CIRM IP Legislation Begins Its Journey to Mixed Reviews

The chair of the California State Senate Health Committee today formally unveiled her legislation aimed ensuring the state receives a return on its $3 billion investment in stem cell research. But the measure initially met with mixed reviews.

One potential ally wanted more and foes want less. CIRM itself said no comment would be forthcoming until it had seen the official text of the legislation (SB771), which is not available at the time of this writing.

The bipartisan bill, as presented in the press release by Sen. Sheila Kuehl, D-Santa Monica, seemed to measure up to earlier information (see "CIRM Regulation").

John M. Simpson, stem cell project director for the Santa Monica-based Foundation for Taxpayer and Consumer Rights, said,

"The bill does not go far enough to ensure that all Californians have affordable access to the cures and treatments that result from stem cell research they are funding.

"There needs to be a provision that allows the attorney general to intervene if these therapies, treatments or cures are priced unreasonably.

"It's good that the bill would require an an access plan for uninsured people and that it would require purchases funded with public funds be made at the Medicaid price. The problem is that it doesn't do enough for all Californians who are paying to develop these treatments with their hard-earned tax dollars."

Jesse Reynolds, project director on biotechnology accountability for the Oakland-based Center for Genetics and Society, welcomed the measure, declaring,

"If a biotech company is making billions of dollars of profit from state-financed research, the people should receive a fair return on their investment, as well as access to any therapies."

Reynolds said the leadership of the stem cell agency has tried to "back out" of Prop. 71 campaign promises of huge economic returns to the state. He said,

"This would have been a billion-dollar bait and switch. The bill will make significant steps toward fulfilling these promises."

The California Healthcare Institute, which represents the state's biomedical industry, did not have an immediate comment. But the group is already opposed to CIRM intellectual property policies, which Kuehl says are too weak.

CHI says on its stem cell research page that CIRM's IP rules

"threaten to discourage commercial collaboration, technology transfer and licensing by (a) increasing the administrative complexity of licensing agreements involving CIRM-funded technologies in comparison to the mainstream of academic-industry transactions, which derive from federally-funded research, and (b) increasing investors' financial risk by imposing state price regulation on downstream products."

We should note that not all companies involved in development of the CIRM IP rules share CHI's adamant opposition to CIRM's IP rules. (CHI's stem cell page contains several links to more of its documents filed concerning CIRM IP.)

Kuehl drummed up some media attention in advance, granting interviews to both the San Jose Mercury News (see "CIRM Regulation") and Terri Somers of the San Diego Union-Tribune. Somers quoted Kuehl as saying,

“Californians are putting billions of dollars into this research. They ought to be guaranteed to get a little bit back, because everyone else is going to be on the take."

For more on the legislation, including the difficult task Kuehl faces, see "Rationale Behind" and "Legislators Target."

CGS: Grant Process 'Deeply Flawed' and 'Embarrassing

The Center for Genetics and Society did not mince words about the California stem cell agency and its award last week of $45 million in research grants.
'
Writing today on the group's blog, Biopolitical Times, Jesse Reynolds,
project director on biotechnology accountability for the Oakland-based group, began by saying the process "was not without significant shortcomings."

Then he said it was "deeply flawed" and "embarrassing."

Flawed because, he wrote:

"The members of the grant review panel are still not required to publicly disclose their personal financial interests, leaving the door open for conflicts of interest. (The agency, however, did take the step of indicating which members of the review panel were recused from which application review.) This panel is supposedly advisory, because the program's governing board, the ICOC, is required to give final approval of the grants. But in fact, the ICOC voted on many of them in blocks and did little more than demarcate a funding line in the ordered rankings of the 'advisory' review board. This makes the grant review panel a de facto decision-making body, which by California law must disclose personal financial interests."

He continued:

"Finally, during the most high-profile meeting of the ICOC since the inception of the stem cell research program, the board struggled to maintain a quorum. It was not met at all on the first day of the two-day meeting, during which grants were approved by 'provisional votes.' These were confirmed en masse the next day, when there was barely a quorum. This is embarrassing. The ICOC needs to adopt attendance standards."

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
during the next few days. In addition, Google, the service that hosts
this web site, has some issues with its software that create
difficulties in posting items. We are using an alternative method of
filing items that may result in some different, perhaps even weird
formatting.

"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.