Thursday, April 02, 2009

Time Now for CIRM to Let Sunshine In

California Gov. Arnold Schwarzenegger today set a fine example of openness – one that should be emulated by the California stem cell agency.

His action follows by one day another sterling case of transparency – this one involving a member of the board of directors of the California stem cell agency, Philip Pizzo(on right), whose main job is running the Stanford School of Medicine.

Both men acted to maintain and bolster support for important societal institutions at a time when public confidence in our leaders has been sadly eroded.

It took a bit of a scandal -- disclosed by the Los Angeles Times -- to force the governor to make his move. But today, Californians can check out for the first time online the economic interests of the top state executives appointed by Schwarzenegger. They can also view the officials´ monthly travel expense reports. (The information is a public record, but has not been easily accessible previously.)

The governor put the material online after Michael Rothfield of the Times reported that several top members of his administration charged taxpayers thousands in airfare, hotel and meal costs with little oversight. Two members have since left.

In announcing the new online information, the governor said,
“Since taking office I have taken steps to make government more accountable and responsive to the people. By making the economic, gift and travel information of the senior members of my administration easily available online, we are taking unprecedented steps to open up our government to the people – yet another critical step toward more government transparency.”
On Wednesday, Pizzo announced that Stanford will be posting online “the medical- and research-related consulting activities for some 1,200 physicians and faculty affiliated with the medical school.”

Pizzo, dean of the medical school, said,
"Industry collaborations are critical to furthering research efforts and innovative patient care, but at the same time, concerns over these activities are eroding the public trust. I hope that steps to increase transparency will resonate with those we serve, educate and work with — and reinforce that trust."
The Stanford medical school has been in the forefront of moves to increase transparency in medical research. In 2006, Stanford physicians were barred from ”accepting biomedical industry gifts, including drug samples, anywhere on the medical center campus or at off-site clinical facilities where they practice,” the school says.

The California stem cell agency has promised the highest standards of openness and transparency. In some ways, it is quite open. But it is an agency that was constructed with huge built-conflicts. Its board of directors is dominated by folks from the institutions that have been the chief beneficiaries of CIRM´s largess. As of last October, 18 institutions with representatives on the board (past and present) had received $552 million in CIRM grants.

The political reality is that the structure of the agency is not going to change. Given that fact, it behooves CIRM to lay all its cards on the tables. At least that way, the public knows who stands to benefit from the billions CIRM is giving away at a rate of $24,000 an hour.

CIRM should make the statements of economic interests from its directors and top officials available online in easily searchable and downloadable databases along with their travel and other expenses.

The agency should also disclose the economic interests of its scientific grant reviewers. Although they make the de facto decisions on grants, the reviewers´ statements of interest are withheld from the public and the scientists who are the subject of their scrutiny. That is a situation that naturally generates suspicion, especially since their deliberations are conducted behind closed doors.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., wrote about the Stanford action on his organization´s blog. Simpson called for more disclosure from CIRM. In a comment to the California Stem Cell Report, Simpson said,

“Bob Klein (CIRM chairman) talks about transparency. He ought to do something about…. Working group members aren't required to file any public disclosure now and that is outrageous. If the governor can post monthly travel reports, so can the stem cell agency. Doing less means that claims of transparency are nothing more than empty rhetoric.”

CIRM is currently a bit strapped for cash, but the governor´s office has already done the hard work of setting up online templates for the disclosure statements. It would take little more to fill in the information.

Evidence of public´s current disenchantment with our leading institutions can be read and heard every day. CIRM can help to restore confidence by following the governor´s lead. CIRM will also help itself by acting in a way that demonstrates its responsiveness to concerns about its conduct and openness.

Comments on the California Stem Cell Report

Late last night, an anonymous comment was posted on this site that contained deeply, deeply offensive language concerning President Obama.

I removed the comments today within minutes of learning of them. I apologize for their appearance and profoundly regret their presence on this website. The comments had no place on this blog or in the discourse about the events in our country.

I also want to share with our readers the current state of the ¨comment¨ function on the California Stem Cell Report. A few years back, I began with un-moderated comments. But libelous and offensive anonymous postings appeared concerning one of the spouses in a marital dispute, who happened to be involved in the stem cell business. As a result, I began moderating comments.

Virtually all of the comments since then have been civil and within the bounds of reasonable discourse. A few amounted to spam. Moderation allowed me to prevent them from ever being posted.

A week or so ago, I removed moderation in hopes of stimulating additional commentary and dialogue. A couple of spam items surfaced and were removed. Then this latest ugly comment came in.

I believe it is an aberration and do not want to let the hate-mongers stifle public debate. So I am going to continue un-moderated comments, at least for the time being. My policy is to allow virtually all comments with the exception of offensive or obscene statements such as the one posted last night. I believe that robust criticism of this blog, its writer as well as others involved in California stem cell matters is to be encouraged. Libel and spam, of course, are not okay.

If you have any thoughts on all this, you can post them as comments by clicking on the word "comments" at the end of this item or you can send them to me privately at djensen@Californiastemcellreport.com.

Wednesday, April 01, 2009

Novocell Patents and Potential Profits

The latest developments involving Novocell, a San Diego, Ca., firm, and its stem cell patents are explored today in a piece by Terri Somers in the San Diego Union-Tribune.

She reported that the privately held firm "may have found new ways to make money from its technique for coaxing human embryonic stem cells into insulin-producing pancreatic cells." Somers recapped Novocell's patent picture and reported that the company announced on Tuesday that it "received a patent that essentially gives it control over all endoderm cells made from human embryonic stem cells."

She quoted Liz Bui, Novocell's director of intellectual property, as saying the firm hopes to collaborate with larger firms that have previously shied away from stem cell research.

Somers also noted the broad nature of the Novocell patent. She wrote:

"Many patents are for a method, or scientific process for making something, sort of like a high-tech recipe.

"The patent Novocell received is for composition, meaning it is not for how to make the endoderm cells, but the actual cells 'the product of the recipe.'"
She said that such patents have been controversial, citing the example of those held by Jamie Thomson of the University of Wisconsin. Some have argued that the patents on Thomson's work are so broad that they impede science.


Tuesday, March 31, 2009

CIRM Enters Battle Over Textbook Guidelines

Deciding what goes into the millions of textbooks used by California school children is a tedious and arcane task. But it is also one that is, at times, fought bitterly and intensely, albeit well away from the public gaze.

The California stem cell agency now seems ready to join that fray.

Reporter Ron Leuty of the San Francisco Business Times wrote this week:
"Backed by the state Board of Education — as well as powerful lawmakers — the California Institute for Regenerative Medicine is ready to reshape the state’s science curriculum and direct a rewrite of textbooks to include sections on stem cells."
Leuty said that the board, which deals with matters in grades kindergarten through 12, voted on March 11 to include stem cell science in the science curriculum.

(One might wonder whether it ever was excluded. But no matter.)

What the action does is set the stage for the state's Curriculum Commission to set guidelines for textbook publishers who peddle their wares for California pupils. Leuty also wrote that that the commission, with the help of CIRM, is charged with setting up a pilot stem cell program in high schools in 2011.

CIRM says it is all about jobs, tying education to training for work in the stem cell industry or related fields. But for others, it is about ideology and "truth." At least that's the way Katie Short of the Life Legal Defense Foundation of Napa, Ca., put it. She told Leuty,
"We would be for the truth being told."
Speaking as one who covered education for a couple of years (including the state Board of Education), we can testify that Short and like-minded folks (the intelligent design crowd) are likely to muster a strong presence as stem cell textbook guidelines are promulgated. It is not a battle for the faint of heart and may require that CIRM hire an outside consultant to be effective.

Sunday, March 29, 2009

LA Times Column Rips CIRM as Riddled with Conflicts and Sucking Up Precious Dollars

The first sentence in the article in the Los Angeles Times, California's largest circulation newspaper (1.2 million readers), says,

"In the annals of wrongheaded things done with the best intentions, the California stem cell program has always been in a category of its own."

And that's just the beginning. Next come rife conflicts of interest, spotty public disclosure, a "persistent ethical morass" and a multiplying potential for waste. Not to mention the 2004 ballot initiative that created CIRM through a political campaign of "exceptional intellectual dishonesty," led by the man who is now chairman of the $6 billion research program, Robert Klein (see photo).

The scathing piece was written by Times columnist Michael Hiltzik for Monday's edition of the Times, which says it has 1.2 million daily, generally well-educated readers. The home page of Times website, which has more than 11 million unique visitors a month, also linked to the article.

The activities of the California stem cell agency have rarely graced the pages of the Times. So CIRM is likely to be new subject to many, if not most of its readers, making it easier for a column such as Hiltzik's to have a significant, opinion-shaping impact.

Hiltzik makes his point of view abundantly clear. He writes that CIRM "threatens to suck up precious fiscal resources of a state with none to spare and is rife with conflicts of interest."

He continues,
"The institute is tangled in a persistent ethical morass. From the start, its safeguards against conflicts of interest by members of its 29-person governing board were sketchy, and provisions for vigorous debate over its goals and methods were nil."
Hiltzik says CIRM director John Reed should have been ousted from the board for attempting to overturn rejection of a grant to the organization he heads, the Burnham Institute. Hiltzik quotes figures from the California Stem Cell Report that show 18 institutions with representatives on the board (past and present) have received $552 million in CIRM grants as of last October.

Hiltzik writes,
"Lacking any truly independent members, the board is dominated by Klein and devoid of 'genuine debate,' observes UC Berkeley Law professor Kenneth Taymor, who spent months studying the body. Indeed, reading transcripts of the board's sessions, one sometimes gets the impression that the only vigorous debate among the members involves which historical figure Klein more resembles, Albert Schweitzer or Mahatma Gandhi."
Hiltzik also discusses the ongoing shift at CIRM towards product development. He quotes Arnold Kriegstein of UC San Francisco as saying he fears the move is motived by a "desire to come up with a real clinical triumph they could claim credit for. I'm concerned that in the rush to get there they may be spending a fair amount of funds on projects that are just not ready yet."

There is much more, including a defense of CIRM's strategy by its chief scientific officer Marie Csete.

Hiltzik's observations cannot be written off as the frothings of a journalistic lightweight. The author of three nonfiction books, he shared a Pulitzer Prize in 1999 for reporting on corruption in the entertainment industry. In 2004, he won a Gerald Loeb Award, one of the top national honors in financial journalism, for his columns. Earlier this month, he was a co-winner of another national business reporting prize for a Los Angeles Times series called "Shedding Risk."

It is safe to say that Hiltzik's latest column will not be warmly received by CIRM. It will add fuel to the state's Little Hoover Commission's investigation of CIRM. It will feed legislative efforts to ensure that Californians have affordable access to stem cell therapies that result from CIRM-funded research. And it will hamper both Klein's efforts to privately market state bonds to bail out CIRM and his lobbying efforts for a $10 billion federal, biotech stimulus package.

(Editor's note: What do you think about the Hiltzik column? You can make your comments by clicking on the word "comment" below. The comments are unmoderated and can be totally anonymous. Google, which houses this blog, makes it impossible to identify the authors in such a case. Or you can send your comments to djensen@californiastemcellreport.com for posting.)

Prieto Dismayed by Bee Editorial on CIRM

Francisco Prieto is a Sacramento area physician who serves on the board of directors of the California stem cell agency.

Today he took on his hometown newspaper, The Bee, in connection with its editorial on March 18 deploring the election of two vice chairmen to the board of directors.

In an op-ed piece in the newspaper, Prieto said he was surprised to see it endorsing a Republican from Southern California (Duane Roth) for any statewide position.

Prieto wrote,
"Given The Bee's more usual political inclinations, it seems odd that you would suggest one candidate is superior simply because he is sufficiently well off to decline the salary this position normally carries. No employer has the right to insist an employee work for nothing, and that certainly includes the state of California. It was outrageous to imply that the superior candidate for any position must be the one wealthy enough to forgo a salary.

"Does The Bee really believe that those Californians – most of us – who need our salaries to support our families do not have the right to participate on California boards and commissions? That is a remarkably elitist and anti-democratic point of view.

"I was taken aback by your closing lines: 'the ICOC(the CIRM board) is neither independent, nor a group of citizens …' I can understand questioning our motives and integrity – that comes with the territory. But isn't revoking our citizenship a bit harsh?"

Friday, March 27, 2009

Science Magazine on the State of CIRM

The California stem cell agency "is scaling back, rethinking its priorities and looking at how to mesh its activities with those that will soon be funded by the National Institutes of Health," according to Science magazine.

Writing
in the March 27 edition(subscription required), Constance Holden provided an overview of the current status of the beleaguered $3 billion agency. It will run out of money next fall unless it can privately market California state bonds.

Holden characterized as "bold" the bond sale effort by CIRM Chairman Robert Klein, whom she described as "perennially optimistic."

Holden also wrote that John Robson, CIRM vice president for operations, said:
"...(O)ther CIRM officials 'are not as optimistic as Bob' about finding buyers, but they should be able to carry through their modified plans if sales bring in at least $200 million. Even then, he says, grants for basic research will have to be reduced, from $60 million to $20 million, until at least the end of 2010."
Holden also discussed the $210 million disease team grant program, whose deadline for applications was Thursday.

Holden wrote:
"Some scientists worry that the emphasis on applications is coming too soon. 'I am concerned that some of this rush to the clinic is premature,' says Arnold Kriegstein of the University of California, San Francisco. 'My concern is … they’re taking risks with potentially very little gain.'"
The headline on the Science magazine article said, "CIRM Close-Hauled, Seeks Bonds to Sustain Headway."

For those not familiar with sailing terminology, "close-hauled" refers to a point of sail upwind or "to weather." It is often the most uncomfortable point of sail with the boat pounding into large waves and heeled over so far that the crew must hang on constantly.

The reference also brings to mind another saying from the world of the sea, "Gentlemen never sail to weather." Our comment: Sometimes they don't have a choice.

Wednesday, March 25, 2009

Luring CIRM Bond Buyers: What Cost to the State?

What sort of interest rates will the California stem cell agency have to offer to privately sell taxable state bonds to fill its research coffers?

They could be a bit higher than the 5.5 percent or so that CIRM Chairman Robert Klein has discussed publicly.

That's because of the juicy rates provided to investors this week on tax-exempt California general obligation bonds.

Here is what Liam Denning wrote today in the "Heard on the Street" column in the Wall Street Journal.
"California's issue was priced for success, at an effective coupon of 6.1% on its 30-year bonds. For Californians, that equates to a taxable yield of more than 9% -- a spread of more than 550 basis points over equivalent Treasurys.

"Little wonder individual investors scooped up half the issuance, helped along by a high-profile advertising campaign. But the risk-reward balance was the main driver. California may be just a single-A credit, but in muni-land that still implies ultra-low default rates and a call over the state's considerable tax-raising powers. The prospect of tens of billions of federal stimulus dollars provides further comfort -- and probably precludes the need for more formal intervention.

"Somewhat perversely, the very prospect of higher taxes to refill state coffers makes munis more attractive to individuals, particularly the growing number of retirees burned by the stock market crash."
Of course, the private sale of the bonds is a different matter than the recent bond sale. But it is not all clear that potential purchasers of CIRM bonds would be willing to accept less than what was provided this week.

Higher interest rates are not a trivial matter for the state. CIRM is generally referred to as a $3 billion agency, which refers to its bonding and funding capacity. However, during the Prop. 71 campaign, estimates of the total cost, including interest, doubled that to $6 billion. That figure assumed the use of tax-exempt bonds. Using taxable bonds could add another $700 million to the $6 billion, according to one estimate.

None of the bonds that have been issued thus far for CIRM are tax-exempt. The whole issue of what was promised during the campaign and Bob Klein's statements on tax-exempt bonds led to something of a flap a few years ago involving allegations of deceit. You can read about it here.

Whatever the cost, CIRM does not appear to have much of a choice other than to privately market the bonds. The alternatives appear to be a shut-down or severely curtailing its operations.

Tuesday, March 24, 2009

Big California Bond Sale Augurs Well For CIRM

The state of California sold a whopping $6.4 billion in bonds today, a financial move that should help to give a positive spin to efforts to sell state bonds privately to finance the state's beleaguered stem cell research agency.

California was originally scheduled to sell $4 billion in general obligation bonds, but Bloomberg News' Jeremy Cooke reported that dealers boosted the sale by 64 percent and completed it a day earlier than expected.

Individual investors snapped up $3.2 billion in bonds before they were offered to institutional investors.

Interest rates were about 0.2 percent higher than similar securities and ranged from 3.2 percent to 6.1 percent, Cooke reported.

The high interest rates made the bonds attractive but will cost the state more.

CIRM plans to use taxable state bonds, as opposed to the tax-exempt bonds that were sold today. That means they will have to offer higher interest rates than those offered today.

The stem cell agency relies on state bonds for its funding. It will run out of cash next fall unless it can successfully market bonds privately. The state has told the agency it has a backlog of needs and CIRM's are well down the list.

Stem Cell Affordability Legislation Introduced in State Senate

Legislation aimed at ensuring affordable access by Californians to therapies developed as a result of taxpayer-funded stem cell research is once again before California lawmakers.

This year's measure is SB343 by Sen. Elaine Alquist, D-San Jose, and is now before the Senate Health Committee, which she chairs. (Alquist is at left with a friend who is now in the White House.)

A somewhat different version of the bill was vetoed by Gov. Arnold Schwarzenegger last year after it was opposed by the California stem cell agency. However, last year's legislation, SB1565, won approval of both houses by enormous margins, 37-1 in the Senate and 64-7 in the Assembly.

Enormous margins are required to enact any legislation affecting CIRM because Prop. 71 specified that 70 percent approval of both houses is necessary to enact even the tiniest changes in the law, such as removing the requirement that the chair of the agency is responsible for the CIRM annual report. The unprecedented, super, supermajority requirement does not exist for any other California legislation, including enactment of a budget or imposition of taxes.

Alquist's bill has been changed somewhat from SB1565 to permit a waiver of the affordability requirement in some unusual cases. One of CIRM's objections last year was that SB1565 was inflexible.

The CIRM directors' Legislative Subcommittee will consider its position on SB343 at a meeting March 31. Teleconference locations where the public can participate include San Francisco (two sites), Healdsburg, Washington, D.C., Menlo Park, Palo Alto, Calistoga, Elk Grove and La Jolla. Specific addresses can be found on the agenda.

Also up for consideration on March 31 is SB471 by Sen. Gloria Romero, D-East Los Angeles. The measure states that all education policy makers in the state, including those involved with kindergarten through the 12th grade, should collaborate with CIRM to advance its educational initiatives. Those include an upcoming CIRM program on stem cell science and regenerative medicine.

Alquist's bill has been referred to her Health Committee. Romero's has not yet been assigned to a committee for hearing.

Klein Promoting Stem Cell Issues in Washington

This item has been removed. The Robert Klein involved in it is not connected with the California stem cell agency, we have been told.

Friday, March 20, 2009

Snippets: CIRM Bonds, Clinicial Trials and TV Coverage

California Bond Picture – The state is moving ahead to unfreeze $500 million in funds to keep bond-funded projects on track. The Pooled Money Investment Fund approved the action on Wednesday, helping to restore a partial sense of normality to the Californa bond scene, according to John Myers of KQED. That's a tiny bit of good news for CIRM and its efforts to market bonds privately. Tom Petruno of the Los Angeles Times also reported today about the sale of California tax-exempt bonds next week to individual investors with interest rates of 5 percent or so. That makes them extremely attractive to California residents, who do not have to pay federal or state taxes on the interest. However, CIRM's bonds will be taxable, which will push their rates higher, costing the state more but making them appealing investments to the enterprises that may purchase them. No mom-and-pop sales on the stem cell bonds.

CIRM Board Audiocast – The CIRM board meeting drew 165 listeners last week to its audiocast, with 121 using the web address, the stem cell agency told us. The 45 others used a phone connection. The figure compares to 108 at the highest level at the January board meeting, the first time an audiocast was available. This is a worthwhile effort by CIRM, offering much wider access to its proceedings. Normally a public audience of about one-tenth the size of the audiocast listeners actually attends CIRM board meeting. However, the audiocast did suffer last week from a lack of promotion. The notice of the audiocast needs a mention on CIRM's home page for at least several days proceeding the board meeting. And it wouldn't hurt to get the various constituent groups to let their members and other interested parties know that an audiocast is available.

Secondhand Smoke on CIRMRobert Klein, chairman of the California stem cell agency, came under heavy fire this week on the Secondhand Smoke blog by Wesley J. Smith, an author and self-professed "trouble maker." Smith said Klein's leadership was "reminiscent of the entire financial mess at the federal level in a microcosm," among other things. Also this week, The Sacramento Bee carried a less vitriolic op-ed article by Smith on stem cell issues.

TV Time – The California stem cell agency scored some significant TV time in San Francisco on Tuesday with a 2 minute and 43 second piece. The ABC station, KGO, aired the story, which was keyed to a CIRM meeting aimed telling the public more about stem research. Carolyn Johnson did the narration. Stanford's Renee Reijo Pera held forth. Unfortunately Johnson reported that research at Stanford is funded "privately" by CIRM. As we all know, CIRM is in a very public funding situation. Nonetheless, TV coverage of CIRM is rare, and the agency should be tickled with the story.


CIRM on Clinical Trials – A 20-page summary of last month's clinical trials workshop conducted by CIRM is now available online. Readers would want to couple it with the transcripts from the session of the Standards Working Group at which it was discussed. They can be found here and here. The use of somatic cells and reporting requirements for oocyte donation were also part of the meeting.

Torres-Roth Election: An Adroit Move for CIRM

Without so much as lifting a finger, Art Torres has already had a salubrious financial impact on the California stem cell agency.

Last week, Torres(at left), the leader of the state Democratic Party and a former, longtime state legislator, was elected co-vice chair of the agency. As a result, CIRM has dropped its efforts to hire an in-house legislative relations staffer. That position has a salary range that tops out at $138,800. Torres is being paid $75,000 for halftime work.

On Tuesday, we noticed that the job opening was missing from the CIRM web site. We queried Don Gibbons, chief communications officer, whether the position was filled. He responded,

"We are saving money. The position is not needed with Art here."

Dropping the recruitment effort is modestly beneficial financially now and for the foreseeable future, given the agency's financial plight. But CIRM is chronically understaffed – capped at 50 persons by a nearly immutable state law. The agency relies heavily on outside contractors for its work – a situation fraught with well-documented financial and managerial peril at any level of government.

As for the election of Torres and Duane Roth as dual vice chairs, we think it was an adroit move, one that will benefit CIRM, certainly in the short term. A potential political problem was avoided. Much-needed internal heft was added to CIRM's governmental relations efforts along with its relations with the biotech industry. Torres will also bring a long-needed, experienced voice in governmental affairs to the highest levels of CIRM.

But as in all things, the devil is in the details of execution. If Roth and Torres butt heads significantly, either sooner or later, it could be a serious diversion from CIRM's main objectives. That is not to mention whether CIRM Chairman Robert Klein, who controls what the men do, can delegate responsibility and authority effectively without micromanaging their work. That goal for Klein should be high on the evaluation priorities by the CIRM directors' Governance Subcommittee.

Earlier this week, The Sacramento Bee editorialized that the dual vice chair situation is a poor idea because it makes it harder to check Klein's broad powers. A single vice chair would be more powerful, The Bee argued. There is a certain logic to that argument. However, the vice chairs are largely Klein's creatures. He is the one who is charged with setting their agendas, although the board of directors has a role as well. Should Klein feel that either Roth or Torres are impinging on his prerogatives, we have no doubt that he will move to freeze them out.

On the other hand, Torres is a veteran political operator and will soon develop his own constituencies and alliances both within the board as well as with outside organizations and lawmakers, both in Washington and Sacramento. Roth also already has his own constituencies within the biomedical industry and on the board.

One final note on Torres and his salubrious impact: Any savings resulting from leaving vacant the governmental affairs position will be minimized by Torres' travel and other expenses, which we assume will be relatively high and involve multiple trips to the nation's capital.

Fresh Comment

Lawrence Ebert has filed a comment on the "Sharing the Weath" item. Among other things, he says,
"An issue with the 'paying for things twice' viewpoint is that the costs of 'making the invention' (the research and patenting costs) are generally DWARFED by the development/marketing costs. If someone can't get return on THOSE costs, they won't invest."

Thursday, March 19, 2009

Fresh Comment

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., has filed a comment on the "AIG Share-The-Weath." Among other things, he invokes the late Adm. Hyman Rickover in support of requiring recipients of federal research grants to share any profits that might result. And he cites Jennifer Washburn's book, "University Inc.: The Corporate Corruption of Higher Education." Simpson also wrote on the blog on his organization's web site that a change away from the old, business-first political mood "is necessary if we're to restore economic equality in this country."

Faster Posting of Comments Enabled on This Web Site

In order to encourage a dialog on this web site, we have removed the comment moderation feature from the California Stem Cell Report. Your comments will now be posted directly and automatically to the site. You can post them anonymously, but we encourage all to post using your own names.

If you run into any difficulties using the comment function or do not see your comment posted after 10 minutes or so, please let me know via email at djensen@californiastemcellreport.com. You can also send comments for posting to that email address. I will be glad to put them up. Or if you want to excoriate me privately or provide information, you can use that same email address.

Wednesday, March 18, 2009

Timing Right for Sharing the Wealth on Federal Stem Cell Research

How are those folks over at 70 Pine Street in New York City helping those at 1750 Ocean Park Boulevard in Santa Monica, Ca.?

Unknowingly, they are creating a ripe opportunity in the nation's capital to extract a piece of the stem cell action from the recipients of government largess.

The players at 70 Pine are the executives at AIG, fast supplanting Enron as the most reviled company in modern American history. The Santa Monica address houses the offices of Consumer Watchdog, a nonprofit organization that has called for sharing the profits from any federally funded stem cell or other research.

A year ago, such a pitch would have died aborning. Today, given the scandals concerning AIG and other corporate failures, the political mood has changed and will change more – all in the direction that no one in the business community will like.

Trust in American business may be at its lowest point in history among the "informed public," according to one poll. Only 38 percent say they trust business to do the right thing, down 20 percent from last year. Presumably the figure would be even lower among the general public.

In a letter to President Obama, last week, Consumer Watchdog cited the California stem cell agency as an example for the feds to emulate in terms of sharing the wealth from any therapies that result from government-funded research. Under certain circumstances, CIRM grant recipients must pony up some cash if they bring a product to market profitably. No such requirement exists for the tens of billions of dollars handed out by the NIH.

The bailout brouhaha creates a golden opportunity for Consumer Watchdog and like-minded organizations to enact share-the-wealth requirements for federal research grants. The logic is compelling. Venture capitalists demand their share of the booty when they fund individuals or businesses. Why shouldn't the government, especially in these difficult financial times.

Consumer Watchdog and its allies could even make the case for attaching such requirements to the $10 billion biotech stimulus package being pushed by CIRM Chairman Robert Klein and the powerful Podesta lobbying group.

CIRM Director Sewell Criticizes Bee Editorial

CIRM Director David Serrano Sewell today posted a comment on The Sacramento Bee web site defending the election of Art Torres as a co-chair of the agency's board.

Sewell, who last week described Torres as a personal mentor, also challenged the newspaper editorial's comments on the power wielded by CIRM Chairman Robert Klein. Sewell wrote in part,

"When will your obsession with Klein end? While it's a source of amusement for many, it's getting old. Frankly, it borders on stalking."

Sewell also said,

"Torres has spent his entire career speaking the truth to power, and that won't change. Who better to serve as a check, a career public servant or a big pharma executive? I wonder what the public thinks."

If the other comments on The Bee's editorial today are to be taken as representative of the public – and they are not – they do not think much of Torres, CIRM or the governor.

(Editor's note: An earlier version of this item carried a photo of Sewell. We have removed it as his request.)

The Bee: Dual Vice Chairs at CIRM Enhance Klein's Power

The Sacramento Bee today said the election of two vice chairs on the board of the California stem cell agency gives its chairman, Robert Klein, "more power than ever."

The Bee made the comment in an editorial that also said that the CIRM board of directors – formally and fancifully known as Independent Citizens Oversight Committee -- is far from independent.

The editorial said splitting the vice chair position between Art Torres and Duane Roth meant that it would be difficult for the vice chair to serve as a check on Klein's broad authority and power. The Bee noted,

"If the stem cell institute had a normal structure, with a strong president handling administrative duties, the selection of the institute vice chair would be less consequential."

The Bee concluded,

"It's a further demonstration that the Independent Citizens Oversight Committee is neither independent, nor a group of citizens, nor much of an overseer of $3 billion in public monies."

Early this morning, only one Bee reader had commented on the editorial. The anonymous reader said,

"What are we to expect? It is only government money and does not belong to anyone, so why not use it to feather the nest of termed out favorites of the ruling class? "

The reader appeared to be referring to a running flap in California over the appointment by the governor and others of termed-out legislators to paid positions on various state boards.

For the record, the print version of The Bee, the only daily newspaper in the state Capitol, has not carried a story on the election of Roth and Torres. A brief mention did appear on one of The Bee's blogs.

The lack of coverage probably had something to do with the paper's shrinking staff. Ten days ago, The Bee laid off 128 employees, 11 percent of its staff. Like other newspapers in both the McClatchy chain and around the country, this was only the latest. Since June, The Bee has eliminated positions for 301 men and women, 26 percent of its staff. Sixty-five jobs have been lost in the newsroom, which now numbers 190 persons.

Stanford Reports on CIRM Finances

Stanford carried a bit of a news piece today on the California stem cell agency and its financial woes.

The headline was "State stem cell institute slows its pace of funding."

Written for the Stanford News Service by Krista Conger, the article said CIRM is deferring funding on 15 training grants, including one to Stanford. Conger reported,

"The delay will give the institute the breathing room necessary to do a private placement of bonds in an effort to shore up its financial situation."

She continued,

"'It's disappointing to hear that our funding will be delayed,' said Michael Longaker, MD, deputy director of Stanford's Stem Cell Biology and Regenerative Medicine Institute and principal investigator of the CIRM-approved grant. 'However, we certainly understand that these are difficult economic times.'"

The article also touched on another round of training grants that was approved and briefly described the current financial plight of the stem cell agency.

The article seemed a bit unusual to us. Normally, in-house enterprises such as the Stanford News Service are oriented towards PR, touting the winning of grants – not their absence. However, the piece could be an outgrowth of the hard times in the traditional media, which is virtually ignoring the stem cell agency. We may see PR practitioners stepping into that information void -- one that stretches well beyond stem cell news -- to fill the gap left by the decline of newspapers. Certainly the Stanford community cannot rely on the mainstream media to report all the news that could have an impact on that university.

Tuesday, March 17, 2009

California Bond Funding: An Easing of Constraints

California state Treasurer Bill Lockyer released another bit of good news today for California enterprises beleaguered by a lack of bond funding, although the announcement would seem to have little direct impact on the state's stem cell agency.

Tom Dresslar, a spokesman for Lockyer, said the treasurer will recommend that the state's Pooled Money Investment Board approve up to $500 million in funding for various bond-funded projects whose funds have been frozen.

The move is contingent on successful completion of the $4 billion state bond sale next week.

CIRM is not likely to be in line for that money. It has been told it is likely to be well down the list of state bond-funded enterprises. While CIRM does not benefit directly from Lockyer's move, anything that helps to create what appears to be a normal financial climate in California will help CIRM's efforts to sell state bonds privately.

Lockyer said the pooled money investment fund has $6 billion in outstanding infrastructure loans that are unreimbursed. The fund is a mechanism that provides loans for projects until bonds are sold, then the bonds are used to repay the fund.

Lockyer's announcement was contained in a widely emailed statement.

CIRM Watching Upcoming Bond Sales

The folks at the California stem cell agency will be keeping a weather eye on the bond market during the next couple of weeks as both the Golden State and Wisconsin move forward with their bids to sell more than $5 billion in bonds.

The agency depends on California state bonds for its operations and grants. And California has not sold any bonds since last June. That means that CIRM will run out of cash next fall unless it is successful in marketing about $200 million in bonds this year.

On Friday, California announced its plan to offer up $4 billion next week, the largest long term muni bond sale since October 2007, according to Bond Buyer. Fearing an overcrowded market, Wisconsin bumped up its $1.5 billion sale to this week.

CIRM Chairman Robert Klein, who came up with the plan for CIRM to privately market the bonds, will be watching both the Wisconsin and California sales for their interest rates and for the tenor of the market. Wisconsin has a better credit rating than California, which is the lowest of any state in the nation.

Placing state bonds privately is unusual, which creates uncertainty. Smooth sales this week and next would be a good sign for Klein.

He needs to move with some dispatch. More bad economic and state budget news surfaced on Friday with a forecast from the state Legislative Analyst that state revenues will fall $8 billion short of the assumptions in the budget passed last month in California.

One of those assumption is that a package of budget measures will be approved in May by voters. Initial polling shows considerable voter dissatisfaction with the state budget deal (55 percent negative). The respected Field Poll shows initial support for the measures but large numbers of undecided voters. Without passage of the measures, the state's revenue picture will turn decidedly bleak.

While Klein will be beating the bushes for bond buyers, state Treasurer Bill Lockyer has final say on sale of state bonds. Tom Dresslar, spokesman for Lockyer, told us in an email on Thursday,

"As far as I know, no final decision has been made on whether to sell the next stem cell bonds through a private placement or public offering. We may still opt for the latter. But, given the still-precarious condition of capital markets, and the CIRM's financial condition, it's nice maximize your financing options."
Late last month, we discussed the general framework of the CIRM bond sales with Dresslar. Here is what he told us,

"The Treasurer's Office will determine the structure, amount and timing of any sale. In making that determination, the office will consult with CIRM and set a course of action that best meshes the interests of CIRM and taxpayers. We have told CIRM we'll consider the private placement route, as long as they can find suitable investors.

"CIRM has the same ability to obtain loans from the Pooled Money Investment Account as any other GO (general obligation) bond program. The PMIA's governing board will meet soon to make decisions on when and to what extent it will thaw the freeze on PMIA loans imposed last Dec. 17. Assuming the freeze is lifted, CIRM could apply for loans along with all other GO bond programs."

Bernie Siegel Appearances in California

The peripatetic head of the Genetics Policy Institute in Florida , Bernard Siegel, will be visiting and speaking in San Francisco on Wednesday on the "stem cell consumer movement in the Obama era" at the Commonwealth Club.

In addition to his noon talk, Siegel will also be speaking in Palo Alto at the Smart Life Forum on Thursday at 7 p.m.

Siegel's comments are increasingly popping up in the media on stem cell issues nationally. Specific locations and more details can be found by clicking on the names of the organizations.

Monday, March 16, 2009

A Diversion: Rosemary, Garlic and Sourdough

Consider this a shameless, family, promotion posting.

If any of you folks are on the Gulf Coast of Mississippi, check out the Serious Bread at a little spot in Bay St. Louis.

Megan Jordan of the Velveteen Mind web site recently wrote that "the Serious Bread company, housed in the back of the Mockingbird Cafe, makes a mean rosemary garlic sourdough."

Serious Bread is an enterprise started by my brother, Alan Jensen, after Hurricane Katrina scored a direct hit on Bay St. Louis, a tiny community right on the beach, where he has lived for years.

You can find on the Mockingbird site a little essay by him on bread making and how a former oceanographer is now digging into poolish and biga.

Consumer Watchdog: New Role Needed for CIRM

In an article that was eclipsed last week by the vice chair and other affairs at the CIRM board meeting, one longtime observer of the California stem cell scene says the agency needs to step back, hand over the reins to the federal government and redefine its role.

John M. SimpsonI(see photo), stem cell project director for Consumer Watchdog of Santa Monica, Ca., made the comments in an op-ed piece March 12 in The Sacramento Bee.

He wrote,

"The California program has yet to produce cures; I believe it ultimately will.

"But the new active federal role demands a new CIRM approach to maximize the scientific benefits of its grants. What's needed is a close partnership with the federal National Institutes of Health, in which the state's institute is the junior partner. And CIRM needs to emphasize science, not hype. For its part, the NIH must acknowledge CIRM's contributions while the federal agency was largely out of the picture."

Simpson continued,

"Even if a few large egos are bruised, the challenge facing the state's institute is to relinquish leadership to the feds and figure out how to augment and complement the NIH efforts. There needs to be close collaboration between each organization's scientists.

"NIH emphasizes basic research. CIRM could emphasize funding later-stage translational, preclinical or even early-stage clinical trials. Federal law still prohibits using federal funds to derive new stem cell lines from embryos, though experiments can be funded once the cells lines are established. That is another opportunity for CIRM. The point is that the agency must determine where it adds the most value and concentrate efforts there."

Not all the readers of the Simpson piece agreed. One anonymous reader commented on The Bee website,

"This article is just more hype to try and divert state money from schools, hospitals, etc. and pour it into a 'rat hole' that has failed to produce anything of value."

The reader also wrote,

"Why doesn't the Bee report on the financial problems facing CIRM and it's failure to be able to fund grants they have already 'awarded.'. Where are the stories about CIRM's pending funding shortfall's The taxpayers need the facts in order to judge this mess. The best CIRM can deliver is paying its own executives and Washington lobbyists! "

Sunday, March 15, 2009

The Alan and Arnold Show

CIRM President Alan Trounson sat in for California Gov. Arnold Schwarzenegger on Saturday. The occasion was the governor's weekly radio show.

The topic was "células madres embrionarias" or human embryonic stem cells. Not that the man from down under spoke in Spanish. The governor's office translated the 2-minute, 49-second talk into a 3-minute, 29-second version that can be found on his web site.. The change in length does not mean the content changed. A rule of thumb in print is that Spanish takes roughly 10 percent more space than an English version of an article.

Both a print and audio version of the talk can be found on the governor's web site. Trounson did not attempt the Spanish version. His English already carries an Australian accent. Rather the talk began with a few words from Trounson in English followed by a Spanish audio version voiced by an unnamed translator.

In his talk, Trounson used President Obama's announcement last Monday to expound on the benefits of stem cell reasearch. He said,

"Nunca más reprimiremos a nuestros científicos y empresarios."

In other words,

"We will no longer hold back our scientists and entrepreneurs."
Or, in our Spanish to English translation,

"Never more will we stifle our scientists and entrepreneurs."

But no matter. Bien dicho, profe Trounson.



Friday, March 13, 2009

CIRM Director Sheehy Decries Unfortunate Lack of Information

CIRM Director Jeff Sheehy, a patient advocate representative on the stem cell agency's board and a communications officer at UC San Francisco, sent along this note regarding our posting of the funding priorities presentation used at Thursday's board meeting.
"Thank you for posting this doc. I'm glad you have it up so the public can see it. I still don't have a copy, though I requested one at the meeting. And, I cannot understand why this doc was not provided to ICOC members and the public prior to the meeting since the Chair had a copy of the Power Point slides that he alone used to follow the presentation.

"In this troubling budget environment, it is extremely unfortunate that information is either withheld from the Board or provided in such a way that the Board is in a position of having to make decisions without all of the information or without adequate time to digest and consider the information presented."


Bad Link Advisory

We fixed a couple of bad links on the "CIRM PR" item and this "comment" notice. If you missed them the first time, you can find them now.





Torres-Roth Election Attracts Media Attention

The board of the California stem cell agency today received more than its usual amount of news coverage as the result of the election of Art Torres and Duane Roth as vice chairs of the board of directors.

The reason for the attention is Art Torres. He is well known to the news media because of his lifelong career in politics. If the vice chair race had involved Duane Roth and Marcy Feit(another CIRM director), the election of a vice chair would have been barely noticed.

Most of the stories focused almost entirely on Torres and Roth. A notable and important exception was the piece on one of the websites of the influential magazine Nature.

Erika Check Hayden
reported on the election and much more from the meeting. Her story began:
"The California Institute for Regenerative Medicine has sharpened the agency’s focus on translating stem cell-based treatments into treatments, in the wake of President Barack Obama’s decision to loosen restrictions on federal funding for human embryonic stem cell research."
She touched on the funding crisis at the agency and its priorities, along with the struggle between basic science and translational research. She also had material from another CIRM meeting on March 11,
"'This push of getting out there to the clinic has some risks,' warned Arnold Kriegstein of the University of California San Francisco at the meeting. 'There’s a risk that little will be learned at great cost' if patients are harmed in poorly designed early clinical trials, Kriegstein said.

"And Warner Greene of UCSF’s Gladstone Institute of Virology and Immunology cautioned against 'turning over the reins' of basic science to the NIH: 'It’s foolish to expect now that the disease teams will succeed,' he said."
Terri Somers of the San Diego Union-Tribune wrote about the vice chair election. (Duane Roth is from the San Diego area.) Somers called the election "job sharing." She had this quote from CIRM director Francisco Prieto, a Sacramento physician, who spoke about compensation for the vice chairs,
"I believe that everyone should be compensated appropriately and fairly for the work they are going to do.In the context of the board and a state agency, to demand something like that excludes participation from anyone who isn't independently wealthy or cannot depend on outside income, which is a substantial portion of the population that needs to be represented here and everywhere else."
Torres was provided a $75,000 salary for halftime work. Roth has declined a salary.

The Los Angeles Times rarely covers the California stem cell agency, but again the draw was Torres in a story by Eric Bailey.

Other stories and writers included: Ron Leuty, San Francisco Business Times; Shane Goldmacher, Sacramento Bee's Capitol Alert; Juha-Pekka Tikka, Xconomy.com, and The Associated Press.

Fresh Comment

"Anonymous" has posted a comment on the "CIRM PR" item, saying that he or she has added this blog to their news reader after seeing our piece on FierceBiotech.

Thursday, March 12, 2009

CIRM Funding Priorities Presentation

Here is the CIRM presentation today on the agency's funding priorities. The document was provided courtesy of CIRM and its communications chief, Don Gibbons. The document is available via Scribd.
Priorities(at Rev IV) 2009PC

CIRM PR on Today's Meeting

Here is a link to the CIRM news release on today's board meeting. It includes a list of the institutions receiving the training grants with links to the reviews of their proposals.

CIRM Meeting Over, More News Coming

The board of directors of the California stem cell has adjourned its meeting. We will more news coming up shortly dealing with funding priorities.

Clinic vs. Basic Research: CIRM Funding Priorities

This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

The California stem cell agency today set a goal of raising roughly $240 million by privately selling state bonds over the next two years, preserving both its touted efforts to push development of therapies in the clinic and basic biological research.

CIRM Chairman Robert Klein told the board that one of those therapeutic efforts, a $210 million disease team program, is a critical piece in marketing the bonds and is unique to the agency. Without it, he said raising the funds not only will be more difficult but would turn the agency's back on its main mission.

Funding priorities came up today during the CIRM board meeting in Sacramento as a result of the financial plight of the agency, which will run out of cash next fall unless it sells bonds, virtually the only source of funding for the program.

Klein wrote the measure that created CIRM in such a fashion that it puts the agency outside the normal budget allocation processes involving the legislature and the governor.

Directors debated the virtues of funding grants for basic biology versus higher profile enterprises aimed at developing potential therapies at a more advanced stage of research.

Marie Csete(see photo), chief scientific officer for CIRM, told the board that scientists at recent hearings on CIRM's strategic plan were emphatic in stressing the importance of basic research, whose grant round sizes have already been cut.

Director Jeff Sheehy, a communications officer at UC San Francisco and a patient advocate representative, said the disease team project is already a year behind schedule. He said,
"We do not want to hamstring the disease team."
Requests for preliminary applications in that round have already gone out. It is scheduled to be awarded in September or October.

The goal set by the board of directors is just that. Klein will come back in late April with more information on his efforts to sell the bonds. The budget and funding priorities are expected to be reviewed again then.

CIRM Gives Go-Ahead on $17.5 Million Training Program, Funding Deferred on $41 Million Round

This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

Directors of the financially troubled California stem cell agency today approved funding for $17.5 million in training grants for the state's community and state colleges, but delayed funding for 12 months a more advanced, $41 million training effort.

The vote followed recommendations from CIRM staff that reflected the fact that the agency will run out of cash this fall unless it can privately market state bonds, which are virtually its only source of funding.

The two rounds of training grants were approved in January but the board deferred decisions on payment timing until it had a better grasp of the agency's financial situation. The board stipulated that recipients in the $41 million round could go ahead with their programs this year and could be reimbursed later.

The motion to fund the community/state college grants was approved 9-0 and the training grants received a 8-2 go-ahead. Twenty-nine persons sit on the CIRM board, but most of them could not vote on the grants because of conflicts of interest. The conflicts also barred them taking part in the discussion.

The staff recommendation for funding the $17.5 million program was justified because the schools do not have access to other funding. Timing is also critical since the programs need to be set up soon so they are ready for the next school year.

Rollins Richmond(see photo), president of Humboldt State University, told the board,
"To back away now would place CIRM and this whole program in question."


Board members expressed confusion during the discussion of the funding issues concerning what grantees were being told about the status of funding from CIRM. CIRM President Alan Trounson said that grantees are being informed that their cash is "subject to funds being available." CIRM Chairman Robert Klein summarized the agency's position by saying, "This is a contract. The question is timing."

Klein has repeatedly emphasized that the grants are legally enforceable contracts.

Roth and Torres Chosen as Vice Chairs of CIRM


This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

The board of the California stem cell agency today unanimously elected two vice chairpersons – Art Torres, who is the head of the state Democratic Party, and Duane Roth, who has biomedical industry connections.

The board also voted to approve a $75,000, halftime salary for Torres(photo on left). Roth(on right) is a current member of the board of directors and is rejecting a salary. He receives $112 a day for CIRM meetings and $14 an hour for meeting preparation.

John M. Simpson
, stem cell project director for Consumer Watchdog of Santa Monica, Ca., suggested the salary should be $90,000 although he has been critical of much higher salaries at the agency. However, Bob Klein, chairman of the agency, indicated that the vice chair deal had already been worked out. The implication of Klein's remark was that changing the terms at this point could make things come unglued.

The vote came after several board members noted that the men bring different, high level skills that will enhance what CIRM is attempting to do.

Director Sherry Lansing, former head of a Hollywood film studio, said the agency had a "high class problem" when the two men were nominated. She electing both will total more than two – more like five.

Lansing is co-chair of the CIRM Governance Subcommittee. She and her co-chair, Claire Pomeroy, dean of the UC Davis School of Medicine, were the key players in putting together the dual vice chair plan.

CIRM Going With Taxable Bonds on its Private Sales Plan

This item is part of the continuing coverage today of the board meeting of the California stem cell agency based on its audiocast.

The California stem cell agency is planning to offer taxable state bonds, as opposed to tax exempt instruments, in its effort to shore up its critical financial situation and avoid running out of cash next fall.

Normally the state issues tax exempt general obligation bonds, which would carry lower interest rates than taxable bonds. The interest is a cost to the state.

However, CIRM Chairman Robert Klein said that he did not believe that the state would lose out financially because of the use of taxable bonds. He said CIRM will be dealing with individual purchasers as opposed to a broader market. He said the bonds will also meet program needs of potential purchasers such as charitable foundations.

In fact, Klein said, "We may well have less than a market rate interest."

He estimated that the bonds would have an interest rate of 5 to 5.5 percent, a figure that is attractive under current market conditions. He also said that the bonds could be repackaged in a few years, taking out the tax exempt projects and reissuing bonds for them separately.

Klein said that "going taxable saves us time" and avoids possible legal challenges, plus they can be sold to a larger range of customers.

Klein's statements on the use of taxable bonds came in response to a question from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca.

Simpson also asked about the size of the legal fees involved in the sale of the bonds for CIRM. His question came after Klein said that CIRM's efforts have involved a goodly number of lawyers from other state agencies as well as CIRM and will continue to do so.

Klein said he plans to have a workup of costs associated with the private placement plan ready for the April meeting of the board. He said it is hard to estimate because the private placement plan is "unprecedented" in "our lifetimes."
Klein is a lawyer, but said he does not practice law and has no financial interest in any law firms.

In other matters, Klein acknowledged the presence of Art Torres at the Sacramento meeting. Torres is one of the candidates for the vice chair's job. Duane Roth, a current board member, is the other candidate.

The board is now in executive session.

Wednesday, March 11, 2009

Listening in on the CIRM Cash Woes, Vice Chair Election

Here is the latest information from the California stem cell agency on its audiocast Thursday of its board meeting during which its financial situation will be reviewed and vice chairs will be elected.

To hear the audiocast by telephone, dial (866) 254-5934 with an access code of 991416.

To hear it on the Internet, use this URL: http://65.197.1.15/att/confcast
Enter conference ID # 991416 then click go. No password is needed.

Do not use a period after the end of the URL

The meeting is scheduled to begin at 8:30 a.m. PDT but usually starts late, so you may not hear anything immediately unless ATT has made arrangements for some sort of recorded message.

The audiocast does not provide for public participation. But public participation is possible at remote teleconference locations at the City of Hope in Duarte, UCLA and the office of Jonathan Shestack in Los Angeles. Another location is at Toyon Farm in Napa, a horse training operation and vineyard owned by Camille and Ed Penhoet, who was the last vice chairman of CIRM and who remains on the board. Specific addresses are on the agenda.

Zach Hall on Monday Morning at the White House

Zach Hall, the first president of the California stem cell agency and now a director of the New York Stem Cell Foundation, attended the ceremonies at the White House on Monday. Here is his account of the event and some of its implications. Our thanks to Hall (pictured at left) for providing the article.

----

On a soft spring morning, a distinguished and festive group gathered at the East Entrance to the White House. It was a gathering of the tribe of embryonic stem cell research supporters – scientists, Washington officials, patients, and patient advocates, many of whom had been working for years for the day when the Presidential restrictions on stem cell research would be lifted. As we waited, we greeted colleagues, shared our excitement about the event, and began the first round of picture-taking. California was well-represented, with stem cell scientists Irv Weissman and Renee Reijo-Pera from Stanford; Bob Klein, Chairman of CIRM and author of Proposition 71; and CEO Tom Okarma from Geron. Leading stem cell scientists Jamie Thomson from Wisconsin, Shinya Yamanaka from the Gladstone Institute and Japan, John Gearhart from Pennsylvania and George Daley from Harvard were there, as were several Nobel Prize winners (Mike Bishop from UCSF, Steven Chu, the new Secretary of Energy, Robert Horvitz, Eric Kandel, Harold Varmus, Peter Agre) and other scientific notables (Bruce Alberts, Eric Lander, Francis Collins). Among the California patient advocates were long-time stem cell advocates, Roman Reed and his parents, Gloria and Don, and Katie Hood of the Michael J. Fox Foundation. A number of those present (Alta Charo, Clive Svenson, John Wagner, Janet Rowland) are well-known to CIRM as members of its Working Groups.

After passing through security, we entered the White House and, after a brief wait, streamed into the East Room where we were joined by a Congressional delegation including Speaker Nancy Pelosi, Senator Diane Feinstein and Representative Henry Waxman from California, Senators Tom Harkin and Orrin Hatch, and Representatives Mike Castle and Diana DeGette. One entire wall was packed with TV cameramen, journalists and photographers, whose presence was made evident throughout the event by the constant chorus of camera clicks.

The ceremony began with the entry of seven distinguished scientists, Nobelists and others, who would stand behind President Obama as he signed the Executive Order for embryonic stem cell research and the Memorandum on scientific integrity, their presence a clear signal of the importance of science to his administration.

The President entered, bounding onto the stage to a prolonged standing ovation. His first words were: “Well, I’m excited, too.” His speech was firm, clear and thoughtful, with the eloquence that we have come to expect from him. He was enthusiastic, but appropriately cautious about the promise of stem cell research, recognizing that “there is no finish line in the work of science.” He acknowledged and expressed respect for those who oppose the research, but cited the strong majority of Americans who believe the research should go forward. President Obama then adroitly tied the reversal of the presidential restrictions on human embryonic stem cell research to his effort to restore scientific integrity to government, to listen to scientists even when (“especially when,” as he added) it is inconvenient, and to “make scientific decisions based on facts, not ideology.” Needless to say, these words were warmly received by those present. The President ended with a tribute to Christopher and Dana Reeve and to the many people who have worked tirelessly on behalf of embryonic stem cell research.

The President then moved to the desk and signed the documents using multiple pens, as is the custom. “I’ve learned to extend my signature,” he said. After shaking the hands of those near the front (I was delighted to be one of them), the President left. Still excited and savoring the moment, the group lingered, reluctant to leave, until White House attendants pointed us to the door.

The President’s remarks, as well as the stem cell document itself, contained several small surprises. The general expectation among the stem cell community was that the Executive Order would permit federal funding of research on stem cell lines as long as they were made from surplus IVF embryos using money from private or state sources. The Executive Order, however, makes no specific mention of what can and cannot be funded, but directs the NIH to provide guidance on that point within 120 days, in light of “widely recognized guidelines.” This leaves open the possibility that the NIH could fund research on embryonic stem cell lines made by other means, including somatic cell nuclear transfer, as long as federal money was not used to make the lines. The use of federal funds to actually make stem cell lines is, in any case, illegal under the Dickey-Wicker amendment which prohibits any research that results in harm or destruction of a human embryo.

The second issue concerns whether or not legislation is desirable. The White House had indicated previously that this was a matter for the Congress to decide, but in his speech he suggested that his former colleagues “still have plenty of work to do.” Presumably this is encouragement to pass a new version of the Castle-DeGette bill, which allows federal funding for new lines made from IVF embryos, but might be taken as a reference to the Dickey-Wicker amendment. A legislative battle over Dickey-Wicker would be much more difficult and more polarizing than a revised Castle-DeGette bill.

In the end, one can only admire the President’s eagerness to engage the scientific community in solving the many problems that the nation faces, the use of stem cells among them. To be there as a scientist, among so many distinguished colleagues and supporters of biomedical research, and to see the President demonstrate his commitment to our shared enterprise, both in word and deed, was truly inspiring. I felt privileged to be at the White House on this historic occasion.

Fresh Comment

“David” has posted a fresh comment on the “Dual Vice Chairs” item, pointing out that other state constitutional officers nominated Art Torres for vice chair of CIRM in addition to state Treasurer Bill Lockyer.

Audiocast Available for CIRM Board Session Thursday

Here is a reminder that Thursday's CIRM board meeting can be heard by dialing in 866-254-5934 or using this Internet address – http://65.197.1.15/att/confcast The access code is 991416. The audiocasts do not provide for participation, however.

The public can hear AND participate in the Sacramento meeting at teleconference locations in Southern California, including the City of Hope, the Salk Institute and two in Los Angeles, one at UCLA and one at the office of CIRM director Jonathan Shestack. Specific addresses can be found on the agenda.

Dual Vice Chairs Coming Up for CIRM -- One From the World of Politics, One From Business

With less than 24 hours remaining before Thursday's meeting of the CIRM board of directors, the agency has begun unveiling a plan aimed at keeping two big dogs of California politics quite happy.

The matter involves the election of a vice chairperson for the CIRM board as well as the wishes of Republican Gov. Arnold Schwarzenegger and Democratic State Treasurer Bill Lockyer. While the scheme may satisfy those two, it was called “ridiculous” by one longtime CIRM observer.

The governor has nominated Duane Roth, a current member of the CIRM board of directors and an executive with close ties to the biomedical industry, for the vice chair slot. Lockyer has nominated state Democratic Party Chairman Art Torres, a friend and former state legislator.

The governor has been a good ally for CIRM and loaned it $150 million in state funds a few years ago during the agency's first financial crunch. Lockyer controls the issuance of state bonds, which are the only significant source of funds for CIRM. He is a key player in the agency's current plans to market state bonds privately.

The CIRM board is set to elect both men to vice chair positions at its meeting Thursday in Sacramento. That became clear this morning when the agency posted proposed changes in bylaws that create a “statutory” vice chair and a “bylaws” vice chair.

It appears that Torres will be elected to the statutory slot because it carries a salary, which he said he needs. Roth has declined a salary.

The CIRM board is also scheduled to reduce the salary for the vice chair from its current range of $180,000 to $332,000 a year. The agency has not yet posted information on its plan, but we believe the new range to be roughly $75,000 to $90,000. CIRM Chairman Robert Klein is paid $150,000 for his halftime position. It is not clear at this point whether Torres will be designated halftime.

In response to a query, John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, said,
“This is a ridiculous attempt to try and please both the governor and the treasurer. It’s also an insult to the candidates who were originally nominated and faced a real election when the (CIRM board) was first organized. Suppose next time there are four different candidates for chair. Do they create a 'statutory' chair and three bylaws co-chairs? I’ve got a modest proposal: Really please everyone and name 28 'bylaws' vice chairs.”
We are reserving comment on the deal at this point. But the bylaws changes were posted extremely late. They contain no explanation, context, justification or further details. The result is that the public and interested parties are effectively denied the right to comment intelligently or register their comments in the presence of the CIRM board of directors. Failure to provide details about the plan in a timely fashion is certainly a violation of the spirit of the California state Constitution, which guarantees a broadly construed right of access to information about issues before government agencies.

Fresh Comments

John M. Simpson of Consumer Watchdog has filed a comment on the “Shifting Sands” item. “Realtor in Toronto” has filed a comment on the “Obama Snippets” item.

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