Hope and Home Runs: Nature and the Chron on the California Stem Effort

It wasn’t exactly a stem cell tag team, but both the journal Nature and the San Francisco Chronicle this past week carried lengthy pieces examining the state of affairs at California’s $3 billion stem cell agency.

 Neither of the articles was a valentine, but overall the agency should be satisfied with them -- if only for the reason that they will make more people aware of what the agency is doing. The agency received something of a cyber bonus with a video on the Nature Web site that accompanied its online article(see video above). Coverage of the agency, especially in the mainstream media, has been minimal over the last several years.

 Meanwhile the agency has been trying to spread the word as it tries to fend off its financial demise in less than three years, when funds for new research awards run out. 

Both pieces covered familiar ground for readers of this Web site. And both emphasized the looming financial crunch for the agency, which is examining the possibility of some sort of private-public financing arrangement. The agency has not ruled out another bond measure to secure voter approval for as much $5 billion in additional financing. Neither article discussed the likelihood of voter approval, which is problematic. 

Both pieces took a run at providing summaries of the work that the agency has financed and its contributions. Both noted that the agency has yet to produce a stem cell therapy despite the apparent promises of the ballot campaign 10 years ago that created the agency. 

Erika Check Hayden, who wrote a Nature overview of the agency in 2008, was the reporter again on the latest article on July 2.  It was headlined, 

"Stem cells: Hope on the line"

The subhead said,

“A decade ago, voters in California changed the biomedical research landscape by directly funding embryonic stem-cell research. Now the organization they created needs a hit to survive.”

Hayden wrote,

“The institute has navigated a difficult path, however. CIRM had to revamp its structure and practices in response to complaints about inefficiency and potential conflicts of interest. It has also had to adapt its mission to seismic shifts in stem-cell science.

A "home run" is now in order in the words of agency board member Sherry Lansing, the Nature article said.

Hayden interviewed former agency chairman Robert Klein about his plan for a $5 billion bond measure, perhaps in 2016. She quoted Klein as warning that the nation and California could see a “theocratic government” in the near future that would endanger research. Hayden wrote that Klein said,

“We have to protect science's access to the full range of cellular types now. And in doing that, we will protect the freedom of science to ethically pursue knowledge in this country outside of religious ideology.”

Klein also said,

“If we don't take a position now the next ten years may see a theocratic government at the state and federal level that restricts scientific research in this country for the next 50–100 years.”

As for the agency’s accomplishments, Hayden wrote,

“(I)n California, researchers are making nerve, heart, eye and skin cells from iPS cells and embryonic stem cells — a range of work rare for a single state — and they aim to test many of these in humans. They are developing drugs against cancer stem cells, which are thought to perpetuate the disease. And they are leading the world's only two trials of treatments that combine gene editing and cell therapy to treat HIV. They are doing all this with an unmatched infrastructure, including a network of 12 new or newly renovated facilities, and a funding pipeline that acts as a beacon to young scientists.

“Almost every country would be jealous of what they've got in California,” says Christine Mummery of the Leiden University Medical Center in the Netherlands.”

Mummery is a member of the agency's scientific advisory board.

Stephanie Lee was the writer on the San Francisco Chronicle story that was on the first page of the business section on July 5.

It was headlined,

“Stem cell researchers under pressure to produce”

The headline was drawn from this paragraph by Lee,

“Fund recipients are under pressure to show results - commercially viable therapies, ideally. Universities and other nonprofit groups have received most of the money, but the pressure is especially heavy on biotechnology companies that have staked their livelihoods on such therapies."

Lee mentioned StemCells, Inc., (along with photos at the company’s lab), Asterias, Capricor, Calimmune and ViaCyte as companies that are making progress.

 She continued,

“As (clinical) trials add more patients, they become more expensive. The challenge in the future will be to find money to keep these trials going when the stem cell agency runs out of money.

"’It's certainly not going to make life easier,’ said (Martin) McGlynn (CEO) of StemCells, which reported a $28 million operating loss last year."’To their credit, the California voters stepped up to the plate, and $3 billion is a lot of money,’ he said. ‘But an awful lot more is going to be needed to finish the job.’"

Lee continued,

“It is not realistic to expect a stem cell therapy to reach consumers in five years, especially when the field is so young, said Enal Razvi, managing director at Select Biosciences, a life sciences market research company.

"Even so, by 2017, ‘if they don't have products already on the marketplace, they should not be expecting public money to fill their portfolio,’ he said. ‘Apple doesn't go to California and keep asking for money to build their own iPhone.’"

Robert Klein, the California Stem Cell Agency and a $5 Billion Proposal

The California stem cell agency last week put a little distance between it and its former chairman, Robert Klein, who is currently touting a new, $5 billion bond measure to rescue the agency from its financial demise.

The agency's comments came in response to a news story about comments that Klein, a Palo Alto real estate investment banker, made at a symposium at UC San Diego's Moores Cancer Center.

Bradley Fikes of the San Diego U-T wrote a story on Feb. 20 about the appearance that was headlined “$5B initiative proposed for stem cell research.” Fikes said,

“Supporters of California’s multibillion-dollar stem cell program plan to ask for $5 billion more to bring the fruits of research to patients.”

Fikes reported that Klein said “he’s going to be talking with California voters about the proposal. If the public seems receptive, backers will work to get an initiative on the 2016 ballot to extend funding for the California Institute for Regenerative Medicine(CIRM).”

Klein, who left the agency nearly three years ago, has talked for several years about another bond measure on top of the $3 billion, 10-year borrowing effort approved by voters for CIRM in 2004. His latest statements are the first in which he has publicly specified a figure.

In the wake of Fikes' story, the California Stem Cell Report asked the agency for a comment on Klein's remarks and his current role at the agency. Kevin McCormack, senior director for communications, replied Friday,

“Bob has been talking about a new bond initiative for a couple of years now so this is not altogether surprising. However, our focus remains where it always is, on our mission and the progress that is being made by CIRM-funded researchers to find new treatments and cures for patients, and we are continuing to explore avenues to sustain that progress.”

Currently the agency is looking into some sort of public-private arrangement that could finance its operations beyond 2017, when funds will run out for new awards. The 2004 initiative limited the agency's $3 billion bond authorization to only 10 years. CIRM is counting the 10 years as beginning from the date the first bonds were sold.

So far, the assumed public contribution for CIRM's future is a fraction of what Klein is touting – only $200 million.

Klein's public appearances around the state talking up another bond measure raise questions about how his efforts fit with the planning of the agency itself and the financial explorations of the current chairman, Jonathan Thomas, a Los Angeles bond financier, and other members of the CIRM board. California policy makers, potential wealthy donors, foundations and corporations may well be confused about whether Klein is speaking for the agency either directly or indirectly.

Given McCormack's carefully worded statement, it is reasonable to assume that CIRM is not entirely enthusiastic about Klein's bond measure pronouncements.

Additionally, premature discussion of more state borrowing, which has been criticized by Gov. Jerry Brown, could lead to a hardening of positions at an early stage. In 2011, when Klein initially broached another bond issue, the San Jose Mercury News said in an editorial,

“What planet are these guys from?....Going back for more would make no sense regardless of the economy....”

Tobacco Taxes and Stem Cells: Backers Still Not Talking, Questions Raised

Backers of a proposal that could rescue the $3 billion California stem cell agency from financial oblivion remained mum today as questions arose about the viability of the possible ballot measure.

The plan would raise roughly $700 million annually by increasing tobacco taxes, channeling about $200 million to the stem cell agency through a ballot initiative that would have to be approved California voters. The stem cell agency is scheduled to run out of cash for new awards in 2017 and is casting about for new sources of funding.

However, CIRM, as the agency is known, was largely caught by surprise last week by the release of the details of the proposal, which was filed by prominent Orange County attorney Frank Barbaro, former chairman of the county's Democratic Party.

Barbaro has not responded to email requests for more information about the backers of the plan and their financial commitment to an electoral campaign. Backers of a similar proposal that was narrowly defeated in 2012, Prop. 29, said they knew nothing about the effort.

The latest measure could go on the November ballot this year or the general election ballot in 2016 if it qualifies. The timeline for November is daunting. Responding to a query from the California Stem Cell Report, Sacramento political consultant Jeff Raimundo said in an email,

“Sounds like most people didn’t know this was coming. An Orange County attorney filing an initiative with no known backers?  Hmmm…formula for failure? 

“If stem cell agency folks didn’t know about it (and there’s no real reason to believe they did) and the cancer-fighting community had no knowledge, it’s hard to figure out how proponents are going to muster support from voters who only two years ago rejected a similar proposal from a more transparent and credible group. Prop. 29 barely failed, but it had a big push from advocacy organizations. 

“Too many questions right now to get a good handle on how effective such a campaign might be  -- who the REAL sponsors are, who would put up the money for the campaign, whether the OC attorney is a shill for someone else, whether those who back CIRM and its research role can be persuaded to back a new proposition. Many more initiative proposals are filed than are ever circulated. And many more are circulated than ever actually make the ballot in Californa. They’ve got a long way to go and not a lot of time to get there.”

The agency said last week that it has not endorsed the plan. Directors have not yet had a chance to consider it during a public meeting.

But CIRM Director Francisco Prieto, a Sacramento physician, told the California Stem Cell Report,

“I wasn’t aware of the tie-in to CIRM funding before (Friday). I don’t think they asked us first, but I’d be happy to see it pass, of course. I’m in favor of so-called 'sin taxes' – including those I pay when I support California’s wine industry. Raising the price of tobacco is one of the single most effective things that we can do to reduce smoking rates, especially among young people who are the most price sensitive. As the guy who has to sign the death certificates, I’m in favor of anything we can do to reduce smoking.”

Another CIRM director who responded to our queries, Jeff Sheehy, a communications manager at UC San Francisco, said that conceptually the proposal could make sense.

 "It's a better source of funds.  However, it does create a well-funded opposition campaign.  Still trying to  figure out if this is a good thing or not," Sheehy said.

Other board members as well said they had no advance knowledge of details of the measure.

Robert Klein, the former chairman of the agency, also responded, saying that that he was not involved in the proposal. He said he questioned the structure and funding approach but declined to elaborate.

Earlier last month we asked Klein about talk in the California stem cell community that he was involved in another bond measure effort for CIRM. Bonds are the current source of funding for the agency.

A spokeswoman for Klein replied,

“There is no campaign. We have done a single one scientific briefing on the progress of Proposition 71(the measure that created CIRM in 2004). It is strictly informational and does not constitute a campaign. We will decide in late 2015 what the next steps will be based on the scientific research at that time.”

Our take: In terms of the financial structure, Barbaro's tobacco tax proposal has at least one downside for CIRM. If the measure is successful in its goal of reducing smoking, the amount of money it raises from tobacco consumption will decrease. That, of course, would mean a dwindling amount of cash for the agency.

Launching a campaign for next fall's ballot would require a prodigious effort at this late stage even if some of the millions needed are already nailed down. The groups that backed the measure in 2012 are not likely to jump aboard immediately given their surprise at the latest proposal. They also may have other priorities as well at this point. Organizationally, work would have to begin now even though there is the possibility that not enough signatures could be gathered by the end of May to qualify for the fall ballot.

Opposition from the tobacco industry would be fierce. It raised $47 million in 2012 for its campaign compared to $12.3 million from the backers of the tobacco tax.

Stem Cell Board Nixes $13.4 Million to Help Cure Cartilage Disorders

Directors of the California stem cell agency today rejected a $13.4 million proposal that would have been the first disease team research that it has backed that would deal with cartilage disorders.

The project would have built on earlier research funded by CIRM. The agency staff cited work at UC Davis  by Kyriacos Athanasiou and at Scripps by Peter Schultz. Funding of the application was supported by the CIRM staff, which did not identify the applicant.

However,  the governing board, however, went along, on a 10-1 vote, with arguments by Director Jeff Sheehy and others that the agency had finite resources and had to make difficult decisions. He noted that many alternative treatments exist for cartilage problems. Sheehy said,

"We are here to make progress on serious diseases and conditions."  

Former Chairman Robert Klein, in an unusual appearance as a member of the public, urged approval of the grant. He said that it would address conditions "very prevalent in the older population."  Klein told the board that the research would be a "very important milestone that will help you get more money in the future."

While Klein did not mention it, older persons participate in elections to a much greater degree than younger persons. They would be an important group in winning support for another bond issue to fund CIRM, which runs out of cash for new grants in 2017.

Sharp Exchanges as Stem Cell Board Tables Future Funding Proposal

A plan to finance the California stem cell agency after its $3 billion runs out in 2017 was shunted aside today after it ran into sharp opposition and questions from several of the agency's governing board members.

Vice chairman Art Torres attacked the preparation of the report as "offensive" because none of the patient advocates on the board, of which he is one, were consulted in its preparation. He said the CIRM staff should have prepared the $150,000 report -- not a consultant. Torres said the issue of sustained funding for the agency is the responsibility of the Chairman Jonathan Thomas, not the outgoing President Alan Trounson.

Torres' heated remarks drew a sharp retort from Trounson, who summarized the report for the board and said it was part of his management goals. Trounson said that he considered Torres' remarks an "attack on me," an assertion that Torres denied.

Other board members, including Thomas, said the report requires further thought and testing. They said the new president, who will replace Trounson, should be involved. CIRM Director Jeff Sheehy, another patient advocate, moved to table the report and put it in the hands of Thomas with the proviso that no further funds be spent on it pending further action. Sheehy's motion was approved on a voice vote.

The report was aimed at dealing with the loss of state bond funding for the agency.  The report called for private-public partnerships that would mean closer ties to industries. The funding would undoubtedly be considerably less than the $300 million or so that the agency currently hands out annually.

The proposal would also mean a considerable change in the nature of CIRM's program, likely focusing even more on research that is close to the marketplace.

Another bond issue for funding the agency has not been ruled out by the agency. But taking it to the voters is difficult politically and financially. The initiative campaign in 2004 that created the stem cell agency cost more than $30 million.  Stem cell scuttlebutt has it that former CIRM Chairman Robert Klein is talking up another bond election and perhaps even raising campaign funds.

Here is a link to Trounson's Power Point presentation today.

Merksamer Makes Only Bid For Stem Cell Agency Lobbying Contract

Only one of California's lobbying firms is interested in working for the California stem cell agency – at least interested enough to put in a bid.

However, that is likely more of a function of the small size of the contract – $65,000 – and the entrenched nature of CIRM's existing lobbyist – Nielsen, Merksamer, Parrinello, Gross & Leoni LLP – one of the state Capitol's larger lobbying firms with $5 million in billings last year.

The firm touted its longstanding connection to the $3 billion agency in its 21-page proposal in response to a CIRM RFA this spring. The firm has been with CIRM since 2005.

Nielsen Merksamer's proposal also noted a couple of other interesting aspects of the continuing arrangement. CIRM will run out of money for new grants in 2017, and Nielsen Merkasamer said,

“Furthermore, as a premier legislative advocacy and (Nielsen's italics) ballot measure law firm, Nielsen Merksamer can actively and effectively assist CIRM as it contemplates returning to the voters for additional funding.”

The proposal also suggested that it can conceal information that normally would be public record. The firm said,

“Another unique advantage offered by Nielsen Merksamer is that, unlike the vast majority of lobbying firms, since we are a full-service law firm, our relationships with our clients are subject to the attorney-client privilege.”

CIRM used such a technique in 2012 and 2008 in matters involving its budget and PR advice.

Nielsen Merksamer also said,

“(N)o one understands CIRM’s 'total picture' better than Nielsen Merksamer. Not only has Nielsen Merksamer been representing CIRM before the Legislature for the past decade, but Nielsen Merksamer was also one of the principal drafters of the aforementioned Proposition 71—which brought CIRM to life. The depth of Nielsen Merksamer’s familiarity with, and understanding of, CIRM’s mission and structure, the challenges it faces, and the promise it holds simply cannot be matched by any other legislative advocate.”

The firm said it would not need the $65,000 offered by CIRM but would charge only $49,200 annually, about the same as it has been paid for several years. Steve Merksamer and Gene Erbin, who drafted portions of Proposition 71, would handle most of CIRM's affairs. John Moffatt and Missy Johnson would also be available.

The firm's proposal outlined several instances where it successfully killed legislation opposed by CIRM. You can read about them in their proposal below.

Merskamer 2013 Lobbying Proposal by DavidJensen

Stem Cell Agency Chair Pressing for Consensus on IOM Recommendations

The chairman of the $3 billion California stem cell agency, Jonathan Thomas, yesterday outlined how he intends to proceed next week when the agency's governing board considers the far-reaching recommendations of a blue-ribbon Institute of Medicine panel.

Writing on the agency's blog, Thomas said,

“While some of the IOM’s recommendations are administrative in nature and can be implemented, others are much more complex and would require changes in (governing) board policy or legislative changes.” 

Jonathan Thomas, chairman of CIRM governing board at far right. Art
Torres (center), co-vice chair and former state Democratic party chairman,
who would  play key role in dealing with lawmakers. Robert Klein is at the
 left in this 2011 meeting, Klein's last as chairman of the agency and the one
 in which Thomas was elected chairman. 

He continued,

“My goal is to strive to reach consensus on a course of action on the 23rd. However, if the board isn’t able to choose a course of action at this time we will continue the conversation and bring it up at future board meetings until we reach agreement.”

It is worth noting that Thomas did not mention the possibility of having to ask the people of California to amend the state constitution, which would require a statewide election. Opponents to change at the agency have used that possibility to discourage action. (See here and here.) An election would be costly, politically difficult and could open the door to additional unwelcome changes at the eight-year-old research enterprise.

Thomas' desire for a consensus among the 29 board members – instead of a simple majority – could be a stumbling block as the board becomes snarled internally, perhaps for months or more. The board normally meets only about once a month and has a full slate of regular business on those occasions. The agency will run out of money for new grants in less than four years, and action on the IOM recommendations seems a necessary prelude to winning continued financial support.

While four years would appear to an ample period of time, making the sort of changes the IOM recommends would require legislative action, which probably would take a minimum of a year. Timing is important as well. The current leaders in the state Senate and Assembly will be termed out in 2014. Starting all over with novice leadership, changes in key committee chairmanships and so forth would make the task even more difficult. Then there is the need to address strategies for continued financial support. Should the agency seek a new statewide bond measure (the current funding mechanism)? If so campaign committees need to be formed, electoral strategies planned and tested and tens of millions of dollars raised for campaign expenses. If private funds instead are to be raised to the tune of hundreds of millions of dollars(the agency spends about $300 million a year), such an effort would also require considerable time. To keep the funding pipeline full, all of this should be completed well before the money runs out in 2017.

Dilly-dallying this year in drawn-out, fruitless debate over the IOM proposals would be an unfortunate beginning should CIRM directors actually want to continue the existence of the organization.

In his blog item, Thomas sounded this final note.

“It’s likely the debate will be passionate – everyone involved in this work cares deeply about it – and there will undoubtedly be disagreements, but ultimately we all share the same goal, a desire to make sure that whatever we decide helps make the stem cell agency even stronger and more effective, and is in the best interests of the people of California.”

California Stem Cell Face-Off: CIRM Directors Wrestle with Tough IOM Recommendations

Two days next week at the posh Claremont Hotel in the Berkeley hills could settle the fate of California's $3 billion stem cell agency.

At 9 a.m. next Wednesday, the governing board of the state research effort will begin a critical, two-day public session. On the table will be the $700,000, blue-ribbon report from the prestigious Institute of Medicine (IOM). The study recommends sweeping changes in the structure and operations of the California Institute of Regenerative Medicine (CIRM), as the stem cell agency is formally known.

The IOM report alone poses major challenges for the agency. But the recommendations are freighted with even more significance. Below the surface lies the hard fact of CIRM's dwindling resources and possible demise. In less than four years – without either renewed public support or private contributions – the research effort will begin a shriveling, downward spiral.

Claremont Hotel

The IOM report places a special burden on the agency governing board. The board paid the IOM to evaluate its performance. In 2010, then CIRM Chairman Robert Klein trumpeted the value of an IOM study, saying it would serve as a springboard for a new, multibillion-dollar state bond measure for the agency(see here and here). Given the state's difficult financial condition – not to mention the position of potential private sector investors – winning approval of that kind of investment will be more than difficult. 

California's major newspapers already have editorially backed the IOM proposals. Indeed, if the directors choose to ignore the major IOM recommendations, they will hand opponents a devastating weapon, one that could be used to convince voters to reject any proposal for continued funding. The board would also give private investors more major reasons to say no to CIRM pitches for cash.

Under Klein's leadership, the 29-member board has rejected similar proposals for changes in the past. When the IOM presented the study to the board just last month, the reception was not much different. Several board members bristled. One influential board member, Sherry Lansing, chair of the University of California board of regents, said the directors' “hands are tied” because some of the recommendations might require a vote of the people. Her comments echoed similar statements from Klein in 2009, when he said board members would violate their oath of office if they supported recommendations for changes that he opposed.

The IOM discussion in December, however, was relatively brief and less than definitive. Klein has been off the board since June 2011, replaced by Los Angeles bond financier Jonathan Thomas, who is regarded as a welcome change by a number of board members.

Nonetheless, the recommendations of the IOM could mean that some members of the board would lose their seats; others would lose important roles in the grant-award process or within the agency itself. Conflict of interest rules would be tightened. In some ways, the board would lose power, which would be shifted to the president. The board would no longer vote on individual applications – only a slate recommended by reviewers. Applicants for CIRM awards would be directly affected, being barred from making the sort of direct and public appeals that clogged the CIRM board meetings last year. And that would be just the beginning.

Thomas, the CIRM chairman, is expected to make his recommendations for action on the report, although they have not yet been posted on the CIRM web site. Under what might be considered “normal” leadership, Thomas would be testing sentiment among board members via personal conversations and phone calls. However, in California that would be illegal – a violation of open meeting laws that bar what are called “serial meetings” at nearly all public agencies.

Thomas' task is not easy. Rounding up a majority vote for anything significant among 29 strong-minded individuals is not simple. But it is even more difficult when facing a board that has a tradition of consensus management and oversight.

The site of next week's meetings is interesting. The nearly 100-year-old, iconic Claremont hotel has a troubled financial history. It was up for sale for $80 million last spring but there were no takers. In the early 20th century, the property on which it is located was lost and won in a checkers game in Oakland, or so the story goes.

The stakes are also high for the California stem cell agency. Moves next week by directors could easily determine whether CIRM becomes nothing more than an interesting scientific footnote or establishes a path that will lead it to long-lasting leadership in regenerative medicine.

California Stem Cell Agency Launches Five-Year Push for Cures

The $3 billion California stem cell today officially embarked on a course that will mean closer ties to the biotech industry in hopes of fulfilling the campaign promises to voters to turn stem cells into cures.

On a unanimous voice vote, directors approved changes in the seven-year-old agency's strategic plan. The action will likely mean less money for some activities that enjoyed more cash in the past,  but directors put off action until at least late July.  The plan also sets the course for what may be the last years of life for the unprecedented state research program. Authorization to borrow more money (state bonds) for its grants will run out in about 2017.

During a brief discussion of the plan, which has been debated for some months, CIRM Director Jeff Sheehy noted that the agency has now entered "the realm of trade-offs."  Ellen Feigal, CIRM's senior vice president for research and development, told the board that the plan will require hard decisions and sharp focus on priorities. 

Among other things, for first time CIRM overtly set a goal of creating 20 programs that include outside investment that focus on products. Another five-year goal explicitly calls for financing at least 10 therapies in early-phase clinical trials, affecting at least five diseases. Overall, the plan seeks to achieve clinical proof-of-concept for stem cell therapies.

In contrast to the Proposition 71 campaign rhetoric, CIRM's strategic plan acknowledges that developing therapies takes a very long time, often decades.

Two scenarios were presented to the board for spending the agency's remaining $836 million for grants and loans. One would allocate $506 million for development research, $195 for translational research and $135 million for basic research, but nothing for training and "facilities/core resources."

The other scenario calls for $486 million for development research, $160 million for translational research, $105 for basic research, $60 million for training and $25 million for "facilities/core resources."

The first scenario would mean a $85 million cut in training and shared lab programs – cash that helps to finance researchers and that benefits the many institutions that have representation on the CIRM board. The board put off action on either scenario after CIRM President Alan Trounson said he wanted more time to prepare a complete analysis of the scenarios. 

The plan also calls for creation of a platform to enable grantees, disease foundations, venture capitalists and others to purse CIRM's mission when its state bond funding runs out. The possibility exists that another bond measure would be submitted to voters. But in either case, CIRM will need a solid record to attract support. 

Center for Genetics and Society: 'Wrong' to Ask for More Billions for Stem Cell Agency

IRVINE, Ca. – The Center for Genetics and Society today said it would "wrong" to ask the people of California for more money to continue financing stem cell research at state expense.

Marcy Darnovsky, associate executive director of the Berkeley, Ca., non-profit group, addressed a blue-ribbon Institute of Medicine panel evaluating the performance of the $3 billion California stem cell agency, which is financed by money borrowed by the state. The agency is expected to run out of cash in about five years.

Darnovsky said,

"In structural terms, a key question now is what will happen after CIRM’s public funding is exhausted. According to CIRM’s transition plan, another bond measure for additional public funding 'would be premature at this time,' but is still on the table. In our view, any additional public monies for CIRM would have to be justified in an analysis that emphasized health care priorities and health care disparities. While there is always tension between the allocation of public funds to scientific research and to other public goods, given our state’s economic decline and budgetary crisis, with so many critical social programs being gutted, we believe it would be simply wrong to ask Californians to set aside more money for one avenue of research, however important."

Representatives of the stem cell agency were present at today's hearing on the UC Irvine campus, but did not speak publicly at today's session. CIRM officials, however, have testified before the panel on two other days of public hearings. The agency is paying the IOM $700,000 to conduct the study. Its results and recommendations are expected to be published in November.

Darnovsky and others testifying at the morning session were critical of the agency's lack of accountability, built-in conflicts of interest and immunity from normal government oversight (see here and here).

Darnovsky said, "

The requirement for 70% super-majorities (to change the law regarding CIRM) means that there is still no meaningful oversight of CIRM by elected officials. The ICOC is still tainted by its built-in conflicts of interest. It still includes no representation of the public beyond disease advocates. Members of CIRM’s powerful Working Groups, including the one that reviews grant applications, are still not required to publicly disclose their individual financial interests.

"Given that hundreds of millions of dollars remain to be disbursed, and the widely mooted possibility that CIRM will develop a role that continues beyond the public funding stream that was allocated in 2004, now is the time to clarify and address these issues."

Here is the full text of Darnovsky's comments.
Center for Genetics and Society statement to IOM-CIRM panel, April 10 2012

Trounson Predicts -- 'Optimistically' -- Successful California Stem Cell Treatments in Five Years

Alan Trounson, president of the $3 billion California stem cell agency, says he is "optimistic" that some stem cell treatments developed in California will prove successful in humans in the next five years.

Trounson was quoted in The Sacramento Bee today in an opinion piece written by David Lesher, government affairs director of the Public Policy Institute of California. Lesher provided something of an overview of the agency, including pluses and minuses. He wrote,

"Those who speculate say that the most advanced stem cell treatments are still probably a decade away from becoming available to patients. And the cost to get them there will far exceed California's $3 billion investment."

But Lesher, a former political writer for the Los Angeles Times, also wrote,

"...(T)he president of the state's stem cell agency said he is 'optimistic' that at least a few California treatments will prove successful in humans in the next five years."

Lesher said,

"That may mean a genetically modified stem cell treatment to cure AIDS, (Trounson) said; it may mean a treatment that eliminates the need for some diabetics to monitor or inject insulin; there might be a treatment to restore eyesight to those suffering from a major cause of blindness.

"'These are the kind of things we need to get through,' he said. 'I hope that we have a number of them showing proof by 2015 or 2016. I'm optimistic. The caveat is that nothing is guaranteed.'"

The stem cell agency will run out of cash for new grants in 2017 and will go out of business shortly thereafter unless voters approve another multibillion dollar bond measure or it manages to secure private financing.

Lesher discussed the difficult financial environment for private financing of stem cell therapies and how it has changed since the the stem cell agency was created by voters seven years ago.

"The hope was that California's bond (financing for CIRM) would jump-start a biotech industry by building the laboratories and seeding early research to a point where private support would take over.

"But that point of commercial viability is a moving target as private investors have grown more risk averse and the regulatory path for such radical new therapies is unpredictable. So the biggest question today in the stem cell field is not whether the science will work someday. The big questions are how will we pay for it, how will regulators know when it's ready and when will it happen?"

Lesher said,

"The problem is that even the most advanced experiments in (CIRM's) translational portfolio are still a couple of years away from the same point in the regulatory pipeline where high cost and uncertainty forced Geron out of the field. And there is still no clear answer about how to resolve those same challenges, although the cost-benefit calculation will be different for other treatments."

Lesher concluded,

"Unlike high-speed rail, which continues to have strong support from the governor, the stakes surrounding California's stem cell investment have been largely invisible. That's too bad, because stem cell science is a much smaller investment for taxpayers with a greater possible return."

Our comment? In what CIRM Chairman Jonathan Thomas has declared as a "war" for public support, today's piece in The Bee was a bit of a victory. Although the article did mention difficult issues, it was generally upbeat about CIRM. The piece focused on the wonders of the science and bypassed many of the negatives about CIRM, including its built-in conflicts of interests and its reluctance to correct long-identified problems. Also absent was a discussion of how CIRM signed a $25 million loan agreement with Geron only three months before the company abandoned its clinical trial. That omission could be considered a PR plus for the agency. Overall, the folks at CIRM should be pleased by the article.

Stem Cell Researchers 'Uneasy" in California

The prestigious journal Nature today said that asking California voters for more billions for stem cell research in a few years "may strike residents as a luxury that they can ill afford."

The comment came in a piece by Erika Check Hayden dealing with the future of the California stem cell agency, which is expected to run out of money for new grants in about 2017. She wrote,

"Given that California is facing severe budget shortfalls, several billion dollars more for stem-cell science may strike residents as a luxury that they can ill afford. It may also prove difficult for CIRM’s supporters to point to any treatments that have emerged from the state’s investment. So far, the agency has funded only one clinical trial using embryonic stem cells, and that was halted by its sponsor, Geron of Menlo Park, California, last November.

"Yet the institute has spent just over $1 billion on new buildings and labs, basic research, training and translational research, often for projects that scientists say are crucial and would be difficult to get funded any other way. So the prospect of a future without CIRM is provoking unease. 'It would be a very different landscape if CIRM were not around,' says Howard Chang, a dermatologist and genome scientist at Stanford University in California."

Chang was a scheduled witness recently at a public meeting in California of the blue-ribbon Institute of Medicine panel examining the performance of the Golden State's $3 billion stem cell research effort. Chang is the recipient of $3.2 million in CIRM funding. Hayden wrote,

"Chang has a CIRM grant to examine epigenetics in human embryonic stem cells, and is part of another CIRM-funded team that is preparing a developmental regulatory protein for use as a regenerative therapy. Both projects would be difficult to continue without the agency, he says. Federal funding for research using human embryonic stem cells remains controversial, and could dry up altogether after the next presidential election (see Nature 481, 421–423; 2012). And neither of Chang’s other funders — the US National Institutes of Health (NIH) and the Howard Hughes Medical Institute in Chevy Chase, Maryland — supports his interdisciplinary translational work. Irina Conboy, a stem-cell engineer at the University of California, Berkeley, who draws half of her lab’s funding from CIRM, agrees that in supporting work that has specific clinical goals, the agency occupies a niche that will not easily be filled by basic-research funders. 'The NIH might say that the work does not have a strong theoretical component, so you’re not learning anything new,' she says."

Conboy was also a scheduled witness at the IOM hearing. She holds $2.2 million in CIRM grants.

Performance Review of California Stem Cell Agency Dominated by $418 Million Worth of Friendly Witnesses

The Institute of Medicine opens its inquiry in San Francisco next week into the performance of the $3 billion California stem cell agency with testimony from representatives of enterprises that have received $418 million from the agency. No independent witnesses are scheduled to appear.

The IOM is being paid $700,000 by the stem cell agency to conduct the study, which was authorized by the CIRM board in 2010, with the hope that the findings would bolster voter support for another multibillion dollar bond measure for the agency.

So far the IOM-CIRM panel has held one day of public hearings in Washington, D.C., only involving CIRM representatives. Next week's session will be one of two days of public hearings in California before the inquiry is concluded. Another one-day public session is scheduled for Washington. So far the IOM-CIRM panel has not publicly heard any independent analysis of CIRM operations.

Earlier this week, the California Stem Cell Report asked Harold Shapiro, chairman of the IOM-CIRM panel, whether the IOM actually expected to receive forthright assessments of CIRM from individuals linked to institutions that have received hundreds of millions of dollars from the agency.

Shapiro did not reply but referred the inquiry to a public relations person at the IOM, Christine Stencel. She said that next week's meeting is one of "several means" by which the panel will gather information. She pointed to a short note on the IOM website linking to survey forms for others who may be interested in communicating with the panel.

Eleven witnessesses are scheduled for next Tuesday's meeting. Five are CIRM employees or members of the CIRM governing board. The remaining six come from institutions that have received $418 million from CIRM: Stanford ($193 million), UC San Francisco ($115 million), UC Davis($62 million) and UC Berkeley ($48 million). Five of the witnesses have received grants directly from CIRM: Alice Tarantal of UC Davis($5 million), Howard Chang of Stanford ($3.2 million), Irina Conboy of UC Berkeley ($2.2 million), Helen Blau of Stanford ($1.4 million) and John Murnane of UC San Francisco ($1 million).

We asked Shapiro how the witnesses for next week were selected. Stencel replied,

"The list of presenters and topics you see on the agenda reflect information and insights that the committee considered useful at this point in its work."

We asked,

"Why weren't representatives from other well-informed California organizations invited, such as the Little Hoover Commission, which performed a lengthy study of CIRM, and the Center for Genetics and Society, which has followed CIRM since 2004.?  Are there any plans to seek them out for public comment?"

The IOM did not respond directly but made the general statement about using "several means" to gather information.

We also asked,

"Why is 50 percent of (next week's) meeting being held behind closed doors? Who is expected to testify? What will be the nature of the business to be discussed? CIRM is a public enterprise, engaged in spending $6 billion (including interest) of taxpayer funds. It would seem that almost nothing that it does should be  barred from public scrutiny."

Stencel replied,

"The closed portion of the meeting will be devoted to internal committee discussions; there will be no presentations. This is per the National Academies study process."

(The National Academies are the parent organization of the IOM.)

Two members and the study director of the IOM-CIRM panel also made an unannounced trip to California last year, visiting Stanford and UC San Francisco in addition to CIRM offices. The IOM did not respond directly to questions from the California Stem Cell Report about whether the trip was at the invitation of CIRM and whether the traveling members met with any representatives of institutions or groups that have not received CIRM funds. Stencel said the trip was undertaken to gain a "better understanding" of the task before the panel.

The text of the questions asked by the California Stem Cell Report and the IOM response can be found here.

Stem Cell Agency Shying Away From Another Multibillion-dollar Bond Proposal

The $3 billion California stem cell agency, which is expected to run out of cash in five years, is backing away from an attempt to win voter approval of another multibillion dollar bond measure to finance its research efforts.

The agency disclosed its new position in a document posted in connection with the meeting tomorrow of its governing board in San Diego. CIRM said,

"Although additional funding could be a possibility in the future, it would be premature even to consider another bond measure at this time. Instead, CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work."

The statement is a sharp departure from previous discussion of mounting a ballot campaign for a $4 billion to $5 billion bond measure on behalf of CIRM.

The only significant source of cash for the agency currently is the $3 billion in bonds approved by voters in 2004. Nearly half of that is committed. The latest financial report from CIRM shows its funding of research peaking in 2017-18.

During the last year or so, former CIRM Chairman Robert Klein has repeatedly discussed another bond measure and has even more recently expressed his desire to raise funds for a new electoral campaign. Klein resigned from his post last June. The CIRM board elected Jonathan Thomas, a Los Angeles bond financier, to replace Klein, who was the agency's first chairman and who led the 2004 ballot campaign.

In 2010, the CIRM board approved spending $700,000 for an Institute of Medicine study of CIRM with the expectation that its findings would enhance the likelihood of approval of more bond funding.

The IOM study is currently underway. The blue-ribbon panel is scheduled to hold a two-day public meeting in San Francisco Jan. 24-25 as part of its assessment of CIRM performance.

CIRM largely functions below the news media's radar, but talk of a new pitch for money has triggered negative commentary. Last month, the San Jose Mercury News said in an editorial that the agency should close its doors when its cash runs out because another bond measure would siphon off much-needed money for education and other critical services already "starved" by state budget cuts.

Backing away from another bond measure could benefit CIRM by helping to remove the likelihood that its actions will be judged in the context of an electoral campaign. But the action also raises the possibility that some of CIRM's best employees may leave for better prospects given that they may not have much of a future at an agency that would appear to be going out of business – at least at its current robust level.

The CIRM document dealing with the bond measure is dubbed a "transition plan" and is required by state law.

Instead of seeking to borrow more billions, the document said,

"CIRM should focus its efforts on creating a platform that enables others to carry on CIRM’s work. Through its funding of state of the art research facilities, collaborative funding agreements, and industry engagement, CIRM has already made progress in creating this platform."

The document also raised the possibility of creation of a nonprofit organization to carry on CIRM's stem cell research, a proposal that has floated quietly for some years. Such an effort could involve raising funds from the biotech industry, which CIRM is currently trying to engage in a more friendly way.

At the top of CIRM's list of transition plan activities is creation -- both nationally and internationally -- of "Alpha Stem Cell Clinics" for delivery of therapies to patients. The clinics also would foster clinical trials and evaluate cell therapies. Additionally included are efforts to drive "follow-on funding" for CIRM projects and strengthened efforts to support industry.

Directors could alter the CIRM transition plan at their meeting tomorrow. But it was placed on the agenda by Chairman Thomas and is unlikely to see major revisions.

San Jose Merc to California Stem Cell Agency: Time to Bow Out

The $3 billion California stem cell agency should shut its doors when its cash runs out in about six years and turn over development of stem cell therapies to industry and academe, the San Jose Mercury News said in an editorial on Saturday.

The piece in the leading newspaper in California's Silicon Valley was headlined, "Stem Cell Institute Should Take a Bow (Out)."

The newspaper wrote,

"This state is in financial crisis with no full recovery in sight. Bankrolling the next phase of research would come at the expense of other critical state services, including public education, that are state government's core mission and already are starved by budget cuts. It would be a mistake to pile more debt onto the state's already heavy bond obligations, which are paid off from the same general fund that pays for schools and other services. Medical research is important, but it is not at the heart of state government's mission. Bond measures now need to deal with water supplies and other looming crises."

The editorial said CIRM has provided a "strong foundation from which universities and companies can move toward cures."

But the newspaper concluded,

"Cures remain elusive -- there is never a guarantee with scientific research -- but the 10-year start voters approved was meant to be just that. The promise of stem cell treatments now must be kept alive with funding from industry, academic institutions and private foundations and philanthropists."

The editorial comes as the seven-year-old agency is driving to turn research into therapies that can actually be used in treatments. At the same time, CIRM is considering asking California voters to approve another multibillion bond measure in the next few years, a proposal that seems to be fresh news to many in the media.

The San Jose newspaper covered the stem cell agency with some detail in its first year of operation. In the last few years, however, the paper's coverage has been all but non-existent, like most of the news media in California.

Earlier this month, the paper published an overview of the agency, which highlighted the discussions by former CIRM Chairman Bob Klein about another bond issue, along with the fact that the cures promised by the campaign of 2004 have not materialized. The proposed bond issue is old news for most persons who have followed CIRM; the plan has been around publicly for more than a year. But the call for more cash comes a surprise to many of in the media. And to the public. So it is likely to pop up again as other news outlets re-visit the agency from time to time.

The presence of another electoral campaign also imposes a different sort of burden on CIRM – something quite removed from such matters as the basic biology of stem cells. It means that the stem cell agency's endeavors are being evaluated in a political context, which involves such questions as whether its actions are designed to generate the millions in campaign contributions necessary to win a statewide election or whether it is neglecting valuable research for something that will instead generate a high profile result for the benefit of the campaign but not add much to the science.

It is all part of tactics and strategy involved in the "communications war" that CIRM Chairman Jonathan Thomas discussed with CIRM board members last June in his bid to win election to his post.

ACT and CIRM: Fresh Life in a Troubled California Stem Cell Courtship?

Advanced Cell Technology, which has unsuccessfully sought funding several times from the $3 billion California stem cell agency, drew some attention today in a piece in a Massachusetts newspaper.

The Worcester Telegram took a look at the firm, headquartered in Santa Monica, Ca., with labs in Marlboro, Mass., in the wake of Geron's departure from hESC research. The move left ACT as the only firm in the country with an hESC trial and perhaps with a better shot at CIRM funding.

Reporter Lisa Eckelbecker wrote,

"Advanced Cell, publicly traded since 2005, has spent years developing its technologies. The company brings in little revenue and has an accumulated deficit of $180.9 million. About 1.6 billion shares of Advanced Cell common stock is outstanding, a result of numerous financings over the years. It trades for about 10 cents a share on the Over-the-Counter Bulletin Board, an electronic exchange for small companies. No analysts from major Wall Street banks report on the company.

"The company's treatment for Stargardt's macular dystrophy and dry age-related macular degeneration — the treatment that required (a) mountain of paperwork before the FDA — first went into the eyes of patients in July in Los Angeles. The retinal pigment epithelial cells, generated from embryonic stem cells, were developed to slow the progression of the eye disorders, which can lead to blindness."

ACT moved its headquarters to California following the passage of Prop. 71 in 2004, the ballot initiative that created the California stem cell agency. The company said at the time it expected to "gain significant momentum by being able to take advantage of a favorable environment for funding."

ACT initially landed in Alameda, Ca., but has since moved to Southern California. Its official opening in 2006 in Alameda was attended by the state treasurer and at least one CIRM official, according to the company. The firm has never secured funding from the stem cell agency, which does not release the names of rejected applicants. However, the California Stem Cell Report carried an item in 2008 that pointed out that a researcher for ACT complained publicly about a reviewer's conflict of interest in connection with an ACT application(see here and here). At the time, Robert Klein, then CIRM chairman, brushed off the complaint. The journal Nature has also reported that ACT has applied unsuccessfully several times for CIRM awards.

It is a fair bet that ACT was an initial applicant in the round that provided funding to Geron last spring. However, by the time Geron's application went to the full CIRM board, the other applicants had withdrawn – the first time such an event had occurred at CIRM.

Since Geron pulled out of the hESC business last month, it is likely that ACT and CIRM have opened fresh discussions, given their mutual interest in producing a stem cell therapy. CIRM also has a new chairman who is familiar with ACT. After Geron was awarded its $25 million loan from CIRM last May, the agency's board elected as chairman a Los Angeles bond financier, Jonathan Thomas, who led an early round of financing for ACT in 2000. Thomas last summer sold his remaining 17,046 shares in ACT for $3,239. Thomas said he had a "significant loss" on the sale but did not disclose the amount.

Geron's flight from hESC and ACT's perserverance come as the stem cell agency is pushing aggressively to drive research into the clinic. Plus CIRM needs tangible results that voters can understand if CIRM is win ballot-box approval for continued funding in the next few years. The agency will run out of cash in about 2017 and is considering mounting a campaign for another multibillion bond issue.

New Multibillion Dollar Stem Cell Bond Measure Wins Endorsement with a Caveat

A blogger on the web site of Los Angeles television station KNBC today supported a new multibillion bond measure for the California stem cell agency but with an interesting qualification.

Joe Mathews, author and a senior fellow at the New America Foundation, said the new bonds should be backed by a tax on the people and companies involved in the business of health care. He wrote,

"New stem cell moneys can't come out of funds that would otherwise go to other programs."

Mathews said voters "probably" shouldn't approve another multibillion dollar bond measure for CIRM that is paid back through the state's general fund. He wrote, however,

"(T)hat doesn't necessarily mean there shouldn't be another stem cell bond. California's major universities have invested in stem cell research, with help from the agency.

"Major researchers have relocated to the state. And the unknown nature of stem cell research's promise, while frustrating efforts to justify the research dollar for dollar, argues for doing more to learn more.

"What the state budget picture does require is that any stem cell bond should have a clear funding mechanism -- a specific tax or new revenue source (some sort of levy on companies and people involved in the business of health care) -- that would be more than enough to pay back any bond."

Mathews is co-author of "California Crackup: How Reform Broke the Golden State and How We Can Fix It," which declares that the initiative process is one of major fault points in California government. The initiative was used to create the $3 billion stem cell agency in 2004, making it immune from normal state government accountability and locking in funding that cannot be touched by the legislature or government despite any other financial needs of the state.

Klein, Moral Mandates and Stem Cells

Just a few days ago, the California Stem Cell Report carried an item about the state's stem cell agency and its supporters' mantra that the agency has a mandate from voters albeit one that is seven years old.

We mentioned that Robert Klein, the former chairman of the agency and head of the 2004 ballot campaign that launched CIRM, is one of those fond of citing voter mandates with great regularity.

Indeed, Klein found shelter again this week under a voter mandate, but this time it was a moral one.

Klein popped up in a San Jose Mercury story about the status of the stem cell agency. Writer Steve Johnson said that Klein declared that he quit as chairman last June in part because he wants to raise money for a campaign for another multibillion bond measure for CIRM. Johnson quoted Klein as saying,

"It would be a huge failing in meeting our moral mandate" to let CIRM die. "We can't afford to break the momentum."

As we noted on Dec. 6, mandates come and go, as another multibillion California bond program, high speed rail, has discovered.

San Jose Mercury News: California Stem Cell Agency Eyeing More Bonds but Has No Treatments

In an overview of the $3 billion California stem cell agency, the San Jose Mercury News says that CIRM "still has no treatments on the market and is at a critical juncture that could determine how much longer it stays in operation. "

The story is the second significant piece about CIRM this week in a major California newspaper, which has not received much coverage in the mainstream media in the state in the last year or so. The Los Angeles Times earlier this week carried a column that raised questions about the "Geron fiasco" involving CIRM and the conduct of the agency's business.

The San Jose article yesterday by Steve Johnson said that voters "may not be as enthusiastic" about providing several billion dollars more to finance the agency as they were when they created it seven years ago.

The newspaper, located in the heart of California's Silicon Valley, quoted John Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., as saying,

"I think it's crazy. The state's economy is in a far different position now. We're not even able to provide adequate funding for education."

Johnson also reported that former CIRM Chairman Robert Klein, who led the 2004 Prop. 71 campaign, is raising or intends to raise funds for another bond issue, perhaps in 2014. The agency will run out of cash in about 2017, according to its projections.

The article noted that CIRM has awarded only $83.4 million to 15 businesses, which are the key to pushing research into the clinic,  out of the $1.3 billion it has handed out. Johnson wrote,

"Many businesses have been deterred from even trying to make stem-cell treatments because of how long it might take.

"'It's a challenge,' said Rodney Young, chief financial officer at Newark-based StemCells, which hopes early next year to obtain a $20 million institute grant to determine if a type of adult stem cell can slow the loss of cognitive function in Alzheimer's patients. 'It's an expensive, uncertain and long process.'"

Johnson additionally noted that CIRM has received criticism for the high salaries it pays its top executives and for conflicts of interests.

Los Angeles Times: 'Geron Fiasco' Poses Questions About California Stem Cell Agency

The Los Angeles Times, California's largest circulation newspaper with more than 900,000 subscribers, today said the "Geron fiasco" raises questions about the conduct of business at the California stem cell agency and whether it "does a disservice to patients and taxpayers."

The comments came in a column by Pulitzer Prize-winning journalist and author Michael Hiltzik, who wrote about Geron's abandonment of its hESC trial only five months after the firm was awarded a $25 million loan by the stem cell agency. Hiltzik said,

"So we're talking at least about months of wasted effort by CIRM and Geron's researchers, crushing disappointment for those patients and conceivably a major setback for stem cell science generally. (CIRM Chairman Jonathan) Thomas observes that Geron said it made its decision strictly on financial grounds, not because of scientific reversals. But for an R&D company financial considerations always encompass scientific judgments, and Geron plainly concluded that the prospect for profits from stem cell therapies was receding.

"The Geron fiasco underscores the old questions, and raises new ones, about what CIRM is supposed to accomplish, how it does business and whether its addiction to hype does a disservice to patients and taxpayers."

Hiltzik's column contained brief remarks from Thomas. The columnist wrote,

"'There are going to be fits and starts,' its chairman, Jonathan Thomas, told me last week. Even so, he maintained, 'we remain unwavering in our commitment to pursuing the science.'"

Hiltzik has followed CIRM since the 2004 ballot initiative campaign that created the $3 billion enterprise. The effort was headed by real estate investment banker Robert Klein, who later served as CIRM's chairman for seven years. Hiltzik wrote,

"CIRM loves to compare itself to the federal government's biomedical research agency, the National Institutes of Health, but the two bodies are very different. The responsibilities of NIH are broad enough for it to make disinterested judgments about programs and scientific approaches. CIRM, however, was designed from the start (by Klein, who oversaw the drafting of Proposition 71) to focus on a very narrow field of biomedical science — embryonic stem cell research — and to promote that research in California as a sort of economic development tool.

"These two goals have always been ethically and scientifically incompatible, and the Geron case points to why."

Hiltzik said evidence exists to show that CIRM "downplayed legitimate questions about the state of Geron's science and the design of the clinical trial" in its efforts to fulfill the excessive promises of the electoral campaign. The issues, he said, included over-promising results, questions by other researchers about the trial and whether a spinal cord injury was the best subject for the first tests of stem cell therapies on humans.

Hiltzik continued,

"None of these issues were aired publicly in the run-up to the vote, because CIRM didn't disclose in advance that Geron was the loan applicant. Nor did it disclose that its own scientific review panel had awarded the Geron trial a scientific score of only 66 out of 100; that fact, along with other details of the board's consideration of the Geron loan, was pried out of CIRM later by David Jensen, the tireless proprietor of the indispensable California Stem Cell Report.

"CIRM told Jensen that although it customarily discloses its reviewers' scientific scoring of funding proposals, it didn't in this case because it was using 'new criteria' and thus the public might not find the result 'meaningful.' Call me a cynic, but I'd bet that if the score were, say, 90 out of 100, CIRM would have shouted it from the rooftops, rather than pleading that Californians were too dumb to understand what the number meant."

Hiltzik concluded,

"Another problem illuminated by the Geron case is that CIRM remains infected by the hype virus. Only a week after Geron parachuted out of the stem cell business, Thomas issued a statement bemoaning the public impression that CIRM isn't making any progress toward therapies. He declared: 'CIRM is turning stem cells into cures.'

"Well, no it isn't, not yet. Geron's now-halted project was the most advanced human clinical trial in CIRM's portfolio; yet it was at an extremely early stage, involved all of five human subjects and might still have been years away from showing that a cure was even possible. CIRM needs to take a good look at whether it pushed too hard for the Geron loan and overplayed the significance of the trial; otherwise its path toward building credibility with the public will only get longer."

The California Stem Cell Report has asked CIRM Chairman Thomas if he would like to respond in more detail to the Los Angeles Times column, with a commitment to carry his remarks verbatim.