With more than 3.0 million page views and more than 5,000 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency. David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.
Tuesday, February 06, 2007
Warm-up for a Big Money Week
But in this case it is a mini-wave, given the committee's busy, two-day agenda – freshly posted on the Web -- during which it is expected to award its first research grants. Ahead of that is a meeting of the legislative subcommittee Feb. 12. The presidential search subcommittee met last month.
In addition to consideration next week of the recommendations on $24 million in SEED research grants, the Oversight Committee will take up a report (not yet online) from the search group. Overseers are scheduled to consider recommendations from the legislative panel involving federal stem cell legislation. Legislative matters at the state level involve two umbilical cord blood bills (AB34 and AB40) and possibly proposed legislation by Sen. Sheila Kuehl, D-Santa Monica, chair of the State Senate Health Committee.
That proposal is not specifically listed on the agenda, but should be discussed if the stem cell directors want to move off their reactive legislative posture.
Also on tap are federal rules (OMB Circular A-21) having to with determining costs on grants. It is not clear why this is on the agenda based on the online material, but it is likely to involve issues of separation of federal and state grant money, since federal grants must be isolated from non-approved stem cell lines.
Remote locations for the legislative subcommittee are available to the public in California in Palo Alto, Chico, Sacramento, La Jolla and San Francisco as well as Maui in Hawaii. No remote locations are available for the Oversight Committee meeting Feb. 15-16 in Burlingame.
Monday, February 05, 2007
Twenty-five Secret Applicants for $48.5 Million in Public Funds
The institute plans to hand out as many as 15 grants, and only 25 institutions have filed letters of intent. Of course, their names are secret by order of CIRM, even though every major University of California campus is certain to have filed. Include Stanford, USC, the Burnham and Salk Institutes, etc., and it is not hard to come up with something close to 25 non-profit and academic institutions. That number may shrink by the deadline for formal applications.
The reason for the secrecy is concern that losing institutions would be embarrassed. Nonsense, we say. Moreover, this is public money that is being given away, and it should not be done behind closed doors any more than absolutely necessary.
According to CIRM's press release, the institutions must provide a 20 percent match of the total cost for renovation and equipment.
CIRM also said,
"The Shared Research Laboratory Grant Program will fund dedicated laboratory space for the culture of human embryonic stem cells (hESCs), particularly those that fall outside federal guidelines. (Current federal policy prohibits research involving hESCs isolated after August 2001 from being conducted in laboratories constructed with any federal funding.) CIRM’s grants will support the development of core laboratories to be used by multiple investigators and shared by multiple institutions, and provide an environment for scientific research on hESCs under CIRM’s medical and ethical standards."The grants are expected to be awarded this June.
Do you think the names of the applicants should be secret? You can respond by using the "comments" function below. Anonymous comments are permitted.
Thal Dies in Small Plane Crash
Thal, a longtime and skilled pilot, was the only person aboard when the plane went down Saturday night, according to a story in the San Diego Union-Tribune by Cheryl Clark and Sandra Dibble.
Thal, 62, was chairman of the neurosciences department at UC San Diego and had served as one of the 29-directors of CIRM since its inception two years ago. The San Diego newspaper wrote that Thal
"was one of the world's leading experts in the development of new therapies for Alzheimer's. He directed the Alzheimer's Disease Cooperative Study, a consortium of more than 70 research centers in the United States and Canada that investigates experimental therapies. He also managed UCSD's Shiley-Marcos Alzheimer's Disease Research Center.In 2004, Thal shared the $100,000 Potamkin Prize, one of the highest honors in neurosciences.
"Thal oversaw more than $100 million in federal research grants and was a collaborator on many others. He and his department had received millions of dollars in research funds over the past 30 years."
The San Diego paper quoted Henry Powell, a professor of pathology and chairman of the UC San Diego Senate academic senate, as saying of Thal:
"He was a skillful manager of strong-minded people, charming and diplomatic as well as visionary and persuasive."Thal was appointed to the CIRM board by the governor.
Magnus: Do We Need More Guidelines?
The proposals came from the International Society for Stem Research. But Magnus asked, "Do we really need another set of guidelines."
Writing in the San Jose Mercury News, he said:
"The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.Magnus also said that the "one really novel stand" from the group concerned payment for eggs for research. He continued:
"All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells."
"The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.The recommendations have been praised by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, who said:
"Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance."
"We are pleased the international guidelines stress public benefit and we will continue to insist that California's regulations provide affordable access to any discoveries or cures resulting from research funded by the state program. Too often stem cell advocates have hyped the immediate benefit of stem cell research. I'm delighted to see the call for realism. The Scientific Strategic Plan for the California Institute For Regenerative Medicine already reflects that realistic approach."Reporter Terri Somers of the San Diego Union-Tribune quoted Larry Goldstein, an ESC researcher at UC San Diego and a member of ISSCR task force, as saying.
“Realizing that stem cell research is an international community, we have to be able to share cells and our scientific methods across borders with some confidence that we have been doing our work to some agreed-upon ethical standards.”
Stem Cell Counsel Owed $110,000
The outside counsel for the California stem cell agency might be having second thoughts about its political connections.
Remcho, Johansen & Purcell of San Leandro, Ca., is owed $111,000 by the political campaign of former Lt. Gov. Carlos Bustamante, according to a story by Sacramento Bee reporter Shane Goldmacher.
Bustmante's campaign owes $390,000, and the largest component of that is Remcho. Bustamante says he hopes to pay it off, but former politicians who are out of office and don't plan to hold office have a hard time raising cash.
Ironically, the second largest debt, $109,000, is to the Bonner Group, a fund-raising firm, which obviously did not raise enough cash to keep the campaign out of debt.
One also might wonder what a law firm did for a political campaign that costs $111,000. Campaigns do need some legal advice but that is 370 hours at $300 an hour. The Bee said Remcho had no comment on the unpaid bills.
Sunday, February 04, 2007
The Pluripotent Presidential Candidate
"Obama is like a stem cell. He can become any part of the body he wants to be."
"He can become the new Democrat that Hillary wanted to be and that Bill Clinton was when he won the nomination."
Comments Update
Friday, February 02, 2007
Promoting California's Stem Cell Giveaway
Reed, who has a keen sense of PR, is pitching Feb. 16 as an "unbreakable date" in San Francisco. On Jan. 31, he wrote on his blog, stemcellbattles.com:
"There will be lots of reporters… If our friends are not there, who will they talk to?The date is when the CIRM Oversight Committee is expected to conclude its decisions on the first wave of more than $100 million in research grants to be dished out this year.
Hint: the opposition will definitely be there…"
Reed is well-connected in the patient advocate community. He knows that TV cameras cannot resist sympathetic interviews with persons afflicted diseases or other problems that could be treated with future stem cell therapies. And the TV audience is likely to be much more sympathetic to their concerns than those opposed to ESC research on theological grounds.
Perhaps state Sen. Sheila Kuehl, D-Santa Monica, is also considering being on the scene, which could be an excellent venue to promote her legislation concerning the stem cell agency. TV rarely covers the agency, and it is not likely to become excited about a legislative story unless it becomes truly extraordinary.
Thursday, February 01, 2007
Legislators Target California Stem Cell Agency
A bipartisan attempt is underway to change the composition of CIRM's Oversight Committee and dictate some terms of its intellectual property policies, among other things. The effort must be bipartisan because a colossal majority of 70 percent of both houses is required to pass a bill affecting CIRM. The governor's signature is required as well.
Reporter Malcom Maclachlan of the Capitol Weekly was the first to break the news about the latest effort to assert legislative influence over CIRM. He said Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley, will author the legislation. Kuehl is the chair of the Senate Health Committee, replacing Deborah Ortiz, who stem cell Chairman Robert Klein once denounced as an "ongoing threat." Ortiz left the legislature because of term limits. Runner is a Republican leader in the Senate, serving as its GOP caucus chair.
Maclachlan wrote that legislation now being drafted would require that two "public interest" representatives be appointed to the 29-member CIRM Oversight Committee. That presumably would mean that two persons now on the board could lose their seats, since the measure does not provide for increasing the size of the committee.
The legislation also "would allow the ICOC to negotiate royalties of 2 percent to 5 percent on any treatments developed via grants to for-profit entities; there would be no cap on the royalties the state could receive."
Maclachan, who has produced a number of stories on the stem cell agency, continued:
"The bill would also force for-profit entities to offer these treatments to the state at the Medicaid prices, rather than the current requirement that they be offered in line with weaker standards under the California Prescription Drug Discount Program. Finally, it would widen the definitions of what state agencies would be eligible for the discounts. Current CIRM regulations limit this to the state discount drug program, while the legislation would open it to any state agency, including prisons and county indigent health-care programs."Maclachan quoted Dale Carlson, spokesman for CIRM, as saying the agency would have no comment until it had an opportunity to review the bill.
Carlson also said:
"We have benefited greatly from the Legislature's advice and counsel in years past, and we look forward to a continuing cooperative partnership. We are interested in any and all ideas that can bring stem-cell treatments and therapies to fruition."Winning passage of the legislation would be a remarkable achievement. No other legislation requires 70 percent approval – not even the state budget or tax increases. Negative votes from only 13 senators can kill the bill. But the measure will certainly provide a forum for lawmakers and others to make their voices heard at more length than the three minutes allowed for each public comment at CIRM meetings.
For more on the reasoning behind the legislation see the item below.
Rationale Behind Kuehl's Stem Cell Legislation
So says the January newsletter put out by Sen. Sheila Kuehl, D-Santa Monica. The newsletter carried a piece by Peter Hansel, staff director of the Senate Health Committee, that discussed the California stem cell agency at some length, including needed changes. Hansel, it should be noted, also served as a Health Committee analyst when it was chaired by Sen. Deborah Ortiz, who is now out of office.
Hansel wrote that Kuehl disagrees with arguments that CIRM should should go easy in terms of royalty requirements and affordable access to cures and therapies. He noted that CIRM has adopted some IP rules that respond to legislative concerns. Hansel continued:
"However, regulations governing the pricing of stem cell therapies in California run counter to assurances given to the Legislature. While at first proposing that grantees and licensees sell such therapies to publicly funded programs at the federal Medicaid price, the CIRM has recently reduced that to a requirement to sell at the same prices they offer them to the state’s new California Prescription Drug Discount Program, a significantly less favorable price. Similarly, the regulations for grants and loans to commercial entities propose to cap the amount of revenues coming back to the state associated with most products developed with Prop. 71 funds, as opposed to giving the state an open-ended return commensurate with its investment. By contrast, New Jersey, which also allows commercial entities to receive grants under its stem cell research program, requires such grantees to share a percentage of revenues—one percent—on an open-ended basis from licensing or commercialization of inventions (two other states that fund stem cell research, Illinois and Connecticut, do not allow for-profit entities to receive funding while another two, Maryland and Illinois have yet to develop policies for grants to for-profits). Capping returns from joint research ventures also appears to run counter to the practices of most universities who co-fund research with commercial entities and the venture capital industry.
"In addition, recent changes require grantees to grant exclusive licenses for inventions they develop to entities that agree to have plans at the time of commercialization to provide access to resultant therapies and diagnostics for uninsured patients, consistent with 'industry standards,' The current industry standard, the patient assistance programs that have been developed by the major drug companies, have been shown to be woefully inadequate in encouraging access to free or reduced price drugs for uninsured persons. Thus, it is incumbent on the CIRM to develop a more meaningful standard than this."
calif legislation, IP, affordability, access, skuehl, phansel
Good to See a Lively Debate
Making a comment is straightforward. Just click on the word "comment" at the end of each item and a form will pop up. You can even make your comments anonymously. Google, which is the site housing the California Stem Cell Report, encrypts the name of the sender so that it is not available to yours truly or others.
CIRM Presidential Search: Bids for Search Firm Perhaps Next Week
The current president, Zach Hall, has the authority to move forward and sign contracts up to $250,000. The search firm contract, which is not likely to exceed that amount, would not have to go to the Oversight Committee, as we presumed in the item below.
Responding to our query, Dale Carlson, spokesman for the institute, also said no documents, other than the presidential criteria, were distributed at Wednesday's presidential search meeting concerning the bid process, timetable or "interim action."
CIRM Presidential Search: Concern Over Leaks, Search Bids Likely
The Presidential Search Subcommittee Wednesday voted 12-1 to seek the bids, we have been told. Presumably that will require ratification by the full Oversight Committee later this month.
Joan Samuelson, a member of the Oversight Committee, was reportedly the only negative vote, saying she wanted to define the job before hiring the search firm.
Some members of the search committee also were not happy about the disclosure that James Battey, the federal stem cell chief, was approached about the job. Their concern was that other good candidates might be driven off.
However, Battey's name was certain to come up as are the names of others who were considered in 2005. At least the names that became public. The California Stem Cell Report has a strong bias towards openness on the part of public agencies, including CIRM. However, this is one case where confidentiality is important. A job search for president that has all its candidates on public display is a poor way to hire good people. That said, it is difficult to control leaks on a high profile job such as CIRM president.
Confidentiality starts with the Oversight Committee. If they discuss names with outsiders, they can expect leaks. Candidates themselves will also lead to leaks if they discuss the job with others, which is likely to be part of their process of evaluating CIRM.
The Oversight Committee can also expect situations like Battey's. His name apparently emerged because of the way the NIH works. That could happen with other candidates as well.
As for the California Stem Cell Report, we will carry the names of candidates if they emerge in news stories and perhaps under other newsworthy circumstances.
Wednesday, January 31, 2007
CIRM Presidential Search: Battey Approached
Nature magazine reported today that Battey, chair of the NIH stem cell task force, had been approached. He was a candidate for the position in 2005 but dropped out of consideration.
In a piece by Meredith Wadman, Nature reported that Battey "has been excused from all stem cell related work" at the NIH. He remains as director of the National Institute on Deafness.
Nature, which did not say which CIRM director had approached Battey, wrote:
"The search committee hasn't discussed a shortlist 'with any real seriousness,' member Joan Samuelson, founder of the Parkinson's Action Network, told Nature on 29 January. 'We need to think about what talents and what skill set we need in the new president. And we should be clear about that before we write a job description,' she said."The magazine continued:
"Battey is highly respected within the NIH as an able administrator who rarely makes trouble, but who will speak frankly when necessary. During the controversy over tightened conflict-of-interest rules at the agency, Battey said bluntly that if it adopted the stringent set of rules thatwas first proposed, he would resign (see Nature 435, 397; 2005). The rules were loosened before they were finalized.When Battey withdrew from consideration for the CIRM presidency in May 2005, he told the California Stem Cell Report that the position at CIRM was "exciting and important" but that his current position at NIH was also an "important opportunity."
"Battey's absence from his NIH stem-cell duties became publicly apparent at a 19 January Senate committee hearing on human embryonic stem-cell research. There, Story Landis, director of the National Institute of Neurological Disorders and Stroke, testified on behalf of the agency. She is now acting chair of the Stem Cell Task Force. It has also emerged that Battey will not be attending a meeting of stem-cell funding agencies being held in Singapore this week."
We queried Battey to see if he has more to say currently on the subject. He did not.
CIRM Guide to the $100 Million Grant Process
Much of the information has been available before but it was scattered and hard to find. Now it has been compiled in a tidy package. Some of the information is fresh. For example, the memo said:
"In the first week of February, we will release a list of all the SEED Grant applications. That list will include the title of the research proposal, the numeric score (1 to 100) it received from the Grants Working Group, and the Working Group’s recommendation (Recommended for funding, Recommended if funds available, or Not recommended for funding at this time). From our Web site, viewers can click on the application number to open a public abstract of the proposal, a statement of its benefits to California, the applicant’s proposed budget, and a summary of the Working Group’s review."The memo also reiterated the agency's intention to maintain its secrecy concerning the names of those seeking millions of dollars in government funds – a dubious practice adopted because that it is the way it always been done (at least on the federal level) to protect rejected applicants from embarrassment. We should note that some of the applicants have already disclosed that they have applied, making the attempt at secrecy a bit ineffectual and raising questions about why the applicants disclosed when the granting agency prefers secrecy.
The memo was prepared originally for use by the ink-stained wretches of the media, but it has value for anyone interested in the grants. You can clip it and post it on the outside of your petri dish.
Tuesday, January 30, 2007
MSU Clears Cibelli of Misconduct
Cibelli asked for the MSU investigation as a result of his connection with the Korean stem cell scandal. He was the co-author of the fraudulent March 2004 paper that reported the first-ever closed human stem-cell line.
A letter signed by the university intellectual integrity officer was provided by Michigan State University to the California Stem Cell Report. The letter said in part:
"The excerpts below summarize the findings of the IC(investigative committee):Dale Carlson, spokesman for CIRM, told the California Stem Cell Report:
'After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.'
"The report further states:
'His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.'"
"Cibelli was an enthusiastic, valuable member of the group and we'd like very much to see him back."Carlson added that further information would have to wait until CIRM President Zach Hall returns from a trip to Singapore.
Cibelli voluntarily withdrew from active participation in the standards working group after the Korean scandal erupted.
Below is the full text of the MSU letter concerning Cibelli. We have asked the university for a complete copy of the report that is referred to in the letter.
Text of Cibelli Letter
January 26, 2007
This letter is to inform you that Michigan State University has just completed its Investigation into the Allegation of Misconduct in Research against Dr. Jose Cibelli, Professor, Department of Animal Science and Physiology, under MSU’s Procedures Regarding Allegations of Misconduct in Research and Creative Activities. The Investigative Committee (IC) found that no Misconduct in Research occurred.
Immediately after learning that the paper he co-authored, “Evidence of a pluripotent human embryonic stem cell line derived from a cloned blastocyst”, Science 303:1669-1674, reported data from fraudulent research, Dr. Cibelli voluntarily went to MSU’s University Intellectual Integrity Officer (UIIO) seeking an evaluation of his contributions to the manuscript. Dr. Cibelli’s review included a Preliminary Assessment by the UIIO, an Inquiry conducted by three colleagues of an Inquiry Panel and a formal Investigation conducted by three colleagues who comprised the IC. Review of Dr. Cibelli’s case took approximately one year.
The excerpts below summarize the findings of the IC:
After considering all the testimony and evidence available to it, the IC finds that the Respondent did not commit Misconduct.
The report further states:
His support for, and participation in, the 2004 manuscript were motivated by his natural enthusiasm for NT cloning and human ES cell research, his hopes that the field will progress and his well-meaning desire to participate appropriately in that overall effort.
Please consider this finding of no misconduct in future interactions with Dr. Cibelli.
Sincerely,
James M. Pivarnik, Ph.D.
University Intellectual Integrity Officer
FTCR: No to Research and 'Big Name' for Next CIRM President
John M. Simpson, stem cell project director for the Foundation for the Taxpayer and Consumers Rights, sent a letter to CIRM today and issued a press release on the subject, following the ealier item ("Move with Dispatch") below in the California Stem Cell Report. (Also see Simpson's comment on that item in which he quotes an unidentified Oversight Committee.)
In his letter, Simpson said:
"The next president must be an extremely competent hands-on scientific administrator, who can set up and maintain transparent and accountable management systems. He or she must be able to interact with the public, state officials, legislators and the media in a transparent, honest and accountable fashion.Simpson's statement came as CIRM posted a seven-page document on its Web site describing proposed criteria for the new president. That document, coming only one day before the meeting of the presidential search subcommittee, will serve as the framework for that panel's discussion. Other background information relating to hiring a search firm, whether that process should be open to bids, timetable for hiring and "interim action" was not available. The lack of that information makes it extremely difficult for the public to comment intelligently and belies CIRM's ostensible commitment to openness and transparency.
"In the past there has been some suggestion that the president might continue to maintain research laboratory as part of the president's role. This should not be allowed. The presidency of CIRM is more than a full-time job. A person trying to manage CIRM's activities and conduct meaningful research simultaneously would do justice to neither activity.
"Members of the search committee should avoid the temptation of seeking a 'big name' scientists known for his or her discoveries. The emphasis must be on the individual's skill in scientific management and administration."
Much of what is contained in the presidential criteria document, which presumably emanated from the office of stem cell Chairman Robert Klein, is predictable. A preliminary look, however, raises suspicions about whether it is a first step in shifting the existing balance between the president and the chairman (see the section on management reporting lines of authority). The overlapping, dual leadership at CIRM has been a troubling aspect of the agency since its earliest days, surfacing in public conflicts involving Klein and current President Zach Hall, who is retiring by about mid-year. Prop. 71 codified the dubious executive structure in a state law that is nearly impossible to change without another vote of the people.
The 3 p.m. meeting of the search subcommittee will be in San Francisco, but remote locations are available to the public in Washington, D.C., Los Angeles, UC San Francisco, UC Berkeley, La Jolla, Ca., Carlsbad, Ca., Stanford University and the San Francisco city attorney's office. The agenda does not indicate specific room numbers in some cases. Email CIRM directly, info@cirm.ca.gov, or phone the agency at 415-396-9100 if you would like more details on the locations.
Sunday, January 28, 2007
CIRM's Presidential Search: Time to Move with Dispatch
Those are some of the questions likely to be addressed as CIRM's presidential search committee convenes on Wednesday with remote sites for the public available from Washington, D.C., to Chico, Ca.
The specific agenda for the meeting is a bit sketchy as of this writing, reminiscent of CIRM meetings of yore in which background material was not available until the day of the meeting, making it difficult for even CIRM Oversight Committee members to comment intelligently much less the public.
On the table are job summary and criteria, the search process and possible competitive bidding for a search firm, the time table and "interim actions." The last item would seem to involve a temporary appointment while the search for a permanent replacement for Zach Hall continues. The 69-year-old Hall has indicated he wants to be off the job no later than June.
The last presidential search in 2005 failed to produce a result until September of that year, three or four months after it had been expected. And that was a man, Zach Hall, already filling the spot on a temporary basis.
The tenuous legal position of CIRM, which then faced the lawsuit now on appeal, was one of the reasons for the apparent difficulty in hiring a president. Another matter of concern among some candidates was whether they could conduct research and whether CIRM would provide facilities. That came up in August 2005 at a meeting of the search subcommittee.
Issues involving the dual leadership at CIRM – a president and chairman with overlapping responsibilities – surfaced early in 2005 with the search subcommittee. It is likely to be a continuing concern although stem cell Chairman Robert Klein has indicated he may give up his post in 2008. But even if he does, another question arises: Who would replace him and can the next president hammer out a new working relationship with the next chair?
California is an expensive place to live, especially the San Francisco Bay Area, where CIRM is headquartered. So compensation becomes especially important for those from out of state. The CIRM salary scale drew protests as excessive in 2005, but it is not likely to be revised downward.
Most involved with CIRM seem to agree that Hall's performance has set a high standard. He laid the difficult groundwork that may have deterred some early candidates. His performance has also clarified for the the Oversight Committee what is needed in a president and creates certain expectations. CIRM is a tiny organization with about 20 employees, substantially fewer than the 29-person Oversight Committee that oversees it. Leadership changes are always difficult for any enterprise. But smaller organizations are more susceptible to disruption than larger ones with substantially more momentum or, for that matter, inertia. CIRM could suffer if too much time passes without a permanent replacement for Zach Hall.