Friday, June 29, 2007

Klein Rep Says No Financial Ties in Land-Stem Cell Proposal

California stem cell Chairman Robert Klein, who owns a real estate development firm based in Palo Alto, is not financially involved in a land development proposal in Northern California that promises to create a stem cell research center, according to a Klein representative.

In response to questions from the California Stem Cell Report, Amy Daly, executive director of Americans for Stem Cell Therapies and Cures, Klein's private lobbying group, said:
"Bob Klein's company's is not at all involved in this project other than to allow Bob to donate his time to the endeavor. There is no monetary benefit for Bob in this project. He is not getting paid and there will be no financial (or other) benefit to his company as a result of this project."
She also said that CIRM is not connected with the proposal near Sacramento and is "completely separate." CIRM itself has had no comment on the plan. The agency said it knows nothing about it.

Daly's response came as the Center for Genetics and Society Friday published sharp criticism of the plan on its blog "Biopolitical Times."

Jesse Reynolds, project director on biotechnology accountability, wrote that the proposal raises a question of whether another stem cell research center is justified. He continued:
"The second issue is the egregious nature of Robert Klein's conflicting roles. His lobbying group gets a hefty donation, and his imprimatur hints that the new center would be a likely magnet for public financial support. And who knows if he's got his own finger in the pot, given that his business dealings are obfuscated via dozens of corporations and holding companies.

"Meanwhile, he sits as not only a public servant, but as one with significant influence over how billions of public dollars are spent. Although he's promised not to profit from biotech while he's chair of the state stem cell agency, does he consider an investment in the land development part of this vow? And how would the public ever know?

"Regardless, as we've said before, Klein needs to decide whether he is a lobbyist or a public official. He can't be both."
Daly said that Klein and Sacramento developer Angelo Tsakopolous met only recently. She said that they "have not worked on any project in the past."

She wrote,
"As I understand it, they met in January 2007 when they both were in Washington for inaugural activities. Both are strong supporters of Nancy Pelosi.

"Around that same time, Yolo County had put into their general plan a desire to have an economic development proposal. The Tsakopoulos family owns land there and they were hoping to leave some lasting legacy for the county beyond just immediate economic development.

"Bob and Angelo had dinner here in California upon their return and discussed the possibility of a Regenerative Medicine Institute in Yolo County. Angelo and his children were thrilled to have an opportunity to change the world much in the way we believe Proposition 71 will change it. As I mentioned in my email to you yesterday, we are hoping that this Regenerative Medicine Institute, funded by the soon to be formed non-profit, Bridge to Cures, will bridge the funding gap for translational medicine that currently exists and that CIRM has not yet addressed."
She said opponents are trying to stop the project, which will be discussed by Yolo County supervisors July 17, before it moves beyond the discussion stage.

See below for an information sheet on the Yolo stem cell proposal being circulated on behalf of the effort. Sphere: Related Content

Text on Development Plan Involving Klein

Here is the verbatim text of information supplied on behalf of a Northern California land development/stem cell research proposal involving California stem cell Chairman Robert Klein. It was supplied by the Sacramento political consulting and PR firm of Townsend Raimundo Besler & Usher.


Innovation Corridor

California and the nation face a serious shortage of comprehensive sites devoted to cutting-edge biomedical research, life science incubators and allied private enterprise support for university-related research and therapy development. A group of researchers, civic leaders and private entrepreneurs are working on a plan to provide the physical and economic infrastructure to support an international research center for regenerative medicine and biotechnology on Interstate 80 between Mace Boulevard and E. Chiles Road interchanges.

Life and Health Sciences – Leading California Into the Future

California is the world leader in life and health sciences and technological research. Biotechnology was born in California and today is one of the state's most important economic engines. A quarter of a million Californians work for more than 2,700 companies, making biotech a larger employer than the computer, aerospace, telecommunications or motion picture industries.

Demand for Research and Development Centers is Growing


Advanced R & D in the biosciences will be the most significant contributor to the well-being of Americans and to the nation's economic well-being for decades. That promise can only be realized, however, if researchers, civic leaders, universities, government officials and private entrepreneurs work together to overcome serious financial barriers and a shortage of sites where new therapies can be discovered.

Californians recently voted to make $3 billion available for stem-cell research but only $300 million for construction of sophisticated facilities to carry out that research. A leading California life sciences consortium recently found that high costs and a scarcity of approved R & D sites is a growing problem. It urged leaders "…to cooperate to identify areas where facilities (e.g., bio-research parks) can be located, to secure those areas, to provide incentives for development and for companies to locate there, and, most importantly, to maintain a level of ongoing support to keep these areas vital."

Innovation Campuses can Provide Infrastructure to Sustain R&D

Operational mixed-discipline research centers, life science incubators and therapy development centers cannot support themselves. Many potential tenants are start-up companies or non-profits. Most require venture capital, government subsidies, non-profit foundation grants and other support to provide working capital needed to carry a new medical therapy from validated discovery to clinical trial.

Regional Leaders Working with Yolo County to Identify Potential Innovation Corridor


The Yolo County Board of Supervisors has identified the Interstate 80 corridor between East Chiles Road and Mace Boulevard as a planning study area for a university-related research and development corridor. Regional leaders are working with the county to explore a practical plan to support the county's goal of a local environmentally sensitive, university-related R&D site.

Innovation Place Foundation to Provide the Incubator


Governed by a panel of leading local and international researchers, entrepreneurs and university representatives, an Innovation Place Foundation would develop a not-for-profit regenerative medicine and biomedical research incubator; support allied research in clean energy, agriculture and environmental sciences; and administer a for-profit mixed-discipline research park.

The foundation would operate with more than $200 million to provide working capital for research and therapy development advancing validated discoveries to clinical trials. Financial support would come from a share of the proceeds of ancillary and adjacent commercial and residential development that would follow SACOG Blueprint guidelines, provide a jobs-housing balance and protect agriculture and open space in step with Yolo County's heritage.
Sphere: Related Content

CIRM Faculty Awards Deadline in August

The big day – at least a day some scientists will not want to miss -- for the handsome faculty awards from the California stem cell agency is Aug. 9.

That is when the letters of intent are due from applicants for the $85 million program, which will provide salary and research support for up to five years for 25 California stem cell scientists. Arlene Chiu, CIRM’s interim chief scientific officer, said,

"These grants are designed to encourage newly independent investigators to pursue bold and innovative studies across the full range of stem cell types – human and animal, embryonic and adult. We will consider providing successful applicants salary and research funding for up to five years, ensuring that they have stable, secure financial support as they begin their independent scientific careers."

The awards are scheduled to be approved in December with cash actually coming next spring.

CIRM's press release can be found here. The RFA here. And an earlier item on the program here. Sphere: Related Content

Thursday, June 28, 2007

Klein and His Role on Proposed Stem Cell Research Center

The Northern California land deal/stem cell research center involving California stem cell chairman Robert Klein calls for him to head a new nonprofit group that would be endowed by the family of developer Angelo Tsakopolous.

In response to a query from the California Stem Cell Report, Amy Daly, executive director of Klein's lobbying group, Americans for Stem Cell Therapies and Cures, said,
"As you may be aware, there is a gap in funding in the life of therapy development where many good ideas for therapies and cures die for lack of funding. It is this funding gap that we hope to address with this project. California Institute for Regenerative Medicine has focused (and we believe will continue to focus) much of ithat come from early research and safely see them to the point in time where they are picked up by biotech and VCs (venture capitalists).

"We hope to inspire international collaboration by having board members from world-class institutions from around the world. These institutions, as well as UC Davis and other California institutions, will also have the opportunity to have satellite lab space near the incubator space that we are building for the therapy development."
She continued:
"This project will create a non-profit to bridge that funding gap and we believe it will be called Bridge to Cures. The family donating the land and endowment funds, the Tsakopoulos family, have asked Bob to chair the board of Bridge to Cures. The structure of the board will be similar to the Independent Citizens Oversight Committee with the addition of Angelo and Kyriakos Tsakopoulos and Eleni Tsakopoulos-Kounalakis. We expect that the board will choose to have working groups make recommendations to them similar to the working groups of California Institute for Regenerative Medicine. We hope to inspire international collaboration by having board members from world-class institutions from around the world. These institutions, as well as UC Davis and other California institutions, will also have the opportunity to have satellite lab space near the incubator space that we are building for the therapy development."
Daly's full statement is below. Sphere: Related Content

Amy Daly Statement on Bridge to Cures

We queried Amy Daly, executive director of the Americans for Stem Cell Therapies and Cures, concerning the proposal for a land development project and stem cell research center near Sacramento. Here is her response verbatim.

Bob and Angelo had been spending time talking about this project to fund therapy development around the same time that Americans for Stem Cell Therapies & Cures was holding a fundraising dinner at the home of Robin and Marsha Williams to retire the outstanding campaign debt. The suggested donation for a couple to attend this dinner was $125,000. Angelo is very supportive of stem cell research (as you can see by his incredible generosity with this project) and so he and his wife attended this dinner.

As far as the project referred to in the Sacramento Bee today, there are
many details that were discussed but not included in the article.

"No one tried to strangle Herceptin, but it came near to starving in the
cradle."

As you may be aware, there is a gap in funding in the life of therapy
development where many good ideas for therapies and cures die for lack of
funding. It is this funding gap that we hope to address with this project.
California Institute for Regenerative Medicine has focused (and we believe
will continue to focus) much of its funding to fill the funding gap in early
research. We hope to take the ideas that come from early research and safely
see them to the point in time where they are picked up by biotech and VCs.
An example of this funding gap is found in the history of the development of
Herceptin, as noted here:
http://www.nytimes.com/books/98/09/20/reviews/980920.20henigt.html?_r=1&oref
=slogin.

Without philanthropic financial support for Herceptin during that funding
gap, it would not have been developed to the point where Genentech picked it
up. It is now the number one choice for the treatment of certain types of
breast cancer and saves countless lives.

This project will create a non-profit to bridge that funding gap and we
believe it will be called Bridge to Cures. The family donating the land and
endowment funds, the Tsakopoulos family, have asked Bob to chair the board
of Bridge to Cures. The structure of the board will be similar to the
Independent Citizens Oversight Committee with the addition of Angelo and
Kyriakos Tsakopoulos and Eleni Tsakopoulos-Kounalakis. We expect that the
board will choose to have working groups make recommendations to them
similar to the working groups of California Institute for Regenerative
Medicine. We hope to inspire international collaboration by having board
members from world-class institutions from around the world. These
institutions, as well as UC Davis and other California institutions, will
also have the opportunity to have satellite lab space near the incubator
space that we are building for the therapy development.

This is an incredible opportunity to help further stem cell research and
mitigate human suffering and I am proud that our non-profit has chosen to
support this effort.
Sphere: Related Content

Klein Involved in Major Land Deal-Stem Cell Research Center Proposal

California stem cell chairman Robert Klein and a prominent Sacramento area land developer are involved in a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million.

Reporter Mary Lynne Vellinga broke the news in The Sacramento Bee this morning. The developer is Angelo Tsakopolous, who has been active in Democratic fundraising and a major Sacramento developer for decades.

Tsakopolous' company, AKT Development, also contributed $125,000 on April 17 to Klein's private stem cell lobbying group, Americans for Stem Cell Therapies and Cures, which grew out of the Prop. 71 campaign committee. The contribution was not reported in The Bee story.

The Bee story "raises serious and troubling questions, some of which originate from Bob Klein's dual role as chairman of the ICOC and a stem cell political advocacy," said John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights. He told the California Stem Cell Report:
"I've said repeatedly that the dual role is inappropriate and word of this deal and the suggestion that Klein is involved in it while taking contributions is even more troubling."
Klein's activities with the lobbying group have stirred other concerns in the past about conflicts in the case of a man to heads a state agency giving away $3 billion in public funds. (See below for links to previous items on this subject.) Klein still presides over his own development firm, which is based in Palo Alto at the same address as the lobbying group.

The stem cell agency said it had no comment on the development proposal. "We don't know anything about this," said Dale Carlson, chief communications officer for CIRM.

Vellinga wrote that the proposal appears to be in the concept stage, but Tsakopolous and his supporters have hired a well-known political consulting and PR firm, Townsend Raimundo Besler & Usher, and promoted the plan with Yolo County officials.

Vellinga reported:
"The plan is similar in approach to efforts Tsakopoulos has made in Sacramento and Placer counties, where he offered to fund an NBA arena and a university, respectively, with the proceeds from new development on agricultural land that is now off limits to building.

"As outlined Wednesday by Tsakopoulos' spokesman, Jeff Raimundo, the Yolo proposal is short on specifics, such as how much housing, office or retail space he would seek permission to build on about 2,800 acres of land he controls between the city of Davis and the Vic Fazio Yolo Wildlife Area.

"In meetings with Yolo officials, including a dinner held at the Sutter Club in downtown Sacramento, Tsakopoulos and his supporters have stressed the benefits of the stem cell facility but have offered little detail about what it would take to finance it."
Vellinga continued:
"'Bob and Angelo thought this up,' Amy Daly, executive director of the Alliance for Stem Cell Research, said of the new idea for a research center. 'My understanding is that Angelo is looking for a legacy he can leave. He wants to do something big. And Bob lives, eats and breathes stem cell research.'

"Daly, who worked with Klein on the stem cell initiative, also is helping promote the Tsakopoulos plan. She said there is a significant funding gap for research that's beyond the basic stage but not ready to hit the market. The new center could fill that gap, she said."
Daly also worked for the California stem cell agency as director of patient and medical organization relations from Jan. 14, 2005, to Nov. 25, 2005.

Raimundo told the California Stem Cell Report that Yolo County supervisors "first started the dialogue about a biomedical research corridor." Raimundo said the project had a goal of generating a $200 million endowment for the center, although there were no details how the funds would be raised. He said any development would likely include residential and commercial building.

He told CSCR:
"This is a real convergence of a county that wants to boost its economic development and is willing to look at biomedical research complexes along I-80, a biotech community looking for research incubators in a comprehensive university-oriented R&D complex with allied ventures, and a willing and enthusiastic landowner.

"No specific plan has been created yet, but what ultimately is built here will be determined by the county as part of their general plan update."
Simpson, of FTCR, said,
"I'm extremely doubtful of a commercial real estate project that tries to ride on the coattails of 'stem cell research.'

"Many questions need to be answered about this deal by both Angelo Tsakopoulos and Bob Klein.

"A good start for Klein would be to decide if he wants to be chairman of the ICOC or of his political advocacy group. He should not serve as both."
Here are links to some previous items on Americans for Stem Cell Therapies and Cures. "Ongoing Threat," "Background Statement," "Two Hats" and "Unseemly Position."

(Personal disclosure from the California Stem Cell Report: Raimundo is a friend and former colleague at The Bee. Vellinga is also a former colleague. I have met Tsakopolous on several occasions and have directed news coverage of some of his enterprises. I have exchanged email with Markos Kounalakis, Tsakopolous' son-in-law and president of the Washington Monthly, and once submitted an article to that magazine that I ultimately withdrew from consideration because of the length of the editing process.) Sphere: Related Content

Wednesday, June 27, 2007

Kuehl on CIRM Bill: Breathing Room, Yes -- Abandonment, No

In what may be the only mainstream media story on the subject today, the San Jose Mercury News quoted a powerful state legislator as saying she is not giving up on her legislation to guarantee the state a better return on its $3 billion stem cell research investment.

Reporter Steve Johnson quoted Sen. Sheila Kuehl, D-Santa Monica, chair of the Health Committee, as saying,
"I'm not abandoning the issue in any way."
Johnson wrote:
"Delaying the measure until the institute completes its (intellectual property) policy 'would remove one more thing they could say in opposition to my bill,' she said."
Johnson also quoted Dale Carlson, chief communications officer for CIRM, as saying the agency appreciates "being able to finish their policy without having to worry about legislators passing a competing one."
"We begged and pleaded for time to complete our regulatory process and it appears that's what they're giving us."
For more on SB771, see the items below. Sphere: Related Content

Tuesday, June 26, 2007

CIRM Legislation: A Political Muscle Story or Casualty of a Full Plate or Both?

The legislative effort to step into the affairs of the California stem cell agency attracted virtually no public notice during its short life this year.

Only a handful of stories – or less – recognized the existence of SB771 (see item below).

But John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, has been active in the area involving the legislation and is a regular presence at CIRM meetings. He was acutely aware of the measure.

Today he issued a news release that said the legislature "missed an opportunity to ensure affordable access to any stem cell discoveries financed by California taxpayers."

Simpson continued:
"Sadly, both the proposed bill and regulations being developed by the stem cell institute fail to protect consumers from the possibility of unreasonable pricing of discoveries resulting from research they paid for. The bill was really about political muscle and how much influence the legislature should have over the stem cell institute, not the people's interests."
Another analysis could also note that the bill's author, Sen. Sheila Kuehl, has a very full legislative plate and that winning passage of the measure would be akin to winning the California lottery. In a word, remote.

Whatever the case, Simpson's statement and the shelving of the legislation are likely to attract little – or less – attention in the media. Sphere: Related Content

CIRM Legislation Finished for 2007

Legislation to ensure a fair return to the state on its $6 billion stem cell research investment and to provide affordable access to any resultant therapies has been shelved for at least the remainder of the year.

A spokesman for Sen. Sheila Kuehl, D-Santa Monica, lead author on SB771, said the measure was put off to allow the stem cell agency to finish its regulations for intellectual property, the vehicle for determining how to split up potential largess from stem call products.

The spokesman, Peter Hansel, said that if the regulations "come up short," the authors of the bill intend to push it in 2008. Sen. George Runner of Antelope Valley, one of the legislature's Republican leaders, is also an author of the bill.

Hansel said,
"In the near term, the bill is going to be used to used for another unrelated purpose, but the authors intend to amend its provisions into another Senate bill in the Assembly once we identify a vehicle that is not moving. This should be viewed as a temporary move and not as any diminishment of the authors' underlying commitment to the issue."
The bill was opposed by CIRM and the California biotech industry. It easily passed the Senate. But to become law it needs a super, supermajority vote (70 percent) as well in the Assembly and the signature of the governor, who is a strong supporter of CIRM. Sphere: Related Content

No Action Today on New CIRM President

Directors of the California stem cell agency met Tuesday in executive session to discuss candidates to fill the vacant post of president of the $3 billion enterprise, but came to no public decision.

Dale Carlson, chief communications officer for CIRM, said the special, teleconference meeting of the Oversight Committee adjourned without acting on a public agenda item calling for consideration of presidential compensation and candidates.

At this point, one can only speculate on why those matters were placed on the public agenda if no action was planned. One explanation is that hopes existed that a deal with an applicant could be concluded in time for the meeting, but for some reason an agreement could not be reached. State law does not permit the Oversight Committee to act on matters without adequate public notice.

Former president Zach Hall announced last December that he would leave the agency this month. In April, he said he was leaving earlier following a contentious meeting of the CIRM Facilities group.

The first presidential search was prolonged as well, missing the Oversight Committee's self-imposed deadline in 2005 by three months. Sphere: Related Content

Monday, June 25, 2007

Presidential Search Committee Anticipates No Public Action Tonight

The presidential search subcommittee of the California stem cell agency has begun its meeting but is not expected to announce any action tonight.

Dale Carlson, chief communications officer for CIRM, said the group convened its teleconference meeting and promptly went into executive session to consider presidential selection issues. He said the group was not scheduled to make an announcement this evening.

The full Oversight Committee meets tomorrow morning at 7 a.m. to consider presidential salaries and candidates. Sphere: Related Content

Coming Up

The presidential search subcommittee of the California stem cell agency meets at 5 p.m. California time today (midnight Greenwich Mean Time 6/26) with an unusual international teleconference meeting of the full Oversight Committee scheduled for 7 a.m. California time (2 p.m. Greenwich) tomorrow.

Presidential compensation and candidates are on the agenda for the Oversight meeting. But first they will pass through the subcommittee.

We expect to bring you coverage of any action by the subcommittee tonight, which will be largely behind closed doors, if anything is announced. The meeting is estimated to run for perhaps two hours. Sphere: Related Content

Internet Radio Program: Stem Cells After Bush

The award-winning California public radio program, Forum with Michael Krasny, Tuesday morning will explore stem cell issues in the wake of the presidential veto.

The KQED program will begin at 9 a.m. Pacific Daylight Time and can be heard live on the Internet as well as downloaded after the broadcast. You can find directions on how to tune in on your computer at this location.

Scheduled to appear are bioethicist and law professor Alta Charo, Christopher Scott, executive director of the Stem Cells in Society Program at Stanford, and Dale Carlson, chief communications officer for the California stem cell agency, as well as yours truly, David Jensen, the publisher of this web site..

Listeners can call in with their questions on a toll-free number, 866-733-6786. Comments can be sent in to forum@kqed.org Sphere: Related Content

CIRM Plan: $85 Million Split Among 25 Stem Cell Researchers

Polish up your resumes, folks. The California stem cell institute is preparing to give away $3 million a year or so to 25 promising, "young" researchers and physician-scientists. The money could be awarded as early as next winter.

The concept for the five-year program was approved by CIRM's Oversight Committee earlier this month. It is aimed at drawing the best and brightest into stem cell research in California -- and not just embryonic stem cell research.

The $85 million proposal encountered virtually no opposition at the Oversight Committee meeting. However, it did shed some light on issues related to have and have-not institutions, quality of grant recipients and spreading the CIRM wealth geographically around the state.

Arlene Chiu, interim chief scientific officer for CIRM, presented the concept to the ICOC. She told the board:
"Independent scientists at this early stage in their careers are very vulnerable...because they face a number of challenges: Tight federal funding pressures to get data and results out quickly, to publish papers, and demonstrate productivity and the potential of their work. They also must get grants to support their fledgling labs. And last, and certainly not least, physician-scientists often have to have clinical service as well. Faced with these challenges, plus the restrictions and uncertainties imposed by the presidential policy on human embryonic stem cells, it's not surprising that many new faculty are discouraged, feel discouraged from rushing into this new field."
Under the plan, the awards would go to persons who hold fulltime, faculty-level positions at academic or non-profit institutions in California and who are "young," meaning in the early stages of their careers. Academic institutions with a medical school could submit four applications in support of new Ph.D.'s and two new physician-scientist faculty members. Institutions without a medical school would be limited to two applications. The grants would go for research, salaries and possibly educational loans. They are akin to Pioneer grants awarded by the National Institutes of Health.

Chiu said the cap on the applications from each institution was needed to keep the total number from become unmanageable given the problems of processing them with CIRM's small staff. Ed Penhoet, vice chairman of the ICOC, said the total could hit 600 or 700 without a cap. He said he was more concerned about the load on grant reviewers, who come from out-of-state.

Philip Pizzo
, dean of the the School of Medicine at Stanford, and others advocated no institutional cap on applications. Pizzo said,
"This is a very big award that you're putting forth, that it's best to have the very most outstanding individuals."
Later he said,
"I'll say this carefully, and I hope no one will be offended. I think we must have a very high standard. The tendency that we've had recently is we're trying to spread things around, and I think it's good. We should do that, but we should have a high bar on these grants and not simply come in and say,well, we need to have many more of them to sort of prime the seat. I think that would be going in the wrong direction."
David Baltimore, former president of Caltech and a Nobel Laureate, replied,
"There are only 25 grants. If four of those grants were given to one institution, that would be probably scandalous. For six grants to be given to one institution would certainly be scandalous when it's such a limited resource for the state."
Also speaking for limits on each institution were Oversight Committee Chair Robert Klein, Claire Pomeroy, dean of the School of Medicine at UC Davis, and patient advocates Jeff Sheehy and Sherry Lansing, a former Hollywood film executive. .

At one point, Oswald Steward, chair and director of the Reeve, Irvine Research Center at UC Irvine, supported Pizzo as did Duane Roth, chairman and CEO of Alliance Pharmaceutical Corp., who said he favored stringent criteria for the awards.

The discussion of the faculty award program reflected some of the questions recently rippling through CIRM. Do the big, well-established programs continue to receive generous grants? How much should go to institutions without the reputations and facilities that UC San Francisco and Stanford have? Should the location of institutions be a consideration? Does spreading the money around mean that unworthy science is being funded? Does it dilute funding for what is very expensive research, a question raised by Penhoet, who said,
"I just wanted to caution against trying to cut the budgets and spread it around over more people. This is a disease most prevalent at the National Science Foundation. You end up with lots of people with not enough money to do anything important. So I think we're better off to choose the very best people and fund them well rather than try to spread the money further. This research is expensive. Salaries are high, all of these things. It takes a lot of money to do modern cell biology and microbiology."
The questions of sharing the wealth have surfaced particularly during recent sessions of the Facilities group, which is developing criteria for a $200 million research lab construction program. The issues are likely to surface anew on July 12 when that group actually writes the specifics.

As for the faculty awards, Chiu will bring back more specifics to the ICOC in August. Review of applications, which she estimates could come from as many as 35 institutions, is tentatively scheduled for this fall. Approval of grants could come during the holiday season. Consider them a Christmas bonus. Sphere: Related Content

A Retrospective on CIRM: The View from Wyoming

The former president of the California stem cell agency – Zach Hall -- reflects on his two years in the job, CIRM's accomplishments and the challenges facing in the $3 billion program in a piece in the San Diego Union-Tribune.

Reporter Terri Somers wrote the Sunday story on the eve of this evening's and tomorrow's meetings dealing with the appointment of a new president. Hall had planned to leave the agency this month, but accelerated his departure following an acrimonious session of CIRM's Facilities group.

Hall was circumspect on some topics, including the longstanding structural problems at CIRM with its dual executive arrangement that is locked into state law by Prop. 71.

Nonetheless, Somers' story offered some insights. She wrote that the president has no clear voice in grant funding. Hall noted that the CIRM president has no seat on CIRM's controlling body, the Oversight Committee, as contrasted to the NIH. Hall said:
"Proposition 71 poses an administrative challenge in that it gives significant leadership responsibility to both the chairman and president. In a small organization, which at the time I was president it was, two strong leaders often posed a challenge. Both of us had (previously) been in leadership positions and had strong views about how things should be done.

"This sometimes led to conflict. In the end, results can best be judged by the record of accomplishment of the institute."
Hall on relations with Oversight Committee members:
"'In retrospect, I think I could have probably worked harder to improve my relations with some of the board members. I think it wasn't clear to me as early as it might have been how important that was,' Hall said. 'I mostly confined my interactions to official occasions, and I think it would have helped if I did some things to meet with people individually.'"
Somers continued:
"There are a number of internal problems at CIRM that need to be worked out, he said.

For example, there needs to be a unified vision among the groups represented on the board and the staff, he said.

"'I hope that out of that process would come a strong sense of mutual trust, which I think was one of the issues at the facilities working group meeting.'"
Hall on relations between CIRM staff and the 29-member Oversight Committee, which sometimes engages in micromanagement (our word, not Hall's):
"The institute has a tremendously talented staff and I think it is important the board trust the staff to do its work, and work in the direction that is congenial with where the board wants to go. There needs to be a sense that the board doesn't need to participate in every decision, or be involved in all details of the administration."
Hall on the private sector and the future:
"The institute's next president, he said, could really make an impact by developing a strategy for working with private industry. So far, the institute has developed plans only for dealing with nonprofit research institutions and universities. Ultimately, the institute wants to partner with companies by helping with clinical trials and getting therapies to patients.

"'This is a whole new territory, and we don't have good models,' Hall said.

"'Because of the way the field has developed, a lot of important discoveries have been made on the private side, and we don't always know what they are. We need to know who it's worth putting money into, while not violating their need for confidentiality, which will be a challenge.'"
Hall's plans? Enjoy the summer at his place in Wyoming and serve on the scientific advisory board of the New York Stem Cell Institute. Sphere: Related Content

Coming Up

Later today, we will have a look at CIRM's plans to establish an $85 million program to fund as many as 25 California physician-scientists with as much as $400,000 a year. Sphere: Related Content

Friday, June 22, 2007

NAS Letter Arrives

We have received word from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, that he has now received (on June 21) a response from the National Academy of Sciences regarding his letter of protest about his ouster from a stem cell meeting in May. The NAS letter to him was dated June 13 and postmarked June 15. Copies of it were also sent to some other parties, one of whom received it as early as June 14. We carried an item on the NAS response last week based on the copy of the letter. Sphere: Related Content

If It Can't Stand the Light of Day...

Attention Scientists! Want to keep the gravy train moving and the research grants flowing? Want to see more shiny new labs with the latest in sparkling equipment?

Build public confidence. Open the doors and explain the mystery. Don't shut out the people. Don't feed the anti-science Luddites.

Much has been written about distrust of scientists and their arcane ways. Most people are more concerned about the pedestrian issues of daily life than the esoteric issues that researchers probe. The public turns its attention to scientific matters in times of major achievement but also in times of scandal and suspicion. And when little is known about a subject, bad information can easily carry the day in the court of public opinion.

Which brings us to the National Academy of Sciences and its closed door sessions on the seemingly innocuous subject of interstate cooperation on embryonic stem cell research. We have written a few times about how the academy ousted a member of the public from its meeting on the matter last month in California. The academy apparently plans to continue this dubious policy.

Today the question is: Why should you care? The answer: If you favor good science, well-funded by government, you have something at stake.

Can scientists be trusted with public money? Are they open to public concerns? High-handed tactics, closed door meetings and secret agendas generate negative responses to those questions and play into the hands of those who fear science and seek to bring it to heel. No good reason exists for barring the public from the meetings on interstate cooperation. The meetings are attended by public officials discussing public policy about billions of dollars in public money.

The NAS itself owes its existence to an act of Congress. Many of its proceedings are already public, including such sessions as one dealing with adverse biological and health effects of cell phones and another dealing with "The 1,000-ship Navy -- A Distributed and Global Maritime Network." Is interstate cooperation on stem research more "sensitive" than those issues? We think not.

In many cases, the NAS has the legal right to close its doors. But the various state stem cell officials should not be party to such proceedings concerning interstate cooperation. We have queried a number of participants in May's closed door meeting to see if they planned to continue to attend meetings that bar the public. None has responded although we promised to carry their comments verbatim. Several possible reasons exist for the non-response. The officials may feel that this flap -- a relatively minor matter in many ways at this point -- will go away. They may feel uncomfortable as public officials in stating that they approve of closed door meetings. And they may be unwilling to publicly offend the National Academy of Sciences.

The NAS itself has not responded to our repeated queries. It also has not responded even to questions about the date for the next interstate meeting. And its written response to the man ousted from the May meeting was delivered to him one week after it went to agencies that were copied in on the letter.

When we worked in the California governor's office years ago, we were sometimes asked by top appointees about public meetings. Our response was, "If it can't stand the light of day, don't do it." That is good advice also for the National Academy of Sciences and its meetings on stem cell cooperation.

(Editor's note: An earlier version of this contained slightly different information re the NAS response to the ousted man. This item has been updated to reflect the latest information.) Sphere: Related Content

Thursday, June 21, 2007

TV Coverage on California Stem Cell Research

California's $3 billion stem cell research program received favorable mention in some television news coverage of the president's stem cell veto.

We mentioned the ABC News blog item earlier. The same reporter, Ned Potter, who wrote the blog also prepared a piece for the network's national news program, which carried on camera commentary from Arnold Kriegstein of UC San Francisco and Dale Carlson, chief communications officer for CIRM.

In Sacramento, Channel 10 carried a piece by Marcey Brightwell that discussed California's program with a special focus on UC Davis and researcher Jan Nolta.

As we have mentioned earlier, TV news coverage is important because more people get their news that way than by reading the newspaper. TV news coverage of the California stem cell agency is also rare.

You can see the actual video of the stories by clicking on here for Channel 10 and here for ABC. Sphere: Related Content

A Dissection: CIRM's Presidential Meeting Next Week

A couple of alert readers have raised questions concerning next Tuesday's special meeting of the Oversight Committee of the $3 billion California stem cell agency, which is scheduled to consider presidential candidates and a new salary for the position.

The teleconference meeting will be conducted from sites that span the length of California, reaching even into Australia. They offer an unusual opportunity for the public to take part in discussions of the agency.

Veterans of California state public meetings have some idea how this might work. Others are not entirely clear and wonder whether it really meets the requirements of state open meeting laws.

One stem cell observer, who asked for anonymity, wrote in an email:
"I have this image of a large crowd being ushered in and immediately being ushered out, waiting 90 minutes and then being ushered in and then out again."
That observer is not far off. However, it is unlikely that a large crowd will be on the scene at any of the locations. Most Oversight Committee meetings draw only about 10 or so members of the public, and that is when the meeting is only in one location.

We could be wrong, but this is likely how the session on Tuesday morning will go.

The committee will convene in public. It will then go into executive session to consider personnel matters – the hiring of a new president. Such sessions are permitted by state law. The public will have to wait outside the meeting room while this goes on. Then the meeting will go public. At that point, the committee has the ability to vote on the salary for a presidential candidate in public session and a new president because the matters have been properly noticed as required by state law. The committee does not have to vote on those matters. They could be delayed to another time. But once the committee is back in public session, members of the public can address the presidential topics or any other topic they choose. However, by state law the committee cannot act on matters that have not been announced in advance.

That means that a person could show up at one of these locations, sit around for about 90 minutes or so and not hear any significant discussions of CIRM matters. Unless you are interested in saying something to the directors of the $3 billion research effort, it may not be worth your time to attend the meeting. Or you may want to test public access -- required by law -- to site locations around the state for the teleconference meeting.

Will the new president be announced or voted on at Tuesday's meeting? Probably, but again we could be wrong. There is only one reason to put consideration of presidential candidates on the agenda, and that is to vote on them. One possible scenario is that the candidate is all but in the bag, with only ratification of a new salary or compensation package needed to clinch the deal. Another scenario could be that California stem cell Chairman Robert Klein put consideration of presidential candidates on the agenda just in case the deal would come to fruition in time for the 7 a.m. meeting next Tuesday. But given the unusual nature of the session, that may be unlikely.

Finally, if the Oversight Committee does fail to make a decision on Tuesday, it could mean that some sort of snag has once again hit the presidential selection process. Sphere: Related Content

Stem Cell Research State by State

Stateline.org today carried a detailed overview of embryonic stem cell research efforts state by state, including the case of a woman who unsuccessfully tried to donate a leftover embryo from her IVF treatment in Michigan.

She was told she had to go to another state because Michigan law bans research on human embryos.

Writer Christine Vestal put together the piece, which goes into some detail on each state with links to the agencies that do the work.

Here is an excerpt:
"Seven states — California, Connecticut, Illinois, Maryland, New Jersey, New York and Wisconsin — are providing seed money for the fledgling science, and Massachusetts Gov. Deval Patrick (D) in May called on lawmakers in his state to follow suit.

"Six other states — Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota — ban the research. Three states — Iowa, Massachusetts and Missouri — have affirmed its legality but do not offer funding.

"In Florida and Texas, lawmakers are deadlocked on the issue. Most states have steered clear of it altogether."
Sphere: Related Content

Wednesday, June 20, 2007

The Bush Veto: 'Strong Words From the Government of California'

California today received prominent mention on an ABC News blog by science correspondent Ned Potter concerning the presidential veto.

Here are some excerpts:
"Surprisingly strong words from the government of California, which, for lack of federal funding, is the largest backer of research on embryonic stem cells.
Potter continued:
"Dale Carlson of the California Institute for Regenerative Medicine, which handles the $3 billion California has pledged for research over ten years: "California has 25 percent of the biomedical research capability in this country. We need the other 75 percent fully engaged and pursuing these therapies.

"If therapies are going to be discovered we need labs all over the country working on this project. So we’re going to have to wait for a new president and hopefully a new policy to really achieve the potential."
Potter also said Arnold Kriegstein of UC San Francisco expressed "polite frustration" with Bush's position that research can be done without embryonic stem cells. Potter quoted Kriegstein as saying,
"There's been a great deal of discussion about alternative sources for embryonic stem cells, for example using amniotic fluid or umbilical blood and so forth. But the truth is none of these alternatives really have the potential embryonic stem cells do to create cells of different types--heart cells, muscle cells, nerve cells and so forth."
Sphere: Related Content

Klein on Bush

President Bush's predictable veto of the federal stem cell bill generated the following response from Robert Klein, chairman of the California Institute for Regenerative Medicine:
"The President has again dashed the hopes of millions of Americans suffering from chronic diseases and conditions, despite the overwhelming support for stem cell research in this country. If we're going to realize the potential of stem cells to treat Alzheimer's, Parkinson's, diabetes, multiple sclerosis, cancer, and 70 other debilitating conditions, we need scientists in every state carrying on this research. California cannot reach the potential of this medical research alone.

"It is a tragedy for patient families throughout this country that this critical new frontier of medical research has been so severely handicapped by the President’s personal religious positions. The Congressional leadership clearly understands the historic potential of stem cell research to reduce human suffering. The Congressional leadership should be commended for serving as the champion of stem cell research in this historic opportunity to impact the devastating medical impact of these terrible, chronic diseases and injuries on America’s children and families."
Sphere: Related Content

Down Under With The Niche and Robert Klein

California stem cell Chairman Robert Klein hobnobbed this week with scientists from around the world in Cairns, Australia, at the convention of the International Society of Stem Cell Research.

"The Niche," the new stem cell blog of Nature magazine, reported on some of Klein's doings at the conference, saying that Klein is joining the advisory board for the society. Monya Baker reported that Harvard scientist and incoming president of the society George Daley says Klein is supposed to help ISSCR "figure out what its mission should be."

She said that Daley also wants a "very philanthropically involved" board so the group does not always have to be raising funds.

Baker continued:
"I’m waiting to talk to Klein right now, sitting on the edge of a platform as the crew dismantles a stage in wet Cairns, Australia. He’s talking to three intent people, one a lady in a wheelchair. I’m catching words like 'motivating people' and 'networking' Behind him, a serious-looking woman is taking copious notes. I wish my hand moved that fast. She’s the one who led Klein away when I tried to talk to him."
The headline on Baker's item described Klein as the "Prop. 71 instigator." Sphere: Related Content

San Diego Stem Cell Consortium Unveils Ambitious Plans

Representatives from the high-powered San Diego stem cell consortium laid out their vision Tuesday for a 135,000-square-foot facility to house scientists, engineers, ethicists and to serve as a home for programs for both junior research scientists and senior scholars.

Reporter Terri Somers of the San Diego Union-Tribune reported on the presentation, which was made to the California stem cell institute. It held a hearing in San Diego as part of its effort to devise procedures for giving away $220 million to build embryonic stem cell labs in California.

The consortium consists of the Salk, Burnham and Scripps institutes as well as the University of California at San Diego. Tuesday's hearing was the first time members of consortium had appeared in public together, Somers reported.

She wrote that at least one group favored the consortium's effort:
"'I don't know why the consortium emerged or how they did it, but the fact that it has is one of the key developments that Proposition 71 (the stem cell initiative) envisioned,' said John (M.) Simpson of the Foundation for Taxpayer and Consumer Rights.

"Proposals for such collaboration should be given extra weight in the grant application process, Simpson said."
Not everyone is enamored of the effort. Somers did not report any negative comments on the CIRM or consortium plans, which were probably not made at the session. But one reader of the newspaper's Web site, identified only as "ghoward79" filed this online comment on Somers' story:
"If it has such promise then private investors would be all over it. Think about the investment returns! Either way companies promoting this are making money off it and they want someone else to pay the price."
Tuesday's hearing was the last before a July 12 session of the CIRM Facilities Group to actually come up with the specifics of the lab grant procedures, which would then go to the Oversight Committee for approval.

Earlier sessions of the group were well attended, drawing more attendees than the meetings of the Oversight Committee. Transcripts from the sessions are available online. Institutions planning to seek grants or other interested parties would be well advised to read the transcripts. Additional comments can also be sent to CIRM staff, which is mulling over the proceedings in preparation for July's hearing. Waiting until the day of the hearing is a good way to be overlooked. Sphere: Related Content

Tuesday, June 19, 2007

Time Ripe for CIRM Webcasting

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, made the following observations via email on the meetings of the Oversight Committee of the California stem cell agency.
"Given problems with quorums I have no problem with telephonic meetings SO LONG AS THE PUBLIC HAS GENUINE ACCESS.(Simpson's capitalization)

"Also think regular meetings should be broadcast on the Internet."
Some time ago we asked CIRM about Webcasting Oversight and other committee meetings. Expense was the reason given for not carrying the sessions on the Internet. CIRM Oversight meetings (currently about six a year) currently run about $20,000 a pop. If one or two could be eliminated each year and replaced with an online session, perhaps the money could be found. An online session capability would also help with meetings of the working groups, where many folks have to travel from out of state.

On the other hand, providing online meeting capability on a free basis would be an excellent opportunity for a high tech firm, such as Cisco or Citrix, which has a substantial California operation, to show its interest in supporting a worthwhile scientific and medical endeavor. It might also simply be good marketing and give a firm an entry point in a sector that is scattered around the globe. Sphere: Related Content

Reaching Down Under: A Chance to Weigh In on California Stem Cell Matters

It is not often that the folks in Australia have a chance to sit in on the deliberations of the elite group that operates the largest single source of funding in the world for embryonic stem cell research.

But next Tuesday all of you folks down under will have a chance, particularly if you are already in the Melbourne area, which, unfortunately, is quite distant from the big stem cell conference this week in Cairns. Likewise, Californians throughout the state will have a rare chance to easily be part of the discussions of the Oversight Committee of the California Institute for Regenerative Medicine.

The occasion is an unusual teleconference session of the 29-member Oversight Committee to consider candidates to take over as president of the $3 billion research program as well as their compensation.

The conference call arrangement was set up because it is physically difficult to bring together all 29 directors of the institute.

Three sites are available in San Francisco and two in Los Angeles, not including one at UCLA and one in Pasadena . Locations are also available in Sacramento, Chico, La Jolla, Newport Beach, Carlsbad, Stanford, UC Berkeley, Mill Valley and Healdsburg. The specific addresses can be found on the meeting's agenda.

A couple of tips: Some of the addresses do not include room numbers, such as the one for the Westin Hotel in Melbourne. That is apparently where Robert Klein, chair of the agency, is staying. Query CIRM in advance at info@cirm.ca.gov if you have questions about the specific locations. Also show up well in advance in case some officious type is inclined to delay your entrance. By law, these are public meetings. If you are hampered or barred from entry, please send me a note at djensen@californiastemcellreport.com.

The meeting promises to be short, perhaps 90 minutes, and only has the presidential matter on the agenda. If you like, you can also sit in on the presidential search subcommittee meeting the previous evening at many of the same locations. Sphere: Related Content

Ticklish Topic: The $400,000-plus Salary at CIRM

Whatever the new president of California's $3 billion stem cell research effort is paid, the salary will likely trigger complaints that it is too much.

Currently the top end of the salary range for the position stands at $412,500. The previous president, Zach Hall, earned $389,000.

However, CIRM's Oversight Committee meets on June 26 to consider compensation for its soon-to-be-hired new president. The committee's public agenda does not list the amount being considered, but it certainly is not going to lower the president's pay.

The salary is ticklish because it appears to be quite large for an operation that has less than 30 employees. Salaries of public officials are always touchy because they are easy for the public to grasp. Is $10 million too much for a lab at UC San Francisco or a research grant to UC Riverside? The public has no frame of reference, so it is hard for them to become outraged. But everybody has a frame of reference for wages. High salaries also make good headlines for newspapers, whose historically underpaid reporters and editors are keenly tuned to such matters.

CIRM often uses the University of California as a benchmark for salaries and financial practices. But you may recall, the UC system stubbed its salary toe in 2005 with dubious pay policies. Nonetheless it is useful to consider some of the salaries at UC. We will use a compensation list for 2004-05 compiled by the San Francisco Chronicle because it is easily available.

As of that fiscal year, one assistant professor at UC Davis, Kee Kim, was paid $776,943. Two members of the CIRM Oversight Committee -- David Kessler, dean of the UC San Francisco School of Medicine, and Gerald Levey, dean of the UCLA School of Medicine – earned respectively $540,250 and $537,416. Several persons whose main responsibilities are supervising young men as they play with balls easily topped those levels, with one at UC Berkeley, Jeff Tedford, topping out at $1.6 million. And those figures are all at least two years old.

If you look at the private sector, it is difficult to come up with useful comparisons. CIRM is a tiny agency (with fewer employees than directors) but it operates a massive research spending program. To issue the grants and administer them requires a high level of bureaucratic and scientific skill. To manage and lead those highly skilled CIRM staffers requires an equally skillful president. Not to mention the special adeptness needed to deal with the 29-member Oversight Committee and its chairman, who seems irresistibly drawn into the president's areas of responsibility. And not to mention the nearly uncharted research standards and IP waters that CIRM must navigate from time to time.

Complicating the pay picture are housing prices in San Francisco, which present a special problem for a president coming from out-of-state. The median price for a San Francisco home was $835,000 last month, up 8.4 percent from a year ago. And this is supposed to be a down market – at least nationally -- for housing. Keep in mind that price does not put you in the lap of luxury either.

The Oversight Committee seems heading relentlessly for a pay hike for its president. Its biggest challenge is to concoct a rationale that will mute the protests about the pay. A rationale that will sit well with Betty and Bob in San Bernardino, who are working two jobs and commuting (at $3.50 a gallon) more than four hours a day -- between them -- to pay for a very modest three-bedroom home for themselves and their two children.

One good way to start is to tell the public well in advance of next week's meeting what is exactly on the compensation table, instead of springing the figure at the last minute. Of course, if the amount is not defensible, withholding it may seem to be the best tactic -- at least to some. Sphere: Related Content

Monday, June 18, 2007

Fresh Comment

A comment has been posted anonymously on the "new look" item below. To see it, click on "comments" at the end of the item. Sphere: Related Content

Sunday, June 17, 2007

CIRM Has a New Look on the Internet

The California stem cell agency has a new look on its Web page, a redesign dictated by the eServices Office of the Golden State.

The ostensible reason is to create uniformity among state Web sites. So the eServices Office dictated, among other things, that a photograph of Gov. Arnold Schwarzenegger and a link to his site be placed on the home page of each state agency.

By November, all state departments must be marching together online.

Based on an initial look, CIRM's new design seems graphically friendly, although it will require a little re-orientation for those who those who are accustomed to the old look.

Several issues emerged, however. The most egregious problem is a failure to post prominently an email address that can be used to contact the agency. The email address should be on the "contact" page. At first we did not think it was anywhere on the site. But we finally found it buried deep on the "regulations" page.

The home page also does not have a link to upcoming meetings. Those can be found by clicking on "calendar" and then on "2007 Past Meetings." The transcripts of meetings are also found under "calendar," which is a tad non-intuitive. Once you are on the transcripts page, the transcripts are listed in a table that reads oddly -- at least to us. The widely separated columns in the table -- a format that seems to invite reading down -- are actually organized to read left to right. The wide separation between the columns, however, creates a barrier to the eye.

The "what's new" feature on the home page is similar to the previous effort. The question is whether it will continue to display only new press releases and statements, which is useful. But what would be really useful would be to post a "what's new" listing whenever a change is made to the Web site, such as when a fresh transcript or meeting agenda is posted.

For inexplicable reasons, the upper right hand corner has links to "content," "footer" and "accessibility." "Content" really should be called "about." "Accessibility" does not need to occupy such prime real estate on the home page. As for "footer," who knows what that refers to.

We have no doubt that CIRM is interested in feedback on the design and how to make it more useful. Send your comments to info@cirm.ca.gov -- an email address that is now nearly "secret."

If you are interested in a PDF copy of the Web site marching orders from the Golden State's eService office, please send a message to djensen@californiastemcellreport.com. Sphere: Related Content

Saturday, June 16, 2007

New CIRM President in Two Weeks?

The California stem cell agency appears to have a new president waiting quietly in the wings.

The agency late Friday called a special meeting of its Oversight Committee for 7 a.m. June 26 to consider presidential candidates and compensation. The meeting will follow a session of the presidential search subcommittee at 5 p.m. June 25.

One of the issues in the presidential search has been compensation, largely driven by California's high housing costs, particularly in San Francisco.

Former CIRM President Zach Hall, who already lived in San Francisco, was paid $389,000 annually when he was hired. But it appears that salary will be boosted by the Oversight Committee.

At the time Hall was hired, some folks were not too happy about the level of executive compensation at the agency.

Announcement of a new president does not mean that he or she will soon be on the scene fulltime. Usually, such a person has to wind up affairs in a previous position, move, etc.

The meetings on June 25 and 26 will be conducted via conference calls. Access will be available at many locations throughout the state and in Australia, where one of the Oversight Committee members is visiting. The public can listen in and take part from those locations. The specific addresses can be found on the agendas.

The agenda for the June 26 meeting is not yet posted. Here is a link to the June 25 agenda, which is quite cryptic. Sphere: Related Content

Short Update on ESC Research Nationally

All the excitement of paint-drying is how the blog of the American Journal of Bioethics describes stem cell research action at the federal level.

Jim Fossett
, director of health and Medicaid studies at the Rockefeller Insitute, made the comment in a brief overview of what is up around the country, including the Golden State. An excerpt:
"California’s far from the only state that’s been active on the stem cell front this year. New York has more or less firm plans to spend some $600 million on stem cell research, and gossip has it that Governor Eliot Spitzer may introduce a proposal for a bond issue to support this research on a larger scale. Maryland has just awarded some $20 million in stem cell research grants, and the state legislature has just approved an FY2008 budget that appropriates some $23 million in research support. Connecticut is spending some $10 million per year on stem cell research. Massachusetts Governor Deval Patrick has just unveiled a major package of stem cell initiatives that would spend some $1.25 billion in state and private funds, outlined here."
Sphere: Related Content

More from IPBiz

IPBiz, the intellectual property blog operated by patent attorney Lawrence Ebert, has more to say on WARF, the California stem cell agency grant to CHA RMI and the failings of this blog, the California Stem Cell Report. You can read it all here. Sphere: Related Content

Friday, June 15, 2007

Lawyer Critical of California Stem Cell Report

Patent attorney Lawrence Ebert covers considerable ground this morning in a post called "National Academy of Sciences Attacked."

Ebert has written extensively on the WARF stem cell patent issues, disputing the assertions of critics challenging the WARF patent.

Today Ebert takes on this blog(the California Stem Cell Report), the Los Angeles Times and the San Diego Union-Tribune. A sample:
"Although the californiastemcellreport is ripping into NAS, the stemcellreport is rather silent on the mediocre reporting of the San Diego Union-Tribune on past attempts of California stem cell workers to obtain broad patent coverage on embryonic stem cells and on the superficial reporting of the Los Angeles Times on the Cha duplicate publication matter."
Ebert is deeply concerned about the legal issues concerning the patents. Our perspective is somewhat broader. While certain actions -- either in the world of patents or politics -- may be legal, they are not necessarily in the best interests of society, science or business. An extreme non-science example: Racial segregation used to be the law of the land in many areas of the United States.

Ebert appears to be well-schooled in patent law. Others equally well-schooled differ with him. We are inclined to favor those who are on the side of open science rather than those who seek to lock down every piece of loose intellectual property they can find. But that is a value judgement -- not law.

Nonetheless we encourage you to read Ebert's comments. He may be right. Sphere: Related Content

Thursday, June 14, 2007

The National Academy of Sciences: Feeding the Anti-Science Movement

The National Academy of Sciences has not distinguished itself with its response to the flap about barring the public from a meeting of public officials discussing interstate cooperation on billions of dollars in stem cell research financed with taxpayer funds.

We have not heard from the academy concerning the hooha but it finally responded to a letter of protest from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., who was ousted from the meeting in California last month. An academy official said the meeting was "private" although state officials were there at taxpayer expense discussing issues of public import in at least 10 states.

The letter from the NAS demonstrated a fundamental failure to grasp that secrecy on this subject is not in the best interests of the public or of the academy. Closing the door only generates suspicion and distrust and unnecessarily feeds the anti-science movement in this country.

Here is the text of NAS letter to Simpson and Simpson's response. First the letter of E. William Colglazier, executive officer of the NAS.
"I am responding to your letter of May 24 regarding the meeting at the Beckman Center in Irvine, California, on May 23 and 24 involving representatives of states involved in stem cell research. That meeting was an invitation-only planning session, which we were requested to convene, to discuss the potential interest of states regarding sharing information and improving coordination in the future. As the states decide how and when to move forward with information sharing and interstate coordination activities, I expect that there will be ample opportunities for public involvement."
Simpson's reply:
"Thank you for your June 13 response to my letter of May 24 expressing concerns about the private meeting of representatives of state stem cell research programs. You give me great comfort.

"Any doubts that I had about earlier characterization of the National Academy of Sciences as a paternalistic organization that believes the public cannot be trusted to understand science have been put to rest.

"Moreover, your suggestion that 'there will be ample opportunities for public involvement' in the future misses the point.

"The meeting in Irvine, CA, was of representatives of publicly funded stem cell research programs talking about public policy. The public should have been involved from the beginning, not at some vague future date at the convenience of the scientific bureaucracy.

"You should apologize for closing the meeting, and any future sessions of this group must be open to the public.

"The National Academy of Sciences' paternalistic approach only serves to undercut public confidence in any policies that may emerge from the interstate meetings. This does not serve the interests of the states, the National Academy nor stem cell research."
As we mentioned earlier, public officials from any state should not attend any further closed-door meetings on this matter. No good reason exists for banning the public. All of the issues can and should be discussed in public. Airing differing views early is one good way to write intelligent policy and build public support.

(Editor's note: An earlier version of this incorrectly quoted Simpson's letter as saying xxxx at the convenience of the scientific democracy (instead of bureaucracy). Sphere: Related Content

Tuesday, June 12, 2007

Public Matters, Public Money Topic of "Secret" Agenda

For a look at what one might call the "secret" agenda discussed during last month's closed-door session promoting interstate cooperation on stem cell research, you can find the documents posted on the web site of the Foundation for Taxpayer and Consumer Rights.

The National Academy of Sciences barred the public from the California meeting. An academy official said the session was private despite the fact that it involved public officials, dealing with public matters and public money.

John M. Simpson, stem cell project director for the foundation, received the documents before he was ousted by the academy official.

Topics discussed at the Irvine, Ca., session included intellectual property (not a small matter for California taxpayers), reciprocity between states, model legislation and research oversight. All are clearly part of the public agenda on embryonic stem cell research.

Ironically, also on the table was a draft mission statement, calling for the nascent "Interstate Alliance for Stem Cell Research" to promote "efficient and responsible use of public funds." Ironic because private, closed door meetings discussing how to use billions of dollars in taxpayer funds can hardly be called responsible.

For more on this subject, see the "Fails Responsibility" below. Sphere: Related Content

Transcript Now Available on SB771

The transcript of the meeting of the CIRM Intellectual Property Task Force dealing with SB771 is now available online at this link. The meeting was the subject of the "looming compromise" item below. Sphere: Related Content

Monday, June 11, 2007

National Academy of Sciences Fails Public Responsibility Test on State Stem Cell Issues

"Absolutely outrageous," "outmoded, elitist" complete with a "public-can’t-understand-science attitude" -- the National Academy of Sciences.

That is the description of the group as provided by John M. Simpson, the normally mild-mannered stem cell project director of the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., who has trekked north and south through California for a couple of years following and influencing California's $3 billion stem cell research effort.

Simpson was justifiably irked when he was barred last month from a NAS-supported meeting of public officials by Fran Sharples, life sciences director of the the NAS. Simpson had been invited to the first meeting of the group in Connecticut, but could not attend. When he showed up for a follow-up meeting in Irvine, Ca., Sharples said that it was private and he could not attend despite having being invited earlier.

But invitation or not, Simpson's point is that this is public business – not some private, secret affair.

Attending the session in May were representatives of 10 state public stem cell research programs from across the nation. The two-day session was aimed at creating the Interstate Alliance for Stem Cell Research. Among its goals would be "creating opportunities for collaboration among different states' stem cell programs and harmonizing regulations."

All of which is of great importance to state research efforts, which are funded by public money – not NAS funds – and which are generally required to operate in public under open meeting and open records laws.

Simpson wrote a letter of protest to Ralph J. Cicerone and E. William Colgazier, respectively president and executive officer of the academy, concerning its egregious behavior.

Simpson said,
"When the public is shut out of the process, we can only wonder what is being done behind closed doors. For instance, in the quest to 'harmonize' regulations between states will only the lowest common denominator in regulations be adopted?"
And again this month, Simpson said,
"We completely support efforts to foster co-operation among the states, but the notion that the National Academy of Sciences would close such a meeting to the public is absolutely outrageous. It is the outmoded, elitist, public-can’t-understand-science attitude, that ultimately undermines the public’s willingness to fund research. It’s time NAS moved into the 21st century. Their current behavior is exactly what prompts the know-nothing attitude of our president and his right-wing base."
The National Academy of Sciences is a nonprofit organization created by Congress. The intent of Congress was to create an organization that serves the public, albeit indirectly. The Federal Advisory Committee Act which deals with the NAS seems intended to open rather close the academy's proceedings. The action last month in Irvine barring the public from an important stem cell meeting violates the intent if not the letter of that law.

We have asked the NAS for a response or justification (including information on its funding sources) but it has not responded. Nor has it yet responded to Simpson's letter of 18 days ago. We will carry the group's statement verbatim when we receive it.

For now, however, the academy should be embarrassed by its highhanded conduct. Moreover, closing the doors on the public is harmful to the academy and defeats its purpose of advancing the cause of science. Instead the NAS is breeding suspicion and distrust.

The California stem cell agency, as well as those in the other states, should boycott any further meetings of the NAS on the subject of interstate cooperation unless it is willing to open the sessions. Sphere: Related Content

Looming Compromise on CIRM Legislation?

The California stem cell agency seems to be heading towards something of a partial compromise concerning legislation aimed at ensuring a fair return to the state on its $3 billion stem cell research effort.

The bill – SB771 –is now in the Assembly after passing the Senate on a whopping 38-0 vote. Sen. Sheila Kuehl, D-Santa Monica, chair of the Health Committee, and Sen. George Runner of Antelope Valley, one of the Republican leaders, are co-authors.

The legislation came up for discussion at a meeting late last month of CIRM's Intellectual Property Task Force. Duane Roth, a San Diego pharmaceutical company executive and member of the CIRM Oversight Committee, suggested a modification in sharing net license revenues from CIRM-funded inventions.

According to one Senate analysis:
"The proposed commercial regulations by CIRM require that 17 percent of licensing fees in excess of $500,000 be paid to the state, that three times the grant amount be paid for patented products supported by CIRM, and that the state be entitled to 1% of all revenues in excess of $500,000 for the life of a patent if CIRM provided support over $5 million.

This bill would, instead, require the CIRM regulations provide the state 25% of net licensing revenues resulting from supported research; grant exclusive licenses to firms intending to provide access to resulting therapies to uninsured Californians."
Roth proposed changing CIRM's commercial regulations, which are still being drafted, to 25 percent as in the bill instead of the previous 17.

Roth told the IP task force, according to the transcript:
"I don't think it matters that much to industry that's going to take CIRM money, have an invention, and then license to a third party, whether they keep 83 percent of the revenue or 75 percent. And the reason I'm bringing it up is...it's difficult to explain. It can be explained, but it's difficult. And I think the rationale behind it is the hardest part of the explanation."
Roth also said a change would indicate that CIRM is willing to meet Kuehl halfway on the bill.
A quorum was not present at the IP Task Force meeting, so the group did not take an official vote. But no opposition to the change was expressed. An official policy change would require a vote of the full Oversight Committee, which opposes SB771.

The IP meeting occurred before the measure passed the Senate on the 38-0 vote.

Also discussed at the Task Force meeting was another issue related to SB 771 – affordable access. CIRM has moved away from language linking access to Medicaid prices.

Scott Tocher, a CIRM attorney, outlined problems with the Medicaid price and the rationale for linking access to the California RX Discount program, whose regulations are being formulated by the California Department of Health Services.

Kuehl's bill would require licensees of CIRM-funded therapies to provide access at Medicaid prices to patients whose care is provided with public funds.

The Task Force transcript is expected to available online soon on the CIRM web site. Sphere: Related Content

More on Cha Retraction

Both the Los Angeles Times and The Scientist magazine have reported on the retraction involving Alan DeCherney and Kwang-Yul Cha, which we carried on June 7.

Here are the links to the story in the Times by William Heisel and the piece in Scientist byAndrea Gawrylewski. Sphere: Related Content

Friday, June 08, 2007

A Commercial Perspective on Resetting Stem Cell Clocks

Andrew Pollack of the New York Times wrote a piece Thursday that contained some interesting comments from California folks on mice and resetting their stem cell clocks.

Some excerpts:
"'Once you muck around with the genome, all bets are off,' said Dr. Thomas B. Okarma, chief executive of Geron, a company trying to develop medical treatments from human embryonic stem cells. Dr. Okarma said getting approval from the Food and Drug Administration would become 'enormously more complicated.'"
Pollack continued:
"Joydeep Goswami, vice president for stem cells and regenerative medicine at Invitrogen, a company that sells tools for stem cell research, said the new technique could get more companies interested in stem cells.

"Not only does it eliminate the ethical issues, he said, but it also might provide a way around stem cell patents held by the University of Wisconsin that some scientists and corporate executives say have hindered work in the field.

"Still, an even bigger hurdle for investors has been the uncertainty of whether stem cells can be turned into lucrative medical treatments. Some experts say this might take a decade or more, too long for many investors to wait."
More from Pollack:
"Dr. Okarma of Geron pointed out that after mouse embryonic cells were first isolated, it took about 18 years before human embryonic cells were similarly derived. Geron, based in Menlo Park, Calif., paid for the work with human cells at the University of Wisconsin and has exclusive commercial rights to certain types of tissues created from human embryonic stem cells.

"Dr. Okarma also said it might not be desirable to use skin cells as a starting material because they might have been genetically mutated by exposure to ultraviolet radiation."
Pollack continued:
"William M. Caldwell IV, chief executive of Advanced Cell Technology, said his company had not been able to obtain enough human eggs needed for therapeutic cloning. So the new approach, Mr. Caldwell said, is 'a technology that everyone should take a hard look at.'"
Sphere: Related Content

Thursday, June 07, 2007

Fertility and Sterility Editor Retracts Comments About Cha

The editor of the Fertility and Sterility Journal has retracted and apologized for his remarks alleging plagiarism and perjury linked to Kwang-Yul Cha, a South Korean scientist whose organization includes a Los Angeles lab that was approved for a $2.6 million California stem cell grant.

The May 31 letter was written by Alan DeCherney to Cha following articles in the Los Angeles Times and The Scientist concerning DeCherney's allegations. The charges received additional attention after CHA RMI in Los Angeles successfully competed for the CIRM grant.

Following approval of the research funds, two organizations that monitor CIRM said the news reports raised troubling questions.

Here is the text of the DeCherney letter, written on the letterhead of the American Society for Reproductive Medicine. The letter was supplied to the California Stem Cell Report by a representative of the Cha organization.
"Dear Dr. Cha,

"I am writing to apologize for the distress and any reputational damage my statements to The Scientist (February 20, 2007) and the Los Angeles Times (February 18, 2007) have caused you and your organization. Considering the facts of the matter, I consider my references to 'plagiarism' and 'perjury' to be inaccurate and regrettable. I hereby retract them and give you permission to forward this letter to the authors of both articles, and to their editors, for their information. You may use this letter in full form publicly in any way that you wish.

"I regret that I did not contact you or the other authors earlier to determine the facts of the matter, since it was brought to my attention more than a year ago. Please accept my apology for my hasty remarks to the reporters.

"After checking our records, I acknowledge that Dr. Jeong-Hwan Kim's name was included as an author when the manuscript was originally submitted, though I am not aware of the circumstances that ultimately led to his exclusion from the list of authors. I also acknowledge the fact that two formal requests were made in 2006 (after publication of the article in F&S) asking that Dr. Kim be added to the article as an author and that I did not respond to either of them.

"I want to emphasize that we found no scientific fault with your paper: "Quantification of mitochondrial DNA using real-time polymerase chain reaction in patients with premature ovarian failure," published in Sterility and Fertility. In accordance with the press release issued by the Fertility & Sterility board in April, we determined that you were not responsible for the dual publication. While the Board did not consider the issue of authorship, I have no reason to believe that you should not receive credit as first author. This would be consistent with the customary practice in the United State of the Corresponding Author providing the appropriate authorship credits.

"We hope that this will not discourage you and your scientific colleagues from submitting original research articles to Fertility and Sterility in the future.

"Sincerely,

Alan DeCherney, MD"
Funding of all the grants approved in March, including CHA RMI, has not yet begun. CIRM is reviewing them all as part of its normal practice to assure that each grantee can comply with the terms of the grant.

If you are interested in a PDF copy of the DeCherney letter, please send a request to djensen@californiastemcellreport.com. If you would like to read more on this subject, we have posted a number of items in March and April. You can find by using the search term CHA. Sphere: Related Content