Stanford Bioethicist Says More Monitoring Needed on California Stem Cell Research

Stanford bioethicist David Magnus says that the research rules of the California stem cell agency "lack adequate monitoring mechanisms."

His views were reported briefly in a recent piece in the Technology Review by writer Emily Singer in an article entitled "Lack of Human Eggs Could Hamper US Cloning Efforts."

Singer wrote:

"Unlike other types of human research, there are no U.S. federal guidelines governing how these experiments should be carried out. President Bush severely limited federal funding for embryonic stem cell research in 2001, including all research involving the creation of new stem cell lines. This has meant that the National Institutes of Health, the nation's largest source of biomedical funding, has not played its normal regulatory role, and individual states and research institutions have had to pick up the slack. "If there were agreed-upon national standards, it would probably speed up much of this protocol approval process," says Arnold Kriegstein, director of UCSF's stem cell program.

"Both Massachusetts and California, the latter via the California Institute of Regenerative Medicine, have recently enacted rules governing embryonic stem cell research. Both sets of guidelines prohibit paying egg donors, but do allow compensation for direct expenses, such as childcare and transportation. California takes it one step further, allowing women to be paid for time off work. It's unclear if Massachusetts law permits this practice.

"David Magnus, a bioethicist at Stanford University, says these regulatory systems lack adequate monitoring mechanisms, though. 'I think it would be an advantage to think about ways to make sure researchers are doing what they say they are going to do,' says Magnus. 'I would guess that we won't see problem with the first few institutions, which have been very careful. Problems would more likely occur down the road, when [nuclear transfer research] starts to become routine.'"

We asked Magnus for further comment on his statement. He responded:

"I made a general point and said that the CIRM rules are similar to most of our research participant protection system, which focuses on informed consent documents, protocols, etc. and very little on monitoring. We could, for example, do quality control activities that other industries have, such as taping some informed consent sessions to determine if that actual consent process does what it is supposed to do (the studies of this sort that have been done have found some problems that could be eliminated). We could also build in studies of the informed consent process into a lot of the research that gets conducted. At this point the CIRM guidelines are actually completely silent on issues that will arise in clinical trials."

Magnus also has more to say about informed consent procedures in the transcript of the June meeting of the ESC advisory committee for the California Department of Health. The group is formulating rules for ESC research in California that is not funded by CIRM.

Magnus cited informed consent procedures involving gene transfer research. He said,

"If you think of gene transfer research as a comparable, cutting-edge research, that’s a good analog to what we are talking about. There’s a lot of empirical studies about how that’s done, and the IRB’s are clearly not doing a good job. Because if you look at informed consent forms that went through IRBs, they’re full of misleading language.....There are maybe two or three studies published in the past year or two about informed consent forms and how awful they are. And that does not even count how - what actually happened in the actual consent process verbally where there’s not as much data, but what has been collected was terrible."

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Protection of Egg Donors Heading for Governor's Desk

Legislation aimed at protecting women who donate eggs for stem cell research in California – except for research financed by CIRM – cleared a state legislative committee and appears headed for the governor's desk.

The measure – SB1260 by Sen. Deborah Ortiz, D-Sacramento – was approved on a 12-0 vote earlier this week. It now goes to the Assembly Appropriations Committee, where it is likely to be sent on to the Assembly floor.

Ortiz' office issued the following statement:

"'Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans,' Ortiz said. 'We all want biomedical research to move forward, but we must ensure that women who provide eggs for research are fully educated about potential reproductive health risks.'

"SB 1260 ensures that women who are considering donating eggs for stem cell research are fully informed of potential risks and provide written and oral consent before taking fertility or ovarian stimulation drugs and undergoing assisted oocyte production (AOP) procedures. The bill limits, in accordance with the National Academy of Sciences, compensation to only allow reimbursement for direct expenses. It also provides payment for expenses associated with any necessary pre and post-procedure medical care.

"The bill will provide a streamlined set of standards for egg donations and continue state oversight that began in 2003 with SB 322 by Ortiz. Under SB 1260, an advisory committee created by SB 322 will finish making recommendations to the Department of Health Services (DHS) so that DHS may develop stem cell research guidelines for reviewing stem cell research projects."

The Health Services advisory committee has said it "is concerned with the designation of the IRBs (institutional review boards)as regulatory bodies of stem cell research, the breadth of the requirement for provision of medical care for adverse medical consequences of donating oocytes for research purposes, and the broad and ambiguous restrictions on who may be a research oocyte donor," according to the latest legislative analysis of the bill.

China No. 1 on ESC Spending, except for California?

Earlier this spring, some members of the California stem cell agency's task force on intellectual property wondered about the size of funding worldwide for embryonic stem cell research, excluding the United States.

The answer seems to be something in the neighborhood of $600 million annually, but that figure could well be low. The total is derived from a report on the CIRM Strategic Planning Site, which reviewed research activities in a number of countries. The report seems to confirm the conventional wisdom that CIRM, at $300 million-plus a year, would be the world's single largest source of funding for embryonic stem cell research.

The CIRM document is called "Overview on the Current State of the Development of New Human Embryonic Stem Cell Lines." The document is heavily qualified and "is not intended to be comprehensive or exhaustive." For example, some of the funding reported is current only as of 2004. And it is not entirely clear whether some of the numbers include funding for non-embryonic stem cell research.

Squishy as the numbers may be, they do provide a window on the size of programs in various countries. The CIRM staff report did not attempt to come up with a total or a ranking, a task attempted by the California Stem Cell Report. Our results are filled with caveats to numerous to mention.

China appears to have the largest annual program with a total as high as $249 million with the United Kingdom following at about $193 million, although it is not clear that all of the UK funding is available. Likewise, China's spending may be less.

Australia comes in at about $47 million, Singapore at $25 million, Korea at $18 million, Canada at $17 million, Israel at $7 million, Sweden at $2.2 million and India at $1.9 million. You may think some of these numbers seem strange. So do we, for a variety of reasons.

For example, Singapore has created a $600 million fund to invest in cutting-edge life science projects, including stem cells. But it is not clear from the document whether any of that money is included in the $25 million total for stem cell research expenditures.

Singapore is also involved with Australia in an endeavor called ES Cell International Pte Ltd. (ESI). It is not clear how the funding for that group is split between the two countries.

Other examples could be cited. But this is a rough cut. Many other interesting bits of grist can be found in the document.

Correction

In a June 20 item, we incorrectly described the Wisconsin State Journal as the Madison State Journal.

Is WARF Patenting Chickens?

Advice to Wisconsin from a Santa Monica group: Get the dollar signs out of your eyes.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, wrote an op-ed piece in the Wisconsin State Journal concerning the state's stem cell patents. In it he chastizes the Wisconsin Alumni Research Association.

He wrote:

"Patenting embryonic stem cells because you have a method to isolate them is like patenting chickens because you have a new method to provide chickenfeed. Or, like patenting food because you can cook. Nonetheless, WARF claims and has, at least for now, been granted the rights to all human embryonic stem cells in the United States. The patents' dubious validity is underscored by the fact that no other country in the world recognizes these claims."

Correction on CIRM Firing Policy

David Serrano-Sewell, CIRM Oversight Committee member, corrected us on the "Two-Boss Brew" item June 20.

Here is what Serrano-Sewell said,

"The ICOC approved (13-5 vote) the 'internal goverance policy.' As you note, the amended policy granted to the Chair the authority to concur with the hiring of certain CIRM staff, Senior Officers. The proposed policy was amended to limit the Chair's concurrence authority to two Senior Officers in legal and communications. Please note, the adopted policy does not grant to the Chair the authority to fire or concur in the firing of those Senior Officers.

"Arguably, the policy is confusing. The President could hire a Senior Officer with the Chair's concurrence and then fire that same Senior Officer without the (Chair's) concurrence."

We thank Serrano-Sewell for the heads up. We appreciate all such messages and try to correct mistakes promptly.

"Good" Audit, Poor Cooperation at CIRM

Should an auditor hired by a state agency refuse to provide copies of information about that agency to the one of the key fiscal watchdogs for the state of California?

One would think not. After all, aren't all state agencies supposed to be working together?

That situation involved the California stem cell agency and the auditing firm, Gilbert Associates, that it hired to conduct an audit as required by law. The state Controller's office is the agency that attempted to secure copies of the information. But Gilbert refused to provide the copies, arguing that the information was proprietary. Based on statements from CIRM and the controller's office, the situation has been cleared up.

But it does not augur well for CIRM's responsiveness to continuing concerns about its openness and transparency.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., said,

"CIRM would have us believe that the audit demonstrates the institute operates within the common practices of state agencies. Other state agencies don't hire auditors who stiff the controller's office when it's operating on behalf of the people of California."

"The bottom line is simple. CIRM is a state agency; they must act like one. I guess CIRM management needs to engrave that motto on their foreheads."

We should not have to remind readers that audits vary widely. And some auditors feel unwilling to bring bad news to the enterprises that hire them. The headlines were full of news a few years ago about collapsing companies with beautiful audit findings.

Here is a link to the San Francisco Chronicle story by Carl Hall on the audit findings. Here is the CIRM press release, the controller's report and the audit itself, which covers only the 2004-2005 fiscal year.

Black Leaves Oversight Committee

Gov. Schwarzenegger has the opportunity to make another appointment to the Oversight Committee of the California stem cell agency with the departure of Keith Black, director of neurosurgery at the Cedars-Sinai Medical Center in Los Angeles.

Black resigned quietly earlier this year. No announcement was made of his departure.

A spokeswoman for the agency said Black resigned because of "time constraints."

Looking Inside CIRM's Planning

Embedded in the California stem cell agency site are significant documents that provide insight and information dealing with how the agency will give away $3 billion.

For example, one summary from a May 25 meeting discusses funding mechanisms involving business and nonprofits as well as whether new embryonic stem cell lines should be the focus of early funding.

The document is intended to be comprehensive concerning discussion at the meeting but does not imply any commitment by CIRM. However, if you are interested in where the $3 billion will go or want some of it, you should watch the strategic planning process carefully. And make your voice heard as well. The agency is moving rapidly.

Here is a sample of interesting themes emerging from the May planning conference on funding structures:

Partnering with other agencies, much as does the Juvenile Diabetes Research Foundation, to extend the reach and impact of funding.

Emphasizing early phase discovery research with a strong focus on "world-class science."

Shaping the nature of grant applications prior to receiving them as do other funding organizations.

And there was this interesting caveat:

"CIRM must be aware that it will be difficult to put out large numbers of grants without potentially exhausting their review committee. For example, JDRF funds about $120M in research per year to about 500 investigators, has about 15 different types of grants, and used 150 scientific reviewers last year. That is far more reviewers than CIRM has."

At another point, the question of renewed federal support for ESC emerged, although questions were raised about the impact.

"Given the flat state of NIH funding, funding will still be tight even if the bill passes. It is not necessarily innovative to derive new ESC lines so funding may be difficult to come by," the document said.

The item below outlines several other documents as well. In the coming months, we will continue to alert you to planning documents as they are posted on the CIRM Web site.

CIRM's Strategic Plan: A Guide (v1.0) to Planning Documents

Here are links to interesting and fresh documents related to strategic planning by the California stem cell agency. During the months ahead, we will continue this regular alert to significant planning documents as they are posted on the Web.

Cord blood -- "Overview of Current Umbilical Cord Blood Banking, Clinical, and Research Activities" – Document reports a suggestion that a "donor-sibling cord blood banking service" be created for California families and that NIH cord blood funding has declined from $21 million in 2002 to $18.6 million in 2006.

ESC Databanks -- "Overview of Current ESC Databanks" – Covers many efforts worldwide. Topics for CIRM include whether there is "a need for CIRM to provide an information resource on human embryonic stem cell lines" and whether CIRM should "create its own ESC characterization database using a best practices approach."

CIRM mission statement proposals – This 18-page document includes proposals presented to the Oversight Committee as well as ones suggested by committee members. Sample from one committee member: "Set the highest standards for scientific integrity, openness, collaboration and technology transfer."

Previous postings on the California Stem Cell Report related to CIRM planning include: questions being asked, Interviewees and their answers, Hall's discussion questions, planning Web page , report from last fall's scientific conference, formal kickoff/overview , clashing interests.

CIRM Strategic Planning: The Questions Being Asked

Here are the questions that are being asked by CIRM as it interviews scores of persons around the country during its planning process. We are posting it verbatim because it does not seem to be available on the CIRM Web site.

The text follows:

Thank you again for your willingness to participate in our interview process for the CIRM scientific strategic planning initiative. We are asking all interviewees to answer questions 1 through 3, as well as 13, but would greatly appreciate your input on the remaining questions on which you would like to comment.

This template is intended for your use only; there is no need to return it to us.

1.In ten years, what will success for the Institute look like?

2.What specific objectives should the Institute pursue in order to realize that vision of success? What are concrete measures of progress along the way to those objectives?

3.What are the most pressing needs that the Institute must address immediately to achieve its goals?

4.Is there "low hanging fruit", that is, opportunities for quick, visible, low-risk successes?

5.What is the best way to foster stem cell research that achieves treatments and diagnostics? Should we target specific diseases for funding or sponsor more broadly based initiatives within which a variety of diseases can be accommodated? If we decide to fund specific diseases, how do we decide how and when to fund to fund that research?

6.Are there specific funding structures (particularly novel ones) that will best help us achieve our objectives?

7.How do we balance funding for targeted research versus funding for discovery?

8.How far along the basic / translational / clinical research continuum should the CIRM aspire to move?

9.When and how should we involve the private sector?

10.How will we know when and how to advance findings into the clinic?

11.How can we encourage collaboration particularly between basic and clinical scientists to advance the science into the clinic?

12.CIRM is allowed to spend up to 10% of its allocated funding for facilities. How important do you consider this as a focus for spending? How can this money best be used?

13.Is there anything else you would like to add or any questions you would like us to address going forward?

Still Simmering: The Two-Boss Brew at CIRM

(This correction was posted 6/23/06:David Serrano-Sewell, CIRM Oversight Committee member, corrected us on the "Two-Boss Brew" item June 20.

(Here is what Serrano-Sewell said,

"The ICOC approved (13-5 vote) the 'internal goverance policy.' As you note, the amended policy granted to the Chair the authority to concur with the hiring of certain CIRM staff, Senior Officers. The proposed policy was amended to limit the Chair's concurrence authority to two Senior Officers in legal and communications. Please note, the adopted policy does not grant to the Chair the authority to fire or concur in the firing of those Senior Officers.


("Arguably, the policy is confusing. The President could hire a Senior Officer with the Chair's concurrence and then fire that same Senior Officer without the (Chair's) concurrence."

We thank Serrano-Sewell for heads up. We appreciate all such messages and try to correct mistakes promptly.)

For Robert Klein, chair of the California stem cell agency, it was a "watershed issue." For Zach Hall, president of the agency, it was a matter of no comment.

The issue was the "two boss" conundrum at CIRM. One member of the Oversight Committee, Jeff Sheehy, said, "This is the sloppiest thing I ever heard of."

The issue surfaced earlier this year over seeming picayune matters (see "dualing execs"). But it has resurfaced again and does not seem likely to go away.

The latest forum was this month's meeting of the Oversight Committee, which oversees CIRM, hires the president and elects the chair. Both have major overlapping responsibilities by law but the conflict has boiled down nominally to to such things as travel, office assignments and concurrence on hiring senior staff.

It was the latter that raised fresh questions about the future dynamics of CIRM. While the agency will administer $3 billion in funding, it is a small organization, now only about 20 employes. By law, it is limited to 50, which means that two strong executives can rub against each other with great regularity. Hall and Klein are two such men.

During the debate over CIRM's internal governance policy, terms like "crazy" and "Rube Goldberg" policy were bandied about, according to the transcript.

Sheehy was perhaps the most vociferous in confronting the situation. At one point, he said,

"We basically set up the situation where someone is going to have two bosses with equal authority....I work for people, so I kind of have a sense of what this means. and this is insane. I couldn't work in that environment. and I don't know why we would want to set up that structure" which he called "completely, totally untenable."

Sheehy was among those concerned about the implications for CIRM when it comes time to find replacements for Hall or Klein or, for that matter, finding top executives who are comfortable serving two masters – not to mention the 29-members of the Oversight Committee.

Sheehy said,

"The more we muddy these (management) lines, the more dangerous it is. We're making compromises. Even having to have these things negotiated out must make the job of the president extremely difficult. And I, frankly, think we should have taken care of this a long time ago. But if you guys (oversight committee members) want to go point by point over the next God knows how many years with how many presidents and fight over office space, travel allowances, hiring of staff at this level, I think we're not going to be able to do the business that we were put here to do."

Ed Penhoet, vice chair of the Oversight Committee, and others stood behind the bifurcated management. Penhoet said Klein was really an "executive chair." (Penhoet did not mention court testimony last winter by Klein, who operates his own financial firm, that he does not consider himself a state employee because he does not accept a salary.)

Others noted that the language of Prop. 71 compels a certain duality. And still others pointed to organizations, such as academic health institutions, that have executives with overlapping responsibilities.

David Baltimore, an Oversight Committee member and president of CalTech, said,

"You can't analyze this situation as you would any other organization because no one would ever set up an organization that has split authority like this except Bob, I'm afraid, because that's not an efficient or effective way to run an organization, to have two heads of two different elements that have to interact. The notion of having a CEO is that the CEO has complete control of the organization. We're not going to get there because we're not going to amend Prop. 71."

Hall's only comment during the discussion was "I have no comment."

Klein said concurrence on hiring senior staff was "critical" to his position. He later agreed to limit concurrence on the hiring of the top executives for communications and legal matters. He resisted suggestions that concurrence be changed to consultation.

"Otherwise I'm not going to feel like I can perform for this board, whether it's a legal function, the financial function, communications areas. I think it's a watershed issue."

Ultimately the Oversight Committee voted 13-5 to give Klein concurrence on the hiring of the two top legal and communications executives. That also gives him concurrence rights on firing them. The committee also, on a voice vote with Sheehy the only audible no, approved giving Hall office assignment responsibilities. On travel, by the same vote, Klein will only need approval of travel from Hall when it exceeds the budget approved by the Oversight Committee for Klein's office.

Early in 2005, the stem cell agency hired Hall, then 67 and a well-respected scientist and skilled administrator, as its interim president for one year. Ultimately he was hired as permanent president following an international search that cost $205,289. We have long suspected that the search ran into difficulties because the top candidates detected the underlying problems with CIRM's two-boss structure. Hall meanwhile was getting a close look at CIRM and Klein and probably thought the issues could be overcome. And CIRM was engaged in a truly remarkable, once-in-a-lifetime endeavor that was hard for Hall to pass up as he neared retirement. Of course, that scenario may be totally wrong but it seems to be reasonable speculation.

Discussions of the top management issues at CIRM preceded the disclosure this month that Klein was not wearing just one executive hat. He is also head of an advocacy group called Americans for Stem Cell Therapies and Cures. As its head, he sent out national emails excoriating a top California legislator as an "ongoing threat" to CIRM for carrying legislation to tighten oversight of the agency. The language in the letter went beyond the Oversight Committee's official position. CIRM said it had no comment on the Klein letter, saying he did it on his own time.

John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., told the California Stem Cell Report,

"Klein needs to decide whether he wants to be ICOC chairman or chairman of his advocacy group. I don't see how he can do justice to both effectively."

CIRM and WARF are Talking Patents

The following correction on this item ran on June 27: In a June 20 item, we incorrectly described the Wisconsin State Journal as the Madison State Journal.

The stakes are global in the Wisconsin vs. California stem cell patent fight.

So says reporter David Wahlberg of the Madison State Journal , who explored the implications of the dispute in a piece that reported discussions are currently underway between the California stem cell agency and the Wisconsin Alumni Research Foundation, which holds the patents.
The story said:

"Mary Maxon, (Vice Chair Ed) Penhoet's deputy at CIRM, said last week that 'there are currently no intentions of suing WARF.' But, she added, 'We are concerned.'"

Wahlberg also wrote:

"One possibility, said CIRM's Maxon, is that the institute might pursue an omnibus license with WARF that would apply to all of its grantees and commercial partners."

The story was rewritten by The Associated Press and distributed nationally. That version appeared in the San Jose Mercury News.

Dateline Juncalito: News for Blog Geeks Only

This blog is now coming to you from the cockpit of Hopalong, a sailboat anchored in the Sea of Cortez off a tiny Mexican community called Juncalito. Small it may be, but not so small that it is without a motto: "Juncalito, a sleepy little drinking village with fishing problem."

Perhaps 50 to 100 Mexicans and gringos live in the "barriocito." All the homes are off the grid – generating electricity either through solar panels or generators. The locals dread the possibility of electrical lines running to their modest homes. They fear rising land values that would push rents higher. Many of the gringo residences amount to no more than a trailer and large veranda shaded by open, palm-thatched structures known as "palapas." No phone service, cellular or otherwise, is available. The community has no stores or services, but does include a small church.

We are connecting from the boat to the Internet via a free Wi-Fi connection. One of the norteamericanos set up the connection through a satellite TV service. Signal repeaters are mounted on two of the homes. Powered by batteries that depend on solar power, the Wi-Fi station is shut down each day at 4 p.m. and comes up sometime in the morning – usually, but not always. Occasionally it does not come up at all. Signal quality is not always the best and sometimes connections are dropped. But the California Stem Cell Report is not complaining. It saves a nearly 40 mile trip into town.

CIRM News Coverage: Inertia, Limits and Business-as-Usual

The routine occurred yesterday, and California newspapers were on it like a dog on a bone.

California newspapers consumed many inches of valuable news space for two pedestrian legal events while at the same time largely ignoring more far-reaching and significant news concerning the California stem cell agency.

The routine matter involves litigation against the agency, and the coverage illustrates nicely how the media works or doesn't work.

Here are the specifics. The losers in the lawsuit against CIRM filed their expected appeal. The state then filed its expected move to expedite proceedings. Nothing changed. There were no surprises. It would have been real news if neither event occurred.

So why was the predictable legal action covered while California newspapers have largely ignored more important developments at the agency, including its unprecedented $1 million gala fundraising effort and what also appears to the unprecedented case of a top state agency executive using his own nonprofit advocacy group to lobby the legislature? This is not an idle musing on our part. Others are wondering, including some members of the CIRM's Oversight Committee.

The answers range from inertia to business-as-usual to the internal structure of newsrooms.

The first difficulty newspapers face in covering the stem cell agency is where it fits. Newsrooms are generally organized along lines that have changed little for decades. Coverage responsibilities are broken into turf areas. Generally politics and state government are covered by the Capitol bureaus. Business by the business news departments. Science by a reporter working on the city or state/national desk. When a business reporter branches out into a story involving a state agency, woe to him or her unless all the appropriate editors have been consulted in advance. Otherwise turf hackles will rise.

CIRM is a cross-over story. It has powerful elements involving politics, government, business, science, health, not to mention religion and ethics(that is a often city-side story). It does not fit neatly into the traditional news definitions. Resolving the differences and deciding on a consistent approach to coverage requires thought and work from editors who are hard-pressed by their daily deadline chores. So decisions are put off. It is simply easier to muddle along in the same old way, which, we should add, is one of the reasons why newspapers have lost significant readership over the last few decades.

CIRM is novel, which should make it a "good" story. However, novelty can again pose barriers. It is simple to cover an election, relatively speaking. It is has been done hundreds of thousands of times. Most of the questions about the nature of the coverage have been asked and answered, perhaps not as well as some would like, but to the satisfaction of many in the news industry. But then comes a state government story (or is it a state government story?) about bigtime fundraising by a state agency. Is it really a historical first? Is it illegal? Is it wrong? Who says so? (After all, reporters cannot make assertions on their own; they must quote an authority.) Editors want black and white answers. There is a low tolerance for ambiguity in the news business. Meantime, the editor tells the reporter, you are already late on that weekend piece I asked you to do. Let's talk later about this other story, if it is a really a story.

State agencies, such as CIRM, additionally have traditionally been given short shrift by Capitol bureaus, which prefer the public arena of the legislature and the high profile of the governor. It is rare to find a state agency that is covered consistently and thoroughly.

In recent weeks, we can add coverage of the June primary election to the mix. Newspapers, which have been squeezing their staffs hard as profits dwindle, are particularly hard-pressed during major election periods. They require diversion of resources to election matters. Secondary matters are put off, sometimes forgotten.

Coverage of CIRM is not easy. It operates in a public backwater – not in the hallowed halls of the Capitol, where reporters are feed and often pampered informationally. In contrast, important CIRM meetings are scattered around the state, requiring expensive trips by reporters. The issues are gray. The subjects are difficult, complex and unfamiliar for most newsies. (What do you mean, there is a patent thicket?). The stories are boring unless skillfully told.

Newspapers covered Wednesday's CIRM lawsuit developments because they fit easily into the traditional definitions of news. No matter that the filings are of little consequence. They fit what newspapers do and have done and will continue to do.

What does all this mean for coverage of the California stem cell agency? The immediate impact comes from the beginning of the summer vacation period. Editors and reporters who normally handle the CIRM stories may not be around. So expect less attention during the coming dog days. The election will continue to consume news space (more limited overall nowadays for profit reasons) as well as newsroom resources that otherwise might be used to cover CIRM. At the same time, the agency is beginning to be old news. After all it has been around for 18 months, which is sometimes more than a lifetime for a news story. Not to mention that is only one of many subjects most reporters are required to cover. Overall, we can expect stabilized or waning coverage of the agency at least through the fall, short of a major scandal or an example of aggressive, first-rate reporting that would stimulate the competitive juices of other newsies. If a scandal develops, it will generate a feeding frenzy that will will ignore any constructive work that CIRM has done.

All this said, we are not denigrating the efforts of the reporters, or even the editors, who have worked diligently on stem cell coverage. But we all operate in environments that limit and shape what we do. Newspapers are no different.

Here are links to the latest stories about the litigation:
Reporter Jim Downing of The Sacramento Bee, Lee Romney of the Los Angeles Times, Steve Johnson of the San Jose Mercury News, Terri Somers of the San Union-Tribune, Rebecca Vesely of the Oakland Tribune. Here is CIRM's press release.

Background Statement from Americans for Stem Cell Therapies and Cures

Here is the background statement by Americans for Stem Cell Therapies and Cures re the letter by Robert Klein concerning SB401. The statement provides some background on the organization as well. (For more, see the Klein-Ortiz item.

The statement begins here

June 7, 2006

Statement of Americans for Stem Cell Therapies and Cures


The statement issued on June 5th, 2006 by Americans for Stem Cell Therapies and Cures (a 501(c)4 organization dedicated to advancing education, patient advocacy, and political support for stem cell research) represents only the views of the Proposition 71 campaign committee organization (originally entitled Californians for Stem Cell Therapies and Cures). The three Directors who signed the statement were Directors during the campaign and they remain Directors. The name of the organization has been changed to indicate a reorientation of focus to national educational needs on stem cell research, as well as the need for reform of the federal restrictive policies that bar effective National Institutes of Health funding of embryonic stem cell research. The organization also strongly supports the expansion of regenerative medicine (including embryonic stem cell research) in other states, as well as continuing its support for stem cell research in California.

No Other Organization Involved in the Statement

No other organization was involved in formulating the statement, directly or indirectly. It represents the position of the Proposition 71 campaign committee as articulated through the renamed 501(c)4. Specifically, the Directors – including the Chairman of Americans for Stem Cell Therapies and Cures, Robert Klein – hold a number of other positions with patient advocacy and/or educational institutions which did not participate in formulating this statement. For example, Robert Klein is a member of the International Board of the Juvenile Diabetes Research Foundation; but, this statement did not involve and it was not formulated with any of their staff or other Board members. Similarly, this statement did not involve and it was not formulated with any of the staff or other Board members of the ICOC or the CIRM. This statement represents the personal viewpoints of the Board members of Americans for Stem Cell Therapies and Cures as expressed through the statement of this entity. Members of the Board were polled to confirm the content of the statement before it was released.

Prior Statements of the Role and Scope of Americans for Stem Cell Therapies and Cures

The current mission of Americans for Stem Cell Therapies and Cures remains consistent with the role previously described by Robert Klein when asked at a press break in the February 3rd, 2005 ICOC meeting in San Diego about his continuing personal role as Chairman of the Proposition 71 campaign committee, then entitled Californians for Stem Cell Therapies and Cures. Robert Klein stated that he would continue as Chairman with the responsibility to guide the federal education and advocacy efforts, with a goal of raising a million dollars for that effort, while working on retiring the remaining $1.4 million in campaign vendor obligations. He specifically pointed out that this organization was completely different and separate from the Alliance for Stem Cell Research (formerly called the California Research and Cures Coalition), from which he had resigned as Chairman before being elected to the ICOC Chairmanship.

Distribution of the 501(c)4 Statement Against SB401 on June 5th, 2006

The statement distributed on June 5th was restricted to organizations and individuals who had previously communicated with the Proposition 71 campaign committee staff and expressed an interest over the last 2 years (since April 2004) in updated information as it became available. The statement to organizations focused on the negative impact potential of SB401 and related unconstructive legislation cosponsored by Senator Ortiz and the anti-stem cell conservative Senator Runner. The statement expressed an appreciation for the highly constructive leadership of Senator Don Perata, Senator Joe Dunn, Senator Jackie Speier, and Senator Deborah Bowen who led a joint legislative effort, with the leadership of the Board and staff of the CIRM, to improve the transparency, public reporting, public notice, and conflicts of interest provisions of Proposition 71. The CIRM now leads the nation, with the most stringent standards in these areas, along with its national leadership on medical and ethical standards for stem cell research. The CIRM developed its model medical and ethical research standards in cooperation with a national task force of the National Academies of Science, supplemented by information and input gained in numerous public hearings in the State of California.

There was no general distribution of this statement, as it was not deemed to be necessary at this time. No interviews were given to promote the statement. The intent of the statement was to rebut the highly misleading statements of Senator Ortiz on the value of SB401 and related legislation which she claimed were essential to address defects in Proposition 71. In her May 12, 2006 Superior Court decision, Judge Bonnie Sabraw rejected the claim by the plaintiffs contesting the Constitutionality of Proposition 71 that there were defects in the Proposition and/or its implementation. In part, she stated:

“The evidence at trial establishes that the application of the Act has been in compliance with hits statutory framework, and that CIRM and the ICOC are operating in the same fashion as other state agencies. Each ICOC member, and each alternate, has taken the oath of office and publicly filed Form 700, the standard form California public officials file to disclose financial holdings. The ICOC developed and adopted incompatible activities statements, the conflict of interest code required by the Political Reform Act, and conflict of interest policies for ICOC members, CIRM staff, and members of each of the ICOC advisory grouops. Between January 2005 and the date of trial, the ICOC, its subcommittees, and its working groups held over 40 noticed, public meetings, in cities across the state, held pursuant to the Bagley-Keene Open Meeting Act. CIRM has responded to numerous Public Records Act requests. The selection of the site for CIRM’s facilities was run by the Department of General Services, as required of state agencies, which department also executed the lease. The required independent audit is in process and is to be reviewed by the Citizen’s Financial Oversight Committee. In addition, testimony was presented that CIRM is subject to audit by the Controller and the Department of Finance, and that the Controller has met with the ICOC to discuss the type of practices he expected the ICOC to follow.”

In 41 additional pages, Judge Sabraw examined Proposition 71 and the CIRM with a microscope and she concluded that it is operating properly, in every facet of its mandate, and it includes numerous safeguards, public transparency, and accountability requirements that are often layered, to provide several levels of protection for the public.

The statement was stimulated by a San Diego Union Tribune article on June 2nd, 2006. It clearly indicated that Senator Ortiz’s press operation had succeeded in misleading a highly responsible and thoughtful journalist as to the Senator’s importance in the “creation” of Proposition 71 and the allegedly positive effect of her legislative attacks on Proposition 71. Senator Ortiz did not see drafts of Proposition 71 until after it was finished and submitted to the Attorney General for certification for the petition process. She did not participate in its drafting. She previously supported Proposition 71, during the election campaign; but, since the election, she has co-sponsored her legislation with the most conservative, anti-stem cell element in the Senate in a “grandstanding” attempt to impose her personal view of how the Proposition should be changed, even after Senator Perata, Senator Dunn, Senator Speier, Senator Bowen, and other legislative leaders had endorsed the enhancements to Proposition 71, jointly constructed with the leadership of the ICOC and the CIRM. Unfortunately, it was not possible for the Board of the Americans for Stem Cell Therapies and Cures and the staff of that organization to draft a response and distribute it to the Board members for clearance until the following Monday, June 5th. It is the intent of the organization to immediately respond, when grossly misleading information on Proposition 71 is issued by any member of a public or private organization. It is hoped that these occasions will be rare.

In addition, as stated earlier, the Legislature – led by Senators Perata, Dunn, Speier and Bowen, with input from the Assembly leadership offices – jointly and constructively worked with the ICOC and CIRM leadership to enhance Proposition 71 provisions. Senator Ortiz participated in these discussions; but, she broke from the group consensus and continued her attacks on Proposition 71, when she realized there was not a legislative consensus to adopt every one of her very detailed demands.

Staffing and Office

Americans for Stem Cell Therapies and Cures operations include sharing a single office at the location of Robert Klein’s personal offices. It has recently contracted with two independent consultants to expand its staffing support for the federal and 5-state focus of its efforts outside of California. Donations to the organization are not tax deductible, because it is a 501(c)4 committed to education, political advocacy, and political reform. Donations can be sent to 550 California Avenue, Suite 330, Palo Alto, CA 94306.

Google Ranks California Stem Cell Report No. 4

We discovered something modestly interesting about "California stem cell" information the other day.

Out of 21.3 million hits produced by Google on that search term, the California Stem Cell Report is ranked No. 4. Yes, that is the blog you are now reading.

No. 1 was a Washington Post article from Nov. 14, 2004, on the election results on Prop. 71. No. 2 was another Washington Post article – this one from Oct. 24, 2004, on Prop. 71. No. 3 is the Alliance for Stem Cell Research, an offshoot of the Prop. 71 campaign group in California. CIRM's Web site is ranked No. 10.

What does all this mean? We don't know, but, as we said, we found it modestly interesting.

Klein's Letter Helps Build CIRM Legacy -- Unfortunately

Whatever the fallout may be from last week's scathing letter about Sen. Deborah Ortiz, California stem cell chair Robert Klein has nailed down one result.

He has it made it more difficult to reach a compromise on Ortiz' sweeping measure to tighten oversight of the California stem cell agency. And if, as a lame duck legislator, she had been inclined to slide back on the measure, that inclination now seems unlikely.

Klein's letter last week called her an "ongoing threat" to the California stem cell agency. The missive, which he signed as head of an advocacy group rather than as chair of the agency, carried a personal, vituperative tone. While it made policy arguments against the measure, SB401, the letter also contained a number of errors and distortions.

Ortiz' office has been silent on the letter. But it is certain that it will harden her resolve to pursue her measure vigorously.

Klein's letter and his previous actions, dating back to his refusal to testify before the state Senate Health Committee in spring of 2005, are helping to create an unfortunate legacy for CIRM. And that is a reputation as an intransigent state bureaucracy that is unresponsive to both public and legislative concerns.

The pity is that sort of fallout was unnecessary.

DHS Stem Cell Advisory Committee to Sunset

Earlier we reported that a measure by Sen. Deborah Ortiz aimed at protecting women egg donors would also extend the life of the Department of Health Services advisory committee on health care regulation.

However, that bill, SB1260, has been amended to remove that extension. Ortiz' office reported:

"As it was originally drafted, SB 1260 did extend the life of the DHS advisory committee currently working on guidelines for stem cell. But the bill was amended April 26, 2006 to allow for the advisory committee to sunset January 1, 2007, as is provided in current law. We retained the provisions (by deleting the sunsets) that require the DHS to produce guidelines, exercise continuing oversight, and report to the Legislature, but decided to let the advisory committee phase out after this year because the expectation was that the committee would complete its work by the end of the calendar year anyway and the costs of continuing it would be too high to sustain."

The bill is now before the Assembly Health Committee after breezing through the state Senate.

Correction on Gala Donor Names

The item below contained a bad link to the names of the donors to the gala. Here is the correct link to the names.