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?"

SB1565: CIRM Hopes Now Rest with Arnold

The California stem cell agency will be looking to Gov. Arnold Schwarzenegger to gallop to its rescue and veto legislation aimed at ensuring affordable access to state-financed stem cell therapies.

The bill cleared the Assembly on Monday, 64-7, and now is only one step away from hitting the governor's desk. It will only take Senate concurrence in Assembly amendments to send the measure, SB1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, to the governor.

So far the governor has not taken a position on the legislation, although he has been a friend indeed to the stem cell research program. A couple of years ago when CIRM was in financial straits, he loaned it $150 million, which has since been repaid with the state bond funds that finance CIRM's efforts. On more than one occasion, he has cited CIRM as evidence of doing good, both economically and scientifically.

CIRM and industry groups object to Kuehl's bill because it would lock into state law requirements that the agency contends would hamstring it in connection with negotiations with biotech companies. CIRM also objects to a provision that would lower a barrier to the funding of non-embryonic stem cell research.

Reporter Ron Leuty of the San Francisco Business Times wrote about the provision last month, noting that it was inserted at the request of the conservative Runner, who opposes to human embryonic stem cell research.

Leuty quoted Jeff Sheehy, a member of the CIRM board of directors, as saying,

"We may be handing a political victory to people opposed to human embryonic stem cell research that hasn’t been earned and that isn’t supported by the science."

The issue, however, is of little notice in the Capitol, where lawmakers and the governor are embroiled in a nearly two-month stalemate that has become the California budget crisis. The governor has ordered the layoff of 10,000 state employees and seeks to cut the pay of 200,000 state employees to the federal minimum hourly wage of $6.55 until a budget is passed. The spending measure is being blocked by Republicans, who can do so because it requires a two-thirds vote.

One could speculate that the CIRM legislation could get caught in that battle. Schwarzenegger needs some Republican votes for a budget. Perhaps he could generate a couple by signing the legislation, arguing that he is acting to support stem cell research that does not destroy human life.

The possibility may be remote but stranger things have been done under the dome. And lawmakers and the governor are desperate to find a solution to the budget crisis.

Fresh Comment

"Anonymous" has posted a comment on the "CIRM Bans California Stem Cell Report" item.

Consumer Watchdog: Some CIRM Directors Missing Work and Should Resign

Five directors of the $3 billion California stem cell agency have missed 60 percent or more of its board meetings this year, the Consumer Watchdog group reported today, declaring that there is "no excuse for flagrant absenteeism."

John M. Simpson, stem cell project director for the Santa Monica, Ca., group, said directors who cannot attend meetings should resign.

Simpson disclosed the attendance performance in a news release after doing an analysis of meeting records since 2006 of the board of directors, which is known as the ICOC.

Here is key paragraph on this year's attendance, which includes names, affiliation and designated slot occupied on the board.

"The worst attendance records for the five meetings this year, according to ICOC minutes, are: Marsha Chandler, executive vice president and chief operating officer, Salk Institute, an executive from a California Research Institute (20 percent); Jonathan Shestack, founder & vice president, Cure Autism Now, patient advocate mental health (20 percent); Tina S. Nova, president and CEO of Genoptix, executive officer of a commercial life science entity (40 percent) and Marcy Feit, president and CEO Valley Care Health Systems, patient advocate Type II Diabetes, (40 percent)."

Also absent from 100 percent of meetings this year is John Reed of the Burnham Institute, who has recused himself during a state investigation into conflict of interest violations involving Reed's attempt to influence CIRM staff on a grant application.

CIRM has been plagued since its inception by attendance and quorum problems, making it difficult to complete its official business. Part of the problem exists because of Prop. 71 language that requires a two-thirds quorum instead a simple majority of the 29-member board. Simpson said his analysis understates the attendance problem because a member is marked present if he or she attends only part of a session. On occasion, some directors seem to be fleeing for the exits in the waning hours of two-day meetings as they try catch planes, we have observed. Simpson wrote:

"At this month’s ICOC meeting Chairman Bob Klein was urging members to act quickly because the board would lose a quorum in 25 minutes. That’s no way to make substantive decisions affecting a $6 billion (including interest) program."

Simpson said,

"Patients hoping for stem cell cures rightly expect 100 percent commitment by board members.  If they can’t do that, the fair thing for everyone is to step aside."

Here is Simpson's complete attendance tally by member or alternate beginning in 2006:

"Ricardo Azziz — 14 of 14 — 100 percent
"David Baltimore — 10 of 10 — 100 percent
"Robert Birgeneau — 16 of 18 — 89 percent
"Keith L. Black — 2 of 2 — 100 percent
"Floyd Bloom — 6  of 6 — 100 percent
"David Brenner — 11 of 11 — 100 percent
"Susan Bryant — 17 of 18 — 94 percent
"Marsha Chandler — 3 of 7 — 43 percent
"Marcy Feit — 12 of 18 — 67 percent
"Michael Friedman — 15 of 18 — 83 percent
"Leeza Gibbons — 5 of 6 — 83 percent
"Michael Goldberg — 13 of 18 — 72 percent
"Brian E. Henderson — 14 of 15 — 93 percent
"Edward Holmes — 4 of 6 — 67 percent
"David Kessler — 10 of 13 — 77 percent
"Robert Klein — 18 of 18 — 100 percent
"Sherry Lansing — 16 of 18 — 89 percent
"Gerald Levey — 11 of 18 — 61 percent
"Ted Love — 15 of 18 — 83 percent
"Richard Murphy — 5 of 10 — 50 percent
"Tina Nova — 10 of 18 — 56 percent
"Ed Penhoet — 16 of 18 — 89 percent

"Philip Pizzo — 17 of 18 --- 94 percent
"Claire Pomeroy — 17 of 18 — 94 percent
"Francisco Prieto — 15 of 18 — 83 percent
"John Reed — 9 of 18 — 50 percent (Recused himself during ethics probe)
"Duane Roth — 16 of 16 — 100 percent
"Joan Samuelson — 12 of 18 — 67 percent
"David Serrano Sewell — 15 of 18 — 83 percent
"Jeff Sheehy — 15 of 18 — 83 percent
"Jonathan Shestack — 5 of 18 — 28 percent
"Oswald Steward — 16 of 18 — 89 percent
"Leon Thal — 6 of 6 — 100 percent
"Janet Wright — 15 of 15 — 100 percent."

CIRM's Secret 18 Disclosed

The Consumer Watchdog group today pulled away a bit of the veil of pseudo-secrecy that surrounds much of the grant process at California's $3 billion stem cell agency.

CIRM – most of the time – refuses to disclose the names of enterprises or individuals seeking its taxpayer-financed largess, unless they have actually won some CIRM cash. However, the agency chooses to identify applicants when it is convenient for CIRM purposes, as was the case in the mammoth lab grant program earlier this year.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., has long contended that good government practices demand the release of the names of those who seek funding from the state of California.

Today on his blog, he disclosed the names of 18 companies that were looking for grants from CIRM. Only one, Novocell, eventually received a grant, despite oft-expressed desires by some CIRM directors that California companies should receive the benefit of state financing.

Simpson noted that some rejected business applicants have complained about CIRM's review process, contending that it "is skewed towards academic science." Some CIRM directors have also questioned the approach of its scientific reviewers, saying that they may overlook worthwhile efforts that are heavily focused on bringing cures into the hospital. Simpson suggested that the companies he identified might want to get together and talk.

Simpson said the names were drawn from a document "used for internal CIRM vetting processes" involving letters of intent, which are required in order to apply for a grant. Simpson wrote:

"Here's the list of firms which filed an LOI (letters of intent) to apply for the Disease Team Planning Grant:  Advanced Cell Technology, Alameda; BioCardia Inc., South San Francisco; DNAmicroarray Inc., San Diego; Genomics Institue of Novartis Research Foundation, San Diego; International Stem Cell Corp., Oceanside, Novocell, San Diego; Panorama Research Inc., Mountain View; RegeneMed Inc., San Diego; StemCyte Inc., Covina; and Stemedica Cell Technologies, San Diego.

"Here are the companies that filed an LOI to apply for New Cell Lines Grant:  Advanced Cell Technology, Alameda; BioTime, Inc., Emeryville; California Institute of Molecular Medicine, Ventura; Cascade Life Sciences Inc, San Diego; DNAmicroarray Inc., San Diego; Gene Security Network, Portola Valley; International Stem Cell Corp., Oceanside, Raven Biotechnologies Inc., South San Francisco; RegeneMed Inc., San Diego; Supercentenarian Research Foundation, Inglewood; VistaGen Therapeutics Inc., South San Francisco and WaferGen Biosystems, Fremont."

A 'Booster Rocket' For Research in the 'Big Tomato'

The headline talks about the "dark side" of stem cells, but the piece was a bit of good news for the University of California, Davis, and particularly one man there who just won $2.2 million from the California stem cell agency.

Reporter Carrie Peyton Dahlberg of The Sacramento Bee reported this week about Paul Knoepfler(pictured), a scientist who recently received a faculty award grant from CIRM that he calls a "booster rocket" that will nearly double the budget of his lab.

Dahlberg wrote:

"His target is a gene that causes tumors – and that can transform adult skin cells into versatile stem cells similar to those in embryos."

She said his hope is to make potential stem cell therapies safer. Knoepfler was quoted as saying,

"I'm very optimistic. I don't think the hurdles we're facing are insurmountable."

Dalhberg also quoted Meri Firpo of the University of Minnesota and Joseph Wu of Stanford, commenting favorable on Knoepfler's work.

The Bee piece triggered one reader remark on its website that expressed appreciation for an objective report. The anonymous commentator said it was one of the few articles that have addressed the cancer risk involved in stem cell therapies.

UC Davis has received $38 million from CIRM during the last three years. The dean of its medical school, Claire Pomeroy, is listed as one of the 100 most powerful persons in Sacramento (along with Gov. Schwarzenegger) by Sacramento magazine. Pomeroy is also one of the 29 directors of the state stem cell agency.

Interestingly, she is not quoted either in The Bee article or the press release from UC Davis on Knoepfler. We assume that is the result of her own choice. Probably a good position to take considering the conflict of interest issues surrounding all the many academic and research executives who sit on the CIRM board and whose employers have benefited to the tune of hundreds of millions of dollars handed out by CIRM.

(Editor's note: For those of you unfamiliar with California geography, Davis is just west of Sacramento, where the UC Davis medical school is actually located. Sacramento is sometimes known as the Big Tomato because of the vast amounts of tomatoes that are grown in the area. In years past, the Sacramento River would run red in the summer from tomato waste from processing plants.)

Stemcellbattles.com Is Offline; Webmaster Hospitalized

We received the following from patient advocate Don Reed of Hayward, Ca.

"Karen Miner’s and my weblog, www.stemcellbattles.com, is down.

"Webmaster Karen(pictured) is in hospital, recovering from bladder augmentation surgery. The operation was done in hopes of freeing her from many problems of a personal nature, related to her spinal cord injury of fourteen years.

"We are in hopes she will recover fully, but for the foreseeable future, our small column, www.stemcellbattles.com, will not go forward. Karen was the webmaster; now her health will not permit her to carry on this unpaid chore.

"Selfishly, I am devastated.

"Not only did Karen’s webmastery give me a voice, but she and I have worked closely together for more than ten years. She is a part of everything I have done in research advocacy. Co-chair of Californians for Cures, Karen worked hard on the Roman Reed Spinal Cord Injury Research Act, Senator Deborah Ortiz’s stem cell laws, Bob Klein’s magnificent and unparalleled Proposition 71, and the four years continual defense of it afterward, in the unending attacks the California Institute for Regenerative Medicine has endured; always, Karen was there.

"Paralyzed in body but never in spirit, Karen Miner is a constant source of inspiration to me and all who have the blessing of knowing her.

"Anyone wishing to send Karen a get-well-soon email may send it me at: diverdonreed@pacbell.net. I will print them out and take them to her in the hospital.

"Don’t send anything electronically complicated or fancy, no e-cards, please. I don’t know how to work that stuff. Thanks.

"Don C. Reed
"Co-chair, Californians for Cures"

Changes in the California Stem Cell Report

We have made a few changes on this page that we hope will be useful to readers. For those of you hunting for a site feed (formerly at the very bottom of this web page), it can now be found at the top just to the left. We have moved the "Links" listings to place them above the archives of recent headlines. And we have added a "related content" gizmo at the end of each item. It is a device that will take you automatically to content that its creators think is connected to the subject of the posting on this report. It seems moderately useful although like most automated search engines it turns up irrelevant information as well. Your comments are welcome along with suggestions for additional changes and improvements. You post them by clicking on "comments" or you can send them to me directly: djensen@californiastemcellreport.com.

Fresh Comment

"Jim" has posted a comment on the "blog ban comment" item. Jim's item links to a Vadlo cartoon involving stem cell research and "Science" magazine.

Minimal News Coverage on CIRM Faculty Grants

News coverage of this week's $59 million in grants from the California stem cell agency was light today.

Most of the stories were heavily focused on the local impact of the grants. All appeared to have been written from the CIRM news release as opposed to actual coverage of the directors meeting.

Here is a listing of the stories we turned up.

Sacramento Bee

San Diego Union-Tribune, story by Terri Somers

San Francisco Chronicle, story by David Perlman

San Jose Business Journal

The Associated Press


Here is a listing of the news releases from recipient institutions.

Stanford

UC Irvine

University of California, statewide

UC San Diego

UC San Francisco

UCLA put out a news release that has not surfaced on its stem cell web site. You may be able to find it in the next day or two by going to the UCLA stem cell home home page.