Zach Hall Remarks

Here are the prepared remarks of Zach Hall before the legislative hearing.

Good afternoon Senator Ortiz and Joint Health Committee members. My name is Dr. Zach Hall, Interim President of the California Institute for Regenerative Medicine, a job that I have held for exactly one week. I want to thank you, Senator Ortiz, for the opportunity to appear at this special hearing on implementation of the California Institute for Regenerative Medicine. I would like to begin by briefly introducing myself. I am trained as a basic neuroscientist and spent most of my career as a faculty member and department chair at the University of California, San Francisco. In 1994, I had the unusual opportunity of going to the National Institutes of Health (NIH) as the Director of the National Institute of Neurological Disorders and Stroke (NINDS), the leading agency world-wide in funding research on the brain. As Director, I was responsible for a research program that awarded more than $500 million a year in grants and contracts to investigators across the country. Since my time at NIH, I have been a research administrator, both at the University of California, San Francisco, where I was Executive Vice Chancellor, and at the University of Southern California, my most recent position.
As NINDS Director, I became acutely aware of the ravages of neurological diseases such as Alzheimer’s disease, Parkinson’s disease and multiple sclerosis, and of the large numbers of Americans who are afflicted by these disorders. Moreover, I faced every day the fact that for most neurological disorders we have no effective nor definitive treatments. The tragic dimensions of neurodegenerative disease and its burden for patients and families were brought home to me in a very personal way about ten years ago when my mother was diagnosed with Alzheimer’s disease, a disease that slowly and painfully stole her memory, her reason and her ability to recognize loved ones until her death two years ago.
Like many Americans, I followed the ground-breaking recent research on stem cells with hope and excitement, and, like many Americans, I was dismayed by the Executive Order of August 9th, 2001, severely limiting the number of stem cell lines eligible for federal government funding. These restrictions were discouraging to many scientists and have significantly slowed the pace of stem cell research in this country. The appearance of Proposition 71 offers
bold alternative to revitalize the stalled Federal effort and put California in the scientific and economic vanguard, pioneering new science and medicine for the benefit of mankind. My personal involvement with the Initiative began about two months ago when I met with ICOC Chairman Bob Klein for the first time to hear about the exciting plans for the Institute. To participate in this new historic venture as Interim President is for me a personal and professional opportunity of the highest order.
As you know, the California Institute of Regenerative Medicine was established in 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Initiative. The statewide ballot measure, which provides $3 billion in funding for stem cell research at California universities and research institutions, was approved by 59.1 percent of California voters. It called for the establishment of an entity, the California Institute for Regenerative Medicine, to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. More Californians voted on Proposition 71 than on any other ballot measure during the last election.
One reason for the success of Proposition 71 is the support it enjoyed from a broad coalition of patient advocacy groups, from the scientific community, including 35 Nobel Laureates and a “who’s who” of Californian scientific and research leaders, 30 medical groups from leaders in the faith community, business and labor and from community and advocacy groups. A copy of the organizations and individuals who endorsed Proposition 71 has been provided to you.
Following passage of the bill, an outstanding group of leaders in medicine, science, business, and disease advocacy was appointed to the 29 member Independent Citizens’ Oversight Committee (the “Board”) by the Governor, Lt Governor, Controller, Treasurer, President Pro Tem, and Speaker. I am proud to serve as Interim President under this distinguished Board. Its members include:
• Dr. David Baltimore, a Nobel Laureate and President of the California Institute of Technology;
• Dr. David Kessler, former Commissioner of the federal Food and Drug Administration and Dean of the School of Medicine at UCSF;
• Deans of the Schools of Medicine at UC San Diego, UCLA, UC Davis, Stanford and USC, and the Chancellor of UC Berkeley
• The presidents of the Salk Institute, the Burnham Institute, and the City of Hope
• Disease advocacy leaders like Sherry Lansing (Chairman of Paramount Pictures), Joan Samuelson (President of the Parkinson’s Action Network), and Jeff Sheehy (San Francisco’s “AIDS Czar”) and seven other leaders.
• Gayle Wilson, former first lady of California, and other representatives of the business community.
The charge of the Board is to create a new agency which will transform biomedical research. In the scant two and a half months of its existence, the Board has made excellent progress toward that goal.
Since January 1, the full Board has met three times (January, February, March) and has established five sub-committees which have, in aggregate, met seven times. Two of the committees, the Presidential Search Committee and the Site Committee, are responsible for recruiting a permanent president and for finding a permanent site for the Institute, respectively. The Presidential Search Committee has engaged a professional search firm (SpencerStuart) to identify and make a preliminary screen of outstanding candidates. The Site Committee has issued an RFP for site proposals, which are due on March 16th.
The three other sub-committees of the Board are responsible for setting up the three permanent Working Groups that will serve the Institute in its on-going work. These are:
1. The Scientific and Medical Research Funding Working Group (the “Grants” Working Group) which will be responsible for scientific evaluation of grant proposals to the Institute.
2. The Scientific and Medical Accountability Standards Working Group (the “Standards” Working Group) which will recommend scientific, medical and ethical standards for stem cell research and clinical trials and therapy delivery to patients.
3. The Scientific and Medical Facilities Working Group (the “Facilities” Working Group), which will make recommendations to the Board on grants and loans for facilities for stem cell research.
In its effort to recruit the best minds nationwide to the Working Groups, the subcommittees have met to determine search criteria, process and timelines. Over 500 potential candidates are currently being reviewed for membership on the Working Groups by committee members. We hope recommendations for membership of all of the subcommittees will be completed by the May Board meeting. Please note that all of the Working Group subcommittees, as well as the Board, meet in public in strict accordance with the Bagley-Keene Open Meeting law. Moreover, the names and resumes of all prospective appointments to the Working Groups will be made public before their consideration by the Board to allow comment.
The job of President, as defined in the Initiative, is to hire the scientific and administrative staff of the Institute and to direct its day-to-day operations. I am pleased to report to you that interim headquarters for the Institute have been established in Emeryville and that 11 staff members have been hired. One of those is Walter Barnes (a 39-year veteran of state service who is on loan from the State Controller’s Office to implement the financial systems of the Institute. We are just beginning, under my leadership, to hire scientific personnel. Just yesterday we posted a position for our first scientific staff member, the Director of Scientific and Review Programs, who will be hired through a competitive process.
Thus we have made a strong beginning, but we have a daunting task before us – to build a new Institute from the ground up. Nevertheless, we are confident that we will be able to begin our first grant-making activities in a few months.
Following this general introduction, I would like to address specific comments to the Agenda item of the Oversight Hearing. Let me say at the outset that the success of our venture will critically depend on the confidence of the people of California in our integrity and credibility. Decisions made by the Institute must be transparent and must be perceived to be fair and objective judgments based on scientific merit, free of bias and conflict of interest. To achieve this end, we welcome public comment and strongly desire to forge a positive working relationship with the California Legislature.
Open Meetings
The ICOC is deeply committed to the principles of transparency and public meetings in all cases other than those in which specific open meeting law exemptions apply. All Board meetings and all Board sub-committee meetings are held in strict accordance with the Bagley-Keene Open Meeting Act. Notification is given at least 10 days in advance of each meeting to all persons who have requested it, and agendas and other information are posted on the Institute website (www.cirm.ca.gov), including material not required by law. Public comment is welcomed at every Board meeting, and all meetings to date have benefited from robust citizen participation. The ICOC has taken the public’s comments into account in all of its work, and many of the individuals you have as witnesses today have spoken repeatedly at Board and subcommittee meetings. It is important to understand that absolutely no grant award shall be made and no medical or ethical standards established outside the public Board meetings. All grant awards and adoption of all standards shall be considered, discussed and approved only in open ICOC meetings.
In contrast, deliberations of the advisory Working Groups will be held in private as required in the Initiative. These groups are not responsible for decisions, but for evaluations to be considered at open ICOC meetings. Confidentiality in the Working Group meetings is essential to obtain valid evaluations from peer reviewers. The concept of “peer review”, which will be the primary method for evaluating grants, is widely recognized to be the best method of obtaining expert scientific opinion and is followed not only by the NIH but by virtually every disease advocacy organization that funds biomedical research. In each case, review is carried out under confidential conditions, which are necessary to obtain rigorous and candid scientific reviews of the merit of proposals, including candid evaluations of the scientific track record and capabilities of the scientists who will conduct the research. No scientist will offer frank reviews in an open meeting in which his or her remarks could be seen as public criticism of a colleague and peer.
A second reason for confidentiality is that researchers commonly include in their proposals significant detail about their planned research, such as detailed descriptions of novel ideas, and unpublished results. It is important that investigators be able to submit such information in a confidential environment, lest their ideas be at risk of being appropriated by others, and lest any propriety information they share be open to public disclosure.
The same principle applies for the Standards Working Group which will have the important job of making recommendations to the ICOC for development of policy on medical and ethical standards and then subsequently address compliance issues. Because sensitive subjects must be dealt with, including real-life examples that have presented problems, confidentiality is essential. Public discussion could have a negative impact on the practicing physicians and operating medical centers featured in a given example. Individuals’ concerns about the potential repercussions of public scrutiny could have a chilling effect on honest discussion.
Dr. Bruce Alberts, President of the National Academies, has addressed some of these issues in a letter to the Chair of the ICOC. (A copy is provided to you.) James Wright, General Counsel of the National Academies may address these issues further in his remarks.
Conflict of interest
Conflict of interest is an extremely important issue for the Institute. We are committed to having strong standards for all of those associated with the work of the ICOC and the Institute. Conflict of interest issues arise at several levels: for Board members, for Institute staff, for Working Group members and for grantees. I will address each of these in turn.
1) Each of the Board members have filed individual Form 700 statements of economic interests consistent with state law and Fair Political Practices Commission regulations. In addition, please note that the Initiative states that Board members cannot vote on requests for grants from his or her institution. A more comprehensive Conflict of Interest policy has already been reviewed by the Board at its March meeting and, following outside comment from the National Academies, will be returned for further consideration in April.
2) The Board of the Institute has adopted strong disclosure requirements and conflict of interest policy for employees of the Institute. At its meeting last week the Board adopted an Incompatible Activities Statement for employees. This statement is modeled on the comparable statement for other State of California employees.
3) For the working groups, the ICOC is developing policies for members that will be based on the federal NIH guidelines on conflict of interest for review group members. Our goal is to bring these to the Board at the May meeting, at the time the Working Group members are scheduled to be selected. Additionally, to avoid conflict of interest, the Standards Search has recommended to the Board that all peer reviewers of the Grants Working Group – the scientists and physicians who judge the scientific merit of proposals -- be from out of state. Please note that this standard exceeds that of the NIH.
4) For grantees, we will develop conflict of interest guidelines that are based on those of the NIH. Recommendations for these guidelines will be made by the Standards Working Group once it is established, and then brought to the ICOC for final discussion and approval.
Patents and Intellectual Property
It is our hope that the discoveries funded by the Institute that are made in the laboratory will lead to effective treatments in the clinic. To bring effective treatments to market, partnership between academic and commercial researchers will be essential, and we will need to engage commercial firms in our efforts. In anticipation of this partnership, Proposition 71 included four commercial life sciences seats on the ICOC.
Intellectual Property and patents are essential to the movement of discoveries form academia into the private sector. Proposition 71 requires that Intellectual Property agreements be included in every grant and loan award. These agreements will allow the State to share in the gains from any patents or other Intellectual Property developed with Initiative funding. Formulation of the principles that guide these agreements will be a major task for the Board. Because of the range of activities of the Institute, specific IP agreements will necessarily depend upon the type of grant, as well as the type of research funded. The overall policies, as well as each specific agreement, dealing with Intellectual Property rights arising from research funded by the Institute will be discussed and adopted in public ICOC meetings.
In formulating these policies, the Board will cooperate closely with the California Council on Science and Technology (CCST) to develop best practices for state-funded IP agreements. A CCST committee was created by Assembly Concurrent Resolution 252 sponsored by Assemblyman Gene Mullin with a charge of identifying best practices for Intellectual Property funded by the State. Two members of the Institute Board will serve on the committee, which is expected to meet shortly.
Medical and Ethical Standards for Research
The Institute is committed to creating comprehensive medical and ethical standards through a deliberative process that incorporates recommendations from many sources. No research grants will be funded until ethical and medical standards are in place.
Many of the medical standards, dealing with informed consent and scientific integrity, can be adopted from NIH standards. Others are specific to stem cell research. Many outstanding research institutions engaged in stem cell research, such as Harvard, University of Wisconsin, Stanford and the University of California San Francisco have formulated standards that we will consider in formulation of policy. In particular, we will look to the guidelines for stem cell research that are being developed by a blue-ribbon committee of the National Academy of Sciences and the Institute of Medicine. The publication of these guidelines is expected next month. This will be an important event as they will represent the first major consensus standards for stem cell research, promulgated by one of the nation’s premier science advisory bodies.
Proposition 71 itself deals with several of these issues. For example, the Initiative prohibits compensation to research donors or participants and permits only reimbursement of expenses. Surplus products of in vitro fertilization treatments may be donated only under appropriate informed consent procedures. Proposition 71 also reinforces existing California state law by prohibiting funding for reproductive cloning.
In addition to the specific standards mandated by Proposition 71, Institute-funded research will be subject to federal regulations for research involving human subjects for clinical trials. Institute -funded research is also subject to federal patient rights, safety and privacy protections.
In formulation of its policies, the Institute would like to cooperate with the Human Stem Cell Research Advisory Committee created under Senate Bill 322 by Senator Ortiz that is charged with developing medical and ethical guidelines for stem cell research funded in the state by private sources. The Institute looks forward to the convening of the SB 322 committee.
Disease Disparity and Diversity Issues
The California Institute for Regenerative Medicine is committed to a diverse workforce. To begin the operations of the Board and Institute we have used direct recruitments to hire 11 persons. These persons are involved in administrative work related to establishing the Board and Institute, including providing support to the ICOC and the various subcommittees that have been appointed to develop recommendations for grant and loan standards and procedures for the ICOC to consider and adopt.
The first formal recruitment was my own, for which there were three finalists. We have now initiated a competitive search, as described above, for a Director of Science Programs and Review. Both in my work at NIH, and at UCSF and USC, I have always been personally committed to diversity in the work force, as a very positive value. It is our intent that all future hires will result from extensive recruitments designed to attract as diverse a group of candidates as possible. In the meantime, any new workload needs are being addressed by temporary loans through interagency agreements and by short term contracts. Once the recruitments are completed and final candidates selected, these interagency agreements and short term contracts will cease to exist.
We have been contacted by several organizations interested in helping us to achieve our goal of a diverse employee population. We will consult with them and welcome any further suggestions from the committee for others we might meet with.
Auditing and Public Accountability Issues
Financial accountability provisions are built into Proposition 71. Proposition 71 requires the Institute to undergo an annual independent financial audit of its activities and creates an unprecedented Citizens’ Financial Accountability Oversight Committee, chaired by State Controller Steve Westly, with additional members appointed by the Treasurer, Speaker, Controller, President Pro Tem and the ICOC, which is expected to meet within the next 90 days. Once this committee has reached a decision on its financial program, the Institute would be pleased to report this information. This committee shall set guidelines for, review, and issue a public report on the annual audit.
The Initiative also states that general administrative costs of the Institute are limited to 3 percent of grant commitments, while less than an additional 3 percent is reserved for research administration costs.
To assure the highest standards of fiscal accountability, we are working closely with the State Controller’s office to implement sound financial and accounting systems, and for the direction in setting up audit processes and reviews of those systems. This program will include test audits to validate and refine the system, after it is established.
A Finance Committee, chaired by State Treasurer Phil Angelides, which will also include the Director of Finance and representatives of the Controller and ICOC, will guide Institute financing decisions, determining whether or not it is necessary or desirable to issue bonds authorized pursuant to Proposition 71 and, if so, the amount of bonds to be issued and sold.
Summary
In summary, the Institute must work closely with the State Legislature and the executive branch of State government if it is to be successful and to achieve the high standards of integrity and excellence to which we aspire. We look forward to working further with you and your colleagues to explore important issues involved with implementation and operations of the Institute.
Most of all, we look forward to collaborating with you to advance stem cell research – together we can make medical history in California.

Genetics and Society Media Advisory

Here is the media advisory from the Center for Genetics and Society.

UNREGULATED STEM CELL RESEARCH MAY PUT WOMEN’S HEALTH AT RISK
Pro-Choice Groups Will Raise Concerns about an Expanding Market for Women’s Eggs at March 9 Senate-Assembly Committee Hearing

Who: The Pro-Choice Alliance for Responsible Research, Our Bodies Ourselves, the Center for Genetics and Society, and Suzanne Parisian, M.D., a former chief medical officer for the FDA, have joined together to call attention to the need to regulate the harvesting of women’s eggs for stem cell research.

What/Where/When: Members of the pro-choice groups will testify about the need for regulation of egg extraction and other aspects of stem cell research at the hearing of the California Legislature’s Implementation of Proposition 71 Oversight Committee, chaired by State Senator Deborah Ortiz, on Wednesday, March 9, 2005 from 1:30-5 pm, State Capitol, Room 4203, Sacramento, California.

“I strongly urge that sound ethical and medical practices are adopted regarding the manner in which eggs are extracted from healthy women for research purposes,” said Suzanne Parisian, M.D., a former Chief Medical Officer of the U.S. Food and Drug Administration. “As a scientist, I understand why some have expressed enthusiasm for SCNT [somatic cell nuclear transfer; also referred to as embryo cloning, research cloning, or `therapeutic’ cloning]. But as a physician, I cannot condone SCNT at the potential expense of a woman’s health without giving her an opportunity for adequate informed consent and establishing a mechanism to ensure her safety.”

Dr. Parisian is a board-certified pathologist as well as a researcher in genetics and developmental biology. She details her concerns in an open memo for scientists, physicians, legislators, press, and public health advocates who have an interest in SCNT research, available at http://www.genetics-and-society.org/ .

Both the drugs used to “shut down” women’s ovaries and those used to “hyperstimulate” the ovaries to produce multiple eggs are associated with serious adverse reactions, in some cases life-threatening. Deaths have been reported.

Concerns about the health risks of egg extraction are gaining new urgency because of the prospect of increased demand for women’s eggs for SCNT research, state funding for which was authorized by Proposition 71. Women’s health and rights leaders have long advocated that women have the right to make informed choices about procedures that will affect their bodies. Many question whether women can give truly informed consent to provide eggs when the risks have not been adequately studied.

“The long term risks of the hormonal drug treatments used for egg extraction have not been adequately studied,” said Judy Norsigian, co-founder of the Pro-Choice Alliance for Responsible Research and executive director of Our Bodies Ourselves. “We should wait until the Centers for Disease Control and others collect more complete data on risks for both these women and their offspring. We already do know about short term problems including ovarian hyperstimulation syndrome, which in relatively rare instances has caused severe problems, including death. Many of these drugs have never been approved by the FDA for the purposes of egg extraction.”

Public policy organizations believe further study is warranted.

“If researchers begin experimenting with SCNT on a large scale, they will need eggs from many thousands of women. Payment to these women for their eggs, even if it is considered reimbursement, would create an economic inducement for women to put themselves at risk. This would be especially true for poor and young women,” said Marcy Darnovsky, associate director of the Center for Genetics and Society.

“Unlike other types of medical research, where testing on human subjects occurs only much later in the process and after laboratory experiments have indicated that certain safety levels have been achieved, SCNT research requires that women be the first guinea pigs. Protecting women’s long term health must be our highest priority,” stated Susan Berke Fogel, co-founder of the Pro-Choice Alliance for Responsible Research.

At the March 9 hearing, the following recommendations will be made to the California state legislature:

California researchers should be required to adopt the safest and most ethical approaches to collecting eggs for SCNT or other research.

Extraction at the time of an ovariectomy or a tubal ligation would be far safer and more ethical than conventional multiple egg extraction procedures. Even single egg extraction with natural cycling (involving no hormonal manipulations of the ovary) would be safer than conventional methods.

Before undertaking multiple egg extraction from healthy women, all data on drugs used in such procedures should be reviewed by a neutral, knowledgeable, and independent oversight body whose sole purpose is to protect the safety and rights of women wishing to provide eggs. In order to accomplish this review, pharmaceutical firms must be required to disclose the FDA-approved indications and all available safety data on these drugs.

Before undertaking multiple egg extraction from healthy women, better quality data should be gathered that would make true informed consent possible for women considering providing eggs for research.

Every woman who provides eggs for research should have her own physician who is independent of the research and the research institution, and whose only job is to look out for the well-being of the woman.

Francke Statement

The following remarks were prepared by Terry Francke, general counsel for Californians Aware, to be presented at today's California Legislative hearing into the state stem cell agency.

“Thank you for sharing with me the March 1 letter from Bruce Alberts, president of the National Academy of Sciences (NAS) to Robert N. Klein II, Chairman of the Independent Citizens Oversight Committee (ICOC) of the California Institute for Regenerative Medicine (CIRM). “The letter explains the transparency rules governing NAS advisory committee meetings and records, and will, I gather, be presented as support for the ICOC’s apparent intention not to open to the public meetings of the Working Goups advising the ICOC. “There are several reasons why the NAS committee policies in this regard are not good models for those that should govern the Working Groups. “The NAS and the Federal Advisory Committee Act The NAS was incorporated by an act of Congress during the Civil War and charged, “whenever called upon by any department of the Government, (to) investigate, examine, experiment, and report upon any subject of science or art…” As noted on the NAS web site,
'Over the years, the National Academy of Sciences has broadened its services to the government. During World War I it became apparent that the limited membership -- then numbering only about 150 -- could not keep up with the volume of requests for advice regarding military preparedness. In 1916 the Academy established the National Research Council at the request of President Wilson to recruit specialists from the larger scientific and technological communities to participate in that work. 'Recognizing the value of scientific advice to the nation in times of peace as well as war, Wilson issued an executive order at the close of World War I asking the Academy of perpetuate the National Research Council. Subsequent executive orders, by President Eisenhower in 1956 and President Bush in 1993, have affirmed the importance of the National Research Council and further broadened its charter. 'Under the authority of its charter, the National Academy of Sciences established the National Academy of Engineering in 1964 and the Institute of Medicine in 1970. Much like the National Academy of Sciences, each of these organizations consists of members elected by peers in recognition of distinguished achievement in their respective fields. The National Academy of Sciences includes about 1,800 members, the National Academy of Engineering about 1,900, and the Institute of Medicine about 1,200. All three organizations also elect foreign associates.'
“The Federal Advisory Committee Act was passed in 1972 and for the next 25 years required that all meetings of a defined federal “advisory committee” be open to the public. The definition encompassed
'any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof…which is – (A) established by statute or reorganization plan, or (B) established or utilized by the President, or (C) established or utilized by one or more agencies, in the interest of obtaining advice or recommendations for the President or one or more agencies or officers of the Federal Government except that such term excludes (i) the Advisory Commission on Intergovernmental Relations, (ii) the Commission on Government Procurement, and (iii) any committee which is composed wholly of full-time officers or employees of the Federal Government.'
'
“(5 U.S.C. App. §3) “In Animal Legal Defense Fund v. Shalala, 104 F.3d 424 (D.C. Cir.), cert. denied, 118 S. Ct. 367 (1997), the U.S. Court of Appeals for the District of Columbia Circuit held that under the “established or utilized by one or more agencies” criterion, an advisory committee of the NAS that developed standards for animal experimentation for various federal agencies was subject to the FACA open meeting requirement. Toward the end of that year, a bill was introduced in the House and, thanks to rule suspensions in that body and unanimous consent in the Senate, was on the President’s desk within 30 days, to be signed into law on December 17. “In other words, the exemption from the FACA’s open meeting requirements that NAS advisory committees were granted for their deliberative sessions was itself achieved without hearings or deliberation. Whatever merit such an exemption may have as a model for California is therefore still, needless to say, open to debate. The only clue I have been able to find to the justification that would have been openly offered to the Congress had there been hearings and debate is in the November 5 statement of G. Martin Wagner, Associate Administrator of the General Services Administration, to the Subcommittee on Government Management, Information and Technology of the House Committee on Government Reform and Oversight. His statement (full text at http://www.gsa.gov/Portal/gsa/ep/contentView.do?pageTypeId=8199&channelId=-13338&P=XAE&contentId=11771&contentType=GSA_BASIC) makes it apparent that the NAS quarrel with the Animal Legal Defense Fund holding was principally that it extended FACA to NAS committee work operating under contract with federal agencies, even though NAS was only “quasi-public” and was “not subject to actual management and control by such agencies…” A proposed amendment turning on that distinction was abandoned in favor of the actual bill, introduced just two days later, which instead specifically gave NAS its express exemption. “The Deliberative Process Privilege “What rationale there is for the exemption is stated in Dr. Alberts’ letter: “Committee meetings that are not data-gathering committee meetings are not open to the public in order to protect the committee deliberative process.” In California law, the integrity of the deliberative process of the executive has been recognized by the California Supreme Court as one consideration to be weighed in the balance in determining whether records of the Governor’s office showing with whom the Governor met must be disclosed under the California Public Records Act. The high court resolved this question against disclosure in Times Mirror Co. v. Superior Court of Sacramento County, 53 Cal. 3d 1325 (1991), and since then two cases from the Court of Appeal have done likewise concerning records showing who has applied to be named by the Governor to fill vacancies on county boards of supervisors (Wilson v. Superior Court, 51 Cal.App.4th 1136(1996); California First Amendment Coalition v. Superior Court of Sacramento County, 67 Cal.App.4th 159(1998)). Only one case has applied what has come to be called the “deliberative process privilege” to a multi-member deliberative body, i.e. a city council, and in that case the issue was access to records of phone numbers called by council members over the period of a year (Rogers v. Superior Court of Los Angeles County, 19 Cal. App. 4th 469 (1993)). “Otherwise, California law on access to meetings of decision-making and advisory bodies in the legislative and executive branches of state and local government is uniformly contrary to the notion of a deliberative process privilege justifying exclusion of the public. The constitutional provisions requiring open meetings of the Legislature’s houses and committees acknowledge no such exemption from openness, nor do the Bagley-Keene Open Meetings Act governing state bodies generally, the provisions of that act applicable to the Board of Regents of the University of California, the Romero Act applicable to meetings of California State University student organizations, and the most thoroughly amended, litigated and interpreted statute of them all, the Ralph M. Brown Act, applicable to boards, councils, commissions and the advisory bodies thereto in local government. “This rejection of secrecy in the deliberative process has been resoundingly reinforced in the November 2 voter approval, by an 83.4 percent margin, of Proposition 59, amending the California Constitution to give citizens a fundamental right of access to “the meetings of public bodies.” The ballot argument for Prop 59 states, in part:
'What will Proposition 59 do? It will create a new civil right: a constitutional right to know what the government is doing, why it is doing it, and how. It will ensure that public agencies, officials, and courts broadly apply laws that promote public knowledge. It will compel them to narrowly apply laws that limit openness in government—including discretionary privileges and exemptions that are routinely invoked even when there is no need for secrecy. It will create a high hurdle for restrictions on your right to information, requiring a clear demonstration of the need for any new limitation. It will permit the courts to limit or eliminate laws that don't clear that hurdle. It will allow the public to see and understand the deliberative process through which decisions are made. It will put the burden on the government to show there is a real and legitimate need for secrecy before it denies you information. (Emphasis added)'
“In summary: “The exemption from the open meeting requirements of the Federal Advisory Committee Act granted by the Congress to the National Academy of Sciences in 1997 was achieved in extraordinary haste without public hearings or debate. There is no record of legislative intent or rationale. “The purpose of the exemption as articulated by NAS President Bruce Alberts —“ to protect the committee deliberative process”—is utterly alien to California law on meetings of official bodies. “California voters have overwhelmingly endorsed a constitutional principle to the contrary—underscoring their right “to see and understand the deliberative process through which decisions are made.” “Finally, if any argument were needed as to why the ICOC’s Working Groups are especially needful of public monitoring, it is the fact that the CIRM is otherwise so extraordinarily insulated from Legislative control and correction. The only oversight of the CIRM in its foundational years is provided by the ICOC. Since the task of the Working Groups is to present the ICOC with recommended standards and policies, and enforcement actions supporting them, the Working Groups should be as transparent as any committees of the Legislature.”

Ortiz Media Advisory

Here is the media advisory from Sen. Ortiz.

SENATOR ORTIZ HOLDS FIRST LEGISLATIVE OVERSIGHT HEARING ON THE IMPLEMENTATION OF STEM CELL RESEARCH

SACRAMENTO – Senator Deborah Ortiz (D-Sacramento) on Wednesday will hold the first legislative oversight hearing on the implementation of Proposition 71, the Stem Cell Research and Cures Act. The joint hearing will be conducted by the Senate Health Committee and the Senate Subcommittee on Stem Cell Research Oversight, both chaired by Ortiz; and the Assembly Health Committee, chaired by Assemblywoman Wilma Chan (D-Oakland).
Legislators will be provided their first opportunity to hear first-hand how the California Institute for Regenerative Medicine and the Independent Citizens Oversight Committee, the 29-member panel charged with overseeing implementation of Proposition 71, are designing the nation’s premier stem-cell research program. They also will hear about steps planned to ensure patient protection and public accountability.
“Voters overwhelmingly approved Proposition 71 because of the promise it holds for finding new medical breakthroughs for debilitating and life-threatening diseases that affect millions of Americans,” Ortiz said. “In approving this important research, voters also ponied up $3 billion to $6 billion of their hard-earned tax dollars. It is critical that Californians remain confident that their public dollars are well spent and the state receives a fair financial return on its generous investment – both in royalties and affordable access to therapies that are developed.”
Most of the hearing will be devoted to testimony from experts regarding several critical issues that were not addressed in the initiative, including: adopting conflict-of-interest and economic disclosure requirements to ensure members of the governing committee and working groups that award research grants are not tainted by financial holdings or affiliations with any university or disease advocacy group; determining how much of the work by the governing and working groups should be conducted in a public forum; ensuring the state receives a fair financial return on its investment through royalties and/or access to medical remedies and products developed; and adopting strict patient protection regulations and bans on financial gain for donating eggs.
Senator Ortiz is the author of SB 18, which addresses each of those areas. The bill is scheduled to be heard in the Senate Health Committee in April.

Greenlining Statement

The following letter dealing with supplier diversity was submitted by Jorge Corralejo to Sen. Ortiz as part of the Greenlining Institute's presentation for the committee hearing on the stem cell agency.

“As a board member of the Latin Business Association and of the Greenlining Institute, I wish to express my concerns regarding the $3 billion in contracts that the Stem Cell Research Institute is likely to grant to white institutions. I have personally been involved in negotiations with a wide range of regulatory bodies and private institutions, including all of the major banks, on supplier diversity issues and have advised the Insurance Commissioner on this matter as part of my duties on the Insurance Department COIN Board.
“Our organization has been active before the California Public Utilities Commission (CPUC). As a result of actions by various minority organizations, AT&T awarded 17% of its contracts to minorities, SBC awarded 23% of its contracts to minorities, Edison awarded 16% and Verizon awarded 15%. In large measure, this is due to the CPUC having set 15% minority contract goals at our request.
“We are concerned that no such goals exist for stem cell research. We are also well aware of the University of California’s embarrassing record of failing to enroll, hire or do business with minority communities. Unfortunately, UC does not, as a deliberate policy in order to prevent criticism of its white-only policies, gather records generally relating to race and ethnicity of its almost $5 billion a year in contracts. However, according to recent data provided to the Greenlining Institute from the office of the General Counsel for the Regents of the U.C., data is available for U.C. Davis. It shows that just 5% of contracts were awarded to minority-owned businesses for the last year reported 2003.
“We urge you to take the following action:
“Request that the Oversight Committee set goals of fifteen to twenty-five percent of contracts for small, minority-owned businesses, including professional services, and that the Committee provide an annual report broken down by race and ethnicity on achievements.
“No contracts of $1 million or more be awarded unless the business or institution, including universities, has a supplier diversity program and discloses its results by race and ethnicity.
“Require the University of California, prior to its submitting any bids for any contracts or services, to submit detailed information by race and ethnicity of all of its contracts, much as the CPUC requires of the utilities.
“Californians, including an overwhelming number of Latinos and other minorities, voted in favor of Prop 71. We also deserve a fair share of all contracts.
“Please be assured that if you have other hearings on this matter, I will be pleased to attend and would be pleased to work with the stem cell research Oversight Committee in achieving equal opportunity for all businesses.”

Semi-Complete Coverage Coming Up on Ortiz Hearing

Later today, we will have semi-complete coverage of the California Legislative hearing into the new state stem cell agency. Look for information from State Sen. Deborah Ortiz, who is chairing the hearing, and Californians Aware, the Center for Genetics and Society, the Greenlining Institute and perhaps more. We expect to post about 3:30 p.m. PST

More Egg Regulation Sought

The Center for Genetics and Society has joined with the Pro-Choice Alliance for Responsible Research to call for increased regulation of the California stem cell agency in connection with the use of women's eggs for research.

The groups plan to testify at Wednesday's California State Senate hearing into the new agency.

One of their recommendations: “Before undertaking multiple egg extraction from healthy women, all data on drugs used in such procedures should be reviewed by a neutral, knowledgeable, and independent oversight body whose sole purpose is to protect the safety and rights of women wishing to provide eggs.”

“If researchers begin experimenting...on a large scale, they will need eggs from many thousands of women. Payment to these women for their eggs, even if it is considered reimbursement, would create an economic inducement for women to put themselves at risk. This would be especially true for poor and young women,” said Marcy Darnovsky , associate director of the Center for Genetics and Society .

You can see the press release here and the full text of a letter from Suzanne Parisian, M.D., a former chief medical officer for the FDA.

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.

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.

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.

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."

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.”

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.”

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.

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.

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."

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.

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.