Text of CIRM Statement

Earlier this year, we asked Dale Carlson, then CIRM's chief communications officer, for a perspective on the performance of the California stem cell agency. Here is the text of what he provided.

"The early history of CIRM is remarkable on a number of points, particularly given constraints on our budget and staff imposed by the delay in issuing bonds.

"The project is innovative from its inception: no one has ever funded scientific research with debt financing. Governments float bonds for public capital projects routinely – for roads, schools, prisons, libraries, water storage and transport, and other physical infrastructure needs – but never before for the development of intellectual capital until California voters approved Proposition 71. Similar bond programs are now proposed in New York, Texas, Massachusetts, and New Jersey, and have been considered by states in Australia. I don’t offer that as an example of something CIRM has ‘done right,’ but to establish as background the fact that everything we’ve done since is new, untried, and uncharted.

"The CIRM Scientific Strategic Plan specifies clear objectives and funding initiatives for 10 years. The fact that we have a 10-year plan is remarkable. I know of no other government agency (or public company for that matter) that’s ever developed such a far-sighted blueprint for its activities. It sets specific goals and benchmarks so the public can measure our progress. It lays out a detailed course of action for the six months and three years following its adoption. It does not dwell on generalities, as is common in strategic plans for public agencies. We were lauded for being realistic in our goals and for the open, public process used to draft that document, including the scientific meeting held in 2005 to assess the state of stem cell research globally.

"Our medical and ethical standards for research go beyond any in place or recommended by other scientific funding organizations. In at least one case, they’ve been adopted wholesale by another state.

"Our intellectual property policy for non-profits and the for-profit policy currently in development go beyond those of other private and public funding agencies. Again, some believe our requirements go too far, some not far enough. And again, this is another instance where we’re largely working without benefit of a successful model in place at the federal or state level.

"We’ve issued four RFAs, reviewed more than 350 applications, and brought recommendations to our governing board. In each instance, the time from RFA concept approval to grant approval has been far shorter than researchers have seen from other agencies. (Have I mentioned that we have limited staff for this work?) To date, 136 grants totaling more than $208 million have been awarded or approved at 23 institutions.

"We commissioned the Institute of Medicine to hold a conference on the risks to women who donate oocytes, the first meeting ever held on this subject.

"The Institute’s global leadership is well-recognized, even before awarding significant research funds. We forged strong relations with foreign countries and international organizations of stem cell researchers. We were the only state invited to join these organizations. The International Stem Cell Forum will hold its annual meeting next year in California, after considering offers to host the session from Israel and China.

"Few have any experience organizing a new government agency from scratch, let alone one devoted to such a novel concept. We’ve struggled at times with the challenges and requirements that presents, and we’ve not always made the right decisions when first faced with a decision or dilemma. Where we’ve erred or fallen short, we’ve quickly changed course in favor of a better approach. The Bureau of State Audits report is a good example of that pattern. If the BSA found a problem in our policies or practices, we made no attempt to defend or justify our conduct. We simply said, “You’re right. We’ll fix it.” And we have, in most instances.

"Some do not believe the Institute operates with sufficient regard for public participation or scrutiny, particularly where the review of grant applications is involved. Without revisiting the extensive discussions we’ve had with our critics on these points, it’s clear the CIRM is more open, solicitous, and responsive to the public than any other agency – private or public – engaged in research funding. The conflict of interest policy we follow for grant reviewers exceeds the requirements in place at NIH and elsewhere."

Proposed Lab Grant Review Procedures Posted

The California stem cell agency has posted more information on its proposed procedures for the facilities group review of applications for $227 million in grants for construction of stem cell research labs.

You can see the 18-page Power Point presentation here. The San Francisco meeting to consider them is Nov. 15.

CIRM Rules for Grants to Businesses

The California stem cell agency is going to take a whack Nov. 16 at how it proposes to run its program for research grants to busineses, ranging from ethics to allowable expenses to sharing of biomedical materials.

Biotech businesses have plenty to chew on in the 47 pages of proposed policies that have been released in a nicely timely fashion. No excuses if they don't weigh in now.

The actual occasion is an "interested parties" meeting at sites in San Francisco and San Diego that will be linked telephonically. Here is an Internet link to the meeting notice, which includes a separate link to the 47 pages.

The Big Oil-Stem Cell Interface

The peripatetic John M. Simpson is a man of many parts.

As stem cell project director for the Foundation of Taxpayer and Consumer Rights of Santa Monica, Ca., he has followed the affairs of the California stem cell agency, a task that has kept him busy for more than two years. But on other occasions, his work for the foundation calls him to different venues.

Recently he was in downtown Los Angeles at an appearance of the chief executive officer of Chevron Oil. Simpson's job? Bestow the Golden Nozzle award on the chairman. Here is a link to a video that tells all.

More Details Due Friday on Lab Grant Meeting

Regarding the $227 million lab grant item below, Richard Murphy, interim president of CIRM, just sent us the following:

"The slides with the specifics for the meeting are in the process of being edited and should be available on the Web Friday."

How to Wrestle with Requests for $227 Million: CIRM Agenda Vague

The California stem cell agency will deal once again next week with its plans for its largest round of grants ever, but exactly what is on the agenda is a virtual mystery.

No matter. If you are looking for some cash to build labs, you better be at the Facilities Working Group session Nov. 15. The details are what counts here, and missing one could mean the loss of tens of millions of dollars.

On the agenda is something listed only as "Consideration of Process and Procedures for Major Facilities Grants Review Meeting." We queried CIRM for more details. None were forthcoming. Perhaps they will be available in time for applicants and other interested parties to make plans to be in San Francisco.

The facilities group will be dealing with the applications for $227 million in lab construction grants next year, following the scientific review and the first cut in January by the Oversight Committee. The scientific review will be behind closed doors but the facilities group session is scheduled to be public.

The Shifting Sands of Stem Cell Support

New Jersey voters on Tuesday sent a message to sanguine supporters of stem cell research in California: Do not assume that the public is always behind you.

Analysis this morning of the election results is a bit preliminary but news reports are characterizing the rejection of the $450 million stem cell research measure as a surprise.

And it is not good news for those in California who find reassurance in the 59 percent voter approval of Proposition 71 in 2004, the measure that created the state's $3 billion stem cell program.

We have pointed out previously that stem cell research is not well understood by the public. Support for it is weak despite often rosy polls that seem to indicate it is a motherhood issue, at least in the eyes of some at CIRM. That is not the case, as shown in a poll by the Pew Forum for Religion and Public Life. According to that survey, support dropped from 57 percent nationally two years ago to 51 percent in August this year. It also showed that 55 percent of the public had heard little or nothing about stem cell research.

The New Jersey vote signals that it is imperative for CIRM to move forward thoughtfully and effectively on its public education/PR plans and promptly fill the vacant position of chief communications officer.

The New Jersey vote showed the vulnerability of stem cell research in the political marketplace. Voters can be fickle. To forestall erosion of support in California, CIRM must move to shore up its weaknesses. Those include its penchant for closed doors and secrecy – all of which breed suspicion and provide a recipe for scandal.

CIRM Offers $300,000 PR Contract

"Anonymous" posted a comment on our "communications void" item below that merits some attention. Here it is, and here is the link to the RFP that the comment mentions. Our thanks to "anonymous."

"FYI - There is an RFP out for PR firms. The below is from Odwyerpr.com

"CALIFORNIA ISSUES $300K RFP FOR STEM CELL PR


"California's state-backed entity set up to distribute funds for stem cell research has issued a six-figure RFP for state, national and global public information and communications work.

"The California Institute for Regenerative Medicine is backed by $3 billion in bonds and distributes funds via an independent citizens' oversight committee, which plans to dole out nearly $300M each year over the next decade.

"The Institute has issued an RFP for a firm to handle its public information needs for the next year with a budget capped at $300K. The work includes a full media relations program, strategic counsel, outreach to patient advocacy and health organizations, and internal communications.

"The CIRM wants a firm steeped in education and advocacy for scientific and medical research, public funding and related topics.

"Proposals are due Nov. 30."

Science, Libel and the Law: A California Case

A California physician, who also serves on the UC Irvine faculty, says a lawsuit against him by a Korean stem cell scientist is an attempt to "stamp out any critical scrutiny" of the researcher's credentials and techniques.

The matter, which will hit a Los Angeles court room on Wednesday, pits Bruce Flamm against Kwang Yul Cha.

Flamm works at Kaiser Permanente in Riverside, Ca. Cha, an internationally known scientist, heads a "a vast conglomerate of medical facilities in Korea and the United States," according to legal filings by Flamm.

Last March the California stem cell agency awarded a $2.6 million grant to a nonprofit, Los Angeles subsidiary of the Cha organization. Directors of the agency approved the application without knowing the identity of the applicant, following a recommendation from another CIRM panel arrived at behind closed doors. Both procedures are standard for the agency. A flap arose when the media reported the applicant had links to Cha and reported the controversy surrounding the scientist. In September, the subsidiary withdrew its grant application.

The Flamm-Cha story began with a 2001 article by Cha and two other persons that was published in the Journal of Reproductive Medicine. Flamm said it reported that "distant intercessory prayer can double the success rate" of IVF. The article generated international attention and comment, including some from Flamm.

In August of this year, Cha filed a libel lawsuit against Flamm, saying that Flamm defamed him in a March 15, 2007, article in the Ob/Gyn News. In October Flamm filed what is known as an anti-SLAPP lawsuit against Cha.

Flamm's suit is based on a California law aimed at preventing stifling of public discussion through the use of lawsuits. SLAPP is an abbreviation for "strategic lawsuit against public participation."

Flamm is contending that his comments concerned matters of "significant public interest," are not prima facie defamatory and are protected by California's anti-SLAPP statute.

Flamm told the California Stem Cell Report via email that "Kwang Cha's attorneys will attempt to over-ride our anti-SLAPP motion" in Los Angeles Superior Court at 8:30 a.m. Pacific Standard Time on Wednesday.

WARF Stem Cell Patents: The Latest Chapter

Two groups challenging WARF's stem cell patents, an effort supported by the incoming president of the California stem cell agency, Alan Trounson, are rejecting the Wisconsin organization's latest attempt to beat back the move.

The Foundation for Taxpayer and Consumer Rights and the Public Patent Foundation said WARF's latest filings do not merit overturning a preliminary ruling against the organization.

You can find the latest legal argument by the two groups here. You can find the press release here.

Fresh Comment

"Anonymous" has posted a comment on the "high priests" item below. It includes a link to more details on American Chemical Society and its activities regarding open access.

High Priests vs. Open Access to Research

The high priests of the newspaper business – otherwise known as editors and publishers -- have learned about the power of the Internet the hard way. Their business is turning remorselessly downward as advertisers shift their dollars to chase readers who have abandoned print.

Now comes the turn of the high priests of scientific journals. And the forces at work are something that the California stem cell agency will have to confront as it deals increasingly with public access to publicly funded research findings and how quickly that access becomes available.

Merrill Goozner, director of the Integrity in Science project for the Center for Science in the Public Interest, wrote recently that both houses of Congress have approved legislation that would provide free public access to all published articles from NIH-funded research. The measure was opposed by publishers who say that their ability to support independent peer review requires exclusive copyrights.

Goozner cites an article in The Scientist that points out that there may be a link to profits, which in turn are linked to salaries, for example, at the American Chemical Society, which generates $500 million a year from its 36 journals. Several top executives at the society earn more than $750,000 a year.

Any researcher working for a private company knows that he who pays the piper calls the tune. The fact is that taxpayers finance this research. At the heart, they own it just as much as a bank owns a mortgaged house or shareholders own a company.

The Internet is like a tidal force. Resisting its imperative may appear to be possible in the short term, but over the long term the high priests will be sweep out to sea. The alternative is come up with a better business plan and to find a way to ride the tide instead fighting it.

Communications Void at California Stem Cell Agency

During the next few months, the California stem cell agency is embarking on two rounds of grants worth $312 million, with a multimillion dollar public outreach program in the wings -- all of that minus its top communications executive.

Dale Carlson resigned from his post as chief communications officer last month, saying that he wanted to return to the private sector. Carlson joined the agency August 2006 after serving as vice president for corporate affairs with the Pacific (stock) Exchange in San Francisco for 18 years.

Replacing Carlson will be a difficult task. He is a consummate professional, one of the best that we have encountered over decades of experience with practitioners of public relations. He had a keen grasp of the needs of CIRM and the needs of the media and how to achieve a balance that was in the best interest of his employer.

The communications job at CIRM is particularly difficult because it is a unique enterprise with complex responsibilities and tasks. By comparison, most government agencies are straightforward, as are businesses. But CIRM combines both government and business, along with science, politics, morality, ethics, religion and much more. Finding someone who will be knowledgeable and comfortable with the scope of CIRM activities will take considerable work.

Already we have seen some predictable slippage in CIRM's PR functions, relatively minor at this point. But with the $85 million faculty awards due in December and the far-reaching $227 million in lab grants, the need for top notch help looms large.

CIRM is looking for an interim communications person as well as a permanent replacement with a salary range of $130,000 to $195,000. It will certainly need someone on board, whether an outside firm or person, come January when the lab grants are scheduled for approval by the Oversight Committee.

Also coming up in 2008 is a public outreach program, which the strategic plan says could run $4.5 million. Both incoming CIRM President Alan Trounson and interim President Richard Murphy have identified the public education effort as a major priority.

Murphy told CIRM directors last month that the agency is considering hiring an outside firm that would work with "an internal public information coordinator." Murphy said the agency will begin a search for a "firm that is strong in medical affairs and journalism and has good relationships with government."

CIRM is coming out of an unsettled period that was at least a partial result of failure to fill the vacant presidential spot in a prompt fashion. CIRM's chief scientific officer, Arlene Chiu, has left and others as well. It is fair to speculate that absent the disruption Carlson might still be at the agency.

Carlson was the third communications person/firm in the last three years at CIRM, not including a whopping $378,000 contract with the Edelman PR firm. That track record reflects poorly on the agency. We suspect it is partially linked to micromanagement problems. It also may have to do with internal access issues. If the new communications chief is to serve CIRM well, he or she must have complete access at the highest levels of the organization. Otherwise, policies become locked in place without full consideration of all their public ramifications.

Public relations is one of those tasks that seem simple on the surface and consequently sometimes generates poorly informed and self-serving dabbling. The Oversight Committee at one point even engaged in writing PR practices into its grant administration regulations in a way that protected the interests of grant recipients over the agency itself.

CIRM needs to resolve such issues if it is to achieve its public outreach and education goals.

Update on Aussie Stem Cell Research Probe

The latest report out of Australia says that the investigation into the stem cell project at Monash University will be over by the end of this month.

Carly Crawford of the Herald Sun reported today that the probe, which is linked to incoming CIRM President Alan Trounson, is in its final stages. Crawford also wrote that Monash says it will return the $1 million in public funds if it is determined that misconduct occurred.

Trounson, who is not the subject of the investigation but oversaw the research, is clearing out his office prior to his move to California in January, the newspaper reported.

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."

Trounson and Sale of Melbourne IVF

The financial affairs of Alan Trounson, the incoming president of the California stem cell agency, surfaced in this week in the Australian media.

Australian Bioethics picked up a report from the Australian Financial Review that said the sale of Melbourne IVF should mean $8.8 million (Australian) for Trounson.

According to Australian Bioethics, private equity firms are interested in buying the business for about $200 million. Melbourne IVF is the largest IVF clinic in Australia.

StemLifeLine: No to Third Party, Spare Embryo Decisions

Ana Krtolica, chief executive officer of StemLifeLine Inc. of San Carlos, Ca., offers the following on our item concerning the story in the San Francisco Chronicle about her firm. Among other things, the story said the company had triggered protests from both supporters and opponents of embryonic stem cell research.

"StemLifeLine is a life sciences company that offers individuals who have undergone in vitro fertilization, a unique option to develop stem cell lines from their surplus stored embryos.

"As former academic stem cell researchers, we learned that IVF patients who donated embryos for research often inquired about the possibility to access the stem cells derived from their embryos. This inspired us to develop the novel StemLifeLine service - the first of its kind in the world - for IVF patients who wish to develop their own stem cell lines.

"At StemLifeLine, we believe that it is up to IVF patients and not any third party to decide what should be done with their spare embryos. These patients invested financially, emotionally and physically into embryo generation and it is their choice, their genetic material and their responsibility to make the best decision for themselves and their families.

"It is also important to note that clients that choose to use our service may still benefit research while developing their own stem cell lines. The two options are not mutually exclusive. As researchers, the founders and staff at StemLifeLine are personally committed to supporting biomedical research and stem cell research, in particular. Therefore, we provide an option for clients to donate an additional portion of their stem cell lines to any non-profit research facility of their choice at no charge. However, this decision is left entirely up to each patient.

"Finally, there has been speculation about our pricing. Stem cell derivation is an expensive process that requires a high level of scientific expertise, state-of-the-art equipment and significant time investment. Nevertheless, we are able to provide this service for a price comparable to cord blood stem cell banking.

"To conclude, without having personal experience with the IVF process, none of us can fully understand how difficult it is to make a decision regarding the allocation of surplus embryos. Our goal at StemLifeLine is to offer an additional option to IVF patients and it is up to these patients and their families to make the best decision based on their individual needs and priorities."

No Interstate Stem Cell Cookbook

The Interstate Alliance on Stem Cell Research has decided not to offer model policies for openness and transparency throughout the nation or any other model regulations for that matter.

According to Warren Wollschlager, chair of the group, it will focus on compiling and sharing information from various states involved in stem cell research programs. He told the Boston Globe that there will be no national "cookbook." Wollschlager also said the group will not engage in direct advocacy efforts.

Wollschlarger reported that about 24 persons attended the group's two-day meeting last week in Boston, including a handful of public attendees. He said,

"As planned, we did discuss governance issues during the meeting, and clarified that the method by which the IASCR will meet its mission of fostering interstate collaboration is by compiling and sharing information about state specific statutes, regulation and policies. This commitment to collecting and sharing state information is reflected by the focus and charge of the various working groups. Working subcommittees are charged with compiling state specific information, checking out the accuracy of the information with the various states, and summarizing the data for the full committee. All final products of the IASCR will be posted on the IASCR website. I wanted to clarify that the IASCR will not be issuing policy recommendations or developing model statutory or regulatory language."

In an email to the California Stem Cell Report, Wollschlager said that all future meetings of the group will be open to the public.

He also said that the group's web site should be online about Dec. 3 and that the next meeting of the group will be in March or April of next year, probably in Washington, D.C.

ACT and Geron Talk About Clinical Trials

CNNMoney.com has a piece today on two California companies that report they are edging closer to clinical trials on treatments using human embryonic stem cells.

Aaron Smith wrote the article about Geron and Advanced Cell Technology. It also mentioned Novocell.

In the case of the first two companies, Smith said tests could begin as early as next year. However, schedules have slipped in the past.

Smith wrote:

"'What we're seeing now in the stem cell field is like a chess match,' said Stephen Brozak, analyst for WBB Securities. 'The early moves will ultimately dictate who succeeds in the stem cell space.'"

Geron's product involves spinal cord injuries and ACT's vision loss. Novocell is looking at diabetes.

Stem Cell Freeze Flap: Ethics, UC San Francisco, Stanford Involved

"Modern day frankenstein story," "undeniably creepy," "trying to improve the quality of life." Some of the comments on a story in the San Francisco Chronicle involving a firm that offers "to create 'personalized' stem cells from the spare embryos of fertility clinic clients."

The article Monday by Bernadette Tansey said the idea is to freeze the stem cells for possible later use – "insurance for the future" – in the event that medical breakthroughs could make use of them.

The company is StemLifeLine Inc. of San Carlos, which is located south of San Francisco. It charges as much as $7,000 to create and freeze the stem cells with storage costs of $350 currently. Additional fees of up to $2,000 could be charged.

Tansey said the firm's proposal has set off a "flash fire of protest" from both supporters and foes of stem cell research.

Forty-seven comments were filed by the public on the story(they can be read at the end of the Chronicle story). The wide range offers some insight into the magnitude of the public education challenges that stem cell research still faces. Particularly since the Chronicle audience presumably consists largely of stem cell supporters.

The story also reported that the firm's business has triggered something of a tussle involving folks from UC San Francisco and Stanford.

The head of StemLifeLine is Ana Krtolica(see photo), a former researcher at UC San Francisco. On the firm's advisory board is Susan Fisher, who heads the UC San Francisco stem cell program. Olga Genbacev, a member of the firm's board, is a scientist in Fisher's lab. Tansey also reported that "the company's staff and boards include present and former research collaborators of Fisher's."

One of the folks from Stanford arrayed against the firm's proposal was David Magnus, director of that university's Center for Biomedical Ethics. He told Tansey,

"These companies are essentially taking advantage of people's ignorance and fears to make a buck,"

Also commenting negatively from Stanford were Rene Reijo Pera, director of Stanford's stem cell program and formerly of UC San Francisco, and Chris Scott, director of the Stanford program on Stem Cells in Society.

In addition to the comments on the Chronicle site, Monya Baker in Nature's stem cell blog, The Niche, said that it is "troubling" that the company has failed to make any of its customers available for interviews and refuses to provide a copy of the contract that customers sign.