Free Link to Gottlieb Article

Ken Taymor, executive director of the UC Berkeley Center for Law, Business and the Economy, points us to a non-subscription link to the article referenced in the item below. It can be found here: http://www.aei.org/publications/filter.all,pubID.26718/pub_detail.asp

New Drugs, Old Drugs, Openness and Cost Implications

The efficacy of magic or not-so-magic cures – particularly new ones and their costs -- came under scrutiny in a recent article in the Wall Street Journal called "The War on (Expensive) Drugs."

The opinion piece has relevance to California's grand experiment in scientific research with its promise of finding cures through embryonic stem cells. The expected costs of those cures, funded in part – perhaps a crucial part – by California taxpayers, have already generated concerns that they will not be available to many Californians.

Scott Gottlieb, physician and fellow at the American Enterprise Institute as well as a former senior official at the FDA and Medicare, wrote the WSJ article, which focuses on a Congressional proposal "to spend more than $300 million to establish a new federal 'Center for Comparative Effectiveness' to conduct government-run studies of the economic considerations that go into drug choices."

Gottlieb is critical of the processes involved in what he says are politically popular studies "that pit expensive new medicines against older, cheaper alternatives with the aim of cutting health-care spending."

But he also shines some light on the lack of transparency in science and medicine as well as methodologies that seem to be driven by desires for a certain result.

Gottlieb deals with three well-known studies that have been subject to considerable attention: The $725 million Women's Health Initiative, the $135 million Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (Allhat)and the $40 million Clinical Antipsychotic Trials in Intervention Effectiveness (Catie) trial.

Gottlieb wrote:

"Like the Women's Health Initiative, bottom-line data from Allhat and Catie were subject to parochial secrecy. Catie's complete safety data are only being released this September, almost four years after the study was completed. Moreover, the drugs involved in these studies were for conditions where one expects a great deal of individual variation in how people might respond. The studies didn't take measure of that.

"Now the government is sponsoring a poorly designed trial to test whether Avastin, a drug that is meant for injection into the veins to treat cancer, can also -- when injected directly into the eye -- treat macular degeneration, a leading cause of blindness. Never mind that Avastin's manufacturer, Genentech, developed a completely new drug called Lucentis, which is specifically designed to be injected into the eye and is better adapted to treat blindness.

"Since a single cancer infusion of Avastin contains a large volume of the drug, breaking that same dose down into the small aliquots needed for the eye injections is literally pennies on the dollar, making the government's study of it -- when it was clearly not designed for eye treatments -- a matter of cost containment. Surely if Avastin ends up harming those eyes -- a plausible consequence of this off-label, if not illegally 'compounded' use -- it won't be Uncle Sam on the hook with product liability lawyers, but Genentech.

"Not all government-funded studies have speckled histories. Many uncover significant advances. Problems arise when the government pursues studies to achieve its own economic goals, where political motivations seem to intrude on the design and conduct of the trials and bias not only how results are interpreted, but more especially, how they are reported."

Some readers wrote to the WSJ concerning Gottlieb's piece, including Bryan R. Luce and Dennis A. Revicki, both senior vice presidents at United BioSource in Maryland. They said,

"It seems to us, the solution is clear. Government-funded research and interpretation need to be fully open for critical peer review by independent and stakeholder experts from any sector (including manufacturers) at all stages of the process. Similarly, funded research by private industry would be well advised to follow suit. Then, perhaps, we would have less rancor and better supportable scientific evidence for informing clinical and public policy and the health and well being of the public would be better served."

Gottlieb is dubious of some government-funded studies. Others are equally dubious of business-funded studies that seem to overlook results that are not favorable to introduction of a new product. Meanwhile astronomical prices are charged patients to recoup drug development costs. Increasingly this mulligan stew of medicine and science and business is leaving few satisfied. Even fewer will be satisfied if the $3 billion ($6 billion including interest) investment by California taxpayers results in therapies that are out of the reach of millions who need them.

Stem Cell Media Coverage to Crow About

By many measures, the $20 million gift to UCLA this week brought major media attention to the stem cell research efforts in the Golden State.

The size of the gift by Eli Broad, the presence of Gov. Arnold Schwarzenegger and a set-up story Monday morning in the Los Angeles Times all drove the coverage. But so what? Who cares about PR, right?

But when 55 percent of the public nationally says it has little or no knowledge of stem cell research, the field still needs major help. And Monday's event was a chance to tell a positive tale – one that did not involve warnings of expensive therapies, dubious results or even research fraud.

To give you an idea of the sweep of the attention, a Google Web search on the term "UCLA stem cell million broad" generated 244,000 hits this afternoon. That compared to 487,000 for "CIRM" alone. But the institute has been around for nearly three years, and it is naturally going to generate more response. The number of hits on the UCLA/Broad story is likely to climb in coming weeks as other outlets and Web sites pick it up.

The story ran internationally and on television and radio, which are the prime sources of news for most people. Newspapers and the Internet remain a secondary source.

One observer connected to the event, who must remain nameless, provided a summary of the coverage that said the story was

"...featured Monday and Tuesday by the Associated Press, Los Angeles Daily News, City News Service, KNBC-TV, KCBS-TV, KABC-TV, KCAL 9 News, KTTV-TV, KTLA, Bloomberg News, KPCC 98.3 FM, KNX 1070 AM, KFI 640 AM, Telemundo 54, Univision, Chinese Daily News, Sing Tao Newspaper and LA Channel 18.

"Dr. Owen Witte, director of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA, was quoted in English language outlets. Stem cell researcher Luisa Iruela-Arispe, professor and vice-chairman of molecular, cellular and developmental biology, was quoted in Spanish language outlets. Stem cell researchers Yi Sun and Dr. Andy Huang are quoted in Chinese language outlets.

"The AP story also appeared in the International Herald Tribune, Houston Chronicle, San Jose Mercury News, Pravda, Press-Enterprise, Enterprise Record (CA), Contra Costa Times, Monterey County Herald, San Jose Mercury News, San Luis Obispo Tribune and the Daily Breeze.

"The Los Angeles Daily News story also appeared in the San Gabriel Valley Tribune, Whittier Daily, Pasadena Star News, Inland Valley Daily Bulletin, San Bernardino Sun and the Long Beach Press Telegram. The Los Angeles Times today ran a photo of Gov. Arnold Schwarzenegger at UCLA announcing the gift."

One story helped particularly to drive the coverage, a Los Angeles Times article on Monday morning ahead of the actual event(see item below). The piece put the gift in the broader perspective of stem cell research growth in California, declaring that the donation and others recently "position California universities at the forefront of the promising scientific field." That type of buildup helps to focus the attention of harried TV and radio assignment editors and helps to convince them to give a story major play.

The governor's office announced last Friday that a news event would occur involving the gift, but the size was not disclosed until Monday's story in the Times, which appeared to have it exclusively. Crafty media relations people sometimes provide such key information to an influential news outlet such as the Times in advance of an actual event to help drive coverage media. We do not know whether that occurred in this case, but it is probably a good bet.

Adding frosting to this stem cell cake was the use of researchers who could speak in languages other than English, which is important in a diverse state such as California, but very important as well for international coverage.

Photo Information: The photo above was found on a conservative web site, which seemed to be using it in a fashion that would trigger negative reaction from conservatives. The original source of the photo was not given. Left to right, Broad, the governor and Los Angeles Mayor Antonio Villaraigosa.

$20 Million Stem Cell Pay Day for UCLA

UCLA will receive $20 million from philanthropist Eli Broad for embryonic stem cell research, the "latest in a series of large gifts that position California universities at the forefront of the promising scientific field," the Los Angeles Times said today.

The article by Charles Ornstein noted that Broad has already given $25 million to USC. And he wrote,

"California universities have landed large donations to build new labs and begin their research. In May 2006, UC San Francisco received a $16-million donation. Two months later, UC Irvine landed a $10-million gift from Newport Beach fund manager Bill Gross and his wife, Sue. Stanford University has received gifts of $20 million and $33 million for research and construction."

Ornstein quoted Broad as saying,

"California, in my mind, will without a doubt be the leader in North American stem cell research as a result of Proposition 71 and the great research universities we have."

California Gov. Arnold Schwarzenegger will take part in the news conference at 10 a.m. today PDT announcing the gift. The news conference will be webcast live on the governor's website, www.gov.ca.gov.

California Stem Cell Companies Not Too Displeased with CIRM Rules

Sometimes directors of the $3 billion California stem cell agency worry that they are imposing too many restrictions on future grants to the biotech companies that will be the key to turning research into therapies.

Now comes a report that a number of companies "seem willing to do whatever they must to qualify for state grants." They, in fact, are not looking down their noses at the largess to be disbursed from CIRM.

Reporter Terri Somers of the San Diego Union-Tribune reported on the business response that came out of a CIRM informational meeting Friday that was designed to shape state policy on the qualifications and criteria for companies that receive stem cell grants from the state.

She wrote,

"The response yesterday to the institute's questions was a surprise to the institute staff.

"Representatives from the biotechnology industry said they only need to tweak the (intellectual property) policy to make it work for companies.

"For instance, the companies don't want to publicly disclose competitive information, such as what percentage of royalties they receive for licensing out their discoveries or the amount of their product sales.

"Industry representatives said they also are concerned about how the state defines money for research and money for goods and services. Currently, Proposition 71, the voter initiative that created the stem cell institute, requires all the research it funds to be conducted in California. Goods and services bought with state funds do not necessarily have to come from California.

"If clinical trials are defined as a 'research' expense, rather than 'goods and services,' it could be a problem, company executives said.

"For speed, efficacy and even savings, companies often conduct clinical trials worldwide in order to get quick enrollment and a diversity of participants."

The response from the companies seems strikingly different than earlier, more hostile reactions from the California Healthcare Institute, which says it represents the biomedical industry in California. However, the reaction was not too surprising to those who attended the Burrill stem cell meeting in San Francisco last spring. A CHI representative appeared on a panel with several representatives of stem cell companies, who did not echo the lobbying group's more strident position.

Somers appears to be the only reporter who covered the teleconference meeting on Friday.

Stem Cell Snippets: Drooping Support, Farmland, Goldstein's Views and CIRM Scholar

Declining Support for Stem Cell Research –- The Pew Forum for Religion and Public Life has released a public opinion poll that shows weakening support for stem cell research, dropping from 57 percent two years ago to 51 percent in August this year. It also showed that 55 percent of the public had heard little or nothing about stem cell research. The polling question involving support used the phrasing "destroying potential life." The results certainly would have been more negative if the word "potential" had been omitted. "Destroying life" is how many opponents view the issue. The "take-home" point? Support for human embryonic stem cell research is fragile and can easily be undermined by events ranging from a dubious experiment or result or perceived misconduct by those funding stem cell research.

ISSCR and Farmland –- Jesse Reynolds of the Center for Genetics and Society comments critically on the involvement of the International Society for Stem Cell Research in a land development proposal that also proposes the creation of a stem cell research nonprofit. You can read it here.

Stem Cells After Bush -- Lawrence Goldstein, director of stem cell research at the University of California at San Diego, was quoted on CNN Money.com concerning the future of federal funding for stem cell research after Bush. He said. "Personally, I think it's a mistake for the scientific community to assume anything about what the likely policy will be of a government that doesn't yet exist." He also said, "I would not build a business plan based on the assumption there will be federal funding for stem cell research." The article largely covered the perspective from business on stem cell research.

CIRM Scholar – A recent cover story in Nature magazine featured research by a CIRM scholar, Laura Elias at the University of California, San Francisco. She led a neural stem cell study that revealed a mechanism that may play a role in cancer. Elias is a neuroscience graduate student in the lab of senior author Arnold Kriegstein, director of UCSF Institute for Regeneration Medicine.

Fresh Comment

Larry Ebert has published a comment on the item below.

Stem Cell Bonds, Royalties and Campaign Promises

The upcoming sale of California state bonds for its unprecedented stem cell research effort raises anew a $700 million question along with allegations of deceit in the campaign for Prop. 71, the measure that created the Golden State program.

On the surface, the matters involve an arcane financial issue. Can California sell non-taxable bonds to finance the activities of CIRM or must they be taxable. If they are taxable (meaning the dividends are taxable to buyers), the state will have to offer a higher interest rate to purchasers. That, according to one estimate, could mean as much as $700 million in additional costs to the state.

Such additional potential costs did not surface in the 2004 campaign. At the time, interest costs to the state were reported as $3 billion, rather than as much as $3.7 billion. Those amounts would be needed to borrow the $3 billion for the grants for stem cell research.

Nearly a year after Prop. 71 passed, reporter Bernadette Tansey of the San Francisco Chronicle wrote that California stem cell chairman Robert Klein knew before the election that taxable bonds might be needed but did not disclose the matter to the public. Klein was leading the effort on behalf of Prop. 71.

What triggers the use of taxable bonds is CIRM's requirement that royalties be paid to the state if state-funded research generates a significant amount of income.

Tansey reported,

"The potential problems have to do with a complex and unsettled question: how federal tax law will apply to a novel state research venture, supported by tax-exempt bonds, that involves a state split of private profits.

"But IRS rules largely forbid the states to use tax-exempt bonds to benefit specific private enterprises rather than serving a general public good -- and to share revenue from an enterprise to the extent that the state becomes like a business partner."

The issue of taxability was nearly invisible prior to Tansey's article, which subsequently generated allegations of bait-and-switch tactics and statements that Klein had a moral responsibility to be more forthright about the matter.

Stu Leavenworth, associate editor of The Sacramento Bee, interviewed Klein following the Chronicle report. Leavenworth wrote,

"The integrity of Prop. 71 is at stake in the royalty(taxable bond) debate. During the campaign, advocates of Prop. 71 mentioned royalties repeatedly, with Klein touting it on the PBS NewsHour with Jim Lehrer. This wasn't by accident. California was in the midst of a budget crisis, so Klein needed to create the impression - no matter how tenuous - that Californians would get some direct return on their investment."

Leavenworth described the conduct during the campaign at best misleading. "At worst, it was a cynical ruse," he wrote.

We queried both CIRM and the office of state Treasurer Bill Lockyer, which issues the bonds, concerning whether future stem cell bonds would be taxable.

Dale Carlson, chief communications officer for CIRM, replied,

"Bonds have never been used before to fund research, and so we want to be certain that the Prop 71 offerings are eligible for tax-exempt status. (See, for example, the transcript of the 11/05 IP task force meeting beginning at page 19 (http://www.cirm.ca.gov/transcripts/pdf/2005/11-22-05.pdf)) The Treasurer's office assumes that they'll qualify, but will be seeking guidance from the IRS to be sure. In the meantime, this first offering will be taxable."

The response from spokesmanTom Dreassler in the treasurer's office was similar:

"We want to complete the initial sale ASAP so we can pay back the bridge financing provided by the state General Fund and private foundations. At this point, however, we do not have an IRS determination that we can sell stem cell bonds as tax-exempt. So, we will issue this initial $250 as taxable. Then we hope to get a formal determination from the IRS that establishes the extent to which we can issue tax-exempt stem cell bonds. Once we get that ruling, we can refinance the $250 million as tax-exempt, thus cutting taxpayers' costs. Our long-term intent is to sell as much as possible of the $3 billion as tax-exempt, consistent with the IRS determination."

CIRM presumably could eliminate the cost of the added interest by withdrawing requirements that royalties be paid. However, that is extremely unlikely. Meanwhile, the IRS opinion could be some time in coming.

You can find all the coverage by the California Stem Cell Report and links to the stories mentioned above, plus much, much more by searching the label "bonds" below.

UCLA to Receive Multimillion Dollar Stem Cell Gift

Don't stand under the stem cell money spigot -- especially with your mouth open. You might drown. First came the news of the pending sale of California stem cell bonds. Now comes the announcement that multimillionaire Eli Broad is going to make a whopping gift to UCLA.

So big that California Gov. Arnold Schwarzenegger is going to preside at the announcement on Monday, which will be televised live at 10 a.m. PDT on the governor's web site. The exact amount is not known, but Broad gave $25 million to UCLA's crosstown rival, USC for stem cell research, but apparently that was not enough to justify a gubernatorial presence. Of course, the governor may have just had a vacant spot in his calendar, and the amount may be less than the $25 million.

Broad also loaned $2 million to the California stem cell agency when it was strapped for funds because of lawsuits.

Broad and his wife, Edythe, were among the 50 most generous philanthropists in the country, according to a Business Week ranking in 2005. They have given close to $2 billion to various charities. Bravo to them. They help set an example that could well be emulated by others.

Whoopee! CIRM To Dive Into The Dough

Those of you of a certain age may remember the Scrooge McDuck comic books of the 1950s. He was the gazallionaire uncle of Donald Duck. The richest duck in the world, old Scrooge was fond of diving into the mounds of loose money in his vault and throwing the stuff into the air.

Come Sept. 27, California stem cell Chairman Robert Klein and company will finally be able to do that -- sort of – after the state sells $250 million in state bonds to finance the grants and operations of the California Institute for Regenerative Medicine.

According to Reuters, State Treasurer Bill Lockyer this week set the date for the sale, nearly three years after voters approved Prop. 71, which created CIRM and authorized $3 billion in bond financing. Lawsuits made the state unable to sell the bonds. After that was cleared up in May, state budget issues delayed them further.

Since 2004, CIRM has made to do with loans from the state and private philanthropists. All of those will have to be repaid, but it is unclear whether the bond money will go to that first or directly to grant recipients.

Interestingly, Reuters said the stem cell bonds will be taxable, which means that they will require a higher interest rate than the non-taxable bonds, costing the state more.

Christmas Coming Early for 25 California Scientists

Fifty-nine "young" California scientists are seeking awards from the California stem cell agency that could run as high as $3 million a year.

CIRM is scheduled to give away $85 million to 25 scientists in December, which should make a fine holiday treat.

Dale Carlson, chief communications officer for CIRM, told the California Stem Cell Report that applications came from researchers at 28 organizations. Eleven University of California and California State University campuses were represented. The California State Univesity system is separate from UC. Four private universities submitted applications. Thirteen non-profit research institutions were included.

The institute refuses to disclose both the names of individual applicants and institutions, even those that are taxpayer-funded enterprises.

The five-year faculty award program is aimed at drawing the best and brightest into stem cell research in California and not just embryonic stem cell research. Arlene Chiu, CIRM's top scientist, said,

“These grants are designed to encourage newly independent investigators to pursue bold and innovative studies across the full range of stem cell types – human and animal, embryonic and adult. We will consider providing successful applicants salary and research funding for up to five years, ensuring that they have stable, secure financial support as they begin their independent scientific careers.”

Director Says CIRM "More Effective" Than Other State Agencies

One of the directors of the California stem cell agency, David Serrano Sewell, has responded to comments critical of the agency in an Internet piece headlined "California's stem-cell management disarray."

Written by David Hamilton, the article said CIRM "is probably one of the most grueling places to work in all of biomedicine." He noted the departure of several top staffers at the agency this year.

Sewell, who is a member of the CIRM Oversight Committee, responded directly with an online comment on Hamilton's Venture Beat piece. Sewell said in part,

"I challenge you to find a state agency that has been more effective. Those grants don’t just happen, it takes hard work and lots of meetings. And, we’ve been transparent throughout the entire process. Thus, the system envisioned by Prop 71 works. I can appreciate that it’s your job to read the tea leaves and make some half baked spin, but you’re just wrong here."

Hamilton responded in part,

"I intended no denigration of the ICOC membership, but it’s a bureaucratic fact that when you have a 26-headed hydra trying to run a public agency, whoever controls the agenda and many if not most staff resources effectively directs the body’s effort — and that’s more or less what (California stem cell chairman) Bob (Klein) does."

You can read the entire exchange, including the original article, here. Scroll down to the bottom to find the comments.

Fresh Bustling in CIRM Presidential Search

The search for a new and permanent chief executive officer to direct the world's largest single source of funding for human embryonic stem cell research is generating a flurry of activity this month.

Robert Klein, chairman of the Oversight Committee for CIRM, scheduled a special teleconference meeting Sept. 14 of the full Oversight Committee at 3 p.m. and a meeting of the presidential search committee at 5 p.m. Another meeting of the search committee is scheduled for Sept. 28. (You can find the agendas and teleconference locations here.)

Topics on the agenda include compensation. Despite a salary range for the position that reaches $412,500 annually, the amount does not appear enough. The cost of housing in the San Francisco area appears to be one of the reasons. Other issues as well seem to be raising difficulties in finding a new president. (Search on the label "presidential search" to see full details.)

Similar rounds of meetings, which are conducted almost entirely behind closed doors, have occurred in the past with no result. The $3 billion agency has been operating on a lame-duck status for nine months since the former president, Zach Hall, announced his plans to retire.

Early in August, the Oversight Committee hired Richard Murphy, former head of the Salk Institute, to serve as interim president for six months.

Fresh Comment

Christine has posted a comment on the "Framing News Coverage" item.

ISSCR Backs Controversial California Effort

The prestigious International Society for Stem Cell Research has stepped into the flap over a land development proposal in Northern California, endorsing the concept of a stem cell research facility linked to the plan.

California stem cell Chairman Robert Klein, who backs the proposal, said in an interview that it was the first time the society has taken such an action. The group represents 2,500 scientists and others in 47 countries.

In a July letter to Yolo County officials, George Daley, president of the ISSCR, said,

"There is a severe shortage of funds for bridging the gap between academic discovery research and industry-sponsored clinical development. This gap of funding is a harsh place where small firms struggling to bring regenerative medicine to patients receive very little support from government and/or private investors. The need for philanthropic support of medical research has never been more urgently needed than today. The substantial gift offered by the Tsakopoulos Family would create a Translational Medicine Development Fund to bridge the gap between basic research and tangible potential therapies and/or cures for seventy or more chronic diseases and injuries within the field of regenerative medicine.

"We also endorse this unique concept because it will bring international institutions together and create a critical mass of scientific research that will allow collaboration and progress in a way that has never been seen before. This exciting proposal would create a world class model for scientific research and collaboration that is the first of its kind.

"We strongly encourage you to study this concept as a part of a general plan to bring economic development to your county."

Klein and Angelo Tsakopolous, a Sacramento area land developer, are lobbying for a proposed 2,800-acre land deal near the capital that would also create a stem cell research center with a projected endowment of $200 million. Earlier this spring, Klein's private lobbying organization received a $125,000 contribution from Tsakopolous' company. Klein would head the research center.

Yolo County's elected supervisors shelved the plan at least temporarily in July.

Daley serves as an ad hoc membe of the California stem cell agency's grants review group and served on the advisory panel for its strategic plan. In June Klein was named to the ISSCR's advisory group.

The text of the ISSCR letter, which was provided to the California Stem Cell Report by Klein, follows in the item below.

Text of ISSCR Letter

Here is the text of the letter from the ISSCR concerning the Northern California county land development/research center proposal.

July 11, 2007

The Honorable Supervisor Mariko Yamada, Chair
Yolo County Board of Supervisors
625 Court Street, Room 204
Woodland, CA 95695

Dear Supervisor Yamada,

The International Society for Stem Cell Research (ISSCR), which represents over 2500 scientists, ethicists, and clinical researchers in the field of stem cell biology from 47 countries, heartily endorses the concept of an International Center for Regenerative Medicine at the Davis Ranch site, dedicated to the translational development of new therapies.

There is a severe shortage of funds for bridging the gap between academic discovery research and industry-sponsored clinical development. This gap of funding is a harsh place where small firms struggling to bring regenerative medicine to patients receive very little support from government and/or private investors. The need for philanthropic support of medical research has never been more urgently needed than today. The substantial gift offered by the Tsakopoulos Family would create a Translational Medicine Development Fund to bridge the gap between basic research and tangible potential therapies and/or cures for seventy or more chronic diseases and
injuries within the field of regenerative medicine.

We also endorse this unique concept because it will bring international institutions together and create a critical mass of scientific research that will allow collaboration and progress in a way that has never been seen before. This exciting proposal would create a world class model for scientific research and collaboration that is the first of its kind.

We strongly encourage you to study this concept as a part of a general plan to bring economic development to your county. We believe that stem cell research will inevitably spawn commercial interest and change the lives of your residents and millions of Americans who live with intense suffering and face premature death. We urge you to carefully consider this unique and innovative proposal to find therapies and/or cures to treat devastating illnesses and injuries.

Respectfully,
George Q. Daley, MD, PhD
President, ISSCR

New CIRM Director, Salk, UC San Diego, Coziness and Much More

The Salk Institute for Biological Studies seems to be doing well in connection with the $3 billion stem cell agency. So is the University of California campus in San Diego.

At least so it appears from the latest appointment to the 29-member Oversight Committee that serves as the board of directors for CIRM. On Friday (Aug. 31), Democratic Lt. Gov. John Garamendi announced that he had named Marsha Chandler to the committee as one of four executive officers from a California research organization who sit on the panel.

Chandler is executive vice president and chief operating officer of the Salk Institute in La Jolla, Ca., a job she has held since July 1. That was the date when Richard Murphy retired both as president of Salk, which is a $100 million-a-year enterprise, and from the CIRM Oversight Committee. Early in August, Murphy was hired for six months by the Oversight Committee to serve as the interim president of CIRM. Murphy has said he will not participate in any matters affecting Salk. Chandler was appointed to fill the vacancy left by Murphy's departure from the Oversight Committee.

Prior to joining Salk, Chandler was the No. 2 executive at the UC San Diego campus. The dean of the medical school there, David Brenner, also serves on the Oversight Committee.

The Oversight Committee awards research and lab construction grants to academic institutions such as the University of California and non-profit institutions such as Salk. The committee also sets the rules and standards for awarding the grants. Oversight Committee members are barred by law, however, from voting directly on grants to institutions in which they have economic ties.

So far UC San Diego has received $14.8 million in CIRM grants. Salk has received $6.6 million.

Similar relationships exist involving CIRM and other UC campuses, other universities and other nonprofits, and it all appears suspiciously cozy to many outsiders. But there is no evidence of any wrongdoing. Nonetheless, the links between the persons who control the $3 billion in taxpayer funds and the beneficiaries of that largess virtually demand that the Oversight Committee and CIRM operate with more openness and transparency than most other state agencies or the NIH. Those entities are subject to executive and legislative controls from which CIRM is constitutionally exempt. The stem cell institute, however, has been reluctant at times to make its operations totally transparent. For example, it refuses to disclose the names of public or private universities or research organizations that seek grants until after the grants are approved, which makes it impossible for the public or other interested parties to comment.

Chandler's academic background is in political science, but she has been a university administrator for nearly 20 years. At Salk she fills a newly created position, one aimed at giving Salk's yet-to-be-named, new president more time for scientific work. Ironically, CIRM cannot easily make similar executive management changes because its executive structure is locked in state law that, for all practical purposes, is impossible to change. Chalk that up to the drafters of Prop. 71, the ballot initiative that created CIRM. For readers not familiar with California law, an initiative is drafted by private individuals, usually in secret and outside of the legislative process. We have never seen a list of all the persons involved in drafting the language of Prop. 71, but California stem cell Chairman Robert Klein takes credit for writing most of it.

A check of news sources shows that Chandler has not made headlines in San Diego, although her name surfaced along with many others in stories about the UC executive pay flap and a piece in the San Diego Union-Tribune about the UC housing assistance program. Ironically, CIRM is barred by law from offering such housing assistance in its search for a new, permanent president.

Two vacancies still exist on the Oversight Committee, and it is not known when they will be filled.

(An appeal to readers: If you know of the names of individuals who participated in writing Prop. 71, please send their names along to the California Stem Cell Report – djensen@californiastemcellreport.com. Or you can just post them anonymously, if necessary, by clicking on the word "comments" below.)

Klein Speaks Out on Presidential Search

California stem cell chairman Robert Klein today defended the conduct of the search for a permanent president of his agency, declaring that there is "great interest" in the opportunity to head the $3 billion enterprise.

In an op-ed piece in The Sacramento Bee, Klein responded to a Bee editorial Aug. 12 that summarized issues complicating CIRM's presidential search, which we have written about on this blog and for Wired.com. The institute has operated in a lame-duck management status since early last December. Some CIRM Oversight Committee members worried as early as last January about the negative impact of a lengthy search.

Klein wrote:

"The CIRM governing board is committed to recruiting a new president who can provide the global strategic leadership this position requires. Academic searches for comparable positions traditionally take 12 to 18 months. Our recruitment effort has a more aggressive schedule; but as I stated in an interview with The Scientist, recruiting a great scientist with a proven record in directing and managing major ongoing research involves finding medical scientists who can take over existing grants, assume the responsibility of mentoring graduate students and post-doctorate students in the labs, and assume the institutional management responsibilities for leading the stem cell efforts of a major university or research facility."

That statement seems to indicate that the board is currently committed to finding an active scientist with a major research portfolio that he or she would have to give up to become president of CIRM. It also seems to mean that the board is not actively pursuing candidates who would be top notch administrators but have a lesser scientific pedigree.

Fresh Comments

Comments have been posted on the Burger King item below from David Hamilton and David Jensen.

Chris Scott: Rocky Road Ahead for CIRM

A onetime candidate for the presidency of the California stem cell agency today outlined his views of the challenges facing the agency in the next 12 months or so. They include the "K-factor," the politics of the CIRM Oversight Committee and micromanagement.

Christopher Scott, head of the Stem Cells in Society Program at Stanford, said, among other things, in an op-ed piece in The Sacramento Bee:

"The institute must quickly find a replacement for (its No. 1 scientist, Arlene) Chiu and double its staff; put in place efficient mechanisms for research and ethical oversight; generate new rounds of proposals, renewals and reviews."

The Bee noted that Scott had been a candidate earlier for the permanent presidency of the institute but said he is not a candidate currently.

Scott wrote that Richard Murphy, the new interim presidency of CIRM "should demand more control over the institute's budget line items and governance decisions while listening to the strong personalities on the citizens committee and in Sacramento."

Scott said:

"The Red Cross collapsed under the weight of its hydra-headed board; the difficult issues centered on control and the dysfunction of consensus management. CIRM faces some of the same problems. Paying attention to the needs of the major players and being flexible to alternate views will help him balance control."

Scott continued, hitting various topics:

"The K-Factor. Robert Klein(chairman of the Oversight Committee) is a blue-chip entrepreneur, passionate advocate and hero to many. His forceful personality and charisma made the institute what it is, but these qualities may not be suited for efficiently executing its mission. Though Klein has said he will step down in 2008, some founding entrepreneurs mistime their exit. Murphy will have to deftly manage Klein's freewheeling ways, leveraging his strengths while covering his weaknesses. Checking the ego at the door will help."

Scott wrote,

"Secession. Any executive who has worked in a startup knows six months will pass in an instant. A permanent president must be found, one who can handle the political challenges while tending to the small stuff, the decidedly unsexy but essential routine of ramping up and running a large research granting agency."

He concluded:

"CIRM's second phase is more important than the first. California voters put their money on the line for a vision of science and medicine. Now comes the hard part. The institute must execute the plan, bringing new knowledge, discoveries and therapies to California."