Two Years Before the Stem Cell Mast

Two years ago this month, the California Stem Cell Report began its journey into the multibillion dollar world of embryonic stem cell research.

Since then, we have published more than 900 items on California's extraordinary and unique effort to pump up one of science's more controversial areas of research. Readers have paged through the website tens of thousands of times. They came from throughout the nation and the world, seeking more information about what the small band at CIRM is doing on King Street in San Francisco. (Editor's note: More recent and additional information can be found in an Sept. 17, 2007, article on Wired.com)

The reception has been generally favorable. "The ultimate source for all things California" is how Jim Fossett, director of health and Medicaid studies at the Rockefeller Institute, described the Report on the blog of the American Journal of Bioethics. "Comprehensive," "first thing I read in the morning," "enormously valuable" are some of the comments from other readers, whose numbers include law firms, newspapers and biotech companies. Studies of the California stem cell agency have cited the California Stem Cell Report (CSCR) as a source. University instructors use it as part of their curriculum.

Yahoo nows ranks the site No. 1 and Google No. 4 when using the search term "california stem cell." The rankings are up from near invisibility on the search engines when we began this endeavor in January 2005, less than a month after the first meeting of CIRM's Oversight Committee.

We started this website largely because we were interested in the subject and wanted to learn more. Given our professional background as a newspaper editor (now retired), former state Capitol reporter and gubernatorial press aide, we figured we might as well write about the subject and share the information with others.

It is not often that one can explore an area that stands on the cutting edge of science and medicine, that combines big business, academia, politics and government in a way never seen before in California, perhaps in the country. Not to mention the heated and sensitive religious, ethical and moral issues surrounding embryonic stem cell research, along with the hopes for cures for millions afflicted with diseases ranging from diabetes to cancer. CIRM is an agency – created directly by the people of the state, not the legislature or governor – that plans to give away $3 billion in public funds, basically unsupervised by the normal processes of state oversight. And its directors – voters decided – come from some of the universities and institutions that would benefit directly from its research and building grants.

We surmised that others would also be interested in CIRM but simply would not be able to find all they wanted to know, given the media's practice of covering only the most high profile news. That has proven to be the case. CIRM is virtually invisible to the public and much of the scientific and business community, if they rely on the mainstream media. It is even something of a low profile matter for the scientific media, and even lower in the business press.

Nonetheless the California Institute for Regenerative Medicine has become a benchmark worldwide and nationally for a number of issues including treatment of egg donors and intellectual property rights. CIRM has pioneered new and higher standards in both areas.

We have attended numerous CIRM meetings and visited CIRM headquarters several times. On one occasion, we covered the CIRM lawsuit trial live, filing items directly from our laptop in the courtroom in Hayward. Our reporting largely relies, however, on the Internet, sifting through government documents, news stories and email from a variety of contacts.

Since we travel regularly, gaining access to the Internet is always a challenge. We have used wireless connections in public libraries in San Mateo, San Diego and Santa Barbara and while at anchor on a sailboat in bays in Mexico. At other times, we filed via satellite uplinks, Internet cafes and hotel Web services and used a datacard for Mexican cellular service.

All of that would have been impossible 10 years ago, prior to today's advances in computer and Internet technology.

We hope the California Stem Cell Report has provided information that cannot be found elsewhere as well as serving as a guide and source of analysis and commentary on the Golden State's ambitious effort. We also hope that it has become something of a repository for the full text of California stem cell information that does not have a good home elsewhere, whether it is the statements of California stem cell chairman Robert Klein, acting in a non-governmental role, or documents from critics of the agency.

We are planning improvements and changes in the Report for 2007 and welcome suggestions from our readers. We are particularly interested in bringing in more voices from the stem cell community. Please let us know what you think. What do you want to see more of? What do you want to see less of? Do you have questions that need answers? You can send them and your suggestions to djensen@californiastemcellreport. Or you can post them directly on the blog by clicking on the word "comment" below. If you wish, Google, the hosting service for the blog, provides for anonymous "comment" postings, whose authorship is totally encrypted.

Stem Cells and 'Things that Go Bump in the Night'

What's going on with those CIRM scholars, those folks whose education is being assisted by the California stem cell agency?

Reporter Bradley J. Fikes of the North County Times in San Diego County wrote about 32 of them, including some from fields such as bioengineering, bioinformatics and chemistry. Among other things, Fikes said that ethical training occupies one-third of the curriculum in this particular program.

Fikes quoted Larry Goldstein, director of UC San Diego's stem cell program, as telling the scholars that they have an obligation to become missionaries – not Goldstein's word – for ESC research. Goldstein said:

"Some of you have been studying fish and flies and things that go bump in the night. It's not always obvious to the public how this relates to humans. For better or worse, the world is watching us, not just in San Diego, but in California."

Stem Cell Humbuggery and Its Implications for California

Citizens of California and the American public overwhelmingly support embryonic stem cell research? Balderdash!

California stem cell Chairman Robert Klein and a host of others cite public opinion polls to support their mission, denouncing critics as opposing the will of the people. That position, however, is a bit of humbuggery – dangerous if uncritically believed by supporters of ESC research.

We have argued that support for embryonic stem cell research is quite soft and that the science is poorly understood by the public. Now comes additional evidence for that contention, including an analysis from a devout supporter.

We will discuss the major implications for CIRM a bit later, but first let's consider the thorough-going discussion of the polling data by Matthew Nisbet, a scholar at American University who has studied the subject for some time. In a piece on the website of the Committee for Skeptical Inquiry, he wrote:

"...(O)verwhelming public support is by no means a 'slam dunk' conclusion. In fact the best available polling data shows that while support for research has increased since 2001, support among American adults lingers at only slight majority levels. "

Nisbet continued:

"We are now going on year six of the stem cell debate, and despite major news attention to the issue, and tens of millions of dollars spent on advertising and communication campaigns across the country, the public still scores relatively low in both knowledge of the science and the politics involved."

Nisbet discussed how the wording of the polling questions shapes their results. He also examined how supporters and opponents frame the stem cell issue. While Nisbet did not discuss in detail the 2004 election that created the California stem cell agency, it was a masterpiece of framing. Prop. 71 became a matter of aiding the sick, including members of each voter's family, and boosting the California economy – short-circuiting the feeble efforts of opponents, who largely relied on faith-based moral arguments.
But Nisbet added:

"In recent years, opponents have also evolved in their message strategy, realizing that they can potentially impact the ambivalent citizen on the issue by pairing the moral interpretation with a 'public accountability' frame that defines funding as only benefiting 'special interest' biotechnology companies. The emphasis on the 'commodification of life' by 'corporate science' may resonate with segments of the public that might otherwise reject religiously-based appeals."

Rachael Laser of The Third Way, a "progressive" pro-stem cell think tank, wrote about the public "ambivalence" on ESC research on the group's blog, in addition to preparing a 9-page paper on the subject (which cited this blog as one of its sources).

She wrote:

"The real story is that the majority of Americans are concerned that our fast-paced scientific progress brings with it significant moral hazards. If you are a Third Way groupie (and really, who isn’t?), you will not be surprised that we call the folks in the middle of this debate the 'stem cell grays.'

"By contrast, the 'stem cell polars' are on the extremes: some think that stem cell research raises absolutely no moral concerns; others beleive that it is so morally offensive that they would not support it even in if they knew it could cure a family member of a dreaded disease.

"But to the stem cell grays, America is sort of like the crazy scientist in the lab – he might well be a genius, but he also might blow his lab sky-hight. This concern is also borne out in a series of Virginia Commonwealth University polls that reveal that 56% of Americans believe that science does not pay enough attention to moral values, and 51% also believe that “scientific research has created as many problems for society as solutions.”

"Until stem cell advocates address these types of concerns head-on, they will continue to battle risky margins or Pyrrhic victories."

Nesbit reinforced Laser's point:

"Given the multitude of competing issues in the world, and given limited time, motivation, and ability, it is in fact quite reasonable for the public to rely on heuristics such as partisanship or religious belief to make up their minds about a complicated issue such as stem cell research. This fact might not fit with democratic ideals or with the preferences of scientists, but it is human nature.

"Political strategists understand this, and it’s why they carefully frame their messages around simplistic interpretations of either 'stem cell research leads to cures,' or 'stem cell research is morally wrong,' pairing these messages with celebrity or religious spokespeople. However, for science advocates who care about winning the short term political battle to overturn Bush’s misguided stem cell policy, there is a delicate balance to be struck. As I have argued elsewhere, narrowly focusing on educating the public about the science or the 'facts' involved in the debate will not move public opinion nor be persuasive.

"In the stem cell debate, science advocates need to make sure that they are honest about the uncertainties in research, while simultaneously communicating the hope for important therapies and treatments. As I have argued in this column, accuracy in communication also means being honest about where public opinion stands.

"The opposition is watching, and when inevitable scandals in science erupt such as the Korean cloning affair, stem cell opponents are going to shower communication channels with claims that scientists are willing to go to any extreme to promote their self-interests, and that embryonic stem cell research is 'junk science.' In our sound bite culture, and especially when research opponents don’t play by the same rules, effectively engaging the public on stem cell research is a major challenge. Yet wisdom and precision is needed. At risk is public trust."

What does all this mean for CIRM? The agency faces a greater burden in maintaining public trust than most other state agencies because of its built-in conflicts of interests and its extraordinary independence from normal state oversight. Consequently its procedures must be perceived to be transparent and blemish-free. Perception is the hallmark here. Otherwise the institute can be easily besmirched as a giveaway program for biotech. A substantial public education effort concerning ESC research is needed to generate deeper and more sophisticated support for the science and medicine. Outreach, outreach and more outreach are the watchwords. That includes a much improved website and establishment of CIRM as the key resource for national and state media to consult on ESC matters. And a regular, strong effort in the state Capitol is necessary to maintain a friendly or at least a neutral environment.

Stem Cell Stocks: Buying a Will-o'-The-Wisp?

To slightly paraphrase one analyst, anybody buying stem cell stocks solely based on the House vote on ESC research should be prepared for a long, hard ride.

In the wake of the Congressional action, Aaron Smith of CNN prepared a more nuanced report on stem cell stocks than we saw in news reports last week.

Smith wrote:

"In anticipation of today's vote, investor interest in biotech stocks has been whipped up, though biotechs probably wouldn't benefit directly from the funding, even if it's eventually approved.

"'This is a step in the right direction, but if anyone is buying StemCells Inc. based on this one vote, they need to rethink their priorities,' said Steve Brozak, analyst at the investment and research firm WBB, referring to one of the biotechs involved in stem cell research."

The CNN report continued:

"Although StemCells Inc. (down $0.08 to $3.35) stock fell about 2 percent Thursday, the stock's climbed more than 25 percent so far this year. It's the most recognizable name in the industry, analysts say, even though it doesn't stand to benefit directly from the vote.

"'The stock [StemCells] is probably most tied to political movement, just because of the ticker," said Jose Haresco, analyst for Merriman Curhan Ford & Co., an investment research firm, referring to the company's stock symbol of STEM. "It's almost a perfect barometer."

"The stock of Aastrom Biosciences (down $0.08 to $1.46) slumped about 5 percent Thursday, but overall gained about 20 percent this year. Haresco said that StemCells and Aastrom specialize in the use of adult stem cells however, not the ones derived from human embryos, which are the subject of the bill.

"The stock price for Osiris Therapeutics (down $1.37 to $26.77, another biotech specializing in adult stem cells, also gained this year, though it slumped about 5 percent in Thursday trading.

Geron Corp., (up $0.20 to $8.90) a biotech developing stem cell technology which is based on human embryos, has been volatile this year and only pulled into the plus column Thursday, when the stock rallied about 2 percent. The stocks, save for Geron, had run up after news of the possible House vote first surfaced last week.

"'Geron is clearly at the top of the pack," said Brozak of WBB, who rates the company a "strong buy," noting that it is the most advanced in the development of embryonic stem cell technology.

"Geron's most recent stem cell study involved rats, not people, though a spokesman for the company said early-stage human trials will begin in 2007."

Fuel Your Stem Cell Edifice Complex

Looking for some bucks to renovate your aging stem cell lab?

The California stem cell agency is seeking a few good institutions to share $48.5 million that could start filling their coffers by this summer.

Those of you outside of California are out of luck unless you can concoct a California presence very quickly. CIRM announced today that it wants letters of intent for shared facilities grants by Feb. 2.

The agency's press release said:

"The grants will provide funds for the design and renovation of laboratory space, equipment for the new research facilities, and operating expenses for three years. Some grants will include additional funds to train scientists and technical staff in the growth and maintenance of hESCs."

CIRM continued:

"'The ICOC funded grants to train 169 stem cell scientists last year and will award more than $100 million in research grants this February and March,' said Richard Keller, the Institute’s Senior Officer for Scientific and Medical Research Facilities. 'Shared Research Laboratory Grants will ensure that scientists have the physical facilities they need to cultivate new lines of embryonic stem cells, without running afoul of federal restrictions and without endangering federal funding for other research activities.'

"CIRM expects applicant institutions to provide at least a 20 percent match of the total cost for renovation and equipment. They may request up to $2 million for laboratory space development and an additional $500,000 if they plan to offer a stem cell techniques training course. The RFA is open to all academic and non-profit research institutions in California.

"The Request for Applications (RFA) for shared facilities grants is available at http://www.cirm.ca.gov/rfa/pdf/RFASharedResearchLaboratoriesfinal.pdf. Potential applicants must submit letters of intent to CIRM by February 2, 2007. Full applications will be submitted in two parts. The first part will describe the scientific mission of the proposed facility and is due February 23rd; the second part will detail renovation and/or development of the laboratory space (including fixed equipment costs), and is due on March 16th."

The Riddle of the Stem Cell Trinity

Can science, business and government work together in a win-win combination in a unique endeavor involving arguably the most controversial research in the world and billions of dollars in funding?

That is the key question ultimately for the California stem cell agency. Now we have some help in seeking answers to at least two-thirds of the riddle.

The aid comes from an analysis by Harvard business professor Gary Pisano in his new book: "Science Business: The Promise the Reality and the Future of Biotech." Pisano examines the sometimes difficult mix of business and science and their conflicting cultures. He omits the hefty government component represented by an agency such as CIRM, which has deeper hooks into science and business than the NIH.

Pisano, who has a Ph.D. from UC Berkeley, has studied the biotech business for years and has served as a consultant to some biotech companies.

We ran across his book as the result of a review in the Wall Street Journal by Andy Kessler, author of "The End of Medicine." Kessler wrote:

"Can science and business mix? ...The problem, according to the Harvard Business School professor, is that today's corporate structures are allergic to the uncertainty and risk inherent in science."

Kessler noted:

"Cumulative profits for the entire biotech industry are meager. The whole lot of them probably drip red ink if you take out Amgen, a 26-year-old company with $14 billion in annual sales and -- like Genentech and just a handful of others -- real profits."

Kessler continued:

"Mr. Pisano notes that 'drug R&D is a highly complex process; it is expensive, time consuming, and fraught with risk. In these respects, drug R&D is not too different from, say, the development of a new airliner, a new microprocessor, or even an epic movie.' The key word is risk. While an Airbus plane, Intel's Core Duo or 'Apocalypto' may have market risk, their development is undertaken with confidence that the products will at least make it to market; drug companies begin work on a new product with no idea whether it will even make it out of the lab, much less progress through clinical trials and onto drugstore shelves. A new drug might have the potential to be a blockbuster, but, then again, only one drug out of 6,000 newly developed compounds actually goes on sale. 'Productivity' is not a word used often in the drug business.

"'Drug development is a gamble in itself simply because of the hit-or-miss nature of the science -- or the 'profound and persistent uncertainty,' as Mr. Pisano calls it, 'rooted in our current limited knowledge of human biological systems.' But it becomes a staggeringly expensive gamble -- like playing blackjack at a table with a billion-dollar minimum -- because of the facilities required and the legions of experts in chemistry, biology, genomics and other fields who pour their time and energy into research. The 'nature of this process is integral,' Mr. Pisano points out. 'It cannot be broken neatly into different pieces.'"

Kessler's review prompted us to purchase the book, which appears to be very much worth reading. You can find a lengthy excerpt here or purchase it by clicking on one of the Amazon ads at the top of this blog.

Beware the White Coat Crowd

Health industry gadfly Merrill Goozner is taking a jaundiced view of the stem cell arms race in states across the country.

Citing New York's latest proposal and California among other states, Goozner wrote on The Huffington Post:

"Stem cell research is promising, and it shouldn't be impeded by a bunch of anti-science right-to-lifers with God and the president on their side. But like any strain of research, the likelihood of a major medical breakthrough coming from stem cells is probably not that much greater than gene therapy, the human genome project, the war on cancer or any of the multi-billion-dollar medical research programs that came before it. A lot of knowledge and a few good things will come out of stem cell research, but will it make those with severed spines stand up and walk? Call me irreligious, but I'm skeptical."

He continued:

"Of course, there will be some new jobs created for university researchers, their underpaid foreign graduate students, and the white coat crowd in the biotech industrial parks subsidized by the taxpayers. But is this really the best use of government subsidies, especially at a time when the health care sector -- 16 percent of GDP and still growing -- is sapping the vitality of the rest of the economy? Has anyone given any thought to how much some of these breakthrough stem cell technologies might cost, and how the rest of the economy might pay for them?"

Goozner is directs the Integrity in Science Project at the Washington-based Center for Science in the Public Interest.

CIRM and Its Embarrassing Secrecy

The California stem cell agency rather foolishly conceals the identity of applicants for its multibillion dollar grant program, contending that unsuccessful scientists and their employers would be embarrassed if the public were to know that they failed to receive funds.

We say foolish because CIRM's rules are a nonsensical exercise as well as poor policy(see the "more disclosure" item below). The institutions themselves are free to release the information that they have applied, and they do. The most recent example is USC. Last fall, UC Irvine did so.

One can only speculate about why the schools release the information, although the process of applying for grants in other areas is often very much a public process. Some cynics have surmised that the release of the information by the schools could be an attempt to serve notice on CIRM and its Oversight Committee that these mighty institutions should not be overlooked when the checks are handed out. Both USC and UC Irvine have representatives on the Oversight Committee, which makes the final decision on who shares in the largess, although those committee members are barred from voting on their own school's grant applications. Of course, more benign reasons exist for universities to tell the public they are seeking grants. But CIRM's secrecy only fuels the fire of conspiracy theories.

USC's item said the school submitted 29 applications for the round of applications reviewed last fall and for the round being reviewed this week.

"'The competition for this funding will be tough, but USC scientists have put together some very exciting proposals,'" said Martin Pera, director of USC's Center for Stem Cell and Regenerative Medicine (CSCRM) and a professor of cell and neurobiology."

The item continued:

"Pera said that researchers from CSCRM and its Stem Cell Core Laboratory 'were pleased to lend our expertise in support of these grant efforts in this first round of CIRM grants.'

"The exercise 'brought together many groups throughout USC, Childrens Hospital Los Angeles and the California Institute of Technology for the first time,' he added. 'As a consequence, a number of new interdisciplinary collaborations have emerged with the potential to develop into world class research programs in stem cell biology and therapeutics.'"

Given the dearth of ESC research funding, any California institution making an effort in the area can be expected to seek grants. Likewise, institutions with stem cell aspirations. But their names and the names of the scientists as well as the general nature of the application should be part of the public record.

Why CIRM persists in concealing the identities of applicants is hard to understand. If it truly wanted to maintain secrecy, it could disqualify an institution whose application became public knowledge, for whatever reason. Then nobody would be embarrassed.

CIRM's Lansing to Receive Oscar

Former Hollywood film executive Sherry Lansing will receive an Oscar this year for, among other things, her role at the California stem cell agency.

Lansing sits on the Oversight Committee of the California Institute for Regenerative Medicine, a position she has held since the agency's inception.

Last summer, she was cited specifically by California stem cell Chairman Robert Klein for making a "critical call" to Arnold Schwarzenegger to nail down the $150 million loan to CIRM that is allowing it pump out the cash this year.

Lansing is engaged in several other endeavors that were cited in the announcement that she will receive the Jean Hersholt Humanitarian Award at the Academy Awards in February. She serves on the board of Stop Cancer and the American Red Cross' Advisory Committee. She is also a regent of the University of California and a trustee of the Carter Center human-rights organization

Comments Sought by Your Mexico Correspondent

Mazatlan is nicely warm this time of year, much more pleasant than cold, cold California was during the holidays. And that's where the California Stem Cell Report is currently moored – Mazatlan, the Pearl of the Pacific.

We have stripped off our jackets and shoes, replacing them with shorts and sandals.

We are ensconced in Marina Mazatlan, which has clean showers and wireless Internet access from the boat. However, like stem cell research, the full potential of the wireless access is yet to be realized.

The link to the Internet has been sporadic. As best as we can determine, the DSL line provided by TelMex, one of the most egregious monopolies in Mexico, needs some sort of new electronic card. It has been ordered from Hermosillo, we are told. When reliable service will return is yet to be determined.

Meantime, we will schlep our hefty laptop in its hefty black Pelican case to the nearest Internet cafe (access cost 90 cents or so American an hour) via bus (40 to 80 cents American one-way). In Mexico, buses are often more convenient and faster than taxis. Both can be quite exciting. Oddly, the bus costs more than a three-mile bus ride in Santa Monica to the CIRM meeting at UCLA last October. That was only 25 cents, an extraordinarily low fare.

We also are working on improvements and changes in this website. Please let us know if there are features or information that you would like to see added. And please let us know about matters that you are not fond of. Send your comments directly to djensen@californiastemcellreport.blogspot.com and or just post them as a comment on this item. You can post your comment – anonymously if so desired – by clicking on the word "comment" below.

More Disclosure in Billion Dollar Giveaway Is In CIRM's Best Interest

California's $3 billion stem cell giveaway program began another important step today – one that is cloaked in nearly total secrecy despite the fact that it involves public funds.

Scientists in San Francisco are reviewing applications for $80 million in major grants. CIRM says their actions are only recommendations. However, the reality is that they are defacto decisions that are unlikely to be overturned by the agency's Oversight Committee.

A certain amount of confidentiality is to be expected, but the agency has gone overboard to protect the tender sensitivities of those seek the funds. It is a practice that will serve the agency poorly should questions arise – as they are certain to do over the next decade – about the propriety of its grant-making process.

We have written repeatedly about failings in transparency and disclosure at the agency. It is also a topic of concern to a number of newspapers and watchdog groups. John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumer Rights in Santa Monica, Ca., authored an op-ed piece that appeared today in the Oakland Tribune and other California newspapers.

He wrote:

"Everyone concerned claims they want a transparent process to ensure that awards are based on scientific merit, not favoritism and cronyism. Despite mouthing high-minded slogans, the institute's leaders too frequently miss the mark whenever there is a clear opportunity to build faith in its processes by being completely open.

"In California we don't know who applied for the grants or their affiliations. Our stem cell institute need only look to Connecticut where applicants' names and pertinent details are public record for a model of how to conduct the public's business.

"Fortunately at least one California scientist understands the importance of a completely transparent process when dealing with public funds. Connecticut's stem cell peer review committee — the equivalent of California's grants working group — is chaired by Dr. Leslie P. Weiner, professor of neurology at the University of Southern California's Keck School of Medicine.

"The California stem cell institute won't identify the 70 researchers from 23 unidentified institutions vying for 25 grants under the Comprehensive Research Grants program.

"In my personal life, I don't give money to people unless I know who they are, why they want it and what they plan to do with it. It shouldn't be any different with the taxpayers' $3 billion. Another opportunity for transparency and to build public faith in the institute's procedures is being squandered."

So wrote Mr. Simpson, who has followed CIRM's activities for more than a year and is a supporter of ESC research.

As for us at the California Stem Cell Report, if we were one of the scientists making decisions on the grants, we would want to have the maximum amount of openness, including disclosure of the financial interests of our fellow reviewers. Without transparency, it is all too easy for enemies of embryonic stem cell research to impugn the integrity of reviewers and to insuinate – as they most certainly will do -- that something other than good science is playing a role in handing out hundreds of millions of dollars in California taxpayer funds.

Embryonic stem cell research generates more than enough controversy. It is past time for the California stem cell agency to take steps to protect itself and its grant reviewers -- all of whom come the tiny circle of stem cell scientists around the world -- from the inevitable charges of self-dealing, cronyism and favoritism.

The California Poster Child, Stem Cell Wars and Proverbial Church Picnics

Are states running amok with embryonic stem cell research? Should or can the federal government reassert its control? Can workable compromises be found?

Richard Hayes, executive director of the Center for Genetics and Society in Oakland, Ca., addresses these issues in a piece on Bioethics Forum, which is sponsored by the Hastings Center Report.

Hayes writes about the "sorry" state of the stem cell debate:

"This polarized politics has given us the worst of all possible worlds: a policy stalemate at the federal level accompanied by a plethora of state-level stem cell funding programs lacking the sort of planning, ethical oversight, and regulation that biomedical research of such consequence requires. California's $3 billion stem cell program is the poster child of this predicament. Since its inception in 2004 it has been under fire for conflicts of interest, inadequate concern for the health and safety of women who provide eggs for stem cell research, unrepresentative policy-making bodies, and misplaced research priorities.

"These flawed state programs are setting the stage for even greater problems to come. Technologies now under development, including pre-implantation genetic diagnosis for both medical conditions and cosmetic traits, somatic genetic enhancement, and inheritable genetic modification, promise to make the stem cell wars look like the proverbial church picnic.

"If these technologies are embraced by the largely unaccountable infrastructure now being established to support stem cell research, they will be difficult to constrain. Once developed and made commercially available, they would be used disproportionately by the most privileged, and become new and powerful drivers of inequality and exclusion.

"The tragedy of this situation is that public opinion surveys consistently show that a strong majority of Americans support a morally serious middle ground regarding the new human genetic technologies. Americans are not irrevocably opposed to research involving the destruction of human embryos, but they want to make sure it is done only after alternatives have been exhausted, and with effective structures of public oversight in place. Americans want cures for diseases, but few are willing to turn the genetic future of the human species over to dismissively arrogant scientists and profit-hungry biotech boosters. Unfortunately, no organized constituencies with influence comparable to that of the religious conservatives or the research/patient/bioindustrial community exist to represent this majoritarian position in the political arena."

Hayes finds some hope in the approach detailed in "Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies," by Francis Fukuyama and Franco Furger. Hayes said the book "could serve as a rallying point for those desiring an end to the current counterproductive policy stalemate."

Hayes called the book "the most comprehensive analysis of human biotech regulatory policy yet published in the United States. With the 2008 congressional and presidential campaigns now moving into high gear, the report comes at an opportune time. "Beyond Bioethics" should be studied carefully by everyone interested in working towards human biotech policies that can be supported by the great majority of Americans."

Gov. Arnie on Stem Cell Research

Former thespian Arnold Schwarzenegger was inaugurated today as governor of California. He had an enthusiastic but overstated line in his inaugural address about stem cell research. Here it is:

"Because we were leaders in stem cell research, California’s bio-tech industry has boomed, offering new cures for spinal cord injuries, Alzheimer’s, Parkinson’s and other diseases."

His speech is available live today beginning at 11 a.m. PST. (7 p.m. Greenwich Mean Time)

Stem Cell Market Fever: A Cooler Perspective

Are stem cell stocks really rising because of Democratic control of the House of Representatives? Probably not.

Are markets truly rational? Are stock analysts always well-informed? Probably not.

The questions come up because of a few articles concerning the sharp run-up in the price of some stem cell companies, including those based in California, in the last two days. The Associated Press (in the San Jose Mercury News and elsewhere) attributed the increase to the improved prospects of House passage of a measure aimed at encouraging federal embryonic stem cell research.

These daily trading stories are usually ripped off by relatively inexperienced reporters who grab the quickest and catchiest explanations for price rises. Some of those come from analysts who may not be well-informed and who do not understand that a presidential veto is likely again on the stem cell bill – a veto that probably will not be overridden. Even if it is, the National Institutes of Health are already hard-pressed financially and are not likely to come up with major increases in ESC reasearch funding, certainly nothing on the level of California's $3 billion giveaway. Beyond that, the markets have already factored in Democratic control of Congress, which is months-old news.

A more likely cause of the upsurge in stem cell stocks is the wave that boosted biotech stocks generally because of good news about Amgen, among other things. Here is what the Wall Street Journal had to say this morning:

"Amgen, (Nasdaq) the second-largest U.S. biotech company by market value, behind Genentech, gained 2.93, or 4.3%, to 71.33. Bear Stearns upgraded Amgen's shares to 'outperform,' saying the stock already reflects potential impacts from Roche's prospective introduction of a competitive anemia drug. If Roche's drug doesn't reach the market, the upside for Amgen's stock could be 'dramatic,' Bear Stearns said."

Stem cell stocks are thinly traded but may be carried along in a burst of buying in the biotech sector. Traders sometimes spread their bets across a sector.

Also not mentioned in the stories is the impact of automated trading programs that trigger purchases as an entire sector moves, in other words, a computerized bandwagon, which may or may not be rational depending on your point of view.

Stem Cell Argonauts To Convene in San Francisco

Since all of you out there are looking at your schedule for the coming spring, be sure to reserve a spot for The Stem Cell Meeting in San Francisco.

Produced by Burrill & Company, the two-day session promises a host of provocative discussions and a broad range of international speakers. Topics range from “Stem Cell Argonauts: Brain Circulation in a Global Economy” to
“The Un-United States: Cell Lines, Border Lines, and the Law.”

According to the preliminary agenda for the March 12-13 event, the keynote speaker will be Ian "Dolly" Wilmut of the University of Edinburgh, whose topic is “Continental Drift: Where Will Stem Cells Take Us?”

So far no speakers from CIRM are on the agenda, but are likely to be there. No speakers from WARF are listed at this point. Beth Donley, then WARF general counsel, served notice at last year's session that CIRM would have to pony up fees to Wisconsin for use of WARF ESC patents.

We caught two days of last year's session. Hundreds of others attended. It was definitely worth taking in.

Early reservations (before Jan. 26) mean a $500 cut in the $1495 registration fee. The conference also offers an academic, government and nonprofit rate of $495. If you want to get more bang for your buck, double up with the CIRM Oversight Committee meeting on March 15 and 16 in Los Angeles. That session is free.

Correction

The item below once carried a reference to an article on biotech investing from the New York Times. The article was actually from 2005 not 2006. We have removed the reference.

Stem Cell Snippets: Advocacy, Public Support and Weissman

ESC Gospel – What is going on with Robert Klein's Americans for Stem Cell Therapies and Cures? One current activity is recruitment of more missionaries to spread the ESC gospel. The group has about 150 speakers across the country. It is looking for 1,000. You can read more about the effort on stemcellbattles.com, the blog of stem cell advocate Don Reed. Klein, as most of you recall, is also chairman of the California stem cell agency in addition to presiding over the lobbying group.

Stem Cell Investing – The tough business of biotech investing was discussed in a piece by Andy Pollack of the New York Times. An excerpt: "The difficulty of taking companies public, especially at values they find attractive, has become a lament of biotech venture capitalists, and it is forcing changes in their strategies. Instead of a way to cash out, the initial offering is now a chance to keep a company going until, hopefully, the venture investors can sell their stock later."

Squishy Public Support -- Jesse Reynolds of the Center for Genetics and Society discusses the nature of public support for ESC research and the most recent public opinion polls. Supporters of ESC research find constant hope in the polls. On the basis of decades of watching polls on politics as well as other subjects, the California Stem Cell Report believes that embryonic stem cell research is poorly understood by most Americans and is still a new subject to most persons. That means potentially mercurial support that can be easily undermined by changing events or skillful marketing.

Weissman – Stem "cellist" Irv Weissman speaks on "What Stem Cells Mean to Science, Medicine and California" Jan. 9 at a meeting of Silicom (cq) Ventures in Mountain View. Weissman is director of the Institute for Cancer and Stem Cell Biology at Stanford and helped found three stem cell companies (Cellerant, SyStemix and Stem Cells, Inc.). Tickets are $150 for nonmembers of the venture capital group.

Holiday Hiatus

The Christmas elves carried off your humble correspondent. But take heart. Postings will resume shortly.

San Jose Merc: 'It's Working.'

The California stem cell agency is continuing to bask in the light of several recent pieces in the mainstream media that portray CIRM in a generally favorable light.

The most recent came as an editorial today in the San Jose Mercury News, which said:

"Two years into the great California stem-cell adventure, here's everything curious taxpayers need to know about their $3 billion investment:

"It's working.

"Prominent researchers continue to flock to California. Confidence in the endeavor is so high that grants and gifts from private sources to California researchers have totaled more than $200 million so far. The feeble lawsuit challenging the program's legality should be history before June. And regulations are in place to govern the state agency in charge of distributing the $3 billion in grants, the first of which should be awarded in a matter of weeks.

"Given the nature of scientific research, it will take well over a decade to fully evaluate the state's stem-cell experiment. But it's already clear that, thanks to California voters, the United States is poised to become a world leader in one of the most promising areas of medical research today. That was not the case before Proposition 71 was passed in November 2004."

One CIRM staffer, who pointed with some pride to the editorial, noted that the agency's situation is a far cry from last year at this time. And he is right.

But the editorial also noted that the agency should revisit its "policy on transparency to shore up public trust. At a minimum, members of its working groups evaluating grant applications should be required to publicly disclose any conflicts of interests."

The Private Touch in ESC Research

The Washington Post today caught up with some of the doings at the California stem cell agency, reporting that private, "almost unprecedented contributions" have saved the day at CIRM.

The story by Sonya Geis said the loans have also helped fuel other giving for embryonic stem cell research in California, echoing a point made in the San Diego Union-Tribune series, "The Stem Cell Wars."

"Private money is also building new stem cell labs on university campuses across the state. Los Angeles philanthropist Eli Broad gave $25 million to the University of Southern California for a stem cell institute, sound-technology pioneer Ray Dolby gave $16 million to the University of California at San Francisco, and local donors are contributing to a $75 million expansion at the University of California at Davis.

"'I was amazed by the number of wealthy Californians who have stepped up and decided to support a public agency,' said Owen Witte, director of the new Institute for Stem Cell Biology and Medicine at the University of California at Los Angeles. 'I've never heard of anything like this.'"

Geis erred on one point, however. She said "affluent Californians gave $31 million" to CIRM. The money was actually loaned to the agency and is to be repaid with interest. However, if CIRM loses the lawsuit against it, the lenders will not be repaid.

The Stem Cell Race: How California is Like the Cobbler's Children...Sort Of

California's stem cell effort, still yet to dispense a single research dollar, has served as lever globally to boost funding for the field in locations ranging from New Jersey to Australia.

That's one of the conclusions of the third article in a three-part series in the San Diego Union-Tribune called "The Stem Cell Race."

Written by reporter Terri Somers, the piece examines California's $3 billion effort, which has been hampered by a legal tussle over its legitimacy. Somers wrote:

"While San Diego's large stem cell research community has been waiting to tap the state funding, the Harvard University area – supported largely by philanthropists – has become the U.S. science cluster best known internationally for embryonic stem cell research.

"Also pushing ahead have been the governments of Singapore, China, Japan and several European nations, which have supported their embryonic stem cell scientists with money and favorable policies.

"'Proposition 71 is supposed to help the economy by creating jobs first, then new tools and treatments, but until it really gets moving it's just an old Jag in the garage," said Tom Okarma, chief executive of Geron, a Menlo Park stem cell research company."

Somers continued:

"New York Gov.-elect Eliot Spitzer plans to push a $1 billion 10-year stem cell initiative that mirror's California's. On Friday, New Jersey's legislature approved borrowing $270 million to fund stem cell research. And Connecticut has floated a $100 million 10-year initiative. Part of the states' impetus was the fear of losing top researchers to California and abroad."

The San Diego article also reported:

"Scientists and government officials from 15 nations have visited the stem cell institute over the past year, said Zach Hall, the institute's president. Delegations from India, Israel, the United Kingdom and China were eager to forge relationships and take home ideas and the possibility of collaborations."

Nonetheless, Somers reported that 30 "notable" scientists have come to California in the last two years because of the state effort. An informational graphic with the story showed that private and federal funds totalling $234 million have poured into the state, boosting research efforts. And she noted that CIRM now has $181 million in hand, ready to dispense on research.

"'With these loans California's funding is now six times the nation's funding through the (National Institutes of Health) and California is squarely in the global leadership of this breakthrough field of medical research,' said Robert Klein, chairman of the California Institute for Regenerative Medicine."

Correction

A Nov. 21 item, "Nearly Awash," contained incorrect figures on some of the individual purchases of CIRM bond anticipation notes. Those figures have been corrected in that item. CIRM has also corrected the figures on its website.

The Stem Cell Race: Singapore's $370 Million Biopolis

In Singapore, embryonic stem cell research is spelled Biopolis. It is a simple way of saying, We focus intensely on people and laboratories, fast action and strong collaboration.

On Monday, reporter Terri Somers of the San Diego Union-Tribune examined Singapore's embryonic stem cell effort in the second of her three-part series, "The Stem Cell Race."

Here is how Somers described the life of one scientist at Biopolis:

"When she needs a new supply of embryonic stem cells, she phones in an order and walks across the campus of the science center her government has built to pick them up. Although her work is highly regulated, authorities have made obtaining human embryonic stem cells only slightly more difficult than snagging a box of pens from a supply cabinet."

Life seems good in the $370-million, 2.4 million-square-foot biotech research hub. Somers wrote:

"On what used to be grassland, a seven-building cluster of modern, glass-walled structures sprouted in 18 months. Enclosed glass walkways shelter workers from the unrelenting heat and downpours of the tropics, giving the complex the look of giant Habitrail for humans.

"Two more buildings opened in November, creating more space for the nine research institutes and consortiums that fill Biopolis, along with several research and development outposts of biotechnology and pharmaceutical companies.

"There's a storage facility for tens of thousands of mice for use in experiments, a tissue bank and a bioprocessing facility that is making the culture medium in which stem cells will be grown. Eventually it will produce millions of stem cells.

"The government accommodates the workers' long hours with a child-care center, supermarket, hair salon, dry cleaners, bars and even a 7-Eleven convenience store.

"On a typical workday, members of this multinational scientific community can be seen outside enjoying the cooling mist of a fountain, the shade of lush foliage or the convenience of a cafe, as they share ideas over lunch or lattes. They seem oblivious to the Miami-in-August temperatures and humidity."

The Singapore effort has paid off by attracting a host of first-rate scientists as well. Somers reviews the cast that now stars in the Biopolis "theater," ranging from UC San Diego's former medical school dean, Edward Holmes, and his wife, Judith Swain, a cellular cardiologist, to Neal Copeland and Nancy Jenkins, top ESC researchers from the NIH.

Somers' article also indirectly emphasized how tiny and interconnected the ESC research world is. For example, Singapore's efforts are hooked into the California stem cell agency. Somers reported,

"The advisory board to Singapore's Biomedical Research Council reads like a who's who of medical research, including David Baltimore of Caltech and La Jolla-based scientists John Reed of the Burnham Institute for Medical Research, Sydney Brenner of the Salk Institute for Biological Studies and Richard Lerner of The Scripps Research Institute."

Both Reed and Baltimore also serve as directors of CIRM.

Somers' second piece on Tuesday also reinforced the "small world" portrait of ESC research. She profiled Philip Yeo, chairman of the Agency for Science, Technology and Research, or A*Star, the long title of the man who is the mastermind of Biopolis. Somers wrote:

"Yeo called his friend Stuart Weissman, a pioneer in embryonic stem cell research at Stanford, seeking advice on what type of work could be done at Biopolis that would complement efforts in the United States.

"Yeo (then) set about trying to lure – he would say borrow – top researchers to Singapore. Governments jilted by researchers who have found his offers too good to refuse refer to him as a 'serial kidnapper.'"

On Tuesday, Somers will examine California's $3 billion stem cell research effort.

The Stem Cell Race: Underdogs, Singapore's Biopolis, China and the UK

The San Diego Union-Tribune Sunday began a three-part series on embryonic stem cell research globally, reporting that the United States is "getting a taste of being the underdog."

Reporter Terri Somers, who has followed the industry and the California stem cell agency from San Diego's biotech hotbed, also wrote a Sunday piece looking that the business side of the research.

Both Sunday articles are as comprehensive on their subjects as one is likely to see in the mainstream media. Included is a downloadable world map with country-by-country snapshots.

Here are some excerpts from the front page series called "The Stem Cell Race:"

"'For the first time, we have a lot of competition ... . I don't think we've had as much concern for another country besting us in science since the race to the moon,' said Dr. Evan Snyder, who runs the embryonic stem cell research program at the Burnham Institute in La Jolla.

"It is a competition with crucial consequences for San Diego County and California, home to leading stem cell researchers and 50 percent of the world's biotechnology research."

Somers continued:

"China reportedly is doubling its investment in stem cell research. But an air of mystery and skepticism surrounds China's work, because the country's regulatory guidelines differ from those in the West and because research from Chinese scientists has not been widely published.

"The United Kingdom already has invested about $198 million in stem cell research at 90 laboratories, of which 11 are licensed to conduct human embryonic stem cell research.

"Singapore, with just 4 million citizens, is investing $25 million to $29 million annually in research, excluding overhead costs and infrastructure.

"That investment may seem wimpy compared with the $609 million the United States government spent on stem cell research last year. But because of federal funding restrictions on human embryonic stem cell research, only $20 million to $40 million a year – about 6 percent at best – has been directed to that field.

"Money is not the sole catalyst of success. Scientists say supportive government policies that free them to concentrate on their work, national commitment and contagious scientific enthusiasm are just as important.

"'Here we are again, sitting on the beginning of another revolution, a possible way to provide cures rather than treatments," said Chris Mason, a stem cell researcher at University College London. 'The U.K., Singapore and other countries realize what might be within their grasp if they spend the money on the front end, and they don't want to miss it.'

"The United States, long the world leader in biomedical research and commercialization, is getting a taste of being the underdog."

Somers' piece on the business of stem cells said:

"Worldwide, only about a dozen companies are building a business based on human embryonic stem cells, and only three of those are publicly traded: Geron in Menlo Park, Advanced Cell Technology in Alameda and Stem Cell Sciences in Edinburgh, Scotland.

"Executives at several of the companies say the key to tapping funds at such an early stage is either finding someone with deep pockets and a personal passion for curing disease or possessing a unique technology to address a potentially huge market.

"Given the current business climate and the political and moral debate surrounding human embryonic stem cells in the United States, people in the business don't expect more competition to pop up soon."

On Monday, Somers will look at Singapore and its "Biopolis."

'Fair Cures,' Lab Construction and CIRM

The Greenlining Institute, a longtime activist community group in California, has come up with a series of recommendations on stem cell research in California, including suggestions that biotech companies receiving state grants set goals for directing some of the money to minority and women-owned businesses.

The proposals stem from a Greenlining conference earlier this year on stem cell issues. They have been compiled in a report, called "Fair Cures," prepared by Joe Araya Tayag, health program manager for Greenlining. The group has been around for decades and has litigated and agitated successfully on a wide range of issues involving minorities. The organization's name stems from its position opposed to the practice of redlining.

Currently CIRM is preparing a proposal to fund $47.5 million million in lab facilities. The grants are expected to be awarded in June. The agency has generally indicated support for diversity efforts, but it is not clear how that might be reflected in its grants for labs.

Here are excerpts from Greenlining report. It can be found on the website from the conference, which includes video of the presentations:

"...(R)esearchers and firms that obtain patents on health care technology, such as stem cell advancements, have virtually no incentive or authorization to ensure fair access to innovations in medical treatment. Without an adjustment in patent law, the cost of patent licenses in the stem cell industry will impact costs of any potential products. Because researchers have to recoup the costs of licenses, prices are driven up, with the greatest burden ultimately falling on disadvantaged communities of color. The CIRM currently includes provisions for affordability in their intellectual property policies that may be used as models for future state-funded research programs."

"Conference participants also voiced their concerns over how the tens of thousands of employment opportunities to be created with the state’s investment into stem cell research will be distributed fairly among all Californians. These jobs take the form of research positions, CIRM career staff, and supplier contracts. In his presentation, Joe Tayag from the Greenlining Institute showed that there were over 60 different types of supplier services used by a large biotech company. These jobs range from advertising, to catering, to furniture manufacturing. Audience members such as Ernie Baker from the Covenant on Health in San Francisco stressed that these jobs may empower economically underserved communities if employment rates reflect the diversity of the state. Conference participants agreed that these jobs need to be recognized as essential to stem cell research and should be accounted for in any discussion of the fair implementation of stem cell research."

CIRM Scholar Produces Mouse Brain Finding

There it was – in the 4th paragraph of the press release – a CIRM scholar produces a newsworthy finding as the result of "some of the first research funded by the California stem cell agency," according to one reporter.

Rebecca Vesely of the Contra Costa Times highlighted the CIRM connection in her story about the research at UC San Francisco that suggests "stem cells in the brain have a surprising capacity to repair damaged tissue." She said that researchers indicated that "the findings could help in the quest for treatments of brain trauma such as stroke."

Chay Kuo, a postdoctoral fellow at UCSF, led the study. The press release from UC San Francisco said:

"Kuo is one of 16 UCSF CIRM Stem Cell Scholars – up and coming young scientists funded by the California Institute for Regeneration (sic) Medicine, established by California voters in 2004 to allocate $3 billion over 10 years to support stem cell research."

Vesely noted that funding also came from the National Institutes of Health. She also wrote:

"Kuo said he received a $45,000 stipend, plus funds for medical benefits and a $10,000 allowance for research costs.

"'It allows trainees independence,' he said. 'It's given me incredible freedom to do my research.'"

Obviously the research is of considerable interest, but what adds to it is the CIRM-funding connection. One of the abiding concerns at the agency is producing results that fulfill the promise of Prop. 71. This is the first such event the agency can point to, albeit only as a modest funding effort.

Kuo's research, to be published in Cell magazine, also received news coverage internationally, but there was little mention of the CIRM connection. Other California newspapers also do not seem to have picked up on the CIRM relationship. The agency itself has not posted anything on Kuo at the time of this writing.

Major News Series on Stem Cells Coming Up in San Diego

A three-day series dubbed the "Stem Cell Race" begins Sunday in the San Diego Union-Tribune. Written by Terri Somers, the lengthy effort will cover the issue from Singapore to California.

Sunday will examine which country is leading the stem cell race. Monday will attempt to answer the question: "Why is Singapore spending millions in research?" And Tuesday addresses the issue of whether California can lead the U.S. in stem cell research.

Somers has closely followed stem cell issues and the California stem cell agency, and has written more on the subject in the last year than any other reporter in the state.

Stem Cell Snippets: Donley, Lomax and Reed

Items of some interest involving California stem cell matters.

Inside a Grant Review Session – Longtime patient advocate Don Reed, on his blog stemcellbattles.com, has a heartfelt look inside a session that reviewed grant applications for spinal research. Reed sits on the review committee. Reed also writes in opposition to more public disclosure in the CIRM grant process.

Whither Donley? -- Beth Donley, the longtime counsel for WARF, has resurfaced in a stem cell start-up. Donley, who served notice last spring that California would have to pay its stem cell dues to WARF, is the CEO of Stemina Biomarker Discovery Inc., which aims to use stem cells to develop tests for diseases. Reporter David Wahlberg of the Wisconsin State Journal has more here.

Nonproliferation -- The California stem cell agency received some attention at a chemical and biological weapons nonproliferation program in Monterey. Geoffrey Lomax, senior officer for medical and ethical standards at CIRM, spoke at the program, and the Monterey Herald covered the talk. The report by Kevin Howe can be found here. Lomax did not blow the dome off the Capitol, so to speak.

A New Feature: Labels

We have added a new feature to items on the California Stem Cell Report -- "labels" that can be found at the end of the most recently postings. The labels act as keywords. By clicking on them, you can find all the items that have labels on them. At this point, they do not include any items earlier than this week, but we are looking into placing labels on some earlier items. If there are particular subjects on this blog that you would like to see labelled, please send me an email at djensen@californiastemcellreport.com.

Murder Mysteries and Stem Cells

A couple of California novelists have dipped into politics and stem cells and come up with a thriller involving the death of a hard-nosed female state legislator.

The authors are Jonathan and Faye Kellerman. Their book, "Capital Crimes," consists of two novellas. Here are a couple of commentaries on the effort. First from Bookgasm and then Amazon(Publishers Weekly).

"The first, longest and best of the two procedurals is the inappropriately titled 'My Sister’s Keeper,' in which a feisty, dedicated female California state rep is found dead in her office, practically decapitated by a shotgun blast. The detectives who investigate wonder if her politics — whether public (she was a proponent of stem-cell research) or private (she was a lesbian) – have anything to do with the young woman’s demise. Following a trail whose clues include an STD and more than one right-wing nutjob, they have their answer. And then, just when we think it’s all said and done, the Kellermans throw in an extra delicious twist."

"The second collaboration by bestsellers Jonathan and Faye Kellerman (after Double Homicide) offers two thin novellas that dedicated fans will most appreciate. In the first, My Sister's Keeper, Faye Kellerman's LAPD detective Peter Decker makes an extended cameo role in an inquiry into the murder of an activist lesbian California state representative, Davida Grayson. Grayson, who was the focus of threats from politicians and members of the radical right opposed to her support for stem-cell research, is found shot to death in her Berkeley office; an uninspired pair of local police find that the dead woman's personal relationships, rather than her politics, may have motivated the killer."

CIRM Hires Top Facilities Exec

Only hours after we wrote that the impending departure of Zach Hall would make it more difficult to hire senior management at the California stem cell agency, CIRM said it has filled a key position involving its grant efforts to build scientific facilities.

Rick Keller, currently assistant vice chancellor for capital resource management at the University of California, Davis, will become CIRM's senior officer for scientific and medical research facilities as of Jan. 2. Keller has held his position at Davis for 19 years.

Keller has worked with the California legislature and the California State Department of Finance. He also was chairman of Mercy Healthcare, a subsidiary of Catholic Healthcare West, one of the nation's largest nonprofit hospital systems.

CIRM President Zach Hall said, "His experience with more than $2 billion in complex building projects will be enormously helpful to us, as we move forward with our shared and major facilities grants."

Keller's salary at CIRM was not immediately available. We will report it as soon as we obtain it.

Correction

In an earlier version of the item below, we incorrectly attributed a quote to Zach Hall. It was Bob Klein who said that he and Hall "mentally challenged each other."

Wanted: CEO For Promising $3 Billion Giveaway Program

One year ago this month the situation at the California stem cell agency was likened to the war in Iraq by a Nobel Prize winning scientist from Stanford.

Today the situation is much improved. So what better time for CIRM's president, Zach Hall, to announce that he is leaving.

Which is what he did last week. The move prompted comments that clashes with CIRM Chairman Robert Klein may have been involved, but Hall is 69 and has made it clear from the start that he did not want to hold the post over a long period of time.

Hall and Klein have butted heads. Klein told reporter Terri Somers of the San Diego Union-Tribune, "We mentally challenged each other to excel." But Hall also said said his plan to leave within six months is almost entirely personal. His wife retired earlier this year. They have a place in Wyoming. They love the outdoors. He doesn't need the money. And who needs the aggravation and long hours that came with the president's job.

Hall's work has set the stage for approval of the first round of research grants. And he oversaw preparation of the agency's now approved plan for giving away $3 billion for embryonic stem cell research. It is a far cry from last December when New York Times reporter Andrew Pollack quoted Paul Berg, the Stanford Nobel laureate, as likening the situation at CIRM to the Iraq war.

"We won the war and didn't know what to do afterward," Berg said.

Last week Hall summed up life at CIRM for the agency's directors:

“The institute has money in the bank now. There is infrastructure in place. And some of our initial organizational problems seem to be working out positively, so I think this is a good time for you to look for a new president.”

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights and a longtime observer of CIRM affairs, had this comment:

"Seems to me that by the time Zach leaves the following will be accomplished:

"Major training, research and joint research facilities grants will have been awarded.

"Major polices on IP, medical and ethical standards, and grant administration will be in place.

"A realistic scientific strategic plan will be in place that emphasizes science rather than hype.

"The role of the president and chief executive of CIRM will have been defined by Zach's commitment and high standards in a way that minimizes the possibility of excessive meddling by the ICOC chairman in the day-to-day operation of the institute.

"In sum, he'll have done a heck of lot to get the fledgling state agency off the ground and functioning in a productive way. Not at all a bad time to pass the torch to a younger leader."

Jesse Reynolds of the Center for Genetics and Society, another regular observer of the agency, said,

"I was surprised when he took the longer-term job in the first place, so I am not really surprised now. His can't be an easy job."

CIRM seemed to have difficulty in finding a president back in 2005 which is one reason that Hall agreed to serve longer as president. Now the agency has the task of starting a new search, although it presumably could go back to the list it had worked on then. The job is likely to seem less risky, but the agency has structural problems involving the president's job that cannot be changed short of another vote of the people. Those involve overlapping responsibilities with the chairman.

Klein, however, indicated to reporter Somers that he may be leaving in 2008, setting the stage for a different sort of relationship between a new president and new chairman. Somers wrote that Klein, who works without a salary, said "he planned to stay probably another year so he could contribute his real estate and facilities expertise when the institute is expected to award large grants for the construction of new research facilities."

The Oversight Committee took no action last week on setting up a search for a new president since the matter was not placed on the agenda in advance as required by state law. The next meeting of the group is not scheduled until February, but presumably the old presidential search subcommittee could reconvene quickly. It also seems reasonable to assume that some work is already underway to prepare for a new search, either on Klein's part or other folks at the agency.

Hall's departure overshadowed the announcement of the resignation of Mary Maxon, deputy vice chair of the agency. She has been instrumental in putting together CIRM's proposals on the critical intellectual property policies. Maxon has been with CIRM since the beginning. She noted arduous nature of work at CIRM. "It's been like three jobs in one," she told Somers.

Hall's announcement does raise the level of uncertainty at the tiny agency (roughly 20 staffers) at a time when stability seemed to be increasing. It is likely to make it more difficult to recruit other top level people, such as the chief legal officer and senior facilities officer, which are among four positions that agency hopes to fill soon.

Hall brought a steady hand, good humor, common sense and good science to a young and struggling organization in its formative years. All qualities whose absence can be sorely missed.

(Here are links to other stories on Hall: Rebecca Vesely, Oakland Tribune; Mary Engel, Los Angeles Times; Carl Hall, San Francisco Chronicle, and The Associated Press.

(Editor's Note: An earlier version of this item incorrectly attributed the "we mentally challenged each other" quote to Zach Hall. It came from Bob Klein.)

Hook Down in the Pearl of the Pacific

Like the the spawn of Godzilla, there is no getting rid of Hopalong and its hardy crew of two(your humble correspondent and his magnificent wife). We arrived about noon on Sunday in Mazatlan following three nights at sea. We nearly killed each other on 2.75 occasions. But we have learned once again lessons of the sea.

First, take a day sail – following an extended layoff from the sea -- before you set out on a three-day passage, no matter how many sea miles you have under your personal flotation device. A boat that hasn't been sailed for months needs to be rechecked better than we did. So does the crew. Then you don't have to wrestle with lines and knots while hanging from from a precarious perch that might pitch you into the plunging seas many miles from shore.

After a long layoff, be prepared for equipment to fail. A leak popped up from our rudder post when we were about 100 miles out. Crawling under the cockpit sole with two 1/2-inch wrenches to attack the steering quadrant took care of that.

Then there are the problems that you can't fix, such as the ones with the Alpha autopilot, which became crankier than the crew and yawed unmercifully. Sleep was nearly impossible as the boat rolled in response. That was unfixable because Alpha refuses to disclose the secrets of its autopilot, which cannot be opened without actually breaking something (as in cracking open a part) on the $3,000 device.

Now for good news: We successfully performed the most important task of a sailor -- listening to Mother Nature. She tells you when to sail and when not to. Our passage took us three days. Another sailboat of the same size left the same port we did, but seven days earlier and just arrived here a few hours before us. The difference is that the other boat was so beaten up by nasty waves in the Sea of Cortez that they had to put into shelter on two different occasions and wait until the sea had settled down.

What does this have to with the California stem cell agency, the subject of this blog? Really nothing. But we can tell the folks at CIRM that timing and patience are important ingredients in success. Luck too. Stay tuned for hot stuff on stem cell affairs – as soon as I catch up on all the events that occurred while we were at sea.

(Mazatlan is known as the Pearl of the Pacific with the highest lighthouse, as I recall, on the west coast of North America. Great banana coconut cream pie (spelled pay in Spanish) at Pedro y Lola's in Old Mazatlan, as well.)

Hoisting the Hook

The California Stem Cell Report will be in the middle of the Sea of Cortez for about the next week, making it impossible to file reports. We will be on a passage from the Guaymas area to Mazatlan, both of which are on the mainland of the west coast of Mexico.

By popular demand (at least one or two requests), we are providing a few more details of the cruising life, as it is known. This passage will involve at least four nights at sea, perhaps more. The entire crew of our vessel, Hopalong, consists of two persons. We stand watches 24 hours a day while we are at sea. This is required by maritime law as well as by common sense. There are other vessels out there. Some of them are not lighted at night. Others, including large commercial ships, simply set their autopilots and proceed without keeping what is known a proper watch. So we must stay out of their way.

Our watch schedule consists of three hours on, three off during the dark hours. That means one person tries to sleep while the other keeps an eye out. During daylight, we keep a six-on, six-off schedule, but this time of year does not provide 12 hours of daylight. We also have an autopilot that takes care of the actual steering for us. Hand steering becomes tedious at the very least and sometimes arduous under rough conditions, although we hand steered for 2,000 miles one year when our autopilot was down. Those were not consecutive miles but parcelled out over a period of months. I once made a passage from Hawaii to San Francisco, which involved hand-steering nearly the entire distance on a Santa Cruz 40 called Gandy Dancer. However, we had a crew of six, which made life much easier.

We hope to be filing reports again in a week or so from Mazatlan.

Newspapers Take a Whack or Two at CIRM

During a week when the California stem cell agency might think it should be receiving some kudos, it has taken a couple of stiff shots in the media.

On Thursday CIRM's Oversight Committee is expected to approve its strategic plan for spending $3 billion on embryonic stem cell research. It is a remarkable document, the result of many months of work and involving ideas and suggestions from hundreds of persons, including the top scientists in the field and patient groups. The plan is a key bench mark in the life of an extraordinary agency that is unlike any other state department in the United States. In addition, CIRM represents the single largest source of embryonic stem cell funding in the world.

But some of that is what irritates its critics. Perhaps the harshest view came from Investors Business Daily, a financial newspaper with about 211,000 national circulation. In an editorial headlined "Fool's Gold Rush," the newspaper said,

"Californians were promised wonder cures if they passed Proposition 71 to fund stem-cell research in 2004. Turns out they have bought a $3 billion jug of snake oil."

The editorial continued:

"Activist complaints about the private sector's focus on adult and umbilical-cord stem cells have driven the state to spend $3 billion on embryonic stem-cell research — something the market won't touch, even though you can find plenty of liberal venture capitalists out there willing to pay for political campaigns with celebrity endorsers.

"The only thing this amounts to is a boondoggle for voters — fool's gold the private sector had already panned for and rejected, having found the truth out first."

The emphasis on the results of adult stem cell research echoes the party line from the foes of ESC research. The newspaper also quotes the LA Times piece earlier this week. That article has been widely cited online around the country by ESC opponents. The business newspaper piece is also surfacing rapidly on anti-ESC web sites.

The Sacramento Bee, which has not said much recently about CIRM, published an editorial today that pressed for more public disclosure from the agency, a theme the paper was early to emphasize. The Bee, which has about 331,000 circulation in California's capital, said,

"...(I)t remains baffling why the institute can't be completely transparent and publicly reveal the financial interests of its grant reviewers. Scientists regularly disclose such conflicts when presenting papers at conferences. They should do so when making recommendations on grants that involve millions -- and potentially, billions -- of taxpayer dollars.

"The institute has made some good progress this year, including adoption of a strategic plan that sets realistic goals and lowers the inflated expectations of the Proposition 71 "countdown for cures" campaign. If institute leaders could take another step and come clean about internal conflicts, they could go a long way toward securing the trust they have risked squandering the last two years."

CIRM Watchdog Receives $100,000 Grant

The California stem cell agency is not the only group with good financial news this fall. The Foundation for Taxpayer and Consumer Rights has come up with a $100,000 grant to continue its work attempting to influence CIRM.

John M. Simpson, stem cell project director for the FTCR, said today that it has received the cash from the Nathan Cummings Foundation for 2007. The money will go to FTCR's Stem Cell Oversight and Accountability Project, which was also funded by Cummings this year.

Simpson told the California Stem Cell Report:

"We've tried to be constructive critics of the California Institute For Regenerative Medicine as this important groundbreaking state agency got off the ground, holding its staff members and overseers to the highest level of transparency and accountability. With $6 billion of taxpayers' money at stake and with the agency's built-in, but legal conflicts of interest, we're gratified to be able to continue our work in behalf of all Californians to ensure they benefit from the research they are funding."

The Cummings Foundation has a $500 million endowment that originated with Nathan Cummings, the late founder of the Sara Lee Corp. It has a wide range of activities including "humane health care."

Interestingly, the foundation's website quotes Nathan Cummings as saying:

"Nothing will ever be accomplished if all possible objections must first be overcome."

Sounds like a motto for the stem cell agency as well.

Affordable Access to Stem Cell Cures Hits Hard Sledding

The latest move to ensure the affordability of stem cell cures developed by California-financed research faces opposition from both the California biomedical industry and one of the chief advocates for widespread access.

John M. Simpson, stem cell project director for the Foundation for Taxpaper and Consumers Rights, said the proposed policy to be considered this Thursday by the CIRM Oversight Committee falls "far short of ensuring that all Californians will have affordable access to the therapies, drugs and cures that their tax dollars fund."

CIRM's latest access effort is linked to a new and untested law. Called the California Discount Prescription Drug Program, it was opposed by the California Healthcare Institute, which represents the state's biomedical industry. One law firm, Arnold and Porter of Washington, D.C., which has a large health industry practice, wrote about the law:

"California’s attempt to lower drug prices, by threatening drug manufacturers with prior authorization requirements, will likely face legal challenge in federal or state court. Absent a successful legal challenge, the threat of prior authorization requirements may force most drug manufacturers to the negotiating table."

Simpson's group has been nearly alone in actively advocating affordable access to the results of California stem cell research. He responded with the following when the California Stem Cell Report asked him about the access/intellectual policy proposal coming up later this week:

"The proposed for-profit (intellectual property) policies -- like the non-profit polices -- fall far short of ensuring that all Californians will have affordable access to the therapies, drugs and cures that their tax dollars fund.

"There is an appropriate formula for a payback to the state if taxpayer dollars fund discoveries that produce a revenue stream. The plan appears to strike a reasonable balance between capping the payback so companies know their potential liability and provisions that increase the state's share if there is a true 'blockbuster' discovery. The provision that Californians get preference in the event of a limited supply is only fair since we are funding the research.

"But there must be a provision to preclude the possibility of egregious profiteering. If prices are unreasonable, the state through the attorney general must have the right to intervene -- 'march in' -- and remedy the situation. There must be a reasonable relationship between the public money invested and the price that is charged.

"What must be be prevented is the Genentech situation. The National Cancer Institute provided $44.6 million to develop the cancer drug Avastin, yet Genentech set the price at $100,000 a year.

"Another troubling aspects about the for-profit policy is that it provides that there will be a discount on therapies purchased in California with public funds without spelling out the mechanism for reaching the discount. The devil will certainly be in the details.

"We see that in the non-profit regulations. The original policy called for selling drugs and therapies at the federal Medicaid price. Under incessant battering from the so-called California Healthcare Institute – actually nothing but a shill for the biomedical industry -- the regulation before the ICOC Thursday has been watered down to cover only drugs and only through the California Discount Prescription Drug Plan. It doesn't cover all purchases made by publicly funded health plans. They pledge to amend the regulation to include therapies when a mechanism is worked out, but with CHI in the picture I am frankly worried."

CIRM's affordability language says:

"As a consequence of expenditure of the 'first dollar' of CIRM funding, the for-profit awardee organization agrees to provide a plan to provide access at the time of commercialization to resultant therapies for uninsured California residents.

"In addition, the awardees will provide the therapies at a discount price to residents whose therapies are purchased in California by public funds. For drugs generated as a consequence of CIRM funding, awardees agree to provide drugs at prices negotiated pursuant to the California Discount Prescription Drug Program (commencing with California Health and Safety Code section 130500, et seq.) to eligible Californians under that program. Awardees also agree to provide discount pricing for therapies in addition to drugs that result from CIRM funding.

"In the unfortunate event of limited availability of therapeutic products resulting from CIRM funding, awardees agree to give preference to Californian residents unless prohibited by law and whenever feasible. If an awardee is unable to grant preference to Californian residents, the awardee agrees to submit a statement of justification to CIRM."

The latest legislative analysis of the prescription drug measure says:

"According to the author, this bill is needed because Californians, especially those with no drug coverage, continue to pay some of the highest costs in the world for prescription drugs. The author states that this bill uses the state's purchasing and negotiating power to help Californians cope with the rising cost of prescription drugs by creating a drug discount card program for state residents. According to the author, despite the skyrocketing cost of drugs, to date the state has done little, compared to other states, to help residents afford their medication."

Both industry and health advocate groups opposed some facets of the legislation for different reasons. You can read a discussion of those concerns in a Senate staff analysis.

Here is a piece by Health Access California on the new law.

Here is the full text.

How Funny is ESC Research?

This you have to see.

Eve Herold, author of a book called "The Stem Cell Wars," is going to appear tomorrow on the Daily Show with Jon Stewart. Generally folks who lean towards positions favored by Stewart (and this includes Herold), receive easy treatment with only minor battering. But it does sound like it is worth checking out.

CIRM Moves to Clean Up Audit Issues

The performance audit requested by former Sen. Deborah Ortiz is already having an impact on the the California stem cell agency.

On Monday, CIRM's Governance Subcommittee approved a number of changes in its policies that seemed to be needed as a result of the state auditor's work. The full audit is not expected to be officially released until March.

The changes deal with contracting, travel and other policies.

Dale Carlson, chief communications officer for CIRM, told the California Stem Cell Report:

"We decided to address issues raised in (the audit) process to date, rather than wait for the final report. Our objective is to run a tight ship. If we can eliminate ambiguities, we'd prefer to do so sooner, not later. The problems are relatively minor, evidence of an agency that is young and new to the detailed requirements of travel and contracts applied to established government entities. Better to uphold the highest possible performance standards now, before signficant resources are placed in our trust. We want to be a model agency."

We can also say that it is good PR as well as good management to take care of this kind of stuff before it winds up as a bone of contention in a critical audit.

CIRM is heavily dependent on outside contractors because of its small staff. These changes seem appropriate but still allow considerable leeway in letting contracts without bids. While the bidding process does not guarantee good value, negotiated contracts can also lead to abuses. How all this shakes out will depend on the skills of CIRM staffers in dealing with outside contractors, which can be a real art.

Here are links to the proposed new policies which were approved unanimously and sent along to the Oversight Committee for action later this week. Travel.
Contracting.

The Loss of CIRM's Friendly Critic in Sacramento

The California legislature reconvenes Monday in Sacramento minus its chief advocate for embryonic stem cell research.

Her absence will not well serve the California stem cell agency, although its chairman, Robert Klein, probably has a different view. He labelled her an "ongoing threat" in a harshly worded screed earlier this year.

While it is impossible to fully determine the roots of his animosity, Klein and the agency are losing a valuable asset with the departure of former Sen. Deborah Ortiz, D-Sacramento.

She was the one of the earliest and strongest advocates for stem cell research in California and played a key role in the conceptualizing Prop. 71. Following its passage, she understood some of its failings and began to work to correct them. But Klein did not welcome the attention and stiffed the Senate Health Committee, which Ortiz chaired, during a session examining the research agency.

It is natural to bridle at one's critics. And sometimes their motives are mixed. But in the case of Ortiz, she was a friendly critic, one who supported CIRM but also understood its imperfections and the political risks that they continue to pose.

Having powerful friends in politics and government is important for any state agency. Otherwise a department can become fair game for the genuinely malicious. A friend such as Ortiz can provide important guidance to governmental novices as they attempt to navigate the tricky byways of the Capitol. But most importantly a powerful legislator can deflect truly harmful fire by taking an agency under wing.

Perhaps one of the best known examples of a friendly critic was Harry Truman when he was a U.S. senator in the early 1940s. His committee of one exposed examples of poor military training, waste and fraud. Folks in the Roosevelt administration did not care for this. But ultimately Truman earned appreciation from within the administration. He was a Democrat and a friendly critic. Problems with the war effort? Well, the Roosevelt administration could say, "Harry's on top of it." Harry took the wind out of the sails of many of those who could have played hob with FDR's plans.

The stem cell agency enters a new stage Monday in Sacramento. It has no obvious or powerful champion or friendly critic. That may well change as legislators settle down for their new session. But ESC research is a complex field, tricky politically and governmentally. Ortiz had mastered those complexities. She will be difficult to replace.