Murky Backdrop on $5.4 Million Grant to Burnham Scientist

Directors of the California stem cell agency tomorrow will be asked to approve a $1.85 million increase in a grant to a Southern California researcher after he filed a proposal that violated CIRM's rules against spending CIRM funds out of state.

The CIRM staff made the recommendation for the 50 percent boost (for a total of $5.4 million) in the grant to Evan Snyder of the Sanford-Burnham Medical Research Institute in La Jolla. Last April CIRM directors approved a $3.6 million award to Snyder, apparently without knowing that it would violate the explicit ban on non-California spending. The staff said the money was needed because of the increased cost of moving the work to California.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., called on directors to reject the grant outright. To do otherwise, he said, would be “extremely unfair to other applicants who followed correct procedures.”

In a statement to the California Stem Cell Report, Simpson said (full text available here),

“Either the applicant deliberately flouted the rules requiring all research to be done in California and thought he could get away with it or he didn't understand the rules. In either case he did not follow them.

“Assume the best and, unlikely as it seems, grant that a top California researcher and his institution didn't understand CIRM's regulations. But just as ignorance of the law is no excuse, ignorance of the rules governing CIRM awards is no an excuse for not following them.”

In response to a query, Snyder defended his proposal. He said the proposal uses California taxpayer funds "in the most economical and frugal manner possible.” He said Simpson “is misinformed about the most parsimonious way of stretching California biomedical research dollars during hard financial times. CIRM and the ICOC(CIRM directors), in fact, exerted exceptional fiduciary (not to mention scientific) responsibility in awarding this grant. They awarded the contract to the lowest bidder.”

Just how all this came about is a bit murky. CIRM shrouds its grant-making process in secrecy. Names of grant applicants are not revealed until after the winners are approved. Names of rejected applicants are never disclosed. Even today the CIRM staff information on the Snyder grant that is being presented to directors tomorrow does not include his name or the name of his employer. However, that information was given to directors last April as part of its “extraordinary petition” process. The staff report itself became public on the CIRM Web site only three business days prior to the CIRM board meeting in Sacramento.

Asked for a comment, Don Gibbons, chief communications officer for CIRM, said “The budget for the California researcher included a research subcontract to a U.S. organization outside California. CIRM followed standard practice for this funding round, performing a detailed budget review of each proposal approved by the board. When it became clear that this proposal included a subcontract that CIRM could not fund, CIRM asked the PI if the proposal could be revised to meet CIRM funding requirements.”

Gibbons did not respond directly to a question about how an application proposing out-of-state spending came to be approved by the board. (More of Gibbons' response can be found here.)

Gibbons also did not respond to a request for the identity of the non-California recipient originally proposed by Snyder. But in Snyder's response (full text here) to the California Stem Cell Report, Snyder refers to the St. Kitts Biomedical Research Foundation in the Carribean. Snyder said it is “the best non-human primate facility for Parkinson's Disease research in the world.” However, it is unclear whether that was out-of-state spending identified by CIRM.

The Snyder grant poses some important questions for CIRM directors.

Should they reward a researcher who failed to follow CIRM rules?

Would that be fair to other applicants?

Should CIRM President Alan Trounson have been involved in the review of the proposal, which has collaborators at Monash University in Australia, an institution where Trounson presided over the stem cell research program? Presumably a failure to fund Snyder would have a negative impact on his Australian counterparts(Trounson's former colleagues), although they are not funded by CIRM.

How does the situation affect the public perception of CIRM? Snyder's boss, John Reed, the president of the Sanford-Burnham Institute, sits on the CIRM board although he cannot vote on the grant or even take part in the discussion about it. Should Trounson take part in tomorrow's discussion of the Snyder grant?

Would the situation have been handled in the same fashion if the grant applicant had been from a less illustrious institution, such as UC Merced?

Is the research so compelling and urgent that it overwhelms any sort of negative reaction? Or would it be better to defer the issue until additional information is available to directors and the public?

These questions should be considered in the context of a recent chorus of recommendations for more transparency and accountability on the part of CIRM. (See here, here, here and here.)

Text of Simpson Comment on Snyder Grant

Here is the text of the statement from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., concerning the Evan Snyder grant.

“Either the applicant deliberately flouted the rules requiring all research
to be done in California and thought he could get away with it or he didn't
understand the rules. In either case he did not follow them.

“Assume the best and, unlikely as it seems, grant that a top California
researcher and his institution didn't understand CIRM's regulations. But
just as ignorance of the law is no excuse, ignorance of the rules governing
CIRM awards is no an excuse for not following them.

“Granting this award would be extremely unfair to other applicants who
followed correct procedures. The ICOC should reject this grant. If he can
figure out how to follow the rules, then the researcher can apply the next
time a similar RFA is issued.”

Text of Snyder Comment on his CIRM Grant

Here is the text of Evan Snyder's response to a request for comments involving his CIRM grant.

“Actually, contrary to Mr. Simpson's assertions, this project uses the funds of California's taxpayer's -- particularly those who suffer from Parkinson's Disease and other neurodegenerative diseases -- in the most economical and frugal manner possible. The only authentic model of Parkinson's Disease that is predictive of how patients will respond to therapy -- both in terms of benefits and side-effects -- is the non-human primate model. The best non-human primate facility for Parkinson's Disease research in the world is the Axion/St. Kitts Biomedical Research Center. This facility, which has been studying Parkinson's Disease for ~30 years, was, in fact, chosen as the Michael J. Fox primate facility for precisely this reason. Not only is this facility the best in the world, but also the most inexpensive. No primate facility in California was able to match its cost, match its expertise and scientific rigor, or match its facilities. UC-Davis, the only competitive primate facility in California, is not capable of maintaining this model of Parkinson’s Disease, particularly the enormous amount of care of vigilance required. Indeed, UC-Davis does not even house the African Green Monkey which is required; rhesus monkeys are known not to offer the same predictive value. (As might be recalled, the first clinical trials using fetal tissue in PD failed to an extent because representative preclinical animal models were not used, a problem eliminated in this proposal.) It would take a number of years for UC-Davis to bring their facility up to the level of excellence required by these studies (which could lead directly to clinical trials). Furthermore, they would need to charge 300% the cost being devoted to the animal studies now; in other words, for the same amount of work, this project would need a budget nearly 3 times its present budget with a delay in its work by years. The African Green monkey furthermore requires a near tropical climate with indigenous tropical fruit and housing in an open free-ranging, colony setting. That climate or housing demands cannot be created in California.
“There is a long experience in California – including via CIRM – for obtaining animal models from the facility that produces the models the best. For example, mutant mice and other specialized murine models are obtained from Jackson labs -- even though it is in Maine -- because that facility produces the animals required. (I should mention that Axion/St. Kitts Biomedical did have a California office in its early days and will be renewing that). The only CIRM-funded work being done out of California on this project are those tasks that require a living animal -- i.e., transplantation, behavioral assessment, and possibly imaging. Once a living behaving animal is not required, all study materials are transported back to California for the real scientific analysis. This is done only by California scientists and staff. Dr. Redmond, the only key personnel member on the team not presently a permanent California resident, manages the facility and performs the surgeries and, hence, must be on site; nevertheless he is in the process of becoming a formal Sanford-Burnham adjunct professor (he has served in that role informally for a number of years). Furthermore, for one week each quarter, Dr. Redmond will live in California working with the team to further analyze the data -- the real purpose of the proposal.

“Hence, Mr. Simpson is egregiously mistaken about the nature of the grant and, most importantly, about the nature and requirements of Parkinson's Disease research that has any chance of aiding California patients. Furthermore, he is misinformed about the most parsimonious way of stretching California biomedical research dollars during hard financial times. CIRM and the ICOC, in fact, exerted exceptional fiduciary (not to mention scientific) responsibility in awarding this grant. They awarded the contract to the lowest bidder. And California is not only getting the fruits of arguably the best Parkinson's Disease research team in the world using the best Parkinson's Disease model that exists, with the shortest trajectory to treatments, but is getting it at the lowest price available in the world. Given these facts, one is lead to question Mr. Simpson’s true concern for the disease sufferers in the state as well as his concern for the most parsimonious use of taxpayer money.”

CIRM on Snyder Grant

Here is additional information from Don Gibbons, chief communications officer from CIRM, on the Evan Snyder grant.

“The budget for the California researcher included a research subcontract to
a US organization outside California.  CIRM followed standard practice for
this funding round, performing a detailed budget review of each proposal
approved by the Board.  When it became clear that this proposal included a
subcontract that CIRM could not fund, CIRM asked the PI if the proposal
could be revised to meet CIRM funding requirements.  The PI proposed an
alternative that would move that work into California. Dr. Trounson and the
science office, with additional input from an expert in Parkinson¹s
Disease, concluded that the alternative approach would be a scientifically
acceptable alternative that would meet the objectives of the original proposal.

“Because the alternative approach has an increased cost, ICOC approval is
needed for the project to proceed. “

Correction and More Details on Snyder Grant

The California stem cell agency says the out-of-state work planned by Evan Snyder of the Sanford/Burnham Institute in his $3.6 million grant was scheduled for another party elsewhere in the United States – not Australia.

We reported incorrectly yesterday that the matter involved work in Victoria. CIRM posted documents about the matter for its board of directors meeting tomorrow, but did not name Snyder or the other collaborator. The only collaborators we could find in publicly available documents were located in Australia.

CIRM explicitly bans the use of its funds for work out of state. Applications for grants carry a clear notice to that effect.

Directors are now being asked to increase Snyder's grant to $5.4 million to pay for the increased costs of moving the work to California. The grant was originally approved by directors last April.

Bad Link Fixed

A bad link to the "extraordinary petition" mentioned in the item below has been fixed.

$50 Million Clinical Trial Effort Proposed to CIRM Directors

The California stem cell agency has released additional information on its proposed, first-ever funding round for participation in clinical trials.

The plan, expected to be approved on Thursday by directors, would provide $50 million for one or two trials and would be limited to “novel cell therapies from pluripotent stem cells.” Both businesses and non-profit institutions could compete, but businesses would be required to take a loan instead of a grant. In both cases, matching funds would be required. No match percentage was specified.

The goal, a CIRM document said, is

“completion of early stage clinical trials within three years that: 1) demonstrate preliminary safety in humans and 2) provide compelling data for proof of mechanistic concept and/or early testing for efficacy that could lead to more definitive efficacy studies.”

The clinical trial proposal is part of CIRM's aggressive push to develop therapies from stem cells. The agency has already committed one-third of its $3 billion in resources. It will need to show some high profile, tangible results if it is secure additional funding in a few years.

California voters approved the stem cell research effort five years ago, creating CIRM as a way to circumvent federal restrictions on funding for human embryonic stem cell research. Prop. 71 gave top priority to support for that area. Notably, however, the clinical trial proposal does not extend to hESC research.

The plan is part of a relatively brief agenda for the CIRM board meeting in Sacramento this week. Traditionally, board members use part of the day to discuss CIRM privately with legislators and legislative staff.

Another matter on the agenda involves a grant in which a La Jolla researcher planned to use state funds to finance research outside of California, which is barred by CIRM. The $3.6 million grant to Evan Snyder of the Burnham Institute was approved by directors last April. Apparently it was unknown at the time that Snyder planned to use state funds outside of California. After months of discussions and the hiring of an outside consultant, CIRM staff is now recommending that the grant be funded at $5.4 million to handle the increased costs of doing all the work in California.

The staff report said,

“CIRM staff was assured that the core facilities at the grantee institution were adequate and could replace all the research activities critical to this project. To address the ability of junior staff to substitute for experienced senior out-of state investigators, CIRM was reassured that, in addition to the expertise of the PI, there is an established collaborative, integrated multi-institutional network that will be actively engaged in the project and can provide scientific and technical expertise to complement the newly hired and more junior staff. CIRM also received adequate assurances with regard to the ability of the PI to commit adequate time to the project.”

Not discussed in the staff report is the question of exactly how the grant happened to win approval from CIRM directors with the non-California component. CIRM rules are explicit on the ban on the use of CIRM funds outside of California. We are querying the agency concerning the matter.

Oddly, the staff report also does not mention the names of those involved and the institutions despite the fact that they were identified to the board last April.

The grant was approved by directors after Snyder filed an “extraordinary petition,” which is usually an appeal by an applicant who has been rejected by scientific reviewers.. In Snyder's case, reviewers, however, had approved it for funding.

Also on the CIRM directors' agenda is a proposal that would apparently increase the salary for the new vice president of research and development, who would effectively be the No. 2 staff person at CIRM. Currently the top of the range is $332,000 but does not seem high enough to lure the right person. CIRM has not provided any details, however, other than a terse listing that compensation for the position will be considered by directors.

Another item to be considered involves recommendations on new state legislation affecting CIRM. As we reported earlier, the agency hopes to sidetrack the bills by asking that they be sent off to interim study for a year or so.

The latest version of the agenda contains instructions for listening to the board proceedings via the Internet.

(Editor's note: An earlier version of this item incorrectly said that the Snyder grant would have used CIRM funds to support his Australian collaborators. CIRM said that funding in that country is coming from a non-CIRM source.)

Howlers: Loud as Thunder

From time to time, we have discussed the media and its behavior in connection with the California stem cell agency.

The other day, we ran across an apt, media-related commentary in Barbara Kingsolver's new novel, “The Lacuna.”

The remark was offered by one of her characters during a discussion of newspapers with Leon Trotsky in Mexico prior to World War II. One could say that it still applies more than 70 years later.

Here is how it went:

“It's true sir. The newspapers are like howlers on Isla Pixol.”

“What are these howlers?” Trotsky asked.

“A kind of monkey, very terrifying. They howl every morning: First one starts, then a neighbor hears it and starts his own howl, as if he can't help it. Soon the whole forest is bellowing, loud as thunder. It's their nature, probably they have do it, to hold their place in the forest. To tell the others no one has gotten the best of them.”

Communications Subcommittee Meeting Delayed

The California stem cell agency yesterday postponed the first meeting of the directors new subcommittee aimed at improving communications with the public.

CIRM Chairman Robert Klein cancelled the session for personal reasons, the agency said. The session has not yet been rescheduled.

CIRM Director Prieto's Comments

We would like to call attention to comments filed by Francisco Prieto, a member of the CIRM board of directors and a Sacramento physician, concerning our “School Children vs. Stem Cell Scientists” item. His thoughtful remarks offer extra insight into the stem cell agency. Prieto's comments can read by clicking on them at the left or at the end of the item in question.

CIRM Moves Adroitly in Attempt to Sidetrack Legislation

The California stem cell agency is taking a different tack concerning unwanted legislation that would alter the way it does business.

In the past, CIRM directors have opposed all legislation that would affect it. While measures have passed both houses with more than 70 percent votes, the governor vetoed them at the behest of the agency.

However, last week the directors' Legislative Subcommittee decided to ask that legislation by state Sen. Elaine Kontominas Alquist, D-San Jose, be sent to interim study. The move is politically adept. It serves the same purpose as outright opposition. If the agency is successful in sending the bill to interim study, it effectively kills the bill for the next year or so but CIRM does not appear to be stone-walling legislative and other critics. The move instead would put CIRM in the public position of appearing to be listening carefully to those who are raising questions.

The agency's new tactics came to light in response to a question last week that we posed to Don Gibbons, chief communications officer for CIRM, concerning what action the subcommittee had taken.

He said the directors subcommittee acknowledged CIRM is “not perfect.”

Gibbons said,

“Moving the bill to interim study not only involves allowing CIRM to educate the legislature on our progress but also allows the committee chair to call a hearing after the legislature adjourns to provide substantive oversight to review the progress that CIRM has made on all the issues raised by the Little Hoover Commission and the Controller’s Financial Accountability Committee and verify the transparency we all support.”

Alquist's bill, SB1064, is aimed at ensuring affordable access to therapies financed with taxpayer funds and providing for more accountability and openness from CIRM.

Gibbons also said the directors subcommittee voted to seek further study of an umbilical cord blood banking bill that would provide birth certificate fees to CIRM for that purpose.

The full text of Gibbons' statement can be found in the item below.

Text of CIRM Comments on Alquist Legislation

We asked Don Gibbons, chief communications officer for CIRM, last week about action by the CIRM directors' Legislative Subcommittee on legislation concerning the agency. Here is the full text of his response.

“The Legislative Subcommittee expressed concerns about SB1064, introduced by Sen. Elaine Kontominas Alquist of San Jose. The bill would alter the management structure of CIRM in ways the subcommittee suggested the Senator and her staff did not fully understand. Acknowledging that CIRM is not perfect the committee did not recommend embracing or rejecting the bill, but rather to seek a vote in the legislature to move the bill to 'interim study' to give CIRM staff time to educate members of the legislature and their staffs about the related issues.

“Moving the bill to interim study not only involves allowing CIRM to educate the legislature on our progress but also allows the committee chair to call a hearing after the legislature adjourns to provide substantive oversight to review the progress that CIRM has made on all the issues raised by the Little Hoover Commission and the Controller’s Financial Accountability Committee and verify the transparency we all support. In short, we are welcoming legislative oversight and looking forward to the outside scientific review that President Trounson has been putting together for later this year.

“The subcommittee also voted to seek further study of the impact of  AB52, introduced by Assemblyman Anthony Portantino of Pasadena. That bill would move from the Department of Public Health to CIRM the previously legislated authority to receive fee surcharges from birth certificates to fund the  collection and oversight of public banking of umbilical cord blood in California. This study would be internal with the CIRM Science Office directed to look at issues around the science, logistics, and liabilities of such a service with the help of appropriate outside experts.”

School Children vs. Stem Cell Scientists; A Public Perception Problem

From Humboldt to San Diego, thousands of Californians yesterday protested the budget cuts that are ravaging efforts to teach their children to read, write and calculate.

The picture painted in newspapers and on television stands in dramatic contrast to the situation at the financially comfortable California stem cell agency. Its finances are uniquely isolated from both normal state budgetary controls and the state's budget crisis. Consequently next week, CIRM is expected to move forward on a project involving tens, perhaps hundreds of millions of dollars. No details are available, but it is an effort to aid the biotech industry with the costly clinical trials that are necessary to bring products to market. CIRM directors are also expected to put more money on the table to hire an executive to fill a newly created position that is designed to tie the $3 billion program ever closer to industry. A salary of $332,000 a year, currently top of the current range for the job, is apparently not enough of a lure.

Good arguments exist for these actions. They may in fact be good policy for the stem cell research program. But they do not reflect the travails of the rest of California state and local government. The Golden State is now scraping the bottom nationally in terms of per capita spending for the education of its children -- who certainly represent the future as much as the 300-plus stem cell scientists and institutions that have received $1 billion from CIRM over the last five years. Indeed, California's financial problems are so severe that some say the state is effectively, if not legally bankrupt. One of the causes is ballot-box budgeting, voter approval of spending initiatives that that cannot be controlled by state lawmakers or the governor. Such is the case with CIRM's finances.

Unpleasant comparisons pose a public perception problem for CIRM. Fortunately for the agency, however, it operates in a media shadow. CIRM is all but invisible in the mainstream press. Reporters are focusing on broader issues and higher profile matters, such as the release of prisoners from jails because of a lack of money. The fact is that CIRM's finances have virtually no current impact on the state's financial crisis. Nonetheless, CIRM's spending carries symbolic importance, which CIRM directors should be cognizant of as they vote to spend millions more that the state must borrow. Their largess could bite back as lawmakers wrestle with legislation to ensure more openness and accountability at CIRM.

Next Thursday's meeting of the CIRM board of directors will, in fact, be in the bowels of the beast, so to speak. The 29-directors are scheduled to convene in a large meeting room in the State Capitol. Their agenda is relatively brief. Traditionally, following the meeting, directors fan out to meet with lawmakers privately.

As far as meaningful public participation is concerned, CIRM discourages that by withholding justification and details on what is to be discussed by directors. That includes the proposal to take part in expensive clinical trials, which was deferred from the February meeting. Also not available is size of the proposed salary for CIRM's new vice president for research and development, who will effectively become the No. 2 executive on CIRM staff. CIRM already enjoys some of the highest salaries in state government. President Alan Trounson earns $490,008 a year and was once listed as the second highest paid state employee outside of the UC system.

The lack of information on the specifics of what CIRM directors are considering is pretty much standard practice for the agency, despite calls for more openness and transparency. The reasons are unclear for CIRM's failure to post information in a timely fashion prior to directors' meetings, which are not even noticed on CIRM's home page on the Internet. The sessions, however, are the most important activities at the agency. That's when the direction of research is set, standards established and money handed out. We may see additional information posted next week, but usually it comes too late for the public or interested parties to make plans to attend the meetings or formulate a considered comment.

On Monday, a new subcommitte of CIRM directors will discuss ways to improve communications and sell its story to the California people. One good first step would to be mandate that background information for meetings be posted at least five business days prior to the sessions. A modest but do-able goal.

Telling the California Stem Cell Story: $1 Million for PR/Communications and More Likely

The California stem cell agency is already spending more than $1 million on selling itself, but its directors could be asked next week to bump up that figure substantially.

The subject will come up Tuesday at the first meeting of the directors' new subcommittee on communications, chaired by Robert Klein, a Palo Alto real estate investment banker who is also chairman of CIRM. Topic one on his agenda is “potential strategic options for communicating with the California public regarding CIRM’s performance.”

With the meeting only four business days away, no specific information is yet available for the public on just what Klein is proposing, which is ironic for a panel that is being called on to improve communications. The session also follows recommendations in January from a sister state panel to CIRM that called for more openness and transparency on the part of the $3 billion enterprise.

The new communications panel was created in December with little debate by directors, who were told that outside experts would assist in the new communications drive.

Missing from next week's agenda is the question of just what CIRM hopes to achieve with its communications/public relations program.

Does it want to change or shape public opinion in California? In the nation? If so, in what way? How can that be measured? The last question is the trickiest for public relations programs, whose goals tend to be squishy. Public relations practitioners often focus on activities as opposed to results.

One implicit, if not explicit goal of the upcoming public relations push is likely to be creation of an environment that would make the legislature eager to provide billions more for CIRM. Another potential goal would be to set the stage for voter approval of another huge bond measure. Without a major public relations push, winning more cash could be difficult given the deep financial problems facing California state government – not to mention a host of other worthy causes seeking state funds, ranging from the state's beleaguered education system to poor persons who need medical care.

Underlying the discussion is the question of the role of public relations at a state agency. Should CIRM be engaged in a taxpayer-financed campaign to perpetuate itself?

All state agencies have a responsibility to communicate effectively with the public. Naturally they peddle a point of view that supports what the agency does. But when do California public servants cross the line between straight-forward communication and aggressive, full-blown marketing/PR campaigns that are commonly found in business and politics.

Beefing up CIRM's PR efforts will not come cheap. The agency is spending about $1.1 million already, according to figures compiled by the California Stem Cell Report. The total includes $616,772 in outside contracts and roughly $500,000 for salaries and benefits for three staff persons, including the $190,008 salary for communications chief Don Gibbons. The figure for outside contracts includes some two-year contracts, including one for $230,000 with Fleishman-Hillard, Inc.

Our total does not include the $200,000 for CIRM sponsorship of the annual convention of the International Society for Stem Cell Research in San Francisco this summer, which could be called a maketing/PR expenditure.

At the Feb. 3, 2010, CIRM directors meeting, both Klein and co-vice chairman Art Torres raised questions about the Fleishman contract. Torres said that the directors communications subcommittee should review it to determine exactly what the firm is doing. Klein also was critical of the news and information clips that are being provided by Fleishman via Gibbons. He circulates the news clips to directors and another version of the clips to CIRM's more than 300 grantees.

Klein's and Torres' comments came during a briefing by Gibbons on the agency's communications effort. He said he and his staff are “reaching for the heart and the brain of the consumer.”

Because “so little” is left of the traditional media, Gibbons said that “bypassing” it is “very important to us.” He said the “gold standard” is face to face communication. He told directors he was preparing computer slides for them to use to speak to groups about CIRM. Another “very, very warm and fuzzy” presentation is also in the works to be used by patient advocacy groups, Gibbons said.

Gibbons cited a report sent to directors at the beginning of the year. It said that from December 2007 to December 2009, CIRM was “mentioned” in 1,233 articles in “various media.” Six favorable opinion pieces or editorials appeared in California newspapers. No negative coverage was reported, although some occurred.

Directors were also briefed on CIRM's online and social media efforts, including its own much improved Web site and presences on Facebook, Flickr and YouTube. The CIRM Web site receives about 11,000 “unique visitors” a month. According to Wikipedia, the term “unique visitor” is “a statistic describing a unit of traffic to a Web site, counting each visitor only once in the time frame of the report.”

About 55 percent of the audience comes from California, including many from CIRM itself and grantee institutions or recipients. Ninety persons, including a “large number” of disease advocacy groups, have signed up for CIRM's electronic monthly digest.

CIRM is making efforts to drive more traffic to its online sites, but that is one of the more difficult chores facing folks in cyberspace. CIRM's numbers are low compared to major news sites, which run into the millions, but its subject is specialized. Few persons wake up in the morning with a compelling need to check out the latest on CIRM's doings.

A high profile breakthrough in research would generate more online traffic as would a scandal. Major stories in the mainstream media also generate significant, new traffic on Web sites. Despite their declining numbers, newspapers remain the backbone of the news business in this country. A front page piece in the Los Angeles Times, which has all but ignored the stem cell agency, could dramatically push up CIRM's numbers at least temporarily.

The fundamental communications challenge for CIRM may well be time, as it is for all media. People only have so much time in their days. What they read and what they do on their computers is linked to what they consider important to their lives and what is high in the public eye. In other words, what people talk about.

In 2004, then President Bush was an unconscious ally of the folks who wanted to create CIRM via a ballot initiative. Without Bush's opposition, hESC research would have remained tucked away in the public consciousness. Bush's stem cell orders instead triggered a tumultuous national debate that raised the visibility of stem cell science and set the stage for voter approval of Prop. 71.

Today, the federal government is funding hESC science. President Obama has rescinded Bush's ban. The grand debate has slipped away, although the adamant foes continue to work their constituencies. Without a strong catalyst, CIRM is likely to have a difficult time raising its profile and building a public relations position that would justify billions of dollars more for stem cell research in California.

The public can take part in Communications Subcommittee meeting at teleconference locations in San Francisco, Irvine, Los Angeles(3), Menlo Park and Emeryville. Addresses can be found on the agenda.

(Editor's note: Gibbons communications presentation begins on p. 121 of the transcript of the Feb. 3, 2010, board of directors meeting. The slides that went with the presentation can be found here(slides 38 through 66). The December report on communications can be found here.)

Analysis of CIRM Challenges on HealthyCal

HealthyCal, a Web site dealing with health issues facing California, has published an analytical overview of the California stem cell agency written by the publisher of this Web site.

It begins:

“A little more than five years ago, visions of seemingly magical stem cell cures danced in the minds of California voters. Lured by the promise of human embryonic stem cells and the intransigence of the Bush administration, Californians voted to borrow $3 billion and give it away to scientists to come up with therapies for ailments ranging from Alzheimer’s to diabetes.

“In approving Prop. 71, voters repudiated the Bush administration ban on funding of human embryonic stem cell research. The voter initiative also created the California Institute for Regenerative Medicine (CIRM), an enterprise unlike any in state history and one that is uniquely independent of the governor and the legislature. It is also an agency that is facing a new set of challenges as it enters its second five years of existence.”

You can read it all here.

The Hidden Cost of Long Hours

The chairman of the California stem cell agency, Robert Klein, likes to point out that the tiny staff at the $3 billion enterprise works long hours to deliver the goods for its directors and the hundreds of researchers and others who enjoy the state largess.

In December, CIRM President Alan Trounson provided a few specifics. He told CIRM directors that some CIRM employees were at work until 11 p.m. He added,

"This morning, it was two in the morning, they were still responding to e-mails from me, so you have to say there's something very special about this group of people."

What Klein and top CIRM management do not mention is the hidden cost of the midnight oil.

What this kind of pace means is that people put off taking legitimate vacations and rack up uncompensated time off, which must be paid for at some point. According to its own annual audit, CIRM owes $370,067 to its employees for “unused compensated leave.” That includes vacations that have not been taken, “annual leave” and compensatory time off for those long hours. Already the agency has paid out $203,022 between 2006 and 2008 to 22 departing employees, according to state figures compiled by California Watch.

(The non-profit newsgathering organization put together the figures for a story by Chase Davis that was carried in some California newspapers today. He reported the state has paid out an estimated $100 million to departing state employees over about 3.5 years, ignoring rules that bar the workers from amassing such huge benefits.)

The CIRM staff, which now numbers in the mid-40s, indeed deserves considerable praise for its diligence. But the reasons for the long hours and resultant stressed staff – not to mention costs down the road – are not so deserving of praise. One can begin with Prop. 71, which is a 10,000-word tribute to micro-management, and immutable micro-management at that. Written by Klein and several other people, it imposed the 50-employee cap that is now deemed by Trounson and others to be endangering the quality of the work at the organization. CIRM wants the cap removed, but that will require an unlikely feat – agreement of 70 percent of both houses of the legislature and the governor. CIRM's top leadership also recently indicated that it would oppose the only legislation to eliminate the cap.

Big run-ups in unused time off also reflect an organization's inability to perform routine tasks routinely. When the staff's energy is often consumed by last minute and late hour scurrying-about, it leaves little room to deal with genuine emergencies or allow time for thoughtful analysis. In the case of CIRM, where careful thinking should be valued, it has prevented its science officers and others from staying in the forefront of the stem cell field through attendance at key scientific conferences. CIRM has declared the importance of such efforts and has budgeted generously for them. But much of the funding remains unused.

Some CIRM directors also have worried publicly about staff burn-out. The fact that 22 former employees are on the list of those receiving time-off payments may be evidence for that concern, given that the staff size has probably averaged somewhere in the 30s for the past five years. One can only wonder why more persons were not hired early on. But hiring itself is a time-consuming process, one that CIRM's top executives may have found difficulty in finding time for.

Hard work and diligence should be recognized. CIRM should also recognize that it cannot and should not rely on its employees to give up regular vacations and time off to burn the stem cell candle at both ends.

Stem Cell Agency Launches High School Education Effort

The California stem cell agency this week announced its online high school study program, which is aimed at helping to provide workers for the biotech industry.

Art Torres, co vice chairman of the stem cell agency, said that California is "a fertile ground for stem cell science," but added that to "realize the full potential of this burgeoning field" requires development of "an educated workforce."

In a news release, CIRM said the high school science program provides “a robust source of educational materials with a wide variety of teaching formats and levels of presentation.” Four units were provided on the CIRM Web site. The agency said the program can be taught in a day or fill a week. Another component is in development.

The program is tied to legislation that requires the state Department of Education to post on its Web site the model curriculum launched by CIRM.

In response to a question, Don Gibbons, chief communications officer for CIRM, said the program cost $45,500 to produce, including the component under development.

We also asked about CIRM's outreach to promote use of the program and whether the agency had an email list for all high school science teachers in the state.

Gibbons replied,

“We previewed it (the program) at the Nat. Bio Teachers Assoc. last November in Denver. The California chapter of that group is just forming and we will ship materials to their organizing meeting in two weeks in Roseville. We developed a list of county science coordinators around our school outreach for Stem Cell Awareness Day and will be reaching out to them, as well as the 50+ teachers who asked for a CIRM researcher guest lecture that day. The state has a master site for high-speed access to on-line resources and we will be posted there. We will be seeking to present at the Cal Sci Educ Conf this October. Etc.”

The CIRM announcement was covered Thursday by the San Francisco Business Times in a brief article by Ron Leuty.

CIRM Directors to Take Position on Affordability, Accountability Measure

Directors of the California stem cell agency on March 4 will take their first public look at new legislation aimed at ensuring affordable access to therapies financed by taxpayers, including proposals to improve accountability and openness at the state research effort.

Also on the table at the meeting of the directors' Legislative Subcommittee is legislation to create a state board to deal with umbilical cord-blood matters.

Already three leaders on the CIRM board, Chairman Robert Klein, vice chairmen Art Torres and Duane Roth, have publicly opposed the affordability and accountability legislation as unnecessary. The CIRM board has successfully resisted every effort over the last few years by lawmakers to make changes in agency operations.

However, this year CIRM has declared that it needs to bypass the voter-approved limit on its staff at 50 persons, an action that the legislation would allow. The restriction was written into the law via Prop. 71 by Klein and others along with caps on agency spending. On the surface, removing the cap would seem to require a 70 percent vote of the legislature, also imposed by Prop. 71. But Klein says the agency is considering unspecified alternatives that would not require a vote of the legislature to avoid the restriction.

Earlier this month, Sen. Elaine Kontominas Alquist of San Jose, chair of the Senate Health Committee, introduced the accountability legislation (SB1064), declaring that CIRM is “essentially accountable to no one.” Introduction of the measure followed recommendations from a sister state panel to CIRM, calling for increased openness and transparency. The action apparently triggered two harsh newspaper editorials concerning CIRM.

The umbilical cord blood measure (AB52) is authored by Assemblyman Anthony Portantino, D-Pasadena. In addition to creating a new state board beginning next January and raising fees on copies of birth certificates to fund it, the measure specifically mentions CIRM. It says,

"California pioneered the first sibling donor cord blood pilot project, and is a world leader in the more general area of stem cell research and its medical applications through the establishment and funding of the California Institute of Regenerative Medicine (CIRM). This makes California ideally situated to become the leader in harnessing the therapeutic potential of nonhematopoietic cord blood-derived stem and progenitor cells."

In addition to the Legislative Subcommittee location at CIRM headquarters in San Francisco, the public can participate in the session at teleconference locations in La Jolla, Davis and Menlo Park. The specific addresses should be posted on the agenda in the next day or two. Comments also may be submitted to the board via email.

CIRM Director Azziz Looking to Move to Georgia

If you are interested in serving on the board of directors of the $3 billion California stem cell agency, you might want to get your application in early to Gov. Arnold Schwarzenneger. But if you don't work for Cedars of Sinai Medical Center in Los Angeles, you may be out of luck.

It appears that Ricardo Azziz, one of the governor's appointees, will soon be leaving for the Peach State. Azziz holds what might be called the Cedars seat on the CIRM board.

Azziz (see photo) is the only finalist for the presidency of the Medical College of Georgia, according to media reports this week in the Augusta Chronicle and on Channel 12 in Georgia.

In addition to serving on the 29-member CIRM board, Azziz is currently chairman of the Department of Obstetrics and Gynecology at Cedars-Sinai Medical Center in Los Angeles and serves as professor at the David Geffen School of Medicine at UCLA and vice chair of the Department of Obstetrics and Gynecology at UCLA.

Azziz has served on the CIRM board since September 2006. He replaced Keith Black, director of the neurosurgery at Cedars.

Cedars has received $5.7 million in grants from CIRM, out of the $1 billion the agency has given away in less than three years.

Azziz noted that the Georgia medical school was in “crisis.” He said,

"And that's really the best time when a leader can step in and add his or her feeling, add his or her flavor, to the direction of the institution. So I think it is as good a time as any and probably better than most."

Sort of the same situation that Obama had when he became president and what the next governor of California will have as well.

The current California governor has been slow in filling vacancies on the CIRM board, so it could be some months before a replacement is named. It is also not clear when Azziz would assume his responsibilities in Georgia.

CIRM Trio Says Alquist Legislation Creates Unnecessary Jeopardy

Three top leaders of the California stem cell agency today said new legislation aimed at making it more accountable and ensuring affordable access to taxpayer-funded therapies would instead jeopardize the agency's accomplishments.

In a word, they said, the measure is unnecessary.

Their opposition was delivered in a five-page letter to Democratic state Sen. Elaine Kontominas Alquist of San Jose, chair of the Senate Health Committee. She introduced the legislation earlier this week, declaring that CIRM was “essentially accountable to no one.”

The opposition letter was signed by CIRM Chairman Robert Klein, a Palo Alto real estate investment banker, and vice chairmen Duane Roth, a San Diego area businessman, and Art Torres, formerly head of the state Democratic Party and retired legislator.

They noted that the full, 29-member CIRM board of directors had not yet taken a position on the legislation. But they said in a letter on CIRM stationery that they wanted to “express our individual concerns regarding the bill’s potential economic impact on the state’s new tax revenues and new jobs created by CIRM.”  They declared,

“More importantly, we are concerned about the bill’s potential impact on finding treatments and cures for diseases and traumas that Californians struggle with everyday.”

Perhaps the key section of the letter, which was highlighted in boldface, said,

“In what is a model for all of state government, CIRM operates within a 6 percent cap on expenses – efficiency unrivaled even in the private sector. CIRM has placed California at the forefront of international breakthroughs in medicine without any net state general fund appropriations or debt service expenditures through December 2009. CIRM continues to serve Californians by advancing research and therapies, creating thousands of jobs, fostering the growth of the biotech industry, and generating over $100 million in new state revenue.”

The CIRM trio did not even endorse the legislation's removal of the 50-person cap on CIRM staff, which agency officials have said they sorely need. The three acknowledged that the restriction "poses challenges.”

But they said the board is “actively exploring other alternatives to address this and remains committed to the 6 percent cap on administrative expenses.” The letter did not elaborate on those alternatives and none have been discussed publicly. The cap was imposed by voters when they approved Prop. 71, which Klein often says he wrote.

The letter described CIRM as “California's most accountable state agency.” It said CIRM has given away more than $1 billion, mostly for research grants, and generated “tens of thousands of job years.”

The letter said that CIRM is already engaged in some of the activities that the legislation would mandate. That includes planning for changes at the top in December when Klein says he is going to leave, as well as planning for the time when the agency's remaining $2 billion will run out. So far, CIRM has handed out $1 billion in less than three years. The money comes from cash that the state borrows via bonds and flows directly to CIRM, untouched by the normal controls of the governor or legislature.

The letter said that the CIRM directors'  Legislative Subcommittee, chaired by Klein and including Roth and Torres, will meet soon to consider Alquist's legislation, SB1064.  The 10-member panel will make recommendations to the full board, which could take a position as early as its March 11 meeting in Sacramento.

Interested parties and members of the public will have a chance to personally address the board then. Individuals can also write or email the members of the board concerning the legislation.

The full letter, which is not on the CIRM Web site, can be found here.

State Lawmaker Says CIRM 'Accountable to No One'

A leading California state senator said today that the state's $3 billion stem cell agency is “essentially accountable to no one” and declared that more accountability and transparency are needed.

Sen. Elaine Kontominas Alquist, D-San Jose and chair of the Senate Health Committee, made the statement in a news release touting her legislation to help ensure that Californians receive a “fair return” on their investment, which will total $6 billion with interest.

Alquist said,

“I was an early supporter of California’s groundbreaking stem cell initiative, and know that our public investment on behalf of the State of California will lead to new frontiers of treatment to heal people with chronic diseases.

“However, CIRM is essentially accountable to no one given the way the initiative was written. Californians entered into a partnership with CIRM when they approved Proposition 71 in 2004, a partnership that was meant to be mutually beneficial. By accepting public bond dollars, CIRM also accepted public accountability, public transparency, and a public return on their investment.”

She continued,

“If a cure or life-saving medicine is discovered using taxpayer dollars, we must be sure that all Californians benefit from that research. Californians are the shareholders of this venture. In this economic environment, the Legislature has a duty to ensure that every public dollar is accounted for and spent wisely."

The news release highlighted three key provisions of her bill, SB1064:

• Ensuring Californians have affordable access to drugs developed by Prop 71 funds.
• Ensuring intellectual property revenue made from Prop 71 funded grants and loans return to the state’s General Fund.
• Requiring the Citizen’s Financial Accountability Oversight Committee and the Controller’s Office to conduct performance audits.

The bill would also lift the 50-person cap on CIRM staff, a change that the agency dearly desires. However, Alquist did not mention that proposal in the news release. (We should note that the cap is redundant because Prop. 71 also imposes a limit on administrative expenses.)

We asked CIRM on Wednesday for a response to the legislation, but nothing has been forthcoming. We will carry the agency's comments when we receive them.

For more details on the measure, see the “stem cell agency reform” item.

California Lawmakers to Weigh Stem Cell Agency Reform

Just a few weeks after a key state panel recommended more accountability and transparency at the $3 billion California stem cell agency, a leading California lawmaker has proposed far-reaching changes in  the five-year-old organization.

The measure – SB1064 by Sen. Elaine Alquist, D-San Jose – would require performance audits and thorough financial and leadership transition planning at CIRM. It would alter the selection of CIRM's top leadership, ban pre-judging grant proposals and funnel any royalty revenue away from CIRM.

The proposal may well avoid the dismal fate of past legislative efforts involving CIRM. Gov. Arnold Schwarzenegger vetoed those bills after stiff opposition from the agency. However, the measure by Alquist(left), chair of the Senate Health Committee, contains a large carrot for CIRM: removal of the 50-person cap on the size of the organization. The cap was written into Prop. 71 in an effort to make it more appealing to voters. But now CIRM says the restriction could endanger the quality of work at the agency and wants it changed.

CIRM had no immediate reaction to the legislation. It said a formal response was being prepared and would be available later today or tomorrow. Alquist's office also had no immediate statement available.

Asked for comment, John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said,

“Sen. Alquist's bill makes sensible adjustments to the California Stem Cell Research and Cures Act including requiring transition plans for leadership changes and the end of the current bond financing. The ICOC (the CIRM board) would be wise to embrace it. I hope I'm wrong, but I predict the wagons will be circled and this will once again be portrayed as threat to CIRM's very existence.”

The measure embodies many of the recommendations of the Little Hoover Commission, the state's good government agency. The Citizens Financial Accountability and Oversight Committee (CFAOC), a sister to CIRM, last month recommended adoption of some of the Hoover suggestions, declaring that the agency needed to be more open to the public. (Both CIRM and the CFAOC were created by Prop. 71 in 2004). The CFAOC action also appeared to have triggered two newspaper editorials and a column in the Los Angeles Times deploring CIRM's lack of transparency and accountability.

Among other things, the legislation would:

• Require grant recipients and their licensees to submit to CIRM a plan to assure affordable access to therapies developed using CIRM funding.
• Require that all revenues resulting from CIRM's intellectual policy agreements go into the state's general coffers instead of possibly into CIRM's treasury.
• Require development of a financial transition plan to be submitted to the governor and legislature. (CIRM has already committed one-third of its $3 billion in bond funding with another $300 million or so expected to be committed by the end of this year.)
• Require the state controller, the state's top fiscal officer, to commission annual, independent performance audits of CIRM at the agency's expense.
• Change the duties of the chair and president of CIRM, specifying that the chair does not engage in day-to-day management. The CIRM board would be given authority to decide the chair's responsibilities.
• Remove nomination of candidates for chair from statewide constitutional officers, such as the governor.
• Require CIRM to formulate a succession plan to deal with changes in its leadership. (The current chairman, Robert Klein, says he plans to leave his post in December.)
• Reduce the terms of the CIRM chair and vice chair from six to four years.
• Require all grant applications to go through CIRM's grant review group, which would end a pre-application triage that CIRM has been using.
• Require that meeting minutes include voting records of each member of the CIRM board.

The Alquist bill is likely to be changed as it wends its way through the legislature. It requires a 70 percent vote of both houses, a rare and difficult requirement for any piece of legislation.

We will carry CIRM's response and statements from Alquist when we receive them.

Attention Scientists: CIRM Is Changing Grant Rules

With little notice, the California stem cell agency is moving quietly to make significant changes that are likely to affect hundreds of scientists seeking a share in the $3 billion that the agency is handing out.

The matter comes under the innocuous heading of “submitting supplemental materials.” But just how successfully a competitor exploits the new procedures could have a major impact on whether his or her grant wins approval from the de facto decision makers, the CIRM grant review group.

The changes are scheduled to come up next Monday at a meeting in San Francisco of the grant group, the sessions of which are almost never attended by members of the public. The reason for the lack of attendance is that the sessions are devoted almost entirely to closed-door deliberations of applications.

However, in the case of the supplemental material matter, by law it must be considered in an open, public session. Interested parties may comment and make suggestions for changes. Although the agenda for the meeting makes no mention of the opportunity, any person or business can also send comments to the grants group in advance of the meeting and ask them to be considered.

The one-page justification for the grant application change and its provisions appears to have been posted last Thursday night (Feb. 11, 2010) on the CIRM Web site. However, no notice of the specific meeting or the proposed changes is provided on the home page of the CIRM Web site. That's in keeping with the standard practice of the agency, which tucks away notices on its Web site of its public meetings, even when they involve hundreds of millions of dollars in taxpayer funds.

This case and an earlier transparency failure involving the January CIRM board meeting followed a call last month by a key state panel for more openness on the part of the agency. The panel's recommendations appeared to have triggered two newspaper editorials and a separate column in the Los Angeles Times expressing deep concern about CIRM's lack of accountability. One editorial likened the agency to a “private fiefdom.”

As for the supplemental material plan itself, CIRM proposes a limited opportunity both in time and space for researchers to beef up their grant bids. The general idea is to provide an opportunity for submission of “critical new information” that has come up since the application was filed. It would include citations to journal publications and research “accepted for publication” but not yet published. Also to be permitted would be a single page of “preliminary data” related to the proposed project along with two letters of support for “new collaborations.”

The entire CIRM proposal can be found here.

No Ten Year 'Sunset' on CIRM Horizon

California's unprecedented, $3 billion stem cell research program is widely perceived as a 10-year effort, but, like much conventional wisdom, that view is simply wrong.

The agency, created as the result of a 2004 political campaign, theoretically could continue to function for eons. The only relatively immediate, “life-and-death” question facing CIRM involves the cash needed to continue its grant and loan programs, which have already pumped out $1 billion to California researchers.

The fiscal hitch comes from Prop. 71, the initiative that spawned the California Institute for Regenerative Medicine. The measure provided for only $3 billion in state bond funding. When that borrowed money runs out, CIRM will have to find more -- if it wants to continue operations. But CIRM does not, in fact, face a mandatory “sunset” provision that will bring down the curtain on its offices near the San Francisco Giants baseball park.

Mainstream news organizations have continued, nontheless, to describe the state's stem cell research as a 10-year effort, including at least two reports in recent months.

The error seems to stem from the 2004 campaign, when it was in the interest of Prop. 71 supporters to allow voters to believe that they were not voting to create a big-bucks bureaucracy that would exist in perpetuity. The campaign was run by Bob Klein, who wrote much of the ballot measure and who is now chairman of CIRM.

News stories at the time commonly described the measure as having a 10-year limit. Those stories went uncorrected, presumably because the Prop. 71 campaign did not want to make an issue of it. In fact, the Prop. 71 campaign Web site carried this statement:

“Funds will be allocated incrementally over 10 years (~$295 million per year) for California-based stem cell research at leading universities and research institutions.”

The campaign Web site has now vanished into cyberspace and its domain name is for sale. But the campaign document can be found on the Web site of the world's largest organization of stem cell researchers, the International Society for Stem Cell Research. The society reports to this day that California is engaged in a 10-year program.

Last week, we discussed CIRM's life expectancy with James Harrison, the agency's outside attorney, at a meeting of the CIRM board at the Hotel Whitcomb in San Francisco. He assured us that there is no “sunset” looming for CIRM.

Later we asked him to provide his perspective via email, the full text of which is in a separate item below. Harrison is with Remcho, Johansen & Purcell of San Leandro, Ca., and is one of the authors of Prop. 71. He said,

"We wrote Prop. 71 to protect the voters' mandate against ideologically motivated litigation that could deny Californians the opportunity to have ten full years of medical and scientific advances for therapies. With ten full years of funding, the public will have an opportunity to evaluate CIRM's performance and the value of Prop. 71 to California's patients and the health care budget. At the end of this period, CIRM expects to be able to demonstrate an extremely persuasive performance.”

Harrison continued,

"Numerous (media) interviews were given to explain how Prop. 71 would adjust for delay by extending the effective time frame. Similarly, many interviews focused on the ability to reduce funding in a particular years if the scientific quality dropped in that year, with the funds saved to be used in later years, perhaps adding a year or two to the program term."

The California voter pamphlet, which goes to all registered voters statewide, also said in 2004,

“The measure states its intent, but does not require in statute, that the bonds be sold during a ten-year period.”

The pamphlet, however, came during both a presidential election year and a California election that was loaded with ballot measures. Both voters and reporters paid scant attention to it.

As for the language in the “intent” section of the measure, it says that Prop. 71 would

“Authorize an average of $295 million per year in bonds over a 10-year period to fund stem cell research and dedicated facilities for scientists at California’s universities and other advanced medical research facilities throughout the state.”

As far as we can tell, that is the only reference in the 10,000-word measure to a 10-year limit.

So what does all this mean? The intent language and the campaign's action/inaction could encourage a cantankerous attorney to make legal mischief by arguing in court that CIRM must wind up its affairs within the decade specified. We suspect such an effort would fail, but it would waste time and money at CIRM.

More importantly, the matter touches on the agency's credibility, which is likely to be examined as part of its bid for future funding. CIRM has already embarked on a course (creation of a communications task force and its disease team grants) to gin up support for more cash. If CIRM's credibility is suspect, some potential benefactors – be they lawmakers or philanthropists – may view the agency's new pitch with skepticism.

Klein already has been labeled as less than straightforward in connection with campaign claims. In one case involving allegations of deceit, the San Francisco Chronicle reported that Klein failed to disclose during the campaign negative financial details to the tune of $1 billion. Klein did not respond publicly to the 2005 article.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., today put CIRM's life expectancy in the broader context of the California's budget crisis.  Writing on his organization's blog, he said that when CIRM asks for more public cash,

"...(It) will be necessary to ask whether, after committing $6 billion, counting interest on taxpayer money, CIRM deserves more.  The question will be: Given California's other challenges, can it afford more money for stem cell research?  I don't know what the answer will be then.  If the choice were being made today, my answer would be definitely not."

(You can read recent news stories here and here that contain a reference to a 10-year program. You can read campaign news stories that contain a reference to 10 years here, here and here. The item below carries the verbatim text of what Harrison sent the California Stem Cell Report concerning the life expectancy of CIRM.)

Statement on CIRM's Life Span From the Agency's Counsel

Here is the text of the statement to the California Stem Cell Report from James Harrison of Remcho, Johansen &  Purcell of San Leandro, Ca., CIRM's outside counsel, on the life expectancy of the stem cell agency. 

"We wrote Prop. 71 to protect the voters' mandate against ideologically motivated litigation that could deny Californians the opportunity to have ten full years of medical and scientific advances for therapies. With ten full years of funding, the public will have an opportunity to evaluate CIRM's performance and the value of Prop. 71 to California's patients and the health care budget. At the end of this period, CIRM expects to be able to demonstrate an extremely persuasive performance.

"To permit this evaluation to occur and to protect against delays arising from events beyond the agency's control (such as the litigation, which delayed the program for two and one half years), the measure was drafted to provide some flexibility. Thus, the measure sets forth limits on the percentage of funds that the agency can commit over the first 10 years of grant making (section 125290.70(a)(1)(B)), but permits funds that are not allocated in a particular year to be carried over to the following years. Likewise, the bond act authorizes the issuance of $350 million per year in bonds, but permits any remaining amount to be carried over into subsequent years. (Section 125291.45(b).)

"To date, CIRM has committed approximately one billion and expects to commit the remainder over the course of the next 7 years, which is consistent with the ten year time frame, as adjusted by the delay caused by the litigation. Of course, if there are other delays, such as federal regulatory roadblocks or other events beyond CIRM's control, this time frame could be extended.

"The loan program could also extend this time frame. To extent that CIRM recovers money from the loan program, the funds will be used to make new grants and loans to help successful proofs of concept reach patients, thereby providing the voters with more research funding than they've paid for.

"Throughout the campaign, the proponents of Prop. 71 explained that it was their intent for the funds to be committed over a period of ten years to permit the voters to evaluate the agency's performance, but they noted that if there were delays, the measure was designed to permit ten full years of funding as a basis for evaluating the value of Prop. 71.

"Numerous interviews were given to explain how Prop. 71 would adjust for delay by extending the effective time frame. Similarly, many interviews focused on the ability to reduce funding in a particular years if the scientific quality dropped in that year, with the funds saved to be used in later years, perhaps adding a year or two to the program term."

Eugene Washington to Join CIRM Board

An academic executive who was a key figure in developing UC San Francisco's first-ever strategic plan is scheduled to become the newest member of the board of directors of the $3 billion California stem cell agency.

He is A. Eugene Washington, who became dean of the UCLA School of Medicine this month. Prior to assuming the job, he was executive vice chancellor, provost and professor of gynecology, epidemiology and health policy at UCSF. In 2005, he co-chaired the development of UCSF's first campus-wide strategic plan.

Mona Gable profiled Washington in a piece last month in UCLA Today. She quoted Nancy Adler, vice chair of the UCSF Department of Psychiatry and director of the Center for Health and Community, as saying,

“He has a capacity to see things in innovative ways and to get people to work together to do things. He’s really a consensus builder. Sometimes that can be waffly, but his capacity to have a strong vision and bring people along to share in it, rather than impose it on them, is what characterizes him.”

As executive vice chancellor, he oversaw areas dealing with conflicts of interest, industry contracting and information technology in the UCSF office of research. That experience may serve him well given CIRM's enormous reliance on outside contracting and its ongoing issues with its grant management system.

Washington's appointment has not been formally announced, as far as we can tell, although it was discussed at last week's CIRM board meeting. His predecessor, Gerald Levey, the former UCLA dean of medicine, has retired. However, Levey, who has been on the CIRM board since its first meeting, will be serving as Washington's alternate on the 29-member CIRM board. Given that situation, it is unclear whether Washington will be in regular attendance at CIRM.

Southern California Newspaper Calls for Greater Transparency at CIRM

Another negative newspaper editorial popped up this week concerning the California stem cell agency. The piece called for more accountability and openness on the part of $3 billion research effort. And, the editorial said, if the agency goes to court to fight reforms, lawmakers should place the proposals on a statewide ballot.

The article in the Riverside Press Enterprise cited recommendations from the Little Hoover Commission, the state's good government agency, and the Citizens Financial Accountability and Oversight Committee, a sister agency to CIRM. Most recently, the citizens committee last week called for some reforms, a move that triggered a less than favorable column – for CIRM – in the Los Angeles Times, the state's largest paper, and a harsh editorial in the San Diego Union-Tribune.

The Riverside editorial said,

“California's stem cell research agency is not a private fiefdom, but a public entity answerable to taxpayers. Legislators should follow the recommendations of a state watchdog, and impose rules that would bring accountability and openness to an agency spending $3 billion of public money.

“Those steps should start with restructuring the agency's governing board to provide more independence, reduce conflicts of interest and hold members responsible for their actions. And the Legislature should oblige the agency to make decisions more transparently when awarding research grants.”

The piece continued,

“...(N)ot surprisingly, the institute has been dogged by widespread suspicion of conflicts of interest. The agency says that board members abstain from voting on matters that affect them. But the need for frequent recusals suggests an inherent structural flaw in the board,

“How the agency disburses money is largely hidden from public view, as well. The institute only identifies those grant applicants who collect money. But publicizing all the applicants, not just the successful ones, would protect against self-interest or favoritism in funding decisions. Connecticut's stem cell program follows that practice, and so should California's.

“The stem cell institute claims that most of those reforms would require a new ballot measure, but that argument is suspect. The measure allows the Legislature to make changes that further the intent of Prop. 71. Steps that provide greater public trust and protect against insider dealing surely further the agency's mission -- not to mention the public interest.

“And if the agency goes to court to fight such reforms, the Legislature should simply put them on the ballot.”

CIRM Financially Secure Into Summer 2011

SAN FRANCISCO – Directors of the California stem cell agency today heard some good financial news – $55 million worth – that will keep them out woods through the summer of 2011.

John Robson, CIRM's vice president for operations, reported that the agency has enough cash on hand to pay for its grants and operations into the first quarter of the 2010-11 fiscal year. Previously, he had predicted that money would run out around June of 2011.

Robson explained that much of the additional cash was discovered as a result of closer accounting of the results of a state bond sale in spring 2009. Additional cash became available because of delays in completion of four stem cell labs that are partially funded by CIRM. He also said more accurate financial information is being generated by a new grants management system.

CIRM relies on state bonds for its funding. Presumably it will receive another jolt of cash in the next 18 months as the result of additional bond sales.

Robson additionally reported that the Buck Institute, which has not been able to raise matching funds for its $21 million CIRM lab grant, has decided to begin construction regardless. Robson said that if Buck does not receive $15 million in matching funds from federal stimulus cash or philanthropy, it has decided to take on additional debt for the project.

CIRM Directors Change Big Biotech Loan Program

SAN FRANCISCO – Directors of the California stem cell agency tonight approved changes in the terms of its $500 million biotech loan program with little discussion and no dissent.

Approved were the guidelines that can be found here. Elona Baum, CIRM general counsel, highlighted some of the changes from the previous loan terms. They included lowering the minimum size of a loan below $3 million under some circumstances, designating the default interest rate as LIBOR plus 2 percent and compounding interest instead of using simple interest.

The changes also included new terms for use of warrants as part of the loan process and acceleration of loan payments in the event of a change of control, at CIRM's discretion. Also approved were extensions of loans beyond five years up to 10, with payment of 25 percent of accrued interest and an increased interest rate each year. Loans could be extended beyond 10 years with approval of the directors' Finance Subcommittee.

No biotech businesses or members of the public commented on the changes. The loan terms are guidelines. CIRM staff is preparing a final Loan Administration Policy.

Also approved by CIRM directors were:

Initiation of a $40 million grant round for “tools and technology”

Regulations dealing with CIRM research standards

Creation of a directors Scientific Issues Subcommittee, but no members were named

Put off until March was a proposal for CIRM to begin to fund at least part of clinical trials. No details were available from CIRM.

The CIRM board briefly discussed last week's meeting of a key state panel that urged it to be more open, transparent and accountable. Among other things, the Citizens Financial Accountability Oversight Committee recommended that CIRM post online the statements of economic interest and travel expense claims of its board members and top management. Some members of the CIRM board said the committee's recommendations were not based on factual information.

The board also discussed a scathing San Diego Union-Tribune editorial this morning and generally expressed a desire to be able to respond quickly to negative articles. Some board members also expressed dismay that they had not been given a copy of the editorial early in the day. Duane Roth, a San Diego businessman and a CIRM director, has written a letter in response to the San Diego paper that he said he expected to see published this week.

(Editor's note: An earlier version of this item did not contain the sentence concerning board members dismay about not receiving a copy of the editorial earlier.)

Public Can Participate Today in CIRM Board Meeting at Locations in San Francisco, San Diego and Los Angeles

Biotech executives, researchers and the public can participate in today's meeting of the board of directors of the California stem cell agency at locations in San Francisco, Los Angeles and San Diego.

It may be the first time that three such widespread locations have been available around the state for a CIRM board meeting. The sites are the Hotel Whitcomb in San Francisco(where the meeting is based), the Lansing Foundation in Los Angeles and the Salk Institute in La Jolla in the San Diego area.

Interested parties can listen in as well on the meeting today and tomorrow via the Internet. However that connection is one-way only. It does not provide for comments from the public.

If you are interested in the sites in San Diego and Los Angeles, check in advance with the Lansing Foundation and Salk to be sure that you know more specifically where the teleconference connection is located.

Here are the procedures for using the Internet. Today's broadcast begins at 4:30 p.m. PST. Listeners should go this Website http://65.197.1.15/att/confcast and use conference ID# 141973. The broadcast Thursday begins at 8:30 a.m. PST. Use http://65.197.1.15/att/confcast and conference ID# 141977.

Scathing Commentary on CIRM from San Diego Union-Tribune

The San Diego Union-Tribune today blistered the California stem cell agency in an editorial calling for greater transparency and a "much less blithe attitude about conflicts of interest."

The editorial carried the headline: "Stem-cell shenanigans / Lawmakers should force state institute to shape up." The San Diego paper said,

"This reeks. It increasingly appears as if the Legislature needs to save CIRM from itself. The institute’s good work does not excuse its machinations."

The Union-Tribune, whose circulation area includes one of the nation's hotbeds of biotech, said that it supported Prop. 71, the measure that created the stem cell agency in 2004, and has backed the agency since then .

The newspaper continued,

"Nevertheless, a June 2009 report by the Little Hoover Commission, a state watchdog group, made a strong and convincing case that CIRM had fundamental conflict-of-interest problems. Those overseeing CIRM often also won grants from the agency.

"Dismayingly, CIRM dismissed the criticism out of hand, which only raised more eyebrows. This is not how a public agency is supposed to act when legitimate ethical concerns are raised by a respected public watchdog.

"Now, however, the Legislature has the opportunity to compel CIRM to take these concerns seriously. Institute officials say they are hamstrung by a provision in Proposition 71 that puts a 50-employee limit on CIRM and are asking for a change in state law.

"Lawmakers must do so only if the legislation also includes specific provisions requiring much more transparency in how management and grant decisions are made and a much less blithe attitude about conflicts of interest."

The Latest on Changes in CIRM's Biotech Loan Program

CIRM today reported another change in what is to be expected concerning alterations in the $500 million biotech loan program at tomorrow's and Thursday's meetings of its board of directors.

In an email, Don Gibbons, CIRM's chief communications officer, said,

“There is a bit of change again in the agenda. We decided that we needed the loan term guidelines for the Early Translational RFA and that the phone meeting of the board could not happen prior to posting that RFA. So the original agenda item has been split in two, the actual amendments to the loan administration policy will occur at a later meeting, but the term guidelines will be up for approval as related to the early translational RFA.”

Advisory

The link in the "Fecundity" item today was faulty. It has now been fixed.

Fecundity, Stem Cells and the Dark Side of Prop. 71

Los Angeles Times columnist Michael Hiltzik has provided a bit of a filip to his look Monday at the California stem cell agency.

It came in the form of an entry in his blog entitled “Of stem cells and administrative arrogance.”

Among other things, he said Prop. 71, which created California's $3 billion research effort, was “too specific about how the program would be managed and how it would spend its money -- embryonic stem cell research was placed front and center at a time when that line of research was so, well, embryonic that no one could tell how fecund it might be.”

Hiltzik also said,

“Prop. 71 is an excellent illustration of how the state's initiative process can lead to doing the wrong thing with the right intentions. Now that many other research vectors are proving more interesting, the California Institute for Regenerative Medicine is at a crossroads, only five years after it was launched. Its latest major round of grants included some that had little to do with embryonic stem cells; it's moving away from basic science grants toward lending to commercial firms; its 10-year sunset deadline is fast approaching, with no one sure whether its lifespan should or can be extended; and real and potential conflicts of interest involving its board members and grant applicants continue to exist.”

“Now,” he said, “even Prop. 71 itself is in the program's way.”

A footnote on the sunset comment: The organization itself does not terminate after 10 years. Rather it loses its ability to issue state bonds.

(Editor's note posted Feb. 8, 2010: Section 3 of Prop. 71 states that the intent of the measure -- and "intent" is the key word -- is to

"Authorize an average of $295 million per year in bonds over a 10-year period to fund stem cell research and dedicated facilities for scientists at California’s universities and other advanced medical research facilities throughout the state."

(The outside attorney for the board says there is no legal time limit on the board's bonding abilities, just the total amount of the bonds, $3 billion. We will soon post an item discussing at more length the misperceptions about CIRM's life span.)

CIRM Delays Action on Clinical Trials, Biotech Loan Changes

The California stem cell agency today said its directors would put off until their March meeting a discussion of a proposed foray into financing of clinical trials.

CIRM also said that directors would not vote this week on changes in its $500 million biotech loan program. Instead they are expected to act later on the proposal during a special telephonic meeting.

Both topics are on the agenda for this week's meeting in San Francisco, which begins on Wednesday and continues on Thursday.

In an email, Don Gibbons, CIRM's chief communications officer, said, “Chill on the (agenda) documents. The clinical RFA discussion is being put off until the March board meeting and the loan program vote will be at a special telephonic board meeting after everyone has had a chance to review the minor changes made by the finance subcommittee. Both these agenda alterations have been in the works for a few days, I just needed to verify them.”

Earlier posts (here and here) on the California Stem Cell Report have noted that CIRM had not posted an explanation of or a justification for the loan changes. CIRM also has not laid out just what is being proposed in the clinical trial venture. All of which makes it quite difficult for researchers, biotech businesses and the public to offer any sort of well-considered comment prior to board action.

The proposed loan guidelines, however, were posted today, but still missing is an explanation of why they are needed or exactly how the changes departed from the original plan.

Also posted today, under the topic of membership of a directors Scientific Issues Subcommittee, was a 12-page report on the prescreening process in use at the agency for some grant rounds. The report included a survey of 117 applicants.

The report said, in part, that “the results suggest that applicants, PreApp (preapplication) reviewers and GWG (the scientific grant review group) reviewers favor this process. The process has created an opportunity for many applicants to compete that have not previously applied to CIRM and a significant number of these have succeeded in acquiring a grant. The process allowed us to consider more proposals within a single review cycle than would have been possible using conventional review.”