Ethics to Eye Disease: Presentations This Morning at California Stem Cell Agency Meeting

Here are links to a couple of presentations on the agenda for today's meeting of the governing of the $3 billion California stem cell agency.

Ethics presentation by James Harrison, general counsel to the agenda: Topics include conflicts of interest and financial disclosure requirements.

Briefing on eye disease, clinical trial projects backed by the agency.

Salk CEO Brody Named to CIRM Board

The latest addition to the board that controls California's $3 billion stem cell agency is an electrical engineer and a physician. He was once ranked as the highest paid university president in the United States (Johns Hopkins, 2007, $1.49 million). And in pinch he could fly you – as a pilot – to the headquarters of Novartis in Basel, Switzerland, where he sits on the board of directors of that $53 billion pharmaceutical enterprise.

William R. Brody (see photo) is the man who is coming aboard at CIRM. Last fall he took over as head of the Salk Institute in La Jolla, Ca. And last week, California Lt. Gov. John Garamendi named him to replace Martha Chandler, the executive vice president at Salk, on the CIRM board. Chandler presumably resigned in favor of her boss.

In a news release on Friday, CIRM quoted Garamendi as saying that Brody is one of the nation's leading thinkers in biomedical engineering and healthcare policy. CIRM said he has authored more than 100 medical journal articles and co-founded three medical device companies.

Brody's pedigree also includes stints on the board of directors of a number of companies. In addition to Novartis, he currently sits on the IBM board, including its executive compensation committee, and the board of the Commonweath Fund, a foundation working toward a “high performance health system.”

Brody has spoken out and written on subjects of wider interest than those in scientific journals. In 2005, he deplored “the hodgepodge of local legislation, control and restriction (that) does not recognize the fundamentally porous nature of modern research science.” And he raised the specter of a human embryonic stem cell scientist being arrested in an unfriendly state during a layover there.

Also in 2005, he made a comment which seems to have application to CIRM, which refuses to disclose the financial interests of scientists who make the de facto decisions on hundred of millions of dollars in grants. Brody wrote,

“...(C)onflict-of-interest situations should always require disclosure. Disclosure is a necessary—but not sufficient—condition for supervising conflicts of interest. Additional checks, balances or prohibitions may be required to reach an appropriate risk profile for the behavior, but full disclosure is always the vital first step.”

He had this to say on another occasion.

“In my mind, conflict of interest begins the day a scientist has an idea. Even receiving NIH grant support drives a certain mode of behavior that could conflict the objectivity of that scientist. And licensing the idea to outside interests adds additional conflicts. A surgeon who develops a new clinical procedure will want to pursue the development of that procedure—which means conflict, hopefully positive—even without the involvement of an outside company. If she invents a surgical device that enables the operation and licenses that technology to an outside company, the conflict becomes more apparent, even though the conflict was no less real before any agreement was signed. But it is probably impossible to erect a firewall between the scientist and the supposed source of conflict. I know of few surgeons who would use a device invented by someone else if that colleague, even for reasons of conflict of interest, did not use that device herself. As a venture capitalist once told me, 'No conflict, no interest.'”

The July issue of the Salk Institute's house organ carried a profile on its new CEO in which he said, “The best institutions have to have a ruthless commitment to excellence."

That effort includes, he said, “assembling the money for hefty research start-up packages for new faculty.” That could mean a vote – depending on his view of conflicts of interest – for the $40 million research recruitment plan being offered up later this week at the CIRM board meeting.

The Salk profile also has other interesting tidbits, but does not mention that Brody holds ratings as an airline transport pilot and flight instructor, which in theory could make it possible for him to wing his own way to Basel.

Brody's career is indeed impressive. However, he seems careful to soft-pedal it. As he told then San Diego Union-Tribune reporter Terri Somers in an article last fall,

“I grew up in Stockton. Someone from Stockton can't put on airs.”

A $100 Million Agenda Next Week for California Stem Cell Directors

The board of the California stem cell agency meets one week from today to give away $30 million for research into basic biology and to authorize a new, $30 million immunology grant round, not to mention the creation of a $40 million effort to lure top scientists to the Golden State.

The 29-member board is also likely to implement the first stage of its ambitious and risky $500 million lending program for the biotech industry and approve delegated underwriters to run the effort.

CIRM directors additionally are scheduled to discuss the latest revision of the strategic plan, which is now available along with a related report on CIRM operations. The draft plan was posted earlier this week in plenty of time to be read and digested by all interested parties. (We will have more later on the update on the strategic plan.)

Several other matters to be considered also now have background material posted on the agenda, a substantial improvement from the days when such information was very late in coming.

The news out of this meeting – if any mainstream news outlets choose to cover it – is likely to be the $30 million given away for basic biology research. That program calls for about 20 grants over a three-year period. Some of the grants are likely to involve Japanese partners, although California funds are to be spent only in this state.

Scientists and others who want to help shape upcoming grant rounds should take special note of the proposed programs for research leadership awards and for stem cell transplantation immunology grants.

The usual procedure is for the board to approve the “concept” for the awards. Then the staff prepares the RFA and posts it. So next week will be the last chance to present to the CIRM board comments on the proposals and any suggestions for changes.

The research leadership award program is aimed at helping to recruit top scientists to California. The proposal says recipients will be researchers “judged to be highly likely to become world leaders in their fields.”

No exact dollar amount was placed on the effort but CIRM presented an example in which eight scientists could possibly see $40 million or so. That would include up to $1 million for lab renovations and equipment, to be matched by the recruiting institution. The six-year program would also provide up to $186,000 per scientist for annual salaries plus benefits and $300,000 a year for lab operations.

Nominations must come from a California university, research institution or medical center.

The program is certain to find strong support from the 12 heads of research institutions, medical school deans, etc., on the CIRM board.

The other proposed grant round provides $30 million for up to 20, three-year grants for research into stem cell transplantation immunology. Japan and the state of Victoria in Australia are funding partners, meaning that teams of researchers from those countries will be competing.

Given the discussion of the two new grant rounds and the strategic plan, persons interested in the future direction of CIRM and future funding initiatives should be on the scene or at least check in on the online audiocast. The audiocast, however, only allows you to hear the proceedings – not take part.

Directions for listening are already available on the agenda. The meeting itself will last two days and take place at the Mission Bay campus of UC San Francisco.

Time Now for CIRM to Let Sunshine In

California Gov. Arnold Schwarzenegger today set a fine example of openness – one that should be emulated by the California stem cell agency.

His action follows by one day another sterling case of transparency – this one involving a member of the board of directors of the California stem cell agency, Philip Pizzo(on right), whose main job is running the Stanford School of Medicine.

Both men acted to maintain and bolster support for important societal institutions at a time when public confidence in our leaders has been sadly eroded.

It took a bit of a scandal -- disclosed by the Los Angeles Times -- to force the governor to make his move. But today, Californians can check out for the first time online the economic interests of the top state executives appointed by Schwarzenegger. They can also view the officials´ monthly travel expense reports. (The information is a public record, but has not been easily accessible previously.)

The governor put the material online after Michael Rothfield of the Times reported that several top members of his administration charged taxpayers thousands in airfare, hotel and meal costs with little oversight. Two members have since left.

In announcing the new online information, the governor said,

“Since taking office I have taken steps to make government more accountable and responsive to the people. By making the economic, gift and travel information of the senior members of my administration easily available online, we are taking unprecedented steps to open up our government to the people – yet another critical step toward more government transparency.”

On Wednesday, Pizzo announced that Stanford will be posting online “the medical- and research-related consulting activities for some 1,200 physicians and faculty affiliated with the medical school.”

Pizzo, dean of the medical school, said,

"Industry collaborations are critical to furthering research efforts and innovative patient care, but at the same time, concerns over these activities are eroding the public trust. I hope that steps to increase transparency will resonate with those we serve, educate and work with — and reinforce that trust."

The Stanford medical school has been in the forefront of moves to increase transparency in medical research. In 2006, Stanford physicians were barred from ”accepting biomedical industry gifts, including drug samples, anywhere on the medical center campus or at off-site clinical facilities where they practice,” the school says.

The California stem cell agency has promised the highest standards of openness and transparency. In some ways, it is quite open. But it is an agency that was constructed with huge built-conflicts. Its board of directors is dominated by folks from the institutions that have been the chief beneficiaries of CIRM´s largess. As of last October, 18 institutions with representatives on the board (past and present) had received $552 million in CIRM grants.

The political reality is that the structure of the agency is not going to change. Given that fact, it behooves CIRM to lay all its cards on the tables. At least that way, the public knows who stands to benefit from the billions CIRM is giving away at a rate of $24,000 an hour.

CIRM should make the statements of economic interests from its directors and top officials available online in easily searchable and downloadable databases along with their travel and other expenses.

The agency should also disclose the economic interests of its scientific grant reviewers. Although they make the de facto decisions on grants, the reviewers´ statements of interest are withheld from the public and the scientists who are the subject of their scrutiny. That is a situation that naturally generates suspicion, especially since their deliberations are conducted behind closed doors.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., wrote about the Stanford action on his organization´s blog. Simpson called for more disclosure from CIRM. In a comment to the California Stem Cell Report, Simpson said,

“Bob Klein (CIRM chairman) talks about transparency. He ought to do something about…. Working group members aren't required to file any public disclosure now and that is outrageous. If the governor can post monthly travel reports, so can the stem cell agency. Doing less means that claims of transparency are nothing more than empty rhetoric.”

CIRM is currently a bit strapped for cash, but the governor´s office has already done the hard work of setting up online templates for the disclosure statements. It would take little more to fill in the information.

Evidence of public´s current disenchantment with our leading institutions can be read and heard every day. CIRM can help to restore confidence by following the governor´s lead. CIRM will also help itself by acting in a way that demonstrates its responsiveness to concerns about its conduct and openness.

Snippets: Stem Cell Lending to Pizzo Profile

Biotech Loan Program – Coming up Feb. 19 is another CIRM hearing on its ambitious plans for a biotech loan program. This session will be in La Jolla with a teleconference link to San Francisco. If you want to take part in developing the criteria for the effort, which is the brainchild of California stem cell chairman Robert Klein, you should plan on attending or at least sending comments to CIRM. The program could total as much as $750 million, according to Klein, and is aimed at financing development of stem cell therapies in cases where conventional financing is not available. The schedule also calls for a presentation on the plan to the Oversight Committee at its March meeting.

Bush v. CIRM -- The California stem cell agency's statement concerning President Bush and his comments this week regarding stem cell research stirred a mini-debate on a bioethics blog run by Los Angeles physician Maurice Bernstein. You can find the exchange here.

Pizzo Profile – The Fordham alumni magazine carried a nice profile of Philip Pizzo written by Carl Hall, who has covered stem cell issues for the San Francisco Chronicle. Pizzo (see photo from Stanford) serves on the CIRM Oversight Committee and is dean of the Stanford School of Medicine. Among other things, the piece says:

"Even some of the most persistent critics of the California stem cell enterprise credit the value of Pizzo’s steady ethical compass during debate over public oversight and financial standards. While other members of the stem cell governing board filed lengthy financial disclosures, including a fair share of monetary ties to biomedical concerns, Pizzo’s declaration was essentially a blank slate: He steers well clear of any entangling investments, a pattern that can be traced back to his days at the National Institutes of Health (NIH), where he was head of the infectious disease section of the National Cancer Institute from 1980 to 1996."

The piece appeared in the summer issue but we ran across it only recently.

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.

CIRM Director Nova Scores with IPO

It was not a bad financial week for Tina Nova, one of the directors of the California stem cell agency.

She is president of Genoptix of Carlsbad, Ca., which went public this week at $17 a share and then shot up at one point to $27.30. The shares closed at $24.97 today, up 27 cents for the day, even as the Dow Jones Industrial Averages plummeted 362 points.

Terri Somers of the San Diego Union-Tribune reported that the firm, which helps oncologists determine the best treatment for certain cancer victims, is the latest in a series of health-care connected firms to do well on their initial public offerings.

She wrote:

"Scott Sweet, managing director of IPOboutique.com, said investors were eager to snap up Genoptix shares after a recent surge in revenue that was atypical of a biomedical firm."

Dow Jones reported,

"Right now, what we have is a shortage of companies that actually have revenues and all that other good stuff," said Steve Brozak, a biotech and medical-devices analyst who is president of WBB Securities."

New CIRM Director No Intellectual Shrinking Violet

Consider the following from Floyd Bloom, the latest appointee to the board of directors of the largest single source in the world of funding for human embryonic stem cell research.

"A growing problem of major proportions has been staring us in the face for many decades. Until solved, this long-neglected problem presents a gigantic obstacle to the application of the discoveries flowing from biomedical research into deliverable standards of medical practice that could benefit all of society, both in the United States and globally. This problem is the imminent collapse of the American health system. Unless steps are taken soon to undertake a comprehensive restoration of our system, the profound advances in biomedical research so rapidly accruing today may never be effectively transformed into meaningful advances in health care for society.

"Today's term for such evolutions of discovery into application has been dubbed 'translational research'. The appealing notion that research advances travel from bench to bedside is laudable, but conceptually flawed."

Bloom made the statement in 2003 when he was was president of the American Association for the Advancement of Science. While some on the Oversight Committee of the California stem cell agency may share his sentiments, few have expressed them so publicly and eloquently. Indeed, Bloom's views seem, in many ways, a departure from the standard operating procedure at CIRM, which is somewhat wary of flying in the face of established scientific and medical culture.

Bloom (see photo) was appointed this month by state Treasurer Bill Lockyer to fill a vacancy on the 29-member CIRM Oversight Committee. Lockyer said that Bloom has "dedicated his life to biological science research and is responsible for numerous breakthroughs in neuroscience understanding."

Bloom retired in 2005 as chairman of the Scripps Research Department of Neuropharmacology in La Jolla, Ca. At the time, he said he planned to devote more time to Neurome, Inc., a La Jolla biotechnology firm involved research into human neurodegenerative diseases. Bloom co-founded the firm in 2000.

At one stage in his youth, according to an article on Molecular Interventions, Bloom was encouraged to go into journalism because of his penchant for telling stories. In 2002, he became editor-in-chief of Science, the AAAS journal. He spoke with Molecular Interventions about his views on running a magazine:

"The best thing is to have controversy in an intellectual manner because people read it. They like to see the Christians fight the lions, right? And so if you can engage in an intellectual discussion, then you attract readers and at the same time people get informed from the debate because they'll learn parts of alternative arguments."

Bloom, who also served both as president and chairman of the AAAS, carried his views beyond the pages of scientific media. A few years ago, he told the New York Times:

"I'd like for us to consider health care to be regarded as something like a public utility. To me, if we agree that universal coverage is something to be desired, is that really much different than the fact that we've all agreed that everyone in the country is entitled to have electricity, water, telephone connections, if they can pay for it. We have all kinds of ways to help people get those basic provisions of life.

"And health benefits could be viewed in exactly that same utilitarian way. It could be a corporate network like water power and electricity, with regulatory agencies that set the rates for profit."

A $100 Million Collaborative Effort

CIRM Oversight Committee members Ed Penhoet and Claire Pomeroy enjoyed a $100 million day earlier this week in Sacramento.

The occasion was the announcement that the Gordon and Betty Moore Foundation was giving the money to UC Davis to establish a nursing school. Penhoet is president of the foundation. Pomeroy is dean of the medical school at UC Davis.

The Moore donation is the largest ever made to UC Davis and one of the largest ever for the University of California system.

Gordon Moore is one of the founders of Intel. His son, Ken, was present for the announcement. A story written by Bill Lindelof and Dorsey Griffith reported the following:

"He (Ken) said a nurse came into his mother's room and told her it was time for a shot. Betty Moore balked, but the nurse insisted.

"'Turns out she got the insulin shot that should have gone to the patient in the neighboring bed,' said Ken Moore. 'They nearly had two deaths out of one medical error. That was the start of her really being interested in nursing care.'"

Sharon Stello of the Davis Enterprise reported:

"UCD spokeswoman Lisa Lapin said initial connections between the foundation and the Davis campus were made between Claire Pomeroy, UCD vice chancellor for human health sciences and dean of the medical school, and Penhoet, both of whom serve on the California Stem Cell Commission(sic). They started talking about mutual visions for nursing education, and the conversation evolved into the grant."

CIRM Director Nova Taking Her Firm Public

Tina Nova, a director of the California stem cell agency, is looking for a big payday when the company she heads, Genoptix, goes public, seeking to raise $86 million.

The Carlsbad, Ca., firm has filed documents with the federal government announcing its plans for an initial public offering. Genoptix, which reported its first quarterly profit this year, provides laboratory and diagnostic services to hematologists and oncologists. It is backed by venture capitalists including
Enterprise Partners, Chicago Growth Partners, William Blair Capital Partners, Alliance Technology Ventures, Tullis-Dickerson, Excelsior Venture Partners and others.

Nova is one of 29 members of the Oversight Committee for CIRM. The IPO filing, which has lots of interesting business details, can be found here.