Monday, January 31, 2005

Temp Wanted

Perhaps we missed it, but the California stem cell agency wants to hire only an interim president at this point, rather than a permanent CEO.

The temp should be willing to serve for six to 12 months. Of course, that person will be considered for the permanent position as well.

You can find details on the job specs, which should start within six weeks, on the California Institute for Regenerative Medicine web site here. You can file your application online if you like.

Sunday, January 30, 2005

Basic Information Misssing

Nearly another month has passed since the last meeting of the Oversight Committee for CIRM, and we still see grossly inadequate material available in advance of the latest round of meetings.

This week both a subcommittee and the full oversight committee are meeting. Yet only the sketchiest material is available on the CIRM's website. The issues that the committees plan to discuss are basic and important. They include the strategy for awarding grants, development of conflict of interest policy and consideration of qualifications for candidates for president.

Perhaps we are incorrect, but certainly members of the committees will be presented with written reports and background information at the actual meeting. Minutes from previous meetings are scheduled to be approved. Yet none of this available online. No plans have been announced to provide it to persons attending the teleconference sessions at remote locations.

CIRM would do well to follow, as much as possible, the example of California's state and local legislative bodies. In many cases, they cannot legally act on measures until they have been available to the public for several weeks. Without such access, CIRM functions in partial obscurity.

CIRM is still very much a fledgling organization, and due some forbearance. But making information available in advance of the meetings is easily done. It is also basic to the accountability and openness that should be the hallmark of the stem cell agency.

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Comments on the conduct of CIRM and the failings of this blog are welcome. Please send them to djensen@californiastemcellreport.com.

New Links Added

We have added some new links from this blog to other sites that have information on stem cell issues, dealing with both policy and science matters.
Some folks have wondered whether we endorse sites just because this page carries links to them. The answer is no. We link to sites because they seem interesting or useful. But we encourage you to visit them.


Here are the latest links that have been added: The Regenerative Medicine Society, Today's Stem Cell Research, Law Under the Microscope.

Plot Afoot in San Diego

According to Terri Somers of the San Diego Union Tribune: "San Diego's business community is plotting how it might offer millions to subsidize scientists to move to Torrey Pines Mesa, the center of the region's stem cell effort. " Read her article here.

The Readers Write

(Please send your comments on CIRM and the failings of this blog to djensen@californiastemcellreport.com. )


Interest and Conflicts Examined
The following was received from the "Old Country Lawyer" in Temecula CA:

"I took the time to read Proposition 71 in some detail a few days ago and have concluded that it is not as bad as I had first thought, at least as regard to potential conflicts. It contains provisions regarding conflict of interest that seem to comport with the general law, in that it both requires disclosure and would prohibit a committee member from voting on matters in which he had a direct financial interest. But the language is a tad equivocal. It says:

'c) Assets and income of public officials which may be materiallyaffected by their official actions should be disclosed and inappropriate circumstances the officials should be disqualified fromacting in order that conflicts of interest may be avoided.'

"Note the use of the term, 'appropriate circumstances.' What does that mean? To me, it says that the writers have foreseen circumstances in which it may be appropriate for a member to vote regardless of his interest. It could be that it is a reference to university employees who are also voting members, but that situation has been directly addressed and excluded from the conflict laws.

"The act also purports to exempt a member from the conflict laws if he votes on a matter of financial interest to one of his competitors. And, in an interesting provision, the meaning of which is obscure, it limits the effect of the conflict of interest laws only to situations where the member not only had an interest, but also actually voted on the issue. I wonder why they thought this necessary? I suspect it may have to do with the requirement of liberal interpretation set forth in the Government Code.

"A liberal interpretation of the financial interest definitions in the Government Code would probably preclude a member acting on any aspect of a competitor's grant, but the various members may find themselves discussing in private session various scientific aspects of either their own or a competitor's grant anyway. Thus, it may be that they are seeing this as acceptable as long as the member does not actually vote on the matter.

"At any rate, the intent behind all this is not very clear, and when such an act attempts to overrule general law provisions on matters as important as the conflict of interest provisions of the Political Reform Act, I suspect the courts might view such attempts with a jaundiced eye. I certainly would. But this is not to say that I think the act would be subject to complete disapproval because of such ambiguities. There is a saving clause that would maintain the basic provisions of the act if any part of it were to be found improper, and in that case the conflicts portion would then be governed strictly by the general law. Either way, it would probably be OK.

"I do not see any great conspiracy behind any of this, but rather an attempt to shape the potentially unique circumstances of scientific inquiry into the cracks of the often arcane conflict laws. They may have succeeded. Then, again, perhaps they did not. Ain't the law fun?"

Saturday, January 29, 2005

New Legislative Subcommittee For CIRM

Everybody is friendly about all this, but Sen. Deborah Ortiz, D-Sacramento, is making it clear that concerns about accountability on the part of CIRM will be heard.

She has created a special subcommittee to air issues involving CIRM. She called it a "larger forum" than the CIRM's own oversight committee.


Carl Hall of the San Francisco Chronicle interviewed Ortiz about the matter. His brief
article said hearings were likely late February or early March as Ortiz presses her CIRM accountability legislation. As for CIRM's reaction. Hall reported the following:

"'We certainly welcome her interest, ' said a spokeswoman for (CIRM chairman Robert) Klein. 'We obviously look forward to working collaboratively with her.'"

For more on this subject see, the "hammer" item on this blog, filed Jan. 23.

Friday, January 28, 2005

Rich Guys Redux

Wall St. Journal columnist David Wessel, who wrote the “rich guys” piece about Robert Klein, revisited the subject on the Journal's website. This time he ran comments from a number of readers.

Here are the remarks of two:
Susan Daniels: “Pray tell me this: How does what Messrs. Klein and Reiner did differ from Texas oilmen buying (legally, of course, through campaign contributions) the right to set US energy policy, differ from timber interests buying (legally, of course, through campaign contributions) the right to set forestry policy? I could go on and on. I guess the only difference is that what Messrs. Klein and Reiner did wasn't under the table and might actually benefit more than the richest one-tenth of one percent of the population. If you hadn't focused only on liberal rich guys with causes and while ignoring rich conservative rich guys with causes, it might have had more credibility. Washington is a cesspool and both parties are to blame -- but that doesn't mean you should write a column that would make any rational person assume you are an idiot.”

Wessel's response: “I think The Wall Street Journal has done a pretty darn good job of covering the influence of money in politics -- of all kinds of political coloration."

Joel West: “You (Wessel) were way too easy on the threat that rich activists pose to our democracy. Ballot box initiatives and California mass media politics have had their risks all along. But Messrs. Reiner and Klein have perfected a system that transfers control of taxpayer money away from elected officials to unelected, self-perpetuating bureaucracies.“In particular, Mr. Reiner has been using state tax revenues to run an unprecedented propaganda campaign to create a permanent consensus that state-supported preschool is an inalienable right. State law (plus an activist press) governs how public officials can use public money to lobby the public -- but Mr. Reiner (and now Mr. Klein) are exempt.“Part of the blame lies, however, with the big city media that endorsed the anti-Bush stem cell initiative despite its fatal flaws (documented in a commentary by Francis Fukuyama in the Wall Street Journal on October 25). And our governor showed his "girly man" side by running to the front of Mr. Klein's parade rather than pushing for essential accountability reforms.”

Wessel did not respond to West's comment.

Near-term Commercialism

Reporter Amy Tsao for Business Week Online wrote about the contaminated stem cell issue this week. Here is part of what she had to say:

“The finding is already fueling frustration among academic researchers in the U.S. And it is likely to accelerate efforts by states to fund their own stem-cell initiatives on the model of California's Proposition 71, as well as programs at privately backed companies. 'We need to look at approaches that are not within the boundaries of federal funding,' says David Scadden, co-director of the Stem Cell Institute at Harvard.

“There's nothing wrong with state-funded or private programs, of course. In fact, they may go a long way to offset the federal government's underwhelming commitment to this important field. Still, many of these efforts are likely to be focused on near-term commercial development, not on basic science. And no matter how you slice it, it's unfortunate that U.S. laboratories backed by the most prestigious federal grants will be placed at a disadvantage, vis-a-vis other researchers.”

Thursday, January 27, 2005

CIRM's New HQ? The CEO reality

Want to know the likely location of the new, permanent headquarters of the California Insitute of Regenerative Medicine? Ask the new president?

San Francisco, San Jose, San Diego, Sacramento, Los Angeles – all are battling for the 15,000-square foot facility with 50 employees. Tiny in corporate space terms, but meaningful is the word.

Incentives are being bandied about. Free rent and the like. But is San Diego going to come up with a package similar to that provided to the Chargers football team? Not likely. The city fathers in San Diego put their cash where they think it is important – football -- not stem cells.

The whole competition is probably moot. A study some time ago on corporate location decisions determined that the key factor is where the chief executive wants to live. And that person is the yet to be selected. You can bet that Robert Klein, chairman of CIRM, will want to hold out the location of CIRM's permanent headquarters as a recruitment tool for the CEO that he is seeking.

Of course, if Klein really wants to be in total control of the agency, he may deem that it is necessary for the headquarters to be very close to his real estate operations in Palo Alto, which makes a lot of sense anyway.

Any sensible CEO would choose a location in the San Diego area. The weather is much better as are living conditions, compared to the Bay Area. Forget Los Angeles totally. Regarding Sacramento (where I used to live), what can you say about a city known as the Big Tomato?

As for the temporary headquarters, Klein should select a site close to his firm in Palo Alto. Given that he is the engine on all this, there is no point in the interim offices being any distance from his normal location. He can't lease his own space to the institute. It would look bad. So rent something in San Mateo, Redwood City or other nearby location for a starter. Actually, given the nature of the institute, Klein should find a public-minded enterprise to provide the interim space free – let's say the Center for Genetics and Society in Oakland.

Here are links to stories on HQ location issue: San Francisco Chronicle, San Diego Union Tribune, The Associated Press. The Los Angeles Times and The Sacramento Bee web sites show no staff stories on the latest on the HQ process. If you know of other sites with stories on the matter, please send them along to djensen@californiastemcellreport.com.
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Send your comments on CIRM or the failings of this blog to djensen@californiastemcellreport.com. We publish almost anything.

Tuesday, January 25, 2005

Solitary Update on Presidential Search

If you want to know what the presidential search committee did Monday, you won't read about it the major California newspapers.

We may be wrong, but it appears the Silicon Valley Business Journal -- Reporter Timothy Roberts -- was alone with a report on the committee.

The lead of his story said: "The committee searching for a president for the state's stem cell initiative acted today to limit a potential conflict of interest. The presidential search committee of the California Institute for Regenerative Medicine voted unanimously to prohibit board members from voting on the candidates who work at institutions with which the board member is affiliated. "

The Readers Write

We would be pleased to publish comments on the California Institute for Regenerative Medicine or the failings of this blog. Please send them to djensen@californiastemcellreport.com.

Reader Tom Hall, a retired historian living in Berkeley, CA, weighed in with some thoughts
triggered by the “rich guys” column in the Wall St. Journal:

“Wessel worries about who these rich-guys-turned-heads-of-state are actually accountable to. He should be concerned, but I am surprised that he doesn't take the next step. Prop. 71 has simply made explicit what was always latent in Hiram Johnson's initiative and referendum reforms. And I don't mean the sorry situation where the rich have subverted reforms that were intended to free government from the control of railroad tycoons. Rather, Prop. 71 has simply exposed what was always wrong with the initiative and referendum: They are a terrible blow struck against representative democracy and its system of accountability. We can always vote out the rascals in Sacramento; but how do we get rid of the Reiners and Kleins of Hollywood and Palo Alto? I think it is time we junk Hiram Johnson's misguided reforms and insist that the legislature do what it is supposed to do: legislate. Certainly there will be times of gridlock. But they don't last forever and more importantly they are a normal part of the messy business that is democracy.

“I also don't think that it is a good idea to hand the keys of government over to self-appointed advocacy groups. That is another of Prop. 71 little wrinkles. The new law gives certain advocacy groups -- some of whom consist of families of people with degenerative diseases -- a formal role in the making and administration of policy. Klein's defense of this aspect of the proposition is a nice bit of 21st century cynicism. 'Scientists sometimes back very good ideas, but not the best ideas, because they are put forth by colleagues in other universities,' he argues. 'Patient advocates are committed to push the frontiers of knowledge.'

“Here I am not so concerned with Klein's unsupported assertion of scientific culpability. Nor am I exercised by his naive belief that 'patient advocates' are free from self-interest or that they have some monopoly over scientific wisdom. Rather I am worried about the implications of formally investing advocacy groups with public power. These are men and women with no professional credentials. They are vetted by no professional group.Yet under Prop 71 they will have a direct role in making scientific policy and influencing the course of research.

“Are we to expect new initiatives that would, for instance, give families of autistic children
the formal power to pass on educational policy? Or how about a new law that would give the state Chamber of Commerce official authority over the budgets of all public regulatory agencies.


“Prop. 71 doesn't just create parallel governments, it invests private groups with public power in ways that weakens representative democracy. It is reminiscent of the worst aspects of Franklin Roosevelt's National Recovery Administration and the corporate fascism of Italy and Germany that were its contemporaries.

“Wessel ends his little piece predicting that 'if the research proves fruitful, no one will
whine about accountability.' He may be right. But success won't resolve questions about how far Klein's method of conducting the public's business threatens representative democracy. No one complained when the Italian fascists made the trains run on time. Look where that got us.”


Tom, thanks for your comments.

Monday, January 24, 2005

LA Times to CIRM Cynics: Stand Aside!

The Los Angeles Times was quick to weigh in with an editorial on the significance of the contaminated stem cell issue in California.

Writing in today's edition, the Times said that the disclosure of the bad stem cells "shows why California's $3-billion stem cell research program — approved by ballot measure last fall — has to start delivering dollars to scientists.

"Its progress must not be hindered by interest groups that would like to prohibit it from issuing any grants unless discussions are conducted in public."


CIRM Presidential Speculation

Timothy Roberts writes in the Silicon Valley Business Journal that two names "are being tossed around" as candidates for presidency of the California Institute for Regenerative Medicine.

They are David Kessler, the former commissioner of the U.S. Food and Drug Administration who is now dean of the University of California at San Francisco School of Medicine, and Richard Atkinson, former president of the UC system. Roberts said they could not be reached for comment.

The report comes as the presidential search committee meets today.

Sunday, January 23, 2005

The Senator's Hammer

California's new stem cell agency has a hefty legislative hammer hanging over it, one that is not likely to fall statutorily but one that could serve as a tool to arouse the public, perhaps as early as March.

The state legislation is aimed at ensuring full disclosure of financial and other interests, open meetings of governing and working groups “to the fullest extent possible” and tough patient protection standards.

California State Sen. Deborah Ortiz, D-Sacramento, introduced the measure although she was a strong supporter of Proposition 71.


She said Proposition 71 “fills a critical void” and “offers immense promise for developing new medical therapies.” But she added, “If we falter in any way or allow any level of cynicism or doubt to step in, we will lose a great opportunity in history.”

Despite her support for the initiative, Ortiz said it is “glaringly short in providing key protections to the public's pocketbook.”

She wants the state to take steps to ensure a “fair financial return” to California on its investment in the agency. The economic disclosure requirements in the proposition are not “good enough.” The agency's working groups are exempt from state open meeting laws, creating a situation rife with the potential for abuse, according to the senator. And she wants patient protections reinstated that the initiative pre-empted.

The initiative may be nearly impossible to modify by legislative action this year, but Ortiz says she is willing to try. Her press aide, Hallye Jordan, told the California Stem Cell Report that hearings on the senator's bill could come as early as March. Jordan also said Ortiz is considering asking the state auditor to examine at the institute at some point.

Given the difficulties in actually turning her proposal into law, Ortiz' bill seems to serve primarily as a device to be sure her views are given very serious consideration by the new agency.

It would be awkward for agency officials to stand before a legislative hearing chaired by Ortiz and say they are against measures to protect the public and patients. Nonetheless, that is increasinglyclose to the position they find themselves as one news report after another contains criticism of their alleged lack of accountability and purported conflicts of interest.

Late last week, for instance, came word that four members of the oversight committee failed to file economic disclosure statements by the deadline required by law. The 2 million subscribers of the Wall St. Journal were told that the agency is run by a “rich guy” who lacks accountability. (See items below.)

The stem cell institute, in some ways, positioned itself early on as something of a Sister Teresa of the bureacracy – curing the sick and helping the lame. But public's faith in government is limited. Good reputations can vanish overnight in the wake of even a mini-scandal.

All of which means that Sen. Ortiz' concern that that the agency could fritter away a great opportunity deserves serious thought.

For more on Ortiz' thoughts, see the piece she wrote in the San Francisco Chronicle and information on the legislation on her website.
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We would glad to publish your thoughts on the stem cell agency or the failings of this blog. Please send them to djensen@californiastemcellreport.com.


Policy Entrepreneuers Whacked

One might assume that the Wall St. Journal would be a friendly place for "rich guys," especially ones willing to assume leadership in areas that government is loath to tread.

But not so, at least in the case of a report last week that was headlined “Rich Guys With Causes Lack Accountability.”

The
column was written by David Wessel, who shared two Pulitzer prizes and is deputy bureau chief in Washington. It was about Robert Klein, head of the California Institute for Regenerative Medicine.
Wessel said that the latest twist in direct democracy is found in California, “that font of innovation.”

“...(A) rich man with a cause proposes a ballot initiative to spend taxpayer money on something the gridlocked state legislature won't back. He puts a lot of his own money into a successful campaign. When it passes, he takes charge of spending the money.”

As examples he cited Gov. Arnold's after-school care measure and filmmaker Rob Reiner's tobacco tax/school support proposal, both of which passed a few years back, as well as Proposition 71, which Klein backed.

“These policy entrepreneurs essentially didn't trust the government to do the job right so they set up a parallel government,,” Wessel wrote. “All this is understandable, even admirable, for (men) who could easilybe shopping for sports cars. But is it wise?”

Wessel concluded that “Mr. Klein is walking a fine line between promoting scientific research free of political constraints and using his mastery of the initiative process to create a taxpayer-funded institute that he essentially controls. If the research proves fruitful, no one will whine about accountability. If it doesn't, though, he will get the blame.”

Wessel's item was a column – not a news story. The official position of the WSJ's editorial page may be different.

Four Miss Filing Deadline

Four members of the oversight committee missed the deadline for filing their statements of economic interest.

Laura Mecoy of The Sacramento Bee reported the failure to file in a
story that also said that 10 of the 29 committee members “serve on biotech or pharmaceutical firms' boards of directors or have extensive holdings in those industries, leading critics to challenge their ability to fairly represent taxpayers in doling out $3 billion in state funds.”

The statements of economic interest are usually referred to as conflict-of-interest statements and are required to be filed with California's Fair Political Practices Commission. They do not actually disclose conflicts-of-interest, but rather information about the holdings of committee members. Whether those holdings constitute a conflict-of-interest is a legal or ethical judgment.

Thursday, January 20, 2005

CIRM Shows Us The Money

Members of the CIRM oversight committee have filed the first set of official disclosure documents regarding their financial holdings. Lest you get your voyeuristic hopes up, the statements are fairly general, basically confirming that many of the committee members are wealthy.

Several of the major California newspapers ran stories on the filings and reaction to them. Carl Hall's story in the San Francisco Chronicle had this paragraph:

“ 'It would be naive for anybody in California to believe the good-old-boy network is not at play here,' said Deborah Burger, president of the California Nurses Association, which opposed Proposition 71.”

Lisa Krieger and Paul Jacobs of the San Jose Mercury News filed a story that noted that CIRM Chairman Robert Klein has made millions during his career in real estate. The story went on:

“As a member of the subcommittee seeking a site for the taxpayer-funded institute, Klein will be in a position to influence decisions affecting commercial real estate in the chosen community. He also has temporary authority to hire staff and to rent short-term offices during the start-up phase of the program.”

Hall had this nugget near the end of his story on the wealthy committee members:

“At the other end of the spectrum, Dr. Josephine Phyllis Preciado, a Fresno physician appointed to the stem cell board because of her advocacy for low-income people and minority communities affected by diabetes, filed one of the shortest forms, detailing only one outside source of income: her husband's salary as a sales associate at Home Depot.

“Preciado said her spouse, Kevin Sutter, is a handyman who has spent most of his time lately rearing the couple's two children and remodeling their home. She added that he is no relation to the namesake of Sutter Health, the prominent California health care provider.

“'He doesn't even like to go into hospitals,' Preciado said.”

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We welcome your comments on CIRM or the failings of this blog. Please send them to djensen@californiastemcellreport.com.

More on CIRM Web Site

The web site for the California Institute for Regenerative Medicine (CIRM) is slowly adding information. Now available are lists of members of the oversight committee and the search committees.

The list of the oversight committee includes their business and titles and the categories to which they were appointed, such as patient advocate or “representative of a commercial life science entity.”

The members of the presidential and site search committees are also identified as are the members of the working group search committee and its subcommittees on standards, grants and facilities.

Wednesday, January 19, 2005

A Missed Deadline: What Does It Mean?

The California Institute for Regenerative Medicine appears to have missed its first legal deadline – not that it means much, at least for now.

Monday Jan. 17 appeared to have been the deadline for appointment of members to the three working groups by the oversight committee. But no action had surfaced as of late Tuesday. Instead the search committee for the research funding working group scheduled a teleconference meeting for Jan. 25 to determine criteria for selecting members of the research working group.

There does not appear to be any penalty for missing the deadline, just as there is virtually no penalty for failure of the legislature and the governor to enact a state budget on time. Moreover, a substantial number of folks make persuasive arguments that CIRM needs to go slow and exercise great care in its proceedings.

Nonetheless, a skeptic might wonder whether this is the first step along a path that skirts the requirements of the law when the institute thinks it is necessary.

At any rate, the unknown person or persons who wrote that deadline into the initiative is the one who deserves the raspberry. It was totally unrealistic. If the measure had gone through the legislative process, perhaps it would not have contained such foolishness. But then again, it may have contained worse.

Credit Stu Leavenworth, an associate editor of The Sacramento Bee, with noting the Jan. 17 deadline in his
Jan. 9 piece on CIRM.

If you are a glutton for punishment, you can find the deadline in section 125290.50 of the measure. Our browser showed it on page 5 of the
PDF file of Prop. 71 on the California secretary of state's site.

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We would be delighted to publish your comments on the CIRM or the failings of this blog. Please send them to djensen@californiastemcellreport.com.

Sunday, January 16, 2005

Klein Profile, Congress Thwarting?

The San Jose Mercury News has an interesting piece by Lisa M. Krieger and Paul Jacobs that profiles Robert Klein, the head of the California Institute for Regenerative Medicine. Among other things, it says that he has emerged as one of the most powerful figures in state government.It also says that he was involved in lawsuits with former business partners, a bank, a neighbor, his stepmother and his brother. That might sound scandalous, but the details appear less so.

In the San Francisco Chronicle, another writer, David Duncan raises the possibility that a Republican-dominated Congress might do something to thwart California's stem cell agency. The piece, however, does not name any legislators who might be considering such a move.


Meeting, Meetings, Meetings, But More is Needed

If you are interested in following the affairs of the California Institute for Regenerative Medicine, you better cancel most of your plans for Jan. 25 and part of Jan. 24. The agency has scheduled three teleconference meetings, which means that the meetings will held in one location and broadcast to several locations elsewhere in the state.

The site search committee is meeting from 11 a.m. to 1 p.m on the 25th. You can fill that afternoon with a 4 p.m. to 6 p.m. meeting of the scientific and medical research fund working group search committee. The business of the site search committee is obvious. The scientific research group will consider, among other things, grant formats and criteria for selection of members of the research working group, which is not the same thing as the search committee for the research working group, which is the one actually meeting on Jan. 25. This may sound confusing, but one can only do so much with the names of groups that are nearly identical.

In other agenda news, the presidential search committee meets in teleconference mode on Jan. 24 from 9 a.m. to 11 a.m. to consider responses from personnel search firms seeking to conduct a search for a president for CIRM. If you are a such a firm, the deadline for proposals is Jan. 19, Wednesday, at 5 p.m.

Comment
:
This seems to be a good use of teleconferencing to allow interested parties to actually hear the meetings from various locations around the state. (See the locations and agendas at the CIRM web site.) However, there are several problems. Listeners will not be able to see any documents, such as search firm proposals. The actual members of the committees are not listed. No procedures for voting are laid out, including what consitutes a quorum for these committees. This is a young agency with a host of start-up issues. But it is time for it to publish procedures that lay out how it works beyond what is in the actual initiative, if it has such procedures. While we are on the subject, it is past time for CIRM to publish some version of minutes of previous meetings. This is standard procedure for other government agencies and should not be neglected. It would also be a good idea to broadcast all meetings via the Internet instead of to specific locations. Access would be much improved.



Thursday, January 13, 2005

Good Enough for the Golden State?

A blog on the website of the American Journal of Bioethics has raised questions about reliance by California on national standards for stem cell research.

The item on blog.bioethics.net by Glenn McGhee reacted to a piece in the San Francisco Chronicle today by Carl T. Hall. McGhee said it would be helpful for California to get the Moreno committee report discussed in Hall's piece.

"But it is difficult to see how any group writing guidelines for national stem cell policy - or even for state and national policy - can cover both the issues inherent in national dilemmas, and the issues present in the states' differing legal, clinical, political, economic, and social situations, and still be finished in eight months," he said.

"It remains to be seen whether California will create its own ethics group or ethics research division within Proposition 71, and it would be dangerous indeed for the state to avoid doing so. California state stem cell policy might not be something you want - for the long term anyway - to have "phoned in" at the last minute. What Californians really need to do is hire Jonathan Moreno away from Virginia! "

CIRM Waits on National Research Standards

The California Institute for Regenerative Medicine is waiting on national research guidelines before beginning the process of making grants -- guidelines that may be in place in April.

The timetable was disclosed in an
article by Carl T. Hall in today's (Jan. 13) San Francisco Chronicle. Hall quoted Robert Klein, chairman of the CIRM oversight committee as saying he never meant to set a "firm" May deadline for dispensing funds. Klein said the agency would not issue grants until the best standards were in place.

Hall wrote, "Klein is counting on a comprehensive set of stem cell guidelines from the prestigious National Academies, an independent research organization in Washington, D.C., to help speed things along."

The organization said the standards will not be ready at least until April. Presumably those standards would be adopted on an interim basis by CIRM, triggering the first grant cycle. Then the agency would have 270 days to adopt final rules.

Wednesday, January 12, 2005

The players on the oversight committee

Here is a complete list of the members of the oversight committee for the California Insitute for Regenerative Medicine as prepared by Stu Leavenworth, associate editor of The Sacramento Bee. The list was first carried in his nice overview of the agency in Sunday's Bee.

*Chair*
* Robert Klein II
Portola Valley developer and board member of the Juvenile Diabetes Research Foundation (nominated by Gov. Arnold Schwarzenegger and other state officials)

*Vice Chair*
* Edward Penhoet
Co-founder of Chiron Corp. and current president of Gordon and Betty Moore Foundation, a San Francisco philanthrophy (nominated by Lt. Gov. Cruz Bustamante and state Controller Steve Westly)

*Appointed by Schwarzenegger*

* Keith Black
Director of the Maxine Dunitz Neurosurgical Institute and director of neurosurgery at Cedars-Sinai Medical Center

* Brian E. Henderson
Dean of University of Southern California's Keck School of Medicine

* Oswald Steward
Chairman and director of the Christopher Reeve-Irvine Research Center for Spinal Cord Injury at UC Irvine

* Leon J. Thal
Chairman of the Department of Neurosciences at UC San Diego and director of its Alzheimer's Disease Research Center

* Gayle Wilson
Wife of former Gov. Pete Wilson; corporate board member of Gilead Sciences Inc., a pharmaceutical firm, and other companies

*Appointed by Lt. Gov. Carlos Bustamante*

* Josephine Phyllis Preciado
Executive director of the Diabetes Research network, Fresno Collaborative, UC San Francisco; and executive director of the Latino Center for Medical Education and Research, Fresno

* Tina S. Nova
President and chief executive of Genoptix Inc. in San Diego

* Richard Murphy
Chief executive officer of the Salk Institute for Biological Studies

* Robert J. Birgeneau
Chancellor of UC Berkeley

* David Serrano Sewell
San Francisco deputy city attorney

*Appointed by state Treasurer Phil Angelides*

* David Baltimore
President of the California Institute of Technology

* Dr. Michael Friedman
President and chief executive officer of City of Hope, a research and treatment center

* Michael Goldberg
Venture capitalist from Woodside

* Dr. Francisco Prieto
President of the American Diabetes Association's Sacramento-Sierra chapter

* Janet Wright
Chico cardiologist and member of the American College of Cardiology

*Appointed by State Controller Steve Westly*

* Ted W. Love
President, chief executive and director of Nuvelo Inc., a biopharmaceutical company based in Sunnyvale

* Joan Samuelson
Founder and president of the nonprofit Parkinson's Action Network

* Philip Pizzo
Dean of Stanford Medical School

* John C. Reed
Chief executive of the Burnham Institute

* Sherry Lansing
Chairwoman and chief executive of Paramount Pictures' Motion Picture Group

*Appointed by Assembly Speaker Fabian Núñez*

* Jonathan Shestack
Founder of Cure Autism Now and producer at Warner Bros. studios

*Appointed by former Senate President Pro Tem John Burton*

* Jeff Sheehy
Deputy director for communications at UC San Francisco, AIDS Research Institute

*Appointed by UC chancellors who have campuses with medical schools*

* Susan V. Bryant
Dean of the UC Irvine School of Biological Sciences and professor of development/cell biology

* Edward W. Holmes
Dean of the UC San Diego School of Medicine and vice chancellor of UC San Diego Health Services

* David Kessler
Dean of the UC San Francisco School of Medicine and former head of the Food and Drug Administration

* Gerald S. Levey
Vice chancellor of UCLA Medical Sciences and dean of the medical school

* Claire Pomeroy
Dean of the UC Davis School of Medicine and vice chancellor of UC Davis Human Health Services

Tuesday, January 11, 2005

The story of Florencio


A man named Florencio López-de-Silanes was recently forced out of his job as the prize-winning head of the Yale University's International Institute for Corporate Governance.

López-de-Silanes was so highly regarded, according to a recent
account in the Wall St. Journal, that he was a governance consultant for the World Bank and helped train foreign corporate directors. López-de-Silanes, however, resigned from his position at Yale after he allegedly double-billed the school for about $150,000 in business travel expenses, according to the Journal.

What does this have to do with California's newest agency, the
Institute for Regenerative Medicine?

It has to do with money, trust and temptation, and the public's business.

Some Californians are concerned about how the stem cell agency is handling its affairs. “Trust us” seems to the official position at this point, although it is no easy task to get new bureacratic body breathing.

Dana Parsons, a columnist with the Los Angeles Times, may reflect some of the public unease. Earlier this week she (or is it he?)
wrote that while she was not in full buyer's remorse about Proposition 71, she was feeling a tad edgy.

“It's just that they're dealing with huge amounts of money and huge amounts of hoped-for results. Just as surely as that formula provided the passion for the initiative, it could create pressure to do things too quickly or too much behind closed doors,” Parsons said.

So Parsons called James Warsaw, a “highly honorable” Southern California man who made his fortune in a family sports merchandising business and who supported Proposition 71. Parsons asked for reassurances about CIRM's conduct so far. “I'm reassuring you,” Warsaw said. That was good enough for the columnist.

It certainly does seem to be an appropriate time to trust the new agency, given its newness and start-up travails. That said, the first step in building trust is to create procedures that will ensure that the public's interest is fully protected.

The CIRM oversight committee is filled with accomplished, intelligent and principled people. They will be overseeing the dispensation of $3 billion – an amount that could tempt a saint. Open meetings, open records and strong ethical regulations will go far in avoiding future problems that could sap the agency.

As we know, sometimes even the best people do bad things. Ask Florencio López-de-Silanes.
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We would be delighted to publish your comments about the progress of the stem cell agency or the failings of this blog. Please send them along to
djensen@californiastemcellreport.com.
Suggestions for links are welcome as well
.

Monday, January 10, 2005

From Our Readers

The following is from GLS in Temecula, CA:

With 3 billon dollars at stake, they'd better vet the fund managers for scientific and other conflicts in full public view. Otherwise, we will get a bunch of hacks bought and paid for by the big medical companies.



Note to readers: This blog will publish comments from readers without using their real names, if requested and depending on the nature of the material. Generally, however, we want to know the identity of a person before posting his or her comments.

CIRM Bared ... Sort Of

Want to take a close look at the spending plans of the California Institute for Regenerative Medicine? It is all exposed -- sort of -- in the governor's proposed budget for 2005-06, which he laid out Monday.

However, most readers will find the information less than satisfying. The figures are clearly preliminary and reflect little input from the agency itself, given that the board has only had 1 1/2 meetings and has no staff to prepare a budget. The numbers are pretty much placeholders for more details to come in the middle of May in what is known as the May Revise.

Indeed, the proposed plan's primary value is as a historical artifact. You can read it by clicking
here.

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We would be delighted to publish your comments either on the agency's progress or the failings of this blog. Please email them djensen@californiastemcellreport.com. Send us your suggestions for links as well. Thank you.

Sunday, January 09, 2005

"Biopigs" to Blackberries: Scoring in the Minus Column

California's new stem cell research agency has generated an impressive wave of negative attention in its first month.

All across the nation, the headlines are harsh.

“Fiasco” was the description on MIT's Technology Review website by its Web editor, Brad King. He recently counted 150 stories exploring negative aspects of the California Institute for Regenerative Medicine.

Matthew J. Peterson of Local Liberty, a blog at the Center for Local Government at the Claremont Institute, said the agency was a “monster” created by “big biotech, Hollywood producers, and other wealthy interests.”

Biopigs” are clamoring at the trough, wrote another blogger, Derek Gilbert.

Even Proposition 71 supporter California State Sen. Deborah Ortiz, D-Sacramento, complained in an op-ed piece in the San Francisco Chronicle that the “initiative falls glaringly short in providing key protections to the public's pocketbook.”

The Christian Right was largely silent with the exception of LifeNews.Com, where Editor Stephen Ertelt wrote a “we-told-you- so” piece.


Stuart Leavenworth, an associate editor of The Sacramento Bee, weighed in with perhaps the most thorough-going piece, one that was clearly labelled opinion. Some excerpts:
  • “There is hope this group may end up operating more openly than the law allows and less secretly than some critics fear. But for that to happen, state officials and the public will have to exercise steady pressure, with an awareness of how much is at stake.”
  • “During the meeting, I briefly chatted with (Robert) Klein, tried to arrange a longer interview, and then was dodged by him and his associates. Busy talking and typing into his wireless Blackberry, Klein came across as the consummate business guy, experienced in orchestrating deals but uncomfortable in dealing with the public spotlight.”
  • “Although Klein seemed sincere in wanting to hear public comment, committee member Sherry Lansing, CEO of Paramount Pictures, rolled her eyes and yawned while members of the public addressed the board with their concerns.”
Leavenworth's lengthy article touched most of the bases, from conflict-of-interest concerns to scientific ethics. It is must reading for those following this agency.

Is all this harsh reaction deserved? After all, this is a new agency trying to move very quickly without a staff, right?


Perhaps. But Proposition 71 has a passel of powerful and knowledgeable friends who have operated in the public spotlight for decades. It would have served them well to midwife the birth of CIRM and stanch the flow of negativity. One can hope that Klein and members of the oversight committee today better understand the need to preserve their credibility and the confidence of the public than they did a month ago.



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Who's The Man?

Although CIRM has done a fair job of wounding itself, nobody would know unless somebody told the story. As of this week, the main minstrel is Paul Elias, biotechnology writer for The Associated Press. After the initial first meeting debacle in December, an
article written last week by Elias spawned most of the negative comment and headlines around the country. Why? Because The AP has national and global distribution. TV, radio, newspapers and web sites around the world use AP -- not reports from regional California newspapers. Often AP simply picks up stories from local papers, but in this case the organization has a reporter specifically covering the agency. That means that the folks at CIRM need to focus sharply on Mr. Elias. He is the starting point for national media coverage and will also establish the initial tone for reporters coming in from outside California, such as those from the New York Times, Washington Post, Boston Globe and others.

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We would be delighted to publish your comments either on the agency's progress or the failings of this blog. Please email them to djensen@californiastemcellreport.com. Send us your suggestions for links as well. Thank you.



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