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.”

Dodging the Salary Bullet

Most of the time we write about things that affect CIRM. Here is one thing that won't – legislation to freeze salaries of high paid state employees.

The measure, AB 53, would impose a two-year ban on raises of about 785 state employees who make more than $150,000 annually. It is now before Assembly Appropriations Committee after winning unanimous approval from the Assembly Public Employees Committee on April 1.

The logic behind the bill by Anthony Portantino, D-La Canada, is that well-paid state employees should share the pain of budget cuts affecting children, seniors and so forth. The California stem cell agency has a bunch of folks who make more than $150,000 – too many in the eyes of some critics.

However, California lawmakers are politically unable to touch the agency because of Prop. 71, which requires an unprecedented 70 percent, super-majority vote of both houses and the signature of the governor to change state law affecting CIRM.

The significance of the legislation concerning CIRM is that high salaries are a red flag issue for the public even though they may be justified. Check out some of the comments on the story in The Sacramento Bee on the measure.

CIRM To Censor Confrontational Comments on its Facebook Site

Call it stem cell cyberspace – California style.

The $3 billion California stem cell agenda has embarked on a major foray into the Internet's social networking scene. It now has a fairly hefty presence on Facebook, YouTube and Flickr – all part of the expansion of its communications and public relations operations.

CIRM's Internet doppelgangers represent a creative attempt to use the latest tools to reach a wide audience, including those who might not necessarily tune into the old-fashioned print media.

But the Facebook account raises a significant public policy issue: Should taxpayer funds be used for a Web page that explicitly warns that a state agency (CIRM) will censor comments that it does not like?

Here is what the stem cell agency says on Facebook:

"CIRM's Facebook page is a place to learn more about stem cell research in California and around the world. We encourage comments on the science in our posts and our blog entries and will post regular responses from CIRM's in-house scientists or from our grantees. We will remove posts that are confrontational in nature."(Our boldface)

We asked Don Gibbons, the agency's chief communications officer and the man responsible for the cyberspace outreach, four questions about CIRM's policy on "confrontational" posts.

"How does CIRM define confrontational?

"Is it appropriate for public state agency to restrict commentary on taxpayer-funded scientific and policy matters?

"Is such a ban in keeping with the best standards for discussion of scientific matters?

"Do you know of any other state agency with such a policy?"

Gibbons replied,

"Our policy is essentially the same as yours. The goal of the site is to foster free and open discussion of the science. We will be very conservative in deciding to remove posts, reserving that action for anything that unfairly questions the integrity of our funded researchers or of stem cell science in general. Compare it to you taking down the recent posting about President Obama on your site."

Aside from the fact that the California Stem Cell Report is not funded by taxpayers or any business or organization, CIRM misses the point.

By warning its Facebook readers that their comments could be expunged, CIRM stifles legitimate commentary about CIRM's operations. It is as if the state began publishing a newspaper and warned the public that it would not print letters from readers or op-ed pieces that it deemed confrontational or unfair.

Beyond that, science -- not to mention government -- requires a robust dialog. One researcher's questions may be considered confrontational or unfair by another whose work is being scrutinized. Does that mean that the concerns should not be voiced in a public way? (See this link for an interesting related lawsuit.)

Yes, the Internet is a wild place. People say many rash things in cyberspace, and there is a problem with commentary that can be obscene and racist as was the case in the Obama comment that we deleted from the California Stem Cell Report. But obscenity and racism are a far cry from comments that are confrontational or unfair.

How will CIRM handle a comment from a person who deeply believes that hESC research involves the destruction of human life, says something to that effect on the Facebook page and suggests that hESC scientists are baby-killers? How will it deal with a comment that says the CIRM board of directors is riddled with conflicts of interest and the agency should be abolished.? Would the agency allow remarks from the scathing column about CIRM that recently appeared in the Los Angeles Times? Would the agency allow comments from stem cell scientists that suggest it is going badly awry in an endeavor to cozy up to the biotech industry?

All of those comments could be considered unfair or confrontational.

The problem here is not with the Facebook page. It is with the fact that CIRM is allowing comments to be posted on the page and supposedly encouraging them, but only if they are "correct" in the eyes of some at CIRM.

Web sites have been wrestling with the problem of untrammeled commentary since the 1990s. A variety of controls have emerged on private sites. But private Web sites are a wholly different animal than a Web site funded by taxpayers.

CIRM should encourage the broadest of commentary on its Facebook page and as well on its main home page. From time to time, it may well have to delete a comment that is obscene, racist or libelous.

But it should narrowly define what it would remove. Comments that are confrontational or unfair should not be censored. And comments that question "the integrity of ... stem cell science in general" certainly should be allowed. CIRM can and should rebut comments. That is the value of open dialog, which is paramount to a successful democracy.

We welcome comments on this and all other topics, confrontational or otherwise. You can make them by clicking on the word "comments" below. Anonymous comments are permitted.

(Editor's note: Gibbons' response also made reference to an item that we deleted last month along with a related comment from him. We posted notes explaining the deletions. You can find them here. For more on the CIRM's cyberspace efforts, see the item below.)

CIRM Facebook Likely a Pioneer Effort Among State Agencies

The California stem cell agency's use of Facebook, YouTube and Flickr seems to be relatively novel among state departments.

Our web searches did not turn up any other California state agencies with Facebook pages, but given the nature of Internet searches some may, in fact, actually exist. Some state college campuses (Stanislaus, Chico and others) have Facebook pages as does UC Berkeley. Most of the ones we looked at show light activity.

CIRM's effort is not the only Facebook page called the "California Institute for Regenerative Medicine." Another, created by Judy Roberson, can be found here, but it appears largely moribund. Another CIRM-related site was started by attendees at a CIRM meeting in 2008 in San Francisco.

The CIRM Facebook page does not yet appear to have generated major traffic. Only 55 "fans" are registered, as of this writing. It has been up since at least late February although it was just announced this week. CIRM's YouTube site reports 23 subscribers with 1,705 "channel views" since its inception Jan. 15. (The state has a number of YouTube pages including a state YouTube Channel, which has had only 33,848 channel views since March of 2008.) We could not find viewing numbers on Flickr site.

Low usage is normal for early-stage web sites. Driving traffic to a web site is a continuing challenge unless you have a brand name such as the New York Times or President Obama.

CIRM's Facebook page compares favorably in terms of usage to the U.S. government's Facebook page, which has only 489 fans but obviously a much larger user base.

The content on CIRM's Facebook and the other pages consists primarily of material that can found already on the main CIRM web site. Some links are provided to news stories about CIRM, although none of the stories contained significant critical remarks. The Facebook page does promise both blogs from CIRM staffers and interactivity, with CIRM personnel responding to questions.

CIRM's cyberspace efforts seem relatively low cost. But, web pages must be freshened regularly with new content and nurtured with marketing drives to push traffic. Otherwise they whither. In a year or so, CIRM should examine the reader numbers from the sites to determine whether its tiny staff can justify continuing these fledgling endeavors.

CIRM Says Cash Will Come From This Month's Bond Sale

The California stem cell agency confirmed this afternoon that it expects to receive cash from the proceeds of a $3 billion to $4 billion taxable state bond sale later this month.

In response to an inquiry from the California Stem Cell Report, Don Gibbons, a spokesman for CIRM, said,

"We have been told we could receive some level of new direct funding through the bonds that are scheduled to be issued beginning April 20."

Gibbons did not specify an amount or a range or whether it would be enough to scrub plans for a private state bond sale effort by CIRM.

However, we believe that it is quite likely that the amount will be sufficient to fund CIRM at least through this year or until the state's bond mavens believe that another taxable bond issue can be offered.

CIRM Bond Effort Still a Possibility

The private sale of bonds by the California stem cell agency could remain an option, according to the California state treasurer's office.

Tom Dresslar, spokesman for Treasurer Bill Lockyer, made the comment today in response to questions from the California Stem Cell Report.

CIRM has not responded to our inquiries concerning the reports that proceeds from a $3 billion to $4 billion taxable bond sale this month sale would help out CIRM. John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., predicted that the CIRM would snag about $400 million. (See his comment on the "cash infusion" item.)

We asked Dresslar for his comments on the bond sales reports. In his initial response, he said,

"We will sell taxable bonds. Proceeds can be used on taxable bond-funded projects, including stem cell. We hope to pay the PMIA for the outstanding 250 million loan to CIRM.

Then we asked him,

"Will funds be available for grants and operations beyond the repayment of that loan? If the funds are used in that fashion, will it enable CIRM to take out a new loan? In other words, does CIRM need to continue its plans to privately market bonds? Are the items I have been writing concerning the LA Times and Bond Buyer stories off base?"

Dresslar replied,

"It will be up to the Department of Finance to allocate funds from bond sale. But about 1 billion of the proceeds will be used to replenish PMIA for outstanding loans, including CIRM. There will be no new loans, at least for the time being. So I would think private placement remains an option."

Cash Infusion for CIRM Confirmed

Another report surfaced this morning, confirming that the California stem cell agency will be among the beneficiaries of the sale later this month of $3 billion to $4 billion in taxable state bonds.

Rich Saskal of The Bond Buyer wrote that the state of California plans to use a portion of the proceeds "to provide forward funding for taxable bond programs, such as affordable housing and stem cell research."

The news came as a bit of a surprise to some members of CIRM's board of directors that we queried. The agency itself and the treasurer's office have not yet responded to our inquiries, which is not unexpected since they went out overnight.

The stories in Bond Buyer and the Los Angeles Times did not specify how much cash is likely to be forthcoming for CIRM, which would have run out of money next fall without additional funding. Bonds are virtually the only source of cash for CIRM's operations and grants.

Cash Crunch Coming to an End at CIRM?

No official word is out yet, but the financial woes of the California stem cell agency are likely all but over.

According to a report late today by Tom Petruno on the Los Angeles Times website, within the next two weeks state Treasurer Bill Lockyer will try to raise up to $4 billion in a taxable bond sale that would bail out CIRM.

Petruno wrote,

"Part of the offering will be used to finance projects that don’t qualify for tax-free funding -- such as the stem-cell research measure that California voters approved in 2004."

The California stem cell agency is dependent on California bonds for its grants and operations. But bond sales dried up last year. And CIRM will run out of cash by next fall unless it receives more funding from bonds.

Petruno explained that the proposed $4 billion bond sale is unusual. He wrote,

"(State Treasurer Bill) Lockyer will use taxable bonds instead because the U.S. Treasury will pick up part of the interest cost of the securities.

"Under the Build America Bond program, states and other municipal issuers can choose to sell taxable bonds for public-works projects and have the federal government pick up 35% of the annual interest expense on the securities."

If bond funds are coming to CIRM, that could mean that it will give up its plan to market taxable state bonds privately, which would be an unusual and difficult chore.

No announcements have been made by CIRM or the treasurer, but Petruno sourced his story to a spokesman for the state treasurer's office, Tom Dresslar. We are querying the agencies concerning the Times report.

Patient Advocate Reviews CIRM

Perspectives on California's stem cell effort can vary widely. Here is a view from patient advocate Don Reed, who is regular attendee at CIRM meetings and an officer in the private stem cell lobbying group created by CIRM Chairman Robert Klein.

Some excerpts from a recent entry on his blog, stemcellbattles.com, entitled "A Year in the Life of the California Stem Cell Program:

"In the midst of all the economic gloom and doom, something shining has emerged in California: the beginning of a vastly better world."

"Look at the path that CIRM has laid down for cure: educating and supporting scientists, helping train their support staff, setting up loans for the companies that will risk so much to develop products for patients… this is something which should be shared, and imitated."

"It is not enough just to labor endlessly—everybody wants results. As (CIRM) President Alan Trounson puts it: 'I tell my colleagues here at CIRM probably at least once a week: 'We are in a hurry; we have a short time frame, and we need to get genuine cures to Californians.'"

Niche Links to CIRM Articles

Nature magazine's stem cell blog, The Niche, has a rundown and links to various pieces concerning the status of the California stem cell agency.

Monya Baker wrote,

"The leadership and governing structure of CIRM have come under a lot of criticism. Its 29-member board is politically appointed and must include patient advocates as well as high-ranking officials from the institutions most likely to receive CIRM funds. Its plans to give loans and grants to companies have been called both essential and overambitious. The agency has also been praised for taking a leadership role in drafting guidelines and for helping to maintain a U.S. pipeline of stem-cell scientists. "

The Cartography of Stem Cell Science

The global reach and aspirations of the California stem cell agency are the subject of some legitimate debate and criticism.

On one hand, the agency has severe financial problems and will run out of money by next fall unless something changes in its cash position. It has approved nearly $700 million in grants including an ambitious lab construction program, which require attentive monitoring. And CIRM is continuing to hand out tens of millions of dollars in grants. All of this with less than 40 persons on its staff, and all of which leads some to say the agency needs to stick to its knitting.

But at the same time, stem cell science is hardly confined to the borders of the Golden State. Hot stuff is happening across the nation and globally. CIRM's leadership wants to leverage its position and build scientific and financial alliances throughout the world with the goal of pushing science along a bit faster.

Out in Minnesota, William Hoffman has captured the global stem cell picture in a way that words cannot. Co-author of "The Stem Cell Dilemma," he has been charting stem cell science since 2003 on a map of the world. The changes in that picture have been dramatic. He recapped them on Friday on the Bioethics Forum.

Hoffman wrote,

"To this layman, one of the most baffling things about the (the stem cell) debate here and the reaction to President Obama’s executive order is the near total inability of some leading critics to see the 'big picture' that the maps help to illustrate."

Some stories are best told in words. Some with numbers. Hoffman has demonstrated the the global spread of stem cell science may be best told with the tools of a cartographer.

Here is a link to the World Stem Cell Map website.

Angell, Corruption and Medical Research

The former editor in chief of the New England Journal of Medicine weighed in on the “smell of corruption” in medical research earlier this year in a piece that has some implications for the California stem cell agency.

Writing in the New York Review of books on Jan. 15, Marcia Angell(see photo), now a senior lecturer at the Harvard Medical School, said,

“After much unfavorable publicity, medical schools and professional organizations are beginning to talk about controlling conflicts of interest, but so far the response has been tepid. They consistently refer to ´potential´ conflicts of interest, as though that were different from the real thing, and about disclosing and ´managing´ them, not about prohibiting them. In short, there seems to be a desire to eliminate the smell of corruption, while keeping the money. Breaking the dependence of the medical profession on the pharmaceutical industry will take more than appointing committees and other gestures. It will take a sharp break from an extremely lucrative pattern of behavior. But if the medical profession does not put an end to this corruption voluntarily, it will lose the confidence of the public, and the government (not just Senator Grassley) will step in and impose regulation. No one in medicine wants that.”

That was Angell´s conclusion after a lengthy exploration of the links between drug companies and researchers. As for CIRM, it has a raft of issues involving conflicts of interest and is now on a course that will link it ever closer to industry.

The question is whether the state agency will become the handmaiden of biotech – in effect captured by the industry. The agency should and must work with industry. But business has much different primary objectives than any state agency. Profits must come first for any business. Otherwise, they will cease to exist. In the case of CIRM, its first responsibility is to the people of California. And as we are now seeing on the national scene, the paramount interests of business have not necessarily served the people well.

Angell´s article is a well-documented look at how the people who pay the piper call the tunes. It is well worth reading along with a Feb. 26 exchange in the letters column with some of the folks identified in her piece.

(Editor´s note: We came across the Angell piece in an odd fashion. We discovered it in a pile of old boating magazines, romance novels and mystery potboilers at an informal book exchange for sailors in Mazatlan. Her article is certainly not the regular sort of reading for most of the salty dogs of the sea.)

Time Now for CIRM to Let Sunshine In

California Gov. Arnold Schwarzenegger today set a fine example of openness – one that should be emulated by the California stem cell agency.

His action follows by one day another sterling case of transparency – this one involving a member of the board of directors of the California stem cell agency, Philip Pizzo(on right), whose main job is running the Stanford School of Medicine.

Both men acted to maintain and bolster support for important societal institutions at a time when public confidence in our leaders has been sadly eroded.

It took a bit of a scandal -- disclosed by the Los Angeles Times -- to force the governor to make his move. But today, Californians can check out for the first time online the economic interests of the top state executives appointed by Schwarzenegger. They can also view the officials´ monthly travel expense reports. (The information is a public record, but has not been easily accessible previously.)

The governor put the material online after Michael Rothfield of the Times reported that several top members of his administration charged taxpayers thousands in airfare, hotel and meal costs with little oversight. Two members have since left.

In announcing the new online information, the governor said,

“Since taking office I have taken steps to make government more accountable and responsive to the people. By making the economic, gift and travel information of the senior members of my administration easily available online, we are taking unprecedented steps to open up our government to the people – yet another critical step toward more government transparency.”

On Wednesday, Pizzo announced that Stanford will be posting online “the medical- and research-related consulting activities for some 1,200 physicians and faculty affiliated with the medical school.”

Pizzo, dean of the medical school, said,

"Industry collaborations are critical to furthering research efforts and innovative patient care, but at the same time, concerns over these activities are eroding the public trust. I hope that steps to increase transparency will resonate with those we serve, educate and work with — and reinforce that trust."

The Stanford medical school has been in the forefront of moves to increase transparency in medical research. In 2006, Stanford physicians were barred from ”accepting biomedical industry gifts, including drug samples, anywhere on the medical center campus or at off-site clinical facilities where they practice,” the school says.

The California stem cell agency has promised the highest standards of openness and transparency. In some ways, it is quite open. But it is an agency that was constructed with huge built-conflicts. Its board of directors is dominated by folks from the institutions that have been the chief beneficiaries of CIRM´s largess. As of last October, 18 institutions with representatives on the board (past and present) had received $552 million in CIRM grants.

The political reality is that the structure of the agency is not going to change. Given that fact, it behooves CIRM to lay all its cards on the tables. At least that way, the public knows who stands to benefit from the billions CIRM is giving away at a rate of $24,000 an hour.

CIRM should make the statements of economic interests from its directors and top officials available online in easily searchable and downloadable databases along with their travel and other expenses.

The agency should also disclose the economic interests of its scientific grant reviewers. Although they make the de facto decisions on grants, the reviewers´ statements of interest are withheld from the public and the scientists who are the subject of their scrutiny. That is a situation that naturally generates suspicion, especially since their deliberations are conducted behind closed doors.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., wrote about the Stanford action on his organization´s blog. Simpson called for more disclosure from CIRM. In a comment to the California Stem Cell Report, Simpson said,

“Bob Klein (CIRM chairman) talks about transparency. He ought to do something about…. Working group members aren't required to file any public disclosure now and that is outrageous. If the governor can post monthly travel reports, so can the stem cell agency. Doing less means that claims of transparency are nothing more than empty rhetoric.”

CIRM is currently a bit strapped for cash, but the governor´s office has already done the hard work of setting up online templates for the disclosure statements. It would take little more to fill in the information.

Evidence of public´s current disenchantment with our leading institutions can be read and heard every day. CIRM can help to restore confidence by following the governor´s lead. CIRM will also help itself by acting in a way that demonstrates its responsiveness to concerns about its conduct and openness.

Comments on the California Stem Cell Report

Late last night, an anonymous comment was posted on this site that contained deeply, deeply offensive language concerning President Obama.

I removed the comments today within minutes of learning of them. I apologize for their appearance and profoundly regret their presence on this website. The comments had no place on this blog or in the discourse about the events in our country.

I also want to share with our readers the current state of the ¨comment¨ function on the California Stem Cell Report. A few years back, I began with un-moderated comments. But libelous and offensive anonymous postings appeared concerning one of the spouses in a marital dispute, who happened to be involved in the stem cell business. As a result, I began moderating comments.

Virtually all of the comments since then have been civil and within the bounds of reasonable discourse. A few amounted to spam. Moderation allowed me to prevent them from ever being posted.

A week or so ago, I removed moderation in hopes of stimulating additional commentary and dialogue. A couple of spam items surfaced and were removed. Then this latest ugly comment came in.

I believe it is an aberration and do not want to let the hate-mongers stifle public debate. So I am going to continue un-moderated comments, at least for the time being. My policy is to allow virtually all comments with the exception of offensive or obscene statements such as the one posted last night. I believe that robust criticism of this blog, its writer as well as others involved in California stem cell matters is to be encouraged. Libel and spam, of course, are not okay.

If you have any thoughts on all this, you can post them as comments by clicking on the word "comments" at the end of this item or you can send them to me privately at djensen@Californiastemcellreport.com.

Novocell Patents and Potential Profits

The latest developments involving Novocell, a San Diego, Ca., firm, and its stem cell patents are explored today in a piece by Terri Somers in the San Diego Union-Tribune.

She reported that the privately held firm "may have found new ways to make money from its technique for coaxing human embryonic stem cells into insulin-producing pancreatic cells." Somers recapped Novocell's patent picture and reported that the company announced on Tuesday that it "received a patent that essentially gives it control over all endoderm cells made from human embryonic stem cells."

She quoted Liz Bui, Novocell's director of intellectual property, as saying the firm hopes to collaborate with larger firms that have previously shied away from stem cell research.

Somers also noted the broad nature of the Novocell patent. She wrote:

"Many patents are for a method, or scientific process for making something, sort of like a high-tech recipe.

"The patent Novocell received is for composition, meaning it is not for how to make the endoderm cells, but the actual cells 'the product of the recipe.'"

She said that such patents have been controversial, citing the example of those held by Jamie Thomson of the University of Wisconsin. Some have argued that the patents on Thomson's work are so broad that they impede science.