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.

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.

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.

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.)

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.

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.

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."

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."

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."

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."

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.

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.

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.

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.

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.

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.

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.

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."

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.

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.

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).

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.

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.

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.

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.

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.

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.'"

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.

Turning Back Time on Mice Stem Cells: Implications for California

Does the news that scientists have found a way to reset the clock on adult mice stem cells mean that the California stem cell institute should fold its $3 billion tent and slink off into the night?

A case can be made that announcement reduces the imperative behind CIRM, formed to fund research into human embryonic stem cells because of President Bush's restrictions on federal financing in that area.

But scientists and CIRM are having none of it. Indeed, the Japanese scientist, Shinya Yamanaka of Kyoto University, who made the initial discovery in 2006 predicts that duplicating the procedure in humans would be "more demanding" than the mouse work.

At least three California newspapers visited the subject today, reporting that CIRM and researchers say the development, if ultimately successful, will take years to prove useful in humans and offers just another avenue for potential CIRM funding.

Carl Hall of the San Francisco Chronicle wrote:

"Arlene Chiu, interim chief scientific officer at the California Institute for Regenerative Medicine, the agency in charge of the state's $3 billion stem cell program, said the new work shows a path around a major bottleneck -- the shortage of fresh human eggs available for research.

"'We are interested in new ways of generating pluripotent stem cells,' she said. 'The important thing to us is the product, not the process. But the rarity of eggs is definitely a challenge.'

"Ethical rules in California and other states forbid paying women who undergo the sometimes risky egg-extraction procedures. Harvard's Kevin Eggan, a senior scientist involved in the new experiments, said Wednesday that he and his colleagues have been unable to find even a single egg donor after a year of looking.

"Ethics aside, Eggan said the real reasons his lab pursued an alternative to egg donation 'are really scientific and logistical in nature.' Researchers, he said, are seeking a way to use nonviable embryos.

"In fertility clinics, somewhere between 3 and 10 percent of women's eggs are improperly fertilized, typically with an extra sperm getting inside. That translates into about 15,000 to 50,000 nonviable, one-celled embryos, also known as zygotes."

Steve Johnson of the San Jose Mercury News quoted Christopher Thomas Scott, executive director of Stanford's Program on Stem Cells in Society as saying much more work needs to be done before the techniques can be used in humans:

"To kind of claim that one study is going to do the trick isn't the way that science works."

Johnson also reported that Arnold Kriegstein of UC San Francisco

"... noted that much of the embryonic stem-cell research going on in California involves examining how to turn cells into treatments. Consequently, he said, the knowledge gained from that will be useful no matter which types of cells - embryonic or reprogrammed - ultimately are determined to be best."

Terri Somers of the San Diego Union-Tribune had this on the impact of the latest research announcement.

"'It's really remarkable work . . . and as big as Dolly (the cloned sheep) in lots of ways,” said Alan Robbins, chief technology officer at Novocell, a San Diego-based stem cell company. 'If it can be translated into humans, then it opens up the way for designer embryonic stem cells.'"

Gautam Naik of the Wall Street Journal also put together an excellent piece with a great deal on the background and implications of the research.

TV Stem Cell Coverage, Reijo Pera and Stanford

Television rarely covers California stem cell issues yet the medium is one of the most important sources of news for the public.

That is one reason why we like to point out TV coverage when it does occur, as in the case of a report by Erik Rosales on San Francisco station KGO.

He put together a roughly two-minute piece Tuesday, built around the lab grants approved by CIRM's Oversight Committee. Rosales filmed folks at Stanford, featuring Renee Reijo Pera, director of human stem cell research at the school.

You can see the entire piece here, complete with an ad that provides the full commercial TV experience. Click on the image of the hand in the latex glove to start the video.

On the subject of news coverage of Tuesday's grant approval, we should note that it received no TV coverage in Los Angeles as far as we can tell. CIRM called a news conference for noon Tuesday in Los Angeles but no reporters turned up. As we reported earlier, only one main stream media reporter was present for the session of the Oversight Committee, Terri Somers of the San Diego Union-Tribune.

Los Angeles is a tough news town, and it usually takes more than handing out $50 million to generate coverage. Perhaps if CIRM had shot the money out of a cannon in the Rose Bowl and had researchers run for the dough....

CIRM Legislation Easily Clears the California Senate

The California State Senate today overwhelmingly passed legislation aimed at ensuring a return to the state on its $6 billion stem cell research investment as well as providing affordable access to therapies that may be developed.

The bill, SB771, cleared the Senate on a 38-0 vote. It now goes to the Assembly, where it also requires a three-fifth vote for approval, not to mention passage through at least two committees.

The measure is authored by Sen. Sheila Kuehl, D-Santa Monica, chair of the Senate Health Committee, and Sen. George Runner of Antelope Valley, chair of the Senate Republican Caucus.

The size of the vote in favor of the bill seems to indicate that the opposition to the bill by the California stem cell institute and the state's biotech industry has not been effective so far. But the vote also could reflect the strength of its authors in the Senate, where their colleagues might be reluctant to offend. The Assembly could be a different matter.

We have not yet seen any news stories on the Senate vote. Those may not be available until Thursday.

(Regarding the $6 billion figure in the first paragraph, that represents the total investment by the state: $3 billion for research and $3 billion in interests for state bonds.)

CIRM Lab Grants: News Coverage Around California and China

Here are links to additional news stories on the $50 million in lab grants approved Tuesday by the California stem cell agency.

Lisa Krieger, San Jose Mercury News, story also appeared in Woodland Daily Demorat, Contra Costa Times and San Mateo County Times, excerpt:

"'We're hoping our facility will be a dynamic place for people to learn and share ideas about embryonic stem-cell research,' said Renee Reijo Pera, professor of obstetrics and gynecology and director of human stem-cell research at Stanford. UCSF's Arnold Kriegstein, director of the university's stem-cell program, said: 'It's terrific. We'll be able to double the size of our research facilities.'"

Xinhua news service, People's Daily, China, excerpt:

"'Once again, our state is leading the nation in stem cell research,' (Gov. Arnold) Schwarzenegger said. 'With the grants announced today, California has issued more than 200 million dollars in grants to pursue potential therapies and cures for debilitating diseases."

Gary Robbins, Orange County Register, excerpt:

"UC Irvine has collected an additional $3.9 million for the study of human embryonic stem cells, raising its backing from the state to about $17.5 million and making the campus among the most heavily funded in the world in this nascent area of biomedical research."

David Raclin, Riverside Press Enterprise, excerpt:

"The grant is UCR's third of the year from the California Institute for Regenerative Medicine. Two UCR professors were awarded a combined $1.1 million in February."

Richard Halstead, Marin Independent Journal, excerpt:

"(Jim) Kovach (president of the Buck Institute) said it is too early to say if the Buck Institute is likely to aggressively pursue additional grants from the California Institute. Kovach said the Buck Institute might need to dedicate an entire building - 60,000 square feet or more - to succeed in that endeavor."

San Francisco Business Times, excerpt:

"The new shared research laboratory (at the Buck Insititute)will consist of 36 lab benches and spaces for equipment and procedures commonly used in stem cell research. The training facility will include a multi-purpose room and office space for weeklong training courses that will take place four times each year.

Shanna McCord, Santa Cruz Sentinel, excerpt:

"With the grant money, UCSC plans to build a central facility on campus dedicated to human embryonic stem cell research, train scientists and provide new opportunities for faculty, said Ann Pace, assistant director for UCSC's Center for Biomolecular Science and Engineering. Renovation of the Sinsheimer Building on Science Hill is part of the plan, including the development of laboratory suites and training rooms, Pace said."

Jeanmarie Todd, Bloomberg, excerpt:

"The grants are 'a prelude to the $222 million in major facility grants'' the institute will consider 'early next year,' according to an e-mailed statement today(6-5-07)."

The Los Angeles Times, The Sacramento Bee and Davis Enterprise do not seem to have carried stories today. Links to the San Francisco Chronicle and San Diego Union-Tribune were carried Tuesday(see below).

Correction

The "Gives Away $50 Million" item on June 5, 2007, incorrectly stated that of the institutions represented on the Oversight Committee, only one did not receive a lab grant. Actually, there were two, Cedars-Sinai in addition to the City of Hope. Our thanks to the person who called this to our attention.

Lab Grant News Coverage

Here are links to two stories today on the CIRM lab grants(see the item below): Terri Somers, San Diego Union-Tribune, and Carl Hall, San Francisco Chronicle. Hall was not present at the Los Angeles meeting.

Stanford Fires First

Stanford publicist Amy Adams was the first out this afternoon among recipient institutions with a press release on the $4.1 million grant to her Palo Alto institution. You can find her item here.

CIRM Gives Away $50 Million for Stem Cell Labs

"We have to be as generous as we can," said Duane Roth, a member of the Oversight Committee that controls the $3 billion California state stem cell research effort.

The comment from the CEO of Alliance Pharmaceutical Corp. came shortly before the board approved its first-ever laboratory grants – some $50 million to 17 institutions. Twenty-two applied.

Roth echoed comments from others on the 29-member committee. Claire Pomeroy, dean of the UC Davis Medical School, said, "We're building an array of services across the state."

A handful of the committee members raised questions about whether the panel should be more or less generous than reviewers who made recommendations to the full committee. David Baltimore, former president of Caltech, said, "When a vote has been taken, it sets a very high bar to change that recommendation."

He said the Oversight group should exercise lest it undercut the grant review process.

CIRM's press release said:

"These facilities are scheduled to be complete and available to researchers within six months to two years of the grant awards.

"The grants will fund dedicated laboratory space for the culture of human embryonic stem cells (hESCs), particularly those that fall outside federal guidelines. (Current federal policy prohibits research involving hESCs isolated after August 2001 from being conducted in laboratories constructed with any federal funding.) CIRM’s grants will support the development of core laboratories to be used by multiple investigators that may be shared by multiple institutions, and provide an environment for scientific research on hESCs under CIRM’s medical and ethical standards."

It continued:

"The grants will provide funds for the design and renovation of laboratory space, equipment for the new research facilities, and operating expenses for three years. Six of the recipient institutions will receive additional funds to provide training courses for scientists and technical staff in the growth and maintenance of hESCs."

The release quoted stem cell Chairman Robert Klein as saying,

"'Today we passed the $200 million mark in funding for embryonic stem cell research. The grants approved today are a prelude to the $222 million in major facility grants we’ll consider early next year. It’s critically important that California provide a ‘safe harbor’ where scientists can work on new stem cell lines without endangering their institutions’ federal funding. It’s equally important that we help finance new facilities to house the growth of this emerging life sciences field. These grants establish a great collaborative model that leverages the intellectual capital of California’s leading scientific institutions for the benefit of all Californians.'"

Here are the recipient institutions: Salk Institute, $2.3 million; Buck Insitute, $4.1 milion including a stem cell techniques funding course; Scripps, $1.7 million; UC Davis, $2.8 million; UCLA, $2.9 million; UC Santa Cruz, $2.7 million; Children's Hospital Los Angeles, $2.8 million; UC Riverside, $2.9 million; Burnham Insitute, $3.8 million including course funding; Gladstone Institutes, $1.7 million; Stanford, $4.1 million including course funding; UC Berkeley, $2.1 million; UC Santa Barbara, $2.3 million; UC San Diego, $2.8 million; UC San Francisco, $3.9 million including course funding and USC $3.6 million including course funding.
 
UC campuses in Davis, Riverside, Santa Barbara and Santa Cruz as well as Scripps moved into funding positions after receiving "mixed" recommendations from the two initial review groups.

Fourteen representatives from the institutions applying for the grants sit on the Oversight Committee. All but one of those institutions, the City of Hope, received funding. Oversight Committee members are barred by law from voting on or participating in discussions involving grants to their institutions.

Only one mainstream media reporter was present for the today's session, Terri Somers, of the San Diego Union-Tribune.

Correction

The "CIRM Tonight" item below omitted UCLA as one of the institutions that was recommended for funding by both groups. Thanks to the gent from UCLA who pointed this out.

Gaucho Scientists Likely to Win Stem Cell Grant

UC Santa Barbara appears to be on its way to winning a $1.8 million stem cell lab grant from the California stem cell institute.

That was the biggest development out of Monday night's meeting of CIRM's Oversight Committee, which met at the Luxe Hotel on Sunset Boulevard in Los Angeles.

The committee did not have a quorum, so it could not take official action. But the group approved a recommendation to move the UCSB grant to the top tier of grants expected to be approved.

The application had received low marks from the facilities working group but was ranked high for its research plans. The low marks were mainly related to construction costs in Santa Barbara, which is one of the more expensive areas in which to build in California.

No Gauchos, as UCSB denizens are known, appeared before the committee. Nor did representatives of any of the other lower ranking proposals make a last minute pitch to save their plans for stem cell labs.

Perhaps they will appear Tuesday morning, but we suspect they are not fully aware that they can appear before the Oversight Committee to explain why their proposals are worthy of funding.

CIRM Tonight: Juggling $48 Million in Lab Grants

The California stem cell institute meets this evening to hand out as much as $48.5 million for laboratories for embryonic stem cell research.

A news conference is scheduled for noon on Tuesday to announce CIRM's actions, but it is likely to be mostly settled by 9 p.m. PDT or so tonight. We will carry a report following the end of the meeting.

The ultimate decision on the grants is made by the Oversight Committee of the institute, which is the group meeting this evening. But it has been loathe to make significant changes in grant recommendations by its working groups.

The 22 applications were reviewed by two CIRM working groups –- one that focused on facilities and one that was more oriented towards the research.

Recommended for funding by both the facilities and grants working groups are grants to the Salk Institute, Buck Institute, Burnham Institute, Gladstone Institute, Stanford, UC Berkeley, UC Irvine, UC San Diego, UC San Francisco and USC.

No funding was recommended on applications from UC Riverside and the Palo Alto Institute of Medicine by both the facilities and grants groups.

The facilities group recommended no funding for UC Santa Barbara, but the grants group gave it a favorable recommendation.

Negative recommendations were made by the grants group on applications from Scripps, Cedars-Sinai, UC Davis, UC Santa Cruz, Beckman Research Institute (City of Hope), Blood Systems Research Institute (San Francisco) and California Pacific Medical Center Research Insitute (San Francisco). But facilities group gave these insitutions a favorable recommendation.

Copies of the applications, rankings and much, much more can be found here.

CIRM's Research Standards -- A Look at Their Principles and Reasoning

If you looking for a good overview of the rationale and background for the research standards enacted by the California stem cell agency, check out an article on PLoS Medicine by three men deeply involved in the subject.

The piece is called "Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine's Medical and Ethical Standards." It was written by Geoffrey P. Lomax, Zach W. Hall and Bernard Lo.

Hall is the former president of CIRM. Lomax deals with the institute's research standards development. Lo is with UC San Francisco, where he deals with medical ethics. He also serves as co-chair of CIRM's standards working group.

The ESC regulations developed by CIRM broke new ground in some areas and were the most refined in the nation at the time they were promulgated.

The article notes:

"Because other states and jurisdictions may also be developing standards for hESC research, consideration of the principles that guided the CIRM efforts and the innovative measures that it enacted may be useful to others."

One of the excellent attributes of the piece is that it is not hidden behind a private Web site that costs hundreds of dollars to access. It can be found gratis at the www.plosmedicine.org.

Fresh Comments

Lawrence Ebert has posted a comment on the $220 million item. Don Reed has posted a comment on Canadian-California item. Thanks, Don, it is nice to be back in the Old Country.

The $220 Million Lab Giveaway and Its Rules

Scientific laundromats, silos and collaboration benches.-- all were part of the discussion Thursday as the California stem cell institute began developing its criteria for giving away $220 million to build major research facilities.

The meeting was unusually well attended, with the audience easily exceeding the size of those usually at CIRM's Oversight Committee meetings. The actual numbers, however, were less impressive – something slightly over 30.

They were there because they represented universities and others hoping to win multimillion dollar grants to build new science complexes. USC(at least six representatives)UC San Francisco (at least two), Stanford(at least two), Children's Hospital of Oakland(one), UC Berkeley(two), UC Davis (one), UC Irvine (one) all were on hand.

The CIRM Facilities Working Group, which makes recommendations on lab grants, heard some interesting suggestions during the presentations and questions following.

Robert Klein, chairman of CIRM, several times said he expected some applicants to match the grant amount 100 percent, well exceeding a possible nominal match requirement of only about 20 percent. Also surfacing during the discussion was the suggestion that applicants who could line up major contributions – in kind or cash -- from industry might also be more favorably regarded. Other possible industry linkages could be important as well.

Some of the additional questions surfacing directly or indirectly: Is there going to be an effort to spread the grants around the state? How can smaller institutions compete successfully? Will there be more than one round of grant applications?

Irv Weissman, Stanford's eminent stem cell researcher, told the group, "You will be beset by all sorts of political and geographic forces."

"People will try to fool you," he said.

Weissman and others urged an emphasis on excellence. He said the track record of the institutions and their scientists is the best way to assure that.

Jeff Bluestone, director of the UC San Francisco Diabetes Center, also emphasized excellence. He and Weissman additionally spoke of the need to prevent scientists from becoming isolated in "silos" in the proposed labs.

"Successful buildings are ones that have people bumping into each other," Bluestone said.

At one point, CIRM Oversight Committee member Janet Wright used the expression "scientific laundromats" to describe space that can allow for informal research exchanges.

Weissman offered up collaboration benches as one way of bringing in researchers from locations that do not have facilities that match those of major institutions.

Jeff Sheehy, a CIRM Oversight Committee member, said he was interested in providing for opportunities for many institutions.

"Everybody should get a fair shot at attempting to do stem cell research in California," he said.

Thursday's hearing in San Francisco was the first of four. The next will be Monday in Los Angeles, the third June 11 in Sacramento and the fourth in San Diego June 19. You can find more information here and here.

Grant applications are expected to be solicited this August with grants awarded early next year.

Needless to say, it would behoove any institution that expects to seek building grants to attend and participate in these meetings. They offer an opportunity to shape the criteria but also can provide insight into the thinking of some of the players who will be making decisions on who receives the money.

CIRM Legislation Now on Senate Floor

Legislation to ensure a fair return to California from products developed as the result of state-funded stem cell research has moved to the floor of the state Senate, where it faces a major challenge for passage.

The bill, which is also aimed at ensuring affordable access to state-funded stem cell cures, must gain a super, super-majority vote to win approval in the Senate. The requirement for a 70 percent vote was written into the state Constitution in Prop. 71 by stem cell proponents who wanted to make it difficult for elected officials to fiddle with the $3 billion research effort.


The bill, SB771, cleared the Senate Appropriations Committee on Thursday after the Democratic Senate leadership approved its removal from a "suspense" file.

It is not known when the measure by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley, will come up for a vote in the Senate.

The Canadian-California Stem Cell Treaty

California Gov. Arnold Schwarzenegger did not exactly blow the dome off the Capitol -- newswise -- with his stem cell announcement in Canada yesterday.

Coverage was minimal. Perhaps the most details can be found on the governor's web site. California stem cell Chairman Robert Klein, who traveled to Canada as part of the governor's party, is also featured there with a video blog on stem cell matters.

Some excerpts from the governor's statement:

"(Ontario Premier)Premier McGuinty announced the formation of a new Cancer Stem Cell Consortium that will bring together the best minds and resources in California and Canada to fight cancer through stem cell research.

"This project was initiated by the stem cell and regenerative medicine working group of the Canada-California Strategic Innovation Partnership, a unique collaboration between California and Canada stakeholders from academia, the private sector and government."

"The Ontario Institute of Cancer Research will donate the first $30 million (Canadian) to fund the Consortium, benefiting both Canadian and Californian researchers."

"UC Berkeley's Stem Cell Center and Canada's International Regulome Consortium will coordinate research and take advantage of each institution's expertise."

The CIRM Budget and Burger King

The California stem cell agency plans to nearly double its staff during the next 12 months or so.

That means it will grow from tiny to not-so-tiny. In other words, from 24 workers to 41.

The additions are much needed. Beleaguered might be too strong a term to apply to the staff, but it probably was appropriate on some days during the last two years.

The additions are part of the budget approved earlier this week by CIRM's Governance Committee. The spending plan totals about $8 million for administrative functions, up from about $7.3 million for the current fiscal year, which ends June 30. The full Oversight Committee is expected to approve the proposal next week in Los Angeles.

CIRM is already seeking applications for the following positions: president, associate legal counsel, grants management officer, grants management specialist, grants technical assistant and scientific program and scientific review officers.

The agency will also see a substantial decrease in costs related to the now finally finished litigation, but CIRM will add $200,000 for legal work related to intellectual property issues.

Lest you fear that CIRM is on a path of rampant bureaucratic growth, Prop. 71 capped the number of employees at 50 to administer the $3 billion research effort. We would have to check, but it is probably fewer than it takes to run a Burger King.

CIRM Legislation: A Cash Cow or Bum Steer?

Legislation to ensure that California garners a decent return on its $6 billion investment in embryonic stem cell research has hit a roadblock and faces a critical hearing on Thursday.

The measure is SB771 by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley. Kuehl is chair of the Senate Health Committee and Runner is the No. 2 GOP leader in the Senate.

The bill has been shunted into a "suspense" file, along with many others, because the chair of the Senate Appropriations Committee, Tom Torlakson, D-Concord, is uncertain whether the measure would generate more revenue than would the regulations of the California stem cell agency itself.

If the measure is not removed from the suspense file, it will be placed on hold for this year and is not likely to be brought up again until January.

Discussions have been underway between Kuehl, Torlakson, Senate President Pro Tem Don Perata, D-Oakland , and Senate Majority Leader Gloria Romero, D- Los Angeles, about the fate of the bill. Kuehl and Runner are contending that it is impossible to make revenue comparisons between the bill and CIRM regulations because the regulations are not in final form. They also argue that arguments by the biotech industry concerning the adverse impact of the bill are highly speculative. Industry is also not fond of CIRM's rules.

Although the Kuehl bill is up for a nominal public vote, without a nod from the Senate leadership, the bill is not likely to be removed from the suspense file.

The staff of the Appropriations Committee has prepared an interesting analysis of SB771 that indicates that the measure would generate $56 million more for the state over a given period than would CIRM's regulations. Here are some excerpts:

"Based on a direct comparison of state revenues generated under SB 771 and under the CIRM regulations, SB 771 would produce more revenue than the CIRM regulations. In a ten year projection of a sample project modeled under three scenarios (a licensed invention, a low success royalty, and a high success royalty) with an $8 billion public investment, SB 771 would have produced $183.5 million compared to $127.7 million under the CIRM proposed regulations.

"The California Institute for Regenerative Medicine believes that the sample comparison above is misleading, that financial market forces, the interests of private research companies, and the unique nature of cellular therapies will produce disincentives which will substantially reduce the projected returns of 771."

The analysis said it reviewed economic studies of potential Prop. 71 returns although it did not cite them by name. It said the studies projected royalties to the state of between $160 million and $1.1 billion.

Earlier this month, an item appeared on the Internet that bears on the biotech industry position that anything that promises to inhibit returns on stem cell products (such as SB771) will discourage research. In an item called "What Price Innovation?," Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, wrote about industry arguments that Democratic national health care reform plans would choke medical research. Goozner said:

"Is there any evidence to suggest that the pace of significant medical breakthroughs can be associated with higher drug industry sales, profits, profit margins or, perhaps most significantly, R&D expenditures? Or, put another way, given the past decade's very high rates of sales growth, profit growth and R&D expenditure growth, how does one explain the steady downward decline (trend line; there is, of course, year-to-year variation) in the number of significant new drugs emerging from industry labs?"

Where's the Money?

Even today headlines talk about the stem cell "gold rush" in California. And it is years after the Prop. 71 campaign financed a study that seemed to promise as much as $1 billion to the state from state-backed stem cell research.

While the headlines may reflect a paucity of imagination on the part of headline writers, the dreams of buckets and buckets of stem cell cash still energize much of the dialogue concerning ESC research.

Jesse Reynolds, writing on the blog Biopolitical Times, recently revisited the subject of stem cell swag. The occasion for commentary was an article in Nature Biotechnology.

Reynolds, who works for the Center for Genetics and Society in Oakland, said what is remarkable about the piece is what's missing. He wrote:

"There’s no reference to the over-the-top -- yet widely-cited -- optimistic scenarios spun in an economic analysis that was widely touted, and funded, by the campaign to establish the (California) state program."

Reynolds noted that Stanford University professor of health research and policy Laurence Baker was a co-author of both the Prop. 71 campaign study and the Nature Biotechnology article, a fact that Reynolds said was not acknowledged in the magazine.

Reynolds said Baker furiously backpedaled from his campaign study. Reynolds quoted the Nature Biotechnology article as saying:

"[A]t this point predicting particular breakthroughs or economic benefits would amount to little more than speculation.... New stem cell therapies will not necessarily reduce [health care] spending; indeed they may drive spending up...Forecasting and even retrospectively assessing the success of Proposition 71's IP provisions will be extremely difficult."

The economic promises of stem cell research are as of much interest today as they were three years ago. Lawmakers are currently struggling to ensure that the state does, in fact, share in any profits. The biotech industry and CIRM are opposed to that legislation (SB771), authored by State Sen. Sheila Kuehl, D-Santa Monica, chair of the Senate Health Committee.

CIRM itself is in the midst of drawing up rules for revenue sharing involving future grants to California businesses. And elsewhere in the country, other states are launching stem cell research efforts, peddling the idea that it can funnel vast economic benefits into the state.

$30 Million California-Canadian Stem Cell Effort

California Gov. Arnold Schwarzenegger is off on a Canadian junket – privately funded – to promote stem cell research and wine, among other things.

According to some reports, he is scheduled to announce, along with Canadian counterparts, a $30 million stem cell research effort involving the Ontario Institute for Cancer Research and a cancer stem cell consortium in Ontario and California.

According to Robert Benzie of the Toronto Star:

"Schwarzenegger will disclose a new project between the University of California at Berkeley and the International Regulome Consortium, led by Michael Rudnicki, scientific director of Canada's Stem Cell Network and director of Ottawa's Sprott Centre for Stem Cell Research."

Beyond that, little was known about the project, although it appears to be an effort worked out between the researchers with the politicians weighing in at announcement time. Schwarzenegger's own Web site did not mention it on its home page this morning, which emphasized the wine aspects of the trip.

The governor's Canadian foray attracted some controversy because it was privately funded with none of the donors disclosed.

Kevin Yamamura wrote in The Sacramento Bee about the private nature of the trip, although he did include a list of some of the top corporate executives accompanying the governor.

Yamamura quoted Bob Stern, president of the Institute for Governmental Studies in Los Angeles, as saying,

"Why can't the state pay for it? It just looks wrong. Basically, you're having special interests pay for the trip. If taxpayers were paying, we'd know it's all California-taxpayer related."

We're Back!

The California Stem Cell Report will begin postings anew later today. We have spent much time in the Sea of Cortez and later on land in Mexico, preparing our salty home (a sailboat) for a bit of a rest during the next few months. It may not be much of a rest for us, however. Our major assignment will be to help care for some grandchildren for a bit. The sweet little things aside, you all can look forward to more exciting California stem cell tales beginning shortly.