go to the full board meeting on Aug. 18 for ratification and perhaps modification.

Many CIRM directors have long been uncomfortable dealing with public appeals by applicants rejected by the agency's grant review group. On the first such occasion in January 2008, Gerald Levey, a CIRM director and then dean of the UCLA Medical School, said, "I don't think we can run a board this way. If we do, it would be chaos."

Eight months later, directors approved the use of “extraordinary petitions” by applicants. However, that has not eased the situation. Last month directors were hit with a record nine petitions and overturned negative decisions by reviewers on four grants, also a record.

The Science Subcommittee first dealt with the appeals process on May 25. According to the transcript, the panel's chairman, Jeff Sheehy, a patient advocate and communications manager at UC San Francisco, said during the brief discussion,

“This is a broken process. I think almost everybody on the board would agree that it is.”

Duane Roth, co-vice chairman of the CIRM board and a San Diego businessman, said,

"This is one that I think really needs to be rethought completely because what we have right now doesn't seem to be working. Even the extraordinary petitions, I think with the exception potentially of one which we responded to, we agreed with the reviewers. And then in the board meetings turned around and disagreed with our own disagreement. And I think we just don't want to do that.

"Second, I think we're inviting very bad precedent behavior by opening ourselves up to the kinds of things that we went through at the last meeting. We just invite people to continue to do that. I'd like to see us find a solution for grievances on the reviews that everybody can get behind and endorse and embrace."

Among the suggestions in May was one from Sheehy to create a “re-review” option. Facing an appeal, directors could send an application back to the review group for re-evaluation in the light of comments from an applicant. CIRM directors almost certainly already have that authority although it has never been used or formally articulated. Prop. 71 makes the CIRM board the final arbiter on applications. Directors can do anything they want with an application. In practice, however, the grant review group makes the de facto decisions with the board intervening in only a tiny percentage of cases.

Sheehy, who is also a member of the grants review group, additionally said he would like the bifurcated appeal process consolidated. Currently, an “appeal” can only be made on the grounds of a conflict of interest. However, those reviews are done behind closed doors and applicants do not know the identity of reviewers charged with close evaluation of their proposals. Conflict appeals are handled privately by CIRM staff and do not normally come before the full board. Extraordinary petitions are technically not appeals, according to CIRM, but in reality serve that purpose.

Complicating the whole matter is the fact that any scientist or member of the public can speak directly to the board at its meetings on any matter, including rejection of applications. They can also write or email the directors. That is a matter of law and cannot be changed by CIRM rules.

At the May subcommittee meeting, CIRM President Alan Trounson discussed the public appearances of researchers. He said,

"It makes it very difficult on the spot to try and provide the board with the kind of information that they need."

Trounson also said the schedule for petitions is tight and comes only days before a board meeting, making it difficult for CIRM staff to evaluate the issues that are raised. However, some petitions are being presented to the board even though they have not met the deadline for submission.

Art Torres, co-vice chairman of the board and a former state lawmaker, suggested that applicants sign a document stating that they have read the rules for filing petitions. CIRM Chairman Robert Klein concurred with that suggestion.

Whatever comes out of Tuesday's meeting, it is a dismal commentary on CIRM that it cannot or will not provide timely information to the public and its stakeholders about how it plans to handle this portion of $3 billion in taxpayers' business.

Here is a link to a reading list, prepared by the California Stem Cell Report, of articles and CIRM documents on appeals and extraordinary petitions.

New CIRM VP Lewis and Ambit Biosciences

The new, part-time interim vice president for research and development at the California stem cell agency, Alan Lewis, also is executive chairman of Ambit Biosciences, a privately held biotech firm in San Diego. That information was not included in CIRM 's news release on his role at the agency.

We asked Lewis by email about his work at Ambit and told him we would carry his responses verbatim. He responded directly and quickly. Here are the questions and his answers.

California Stem Cell Report (CSCR): When did you become executive chairman of Ambit?
Lewis: “Approx May, 2010."

CSCR: What responsibilities does that entail?
Lewis: “It is similar to being board chair except Ambit is seeking a new CEO so I am the 'sign off' person who speaks once a week to three key staff. Also responsible for helping to create board agendas, and I am a member of the compensation committee.”

CSCR:Is the position compensated? If so, how much?
Lewis: “Typical of biotech boards--approx $25k/year. This consists of an annual fee plus board meeting fee.”

CSCR: Do you plan to continue as executive chairman while you are serving as interim VP at CIRM?
Lewis: “Yes. It involves approx five meetings per year in San Diego, and will have less responsibility as soon as the new CEO joins, probably mid-later July this year.”

CSCR: Do you see any conflicts of interest of any sort involving CIRM and your role at Ambit?
Lewis: "No. Ambit has no interest in regenerative medicines or cancer stem cells. They are focused on kinase inhibitors for cancer and inflammatatory diseases.”

CSCR: Were you a candidate for the VP position as a fulltime employee at CIRM?
Lewis: “No.”

CSCR: Do you plan to seek any other position at CIRM or on the CIRM board in the future?
Lewis: “Not given this any thought – probably not.”

Correction

On July 2, we incorrectly reported that the consulting contract CIRM has with Alan Lewis was not mentioned at the June meeting of the governing board of the California stem cell agency. Our apologies to CIRM President Alan Trounson for getting this wrong. In fact, Trounson announced that Lewis would serve as a consultant two or three days a week.

Here is the text of what Trounson told the board, according to the transcript.

“We're having difficulties in that area(selection of a vice president for research and development), difficulties in attracting someone because of the high salaries of these very competent people in the industry to join us. So we're still in research mode at the moment, but I should let you know that Alan Lewis, who just stepped down from the Junior Diabetes Research Foundation, is going to join us as a consultant to work two or three days to help us with the clinical, preclinical programs. He's a terrific guy. I think most of you would know him. And he's agreed to become a consultant for the time being while we're still in search mode.”

Appeals on Stem Cell Grant Applications: CIRM's Upcoming Re-examination

If researchers want to be successful at winning some of California's stem cell billions, they should set aside time this month to consider or comment on likely changes in policies that will affect their livelihoods.

The California stem cell agency is re-examining the process by which scientists can appeal negative decisions by reviewers on their applications for grants and loan. This reaches beyond academia and affects business applicants.

Little is known at this point about exactly what the agency is proposing to do. The July 20 meeting of the directors' new Science Subcommittee was just announced this weekend, and no background information has been posted. CIRM has two processes involving appeals: extraordinary petitions and “normal” appeals, which are based only conflict of interest issues.

CIRM directors have long expressed exasperation with the appeals process. In fact, they created the extraordinary petition procedure to deal with the issue. A host of articles dealing with the appeals process can be found on the California Stem Cell Report by searching on the terms “extraordinary petitions” and “appeals.”

If researchers or the public cannot make it to the teleconference locations for the meeting, they can send their comments by email to the agency (mking@cirm.ca.gov).

Also on the agenda is consideration of commissioning an Institute of Medicine study of CIRM and a plan to add funds to the new clinical trials grant round, now slated for $50 million. The clinical trials RFA is scheduled to be posted this month and is likely to involve a firm whose financial backers pumped nearly $6 million into Prop. 71, which created the stem cell grant program.

Teleconference locations for the meeting can be found in San Francisco(2), Duarte, Irvine (2), Healdsburg, Stanford, Palo Alto and Pleasanton. Specific addresses are on the agenda.

Klein Defends Burgeoning CIRM Budget

The San Francisco Examiner today published a couple of stories focusing on how the $3 billion California stem cell agency is immune to the budget pressures that face the rest of the financially troubled state.

Katie Worth wrote,

“...(N)ary a paper cut has injured the budget of the state-funded California Institute for Regenerative Medicine.

“In fact, last month, the 5-year-old agency’s largest operating budget ever was approved. Its out-of-state travel budget will more than double this year. Later this year, agency leaders hope to receive a legislative OK to expand the staff beyond the voter-mandated limit of 50 employees. The agency just hired a new vice president on a part-time basis: He will work about 24 hours a week for six months, and be paid $250,000.

“The agency chairman (Robert Klein) said all of these expenditures are justified because the research the agency has funded is well on its way to saving lives. In fact, he said once the current unbroken flow of cash begins to slow, the agency will be able to make a strong case to voters that they should fund even more research.”

SF Lawyer Urges Openness at Stem Cell Agency

Writing in connection with an incident in which two persons were barred from a CIRM meeting, a San Francisco attorney this week called on the California stem cell agency “to return to its commitment to an open and public process.”

Justine Durrell, who is involved in issues dealing with biotech and women's health, made the comment in a three-page letter to the 29 members of the board of directors of the $3 billion research effort. Her letter referred to the item last month in the California Stem Cell Report describing the incident at a San Francisco hotel.

Durrell raised a series of question in connection with the meeting and its implications for procurement of human eggs. Among them were the absence of public notification about the meetings, the justification for exclusion of the public and CIRM's lack of funding for research into the health consequences on women who provide eggs for research.

She wrote,

“Additionally, I emphasize the importance of CIRM's return to its commitment to an open and public process. In the end, openness and transparency will better serve all Californians. Please obviously post in advance all meeting times and locations, the agenda, whether they are open or closed (the justification therefore), and the transcripts/minutes/reports following the meeting.”

You can read Durrell's entire letter here.

Open Meeting Letter -- Justine Durrell to Stem Cell Board

Campaign Contributors, iPierian and the California Stem Cell Agency

Major contributors to the Prop. 71 campaign are pumping more of their own cash into a South San Francisco stem cell firm that has received $1.5 million from the state agency that they helped to create in 2004.

The firm, iPierian, Inc., also has plans to seek additional millions in the near future from the California stem cell agency. The new venture capital funding round announced by the firm today may well be tied to that application.

Ipierian's news release additionally disclosed major new support from another enterprise tied to a Prop. 71 campaign contributor. Ipierian said Google Ventures had joined the firm's backers in the $22 million funding round. Google Ventures will get a seat on the iPierian board as a result of its investment in the company. Sergey Brin, co-founder of Google, made a $100,000 contribution to the Prop. 71 campaign in 2004. (For more on that subject, see the last few paragraphs of this item. )

Other investors in iPierian, including John Doerr of Kleiner Perkins Caufield & Byers of Menlo Park, contributed nearly $6 million to the campaign for Prop. 71. The figure was 25 percent of the total contributed to the campaign, which was run by CIRM Chairman Robert Klein. The Kleiner firm also took part in today's new funding round for iPierian.

During the campaign, opponents said that Prop. 71 was little more than seed money for the venture capital community.

CIRM says no connection exists between the contributions and the CIRM award to iPierian. The company and Kleiner have not responded to requests for comments. We are asking again and will carry their remarks verbatim if we receive them.

Ipierian has said it plans to seek CIRM funding in the upcoming $50 million clinical trial round. It is expected to be one of only three companies applying. Today's announcement said the new financing “will allow the company to drive its programs into the clinic, while securing pharmaceutical partnerships.” In March, when CIRM directors approved the concept for the clinical trial round, they were told it would require substantial matching funds from applicants.

The RFA for the round was originally scheduled for April or May but has not yet been posted. On June 7,  we asked Don Gibbons, CIRM's communications chief, why the RFA was delayed. Gibbons has not replied, but one reason for the delay in posting could be that potential applicants needed more time to arrange for matching funds. The RFA is now targeted for posting this month.

Today's announcement from iPierian also said that John Walker was leaving as CEO, a job he has held since February 2009. He is being replaced by Michael Venuti, who was president and chief scientific officer. Venuti praised Walker for his leadership, including securing grants from CIRM.

CIRM Improving Web Site, Easier to Navigate, Better Organized

The California stem cell agency has made some improvements in its Web site aimed at making it easier to use and more helpful to the public.

One good change deals with the way it presents the information concerning the meetings of the agency, improving the organization and making it more intuitive. The new presentation should be more useful to the public and also save time for CIRM. You can find upcoming meetings, transcripts and agendas, complete with background material on the meetings pages.

Other changes involve the disease and governing board pages. The disease pages help people interested in stem cell research and particular diseases. Amy Adams, CIRM's communications manager,  said they now “include resource links, info about grants we've funded in those disease, and links to videos and outside resources. I think these pages are an excellent resource for the community. We'll be adding to these over time.”

The governing board pages provide a better entry point for finding information on the 29 directors of the $3 billion enterprise.

The CIRM has also tried to make it easier for folks around the globe looking for stem cell information. They are optimizing the site to make it easier for “strangers” to CIRM to find the location through Google, Bing, Yahoo and other search engines.

Adams says more changes are in the works. One that we would like to see is a major improvement in the internal search engine – the one that is used to come up with facts and figures actually on the site.

The CIRM Web site has a huge amount of information on it. More is to come. Good organization and navigation tools make it even more useful to the public and CIRM's special constituencies.

Watered-Down Reform Bill Moving Ahead; CIRM Looking at Boosting Staff to as High as 60

The California stem cell agency almost certainly will be able to hire a small platoon of additional employees next year as state lawmakers appear ready to remove a voter-imposed staffing cap.

That, however, may sound more troubling than the reality. The agency still has a 6 percent limit on operational spending, which makes the cap of 50 employees both redundant and a bit foolish. CIRM has labored for some time with what amounts to a staff the size of a 24/7 Burger King, and CIRM President Alan Trounson has warned that the quality of work could suffer.

The agency, with only 45 employees, is trying to oversee more than $1 billion in awards to more than 300 researchers and institutions. At the same time, it is attempting to award another $2 billion in increasingly complex grant rounds that reach into clinical trials and involvement with corporate biotech.

Earlier this year, CIRM said it might hire as many as 15 additional employees. Beyond that, it would run into space problems in its existing offices. Hiring additional employees would also “shorten the life span” of the cash available under the 6 per cent limit, which refers to the $3 billion in bond funding.

The bill removing the cap is headed for placement on what is known as the consent calendar. Items in that category are supposed to be noncontroversial (but there are exceptions) and are voted on as a block with no discussion.

The legislation, SB 1064 by Sen. Elaine Kontominas Alquist, D-San Jose, is currently in the Assembly Appropriations Committee after winning approval in the Health Committee, 19-0, on June 30. After passage by the full Assembly, it will return to the Senate for concurrence in Assembly amendments before it goes to the governor. It would take effect at the beginning of 2011.

Given CIRM's support, the first time ever for such legislation, the bill seems certain to be approved. However, approval requires a rare, super, super-majority vote – 70 percent – of both houses, so it only takes a few legislatiors to bring the bill to a halt.

The stem cell agency backed the bill in a compromise that significantly watered down the legislation. Gone are many reforms recommended by the Little Hoover Commission, the state's good government agency, along with provisions sought by the state's top fiscal officer, Controller John Chiang.

They include elimination of a performance audit by a special Prop. 71-created, financial oversight committee chaired by Chiang. Instead CIRM itself would pay ($400,000 plus) for the audit and control its scope. CIRM already has written into the bill a stipulation that the audit does not have to include “a review of scientific performance.”

Excluding a scientific review gives cover for the agency if it wants to isolate problems it does not want examined. Exclusion also avoids outside review of many of CIRM's key assumptions. However, a detailed scientific review may well be beyond the capability of most auditing enterprises, although they could presumably hire a panel of experts.

But perhaps more important is the fact that the agency would pay the audit firm for the work. If CIRM pays the piper, it calls the tune. Just ask Enron, World.com and others. Any audit paid for by CIRM can be fairly criticized for not being objective. It will mean $400,000 or more for the successful bidder. CIRM has already demonstrated it wants its contractors to be cheerleaders. That was a key criteria for selection of the firm that is now evaluating the economic impact of the agency.

Also gone are revisions in the role and election of the chairman, along with other reforms. The previous provisions would have eliminated the conflicting roles of the chairman, who now has executive management responsibilities, and the president. Problems with the dual executive arrangement at CIRM have arisen in the past and are likely to come up again. Also eliminated are provisions that would have given the board more control over selection of its own chairman.