Monday, December 13, 2010

CIRM Director Prieto Weighs in on Letter From Scientists

Another member of the governing board of the $3 billion California stem cell agency today questioned a letter from 11 leading stem cell scientists supporting the re-election of Robert Klein as chairman.

Francisco Prieto, a Sacramento physician, commented on remarks by David Serrano Sewell, a CIRM board member and San Francisco deputy city attorney, in the “11 Scientists” item earler today. Prieto also said that the chairman of the agency did not need to have substantial scientific experience as proposed by the 11 scientists.

Prieto said,
“I have to agree with David. This decision is a board responsibility, and our concern is what is best for the future of CIRM. These scientists have the right to weigh in as does any other citizen, but I question at least part of their premise: We may indeed need ' substantial scientific and medical experience,' but there is no particular reason that this expertise must be in the person of the chair. I would argue it more appropriately rests with a VP for R&D, a position we have been trying to fill for much too long now. Bob Klein has an impressive fund of scientific and medical knowledge, but it is largely self-taught, and we may decide that our ongoing division of responsibilities at CIRM should change as the agency matures and evolves.”

Top California Official Urges Suspension of CIRM Chair Election

The state's top fiscal officer, who has a special role in connection with the California stem cell agency, this afternoon called for cancellation of this week's election of a new CIRM chair, declaring that the current process is fundamentally flawed.

John Chiang, who heads a Prop. 71-created committee that reviews the financial practices and performances of CIRM, said in letter to the agency's governing board,
“It is clear that the current selection process is fundamentally flawed. The taxpayers who provide the funds for CIRM must be assured that the chair and vice chair are selected in an open, transparent process – not through a backroom deal or by default because a deal has fallen apart.”
CIRM directors are scheduled to meet on Wednesday to consider the choice for a chairman to replace Robert Klein, a Palo Alto real estate investment banker, whose term is expiring. The only other candidate besides Klein is Art Torres, one of two vice chairs at CIRM. However, Torres withdrew from the running last week, clearing the way for Klein to continue to serve.

Chiang's letter referred to the ruckus over Klein's attempt to hand pick his own successor. The move failed following reports of closed-door meetings and conflicts of interest. The flap attracted attention in the international stem cell community, attention that CIRM did not welcome.

Chiang, a Democrat, said he was strongly recommending that the CIRM board suspend the selection of the chair and vice chair and ask that the nominations be withdrawn. Chiang said,
“The first step in a new process should be for the (directors')Governance Subcommittee to have a full, public discussion of the necessary criteria for a new Chair. The first question the Board should examine is the role of the Chair of the ICOC and how it differs from the role of the President. While I understand that Proposition 71 provides for a unique, co-leadership model, it is critical from a good governance perspective that there is a clear delineation of duties and decision-making.

“What makes a governing board effective is long-term transparency and accountability. The ICOC's most important role - to provide independent oversight of CIRM management - is compromised when the ICOC chairman is essentially serving as the CIRM CEO.

“It also is important to keep in mind that the Chair is but one member of the ICOC Governing Board. Good governance must rely on the actions of the whole Board, not a single member. While the current structure may have been necessary as CIRM was in start-up mode, as the Institute moves into the next phase, it is important from a good governance perspective that it be driven by a fully participating oversight board rather than a single individual, regardless of how talented that individual may be.

“The ICOC has a responsibility to the taxpayers of California to conduct its business in an open and transparent manner. The most effective way the ICOC can assure the public that the Chair and Vice Chair selection process was fair and resulted in the best candidates is to restart the process in a transparent manner.”
The committee that Chiang heads is the only state entity that is charged legally with regularly examining the operations at CIRM.
State Controller Calls for Suspension of Stem Cell Agency Election

Bad Link to Letter Fixed

In the "11 Top Scientists" item today, we had a bad link to the letter that they wrote. The link is now fixed. If you want to go straight to the letter, here is the link.

Eleven Top Stem Cell Researchers Back Klein for Re-election

A who's who of California – if not global – stem cell science is lobbying directors of the state's $3 billion stem cell agency to go along with Robert Klein as its chairman despite the disclosure of his now failed, closed-door efforts to hand pick his successor.

The letter may not necessarily have its desired impact. One CIRM board member, David Serrano Sewell, said,
"Honestly, I'm not sure anyone really cares what they think, they should focus on research and finding cures, not dwelling on board matters."
The 11 signatories to the letter include two Nobel Prize winners, one of whom, David Baltimore, is a former member of the governing board of CIRM. All but one of them have tens of millions of dollars at stake in grants from the stem cell agency and are heavily invested in basic research, as opposed to translational efforts to push research into the clinic.

Irv Weissman of Stanford, one of the signers, for example, has $23 million in grants from CIRM. Another, Larry Goldstein of UC San Diego, holds $14 million in grants. Most of the institutions employing the scientists also have representatives on the CIRM board of directors. (For additional information on Goldstein's grant, see here.)

CIRM is currently involved in assessing the future direction of its research. Should it move more strongly towards business and actual use of stem cell therapies on patients, it is likely to mean that basic research will have a smaller share of CIRM's remaining $2 billion.

In the letter, the 11 said,
“In this regard, we stress, that our collective experience with the discovery of new approaches to the treatment of disease is that new solutions to currently intractable problems will come primarily from research that gives rise to new understanding of disease itself. On occasion, significant progress can also come from thoughtful application of existing knowledge, but either on its own is insufficient. Hence, it is crucial for the next ICOC Chair to have a deep understanding of both scientific and medical principles in order to balance short and long-term investment in stem cell research and clinical application.”
The group plumped for the proposal by Klein, a real estate investment banker, that he be replaced with a nationally known scientist. They said,
“We also enthusiastically support Mr. Kleinʼs proposal to find a successor who has substantial scientific and medical experience as well as personal familiarity with the burdens of disease.”
That requirement is not part of the legal qualifications for chair, which do include a familiarity with bond financing, which is the only source of CIRM funding.

The board meets Wednesday afternoon at Stanford to consider action on nominations for its chair. It does not actually have to vote, however. If it does not do so, Klein, whose term is expiring, would automatically continue in office.

One of our readers refreshed us on that last week after we wrote that Klein appears to be a shoo-in for re-election after the only other nominee, vice chairman Art Torres, said he was stepping aside for the good of the agency. Klein has offered to serve for 12 months without salary until the board picks a new chair. His decision to decline a salary (he now earns $150,000 for half-time work) apparently removes a conflict of interest and enables him to participate in board discussions about chair selection that he would be otherwise barred from. However, removal of his salary would require board action, which would seem to be an ongoing conflict for him, whether he wants the salary or not.

There is a remote possibility that another candidate for chair could surface. The state treasurer has not yet made a nomination. The state controller nominated Torres but could withdraw that nomination in favor of someone else. The governor and lieutenant governor have nominated Klein. The board's choice is limited by Prop. 71 to those nominated by the four state officials, but it does not have to accept any.

Friday, December 10, 2010

Torres Withdraws from Contest for CIRM Chair , Klein Now a Shoo-In

Robert Klein today appeared certain to be re-elected as chairman of the $3 billion California stem cell agency after the only opposing candidate, vice chairman Art Torres, dropped out of the race.

Torres disclosed his withdrawal in a statement posted quietly yesterday on the agenda for next week's board meeting, which is scheduled to consider election of a chair. Torres basically said that he is dropping out for the good of the agency. He declared,
“I believe that the board needs more time to process the qualities it needs in a chair as we move forward to the next crucial phase. We also need to recognize the hard work and accomplishments of this board, as validated by the positive review of the External Advisory Panel’s report. We cannot let our collective success be overshadowed by a leadership debate.

“I initially stepped aside when Dr. Alan Bernstein’s candidacy became apparent. The mission and funding the best science have always been my priority. We owe nothing less to patients and the taxpayers of California.”
Torres continued,
“I am taking Bob Klein at his word that he will serve only for a limited transition period. That will give time for our Governance Subcommittee, under the leadership of Sherry Lansing, to determine the qualities we need in our next chair and to report its assessment to the full board for further discussions and deliberations.”
Torres, a former veteran state legislator, also remarked on the flap in the media about Klein's attempt to engineer the selection of his successor. One longtime observer and participant in CIRM affairs, John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., earlier described the Klein's efforts as “sleazy and inappropriate backroom tactics.”  Klein's actions drew international, unfavorable attention on the Internet and even generated an article in the Toronto Globe and Mail concerning what turned out to be Klein's specious claim that the chairman had to be a citizen of the United States.

Asked for a comment on the latest development, Simpson said,
“The entire 'succession' saga is a debacle that reflects poorly on the ICOC (the agency's governing board), but especially on Bob Klein, who tried to create new criteria for the chair's position not specified in Proposition 71, which he apparently cites when it is convenient and flagrantly flouts when it is not. He wanted to hand pick his own successor, but that effort blew up in his face.

“Art Torres is eminently qualified to serve as chair and I am sorry to see him withdraw. Klein is the one who should stand down.”
In his statement to board directors, Torres said,
“As I'm sure is true for many of you, I am saddened by the recent press and blog stories that have compromised our collective hard work, history and mission. Further, these stories embolden our opponents who seek to stop stem cell research on the federal and state level. We must stand together to confront the challenges that lie ahead.”
Technically another challenger to Klein could arise but that is highly unlikely given Torres' statement, which undoubtedly reflects board sentiments as expressed during closed door board meetings last Wednesday.

Torres' reference to future actions by the Governance Subcommittee concerning selection of a new chair could mean that Klein's attempt to lead the process will be shunted aside. Earlier, Klein, a real estate investment banker, indicated that he thought it was necessary to find a nationally respected scientist to replace him. He said he would engage in a major search to find such a candidate. The board, however, has never said that it thought a scientist was necessary to fill the post.

Simpson said today,
“CIRM does not need a $500,000-a year scientist to serve as chairman when it already as a $500,000-a-year president. If this attempt was prompted by the belief the president is not performing adequately as CIRM's chief executive, the solution is simple. You fire the president and hire a new one. You do not spend another $500,000 of taxpayers' money to create a new position of "executive chairman."
Klein has said he will not serve for more than 12 months. He also recently said he would forego his $150,000, halftime salary, a move that allowed him to take part in the closed-door discussions involving selection of a chair. The action removed an economic conflict of interest on his part.

Thursday, December 09, 2010

The Odd Business of Electing a New CIRM Chair, Plus Klein Says No to Salary

CIRM Chairman Robert Klein will not accept a salary if he is re-elected as chair of the $3 billion California stem cell agency.

Klein's new position was disclosed today by James Harrison, outside counsel to the CIRM board, as part of  a response to queries dealing with executive sessions and election of a new chairman. Previously Klein said he would continue with a half-time, $150,000 salary. The top of chair's salary range hits $529,100 annually.

Klein's decision to not take a salary could allow him to take part in board discussions about a new chair that he would otherwise be excluded from on the basis that he has a conflict of interest involving a possible salary from CIRM

We posed several questions to Harrison in the wake of yesterday's two executive sessions by the CIRM board at its meeting in Irvine. However, before we go into Harrison's response, let's first look at some of the conditions that the CIRM board must deal with in electing a chair, all of which are dictated by Prop. 71, a measure written by Klein, Harrison and a handful of others. The measure also contains terms that make it nearly impossible to change even when it is obviously necessary to do so.

The 29-member CIRM board faces an odd situation. It cannot simply vote one of its members into the office of chair, as most boards might do. Under the terms of Prop. 71, four state officials nominate candidates for the job, if the officials so desire. No penalty is provided if they fail to do so. The board chooses between the four, if it so desires. If it does not, the existing chair continues in place, if he so desires. Or he could walk out the door. Or the board could make it clear that it wants the sitting chair to depart, either informally or by taking a vote of no confidence. In such a situation, presumably the statutory vice-chair, Art Torres, would assume responsibilities until the board approves a new chair.

The board has no deadline for action, other than what it self imposes. If it fails to elect a new chairman by Jan. 3, the new governor and the new lieutenant governor could withdraw the old nominations for Klein, which would take him out of the running. That would leave Torres as the only candidate, assuming that the new governor and lieutenant governor do not offer nominees of their own. Other permutations exist, but I hope readers understand that the process is – how should I say it – goofy?

The Little Hoover Commission, the state's good government agency, last year noted that the process is less than salubrious and recommended changes. However, those proposals have yet to gain much traction.

On top of all this are the state's open meeting laws. They are well-intentioned and serve to protect the public against backroom dealings, but they do make it difficult to make decisions on such sensitive and personal matters as selecting a chairman. Especially for such an ungainly and large board as CIRM's, some of whose members do not know each other well. Ordinarily, in a non-government situation, board members could chat informally and work out a choice. But not at CIRM. For example, its directors must exercise great care so that they do not inadvertently engage in a serial meeting. According to the state attorney general, a serial meeting is “a series of communications, each of which involves less than a quorum of the legislative body, but which taken as a whole involves a majority of the body’s members.” Serial meetings can even occur when surrogates (aides, staffers, etc.) are used to carry messages between board members. It almost means that a board member who wants to talk to another director about a matter must consult an attorney to be sure no law is violated by having the conversation. (Here is more on serial meetings.)

CIRM's board clearly skirted the edge of the ban on serial meetings in connection with Klein's recent unsuccessful efforts to engineer the selection of his successor. But to determine whether the edge was crossed would require an examination of all the email and phone records (home and office) of all the board members for a specific period.

But back to Harrison and his responses to the queries involving yesterday's executive sessions, here are the questions we asked Harrison. His verbatim response follows.
“Did the subject of selection of a new chairman come up during today's executive sessions? If so, please lay out the legal justification for private hearings on what is clearly intended to be a public process.
“Were Klein and Torres present for all or part of the executive sessions? Was Klein present during a presentation by Torres? Was Torres present during a presentation by Klein? On what basis were they excluded? Election of public officials usually takes place in public forums which can be attended by the candidates.
“Did the candidates make presentations to the board on behalf of their own candidacies or answer questions from directors concerning their views on CIRM and the chairmanship? 
“Besides today, has the subject of the selection of a new chairman come up in other executive sessions?”
Harrison's response:
“Prop. 71 permits the Board to convene in closed session to consider matters concerning the appointment and employment of CIRM officers and employees. (Health & Saf. Code, sec. 125290.40(d)(3)(D).) As you know,in addition to being officers of CIRM's Governing Board, the Chair and Vice Chair are also defined as "employees." Consistent with the practice it employed for the selection of Vice Chair in 2009 and the procedure adopted by the Board in August 2010, the Board met in closed session to discuss nominees for Chair and Vice Chair. The Board did not, however, take any action. Also consistent with past practice and the procedure adopted by the Board in August, there will be an opportunity for public presentations by the nominees, and the Board will take action in a public session.
“Art and Bob appeared separately before the Board to answer questions regarding their respective candidacies for Chair. To avoid any potential for a conflict of interest, neither was present while the other answered questions regarding his candidacy for Chair.
“The subject of nominees for Chair has not come up in a prior closed session.
“Bob Klein asked me to let you know that he will not accept a salary to underscore that, if elected, he only intends to serve during a transition period.”

More Than You Want to Know About Serial Meetings

Here is what the state Department of Justice has to say about serial meetings involving public agencies in California. The act referred to is the Bagley-Keene Open Meeting Act
“The Act expressly prohibits the use of direct communication, personal intermediaries, or technological devices that are employed by a majority of the members of the state body to develop a collective concurrence as to action to be taken on an item by the members of the state body outside of an open meeting. (§ 11122.5(b).)

“Typically, a serial meeting is a series of communications, each of which involves less than a quorum of the legislative body, but which taken as a whole involves a majority of the body’s members. For example, a chain of communications involving contact from member A to member B who then communicates with member C would constitute a serial meeting in the case of a five-person body. Similarly, when a person acts as the hub of a wheel (member A) and communicates individually with the various spokes (members B and C), a serial meeting has occurred. In addition, a serial meeting occurs when intermediaries for board members have a meeting to discuss issues. For example, when a representative of member A meets with representatives of members B and C to discuss an agenda item, the members have conducted a serial meeting through their representatives acting as intermediaries.
242 Ops.Cal.Atty.Gen. 61 (1963); see also 32 Ops.Cal.Atty.Gen. 240 (1958).

“In the Stockton Newspapers case, the court concluded that a series of individual telephone calls between the agency attorney and the members of the body constituted a meeting.3 In that case, the attorney individually polled the members of the body for their approval on a real estate transaction. The court concluded that even though the meeting was conducted in a serial fashion, it nevertheless was a meeting for the purposes of the Act.

“An executive officer may receive spontaneous input from board members on the agenda or on any other topic. But problems arise if there are systematic communications through which a quorum of the body acquires information or engages in debate, discussion, lobbying, or any other aspect of the deliberative process, either among themselves or between board members and the staff. Although there are no cases directly on point, if an executive officer receives the same question on substantive matters addressed in an upcoming agenda from a quorum of the body, this office recommends that a memorandum addressing these issues be provided to the body and the public so they will receive the same information.

“This office has opined that under the Brown Act (the counterpart to the Bagley-Keene Act which is applicable to local government bodies) that a majority of the board members of a local public agency may not e-mail each other to discuss current topics related to the body’s jurisdiction even if the e-mails are also sent to the secretary and chairperson of the agency, posted on the agency’s Internet website, and made available in printed form at the next public meeting of the board.4

“The prohibition applies only to communications employed by a quorum to develop a collective concurrence concerning action to be taken by the body. Conversations that advance or clarify a member’s understanding of an issue, or facilitate an agreement or compromise among members, or advance the ultimate resolution of an issue, are all examples of communications that contribute to the development of a concurrence as to action to be taken by the body.

“Accordingly, with respect to items that have been placed on an agenda or that are likely to be placed upon an agenda, members of state bodies should avoid serial communications of a substantive nature that involve a quorum of the body. In conclusion, serial meeting issues will arise most commonly in connection with rotating staff briefings, telephone calls or e-mail communications among a quorum of board members. In these situations, part of the deliberative process by which information is received and processed, mulled over and discussed, is occurring without participation of the public. Just remember, serial-meeting provisions basically mean that what the body can not do as a group it can not do through serial communications by a quorum of its members.”

No Real Problem with Canadians as CIRM Chair

A California attorney general's opinion rendered decades ago makes it abundantly clear there was no real legal barrier to a Canadian citizen serving as chairman of the state's $3 billion stem cell agency.

CIRM Chairman Robert Klein announced last week that the candidacy of Alan Bernstein, head of HIV Global Vaccine Enterprise of New York, had to be dropped because of what Klein described as a citizenship problem. Klein's announcement came after a public ruckus erupted over his attempts to maneuver Bernstein into the chair's post.

Klein referred to a California government code section that says a person cannot hold “civil office” in California without being a citizen of the state.

However, the 1978 opinion from the attorney general said,
“This section by its requirement of citizenship for the holding of a civil office is unconstitutional in that it is not narrowly and precisely drawn so as to apply only to offices whose incumbents participate directly in the formulation, execution or review of broad public policies having a substantial impact upon the public. 61 Op.Atty.Gen. 528, 12-6-78.”
In California, such attorney general opinions are the litmus test for actions by state agencies, having the force of law for all practical purposes. The attorney general's Web site says,
“The formal legal opinions of the Attorney General have been accorded 'great respect' and 'great weight' by the courts.
As reported in a previous item, Web CIRM's outside counsel, James Harrison, told us,
“We discovered the citizenship issue when Bernstein's name was mentioned as a candidate. Given the litigation CIRM has faced over the years, there was a need to be cautious and there was not sufficient time to obtain closure on this issue before the deadline for nominations. You should know that there is an AG opinion from 1978 declaring that the citizenship requirement is unconstitutional.”
Earlier we raised the question of whether the law in question would apply to CIRM President Alan Trounson, who is an Australian, and who was hired three years ago. Our reading is that it would. However, that is moot given the attorney general's opinion.

Wednesday, December 08, 2010

CIRM Board Meeting Back Online

The Internet audiocast of the CIRM board has resumed with discussion of changes in the biotech loan program.

CIRM Directors Resume Public Meeting

Directors of the California stem cell agency reconvened in public after a lengthy closed-door session during which they were believed to be discussing the election of a person to replace Robert Klein as chairman of the $3 billion enterprise. 

The Internet audiocast of the event was up briefly but has now vanished. 

Trounson on Recommendations of Blue-ribbon Reviewers

CIRM President Alan Trounson was generally pleased today with the report and recommendations of a  blue-ribbon panel that reviewed the $3 billion stem agency's effort.

He made a presentation to the board at its meeting today in Irvine that was a bit truncated in the Internet audiocast. However, you can find a summary of his remarks (Power Point style) here. The bulleted points are his response.

Trounson was principally responsible for the selection of the members of the panel and orchestrated the three-day October review, which was conducted almost entirely behind closed doors.

CIRM Press Release on External Review Report

The California stem cell agency today posted a press release on the report and recommendations  by a blue-ribbon review panel that were discussed today at an Irvine meeting of its board of directors. The release contains quotes from both reviewers and board members. You can find it here.

Stem Cell Agency Board Still in Closed Session

Directors of the $3 billion California stem cell agency are still meeting in closed session following a statement by its Chairman Robert Klein defending his actions in connection with an attempt to hand pick his successor.

The board went to lunch and into an executive session about two hours ago shortly after Klein orally laid out his view of what transpired in connection with the nomination of Alan Bernstein to succeed Klein. Klein did not ask for questions from the board.

We have queried the board's outside attorney, James Harrison of Remcho Johansen and Purcell of San Leandro, Ca., whether the subject of the election of a new chair is part of the executive session discussions.

Prop. 71 does not specifically provide for closed door meetings in the selection of a chair.  About the election process, it simply says,

"A chairperson and vice chairperson who shall be elected by the ICOC members. Within 40 days of the effective date of this act, each constitutional officer shall nominate a candidate for chairperson and another candidate for vice chairperson."
However, the chair and vice chair are CIRM employees by law and are entitled to salaries. Personnel matters may be considered in executive session, under state law. Most actions involving votes of the full board must occur in public.

Klein Addresses CIRM Board on His Succession Moves

Robert Klein, chairman of the California stem cell agency, today commented orally and briefly on his efforts to hand pick his successor at the $3 billion enterprise.

His remarks were a shorter and slightly altered version of the material he posted this morning on the agenda for today's CIRM directors meeting in Irvine.  Klein made one important addition to the posted material. He indicated that the board could not legally have a search committee that would make recommendations to the four state officials who make nominations. Prop. 71, the measure that created CIRM, stipulates that the board may choose from the nominees, although it could also reject them and request new ones.

Klein's surprise statement was the most forthcoming he has been on his unsuccessful effort to engineer the selection of Alan Bernstein as his successor. Bernstein is head of HIV Global Vaccine Enterprises of New York and chair of a panel that reviewed CIRM operations. News reports spoke of closed-door meetings and conflicts of interests involving Klein's attempt and rankled some CIRM board members.

Klein's comments this morning came just before the board's lunch break and a brief invitation from a UC Irvine stem cell researcher, Peter Donovan, to the board to tour the UCI stem cell facility, which CIRM helped finance. Klein did not entertain questions from CIRM directors.

Klein Defends Role in Selection of Successor

CIRM Chairman Robert Klein today posted a statement on the CIRM Web site regarding his attempt to engineer selection of his successor at the $3 billion stem cell agency. Klein's remarks were filed on the agenda for today's meeting of the CIRM board. It was not immediately clear whether he read the statement to the full board because the audiocast of the meeting began late and was interrupted from time to time.

Here is an excerpt:
"I organized a dinner among all of the individuals whose names were under consideration for nomination. I asked for Board counsel to be present to be sure that Bagley-Keene (open meeting law) requirements were observed. The intent was to provide a free exchange of ideas between the candidates and an opportunity for them to get to know one another. Indeed, I intentionally invited an individual whom I knew had a significantly different position than mine, in order to provide him an opportunity to present his views. The mutual respect and understanding of the candidates’ positions is generally considered essential to prepare for a thoughtful Board discussion on similarities, differences and strategic advantages of one possible candidate versus another. It was also intended to lay a foundation for constructive cooperation between those who succeeded and those who did not succeed in the election.

"Ultimately, lacking time to resolve a technical legal issue, the Governor nominated me, but I have made it clear that I only intend to serve until a new Chair can be selected. In my view, the best candidate would be a person who has exceptional scientific and/or clinical expertise and outstanding patient advocacy credentials that testify to his or her ability to assist in reaching the ultimate objective of our principal mission of driving therapies safely and quickly through FDA-approved clinical trials to patients. Certainly, I would include in our primary mission the parallel development of basic science to validate our understanding of chronic disease and the “mechanisms of action” of potential therapies; as therapies proceed through clinical trials, there will be innumerable intellectual challenges to overcome, ranging from basic science through early translational development issues through to clinical trial methodologies. The ideal candidate would have the education and experience to understand this entire continuum of biomedical knowledge.

"I had scheduled a Governance Subcommittee meeting to discuss the value of a scientist-clinician as Chair, but given that Dr. Bernstein was no longer a candidate, that issue was
moot.

"I look forward to a future, robust discussion at the Governance Subcommittee and at the Board of the best criteria for a new Chair."
(Editor's note: Klein later presented a briefer and slightly altered version of the statement orally to the board.)

CIRM Directors Probe New Directions for Stem Cell Agency

Directors of the California stem cell agency have just finished hearing the formal presentation of the report from the blue-ribbon review panel that recommended a strong push towards developing therapies and engaging the biotech industry, which has complained about its treatment by CIRM.

The directors took a short break and are scheduled to reconvene shortly. Some members of the public are expected to present statements.

CIRM directors this morning questioned the panel about engaging industry, improving communications  and proposals by the panel to reach out to find research any place in the world that could lead to therapies. Board members indicated that sort of "proactive" effort could be difficult given that CIRM funding is restricted to California. Review panelists said various kinds of collaborative efforts could be used without running afoul of the funding restrictions.

On relations with the biotechindustry, Alan Bernstein, head of HIV Global Vaccine Enterprise of New York and chairman of the review panel, said the group had "heard a lot of things from industry about things not working." He said,
"CIRM's management has to start talking with industry in a meaningful two-way dialogue."
CIRM Director Leeza Gibbons, a Hollywood entertainment figure and patient advocate, had a suggestion on improving recognition of CIRM among the California public. "We all want and need heroes," she said. Creating emotional connections is the way to win the hearts of the people, she said.

During its three-day review in October, members of the panel had wondered why the stem cell agency attracted so little attention in the mainstream media in California, a problem that relates as much, if not more,  to the nature of the state of the media as it does to CIRM.

Bernstein said greater use of patient advocates was important in communicating with the public, a suggestion that dovetailed into Gibbons' comment.

The panel reiterated its recommendation that the board should focus on strategic matters and clarify the conflicting roles of chairman and president, a longstanding problem created by the language of Prop. 71. 

Scientist George Daley of Harvard, one of the review panel members, said, "CIRM is in unique position" in the world "...because it has a bully pulpit, because it has tremendous influence."
He suggested that CIRM might want to assemble a "rapid strike force" to review outstanding research opportunities in the world to figure out how California can play a role.

Upcoming

We will be bringing you live coverage of today's meeting of the governing board of the California stem cell agency at UC Irvine. We are monitoring the session via the Internet from El Salvador with a cellular connection from a sailboat in the Estero de Jaltepeque. Stories will be filed as warranted. The meeting is scheduled to get underway at 9:30 a.m. PST, but usually begins shortly after the scheduled start-up time. If you would like to listen to the Internet audiocast, directions can be found on the meeting agenda.

The Canadian Citizenship Question – Day Four, an Answer!

The requirement that the chairman of the California stem cell agency be a citizen of California is unconstitutional according to a 1978 opinion by the state attorney general.

That's what James Harrison, outside counsel for CIRM, told the California Stem Cell Report early today. He was responding to an email query yesterday concerning the reason that Alan Bernstein, a Canadian, was scrubbed as CIRM Chairman Robert Klein's favorite candidate to succeed him in the position. Official opinions of the attorney general are widely regarded to have the force of law. The way the attorney general's Web site puts it is,
“The formal legal opinions of the Attorney General have been accorded 'great respect' and 'great weight' by the courts."
Here is what Harrison had to say,
“We discovered the citizenship issue when Bernstein's name was mentioned as a candidate. Given the litigation CIRM has faced over the years, there was a need to be cautious and there was not sufficient time to obtain closure on this issue before the deadline for nominations. You should know that there is an AG opinion from 1978 declaring that the citizenship requirement is unconstitutional.”
As far as we can tell the first public mention of Bernstein's name as a candidate came on Nov. 29 on the California Stem Cell Report. However, his name was being bandied about privately well before that. Late on Dec. 2, Klein released a statement that Bernstein was no longer being considered because of “a technical legal requirement regarding citizenship.”

Klein's statement followed stories in the media (see here, here and here) involving closed-door meetings and concerns about conflicts of interest in connection with his attempts to engineer selection of his successor. The ostensible citizenship condition also led to a well-read story in the Toronto Globe and Mail in which scientists in Canada deplored the requirement.

Harrison's response today about the matter came four days after we asked CIRM's official spokesman to provide the exact legal language concerning what Klein said was a citizenship problem.

We still have questions about whether the citizenship question applies to CIRM President Alan Trounson, an Australian, as well as the actual date when CIRM officials became aware there might be an issue with Bernstein.

Our assessment of the situation? Klein's statement was specious, at best. At worst, it might be called something else. It appears to be a dubious effort to paper over what is serious leadership issue involving Klein and raises significant questions about his credibility.

Tuesday, December 07, 2010

The Canadian Citizenship Question: Day Three

What exactly in California law bars non-citizens from becoming the chair of the $3 billion stem cell agency? Especially since its president is an Australian.

We asked Don Gibbons, CIRM's chief communications officer, about the issue last Friday morning. So far we have not heard back from him despite two additional queries. This morning we tried James Harrison, outside counsel to the board.

Our question to him was more specific and related to a provision that we found in state law (government code section 1020) that says,
“A person is incapable of holding a civil office if at the time of his election or appointment he is not 18 years of age and a citizen of the state.”
So we asked Harrison about that in addition to an opinion by the state attorney general's office concerning application of the section in the case of an appointment of a person to fill an unexpired district attorney's term. That instance involved an elective office. So far we have not found an opinion concerning application of the code to a non-elective position, such as president of the stem cell agency.

Of course, the key is how “civil office” is defined. The government code contained no definition. We searched other sections of California law as well but turned up no definition. However, opinions by the attorney general that related to “civil office” that we uncovered dealt with popularly elected officials.

Another little twist is whether the chair is “elected.” The directors vote on the position, but he is not elected by a vote of citizens.

So what does this all mean? When did CIRM Chairman Robert Klein and Harrison know there was a difficulty? Why was it not disclosed until after the ruckus erupted about Klein's attempt to install a Canadian as his successor?

Perhaps all will be revealed on Day Four of the “Canadian Citizenship Question.”

Monday, December 06, 2010

Read This Item to See What CIRM Has Expunged From Its Web Site

With one day left before Wednesday's meeting of the directors of the California stem cell agency, the public can find much to mull over by reviewing the agenda for the session.

But no one will find anything on three matters that have been expunged from CIRM's Web site. They deal with the less than artful attempt by CIRM Chairman Robert Klein to engineer the selection of his successor.

The items were removed after Alan Bernstein was scrubbed as a candidate following reports of conflicts of interest, inappropriate closed-door meetings and a late-coming disclosure that his Canadian citizenship reportedly disqualified him.

Here are the items that were stripped from CIRM's official agendas for both last Wednesday's meeting of the Governance Subcommittee and the full board session this Wednesday.
“Consideration of budget allocations and structural priorities.

“Consideration of future assignments to and volunteer support by Chair Emeritus.

“Consideration of authorization to compensate Patient Advocate Vice-Chairs of Grants Working Group in excess of cap if service as GWG Vice-Chair and Vice-Chair of any other Working Group requires commitment of more than 26 days per year.”
On the Governnance Subcommittee agenda today you will find only one word – “CANCELED” – in the place of these proposals. No mention is also made on the agenda for Wednesday's full board meeting that the document has been significantly altered and matters removed with no explanation.

Last week, we reported that CIRM had left the public and industry in the dark when it failed to provide any additional information beyond the cryptic listings of the three items, which appeared to involve fairly significant matters.

The board's outside counsel, James Harrison of Remcho Johansen and Purcell of San Leandro, Ca., Harrison, responded at the time, defending its information practices and also indirectly shedding some light on Klein's scheme to select his own successor. Harrison said in an email on Wednesday,
“In the case of the Governance Subcommittee, there are no written materials for two of the items because they are placeholders which will not be addressed at the meeting (because Bagley-Keene requires CIRM to post the agenda ten days in advance of a meeting, we sometimes include items before we know whether consideration of the items will be required in order to preserve the opportunity to consider them).  As to the one item which will be considered (the role of the former chair), the discussion is intended to be conceptual.  If the Subcommittee decides to move forward on this item, written materials will be prepared and distributed well in advance of the Board meeting at which it is considered.”
Our response? From the very first, CIRM should have said on the agenda that the items were placeholders involving selection of a new chairman or involved a conceptual discussion and why. To do otherwise is to withhold from the public important information that the State Constitution says it has a right to see. The upshot is that interested parties are left to ferret out or speculate on reasons behind the proposals, which, quite frankly, is not in CIRM's best interests.

CIRM also compounded the error by expunging the items entirely. It is not the first time that material on CIRM's Web site has been altered without providing any indication to readers that it has been changed. The information that CIRM presents on its Web site constitutes an official government document. When changes are made, there should be a trail that shows the changes. In this case, the items should have been left on both both agendas with a note that the meeting was cancelled or the matters would not be taken up. In essence, stakeholders and interested parties now have to save all versions of CIRM Web documents in order to detect whether changes are being made, significant or otherwise.

As for the items currently listed by CIRM to be considered by its directors on Wednesday, they include the report of the external review panel(see here and here), changes in IP policy, current budget figures and changes in its biotech loan programs.

The Irvine meeting will be audiocast on the Internet. Directions for tuning in can be found on the agenda.

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