Correction

The “Research Standards” item Oct. 11, 2009, incorrectly said the regulations will be considered Oct. 16 by the CIRM board. The regulations will come before the board Oct. 27-28.

CIRM Stem Cell Education Bill Signed into Law

California Gov. Arnold Schwarzenegger has signed legislation aimed at promoting stem cell science and training in the state's schools.

The legislation was backed by the California stem cell agency and requires, among other things, that the state Department of Education post a CIRM model curriculum on department's web site.

The measure (SB471) by Sen. Gloria Romero, D-Los Angeles, and Senate President Pro Tem Darrell Steinberg, D-Sacramento, originally would have required the state Board of Education “to incorporate stem cell science curriculum content and the science curriculum framework, evaluation, and instructional materials at its next curriculum revision and adoption and requested the U.C. Regents to consult with various entities in developing a curriculum for the California State Summer School for Mathematics and Science. “

The bill goes into effect next year. You can find the latest legislative staff analysis here and the text here.

Congressional Bill on hESC Research

A Colorado congresswoman is planning to introduce legislation to codify the president's executive order permitting federal funds to be used for human embryonic stem cell research and to require periodic review of NIH research guidelines.

The Washington Post reported during the weekend:

“Usually, couples who go to in vitro fertilization clinics create more embryos than will be implanted. The remainder are either destroyed or frozen. The NIH regulations and the bill would allow couples to donate their embryos for research as long as they are fully informed of their choices and they are not compensated for the embryos. The guidelines give donors the ability to change their minds 'until the embryos were actually used.'"

The newspaper continued:

“Congress already prohibits federal funding for collecting stem cell lines from human embryos, which are destroyed in the process. But the NIH rules make it clear that taxpayer money will not be used on lines from embryos created solely for research.”

Rep. Diana DeGette, D-Colo., plans to introduce the measure soon, according to the Post. The CIRM Standards Working Group meets this morning to consider revising California regulations to achieve consistency with federal rules.

California Chief Justice Rips State's Initiative Process

First it was Bill Gross, and then came Ronald George.

Neither name is a household word, but they do have a cachet in certain circles.

Gross is head of a $178 billion bond fund (Pimco Total Return) based in Southern California. George(see photo) is chief justice of the California State Supreme Court.

What they have in common this month is their public scorn for the state's ballot initiative process, the method used to create CIRM and which lies at the root of the some of the problems that regularly trouble the California stem cell research agency.

George's remarks surfaced during the weekend in both the New York Times, Los Angeles Times and The Sacramento Bee, among other news outlets. His comments followed an earlier blast by Gross that the government of the Golden State has been “perverted” with many of its financial difficulties stemming from ballot initiatives.

In the case of Ronald George, Jennifer Steinhauer of the New York Times described his comments as a “rare public rebuke of state government and policies delivered by a sitting judge.” She said George “scathingly criticized” the initiative process, declaring that it has “rendered our state government dysfunctional.”

George noted that ballot initiatives not only foul up California's budget but tinker with how barnyard creatures are managed. Steinhauer wrote:

“The state is unusual, he said, because it prohibits its Legislature from amending or repealing many types of laws without voter approval, essentially hamstringing that body — and the executive branch.”

The chief justice could have added that CIRM has fallen prey to the same problem. Prop. 71, the ballot initiative that created the agency in 2004, has handcuffed the $3 billion California stem cell agency in dealing with the problems created by its ill-conceived, super-majority quorum requirements as well a redundant limitation on the size of CIRM staff.

Legally, the number of CIRM employees cannot exceed 50, probably about the number of persons needed to run a 24-7 Burger King. That amounts to one CIRM employee to deal with every $20 million in grants expected to be approved by the end of this year. That doesn't count another $2 billion to be awarded in the next five to 10 years.

George noted that ballot measures – originally intended to empower the people – have become tools of special interests. Last year, the Center for Governmental Studies in Los Angeles, documented the range of problems in a 402-page study calling for changes in ballot initiatives. It said that Prop. 71, which established CIRM, is an example of an initiative sponsored by “wealthy elites.”

The timing of George's speech and its handling by his representatives seems interesting as well. The speech was delivered Saturday in Cambridge, Mass., to the American Academy of Arts and Sciences. But advance copies were placed in the hands of reporters at the Los Angeles and New York Times and The Bee in sufficient time for stories to be written and published before it was actually delivered.

It is undoubtedly no coincidence that the placement occurred just before hundreds of persons convene this week in Sacramento for a conference on state constitutional reform, which is what it will take to correct the abuses in the ballot initiative process.

CIRM Acts on Revised Research Standards This Week

The California stem cell agency Monday takes up changes in its research standards aimed at achieving consistency with national rules for human embryonic stem cell research.

The changes appear to be non-controversial although researchers and other interested parties would be well-advised to listen in on the audiocast proceedings of the 10 a.m. meeting of the Standards Working Group. Its discussions often shed light on questions that may pop up later when the standards are to be applied.

If you can't tune in, CIRM has posted the regulations along with additional details and the Powerpoint briefing slides to be used at the meeting. The documents are also necessary if one wants to follow the audiocast.

The rules being considered by CIRM apply only to research that is funded by the agency. Stem cell research in California that is not funded by CIRM is regulated by the state Department of Health.

From day one, CIRM has banned the use of stem cell lines if they are derived in a process that provides compensation – “valuable consideration” – for eggs or embryos. One of the proposed changes that caught our attention involves an exception to the ban on “valuable consideration” in the case of embryos created in reproductive IVF. The proposed rule states:

“For embryos originally created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose 'valuable consideration' does not include payments to original gamete donors in excess of 'permissible expenses.'”

Having watched laws and regulations formulated for several decades as a journalist, creation of exceptions piques my interest. In this case, I wondered whether money could be made by using the proposed exception. What happens if human eggs have real economic value at some point in the future in terms of research i.e. a high demand and a supply shortage? Is it possible that crafty entrepreneurs could use the cover of IVF to generate eggs to meet that demand?

CIRM firmly believes that will not happen under its proposed rules. Their intent is clear plus CIRM also reviews its grantees' research protocols and audits the institutions, the agency says.

We also asked Hank Greely, a Stanford law professor familiar with stem cell issues, about the matter. Greely, who is not involved with the CIRM regulations, offered this quick and informal response that basically supports the CIRM regulation.

“I think that's a defensible interpretation. She is being paid to 'donate' ('paid to donate' is odd wording, in itself) her eggs for reproductive purposes. She cannot be told, in advance, that not all of her eggs will be used to make embryos for reproductive purposes, because no one knows, in advance, how many eggs she will provide, how many embryos will thrive, and how many the recipient will need for reproductive purposes. She doesn't get any money because of the research use and she doesn't 'donate the eggs for research use' - the woman/couple who pay her for her eggs ultimately donate the embryos made from those eggs for research use. The egg donor gets the same amount of money whether the recipient ends up using all of the embryos created with the donated eggs for reproductive use or none. No more or less money changes hands depending on whether all the eggs are used for reproduction or some of the eggs are used for research.

“Assume I pay you $3 for a six pack of Coke Zero and I tell you I plan to drink as many as I need, which may or may not be all of them. I end up giving one of the cans to my wife. Have you received 'valuable consideration' for donating the can to my wife?”

For an earlier discussion of the regulations, you can see the transcript of the standards group meeting on Sept. 18.

Directions for hearing the audiocast can be found on the standards group agenda.

(Editor's note: An earlier version of this item incorrectly said that the proposed regulations will be considered by the CIRM board Friday. They will be heard by the board at its meeting in Los Angeles Oct. 27-28.)

California Treasurer Says Stem Cell Agency to Receive $118.5 Million

The California State Treasurer's office this afternoon confirmed that the California stem cell agency will receive $118.5 million in fresh cash from the state's latest bond sale.

It was good news for CIRM, which faced the prospect of running out of money by the end of next year, and a change from what was expected earlier this week.

Tom Dresslar, spokesman for the treasurer, verified the figure in a phone interview. He also confirmed the accuracy of an Oct. 7 item, “No New Stem Cell Cash,” on the California Stem Cell Report, in which he was reported as saying that no additional funds were expected.

Dresslar said his comments were reported accurately at the time, but the treasurer's office subsequently decided to allocate the cash to CIRM.

For comments from CIRM on the results of the bond sale, see the “recent comments” column to the left of this item.

CIRM Says It Is Receiving More Cash From Bond Sale

We would like to call attention to a comment posted this afternoon by CIRM on this site declaring that the information contained in our item, “No New Stem Cell Cash,” is incorrect. Our piece reported that the state treasurer's office said that CIRM would receive no new cash from the latest California bond sale. CIRM disputes that information. We are checking with the treasurer's office concerning the item and the comment by CIRM's Don Gibbons, the stem cell agency's chief communication officer. You can read his comment by clicking on it at the left of this posting. Or you can find it by clicking on the word “comments” at the end of the original item.

No New Stem Cell Cash in Latest California Bond Sale

California's sale of $4.5 billion in bonds this week will not mean fresh cash for the California stem cell agency.

In response to a query, Tom Dresslar, spokesman for the state treasurer's office, said some of the proceeds will go to refinance earlier debt taken on to support the state research operation. But he said no additional funds will go to CIRM.

The agency currently has enough cash to operate roughly through the end of next year. Its sole source of any significant revenue is California state bonds.

The agency experienced a cash crunch earlier this year and raised the possibility of marketing state bonds privately. CIRM, however, received a $505 million infusion in April as the result of a $7 billion California bond sale.

Presumably the agency will be in line for some additional bond funding between now and December 2010.

CIRM Panel Approves $300,000 Economic Study; Public Access to Data Still a Question

A subcommittee of the directors of the California stem cell agency today unanimously approved a $300,000 economic impact study of the agency's work by a firm that is expected to “execute a vibrant and aggressive strategy” supporting CIRM.

Still up in the air is whether CIRM will allow other researchers and interested parties access to the basic data that will be gathered for the study at taxpayer expense. Much of the information will come from recipients of CIRM grants.

In response to an email query, Don Gibbons, spokesman for CIRM, said the Governance Subcommittee approved the study to be conducted by LECG of Emeryville, Ca. Gibbons did not respond directly to questions about whether the data would be available to other, non-CIRM researchers, who could make an independent assessment about the financial impact of spending $3 billion for research.

Gibbons looked askance at an earlier item on the California Stem Cell Report that discussed the issue of public availability of the information.

He said in an email that the article was “grabbing at straws.” The item was based on a brief response from Gibbons to two questions from the California Stem Cell Report. Gibbons said that he was “in a hurry” when he looked at our emailed questions and misread them as a request for a copy of a contract. (Our two sentence request can be found here.)

Gibbons added that at the Governance meeting, CIRM Chairman Robert Klein “pledged that the (economic analysis) model created will be made public,” a statement that raised another question from us.

We asked Gibbons,

“To double-check, your message....omits any reference to making the basic data public. The 'model' is different than the data used in it.

“Will the basic data be available to the public and will it be available in a non-proprietary format? Thanks.“

Gibbons' verbatim response:

“The bulk of their work will be on the model. The only case that will be worked through with full data will be the test case on Polycythemia Vera. There will be some data that will be protected by patient privacy laws. We have not worked out where that line will be drawn.”

CIRM's position falls far short of ensuring public and researcher access to the basic data, which is being generated with taxpayer funds. Bringing up patient privacy laws only confuses the issue. In virtually all major studies of this sort, individual names and personal information are not important to the analysis. The data are aggregated in an anonymous fashion.

The important point is to build a database from the very start that is publicly usable and that does not co-mingle confidential and public information in such a way that harms its public accessibility. If the two categories are interwoven inappropriately, it could make the data nearly impossible to unwind.

To fail to ensure public access to the basic information only damages CIRM's credibility, especially when the agency goes to Sacramento seeking additional funding. Klein has promised to adhere to the highest standards of openness. It is time for him to fulfill that promise.

As for the independence of the winning firm, CIRM's request for bids specifically stated that a successful bidder must “execute a vibrant and aggressive strategy to support the goals and initiatives of CIRM.”

More Locations for Economic Impact Meeting

If you are eager to participate in this morning's CIRM meeting involving a $300,000 economic impact study, the stem cell agency has added several new teleconference locations, including Des Moines.

Here is the latest list of locations for the 11 a.m. PDT session in addition to Des Moines: San Francisco (2), Palo Alto, Los Angeles (2), UC Davis and Irvine,

Specific addresses can be found on the agenda. Some of the locations do not have room numbers. CIRM should be able to provide them at 415-396-9100.

Will CIRM Withhold Economic Data?

The California stem cell agency today left open the possibility that the basic data gathered during a proposed $300,000 economic impact study will be withheld from the public and outside researchers.

The question of whether CIRM considers the information a public record arose in connection with the proposed contract with LECG of Emeryville, Ca., which comes before the CIRM directors' Governance Subcommittee during a teleconference meeting Tuesday.

Earlier today, we pointed out that none of the CIRM documents currently available on the proposed study provide assurances that the basic information, which will be gathered at taxpayer expense, will be considered open to the public and made available in a non-proprietary format.

We asked CIRM in an email,

“Will the data gathered under the economic impact study proposal to be considered tomorrow be public record? Will it be available in a non-proprietary format?”

Here is the verbatim response from Don Gibbons, CIRM's chief communications officer.

“We don’t quite have a final contract yet.”

CIRM's best interests would be well served in being very explicit that the data are public. The agency holds an unprecedented position in state history and is engaged in activities that reach deep into the scientific community, academia and the biotech industry. To draw a curtain over information that would allow truly independent study of CIRM's impact would be a disservice to California taxpayers and to those who would study CIRM in the future.

Just as scientists test the results of research by attempting to replicate published results, it is only appropriate to apply the same standard in the case of the CIRM economic study. That means that the basic data must be available to all researchers or interested parties, not just those consultants hired by CIRM.

CIRM Moving Forward with 'Vibrant' Economic Benefit Study

Key directors of the California stem cell agency tomorrow are likely to give the go-ahead to a $300,000 proposal to study the economic impact of its $3 billion research effort.

Under the terms of the RFP, the folks doing the study must “execute a vibrant and aggressive strategy to support the goals and initiatives of CIRM.”

Five firms responded to the RFP last year. Only one, LECG of Emeryville, Ca., is being considered tomorrow at a teleconference meeting of the directors' Governance Subcommittee. LECG says Henry Miller of its Washington, D.C., office and Jose Alberro will be co-directors of the study.

We have written previously about the credibility problems associated with any economic study funded by CIRM. There is no doubt that CIRM's efforts have a beneficial economic impact. But no CIRM-financed study will convince skeptics that the program is necessarily justified.

Nonetheless, CIRM is proceeding with the effort, which will undoubtedly be a useful public relations tool. The study is also likely to be served up at some point to support the need for additional state funding. And it could serve as a marketing device should CIRM push forward with its plans to peddle state bonds privately.

If the data are public record and available in a non-proprietary format, they could be useful to other economists and interested parties. Most of CIRM's records are public, but sometimes some of its important information is tucked away from the public gaze. The RFP, the LECG bid and the staff report carry no assurances that the information gathered during the study will be available publicly or in a format that could be used by non-CIRM researchers.

We have asked CIRM whether the economic data will be a public record and will carry the agency's response when we receive it.

The RFP for the study was first posted about a year ago, but is no longer available on the CIRM Web site. A CIRM staff report said that negotiations on the contract were suspended because of concerns about CIRM's financing.

The report said that contract being considered tomorrow will involve something of a pilot project. The staff said,

“The plan agreed upon between CIRM and LECG is to initially build a model around a test case, a specific disease – Polycythemia Vera – that is the target of a clinical trial under the direction of Dr. Catriona Jamieson at UCSD (the topic of a disease “spotlight” at the June 2009 ICOC meeting in San Diego). This clinical trial involves a small molecule drug therapeutic identified through studies using stem cells. The model will take into account direct benefits of CIRM funding (job creation through research and facilities awards), secondary cascades of CIRM funding (“multiplier effect” – e.g. payments to suppliers and subcontractors along with affiliated job creation and state revenues from income, sales and property taxes), potential savings in health care costs (compared to current therapies) and increased productivity for both patients and their caretakers (related to improved vitality and quality of life). Once this model is created, it will be evaluated and fine-tuned by a panel of experts selected by LECG and CIRM. The application to Polycythemia Vera will then be completed and a report prepared by December 2009.

"Subsequently, the model will be expanded and adapted for analyzing other diseases and other applications of stem cells for treating these diseases. In addition to the development of small molecules, other approaches will include cellular therapies (replacing cells, organs &/or organ functions) and the creation of normal and disease specific cell lines for screening (e.g. predictive toxicology) and early diagnostics. The entire project should be completed by the beginning of May 2010. Further, we expect the results to identify data that CIRM should collect on an on-going basis as part of its grants management process for use in future economic analyses.”

The other firms offering bids for the economic RFP included the Analysis Group, which previously performed studies for CIRM and the Prop. 71 ballot campaign. The others were RiskAnalytica, PricewaterhouseCoopers and Tripp Umbach.

The public can take part in the teleconference meeting at locations in San Francisco (2), Palo Alto, Irvine, Los Angeles and UC Davis. Specific addresses can be found on the agenda.

Prop. 71 Fallout: Bond Guru Assails California Voter Initiatives

Bond maven Bill Gross kicked off October by lashing out at California's “perverted” form of government including ballot measures such as Prop. 71, which he said have have “almost tragically shaped” the state's laws.

Gross made his remarks in his monthly commentary, which is widely followed in the financial community. The Southern California resident is the head of the $178 billion Pimco Total Return Fund. He is also a backer of stem cell research at UC Irvine to the tune of $10 million.

For those of you not familiar with ballot measures, Prop. 71 is the voter initiative that created California's $3 billion stem cell agency, which uses borrowed money to finance scientific research for the first time in the nation's history.

Gross deplored the current financial state of affairs in California, which he likened to dog excrement. He wrote:

“Perhaps more than any other state, California has been affected by its perverted form of government, requiring a two-thirds vote by state legislators to effectively pass a budget. In addition, the state’s laws are almost tragically shaped by a form of direct democracy more resemblant of the Jacksonian era, where the White House furniture was constantly at risk due to unruly citizens, high on whisky, and low on morals and common sense. Propositions from conservatives and liberals alike have locked up much of the budget, with Proposition 13 in 1978 reducing property taxes by 57% and Prop. 98 in 1988 requiring 40% of the general fund to be spent on schools.”

Gross continued,

“What is critical to recognize is that both California and the U.S., as well as numerous global lookalikes such as the U.K., Spain, and Eastern European invalids, are in a poor position to compete in a global economy where capitalism is morphing from its decades-long emphasis on finance and levered risk taking to a more conservative, regulated, production-oriented system advantaged by countries focusing on thrift and deferred gratification.”

Prop. 71 is just one of the ballot measures that California voters have approved over the years, although its impact ($6-$7 billion with interest) is tiny compared to the examples that Gross cited.

Nonetheless, government by ballot measure is a poor way to regularly do the people's business. Indeed, one of the chief obstacles to the smooth functioning of the stem cell agency is, in fact, the ballot measure that created it. Like some smothering parent, Prop. 71 effectively prevents the agency from making much-needed changes in its operations, ranging from removing the poorly conceived 50-person staff limit to changing its super-majority quorum requirements, which continue to make it difficult for its board of directors to do business. The board's own attorney earlier this year declared that CIRM is handcuffed. He said that it is impossible for the board or the legislature to make important reforms (see the the Little Hoover Commission findings) without going to another vote of the people, an exceedingly unlikely event, short of a major scandal at the stem cell agency.

(Editor's note: An earlier version of this item did not contain the reference to Gross' $10 million contribution.)

CIRM Looking for Closer Conformity on Egg Rules

SAN FRANCISCO --As part of its effort to achieve consistency with national standards, the California stem cell agency is moving towards allowing the use by CIRM researchers of embryos created through IVF that originally involved payments.

The CIRM Standards Working Group last week approved the move although specific language is yet to be worked out. Bernie Lo, co-chairman of the group and director of the medical ethics program at UC San Francisco, said the language would be narrowly focused.

Jesse Reynolds of the Center for Genetics and Society of Berkeley, Ca., said he was
“encouraged” by the CIRM direction. Earlier, the group had expressed concern that CIRM might be creeping towards possible creation of a loophole in the Prop. 71 ban on compensation for egg donors.

CIRM hopes to present specific language soon for its proposed rule to the Standards Working Group in a telephonic meeting. The proposal would then go to the CIRM board and from there into the official state regulation process.

In other matters involving the standards group, Alta Charo, a professor of law and bioethics at the University of Wisconsin, who has been a member of the group since its beginning in 2005, is leaving the panel because of her new position as a senior advisor at the FDA,

CIRM hopes to approve a replacement at the board meeting that begins Oct. 27.

Reynolds also praised CIRM staff for the early posting of background material on matters to be discussed at the meeting last week. Additional material has been posted as well on the research standards issues facing CIRM. It all can be found here.

Germany Added to CIRM's Stable of Partners

The California stem cell agency today announced its sixth international agreement – this one with Germany – with the hope that it will lead to joint research in stem cell transplantation and immunology.

The agreement is intended to make it easier for researchers in California and Germany to obtain joint funding. As with the other agreements, no California funds are permitted to be spent outside of the state.

CIRM already has agreements with organizations in Canada, the state of Victoria in Australia, Japan, Spain and the United Kingdom.

CIRM's news release quoted California Gov. Arnold Schwarzenegger as saying,

“There are brilliant minds all over the world, especially here in California, and with collaborations like this we can help ensure that potentially life-saving breakthroughs can come more quickly and more often.”

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

“We have over $60 million in commitments from our international collaborative funding partners.... There were a total of nine collaborative applications in the Disease Teams, with Canada, Spain and the UK represented, but of course we won’t know how those nine fared among the 31 until October 28(the next CIRM board meeting). There are a number of Japanese collaborations among the Basic Biology 2 awards that have just come in and are being assessed internally now.”

The only international grants awarded so far came last spring in the early translation research round. Four collaborations were funded for a total of $29 million($24 million California and $5 million Victoria) involving Alzheimer’s disease, Parkinson’s disease and techniques for working with embryonic stem cells.

Egg Donor Proposal Stirs Concern; CIRM Says Language is 'Placeholder'

The Center for Genetics and Society Thursday raised “serious concerns” about some of the matters to be discussed at today's meeting of the research standards group of the $3 billion California stem cell agency.

CIRM, however, said the center has “misconstrued the intent of the proposed changes.”

In a letter to CIRM, the Oakland, Ca., organization center referred to preliminary language contained in a briefing paper for the group that dealt with compensation for egg donors, which is banned by CIRM. The draft language, which is intended to conform CIRM rules to others nationally, would “limit the payment restriction to donation of oocyctes provided specifically for research purposes.”

The center said,

“We were startled to see this for two reasons. As you know, both Proposition 71 and California law prohibit paying women to provide eggs for research. This proposed policy would mean that a woman undergoing egg extraction could be compensated or receive other valuable consideration as long as research is not the specifically stated purpose of harvesting her eggs. Diverting eggs for which payments have been made from the reproductive to the research context would be contrary to Proposition 71 and state law.

“We sincerely hope that this is an oversight. We ask the Standards Working Group to reject the proposed language and to clarify that paying women for eggs that will be used for research (beyond reimbursing their expenses) is contrary to law, and will not be done in California.”

CIRM posted a response to the CGS letter on the agency's website. In the response, CIRM referred to National Academy of Sciences guidelines and said,

“The language 'specifically for research' is a placeholder taken directly from the NAS Guidelines. The SWG (standards group) has consistently drawn from the NAS guidelines to provide a model for our regulations. This example is no different. This placeholder language is designed to support policy development. Any proposed regulatory language is subject to SWG review, ICOC approval, OAL review and public comment to ensure the regulatory language is consistent with the intent of the policy.”

Our take? We think CIRM's intent is clear. However, whether the proposed regulatory language achieves that goal is another question. We suspect more artful language will be developed as these proposed changes work their way through the regulatory process during the next few months.

CIRM is to be lauded for posting its 28-page briefing paper well in advance of today's meeting. That allows time for such parties as the Center for Genetics and Society and others to comment thoughtfully on the matters to be considered. It also allows time for CIRM to respond publicly in advance of the meeting. The upshot is likely to be better policy and better regulations and enhance CIRM's image as responsive to the public.

We should also note that the center's letter also raised concerns about the “prospective use for research of paid-gamete IVF embryos could create conflicts of interest for the physician attending an egg provider, and thus put her at increased risk.”

Correction

The “Prop. 71 Minutia” item on Sept. 16 contained a quote that referred to “advice” from the Little Hoover Commission that CIRM should lower its quorum requirements. A draft of the Hoover report contained that recommendation, but it was omitted in the final version. The final report said the super-quorum requirement was “restrictive” and “problematic” but said the problem would be eased by reducing the size of the board from 29 to 15.

Prop. 71 Minutia Stalls CIRM Again

SAN FRANCISCO – The board of directors of the California stem cell agency Tuesday failed to achieve a quorum and was forced to put off action on regulations tied to its ambitious, $210 million disease team grant round, the largest ever in CIRM history.

That means it will be at least another two weeks or more before the board can act on the IP rules that it needs for disease team project. The grants are scheduled to be awarded later this year.

The board has been handicapped for years by its super-quorum requirement, 65 percent of its 29 members. Tuesday, the quorum was 19 but only 18 answered the roll call during the special, teleconference meeting based here. Twenty-one had been expected. Without a quorum, the board cannot take legal action.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said today that problems with quorums are a persistent and important issue at CIRM. Simpson has followed the matter for several years. In one case in 2008, he wrote about how the board “essentially” drafted a member of the audience to raise a quorum.

Commenting today, he said,

“This clearly shows that (the board) has not resolved its nagging problem with mustering a quorum. They should have taken the Little Hoover Commission's (initial) advice and moved to make a simple majority all that is necessary to conduct business. Instead, they insist on a meaningless charade that wasted the time of 18 very busy people.”

The quorum mandate is written into state law by Prop. 71, which created the stem cell agency in 2004. It cannot be changed without a vote of the people or by the legislature. But the latter involves another super-majority requirement, 70 percent of both houses of the legislature and the signature of the governor.

The Little Hoover Commission, the state's government good government panel, earlier this year cited CIRM's problems with achieving quorums. But the CIRM board last month rejected suggestions that the quorum be reduced to 50 percent. It relied on its attorney's opinion that to do so would “undermine” the intent of the voters and would leave the board open to being captured by a minority.

However, super-majority requirements actually facilitate minority dominance of bodies such as the CIRM board. On Tuesday, the absence of one member paralyzed the board. In other cases, a few members have left CIRM board meetings and thus prevented it from taking action. Conceivably, 11 members of the board could control it by simply refusing to attend unless their wishes prevailed.

The regulations under consideration Tuesday dealt with intellectual property requirements. Initially, they appeared to be relatively non-controversial, although CIRM director Susan Bryant, vice chancellor for research, University of California, Irvine, raised anew concerns expressed last July by the University of California (statewide).

Director William R. Brody, president of the Salk Institute, also criticized some of the proposed regulations as “absurd” and suggested that language from federal IP law be adopted. However, others noted that CIRM deliberately moved away from federal law in its development of the regulations over several years.

In the absence of a quorum, CIRM Chairman Robert Klein said the proposed regulations will be taken up later after CIRM director Ed Penhoet, head of the IP Task Force and a co-founder of Chiron, has a chance to discuss them with Brody and Bryant.

The CIRM board also did not act on hiring underwriters (more than one is needed because of potential conflicts of interest) to run its $500 million biotech loan program. The effort is scheduled to begin with the disease team grant round. But the board was told that a very small number of potential borrowers are involved in that round.

Instead of hiring two or more underwriters, John Robson, CIRM vice president for operations, said the lending effort can begin with a pilot project involving one underwriter. He said that it will help the agency develop a better underwriting effort for the directors to approve next year. Following the meeting, Robson said he hopes to conclude a pilot agreement within days.

You can read more on quorum problems, as discussed by Simpson, here, here, here, here and here.

(Editor's note: In an earlier version of this item, the quotation from John M. Simpson did not contain the word "initial" in parentheses.)

Eggs, Donors, NIH Rules and More This Week

For those of you interested in research standards and rules, the California stem cell agency has posted 28 pages of background material for its meeting in San Francisco this Thursday and Friday.

On the agenda is New York's policy that permits compensation for human eggs to be used for research. CIRM does not permit compensation(valuable consideration), but the agency plans to make some changes in its rules to conform to national standards.

Also available via the CIRM web site is briefing material on proposed changes for donor consent requirements and an update on the NIH rules for human embryonic stem cell research, plus more.

CIRM CEO To Gain More Power in Grant Reviews

The president of the California stem cell agency would wield more power in the agency's grant review process under a proposal that was approved by CIRM's Grant Working Group earlier this month.

The proposal, which will probably go before the CIRM board of directors in October, would give CIRM CEO Alan Trounson the authority to pick an “acting” chairman to preside over each grant review session.

Currently responsibility for the reviews lies with the existing position of chairman, which will be eliminated in its current form. That post has been vacant for nearly a year.

Instead two types of chairs will be created. An “administrative” chair would be named to handle chores other than grant application reviews, which are the chief function of the Grants Working Group. The acting chairs would handle the review sessions. The board of directors would retain authority to approve the administrative chair.

The grants group makes the de facto decisions on CIRM grants, which are expected to total $1 billion by the end of the year.