First Chance for Business to Snag California Stem Cell Dollars

Attention Stem Cell Businesses! California's $3 billion wagon of cash is moving fast, and it is now time for you to jump on board.

The California Institute for Regenerative Medicine is looking for a few good businesses, and it wants to give a few million dollars to them. Even if you are headquartered in New Jersey or anywhere else in the world, it makes no difference. Only a couple of catches – you must have a "research site" located in California by Feb. 5. That site is also where the CIRM-funded research must be done.

Feb. 5 is the deadline for applications for a $25 million round of grants for research into development of new cell lines, both from IVF and alternative methods such as reprogramming. Sixteen grants are expected to be awarded with funding possibly as early as August of next year.

This is the first opportunity for businesses to seek grants from CIRM. It appears that they will be competing for stem cell dollars against academic and nonprofit researchers. It is hard to set the odds on the competition given the array of stem cell talent in the Golden State. But some CIRM directors are eager to pump money into the private sector, figuring that could pay off by developing therapies faster than going the academic route. Others are simply sympathetic to the needs of cash-starved stem cell enterprises.

The news about business grants was buried deep in the new cell lines RFA that CIRM posted with no fanfare last Thursday. John M. Simpson, the stem cell watchdog for the Foundation of Taxpayer and Consumer Rights, was quick to see it. (We also wrote about it for Wired.com in a piece that appeared Friday evening.)

Simpson issued a news release on Friday afternoon noting that biotech companies play an important role in stem cell research. But he also said that CIRM should not be in the business of writing blank checks for biotech. Simpson declared,

"We’ve already seen an example of an improper attempt by a stem cell board member to influence an award to his non-profit research institution. The possibility of abuse is even greater when the biotech industry goes after the money.”

Simpson has been active in development of intellectual property policy of the the stem cell agency, which is the key mechanism for the state to share any wealth that may result from CIRM-funded research. It is also the mechanism for assuring affordable access to CIRM-backed therapies. On Dec. 12, the agency's directors are expected to approve its IP policy for grants to business. Businesses can still weigh in with comments ahead of the meeting or at the meeting itself. Our advice is to do both, if it is important to your enterprise.

The exact IP policy that is to be considered is not yet posted as part of the agenda for the meeting, but the RFA has a link to this related document.

The reprogramming effort should come as no surprise to those who follow the agency closely. Arlene Chiu(see photo), former chief scientist at CIRM, and others were working on the new cell line proposal, including the reprogramming aspects, well before the news surfaced last month about a breakthrough in creating pluripotent cells from adult skin cells.

In October, she presented the concept for the new cell line grants to CIRM directors, declaring,

"We want to support the full spectrum of human pluripotent stem cell types and experimental approaches."

Also open to businesses is a $1 million round of planning grants to help lay the foundation for awards in a much larger series of "disease team" grants. That round will total roughly a whopping $122 million. In the case of planning grants, the RFA states that "for-profit organizations in California" may apply, but it does not specify whether they must be headquartered in the state or simply have operations in California.

Here are the key dates for the planning grants: Candidate nomination forms and letters of intent, Dec. 20; applications Jan. 31.

Key dates for the new cell grants: Candidate nomination forms and letters of intent, Jan. 10; applications, Feb. 5 as noted previously.

California's Widening Stem Cell Net

Will Wisconsin scientist Jamie Thomson and Japan's Shinya Yamanaka be ripe for a research grant next year from the California stem cell agency? And perhaps others as well who are located principally outside of California?

CIRM's $3 billion research effort appears to be moving in that direction in its latest RFA for new cell lines, including reprogramming efforts.

For those of you who may have been tuned out last month, Jamie Thomson of the University of Wisconsin and Shinya Yamanaka of Kyoto University in Japan, generated international hoopla with their reports that they created pluripotent cells out of adult human skin cells.

Both men did their work outside California, which made them ineligible for funding in the Golden State.

But Thomson is now affiliated with the University of California, Santa Barbara, which has ponied up $1 million to support him at the seaside campus. And Yamanaka is linked to Gladstone Institute in San Francisco. Both men are part of a wave of about 50 stem cell scientists who have come to California since the stem cell institute was created three years ago.

If the money were right, both would seem to be able to meet the CIRM requirement for the grants for the new cell lines that they make a "10 percent effort" on research in California. Other scientists are likely to be able to meet that requirement as well.

The CIRM Oversight Committee indirectly touched on the question of funding such folks as Thomson and Yamanaka at its meeting in October. Neither Thomson nor Yamanaka was mentioned by name. But at one point, Philip Pizzo, dean of the Stanford School of Medicine and a member of the Oversight Committee, asked CIRM staff,

"What if there's an investigator who comes to California for part of her or his work who has an appointment in another state, let's say Wisconsin as a hypothetical, who develops new stem cell lines. and because of an academic affiliation seeks to have those said lines become part of, for example, the Wisconsin policy?"

Pizzo later remarked,

"We would welcome joint appointments or other appointments that would bring new talent to California, recognizing that the individual may be at another place, but I think we just have to understand -- the legal folks will need to understand what that means in terms of institutional controls over IP as well."

The upshot of the discussion seemed to be that the IP would belong to the institution where the research was conducted, and it would be in California. But no legal opinion was rendered by CIRM or policy position taken.

During a later discussion of disease team grants, California stem cell Chairman Robert Klein made it clear that "there is the intent to capture these brilliant scientists who are prepared to make a part-time commitment to California, paying for the time they spend in California."

All of this fits with the aspirations of incoming CIRM President Alan O. Trounson, an Australian who has said broadening the reach of the agency is one of his goals.

SC3: The New California Stem Cell Collaboration

Six California research institutions, ranging from the University of Southern California to the University of California at Santa Barbara, today announced a "collaboration" aimed at enhancing their stem cell research efforts.

Martin Pera(see photo), director of the USC Center for Stem Cell and Regenerative Medicine, said,

"Tackling these complex problems requires scientists with diverse expertise. We are delighted to have an opportunity to work with such an outstanding collection of scientists to really accelerate the pace of discovery and translational research in regenerative medicine."

In addition to USC and UC Santa Barbara, the other institutions are Childrens Hospital Los Angeles, City of Hope, the California Institute of Technology and the House Ear Institute.

The coalition is officially known as SC3 – the Southern California Stem Cell Scientific Collaboration.

SC3's news release said,

"The new agreement is a major step forward in supporting potential significant stem cell findings by allowing members to share training programs, scientific core facilities and expertise while teaming up on a wide range of research programs."

Dennis Clegg, director of the stem program at UC Santa Barbara, said, "The SC3 collaboration is already engendering new ideas for collaborative projects between scientists at the participating institutions."

Pera said SC3 is not applying for any of the $227 million in CIRM lab construction grants, which are being reviewed privately today in San Francisco, although USC is. Pera said via email,

"We have dedicated one floor in our proposed facility (Edythe and Eli Broad Center for Regenerative Medicine and Stem Cell Research) to supporting the work of SC3-through training, access to core laboratories with specialized equipment and expertise, and through providing space for collaborative and pilot projects. "

Southern California already has another type of collective effort underway regarding stem cell research – the San Diego consortium involving UC San Diego, Scripps, Burnham and Salk. However, it appears to be more formally structured and is believed to be seeking a large lab construction grant from CIRM.

The stem cell agency has declined to identify any of the institutions seeking grants.

CIRM Media Coverage: Conflicts to Anachronisms

A spate of articles has surfaced in the last couple of days concerning the $3 billion California stem cell agency, conflicts of interest and a new state audit of three-year-old effort.

Here is a quick rundown.

Sacramento Bee -- An editorial today praised the audit ordered by state Controller John Chiang. The first paragraph of piece said,

"Why is California's quasi-public stem cell research institute mired in questions over expenditures and backdoor lobbying? Part of the blame falls to the state's lawmakers and constitutional officers, who have failed to conduct proper oversight of this $3 billion agency."

San Francisco Chronicle opinion piece today – Written by Jesse Reynolds of the Center for Genetics and Society, it said,

"The shortcomings at CIRM run deeper than a handful of individuals. Proposition 71 not only vested governance of $3 billion in public money in those who seek to maximize their own share, but it is riddled with exceptions to the norms of public oversight, accountability and transparency. In this context, last week's development is an unfortunate but predictable result."

Reynolds also wrote a similar piece on his
his organization's blog, the Biopolitical Times.

The Niche (stem cell blog of Nature magazine) – Monya Baker attended Tuesday's meeting at which the audit was announced. She wrote on Nov. 27,

"Before and after the meeting (John M.) Simpson (of the Foundation for Taxpayer and Consumer Rights) and (California stem cell Chairman Robert) Klein could be seen talking spiritedly to each other, but they did not seem hostile. In conversations I overheard, one committee member told Simpson that CIRM members shouldn’t be expected to have the savvy of public officials. Klein told Simpson that lives could be lost if research was prevented, and Simpson said repeatedly that those entrusted with public funds need to be held accountable with public scrutiny."

Wired.com – A piece by this writer on Chiang's audit order and call for a separate investigation into the attempt by CIRM Director John Reed to influence a grant to his organization, the Burnham Institute.

San Diego Union-Tribune -- Terri Somers reported on Nov. 28 on the Chiang audit and said that Reed and Klein both say they will not resign.

San Jose Mercury News -- Steve Johnson wrote on Nov. 27 that Klein said he welcomed the audit.

San Francisco Chronicle – An editorial Nov. 28 said,

"As if stem cell work wasn't challenging enough, California is making harder. The voter-backed Institute for Regenerative Medicine has encountered its own ethical trouble. A board member lobbied the stem cell research body to overturn a rejected research proposal from a colleague. It was an intolerable violation of ethical guidelines. Stem cell work both here and nationally must adhere to the highest standards."

Secondhand Smoke, blog by Wesley J. Smith, who opposes hESC – Smith today cited the Reynolds piece and said,

"The science climate has changed since the passage of Proposition 71 and its structural problems continue. In light of the new science breakthroughs and the continuing questionable decision making, perhaps it's time not to borrow billions of dollars for human cloning research in a state once again drowning in red ink."

IP Biz blog – Larry Ebert wrote,

"Klein and californiastemcellreport are fast becoming anachronisms."

Top California Official Orders Audit of State Stem Cell Agency

California State Controller John Chiang today ordered an audit of the $3 billion California stem cell agency, including its conflict of interest policy and compliance with state law.

Chiang made the announcement at the meeting of the Citizens Financial Accountability Oversight Committee, which is charged with reviewing the performance and finances of CIRM. Chiang, who is one of the state's top financial officials, is chairman of the committee.

Chiang also announced that he has sent a request to the state Fair Political Practices Commission that it investigate the attempt by John Reed, a member of the CIRM Oversight Committee, to influence a $638,000 grant to his research enterprise, the Burnham Institute. Reed has since admitted his action was a violation of the agency's conflict of interest policy.

Chiang said in a news release,

"Whether they are perceived or real blemishes, we must resolve any conflict of interest questions quickly so we can protect the important and powerful work that is taking place in stem cell research."

The controller, a Democrat who was elected statewide, also said,

"Considering the institute has already made grants to 23 research agencies and the treasurer has sold $250 million in bonds for additional research, it is imperative that the research financing move forward in an ethical and transparent manner. Immediate action is necessary to guarantee the institute is effectively overseeing grants, and that grant recipients are using state funds appropriately and in a manner consistent with the stem cell initiative."

Chiang said that the audit will include how grants are allocated, whether the institute provides adequate oversight once the grants are awarded and what performance milestones are in place.

At today's meeting, John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, renewed his call for the resignation of Reed and Robert Klein, chairman of CIRM. Klein, an attorney, advised Reed to engage in his lobbying effort.

Simpson also called for more openness in the closed door review of the applications for $227 million in lab construction grants. That review begins tomorrow in San Francisco. Simpson said,

"As already demonstrated by Reed and Klein’s actions, the only way the public can have faith in the process that will dole out millions of taxpayer dollars is for there to be complete transparency, Apparently the stem cell agency is afraid that a university or research institution might be embarrassed if their application does poorly. What the overseers need to understand is that they are not running a private club. They are supposed to be stewards of public money. They need to act that way. When they don’t, there must be consequences."

Judge Dismisses Cha Libel Suit Against Flamm

The California physician who criticized Korean stem cell scientist Kwang Yul Cha has won a round in Cha's libel suit suit against him.

Earlier this month, a Los Angeles judge threw out the suit against Bruce Flamm of Riverside, Ca., but Cha has about 60 days to file an appeal, which a spokesman says he is considering.

Cha surfaced in connection with the California stem cell agency when a nonprofit subsidiary of his organization won a research grant from CIRM. After the grant was approved, the media reported its links to Cha along with news about the controversy surrounding some of Cha's research. In October, Cha's group withdrew its application for the CIRM grant.

In the case of Flamm, he published a critical opinion piece concerning Cha's 2001 study that linked prayer to in vitro fertilization success. Cha says Flamm is engaged in a personal vendetta.

Regarding the judge's action, Flamm told The Scientist on Nov. 20:

"This is a great victory for science, peer review and academic freedom."

Time to Shine More Light on CIRM

The California Stem Cell Report has sent the following letter to the Citizens Financial Accountability Oversight Committee, which is meeting today in San Francisco concerning the affairs of the state's $3 billion stem cell agency.

To the Citizens Financial Accountability Oversight Committee:

The time has come for the California Institute for Regenerative Medicine to open its doors to more public disclosure in the interest of greater public accountability and to avoid further damage to its reputation. Such a move would enhance its performance as a credible advocate for sound scientific research and help to prevent future scandals involving its $3 billion program. I am asking your panel to make such a recommendation to CIRM.

Within the last week, Californians have seen stories in the media concerning an attempt by a CIRM director to privately influence the award of a $638,000 grant to his institution. That attempt was made at the suggestion of the chairman of the CIRM Oversight Committee, Robert Klein, who is also an attorney. His advice was in clear violation of CIRM's conflict of interest policy, a fact that he now acknowledges. Disclosure of the lobbying effort, first reported by the California Stem Cell Report, has generated calls for the resignation of Klein and the director, John Reed of the Burnham Institute. One organization, the Foundation for Taxpayer and Consumer Rights, has filed a complaint with the Fair Political Practices Commission.

Klein's and Reed's actions are part of a larger issue at CIRM: the conflicts of interests that are built into its structure by Prop. 71 and which the California state auditor has touched on. For example, currently a majority of its directors (Oversight Committee members) are linked to institutions that could benefit from the $227 million in lab construction grants scheduled to be given out next year. And the Oversight Committee is the group that approved the criteria for the lab grants.

CIRM has refused to disclose the names of the institutions that have applied for the grants until well after they undergo the most important stages of their review, a move that makes it impossible for the public to comment properly. It is also a case of unnecessary secrecy that only fosters suspicion and the worst sort of speculation, particularly in light of Klein's and Reed's actions.

CIRM's justification for this secrecy is weak. It does not want to embarrass any unsuccessful applicants, all of which are major public and private nonprofit institutions. It is a policy that seems to have been adopted, without due consideration, from a similar policy regarding applications from individual researchers.

However, applications for the major lab grants are much different than those from the men and women who direct stem cell research labs. The applications for lab construction funds come from huge institutions such as the University of California and other major educational and research enterprises. Their names and applications should be part of the public record. Equating the sensitivities of UC Berkeley or other likely institutional applicants for lab grants to the sensitivities of an individual researcher would seem to defy common sense. And if proprietary information exists in the application, it can easily be excised before release.

In keeping with the sense of the state auditor's report, CIRM should also make public the economic disclosure statements of the persons who review the grants. Public disclosure of those documents will assure both scientists, whose applications are being reviewed, and the public, whose money is being spent, of the essential fairness of the process.

CIRM has resisted such disclosures. It says it is already more open than the National Institutes of Health. But CIRM and the NIH are not comparable. The president and Congress can and do intervene in NIH matters and set its budget. In California, the governor and legislature are barred, for all practical purposes, from exercising such oversight because of the provisions of Prop. 71. Even the tiniest alterations in CIRM require an unprecedented, super, super majority vote of the Legislature and signature of the governor. Its funding is continuously appropriated and not subject to the normal budget process. All that means that CIRM has a special responsibility to demonstrate accountability and show the public that is performing with their best interests in mind.

I urge you to recommend to CIRM that it identify forthwith the applicants for its upcoming round of lab construction grants and to release the statements of economic interests from its panels of grant reviewers.

Conflicts and Klein: Fallout From Bad Advice

The role of Robert Klein, chairman of the California stem cell agency, in the Burnham grant affair largely escaped significant public scrutiny until Sunday's editorial in The Sacramento Bee.

One does not want to minimize the responsibility of John Reed, a notable scientist and accomplished executive, who privately lobbied the staff of CIRM to give a $638,000 grant to his organization(the Burnham Institute) while sitting on the board of directors of CIRM. But all of that came at the advice of the chairman of the agency, Robert Klein.

In the eyes of many, Klein is the virtual public embodiment of the stem cell agency, a role he relishes. He claims authorship of Prop. 71. He led the $30 million campaign for its passage, working the media and speaking on television shows in California and nationally. He is so knowledgeable that he can and does quote legal code citations from Prop. 71 in public meetings. Fortune magazine once called him a "super salesman" for human embryonic stem cell research.

John M. Simpson, of the Foundation for Taxpayer and Consumer Rights and longtime CIRM observer, says that Klein "brought great entrepreneurial spirit and energy and deserves great credit for getting Prop 71 passed and the agency launched."

All of which makes the impact of his advice to Reed even greater. The fallout is likely to ripple throughout the scientific community, the legislature and the media. And not much of the fallout is good.

Obviously their actions are a great embarrassment to both men, at the very least. But the impact on the California Institute for Regenerative Medicine will be considerable and long-lasting.

Klein has played into the hands of the foes of human embryonic stem cell research, who love to conjure up demons who fiddle with funding and abuse the public trust. They now can simply point to Klein and Reed as proof.

Putting the foes aside, the men's actions also raise qualms about the stewardship of $3 billion in public funds among those who are on the fence on the issue of stem cell research, as well as among some of its fervent supporters.

So far, CIRM has beaten off attempts by California lawmakers to intervene in the agency's affairs. Now legislators have a fresh and serious justification to probe into the agency's $29,000-an-hour research funding effort. Some may say a little friendly oversight from Sacramento is healthy but that is not the official view of CIRM's Oversight Committee.

The Reed/Klein affair has also come to light at a time when some are contending that human embryonic stem cell research is unnecessary in light of the recent research news about other ways to reap its benefits without the untidy matters associated with hESC experiments. Some are already questioning the necessity of CIRM's efforts.

Internally, Klein's action nurtures any latent suspicions among Oversight Committee members that a rival institution represented on the board might be favored privately in some fashion. That is a development that signals a weakened leadership position for Klein himself.

Klein's advice concerning the Burnham grant is not the first time he has demonstrated an insensitivity to issues that others perceive as important ethically or simply as a matter of propriety. He has taken the unusual step, for a state official, of operating his own private lobbying group on stem cell research. Earlier this year, that group took a $125,000 contribution from a northern California land developer. A short time later, Klein lobbied on behalf of a land deal backed by that developer. Part of that deal called for Klein to head a new nonprofit stem cell research organization that would be created as a result. Early on in CIRM's life, he refused to testify before a state Senate committee into the implementation of Prop. 71. Later, he organized an Internet campaign against a state senator who was seeking higher office. He called her an "ongoing threat" to stem cell research, although she had been the chief legislative advocate for stem cell research for years.

It is difficult to understand what led Klein, an attorney, to give Reed the bad advice. Whatever the reason, the Oversight Committee is riddled with conflicts of interest, something Klein should be keenly aware of. More than half of its members have links to institutions that could stand to benefit from the upcoming round of $227 million in lab construction grants. And it was the Oversight Committee itself that set the standards for those grants – not some detached, third-party organization.

The Bee (see item below) called for changes in the Oversight Committee. But Klein's crafting of Prop. 71 has made it virtually impossible to make even the best-intentioned changes at CIRM. The measure requires a super, super majority vote of the legislature and the signature of the governor to enact the tiniest alterations in CIRM's structure.

The only practical answer to the concerns about the conflicts – embodied vividly in the actions by Reed and Klein – is for CIRM to open up its operations. Publicly disclose the names of institutions seeking grants, publicly disclose the financial interests of scientific reviewers who make de facto decisions on grants. Even more openness would desirable, but these are relatively easy steps at this point.

On Sunday The Bee called for Klein and Reed to resign. While acknowledging Klein's contributions to CIRM, Simpson says, "Now, particularly given his propensity to treat it like his own fiefdom, it's time for him to move on." Last December, Klein indicated he would be leaving his post in 2008. That currently looks unlikely. The reason? His proposal for a biotech loan program as large as $750 million remains far from fruition.

It is probably not too soon, nonetheless, for the Oversight Committee to begin to think about succession, a matter that is critical to any business or organization, but particularly to an enterprise involved in the new frontiers of science and its finances.

Reed vs. Klein: "The Bigger Problem"

A writer who prefers to be anonymous pointed out, regarding the item below, that The Bee also called for the resignation of John Reed from the CIRM Oversight Committee. Point well taken. The Bee also observed that Klein is "the bigger problem."

We had a bad link to The Bee editorial. Here is a good link.

Sacramento Bee: Klein Should Step Down

The Sacramento Bee said today that Robert Klein should step down as chairman of the $3 billion California stem cell agency, the largest source of funding for human embryonic stem cell research in the world.

The Bee's editorial came in the wake of disclosure that Klein(see photo), who is an attorney, advised John Reed, a member of the agency's board of directors and head of the Burnham Institute, to privately lobby CIRM staff for a grant for his institution in violation of the agency's conflict of interest policy.

The Bee said,

"More than anyone, Klein should have known that Reed's inquiries and letter were inappropriate and would put him in a precarious legal situation."

The newspaper continued:

"Klein, as we've said for some time, needs to step down. His divided loyalties, his disregard for public processes and his imperious nature have driven off institute staff and created a bunker mentality at what should be a world-class scientific institute.

"Beyond that, the Legislature needs to reorganize the oversight board, making it smaller and less rife with conflicts. Although stem cell research still garners wide support, taxpayers want assurance their $3 billion will be spent based on the merits of projects, not behind-the-scenes lobbying."

At least two members of the agency's board, which is called the Oversight Commmittee, have expressed public concern about the Reed's action. More are certainly to be concerned as well. A consumer watchdog group, the Foundation for Taxpayer and Consumer Rights, has filed a complaint with state officials concerning the Reed matter, which could lead to fines of both men.

For those of you not familiar with California media, The Bee is the dominant newspaper in the state's capital. It is widely read by legislators, state government officials and public policy analysts.

Two CIRM Directors Upset by Improper Action by Colleague; Watchdog Calls for Klein Resignation

Two directors of the California stem cell agency have expressed concern about an allegedly illegal attempt by a fellow director to influence a $638,000 grant to his own research institution.

Their comments were contained in today's coverage of the attempt by John Reed, which was first reported on this web site on Wednesday. The item generated stories today in San Francisco Chronicle, San Diego Union-Tribune and The Sacramento Bee, San Jose Mercury News and on a blog Wednesday for Nature magazine.

Jeff Sheehy, a CIRM Oversight Committee member, said that Reed, who is president of the Burnham Insitute, should consider resigning. Sheehy (see photo) told Sabin Russell of the Chronicle,

"We need to resolve this before questions are raised about the integrity of our processes."

Russell also reported that David Serrano Sewell, a San Francisco deputy city attorney and member of the Oversight Committee, was "upset" by Reed's action but stopped short of calling for his resignation. "Patient advocates understand the rules. I just wish John hadn't done what he did," Sewell said.

Some of the members of the 29-person Oversight Committee are appointed to what are known as "patient advocate" positions.

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumer Rights, previously had called for Reed's resignation. The Chronicle reported that Simpson is also now calling for the departure of Robert Klein, chairman of CIRM. It was Klein, an attorney, who advised Reed to write the letter in violation of CIRM's conflict of interest policy.

Today's news stories also carried the first comments from Reed and Klein. Both declined to respond initially to inquiries from this writer.

Reed told the Chronicle:

"It did not occur to me that conflict rules would prevent me from contacting staff to provide what I believed to be relevant information."

Klein described his actions as an "inadvertent error." He was quoted in the Chronicle as saying that although the letter was directly personally to Arlene Chiu, the chief scientist at CIRM, it was never seen by "the scientific team." He said,

"Our firewall worked. The influence didn't change anyone's mind, because the letter wasn't even considered."

However, CIRM documents obtained by the California Stem Cell Report show that Tamar Pachter, general counsel for CIRM, responded to Reed's letter in subsequent correspondence to Burnham by saying,

"Staff has considered the substance of the letter, and appreciates the time and thought that went into it..."

Simpson has filed a complaint with the state Fair Political Practices Commission concerning Reed's action. Terri Somers of the San Diego Union-Tribune said the commission could fine Reed or Klein up to $5,000.Reed's action. Terri Somers of the San Diego Union-Tribune said the commission could fine Reed or Klein up to $5,000.

Here are links to the Nature item and the Bee story. The Mercury News also carried a short item.

Text of John Reed letter

Here is a link to the complete text of the John Reed letter mentioned in the item below. It has been posted by John M. Simpson of the Foundation for Taxpayer and Consumer Rights. We were unable to post the material on the California Stem Cell Report because of technical difficulties here in Mexico.


Here is a link to the news release from foundation on the Reed letter.

Burnham's John Reed, Influence and a CIRM Grant Denial

In an apparent violation of a state conflict of interest policy, an influential director of the California stem cell agency earlier this year attempted to overturn a decision by the agency's staff that ultimately resulted in the loss of a $638,000 grant to his research institution.

John Reed, president of the Burnham Institute of La Jolla, Ca., on Aug. 2 wrote a 6 ½ page letter to the agency staff, warning that denial of the grant would set a "dangerous precedent" that would impair the mission of the California Institute for Regenerative Medicine (CIRM). The letter came about as the result of a suggestion by chairman of the institute, Robert Klein.

The California Stem Cell Report (CSCR) obtained a copy of the letter from Reed (see photo) from CIRM after filing a request under the state's public records act for documents relating to the Burnham grant.

In response to questions from CSCR, Richard Murphy, interim president of CIRM, said,

"Dr. Reed called the chairman to ask how to deal with what Burnham saw as technical mistakes in CIRM’s interpretation of the application. The chairman, not knowing enough about the technical details or whether mistakes had been made, suggested that Dr. Reed write a letter to the science team, which was knowledgeable about the issues."

Murphy also said,

"After CIRM received the letter, Dr. Reed was informed that he must refrain from participating in any way in CIRM's consideration of the Burnham grant."

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., called for Reed's resignation, declaring that he would file a formal complaint with the state Fair Political Practices Commission, which deals with conflict-of-interest violations.

Simpson, a longtime observer and participant in CIRM proceedings,said, "The law is clear....John Reed flouted the law." He continued, "When you hand out millions of dollars in public money, you have to play by the rules."

Asked whether CIRM contemplated any action regarding Reed, Murphy replied, "Dr. Reed now fully understands the conflict rules. CIRM does not intend to take any further action regarding this matter."

Klein did not respond to an email asking about his role in the Reed letter. Reed also did not respond to questions emailed to him.

Reed presides over a nonprofit research institution that has received $17 million in CIRM grants and that has an annual budget of $87 million. According to Burnham's web site, it has 750 employees and ranks 5th in the nation in NIH funding among private research institutions.

CIRM's policy on conflict of interest states:

"Members of the ICOC shall not make, participate in making, or in any way attempt to use their official position to influence a decision regarding a grant, loan, or contract with their employer.

"Members of the ICOC shall not make, participate in making or in any way attempt to use their official position to influence a decision regarding a grant, loan, or contract that financially benefits the member or the entity he or she represents."

The application for the grant in question came from David Smotrich, an adjunct professor at Burnham and founder of the La Jolla IVF clinic. The grant was highly rated by scientific reviewers, who examined it behind closed doors and made the initial decision to fund it. Their findings then went to the Oversight Committee for final action last February during a public meeting. The application was considered at that time under the board's normal procedures. The names of the applicant and institution were withheld from the public and the Oversight Committee. Reed was barred from voting and taking part in the discussion, but that fact was not known to the public at the time.

Following Oversight Committee approval, the Smotrich application and all other approved grants were scrutinized administratively to assure that they complied with terms for the grants. CIRM staffers did not question the science or the credentials of the researcher. But they indicated as early as Feb. 24, according to CIRM documents, that there were problems with the eligibility of Smotrich. The issues involved whether he was a fulltime faculty member at Burnham, was located on the Burnham site and whether he had his own dedicated lab at Burnham.

The exchange between CIRM and Burnham about Smotrich went on for seven months. The letter from Reed came just as CIRM staff was planning to announce the grant denial at the Oversight Committee meeting early in August.

He said in his "appeal" letter to Arlene Chiu, then the top scientist at CIRM, that Smotrich "rightfully deserves" the grant. He devoted the bulk of his letter to Smotrich's credentials and his research, which included an "embryo rescue program" that would salvage leftover embryos from IVF that would otherwise be discarded.

Reed wrote:

"I also wish to emphasize the potentially damaging consequences that a decision not to recognize Dr. Smotrich's legitimacy as a faculty member may have on clinician investigations, as it will surely discourage clinical researchers from participating in the CIRM mission to advance stem cell therapies. Finally, the particular grant recommended for funding is of great strategic importance to the entire CIRM effort, and therefore we urge CIRM staff to take this into consideration."

Referring to the "embryo rescue program," Reed said,

"This is a unique resource not found anywhere else in the entire state and the only source currently available in California for deriving new hESC lines with the goal to share these freely with the entire CIRM research community to advance the fundamental goals of CIRM. Thus, to abandon the grant on perceived technical grounds flies in the face of the mission of CIRM."

Reed added that denial of the grant "sets a dangerous precedent that adversely affects all clinician-scientists, most of whom will have a significant component of their time devoted to clinical activity and whom will often by supported by non-academic sources."

On Aug. 27, Tamar Pachter, CIRM general counsel, wrote Burnham concerning Reed's Aug. 2 letter. She said his request to appeal the staff decision was rejected because no right of appeal existed for administrative findings. She said the decision did not involve the merits of the research or Smotrich's credentials.

She wrote,

"To be fair to all the applicants (as well as potential applicants who self-selected out of the applications process because they could not meet the eligibility requirements of the RFA), and to carry out its duties as a state agency with integrity, CIRM must consistently enforce eligibility requirements."

Burnham was offered an opportunity to withdraw the application but refused to do so. The decision not to fund the grant was announced late in the day in the waning minutes of the October meeting of the Oversight Committee, a move controlled by Klein in his role as chairman.

The CIRM news release the next day on the meeting did not identify Burnham as losing the grant, a decision made by Murphy, who overruled a recommendation by then chief communications officer Dale Carlson. (Prior to his appointment at CIRM, Murphy was president of the Salk Institute, another medical research organization in La Jolla.)

Carlson had submitted the draft release to Murphy for approval. Its next to last sentence said that the grant to Burnham had been denied. In an email exchange on the evening of Oct. 3 (the day of the Oversight meeting), Murphy said he did not want to mention the Burnham grant.

Carlson then emailed Murphy that the Burnham case and another grant that was withdrawn demonstrated the rigor of staff review and showed that the agency was a good steward of public funds. He wrote:

"Putting out a release in the morning that fails to note these items in light of the press coverage they'll be receiving, would seem like we're being protective and/or inexplicably secretive. Better to include the news at the bottom of the release. It shows we think the items that appear first are more important, but these are at least worth noting."

Murphy then replied to Carlson,

"From CIRM's point of view, you're right. It makes us look meticulous, as we are. But I hate to build our reputation for quality on the carcass of another institution, which no doubt will be embarrassed by the coverage. John Reed will be under fire from his board and donors for allowing this to happen, and we don't want to pile on. Let Burnham handle it anyway they want, but I don't think we suffer by remaining silent. If it hits the fan, I'll take the rap by saying truthfully that it was a technical decision, the science was great, but rules are rules. We did what we had to, and we look forward to their resubmission.

"Thanks for caring so much, but there's a balance on this one, and I think we serve the community kland CIRM best by minimizing the issue and remaining silent."

(Below is the full text of Murphy's response to questions from the California Stem Cell Report.)

(Editor's note: An earlier version of this said that news release following the Oct. 3 Oversight Committee did not contain any mention of the Burnham grant. The news release said a grant had been denied but did not identify Burnham.)

Text of CIRM Response on Reed Letter

Here are the questions that the California Stem Cell Report submitted to Richard Murphy, interim president of CIRM, concerning the Aug. 2 letter by John Reed, president of the Burnham Institute and a member of the CIRM Oversight Committee, and Murphy's verbatim response.

CSCR: Have Oversight Committee members been told that they cannot intervene for or against applicants either before or after ICOC action on applications?

Murphy: "Yes. Members of the ICOC are required to take the Attorney General's on-line ethics course, which includes information regarding the prohibition against participating in a decision in which a person has a financial interest. In addition, the Attorney General's Office made an ethics presentation to the Board in 2005 and CIRM's outside counsel made an ethics presentation to the Board in April 2007."

CSCR: Have any other directors besides Reed intervened?
Murphy: "No.".

CSCR: Was Reed at any time told, either verbally or in writing or any other way, that his letter was inappropriate or improper or may have violated conflict of interest laws.

Murphy: "After CIRM received the letter, Dr. Reed was informed that he must refrain from participating in any way in CIRM's consideration of the Burnham grant. In addition, CIRM staff did not consider the letter in conducting their administrative review of the Burnham grant."

CSCR: Did the ICOC or any committee of the ICOC discuss Reed's action or letter at any point?

Murphy: "Neither the ICOC nor any of its subcommittees received or discussed Dr. Reed's letter."

CSCR: Did any CIRM staff or member of the Oversight Committee or the chairman suggest to Reed that he should write his Aug. 2 letter concerning the Smotrich grant?

Murphy: "Dr. Reed called the Chairman(Robert Klein) to ask how to deal with what Burnham saw as technical mistakes in CIRM’s interpretation of the application. The Chairman, not knowing enough about the technical details or whether mistakes had been made, suggested that Dr. Reed write a letter to the science team, which was knowledgeable about the issues."

CSCR: Does CIRM or the ICOC contemplate any refresher sessions on ethics or conflict of interest for ICOC members? Have such briefings already occurred in 2007?

Murphy: "Yes, in addition to the Attorney General's on-line course, which members are required to take every two years, the Board has received two oral briefings on conflict of interest issues, including in April 2007. The Board will continue to receive periodic ethics training to ensure that members are familiar with the rules."

CSCR: Burnham was told that the denial of the grant would be announced at the ICOC meeting in August. Why did that not happen?

Murphy: "CIRM did not announce in August because Burnham had appealed the determination, and that issue was not resolved before the ICOC meeting in August."

CSCR: Re your note on the press release on the October ICOC meeting and your concerns about how the Burnham institute might feel concerning the Smotrich matter, do you think this was a case where
you put Burnham's interests ahead of CIRM's. Isn't the integrity of CIRM more important than Burnham's or Reed's reputations?

Murphy: "CIRM's action in rejecting the Burnham grant speaks for itself. CIRM staff conducted themselves with the highest degree of professionalism and integrity and informed the Board of their decision at a public meeting in San Diego. Given the public discussion of this issue, I saw no need to include it in a press release following the meeting. My decision was indeed made to be supportive of Burnham, but it in no way compromised CIRM’s integrity or interests."

CSCR: I can only find a link to ICOC conflict of interest policies on the CIRM web site. Were the policies codified into regulations and officially issued as such?

Murphy: "As required by the Political Reform Act, the ICOC adopted a conflict of interest code that applies to members and CIRM staff. In addition, the ICOC voluntarily adopted a conflict of interest policy for its members that goes beyond the requirements of state law. Unlike the conflict of interest code, the policy was not codified into regulations."

Murphy: Does CIRM or the Oversight Committee contemplate any action in connection with Reed's letter?

Murphy: "It is important to remember that Dr. Reed sent his letter after the ICOC had approved the grant, which received the second highest score from a group of out-of-state scientists on the Grants Working Group. At the time, Dr. Reed mistakenly believed that conflict rules would not prevent him from providing technical information regarding the status of a faculty member to CIRM staff. As soon as CIRM staff received the letter, counsel advised Dr. Reed that he must refrain from contacting the staff and board members regarding a grant to the Burnham and advised staff to disregard Dr. Reed's letter. It therefore had no effect on CIRM's process, and Dr. Reed now fully understands the conflict rules. CIRM does not intend to take any further action regarding this matter."

CSCR: If there is other material that you think would help provide insight into this matter, please send it along as well.

Murphy: "None."

Financial Scrutiny of CIRM Coming Up Next Week

The Citizens Financial Accountability Oversight Committee may be one of the more obscure entities in state government. It has only been around for three years. It has only met once. And it already has had a 66.6 per cent turnover in membership.

The group will meet again next Tuesday in San Francisco to consider the doings of the $3 billion California stem cell agency. And it will have plenty to chew on – everything from intellectual property to a 101-page analysis of CIRM by the Bureau of State Audits.

But few surprises are expected. This is a friendly group, created by Proposition 71 and chaired by state Controller John Chiang(see photo), who once brought one of his children to a meeting of the CIRM Oversight Committee in Los Angeles. However, the committee is charged with reviewing CIRM's financial practices and performance, which gives it plenty of leeway to make constructive criticism. Perhaps even recommending public disclosure of the economic interests of grant reviewers who conduct their activities behind closed doors, or at least seeking an opinion from the state attorney general on disclosure, as suggested by the state auditor.

Or the committee could recommend disclosure of the names of the universities and nonprofit research institutions that are seeking $227 million in taxpayer funds to build stem cell labs – names which CIRM has refused to reveal on the grounds that they might be embarrassed.

The group apparently has two new members, Gurbinder Sadana and Loren Lipson. Sadana is a private physician in Pomona, Ca., and serves on the board of directors of the Pomona Valley Hospital. Lipson was recently appointed, and no information was available concerning him/her on the state controller's web site.

One of the new appointees replaces John Hein, who was a lobbyist for the California Teachers Association. The Foundation for Taxpayer and Consumer Rights challenged his appointment as illegal because he did not meet the legal qualifications. Also off the board is Richard Siegal, who runs his own oil exploration company and has given widely to health care issues. No reasons for their departure were available on the controller's web site.

Chiang is also new to the board. The other members of the committee are Daniel Brunner, a retired attorney from the Sacramento area who co-founded Affordable Health Care Concepts in Sacramento; Jim Lott, executive vice president of the Hospital Association of Southern California, and Myrtle Potter, a former vice president of Genentech who now is involved in commercial and residential real estate development. Potter was named as woman of the year in 2006 by the American Diabetes Association and serves on the board of directors of Amazon.com.

One of items on the agenda is a proposal for a conflict of interest code, which was not available on the controller's web site at the time of this writing.

You can find the agenda and other information on the committee here.

Text of Monash Statement

Here is the text of the statement from Monash University concerning the stem cell research investigation that was linked to Alan Trounson, incoming president of the California stem cell agency. The statement was provided by Jeff Sheehy, a member of the agency's Oversight Committee.

STATEMENT OF THE VICE-CHANCELLOR RELATING
TO AUSTRALIAN STEM CELL CENTRE (ASCC) RESPIRATORY PROJECT P028

1.On 28 February 2007 the Project Agreement for ASCC Respiratory Project P028 lapsed and was not extended. Monash and the ASCC agreed to allow funding for the Project to lapse.
2.The component of the Project with results which were questioned was the “COPD Extension Research Project” funded by the ASCC from March 1, 2006 to February 28, 2007.
3.The central hypothesis of the Project was that smoking induced lung damage can be reversed or improved by the infusion of mesenchymal stem cells.
4.In February 2007 the ASCC reported to the University some concerns about the respiratory project led by Professor Alan Trounson, specifically the following issues:
The potential lack of good research practice during the project,
The potential misrepresentation of results and failure to inform the ASCC of specific data arising from the project.
5.Following its independent enquiries, the University established a Preliminary Investigation Committee in April 2007 in order to investigate the concerns raised by the ASCC in accordance with University policies for dealing with matters of possible research misconduct. These policies are based on and compliant with The Australian Code for the Responsible Conduct of Research issues by the NH&MRC, ARC and Universities Australia.
6.The Preliminary Investigation Committee has recently reported its findings of fact to me in a confidential report. I have accepted those findings and have determined (based on the Committee’s findings) that research misconduct by the senior research fellow responsible for the conduct of the Project in Professor Trounson’s laboratory had occurred and that there were mitigating circumstances.
7.Specifically, the Committee found that the senior research fellow engaged in conduct that was negligent and that seriously deviated from accepted standards within the scientific and scholarly community for conducting and reporting research. This conduct consisted of:
negligent recording of research data and recording of analysis of research data by the senior researcher;
negligently inaccurate preparation of reports and presentations of research results provided to the ASCC;
negligently failing to report results in a timely fashion to the ASCC (including results that might have been regarded as counter-hypothesis).
The Committee made no finding that the negligent conduct was fraudulent or designed to deceive.
The senior research fellow has admitted that his recording of data was negligent but indicated that in many cases the primary data for many of the experiments were recorded in other laboratories since many assays were “outsourced”.
8.The Committee also found that there were mitigating circumstances in that the senior research fellow, who had been delegated responsibility by the Project Leader, was inexperienced in managing a research project of the type and size of the Project and managing the number of researchers and students he had to supervise.
9.Professor Alan Trounson was the Project Leader, supervisor of the senior research fellow and chief investigator, of the Project. No allegations of research misconduct have been made in relation to Professor Trounson
10.The University has or will take the following actions:
(a)counsel the senior research fellow who is no longer employed at Monash University that the standards of record keeping and reporting were inadequate;
(b)appoint a research mentor for the senior research fellow to ensure that deficiencies in performance in these areas are appropriately remedied;
(c)enter into discussions with the ASCC to establish what funds the University ought properly to repay to the ASCC in relation to the Project;
(d)instigate a review of University procedures relating to the conduct and supervision of research and ensure appropriate steps are taken to prevent a recurrence of the events that occurred in relation to the Project.
It should be noted that it was considered that the senior research fellow has accepted that the negligence and carelessness exhibited are unacceptable and has shown remorse for his conduct.
11.No material from the Project has been published, or used to obtain further grant funding, the Research Project has lapsed.
12.On the basis of the above, the matter is now concluded.

Professor Richard Larkins
Vice-Chancellor
Monash University

Australian Stem Cell Inquiry Linked to Trounson Concluded

Monash University has apparently reached a conclusion in its investigation into $1 million stem cell research project headed by Alan Trounson, the incoming president of the California stem cell agency.

Trounson was not under investigation, although a researcher who worked under him was.

Here is what the Sydney Morning Herald said:

"A Monash University investigation into an abandoned million-dollar stem cell research project, headed by world renowned Melbourne scientist Alan Trounson, has found data and reports were handled negligently.

"The investigation committee made no finding that the negligent conduct by an unnamed research fellow working under Professor Trounson was fraudulent or designed to deceive."

The newspaper continued:

"In a statement on Friday, Monash Vice-Chancellor Professor Richard Larkins said there were mitigating circumstances leading to the negligence by the senior research fellow.

"The review found that the senior research team member was inexperienced in managing a project of the type and size undertaken and inexperienced in supervising the number of researchers and students he had in his charge.

"It said his work included negligent recording of research data, negligent inaccurate preparation of reports and presentations of research results to the ASCC, and negligently failing to report results in a timely fashion."

The Herald-Sun reported:

"In a statement issued this afternoon by Vice-Chancellor Richard Larkins, a committee investigating the matter found "that the senior research fellow engaged in conduct that was negligent and seriously deviated from accepted standards within the scientific and scholarly community for conducting and reporting research".

John M. Simpson, stem cell project director for the Foundation for Taxpaper and Consumer Rights, had this comment.

"I've not yet read the investigators' report; only Australian news accounts.

"It appears that while Alan Trounson was not implicated in any wrongdoing, the research abuse happened on his watch, done by someone he had hired.

"The incident demonstrates once again the need for strict oversight and adherence to guidelines when public money finances research. Complete openness and transparency are the guarantor of good practices.

"I expect Dr. Trounson has learned from the Monash University incident and will bring an even greater commitment to those essential values in his new position as president of the California Institute for Regenerative
Medicine."

Looking Behind the WARF Stem Cell Patent Challenge

The California scientist behind the challenge to the WARF stem cell patents says scientists have an obligation to be sure that research "can benefit the society that supports it."

Jeanne Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute, made the remark in a recent piece on "Nature Reports: Stem Cells."

Loring wrote about the history behind the challenge to the patents and her motivation. The piece also carries remarks from WARF.

Here are a couple of excerpts:

"We were surprised when WARF responded (to the challenge) with a press release saying, correctly, that I and the other scientists also have patents. This isn't relevant to the validity of the WARF patents, and seems to be an attempt to undermine our credibility. Our patents, like (Jamie) Thomson's, are assigned to companies or to our universities, and we have little control over how they are enforced. We are not challenging Thomson; we're challenging the patent owner, WARF."

Loring continued:

"I do not get paid for our work on this challenge. I did not set out to become an expert in patent law, and it is still very much outside my comfort zone. I'd rather be spending my time learning more about the molecular interactions that make human ES cells pluripotent. But the spirit of scientific inquiry often requires us to venture beyond our areas of expertise, and I think that scientists have an obligation not only to perform research but to make sure that our research can benefit the society that supports it."

Scientific Criticism and Libel Update

The next proceeding in the Flamm-Cha libel lawsuit will be Nov. 20 in Los Angeles Superior Court. The case involves Bruce Flamm, a Riverside, Ca., physician and stem cell researcher Kwang Yul Cha.

Earlier this month, Cha failed to override an anti-SLAPP motion by Flamm. For more on this, see our item here.

Celebrity Leeza Gibbons Named as CIRM Director

The latest addition to the board of directors of the $3 billion California stem cell agency is former television talk show hostess, Leeza Gibbons.

California Gov. Arnold Schwarzenegger Wednesday announced the appointment of Gibbons(shown in photo). She fills the post formerly held by scientist Leon Thal, who died in a plane crash last February. Gibbons fills a slot designated for a patient advocate for Alzheimers as the result of her nonprofit group, Leeza's Place, which is aimed at caregivers for persons with memory disorders.

Gibbons' celebrity status attracted more news coverage than the usual appointments to the CIRM Oversight Committee, which are almost invisible in the media. She co-hosted "Entertainment Tonight" from 1994 to 2000. This year, she appeared on the "Dancing with Stars" TV show, part of the so-called reality genre. She appeared in at least one movie, "Last Action Hero(1993)," with Schwarzenegger.

Gibbons may be the only member of the Oversight Committee with a personal web page and public blog, which can be found on her web site. However, she is not the only Hollywood figure to serve on the 29-member panel. Sherry Lansing, a former top film executive, has a seat on the board. Jonathan Shestack, a Hollywood producer, also is a member.

Gibbons' efforts with memory disorders grew out of her own family's experience with her mother, according to her web page.

The Leeza's Place site says,

"Developed in response to the challenges Leeza and her family encountered while seeking specific and needed support, Leeza's Place is a potent source of information, strength and purpose. Nestled within your own community, Leeza's Place is a multifaceted reprieve, for both caregivers and the recently diagnosed, that integrates educational programs, connective social activities, emotional support, and intergenerational programming designed to help you navigate through your community's continuum of care."

The site also sells books and information on dementia, such as "Brain Longevity" by Dharma Singh Khalsa and "scrapbooking" software, which is aimed at preserving memories. Also offered are a "memories forever" bracelet and a "comfort and care" candle.

The governor, whose motto is "action, action, action," left Thal's position vacant for nine months despite a provision in state law that requires Oversight Committee vacancies to be filled within 30 days. However, it is not uncommon in state government for such provisions to be ignored.

One vacancy now exists on the Oversight Committee: the slot occupied by Brian Henderson, dean of the USC School of Medicine. Henderson has retired from USC, which makes him ineligible to serve. Filling that vacancy is also the responsibility of the governor. Look for Henderson's replacement in nine months.