Fresh Comment

We have filed a response to John M. Simpson's comment on the “Honesty, Science and Politics” item. Among other things, our response says the No. 1 objective of CIRM right now should be to make sure it has cash next fall to pay its grantees.

Fresh Comment

John M. Simpson of Consumer Watchdog has posted a comment on the “Honesty, Science and Politics” item. Among other things, he says that when California voters approved Prop. 71, they did not expect to see an agency that would become “a platform for worldwide stem cell advocacy by Chairman Bob Klein.”

CIRM Legal Costs Climb Towards $1 Million

Legal costs at the California stem cell agency are heading towards the $1 million mark this year and could well go higher as it embarks on an ambitious and unusual plan to market state bonds to dig itself out of a financial hole.

Next Thursday, the Governance Subcommittee of the CIRM board of directors is expected to increase payments for its main outside counsel, Remcho, Johansen & Purcell, of San Leandro, Ca., and also for Nancy Koch, who deals with intellectual property issues.

According to the most recent document from CIRM, as of Nov. 30, 2008, Remcho had already been paid $237,545 out of its $450,000 contract for the 2008-09 fiscal year. Also as of Nov. 30, Koch had been paid $82,306 out of a $150,000 contract for this fiscal year.

Their contracts and possibly other legal assistance agreements are up for "amendment" at next Thursday's meeting. The use of that word generally means that CIRM needs authorization for more cash to pay the lawyers.

According to CIRM's Dec. 22, 2008, report on outside services, total contracted legal services for the fiscal year amount to $812,930, including $140,431 for the California State Department of Justice. Not all of the total has been spent, but the budget did not anticipate the need for CIRM to engage in attempting to place state bonds with private investors.

CIRM's annual operational budget, which does not include grant payments, totaled about $13 million when approved last July. The currently contracted legal expenses amount to roughly 6.2 percent of the budget. The agency has also not filled the position of general counsel, which became vacant Aug. 15. It is still looking for a person to fill that position, which is now described as general counsel to the president.

CIRM will run out of money in about seven months unless it generates additional cash. That's because the financially troubled state of California has stopped selling the bonds that CIRM relies on to finance its operations and pay for research.

What Bob Klein and CIRM Owe George Bush

Here is what Hank Campbell, the major domo of scientificblogging.com, says,

 "Whether you agreed with Bush or not, his restrictions on stem cell research were good for science - California alone threw $3 billion at human embryonic stem cell (hESC) research for no other reason than that Bush was against it, something that could never have occurred through the NIH, and scientists also found creative alternatives, also something that would probably not have happened."

Honesty, Science and Politics

Part of the justification for the existence of the California stem cell agency lies in the argument that scientific research should be above politics and government and apart from it.

However, science has rarely been apart from politics – at least in the last 50 or 60 years in this country.

New York Times columnist John Tierney dealt with the intersection of the two in a Monday piece – headlined "Politics in the Guise of Pure Science" -- in which he raised questions about whether some of President Obama's scientific advisers can be "honest brokers."

He quoted Roger Pielke(see photo) of the University of Colorado on the matter, whose book, not so coincidentally, is entitled "The Honest Broker." Tierney said Pielke argues that "most scientists are fundamentally mistaken about their role in political debates. As a result, he says, they’re jeopardizing their credibility while impeding solutions to problems like global warming."

Tierney wrote,

"...(T)oo often, Dr. Pielke says, they pose as impartial experts pointing politicians to the only option that makes scientific sense. To bolster their case, they’re prone to exaggerate their expertise (like enumerating the catastrophes that would occur if their policies aren’t adopted), while denigrating their political opponents as 'unqualified'or 'unscientific.'"

Tierney cited recent statements by John Holdren and Steven Chu as examples. Tierney did not discuss human embryonic stem cell research in his piece, but he could have.

The case for hESC research is often imbued with messianic zeal and rhetoric about "missions" that seems more appropriate to an ideology rather than cold, hard scientific research. Hyperbole does not necessarily serve the public or scientists well over the long term, perhaps not even in the short. Instead, it can become a justification for spending on ill-considered, dubious efforts advanced to attain some sort visionary goal. Pielke's and Tierney's cautions are something for the overseers of California's $3 billion stem cell research program to keep in mind as they evaluate the agency's efforts in the next few months.

(Editor's note -- Tierney's column drew 156 comments at the time of this writing. You can read them here).

Operator Error on Loring Comment

A kindly reader pointed out that the Loring comment could not be found on "Obama Chapter Two." That was an error on the part of this operator. Her comment is now available.

Burrill Says Biotech Industry Profitable for First Time in History

The big headline from the influential Burrill & Company merchant bank is "Biotech Scores Black Ink" for the first time ever.

According to Peter Winter(see photo), editor of the Burrill Report, the biotech industry turned profitable in 2008. Winter made this "startling discovery" after analyzing the numbers for 360 publicly traded biotech companies. Presumably the conclusion might change if private firms were included.

The Burrill finding is another piece to consider in the case for and against the $10 billion biotech federal assistance package championed by CIRM Chairman Robert Klein.

However, Winter also said that only 67 of the 360 companies were profitable with the largest sums coming from only three companies: Genentech, Amgen and Gilead.

He said the have-not companies are struggling, and he predicted that a year from now, perhaps only 200 of the 360 companies will survive.

Burrill did not offer a text version of Winter's findings -- only a podcast. We respect Burrill and the authoritative information it provides, but we regard podcasts and recorded videos as a cyberspace abomination when it comes to dispensing information. When recordings replace carefully crafted, written analysis, they are an inefficient, inadequate and miserable substitute.

Just consider the numbers: Normal speech runs about 150 words a minute. Question-and-answer interviews, including trivial remarks, take longer. Downloading and listening to the Q&A with Winter took about 9-10 minutes. In that time, we could have read about 6,000 or 7,000 words or more. We also assume that nearly all the readers of this blog and the Burrill website can handle written information much more rapidly than listening to oral presentations, which often miss important details and nuances. The discipline of writing almost forces the inclusion of those elements.

Recordings on the Internet have their place and can communicate certain kinds of emphasis and emotion better than text. But for the most part, they are used on the Internet like some new gadget, whose novelty is more alluring than its effectiveness.

Serious enterprises that deal with hard facts and numbers should avoid them. That's the conclusion from the California Stem Cell Report in our cyberspace rant of the day.

Fierce Biotech Poll: No Bailout for Biotech

A week-long poll by an industry publication shows that most respondents do not favor a federal bailout of biotech firms, with one reader commenting that "it's all about the survival of the fittest and smartest."

The informal poll was conducted online by Fierce Biotech. It showed that 51 percent answered no to the question "Does the US biotech industry deserve a bailout?" Forty-four percent said yes. Five percent said no.

The results of the poll have some implications for the California stem cell agency and the lobbying effort by its chairman, Robert Klein, to snag $10 billion for the biotech industry. He has already hired a powerful Washington lobbyist, the Podesta Group, for $200,000 to secure the package.

Maureen Martino(see photo), editor of Fierce Biotech, wrote about the poll, quoting some persons who emailed her.

Elinor Gulve was one of those. She wrote,

"Things have to play out in nature's own course. In this industry, it's all about the survival of the fittest and smartest."

Martino said,

"Readers expressed concerns about how the money would be distributed, and whether those government dollars would come with serious strings attached. Several respondents felt that the industry deserves government support, but that it should come in the form of tax incentives and funding for agencies like the NIH--not from a handout."

The poll was not a scientific random sample, just an expression of sentiment from those who felt strongly enough about the matter to respond, Nonetheless it was a bit surprising since the respondents presumably came from the industry and had the most to gain from dollops of federal dough. Results on polls are also shaped by the wording on the questions. If the question were phrased as: Was a bailout "needed" or would it be "useful" to the industry, the results might have been different.

We wrote earlier about this poll after it had been up for only a few days. The early trend was about the same as the final results after seven days.

Fresh Comment

Jeanne Loring, director of the Center for Regenerative Medicine at Scripps, has posted a comment on the "Obama: Chapter Two" item. Among other things, she says that legislative is needed to change federal law on stem cell research.

California Bond Picture Not Too Bright, Say Bond Managers

A couple of bigtime bond investors are shrugging off the California budget deal, reflecting sentiments that do not appear to augur well for the state stem cell agency's plan to sell state bonds privately to solve a cash crunch.

Reporter Martin Braun, writing for Bloomberg News, quoted two bond fund managers as saying that the fundamental state budget problems still exist in California.

Ken Naehu, who oversees $2 billion in municipal bonds at Bel Air Investment Advisors in Los Angeles, was quoted as saying,

“There won’t be a tremendous change in perception purely because the budget has passed. The municipal market is dominated by retail investors now and those investors have been scared, have been spooked."

Paul Brennan, who oversees $12 billion in muni bonds at Nuveen Asset Management in Chicago, including $1 billion in California bonds, was quoted as saying,

"Some of the budget is being balanced from either additional debt or this potential stimulus aid from Washington, that’s a one-time shot and that doesn’t solve the structural deficit."

Currently California has the worst bond rating of any state in the nation. That means that it will have to pay higher interest rates to attract investors when it resumes selling bonds. The state has not sold any bonds since last June.

The Bloomberg article also reported that state Treasurer Bill Lockyer said that the state is considering offering bonds within six weeks.

Bonds are virtually the only source of cash for the state stem cell agency.

A Caution about Excessive Industry Coziness at CIRM

A longtime observer of the California stem cell agency is warning that the $3 billion enterprise is on the verge of becoming much too intimate with industry.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., said that a plan to create an industry biotech advisory group for CIRM is "fraught with pitfalls."

Writing on his organization's blog on Feb. 19, he said,

"Who picks the members? What would be the criteria for selection? Will the meetings be public? Will these advisors also be applying for grants?"

He noted that four members of the CIRM board of directors hold their positions because of their ties to the life sciences industry. Conducting special, public meetings with industry is okay, Simpson said. Biotech lobbyists can also take part in regular meetings of the agency.

But Simpson wrote,

"Creating an industry special interest group to whisper in the ears of CIRM executives is just wrong-headed.  What do you say to biotech companies not on the panel? Will there be an advisory group from academia, another from patient advocates and another advisory group from the public?

"But that's exactly what the ICOC (the CIRM board) and its committees are supposed to do with their public meetings.  Selecting some industry representatives and giving them special treatment and access to CIRM's leadership is simply wrong."

The 'House of Cards' and a $400 Million Fund-Raising Drive

Borrowing $400 million for stem cell research is no small task, but one that CIRM has chosen for itself.

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., today raised questions about the nature of the effort, given the nation's shaky economy and the "house of cards" that is the budget deal approved today in Sacramento.

Here is what Simpson said in an email:

"It strikes me that despite the budget deal, it still may be a long time before the state can get into the bond market.

"Key parts of the deal have to go before the voters in a special election in May. I don't see how you can sell bonds until the outcome of the election is known.

"And, it seems to me, the chances are excellent that the voters just might turn the proposal down throwing everything back to square one.

"I don't know what it does to private placement, but it seems to me that the just-passed budget may be a house of cards that collapses.

"I like to see myself is an optimist -- maybe I'm influenced by how much my own assets have tanked -- but I think it will be an uphill struggle to place $200 million before September when CIRM's cash runs out."

Who is on the Hook for $400 Million in Stem Cell Science?

An anonymous reader has posted a question on the "California budget mess" item, asking about who will pay back the $400 million in bonds that CIRM is seeking to sell privately to support its operations. We suspect some other readers may have the same question, so we are responding here.

But first, let's rephrase the question in more straight forward language: Who is going to pay the $400 million that the state stem cell agency is seeking to borrow privately?

The answer is the state of California and its taxpayers. The bonds are, in fact, loans to the state and become the "general obligation" of the state. They are no different than general obligation bonds that are sold by the state to execute other projects. The bonds do not rely on CIRM to generate revenue to pay them off. The state cannot declare bankruptcy, according to a briefing for CIRM directors last month. Thus investors would seem assured of earning a return at some point. Income from the bonds is also exempt from California taxes but not federal taxes, making them favored investments for California-connected persons and enterprises.

The state has "placed" only $250 million of the $3 billion in bonds authorized to be sold on behalf of CIRM. That initial round of borrowing was the first time ever that general obligation bonds have been used to "finance the development of intellectual capital," according to the state treasurer's office. Generally bonds are used to build roads, hospitals, housing and other "hard" assets.

Here is a rundown from the state treasurer's office on California bonds that should answer nearly all questions about the nature of the devices.

California Passes Budget, Issuance of Stem Cell Bonds Still Distant

In the predawn hours today in Sacramento, California lawmakers passed a budget aimed at dealing with a $42 billion state deficit, but the spigot that feeds CIRM remains firmly closed.

Nonetheless, the action does assist with CIRM's own plans to bootstrap itself out of its cash crunch.

The state legislature has sent the spending proposal to the governor, who is expected to sign it in the next few days. The action sets the stage for possible issuance of state bonds, the funding mechanism for the California stem cell agency, which is facing a major financial shortfall.

State Treasurer Bill Lockyer is evaluating the new state budget to determine whether it enables the state to return to the bond market and under what conditions. However, even if bonds are sold in the next month or so, bonds for CIRM are not at the top of the $53 billion list.

In response to a query from the California Stem Cell Report, Tom Dresslar, a spokesman for Lockyer, said,

"We need to analyze the product(the budget) and get a firm handle on cash flow before we can say anything about how the budget will affect our ability to return to the bond market."

However, passage of the budget should help with the CIRM plan to sell privately $400 million in state bonds to provide funding for CIRM. The legislative action removes significant uncertainty and should help counter possible objections from potential buyers.

The treasurer's office has also assisted indirectly by leading the way on the private placement of state bonds, which has never been done in state history. Lockyer's office has already cut a deal with the San Francisco Bay Area Toll Authority to buy $200 million in state bonds. That means CIRM will not be in the unenviable position of being the first out of the trenches with a private sale and can point instead to a precedent.

Here are links to some budget stories: Wall Street Journal, Sacramento Bee, Los Angeles Times, San Francisco Chronicle and New York Times.

Chapter Two of 'Waiting for Obama' -- The Vagaries of Vagueness

President Obama's delay in announcing changes in federal restrictions on human embryonic stem cell research today triggered another article on the resulting nervousness in stem cell circles.

This one came in the Washington Post. Written by Rob Stein, the piece, intended for publication Thursday, said,

"...{T)he delay and the vague language (from the administration) are making proponents nervous. Has Obama simply been too preoccupied with the economic crisis to focus on the issue? Is he hesitant to wade into one of the flashpoints of the culture wars? Could he even be considering a moderate move as part of his broad strategy of seeking the middle ground on even the most contentious issues?

"'The word the president is 'considering' it is too vague a word for me," (Amy Comstock Rick (of the Coalition for the Advancement of Medical Research) said. 'I don't know entirely what that means. If it means he's just working out the details that's great. But if 'considering' means 'reconsidering' we would be very upset.'"

Stein said the White House has reassured the worriers that something will happen soon. He also quoted Story Landis(see photo), head of the NIH stem cell task force, as saying,

"We are assuming that what we will be asked to do is develop guidelines for stem cell lines derived from embryos produced for reproductive purposes in excess of need."

But Stein added,

"Proponents of the research hope the executive order and resulting NIH guidelines would be more open-ended than that, allowing research on stem cells derived in other ways."

Landis' advice to researchers? If you are smart, start writing your grant now.

(Editor's note: Chapter One of "Waiting for Obama" can be found here.)

Fresh Comments

Ty Tyler has published a comment on the "waiting for Obama" item.

David Granovsky has posted a comment on the "CIRM touts" item.

CIRM Touts Its Financial Outlook

CIRM has officially but quietly announced that it hopes to raise $400 million through 2010 by selling California state bonds privately, a task never before achieved in state history.

The information on the private placement goal was posted Friday on the CIRM web site with virtually no notice or fanfare. The CIRM home page, which often carries far more trivial matters, makes no reference to the item about the state of CIRM's troubled finances. The three-paragraph posting was placed near the top of the CIRM web page page entitled "Funding Opportunities" and "Current Requests for Applications."

As far as we can tell, the item is the only significant reference on the CIRM web site to the hours and hours spent by worried directors last month discussing the agency's cash woes, other than the transcript of the meeting itself.

While the agency is now about seven months away from running out of cash, the Friday item has a positive headline, "CIRM's Financial Commitments Are Secure." The language is tailored to reassure grant applicants, especially those applying for the $210 million disease team RFA that was also posted on Friday.

The financial-status posting also refers to a "CIRM program with the state treasurer" for private placement of bonds. If the program is actually in place, it is a significant advance on the situation discussed by directors just three weeks ago. Many questions were raised at the time by directors about the plan. CIRM Chairman Robert Klein, who devised the private placement effort, promised to report back to the board at its meeting March 12.

CIRM seems determined not to call public attention to its financial problems, given its handling of the matter as long ago as its December board meeting. The January meeting included a lengthy briefing on the subject, but the public had no advance notice from CIRM of the sweeping scope of the problem. Even directors seemed taken aback.

A number of the directors were concerned about the public relations message that would be delivered as a result of the briefing and the ensuing discussion. There was a decided effort at the time to put a positive spin on the news. However, while directors approved $58 million in grants, they balked at funding until they knew more about the agency's finances. Efforts were also made to reassure current recipients of CIRM grants that money would still be forthcoming.

The public relations and positioning tactics could be construed as Pollyannish. But the agency must act in a way to retain the faith of the stem cell community that it will continue to operate unimpeded by what it hopes are transitory issues. CIRM needs a positive outlook to attract the best proposals for its disease round. It also must sell a story of past accomplishment and a rosy future to potential buyers of its bonds. No one is going to invest in a sinking ship.

At the same, CIRM directors and its executives should not be misled about the realities. Waiting too long to act on other measures to deal with the cash crunch will only compound the problem.

(A side note: In an operation independent of CIRM, the state of California is expected to announce later this week that it will make its first private placement of general obligation bonds, which could help smooth the way for CIRM sales with nervous investors. If the state does, in fact, make the private sale, CIRM, which has recorded a number of firsts in its brief life, will not have the opportunity to record another.)

Here is the full text of CIRM's "secure finances" posting:

"California voters approved the sale of  $3 billion in bonds to fund the work of the California Institute for Regenerative Medicine. The State finance committee created to oversee those bonds has authorized the issuance of the full amount.  A total of $2.5 billion in authority remains in funding availability. Proceeds from sale of the bonds are constitutionally protected and can only be used to fund CIRM programs and operations.

"CIRM currently has significant cash reserves of $160 million, which can fund all existing commitments through at least September. The agency’s plans have always called for raising new capital on a cash-flow, as-needed basis. We expect the traditional bond market will open soon with resolution of California’s budget situation.  To supplement this public bond market, CIRM is working with the State treasurer’s office on a CIRM private placement of $200 million in general obligation bonds this year and $200 million again next year.  The CIRM program with the State Treasurer is designed to produce sufficient funding in 2009 and again in 2010 to maintain the pace of funding under CIRM’s proposed grant schedule.

"The Agency intends to continue the planning and review needed to maintain its mission on schedule and expects that additional bond funds will become available by the time they are needed."

Long Wait for CIRM in the California Cash Queue

How long is the line for cash in California before the state's stem cell agency might get some?

Think about $53 billion in bonds waiting to be sold. That is the amount, including CIRM-connected bonds, that has been approved but not yet brought to market. Compare that to the total of $7.35 billion in general obligation bonds sold by the state during the entire fiscal year 2007-08.

California state bonds are what pays for the grants to researchers and the operations of the stem cell research effort, which is now facing a serious cash flow problem. That's because the state has not sold bonds since last June. And it currently has $52 billion in bond indebtedness.

Once the budget mess in California is resolved, the state treasurer's office has told CIRM it will have to wait for funding until other, more pressing bond needs are met.

NY Times Examines the California Budget Mess that Ensnared CIRM

California's $42 billion fiscal fiasco, which is threatening its $3 billion stem cell research effort, today drew some major and dubious media attention.

In a piece by Jennifer Steinhauer, The New York Times reported on the shameful shenanigans in Sacramento. Ballooning deficits, intransigent lawmakers and a governor who is "free of allies or influence" were just part of her first paragraph. The budget issues are so great that CIRM's relatively picayune problems did not merit even a word, although they have raised a loud alarm in state stem cell circles.

California faces a $42 billion budget shortfall. A partial solution is now before lawmakers in Sacramento, but a handful of Republicans, who are more interested in ideology than solving problems, are blocking passage.

Steinhauer wrote that the state, in a nearly unheard of move, has lost access to much of the credit markets and that its bonds are now rated the lowest in the nation. That is the reason that the California stem cell agency is now facing a hefty financial shortfall. The agency relies on bond funding, and the state has not sold any since last June.

Steinhauer continued,

"'No other state is in the kind of crisis that California is in,' said Iris J. Lav, the deputy director of the Center on Budget and Policy Priorities, a liberal research group in Washington. The roots of California’s inability to address its budget woes are statutory and political. The state, unlike most others, requires a two-thirds majority vote in the legislature to pass budgets and tax increases. And its process for creating voter initiatives hamstrings the budget process by directing money for some programs while depriving others of cash."

It was a voter initiative that created the California stem cell agency and isolated it from control by the governor or the state legislature. Instead the ballot measure, Prop. 71, gave CIRM direct funding from state bonds. The measure initially protected CIRM but now the agency has become part of the financial collateral damage in California's budget battles.

Robert Klein, chairman of the stem cell agency, has proposed an effort to sell bonds privately to ease CIRM through its hard times. The state has never before sold bonds privately, but is reportedly ready to do that soon – but not for CIRM. The stem cell agency will have to wait in line while more pressing needs are addressed. Meantime, Klein is trying to cobble together a plan for CIRM to peddle the bonds directly to foundations in the hopes of meeting two of the foundations' needs – a solid return on their investment (probably 5 to 6 pecent) and funding worthwhile research. He is expected to report on that effort at CIRM board meeting on March 12.

Klein, who is an attorney and real estate investment banker, led the drafting effort on Prop. 71. The idea was to make the agency immune from "political" tinkering. In the process, however, he wrote into the measure the seeds of a number of problems that have surfaced since its passage in 2004. The reliance on bond funding is just one, and it now puts the agency, once fiscally well-endowed, near the end of the line for cash as California works its way out of its budget mess. And because the whole arrangement is locked into the state Constitution and state law and virtually impossible to change, CIRM's tenuous situation will continue for some time regardless of what makes good sense either scientifically or in terms of sound policy.

Concerning our earlier comment about the shenanigans in Sacramento, many folks working up there deserve some responsibility for the budget crisis. But fundamentally it is failure of leadership – particularly that of Gov. Arnold Schwarzenegger, who appears to have lost much of the clout he once had and is also unwilling to devote his remaining political and financial resources to "persuading" GOP lawmakers to vote for a budget. (He would do well to study the exercise of power by Lyndon Baines Johnson.) The state GOP legislative leadership seems to be locked into some fantasy unconnected to the realities of the California economy. Democrats also have not conducted themselves well along with the host of special pleaders lobbying in Sacramento, ranging from teachers and business interests to environmentalists and prison guards.

Science, Marco Polo and Kissing

Given that today is Saint Valentine's Day, we are indulging in an aspect of science that may not have much to do with stem cells – kissing.

Sheril Kirshenbaum of NewScientist magazine has graced the online world with a look at one of the latest theories about the origins of kissing. It comes from neuroscientist V.S. Ramachandran of UC San Diego and the Salk Institute, who has been labeled the "Marco Polo of Neuroscience."

Kirshenbaum writes that Ramachandran "points out that since our ancestors needed to find ripe fruit, they would have been attracted to the color red."

She quotes the scientist as saying,

"Red thus became an indicator of food reward. Then something called 'evolutionary co-option' happened, turning red into a general signal for attraction."

Ramachandran says that despite changes that have resulted in an upright posture for human beings, swollen lips remain attractive to males "because of an atavistic persistence of evolutionary memory for attraction to red."

Kirshenbaum notes,

"This hypothesis is supported by the fact that bonobos ( a type of great ape) share our pink lips, as well as our inclination toward kissing, face-to-face mating and oral sex - much more so than pale-lipped chimpanzees."

In a separate piece, NewScientist editorialized,

"...(T)he role of kissing remains mysterious. Perhaps it is one of those facets of human behavior that will remain forever beyond our ken - but no less delicious for that."

As far as we can determine, Ramachandran is not a recipient of a grant from the California stem cell agency. But some clever folks at CIRM might be able to conjure up a concept for an RFA that could attract his attention and advance science in this important area. Color the application red.