Monday, November 13, 2006
Not Dead Yet
In recent days, the California Stem Cell Report has been performing unspeakable acts involving the innards of one particular sailboat. Thus we have not been posting as frequently as the hundreds of thousands of readers (that is bit of hyperbole) might like. But never fear. We are not dead yet. Hot stuff – or maybe not-so-hot stuff – will be forthcoming in the next few days. Cheers to all.
Wednesday, November 08, 2006
Major Conflicts of Interest, Picayune Details
Sometimes tiny details tell us more about the nature of things than a panoramic perspective.
Such was the case last month at a meeting of the CIRM Oversight Committee when it considered what appeared to be a routine, previously discussed issue. We wrote about it then, noting that it illustrates the powerful nature of the built-in conflicts-of-interest involving CIRM.
The matter has come up again in the form of a comment on the proposed regulation offered by the Oversight Committee. The following was written by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights. The letter is addressed to CIRM as part of the official state process for adopting regulations. We quote it verbatim.
"I am writing to object to the removal at the October Independent Citizens' Oversight Committee meeting of the last sentence of SECTION 100309, Press Release Requirements of the Nonprofit Intellectual Property Policy. The sentence read: 'In the event CIRM wishes to participate in a joint press release, the grantee will coordinate with the CIRM Communications officer.'
"According to the Initial Statement of Reasons, 'This regulation is necessary so the CIRM is apprised of current significant developments regarding CIRM-funded research and ensure proper attribution to the CIRM and the State of California for the CIRM-funded activity.'
"Without the sentence, there is no way of ensuring that CIRM and the State of California receive proper attribution for CIRM-funded research in news releases.
"Section 100309 was approved twice by the ICOC. The regulation received no comments from the public during a thorough review of the regulations conducted by the IP Task Force and CIRM staff during the summer. During that process public comment was appropriately considered on other aspects of the policy and the IP regulations were modified taking that comment into account as mandated by the Office of Administrative Law procedures.
"The role of the ICOC at the October meeting should have been simply to make sure that those modifications were appropriate and took public comment into account. It was not appropriate to raise new issues that had been settled. Removing a sentence that had been approved twice by the board was at best arbitrary and capricious.
"More troublesome was the motivation for the removal. The action came on a motion from David Baltimore. Unfortunately the transcript of the meeting was not expected to be available before the end of the period for public comment.
"However, my notes show that Baltimore expressed concern that the requirement to co-ordinate with CIRM's Communications Officer would place a burden on universities. Rather than acting in the interests of all Californians, he was clearly acting in what he perceived to be the interest of the institution he represents. This sort of behavior does not bode well if one expects ICOC members to live up to the committee's name, 'independent' and truly act in the interests of all Californians rather than the institutions they represent."
Such was the case last month at a meeting of the CIRM Oversight Committee when it considered what appeared to be a routine, previously discussed issue. We wrote about it then, noting that it illustrates the powerful nature of the built-in conflicts-of-interest involving CIRM.
The matter has come up again in the form of a comment on the proposed regulation offered by the Oversight Committee. The following was written by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights. The letter is addressed to CIRM as part of the official state process for adopting regulations. We quote it verbatim.
"I am writing to object to the removal at the October Independent Citizens' Oversight Committee meeting of the last sentence of SECTION 100309, Press Release Requirements of the Nonprofit Intellectual Property Policy. The sentence read: 'In the event CIRM wishes to participate in a joint press release, the grantee will coordinate with the CIRM Communications officer.'
"According to the Initial Statement of Reasons, 'This regulation is necessary so the CIRM is apprised of current significant developments regarding CIRM-funded research and ensure proper attribution to the CIRM and the State of California for the CIRM-funded activity.'
"Without the sentence, there is no way of ensuring that CIRM and the State of California receive proper attribution for CIRM-funded research in news releases.
"Section 100309 was approved twice by the ICOC. The regulation received no comments from the public during a thorough review of the regulations conducted by the IP Task Force and CIRM staff during the summer. During that process public comment was appropriately considered on other aspects of the policy and the IP regulations were modified taking that comment into account as mandated by the Office of Administrative Law procedures.
"The role of the ICOC at the October meeting should have been simply to make sure that those modifications were appropriate and took public comment into account. It was not appropriate to raise new issues that had been settled. Removing a sentence that had been approved twice by the board was at best arbitrary and capricious.
"More troublesome was the motivation for the removal. The action came on a motion from David Baltimore. Unfortunately the transcript of the meeting was not expected to be available before the end of the period for public comment.
"However, my notes show that Baltimore expressed concern that the requirement to co-ordinate with CIRM's Communications Officer would place a burden on universities. Rather than acting in the interests of all Californians, he was clearly acting in what he perceived to be the interest of the institution he represents. This sort of behavior does not bode well if one expects ICOC members to live up to the committee's name, 'independent' and truly act in the interests of all Californians rather than the institutions they represent."
Monday, November 06, 2006
Klein: A Man With Two Hats
John M. Simpson, stem cell project director for the strong>Foundation for Taxpayer and Consumers Rights, has this to say about the endorsement of a candidate for California lieutenant governor by the state's stem cell chairman.
"Bob Klein needs to decide if he wants to be a stem cell advocate or the head of California's stem cell agency.Simpson's comment came as a result of a query from the California Stem Cell Report.
"Wearing these two hats at the same time does a disservice to both the California Institute for Regenerative Medicine and Americans for Stem Cell Therapies and Cures."
Stem Cell Snippets: Galas to Free Stem Cell Movies
Here are some short notes and links to items connected to California stem cell issues.
Shades of Arnold -- The celebrated stem cell fund raiser last spring in San Francisco has not yet resulted in one dollar for CIRM. The agency told the California Stem Cell Report that it knows of no reason for the delay or the size of the contribution to CIRM, if one is forthcoming.
IP – CIRM's IP Task Force meets this Thursday in La Jolla to wrestle with rules for sharing possible stem cell booty with business. The proposed IP policy says, "There are no extant policy models that capture in entirety the intent of the State of California in its objectives to fund the for-profit research sector and provide a return to the state. As a consequence, this proposed policy is a unique synthesis of best practices and recommendations from funding agencies and foundations around the world." The Task Force may hear from representatives of businesses in the San Diego area. You can participate in the session at offsite locations at San Carlos in the Bay Area and UC Irvine. Here is the agenda.
Good Old Days – Writer Paul Billings in New Scientist magazine longs for the days when the feds reigned supreme. He remains fond of national funding models, despite their failings in ESC research. And he says Prop. 71's "most visible outcome to date has been the creation of a new bureaucracy." We should note that CIRM's staff totals about 20, probably less than the staff of the magazine.
Free Stem Cell Movies – A stellar cast of San Diego stem cell scientists with cameo performances from two CIRM character actors is featured in a 17-chapter ESC video serial available on the California Institute for Telecommunications and Information Technology website. The videos are from an invitation-only conference called "Stem Cell Meeting on the Mesa." Lots of science, plenty on ethics and a bit on policy and business.
Shades of Arnold -- The celebrated stem cell fund raiser last spring in San Francisco has not yet resulted in one dollar for CIRM. The agency told the California Stem Cell Report that it knows of no reason for the delay or the size of the contribution to CIRM, if one is forthcoming.
IP – CIRM's IP Task Force meets this Thursday in La Jolla to wrestle with rules for sharing possible stem cell booty with business. The proposed IP policy says, "There are no extant policy models that capture in entirety the intent of the State of California in its objectives to fund the for-profit research sector and provide a return to the state. As a consequence, this proposed policy is a unique synthesis of best practices and recommendations from funding agencies and foundations around the world." The Task Force may hear from representatives of businesses in the San Diego area. You can participate in the session at offsite locations at San Carlos in the Bay Area and UC Irvine. Here is the agenda.
Good Old Days – Writer Paul Billings in New Scientist magazine longs for the days when the feds reigned supreme. He remains fond of national funding models, despite their failings in ESC research. And he says Prop. 71's "most visible outcome to date has been the creation of a new bureaucracy." We should note that CIRM's staff totals about 20, probably less than the staff of the magazine.
Free Stem Cell Movies – A stellar cast of San Diego stem cell scientists with cameo performances from two CIRM character actors is featured in a 17-chapter ESC video serial available on the California Institute for Telecommunications and Information Technology website. The videos are from an invitation-only conference called "Stem Cell Meeting on the Mesa." Lots of science, plenty on ethics and a bit on policy and business.
Sunday, November 05, 2006
An Extraordinary Agency (CIRM), Now Two Years Old
The California Institute for Regenerative Medicine – the state stem cell agency – marks its second anniversary this month.
The $6 billion agency was created when 59 percent of California voters approved Prop. 71 in 2004. A spokesman for CIRM said no special activities are planned for the birthday, which could be considered to be Nov. 2, the date of the 2004 election, or later in the month, when the results of the election were actually legally certified.
Without attempting a major overview of the agency's work, it is safe to say that it has made substantial progress towards its goal of turning stem cells into cures. It has improved its operations substantially from those difficult days of 2005. It has funded training programs to develop more stem cell scientists. And it is on the verge of making its first research grants and financing new laboratories.
The endeavor – believed to be the largest single source of embryonic stem cell funding in the world – has attracted international attention. A number of states in this country are attempting to emulate the effort in one way or another. CIRM also has gone beyond national ESC research standards and become the benchmark for ESC research standards in this country.
That said, life at CIRM is not all hunky dory. It faces considerable challenges, as readers of the California Stem Cell Report know. But the folks at CIRM are engaged in an enterprise that comes along only once in a lifetime. Although the details of the work at the agency are sometimes pedestrian, CIRM staffers are on the cutting edge of an unprecedented effort that ranges over new ground in science, medicine, religion, ethics, government, politics and business. They should take great pride in what they are attempting to do.
We wish the entire tiny band of CIRMies – all 20 or so -- a grand and happy birthday.
The $6 billion agency was created when 59 percent of California voters approved Prop. 71 in 2004. A spokesman for CIRM said no special activities are planned for the birthday, which could be considered to be Nov. 2, the date of the 2004 election, or later in the month, when the results of the election were actually legally certified.
Without attempting a major overview of the agency's work, it is safe to say that it has made substantial progress towards its goal of turning stem cells into cures. It has improved its operations substantially from those difficult days of 2005. It has funded training programs to develop more stem cell scientists. And it is on the verge of making its first research grants and financing new laboratories.
The endeavor – believed to be the largest single source of embryonic stem cell funding in the world – has attracted international attention. A number of states in this country are attempting to emulate the effort in one way or another. CIRM also has gone beyond national ESC research standards and become the benchmark for ESC research standards in this country.
That said, life at CIRM is not all hunky dory. It faces considerable challenges, as readers of the California Stem Cell Report know. But the folks at CIRM are engaged in an enterprise that comes along only once in a lifetime. Although the details of the work at the agency are sometimes pedestrian, CIRM staffers are on the cutting edge of an unprecedented effort that ranges over new ground in science, medicine, religion, ethics, government, politics and business. They should take great pride in what they are attempting to do.
We wish the entire tiny band of CIRMies – all 20 or so -- a grand and happy birthday.
Klein and the Endorsement: CIRM Says No Comment
The California stem cell agency has no comment on the allegations that its chairman could be violating the law with his endorsement of a candidate for California lieutenant governor as detailed in the item below.
There are a number of interpretations of that sort of response. One is that the agency does not disagree with the assertion of illegality. Another is that they do disagree but for unknown reasons they choose not to share that belief with the public. Still another is that they do not know whether Klein's actions are illegal but they do not want to acknowledge their ignorance in public. And still another is that they do not want to engage in an exchange with an organization that sometimes has been held in low regard at CIRM. And yet one more is that they do not want to bring any more attention to the allegations by appearing to take them seriously. Or perhaps a combination of those considerations is the reason for the no comment response.
There are a number of interpretations of that sort of response. One is that the agency does not disagree with the assertion of illegality. Another is that they do disagree but for unknown reasons they choose not to share that belief with the public. Still another is that they do not know whether Klein's actions are illegal but they do not want to acknowledge their ignorance in public. And still another is that they do not want to engage in an exchange with an organization that sometimes has been held in low regard at CIRM. And yet one more is that they do not want to bring any more attention to the allegations by appearing to take them seriously. Or perhaps a combination of those considerations is the reason for the no comment response.
Saturday, November 04, 2006
Does Klein's Endorsement of a Political Candidate Violate the Law?
The Biopolitical Times – the blog of the Center for Genetics and Society – has suggested that California stem cell Chairman Robert Klein has committed an illegal act by endorsing the Democratic candidate for California lieutenant governor.
Jesse Reynolds, a Center official who has followed CIRM since its inception, wrote:
Reynolds wrote:
Jesse Reynolds, a Center official who has followed CIRM since its inception, wrote:
"It's my understanding that as an appointed state official, he is prohibited from endorsing candidates for office."Reynolds quoted a California State Supreme Court decision, Stanson v. Mott, as setting limits on electioneering by appointed officials. It said,
"A fundamental precept of this nation's democratic electoral process is that the government may not 'take sides' in election contests or bestow an unfair advantage on one of several competing factions. A principal danger feared by our country's founders lay in the possibility that the holders of governmental authority would use official power improperly to perpetuate themselves, or their allies, in office...; the selective use of public funds in election campaigns, of course, raises the specter of just such an improper distortion of the democratic electoral process."Klein, of course, said he was endorsing John Garamendi as a private citizen – not as head of the Oversight Committee for the stem cell agency. If elected lieutentant governor, Garamendi would have the ability to appoint as many as five members to the 29-member Oversight Committee.
Reynolds wrote:
"His attempt at endorsing Garamendi as something other than his official capacity - chairman of the board of California's $3 billion stem cell program - is disingenuous and wrong. Everyone knows what his day job is. Klein's action is the equivalent of Leon Kass, then chair of the President's Council on Bioethics, lobbying Congress on stem cell research as a "private citizen" - a move that wasReynolds also cited an earlier item on the California Stem Cell Report which reported that Klein is head of Americans for Stem Cell Therapies and Cures, a lobbying and political action group. Reynolds continued:
roundly criticized by stem cell research advocates."
"Klein chaired a similar advocacy organization, the California Research and Cures Coalition, just after the passage of Proposition 71. He resigned that post [PDF] under pressure. This is more egregious, in that the new organization is a lobbying outfit, not just an 'education' nonprofit. Moreover, it advocates for candidates that will appoint the board members whose support Klein needs to stay on in his official capacity. Klein must choose: Is he an advocate, or a public servant? He should resign from one of the two boards."We are querying CIRM concernings its position on whether Klein can legally endorse candidates for state office. However, he and other state officials regularly make contributions to candidates for state office, an act that is tantamount to an endorsement and which is apparently not banned by state law.
Friday, November 03, 2006
The Scientist Magazine: WARF Patents Over-Reaching
The prestigious magazine, The Scientist, has taken on WARF and its stem cell ownership claims in two pieces that denounce the WARF patents as absurd and harmful to scientific research.
Richard Gallagher, editor of the magazine, and Glenn McGee , director of the Alden March Bioethics Institute in New York state, wrote an editorial and column, respectively, on the subject.
Gallagher said:
Richard Gallagher, editor of the magazine, and Glenn McGee , director of the Alden March Bioethics Institute in New York state, wrote an editorial and column, respectively, on the subject.
Gallagher said:
"Patents are a good thing. In general, they promote progress by encouraging research and development with incentives. But sometimes, they over-reach, and they impede progress rather than help it. This is one of those cases. The WARF patents point up the sometimes uncomfortable conflict between intellectual property rights and scientific freedom that many of our readers often feel as they find their way in the funding environment of the 21st century."McGee wrote:
"So can someone own the cells that make up what is important about a human embryo? And if so, do we have to pay them every time we make our own embryonic cells, every time we make a medicine or other innovation from embryonic cells, and even when we use the cells to teach?He continued:
"Basically, if it looks like an embryonic cell, you'd better pay up. And if you try to make something out of your own embryo - yes, the one you made with your own body, from your own body - well, hope you have good lawyers."
"In one among many of its attempts to avoid what could and should be a reversal of these patents stemming from the decision to review them, Wisconsin's Governor Jim Doyle has announced that companies who fund work at universities and nonprofits in that state will not have to pay any licensing fees. Previous attempts to ameliorate the problem have been more aggressive: offering to provide the cell lines at lower prices or to cross-license in a friendly way, for example. It wasn't enough for Californians, and now it appears it won't be enough to stop right-thinking people everywhere from filing suit, on moral grounds if nothing else.
"The protection of patents is supposed to extend to 'things under the sun made by man.' There has yet to be a serious challenge to the absurdity of patents on disease genes, and the even more absurd notion that the ability to find, to discover, constitutive parts of an embryo means that you own them."
CIRM Ripped for Secrecy
The California stem cell agency, which has sworn to uphold the highest standards of openness, has come under fire in the op-ed pages of The Sacramento Bee for its secrecy in the process of reviewing applications for tens of millions of public dollars in research grants.
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, took on CIRM. He wrote:
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, took on CIRM. He wrote:
"Despite mouthing high-minded slogans, the institute's leaders frequently miss the mark whenever there is a clear opportunity to transact the public's business in public."Simpson continued:
"No useful purpose is served by CIRM's penchant for secrecy. It should disclose who applied and where they are from, enabling all concerned to track awards and dispel worries about discrimination.
"There's no need to worry about embarrassing somebody because he didn't get a grant. CIRM is planning to fund only 12.9 percent of the applicants."Missing this cut is no big deal. Scientists need to develop thicker skins if they want to use public money for their work, and CIRM needs to let the sun shine in.
"Bottom line: They want our money. They must tell us who they are and ask for it in public."
Klein Says $150 Million Loan Up for Approval Later This Month
California stem cell Chairman Robert Klein has released a statement on Gov. Arnold Schwarzeneger's failure to fulfill – so far – his $150 million promise to bail out the fiscally strapped California stem cell agency.
More than three months ago the governor vowed to provide the money "now." Aides told CIRM that funds would be forthcoming by mid August.
Klein's statement did not explain why the delay has occurred but said a meeting of the CIRM Finance Committee will be held later this month to finalize the loan. Klein said the deal was "extraordinarily complex."
More than three months ago the governor vowed to provide the money "now." Aides told CIRM that funds would be forthcoming by mid August.
Klein's statement did not explain why the delay has occurred but said a meeting of the CIRM Finance Committee will be held later this month to finalize the loan. Klein said the deal was "extraordinarily complex."
Wednesday, November 01, 2006
Stem Cell Politics: Beware the ESC Troglodytes
At one point stem cell advocates deplored the intrusion of politics into stem cell research. They pointed to President Bush's intrusion into the science as an example of how harmful it could be.
No more. Stem cell advocates are now hammering away at the need to throw out the nonbelievers and defeat the ESC troglodytes.
A fair amount has already been written about the stem cell political push elsewhere in the country. But the issue has surfaced in a few races in California as well.
One of the political enterprises involved is Robert Klein's Americans for Stem Cell Therapies and Cures, whose headquarters are located in his business offices. (Klein, of course, is also the chairman of the California stem cell agency.)
The Americans group has produced a report card on the California statewide races from governor to controller, but does not rate California legislative or congressional candidates. Singled out for special attention is State Sen. Tom McClintock, a Republican who is running for lieutenant governor.
Reporter Rebecca Veseley of the Contra Costa Times covered a news conference this week during which Klein disparaged McClintock as representing "the far right." Klein noted that the lieutenant governor can make five apppointments to the Oversight Committee for CIRM. He said that could place McClintock in a position where he could damage stem cell research. A spokesman for McClintock said he would apppoint "taxpayer watchdogs who will demand accountability."
Klein's group is primarily pushing a national agenda, building mailing lists, arranging for speakers and drumming up voter turnout.
Klein also makes personal political contributions. We do not yet know the figures for this fall, but he contributed $5,000 last spring to Debra Bowen who defeated Deborah Ortiz, a longtime stem cell advocate, for the Democratic nomination for California secretary of state. Ortiz riled Klein with her insistence on greater accountability from CIRM, and he lambasted her publicly "as an ongoing threat" shortly before the primary election last June.
No more. Stem cell advocates are now hammering away at the need to throw out the nonbelievers and defeat the ESC troglodytes.
A fair amount has already been written about the stem cell political push elsewhere in the country. But the issue has surfaced in a few races in California as well.
One of the political enterprises involved is Robert Klein's Americans for Stem Cell Therapies and Cures, whose headquarters are located in his business offices. (Klein, of course, is also the chairman of the California stem cell agency.)
The Americans group has produced a report card on the California statewide races from governor to controller, but does not rate California legislative or congressional candidates. Singled out for special attention is State Sen. Tom McClintock, a Republican who is running for lieutenant governor.
Reporter Rebecca Veseley of the Contra Costa Times covered a news conference this week during which Klein disparaged McClintock as representing "the far right." Klein noted that the lieutenant governor can make five apppointments to the Oversight Committee for CIRM. He said that could place McClintock in a position where he could damage stem cell research. A spokesman for McClintock said he would apppoint "taxpayer watchdogs who will demand accountability."
Klein's group is primarily pushing a national agenda, building mailing lists, arranging for speakers and drumming up voter turnout.
Klein also makes personal political contributions. We do not yet know the figures for this fall, but he contributed $5,000 last spring to Debra Bowen who defeated Deborah Ortiz, a longtime stem cell advocate, for the Democratic nomination for California secretary of state. Ortiz riled Klein with her insistence on greater accountability from CIRM, and he lambasted her publicly "as an ongoing threat" shortly before the primary election last June.
$150 Million Snared in 'Red Tape'?
"Red tape and election year politics" apparently have delayed Gov. Arnold Schwarzenegger's promised $150 million loan to the California stem cell agency, according to The Associated Press.
Reporter Paul Elias has written a follow on our report (see item below). Elias said:
Reporter Paul Elias has written a follow on our report (see item below). Elias said:
"'This is a unique and extremely complicated financial transaction with a lot of moving parts,' said California Department of Finance spokesman H.D Palmer. 'It has taken a little bit longer than anticipated, but nobody has been slow on this.'"Palmer's position is much different than that of Schwarzenegger in July when he indicated, in a politically timed announcement, that the money would be made available promptly. His aides also said they expected funds the paperwork to be completed in mid-August.
Saturday, October 28, 2006
Missing: Arnold's Promised $150 Million Stem Cell Loan
Last July, in the heat of the national debate about stem cell research, Gov. Arnold Schwarzenegger made headlines by promising $150 million to bail out the fiscally strapped California stem cell agency.
Today, more than three months later, the agency has not seen one dime of the promised loan despite the governor's July 21 statement that CIRM "need(s) the money now." Schwarzenegger said that it was "critical we take action" and that money should begin flowing "as soon possible."
The California Stem Cell Report queried both the governor's office and CIRM concerning Schwarzenegger's failure to provide the money. The governor's office has not responded to our request on Friday about what has blocked the cash. CIRM also has been less than informative.
Dale Carlson, spokesman for the agency, said that the State Department of Finance "needs to review the loan documents which are still being written," but declined to elaborate.
Unexplained was whether there is some problem with making the loan to CIRM, which one would think would be a fairly routine procedure that could be executed in less than three months. Unexplained also was the exact nature of the loan mechanism, which was not discussed in news reports at the time of the governor's announcement.
Anne Sheehan, an aide to the governor, told the CIRM Oversight Committee at the beginning of August that the loan amounted to "uncharted waters" for the state but that she expected action on it by the middle of August.
Since Schwarzenegger's politically exquisite timing of the loan announcement, which received worldwide attention, he has been involved in a re-election campaign in which he has built a commanding lead over his Democratic opponent, state Treasurer Phil Angelides. Perhaps the campaign has distracted Schwarzenegger's office from fulfilling the loan promise.
California stem cell Chairman Robert Klein alluded to the pressures of the campaign at a meeting of the CIRM Oversight Committee earlier this month. He indicated that the elections had made it difficult to hold a meeting of the CIRM Finance Committee, a special body created by Prop. 71, to approve issuance of CIRM bonds.
However, neither CIRM nor the governor's office explained if or why the Finance Committee would be involved in a loan between two state entities. Klein indicated that the Finance Committee, at its next meeting, would review more requests for bond anticipation notes, which are expected to be issued to private contributors to CIRM.
A July 20 press release by CIRM cited a section of Prop. 71 that appears to allow the state director of finance to provide funding to CIRM from the state's general fund if it is within the amount of unsold bonds authorized by the Finance Committee. That group has already approved $200 million in bonds, which have not been sold, so it would appear giving CIRM the $150 million is a simple ministerial act, but maybe not.
Klein said he hoped the Finance Committee could meet very soon after the fall elections, which will come a week from Tuesday.
The stem cell agency has been strapped for funds because of lawsuits that have blocked the issuance of state bonds that would fund it. It has operated, for the most part, on the basis of private contributions and loans since it began operations in late 2004. CIRM did not respond to a question from the California Stem Cell Report about whether the failure to provide the loan has created any financial difficulties at the agency.
Today, more than three months later, the agency has not seen one dime of the promised loan despite the governor's July 21 statement that CIRM "need(s) the money now." Schwarzenegger said that it was "critical we take action" and that money should begin flowing "as soon possible."
The California Stem Cell Report queried both the governor's office and CIRM concerning Schwarzenegger's failure to provide the money. The governor's office has not responded to our request on Friday about what has blocked the cash. CIRM also has been less than informative.
Dale Carlson, spokesman for the agency, said that the State Department of Finance "needs to review the loan documents which are still being written," but declined to elaborate.
Unexplained was whether there is some problem with making the loan to CIRM, which one would think would be a fairly routine procedure that could be executed in less than three months. Unexplained also was the exact nature of the loan mechanism, which was not discussed in news reports at the time of the governor's announcement.
Anne Sheehan, an aide to the governor, told the CIRM Oversight Committee at the beginning of August that the loan amounted to "uncharted waters" for the state but that she expected action on it by the middle of August.
Since Schwarzenegger's politically exquisite timing of the loan announcement, which received worldwide attention, he has been involved in a re-election campaign in which he has built a commanding lead over his Democratic opponent, state Treasurer Phil Angelides. Perhaps the campaign has distracted Schwarzenegger's office from fulfilling the loan promise.
California stem cell Chairman Robert Klein alluded to the pressures of the campaign at a meeting of the CIRM Oversight Committee earlier this month. He indicated that the elections had made it difficult to hold a meeting of the CIRM Finance Committee, a special body created by Prop. 71, to approve issuance of CIRM bonds.
However, neither CIRM nor the governor's office explained if or why the Finance Committee would be involved in a loan between two state entities. Klein indicated that the Finance Committee, at its next meeting, would review more requests for bond anticipation notes, which are expected to be issued to private contributors to CIRM.
A July 20 press release by CIRM cited a section of Prop. 71 that appears to allow the state director of finance to provide funding to CIRM from the state's general fund if it is within the amount of unsold bonds authorized by the Finance Committee. That group has already approved $200 million in bonds, which have not been sold, so it would appear giving CIRM the $150 million is a simple ministerial act, but maybe not.
Klein said he hoped the Finance Committee could meet very soon after the fall elections, which will come a week from Tuesday.
The stem cell agency has been strapped for funds because of lawsuits that have blocked the issuance of state bonds that would fund it. It has operated, for the most part, on the basis of private contributions and loans since it began operations in late 2004. CIRM did not respond to a question from the California Stem Cell Report about whether the failure to provide the loan has created any financial difficulties at the agency.
Welcome to The Biopolitical Times
The Center for Genetics and Society has entered the blogosphere with a site called The Biopolitical Times. Initial topics are heavily tilted to the current relationship between vote-crazed politicians and their attempts to exploit embryonic stem cell research.
An excerpt from an item by Marcy Darnovsky:
An excerpt from an item by Marcy Darnovsky:
"We’ve moved on from Fox and counter-Fox, wherein Rush Limbaugh demonstrates that “big idiot” is far too kind. Now we have top-level Democrats demonstrating their skill in cheap emotional blackmail. The take-home sentiment of a new ad by Majority Action, a Democratic 527, is that the Stem Cell Saviors will cure us all. And anyone who doubts that may as well have the blood of that sweet little six-year-old on their hands. This ad should be as embarrassing to those of us who support embryonic stem cell research as Limbaugh’s antics should be to its opponents."The center, which has actively tracked the California stem cell agency, is inviting comments, private or public, on the site.
Thursday, October 26, 2006
Stem Cell Snippets: Warehouses, Fox Ad and Pombo
Here links to some stories related to California stem cell issues:
UC Davis – A warehouse in Sacramento is being converted into a $75 million stem cell research center by UC Davis. Reporter Jim Downing of The Sacramento Bee wrote:
Pombo – Stem cell research rose to a higher level of visibility in a Central Valley congressional race in California. Reporter Lisa Vorderbrueggen of the Contra Costa Times wrote the story concerning incumbent Republican Richard Pombo and Democrat Jerry McNerney.
UC Davis – A warehouse in Sacramento is being converted into a $75 million stem cell research center by UC Davis. Reporter Jim Downing of The Sacramento Bee wrote:
"The new director of the Davis program, Jan Nolta, starts work Nov. 1. Nolta, who grew up in Willows, was recruited from Washington University in St. Louis along with longtime collaborator Gerhard Bauer, an Austrian native who is an an expert in the design and management of ultra-clean laboratories. Nolta and Bauer were at the UC Davis Medical Center on Wednesday as U.S. Rep. Doris Matsui, D-Sacramento, toured the laboratories of Mark Zern, an organ transplant expert whose research team is studying ways to use embryonic stem cells to regenerate the liver."Michael Fox – His stem cell TV ad rivals the nuclear destruction commercial in the 1964 presidential race in terms of free air time, according to one longtime observer at the Poynter Institute, a newspaper think tank.
Pombo – Stem cell research rose to a higher level of visibility in a Central Valley congressional race in California. Reporter Lisa Vorderbrueggen of the Contra Costa Times wrote the story concerning incumbent Republican Richard Pombo and Democrat Jerry McNerney.
Arlington Speaks on CIRM's Orphan Software
The head of the Arlington Group, the defunct grant review software firm used by the California stem cell agency, says that CIRM has not acquired the copyright or intellectual property rights to the program used by the agency and other major grant providers.
Earlier, we reported that the San Diego Union-Tribune quoted CIRM President Zach Hall as saying that the agency owned the computer codes involving the grant review program. (See item below.)
In response to an inquiry from the California Stem Cell Report, Mary Taylor, CEO and founder of Arlington, provided the following statement that we are carrying verbatim:
"CIRM acquired the rights to the Easygrants software source code to use, modify, or have modified for them for their business purposes.
"They did not acquire the intellectual property, distribution rights, copyright, etc. Second, Arlington Group delivered to CIRM all of the work that had been done to date on their system, including significant documentation of requirements for the system configuration, as well as the initial development work. With this in hand, when they begin working with the new development group, they can hit the ground running.
"Finally, with this transaction, CIRM is saving the state money on license fees for 2007 and forward. So while it was an unexpected challenge, worst of all for AG, CIRM has taken the steps needed to ensure their success and be good stewards of the state's money."
Why is all this important? Orphaned software can be a disaster. Often it is poorly documented internally, without explanations of how the code was constructed and works. When glitches occur, that makes it extremely difficult to maintain by the purchasers. That can mean that information is lost and cannot be compiled properly. Hopefully that is not the case here.
Earlier, we reported that the San Diego Union-Tribune quoted CIRM President Zach Hall as saying that the agency owned the computer codes involving the grant review program. (See item below.)
In response to an inquiry from the California Stem Cell Report, Mary Taylor, CEO and founder of Arlington, provided the following statement that we are carrying verbatim:
"CIRM acquired the rights to the Easygrants software source code to use, modify, or have modified for them for their business purposes.
"They did not acquire the intellectual property, distribution rights, copyright, etc. Second, Arlington Group delivered to CIRM all of the work that had been done to date on their system, including significant documentation of requirements for the system configuration, as well as the initial development work. With this in hand, when they begin working with the new development group, they can hit the ground running.
"Finally, with this transaction, CIRM is saving the state money on license fees for 2007 and forward. So while it was an unexpected challenge, worst of all for AG, CIRM has taken the steps needed to ensure their success and be good stewards of the state's money."
Why is all this important? Orphaned software can be a disaster. Often it is poorly documented internally, without explanations of how the code was constructed and works. When glitches occur, that makes it extremely difficult to maintain by the purchasers. That can mean that information is lost and cannot be compiled properly. Hopefully that is not the case here.
Wednesday, October 25, 2006
Death of CIRM Software Firm Only a 'Hiccup'
The California stem cell agency, which faces an enormous task in reviewing a flood of grant applications, is minimizing the impact of the demise of the company that produced the software for evaluating and coordinating the applications.
Reporter Terri Somers of the San Diego Union-Tribune wrote that the Arlington Group of McLean, Va., suddenly went "belly up," leaving CIRM in a digital lurch.
But, she also wrote, CIRM President Zach Hall said that CIRM now owns the computer codes behind the Arlington program. Somers continued:
Somers reported:
(Editor's note: A slightly earlier version of this item did not include the last two paragraphs.)
Reporter Terri Somers of the San Diego Union-Tribune wrote that the Arlington Group of McLean, Va., suddenly went "belly up," leaving CIRM in a digital lurch.
But, she also wrote, CIRM President Zach Hall said that CIRM now owns the computer codes behind the Arlington program. Somers continued:
"There was no warning that Arlington was about to go out of business, Hall said. Apparently an investor withdrew his money unexpectedly, causing the company to fold, he said.The original eight-year contract called for payment of $233,474 in the first year.
"Before that happened, the institute had paid $108,000 to Arlington, Hall said.
"The institute has since contracted with a new company, composed of former Arlington employees, to build the system at a cost equal to what it was to have paid the defunct company, Hall said."
Somers reported:
"'This has been a hiccup for us in terms of time schedule,' Hall said. 'But it's not a major issue.'"Dale Carlson, spokesman for CIRM, today told the California Stem Cell Report,
"We got the source code, which will be helpful to us going forward. We've got their senior developers ready to work with us. It isn't delaying the review of the grants. It isn't costing us any more money. And we're talking with Arlington's major customers about an ongoing network to support the platform."Those customers include the Bill & Melinda Gates Foundation, David and Lucile Packard Foundation and the Howard Hughes Medical Institute.
(Editor's note: A slightly earlier version of this item did not include the last two paragraphs.)
The $25 Million Bioethicists' Dog
The blog at the American Journal of Bioethics has addressed the issue of big money and "the butcher's avarice" in the stem cell wars being fought across the country in this fall's election.
Specifically Jim Fossett, director of health and Medicaid studies at the Rockefeller Institute, wrote on Oct. 21 about the Missouri tussle and noted how California led the way. He also had this to say:
Specifically Jim Fossett, director of health and Medicaid studies at the Rockefeller Institute, wrote on Oct. 21 about the Missouri tussle and noted how California led the way. He also had this to say:
"There are huge amounts of money at stake in the embryonic stem cell research debate, and much of the political and financial support for such initiatives is coming from parties that expect to get something out of them—large research grants, potentially lucrative patents and commercial opportunities, scientific prestige, political credit and campaign contributions, tax revenue and jobs. Bioethicists also have a dog in this fight — CIRM’s draft strategic plan earmarks $25 million to examine the social, ethical, etc. implications of stem cell research, and there have been complaints from some quarters that this isn’t enough. By the rules that govern politics and the markets, this is absolutely ok. The right to petition the government for a redress of grievances is enshrined in the Constitution, and capitalism relies on rewards to those who provide society with useful things. The desire for money and status is perfectly compatible with, and is frequently accompanied by, a deeply felt desire to do good and heal the sick. Those who find the scramble for money distasteful might usefully contemplate Adam Smith—'It is not by the butcher’s altruism, but by his avarice, that we may expect to receive our dinner.'"
Klein Helps Aussies in Stem Cell Fray
California stem cell Chairman Robert Klein recently sang a stem cell tune that was "music" to some Australian ears. So says reporter Leigh Dayton in a story in The Australian.
Australia is caught up in a bit of controversy over stem cell research, and Klein visited there to support the forces of embryonic stem cell research.
Dayton wrote:
Dayton reported:
Australia is caught up in a bit of controversy over stem cell research, and Klein visited there to support the forces of embryonic stem cell research.
Dayton wrote:
"'Mr Klein generously offered to visit Australia to help us in the current legislative climate," (Stephen) Livesey (CEO of the Australian Stem Cell Center) says. 'He provided the Australian stem cell science community with advice on how to engage the public, patients and politicians on the complex topic of stem cell research.'"Klein's stem cell drum beating had a familiar sound to those who have heard him speak in California, but wa swelcomed down under.
Dayton reported:
"Clearly, Klein's words are music to the ears of Australian scientists and patient advocacy groups pushing to change the nation's embryo research and anti-cloning legislation."The Australian account said Klein was "a guest" of the Australian Stem Cell Center last week, but did not specifically make clear who funded his trip. CIRM says it did not pay for his trip.
Stem Cell Snippets: Conflicts, WARF and Politics
Here are links to items of interest related to California stem cell matters.
Conflicts of Interest – Maryland is wrestling with the same conflict-of-interest questions that dog the California stem cell agency. Erin Bryant of Capital News Service wrote that legislation creating the Maryland stem commission built in the conflicts and does not spell out whether commission members are allowed to vote on applications from their own institutions. One member of the group thinks they should.
WARF – Longtime WARF stalwart Beth Donley is leaving that organization. Donley, the foundation's general counsel, had worked for the organization for eight years. Only six weeks ago she too control of its WiCell affiliate. Donley said she wants to move on to the "next level" – the private sector. That could be translated as higher compensation. It does seem odd that she is leaving so soon after her appointment to the WiCell position. Here is a link to Joe Vanden Plas' story on the Wisconsin Technology Network.
NEJM – The New England Journal of Medicine has a couple of pieces on the politics of stem cells and the flap over the ACT stem cell extraction announcement. Nothing new in the ACT item, but it is a straight-forward delineation of what occurred as compared to the somewhat muddled accounts elsewhere. Likewise with the politics piece.
Conflicts of Interest – Maryland is wrestling with the same conflict-of-interest questions that dog the California stem cell agency. Erin Bryant of Capital News Service wrote that legislation creating the Maryland stem commission built in the conflicts and does not spell out whether commission members are allowed to vote on applications from their own institutions. One member of the group thinks they should.
WARF – Longtime WARF stalwart Beth Donley is leaving that organization. Donley, the foundation's general counsel, had worked for the organization for eight years. Only six weeks ago she too control of its WiCell affiliate. Donley said she wants to move on to the "next level" – the private sector. That could be translated as higher compensation. It does seem odd that she is leaving so soon after her appointment to the WiCell position. Here is a link to Joe Vanden Plas' story on the Wisconsin Technology Network.
NEJM – The New England Journal of Medicine has a couple of pieces on the politics of stem cells and the flap over the ACT stem cell extraction announcement. Nothing new in the ACT item, but it is a straight-forward delineation of what occurred as compared to the somewhat muddled accounts elsewhere. Likewise with the politics piece.
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