California Stem Cell News: A Not-So-Good Story Line

If one is to believe Google, the top of the news today about the California stem cell agency is a story that relates how its $3 billion effort has failed to deliver on the emotion-ladened campaign promises of 2004.

The piece in the Los Angeles Times, the state's largest circulation newspaper, was ranked No. 2 in a Google news search this morning on the term “California Institute for Regenerative Medicine.” Ranked at No. 1 was a summary of the article. Yahoo news placed the Times article a tad higher than Google, declaring it was No. 1.

The story yesterday by Jack Dolan of the Times' Capitol bureau follows one earlier this month in the New York Times that warned that California voters are not likely to see a good return on their unprecedented investment in stem cell research.

Both stories highlight one of the major challenges facing the state stem cell agency, especially if CIRM seeks another $3 billion to $5 billion from voters in a couple of years.

To win approval of such a bond measure in a statewide election, it will take more than a few hundred research papers, one of the measures of success that CIRM uses. The papers may contribute to the development of the science, but voters expect more tangible results. They want to see paralyzed people walk, blindness cured and memories recovered – all of which are not likely between now and time for an election for more funding for CIRM.,

That is not to say that another bond measure is doomed, but it will take some great science and top-notch marketing – not to mention luck – to win approval of more cash for research.

The story that CIRM wants to see should be much different than Dolan's piece, which does not give the agency much to celebrate, at least in terms of PR.

Dolan wrote,

"Under (CIRM Chairman Robert Klein's) stewardship, the agency has funded research leading to hundreds of scientific papers, but scientists say marketable therapies for maladies such as cancer, Alzheimer's and spinal cord damage promised during the campaign remain years, if not decades, away."

Dolan cited the built-in conflicts of interest at CIRM. He wrote,

"'When you're talking about spending $1.1 billion dollars, there's absolutely no excuse for people making the decision to give themselves the money,' said Robert Fellmeth, executive director of the Center for Public Interest Law at the University of San Diego.

"While board members recuse themselves from voting on grants where they have a direct conflict, the mere presence of so many conflicted members is a concern, Fellmeth said. 'There is a quid pro quo atmosphere that develops, because you defer to each other.'"

Dolan additionally hammered at the high salaries at the upper levels of CIRM, a matter that resonates roundly and negatively with voters.

Little of what he wrote is new to the readers of this blog, but a piece in the Los Angeles Times reaches a new and far wider audience than that of the California Stem Cell Report. A story in the Times also stimulates additional links to the article, sometimes in a manner that does not cast CIRM in the best light.

The Scientist magazine linked to the story in a three-paragraph item that began like this:
“The California Institute for Regenerative Medicine has been plagued with criticisms and doubts during its first six years in operation, yet the chairman of the institute plans to ask state voters for another $3 billion in bonds in 2014 to keep the institute up and running.”

Then there was this headline from blogger Wesley Smith: “CIRM to Try and Sucker Californians Into Letting It Borrow Even More Money." Smith wrote,

"Who cares that California is falling into the ocean fiscally?  Who cares that our taxpayers are groaning under high taxes and an astonishing level of bond debt?  Not the California Institute of Regenerative Medicine.  Like the man-eating plant in (the play) 'Little Shop of Horrors,' its appetite is insatiable.  It wants more!"

Rankings of news stories on Internet search engines, of course, change over time, sometimes in a matter of hours. But pieces such as those in the New York and Los Angeles Times will still be part of the news background for CIRM come election time. Reporters from around the state and nation will find them as part of their coverage of the bond measure. More questions will be asked. And CIRM will need to find some good answers.

Second hESC Trial Scores Significant Media Coverage

FDA's approval of a second clinical trial involving a human embryonic stem cell therapy developed by Advanced Cell Technology attracted wide spread media coverage yesterday and today, but missing were some interesting sidelights.

Stories appeared from Boston to Los Angeles about the effort by the firm, which is headquartered in Santa Monica, Ca.

Alla Katsnelson of Nature magazine wrote,

"The trial will examine the safety of a therapy for Stargardt’s Macular Degeneration, an inherited juvenile eye disease affecting an estimated 1 in 10,000 young people in the US. As the disease progresses, a layer of the retina called the retinal pigment epithelium (RPE) degenerates, causing vision loss. It's hoped the new therapy would also work for other types of macular degeneration, a widespread cause of blindness, particularly in the elderly....

“Macular degeneration has been seen as stem cell therapy’s low-hanging fruit because the cells that need replacing are so accessible, both for delivering the treatment and for monitoring its effects. The eye is also an immune-privileged site – meaning that injections won’t elicit an immune response. Last year, the pharmaceutical giant Pfizer agreed to back the work of researchers at University College, London, who are developing a similar therapy."

Carolyn Johnson of the Boston Globe was one of the few mainstream media writers to note the company's stock price. She said,

"ACT has withstood financial struggles over the past few years, and its stock price closed on Friday at under 5 cents a share. But the small clinical trial that it has gained approval for — to treat 12 patients with Stargardt’s macular dystrophy — will make it the second company in the United States to test a human embryonic stem cell treatment.

"'It’s been a long road. . . . We’ve had our telephones turned off a few times,'’ said Dr. Robert Lanza, chief scientific officer for ACT. 'We’ve hung in there.'"

Unmentioned in the stories was the fact that ACT, lured by the passage of the measure that created the $3 billion California stem cell agency, moved its headquarters from Massachusetts to California in 2005. While ACT has never received a grant from the stem cell agency, it is one of the few companies that has complained publicly at a meeting of CIRM directors about a conflict of interest on the part of a grant reviewer.

The comments by Stephen Kessler in August 2008 were cut off by CIRM Chairman Robert Klein, who said directors needed to discuss the names for CIRM-funded labs before going to lunch.

Also not mentioned were reports that ACT is one of the few companies likely to have applied in CIRM's $50 million clinical trial round.

CIRM carried a straight-forward item about the trial on its research blog.

Writing on his blog, researcher Paul Knoepfler of UC Davis called it “a great day.” He said,

“I think there is reason for cautious optimism. Cell therapy-based approaches to treating blindness together represent a fundamentally new, exciting area.”

Here are links to other stories: New York Times, USA Today, Xinhau, AFP, Science, Los Angeles Times, ACT news release.

California Stem Cell Directors Take Up Klein's New Role, Future Priorities

An old saying in the world of governance and politics goes like this: “The king is dead. Long live the king.”

It all has to do with transition, power and, in the case of the California stem cell agency, possibly new initiatives.

On Dec. 1, those issues and more will be on the table publicly at the agency. The CIRM directors' Governance Subcommittee is scheduled to deal with at least one aspect of the looming departure of Robert Klein, who has been the majordomo of the Golden State's stem cell experiment since its inception six years ago.

Klein has said he will leave in December at the expiration of his six-year term as chairman. However, should a successor not be chosen, it is conceivable that he would stay on.

The Governance Subcommittee, headed by former Hollywood film studio chief Sherry Lansing, is making plans, however, for the “chair emeritus” after he vacates the post. The agenda for the Dec. 1 meeting has this tidbit: “Consideration of future assignments to and volunteer support by Chair Emeritus.” The agency, however, provided no further information for the public, as is its wont.

One likely possibility is that Klein will continue to work on the multibillion dollar bond measure that he has been talking up for CIRM during the last several months. The proposal could range as high as $5 billion and be on the ballot in less than two years. It is not too early to begin lining up that effort, given magnitude of the challenge. California is mired in a $25 billion financial mess that makes approval of another bond measure problematic, unless something changes. And over the weekend The Sacramento Bee published a piece by Kevin Yamamura that said that state is most likely to be “swimming in red ink” for the next four years.

Also on tap at the Governance meeting is a related and equally cryptic proposal: “Consideration of budget allocations and structural priorities.” Again, the public was not given access to any additional information about this $2 billion matter. That is the amount that the agency has left to spend out of its original $3 billion.

However, the topic of the future spending was explored behind closed doors for three days in October by a blue-ribbon, external panel selected by CIRM, which orchestrated the proceedings. Nonetheless, it was – or should have been --- the most sweeping review ever of CIRM's program. The panel's report is scheduled to be released about the time of the Dec. 1 Governance session.

The panel is expected to make recommendations about future initiatives, possibly identifying some ripe targets that past funding did not hit. CIRM is already sharply focused on funding activities that are likely to generate results that will find favor with voters when a new bond measure is presented.

The Governance meeting is a prelude to the Dec. 8-9 meeting of the full board of directors in Irvine. Last month Klein said he was hoping to bring the entire review panel, including Nobel Laureate Sir Martin Evans from Great Britain, to that meeting for a discussion of the panel report.

Klein also said last month that he wanted to have another full board meeting around Dec. 15 to deal with selection of a new chairman and vice chairman or chairmen. The board cannot pick any individual they want. Instead it must choose from candidates nominated individually by the governor, treasurer, controller and lieutenant governor. Of course, CIRM directors do not have to vote for any of the candidates if they are not to the directors' liking. The board could instead ask for new candidates to be submitted by the politicos. Also, if the current holders of those statewide offices do not make a nomination, the responsibility would fall to those elected earlier this month to replace them.

The public can participate in the Governance meeting at site in San Francisco(2), Los Angeles(2), Palo Alto, Sacramento, Emeryville and Irvine. Specific addresses can be found on the agenda.

Knoepfler: NY Times Piece on Stem Cells Not Up to Snuff

We asked Paul Knoepfler, a UC Davis stem cell scientist, if he would care to comment additionally on our item Monday concerning the critical remarks about stem cell research, particularly in California, by Nicholas Wade of the New York Times.

Knoepfler had sharply criticized the article in a piece on his blog, which we differed with on Monday.

Here is what Knoepfler sent along to the California Stem Cell Report.

“David, I disagree with your take on Wade's article. In my opinion the bottom line of what Wade is arguing in his NYT article can be summed up as follows:

“'Scientists, funding agencies, and research rarely succeed. When they do succeed, it is a result of luck. Most often scientists fail spectacularly, in which case they create an illusion that their work is actually making progress when it isn't, or they commit fraud. NIH, NSF, and CIRM have different approaches to funding research, but none are or will be successful overall.'

“To support these arguments, Wade presents no data and no quotes. Apparently readers are supposed to simply rely upon his wisdom.

“The 'icing on the cake' for me is that Wade, despite serving up a veritable Las Vegas buffet of negativity, provides absolutely no proposed solutions to the problems he perceives. He also shares no keen insight into what the future holds, except presumably research, in his opinion, continuing to waste massive amounts of taxpayer money. Where are his prognostications for 2011?

“Contrast Wade's article with the piece by Gina Kolata in the same special section of the NYT. Ms. Kolata's piece is clear, well written, balanced, includes quotes from scientific leaders, and makes predictions. My opinion is that Wade's piece was thrown together at the last minute without editing as a counterpiece to Ms. Kolata's.

“The end result is a confusing article that disparages science and misinforms readers. As someone who has read loads of Wade's previous articles and enjoyed them, I found this one disappointing and disturbing.”

Kerfuffle over NY Times Take on California's Stem Cell Program

Last week, the New York Times published an article that was critical of California's approach to funding scientific research, quickly prompting denunciations that called it a “hit piece” and an “unbelievable attack.”

We differ with those characterizations, some of which seem to stem from a misunderstanding of a comment in the Times about how the NIH is like a manager of a stock index fund, as opposed to California's narrower focus.

The Nov. 8 piece was written by Nicholas Wade, who has had a long and respectable career in science reporting. The article was carried in a special section on “prognostications” about what could be coming up in 2011 in science. The article was not intended as a “balanced” news story. Rather it was an analysis based on Wade's years of covering science. That distinction might have been clear in the print version of the section, but it was easily overlooked on the Web version of the Times. That led to some misunderstandings by readers based on comments that we have read.

Basically Wade said that California – as opposed to the NIH – has made a $6 billion bet (including interest) on a narrow field of science. He wrote,

“By allocating so much money to a single field, California is placing an enormous bet on a single horse, and the chances are substantial that its taxpayers will lose their collective shirt.”

Wade contrasted that approach to the NIH, which funds all sorts of scientific research, instead of just stem cells. He wrote,

“...(T)he National Institutes of Health and the National Science Foundation are like the managers of a stock index fund: they buy everything in the market, and the few spectacular winners make up for all the disasters.

“But just as index fund managers often go astray when they try to improve on the index’s performance by overweighting the stocks they favor, the government can go wrong when it tries to pick winners.”

Writing on his blog Nov. 9, UC Davis stem cell researcher Paul Knoepfler described Wade's article as a “hit piece.” Knoepfler said,

“The NY Times has allowed Mr. Wade to publish in essence an opinion piece smearing stem cell researchers in their Science section.

“NIH is incredibly strict and deliberate in what it funds. NIH funds approximately only the top 10-15% of all grant applications after thorough peer review, which is an extremely low percentage. This hardly reflects 'buying everything', but rather is just the opposite.”

It is clear that Wade's piece reflects his opinion and would not be carried on the front page of the NY Times as a news article. However, his broad-brush analogy about the NIH being akin to a manager of a stock index fund is on the mark. The NIH does not limit its funding to only one brand of research. It is certainly deliberate and approves a small fraction of applications, but those represent a broad range of approaches, just as an index fund for the entire stock market has oil, auto, tech, health, insurance, soap and other companies represented in its portfolio. If Wade were to carry his comments further, he might say that California has only bet on or invested in the biotech sector. That creates an investment risk, looking at it from a financial viewpoint.

Knoepfler also differs with Wade's assertion related to dubious claims involving stem cell research. Wade wrote,

“Stem cell researchers have created an illusion of progress by claiming regular advances in the 12 years since human embryonic stem cells were first developed. But a notable fraction of these claims have turned out to be wrong or fraudulent, and many others have amounted to yet another new way of getting to square one by finding better methods of deriving human embryonic stem cells.”

Knoepfler described that as an attack on embryonic stem cell research and researchers.

“He(Wade) says that us scientists have 'created an illusion of progress' with our claims and that a 'notable fraction of these claims have turned out to be wrong or fraudulent'. Wow. Can you please give me some facts to support such aggressive claims?”

Wade did not carry any evidence supporting his assertion but also carried this sentence,

“Stem cell scientists, while generally avoiding rash promises themselves, have allowed politicians to portray stem cells as a likely cure for all the major diseases.”

Stem cell research has indeed been susceptible to considerable hyperbole, much of it coming during the 2004 election campaign that created the California stem cell program. We are likely to see more as the stem cell agency becomes increasingly serious about asking voters for another $5 billion(actually perhaps $10 billion including interest), as early as 2012.

California patient advocate Don Reed weighed in with a comment on Knoepfler's blog. Reed described the Times article as an “unbelievable attack.” He said that the California stem cell agency has awarded $1 billion and “received” $1 billion in matching funds. In fact, the agency has not received anything remotely like that sum. It has required matching funds on some grants, notably lab construction projects, but that cash is ginned up by applicants. It is reasonable to assume that a goodly portion of those funds would have found their way to the respective institutions even without CIRM's matching requirements.

Wade also had this to say,

“Strangely, for a project that is aimed at regenerative medicine, the arbiters of stem cell research have largely neglected the free lesson that nature is offering as to how regenerative medicine could actually work. Many little animals, like newts and zebra fish, do regenerate parts of their bodies. But their recipe is the reverse of that presented by the advocates of stem cell therapy. Instead of taking a stem cell and trying to convert it into a well-behaved adult tissue, animals like the zebra fish start with the adult cell at the wound site, and walk it backward into a stemlike state from which a new limb grows.

“For the California Institute for Regenerative Medicine to invest its $3 billion in studying newts, rather than building new science buildings on every state campus, might seem the best way of understanding regeneration, but that would be hard to explain to California’s voters, who have been assured stem cell cures are just around the corner. Even if governments do better to avoid picking winners among basic research fields, they can play a necessary role in supporting specific scientific infrastructure that lies beyond the means of individual researchers or universities, like atom-smashers or the human genome project. But even these projects are not guaranteed success.”

Wade's bottom line?

“Basic research, the attempt to understand the fundamental principles of science, is so risky, in fact, that only the federal government is willing to keep pouring money into it. It is a venture that produces far fewer hits than misses.”

Coffey Not Committed to Moving to California Despite $4.9 Million Grant from CIRM

Last Thursday directors of the California stem cell agency awarded $4.9 million to an eminent British scientist after being assured by CIRM President Alan Trounson that his relocation to the Golden State was all but a done deal.

The $3 billion agency put out a news release in which CIRM Chairman Robert Klein hailed the move by Peter Coffey to UC Santa Barbara. Klein said,

“Recruiting internationally renowned stem cell experts such as Dr. Coffey builds a critical mass of stem cell leadership in California to drive the creation of innovative therapies for patients suffering from chronic disease or injury.”

The next day, the Financial Times of London quoted Coffey as saying he was not relocating to California. It was the second faux pas in CIRM's new, $44 million research recruitment program and raised questions about whether CIRM officials had a firm grasp on Coffey's status and their role in the touchy negotiations. It also raised questions about whether Coffey and UC Santa Barbara had met the terms of the grant application.

The RFA for the recruitment program makes several references to requirements that a recipient be a full-time employee at a California institution. Here is just one:

"The applicant institution will make adequate commitments to the PI including appointment to a full-time faculty position."

Friday's Financial Times article by Clive Cookson said,

"Although Mr Klein’s statement suggested that Prof. Coffey would be moving his base to California, Prof. Coffey said that impression was misleading. 'I am staying here [in London],' he said, 'though I can foresee more and more pressure from CIRM to up sticks and move there.'

"He said the $4.8m (sic) grant would enable him to set up a second laboratory at UC Santa Barbara, where he is already an adjunct professor, and accelerate his research."

Late Friday, we queried Coffey about the Financial Times story. On Saturday morning, we sent a query to the stem cell agency and UCSB. We told all the parties we would carry their responses verbatim when they were received.

Coffey has not replied. Dennis Clegg, co-director of the Santa Barbara stem cell program, said,

“UCSB is working hard to recruit Dr. Coffey to a full-time position, and CIRM has provided an invaluable tool to help us do that. However, as common sense would dictate, our negotiations are a private matter.”

Don Gibbons, CIRM's chief communications officer, said,

“By definition, these applications come from PIs who are not currently, eligible for CIRM funding. They are intended to be used as a recruitment tool by the CA institution. Once UCSB and Dr. Coffey decide when and how he will come to UCSB, CIRM will issue the award if Dr. Coffey's new position meets the requirements of the RFA. We would be delighted to see Dr. Coffey relocate to California on a full-time basis, but we respect the fact that he and UCSB will have to make that decision.”

At last week's board meeting at UCLA, Klein specifically asked Trounson about the status of Coffey's recruitment before calling for a vote on the grant. Coffey's name, however, was not specifically mentioned in keeping with CIRM's practice of withholding the names of winning applicants until after the board votes. Trounson assured the board that it was virtually certain that the researcher would be joining UCSB. The question of full or part-time work was not mentioned. Trounson said the applicant was “clearly one of the best scientists in the world.”

Last summer, the CIRM board put off action on Coffey grant. The agency said in August,

"The candidate being brought forward wanted more time to notify their current home institution.”

Coffey was quoted last month as deploring cuts in research in the UK. The Financial Times story said that if funding were not increased Coffey said he might have “to make members of his research team redundant and he would then succumb to the “enormous pressure” to move abroad. He said California was “very attractive” to scientists. The newspaper said the efforts by Coffey and other prominent scientists were subsequently successful in maintaining funding.

Last April, the board approved its first recruitment award. It was a $6 million inducement for Rob Wechsler-Reya to move to the Sanford-Burnham Institute in La Jolla from Duke University. He was identified as the recipient in an item on the California Stem Cell Report prior to the expected action by the board. Wechsler-Reya subsequently said he had not made a decision to come to California, which appeared to come as a surprise to CIRM officials. CIRM attempted to set a June 30 deadline for negotiations. Finally, in August, Burnham announced that they had successfully concluded a deal with the Duke researcher to come to California as a fulltime researcher.

In California, the chief institutional beneficiaries of CIRM's $44 million recruitment program are enterprises that are linked to members of the CIRM board of directors. Only academic and nonprofit institutions may apply. A relocation by Coffey to California would be a major international coup for the state and UC Santa Barbara.

Slim Coverage Today of California Stem Cell Agency Awards

The California stem cell agency's latest grants – more than $70 million – drew scant attention in the media this morning.

Most of the coverage was a routine rehash of the CIRM news release. Here are links to the various stories that surfaced today: Keith Darcé of the San Diego Union-Tribune, Ron Leuty of the San Francisco Business Times, Richard Halstead of the Marin Independent Journal, Loralee Stevens of North Bay Business Journal, Pat Brennan of the Orange County Register.

Here are the press releases from recipient institutions that popped up this morning in a search.
University of California, UC Irvine, Cedars-Sinai.

Stem Cell Agency Approves More than $70 Million Including Signing Bonus for Star at UCSB

LOS ANGELES -- The California stem cell agency today awarded $67 million for translational research and approved one appeal from a scientist whose application was turned down by grant reviewers.

The grants are a “key element of CIRM's pipeline to the clinic,” directors were told. The research is aimed at creating a “development candidate ready for IND-enabling preclinical development” or making progress on a development candidate.

Sophie Deng, an ophthalmologist at UCLA, was successful in her pitch to reverse a negative decision by reviewers. Following her presentation to the board, CIRM Director Jeff Sheehy, vice chairman of the grants review group, said the $1.5 million grant was a “no brainer.” He said it could lead to FDA approval of a treatment already being used in Europe.

One business, iPierian, Inc., of South San Francisco, was awarded $5.7 million, which will come in the form of a loan, assuming CIRM completes its paper work. James Harrison, outside counsel to the board, said that more documents needed to be processed. Ipierian is heavily backed by venture capitalists who contributed more than $6 million to the ballot initiative campaign that created the Calfiornia stem cell agency. The firm has already received a $1.5 million grant.

Directors put off action on an appeal petition by Leif Havton of UCLA as they were pressed for time at midafternoon. Members of the board needed to catch flights and lost a quorum. The board concurred earlier with reviewers' negative decisions on other two appeals by Frederick Meyers and Kit Lam of UC Davis and WenYong Chen of the City of Hope.

Another application, 1778, related to Parkinson's Disease was sent back to CIRM President Alan Trounson for additional review. The board has funded little research connected to Parkinson's because of the dearth of researchers in that area in California. Director Joan Samuelson, a patient advocate for Parkinson's Disease, pushed for funding of the grant.

Separately, the board awarded a $4.9 million grant to Peter Coffey of the United Kingdom, who was described by Trounson as “clearly one of the best scientists in the world.” The grant is aimed at helping to recruit Coffey to UC Santa Barbara. It was the second recruitment award by CIRM.

Coffey is already collaborating with Dennis Clegg, co-director of the UCSB Center for Stem Cell Biology and Engineering, in connection with another CIRM grant.

Here is a link to the CIRM press release on the awards.

$80 Million to Be Given Way Later Today

LOS ANGELES – The board of the California stem cell agency begins its meeting this morning with consideration of requests for $80 million for translational research high on its agenda, including four appeals by scientists rejected by reviewers.

Also on today's agenda is a proposal for modification of the grant appeal process. It would provide a formal way for the CIRM board to send a grant back for re-examination by reviewers.

The board met Wednesday night mostly in a closed-door session dealing with the evaluation of CIRM President Alan Trounson.

The board briefly discussed projections for spending through the current decade but arrived at no firm conclusions. Director Michael Goldberg, a venture capitalist, said the agency needed to settle on a fixed projection. He said it could be modified but that CIRM should not be caught up in “scenario du jour” plans for strategic spending.

The meeting can be heard on an Internet audiocast and at a teleconference location in Pleasanton. Directions for both can be found on the agenda.
We will have more coverage of the meeting later today.

City of Hope Scientist Seeks to Reverse Negative Finding on Grant Application

A fourth researcher is seeking to overturn a negative decision on a grant application that comes before the California stem cell agency later today.

The scientist is WenYong Chen of the City of Hope in Duarte in Southern California. Chen's 4-page petition said the reviewers may not have “fully appreciated” certain points of the proposal.

CIRM directors will take up the applications for $80 million in translational research funding at their meeting this afternoon in Los Angeles. Three researchers have already appealed the negative decisions on their proposals. Summaries of the reviewer comments on all the grants can be found here.

How Fast Should the Stem Cell Agency Spend its Remaining $1.6 Billion?

Directors of the California stem cell agency will give away more than $80 million this week and wrestle with the question of what to do with their remaining $1.6 billion and how fast to spend it.

The $1.6 billion is a new figure for the public. Previously it was assumed the agency had $2 billion left, having committed $1 billion in awards. However, $2 billion figure did not include operational expenses, such as interest, legal costs and $180 million for administration through 2016.

The CIRM board is not likely to make a final decision on its strategic spending plan at the meeting Wednesday and Thursday in Los Angeles and at UCLA. Directors will have more information to work with in December when they consider the report of CIRM's external review panel, which conducted three days of hearings last week. The public was barred from most of those proceedings, and there are few clues concerning the direction of the blue-ribbon panel's recommendations.

Here are links to key documents on CIRM's future spending scenarios: Projected cash flow, memo on cash flow and more projections.

Also before the board are applications for $80 million for early translational research. Three applicants whose proposals were rejected by reviewers have filed petitions seeking to reverse the decisions. They are Sophie Deng of the Jules Stein Eye Institute at UCLA, Leif Havton, also of UCLA and Frederick Meyers and Kit Lam of UC Davis. (You can find their appeals by clicking on their names.)

The appeal process itself, which has troubled the board for several years, may also be modified this week. A proposal that would formalize a process for sending grants back to reviewers for additional examination is on the table. The staff information on the plan said,

“When a material dispute of fact exists and the Board is unable to resolve the issue at the meeting at which the application is considered, the Board may conditionally deny funding for the application, subject to a limited analysis of the factual issue or issues identified by the Board. The option for additional analysis is not a reconsideration of the application as a whole, but is limited to consideration of the issue or issues identified by the Board. This option should be reserved only for those circumstances in which the Board is unable to reach a decision at meeting at which the application is presented because of the factual dispute or question. Programmatic issues, such as whether the agency’s portfolio is well-balanced among diseases, should not be a justification for additional analysis, nor should clear errors in the review of an application that have been identified by staff and presented to the Board during the meeting at which the application is considered.”

Also before the board is CIRM's second recruiting grant to a scientist, as yet unidentified. It would provide $4.9 million to the “mid-career neuroscientist” in addition to incentives provided by the recruiting institution. The reviewer summary said,

“Reviewers characterized the PI’s research vision and plans as truly innovative, novel, ambitious, and important. The research focus on devastating and currently incurable blinding diseases was viewed as highly significant, with a potential to revolutionize the field. Reviewers were confident that the PI’s research would contribute to both the critical basic science and preclinical advances that will underlie novel therapies.”

Other items before the board include a proposal to spend $600,000 to provide seed money for an online, open-access journal for translational stem cell research, and changes in the loan administration policy. Most of the changes appear to be a straight-forward clarification of language that removes questions by business, which is the target of the loan program that was once described as a $500 million effort.

Missing from the proposed changes is one dealing with automatic forgiveness of loans to businesses under specified conditions. It appears to be connected to an application from iPierian, Inc., in the early translational round. However, the changes would apply to all loans to businesses and remove financial ambiguity that could be a stumbling block for some enterprises.

The changes came before the Finance Subcommittee last week, but some board members raised questions about them. Plus the panel did not have a quorum and could not legally act. The Finance Subcommittee has scheduled a meeting for Oct. 26 to consider the proposal again. It would then go to a special teleconference meeting in the board, if necessary.

CIRM has not provided a link to the loan forgiveness changes in the Oct. 26 agenda, but they can be found in a document here.

The public will be able to participate in the CIRM board meeting this week at teleconference locations in Washington, D.C., and Pleasanton in Northern California. The meeting can be heard on the Internet as well, but that audiocast does not permit participation.

Specific locations and instructions for the audiocast can be found on the agenda.

CIRM Poetry Kerfuffle Attracts More Publicity

The flap over the California stem cell agency's poetry contest continues to draw attention with the most recent coming yesterday on the widely read Huffington Post blog.

An item by John Lundberg, who describes himself as a poet, teacher and a former Wallace Stegner Fellow at Stanford, said the use of “language considered sacred by most opponents of stem cell research in order to promote the research is, well, provocative.”

Lundberg's item drew a wide range of comments from readers. One said the $3 billion stem cell agency was “cowardly” for pulling the offending poem and apologizing. Another said,

“Embryonic stem-cell research requires the destruction of a human embryo - a living being that, if not destroyed, becomes a human being. Fact, not opinion.”

Last week, The Associated Press also picked up the story. The news service reaches into news outlets internationally, although it is not clear whether the story was distributed that widely. Accounts of the flap have also appeared elsewhere on the Internet, mainly on sites devoted to opposition to hESC rsearch.

Is this affair a plus or minus for the stem cell agency? The controversy has raised somewhat the visibility of the stem cell agency. However, generally the agency is more inclined to seek favorable mention of its research efforts, which this poem and subsequent publicity do not. The agency's action actually energizes opponents, who see it as a validation of their hostile views of CIRM. If the agency has slipped below the horizon of some opponents, it reminds them they still have a significant foe lurking out there who needs to be dealt with. The pluses, if any, are neglible.

Don Gibbons, chief communications officer for CIRM and one of the judges of the poetry contest, took issue last week with our characterization that the poetry contest was not worth the effort under any circumstances. He pointed to articles on the Los Angeles Times and USA Today Web site that were published prior to the controversy as worthwhile mentions of CIRM. Gibbons faulted us for not mentioning them.

Last week, the public sessions of the external review of CIRM highlighted, however, the need for the agency to focus on its higher priorities. Reviewers said more than once that they were concerned about the “bandwidth” and size of staff at CIRM compared to its ambitious goals.

Our take: Handing out prizes for poetry probably is not one of the essential tasks for CIRM's small staff.

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

Does the Stem Cell Agency Have Enough 'Bandwidth' to Do The Job?

SAN FRANCISCO – A blue-ribbon panel examining California's $3 billion stem cell agency began its second public session this morning with some of its members saying they are impressed by what they have learned so far and with some expressing concern about whether CIRM has enough “bandwidth” to achieve its goals.

Alan Bernstein, chairman of the panel and executive director of the Global HIV Vaccine Enterprise of New York, described the agency as a “very exciting experiment in science,” one that the “world is watching.” Others also said they were impressed by how much CIRM has accomplished during its nearly six-year existence.

But panelists also said it could be difficult for the agency to do all that it is proposing. Richard Klausner, managing partner of The Column Group, a San Francisco venture capital firm, and Igor Gonda, CEO of Aradigm of Hayward, Ca., were among those concerned about CIRM's “bandwidth” problems. Klausner said he was “completely amazed” at what CIRM is trying to accomplish. But both expressed concern about whether CIRM had the necessary “resources” to do all that it proposes

Their comments apparently referred to the size of CIRM's staff, which was limited by Prop. 71 to 50 persons in addition to a 6 percent cap on its administrative budget. The agency has never had 50 employees although CIRM President Alan Trounson earlier this year warned that the quality of work was in danger because of the limit. Since then, the legislature has removed the cap in a new law that will take effect Jan. 1. However, according to CIRM officials, the size of the CIRM staff is not likely to exceed about 54 persons any time soon.

Although recruiting and hiring usually takes months, CIRM also does not seem to be making a running start on its opportunity to hire more staff. The agency has not yet posted significant numbers of new openings on its Web site. One key position, the new vice president for research and development, has been vacant for about 14 months. The post was supposed to represent a major effort to engage industry, which has been less than happy about its meager share of CIRM grants, about 4.5 percent.

The limit on CIRM staff has forced it to rely heavily on outside contractors, whose expenses are the second largest component in its operational budget. This year contractors are expected to cost $2.8 million, up 21 percent from last year.

This morning, the external review panel conducted a three-hour public session and then moved into a closed-door meeting. Today's meeting was consumed by presentations from CIRM Chairman Robert Klein and others. Public comment was called for with about 15 minutes left in the session. No members of the public offered comments, and only perhaps one or two were in attendance. Another one-hour public comment session is scheduled for tomorrow morning at 8:30 a.m.

Klein and others offered an overview of the agency, its history and underlying philosophy. He noted that the use of bond financing (money borrowed by the state) was aimed at assuring long-term financial stability for scientific research. He also said the debt, which will extend over 42 years, will be paid by the beneficiaries of the results of the research. At one point, he noted that borrowing the $3 billion will cost another $3 billion or so in interest.

Scientist George Daley of Harvard, another of member of the external review panel, raised a question about whether efforts such as CIRM are a threat to the “paradigm” of federal funding of research through the NIH.

CIRM Vice Chairman Art Torres said that the results of CIRM research will benefit the entire nation. Klein said the California effort will put pressure on Congress to develop more stable ways of financing scientific research.

Blue-Ribbon Panel Hears Recommendations for More Openness at California Stem Cell Agency

SAN FRANCISCO – Only four members of the public attended the first day of a blue-ribbon review of the operations of the $3 billion California stem cell agency during the brief period permitted for public comment.

The panel shut down its public session after about one hour and moved from the Marriott Hotel in San Francisco to CIRM headquarters to continue the meetings behind closed doors.

The small number of persons at the public comment session was to be expected. The agency made a late decision to permit public comment and then two days ago changed the location. Moreover, even CIRM board meetings rarely attract more than a handful of people. But again, CIRM makes little attempt to actively publicize directors' meetings.

Public comment sessions are also scheduled for tomorrow and Friday morning. The specifics and location can be found here. 

Three of the persons appearing this morning before the panel had type one diabetes and praised the agency for its search for therapies. One, Jessica Ching, is involved in the medical device and marketing field. She urged the panels to ensure that financing and development of commercial products are the primary goals of CIRM's efforts.

The fourth member of the public was yours truly. I read a statement to the panel urging more openness and transparency on the part of the agency and recommended several specific changes. In response, several members of the panel commented about the importance of openness in generating public trust. One later noted that scientists sometimes have difficulty understanding the need for transparency.

Here is the statement.
Statement by California Stem Cell Report to CIRM External Review Panel

Public Still Barred from Sweeping CIRM Review

The California stem cell agency confirmed this morning that the public remains barred from the key sessions of this week's sweeping review of the operations of the $3 billion public enterprise.

In response to a query, Don Gibbons, chief communications officer for CIRM, said,

“The public is only invited to the sessions that are marked as public.”

We raised the question because CIRM removed information this week from its Web site that explicitly said the public was banned. Also removed was information about the location, time and subjects of the closed-door proceedings. The  new announcement, posted just two days ago, additionally said that more time was being allotted for public comment.

The external review of CIRM,  the most comprehensive ever, begins this morning at San Francisco's Marriott Hotel.

We will be providing coverage today of the proceedings that we have access to.

More Time for Public Comment at CIRM Review But Doors Still Closed Otherwise to Public

Making a last minute change, the California stem cell agency has decided to allow more time for public comment during the sweeping review this week of its operations, but still will apparently bar the public from hearing testimony by witnesses.

The first public comment session will come tomorrow morning at 8 a.m. Other public comment sessions will be on Thursday and Friday mornings.

In the announcement posted just yesterday on the CIRM Web site, the agency also changed the location of the public comment sessions from CIRM headquarters to the Marriott Hotel in San Francisco.

The new information on the CIRM Web site removed an earlier agenda that said that the public would be barred from the panel's other sessions. However, this afternoon when we encountered Don Gibbons, CIRM's chief communications officer, at CIRM headquarters, he did not mention any change in policy. But that encounter was before we saw CIRM's new announcement, and we are querying Gibbons again concerning the likelihood of a change.

Also posted on Monday was a 29-page report (dated Oct. 8) by CIRM Chairman Robert Klein that will be presented to the blue-ribbon panel that is conducting the most comprehensive review ever of the $3 billion agency.

Our view on these last minute changes? The notice comes too late for all nearly all interested parties to find the time and make the effort necessary to prepare thoughtful comments. Plus the public still is apparently banned from hearing information that will be critical in determing the future direction of an agency that is spending $6 billion (including interest) of taxpayer funds.

We first wrote about the external review on Sept. 23. At that time, CIRM had not notified the public that the external review would occur nor had it solicited publicly any comments from interested parties, although the review had been planned for many months. Nor was any provision being made for public testimony at the review. CIRM has changed its position somewhat, but the public is still barred from what essentially is its own business.

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.

Parsing Statistics vs. the Reality of Biotech Concerns About CIRM

The California stem cell agency is missing the essential point of complaints from the biotech industry concerning CIRM's record on funding commercial research.

In its response to the biotech concerns, CIRM parsed statistics compiled by BayBio, the biotech industry group in Northern California, but ignored the reason for the private dinner meeting in August between top executives of the $3 billion agency and the area's stem cell firms.

Industry is less than happy with the California Institute of Regenerative Medicine. BayBio and the Orrick law firm did not bring together all those CEOs in August to pat CIRM on the back.

The industry concerns are not new. They have been around for several years. They have been acknowledged more than once by CIRM directors, some of whom have spoken pointedly about the need to funnel more cash to stem cell businesses. It is not just a matter of spreading money around equally. It is a matter of actually creating usable medical products, something that Stanford, the University of California and nonprofits are not going to do.

Director Jeff Sheehy, a patient advocate member of the CIRM board who works at UC San Francisco, said at the August CIRM board meeting,

“From the minute I've been on this agency I've heard...(at)all the industry meetings -- I've heard (that) we've got products waiting for money.”

According to the transcript of the meeting, CIRM Chairman Robert Klein, a real estate investment banker, acknowledged that CIRM does not have a “big supply” of grant reviewers with industry expenence – one of the problems cited by BayBio for the lack of grants to business. Finding them is “difficult,” Klein said.

Director Philip Pizzo, dean of the Stanford School of Medicine, additionally raised a question about CIRM's outreach to business.

“If industry has got things in the pipeline...are there ways that we could seed this to happen in more novel manners?

“Have we had, for example, as part of our strategic planning effort, an off-the-record kind of think tank between industry leaders, academic, venture capitalists in the same room at the same time, not separate -- would you buy into this ...approach -- but really coming together and say if we could create the world differently, how might we think about novel ways of approaching these kinds of both research and translation efforts?”

The question went unanswered at the board meeting. The strategic plan, however, comes up next week at CIRM headquarters in San Francisco when a blue-ribbon panel of external reviewers will conduct a closed-door examination of CIRM and its performance. The meeting's agenda, however, does not mention the stem cell industry's concerns.

Industry executives have been reluctant to go public with their issues, understandably wary of offending a financially powerful organization. Privately, they are more frank. We have heard bitterness and frustration from a number of them.

The industry found an unusual ally, at least on this issue, in Consumer Watchdog's John M. Simpson, who worked closely with some firms during CIRM hearings on its IP policy. He came up with a constructive proposal in June to deal with business issues that was brushed off by Klein.

But, as on any matter, there is not complete unanimity within the industry about CIRM. Funded firms are not likely to complain much.

CIRM has an additional $5 billion reason to move concretely to deal with biotech's concerns. Klein is touting for the ballot a CIRM bond measure of that magnitude, possibly in two years. The electoral campaign that created CIRM six years ago cost $30 million. Another ballot measure will run upwards of that amount, which means raising buckets of cash. And the only likely major donors will come from the biotech industry and its investors.

(A footnote: CIRM disputes statistics produced by BayBio on the percentage of awards given to business. We suspect the industry's figures were based on earlier grant numbers published by CIRM. The agency's totals change each time it approves another grant round every month or so. The presumably old percentages probably indicate that BayBio has been stewing over this issue for quite some time. BayBio has also filed a comment on an earlier item on this subject. Its carefully worded remarks said the August meeting created “a renewed sense of collaboration and areas to address.” BayBio did not speak to CIRM's criticism of its statistics.)

Stem Cell Agency Says It Is "Not Biased Against Industry"

The California stem cell agency responded today to an item reporting dissatisfaction on the part of the biotech industry concerning its meager share of the $1 billion that CIRM has awarded so far.

Don Gibbons, chief communications officer for the agency, filed his remarks earlier today as a comment on the second piece we wrote on the subject. (Here is a link to the first.) Because of the important nature of the controversy, we are reprinting his statement verbatim below to give it greater visibility. We are sure it is not the last to be heard on the subject from either the agency or industry.

Here is what Gibbons wrote as a comment on the item on the California Stem Cell Report.

“Your post distorts the facts. The document you quote from BayBio is not a 'report' it was a letter written to highlight issues and get the group’s membership excited about attending the session. It was not intended to be a document of record regarding the organization’s stance on CIRM.

“You did not check the facts in the letter. You could quickly tally the for-profit grants on our web site and see that the $45 million awarded to industry is 4.5 percent of the amount awarded not the 3 percent cited. But you know that even this number is not a good comparative number. Anyone who follows CIRM knows we are working from a 'pipeline' strategy moving from basic research and infrastructure to clinical application. Industry was not, and should not have been, eligible for the early rounds of grants. I do not believe the taxpayers wanted us building facilities for for-profit entities. Also companies would not have been appropriate recipients for our training grants. So, if you look at only research dollars, the pie shrinks to $628 million and industry’s share is 7 percent.

“However, that is still not an appropriate number to use. The first two research awards, the SEED and Comprehensive grants, were called the Jumpstart program designed to get this new field launched. They were issued before we had an intellectual property (IP) policy in place and therefore could not be offered to industry. (And don’t suggest we should have had an IP policy in place by then given the vast number of new systems the agency was developing simultaneously.) If you subtract those dollars the pie shrinks to $511 million and industry’s share rises to almost 9 percent.

“Given our pipeline strategy and our stated intent to start out more focused on basic science and move into the translational and clinical arenas when the science matured, this is a respectable percentage. As you well know we have a $50 million Targeted Clinical Development Request For Applications active now and that could double industry’s share in one grant round.

“If you look at the industry partnerships our academic grantees have formed, the dollar amount committed to industry is already probably double actual grant total. While only one disease team Principal Investigator was from industry, a second team had a co-PI from industry and another eight have major contracted relationships with industry.

“CIRM’s management team is certainly not biased against industry. Seven of 12 science officers came to us from industry, and there is frequent discussion in the office about ways to bring industry more firmly on board with our mission and to clear misconceptions on our policy.  This is the reason we developed a webinar on grant writing that is now on our website http://www.cirm.ca.gov/GrantWritingWebinar030310

“Also, a little fact checking would have revealed that the number of industry reviewers on our grants working group was wrong in the BayBio letter. Thirteen members are currently employed by industry and another 13 have strong ties to industry as former industry employees or having been involved in founding a company. So, that is 26 out of 136 reviewers, not the six suggested.

“Your posting did not represent the over all tone of the BayBio meeting. It was generally a very constructive session. One executive present noted that when our regulations were explained, his company was comfortable enough to apply.

“Distortions relying heavily on a single disgruntled source do not do a service for the stem cell field or help the reputation of the blogosphere.”

Full BayBio Report on Lack of CIRM Grants to Business

The California Stem Cell Report has offered the state's stem cell agency and its directors an opportunity to respond at length in connection with the biotech industry's concerns about the paucity of awards to business.

BayBio, which represents the industry in Northern California, documented the complaints in a six-page paper in August, just two months after CIRM Chairman Robert Klein dismissed a call by a non-industry source for action on the matter. The entire BayBio document can be found here. It was used to prepare industry executives for a closed-door meeting with Klein and other CIRM officials in August.

We have emailed directors and CIRM, asking them if they would like to respond. We promised that any comments would be carried verbatim, which is almost never done in the mainstream media.

We have also sent links to the items to the blue-ribbon panel of reviewers who will be conducting a sweeping review of CIRM next week. However, the public and industry have been barred from attending the closed-door sessions, with the exception of one-hour to make comments or ask questions. The public and industry will not be permitted to hear testimony from CIRM staff or other witnesses.

CIRM Directors to Consider $600,000 Online Journal Plan

Coming up in only three business days is a meeting of the Finance Subcommittee of the California stem cell agency, which is expected to act on a $600,000 proposal to create an online scientific journal and alter CIRM's fledgling loan program for biotech businesses.

No specifics are available, however, from CIRM's Web site, which makes it difficult for interested parties to comment thoughtfully. In fact, the agency's de facto policy of regularly withholding until the last minute details on proposals coming before its directors discourages the public from commenting.

Also on tap is “consideration” of projected cash flows for the agency in connection with its strategic plan, which is scheduled for a sweeping, two-day, closed-door review next week. It is unclear why the cash flow matter is coming before the directors' Finance Subcommittee since it would not appear to require action. It may be a discussion proposal to set the stage for creating a policy for future expenditures – such as spending the agency's cash more rapidly -- sooner rather than later.

Regarding the loan policy, the agenda for the Finance meeting said only that the program, which originally was touted as a $500 million effort, would be amended. No other clue was offered concerning the changes. CIRM has made only one, $20 million loan in the program.

The journal proposal is part of the CIRM budget that was approved last June. At the time, CIRM President Alan Trounson told directors,

“What we would like to do is create an interest in one of the journals to bring out a translational journal which was focused on stem cell translation and for them to do all of the independent editing and all the reviewing and so forth.”

He said it was needed to provide a forum for discussion of regulatory issues and publication of research with negative results. He said that currently “translational papers” are scattered and hard to find.

We later asked for more details from CIRM. Don Gibbons, CIRM's chief communications officers, sent along a draft of an RFP. The proposed RFP dates back to July 26 and may well change. But it says that raising unique translational issues to a higher priority in journals would accelerate the entire field.

The draft RFP called for a three-year subsidy of the online, open access publication and required a business plan that would demonstrate self-sustainibility at the end of that period.

During next Tuesday's meeting, the public can participate at teleconference locations in San Francisco, San Diego, Stanford, Irvine and La Jolla. Specific addresses can be found on the meeting agenda.

The Biotech Industry and the California Stem Cell Agency: An Unhappy Relationship

Late last June, the chairman of the California stem cell agency, Robert Klein, dismissed concerns that biotech firms are not getting a fair shake at the agency's $3 billion in research awards. That's not what he has heard, he told CIRM directors. In fact, Klein said, he had just received an award from a national industry group.

Two months later, leaders of the Northern California biotech industry sat down with Klein at private dinner at a tony San Francisco peninsula restaurant and told him that he was simply wrong.

They showed him the numbers. In the five years that CIRM has been operational, businesses have received only 3 percent of the more than $1 billion awarded so far. If CIRM really wants to produce therapies that can be used, Klein was told, it can only do so by helping to finance enterprises that actually create medical products.

One executive in attendance at the Aug. 25 dinner at the Marche restaurant in Menlo Park had harsh words for the agency. He later told the California Stem Cell Report that CIRM is “completely misaligned and mismanaged.” He said the agency is dominated by the academics on its board, whose institutions have received nearly all of the funding. The executive said the academic institutions are not going to deliver on CIRM's mission of “turning stem cells into cures.”

However, June's message of concern came from an unlikely, non-industry source. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., called for a major effort by CIRM to deal with the matter. The issues he addressed have been simmering for some time, largely in private because of CIRM's enormous funding clout. No one wants to be on the agency's bad side.

In a statement to CIRM directors, Simpson said,

“When Consumer Watchdog began its stem cell project almost five years ago, I naïvely expressed concerns that the program would be hijacked by the biotech industry. That has -- at least so far -- not happened; rather, it has been dominated by academic research institutions, whose representatives hold the largest number of seats on the board.”

He recommended that CIRM take a number of steps, including a public task force, to remedy the situation.

According to the meeting transcript, Klein replied in part,

“I don't think the biotech industry at large has feelings that are reflected in that statement. As some of you may know, I received a reward from biointernational conference (BIO) this year, their humanitarian award.”

The August meeting, however, that Klein attended included top executives from Geron, iPierian, Vistagen, StemCells, Inc., Cellerant and others. “All the major players,” we were told. The dinner was organized with the support of BayBio, the biotech industry organization in Northern California, and the Orrick law firm of San Francisco, which serves as bond counsel to the state of Californa. From CIRM came – in addition to Klein – Director Ted Love and Patricia Olson, the agency's executive director of scientific activities . Missing was CIRM President Alan Trounson. No reason was given for his absence.

A BayBio briefing paper for the meeting, said,

“CIRM has a perception of not being friendly to industry. Private companies with strong track records of receiving NIH funding are frequently unsuccessful in getting grant funding from CIRM. Conversely, in comparison to CIRM for-profit companies have sporadic success rate at best with CIRM grants. CIRM’s contention on this is that the non-profit applicants that are received they tend to come from well-established and research –intensive institutions, as opposed to the less known and established for-profit companies.”

The paper said,

“CIRM’s current grant review policies and practices do not track with the stated goals of RFAs and favor funding academic applications thus reducing funding opportunities for industry and discouraging future company participation.”

CIRM's leadership, including Klein, also came under criticism for a lack of understanding about what is needed bring a stem cell therapy to the clinic. “Everybody is enamored of Klein,” said the source at the meeting. The deans on the board have no knowledge of product development, he continued.

CIRM directors are not unaware of business concerns, but the situation has remained nearly unchanged over the years. Only on rare occasions has a biotech executive publicly voiced concern. One of the issues that has been raised involves the lack of grant reviewers with business backgrounds, a situation that has existed since CIRM's inception. Directors have discussed the need for improvement. Some  have said there is tilt towards basic science among reviewers that manifests itself in a lack of interest in the relatively more pedestrian research needed to produce a product.

The BayBio paper said,

“Currently there are no scientific experts from industry on the grants review group and only six (out of 89) are alternates.”

The briefing paper made three recommendations:

“BayBio and industry need clarification on CIRM IP and public access requirements to increase private sector comfort with CIRM programs and encourage more companies to participate in the program.
“Changes are needed to the grants application and approval process to increase the success rate of companies applying for CIRM funding.
“There needs to be more transparency all around with respect to the process and final decision making.”

The CIRM officials took notes on the August discussion and said they would get back to the participants.

Next week, the stem cell agency will hold a two-day, closed-door review – with the exception of one hour -- of its strategic plan. The “external review” is the most comprehensive examination ever of CIRM's direction. However, the fair treatment of business grant applications is not one of the specific subjects listed on the agenda for the blue-ribbon, international panel.

California Stem Cell Report Honored as One of The Best Stem Cell Blogs

The California Stem Cell Report has been named one of the top 13 stem cell blogs internationally by Webicina.com, a physician-directed Web site aimed at helping physicians and patients obtain reliable information.

Webicina prepared the list because of the plethora of misleading and inaccurate information on the Web. In addition to this blog, the list of best blogs included the Cancer Stem Cell News, authored by Jim Till from the Cancer Stem Cell Consortium in Canada, CellNEWS, authored by Lars Carlsson, a Swedish researcher, and Stem Cell Awareness of the Stem Cell Cell Awareness Association.

Webicina is directed by Dr. Bertalan Mesko from Hungary, who is also responsible for the ScienceRoll blog, which he reports has had more than 1.6 million views. Mesko has also been quoted by Nature, the New York Times and the British Medical Journal, among others, concerning the impact of the Web on science and medicine.

Candidates Sought for Board of California Stem Cell Agency

Want to join a small brigade of public servants working on the cutting edge of science and public policy? Looking to take part in giving away $2 billion? Here's your chance.

California's top fiscal officer, Controller John Chiang, is seeking nominations for five openings on the 29-member board of directors for the $3 billion California stem cell, which has already awarded $1 billion to a total of more than 300 recipients.

You can nominate yourself or others. But there are some legal requirements. For example, nominees for chairman of the CIRM board should have “a demonstrated history in successful stem cell research advocacy” and “experience with state and federal legislative processes that must include some experience with medical legislative approvals or standards and/or funding.”

In addition to nominating candidates for chairman and vice chairman of CIRM, Chiang is looking for candidates for three other slots on the board. The positions, which have six-year terms, also have special requirements. One, for example, must come from a California life science business. Prop. 71 did not provide for a general representative from the public.

Chiang's Web site also said,

“The controller has been a leader in promoting public and private sector board diversity and is interested in finding qualified nominees and appointments who reflect the diversity of California.”

The jobs are important, require a fair amount of work and do not pay well, except for the chairman and vice chairman positions, which also involve a great deal more work than regular board positions. The chairman and vice chairman positions carry salaries. The others do not, only a modest per diem.

Other statewide officials, including the governor, lieutenant governor and state treasurer, make nominations for positions on the CIRM board. So interested parties have more than one shot. However, none of the other officials has posted a public appeal on their Web sites. We are sure, however, they are open to suggestions from the public.

The deadline for submitting nominations to Chiang is Oct. 15. Successful applicants could begin work in December.

Public and Scientists Left in Lurch on Proposals Affecting $2 Billion in Taxpayer Funds

A key panel of directors of the California stem cell agency met late last month to consider changes in its grant procedures that will affect hundreds if not thousands of scientists in California to the tune of $2 billion.

The Science Subcommittee discussed the proposals at a session on Sept. 29. However, the public and the affected parties had little clue in advance about the specifics of what was to be considered.

The agency withheld the details of the proposals until a mere two days before the meeting, effectively preventing the public from making any thoughtful comment, even if they knew the documents had been posted on the CIRM Web site. CIRM does not make an effort through its Web site to let the public know when important information has been added to meeting agendas. Its general practice is to wait until a day or two before a meeting to post any significant information concerning matters to be considered by its directors.

The proposals before the subcommittee or variations may come up again at another meeting of the panel or possibly the CIRM board of directors.

Here are links to the documents that were posted no earlier than Sept. 27 and Sept. 28. They deal with appeals processes on grant applications, scoring of grants and a triage process on grant proposals prior to their formal legal review.
"Extraordinary Petition Process Option A / Posting Applications"

"Extraordinary Petition Process Option B / Additional Analysis"

"Extraordinary Petition Process Option C / Limited Investigation"

"Discussion of proposal for programmatic scoring of grant applications by Patient Advocate members of Grants Working Group for inclusion in discussions and decisions regarding applications."

 "Discussion of Pre-Application Process, including but not limited to the process generally and scientific feedback to applicants who are not successful in the process."

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.

Credibility Damaged and Foes Aided: No Upside on CIRM's Ban on the Public

The California stem cell agency's ban on the public during the most sweeping review ever of its operations promises little upside for the $3 billion enterprise and plenty of downside.

That's not to mention the fact that the ban is poor policy and is not likely to achieve its stated purpose – candor from those testifying before the blue-ribbon, international panel that has scheduled three days of hearings in San Francisco beginning Oct. 13.

The “external” review, as CIRM has labelled it, is called for by the agency's strategic plan of 2006. That document recognized the need to revise the plan as conditions changed. It was prepared with substantial comments from the public and a number of open hearings,

CIRM has devoted about 2,000 hours of staff time preparing for the the latest review, which will be critical in determing how the agency will spend its remaining $2 billion. The eight-member panel, which includes a Nobel laureate, is expected to prepare a report that will be considered by the CIRM board in December.

The strategic review comes as CIRM Chairman Robert Klein is publicly discussing presenting to voters a $5 billion bond measure to continue CIRM's activities. A bond measure is necessary because the agency's only real source of funding is cash that the state borrows (bonds). Klein's new bond proposal places the agency's efforts squarely in the context of a political campaign, which could come as early as two years from now.

Last week CIRM told the California Stem Cell Report that members of the public would be barred from attending the agency's external review. CIRM also has made no public effort to solicit comment from California citizenry, which is paying $6 billion, including interest, for the research program. Nor has CIRM notified the public via its Web site that an important evaluation of CIRM will take place.

Don Gibbons, spokesman for CIRM, said the closed-door sessions were necessary so that “reviewers can ask tough questions and receive candid, unfiltered responses” from CIRM staff, biotech executives and some CIRM board members who are scheduled to appear before the review panel.

The reality, however, is much different. CIRM staffers who want to keep their jobs are not going to say anything to reviewers that they haven't already told their superiors. Biotech executives who want to receive grants or loans from CIRM are unlikely to be sharply critical of the agency. And CIRM board members are more than likely to be circumspect, given that they have to make the final judgment on whatever the panel comes up with.

Only a “small number” of the 29 board members have been invited to make comments to the panel. Their identities and topics are yet to be disclosed.

The closed-door proceedings pose a problem for any CIRM board members who might want to sit in on a session or two. Essentially, they must ask permission of the CIRM staff to attend. That's because if too many of them attend, they could run afoul of the state's open meeting law by either constituting a quorum or creating what is known as a “serial meeting.”

Board members have sometimes complained about having to act with too little information. The primary example is appeals on grant applications. The board has repeatedly been asked to overturn negative decisions by grant reviewers, but cannot actually examine the actual applications. In January 2009, the board was caught by surprise when its bond funding was endangered. That particular problem was in evidence to knowledgeable persons well prior to that meeting and could have been disclosed to the board earlier. Limiting directors' attendance at the external review distances the board even more from key aspects of CIRM operations.

Last week we polled CIRM directors about whether they thought that the external review should be open. While we can't say our email reached all directors, we believe most saw it. Four responded. Only one director, Jeff Sheehy, said yes. Others may feel likewise while some are opposed, but at the same time feel constrained about responding via our query.

Director Floyd Bloom, former editor of Science magazine, said he did not see a need for the public to able to attend the review, He said the panel's report will be considered later by CIRM directors, and the public could comment then. (You can read all of the results here of the query including comments from some directors.)

CIRM has yet to provide a legal justification for closing the review. However, little doubt exists that the agency believes the ban on the public is lawful. Presumably CIRM would make a similar argument to one presented last July in connection with another CIRM meeting that barred the public.

However, those arguments fail to take into account a major change in the state Constitution in 2004 that guaranteed the public a broadly construed right to access to governmental affairs. The state's open meeting laws were written before that change and have not yet been amended to reflect its broader constitutional access provisions.

From a political and good government perspective, the ban on the public, coupled with continuing complaints about a lack of transparency at CIRM, unnecessarily provide major ammunition to its foes along with the foes of hESC research across the nation. Closed-door proceedings breed suspicion, even on the part of a public inclined to support stem cell research. They provide a fertile ground for the worst sort of rumors and add evidence that CIRM is an “insiders club,” as others, including Nature magazine, have complained. No doubt exists that Klein's $5 billion bond measure campaign will have to confront severe criticism about the lack of openness at CIRM.

One reader of this report, who is knowledgeable about CIRM affairs but who must remain anonymous, told us,

“The failure to provide any opportunity for public input in the process diminishes its credibility and utility. This is a hand-picked body following a pre-determined agenda that was defined  by CIRM. CIRM (i.e. Klein) decides what's presented and what's considered. The outcome is predictable.”

CIRM carries a special burden in connection with openness and transparency because of its unprecedented nature. As opposed to other state departments, it is not subject to normal oversight by the governor and the legislature. Funds flow to it unaffected by the financial crisis that is damaging public education and medical assistance to the poor in California.

Gov. Arnold Schwarzenegger has been advocate of more openness throughout state government and also a strong supporter of CIRM's operations. He has opened up other state departments' activities, including executives expense accounts, to public scrutiny. He said some time ago,

“Transparency is fundamental to promoting efficiency and effectiveness in government and strengthening the democratic process by giving citizens enough information to reach their own conclusions about how their tax dollars are being spent.”

CIRM should reconsider its position and open the external review to the persons who are actually financing its operations.