Kuehl to Lay Out CIRM Regulation

Details are scheduled to be disclosed on Friday concerning the latest California legislative foray involving the $3 billion California stem cell agency.

The bill will be carried by State Sen. Sheila Kuehl, D-Sacramento, chair of the Health Committee. Here is a legislative synopsis that was circulated on Thursday. It said the measure would:

"modify and strengthen current and proposed regulations that have been adopted by the ICOC by:

"Codifying requirements that grantees share 25 percent of net licensing revenues on inventions they develop, beyond a reasonable threshold that the CIRM may establish;

"Providing that grantees may only enter into exclusive licensing agreements with uentities that have plans the California Institute for Regenerative Medicine (CIRM) determines will provide significant access to resulting therapies, drugs, and diagnostics for uninsured Californians, rather than plans that merely meet 'industry standards.' 'Industry standards' could arguably include patient assistance plans currently utilized by most drug manufacturers, which have been shown to be inadequate in encouraging access to free or reduced price drugs by uninsured patients;

"Providing that grantees may only enter into exclusive licensing agreements with entities that agree to provide resulting therapies, drugs, and diagnostics to publicly funded health care programs in California at the best available prices, such as the federal Medicaid price;

"Ensuring that the state’s return from its grants to commercial entities for research or therapy development projects is commensurate with its level of investment and is not capped, as recently proposed by the ICOC. This is accomplished by requiring grantees to share 2 – 5 percent of revenues over the life of the product, depending on the level of state funds provided and the contribution made by state-funded patented inventions to the development of the product. An economic analysis commissioned during the campaign for Proposition 71 estimated that, based on the experience of universities and research institutions, the state could receive 2 – 4 percent of revenues on successful therapies and products developed with state funds, without any cap. Using these assumptions, the analysis concluded the state could receive $537 million to $1.1 billion in royalty revenues under Proposition 71.

"As you know, the ICOC has struggled since its inception with the development of standards to ensure a fair return to the state. A report commissioned by the ICOC in 2005 and completed in 2006 actually recommended that grantees not be required to share any revenues with the state. As a result of the introduction of legislation in 2006, the ICOC abandoned that recommendation."

Reporter Steve Johnson of the San Jose Mercury News prepared a story that said the measure by Kuehl and Sen.George Runner, R-Lancaster,

"would require firms that make products based on the institute's stem-cell grants to pay the state up to 5 percent of the product's lifetime revenues.
"Under a policy tentatively adopted on Dec. 7 by the institute, formally known as the California Institute for Regenerative Medicine, the most a company would pay the state would be 1 percent of its product's revenue, plus 9 times the amount of the grant.

"Another provision of the bill is intended to insure that poor Californians can afford treatments developed from the institute's stem-cell grants. It would require that uninsured Californians have 'significant access' to the treatments and that any treatments purchased with public money be provided at federal Medicaid prices, which are typically discounted.

"By contrast, the institute's current policy requires companies to provide their treatments to the state 'consistent with industry standards,' which Kuehl argued could allow companies to charge excessively for the treatments.

"Under Proposition 71, bills affecting the institute's operations can only be passed with a 70 percent majority, which could make it tough to get the measure enacted. Nonetheless, Kuehl said voters were promised the program would generate significant financial returns to the state when they passed Proposition 71 in 2004. The measure authorizes the institute to spend about $300 million a year for 10 years on stem-cell studies. Moreover, she noted that the institute last week awarded its first stem-cell research grants.

"'This is extremely important,' said Kuehl, who chairs the Senate Health Committee. 'We have to nail this down now, because the first grants have gone out the door.'

"'The voters believed they were going to get some royalty or benefit from their dollars,' added Runner's spokeswoman, Becky Warren. 'We just want to make sure that occurs.'

"Dale Carlson, spokesman for the stem-cell institute, declined to comment in detail about the bill until he has a chance to read its language. He also said the agency's policy governing the amount the state receives from companies that receive stem-cell grants is still being revised.

"But Carlson emphasized the institute wants to ensure Californians have reasonable access to therapies developed through its grants and added, 'we look forward to having a continuing conversation with the legislature about these and other issues.'"

Kuehl has scheduled a news conference on Friday to discuss her measure.

Governor's Cyberspace Splash on ESC Research

California Gov. Arnold Schwarzenegger put the state's stem cell issues at the top of his Web publicity agenda for several days earlier this week.

The governor's Internet site carried, on its main media page, video, audio and text on the $45 million in research grant awards by CIRM. A complete video of the news conference in Burlingame on Friday along with the governor's weekly radio address (Spanish and English) was and is still available. The site carried four still photos of the news conference. Claire Pomeroy, a member of the CIRM Oversight Committee and dean of the UC Davis medical school, is also featured in a video blog.

A few notes on matters not necessarily highlighted in the news coverage. It was abundantly clear that governor is committed to making another large loan to the agency if it remains bogged down in legal battles. A reporter questioned whether he was prepared to make another $150 million loan if needed. The governor's response was that he was committed "all the way."

Schwarzenegger also noted "the state teaches the federal government what to do." He said, "We don't wait." The California example, he noted, is rubbing off on other states. ESC research is a "people's issue." As for his role in the matter, he said, "I am a public servant."

Stem cell Chairman Robert Klein was ebullient during the news conference. But he also noted there will be "problems and failures" in the research. "We will learn from them," he said.

Also featured on the video was patient advocate Don Reed, who made heartfelt comments, along with his son, Roman Reed, who is paralyzed. The younger spoke as well, but was not near a microphone for the first segment of his comments.

Eggs: The 'Bigger Deal'

The “cheeky new women's blog” on Salon.com has weighed in the egg business in an item posted by writer Lynn Harris. Here is part of what she has to say on the “broadsheet.”

"Should we, indeed, be a little more freaked out by the egg market? To be sure, it is a much bigger deal than the sperm trade: more money, more commitment, more risk. Which leads to the valid concern about the degree to which brokers prey, say, on leggy blond volleyball players with excellent SAT scores and massive student loans. And which, in turn, makes me think it's important to accept, without judgment, that this is a business. As Harvard economist Debora L. Spar, author of 'Baby Business,' wrote: 'We need to acknowledge the market that reproductive technologies have created and then figure out how to channel this market toward our own best interests ... It's no use being coy about the baby market or cloaking it in fairy-tale prose. We are making babies now, for better or worse, in a very high-tech way ... We can moralize about these developments ... or we can plunge into the market that desire has created, imagining how we can shape our children and secure our children without destroying ourselves.'"

Three Big Ifs

The $45 million California round of ESC research grants has triggered additional interest in stem cell stocks on the Internet.

Writing on stockerblog, an anonymous retired professional in the financial industry issued a rundown entitled “Stem Cell Stocks: The Growth Industry of the Future?”

An excerpt that noted three major caveats:

"There are only a limited number of stocks which are pure plays or semi-pure plays in the stem cell industry. However, if governmental funding increases, if private research continues, and if there are any major breakthroughs, then this could be a very huge industry."

Stockblogger wrote a paragraph each on stem cell companies that are pure or semi-pure plays. The blog is carried also on the "Seeking Alpha" financial website.

Bringing Pizzas to An Appeal?

The Daily Kos, a political blog with huge national readership, carried an interesting piece by patient advocate Don Reed on last week's oral arguments in the California stem cell lawsuit.

Reed was present during the hearing, and, as usual, has a quite personal approach to the affair. Here is a sample of his thoughts as the three appellate judges seated themselves.

“It occurred to me how important the personal element was; I hoped all the judges had slept well, and had a good breakfast or lunch or brunch or whatever. I would have run out and gotten them a pizza if it would have helped. “But there was nothing to be done, no pizza bribes to offer, only to listen, and hope.”

Reed's posting on Kos was a truncated version of his Feb. 15 filing on his own web site, which carried this additional paragraph about a chat he had at the hearing:

“I had a conversation with Ms. (Terri) Somers (a reporter for the San Diego Union-Tribune) on the disastrous shrinkage of newspaper funding—it kills me that newspapers, the foundation of an informed citizenry, are losing ground in every direction—I got to put in my plug for a government bailout of the newspaper industry. If we can bail out the Savings and Loan Industry, why not newspapers, which provide such a vital service to democracy?”

A Prop. 71 for the newspaper business? Probably too risky since even venture capitalists do not seem willing to enter the “dead tree” business -- at least most of them.

Here is a link to Reed's Kos item: http://www.dailykos.com/story/2007/2/15/101926/443
Here is a link to the original column (see his Feb. 15 archives if it does not come up immediately): stemcellbattles.com.

Advisory to Readers

Please bear with us as we continue to work through computer problems
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this web site, has some issues with its software that create
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"New Action Heroes" Win Millions in ESC Research Grants

The word went out this weekend from China to Syracuse: California stands No. 1 in embryonic stem cell research in the United States and, and by at least one account, perhaps in the world.


The occasion, of course, was the approval of $45 million in research grants by the California stem cell agency.

The event generated enormous amounts of favorable publicity worldwide for CIRM and for the cause of ESC research. Gov. Arnold Schwarzenegger  stood before TV cameras and declared that ESC researchers are "the new action heroes."

His theme carried through on San Francisco television station KGO, which aired a more than two-minute-long report by David Louie with loads of sympathetic images of disabled persons and film of confidence-inspiring lab work. Smiles abounded, including some from Roman Reed, who is paralyzed as the result of an injury.

He told KGO viewers:

 

"We are on the road to cures. We are on the road to be able to solve the problems that plague mankind. Millions of people are suffering, and now we're on the road to cure them. This is wonderful."

Reed´s father, Don, stood at Schwarzenegger´s left as he vowed, on camera, continuing support for CIRM.

Reporter Terri Somers of the San Diego Union-Tribune wrote:

"The panel awarded the highest score to a researcher at UCSD (University of California, San Diego), Anirvan Gosh, for his proposed work on coaxing human embryonic stem cells to morph into neurons in the brain, particularly those in the forebrain. It is in that area that Alzheimer's is believed to do damage.

"Gosh's scientific background and the cutting-edge science he proposed impressed the committee, said Zach Hall, president of the stem cell institute."

A number of newspapers wrote that the $45 million in grants exceeded federal spending annually on ESC research. But  Carl Hall of the San Francisco Chronicle reported that the 72 grants covered a two-year period and were about equal to federal ESC spending for the same period. But Hall continued:

"Eighty million dollars in state grants are expected next month, more than enough to make California the world's No. 1 backer of biomedicine's most ethically contentious research."

Mary Engel of the Los Angeles Times reported:

"After more than 12 hours of deliberation Thursday night and Friday morning, the full board made selections from the proposals, which were numbered and had the names of institutions and people removed. The institute staff advised board members, many of whom work for universities or institutions with proposals, on when to recuse themselves because of a possible conflict of interest.

"The process drew some complaints from two government watchdog groups, which pointed out that Connecticut, which has a much smaller stem cell research effort, identified all the institutions and scientists it funded by name, including those rejected. The groups called on the board to publish the names of the California institutions that applied for grants but were denied.

"But even they praised the spirited discussions and lengthy deliberations that went into choosing the grantees.

"`Many of us had expressed concern that the board would act as a rubber stamp and not delve into this in a serious way,´ said John Simpson of Santa Monica-based Foundation for Taxpayer and Consumer Rights. `This is a very good process.´"

The California stem cell agency prepared a press release on awards, quoting stem cell Chairman Robert Klein as saying:

 

"Today marks another milestone in one of the most important public endeavors ever undertaken by California.  Patients and families around the globe will take heart that human embryonic stem cell research is finally beginning to receive the funding it needs and deserves."

As for Syracuse, below is a link to the story there. More than one appeared in China, but here is a link to the Xinhua news agency story.


San Francisco Chronicle: http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2007/02/17/BAGPRO6J7P1.DTL&feed=rss.bayarea

San Diego Union Tribune: http://www.signonsandiego.com/uniontrib/20070217/news_1n17stem.html

Syracuse: http://www.wstm.com/Global/story.asp?S=6102625

 

Los Angeles Times: http://www.latimes.com/news/local/la-me-stem17feb17,1,4500053.story?track=rss&ctrack=1&cset=true

 

Xinhua: http://news.xinhuanet.com/english/2007-02/17/content_5750741.htm


 

Patient Advocate Don Reed on the CIRM Grants

Hi, Folks!

David Jensen was kind enough to allow me a small guest spot in his excellent column.

As you will see, it is not the balanced calm objectivity he always tries for.

I am a supporter of the California Institute for Regenerative Medicine. To me, it is the noblest institution which ever advanced the hopes and dreams of suffering humanity—because its sole function is work for cure, to ease suffering, end pain, and save lives.

Thank you for this opportunity to address you.

Don C. Reed

Oh, and if you would like to see Governor Schwarzenegger, Bob Klein, the Independent Citizens Oversight Committee, Karen Miner, Roman Reed and yours truly in action, go to



http://cbs5.com/video/?id=20865@kpix.dayport.com


---------------------------------------------------------


The California Institute for Regenerative Medicine, the CIRM, is the pride of our nation, the standard for science, and the envy of the world. It did not happen by itself.

Bob Klein dared to dream that California could become the center of the stem cell research universe. He worked tirelessly toward that end, and the Golden State said yes, voting to approve—and fund--the groundbreaking new research.

But lawsuits blocked us, delaying our hopes of cure. Research delayed is research denied. Right now, one hundred million Americans suffer disease and disabilities described as “incurable”, but which might be alleviated or healed with stem cell research. We needed help.

Arnold Schwarzenegger came through. His decision to authorize the $150 million loan was bold, forward-looking, compassionate.

I wish so much that another great champion, Christopher Reeve, could have been with us today. He would have been so proud. The man who, as my son said, was more like Superman in real life than in the movies, gave us a letter saying, “One day, Roman and I will stand up from our wheelchairs, and walk away from them forever.”

I believe in that great dream. And when it happens, when Roman Reed stands up from his wheelchair, we will remember this day.

Thank you, Governor Schwarzenegger. Thank you, Bob Klein. And thank you, California.

Back Online

We are back once again after suffering a terminal computer crash two days ago. We expect to file a report later today and more tomorrow.

CIRM President Hall Speaks to Conflict-of-Interest and SEED Grants

The California stem cell agency will not produce its conflict-of-interest list in advance of Thursday's session to award millions of dollars in public funds to a host of scientists.

CIRM President Zach Hall explains the reasons below in a statement that we received late Wednesday. It is a thoughtful response from a man who is dedicated to the agency's goals and the public good. Nonetheless we disagree with his position. Regular readers are familiar with our stand. Openness in the conduct of the public's business comes first unless compelling and legal reasons exist for confidentiality. When an agency gives away $3 billion in public funds, transparency is paramount.

As an introduction to Hall's statement, we should note that we asked last week for the CIRM conflict-of-interest list, which details which Oversight Committee members will be barred from voting on specific grants because of a legal conflict of interest. The complete list will be provided to the public only after the board makes its decisions, but before each grant is discussed, the names of individual committee members who will be recused will be announced. To understand the full context of this issue, see the previous items on this blog, “Openness,” "Money Machine" and “Shrouded” below. Here is Hall's statement, minus some salutations:

“Just as we were working all-out to prepare for the board meeting, your request arrived. It threw us for a bit of a loop because we had not contemplated such a request; indeed, we had not framed it in the way that you put it. As a result, we have had to think through what we do from a new perspective and to anticipate the ramifications of your request. The first point to make is that we are indeed making such a list – a big task as Dale (Carlson) pointed out – for staff use at the meeting; this work is not yet complete and we do not expect it to be completed until sometime in the morning. Second, we have not given a list like this to anyone outside of CIRM staff before – neither to board members or the public - nor had we contemplated doing so this time.

Two concerns drive our procedures: 1) that we monitor conflict-of-interest carefully and effectively to be sure that board members know when they have a COI and to be sure that they do not participate in the discussion, inadvertently or otherwise; 2) that we focus the discussion and the decision on scientific merit, independent of institution or applicant. At the meeting in September, 2005, when the training grants were approved, each board member received a sheet of paper listing the applications (by number) for which they had a conflict-of-interest. We then made sure that they did not participate in the discussion and their names were not called in a roll call vote. Thus board members did not have information about any recusals but their own.

The process is more daunting this time with 231 applications rather than 26. Each board member will again receive a sheet of paper listing the applications for which they have a COI. Because of the large number of applications and the difficulty of keeping up with the correct application number, we will also announce at the beginning of each discussion, exactly which board members have a conflict of interest. We will do this from a master list that we have made up (are making up), but, as we did before, had not planned to give this list either to board members or to the public. Thus, board members know their own recusals in advance of the discussion, but do not know who is recused from any other application until the discussion on that application begins. We think this is a good procedure.

When you made your request, our initial response was that, although we had not contemplated doing so, there was no reason for us to withhold the information from you when it was ready. On reflection, however, we have realized that if we give a master list to you beforehand, we also have to give to all others, including ICOC members. Passing out the list beforehand will only encourage “decoding” of the lists, as far as can be done, before the discussion to give institutional identifiers to many of the applications before they are reviewed. We believe this is undesirable.

In trying to balance all of these issues, we have decided to follow the procedure outlined above as originally planned, keeping the master list for our own use during the meeting. Those present will hear the announcement, as each application is discussed, of who is recused. After the approvals are completed, we will then make the master list available to you or to anyone else who wishes it.

You would undoubtedly prefer to have it before the meeting, but we believe this is in the best interests of a fair and unbiased proceedings. I apologize for the false start on our part about the procedures that we will follow. This is the first time through for such a large number of grants and we are all scrambling to do the best we can.

The CIRM Lawsuit Appeal: Not a Plus for Opponents

Reporter Paul Elias of The Associated Press used the word “skeptical” three times in his coverage of today's oral arguments in the appeal of the California stem cell lawsuit.

That is how he characterized the appellate court justices during the Valentine's Day hearing concerning attempts to overturn the judgment against opponents of the $3 billion stem cell agency. The hearing also generated rare televison coverage on San Francisco station KGO. The text of the report by Lyanne Melendez was straightforward and appeared favorable to CIRM. But images are what matters on TV, and those were not accessible to us.

The Los Angeles Times also carried a very brief report on its website late Wednesday.

CIRM issued a statement from stem cell Chairman Robert Klein. Among other things, he said,

“Despite the opponents’ efforts, $130 million in Proposition 71 stem cell research funding for scientists is scheduled to be in place by March 15th.”

The opponents, according to press reports, also did not say anything that advanced their arguments beyond those rejected by the trial court judge.

Conflicts, Grants and CIRM Overseers: Openness vs. Fairness

Eighteen months ago, when the California stem cell agency awarded its first grants, members of the Oversight Committee were provided a conflict-of-interest list prior to voting on the grants.

The transcript of the meeting does not make clear exactly what was on that list. Did each member of the committee have a list that showed each grant along with each member of the committee who was barred from voting on that grant? Unknown, based on the transcript.

Last week we asked CIRM for a copy of the conflict-of-interest list for this week's first-ever research grant awards. The information is an important part of understanding the discussion of the grants – who stands to benefit and who stands to lose. It is information that helps give the public and interested parties insight into the process. As we have pointed out, the Oversight Committee has built-in conflicts-of-interest, albeit ones that are legal as the result of voter approval of Prop. 71.

So far the agency has not produced publicly a conflict-of-interest list for Thursday's meeting, but says it will be available before the session. Dale Carlson, spokesman for CIRM, differed sharply with our suggestion in an email to him that CIRM was withholding the list. Here is his response to our continued questions concerning the availability of the list. Carlson's statement provides some insight into the thinking at the agency concerning openness vs. the integrity of the grant review process.

“To the best of our collective recollection, the ICOC members received (in 2005) a list of training grant applications for which they were recused. They did not see which applications their colleagues would be recused from discussing or voting on.

"We are working on a list of potential conflicts each ICOC member might face with each SEED grant application. With 29 members and 231 applications, I'm sure you can appreciate that it is neither a quick nor easy task to evaluate all the statements of economic interest, institutional affiliations, past and current collaborative efforts, etc. Indeed, it is enormously complex. An NIH study section doesn't review 200 applications over the course of a year. We're doing so in but a matter of hours.

"Contrary to your assertion, it is not being withheld. It is simply not finished. We are being extremely diligent. It would be a disservice to the public to provide a document that is incomplete and/or inaccurate. It will be made available when it is finished and in advance of the meeting.

"Given the efforts we have made to ensure each application is judged on its scientific merit, without regard to the affiliations of researchers, there is legitimate concern that disclosing the ICOC members' conflicts may lead some to attempt to ascertain the institutional source of each application. We do not wish to see institutional bias injected into the review process, tarnishing the integrity we have established. Nevertheless, in the interest of transparency, we will assume that risk.

"Finally, no agency in California has ever undertaken so ambitious a program for biomedical research. We are working without a model and without precedent. We have disclosed more information about grant applications and grant reviews than any other California or federal agency, and more than any non-profit grant-making entity.

"We are moving with all deliberate speed to put funds into the hands of scientists, clinicians, and other researchers who can turn stem cells into therapies and cures. We are moving to implement the mandate of seven million California voters. But we will not allow urgency to trump fundamental fairness or the obligation to do what is right. If those objectives require a little additional time, so be it.”

Big Pharma Is Watching

It was stem cells live – surgery and all – in San Diego Tuesday at the Stem Cells Summit.

Terri Somers wrote in the San Diego Union-Tribune about a disectomy broadcast live from Scripps Memorial Hospital as a demonstration of a stem cell therapy that is not years away. The operation involved a Blackstone Medical product called Trinity, a combination of bone and stem cells.

Somers reported that representatives from Big Pharma were at the conference looking for the next big thing. She said:

"Therapies from human embryonic stem cells, which are controversial and receive more media coverage, are much farther from market because the understanding of these cells is nascent, said Tom Baker, a spokesman for San Diego-based Cytori Therapeutics, a stem cell company that sponsored the summit. The summit is an attempt to help people differentiate between the progress in the two fields, and drum up more interest in often-ignored but more advanced adult stem cell research, said Baker, whose company is developing therapies that pull adult stem cells from fat for reconstructive surgery or cardiac problems."

It was stem cells live – surgery and all – in San Diego Tuesday at the Stem Cells Summit.

Terri Somers wrote in the San Diego Union-Tribune about a disectomy broadcast live from Scripps Memorial Hospital as a demonstration of a stem cell therapy that is not years away. The operation involved a Blackstone Medical product called Trinity, a combination of bone and stem cells.

Somers reported that representatives from Big Pharma were at the conference looking for the next big thing. She said:

“Therapies from human embryonic stem cells, which are controversial and receive more media coverage, are much farther from market because the understanding of these cells is nascent, said Tom Baker, a spokesman for San Diego-based Cytori Therapeutics, a stem cell company that sponsored the summit. The summit is an attempt to help people differentiate between the progress in the two fields, and drum up more interest in often-ignored but more advanced adult stem cell research, said Baker, whose company is developing therapies that pull adult stem cells from fat for reconstructive surgery or cardiac problems. “

http://www.signonsandiego.com/news/business/biotech/20070214-9999-1b14stems.html

CIRM's Court Date Draws Coverage

The Valentine Day hearing on the appeal in the California stem cell lawsuit drew two stories today, one in Dow Jones' MarketWatch and the other in the Los Angeles Daily Journal.

Anne Marie Ruff wrote the Daily Journal piece, a fairly lengthy overview of the legal machinations. She quoted yours truly as saying, "California courts are loath to tell voters that they have no business ruling themselves, which is what the initiative process is all about.”

Carolyn Pritchard wrote a shorter piece on Market Watch, covering similar ground. Pritchard linked to a video of an interview with CIRM Chairman Robert Klein. Neither article carried material that would be surprising to readers of this blog.

Sacramento Bee: CIRM Grants 'Needlessly Shrouded'

The Sacramento Bee today endorsed sunshine at the California stem cell agency.

In an editorial headlined "grant process is needlessly shrouded," the newspaper called for legislative changes to open up CIRM. Here is an excerpt:

"Scientists from outside states do much of this review work, and are not required to publicly disclose their potential conflicts of interest. Undoubtedly, some of those scientists have outside consulting work, or personal relationships with researchers seeking funding, that could affect their grant decisions. Yet under the institute's shrouded procedures, it is impossible for anyone -- including researchers applying for grants -- to be assured that grant reviewers are recusing themselves at the proper times.

This lack of public disclosure is the single most glaring problem with the Institute for Regenerative Medicine. While it is momentous that California is now on the leading edge of financing embryonic stem cell research, the institute still hasn't adopted a transparent procedure for policing potential conflicts. Lawmakers, in this session of the Legislature, need to correct that."

The Bee editorial had received two comments from readers as of this morning. Both were generally opposed to ESC research. One asked, "Can we do a recall on ballot initiatives."

We want to assure curious minds that The Bee editorial and our item below, "CIRM Money Machine," only coincidentally appeared within less than 24 hours of each other. No collusion existed. But being a skeptic ourselves, we know that the denial will do no good.

What Do You Think?

Should CIRM continue its policy of secrecy concerning grant applications and the economic interests of those who make de facto decisions on scientists and institutions that should receive tens of millions of dollars of public funds? Let us know by using the comments function below. Just click on the word "comments" and you can leave a note – included an anonymous one that encrypts your identity. See the item below for a discussion of the topic.

The CIRM Money Machine and Potential Scandal

Giving away millions is not always easy.

Eighteen months ago, the talk included references to rubber stamps, "re-reviewing" not to mention honesty and legality.

The scene was Sacramento, Sept. 9, 2005, when the Oversight Committee of the California stem cell agency awarded its first-ever grants, which went for training programs for stem cell scholars at California schools.

The 29-member panel was whipping through the list of soon-to-be recipients when they ran out of applicants with really high scores. It was then that discussion surfaced about whether the board was merely rubber-stamping decisions of its grant reviewers or doing something more.

And it was then that Philip Pizzo, dean of the Stanford School of Medicine, said,

"In a sense our job was to really choose or approve the people who are going to be reviewers, and by way of delegated authority, we're asking them to make recommendations which are really decisions because we don't have all the data."

Pizzo's comment and similar ones by other CIRM overseeers 18 months ago are critical to understanding questions of conflicts-of-interest, openness and transparency at the grant review level. CIRM has imposed a lid of secrecy on virtually all of the doings of the grant review group. Not even the Oversight Committee members, for example, are supposed to know the names of the institutions seeking grants, although it was relatively straight forward to identify a goodly number of the applicants in 2005 based on the bowdlerized information available then. You just needed to be conversant with California institutions involved in stem cell research.

CIRM conceals the names of the applicants lest it embarrass the losers. CIRM says that encourages good science by encouraging potentially rewarding but risky ventures – ones that the authors might not want to vet in public. Moreover, CIRM says the Oversight Committee actually makes the grant decisions – not the grant review committee. Thus such matters as the economic interests of the grant reviewers and their closed-door meetings to give away tens of millions of public dollars are not really important in terms of openness and transparency.

Eighteen months ago, the Oversight Committee only turned down a couple of grant applications that were recommended by the grant review group(the number is not entirely clear from the transcript of the session). The Oversight group is not likely to reject any significant number of recommendations this Friday for SEED grants. If it does, it soon will not have anybody willing to serve on the grant review committee. Moreover, the CIRM directors simply do not have enough information to perform any sort of significant second-guessing of its hard-working reviewers, all of whom are from out-of-state.

CIRM Chairman Robert Klein, in 2005, bridled at Pizzo's remark that reviewers were actually making decisions, which Pizzo conceded was an impolitic choice of words although they clearly reflected the sentiment of a number of committee members. Klein commented again later when Gerald Levey, dean of the UCLA medical school, said, "What is the purpose of discussing everything on an individual basis? Why don't we just vote en bloc? We're just going through this on an individual basis, but it has no meaning."

Klein, who is an attorney, replied,

"We have to go through this on an individual basis because of the laws of the state of California. And to observe the very high standard of conflicts adopted by this board, we have to make sure we have roll call votes on every application. That is the challenge and it is a new process for California as well as a nation."

It IS a challenging and new process, one that does not have to follow the well-trod but not necessarily applicable procedures of older institutions that are fundamentally different than CIRM. The NIH is often cited as a precedent for CIRM's secrecy on grants. But the NIH can easily be controlled by Congress and the President. CIRM is virtually immune from control by the California Legislature and governor.

The California stem cell agency should rethink its policies on financial disclosure and transparency. Opening the doors will help to protect the agency from the suspicions that will certainly surface as the CIRM money machine begins to hand out hundreds of millions of dollars. Not to mention helping to prevent an outright scandal that would be relished by opponents of embryonic stem cell research.

Stem Cell Snippets: Court Appeals, Cheerleading,UC Davis Plans, Pera and Kuehl

Stem Cell Lawsuit Appeal – The time has changed on the oral arguments on Feb. 14 in the appeal of the verdict in the CIRM lawsuit trial. It is now set for 2 p.m.

World's Oldest Cheerleader? – Relentless patient advocate Don Reed says next Friday (when CIRM makes its first research grants) is an "unbreakable date" in San Francisco (actually Burlingame, which is near the airport). In his effort to generate favorable news coverage, he wrote a piece on "StemBlog," which is part of the Stem Cell Action Network. Reed said this about the expected grant announcements, "Worst Scenario: the opposition shows up in full force, which they will– and in support? Old white-haired Don is there by himself, the world’s oldest cheerleader. Best Scenario: a ton of people smiling, including some friends driving wheelchairs, joined in the celebration of a truly historic day, when in the face of seemingly insurmountable odds, a great state led a great nation into a new age."

Losing the Stem Cell Race – The Washington Post and the Sacramento Bee carried an op-ed piece that suggested state efforts to pump up stem cell research are not enough. According to Joseph Fuller and Brock Reeve, the reasons include: "The entry of individual states into the breach left by the federal government has helped drive research activity. But it has also created a patchwork of regulations and funding levels that constrains research collaboration. Expensive and restrictive enabling patents, political controversy and the absence of federal research money, coupled with a long time to market, have made venture capitalists reluctant to invest. In 2005, just over $100 million in venture capital went to stem cell ventures, compared with $500 million in biotech ventures at an equivalent stage."

UC Davis Stem Cell Plans – The campus newspaper at UC Davis has a rundown on $75 million in stem cell research building plans on the campus. Written by Allie Shilin, the piece says: "The newest addition to the center is a 5,160-square-foot Good Manufacturing Practice laboratory to be housed in a 100,000-square-foot renovated portion of the UC Davis Medical Center on Stockton Boulevard in Sacramento."

Reijo Pera – The co-director of the UC San Francisco ESC research center is leaving to join Stanford as director of "human embryonic stem cell research and education for the Stanford Institute for Stem Cell Biology and Regenerative Medicine."

Kuehl's CIRM Legislation – Jesse Reynolds of the Center for Genetics and Society is "encouraged" by State Sen. Sheila Kuehl's proposal to make changes at the California stem cell agency. He writes on Biopolitical Times that her ideas are worthy of support.

Not Enough Info on Egg Donation Risks, Critic Says

The Pro-Choice Alliance for Responsible Research said today that this week's Institute of Medicine report on the risks of egg donations shows "how little scientific data exists about the health risks of egg retrieval."

Susan Berke Fogel, coordinator of the group, made the comment in connection with the document that resulted from last year's conference prompted by the California stem cell agency. She said in a statement:

"By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:
1. Research endeavors that do not require egg extraction procedures solely for research purposes; and
2. Research that will better define the risks of multiple egg extraction, so that meaningful informed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments."

The full text of the statement can be found below. It did not appear elsewhere on Web at the time of this posting.

Text of Fogel Statement

Here is the text of the statement by Susan Berke Fogel, coordinator of the Pro-Choice Alliance for Responsible Research, on the IOM report on the risks of egg donations. Fogel's statement could not be found elsewhere on the Internet at the time of this posting.

"The Institute of Medicine has released a new report of its assessment of the health risks for women who may be asked to provide their eggs for embryonic stem cell research. The report documents how little scientific data exists about the health risks of egg retrieval, and as a reviewer of the report, I believe it misses an important opportunity to lead the way by requiring critically important safety evidence before we ask women to take potentially serious unknown risks with their health.

"There are many paths of investigation in embryonic stem cell research that can move forward while this safety data are being gathered. Scientists can use embryos initially created for in vitro fertilization, but not ultimately used for this purpose and thus available to researchers with the donor’s consent. They can also use stem cells found in amniotic fluid. Even somatic cell nuclear transfer is possible using eggs that do not fertilize during in vitro fertilization.

"Much attention has been given to the known risks of ovarian hyperstimulation that can result from drugs used to stimulate the ovaries to produce multiple eggs. But the risks of drugs used to suppress the ovaries before such controlled hyperstimulation have been much less studied, and the drug most commonly used for this purpose – leuprolide acetate (Lupron) – has never been approved by the FDA for this purpose. We know from the anecdotal reports of hundreds of women harmed by Lupron that such research is essential to establishing an adequate picture of the risks involved. Moreover, the recent drop in breast cancer rates and its link to a decline in hormone replacement therapy (HRT) is a timely reminder of how little is known about the long term effects of large doses of hormones.

"The IOM report accurately states, 'one of the most striking facts about in vitro fertilization is just how little is known with certainty about the long-term health outcomes for the women who undergo the procedure.' It goes on to acknowledge that even 'that limited knowledge is not directly applicable to the safety of ooctye donation for research.' The report then rightfully suggests the need to collect good data, engage in long-term studies, and reduce risks to women.

"Unfortunately, the IOM report elevates SCNT over other avenues of research in the development of future stem cell therapies. By suggesting that researchers must have thousands of women’s eggs now, despite the critical absence of safety data, the report does women a great disservice. A more responsible conclusion would be to call for:

"1. Research endeavors that do not require egg extraction procedures solely for research purposes; and
"2. Research that will better define the risks of multiple egg extraction, so that meaningful informed consent will be possible. This will serve not only women who may want to donate eggs for research, but women who now undergo these procedures as part of infertility treatments.

"Much scientific progress can be made by pursuing avenues of embryonic stem cell research that do not require women to sacrifice their health and well-being while important safety data are being gathered. The decision of whether to proceed with egg procurement for research should be based on adequate scientific evidence. It is premature to ask women to put their health on the line.

"The Pro-Choice Alliance for Responsible Research is a coalition of reproductive health and justice advocates, bio-ethicists, academics, and researchers working to ensure safety, accountability, and transparency in bio-technology from a women's rights perspective."

ESC Research: Doing Well vs. Doing Good

Is embryonic stem cell research an economic boon or boondoggle for California? Or for other states as well?

Writer David Hamilton, formerly of the Wall Street Journal, discussed the subject this week on Slate. Here are excerpts of what he had to say:

"If medical treatments can be derived from stem-cell research, they are at least a decade or two away, if history is any guide. Even then, new therapies envisioned by supporters, such as diabetes treatments that regenerate insulin-producing islet cells, might add to government health-care costs instead of curbing them. The Baker-Deal report (from the 2004 Prop. 71 campaign) figured that stem-cell therapies could save California at least $3.4 billion in health-care costs over the next three decades by assuming the therapies would reduce state spending on six major medical conditions by 1 percent to 2 percent. While the authors cast that as a 'conservative' estimate, they don't even model the possibility that costs might rise instead. Recent medical advances haven't appreciably slowed growth in overall U.S. health-care spending, which continues to rise far faster than inflation.

"Ideally, of course, stem-cell therapies would start a trend in the opposite direction by reducing or eliminating the need for expensive and often lifelong medical care. For that to happen, though, the new treatments would need to largely replace existing ones at a reasonable price, and then doctors would have to use them sparingly—for instance, only on the patients most likely to benefit. None of these assumptions is a particularly good bet under the current U.S. health-care system, in which new treatments are often simply added to older ones, and where insurers so far have tended to pay top dollar for incremental medical advances."

Hamilton continued:

"What about the potential of stem-cell research to spur economic development—can a state that sponsors stem-cell research hope to attract cool scientists who will then draw others, plus a coterie of entrepreneurs and venture capitalists? Biotech companies do tend to cluster in places like San Francisco and Boston, but their overall impact on regional economies tends to be limited. While they often pay high salaries, the vast majority of these companies are tiny, unprofitable startups with fewer than 100 employees. They frequently collapse well before they earn a dollar in sales. Even successful biotech ventures are often bought out by distant drug companies, which sometimes shut down the acquired company while transferring its research activities and any products elsewhere. On top of all that, big states like California and New York are going to wind up competing for some of the very same scientists, VCs, and entrepreneurs, further shrinking the rewards.

"Why did Baker and Deal see dollar signs? The $200,000 stem-cell supporters paid to Deal's firm, the Analysis Group, for campaign consulting might have something to do with it. In an interview, Baker said he didn't think of the report as advocacy but added that 'we knew we were working for people who wanted to pass this thing.' And while he still believes the economic benefits of stem-cell research could be 'quite large,' Baker also describes the report as merely 'one possible version of how things might happen.'"

Hamilton's bottom line:

"None of this means that stem-cell research doesn't deserve government funding. Stem-cell science, after all, remains in its infancy. Nearly a decade after the discovery of embryonic stem cells in humans, scientists still don't know exactly how they work, how to assure their purity, or what unexpected side effects they might have when transplanted into the human body."

Since the Bush administration refuses to support ESC research, Hamilton, concluded "the states are right to ante up where the federal government has failed to. They just shouldn't expect to do well while they're doing good."

Hamilton's piece does not deal with a related reason for the economic argument for ESC research. Creating a dream of riches is an attempt -- generally successful, we might add -- to shift the terms of the debate. It is a no-win proposition if ESC research backers find themselves locked into a discussion of whether they are killing babies.

Media Unexcited by SEED Grant Scores

Tuesday's announcement of the scores on the first-ever research grants to be awarded by the California stem cell agency received virtually no media attention.

A brief note popped in the East Bay Business Times, which is all that surfaced in what one might call mainstream media. But a biotech blog called PIMM published an item and included the scientific ranking of all the proposals. Attila Csordás, posting on PIMM, recommended reading the "WEAKNESSES" (their capitalization) section of the reviews of the grant proposals.

One web site aimed at the big money boys (venture capitalists) also carried a note on the announcement. VentureDeal unfortunately made an error in its item, saying that CIRM was "created by a $300 million general bond" instead of noting that CIRM has authorization for $3 billion in bond funding. (Actually similar errors are not uncommon in reports that we have read over the last two years.) The information on the grant proposals obviously would be useful to investors in the stem cell arena. It gives a quick overview of a number of new areas that some scientists believe are worth exploring including an evaluation of their public value (meaning to California – not as a public company).

Look for the mainline media to hit the actual grant awards next week pretty hard. It is a simple event to cover and will have considerable appeal to television with visuals and interviews with persons who could benefit from stem cell therapy. Freshness of the Congressional debate over stem cell research also will help drive the coverage. Stories will be dominated by numbers and names: How much and which institutions and individuals will be wallowing (sort of) in cash, thanks to a vote of the people more than two years ago.

SEED Grant Recommendations Available

The scored recommendations for funding of SEED stem cell research grants by the California stem cell agency are now available on CIRM's web site.

The posting lists the titles of all the applications, their score, recommendation for funding along with a "public benefit" and "public review report" and a summary of the CIRM working group's review. The public benefit report was prepared by the applicant.

Names of the applicants remain secret.

The Oversight Committee will make the awards next week.

Warm-up for a Big Money Week

You could call it the CIRM Round – the wave of meetings surrounding each session of the California stem cell agency's Oversight Committee.

But in this case it is a mini-wave, given the committee's busy, two-day agenda – freshly posted on the Web -- during which it is expected to award its first research grants. Ahead of that is a meeting of the legislative subcommittee Feb. 12. The presidential search subcommittee met last month.

In addition to consideration next week of the recommendations on $24 million in SEED research grants, the Oversight Committee will take up a report (not yet online) from the search group. Overseers are scheduled to consider recommendations from the legislative panel involving federal stem cell legislation. Legislative matters at the state level involve two umbilical cord blood bills (AB34 and AB40) and possibly proposed legislation by Sen. Sheila Kuehl, D-Santa Monica, chair of the State Senate Health Committee.

That proposal is not specifically listed on the agenda, but should be discussed if the stem cell directors want to move off their reactive legislative posture.

Also on tap are federal rules (OMB Circular A-21) having to with determining costs on grants. It is not clear why this is on the agenda based on the online material, but it is likely to involve issues of separation of federal and state grant money, since federal grants must be isolated from non-approved stem cell lines.

Remote locations for the legislative subcommittee are available to the public in California in Palo Alto, Chico, Sacramento, La Jolla and San Francisco as well as Maui in Hawaii. No remote locations are available for the Oversight Committee meeting Feb. 15-16 in Burlingame.

Twenty-five Secret Applicants for $48.5 Million in Public Funds

On the surface, the odds look pretty good in CIRM's $48.5 million grant program for "shared" stem cell labs.

The institute plans to hand out as many as 15 grants, and only 25 institutions have filed letters of intent. Of course, their names are secret by order of CIRM, even though every major University of California campus is certain to have filed. Include Stanford, USC, the Burnham and Salk Institutes, etc., and it is not hard to come up with something close to 25 non-profit and academic institutions. That number may shrink by the deadline for formal applications.

The reason for the secrecy is concern that losing institutions would be embarrassed. Nonsense, we say. Moreover, this is public money that is being given away, and it should not be done behind closed doors any more than absolutely necessary.

According to CIRM's press release, the institutions must provide a 20 percent match of the total cost for renovation and equipment.

CIRM also said,

"The Shared Research Laboratory Grant Program will fund dedicated laboratory space for the culture of human embryonic stem cells (hESCs), particularly those that fall outside federal guidelines. (Current federal policy prohibits research involving hESCs isolated after August 2001 from being conducted in laboratories constructed with any federal funding.) CIRM’s grants will support the development of core laboratories to be used by multiple investigators and shared by multiple institutions, and provide an environment for scientific research on hESCs under CIRM’s medical and ethical standards."

The grants are expected to be awarded this June.

Do you think the names of the applicants should be secret? You can respond by using the "comments" function below. Anonymous comments are permitted.

Thal Dies in Small Plane Crash

Leon Thal, a member of CIRM's Oversight Committee and a brilliant San Diego neuroscientist, died during the weekend when his small plane crashed in the Southern California mountains.

Thal, a longtime and skilled pilot, was the only person aboard when the plane went down Saturday night, according to a story in the San Diego Union-Tribune by Cheryl Clark and Sandra Dibble.

Thal, 62, was chairman of the neurosciences department at UC San Diego and had served as one of the 29-directors of CIRM since its inception two years ago. The San Diego newspaper wrote that Thal

"was one of the world's leading experts in the development of new therapies for Alzheimer's. He directed the Alzheimer's Disease Cooperative Study, a consortium of more than 70 research centers in the United States and Canada that investigates experimental therapies. He also managed UCSD's Shiley-Marcos Alzheimer's Disease Research Center.

"Thal oversaw more than $100 million in federal research grants and was a collaborator on many others. He and his department had received millions of dollars in research funds over the past 30 years."

In 2004, Thal shared the $100,000 Potamkin Prize, one of the highest honors in neurosciences.

The San Diego paper quoted Henry Powell, a professor of pathology and chairman of the UC San Diego Senate academic senate, as saying of Thal:

"He was a skillful manager of strong-minded people, charming and diplomatic as well as visionary and persuasive."

Thal was appointed to the CIRM board by the governor.

Magnus: Do We Need More Guidelines?

"Too little, too late." That's what Stanford ethicist David Magnus has to say about the recommendations released last week concerning embryonic stem cell research.

The proposals came from the International Society for Stem Research. But Magnus asked, "Do we really need another set of guidelines."

Writing in the San Jose Mercury News, he said:

"The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.

"All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells."

Magnus also said that the "one really novel stand" from the group concerned payment for eggs for research. He continued:

"The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.

"Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance."

The recommendations have been praised by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, who said:

"We are pleased the international guidelines stress public benefit and we will continue to insist that California's regulations provide affordable access to any discoveries or cures resulting from research funded by the state program. Too often stem cell advocates have hyped the immediate benefit of stem cell research. I'm delighted to see the call for realism. The Scientific Strategic Plan for the California Institute For Regenerative Medicine already reflects that realistic approach."

Reporter Terri Somers of the San Diego Union-Tribune quoted Larry Goldstein, an ESC researcher at UC San Diego and a member of ISSCR task force, as saying.

“Realizing that stem cell research is an international community, we have to be able to share cells and our scientific methods across borders with some confidence that we have been doing our work to some agreed-upon ethical standards.”

Stem Cell Counsel Owed $110,000

The outside counsel for the California stem cell agency might be having second thoughts about its political connections.

Remcho, Johansen & Purcell of San Leandro, Ca., is owed $111,000 by the political campaign of former Lt. Gov. Carlos Bustamante, according to a story by Sacramento Bee reporter Shane Goldmacher.

Bustmante's campaign owes $390,000, and the largest component of that is Remcho. Bustamante says he hopes to pay it off, but former politicians who are out of office and don't plan to hold office have a hard time raising cash.

Ironically, the second largest debt, $109,000, is to the Bonner Group, a fund-raising firm, which obviously did not raise enough cash to keep the campaign out of debt.

One also might wonder what a law firm did for a political campaign that costs $111,000. Campaigns do need some legal advice but that is 370 hours at $300 an hour. The Bee said Remcho had no comment on the unpaid bills.

The Pluripotent Presidential Candidate

From PajamasMedia, quoting political consultant Dick Morris:

"Obama is like a stem cell. He can become any part of the body he wants to be."

"He can become the new Democrat that Hillary wanted to be and that Bill Clinton was when he won the nomination."

Comments Update

We are again encouraging all who feel the need or who are inspired to comment on items on this report or on the comments of others. We have improved our "comment" function, enabling a "moderator" provision. We will examine each comment before it actually appears. This will avoid spam type comments and "flaming." The note on the comment pop-up, however, uses the word "approval." Google, which hosts this site, does not allow us to change that word. However, our function is to moderate -- not to endorse or approve of or disapprove of what you have to say. Your comments are yours and yours alone. The "approval" relates to spam and flames. Anonymous encrypted comments are still permitted. And we expect to publish the thoughts of many who disagree with positions of the California Stem Cell Report.

Promoting California's Stem Cell Giveaway

Stem cell advocate Don Reed is beating the publicity drum for the Big Event this month, and it is not the Super Bowl.

Reed, who has a keen sense of PR, is pitching Feb. 16 as an "unbreakable date" in San Francisco. On Jan. 31, he wrote on his blog, stemcellbattles.com:

"There will be lots of reporters… If our friends are not there, who will they talk to?

Hint: the opposition will definitely be there…"

The date is when the CIRM Oversight Committee is expected to conclude its decisions on the first wave of more than $100 million in research grants to be dished out this year.

Reed is well-connected in the patient advocate community. He knows that TV cameras cannot resist sympathetic interviews with persons afflicted diseases or other problems that could be treated with future stem cell therapies. And the TV audience is likely to be much more sympathetic to their concerns than those opposed to ESC research on theological grounds.

Perhaps state Sen. Sheila Kuehl, D-Santa Monica, is also considering being on the scene, which could be an excellent venue to promote her legislation concerning the stem cell agency. TV rarely covers the agency, and it is not likely to become excited about a legislative story unless it becomes truly extraordinary.

Legislators Target California Stem Cell Agency

The California stem cell agency may have believed its difficulties with the California legislature had vanished, but no such luck.

A bipartisan attempt is underway to change the composition of CIRM's Oversight Committee and dictate some terms of its intellectual property policies, among other things. The effort must be bipartisan because a colossal majority of 70 percent of both houses is required to pass a bill affecting CIRM. The governor's signature is required as well.

Reporter Malcom Maclachlan of the Capitol Weekly was the first to break the news about the latest effort to assert legislative influence over CIRM. He said Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley, will author the legislation. Kuehl is the chair of the Senate Health Committee, replacing Deborah Ortiz, who stem cell Chairman Robert Klein once denounced as an "ongoing threat." Ortiz left the legislature because of term limits. Runner is a Republican leader in the Senate, serving as its GOP caucus chair.

Maclachlan wrote that legislation now being drafted would require that two "public interest" representatives be appointed to the 29-member CIRM Oversight Committee. That presumably would mean that two persons now on the board could lose their seats, since the measure does not provide for increasing the size of the committee.

The legislation also "would allow the ICOC to negotiate royalties of 2 percent to 5 percent on any treatments developed via grants to for-profit entities; there would be no cap on the royalties the state could receive."

Maclachan, who has produced a number of stories on the stem cell agency, continued:

"The bill would also force for-profit entities to offer these treatments to the state at the Medicaid prices, rather than the current requirement that they be offered in line with weaker standards under the California Prescription Drug Discount Program. Finally, it would widen the definitions of what state agencies would be eligible for the discounts. Current CIRM regulations limit this to the state discount drug program, while the legislation would open it to any state agency, including prisons and county indigent health-care programs."

Maclachan quoted Dale Carlson, spokesman for CIRM, as saying the agency would have no comment until it had an opportunity to review the bill.

Carlson also said:

"We have benefited greatly from the Legislature's advice and counsel in years past, and we look forward to a continuing cooperative partnership. We are interested in any and all ideas that can bring stem-cell treatments and therapies to fruition."

Winning passage of the legislation would be a remarkable achievement. No other legislation requires 70 percent approval – not even the state budget or tax increases. Negative votes from only 13 senators can kill the bill. But the measure will certainly provide a forum for lawmakers and others to make their voices heard at more length than the three minutes allowed for each public comment at CIRM meetings.

For more on the reasoning behind the legislation see the item below.

Rationale Behind Kuehl's Stem Cell Legislation

The new chair of the California State Senate Health Committee will "push the CIRM to live up to its promises," including insuring that all Californians will have access to any therapies developed as the result of state-funded stem cell research.

So says the January newsletter put out by Sen. Sheila Kuehl, D-Santa Monica. The newsletter carried a piece by Peter Hansel, staff director of the Senate Health Committee, that discussed the California stem cell agency at some length, including needed changes. Hansel, it should be noted, also served as a Health Committee analyst when it was chaired by Sen. Deborah Ortiz, who is now out of office.

Hansel wrote that Kuehl disagrees with arguments that CIRM should should go easy in terms of royalty requirements and affordable access to cures and therapies. He noted that CIRM has adopted some IP rules that respond to legislative concerns. Hansel continued:

"However, regulations governing the pricing of stem cell therapies in California run counter to assurances given to the Legislature. While at first proposing that grantees and licensees sell such therapies to publicly funded programs at the federal Medicaid price, the CIRM has recently reduced that to a requirement to sell at the same prices they offer them to the state’s new California Prescription Drug Discount Program, a significantly less favorable price. Similarly, the regulations for grants and loans to commercial entities propose to cap the amount of revenues coming back to the state associated with most products developed with Prop. 71 funds, as opposed to giving the state an open-ended return commensurate with its investment. By contrast, New Jersey, which also allows commercial entities to receive grants under its stem cell research program, requires such grantees to share a percentage of revenues—one percent—on an open-ended basis from licensing or commercialization of inventions (two other states that fund stem cell research, Illinois and Connecticut, do not allow for-profit entities to receive funding while another two, Maryland and Illinois have yet to develop policies for grants to for-profits). Capping returns from joint research ventures also appears to run counter to the practices of most universities who co-fund research with commercial entities and the venture capital industry.

"In addition, recent changes require grantees to grant exclusive licenses for inventions they develop to entities that agree to have plans at the time of commercialization to provide access to resultant therapies and diagnostics for uninsured patients, consistent with 'industry standards,' The current industry standard, the patient assistance programs that have been developed by the major drug companies, have been shown to be woefully inadequate in encouraging access to free or reduced price drugs for uninsured persons. Thus, it is incumbent on the CIRM to develop a more meaningful standard than this."

calif legislation, IP, affordability, access, skuehl, phansel

Good to See a Lively Debate

We would like to call your attention, once again, to the comments feature on this Web site, particularly the exchange on the "$100 Million Grant" a few items below. That exchange brings in new information and expands the discussion concerning the California stem cell agency, which is one of the goals of this particular Internet enterprise.

Making a comment is straightforward. Just click on the word "comment" at the end of each item and a form will pop up. You can even make your comments anonymously. Google, which is the site housing the California Stem Cell Report, encrypts the name of the sender so that it is not available to yours truly or others.

CIRM Presidential Search: Bids for Search Firm Perhaps Next Week

Bids could go out in a few days for a presidential search firm to assist in finding a new executive for the California stem cell agency.

The current president, Zach Hall, has the authority to move forward and sign contracts up to $250,000. The search firm contract, which is not likely to exceed that amount, would not have to go to the Oversight Committee, as we presumed in the item below.

Responding to our query, Dale Carlson, spokesman for the institute, also said no documents, other than the presidential criteria, were distributed at Wednesday's presidential search meeting concerning the bid process, timetable or "interim action."

CIRM Presidential Search: Concern Over Leaks, Search Bids Likely

The California stem cell agency is moving to ask for bids from firms to help in the search for a new president of the $3 billion agency.

The Presidential Search Subcommittee Wednesday voted 12-1 to seek the bids, we have been told. Presumably that will require ratification by the full Oversight Committee later this month.

Joan Samuelson, a member of the Oversight Committee, was reportedly the only negative vote, saying she wanted to define the job before hiring the search firm.

Some members of the search committee also were not happy about the disclosure that James Battey, the federal stem cell chief, was approached about the job. Their concern was that other good candidates might be driven off.

However, Battey's name was certain to come up as are the names of others who were considered in 2005. At least the names that became public. The California Stem Cell Report has a strong bias towards openness on the part of public agencies, including CIRM. However, this is one case where confidentiality is important. A job search for president that has all its candidates on public display is a poor way to hire good people. That said, it is difficult to control leaks on a high profile job such as CIRM president.

Confidentiality starts with the Oversight Committee. If they discuss names with outsiders, they can expect leaks. Candidates themselves will also lead to leaks if they discuss the job with others, which is likely to be part of their process of evaluating CIRM.

The Oversight Committee can also expect situations like Battey's. His name apparently emerged because of the way the NIH works. That could happen with other candidates as well.

As for the California Stem Cell Report, we will carry the names of candidates if they emerge in news stories and perhaps under other newsworthy circumstances.

CIRM Presidential Search: Battey Approached

One of the directors of the California stem cell agency has approached federal stem cell chief James Battey to see if he is once again interested in seeking the presidency of the state's $3 billion research effort.

Nature magazine reported today that Battey, chair of the NIH stem cell task force, had been approached. He was a candidate for the position in 2005 but dropped out of consideration.

In a piece by Meredith Wadman, Nature reported that Battey "has been excused from all stem cell related work" at the NIH. He remains as director of the National Institute on Deafness.

Nature, which did not say which CIRM director had approached Battey, wrote:

"The search committee hasn't discussed a shortlist 'with any real seriousness,' member Joan Samuelson, founder of the Parkinson's Action Network, told Nature on 29 January. 'We need to think about what talents and what skill set we need in the new president. And we should be clear about that before we write a job description,' she said."

The magazine continued:

"Battey is highly respected within the NIH as an able administrator who rarely makes trouble, but who will speak frankly when necessary. During the controversy over tightened conflict-of-interest rules at the agency, Battey said bluntly that if it adopted the stringent set of rules thatwas first proposed, he would resign (see Nature 435, 397; 2005). The rules were loosened before they were finalized.

"Battey's absence from his NIH stem-cell duties became publicly apparent at a 19 January Senate committee hearing on human embryonic stem-cell research. There, Story Landis, director of the National Institute of Neurological Disorders and Stroke, testified on behalf of the agency. She is now acting chair of the Stem Cell Task Force. It has also emerged that Battey will not be attending a meeting of stem-cell funding agencies being held in Singapore this week."

When Battey withdrew from consideration for the CIRM presidency in May 2005, he told the California Stem Cell Report that the position at CIRM was "exciting and important" but that his current position at NIH was also an "important opportunity."

We queried Battey to see if he has more to say currently on the subject. He did not.

CIRM Guide to the $100 Million Grant Process

The California stem cell agency has posted on its Web site a useful guide to its plans for handing out more than $100 million in research grants, including timelines and other procedures.

Much of the information has been available before but it was scattered and hard to find. Now it has been compiled in a tidy package. Some of the information is fresh. For example, the memo said:

"In the first week of February, we will release a list of all the SEED Grant applications. That list will include the title of the research proposal, the numeric score (1 to 100) it received from the Grants Working Group, and the Working Group’s recommendation (Recommended for funding, Recommended if funds available, or Not recommended for funding at this time). From our Web site, viewers can click on the application number to open a public abstract of the proposal, a statement of its benefits to California, the applicant’s proposed budget, and a summary of the Working Group’s review."

The memo also reiterated the agency's intention to maintain its secrecy concerning the names of those seeking millions of dollars in government funds – a dubious practice adopted because that it is the way it always been done (at least on the federal level) to protect rejected applicants from embarrassment. We should note that some of the applicants have already disclosed that they have applied, making the attempt at secrecy a bit ineffectual and raising questions about why the applicants disclosed when the granting agency prefers secrecy.

The memo was prepared originally for use by the ink-stained wretches of the media, but it has value for anyone interested in the grants. You can clip it and post it on the outside of your petri dish.

MSU Clears Cibelli of Misconduct

Stem cell scientist Jose Cibelli, a member of one of the working groups of the California stem cell agency, has been cleared of misconduct by Michigan State University but it is not known whether he will return to his advisory work with CIRM.

Cibelli asked for the MSU investigation as a result of his connection with the Korean stem cell scandal. He was the co-author of the fraudulent March 2004 paper that reported the first-ever closed human stem-cell line.

A letter signed by the university intellectual integrity officer was provided by Michigan State University to the California Stem Cell Report. The letter said in part:

"The excerpts below summarize the findings of the IC(investigative committee):

'After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.'

"The report further states:

'His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.'"

Dale Carlson, spokesman for CIRM, told the California Stem Cell Report:

"Cibelli was an enthusiastic, valuable member of the group and we'd like very much to see him back."

Carlson added that further information would have to wait until CIRM President Zach Hall returns from a trip to Singapore.

Cibelli voluntarily withdrew from active participation in the standards working group after the Korean scandal erupted.

Below is the full text of the MSU letter concerning Cibelli. We have asked the university for a complete copy of the report that is referred to in the letter.

Text of Cibelli Letter

Here is the complete text of the letter supplied by Michigan State University concerning Jose Cibelli:

January 26, 2007

This letter is to inform you that Michigan State University has just completed its Investigation into the Allegation of Misconduct in Research against Dr. Jose Cibelli, Professor, Department of Animal Science and Physiology, under MSU’s Procedures Regarding Allegations of Misconduct in Research and Creative Activities. The Investigative Committee (IC) found that no Misconduct in Research occurred.

Immediately after learning that the paper he co-authored, “Evidence of a pluripotent human embryonic stem cell line derived from a cloned blastocyst”, Science 303:1669-1674, reported data from fraudulent research, Dr. Cibelli voluntarily went to MSU’s University Intellectual Integrity Officer (UIIO) seeking an evaluation of his contributions to the manuscript. Dr. Cibelli’s review included a Preliminary Assessment by the UIIO, an Inquiry conducted by three colleagues of an Inquiry Panel and a formal Investigation conducted by three colleagues who comprised the IC. Review of Dr. Cibelli’s case took approximately one year.

The excerpts below summarize the findings of the IC:

After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.

The report further states:

His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.

Please consider this finding of no misconduct in future interactions with Dr. Cibelli.

Sincerely,

James M. Pivarnik, Ph.D.
University Intellectual Integrity Officer

FTCR: No to Research and 'Big Name' for Next CIRM President

The California stem cell agency should not hire a "big name" as its new president, and he or she should not be allowed to conduct research on the side, according to one of CIRM's watchdogs.

John M. Simpson, stem cell project director for the Foundation for the Taxpayer and Consumers Rights, sent a letter to CIRM today and issued a press release on the subject, following the ealier item ("Move with Dispatch") below in the California Stem Cell Report. (Also see Simpson's comment on that item in which he quotes an unidentified Oversight Committee.)

In his letter, Simpson said:

"The next president must be an extremely competent hands-on scientific administrator, who can set up and maintain transparent and accountable management systems. He or she must be able to interact with the public, state officials, legislators and the media in a transparent, honest and accountable fashion.

"In the past there has been some suggestion that the president might continue to maintain research laboratory as part of the president's role. This should not be allowed. The presidency of CIRM is more than a full-time job. A person trying to manage CIRM's activities and conduct meaningful research simultaneously would do justice to neither activity.

"Members of the search committee should avoid the temptation of seeking a 'big name' scientists known for his or her discoveries. The emphasis must be on the individual's skill in scientific management and administration."

Simpson's statement came as CIRM posted a seven-page document on its Web site describing proposed criteria for the new president. That document, coming only one day before the meeting of the presidential search subcommittee, will serve as the framework for that panel's discussion. Other background information relating to hiring a search firm, whether that process should be open to bids, timetable for hiring and "interim action" was not available. The lack of that information makes it extremely difficult for the public to comment intelligently and belies CIRM's ostensible commitment to openness and transparency.

Much of what is contained in the presidential criteria document, which presumably emanated from the office of stem cell Chairman Robert Klein, is predictable. A preliminary look, however, raises suspicions about whether it is a first step in shifting the existing balance between the president and the chairman (see the section on management reporting lines of authority). The overlapping, dual leadership at CIRM has been a troubling aspect of the agency since its earliest days, surfacing in public conflicts involving Klein and current President Zach Hall, who is retiring by about mid-year. Prop. 71 codified the dubious executive structure in a state law that is nearly impossible to change without another vote of the people.

The 3 p.m. meeting of the search subcommittee will be in San Francisco, but remote locations are available to the public in Washington, D.C., Los Angeles, UC San Francisco, UC Berkeley, La Jolla, Ca., Carlsbad, Ca., Stanford University and the San Francisco city attorney's office. The agenda does not indicate specific room numbers in some cases. Email CIRM directly, info@cirm.ca.gov, or phone the agency at 415-396-9100 if you would like more details on the locations.

CIRM's Presidential Search: Time to Move with Dispatch

Should the next president of the $6 billion California stem cell agency also conduct research? Should he or she receive a higher or lower salary than the current CEO? Can a suitable successor be on board by June? Can good candidates be found who also can work in the dual leadership environment at CIRM?

Those are some of the questions likely to be addressed as CIRM's presidential search committee convenes on Wednesday with remote sites for the public available from Washington, D.C., to Chico, Ca.

The specific agenda for the meeting is a bit sketchy as of this writing, reminiscent of CIRM meetings of yore in which background material was not available until the day of the meeting, making it difficult for even CIRM Oversight Committee members to comment intelligently much less the public.

On the table are job summary and criteria, the search process and possible competitive bidding for a search firm, the time table and "interim actions." The last item would seem to involve a temporary appointment while the search for a permanent replacement for Zach Hall continues. The 69-year-old Hall has indicated he wants to be off the job no later than June.

The last presidential search in 2005 failed to produce a result until September of that year, three or four months after it had been expected. And that was a man, Zach Hall, already filling the spot on a temporary basis.

The tenuous legal position of CIRM, which then faced the lawsuit now on appeal, was one of the reasons for the apparent difficulty in hiring a president. Another matter of concern among some candidates was whether they could conduct research and whether CIRM would provide facilities. That came up in August 2005 at a meeting of the search subcommittee.

Issues involving the dual leadership at CIRM – a president and chairman with overlapping responsibilities – surfaced early in 2005 with the search subcommittee. It is likely to be a continuing concern although stem cell Chairman Robert Klein has indicated he may give up his post in 2008. But even if he does, another question arises: Who would replace him and can the next president hammer out a new working relationship with the next chair?

California is an expensive place to live, especially the San Francisco Bay Area, where CIRM is headquartered. So compensation becomes especially important for those from out of state. The CIRM salary scale drew protests as excessive in 2005, but it is not likely to be revised downward.

Most involved with CIRM seem to agree that Hall's performance has set a high standard. He laid the difficult groundwork that may have deterred some early candidates. His performance has also clarified for the the Oversight Committee what is needed in a president and creates certain expectations. CIRM is a tiny organization with about 20 employees, substantially fewer than the 29-person Oversight Committee that oversees it. Leadership changes are always difficult for any enterprise. But smaller organizations are more susceptible to disruption than larger ones with substantially more momentum or, for that matter, inertia. CIRM could suffer if too much time passes without a permanent replacement for Zach Hall.

What Will WARF Say This Year?

Today is the last day for saving $500 on registration for the The Stem Cell Meeting in March in San Francisco. Last year, this was the forum that triggered the WARF patent flap. Here is the registration page.