Friday, June 10, 2005

Special Insights vs. Possible Special Interests

The building blocks are slipping into place. The California stem cell agency has approved the membership of its facilities working group, including four high-powered "real estate specialists."

The law requires that four members of the group be persons with special knowledge of the real estate industry. What that means is that they have deep roots and ties to the real estate business. Nothing wrong with that. They will bring special insight and knowledge that can be very useful to CIRM. It also means that they may have financial interests that may conflict with the interests of the people of California. Under the current CIRM rules, the people of California will never know what those interests might be. They have to trust the agency and the appointees.

The agency issued a press release on the appointments which said:

“Building research facilities for stem cell research will be a top priority for the CIRM. Current federal restrictions on use of laboratory equipment and space add a special urgency to the mission of the Facilities Working Group,” said Interim President Zach Hall, Ph.D. “This outstanding team of experts will ensure that California stem cell researchers will have high-quality laboratories built in a cost-effective manner.”

"The 11-member Scientific and Medical Research Facilities Working Group makes recommendations to the ICOC that governs on interim and final criteria, requirements and standards for applications for, and the awarding of, grants and loans for buildings, building leases, and capital equipment. The Facilities Working Group will also make recommendations to the ICOC on oversight procedures to ensure grantees’ compliance with the terms of an award."

Here is a look what the agency has to say about the four:

"David Lichtenger is President and Chief Executive Officer of Integrity Office Solutions (IOS), which he founded in 1999. Over the past 20 years, Lichtenger has been personally involved in the planning, design, and construction of over 10 million square feet of projects. IOS project management includes: real estate site and lease evaluation, needs analysis, architectural design, engineering, construction, technology, furniture, A/V, security and relocation services with a guaranteed price and schedule completion date. Projects have included many types of facilities: mission critical data centers, biotechnology and engineering laboratories, clean rooms, medical facilities, offices and manufacturing facilities. IOS serves clients across business sectors: technology, medical device, biotechnology, consulting, financial, healthcare, manufacturing, and non-profit. Prior to IOS, Lichtenger was involved in various real estate development projects."


"Edward M. Kashian of Fresno is the CEO and founder of Lance-Kashian & Company, one of the Central Valley’s leading firms in real estate development, asset management and property management. It has served California since 1964, developing regional shopping centers, office complexes, industrial projects and pioneering master-planned corporate communities. Kashian was a partner in the first “power center” built in the country, which still exists in Fresno. Currently he is the managing partner for River Park Properties, developers of River Park Shopping Center, the co-managing partner for Fancher Creek Properties, LLC, a general partner of Kashian Enterprises and the Fresno Historic Chinatown, LLC."

Deborah Hysen is currently Project Director for the California Performance Review, adjunct to the Department of General Services (DGS). She is responsible for start-up and day-to-day functions of this comprehensive review of government established by Governor Arnold Schwarzenegger in 2004. Hysen previously served as Acting Chief Deputy Director at DGS, where she directed the operations of 14 operating divisions and offices providing services to state agencies throughout California, including the Division of the State Architect, Real Estate Services, Office of Public School Construction and Procurement. As a Senior Property Manager at Insignia Commercial Group, she established and implemented policies and procedures that governed the financial performance of the Citibank Building in Los Angeles, a one million square foot Class “A” high-rise. Hysen was previously a property manager for Columbia Savings and Loan, followed by three years as General Manager of Optima Capital Management.

"Albert “Rusty” Doms was CEO and President of his company, Karsten Realty Advisors, from 1972-1994. The company provided real estate investment management services for pension funds and development management services. Before running Karsten, Doms spent six years at Economics Research Associates performing market research and financial feasibility studies for real estate and recreation properties. Mr. Doms has spent several years in service to his community and volunteering for non-profit organizations in various roles, such as Pomona College, the Children’s Bureau, the Los Angeles Building Authority, St. John’s Health Center Foundation, and the Project Advisory Committee for Los Angeles County."

For more details on their professional background see this link.

A Retrospective on Prop. 71 in Houston

If you are looking for a hot time this weekend – stem cell wise – check out Houston.

The Stem Cell Policy and Advocacy Summit gets underway there beginning tomorrow. The Genetics Policy Institute, which is sponsoring the conference, says, "This is a critical time for the advocacy community to develop winning strategies to overcome Draconian legislation and secure adequate funding for research."

South Korea's Woo Suk Hwang will appear. Also scheduled is a look at California post-Prop. 71, including a talk by Jim Battey of the NIH. The political consultant behind the Prop. 71 campaign, Paul Mandabach, and others involved in the campaign will be appearing as well.
You can read more about the conference here.

Wednesday, June 08, 2005

Effort to Shunt SCA13 Fails

The proposed ballot measure to tighten oversight of the California stem cell agency has survived a move to sidetrack it back into a legislative committee. The legislation remains on the Senate floor and could come up for a vote as early as Thursday (June 9).

Sen. Joe Dunn, D-Santa Ana, who has made his legislative bones chewing up energy companies, Wednesday futilely attempted to have the proposal sent to the Judiciary Committee, which he chairs, although the bill has already cleared three legislative committee.

CIRM and Sen. Deborah Ortiz, D-Sacramento, are at loggerheads over her proposed constitutional amendment. Ortiz supported Prop. 71, which created the stem cell agency, but believes the agency should be more accountable and open and ensure that therapies developed with state funds are available to all. The agency believes her measure, SCA13, would cripple the agency and delay cures that could save lives.

One of the key CIRM arguments holds that SCA13 would endanger the issuance of the $3 billion in bonds to fund research. But the state's bond counsel, Orrick, Herrington & Sutcliffe, denies that in a very brief June 7 memo to Ortiz and stem cell chairman Robert Klein.

If you are truly a policy wonk, here are the two salient paragraphs from the memo:

"As drafted, we do not believe the new Section 9(a) (of SCA13) would be an impediment to the issuance of bonds by the State. This is based on the inclusion of the term 'seek to ensure' in the measure, which changes this from a prescriptive rule to a statement of intent or aspiration. We do not believe officials at the ICOC would have a difficulty certifying that they will be seeking the results set out in Section 9(a), although of course we cannot speak for them. We understand the language circulated at the ICOC meeting yesterday (Monday) morning did not include the words 'seek to.' In the absence of those words, we would continue to believe, as stated in a prior Memorandum to (an aide to Ortiz), that such a provision in Article XXXV would be a significant problem for the issuance of bonds.

"Nothing in the proposed Section 9(a) interferes with the ability of the State to issue tax-exempt bonds. As we have stated numerous times in writing and in conversations with you, the final determination of our ability to opine on the tax exemption of any particular issue of State bonds will depend on many factors, including the exact terms of intellectual property conditions which are included with grants or loans made by the CIRM."

The Bee: State Bond Counsel Says No SCA13 Problem

California's bond counsel says the proposed stem cell ballot measure will not interfere with the ability of the state to issue stem cell research bonds, contrary to the position taken by CIRM.

The Sacramento Bee Wednesday disclosed the existence of the memo from Orrick, Herrington & Sutcliffe. The Bee said in an editorial, "(Sen. Deborah) Ortiz has worked to amend her measure so it would have no possible impact on the issuance of stem cell bonds. The state's bond counsel - Orrick, Herrington & Sutcliffe - confirmed that point Tuesday when it issued a memo stating: 'Nothing in the proposed Section 9(a) interferes with the ability of the state to issue tax-exempt bonds.'"

The piece also discussed the opposition of Democratic senators, Sens. Jackie Speier, D-Hillsborough, and Joe Dunn, D-Santa Ana, to SCA13. Dunn is reportedly seeking to have the measure removed from the Senate floor and sent to the Judiciary committee he chairs. The measure has already been through three Senate committees.

The Bee said, "Dunn and Speier have built their reputations on consumer protection, accessible health care and open government. But Monday, they blatantly pandered to stem cell czar Robert Klein II, who orchestrated a lobbying campaign Monday against Sen. Deborah Ortiz, D-Sacramento, and her SCA 13 measure.

"Ortiz's measure, among other things, would guard against public funds going to companies that secretly set up consulting and stock deals with scientists who recommend the funding.

"This is not just an abstract concern.

"As Dunn knows, the energy giant Enron secretly paid researchers at Harvard to churn out reports extolling the deregulation scheme that California ultimately adopted. Those conflicts came to light only after California became mired in an energy crisis Enron helped create."

Dunn has been heavily involved into looking to energy issues related to the California electricity crisis of a few years back.

Chron Makes Stem Cell News Easier to Find

The San Francisco Chronicle is aggregating its stem cell coverage online, a move that should be emulated by other California newspapers and news sites. Now if the SFGate would only put an RSS feed on the package so that it would alert "stemmies" automatically when updates are made. You can see what appears to be all of the 2005 stem cell stories that have appeared in the paper by just going to this link. The package goes back to Jan. 4 and also includes editorials, another useful feature.

Tuesday, June 07, 2005

Public Posturing, the "Trust Us" Position and Industry Ties

The face-off Monday between the California stem cell agency and California's most influential legislator on stem cell matters does not appear to have resolved much, at least based on news reports.

Something could be bubbling below the surface, but it is not making much of a ripple yet.

At the Monday meeting, Sen. Deborah Ortiz, D-Sacramento, argued that the agency should support her measure. Oversight Committee members were not impressed.

Reporter Dan Morain of the Los Angeles Times quoted Caltech President David Baltimore as saying, "I don't know what her motivation is. But I know the result is extremely dangerous and could undermine the whole reputation of the state as a leader in stem cell research."

Ortiz said she will press forward with a vote on SCA13 later this week. But, according to Morain, Ortiz pledged that if the Legislature's attorney or state bond attorneys tell her she is "jeopardizing bonds, or my criteria and language is too vague and will encourage litigation, I will not move the measure forward."

"I'm driven by that, but it has to be based on the attorneys I'm working with," Ortiz said.

Reporter Carl Hall of the San Francisco Chronicle wrote, "Ortiz said she hasn't ruled out the possibility of withdrawing her proposal if the stem cell institute makes the right moves, and she repeatedly promised to make any changes that are needed to clear up worries about bond issues."

The public events predictably involved some posturing on both sides. Whether a compromise can be worked out is difficult to tell from this perspective.

The Oversight Committee says SCA13 is a life-and-death matter so Ortiz should back off. The same argument can said for its stance. Intransigence by the board certainly is a major element in keeping this whole issue alive.

The merits of the agency's "trust us" position goes only so far. California history is replete with examples of agencies that were or are little more than handmaidens of the industries they are supposed to regulate or are connected to in some fashion. The board that oversees physicians is one example, although it has improved in the last 10 or 20 years. Agriculture is another example of an agency that is a captive of its industry, which is one of the largest in California. The real estate department is still another.

The stem cell agency already has built-in ties with its industry. Those links are likely to grow in coming years. It behooves the Oversight Committee to at least assure disclosure of basic information about such connections, one of the matters that the Ortiz legislation concerns.

As for the argument that scientists would turn away from stem cell research grants because of economic disclosure requirements -- give us a break. Certainly a few might, but these are likely to be folks whose industry ties are dubious. Venture capitalists have long been successful at compelling entrepreneurs to surrender to the most onerous demands. The lure of $3 billion is likely to overcome the reluctance of any sensible scientist.

Here are related links to SCA13: Sacramento Bee story by Kevin Yamamura, the latest CIRM analysis of SCA13(June 1 version of the measure).

In separate items below is information from Ortiz' office that is not available on her web site.

SCA13: Ortiz Statement

The following is from Sen. Ortiz' office and was not available on her web site this morning.


SENATOR ORTIZ’S STATEMENT ON SCA 13
SACRAMENTO – Senator Deborah Ortiz (D-Sacramento) today issued the following statement after addressing the Independent Citizen’s Oversight Committee regarding Senate Constitutional Amendment 13:
“I introduced Senate Constitutional Amendment 13 with one purpose: to strengthen Proposition 71 regarding conflicts of interest and financial disclosures, ensuring public accountability and open participation in the $3 billion, taxpayer-funded California stem cell research program.
“I have had numerous conversations and meetings with stem cell research advocates, officials with the California Institute for Regenerative Medicine, members of the Independent Citizens Oversight Committee, medical and scientific experts, and both tax and bond counsel.
“We have made progress in crafting a measure that will provide full accountability and ensure the public’s confidence in the integrity of the system. I have been working with legislative and bond counsel to ensure that SCA 13 will do nothing to jeopardize the ability of stem cell research to proceed or hamper the state’s authority to issue tax-exempt bonds. Under SCA 13, California will continue to attract the best and brightest scientists and researchers, protecting their legitimate privacy concerns while making sure that research grants they recommend for funding are the best proposed projects.
“The only remaining issue is how we secure a strong commitment from the ICOC to deliver the therapies and drugs developed through stem cell research to Californians who face catastrophic illnesses and huge medical and prescription drug expenses. Despite its promise, Proposition 71 as currently written does not provide a way to ensure the results of stem cell research are made affordable and accessible to California’s health programs and needy residents.
“I urge members of the ICOC to continue working with me to ensure Proposition 71 delivers on its promise while protecting the taxpayers’ investment. California is the venture capitalist in this bold endeavor. The state’s residents are funding the research; they should have access to the cures that are developed as a result of their generosity and their hopes.”
# # #

SCA13: Ortiz' Summary

The following is from Sen. Ortiz' office and is not available on her website:

SCA 13 (Ortiz and Runner)
Prop. 71 Open Meetings, Conflict of Interest,
and Patenting and Licensing
Fact Sheet
SCA 13 would strengthen the public accountability provisions of Proposition 71, the Stem Cell Research and Cures initiative, by ensuring that principles of open government, protections against conflicts of interest, and the taxpayers’ interest are fully incorporated in decision-making under the initiative.
In passing Proposition 71, voters have entrusted the state with managing $3 billion in new funds for stem cell research. The cost of repaying bonds with interest will range up to $6 billion.
While Proposition 71 contains provisions concerning open meetings, conflicts of interest, and handling of royalties and intellectual property rights, as drafted and as they are being implemented by the ICOC, they do not go far enough to fully protect the state's interest. For example:
The initiative and the implementation of it explicitly exempts some Proposition 71 working groups from open meeting requirements, even when they consider broad policies and standards. These are expert groups whose recommendations will carry enormous weight, and are unlikely to be overturned by the governing committee.
The initiative and the ICOC’s implementation of it fail to require disclosure of economic interests by working group members, and instead relies on self-certification of conflicts of interest.
Regarding patents and licenses associated with research funded by Prop. 71, the initiative simply requires the ICOC to balance the interests of taxpayers with those of ensuring that important research moves forward, instead of ensuring therapies and treatments resulting from Prop. 71-funded research are accessible and affordable.
What SCA 13 Does
SCA addresses these problems by:
Applying open meeting standards to all deliberations of the ICOC and its working groups, with exceptions as necessary to conduct scientific peer review and to protect proprietary or scientific prepublication information;
Allowing an opportunity for public comment on the basis for approval or denial of applications for funding before recommendations for funding are submitted to the ICOC;
Requiring working group members to disclose to the ICOC relevant economic and property interests and to adhere to NIH economic conflict of interest standards, and requiring the State Auditor to periodically review the ICOC’s monitoring and enforcement of conflict of interest provisions for working group members;
Requiring the ICOC to seek to ensure, in negotiating intellectual property agreements, that therapies and treatments resulting from inventions and technologies developed with Prop. 71 funding are accessible and affordable to low-income residents, including those eligible for state and county-funded health care programs.
Proposition 71 gives California an opportunity to realize the enormous potential represented by stem cell research. SCA 13 simply ensures that Prop. 71 funding decisions are reached and carried out in a publicly accountable manner.
Organizations in Support
Californians Aware
CALPIRG
Common Cause
California Tax Reform Association

SCA13: Current and Planned Amendments

The following is from Sen. Ortiz' office and is not available on her website:


SCA 13 (Ortiz) – Current and Planned Amendments
Issue
SCA 13 as Amended 5/31/05
Planned Amendments
Open Meetings
--ICOC and Institute
Meetings of Institute and ICOC subject to California open meeting laws, with exceptions permitted under the Bagley-Keene open meeting act, consistent with Prop. 71 as drafted.
Clarify that the ICOC may consider matters involving patient information, confidential intellectual property or work products, matters involving prepublication, scientific information or data, and matters involving personnel, and that records including such information are exempt from public disclosure.
--Working Groups
Allowed to conduct closed sessions to conduct peer review, including to evaluate and score individual projects, and to consider matters involving intellectual property, proprietary information, and prepublication scientific information.
Grants working group required to produce a written summary of its reasons for funding or not funding any project as well as how each project recommended for funding will benefit California residents. it would also be asked to conduct an open public meeting to solicit public comments before submitting recommendations to the ICOC.
Written summaries could be posted on the Institute’s website, with an opportunity for the public to post comments, in lieu of holding a public meeting to invite public comment.
Public summaries of projects limited to a short description of the project, the disease category addressed by the project, the geographic region represented by the project, and the general reasons for the decision to fund or not fund the project. Intent is not to identify individual applicants or to publicly air the specific weaknesses of their proposals.
Conflicts of Interest
--ICOC members, Chair, Vice Chair, President of Institute
Required to file form 700’s and disclose their economic interests in the manner set forth in the Political Reform Act, as currently required in prop. 71
Required to divest or place in blind trust any financial or real property interest in any organization that applies for funding or that has substantial interests in stem cell therapy, defined as greater than 5 percent of its research budget.
Delete the divestiture requirement for ICOC members, Chair, Vice Chair, and President, and instead rely on the existing PRA disclosure and recusal requirements, or narrow the divestiture requirement to financial investments in designated entities.
--Working group members
Required to file form 700s and disclose their economic interests to the ICOC.
ICOC would provide the State Auditor with the disclosure statements. Auditor would be required to annually review disclosure statements as well as decisions or recommendations of each working group member and report findings to the Legislature regarding whether working group members have complied with requirements.
Apply the NIH requirement that members must recuse themselves from deliberation on any proposal if they or a close relative or professional associate has a financial interest in the proposal, including a direct benefit of any type deriving from the proposal itself, or a financial benefit of any type from an applicant institution of over $5,000 per year, including honoraria, fees, stock, or other benefits.
Narrow the scope of disclosure for working group members, perhaps to reporting interests (investments and income) in entities doing business with the institute and in biotech and pharmaceutical companies.
Intellectual Property
Requires grants and contracts to ensure that clinical treatments resulting from the research are made available at affordable costs to low-income residents and that the state is provided with a share of the royalties or revenues derived from the development of the treatments or services.
Delete the “except as otherwise provided in this article” language in section 6 of the bill, to make it clear that any conditions imposed by the bill are not conditions on the sale of the bonds themselves.
Delete the specific criteria in section 9 in favor of a broader policy statement requiring the ICOC, in negotiating intellectual property agreements, to ensure that therapies and treatments resulting from research funded by Prop. 71 dollars are affordable and accessible to California residents, particularly those eligible for state and county funded programs. This will remove grounds for litigation of individual projects and focus IP agreements in areas that produce the greatest benefits for taxpayers and do not jeopardize the ability to use tax-exempt bonds.

Monday, June 06, 2005

Cash Rolls In, Contracts Roll Out

The California stem cell agency has some good news today – a $5 million grant from the man responsible for Dolby sound on recordings.

Both The Sacramento Bee and the San Francisco Chronicle reported the donation this morning. Stem cell chairman Robert Klein
told reporter Carl Hall of the Chronicle that "the $5 million will be used to hire the legal, scientific and intellectual-property staff needed to proceed with the first grant programs, while the institute also pursues a $100 million short-term bridge financing plan."

"In a news release planned for today, Klein said, 'The Dolbys are fascinated by the possibility of a significant advancement of medical science through regenerative medicine research,'" Hall reported. The grant comes from both Ray Dolby and his wife, Dagmar.

The agency has run through about half of its $3 million startup loan from the state and will run out of money in November if it does not receive additional funds.

Reporter Laura Mecoy of The Bee wrote that the agency has signed contracts worth $1.1 million with private firms, including lobbyists and lawyers, and has more in the works. She said that Klein could recall only one that was competitively bid: an executive search firm's contract.

Mecoy continued, "While most other state agencies must solicit bids on contracts worth $4,999 or more, Klein said the institute doesn't have to go through the bidding process for its personal-services contracts.

"He cited a little-known provision of Prop. 71, the initiative that created the institute, that exempts the stem cell institute from competitive bidding requirements for such contracts.

"He said it's based on a University of California exemption that gives health-related agencies the leeway to contract with those with specialized knowledge.

"He contended that each of the contracts, including one being negotiated for the Edelman public relations firm, required such specialized knowledge."

Chronicle reporter Hall said that the University of California has loaned the stem cell agency staff assistance in human resources and hiring. It was not clear whether the agency would repay UC, which has its own financial problems, for the help.

For more on Edelman, see the "Hello to Edelman" and "Edelman Blog" items on April 22. For more on the contracts, see "$10,000 Lobbyist" May 5.

Sunday, June 05, 2005

CIRM Battling on Wrong Turf

From the White House to India, readers around the world on Sunday were told of the travails of the California stem cell agency.

"A battle for control of the $3 billion in research money voters approved last year has unraveled the alliance and threatens to hinder the California Institute for Regenerative Medicine even before it awards its first grant, agency officials say."

That was the second paragraph of a 788-word story by biotechnology reporter Paul Elias of The Associated Press. The story was circulated globally by the news service.

The story primarily focused on the battle over SCA13, the proposed ballot measure to tighten oversight of the agency. Pretty familiar ground for readers of this blog, but new to most others.

What makes this important for the agency is the continuing drumbeat of negative coverage nationally and internationally. While Elias' piece was straightforward, its overall impact was not good for the agency. It should instead be generating coverage of accomplishment and good works.

CIRM is fighting a PR battle on its enemies' turf instead of building on the considerable good will coming out of last fall's election in which 59 percent of the voters approved creation of the agency. It is time for the agency to do what is necessary to defuse the major issues so that it can move beyond the corrosive criticism that is eroding its effectiveness.

That also seems to the sentiment of at least one member of the stem cell Oversight committee, Dr. Francisco Prieto. He told Elias that he hopes a compromise can be reached soon on SCA13.

"I think the approach we have taken as a board has been more confrontational than it needs to be," Prieto said.

For more on the long range impact of the proposed ballot measure, see the "Vote Again..." item April 15 on this blog.

Is CIRM Truly Transparent?

Count the reasons why the California stem cell agency should be more open to the public. There are 75,027 of them.

At least that's a start.

Take 27 of them first. The agency noted with some pride last week that 27 California institutions have expressed an interest in an important training grant program to create a cadre of stem cell researchers. Most of them are undoubtedly public or nonprofit universities, colleges or nonprofit organizations, such as the Salk Institute.

But will California taxpayers ever learn the identity of these institutions, except for the handful ultimately selected? Not according to CIRM, which rebuffed a request for their identities because the grants are ostensibly being handled by a "working group." Those are entities linked to CIRM but whose records are closed to public view.

This is a level of secrecy that exceeds that of the California's governor's office. For example, the governor's daily schedule is a public record. We can learn who he met with and the subject of meetings. Not so with working groups, apparently.

The names of the 27 institutions are a relatively minor matter, but one wonders what other information is or will be cloaked in secrecy, despite the promises by the agency to set the highest standards of openness and transparency.

Now for the 75,000 other reasons. That is the national number of "expert clinicians and researchers (who) now consult for hedge funds, stock analysts, venture capitalists or other sophisticated investors." So reports a study published last month in the Journal of the American Medical Association, which was critical of the practice.

"That's up from 15,000 doctors who consulted in 2002, and fewer than 1,000 in 1996," wrote reporter Luke Timmerman in the Seattle Times, in a piece about the study. That amounts to one in 10 physicians nationwide.

While the study did not deal directly with stem cell research, it indicated the growing scope of the problem of ethical behavior involving medical affairs and research. Critics of the stem cell agency want broader public disclosure of the financial interests of key personnel. "But that's not the way it has always been done" is the thrust of CIRM's position. More aggressive disclosure will drive scientists away from the $3 billion research pool, CIRM contends.

Times have changed, however, as the AMA article points out. In less than 10 years, tens of thousands of physicians have begun to engage in activities that the editor of the AMA Journal now finds "hard to believe."

The AMA article dealt primarily with the private sector. CIRM is handling public money. While there is clearly a need for protection of proprietary information, personnel matters and other such information, the public deserves more, rather than less disclosure of CIRM's most sensitive workings.

Ortiz To Address CIRM Monday Morning

The California state senator behind the proposed ballot measure to tighten oversight of the California stem cell agency will appear before that agency on Monday.

Sen. Deborah Ortiz, chair of the Senate Health Committee and the most influential state lawmaker on stem cell issues, was invited on Thursday to speak to the Oversight Committee Monday morning in Sacramento.

The committee scheduled the meeting for Sacramento so that it could lobby against Ortiz' proposed constitutional amendment, SCA13, which may be taken up this week by the full Senate.

The board unanimously opposes the measure.

Ortiz' appearance poses an interesting contrast to the position taken by stem cell chairman Robert Klein, who refused to testify before an unusual joint hearing of the Senate and Assembly Health Committee into the new agency and related stem cell issues.

For more on Klein's refusal, see the following items on this blog: "Missing Man" March 15, "Roiling Undercurrents" March 16.

The Bridge Loan Plan: A Few More Details

Facing the possibility that it will run out of funds by this fall, the California stem cell agency on Monday will push forward with its "bridge financing" proposal.

Up for consideration at the Oversight Committee meeting in Sacramento is the bridge loan plan along with unspecified other financial possibilities.

CIRM has developed the plan because its normal ability to issue hundreds of millions of dollars in bonds is severely restricted pending the outcome of a lawsuit that challenges the existence of the new agency.

A report prepared by the agency's staff said that two law firms have indicated that the legal challenge is "meritless." The report also contains more details on the legal counter to the lawsuit including legal citations.

The agency proposes to borrow millions from philanthropic groups with the funds either going to the state or "to universities and non-profit research institutions that the Institute has selected to receive research grants." Donors would not be eligible to be grant recipients. The loans would not be paid back if Prop. 71 is overturned.

"We are meeting with the staffs of the Treasurer, the Controller, the Attorney General and the State Director of Finance to ensure that all of the constitutional officers responsible for the state’s finances and its legal obligations concur with this proposal. As those meetings proceed, we are working with the staff for the Treasurer and the Attorney General to draw up appropriate loan documents," the CIRM staff report said.

State Treasurer Phil Angelides on May 10 indicated he would hold a hearing into the matter within a month or so. However, no date has been set for that hearing.

Thursday, June 02, 2005

Competition for Creation of a Stem Cell Cadre

Twenty-seven California institutions are competing for a share of the first $45 million in grants from the California stem cell agency. It is a contest that will not attract the headlines of the HQ battle but one that is far more important.

The grants, which would be the agency's first, are aimed at creating a cadre of stem cell researchers in California who will push their research into clinical applications. Some grants could range as high as $1.25 million each annually to support as many as 16 "CIRM scholars."

The total of $45 million is expected to be spread out over three years among 18 universities, non-profit academic and research institutions with the first grants being awarded possibly as early as September.

"We are delighted at the robust response to our first call for grants. California’s next generation of scientists and clinicians is clearly eager to begin training for stem cell research and the development of new therapies for disease,” said Zach Hall, CIRM’s interim president. “These grants will create a vital foundation for future stem cell research in California.”

The agency's press release said that the grants are designed to encourage "institutions to create programs in which basic and clinical scientists are trained together in order to promote the flow of information from the laboratory to the clinic. Institutions are also required to offer a course in the social, legal and ethical implications of stem cell research as part of their curricula."

The agency envisions a three-tiered program with both large and small insitutions participating. Here is how CIRM described them.
  • A "comprehensive training program will educate at the pre-doctoral, post-doctoral and clinical levels. A Type I institutional grant will support up to 16 CIRM Scholars and operate on a total budget of up to $1.25 million per year.
  • An "intermediate training program will offer training at two of the three levels of education mentioned above. Type II grants may support up to ten CIRM Scholars at a given institution with a total budget of $800,000.
  • A "specialized training program will fund up to six CIRM Scholars at a total budget of $500,000."

The grants are aimed at educating students from "scientifically diverse backgrounds—including the relevant fields of biology, clinical training programs, bioengineering, as well as ethics and the law," the agency said.

"Because of the diversity of the California population, CIRM is particularly interested in training a diverse pool of investigators, including under-represented minorities, as CIRM Scholars and Mentors," the agency said.

The institutions, whose names were not immediately available, filed letters indicating their interest in the CIRM training program. The actual grant applications are due July 1.




How to Criticize This Blog and Other Matters

A couple of notes on how to use this web site.

Many of you have e-mail programs that can be used to automatically subscribe to the California Stem Cell Report. For example in Mozilla Thunderbird, you can do that by clicking on "subscribe" under the "file" command. Or you can use something called Bloglines. That is a free service that will handle multiple subscriptions and alert you automatically when new material is available. There are other ways to deal with subscriptions, which are known as RSS, Atom or Site Feeds. Here is a link to an article that will tell you more.

For those of you want to comment on an item, criticize this blog or praise or criticize the stem cell agency, you can do so directly on this blog. When the muse strikes you, click on "comments," which appears after each item. Your prose will be posted, untouched by human hands.

SCA13 Delayed, SB18 Advances to Assembly

Legislation requiring a performance audit of the California stem cell agency and creating protection for egg donors swept through the Senate on a 37-0 vote. However, a vote has been delayed at least until sometime next week on SCA13, the measure to tighten oversight of the agency.

The audit measure, SB18 by Sens. Deborah Ortiz, D-Sacramento, and George Runner, R-Antelope Valley, would require the State Auditor to conduct a performance audit of the California Institute for Regenerative Medicine and the Independent Citizen’s Oversight Committee. The first audit report would be due to the Legislature by June 30, 2006.

The bill also would restore patient protections for egg and embryo donors by: requiring physicians to provide donors with a written summary of health impacts associated with human oocyte production, requiring donors to give written consent before donating oocytes for purposes of research, placing limits on the sale or transfer of human oocytes or embryos and limiting compensation to women to encourage them to produce human oocytes for the purposes of medical research.

The bill encourages the ICOC to commission and undertake research into the health impacts of ovarian stimulation drugs used in assisted oocyte production, according to Ortiz' office.

It now goes to the Assembly for further consideration.

More Job Openings at CIRM

Need work? The California stem cell agency is looking for a few good persons. The latest openings are posted on CIRM web site. They range from the president's job, which should be filled shortly, to the executive assistant to the "chair," which probably is really the chairman instead of piece of furniture.

Oddly, the notices do not indicate a pay range, although previous openings have been filled at salaries that some critics said were too high.
The executive assistant positions require typing, formating and proofreading documents. For those tasks it seems a four-year college degree and "four years of executive assistant experience supporting high level leaders or an equivalent combination of education and experience" are necessary. Admittedly the position has other, more significant responsibilities, but it seems a tad inefficient to have such a highly qualified person doing clerical work. Here are links to the job descriptions.
President, California Institute for Regenerative Medicine (pdf)
Scientific Program Officers and Scientific Review Officers (pdf)
Senior Officer for Medical & Ethical Standards (pdf)
Executive Assistant (pdf)
Executive Assistant to the Chair (pdf)

(Forgive my comments re the "chair" but expression remains an abomination. Next we will see a sentence that goes something like: "The chair impacted the agency's infrastructure." Yuck.)

Wednesday, June 01, 2005

Patient Group Members Mobilize Against SCA13

Members of patient groups are barraging legislators with appeals to reject efforts to tighten oversight of the California stem cell agency. Some of the appeals are being couched in life-and-death terms.

The outpouring was predictable given the deep ties that the agency has with the groups, whose members hope to benefit from future therapies developed by research financed by the agency. A number of the members of the stem cell Oversight Committee come specifically from patient groups. The agency undoubtedly has lists of supporters as well. The allied nonprofit organization that grew out Prop. 71 campaign committee also is likely to be involved in the lobbying campaign, as it was earlier this year.

One email sent from a CIRM address by a CIRM staffer to a group of sympathizers was basically an informational pitch. It did note that the Oversight Committee thought SCA13 would have a detrimental effect. The email included attachments from a number of organizations concerned about SCA13, including the University of California, Stanford, USC, Caltech and the Salk Institute. It also included the agency's critical analysis of the legislation. But the email did not advocate that the recipients take a position or lobby legislators.

We should note that out of the six documents attached to the email, only one has been accessible to the general public in a posting on CIRM's web site.

In response to a question about lobbying on SCA13, Nicole Pagano, a spokeswoman for CIRM, said, "Those advocates who contact us receive information as any member of public would. ICOC members who are patient advocates like Joan Samuelson and Jeff Sheehy may attempt to educate their own communities and constituencies because they are opposed to SCA13 as currently drafted, but CIRM staff is not engaged in mobilization campaign efforts."

The measure is expected to come up for a vote on the Senate floor either Thursday or Friday.

If readers of this blog are interested in receiving copies of the items attached to the CIRM email, please send a note to me at djensen@californiastemcellreport.com. I will send them along to you.

Californians Need Information Not Ballyhoo

Are Californians going to have a chance to genuinely see what the California stem cell agency is going to deal with at its meeting this month in Sacramento?


With three business days left before the meeting on Monday, the agency has posted only a laundry list of items on its web site. The subjects on the list are certainly important, but the information about them is limited to a word or two or a phrase.


We do know the following. Changes are being considered on the agency's conflict of interest code. The Oversight Committee is scheduled to discuss temporary financing measures that will prevent it from running out of money this fall. A proposed ballot measure that would create an electoral donnybrook, also this fall, is up for consideration. Appointment of real estate specialists to a stem cell working group is another topic. Also on the table is a six-month review of the agency. Actually this preceding summary of the agenda contains more information than the actual agenda items themselves.


In past months, the agency has posted background material – usually quite late -- on a few items scheduled to be brought up at the monthly meeting – not a lot but some. However, in May, the agenda for the Oversight Committee was nothing more than a list. The public was out of luck if it wanted to have any reasonable idea of the nature of the issues to be discussed.


As we have noted in the past, even the lowliest school district in California does a better job of informing the public in advance about its meetings.


The stem cell agency has ballyhooed its commitment to openness and transparency. But its actions tell a different story.

Search This Blog