'Critical Stage' for $3 Billion California Stem Cell Effort and its Search for More Cash

California's $3 billion stem cell research program later this month is expected to unveil detailed plans for extending its life beyond the middle of 2020 in hopes of avoiding a lingering death.

The latest proposals, which are not yet public, are scheduled to be discussed Nov. 27. Possibilities range from another multi-billion dollar bond measure to private fundraising to possible merger with some sort of private entity.  

The stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM), projects its cash for new awards will run out in about 2 1/2 years. At that point, unless more money is forthcoming, CIRM will only be overseeing the dwindling number of awards whose terms extend beyond June of 2020.

The agency's fate was dictated by Proposition 71, which created CIRM in 2004. It also provided $3 billion in state bond funding, which flows directly to CIRM without oversight by the governor or the legislature. No additional, significant resources were contained in the ballot initiative.

CIRM's future has been an occasional topic for its board for some time. But the issue has taken on more urgency this year. At a meeting in September of a newly formed Transition Subcommittee of the governing board, CIRM Chairman Jonathan Thomas said in what may have been an understatement,

"CIRM, as we know, is at a critical stage of its mission here." 

The meeting on Nov. 27 will additionally involve the board's Science Subcommittee. What emerges from the session will go to the full, 29-member board in December for ratification.

Options in September included a multi-billion dollar bond ballot measure in 2020 and a possible merger, which was described as something of a last resort. Whatever path is chosen, it likely would lead to changes in the agency, which has been criticized for conflict of interest issues and its dual executive arrangement, among other matters.

The agency has awarded $2.3 billion in 919 grants during its 13-year history. About 90 percent of the awards has gone to institutions with links to members of the governing board, past and present, according to calculations by the California Stem Cell Report.

So far the agency has not fulfilled expectations of voters that it would generate a widely available therapy. Something may emerge in the next couple of years from the 38 clinical trials currently backed by the agency. (Forty-three have been funded but five were terminated.) The trials, which can take years, are the last stage before a therapy is approved by the Food and Drug Administration for widespread use. CIRM plans to add more trials in the next couple of years.

This month's meeting will be based at CIRM's Oakland headquarters with teleconference locations elsewhere in the state where the public can take part. It is scheduled to begin at 1 p.m. PST and run until 4 p.m.

The California Stem Cell Report will provide full coverage of the meeting that day with advance information as it is posted on the CIRM web site.

(Here is a link to the transcript of the September meeting. Here is a link to Thomas' slide presentation.)

Asterias Biotherapeutics: Sizzling Superlatives on California Stem Cell Trial for Spinal Cord Injuries

A California stem cell trial backed with $21 million in state cash has generated "super, super-exciting" results involving patients who were paralyzed as the result of  severe spinal cord injuries.

A story today by Erin Allday in the San Francisco Chronicle said,

"Four out of six paralyzed patients who had 10 million stem cells transplanted into their spinal cords have shown striking improvement a year after treatment, including increased ability to move their hands and arms and to perform basic functions like feeding and bathing themselves, according to research results being released Monday. 

"All six patients in the early-stage clinical trial, conducted by Fremont’s Asterias Biotherapeutics, reported at least some recovery after the stem cell transplant. The trial is among the first to use embryonic stem cells in human subjects. 

"It’s too soon to know for sure that the stem cells were solely responsible for the patients’ improvement. The patients could have experienced a spontaneous recovery, which is not unheard of in spinal cord injury victims, or their improvement could be the result of intense rehabilitation. 

"But compared to a large group of people with similar injuries, the results among patients treated with stem cells were remarkable, said doctors and scientists involved with research.

Allday also wrote,

“Scientifically, I have to say we don’t know for sure if it’s the stem cells. But I’ve been treating these kinds of patients for 30 years, and I’ve never seen anything like this before,” said Dr. Richard Fessler, lead investigator of the Asterias trial and a professor in the department of neurosurgery at Rush University Medical Center in Chicago."

The Chronicle story continued,

"'The bottom line is super, super exciting. Well beyond anything I thought we could have achieved at this point,' said Dr. Edward Wirth, chief medical officer with Asterias."

The story was good news for the California Institute for Regenerative Medicine (CIRM), as the $3 billion, state stem cell agency is formally known and which has pumped the $21 million into the work. However, the bad news was that the agency's support of the research was not mentioned until the last paragraph of the Chronicle story. Most readers are not likely to get that far.

CIRM has backed Asterias with $14.3 million. The agency also funded the research with $6.4 million to Geron Corp.,which abandoned the trial for financial reasons. Asterias later acquired the research from Geron.

The agency has had a tough time getting its successes into the mainstream media for a number of years. But its story is now more important for the agency and will be for the new next three years. It is scheduled to run out of money for new awards in mid 2020. It is currently examining funding options including the possibility of asking voters for another multi-billion dollar bond issue. The nearly 13-year-old effort has not yet fulfilled voter expectations of development of a widely available therapy. Without something dramatic to show voters, a bond issue is likely to have heavy going.

The agency also put out a news release on the developments as did Asterias. However, a check with Google at 4 p.m. Monday showed that no other newspapers or other major mainstream outlets have picked up the story yet.

The news seemed to benefit the price of Asterias stock. It rose nearly 6 percent today, closing at $3.20. Its 52-week high is $5.80 and its 52-week low is $2.83.super

The Demise of California's Stem Cell Agency: Gone in Three Years or Perhaps Some Other Date?

The $3 billion California stem cell agency goes out of business in less than three years: True or false?

For those of you seeking certainty, the "definite" answer is maybe. The agency has been saying for a couple of years now that it will run out of funds for new awards by roughly the middle of 2020. However, prior to that estimate, the death knell for the research program was forecast for much earlier. In fact, it would have come this year, 2017.

The difference is the result of different projections at different times by different leadership of the California Institute for Regenerative Medicine (CIRM), as the Oakland-based agency is formally known. When Alan Trounson, an internationally known scientist, was president of CIRM, it produced  the 2017 figure. When Randy Mills, a longtime biotech business executive, took over three years ago, he redid the estimate and came up with 2020.

The difference is based on assumptions. And they involve the "burn rate" of CIRM's cash. With the support of the board, Mills reduced the rate at which money would be awarded thus extending its effective life.

Steve Juelsgaard, Iowa State photo

CIRM board member Steve Juelsgaard, a former top executive with Genentech, in June briefly highlighted the vagaries of CIRM's possible demise. According to the transcript of the board meeting, he told CIRM directors:

"So there are ultimately three possibilities, right? The one that's most looming is the ending of current funding at some point in the future. Right now we're targeting 2020..... However, we're the ones who can determine when that funding will end. If we think it's better to run past 2020 to give ourselves more runway, then we should formulate a plan that would allow us to go to 2021 or even a little bit beyond that to see what happens. So nothing is cast in stone yet (concerning) exactly when we're going to end up with our funding.

"The second one would be the opportunity to have a new bond measure passed, let's say, in 2020.  So what's the plan? If that were to happen, then the third one is going back to the old private-public partner approach which, as I understand it, is still on the table.

"So, in any event, I think what we need are side-by-side plans that look at all of those, that as time goes on and it becomes clear which of those is likely to occur, we can just put it into play. The one that's most likely to be put into play is the one that ends the organization. And then if one of the others comes in after the fact, we can then plug it in and continue on."

Later this week, the California Stem Cell Report will look at a new governing board committee that is examining the various end-of-life, CIRM scenarios. As an aside, during the 2004 ballot campaign that created CIRM, it was widely and erroneously believed that CIRM would have only a 10-year life. The 10-year figure dealt with the agency's bonding authority from the date when bonds were first issued.

Plans Scrubbed for a 2018 Bond Measure for California Stem Cell Research

BURLINGAME, Ca. -- Plans to ask California voters in 2018 to approve a $5 billion bond issue to finance the California stem cell agency have been shelved,  a director of the agency said today.

Jeff Sheehy, a San Francisco county supervisor, said that the key backer of the proposal had informed him that no bond measure would be offered to voters before 2020, presumably at the presidential general election.

At a meeting of stem agency directors, Sheehy said this morning that Bob Klein, who led the 2004 ballot campaign that created the agency, had told him by telephone that a 2018 bond measure was now off the table.

Sheehy did not go into reasons for the delaying the bond measure. However, conventional political wisdom holds that bond measures have a better chance of approval during a general election that attracts a larger voter turnout.

J.T. Thomas, chairman of the agency's board, said he was forming a transition committee to make plans for various alternatives, including shutting down the agency in 2020.  The California Institute for Regenerative (CIRM), as the agency is formally known, currently estimates that it will run out of cash for new awards in just three years.

Other alternatives to be examined include funding from a new bond measure and some sort of private-public partnership.

Guest Posting: "Stem Cell Options Should be on the Table"

(Editor's note: The following is a guest posting from Joseph Rodota and Bernard Munos, both of whom have been active in California policy matters for some time. More biographical information can be found at the end of the item. The California Stem Cell Report welcomes diverse, well-considered views on California stem cell issues. If you have something that you think should see the light of day, please send it to djensen@californiastemcellreport.com.)

By Joseph Rodota and Bernard Munos

The sponsors of Proposition 71, the 2004 initiative that provided $3 billion in bonds to support stem-cell research, are readying a proposal to keep the agency alive after the last of these funds have been given out. According to recent news reports, a new $5 billion bond could be on the California ballot as early as November 2018.

Researchers supported by the California Institute for Regenerative Medicine (CIRM) have published hundreds of academic articles, but placed fewer than 30 drugs in clinical trials.

Even if all of these clinical trials resulted in drug candidates, they would still come up against the so-called “Valley of Death”—the well-documented shortage of funding for early-stage translational research.

California needs to move regenerative medicine from an academic timeline to a business timeline. The skills needed to turn an academic discovery into a commercial product are very different from the skills needed to be a successful academic scientist.

We proposed an alternative to continuing the current approach -- a state bond with three distinctive features:

A Focus on Entrepreneurs: Funds would be available only to companies, not academics (who would still be able to tap into billions in NIH funding for stem cell research);

A Focus on California: Only companies with a headquarters and a majority of employees in California, the nation’s center of overall innovation, or willing to relocate here; and

A Focus on Breakthrough Medicine: Only companies working on projects that have the potential to greatly impact patient health would qualify.

The University of California is well-qualified to administer this bond and report on its operations to the Legislature and the Governor, without the need for the cumbersome and controversial governance structure put in place by Proposition 71.

In exchange for the funds they receive, companies would tender to the University of California shares of their common stock, with an estimated value as determined by the most recent outside valuation or price set by investors. These shares would become part of the UC endowment -- and the University of California be free to sell or leverage these shares, or acquire additional shares, as it sees fit.

CIRM has over-invested in academic research, and under-invested in translating that research into therapies that cure diseases and prolong heathy lives. California needs to right that balance.

(Joe Rodota served as Cabinet Secretary to former California Governor Pete Wilson and director of policy for Arnold Schwarzenegger’s 2003 recall campaign. Munos is a senior fellow with FasterCures and the founder of the Innothink Center for Research in Biomedical Innovation.).

Here is a summary of the bond proposal.

SUMMARY -- California Next Generation Cures Bond -- June 2017 uploaded by DavidJensen on Scribd

California's Alpha Stem Cell Clinics: A 21-Video Overview of the $40 Million Effort

The great mysteries and not-so-great mysteries of the stem cells and their likely applications are the subject of a host of videos drawn from a day-long meeting this month at the City of Hope in California.

The occasion for presentation of the clips on You Tube was a symposium on California's Alpha Clinic network, which is scheduled to expand from three to five sites this year. That will boost the state investment in the network to $40 million.

The March 23 session included discussion of the results of some of the research at the sites -- City of Hope, UC San Diego and UCLA/UC Irvine. Patients spoke as well, and there were discussions of the economic barriers involving commercialization of stem cell therapies.

Of particular interest was a nine-minute look at "stem cell therapy value and reimbursement considerations" by Jennifer Malin of United Healthcare.  That video is at the top of this item.

The Alpha network was initiated by California's $3 billion stem cell agency. Geoff Lomax, the agency's senior officer for strategic initiatives, presented an overview of the program. Below is a video of Bob Klein, the agency's former chairman, in which he indicates he will be backing a $5 billion bond measure to keep the agency going beyond 2020, when its funds run out.

Twenty-one videos are available. Here is a link to the agenda, which is useful as a guide to pick videos that are more likely to be relevant to a viewer's particular interests.

State Lawmaker Aims to End California Stem Cell Program, Calls It a 'Boondoggle'

State Sen. John Moorlach in video from his office

A California legislator has launched an effort to terminate the $3 billion California stem cell agency, which is already set to go out of business in about three years.

Republican state Sen. John Moorlach of Costa Mesa said in a video,

"It's time to shut this down....We as taxpayers need some protection. We need to stop the boondoggle."

Moorlach has authored a proposed constitutional amendment that has been referred to the Senate Health Committee. No hearing date has been set. The measure would strip from the state constitution the language that created the agency in 2004.

The proposal, SCA7, requires a two-thirds vote of both houses of the legislature and approval by a vote of the people. Given the Democratic dominance of the legislature, that makes the chances of enactment of SCA7 unlikely.

Nonetheless, Moorlach's effort reflects the sentiments of a certain segment of the public. It also provides ammunition for those seeking to fund the agency with another $5 billion, which would additionally be placed before voters, probably in November 2018.  It is useful for campaigns for such measures to be able to point to what they consider threats to science and medical progress.

Backers of a $5 billion bond measure are proposing it because the agency is slated to run out of cash for new research awards by June 2020.

Moorlach's office produced a short statement in support of elimination of the California Institute for Regenerative Medicine or CIRM as the agency is formally known. It said,

"California voters approved a ten year stem cell program that they thought would produce widespread cures and save thousands of lives. They were also promised revenue-producing intellectual property that would help the state financially. These remain empty promises.

"More than thirteen years after its passage, around $2 billion in funds have been dispersed and $1.2 billion has been spent on servicing the principal and interest of the debt . With a $1.6 billion dollar budget deficit and crumbling infrastructure, we need to stop the issuance of bonds on an ineffective and unaccountable agency. Scarce taxpayer funds could be of better use elsewhere."

Asked for a comment on the legislation, an agency spokesman, Kevin McCormack, said,

"We are aware of the bill and are monitoring it." 

$700,000 Blue-ribbon Study of CIRM All But Finished

The $700,000 study of the $3 billion California stem cell agency is nearly concluded and is expected to be released sometime in November.

A draft of the report has been sent out for “peer review” and no additional public meetings are scheduled, according to a spokeswoman for the Institute of Medicine(IOM), which is conducting the study. The IOM did not respond to questions from the California Stem Cell Report about the number of peer reviewers or how they were selected.

The study began last year under a contract with the stem cell agency, which commissioned the effort, in part, because agency directors hoped the findings by the blue-ribbon panel would bolster efforts to win voter approval of another multi-billion dollar state bond issue. More recently the agency has explored the possibility of private financing to continue operations.

The agency is expected to run out of funds for new awards in 2017. It currently has something in the neighborhood of $700 million for awards that is not already committed in one fashion or another.

Christine Stencel, senior media relations officer for the IOM, said in an email,

“There will be no further information-gathering meetings. The committee members have finished drafting their report and it is now undergoing peer review. Reviewers are anonymous to study staff and committee members; they will be listed in the front matter of the report when it’s finished and released.”

She said the stem cell agency will not be given an opportunity to comment further. Stencel said,

“Sponsors are not treated as peer reviewers; that is, they’re not afforded an opportunity to comment on IOM draft reports prior to public release. IOM is aiming for a public release in November (the exact time frame will hinge on the duration of the peer review, which is influenced by people’s schedules and adherence to deadlines). IOM is looking at options for how best to hold this release, whether there will be an event of some sort. Once plans are set, they’ll be noted on the project web pages and IOM will alert the various stakeholders and interested parties of the plans. The study is moving along and we’re looking forward to the report’s debut in the not too distant future.”

Geron Loan Draws Media Attention to CIRM

The state of California's first-ever venture into a clinical trial involving human embryonic stem cells garnered more than the usual news coverage last week for the Golden State's $3 billion stem cell research effort.

At least more than usual for the stem cell agency, which has received modest attention in the mainstream media in recent years.

The $25 million loan to Geron Inc. of Menlo Park, Ca., drew articles in newspapers ranging from the Los Angeles Times to the San Francisco Business Times. However, the story was ignored by the San Francisco Chronicle, the San Jose Mercury News and The Sacramento Bee, based on our searches. That despite the fact that the circulation areas of the San Francisco and San Jose papers include the headquarters of both Geron and the California stem cell agency.

The lack of coverage by those papers undoubtedly is a reflection of the current overtaxed nature of the newspaper business along with the difficulty of peddling stem cell research stories to reporters and editors.

Keith Darce of the San Diego Union-Tribune had most developed story that we saw. It included comments from another stem cell company and termed the award "historic." Darce also pointed out that the loan is part of CIRM's effort to help stem cell companies through what is known as a financial valley of death – a period in which it is difficult to find conventional financing.

Eryn Brown at the Los Angeles Times, the state's largest newspaper and which has paid scant attention to CIRM, wrote,

"John M. Simpson, a consumer advocate with Consumer Watchdog in Santa Monica, Calif., said that making a loan to support a clinical trial made sense.  While his group has worried in the past about awards becoming 'boondoggles,' he said in this case Geron's trial was vetted carefully and the company met the requirements needed for funding. 'It could provide cures.  That's what everyone wants,' he said. 'I'm watching it with interest.'" 

CIRM's press release quoted outgoing agency Chairman Robert Klein as describing the state's investment as a "landmark step." But he cautioned that severe setbacks could be encountered. He said,

"We need to be prepared to stand by the heroic patients and the companies as they face these challenges and solve the problems that stand in the way of the recovery of patients from paralysis."

Over the last year, Klein has talked up another bond issue for CIRM that could total as much as $5 billion. CIRM operates on borrowed money (state bonds), which doubles the real cost of all its activities because of the interest expense.

To win voter approval of a new bond issue will require concrete results, such as those envisioned in the Geron trial, to justify continued state support of stem cell research.

Geron's three-year clinical trial is aimed at assessing the safety of its treatment. Any regular use of the therapy is probably a decade or more away because of the need to test its efficacy and to clear regulatory hurdles. Geron hopes to enroll 10 patients in its trial. The firm picked up its second in Chicago, according to a report this week.

Here are links to more stories, some of which incorrectly described the award as a grant, along with links to press releases on the state loan to Geron: Geron's press release, CIRM's press release, CaliforniaHealthline, Science magazine, Nature, myfoxla.com(two Los Angeles TV stations), xconomy and Fierce Biotech,

Bee Readers' Commentary on CIRM Not Warm and Fuzzy

As of late Sunday afternoon, 25 readers of The Sacramento Bee had filed comments on the newspaper's Web site dealing with the California stem cell agency, ranging from violent opposition to mild disgust with the research effort.

The readers were reacting to two pieces on the front page of the Bee's Sunday Forum section dealing with the agency – one by yours truly and one by Larry Goldstein of UC San Diego. The number of comments was quite modest but provides some inkling of the public perception problem facing CIRM. One good sign for CIRM is that the number of comments was small. That can be interpreted to mean that the public doesn't know much about the agency or simply doesn't care, which is better than vehement opposition if CIRM is successful in placing another multibillion dollar bond measure on the ballot. Keep in mind when reading the comments below that those who hold the strongest opinions are the most likely to make public comments. Those in mild support of CIRM are not likely to make the effort.

Here is a sample of the comments:

From "John_Toradze:"

“I am a scientist, one of those rare ones who is also an entrepreneur. And, I'm sorry, but Dr Goldstein is simply not competent to discuss whether California is going to profit by its stem cell investments. Professors learn to spend money in a system that is disconnected from applications. They never learn how money is made in that system. In the grants world, money grows on trees, and it falls into the laps of people who "write good" and have buddies who like them. Peer review committees are notoriously incestuous (at best). Further, science is (and should be) disconnected from profit. Science is about finding out how things work.

“Here's the cold water reality. Currently, there are two clinical trials for stem cells. Neither one came out of the California bond issue. And both of these are simply safety tests. It will be years more before efficacy tests happen. Even if things go extremely well, medicine moves at a snail's pace. So even if both these trials were ours, California won't see money back for a decade.

“But the real kicker is that the California money is a tiny pittance compared to what NIH hands out each year. Simply put, in a Bayh-Dole environment, the relative size of investment makes California's investment into a play against the house at a casino. Science is about being smart, but more than that, it is about being lucky and stumbling across something. Odds are stacked against us.

“Last, as others have pointed out already, embryonic stem cells have problems.”

From “donghofamily:”

“Do we really have $300 million a year to divert from education and basic services of the state? While this is a noble effort, we as California taxpayers cannot afford to fund stem cell research for the world when we can't even meet the basic education and health care needs of our state's citizens. The idea that we would go further into the hole on this is laughable.”

From “Speede:”

“CIRM is one of the greatest scams ever foisted on the people of California.....Now, CIRM, with $2 billion in its coffers, is asking for more taxpayer dollars. It is time to end CIRM and its unquenchable thirst for taxpayer dollars. A history of 10 years with not one therapy to show for $1 billion in expenditures is enough. California taxpayers can't afford another con job designed to enrich a small coterie of insiders.”

From “pressto:”

“Proposition 71 has been a complete waste of $6 billion in taxpayer dollars. What we need is reform on ballot measures so that any spending measure that would be funding out of the general fund requires a 2/3 vote to pass because it has been ridiculous bond measures like Prop 71 that has been the real cause of driving up our deficit.”

Final Wrap-up for Blue Ribbon Review of California Stem Cell Agency

SAN FRANCISCO – The blue-ribbon panel reviewing the operations of the $3 billion California stem cell agency is wrapping up its on-site sessions today and framing the general outlines of what it wants to say.

The panel conducted a final, one-hour public comment session that attracted only one person – yours truly. The bulk of this week's hearings were conducted behind closed-doors and were orchestrated by CIRM.

I presented a statement which can be found below and answered questions for about 20 minutes.

The panel plans to have a report ready for the December meeting of the CIRM board, where the public will have an opportunity to respond. Hopefully, the stem cell agency will post the report at least two business weeks prior to the board meeting. That will provide ample time for all interested parties to prepare thoughtful comments and plan to attend the meeting, if they so desire.

Here's the statement.

Statement to CIRM External Review Panel Oct. 15, 2010

Stem Cell Agency Apologizes for Its Choice of Poetry

The California stem cell agency stepped into a bit of an unnecessary mess last week that, of all things, involved poetry.

Perhaps it was a sign from above that government agencies should not try to commit literature, if you could call it that.

The case in point was a poem that won a prize from CIRM as part of its “stem cell awareness day,” a drum-beating effort to build support for human embryonic stem cell research. Winners of CIRM's poetry contest were announced last Wednesday in a widely distributed news release that was also posted on the CIRM Web site.

However, not only did the contest draw exceedingly few entries (only 18), the poem by one of the two winners was offensive to some who take their religion quite seriously. That in connection with research that already has more than its share of controversy.

In an item headlined “How to Offend 101,” one critic, J. Wesley Smith, wrote,

“One of the two top winners wrote a poem using the words of Jesus at the Last Supper to apply to embryonic stem cell research....

“Was it an intentional slam on Christians, many of which oppose ESCR, which the CIRM realized in retrospect would blow up in their faces?  Or did they think the poem, by using the words of Jesus at the Last Supper, would somehow appeal to Christians?  Or did they just think it was clever?   Whatever it was the judges were thinking–they weren’t thinking.”

Smith also used words like “hubris,” “arrogance” and “clueless.”

By Friday, CIRM had excised from its Web site the poem in question, which you can find at the end of this item. And the agency published an apology on its Web site that said,

“CIRM recently announced two winners of the second annual poetry contest, one of which contained some religious language that is identical to liturgical language used in the context of Christian and Catholic sacraments. The language introduces a religious element that we now realize was offensive to some people.

“We are deeply sorry for any offense caused by the poem. Neither the author nor CIRM intended for the language to insult or offend any religious group.

“When CIRM recognized that the language was of concern we removed all four poems from the CIRM web site and from the Stem Cell Awareness Day web site.”

CIRM's statement carried no comment from the three judges of the contest: Don Gibbons, CIRM's chief of communications, who said in the poetry press release that he studied poetry and creative writing at Indiana University; Margaret Hermes, also an Indiana alum and a “practicing poet and teacher,” and Don Reed of Fremont, Ca., a patient advocate.

The issue here is not the poem itself, which would have attracted little attention in a literary venue. But it was not published and touted privately. It was ballyhooed by a $3 billion California state agency, which has responsibilities to all of California – not just the scientific community.

CIRM had little to gain from running a poetry competition. Even under the best of circumstances, it would not generate sufficient PR payback to justify the time and expense involved, which was not much. And the prize for winners was equally neglible – “a framed stem cell image of their choice from CIRM’s Flickr web site.” Here is the poem from Tyson Anderson, a U.S. Army linguist from Tampa Fla.

Stem C.

This is my body
which is given for you.
But I am not great.
I have neither wealth,
nor fame, nor grace.
I cannot comfort with words,
nor inspire to march.
I am small and simple,
so leave me this.
Let me heal you.
This is my body
which is given for you.
Take this
in remembrance of me.

One Hour Public Access at Critical Two-Day Review of $3 Billion State Stem Cell Operation

The California stem cell agency today officially notified the public for the first time about next month's sweeping review of its operations and said the public may attend for one hour at the beginning of two days of meetings.

CIRM's announcement was the first such notice that it has given the public via its Web site about the sessions that begin Oct. 13 at its San Francisco headquarters. The announcement also said for the first time that the public can submit written comments and questions in advance of the meeting.

CIRM's announcement did not make it clear that the public would be barred from the remainder of the sessions. However, a separate agenda for the meeting, also the first to be published by CIRM, specified that public would, in fact, be banned from virtually all of the most comprehensive review ever of the $3 billion operation.

The California Stem Cell Report last week wrote that the agency planned to ban the public entirely from the sessions. It was the first public news of the external review outside the sparsely attended meetings of the CIRM board of directors. Yesterday, we pointed out that the ban is not in the best interests of either the public or the agency and that the secrect testimony would not accomplish the agency's goal of candor from witnesses.

Today's announcement from CIRM implicitly recognizes that the public has a right to attend the hearings. However, barring the public from the remaining 19.5 hours falls far short of being either open or transparent, something CIRM has had problems with for years. One hour could not even be considered paying lip service to the state Constitution's guarantee of a broadly construed right of public access to the doings of state government.

CIRM gave no reason for its marginal change of position. We are querying the agency concerning its reasoning.

Material posted by CIRM also shows a change in one of the panelists. Dropped is Myrtle Potter, former head of Genentech who now runs her own San Jose, Ca., consulting firm. No explanation was given for the removal of Potter. We are querying CIRM about that as well. She is being replaced by
Igor Gonda, CEO of Aradigm Corp. of Hayward, Ca., an inhalation drug product firm.

The agency also posted a 384-page briefing document that has been given to the eight panelists who will be reviewing CIRM's strategic plan.

We will have more later on all this.

Implications of a New Multibillion Dollar Bond Campaign for CIRM

The chairman of the California stem cell agency, Robert Klein, this week raised the possible size of a new bond issue to finance stem cell research to as high as $5 billion.

Klein made the comment in a piece by Ron Leuty in the San Francisco Business Times. Leuty reported that Klein, who directed the 2004 electoral campaign that created CIRM, said the new ballot measure could could come by 2016 and raise $3 billion to $5 billion.

Previously, the publicly reported figure topped out at $4 billion. Katie Worth of the San Francisco Examiner reported that number in August, which appears to the first disclosure in the media of the size of the bond issue. (She is also one of the few reporters that has attended a recent CIRM board meeting and written a story about it.)

Media reports of a new bond issue have significant implications -- political and financial -- for CIRM and how it is perceived by the public. To win voter approval of a bond issue will require a political campaign. The Prop. 71 in 2004 cost about $30 million. Another campaign is not likely to require as much, but the cost will run into millions. Funds will needed to be raised from many sources, some of whom will be making flinty-eyed judgments on the financial value of CIRM's activities on their particular enterprises. Some are likely to expect something in return for their campaign contributions.

The proposed bond issue also places CIRM squarely in a political context. Nearly all of its actions will be judged in the not-so-pleasant light of an electoral campaign. Klein acknowledges the need for politically acceptable results from CIRM. Not coincidentally they can also mean advancing the science and therapies.

Here is part of what Leuty wrote concerning Klein's discussion of another electoral campaign for a multibillion dollar bond issue.

"That may seem like a tough sell in a state smacked upside the head by a recession, but Klein is the ultimate salesman/evangelizer/patient advocate. He pulled together a powerful group of people cutting across political party lines and backgrounds to get Prop. 71 passed when most people had no scientific concept of stem cells."

Leuty continued,

"'Strategically, what we’re focused on is trying to make sure there is enough therapies advanced to Phase I or Phase II efficacy trials (where) voters of California can judge the performance and decide if they should approve another $3 billion to $5 billion,' Klein, the outgoing chairman of the San Francisco-based agency, told me in a phone conversation Tuesday. 'The voters are going to have to see real evidence.'"

Klein said CIRM will not run out of funding until late 2016 or early 2017, although different scenarios exist, depending on quickly CIRM hands out money. Leuty wrote,

"By then, many clinical trials will be well under way. Even if the National Institutes of Health starts funding basic embryonic stem cell research, Klein said, CIRM would be a natural partner for funding the translation of that work into bedside therapies.

"'In five or six years, we will have a very strong showing and evidence that when given stable funding we will have novel ways to reduce suffering,' Klein said."