Were Some Scientists' Concerns about CIRM's Claims Worthy of Note?

If the California stem cell agency had its druthers, no one would know that there is a dissenting view about its role in the San Diego research that led to clinical trials on a treatment for a blood disorder.

The $3 billion agency has stoutly defended its claim and bolstered its statement with additional evidence, following questions by the California Stem Cell Report.

However, the agency would have preferred that no complaints were publicly raised and nothing written about them if they were.

We first reported the matter on April 15. We are writing today not to rehash the substance of the complaints, but to share with our readers some of the reasoning behind our decision to report the story and to discuss a few of the nuances of how the media work.

CIRM's position is that our item concerning CIRM's original statement relied on a single, anonymous source and would not have been carried by most newspapers. They are partially correct on that point. We did use one anonymous source – "at least one well-regarded, California stem cell researcher" was the phrasing. We had two, but the other one did not go into the details of the issue. We did not want to characterize both as having identical positions. The item also referred to "concerns among some stem cell scientists." But because of the use of a single, anonymous source, many newspapers would not have carried the story as matter of policy.

Anonymous sources usually have an agenda, sometimes one that is hard to detect. Anonymity protects the source from having to take public responsibility for his or her words. We weighed the possibility of not writing about the concerns of these scientists, but decided to proceed.

The scientists' position was supported by evidence; it was not just one person's opinion. If these two were concerned, undoubtedly many others were as well. There is an axiom in business that for every one complaining customer, nine more exist who are unhappy but who are silent. That axiom seems to apply in this case. Finally, California researchers are loath to publicly criticize CIRM. Who wants to offend the three-billion-pound gorilla and risk losing its financial support?

The question appeared significant as a part of the culture of science. It dealt with the credibility of the agency. CIRM's role was regarded as so important that it merited enthusiastic comment from Gov. Arnold Schwarzenegger -- a move presumably promoted by CIRM. The issue also went to the more general question of hype involving embryonic stem cell research. The agency itself, stem cell research advocates and opponents all have warned repeatedly about dangers of exaggeration and promising too much in this highly charged field.

Since the story has appeared, we have learned of more scientists who agree with the essential points made by our sources.

One said,

"The problem with the original CIRM (statement) is that it referred to the SEED grant, which was funded only weeks before the paper was submitted and dealt with an entirely different disease and... was specified by the RFA to be specifically for human embryonic stem cells which are not at all involved in the UCSD experiments....

"They (CIRM) did overstate it and ... it is embarrassing that the Governor's office picked this up as a first example of CIRM's success. It would have been much better to say that CIRM is proud to be associated with such an outstanding success and to feature something about the trainee."

Another said,

"It does all of us a disservice to pretend that CIRM was responsible for the initiation of a clinical trial when every scientist and biotech manager knows that it is simply untrue."

As mentioned earlier, many newspapers would not have carried the story because of policies regarding the use of anonymous sources. Over decades of experience as a newspaper editor and reporter, we have seen those policies, along with others, paralyze newspapers. They know a story is factually accurate, but because people are afraid to speak up and the subjects of stories stonewall and delay, the stories never run. As a result, the public debate suffers. In the case of the CIRM statement, however, the story would not have reached that level. The subject would not have been pursued by mainstream newspapers because it would have have been deemed too arcane and picayune for the general public. However, the issues raised by our sources are important to our tiny, but deeply involved band of readers, who range from Korea to the United Kingdom.

The California Stem Cell Report is a blog and fundamentally a matter of the opinion of yours truly. Many blogs are nothing more than opinion. Over the years, however, we have taken to reporting stem cell news in a more traditional fashion because of the lack of hard information in the media about CIRM affairs. We have also engaged in analysis and commented negatively and positively about how CIRM is spending $3 billion of public money, virtually free from normal governmental oversight. It is a unique endeavor that has had a far-reaching and positive impact on the national and international stem cell scene.

We think California's unprecedented program is worthy of considerable attention. We will continue to offer a home to those who are willing to make thoughtful comments on its performance – even anonymously.

(We provided an advance copy of this commentary to CIRM and told the agency that we would carry its comments verbatim, if it chooses to offer any. Providing advance copies of articles and offering opportunities for verbatim responses are virtually unheard in the mainstream media.)

Fresh Links

We have added The Niche and Nature Reports Stem Cells to the links on this Web site, a long overdue addition. They are very much worth reading. We have also updated the link to Consumer Watchdog(formerly known as the Foundation for Taxpayer and Consumer Rights).

Please let us know if you know of Web sites that you would like to see added as links.

Growing an Arm, a Leg and an Ear

Some of you may have wondered about the "Veterans for Cures" effort by Robert Klein's private advocacy group mentioned in the item below.

Here is what it is likely linked to – a $250 million military effort to grow body parts or at least the thinking behind it.

U.S. Army Surgeon General Lt. Gen. Eric Schoomaker (see Defense Department photo above) earlier this month told reporters about how researchers are growing a new ear for a Marine, using stem cells from his own body. Reporter Lisa Burgess of Stars and Stripes reported that the Schoomaker said,

"It's like baking a cake."

So far none of the military cash is slated to go to California, but that could change as researchers here see the potential for grant funding.

Here is another piece on the Defense Department program on a blog by a Belgium consulting firm, Pantopicon.

Fresh Comment

Marcy Darnovsky of the Center for Genetics and Society has left a new comment on the Flamm item below. Among other things, she says there were a number of concerns with the Cha grant that were not mentioned in the item about Flamm. She is absolutely correct. We also did not mention that CIRM's scientific reviewers had no idea of the controversy surrounding Cha when they approved the grant. The scientific reviewers knew the name of the applying organization at the time of the review but it was kept secret from CIRM directors when they later ratified the reviewers' decision in public session. That secrecy is part of the official CIRM process. One CIRM official told us later that the Cha grant would not have been approved by the scientific panel if they had been informed of the controversy.

Klein's Private Group Plans Expanded National Stem Cell Push

Americans for Cures, the private stem cell activist group tied to the chairman of California's governmental stem cell agency, is embarking on a new, 50-state strategy to beef up efforts to "pass pro-cures legislation and defeat anti-cures legislation."

The advocacy group, which says that it does not perform lobbying, says it is setting up affiliates in each state and wants to hear from persons who want to help out (write inform@americansforcures.org).

Complete details for the national effort are being worked out, but Americans for Cures plans to create a Web page for each state affiliate (here is a sample) along with a rundown on the status of research and that state's laws. The affiliate would be "a single point of contact in each state, and may be one person or a group. That point will be the ‘network hub' for stem cell advocacy, to keep us informed, and to organize in the affiliate state," the co-directors of the group, Amy Daly and Constance McKee, said in an email to their supporters.

The group is also planning a "Students for Cures" group and a "Veterans for Cures" group.

The chairman of CIRM, Robert Klein, is also president of Americans for Cures, which operates out of the offices of his real estate investment banking firm. It is unusual for a top state official to lead a group that solicits possibly tax-deductible contributions and attempts to influence government policy and legislation in the same area as his agency. More than one critic has called on him to resign from one of the posts.

(On a slightly different subject, Americans for Cures' new website has some videos involving persons with a variety of ailments. We watched the Alzheimers segment. It was quite powerful.)

San Diego UT: Down with Gliders, Up with ESC

"Lamentable in the extreme" – that's how the San Diego Union-Tribune characterizes the opposition of glider airplane fans to the $115 million stem cell research facility proposed in La Jolla.

The lab is being planned by the San Diego Consortium for Regenerative Medicine, which wants $50 million from the California stem cell agency to help build it.

An editorial in the San Diego paper this week cited the "enormous potential" for development of therapies at the laboratory and said,

"It would be a tragedy of enormous proportions if glider advocates succeeded in snuffing out this promising initiative."

It should be noted that embryonic stem cell research is a hot issue in the San Diego area, which has a strong, conservative element. The newspaper's editorial on behalf of the consortium did not contain the word "embryonic," which we assume is deliberate, although the newspaper has supported embryonic stem cell research in the past.

The editorial also contained more details on the opposition. It said:

"The Associated Glider Clubs of Southern California and the Torrey Pines Soaring Council are attempting to kill the project because it would be built on North Torrey Pines Road near the Torrey Pines Gliderport(see photos from the Associated Glider Clubs). The unpaved airstrip, on land owned by UCSD, is used intermittently by glider pilots, while a larger number of hang-gliders use the nearby cliffs to launch into flight over the Pacific.

"The new research lab, about 60 feet tall, would have no impact on the hang-gliders. But there is fierce disagreement over whether it would interfere with conventional glider operations, which are relatively few and scattered throughout the year.

"Opponents claim the new building would force closure of the gliderport, an assertion they also made unsuccessfully in their bid to prevent UCSD from building a 14-story dormitory on a nearby parcel. Supporters of the lab point out, however, that it would be no taller than the surrounding eucalyptus trees, which glider pilots have been negotiating for years. An environmental impact report compiled for UCSD concludes the lab would not prompt the end of glider operations, but that it could require pilots to alter their flight patterns. In the end, both the California Coasstal Commission and Caltrans' aeronautic division must issue permits for the lab's construction."

The newspaper also printed two letters concerning the project , including one from Rolf Schulze, president of the Associated Glider Clubs of Southern California. He commented on the meeting Monday night on the environmental impact report for the laboratory, which the newspaper did not cover. Schulze said:

"Some speakers in opposition to the location of the stem cell facility not only mentioned their vote for the stem cell initiative in 2004 but also their personal interest in the anticipated benefits of such research due to their own, or a relative's illness, which could perhaps be cured.

"UCSD owns many other nearby sections of land that would be even more suitable for the stem cell facility, while not resulting in the destruction of a world-renowned and historic aviation facility used by Charles Lindbergh and many other aviation pioneers."

Chippewa to San Francisco: The $758 Million Stem Cell Media Challenge

The Associated Press files stories every day to 1,700 newspapers and 5,000 radio and television outlets in the United States. So when it reports on California stem cell news, the stories have an impact – one that goes well beyond, shall we say, the surf-scrubbed sands of La Jolla.

The case in point is an article by reporter Terri Somers of the San Diego Union-Tribune, the most diligent biotech reporter in the state. She writes more often on biotech and stem cell research than any other newspaper reporter in the state.

But her stories usually are only seen – at least the print versions -- in San Diego, far from the key East Coast news axis of New York and Washington, D.C.

However, she wrote Sunday about a $115 million stem cell research complex proposed in La Jolla – a structure that could be funded with as much as $50 million from the California stem cell agency.

The AP decided to pick up the story – rewrite it in a much shorter version, but without crediting Somers or the San Diego paper – a standard and legal practice for the news service. The AP then sent the story out across a good portion of the globe. It appeared on websites of more than 100 news outlets ranging from Dallas to the UK. Time magazine carried it as did ABC, CBS, Forbes, the Washington Times, an Arizona TV station, a Florida newspaper, CTV in Canada, FoxNews, not to mention the Chippewa Herald in Wisconsin.

The AP missed the much larger story – that the California stem cell agency is about to set off a $758 million, stem-cell-lab-building spree, the likes of which have never been seen before in this country. But that is not to disrespect The AP, but to explain a little bit about how news works.

It takes a lot to push a story out into the national or international market. It also takes luck and receptive reporters and editors. The California stem cell agency, however, has a chance to make major headlines come May 6 when it approves a couple hundred millions of dollars to help build those nearly three-quarter-of-a-billion dollars in labs.

But CIRM can only do it by starting to prime the news pump now, alerting key reporters and editors and providing them in advance with the background needed to make sense out of a somewhat complex process: Photos, drawings, map and chart material, good quotes (not the gobbledygook that sometimes comes out of the mouths of some top CIRM officials) and referrals to knowledgeable and friendly third party experts who can explain the significance of the effort in language that readers can understand.

In California, the mainstream media has so far successfully largely ignored the lab grant program, with the notable exception of Somers. Ironically, the San Diego project, while quite substantial, is not the largest. Stanford has proposed a $200 million stem cell research center. The San Francisco Bay area altogether could see something like $400 million in stem cell lab construction if the visions dancing in the heads of the scientists materialize. But nary a peep about the magnitude of the program has been seen in the mainstream media in Northern California.

Meanwhile, Somers, who like most reporters is undoubtedly underpaid and under-appreciated, will have to be satisfied with the psychic reward of seeing her work spread, albeit anonymously, throughout the world.

Fresh Comment

A statement from Kwang-Yul Cha's attorney has been posted as a "comment" on the Flamm item below.

Stem Cell Watchdog Begins Third Year

The Consumer Watchdog group and its stem cell project director, John M. Simpson, have won another $100,000 grant to continue monitoring the California stem cell agency and to expand their efforts into other states.

The Nathan Cummings Foundation is providing the funding for the Consumer Watchdog effort for the third consecutive year, Simpson said.

The latest grant, however, calls for Simpson (see photo) to move beyond California and take a crack at stem cell research efforts in other states as well as publicly funded medical research on a national level.

The grant application said Consumer Watchdog combines "policy research and focused legal and media advocacy to ensure transparency standards, conflict of interest prohibitions, public benefit requirements and other safeguards are in place to protect consumer interests and to maximize consumer access to medical advances resulting from public funding."

Simpson, a former top level newspaper editor, ranks among the most regular attendees at CIRM meetings and has a wide range of contacts in the California stem cell community.

At the January meeting of the CIRM Oversight Committee, one member of that panel, Joan Samuelson, spoke up after Simpson disclosed his group's stem cell funding sources and plans for 2008. She told Simpson,

"I'm glad you're here.... I thank him for his hard work and contribution to what we're doing toward the mission. I think you're an important element. We need the oversight."

Flamm Wins Latest Round Against Korean Stem Cell Researcher

Remember the case of Korean stem cell scientist Kwang Yul Cha versus a California physician?

Cha sued Bruce Flamm, a Kaiser physician and faculty member at UC Irvine, for libel, contending that Flamm was engaged in a personal vendetta. The lawsuit involved published criticism by Flamm of a 2001 article by Cha and two others in the Journal of Reproductive Medicine concerning "distant" prayer and IVF success rates.

Today a Los Angeles superior court judge dismissed Cha's lawsuit. Flamm said in a news release:

"Today's ruling is a victory for science and freedom of speech. Scientists must be allowed to question bizarre claims and correct errors.

"Cha's mysterious study was designed and allegedly conducted by a man who turned out to be a criminal with a 20-year history of fraud. A criminal who steals the identities of dead children to obtain bank loans and passports is not a trustworthy source of research data. Cha could have simply admitted this obvious fact but instead he hired Beverly Hills lawyers to punish me for voicing my opinions."

Cha also surfaced in connection with the California stem cell agency when a nonprofit subsidiary of his organization won a research grant from CIRM. After the grant was approved, the media reported its links to Cha along with news about the controversy surrounding some of Cha's research. Last October, Cha's group withdrew its application for the CIRM grant.

It was not known whether Cha plans to appeal the latest ruling.

Correction

The item below incorrectly described tonight's meeting concerning the San Diego consortium's plans as a "protest" meeting. It is actually a meeting called by the consortium as part of the environmental impact process. Protesters are expected to be there.

San Diego Consortium's Stem Cell Lab Plans and How They Came About

The folks in San Diego call it a "collaboratory" – a $115 million structure to be built under the auspices of four of the world's stem cell research powerhouses.

They are the Scripps, Burnham and Salk institutes and the University of California campus at San Diego – all united under the banner of the San Diego Consortium for Regenerative Medicine.

Reporter Terri Somers of the San Diego Union-Tribune Sunday took a front-page look at the project (see drawing), which is seeking $50 million in construction funding from the California stem cell agency. It is scheduled to make decisions in early May on grant applications from throughout California that would led to $758 million in stem cell lab construction.

Somers story was chockablock with interesting stuff. She wrote:

"It took three men the scientists fondly refer to as 'the town elders' – real estate mogul Malin Burnham, Padres owner John Moores and Qualcomm founder Irwin Jacobs – to help it become a reality.

"'Without their pressure, encouragement and support, (the consortium) wouldn't have happened,' said Fred Gage, a stem cell researcher at Salk."

(Moores was a key financial supporter of CIRM, purchasing $2 million in bond anticipation notes from CIRM when its finances were tied up in litigation.)

Somers also reported,

"An out-of-state philanthropist, whom the consortium declined to identify, has pledged to donate $30 million, with $10 million paid upfront. The remainder would be in $2 million annual increments."

Somers said that Moores gave the consortium $250,000 in seed money and requested the institutes come up with $50,000 each. The 7.5 acres for the building comes from UCSD and is valued at $15 million,

She reported that collaborative efforts sometimes have had difficulty in the past, including one involving UC San Francisco and Stanford. Somers wrote,

"The difficulties arise from every institution having its own culture. Smaller institutes relish their autonomy and operating freedom in contrast to larger, more bureaucratic institutions, such as UCSD.

"Issues ranging from who will be the boss to fear of losing donations, or disputes over who will own scientific discoveries, often kill such partnerships before they start, said Zach Hall, founding president of the California Institute for Regenerative Medicine.

"'It's a testament to the vitality and sense of community that is in San Diego that this has happened,' said Hall, who is now retired. Three years ago, when putting together the strategic plan for the state stem cell institute, Hall listed fostering collaboration as a top goal.

"'For these San Diego institutes to overcome all the obstacles is a real payoff for the long-term vision that San Diego had years ago in setting aside some space for the development of scientific activities,' he said."

CIRM scientific reviewers ranked the project at the top of the 12 lab grant applications. Facilities reviewers ranked it No. 4.

However, that does not matter much to some folks who are not pleased about the project. They say it would mean the end to the Torrey Pines Gliderport, which is in the National Register of Historic Places. A meeting is scheduled for Monday night at which some of the concerns of the glider folks are expected to be aired. In Napa, some 600 miles to the north, on Wednesday night, the state Historical Resources Commission will consider whether to expand the borders of the Gliderport.

Somers story picked up some reader reaction on the Internet, which can be found at the end of her story or here. One reader complained about "greedy scientists fighting over patents." Another decried "welfare for professionals in these lean financial times." One reader suggested the lab be located inland in El Cajon to save money. Responded another reader, "All the Right Wing Christian Coalition fanatics in that town would chase them out. EL Cajon is only known for strip bars, meth dens and a nut case mayor."

(An earlier version of this item described the Monday meeting involving the gliderport as a protest meeting. The meeting is actually part of the EIR process.)

Fresh Comments

John M. Simpson, stem cell project director for Consumer Watchdog, has posted a comment on the item below. We have also posted a note concerning his item.

Klein Group Says It Does Not Lobby

The American for Cures Foundation, whose president, Robert Klein, is chairman of the $3 billion California stem cell agency, has taken issue with our description of it as a lobbying group.

Amy Daly, executive director of the group, says that it does not lobby and that the California Stem Cell Report is reporting inaccurately.

She sent along the following from co-executive director Constance McKee:

"At your(Daly's) request, I have carried out additional research on Mr. Jensen’s 'definition' that would include our work as a lobbying firm. We do not make representations directly to Congress or its committees, nor do we ask for or accept any fees on behalf of others to do so. We educate individuals as to science and issues, and suggest how they themselves can advocate for stem cell research..... I could find no legal or tax definition under which our activities could be accurately described as 'lobbying.'

"You might be interested in the Supreme Court’s narrow definition of lobbying. Clearly that is not what we do.

"'The U.S. Supreme Court has rejected congressional efforts to regulate grassroots communications as a form of 'lobbying,' on constitutional grounds. In 1953, in a suit involving a congressional resolution authorizing a committee to investigate 'all lobbying activities intended to influence, encourage, promote, or retard legislation,' the Supreme Court narrowly construed 'lobbying activities' to mean only 'direct' lobbying (which the Court described as 'representations made directly to the Congress, its members, or its committees'), and rejected a broader interpretation of 'lobbying' out of First Amendment concerns. [United States v. Rumely, 345 U.S. 41 (1953).]"

Americans for Cures is obviously relying on a narrow legal definition of the word lobbying. However, lobbying has broader meaning. Merriam Webster's Third Unabridged Dictionary notes that lobbying includes conducting "activities (as engaging in personal contacts or the dissemination of information) with the objective of influencing public officials."

The legal definition of lobbying is of great importance to Americans for Cures. Too much lobbying could lead to a loss of its nonprofit status, according to the Nonprofitexpert.com web site.

Nonetheless Americans for Cures makes it clear on its web site that its goals include influencing public policy, declaring that it seeks to help "encourage" decision-makers to fund stem cell research. Indeed, Daly appeared briefly before the CIRM Oversight Committee in January and addressed the question of how the committee should proceed in handling an attempt to overturn a negative decision on a grant application. The group's recent conference in San Francisco promised attendees that they would be taught how "key federal and state programs are funded, and what they can do to make their voices heard," including "specific actions" that advocates "can take to accelerate research and cures."

Some people thing that lobbying is pernicious. We do not. The problems with lobbying result from poor ethical practices, abuses related to power and money and the failure to consider all points of view. Citizens, businesses, nonprofit organizations and other groups can and should be deeply involved in the governmental process. The voices of all are needed in order to formulate the best laws, regulations and policies.

Fresh Comment

"Anonymous" has posted a new comment on the "not so trivial" item below.

Fresh Comment

Jeff Sheehy, a member of the CIRM Oversight Committee, has posted comment on the item below. We have posted a response to his comment. "Anonymous" has also posted a comment on the "political manipulation" item.

CIRM Says: Not So Trivial

The California stem cell agency is defending its statement last week concerning clinical trials stemming from agency-funded research and denies that it put out a press release on the subject.

The comment came from Don Gibbons, chief communications officer for CIRM, in a comment on the Consumer Watchdog web site. Gibbons' comment was directed at the Consumer Watchdog news release that said CIRM funding for the research was trivial (see item below).

Gibbons said,

"Anyone who truly understands how research labs function would not call the CIRM training grant a trivial contribution."

Gibbons continued,

"Also, it should be noted that CIRM did not write a press release or send anything to reporters."

The document put out by CIRM can be found on the "press room" section of the agency's website under 2008 "press releases."

Gibbons' entire comment can be found on the Consumer Watchdog blog under the comments section following the news release by John M. Simpson, the group's stem cell project director.

CIRM Charged with Political Manipulation

The California stem cell agency is "too eager to claim immediate results" from the hundreds of millions of dollars in research that it is funding, the Consumer Watchdog group said today.

John M. Simpson, stem cell project director for the group, said,

"CIRM is jumping on the bandwagon claiming credit for contributions that were at best rather trivial."

Simpson was commenting on the report below – "CIRM Exaggerates Role..."

He said,

"CIRM is too eager to claim immediate results. Certainly we’ll see great benefit as the result of stem cell research, but this political manipulation and hype does a tremendous disservice to all who believe in the value of this research."

Simpson's news release continued:

"Stem cell agency officials repeatedly say, ‘It’s all about the science. If only that were true. More often than not — as in this case — it’s all about appearances, hype and claiming credit."

Fresh Comment

Jesse Reynolds of the Center for Genetics and Society has posted a comment on the item below.

You can read it by clicking on the word "comments" at the end of the item. You can also make a comment by the same method.

CIRM Exaggerates Role in San Diego Clinical Trials Research, Scientist Says

The headline last week from the California stem cell agency read: "First Clinical Trial Begins for a Therapy Enabled By CIRM Funding."

The news was big enough that California Gov. Arnold Schwarzenegger issued a statement on April 7, hailing the research as a world-leading effort. The governor said,

"Stem cell research, funded by the California Institute for Regenerative Medicine (CIRM), led to the discovery of this new treatment."

CIRM Chairman Robert Klein touted "the CIRM model designed to accelerate the quest for cures." The news also received attention in some newspapers, including the San Diego Union-Tribune.

But at least one well-regarded, California stem cell researcher thinks the agency engaged in exaggeration – perhaps even "fraud" – in making the claims about the role of its funding.

The researcher, who asked not to be identified, told the California Stem Cell Report:

"It appears as though the CIRM has wrongly taken credit for supporting work published by one of its funded grantees and/or the funded grantee has wrongly given credit to CIRM for supporting their research. In either case, the CIRM’s press release on the subject is self-serving and misleading, at best. The press and hESC stem cell research supporters have already latched on to this false claim by CIRM and, as a result, are mistakenly touting CIRM’s effectiveness in the field."

CIRM has defended its statement, which said,

"Researchers at the University of California, San Diego, used a (CIRM) SEED grant from the California Institute for Regenerative Medicine to conduct stem-cell research that verified a suspect gene mutation was by itself necessary and sufficient to cause a class of severe blood diseases called myeloproliferative disorders."

The CIRM statement, which is carried under the press release section of its web site, was modified following queries by the California Stem Cell Report. The release now says that a CIRM training grant was also involved. The current version of the news release, however, does not mention that it was altered from the original.

The initial version of the CIRM statement reportedly triggered concerns among some stem cell scientists and led to one contacting the California Stem Cell Report.

The researcher said in an email:

"The press release 'First Clinical Trial Begins for a Therapy Enabled By CIRM Funding' states that 'Researchers at the University of California, San Diego, used a SEED grant from the California Institute for Regenerative Medicine to conduct stem-cell research …'. The quoted UCSD press release describes the work as involving 'human cord blood stem cells … to find whether over-expression of a single gene could drive, or initiate, the disease … that looked like PV' and says that the '…work [was] supported in part by grants from the California Institute for Regenerative Medicine…'. Both items in the UCSD press release are corroborated by inspection of the Cancer Stem article cited.

"However, the SEED grant mentioned - RS1-00228-1: Derivation and Characterization of Cancer Stem Cells from Human ES Cells – has nothing to do with cord blood stem cells or PV. The SEED grant involves hESCs and another disease altogether, CML: 'To provide a robust model system for screening novel anti-CSC therapies, we propose to generate and characterize CSC from hESC (10-18). We will investigate the role of genes that are essential for initiation of CML such as BCR-ABL and additional mutations such as b-catenin implicated in CSC propagation (19-30).'

"Thus, any claim that the SEED grant monies were used to support the published research is either in error, an over-exaggeration, or, worse, fraud.

"CIRM needs to investigate which of these possibilities is the correct one, issue a retraction of its claim, and ensure that erroneous claims are no longer proffered by CIRM or its grantees."

The research in question was conducted at the University of California, San Diego, by a team led by Catriona Jamieson. Her article in Cancer Cell said in the acknowledgments section that:

"This work was supported in part by grants from the California Institute for Regenerative Medicine and the Mizrahi Family Foundation to E.K., C.B., and C.H.M.J., the National Institutes of Health (K23HL04409) to J.G., and an unrestricted gift from Targe-Gen Inc."

When queried, Don Gibbons, chief communications officer for CIRM, said,

"Jamieson has had a post doc funded by a CIRM training grant since July 2006, so our funds helped every stage of this work through his salary. The SEED grant to Jamieson was approved in February (2007) and the Notice of Grant Award went to the institution in July. It is typical for institutions to forward fund after an NGA pending arrival of the first check, which happened in September. The journal asked for additional experiments after the initial submission of the paper, and the Seed grant helped complete those added experiments that resulted in final publication.

"The SEED grant does require that Jamieson use embryonic stem cells at some point during the two year grant cycle, but it also funds many other aspects of the science. Our scientific strategic plan does not call for just funding stem cell work directly; it calls for accelerating the field as a whole."

Gibbons later said that UCSD provided no advance funding for the CIRM grant, which was not signed off by UCSD until Aug. 31, 2007, according to another source. Jamieson's article was first submitted for publication Sept. 19, 2007, according to the source.

We asked Jamieson if she had any comment on the CIRM news release issue. She simply referred us to the statement contained in the acknowledgment section of her Cancer Cell article.

The stem cell researcher who is critical of CIRM said that "...because (the agency) perceives a need to produce results rapidly (it) has, perhaps inadvertently and perhaps not, latched on without checking the facts (although in my mind the facts are quite obvious and need little checking)."

Fresh Comment

"Vanessa" has posted a new comment on the "egg donation" comment item.

How Many Hats for Klein?

The Center for Genetics and Society is tackling Robert Klein and his "incompatible" roles as head of a $3 billion, state-of-California stem cell enterprise and his leadership of a private group that attempts to influence politicians and government leaders concerning stem cell research.

The conflicting roles are not new. They have existed since 2004 but have attracted almost no attention in the mainstream media. Klein (see photo) is both chairman of the California Institute for Regenerative Medicine (the state group) and president of Americans for Cures, which is headquartered in the office of his real estate investment business.

Writing on Biopolitical Times, the blog for the center, Jesse Reynolds, who has followed CIRM since its birth, says:

"Imagine the response if the appointed head of California’s Department of Transportation was also the leader of a highway-building advocacy group that issued statements praising the department head, attacked his or her political opponents, raised funds for allies, spread misinformation about the benefits of highways, and compiled arguments against mass transit and bicycling."

Reynold also writes:

"Not only is (Klein) juggling two incompatible roles - stem cell booster and public servant - but under his guidance, his advocacy organization has attacked his political opponents, praised his own work, and spread misleading information. "

Reynolds continues:

"After the ballot measure passed in November 2004, Klein tried to wear both hats, those of booster and of public servant. The initiative campaign transformed into the advocacy group California Research and Cures Coalition, which remained headed by Klein and operated out of his business office in Palo Alto. In response to public criticism, he quickly resigned from the organization.

"But Klein couldn't resist politicking for his cause. In 2006, a new group appeared, Americans for Stem Cell Therapies and Cures, with Klein again at the helm. Its first action was to issue a public letter smearing Sen. Deborah Ortiz (D-Sacramento) on the eve of her primary election for Secretary of State. She had been the most vocal supporter of the stem cell initiative in the state house, but was now backing legislation to reform the agency. As a taxable lobbying group, Klein's outfit raised also raised money for his political allies in the fall 2006 general election.

"Now, Americans for Stem Cell Therapies has assumed the mantle of both the California Research and Cures Coalition and Americans for Stem Cell Therapies and Cures. Two months ago, it issued a press release backing one of Klein's pet projects at the CIRM. What's more, it is extensively downplaying the potential of a new alternative to the use of embryos in stem cell research - an alternative whose ascendance would call into question the relevancy of CIRM and its use of taxpayer dollars during a time of budget crunching."

Learning How to Tell the Stem Cell Story

The private lobbying group of the chairman of the California stem cell agency is holding a two-day session this Saturday and Sunday in San Francisco and promises to help advocates learn more about how to make their voices heard.

The group is the Americans for Cures Foundation, whose president is Robert Klein, who also serves as chair of the $3 billion state of California Institute for Regenerative Medicine. It is unusual for the head of a state agency to also have his own advocacy group in the same field, as we have noted previously.

Klein and Alan Trounson, president of CIRM, are both scheduled to speak along with a number of scientists as well as advocacy experts.

The session is reasonably priced -- $100 for both days, If that is too much, it's a good bet that a call to the group could lead to assistance.

The agenda is heavily loaded towards hands-on advocacy and selling the message. We suspect it would be a good value for those who want to learn more about telling the stem cell story.

We should also note that Klein's group has a redesigned and much improved web site, which is worth checking out.

FDA Worries About Stem Cell Trials

Tomorrow the FDA begins a two-day hearing involving stem cell research and human trials. Monya Baker of Nature magazine's stem cell blog, The Niche, has some insights into the session. Among other things, she writes,

"The FDA is mainly worried that the animal tests used to assess safety problems aren’t good enough and that they won’t know until too late that the transplanted cells are causing harm rather than benefit."

It is a good bet that the California perspective will be heard at the meeting, both from CIRM and at least some of the state's biotech firms.

(Shortly after this item was first posted, we ran across a related posting from Biopolitical Times that carries a report about the problems with human research protection.)

Money Up Front for CIRM Lab Dough?

Looking for more on the Calfornia stem cell agency's lab grant program -- "the largest stem cell infrastructure component in the world?"

Take a look at an item by John M. Simpson of the Consumer Watchdog group, once known as the Foundation for Taxpayer and Consumer Rights.

He quotes Alan Trounson, CIRM president, on the size of the effort, which is now set at about $758 million, including matching funds.

Simpson also provides a list of the scores for each of the 12 applicants, with Stanford (my father and brother's alma mater) at 95 and UCLA (my alma mater) at 73.

Simpson reports that the agency is considering paying an entire grant up front if the recipient agrees to reduce the amount requested. That would be one way to deal with the $48 million shortfall in CIRM funding compared to the amounts requested. (See the "Millions Cut item.) However, it is also one way for grant recipients to play a little loose with the money.

CIRM Executive Salaries Take a Hit

Should the president of the California stem cell agency, with roughly 26 employees, be paid $300,000 more annually than the director of the National Institutes of Health, which has nearly 19,000 staffers?

No, according to the Consumer Watchdog of Santa Monica, Ca. Its stem cell project director, John M. Simpson, says,

"CIRM's salaries are ridiculously out of whack."

Writing on the blog of the Consumer Watchdog, a group once known as the Foundation for Taxpayer and Consumer Rights, Simpson offers as the chief support for his view the following salaries for NIH executives:

"Elias Zerhouni, Director, NIH: $191,300 (increased in January from $186,600)
John Niederhuber, Director, National Cancer Institute: $247,500
Francis Collins, Director, National Human Genome Research Institute: $300,000
Story Landis, Director, National Institute of Neurological Disorders and Strokes: $260,000"

Simpson's figures come via reporter Jim Downing of The Sacramento Bee, who obtained them from the NIH.

Simpson compares them to the $490,000 salary earned by CIRM President Alan Trounson and the $310,000 being paid to Marie Csete, recently hired as CIRM's chief scientific officer.

The salaries have recently come under increased fire because of the state's budget crisis. Salaries of public servants are always lightning rods, even in the best of times. They are far easier for the media and the public to understand than some of the financial inequities created by Prop. 13, the property tax initiative approved years ago and that now, in many ways, cripples local government in California.

The CIRM salaries are also dwarfed by the pay of some physicians within the University of California system, who earn more than $750,000 a year. And they are tiny compared to the wages earned by some of the men at UC who supervise boys running and throwing balls. Their pay can approach $2 million annually.

Nonetheless the salaries at CIRM are a perception problem, at the very least. The agency must develop a stout defense for them, which it does not seem to currently have. Otherwise, CIRM will continue to suffer attacks from critics who find the pay levels extreme.

Millions Cut from CIRM Lab Grant Requests, Millions More Approved

California's unprecedented $758 million stem cell lab construction program completed another chapter this weekend, but fell $48 million short of fulfilling the desires of 12 universities and research institutions.

All of the 12 saw their requests cut by millions as their applications cleared CIRM's Facilities Working Group during a two-day meeting in San Francisco. None was eliminated, however, and none is likely to be eliminated when the grants come up for final action by CIRM directors (the Oversight Committee) May 6 and 7.

CIRM directors have never reversed a recommendation for funding made by their working groups.

The 12 California institutions had sought $336 million from CIRM. The Facilities Working Group approved $289 million, compared to the $262 million budgeted by CIRM. The stem cell lab construction program proposed by applicants totals $832 million, including matching funds. CIRM has proposed funding that would total $758 million, including matching funds.

CIRM said in a news release that the Oversight Committee will address at its May meeting the difference between the $289 million approved this weekend and the $262 million budgeted.

John M. Simpson, stem cell project director for Consumer Watchdog (formerly known as the Foundation for Taxpayer and Consumer Rights), attended the facilities meeting. In an email, he said the main question was how to cut money from the requests.

"At (CIRM President Alan) Trounson's suggestion the FWG (Facilities Working Group) score, which was on a scale of 100, was treated as a percentage, so for example, Stanford with a score of 95 will get 95% percent of its request. Using this method, they cut $47 million.

"Interestingly most of the applicants there seemed to think this could work. Some had been worried that entire programs would be cut."

Some of the cuts were rather large. UCLA saw its $30 million request cut by $8 million. The $50 million request from the San Diego stem cell consortium (UC San Diego, Scripps, Burnham and Salk) request was slashed $7 million. UC Irvine lost more than $7 million out of a $37 million request. (A full list of the applicants, the amounts requested, amounts recommended and total project cost can be found here.)

The Oversight Committee decisions on the funding will ultimately be made by only a handful of its 29 members, perhaps as few as eight or less. The reason is that about 18 of the directors have financial ties to institutions seeking the taxpayer funds. Those directors will be barred by law from even discussing the issue.

The CIRM news release touted the economic benefits of the construction program. Marie Csete, the agency's new chief scientific officer, said the grants will help to build "optimal facilities for our scientists and will extend California's leadership in stem cell science."

As far as we can tell, no mainstream news media carried reports on the weekend action. The agency continues to receive little notice from California newspapers and even less from the electronic media.

The Facilities Group met in public session, as it did on a previous round of lab grants. However, scientific reviews of the programs were conducted behind closed doors by scientific reviewers who do not publicly disclose any potential conflicts of interest.

(Editor's note: Our figures differ slightly from CIRM's. The discrepancies appear to be related to rounding.)

CIRM Bill Moves on in California Legislature

Legislation aimed at California's unprecedented $3 billion stem cell research effort this week easily cleared its first hurdle -- as expected.

The measure by Sen. Sheila Kuehl, D-Santa Monica, now moves on the state Senate Judiciary Committee, where it is likely to win approval as well. Kuehl is part of the Senate leadership and chair of the Senate Health Committee, which unanimously approved her bill, SB1565, on an 11-0 vote. Co-author of the bill is Republican George Runner of Antelope Valley, who is part of the GOP Senate leadership.

The legislation is designed to provide affordable access to therapies developed with taxpayer funds and correct problems associated with conflicts of interest at CIRM.

The legislative staff analysis of the bill said that its authors believe

"...that, given CIRM/ICOC's unique formation as a public entity, the level of public investment--$3 billion in bond funds that will amount to a General Fund expenditure of $6 billion (including interest), and the close-knit nature of the scientific community, CIRM and the ICOC should be thoroughly scrutinized by an independent body to ensure the highest level of public trust and confidence."

CIRM has opposed similar legislation in the past, but according to John M. Simpson, stem cell project director for Consumer Watchdog, the group formerly known as the Foundation for Taxpayer and Consumer Rights, CIRM is now taking a more measured stand.

Simpson, who attended the hearing earlier this week, reported:

"CIRM's Interim Director of Legislative Relations Sue North told the Senate Health Committee, 'We have no formal position on the bill and hope to resolve any differences administratively.'"

Simpson opined on the Consumer Watchdog blog that the CIRM position marked an improvement from the days when CIRM Chairman Robert Klein declared that one legislator who was also a longtime supporter of stem cell researcher was an "ongoing threat" to CIRM.

Consumer Watchdog supported the CIRM legislation but said it did not go far enough. Simpson said,

"We need a provision that allows the state attorney general to intervene if drugs or therapies funded by the stem cell agency are priced unreasonably. We've seen too many cases where companies benefit from publicly funded research and then set prices at obscene levels. They act like socialists when seeking research funding but are greedy capitalists when there are profits on the table."

Also supporting the measure were American Federation of State, County and Municipal Employees (AFSCME), the California Alliance for Retired Americans, California Nurses Association, Center for Genetics and Society, Gray Panthers, Greenlining Institute and the Pro-Choice Alliance for Responsible Research

CIRM Seeking Egg Donation Comments

The California stem cell agency has prepared a draft of guidelines for reducing risk in connection with the donation of human eggs for stem cell research and is seeking comments on them from the research community and others.

The draft can be found here. A related document concerning the history of the guidelines and their purpose can be found here.

In addition to general remarks, Geoff Lomax, senior officer for the CIRM Standards Working Group, is asking for comments on the following:

"The utility of the guidelines for reviewing studies proposing to obtain oocytes for research

"The consistency of the guidelines with current clinical protocols and standards of care

"General feasibility considerations with the draft guidelines."

The impact of these guidelines will go well beyond California, which is currently in the global forefront of setting standards for human embryonic stem cell research. Seeking comment at early stage and posting the information on its web site serves CIRM well, opening the door to all who are interested or who have something at stake.

Sailing Time-Out for Blogger

We are setting sail Saturday morning from Guaymas for Mazatlan and will be at sea for several days. So we will not have any fresh postings until late next week.

We have been on the hard, as the maritime term goes, for far too long, performing unpleasant but necessary boat maintenance chores. It is great to be back on the water.

'Doing It Right,' Cerberus Simpson Says

Both the California stem cell agency and the Interstate Alliance on Stem Cell Research have come in for some praise from Consumer Watchdog's John M. Simpson, who has followed California stem cell issues closely for several years.

Simpson, who was once thrown out of a meeting of the interstate group, lauded it for an early posting an agenda for its meeting April 9-10 in Washington. He also remarked that CIRM has done better recently on posting materials for some of its meetings. He particularly cited Rick Keller, senior officer for Scientific and Medical Research Facilities.

Writing on the Consumer Watchdog's blog, Simpson said,

"Public policy should always be made in public. And the public must have timely advance access to what's being discussed. That's how policy-makers actually build true support for their actions. Perhaps after a few -- sometimes less than gentle -- nudges from folks like me that message is getting across in these two cases."

Bravo on Timely Posting of Lab Grant Documents

The California stem cell agency today posted on its web site the staff analysis and other key documents in its $758 million lab grant construction program, a full week ahead of their scheduled public review.

Congratulations to CIRM and its tiny staff for the timely posting. It well serves the agency, interested parties and the public, providing ample time to review the complex documents and prepare comments, if so desired. Posting and preparing the material is no small task. The documents are large and intricate. And no one wants to make mistakes.

In addition to the staff analysis of the applications, the newly posted material includes lab planner's evaluations and applicant comments. The applications in CIRM's single largest round of grants will be evaluated at a two-day session of the Facilities Working Group in San Francisco, beginning next Friday,

CIRM Seeking IP Lawyer and Presidential Consultant

Attention IP attorneys and anybody – almost – who wants to tell the president of the California stem cell agency what to do.

CIRM is looking for a couple of people to come to its assistance on a temporary basis. The IP gig is part-time for six months for $150,000. The consultant to the president is scheduled for only four months fulltime for $80,000.

The IP position caught our eye for several reasons. One is that it lists an hourly rate of $150, rather low for a 15-year veteran of the biotech/IP field, which is the experience level that CIRM seeks. Another curiosity about the position: An hourly rate of $150 for 20 hours a week for about six months weeks amounts to $78,000, somewhat less than the $150,000 allotted for the job. The RFP also requires the winning bidder for the contract to cover his own "personal and business" expenses within that rate, except for "additional expenses, incurred at CIRM's direction."

The RFP highlights the nature of the legal work and management structure within CIRM, and not just because the agency is treading new ground on IP. The agency has a general counsel, who one might think would oversee the entire legal staff. However, virtually since its inception, CIRM has signed on with Remcho, Johansen & Purcell of San Leandro, Ca., for legal advice at a cost of more than $1 million.

While the reporting lines are not entirely clear, Remcho's James Harrison seems to be directed primarily by Robert Klein, the CIRM chair. On CIRM staff is attorney Scott Tocher, who once appeared to report to the president of the agency but now has been moved under Klein's control. Tamar Pachter, the general counsel, reports to President Alan Trounson via the chief operating officer. The new legal "temp" will report to Trounson and "coordinate" with the general counsel.

We ran the RFP by one observer who is knowledgeable about CIRM and IP work. That person confirmed that the hourly rate was at the low end and also indicated that the RFP was unclear about whether a firm or person was desired. Our observer also said,

"If the contract is not renewed, the attorney has still been paid to become one of the world's leading experts on stem cell IP, funding and commercialization. There is a good chance that this new-found expertise will lead to job opportunities with law firms, companies, non-profits, universities, etc. Even a law firm might be willing to discount its rates heavily to get this work to establish itself as a player in this field."

The RFP for the presidential consultant seeks a scientific professional (Ph.D.) with 15 years experience. In addition to a wide range of advice, the RFP indicates the person will be asked to develop "alternative resource opportunities for increased flexibility and productivity of CIRM research and clinical applications."

Both positions were posted just last week under "CIRM RFPs" instead of the job listings on the CIRM site. The deadline for applications is April 1 with work beginning shortly thereafter. Given the short time frame, it is likely that CIRM has candidates in mind for both positions.

CIRM is also seeking to fill the IP position permanently through its job listings. Other open positions include finance officer, scientific officer, senior administrative coordinator and communications manager.

Fresh Comment

In a new comment on the "CIRM Legislation" item below, Don Reed discusses his role as vice president of public policy for the Americans for Cures Foundation and his comments on CIRM matters.

Rabble, International Meetings and CIRM

The Consumer Watchdog group says the real problem with the International Stem Cell Forum last month did not necessarily involve CIRM's reluctance to provide cost estimates.

Instead, it involves keeping the rabble out of the meeting at a luxury San Francisco hotel.

The remark comes from John M. Simpson, who was writing on the new blog of Consumer Watchdog, which was formerly known as the Foundation for Taxpayer and Consumer Rights.

Commenting on our item below, Simpson, stem cell director of the group, says,

"What really is of major concern, though, is the fact that these meetings were closed. Supposedly the reason for that is that the ISCF is administered by the UK's Medical Research Council. The ISCF chairman is Sir Leszek Borysiewicz, chief executive of the Medical Research Council (UK). Apparently the scientists on the other side of the Pond just assume the rabble ought not be let in behind the closed doors of their scientific clubs when meeting.

"CIRM did call a late afternoon telephonic news conference -- about the worst time for any working reporter on a deadline -- only to delay the announced start by half an hour. Then when reporters called in at the newly appointed time, they were kept on hold for at least 20 more minutes."

Simpson says the amount spent does not seem unreasonable, a judgment with which we concur.

CIRM Releases Cost on International Stem Cell Forum

The California stem cell agency hosted the International Stem Cell Forum in San Francisco last month, which involved representatives of the leading stem cell research organizations in the world.

CIRM ballyhooed the event with a news release, and prior to the meeting, we asked for an estimate of the cost to CIRM. The agency declined to provide an advance estimate and said that the costs would include "paying for the meeting room at the hotel where the meeting is taking place as well as the audio visual set up and possibly some things like copies. We are also paying for 2 dinners (but not alcohol)."

In response to our queries, Don Gibbons, chief communications officer for CIRM, this afternoon reported that the cost totalled $25,912.

Tribulation for Love and Harrison

Last week did not bring the best news for two California stem cell personages – CIRM Oversight Committee member Ted Love and the agency's outside counsel, James Harrison.

According to The Associated Press, Love, who is CEO of Nuvelo of San Carlos, Ca., had the unpleasant task of cutting 40 positions out of his workforce, which is 14 more than the total at CIRM. The reason? The biotech firm is dropping "its troubled blood-thinner alfimeprase after it failed another study," The AP said. The move will cost the company about $3 million during the first quarter.

Attorney Harrison lost a big one with California's official state political watchdog, the Fair Political Practices Commission.

According to reporter Aurelio Rojas of The Sacramento Bee, one of Harrison's clients, Sen. Carole Migden, D-San Francisco, agreed to pay a record $350,000 fine for "personal use of campaign funds and inaccurate disclosure of cash payments and receipts between 2003 and 2007.

Harrison, who told us that Migden is a longtime client of his firm, attributed the violations to inadequate record keeping by her former campaign officials.

The Bee also said:

"During the FPPC's months-long investigation, the agency determined Migden illegally transferred approximately $1 million of surplus campaign funds and had already spent hundreds of thousands of dollars.
"The senator was told to stop using the money but instead sued the FPPC (in federal court) in an effort to gain access to $647,000 of the money she had not spent."

That suit is scheduled for a federal court hearing April 1.

Fresh Comment

"Anonymous" has left a new comment on the item below.

CIRM Legislation Hearing Scheduled for Early April

The latest legislation to target the California stem cell agency is set for its first hearing April 2 in Sacramento before the Senate Health Committee.

The bill is aimed at ensuring affordable access to stem cell therapies financed by public funds in California. It would also require a study of the agency with an eye to correcting some of the difficulties it has had with such problems as conflicts of interest.

The lead author on the measure, SB1565, is Sen. Sheila Kuehl, D-Santa Monica, who is chair of the Health Committee. She is not expected to have difficulty in winning approval of her bill and sending it to the Judiciary Committee.

CIRM has not taken a position on the measure, but has opposed similar efforts in the past. Last month, one stem cell activist, Don Reed, opposed the measure, calling it "another distraction, another delay." Reed also said that CIRM is "squeaky clean" although one of its directors. John Reed (no relation to Don Reed), is under investigation by the state for violating CIRM's conflict-of-interest rules. Five other directors also violated conflict policies last year by writing letters on behalf of grant applicants.

Don Reed is vice president for public policy for Americans for Cures Foundation, which is the private, nonprofit stem cell lobbying group run by CIRM Chairman Robert Klein. It was Klein, an attorney, who advised John Reed to lobby CIRM staff on behalf of a grant to his institution.

Fresh Comment

"Anonymous" has posted a new comment on the "egg shortage" item below.

Fresh Comment

Jesse Reynolds of the Center for Genetics and Society has posted a comment on the "eggs" item below. It says in part, "Some believe that stem cell lines could be derived from embryos that are specifically created for research through cloning, or somatic cell nuclear transfer. This process requires fresh human eggs. Only perhaps a dozen labs worldwide are trying, and only three or four CIRM grants have been awarded for this purpose (to my knowledge). This line of work raises concerns beyond the moral status of the embryo." To read his entire remarks, click on the word "comments" at the end of the item.

An Egg Shortage: Is More Cash the Answer?

The California stem cell agency has embarked on a sweeping review of the human egg market and the needs of researchers, some of whom are complaining that they do not have enough raw material.

The study was set in motion after Harvard scientist Kevin Eggan (see photo on left) told the CIRM Standards Working Group last month that he and his colleagues had spent $100,000 recently advertising for donors and "pursued every option" for collecting eggs with little success.

CIRM President Alan Trounson, a renown Australian stem cell scientist, said "accessing those eggs is no trivial matter." He said scientists are seeking grants from CIRM for research that may not be feasible because of the lack of human eggs.

One answer to the question of scarcity posed during last month's session is increasing the money for women who provide eggs. However, that could be considered the politically fatal "third rail" for hESC cell research. Prop. 71, which created the California stem cell agency in 2004, was approved by voters in a campaign that appeared to promise that women would not be paid for eggs. But the language of the measure is artfully ambiguous. The initiative says that it is up to CIRM directors to set

"standards prohibiting compensation to research donors or participants, while permitting reimbursement of expenses."

Currently CIRM regulations do not allow for compensation other than reimbursement of direct expenses. One suggestion that arose during the meeting of the CIRM Standards Working Group on Feb. 28 was some sort of reimbursement of expenses for women involved in IVF treatments. However, paying for IVF treatments could be construed as cash for eggs.

Not all members of the group were comfortable with the concept of paying women for eggs.

Here is an exchange from the transcript of the Feb. 28 meeting between CIRM Oversight Committee member Jeff Sheehy and CIRM Chairman Robert Klein, who led the campaign for Prop. 71 and claims responsibility for writing it:

Sheehy:

"(Prop. 71) was approved by the voters because the voters thought there wasn't going to be compensation for egg donors when they voted for it, and they didn't know we were going to go back and change it. And so in that context I think this is an issue that would be appropriate for us to study."

Klein:

"Well, I'm in a reasonably good position, Jeff, to discuss the issue of what was presented to the voters. and --

Sheehy:

"I was your average voter, Bob. I was not one of these people that was waving the stem cell flag. I can tell you that if we were going to go out and spend $3 billion buying eggs from women, I wouldn't have voted for it."

Klein:

"Certainly I wouldn't have voted for it either, so we agree. But the key here is medical reimbursement was clearly contemplated. I have gone to James Harrison (outside counsel to CIRM and who wrote portions of Prop. 71) and discussed this issue with him...."

Alta Charo(see photo on right), professor of law and bioethics at the University of Wisconsin and a member of the CIRM standards group, noted the political sensitivity of the issue of cash for eggs. She said changing the CIRM standards worked out in 2005 could be "inviting really quite draconian responses" from unspecified parties, but presumably hostile lawmakers and regulators.

What went unsaid during the Feb. 28 meeting was the fact that some have long regarded the supply of human eggs as insufficient for human embryonic stem cell research. But now that hESC research is enjoying a resurgence, the scarcity is becoming more acutely felt.

The session also did not include a direct discussion of another reality: If eggs are scarce and demand is high, somebody is going to make a business of it. It will be an unregulated business somewhere else in the world. It goes almost without saying that embryonic stem cell research is a global endeavor, a point that Klein made on Feb. 28.

The CIRM Standards meeting ended with a move to investigate the entire subject further. Bernie Lo of the University of California, San Francisco and chairman of the group, indicated the review would include availability of eggs and their numbers, researchers' perceptions of the problem, possible reimbursement of IVF treatment, use of eggs by CIRM researchers from other areas where compensation restrictions are not so tight and the grandfathering of cell lines that were derived before CIRM regulations were adopted.

The standards group will consider the staff review of the matter at some later date. We have asked CIRM when that is likely to occur.

Needless to say, this subject is complex. We have only briefly touched on a handful of issues discussed during the Feb. 28 meeting. We recommend a close read of the transcript. Most of the pertinent discussion begins on page 91.

Below are some excerpts from the transcript.

Snippets From the CIRM Egg Debate

Here are some excerpts from the transcript of the Feb. 28 meeting of the CIRM Standards Working Group concerning human egg availability.

CIRM President Alan Trounson:

"Accessing those number of eggs is no trivial matter, no matter what the opportunities are. In that circumstance the demand for the oocytes may be way beyond what we can possibly deliver in an outcome. And it may take us five years to do that. If we gave a three-year grant, that would be nonsense because the chance of deriving a cell line might be extremely low.

"That's why we've come because we have these applications sitting in our portfolio which we're questioning about how do we move forward on this, or do we sort of take them off the table and let the other ones proceed. I think it's important for you to understand that it's real-time now. We have to actually know exactly what is appropriate to do."

CIRM Chairman Robert Klein:

"From a legal point of view, I'm very concerned with the use of words here. I don't know anyone that's suggesting you make a $10,000 payment to somebody. If somebody has real cost, and they can document those costs, and they can get reimbursed for part of those costs. What's being addressed here is reimbursement for part of the cost, not a $20,000 payment to someone."

CIRM Oversight committee member Jeff Sheehy:

"If they did not think that they could get the eggs, they should not have submitted the applications. They have submitted applications, so they must believe that they can get the eggs."

Alta Charo, a member of the Standards Working Group and University of Wisconsin professor:

"Prop 71, which itself had this written in to some extent as a political matter, drove the National Academy guidelines which felt like they were already basically having to follow the California lead on the altruistic model here."

Trounson:

"I don't think it drives it forward. That's the problem."

Charo:

"Now we're in a situation, I think, where it's particularly touchy to try and revisit the compromise, putting aside whether or not it's even legally possible given the language of Prop. 71."

Kevin Eggan, Harvard stem cell researcher and member of the CIRM Standards Working Group:

"I have spent countless hours stomping around to different disease advocacy groups, tea circles, knitting circles, trying to find anyone and everyone who would donate their oocytes for our experiments, even out of the goodness of their heart because they had someone that they cared about who was affected by these diseases that we might in the very long term provide hope for.

"We spent more than $100,000 in advertising in the Boston Globe, in the Boston Herald, in the Boston area papers, in the suburbs of Boston. We have literally pursued every option. We've pursued trying to recruit donors from other parts of the United States to come to Boston to donate their oocytes for research. This will not work. In a country where women know that they can be compensated for doing the exact same thing, they simply will not, and in the face of the difficulties, I should add, it's not like they're not doing it solely because of the money, they're doing it because of the money and because it's a very difficult thing to do oocyte donation. And those two things collaborate together to create an environment in which women will not do this in a meaningful way which will allow the research to go forward.

"It was a very reasonable compromise to say we need to give up compensation because we can't afford to be assailed both from the right and the left on this position, but now we know that that compromise position is a failure. So what do we do about that? I think the fact of the matter is that it might as well be against the law if we can't do it. That's one sort of null hypothesis for years. So how to proceed in the face of that? I agree it's risky; but if we don't take the risk, then the outcome will be the same as if we take the risk ..."

CIRM Cerberus Has New 'Kennel'

John M. Simpson, the ubiquitous critic, observer and participant in California stem cell controversies, has a new employer – sort of. The nonprofit outfit he works for has changed its name. No longer will it be called the Foundation for Taxpayer and Consumer Rights. Instead it is Consumer Watchdog. You can find more about the change here.

Fresh Comments

Larry Ebert has posted a comment on the "corrections" item from March 17. We have posted a response to that item. "Anonymous" raises some interesting questions regarding the "back story" on why CIRM failed to issue a press release on the letters of intent on round two of the faculty awards(see the "$41 million" item on March 18). We have responded to that as well. You can read all of this by clicking on the word "comments" at the end of each item in question. You can also post comments yourself by clicking on that word.

Pricewaterhouse Report on Biotech Loans Available Online

The Foundation for Taxpayer and Consumers Rights has posted the $50,000 PricewaterhouseCoopers report made to the CIRM Biotech Loan Task Force last week(see item below). The numbering of the pages seems to indicate that there is more to come from Pricewaterhouse. The report is not yet available on the CIRM website.

Biotech Loan Program Eyes Matching Funds

The California stem cell agency last Wednesday considered a proposal to create a biotech loan program of up to $750 million and is expected to possibly enact it by June. Here is a report from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, who attended the meeting of the CIRM Biotech Loan Task Force in Sacramento.

"CIRM Biotech Loan Task Force members didn't learn much last week from a $50,000 consultant's report about other states' loan programs, except that nobody really seems to be doing what the stem cell agency envisions.

"Loan programs in other states aren't really comparable to California's plan members of CIRM's Biotech Loan Task force were told by Christopher Wasden of PricewaterhouseCoopers.

"The consulting firm checked out about 30 loan programs and then narrowed the list to consider 12 of them in detail. The criteria for the short-list were that the program be state funded, focused on life sciences or technology companies, primarily offered loans and had a meaningful size. The final criterion was that the program was responsive, Wasden said.

"Noting that most of the loans offered by the other states were in the $200,000 to $400,000 range, Wasden described the proposed California program as 'more ambitious by a factor of at least two.'

"In fact, ICOC Chairman Robert Klein raised the possibility of making loans as large as $50 million. Task Force Chairman Duane Roth mentioned loans aimed at pre-clinical trials of $3 million to $5 million.

"Wasden reported that the 'amount of experience with the programs is low. There have been no liquidity events and no write-offs -- yet.'

"After Wasden's report task force members discussed more details of how California's program may emerge. Roth suggested that a four-part business evaluation would be the first step. That would include:

"-- A background evaluation of the company's principals.
"-- A credit evaluation, a Dun and Bradstreet or similar report.
"-- A litigation assessment. This would not include an assessment of the company's intellectual property (IP) portfolio, but rather a check for any suits pending against the firm or its principals.
"-- An assessment of the business plan and financial feasibility.

"Klein suggested, as he has at all task force meetings, that this check could be performed by 'delegated underwriters.'

"Task force member Michael Goldberg suggested that 'higher standards of verification would be required for larger loans.'

"If the applicant met the business criteria in the first step, then the plans would be peer-reviewed by the scientific panel for scientific merit as the second step.

"During his report Wasden said that a number of the state loan programs required matching funds as a way to 'have a third party validate the management team.'

"Klein emphasized the need for matching funds if CIRM makes large loans. 'There would be a lot of other people's money at stake in the big ones,' he said.

"Goldberg asked if the length of the loans should be tied to the life span of the stem cell agency. Klein responded that at some point he expects the Legislature will 'look at CIRM and see if it performed and whether more money should be put in.'

"David J. Earp, Geron Corp.'s chief patent counsel and senior vice president, told the task force that a requirement for co-funding would serve as 'a sanity check.' Asked what he thought a Phase 2 clinical trial would cost for a stem cell therapy, he said, 'Many tens of millions, certainly larger than $5 to $10 million' that had been cited earlier in the meeting.

"Roth told the task force that he and Klein had been meeting with state legislators in an attempt to keep them apprised of the plan. He said he hoped to have a loan program policy ready to discuss at the stem cell Oversight Committee's June meeting."

Our comment: Keeping California lawmakers well-informed on this program is well-advised, particularly if Klein plans to ask them for continued funding for CIRM in a few years.

Strong Interest in $41 Million CIRM Faculty Award Program

The California stem cell agency's effort to boost "young" researchers with grants of up to $2 million has attracted 55 letters of intent, nearly as many as the first round of program last year.

The faculty awards are designed to develop relatively young and promising researchers and particularly physician-scientists at a critical stage in their careers – providing them with salary and research funding for three to five years.

The $41 million grant program comes on top of a similar program last year that drew 59 letters of intent. Ultimately, the agency gave away only $54 million to 22 researchers out of the $85 million allotted in 2007. The grants were curtailed because five CIRM directors violated the agency's conflict-of-interest policies by writing letters on behalf of applicants from their institutions.

CIRM said the letters resulted from an "innocent misunderstanding." CIRM disqualified the 10 applications involved. The directors involved suffered no CIRM penalty, although some reportedly took steps to ease the economic or professional pain of applicants who were affected.

In December, CIRM directors ordered up a second round of faculty awards in order to give another chance to applicants disqualified last year because of their deans' conflict violations.

The names of the institutions and researchers submitting letters of intent this month were not disclosed by CIRM, which keeps them secret. Only the winning applicants names are released and then only after they are approved for funding.

In response to a query, Don Gibbons, chief communications officer for CIRM, released the number of intent letters and said 31 institutions were represented. He did not provide a breakdown for numbers from academic institutions and nonprofit research organizations.

CIRM has directed applicants in the second round not to disclose whether they competed in the first. Disclosing such information in this round could mean disqualification of the applicant.

Grant reviewers, however, are not likely to have too much trouble identifying applicants who are making their second run – unless their latest applications are totally different than the first or the reviewers' memories are faulty.

Fourteen grants are expected to be approved this summer following a closed-door review of the applications by the same CIRM panel that reviewed the first round of the grants. Scientists on that panel do not have to publicly disclose their financial or professional interests. Instead their disclosures are made privately to CIRM.

The application deadline is April 3, although no one can apply unless a letter of intent has already been sent.

California's Huge Lab Construction Program Set for Public Airing

The schedule for the next step in California's $758 million(including matching funds) stem cell lab grant construction program went up today on the CIRM web site and offers a rare opportunity for the public to comment on grant applications prior to final action.

Applying for the state cash are virtually all the major players in stem cell research in California. The names of the 12 were disclosed in December in an unusual move by the agency that was aimed at helping them to raise the matching funds needed to win the CIRM cash. Over the past three years, nearly all applicants for California stem cell research funds have been shrouded in secrecy until after the grants are approved, preventing the public from making any sort of meaningful comment.

The construction grant programs are exceptions, offering public sessions during review by the facilities group.

However, CIRM meetings are in fact rarely attended by more than a handful of persons, especially those from the general public. Applicants will be out in force, however, if only to be available to answer questions and possibly plan strategy in case questions arise that might hobble final action.

The agenda for the Facilities Working Group covers two days – April 4 and 5 – at the Westin San Francisco Airport Hotel in Millbrae. The Friday session is scheduled to begin at 2:30 p.m. and run to 9 p.m. The Saturday session runs 9 a.m. to 3 p.m.

Final approval by CIRM directors is slated for early May.