Have Your Say on $5.5 Billion California Stem Cell Measure; Locations, Internet Access to Public Meeting Friday

The public can participate and listen in on the stem cell agency's meeting on Friday dealing with the proposed, $5.5 billion ballot initiative that could lead to changes in the measure. Some of the agency's board members have already expressed reservations. 

The session is scheduled for two hours beginning at 9 a.m. It will be available via the Internet and also at telephonic locations throughout the state. Here is a current list of the locations, including the stem cell agency headquarters in Oakland.  The locations could change. Instructions for Internet access can be found on the agenda. 

• State stem cell agency -- 1999 Harrison Street Suite 1650, Oakland, CA 94612

Other Locations (updated Nov. 14, 2:36 p.m. PST):

• 10901 N. Torrey Pines Road, La Jolla, CA 92037
• 1001 Health Sciences Rd., Irvine, CA 92697
•  291 Campus Drive, Stanford, CA 94305
• 8700 Beverly Blvd 2015, Los Angeles, CA 90048
• 583 Mrak Hall, 1 Shields Ave., Davis CA  95616
• 100 Kimball Way, South SF, 94080
• 12-231 CHS, David Geffen School of Medicine, UCLA
• 4005 N Fresno St., Fresno, CA 93726
• 837 Health Science Road, Irvine, CA 92697
• 769 Evans Hall, University Dr, Berkeley, CA 94720
• 8170 Laguna Blvd., Elk Grove, CA 95758
• Marina Village Conference Center - 1936 Quivira Way, San Diego, CA 92109
• 765 Market St. Apt 31D, San Francisco, CA 94103
• 15775 Gum Tree Lane, Los Gatos, CA 95032
• 10850 Gold Center Drive, Suite 325, Rancho Cordova, CA. 95670
• 600 16th Street, Genentech Hall, S272D, San Francisco, CA  94158

More Than $300 Million to be Awarded: California Schedules 12 Stem Cell Agency Board Meetings This Year

California's $3 billion stem cell agency has scheduled governing board meetings every month this year as it plans to give away more than $300 million.

The board has two types of meetings: telephonic, which are usually routine, ratifying earlier decisions on individual grant applications, and face-to-face meetings, of which there are only four. The face-to-face meetings often involve approval of concepts for new award rounds or significant changes in rules or policies.

Readers interested in the agency should think about taking in one of the four face-to-face sessions. They provide an opportunity to chat informally with board members along with the top staff of the agency.

The telephonic sessions are run out of the agency's Oakland headquarters, another opportunity for face-to-face encounters with some CIRM board members and staff. 

In addition to board meetings, subcommittees meet off and on during the year, sometimes by telephone and face-to-face. But there is no set schedule.

In both types of meetings, they can be listened to via the Internet and also participated in via remote locations at board member sites. All the meetings can be found at this Web site, which provides transcripts of the sessions. Readers can sign up for automatic notifications at that site. 

Here is the rundown.

January 19th, 2017, Telephonic
February 23rd, 2017 Bay Area, face to face
March 23rd, 2017, Telephonic
April 27th, 2017, Telephonic
May 25th, 2017, Telephonic
June 29th, 2017, Bay Area, face to face
July 20, 2017, Telephonic
August, 24th, 2017, Telephonic
September 21st, 2017, Bay Area, face to face
October 26th, 2017, Telephonic
November 30, 2017, Telephonic
December 14th, 2017, Bay Area, face to face

Meeting dates and locations are subject to change

Oversight Panel of California Stem Cell Agency Schedules First Meeting in 21 Months

The only governmental body specifically charged with oversight of the $3 billion California stem cell agency, an enterprise that operates beyond normal state controls, announced yesterday that it would meet in just three days.

The session of the oversight panel comes 21 months after the last meeting of the Citizens Financial and Accountability Oversight Committee(CFOAC). The panel is required by state law to meet annually. Its last meeting in January 2014 saw the agency criticized harshly by one of the members of the oversight panel.

The committee is chaired by the state controller, who currently is Betty Yee. At the time of the last meeting, the controller was John Chiang, who is now state treasurer.

The agenda for this Thursday's meeting contains no items that would seem to be controversial, only a review of a routine audit and a presentation by the agency itself.

In January of 2014, Jim Lott, one of the members of CFAOC, made it clear at some length that he was not pleased with the agency's performance. He said in part:

“What can we say we've done to advance to a cure or to cures? It's fine that we've got all -- we've contributed to all. What can you say that we've actually done? We don't really have any -- I'm going to just say this because it's a bias and I know it's a bias. We don't have any tangible specific and measurable results that I can point to.”

The $3 billion state stem cell agency is exempt from the usual state budgetary controls. It receives its funds directly from bond proceeds without intervention by the governor or the legislature. The agency’s independence was authorized by voters when they created the agency in 2004 through a ballot initiative that altered the state constitution.

Two sites are available for the public to observe and participate. One is in Emeryville in the San Francisco area and the other is in Los Angles. Addresses can be found on the agenda. The public can also listen to an audiocast of the proceedings. Directions are also on the agenda. 

Looking for Clarity at the $3 Billion California Stem Cell Agency

OAKLAND, Ca. -- Scientists and others seeking the short version of the plans for funding of basic and translational research by the $3 billion California stem cell agency should look no further than an 18-page Power Point presentation.

The explanation is available on the agency’s Web site and in some ways is better than the more prolix description offered in three formal memos. While the presentation offers a fast read, seriously interested parties will need to plow through all three documents. (See here, here and here.)

Critical to understand the direction of the agency, however, is another Power Point presentation -- this one by Randy Mills and which is not supported by a memo or other formal document. But some of what Mills lays out in the slides has been brought up at earlier meetings, the voluminous transcripts of which are available on the agency’s Web site, if you can find them.

A search of the agency’s Web site late yesterday using the term “transcript” turned up 879 results. No transcripts of remarks by Mills or of meetings of the agency’s board of directors were found in the first 14 pages of the results.

In his slides today, Mills is covering his thinking on both basic and translational funding and how therapy development should have a continuous and predictable pathway. He likes to talk about it in terms of rail lines, a homely but apt analogy.   

While we are on the subject of Power Point presentations, the agency’s slides have improved greatly since Mills became president of the agency in May 2014.  Nonetheless, Power Point presentations do not necessarily enhance understanding, especially when the presenters do little more than read the notes on the slides. The result is known as “Death by PowerPoint!”

Slides are no replacement for a single, nuanced, written explanation of a proposal, including charts, something more than the agency usually offers in its memos to the board. That said, their memos have also improved and are more comprehensive and straight forward than under the regime of the agency’s former president, Alan Trounson.

Effort to End $500 Million California Stem Cell Research Loan Program Stalls Again

The California stem cell agency has postponed action on a proposal that would have all but eliminated its $500 million loan program, which has been deemed less than worthy.

A subcommittee of the agency’s board had been scheduled to act on the new plan last Thursday. However, the meeting was postponed at the last minute with no public explanation.

In response to a question, Kevin McCormack, senior director for communications, said last week,

“The meeting was postponed so we could work on the proposal some more before bringing it to the subcommittee. The document was removed from the website because it was actually the wrong document. It was an earlier, outdated version of the proposal and didn't reflect many of the changes that were made.” 

However, the plan (dated March 13) remains on the agenda for the full board meeting on this Thursday. Presumably, failure to remove it as well was an oversight. 

(On Monday March 23, the loan item was re-labelled as postponed on the full board meeting agenda. The plan was still available online via the link above as of this writing.)

This is the second postponement on the loan overhaul. The first came in January and also was cancelled late with no public explanation.

Randy Mills, who was named president of the agency about 11 months ago, said in the March 13 memo to the board that the existing loan effort was “overly complex, administratively burdensome, and, as reflected in the number of loans issued, it does not appear to be attractive to industry.”

Only five loans have been made since the program was begun in 2008.  Only two loans are currently active.

The agency has not responded to a March 18 query concerning whether any businesses provided direct input into the loan changes proposed by Mills. 

The existing loan program was the brainchild of Robert Klein, a real estate investment banker who was the agency’s first chairman.

Mills plans to replace the loan program as part of his efforts to speed development of stem cell therapies. No awards have yet been approved under that effort, which began only on Jan. 1. 

A California Stem Cell Mystery is Solved

The California stem cell agency today cleared up one of the mysteries involving next Thursday’s meeting of its governing board and likely action on a training program.

The agency last Saturday posted the agenda for the meeting that included a cryptic description that appeared to involve the abolition of one of its several training program. The agency did not respond to a query last Monday about exactly what was meant by the agenda item, making it nearly impossible for affected parties to respond in an appropriate and timely fashion.

Following the posting yesterday on this blog of an item describing the situation -- "The California Stem Cell Agency and Its Unnecessary Mysteries" -- the agency added a memo early today from CIRM President Randy Mills to the Thursday agenda. The memo explained that what was involved was the CIRM Scholars Program.  

Look for an item on this Web site early Monday on the expected end to the program.

California Stem Cell Speed-Up: $50 Million for New, Rapid-Action Program

The mystery at the $3 billion California stem cell agency has cleared up.

The agency yesterday posted a document that provided some details on just what is to be considered next week by the agency’s board of directors, and it is very big stuff -- $50 million worth.

It involves what the agency’s new president, Randy Mills, calls CIRM 2.0 and is intended to speed considerably the agency’s work on research that is closer to reaching the public. (The agency is commonly referred to as CIRM after its official name. the California Institute for Regenerative Medicine.)

The information on the new effort came only one business day prior to scheduled action on the plan by the directors’ Scientific Subcommittee, which meets Monday. The proposal is expected to win approval at the board’s full meeting next Thursday in Berkeley.

Mills’ plan calls for spending $50 million between now and next July on grant applications that will be received every month, instead of sporadically as in the past.  The objective of the program is to create "a more streamlined process for awarding and administering grants that will include frequent and predictable submission opportunities followed by rapid review, quick funding decisions, streamlined contracting and the prompt initiation of research."

Applicants can ask for as much money as they want. No caps are being set in advance, but the research budgets will be thoroughly analyzed prior to review. Indirect costs will be limited, however, to only 10 percent of the award. That is a major reduction.  Kevin McCormack, a spokesman for CIRM, said last year that a 20 percent cap exists on indirect costs on awards. Grants also provide for “facilities” costs at an additional percentage that can be much higher than the 20 percent.  The rate varies from institution to institution.  

Matching funds will be required by both business and nonprofit applicants in some cases in the three-stage program. Business applicants will have to show that they have six months of “cash on hand” from the date of the application submission. 

Applications will be due on the last business day of each month, presumably beginning Wednesday Dec. 31. The CIRM board would act on the award about 90 days following submission. Work must begin within 45 days of approval of awards by the full board, about 130 days after submission of the application, according to Mills' memo to the CIRM board. 

Mills’ plan also calls for a major change in appeals of negative reviews, saying they would be limited to “demonstrable conflicts of interest” as defined by CIRM’s existing policies. Mills’ memo said the change was being made because of “the open opportunity to apply and amend  rejected applications.”

Mills has said successful applicants will be strongly guided by CIRM. Unsuccessful applicants will be coached by CIRM on how to alter their proposals if the agency feels their plans have strong potential.

Parties interested in commenting on the plan or suggesting changes can send their remarks to the directors by emailing them to mbonneville@cirm.ca.gov. They can also participate in Monday’s 90-minute meeting at teleconference locations in San Francisco, Duarte, Los Angeles, Irvine, La Jolla and Oakland. Addresses can be found on the meeting agenda, but specific room numbers are not given. Those can be obtained by calling CIRM at 415-396-9100 or email to mbonneville@cirm.ca.gov.

The California Stem Cell Report will have more on this and other CIRM 2.0 changes prior to next Thursday’s meeting.

A Public Mystery at the $3 Billion California Stem Cell Agency

The latest proposal by the California stem cell agency for apparent clinical testing of stem cell therapies could be a $2 million effort or $20 million effort. It could be designed to tackle Alzheimer’s or cancer. It could involve commercial firms or just research institutions.

But no one – outside of the agency – really knows. With only two business days before the proposal is scheduled to be considered by the agency’s directors, it remains under wraps as far as the public is concerned. It is a public mystery.

All that the public is allowed to see as of noon today is a cryptic, eight-word description – “concept plan for new clinical phase development program.”  Indeed, it might not even be a clinical testing program. The language is so vague it could be some other sort of clinically related effort.

The agency’s transparency rules require that agendas for meetings be posted 10 days in advance. However, they do not require that anything truly meaningful be supplied on the agenda. Back in the not-so-good, old days at the agency, important material explaining what was to be considered sometimes was not even available until the day of a meeting. Sometimes board members complained about delays in seeing material for meetings. Sometimes meetings were cancelled as a result.

In many ways, CIRM, as is the agency is known, is now exceedingly open and transparent. In other ways much less so. The problem with the clinical item to be considered Monday by the CIRM directors’ Scientific Subcommittee is an example of the latter.

The agency makes much of its attempts to engage and inform the public – not to mention researchers and the stem cell community.  CIRM says it wants input from all the stakeholders. But no comment – good, bad or indifferent – can be made when the only information available is so limited that it is meaningless.

Researchers particularly have something at stake. Poorly conceived concepts result in poor requests for applications which then result in poor proposals from scientists. Without spelling out just what is being considered well in advance, it is impossible for researchers to comment constructively or otherwise in a timely fashion.

CIRM can and should do better. 

Researchers Seek to Overturn Negative Decisions by California Stem Cell Agency

LA JOLLA, Ca. -- Three rejected applicants for millions of dollars from the California stem cell agency have appealed negative reviewer decisions in the agency's business-friendly strategic partner program.

The agency's staff rejected two of the appeals but is sending one back to reviewers.

Names of the applicants and the amounts sought were withheld by the agency. The agency also withheld the contents of the appeal letters, material that was, until recently, was routinely disclosed.

California Stem Cell Agency Budget Up 10.5 Percent

The California stem cell agency this week proposed a $17.9 million operational budget for the coming fiscal year, roughly a 10.5 percent increase over its current spending.

The largest expenditures in the proposed agency budget are for employee compensation, $12.1 million, up about 4 percent from current spending; grant reviews and meetings, $2.5 million, up 47 percent, and external services (outside contracting) $2 million, virtually unchanged.

The budget information on the agency's Web site was posted yesterday, only two business days before it is to be considered by the agency directors' Finance Subcommittee. The posted information did not explain or justify the increases. Nor did it contain a comparison to the agency's actual spending this year.

The year-to-year comparison was calculated by the California Stem Cell Report, based on figures that were presented to directors in the middle of March (see chart below) and those posted yesterday.
(Later information showed that the annual increase is about 9.5 percent, based on fresher figures for estimated spending this year.)

The boost in compensation is most likely tied to a slight increase in the size of the CIRM staff, which now totals 56. The largest component in the jump in the grant reviews and meeting expenses is a $300,000 meeting for the 600 recipients of the agency's grants. CIRM did not stage a grantee meeting during the current fiscal year.

The agency's operational budget does not include grants or awards for research, only the expenses for handing them out and overseeing their execution. The agency is limited by law to a budget of 6 percent of its awards, which will eventually total $3 billion. It has given out $1.7 billion so far.

The latest budget will be taken up on Monday by the Finance Subcommittee, which is chaired by Stephen Juelsgaard, former executive vice president of Genentech. It will be his first session as chairman of the finance panel. Juelsgaard has demonstrated a flinty-eyed approach to financial matters during full meetings of the CIRM governing board.

The new budget will also be the first for CIRM's new president, Randy Mills, who formally begins his job on Wednesday. However, the proposal probably does not likely to reflect any significant input from Mills, who has made his career in business. He may have proposals for changes in it after he officially begins work or perhaps even on Monday.

Sunlight, Stem Cells and Feathers

California stem cell researcher​/blogger Paul Knoepfler is reporting that he has ruffled some elite feathers in the stem cell community.

In a post last week, the UC Davis scientist said that his heavy coverage of the STAP stem cell flap appears to have offended some. He wrote,

“It seems (the) concept of not talking about bad news is well-entrenched in the stem cell field.... I’ve been informed that I’ve ruffled the feathers of a couple elite VIPs of the stem cell world by covering the STAP stem cell story on my blog and doing the stem cell crowdsourcing experiment. 

“Would they really prefer that we all just skip along merrily singing kumbaya? 

“The reality is that the STAP stem cell situation is a serious threat to the stem cell field. As someone who is a big fan of stem cells and advocates actively for stem cell research, I wasn’t going to turn a blind eye.”

Earlier, Knoepfler also defended his blogging on the subject after stem cell scientist George Daley of Harvard expressed “concern” about the use of social media to discuss the subject. I wrote about that situation on March 7, noting the value of social media as a communications tool.

To get another perspective on the subject, I asked Deborah Blum, the Helen Firstbrook Franklin Professor in the School of Journalism and Mass Communication at the University of Wisconsin, Pulitzer Prize winner and author of five books, for her thoughts. She replied,

“I like social media as a tool for transparency, Dave. It gets criticized for being overwrought, or witch-hunting in nature. But I didn't see that in Paul's post. This may explain, though, why he contacted me on Twitter about a post I wrote a while back called "The Trouble With Scientists" that is a defense of bloggers and smart scientist bloggers. Think of Rosie Redfield's blog post on the so-called arsenic-based life report that helped show the flaws. Or the blog Retraction Watch, by Ivan Oransky, who's both an MD and a journalist. The kind of thoughtful online discussion that I think you saw in Paul's piece adds to efforts to make research more open and more accessible. And acknowledging its flaws is just as important in the process as praising its successes. 

“And I do NOT believe a scientist should be punished for writing responsibly about issues in research. I think it's praiseworthy.”

Knoepfler has added this note to his ruffled feathers item,

“It’s important to point out here that I don’t think this STAP situation, even if it gets even worse, can derail the positive momentum of our field overall, but it can slow things down. Also, the stem cell field needs public trust. When I am out there communicating with the public about stem cells and answering their questions, sadly they often spontaneously mention 'scandals' and 'controversy.' Many folks seem to associate these with the stem cell field already.”

Our take: Trying to bury dubious matters and hide questionable activities has led to the downfall of many organizations and individuals. If the stem cell field is to prosper, especially in age of lightning communications, its leaders should be forthright, open and transparent, whether the matter involves replication of research or conflicts of interest. As the late U.S. Supreme Court Justice Louis Brandeis has been famously quoted, 

“Sunlight is said to be the best of disinfectants."

Conflict of Interest Alleged: Cedars-Sinai Scientist Appeals Rejection of $13 Million for Heart Research

The director of the Cedars-Sinai Heart Institute today asked the governing board of the California stem cell agency to approve his application for $13 million for heart research, declaring that the agency's review of the proposal was tainted by a conflict of interest.

Eduardo Marban
Cedars-Sinai photo

In a letter, Eduardo Marban contested the findings of a CIRM staff review of the conflict allegations. He said,

“The initial review was tainted by conflict of interest concerns. The re-review was conducted by staff in a peremptory manner without the usual CIRM due process: no patient advocates were involved, no comparator grants were evaluated, and no formal review reports have been provided. Only a pithy, dismissive summary by CIRM staff has appeared, and that only yesterday.”

Marban's application was the subject of an article on the California Stem Cell Report yesterday, which discussed the lack of transparency in the agency's grant review process, particularly in relationship to conflicts of interest. The application was quietly removed from CIRM board consideration in December and has been placed on the board's agenda for action tomorrow in Burlingame, Ca.

The agency withheld Marban's name, the names of reviewers and the nature of the conflict charges. Marban did not go into specifics concerning the conflict in his letter today. We have emailed him, seeking details.

Marban has previously received $7 million for research from the agency. Capricor, a company he founded, has received $20 million. The company is scheduled to be highlighted in tomorrow's CIRM governing board meeting as one of its success stories.

In his letter, Marban noted his previous research along with the latest proposal and its clinical potential, an increasingly important consideration for the CIRM board. Marban wrote,

“The commercial potential of (the earlier funded product) has been validated by a collaborative/option agreement between Capricor (the company I founded to develop regenerative therapeutics) and Janssen, an arm of the pharmaceutical giant Johnson and Johnson. This represents the first time that 'big pharma' has partnered with a regenerative medicine biotech to develop a product.”

Marban also said,

“The present proposal (DYNAMIC) is ready to go into patients immediately; it is FDA and IRB approved. In fact, we have a list of 30+ patients who are waiting to be screened for enrollment, as soon as funds are available. These patients are ill, with a mortality exceeding that of many cancers. Indeed, several eligible patients have died in the interlude between the last ICOC meeting, when this proposal might have been funded, and the present.

“DYNAMIC would be the first study in the CIRM portfolio to target hard clinical endpoints (mortality and re-hospitalization) in a very high-risk population (that of advanced heart failure). The population to be studied is very different, and much sicker, than in the ALLSTAR trial.”

The $13 Million Matter of DR3-07201: Allegations of Conflict of Interest at the California Stem Cell Agency

In an unusual move last December, the California stem cell agency removed – with no public explanation – an application for $13 million from consideration by its governing board.

That application is now back before the board on Thursday and is almost certain to be rejected.

What is missing, however, are important specifics about the matter. They are cloaked by the agency's rules that conceal most of the CIRM grant review process, including the names of applicants along with the identities of reviewers and their economic and professional interests. Also shrouded are the details of any complaints about conflicts of interest as well as any other appeals.

Nonetheless, since the proposal was listed on the agenda of a public meeting of a state agency, it is known that it involves application DR3-07201. The unidentified applicant, according to a CIRM summary, sought $13 million for research into a treatment for heart failure, a therapy that is labeled by the applicant in all capital letters as “DYNAMIC.”

The agency's scientific reviewers last year recommended rejection of the request for funding. The agency's review summary said,

“The major serious criticism and flaw stems from the fact that the applicant is currently evaluating the same cellular product in a Phase 1/2 trial in a different subgroup of cardiac patients. Since the objectives of the proposed and currently enrolling trials are similar, reviewers agreed that the proposed Phase 1 trial does not add value and should be re-evaluated after completion and analysis of data from the current trial .”

No scientific score was released for the review but it was last on the list of all applications in this particular round. The agency usually lists the applications in order of their scores.

Following the removal of the application from the board agenda, the California Stem Cell Report in December inquired about the reason. Kevin McCormack, senior director of communications, replied via email,

“We received a last-minute appeal based on an alleged conflict of interest.  In order to allow time to review the claim, we deferred action.  We have done this previously, though I don’t have an exact count.”

When the application popped up on the agenda for this week's meeting, we inquired again, seeking more information. That was seven days ago.

The answer came in the form of a posting yesterday on the CIRM Web site of a one-page memo dated March 7 from Gil Sambrano, CIRM's associate director, review. In the note to the CIRM board, Sambrano said a conflict of interest allegation was raised by the applicant on the morning of Dec. 12, 2013, the day on which the application was to be considered. Sambrano said,

“The applicant alleged that the GWG (grant working group) review of the proposed project may have been 'tainted' by the 'perceived lack of objectivity' of one member of the GWG. There was no specific basis to support a financial, professional or personal conflict as defined in the GWG conflict of interest policy.”

Sambrano said the investigation into the complaint determined there was no violation of the agency's conflict of interest rules. He said,

“We found no evidence that the reviewer had any significant influence on the score or the recommendation. The reviewer was not an assigned reviewer and therefore did not contribute a written critique to the panel. Consistent with the recollection of the review chair and CIRM science officers in attendance, the discussion notes suggest that this reviewer did not provide any comment either in favor or against the proposal. The individual score given by the reviewer was very close to the mean score and thus did not contribute to the broad standard deviation.”

Sambrano continued,

“The applicant also submitted a request for reconsideration based on material new information. Although the applicant provided some information that is new, it did not directly address the main concern of reviewers and therefore did not provide adequate grounds for reconsideration. The request was denied.”

Sambrano said the agency took an additional step of seeking the opinion of two new expert reviewers and the chair of the grant review group. He said they did not find the new information “compelling.”

Reviewer Joyce Frey-Vasconcells was barred from participating in the review of the application, according to its CIRM review summary. Other reviewers in the round who could participate in assessing the application included Joy Cavagnaro, Raj Chopra, Derek J. Hei, Hassan Movahhed and Andrew Balber. Their names were listed on review summaries on other applications in the round where they had conflicts of interest, either professional or economic.

The applicant's appeal does not necessarily end with the CIRM staff decision. The applicant can appear before the board in public on Thursday and seek to overturn the action or ask for further investigation. It can also send material to the agency for delivery to all board members. 

As mentioned previously, the name of the applicant was withheld by the stem cell agency. But it could likely be discerned by a knowledgeable stem cell researcher based on information contained in the review summary. If the applicant would like to send both of its appeals to the California Stem Cell Report, we would be glad to carry their full text and any additional commentary that the applicant would like to make. Other applicants have done so in the past. The agency has no prohibition against such an action and actually has a term for it – self-disclosure.

Our take: The stem cell agency's appeal process ill serves the California public, grant applicants and CIRM itself. The $3 billion agency's reliance on secrecy only raises more questions about cronyism and unfairness, some of which have dogged CIRM since its inception. The recent flap over the $40 million genomics round is only the most recent example. Roughly 90 percent of all the cash handed out by CIRM has gone to institutions that are represented on its governing board, which sets the rules for the grant-making process and determines the nature of the grants. The board's conflicts are built in by Prop. 71, the measure that created the agency in 2004. The only genuine way to ameliorate the issue is with more transparency.

California Stem Cell Agency Withholds Key Information in $40 Million Genomics Proposals

The California stem cell agency has declined to disclose publicly a critical criteria – the amount of matching funds offered by each applicant -- in its ambitious $40 million genomics round scheduled to be acted on later today.

A spokesman for the $3 billion state agency yesterday said the figures were not a public record. However, the agency has public revealed such figures in the past.

The matching funds played a major role in the top ranking of a $33 million genomics proposal by a Stanford-led consortium. Lack of matching funds also was deemed a serious problem by the agency's grant reviewers, who operate behind closed doors, in an application led by the Scripps Research Institute.

When asked for the figures, Kevin McCormack, senior director for public communications, said,

 “That is proprietary information, and so it's not available.”

He has not yet responded a follow-up question about the rationale for cloaking such figures in secrecy that goes beyond the simple assertion that they are proprietary. Generally, proprietary information is considered to be trade secrets or involve intellectual property or unique business methods.

Financing is commonly disclosed by businesses and is even required by federal law when a company is publicly traded.  

Wish List on Criteria for New President of $3 Billion California Stem Cell Agency

Directors of the $3 billion California stem cell agency today moved closer to possibly selecting a non-scientist as the new president of the nine-year-old research enterprise.

On a unanimous voice vote with no discussion, they approved criteria that did not make it mandatory that a scientist fill the position being vacated by Alan Trounson, a noted IVF researcher who is returning to Australia.

Instead, the governing board decided that candidates should have “experience with and personal commitment to medical and scientific research including familiarity with stem cell research.”

In terms of academic credentials, the criteria state that the new president have either or both an M.D. or Ph.D. degree or “equivalent industry experience or similar body of knowledge developed in professional roles.”

The criteria that was approved was not available to the public today on the CIRM Web site prior to board action. It had been altered on Tuesday night from an earlier version that was posted on the Web site.

Here is the text of what appear to be the only alterations (all additions) in the new criteria.

• "Comfort working in the public sector, including an awareness of the need to comply with the laws that govern them, such as transparency, conflict of interest, and public accountability laws." 
• "Experience dealing with, and commitment to, diversity and gender equality in the workplace."

It is ironic that the addition of the need for awareness of the need for transparency was added but the document was not available to the public prior to board approval.

CIRM Chairman Jonathan Thomas said yesterday that the agency is on verge of signing a contract with a search firm, Korn Ferry, to help in finding the new president. Directors have been emphatic about the need for speed in finding the new president.

Trounson has agreed to stay on for an unspecified period, but he could leave at any point. If he leaves before a new president is chosen, presumably Ellen Feigal, senior vice president at the agency, would pick up his duties temporarily, as she did earlier this year for three months.

She is also likely to be a candidate for the top spot, and if she is not selected after serving again on an interim basis, she might well decide to look for opportunities elsewhere.

Stem Cell Agency Board Sticks with More Financial Disclosure

The governing board of the $3 billion California stem cell agency today rejected a proposal that would have restricted transparency surrounding the financial interests of its directors and top executives.

On a unanimous voice vote, the board decided it would stick with the more complete disclosure rules that it has operated under since 2005. CIRM staff had offered changes that would have narrowed the amount of economic information that the board members and the executives would have been required to disclose.

The directors' Governance Subcommittee, however, on May 3 rejected the plan. Sherry Lansing, a former Hollywood film studio CEO and chair of the subcommittee, said at the time,

"I personally feel strongly that because of CIRM's unique mission and the agency's incredibly long-standing commitment to transparency, i believe that we should continue to set an example by requiring the broadest disclosure for members of the board and high level staff."

Retention of existing disclosure rules comes at a time when more conflicts may arise. The agency is moving to engage the biotech industry more closely as it pushes to develop stem cell therapies. Already one case of conflict has arisen this year dealing with industry. It involves a "special advisor" to CIRM who was nominated to become director of a firm sharing in a $14.5 million grant. She also was working for the firm. (See here and here.)

The CIRM board also has built-in conflicts of interest, written into the law by Proposition 71, which created the agency. About 92 percent of the $1.3 billion awarded so far has gone to institutions tied to members of the CIRM governing board. Board members are not permitted, however, to vote on or discuss grants to their institutions. But it is fair to say that if California voters had foreseen that nearly all of the grants would have gone to directors' institutions, they would not have approved creation of the stem cell agency.

As the California Stem Cell Report remarked earlier, it is a good move for CIRM to retain more transparency rather than less. As one of the Moss Adams staffers said today – in a different context – during the presentation of the first-ever performance audit of CIRM,

"When people have to fill a void in information, they assume the worst."

Advisory/Correction

Based on incorrect information on the CIRM Web site, the item below states that Stuart Orkin is currently chairman of the CIRM Grants Working Group. However, he told us in an email that he resigned last November and is no longer on the panel. We are querying CIRM concerning the current status of the chairman's position.

Research Standards Meeting Scheduled for Mid-September

Speaking of timely information from CIRM, the agency this week posted its agenda for a major meeting Sept. 17-18 dealing with research standards and rules.

CIRM's Scientific and Medical Accountability Standards Working Group will gather in San Francisco to review matters involving both the federal government (NIH and FDA) along with New York state's plan to pay for human eggs for stem cell research.

Also on tap are California matters, including CIRM's MES regulations.

No background material is yet available via the agenda. But the timely posting of the agenda allows interested parties to make travel plans, gather their own material and cogitate.

CIRM as a Lobbyist: Mission Creep, Industry Ties and Board Conflicts

The California stem cell agency is once again going to consider its position and lobbying efforts on behalf of industry-supported federal legislation dealing with development of generic biotech therapies.

The topic is expected to be placed on the June agenda of the CIRM board because of a question about whether the board's endorsement of the bill on May 12 complied with the state's open government laws.

On the surface, the matter involves what some might consider a relatively minor legal point. But the endorsement also goes to both CIRM's mission -- whether it should be involved in heavy-duty federal lobbying -- and the agency's ties to the biotech industry and possible financial links involving directors.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., raised the issue of legality of the board endorsement with CIRM's outside counsel, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca. Simpson has shared his exchange of emails with Harrison with the California Stem Cell Report.

Simpson wrote Harrison on May 14, arguing that the motion to support the federal bill was "improperly passed" and is therefore void.

Simpson said,

"No notice was given that there would be consideration of supporting a particular bill. In fact the consensus at the previous (board) meeting was to develop principles.

"Based on the earlier meeting and the posted agenda, I decided not to attend one of the public sessions in person where I would have been able to comment. Instead I opted to listen to the meting over the Web. It is quite possible some (board) members not in attendance made the same decision."

Harrison responded on May 19,

"As you know, (the) Bagley-Keene (act) requires that a board's agenda include a 'brief general description of an item' to be transacted at the meeting. (Gov. Code,§ 11125.) Furthermore, Government Code section 11130.3 provides that an action is not void for failure to provide notice so long as the agenda was in 'substantial compliance' with Section 11125. The board's agenda for its May 12, 2009, meeting clearly satisfied the requirements of Bagley-Keene. Indeed, it specifically cited HR 1548, the federal legislation that was the subject of the motion. The agenda requirements of Bagley-Keene were not intended to prevent debate from evolving or to hamstring a board from taking action. In this case, the board's agenda was more than sufficient to put the public on notice that the board would consider federal biosimilar legislation. We therefore disagree with your assessment regarding the propriety of the agenda.

"Nevertheless, in order to provide a further opportunity for board member and public comment and to address any new developments, Chairman (Robert) Klein has directed staff to include an item relating to consideration of federal biosimilar legislation (HR 1427 and HR 1548) on the board's June agenda. The board will therefore be free to consider public comment and additional motions relating to this item."

Simpson said he disagreed with Harrison's analysis but appreciated that the matter would be brought up again.

The move to endorse HR 1548 by Rep. Anna Eshoo, D-Palo Alto, dates back to last month. (You can read more here, here and here.)

Supporters of CIRM's endorsement of her bill have argued that it is necessary to protect the biotech industry, which has perennial financial problems, so that it will develop drugs. Opponents have worried about mission creep at the tiny agency, which has a staff of about 39 persons. They have also suggested that CIRM is fooling itself if it thinks it can be a major player in Washington.

One anonymous reader also raised concerns about possible conflicts of interests among board members. In a comment filed on our May 12 item, the reader said "the whole thing stinks." The reader wrote,

"The industry members of the board include at least one self-described former employee of biotech leader, Genentech. Are there stock options? What about former Chiron founder and ex-vice-chair, (Ed) Penhoet, does he have stock options? What about the new CIRM counsel, formerly at Genentech, does she have
options?

"What about the two UCSF members, the UCSF (medical school) dean and Jeff Sheehy, who now answer to a former Genentech executive, UCSF's new
chancellor?...

"The whole thing stinks. Using a position on a state board to direct state funds to lobby for a bill to advance one's own private interests over those of patients ought to be against the law. This smells like Cheney and Halliburton!"

We do not have answers to the reader's questions, but we should note that Sheehy has expressed major reservations about endorsing the bill. Nonetheless, the reader's concerns highlight the conflict-riddled nature of the stem cell agency and the virulent suspicions that the situation can generate. The reader's comments also speak to CIRM's transparency and accountability, which will come under scrutiny this afternoon in Sacramento.

That's when a subcommittee of the state's Little Hoover Commission, the state's good government agency, will consider possible recommendations for changes in the operation of the $3 billion state stem cell research effort.

CIRM Calendar Hooha Raises Transparency Issues; Agency Says Calendars Cost $23 Each

The California stem cell agency said today that its 2009 calendar cost $23 apiece and provided figures that indicated the total expense for the calendars was about $35,310.

Based on the numbers provided by CIRM, that seems to mean that 1,535 calendars were printed. Earlier, CIRM said the calendars were sent free to its grant recipients and trainees to remind them "365 days a year where their funding comes from." The agency has 448 recipients and trainees, according to figures on its web site. Calendars were also sent to an unspecified number of "constituents."

In comments on our earlier item on CIRM's 2009 calendar, some readers of this blog said production of expensive, free calendars is a waste of taxpayer money.

Here is the current breakdown on the calendar cost, based on a CIRM report and information supplied by Don Gibbons, chief communications officer for the agency: Printing, $14,000; design, $10,200, and $11,110, which was part of a larger contract.

The $11,110 is a new figure and came today from Gibbons. He said it was part of a $45,000 expenditure with Abbott and Company that CIRM now says was for "image development, office art design and framing." The Abbott contract was initially identified as involving the calendar. After the California Stem Cell Report inquired about the calendar project, the description of Abbott contract was altered on the CIRM web site to remove any mention of a calendar. No footnote was provided on the PDF document to notify the public or directors that a change had been made from an earlier version.

Here is the text of what Gibbons sent earlier today concerning our original item on this subject.

"For the record, you never asked me for the cost per calendar. Instead you chose to make one of your usual worst-case projections. The portion of the Abbott contract that covered the calendar was $11,110, which made the cost per calendar $23. Also, this project began in July, long before the complete budget meltdown."

More than a week ago, we asked Gibbons for the total number printed. He has not provided that number. Following his latest email today, we asked again for that information as well as the number distributed and the cost of postage.

As for our "projections," you can read them here along with our assumptions. They were based on information from CIRM, which was incomplete then and remains incomplete today.

The CIRM calendar is a minor expense in the agency's $13 million operational budget. But outside contracts are not. They now total more than $3 million, up from $2.7 million, as the result of action earlier this week. The outsourcing, which often poses major oversight issues for government agencies, is the second largest category in the budget.

How the agency describes the contracts and other budget items and responds to questions about them is basic to the agency's transparency and openness. The calendar issue is not the only one. A lobbying contract with the Nielsen, Merksamer firm in Sacramento continues to be described as "public education." There may be other fanciful descriptions, but without an examination of contracts and other documents, it is impossible to tell.

Several years ago, CIRM directors initiated the requirement for regular reports on outside contracting because they felt they were not fully informed. While creative budgeting occurs in every organization, without good information it is impossible to make good decisions.

Obviously it is nice to offer gestures of good will to "constituents" and others associated with any enterprise, but CIRM's calendar project came at an impropitious time. The project began shortly after a salary freeze at the CIRM that ran through December. As we remarked then, such freezes affect those on the lower end of the pay scale much more harshly than at the top levels. Perhaps during the holidays, CIRM management could have spread that $35,310 among employees making less than $70,000 a year. That would have been a nice gesture as well.