Sunday, March 06, 2005

Not Everyone Buying...

An insight into the dynamics of the new California stem cell agency was presented on Sunday in an editorial in The Sacramento Bee. The headline on the piece was "Cell Break." Here is an excerpt:

"During Tuesday's meeting at Stanford University, Klein asked the committee for sole authority to respond to the (Lee-Halpern) petition, with no discussion of its merits. It was a remarkable power grab, but not everyone was buying.

"The first dissenter was Dr. Francisco Prieto, a Sacramento physician appointed to the committee by state Treasurer Phil Angelides. Prieto said the petition had "substantive points" for discussion. He was joined by Dr. Michael Friedman, another Angelides appointee who heads City of Hope, a Southern California cancer research and treatment center.

"From that point on, Klein lost control of the proceedings. The committee wasted 30 minutes debating whether to write a perfunctory response to Halpern and Lee or - horrors! - actually meet with them. The most shameful performance was by David Serrano Sewell, who suggested the petitioners were plotting a "judicial intervention." (Note to Sewell: Lee is a distinguished health official who supports stem cell research. He deserves more respect than you granted him.)

"Later, Klein tried to vest authority in a subcommittee to devise $15 million to $25 million in grants to train scientists and create "centers of excellence" for stem cell research. Dr. Claire Pomeroy of UC Davis rightly questioned this delegation of authority, and the matter was put off to the next meeting.

"What we are witnessing is the natural tension between doing things fast, and doing things right. As we have stated earlier, California's landmark stem cell research program holds enormous promise for treating diseases. But by trying to strong-arm every decision, Klein may actually be slowing down the process - by infuriating colleagues and emboldening opponents."

New Frontiers: Stem Cells and the Web

Only about one out of every five million Californians was able to make it to this month's meeting of their state's new stem cell agency.

Yet, nearly half of all the families in California could potentially benefit from programs that the multibillion dollar agency is just starting.


It may be that the old saw about the making of sausages and laws also applies to the making of a new bureaucracy. It is an untidy business, perhaps best left unobserved by the overly fastidious.

The new institute, however, is also making history with forays into the frontier of medical science. Cures or vastly improved treatment for such ailments as diabetes, cancer, Parkinsons, Alzheimers, ALS, multiple sclerosis, spinal injuries and heart disease are all part of its goals.


Its leaders have promised the highest and best standards for its science. That promise should apply as well to the openness and accessibility on the Web of the California Institute for Regenerative Medicine.


It certainly would benefit the many Californians living with the diseases targeted by CIRM. Many are not able to travel to CIRM meetings but might find them of interest if the sessions were broadcast on Web. Webcasting would be of enormous utility to thousands in the scientific community, academic world, biotech businesses as well as legislative and governmental officials.

But Webcasting should only be a start. When the Web became a reality for most state agencies, they were living in a world that had only recently abandoned typewriters. Bringing information and public records online was an expensive and time-consuming process – not to mention a frightening one for the officials who preferred life in semi-obscurity.

Today's technology allows – virtually insists – that all of CIRM's public records be available online and easily searchable. The agency has moved in that direction already with its first efforts on the Web. Much more can be done.

CIRM can readily establish new performance levels for Internet access to government agencies, since it is not hobbled with the baggage of the past. Doing so would advance the institute far along the path of fulfilling its promise of maximum openness. As CIRM Chairman Robert Klein has said, what this agency ultimately generates must be shared with the world.


The value of open Web access involving grants and research (with the obvious usual limitations) would seem immeasurable. Web access would achieve other goals as well, such as reducing staff time involved in routine phone calls and conventional mail. Given the picayune size (50 persons) of the agency's staff, that would seem something worth doing.

We must admit the possibility of the opposite result. Years ago, the advent of computers was predicted to eliminate paper in offices. In fact, paper multiplied geometrically. It could be that unprecedented openness could lead to a wave of totally unexpectedly public interest in CIRM. Not that that would be so bad.

It is not often that government agencies can make fresh starts or have new beginnings. CIRM stands in an historic position. It may be the first time that government has embarked on such a massive effort on the frontiers of biology and theology, life and death, and, yes, even sex.

Opening a frontier in cyberspace may not double attendance at CIRM meetings to as high as, let's say, two out of every five million Californians. But it would be a shame to pass up an extraordinary opportunity to set a global benchmark for openness and public access.

Readers Write

Pete Shanks writes:

"I just re-checked the Cal. Sec of State campaign database and found new data on the 71 campaign.

"As of 03/04/05, these are the numbers: Support 71 -- raised $25.1 million -- spent $34.8 million

"Oppose 71 -- raised $635 thousand -- spent $625 thousand i.e. Yes on 71 is still almost $10 million in debt and the ratio of expenditure is, gulp, 55 -- almost 56 -- to one.

"The URL is http://dbsearch.ss.ca.gov/BallotSearch.aspx (and then navigate via drop-down menus).

"It certainly seems as though the Yes on 71 people overspent badly, since they got 59% of the vote and yet ended up so hugely in debt.

"I do not doubt the sincerity of the supporters, especially the patient advocates, but I do question their judgment. (There is an element of self-interest among some of the entrepreneurs but I suspect that even they think they will be "doing well by doing good.")

"My take is that there was a frenzied feeling that this HAD to be passed at virtually ANY cost, and I wonder if there will be a backlash when cures do not appear RIGHT NOW. In a sense, the leadership -- most visibly Klein but it's broader than just him -- put themselves into a bind with the language of the Proposition, dug themselves a deeper hole with their no-quarter approach to campaigning, and fumbled an opportunity to mollify their critics after the election.

"I suspect that the money overspent -- indeed, just the money raised -- is symptomatic of a "true believer" syndrome that certainly makes for bad governance and quite possibly bad science, too."

Pete Shanks is the author of Human Genetic Engineering: A Guide for Activists, Skeptics and the Very Perplexed, to be published by Nation Books in June.
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We welcome comments on CIRM or the failings of this blog. They will be published. Please send them to djensen@californiastemcellreport.blogspot.com.

Need Work?

Hiring is on the rise on the stem cell front.

Now that California's new stem cell agency has an interim president, he is expected to begin quickly filling a variety of positions. Not that there are a lot of jobs open, something in the neighborhood of 40. They range from general counsel to director of governmental relations.

CIRM has not yet posted the openings on the Web but one would expect to see the listings in the not-too-distant future. Job application forms are available
here.

The Center for Genetics and Society, which is monitoring CIRM, is also looking for new people, including a
director of communications, somebody with considerable experience and a track record. The nonprofit is also looking for a director of administration.

Friday, March 04, 2005

Fiber Optics and 300 Square Foot Offices

Imagine California's stem cell agency a year from now. What is its staff going to look like, its management? What sort of offices might they be working in?

Some indication can be had from documents linked to the RFP for the permanent headquarters. They show that CIRM plans to have 10 top executives with the chairman and president occupying 300 square foot offices.

The agency also wants its new permanent headquarters to contain two conference rooms (750 square feet each) that could accommodate up to 50 persons and four "quiet" rooms for small meetings (two at 150 square feet and two at 250 square feet). Plans call for an employee lunch room (250 square feet) with a dishwasher, full size refrigerator, stove, dishwasher and microwave oven.

The following executives of the agency are listed: chairman, president, vice chairman, deputy chairman, chief legal officer, chief administrative officer, chief scientific officer, chief communications officer, director of government relations and program director. The president and chairman are slated to work in 300 square foot offices. All the rest have 200 square foot rooms.

The plan calls for 37 scientific, medical, technical and administrative staff with 150 square foot offices. Administrative assistants are provided specifically for the president and chairman and one other AA is allocated generally. They are scheduled for 100 square foot open work areas. Out of the 37 staff, presumably at least eight or more would serve as secretaries or assistants to the top executives.

The offices will be well wired with fiber optic cable and a minimum of two voice and two data outlets (more in top executive offices) and cable TV outlets throughout.

The information is contained in documents here and here posted on the Web site of the state Department of General Services.

Wednesday, March 02, 2005

Readers Write

The following is from Terry Feuerborn in California:

"I was very pleased this morning to read that Zach Hall has been appointed head of the new stem cell agency. Prior to his appointment at USC, Zach was Vice Chancellor for Research at UCSF. At that time, I was head of the UC patenting and licensing office. Since patent issues bedevil the research program, I had a lot of interactions with Zach. He was also the campus representative to the system-wide Technology Transfer Advisory Committee, which was set up to monitor the work of my office--among other things.

"Without reservation, I can tell you that Zach's appointment is a very positive development for the stem cell program. Zach is personable, extremely competent, and absolutely straight arrow. I can remember dealing with him on some particularly difficult issues involving the desire of a well-known company to establish a research institute at UCSF. There were many millions of dollars on the table, but the company wanted intellectual property terms that were not acceptable to UC for a variety of reasons. Under very difficult circumstances, Zach supported the principles involved. When a lot of money is being dangled in front of a university, that is a very hard thing to do. I gave him a lot of credit for that.

"Zach should do very well as head of the new agency. I wish him the best."

We welcome comments on CIRM or the failings of this blog. They will be published. Please send them to djensen@californiastemcellreport.com.

Is $389,000 Too Much for "John the Baptist?"

Zach Hall demonstrated a felicitous quality this week after he was named interim head of the California stem cell agency: The ability to turn a phrase.

"I'm John the Baptist here to prepare the way, get things started," Hall was quoted as saying in newspapers in California.

"I will raid every place I can get to get the best possible people," Hall said.

When a public figure can crystallize issues, it goes a long way to ensure that his point of view is mentioned often and prominently in news stories. Good quotes are nuggets that reporters use to fashion stories. Skillful expression is also an important element of strong leadership and management, which is the task before Hall.

Little doubt exists that the stem cell agency has been hard pressed since its first meeting. Hall should boost the agency along, providing more guidance and hiring much needed staffers.

Hall's appointment dominated the news coverage of the agency's meeting on Tuesday. However, Carl Hall (no relation to Zach)of the San Francisco Chronicle focused his story on what appears to be the board's apparent failure to make research grants by May, its own self-imposed deadline.

Coverage of the Halpern-Lee petition, with its concerns about conflict of interest, openness and salaries, shared attention with the presidential appointment. That was to be expected, given the way news coverage works. Hall's salary, $389,000, provided a fresh peg on which to hang some discussion of the petition's concerns about salaries, which it contends are too high. Significantly reporter Paul Elias of The Associated Press, whose story was distributed on Web sites around the world, focused on that in his article.

The board did delegate the petition to Robert Klein, CIRM chairman, who should hand it off immediately to the new interim president. Based on the news accounts, Klein seemed to promise public hearings on the general subjects of the petition, but petition supporters said that was not good enough.

Here are the beginnings of the various news stories that appeared this morning with links:

Associated Press (reporter Elias):
"Even before neuroscientist Zach Hall was formally given the job Tuesday to run California's $3 billion stem-cell research institute, his salary had come under fire. Charles Halpern, a Berkeley writer who filed a legal petition with the California Institute for Regenerative Medicine protesting some of its activities, complained that Hall's $389,004 annual paycheck to serve as interim president was too lucrative."


Contra Costa Times (reporter Sandy Kleffman): "The group overseeing California's $3 billion stem cell research program should adopt tougher conflict-of-interest laws and open up more of its meetings to public scrutiny, critics said Tuesday. Critics pushed for the changes as the fledgling stem cell group held its third meeting and named Zach Hall, 67, as acting president of the California Institute for Regenerative Medicine."

Los Angeles Times (reporter Megan Garvey): "Zach W. Hall, a University of Southern California neuroscientist and former head of one of the National Institutes of Health, was named Tuesday as interim president of the state's new $3-billion stem cell agency. The 29-member board charged with creating the agency voted unanimously to hire Hall, 67. The board has met three times and still has substantial ground to cover before the new California Institute for Regenerative Medicine awards the first grants for stem cell research, something Chairman Bob Klein has said he would like to do by May."

Sacramento Bee (reporter Laura Mecoy): "The stem cell oversight committee hired an interim president Tuesday at a salary critics said was too high, and it sidestepped a petition seeking salary caps and more open meetings. The panel voted unanimously Tuesday to hire neuroscientist Zach Hall as an interim president of the state's new stem cell agency, the Institute for Regenerative Medicine. It set his salary at $389,004 a year."

San Diego Union-Tribune (reporter Teri Somers):
"Despite years of experience and a reputation as a hard-core scientist, Zach W. Hall stepped into controversy yesterday when he was hired as the interim president of California's fledgling stem cell institute. Several watchdog groups questioned the $389,004 salary Hall will receive for the one-year job, which deal has him taking a demotion to senior scientific adviser once a permanent president is found."


San Francisco Chronicle (reporter Hall): "California's $3 billion stem cell program appears all but guaranteed to miss its own informal deadline of issuing its first research grants by May -- a goal that many had doubted could be met. Robert N. Klein, chairman of the California Institute for Regenerative Medicine, said after a daylong meeting of institute policy-makers Tuesday that he still hopes to get some money out the institute's door before July -- but it won't be in the form of research grants."

The San Jose Mercury News used the AP story.

Tuesday, March 01, 2005

More Openness Effort

Supporters of efforts to create more accountability and openness on the part of the California stem cell agency are marshalling their efforts at today's Oversight Committee meeting.

The coalition now consists of the California Nurses Association, CalPIRG, Redefining Progress, Californians Aware, Center for Genetics and Society, the Pro-Choice Alliance for Responsible Research and the Greenlining Institute. The group notified the media that spokespersons will be available both during and after the CIRM meeting.

One measure of the success of the coalition efforts today will be coverage in the media. We will examine that tomorrow.

See the latest press release from the group
here.

High Risk or Low Risk

Robert Klein can make a serious mistake today.

Right now, the chairman of the California stem cell agency seems bent on a course that not only will damage his own credibility but that of the agency that is so important to the people of California and the world. He seems to want to handle privately a legal petition for more accountability and openness.

He can continue on that course or he can support public hearings into the issues that have been raised by legitimate groups and individuals, including the former chancellor of UC San Francisco.

It is a low risk, high reward proposition to hold hearings. They certainly will not impede the progress of the agency, which is exercising some deliberation in the matters at issue. Hearing the voices of all concerned brings everybody into the tent. It ameloriates criticism that concerns have not been heard. It will also provide valuable information that can help draw realistic standards for openness and accountability.

On the other hand, it is a high risk, low reward proposition to take the matters behind closed doors. Such an effort will not stop the critics. Indeed, it gives them more ammunition. Already their assaults are resonating around the world, given our Internet age.

Klein is a well-to-do man with active and substantial business interests aside from his work on Prop. 71 and the agency it created. He deserves great credit for his public service, which has undoubtedly drawn him away from his own enterprises. He was not compelled to serve on the CIRM oversight committee, a task he may come to regret assuming. Many other persons in his position have shied away from public service for a host of reasons.

Klein must be rankled, at least from time to time, by the allegations of conflicts-of-interest and impropriety. Any of us would be in his position. He is also legitimately suspicious that some of the critics simply want to strangle CIRM.

But if they do, the best strategy is to let them display their most heartfelt desires in public in a venue where strong, contrary voices will also be heard.

On today's agenda at the meeting of the Oversight Committee, which he chairs, Klein has placed a resolution to allow him to handle personally the petition for hearings into Halpern-Lee petition, which is seeking adoption of certain standards on conflict of interest, open meetings, hiring and compensation.

It is not entirely clear what Klein would do with that delegation of authority. But it is clear that he wants to sidestep the full board.

Klein repeatedly has voiced his support for the highest and best standards for CIRM on accountability, openness and conflicts of interest. Talk is one thing. Action is another. Alta Charo, the noted bio-ethicist and lawyer, is addressing today's CIRM meeting on matters not related to the Halpern-Lee petition. But she is fond of quoting
Jane Addams (1860 - 1935), the founder of the social work movement: "Action indeed is the sole medium of expression for ethics."

Monday, February 28, 2005

Questions for the Landlord

The RFP for the permanent headquarters of the California stem cell agency admirably attempts to avoid any conflicts of interest with future landlords, but at the same time leaves a substantial ambiguity gap.

According to a CIRM press release, one of the requirements of a lease is a "letter signed certifying that the owner does not have and will not have in the future any ownership interest in any firms or agencies competing for grants to be awarded by the Institute."


The question is: What is ownership? Some folks say owning stock in a company is ownership. However, if the amount is only worth, let's say $10,000, is that ownership? What if it is $1 million? That may be only a fraction of one percent of the value of a company. But it could promise substantial gains if the stock rises.

What about ownership by spouses or minor children? What if the property is owned by a partnership, say 10 persons? Are all 10 required to meet the no-ownership ban?

It is impossible to write rules that cover every possibility, but this one needs a little clarification.

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We welcome comments on CIRM or the failings of this blog. They will be published. Please send them to djensen@californiastemcellreport.com.

What is an Audit?

State Controller Steve Westly is recommending that California's stem cell agency clarify auditing procedures for both the institute and grantees.

His recommendation is contained in a 20-page
review of fiscal standards prepared for distribution to the oversight committee at its meeting tomorrow. The review examined procedures at the NIH, the National Science Foundation and the relatively new and small Stem Cell Research Foundation.

Westly notes that despite longstanding standards at the NIH and NSF, both agencies “still periodically encounter problems that raise questions over the use of grant funds by some of the grantees.” He suggests that CIRM use the agencies' standards as a starting point.

Westly's report says CIRM should “clarify audit requirements for (both) the institute and its grantees.”

“The initiative specifies that the institute shall annually commission an independent financial audit of its activities from a certified public accounting firm. However, what constitutes a financial audit could be interpreted differently, from a very limited-scope financial statement audit to a comprehensive financial and compliance audit. In addition, given that the initiative specifies that the Institute shall commission the audit 'of its activities,' it is unclear as to whether the audit would include the activities of the grantees, which, in our opinion, pose a higher risk,” the report says.

“Therefore, if the financial audit does not include the activities of the grantees, the institute should make arrangements for such activities to be audited. One option would be to adopt the federal single audit requirement by having those grantees receiving grant funds in excess of a certain amount arrange for an independent audit. Another option would be to create an audit function within the Institute to perform grant audits. The institute could also directly contract with other audit organizations for such audits.”

What is an Audit?

State Controller Steve Westly is recommending that California's stem cell agency clarify auditing procedures for both the institute and grantees.

His recommendation is contained in a 20-page review of fiscal standards prepared for distribution to the oversight committee at its meeting tomorrow. The review examined procedures at the NIH, the National Science Foundation and the relatively new and small Stem Cell Research Foundation.

Westly notes that despite longstanding standards at the NIH and NSF, both agencies “still periodically encounter problems that raise questions over the use of grant funds by some of the grantees.” He suggests that CIRM use the agencies' standards as a starting point.

Westly's report says CIRM should “clarify audit requirements for (both) the institute and its grantees.”

“The initiative specifies that the institute shall annually commission an independent financial audit of its activities from a certified public accounting firm. However, what constitutes a financial audit could be interpreted differently, from a very limited-scope financial statement audit to a comprehensive financial and compliance audit. In addition, given that the initiative specifies that the Institute shall commission the audit 'of its activities,' it is unclear as to whether the audit would include the activities of the grantees, which, in our opinion, pose a higher risk,” the report says.

“Therefore, if the financial audit does not include the activities of the grantees, the institute should make arrangements for such activities to be audited. One option would be to adopt the federal single audit requirement by having those grantees receiving grant funds in excess of a certain amount arrange for an independent audit. Another option would be to create an audit function within the Institute to perform grant audits. The institute could also directly contract with other audit organizations for such audits.”

Sunday, February 27, 2005

Ethics: From Compensation to Informed Consent

Bio-ethicist Alta Charo will be speaking this week to the California stem cell agency, and the topic will not be "Star Trek," although she is fond enough of the program to mention it on her web site.

Going where no University of Wisconsin law professor has gone before (which is in front of CIRM), Charo expects to discuss possible creation of a stem cell bank by the agency, among other matters. In remarks prepared to be distributed to Oversight Committee members, she said:

“Forming a physical or virtual stem cell bank could be of great value to the community of researchers in California (and indeed, the nation and the world). Facilitating the task of documenting the ethical standards under which lines were derived will help collaborators to work more efficiently, given the variations in national and international research rules in this field. In addition, a cell bank could set standards for the quality of the characterizations and the accompanying medical information associated with the lines.”


Charo's main thrust, in her prepared material, is to raise questions that should be answered as CIRM begins its funding of research. The areas she touched on include human subject protection, informed consent, patient privacy, compensation bans and possible establishment of an additional committee.

“While most institutions have the committees required by federal law for currently mandated reviews (including IRBs for human subjects protections; Privacy Boards for HIPAA protections; IBCs for recombinant DNA research; IACUCs for animal research) few have any committee specially created to monitor and coordinate compliance with these mandates by hES cell researchers,” she wrote. “Nor do many have a special committee to register the level of activity at the institution, to offer investigator training in stem cell research ethics, or to serve as a venue for discussion, review or even approval of potentially problematic forms of the research. A key question, then, is whether CIRM wishes to encourage or require institutions to create such committees, or whether it plans to have CIRM provide one centrally for all CIRM-funded research. In the alternative, this question could be left entirely to the discretion of individual institutions, who could set up such committees, designate existing committees to expand their functions to incorporate some of these tasks, or simply do without such added oversight entirely.”

Charo is Elizabeth S. Wilson - Bascom Professor of Law and Bioethics at the University of Wisconsin at Madison, where she is on the faculty of the Law School and the Medical School's Department of Medical History and Bioethics.

Her web site shows a long and distinguished career and demonstrates a certain lightness. On it, she reports that she is fond of Star Trek, poker, roller coasters, old movies and salsa music and includes links to appropriate sites in those areas.

The Chairman on Criticism

Robert Klein, chairman of the California stem cell agency, gave an interview to Marisa Lagos of the San Francisco Examiner. It was printed in a question-and-answer format. He was asked about the criticism that his agency is facing. Here is his reponse:

“Ninety percent of the criticisms are from people who opposed Prop. 71. Now, there is 10 percent of the criticisms that are very healthy viewpoints. And even with those people who oppose Prop. 71, when we go through nine months of public hearings for permanent standards, we will try and address their concerns to make sure they understand all the different regulations that will protect individuals. ... What the public doesn't understand is there's layer after layer of protection. There's federal law, there's state law, there's hospital regulations ... and institutional review board standards. ... In addition, the National Academy of Sciences on approximately April 1, [plans] to put out model standards for the nation, that we would hope to look at and adopt with some enhancements, to really create a very high-level model for the whole country to follow in stem cell research standards.”

Friday, February 25, 2005

Restrictions Eased in HQ RFP

Contra Costa Times readers may have been the only ones in the state to receive the latest news this morning on plans for the permanent headquarters of the California stem cell agency.

Reporter Sandy Kleffman said Daly City, San Diego and Sacramento were among cities “monitoring” the committee meeting on the specifications for the headquarters, which are scheduled to be issued formally on Feb. 28 with a decision by May.

She also wrote:

“As they debated what to include in their list of preferences, committee members sought to avoid the perception that they had pre-selected a site by making requirements too restrictive.

“The initial draft of documents said preference would be given to locations within 45 minutes of four or more leading universities or research hospitals. It also said weight would be given to sites with a nearby pool of at least 25,000 biomedical professionals, as long as the majority of them were not engaged in the production of medical devices.

“But some people complained that this left too many cities out of the running. So committee members decided to simply give preference to cities near major universities and a biomedical talent pool, without specifying numbers.

“Preference will also be given to cities that can provide space for major stem cell conferences and that have ready access to Sacramento by plane, train or car. Institute leaders said their staff members will communicate frequently with state officials and they want to minimize travel time.”

The
draft RFP also contained a provision that the HQ should be within two hours of the state Capitol. A technical reading of that would bar San Diego, given that it takes more than two hours from the time you enter the San Diego airport to arrive in Sacramento because of the need to clear security. It is not known whether that provision remains in the RFP.

Permanent CIRM CEO in June?

The proposed timetable for selecting a permanent president for the California stem cell agency calls for his or her appointment at the beginning of June. The schedule dovetails with the selection of a permanent headquarters. Obviously any permanent president would be quite interested in the location of the new work site.

The selection process is up for review and approval on Feb. 28 by a CIRM committee
. The agenda is here, along with the presidential criteria.

Thursday, February 24, 2005

Working Groups Akin to Legislative Committees

The governmental accountability group, Californians Aware, is bolstering efforts to maintain the openness of the working groups of the California stem cell agency.

The group, based in Sacramento, said that the stem cell groups are akin to committees in the state Legislature. If they operate in private, there would be virtually no way for the public or interested parties to make their views known.

Terry Francke, general counsel for the group, said in a letter to the Oversight Committee of the agency:


"Put simply, just as a Legislature without open committees is unthinkable, an ICOC relying on secret Working Groups won’t work in a manner people can trust. California (to say nothing of the rest of the nation and world, who have a substantial interest in what the Institute does) has no shortage of highly seasoned experts and advocates on the scientific, medical, legal, ethical and financial standards whose development and policing are assigned to the Working Groups in the first instance. To give these sources of experience a chance to comment on these standards only at the last minute before the ICOC, and in ignorance of what issues and options had been deliberated, modified, avoided or discarded in the process would be folly, and an insult to tradition."

Francke also noted that it is necessary to observe committee proceedings if economic disclosure laws are to have real meaning. "Knowing what wealth considerations might influence a lawmaker without being able to detect that influence is no better than being able to detect interest biases but not knowing what the interests are," he said.

Francke's letter did not argue that functions of the committees such as peer review of grant recipients and detailed initial discussions of individual grant proposals be conducted in public sessions. He said that California law provides for closed sessions for such matters when they come before state and local legislative bodies.

The Californians Aware letter was written in support of some of the objectives of the Halpern-Lee petition, which seeks to compel the Oversight Committee to hold hearings on rules for open meetings, conflicts of interest and other matters.

The Oversight Committee next week is scheduled to consider a move to delegate the handling of the petition to its chairman, Robert Klein.

Whittling away at Good Will

The MIT TechnologyReview.com picked up The Associated Press story on the legal moves by a couple of conservative groups to shutter the California stem cell agency. Nothing unusual about that, but it carried a side note from an editor on the web site.

"The move to fund stem cell research in California has become a political hornet's nest for the biggest blue state on the map," said Brad King.
"The group has done little to endear itself to the public either, with a series of gaffe's out of the gate that may have undermined its credibility. There are 124 media outlets following this lawsuit story, and a score of other small stories about the group -- very few detailing actual science. Most are stories about external groups fighting with the stem cell board."

Once again we see the impact of a story that has national distribution, in this case Paul Elias' piece. King overstates the matter somewhat. The 124 outlets are not "following" the story. They are receiving and distributing it by automated feeds. He also overstates the impact on the public. This is still a low profile issue with your average Nicolaus and Nikkie. Nonetheless, the distribution of the AP story is vast and does not well serve the stem cell agency. Public good will is being whittled away.

More Legislative Pressure on CIRM

The California stem cell agency is facing increasing pressure from a key California state senator on the issues of accountability, conflicts of interest and openness.

Sen. Deborah Ortiz, chairwoman of a special Senate subcommittee on stem cell matters, has beefed up her oversight legislation and announced a broad-based agenda for a hearing March 9 into CIRM.

Ortiz, a Sacramento Democrat, is no enemy of the stem cell agency. She supported Prop. 71, but has said she wants to ensure that the institute meets its public responsibilities.

Earlier she introduced legislation aimed at doing just that. This week, she amended the bill to strengthen outside review of the agency. In response to an inquiry from the California Stem Cell Report, Hallye Jordan, a spokeswoman for Ortiz, explained the changes in Ortiz' bill, SB18:

"The amendments require the State Auditor to do periodic performance audits on the Prop. 71 ICOC and Institute for Regenerative Medicine. The first audit would be due March 31, 2006. The Auditor would be required to analyze and report to both the Senate and Assembly health committees and the Joint Legislative Audit Committee by December 2006 on the progress of the ICOC and Institute in implementing the audit recommendations. If the results of that review indicate that further work is needed, additional audits would be required to be completed by June, 2007 and June, 2008.

"The ongoing audit concept is similar to that contained in AB 1959 (Chu), a 2004 bill that required periodic audits of state purchasing programs for pharmaceuticals. The argument for the periodic audits is that the size of the program and the fact that it represents a new responsibility for the state merits the ongoing review, coupled with the fact that initial implementation has been rocky.

"The audit reports would be required to investigate the following:

"(1) A review of the strategic policies and plans developed by the Institute and Committee;

"(2) A review of contracts and grants executed by the Institute and Committee;

"(3) A review of the policies and procedures put in place by the Institute and Committee regarding treatment of intellectual property rights associated with research funded or commissioned by the Institute;

"(4) A review of the decision-making procedures and policies adopted by the Institute and Committee, including procedures for open public meetings and disclosure of conflicts of interest on the part of Committee and working group members;

"(5) A review of the medical and ethical policies and standards adopted by the Institute and Committee for research funded or commissioned by the Institute and Committee."

As for the March 9 hearing, Robert Klein, chairman of the CIRM oversight committee, is scheduled to testify for 30 minutes. Also scheduled for 30 minutes is the Greenlining Institute. On tap after that are Terry Francke from Californians Aware, attorney Charles Halpern, representatives from the NIH, Pro-Choice Women’s Alliance and the National Academy of Sciences and State Auditor Elaine Howe, among others.

Rallying on the Right

Expect more from the Christian right, which has started to surface in opposition to the California stem cell agency.

First came the lawsuits earlier this week, asking the California State Supreme Court to extinguish the agency, although it was approved by 59 percent of California voters. Then came the press release on the Christian Communications Network touting the lawsuits.

It will be only a matter of time until the likes of Rush Limbaugh will seize on the issue. The right is very agile on the Web and will rally forces there as well.
In some ways, it is surprising that it has taken so long.

Wednesday, February 23, 2005

Illegal and Unconstitutional?

A trio of politically conservative groups is asking the California Supreme Court to put the California stem cell agency out of business.

The efforts are being made by Californians for Public Accountability and Ethical Science, People's Advocate and the National Tax Limitation Foundation.

The Associated Press
story by Paul Elias, which was distributed nationally, says that People's Advocate and the National Tax Limitation Foundation questioned the creation of CIRM because it's not governed exclusively by state government and because the committee that controls the money isn't publicly elected.

The accountability group contends voters did not have the power to create the agency.

That group also alleges that loopholes exist in the Prop. 71 that would permit the funding of " 'test tube babies,' or even adult human beings, for body parts, companionship or a permanent worker class of subhuman beings (a la, Aldous Huxley's Brave New World)” despite its ban on human reproductive cloning.

The fanciful charge was not reported in the accounts we saw, but is certain to be circulated widely in anti-stem cell circles, regardless of whether it is well-founded.

Julie Buckner, a spokeswoman for CIRM, says the complaints about the legality of Prop. 71 are "strikingly similar" to a lawsuit the tobacco industry filed and lost after the 1998 approval of Proposition 10. Proposition 10 authorized a 50-cent increase in the cigarette tax to pay for smoking prevention and early childhood education programs.

David Llewellyn, a Citrus Heights attorney, prepared the filing on behalf of the accountability group and Joni Eareckson Tada, who is identified as an advocate for the rights of the disabled.

“The people cannot legislate away their inalienable right to be governed only by state officials who have absolute, uncompromised loyalty to the public interest,” the petition for a writ of mandate argues.

Llewellyn contends that Prop. 71 is a “a qualitative revision of the state Constitution, which cannot lawfully be accomplished through the initiative process.”

Stories were also written by Laura Mecoy in
The Sacramento Bee and Teri Somers in the San Diego Union Tribune.

Correction on Bad Links

We had a bad link on the excellent LA Times stories on Sunday dealing with shady efforts at peddling stem cells. Here are the correct links:
"A desperate injection of stem cells and hope" and "Outside the U.S., businesses run with unproved stem cell therapies."

Monday, February 21, 2005

Hearing the Drumbeat

It seems odd that the California stem cell agency cannot move effectively to temper the criticism that dogs it concerning conflicts of interest and accountability.

The issues have plagued CIRM since December when its first meeting was dominated by charges of impropriety and potential impropriety. Since then, Chairman Robert Klein and other oversight committee members have repeatedly stressed their intention to apply the highest standards to the conduct of the agency.

Yet the issues persist, attracting unfavorable attention in the media nationally as well is in California. The stain is not yet permanent. But the longer it exists, the harder it will be to purge. That would be a serious burden for an infant agency that must appear to be acting with propriety in order to succeed.

The latest flap surfaced last week as the result of a petition filed by Berkeley attorney Charles Halpern and Philip Lee, former chancellor of UC San Francisco. Some of the specifics in the petition are old, some new. The two, working with the Center for Genetics and Society, are seeking a 30-minute hearing before the oversight committee to air their concerns. Unless something changes, they are not likely to achieve that goal, based on the agenda for the March 1 meeting. Klein has an item on it to have the board directly delegate their petition to him.

It may be that some of CIRM’s critics simply want to cripple the agency. Halpern and Lee, however, say in their petition, "We want to see the program launched by Prop. 71 succeed."

They also say, "We stress that our focus on the conflict of interest issue is not intended to impugn the integrity of any members of the ICOC or its leaders. We believe that strict adherence to conflict of interest principles is necessary to maintain public confidence in the objectives and processes of the CIRM, and to assure that there can be no doubt that each decision of the ICOC is made exclusively on its merits."

One can understand that the drumbeat of criticism rankles Klein and others, who feel their integrity has been questioned. But testiness and defensiveness can be put aside. The appearance of brushing off ethical considerations should be avoided if CIRM is fulfill Klein’s own very high expecations.

There are a number of ways to handle issues raised by Halpern and others. One would be to create a special panel of perhaps 10 oversight committee members to hold a daylong hearing (no vote to be taken) into the issues. Ask all witnesses to submit all of their material in advance and mount it on the CIRM web site prior to the meeting. Thus the reading of lengthy statements could be avoided. Instead questions could be asked and answered, both on the part of the public and board members, which is more productive than endless readings.

It would be politic to have half of the committee consist of oversight members who are seen to have the greatest potential conflicts.

Holding such a hearing would help to eliminate allegations that critics have not been heard. It would provide useful input in developing rules on ethics and openness. And it would help the agency move forward more rapidly and successfully on its intended path.

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Comments on the conduct of CIRM or the failings of this blog are welcome and will be published. Please send them to djensen@californiastemcellreport.com.

Mighty Full Plate Next Tuesday

From grants to ethics rules, the Oversight Committee has more than enough to do during its day-long meeting scheduled for Tuesday March 1 at Stanford Univeristy.

One also might suspect that a new interim president could be named at the meeting, which has a personnel session scheduled on the matter, followed immediately by a related item during the public meeting. Of course, that could be just a contingency arrangement should a president be ready to announce.

For those interested in the many millions of dollars in grants that CIRM plans to ladle out this year, the board will consider the proposed framework for the initial grants program, including categories of grants and types of recipients.

Also on tap is a conflict of interest code for oversight committee members and staff. The board is additionally scheduled to be asked to delegate to Chairman Robert Klein the responsibility for dealing with the Halpern-Lee petition on conflicts of interest and salary limits.

For more details on the agenda, click here.

The $200 Million Catbird Seat

Wisconsin could siphon off $200 million in future revenues generated by the California stem cell agency, according to one estimate.

The figure was contained in a story in the Milwaukee Journal written by reporter Kathleen Gallagher. It was the first significant media overview of the potential connections between CIRM and the Wisconsin Alumni Research Foundation, which is known as WARF.

She wrote: "The Wisconsin Alumni Research Foundation, or WARF, has two basic patents that broadly cover the preparation of embryonic stem cells, the basic material from which virtually all organs, cells and other body tissues are formed.
If therapies are developed from the research, WARF could be due royalty payments.

" ‘You can allocate $3 billion for research, but you can't spend your way past the basic patents that are in the field,’ said Peter Balbus, managing director at Pragmaxis LLC. The Glen Ellyn, Ill., company helps commercialize technology. ‘I think WARF is really in the catbird's seat.’ "

Balbus gave the preliminary estimate of $200 million going to WARF if the stem cell agency were to generate $4 billion annually in stem cell revenues, a figure cited by Prop. 71 backers.

Gallagher's story is definitely worth a look.

Preying on Desperation

Reporter Alan Zarembo of the Los Angeles Times has produced two excellent stories on the desperation that has fueled the growth of firms peddling unproven stem cell therapy.

One article chronicles the tragic last months of an ALS patient and his relationship with a firm called Biomark, which still has a site on the Web. The other piece begins, "At the junction of desperation and the fantasies of science is a business opportunity. Stem cell clinics offering unproven therapies for a range of diseases have become a multimillion-dollar industry, operating in Mexico, Ukraine, Barbados, China and elsewhere."

Corrective Measures

We all make mistakes.

With that in mind, we want all of the avid and not-so-avid readers of the California Stem Cell Report to know that it is our policy to correct mistakes as quickly and completely as possible.

Nothing is to be gained by making misstatements. Failing to correct them is even a greater disservice to readers. But stuff happens, as they say, particularly in the world of blogging where writers work without editors. So if you see something that is incorrect on this site, please send a note to djensen@californiastemcellreport.com. Our appreciation will know no bounds.

Friday, February 18, 2005

Bee and Chron alone?

The Sacramento Bee and the San Francisco Chronicle may be the only major California newspapers to have written their own stories on the latest move to compel the California stem cell agency to deal more directly with accountability and conflict-of-interest allegations.

Carl Hall
wrote in the Chronicle: “A decorated veteran of the country's public health battles -- dating back to the founding of the Medicare system -- is taking aim at the California stem cell program.

“Dr. Philip R. Lee, a consulting professor at Stanford University and former UCSF chancellor who helped craft national health policies for the Johnson and Clinton administrations, signed onto a legal petition to protest some of the early activities of the California Institute for Regenerative Medicine.”

Laura Mecoy of The Bee
said, “Using a new tactic, critics of the state's stem cell program have filed a petition seeking more open meetings, salary caps and tighter conflict-of-interest rules for paid executives.”

We will have more on this move during the next few days.

Ten Thousand Emerging Realities

Interesting realities often emerge during the start-up of a new enterprise. One of those occasions came this month when John Reed, a member of the oversight committee of the California stem cell agency, noted the potential size of the grant-making effort.

His remarks were made as the oversight group discussed the 15-member grant committee, which he said would be not be able to handle the tens of thousands of grant proposals that are likely to come in annually.

That raises the possibility of creation of some sort of adjunct bureaucracy to assist with the burden, given that even a mere 10,000 proposals amount to roughly 38 for every working day of the year. All would have to be responded to, considered more or less seriously and preserved securely for some time and then presumably destroyed, if not archived. That's just the basics.

Given that the stem cell agency staff is limited to 50 employees, not including members of committees, it seems likely that additional help may be needed for processing, not to mention “a large cadre of expertise” for evaluation. Reed's comments also suggest the stem cell agency could look at other programs to learn more about the workload and how it was handled.

Here is what Reed, who is chief executive of the Burnham Institute in La Jolla, had to say on Feb. 3:

“'...(T)hat number of people (15) is not going to be sufficient to cover the full range of proposals and ideas that's going to emerge in the next decade. So I see them as simply a group that can serve as an initial nodal point for review, but they're going to have to involve a large cadre of expertise.

"I have some statistics here....(I)f you look at a couple of the research grant programs of a magnitude only half of what we're going to be spending, they get 20,000 proposals per year for that amount of money. So we're going to be talking about potentially a lot of proposals, and there's no way 15 people are going to review all those.

“So I think we have to bear that in mind, that this is going to be a much broader group of participation in the end than 15 people.'

“Mr. Shestack: 'The proposals are limited by having to originate in California.'

“Dr. Reed: 'To be put in perspective, there's going to be thousands, if not tens of thousands of proposals potentially.'”

Reed's remarks can be found on p. 163 of the Feb. 3 oversight committee meeting transcript.

Overcoming Short-term Thinking

By the time you read this, the “crunch time” situation for San Francisco's bid for the headquarters of the California stem cell agency may have eased.

That's likely because an article in the San Francisco Chronicle will probably now have served the purposes of the persons providing the information. That would be to flush out some free space for the proposed HQ.

Columnists Matier and Ross reported on Wednesday that San Francisco couldn't get its act together on the bid. Nobody was willing to donate 15,000 square feet of space for a sufficient number of years. Outrageous, opined some civic leaders, who said they expected more.


If the Matier-Ross article did not generate more than one offering for space, we would be surprised. The article also had some interesting details about the SF bid, including insights into the short-term thinking of San Francisco businessmen. We can assure you that Angelo Tsakapoulos in Sacramento, who is offering up 10 years of free space, is not plagued with that ailment.

More Meetings

In case you missed them, here are the latest meetings for CIRM committees.

Site Search Committee -- Thursday Feb. 24, 2 p.m., UC San Francisco. Subjects include the RFP for a permanent site location.
Details here.

Presidential Search Subcommittee – Monday Feb. 28, 9 a.m., UC San Francisco. Subjects include the executive search process timeline proposed by Spencer Stuart.
Details here.

A Few “Clicks” for CIRMers

USA Today carried a story on the California stem cell agency that has an interesting quote from Chairman Robert Klein.

Reporter Elizabeth Weise wrote:

"I'm verging on complete mental exhaustion trying to get it right," says Klein, looking as if he hasn't gotten a full night's sleep in weeks. "I'm averaging 10 to 12 phone calls a day that have to get taken care of immediately, and then a few more to make sure the process keeps moving along."

Klein has a mammoth task before him. It is virtually unprecedented in state history: the almost overnight creation of a new multi-billion dollar state agency exploring the frontiers of science, medicine and theology. Daunting for anyone.

Some folks get a little impatient with the process and progress, partly because of the high expectations that Klein himself has created. But we should remember and appreciate the human aspect of this endeavor. A bunch of folks are working madly to meet the needs of the agency and the people of California. They will never be able to make everybody happy. They are also bound to feel unappreciated as well from time to time. And that includes Mr. Klein.

In the sailing world, we have regular “nets,” times when scores of people gather via ham or VHF radio each day to exchange information. Sometimes people are recognized for their efforts by listeners who all click their microphones at the same time. So here are a few clicks for the CIRMers, including Robert Klein.

Thursday, February 17, 2005

Web-casting for CIRM Proceedings?

The California stem cell agency is considering Web-casting the meetings of its oversight committee to make the operations of the group more accessible to the public and media.

The topic was brought up by Jeff Sheehy, of UC San Francisco and a member of the oversight committee, at the group's February meeting. He said that many members of the public and the media cannot attend the committee meetings for a variety of reasons.

Committee Chairman Robert Klein indicated he would ask an information technology consultant to look into Web-casting as part of a broader review of technology issues.

This is a step in the right direction, but nothing stands in the way of doing right now. It shouldn't take more than a week to set it up for the March meeting of the committee. Any number of firms could handle a one-time shot, and it would provide useful information for evaluating longterm procedures.

Given the nature of the agency, a wise firm would offer to post the proceedings without charge.

The affairs of the California Institute of Regenerative Medicine are of global interest, not only at academic institutions but at private companies and government agencies. Web-casting would help provide the details that are of critical to scientists and policy makers.

Making the proceedings available live on the Web additionally would do much to fulfill the committee's pledges of openness. It would make the stem cell agency accessible to those bright, young scientists it wants to encourage and attract to California.

And it would help counter the negative images now flitting across the country as a result of The Washington Post's page one piece on Sunday (see item on this blog on Feb. 14). Doing that sooner rather than later would seem to be in the stem cell agency's best interests.

Sheehy's very brief comments begin on page 214 of the transcript of the meeting.

Tuesday, February 15, 2005

Correction

On Feb. 13, we wrote incorrectly that a document having to do with grant proposals was no longer available on the CIRM web site. That item is available on the web site but was obscured during a web redesign, and we could not find it. Here is one link to it and here is another that was produced by using the search engine on the site.

HQ RFP by End of Month

The final RFP for the permanent headquarters of the California stem cell agency is expected to be issued by the end of the month. Fiona Hutton, a spokeswoman for the California Institute for Regenerative Medicine, says a press release will be issued when the proposal is ready.

The site search committee has scheduled a meeting to consider the matter on Feb. 24 at 2 p.m. at UC San Francisco. The agenda is here.


Meanwhile, California newsies are busy writing more about the subject and the lobbying efforts that are underway. Most of the stories are in the weekly business newspapers around the state, which specialize in development and leasing news.

Daniel Levine of the San Francisco Business Times
reported that AKT Development in Sacramento plans to offer 10 years free rent with views of the Sacramento River and the Capitol. He also noted that Wareham Development, CIRM's interim landlord in Emeryville, is definitely going to bid for the permanent site. Wareham touts its connection to Chiron, which was co-founded by Ed Poenhoet, vice chairman of the CIRM oversight committee.(See previous items in this blog on Feb. 6 and Feb. 8)

Katherine Conrad of the East Bay Business Times has perhaps the most fulsome
account of Wareham and its approach.

The HQ has even entered the mayor's race in the city of Los Angeles with the incumbent
offering free space downtown.

Jim Wunderman, president and CEO of the Bay Area Council, and Sean Randolph, president and CEO of the Bay Area Economic Forum, plumped for a Bay Area location for the site in an
op-ed piece in the Silicon Valley Business Journal.

Hearing Changed to March 9

The legislative hearing on the California stem cell agency has been changed from March 2 to March 9 at 1:30 p.m. in room 4203 of the Capitol. See item Feb. 7 on this blog for more details.

Monday, February 14, 2005

Bedtime Reading Posted at CIRM

For those of you who have trouble getting to sleep, the California stem cell agency has posted its first cure.

Go to the site and download the 218 page transcript of its February oversight committee meeting. If that isn't enough, try 266 pages from January. For the capper, dig into 99 pages from the accountability working group meeting.

But seriously, this an excellent step in the right direction in keeping the agency open to interested parties. It also serves the agency well. More information on the Web means fewer direct calls to harried staffers and demonstrates its commitment to openness.

Good work, CIRMers.

Whither Melissa?

Melissa Carpenter of Canada's Robart Research Institute may have taken herself out of the running for the post of interim head of California's stem cell agency. Then again she may be right at the top of the list.

The London Free Press is reporting, in an article by John Miner, that she is leaving the institute to work for an unnamed biotech firm in San Diego to research the use of stem cells in the treatment of diabetes.

While she may be eager to return to California and start work in her new position, it certainly would not hurt her or her new firm for the good doctor to take a brief leave before actually reporting in San Diego. Spending six months setting up CIRM would provide invaluable experience and contacts for future endeavors.

Sunday, February 13, 2005

The Washington Post Strikes

Reporter Ariana Eunjung Cha of the Washington Post weighed in on Sunday with a piece on California's stem cell agency that is likely to help shape the national view of the fledgling insitute.

And that is not good news for the agency.

The Page One headline said “Struggling Science Experiment.” The third paragraph of the article said:

“The initiative has been tainted by accusations that those who pushed hardest for the money stand to benefit from it the most. Advocates question the pell-mell pace organizers have set to get the program up and running; they worry that in their haste, program leaders are taking too many shortcuts, leaving the initiative vulnerable to being taken advantage of by private profiteers and unscrupulous scientists.”

The piece contained little that has not already been reported. But it reaches an important audience of opinion and policy makers. It will also likely set the tone for other national coverage of the agency as other media read the piece.

About $90 million in First Round Grants

California's stem cell agency is preparing to ladle out something in the neighborhood of $90 million in grants in the first cycle of what some call the stem cell gold rush.

Based on “conceptual blueprints” prepared by CIRM, most of the money –roughly $60 million – will go for grants for “centers of excellence.” Another $20 million or so will aim at creating 'intellectual infrastructure.” Up to $10 million is slated for seed grants.

Barred from consideration during the first cycle of grants are large “individual initiated” proposals as well as proposals from commercial firms and proposals for clinical research. Those apparently will be considered after standards for research, conflict of interest and intellectual property are developed.

The outline of the first cycle of grants is “evolutionary,” according CIRM documents. What that seems to means is that all of this information is subject to change without notice and probably is already out-of-date. The timetable for proposals is not available but CIRM officials have said they want to distribute some cash by May.

In fact, the document on which this article is based is no longer available on the CIRM site. It was removed with no explanation posted on the web site nor was it replaced with more recent information.

That said, here is a summary of the various categories:

Centers of excellence: Annual grants of $5-$7 million each, including costs of leasing. Bidders are expected to be consortium of institutions or a team of scientists at a single institution.

Intellectual infrastructure: Grants aimed at training post-docs, medical students, young faculty “to populate the field of stem cell research with excellent scientists and physicians.”

Seed grants: Individual grants of about $50,000 to $150,000 for new or established scientists so they can “gather preliminary data on a new idea.” These grants are also aimed at “scientists established in a field other than stem cell research who have promising ideas that, subject to documentation, would justify refocusing their efforts in the stem cell research field.”

If you are interested in receiving the full document, which is a one-page PDF file, please email us at
djensen@californiastemcellreport.com.

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Comments on CIRM or the failings of this blog are welcome and will be published. Please send them to djensen@californiastemcellreport.com.

Facilities Meeting on Feb. 22

The search subcommittee of the Scientific and Medical Research Facilities Working Group Sunday scheduled a meeting for Feb. 22 to discuss criteria and processes for selecting members of the full facilities working group.

Also on the agenda is “consideration of cost effectiveness for facilities grants including discussion of prototype development, renovation of existing facilities and specialized facilities.”

The meeting will be at 9 a.m. at UCLA with teleconference locations at UC Davis, Stanford and the Burnham Institute in La Jolla.
The full agenda should be available at the CIRM
website.

Finding a Focus

Stuart Spencer, the San Francisco search firm hired to help fill “one of the highest-profile leadership positions now being advertised in the scientific world,” may have a little trouble focusing on the task.

That's because it is also bidding to become the search firm to find the new CEO at Hewlett-Packard.

To give you some idea of the magnitude of difference, the Wall Street Journal last week had several front page stories (more inside) on the HP vacancy. It had none on the California stem cell agency.

The HP position is also likely to pay something in the range of $5 to $10 million annually. The CIRM position is more like $500,000 or less. Stuart Spencer is being paid $150,000, plus expenses, for its job with the state of California. No word on the size of the HP contract.

Stuart Spencer reports that it has 300 "consultants" who are available to find execs. It also reports that it "conducted nearly 4,000 assignments" last year.

Writer Carl Hall of the San Francisco Chronicle came up with the description of the CIRM chief's position as the “one of the highest profile....”

Just Call Him Scoop

Reporter Carl Hall of the San Francisco Chronicle seems to have beaten his rivals at other California newspapers with a story that Zach W. Hall of the University of Southern California is the leading candidate to become the interim executive of the California stem cell agency.

Hall – the potential big cheese for CIRM, not the writer – is currently the medical research dean at USC. The Chronicle's report describes him as “a veteran neuroscientist, medical-school administrator and biotech entrepreneur.”

Also in the running is cell biologist Melissa Carpenter, a principal investigator at the Robarts Research Institute in London, Ontario.

According to writer Hall, Dean Hall was one four scientific founders and the former chief executive of a Massachusetts company called EnVivo Pharmaceuticals. It was created in 2001 to develop new treatments for diseases of the nervous system.

“The company apparently has no projects involving stem cell research,” Hall reported.

The Chronicle also quoted colleagues of the 67-year-old Hall as describing him as a “gifted administrator.”

“Hall was recruited to California from Harvard in 1976 to join the faculty at UCSF, where he was head of neurobiology and chair of the physiology department. From 1994 to 1997, Hall took a leave from UCSF to serve as director of the National Institute of Neurological Disorders and Stroke, a part of the NIH.

“He returned to full-time duty at UCSF and became vice chancellor for research in 1998. Hall helped direct the gargantuan planning effort that went into UCSF's Mission Bay campus, a 43-acre project along San Francisco's southern bay shore. Mission Bay is one of several possible locations around the state for the new stem cell institute's headquarters,” the Chronicle said.

Writer Hall said that the dean is not expected to be selected as the permanent chief of the agency. It was not clear whether there was any relationship between the writer and the dean but unlikely.

Thursday, February 10, 2005

Tough CIRM Application Disappears

California's stem cell agency has dropped its probing and perhaps invasive job application form from its web site. Instead the institute now posts a standard state employment application document.

The disappearance of the application form came after the California Stem Cell Report on Feb. 1 wrote about the nature of the inquiries on the original application. The change on the CIRM web site also occurred after the California Stem Cell Report began to query the appointing authorities, from the governor to UC chancellors, about whether they had asked appointees to the Oversight Committee the same questions posed in the application for CIRM employees.

The original application form vanished from the CIRM web site by Feb. 9, the last time it was checked by the California Stem Cell Report, and was replaced by a plain vanilla form.

In response to an inquiry about the change, Fiona Hutton, a spokeswoman for CIRM, said, “As was discussed at the last ICOC meeting, the initial employment application was taken directly from the Governor's web site. In terms of getting up to speed quickly, the Institute staff utilized the Governor's existing application as a foundation to start from. The application has been edited as you pointed out.”

The Feb. 1 item on this web site about the now retired job application said in part:

“California's stem cell agency wants to know. Can somebody that you associated with impugn your character, even unfairly? That is one of the very personal questions that must be answered by job applicants to the California Institute for Regenerative Medicine.


“Might your income or investments present an “appearance” of a conflict of interest? Yes or no. Have you written a letter-to-the-editor on “any particular controversial issue?” Yes or no. Is there anything in your background that could embarrass us? Yes or no. Please explain is the request if you respond in the affirmative.”

Our conclusion was that these questions should be asked, in one form or another, by CIRM of all applicants, ranging from clerks to president. The reason being is that genuinely big money is at stake. And there is a history of successful temptation in other big money venues.

The questions on the application form, however, raised other questions about whether appointees to the Oversight Committee faced the same interrogation. So we addressed the appropriate appointing powers. But some statewide constitutional officers, including the governor, seem terribly timid about making themselves available to public inquiries via email. The email addresses of some of their press offices, which, in theory, would be the most accessible, are virtually impossible to find. If a reporter is part of the Capitoil press contingent, those email addresses are undoubtedly accessible. But if you are a reporter for the Imperial Valley Press, for example, forget about ever sending an email to the governor's press office. You may never find the address.

An exception was the website and office of the state treasurer, Phil Angelides, whose public spokesman, Dan Newman, responded quickly and professionally. The UC campuses were also generally accessible.

Based on the responses to our query, it appears that none of the appointees to the Oversight Committee have been asked the type of questions that CIRM wanted to ask its potential employees with two possible exceptions, including perhaps the governor.

Here is the question that we posed on Feb. 2 to all the appointing entities: “Were the appointees to the oversight committee asked the questions contained in the application prior to their appointment? (We) plan to publish an item on your response next week. Please send it to us by 3 p.m. PST Wednesday Feb. 9. The other appointing powers for the committee are also being asked the same question.”


Here are the responses by office.

Governor – Did not respond. The application form that Hutton mentioned could not be downloaded at the time of this writing, which may have something to do with our Internet link.

Lt. Gov.-- “The Lieutenant Governor did not ask the questions on that list of prospective CIRM candidates and no one provided him with a list of recommended questions. We took the step of providing each potential candidate with a Form 700 (state economic disclosure form) so they could see just what they would need to declare. We also advised them that they should be prepared to recuse themselves from any votes concerning matters that might pose a potential conflict. Dr. Richard Murphy suggested in the interview that subcommittees that screen grant applications should be staffed by people from other states to minimize conflicts. The Lieutenant Governor liked that idea,” said Stephen Green, a spokesman for Bustamante.

Treasurer – “We had those we were considering fill out our standard State Treasurer's Office appointee application, so, no, we didn't use the application that the CIRM is using,” Dan Newman said. The treasurer's application (sent by email) is close to what CIRM had, which is not unexpected considering the sensitive nature of the billions of dollars of investments handled by the treasuer's office. The questions on the treasurer's form include whether the applicant has been involved in an “appearance” of a conflict of interest, has written letters-to-the-editor on controversial subjects and whether the applicant has anything in his or her background that could reflect negatively on the treasurer and more along those lines. (Send us an email if you would like to us to send you the entire application, which is not available online.)

Controller --.Did not respond.

Senate President Pro Tem John Burton, now out office – Could not be reached.

Assembly Speaker – Did not respond.

UC Chancellors – Lisa Lapin, assistant vice chancellor at UC Davis answered first. Her response then became the response of all the chancellors. (For newsgatherers, that is one of the perils of asking questions with a long lead time for response. Everybody's response is easily coordinated, ducks can be aligned, candidness is lost and so forth. But if they aren't given a long lead time for a response, our public information officers often yip like wounded coyotes.)

Here is the UC answer:

“Because the five ICOC members appointed from the UC medical schools are, by virtue of their UC positions, (public officials under the Political Reform Act, they had already filled out state disclosure forms listing their economic interests (Form 700), even before their appointment to the ICOC. Before announcing our appointments, UC reviewed with each member the interests listed on their form and discussed with them the importance of avoiding conflicts of interest and of recusing themselves from decisions in which they have a personal financial interest, as required by law.

“The CIRM employment application form was just recently posted to CIRM's website. It is not something we had seen prior to the appointment of the University'ss ICC representatives. UC Davis Medical School Dean and Vice Chancellor of our health system, Claire Pomeroy, our appointee, has not subsequently been asked by Institute staff to respond to the questions listed on the CIRM application form.”

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Your comments on CIRM or the failings of this blog are welcome and will be posted. Please send them to djensen@californiastemcellreport.blogspot.com.

Tuesday, February 08, 2005

Reaction to Chiron-Wareham Link Piece

The California Stem Cell Report asked both CIRM and Wareham Development for responses to the item posted earlier this week concerning links that Wareham say its has with Chiron, one of whose founders is vice chairman of the oversight committee.

Here is the comment from Tim Gallen, a spokesman for Wareham:

“Wareham has been one of Chiron’s landlords since the company was founded. So, in the past, Chiron leased research space from Wareham and still does -- along with 27 other research companies in Emeryville, Berkeley and Richmond. But, as 'financial links' go, we both know that a common lease is hardly the kind of relationship I believe Mr. Klein was addressing in his remarks to San Diego journalist, Terri Somers.”

The agency has not replied to our inquiry. However, it posted on its web site either late Monday, Feb. 7, or today, Feb. 8, a
press release dated Feb. 3. The item said:

“The lessor(Wareham) does not have any interest in firms or agencies competing for grants to be awarded by the Institute. The Institute staff worked through the State Department of General Services (“DGS”) and the State Controller’s Office to audit available office space and ultimately select the Horton Street location(in Emeryville).”

CIRM Web Site Developments

CIRM's web site is changing. The information is about the same as two days ago, but it does have a press release dated Feb. 3 that was not there on the afternoon of Feb. 7.

The press release contains information that was widely reported in the media on Feb. 4 although with a few more details, depending on what you read.

The changes in the site seem to make it conform to the format and graphics of most California state web sites. It now includes a mug shot of Arnold and a link to his page, for example.

The next step, we hope, is to provide background information packets well in advance of meetings as is the practice of most local and state government bodies in California.

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