With more than 3.0 million page views and more than 5,000 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency. David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.
Thursday, March 19, 2009
Fresh Comment
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Wednesday, March 18, 2009
Timing Right for Sharing the Wealth on Federal Stem Cell Research
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
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 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
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
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 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
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
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
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
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 cientÃficos 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
"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
Torres-Roth Election Attracts Media Attention
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.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,
"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."
"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
Thursday, March 12, 2009
CIRM Funding Priorities Presentation
Priorities(at Rev IV) 2009PC
CIRM PR on Today's Meeting
CIRM Meeting Over, More News Coming
Clinic vs. Basic Research: CIRM Funding Priorities
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
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
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
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
----
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
Audiocast Available for CIRM Board Session Thursday
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
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
Tuesday, March 10, 2009
The NY Times, CIRM and Shifting Sands
Written by Andrew Pollack, the piece said that President Obama's actions “could cause state governments and philanthropists to pull back on billions of dollars they have pledged for such work.”
Pollack discussed the California research effort as a case study in how the shifting sands of science are moving in one major arena.
Pollack said Obama's action has removed the original reason for the creation of CIRM. He reported as well that hard economic times have hammered foundations and the wealthy donors, now not so wealthy.
Pollack covered familiar ground for this blog's readers on CIRM's financial plight as well as its plans to privately market $400 million in state bonds so that it does not run out of money late this year.
He noted that CIRM is turning towards the biotech industry, a move that came under fire last week at a hearing on the CIRM stategic plan at the City of Hope. Its CEO, Michael Friedman, sits on the CIRM board. Pollack quoted Linda Iverson, a neuroscientist at the City of Hope, as saying at the hearing.
“To use taxpayer money essentially as venture capital money is beyond the pale.”Pollack continued,
“Alan Trounson, CIRM’s president, responded by saying Californians had approved the $3 billion effort to develop therapies, 'not just to get the work in scientific journals.'“Pollack concluded,
“In the meantime, 'a lot of people are running on fumes in their labs,' said Jeanne F. Loring, director of the Center for Regenerative Medicine at the Scripps Research Institute in San Diego.Pollack's story was measured and fair, but by raising at a national level questions about CIRM, it adds to the burden that the agency faces while it tries to sell bonds.
Even with the federal financing restrictions lifted, Dr. Loring said, “We need CIRM.”
With the exception of reports by Terri Somers at the San Diego Union-Tribune, no daily California newspaper has written in such detail about CIRM finances. It goes without saying that a total vacuum exists on television and radio.
The NY Times story may trigger some additional coverage. But given the gloomy state of the newspaper business, the tales of CIRM and its travails are likely to vanish once again into a media black hole in the near future.
Snippets from Obama Stem Cell Media Coverage
Nicholas Wade of the New York Times wrote:
“Members of Congress and advocates for fighting diseases have long spoken of human embryonic stem cell research as if it were a sure avenue to quick cures for intractable afflictions. Scientists have not publicly objected to such high-flown hopes, which have helped fuel new sources of grant money like the $3 billion initiative in California for stem cell research.Rob Stein of the Washington Post wrote about the job facing the NIH.
“In private, however, many researchers have projected much more modest goals for embryonic stem cells. Their chief interest is to derive embryonic stem cell lines from patients with specific diseases, and by tracking the cells in the test tube to develop basic knowledge about how the disease develops.
“...(M)any scientists believe that putting stem-cell-derived tissues into patients lies a long way off. Embryonic stem cells have their drawbacks. They cause tumors, and the adult cells derived from them may be rejected by the patient’s immune system. Furthermore, whatever disease process caused the patients’ tissue cells to die is likely to kill introduced cells as well. All these problems may be solvable, but so far none have been solved.”
“The task of deciding what kinds of studies will be supported now falls to the National Institutes of Health, which finds itself confronting far more extensive questions than its officials were contemplating. It has 120 days to do the job.Lynn Sweet of the Chicago Sun-Times carried, on her blog, a list of guests at the Obama ceremony. They included Zach Hall, first president of CIRM, and other Californians tied to the state's stem cell agency. The list did not include CIRM Chairman Robert Klein, but other stories indicated that he attended. The current CIRM president, Alan Trounson, was invited but did not attend.
“Among other things, officials will have to decide whether to endorse studies on cells obtained from much more contentious sources, such as embryos created specifically for research or by means of cloning techniques. “
Reporter Terri Somers of the San Diego Union-Tribune reported that Klein was at the ceremony and reported that he said the door is now open for more collaboration between California scientists and those in other states.
Somers also wrote:
“At a 'Free the Stem Cells' breakfast at the home of researcher Jeanne Loring of The Scripps Research Institute, scientists gathered to watch the event and toast Obama. Some were moved to tears, Loring said, because the president's actions validated research to which they have dedicated their careers.”
Fresh Comment
The remarks include the following, which is hard to disagree with:
“This calendar project may be an example of exactly the types of expenditures (multiplied over and over) which create the state's budget shortfall in the first place. State agencies should not spend money just because they can; government at CIRM, and at all other levels, have a responsibility to look at each expenditure with a critical eye toward whether the expense is fundamentally necessary and if so, insure the State's statutes governing the acquisition of goods and services are being complied with. CIRM is not a private enterprise, instead it should always be mindful that it is funded with real taxpayer dollars.”
Fresh Comment
Monday, March 09, 2009
Waiting for Obama, Chapter 5 -- Be Careful What You Wish For
With the feds back in the game, they may not look kindly on wildcat activities out in fringy California and elsewhere. Turf does, in fact, matter. Moreover, with Congress now back in the stem cell legislation business, to borrow from one oldtime political commentator, no one is safe.
Consider the comment from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca. He issued a call for the feds to act to ensure that taxpayers share in any profit generated by stem cell therapies developed with government funds.
In a letter to President Obama, Consumer Watchdog cited the profit-sharing model at CIRM and said,
“Celebrating the change in policy is not enough, however. It is now necessary, more than ever, to examine the regulations governing the way federal funds are distributed to researchers. A change in those rules is needed and we call on you to work with Congress to implement reform of the Bayh-Dole Act.”Businesses in California have taken issue with CIRM's profit-sharing rules, but the state agency has now broken the Bayh-Dole ice. The precedent in California will help fuel efforts to make changes in the federal law.
From Oakland, Ca., came another call for federal action that could have an impact on CIRM. Marcy Darnovsky, associate executive director of the Center for Genetics and Society, said the national government should enact enforceable rules for all stem cell research, public and private. Such rules would supersede those in California.
Jesse Reynolds, policy director of the center, said,
"We've seen what happens with inadequate regulation and oversight in the financial sector. The human biotechnology sector also needs effective public policy."The Dickey-Wicker amendment is already on the table in Congress. It could become the vehicle for a host of challenges to the established order in the biotech business.
More Than You Want to Know about CIRM's Cash Crisis
FierceBioResearcher reports that it has more than 65,000 industry email subscribers and 410,000 monthly page views.
Here are additional links on the subject of CIRM finances, which will come up at Thursday's meeting of the CIRM board.
An overview on the California Stem Cell Report of the situation including Power Point presentations by a top CIRM official.
CIRM´s only statement on its web site concerning its financial status.
An assessment of the January briefing by John M. Simpson, stem cell project director of Consumer Watchdog, a Santa Monica, Ca., nonprofit, and a longtime CIRM observer.
The CIRM transcript from the briefing.
Sunday, March 08, 2009
Waiting for Obama Chapter 4 -- Political Thorns and hESC
Written by Sheryl Gay Stolberg, the article said,
“President Obama intends to avoid the thorniest question in the debate: whether taxpayer dollars should be used to experiment on embryos themselves, two senior administration officials said Sunday.”Stolberg wrote about a legal prohibition that is generally subsumed in mainstream media reports on hESC research. She said,
“The ban, known as the Dickey-Wicker amendment, first became law in 1996, and has been renewed by Congress every year since. It specifically bans the use of tax dollars to create human embryos — a practice that is routine in private fertility clinics — or for research in which embryos are destroyed, discarded or knowingly subjected to risk of injury."Stolberg continued,
“Mr. Obama has not taken a position on the ban and does not intend to, Melody C. Barnes, his chief domestic policy adviser, said Sunday. The president believes stem cell research 'should be done in compliance with federal law,' she said, adding that Mr. Obama recognizes the divisiveness of the issue.Stolberg wrote,
“'We are committed to pursuing stem cell research quite responsibly but we recognize there are a range of beliefs on this,' Ms. Barnes said.”
“A senior House Democratic leadership aide, who was not authorized to speak publicly about the issue, said overturning the ban 'would be difficult, but not impossible,' adding, 'It’s not something that we would do right away, but it’s something that we would look at.”
Hear CIRM Board Live on its Financial Woes and Politically Charged Election of Vice Chair
The audiocast is the second for the CIRM board and provides a valuable opportunity for public and those affected by the agency's actions to hear first hand its deliberations and actions.
In addition to a briefing by CIRM Chairman Robert Klein on his efforts to peddle state bonds privately, the board is expected to choose a new vice chairman, probably two, in fact. You can find the politically charged details here involving Republican Gov. Arnold Schwarzenegger and Democratic State Treasurer Bill Lockyer.
According to the agenda, part of the vice chairman deal now involves an unspecified reduction in the salary range for the position, which currently is $180,000 to $332,000 annually.
Klein, a millionaire real estate investment banker, receives $150,000 for what the board has defined as a half-time job.
The board will also consider unspecified changes at the top of the CIRM organizational chart in connection with the new vice chairmen or whatever the designation for the posts will be.
None of the details are available on the agenda although the meeting is only three days away. Based on past performance, a strong likelihood exists that the public will be denied access to the proposals in advance of the meeting.
Also scheduled for board action are staff recommendations on research funding priorities that reflect that CIRM will run out of cash by next fall unless bonds are sold. The agency has not released anything beyond a cryptic agenda item on that matter.
Another topic before the board is the actual funding of $58 million in training grants approved in January. The board delayed delivery of the cash in light of CIRM's bleak financial situation.
Expected to be approved are additions to CIRM'S outside legal contracts that will push the total to more than $1 million for this fiscal year. The figure does not include the salaries and benefits of attorneys on staff.
John M. Simpson of Consumer Watchdog attended the directors' Governance Subcommittee meeting last week and reported that it approved a $180,000 hike (40 per cent) in the $450,000 contract with the law firm of Remcho, Johansen & Purcell of San Leandro, Ca.
It also approved a $180,000, 6-month extension on a contract with attorney Nancy Koch, Simpson said. Koch started with a $150,000 contract last April. It jumped to $245,000 sometime after Nov. 30 and now will total $425,000 by the end of September if it is not extended further, based on the Dec. 22 and March 5 outside contract reports.
No written justification for the increases was provided last week, although Simpson reported that Klein said the money was needed for legal work connected with CIRM's financial troubles and the inquiry by state's Little Hoover Commission. Koch is also supposed to help fill the gap until the new counsel to the president comes on board in July, although CIRM also has a $140,431 arrangement with the state Department of Justice.
In an email, Simpson said the additional funds were approved only after CIRM director Claire Pomeroy, dean of UC Davis School of Medicine, insisted on a written justification prior to final board action on Thursday. Klein said the justification would be forthcoming. Last year, Klein pushed through a 66 per cent hike in Remcho fees with no public, written justification.
Thursday's 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.
New Counsel to President Hired at CIRM
The name of the lawyer was not disclosed but she is scheduled to start at the beginning of July.
The job has been vacant since Tamar Pachter resigned in August and returned to the California State Department of Justice. Pachter was with CIRM only 16 months and had a salary of $225,000 with the title of CIRM general counsel.
If we were to hazard a guess, the new hire will not be earning that much. She will hold the title of counsel to the president. It appears that the general counsel position has been effectively eliminated.
CIRM is rich in legal talent and spending nearly $1.2 million this year for outside legal help.
CIRM President Alan Trounson disclosed that the new hire had been made at a meeting last week of the CIRM Governance Subcommittee, according to John M. Simpson of Consumer Watchdog, who attended the session.
Friday, March 06, 2009
Consumer Watchdog on Obama and CIRM
John M. Simpson, stem cell project director for the group, said,
"With word that President Obama intends to lift Bush era restrictions on federal funding of embryonic stem cell research, California's stem agency needs to think carefully about where to focus California taxpayers' money.
>>
"Fortunately the agency is in the process of reviewing its strategic plan. Clearly the California Institute for Regenerative Medicine should try to avoid duplicating funding efforts by the National Institutes of Health. CIRM's programs should augment those of the NIH."
Fresh Comment
CIRM Calendar Hooha Raises Transparency Issues; Agency Says Calendars Cost $23 Each
Based on the numbers provided by CIRM, that seems to mean that 1,535 calendars were printed. Earlier, CIRM said the calendars were sent free to its grant recipients and trainees to remind them "365 days a year where their funding comes from." The agency has 448 recipients and trainees, according to figures on its web site. Calendars were also sent to an unspecified number of "constituents."
In comments on our earlier item on CIRM's 2009 calendar, some readers of this blog said production of expensive, free calendars is a waste of taxpayer money.
Here is the current breakdown on the calendar cost, based on a CIRM report and information supplied by Don Gibbons, chief communications officer for the agency: Printing, $14,000; design, $10,200, and $11,110, which was part of a larger contract.
The $11,110 is a new figure and came today from Gibbons. He said it was part of a $45,000 expenditure with Abbott and Company that CIRM now says was for "image development, office art design and framing." The Abbott contract was initially identified as involving the calendar. After the California Stem Cell Report inquired about the calendar project, the description of Abbott contract was altered on the CIRM web site to remove any mention of a calendar. No footnote was provided on the PDF document to notify the public or directors that a change had been made from an earlier version.
Here is the text of what Gibbons sent earlier today concerning our original item on this subject.
"For the record, you never asked me for the cost per calendar. Instead you chose to make one of your usual worst-case projections. The portion of the Abbott contract that covered the calendar was $11,110, which made the cost per calendar $23. Also, this project began in July, long before the complete budget meltdown."More than a week ago, we asked Gibbons for the total number printed. He has not provided that number. Following his latest email today, we asked again for that information as well as the number distributed and the cost of postage.
As for our "projections," you can read them here along with our assumptions. They were based on information from CIRM, which was incomplete then and remains incomplete today.
The CIRM calendar is a minor expense in the agency's $13 million operational budget. But outside contracts are not. They now total more than $3 million, up from $2.7 million, as the result of action earlier this week. The outsourcing, which often poses major oversight issues for government agencies, is the second largest category in the budget.
How the agency describes the contracts and other budget items and responds to questions about them is basic to the agency's transparency and openness. The calendar issue is not the only one. A lobbying contract with the Nielsen, Merksamer firm in Sacramento continues to be described as "public education." There may be other fanciful descriptions, but without an examination of contracts and other documents, it is impossible to tell.
Several years ago, CIRM directors initiated the requirement for regular reports on outside contracting because they felt they were not fully informed. While creative budgeting occurs in every organization, without good information it is impossible to make good decisions.
Obviously it is nice to offer gestures of good will to "constituents" and others associated with any enterprise, but CIRM's calendar project came at an impropitious time. The project began shortly after a salary freeze at the CIRM that ran through December. As we remarked then, such freezes affect those on the lower end of the pay scale much more harshly than at the top levels. Perhaps during the holidays, CIRM management could have spread that $35,310 among employees making less than $70,000 a year. That would have been a nice gesture as well.
CIRM Identifies Obama as Cash Source for Its Troubled Lab Projects
His remarks were contained today in a piece by Ron Leuty of the San Francisco Business Times. Leuty quoted Klein as saying,
"Our grantees are perfectly situated — they’re in construction or about to go. They can clearly demonstrate that they’re going to create jobs."
Leuty wrote that CIRM intends to use its new, $240,000 Washington lobbyist, the Podesta Group, to help snag the cash. Leuty reported,
"The California Institute for Regenerative Medicine — with the help of a well-heeled Washington, D.C., lobbying firm — wants organizations like Novato’s Buck Institute for Age Research to seek some of the $1.5 billion that is earmarked in the $787 billion stimulus package for biomedical research facilities and construction."Other institutions previously identified as needing to raise more matching funds include the Sanford Stem Cell Consortium (UC San Diego, Scripps, Burnham and Salk) and UC Santa Barbara.
The $240,000 figure is new and comes from a copy of the contract requested from CIRM by the California Stem Cell Report. The total includes expenses plus $20,000 a month from Feb. 11 through Dec. 11, 2009. The contract, which does not need CIRM board approval, can be extended indefinitely by mutual agreement.
If you are interested in a copy of the contract, please send an email to djensen@californiastemcellreport.com.
Obama Watch Chapter 3: Funding Ban to be Lifted on Monday
According to reporter Rob Stein's story, the move will be announced at an event at 8 a.m. PDT. He cited an email sent out on Thursday from the White House concerning a ceremony at that time "on stem cells and restoring scientific integrity to the government process. At the event the president will sign an executive order related to stem cells."
No other significant details were disclosed.
Fresh Comment
Fresh Comment
Thursday, March 05, 2009
Fresh Comment
Fresh Comment
Wednesday, March 04, 2009
The Tale of CIRM´s 2009 Calendar
Last week, as part of the agenda for the meeting Thursday of the directors Governance Subcommittee, the agency posted one of its regular reports on outside contracting. The category is the No. 2 operational expense for the agency at $2.7 million for the 2008-09 fiscal year.
CIRM Chairman Robert Klein and President Alan Trounson take justifiable pride in keeping expenses low -- well under the cap in Proposition 71.
That was one reason I asked questions about what appeared to be $69,200 for a 2009 calendar. How many were printed, why and so forth. But by the time, we were through, it seemed that the cost for each calendar could range from anywhere well under $50 to perhaps $100 or so. And the report on the outside contracts had been altered to remove any mention of the calendar as part of a $45,000 expense, which is now described only as image development, office art design and framing
We will probably never know what the correct cost of the calendar is. Don Gibbons, CIRM´s chief communications officer, has not even responded to my 5-day-old question about how many were printed. However, he did say that they went mainly to CIRM grantees and trainees, which number 448. An unspecified amount went to “constituents.”
Here are the calendar figures that triggered the original inquiry: $14,000 calendar printing to Fong and Fong, $10,200 calendar production to Reineck and Reineck, and then the $45,000 for “calendar” work by Abbott and Company.
On Feb. 25, I asked Gibbons about what was entailed in those contracts as part of other questions dealing with the outsourcing report.
His response:
“Calendar was short hand used by the contract office for a complex series of projects that resulted in high resolution stem cell images fit for printing (quite difficult) that were re-used for several projects, including the FLICKR site, backdrops for media interviews, an exposition banner, to provide to the media, and for framing to dress up the bare walls of our office (framing included in the budget), and yes, the calendar.”On Feb. 27, I asked him:
“Re the calendars, for what year were they printed? How many were printed? Were they given away or sold? To whom? How many does CIRM still have on hand?”Gibbons replied on Friday:
“I don’t work for the CSCR (this web site). All of your diving into minutia is a huge waste of tax payer resources. They are paying me to execute much more important and informative projects. The calendars were printed in December for the 2009 calendar year. Almost all were given away already (if you think I am going to the store room to count the actual number left over your are crazy). None were sold. Primary audience was the grantees and trainees to remind them 365 days a year where their funding comes from. All the various constituents who give use their time on working groups etc. received multiple copies. Each image is accompanied by a story about the science it represents. Short versions of those stories are the captions on the Flickr site.”
An earlier version of this item incorrectly gave the total as $65,200 instead of $69,200. The difference was in the Fong printing contract, which is for $14,000 instead of $10,000.