New Issues Added to CIRM Directors Meeting Next Week

The California stem cell agency has altered its agenda for next Tuesday's meeting at Stanford, adding an element to its proposed human egg policy rules and an item dealing with eligibility on a new "translational" grant round.

The agency also posted its latest version of how it would like to define California supplier, which is the key to giving preferences worth hundreds of million dollars to state businesses seeking to sell to CIRM grantees.

The definition can be found here and seems to include almost any conceivable potential vendor in the state, but we could be wrong. At the same time, the California legislature is considering its own definition of California supplier in AB2381 by Assemblyman Gene Mullin, D-San Mateo.

That measure is now on the floor of the state Senate.

(In another CIRM legislative matter, the Assembly floor analysis of SB1565, the bill designed to ensure affordable access to CIRM-funded therapies is now available.)

The item with eggs now says that directors will be asked to authorize "a procedure for petitioning the ICOC to designate stem cell lines derived before November 2006 as acceptably derived for use in CIRM-funded research, and to govern use of embryos created for reproductive purposes before August 13, 2008." Added was the language having to do with the Aug. 13 date.

Also added to the next week's agenda is an item which states only: "Consideration of eligibility criteria in concept plan for Translational 1 RFA."

Twenty-one items are scheduled to be considered at the CIRM directors meeting that begins in only three business days. Background information is now available on only six of those items.

CIRM Contracts with Fleishman PR Firm

The Fleishman-Hillard public relations firm has won a $115,000 contract from the California stem cell agency, according to odwyerpr.com.

The website said Fleishman bested five other firms: Burson-Marsteller, Weber Shandwick, Feinstein Kean, GCI Group and Wundermarx.

Odwyer reported that Ruby Barcklay, a senior vice president in Fleishman's San Francisco office, will be in charge of the account.

The contract includes "media monitoring, leadership media training, opinion leader research in the biotech and business communities, and high-level targeted media placement around the organization's leadership position in the field of stem-cell research funding," according to the report.

The odwyer site specializes in "inside PR news" and is partly free and partly paid.

Fresh Comment

"Anonymous" has posted a comment on the "CIRM Bans" item, stating that this blog is "a balanced and compelling commentary and timely examination of CIRM's operations," among other things. I have no idea who posted it, but, no, I did not pay the person. Re the Larry Ebert comment on the Remcho item, Ebert's comment is now available. I failed to moderate it in a timely fashion.

More Info on CIRM Meeting

The California stem cell agency Tuesday posted background information on one item on its agenda for next week's meeting of its board of directors at Stanford.

The material included: the names of two persons to be appointed as medical ethicists to the Standards Working Group. They are Radhika Rao, a law professor at Hastings College of Law and Dorothy E. Roberts, a law professor at Northwestern University.

Fresh Comments

"Anonymous" has filed a comment agreeing with CIRM's ban on this blog. We have filed a response. Larry Ebert has filed a comment on the "$2 Million Remcho" item.

CIRM Providing Some Early Background Info on Directors Meeting

The California stem cell agency today posted the agenda for its Aug. 12-13 meeting at Stanford, along with some background material.

The background material is a good start on helping the public understand what is to be discussed and acted on by the directors of the $3 billion public enterprise. We are looking forward to more in the next few days.

The background information on one item has clarified what is actually to be discussed when directors take up "consideration of annual report on CIRM contracts and interagency agreements." On Sunday, we speculated that the item could be a proposal to change from quarterly to annual the reporting requirements to directors on outside contracts. In fact, the item appears to be simply the 2007-08 annual report on outside contracting expenditures.

Other background material now available includes:

Draft language for a "grandfathering" provision on stem cell lines. Directors will be asked to authorize a procedure for petitioning them to designate stem cell lines derived before November 2006 as acceptably derived for use in CIRM-funded research.

The names and brief bios of proposed alternate members for the Grant Review Group: Sangeeta N. Bhatia of MIT, Paula Marie Bokesch of Hospira, Inc., Mark Furth of the Wake Forest Baptist Medical Center, Marcie Glicksman of Brigham and Women's Hospital, Kurt Gunter of Hospira, Inc., Paul Kulesa of the Stowers Institute for Medical Research, Hai-Quan Mao of John Hopkins, Todd McDevitt of Georgia Institute of Technoloogy/Emory University, Alan Russell of the University of Pittsburgh and Shuichi Takayama of the University of Michigan.

CIRM Bans California Stem Cell Report

California's $3 billion stem cell agency has had enough!

It has officially banned the California Stem Cell Report from information it circulates to its board of directors and staff. Some employees say staff morale has improved as a result, the agency declares.

Like many other state agencies, CIRM collects news clippings and other information pertinent to its operations and circulates them to a selected audience. For some time (a couple of years, as we understand it), items from this blog were included in the electronic clippings sent to directors. They were also included in clippings sent to grant recipients.

Last year, CIRM unceremoniously dumped the California Stem Cell Report from the clippings to the grant recipients. A while back, we heard scuttlebutt that CIRM's 29 directors no longer had the great pleasure of reading our items, at least courtesy of CIRM. No matter, a mere piffle, we thought. Last week, we heard the report again. So we asked Don Gibbons, CIRM's chief communications officer, whether this "shocking" rumor was correct. Yes, he replied. Gibbons said,

"Before I arrived, all citizen blogs, yours and (patient advocate) Don Reed’s, were dropped from the clips that went to the grantees because it was viewed as too much information they did not care about. They wanted the research news in the rest of the clips. But this required paying extra to create two sets of clips, sending the full clips with the blogs to the board and internal staff. I decided it was not worth the extra cost, and started sending the shorter version to everyone. The service has slipped up and let a couple of Reed’s columns get in, but I have asked them to make sure that does not happen. Eliminating both eliminates bias in the package, and frankly, several in-house staff have said morale has improved since your posts have been removed."

But then we wondered about unordained flackery from various enterprises that has been distributed by CIRM as part of its official "news." Yes, Gibbons said in response to our question; PR releases are picked up from the Ascribe PR network, which specializes in pumping nonprofit-oriented publicity into mainstream newsrooms at as much as $300 a pop. Ascribe's clients include Scripps, Burnham, the University of California, AARP and the National Association of Social Workers.

Musing about all this, we sent off a query to Consumer Watchdog's John M. Simpson, a skilled practitioner of flackery, as well as a former newspaper editor and longtime observer of California stem cell affairs. He replied,

"After reading the California Stem Cell Report daily for more-than-two-and-a-half years, I know how dangerous and subversive it is.

"I only let my wife read it under my direct supervision and would never contemplate allowing my adult children to see it."

Aghast we were. Do you really mean that, John, we promptly emailed him back.

His reponse:

"In this day of Google searches and alerts, I'm hard pressed to understand why anyone would pay anything to have any clips circulated. As for the California Stem Cell Report, I certainly don't agree with all the views expressed there, but I don't understand how anyone interested in CIRM and stem cell research would notoi check it daily. It has become the publication of record on all stem cell related issues in California. If I were CIRM's president I'd make it required daily reading for all employees and would encourage ICOC members to check it frequently."

(Editor's note: We have updated the masthead information at the top of this page to reflect our current status with the world's largest source of funding for human embryonic stem cell research.)

Loans, Eggs, Contracts, Suppliers and $41 Million Top CIRM Agenda Next Week

Directors of the California stem cell agency will meet next week to hand out $41 million to 14 lucky scientists and wrestle with a host of other matters, ranging from the $2.7 million in outside contracts to a proposed $500 million biotech loan program.

Here is a quick look at the topics on the Aug. 12 agenda, which will probably be posted soon on the CIRM website.

Researcher Bonanza -- This a bit of a "do-over" of last year's $85 million faculty award program. That effort was tarnished when five CIRM directors violated the agency's conflict-of-interest policies by writing letters on behalf of applicants from their institutions. CIRM said the letters resulted from an "innocent misunderstanding," but disqualified the 10 applicants involved. No CIRM action was taken against the five directors. The full board decided to provide another grant opportunity, which was also open to applicants other than those disqualified. The latest effort, modified from the first offering, is scheduled for $41 million for 14 winners, with awards up to $2 million a year. CIRM received 55 letters of intent to apply for the grants but has not released the actual number of applications as far as we can determine.

Outside Contracting – Perhaps the most important item in the $13 million operational budget of the stem cell agency is the $2.7 million it spends for outside contracting. That figure is up 50 percent from last year. It is the second largest item in the budget, behind only salaries and benefits. CIRM will have spent more than $2 million for outside legal help by the end of this year and has spent hundreds of thousands for executive searches. In 2005, directors imposed restrictions on outside contracts and required quarterly reporting after they were surprised by published reports about the size and impact of those dealings. On Aug. 12, it appears that directors will be asked to reduce the reporting from quarterly to annual. That would be a mistake. CIRM's board should keep a close eye on the process because of importance of contracting to CIRM and the ticklish issues of overseeing those contractors. Earlier this year, directors had to retroactively approve additional funding for its main outside counsel, Remcho, Johansen, & Purcell of San Leandro, Ca., after work had already been performed. CIRM Chairman Robert Klein also told CIRM directors that Remcho is unique in its abilities, that basically no other firm in the state can perform the work. Thus, Klein reported, the attorney general's office has said the contract does not need to go out for bid. See the Remcho item below for more on Klein's explanation of the relationship between him, Remcho and CIRM and the opinion of the state attorney general. Here is the latest list of outside contracts. Here is the budget for 2007-08.

The $500 Million or So Biotech Loan Program -- The formal agenda topic is "CIRM loan policy." CIRM Chairman Klein earlier this year said he hoped to have the biotech loan program approved this month. But this cryptic agenda item may mean that the board will not be presented this month with the whole package for this ground-breaking and novel effort. See the item below for links to various CIRM documents on the loan proposal. Search this blog on the term "biotech loans" for even more.

Definition of California Supplier – Perhaps hundreds of millions of dollars are at stake in this item. It involves the Prop. 71 requirement that California suppliers be given preference on purchases by CIRM grantees. Legislation is being considered in Sacramento along with separate regulatory language being worked out at CIRM. Here is a link to the latest version of the legislation involved and the transcript of the June CIRM directors meeting at which the topic was discussed briefly. This is an area that has changed swiftly and may well again even before next week's meeting.

Grant Appeals – CIRM is wrestling with the issue of how to handle requests for reconsideration of negative recommendations from the Grant Review Committee. Basically CIRM directors follow the recommendations from reviewers and have been uncomfortable with the few public attempts to override the Grants Committee. Two items could be related to this subject: One deals with RFA applicant policies and the other with creation of a policy for dealing with "extraordinary petitions" to directors for grants. Search this blog on the term "grant appeals" for some background stories, including a proposal by CIRM director Jeff Sheehy.

Egg Matters – Directors will be asked to authorize a procedure for using stem cell lines derived before November 2006 in CIRM-financed research. A subtext of this involves the looming question of egg shortages and cash, although it is not formally on the agenda. CIRM President Alan Trounson has said researchers are "floundering" because they do not have enough eggs. If this subject is important to you, you should be at the meeting.

CIRM is likely to post the agenda for the Aug. 12 meeting at Stanford on Monday, which is six business days ahead of the session. We hope to see additional background material posted early as well. That information would help shed light on exactly what the board will be asked to do next week, beyond the brief listings in the initial version of the agenda.

The $2 Million Remcho-CIRM Connection

The California stem cell agency has a no-bid, $2 million, special relationship with the law firm of Remcho, Johansen, & Purcell of San Leandro, Ca.

The firm has had a contract with CIRM since the agency's earliest days. On May 28, the Governance Subcommittee of CIRM directors was asked to act in a retroactive fashion to increase Remcho's contract for 2007-08 from $250,000 to $415,000 to pay for bills for April, May and June. That amounted to a $165,000 or 66 percent increase in the contract.

Based on the transcript of the meeting, it is not entirely clear who authorized the Remcho work without having the subcommittee first actually approve an increase in the contract. CIRM policies require approval by the governance panel if contracts exceed $250,000.

CIRM Chairman Robert Klein, however, offered the explanation for why the work was needed, which included reviewing requests for applications for grants and work on state bond offerings linked to CIRM.

CIRM contracts with Remcho totalled $1.1 million from January 2005 to July 2007 and are slated for $450,000 this year.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., asked Klein at the meeting whether the Remcho contract would be put out to bid in the future.

Here is the exchange, based on the transcript of the session.

Simpson:

"...(T)his is a substantial legal contract, and it's down as probably going on into the future. Is there an expectation that this would be put out formally for bid?"

Klein:

"This is a contract that is obviously where the expertise is built upon a number of years of research and development on this initiative specifically. And at the time we originally entered into this contract with Remcho back in 2004, I personally went to the (California) attorney general's office and asked, given the specialized knowledge of the Remcho firm had in spending two years on the research and drafting of this with me and four other attorneys that I had in specialized areas, whether we needed to put this to bid.

"The attorney general's position at that time was we did not because of the specialized nature and depth of knowledge of the firm. It would be a huge bill to get any other firm to get up to the level of knowledge about this initiative and the tremendous amount of research that went into all of its development as well as all the public policies that have subsequently been developed."

We have asked CIRM for a copy of the statement from the attorney general's office that supports the ongoing, no-bid arrangement.

Links to CIRM Biotech Loan Info

Here are some links to information related to the CIRM biotech loan proposal.

Biotech terms and policy May 6, 2008, version

PriceWaterhouseCoopers report-(three parts)
Benchmarking analysis
Loan financial model
Loan model scenarios

Transcripts of the Biotech Loan Task Force

Transcript of Finance Subcommittee June 19, 2008, which dealt with size of loans and possible conflicts of interest

Agendas of the Biotech Loan Task Force
The agendas have links to additional documents dealing with the plan.

Patient Advocate Reed's Relentless Effort Against SB1565

Patient advocate Don Reed sent along the following concerning legislation aimed at ensuring affordable access to taxpayer-financed stem cell therapies in California.

He focuses on another element of the bill, which changes voting requirements on research that is not directly related to human embryonic stem cell inquiries.

Reed, vice president of Americans for Cures, has been campaigning vigorously against the bill, SB1565 by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. Many of Reed's efforts surface on the Internet at his blog, stemcellbattles.com. Among other things, Reed is drumming up a letter-writing campaign (better than emails, he says) against the bill.

We checked into his blog recently and saw his account of the hearing last month on SB1565 in the Assembly Appropriations Committee. He noted that CIRM Chairman Robert Klein testified against the measure. It was Klein's first public appearance as chairman of CIRM before a legislative committee. Klein refused to appear before a committee in 2005 and instead launched a national effort among patient advocate groups against those proceedings, triggering a certain amount of unhappiness among some state lawmakers.

The Americans for Cures lobbying group was created by Klein and operates out of the same Palo Alto, Ca., address as his real estate investment banking firm. SB1565 is now on the Assembly floor. If it passes as expected, it will go to the Senate for concurrence in Assembly amendments and then to the governor.

Here is Reed's letter:

"SB 1565 UNCONSTITUTIONAL? Open Letter to the California Assembly and Senate

"Dear Senators and Assembly members:
 
"As the father of a paralyzed young man, (Roman Reed, who inspired the Roman Reed Spinal Cord Injury Research Act, source of America's first state-funded embryonic stem cell research) I strongly oppose Senate Bill 1565 (Kuehl,Runner).
 
"Please be aware that the bill has changed since you first saw it. The bill now contains a poison pill amendment, offered by Senator George Runner, a known opponent of the California stem cell research program. The Runner amendment not only defies the will of the voters, but may violate the California Constitution.
 
"First, here is our stem cell program’s current law, which was enacted by the electorate, and written into the California State Constitution:
 
"'(C) … a high priority shall be placed on funding pluripotent stem cell and progenitor cell research that cannot, or is unlikely to, receive timely or sufficient federal funding…Other research categories…shall not be funded by the institute.'
--Article XXXV of the California Constitution: Section 5, Chapter 3. California Stem Cell Research and Cures Bond Act, Article 1. 125290.60.
 
"As you know, our stem cell program may only be amended  to '…enhance the ability of the institute to further the purposes of…the measure…'—Section 8, Amendments.  
 
"And Senator Runner’s amendment, recently added to SB 1565?
 
"'(D) “Notwithstanding paragraph (C), any other scientific and medical research and technologies and/or any stem cell research proposal not actually funded by the institute under subparagraph (C) may be funded by the institute...'
 
"This turns our program upside down! Proposition 71 was enacted by the voters to give priority to forms of stem cell research not likely to be funded by the federal government.  The Runner amendment removes that priority, and would instead allow precious research dollars to be spent on 'any other scientific and medical technologies'.  That could be almost anything; a bedpan is a piece of medical technology.
 
"How can such a complete reversal be said to “further the purposes” of our stem cell program? Such seeming violations of the Constitution are almost certain to invite legal actions; have we not had enough lawsuits, enough delays?
 
"The original intention of SB 1565, to guarantee access of stem cell therapies to the uninsured, has already been achieved, and without the need for this bill. Bill author Senator Sheila Kuehl, a highly respected legislator, has publicly stated that she and CIRM (California Institute for Regenerative Medicine) are 'on the same page' regarding how low-income residents could receive benefits from CIRM-developed products.
 
"But the Runner amendment could gut the California stem cell program.
 
"Those who know, oppose. SB 1565 is opposed by the Coalition for the Advancement of Medical Research, which is a board of more than 80 medical, educational, and disease advocacy groups: as well as every other stem cell research support group which has taken a position on the issue.
 
"On behalf of every California family with a loved one suffering from chronic disease or disability, I urge your 'NO' vote on Senate Bill 1565, when it comes before you for concurrence.
 
"Thank you.
 
"Don C. Reed
Co-chair, Californians for Cures
Sponsor, Roman Reed Spinal Cord Injury Research Act
Vice President, Public Policy, Americans for Cures"

Giving Credit at CIRM

CIRM Communications Chief Don Gibbons pointed out today that Amy Adams did all the hard work to bring together the useful grant information mentioned in the "CIRM Website Improves" item. A good job indeed.

Adams is communications manager at CIRM and works for Gibbons. We should also mention Alan Trounson, CIRM's president, who last January identified web site improvement as one of his priorities.

While we are on this subject, today we were foraging a bit and checked into the CIRM regulations page. We can't say for sure whether it has changed much, but it is a useful compilation of all CIRM's regulations and their justifications, including links. This is the page where the public can also see the timelines on proposed regulations and learn how to make comments during the official process.

Fresh Comment

Larry Ebert has filed a comment on the "Eggs and Money" item.

CIRM Website Improves; More Info on Where The Money Goes

The California stem cell agency is slowly beefing up and improving its web site, posting additional information that is helpful to folks seeking to know more about how $3 billion in taxpayer funds are being spent.

One of the features added to the site recently is a list of all 206 grants (worth $554 million), their subject areas, institutions and the names of the principal investigators with links to the summary of the proposal by reviewers.

CIRM has also posted a ranking of institutions by the dollar value of CIRM grants that they have received. That list includes the type of grants awarded to each institution and the total dollars in each grant round.

Much, if not all, of this information was previously available on the CIRM website. But it took a lot of digging to ferret it out. The material is basic information, but it takes considerable work and care to compile it in a readily accessible format, not to mention updating it as warranted. And as we mentioned earlier, CIRM has also begun an "alert" service that provides automatic email notification to interested persons about a variety of events and information.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., recently singled out the list of all 206 grants for praise, calling the summary "user friendly and handy."

Don Gibbons is the chief communications officer for CIRM and oversees the content on the website. He is to be commended for pulling all this together. It is a valuable resource for the public and interested parties. We look forward to other features that he may add to the web site.

You can sign up for the CIRM alerts by going to its home page and clicking on the sign-up button.

The Associated Press Digs Into Eggs, Money and Stem Cell Research

The Human Egg Debate just racheted up a notch.

Generally confined to scientific journals and websites like the California Stem Cell Report, the issue of scientists paying for eggs for human embryonic stem cell research today clattered onto a broader stage in a thorough-going piece by The Associated Press. The international news service distributes its stories to virtually every newspaper, radio and television station in the country.

Marcus Wohlsen wrote the article out of San Francisco. It began,

"Facing a human egg shortage they say is preventing medical breakthroughs, scientists and biotech entrepreneurs are pushing the country's top funders of stem cell research to rethink rules that prohibit paying women for eggs."

The California stem cell agency was mentioned in the second paragraph. Stemagen, a San Diego stem cell firm, was mentioned in the sixth. Alan Trounson, CIRM's president, Harvard's Kevin Eggan, Cascade LifeSciences, also of San Diego, and the Center for Genetics and Society of Oakland, Ca., were all included.

Sam Wood(pictured), chief executive of Stemagen, said that bans on payments for eggs have kept researchers from making advances that could save lives.

He was quoted as saying,

"You need to have enough eggs to make this thing work, and when you have enough eggs it does work."

"If these guidelines weren't in place, we'd already have many (stem cell) lines and be much closer to a treatment for devastating illnesses for which these are so well suited."

The AP story continued:

"As the country's largest funder of stem cell research by far, California's policy sets the pace for biotech firms and academic researchers nationwide. National guidelines advising against egg payments were developed to ensure any innovations would remain eligible for California funds; any changes to the state's policy would likely have an immediate ripple effect.

"California could also face increasing competition for business and scientific talent as New York prepares guidelines for its own $600 million stem cell research program. A draft report released by the New York program's planning committee said the state may allow payment for eggs."

But Wohlsen quoted Marcy Darnvosky of the Center for Genetics and Society as saying,

"Do we really want to put women at risk to provide raw materials for research a lot of scientists say really isn't the way to go?"

The references to Cascade, Trounson and Eggan all were to events chronicled earlier on the California Stem Cell Report, including the June meeting of CIRM's directors and the February meeting of the CIRM Standards Working Group.

The AP story pulled all of it together for general readers across the nation and perhaps abroad. Wohlsen's article will also attract the attention of editors around the country who may well commission locally written pieces and possibly editorials. It might even trigger a television news story or two.

Fresh Comment

Don Thornton has filed a comment on the correction item below.

Correction

The "Klein Confirms Resignation" item incorrectly identified John M. Simpson as Robert Simpson.

This is not the first time I have had made that mistake. The reasons go back to the early 1970s when I covered the California State Capitol for United Press International. Ronald Reagan was then governor. But he was not the only fixture under the dome. An elderly gentleman by the name of Robert Simpson also prowled the hallowed halls of state government. He was upset about some quite legitimate issue involving him personally, and the state system that did it to him. Unfortunately, the details are lost to memory. Even Google can't turn them up.

Robert Simpson meandered about the Capitol with his walker on nearly a daily basis, carrying hand-lettered signs with red characters proclaiming his grievances. His most memorable slogan was: "Reagan is a bastard!" It came at a time when such a public denunciation was still shocking. From time to time, Simpson was arrested by state police or Reagan's security forces and carted off to the local hoosegow. Undeterred he would pop up the next day invigorated by the experience.

I interviewed Robert Simpson on several occasions. His dentures did not fit well, and his enunciation was poor. Sometimes, spittle would fly and land on those nearby. The stories I wrote about him did little to solve his problems with the state of California. He was banging futilely against the state's bureaucracy. However, he relished the fight and the attention.

A couple of years later, a new reporter arrived in the Sacramento UPI bureau. (I taught him everything he knows.) Appropriately, he re-discovered Simpson and wrote about him again, pushing those stories into national prominence. Mr. Simpson, as we called him, delighted once more in the attention but his disputes were never settled to his satisfaction.

My recollection is that Mr. Simpson's health, never the best, declined. Members of his family came from out of town to assist. His obituaries were fulsome and replete with fond references to Mr. Simpson's good humor, despite his belief that he was never treated fairly by the state of California and the governor who portrayed so many amiable characters on the silver screen.

And that is why my fingers – to this day -- sometimes type in Robert Simpson's name instead that of John M. Simpson.

CIRM Revising Rules on Pre-2006 Cell Lines

The CIRM Standards Working Group had a plateful last week, dealing with the question of whether it can finance human embryonic stem cell research involving cell lines that were derived prior to CIRM regulations.

The short answer is provided by John M. Simpson, stem cell project director of the Consumer Watchdog group, who attended the meeting. He wrote on his group's blog:

"A stem cell line may be deemed acceptably derived before November 2006 if the following criteria are met:

"Informed consent from woman or couple in IVF (and no indication that original donor would not consent for research).

"Approval of the donation protocol by an Institutional Review Board.

"Compliance with prevailing ethical and legal standards in place at the time of derivation in the jurisdiction where the derivation was carried out.

"The process to determine if the criteria had been met would begin with a request to CIRM. The staff would review the request and make a recommendation to the oversight board, the Independent Citizens Oversight Committee.  The review would have to include consideration of the scientific significance of the stem cell line.  The ICOC would consider the request in a public meeting after publicly posting it."

The Standards Working Group did not have a quorum so its "plan" will go to directors, presumably at their August meeting, as representing the "sense of the group" but without a formal recommendation. Such a practice is commonplace with CIRM since it has perennial problems with securing quorums at meetings.

If you see problems with the CIRM proposal or support it, now is the time to send something along to the agency.

Klein Confirms Resignation, Lobbying Connections Remain

The chairman of the California stem cell agency has personally confirmed that he has resigned as head of his personal stem cell lobbying group, Americans for Cures, which has been nearly silent on the subject since July 14.

Robert Klein's exit as president of the group came after it excoriated an influential California lawmaker on a widely read political blog, the Daily Kos.

Second-hand reports surfaced (the first on July 14) that he was resigning as president of the group, which shares the same address as his real estate investment firm as well as the same fax number.

Since then, Americans for Cures has not responded to repeated requests asking for confirmation of Klein's departure. Nor did Klein tell state Sen. Sheila Kuehl, object of the attack, that he was resigning, as he had said he would.

But Robert M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., encountered Klein last week at the meeting of the CIRM Standards Working Group. Simpson said,

"I asked Klein what his status with the group was when I saw him on Friday. He said that he had resigned the night he learned about the Kos article and came back from vacation.

"I told him that his name was still on the website. He said he'd call them to have it removed."

Since then, the reference to Klein as president has been removed from the website by Americans for Cures, along with a list of all its directors.

On July 24, we wrote about Klein's failure to announce his resignation, commenting that the initial, second-hand reports may have amounted to some sort of trial balloon that Klein hoped would trigger calls for him to remain as head of Americans for Cures.

Don Gibbons, chief communications officer for CIRM, today volunteered the following reaction to our trial balloon comment,

"The Americans for Cures web site has been corrected regarding the president. That theory you put forth on the issue goes beyond speculative paranoia."

With his resignation, Klein has recognized that his connections with Americans for Cures are not compatible with his role as a public servant and chairman of an agency that is giving away $3 billion of California taxpayer's money.

Klein's resignation, however, is less than a half-measure and does not even well serve his own best interests. If it is an attempt to distance himself from the organization, it falls far short. If he continues to serve on the board of directors of the lobbying group, if the group continues to share Klein's office fax number and address, if he continues to control hiring and policy and generate financing for the group, Klein remains accountable for whatever the group does. Particularly for any actions that do not coincide with the best interests of the people of California or CIRM.

Klein volunteered for his role at CIRM and has not been paid for his work for nearly three years, which is all to his credit. Would that more California businessmen and women donate their time and energy to help solve some of society's difficult problems.

But when Klein accepted his job as a public servant, other activities became incompatible. One of those is directing a lobbying group that operates in the same area as CIRM.

As we reported earlier, Klein's dual roles represent an inherent conflict of interest. It is as if a high level executive with the California Medical Association also served on the state Medical Board. It is impossible to know whether their official actions represent their own views or the views of the special interest group.

CIRM Confirms Departure of General Counsel

The California stem cell agency today confirmed that Tamar Pachter is leaving her post (see item below) as general counsel of the $3 billion enterprise.

Her Aug. 15 departure pretty much finishes off the senior management team assembled by former President Zach Hall, who retired in the spring of 2007. The top senior executives now in place were brought in after Hall left and after Chairman Robert Klein recruited Alan Trounson as president.

Under Klein's leadership, CIRM has also been reorganized to shift more staff and responsibility to the chairman's office, undoing directors' changes in 2007 that stripped Klein's office of six positions.

Klein and Hall butted heads more than once, mostly in private, but in public put the best face on their relationship. Conflicts emerged partly because of the overlapping roles provided for president and chairman in Prop. 71. Under normal state and business practices those roles could be clarified by an organization's board of directors, but Prop. 71 locks them into state law, making them virtually impossible to change. The differences between the men, however, went beyond the CIRM structure, reflecting their divergent personalities, professional background and philosophies.

In response to a query from the California Stem Cell Report, Don Gibbons, chief communications officer for CIRM, confirmed Pachter's resignation. He said she would return to the state Department of Justice, where she served as a deputy attorney general. It was in that position that she argued and won the case that threatened to put CIRM out of business.

CIRM's Chief Counsel Quits

The attorney who successfully defended the California stem cell agency against challenges to its existence has resigned as CIRM general counsel after only 16 months on the job, according to a well-informed source.

One longtime observer of CIRM affairs characterized the reported resignation of Tamar Pachter(pictured) as a "troubling development" that reflects poorly on CIRM Chairman Robert Klein.

Pachter could not be reached for comment on her decision to leave her $225,000-a-year post. CIRM has not responded to our queries on her resignation.

Pachter is at least the 17th employee to leave CIRM since it began work in 2005. The agency has only slightly more than 30 employees with plans to reach 39 by the end of this fiscal year.

Only last December Pachter received a 41 percent pay increase, up from the $160,000 that she was hired at in March 2007.

Rumblings have surfaced, however, that Pachter was not happy. One likely issue is the fragmented legal approach at CIRM. Typically a general counsel oversees all the legal operations of a state agency or business. However, that was clearly not the case at CIRM.

The agency has retained outside counsel, Remcho, Johansen & Purcell of San Leandro, Ca., since 2005 at a cost exceeding $1 million. CIRM has at least three other attorneys, not including Pachter and Chairman Klein, who wrote much of Prop. 71, the ballot measure that created the agency. None of those attorneys reported to Pachter, according to CIRM's organizational chart. Instead they come under Klein.

CIRM plans to hire two more attorneys this year. Neither of them is linked directly to the general counsel's office. CIRM also has received legal assistance from the state Department of Justice.

Frequently Pachter and James Harrison, Remcho's main CIRM representative, would attend the same CIRM public meetings. Often, Klein deferred to Harrison at those sessions. The Harrison/Remcho contract is due to be renewed on Wednesday for $450,000 for 2008-09 at rates up to $350 an hour.

We asked John M. Simpson, stem cell project director for the Consumer Watchdog group of Santa Monica, Ca., for his thoughts on Pachter's departure. Simpson recently commented on how CIRM's top management seems to be an "old boys' club."

Simpson said,

"If Tamar Pachter has resigned, it is a troubling development. CIRM has been plagued with high turnover and much of the blame for this rests with the management style of Chairman Bob Klein. The agency has lurched too frequently in different directions; what's needed is a steady hand at the helm that allows the routine to become routine."

When Pachter was hired out of a pool of nearly 100 applicants, CIRM hailed her "impeccable legal credentials" and described her as a "superb litigator."

Bee 'Flabbergasted' by Klein's Actions

The Sacramento Bee has not been pleased with Robert Klein virtually since he became chairman of the $3 billion California stem cell agency more than three years ago.

Earlier this week, the newspaper fired off another editorial lambasting Klein, this time accusing of him of misusing his office.

The case in point involves Klein's personal stem cell lobbying group, Americans for Cures, which recently publicly excoriated an offending state legislator in a posting on a widely read, national political blog.

The Bee wrote,

"Through his connections with the governor and other state leaders, Klein effectively directs who is appointed to the institute's 29-member oversight board, which includes university deans dependent on research funds that Klein controls.

"That should be enough power for any one public official. But not for Klein.

"Up until last week, Klein also served as president of Americans for Cures, an advocacy group that works out of offices he owns in Palo Alto. That linkage provides Klein with a nongovernmental agent with which to go after his opponents and further his institutional power."

The Bee continued:

"Government officials shouldn't be affiliated with special interest groups that lobby on issues that affect their agencies. After three years, it remains flabbergasting that Klein doesn't recognize that conflict and the injury it causes to the state's stem cell program. Even more curious is why the institute's 'oversight' board continues to condone it."

The Bee's editorial was written before the disclosure that Klein plans to spend 88 days traveling out of state this fiscal year at taxpayer expense. We are certain that the newspaper would have been even more exercised if that had been known at the time the editorial was written.

As far as Klein's reported resignation as president of Americans for Cures, so far no official announcement has been forthcoming. One report had it that the resignation would be announced after he told Sen. Sheila Kuehl, the object of his group's ire, about it. But her office said that Klein did not mention resigning in their conversation following the offending Internet post.

The delay in announcing his resignation may indicate that the earlier resignation reports amounted to something of a trial balloon effort by Klein in which Klein expected supporters to rally around him. Meanwhile, he is still listed as president on the Americans for Cures website.

Lockyer Names Quint to CIRM Directorate

The California stem cell agency has a new member on its board of directors, a cardiologist from San Jose who once treated former state lawmaker John Vasconcellos.

The new member of the CIRM Oversight Committee is Robert Quint, who was appointed to the post by state Treasurer Bill Lockyer.

A spokesman for Lockyer said Vasconcellos had recommended Quint. "We were highly impressed with Quint's resume, and the man himself, and Lockyer decided he was the person for the job." the spokesman said. Lockyer and Vasconcellos, both Democrats, served in the state legislature together.

Quint replaces Janet Wright, also a cardiologist, on the 29-member board. Wright left earlier this year to take a job in Washington, D.C., with the American College of Cardiology.

Quint has operated his own cardiology practice in San Jose since 1980. Lockyer's office said,

"He has helped develop pioneering diagnostic and treatment techniques for arteriosclerotic heart disease, including coronary angiography and angioplasty."

We asked Lockyer's office whether Quint had been recommended by CIRM Chairman Robert Klein. Spokesman Tom Dresslar replied,

"Former state legislator John Vasconcellos did.  He and Lockyer go way back."

One vacancy remains on the CIRM board of directors.

CIRM Mulls Kuehl Legislation Once Again, Supplier Proposal Also on Table

A directors subcommittee of the California stem cell agency will discuss on Thursday their opposition to legislation aimed at ensuring affordable access to state-financed stem cell therapies.

The bill is only two steps away from being sent to the governor's desk. No lawmaker has voted against the measure, SB 1565 by state Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley. It is now on the the Assembly floor. If it wins approval as expected, it will go to the Senate for concurrence in Assembly amendments and then to the governor.

CIRM has officially opposed the measure, and it is not clear what its Legislative Subcommittee might do at the Thursday afternoon meeting, short of renewing the agency's opposition. Interested parties can participate or listen in on the meeting at public teleconference locations throughout the state, including San Francisco, Elk Grove, Irvine, Healdsburg, Sacramento and Palo Alto.

The meeting comes as BioRegion News is carrying a lengthy look at the bill, its support and opposition. Written by Alex Philippidis, the piece quotes Kuehl as saying regarding CIRM,

"They don’t intend to remove their opposition. They simply want more, and more, and more amendments, because they want the bill to go away. But the bill is not going away."

Also up for discussion at the Thursday meeting is the California supplier bill, AB 2381 by Assemblyman Gene Mullin, D-San Mateo. That bill would define California supplier for the purposes of providing a preference to such businesses as required by Prop. 71.

Currently the bill is in the Senate Appropriations Committee and is scheduled for a hearing Aug. 4. CIRM is also proceeding with its own regulatory definition of California supplier. The legislation has been the subject of considerable negotiation. Movement by CIRM may well come at the Thursday meeting. Here is a link to the latest amended version of the bill, although it may not reflect more current drafts that are not available on the Internet.

Fresh Comments

Larry Ebert has posted a comment on the "group-think" item. "Anonymous" has filed a comment on the "WARF whacked" item.

The Perils of Group-Think at CIRM

Is the California stem cell agency dominated by an Old Boys Club that is shy on experience in running a grant program totalling a half-billion dollars?

John M. Simpson, stem cell project director of Consumer Watchdog of Santa Monica, Ca., thinks so.

Simpson, who describes himself as a "fat, old white guy," says he doesn't have anything against such persons. But he warns about the perils of group-think when the top execs are cut from the same general mold.

Only one woman and no minorities hold top management positions at CIRM, which Simpson lists as chairman, vice chairman, president, vice president, chief scientific officer and chief communications officer.

Writing on his organization's blog, Simpson sees the hiring of John A. Robson of McGill as part of the influence of CIRM's old boys. Simpson cites the role of Richard Murphy, former CIRM director, former interim president and ongoing consultant, in recruiting Robson. Murphy also once worked at McGill.

Simpson also notes that former CIRM acting president Lori Hoffman had a falling out with Chairman Robert Klein last year and was "pushed out."

Simpson writes that with Zach Hall as president and Arlene Chiu as chief scientific officer, CIRM "had extensive experience on the grant-making and management side of the equation by virtue of their time at the National Institutes of Health. They knew something about holding grantees accountable."

Simpson continues,

"The Old Boys Club members' experience has been on the grant-receiving side -- and most of that in academia.  Certainly some of the top executives at an agency charged with handing out $3 billion in scientific grants should have experience on the grant-making side. It's almost as if the henhouse is being taken over by the foxes."

Simpson concludes:

"I fear the Old Boys Club is letting visions of playing on the international stage distract them from what is really CIRM's charge: Funding vital research and finding cures in California.  The real danger of a having a management team that looks alike is that team members will think alike. Nobody will stand up and say, 'Wait a minute; just what are we doing here and why?'"

Fresh Comment

Marcy Darnovsky of the Center for Genetics and Society in Oakland, Ca., has filed a comment on the "no egg shortage" item.

Fresh Comments

Larry Ebert has posted a comment on "WARF Whacked Again."

Angsuman Chakraborty has posted a comment on "Stem Cell Globe-Trotting."

A Re-Look at Friday's Egg Meeting

The California stem cell agency has taken issue with the way we have framed this coming Friday's meeting dealing with human eggs.

It is not really about availability, cost and prices, says CIRM. But rather about stem cell lines and embryos created through IVF treatments and their possible use in CIRM-financed research.

Geoff Lomax, senior officer for the Standards Working Group, said,

"You have got this one completely wrong and framed the meeting in a sensational and inflammatory way which does a disservice to thoughtful policy deliberations."

Lomax prepared the briefing paper – called "Use of Embryos Created for Reproductive Purposes with Paid Gametes" – for use at the Standards meeting later this week.

When we read it, we took a broader perspective, one that concerned the general availability of eggs for research and the economics behind their apparent scarcity.

But first CIRM must deal with the information Lomax presents in his background material as well that which will be brought to the table by others.

He wrote:

"Nationally, the CIRM policy deviates from other jurisdictions that have developed policies to advance stem cell research. This deviation has raised concerns over the ability of CIRM researchers to utilize materials derived under other jurisdictional policies or the National Academies Guidelines."

The issue of the use of human eggs is freighted with emotional and political baggage, plenty of which will surface eventually. But meantime, Lomax is trying to lay the groundwork for a straightforward consideration of practical issues that need attention sooner rather than later.

San Diego Researchers Say No Shortage of Human Eggs

Jeff Sheehy, a member of the board of directors of the California stem cell agency, has brought to the human egg debate a new entry that appears to fly in the face of assertions that scientists cannot get enough eggs for their human embryonic stem cell research.

His comments and information come as the CIRM Standards Working Group plans to dig into the topic again this Friday during a public hearing in Los Angeles. The issue of egg availability, however, goes well beyond California, reaching out to such places as the United Kingdom, where discounted IVF services are being offered to generate eggs for research.

Sheehy, also a member of the Standards Working Group, pointed to work being done by Cascade LifeSciences in San Diego and others to show that the egg shortage concerns of CIRM President Alan Trounson and Harvard's Kevin Eggan may be overstated.

Sheehy's starting point is a letter for reconsideration of Cascade's rejected application for a CIRM grant. Cascade's letter, which can be found here on the California Stem Cell Report, stated that the firm was collaborating with David Smotrich of the La Jolla IVF clinic to obtain eggs. Cascade said that the clinic had a "list of young and healthy volunteers who desire to donate oocytes specifically for this SCNT project. All these donors were pre-tested and demonstrated a high oocyte production (20-25 oocytes per cycle) in response to homornal stimulation."

Last week Sheehy queried Ken Woolcott, who wrote the reconsideration request, about the availability of eggs, which Sheehy recalled as being 100 a year. Sheehy also asked whether they were obtained under circumstances that would make them available for use by CIRM grantees i.e. proper consent, no payment outside of CIRM policy, etc.

In response, Woolcott, Cascade's chief business officer, emailed Sheehy that he checked with Cascade's primary investigator, Dr. Sophia Khaldoyanidi, as well as Smotrich, head of the collaborating La Jolla IVF clinic. Woolcott replied,

"Dr. Smotrich confirmed that the oocyte donors are only reimbursed for their time and medical care expenses.   These donors are not IVF patients that receive discounts or are paid for their eggs.  They tend to be donors that desire to enhance medical research in the Stem Cell  area, are younger and have a track record of high oocyte quality and productivity. 

"I believe that this is consistent with the draft guidelines prepared by CIRM and is consistent with the law in California.    More importantly, any work in this area would be subject to IRB approval."

Sheehy said that Woolcott's information is "very important" if it "confirms that at least one investigator in California is able to obtain sufficient oocytes to conduct research within the confines of CIRM's ethical standards and the provisions of Prop. 71 and SB 1260(the law that deals with non-CIRM funded hESC research)."

But the devil may well be in the details. In this case, does the La Jolla clinic's definition of reimbursement for "time and medical care expenses" match that of CIRM's?

A Critical Look at CIRM's Stem Cell Globe-Trotting

The Consumer Watchdog group is taking a dim view of the travel plans of the top executives of the California stem cell agency, describing as "bafflegab" the justification for spending much of the $558,000 in what CIRM describes as its "other travel" budget.

John M. Simpson, stem cell project director for the non-profit advocacy group, made his comments on his organization's blog. They were based on previously undisclosed documents that he requested from CIRM.

Among other things, the CIRM documents showed that its chairman, Bob Klein(pictured), is scheduled to be outside of California for 88 days at state expense in 2008-09. That does not include his travel within California, such as his trip today to Santa Barbara.

Chief Science Office Marie Csete will be out of California 75 days, CIRM President Alan Trounson 68 days, Chief Communications Officer Don Gibbons 32 days. All of which amounts to a 287 percent increase (in terms of dollars) in "other travel" by CIRM officials.

China, Japan, the United Arab Emirates, Israel, the United Kingdom, Sweden, The Netherlands, France, Korea, Australia, Italy, South Africa and Canada are among the destinations.

To a CIRM travel justification that said in part that some of the trips were necessary "in order to have an integrated picture of state of the art and forward-looking research agendas," Simpson retorted, "bafflegab."

He continued,

"After crunching the numbers I checked with some scientists.  All agreed there is a need for the hard-working science staff to attend some conferences to stay abreast of the latest developments. Perhaps one or two a year, suggested one.

"Another scientist reported traveling 4-5 days a month to to give seminars, attend meetings and review grants and then said about CIRM's travel plans:

"'Is the travel necessary? No.  Useful for CIRM? Probably not very much.  Good for Bob and Alan?  Absolutely.'

"Voters passed Proposition 71 because they wanted to pay for vital stem cell research in California that the federal government would not fund.  They did not intend to send Bob Klein around the world as a stem cell research advocate."

Still undisclosed, as far as we can tell, are travel expenses that are not classified as "other travel."

Simpson has posted the documents in question on his website. Links to them are contained in his blog.

CIRM Reviews the Business of Human Eggs

One week from today, the California stem cell agency is going to dig into the hot topic of human eggs – how many can scientists can get and their cost.

To its credit, the agency has posted background material on the subject well in advance of the July 25 meeting of its Standards Working Group in Los Angeles. Providing the material early is a refreshing change from CIRM's recent dilatory practices. The agency is to be commended.

The egg meeting comes in the wake of complaints earlier this year by researchers and CIRM President Alan Trounson that human eggs were not to be had in sufficient quantities for research. Kevin Eggan(pictured) of Harvard, a member of the Standards group, said that he and his colleagues had spent $100,000 advertising for human egg donors with little success.

The problem is that California and other states bar compensation for eggs for research. But handsome payments -- $15,000 and even more -- are made by IVF clinics for the same egg donation process. So most women take the cash.

Eggan made his comments last February. The ensuing discussion set in motion a review of CIRM policies dealing with compensation of donors. The issue also came up briefly last month at the meeting of the CIRM board of directors.

Trounson said scientists are having a "terrible time" securing eggs. He declared,

"It's all because there's no partnershipping arrangements or because they're using very few oocyte material. They're now trying to use cattle eggs, other species. They're floundering."

CIRM has prepared a draft briefing paper dealing with the egg issue. The agency has not completed all of its work on the subject, but it is surveying funding institutions, interviewing scientists and others and determining whether specific cell lines are not being used by CIRM grantees.

The briefing paper lists the following policy questions.

"Should CIRM funded researchers be able to use 'outside' hESC lines if they are derived from IVF-embryos created with paid gametes?

"Should CIRM funded researchers be able to utilize hESC lines derived from IVF-embryos created with paid gametes under an 'authorized authority'?

"Should CIRM funded researchers be be able to utilize IVF-embryos created with
paid gametes to derive new lines?"

Also prepared for next week's meeting is a briefing paper on uses of cell lines derived prior to CIRM regulations.

WARF Whacked Again

The latest chapter in the WARF stem cell patent saga opened today with the filing of an appeal by two consumer groups and a statement from California researcher Jeanne Loring of the Scripps Institute. She said,

"It's not just scientists that are affected by the patents. Patients and their families know that WARF’s iron-fisted control of stem cells is slowing life-saving research."

Consumer Watchdog of Santa Monica, Ca., and the Public Patent Foundation in New York City announced the filing of the appeal. The issue is not likely to be resolved for years, although John M. Simpson of Consumer Watchdog said WARF has already relaxed its licensing requirements in the wake of the patent challenge.

Simpson said,

"WARF executives were acting like arrogant bullies blinded by dollar signs. Our challenge has engendered a more co-operative stance towards the stem cell research community on their part."

Kindling the Flame in Goleta: Thomson, Klein Part of Gaucho Show

California's Robert Klein will share the stage with Wisconsin's Jamie Thomson Friday at the University of California, Santa Barbara, which has lured the renown researcher to its seaside campus with a $1 million package, including a new lab.

Klein, of course, is both the chairman of California's $3 billion stem cell agency and still officially president of his own private stem cell lobbying group, Americans for Cures. (No announcement has been forthcoming from the group confirming his reported resignation in the wake of its vitriolic attack on an influential state legislator.)

Klein and Thomson (pictured) will appear as part of a town hall event to discuss the state of stem cell research. The roundtable will also feature Congresswoman Lois Capps, a former nursing instructor, Gaucho (as UCSB denizens are known) alum and Wisconsin native.

CIRM has had a huge impact in California stem cell circles in the last 3 ½ years, but UC Santa Barbara might well be a poster child for what the agency has achieved.

Human embryonic stem cell research hardly existed on the campus (pictured) prior to 2005, the first full year for the California's research effort. But with a strong push from professor Dennis Clegg, now co-director of the UCSB Center for Stem Cell Biology and Engineering, the school scored in the first round of grants approved by CIRM. Today it has $6.7 million in stem cell research and lab construction funds from the California stem cell agency and another $3 million from one of the founders of Amgen. And it succeeded in drawing Thomson into the state on a part-time basis.

Thomson, whose lab is located in the UCSB California NanoSystems Institute, says,

"I am attracted by UCSB's strengths in materials science, instrumentation, and by the availability of marine model organisms for comparative studies."

Of course, UCSB's $6.7 million in CIRM funding is eclipsed by the $91 million given by CIRM to Stanford and the $69 million to UC San Francisco. But those campuses can generate buckets of money even without the state cash.

The Santa Barbara university has this to say about its fledgling stem cell effort:

"UCSB is well positioned to make unique, significant contributions in stem cell research, with extraordinary enabling technologies in biomaterials, systems biology, nanotechnology, micro-processing and bioengineering, all of which are synergistic with fundamental biomedical research efforts. Our approaches are uniquely distinct from those at California medical schools, with our emphasis on basic biological questions and engineering challenges related to stem cell research."

What CIRM has done is kindle a flame in Goleta (the actual location of UCSB). The hope is that the UCSB effort will grow and prosper, bringing new initiatives and insights into development of possible stem therapies.

Stem Cell Affordability Bill Marches Towards Schwarzenegger

Legislation aimed at ensuring affordable access to any therapies developed as the result of California's $3 billion stem cell research program today easily cleared its final committee hurdle and appears likely to wind up on the desk of Gov. Arnold Schwarzenegger.

The measure (SB 1565) by Sens. Sheila Kuehl, D-Santa Monica, and George Runner, R-Antelope Valley, was sent to the Assembly floor by the Assembly Appropriations Committee. Presuming it wins Assembly approval, it will go back to the Senate for concurrence in Assembly amendments. No lawmaker has voted against the bill, nor did any today although the final official vote is not yet available.

The bill has faced sometimes vitriolic opposition, particularly from the private lobbying group of the chairman of the state's stem cell research effort, Robert Klein. Americans for Cures lambasted Kuehl as "ignorant" and "craven" in a posting on the Daily Kos, a political blog with about 1 million page views a day.

Americans for Cures, which operates out of the same address as Klein's real estate investment banking firm, later apologized and asked that the offending item be removed. Klein said he did not know about the item. He is reportedly resigning as president of Americans for Cures, but it is not clear whether he will sever all ties or whether the organization will move from his offices.

Klein's connection to the lobbying group, which is an offshoot of the Prop. 71 campaign organization, has long triggered criticism because of concerns about conflicting interests.

One commentator, who must remain anonymous, told the California Stem Cell Report today:

"I would say it's an inherent conflict to be an officer of any kind of 'Cures,' while being on the ICOC (the board of directors of the stem cell agency). It would be like a physician who is a high level officer in the California Medical Association being on the (state) Medical Board. One would never know whether their official actions represented their own views or the views of the CMA."

Americans for Cures has not yet confirmed that Klein is resigning. (Shortly after this item was posted, we saw a report on the Niche stem cell blog of Nature magazine saying that Americans said Klein has resigned but will remain on the lobbying group's board, which probably means that it will continue to be housed at Klein's offices.)

The next lobbying target for CIRM and the stem cell activists is the governor, who can veto the legislation and who has been more than receptive towards the stem cell agency's efforts.

Here is a link to the latest legislative staff analysis of the bill.

CGS Says CIRM Legislation is 'Gentle'

The Center for Genetics and Society says the stem cell measure now before the California legislature would only "gently alter" affairs at the state's $3 billion stem cell research effort.

The group's comments came as as more activity surfaced concerning the measure, SB 1565, which comes before the Assembly Appropriations Committee today. It has sailed through the legislature without a dissenting vote despite fierce – sometimes scathing – opposition from stem cell advocates.

Commenting on the center's blog, Biopolitical Times, Jesse Reynolds said that CIRM's board of directors is engaging in "histrionics" and opposes the measure even though it would give them more flexibility.

Reynolds, who wrote presciently nearly four years ago about some of the problems that have surfaced at CIRM, commented Tuesday that the agency

"... can fund any biomedical research if a two-thirds supermajority of its grants review working group approves. The current Senate bill would lower that bar to a simple majority.

"This would not restrict the CIRM in any way. If anything, the bill simply gives the CIRM more flexibility. Considering that the grants working group generally operates by consensus, that the governing board must approve all grants, and that the CIRM currently generously supports non-embryonic stem cell research, the amendment would have zero practical impact.

"Nevertheless, the board worked itself into histrionics over any concession to the development of alternatives."

Reynolds' "gently alter" remark appeared in a related posting that said that Klein's apparent resignation as president of his lobbying group, Americans for Cures, was long overdue. A CIRM spokesman said on Monday that Klein had resigned, but deferred any further comment to Americans for Cures. That group has not responded to repeated requests for confirmation of the Klein resignation.

Reynolds' postings came as patient advocate Don Reed, vice president of Americans for Cures (the private lobbying group of CIRM Chairman Robert Klein), wrote on the influential Daily Kos political blog about the measure. He urged readers to lobby against the bill and send "hard copy" letters to the governor, asking him to veto the proposal.

Also, James Kovach, president of the Buck Institute in Novato, Ca., sent a letter to a member of the Assembly Appropriations Committee, declaring the organization's opposition to the Kuehl bill. He said it would disrupt embryonic stem cell research. The full text of the letter follows in a separate item below.

Text of Buck Institute Letter on SB 1565

Here is the text of a July 15 letter to Assemblyman Jared Huffman, a member of the Assembly Appropriations Committee, from the Buck Institute, opposing legislation aimed at ensuring affordable access to state-financed stem cell therapies.

Dear Assemblyman Huffman,
 
Thank you for the opportunity to comment on SB 1565.  We understand that SB 1565 will be heard before the Appropriations Committee on Wednesday, July 16th, at the Sacramento Capitol. As this will be the last full committee hearing on SB 1565, before it goes to the Assembly floor, on behalf of the Buck Institute I would like to provide you with our view of this proposed bill.
 
We strongly oppose SB 1565.  Our reading of the proposed changes led us to conclude that the changes are unnecessary and, if adopted, would likely have several negative consequences.  Our primary objections are set forth below:
 
The scientific review committees are represented by specialists in stem cell research.   They are already tasked with reviewing many excellent applications for funding of research in the stem cell arena.  It is important work done on often grueling schedules and any requests to evaluate “vitally important research” not associated with stem cell and/or stem cell related work will distract their attention from the work they were specifically chosen to perform.  We believe the purpose of Proposition 71 will be altered by the amendment and moreover, alter the mission of the scientific review committees.
 We believe the proposed amendment will disrupt the conduct of human embryonic stem cell research as set forth in Proposition 71, the Constitution of the State of California and the will of a majority of the voters in California.  If passed, the proposed amendment would alter the will of the people without their consent. 
The potential change in the direction of stem cell research funding would come at a crucial juncture in the development of the CIRM.  The development of the CIRM has been guided by the principles embodied in Proposition 71 and is just beginning to apply its full attention to stem cell research funding rather than the startup activities and infrastructure development of the largest and singularly unique enterprise of its kind.
The CIRM has been under virtually constant scrutiny from its inception.  Our experiences with the CIRM and its staff have not always turned out as we had hoped but we have never had reason to question the CIRM’s dedication to fulfillment of the intentions of Proposition 71.  We see no benefit in adding more layers of scrutiny to an already transparent organization. 
The fair pricing sections proposed by SB 1565 are redundant to administrative procedures that we have seen first hand to be working to ensure that all Californians benefit from therapies developed by Proposition 71.
 
With the above in our thoughts, we ask that you oppose the passage of SB 1565.
 
For the sake of completeness, I have attached a cogent editorial written by a colleague, Don Reed.   http://www.dailykos.com/story/2008/7/15/111757/794?new=true
 
Please feel free to contact me with any questions or desire any clarification of our position on SB1565.
 
Jim
 
Jim Kovach, M.D., J.D.
President & COO
Buck Institute for Age Research

The Media Mustard and Meaning of Klein-Kuehl Flap

The Klein-Kos-Kuehl Affair has drawn no attention in the mainstream media and almost none on the Internet – surprising to some deeply involved in the California stem cell scene.

Especially given the history of high profile verbal snafus that have publicly plagued scores and scores of public figures. In a totally different context than stem cell research, the Klein flap recalls presidential aspirants who have been given serious media fits as the result of misguided rhetoric, either from themselves or associates. One only has to look at the Obama-Clinton race to see major political figures wrestling with verbal gaffes.

But the reality is that the comments from Robert Klein's lobbying group, Americans for Cures, concerning an influential state lawmaker's intelligence, knowledge and political fortitude are not even close to making the front page of any newspaper. They may be outrageous, an incredible display of bad judgment and reflect poorly on California's $3 billion stem cell research program, but they do not cut the media mustard.

We cannot find even a single story on the comments in any newspaper in California, much less a current story dealing with the underlying conflicts of interest posed by Klein's dual roles as head of a stem cell lobbying organization and chairman of the leading source worldwide of funding for human embryonic stem cell research. Only two Internet sites that we know of have picked up on the matter, The Niche stem cell blog of Nature magazine and Larry Ebert's IPBiz blog. Monya Baker of Niche largely provided a neutral summary of the events. Ebert made reference to what he called ongoing bungling at CIRM.

We asked one mainstream media reporter about the reasons for the lack of coverage, promising anonymity to guarantee candor. The response:

"It was an easy call that it was not as important as the many other stories on my plate. You know how it goes: Mainstream media has to deal with many more topics than most blogs, including the California Stem Cell Report. For instance, Dave Jensen doesn't have to worry about sharing space on his blog with stories on the price of oil, or failing banks, or city council meetings and murder trials. Blogs also are not expected to meet the same journalistic standards as newspapers, which means they can run items with one source and lots of opinion. And they can touch on the same topic in many different posts, giving incremental developments.

"Meanwhile, newspapers try get several sources and views into one story. We are also dealing with budgetary, staffing and news hole cuts. That means reporters in mainstream media are covering much, much more than just CIRM and stem cells. (CIRM is just one small piece of my very broad and complicated beat.) All that means that I must be much more selective in what I write about."

We also asked John M. Simpson, stem cell project director of Consumer Watchdog, for his views on the media coverage. Simpson had a long career as a newspaper editor prior to holding his current position. He said,

"The news business is in a terrible state. Newsroom staffs have been slashed. Every news organization is trying to do more with less and that's simply impossible.

"Complex ongoing stories, like CIRM and its governance structure, get short shrift in the face of the current crisis in journalism.

"Until somebody figures out a new viable financial model to support quality journalism, we going to see less and less coverage of issues like this. I don't want to sound hysterical, but I think good democratic government is seriously threatened by the sorry state of the mainstream media."

With 30 years experience in journalism, we do not disagree with either our anonymous reporter or Simpson. But we can also add that coverage of state agencies has traditionally been given short shrift in California. It is easier to cover the governor, political activities and only the highest profile legislative issues.

CIRM is off the current agenda for the mainstream media. Does that mean that the issues or specifics involved in the Klein-Kos-Kuehl affair are not important? Far from it. The posting by Americans for Cures was destructive of CIRM's goals. Ironically, the action increased the likelihood that the bill will pass. The vitriol demonstrated indirectly that CIRM is not to be trusted in sensitive dealings. It showcased once again flaws in Klein's leadership that surfaced as long ago as 2005. And it highlighted one of the conflicts that pervade CIRM's board of directors.

The California stem cell experiment is a remarkable endeavor. It has achieved much. But much more remains to be done. CIRM directors should look to finding ways to foster cooperation – not only with the international stem cell community – but here in California, where the home fires are now in need of some renewed and careful tending.

Fresh Comments

Jesse Reynolds of the Center for Genetics and Society, who has followed California stem cell affairs since prior to the passage of Prop. 71, has posted comments on the "Klein Resigns" and "CIRM Letter" items.

Latest Version of SB 1565

Here is a link to the full text of the latest, amended version of legislation, SB 1565, which is aimed at ensuring affordable access to therapies financed by California's $3 billion stem cell agency.

It is the measure that triggered flap that has led to the resignation of Robert Klein, chairman of the agency, as president of his own stem cell lobbying group.

The bill comes before the Assembly Appropriations Committee Wednesday.