More on the $505 Million for CIRM

The San Francisco Weekly, which produced a thorough overview of CIRM earlier this month, today picked up our report on the $505 million cash infusion that is expected to bail out the California stem cell agency.

Peter Jamison wrote,

"CIRM spokesman Don Gibbons said he could not confirm (David) Jensen's figures, because the agency has received nothing in writing from the state treasurer. However, Gibbons said CIRM 'has indications' that the report is accurate and hopes to make a definitive announcement at a board meeting next week in Los Angeles. Jensen quoted Robert Feyer, bond counsel to the treasurer's office, as confirming that $505 million was set aside for CIRM and would be available next Tuesday."

CIRM: Some Scientists' Grants to be Pulled

Some researchers who have been funded by California's $3 billion stem cell agency are going to lose their grants because of a lack of progress, according to a top CIRM official.

John Robson, CIRM vice president for operations, made the statement April 14 at a meeting of the Citizens Financial Accountability Oversight Committee, a five-member panel chaired by state Controller John Chiang, California's top fiscal officer. The committee is is charged with assessing CIRM's financial practices.

Robson's remarks came as part of a general response to questions about risk assessments by CIRM.

According to the transcript, he said,

"....(W)e get annual reviews, progress reports and our science officers go through those. And it's not a perfunctory exercise. They go through these things quite carefully. If there's things they don't understand or if it doesn't look (like) there's been much progress, they call up the PI (principal investigator) and they say, 'What's going on? You know, we've seen these experiments being done. What's your progress?' And then we work from there.

"If it turns out that there's no progress, we can cut the grant. I suspect that's going to happen. Some people are going to lose some grants."

Ruth Holton-Hodson, deputy controller for health and consumer policy, raised the questions about risk. She chaired the meeting in the absence of Chiang, who had suffered a foot injury, and said she brought up the matter on his behalf.

The Citizens Financial Accountability Oversight Committee is not to be confused with CIRM's Independent Citizens Oversight Committee, which is the 29-member CIRM board of directors. Chiang, a Democrat, is a statewide elected official. He was given the role of chairman of the financial accountability committee by Prop. 71, the ballot measure that created CIRM.

The CIRM board of directors meets next Tuesday and Wednesday in Los Angeles. Item No. 8 on the agenda is an "update on CIRM grantee progress report monitoring." No further details were provided on the agenda on that item.

State Bond Sale Provides $505 Million for CIRM

The California stem cell agency, once on its way to running out of money by next fall, is now slated to receive $505 million as the result of the sale this week of $6.86 billion in state bonds.

Robert Feyer of Orrick, Herrington & Sutcliffe, bond counsel to the state treasurer, told the California Stem Cell Report,

"I can confirm for your readers that the large state bond issue which was priced today (total of $6.855 billion) includes $505 million for the stem cell program. This money will be available next Tuesday, when the transaction closes."

CIRM Chairman Robert Klein is likely to discuss the impact of the funding at next week's board of directors meeting in Los Angeles. Feyer said that a "good portion" of the bond cash is expected to go for facilities grants. It is not clear whether CIRM will give up its plan to market state bonds privately.

CIRM relies almost totally on state bond funding. The measure that created the agency, Prop. 71, specified the nature of the funding so that CIRM did not have to ask the legislature and the governor for cash. Because of its budget crisis, California, until recently, had not sold any bonds since last June.

Translational Grant Reviews Now Available From CIRM

The California stem cell agency has posted the reviews of grant applications for $60 million for early translational research that will be awarded at next week's meeting of CIRM's board of directors in Los Angeles.

Ten grants are scheduled to be approved by directors. However, grant reviewers have given the okay to 15 totaling about $68 million. If the directors want to stay within their original budget, they will have to take the rare step of rejecting a positive decision on grants by reviewers.

The grants that have won reviewer approval include proposals dealing with cartilage regeneration and osteoarthritis, Alzheimer's, Parkinson's and macular degeneration. You can find the reviews here along with their scores.

The names of the applicants have been withheld by CIRM, but the identities of some may be discerned from the reviews by persons familiar with stem cell research.

Also now available on the directors' agenda is a side-by-side comparison of two federal bills dealing with biosimiliars, which are copies of the original biotechnological drugs following the expiration of patent protection. Directors are expected to be asked to take a position on the measures, but they will first be discussed Monday morning by the Legislative Subcommittee.

One of the bills, HR 1548, by Rep. Anna Eshoo, D-Palo Alto, is supported by the Biotechnology Industry Organization, which opposes a rival bill, HR 1427 by Rep. Henry Waxman, D-Los Angeles. It would be interesting to know whether CIRM's $240,000, federal lobbyist, the Podesta Group, is lobbying for or against either one of the bills.

With three business days remaining before the directors meeting, CIRM has not posted any background material on its possible position on the proposed NIH rules on hESC research and several other items. They include the monitoring of CIRM grantees, the agency's statewide education program and evaluation procedures for the chair, vice chair and president.

CIRM Board Meeting Will be Available on the Internet

Next week's meeting of the board of directors of the California stem cell agency can be heard on the Web via an audiocast, but it will not be available through a dial-in connection.

The Tuesday session begins at 4:30 p.m.and can be at this url: http://65.197.1.15/att/confcast

CIRM said interested parties should enter conference ID# 997897 then click go.

For the Wednesday session, use the same procedure beginning at 8:30 a.m.

The general procedure at CIRM board meetings is go over the grants on Tuesday, but other business is often taken up. CIRM Chairman Robert Klein is likely to open with a statement. CIRM President Alan Trounson could also make his report, including his take on the latest stem cell research in the news.

No audiocast via a dial-in connection will be available next week because of logistical issues, CIRM said.

CIRM Provides Justification for $200,000 for ISSCR Meeting

Much to its credit, the California stem cell agency Tuesday posted a dandy backgrounder on its recommendation that CIRM directors next week approve $200,000 to assist the International Society for Stem Cell Research with its convention in San Francisco in 2010.

The document is a far cry from the original request in December that sought $400,000 but did not provide any justification or explanation. This week's document is a good example of the type of information that CIRM can provide that assists in meaningful public participation in the agency's activities.

While one may or may not agree with the recommendation to co-sponsor the convention, CIRM does a fine job in pointing out the benefits to the agency, the state and science in general. The document lists eight benefits from the contribution, including no-cost attendance by CIRM staff and interaction of CIRM grantees and trainees with the world's top stem cell scientists. CIRM said,

"All of these benefits will be continuous reminders to the attendees, including the leading stem cell scientists in the world, that California drives the field and is an attractive, vibrant location for academic researchers and biotech companies. As new funding opportunities become available for stem cell research elsewhere, California cannot rest on its laurels, if it is to attract and retain the best scientists and companies. We think that conference co-sponsorship is a valuable means to enhance those efforts."

CIRM said that about 500 California scientists are expected to attend the 2010 meeting. (About 2,800 persons attended the ISSCR convention in 2008.)

CIRM said,

"If the meeting were to be held outside California, the increased travel costs alone for 500 attendees could easily exceed $250,000, much of which would have to be paid with CIRM grant funds."

We wonder about that assertion, largely because we were not aware that CIRM grants provided for travel and participation in the annual conventions of the ISSCR. This year's meeting is in Barcelona. One would think that financing international jaunts is not necessarily an appropriate use of taxpayer funds unless it can be very explicitly tied to the purpose of the grant.

Total cost of the San Francisco meeting is an estimated $1.5 million. CIRM is also helping out in arranging for the no-cost use of Moscone Center for the meeting and the rotunda at city hall for a reception. The value of those contributions by the City of San Francisco is placed at $125,000.

CIRM's proposed $200,000 contribution would go for travel expenses for organizers and speakers ($50,000) and conference services, publicity and publications ($150,000).

CIRM said the $200,000 should be taken from privately donated funds, which now total $3.4 million. That would be a good PR move, helping to ease any criticism of the expenditures. Nonetheless, the money is still public money. It became that when it was donated.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., publicly criticized the earlier CIRM moves to assist with the meeting. We have not heard from him yet on the latest proposal.

CIRM staff provided the breakdown and detailed justification for its recommendation as the result of requests by CIRM directors in December.

The recommendation for funding is expected to be voted on at next Tuesday's and Wednesday's meeting of the board of directors in Los Angeles.

CIRM to Hand Out $60 Million Next Week in Move Towards the Clinic

Directors of the California's financially troubled stem cell agency are likely to receive a bit of good news one week from today as they meet in Los Angeles to give away $60 million for projects to push stem cells into the clinic.

CIRM has been suffering from a cash crunch, but today the state of California is going to market with as much as $4 billion in taxable bonds. CIRM is on tap to receive a good chunk of that, probably enough to keep it from running out of funds by this fall.

The bond sale is not mentioned in the formal agenda, but Chairman Bob Klein will certainly discuss it along with his plan to sell state bonds privately on behalf of the $3 billion enterprise.

The directors are also scheduled to approve 10 grants totaling $60 million for early translational research. CIRM says the awards

"...are designed to move promising basic research in stem cell science toward the clinic. 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."

The topic of the awards could trigger general discussion of the direction of CIRM and its strategic plan, although the plan is not on the agenda. CIRM President Alan Trounson may bring it up during his report to the board.

CIRM's direction recently came under review in a piece in the San Francisco Weekly that was headlined "Stem-cell stalemate: The push for cures may produce only disappointment - or worse."

Also on tap is the proposed co-sponsorship of the 2010 San Francisco convention of the International Society for Stem Cell Research. The latest price tag for that is $250,000, down from $400,000. CIRM has said it will help the group raise $150,000, a move that drew some fire from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca.

Also on tap are evaluation procedures for CIRM's chair, vice chair and president along with consideration of two pieces of federal legislation and the proposed NIH rules for human embryonic stem cell research (see "CIRM and the NIH").

As usual, CIRM has not provided any links or background information on all these issues on the agenda on its web site. That means that the public is hard pressed to determine the significance of the cryptic listings of matters to come before directors of the world's largest source of funding for human embryonic stem cell research. Without some frame of reference, interested parties – be they business, academic or otherwise – find it difficult to determine whether their enterprises are being affected.

Although Klein has repeatedly pledged to adhere to the highest standards of openness, CIRM's chronic failure to post background material in a timely fashion demonstrates the bankruptcy of that pledge.

We are asking CIRM whether there are issues or other problems that we do not understand concerning the failure to post background material.

CIRM and the NIH: A Stand on the Proposed hESC Rules?

Directors of the California stem cell agency next week will take up the proposed NIH regulations for human embryonic stem cell research that have triggered dismay among some scientists in the state and elsewhere.

The topic is on the agenda of the CIRM directors' Legislative Subcommittee meeting one week from today and then it comes before the full board the following day or two at its Los Angeles meeting.

In the eyes of some influential scientists, the proposed regulations are too restrictive. Irv Weissman of Stanford promptly criticized them last Friday as just substituting one ideology for another. Susan Fisher, co-director of stem cell research at UC San Francisco, also was not pleased. She told Lisa Krieger of the San Jose Mercury News,

"This mostly moves the line in the sand from 2001 to 2009."

Fisher said,

"We still desperately need CIRM and private funding,"

On the East Coast, reporter Ceci Connolly of the Washington Post wrote,

"'I am really, really startled,' said Susan L. Solomon, chief executive of the private New York Stem Cell Foundation. 'This seems to be a political calculus when what we want in this country is a scientific research calculus.'"

Generally, however, the proposed NIH rules received mild or better praise in most of the stories that we have seen. Jesse Reynolds of the Center for Genetics and Society in Oakland, Ca., wrote on his organization's blog, Biopolitical Times, that the NIH "got it right."

He said the regulations are "consistent with his (Obama's) campaign promises, consistent with public opinion, and draw lines in a way that will allow promising research to go forward while preventing potential abuses."

It was clear, however, that the NIH rules are very much a product that was based on a reading of public opinion about stem cell science, a fact that was mentioned in several stories.

Reporter Gardiner Harris of the New York Times also noted a bit of presidential political history, writing,

"During the campaign last year, Mr. Obama said he supported 'therapeutic cloning of stem cells,' a policy his administration rejected Friday. A White House spokesman, Reid Cherlin, said the president 'directed N.I.H. to formulate the best method for moving forward with stem cell research, both ethically and scientifically,' in an independent process."

CIRM's decision to place the regulations before its directors raises some interesting questions.
What does CIRM have to gain by entering this particular fray? Failure to oppose them will alienate some influential researchers and perhaps their parent institutions.

Supporting the rules could be regarded as institutionally self-serving and as an attempt to justify the continued existence of CIRM, whose origins were based on former President Bush's restrictive policies. Some of have argued that CIRM is now irrelevant, given Obama's moves and the changing nature of stem cell science. However, it is hard to see how $3 billion in research funding could be considered irrelevant by anyone. The NIH is certainly not going to fund all the fondest desires of even those who qualify under its proposed rules.

Also on next week's CIRM agendas are other federal matters that could place CIRM in the middle of a pharmaceutical war. Up for consideration by CIRM directors are two Congressional bills involving biosimiliars – HR 1427 by Rep. Henry Waxman, D-Los Angeles, and HR 1548 by Rep. Anna Eshoo, D-Palo Alto.

The Biotechnology Industry Organization does not care for Waxman's bill, declaring that it "would jeopardize patient safety and undermine future medical breakthroughs," according to Patricia Van Arnum of Pharmatech.com. Waxman, of course, thinks differently.

He said his bill would "allow the Food and Drug Administration to approve affordable copies of biotech drugs." He said,

"Biotech drugs, while often life-saving, are the fastest growing and most expensive components of the nation’s prescription drug bill."

BIO favors Eshoo's bill, according to Van Arnum, declaring that it balances "the need to increase access, lower costs, ensure drug safety and promote continued biomedical breakthroughs."

The Legislative Subcommittee meeting will have teleconference access available 7:30 a.m. next Monday at seven locations: two in San Francisco and others in Portola Valley, Menlo Park, Elk Grove, Healdsburg and La Jolla. You can listen in and participate from those locations. If you are unable to attend, you may submit a statement by sending it to info@cirm.ca.gov.

The full board meeting does not have interactive teleconference access, but it may be available via the Internet and a phone line audiocast.

We invite comment on this item and CIRM's role in NIH affairs. You can submit comments by clicking on the word "comments" below. Anonymous comments are permitted.

Torres, Palin and Stem Cell Research

It was the first known public comment by a member of the board of directors of the California stem cell agency on onetime vice presidential nominee Sarah Palin.

The remarks came Friday from Art Torres, recently elected co- vice chairman of the CIRM board,

The occasion was a tour of stem cell lab facilities at UC San Francisco and the Gladstone Institute involving House Speaker Nancy Pelosi, according to an account by reporter Carla Marinucci in the San Francisco Chronicle.

Pelosi was asked about comments by Palin, attacking President Obama for his support for hESC research. Pelosi stoutly defended the research, declaring, "We need science, science, science, science, science."

Torres said that Palin's comments were "very disappointing...because it's such a blatant campaign move."

Marinucci wrote,

"He said she was 'playing to the crowd' for a 2012 run, but hasn't offered any alternatives to the major advances that might be made in biomedical research."

Readers left 124 comments on the Chronicle piece, but not one mentioned Torres' comments, as far as we can tell. However, one commentator said that Pelosi said science only four times – not five.

Stanford's Weissman Flays Proposed NIH hESC Regs

The NIH's proposed hESC regulations were hardly off the presses today before they came under fire from an eminent stem cell researcher for flying in the face of President Obama's March proclamation on stem cell research.

Irv Weissman(pictured), director of stem cell research at Stanford, took on the NIH in a news release from the Stanfod School of Medicine.

Weissman said,

"Instead of facts, the NIH placed its own version of ethics in place of the president’s clear proclamation. As head of the National Academy of Sciences' panel that unanimously endorsed research using SCNT, and as a drafter of the guidelines for the International Society for Stem Cell Research, I know that this suggested ban on federal funding of SCNT-derived human embryonic stem cell lines is against our policies and against President Obama’s March 9 comments. The NIH has not served its president well."

The news release continued,

"'I am happy that these are draft guidelines,” said Weissman, who noted that the NIH did not solicit input from either the National Academy of Sciences or the International Society for Stem Cell Research during the consensus process. 'I’d like to remind the NIH of the principles enunciated by the president on March 9. Research in this area is moving very fast, and it’s not possible to say whether advances will come from work on adult-derived iPS cells or from embryonic stem cells created by nuclear transfer. Policy needs to be developed as the field develops, rather than precluding something based on ideology.'"

Across San Francisco Bay in Oakland, the Center for Genetics and Society praised the regulations,

Its news release said,

"Cloning-based stem cell research lays the technical foundation for human reproductive cloning - which the U.S., unlike dozens of other countries, has not yet prohibited - and requires enormous numbers of human eggs, whose extraction poses health risks to women. Despite years of work, no researcher has created a clonal human embryo viable enough to yield stem cells," said Jesse Reynolds, policy analyst at the Center. "In contrast, alternative methods of cellular reprogramming have largely achieved the goals of cloning-based work. The NIH was wise in leaving such risky work outside the domain of federal funding."

The group did not address CIRM's position on the proposed rules, but it has been an advocate of strong national standards.

CIRM Able to Fund Research Excluded by Proposed NIH Regulations

The California stem cell agency today said that the proposed NIH regulations for human embryonic stem cell research are "largely consistent" with the state regulations, although CIRM will be able to fund projects that would be barred from federal funds.

The agency issued a news release on the matter this afternoon. It said,

"The conditions required by the NIH are largely consistent with requirements CIRM has developed for derivation performed by our grantees, according to Geoff Lomax, senior officer for medical and ethical standards. 'For our grantees working with lines derived under CIRM standards, these regulations open the door to broader sources of funding, expanding important research in California,' Lomax said.

"Lomax said that under both sets of guidelines, researchers hoping to use a particular stem cell line must prove that the couple who donated the embryo knew that they would not personally benefit from the work, that they would not benefit from possible commercial applications of the cells, and that they could not place restrictions on the type of research performed with the cell line, among other conditions. He added that CIRM may need to make a minor revision to its regulations requiring that couples be specifically informed of all options for disposing of their excess embryos before donating to research.

"Lomax added that there are important avenues of research funded by CIRM that are prohibited under the draft regulations. These include the creation of new stem cell lines, and any work with lines created through nuclear transfer (sometimes called therapeutic cloning) or parthenogenesis, in which the egg is stimulated to begin division without fertilization.

"'CIRM remains a critical source of funding in California for work that is not eligible for funding by the NIH but that has important scientific value,' Lomax said. For example, embryonic stem cell lines created through parthenogenesis are genetically identical to the donor and could be an important source of stem cells for therapies."

UC Sounds Cautionary Note on Stem Cell Therapy Amid 'Guarded Optimism'

Rays of economic hope were scattered through two stem cell/biotech conferences this week in the San Francisco Bay Area – one focusing on industry and one more oriented towards academe.

The BayBio industry group sponsored one meeting in South San Francisco that attracted 700 participants, according to David Morill's account on InsideBayArea.com, a Web site for six daily newspapers in that area.

While acknowledging the difficult economic times, Morrill quoted Matt Gardner, president of BayBio, as saying,

"We've had a couple of companies shut down, but overall there is definitely a guarded optimism here. There is a lot of focus this year on partnering and venture marketing."

No one from the mainstream media wrote about the other affair so the University of California presented its version online in an article by an unnamed author.

UC reported that 320 researchers, biotech execs and money folks attended the April 15 meeting hosted by the UC Office of Technology Transfer and the British and Canadian consulates. One speaker, Gregory Bonfiglio of Proteus Venture Partners, said the commercial market in regenerative medicine will grow to $118 billion next year compared to $3.6 billion last year.

UC took pride in pointing out that it has snagged $420 million out of the $694 million that CIRM has handed out in research and construction grants. The university did not mention that 11 of the 29 members of the CIRM board of directors, which sets both the rules for grants and awards them, have links to the University of California.

UC also fired a shot in the debate about CIRM's push into clinical trials vs. basic research. And given that the article came from the Office of the President, it carries some considerable weight. Here is what it said,

"The biggest contribution UC is making to this new stem cell economy is in advancing basic research and training, said Steven Beckwith, vice president of research and graduate studies in the UC office of the President, who delivered one of the keynote speeches at the forum.

"'There are now avenues where stem cells can be used for therapeutic remedies, but they're limited,' Beckwith said. The real potential won't be realized until we understand the fundamental mechanisms behind these cells. That's the strength of university research.'"

San Diego's Stem Cell Consortium Still Hunting For Cash

San Diego's Sanford stem cell consortium is buoyed by the latest assurances that it will receive $43 million from CIRM to assist with its new research lab, but it still needs to borrow as much as $65 million more, the San Diego Union-Tribune reported today.

Reporter Terri Somers wrote:

"For months, the state could not sell bonds to support voter-approved projects such as the stem cell institute because it did not have an approved budget. And some lenders questioned whether the fiscally challenged state could make good on its promise to provide the consortium's funding. The escrow account should address those fears, said Louis Coffman, the consortium's vice president.

"UCSD Chancellor Marye Anne Fox also welcomed the news.

“We are happy to learn that we are now one step closer to building an important new stem cell research facility for the Sanford Consortium for Regenerative Medicine, which will enable researchers from the University of California San Diego, the Salk Institute, the Burnham Institute and The Scripps Research Institute to more effectively collaborate to find cures for some of the world's most devastating diseases,' Fox said."

Somers also wrote,

"'Now we can go to the market and say there is no risk associated with the California money,' Coffman said.

"To raise the rest of its financing, the consortium has selected Barclay's Capital as its investment banker to underwrite a bond offering, Coffman said.

"The underwriter typically agrees to buy a certain amount of bonds, and then sell them to investors on behalf of the consortium.

"The consortium has also applied for funding from the federal stimulus package, which would be administered through a grant from the National Institutes of Health, Coffman said. Any stimulus money received would reduce the amount of funding the consortium would have to raise through the bond financing, he said."

Somers reported that ground has not been broken on the project, which raises questions about whether the consortium can meet the CIRM completion deadline. The labs were to have been finished within two years, according to a CIRM news release May 7, 2008.

Stem Cells and Cyberspace Info

Jim Till, a member of the board of the Cancer Stem Cell Consortium in Canada, runs a blog called the Cancer Stem Cell News.

Most of it appears oriented towards nitty-gritty research, but occasionally he picks up other types of information. Today he linked to the San Francisco Weekly piece on CIRM with an acknowledgement that he found it via the California Stem Cell Report.

Till carried a paragraph from the Weekly's story but otherwise offered no comment.

Till's blog is a good example of how news and information originally targeted for a geographically small audience can rocket around the world, courtesy of the Internet. With the waning power of the print media and its TV and radio cousins, the Web is increasingly likely to be a key information source on relatively specialized topics such as stem cell research – more so than general news.

The conduct of stem cell research would not have been high profile news even during the golden days of newspapers. Less so now and in the years to come.

New Stem Cell Patent Ruckus in California

The delicate interface between science and business has come a cropper again.

The latest set-to involves the National Human Neural Stem Cell Resource of Children's Hospital of Orange County Research Institute and Stem Cells Inc. of Palo Alto, Ca.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., Wednesday provided a summary of the dispute. He reported that Philip Schwartz, head of the Resource, said his organization's efforts to promote research with human neural stem cells has been effectively blocked by patents held by Stem Cells Inc.

The entire story can be read on Simpson's organization's blog along with a response from Stem Cells, which said it did not control actions by the Resource.

The situation reminds us of a book, "Science Business," by Harvard business professor Gary Pisano, published a couple of years ago. He has studied and consulted with the biotech industry for decades and has written about its consistent lack of profits. He suggests that part of the problem lies in the "monetization of IP" and inappropriate application of high tech industry IP principles in the biotech industry.

In 2006, he said in an interview on the Harvard Business School web site:

"Science and business work differently. They have different cultures, values, and norms. For instance, science holds methods sacred; business cherishes results. Science should be about openness; business is about secrecy. Science demands validity; business requires utility. So, the tensions are deep.

"What has happened is that we have tried to mash these two worlds together in biotech and may not be doing either very well. Science could be suffering and business certainly is suffering. If you try to take something that is science, and then jam it into normal business institutions, it just doesn't work that well for either science or business."

Stem Cells Inc. was founded by scientists Irv Weissman of Stanford, Fred Gage of the Salk Institute and David Anderson of Caltech.

Simpson wrote,

"You would have thought that with academic heavyweights like these involved with the company it would have been a no-brainer to figure out a way for Schwartz to distribute cells he has derived from CHOC patients to qualified researchers.

"The root of the problem is the Bayh-Dole act governing federally funded research. It has turned our universities into commercial entities where scientists rush to patent their discoveries rather than rush to publish and explain them."

We are querying Weissman, Gage and Anderson about their thoughts on the general issues raised by Schwartz along with the specifics.

Simpson's piece was the result of a notice by Schwartz to about 2,700 persons, mostly academics, about the patent issue. Simpson sent out a note to about 75 journalists nationwide about his item.

Stem Cells and Three California Movers and Shakers

The Capitol Weekly newspaper in Sacramento today identified three men with close ties to California stem cell issues as among the top 50 political players in the state.

The list included Eli Broad, Richard Blum and the man behind CIRM's Sacramento lobbying firm. The rankings did not include elected officials, such as the governor, who is a good friend of the California stem cell agency.

Ranked No. 5 was Broad, the Los Angeles billionaire businessman who has funded stem cell research at UCLA, USC and UC San Francisco with tens of millions of dollars. In the 2007-08 election cycle, he spent nearly $1 million on political efforts. "If money talks, then everybody listens to Eli...," the newspaper reported.

Ranked No. 6 was Steve Merksamer of the firm of Nielsen, Merksamer, Parrinello, Mueller & Naylor, which is the Sacramento lobbyist for CIRM. Merksamer was one of its founding partners. The firm has been on retainer with CIRM since the agency's earliest days and currently has a $49,200-a-year contract with the agency for its services, which CIRM coyly describes as "public education." Capitol Weekly said Merksamer is "is one of the state’s most influential political-legal players. His 16-lawyer firm is involved in a myriad of political issues and dispenses legal advice and political strategy to a national and international big-business clientele."

Ranked No. 14 was Blum, chairman and president, Blum Capital, a major equity investment management firm. Blum is a University of California regent as is Sherry Lansing, a member of the board of directors of CIRM. Blum is also the husband of Democratic U.S. Sen. Dianne Feinstein. Blum Capital Partners purchased $1 million in bond anticipation notes to help fund CIRM in 2006.

The list of 50 is the first installment in a Top 100 count, with more "influence peddlers, power brokers and political players" to come next week.

The California Stem Cell Story: Safety, Waste and Promises

The story was about CIRM, and the headline said,

"Stem-cell stalemate: The push for cures may produce only disappointment - or worse."

Written by Peter Jamison for the San Francisco Weekly, the lengthy and thorough-going article explored the promise of California's $3 billion stem cell research effort and how it measures up. Jamison focused on CIRM's move towards pushing therapies into the clinic and away from basic stem cell research.

The article appeared in a free newspaper that reports 100,000 weekly circulation with 500,000 monthly readers and 1.5 million page views (presumably weekly) on its Web site.

Jamison said that when Prop. 71 was passed in 2004, it was fueled "by promises of cures and therapies that appeared, to the layperson, little short of miracles." He wrote,

"Many in the medical community, while paying lip service to the optimism of 2004, acknowledge the very real possibility that people suffering from the incurable conditions typically associated with stem cells — not just Parkinson's or diabetes but Huntington's disease, multiple sclerosis, and HIV/AIDS, among others — will not see a therapy or cure from the state's $3 billion investment."

Jamison continued,

"In short, the question is whether CIRM should become an agency that pays tens of millions of dollars to alleviate arthritis while research languishes on Huntington's disease or multiple sclerosis. This approach could go a long way toward addressing the more serious safety concerns voiced by some scientists. It is also a remarkable detour, by any standard, from the ambitious medical goals that drove Prop. 71. It is difficult to overlook the irony of a situation in which state officials, seeking to deliver on the promises of a ballot initiative intended to overcome the Bush administration's supposed limits on the advance of science, turn for their salvation to research Bush never restricted in the first place. Will California voters accept such a momentous policy shift?"

Jamison interviewed a wide range of scientists including those at CIRM. He quoted Arnold Kriegstein, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UC San Francisco, on the risks of CIRM's turn towards the clinic.

"The likelihood of something going wrong is pretty high. Something like tumors are probably going to happen. This is an area where the risks are great. The public has to be prepared."

Marie Csete, chief scientific officer at CIRM, took another view. Jamison wrote that "she was quick to counter suggestions that the agency's new funding priorities would put patients in danger."

Csete said,

"'It's just a ridiculous idea that we're not putting safety first....This field is moving very quickly toward clinical application. There's no question in my mind, and it would be silly for us to say that we have to solve every single problem before we proceed to transplantation' of cells into humans."

Hans Keirstad of UC Irvine was quoted as saying,

"'You will always garner respect by saying, 'Slow down. More science is necessary....Somewhere out there there's got to be compassion for those patients who are dying. I would go so far as to say that inaction is killing people. The views of ultraconservative scientists are killing people.'"

Waste was another topic. Jamison quoted Bruce Conklin, a senior researcher in the Gladstone Institute's cardiovascular disease division, as saying,

"'We all want the same thing — we want to see regenerative medicine work....Although there's $2 billion [of CIRM money] left to give out, that's actually a very small amount of money. Now, if that's all spent on clinical trials that don't tell us anything because they don't work, that's a missed opportunity.'"

Warner Greene, director of the Gladstone Institute of Virology and Immunology, said,

"There's no way to hop over this basic biology."

Jamison additionally interviewed Jeff Sheehy, one of the 29 persons on the CIRM board of directors, who talked about an "identity issue" at CIRM. Jamison wrote,

"'If we are going to say that we're going to work with adult stem cells, we can be in the translational phase and the clinic now,' says Sheehy, who is communications director for UCSF's AIDS Research Institute and represents the interests of HIV patients to the board. 'While they're going to be of benefit to a great many people in California, these adult-stem-cell approaches are probably not going to have a big impact on these severe degenerative diseases that really motivated a great number of people to support Prop. 71, like Alzheimer's, Parkinson's, spinal-cord injuries.'"

Many of the issues addressed by Jamison are part of the current review of the CIRM strategic plan. The agency last month conducted two public hearings on plan and its proposed changes. You can find the transcripts here under the topic "interested persons meetings." The latest version of the plan may well surface at the CIRM directors meeting April 28-29 in Los Angeles.

But for many, Jamison wrote, CIRM's activities are more than a debate about strategy and basic research vs. translational research. He said,

"Whatever the voters who supported Prop. 71 think of the use of their money to support adult stem-cell cures for relatively pedestrian ailments, they would almost surely be angered if the ballot initiative's billions of dollars have bought, after a decade, only a sheaf of much-lauded studies in the journal Cell.

"Even angrier, no doubt, would be the people who suffer from the diseases stem cells might one day cure. Their voices, more than any others, persuaded a majority of the state electorate to support Prop. 71."

We asked Don Gibbons, chief communications officer for CIRM, if the agency had a comment on the article for this item. He replied,

"I just hope you encourage your readers to read the entire article and not just the negative snippets you choose to use."

We certainly hope that you all take a look at Jamison's piece, which airs, in a very public way, some important scientific and policy questions that have not yet been widely examined in California.

Your comments are invited on this and any other topics. Click on the word "comments" below to send them in unmoderated. Anonymous comments are permitted.

(Editor's note: An earlier version of this item incorrectly attributed the "hop-over" quotation to Bruce Conklin, not Warner Greene.)

Money for CIRM, But It Still Needs More

The California stem cell agency today received some good financial news from the folks at an obscure state entity called the Pooled Money Investment Board.

The board, which operates out of the state treasurer's office, renewed a $295 million loan to CIRM and approved $43 million in additional funds from the board, according to Tom Dresslar, spokesman for Treasurer Bill Lockyer.

One unconfirmed report had it that the $43 million was destined for stem cell lab construction in the San Diego area involving the Sanford consortium (UC San Diego, Salk, Scripps and Burnham).

We queried CIRM on the matter, and spokesman Don Gibbons said the money would improve the agency's cash flow. Later Gibbons explicitly said the money would go to the Sanford project.

If the board had not renewed the loan, it would have weakened CIRM financially. But CIRM remains in dire straits unless it gets significant help from the upcoming state taxable bond sale.

The Pooled Money board manages state cash flow and provides interim financing for state and local projects while they await bond proceeds.

(An earlier version of this item said that Gibbons would not confirm that the money would go to San Diego. Later in the day, he said it would.)

Hearing on Stem Cell Education Measure Coming Up

Legislation designed to make stem cell education a part of California's state public school curriculum will be considered on April 29 by the state Senate Education Committee.

The measure, SB 471, cites the California stem cell agency and its research efforts as the impetus for for the proposal.

The bill by Sen. Gloria Romero, D-East Los Angeles, and Senate President Pro Tem Darrell Steinberg, D-Sacramento, says that the state Board of Education as well as the community colleges, the state college system and the University of California "should collaborate to help CIRM advance its education initiatives." The Board of Education controls matters in grades kindergarten through 12. Romero (pictured) heads the Senate Education Committee.

Her bill was discussed at a meeting of the CIRM directors' Legislative Subcommittee on March 31.

No transcript of the meeting is yet available, but a spokesman for CIRM, Don Gibbons, said recently that no position was taken on the bill, along with another measure aimed at ensuring affordable access to any therapies developed with CIRM-funded research.

Gibbons said,

"They just felt the bills were not sufficiently fleshed out to have a formal position taken."

The affordable access bill, SB 343 by Sen. Elaine Alquist, D-San Jose, is a somewhat altered version of a measure opposed by CIRM last year and vetoed by the governor. The bill is now before the Senate Health Committee but no hearing date has been scheduled. Alquist is chair of the Health Committee.

As to whether the full CIRM board will consider the legislation at its meeting April 28-29, Gibbons said,

"Who knows if the full board will take it up at the end of the month. "

CIRM Not Obsessing Over Bond Sales

The California stem cell agency apparently intends to proceed with plans to privately market state bonds, despite an expected influx of cash from a much larger sale later this month, according to a blog of Nature magazine.

Writing on The Niche, Monya Baker reported last week that CIRM is "moving ahead with plans" to sell bonds privately. She sourced her information to Don Gibbons, chief communications officer for CIRM.

Meanwhile Time magazine today carried a piece that is not going to make it any easier for CIRM or the state of California to market bonds.

The headline said, "Rising Risks in Muni Bonds Worry Investors." (Muni bonds refer to both state and local government bonds.)

The article said,

"A growing number of analysts and financial planners are raising doubts about the bonds of local and state governments."

But Baker reported that Gibbons said CIRM is not "obsessing over the bond sales." She quoted Gibbons as saying,

“The feeling here is that the money will come through for us when we need it. That someone will find a way.”