Wednesday, August 06, 2008
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.
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.
Tuesday, August 05, 2008
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.
Monday, August 04, 2008
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.
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,
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,
His reponse:
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.Aghast we were. Do you really mean that, John, we promptly emailed him back.
"I only let my wife read it under my direct supervision and would never contemplate allowing my adult children to see it."
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.)
Sunday, August 03, 2008
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.
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:
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.We have asked CIRM for a copy of the statement from the attorney general's office that supports the ongoing, no-bid arrangement.
"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."
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.
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:
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"
Friday, August 01, 2008
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.
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.
Thursday, July 31, 2008
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.
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.
Wednesday, July 30, 2008
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."The AP story continued:
"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."
"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.But Wohlsen quoted Marcy Darnvosky of the Center for Genetics and Society as saying,
"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."
"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.
Tuesday, July 29, 2008
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.
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.
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,
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,
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.
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.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.
"I told him that his name was still on the website. He said he'd call them to have it removed."
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.
Monday, July 28, 2008
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.
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."
Thursday, July 24, 2008
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,
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.
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.The Bee continued:
"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."
"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.
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