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.
Monday, February 28, 2005
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.
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Comments on the conduct of CIRM or the failings of this blog are welcome and will be published. Please send them to djensen@californiastemcellreport.com.
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.
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