The blog.bioethics.net is warning of the peril posed by "over-eager salesmen" of stem cell cures, citing an article by a California researcher as opening the door for critics.
Written by the editors of the American Journal of Bioethics, the blog said:
"Today, dozens of children and others who argue - like us - for stem cell research are held up as potential recipients of embryonic stem cell-derived therapy, as though the big worry is that they will not receive their embryo pills next year and will suffer as a result. You don't have to have a long memory to see how dangerous these views can be. Just think back to gene therapy, and the clamor of folks to enroll in early, non-therapeutic trials because of the perceived magic of anything genetic. The very idea of 'gene therapy research' is an oxymoron, if you think about it, as was argued by Nancy King and others.
"Well, in California the arguments in favor of stem cell research are often a big more, um, dramatic than other places, and as a consequence the infractions of the 'do not promise therapies to subjects who will not be getting them yet' rule are more problematic. And it doesn't get worse than this one, by A Scientist In Irvine (Peter J. Bryant), who writes the San Francisco Chronicle to let us know that among the victims of unenlightened stem cell research are the soldiers in Iraq, who won't get their stem cell therapies and will die as a result. It isn't that the argument is wrong, and it certainly isn't that the argument isn't creative, it's that the argument is premature - and in some ways the point to make about stem cell research is that it will transform medicine entirely, including producing therapies that one day will not require the use of embryos, therapies that could never have been produced without the use of this research. Yes that will one day help soldiers. But the promulgation of this 'get it now or else' thing just makes it easier for the opponents of stem cell research to paint stem cell researchers as over-eager salesmen of therapeutic misconception."
For more on this subject, see the "reality check" item below.
Sunday, June 12, 2005
Check Out World Stem Cell Map
We have added some new links to this blog and restored some of the old ones that were lost when we reformatted. The links are annotated as well. A couple of nifty ones are the maps of stem cell research and the world stem cell map. If you have suggestions for additional links, please send them djensen@californiastemcellreport.com or just click on "comment" below.
Saturday, June 11, 2005
Reality Check on a "Recipe for Trouble"
A Harvard stem cell researcher has weighed in with a reminder about the tedious nature of scientific research, especially regarding stem cells.
It stands in contrast to the contentions of officials from the California stem cell agency that their enterprise is a life-and-death matter. Certainly it is important to get on with stem cell research. But the time line on development of stem cell therapies is years, perhaps decades. And then there is the old saw about slowing down so you can go faster.
This is not to demean or diminish the needs of those living with diseases that may be alleviated with stem cell therapy.
David A. Shaywitz, an endocrinologist and stem-cell researcher at Harvard University, wrote in an article that appeared in the Washington Post and the San Francisco Chronicle:
"Advocacy groups must ...level with their stakeholders and explain why treatments based on stem cells will take such a long time to materialize."
He added, "At the same time, these organizations must continue to push scientists to work harder and achieve results faster, encouraging investigators to keep in mind the patients in whose name the research is being conducted (and funded)."
Shaywitz addressed California specifically:
"The explicit expectation of rapid clinical progress -- a key component of California's stem-cell initiative, for example -- is a recipe for trouble. If embryonic stem cells are rushed into clinical trials before the solid science has been done, the resulting fiasco could easily doom the entire future of the field."
"The truth is that science -- good science -- can be maddeningly slow," the stem cell researcher said.
It stands in contrast to the contentions of officials from the California stem cell agency that their enterprise is a life-and-death matter. Certainly it is important to get on with stem cell research. But the time line on development of stem cell therapies is years, perhaps decades. And then there is the old saw about slowing down so you can go faster.
This is not to demean or diminish the needs of those living with diseases that may be alleviated with stem cell therapy.
David A. Shaywitz, an endocrinologist and stem-cell researcher at Harvard University, wrote in an article that appeared in the Washington Post and the San Francisco Chronicle:
"Advocacy groups must ...level with their stakeholders and explain why treatments based on stem cells will take such a long time to materialize."
He added, "At the same time, these organizations must continue to push scientists to work harder and achieve results faster, encouraging investigators to keep in mind the patients in whose name the research is being conducted (and funded)."
Shaywitz addressed California specifically:
"The explicit expectation of rapid clinical progress -- a key component of California's stem-cell initiative, for example -- is a recipe for trouble. If embryonic stem cells are rushed into clinical trials before the solid science has been done, the resulting fiasco could easily doom the entire future of the field."
"The truth is that science -- good science -- can be maddeningly slow," the stem cell researcher said.
Friday, June 10, 2005
Special Insights vs. Possible Special Interests
The building blocks are slipping into place. The California stem cell agency has approved the membership of its facilities working group, including four high-powered "real estate specialists."
The law requires that four members of the group be persons with special knowledge of the real estate industry. What that means is that they have deep roots and ties to the real estate business. Nothing wrong with that. They will bring special insight and knowledge that can be very useful to CIRM. It also means that they may have financial interests that may conflict with the interests of the people of California. Under the current CIRM rules, the people of California will never know what those interests might be. They have to trust the agency and the appointees.
The agency issued a press release on the appointments which said:
“Building research facilities for stem cell research will be a top priority for the CIRM. Current federal restrictions on use of laboratory equipment and space add a special urgency to the mission of the Facilities Working Group,” said Interim President Zach Hall, Ph.D. “This outstanding team of experts will ensure that California stem cell researchers will have high-quality laboratories built in a cost-effective manner.”
"The 11-member Scientific and Medical Research Facilities Working Group makes recommendations to the ICOC that governs on interim and final criteria, requirements and standards for applications for, and the awarding of, grants and loans for buildings, building leases, and capital equipment. The Facilities Working Group will also make recommendations to the ICOC on oversight procedures to ensure grantees’ compliance with the terms of an award."
Here is a look what the agency has to say about the four:
"David Lichtenger is President and Chief Executive Officer of Integrity Office Solutions (IOS), which he founded in 1999. Over the past 20 years, Lichtenger has been personally involved in the planning, design, and construction of over 10 million square feet of projects. IOS project management includes: real estate site and lease evaluation, needs analysis, architectural design, engineering, construction, technology, furniture, A/V, security and relocation services with a guaranteed price and schedule completion date. Projects have included many types of facilities: mission critical data centers, biotechnology and engineering laboratories, clean rooms, medical facilities, offices and manufacturing facilities. IOS serves clients across business sectors: technology, medical device, biotechnology, consulting, financial, healthcare, manufacturing, and non-profit. Prior to IOS, Lichtenger was involved in various real estate development projects."
"Edward M. Kashian of Fresno is the CEO and founder of Lance-Kashian & Company, one of the Central Valley’s leading firms in real estate development, asset management and property management. It has served California since 1964, developing regional shopping centers, office complexes, industrial projects and pioneering master-planned corporate communities. Kashian was a partner in the first “power center” built in the country, which still exists in Fresno. Currently he is the managing partner for River Park Properties, developers of River Park Shopping Center, the co-managing partner for Fancher Creek Properties, LLC, a general partner of Kashian Enterprises and the Fresno Historic Chinatown, LLC."
Deborah Hysen is currently Project Director for the California Performance Review, adjunct to the Department of General Services (DGS). She is responsible for start-up and day-to-day functions of this comprehensive review of government established by Governor Arnold Schwarzenegger in 2004. Hysen previously served as Acting Chief Deputy Director at DGS, where she directed the operations of 14 operating divisions and offices providing services to state agencies throughout California, including the Division of the State Architect, Real Estate Services, Office of Public School Construction and Procurement. As a Senior Property Manager at Insignia Commercial Group, she established and implemented policies and procedures that governed the financial performance of the Citibank Building in Los Angeles, a one million square foot Class “A” high-rise. Hysen was previously a property manager for Columbia Savings and Loan, followed by three years as General Manager of Optima Capital Management.
"Albert “Rusty” Doms was CEO and President of his company, Karsten Realty Advisors, from 1972-1994. The company provided real estate investment management services for pension funds and development management services. Before running Karsten, Doms spent six years at Economics Research Associates performing market research and financial feasibility studies for real estate and recreation properties. Mr. Doms has spent several years in service to his community and volunteering for non-profit organizations in various roles, such as Pomona College, the Children’s Bureau, the Los Angeles Building Authority, St. John’s Health Center Foundation, and the Project Advisory Committee for Los Angeles County."
For more details on their professional background see this link.
The law requires that four members of the group be persons with special knowledge of the real estate industry. What that means is that they have deep roots and ties to the real estate business. Nothing wrong with that. They will bring special insight and knowledge that can be very useful to CIRM. It also means that they may have financial interests that may conflict with the interests of the people of California. Under the current CIRM rules, the people of California will never know what those interests might be. They have to trust the agency and the appointees.
The agency issued a press release on the appointments which said:
“Building research facilities for stem cell research will be a top priority for the CIRM. Current federal restrictions on use of laboratory equipment and space add a special urgency to the mission of the Facilities Working Group,” said Interim President Zach Hall, Ph.D. “This outstanding team of experts will ensure that California stem cell researchers will have high-quality laboratories built in a cost-effective manner.”
"The 11-member Scientific and Medical Research Facilities Working Group makes recommendations to the ICOC that governs on interim and final criteria, requirements and standards for applications for, and the awarding of, grants and loans for buildings, building leases, and capital equipment. The Facilities Working Group will also make recommendations to the ICOC on oversight procedures to ensure grantees’ compliance with the terms of an award."
Here is a look what the agency has to say about the four:
"David Lichtenger is President and Chief Executive Officer of Integrity Office Solutions (IOS), which he founded in 1999. Over the past 20 years, Lichtenger has been personally involved in the planning, design, and construction of over 10 million square feet of projects. IOS project management includes: real estate site and lease evaluation, needs analysis, architectural design, engineering, construction, technology, furniture, A/V, security and relocation services with a guaranteed price and schedule completion date. Projects have included many types of facilities: mission critical data centers, biotechnology and engineering laboratories, clean rooms, medical facilities, offices and manufacturing facilities. IOS serves clients across business sectors: technology, medical device, biotechnology, consulting, financial, healthcare, manufacturing, and non-profit. Prior to IOS, Lichtenger was involved in various real estate development projects."
"Edward M. Kashian of Fresno is the CEO and founder of Lance-Kashian & Company, one of the Central Valley’s leading firms in real estate development, asset management and property management. It has served California since 1964, developing regional shopping centers, office complexes, industrial projects and pioneering master-planned corporate communities. Kashian was a partner in the first “power center” built in the country, which still exists in Fresno. Currently he is the managing partner for River Park Properties, developers of River Park Shopping Center, the co-managing partner for Fancher Creek Properties, LLC, a general partner of Kashian Enterprises and the Fresno Historic Chinatown, LLC."
Deborah Hysen is currently Project Director for the California Performance Review, adjunct to the Department of General Services (DGS). She is responsible for start-up and day-to-day functions of this comprehensive review of government established by Governor Arnold Schwarzenegger in 2004. Hysen previously served as Acting Chief Deputy Director at DGS, where she directed the operations of 14 operating divisions and offices providing services to state agencies throughout California, including the Division of the State Architect, Real Estate Services, Office of Public School Construction and Procurement. As a Senior Property Manager at Insignia Commercial Group, she established and implemented policies and procedures that governed the financial performance of the Citibank Building in Los Angeles, a one million square foot Class “A” high-rise. Hysen was previously a property manager for Columbia Savings and Loan, followed by three years as General Manager of Optima Capital Management.
"Albert “Rusty” Doms was CEO and President of his company, Karsten Realty Advisors, from 1972-1994. The company provided real estate investment management services for pension funds and development management services. Before running Karsten, Doms spent six years at Economics Research Associates performing market research and financial feasibility studies for real estate and recreation properties. Mr. Doms has spent several years in service to his community and volunteering for non-profit organizations in various roles, such as Pomona College, the Children’s Bureau, the Los Angeles Building Authority, St. John’s Health Center Foundation, and the Project Advisory Committee for Los Angeles County."
For more details on their professional background see this link.
A Retrospective on Prop. 71 in Houston
If you are looking for a hot time this weekend – stem cell wise – check out Houston.
The Stem Cell Policy and Advocacy Summit gets underway there beginning tomorrow. The Genetics Policy Institute, which is sponsoring the conference, says, "This is a critical time for the advocacy community to develop winning strategies to overcome Draconian legislation and secure adequate funding for research."
South Korea's Woo Suk Hwang will appear. Also scheduled is a look at California post-Prop. 71, including a talk by Jim Battey of the NIH. The political consultant behind the Prop. 71 campaign, Paul Mandabach, and others involved in the campaign will be appearing as well.
You can read more about the conference here.
The Stem Cell Policy and Advocacy Summit gets underway there beginning tomorrow. The Genetics Policy Institute, which is sponsoring the conference, says, "This is a critical time for the advocacy community to develop winning strategies to overcome Draconian legislation and secure adequate funding for research."
South Korea's Woo Suk Hwang will appear. Also scheduled is a look at California post-Prop. 71, including a talk by Jim Battey of the NIH. The political consultant behind the Prop. 71 campaign, Paul Mandabach, and others involved in the campaign will be appearing as well.
You can read more about the conference here.
Wednesday, June 08, 2005
Effort to Shunt SCA13 Fails
The proposed ballot measure to tighten oversight of the California stem cell agency has survived a move to sidetrack it back into a legislative committee. The legislation remains on the Senate floor and could come up for a vote as early as Thursday (June 9).
Sen. Joe Dunn, D-Santa Ana, who has made his legislative bones chewing up energy companies, Wednesday futilely attempted to have the proposal sent to the Judiciary Committee, which he chairs, although the bill has already cleared three legislative committee.
CIRM and Sen. Deborah Ortiz, D-Sacramento, are at loggerheads over her proposed constitutional amendment. Ortiz supported Prop. 71, which created the stem cell agency, but believes the agency should be more accountable and open and ensure that therapies developed with state funds are available to all. The agency believes her measure, SCA13, would cripple the agency and delay cures that could save lives.
One of the key CIRM arguments holds that SCA13 would endanger the issuance of the $3 billion in bonds to fund research. But the state's bond counsel, Orrick, Herrington & Sutcliffe, denies that in a very brief June 7 memo to Ortiz and stem cell chairman Robert Klein.
If you are truly a policy wonk, here are the two salient paragraphs from the memo:
"As drafted, we do not believe the new Section 9(a) (of SCA13) would be an impediment to the issuance of bonds by the State. This is based on the inclusion of the term 'seek to ensure' in the measure, which changes this from a prescriptive rule to a statement of intent or aspiration. We do not believe officials at the ICOC would have a difficulty certifying that they will be seeking the results set out in Section 9(a), although of course we cannot speak for them. We understand the language circulated at the ICOC meeting yesterday (Monday) morning did not include the words 'seek to.' In the absence of those words, we would continue to believe, as stated in a prior Memorandum to (an aide to Ortiz), that such a provision in Article XXXV would be a significant problem for the issuance of bonds.
"Nothing in the proposed Section 9(a) interferes with the ability of the State to issue tax-exempt bonds. As we have stated numerous times in writing and in conversations with you, the final determination of our ability to opine on the tax exemption of any particular issue of State bonds will depend on many factors, including the exact terms of intellectual property conditions which are included with grants or loans made by the CIRM."
Sen. Joe Dunn, D-Santa Ana, who has made his legislative bones chewing up energy companies, Wednesday futilely attempted to have the proposal sent to the Judiciary Committee, which he chairs, although the bill has already cleared three legislative committee.
CIRM and Sen. Deborah Ortiz, D-Sacramento, are at loggerheads over her proposed constitutional amendment. Ortiz supported Prop. 71, which created the stem cell agency, but believes the agency should be more accountable and open and ensure that therapies developed with state funds are available to all. The agency believes her measure, SCA13, would cripple the agency and delay cures that could save lives.
One of the key CIRM arguments holds that SCA13 would endanger the issuance of the $3 billion in bonds to fund research. But the state's bond counsel, Orrick, Herrington & Sutcliffe, denies that in a very brief June 7 memo to Ortiz and stem cell chairman Robert Klein.
If you are truly a policy wonk, here are the two salient paragraphs from the memo:
"As drafted, we do not believe the new Section 9(a) (of SCA13) would be an impediment to the issuance of bonds by the State. This is based on the inclusion of the term 'seek to ensure' in the measure, which changes this from a prescriptive rule to a statement of intent or aspiration. We do not believe officials at the ICOC would have a difficulty certifying that they will be seeking the results set out in Section 9(a), although of course we cannot speak for them. We understand the language circulated at the ICOC meeting yesterday (Monday) morning did not include the words 'seek to.' In the absence of those words, we would continue to believe, as stated in a prior Memorandum to (an aide to Ortiz), that such a provision in Article XXXV would be a significant problem for the issuance of bonds.
"Nothing in the proposed Section 9(a) interferes with the ability of the State to issue tax-exempt bonds. As we have stated numerous times in writing and in conversations with you, the final determination of our ability to opine on the tax exemption of any particular issue of State bonds will depend on many factors, including the exact terms of intellectual property conditions which are included with grants or loans made by the CIRM."
The Bee: State Bond Counsel Says No SCA13 Problem
California's bond counsel says the proposed stem cell ballot measure will not interfere with the ability of the state to issue stem cell research bonds, contrary to the position taken by CIRM.
The Sacramento Bee Wednesday disclosed the existence of the memo from Orrick, Herrington & Sutcliffe. The Bee said in an editorial, "(Sen. Deborah) Ortiz has worked to amend her measure so it would have no possible impact on the issuance of stem cell bonds. The state's bond counsel - Orrick, Herrington & Sutcliffe - confirmed that point Tuesday when it issued a memo stating: 'Nothing in the proposed Section 9(a) interferes with the ability of the state to issue tax-exempt bonds.'"
The piece also discussed the opposition of Democratic senators, Sens. Jackie Speier, D-Hillsborough, and Joe Dunn, D-Santa Ana, to SCA13. Dunn is reportedly seeking to have the measure removed from the Senate floor and sent to the Judiciary committee he chairs. The measure has already been through three Senate committees.
The Bee said, "Dunn and Speier have built their reputations on consumer protection, accessible health care and open government. But Monday, they blatantly pandered to stem cell czar Robert Klein II, who orchestrated a lobbying campaign Monday against Sen. Deborah Ortiz, D-Sacramento, and her SCA 13 measure.
"Ortiz's measure, among other things, would guard against public funds going to companies that secretly set up consulting and stock deals with scientists who recommend the funding.
"This is not just an abstract concern.
"As Dunn knows, the energy giant Enron secretly paid researchers at Harvard to churn out reports extolling the deregulation scheme that California ultimately adopted. Those conflicts came to light only after California became mired in an energy crisis Enron helped create."
Dunn has been heavily involved into looking to energy issues related to the California electricity crisis of a few years back.
The Sacramento Bee Wednesday disclosed the existence of the memo from Orrick, Herrington & Sutcliffe. The Bee said in an editorial, "(Sen. Deborah) Ortiz has worked to amend her measure so it would have no possible impact on the issuance of stem cell bonds. The state's bond counsel - Orrick, Herrington & Sutcliffe - confirmed that point Tuesday when it issued a memo stating: 'Nothing in the proposed Section 9(a) interferes with the ability of the state to issue tax-exempt bonds.'"
The piece also discussed the opposition of Democratic senators, Sens. Jackie Speier, D-Hillsborough, and Joe Dunn, D-Santa Ana, to SCA13. Dunn is reportedly seeking to have the measure removed from the Senate floor and sent to the Judiciary committee he chairs. The measure has already been through three Senate committees.
The Bee said, "Dunn and Speier have built their reputations on consumer protection, accessible health care and open government. But Monday, they blatantly pandered to stem cell czar Robert Klein II, who orchestrated a lobbying campaign Monday against Sen. Deborah Ortiz, D-Sacramento, and her SCA 13 measure.
"Ortiz's measure, among other things, would guard against public funds going to companies that secretly set up consulting and stock deals with scientists who recommend the funding.
"This is not just an abstract concern.
"As Dunn knows, the energy giant Enron secretly paid researchers at Harvard to churn out reports extolling the deregulation scheme that California ultimately adopted. Those conflicts came to light only after California became mired in an energy crisis Enron helped create."
Dunn has been heavily involved into looking to energy issues related to the California electricity crisis of a few years back.
Chron Makes Stem Cell News Easier to Find
The San Francisco Chronicle is aggregating its stem cell coverage online, a move that should be emulated by other California newspapers and news sites. Now if the SFGate would only put an RSS feed on the package so that it would alert "stemmies" automatically when updates are made. You can see what appears to be all of the 2005 stem cell stories that have appeared in the paper by just going to this link. The package goes back to Jan. 4 and also includes editorials, another useful feature.
Tuesday, June 07, 2005
Public Posturing, the "Trust Us" Position and Industry Ties
The face-off Monday between the California stem cell agency and California's most influential legislator on stem cell matters does not appear to have resolved much, at least based on news reports.
Something could be bubbling below the surface, but it is not making much of a ripple yet.
At the Monday meeting, Sen. Deborah Ortiz, D-Sacramento, argued that the agency should support her measure. Oversight Committee members were not impressed.
Reporter Dan Morain of the Los Angeles Times quoted Caltech President David Baltimore as saying, "I don't know what her motivation is. But I know the result is extremely dangerous and could undermine the whole reputation of the state as a leader in stem cell research."
Ortiz said she will press forward with a vote on SCA13 later this week. But, according to Morain, Ortiz pledged that if the Legislature's attorney or state bond attorneys tell her she is "jeopardizing bonds, or my criteria and language is too vague and will encourage litigation, I will not move the measure forward."
"I'm driven by that, but it has to be based on the attorneys I'm working with," Ortiz said.
Reporter Carl Hall of the San Francisco Chronicle wrote, "Ortiz said she hasn't ruled out the possibility of withdrawing her proposal if the stem cell institute makes the right moves, and she repeatedly promised to make any changes that are needed to clear up worries about bond issues."
The public events predictably involved some posturing on both sides. Whether a compromise can be worked out is difficult to tell from this perspective.
The Oversight Committee says SCA13 is a life-and-death matter so Ortiz should back off. The same argument can said for its stance. Intransigence by the board certainly is a major element in keeping this whole issue alive.
The merits of the agency's "trust us" position goes only so far. California history is replete with examples of agencies that were or are little more than handmaidens of the industries they are supposed to regulate or are connected to in some fashion. The board that oversees physicians is one example, although it has improved in the last 10 or 20 years. Agriculture is another example of an agency that is a captive of its industry, which is one of the largest in California. The real estate department is still another.
The stem cell agency already has built-in ties with its industry. Those links are likely to grow in coming years. It behooves the Oversight Committee to at least assure disclosure of basic information about such connections, one of the matters that the Ortiz legislation concerns.
As for the argument that scientists would turn away from stem cell research grants because of economic disclosure requirements -- give us a break. Certainly a few might, but these are likely to be folks whose industry ties are dubious. Venture capitalists have long been successful at compelling entrepreneurs to surrender to the most onerous demands. The lure of $3 billion is likely to overcome the reluctance of any sensible scientist.
Here are related links to SCA13: Sacramento Bee story by Kevin Yamamura, the latest CIRM analysis of SCA13(June 1 version of the measure).
In separate items below is information from Ortiz' office that is not available on her web site.
Something could be bubbling below the surface, but it is not making much of a ripple yet.
At the Monday meeting, Sen. Deborah Ortiz, D-Sacramento, argued that the agency should support her measure. Oversight Committee members were not impressed.
Reporter Dan Morain of the Los Angeles Times quoted Caltech President David Baltimore as saying, "I don't know what her motivation is. But I know the result is extremely dangerous and could undermine the whole reputation of the state as a leader in stem cell research."
Ortiz said she will press forward with a vote on SCA13 later this week. But, according to Morain, Ortiz pledged that if the Legislature's attorney or state bond attorneys tell her she is "jeopardizing bonds, or my criteria and language is too vague and will encourage litigation, I will not move the measure forward."
"I'm driven by that, but it has to be based on the attorneys I'm working with," Ortiz said.
Reporter Carl Hall of the San Francisco Chronicle wrote, "Ortiz said she hasn't ruled out the possibility of withdrawing her proposal if the stem cell institute makes the right moves, and she repeatedly promised to make any changes that are needed to clear up worries about bond issues."
The public events predictably involved some posturing on both sides. Whether a compromise can be worked out is difficult to tell from this perspective.
The Oversight Committee says SCA13 is a life-and-death matter so Ortiz should back off. The same argument can said for its stance. Intransigence by the board certainly is a major element in keeping this whole issue alive.
The merits of the agency's "trust us" position goes only so far. California history is replete with examples of agencies that were or are little more than handmaidens of the industries they are supposed to regulate or are connected to in some fashion. The board that oversees physicians is one example, although it has improved in the last 10 or 20 years. Agriculture is another example of an agency that is a captive of its industry, which is one of the largest in California. The real estate department is still another.
The stem cell agency already has built-in ties with its industry. Those links are likely to grow in coming years. It behooves the Oversight Committee to at least assure disclosure of basic information about such connections, one of the matters that the Ortiz legislation concerns.
As for the argument that scientists would turn away from stem cell research grants because of economic disclosure requirements -- give us a break. Certainly a few might, but these are likely to be folks whose industry ties are dubious. Venture capitalists have long been successful at compelling entrepreneurs to surrender to the most onerous demands. The lure of $3 billion is likely to overcome the reluctance of any sensible scientist.
Here are related links to SCA13: Sacramento Bee story by Kevin Yamamura, the latest CIRM analysis of SCA13(June 1 version of the measure).
In separate items below is information from Ortiz' office that is not available on her web site.
SCA13: Ortiz Statement
The following is from Sen. Ortiz' office and was not available on her web site this morning.
SENATOR ORTIZ’S STATEMENT ON SCA 13
SACRAMENTO – Senator Deborah Ortiz (D-Sacramento) today issued the following statement after addressing the Independent Citizen’s Oversight Committee regarding Senate Constitutional Amendment 13:
“I introduced Senate Constitutional Amendment 13 with one purpose: to strengthen Proposition 71 regarding conflicts of interest and financial disclosures, ensuring public accountability and open participation in the $3 billion, taxpayer-funded California stem cell research program.
“I have had numerous conversations and meetings with stem cell research advocates, officials with the California Institute for Regenerative Medicine, members of the Independent Citizens Oversight Committee, medical and scientific experts, and both tax and bond counsel.
“We have made progress in crafting a measure that will provide full accountability and ensure the public’s confidence in the integrity of the system. I have been working with legislative and bond counsel to ensure that SCA 13 will do nothing to jeopardize the ability of stem cell research to proceed or hamper the state’s authority to issue tax-exempt bonds. Under SCA 13, California will continue to attract the best and brightest scientists and researchers, protecting their legitimate privacy concerns while making sure that research grants they recommend for funding are the best proposed projects.
“The only remaining issue is how we secure a strong commitment from the ICOC to deliver the therapies and drugs developed through stem cell research to Californians who face catastrophic illnesses and huge medical and prescription drug expenses. Despite its promise, Proposition 71 as currently written does not provide a way to ensure the results of stem cell research are made affordable and accessible to California’s health programs and needy residents.
“I urge members of the ICOC to continue working with me to ensure Proposition 71 delivers on its promise while protecting the taxpayers’ investment. California is the venture capitalist in this bold endeavor. The state’s residents are funding the research; they should have access to the cures that are developed as a result of their generosity and their hopes.”
# # #
SENATOR ORTIZ’S STATEMENT ON SCA 13
SACRAMENTO – Senator Deborah Ortiz (D-Sacramento) today issued the following statement after addressing the Independent Citizen’s Oversight Committee regarding Senate Constitutional Amendment 13:
“I introduced Senate Constitutional Amendment 13 with one purpose: to strengthen Proposition 71 regarding conflicts of interest and financial disclosures, ensuring public accountability and open participation in the $3 billion, taxpayer-funded California stem cell research program.
“I have had numerous conversations and meetings with stem cell research advocates, officials with the California Institute for Regenerative Medicine, members of the Independent Citizens Oversight Committee, medical and scientific experts, and both tax and bond counsel.
“We have made progress in crafting a measure that will provide full accountability and ensure the public’s confidence in the integrity of the system. I have been working with legislative and bond counsel to ensure that SCA 13 will do nothing to jeopardize the ability of stem cell research to proceed or hamper the state’s authority to issue tax-exempt bonds. Under SCA 13, California will continue to attract the best and brightest scientists and researchers, protecting their legitimate privacy concerns while making sure that research grants they recommend for funding are the best proposed projects.
“The only remaining issue is how we secure a strong commitment from the ICOC to deliver the therapies and drugs developed through stem cell research to Californians who face catastrophic illnesses and huge medical and prescription drug expenses. Despite its promise, Proposition 71 as currently written does not provide a way to ensure the results of stem cell research are made affordable and accessible to California’s health programs and needy residents.
“I urge members of the ICOC to continue working with me to ensure Proposition 71 delivers on its promise while protecting the taxpayers’ investment. California is the venture capitalist in this bold endeavor. The state’s residents are funding the research; they should have access to the cures that are developed as a result of their generosity and their hopes.”
# # #
SCA13: Ortiz' Summary
The following is from Sen. Ortiz' office and is not available on her website:
SCA 13 (Ortiz and Runner)
Prop. 71 Open Meetings, Conflict of Interest,
and Patenting and Licensing
Fact Sheet
SCA 13 would strengthen the public accountability provisions of Proposition 71, the Stem Cell Research and Cures initiative, by ensuring that principles of open government, protections against conflicts of interest, and the taxpayers’ interest are fully incorporated in decision-making under the initiative.
In passing Proposition 71, voters have entrusted the state with managing $3 billion in new funds for stem cell research. The cost of repaying bonds with interest will range up to $6 billion.
While Proposition 71 contains provisions concerning open meetings, conflicts of interest, and handling of royalties and intellectual property rights, as drafted and as they are being implemented by the ICOC, they do not go far enough to fully protect the state's interest. For example:
The initiative and the implementation of it explicitly exempts some Proposition 71 working groups from open meeting requirements, even when they consider broad policies and standards. These are expert groups whose recommendations will carry enormous weight, and are unlikely to be overturned by the governing committee.
The initiative and the ICOC’s implementation of it fail to require disclosure of economic interests by working group members, and instead relies on self-certification of conflicts of interest.
Regarding patents and licenses associated with research funded by Prop. 71, the initiative simply requires the ICOC to balance the interests of taxpayers with those of ensuring that important research moves forward, instead of ensuring therapies and treatments resulting from Prop. 71-funded research are accessible and affordable.
What SCA 13 Does
SCA addresses these problems by:
Applying open meeting standards to all deliberations of the ICOC and its working groups, with exceptions as necessary to conduct scientific peer review and to protect proprietary or scientific prepublication information;
Allowing an opportunity for public comment on the basis for approval or denial of applications for funding before recommendations for funding are submitted to the ICOC;
Requiring working group members to disclose to the ICOC relevant economic and property interests and to adhere to NIH economic conflict of interest standards, and requiring the State Auditor to periodically review the ICOC’s monitoring and enforcement of conflict of interest provisions for working group members;
Requiring the ICOC to seek to ensure, in negotiating intellectual property agreements, that therapies and treatments resulting from inventions and technologies developed with Prop. 71 funding are accessible and affordable to low-income residents, including those eligible for state and county-funded health care programs.
Proposition 71 gives California an opportunity to realize the enormous potential represented by stem cell research. SCA 13 simply ensures that Prop. 71 funding decisions are reached and carried out in a publicly accountable manner.
Organizations in Support
Californians Aware
CALPIRG
Common Cause
California Tax Reform Association
SCA 13 (Ortiz and Runner)
Prop. 71 Open Meetings, Conflict of Interest,
and Patenting and Licensing
Fact Sheet
SCA 13 would strengthen the public accountability provisions of Proposition 71, the Stem Cell Research and Cures initiative, by ensuring that principles of open government, protections against conflicts of interest, and the taxpayers’ interest are fully incorporated in decision-making under the initiative.
In passing Proposition 71, voters have entrusted the state with managing $3 billion in new funds for stem cell research. The cost of repaying bonds with interest will range up to $6 billion.
While Proposition 71 contains provisions concerning open meetings, conflicts of interest, and handling of royalties and intellectual property rights, as drafted and as they are being implemented by the ICOC, they do not go far enough to fully protect the state's interest. For example:
The initiative and the implementation of it explicitly exempts some Proposition 71 working groups from open meeting requirements, even when they consider broad policies and standards. These are expert groups whose recommendations will carry enormous weight, and are unlikely to be overturned by the governing committee.
The initiative and the ICOC’s implementation of it fail to require disclosure of economic interests by working group members, and instead relies on self-certification of conflicts of interest.
Regarding patents and licenses associated with research funded by Prop. 71, the initiative simply requires the ICOC to balance the interests of taxpayers with those of ensuring that important research moves forward, instead of ensuring therapies and treatments resulting from Prop. 71-funded research are accessible and affordable.
What SCA 13 Does
SCA addresses these problems by:
Applying open meeting standards to all deliberations of the ICOC and its working groups, with exceptions as necessary to conduct scientific peer review and to protect proprietary or scientific prepublication information;
Allowing an opportunity for public comment on the basis for approval or denial of applications for funding before recommendations for funding are submitted to the ICOC;
Requiring working group members to disclose to the ICOC relevant economic and property interests and to adhere to NIH economic conflict of interest standards, and requiring the State Auditor to periodically review the ICOC’s monitoring and enforcement of conflict of interest provisions for working group members;
Requiring the ICOC to seek to ensure, in negotiating intellectual property agreements, that therapies and treatments resulting from inventions and technologies developed with Prop. 71 funding are accessible and affordable to low-income residents, including those eligible for state and county-funded health care programs.
Proposition 71 gives California an opportunity to realize the enormous potential represented by stem cell research. SCA 13 simply ensures that Prop. 71 funding decisions are reached and carried out in a publicly accountable manner.
Organizations in Support
Californians Aware
CALPIRG
Common Cause
California Tax Reform Association
SCA13: Current and Planned Amendments
The following is from Sen. Ortiz' office and is not available on her website:
SCA 13 (Ortiz) – Current and Planned Amendments
Issue
SCA 13 as Amended 5/31/05
Planned Amendments
Open Meetings
--ICOC and Institute
Meetings of Institute and ICOC subject to California open meeting laws, with exceptions permitted under the Bagley-Keene open meeting act, consistent with Prop. 71 as drafted.
Clarify that the ICOC may consider matters involving patient information, confidential intellectual property or work products, matters involving prepublication, scientific information or data, and matters involving personnel, and that records including such information are exempt from public disclosure.
--Working Groups
Allowed to conduct closed sessions to conduct peer review, including to evaluate and score individual projects, and to consider matters involving intellectual property, proprietary information, and prepublication scientific information.
Grants working group required to produce a written summary of its reasons for funding or not funding any project as well as how each project recommended for funding will benefit California residents. it would also be asked to conduct an open public meeting to solicit public comments before submitting recommendations to the ICOC.
Written summaries could be posted on the Institute’s website, with an opportunity for the public to post comments, in lieu of holding a public meeting to invite public comment.
Public summaries of projects limited to a short description of the project, the disease category addressed by the project, the geographic region represented by the project, and the general reasons for the decision to fund or not fund the project. Intent is not to identify individual applicants or to publicly air the specific weaknesses of their proposals.
Conflicts of Interest
--ICOC members, Chair, Vice Chair, President of Institute
Required to file form 700’s and disclose their economic interests in the manner set forth in the Political Reform Act, as currently required in prop. 71
Required to divest or place in blind trust any financial or real property interest in any organization that applies for funding or that has substantial interests in stem cell therapy, defined as greater than 5 percent of its research budget.
Delete the divestiture requirement for ICOC members, Chair, Vice Chair, and President, and instead rely on the existing PRA disclosure and recusal requirements, or narrow the divestiture requirement to financial investments in designated entities.
--Working group members
Required to file form 700s and disclose their economic interests to the ICOC.
ICOC would provide the State Auditor with the disclosure statements. Auditor would be required to annually review disclosure statements as well as decisions or recommendations of each working group member and report findings to the Legislature regarding whether working group members have complied with requirements.
Apply the NIH requirement that members must recuse themselves from deliberation on any proposal if they or a close relative or professional associate has a financial interest in the proposal, including a direct benefit of any type deriving from the proposal itself, or a financial benefit of any type from an applicant institution of over $5,000 per year, including honoraria, fees, stock, or other benefits.
Narrow the scope of disclosure for working group members, perhaps to reporting interests (investments and income) in entities doing business with the institute and in biotech and pharmaceutical companies.
Intellectual Property
Requires grants and contracts to ensure that clinical treatments resulting from the research are made available at affordable costs to low-income residents and that the state is provided with a share of the royalties or revenues derived from the development of the treatments or services.
Delete the “except as otherwise provided in this article” language in section 6 of the bill, to make it clear that any conditions imposed by the bill are not conditions on the sale of the bonds themselves.
Delete the specific criteria in section 9 in favor of a broader policy statement requiring the ICOC, in negotiating intellectual property agreements, to ensure that therapies and treatments resulting from research funded by Prop. 71 dollars are affordable and accessible to California residents, particularly those eligible for state and county funded programs. This will remove grounds for litigation of individual projects and focus IP agreements in areas that produce the greatest benefits for taxpayers and do not jeopardize the ability to use tax-exempt bonds.
SCA 13 (Ortiz) – Current and Planned Amendments
Issue
SCA 13 as Amended 5/31/05
Planned Amendments
Open Meetings
--ICOC and Institute
Meetings of Institute and ICOC subject to California open meeting laws, with exceptions permitted under the Bagley-Keene open meeting act, consistent with Prop. 71 as drafted.
Clarify that the ICOC may consider matters involving patient information, confidential intellectual property or work products, matters involving prepublication, scientific information or data, and matters involving personnel, and that records including such information are exempt from public disclosure.
--Working Groups
Allowed to conduct closed sessions to conduct peer review, including to evaluate and score individual projects, and to consider matters involving intellectual property, proprietary information, and prepublication scientific information.
Grants working group required to produce a written summary of its reasons for funding or not funding any project as well as how each project recommended for funding will benefit California residents. it would also be asked to conduct an open public meeting to solicit public comments before submitting recommendations to the ICOC.
Written summaries could be posted on the Institute’s website, with an opportunity for the public to post comments, in lieu of holding a public meeting to invite public comment.
Public summaries of projects limited to a short description of the project, the disease category addressed by the project, the geographic region represented by the project, and the general reasons for the decision to fund or not fund the project. Intent is not to identify individual applicants or to publicly air the specific weaknesses of their proposals.
Conflicts of Interest
--ICOC members, Chair, Vice Chair, President of Institute
Required to file form 700’s and disclose their economic interests in the manner set forth in the Political Reform Act, as currently required in prop. 71
Required to divest or place in blind trust any financial or real property interest in any organization that applies for funding or that has substantial interests in stem cell therapy, defined as greater than 5 percent of its research budget.
Delete the divestiture requirement for ICOC members, Chair, Vice Chair, and President, and instead rely on the existing PRA disclosure and recusal requirements, or narrow the divestiture requirement to financial investments in designated entities.
--Working group members
Required to file form 700s and disclose their economic interests to the ICOC.
ICOC would provide the State Auditor with the disclosure statements. Auditor would be required to annually review disclosure statements as well as decisions or recommendations of each working group member and report findings to the Legislature regarding whether working group members have complied with requirements.
Apply the NIH requirement that members must recuse themselves from deliberation on any proposal if they or a close relative or professional associate has a financial interest in the proposal, including a direct benefit of any type deriving from the proposal itself, or a financial benefit of any type from an applicant institution of over $5,000 per year, including honoraria, fees, stock, or other benefits.
Narrow the scope of disclosure for working group members, perhaps to reporting interests (investments and income) in entities doing business with the institute and in biotech and pharmaceutical companies.
Intellectual Property
Requires grants and contracts to ensure that clinical treatments resulting from the research are made available at affordable costs to low-income residents and that the state is provided with a share of the royalties or revenues derived from the development of the treatments or services.
Delete the “except as otherwise provided in this article” language in section 6 of the bill, to make it clear that any conditions imposed by the bill are not conditions on the sale of the bonds themselves.
Delete the specific criteria in section 9 in favor of a broader policy statement requiring the ICOC, in negotiating intellectual property agreements, to ensure that therapies and treatments resulting from research funded by Prop. 71 dollars are affordable and accessible to California residents, particularly those eligible for state and county funded programs. This will remove grounds for litigation of individual projects and focus IP agreements in areas that produce the greatest benefits for taxpayers and do not jeopardize the ability to use tax-exempt bonds.
Monday, June 06, 2005
Cash Rolls In, Contracts Roll Out
The California stem cell agency has some good news today – a $5 million grant from the man responsible for Dolby sound on recordings.
Both The Sacramento Bee and the San Francisco Chronicle reported the donation this morning. Stem cell chairman Robert Klein
told reporter Carl Hall of the Chronicle that "the $5 million will be used to hire the legal, scientific and intellectual-property staff needed to proceed with the first grant programs, while the institute also pursues a $100 million short-term bridge financing plan."
"In a news release planned for today, Klein said, 'The Dolbys are fascinated by the possibility of a significant advancement of medical science through regenerative medicine research,'" Hall reported. The grant comes from both Ray Dolby and his wife, Dagmar.
The agency has run through about half of its $3 million startup loan from the state and will run out of money in November if it does not receive additional funds.
Reporter Laura Mecoy of The Bee wrote that the agency has signed contracts worth $1.1 million with private firms, including lobbyists and lawyers, and has more in the works. She said that Klein could recall only one that was competitively bid: an executive search firm's contract.
Mecoy continued, "While most other state agencies must solicit bids on contracts worth $4,999 or more, Klein said the institute doesn't have to go through the bidding process for its personal-services contracts.
"He cited a little-known provision of Prop. 71, the initiative that created the institute, that exempts the stem cell institute from competitive bidding requirements for such contracts.
"He said it's based on a University of California exemption that gives health-related agencies the leeway to contract with those with specialized knowledge.
"He contended that each of the contracts, including one being negotiated for the Edelman public relations firm, required such specialized knowledge."
Chronicle reporter Hall said that the University of California has loaned the stem cell agency staff assistance in human resources and hiring. It was not clear whether the agency would repay UC, which has its own financial problems, for the help.
For more on Edelman, see the "Hello to Edelman" and "Edelman Blog" items on April 22. For more on the contracts, see "$10,000 Lobbyist" May 5.
Both The Sacramento Bee and the San Francisco Chronicle reported the donation this morning. Stem cell chairman Robert Klein
told reporter Carl Hall of the Chronicle that "the $5 million will be used to hire the legal, scientific and intellectual-property staff needed to proceed with the first grant programs, while the institute also pursues a $100 million short-term bridge financing plan."
"In a news release planned for today, Klein said, 'The Dolbys are fascinated by the possibility of a significant advancement of medical science through regenerative medicine research,'" Hall reported. The grant comes from both Ray Dolby and his wife, Dagmar.
The agency has run through about half of its $3 million startup loan from the state and will run out of money in November if it does not receive additional funds.
Reporter Laura Mecoy of The Bee wrote that the agency has signed contracts worth $1.1 million with private firms, including lobbyists and lawyers, and has more in the works. She said that Klein could recall only one that was competitively bid: an executive search firm's contract.
Mecoy continued, "While most other state agencies must solicit bids on contracts worth $4,999 or more, Klein said the institute doesn't have to go through the bidding process for its personal-services contracts.
"He cited a little-known provision of Prop. 71, the initiative that created the institute, that exempts the stem cell institute from competitive bidding requirements for such contracts.
"He said it's based on a University of California exemption that gives health-related agencies the leeway to contract with those with specialized knowledge.
"He contended that each of the contracts, including one being negotiated for the Edelman public relations firm, required such specialized knowledge."
Chronicle reporter Hall said that the University of California has loaned the stem cell agency staff assistance in human resources and hiring. It was not clear whether the agency would repay UC, which has its own financial problems, for the help.
For more on Edelman, see the "Hello to Edelman" and "Edelman Blog" items on April 22. For more on the contracts, see "$10,000 Lobbyist" May 5.
Sunday, June 05, 2005
CIRM Battling on Wrong Turf
From the White House to India, readers around the world on Sunday were told of the travails of the California stem cell agency.
"A battle for control of the $3 billion in research money voters approved last year has unraveled the alliance and threatens to hinder the California Institute for Regenerative Medicine even before it awards its first grant, agency officials say."
That was the second paragraph of a 788-word story by biotechnology reporter Paul Elias of The Associated Press. The story was circulated globally by the news service.
The story primarily focused on the battle over SCA13, the proposed ballot measure to tighten oversight of the agency. Pretty familiar ground for readers of this blog, but new to most others.
What makes this important for the agency is the continuing drumbeat of negative coverage nationally and internationally. While Elias' piece was straightforward, its overall impact was not good for the agency. It should instead be generating coverage of accomplishment and good works.
CIRM is fighting a PR battle on its enemies' turf instead of building on the considerable good will coming out of last fall's election in which 59 percent of the voters approved creation of the agency. It is time for the agency to do what is necessary to defuse the major issues so that it can move beyond the corrosive criticism that is eroding its effectiveness.
That also seems to the sentiment of at least one member of the stem cell Oversight committee, Dr. Francisco Prieto. He told Elias that he hopes a compromise can be reached soon on SCA13.
"I think the approach we have taken as a board has been more confrontational than it needs to be," Prieto said.
For more on the long range impact of the proposed ballot measure, see the "Vote Again..." item April 15 on this blog.
"A battle for control of the $3 billion in research money voters approved last year has unraveled the alliance and threatens to hinder the California Institute for Regenerative Medicine even before it awards its first grant, agency officials say."
That was the second paragraph of a 788-word story by biotechnology reporter Paul Elias of The Associated Press. The story was circulated globally by the news service.
The story primarily focused on the battle over SCA13, the proposed ballot measure to tighten oversight of the agency. Pretty familiar ground for readers of this blog, but new to most others.
What makes this important for the agency is the continuing drumbeat of negative coverage nationally and internationally. While Elias' piece was straightforward, its overall impact was not good for the agency. It should instead be generating coverage of accomplishment and good works.
CIRM is fighting a PR battle on its enemies' turf instead of building on the considerable good will coming out of last fall's election in which 59 percent of the voters approved creation of the agency. It is time for the agency to do what is necessary to defuse the major issues so that it can move beyond the corrosive criticism that is eroding its effectiveness.
That also seems to the sentiment of at least one member of the stem cell Oversight committee, Dr. Francisco Prieto. He told Elias that he hopes a compromise can be reached soon on SCA13.
"I think the approach we have taken as a board has been more confrontational than it needs to be," Prieto said.
For more on the long range impact of the proposed ballot measure, see the "Vote Again..." item April 15 on this blog.
Is CIRM Truly Transparent?
Count the reasons why the California stem cell agency should be more open to the public. There are 75,027 of them.
At least that's a start.
Take 27 of them first. The agency noted with some pride last week that 27 California institutions have expressed an interest in an important training grant program to create a cadre of stem cell researchers. Most of them are undoubtedly public or nonprofit universities, colleges or nonprofit organizations, such as the Salk Institute.
But will California taxpayers ever learn the identity of these institutions, except for the handful ultimately selected? Not according to CIRM, which rebuffed a request for their identities because the grants are ostensibly being handled by a "working group." Those are entities linked to CIRM but whose records are closed to public view.
This is a level of secrecy that exceeds that of the California's governor's office. For example, the governor's daily schedule is a public record. We can learn who he met with and the subject of meetings. Not so with working groups, apparently.
The names of the 27 institutions are a relatively minor matter, but one wonders what other information is or will be cloaked in secrecy, despite the promises by the agency to set the highest standards of openness and transparency.
Now for the 75,000 other reasons. That is the national number of "expert clinicians and researchers (who) now consult for hedge funds, stock analysts, venture capitalists or other sophisticated investors." So reports a study published last month in the Journal of the American Medical Association, which was critical of the practice.
"That's up from 15,000 doctors who consulted in 2002, and fewer than 1,000 in 1996," wrote reporter Luke Timmerman in the Seattle Times, in a piece about the study. That amounts to one in 10 physicians nationwide.
While the study did not deal directly with stem cell research, it indicated the growing scope of the problem of ethical behavior involving medical affairs and research. Critics of the stem cell agency want broader public disclosure of the financial interests of key personnel. "But that's not the way it has always been done" is the thrust of CIRM's position. More aggressive disclosure will drive scientists away from the $3 billion research pool, CIRM contends.
Times have changed, however, as the AMA article points out. In less than 10 years, tens of thousands of physicians have begun to engage in activities that the editor of the AMA Journal now finds "hard to believe."
The AMA article dealt primarily with the private sector. CIRM is handling public money. While there is clearly a need for protection of proprietary information, personnel matters and other such information, the public deserves more, rather than less disclosure of CIRM's most sensitive workings.
At least that's a start.
Take 27 of them first. The agency noted with some pride last week that 27 California institutions have expressed an interest in an important training grant program to create a cadre of stem cell researchers. Most of them are undoubtedly public or nonprofit universities, colleges or nonprofit organizations, such as the Salk Institute.
But will California taxpayers ever learn the identity of these institutions, except for the handful ultimately selected? Not according to CIRM, which rebuffed a request for their identities because the grants are ostensibly being handled by a "working group." Those are entities linked to CIRM but whose records are closed to public view.
This is a level of secrecy that exceeds that of the California's governor's office. For example, the governor's daily schedule is a public record. We can learn who he met with and the subject of meetings. Not so with working groups, apparently.
The names of the 27 institutions are a relatively minor matter, but one wonders what other information is or will be cloaked in secrecy, despite the promises by the agency to set the highest standards of openness and transparency.
Now for the 75,000 other reasons. That is the national number of "expert clinicians and researchers (who) now consult for hedge funds, stock analysts, venture capitalists or other sophisticated investors." So reports a study published last month in the Journal of the American Medical Association, which was critical of the practice.
"That's up from 15,000 doctors who consulted in 2002, and fewer than 1,000 in 1996," wrote reporter Luke Timmerman in the Seattle Times, in a piece about the study. That amounts to one in 10 physicians nationwide.
While the study did not deal directly with stem cell research, it indicated the growing scope of the problem of ethical behavior involving medical affairs and research. Critics of the stem cell agency want broader public disclosure of the financial interests of key personnel. "But that's not the way it has always been done" is the thrust of CIRM's position. More aggressive disclosure will drive scientists away from the $3 billion research pool, CIRM contends.
Times have changed, however, as the AMA article points out. In less than 10 years, tens of thousands of physicians have begun to engage in activities that the editor of the AMA Journal now finds "hard to believe."
The AMA article dealt primarily with the private sector. CIRM is handling public money. While there is clearly a need for protection of proprietary information, personnel matters and other such information, the public deserves more, rather than less disclosure of CIRM's most sensitive workings.
Ortiz To Address CIRM Monday Morning
The California state senator behind the proposed ballot measure to tighten oversight of the California stem cell agency will appear before that agency on Monday.
Sen. Deborah Ortiz, chair of the Senate Health Committee and the most influential state lawmaker on stem cell issues, was invited on Thursday to speak to the Oversight Committee Monday morning in Sacramento.
The committee scheduled the meeting for Sacramento so that it could lobby against Ortiz' proposed constitutional amendment, SCA13, which may be taken up this week by the full Senate.
The board unanimously opposes the measure.
Ortiz' appearance poses an interesting contrast to the position taken by stem cell chairman Robert Klein, who refused to testify before an unusual joint hearing of the Senate and Assembly Health Committee into the new agency and related stem cell issues.
For more on Klein's refusal, see the following items on this blog: "Missing Man" March 15, "Roiling Undercurrents" March 16.
Sen. Deborah Ortiz, chair of the Senate Health Committee and the most influential state lawmaker on stem cell issues, was invited on Thursday to speak to the Oversight Committee Monday morning in Sacramento.
The committee scheduled the meeting for Sacramento so that it could lobby against Ortiz' proposed constitutional amendment, SCA13, which may be taken up this week by the full Senate.
The board unanimously opposes the measure.
Ortiz' appearance poses an interesting contrast to the position taken by stem cell chairman Robert Klein, who refused to testify before an unusual joint hearing of the Senate and Assembly Health Committee into the new agency and related stem cell issues.
For more on Klein's refusal, see the following items on this blog: "Missing Man" March 15, "Roiling Undercurrents" March 16.
The Bridge Loan Plan: A Few More Details
Facing the possibility that it will run out of funds by this fall, the California stem cell agency on Monday will push forward with its "bridge financing" proposal.
Up for consideration at the Oversight Committee meeting in Sacramento is the bridge loan plan along with unspecified other financial possibilities.
CIRM has developed the plan because its normal ability to issue hundreds of millions of dollars in bonds is severely restricted pending the outcome of a lawsuit that challenges the existence of the new agency.
A report prepared by the agency's staff said that two law firms have indicated that the legal challenge is "meritless." The report also contains more details on the legal counter to the lawsuit including legal citations.
The agency proposes to borrow millions from philanthropic groups with the funds either going to the state or "to universities and non-profit research institutions that the Institute has selected to receive research grants." Donors would not be eligible to be grant recipients. The loans would not be paid back if Prop. 71 is overturned.
"We are meeting with the staffs of the Treasurer, the Controller, the Attorney General and the State Director of Finance to ensure that all of the constitutional officers responsible for the state’s finances and its legal obligations concur with this proposal. As those meetings proceed, we are working with the staff for the Treasurer and the Attorney General to draw up appropriate loan documents," the CIRM staff report said.
State Treasurer Phil Angelides on May 10 indicated he would hold a hearing into the matter within a month or so. However, no date has been set for that hearing.
Up for consideration at the Oversight Committee meeting in Sacramento is the bridge loan plan along with unspecified other financial possibilities.
CIRM has developed the plan because its normal ability to issue hundreds of millions of dollars in bonds is severely restricted pending the outcome of a lawsuit that challenges the existence of the new agency.
A report prepared by the agency's staff said that two law firms have indicated that the legal challenge is "meritless." The report also contains more details on the legal counter to the lawsuit including legal citations.
The agency proposes to borrow millions from philanthropic groups with the funds either going to the state or "to universities and non-profit research institutions that the Institute has selected to receive research grants." Donors would not be eligible to be grant recipients. The loans would not be paid back if Prop. 71 is overturned.
"We are meeting with the staffs of the Treasurer, the Controller, the Attorney General and the State Director of Finance to ensure that all of the constitutional officers responsible for the state’s finances and its legal obligations concur with this proposal. As those meetings proceed, we are working with the staff for the Treasurer and the Attorney General to draw up appropriate loan documents," the CIRM staff report said.
State Treasurer Phil Angelides on May 10 indicated he would hold a hearing into the matter within a month or so. However, no date has been set for that hearing.
Thursday, June 02, 2005
Competition for Creation of a Stem Cell Cadre
Twenty-seven California institutions are competing for a share of the first $45 million in grants from the California stem cell agency. It is a contest that will not attract the headlines of the HQ battle but one that is far more important.
The grants, which would be the agency's first, are aimed at creating a cadre of stem cell researchers in California who will push their research into clinical applications. Some grants could range as high as $1.25 million each annually to support as many as 16 "CIRM scholars."
The total of $45 million is expected to be spread out over three years among 18 universities, non-profit academic and research institutions with the first grants being awarded possibly as early as September.
"We are delighted at the robust response to our first call for grants. California’s next generation of scientists and clinicians is clearly eager to begin training for stem cell research and the development of new therapies for disease,” said Zach Hall, CIRM’s interim president. “These grants will create a vital foundation for future stem cell research in California.”
The agency's press release said that the grants are designed to encourage "institutions to create programs in which basic and clinical scientists are trained together in order to promote the flow of information from the laboratory to the clinic. Institutions are also required to offer a course in the social, legal and ethical implications of stem cell research as part of their curricula."
The agency envisions a three-tiered program with both large and small insitutions participating. Here is how CIRM described them.
The grants, which would be the agency's first, are aimed at creating a cadre of stem cell researchers in California who will push their research into clinical applications. Some grants could range as high as $1.25 million each annually to support as many as 16 "CIRM scholars."
The total of $45 million is expected to be spread out over three years among 18 universities, non-profit academic and research institutions with the first grants being awarded possibly as early as September.
"We are delighted at the robust response to our first call for grants. California’s next generation of scientists and clinicians is clearly eager to begin training for stem cell research and the development of new therapies for disease,” said Zach Hall, CIRM’s interim president. “These grants will create a vital foundation for future stem cell research in California.”
The agency's press release said that the grants are designed to encourage "institutions to create programs in which basic and clinical scientists are trained together in order to promote the flow of information from the laboratory to the clinic. Institutions are also required to offer a course in the social, legal and ethical implications of stem cell research as part of their curricula."
The agency envisions a three-tiered program with both large and small insitutions participating. Here is how CIRM described them.
- A "comprehensive training program will educate at the pre-doctoral, post-doctoral and clinical levels. A Type I institutional grant will support up to 16 CIRM Scholars and operate on a total budget of up to $1.25 million per year.
- An "intermediate training program will offer training at two of the three levels of education mentioned above. Type II grants may support up to ten CIRM Scholars at a given institution with a total budget of $800,000.
- A "specialized training program will fund up to six CIRM Scholars at a total budget of $500,000."
The grants are aimed at educating students from "scientifically diverse backgrounds—including the relevant fields of biology, clinical training programs, bioengineering, as well as ethics and the law," the agency said.
"Because of the diversity of the California population, CIRM is particularly interested in training a diverse pool of investigators, including under-represented minorities, as CIRM Scholars and Mentors," the agency said.
The institutions, whose names were not immediately available, filed letters indicating their interest in the CIRM training program. The actual grant applications are due July 1.
How to Criticize This Blog and Other Matters
A couple of notes on how to use this web site.
Many of you have e-mail programs that can be used to automatically subscribe to the California Stem Cell Report. For example in Mozilla Thunderbird, you can do that by clicking on "subscribe" under the "file" command. Or you can use something called Bloglines. That is a free service that will handle multiple subscriptions and alert you automatically when new material is available. There are other ways to deal with subscriptions, which are known as RSS, Atom or Site Feeds. Here is a link to an article that will tell you more.
For those of you want to comment on an item, criticize this blog or praise or criticize the stem cell agency, you can do so directly on this blog. When the muse strikes you, click on "comments," which appears after each item. Your prose will be posted, untouched by human hands.
Many of you have e-mail programs that can be used to automatically subscribe to the California Stem Cell Report. For example in Mozilla Thunderbird, you can do that by clicking on "subscribe" under the "file" command. Or you can use something called Bloglines. That is a free service that will handle multiple subscriptions and alert you automatically when new material is available. There are other ways to deal with subscriptions, which are known as RSS, Atom or Site Feeds. Here is a link to an article that will tell you more.
For those of you want to comment on an item, criticize this blog or praise or criticize the stem cell agency, you can do so directly on this blog. When the muse strikes you, click on "comments," which appears after each item. Your prose will be posted, untouched by human hands.
SCA13 Delayed, SB18 Advances to Assembly
Legislation requiring a performance audit of the California stem cell agency and creating protection for egg donors swept through the Senate on a 37-0 vote. However, a vote has been delayed at least until sometime next week on SCA13, the measure to tighten oversight of the agency.
The audit measure, SB18 by Sens. Deborah Ortiz, D-Sacramento, and George Runner, R-Antelope Valley, would require the State Auditor to conduct a performance audit of the California Institute for Regenerative Medicine and the Independent Citizen’s Oversight Committee. The first audit report would be due to the Legislature by June 30, 2006.
The bill also would restore patient protections for egg and embryo donors by: requiring physicians to provide donors with a written summary of health impacts associated with human oocyte production, requiring donors to give written consent before donating oocytes for purposes of research, placing limits on the sale or transfer of human oocytes or embryos and limiting compensation to women to encourage them to produce human oocytes for the purposes of medical research.
The bill encourages the ICOC to commission and undertake research into the health impacts of ovarian stimulation drugs used in assisted oocyte production, according to Ortiz' office.
It now goes to the Assembly for further consideration.
The audit measure, SB18 by Sens. Deborah Ortiz, D-Sacramento, and George Runner, R-Antelope Valley, would require the State Auditor to conduct a performance audit of the California Institute for Regenerative Medicine and the Independent Citizen’s Oversight Committee. The first audit report would be due to the Legislature by June 30, 2006.
The bill also would restore patient protections for egg and embryo donors by: requiring physicians to provide donors with a written summary of health impacts associated with human oocyte production, requiring donors to give written consent before donating oocytes for purposes of research, placing limits on the sale or transfer of human oocytes or embryos and limiting compensation to women to encourage them to produce human oocytes for the purposes of medical research.
The bill encourages the ICOC to commission and undertake research into the health impacts of ovarian stimulation drugs used in assisted oocyte production, according to Ortiz' office.
It now goes to the Assembly for further consideration.
More Job Openings at CIRM
Need work? The California stem cell agency is looking for a few good persons. The latest openings are posted on CIRM web site. They range from the president's job, which should be filled shortly, to the executive assistant to the "chair," which probably is really the chairman instead of piece of furniture.
Oddly, the notices do not indicate a pay range, although previous openings have been filled at salaries that some critics said were too high.
The executive assistant positions require typing, formating and proofreading documents. For those tasks it seems a four-year college degree and "four years of executive assistant experience supporting high level leaders or an equivalent combination of education and experience" are necessary. Admittedly the position has other, more significant responsibilities, but it seems a tad inefficient to have such a highly qualified person doing clerical work. Here are links to the job descriptions.
President, California Institute for Regenerative Medicine (pdf)
Scientific Program Officers and Scientific Review Officers (pdf)
Senior Officer for Medical & Ethical Standards (pdf)
Executive Assistant (pdf)
Executive Assistant to the Chair (pdf)
(Forgive my comments re the "chair" but expression remains an abomination. Next we will see a sentence that goes something like: "The chair impacted the agency's infrastructure." Yuck.)
Oddly, the notices do not indicate a pay range, although previous openings have been filled at salaries that some critics said were too high.
The executive assistant positions require typing, formating and proofreading documents. For those tasks it seems a four-year college degree and "four years of executive assistant experience supporting high level leaders or an equivalent combination of education and experience" are necessary. Admittedly the position has other, more significant responsibilities, but it seems a tad inefficient to have such a highly qualified person doing clerical work. Here are links to the job descriptions.
President, California Institute for Regenerative Medicine (pdf)
Scientific Program Officers and Scientific Review Officers (pdf)
Senior Officer for Medical & Ethical Standards (pdf)
Executive Assistant (pdf)
Executive Assistant to the Chair (pdf)
(Forgive my comments re the "chair" but expression remains an abomination. Next we will see a sentence that goes something like: "The chair impacted the agency's infrastructure." Yuck.)
Wednesday, June 01, 2005
Patient Group Members Mobilize Against SCA13
Members of patient groups are barraging legislators with appeals to reject efforts to tighten oversight of the California stem cell agency. Some of the appeals are being couched in life-and-death terms.
The outpouring was predictable given the deep ties that the agency has with the groups, whose members hope to benefit from future therapies developed by research financed by the agency. A number of the members of the stem cell Oversight Committee come specifically from patient groups. The agency undoubtedly has lists of supporters as well. The allied nonprofit organization that grew out Prop. 71 campaign committee also is likely to be involved in the lobbying campaign, as it was earlier this year.
One email sent from a CIRM address by a CIRM staffer to a group of sympathizers was basically an informational pitch. It did note that the Oversight Committee thought SCA13 would have a detrimental effect. The email included attachments from a number of organizations concerned about SCA13, including the University of California, Stanford, USC, Caltech and the Salk Institute. It also included the agency's critical analysis of the legislation. But the email did not advocate that the recipients take a position or lobby legislators.
We should note that out of the six documents attached to the email, only one has been accessible to the general public in a posting on CIRM's web site.
In response to a question about lobbying on SCA13, Nicole Pagano, a spokeswoman for CIRM, said, "Those advocates who contact us receive information as any member of public would. ICOC members who are patient advocates like Joan Samuelson and Jeff Sheehy may attempt to educate their own communities and constituencies because they are opposed to SCA13 as currently drafted, but CIRM staff is not engaged in mobilization campaign efforts."
The measure is expected to come up for a vote on the Senate floor either Thursday or Friday.
If readers of this blog are interested in receiving copies of the items attached to the CIRM email, please send a note to me at djensen@californiastemcellreport.com. I will send them along to you.
The outpouring was predictable given the deep ties that the agency has with the groups, whose members hope to benefit from future therapies developed by research financed by the agency. A number of the members of the stem cell Oversight Committee come specifically from patient groups. The agency undoubtedly has lists of supporters as well. The allied nonprofit organization that grew out Prop. 71 campaign committee also is likely to be involved in the lobbying campaign, as it was earlier this year.
One email sent from a CIRM address by a CIRM staffer to a group of sympathizers was basically an informational pitch. It did note that the Oversight Committee thought SCA13 would have a detrimental effect. The email included attachments from a number of organizations concerned about SCA13, including the University of California, Stanford, USC, Caltech and the Salk Institute. It also included the agency's critical analysis of the legislation. But the email did not advocate that the recipients take a position or lobby legislators.
We should note that out of the six documents attached to the email, only one has been accessible to the general public in a posting on CIRM's web site.
In response to a question about lobbying on SCA13, Nicole Pagano, a spokeswoman for CIRM, said, "Those advocates who contact us receive information as any member of public would. ICOC members who are patient advocates like Joan Samuelson and Jeff Sheehy may attempt to educate their own communities and constituencies because they are opposed to SCA13 as currently drafted, but CIRM staff is not engaged in mobilization campaign efforts."
The measure is expected to come up for a vote on the Senate floor either Thursday or Friday.
If readers of this blog are interested in receiving copies of the items attached to the CIRM email, please send a note to me at djensen@californiastemcellreport.com. I will send them along to you.
Californians Need Information Not Ballyhoo
Are Californians going to have a chance to genuinely see what the California stem cell agency is going to deal with at its meeting this month in Sacramento?
With three business days left before the meeting on Monday, the agency has posted only a laundry list of items on its web site. The subjects on the list are certainly important, but the information about them is limited to a word or two or a phrase.
We do know the following. Changes are being considered on the agency's conflict of interest code. The Oversight Committee is scheduled to discuss temporary financing measures that will prevent it from running out of money this fall. A proposed ballot measure that would create an electoral donnybrook, also this fall, is up for consideration. Appointment of real estate specialists to a stem cell working group is another topic. Also on the table is a six-month review of the agency. Actually this preceding summary of the agenda contains more information than the actual agenda items themselves.
In past months, the agency has posted background material – usually quite late -- on a few items scheduled to be brought up at the monthly meeting – not a lot but some. However, in May, the agenda for the Oversight Committee was nothing more than a list. The public was out of luck if it wanted to have any reasonable idea of the nature of the issues to be discussed.
As we have noted in the past, even the lowliest school district in California does a better job of informing the public in advance about its meetings.
The stem cell agency has ballyhooed its commitment to openness and transparency. But its actions tell a different story.
Sunday, May 29, 2005
The Blasto-Sisyphean Stem Cell Exercise
Joel Pett, Pulitzer Prize-winning editorial cartoonist of the Lexington Herald-Leader, wrote a short piece on Sunday in the Los Angeles Times introducing four editorial cartons on stem cells, including one involving California.
Pett said, "Cartoonists tend to regard opposition to stem cell research as some blasto-Sisyphean exercise in futility, but Gary Varvel of the Indianapolis Star takes a more ethereal view. And both Signe Wilkinson and Nick Anderson remind us that California plays a leading role in the debate because of Alzheimer's icon Ronald Reagan and the state's recently passed stem cell research initiative."
Iraq, angels and slot machines all played a role in the cartoons. Here is the link to Pett's piece. Click on the names of the cartoonists to see the full display of the cartoon.
Stem Cell Dress of The Day: Thick Skin
Sometimes things get personal in the stem cell business. Just ask stem cell chairman Robert Klein and California State Sen. Deborah Ortiz, who have been at loggerheads concerning California's stem cell agency.
Motives are maligned and heated words are bandied about, if not by the players by the observers and advocates.
Now comes a comment from Don C. Reed, a well-known patient advocate on stem cell issues. He wrote a letter printed in The Sacramento Bee Sunday that involved a statement that he made that he believes was misconstrued. But indirectly he leads us to what may be more important points. Civility and mutual respect are important elements in the public debate about stem cell issues. That does not mean the dialogue should be less than vigorous or less than forthright. Participants have a responsibility to press their points aggressively.
Stem cell matters also can be emotional, a fact that cannot be avoided, but an irritation for some, especially those from cloistered environments(that includes business). So thick skins are the order of the day.
Finally Reed reflects a little on the history of the stem cell movement, saying, "We would not be here without the pioneering efforts of Senator Deborah Ortiz. Her legislation made California the first stem-cell-friendly state in the nation. In my heart, I will always regard her as the mother of stem cell legislation."
No doubt he would also have much the same sentiments about Robert Klein -- aside from the motherhood part.
Motives are maligned and heated words are bandied about, if not by the players by the observers and advocates.
Now comes a comment from Don C. Reed, a well-known patient advocate on stem cell issues. He wrote a letter printed in The Sacramento Bee Sunday that involved a statement that he made that he believes was misconstrued. But indirectly he leads us to what may be more important points. Civility and mutual respect are important elements in the public debate about stem cell issues. That does not mean the dialogue should be less than vigorous or less than forthright. Participants have a responsibility to press their points aggressively.
Stem cell matters also can be emotional, a fact that cannot be avoided, but an irritation for some, especially those from cloistered environments(that includes business). So thick skins are the order of the day.
Finally Reed reflects a little on the history of the stem cell movement, saying, "We would not be here without the pioneering efforts of Senator Deborah Ortiz. Her legislation made California the first stem-cell-friendly state in the nation. In my heart, I will always regard her as the mother of stem cell legislation."
No doubt he would also have much the same sentiments about Robert Klein -- aside from the motherhood part.
The Bee: No Compromise on Ballot Measure
The Sacramento Bee on Sunday said in an editorial that Sen. Deborah Ortiz is giving up too much with changes in her proposed ballot measure to tighten oversight of the California stem cell agency.
The Democratic lawmaker from Sacramento has said she will modify her conflict of interest provisions regarding, in The Bee's terms, the "out-of-state scientists who will hold huge sway in how multimillion-dollar grants are dispersed."
"This peer review group, already appointed, includes distinguished academics from Harvard and other top-flight institutions. But even distinguished academics may have conflicts. Do they hold consulting jobs with biomedical firms who might seek grants? What are their stock holdings?" The Bee editorial said.
"We don't know. Neither does the public. Under a policy (stem cell chairman Robert) Klein has promoted, grant reviewers are only required to disclose potential conflicts to the institute's internal staff. Klein says these employees will aggressively police any conflicts. This is the same short-staffed group that hasn't set up an organization chart, hasn't devised a budget and has trouble responding to records requests.
"The proper policy - required of all appointed public officials in California - is for grant reviewers to fill out a Form 700 disclosure, listing their investments, income, gifts and property. Only then will the public feel comfortable that grant reviewers are making decisions free of any financial entanglements."
The Democratic lawmaker from Sacramento has said she will modify her conflict of interest provisions regarding, in The Bee's terms, the "out-of-state scientists who will hold huge sway in how multimillion-dollar grants are dispersed."
"This peer review group, already appointed, includes distinguished academics from Harvard and other top-flight institutions. But even distinguished academics may have conflicts. Do they hold consulting jobs with biomedical firms who might seek grants? What are their stock holdings?" The Bee editorial said.
"We don't know. Neither does the public. Under a policy (stem cell chairman Robert) Klein has promoted, grant reviewers are only required to disclose potential conflicts to the institute's internal staff. Klein says these employees will aggressively police any conflicts. This is the same short-staffed group that hasn't set up an organization chart, hasn't devised a budget and has trouble responding to records requests.
"The proper policy - required of all appointed public officials in California - is for grant reviewers to fill out a Form 700 disclosure, listing their investments, income, gifts and property. Only then will the public feel comfortable that grant reviewers are making decisions free of any financial entanglements."
Friday, May 27, 2005
Klein: Haste Poses Peril to Agency
California stem cell chairman Robert Klein remains unhappy with the proposed ballot measure on his agency, arguing that it is moving with unwarranted haste through the legislature.
In a statement on CIRM's web site, he declared, "There does not appear to be any compelling reason that this constitutional amendment should be rushed through the legislature, without full and adequate notice so that the public, patient groups, medical groups, and the Institute can participate fully. Jamming it through the Legislature by June 30 for a special election in November unnecessarily creates huge risks that unworkable language and provisions will make it impossible to carry out the mission of the Institute."
He also said, "Major portions of the language in SCA13 dealing with intellectual property would predictably create major legal problems and obstacles for the Institute in the development of therapies. It is vital that this constitutional amendment does not create major opportunities for litigation by the opposition to Prop. 71 that would paralyze the Institute."
Klein complained that the agency has not been fully heard because of legislative haste. "The scheduling of the hearings to date has not permitted the Institute to participate with the Senate in the development of solutions that would meet the common goals of the Institute and the Senate," he said.
The undue haste argument seems to echo that of cities in California seeking the headquarters location for CIRM. They too said a fast-track process impaired their abilities to do the best for the people of California, an argument rejected by Klein and the agency.
As for being unable to be heard by the legislature, Ortiz' concerns were well known last year, shortly after last fall's election. She introduced SCA13 more than two months ago, the same week Klein refused to appear before a special joint Assembly-Senate committee hearing on the agency (see "Stiffing Lawmakers" March 10 and "Roiling Undercurrents" March 16 on this blog).
SCA13 is expected to go through three legislative hearings in Assembly, assuming the likelihood of Senate passage. That will allow ample time for more input from CIRM and other parties.
Here are links to stories this morning on the proposal: Carl Hall, San Francisco Chronicle; Terri Somers, San Diego Union Tribune; Sandy Kleffman, Contra Costa Times. The Los Angeles Times and The Sacramento Bee did not appear to have stories this morning.
In a statement on CIRM's web site, he declared, "There does not appear to be any compelling reason that this constitutional amendment should be rushed through the legislature, without full and adequate notice so that the public, patient groups, medical groups, and the Institute can participate fully. Jamming it through the Legislature by June 30 for a special election in November unnecessarily creates huge risks that unworkable language and provisions will make it impossible to carry out the mission of the Institute."
He also said, "Major portions of the language in SCA13 dealing with intellectual property would predictably create major legal problems and obstacles for the Institute in the development of therapies. It is vital that this constitutional amendment does not create major opportunities for litigation by the opposition to Prop. 71 that would paralyze the Institute."
Klein complained that the agency has not been fully heard because of legislative haste. "The scheduling of the hearings to date has not permitted the Institute to participate with the Senate in the development of solutions that would meet the common goals of the Institute and the Senate," he said.
The undue haste argument seems to echo that of cities in California seeking the headquarters location for CIRM. They too said a fast-track process impaired their abilities to do the best for the people of California, an argument rejected by Klein and the agency.
As for being unable to be heard by the legislature, Ortiz' concerns were well known last year, shortly after last fall's election. She introduced SCA13 more than two months ago, the same week Klein refused to appear before a special joint Assembly-Senate committee hearing on the agency (see "Stiffing Lawmakers" March 10 and "Roiling Undercurrents" March 16 on this blog).
SCA13 is expected to go through three legislative hearings in Assembly, assuming the likelihood of Senate passage. That will allow ample time for more input from CIRM and other parties.
Here are links to stories this morning on the proposal: Carl Hall, San Francisco Chronicle; Terri Somers, San Diego Union Tribune; Sandy Kleffman, Contra Costa Times. The Los Angeles Times and The Sacramento Bee did not appear to have stories this morning.
Not For Everybody: Details of CIRM's Analysis of SCA13
The California stem cell agency has prepared a detailed and strong critique of the proposed ballot measure to tighten oversight of its activities.
The eight-page memo, however, was not generally made available to the public and only circulated to the handful of persons at Monday's meeting of the Oversight Committee. It is not available on agency's web site as of this writing despite the fact that legislation was a major topic for the stem cell panel.
While the analysis treads some familiar ground for those following the issue closely, it is the first full-blown public explanation of CIRM's position that we have seen. Particularly interesting are areas that deal with compensation to the state for products developed as a result of state-financed research.
The analysis says, "While it is reasonable – and required in Prop. 71 -- to ask that an intellectual property agreement is part of any Institute grant, it is naïve to believe that a level can be set for those revenue streams and may actually decrease the amount the state would get in the long run."
The document also deals in some detail with the peer review issue – whether it should be public and to what degree.
Arguing for private sessions, citing fears that scientists would be worried about damage to their reputations, the document says, "The public and the press cannot be expected to understand the differences between extreme criticism on one proposal and the extraordinary ability of the scientist or physician for break-through research in numerous other scientific specialty areas."
That is an interesting argument to make by an agency that says that the same, understanding-impaired public has spoken so wisely on Prop. 71 that no further changes should be made in it.
Since the memo was written, the proposed ballot measure in question, SCA13 by Sen. Deborah Ortiz, D-Sacramento, has been amended to deal with some of the objections raised in the analysis.
We learned of the document on Tuesday through a very brief mention in one of the news stories about Monday's Oversight Committee meeting. At that point, we asked the CIRM public information office for a copy. The response was that they were not aware of the analysis. We followed up with additional inquiries that were turned aside. On Thursday afternoon, CIRM supplied the document after we indicated we had it from another source. The explanation was that there had been a misunderstanding.
Regardless, it would seem to be in CIRM's best interests to make its own, rather effective analysis of legislation available to the public on its web site.
The full text of the memo follows in the item below.
The eight-page memo, however, was not generally made available to the public and only circulated to the handful of persons at Monday's meeting of the Oversight Committee. It is not available on agency's web site as of this writing despite the fact that legislation was a major topic for the stem cell panel.
While the analysis treads some familiar ground for those following the issue closely, it is the first full-blown public explanation of CIRM's position that we have seen. Particularly interesting are areas that deal with compensation to the state for products developed as a result of state-financed research.
The analysis says, "While it is reasonable – and required in Prop. 71 -- to ask that an intellectual property agreement is part of any Institute grant, it is naïve to believe that a level can be set for those revenue streams and may actually decrease the amount the state would get in the long run."
The document also deals in some detail with the peer review issue – whether it should be public and to what degree.
Arguing for private sessions, citing fears that scientists would be worried about damage to their reputations, the document says, "The public and the press cannot be expected to understand the differences between extreme criticism on one proposal and the extraordinary ability of the scientist or physician for break-through research in numerous other scientific specialty areas."
That is an interesting argument to make by an agency that says that the same, understanding-impaired public has spoken so wisely on Prop. 71 that no further changes should be made in it.
Since the memo was written, the proposed ballot measure in question, SCA13 by Sen. Deborah Ortiz, D-Sacramento, has been amended to deal with some of the objections raised in the analysis.
We learned of the document on Tuesday through a very brief mention in one of the news stories about Monday's Oversight Committee meeting. At that point, we asked the CIRM public information office for a copy. The response was that they were not aware of the analysis. We followed up with additional inquiries that were turned aside. On Thursday afternoon, CIRM supplied the document after we indicated we had it from another source. The explanation was that there had been a misunderstanding.
Regardless, it would seem to be in CIRM's best interests to make its own, rather effective analysis of legislation available to the public on its web site.
The full text of the memo follows in the item below.
Text of CIRM Analysis of SCA13
SCA 13 (Ortiz/Runner) Analysis
As of May 20, 2005
Summary: SCA 13 is a proposed California Constitutional amendment, which would change the California Stem Cell Research & Cures Act (Proposition 71) in three key areas: (1) open meetings; (3) financial issues related to intellectual property like return on investment and revenue sharing, and (1) conflict of interest for Independent Citizens’ Oversight Committee (ICOC) members, California Institute for Regenerative Medicine (CIRM) employees, and Working Group members.
Process to qualify for ballot: SCA 13 requires a 2/3 vote in both the state Senate and Assembly to appear on the next state ballot that occurs at least 131 days after passage by the Legislature. If the Governor calls a special election for November (the likely date would be November 8), the Legislature would need approval by June 30, unless a bill signed by the Governor extends the qualification date.
Part 1: Open Meetings
Current law on open meetings as provided in Proposition 71:
• Applies the Bagley Keene Open Meeting Act to meetings of the ICOC, with exceptions, and requires the ICOC to award all grants, loans, and contracts in public meetings, as well as all governance, scientific, medical, and regulatory standards. Since its first regular business meeting on January 6th, 29 public meetings of the ICOC and committees have been held.
• Allows the ICOC to conduct closed sessions as permitted by the Bagley Keene Act, as well as to consider matters involving information relating to patients or medical subjects, disclosure of which would compromise personal privacy; matters involving confidential intellectual property or work products of various kinds; matters involving pre-publication, confidential scientific research or data; and matters involving personnel matters.
• Provides that the California Public Records Act applies to all records of the ICOC, except as otherwise provided in the Act, with exemptions for records pertaining to patients or medical subjects, disclosure of which would compromise personal privacy; matters involving confidential intellectual property or work products of various kinds; matters involving pre-publication, confidential scientific research or data; and matters involving personnel matters.
• Provides that ICOC advisory working groups are not subject to open meeting laws, but provides that records the working groups submit as part of their recommendations to the ICOC shall be subject to the Public Records Act. This allows for confidential peer review of grant proposals.
SCA 13 Analysis
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Open Meetings – SCA 13 amends the State Constitution to require that records and meetings of the Working Groups be governed by open meeting and public record laws with certain exceptions to protect intellectual property and confidential or proprietary information.
SCA 13 proposes:
That Section 8 is added to Article XXXV thereof, to read:
SEC. 8.
b) (1) Except as provided in paragraph (2), meetings and records of the institute, the ICOC, or any body established to govern the institute, and any working or advisory group, are subject to California open meeting and public record laws that are applicable to state agencies.
(2) Notwithstanding paragraph (1), the ICOC, any body established to govern the institute, and any working group or advisory group, may conduct a closed session for the purpose of considering or discussing matters involving intellectual property or proprietary information and matters involving prepublication confidential scientific information associated with individual research proposals submitted for funding.
Concerns:
1. No recognition of necessity for confidential peer review in proposal. While elements of peer review are noted in the exceptions, clear language to protect the confidentiality of the entire grant evaluation process needs to be recognized. The rigor of the scientific review process will be compromised significantly if the Grants and Facilities Working Groups are prevented from reviewing proposals in private meetings. It is the standard and uniform practice of public (e.g., NIH and UC Special Research Program) and private funding agencies (e.g., American Cancer Society, American Heart Association, Juvenile Diabetes Research Foundation, National MS Society), and widely accepted in the scientific community, to conduct scientific peer review of grant applications in private. Requiring such meetings to be conducted in public would compromise and discourage the critical discourse and analysis necessary to ensure rigorous scientific review. This will also discourage applicants from sharing with the Working Group details of proposed projects that might include proprietary or unpublished results. Such details can make or break a grant proposal. For example, in analyzing any grant, part of the process is looking at scientific research history and academic reputation of the scientist or physician. Peer reviewers look at the potential grantee’s record – whether the scientist or physician achieved what he or she claimed to achieve in previous projects. They will also critically review whether the scientist or physician has the specific technical/scientific knowledge and research staff to accomplish the specific grant proposal. While the scientist or physician may be brilliant in a specific technical sub-area of the science, they may be subject to devastating criticism as to adequacy of their knowledge of the specific scientific specialties required for the grant application under consideration. For scientists or physicians who dedicate their lives to treating chronic diseases, being criticized publicly could jeopardize
SCA 13 Analysis
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his or her reputation and credibility, permanently damaging their career and ability to carry out future life-saving research in medical therapies. The public and the press cannot be expected to understand the differences between extreme criticism on one proposal and the extraordinary ability of the scientist or physician for break-through research in numerous other scientific specialty areas. If a scientist or physician is criticized as having major deficiencies in a proposed experiment, generally it is believed that they public will conclude that the scientist is incompetent; the public will not research the person’s entire career and realize that 95 percent of their work has been an incredible contribution to the advancement of therapies for chronic disease. This is why peer review has to be conducted confidentially. The National Institute of Health, the University of California System-statewide, and all major patient funded foundations for medical research, just to name a few organizations, all consistently maintain a confidential peer review process for these reasons.
2. Negatively impact Working Group membership. We will not be able to get candid and critical review to invest the public’s money in the best research. We will not get the best proposal submitted, and we will not get the best review in a public environment. We believe a public meeting requirement for scientific peer review meetings of Working Groups will discourage potential reviewers from joining the Working Groups.
Part 2: Intellectual Property
Current law on intellectual property as provided in Proposition 71:
• Requires the ICOC to establish standards that require all Proposition 71 grants and loans to be subject to intellectual property agreements that balance the opportunity of the state to benefit from the licenses, patents, and royalties that result from basic research, therapy development, and clinical trials with the need to ensure that essential medical research is not unreasonably hindered by the intellectual property agreements.
Intellectual Property and treatment access – SCA 13 amends the California Constitution to require that contracts, awards, grants, or loans entered into by any state entity that provides state funding for research funded by the Institute comply with specified criteria, including that they do not result in a gift of public funds; that any clinical treatments, products, or services resulting from funded research are made available at affordable costs to low-income residents; that the State recoup legal and administrative costs associated with patenting and licensing agreements; and that the State receives a share of royalties or revenues commensurate with its role in the development of the clinical treatments, products, or services.
SCA 13 proposes:
First – That Section 6 of Article XXXV thereof is amended to read, to read:
SEC. 6. Except as otherwise provided in this article, notwithstanding any other provision of this Constitution or
SCA 13 Analysis
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any law, the institute, which is established in state government, may utilize state issued tax-exempt and taxable bonds to fund its operations, medical and scientific research, including therapy development through clinical trials, and facilities.
Concerns:
3. Likely legal challenges – The phrase “except as otherwise provided” in Section 6 opens an avenue for legal challenges based upon procedural arguments that will disrupt the financing of meritorious research. SCA 13 is being advanced with ambiguous language and no serious implementation plan. Proposition 71 was carefully written with the involvement of three separate law firms and based upon case law research to avoid the constant litigation that would be likely should SCA 13 become law as written. The legal battles could paralyze the Institute’s mission for years to come. As the Senate Elections consultant wrote in his analysis: “[SCA 13] is somewhat unorthodox in that instead of amending the statutory language dealing with the open meeting, conflict-of-interest, and other requirements that Proposition 71 added to the codes, it asks voters to make those changes by amending the Constitution. While amending the Constitution isn’t uncommon, the author and committee may wish to consider whether it would be more appropriate to, instead of asking the voters to place into the Constitution language aimed at providing more specificity to a statutory initiative, ask the voters to amend the initiative itself.” He continues: “While the language of Proposition 71 precludes the Legislature from amending the measure until 2008, there is no restriction on putting another measure on the ballot that would ask the voters if they want to amend Proposition 71.”
SCA 13 proposes:
That Section 9 is added to Article XXXV thereof, to read:
SEC. 9.
(a) Every contract, award, grant, loan, or other arrangement entered into by the institute or the Independent Citizen's Oversight Committee that provides state funding or other resources, shall ensure all of the following:
(1) Notwithstanding Section 6, the contract, award, grant, loan, or other arrangement does not result in a gift of public funds within the meaning of Section 6 of Article XVI.
(2) All clinical treatments, products, or services resulting from the biomedical research are made available at the costs of producing them to California residents who are eligible to receive assistance through state and county health care and preventive health programs including, but not limited to, the Medi-Cal and Healthy Families programs.
Concerns:
4. Discourages private sector involvement -- While well-intentioned, these provisions could have a host of unfortunate and unintended consequences, including discouraging industry from involvement with the Institute. Private industry is a critical partner in developing scientific discoveries into safe and
SCA 13 Analysis
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effective drugs and treatments that benefit the public. If an affordable drug-pricing requirement or a revenue sharing requirement were to discourage industry from participating in technology transfer, it would be to the detriment of the public health and well being.
5. Ignores legislative processes – As previously noted, the ICOC is cooperating with the California Council on Science and Technology to study how the state should treat intellectual property made under state contracts, grants, and agreements, as requested by ACR 252 (Mullin) in the 2003-04 session. This study group is currently meeting and anticipates having a report to the Legislature by July, 2005. SCA 13 ignores the legislative process and preempts the work of experts in this field.
6. Gifting prohibition – The prohibition on gifting may affect the Institute’s ability to provide training grants.
SCA 13 proposes:
(3) The terms of any loan, lease, or rental arrangement are consistent with, or below, market rates for rent or interest.
(4) The State recoups the full amount of its legal and administrative costs incurred with respect to patenting and licensing activities related to the biomedical research.
Concerns:
7. No State patenting costs – Section 9(a)(4) provides that the State will recoup legal and administrative costs related to patents and licensing. These costs are borne by the grantee institution, not the State. This clause is superfluous, as the State will not incur these administrative and legal costs.
SCA 13 proposes:
(5) The State is provided a share of the royalties or revenues, derived from the development of clinical treatments, products, or services resulting from the research, that is sufficient to repay its expenses incurred in developing the clinical treatments, products, or services.
Concerns:
8. Lack of clarity in language -- The provision stating "The State is provided a share or the royalties or revenues, derived from the development or treatment of clinical treatments, products, or services resulting from the research, that is sufficient to repay its expenses incurred in developing the clinical treatments, products or services" is problematic. The word "develop" has a specific meaning in the biotech and pharma industry and the State will not likely be engaging in these activities because they are both expensive and risky, which raises the question of what this provision even means and thus how it would be implemented. Furthermore, calculating intellectual property formulas setting forth mechanisms for shares of revenue does not belong in the Constitution. As the Senate Elections Committee consultant wrote in his analysis: “While ensuring the taxpayers are
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fully reimbursed for their costs, this measure doesn’t impose any limits on what those costs can be. The author and committee may wish to consider whether such a limit is appropriate or feasible.”
SCA 13 proposes:
(6) In addition to royalties or licensing revenues described in paragraph (5), royalties or licensing revenues are transmitted to the State in an amount sufficient to repay any costs of issuing bonds incurred by the State in funding the biomedical research.
Concerns:
9. Revenue levels -- It is not clear how agreements would be structured so that the State received royalties sufficient to repay costs associated with issuing the bonds. While it is reasonable – and required in Proposition 71 -- to ask that an intellectual property agreement is part of any Institute grant, it is naïve to believe that a level can be set for those revenue streams and may actually decrease the amount the state would get in the long run. A typical structure for sharing revenue streams is to require a certain percentage.
10. Effect on tax exempt status on bonds – If the State has a right to share in royalties, even if it is only in an amount that recovers the State’s costs, the transfers to the research entities will not be treated as grants, resulting in tax-exempt questions.
Part 3: Conflict of Interest
Current law on conflict as interest as provided in Proposition 71:
• Applies the Political Reform Act to the Institute staff and members of the ICOC, with certain modifications. This means that all board members and staff must file a statement of economic interests (Form 700).
• Allows a member of the ICOC to participate in a decision to approve or award a grant, loan, or contract to a non-profit entity in the same field as his or her employer.
• Allows an ICOC member to participate in awarding a grant, loan, or contract for purposes of research involving a disease from which the member or an immediate family member suffers from or which the member has an interest in as a representative of a disease advocacy organization.
• Provides that service as a member of the ICOC shall not be deemed incompatible with service as a faculty member or administrator of the University of California, representative or employee of a disease advocacy organization, a nonprofit academic research institution, or a life science commercial entity.
• Provides that ICOC working group members are not subject to the Political Reform Act and instead, subjects them to conflict of interest rules to be adopted by the ICOC, which shall be based on standards applicable to members of scientific review committees of the National Institutes of Health (NIH). The ICOC has adopted strong conflict of interest policies for the ICOC, employees, and
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working group members. All policies are accessible to the public on www.cirm.ca.gov.
Conflict of Interest – SCA 13 requires two levels of compliance with conflict of interest – financial disclosure and divestment or blind trust depending upon role with the work of the Institute. The chair and vice chair and any appointed member of the Independent Citizen's Oversight Committee (ICOC), the Institute president, and any member of any working or advisory group appointed to assist the Institute or its governing body must disclose his or her income, investments, and interests in real property. The chair and vice chair and ICOC members, the Institute president must divest of or place into a blind trust, any financial or real property interest held in any organization that applies for funding from, or contracts with, the Institute or in any organization with a substantial interest in stem cell therapy. An organization with a substantial interest in stem cell therapy is defined as one that has more than five percent of the organization’s current annual research budget is allocated to stem cell therapy, based upon publicly available information.
SCA 13 proposes:
Section 8 is added to Article XXXV thereof, to read:
SEC. 8.
(a) The chair and vice chair and any appointed member of the Independent Citizen's Oversight Committee (ICOC), the president and each employee of the institute, and any member of any working or advisory group appointed to assist the institute or its governing body shall disclose his or her income, investments, and interests in real property in the manner set forth in Chapter 7 (commencing with Section 87100) of Title 9 of the Government Code, or its successor. The chair and vice chair and any appointed member of the ICOC, the president of the institute or its governing body shall divest themselves of or place into a blind trust, any financial or real property interest held by that person in any organization that applies for funding from, or contracts with, the institute or in any organization with a substantial interest in stem cell therapy. An organization with a substantial interest in stem cell therapy is one for which, based upon publicly available information, more than five percent of the organization’s current annual research budget is allocated to stem cell therapy.
Concerns:
11. This amendment would subject members of the Working Groups to the Political Reform Act’s conflict of interest provisions, including disclosure of investments, income, gifts, travel payments and real property through the filing of Form 700. This information would be subject to public disclosure. The divestment provision puts a greater onus on ICOC members and the president than is imposed on any other state official. CIRM Working Groups are advisory, not decision-making bodies and Working Group members are not employees of CIRM. COI policies for Working Group members should recognize this important but limited role.
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This provision would negatively impact the Institute’s ability to recruit and retain leading scientists and clinicians for the ICOC and the Working Groups. We are concerned that anyone who is a member of an ad hoc advisory group would need to disclosure without regards to the nature of their work or focus area. This may impede the Institute from taking advantage of volunteer expertise.
As of May 20, 2005
Summary: SCA 13 is a proposed California Constitutional amendment, which would change the California Stem Cell Research & Cures Act (Proposition 71) in three key areas: (1) open meetings; (3) financial issues related to intellectual property like return on investment and revenue sharing, and (1) conflict of interest for Independent Citizens’ Oversight Committee (ICOC) members, California Institute for Regenerative Medicine (CIRM) employees, and Working Group members.
Process to qualify for ballot: SCA 13 requires a 2/3 vote in both the state Senate and Assembly to appear on the next state ballot that occurs at least 131 days after passage by the Legislature. If the Governor calls a special election for November (the likely date would be November 8), the Legislature would need approval by June 30, unless a bill signed by the Governor extends the qualification date.
Part 1: Open Meetings
Current law on open meetings as provided in Proposition 71:
• Applies the Bagley Keene Open Meeting Act to meetings of the ICOC, with exceptions, and requires the ICOC to award all grants, loans, and contracts in public meetings, as well as all governance, scientific, medical, and regulatory standards. Since its first regular business meeting on January 6th, 29 public meetings of the ICOC and committees have been held.
• Allows the ICOC to conduct closed sessions as permitted by the Bagley Keene Act, as well as to consider matters involving information relating to patients or medical subjects, disclosure of which would compromise personal privacy; matters involving confidential intellectual property or work products of various kinds; matters involving pre-publication, confidential scientific research or data; and matters involving personnel matters.
• Provides that the California Public Records Act applies to all records of the ICOC, except as otherwise provided in the Act, with exemptions for records pertaining to patients or medical subjects, disclosure of which would compromise personal privacy; matters involving confidential intellectual property or work products of various kinds; matters involving pre-publication, confidential scientific research or data; and matters involving personnel matters.
• Provides that ICOC advisory working groups are not subject to open meeting laws, but provides that records the working groups submit as part of their recommendations to the ICOC shall be subject to the Public Records Act. This allows for confidential peer review of grant proposals.
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Open Meetings – SCA 13 amends the State Constitution to require that records and meetings of the Working Groups be governed by open meeting and public record laws with certain exceptions to protect intellectual property and confidential or proprietary information.
SCA 13 proposes:
That Section 8 is added to Article XXXV thereof, to read:
SEC. 8.
b) (1) Except as provided in paragraph (2), meetings and records of the institute, the ICOC, or any body established to govern the institute, and any working or advisory group, are subject to California open meeting and public record laws that are applicable to state agencies.
(2) Notwithstanding paragraph (1), the ICOC, any body established to govern the institute, and any working group or advisory group, may conduct a closed session for the purpose of considering or discussing matters involving intellectual property or proprietary information and matters involving prepublication confidential scientific information associated with individual research proposals submitted for funding.
Concerns:
1. No recognition of necessity for confidential peer review in proposal. While elements of peer review are noted in the exceptions, clear language to protect the confidentiality of the entire grant evaluation process needs to be recognized. The rigor of the scientific review process will be compromised significantly if the Grants and Facilities Working Groups are prevented from reviewing proposals in private meetings. It is the standard and uniform practice of public (e.g., NIH and UC Special Research Program) and private funding agencies (e.g., American Cancer Society, American Heart Association, Juvenile Diabetes Research Foundation, National MS Society), and widely accepted in the scientific community, to conduct scientific peer review of grant applications in private. Requiring such meetings to be conducted in public would compromise and discourage the critical discourse and analysis necessary to ensure rigorous scientific review. This will also discourage applicants from sharing with the Working Group details of proposed projects that might include proprietary or unpublished results. Such details can make or break a grant proposal. For example, in analyzing any grant, part of the process is looking at scientific research history and academic reputation of the scientist or physician. Peer reviewers look at the potential grantee’s record – whether the scientist or physician achieved what he or she claimed to achieve in previous projects. They will also critically review whether the scientist or physician has the specific technical/scientific knowledge and research staff to accomplish the specific grant proposal. While the scientist or physician may be brilliant in a specific technical sub-area of the science, they may be subject to devastating criticism as to adequacy of their knowledge of the specific scientific specialties required for the grant application under consideration. For scientists or physicians who dedicate their lives to treating chronic diseases, being criticized publicly could jeopardize
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his or her reputation and credibility, permanently damaging their career and ability to carry out future life-saving research in medical therapies. The public and the press cannot be expected to understand the differences between extreme criticism on one proposal and the extraordinary ability of the scientist or physician for break-through research in numerous other scientific specialty areas. If a scientist or physician is criticized as having major deficiencies in a proposed experiment, generally it is believed that they public will conclude that the scientist is incompetent; the public will not research the person’s entire career and realize that 95 percent of their work has been an incredible contribution to the advancement of therapies for chronic disease. This is why peer review has to be conducted confidentially. The National Institute of Health, the University of California System-statewide, and all major patient funded foundations for medical research, just to name a few organizations, all consistently maintain a confidential peer review process for these reasons.
2. Negatively impact Working Group membership. We will not be able to get candid and critical review to invest the public’s money in the best research. We will not get the best proposal submitted, and we will not get the best review in a public environment. We believe a public meeting requirement for scientific peer review meetings of Working Groups will discourage potential reviewers from joining the Working Groups.
Part 2: Intellectual Property
Current law on intellectual property as provided in Proposition 71:
• Requires the ICOC to establish standards that require all Proposition 71 grants and loans to be subject to intellectual property agreements that balance the opportunity of the state to benefit from the licenses, patents, and royalties that result from basic research, therapy development, and clinical trials with the need to ensure that essential medical research is not unreasonably hindered by the intellectual property agreements.
Intellectual Property and treatment access – SCA 13 amends the California Constitution to require that contracts, awards, grants, or loans entered into by any state entity that provides state funding for research funded by the Institute comply with specified criteria, including that they do not result in a gift of public funds; that any clinical treatments, products, or services resulting from funded research are made available at affordable costs to low-income residents; that the State recoup legal and administrative costs associated with patenting and licensing agreements; and that the State receives a share of royalties or revenues commensurate with its role in the development of the clinical treatments, products, or services.
SCA 13 proposes:
First – That Section 6 of Article XXXV thereof is amended to read, to read:
SEC. 6. Except as otherwise provided in this article, notwithstanding any other provision of this Constitution or
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any law, the institute, which is established in state government, may utilize state issued tax-exempt and taxable bonds to fund its operations, medical and scientific research, including therapy development through clinical trials, and facilities.
Concerns:
3. Likely legal challenges – The phrase “except as otherwise provided” in Section 6 opens an avenue for legal challenges based upon procedural arguments that will disrupt the financing of meritorious research. SCA 13 is being advanced with ambiguous language and no serious implementation plan. Proposition 71 was carefully written with the involvement of three separate law firms and based upon case law research to avoid the constant litigation that would be likely should SCA 13 become law as written. The legal battles could paralyze the Institute’s mission for years to come. As the Senate Elections consultant wrote in his analysis: “[SCA 13] is somewhat unorthodox in that instead of amending the statutory language dealing with the open meeting, conflict-of-interest, and other requirements that Proposition 71 added to the codes, it asks voters to make those changes by amending the Constitution. While amending the Constitution isn’t uncommon, the author and committee may wish to consider whether it would be more appropriate to, instead of asking the voters to place into the Constitution language aimed at providing more specificity to a statutory initiative, ask the voters to amend the initiative itself.” He continues: “While the language of Proposition 71 precludes the Legislature from amending the measure until 2008, there is no restriction on putting another measure on the ballot that would ask the voters if they want to amend Proposition 71.”
SCA 13 proposes:
That Section 9 is added to Article XXXV thereof, to read:
SEC. 9.
(a) Every contract, award, grant, loan, or other arrangement entered into by the institute or the Independent Citizen's Oversight Committee that provides state funding or other resources, shall ensure all of the following:
(1) Notwithstanding Section 6, the contract, award, grant, loan, or other arrangement does not result in a gift of public funds within the meaning of Section 6 of Article XVI.
(2) All clinical treatments, products, or services resulting from the biomedical research are made available at the costs of producing them to California residents who are eligible to receive assistance through state and county health care and preventive health programs including, but not limited to, the Medi-Cal and Healthy Families programs.
Concerns:
4. Discourages private sector involvement -- While well-intentioned, these provisions could have a host of unfortunate and unintended consequences, including discouraging industry from involvement with the Institute. Private industry is a critical partner in developing scientific discoveries into safe and
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effective drugs and treatments that benefit the public. If an affordable drug-pricing requirement or a revenue sharing requirement were to discourage industry from participating in technology transfer, it would be to the detriment of the public health and well being.
5. Ignores legislative processes – As previously noted, the ICOC is cooperating with the California Council on Science and Technology to study how the state should treat intellectual property made under state contracts, grants, and agreements, as requested by ACR 252 (Mullin) in the 2003-04 session. This study group is currently meeting and anticipates having a report to the Legislature by July, 2005. SCA 13 ignores the legislative process and preempts the work of experts in this field.
6. Gifting prohibition – The prohibition on gifting may affect the Institute’s ability to provide training grants.
SCA 13 proposes:
(3) The terms of any loan, lease, or rental arrangement are consistent with, or below, market rates for rent or interest.
(4) The State recoups the full amount of its legal and administrative costs incurred with respect to patenting and licensing activities related to the biomedical research.
Concerns:
7. No State patenting costs – Section 9(a)(4) provides that the State will recoup legal and administrative costs related to patents and licensing. These costs are borne by the grantee institution, not the State. This clause is superfluous, as the State will not incur these administrative and legal costs.
SCA 13 proposes:
(5) The State is provided a share of the royalties or revenues, derived from the development of clinical treatments, products, or services resulting from the research, that is sufficient to repay its expenses incurred in developing the clinical treatments, products, or services.
Concerns:
8. Lack of clarity in language -- The provision stating "The State is provided a share or the royalties or revenues, derived from the development or treatment of clinical treatments, products, or services resulting from the research, that is sufficient to repay its expenses incurred in developing the clinical treatments, products or services" is problematic. The word "develop" has a specific meaning in the biotech and pharma industry and the State will not likely be engaging in these activities because they are both expensive and risky, which raises the question of what this provision even means and thus how it would be implemented. Furthermore, calculating intellectual property formulas setting forth mechanisms for shares of revenue does not belong in the Constitution. As the Senate Elections Committee consultant wrote in his analysis: “While ensuring the taxpayers are
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fully reimbursed for their costs, this measure doesn’t impose any limits on what those costs can be. The author and committee may wish to consider whether such a limit is appropriate or feasible.”
SCA 13 proposes:
(6) In addition to royalties or licensing revenues described in paragraph (5), royalties or licensing revenues are transmitted to the State in an amount sufficient to repay any costs of issuing bonds incurred by the State in funding the biomedical research.
Concerns:
9. Revenue levels -- It is not clear how agreements would be structured so that the State received royalties sufficient to repay costs associated with issuing the bonds. While it is reasonable – and required in Proposition 71 -- to ask that an intellectual property agreement is part of any Institute grant, it is naïve to believe that a level can be set for those revenue streams and may actually decrease the amount the state would get in the long run. A typical structure for sharing revenue streams is to require a certain percentage.
10. Effect on tax exempt status on bonds – If the State has a right to share in royalties, even if it is only in an amount that recovers the State’s costs, the transfers to the research entities will not be treated as grants, resulting in tax-exempt questions.
Part 3: Conflict of Interest
Current law on conflict as interest as provided in Proposition 71:
• Applies the Political Reform Act to the Institute staff and members of the ICOC, with certain modifications. This means that all board members and staff must file a statement of economic interests (Form 700).
• Allows a member of the ICOC to participate in a decision to approve or award a grant, loan, or contract to a non-profit entity in the same field as his or her employer.
• Allows an ICOC member to participate in awarding a grant, loan, or contract for purposes of research involving a disease from which the member or an immediate family member suffers from or which the member has an interest in as a representative of a disease advocacy organization.
• Provides that service as a member of the ICOC shall not be deemed incompatible with service as a faculty member or administrator of the University of California, representative or employee of a disease advocacy organization, a nonprofit academic research institution, or a life science commercial entity.
• Provides that ICOC working group members are not subject to the Political Reform Act and instead, subjects them to conflict of interest rules to be adopted by the ICOC, which shall be based on standards applicable to members of scientific review committees of the National Institutes of Health (NIH). The ICOC has adopted strong conflict of interest policies for the ICOC, employees, and
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working group members. All policies are accessible to the public on www.cirm.ca.gov.
Conflict of Interest – SCA 13 requires two levels of compliance with conflict of interest – financial disclosure and divestment or blind trust depending upon role with the work of the Institute. The chair and vice chair and any appointed member of the Independent Citizen's Oversight Committee (ICOC), the Institute president, and any member of any working or advisory group appointed to assist the Institute or its governing body must disclose his or her income, investments, and interests in real property. The chair and vice chair and ICOC members, the Institute president must divest of or place into a blind trust, any financial or real property interest held in any organization that applies for funding from, or contracts with, the Institute or in any organization with a substantial interest in stem cell therapy. An organization with a substantial interest in stem cell therapy is defined as one that has more than five percent of the organization’s current annual research budget is allocated to stem cell therapy, based upon publicly available information.
SCA 13 proposes:
Section 8 is added to Article XXXV thereof, to read:
SEC. 8.
(a) The chair and vice chair and any appointed member of the Independent Citizen's Oversight Committee (ICOC), the president and each employee of the institute, and any member of any working or advisory group appointed to assist the institute or its governing body shall disclose his or her income, investments, and interests in real property in the manner set forth in Chapter 7 (commencing with Section 87100) of Title 9 of the Government Code, or its successor. The chair and vice chair and any appointed member of the ICOC, the president of the institute or its governing body shall divest themselves of or place into a blind trust, any financial or real property interest held by that person in any organization that applies for funding from, or contracts with, the institute or in any organization with a substantial interest in stem cell therapy. An organization with a substantial interest in stem cell therapy is one for which, based upon publicly available information, more than five percent of the organization’s current annual research budget is allocated to stem cell therapy.
Concerns:
11. This amendment would subject members of the Working Groups to the Political Reform Act’s conflict of interest provisions, including disclosure of investments, income, gifts, travel payments and real property through the filing of Form 700. This information would be subject to public disclosure. The divestment provision puts a greater onus on ICOC members and the president than is imposed on any other state official. CIRM Working Groups are advisory, not decision-making bodies and Working Group members are not employees of CIRM. COI policies for Working Group members should recognize this important but limited role.
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This provision would negatively impact the Institute’s ability to recruit and retain leading scientists and clinicians for the ICOC and the Working Groups. We are concerned that anyone who is a member of an ad hoc advisory group would need to disclosure without regards to the nature of their work or focus area. This may impede the Institute from taking advantage of volunteer expertise.
Thursday, May 26, 2005
SCA13 Wins Approval
A proposed ballot measure to tighten oversight of the California stem cell agency today advanced to the Senate floor, where it is expected to be debated next week.
The measure by Sen. Deborah Ortiz, D-Sacramento, was unanimously approved by the Senate Appropriations Committee.
Ortiz said, “This measure will ensure the state can continue to attract the best and brightest researchers and scientists while protecting the financial interests of the state as well as our goal to develop cures for debilitating and deadly diseases that affect more than 1 million Americans. We will continue working with members of the stem cell governing board to ensure the public’s confidence in and long-term support of this $3 billion publicly-funded research program is maintained.”
We are seeking comment from the stem cell agency.
The measure by Sen. Deborah Ortiz, D-Sacramento, was unanimously approved by the Senate Appropriations Committee.
Ortiz said, “This measure will ensure the state can continue to attract the best and brightest researchers and scientists while protecting the financial interests of the state as well as our goal to develop cures for debilitating and deadly diseases that affect more than 1 million Americans. We will continue working with members of the stem cell governing board to ensure the public’s confidence in and long-term support of this $3 billion publicly-funded research program is maintained.”
We are seeking comment from the stem cell agency.
Klein, Ortiz Agree on SCA 13 Changes, But Differences Remain
Stem cell chairman Robert Klein and Sen. Deborah Ortiz have reached "conceptual agreement" on modifications to her legislation to tighten oversight on the California stem cell agency.
Differences remain on important points, however. The full significance of the agreement could not be determined. As this item is being written, the proposed constitutional amendment, SCA 13, is being heard by the Senate Appropriations Committee. We are also seeking comment from the stem cell agency.
Here is a rundown on changes, as provided by her office.
Working group members would be required to disclose their economic interests in manner set forth in political reform act with disclosure to the Oversight Committee. Disclosure would be to the committee and not to the general public.
The committee would provide the state auditor with the disclosure statements. The state auditor would be required to annually review disclosure statements as well as decisions or recommendations of each working group member and report findings to the legislature regarding whether working group members have complied with requirements.
SCA 13 would adopt the NIH requirement that members must recuse themselves from deliberation on any proposal if they or a close relative or professional associate has a financial interest in the proposal, including a direct benefit of any type deriving from the proposal itself, or a financial benefit of any type from an applicant institution of over $5,000 per year, including honoraria, fees, stock, or other benefits.
Meetings of the Oversight Committee and the agency would be subject to open meeting laws.
Working groups would be allowed to conduct closed sessions to conduct peer review and to consider matters involving intellectual property, proprietary information, and prepublication scientific information.
Working groups would be required to produce a written summary of their reasons for funding or not funding any project as well as how each project recommended for funding will benefit California residents and to conduct an open public meeting to solicit public comments before submitting the recommendation to the Oversight Committee.
Unchanged would be provisions requiring that the grants and contracts ensure that the state receives a return on its investment in the form of access to low cost treatments, recoupment of legal and administrative costs, and a share of the royalties. Ortiz is continuing to look at language to address concerns that these provisions may impede the issuance of bonds, "a relatively technical fix," and that they may jeopardize
the tax exempt status of any bonds issued, according to her office.
Both Klein and Ortiz agree that the "state should receive some type of return on its investment in research and part of that return should be ensuring that stem cell therapies and treatments resulting from research funded by the state are affordable and accessible."
But they disagree, said her office, about the mechanism. Ortiz "wants to adopt the model used by the International AIDS Vaccine Initiative, which requires entities receiving funding to commit to make vaccines available at reasonable prices and in sufficient supplies. Mr. Klein believes the state could direct a portion of the royalty payments negotiated by the ICOC into programs or initiatives to promote access to low cost therapies. They agreed to conduct further research and seek legal opinions about the viability of each approach."
We hope to bring more details and information on this issue later in the day.
Differences remain on important points, however. The full significance of the agreement could not be determined. As this item is being written, the proposed constitutional amendment, SCA 13, is being heard by the Senate Appropriations Committee. We are also seeking comment from the stem cell agency.
Here is a rundown on changes, as provided by her office.
Oversight Committee members, chair and vice chair, and institute president would be required to disclose their economic interests in the manner set forth in the Political Reform Act. They would be required to divest or place in blind trust any financial or real property interest in any organization that applies for funding or that has substantial interests in stem cell therapy, defined as greater than 5 percent of its research budget.
Working group members would be required to disclose their economic interests in manner set forth in political reform act with disclosure to the Oversight Committee. Disclosure would be to the committee and not to the general public.
The committee would provide the state auditor with the disclosure statements. The state auditor would be required to annually review disclosure statements as well as decisions or recommendations of each working group member and report findings to the legislature regarding whether working group members have complied with requirements.
SCA 13 would adopt the NIH requirement that members must recuse themselves from deliberation on any proposal if they or a close relative or professional associate has a financial interest in the proposal, including a direct benefit of any type deriving from the proposal itself, or a financial benefit of any type from an applicant institution of over $5,000 per year, including honoraria, fees, stock, or other benefits.
Meetings of the Oversight Committee and the agency would be subject to open meeting laws.
Working groups would be allowed to conduct closed sessions to conduct peer review and to consider matters involving intellectual property, proprietary information, and prepublication scientific information.
Working groups would be required to produce a written summary of their reasons for funding or not funding any project as well as how each project recommended for funding will benefit California residents and to conduct an open public meeting to solicit public comments before submitting the recommendation to the Oversight Committee.
Unchanged would be provisions requiring that the grants and contracts ensure that the state receives a return on its investment in the form of access to low cost treatments, recoupment of legal and administrative costs, and a share of the royalties. Ortiz is continuing to look at language to address concerns that these provisions may impede the issuance of bonds, "a relatively technical fix," and that they may jeopardize
the tax exempt status of any bonds issued, according to her office.
Both Klein and Ortiz agree that the "state should receive some type of return on its investment in research and part of that return should be ensuring that stem cell therapies and treatments resulting from research funded by the state are affordable and accessible."
But they disagree, said her office, about the mechanism. Ortiz "wants to adopt the model used by the International AIDS Vaccine Initiative, which requires entities receiving funding to commit to make vaccines available at reasonable prices and in sufficient supplies. Mr. Klein believes the state could direct a portion of the royalty payments negotiated by the ICOC into programs or initiatives to promote access to low cost therapies. They agreed to conduct further research and seek legal opinions about the viability of each approach."
We hope to bring more details and information on this issue later in the day.
SCA 13: A Yeah and a Compromise
The big dog of California newspapers, the Los Angeles Times, has endorsed legislation that would tighten oversight of the California stem cell agency. Meanwhile, the politically influential Sacramento Bee has offered up a possible compromise on the measure, which is vehemently opposed by the agency.
Lives will be lost is the position of CIRM if the proposal by Sen. Deborah Ortiz, D-Sacramento, is passed. Ortiz supported creation of the agency and supports stem cell research. But she believes that the agency should be held to standards that generally apply to other state bureaucracies.
The Times, the largest circulation (900,000) newspaper in California, said that "leaders of the (stem cell agency) are engaging in inexcusable rhetoric. If enacted, said the institute's acting chief, the (Ortiz) amendment would 'cripple our efforts.' A board member said it would lead to 'extra suffering and death.'"
The Times continued, "It's understandable that companies and scientists would be unwilling in an open forum to discuss their or others' work related to possible contracts or disclose their patent applications. But SCA 13 makes broad allowances for such discussions to be private."
"From a purely pragmatic standpoint," the newspaper said, "(stem cell chairman Robert) Klein should welcome the constitutional amendment because it could insulate the institute from lawsuits alleging that the lack of public oversight had rendered the stem cell bonds unconstitutional."After all, this isn't Klein's or his board's $3 billion — it's the public's. And public oversight is one of the best ways to guard against public money going astray."
(We should note that the editor of the Times editorial page, Michael Kinsley, has Parkinson's, which many believe could be treated with future cures from stem cell research. It is unknown whether the Times' position on SCA 13 reflects his own.)
The Sacramento Bee, with 300,000 circulation in the Capitol, said:
"California's Legislature and the state's $3 billion stem cell research institute are engaged in a dangerous game of political chicken. No one will win if both keep careening toward the ballot box."
The compromise suggestion The Bee proferred dealt with whether the working group meetings of the agency should be public and whether assurances should be enacted to guarantee that stem cell cures would be available to low income persons.
The Bee said that "there is no reason these (working group) meetings need to be completely closed. Peer reviewers could easily hold open discussions on whether proposed research projects meet the institute's goals and criteria. Then they could move into private sessions to discuss the reputations and qualifications of applicants, consider patent issues and conduct the final scoring. This type of hybrid would help inform taxpayers (and the oversight board) about the projects they are financing, without discouraging candid discussions."
It also said, "A current draft of (Ortiz') measure requires that therapies be made available at cost 'to California residents who are eligible to receive assistance through state and county health care and preventive health programs.' Ortiz's intent is admirable, but this provision is premature. Scientists are still years away from full and final testing of embryonic stem cell therapies, and the institute's oversight board is many months away from discussing their eventual licensing. Lawmakers could easily wait two years before delving into this issue. At that point, they will have legal standing under Proposition 71 to amend the law without a constitutional amendment."
Lives will be lost is the position of CIRM if the proposal by Sen. Deborah Ortiz, D-Sacramento, is passed. Ortiz supported creation of the agency and supports stem cell research. But she believes that the agency should be held to standards that generally apply to other state bureaucracies.
The Times, the largest circulation (900,000) newspaper in California, said that "leaders of the (stem cell agency) are engaging in inexcusable rhetoric. If enacted, said the institute's acting chief, the (Ortiz) amendment would 'cripple our efforts.' A board member said it would lead to 'extra suffering and death.'"
The Times continued, "It's understandable that companies and scientists would be unwilling in an open forum to discuss their or others' work related to possible contracts or disclose their patent applications. But SCA 13 makes broad allowances for such discussions to be private."
"From a purely pragmatic standpoint," the newspaper said, "(stem cell chairman Robert) Klein should welcome the constitutional amendment because it could insulate the institute from lawsuits alleging that the lack of public oversight had rendered the stem cell bonds unconstitutional."After all, this isn't Klein's or his board's $3 billion — it's the public's. And public oversight is one of the best ways to guard against public money going astray."
(We should note that the editor of the Times editorial page, Michael Kinsley, has Parkinson's, which many believe could be treated with future cures from stem cell research. It is unknown whether the Times' position on SCA 13 reflects his own.)
The Sacramento Bee, with 300,000 circulation in the Capitol, said:
"California's Legislature and the state's $3 billion stem cell research institute are engaged in a dangerous game of political chicken. No one will win if both keep careening toward the ballot box."
The compromise suggestion The Bee proferred dealt with whether the working group meetings of the agency should be public and whether assurances should be enacted to guarantee that stem cell cures would be available to low income persons.
The Bee said that "there is no reason these (working group) meetings need to be completely closed. Peer reviewers could easily hold open discussions on whether proposed research projects meet the institute's goals and criteria. Then they could move into private sessions to discuss the reputations and qualifications of applicants, consider patent issues and conduct the final scoring. This type of hybrid would help inform taxpayers (and the oversight board) about the projects they are financing, without discouraging candid discussions."
It also said, "A current draft of (Ortiz') measure requires that therapies be made available at cost 'to California residents who are eligible to receive assistance through state and county health care and preventive health programs.' Ortiz's intent is admirable, but this provision is premature. Scientists are still years away from full and final testing of embryonic stem cell therapies, and the institute's oversight board is many months away from discussing their eventual licensing. Lawmakers could easily wait two years before delving into this issue. At that point, they will have legal standing under Proposition 71 to amend the law without a constitutional amendment."
Wednesday, May 25, 2005
Dodging the Two-Thirds Bullet
You might call it the stem cell work-around. It is a way to fast track a tough stem cell oversight proposal onto the November ballot.
The tactic would avoid Sen. Deborah Ortiz' nasty problem of securing a two-thirds vote in both houses of the California legislature for her proposed constitutional amendment on the California stem cell agency.
That is a difficult task under the best of circumstances. Two-thirds approval means that members of both parties have to vote for a proposal. The requirement has been one of the main reasons for the yearly budget gridlock in Sacramento. While Ortiz' measure (SCA13) has bipartisan support, it is unclear whether that is sufficient to deliver all the votes she needs. Her task is even trickier given the timetable for placing a measure on the ballot. Normally the proposal would have to clear both houses by the end of June.
Now comes a little noticed comment in one legislative analysis of SCA13 from the Elections, Reapportionment and Constitutional Amendments Committee, which approved the measure earlier.
The analysis suggested that "the author and committee may wish to consider whether it would be more appropriate to, instead of asking the voters to place into the Constitution language aimed at providing more specificity to a statutory initiative, ask the voters to amend the initiative itself."
That would require a simple majority vote in both houses, the analysis said. But it would also require the governor's signature while a constitutional amendment does not.
There is no indication whether Ortiz is considering making such a change in her legislation.
Ortiz has scheduled a news conference call for noon Thursday (May 26). SCA13 comes up in the Senate Appropriations Committee later that afternoon. Ortiz also met with Robert Klein Wednesday to exchange views about the proposal, which the stem cell Oversight Committee unanimously opposed on Monday.
For the record, the committee analysis listed only one other formal opponent to the proposal, Stanford University. Caltech, USC and the California Healthcare Institute have expressed "concerns." In support are Californians Aware, Calpirg and California Common Cause.
The tactic would avoid Sen. Deborah Ortiz' nasty problem of securing a two-thirds vote in both houses of the California legislature for her proposed constitutional amendment on the California stem cell agency.
That is a difficult task under the best of circumstances. Two-thirds approval means that members of both parties have to vote for a proposal. The requirement has been one of the main reasons for the yearly budget gridlock in Sacramento. While Ortiz' measure (SCA13) has bipartisan support, it is unclear whether that is sufficient to deliver all the votes she needs. Her task is even trickier given the timetable for placing a measure on the ballot. Normally the proposal would have to clear both houses by the end of June.
Now comes a little noticed comment in one legislative analysis of SCA13 from the Elections, Reapportionment and Constitutional Amendments Committee, which approved the measure earlier.
The analysis suggested that "the author and committee may wish to consider whether it would be more appropriate to, instead of asking the voters to place into the Constitution language aimed at providing more specificity to a statutory initiative, ask the voters to amend the initiative itself."
That would require a simple majority vote in both houses, the analysis said. But it would also require the governor's signature while a constitutional amendment does not.
There is no indication whether Ortiz is considering making such a change in her legislation.
Ortiz has scheduled a news conference call for noon Thursday (May 26). SCA13 comes up in the Senate Appropriations Committee later that afternoon. Ortiz also met with Robert Klein Wednesday to exchange views about the proposal, which the stem cell Oversight Committee unanimously opposed on Monday.
For the record, the committee analysis listed only one other formal opponent to the proposal, Stanford University. Caltech, USC and the California Healthcare Institute have expressed "concerns." In support are Californians Aware, Calpirg and California Common Cause.
Tuesday, May 24, 2005
Stem Cell Agency Lambastes Ortiz
If the senator from Sacramento is trying to get the attention of the California stem cell agency, she did in big way on Monday.
"How dare she!" said one Oversight Committee member, Jeff Sheehy. "How dare she steal hope from the people of California."
His remarks came during discussion of the proposed constitutional amendment by Sen. Deborah Ortiz, D-Sacramento, that would tighten conflict of interest standards for the agency and ensure that the agency and its working groups would be subject to state open meeting and open record laws.
The Oversight Committee unanimously voted to oppose the proposal, SCA13, which requires a 2/3 vote of both houses of the Legislature and voter approval before it would become law. The committee moved its June meeting to Sacramento so it could lobby lawmakers against the proposal.
Also likely to be flooding lawmakers with their opposition are large national patient groups, some of which are represented on the Oversight Committee.
Interestingly, perhaps significantly, the opposition statement by the stem cell agency did not mention Ortiz' companion measure, SB18. Whether the agency is in support of that measure, neutral or opposed is not clear at this point. Also not clear is whether the absence of mention of SB18 is part of a bargaining ploy.
Both SCA13 and SB18, which have bipartisan support, are in the Senate Appropriations Committee and are scheduled for a hearing on Thursday. If they are approved by the committee, they then move to the Senate floor.
Ortiz has a meeting scheduled with stem cell chairman Robert Klein on Wednesday and other Oversight Committee members during the week.
The agency issued a statement following Monday's meeting that said "as currently drafted" Ortiz' constitutional amendment will" make it extremely difficult, if not impossible, for scientists to do their jobs, and it will delay critically needed medical therapies."
Klein said, "We cannot understand this rush to judgment to try and get SCA13 on this fall’s ballot.”
"We need to send a shot over the bow of the Legislature," Caltech President David Baltimore, a member of the Oversight Committee, was quoted as saying by reporter Rone Tempest of the Los Angeles Times.
Ortiz told reporter Steve Johnson of the San Jose Mercury News, "Rather than joining me and trying to find a way to put sound accountability measures into the law, they have simply attempted to create the fear that accountability is equal to opposition.''
"There is no sinister plot here," Ortiz told Terri Somers of the San Diego Union Tribune, adding that the measure would not delay any possible therapies or treatments. "This legislation does not prevent them from moving forward and issuing grants."
One critical element of opposition to SCA13 is the board's apparent belief that few scientists would be willing to present their research proposals during partially open working group sessions of the agency despite the lure of the $3 billion research grant pool. Committee members noted that the usual grant procedures elsewhere call for private sessions. However, Ortiz' measure would allow for private sessions involving intellectual property, proprietary information and matters involving prepublication confidential scientific information.
Here are links to other stories on the subject this morning: Carl Hall, San Francisco Chronicle; Sandy Kleffman, Contra Costa Times.
"How dare she!" said one Oversight Committee member, Jeff Sheehy. "How dare she steal hope from the people of California."
His remarks came during discussion of the proposed constitutional amendment by Sen. Deborah Ortiz, D-Sacramento, that would tighten conflict of interest standards for the agency and ensure that the agency and its working groups would be subject to state open meeting and open record laws.
The Oversight Committee unanimously voted to oppose the proposal, SCA13, which requires a 2/3 vote of both houses of the Legislature and voter approval before it would become law. The committee moved its June meeting to Sacramento so it could lobby lawmakers against the proposal.
Also likely to be flooding lawmakers with their opposition are large national patient groups, some of which are represented on the Oversight Committee.
Interestingly, perhaps significantly, the opposition statement by the stem cell agency did not mention Ortiz' companion measure, SB18. Whether the agency is in support of that measure, neutral or opposed is not clear at this point. Also not clear is whether the absence of mention of SB18 is part of a bargaining ploy.
Both SCA13 and SB18, which have bipartisan support, are in the Senate Appropriations Committee and are scheduled for a hearing on Thursday. If they are approved by the committee, they then move to the Senate floor.
Ortiz has a meeting scheduled with stem cell chairman Robert Klein on Wednesday and other Oversight Committee members during the week.
The agency issued a statement following Monday's meeting that said "as currently drafted" Ortiz' constitutional amendment will" make it extremely difficult, if not impossible, for scientists to do their jobs, and it will delay critically needed medical therapies."
Klein said, "We cannot understand this rush to judgment to try and get SCA13 on this fall’s ballot.”
"We need to send a shot over the bow of the Legislature," Caltech President David Baltimore, a member of the Oversight Committee, was quoted as saying by reporter Rone Tempest of the Los Angeles Times.
Ortiz told reporter Steve Johnson of the San Jose Mercury News, "Rather than joining me and trying to find a way to put sound accountability measures into the law, they have simply attempted to create the fear that accountability is equal to opposition.''
"There is no sinister plot here," Ortiz told Terri Somers of the San Diego Union Tribune, adding that the measure would not delay any possible therapies or treatments. "This legislation does not prevent them from moving forward and issuing grants."
One critical element of opposition to SCA13 is the board's apparent belief that few scientists would be willing to present their research proposals during partially open working group sessions of the agency despite the lure of the $3 billion research grant pool. Committee members noted that the usual grant procedures elsewhere call for private sessions. However, Ortiz' measure would allow for private sessions involving intellectual property, proprietary information and matters involving prepublication confidential scientific information.
Here are links to other stories on the subject this morning: Carl Hall, San Francisco Chronicle; Sandy Kleffman, Contra Costa Times.
Correction
We had a bad link on the "Political Interference, Venture Capitalists" item May 23. Here is the correct link to the article in question.
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