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."
Tuesday, March 01, 2005
Monday, February 28, 2005
Questions for the Landlord
The RFP for the permanent headquarters of the California stem cell agency admirably attempts to avoid any conflicts of interest with future landlords, but at the same time leaves a substantial ambiguity gap.
According to a CIRM press release, one of the requirements of a lease is a "letter signed certifying that the owner does not have and will not have in the future any ownership interest in any firms or agencies competing for grants to be awarded by the Institute."
The question is: What is ownership? Some folks say owning stock in a company is ownership. However, if the amount is only worth, let's say $10,000, is that ownership? What if it is $1 million? That may be only a fraction of one percent of the value of a company. But it could promise substantial gains if the stock rises.
What about ownership by spouses or minor children? What if the property is owned by a partnership, say 10 persons? Are all 10 required to meet the no-ownership ban?
It is impossible to write rules that cover every possibility, but this one needs a little clarification.
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We welcome comments on CIRM or the failings of this blog. They will be published. Please send them to djensen@californiastemcellreport.com.
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.
----------------
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.”
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.”
His recommendation is contained in a 20-page review of fiscal standards prepared for distribution to the oversight committee at its meeting tomorrow. The review examined procedures at the NIH, the National Science Foundation and the relatively new and small Stem Cell Research Foundation.
Westly notes that despite longstanding standards at the NIH and NSF, both agencies “still periodically encounter problems that raise questions over the use of grant funds by some of the grantees.” He suggests that CIRM use the agencies' standards as a starting point.
Westly's report says CIRM should “clarify audit requirements for (both) the institute and its grantees.”
“The initiative specifies that the institute shall annually commission an independent financial audit of its activities from a certified public accounting firm. However, what constitutes a financial audit could be interpreted differently, from a very limited-scope financial statement audit to a comprehensive financial and compliance audit. In addition, given that the initiative specifies that the Institute shall commission the audit 'of its activities,' it is unclear as to whether the audit would include the activities of the grantees, which, in our opinion, pose a higher risk,” the report says.
“Therefore, if the financial audit does not include the activities of the grantees, the institute should make arrangements for such activities to be audited. One option would be to adopt the federal single audit requirement by having those grantees receiving grant funds in excess of a certain amount arrange for an independent audit. Another option would be to create an audit function within the Institute to perform grant audits. The institute could also directly contract with other audit organizations for such audits.”
Sunday, February 27, 2005
Ethics: From Compensation to Informed Consent
Bio-ethicist Alta Charo will be speaking this week to the California stem cell agency, and the topic will not be "Star Trek," although she is fond enough of the program to mention it on her web site.
Going where no University of Wisconsin law professor has gone before (which is in front of CIRM), Charo expects to discuss possible creation of a stem cell bank by the agency, among other matters. In remarks prepared to be distributed to Oversight Committee members, she said:
“Forming a physical or virtual stem cell bank could be of great value to the community of researchers in California (and indeed, the nation and the world). Facilitating the task of documenting the ethical standards under which lines were derived will help collaborators to work more efficiently, given the variations in national and international research rules in this field. In addition, a cell bank could set standards for the quality of the characterizations and the accompanying medical information associated with the lines.”
Charo's main thrust, in her prepared material, is to raise questions that should be answered as CIRM begins its funding of research. The areas she touched on include human subject protection, informed consent, patient privacy, compensation bans and possible establishment of an additional committee.
“While most institutions have the committees required by federal law for currently mandated reviews (including IRBs for human subjects protections; Privacy Boards for HIPAA protections; IBCs for recombinant DNA research; IACUCs for animal research) few have any committee specially created to monitor and coordinate compliance with these mandates by hES cell researchers,” she wrote. “Nor do many have a special committee to register the level of activity at the institution, to offer investigator training in stem cell research ethics, or to serve as a venue for discussion, review or even approval of potentially problematic forms of the research. A key question, then, is whether CIRM wishes to encourage or require institutions to create such committees, or whether it plans to have CIRM provide one centrally for all CIRM-funded research. In the alternative, this question could be left entirely to the discretion of individual institutions, who could set up such committees, designate existing committees to expand their functions to incorporate some of these tasks, or simply do without such added oversight entirely.”
Charo is Elizabeth S. Wilson - Bascom Professor of Law and Bioethics at the University of Wisconsin at Madison, where she is on the faculty of the Law School and the Medical School's Department of Medical History and Bioethics.
Her web site shows a long and distinguished career and demonstrates a certain lightness. On it, she reports that she is fond of Star Trek, poker, roller coasters, old movies and salsa music and includes links to appropriate sites in those areas.
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.”
“Ninety percent of the criticisms are from people who opposed Prop. 71. Now, there is 10 percent of the criticisms that are very healthy viewpoints. And even with those people who oppose Prop. 71, when we go through nine months of public hearings for permanent standards, we will try and address their concerns to make sure they understand all the different regulations that will protect individuals. ... What the public doesn't understand is there's layer after layer of protection. There's federal law, there's state law, there's hospital regulations ... and institutional review board standards. ... In addition, the National Academy of Sciences on approximately April 1, [plans] to put out model standards for the nation, that we would hope to look at and adopt with some enhancements, to really create a very high-level model for the whole country to follow in stem cell research standards.”
Friday, February 25, 2005
Restrictions Eased in HQ RFP
Contra Costa Times readers may have been the only ones in the state to receive the latest news this morning on plans for the permanent headquarters of the California stem cell agency.
Reporter Sandy Kleffman said Daly City, San Diego and Sacramento were among cities “monitoring” the committee meeting on the specifications for the headquarters, which are scheduled to be issued formally on Feb. 28 with a decision by May.
She also wrote:
“As they debated what to include in their list of preferences, committee members sought to avoid the perception that they had pre-selected a site by making requirements too restrictive.
“The initial draft of documents said preference would be given to locations within 45 minutes of four or more leading universities or research hospitals. It also said weight would be given to sites with a nearby pool of at least 25,000 biomedical professionals, as long as the majority of them were not engaged in the production of medical devices.
“But some people complained that this left too many cities out of the running. So committee members decided to simply give preference to cities near major universities and a biomedical talent pool, without specifying numbers.
“Preference will also be given to cities that can provide space for major stem cell conferences and that have ready access to Sacramento by plane, train or car. Institute leaders said their staff members will communicate frequently with state officials and they want to minimize travel time.”
The draft RFP also contained a provision that the HQ should be within two hours of the state Capitol. A technical reading of that would bar San Diego, given that it takes more than two hours from the time you enter the San Diego airport to arrive in Sacramento because of the need to clear security. It is not known whether that provision remains in the RFP.
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.
The selection process is up for review and approval on Feb. 28 by a CIRM committee. The agenda is here, along with the presidential criteria.
Thursday, February 24, 2005
Working Groups Akin to Legislative Committees
The governmental accountability group, Californians Aware, is bolstering efforts to maintain the openness of the working groups of the California stem cell agency.
The group, based in Sacramento, said that the stem cell groups are akin to committees in the state Legislature. If they operate in private, there would be virtually no way for the public or interested parties to make their views known.
Terry Francke, general counsel for the group, said in a letter to the Oversight Committee of the agency:
"Put simply, just as a Legislature without open committees is unthinkable, an ICOC relying on secret Working Groups won’t work in a manner people can trust. California (to say nothing of the rest of the nation and world, who have a substantial interest in what the Institute does) has no shortage of highly seasoned experts and advocates on the scientific, medical, legal, ethical and financial standards whose development and policing are assigned to the Working Groups in the first instance. To give these sources of experience a chance to comment on these standards only at the last minute before the ICOC, and in ignorance of what issues and options had been deliberated, modified, avoided or discarded in the process would be folly, and an insult to tradition."
Francke also noted that it is necessary to observe committee proceedings if economic disclosure laws are to have real meaning. "Knowing what wealth considerations might influence a lawmaker without being able to detect that influence is no better than being able to detect interest biases but not knowing what the interests are," he said.
Francke's letter did not argue that functions of the committees such as peer review of grant recipients and detailed initial discussions of individual grant proposals be conducted in public sessions. He said that California law provides for closed sessions for such matters when they come before state and local legislative bodies.
The Californians Aware letter was written in support of some of the objectives of the Halpern-Lee petition, which seeks to compel the Oversight Committee to hold hearings on rules for open meetings, conflicts of interest and other matters.
The Oversight Committee next week is scheduled to consider a move to delegate the handling of the petition to its chairman, Robert Klein.
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.
"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.
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.
First came the lawsuits earlier this week, asking the California State Supreme Court to extinguish the agency, although it was approved by 59 percent of California voters. Then came the press release on the Christian Communications Network touting the lawsuits.
It will be only a matter of time until the likes of Rush Limbaugh will seize on the issue. The right is very agile on the Web and will rally forces there as well.
In some ways, it is surprising that it has taken so long.
Wednesday, February 23, 2005
Illegal and Unconstitutional?
A trio of politically conservative groups is asking the California Supreme Court to put the California stem cell agency out of business.
The efforts are being made by Californians for Public Accountability and Ethical Science, People's Advocate and the National Tax Limitation Foundation.
The Associated Press story by Paul Elias, which was distributed nationally, says that People's Advocate and the National Tax Limitation Foundation questioned the creation of CIRM because it's not governed exclusively by state government and because the committee that controls the money isn't publicly elected.
The accountability group contends voters did not have the power to create the agency.
That group also alleges that loopholes exist in the Prop. 71 that would permit the funding of " 'test tube babies,' or even adult human beings, for body parts, companionship or a permanent worker class of subhuman beings (a la, Aldous Huxley's Brave New World)” despite its ban on human reproductive cloning.
The fanciful charge was not reported in the accounts we saw, but is certain to be circulated widely in anti-stem cell circles, regardless of whether it is well-founded.
Julie Buckner, a spokeswoman for CIRM, says the complaints about the legality of Prop. 71 are "strikingly similar" to a lawsuit the tobacco industry filed and lost after the 1998 approval of Proposition 10. Proposition 10 authorized a 50-cent increase in the cigarette tax to pay for smoking prevention and early childhood education programs.
David Llewellyn, a Citrus Heights attorney, prepared the filing on behalf of the accountability group and Joni Eareckson Tada, who is identified as an advocate for the rights of the disabled.
“The people cannot legislate away their inalienable right to be governed only by state officials who have absolute, uncompromised loyalty to the public interest,” the petition for a writ of mandate argues.
Llewellyn contends that Prop. 71 is a “a qualitative revision of the state Constitution, which cannot lawfully be accomplished through the initiative process.”
Stories were also written by Laura Mecoy in The Sacramento Bee and Teri Somers in the San Diego Union Tribune.
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."
"A desperate injection of stem cells and hope" and "Outside the U.S., businesses run with unproved stem cell therapies."
Monday, February 21, 2005
Hearing the Drumbeat
It seems odd that the California stem cell agency cannot move effectively to temper the criticism that dogs it concerning conflicts of interest and accountability.
The issues have plagued CIRM since December when its first meeting was dominated by charges of impropriety and potential impropriety. Since then, Chairman Robert Klein and other oversight committee members have repeatedly stressed their intention to apply the highest standards to the conduct of the agency.
Yet the issues persist, attracting unfavorable attention in the media nationally as well is in California. The stain is not yet permanent. But the longer it exists, the harder it will be to purge. That would be a serious burden for an infant agency that must appear to be acting with propriety in order to succeed.
The latest flap surfaced last week as the result of a petition filed by Berkeley attorney Charles Halpern and Philip Lee, former chancellor of UC San Francisco. Some of the specifics in the petition are old, some new. The two, working with the Center for Genetics and Society, are seeking a 30-minute hearing before the oversight committee to air their concerns. Unless something changes, they are not likely to achieve that goal, based on the agenda for the March 1 meeting. Klein has an item on it to have the board directly delegate their petition to him.
It may be that some of CIRM’s critics simply want to cripple the agency. Halpern and Lee, however, say in their petition, "We want to see the program launched by Prop. 71 succeed."
They also say, "We stress that our focus on the conflict of interest issue is not intended to impugn the integrity of any members of the ICOC or its leaders. We believe that strict adherence to conflict of interest principles is necessary to maintain public confidence in the objectives and processes of the CIRM, and to assure that there can be no doubt that each decision of the ICOC is made exclusively on its merits."
One can understand that the drumbeat of criticism rankles Klein and others, who feel their integrity has been questioned. But testiness and defensiveness can be put aside. The appearance of brushing off ethical considerations should be avoided if CIRM is fulfill Klein’s own very high expecations.
There are a number of ways to handle issues raised by Halpern and others. One would be to create a special panel of perhaps 10 oversight committee members to hold a daylong hearing (no vote to be taken) into the issues. Ask all witnesses to submit all of their material in advance and mount it on the CIRM web site prior to the meeting. Thus the reading of lengthy statements could be avoided. Instead questions could be asked and answered, both on the part of the public and board members, which is more productive than endless readings.
It would be politic to have half of the committee consist of oversight members who are seen to have the greatest potential conflicts.
Holding such a hearing would help to eliminate allegations that critics have not been heard. It would provide useful input in developing rules on ethics and openness. And it would help the agency move forward more rapidly and successfully on its intended path.
--------------------
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.
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.
--------------------
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.
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.
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."
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.
With that in mind, we want all of the avid and not-so-avid readers of the California Stem Cell Report to know that it is our policy to correct mistakes as quickly and completely as possible.
Nothing is to be gained by making misstatements. Failing to correct them is even a greater disservice to readers. But stuff happens, as they say, particularly in the world of blogging where writers work without editors. So if you see something that is incorrect on this site, please send a note to djensen@californiastemcellreport.com. Our appreciation will know no bounds.
Friday, February 18, 2005
Bee and Chron alone?
The Sacramento Bee and the San Francisco Chronicle may be the only major California newspapers to have written their own stories on the latest move to compel the California stem cell agency to deal more directly with accountability and conflict-of-interest allegations.
Carl Hall wrote in the Chronicle: “A decorated veteran of the country's public health battles -- dating back to the founding of the Medicare system -- is taking aim at the California stem cell program.
“Dr. Philip R. Lee, a consulting professor at Stanford University and former UCSF chancellor who helped craft national health policies for the Johnson and Clinton administrations, signed onto a legal petition to protest some of the early activities of the California Institute for Regenerative Medicine.”
Laura Mecoy of The Bee said, “Using a new tactic, critics of the state's stem cell program have filed a petition seeking more open meetings, salary caps and tighter conflict-of-interest rules for paid executives.”
We will have more on this move during the next few days.
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.
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.
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.
Site Search Committee -- Thursday Feb. 24, 2 p.m., UC San Francisco. Subjects include the RFP for a permanent site location. Details here.
Presidential Search Subcommittee – Monday Feb. 28, 9 a.m., UC San Francisco. Subjects include the executive search process timeline proposed by Spencer Stuart. Details here.
A Few “Clicks” for CIRMers
USA Today carried a story on the California stem cell agency that has an interesting quote from Chairman Robert Klein.
Reporter Elizabeth Weise wrote:
"I'm verging on complete mental exhaustion trying to get it right," says Klein, looking as if he hasn't gotten a full night's sleep in weeks. "I'm averaging 10 to 12 phone calls a day that have to get taken care of immediately, and then a few more to make sure the process keeps moving along."
Klein has a mammoth task before him. It is virtually unprecedented in state history: the almost overnight creation of a new multi-billion dollar state agency exploring the frontiers of science, medicine and theology. Daunting for anyone.
Some folks get a little impatient with the process and progress, partly because of the high expectations that Klein himself has created. But we should remember and appreciate the human aspect of this endeavor. A bunch of folks are working madly to meet the needs of the agency and the people of California. They will never be able to make everybody happy. They are also bound to feel unappreciated as well from time to time. And that includes Mr. Klein.
In the sailing world, we have regular “nets,” times when scores of people gather via ham or VHF radio each day to exchange information. Sometimes people are recognized for their efforts by listeners who all click their microphones at the same time. So here are a few clicks for the CIRMers, including Robert Klein.
Reporter Elizabeth Weise wrote:
"I'm verging on complete mental exhaustion trying to get it right," says Klein, looking as if he hasn't gotten a full night's sleep in weeks. "I'm averaging 10 to 12 phone calls a day that have to get taken care of immediately, and then a few more to make sure the process keeps moving along."
Klein has a mammoth task before him. It is virtually unprecedented in state history: the almost overnight creation of a new multi-billion dollar state agency exploring the frontiers of science, medicine and theology. Daunting for anyone.
Some folks get a little impatient with the process and progress, partly because of the high expectations that Klein himself has created. But we should remember and appreciate the human aspect of this endeavor. A bunch of folks are working madly to meet the needs of the agency and the people of California. They will never be able to make everybody happy. They are also bound to feel unappreciated as well from time to time. And that includes Mr. Klein.
In the sailing world, we have regular “nets,” times when scores of people gather via ham or VHF radio each day to exchange information. Sometimes people are recognized for their efforts by listeners who all click their microphones at the same time. So here are a few clicks for the CIRMers, including Robert Klein.
Thursday, February 17, 2005
Web-casting for CIRM Proceedings?
The California stem cell agency is considering Web-casting the meetings of its oversight committee to make the operations of the group more accessible to the public and media.
The topic was brought up by Jeff Sheehy, of UC San Francisco and a member of the oversight committee, at the group's February meeting. He said that many members of the public and the media cannot attend the committee meetings for a variety of reasons.
Committee Chairman Robert Klein indicated he would ask an information technology consultant to look into Web-casting as part of a broader review of technology issues.
This is a step in the right direction, but nothing stands in the way of doing right now. It shouldn't take more than a week to set it up for the March meeting of the committee. Any number of firms could handle a one-time shot, and it would provide useful information for evaluating longterm procedures.
Given the nature of the agency, a wise firm would offer to post the proceedings without charge.
The affairs of the California Institute of Regenerative Medicine are of global interest, not only at academic institutions but at private companies and government agencies. Web-casting would help provide the details that are of critical to scientists and policy makers.
Making the proceedings available live on the Web additionally would do much to fulfill the committee's pledges of openness. It would make the stem cell agency accessible to those bright, young scientists it wants to encourage and attract to California.
And it would help counter the negative images now flitting across the country as a result of The Washington Post's page one piece on Sunday (see item on this blog on Feb. 14). Doing that sooner rather than later would seem to be in the stem cell agency's best interests.
Sheehy's very brief comments begin on page 214 of the transcript of the meeting.
The topic was brought up by Jeff Sheehy, of UC San Francisco and a member of the oversight committee, at the group's February meeting. He said that many members of the public and the media cannot attend the committee meetings for a variety of reasons.
Committee Chairman Robert Klein indicated he would ask an information technology consultant to look into Web-casting as part of a broader review of technology issues.
This is a step in the right direction, but nothing stands in the way of doing right now. It shouldn't take more than a week to set it up for the March meeting of the committee. Any number of firms could handle a one-time shot, and it would provide useful information for evaluating longterm procedures.
Given the nature of the agency, a wise firm would offer to post the proceedings without charge.
The affairs of the California Institute of Regenerative Medicine are of global interest, not only at academic institutions but at private companies and government agencies. Web-casting would help provide the details that are of critical to scientists and policy makers.
Making the proceedings available live on the Web additionally would do much to fulfill the committee's pledges of openness. It would make the stem cell agency accessible to those bright, young scientists it wants to encourage and attract to California.
And it would help counter the negative images now flitting across the country as a result of The Washington Post's page one piece on Sunday (see item on this blog on Feb. 14). Doing that sooner rather than later would seem to be in the stem cell agency's best interests.
Sheehy's very brief comments begin on page 214 of the transcript of the meeting.
Tuesday, February 15, 2005
Correction
On Feb. 13, we wrote incorrectly that a document having to do with grant proposals was no longer available on the CIRM web site. That item is available on the web site but was obscured during a web redesign, and we could not find it. Here is one link to it and here is another that was produced by using the search engine on the site.
HQ RFP by End of Month
The final RFP for the permanent headquarters of the California stem cell agency is expected to be issued by the end of the month. Fiona Hutton, a spokeswoman for the California Institute for Regenerative Medicine, says a press release will be issued when the proposal is ready.
The site search committee has scheduled a meeting to consider the matter on Feb. 24 at 2 p.m. at UC San Francisco. The agenda is here.
Meanwhile, California newsies are busy writing more about the subject and the lobbying efforts that are underway. Most of the stories are in the weekly business newspapers around the state, which specialize in development and leasing news.
Daniel Levine of the San Francisco Business Times reported that AKT Development in Sacramento plans to offer 10 years free rent with views of the Sacramento River and the Capitol. He also noted that Wareham Development, CIRM's interim landlord in Emeryville, is definitely going to bid for the permanent site. Wareham touts its connection to Chiron, which was co-founded by Ed Poenhoet, vice chairman of the CIRM oversight committee.(See previous items in this blog on Feb. 6 and Feb. 8)
Katherine Conrad of the East Bay Business Times has perhaps the most fulsome account of Wareham and its approach.
The HQ has even entered the mayor's race in the city of Los Angeles with the incumbent offering free space downtown.
Jim Wunderman, president and CEO of the Bay Area Council, and Sean Randolph, president and CEO of the Bay Area Economic Forum, plumped for a Bay Area location for the site in an op-ed piece in the Silicon Valley Business Journal.
The site search committee has scheduled a meeting to consider the matter on Feb. 24 at 2 p.m. at UC San Francisco. The agenda is here.
Meanwhile, California newsies are busy writing more about the subject and the lobbying efforts that are underway. Most of the stories are in the weekly business newspapers around the state, which specialize in development and leasing news.
Daniel Levine of the San Francisco Business Times reported that AKT Development in Sacramento plans to offer 10 years free rent with views of the Sacramento River and the Capitol. He also noted that Wareham Development, CIRM's interim landlord in Emeryville, is definitely going to bid for the permanent site. Wareham touts its connection to Chiron, which was co-founded by Ed Poenhoet, vice chairman of the CIRM oversight committee.(See previous items in this blog on Feb. 6 and Feb. 8)
Katherine Conrad of the East Bay Business Times has perhaps the most fulsome account of Wareham and its approach.
The HQ has even entered the mayor's race in the city of Los Angeles with the incumbent offering free space downtown.
Jim Wunderman, president and CEO of the Bay Area Council, and Sean Randolph, president and CEO of the Bay Area Economic Forum, plumped for a Bay Area location for the site in an op-ed piece in the Silicon Valley Business Journal.
Hearing Changed to March 9
The legislative hearing on the California stem cell agency has been changed from March 2 to March 9 at 1:30 p.m. in room 4203 of the Capitol. See item Feb. 7 on this blog for more details.
Monday, February 14, 2005
Bedtime Reading Posted at CIRM
For those of you who have trouble getting to sleep, the California stem cell agency has posted its first cure.
Go to the site and download the 218 page transcript of its February oversight committee meeting. If that isn't enough, try 266 pages from January. For the capper, dig into 99 pages from the accountability working group meeting.
But seriously, this an excellent step in the right direction in keeping the agency open to interested parties. It also serves the agency well. More information on the Web means fewer direct calls to harried staffers and demonstrates its commitment to openness.
Good work, CIRMers.
Go to the site and download the 218 page transcript of its February oversight committee meeting. If that isn't enough, try 266 pages from January. For the capper, dig into 99 pages from the accountability working group meeting.
But seriously, this an excellent step in the right direction in keeping the agency open to interested parties. It also serves the agency well. More information on the Web means fewer direct calls to harried staffers and demonstrates its commitment to openness.
Good work, CIRMers.
Whither Melissa?
Melissa Carpenter of Canada's Robart Research Institute may have taken herself out of the running for the post of interim head of California's stem cell agency. Then again she may be right at the top of the list.
The London Free Press is reporting, in an article by John Miner, that she is leaving the institute to work for an unnamed biotech firm in San Diego to research the use of stem cells in the treatment of diabetes.
While she may be eager to return to California and start work in her new position, it certainly would not hurt her or her new firm for the good doctor to take a brief leave before actually reporting in San Diego. Spending six months setting up CIRM would provide invaluable experience and contacts for future endeavors.
The London Free Press is reporting, in an article by John Miner, that she is leaving the institute to work for an unnamed biotech firm in San Diego to research the use of stem cells in the treatment of diabetes.
While she may be eager to return to California and start work in her new position, it certainly would not hurt her or her new firm for the good doctor to take a brief leave before actually reporting in San Diego. Spending six months setting up CIRM would provide invaluable experience and contacts for future endeavors.
Sunday, February 13, 2005
The Washington Post Strikes
Reporter Ariana Eunjung Cha of the Washington Post weighed in on Sunday with a piece on California's stem cell agency that is likely to help shape the national view of the fledgling insitute.
And that is not good news for the agency.
The Page One headline said “Struggling Science Experiment.” The third paragraph of the article said:
“The initiative has been tainted by accusations that those who pushed hardest for the money stand to benefit from it the most. Advocates question the pell-mell pace organizers have set to get the program up and running; they worry that in their haste, program leaders are taking too many shortcuts, leaving the initiative vulnerable to being taken advantage of by private profiteers and unscrupulous scientists.”
The piece contained little that has not already been reported. But it reaches an important audience of opinion and policy makers. It will also likely set the tone for other national coverage of the agency as other media read the piece.
And that is not good news for the agency.
The Page One headline said “Struggling Science Experiment.” The third paragraph of the article said:
“The initiative has been tainted by accusations that those who pushed hardest for the money stand to benefit from it the most. Advocates question the pell-mell pace organizers have set to get the program up and running; they worry that in their haste, program leaders are taking too many shortcuts, leaving the initiative vulnerable to being taken advantage of by private profiteers and unscrupulous scientists.”
The piece contained little that has not already been reported. But it reaches an important audience of opinion and policy makers. It will also likely set the tone for other national coverage of the agency as other media read the piece.
About $90 million in First Round Grants
California's stem cell agency is preparing to ladle out something in the neighborhood of $90 million in grants in the first cycle of what some call the stem cell gold rush.
Based on “conceptual blueprints” prepared by CIRM, most of the money –roughly $60 million – will go for grants for “centers of excellence.” Another $20 million or so will aim at creating 'intellectual infrastructure.” Up to $10 million is slated for seed grants.
Barred from consideration during the first cycle of grants are large “individual initiated” proposals as well as proposals from commercial firms and proposals for clinical research. Those apparently will be considered after standards for research, conflict of interest and intellectual property are developed.
The outline of the first cycle of grants is “evolutionary,” according CIRM documents. What that seems to means is that all of this information is subject to change without notice and probably is already out-of-date. The timetable for proposals is not available but CIRM officials have said they want to distribute some cash by May.
In fact, the document on which this article is based is no longer available on the CIRM site. It was removed with no explanation posted on the web site nor was it replaced with more recent information.
That said, here is a summary of the various categories:
Centers of excellence: Annual grants of $5-$7 million each, including costs of leasing. Bidders are expected to be consortium of institutions or a team of scientists at a single institution.
Intellectual infrastructure: Grants aimed at training post-docs, medical students, young faculty “to populate the field of stem cell research with excellent scientists and physicians.”
Seed grants: Individual grants of about $50,000 to $150,000 for new or established scientists so they can “gather preliminary data on a new idea.” These grants are also aimed at “scientists established in a field other than stem cell research who have promising ideas that, subject to documentation, would justify refocusing their efforts in the stem cell research field.”
If you are interested in receiving the full document, which is a one-page PDF file, please email us at djensen@californiastemcellreport.com.
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Comments on CIRM or the failings of this blog are welcome and will be published. Please send them to djensen@californiastemcellreport.com.
Based on “conceptual blueprints” prepared by CIRM, most of the money –roughly $60 million – will go for grants for “centers of excellence.” Another $20 million or so will aim at creating 'intellectual infrastructure.” Up to $10 million is slated for seed grants.
Barred from consideration during the first cycle of grants are large “individual initiated” proposals as well as proposals from commercial firms and proposals for clinical research. Those apparently will be considered after standards for research, conflict of interest and intellectual property are developed.
The outline of the first cycle of grants is “evolutionary,” according CIRM documents. What that seems to means is that all of this information is subject to change without notice and probably is already out-of-date. The timetable for proposals is not available but CIRM officials have said they want to distribute some cash by May.
In fact, the document on which this article is based is no longer available on the CIRM site. It was removed with no explanation posted on the web site nor was it replaced with more recent information.
That said, here is a summary of the various categories:
Centers of excellence: Annual grants of $5-$7 million each, including costs of leasing. Bidders are expected to be consortium of institutions or a team of scientists at a single institution.
Intellectual infrastructure: Grants aimed at training post-docs, medical students, young faculty “to populate the field of stem cell research with excellent scientists and physicians.”
Seed grants: Individual grants of about $50,000 to $150,000 for new or established scientists so they can “gather preliminary data on a new idea.” These grants are also aimed at “scientists established in a field other than stem cell research who have promising ideas that, subject to documentation, would justify refocusing their efforts in the stem cell research field.”
If you are interested in receiving the full document, which is a one-page PDF file, please email us at djensen@californiastemcellreport.com.
---------
Comments on CIRM or the failings of this blog are welcome and will be published. Please send them to djensen@californiastemcellreport.com.
Facilities Meeting on Feb. 22
The search subcommittee of the Scientific and Medical Research Facilities Working Group Sunday scheduled a meeting for Feb. 22 to discuss criteria and processes for selecting members of the full facilities working group.
Also on the agenda is “consideration of cost effectiveness for facilities grants including discussion of prototype development, renovation of existing facilities and specialized facilities.”
The meeting will be at 9 a.m. at UCLA with teleconference locations at UC Davis, Stanford and the Burnham Institute in La Jolla.
The full agenda should be available at the CIRM website.
Also on the agenda is “consideration of cost effectiveness for facilities grants including discussion of prototype development, renovation of existing facilities and specialized facilities.”
The meeting will be at 9 a.m. at UCLA with teleconference locations at UC Davis, Stanford and the Burnham Institute in La Jolla.
The full agenda should be available at the CIRM website.
Finding a Focus
Stuart Spencer, the San Francisco search firm hired to help fill “one of the highest-profile leadership positions now being advertised in the scientific world,” may have a little trouble focusing on the task.
That's because it is also bidding to become the search firm to find the new CEO at Hewlett-Packard.
To give you some idea of the magnitude of difference, the Wall Street Journal last week had several front page stories (more inside) on the HP vacancy. It had none on the California stem cell agency.
The HP position is also likely to pay something in the range of $5 to $10 million annually. The CIRM position is more like $500,000 or less. Stuart Spencer is being paid $150,000, plus expenses, for its job with the state of California. No word on the size of the HP contract.
That's because it is also bidding to become the search firm to find the new CEO at Hewlett-Packard.
To give you some idea of the magnitude of difference, the Wall Street Journal last week had several front page stories (more inside) on the HP vacancy. It had none on the California stem cell agency.
The HP position is also likely to pay something in the range of $5 to $10 million annually. The CIRM position is more like $500,000 or less. Stuart Spencer is being paid $150,000, plus expenses, for its job with the state of California. No word on the size of the HP contract.
Stuart Spencer reports that it has 300 "consultants" who are available to find execs. It also reports that it "conducted nearly 4,000 assignments" last year.
Writer Carl Hall of the San Francisco Chronicle came up with the description of the CIRM chief's position as the “one of the highest profile....”
Just Call Him Scoop
Reporter Carl Hall of the San Francisco Chronicle seems to have beaten his rivals at other California newspapers with a story that Zach W. Hall of the University of Southern California is the leading candidate to become the interim executive of the California stem cell agency.
Hall – the potential big cheese for CIRM, not the writer – is currently the medical research dean at USC. The Chronicle's report describes him as “a veteran neuroscientist, medical-school administrator and biotech entrepreneur.”
Also in the running is cell biologist Melissa Carpenter, a principal investigator at the Robarts Research Institute in London, Ontario.
According to writer Hall, Dean Hall was one four scientific founders and the former chief executive of a Massachusetts company called EnVivo Pharmaceuticals. It was created in 2001 to develop new treatments for diseases of the nervous system.
“The company apparently has no projects involving stem cell research,” Hall reported.
The Chronicle also quoted colleagues of the 67-year-old Hall as describing him as a “gifted administrator.”
“Hall was recruited to California from Harvard in 1976 to join the faculty at UCSF, where he was head of neurobiology and chair of the physiology department. From 1994 to 1997, Hall took a leave from UCSF to serve as director of the National Institute of Neurological Disorders and Stroke, a part of the NIH.
“He returned to full-time duty at UCSF and became vice chancellor for research in 1998. Hall helped direct the gargantuan planning effort that went into UCSF's Mission Bay campus, a 43-acre project along San Francisco's southern bay shore. Mission Bay is one of several possible locations around the state for the new stem cell institute's headquarters,” the Chronicle said.
Writer Hall said that the dean is not expected to be selected as the permanent chief of the agency. It was not clear whether there was any relationship between the writer and the dean but unlikely.
Hall – the potential big cheese for CIRM, not the writer – is currently the medical research dean at USC. The Chronicle's report describes him as “a veteran neuroscientist, medical-school administrator and biotech entrepreneur.”
Also in the running is cell biologist Melissa Carpenter, a principal investigator at the Robarts Research Institute in London, Ontario.
According to writer Hall, Dean Hall was one four scientific founders and the former chief executive of a Massachusetts company called EnVivo Pharmaceuticals. It was created in 2001 to develop new treatments for diseases of the nervous system.
“The company apparently has no projects involving stem cell research,” Hall reported.
The Chronicle also quoted colleagues of the 67-year-old Hall as describing him as a “gifted administrator.”
“Hall was recruited to California from Harvard in 1976 to join the faculty at UCSF, where he was head of neurobiology and chair of the physiology department. From 1994 to 1997, Hall took a leave from UCSF to serve as director of the National Institute of Neurological Disorders and Stroke, a part of the NIH.
“He returned to full-time duty at UCSF and became vice chancellor for research in 1998. Hall helped direct the gargantuan planning effort that went into UCSF's Mission Bay campus, a 43-acre project along San Francisco's southern bay shore. Mission Bay is one of several possible locations around the state for the new stem cell institute's headquarters,” the Chronicle said.
Writer Hall said that the dean is not expected to be selected as the permanent chief of the agency. It was not clear whether there was any relationship between the writer and the dean but unlikely.
Thursday, February 10, 2005
Tough CIRM Application Disappears
California's stem cell agency has dropped its probing and perhaps invasive job application form from its web site. Instead the institute now posts a standard state employment application document.
The disappearance of the application form came after the California Stem Cell Report on Feb. 1 wrote about the nature of the inquiries on the original application. The change on the CIRM web site also occurred after the California Stem Cell Report began to query the appointing authorities, from the governor to UC chancellors, about whether they had asked appointees to the Oversight Committee the same questions posed in the application for CIRM employees.
The original application form vanished from the CIRM web site by Feb. 9, the last time it was checked by the California Stem Cell Report, and was replaced by a plain vanilla form.
In response to an inquiry about the change, Fiona Hutton, a spokeswoman for CIRM, said, “As was discussed at the last ICOC meeting, the initial employment application was taken directly from the Governor's web site. In terms of getting up to speed quickly, the Institute staff utilized the Governor's existing application as a foundation to start from. The application has been edited as you pointed out.”
The Feb. 1 item on this web site about the now retired job application said in part:
“California's stem cell agency wants to know. Can somebody that you associated with impugn your character, even unfairly? That is one of the very personal questions that must be answered by job applicants to the California Institute for Regenerative Medicine.
“Might your income or investments present an “appearance” of a conflict of interest? Yes or no. Have you written a letter-to-the-editor on “any particular controversial issue?” Yes or no. Is there anything in your background that could embarrass us? Yes or no. Please explain is the request if you respond in the affirmative.”
Our conclusion was that these questions should be asked, in one form or another, by CIRM of all applicants, ranging from clerks to president. The reason being is that genuinely big money is at stake. And there is a history of successful temptation in other big money venues.
The questions on the application form, however, raised other questions about whether appointees to the Oversight Committee faced the same interrogation. So we addressed the appropriate appointing powers. But some statewide constitutional officers, including the governor, seem terribly timid about making themselves available to public inquiries via email. The email addresses of some of their press offices, which, in theory, would be the most accessible, are virtually impossible to find. If a reporter is part of the Capitoil press contingent, those email addresses are undoubtedly accessible. But if you are a reporter for the Imperial Valley Press, for example, forget about ever sending an email to the governor's press office. You may never find the address.
An exception was the website and office of the state treasurer, Phil Angelides, whose public spokesman, Dan Newman, responded quickly and professionally. The UC campuses were also generally accessible.
Based on the responses to our query, it appears that none of the appointees to the Oversight Committee have been asked the type of questions that CIRM wanted to ask its potential employees with two possible exceptions, including perhaps the governor.
Here is the question that we posed on Feb. 2 to all the appointing entities: “Were the appointees to the oversight committee asked the questions contained in the application prior to their appointment? (We) plan to publish an item on your response next week. Please send it to us by 3 p.m. PST Wednesday Feb. 9. The other appointing powers for the committee are also being asked the same question.”
Here are the responses by office.
Governor – Did not respond. The application form that Hutton mentioned could not be downloaded at the time of this writing, which may have something to do with our Internet link.
Lt. Gov.-- “The Lieutenant Governor did not ask the questions on that list of prospective CIRM candidates and no one provided him with a list of recommended questions. We took the step of providing each potential candidate with a Form 700 (state economic disclosure form) so they could see just what they would need to declare. We also advised them that they should be prepared to recuse themselves from any votes concerning matters that might pose a potential conflict. Dr. Richard Murphy suggested in the interview that subcommittees that screen grant applications should be staffed by people from other states to minimize conflicts. The Lieutenant Governor liked that idea,” said Stephen Green, a spokesman for Bustamante.
Treasurer – “We had those we were considering fill out our standard State Treasurer's Office appointee application, so, no, we didn't use the application that the CIRM is using,” Dan Newman said. The treasurer's application (sent by email) is close to what CIRM had, which is not unexpected considering the sensitive nature of the billions of dollars of investments handled by the treasuer's office. The questions on the treasurer's form include whether the applicant has been involved in an “appearance” of a conflict of interest, has written letters-to-the-editor on controversial subjects and whether the applicant has anything in his or her background that could reflect negatively on the treasurer and more along those lines. (Send us an email if you would like to us to send you the entire application, which is not available online.)
Controller --.Did not respond.
Senate President Pro Tem John Burton, now out office – Could not be reached.
Assembly Speaker – Did not respond.
UC Chancellors – Lisa Lapin, assistant vice chancellor at UC Davis answered first. Her response then became the response of all the chancellors. (For newsgatherers, that is one of the perils of asking questions with a long lead time for response. Everybody's response is easily coordinated, ducks can be aligned, candidness is lost and so forth. But if they aren't given a long lead time for a response, our public information officers often yip like wounded coyotes.)
Here is the UC answer:
“Because the five ICOC members appointed from the UC medical schools are, by virtue of their UC positions, (public officials under the Political Reform Act, they had already filled out state disclosure forms listing their economic interests (Form 700), even before their appointment to the ICOC. Before announcing our appointments, UC reviewed with each member the interests listed on their form and discussed with them the importance of avoiding conflicts of interest and of recusing themselves from decisions in which they have a personal financial interest, as required by law.
“The CIRM employment application form was just recently posted to CIRM's website. It is not something we had seen prior to the appointment of the University'ss ICC representatives. UC Davis Medical School Dean and Vice Chancellor of our health system, Claire Pomeroy, our appointee, has not subsequently been asked by Institute staff to respond to the questions listed on the CIRM application form.”
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Your comments on CIRM or the failings of this blog are welcome and will be posted. Please send them to djensen@californiastemcellreport.blogspot.com.
The disappearance of the application form came after the California Stem Cell Report on Feb. 1 wrote about the nature of the inquiries on the original application. The change on the CIRM web site also occurred after the California Stem Cell Report began to query the appointing authorities, from the governor to UC chancellors, about whether they had asked appointees to the Oversight Committee the same questions posed in the application for CIRM employees.
The original application form vanished from the CIRM web site by Feb. 9, the last time it was checked by the California Stem Cell Report, and was replaced by a plain vanilla form.
In response to an inquiry about the change, Fiona Hutton, a spokeswoman for CIRM, said, “As was discussed at the last ICOC meeting, the initial employment application was taken directly from the Governor's web site. In terms of getting up to speed quickly, the Institute staff utilized the Governor's existing application as a foundation to start from. The application has been edited as you pointed out.”
The Feb. 1 item on this web site about the now retired job application said in part:
“California's stem cell agency wants to know. Can somebody that you associated with impugn your character, even unfairly? That is one of the very personal questions that must be answered by job applicants to the California Institute for Regenerative Medicine.
“Might your income or investments present an “appearance” of a conflict of interest? Yes or no. Have you written a letter-to-the-editor on “any particular controversial issue?” Yes or no. Is there anything in your background that could embarrass us? Yes or no. Please explain is the request if you respond in the affirmative.”
Our conclusion was that these questions should be asked, in one form or another, by CIRM of all applicants, ranging from clerks to president. The reason being is that genuinely big money is at stake. And there is a history of successful temptation in other big money venues.
The questions on the application form, however, raised other questions about whether appointees to the Oversight Committee faced the same interrogation. So we addressed the appropriate appointing powers. But some statewide constitutional officers, including the governor, seem terribly timid about making themselves available to public inquiries via email. The email addresses of some of their press offices, which, in theory, would be the most accessible, are virtually impossible to find. If a reporter is part of the Capitoil press contingent, those email addresses are undoubtedly accessible. But if you are a reporter for the Imperial Valley Press, for example, forget about ever sending an email to the governor's press office. You may never find the address.
An exception was the website and office of the state treasurer, Phil Angelides, whose public spokesman, Dan Newman, responded quickly and professionally. The UC campuses were also generally accessible.
Based on the responses to our query, it appears that none of the appointees to the Oversight Committee have been asked the type of questions that CIRM wanted to ask its potential employees with two possible exceptions, including perhaps the governor.
Here is the question that we posed on Feb. 2 to all the appointing entities: “Were the appointees to the oversight committee asked the questions contained in the application prior to their appointment? (We) plan to publish an item on your response next week. Please send it to us by 3 p.m. PST Wednesday Feb. 9. The other appointing powers for the committee are also being asked the same question.”
Here are the responses by office.
Governor – Did not respond. The application form that Hutton mentioned could not be downloaded at the time of this writing, which may have something to do with our Internet link.
Lt. Gov.-- “The Lieutenant Governor did not ask the questions on that list of prospective CIRM candidates and no one provided him with a list of recommended questions. We took the step of providing each potential candidate with a Form 700 (state economic disclosure form) so they could see just what they would need to declare. We also advised them that they should be prepared to recuse themselves from any votes concerning matters that might pose a potential conflict. Dr. Richard Murphy suggested in the interview that subcommittees that screen grant applications should be staffed by people from other states to minimize conflicts. The Lieutenant Governor liked that idea,” said Stephen Green, a spokesman for Bustamante.
Treasurer – “We had those we were considering fill out our standard State Treasurer's Office appointee application, so, no, we didn't use the application that the CIRM is using,” Dan Newman said. The treasurer's application (sent by email) is close to what CIRM had, which is not unexpected considering the sensitive nature of the billions of dollars of investments handled by the treasuer's office. The questions on the treasurer's form include whether the applicant has been involved in an “appearance” of a conflict of interest, has written letters-to-the-editor on controversial subjects and whether the applicant has anything in his or her background that could reflect negatively on the treasurer and more along those lines. (Send us an email if you would like to us to send you the entire application, which is not available online.)
Controller --.Did not respond.
Senate President Pro Tem John Burton, now out office – Could not be reached.
Assembly Speaker – Did not respond.
UC Chancellors – Lisa Lapin, assistant vice chancellor at UC Davis answered first. Her response then became the response of all the chancellors. (For newsgatherers, that is one of the perils of asking questions with a long lead time for response. Everybody's response is easily coordinated, ducks can be aligned, candidness is lost and so forth. But if they aren't given a long lead time for a response, our public information officers often yip like wounded coyotes.)
Here is the UC answer:
“Because the five ICOC members appointed from the UC medical schools are, by virtue of their UC positions, (public officials under the Political Reform Act, they had already filled out state disclosure forms listing their economic interests (Form 700), even before their appointment to the ICOC. Before announcing our appointments, UC reviewed with each member the interests listed on their form and discussed with them the importance of avoiding conflicts of interest and of recusing themselves from decisions in which they have a personal financial interest, as required by law.
“The CIRM employment application form was just recently posted to CIRM's website. It is not something we had seen prior to the appointment of the University'ss ICC representatives. UC Davis Medical School Dean and Vice Chancellor of our health system, Claire Pomeroy, our appointee, has not subsequently been asked by Institute staff to respond to the questions listed on the CIRM application form.”
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Your comments on CIRM or the failings of this blog are welcome and will be posted. Please send them to djensen@californiastemcellreport.blogspot.com.
Tuesday, February 08, 2005
Reaction to Chiron-Wareham Link Piece
The California Stem Cell Report asked both CIRM and Wareham Development for responses to the item posted earlier this week concerning links that Wareham say its has with Chiron, one of whose founders is vice chairman of the oversight committee.
Here is the comment from Tim Gallen, a spokesman for Wareham:
“Wareham has been one of Chiron’s landlords since the company was founded. So, in the past, Chiron leased research space from Wareham and still does -- along with 27 other research companies in Emeryville, Berkeley and Richmond. But, as 'financial links' go, we both know that a common lease is hardly the kind of relationship I believe Mr. Klein was addressing in his remarks to San Diego journalist, Terri Somers.”
The agency has not replied to our inquiry. However, it posted on its web site either late Monday, Feb. 7, or today, Feb. 8, a press release dated Feb. 3. The item said:
“The lessor(Wareham) does not have any interest in firms or agencies competing for grants to be awarded by the Institute. The Institute staff worked through the State Department of General Services (“DGS”) and the State Controller’s Office to audit available office space and ultimately select the Horton Street location(in Emeryville).”
Here is the comment from Tim Gallen, a spokesman for Wareham:
“Wareham has been one of Chiron’s landlords since the company was founded. So, in the past, Chiron leased research space from Wareham and still does -- along with 27 other research companies in Emeryville, Berkeley and Richmond. But, as 'financial links' go, we both know that a common lease is hardly the kind of relationship I believe Mr. Klein was addressing in his remarks to San Diego journalist, Terri Somers.”
The agency has not replied to our inquiry. However, it posted on its web site either late Monday, Feb. 7, or today, Feb. 8, a press release dated Feb. 3. The item said:
“The lessor(Wareham) does not have any interest in firms or agencies competing for grants to be awarded by the Institute. The Institute staff worked through the State Department of General Services (“DGS”) and the State Controller’s Office to audit available office space and ultimately select the Horton Street location(in Emeryville).”
CIRM Web Site Developments
CIRM's web site is changing. The information is about the same as two days ago, but it does have a press release dated Feb. 3 that was not there on the afternoon of Feb. 7.
The press release contains information that was widely reported in the media on Feb. 4 although with a few more details, depending on what you read.
The changes in the site seem to make it conform to the format and graphics of most California state web sites. It now includes a mug shot of Arnold and a link to his page, for example.
The next step, we hope, is to provide background information packets well in advance of meetings as is the practice of most local and state government bodies in California.
The press release contains information that was widely reported in the media on Feb. 4 although with a few more details, depending on what you read.
The changes in the site seem to make it conform to the format and graphics of most California state web sites. It now includes a mug shot of Arnold and a link to his page, for example.
The next step, we hope, is to provide background information packets well in advance of meetings as is the practice of most local and state government bodies in California.
Monday, February 07, 2005
Legislative hearings scheduled for March 2
California State Sen. Deborah Ortiz today scheduled a hearing to look into the California stem cell agency, covering everything from conflicts-of-interest to intellectual property rights.
The three-way "informational hearing" will include members from both the Senate and Assembly Health Committee as well as the newly created Senate Subcommittee on Stem Cell Research Oversight.
The hearing will be held on March 2, from 1:30 – 5:00, in Room 4203 of the State Capitol.
The Democratic senator's office said topics of the hearing will include:
"Policies and standards to ensure diversity in Prop. 71 appointments, hiring, and contracting;
"Treatment of intellectual property rights arising from research funded by the ICOC(the oversight committee);
"Application of open meeting laws and standards to ICOC working groups and subcommittee;
"Adoption of conflict of interest and economic disclosure standards for members of the ICOC and its working groups;
"Development of standards to protect research subjects and donors; and
"Prop. 71 auditing and public accountability functions."
Persons interested in testifying should contact the senator's aide at the following email address: Peter.Hansel@sen.ca.gov.
The three-way "informational hearing" will include members from both the Senate and Assembly Health Committee as well as the newly created Senate Subcommittee on Stem Cell Research Oversight.
The hearing will be held on March 2, from 1:30 – 5:00, in Room 4203 of the State Capitol.
The Democratic senator's office said topics of the hearing will include:
"Policies and standards to ensure diversity in Prop. 71 appointments, hiring, and contracting;
"Treatment of intellectual property rights arising from research funded by the ICOC(the oversight committee);
"Application of open meeting laws and standards to ICOC working groups and subcommittee;
"Adoption of conflict of interest and economic disclosure standards for members of the ICOC and its working groups;
"Development of standards to protect research subjects and donors; and
"Prop. 71 auditing and public accountability functions."
Persons interested in testifying should contact the senator's aide at the following email address: Peter.Hansel@sen.ca.gov.
The Bee Stings CIRM
“Rife with questionable entanglements” is how The Sacramento Bee describes California's new stem cell agency.
The language was contained in an unsigned editorial in The Bee on Sunday. That means it represents the institutional opinion of that newspaper's ownership.
The Bee's editorial was strong. It remarked on the new standards at the NIH and said California's agency should learn from the controversies that have unsettled the NIH.
The Bee was not happy with the conduct of CIRM so far. It said that at the meeting of the oversight committee last week, “comittee member Leon Thal asked if members themselves could apply for grants. To everyone's amazement, the oversight committee started to entertain this idea. After journalists started raising questions, committee members quickly re-adjourned and put the kibosh on granting grants to themselves.”
“If the committee wants to retain a semblance of credibility, it needs to set ethics standards that are as strong, if not stronger, than those of the NIH,” The Bee declared.
One thing to keep in mind about newspaper editorials is that surveys show that they are read by a small segment of readers, as opposed to the percentage who read the front page. That said, politicians and other community leaders often think newspaper editorials are meaningful.
(My apologies to The Bee and the readers of this blog for the headline on this item. I could not help myself.)
The language was contained in an unsigned editorial in The Bee on Sunday. That means it represents the institutional opinion of that newspaper's ownership.
The Bee's editorial was strong. It remarked on the new standards at the NIH and said California's agency should learn from the controversies that have unsettled the NIH.
The Bee was not happy with the conduct of CIRM so far. It said that at the meeting of the oversight committee last week, “comittee member Leon Thal asked if members themselves could apply for grants. To everyone's amazement, the oversight committee started to entertain this idea. After journalists started raising questions, committee members quickly re-adjourned and put the kibosh on granting grants to themselves.”
“If the committee wants to retain a semblance of credibility, it needs to set ethics standards that are as strong, if not stronger, than those of the NIH,” The Bee declared.
One thing to keep in mind about newspaper editorials is that surveys show that they are read by a small segment of readers, as opposed to the percentage who read the front page. That said, politicians and other community leaders often think newspaper editorials are meaningful.
(My apologies to The Bee and the readers of this blog for the headline on this item. I could not help myself.)
Sunday, February 06, 2005
CIRM Landlord Says It Linked to Chiron
The California stem cell agency's new landlord, Wareham Development, says it has links to Chiron Corp., one of whose founders is vice chairman of the state stem cell agency, Ed Penhoet.
The relationship to Chiron is touted on Wareham's web site and was discovered as part of research by the California Stem Cell Report.
Wareham's web site, on its "about" page, says, “Our history of fostering the newer, smaller, incubating company is exemplified in our relationship with Chiron Corporation, which began in the 1980s when we became one of Chiron's first landlords.”
Robert Klein, chairman of the California Institute for Regenerative Medicine, said last week, however, that Wareham “is not connected to him, to any committee member or to any entity that might benefit from the stem cell grant money,” according to a report by Terri Somers in the San Diego Union Tribune.
Penhoet sits on Chiron's board and owns more than $1 million in Chiron stock, according to filings with the state.
While the statement on Wareham's site appears to indicate there is some sort of current financial link between it and Chiron, that could be marketing rhetoric based on past landlord-tenant relationships.
Nonetheless it seems likely that top management at Chiron, which is based in Emeryville, and Wareham, located across the bay in San Rafael, have an ongoing connection, given the Internet display of their history.
CIRM announced its decision last week to move into a Wareham site this coming Friday in Emeryville in the East Bay area of San Francisco. For the first seven months, CIRM will pay no rent on the lease of 7,416 square feet of office space. After that it will pay market rates on a month-to-month basis, according to a report by Judy Silber in the Contra Costa Times. Another report in the San Diego Union Tribune says, however, the rates will be below market. Furniture and building improvements will be also provided free, according to the San Diego Transcript (no link available).
The decision to house the agency temporarily in Emeryville does not mean that Wareham or Emeryville will have an edge in the tussle for the permanent headquarters, according to CIRM officials.
However, inertia can always play a factor in relocation decisions. It is time-consuming and expensive to move. Beyond that, Wareham has a track record with state agencies and should be comfortable in dealing with CIRM officials and with the state's legal requirements regarding office space.
The suitors for CIRM are waging an energetic courtship. San Diego is considering a $5 million pool to help with the “moving, housing and other costs” to bring stem cell super stars to its area, according to a report by Somers in the San Diego Union Tribune. Increasing the density of top researchers presumably would make the area more attractive as a headquarters location as well.
Something along those lines is likely to be offered by other competitors, given the extreme housing costs in California, which are among the highest in the nation. In fact, San Diego was recently ranked as one of the most least affordable places in the nation to buy a home. The Bay Area is not much better.
Klein and other CIRM directors have made it clear they are expecting major incentives from cities seeking the headquarters, which will house up to 50 employees. Likely to play a significant role as well are the preferences of the top candidates for the CEO position at CIRM (see the previous item on this blog called "CEO Reality" Jan. 27). Selection of that person is also underway as well.
So far the following areas have been mentioned in the media as potential locations for the headquarters: San Francisco, San Diego, San Jose, Los Angeles, Sacramento, the Central Valley and Riverside County.
The agency is working rapidly to decide on the location. It had plans to issue an RFP this week and make a selection next month.
Cities are keeping the details of their bids confidential lest they tip off competitors. But some information has emerged.
Here is a look at what has surfaced.
San Francisco – The package focuses on Townsend Center, a building at 650 Townsend St. owned by Bernard Osher, according to a report by Daniel S. Levine in the San Francisco Business Times. He said Osher contributed $250,000 to the Yes on Prop. 71 campaign. California State Sens. Carole Migden, Don Perata and Jackie Speier and U.S. Sen. Diane Feinstein support either the Bay Area or San Francisco, according to Levine.
San Diego – Few details of the San Diego proposal have emerged except for the $5 million fund plan.
Sacramento – The city is offering 15,000 square feet of space at no charge for a certain period in a building on the Sacramento River in Old Sacramento, close to the state Capitol, according to a report by Dale Kasler in The Sacramento Bee. Discounted rates would apply thereafter. The building at One Capitol Mall is controlled by the Tsakopoulos family, which is very well connected in Democratic politics.
Little has been reported about bids by other areas.
-------
Comments on CIRM and the failings of this blog are welcome. Please send them to djensen@californiastemcellreport.blogspot.com.
The relationship to Chiron is touted on Wareham's web site and was discovered as part of research by the California Stem Cell Report.
Wareham's web site, on its "about" page, says, “Our history of fostering the newer, smaller, incubating company is exemplified in our relationship with Chiron Corporation, which began in the 1980s when we became one of Chiron's first landlords.”
Robert Klein, chairman of the California Institute for Regenerative Medicine, said last week, however, that Wareham “is not connected to him, to any committee member or to any entity that might benefit from the stem cell grant money,” according to a report by Terri Somers in the San Diego Union Tribune.
Penhoet sits on Chiron's board and owns more than $1 million in Chiron stock, according to filings with the state.
While the statement on Wareham's site appears to indicate there is some sort of current financial link between it and Chiron, that could be marketing rhetoric based on past landlord-tenant relationships.
Nonetheless it seems likely that top management at Chiron, which is based in Emeryville, and Wareham, located across the bay in San Rafael, have an ongoing connection, given the Internet display of their history.
CIRM announced its decision last week to move into a Wareham site this coming Friday in Emeryville in the East Bay area of San Francisco. For the first seven months, CIRM will pay no rent on the lease of 7,416 square feet of office space. After that it will pay market rates on a month-to-month basis, according to a report by Judy Silber in the Contra Costa Times. Another report in the San Diego Union Tribune says, however, the rates will be below market. Furniture and building improvements will be also provided free, according to the San Diego Transcript (no link available).
The decision to house the agency temporarily in Emeryville does not mean that Wareham or Emeryville will have an edge in the tussle for the permanent headquarters, according to CIRM officials.
However, inertia can always play a factor in relocation decisions. It is time-consuming and expensive to move. Beyond that, Wareham has a track record with state agencies and should be comfortable in dealing with CIRM officials and with the state's legal requirements regarding office space.
The suitors for CIRM are waging an energetic courtship. San Diego is considering a $5 million pool to help with the “moving, housing and other costs” to bring stem cell super stars to its area, according to a report by Somers in the San Diego Union Tribune. Increasing the density of top researchers presumably would make the area more attractive as a headquarters location as well.
Something along those lines is likely to be offered by other competitors, given the extreme housing costs in California, which are among the highest in the nation. In fact, San Diego was recently ranked as one of the most least affordable places in the nation to buy a home. The Bay Area is not much better.
Klein and other CIRM directors have made it clear they are expecting major incentives from cities seeking the headquarters, which will house up to 50 employees. Likely to play a significant role as well are the preferences of the top candidates for the CEO position at CIRM (see the previous item on this blog called "CEO Reality" Jan. 27). Selection of that person is also underway as well.
So far the following areas have been mentioned in the media as potential locations for the headquarters: San Francisco, San Diego, San Jose, Los Angeles, Sacramento, the Central Valley and Riverside County.
The agency is working rapidly to decide on the location. It had plans to issue an RFP this week and make a selection next month.
Cities are keeping the details of their bids confidential lest they tip off competitors. But some information has emerged.
Here is a look at what has surfaced.
San Francisco – The package focuses on Townsend Center, a building at 650 Townsend St. owned by Bernard Osher, according to a report by Daniel S. Levine in the San Francisco Business Times. He said Osher contributed $250,000 to the Yes on Prop. 71 campaign. California State Sens. Carole Migden, Don Perata and Jackie Speier and U.S. Sen. Diane Feinstein support either the Bay Area or San Francisco, according to Levine.
San Diego – Few details of the San Diego proposal have emerged except for the $5 million fund plan.
Sacramento – The city is offering 15,000 square feet of space at no charge for a certain period in a building on the Sacramento River in Old Sacramento, close to the state Capitol, according to a report by Dale Kasler in The Sacramento Bee. Discounted rates would apply thereafter. The building at One Capitol Mall is controlled by the Tsakopoulos family, which is very well connected in Democratic politics.
Little has been reported about bids by other areas.
-------
Comments on CIRM and the failings of this blog are welcome. Please send them to djensen@californiastemcellreport.blogspot.com.
Saturday, February 05, 2005
Coming Up
The contest for the HQ location of the California stem cell agency is on a fast track with a host of competitors offering big incentives. Look for a roundup on the situation in Monday's California Stem Cell Report.
Readers Write
Nuns and Ham-handed Questions
This comment comes from Jeff Raimundo, longtime political consultant in Sacramento:
"I have to disagree with you in part about your take on "bags of swag."
"Clearly, (Robert) Klein himself would have trouble getting past CIRM's
"'Might your income or investments present an 'appearance' of a
conflict of interest? Yes or no. Is there anything in your background
that could embarrass us? Yes or no.' -- Ya think!?
"If Klein can answer those questions in the negative, what applicant is going to think any differently? Those are the kinds of questions I think ARE entirely appropriate for later interviews, for the reasons you outlined. At the front end, however, they are imprecise, ham-handed and hypocritical.
"CIRM has great promise and probably should be excused for early
glitches on its maiden voyage. But such a public display of
holier-than-thou attitude by bosses who can't pass the test themselves
sets CIRM up as a too-easy target for critics."
The following comes from retired historian Tom Hall of Berkeley:
"The Bags of Swag is a nice piece that raises all kinds of interesting
questions about the realism of public expectations. Abe Lincoln would
never been elected president if he had to submit to such a test prior to
being nominated. The only ones who could pass the test are cloistered
nuns, and I'm not so sure they could."
Send your comments on CIRM and the failings of this blog to djensen@californiastemcellreport.com
This comment comes from Jeff Raimundo, longtime political consultant in Sacramento:
"I have to disagree with you in part about your take on "bags of swag."
"Clearly, (Robert) Klein himself would have trouble getting past CIRM's
"'Might your income or investments present an 'appearance' of a
conflict of interest? Yes or no. Is there anything in your background
that could embarrass us? Yes or no.' -- Ya think!?
"If Klein can answer those questions in the negative, what applicant is going to think any differently? Those are the kinds of questions I think ARE entirely appropriate for later interviews, for the reasons you outlined. At the front end, however, they are imprecise, ham-handed and hypocritical.
"CIRM has great promise and probably should be excused for early
glitches on its maiden voyage. But such a public display of
holier-than-thou attitude by bosses who can't pass the test themselves
sets CIRM up as a too-easy target for critics."
The following comes from retired historian Tom Hall of Berkeley:
"The Bags of Swag is a nice piece that raises all kinds of interesting
questions about the realism of public expectations. Abe Lincoln would
never been elected president if he had to submit to such a test prior to
being nominated. The only ones who could pass the test are cloistered
nuns, and I'm not so sure they could."
Send your comments on CIRM and the failings of this blog to djensen@californiastemcellreport.com
Thursday, February 03, 2005
Cannonade Leveled at CIRM
The Center for Genetics-and-Society has launched a sweeping broadside at the California stem cell agency. We haven't had a chance to read it all yet but will have more on it later. It is sure to be an item of interest at the Oversight Committee meeting today. Below is a quick summary from the center. You can see all that the center has to say by going to its website. The center's charges allege:
"Inadequate conflict of interest rules for members of the ICOC and the three working groups established by Proposition 71.
"Unjustified exemptions of the three working groups from state rules on open meetings, conflict of interest, and public reporting.
"Troubling overlaps and conflicts among CIRM, the California Research and Cures Coalition, the debts of the "Yes on 71" campaign, ICOC Chair Robert Klein's business operations, and his personal finances."
"Inadequate conflict of interest rules for members of the ICOC and the three working groups established by Proposition 71.
"Unjustified exemptions of the three working groups from state rules on open meetings, conflict of interest, and public reporting.
"Troubling overlaps and conflicts among CIRM, the California Research and Cures Coalition, the debts of the "Yes on 71" campaign, ICOC Chair Robert Klein's business operations, and his personal finances."
CIRM Sayings: Cowboys and Hell to Pay
What are people saying about the California stem cell agency? Here are a few quotes that seem of current interest. If you have any offerings for this intermittent feature on this blog, please send them to djensen@californiastemcellreport.com.
"If the money is spent and there aren't effective treatments that result, I think there will be hell to pay."Joan Samuelson, CIRM oversight committee member, as quoted on MSNBC Jan. 21, 2005
"They (other states) are putting proposals together to retain people. It may cost more because all of a sudden these scientists are being competed for." Arnold Kriegstein, director of UCSF stem-cell research program, as quoted in the San Francisco Business Times Jan. 28, 2005, article by Daniel S. Levine
"We're going to have to do the science. We can't have cowboys out there doing things, especially when it comes to patients." Dr. David Kessler, oversight committee member, dean of the UCSF medical school and former head of the FDA, as quoted Jan. 21, 2005, MSBNC.
“I pledge to serve the interests of California citizens, its patients and its taxpayers. In doing so, I am committed to transparency in process, public oversight and accountability, and the highest ethical and medical standards possible.” Robert Klein, chairman of the oversight committee, in a statement issued Dec. 13, 2004.
"If the money is spent and there aren't effective treatments that result, I think there will be hell to pay."Joan Samuelson, CIRM oversight committee member, as quoted on MSNBC Jan. 21, 2005
"They (other states) are putting proposals together to retain people. It may cost more because all of a sudden these scientists are being competed for." Arnold Kriegstein, director of UCSF stem-cell research program, as quoted in the San Francisco Business Times Jan. 28, 2005, article by Daniel S. Levine
"We're going to have to do the science. We can't have cowboys out there doing things, especially when it comes to patients." Dr. David Kessler, oversight committee member, dean of the UCSF medical school and former head of the FDA, as quoted Jan. 21, 2005, MSBNC.
“I pledge to serve the interests of California citizens, its patients and its taxpayers. In doing so, I am committed to transparency in process, public oversight and accountability, and the highest ethical and medical standards possible.” Robert Klein, chairman of the oversight committee, in a statement issued Dec. 13, 2004.
Tuesday, February 01, 2005
Prop. 71 Campaign Spends nearly $35 million
The Los Angeles Times has reported on last fall's campaign spending. Here is what reporter Dan Morain had to say about the California stem cell measure:
"Promoters of Proposition 71, which authorized the state to sell $3 billion in bonds to fund stem cell research, spent $34.7 million.The Yes On 71 campaign reported a debt of almost $6.5 million.
"In the final days before the November election, venture capitalist John Doerr and his wife, Ann Doerr, lent the campaign a combined $1 million, as did Robert Klein, who since has been named chairman of the board overseeing the initiative's implementation.
"Altogether, Klein, a Palo Alto developer, gave or lent the campaign $2.1 million and spent an additional $200,000 on other state campaigns, placing him among the biggest individual spenders on state politics in 2004.
"A campaign spokeswoman said backers of the stem cell initiative intend to raise money to pay off the Doerrs, various vendors who worked for the campaign and possibly Klein — raising the possibility that entities and individuals seeking stem cell research money could make donations that would help Klein recoup some of the $1 million loan."
"Promoters of Proposition 71, which authorized the state to sell $3 billion in bonds to fund stem cell research, spent $34.7 million.The Yes On 71 campaign reported a debt of almost $6.5 million.
"In the final days before the November election, venture capitalist John Doerr and his wife, Ann Doerr, lent the campaign a combined $1 million, as did Robert Klein, who since has been named chairman of the board overseeing the initiative's implementation.
"Altogether, Klein, a Palo Alto developer, gave or lent the campaign $2.1 million and spent an additional $200,000 on other state campaigns, placing him among the biggest individual spenders on state politics in 2004.
"A campaign spokeswoman said backers of the stem cell initiative intend to raise money to pay off the Doerrs, various vendors who worked for the campaign and possibly Klein — raising the possibility that entities and individuals seeking stem cell research money could make donations that would help Klein recoup some of the $1 million loan."
Hiring and Appearances, Integrity and Bags of Swag
California's stem cell agency wants to know. Can somebody that you associated with impugn your character, even unfairly? That is one of the very personal questions that must be answered by job applicants to the California Institute for Regenerative Medicine.
Might your income or investments present an “appearance” of a conflict of interest? Yes or no. Have you written a letter-to-the-editor on “any particular controversial issue?” Yes or no. Is there anything in your background that could embarrass us? Yes or no.
Please explain is the request if you respond in the affirmative.
The inquiries are part of the job application form on CIRM's web site. All are also on the same form for applicants for position of interim CEO of the agency.
The questions seem to be testimony to how seriously CIRM takes the concerns about conflicts of interest, accountability and integrity. They are tough questions, ones that would make many of us uncomfortable. They go way beyond inquiries that this writer dealt with in 1975 when he worked for the governor of California, who also happened to be the sponsor of the state's first and only major economic disclosure law. But that was before Enron and Worldcom, Irangate and Monicagate.
Some might regard the inquiries on the CIRM application as a personal invasion. Nonetheless, they are certainly legitimate questions to be asked of aspirants for top positions at the agency, which is likely to be subjected to excruciatingly close scrutiny by its foes. If you are doing the hiring for such jobs, you need to know the very worst about the people you are considering. One recent spectacular failure to do so came in the Bush administration with the former police commissioner from New York.
On the other hand, one must ask whether such questions discourage good candidates? The answer? Yes, they do. It is currently a major problem and an unfortunate reality that pervades all of public life. But, if you have bones in the closet, you or your agency's enemies are going to drag them into scandalous public view.
Should these employment questions apply as well to lower level employees, such as clerks? I am sad to say, yes. It is a terrible imposition to ask a $25,000-a-year or so employee to face such inquiries. But there is ample history of low level employees leaking sensitive information when properly primed by those seeking the information.
Little doubt exists that some not-so-ethical private sector folks are likely to tempt both the big and little cheeses at CIRM with large bags of swag for information. Extremely valuable intellectual property will be housed at the stem cell agency, including trade secrets and confidential research. The stakes are huge. CIRM will be giving away $300 million a year. But that is nothing compared to what the ultimate profits might be on a successful stem cell venture.
The questions on the application are a good first step at ensuring CIRM's integrity. The new agency is already under fire concerning conflicts of interest, an issue that CIRM will have to live with because it will never go away, given the nature of the law that created it.
That said, putting the questions on the application is not enough. The written responses must be buttressed by probing interviews with applicants by several persons. All too often, the formalities of applications become overwhelmed by a boss who wants a particular person, often with good reason.
One might also ask whether members of the oversight committee faced identical questions prior to their appointments. It is doubtful. You could argue that nearly all of them come from positions with high public visibility and have publicly known and respected track records. Thus they are safe appointments. However, that is what President Bush also thought about a certain police commissioner.
As for you readers out there, we would like to know whether you would answer these questions. If not, why not? Please send your replies to djensen@californiastemcellreport.blogspot.com. We will publish at least portions of the responses.
Here are some additional samples of the actual questions from the application form, which can be found at this site. Look for it at the very bottom of the page.
“Do you own real property, personal property, financial holdings or receive income from any source which might present a potential conflict of interest or appearance of conflict of interest with your requested appointment?
“Have you been publicly identified, in person or by organizational members, with a particularly controversial national, state or local issue?
“Have you ever submitted oral or written views to any government authority or the news media, on any particular controversial issue other than in an official government capacity?
“Have you ever had any association with any person or group or business venture which could be used, even unfairly, to impugn or question your character and qualifications for the requested appointment?
“Do you know anyone who might take any steps, overtly or covertly, to oppose your appointment?
“Is there anything in your background which if made known to the general public through your appointment would cause an embarrassment to you and/or the administration?”
Might your income or investments present an “appearance” of a conflict of interest? Yes or no. Have you written a letter-to-the-editor on “any particular controversial issue?” Yes or no. Is there anything in your background that could embarrass us? Yes or no.
Please explain is the request if you respond in the affirmative.
The inquiries are part of the job application form on CIRM's web site. All are also on the same form for applicants for position of interim CEO of the agency.
The questions seem to be testimony to how seriously CIRM takes the concerns about conflicts of interest, accountability and integrity. They are tough questions, ones that would make many of us uncomfortable. They go way beyond inquiries that this writer dealt with in 1975 when he worked for the governor of California, who also happened to be the sponsor of the state's first and only major economic disclosure law. But that was before Enron and Worldcom, Irangate and Monicagate.
Some might regard the inquiries on the CIRM application as a personal invasion. Nonetheless, they are certainly legitimate questions to be asked of aspirants for top positions at the agency, which is likely to be subjected to excruciatingly close scrutiny by its foes. If you are doing the hiring for such jobs, you need to know the very worst about the people you are considering. One recent spectacular failure to do so came in the Bush administration with the former police commissioner from New York.
On the other hand, one must ask whether such questions discourage good candidates? The answer? Yes, they do. It is currently a major problem and an unfortunate reality that pervades all of public life. But, if you have bones in the closet, you or your agency's enemies are going to drag them into scandalous public view.
Should these employment questions apply as well to lower level employees, such as clerks? I am sad to say, yes. It is a terrible imposition to ask a $25,000-a-year or so employee to face such inquiries. But there is ample history of low level employees leaking sensitive information when properly primed by those seeking the information.
Little doubt exists that some not-so-ethical private sector folks are likely to tempt both the big and little cheeses at CIRM with large bags of swag for information. Extremely valuable intellectual property will be housed at the stem cell agency, including trade secrets and confidential research. The stakes are huge. CIRM will be giving away $300 million a year. But that is nothing compared to what the ultimate profits might be on a successful stem cell venture.
The questions on the application are a good first step at ensuring CIRM's integrity. The new agency is already under fire concerning conflicts of interest, an issue that CIRM will have to live with because it will never go away, given the nature of the law that created it.
That said, putting the questions on the application is not enough. The written responses must be buttressed by probing interviews with applicants by several persons. All too often, the formalities of applications become overwhelmed by a boss who wants a particular person, often with good reason.
One might also ask whether members of the oversight committee faced identical questions prior to their appointments. It is doubtful. You could argue that nearly all of them come from positions with high public visibility and have publicly known and respected track records. Thus they are safe appointments. However, that is what President Bush also thought about a certain police commissioner.
As for you readers out there, we would like to know whether you would answer these questions. If not, why not? Please send your replies to djensen@californiastemcellreport.blogspot.com. We will publish at least portions of the responses.
Here are some additional samples of the actual questions from the application form, which can be found at this site. Look for it at the very bottom of the page.
“Do you own real property, personal property, financial holdings or receive income from any source which might present a potential conflict of interest or appearance of conflict of interest with your requested appointment?
“Have you been publicly identified, in person or by organizational members, with a particularly controversial national, state or local issue?
“Have you ever submitted oral or written views to any government authority or the news media, on any particular controversial issue other than in an official government capacity?
“Have you ever had any association with any person or group or business venture which could be used, even unfairly, to impugn or question your character and qualifications for the requested appointment?
“Do you know anyone who might take any steps, overtly or covertly, to oppose your appointment?
“Is there anything in your background which if made known to the general public through your appointment would cause an embarrassment to you and/or the administration?”
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