Egg Donor Proposal Stirs Concern; CIRM Says Language is 'Placeholder'

The Center for Genetics and Society Thursday raised “serious concerns” about some of the matters to be discussed at today's meeting of the research standards group of the $3 billion California stem cell agency.

CIRM, however, said the center has “misconstrued the intent of the proposed changes.”

In a letter to CIRM, the Oakland, Ca., organization center referred to preliminary language contained in a briefing paper for the group that dealt with compensation for egg donors, which is banned by CIRM. The draft language, which is intended to conform CIRM rules to others nationally, would “limit the payment restriction to donation of oocyctes provided specifically for research purposes.”

The center said,

“We were startled to see this for two reasons. As you know, both Proposition 71 and California law prohibit paying women to provide eggs for research. This proposed policy would mean that a woman undergoing egg extraction could be compensated or receive other valuable consideration as long as research is not the specifically stated purpose of harvesting her eggs. Diverting eggs for which payments have been made from the reproductive to the research context would be contrary to Proposition 71 and state law.

“We sincerely hope that this is an oversight. We ask the Standards Working Group to reject the proposed language and to clarify that paying women for eggs that will be used for research (beyond reimbursing their expenses) is contrary to law, and will not be done in California.”

CIRM posted a response to the CGS letter on the agency's website. In the response, CIRM referred to National Academy of Sciences guidelines and said,

“The language 'specifically for research' is a placeholder taken directly from the NAS Guidelines. The SWG (standards group) has consistently drawn from the NAS guidelines to provide a model for our regulations. This example is no different. This placeholder language is designed to support policy development. Any proposed regulatory language is subject to SWG review, ICOC approval, OAL review and public comment to ensure the regulatory language is consistent with the intent of the policy.”

Our take? We think CIRM's intent is clear. However, whether the proposed regulatory language achieves that goal is another question. We suspect more artful language will be developed as these proposed changes work their way through the regulatory process during the next few months.

CIRM is to be lauded for posting its 28-page briefing paper well in advance of today's meeting. That allows time for such parties as the Center for Genetics and Society and others to comment thoughtfully on the matters to be considered. It also allows time for CIRM to respond publicly in advance of the meeting. The upshot is likely to be better policy and better regulations and enhance CIRM's image as responsive to the public.

We should also note that the center's letter also raised concerns about the “prospective use for research of paid-gamete IVF embryos could create conflicts of interest for the physician attending an egg provider, and thus put her at increased risk.”

Correction

The “Prop. 71 Minutia” item on Sept. 16 contained a quote that referred to “advice” from the Little Hoover Commission that CIRM should lower its quorum requirements. A draft of the Hoover report contained that recommendation, but it was omitted in the final version. The final report said the super-quorum requirement was “restrictive” and “problematic” but said the problem would be eased by reducing the size of the board from 29 to 15.

Prop. 71 Minutia Stalls CIRM Again

SAN FRANCISCO – The board of directors of the California stem cell agency Tuesday failed to achieve a quorum and was forced to put off action on regulations tied to its ambitious, $210 million disease team grant round, the largest ever in CIRM history.

That means it will be at least another two weeks or more before the board can act on the IP rules that it needs for disease team project. The grants are scheduled to be awarded later this year.

The board has been handicapped for years by its super-quorum requirement, 65 percent of its 29 members. Tuesday, the quorum was 19 but only 18 answered the roll call during the special, teleconference meeting based here. Twenty-one had been expected. Without a quorum, the board cannot take legal action.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., said today that problems with quorums are a persistent and important issue at CIRM. Simpson has followed the matter for several years. In one case in 2008, he wrote about how the board “essentially” drafted a member of the audience to raise a quorum.

Commenting today, he said,

“This clearly shows that (the board) has not resolved its nagging problem with mustering a quorum. They should have taken the Little Hoover Commission's (initial) advice and moved to make a simple majority all that is necessary to conduct business. Instead, they insist on a meaningless charade that wasted the time of 18 very busy people.”

The quorum mandate is written into state law by Prop. 71, which created the stem cell agency in 2004. It cannot be changed without a vote of the people or by the legislature. But the latter involves another super-majority requirement, 70 percent of both houses of the legislature and the signature of the governor.

The Little Hoover Commission, the state's government good government panel, earlier this year cited CIRM's problems with achieving quorums. But the CIRM board last month rejected suggestions that the quorum be reduced to 50 percent. It relied on its attorney's opinion that to do so would “undermine” the intent of the voters and would leave the board open to being captured by a minority.

However, super-majority requirements actually facilitate minority dominance of bodies such as the CIRM board. On Tuesday, the absence of one member paralyzed the board. In other cases, a few members have left CIRM board meetings and thus prevented it from taking action. Conceivably, 11 members of the board could control it by simply refusing to attend unless their wishes prevailed.

The regulations under consideration Tuesday dealt with intellectual property requirements. Initially, they appeared to be relatively non-controversial, although CIRM director Susan Bryant, vice chancellor for research, University of California, Irvine, raised anew concerns expressed last July by the University of California (statewide).

Director William R. Brody, president of the Salk Institute, also criticized some of the proposed regulations as “absurd” and suggested that language from federal IP law be adopted. However, others noted that CIRM deliberately moved away from federal law in its development of the regulations over several years.

In the absence of a quorum, CIRM Chairman Robert Klein said the proposed regulations will be taken up later after CIRM director Ed Penhoet, head of the IP Task Force and a co-founder of Chiron, has a chance to discuss them with Brody and Bryant.

The CIRM board also did not act on hiring underwriters (more than one is needed because of potential conflicts of interest) to run its $500 million biotech loan program. The effort is scheduled to begin with the disease team grant round. But the board was told that a very small number of potential borrowers are involved in that round.

Instead of hiring two or more underwriters, John Robson, CIRM vice president for operations, said the lending effort can begin with a pilot project involving one underwriter. He said that it will help the agency develop a better underwriting effort for the directors to approve next year. Following the meeting, Robson said he hopes to conclude a pilot agreement within days.

You can read more on quorum problems, as discussed by Simpson, here, here, here, here and here.

(Editor's note: In an earlier version of this item, the quotation from John M. Simpson did not contain the word "initial" in parentheses.)

Eggs, Donors, NIH Rules and More This Week

For those of you interested in research standards and rules, the California stem cell agency has posted 28 pages of background material for its meeting in San Francisco this Thursday and Friday.

On the agenda is New York's policy that permits compensation for human eggs to be used for research. CIRM does not permit compensation(valuable consideration), but the agency plans to make some changes in its rules to conform to national standards.

Also available via the CIRM web site is briefing material on proposed changes for donor consent requirements and an update on the NIH rules for human embryonic stem cell research, plus more.

CIRM CEO To Gain More Power in Grant Reviews

The president of the California stem cell agency would wield more power in the agency's grant review process under a proposal that was approved by CIRM's Grant Working Group earlier this month.

The proposal, which will probably go before the CIRM board of directors in October, would give CIRM CEO Alan Trounson the authority to pick an “acting” chairman to preside over each grant review session.

Currently responsibility for the reviews lies with the existing position of chairman, which will be eliminated in its current form. That post has been vacant for nearly a year.

Instead two types of chairs will be created. An “administrative” chair would be named to handle chores other than grant application reviews, which are the chief function of the Grants Working Group. The acting chairs would handle the review sessions. The board of directors would retain authority to approve the administrative chair.

The grants group makes the de facto decisions on CIRM grants, which are expected to total $1 billion by the end of the year.

Correction

The “More Clout” item on Sept. 8 incorrectly stated that the CIRM president will have the ability to appoint an administrative chairman for the Grants Working Group under proposed changes in the group's bylaws. In response to a query, CIRM spokesman Don Gibbons said the current responsibilities of the existing chair are being split between an administrative chair and various acting chairs.

CIRM Airs Powerful Patient Video

With some regularity, the board of the California stem cell agency hears directly from some of those afflicted with diseases and conditions that are among the targets of its $3 billion in research.

All of their stories are emotional, sometimes heart-rending.

The CIRM staff recently captured on video one of the more powerful presentations at its meeting in San Diego last June. Called “Spotlight on Leukemia,” it is now available via CIRM's YouTube site.

The video is a fine piece of work that tells a strong human story and well supports CIRM's mission.

Don Gibbons, CIRM's chief communications officer, aired the video at last month's CIRM board meeting. He said,

“Amy Adams led the story direction and Todd Dubnicoff did the amazing video editing.”

It is narrated by Geoff Lomax, senior officer for the CIRM Standards Working Group.

CIRM Nearing Agreement on Underwriters for $500 Million Biotech Loan Program

The board of the California stem cell agency will hold a special, teleconference meeting next Tuesday to consider hiring a bank or two to run its new and ambitious $500 million biotech lending program.

Also on the agenda are revised IP rules dealing with affordable access to taxpayer-financed stem cell therapies, although there appears to be no controversy about the rules at this point.

CIRM had hoped to have the bank underwriters in place by now for its $210 million disease team program, the largest research round ever for CIRM. Applications for that program are being reviewed behind closed doors today through Friday in San Francisco by the CIRM Grants Working Group.

Three banks were under consideration to run the biotech loan effort. They were Comerica, Square One and Silicon Valley Bank. The first two provided the lowest cost estimates, with Comerica coming in at $71,000 for handling a $20 million, six-year loan. More than one bank is expected to be hired because of the potential for conflicts of interest.

At the August CIRM board meeting, John Robson, vice president for CIRM operations, said that once the agency had some sort of initial agreement in place with Comerica and Square One, negotiations would follow with Silicon Valley Bank.

CIRM Chairman Robert Klein, who originated the concept for the biotech lending program, stressed the importance of moving forward with Silicon Valley Bank. He said,

“Given the tight time frame, moving forward with Silicon Valley Bank is going to be important, if feasible, so that the board really has the full choice and the cost differences in front of them when they are asked to approve the delegated underwriters. With a prototype process, we will and have run into some issues with these banking institutions as they've -- their legal departments have understood the complexity of dealing with the state. So we need to bring forward, to the extent we can, all three opportunities for the board so the board can make a decision.”

CIRM is seeking to hire a bank to run the program because the agency does not have the expertise or the staff to do the work. The banks would perform an analysis of business applicants, assess their operations and management and make recommendations.

CIRM plans to lend money to risky enterprises that otherwise could not secure financing. Loan failure rates of up to 50 percent in the program have been predicted by CIRM.

The first loans are scheduled to go out following formal approval later this year of winners in the disease team program.

The IP rules that are also under consideration next week stirred a flap at one point. The board, however, last month rescinded the controversial proposed changes.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., and who raised the earlier concerns, says he is satisfied with the current proposed changes.

The public can listen to and participate in the board meeting at a number of locations throughout the state. Their specific addresses can be found on the agenda.

A transcript of last month's brief discussion of the biotech loan program can be found here.

Correction

Based on incorrect information on the CIRM Web site, we stated in the “CIRM President to Gain More Clout” item that Stuart Orkin was chairman of the stem cell agency's Grants Working Group. Orkin says he resigned as chairman last November and is no longer on the panel. According to CIRM, Rainer Storb of the Fred Hutchinson Cancer Research Center served as acting chair at the last meeting of the group and is presiding over the meeting underway today in San Francisco. CIRM has also corrected the information on its Web site.

Advisory/Correction

Based on incorrect information on the CIRM Web site, the item below states that Stuart Orkin is currently chairman of the CIRM Grants Working Group. However, he told us in an email that he resigned last November and is no longer on the panel. We are querying CIRM concerning the current status of the chairman's position.

CIRM President to Gain More Clout in Competition for Millions in Grants

The California stem cell agency is moving to strengthen the hand of its president in the review of applications for hundreds of millions of dollars in grants.

The proposal comes before the agency's Grants Working Group tomorrow morning at a two-day meeting in San Francisco to consider applications for its ambitious $210 million disease team program, the largest single research grant round in CIRM history.

The grants group makes the de facto decisions on CIRM grants, which will total about $1 billion by the end of this year.

The group operates behind closed doors for review of applications, but the move to alter CIRM's review process will be considered and voted on in public.

According to a staff memo, the new procedures would allow CIRM President Alan Trounson to pick “acting” chairs to head each grant review session. The selection would be made from either regular or alternate members of the grants group.

It was not clear what responsibilities would remain in the hands of the existing chair position. The exact language of the proposed changes in the group's bylaws was not available on the CIRM Web site at the time of this writing.

Currently the grants review chairman is appointed by the CIRM board of directors and has sole authority to preside over scientific evaluation of grants. The position of chairman has been vacant since last November.

The CIRM staff memo said changes are called for because the $3 billion agency is broadening its research to include translational, preclinical and clinical trial programs.

CIRM said,

“Consequently, there is an important need to have chairs of CIRM review panels with the expertise and seniority that is complementary to the type of RFA being considered.”

The agency also said it is impractical to have one person lead the five to seven review meetings in San Francisco each year. CIRM said similar NIH review groups rarely meet more than twice a year.

The proposal follows CIRM board approval of changes last month in compensation for review group members that could provide perhaps $4,500 or so per grant round per scientist, depending on payment decisions by CIRM staff.

(Editor's note: Based on inaccurate information on the CIRM Web site, an earlier version of this item incorrectly stated that Stuart Orkin was chairman of the Grants Working Group. Orkin says he resigned as chairman last November and is no longer on the panel. At the time of this posting, CIRM said that the position remains vacant and has been filled over the last 10 months by others on an "acting" basis. CIRM has also corrected the information on its Web site.

(The earlier item also incorrectly stated that Trounson would appoint the administrative chair. That responsibility will remain with the CIRM board. )

Shestack's Words Stir Ire in York

One of the directors of the California stem cell agency has become embroiled in a flap about billboards in a small Pennsylvania town better known for making Harleys and animal crackers than for scientific research.

The director is Jonathan Shestack, a nationally known autism patient advocate and Hollywood film producer (Air Force One). The town is York, home to a motorcycle factory and the Stauffer Biscuit Co.

The matter involves a quotation from Shestack, who has been known to speak his mind at CIRM board meetings. In this case, Shestack's 16 words were emblazoned in yellow on a billboard on Route 30. He said,

"If 1 in 150 American children were kidnapped we'd have a national emergency. We do. Autism."

Jeff Frantz of the York Daily Record wrote,

"The Autism Self Advocacy Network and several autism bloggers from around the country objected to the billboard, saying the quote equated an autism diagnosis with a lifetime prison sentence. "

Frantz also reported,

"'You know what, I stand by it all,' Shestack said. 'It is a phrase to grab people by the throat.'

“Those objectors are often people with high-functioning autism, he said. They ignore half of those with autism like his son, who will never learn to speak and will always need help with basic tasks.

"'I think the people who object are small-minded, not generous and only see the world through their own experience,' Shestack said.”

We agree with Shestack.

But the Autism York group, which put the billboard, is not buying Shestack's view and is taking the sign down.

Research VP Slot Posted at California Stem Cell Agency

The California stem cell agency has posted its opening for the newly created position of vice president, research and development, with a salary range that tops out at $332,000 annually.

The person who fills the slot is likely to be the key staff person as CIRM moves more closely to the biotech industry as the agency speeds its drive to produce something that can be used to treat patients.

Here is part of the job description:

“Oversee the preclinical and clinical development phases of CIRM's programs and projects involving not-for-profit and for-profit teams, including assembling and working closely with CIRM advisory committees to provide oversight of these programs and make go/no go recommendations to the President for continuation of CIRM support.

“Works closely with biotechnology, pharmaceutical and investment sectors to enable and enhance the development of clinical applications in CIRM's scientific portfolio.

“Oversees the CIRM research and development program in close collaboration with the Executive Director of Scientific Activities”

Earlier, CIRM President Alan Trounson indicated he was looking for someone with considerable commercial experience, especially related to clinical trials.

Interested parties might also examine the transcript of the CIRM directors meeting Aug. 6, during which Trounson discussed the position.

No deadline was set for applications. The posting said the position will remain open until it is filled.

CIRM Backs Public Option in Health Care Reform

The board of the California stem cell agency has endorsed a public option as part of the national health care insurance reform effort, a move that a backer said would help with affordable access to any stem cell therapies developed with taxpayer funds.

The board took the position last week on a motion by director Jeff Sheehy, a communications manager for UC San Francisco. He sits on the board as a patient advocate. Sheehy said,

"It's a way to keep private insurance companies honest and is essential to holding down costs in insurance."

The action was praised by John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca. In an item on his organization's blog, he said,

“I certainly haven't agreed with everything the ICOC has done, but they sure got this one right. Let's just hope they expend as much effort making this action known in Washington, D.C., as has gone into touting their biotech-friendly, anti-consumer position on biosimilar drug legislation.”

Good Faith, Loopholes and CIRM

SAN FRANCISCO – The $3 billion California stem cell agency says a headline carried last week by the California Stem Cell Report is “damagingly misleading” and would like a correction.

We disagree and will tell you why. But the matter goes beyond a mere eight words. It deals with trust, good faith and more.

The headline in question is: “CIRM Rolls Back Effort to Undercut Affordable Access.”

The subject involves a proposed – but now retracted – major change in CIRM intellectual property regulations. The revision was quietly fast-tracked for what would have been final approval last Thursday by the CIRM board at its two-day meeting here. Fortunately, the loophole was caught the day before the meeting by John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca. He wrote a letter challenging the revision. We published an item on his comments along with the text of his letter. As a result, the proposal was pulled back.

Simpson has been deeply involved in the CIRM proceedings that hammered out the IP rules and their provisions for affordable access. The process took place over several years, and CIRM directors have repeatedly reaffirmed their commitment to affordable access to any taxpayer-financed therapies. Affordability is also part of the promise of Prop. 71, the ballot initiative that created CIRM. Simpson has publicly praised the CIRM IP process for its openness and diligence and has expressed great respect for IP Task Force Chairman Ed Penhoet.

On Wednesday, the day after Simpson discovered the loophole, Chairman Robert Klein called Simpson to tell him that the offending provision was being dropped. Klein also mentioned it to us at the meeting here later that day. But loophole did not come before the full board until late in the meeting the next day.

No one at the session disputed Simpson's conclusion that the change in wording was a “tremendous loophole” that would endanger affordable access and also could prove to be a major benefit to the biotech industry.

Rather CIRM's question concerning our headline involves the intent of changing previously agreed upon language. The matter also involves whether CIRM was honoring its principles by advancing the proposed change in a manner that appeared surreptitious, at the least. The revision was buried in 491 lines of prolix regulatory language that was described on the board's agenda as merely a “consolidation” of previous regulations.

The loophole – which involved only a few words – was also proposed at a time when CIRM is aggressively moving to embrace the biotech industry. According to its strategic plan, it will take a leading role – at taxpayer expense – to lobby nationally to remove barriers facing the industry. All with the good intent, we should add, of speeding cures.

When the proposed revision came up during Thursday's board session, Elona Baum, CIRM's new general counsel who joined the agency in April after 12 years with Genentech, said that questions had been been raised about “sublicensing.” She said, “In the interests of clarity, the language was inserted.”

CIRM directors then formally acted to remove the offending language, which will go out for a 15-day public comment period before becoming official.

Shortly after Baum offered her comments, Don Gibbons, chief communications officer, sent me the following email about the headline in question.

“Having heard this discussion, I would hope you feel it is appropriate to self correct this damagingly misleading headline. It should have been clear this was never CIRM’s intent.”

The CIRM board, which is the ultimate authority at the stem cell agency, is to be commended for removing the loophole. But how and why the language was inserted is a matter in dispute.

Gibbons is paid $190,00 a year to polish CIRM's image. We understand why he does not care for our wording. However, both Simpson and I have been given to understand that the loophole did not result from merely a lack of legal felicity.

We asked Simpson for a comment on Gibbons' opinion concerning the headline. Here is what Simpson said,

“Either the lawyer responsible for the proposed change in the definition didn’t understand its implications, which implies incompetence or the lawyer completely understood, which implies deliberate intent to make substantive policy changes and subvert the process. Neither choice is pleasant, so I’ll simply celebrate the fact that when the ICOC (the CIRM board), particularly the members of the IP Task Force, was made aware of the situation, it was immediately rectified.”

Last Tuesday, we asked Gibbons for a comment on behalf of CIRM concerning the loophole. He never responded. We are asking him if CIRM has any comments on this item. We will carry any response verbatim.

Who Will be the Lucky Eight?

SAN FRANCISCO -- The board of the California stem cell agency today approved a $44 million recruitment effort to lure a handful of “paradigm-shifting” scientists to the Golden State.

The program, which will kick in early next year, was adopted on an 18-2 vote. It was supported overwhelmingly by CIRM directors from institutions that are likely to benefit from the plan, which will provide packages perhaps as large as $4.5 million for possibly eight stellar scientists.

No legal conflicts of interest prevented medical school deans and others from voting on a “concept” proposal that could benefit their universities, research institutions or medical centers, according to CIRM lawyers.

The proposal was modified slightly from the initial plan to remove a limit of four awards per year. Also removed was wording that would have prevented awards to scientists who are more than 10 years past their postdoctoral positions.

In his first comment as a new member of the CIRM board, William Brody, president of Salk, said the program would be a good investment, helping to populate the new labs being built in California with $271 million from CIRM. He agreed with numerous other board members who said the program would lure “franchise players” and “paradigm-shifting” researchers, the type who would “ask the big questions.”

The recruitment effort is also aimed at helping the University of California and other institutions facing financial hardships.

The heart of the two-year proposal -- the cash -- did not generate significant opposition. Questions were raised, however, about the procedures, such as using a telephonic instead of a physical meeting of a special grants review group to act on nominations for the grants.

Earlier we reported that stem cell scuttlebutt has it that Kevin Eggan and Amy Wagers, both of Harvard, are possible targets of the recruitment effort.

CIRM directors did not discuss publicly whether the lavish recruitment effort would sour their relations and collaborations with other states and institutions, some of whose leading figures serve on CIRM committees.

CIRM Directors Approve $16 Million in Basic Research

SAN FRANCISCO -- The California stem cell agency today ratified decisions by its scientific reviewers to approve $16 million for basic biology research, trimming the program back from its original proposed $30 million.

Directors were told that scientific reviewers did not think additional funding was justified, based on the quality of the applications.

CIRM has posted a news release with the names of the 12 recipients. The grants all went to institutions that have representatives on the board of directors. However, none of the directors could vote specifically on the grants to their institutions.

Directors rejected attempts to fund two additional grants – 1298 and 1339 – that were not supported by reviewers.

Geron Travails a Reminder of Height of Stem Cell Hurdles

For those you who haven't seen the latest news on Geron, their latest hiccup -- if that is what it is -- demonstrates the arduous and tedious nature of bringing new stem cell therapies into the market.

Geron's plan to run a modest clinical trial on its spinal cord injury therapy has been suspended – before one person could be enrolled – as the result of FDA action. If it ever gets underway, it would be the first human trial using embryonic stem cells.

The company, which is based in Menlo Park, Ca., gave no reasons nor did the FDA, but one analyst cited possible safety concerns.

Geron has been in existence since 1990. It has never made a profit. It has no commercial products. And it has spent more than $150 million developing its spinal cord therapy, according to Steve Johnson of the San Jose Mercury News.

Geron has benefited from favorable coverage since announcing eight months ago it would start the trial. Adam Feurstein of TheStreet.com has a much more jaundiced view. However, he downplays the safety issue.

CIRM Rolls Back its Effort to Undercut Affordable Access

SAN FRANCISCO – A move that would have undercut efforts to provide affordable access to stem cell therapies financed by California taxpayers has been thwarted.

The effort was dropped after John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., brought it to light.

Simpson reported on his organization's blog tonight that CIRM Chairman Robert Klein telephoned him to say that regulatory language proposed by CIRM that would have created a “tremendous loophole” for biotech companies has been scrubbed.

Klein confirmed that action to the California Stem Cell Report at its meeting here tonight. Simpson and his organization are to be commended for bringing the move to public attention.

More details of what transpired can be found on Simpson's blog.

CIRM Directors Wrestle with Strategy and Ties to Business

The Chinese calendar calls this the year of the ox. At the California stem cell agency, however, this is the year of cozier relationships with the biotech industry.

At a two-day San Francisco meeting that begins tomorrow, the $3 billion state enterprise will re-examine its strategic plan with an eye to strengthening its ties to industry. CIRM's intent is to push taxpayer-financed stem cell therapies into the marketplace and actually treat people – but not necessarily right away. That probably won't happen for 10 to 14 years, according to its plan. Science and regulators are slow.

The plan (here and here) covers a lot of ground, ranging from CIRM's goal of a creating a “stem cell culture” in California to beefing up the management of its burgeoning portfolio of grants, which is expected to hit $1 billion this year.

But the overriding theme is closer ties to industry. A new and highly paid vice president will be handling them. CIRM will lobby increasingly on behalf of industry. The agency will implement an unprecedented, $500 million lending program for the riskiest biotech firms. And it will recruit scientific grant reviewers who understand “what is necessary for commercial success.”

Nothing is wrong with this, in principle. In fact, we think CIRM early on was not aggressive enough in engaging business. Only tiny numbers of industry representatives have appeared at CIRM meetings. Few companies have been successful in winning CIRM grants. And rejected business applicants have complained bitterly about the process.

Business must be firmly engaged with CIRM in order to develop therapies. But the marriage of business and government is fraught with peril. The best of intentions can go awry. They seemed to have done so with proposed creation this week of “a tremendous loophole” in the agency's earlier regulations to ensure affordable access to taxpayer-financed therapies.

John M. Simpson has observed CIRM for several years as the stem cell project director of Consumer Watchdog of Santa Monica, Ca. He and others we talked to have expressed concern about the vagueness of the strategic plan's proposals about industry. In response to a query, he said,

“The strategic plan envisions greater ties with the business community without providing enough specifics of how it all will work. Implicit in the plan seems to be the idea that if businesses are not taking CIRM's money it is a failure on CIRM's part and CIRM needs to loosen its rules.

“This loses sight of the fact that CIRM plays a regulatory role. In fact, if businesses want taxpayer dollars, businesses need to abide by CIRM's well-crafted regulations.

“CIRM seems to be saying we'll keep changing the rules, until you come and play with us. CIRM needs to understand if you go too far down a path of accommodation, the game isn't worth it.”

As part of the plan, another observer says that it would be useful for CIRM to survey activity in California's private sector concerning stem cell research. And, he said, more details are needed on CIRM's role in clinical trials and just exactly how it will help industry in connection with the FDA.

Earlier this year, CIRM's apparent move away from basic research triggered concerns among some scientists. They argued that it is too early to push most research into clinical trials. For example, the agency this year will approve a $210 million disease team grant round, its largest ever single research grant round. CIRM's plan reaffirms a commitment to basic science, but whether that allays fears of critics remains to be seen.

One matter that may trouble many scientists is what may be a reluctance to share information outside of the CIRM research community. The strategic plan discusses sharing “instructive negative research” results within its own community. And it says,

“To manage the flow of information, CIRM is developing and implementing a categorization system and database to store information according to disease relevance, cell types and technologies employed, research results, questions raised and answered and possible next steps.”

In neither of those two examples does CIRM specifically say the information will be shared outside the CIRM community or with the public. That may be an oversight, but it would useful to have some assurance that the information will be publicly accessible.

The latest revision to the strategic plan also presents scientifically justified movement away from its original charter – funding work related almost entirely to hESC research. In fact, the word “embryonic” only appears 20 times in the plan's 37 pages. That may be disappointing to some patient advocates, who may also not be pleased with the 10 to 14 year timetable for therapies.

Simpson additionally identified one objective in the report that he took issue found dubious. He said,

“As a scientific goal CIRM pledges to 'encourage the development of a 'stem cell culture' in California...'

“That makes about as much sense as if NASA said it planned to encourage a rocket science culture in the United States.

“The notion of a 'stem cell culture' becomes even more troublesome when you consider the hype that has been all too common in the field.”

(The strategic plan will be taken up at a two-day meeting of the CIRM board that begins Wednesday in San Francisco. The public can participate in Southern California at a location at the City of Hope in Duarte. A Web audiocast is also available without the possibility of participation. See the agenda for details.)