Friday, April 01, 2005
Correction
On March 30, we incorrectly reported that the oversight committee will meet next Wednesday. The date of the meeting is actually Thursday April 7.
Wednesday, March 30, 2005
Here Comes $3 Billion
The California stem cell agency appears ready to take the first steps towards issuing $3 billion in bonds to finance its efforts to find cures and treatment for everything from cancer to Lou Gehrig's disease.
The oversight committee of the agency meets one week from today in Los Angeles, only the fifth meeting since it came into existence. On the agenda is a resolution that would set the bond process in motion.
Also on the agenda is Christian right litigation that has raised uncertainty about the bonds and seeks to terminate the agency itself, despite that the fact that it was created by voters approving an amendment to the California state constitution.
Chairman Robert Klein has promised to come up with a strategy to squelch the bond uncertainty at the April meeting. Just what that is will have to wait until after a closed- door litigation session at the meeting.
Also on the agenda is an item that could speed some of the processes at CIRM. It calls for charging the institute staff with developing a proposal for the agency's research grants program. The staff proposal would then be considered by the full oversight committee at the May 6 meeting of the oversight committee.
The schedule for next Wednesday additionally calls for “consideration” of a host of issues including: conflict policies for oversight committee members and agency staff, policies for working groups including confidentiality and conflicts issues and a training grant program for future stem cell researchers.
The oversight committee of the agency meets one week from today in Los Angeles, only the fifth meeting since it came into existence. On the agenda is a resolution that would set the bond process in motion.
Also on the agenda is Christian right litigation that has raised uncertainty about the bonds and seeks to terminate the agency itself, despite that the fact that it was created by voters approving an amendment to the California state constitution.
Chairman Robert Klein has promised to come up with a strategy to squelch the bond uncertainty at the April meeting. Just what that is will have to wait until after a closed- door litigation session at the meeting.
Also on the agenda is an item that could speed some of the processes at CIRM. It calls for charging the institute staff with developing a proposal for the agency's research grants program. The staff proposal would then be considered by the full oversight committee at the May 6 meeting of the oversight committee.
The schedule for next Wednesday additionally calls for “consideration” of a host of issues including: conflict policies for oversight committee members and agency staff, policies for working groups including confidentiality and conflicts issues and a training grant program for future stem cell researchers.
Tuesday, March 29, 2005
Super Ovulation and Ortiz
If you haven't seen it already, reporter Laura Mecoy's story on the super ovulation issue and California State Sen. Deborah Ortiz is worth a read.
Mecoy, who writes for The Sacramento Bee, explores the reasons for Ortiz' position, which has greatly disappointed some who used to consider her a staunch ally. Ortiz, on the other hand, says she is not abandoning them.
She told Mecoy, "I just want to have a full discussion because we are changing from what we said during the campaign (for Prop. 71), and that troubles me."
The measure itself recognizes some of the problems with the issue, barring purchase of eggs from donors but apparently allowing for compensation for expenses.
Substantial money is to be made from stem cells as they are turned into medical products. That invariably will entice some to skirt, at the minimum, the edges of ethical behavior, which are not all that clear on stem cell matters anyway. Ortiz' concern seems merited.
But Mecoy also notes that at the same people are in misery. She quoted a mother of two in Davis who suffered a spinal cord injury 12 years ago.
“Three more years ... could be a matter of whether I make it out of this
chair or not," said Karen Miner. "I don't understand this push to delay this for three more years when we have all fought so hard, and people are dying."
Mecoy, who writes for The Sacramento Bee, explores the reasons for Ortiz' position, which has greatly disappointed some who used to consider her a staunch ally. Ortiz, on the other hand, says she is not abandoning them.
She told Mecoy, "I just want to have a full discussion because we are changing from what we said during the campaign (for Prop. 71), and that troubles me."
The measure itself recognizes some of the problems with the issue, barring purchase of eggs from donors but apparently allowing for compensation for expenses.
Substantial money is to be made from stem cells as they are turned into medical products. That invariably will entice some to skirt, at the minimum, the edges of ethical behavior, which are not all that clear on stem cell matters anyway. Ortiz' concern seems merited.
But Mecoy also notes that at the same people are in misery. She quoted a mother of two in Davis who suffered a spinal cord injury 12 years ago.
“Three more years ... could be a matter of whether I make it out of this
chair or not," said Karen Miner. "I don't understand this push to delay this for three more years when we have all fought so hard, and people are dying."
Monday, March 28, 2005
Citizen-bioethicists and Stem Cells
California's stem cell agency is coming under scrutiny in the hallowed halls of UC Berkeley.
In what may be the only course of its kind in the country, students are examining the conduct of the agency and stem cell issues in general.
Topics for this week's classes are “Going Corporate: Patenting and Secrecy” and “Markets for What?” The class readings on the subjects include the websites of both Geron and CIRM. Also required this week is a book titled “Body Bazaar: The Market for Human Tissue in the Biotechnology Age.”
The class is called "Rhetoric of Scientific Discourse: Stem Cells, Cloning, and the Genetic Imaginary." Rhetoric and women's studies professor Charis Thompson devised it to analyze ethical and political implications of cutting-edge scientific proposals and activity. She taught a similar class at Harvard University before joining the UC Berkeley faculty in fall 2003, according to a report by Noel Gallagher, a writer for the Berkeley campus.
"We are increasingly being asked to act as what I call 'citizen-bioethicists,' and to have political and personal opinions about scientific, technical and medical matters," Thompson told Gallagher. "This class is an attempt to outfit us for that role."
The first assignment for the 30 undergraduate students in the course was to read the full text of Prop. 71, making them part of the handful of persons who have actually done so.
The class began in January and will end in May. In the meantime, students will dig in such areas as “links between democracy and science” and “governance and genetics.”
Thompson told us that she has a grant that will enable 8 undergraduates and 2 graduate students to continue research in the area. She also said, “I am working with the oral history group on campus to begin a stem cell archive. In theory the class, or a variant of it, as issues develop, will always be offered in the spring.”
In what may be the only course of its kind in the country, students are examining the conduct of the agency and stem cell issues in general.
Topics for this week's classes are “Going Corporate: Patenting and Secrecy” and “Markets for What?” The class readings on the subjects include the websites of both Geron and CIRM. Also required this week is a book titled “Body Bazaar: The Market for Human Tissue in the Biotechnology Age.”
The class is called "Rhetoric of Scientific Discourse: Stem Cells, Cloning, and the Genetic Imaginary." Rhetoric and women's studies professor Charis Thompson devised it to analyze ethical and political implications of cutting-edge scientific proposals and activity. She taught a similar class at Harvard University before joining the UC Berkeley faculty in fall 2003, according to a report by Noel Gallagher, a writer for the Berkeley campus.
"We are increasingly being asked to act as what I call 'citizen-bioethicists,' and to have political and personal opinions about scientific, technical and medical matters," Thompson told Gallagher. "This class is an attempt to outfit us for that role."
The first assignment for the 30 undergraduate students in the course was to read the full text of Prop. 71, making them part of the handful of persons who have actually done so.
The class began in January and will end in May. In the meantime, students will dig in such areas as “links between democracy and science” and “governance and genetics.”
Thompson told us that she has a grant that will enable 8 undergraduates and 2 graduate students to continue research in the area. She also said, “I am working with the oral history group on campus to begin a stem cell archive. In theory the class, or a variant of it, as issues develop, will always be offered in the spring.”
Friday, March 25, 2005
Business, Politics, Stem Cells and Steve Westly
Chris Nolan, in a column for eWEEK, touches again on the interplay of business and government in relation to the California stem cell agency.
Her points are good and often not well understood by students of business or politics. Having worked in both politics and government and in the private sector, including entrepreneurial roles, I can vouch that some of the skills are the same but some are different. The different frames of reference that are required may be what give crossover efforts difficulty. But it can be done. Felix Rohatyn, who was instrumental in rescuing New York City from bankruptcy many years ago, is one person who comes to mind as a skillful practitioner of politics and business.
The eWeek column begins: “Robert Klein, the Palo Alto, Calif., real estate developer who pushed the measure to passage, has been making some serious missteps, sending the wrong signals about how he'll deal with state officials.
“His organization, the California Institute for Regenerative Medicine, and the 29-member panel that oversees its work, the Independent Citizens Oversight Committee, have run into trouble over what—to a businessperson—sound like technical details.”
Nolan also writes about the agency on her “Politics Left and Right” blog, which suggests, among other things, that State Controller Steve Westly provide some additional assistance to CIRM.
She says he is “a creature of Silicon Valley (who) understands how guys like Klein think (and) was an early and eager back of the stem cell proposition because he correctly saw it as a jobs measure. He's also been friendly with Gov. Schwarzenegger who, it seems, taught Westly a few things about political grace while the pair went campaigning together last year. Westly's got financial oversight responsibility for Klein's committee; he's perfectly positioned to take some irons out of the fire here. And he ought to do it. This could very quickly become a intra-mural Democratic party fight. Or worse.”
Her points are good and often not well understood by students of business or politics. Having worked in both politics and government and in the private sector, including entrepreneurial roles, I can vouch that some of the skills are the same but some are different. The different frames of reference that are required may be what give crossover efforts difficulty. But it can be done. Felix Rohatyn, who was instrumental in rescuing New York City from bankruptcy many years ago, is one person who comes to mind as a skillful practitioner of politics and business.
The eWeek column begins: “Robert Klein, the Palo Alto, Calif., real estate developer who pushed the measure to passage, has been making some serious missteps, sending the wrong signals about how he'll deal with state officials.
“His organization, the California Institute for Regenerative Medicine, and the 29-member panel that oversees its work, the Independent Citizens Oversight Committee, have run into trouble over what—to a businessperson—sound like technical details.”
Nolan also writes about the agency on her “Politics Left and Right” blog, which suggests, among other things, that State Controller Steve Westly provide some additional assistance to CIRM.
She says he is “a creature of Silicon Valley (who) understands how guys like Klein think (and) was an early and eager back of the stem cell proposition because he correctly saw it as a jobs measure. He's also been friendly with Gov. Schwarzenegger who, it seems, taught Westly a few things about political grace while the pair went campaigning together last year. Westly's got financial oversight responsibility for Klein's committee; he's perfectly positioned to take some irons out of the fire here. And he ought to do it. This could very quickly become a intra-mural Democratic party fight. Or worse.”
Next Step in Lawsuits
Uncertainty is the bane of bonds. Look for the California stem cell agency to move after its April meeting to attempt to ease the impact of the refusal by the state Supreme Court to rule on the legality of the agency.
Robert Klein, chairman of the agency, told the San Francisco Chronicle he would offer an “alternative” plan at the board's meeting early next month.
Reporter Bob Egelko wrote, " 'As long as there's a challenge pending, there's a cloud over issuance of the bonds,' said Deputy Attorney General Tamar Pachter, the state's lawyer.”
One tactic would be for the agency to file its own suit to force a decision on the issues.
Here are links to stories by Paul Elias of The Associated Press and Laura Mecoy of The Sacramento Bee on the case.
”
Robert Klein, chairman of the agency, told the San Francisco Chronicle he would offer an “alternative” plan at the board's meeting early next month.
Reporter Bob Egelko wrote, " 'As long as there's a challenge pending, there's a cloud over issuance of the bonds,' said Deputy Attorney General Tamar Pachter, the state's lawyer.”
One tactic would be for the agency to file its own suit to force a decision on the issues.
Here are links to stories by Paul Elias of The Associated Press and Laura Mecoy of The Sacramento Bee on the case.
”
Wednesday, March 23, 2005
The Fallacy of the Will of the People
More than two-thirds of the people of California don't care about their state's new stem cell agency or oppose it.
Bad news for this blog and bad news for those who argue that Prop. 71 represents the will of the people.
For those of you who recall that Prop. 71 was approved by 59 percent of voters, the apparent lack of support may come as a surprise. But just as in business, there are numbers and then there are other numbers. Ask Bernie Ebbers, former CEO of WorldCom.
Robert Klein, chairman of the stem cell agency, and others cite the 59 percent figure as a justification for keeping bothersome legislators out of their business. Prop. 71 is the will of the people, they say. What they fail to understand are the real numbers and their significance. Say “aw shucks” to Mr. Ebbers.
Given the recent controversies involving the agency, what its supporters should be concerned about are the 15 million Californians – 68 percent of the voting population -- who either opposed or did not feel strongly about Prop. 71 in last fall's election. That group represents an opening, a potential market for those would seek to destroy CIRM.
Before we venture on, let's look at the numbers from last fall. California's secretary of state reports that in the November election, the state counted 22 million eligible voters, meaning “the people.” Only seven million supported Prop. 71 – 32 percent of eligible voters. Another 4.9 million – 21 percent of eligible voters – opposed it.
How can this be, you might ask, given the 59 percent approval figure? It is fairly simple. That number is derived only from the people who voted, and many did not.
Out of the 22 million possible voters, only 16.6 million chose to register to vote. Minus those who actually voted for or against Prop. 71, that leaves 4.7 million registered voters who skipped right by Prop. 71 and another 5.6 million people who just did not care at all (did not register to vote). Add up the opposition voters (4.9 million), registered voters who chose not to vote on the measure (4.7 million) and those who did not register vote (5.6 million) and you have roughly 15 million people, give or take a few because of rounding.
President Bush and his minions last year taught us all a lesson about numbers like these. They looked at the persons who ordinarily did not vote. They mobilized them (mainly using the Christian right), energized them and thrashed John Kerry.
There is nothing new about people not registering or not choosing to vote once they are registered. But it means that Klein and company cannot find much solace in the 59 percent figure. It could easily turn into so much dross. Last fall's election was dominated by presidential politics. Most observers agree that voters did not look closely at Prop. 71, along with a bunch of other state measures. A substantial segment of the population, properly motivated, could turn on CIRM, a situation that a fledgling bureaucracy does not need.
If these numbers come as a surprise, it is because the media and others, for years, have become comfortable with using a flaccid shorthand. The persons who cast ballots become “the people.” Forgotten are the rest who rise up from time to time and do strange things.
On March 16, Klein said that “the voters of California sent a clear message.” Perhaps or perhaps not. But there is certainly an opening for the enemies of CIRM, especially since an oversight measure could be placed on the ballot next fall. The chairman might best heed the counsel of Zach Hall, the new president of the agency, who said on March 9, “The success of our venture will critically depend on the confidence of the people of California in our integrity and credibility. Decisions made by the Institute must be transparent and must be perceived to be fair and objective judgments based on scientific merit, free of bias and conflict of interest.”
Needless to say, “perceived” is a very important word for the agency.
Bad news for this blog and bad news for those who argue that Prop. 71 represents the will of the people.
For those of you who recall that Prop. 71 was approved by 59 percent of voters, the apparent lack of support may come as a surprise. But just as in business, there are numbers and then there are other numbers. Ask Bernie Ebbers, former CEO of WorldCom.
Robert Klein, chairman of the stem cell agency, and others cite the 59 percent figure as a justification for keeping bothersome legislators out of their business. Prop. 71 is the will of the people, they say. What they fail to understand are the real numbers and their significance. Say “aw shucks” to Mr. Ebbers.
Given the recent controversies involving the agency, what its supporters should be concerned about are the 15 million Californians – 68 percent of the voting population -- who either opposed or did not feel strongly about Prop. 71 in last fall's election. That group represents an opening, a potential market for those would seek to destroy CIRM.
Before we venture on, let's look at the numbers from last fall. California's secretary of state reports that in the November election, the state counted 22 million eligible voters, meaning “the people.” Only seven million supported Prop. 71 – 32 percent of eligible voters. Another 4.9 million – 21 percent of eligible voters – opposed it.
How can this be, you might ask, given the 59 percent approval figure? It is fairly simple. That number is derived only from the people who voted, and many did not.
Out of the 22 million possible voters, only 16.6 million chose to register to vote. Minus those who actually voted for or against Prop. 71, that leaves 4.7 million registered voters who skipped right by Prop. 71 and another 5.6 million people who just did not care at all (did not register to vote). Add up the opposition voters (4.9 million), registered voters who chose not to vote on the measure (4.7 million) and those who did not register vote (5.6 million) and you have roughly 15 million people, give or take a few because of rounding.
President Bush and his minions last year taught us all a lesson about numbers like these. They looked at the persons who ordinarily did not vote. They mobilized them (mainly using the Christian right), energized them and thrashed John Kerry.
There is nothing new about people not registering or not choosing to vote once they are registered. But it means that Klein and company cannot find much solace in the 59 percent figure. It could easily turn into so much dross. Last fall's election was dominated by presidential politics. Most observers agree that voters did not look closely at Prop. 71, along with a bunch of other state measures. A substantial segment of the population, properly motivated, could turn on CIRM, a situation that a fledgling bureaucracy does not need.
If these numbers come as a surprise, it is because the media and others, for years, have become comfortable with using a flaccid shorthand. The persons who cast ballots become “the people.” Forgotten are the rest who rise up from time to time and do strange things.
On March 16, Klein said that “the voters of California sent a clear message.” Perhaps or perhaps not. But there is certainly an opening for the enemies of CIRM, especially since an oversight measure could be placed on the ballot next fall. The chairman might best heed the counsel of Zach Hall, the new president of the agency, who said on March 9, “The success of our venture will critically depend on the confidence of the people of California in our integrity and credibility. Decisions made by the Institute must be transparent and must be perceived to be fair and objective judgments based on scientific merit, free of bias and conflict of interest.”
Needless to say, “perceived” is a very important word for the agency.
Tuesday, March 22, 2005
Lee-Halpern Petition Rejected by Klein
Reporter Laura Mecoy of The Sacramento Bee looks like she is alone on rejection of every point of the Lee-Halpern petition by Robert Klein, chairman of the California stem cell agency.
Writing this morning, she said:
"The chairman of the state stem cell agency's oversight board rejected every point in a petition seeking more open meetings, stricter conflict-of-interest rules and salary caps at California's new research institute.
"But with pressure mounting in the Legislature and the courts to address these issues, the chairman said Monday the panel would hold hearings seeking a wide range of views on each issue - rather than limiting itself to the petitioners' views.
"These are important issues which we have set up public hearings to address," Chairman Robert Klein II said. "But to make a deal with a special interest group is not consistent with the interests of the public in having a full public hearing of these issues."
Writing this morning, she said:
"The chairman of the state stem cell agency's oversight board rejected every point in a petition seeking more open meetings, stricter conflict-of-interest rules and salary caps at California's new research institute.
"But with pressure mounting in the Legislature and the courts to address these issues, the chairman said Monday the panel would hold hearings seeking a wide range of views on each issue - rather than limiting itself to the petitioners' views.
"These are important issues which we have set up public hearings to address," Chairman Robert Klein II said. "But to make a deal with a special interest group is not consistent with the interests of the public in having a full public hearing of these issues."
Blogosphere Simmers with Stem Cell Commentary
“Sweetheart deal,” “irrational pandering” by cities, subversion of the people's will – all these and more are part of the freshly flowering cyberspace commentary on California's stem cell agency.
In recent days,we have seen a spate of postings. They include a blog on the website of the influential Washington Monthly magazine and on the website of the American Journal of Bioethics.
Kevin Drum, who writes the Political Animal blog for Washington Monthly, called Prop. 71 “something of a sweetheart deal written by the biotech industry and rather clearly for the benefit of the biotech industry.”
His item triggered a string of comments, including one from a writer called Platypus, who described him(her)self as a “molecular geneticist who has reviewed grants for one of California's other targeted research programs (the California Breast Cancer Research Program).”
“There is almost certainly a large mismatch between the amount of money that is suddenly available ($300 million/yr) and the number of California-based researchers who currently are carrying out high quality stem cell research,” Platypus said. “So, a major challenge/serious problem is how to spend the money wisely. Right now you could fund all the really great stem cell research projects in California on a fraction of the available money.”
“So, what do you do with the rest of the $300 million/yr? Some of it could (and should) be used to build up research infrastructure and lure additional stem cell researchers to California, However, any benefit from this expansion in research capacity will take years. In order to show that Californians are getting immediate results for their tax dollars, there will be great political pressure to fund as many projects as possible as soon as possible, resulting in wasting a good deal of the public's money on mediocre (or worse) science.
“I hope the program succeeds, but it's going to be difficult to carry out successfully. The initial structuring of the program is key, so that it not turn into the California Biotech Industry Relief Act of 2004.
“Finally, you can't just buy a scientific breakthrough, no matter how much money you throw at the problem. There is great danger in misleading the public as to what we can and can't do as medical researchers.”
David Magnus, writing on blog.bioethics.net on the website of the American Journal of Bioethics, noted that Prop. 71 insulated funding and management from state lawmakers. He said the tough issues that must be faced are better handled by the stem cell agency's oversight committee rather than becoming "fodder for political gamesmanship in the legislature.”
“Unsurprisingly, the state legislature is unhappy with the fact that they are not relevant to an important undertaking within the state. State Sen. Deborah Ortiz (possibly motivated by a desire for higher public office) has abandoned her long standing support of stem cell research and is attempting to subvert the expressed will of the people,” said Magnus, who is director of the Stanford Center for Biomedical Ethics.
He cited Ortiz' measure to make it “illegal for women to voluntarily serve as oocyte donors for the expressed purposes of research (since in practice these women take drugs to superovulate to produce a sufficient number of eggs).”
“It is worth noting,” Magnus said, “that women routinely do this in IVF, and in fact, there is nothing to prohibit women from continuing to produce eggs as surrogates for other people trying to reproduce. Apparently Ortiz believes that assisting reproductively challenged individuals is sufficiently important that women should be allowed to make this decision, but research is not important enough to allow anyone to expose themselves to risk.
“This issue highlights the difficulty of turning these matters over to a legislature that fundamentally lacks knowledge or insight into the research process or into the details of the practice of medicine. The citizens of California wisely chose to pass a measure that had built in measures for oversight and public accountability—the fact that the legislature is left out is a poor reason to undo the will of the people.”
On the Local Liberty blog of the Center for Local Government at the Claremont Institute, Matthew Peterson deplored the “irrational pandering of California cities in their mad quest to land the offices of the CIRM. One of the best summaries is, no suprise, posted on a blog(editor's note: Peterson was referring the “lusting” item on this blog).”
He added, “It's all too easy to simply throw money down for a quick fix—such fast food solutions inevitably lead to failure.
“In this case, even the friendliest supporter of all things CIRM has to stop and wonder. Sure there are ways in which the offices will bring financial benefits with them, but isn't a big part of the radical pursuit of the 50 person office really stemming from a desire to have a "cool," "cutting-edge," "progressive" image?”
Peterson is writing a piece for the Claremont Institute which will explain why he believes the stem cell agency “combines the worst tendencies of modern politics: the promise of a New Man, democratic forms masking government in the shadows and taxpayer-subsidized bureaucracy.”
In recent days,we have seen a spate of postings. They include a blog on the website of the influential Washington Monthly magazine and on the website of the American Journal of Bioethics.
Kevin Drum, who writes the Political Animal blog for Washington Monthly, called Prop. 71 “something of a sweetheart deal written by the biotech industry and rather clearly for the benefit of the biotech industry.”
His item triggered a string of comments, including one from a writer called Platypus, who described him(her)self as a “molecular geneticist who has reviewed grants for one of California's other targeted research programs (the California Breast Cancer Research Program).”
“There is almost certainly a large mismatch between the amount of money that is suddenly available ($300 million/yr) and the number of California-based researchers who currently are carrying out high quality stem cell research,” Platypus said. “So, a major challenge/serious problem is how to spend the money wisely. Right now you could fund all the really great stem cell research projects in California on a fraction of the available money.”
“So, what do you do with the rest of the $300 million/yr? Some of it could (and should) be used to build up research infrastructure and lure additional stem cell researchers to California, However, any benefit from this expansion in research capacity will take years. In order to show that Californians are getting immediate results for their tax dollars, there will be great political pressure to fund as many projects as possible as soon as possible, resulting in wasting a good deal of the public's money on mediocre (or worse) science.
“I hope the program succeeds, but it's going to be difficult to carry out successfully. The initial structuring of the program is key, so that it not turn into the California Biotech Industry Relief Act of 2004.
“Finally, you can't just buy a scientific breakthrough, no matter how much money you throw at the problem. There is great danger in misleading the public as to what we can and can't do as medical researchers.”
David Magnus, writing on blog.bioethics.net on the website of the American Journal of Bioethics, noted that Prop. 71 insulated funding and management from state lawmakers. He said the tough issues that must be faced are better handled by the stem cell agency's oversight committee rather than becoming "fodder for political gamesmanship in the legislature.”
“Unsurprisingly, the state legislature is unhappy with the fact that they are not relevant to an important undertaking within the state. State Sen. Deborah Ortiz (possibly motivated by a desire for higher public office) has abandoned her long standing support of stem cell research and is attempting to subvert the expressed will of the people,” said Magnus, who is director of the Stanford Center for Biomedical Ethics.
He cited Ortiz' measure to make it “illegal for women to voluntarily serve as oocyte donors for the expressed purposes of research (since in practice these women take drugs to superovulate to produce a sufficient number of eggs).”
“It is worth noting,” Magnus said, “that women routinely do this in IVF, and in fact, there is nothing to prohibit women from continuing to produce eggs as surrogates for other people trying to reproduce. Apparently Ortiz believes that assisting reproductively challenged individuals is sufficiently important that women should be allowed to make this decision, but research is not important enough to allow anyone to expose themselves to risk.
“This issue highlights the difficulty of turning these matters over to a legislature that fundamentally lacks knowledge or insight into the research process or into the details of the practice of medicine. The citizens of California wisely chose to pass a measure that had built in measures for oversight and public accountability—the fact that the legislature is left out is a poor reason to undo the will of the people.”
On the Local Liberty blog of the Center for Local Government at the Claremont Institute, Matthew Peterson deplored the “irrational pandering of California cities in their mad quest to land the offices of the CIRM. One of the best summaries is, no suprise, posted on a blog(editor's note: Peterson was referring the “lusting” item on this blog).”
He added, “It's all too easy to simply throw money down for a quick fix—such fast food solutions inevitably lead to failure.
“In this case, even the friendliest supporter of all things CIRM has to stop and wonder. Sure there are ways in which the offices will bring financial benefits with them, but isn't a big part of the radical pursuit of the 50 person office really stemming from a desire to have a "cool," "cutting-edge," "progressive" image?”
Peterson is writing a piece for the Claremont Institute which will explain why he believes the stem cell agency “combines the worst tendencies of modern politics: the promise of a New Man, democratic forms masking government in the shadows and taxpayer-subsidized bureaucracy.”
Monday, March 21, 2005
Two Critical Views of the Stem Cell Agency
The Sacramento Bee has editorialized on the current situation with the stem cell agency, suggesting that it move at its April meeting to alleviate legislative concerns.
The editorial said, "Given that (Chairman Robert) Klein seems disinclined to publicly lead the stem cell program, members of the Independent Citizens Oversight Committee should take this role upon themselves. Prior to the next meeting, this oversight committee needs to set its own agenda, and put the institute on a course that marries science with accountability."
Long time journalist and blogger Chris Nolan has provided insight into the thinking that may be part of the problems at the agency.
She wrote in Politics from Left to Right, "Some of what's going on here is a failure to understand the difference between private and public funding, a classic mistake made by business folks trying to work the political system and a profound weakness for that sometimes arrogant crowd known as Progressive libertarians. They want government to run like a business: Efficiently and with smart folks like them in charge. But there reasons -- lots of good ones -- that we have oversight and open meetings laws."
The editorial said, "Given that (Chairman Robert) Klein seems disinclined to publicly lead the stem cell program, members of the Independent Citizens Oversight Committee should take this role upon themselves. Prior to the next meeting, this oversight committee needs to set its own agenda, and put the institute on a course that marries science with accountability."
Long time journalist and blogger Chris Nolan has provided insight into the thinking that may be part of the problems at the agency.
She wrote in Politics from Left to Right, "Some of what's going on here is a failure to understand the difference between private and public funding, a classic mistake made by business folks trying to work the political system and a profound weakness for that sometimes arrogant crowd known as Progressive libertarians. They want government to run like a business: Efficiently and with smart folks like them in charge. But there reasons -- lots of good ones -- that we have oversight and open meetings laws."
Correction
On Friday, we incorrectly stated that Robert Klein worked and lived in San Mateo County. In fact, he works and lives in Santa Clara County, just south of San Mateo.
Friday, March 18, 2005
Lusting for the Stem Cell HQ
Can you say stem cell concierge? Can you say private jet service? If you can, you are talking about the bids cities have made for the headquarters of the California stem cell agency.
Lust is a good word for it. Longing for the permanent headquarters of the California Institute for Regenerative Medicine has prompted localities throughout the state to cough up commitments for crisis counseling to cops.
We have put together the following compilation of bids from a variety of newspaper reports over the past several days. It is only semi-complete, as is everything on this blog. Totally missing is San Mateo County, which was not available when we gathered the information. That is important because that county is where Robert Klein, chairman of CIRM, lives and does business. We will give you San Mateo when it weighs in.
Basically all the areas are offering free rent for 10 years. Some offers exceed the requested square footage by 3,000 feet. Links to a bunch of HQ news stories are at the end of this piece.
Keep in mind that this listing is based on what has been reported. Do not assume, for example, that Sacramento has not offered free health club memberships while others have. Probably it has not been reported in the press. Moreover, the negotiation process in the bidding will see many added incentives.
We are going to go with The Big Tomato (Sacramento) first in a blatant display of partisanship. This writer lived in the The Big Tomato for 21 years, most of which were a great pleasure. That said, we have been absent from the Golden State for more than six years. We have no financial interest anywhere in California, either in real property, biotechnology of any sort, venture capital, stocks or anything else, unless they are held in a mutual fund. But we do figure that listing Sacramento first in this rundown will give it the heft to put it over the top. Everybody else will have to be satisfied with alphabetical order.
Sacramento -- The city of Sacramento and the Angelo Tsakopoulos family made an offer the city valued at $7.3 million. It includes rent-free offices at One Capitol Mall in Old Sacramento, free parking and conference space, and up to $800,000 in cash for tenant improvements. The Angelo Tsakopoulos family also offered $450,000 in free utilities and services. Wendy Saunders, Sacramento's economic development director, said the city's contributions of conference space and parking were worth $750,000. Views of the Sacramento River are promised as well as a short jaunt to the Capitol itself.
Emeryville -- City leaders want to keep the headquarters right where it is now, in temporary facilities at the Emery Station office park on Horton Street, across the street from an Amtrak station. City officials said that slightly more than half of all U.S. biotech companies have their headquarters in the Bay Area -- a third of them in Emeryville, such as Chiron and Bayer corporations. The offer includes free health club, free use of Pixar Animation Studios' digital theater and gourmet kitchen; reduced rate hotel rooms for visiting scientists; free use of conference rooms at Chiron Corp.; free parking; free shuttles from BART. The current landlords have touted their connections to Chiron, one of whose founders is Ed Penhoet, who is vice chairman of the stem cell agency oversight committee.
Los Angeles – Space at City National Plaza downtown, along with $1 million in grants “to support administrative efforts,” private jet services, free round-the-clock concierge service, a police liaison and 10 free days of large meeting space.
San Diego – A $9 million offer, according to the city. But then it adds that it is “worth a million dollars (more) to be out there on Torrey Mesa overlooking Torrey Pines Golf Course and the Pacific Ocean, and to be surrounded by UCSD and some of the finest research institutions in America." San Diego offers a "readiness team" to assist in planning, coordination and startup of the facility, furnishings and systems and an "advisory council,"a group of top local executives available for advice, introductions within the community, resources and crisis support. Included are 100 hours of free legal services, free branding and marketing advice from public-relations firm Mentus.
San Francisco – The $10 million package includes 20,000 square feet of free office space in a year-old building at 250 King St., known as Mission Place, across the street from the Giants ballpark and a short walk to UC San Francisco's new biosciences campus in Mission Bay. It also includes free shuttles, discounted gym memberships and the use of City Hall, SBC Park and city-owned convention facilities for gatherings, free high-cost videoconferencing equipment and broadband access, free and discounted office furnishings, free and reduced-rate hotel rooms and limo service and no-cost Web communications.
San Jose – The San Jose mayor, whose name shall be omitted in this sentence because he is shameless, personally pony-expressed 10 copies of his city's 25-page proposal to Sacramento, all in the hopes of generating more press coverage. San Jose offered two locations: The Concourse in North San Jose Innovation Triangle, 1731 Technology Drive; or Fairmont Plaza downtown at 50 W. San Fernando St. Perks: $500,000 in free tenant improvements, free parking, on-site exercise facilities, cut-rate hotel rooms, free furniture, security liaison at San Jose Police Department, donated video and computer setups,free round-the-clock concierge service and 10 free days of large meeting space.
Lust is a good word for it. Longing for the permanent headquarters of the California Institute for Regenerative Medicine has prompted localities throughout the state to cough up commitments for crisis counseling to cops.
We have put together the following compilation of bids from a variety of newspaper reports over the past several days. It is only semi-complete, as is everything on this blog. Totally missing is San Mateo County, which was not available when we gathered the information. That is important because that county is where Robert Klein, chairman of CIRM, lives and does business. We will give you San Mateo when it weighs in.
Basically all the areas are offering free rent for 10 years. Some offers exceed the requested square footage by 3,000 feet. Links to a bunch of HQ news stories are at the end of this piece.
Keep in mind that this listing is based on what has been reported. Do not assume, for example, that Sacramento has not offered free health club memberships while others have. Probably it has not been reported in the press. Moreover, the negotiation process in the bidding will see many added incentives.
We are going to go with The Big Tomato (Sacramento) first in a blatant display of partisanship. This writer lived in the The Big Tomato for 21 years, most of which were a great pleasure. That said, we have been absent from the Golden State for more than six years. We have no financial interest anywhere in California, either in real property, biotechnology of any sort, venture capital, stocks or anything else, unless they are held in a mutual fund. But we do figure that listing Sacramento first in this rundown will give it the heft to put it over the top. Everybody else will have to be satisfied with alphabetical order.
Sacramento -- The city of Sacramento and the Angelo Tsakopoulos family made an offer the city valued at $7.3 million. It includes rent-free offices at One Capitol Mall in Old Sacramento, free parking and conference space, and up to $800,000 in cash for tenant improvements. The Angelo Tsakopoulos family also offered $450,000 in free utilities and services. Wendy Saunders, Sacramento's economic development director, said the city's contributions of conference space and parking were worth $750,000. Views of the Sacramento River are promised as well as a short jaunt to the Capitol itself.
Emeryville -- City leaders want to keep the headquarters right where it is now, in temporary facilities at the Emery Station office park on Horton Street, across the street from an Amtrak station. City officials said that slightly more than half of all U.S. biotech companies have their headquarters in the Bay Area -- a third of them in Emeryville, such as Chiron and Bayer corporations. The offer includes free health club, free use of Pixar Animation Studios' digital theater and gourmet kitchen; reduced rate hotel rooms for visiting scientists; free use of conference rooms at Chiron Corp.; free parking; free shuttles from BART. The current landlords have touted their connections to Chiron, one of whose founders is Ed Penhoet, who is vice chairman of the stem cell agency oversight committee.
Los Angeles – Space at City National Plaza downtown, along with $1 million in grants “to support administrative efforts,” private jet services, free round-the-clock concierge service, a police liaison and 10 free days of large meeting space.
San Diego – A $9 million offer, according to the city. But then it adds that it is “worth a million dollars (more) to be out there on Torrey Mesa overlooking Torrey Pines Golf Course and the Pacific Ocean, and to be surrounded by UCSD and some of the finest research institutions in America." San Diego offers a "readiness team" to assist in planning, coordination and startup of the facility, furnishings and systems and an "advisory council,"a group of top local executives available for advice, introductions within the community, resources and crisis support. Included are 100 hours of free legal services, free branding and marketing advice from public-relations firm Mentus.
San Francisco – The $10 million package includes 20,000 square feet of free office space in a year-old building at 250 King St., known as Mission Place, across the street from the Giants ballpark and a short walk to UC San Francisco's new biosciences campus in Mission Bay. It also includes free shuttles, discounted gym memberships and the use of City Hall, SBC Park and city-owned convention facilities for gatherings, free high-cost videoconferencing equipment and broadband access, free and discounted office furnishings, free and reduced-rate hotel rooms and limo service and no-cost Web communications.
San Jose – The San Jose mayor, whose name shall be omitted in this sentence because he is shameless, personally pony-expressed 10 copies of his city's 25-page proposal to Sacramento, all in the hopes of generating more press coverage. San Jose offered two locations: The Concourse in North San Jose Innovation Triangle, 1731 Technology Drive; or Fairmont Plaza downtown at 50 W. San Fernando St. Perks: $500,000 in free tenant improvements, free parking, on-site exercise facilities, cut-rate hotel rooms, free furniture, security liaison at San Jose Police Department, donated video and computer setups,free round-the-clock concierge service and 10 free days of large meeting space.
Here are links to many of the stem cell HQ stories: San Francisco Chronicle, San Diego Union Tribune, Sacramento Bee, Los Angeles Times, LA Business Journal, Silicon Valley Business Journal.
Thursday, March 17, 2005
A Litany of Losses
The score looks dismal in week 13 in the life of the California Institute for Regenerative Medicine.
But the truly sad part about it is that much of the pain was unnecessary and is now hobbling an agency that was born with great expectations.
Here is a partial scorecard:
1. The agency now faces a potential ballot fight, possibly as early as next fall, if a proposed constitutional amendment to tighten oversight passes in time.
2. The bond market, where the agency hopes to raise billions, is judged to be skittish about any offerings given the current state of litigation against the agency.
3. Powerful supporters in the California legislature are now wary and suspicious, aligning themselves with those who would be ecstatic if the agency vanished from the earth.
4. Critical and nagging questions have been aired in the media across the country concerning the conduct of the agency. Given the pack nature of the press, more can be expected.
5. The personal integrity of the chairman of the agency has been questioned in the Capitol, with some describing him as a “megalomaniac” who is damaging the agency that he was so instrumental in establishing.
On the other hand, CIRM has appointed a well-regarded scientist, Zach Hall, as its interim president and adopted a conflict of interest code for its employees. Creating a new agency is a slow and tedious business, so it may be unreasonable to expect much more. CIRM yesterday, however, touted its progress by saying “we have now held 13 open public meetings in just 13 weeks.” Holding a meeting is about process as opposed to accomplishment, a fact that the businessmen and women on the Oversight Committee do not need to be reminded of.
The California Institute for Regenerative Medicine was certain to face controversy and opposition during its infancy just as it will during its entire existence. But some sort of honeymoon normally would have been expected. The promise of finding cures or treatments for everything ranging from diabetes to cancer is tremendously alluring. The agency also was expected to make California the stem cell capital of the world, creating jobs, attracting talent and generating prestige for the state.
But today the agency is under heavy assault. It is one thing to irritate the sometimes toothless watch dog groups. It is another to antagonize heavyweight lawmakers.
CIRM now must focus much of its energy in rebuilding support in the Capitol. It will need to do everything possible to prevent a constitutional amendment from being placed on the ballot to tighten controls over the agency. The last thing the agency needs is a statewide election contest over matters that should have been dealt with more skillfully. The sooner the issue is put to rest the better.
Such an effort in the Capitol will cost money and time, particularly time lost because of the distractions from the difficult and important business of creating a new agency.
A month ago, it certainly would have been much easier to discuss legislative concerns and arrive at solutions instead of dueling with press releases and nationwide Internet campaigns. No doubt some of the folks on the fringe would have never been satisfied short of taking their pitch to the California Supreme Court. But other critics seemed to be looking for some overt action as an assurance that their concerns would receive a serious hearing. That did not seem to be forthcoming.
In the wake of the jubilation over the passage of Prop. 71 less than five months ago, few would have foreseen the current state of affairs. Let's hope a new path can be quickly charted.
-----
We welcome and will publish comments on CIRM or the failings of this blog. Please send them to djensen@californiastemcellreport.com.
But the truly sad part about it is that much of the pain was unnecessary and is now hobbling an agency that was born with great expectations.
Here is a partial scorecard:
1. The agency now faces a potential ballot fight, possibly as early as next fall, if a proposed constitutional amendment to tighten oversight passes in time.
2. The bond market, where the agency hopes to raise billions, is judged to be skittish about any offerings given the current state of litigation against the agency.
3. Powerful supporters in the California legislature are now wary and suspicious, aligning themselves with those who would be ecstatic if the agency vanished from the earth.
4. Critical and nagging questions have been aired in the media across the country concerning the conduct of the agency. Given the pack nature of the press, more can be expected.
5. The personal integrity of the chairman of the agency has been questioned in the Capitol, with some describing him as a “megalomaniac” who is damaging the agency that he was so instrumental in establishing.
On the other hand, CIRM has appointed a well-regarded scientist, Zach Hall, as its interim president and adopted a conflict of interest code for its employees. Creating a new agency is a slow and tedious business, so it may be unreasonable to expect much more. CIRM yesterday, however, touted its progress by saying “we have now held 13 open public meetings in just 13 weeks.” Holding a meeting is about process as opposed to accomplishment, a fact that the businessmen and women on the Oversight Committee do not need to be reminded of.
The California Institute for Regenerative Medicine was certain to face controversy and opposition during its infancy just as it will during its entire existence. But some sort of honeymoon normally would have been expected. The promise of finding cures or treatments for everything ranging from diabetes to cancer is tremendously alluring. The agency also was expected to make California the stem cell capital of the world, creating jobs, attracting talent and generating prestige for the state.
But today the agency is under heavy assault. It is one thing to irritate the sometimes toothless watch dog groups. It is another to antagonize heavyweight lawmakers.
CIRM now must focus much of its energy in rebuilding support in the Capitol. It will need to do everything possible to prevent a constitutional amendment from being placed on the ballot to tighten controls over the agency. The last thing the agency needs is a statewide election contest over matters that should have been dealt with more skillfully. The sooner the issue is put to rest the better.
Such an effort in the Capitol will cost money and time, particularly time lost because of the distractions from the difficult and important business of creating a new agency.
A month ago, it certainly would have been much easier to discuss legislative concerns and arrive at solutions instead of dueling with press releases and nationwide Internet campaigns. No doubt some of the folks on the fringe would have never been satisfied short of taking their pitch to the California Supreme Court. But other critics seemed to be looking for some overt action as an assurance that their concerns would receive a serious hearing. That did not seem to be forthcoming.
In the wake of the jubilation over the passage of Prop. 71 less than five months ago, few would have foreseen the current state of affairs. Let's hope a new path can be quickly charted.
-----
We welcome and will publish comments on CIRM or the failings of this blog. Please send them to djensen@californiastemcellreport.com.
Coming Up Friday
Look for a report here Friday on the bids for the new permanent headquarters for CIRM. Semi-complete coverage promised.
"Welcoming" and News Coverage
The California stem cell agency and one of its leading critics this week were, for once, in something of an agreement. They both “welcomed” the participation of two California state senators in the agency's business.
But that was about as far as it went.
Here are links to some of the stories this morning on the stem cell agency, the proposed constitutional amendment and other proposals. We are also carrying on this blog the joint press release from the two California senators, the statement from Robert Klein and Ed Penhoet and the statement from the Center on Genetics and Society because not all of them are available on their various web sites at the time of this writing.
See the CIRM statement and the one from Genetics and Society for their "welcoming" comments.
Megan Garvey, Los Angeles Times; Carl Hall, San Francisco Chronicle; Bill Ainsworth, San Diego Union Tribune.
But that was about as far as it went.
Here are links to some of the stories this morning on the stem cell agency, the proposed constitutional amendment and other proposals. We are also carrying on this blog the joint press release from the two California senators, the statement from Robert Klein and Ed Penhoet and the statement from the Center on Genetics and Society because not all of them are available on their various web sites at the time of this writing.
See the CIRM statement and the one from Genetics and Society for their "welcoming" comments.
Megan Garvey, Los Angeles Times; Carl Hall, San Francisco Chronicle; Bill Ainsworth, San Diego Union Tribune.
SENATORS ORTIZ AND RUNNER
INTRODUCE LEGISLATIVE PACKAGE TO
PROTECT PUBLIC’S INVESTMENT IN STEM CELL RESEARCH
SACRAMENTO – Senator Deborah Ortiz (D-Sacramento) and Senator George Runner (R-Antelope Valley) today announced they will introduce two bills and a Senate Constitutional Amendment to ensure public accountability in the implementation of Proposition 71, the stem-cell research initiative approved by voters in November.
“To maintain the public’s confidence, the integrity of this important research and California’s significant financial investment, we must make sure meetings are open to public scrutiny, strict conflict-of-interest and economic disclosure standards are developed, patients’ rights are protected and the state receives a fair financial return on its generous investment,” Ortiz said.
“The voters of California did not vote for Proposition 71 so that biomedical companies get a windfall of billions of tax dollars with little or no accountability,” Runner said. “It’s critical that we establish the highest ethical conflict of interest standards, true operating transparency, and a direct benefit to Californians from their $6 billion investment.”
Proposition 71, the California Stem Cell Research and Cures Act, provides $3 billion in general obligation bonds to fund stem cell research and research facilities in California. The act established the California Institute for Regenerative Medicine, led by the Independent Citizen’s Oversight Committee (ICOC), to award grants and loans for stem cell research and research facilities.
Under the Ortiz-Runner constitutional amendment, employees of the Institute, the ICOC and members of the working or advisory groups will be subject to conflict-of-interest and financial disclosure requirements similar to those that govern California public officials and individuals serving or employed by the National Institute of Health. The legislation also will require that all meetings and records are subject to state open meeting and public record laws.
The measure will include strict guidelines to ensure clinical treatments, products or services resulting from the biomedical research are made available to California citizens and public health programs at affordable
costs. It also will require that all financial arrangements ensure the state recoups legal and administrative costs and a share of royalties or licensing revenues derived from the development of clinical treatments, products or services.
Ortiz and Runner also will jointly author legislation to provide for a three-year moratorium on multiple donations of eggs solely for research purposes. That bill will expressly prohibit payment in excess of reimbursement and require providers of fertility treatment services to give patients timely and appropriate information so they may make informed choices regarding the disposition of any human eggs remaining after fertility treatment. Fertility treatment providers also will be required to provide standard disclosures of medical risks, developed by the Department of Health Services, to women considering undergoing fertility treatment.
A second bill will require the State Auditor to conduct periodic financial and program audits of the ICOC and the Institute.
Because of provisions in Proposition 71, the Legislature may only make changes “in furtherance of” the initiative by receiving approval from voters. Legislative constitutional amendments require two-thirds majority approval from both the Assembly and the Senate to qualify for the ballot.
The Senators believe the provisions dealing with egg donations, patient protections and audits are “supplemental to” Proposition 71, and can be enacted by a simple majority vote of the Legislature.
“These measures will uphold our promise to the public that Proposition 71 is implemented in an open, thoughtful and deliberative manner,” Ortiz said. “We owe this public accountability to millions of Americans afflicted by conditions that may some day be cured through stem cell research, and to the taxpayers of California who are funding this critical research.”
# # #
Statement by Robert Klein, Chair
Ed Penhoet, Vice Chair
Independent Citizens’ Oversight Committee
For the California Institute for Regenerative Medicine
Regarding the News Conference Today in Sacramento by
State Senators Deborah Ortiz and George Runner
Wednesday, March 16, 2005
Emeryville, CA – Robert Klein and Ed Penhoet, Chair and Vice Chair, respectively, of the Independent Citizens’Oversight Committee for the California Institute for Regenerative Medicine, made the following statement regarding today’s news conference in Sacramento by State Senators Deborah Ortiz and George Runner:
“First of all, we want to acknowledge and express our appreciation to Senator Ortiz for her leadership in the area of stem cell research in Sacramento and throughout the State of California.
Senator Ortiz and the California Institute for Regenerative Medicine share the same goal: to support stem cell research and to ensure that California leads the way for finding cures for people with disease, illness and injury.
60 % of California voters cast their ballots last Fall, and more than 70 patient and disease advocacy groups, and medical, research and scientific organizations affirmed their hope in the promise of stem cell cures. Their votes were not only an expression of hope, but also a vote of confidence that the Prop. 71 initiative contains sufficient governance, oversight and accountability mechanisms to address the very same issues Senators Ortiz and Runner discussed today.
The initiative anticipated and the Institute is structured to provide significant conflict of interest regulations AND medical and ethical standards, especially those that protect women, based upon recognized and respected standards adopted by the National Institutes of Health. Those regulations and standards are in process of being developed by the Institute’s governing board, the ICOC, its subcommittees and working groups. The public and all interested parties have been, will be – and should be – active participants in this process. In addition, the National Academies of Sciences and Medicine are currently in the process of developing model medical and ethical standards for stem cell research – specifically to meet California’s timeline -- which are due public in April and shall be taken into full consideration by the Institute and the public in the coming months. And, it is important to note, that there are federal regulations already in place that will apply to future research conducted with Prop 71 grants to ensure the appropriate protections for all patients.
In the short few months that this Institute has been in place, we have made significant progress towards setting appropriate and necessary conflict of interest rules for staff. The ICOC is committed to adopting stringent conflict of interest policies and medical and ethical standards – with input from the public. In fact, we have now held 13 open public meetings in just 13 weeks.
We welcome Senator Ortiz, Senator Runner and their colleagues’ participation in this ongoing process, and we look forward to collaborating together with members of the Legislature and the public in this important endeavor.
At the time same time, the voters of California sent a clear message: they entrusted the Institute’s governing board, which is comprised of 29 prominent Californians -- leaders in academia, science, medicine, research, patient advocacy and business -- to move forward with the work ahead. This Board is dedicated to addressing all and more of the issues addressed by Senators Ortiz and Runner today.”
# # #
Critics of Proposition 71 Welcome Reform ProposalCenter for Genetics and Society, Pro-Choice Alliance for Responsible Research support proposal by Sens. Ortiz and Runner
SACRAMENTO – Public interest critics of California’s new stem cell institute, which was created by Proposition 71, welcomed a reform proposal announced today by Senators Deborah Ortiz and George Runner.
“The voters of California passed Proposition 71 based on promises of widely available cures, high ethical standards, and public accountability. They did not vote for throwing out laws that prevent secret meetings and guard against conflicts of interest,” said Marcy Darnovsky, associate executive director of the Center for Genetics and Society.
“We’re glad to see the Senators stepping up to protect Californians, who are the investors in this multi-billion dollar experiment.”
The Center for Genetics and Society and the Pro-choice Alliance for Responsible Research – who both support embryonic stem cell research but were prominent critics of Proposition 71 both before and after the recent campaign – expressed their support and optimism for the proposal’s passage.
“The Ortiz-Runner proposal will bring the public accountability and openness that the authors of Proposition 71 deliberately left out,” added Susan Berke Fogel, director of the Pro-Choice Alliance for Responsible Research. A moratorium on multiple egg extraction is critical to protect women’s health, as long-term effects of the drugs used are yet not known.”
The legislators’ announcement follows last week’s joint informational hearing on implementation of Proposition 71, chaired by Senator Ortiz and Assemblymember Wilma Chan. The hearing addressed many of the issues that have been raised by public interest critics, including conflicts of interest, open meetings, egg extraction, diversity in employment and hiring, health disparities, and financial returns to California.
“I hope that the leadership of the Institute realizes that this proposal will strengthen – not hinder – their work,” said Jesse Reynolds, program director at the Center for Genetics and Society. “The Institute must retain the confidence of the voters to be effective.”For more information, see http://www.genetics-and-society.org/policies/california/ .
Wednesday, March 16, 2005
Odd Couple Tightens Oversight Efforts.
Biotech Reporter Paul Elias of The Associated Press wrote this afternoon about the latest effort to tighten control over the California stem cell agency.
His story began: "Two state senators with opposite views on stem cell research forged an odd political alliance Wednesday when they introduced a proposed constitutional amendment to 'reform' the new $3 billion California Institute for Regenerative Medicine, which is already facing two lawsuits seeking to put it out of business.
Sens. Deborah Ortiz, D-Sacramento, and George Runner, R-Lancaster, also introduced legislation banning for three years so-called 'multiple egg donations' from women who voluntarily submit to hormone injections to 'superovulate' in the name of research. If passed, that law would effectively prevent the agency from funding human cloning projects for medical research for three years."
The agency issued a statement a few minutes ago that said in part, "The initiative anticipated and the Institute is structured to provide significant conflict of interest regulations AND medical and ethical standards, especially those that protect women...."
"We welcome Senator Ortiz, Senator Runner and their colleagues’ participation in this ongoing process, and we look forward to collaborating together with members of the Legislature and the public in this important endeavor.
"At the time same time, the voters of California sent a clear message: they entrusted the Institute’s governing board, which is comprised of 29 prominent Californians -- leaders in academia, science, medicine, research, patient advocacy and business -- to move forward with the work ahead. This Board is dedicated to addressing all and more of the issues addressed by Senators Ortiz and Runner today.”
The legislative move, however, is certainly not good news for CIRM. We will have more on this subject Thursday morning.
His story began: "Two state senators with opposite views on stem cell research forged an odd political alliance Wednesday when they introduced a proposed constitutional amendment to 'reform' the new $3 billion California Institute for Regenerative Medicine, which is already facing two lawsuits seeking to put it out of business.
Sens. Deborah Ortiz, D-Sacramento, and George Runner, R-Lancaster, also introduced legislation banning for three years so-called 'multiple egg donations' from women who voluntarily submit to hormone injections to 'superovulate' in the name of research. If passed, that law would effectively prevent the agency from funding human cloning projects for medical research for three years."
The agency issued a statement a few minutes ago that said in part, "The initiative anticipated and the Institute is structured to provide significant conflict of interest regulations AND medical and ethical standards, especially those that protect women...."
"We welcome Senator Ortiz, Senator Runner and their colleagues’ participation in this ongoing process, and we look forward to collaborating together with members of the Legislature and the public in this important endeavor.
"At the time same time, the voters of California sent a clear message: they entrusted the Institute’s governing board, which is comprised of 29 prominent Californians -- leaders in academia, science, medicine, research, patient advocacy and business -- to move forward with the work ahead. This Board is dedicated to addressing all and more of the issues addressed by Senators Ortiz and Runner today.”
The legislative move, however, is certainly not good news for CIRM. We will have more on this subject Thursday morning.
The Lowering of Expectations
The interim president of the California stem cell agency has injected a touch of reality into the business of research funding.
According to reporter Laura Mecoy of The Sacramento Bee, “The state probably won't issue its first stem cell grants until the fall, nearly four months after its initial plans to begin giving out money in May, the program's interim president said Tuesday.
“In a conference call with reporters, Zach Hall said the May deadline was an 'early hope' that didn't include the time needed to adopt grant guidelines and appoint a committee to review the grant applications.” Mecoy wrote.
Megan Garvey of the Los Angeles Times emphasized another angle having to do with the need to create regional stem cell research facilities. That tied into UCLA's announcement it will spend $20 million creating a new stem cell research facility.
According to reporter Laura Mecoy of The Sacramento Bee, “The state probably won't issue its first stem cell grants until the fall, nearly four months after its initial plans to begin giving out money in May, the program's interim president said Tuesday.
“In a conference call with reporters, Zach Hall said the May deadline was an 'early hope' that didn't include the time needed to adopt grant guidelines and appoint a committee to review the grant applications.” Mecoy wrote.
Megan Garvey of the Los Angeles Times emphasized another angle having to do with the need to create regional stem cell research facilities. That tied into UCLA's announcement it will spend $20 million creating a new stem cell research facility.
Roiling Undercurrents on Klein
Rumblings around the corridors in the Capitol in Sacramento are not kind to Robert Klein, the chairman of California's stem cell agency.
“Meglomaniac and liar” are a couple of the terms bandied about. These do not come from some disgruntled job seeker.
According to one source, “Legislators who have had any contact with Klein generally believe Klein is ICOC's (stem cell agency oversight committee) own worst enemy. He has driven everyone here nuts.
“He's spent the last couple of weeks visiting every legislator and legislative leader trying to get them” to call off last week's hearing into the agency.
“The feeling under the dome is the guy's a megalomaniac and a liar. No one agreed with his request to call off the hearing.
“If anything, it only made them mistrust him more and raised concerns about what is going on over there behind closed doors.”
Apparently that is what led to more aggressive than normal questioning of the interim president of the agency, Zach Hall, by members of the unusual legislative panel. Klein was absent and sent Hall.
Klein's behind-the-scenes lobbying came after he publicly stated he was willing to cooperate with legislators. It also came at the same time, that his allied nonprofit organization, Cures for California, sent out emails across the country to generate pressure on the legislature. The messages solicited recipients (presumably disease sufferers) to send emails to the Legislature or call seeking postponement of the legislative hearing.
The email said, “The hearing will inevitably generate press which could be damaging to the efforts of the Institute, and could impede their incredibly important work. The patient community needs your help!”
“Please mobilize within the next 12 hours!” the email exclaimed.
However, Klein earned good marks for having Hall testify at the hearing. “Congenial” was one word describing Hall although he did not ease all concerns.
In another way Hall was also a plus. “The less ICOC and the Institute are associated with Bob Klein, the better the public's confidence will be in their implementation of Prop 71,” a Capitol source said.
“Meglomaniac and liar” are a couple of the terms bandied about. These do not come from some disgruntled job seeker.
According to one source, “Legislators who have had any contact with Klein generally believe Klein is ICOC's (stem cell agency oversight committee) own worst enemy. He has driven everyone here nuts.
“He's spent the last couple of weeks visiting every legislator and legislative leader trying to get them” to call off last week's hearing into the agency.
“The feeling under the dome is the guy's a megalomaniac and a liar. No one agreed with his request to call off the hearing.
“If anything, it only made them mistrust him more and raised concerns about what is going on over there behind closed doors.”
Apparently that is what led to more aggressive than normal questioning of the interim president of the agency, Zach Hall, by members of the unusual legislative panel. Klein was absent and sent Hall.
Klein's behind-the-scenes lobbying came after he publicly stated he was willing to cooperate with legislators. It also came at the same time, that his allied nonprofit organization, Cures for California, sent out emails across the country to generate pressure on the legislature. The messages solicited recipients (presumably disease sufferers) to send emails to the Legislature or call seeking postponement of the legislative hearing.
The email said, “The hearing will inevitably generate press which could be damaging to the efforts of the Institute, and could impede their incredibly important work. The patient community needs your help!”
“Please mobilize within the next 12 hours!” the email exclaimed.
However, Klein earned good marks for having Hall testify at the hearing. “Congenial” was one word describing Hall although he did not ease all concerns.
In another way Hall was also a plus. “The less ICOC and the Institute are associated with Bob Klein, the better the public's confidence will be in their implementation of Prop 71,” a Capitol source said.
Tuesday, March 15, 2005
Robert Klein: The Missing Man
Was the most influential California legislator on stem cell issues unhappy with the Robert Klein's failure to appear at last week's hearing into the agency?
In response to an inquiry from the California Stem Cell Report, the office of Sen. Deborah Ortiz, D-Sacramento, said she encouraged Klein, who is chairman of the state stem cell agency, to appear. She assured him that his concerns about legal questions and litigation involving the California Institute for Regenerative Medicine could be overcome.
Ortiz, chair of the Senate Health Committee, “encouraged Mr. Klein to view the hearing as an opportunity to inform legislators and the public about the great strides the ICOC is making in this very difficult project: building the world's premier stem cell research institute from the ground up,” her office said.
“She assured Mr. Klein that she would instruct all witnesses and legislators to avoid discussing any issues that were pending before the court. She also encouraged Mr. Klein to attend the hearing with his attorney, who could advise him if there were any points that the attorney believed could jeopardize the litigation pending before the Supreme Court.
“Sen. Ortiz very strongly supports and campaigned for Proposition 71. She hopes the Attorney General is successful in his attempts to have the California Supreme Court take jurisdiction over the constitutional challenges that have been filed and resolve them quickly so that the implementation of this important research can begin and the cures we all hope will come from this significant public investment will be developed.”
The California Stem Cell Report's bottom line: State agencies are sued regularly. Their department heads, however, manage to come before legislative committees when requested. Is Klein different? The worst part about this is that his actions do not benefit the stem cell agency. As we pointed out previously, there is small profit in stiffing the legislature.
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We welcome and will publish comments on the stem cell agency or the failings of this blog. Please send them to djensen@californiastemcellreport.blogspot.com.
In response to an inquiry from the California Stem Cell Report, the office of Sen. Deborah Ortiz, D-Sacramento, said she encouraged Klein, who is chairman of the state stem cell agency, to appear. She assured him that his concerns about legal questions and litigation involving the California Institute for Regenerative Medicine could be overcome.
Ortiz, chair of the Senate Health Committee, “encouraged Mr. Klein to view the hearing as an opportunity to inform legislators and the public about the great strides the ICOC is making in this very difficult project: building the world's premier stem cell research institute from the ground up,” her office said.
“She assured Mr. Klein that she would instruct all witnesses and legislators to avoid discussing any issues that were pending before the court. She also encouraged Mr. Klein to attend the hearing with his attorney, who could advise him if there were any points that the attorney believed could jeopardize the litigation pending before the Supreme Court.
“Sen. Ortiz very strongly supports and campaigned for Proposition 71. She hopes the Attorney General is successful in his attempts to have the California Supreme Court take jurisdiction over the constitutional challenges that have been filed and resolve them quickly so that the implementation of this important research can begin and the cures we all hope will come from this significant public investment will be developed.”
The California Stem Cell Report's bottom line: State agencies are sued regularly. Their department heads, however, manage to come before legislative committees when requested. Is Klein different? The worst part about this is that his actions do not benefit the stem cell agency. As we pointed out previously, there is small profit in stiffing the legislature.
--------------
We welcome and will publish comments on the stem cell agency or the failings of this blog. Please send them to djensen@californiastemcellreport.blogspot.com.
Monday, March 14, 2005
California Stem Cell 101 -- Must Reading
It may not be everything you want to know about the current state of affairs with the California stem cell agency, but it is exceedingly close.
It is an excellent background paper prepared for last week's legislative hearing into the California Institute for Regenerative Medicine. It explains the ongoing issues in a straight-forward and evenhanded manner and is must reading for anyone who wants a clear overview of the agency.
The report also included questions that could be addressed by the agency.
They include:
“Whether pegging salaries for ICOC and Institute staff to the University of California and private research institutes is a reasonable guideline and whether the size and prestige of Proposition 71’s research program may enable the ICOC and Institute to attract top scientific and administrative talent without paying the highest salaries.”
“In cases where deliberations of the ICOC and its working groups are conducted in closed session, what record of decisionmaking will be accessible to the public to enable public participation in decisions of the ICOC and its working groups.”
“Whether the ICOC should apply recently adopted NIH standards prohibiting ownership of biotechnology and pharmaceutical company by senior employees to employees of the ICOC and the Institute."
“Whether statements of economic and other interests completed by Proposition 71 working group members should be accessible to the public, as are Form 700s under the Political Reform Act.”
The full text of the background paper follows in a separate item below. It did not carry the name of its author, although normally such documents are prepared by legislative committee staff.
It is an excellent background paper prepared for last week's legislative hearing into the California Institute for Regenerative Medicine. It explains the ongoing issues in a straight-forward and evenhanded manner and is must reading for anyone who wants a clear overview of the agency.
The report also included questions that could be addressed by the agency.
They include:
“Whether pegging salaries for ICOC and Institute staff to the University of California and private research institutes is a reasonable guideline and whether the size and prestige of Proposition 71’s research program may enable the ICOC and Institute to attract top scientific and administrative talent without paying the highest salaries.”
“In cases where deliberations of the ICOC and its working groups are conducted in closed session, what record of decisionmaking will be accessible to the public to enable public participation in decisions of the ICOC and its working groups.”
“Whether the ICOC should apply recently adopted NIH standards prohibiting ownership of biotechnology and pharmaceutical company by senior employees to employees of the ICOC and the Institute."
“Whether statements of economic and other interests completed by Proposition 71 working group members should be accessible to the public, as are Form 700s under the Political Reform Act.”
The full text of the background paper follows in a separate item below. It did not carry the name of its author, although normally such documents are prepared by legislative committee staff.
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