The following comes to you live from The Stem Cell Meeting in San Francisco.
At the end of the day came rhetoric about the culture of death, bald eagles and their eggs and how we all should be able to get along.
The last meeting of The Stem Cell Meeting in San Francisco concluded with a lively panel on ethics in stem cell research. It was heated at times, humorous and informative. But it did not change the mind of a single person (we think).
Following the final panel, the host of the conference, Steve Burrill, head of the firm bearing his name, told the audience the two-day conference was planned to avoid an event where business people talk only to business people and scientists only talk to scientists. And that it was, an interesting cross section of bureaucrats, executives, scientists, religious folks and so forth. Burrill promised another session the same time next year.
We will have more tomorrow on the events at the meeting.
Tuesday, March 14, 2006
Wisconsin to CIRM: Cough Up Some Cash
The following is coming live from The Stem Cell Meeting today in San Francisco, sponsored by Burrill and Co.
Wisconsin wants a piece of the California stem cell pie.
That's because the California stem cell agency has decided to give its own state 25 percent royalties on any inventions created with CIRM-funded embryonic stem cell research.
Wisconsin is involved because the Wisconsin Alumni Research Foundation has two patents that broadly cover the preparation of embryonic stem cells. Beth Donley, general counsel, Wisconsin Alumni Research Foundation, said that if CIRM stipulates 25 percent royalties for California that requirement amounts to commercialization. And that means WARF wants a payment from California.
How much would that amount to? Speaking during a panel session at The Stem Cell Meeting in San Francisco today, Donley said that licenses start at fairly low rates and mentioned a bottom figure of $75,000. In February of 2005, Peter Balbus, managing director at Pragmaxis LLC, of Glen Ellyn, Ill., estimated that Wisconsin could receive $200 million for $4 billion in stem cell product revenues. However, it is not clear whether that estimate is still valid.
Donley told industry representatives at the conference, sponsored by Burrill & Co., that she had spoken with CIRM officials on three occasions. The last time was on Monday when she told Robert Klein, California stem cell chairman, that the 25 percent royalty provision meant that CIRM was "trading on (Wisconsin) technology to build a (commercial) program." She said CIRM could provide the royalty in various ways. One would be to provide a stream of revenue from whatever California receives. Another would be to build it into grant arrangements with the nonprofit institutions.
Todd Lorenz, chair, Life Sciences and Health Care, Dorsey & Whitney LLP, another member of the panel, said Donley's statement raised the issue of "suffocation of product." The term refers to excessive layers of royalties of as much of 25 to 30 percent that stifle commercialization of therapies. Donley said Wisconsin was entitled to receive payments for use of its products and that the funds would go for research and education.
Wisconsin wants a piece of the California stem cell pie.
That's because the California stem cell agency has decided to give its own state 25 percent royalties on any inventions created with CIRM-funded embryonic stem cell research.
Wisconsin is involved because the Wisconsin Alumni Research Foundation has two patents that broadly cover the preparation of embryonic stem cells. Beth Donley, general counsel, Wisconsin Alumni Research Foundation, said that if CIRM stipulates 25 percent royalties for California that requirement amounts to commercialization. And that means WARF wants a payment from California.
How much would that amount to? Speaking during a panel session at The Stem Cell Meeting in San Francisco today, Donley said that licenses start at fairly low rates and mentioned a bottom figure of $75,000. In February of 2005, Peter Balbus, managing director at Pragmaxis LLC, of Glen Ellyn, Ill., estimated that Wisconsin could receive $200 million for $4 billion in stem cell product revenues. However, it is not clear whether that estimate is still valid.
Donley told industry representatives at the conference, sponsored by Burrill & Co., that she had spoken with CIRM officials on three occasions. The last time was on Monday when she told Robert Klein, California stem cell chairman, that the 25 percent royalty provision meant that CIRM was "trading on (Wisconsin) technology to build a (commercial) program." She said CIRM could provide the royalty in various ways. One would be to provide a stream of revenue from whatever California receives. Another would be to build it into grant arrangements with the nonprofit institutions.
Todd Lorenz, chair, Life Sciences and Health Care, Dorsey & Whitney LLP, another member of the panel, said Donley's statement raised the issue of "suffocation of product." The term refers to excessive layers of royalties of as much of 25 to 30 percent that stifle commercialization of therapies. Donley said Wisconsin was entitled to receive payments for use of its products and that the funds would go for research and education.
Warnings about Overhyping Stem Cell Science
The following is coming live from The Stem Cell Meeting today in San Francisco, sponsored by Burrill and Co.
California stem cell chairman Robert Klein is heading a panel called "Stem Cell Politics: Global Strategies for Supporting Research." Michael Werner of The Werner Group has just told the audience that no state in this country is "talking about the kind of money" that is likely to be available in California. The best prospects for significant stem cell research funding are in New Jersey, Maryland and Illinois. Angela McNab, chief executive of the Human Fertilization and Embryology Authority in the UK, warned that the audience that they cannot take public confidence in stem cell research for granted. She said excessive enthusiasm can lead to overhyping benefits and the speed with which they will be produced. She warned that when results are not forthcoming, opponents "will use the hype to discredit the science."
We will have more on the conference later today.
California stem cell chairman Robert Klein is heading a panel called "Stem Cell Politics: Global Strategies for Supporting Research." Michael Werner of The Werner Group has just told the audience that no state in this country is "talking about the kind of money" that is likely to be available in California. The best prospects for significant stem cell research funding are in New Jersey, Maryland and Illinois. Angela McNab, chief executive of the Human Fertilization and Embryology Authority in the UK, warned that the audience that they cannot take public confidence in stem cell research for granted. She said excessive enthusiasm can lead to overhyping benefits and the speed with which they will be produced. She warned that when results are not forthcoming, opponents "will use the hype to discredit the science."
We will have more on the conference later today.
Coming Up
Today we are attending The Stem Cell Meeting in San Francisco sponsored by Burrill and Co. The conference will be discussing the investment environment for stem cell research along with ethical issues, among other things. Topics include "Where is The Money" and "The Business of Stem Cells." We hope to post items from the conference as it occurs, if the opportunity is available. If not, we will post news from the conference this evening (Pacific Standard Time).
No Teleconferencing for Research Working Group Meeting
Earlier this month we reported that some sort of teleconferencing arrangements were in the works for today's meeting of the research working group of the California agency. However, the reference to those arrangements has been stripped from the agenda posted on the Web. We queried the agency about the matter. They responded that teleconferencing is available only for members of the working groups – not the public.
Monday, March 13, 2006
The New, Obscure Run at California Stem Cell Research Guidelines
Belatedly and quietly, another California state agency is looking into ethical standards for embryonic stem cell research. And at its first meeting two members suggested that it might be appropriate to pay women for donating eggs.
The agency in question is the Department of Health Services. Under 2003 legislation by California state Sen. Deborah Ortiz, chair of the Senate Committee, the department was required to develop guidelines for embryonic stem cell research by Jan. 1, 2005, with the use of an advisory committee.
That 13-member committee was not appointed until six months after that deadline. It did not hold its first meeting until Feb. 24 of this year with the only public notice coming on an obscure website within the Department of Health Services.
Lea Brooks, chief of the public information section of DHS, said the department has no plans to notify the public about committee meetings other than by postings on the website, even if individuals request notification. The committee is expected to have two more meetings before concluding its work this fall.
The committee's guidelines affect all embryonic stem cell research in California, except for that financed by the California stem cell agency, which already has approved its own rules. CIRM is constitutionally independent of DHS and and is not required to adhere to the DHS guidelines.
Members of the advisory committee, however, seem to be in agreement on creating guidelines that are consistent with CIRM regulations, based on a somewhat garbled transcript of the Feb. 24 meeting, which was not covered by the media.
However, the ticklish issue of payments for eggs, which CIRM has shied away from, was raised by committee member Elliott Dorff, a professor of philosophy, who, according to the transcript, said:,
"One issue is just simply how realistic it is to expect women to donate their eggs free of charge. That the UCLA Bruins -- I can’t say the law school at UCLA -- every single time, there are ads for women to donate their eggs for purposes of fertilizing other couples. And while the standard used to be $5,000 plus expenses, I’ve seen ads as high as $80,000 for a particular kind of egg. And so one issue that - I mean I understand why the guidelines don’t want to have any exchange over this, but if the case, I’m sort of wondering whether is it at all realistic."
Committee member Gregory Stock also expressed concerned about a ban on remuneration.
The delay in implementation of the guideline law is a matter of some dispute. Questions have also been raised about reported changes in the committee's composition.
Brooks said the law, as originally passed, did not provide funding. However, other sources indicated that the governor attempted to "defund" it in his first budget. Brooks said it took from June 7, 2005, the date of the committee's appointment, until recently to get all members of the committee to agree to serve and to agree on a meeting date.
Another source said one list of committee members was circulated but that it was changed without notifying persons who were on the original list. The implication was that the committee was altered to be less restrictive on research. Brooks said there was only one list.
It is not clear how much privately funded embryonic stem cell research is underway in California. However, Stanford and UC San Francisco both have private grants to build facilities to do privately funded research. The state also has a number of privately funded stem cell companies.
The bulk of the first advisory committee meeting was largely occupied with background briefings and organizational issues, based on the transcript.
The next public meeting may come in May or June with the final session later this year, according to Henry Greely, chairman of the panel. During the interim, subcommittees will work privately to prepare material for the full committee meetings.
Here is the official list of the committee members: Elizabeth Helen Blackburn, Ph.D, Professor, Departments of Biochemistry and Biophysics, University of California, San Francisco; Samuel H. Cheshier, M.D., Ph.D. Neurosurgical Resident, Department of Neurosurgery, Stanford University School of Medicine; Gregory Stock, Ph.D., M.B.A., Director, Program on Medicine, Technology and Society, University of California, Los Angeles; Irving Weissman, M.D.Director and Professor, Institute of Cancer/Stem Cell Biology and Medicine, Division of Neurosurgery, Department of Medicine, Stanford University School of Medicine; Otoniel Martinez-Masa, Ph.D. Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine, University of California, Los Angeles; Fred Gage, Ph.D. Laboratory of Genetics, The Stalk Institute for Biological Studies; Bertram H. Lubin, M.D. President, Children’s Hospital Oakland Research Institute and Director of Cord Blood Program; Bernard Lo, M.D. Director of Program in Medical Ethics, Professor of Medicine, University of California, San Francisco; David Magnus, Ph.D. Director, Stanford Center for Biomedical Ethics and Associate Professor, Department of Pediatrics, Stanford University; Henry Greely, J.D. Professor of Law, Stanford Law School; Radhika Rao, J.D. Professor of Law, University of California, Hastings College of Law, San Francisco; Elliot Dorff, Ph.D. Professor of Philosophy, University of Judaism, Los Angeles; Margaret R. McLean, Ph.D. Assistant Director, Markkula Center for Applied Ethics and Director, Biotechnology and Heath Care Ethics, Santa Clara University.
More information on the committee can be found at this website.
The agency in question is the Department of Health Services. Under 2003 legislation by California state Sen. Deborah Ortiz, chair of the Senate Committee, the department was required to develop guidelines for embryonic stem cell research by Jan. 1, 2005, with the use of an advisory committee.
That 13-member committee was not appointed until six months after that deadline. It did not hold its first meeting until Feb. 24 of this year with the only public notice coming on an obscure website within the Department of Health Services.
Lea Brooks, chief of the public information section of DHS, said the department has no plans to notify the public about committee meetings other than by postings on the website, even if individuals request notification. The committee is expected to have two more meetings before concluding its work this fall.
The committee's guidelines affect all embryonic stem cell research in California, except for that financed by the California stem cell agency, which already has approved its own rules. CIRM is constitutionally independent of DHS and and is not required to adhere to the DHS guidelines.
Members of the advisory committee, however, seem to be in agreement on creating guidelines that are consistent with CIRM regulations, based on a somewhat garbled transcript of the Feb. 24 meeting, which was not covered by the media.
However, the ticklish issue of payments for eggs, which CIRM has shied away from, was raised by committee member Elliott Dorff, a professor of philosophy, who, according to the transcript, said:,
"One issue is just simply how realistic it is to expect women to donate their eggs free of charge. That the UCLA Bruins -- I can’t say the law school at UCLA -- every single time, there are ads for women to donate their eggs for purposes of fertilizing other couples. And while the standard used to be $5,000 plus expenses, I’ve seen ads as high as $80,000 for a particular kind of egg. And so one issue that - I mean I understand why the guidelines don’t want to have any exchange over this, but if the case, I’m sort of wondering whether is it at all realistic."
Committee member Gregory Stock also expressed concerned about a ban on remuneration.
The delay in implementation of the guideline law is a matter of some dispute. Questions have also been raised about reported changes in the committee's composition.
Brooks said the law, as originally passed, did not provide funding. However, other sources indicated that the governor attempted to "defund" it in his first budget. Brooks said it took from June 7, 2005, the date of the committee's appointment, until recently to get all members of the committee to agree to serve and to agree on a meeting date.
Another source said one list of committee members was circulated but that it was changed without notifying persons who were on the original list. The implication was that the committee was altered to be less restrictive on research. Brooks said there was only one list.
It is not clear how much privately funded embryonic stem cell research is underway in California. However, Stanford and UC San Francisco both have private grants to build facilities to do privately funded research. The state also has a number of privately funded stem cell companies.
The bulk of the first advisory committee meeting was largely occupied with background briefings and organizational issues, based on the transcript.
The next public meeting may come in May or June with the final session later this year, according to Henry Greely, chairman of the panel. During the interim, subcommittees will work privately to prepare material for the full committee meetings.
Here is the official list of the committee members: Elizabeth Helen Blackburn, Ph.D, Professor, Departments of Biochemistry and Biophysics, University of California, San Francisco; Samuel H. Cheshier, M.D., Ph.D. Neurosurgical Resident, Department of Neurosurgery, Stanford University School of Medicine; Gregory Stock, Ph.D., M.B.A., Director, Program on Medicine, Technology and Society, University of California, Los Angeles; Irving Weissman, M.D.Director and Professor, Institute of Cancer/Stem Cell Biology and Medicine, Division of Neurosurgery, Department of Medicine, Stanford University School of Medicine; Otoniel Martinez-Masa, Ph.D. Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine, University of California, Los Angeles; Fred Gage, Ph.D. Laboratory of Genetics, The Stalk Institute for Biological Studies; Bertram H. Lubin, M.D. President, Children’s Hospital Oakland Research Institute and Director of Cord Blood Program; Bernard Lo, M.D. Director of Program in Medical Ethics, Professor of Medicine, University of California, San Francisco; David Magnus, Ph.D. Director, Stanford Center for Biomedical Ethics and Associate Professor, Department of Pediatrics, Stanford University; Henry Greely, J.D. Professor of Law, Stanford Law School; Radhika Rao, J.D. Professor of Law, University of California, Hastings College of Law, San Francisco; Elliot Dorff, Ph.D. Professor of Philosophy, University of Judaism, Los Angeles; Margaret R. McLean, Ph.D. Assistant Director, Markkula Center for Applied Ethics and Director, Biotechnology and Heath Care Ethics, Santa Clara University.
More information on the committee can be found at this website.
Coming Up
A little later today we will look at the other California state agency that deals with stem cell research issues. Obscure and dilatory seem to be its hallmarks, although its actions could be far-reaching.
The California Stem Cell Trial: 'Purely Political'
If you missed the piece by the UCLA law professor arguing that the California stem cell trial was a waste of valuable court time, you might want to check out a version of it that appeared this morning in the San Francisco Chronicle.
The article was written by Russell Korobkin. He said, among other things:
The article was written by Russell Korobkin. He said, among other things:
"So far, the judicial system has been complicit in the use of the courts for purely political purposes. Because the lawsuit clearly lacked legal merit, the case could have, and should have, been thrown out months ago. Instead, an overly cautious Alameda County Superior Court judge told the plaintiffs that, although she found their written arguments unconvincing, she would afford them another opportunity to convince her by presenting evidence at trial."
Friday, March 10, 2006
Penultimate Clashes in the Stem Trial
The almost final arguments in the California stem cell trial have now been filed. Rebuttals are due next week.
Here is part of what reporter Bernadette Tansey of the San Francisco Chronicle had to say about the filings:
Here is part of what reporter Bernadette Tansey of the San Francisco Chronicle had to say about the filings:
"Robert Taylor, an attorney for the taxpayer group People's Advocate, argued that members of the independent committee charged with distributing billions in stem cell grants represent the interests of the universities and disease advocacy organizations from which they are drawn, not the interests of the state at large. But the state prosecutor defending the stem cell initiative said the challengers had failed to produce any evidence at trial to prove their claims. The testimony demonstrated that the new research institute is subject to supervision and control by state authorities including the treasurer's office and the Legislature, wrote Deputy Attorney General Tamar Pachter...."It appears that Tansey was the only reporter to file a story this morning on the filings, but, of course, that statement has to be qualified by proficiency of the usual search engines, which do not find everything.
"The opponents will have a last chance to counter each other's written arguments Wednesday, when final reply briefs must be filed with Alameda County Superior Court Judge Bonnie Sabraw. She will then issue a written ruling, possibly within weeks. But even if the plaintiffs lose, their appeals could take another year."
Thursday, March 09, 2006
Four Stem Cell Biggies Form Consortium
San Diego is on a stem cell roll this week. First it was the public embryo bank – the nation's first ever. Now it is a plan to become the world's epicenter of stem cell research.
Reporter Terri Somers broke both of the stories in the San Diego Union-Tribune. Her piece today said that "four La Jolla research institutes plan to join forces and seek state funding to build a facility for human embryonic stem cell research."
They are the University of California, San Diego, and the Burnham, Scripps and Salk institutes. The site would be on the UC campus, which is close to the other three organizations. Somers said their agreement would create a nonprofit entity to plan and build the embryonic stem cell research facility. They would also pledge not to individually seek grants from CIRM.
Somers said, "A new building is important because federal limitations on stem cell research make it impossible to do much of the work in labs that receive federal funding."
Part of the consortium's strategy is to create a better chance of receiving grants, Somers wrote.
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For those of you outside of California, Jolla is pronounced hoy-yah. It is derived from the Spanish word "joya," which means jewel. There is a pun in there someplace about stem cell jewels and crowning consortiums, but we are not going to look for it.
Reporter Terri Somers broke both of the stories in the San Diego Union-Tribune. Her piece today said that "four La Jolla research institutes plan to join forces and seek state funding to build a facility for human embryonic stem cell research."
They are the University of California, San Diego, and the Burnham, Scripps and Salk institutes. The site would be on the UC campus, which is close to the other three organizations. Somers said their agreement would create a nonprofit entity to plan and build the embryonic stem cell research facility. They would also pledge not to individually seek grants from CIRM.
Somers said, "A new building is important because federal limitations on stem cell research make it impossible to do much of the work in labs that receive federal funding."
Part of the consortium's strategy is to create a better chance of receiving grants, Somers wrote.
"'Individually all of the consortium institutes are stellar, but together we will be a tour de force and become the epicenter of stem cell research in the United States, and therefore the world,' said Dr. Edward Holmes, UCSD vice chancellor of health sciences."Holmes, John Reed, president of Burnham, and Richard Murphy, president of Salk, are all on CIRM's 29-member Oversight Committee.
"In that role, they vote on who they think should receive research grants; however, the three would not be allowed to vote on grant requests from the consortium," Somers reported.Zach Hall, president of CIRM, praised creation of the consortium, saying CIRM istrying to encourage the pooling of resources.
"Hall, a former vice chancellor at UC San Francisco, helped draft a plan for creating four distinct research institutes within the University of California.One of the players credited with pushing the effort during the last year is John Moores, who owns the San Diego Padres baseball team and is on the UC Board of Regents and the Scripps board. Reed said Moores was an important catalyst in pushing discussions forward.
"'They were all within the University of California and it was still difficult because each has different cultures, different personalities and different rules,' Hall said. 'The fact that these four institutions have put this together I think is a wonderful signal. I'm tremendously impressed with the effort that must have gone into this.'"
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For those of you outside of California, Jolla is pronounced hoy-yah. It is derived from the Spanish word "joya," which means jewel. There is a pun in there someplace about stem cell jewels and crowning consortiums, but we are not going to look for it.
Los Angeles Readers Told of Stem Cell 'Silliness'
LA Weekly, a 207,000-circulation alternative newspaper, has offered up its status report on the California stem cell agency in a piece headlined "The Stem Cell Debate Gets Silly."
Regular readers of this blog are not likely to find new information in the article by Steven Kotler. However, it does quote us on the subject of the stem cell trial, which obviously makes the piece worth checking out. It also quotes bioethicist Alta Charo as saying the stem cell debate is still "about everything but stem cells."
Kotler also wrote good-reading piece in 2003 on the state of stem cell research, which still retains freshness. A sample:
Regular readers of this blog are not likely to find new information in the article by Steven Kotler. However, it does quote us on the subject of the stem cell trial, which obviously makes the piece worth checking out. It also quotes bioethicist Alta Charo as saying the stem cell debate is still "about everything but stem cells."
Kotler also wrote good-reading piece in 2003 on the state of stem cell research, which still retains freshness. A sample:
"Irv Weissman doesn’t look the bear-eating sort. He’s of middle height, middle weight, mildly balding, with fine clothes, a jovial aspect and a long, wispy beard. He looks like a Russian poet or an aged food critic. But, beneath this exterior, he’s just a boy from Montana. Which is to say he comes from a culture of bear eaters."Kotler's website makes it difficult to provide a direct link to the story, but you can find it under "articles" Jan. 1, 2003.
Wednesday, March 08, 2006
CIRM Faces State Performance Audit
The California stem cell agency is facing a new and tougher official examination of its performance.
That is the result of approval of a request by Sen. Deborah Ortiz and 10 other legislators for a review of CIRM by the California auditor general. The audit should be significantly more rigorous than the ones authorized by state law involving the state controller's office.
Ortiz' office released the following statement:
That is the result of approval of a request by Sen. Deborah Ortiz and 10 other legislators for a review of CIRM by the California auditor general. The audit should be significantly more rigorous than the ones authorized by state law involving the state controller's office.
Ortiz' office released the following statement:
"In presenting the audit request, Sen. Ortiz said the audit will review the administrative expenditures as well as the policies and procedures to ensure they are consistent with the intent of the initiative and with best practices for research organizations and public agencies – critical steps to ensure that up to $7 billion in public money is being spent appropriately.The legislature's joint audit committee approved the audit today by a 9-0 vote. Reporter Steve Johnson of the San Jose Mercury News wrote a story on the decision. You can read it here.
"'I believe the audit will help ensure that the program is on sound footing as it moves into its grant-making phase next year,' she said.
"In her testimony, Sen. Ortiz noted CIRM and ICOC will have spent close to $8 million in administrative funds by the end of the year and approved $40 million in training grants in September 2005, which they hope to finance through loans from philanthropic organizations since the public bonds authorized by voters in approving Proposition 71 are held up by litigation.
"As some of you know, the program has stumbled in its first year of existence,' Ortiz said. 'It has struggled with implementation of open meeting procedures as well as policies to guard against conflicts of interest on the part of its working group members. In addition, it has issued contracts for some questionable things, including a $27,000 per month contract for public relations work, a $300,000 contract for private legal counsel and a $10,000 per month contract for lobbying.'
"State Auditor Elaine M. Howle said the audit would evaluate the CIRM’s and ICOC’s strategic plans, including determining whether they are clearly defined. Her office also will determine whether CIRM and ICOC are properly identifying and avoiding conflicts of interest, establishing realistic timetables realistic, have in place effective management controls to ensure they are complying with state laws and whether they are protecting the state’s interest. She said her office also would evaluate the development of policies and procedures, including contracting for facilities, hiring practices and the procurement of goods and services.
"Howle estimated the length of the audit will be six months. She did not say when the audit would begin."
CIRM: Remarkable But a State Budgetary Wisp
The budgets proposed by the governors of California in January are always a bit of wishful thinking. They are projections for proposed spending by the state of California for the fiscal year beginning in July. They are usually revised significantly in May.
Nonetheless, it is useful to consider how the state currently regards the California stem cell agency in terms of its budget. The governor's budget places CIRM in category 6445, under higher education, along with the University of California and the California State University system. The governor's budget states that spending by CIRM will run at about $309 million during the next fiscal year, which means that it assumes that court challenges to CIRM will fail. Keep in mind that the budget reflects figures provided by the agencies.
A month or so after the governor proposes his budget comes the legislative analyst's report, dissecting the spending plan agency by agency. In California, the legislative analyst is generally considered the most authoritative source on state fiscal matters.
So what does that legislative analyst think about the CIRM budget? It doesn't. The budget item, 6445, is not included in the analyst's report. Why is that, we asked the head of the higher education unit in legislative analyst office, Steve D. Boilard? Here is his response verbatim:
"It was intentionally omitted. In the short time we have to review the budget proposal, we just focus on major issues. The Gov's budget proposes to spend about $300 million in bond funds ($276 million of which would be provided for research grants) to carry out Prop 71. Of course, the fact the actual selling of bonds is tied up in the courts casts some doubt on whether this will in fact happen."
Boilard is correct. CIRM is not a major issue for the legislative analyst's office. But it goes beyond that. CIRM's budget is not subject to approval by the California legislature or the governor. Even the State Supreme Court must have its $42 million-a-year budget approved by the legislature. But CIRM does not, which, of course, makes it one of the most remarkable agencies in California history and one of the reasons we write about it in this blog.
Nonetheless, it is useful to consider how the state currently regards the California stem cell agency in terms of its budget. The governor's budget places CIRM in category 6445, under higher education, along with the University of California and the California State University system. The governor's budget states that spending by CIRM will run at about $309 million during the next fiscal year, which means that it assumes that court challenges to CIRM will fail. Keep in mind that the budget reflects figures provided by the agencies.
A month or so after the governor proposes his budget comes the legislative analyst's report, dissecting the spending plan agency by agency. In California, the legislative analyst is generally considered the most authoritative source on state fiscal matters.
So what does that legislative analyst think about the CIRM budget? It doesn't. The budget item, 6445, is not included in the analyst's report. Why is that, we asked the head of the higher education unit in legislative analyst office, Steve D. Boilard? Here is his response verbatim:
"It was intentionally omitted. In the short time we have to review the budget proposal, we just focus on major issues. The Gov's budget proposes to spend about $300 million in bond funds ($276 million of which would be provided for research grants) to carry out Prop 71. Of course, the fact the actual selling of bonds is tied up in the courts casts some doubt on whether this will in fact happen."
Boilard is correct. CIRM is not a major issue for the legislative analyst's office. But it goes beyond that. CIRM's budget is not subject to approval by the California legislature or the governor. Even the State Supreme Court must have its $42 million-a-year budget approved by the legislature. But CIRM does not, which, of course, makes it one of the most remarkable agencies in California history and one of the reasons we write about it in this blog.
Tuesday, March 07, 2006
CIRM Makes "Progress" Says Monitor
Jeanne Loring, co-director of the stem cell center at the Burnham Institute in La Jolla, reports that her staff is taking pay cuts to keep grad students and post doctoral clinicians on payroll until the money starts flowing from the California stem cell agency.
So said writer Daniel Wood of the Christian Science Monitor in a piece on the agency and its current state of affairs. Known as a "situationer," the article said,
The other comment: CIRM continues to assert that because it has held something in the neighborhood of 60 meetings, that means it is moving forward. And reporters, constrained by media obligations to report even the weakest of assertions, repeat the claim. We all know that what counts, at least in business terms, is product sold, contracts signed and money in the bank. So far, CIRM still is living on the dole and has not funded a grant. Purchasers of bond anticipation notes are not going to be fooled by a tally of meetings as a measure of progress. The agency has other, better benchmarks. CIRM should drop the feeble claim. Perhaps they could schedule a meeting to officially retire the assertion.
So said writer Daniel Wood of the Christian Science Monitor in a piece on the agency and its current state of affairs. Known as a "situationer," the article said,
"By most accounts, the CIRM has made significant progress on practically every front. It has filled out its governing board with some of the top scientists in the country and has held over five dozen public meetings to air concerns."The article, which also appeared in USA Today, was generally favorable. Wood reported,
"'The CIRM has been subjected to an extraordinary amount of attention from public, press, and legislators and has responded with extraordinary openness through the past year,' says R. Alta Charo, a law and bioethics professor at the University of Wisconsin in Madison."A couple of comments: Perhaps the attention seems "extraordinary" to Charo, but the reality is that it has amounted to only a minor blip. The attention CIRM has received has been higher than that given to the creation of the department created by Prop. 65 a few years ago in California. But Prop. 65 did not carry a $6 billion price tag. Extraordinary attention is what the gubernatorial recall election received in 2003.
The other comment: CIRM continues to assert that because it has held something in the neighborhood of 60 meetings, that means it is moving forward. And reporters, constrained by media obligations to report even the weakest of assertions, repeat the claim. We all know that what counts, at least in business terms, is product sold, contracts signed and money in the bank. So far, CIRM still is living on the dole and has not funded a grant. Purchasers of bond anticipation notes are not going to be fooled by a tally of meetings as a measure of progress. The agency has other, better benchmarks. CIRM should drop the feeble claim. Perhaps they could schedule a meeting to officially retire the assertion.
Public Embryo Bank Started at Secret San Diego Location
A secret location in San Diego houses what is believed to be nation's first public embryo bank, which seeks to tap into the more than 400,000 human embryos frozen at in vitro fertilization clinics around the country, the San Diego Union-Tribune reported this morning.
Reporter Terri Somers wrote the story, which said that scientists are gathering the leftover embryos with plans to "send them to stem cell researchers around the globe."
The embryo bank is called the Stem Cell Resource. Somers said it was "created by a local in vitro fertilization doctor, two scientists from the Burnham Institute for Medical Research and a fourth person whom the others declined to identify." The location is being kept secret for security reasons.
Reporter Terri Somers wrote the story, which said that scientists are gathering the leftover embryos with plans to "send them to stem cell researchers around the globe."
The embryo bank is called the Stem Cell Resource. Somers said it was "created by a local in vitro fertilization doctor, two scientists from the Burnham Institute for Medical Research and a fourth person whom the others declined to identify." The location is being kept secret for security reasons.
"The impetus behind the bank's creation was a combination of a shortage of embryonic stem cells for research purposes and the desires of women to do something with embryos that they said would never have a chance of life," Somers reported.Somers continued:
"'Until now, patients who decided that they wanted to donate their embryos to research had no place to send them,' said (one) of the bank's founders, Dr. David Smotrich, who founded his own practice, La Jolla IVF, six years ago."
"'We've already been contacted by scientists in Israel, and we've talked to people at Harvard and elsewhere around the country,' said Jeanne Loring, one of the founding scientists."
"A few in vitro clinics have had agreements to supply embryos to researchers. Advanced Cell Technologies, a biotechnology company started in Massachusetts to conduct stem cell research, has had agreements with a few different doctors, Chief Executive William Caldwell said.Somers wrote:
"But Caldwell, (Pamela)Madsen (founder of the American Fertility Association) and others contacted for this story believe the Stem Cell Resource might be the first embryo bank of its kind, making collections from various doctors and screening who will receive them.
"Mindful of the federal funding crunch, the Stem Cell Resource plans to make the embryos available to vetted researchers at no cost, said Loring, an embryologist with the Burnham Institute and one of the bank's founders. Dr. Evan Snyder, a pediatrician and stem cell researcher at the Burnham Institute, is also a founder."
"Smotrich used his own money – about $100,000 so far – to fund the startup of the embryo bank. He has been reimbursed in part by private funds through the Burnham Institute. And he hopes that the facility will eventually be eligible for grants from the California Institute of Regenerative Medicine, which was created by Proposition 71.
"Everyone who works at the Resource does so without pay, including Smotrich, several Burnham scientists and an embryologist who performs the in vitro fertilization work for Smotrich's practice."
Monday, March 06, 2006
The Stem Cell Trial: A View From an Advocate
For a view of the California stem cell trial from the very personal perspective of a Prop. 71 supporter and tireless advocate, take a look at some of the Web postings by Don C. Reed.
We have mentioned Reed previously. He is an amiable fellow and easy to underestimate.
He attends CIRM meetings religiously and was present at each day of the trial last week. Here is a sample from one of his postings about the trial on his web site, stemcellbattles.com.
You can see more of Reed's commentary by going to his archives.
We have mentioned Reed previously. He is an amiable fellow and easy to underestimate.
He attends CIRM meetings religiously and was present at each day of the trial last week. Here is a sample from one of his postings about the trial on his web site, stemcellbattles.com.
"Describing the Judge herself is difficult, without sounding like I am kissing up.Reed also wrote about a two-day conference last week at UC Berkeley on stem cell issues that went totally unreported elsewhere, if you are to believe Google searches.
"But anyone wanting to know how to maintain control while still allowing everyone their dignity, should visit the courtroom of Judge Sabraw.
"Once when an attorney thrust his arm almost violently into the air, so eager to be heard, the Judge smiled and said, “I see that ___________ is champing at the bit.” Her tone was polite, but she immediately softened it anyway, saying, “But I do not wish to make light of it; what would you like to say?”
"Before deciding on any point, even the smallest procedural matter, she would check both sides repeatedly, allowing argument until every slightest nuance was explored.
"Just once a lawyer argued a little bit too long—after her decision had been made.
"She interrupted him.
"'That objection was overruled," she said.
"She spoke ever so softly, and she smiled, but there was just the faintest tinge of frost in the air.
"It was suddenly quiet in the room, and the attorney did not find it necessary to comment any further on the matter."
You can see more of Reed's commentary by going to his archives.
Sunday, March 05, 2006
IP Policy for Business Upcoming Along With Grants Rules
The California stem cell agency is busy laying the ground work for some tough work on intellectual property policies involving grants to biotech businesses and research firms.
This is likely to be more difficult than development of the policies on IP for non-profit institutions, which were approved last month. Money, of course, is the key: How to provide sufficient profit motive to stimulate development of therapies.
Patient advocates on the Oversight Committee have already indicated that they are likely to favor policies that will speed treatments. Watchdogs of the public purse are likely to be less generous with the results of state-funded research.
We are also likely to see more comments from the biotech industry. Look for the first public hearings on this issue late this month. Development of a complete policy is likely to take some months. If you want to weigh in with comments prior to the first hearing, you can contact the agency via its web site.
While the IP policy gets underway, Zach Hall, president of CIRM, says his top priority right now is fund-raising for two, previously announced conferences, one this spring and another later this year. Hall is no stranger to fund-raising. He was the man who initially presented the proposal to the Broad Foundation that resulted in a $25 million donation last month to USC for stem cell research. Hall's presentation was made three years ago, but he was pretty pleased with the outcome when we talked to him at the stem cell trial last week. Hall made the pitch while he was working at USC.
Also coming up is a meeting of interest to folks who are interested in receiving a grant from CIRM. The matter at hand is the grants administration policy that is being formulated by the agency. The Research Working Group will consider the proposal on March 14 at UC San Francisco. Some sort of teleconferencing is planned for remote locations, but the details are not available on the agenda.
The text of the proposed grants administration policy is also not available on the agenda, but you can find a summary here and the full proposal here.
This is likely to be more difficult than development of the policies on IP for non-profit institutions, which were approved last month. Money, of course, is the key: How to provide sufficient profit motive to stimulate development of therapies.
Patient advocates on the Oversight Committee have already indicated that they are likely to favor policies that will speed treatments. Watchdogs of the public purse are likely to be less generous with the results of state-funded research.
We are also likely to see more comments from the biotech industry. Look for the first public hearings on this issue late this month. Development of a complete policy is likely to take some months. If you want to weigh in with comments prior to the first hearing, you can contact the agency via its web site.
While the IP policy gets underway, Zach Hall, president of CIRM, says his top priority right now is fund-raising for two, previously announced conferences, one this spring and another later this year. Hall is no stranger to fund-raising. He was the man who initially presented the proposal to the Broad Foundation that resulted in a $25 million donation last month to USC for stem cell research. Hall's presentation was made three years ago, but he was pretty pleased with the outcome when we talked to him at the stem cell trial last week. Hall made the pitch while he was working at USC.
Also coming up is a meeting of interest to folks who are interested in receiving a grant from CIRM. The matter at hand is the grants administration policy that is being formulated by the agency. The Research Working Group will consider the proposal on March 14 at UC San Francisco. Some sort of teleconferencing is planned for remote locations, but the details are not available on the agenda.
The text of the proposed grants administration policy is also not available on the agenda, but you can find a summary here and the full proposal here.
Friday, March 03, 2006
The Stem Cell Trial: 'Reaching for The Water Pitcher'
The California stem trial is now in the hands of the judge, who is awaiting final written arguments that will be filed later this month.
The arguments will include statements from both sides and then a rebuttal from each. They are due by March 15.
The trial came to an end on Thursday with perhaps only one reporter in attendance, Andrew Pollack of the New York Times. He reported:
The stem cell agency also received some attention this week on "Forum," a program on San Francisco public radio station KQED. Discussing CIRM were Christopher Thomas Scott, executive director of the Stanford Program on Stem Cells and Society; California state Sen. Deborah Ortiz, D-Sacramento; Jesse Reynolds, project director on Biotechnology and Accountability, Center for Genetics and Society, and Pilar Ossorio, assistant professor of law and medical ethics, University of Wisconsin Law School. You can listen to the program here.
The arguments will include statements from both sides and then a rebuttal from each. They are due by March 15.
The trial came to an end on Thursday with perhaps only one reporter in attendance, Andrew Pollack of the New York Times. He reported:
"Don C. Reed, a supporter of stem cell research who watched the entire trial, said the plaintiffs seemed disorganized and nonaggressive.Reporter Paul Elias of The Associated Press took in Wednesday's proceedings. You can read his report here. Russell Korobkin, professor of law at UCLA and a senior fellow at the UCLA Center for Society and Genetics (not to be confused with the Center for Genetics and Society in Oakland), commented on the trial in an op-ed piece in the Los Angeles Times. He said the court challenge to the California stem cell agency was an example of "frivolous arguments" made "to obscure issues or just to create delay."
"'There was a great deal of reaching for the water pitcher,' said Mr. Reed, whose son was paralyzed in a football accident. 'It was not at all the savage attacks I had expected.'"
"What is most troubling is not that the plaintiffs' arguments lack legal heft but that they no doubt realize this, yet argue anyway. The three groups fighting Prop. 71 — two pro-life associations and an anti-tax organization — are not what you would describe as passionate about technical governance issues. But because they know the state cannot issue the bonds to fund research while litigation is pending, they are using weak legal justifications to delay the inevitable," Korobkin said.One of the attorneys in the case, David Llewellyn, is a graduate of the UCLA law school, but did not have the opportunity to study under Korobkin, who joined the faculty only in 2000.
The stem cell agency also received some attention this week on "Forum," a program on San Francisco public radio station KQED. Discussing CIRM were Christopher Thomas Scott, executive director of the Stanford Program on Stem Cells and Society; California state Sen. Deborah Ortiz, D-Sacramento; Jesse Reynolds, project director on Biotechnology and Accountability, Center for Genetics and Society, and Pilar Ossorio, assistant professor of law and medical ethics, University of Wisconsin Law School. You can listen to the program here.
Wednesday, March 01, 2006
Chron Story on Stem Cell Trial
The San Francisco Chronicle, in fact, carried a report this morning on the California stem cell trial. A couple of readers called it to our attention. It was the third item in a series of brief. Bernadette Tansey was the reporter.
Stem Cell Trial Coverage and Silent Testimony
News coverage of the California stem cell trial dropped sharply today with stories apparently only in the San Diego Union-Tribune and the Oakland Tribune. The San Francisco Chronicle sent a reporter Tuesday but apparently did not carry a story, based on a look at their web site.
The trial could be over today and is unlikely to produce any significant developments, which is why we aren't there today. The affair certainly will be over on Thursday. The next major development will be the filing of the final briefs and rebuttals by both sides.
Reporter Terri Somers of the Union-Tribune led with the focus on the constitutional issues involving CIRM and testimony by stem cell Chairman Robert Klein. She quoted Klein as saying,
But even at the worst stages, it would be hard for the plaintiffs to make the case that CIRM is outside of control of all state agencies. CIRM is certainly an extraordinary agency. Nothing like it has existed in California history. And it operates with greater freedom and lack of oversight than virtually any other branch of state government. But Tamar Pachter, deputy attorney general, has produced an impressive list of minor and major links between CIRM and other state agencies to make the case that CIRM is really a part of state government – not some other bureaucratic beast, as argued by plaintiffs. It was an enlightening display of how many state agencies could make serious mischief or worse for CIRM if it gets on the wrong side of some officeholders.
In another venue Tuesday, there was silent testimony to the weakness of the plaintiffs case. Advanced Cell Technology celebrated the relocation of its national headquarters to California, specifically Alameda, a small city on an island in San Francisco Bay.
Business reporter David Morrill wrote in the Oakland Tribune:
ACT obviously does not believe the plaintiffs will prevail in their attempt to kill off CIRM.
The trial could be over today and is unlikely to produce any significant developments, which is why we aren't there today. The affair certainly will be over on Thursday. The next major development will be the filing of the final briefs and rebuttals by both sides.
Reporter Terri Somers of the Union-Tribune led with the focus on the constitutional issues involving CIRM and testimony by stem cell Chairman Robert Klein. She quoted Klein as saying,
“I'm thoroughly under the control of a spectrum of agencies of the government of the state of California.”Reporter Rebecca Vesely of the Oakland Tribune wrote:
"Plaintiffs attempted to argue in Alameda County Superior Court that Klein, his board and agency staff operate outside state control and therefore violate state laws.You could say that Klein's position on the relationship between CIRM and other state agencies has evolved. Last spring, the CIRM-Legislature connection was nearly malignant, but has since become less virulent.
"'I'm extremely surprised by that concept,' Klein told the court. 'I am convinced we are under the authority and control of the state of California.'"
But even at the worst stages, it would be hard for the plaintiffs to make the case that CIRM is outside of control of all state agencies. CIRM is certainly an extraordinary agency. Nothing like it has existed in California history. And it operates with greater freedom and lack of oversight than virtually any other branch of state government. But Tamar Pachter, deputy attorney general, has produced an impressive list of minor and major links between CIRM and other state agencies to make the case that CIRM is really a part of state government – not some other bureaucratic beast, as argued by plaintiffs. It was an enlightening display of how many state agencies could make serious mischief or worse for CIRM if it gets on the wrong side of some officeholders.
In another venue Tuesday, there was silent testimony to the weakness of the plaintiffs case. Advanced Cell Technology celebrated the relocation of its national headquarters to California, specifically Alameda, a small city on an island in San Francisco Bay.
Business reporter David Morrill wrote in the Oakland Tribune:
"'We came to California from Massachusetts because it allows us to be in an environment that we really believe will be the center or hub of this industry segment for the next 10 years,' said William Caldwell, chief executive of Advanced Cell Technology. 'We feel California provides more opportunities than Massachusetts because it not only provides an openness to do the research, but they are also funding that opportunity.' Advanced Cell's new 15,000 square-foot headquarters at 1201 Harbor Bay Parkway in Alameda were formerly used by Avigen Inc., which also has its headquarters on Harbor Bay Parkway."
ACT obviously does not believe the plaintiffs will prevail in their attempt to kill off CIRM.
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