Stem Cell Research Chain Larded With Cash Except for Women Egg Donors

The Wall Street Journal this morning carried an interesting piece on the risk, pain and money involved in the fertility and egg business.

Written by reporter Sylvia Pagan Westphal, the article offers some perspective on the research and economic issues involved in providing eggs for stem cell research – a subject of current interest in the California legislature and with the California stem cell agency.

Here are the first three paragraphs of the article:

"Nichola Grant underwent five in-vitro fertilization attempts the traditional way. First came weeks of daily hormone shots to stimulate egg production, which painfully bloated her ovaries and stomach. Then doctors inserted a needle through her vaginal wall to remove the eggs -- up to 20 at a time, she says -- from her ovaries. On three occasions fertilized eggs were put back in her womb but failed to lead to a baby.

"That was enough discomfort for Ms. Grant, a 34-year-old nurse in Queens, N.Y. She went to Manhattan fertility doctor John Zhang. There were barely any shots -- mostly pills -- and he removed just three eggs. He implanted one in the womb, and she delivered a baby boy in January. 'It was so easy,' she says. 'It's no comparison.'

"Dr. Zhang doesn't claim his method leads to higher pregnancy rates, but he does assert that Ms. Grant's story represents what's wrong with standard operating procedure at fertility clinics. He says the fertility profession is too concerned with drawing lots of eggs from women. The result, he believes, is more pain, a higher risk of complications and a success rate little improved over gentler approaches."

Westphal's piece continues: "'A lot of people realize we're overdoing it,' adds George Inge, a doctor at the Center for Reproductive Medicine in Mobile, Ala. 'We've got to come out with ways so women are not so beat down.'"

The story reports that the IVF business runs about $3 billion a year, according to Debora Spar, a Harvard Business School professor. More than 120,000 women underwent IVF procedures in 2003.

As for the risk of the procedure, the Journal says:

"One of the most serious complications is ovarian hyperstimulation syndrome, or OHSS, a potentially fatal condition in which ovarian tissue leaks fluid into the body cavity. This makes the blood thicker and increases the risk of stroke. Mild OHSS, which brings discomfort but doesn't require hospitalization, occurs in up to 35% of IVF cycles. Moderate to severe forms take place in up to 6% of cycles."

The piece cited the case of one woman who was admitted to a hospital where doctors drained seven liters of fluid over two days from from her abdominal cavity with a needle. Other sources have cited two deaths in the UK.

One of the working assumptions of stem cell researchers is that IVF will provide a lot of eggs that could be used for science. However, should Zhang's procedures become the market standard, that source would dry up. Which brings us to the question of whether women should be allowed to sell their eggs.

At every stage of the egg gathering process, money is being made except by the woman, who provides the critical material, if we are to follow the CIRM model. The clinics, even nonprofit ones, that extract the eggs maintain a margin in excess of costs. Doctors and nurses and other staff at the clinics earn their livings by harvesting eggs. The eggs then are provided to scientists to perform research. The scientists make their living doing this, receiving grants, being paid salaries, possibly enjoying revenues from inventions that require the use of a woman's eggs. The research institutions' coffers and reputations are enriched as well by the stem cell research that requires the use of eggs from a woman who receives no payment. The commercial enterprises that bring the therapies to market stand to make huge sums based on material that has been derived at no cost from a woman, who may or may not know that at the time of donation that a host of people and enterprises stand to gain economically from her donation.

Prop. 71 bars compensation for eggs, and CIRM has approved rules to ensure that women know some of the economic implications of their donations. But they are unlikely to tell donors that the research chain is larded with folks who will make money on something that they are giving away.

Somehow it doesn't seem quite fair.

CIRM Tackles IP Rules for Private Business March 29

The California stem cell agency will begin to develop its share-the-wealth rules for research grants to private enterprise next week as one expert warns of a "chilling effect" if the state gets too greedy.

The note of caution came from David Mowery, professor at the UC Berkeley Haas School of Business.
A press release last Friday from the school said:

"Should intellectual property and patenting laws be tweaked so that a portion of profits from stem cell research goes back to taxpayers and not just into the coffers of universities and biotech companies? Should the state be able to negotiate low prices on drugs or treatments that are eventually developed with Proposition 71 funds?
"'The direct or near-term benefits from such policies are likely to be very small,' Mowery argues. 'On the other hand, the risk of such policies having a chilling effect on licensee interest in intellectual property is likely to be great.'"

The press release continued:

"'To begin tampering with this legislation on the question of stem cell research in order to set up what amounts to a separate set of laws for this new area of research will dramatically raise overhead costs and serve as a drag on innovation,' he says. 'The relatively small amount of money that will be returned to taxpayers will hardly make it worth it.'"

The size of that return – if any – is likely to be lurking among the subjects at a meeting of CIRM's Intellectual Property Task Force next Wednesday (3-29). The primary item on the agenda? "Informational presentations by representatives of granting agencies and the commercial life sciences sector regarding grants to for-profit entities." At this point, that is the most detailed information available on the Web.

The IP Task Force is on a pretty fast track to develop its regulations, so if you want to have your views considered, it would be wise to touch base with the group. The meeting can be heard at five different locations throughout California, but the San Francisco site is probably where the chairman of the task force, Ed Penhoet, will be located.

Other sites are located in Elk Grove, Chico, Irvine and Stanford. The addresses can be found on the agenda.

Altruism Won't Supply Enough Eggs and Other News From UCLA

California Politics Today is back with another item on the California stem cell agency – this time an interview with a UCLA law professor about his view that the lawsuits against CIRM are frivolous and should have been dismissed long ago.

Reporter Marc Strassman spoke with Russell Korobkin, who has recently written written op-ed articles about the lawsuits.

The plaintiffs in case have argued that CIRM is operating outside the "exclusive" management and control of the state. However, Korobkin told Strassman that the "totality of circumstances" within state government, in fact, brings the agency within the control of the state. He also said it is not unconstitutional for voters to create an agency that has built-in conflicts of interests, as does CIRM.

The 36-minute interview, which can be seen on the Web, covered a great deal of ground. Among other matters, Korobkin said he was "not enough of an expert" to say whether Prop. 71 supporters engaged in a bait-and-switch campaign in the 2004 election. He also said women should be paid for their eggs, although he noted that was prohibited by Prop. 71. Korobkin said altruism is not going to generate the quantity of eggs needed for research.

Strassman prepared a written report on the interview, but did not include in his item some of the material that we extracted from the full video.

A Caveat Emptor on CIRM

The headline reads: "California's Proposition 71 may devolve into 'stem cell civil war.'"

But then again it may not, as my onetime boss, George Skelton, then UPI bureau chief in Sacramento and now political columnist for the Los Angeles Times, used to tell me decades ago concerning the use of the word "may."

The headline in question comes from an article by reporter Marc Strassman on California Politics Today.

Strassman has followed Prop. 71 for a very long time, and we are overdue in providing more information on his news and commentary.

Strassman's site is rich with detail about Prop. 71. Here are two sample headlines from his report:

"'Proposition 71 stem cell quagmire deepens as 'egg recruitment' and 'cellular vampirism' issues receive heightened scrutiny" (California Politics Today, November 17, 2005)

"'Stem Cell Wars, Volume 2, Chapter 2: Human Egg Farming--"Can either the free market or altruistic volunteers provide the human eggs needed for hESC research under Proposition 71, or will some form of coercion be necessary?' (California Politics Today, November 20, 2005)"

One of the unique features of Strassman's site is access to his audio and sometimes video recordings of interviews with many of the stem cell players. Strassman does have a skeptical point of view about the California stem cell agency and produces a report that is as much commentary as reporting.

His latest missive carries the headline mentioned in the first paragraph of this story. Strassman's item concludes with the following:

"Given all that's transpired, and been revealed, since California voters bought the deal proposed to them by Robert Klein and his team of lawyers, economists, and bio-medical researchers (largely ones associated with Stanford University), on November 2, 2004, one can only wonder why the ultra-modern bio-medical technology, cutting-edge legal construction, and beyond state-of-the-art organizational structures instantiated in that initiative measure were not more thoroughly subjected to the more ancient, but still relevant, legal and commercial principle of caveat emptor, 'let the buyer beware.'"

Is CIRM the Big Uneasy?

How do some California stem cell entrepreneurs regard the state's $3 billion stem cell agency?

With unease, at least based on comments at a stem cell conference in San Francisco earlier this week.

Generally, speakers spoke approvingly of the efforts by California and other states to fund stem cell research. But they exhibited a decided preference for national funding via the National Institutes of Health, which, of course, has been cut off by President Bush and is threatened by various legislators. At least in terms of embryonic stem cell research.

William Caldwell, CEO of Advanced Cell Technology, of Alameda, Ca., said state funding of embryonic stem research is "not the way to go." He said the California stem cell research funding effort is "the worst of all evils but it is the evil we've got."

Caldwell did not elaborate on his rather dramatic phrasing, but others echoed it in one form or another. Fred Middleton, managing director of Sanderling Ventures, a biomedical venture capital firm in San Mateo, Ca., did not speak directly to Caldwell's comment. But he said there is "not a clear road map" to CIRM funds.

Perhaps we are a bit dense on this, but Caldwell's position is a little difficult for us to understand. Federal funding for embryonic stem cell research is one-tenth of what is proposed in California. The federal spending is subject to the whims of the president and Congress. Federal stem cell research funding also has to battle a host of other worthy and powerful causes for its share of the federal research pie, which is not likely to expand in the near future.

Contrast that to CIRM, which operates almost totally independently from the legislature and the governor. Its funding comes from $3 billion already approved by voters and is not likely to go away. The money is devoted to stem cell research and is not likely to be tapped by other research efforts. And the agency is emulating many of the processes of the NIH, which are already familiar to biotech industry.

Of course, California's program is new and somewhat unpredictable. It is going beyond NIH standards in some regards. Its intellectual property policies may be tougher for private businesses.

In a perfect world, it would be best to have national standards for stem cell research and unfettered federal funding. But the fetters are not likely to come off during the next two or three years. So what is so problematic about California's approach?

Perhaps Mr. Caldwell, Mr. Middleton or others can enlighten us and the readers of this report. They or you may comment, even anonymously, by clicking on the word "comment" at the end of this item. Or you can send an email directly to me, djensen@californiastemcellreport.com, with your preferences on how your response should be handled.

California Should Expect Modest Royalties From Stem Cell Firms

The California stem cell agency is going to give folks a glimpse later this month at its initial thinking concerning the division of spoils from inventions that come about from its grants to commercial firms.

But we already have a suggestion from one interested party that the state's share be modest. Fred Middleton, managing director of a biomedical venture capital firm in San Mateo, Ca., Sanderling Ventures, suggested minimal royalties – something in the 3 percent to 8 percent range. Ten percent would be too high, he said.

He also said the state should not expect a short-term payback on its investment.

Not that any of this is likely to have a great impact in the near future. CIRM has not yet funded a single grant. And it could be some time before it starts considering grants to businesses. However, it would behoove any commercial California stem cell enterprise to weigh in early as the ground rules are being formulated.

Middleton made his comments at a stem cell conference in San Francisco earlier this week.

Demons, Disease and Stem Cells

Nobel Prize winner Paul Berg says that social conservatives are "actively demonizing" some scientists for stem cell research and other work that offends the critics' sensibilities.

Berg, a Stanford University professor who serves as an alternate member on the California stem cell Oversight Committee, made the comment in a speech at a major stem cell conference in San Francisco earlier this week.

Berg said,

"Perhaps for the first time, the threat looms that certain lines of biomedical research could be forbidden, indeed, criminalized. Currently, legislation passed several times in the House and pending in the Senate threatens criminal penalties of 10 years in prison and a $1 million fine for using a procedure that involves cloning a patient’s genetic information in the form of embryonic stem cells. Never mind that this procedure is intended solely for creating a deeper knowledge of the genetic and cellular roots of disease; and, that the procedure is presently the only means for creating patient-specific embryonic stem cells for the treatment of several debilitating ailments. Even more ludicrous, are the same criminal penalties for providing or receiving any therapy if the development of that therapy involved the nuclear transfer technology. Consider the arrogance of withholding possibly life-saving aid from the American public because some members of the Congress are offended by the technology!"

He continued:

"I am concerned that the quality of the science may no longer be the sole or principal determinant in whether a particular line of research would be permitted; rather, theological and ideological pronouncements parading as fundamental ethical and moral values may increasingly take over. Vocal and organized minorities through their political representatives could become a prominent force in defining the boundaries and even the permissibility of scientific research."

Berg said,

"Presently, social conservatives are actively demonizing scientists conducting research on AIDS, reproductive technologies and fetal and embryo development. The call by social conservatives to limit certain lines of inquiry, as now exists for human embryo research, has been to restrict federal funding for the 'offensive' activity."

Berg also suggested that research is entitled to protection under the First Amendment and discussed legal arguments that support that position. He said,

"Abridging (the) implicit right to unfettered inquiry because it offends someone’s religious beliefs or ethical views is in my view no more justifiable than prohibiting press investigations that offend certain constituencies."

Berg spoke at The Stem Cell Meeting in San Francisco on Monday.

$50 Million for CIRM: All But In The Bag

California stem cell chairman Robert Klein says he now has commitments for the $50 million he has been trying to raise to fund grants approved six months ago by the stem cell agency.

Klein made the disclosure to a stem cell conference in San Francisco earlier this week. The next steps will come from the state treasurer's office to formally approve the bond anticipation notes and do the paperwork. An official in the treasurer's office said that process normally takes only a few weeks.

Of course, that assumes normal proceedings. However, it may also be necessary to arrange for some hoopla to recognize the buyers of the notes and maximize their public impact. State Treasurer Phil Angelides, who is seeking the Democratic nomination for governor, also may want to be sure the proceedings enhance his campaign.

With exception of one purchaser, Klein has not identified the buyers. But he has targeted philanthropic organizations. One reason is that the notes will not be repaid if the state loses the lawsuits against the agency. The risk involved means that the notes will carry a higher interest rate than normal state bonds.

Klein discussed the financing in appearances before The Stem Cell Meeting, sponsored by Burrill and Co., in San Francisco. Burrill is a life sciences merchant bank with more than $500 million under management. The conference drew hundreds of participants from across the nation and internationally.

The End to The Stem Cell Meeting

The following comes to you live from The Stem Cell Meeting in San Francisco.

At the end of the day came rhetoric about the culture of death, bald eagles and their eggs and how we all should be able to get along.

The last meeting of The Stem Cell Meeting in San Francisco concluded with a lively panel on ethics in stem cell research. It was heated at times, humorous and informative. But it did not change the mind of a single person (we think).

Following the final panel, the host of the conference, Steve Burrill, head of the firm bearing his name, told the audience the two-day conference was planned to avoid an event where business people talk only to business people and scientists only talk to scientists. And that it was, an interesting cross section of bureaucrats, executives, scientists, religious folks and so forth. Burrill promised another session the same time next year.

We will have more tomorrow on the events at the meeting.

Wisconsin to CIRM: Cough Up Some Cash

The following is coming live from The Stem Cell Meeting today in San Francisco, sponsored by Burrill and Co.

Wisconsin wants a piece of the California stem cell pie.

That's because the California stem cell agency has decided to give its own state 25 percent royalties on any inventions created with CIRM-funded embryonic stem cell research.

Wisconsin is involved because the Wisconsin Alumni Research Foundation has two patents that broadly cover the preparation of embryonic stem cells. Beth Donley, general counsel, Wisconsin Alumni Research Foundation, said that if CIRM stipulates 25 percent royalties for California that requirement amounts to commercialization. And that means WARF wants a payment from California.

How much would that amount to? Speaking during a panel session at The Stem Cell Meeting in San Francisco today, Donley said that licenses start at fairly low rates and mentioned a bottom figure of $75,000. In February of 2005, Peter Balbus, managing director at Pragmaxis LLC, of Glen Ellyn, Ill., estimated that Wisconsin could receive $200 million for $4 billion in stem cell product revenues. However, it is not clear whether that estimate is still valid.

Donley told industry representatives at the conference, sponsored by Burrill & Co., that she had spoken with CIRM officials on three occasions. The last time was on Monday when she told Robert Klein, California stem cell chairman, that the 25 percent royalty provision meant that CIRM was "trading on (Wisconsin) technology to build a (commercial) program." She said CIRM could provide the royalty in various ways. One would be to provide a stream of revenue from whatever California receives. Another would be to build it into grant arrangements with the nonprofit institutions.

Todd Lorenz, chair, Life Sciences and Health Care, Dorsey & Whitney LLP, another member of the panel, said Donley's statement raised the issue of "suffocation of product." The term refers to excessive layers of royalties of as much of 25 to 30 percent that stifle commercialization of therapies. Donley said Wisconsin was entitled to receive payments for use of its products and that the funds would go for research and education.

Warnings about Overhyping Stem Cell Science

The following is coming live from The Stem Cell Meeting today in San Francisco, sponsored by Burrill and Co.

California stem cell chairman Robert Klein is heading a panel called "Stem Cell Politics: Global Strategies for Supporting Research." Michael Werner of The Werner Group has just told the audience that no state in this country is "talking about the kind of money" that is likely to be available in California. The best prospects for significant stem cell research funding are in New Jersey, Maryland and Illinois. Angela McNab, chief executive of the Human Fertilization and Embryology Authority in the UK, warned that the audience that they cannot take public confidence in stem cell research for granted. She said excessive enthusiasm can lead to overhyping benefits and the speed with which they will be produced. She warned that when results are not forthcoming, opponents "will use the hype to discredit the science."

We will have more on the conference later today.

Coming Up

Today we are attending The Stem Cell Meeting in San Francisco sponsored by Burrill and Co. The conference will be discussing the investment environment for stem cell research along with ethical issues, among other things. Topics include "Where is The Money" and "The Business of Stem Cells." We hope to post items from the conference as it occurs, if the opportunity is available. If not, we will post news from the conference this evening (Pacific Standard Time).

No Teleconferencing for Research Working Group Meeting

Earlier this month we reported that some sort of teleconferencing arrangements were in the works for today's meeting of the research working group of the California agency. However, the reference to those arrangements has been stripped from the agenda posted on the Web. We queried the agency about the matter. They responded that teleconferencing is available only for members of the working groups – not the public.

The New, Obscure Run at California Stem Cell Research Guidelines

Belatedly and quietly, another California state agency is looking into ethical standards for embryonic stem cell research. And at its first meeting two members suggested that it might be appropriate to pay women for donating eggs.

The agency in question is the Department of Health Services. Under 2003 legislation by California state Sen. Deborah Ortiz, chair of the Senate Committee, the department was required to develop guidelines for embryonic stem cell research by Jan. 1, 2005, with the use of an advisory committee.

That 13-member committee was not appointed until six months after that deadline. It did not hold its first meeting until Feb. 24 of this year with the only public notice coming on an obscure website within the Department of Health Services.

Lea Brooks, chief of the public information section of DHS, said the department has no plans to notify the public about committee meetings other than by postings on the website, even if individuals request notification. The committee is expected to have two more meetings before concluding its work this fall.

The committee's guidelines affect all embryonic stem cell research in California, except for that financed by the California stem cell agency, which already has approved its own rules. CIRM is constitutionally independent of DHS and and is not required to adhere to the DHS guidelines.

Members of the advisory committee, however, seem to be in agreement on creating guidelines that are consistent with CIRM regulations, based on a somewhat garbled transcript of the Feb. 24 meeting, which was not covered by the media.

However, the ticklish issue of payments for eggs, which CIRM has shied away from, was raised by committee member Elliott Dorff, a professor of philosophy, who, according to the transcript, said:,

"One issue is just simply how realistic it is to expect women to donate their eggs free of charge. That the UCLA Bruins -- I can’t say the law school at UCLA -- every single time, there are ads for women to donate their eggs for purposes of fertilizing other couples. And while the standard used to be $5,000 plus expenses, I’ve seen ads as high as $80,000 for a particular kind of egg. And so one issue that - I mean I understand why the guidelines don’t want to have any exchange over this, but if the case, I’m sort of wondering whether is it at all realistic."

Committee member Gregory Stock also expressed concerned about a ban on remuneration.

The delay in implementation of the guideline law is a matter of some dispute. Questions have also been raised about reported changes in the committee's composition.

Brooks said the law, as originally passed, did not provide funding. However, other sources indicated that the governor attempted to "defund" it in his first budget. Brooks said it took from June 7, 2005, the date of the committee's appointment, until recently to get all members of the committee to agree to serve and to agree on a meeting date.

Another source said one list of committee members was circulated but that it was changed without notifying persons who were on the original list. The implication was that the committee was altered to be less restrictive on research. Brooks said there was only one list.

It is not clear how much privately funded embryonic stem cell research is underway in California. However, Stanford and UC San Francisco both have private grants to build facilities to do privately funded research. The state also has a number of privately funded stem cell companies.

The bulk of the first advisory committee meeting was largely occupied with background briefings and organizational issues, based on the transcript.

The next public meeting may come in May or June with the final session later this year, according to Henry Greely, chairman of the panel. During the interim, subcommittees will work privately to prepare material for the full committee meetings.

Here is the official list of the committee members: Elizabeth Helen Blackburn, Ph.D, Professor, Departments of Biochemistry and Biophysics, University of California, San Francisco; Samuel H. Cheshier, M.D., Ph.D. Neurosurgical Resident, Department of Neurosurgery, Stanford University School of Medicine; Gregory Stock, Ph.D., M.B.A., Director, Program on Medicine, Technology and Society, University of California, Los Angeles; Irving Weissman, M.D.Director and Professor, Institute of Cancer/Stem Cell Biology and Medicine, Division of Neurosurgery, Department of Medicine, Stanford University School of Medicine; Otoniel Martinez-Masa, Ph.D. Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine, University of California, Los Angeles; Fred Gage, Ph.D. Laboratory of Genetics, The Stalk Institute for Biological Studies; Bertram H. Lubin, M.D. President, Children’s Hospital Oakland Research Institute and Director of Cord Blood Program; Bernard Lo, M.D. Director of Program in Medical Ethics, Professor of Medicine, University of California, San Francisco; David Magnus, Ph.D. Director, Stanford Center for Biomedical Ethics and Associate Professor, Department of Pediatrics, Stanford University; Henry Greely, J.D. Professor of Law, Stanford Law School; Radhika Rao, J.D. Professor of Law, University of California, Hastings College of Law, San Francisco; Elliot Dorff, Ph.D. Professor of Philosophy, University of Judaism, Los Angeles; Margaret R. McLean, Ph.D. Assistant Director, Markkula Center for Applied Ethics and Director, Biotechnology and Heath Care Ethics, Santa Clara University.

More information on the committee can be found at this website.

Coming Up

A little later today we will look at the other California state agency that deals with stem cell research issues. Obscure and dilatory seem to be its hallmarks, although its actions could be far-reaching.

The California Stem Cell Trial: 'Purely Political'

If you missed the piece by the UCLA law professor arguing that the California stem cell trial was a waste of valuable court time, you might want to check out a version of it that appeared this morning in the San Francisco Chronicle.

The article was written by Russell Korobkin. He said, among other things:

"So far, the judicial system has been complicit in the use of the courts for purely political purposes. Because the lawsuit clearly lacked legal merit, the case could have, and should have, been thrown out months ago. Instead, an overly cautious Alameda County Superior Court judge told the plaintiffs that, although she found their written arguments unconvincing, she would afford them another opportunity to convince her by presenting evidence at trial."

Penultimate Clashes in the Stem Trial

The almost final arguments in the California stem cell trial have now been filed. Rebuttals are due next week.

Here is part of what reporter Bernadette Tansey of the San Francisco Chronicle had to say about the filings:

"Robert Taylor, an attorney for the taxpayer group People's Advocate, argued that members of the independent committee charged with distributing billions in stem cell grants represent the interests of the universities and disease advocacy organizations from which they are drawn, not the interests of the state at large. But the state prosecutor defending the stem cell initiative said the challengers had failed to produce any evidence at trial to prove their claims. The testimony demonstrated that the new research institute is subject to supervision and control by state authorities including the treasurer's office and the Legislature, wrote Deputy Attorney General Tamar Pachter...."
"The opponents will have a last chance to counter each other's written arguments Wednesday, when final reply briefs must be filed with Alameda County Superior Court Judge Bonnie Sabraw. She will then issue a written ruling, possibly within weeks. But even if the plaintiffs lose, their appeals could take another year."

It appears that Tansey was the only reporter to file a story this morning on the filings, but, of course, that statement has to be qualified by proficiency of the usual search engines, which do not find everything.

Four Stem Cell Biggies Form Consortium

San Diego is on a stem cell roll this week. First it was the public embryo bank – the nation's first ever. Now it is a plan to become the world's epicenter of stem cell research.

Reporter Terri Somers broke both of the stories in the San Diego Union-Tribune. Her piece today said that "four La Jolla research institutes plan to join forces and seek state funding to build a facility for human embryonic stem cell research."

They are the University of California, San Diego, and the Burnham, Scripps and Salk institutes. The site would be on the UC campus, which is close to the other three organizations. Somers said their agreement would create a nonprofit entity to plan and build the embryonic stem cell research facility. They would also pledge not to individually seek grants from CIRM.

Somers said, "A new building is important because federal limitations on stem cell research make it impossible to do much of the work in labs that receive federal funding."

Part of the consortium's strategy is to create a better chance of receiving grants, Somers wrote.

"'Individually all of the consortium institutes are stellar, but together we will be a tour de force and become the epicenter of stem cell research in the United States, and therefore the world,' said Dr. Edward Holmes, UCSD vice chancellor of health sciences."

Holmes, John Reed, president of Burnham, and Richard Murphy, president of Salk, are all on CIRM's 29-member Oversight Committee.

"In that role, they vote on who they think should receive research grants; however, the three would not be allowed to vote on grant requests from the consortium," Somers reported.

Zach Hall, president of CIRM, praised creation of the consortium, saying CIRM istrying to encourage the pooling of resources.

"Hall, a former vice chancellor at UC San Francisco, helped draft a plan for creating four distinct research institutes within the University of California.
"'They were all within the University of California and it was still difficult because each has different cultures, different personalities and different rules,' Hall said. 'The fact that these four institutions have put this together I think is a wonderful signal. I'm tremendously impressed with the effort that must have gone into this.'"

One of the players credited with pushing the effort during the last year is John Moores, who owns the San Diego Padres baseball team and is on the UC Board of Regents and the Scripps board. Reed said Moores was an important catalyst in pushing discussions forward.
------
For those of you outside of California, Jolla is pronounced hoy-yah. It is derived from the Spanish word "joya," which means jewel. There is a pun in there someplace about stem cell jewels and crowning consortiums, but we are not going to look for it.

Los Angeles Readers Told of Stem Cell 'Silliness'

LA Weekly, a 207,000-circulation alternative newspaper, has offered up its status report on the California stem cell agency in a piece headlined "The Stem Cell Debate Gets Silly."

Regular readers of this blog are not likely to find new information in the article by Steven Kotler. However, it does quote us on the subject of the stem cell trial, which obviously makes the piece worth checking out. It also quotes bioethicist Alta Charo as saying the stem cell debate is still "about everything but stem cells."

Kotler also wrote good-reading piece in 2003 on the state of stem cell research, which still retains freshness. A sample:

"Irv Weissman doesn’t look the bear-eating sort. He’s of middle height, middle weight, mildly balding, with fine clothes, a jovial aspect and a long, wispy beard. He looks like a Russian poet or an aged food critic. But, beneath this exterior, he’s just a boy from Montana. Which is to say he comes from a culture of bear eaters."

Kotler's website makes it difficult to provide a direct link to the story, but you can find it under "articles" Jan. 1, 2003.

CIRM Faces State Performance Audit

The California stem cell agency is facing a new and tougher official examination of its performance.

That is the result of approval of a request by Sen. Deborah Ortiz and 10 other legislators for a review of CIRM by the California auditor general. The audit should be significantly more rigorous than the ones authorized by state law involving the state controller's office.

Ortiz' office released the following statement:

"In presenting the audit request, Sen. Ortiz said the audit will review the administrative expenditures as well as the policies and procedures to ensure they are consistent with the intent of the initiative and with best practices for research organizations and public agencies – critical steps to ensure that up to $7 billion in public money is being spent appropriately.

"'I believe the audit will help ensure that the program is on sound footing as it moves into its grant-making phase next year,' she said.

"In her testimony, Sen. Ortiz noted CIRM and ICOC will have spent close to $8 million in administrative funds by the end of the year and approved $40 million in training grants in September 2005, which they hope to finance through loans from philanthropic organizations since the public bonds authorized by voters in approving Proposition 71 are held up by litigation.

"As some of you know, the program has stumbled in its first year of existence,' Ortiz said. 'It has struggled with implementation of open meeting procedures as well as policies to guard against conflicts of interest on the part of its working group members. In addition, it has issued contracts for some questionable things, including a $27,000 per month contract for public relations work, a $300,000 contract for private legal counsel and a $10,000 per month contract for lobbying.'

"State Auditor Elaine M. Howle said the audit would evaluate the CIRM’s and ICOC’s strategic plans, including determining whether they are clearly defined. Her office also will determine whether CIRM and ICOC are properly identifying and avoiding conflicts of interest, establishing realistic timetables realistic, have in place effective management controls to ensure they are complying with state laws and whether they are protecting the state’s interest. She said her office also would evaluate the development of policies and procedures, including contracting for facilities, hiring practices and the procurement of goods and services.

"Howle estimated the length of the audit will be six months. She did not say when the audit would begin."

The legislature's joint audit committee approved the audit today by a 9-0 vote. Reporter Steve Johnson of the San Jose Mercury News wrote a story on the decision. You can read it here.