Does the Stem Cell Agency Have Enough 'Bandwidth' to Do The Job?

SAN FRANCISCO – A blue-ribbon panel examining California's $3 billion stem cell agency began its second public session this morning with some of its members saying they are impressed by what they have learned so far and with some expressing concern about whether CIRM has enough “bandwidth” to achieve its goals.

Alan Bernstein, chairman of the panel and executive director of the Global HIV Vaccine Enterprise of New York, described the agency as a “very exciting experiment in science,” one that the “world is watching.” Others also said they were impressed by how much CIRM has accomplished during its nearly six-year existence.

But panelists also said it could be difficult for the agency to do all that it is proposing. Richard Klausner, managing partner of The Column Group, a San Francisco venture capital firm, and Igor Gonda, CEO of Aradigm of Hayward, Ca., were among those concerned about CIRM's “bandwidth” problems. Klausner said he was “completely amazed” at what CIRM is trying to accomplish. But both expressed concern about whether CIRM had the necessary “resources” to do all that it proposes

Their comments apparently referred to the size of CIRM's staff, which was limited by Prop. 71 to 50 persons in addition to a 6 percent cap on its administrative budget. The agency has never had 50 employees although CIRM President Alan Trounson earlier this year warned that the quality of work was in danger because of the limit. Since then, the legislature has removed the cap in a new law that will take effect Jan. 1. However, according to CIRM officials, the size of the CIRM staff is not likely to exceed about 54 persons any time soon.

Although recruiting and hiring usually takes months, CIRM also does not seem to be making a running start on its opportunity to hire more staff. The agency has not yet posted significant numbers of new openings on its Web site. One key position, the new vice president for research and development, has been vacant for about 14 months. The post was supposed to represent a major effort to engage industry, which has been less than happy about its meager share of CIRM grants, about 4.5 percent.

The limit on CIRM staff has forced it to rely heavily on outside contractors, whose expenses are the second largest component in its operational budget. This year contractors are expected to cost $2.8 million, up 21 percent from last year.

This morning, the external review panel conducted a three-hour public session and then moved into a closed-door meeting. Today's meeting was consumed by presentations from CIRM Chairman Robert Klein and others. Public comment was called for with about 15 minutes left in the session. No members of the public offered comments, and only perhaps one or two were in attendance. Another one-hour public comment session is scheduled for tomorrow morning at 8:30 a.m.

Klein and others offered an overview of the agency, its history and underlying philosophy. He noted that the use of bond financing (money borrowed by the state) was aimed at assuring long-term financial stability for scientific research. He also said the debt, which will extend over 42 years, will be paid by the beneficiaries of the results of the research. At one point, he noted that borrowing the $3 billion will cost another $3 billion or so in interest.

Scientist George Daley of Harvard, another of member of the external review panel, raised a question about whether efforts such as CIRM are a threat to the “paradigm” of federal funding of research through the NIH.

CIRM Vice Chairman Art Torres said that the results of CIRM research will benefit the entire nation. Klein said the California effort will put pressure on Congress to develop more stable ways of financing scientific research.

Blue-Ribbon Panel Hears Recommendations for More Openness at California Stem Cell Agency

SAN FRANCISCO – Only four members of the public attended the first day of a blue-ribbon review of the operations of the $3 billion California stem cell agency during the brief period permitted for public comment.

The panel shut down its public session after about one hour and moved from the Marriott Hotel in San Francisco to CIRM headquarters to continue the meetings behind closed doors.

The small number of persons at the public comment session was to be expected. The agency made a late decision to permit public comment and then two days ago changed the location. Moreover, even CIRM board meetings rarely attract more than a handful of people. But again, CIRM makes little attempt to actively publicize directors' meetings.

Public comment sessions are also scheduled for tomorrow and Friday morning. The specifics and location can be found here. 

Three of the persons appearing this morning before the panel had type one diabetes and praised the agency for its search for therapies. One, Jessica Ching, is involved in the medical device and marketing field. She urged the panels to ensure that financing and development of commercial products are the primary goals of CIRM's efforts.

The fourth member of the public was yours truly. I read a statement to the panel urging more openness and transparency on the part of the agency and recommended several specific changes. In response, several members of the panel commented about the importance of openness in generating public trust. One later noted that scientists sometimes have difficulty understanding the need for transparency.

Here is the statement.
Statement by California Stem Cell Report to CIRM External Review Panel

Public Still Barred from Sweeping CIRM Review

The California stem cell agency confirmed this morning that the public remains barred from the key sessions of this week's sweeping review of the operations of the $3 billion public enterprise.

In response to a query, Don Gibbons, chief communications officer for CIRM, said,

“The public is only invited to the sessions that are marked as public.”

We raised the question because CIRM removed information this week from its Web site that explicitly said the public was banned. Also removed was information about the location, time and subjects of the closed-door proceedings. The  new announcement, posted just two days ago, additionally said that more time was being allotted for public comment.

The external review of CIRM,  the most comprehensive ever, begins this morning at San Francisco's Marriott Hotel.

We will be providing coverage today of the proceedings that we have access to.

More Time for Public Comment at CIRM Review But Doors Still Closed Otherwise to Public

Making a last minute change, the California stem cell agency has decided to allow more time for public comment during the sweeping review this week of its operations, but still will apparently bar the public from hearing testimony by witnesses.

The first public comment session will come tomorrow morning at 8 a.m. Other public comment sessions will be on Thursday and Friday mornings.

In the announcement posted just yesterday on the CIRM Web site, the agency also changed the location of the public comment sessions from CIRM headquarters to the Marriott Hotel in San Francisco.

The new information on the CIRM Web site removed an earlier agenda that said that the public would be barred from the panel's other sessions. However, this afternoon when we encountered Don Gibbons, CIRM's chief communications officer, at CIRM headquarters, he did not mention any change in policy. But that encounter was before we saw CIRM's new announcement, and we are querying Gibbons again concerning the likelihood of a change.

Also posted on Monday was a 29-page report (dated Oct. 8) by CIRM Chairman Robert Klein that will be presented to the blue-ribbon panel that is conducting the most comprehensive review ever of the $3 billion agency.

Our view on these last minute changes? The notice comes too late for all nearly all interested parties to find the time and make the effort necessary to prepare thoughtful comments. Plus the public still is apparently banned from hearing information that will be critical in determing the future direction of an agency that is spending $6 billion (including interest) of taxpayer funds.

We first wrote about the external review on Sept. 23. At that time, CIRM had not notified the public that the external review would occur nor had it solicited publicly any comments from interested parties, although the review had been planned for many months. Nor was any provision being made for public testimony at the review. CIRM has changed its position somewhat, but the public is still barred from what essentially is its own business.

Parsing Statistics vs. the Reality of Biotech Concerns About CIRM

The California stem cell agency is missing the essential point of complaints from the biotech industry concerning CIRM's record on funding commercial research.

In its response to the biotech concerns, CIRM parsed statistics compiled by BayBio, the biotech industry group in Northern California, but ignored the reason for the private dinner meeting in August between top executives of the $3 billion agency and the area's stem cell firms.

Industry is less than happy with the California Institute of Regenerative Medicine. BayBio and the Orrick law firm did not bring together all those CEOs in August to pat CIRM on the back.

The industry concerns are not new. They have been around for several years. They have been acknowledged more than once by CIRM directors, some of whom have spoken pointedly about the need to funnel more cash to stem cell businesses. It is not just a matter of spreading money around equally. It is a matter of actually creating usable medical products, something that Stanford, the University of California and nonprofits are not going to do.

Director Jeff Sheehy, a patient advocate member of the CIRM board who works at UC San Francisco, said at the August CIRM board meeting,

“From the minute I've been on this agency I've heard...(at)all the industry meetings -- I've heard (that) we've got products waiting for money.”

According to the transcript of the meeting, CIRM Chairman Robert Klein, a real estate investment banker, acknowledged that CIRM does not have a “big supply” of grant reviewers with industry expenence – one of the problems cited by BayBio for the lack of grants to business. Finding them is “difficult,” Klein said.

Director Philip Pizzo, dean of the Stanford School of Medicine, additionally raised a question about CIRM's outreach to business.

“If industry has got things in the pipeline...are there ways that we could seed this to happen in more novel manners?

“Have we had, for example, as part of our strategic planning effort, an off-the-record kind of think tank between industry leaders, academic, venture capitalists in the same room at the same time, not separate -- would you buy into this ...approach -- but really coming together and say if we could create the world differently, how might we think about novel ways of approaching these kinds of both research and translation efforts?”

The question went unanswered at the board meeting. The strategic plan, however, comes up next week at CIRM headquarters in San Francisco when a blue-ribbon panel of external reviewers will conduct a closed-door examination of CIRM and its performance. The meeting's agenda, however, does not mention the stem cell industry's concerns.

Industry executives have been reluctant to go public with their issues, understandably wary of offending a financially powerful organization. Privately, they are more frank. We have heard bitterness and frustration from a number of them.

The industry found an unusual ally, at least on this issue, in Consumer Watchdog's John M. Simpson, who worked closely with some firms during CIRM hearings on its IP policy. He came up with a constructive proposal in June to deal with business issues that was brushed off by Klein.

But, as on any matter, there is not complete unanimity within the industry about CIRM. Funded firms are not likely to complain much.

CIRM has an additional $5 billion reason to move concretely to deal with biotech's concerns. Klein is touting for the ballot a CIRM bond measure of that magnitude, possibly in two years. The electoral campaign that created CIRM six years ago cost $30 million. Another ballot measure will run upwards of that amount, which means raising buckets of cash. And the only likely major donors will come from the biotech industry and its investors.

(A footnote: CIRM disputes statistics produced by BayBio on the percentage of awards given to business. We suspect the industry's figures were based on earlier grant numbers published by CIRM. The agency's totals change each time it approves another grant round every month or so. The presumably old percentages probably indicate that BayBio has been stewing over this issue for quite some time. BayBio has also filed a comment on an earlier item on this subject. Its carefully worded remarks said the August meeting created “a renewed sense of collaboration and areas to address.” BayBio did not speak to CIRM's criticism of its statistics.)

One Hour Public Access at Critical Two-Day Review of $3 Billion State Stem Cell Operation

The California stem cell agency today officially notified the public for the first time about next month's sweeping review of its operations and said the public may attend for one hour at the beginning of two days of meetings.

CIRM's announcement was the first such notice that it has given the public via its Web site about the sessions that begin Oct. 13 at its San Francisco headquarters. The announcement also said for the first time that the public can submit written comments and questions in advance of the meeting.

CIRM's announcement did not make it clear that the public would be barred from the remainder of the sessions. However, a separate agenda for the meeting, also the first to be published by CIRM, specified that public would, in fact, be banned from virtually all of the most comprehensive review ever of the $3 billion operation.

The California Stem Cell Report last week wrote that the agency planned to ban the public entirely from the sessions. It was the first public news of the external review outside the sparsely attended meetings of the CIRM board of directors. Yesterday, we pointed out that the ban is not in the best interests of either the public or the agency and that the secrect testimony would not accomplish the agency's goal of candor from witnesses.

Today's announcement from CIRM implicitly recognizes that the public has a right to attend the hearings. However, barring the public from the remaining 19.5 hours falls far short of being either open or transparent, something CIRM has had problems with for years. One hour could not even be considered paying lip service to the state Constitution's guarantee of a broadly construed right of public access to the doings of state government.

CIRM gave no reason for its marginal change of position. We are querying the agency concerning its reasoning.

Material posted by CIRM also shows a change in one of the panelists. Dropped is Myrtle Potter, former head of Genentech who now runs her own San Jose, Ca., consulting firm. No explanation was given for the removal of Potter. We are querying CIRM about that as well. She is being replaced by
Igor Gonda, CEO of Aradigm Corp. of Hayward, Ca., an inhalation drug product firm.

The agency also posted a 384-page briefing document that has been given to the eight panelists who will be reviewing CIRM's strategic plan.

We will have more later on all this.

Credibility Damaged and Foes Aided: No Upside on CIRM's Ban on the Public

The California stem cell agency's ban on the public during the most sweeping review ever of its operations promises little upside for the $3 billion enterprise and plenty of downside.

That's not to mention the fact that the ban is poor policy and is not likely to achieve its stated purpose – candor from those testifying before the blue-ribbon, international panel that has scheduled three days of hearings in San Francisco beginning Oct. 13.

The “external” review, as CIRM has labelled it, is called for by the agency's strategic plan of 2006. That document recognized the need to revise the plan as conditions changed. It was prepared with substantial comments from the public and a number of open hearings,

CIRM has devoted about 2,000 hours of staff time preparing for the the latest review, which will be critical in determing how the agency will spend its remaining $2 billion. The eight-member panel, which includes a Nobel laureate, is expected to prepare a report that will be considered by the CIRM board in December.

The strategic review comes as CIRM Chairman Robert Klein is publicly discussing presenting to voters a $5 billion bond measure to continue CIRM's activities. A bond measure is necessary because the agency's only real source of funding is cash that the state borrows (bonds). Klein's new bond proposal places the agency's efforts squarely in the context of a political campaign, which could come as early as two years from now.

Last week CIRM told the California Stem Cell Report that members of the public would be barred from attending the agency's external review. CIRM also has made no public effort to solicit comment from California citizenry, which is paying $6 billion, including interest, for the research program. Nor has CIRM notified the public via its Web site that an important evaluation of CIRM will take place.

Don Gibbons, spokesman for CIRM, said the closed-door sessions were necessary so that “reviewers can ask tough questions and receive candid, unfiltered responses” from CIRM staff, biotech executives and some CIRM board members who are scheduled to appear before the review panel.

The reality, however, is much different. CIRM staffers who want to keep their jobs are not going to say anything to reviewers that they haven't already told their superiors. Biotech executives who want to receive grants or loans from CIRM are unlikely to be sharply critical of the agency. And CIRM board members are more than likely to be circumspect, given that they have to make the final judgment on whatever the panel comes up with.

Only a “small number” of the 29 board members have been invited to make comments to the panel. Their identities and topics are yet to be disclosed.

The closed-door proceedings pose a problem for any CIRM board members who might want to sit in on a session or two. Essentially, they must ask permission of the CIRM staff to attend. That's because if too many of them attend, they could run afoul of the state's open meeting law by either constituting a quorum or creating what is known as a “serial meeting.”

Board members have sometimes complained about having to act with too little information. The primary example is appeals on grant applications. The board has repeatedly been asked to overturn negative decisions by grant reviewers, but cannot actually examine the actual applications. In January 2009, the board was caught by surprise when its bond funding was endangered. That particular problem was in evidence to knowledgeable persons well prior to that meeting and could have been disclosed to the board earlier. Limiting directors' attendance at the external review distances the board even more from key aspects of CIRM operations.

Last week we polled CIRM directors about whether they thought that the external review should be open. While we can't say our email reached all directors, we believe most saw it. Four responded. Only one director, Jeff Sheehy, said yes. Others may feel likewise while some are opposed, but at the same time feel constrained about responding via our query.

Director Floyd Bloom, former editor of Science magazine, said he did not see a need for the public to able to attend the review, He said the panel's report will be considered later by CIRM directors, and the public could comment then. (You can read all of the results here of the query including comments from some directors.)

CIRM has yet to provide a legal justification for closing the review. However, little doubt exists that the agency believes the ban on the public is lawful. Presumably CIRM would make a similar argument to one presented last July in connection with another CIRM meeting that barred the public.

However, those arguments fail to take into account a major change in the state Constitution in 2004 that guaranteed the public a broadly construed right to access to governmental affairs. The state's open meeting laws were written before that change and have not yet been amended to reflect its broader constitutional access provisions.

From a political and good government perspective, the ban on the public, coupled with continuing complaints about a lack of transparency at CIRM, unnecessarily provide major ammunition to its foes along with the foes of hESC research across the nation. Closed-door proceedings breed suspicion, even on the part of a public inclined to support stem cell research. They provide a fertile ground for the worst sort of rumors and add evidence that CIRM is an “insiders club,” as others, including Nature magazine, have complained. No doubt exists that Klein's $5 billion bond measure campaign will have to confront severe criticism about the lack of openness at CIRM.

One reader of this report, who is knowledgeable about CIRM affairs but who must remain anonymous, told us,

“The failure to provide any opportunity for public input in the process diminishes its credibility and utility. This is a hand-picked body following a pre-determined agenda that was defined  by CIRM. CIRM (i.e. Klein) decides what's presented and what's considered. The outcome is predictable.”

CIRM carries a special burden in connection with openness and transparency because of its unprecedented nature. As opposed to other state departments, it is not subject to normal oversight by the governor and the legislature. Funds flow to it unaffected by the financial crisis that is damaging public education and medical assistance to the poor in California.

Gov. Arnold Schwarzenegger has been advocate of more openness throughout state government and also a strong supporter of CIRM's operations. He has opened up other state departments' activities, including executives expense accounts, to public scrutiny. He said some time ago,

“Transparency is fundamental to promoting efficiency and effectiveness in government and strengthening the democratic process by giving citizens enough information to reach their own conclusions about how their tax dollars are being spent.”

CIRM should reconsider its position and open the external review to the persons who are actually financing its operations.

Text of CIRM Board Members Responses on Public Ban at External Review

Last week we sent an email to directors of the California stem cell agency and posed the following question.

“Do you think that the October review of CIRM's progress should be open to the public?”

We also told them that we would carry the text of any comments verbatim.

Four directors responded. Here are their comments.

Jeff Sheehy, a communications manager at UC San Francisco and a patient advocate member on the board, gave a one word response.

“Yes.”

Ed Penhoet, co-founder of Chiron and serving on the board as an executive officer of a commercial life science entity , said,

“Sorry, David, but I don't think that CIRM should conduct its board
business through an intermediary.”

David Serrano Sewell, a San Francisco deputy city attorney and a patient advocate member on the board, said,

“Here's my question to you, does this meeting qualify as a public meeting under the applicable state law requiring public meetings? No, it does not. At a minimum you've got to say that, this meeting is not required by state law to be a public meeting. Obviously, you think it should be, but it's not required.”

Floyd Bloom, former editor-in-chief of Science magazine and serving on the board as an executive officer from a California university, said,

“This aspect of the forthcoming review has not been discussed at any meeting at which I have been present, so this view is entirely my own, but I do not see the need for the Panel of Internationally distinguished scientist's review of CIRM's progress and achievements to be a Public Meeting.

“The 2006 Strategic Plan that authorized this outside review specifically calls for the report of the review committee to be made the ICOC:

"'The review will be reported to the ICOC who will consider the recommendations made in the review and, on that basis, approve modifications to the strategic plan.'

“As such the Public will hear what the outside experts have determined about the matters they have been asked to review and at the presentation to the ICOC there will be the standard opportunity for public questions and statements.” 

Stem Cell Agency Bans Public from Critical Review of its Operations

The California stem cell agency said yesterday it will bar the public from three days of the most sweeping hearings ever into how well it is spending $3 billion in taxpayer funds.

The blue-ribbon assessment of the California Institute for Regenerative Medicine will be the first such in the agency's five-year history and will be critical in determining how CIRM will spend its remaining $2 billion. The sessions also represent the most exhaustive review of the agency's past performance. CIRM has already committed more than $1 billion to 364 scientists and institutions.

Although CIRM directors have been told that the review will occur, the public has not been notified via CIRM's Web site or other means that the Oct.13-15 assessment will take place. Nor has the agency publicly solicited from citizens or other interested parties comments or suggestions of issues to be addressed.

CIRM has repeatedly come under fire from state officials for its lack of transparency. An influential state lawmaker said last February that the agency is “essentially accountable to no one.” The ban on the public at the October review also appears to fly in the face of a state constitutional amendment adopted in 2004. By an overwhelming 83 percent, voters altered the constitution to guarantee the public a broadly construed right of access to what state government is doing.

John M. Simpson of Consumer Watchdog of Santa Monica, Ca., a longtime observer of CIRM, said that conducting the "entire process behind closed doors shows an agency with leaders who are completely unaware of their responsibility to the public, or worse, don't care." (The full text of his remarks can be found here.)

Responding to a query, Don Gibbons, chief communications officer for the agency, told the California Stem Cell Report that the closed-door sessions are justified so that “reviewers can ask tough questions and receive candid, unfiltered responses” from CIRM staff and board members, among others.

Gibbons said in an email,

“The reviewers are not public officials and have no governmental authority; they were asked to serve by staff not the CIRM board. They have been asked to give their opinion, not make decisions.”

He said that the reviewers will produce a written report during their closed-door sessions that will be reviewed by the CIRM board of directors in a public meeting. (All of Gibbons' remarks can be read here.)

The “external review,” as it is known, is called for by the agency's strategic plan. CIRM President Alan Trounson told directors in August that preparation for the meetings at CIRM headquarters in San Francisco is taking 2,000 hours of staff time.

The sessions will be conducted beginning Oct. 13 by an eight-member panel. The members are Alan Bernstein, executive director of the Global HIV Vaccine Enterprise of New York, NY; George Daley of Harvard and director of stem cell transplantation at the Children's Hospital and Dana Farber Cancer Institute; Sir Martin Evans, Nobel Laureate and director of the School of Biosciences of Cardiff University of Great Britain; Judy Illes, director of the National Core for Neuroethics at the University of British Columbia; Richard Insel, executive vice president of Research for the Juvenile Diabetes Research Foundation of New York, NY; Richard Klausner, formerly the global health executive director of the Bill and Melinda Gates Foundation's Global Health program and now an independent consultant, Myrtle Potter, now head of her own consulting firm and former president of Genentech, Inc., and Nancy Wexler, Higgins Professor of Neuropsychology in the Departments of Neurology and Psychiatry at Columbia University and president of the Hereditary Disease Foundation. (Full biographies can be found here.)

Two of the panelists have links to CIRM. Daley is a scientific co-founder and co-chair of the scientific advisory board of iPierian, Inc., of South San Francisco, which holds a $1.5 million grant from the agency. Ipierian is expected to apply for an award in CIRM's upcoming, $50 million clinical trials round. Daley is also an ad hoc member of the CIRM grant review committee and serves on a national consortium created by CIRM.

Potter served for six years on a panel that is charged with overseeing CIRM's financial operations, the Citizen's Financial Accountability Oversight Committee.

Insel's organization has longstanding ties with CIRM Chairman Robert Klein, who currently serves on the foundation's board of chancellors.

Consumer Watchdog's Simpson said,

"This evaluation looks to be conducted by insiders, some with clear conflicting ties to CIRM. That is highly improper and inappropriate."

In response to a query, Gibbons outlined the order of business for the review. He said,

“The first day will be presentations by staff about various aspects of our operations and goals, with ample time for discussion during each session.

“The second morning will be presentations by the Chair (Klein) and his staff about governance and bonds, with the afternoon being given over to a series of discussions with small groups: members of the Grants Working Group, biotech execs, CIRM grantees, and patient advocates.

“The third day will begin with a Q&A session with Alan (Trounson) and then the reviewers will begin to outline the draft of their report with only a facilitator present.”

Later, Gibbons added,

“A small group of board members will be interviewed by the group the second afternoon.”

The California stem cell agency has drawn strong criticism for its lack of openness. Last February, state Sen. Elaine Kontaminas Alquist, D-San Jose, chair of the Senate Health Committee, said CIRM is “essentially accountable to no one.” In January, the Citizens Financial Accountability Oversight Committee, chaired by the state's top fiscal office, Controller John Chiang, unanimously recommended more transparency at CIRM. Commenting on the committee's action to CIRM directors last February, Trounson said it was an "irrational attack on the governance of the institute without any real information backing it up."

The Little Hoover Commission, the state's good government oversight group, last year prepared an 88-page report on CIRM. The commission's recommendations included improved transparency, noting that it would help to ease criticism that CIRM amounts to an “insider's club.”

CIRM is not subject to normal state oversight, including that of the governor and the legislature. Under the terms of Prop. 71, which created the agency in 2004, CIRM is immune from the usual budgetary controls imposed on other state departments. Its funds, which come from state bonds, flow to CIRM directly and cannot be touched by the governor or the legislation.

Text of CIRM Comments on October Review of its Operations

Here is the text of what CIRM has told the California Stem Cell Report (CSCR) concerning the California stem cell agency's October review of its operations. All responses were given via email by Don Gibbons, CIRM's chief communications officer, in response to questions, also via email.

CSCR query Sept. 13, 2010

“Please send me the schedule and location for the external review sessions in October.”

CIRM response Sept. 13, 2010

“It will be at CIRM headquarters October 13, 8:00-6:15; October 14, 8:30-7:15; and October 15, 9:00-5:00”

CSCR query Sept. 13, 2010

“Is there a particular agenda or order of business? Will the strategic plan or elements of the plan be examined page by page or section by section or ?”

CIRM response Sept. 20, 2010

“The first day will be presentations by staff about various aspects of our operations and goals, with ample time for discussion during each session.

“The second morning will be presentations by the Chair and his staff about governance and bonds, with the afternoon being given over to a series of discussions with small groups: members of the Grants Working Group, biotech execs, cirm grantees, and patient advocates.

“The third day will begin with a Q&A session with Alan (Trounson) and then the reviewers will begin to outline the draft of their report with only a facilitator present.”

CSCR query Sept. 20, 2010

“I assume that all of these sessions are open to the public, right?”

CIRM response Sept. 22, 2010

“The reviewers will not meet in public. A review of this nature will only be valuable if the reviewers can ask tough questions and receive candid, unfiltered responses.

“The reviewers are not public officials and have no governmental authority; they were asked to serve by staff not the CIRM board. They have been asked to give their opinion, not make decisions. Their opinions will be placed in a public document not edited by CIRM.

“If CIRM board members, as public officials, seek to take any action on the basis of the report, they would do that through public meetings.”

CSCR query Sept. 22, 2010

“Do any board members plan to attend the meeting? Will they be barred from the sessions?”

CIRM response Sept. 22, 2010

“A small group of board members will be interviewed by the group the second afternoon.”

Text of Consumer Watchdog Remarks on Closing of CIRM External Review

Here is the text of the comments from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., on the closed-door, “external review” that the California stem cell agency has scheduled for October. Simpson made his response as the result of an inquiry from the California Stem Cell Report.

"One might justify a brief executive session during a three-day review of
CIRM, but to hold the entire process behind closed doors shows an agency
with leaders who are completely unaware of their responsibility to the
public, or worse, don't care.

"This evaluation looks to be conducted by insiders, some with clear
conflicting ties to CIRM. That is highly improper and inappropriate. I had
thought CIRM's leaders finally understood that they are public officials.
Clearly they do not."

"Despite what Alan Trounson and Bob Klein may think, CIRM is not a private
club where they may do whatever they wish."