Links to CIRM Grant Review Process

Here are some links to documents relating to the California stem cell agency and complaints about fairness in its grant review process.

Consumer Watchdog Identifies Businesses Rejected for CIRM Grants

CIRM's August Proposal for a Reconsideration Procedure (this is likely to be modified for CIRM's September meeting)

Transcript of August CIRM Meeting

Cascade LifeSciences Seeks Reconsideration

Text of Cascade's Reconsideration Letter

CIRM Response to Cascade

Transcript of June CIRM Meeting Involving Cascade

Transcript of the January CIRM directors meeting, which heard the first public appeal of a scientific review. Search on the term "luben," which is the misspelling of the name of Bertram Lubin, president of Childrens Hospital Oakland Research Institute, who appeared before the directors seeking reconsideration.

Nature magazine article April 30, 2008, in which Lubin comments on CIRM

California Stem Cell Report account of part of the January meeting involving the Lubin appeal.

Advocate Reed Says No Need for Independent Look at CIRM

On Sept. 5, 2008, we carried an item dealing with a proposal for an examination of the California Institute for Regenerative Medicine by a bipartisan state department charged with improving government operations.

We said that corporations pay hundreds of thousands of dollars or more for independent assessments of their operations and that CIRM should welcome the opportunity to have a similar study performed for free. The springboard for our comments was an item written by patient advocate Don Reed on his blog, stemcellbattles.com. Reed has responded to our item. Here is what he sent us.

"Several days ago David Jensen printed a thoughtful article inquiring why I was encouraging people to write to Governor Arnold Schwarzenegger ( State Capitol Building, Sacramento, CA 95814), urging him to veto Senate Bill 1565.
 
"The reason is simple. If people like our stem cell program as it is (I do), they should defend it. The Governor will be deciding in the next few days whether to accept SB 1565, or veto it.  This is the only chance we have of preventing SB 1565 from becoming law.
 
"SB 1565 could completely restructure California’s stem cell research program, as well as removing our state’s official preference for embryonic stem cell research.
 
"The article criticized advocates like myself who are allegedly “blind to blemishes… (and who) regard any evaluation or analysis of the effort as destructive.”
 
"I don't see it that way. As someone who attends and participates in most of the meetings of the stem cell program, I see a constant and vigorous process of adjustment and correction.  The CIRM has had (by my count) four in-depth official audits; the California Court system has examined our (California’s) structure.  Evaluation and analysis is ongoing, and the public is involved in every step of the way. That’s good; it’s democratic; it’s necessary.
 
"What I do object to is throwing out something magnificent after the decision has been made.  California fought for our stem cell program, debated over it, and voted.
 
"Why did we have to use the initiative process?
 
"Practicality!
 
"I fought for three years trying to pass the Roman Reed Spinal Cord Injury Research Act—and California ended up with only $1.5 million a year for that program. It is a good program, spending $12 million, but bringing in more than $50 million dollars in matching grants, new money for the economy—but it is so little, compared to the need.
 
"As a grass roots organizer I helped with Senator Deborah Ortiz’s groundbreaking legislation. She did a terrific job, gaining permission for the (then) controversial new medical procedure. To me, she will always be the Mother of California stem cell research. But those bills came with no money. It took a real fight to get a lousy hundred thousand bucks to run a committee, and no research money whatsoever.
 
"I remember a group of advocates meeting with Senator Barbara Boxer, a true friend of research, and she told us: “What you need is billions of dollars, and we can’t get that for you in Sacramento.” 
 
"So Sacramento couldn’t raise the money to fund the research. Washington dropped the ball for political reasons.
 
"But California came through.
 
"Embryonic stem cell research offers hope for cure not only for my paralyzed son, but also for Sarah Palin’s boy who has Down’s Syndrome, and for millions more who suffer with incurable illness or injury.  
 
"SB 1565 would remove California’s official preference for embryonic stem cell research, which was the reason we passed the program in the first place. Unfortunately the new Republican platform calls a complete ban on embryonic stem cell research, both public and private, criminalizing it completely. SB 1565 is co-authored by Senator George Runner, a long-time opponent of embryonic stem cell research, and if that bill passes, it could provide ammunition to the opponents of the research.
 
"And the program itself? The California structure--with decisions made by patient advocates and experts-- was designed specifically to keep the focus on the quest for cure. No one wanted it to become a self-serving bureaucracy, rambling around in search of reasons to justify its existence, making endless speeches and not actually doing a lot.
 
"We wanted intelligent action, and we got it.
 
"So of course we are going to defend it. Can someone point me to a better program, anywhere in the world?
 
"If so, let me know. In the meantime, I think we should protect what we won.
 
"Anybody that cares about stem cell research should write Governor Schwarzenegger today. (tip: on the outside of the envelope, put VETO S.B. 1565, that helps them."

Biotech Loan Proposal: Questions About Affordable Access

The proposal to create a massive biotech lending program – funded by the state of California – came under additional scrutiny at last month's meeting of the board of directors of the state's stem cell agency.

One director and an outside observer raised questions about the strength of the commitment to provide affordable access to any therapies resulting from the program, which could run $500 million or so. That figure and larger ones have been voiced by CIRM Chairman Robert Klein, who originated the loan plan concept. However, directors have yet to determine actual size of the program.. Klein also in August mentioned loans as large as $30 million but again directors have not yet set loan size ranges.

Those issues could likely come up at Saturday's meeting of the CIRM Finance Subcommittee.

In August, CIRM Director Duane Roth, chairman of the Biotech Loan Task Force, reviewed the program for his fellow directors, According to the transcript, he said the loans will target "funding gaps " where "there's virtually no alternative capital available to invest."

Roth, chairman and CEO of Alliance Pharmaceutical Corp., said,

"These are very, very open terms that no bank or no venture capitalist would offer....But that's part of fulfilling our mission, to fund those things that are very difficult and make it easy."

CIRM Director Jeff Sheehy, a communications director at UC San Francisco, raised questions about the strength of the "covenants" in the biotech proposal to provide affordable access to therapies.

He said,

"These are reasonable things to ask from industry if they're going to get our money."

Other directors, including Vice Chairman Ed Penhoet, assured Sheehy the commitment is genuine.

Penhoet, co-founder of Chiron, said the "covenants are real." He added,

"I certainly don't take what's in front of us here in the loan policy as (something) we're soft on."

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., also raised a cautionary note, based on CIRM letters to the Legislature concerning a measure (SB1565) aimed at ensuring affordable access. He noted that CIRM has repeatedly referred to the need for "flexibility" in requiring affordable access.

He said,

"The plea for flexibility comes across to me as, well, when push comes to shove, we're going to cave and give in to biotech."

Biotech Loan Information

Here are some links to information related to the CIRM biotech loan proposal.

Transcript of the Aug. 13, 2008, meeting of the CIRM board of directors.

Biotech loan policy document for Aug. 13, 2008, directors meeting.

Biotech terms and policy May 6, 2008, version

PriceWaterhouseCoopers report-(three parts)
Benchmarking analysis
Loan financial model
Loan model scenarios

Transcripts of the Biotech Loan Task Force

Transcript of Finance Subcommittee June 19, 2008, which dealt with size of loans and possible conflicts of interest

Agendas of the Biotech Loan Task Force
The agendas have links to additional documents dealing with the plan.

A Theatrical Trounson Appearance in San Francisco

"A sharp and generous comedy, for our times, on roller skates," it's been called. So what does it have to do with the $3 billion California stem cell agency.

The answer: The author of the play is Kylie Trounson(see photo), daughter of Alan Trounson, who presides over the Golden State's research effort.

The play, "The Man with the September Face," will premiere in the United States at the Boxcar Playhouse in San Francisco for one night Friday at 7 p.m. A reception will follow the staged reading.

One Australian writer said this about the play,

"The decadent but vacuous nature of the Eighties aesthetic is a rich platform for investigating our existential artist, Jesse, languishing in a suburban intellectual and political wasteland. In synch with the Berlin Wall, he finally crumbles. "

Kylie Trounson is a playwright, actor and teaches drama and acting.

If I were a CIRM staffer, I would be sure to attend this event. It would be the politic thing to do.

Biotech Loan Plan Up Again on Saturday

Followers of the biotech loan proposal from the California stem cell agency will have a another chance later this week to make suggestions and hear the latest permutations in the $500 million or so effort.

The CIRM directors' Finance Subcommittee canceled last week's hearing and rescheduled it for this Saturday. The agenda remains the same as we discussed earlier. And there is still no further explanation of the cryptic topics on the agenda.

As we mentioned previously, if you have something at stake in biotech loan program, now is the time to weigh in. It is likely to come up later this month at the directors' meeting, but that is a less propitious venue for making an impact. Teleconference locations are available in Northern and Southern California.

Whale Shark Nursery

The California Stem Cell Report is now being produced from Bahia de Los Angeles, a lovely, large bay in Baja California on the Sea of Cortez. The area is remote. It only gained regular electricity last year. Previously the village of perhaps 800 persons received electrical power from a huge, throbbing diesel generator that was shut off every night at 10. The town then went completely dark. Satellite phone and Internet service came in several years ago as a result of a special Mexican government program to help isolated communities. Cellular service does not exist. Currently the only Internet link – a rather slow one -- is via an Internet cafe, which requires a dinghy ride to shore and a one-mile walk in 100 degree heat.

As for those whale sharks, during this time of year, juvenile whale sharks swim slowly on the surface of the water in the southern part of the bay, feeding on creatures that they filter through their huge mouths. About 25-feet long, they are oblivious to people and boats and have no known natural enemies. As the water cools, the youngsters leave the bay and migrate to parts unknown where they reportedly grow to 50 feet or more.

Doing the Public's Business in Public

Consumer Watchdog's John Simpson usually spends his days tracking events at the California stem cell agency, but recently he attended a meeting of the Interstate Alliance on Stem Cell Research.

That group is even less well known than CIRM, which sometimes worries that its name does not tell the full story of a $3 billion California human embryonic stem cell research effort.(see item below)

The IASCR, as the alliance is known, indirectly grew out of Prop. 71, the ballot measure that created CIRM in 2004. The research effort in California spawned similar ones by other states, raising concerns about scientific and bureaucratic chaos in research standards.

Thinkers at the National Academy of Sciences and elsewhere decided that something must be done to keep everybody on sort of the same track. Otherwise research would be impaired. Thus the IASCR came about.

Earlier this week, Simpson participated in two days of meetings by the IASCR in Baltimore and reports that the meeting seemed to be a success. The group decided to develop a model form for states to use in helping to certify that stem cells have been ethically derived.

Simpson writes on his organization's blog that it was a good decision, one that was debated and decided in public. That is significant since Simpson a couple of years ago was kicked out of a meeting of the group in Irvine, Ca., despite an earlier invitation to attend.

The current openness of the IASCR is healthy, Simpson writes, and adds credibility to the organization and the entire stem cell research effort. We agree.

The CIRM Name Game; USC Goes First

The University of Southern California has become the first California institution to break ground on a stem cell research facility that is partially financed with some of the state's $3 billion in stem cell research funds.

Rattling around in the background is an extremely low profile discussion of naming protocols for structures financed by CIRM, including a comment from one CIRM director that she hates the term CIRM.

In case you missed the USC event, it occurred Sept. 4 with considerable institutional ballyhoo, but also some media coverage. The Los Angeles Times, which rarely writes about CIRM affairs despite being the largest newspaper in the state, recorded the ceremonies along with some television coverage, based on what can be found at the USC web site.

CIRM Chairman Robert Klein and CIRM President Alan Trounson were on hand (see USC photo above with Klein in tan suit and Trounson on far right) to heft two finely polished shovels. But the man of the hour was Eli Broad (the white-haired man next to the woman), whose foundation popped for $30 million for the facility, which will cost a total of $80 million. California taxpayers, via CIRM, added $27 million. USC said the remainder will come from other individuals and foundations.

The 80,000-square-foot structure will be formally called the Eli and Edythe Broad CIRM Center for Regenerative Medicine and Stem Cell Research, but it is impossible to tell right now how it will be referred to on a regular basis by its users.

CIRM has more than a casual interest in the naming of buildings it helps to finance. The stem cell agency requires that institutions secure the agency's approval. Don Gibbons, chief communications officer, told CIRM directors that the USC name will not be official until the directors approve it at their meeting later this month. The naming protocol is also of substantial interest to the institutions that want to recognize individuals or foundations that make hefty contributions, including ones that exceed CIRM funding.

Last month, Gibbons discussed the phrasing used by USC and also language proposed by UC Davis. UCD plans to use "California Institute for Regenerative Medicine" as a subscript on the name of its stem cell research lab.

On a straw vote last month, directors indicated that they favored both methods, but not before a brief discussion of whether CIRM is a "very good brand" or whether the "California Institute for Regenerative Medicine" is better. The question seemed to revolve around whether the public would understand that both names indicated that cash came from the California stem cell agency.

CIRM Director Joan Samuelson said the CIRM abbreviation had bothered her for a long time.She said,

"I hate the brand CIRM...It sounds like sperm."

She said CIRM "means absolutely nothing to the public," which is financing the stem cell effort.

"CIRM just doesn't mean anything," Samuelson said, suggesting it would be "lovely" to name buildings after people who are suffering.

Our take: The public does not know what CIRM is, nor does it know what the California Institute for Regenerative Medicine is. High profile public recognition is not likely to occur short of a huge scandal or an incredible research breakthrough. The difficulty with both expressions is that neither says stem cell research. That is the main reason we initially refer in our items to the California stem cell agency. No confusion there.

Neptune's Follies

The California Stem Cell Report will be dark for a week or so as we begin another multi-day ocean passage in the Sea of Cortez. However, rather than sailing/motoring for 78 consecutive hours as we did previously, we will be dropping the hook overnight at remote anchorages along the eastern shore of Baja California. We have been requested by one reader to post a photo of our current location, which is in the mining town of Santa Rosalia. The image is of the 9-boat marina, which has seen better days. The docks feel like trampolines. Cockroaches play in the marina shower, scampering across your feet. The temperature is 100 degrees, and no air conditioning exists in our sailboat, which is located in the foreground with two black masts. The small outboard boats, also in the foreground, are used by workers at night to fish for squid, which they sell to a processing plant owned by the Moonies of South Korea.

CIRM Announces $60 Million Translational Grant Round

The California stem cell agency this week posted its request for applications for a $60 million grant round dubbed the Early Translational Research Awards.

CIRM is proposing to split $60 million among 10 recipients, who are required to make a three-year effort.

CIRM said the awards, which are open to both business and nonprofits, "are designed to move promising basic research in stem cell science toward the clinic."

It said,

"These awards will support two categories of projects including research that:  1) results in a development candidate that meets an unmet medical need; or 2) addresses a significant bottleneck in the translation of stem cell biology that hinders advancement of effective, novel cell therapies to the clinic."

Letters of intent are required by Oct. 15, applications Nov. 20. Funding may come in the summer of 2009.

Fresh Comment

Larry Ebert has posted a comment on the "Outside Look" item.

A Partial Case for a Deep Outside Look at CIRM

California patient advocate Don Reed has embarked on a letter-writing campaign to have the governor of the state veto legislation aimed at ensuring affordable access to taxpayer-financed stem cell therapies.

Of course, Reed, a longtime and effective advocate for stem cell research, does not see the legislation that way. In an appeal on his blog to the patient advocate community, he warns that SB1565 "intends to restructure" the board of directors of the $3 billion California stem cell research effort. With all due respect to Reed, he has overstated the case in a way that does not necessarily well-serve the best interests of the California Institute for Regenerative Medicine.

His assertion is based on the measure's request for a study of CIRM by the state's bipartisan Little Hoover Commission. Even if the commission performs the study and recommends structural changes, their enactment is remote. They would have surmount a huge barrier, including possible alterations in the state Constitution. That would require a two-thirds vote in both house of the legislature and a vote of the people.

Reed's latest outpouring against the legislation embodies in some ways the deep-seated concerns among some stem cell advocates that somehow CIRM could be thwarted. Many supporters of the state research effort are wary of any public scrutiny of the agency. They are blind to blemishes. They regard any evaluation or analysis of the effort as destructive. The true believers also sometimes seem to be bent on funding hESC research regardless of whether the state of California benefits significantly from the expenditure of $6 billion in public funds, including interest.

Prop. 71 created the California Institute for Regenerative Medicine. The ballot measure was not hammered out in a public process. It was written behind closed doors with no public input. It was put before the people because someone ponied up $1 million-plus to gather the necessary signatures to place it on the ballot. The initiative placed representatives of the beneficiaries of the $3 billion in grants in control of the rules for giving away the money, a built-in conflict-of-interest that naturally raises concerns. Prop. 71 also created difficulties that have repeatedly hampered CIRM's operations, including an unusual quorum arrangement that forced directors last month to fill out their panel by picking a member from the audience. All of which is legal under Prop. 71. And then there is the dual executive arrangement that helped to create unhealthy management tension early on.

All public agencies need and deserve outside scrutiny. It is one of the basic principles of American government and is embodied in the concept of checks and balances amid the three branches of government. CIRM operates largely without those checks. For all practical purposes, it is free from fiddling by the executive or legislative branches of California government.

CIRM is an extraordinary experiment, unprecedented in California history. Some believe it could serve as a model for successfully tackling other difficult social problems. It is important that it be successful, fulfilling its mission efficiently and in a manner that recognizes its first responsibility is to the public – not the scientific community, not patient advocates and not industry. They are all exceedingly important constituencies, but CIRM is first a public endeavor. If CIRM is perceived to be under the control of those groups, its credibility will be damaged. Public trust can be mercurial. It can easily vanish overnight, and the whole field of hESC research can become besmirched.

Corporations regularly pay hundreds of thousands of dollars – if not millions – to outside consultants to analyze and critique their operations as they strive to remain efficient and competitive. The Little Hoover Commission will basically do the same job for free for the California Institute for Regenerative Medicine. CIRM should welcome the commission and use the opportunity to build support for making some of the difficult changes that could make it more successful in its mission.

Big Money Issues Come Up Next Week at CIRM

A key panel of directors of the California stem cell agency next week will tackle three hefty financial topics, ranging from its proposed $500 million biotech loan program to the amount of money available for grants and loans.

No details of what is to be considered are yet available on the CIRM website for the Sept. 12 meeting of the Finance Subcommittee. But here is the text of the three items to be considered: "Consideration of portfolio policies for CIRM Loan Program," "Consideration of business review processes for CIRM Loan Program" and "Informational presentation on CIRM program budget and funds available for research grants and loans."

The meeting will take place at CIRM headquarters in San Francisco with teleconference locations in Menlo Park, La Jolla, Irvine and Berkeley.

If you have any interest in the biotech loan program, this is a meeting that you should attend at any of the locations(addresses on the agenda). Comments and suggestions can be made at the teleconference locations. If you have specific recommendations, send a letter as soon as possible to CIRM, explaining them and their rationale in detail.

The latest discussion of the biotech loan program can be found in the transcript of the August directors meeting.

California Lawmakers Make Stem Cell History

Another first has been scored in the brief history of California's unique and unprecedented, $3 billion stem cell research effort.

For the first time, California lawmakers have passed legislation that would affect the California Institute of Regenerative Medicine, a tiny state agency that functions largely outside of the control of both the governor and the state Legislature. CIRM was deliberately created that way through an initiative measure passed by voters in 2004. No lawmakers or other elected officials had a say in its contents.

The complex proposal, Prop. 71, set an extremely high bar against tinkering in its operations by the legislature. The ballot measure required a 70 percent vote of both houses to pass legislation that would affect CIRM – a super, supermajority vote that does not exist for any other bill. Even the state budget requires only a two-thirds vote. That hurdle has been so difficult to clear that California is now deadlocked in a record-setting, two-month long budget crisis.

Nonetheless, lawmakers last week sent to Gov. Arnold Schwarzenegger a bill – SB1565 – by Sens. Sheila Kuehl(see photo), D-Santa Monica, and George Runner, R-Antelope Valley, designed to ensure affordable access to stem cell therapies developed as a result of state funding. The bill was opposed by CIRM, industry and some patient advocates. They complained about its lack of flexibility, economic impediments and a change that would make it easier to fund research that was not based on human embryonic stem cells.

Kuehl said the bill is needed because Prop. 71 "lacks any provisions" to ensure that poor and uninsured Californians will be able to receive state-funded therapies at "the best available prices." She is joined by a raft of supporters included health access groups, retired persons, nurses and others.

The governor has until Sept. 30 to act on the bill. Otherwise it will go into effect without his signature. He could veto it. An override of the veto would seem remote even though the bill passed overwhelmingly. No negative votes were recorded until the measure hit the Assembly and then only a handful. It finally went to the governor after the Senate on Aug. 29 concurred, 37-1, in Assembly amendments.

Schwarzenegger has been a good friend of the stem cell agency and has garnered considerable favorable publicity touting it as a model for a way to get things done. Our bet is that he will veto the bill, but we could be wrong.

(Editor's note: The governor has pledged to veto any bill that comes his way until the budget crisis is resolved. However, he has breached that promise several times already. But his pledge could be good political cover for a veto if he chooses to use it. That also assumes no budget will be in place by Sept. 30.)

The Hunt for Stem Cell Gold

The California stem cell agency next week will provide tips to scientists and others prospecting for some of the $3 billion in research funding that the state is handing out.

Two days of briefings are planned – one in San Francisco on Sept. 11 and the other in San Diego on Sept. 12.

The sessions are targeted at private businesses but are likely to be useful for academicians as well. CIRM says it will "discuss ways to increase chances of successfully submitting a grant to CIRM." It will also discuss the agency's intellectual property regulations and explain them for private sector attorneys, executives and scientists.

These are must-attend meetings if you want to be serious about securing a CIRM grant.

Fresh Comment

Alice Wexler has posted a comment on the "CIRM Hopes" item.

Hook Down

Well not exactly. The anchor is still in its roller, but we have come to rest in a rickety marina about midway up the Sea of Cortez in a community called Santa Rosalia. The town has some fame as the site of an iron church reportedly designed by Gustave Eiffel of Eiffel Tower fame. It was constructed for an exposition in France in the 1880s and then dismantled and ultimately shipped to Baja California, where a French company was conducting copper mining operations. Some skeptics contend that the church may not have been designed by Eiffel, but those folks dare not show their face here.

We will be posting some fresh stuff on California stem cell matters after we work our way through nearly 150 emails and other related news.

Hoisting Anchor

As many of you know, the California Stem Cell Report is produced from a sailboat that cruises the west coast of Mexico. Sometimes, such as today, we actually get to sail. We are departing Mazatlan for a multi-day passage north into the Sea of Cortez. Until we reach our next port, we will not have any further posts. Look for some fresh stuff in about a week or so. We would like to be more definite, but sailing is a pursuit that depends on many conditions totally out of our control.

Fallout From Disclosure of the CIRM 18

Alan Trounson, president of the California stem cell agency, has sent a letter concerning disclosure of the names of 18 companies who expressed an interest in applying for grants from the $3 billion research program.

Trounson wrote the letter to the companies after Consumer Watchdog revealed the names that CIRM had attempted to keep confidential as part of its pseudo policy of secrecy. Pseudo because CIRM chooses to keep some names secret and reveal others. And many of its public grant review summaries contain enough information that any reasonably well-informed person can determine the identity of the applicant should he or she want to make the effort.

In his letter, Trounson expressed regret about the disclosure and said that CIRM has issued a "reminder" concerning its confidentiality policies.

John M. Simpson, stem cell project director for Consumer Watchdog, published a copy of Trounson's letter on Tuesday. Simpson commented:

"From what I've heard, representatives of companies on the list are talking with each other about why it was only one of the 18 companies, Novocell, received an award. They're comparing notes about the grant review process and how they feel it was biased against for-profit entities.

"There's a good chance they will work together as a group and take their concerns to the stem cell oversight committee, possibly as early as its September meeting.

"See what happens when a little light shines in?"