Zipped Lips and CIRM's $263 Million

A glittering array of 29 scientists and executives rule California's prodigious $3 billion stem cell research effort. In many ways, they constitute some of the finest minds in the business and have even included Nobel Prize winners.

The thinking was that this elite panel of experts could bring their knowledge and wisdom to bear on the world's largest funding effort for human embryonic stem cell research. But this week, many of them will remain mum as $263 million worth of decisions are made.

The group is formally known as the Independent Citizens Oversight Committee(ICOC). More commonly, it would be described as a board of directors for the California Institute for Regenerative Medicine(CIRM). On Wednesday and Thursday, the committee will make critical, initial decisions on handing out $263 million for lab construction at the Golden State's finest research institutions. But only about one out of three of the directors will be able to vote on or even discuss some of the key issues in what is the largest round of grants ever made by CIRM.

The reason? They are associated with institutions that are seeking big chunks of the $263 million jackpot. In many cases they have conflicts of interests that CIRM's attorneys say make it illegal for them to vote or even participate in debate.

The impact goes well beyond silencing most of the board on some matters. It could also create a "quartet majority" in which the votes of four persons could be all that is needed to take some actions. Here is how it could happen, based on Prop. 71, which created CIRM, and an explanation last August from Tamar Pachter, CIRM general counsel.

The strange situation stems from the requirement that many of the Oversight Committee members -- by Prop. 71 decree -- must come from institutions that stand to benefit from CIRM's largess. They include deans of medical schools and executives at the University of California and other academic and research institutions. In fact, of the 12 lab grant applicants that CIRM has publicly identified, 11 have one or more members on the ICOC.

Last summer Pachter told board members that when the time comes to allocate the $263 million into various "buckets" – parcelled out, in other words, into such categories of competition such as "CIRM institutes" and "CIRM centers of exellence" – only about 10 members of the ICOC would not have conflicts of interest. She said,

"They are members who work for for-profits, patient advocates who are unaffiliated with institutions who will be applying for funds. That's it."

She did not spell out the ultimate implications. But Prop. 71 uses the number of ICOC members eligible to vote as the basis for a quorum, rather than the total number of persons on the ICOC. Prop. 71 also states that a quorum is 65 percent of those eligible to vote. Action can be taken by a majority of a quorum. So when 10 persons are eligible to vote, the quorum is seven. A majority would be only four – a fact not directly discussed at the August ICOC meeting.

But Oswald Steward(see photo), chairman of the Reeve, Irvine Research Center at UC Irvine, is one ICOC member who was disturbed by impact of what Pachter had to say. He acknowledged the importance of the conflict of interest rules. But he added,

"A lot of us are going to be left out...It's not just the case we can't vote; we also can't even participate in the discussions. And I think that narrows the field of expertise in a way that is unfortunate."

The ICOC ran afoul of this problem in December when it approved adding $35 million to the lab grant program. Only eight persons on the board were permitted to participate in the debate on that proposal.

The "quartet majority" problem also leads to some interesting speculation about whether it could come into play in connection with the attempt by Childrens Hospital Oakland Research Institute to overturn an unfavorable decision by the Grants Working Group on its lab grant application.

Could the Oakland hospital's bid be approved by only four members of the ICOC? One could argue that ICOC members associated with institutions with competing grants could not vote on Oakland's request because it could affect the amount of funding available for their institutions. But before the Oakland bid can come to a vote, a member of the ICOC has to make a motion to approve it. Then Oakland has to line up three other sympathetic board members.

But it certainly is something that folks in Oakland could be thinking about as well as at the University of California at Riverside and Cedars-Sinai in Los Angeles, two other rejected applicants.

FTCR: Rejected Lab Grant Applicants Should Appeal in Public

A CIRM watchdog organization today urged five institutions "rejected" for multimillion dollar state lab construction grants to appear publicly next week and make their case for funding from the California stem cell agency.

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights, said the review process for the $263 million lab grant program "has been flawed and smacks of favoritism that can only be cured by transparency." He said,

"CIRM management decided to reveal (last month) the 12 institutions that will be recommended for an invitation to seek funding so that they could use the information in year-end fundraising efforts. How is that fair to the five who were not anointed in secret by the closed scientific brotherhood?"

The California stem cell agency has declined to say whether any other lab grant applicants – besides Childrens Hospital Oakland Research Institute – are attempting to overturn negative decisions on their grant applications.

Ellen Rose, a spokeswoman for the agency, said,

"Appeals are allowable only if there is demonstrable evidence of a financial or scientific conflict of interest. Differences of scientific opinion among PIs and reviewers are not grounds for appeal. In the past, applicants who have raised questions about their grant applications or sought clarification, which is common in any granting exercise, have been informed of this policy. Thus far we have had no formal appeals to our grant-making process."

Simpson said CIRM's statement was "Orwellian double-speak." He said,

"I strongly urge representatives of all five rejected institutions to show up at next week's ICOC meeting and make their case in public directly to the board. It is, they claim, the decision making authority. What's happened so far were merely "recommendations.'"

By law, the Oversight Committee is the final authority on grant approval. It can accept or reject – for virtually any reason -- decisions by the working groups. That is one reason CIRM says it is not necessary for grant reviewers to publicly disclose their financial interests.

In response to queries from the California Stem Cell Report last month, two other institutions disclosed that their applications have been rejected. They are the University of California at Riverside and Cedars-Sinai in Los Angeles. However, they have not responded to queries on Thursday about whether they are asking Oversight Committee to reconsider the working group action.

The lab grant program is the first in which the names of applicants have been disclosed by CIRM, which previously said the names of all applicants were confidential even when the applicants themselves disclosed their own identity. The decision to assist the applicants with fundraising is important because CIRM will look more favorably during the two-step approval process on applicants with large matching funds.

The Oversight Committee is scheduled to take up the grants next Wednesday during the scientific portion of the approval process. Only those approved next week will move on to the next step.

Time for Business to Weigh in on CIRM Biotech Loan Plan

The California stem cell agency will hear next week from lenders and investors concerning its ambitious biotech loan progam, which is aimed at plugging a funding gap that has blocked development of stem cell therapies.

The Biotech Task Force is scheduled to meet on Wednesday in Burlingame, Ca., with a remote teleconference site at BIOCOM in San Diego. On tap is testimony from "capital providers and other experts." The task force has indicated it also plans to schedule a session with business and other potential applicants, which could include nonprofit research institutions.

According to California stem cell Chairman Robert Klein, the program could offer up as much as $750 million in loans to enterprises that cannot normally find funding from the usual providers. The program could get underway as early as this year, although the schedule is up for discussion next week.

Last month, Alex Philippidis, editor of the BioRegion News, interviewed Duane Roth, chairman of the task force, concerning the program. Here are some excerpts from the BioRegion piece. Roth told Philippidis,

"Think of the loan program — at least that’s the way I’m thinking about it, and the way our task force is thinking about it — as an evergreen fund. That means we can provide early-stage funding that is not available or has very limited availability from other sources [in order to] allow these products to move forward. Eventually those companies or those institutions that are sponsoring would repay the loans with interest, which would allow us to fund somebody else six, seven, eight years down the road."

Roth continued,

"If the program existed today, we’d be — and this is my opinion, and one I think is shared by the committee — that right now, the biggest gap in the funding is at the preclinical level, when somebody’s getting ready to say, ‘OK, I have preclinical evidence that this works. Now I have to do the toxicology and all the requirements for an investigational new drug application to the [US Food and Drug Administration].’ That is the toughest money to get. And that would be, if we put out [request for awards applications] today, that is likely what we would target."

More from Roth:

"But we don’t know where in the future the funding gaps are going to be, where the venture capitalists, or the angels, or Wall Street is not funding. And what we’re going to try to do is identify those gaps, and then put programs together to fill those gaps with funding from CIRM."

"It really would be a misnomer to only think that these loans would go to, quote, biotech companies. They may well go to other institutions that are also interested in advancing what we broadly categorize as products in this area."

"With this type of technology, it’s probable that there’s going to be a lot more interaction between the research institutes and what we classically think of as the companies that move these therapies forward. Some of them, at least, will be [stem] cell-based, so it’s not unlikely that many of the research institutes will get involved through pre-clinical, clinical, early clinical trials."

It is hard to overestimate how important it is for interested companies and institutions to weigh in early and often on this program. Sometimes industry seems to be missing from key CIRM proceedings. We recently discussed this issue with a representative of a company that pays more attention to CIRM than most. She said many of the companies in the stem cell business are tiny, very busy and cash-strapped. Thus it is difficult for them to monitor CIRM and offer comments, even though CIRM proceedings could be critical to their futures. Nonetheless, California stem cell companies should be monitoring CIRM more closely. Otherwise rules and regulations that may not be in their best interests could be promulgated.

The same advice goes for groups purporting to represent the "public." If they want to have an impact, they should be at the meetings and offer specific, constructive written recommendations on matters of interest. Only one organization, the Foundation for Taxpayer and Consumers Rights, seems to filling that role regularly at this point.

For more on the biotech loan program, search this blog using the search term "biotech loans." Or click on the label "biotech loans" just below this item.

Stem Cell PR, John Scully and Stanford

What a difference Arnold makes.

Stanford announced on Wednesday that investment banker John Scully was giving it $20 million for stem cell research, among other things. News coverage was modest, especially compared to the outpouring that resulted from an identical donation from Eli Broad to UCLA last year.

At that time, a Google search on the term "UCLA stem cell million broad" generated 244,000 hits by the afternoon following the announcement. In comparison a search at noon today on "Stanford stem cell million Scully" generated 11,500 hits.

The biggest single difference in terms of the coverage was the appearance of Gov. Arnold Schwarzenegger at an event at UCLA announcing the gift from Broad. It generated a wide range of stories including TV spots from the stem cell labs on the Westwood campus.

As we pointed out at the time, huge donations offer an opportunity to not only tout the institution and recognize the donor, but also to promote the field of human embryonic stem cell research.

When 55 percent of the public nationally says it has little or no knowledge of stem cell research, the field still needs major help. Donations provide a chance to tell a positive story – one that does not involve warnings of expensive therapies, dubious results or even research fraud much less conflicts of interest.

We should also note that the donation will probably give a boost to Stanford's bid for a multimillion dollar CIRM lab construction grant. One of the important criteria for the grants is a big fund match from the applicants.

Here is a link toe the Stanford news release on Scully (see photo) and a story in the San Jose Mercury News. The San Francisco Chronicle does not appear to have carried a story.

(An earlier version of this item incorrectly identified Scully as the former CEO of Apple.)

FTCR: Is CIRM 'Missing the Laboratory for the Test Tubes?'

The California stem cell agency is wrestling currently with a host of touchy issues in addition to the biggest round of grants in its history. Some of those matters surfaced last month and will surface again next week when the Oversight Committee also decides which institutions move on to the next round in the $263 million lab grant offering.

John M. Simpson, stem cell project director at the Foundation for Taxpayer and Consumers Rights, offers this commentary on some of those issues and how CIRM is approaching them.

"I mentioned in passing the other day that I think the ICOC folks sometimes miss the forest for the trees. (Maybe I should use a different metaphor, perhaps miss the laboratory for the test tubes?)

"Here's what I mean: Apparently everyone was worried at the last Governance Committee meeting about the bad image they might get if they use the word 'limousine' in the travel policy. But when a major restructuring of the institute's management structure is presented, it just sails through with nary a thought or comment.

"When Zach Hall was president he had seven direct reports. The new organizational chart shows Alan Trounson with only two, plus an administrative assistant. That is a substantial change in management philosophy and substance.

"I also expect the two managers reporting to him, the chief science officer and the chief operating office will command substantial salaries as both are to be either Ph.Ds or MDs. I tried to get at some of this in the December Governance Meeting when I ask on Page 30 of the transcript what their salaries and the salary of the director of finance and legal affairs will be.

"Re-reading Rich Murphy's response to my concern that the agency will be top heavy (Page 31), I have serious questions about Trounson's role. Here's what Murphy said:

"'I also want to be sure Alan has the guidance around him for him to be able not only to lead the institute, but for him to be the visionary leader of the institute. So he is going to have to keep his eyes on the field, he's going to have to be out on the road participating in meetings learning about new directions of the field. And when he comes back, one of the things he's going to have to do is to bounce off his ideas with high level leaders who are of his quality scientifically...'

"Just what is Trounson going to do day-to-day? Is he going to run the institute or is going to be spending more time on the road going from one conference to another around the world while the CSO and COO -- both with big salaries -- manage things?

"I'm not saying the new management structure is necessarily the wrong approach. My point is that it's a substantial departure from past practice and I'd have thought oversight committee members would have wanted to discuss it in detail in public.

"I would think the ICOC should be having a serious conversation about how this is going to work. I don't think anybody has focused on it, and it's much more important than whether someone takes an airport limo rather than a taxi."

Monkey Business, BioTime and the Search for Science

WARF and BioTime --California's BioTime Inc. has hooked up with WARF and signed a licensing agreement to use some of its patents on human embryonic stem cell research. The Emeryville firm said the WARF patents will allow it to manufacture and commercialize human embryonic stem cell-derived cell types and related products for scientists to use in research and in drug discovery. As part of that effort, the company plans to develop and commercialize a collection of research tools for stem cell research. Here is a link to a Wisconsin story on the subject, and here is a link to the company press release.

Monkeys and the American Psyche -- Scientific American says the reprogramming of adult rhesus monkey (see photo) stem cells into embryonic stem cells is one of the top 25 scientific stories of 2007, but that doesn't mean much to the public. The overwhelming majority of Americans has never heard of the research. So says the first poll taken since the announcement of the research results in November. According to the survey by the Virginia Commonwealth University, only 38 percent of those polled had heard of the reprogramming results. The implications for stem cell advocates? They have a long way to go before this stuff is entrenched in the American psyche.

Finding The Worthy – The topic of stem cell research grants to businesses came up recently in the Biopolitical Times, a blog produced by the Center for Genetics and Society. Jesse Reynolds wrote that the California stem cell agency should resist efforts by businesses to lower revenue-sharing requirements that might be linked to grants to the private sector. He also wrote:

"Although there is likely not enough current stem cell research capacity in California to warrant $300 million in grants per year, there's no effective mechanism to prevent as much money going out the door as possible, regardless of the research's quality. The CIRM's governing board is dominated by representatives of grant recipients - from the public, nonprofit, and corporate sectors alike."

Nearly three years, one anonymous writer from the world of academic science in California expressed a similar reservation about whether there is enough good stem cell science worthy of funding in California. More recently some on the Oversight Committee have expressed concern about maintaining the quality of the research that is being funded. However, this is not a subject likely to be discussed freely in public by folks at CIRM. To do so could appear to be casting doubts on the agency's mission.

NIH to ACT: Nyet!

A California-based firm, Advanced Cell Technology, says it has created human embryonic stem cells without harming the embryos from which they were derived.

The company said the results "have the potential to end the ethical debate surrounding the use of embryos to derive stem cells."

The NIH, however, says that isn't good enough. According to Rick Weiss in the Washington Post, the head of the NIH stem cell task force, Story Landis, said,

"(T)he only way to prove that the technique does not harm embryos would be to transfer many of them to women's wombs and see if the resulting babies were normal. But it would be unethical to do that experiment, she said, so the question cannot be answered."

That doesn't make Robert Lanza(see photo), the chief scientific officer at ACT, happy, Weiss wrote,

"That standard has Lanza fuming. By all scientifically recognized measures, he said, the embryos -- currently frozen in suspended animation because they were donated for research and not to make babies -- are normal, he said.

FTCR on Childrens Hospital Appeal: Fairness v. Secrecy

John M. Simpson, stem cell project director of the Foundation for Tazpayer and Consumers Rights, offered the following comment on the item below dealing with Childrens Hospital Oakland appeal of what amounts to a grant denial.

"CIRM management's now inconsistent penchant for secrecy coupled with news of the Children's Hospital letter of appeal once again demonstrates the importance of complete transparency.

"When institutions ask for public money they should be publicly identified. When they are rejected -- even if it's by members of a closed scientific brotherhood -- they should be identified and the reasons for the rejection should be spelled out.

"In this case CIRM management touted the 'successful' applicants and remained mum about what may, in fact, be excellent programs.

"Anything less than full disclosure leaves CIRM management justifiably open to charges of favoritism. In the long run that inevitably undercuts public faith in an agency whose dedicated staff in fact is attempting to serve the public interest by fostering important scientific research."

Rejected CIRM Grant Applicant Seeks Reversal of Action

One of the rejected applicants for CIRM's $263 million in lab construction grants has asked the agency's directors to reverse the decision and fund an effort that has an "immediate and broad application" in the treatment of sickle cell anemia.

Bertram Lubin, president of the Children's Hospital Oakland Research Institute, wrote members of the CIRM Oversight Committee on Dec. 28 seeking to overturn the negative recommendation by the CIRM Grants Working Group.

Lubin's letter follows CIRM's unusual reversal last month of its longstanding policy of secrecy concerning the names of grant applicants. In the case of the lab grants, CIRM identified 12 applicants that its Grants Working Group decided were worthy of funding by the Oversight Committee. The agency said public disclosure of the names would help the 12 institutions raise matching funds for the grant proposals. Grants with larger amounts of matching funds will have an edge in the competition for the CIRM money. However, the agency has refused to disclose the names of rejected applicants, a policy that has met objections from the Foundation for Taxpayer and Consumers Rights and the California Stem Cell Report.

Lubin (see photo) said his organization's proposal would expand a program "focused on clinical and preclinical research into the use of stem cells to cure inherited disorders of hemoglobin (sickle cell anemia and thalassemia), which affect a disproportionate number of children in California."

Lubin wrote:

"In contrast to some approved proposals that may have only distant and uncertain prospects of actually curing disease, our proposed facility would support the development of curative therapy with a new type of stem cell, with immediate and broad application to very large numbers of individuals."

He said the research involves umbilical cord blood stem cells and "will have a "direct and near-term impact on clinical practice."

Lubin continued,

"The cost of medical care for sickle cell disease averages over $50,000/year over a life expectancy of 30-50 years. In the course of our research, individuals with inherited blood diseases will receive transplants, and our extensive experience indicates these will be curative in the large majority of cases. The enhanced and extended lives of these individuals will represent a direct benefit; the savings to the health care system as a consequence of their cure is less direct but will benefit all California citizens. The knowledge gained from this research will enable improved treatment worldwide, with consequent saving of lives and resources."

Lubin also cited language in Prop.71 that states that CIRM should address the medical needs of the ethnically diverse population in California. Sickle cell anemia mainly affects African Americans in the United States.

The appeal from the Children's Hospital is the first such to surface publicly at the agency in any of its grant programs. We are querying CIRM about whether other applicants have appealed in this round or in the past.

The Oversight Committee will meet publicly next week to consider the decisions of the working group. Only grants that receive the go-ahead next week will go on to the next stage of the competition, which is the largest round of grants in CIRM history.

A copy of Lubin's letter was made available to the California Stem Cell Report by a source that asked not to be identified. The copy did not come from Children's Hospital. The full text of the letter is carried below.

Text of Lab Grant Appeal Letter

Here is the text of the grant appeal letter from the Childrens Hospital Oakland Research Institute.

December 28, 2007

Dear Members of the ICOC,

We are requesting that the ICOC reverse the decision of the Grants Working Group and recommend CHORI’s application for a Major Facilities Grant. We think it is very much in the interest of the citizens of California, and of CIRM itself, that this proposal be funded. We have proposed a facility that will expand and further develop a program focused on clinical and preclinical research into the use of stem cells to cure inherited disorders of hemoglobin (sickle cell anemia and thalassemia), which affect a disproportionate number of children in California. These disorders cause severe anemia with onset in infancy, but also widespread damage to vital organs such as brain, lung, liver and kidney. Our track record in this work is, we are confident, world-class.

Our request to the ICOC rests on the following points:

Our program has pioneered use of umbilical cord blood stem cells to cure genetic and malignant diseases in children; of particular significance is our demonstration that cord blood stem cells can be used to cure sickle cell disease.

CHORI laboratories have identified a new type of blood stem cell present in the placenta. These cells promise to provide a rich source of stem cells that will make curative therapy available to individuals who currently need it but do not have suitable stem cells available. Fulfillment of this promise will however require a program of rigorous preclinical and clinical research. The facility we have proposed is designed to house this research program. Our track record in curative stem cell therapy, and our discovery of these cells, make us the most suitable center to carry out the research.

The RFA for the Major Facilities Grant did not restrict the work to human ES cells and their derivatives. In fact, our application seems to fit precisely with the Program Objectives listed in the RFA. It is unusual only because we are proposing to carry out research that will have direct and near-term impact on clinical practice.

In framing our proposal, we had in mind the goals of Proposition 71 and of CIRM to serve the diverse population of California by encouraging ethnic diversity and participation in clinical trials focused upon the applicability of stem cell therapy. We have pioneered, and continue to develop, curative stem cell-based therapies for sickle cell anemia and thalassemia, which affect individuals from underserved minority populations in California.

Our proposal addresses another key goal of Proposition 71, which is to improve the California health care system and reduce the long-term health care cost burden on California through the development of therapies that treat disease and injuries with the ultimate goal to cure them. The cost of medical care for sickle cell disease averages over $50,000/year over a life expectancy of 30-50 years. In the course of our research, individuals with inherited blood diseases will receive transplants, and our extensive experience indicates these will be curative in the large majority of cases. The enhanced and extended lives of these individuals will represent a direct benefit; the savings to the health care system as a consequence of their cure is less direct but will benefit all California citizens. The knowledge gained from this research will enable improved treatment worldwide, with consequent saving of lives and resources.

In contrast to some approved proposals that may have only distant and uncertain prospects of actually curing disease, our proposed facility would support the development of curative therapy with a new type of stem cell, with immediate and broad application to very large numbers of individuals.

No resources to support construction of this facility are likely to be provided by the federal or state governments in the foreseeable future. We and our colleagues would welcome the opportunity to discuss this matter with you in detail.

Respectfully,
Bertram H. Lubin, MD
President, Director of Medical Research


Mark Walters, MD
Director, Blood and Marrow Transplant Program
Children's Hospital & Research Center, Oakland

No Stem Cell Sinecure at CIRM

The California stem cell agency is planning to make some pay changes for its staff and seems to be setting the stage with an interesting document that is now up on its web site.

In some ways, the three-page statement of "compensation philosophy" could be considered a list of the reasons not to work for CIRM. On the other hand, it is a realistic portrayal of work-life at the agency. The staff is tiny – now only 26 and limited to 50 by state law. The work is intense and demanding.

CIRM directors have repeatedly expressed concern about burnout. Seven persons, including some high level officials, have left since October.

Nonetheless CIRM offers some extraordinary opportunities to work at the cutting edge of science, government and business. It is doing pioneering work and is watched globally. It currently has a "wow" factor that has even enticed its new President, Alan Trounson, away from Australia.

Here is the segment of the compensation philosophy that might give pause to some who may be looking for a sinecure:

"CIRM recognizes recruiting and retention challenges that are unique to CIRM and that reduce the pool of talent available to the Institute. These include:

CIRM’s inability to offer tenured positions to any of its employees. All CIRM staff are at-will employees and can be terminated at the discretion of the President, which is a strength of the Institute but a liability for individual employees.

CIRM’s anticipated life-span is 10-14 years, which rules out the possibility of a longterm career track that is available for many civil service positions in the UC system.

"Due to CIRM’s projected limited life span, the Defined Benefit Plan (a traditional pension plan) is not perceived to be of significant value by staff members who will presumably have left the organization by the time they reach retirement age.

"The Defined Benefit Plan dictates a five-year vesting schedule, which is unattractive if the employee is with CIRM for a limited time period.

"CIRM has a defined contribution plan (e.g. 401K & 457) not supplemented with employer contributions.

"CIRM’s Conflict of Interest policy limits an employee’s ability to engage in outside opportunities to earn additional income through consulting and/or holding investments in organizations that can benefit from CIRM’s programs, including a requirement that employees divest themselves of any investment in a company that devotes more than 5% of its research budget to stem cell research.

"CIRM, unlike many of CIRM’s academic competitors, does not offer housing allowances, which is a significant challenge when relocating prospective staff to the Bay Area with its high cost of real estate and living.

"CIRM does not provide a long-term career path or advancement for staff within CIRM due to the limited number of positions defined by law to be within CIRM’s structure. Promotion can come only when existing staff members leave.

"Given our statutory inability to recruit a large number of new staff, CIRM employees need to be flexible and willing to transfer skills to support CIRM’s overall operating goals, which may go beyond bench-marked job descriptors gained from larger established institutions.

"Staff members need to be willing to be cross-trained as CIRM’s needs develop.

"As part of their job descriptions, CIRM employees need to be able to work “out of the box” in that they are to interact with institutions arround the world to ensure positive international relations."

The proposed changes in pay come up at next week's Oversight Committee meeting. No information on the specifics is yet available on the CIRM web site.

Correction

The "CIRM Perspective" item below incorrectly stated that the increase in the staff in the chairman's office was from four to 12 positions. The correct increase is from four to eight positions.

Limos, Red Flags and Perception

The California stem cell agency is excising the word "limousine" from its new travel and expenses policy after one director warned that it was a "red flag."

The action came at a meeting Monday of the Governance Subcommittee of the directors of the $3 billion research effort.

The subcommittee was reviewing a new travel policy aimed at dealing with some of the concerns of the California state auditor, who last year questioned lunches that cost $36, dinners that cost $65, pricey air travel and chauffeured limos, which the auditor said that CIRM preferred to describe as "large-sized vehicles" with hired drivers.

As prepared for the Governance Subcommittee, the new policy, which applies to directors, staff, out-of-state members of CIRM working groups and job candidates, permitted the use of limousines from airports and railroad stations.

Sherry Lansing(see photo), former head of a Hollywood film studio and chair of the Governance Subcommittee, said, "Limousines should be used only in extreme conditions because you can almost always get a cab." Claire Pomeroy, another member of the subcommittee and dean of the UC Davis medical school, said that the use of large rented cars with drivers "raises lots of red flags."

James Harrison, outside counsel to CIRM, said the policy would be revised to remove the word limousine when it comes before the full Oversight Committee next week. However, it appears that use of rental cars with drivers will be permitted under some circumstances. Robert Klein, CIRM chairman, suggested that "sedan service" be permitted when there is a necessity for speed or bad weather conditions exist.

Some subcommittee members noted that sedan service can be less expensive than cabs in some situations.

Lansing and Pomeroy are correct, however. The use of limousines at taxpayer expense is not something that sits well with the general public. Especially when the governor has just announced he will propose a budget that will hurt many groups, including AIDS patients, the poor and the elderly and slap a tax on renters, homeowners and business owners who buy property insurance.

No matter that the amounts for rental of "sedans" are relatively trivial. No matter that the money would not make even a dimple in the state budget crunch, even if the governor could lay his hands on the money, which he can't, thanks to Prop. 71. It's all about symbolism and perception and maintaining CIRM's reputation.

CIRM's Perspective on Staffing in Klein's Office

Robert Klein, the chairman of the $3 billion California stem cell agency, has taken issue with our piece on Friday entitled "CIRM's Klein Beefs Up Staff."

Ellen Rose, interim chief communications officer for the agency, sent along the following perspective today from agency after we discussed last Friday's item with both her and Klein on Monday.

"As you know, the board approved a new organizational chart in December that includes an increase from 4 to 8 people in the Office of the Chair and Vice-chair. We realized that it is not feasible to accomplish all of the responsibilities of the Office as outlined in Prop. 71 with just 3-4 people.

"During the next 1 to 2 years, CIRM will undertake two major, first-of -their kind funding programs - the Biotech Loan Program and the tax exemption status for the bonds - that involve up to $2 billion in value. Clearly, these are hugely complex and important funding programs and having the appropriate staffing and expertise in the Office of the Chair, which is tasked with their management, is necessary for successful development and execution of these programs. In addition, the Office of the Chair is responsible for intellectual property negotiation in the contracts for the Biotech Loan Program.

"The other increase in headcount is because Government Affairs has been transitioned back into the Office of the Chair. Prop. 71 calls for this function to reside there as part of the Chair's overall responsibility around interaction and education with government (CA Legislature, US Congress, and others), healthcare providers, the public, disease advocacy groups, and other key constituencies.

"Finally, as I mentioned yesterday, we will also increase the administrative help in the Office of the Chair because we want to facilitate more timely dissemination of materials to the public."

For those interested in reading more on this subject, here are some pertinent links:

Our item last year on the cutbacks in the chairman's office.

The old management structure presented to the Oversight Committee last March, which stipulated no more than four staffers in the office of the chair, which includes the vice chair.

The new management structure approved last month, which raised the number of staff from four to eight.
The organizational chart approved last month.

(An earlier version of this item incorrectly stated that the increase in the staff in the chairman's office was from four to 12 persons.)

Correction

On Jan. 4, in an item called "Klein Beefs Up Staff," we incorrectly reported that CIRM's chief communications officer reports to both the president and chairman of CIRM. Under the organizational chart approved last month, the communications position reports directly to the chief operating officer with dotted-line links called "access" by CIRM to the president and chairman.

Limos, Meals and More at CIRM

Ten months ago, the California state auditor took the California stem cell agency to task for sloppy bookkeeping and excessive travel and meal expenses.

The auditor found fault with lunches that cost $36, dinners that cost $65, pricey air travel and chauffeured limos, which the auditor said that CIRM preferred to describe as "large-sized vehicles" with hired drivers.

CIRM moved quickly to clean up its procedures for its staff. But the problems identified by the auditor involving CIRM directors remain uncorrected. Today, however, the director's subcommittee on governance will take a crack at a new travel policy for both directors (members of the Oversight Committee) and staff.

In at least one regard, the proposed new policies appear to roll back one of the changes backed by the auditor: elimination of the use of chauffeured cars. Whether the policies meet the auditor's standards in other areas is difficult to tell, but the complex documents contain ample flexibility, which some might call loopholes.

Normal limits on per diem expenses could be waived for foreign travel in the case of "a special event or function, e.g., a national or international sports event." First class air travel could be possibly permitted in the case of "unduly long layovers" or in the case of undefined "medical needs." And the use of limos would be permitted to and from an airport or railroad station.

The proposed travel policies to be considered this afternoon were not posted until late Friday on the CIRM web site. Missing were two important documents that should have been created in formulating the new rules. One would show how the new policy meets the problems detected in the audit last year. Another would show how the proposed CIRM policy diverges from the University of California travel policy on which it is based(another issue in the audit). A possible third document would show how the new policy is changed from the existing policy and how the proposed staff and director policies diverge from each other.

The state auditor did not wait until her report was published in February of last year to tell CIRM about some of the problems she had detected. Former CIRM President Zach Hall dealt early on with many of the issues involving staff. But as for the travel policies for CIRM directors, the audit stated, "According to the institute president, institute staff did not presume to suggest a policy for the committee." Dealing with those is the responsibility of Chairman Robert Klein.

In terms of raw dollars, the amounts involved in CIRM travel and expenses are piddling compared to its whopping multimillion dollar grants, probably not more than a few hundred thousand dollars although details cannot be found in the latest CIRM budget documents. But talk of chauffeured limos and $65 dinners does not sit well with the public or the media. Few persons can understand what $1 billion means. It is much easier for your average Californian, who is paying $4 a gallon for gas in some locations, to grasp a vision of limos and luxury lunches – an image that does not serve CIRM well.

(Editor's note: Some of the rules for expenses are linked to a "business meeting expenditure policy" that is yet to be approved or posted on the CIRM web site.)

Two San Diego Area Firms Seeking Cash From CIRM

Novocell and International Stem Cell Corp. are among the first 10 companies seeking grants from California's $3 billion stem cell agency.

Reporter Terri Somers of the San Diego Union-Tribune wrote Sunday about their plans as part of a story on CIRM's efforts to pump money into the stem cell business.

Somers' story was the first to disclose the names of any applicants for disease team planning grants. CIRM has refused to disclose the names of organizations seeking millions of dollars in public funds on grounds that they would be embarrassed if they were not awarded a grant. However, last month CIRM reversed itself on the names of 12 applicants for $263 million in lab construction grants, identifying them in order to give them a leg up on raising matching funds to help their applications.

Somers wrote,

"Novocell (a privately held company in San Diego) is developing a diabetes treatment that would create insulin-producing islet cells from human embryonic stem cells. It then would coat those islet cells in a polymer to make the cells invisible to the body's immune system, so they would not be rejected or require the patient to take immune-suppression drugs.

"The company plans to be part of two disease teams, Alan Lewis, chief executive, said.

"One team, which Novocell would lead, would include scientists from academia as well as a company from outside San Diego, Lewis said. That company, which he declined to name, has more expertise in development than Novocell, which is focused on research. He wouldn't name the academic part of the team."

As for International Stem Cell, a publicly traded firm in Oceanside, Ca., Somers reported that it "has created corneas using embryonic-like human stem cells derived from an unfertilized egg."

She continued:

"The company would have liked to create teams for several diseases, but for this planning grant the stem cell institute limited companies to being the lead investigator on only one team, said Jeff Krstich, chief executive.

"Nonprofit institutes, including universities, which generally have researchers with expertise in more areas than a company, can apply to lead four disease teams.

"International Stem Cell's team is all internal, and plans to focus first on corneal implants, Krstich said. Last year the company published a scientific journal article showing that it can create corneas from embryonic-like stem cells it created from a process known as parthenogenesis, which involves using an unfertilized egg rather than an embryo."

Somers also had an interesting comment from Lewis concerning the ongoing and contentious debate about sharing revenues that might result from CIRM-funded inventions. Some who claim to represent industry seem to balk at such requirements. But Somers wrote,

"'We weren't expecting free money from CIRM,' said Lewis of Novocell. 'Obviously there needs to be a benefit to the California taxpayers down the road, when a product is approved.'"

Somers' article and the willingness of the two companies to discuss their plans add useful information to the dialog about stem cell research in California. She also indirectly exposed some of the silliness in CIRM's refusal to disclose information about how it is going about the public's business. In this case, she said that CIRM would not provide a breakdown of the diseases targeted by those intending to seek planning grants. No reason was given in Somers' story, and it is hard to imagine how CIRM could concoct one that could be construed to be in the public's interest.

The Cerberus and The Scientist

Leanne Jones watches fruit flies. John M. Simpson watches the Oversight Committee of the California stem cell agency.

Both Jones (see photo) and Simpson came together on Sunday in an article about the scientist and the watchdog by Bradley J. Fikes on the North County Times in the San Diego area.

Fikes wrote about their different perspectives on the $3 billion research effort that has come to be so important in their lives. In the case of Jones, the Oversight Committee last month approved a $2.7 million grant for Jones and her work at the Salk Institute.

Fikes wrote,

"'Early on in your career, you have all these ideas, and you have to be very focused because your funds are so limited,' Jones said. 'Since I started my lab, I've had to spend a considerable amount of time writing grants to try to fund the lab once my initial funding from the Salk ran out. That meant that I could do very little in the way of "hands-on" experiments.

"'This CIRM grant gives me enough of a base so that I don't have to write grants for a while, which means I can spend more time in the lab actually doing the experiments, rather than just talking or writing about them. ... This is going to be fun.'"

As for Simpson, he described his role as a constructive effort to make sure that taxpayers get what they pay for and to ensure that CIRM research benefits the public at a price that people can afford. Simpson also noted that his organization, the Foundation for Taxpayer and Consumers Rights, has acted to remove impediments to stem cell research in general, citing the challenges to the stem cell patents held by WARF.

CIRM Directors Meet to Mull More Faculty Awards, Mega Millions for Labs

Coming up in the middle of this month is the $263 million California stem cell lab construction bonanza, but some other items are also up for consideration by directors of the state's stem cell agency.

CIRM has posted the agenda for the two-day session beginning Jan. 16. Besides the largest round of grants in CIRM history, the Oversight Committee is scheduled to take up a proposal to "make whole" -- sort of -- the 10 scientists who suffered as a result of breaches of CIRM's conflict of interest policy by the deans of their medical schools.

No details are yet available on the posted agenda, but CIRM plans to offer a new round of faculty award grants. Initial discussions indicated that it would be open to all (with qualifications)– not just the those who were dumped from last month's $54 million round.

Also on the agenda are compensation changes, travel policy and new plans for conferences and meetings. Some of those will mean increased spending, although no details are yet available on the CIRM website.

As for the "Mega Millions Jackpot" – whoops, that is another California state program -- for lab construction, if CIRM holds to past practice, sometime between now and Jan. 16, we should see the postings on the public summaries of the grant reviews for 12 institutions that were anointed earlier. Given the complexity of the proposals and staff turnover at CIRM, we would expect to see the summaries later rather than earlier, which would make it difficult for the public or other interested parties to review them and prepare comments for the Oversight Committee meeting.

Trounson on Appreciation

Alan Trounson, the new president at the California stem cell agency, has replied to the note of appreciation from John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights.

Here is the text of Trounson's letter:

"Thanks for your comments. We do take note of all inputs from all sources. I am particularly keen to guide the program towards clinical applications based on the best available scientific data. These young people are critical to this particular objective.

"I look forward to a constructive relationship that can extract the best of the incredible opportunity the people of California have provided through Prop 71.

"My very best wishes for a happy, safe and productive New Year."

CIRM's Klein Beefs Up His Staff

Less than one year ago, the directors of the California stem cell agency cut back to three the size of the staff of the chairman, Robert Klein, in an effort to make the job of president of the $3 billion effort more appealing to candidates seeking to fill the post.

Today, CIRM has its new president. And the authorized staff for Klein's office has ballooned to eight, which may not seem large, unless one considers that it amounts to about one-third of CIRM's tiny and overworked contingent.

The new positions were approved with little discussion last month by members of CIRM's Oversight Committee. Interim CIRM President Richard Murphy, who is being replaced by Alan Trounson, presented the positions to the board as part of a staff reorganization supported by Trounson. Murphy indicated Trounson may seek to modify the organization further as he settles in.

CIRM has been bedeviled by a dual executive structure, locked into state law as the result of being codified as part of Proposition 71 and which has played a role in conflicts between Chairman Klein and former President Zach Hall. At one point last year, Murphy, then a member of the Oversight Committee, called the management structure a "dog's breakfast."

Some observers say the structure now in place puts the agency firmly under Klein's control, and they expect Trounson to fill a much different role than Hall performed. They also say that Klein's dominance has played a role in the recent troublesome staff turnover – eight departures since October.

(Klein is a multimillionaire real estate investment banker who does not accept a salary for his position at the state agency. He has testified in court that he does not consider himself a state employee.)

The latest organizational structure calls for a new director of finance, legal and governmental affairs, who will have three staff members – all within the chairman's office. An associate legal counsel has also been shifted away from the president and works outside of the regular purview of CIRM's general counsel. Trounson reports directly to Klein.

No salary is listed on the web site for a director of finance, legal and governmental affairs, and the position is not currently listed as open for applicants. One position that is currently being advertised is for a chief operating officer, who will work under Trounson, and who should free him from much of the tedious work of the agency. No salary is listed for that position as well, but it could be as much as $270,000 annually, which is the top end of the range for the chief scientific officer, a parallel position that is vacant.

Formal organizational structures are sometimes nothing more than wish lists. But some time and effort have obviously been put into this one to deal with both Klein's and Trounson's desires. How it all works will play out during the next year. But management problems are a continuing issue at CIRM. And it is clear that CIRM needs to halt the turnover in employees and hire new staff as quickly as possible.

(An earlier version of this item incorrectly stated that the chief communications officer reports to both the chairman and the president.)

Stem Cell Snippets: Toes, Public Support and Looking Forward

WSJ on Stem Cells – Columnist Robert Lee Hotz wrote today in the Wall Street Journal about non-federal stem cell research efforts and reprogramming of stem cells. He quoted Richard Murphy(see photo), interim president of CIRM, as saying that research on human embryonic stem cells must continue. "We need to sort out the realities," Murphy said. The piece also contained a forward-looking number that is increasingly turning up in articles involving CIRM. That is the figure of $519 million, which is what CIRM expects to have approved for stem cell research by the middle of this year.

Bad Poll Numbers – "Strong support" is declining for human embryonic stem cell research, according to a recent poll by the Virginia Commonwealth University. The survey was taken following the latest news on reprogramming of adult stem cells. According to a piece by A.J. Hostetler of the Richmond Times-Dispatch, "strong support" peaked in 2005 at 27 percent and has now fallen to 21 percent. Overall support remains at 54 percent. It is the first national poll taken on stem cell research since the announcement of the reprogramming studies in November.

Murphy's Toe? – Reporter Ron Leuty of the San Francisco Business Times put together a bit of an overview of CIRM recently. The main focus was on the conflict of interest problems at the agency. He quoted Richard Murphy as saying, "We stubbed our toe. We all didn't realize we had a problem here." Michael Fitzhugh of the East Bay Business Times also looked at the impact of CIRM activities on companies in the eastern area of the San Francisco Bay region. If you have difficulty obtaining full copies of the articles, please send a request to djensen@californiastemcellreport.com, and we will send them to you.

FTCR on Appreciation

Following the appearance of an opinion piece Thursday in the San Jose Mercury News, John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights, sent the following letter to Richard Murphy and Alan Trounson, respectively the interim president and new president of CIRM:

"I enjoyed reading your joint article in today's San Jose Mercury News. It did an excellent job of highlighting the positive things the stem cell agency has done -- and is doing -- for the state.

"As you know, I've had differences with CIRM on occasion and, I am sure, will again in the future. I've always tried to offer constructive criticism that is intended to improve the agency and make it more responsive and accountable to those who fund it -- the people of California.

"You were correct when you wrote that there is much about the California Institute for Regenerative Medicine for which Californians should be proud. Funding promising young scientists is but a part.

"From my perspective, as I've served as a watchdog over the agency for the past two years, one of the things that has consistently left me with good feelings -- perhaps even a sense of pride -- is the dedication, commitment and devotion demonstrated by CIRM's hardworking staff. Too often they are under appreciated or at least taken for granted.

"So as we start a New Year, I wanted to make a point of lauding their contributions.

"I look forward to working with you in the year ahead. I'll continue to speak out when you're off track; I hope I'll be just as quick to praise what's right.

Fresh Comment

"Anonymous" has posted a new comment on the "withholds routine information" item below, suggesting that this writer has been at sea too long.

CIRM Moves to Refocus Public Debate

The outgoing and incoming presidents of the California stem cell agency published a piece in the San Jose Mercury News today defending the agency, declaring that the state's taxpayers should be proud of CIRM's efforts.

The op-ed article was written by Richard Murphy, interim president of CIRM, and Alan Trounson, who is the new permanent president.

In it, they point to the recent $54 million in grants to scientists as a sign that the CIRM is doing well. Little is new in the piece, but it represents an effort by CIRM to refocus public discussion of the agency in a more positive light following weeks of more negative news coverage.

Fresh Comments

"Anonymous" has posted a comment on the "withholding routine information" item below raising questions about the point of the item. We have posted a response suggesting there are three billion reasons underlying the post.

Business Joins CIRM Competition; Stanford Moves Craftily

Ten companies have submitted the first-ever letters-of-intent from the private sector for grants from the $3 billion California stem cell agency, and their chances may be better than those of some of California's finest universities.

The reason? CIRM is eager to develop interest and participation in its programs from stem cell companies. The general idea is that business would be faster at bringing therapies into the market place.

The number of letters of intent for the $1 million in disease team planning grants was disclosed today by CIRM. In addition to the 10 letters from business, the institute said that 56 letters were received from "non-profit institutions." The agency did not break down that number between educational institutions and research nonprofits.

CIRM next June plans to approve about 20 grants of up to $55,000 each. The grants would be an important stepping stone to the much larger, $122 million disease team grants.

The Stanford University School of Medicine, meanwhile, is not waiting for CIRM grants. It announced seven days ago that it was funding four disease team planning grants at $50,000 each beginning virtually immediately. Stanford apparently believes the early move will give it a leg up for the larger grants. Those being funded and pictured above are Irv Weissman(with microscope), Judith Shizuru(upper left), Gary Steinberg(in lab coat) and Beverly Mitchell(upper right).

The four grants are in addition to the four that will be submitted to CIRM, which has limited the number of applications to four from each institution.

Stanford, whose medical school dean, Philip Pizzo, is a CIRM director, has swept up $41 million in CIRM grants, more than any other institution. It might behoove others to look to their own grant-winning strategies in light of Stanford's move on the disease team planning grants.

Letters of intent were received eight days ago by CIRM, which chose to withhold the numbers until today for reasons that are not clear.

Another note: CIRM religiously refuses to release the names of grant applicants, claiming that they would be embarrassed if they lost. Stanford, like a number of others, seems to disagree about the possibility of embarrassment given that it has now disclosed that it is seeking at least four planning grants from CIRM. Of course, the hypocrisy of CIRM's secrecy policy on the names of applicants became evident earlier this month when it chose to identify 12 applicants for $263 million in lab construction grants a full month in advance of the date they are scheduled to be approved.

CIRM Withholds Routine Information on Interest in Disease Team Grants

The California stem cell agency Friday declined to disclose the numbers that would provide some indication of how businesses are responding to the agency's first-ever attempt to solicit grant applications from the private sector.

Thursday was the deadline for letters of intent to apply for $1 million in grants to plan a disease team effort. The planning grant program is a key entry point for those who want to participate in a later, $122 million disease grant round.

Ellen Rose, interim spokeswoman for CIRM, on Friday said the institute was not providing any count of the letters of intent or breakdown because it was "busy." She said CIRM intends to "address the level of interest" in the disease team program "sometime after the holiday."

Up until recently, the agency routinely and quickly released the numbers of letters of intent and applications for grants. However, the number of applications for the lab construction grants was delayed for days this fall. At the time, Interim President Richard Murphy said he preferred not to release any count.

However, the number of applications and letters of intent is a routine matter and legally public information. Refusing to release it in a timely fashion does not meet CIRM's claim to adhere to the highest standards of openness.

Often when public agencies delay the release of information, it means the information is negative and reflects poorly on the bureaucracy in question. Other times, it can mean that the agency is trying to figure out how to spin the information. We suspect the latter is what is occurring in this case.

Businesses Give Mixed Response to CIRM Overtures

The San Jose Mercury News has taken a brief look at the reception that business is giving plans by the California stem cell agency to provide millions of dollars for research in the private sector.

Based on a small sampling, the response is mixed. StemLifeLine of San Carlos says it is not planning to apply because of requirements that the state receive a payback on any revenues that may result, according to reporter Steve Johnson.

Advanced Cell Technology of Los Angeles, on the other hand, is interested. It moved its headquarters to California last year because of the possibility of securing funding from CIRM.

Geron of Menlo Park says it is not applying because its technology has advanced beyond the levels funded by the institute.

WaferGen Bio-systems of Fremont is considering applying but is concerned about the revenue sharing.

StemCyte of Arcadia said that it has filed a letter of intent to apply for a disease-team planning grant. The deadline for those letters came Thursday. CIRM , however, that it is not sure that it will be able to supply figures today on the number of applications, including those from business.

CIRM Chairman Robert Klein said,

"We will try to work with industry to find how we can further the interests of California patients and the biotech sector."

Anointment and The 92 Percent Routine at CIRM

Directors of the California stem cell agency last week virtually rubber-stamped the actions of its scientific grant reviewers, going along with them on 92 percent of the applications for $54 million.

The Oversight Committee discussed only nine of the grants, the ones reviewers said were recommended for funding if money was available. Five of those were approved by the committee. It ratified decisions on another 39 with zero debate. None of the committee's actions reversed a decision by the reviewers to deny or approve outright a grant application.

This pattern lies at the heart of whether the scientific grant reviewers, who make the critical decisions on requests for hundreds of millions of dollars in public funds, should be required to disclose publicly their financial interests. After spending months examining CIRM earlier this year, Elaine Howle(see photo), California's state auditor, recommended that the agency seek an attorney general's opinion about whether reviewers should publicly disclose their economic interests.

The agency rejected the suggestion. Interim CIRM President Richard Murphy last summer wrote the auditor that she was raising a "hypothetical" point. He said,

"...(T)he recommendations of the CIRM working groups have never been routinely and/or regularly adopted by the ICOC...."

CIRM has not published its analysis of the grant approval patterns, but our experience indicates that it is close to last week's 92 percent rate.

The power and importance of the grant reviewers were further reinforced last Friday when CIRM disclosed for the first time the identities of 12 applicants for $263 million in lab construction grants. The unusual release of information came more than a month before the grants are scheduled to be approved by the Oversight Committee. CIRM said the 12 were "recommended" for funding by the scientific grant reviewers. The agency said it was releasing their names because it would assist in end-of-the-year fund-raising for matching monies that are critical to the grant application.

Significantly, the names on the five applications rejected by the reviewers were not disclosed. CIRM says it does not disclose the names of the institutions for fear of embarrassing them. But the anointment of the 12 and the release of their names makes it virtually impossible for the non-anointed to make a renewed effort for funding, although by CIRM's official lights, the game is far from over. But how can the supposedly "semi-rejected" possibly muster the critical matching funds minus CIRM's endorsement on Friday? How can they go public with complaints about the fairness of the process? One does not want to antagonize a $3 billion gorilla that controls the lifeblood of research. One can only imagine the frustration at those institutions about how this has been handled.

Under Prop. 71, the Oversight Committee has final legal authority to approve or reject grants. We have long contended that reviewers are making de facto decisions on the grants as they did in last week's case of the $54 million in faculty awards. All of which is not unusual. That is why an agency such as CIRM has expert reviewers. They should know the science best.

The Oversight Committee is also hobbled if it wants to act independently of the reviewer decisions. The panel not only cannot see the entire application for the grant, it does not know the names of the institutions or the researchers involved. The committee is given only summaries that do not identify even whether the researcher is male or female. (However, a knowledgeable person can often determine the names of the institutions and sometimes the researcher by a careful reading of the summaries.)

Currently the reviewers disclose their economic and professional interests to CIRM, which says it will review them be sure no breaches of ethics or law occur. But neither the public nor applicants have any way to ascertain for themselves whether conflicts do in fact occur, other than trusting the tiny CIRM staff to diligently examine the secret documents.

CIRM contends it will lose reviewers if they are compelled to disclose publicly. We concede that a few may leave, but as new CIRM President Alan Trounson has noted, California is hottest spot in the world for stem cell research. A researcher who gives up an inside seat at that table would be giving up a lot.

The scientific reviewers are in fact making the overwhelming majority of decisions on grants being handed out here in California by what is the world's largest source of funding for human embryonic stem cell research. Given CIRM's on-going issues with conflicts-of-interest, it is past time for the agency to publicly disclose the economic interests of its reviewers.

FDA Calls April Meeting for Stem Cell Testing Advice

Clinical trials for therapies using human embryonic stem cells seem to be creeping closer with the latest news coming from the US Food and Drug Administration.

The FDA Tuesday announced a meeting April 10 to seek advice concerning "scientific considerations for safety testing" of such therapies. Two California firms, Geron and Advanced Cell Technologies, say they plan to send representatives to the meeting. Both have also indicated they hope to begin clinical trials next year.

Luke Timmerman and Rob Waters of Bloomberg News reported that Reni Benjamin, an analyst with Rodman and Renshaw in New York, said the FDA meeting is unusual because "the agency typical seeks advice on whether to approve a tested drug, not on how to proceed."

According to the two reporters:

"Geron has communicated extensively with FDA reviewers over the design of the first human trial using embryonic stem cells, partly to convince the agency that putting the cells into people won’t result in the growth of abnormal cell clusters called teratomas, Thomas Okarma, Geron’s chief executive officer, said in interviews with Bloomberg."

Bloomberg said that ACT plans to submit a clinical trials application in the first half of 2008 for a treatment using retinal cells.

Major Staff Turnover at California Stem Cell Institute

More than 25 percent of the staff of California's $3 billion stem cell agency has left since October or is leaving -- a turnover rate that is troubling as new president Alan Trounson prepares to take over.

The departures total seven persons, including top level executives, out of a staff of 26. At least one other top level person is reported to be considering leaving. Publicly, the announced reasons seem benign, as they usually do in such cases, but the turnover is cause for concern. Moreover, some are leaving after only working for CIRM for relatively short periods.

CIRM has always had a small staff and is limited to 50 by law. Long hours have been the rule, not the exception. Oversight Committee members repeatedly have expressed concern about burnout and the staff's ability to accomplish the growing number of tasks that the agency is attempting.

Hiring new employees is time-consuming and expensive. New staffers always have a learning curve to climb, plus institutional memory is lost as the employees depart.

Four departures were announced at last week's Oversight Committee meeting by interim President Richard Murphy, who also announced the hiring of four new persons. The four leaving are Lori Hoffman, chief finance and administrative officer; Rosemary Chengson, finance officer; Dennis Butler, technology officer, and Mario Garcia, grants management specialist. Arlene Chiu, chief scientific officer, and Dale Carlson, chief communications officer, left in October. Kumar Hari, a scientific officer, said this week he is leaving to return to private industry.

In another personnel matter, Murphy announced early in last week's Oversight Committee meeting that he hoped to have a new chief scientific officer on board following approval of the person during an executive session of the Oversight group. However, no name was announced following the executive session.

Murphy did announce the name of a new chief communications officer, who will begin work in mid-February, Don Gibbons, currently associate dean for public affairs(see item below) at Harvard Medical School.

The other three new employees are scientific officers:

Elizabeth Ashe Nigh, a neuroscientist from Harvard Medical School, Uta Grieshammer, a developmental biologist from UCSF, and Mike Yaffe, currently a full professor at UCSD interested in the biology and genetics of mitochondria.

CIRM Hires Communications Chief from Harvard

The California Institute for Regenerative Medicine has hired a new chief communications officer, Don Gibbons, currently the associate dean for public affairs at Harvard Medical School and once the director of communications for the Stanford Medical Center.

Gibbons (see photo) is expected to be at the agency fulltime in mid February. Gibbons has been at Harvard since 1996. He worked at Stanford from 1992 to 1996. Prior to that, he was editor-in-chief at Medical World News, where he worked in various capacities from 1982 to 1991.

Gibbons has a bachelor's degree in biology with an emphasis in journalism from Indiana University. He will be paid $190,000 or $195,000 annually depending on the size of his relocation package.

Communications responsibilities at CIRM are currently being handled on contract on an interim basis by Ellen Rose, formerly with Alza, a drug delivery subsidiary of Johnson and Johnson. She is working half-time. CIRM on Monday posted an RFP for a $60,000 contract for more temporary PR help.

Fresh Comments

"CIRM" has left a comment on the "Shame, Shame, Shame" item below. " We have also posted a response to it. "Anonymous" has left a comment on the "Lesson" item from Dec. 15.

Sham Arguments Harm CIRM's Credibility

The release of the names of 12 institutions seeking $263 million in public money from the California stem cell agency doesn't measure up to the agency's self-professed goal of meeting the highest standards of openness and transparency.

Yes, it is a good first step, whatever its motivation. Yes, it seems to surpass the openness of the NIH. But as we have noted before CIRM is subject to far less oversight than the NIH and seems to have far greater conflicts of interests among its directors. But if the intention is to provide the basis for thoughtful comment from either the public or CIRM's important constituencies, the release of the information falls short.

All that is publicly available are names. The public, which is financing this effort, does not know how much money is being sought nor even rudimentary details of how the applicants propose to use the cash.

CIRM's position is that to release the information at this point could mean that losing institutions would be embarrassed. However, by releasing the names last week, CIRM has conceded that its position is nothing more than a sham. Presumably some of those named on Friday will lose out and be "embarrassed."

CIRM apparently decided that embarrassment was overshadowed by the need to help applicants raise matching funds for the grants before the end of the year.

It is time for CIRM to release not only the names of the institutions, but also the amounts they are seeking as well as the applications from the institutions(confidential information could be deleted).

The agency is still wrestling with the fallout from controversy about its conflicts-of-interest, which have possibly cost 10 researchers about $31 million. It is an issue that will be with CIRM for its entire existence because the conflicts are built into the agency, ironically, by law. More than a majority of the CIRM's directors have links to institutions that could benefit by this latest round of grants for lab construction. They have already set the rules and criteria for giving away the money. All of which naturally raises concerns about self-dealing or worse.

That situation is not likely to change. The only reasonable way to assure public credibility and allay suspicions is for CIRM to lay all the stem cell cards on the table. Especially since it has conceded that releasing the names is not really that embarrassing after all.

Shame, Shame, Shame

If you accept CIRM's arguments for withholding grant applicant information, the San Diego Stem Cell Consortium has taken an enormous risk that it could shame itself in public.

The consortium says it is seeking $50 million from CIRM for new lab construction, according to a report by Terri Somers of the San Diego Union-Tribune. The new building would give 110 scientists a place to work. It would be built on UC San Diego property with construction beginning in 2009. The San Diego Supercomputer Center and Craig Venter, the biologist who was a primary driver of the Human Genome Project, also plan to contribute to the project.

All of that is considered confidential information by California's stem cell agency, which plans to give away $263 million in public money next year for new lab construction. CIRM considers the information so sensitive that the release of it would severely embarrass the consortium if its request for funds is turned down.

Balderdash, is what we say.

Gritty Stuff in Trounson Story

For those of you still wondering who Alan Trounson is – or for those who want to known more – reporter Deborah Smith has produced an interesting profile with some gritty details.

Writing in the Sydney Morning Herald, she described Trounson at one point while he was on a flight from Singapore as a "slightly crumpled, middle-aged traveler." She wrote that years ago someone painted "Trounson is a mass murderer" on the walls of his home. And she reported that private detectives have "trawled" through his financial dealings and quizzed his former wife.

Trounson's comment, "That was very strange. They were tough times."

Trounson begins work in the next couple of weeks as president of California's $3 billion stem cell agency agency, the world's largest source of funding for human embryonic stem cell research.

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