The National Academy of Sciences: Feeding the Anti-Science Movement

The National Academy of Sciences has not distinguished itself with its response to the flap about barring the public from a meeting of public officials discussing interstate cooperation on billions of dollars in stem cell research financed with taxpayer funds.

We have not heard from the academy concerning the hooha but it finally responded to a letter of protest from John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights of Santa Monica, Ca., who was ousted from the meeting in California last month. An academy official said the meeting was "private" although state officials were there at taxpayer expense discussing issues of public import in at least 10 states.

The letter from the NAS demonstrated a fundamental failure to grasp that secrecy on this subject is not in the best interests of the public or of the academy. Closing the door only generates suspicion and distrust and unnecessarily feeds the anti-science movement in this country.

Here is the text of NAS letter to Simpson and Simpson's response. First the letter of E. William Colglazier, executive officer of the NAS.

"I am responding to your letter of May 24 regarding the meeting at the Beckman Center in Irvine, California, on May 23 and 24 involving representatives of states involved in stem cell research. That meeting was an invitation-only planning session, which we were requested to convene, to discuss the potential interest of states regarding sharing information and improving coordination in the future. As the states decide how and when to move forward with information sharing and interstate coordination activities, I expect that there will be ample opportunities for public involvement."

Simpson's reply:

"Thank you for your June 13 response to my letter of May 24 expressing concerns about the private meeting of representatives of state stem cell research programs. You give me great comfort.

"Any doubts that I had about earlier characterization of the National Academy of Sciences as a paternalistic organization that believes the public cannot be trusted to understand science have been put to rest.

"Moreover, your suggestion that 'there will be ample opportunities for public involvement' in the future misses the point.

"The meeting in Irvine, CA, was of representatives of publicly funded stem cell research programs talking about public policy. The public should have been involved from the beginning, not at some vague future date at the convenience of the scientific bureaucracy.

"You should apologize for closing the meeting, and any future sessions of this group must be open to the public.

"The National Academy of Sciences' paternalistic approach only serves to undercut public confidence in any policies that may emerge from the interstate meetings. This does not serve the interests of the states, the National Academy nor stem cell research."

As we mentioned earlier, public officials from any state should not attend any further closed-door meetings on this matter. No good reason exists for banning the public. All of the issues can and should be discussed in public. Airing differing views early is one good way to write intelligent policy and build public support.

(Editor's note: An earlier version of this incorrectly quoted Simpson's letter as saying xxxx at the convenience of the scientific democracy (instead of bureaucracy).

Public Matters, Public Money Topic of "Secret" Agenda

For a look at what one might call the "secret" agenda discussed during last month's closed-door session promoting interstate cooperation on stem cell research, you can find the documents posted on the web site of the Foundation for Taxpayer and Consumer Rights.

The National Academy of Sciences barred the public from the California meeting. An academy official said the session was private despite the fact that it involved public officials, dealing with public matters and public money.

John M. Simpson, stem cell project director for the foundation, received the documents before he was ousted by the academy official.

Topics discussed at the Irvine, Ca., session included intellectual property (not a small matter for California taxpayers), reciprocity between states, model legislation and research oversight. All are clearly part of the public agenda on embryonic stem cell research.

Ironically, also on the table was a draft mission statement, calling for the nascent "Interstate Alliance for Stem Cell Research" to promote "efficient and responsible use of public funds." Ironic because private, closed door meetings discussing how to use billions of dollars in taxpayer funds can hardly be called responsible.

For more on this subject, see the "Fails Responsibility" below.

Transcript Now Available on SB771

The transcript of the meeting of the CIRM Intellectual Property Task Force dealing with SB771 is now available online at this link. The meeting was the subject of the "looming compromise" item below.

National Academy of Sciences Fails Public Responsibility Test on State Stem Cell Issues

"Absolutely outrageous," "outmoded, elitist" complete with a "public-can’t-understand-science attitude" -- the National Academy of Sciences.

That is the description of the group as provided by John M. Simpson, the normally mild-mannered stem cell project director of the Foundation for Taxpayer and Consumers Rights of Santa Monica, Ca., who has trekked north and south through California for a couple of years following and influencing California's $3 billion stem cell research effort.

Simpson was justifiably irked when he was barred last month from a NAS-supported meeting of public officials by Fran Sharples, life sciences director of the the NAS. Simpson had been invited to the first meeting of the group in Connecticut, but could not attend. When he showed up for a follow-up meeting in Irvine, Ca., Sharples said that it was private and he could not attend despite having being invited earlier.

But invitation or not, Simpson's point is that this is public business – not some private, secret affair.

Attending the session in May were representatives of 10 state public stem cell research programs from across the nation. The two-day session was aimed at creating the Interstate Alliance for Stem Cell Research. Among its goals would be "creating opportunities for collaboration among different states' stem cell programs and harmonizing regulations."

All of which is of great importance to state research efforts, which are funded by public money – not NAS funds – and which are generally required to operate in public under open meeting and open records laws.

Simpson wrote a letter of protest to Ralph J. Cicerone and E. William Colgazier, respectively president and executive officer of the academy, concerning its egregious behavior.

Simpson said,

"When the public is shut out of the process, we can only wonder what is being done behind closed doors. For instance, in the quest to 'harmonize' regulations between states will only the lowest common denominator in regulations be adopted?"

And again this month, Simpson said,

"We completely support efforts to foster co-operation among the states, but the notion that the National Academy of Sciences would close such a meeting to the public is absolutely outrageous. It is the outmoded, elitist, public-can’t-understand-science attitude, that ultimately undermines the public’s willingness to fund research. It’s time NAS moved into the 21st century. Their current behavior is exactly what prompts the know-nothing attitude of our president and his right-wing base."

The National Academy of Sciences is a nonprofit organization created by Congress. The intent of Congress was to create an organization that serves the public, albeit indirectly. The Federal Advisory Committee Act which deals with the NAS seems intended to open rather close the academy's proceedings. The action last month in Irvine barring the public from an important stem cell meeting violates the intent if not the letter of that law.

We have asked the NAS for a response or justification (including information on its funding sources) but it has not responded. Nor has it yet responded to Simpson's letter of 18 days ago. We will carry the group's statement verbatim when we receive it.

For now, however, the academy should be embarrassed by its highhanded conduct. Moreover, closing the doors on the public is harmful to the academy and defeats its purpose of advancing the cause of science. Instead the NAS is breeding suspicion and distrust.

The California stem cell agency, as well as those in the other states, should boycott any further meetings of the NAS on the subject of interstate cooperation unless it is willing to open the sessions.

Looming Compromise on CIRM Legislation?

The California stem cell agency seems to be heading towards something of a partial compromise concerning legislation aimed at ensuring a fair return to the state on its $3 billion stem cell research effort.

The bill – SB771 –is now in the Assembly after passing the Senate on a whopping 38-0 vote. Sen. Sheila Kuehl, D-Santa Monica, chair of the Health Committee, and Sen. George Runner of Antelope Valley, one of the Republican leaders, are co-authors.

The legislation came up for discussion at a meeting late last month of CIRM's Intellectual Property Task Force. Duane Roth, a San Diego pharmaceutical company executive and member of the CIRM Oversight Committee, suggested a modification in sharing net license revenues from CIRM-funded inventions.

According to one Senate analysis:

"The proposed commercial regulations by CIRM require that 17 percent of licensing fees in excess of $500,000 be paid to the state, that three times the grant amount be paid for patented products supported by CIRM, and that the state be entitled to 1% of all revenues in excess of $500,000 for the life of a patent if CIRM provided support over $5 million.

This bill would, instead, require the CIRM regulations provide the state 25% of net licensing revenues resulting from supported research; grant exclusive licenses to firms intending to provide access to resulting therapies to uninsured Californians."

Roth proposed changing CIRM's commercial regulations, which are still being drafted, to 25 percent as in the bill instead of the previous 17.

Roth told the IP task force, according to the transcript:

"I don't think it matters that much to industry that's going to take CIRM money, have an invention, and then license to a third party, whether they keep 83 percent of the revenue or 75 percent. And the reason I'm bringing it up is...it's difficult to explain. It can be explained, but it's difficult. And I think the rationale behind it is the hardest part of the explanation."

Roth also said a change would indicate that CIRM is willing to meet Kuehl halfway on the bill.
A quorum was not present at the IP Task Force meeting, so the group did not take an official vote. But no opposition to the change was expressed. An official policy change would require a vote of the full Oversight Committee, which opposes SB771.

The IP meeting occurred before the measure passed the Senate on the 38-0 vote.

Also discussed at the Task Force meeting was another issue related to SB 771 – affordable access. CIRM has moved away from language linking access to Medicaid prices.

Scott Tocher, a CIRM attorney, outlined problems with the Medicaid price and the rationale for linking access to the California RX Discount program, whose regulations are being formulated by the California Department of Health Services.

Kuehl's bill would require licensees of CIRM-funded therapies to provide access at Medicaid prices to patients whose care is provided with public funds.

The Task Force transcript is expected to available online soon on the CIRM web site.

More on Cha Retraction

Both the Los Angeles Times and The Scientist magazine have reported on the retraction involving Alan DeCherney and Kwang-Yul Cha, which we carried on June 7.

Here are the links to the story in the Times by William Heisel and the piece in Scientist byAndrea Gawrylewski.

A Commercial Perspective on Resetting Stem Cell Clocks

Andrew Pollack of the New York Times wrote a piece Thursday that contained some interesting comments from California folks on mice and resetting their stem cell clocks.

Some excerpts:

"'Once you muck around with the genome, all bets are off,' said Dr. Thomas B. Okarma, chief executive of Geron, a company trying to develop medical treatments from human embryonic stem cells. Dr. Okarma said getting approval from the Food and Drug Administration would become 'enormously more complicated.'"

Pollack continued:

"Joydeep Goswami, vice president for stem cells and regenerative medicine at Invitrogen, a company that sells tools for stem cell research, said the new technique could get more companies interested in stem cells.

"Not only does it eliminate the ethical issues, he said, but it also might provide a way around stem cell patents held by the University of Wisconsin that some scientists and corporate executives say have hindered work in the field.

"Still, an even bigger hurdle for investors has been the uncertainty of whether stem cells can be turned into lucrative medical treatments. Some experts say this might take a decade or more, too long for many investors to wait."

More from Pollack:

"Dr. Okarma of Geron pointed out that after mouse embryonic cells were first isolated, it took about 18 years before human embryonic cells were similarly derived. Geron, based in Menlo Park, Calif., paid for the work with human cells at the University of Wisconsin and has exclusive commercial rights to certain types of tissues created from human embryonic stem cells.

"Dr. Okarma also said it might not be desirable to use skin cells as a starting material because they might have been genetically mutated by exposure to ultraviolet radiation."

Pollack continued:

"William M. Caldwell IV, chief executive of Advanced Cell Technology, said his company had not been able to obtain enough human eggs needed for therapeutic cloning. So the new approach, Mr. Caldwell said, is 'a technology that everyone should take a hard look at.'"

Fertility and Sterility Editor Retracts Comments About Cha

The editor of the Fertility and Sterility Journal has retracted and apologized for his remarks alleging plagiarism and perjury linked to Kwang-Yul Cha, a South Korean scientist whose organization includes a Los Angeles lab that was approved for a $2.6 million California stem cell grant.

The May 31 letter was written by Alan DeCherney to Cha following articles in the Los Angeles Times and The Scientist concerning DeCherney's allegations. The charges received additional attention after CHA RMI in Los Angeles successfully competed for the CIRM grant.

Following approval of the research funds, two organizations that monitor CIRM said the news reports raised troubling questions.

Here is the text of the DeCherney letter, written on the letterhead of the American Society for Reproductive Medicine. The letter was supplied to the California Stem Cell Report by a representative of the Cha organization.

"Dear Dr. Cha,

"I am writing to apologize for the distress and any reputational damage my statements to The Scientist (February 20, 2007) and the Los Angeles Times (February 18, 2007) have caused you and your organization. Considering the facts of the matter, I consider my references to 'plagiarism' and 'perjury' to be inaccurate and regrettable. I hereby retract them and give you permission to forward this letter to the authors of both articles, and to their editors, for their information. You may use this letter in full form publicly in any way that you wish.

"I regret that I did not contact you or the other authors earlier to determine the facts of the matter, since it was brought to my attention more than a year ago. Please accept my apology for my hasty remarks to the reporters.

"After checking our records, I acknowledge that Dr. Jeong-Hwan Kim's name was included as an author when the manuscript was originally submitted, though I am not aware of the circumstances that ultimately led to his exclusion from the list of authors. I also acknowledge the fact that two formal requests were made in 2006 (after publication of the article in F&S) asking that Dr. Kim be added to the article as an author and that I did not respond to either of them.

"I want to emphasize that we found no scientific fault with your paper: "Quantification of mitochondrial DNA using real-time polymerase chain reaction in patients with premature ovarian failure," published in Sterility and Fertility. In accordance with the press release issued by the Fertility & Sterility board in April, we determined that you were not responsible for the dual publication. While the Board did not consider the issue of authorship, I have no reason to believe that you should not receive credit as first author. This would be consistent with the customary practice in the United State of the Corresponding Author providing the appropriate authorship credits.

"We hope that this will not discourage you and your scientific colleagues from submitting original research articles to Fertility and Sterility in the future.

"Sincerely,

Alan DeCherney, MD"

Funding of all the grants approved in March, including CHA RMI, has not yet begun. CIRM is reviewing them all as part of its normal practice to assure that each grantee can comply with the terms of the grant.

If you are interested in a PDF copy of the DeCherney letter, please send a request to djensen@californiastemcellreport.com. If you would like to read more on this subject, we have posted a number of items in March and April. You can find by using the search term CHA.

Turning Back Time on Mice Stem Cells: Implications for California

Does the news that scientists have found a way to reset the clock on adult mice stem cells mean that the California stem cell institute should fold its $3 billion tent and slink off into the night?

A case can be made that announcement reduces the imperative behind CIRM, formed to fund research into human embryonic stem cells because of President Bush's restrictions on federal financing in that area.

But scientists and CIRM are having none of it. Indeed, the Japanese scientist, Shinya Yamanaka of Kyoto University, who made the initial discovery in 2006 predicts that duplicating the procedure in humans would be "more demanding" than the mouse work.

At least three California newspapers visited the subject today, reporting that CIRM and researchers say the development, if ultimately successful, will take years to prove useful in humans and offers just another avenue for potential CIRM funding.

Carl Hall of the San Francisco Chronicle wrote:

"Arlene Chiu, interim chief scientific officer at the California Institute for Regenerative Medicine, the agency in charge of the state's $3 billion stem cell program, said the new work shows a path around a major bottleneck -- the shortage of fresh human eggs available for research.

"'We are interested in new ways of generating pluripotent stem cells,' she said. 'The important thing to us is the product, not the process. But the rarity of eggs is definitely a challenge.'

"Ethical rules in California and other states forbid paying women who undergo the sometimes risky egg-extraction procedures. Harvard's Kevin Eggan, a senior scientist involved in the new experiments, said Wednesday that he and his colleagues have been unable to find even a single egg donor after a year of looking.

"Ethics aside, Eggan said the real reasons his lab pursued an alternative to egg donation 'are really scientific and logistical in nature.' Researchers, he said, are seeking a way to use nonviable embryos.

"In fertility clinics, somewhere between 3 and 10 percent of women's eggs are improperly fertilized, typically with an extra sperm getting inside. That translates into about 15,000 to 50,000 nonviable, one-celled embryos, also known as zygotes."

Steve Johnson of the San Jose Mercury News quoted Christopher Thomas Scott, executive director of Stanford's Program on Stem Cells in Society as saying much more work needs to be done before the techniques can be used in humans:

"To kind of claim that one study is going to do the trick isn't the way that science works."

Johnson also reported that Arnold Kriegstein of UC San Francisco

"... noted that much of the embryonic stem-cell research going on in California involves examining how to turn cells into treatments. Consequently, he said, the knowledge gained from that will be useful no matter which types of cells - embryonic or reprogrammed - ultimately are determined to be best."

Terri Somers of the San Diego Union-Tribune had this on the impact of the latest research announcement.

"'It's really remarkable work . . . and as big as Dolly (the cloned sheep) in lots of ways,” said Alan Robbins, chief technology officer at Novocell, a San Diego-based stem cell company. 'If it can be translated into humans, then it opens up the way for designer embryonic stem cells.'"

Gautam Naik of the Wall Street Journal also put together an excellent piece with a great deal on the background and implications of the research.

TV Stem Cell Coverage, Reijo Pera and Stanford

Television rarely covers California stem cell issues yet the medium is one of the most important sources of news for the public.

That is one reason why we like to point out TV coverage when it does occur, as in the case of a report by Erik Rosales on San Francisco station KGO.

He put together a roughly two-minute piece Tuesday, built around the lab grants approved by CIRM's Oversight Committee. Rosales filmed folks at Stanford, featuring Renee Reijo Pera, director of human stem cell research at the school.

You can see the entire piece here, complete with an ad that provides the full commercial TV experience. Click on the image of the hand in the latex glove to start the video.

On the subject of news coverage of Tuesday's grant approval, we should note that it received no TV coverage in Los Angeles as far as we can tell. CIRM called a news conference for noon Tuesday in Los Angeles but no reporters turned up. As we reported earlier, only one main stream media reporter was present for the session of the Oversight Committee, Terri Somers of the San Diego Union-Tribune.

Los Angeles is a tough news town, and it usually takes more than handing out $50 million to generate coverage. Perhaps if CIRM had shot the money out of a cannon in the Rose Bowl and had researchers run for the dough....

CIRM Legislation Easily Clears the California Senate

The California State Senate today overwhelmingly passed legislation aimed at ensuring a return to the state on its $6 billion stem cell research investment as well as providing affordable access to therapies that may be developed.

The bill, SB771, cleared the Senate on a 38-0 vote. It now goes to the Assembly, where it also requires a three-fifth vote for approval, not to mention passage through at least two committees.

The measure is authored by Sen. Sheila Kuehl, D-Santa Monica, chair of the Senate Health Committee, and Sen. George Runner of Antelope Valley, chair of the Senate Republican Caucus.

The size of the vote in favor of the bill seems to indicate that the opposition to the bill by the California stem cell institute and the state's biotech industry has not been effective so far. But the vote also could reflect the strength of its authors in the Senate, where their colleagues might be reluctant to offend. The Assembly could be a different matter.

We have not yet seen any news stories on the Senate vote. Those may not be available until Thursday.

(Regarding the $6 billion figure in the first paragraph, that represents the total investment by the state: $3 billion for research and $3 billion in interests for state bonds.)

CIRM Lab Grants: News Coverage Around California and China

Here are links to additional news stories on the $50 million in lab grants approved Tuesday by the California stem cell agency.

Lisa Krieger, San Jose Mercury News, story also appeared in Woodland Daily Demorat, Contra Costa Times and San Mateo County Times, excerpt:

"'We're hoping our facility will be a dynamic place for people to learn and share ideas about embryonic stem-cell research,' said Renee Reijo Pera, professor of obstetrics and gynecology and director of human stem-cell research at Stanford. UCSF's Arnold Kriegstein, director of the university's stem-cell program, said: 'It's terrific. We'll be able to double the size of our research facilities.'"

Xinhua news service, People's Daily, China, excerpt:

"'Once again, our state is leading the nation in stem cell research,' (Gov. Arnold) Schwarzenegger said. 'With the grants announced today, California has issued more than 200 million dollars in grants to pursue potential therapies and cures for debilitating diseases."

Gary Robbins, Orange County Register, excerpt:

"UC Irvine has collected an additional $3.9 million for the study of human embryonic stem cells, raising its backing from the state to about $17.5 million and making the campus among the most heavily funded in the world in this nascent area of biomedical research."

David Raclin, Riverside Press Enterprise, excerpt:

"The grant is UCR's third of the year from the California Institute for Regenerative Medicine. Two UCR professors were awarded a combined $1.1 million in February."

Richard Halstead, Marin Independent Journal, excerpt:

"(Jim) Kovach (president of the Buck Institute) said it is too early to say if the Buck Institute is likely to aggressively pursue additional grants from the California Institute. Kovach said the Buck Institute might need to dedicate an entire building - 60,000 square feet or more - to succeed in that endeavor."

San Francisco Business Times, excerpt:

"The new shared research laboratory (at the Buck Insititute)will consist of 36 lab benches and spaces for equipment and procedures commonly used in stem cell research. The training facility will include a multi-purpose room and office space for weeklong training courses that will take place four times each year.

Shanna McCord, Santa Cruz Sentinel, excerpt:

"With the grant money, UCSC plans to build a central facility on campus dedicated to human embryonic stem cell research, train scientists and provide new opportunities for faculty, said Ann Pace, assistant director for UCSC's Center for Biomolecular Science and Engineering. Renovation of the Sinsheimer Building on Science Hill is part of the plan, including the development of laboratory suites and training rooms, Pace said."

Jeanmarie Todd, Bloomberg, excerpt:

"The grants are 'a prelude to the $222 million in major facility grants'' the institute will consider 'early next year,' according to an e-mailed statement today(6-5-07)."

The Los Angeles Times, The Sacramento Bee and Davis Enterprise do not seem to have carried stories today. Links to the San Francisco Chronicle and San Diego Union-Tribune were carried Tuesday(see below).

Correction

The "Gives Away $50 Million" item on June 5, 2007, incorrectly stated that of the institutions represented on the Oversight Committee, only one did not receive a lab grant. Actually, there were two, Cedars-Sinai in addition to the City of Hope. Our thanks to the person who called this to our attention.

Lab Grant News Coverage

Here are links to two stories today on the CIRM lab grants(see the item below): Terri Somers, San Diego Union-Tribune, and Carl Hall, San Francisco Chronicle. Hall was not present at the Los Angeles meeting.

Stanford Fires First

Stanford publicist Amy Adams was the first out this afternoon among recipient institutions with a press release on the $4.1 million grant to her Palo Alto institution. You can find her item here.

CIRM Gives Away $50 Million for Stem Cell Labs

"We have to be as generous as we can," said Duane Roth, a member of the Oversight Committee that controls the $3 billion California state stem cell research effort.

The comment from the CEO of Alliance Pharmaceutical Corp. came shortly before the board approved its first-ever laboratory grants – some $50 million to 17 institutions. Twenty-two applied.

Roth echoed comments from others on the 29-member committee. Claire Pomeroy, dean of the UC Davis Medical School, said, "We're building an array of services across the state."

A handful of the committee members raised questions about whether the panel should be more or less generous than reviewers who made recommendations to the full committee. David Baltimore, former president of Caltech, said, "When a vote has been taken, it sets a very high bar to change that recommendation."

He said the Oversight group should exercise lest it undercut the grant review process.

CIRM's press release said:

"These facilities are scheduled to be complete and available to researchers within six months to two years of the grant awards.

"The grants 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 that may be shared by multiple institutions, and provide an environment for scientific research on hESCs under CIRM’s medical and ethical standards."

It continued:

"The grants will provide funds for the design and renovation of laboratory space, equipment for the new research facilities, and operating expenses for three years. Six of the recipient institutions will receive additional funds to provide training courses for scientists and technical staff in the growth and maintenance of hESCs."

The release quoted stem cell Chairman Robert Klein as saying,

"'Today we passed the $200 million mark in funding for embryonic stem cell research. The grants approved today are a prelude to the $222 million in major facility grants we’ll consider early next year. It’s critically important that California provide a ‘safe harbor’ where scientists can work on new stem cell lines without endangering their institutions’ federal funding. It’s equally important that we help finance new facilities to house the growth of this emerging life sciences field. These grants establish a great collaborative model that leverages the intellectual capital of California’s leading scientific institutions for the benefit of all Californians.'"

Here are the recipient institutions: Salk Institute, $2.3 million; Buck Insitute, $4.1 milion including a stem cell techniques funding course; Scripps, $1.7 million; UC Davis, $2.8 million; UCLA, $2.9 million; UC Santa Cruz, $2.7 million; Children's Hospital Los Angeles, $2.8 million; UC Riverside, $2.9 million; Burnham Insitute, $3.8 million including course funding; Gladstone Institutes, $1.7 million; Stanford, $4.1 million including course funding; UC Berkeley, $2.1 million; UC Santa Barbara, $2.3 million; UC San Diego, $2.8 million; UC San Francisco, $3.9 million including course funding and USC $3.6 million including course funding.
 
UC campuses in Davis, Riverside, Santa Barbara and Santa Cruz as well as Scripps moved into funding positions after receiving "mixed" recommendations from the two initial review groups.

Fourteen representatives from the institutions applying for the grants sit on the Oversight Committee. All but one of those institutions, the City of Hope, received funding. Oversight Committee members are barred by law from voting on or participating in discussions involving grants to their institutions.

Only one mainstream media reporter was present for the today's session, Terri Somers, of the San Diego Union-Tribune.

Correction

The "CIRM Tonight" item below omitted UCLA as one of the institutions that was recommended for funding by both groups. Thanks to the gent from UCLA who pointed this out.

Gaucho Scientists Likely to Win Stem Cell Grant

UC Santa Barbara appears to be on its way to winning a $1.8 million stem cell lab grant from the California stem cell institute.

That was the biggest development out of Monday night's meeting of CIRM's Oversight Committee, which met at the Luxe Hotel on Sunset Boulevard in Los Angeles.

The committee did not have a quorum, so it could not take official action. But the group approved a recommendation to move the UCSB grant to the top tier of grants expected to be approved.

The application had received low marks from the facilities working group but was ranked high for its research plans. The low marks were mainly related to construction costs in Santa Barbara, which is one of the more expensive areas in which to build in California.

No Gauchos, as UCSB denizens are known, appeared before the committee. Nor did representatives of any of the other lower ranking proposals make a last minute pitch to save their plans for stem cell labs.

Perhaps they will appear Tuesday morning, but we suspect they are not fully aware that they can appear before the Oversight Committee to explain why their proposals are worthy of funding.

CIRM Tonight: Juggling $48 Million in Lab Grants

The California stem cell institute meets this evening to hand out as much as $48.5 million for laboratories for embryonic stem cell research.

A news conference is scheduled for noon on Tuesday to announce CIRM's actions, but it is likely to be mostly settled by 9 p.m. PDT or so tonight. We will carry a report following the end of the meeting.

The ultimate decision on the grants is made by the Oversight Committee of the institute, which is the group meeting this evening. But it has been loathe to make significant changes in grant recommendations by its working groups.

The 22 applications were reviewed by two CIRM working groups –- one that focused on facilities and one that was more oriented towards the research.

Recommended for funding by both the facilities and grants working groups are grants to the Salk Institute, Buck Institute, Burnham Institute, Gladstone Institute, Stanford, UC Berkeley, UC Irvine, UC San Diego, UC San Francisco and USC.

No funding was recommended on applications from UC Riverside and the Palo Alto Institute of Medicine by both the facilities and grants groups.

The facilities group recommended no funding for UC Santa Barbara, but the grants group gave it a favorable recommendation.

Negative recommendations were made by the grants group on applications from Scripps, Cedars-Sinai, UC Davis, UC Santa Cruz, Beckman Research Institute (City of Hope), Blood Systems Research Institute (San Francisco) and California Pacific Medical Center Research Insitute (San Francisco). But facilities group gave these insitutions a favorable recommendation.

Copies of the applications, rankings and much, much more can be found here.

CIRM's Research Standards -- A Look at Their Principles and Reasoning

If you looking for a good overview of the rationale and background for the research standards enacted by the California stem cell agency, check out an article on PLoS Medicine by three men deeply involved in the subject.

The piece is called "Responsible Oversight of Human Stem Cell Research: The California Institute for Regenerative Medicine's Medical and Ethical Standards." It was written by Geoffrey P. Lomax, Zach W. Hall and Bernard Lo.

Hall is the former president of CIRM. Lomax deals with the institute's research standards development. Lo is with UC San Francisco, where he deals with medical ethics. He also serves as co-chair of CIRM's standards working group.

The ESC regulations developed by CIRM broke new ground in some areas and were the most refined in the nation at the time they were promulgated.

The article notes:

"Because other states and jurisdictions may also be developing standards for hESC research, consideration of the principles that guided the CIRM efforts and the innovative measures that it enacted may be useful to others."

One of the excellent attributes of the piece is that it is not hidden behind a private Web site that costs hundreds of dollars to access. It can be found gratis at the www.plosmedicine.org.

Fresh Comments

Lawrence Ebert has posted a comment on the $220 million item. Don Reed has posted a comment on Canadian-California item. Thanks, Don, it is nice to be back in the Old Country.

The $220 Million Lab Giveaway and Its Rules

Scientific laundromats, silos and collaboration benches.-- all were part of the discussion Thursday as the California stem cell institute began developing its criteria for giving away $220 million to build major research facilities.

The meeting was unusually well attended, with the audience easily exceeding the size of those usually at CIRM's Oversight Committee meetings. The actual numbers, however, were less impressive – something slightly over 30.

They were there because they represented universities and others hoping to win multimillion dollar grants to build new science complexes. USC(at least six representatives)UC San Francisco (at least two), Stanford(at least two), Children's Hospital of Oakland(one), UC Berkeley(two), UC Davis (one), UC Irvine (one) all were on hand.

The CIRM Facilities Working Group, which makes recommendations on lab grants, heard some interesting suggestions during the presentations and questions following.

Robert Klein, chairman of CIRM, several times said he expected some applicants to match the grant amount 100 percent, well exceeding a possible nominal match requirement of only about 20 percent. Also surfacing during the discussion was the suggestion that applicants who could line up major contributions – in kind or cash -- from industry might also be more favorably regarded. Other possible industry linkages could be important as well.

Some of the additional questions surfacing directly or indirectly: Is there going to be an effort to spread the grants around the state? How can smaller institutions compete successfully? Will there be more than one round of grant applications?

Irv Weissman, Stanford's eminent stem cell researcher, told the group, "You will be beset by all sorts of political and geographic forces."

"People will try to fool you," he said.

Weissman and others urged an emphasis on excellence. He said the track record of the institutions and their scientists is the best way to assure that.

Jeff Bluestone, director of the UC San Francisco Diabetes Center, also emphasized excellence. He and Weissman additionally spoke of the need to prevent scientists from becoming isolated in "silos" in the proposed labs.

"Successful buildings are ones that have people bumping into each other," Bluestone said.

At one point, CIRM Oversight Committee member Janet Wright used the expression "scientific laundromats" to describe space that can allow for informal research exchanges.

Weissman offered up collaboration benches as one way of bringing in researchers from locations that do not have facilities that match those of major institutions.

Jeff Sheehy, a CIRM Oversight Committee member, said he was interested in providing for opportunities for many institutions.

"Everybody should get a fair shot at attempting to do stem cell research in California," he said.

Thursday's hearing in San Francisco was the first of four. The next will be Monday in Los Angeles, the third June 11 in Sacramento and the fourth in San Diego June 19. You can find more information here and here.

Grant applications are expected to be solicited this August with grants awarded early next year.

Needless to say, it would behoove any institution that expects to seek building grants to attend and participate in these meetings. They offer an opportunity to shape the criteria but also can provide insight into the thinking of some of the players who will be making decisions on who receives the money.

CIRM Legislation Now on Senate Floor

Legislation to ensure a fair return to California from products developed as the result of state-funded stem cell research has moved to the floor of the state Senate, where it faces a major challenge for passage.

The bill, which is also aimed at ensuring affordable access to state-funded stem cell cures, must gain a super, super-majority vote to win approval in the Senate. The requirement for a 70 percent vote was written into the state Constitution in Prop. 71 by stem cell proponents who wanted to make it difficult for elected officials to fiddle with the $3 billion research effort.


The bill, SB771, cleared the Senate Appropriations Committee on Thursday after the Democratic Senate leadership approved its removal from a "suspense" file.

It is not known when the measure by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley, will come up for a vote in the Senate.

The Canadian-California Stem Cell Treaty

California Gov. Arnold Schwarzenegger did not exactly blow the dome off the Capitol -- newswise -- with his stem cell announcement in Canada yesterday.

Coverage was minimal. Perhaps the most details can be found on the governor's web site. California stem cell Chairman Robert Klein, who traveled to Canada as part of the governor's party, is also featured there with a video blog on stem cell matters.

Some excerpts from the governor's statement:

"(Ontario Premier)Premier McGuinty announced the formation of a new Cancer Stem Cell Consortium that will bring together the best minds and resources in California and Canada to fight cancer through stem cell research.

"This project was initiated by the stem cell and regenerative medicine working group of the Canada-California Strategic Innovation Partnership, a unique collaboration between California and Canada stakeholders from academia, the private sector and government."

"The Ontario Institute of Cancer Research will donate the first $30 million (Canadian) to fund the Consortium, benefiting both Canadian and Californian researchers."

"UC Berkeley's Stem Cell Center and Canada's International Regulome Consortium will coordinate research and take advantage of each institution's expertise."

The CIRM Budget and Burger King

The California stem cell agency plans to nearly double its staff during the next 12 months or so.

That means it will grow from tiny to not-so-tiny. In other words, from 24 workers to 41.

The additions are much needed. Beleaguered might be too strong a term to apply to the staff, but it probably was appropriate on some days during the last two years.

The additions are part of the budget approved earlier this week by CIRM's Governance Committee. The spending plan totals about $8 million for administrative functions, up from about $7.3 million for the current fiscal year, which ends June 30. The full Oversight Committee is expected to approve the proposal next week in Los Angeles.

CIRM is already seeking applications for the following positions: president, associate legal counsel, grants management officer, grants management specialist, grants technical assistant and scientific program and scientific review officers.

The agency will also see a substantial decrease in costs related to the now finally finished litigation, but CIRM will add $200,000 for legal work related to intellectual property issues.

Lest you fear that CIRM is on a path of rampant bureaucratic growth, Prop. 71 capped the number of employees at 50 to administer the $3 billion research effort. We would have to check, but it is probably fewer than it takes to run a Burger King.

CIRM Legislation: A Cash Cow or Bum Steer?

Legislation to ensure that California garners a decent return on its $6 billion investment in embryonic stem cell research has hit a roadblock and faces a critical hearing on Thursday.

The measure is SB771 by Sen. Sheila Kuehl, D-Santa Monica, and Sen. George Runner, R-Antelope Valley. Kuehl is chair of the Senate Health Committee and Runner is the No. 2 GOP leader in the Senate.

The bill has been shunted into a "suspense" file, along with many others, because the chair of the Senate Appropriations Committee, Tom Torlakson, D-Concord, is uncertain whether the measure would generate more revenue than would the regulations of the California stem cell agency itself.

If the measure is not removed from the suspense file, it will be placed on hold for this year and is not likely to be brought up again until January.

Discussions have been underway between Kuehl, Torlakson, Senate President Pro Tem Don Perata, D-Oakland , and Senate Majority Leader Gloria Romero, D- Los Angeles, about the fate of the bill. Kuehl and Runner are contending that it is impossible to make revenue comparisons between the bill and CIRM regulations because the regulations are not in final form. They also argue that arguments by the biotech industry concerning the adverse impact of the bill are highly speculative. Industry is also not fond of CIRM's rules.

Although the Kuehl bill is up for a nominal public vote, without a nod from the Senate leadership, the bill is not likely to be removed from the suspense file.

The staff of the Appropriations Committee has prepared an interesting analysis of SB771 that indicates that the measure would generate $56 million more for the state over a given period than would CIRM's regulations. Here are some excerpts:

"Based on a direct comparison of state revenues generated under SB 771 and under the CIRM regulations, SB 771 would produce more revenue than the CIRM regulations. In a ten year projection of a sample project modeled under three scenarios (a licensed invention, a low success royalty, and a high success royalty) with an $8 billion public investment, SB 771 would have produced $183.5 million compared to $127.7 million under the CIRM proposed regulations.

"The California Institute for Regenerative Medicine believes that the sample comparison above is misleading, that financial market forces, the interests of private research companies, and the unique nature of cellular therapies will produce disincentives which will substantially reduce the projected returns of 771."

The analysis said it reviewed economic studies of potential Prop. 71 returns although it did not cite them by name. It said the studies projected royalties to the state of between $160 million and $1.1 billion.

Earlier this month, an item appeared on the Internet that bears on the biotech industry position that anything that promises to inhibit returns on stem cell products (such as SB771) will discourage research. In an item called "What Price Innovation?," Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest, wrote about industry arguments that Democratic national health care reform plans would choke medical research. Goozner said:

"Is there any evidence to suggest that the pace of significant medical breakthroughs can be associated with higher drug industry sales, profits, profit margins or, perhaps most significantly, R&D expenditures? Or, put another way, given the past decade's very high rates of sales growth, profit growth and R&D expenditure growth, how does one explain the steady downward decline (trend line; there is, of course, year-to-year variation) in the number of significant new drugs emerging from industry labs?"

Where's the Money?

Even today headlines talk about the stem cell "gold rush" in California. And it is years after the Prop. 71 campaign financed a study that seemed to promise as much as $1 billion to the state from state-backed stem cell research.

While the headlines may reflect a paucity of imagination on the part of headline writers, the dreams of buckets and buckets of stem cell cash still energize much of the dialogue concerning ESC research.

Jesse Reynolds, writing on the blog Biopolitical Times, recently revisited the subject of stem cell swag. The occasion for commentary was an article in Nature Biotechnology.

Reynolds, who works for the Center for Genetics and Society in Oakland, said what is remarkable about the piece is what's missing. He wrote:

"There’s no reference to the over-the-top -- yet widely-cited -- optimistic scenarios spun in an economic analysis that was widely touted, and funded, by the campaign to establish the (California) state program."

Reynolds noted that Stanford University professor of health research and policy Laurence Baker was a co-author of both the Prop. 71 campaign study and the Nature Biotechnology article, a fact that Reynolds said was not acknowledged in the magazine.

Reynolds said Baker furiously backpedaled from his campaign study. Reynolds quoted the Nature Biotechnology article as saying:

"[A]t this point predicting particular breakthroughs or economic benefits would amount to little more than speculation.... New stem cell therapies will not necessarily reduce [health care] spending; indeed they may drive spending up...Forecasting and even retrospectively assessing the success of Proposition 71's IP provisions will be extremely difficult."

The economic promises of stem cell research are as of much interest today as they were three years ago. Lawmakers are currently struggling to ensure that the state does, in fact, share in any profits. The biotech industry and CIRM are opposed to that legislation (SB771), authored by State Sen. Sheila Kuehl, D-Santa Monica, chair of the Senate Health Committee.

CIRM itself is in the midst of drawing up rules for revenue sharing involving future grants to California businesses. And elsewhere in the country, other states are launching stem cell research efforts, peddling the idea that it can funnel vast economic benefits into the state.

$30 Million California-Canadian Stem Cell Effort

California Gov. Arnold Schwarzenegger is off on a Canadian junket – privately funded – to promote stem cell research and wine, among other things.

According to some reports, he is scheduled to announce, along with Canadian counterparts, a $30 million stem cell research effort involving the Ontario Institute for Cancer Research and a cancer stem cell consortium in Ontario and California.

According to Robert Benzie of the Toronto Star:

"Schwarzenegger will disclose a new project between the University of California at Berkeley and the International Regulome Consortium, led by Michael Rudnicki, scientific director of Canada's Stem Cell Network and director of Ottawa's Sprott Centre for Stem Cell Research."

Beyond that, little was known about the project, although it appears to be an effort worked out between the researchers with the politicians weighing in at announcement time. Schwarzenegger's own Web site did not mention it on its home page this morning, which emphasized the wine aspects of the trip.

The governor's Canadian foray attracted some controversy because it was privately funded with none of the donors disclosed.

Kevin Yamamura wrote in The Sacramento Bee about the private nature of the trip, although he did include a list of some of the top corporate executives accompanying the governor.

Yamamura quoted Bob Stern, president of the Institute for Governmental Studies in Los Angeles, as saying,

"Why can't the state pay for it? It just looks wrong. Basically, you're having special interests pay for the trip. If taxpayers were paying, we'd know it's all California-taxpayer related."

We're Back!

The California Stem Cell Report will begin postings anew later today. We have spent much time in the Sea of Cortez and later on land in Mexico, preparing our salty home (a sailboat) for a bit of a rest during the next few months. It may not be much of a rest for us, however. Our major assignment will be to help care for some grandchildren for a bit. The sweet little things aside, you all can look forward to more exciting California stem cell tales beginning shortly.

Hoisting Anchor

The California Stem Cell Report will be on a hiatus beginning Saturday morning. As many of you know, this effort is produced primarily from a sailboat on the west coast of Mexico. We are putting out to sea and will not have access to the Internet – only clear water, hopefully reasonably calm seas and pleasant temperatures – for the next few weeks. Look for resumption of operations sometime after the middle of May. The break also means that comments submitted to the blog, which are moderated, will not be posted while we are wandering about the briny deep.

More Fallout from CIRM's Facilities Meeting

The Friday the 13 meeting of the CIRM Facilities group generated additional coverage in the last few days. That was the meeting that precipitated the early departure of the president of the California stem cell agency. The chair of the Facilities group also resigned without explanation following the session.

On May 2, CIRM's Oversight Committee will meet to deal with the fallout.

Science magazine described CIRM President Zach Hall as "rattled " by the Facilities session. The account was based on the transcript of the meeting. Our reading of the transcript, plus knowledge of the cast of characters involved, does not support that characterization. Some who were actually present also do not agree with the description. Today, by the way, was Hall's last day at CIRM.

The San Jose Business Journal wrote about how the lack of lab space is delaying the development of cures based on embryonic stem cell research. We have not seen the entire piece, but this is a message that will be delivered with some emphasis next week at the Oversight Committee meeting. You may recall that patient advocates are taking a go-slower tack on funding research labs.

Fresh Link

We have added a link to a site operated by Ben Kaplan called Ben's Stem Cell News: All The Latest Stem Cell Research and Science News. Ben and his brother were featured in the "Twins" TV ad for Prop. 71, which can be seen on YouTube. Kaplan reports they recently shot another stem cell video for Current TV which is expected to be aired soon.

Coverage on the Cha Retraction

The latest doings in the Cha affair were reported today in the Los Angeles Times and The Scientist magazine, following the report on this site yesterday that the article in question was being retracted by the journal that published it.

William Heisel of the Times began his story by saying:

"A U.S. medical journal will retract an article that set off an international plagiarism dispute but will take no action against the lead author, a prominent South Korean scientist whose Los Angeles institute is in line to receive state funds for stem cell research."

Alison McCook of The Scientist had a similar story but with less detail.

Duplicate Publication: Journal Retracts Cha Article

The Fertility and Sterilityjournal has apparently retracted on grounds of "duplicate publication" a paper also involved in allegations of plagiarism by Korean scientist Kwang-Yul Cha.

The matter became of interest in California after the state's stem cell agency approved a $2.6 million research grant for a subsidiary of Cha's Korean organization.

Tony Knight, a spokesman for Cha, sent a copy of the press release announcing the journal's action to the California Stem Cell Report. The release, however, does not yet appear to be on the Fertility and Sterility journal web site. We have queried the journal concerning the information, which did not address the plagiarism allegations.

Here is the statement from Fertility and Sterility as relayed by Knight. A statement from Cha Health Systems follows along with a link to a piece in The Scientist magazine today on the matter.

"For immediate release: April 26, 2007

"The December 2005 issue of /Fertility and Sterility/ included an article entitled “Quantification of Mitochondrial DNA Using Real-time Polymerase Chain Reaction in Patients with Premature Ovarian Failure.” The article was originally published in the /Korean Journal of Obstetrics and Gynecology /(/KJOG/) in 2004, under a different title, with some authors different from those listed in the publication appearing in /Fertility and Sterility/.

"Based on the prior publication of the article, which is contrary to the standards of /Fertility and Sterility/ and medical and scientific publishing, /Fertility and Sterility /has decided to retract the article and will publish that fact in an upcoming issue of /Fertility and Sterility/. This decision was based only on the issue of duplicate publication and does not reflect on the scientific validity of the paper.

"Dr. Sook-Hwan Lee was listed as corresponding author of each version of the article. Dr. Lee has admitted responsibility for the duplicate publications of the article and states that none of the other persons listed as authors had knowledge that the article submitted to /Fertility and Sterility/ had been previously published in KJOG.

"After carefully considering the facts available to it, /Fertility and Sterility/ has determined that Dr. Lee will not be allowed to publish materials in /Fertility and Sterility/ for the period of three years. No action will be taken as to any of the other persons listed as authors of the /Fertility and Sterility/ article, Kwang-Yul Cha, MD, PhD; Hyung-Min Chung, PhD; Kwang-Hyun Baek, PhD; Sung-Won Cho, MS, and Kyu-Bum Kwack, PhD."

The Cha Health Systems statement said:

"The (journal) said its decision to retract the article was based only on the issue of duplicate publication. We were hopeful that the paper would not be retracted, but we are pleased that the board recognized its scientific merit. We have said from the beginning that Kwang-Yul Cha, MD, PhD; Hyung-Min Chung, PhD; Kwang-Hyun Baek, PhD; Sung-Won Cho, MS, and Kyu-Bum Kwack, PhD. knew nothing of the paper’s prior publication. We are gratified that the /F&S/ board reached the same
conclusion."

The Scientist magazine article on the matter did not contain information on the journal action, but said it had not made a decision on how to handle the plagiarism issue.

CIRM Legislation Advances in State Senate

The California State Senate Judiciary Committee today approved legislation aimed at ensuring that the state receives a return on its $3 billion stem cell research investment and that its citizens receive affordable treatments with any state-financed stem cell cures.

The measure, SB771, was sent to the Senate Finance Committee, its last stop before it reaches the Senate floor.

Sen. Sheila Kuehl, D-Santa Monica, told the committee that her bill merely "keeps the promises" of the Prop. 71 campaign. Sen. George Runner, R-Antelope Valley, co-author of the measure, said it ensures that the campaign was not a "bait-and-switch" effort. Runner also said it was "perplexing and disappointing" to hear opponents of the legislation complain that it would stand in the way of development of cures.

The measure was opposed by CIRM and the biotech industry as represented by the California Healthcare Institute. Their arguments were familiar to those who have read these pages and can be seen in much greater detail in items elsewhere on this Web site than time allowed in today's 15-20 minute hearing.

Kuehl said she was willing to work with CIRM but was not satisfied with its position that the legislation is premature. She the use of the "trust us" argument "is not attractive to me." She also noted that industry sounds as if it has a problem keeping the promises embodied in the Prop. 71 campaign.

Representing CIRM at the hearing was Francisco Prieto, a Sacramento physician and a member of CIRM's Oversight Committee. He reiterated CIRM's position that the legislation was premature and said the agency was making progress in meeting the promises of Prop. 71. Runner indicated that "premature" was not necessarily the appropriate term since the agency has been in place for nearly 2 ½ years.

(For more on the legislation, use the search function in the upper left hand corner of this blog or click on the labels below.)

Correction

The item below incorrectly stated that SB771 would go to the Senate floor after clearing the Judiciary Committee. The bill actually goes to the Finance Committee and then to the floor, if approved by the committee.

Kuehl Legislation Up for Hearing This Afternoon

Legislation aimed ensuring a return on California's $3 billion stem cell research effort and affordable access to state-financed cures is scheduled to be heard this afternoon in a state Senate committee hearing that can viewed live on the Internet.

The measure by Sen. Sheila Kuehl, D-Santa Monica, is on the agenda of the Judiciary Committtee, its last stop before it could move to the Senate floor. The session begins at 1 p.m. PDT today. It can be seen on Calchannel.com. We recommend that you check in earlier to be sure your computer is properly configured to see the action.

The Foundation for Consumer and Taxpayers Rights Monday said the legislation is laudatory but falls short in guaranteeing affordable access to stem cell therapies funded by CIRM research. The measure is opposed by CIRM and the biotech industry.

The foundation said in a letter to legislators written by John M. Simpson, its stem cell project director:

"Foremost among the positive aspects, the bill clearly establishes that the Legislature has an appropriate role in oversight of the state’s stem cell institute, the California Institute for Regenerative Medicine. It requires intellectual property regulations that provide for a fair and reasonable financial return to the state on any discoveries made as a result of state financing. It also requires price discounts for drugs, therapies and diagnostics purchased with public money and that organizations receiving licenses provide reasonable access to therapies, drugs and diagnostics for uninsured Californians.

"However, SB 771 contains no provision ensuring that all Californians will gain affordable access to the results of the research they have funded. No one begrudges a company a reasonable profit. What must be prevented is egregious profiteering when public funds have been used to develop a therapy, drug or diagnostic.

"I wish this were only a hypothetical issue; it is not. Genentech’s lifesaving cancer drug Avastin was launched with the benefit of $44.6 million in public funding. Nonetheless, the company originally priced the drug at $100,000 for a year’s supply. Only after months of outrage has Genentec capped Avastin’s price at $55,000 a year.

"SB 771 needs a provision that would prevent this sort of abuse when public funds help produce important drugs and therapies. The Attorney General must have the power to intervene and reduce prices in similar cases."

Fresh Links and More

We have made a couple of modest changes on this Web site to help readers. They include links to background information on the California Stem Cell Report as well as its financial disclosure. Also added is a link to a short item telling how to search the blog more effectively. A link to the Americans for Stem Cell Therapies and Cures is now included, and the link to the Genetics Policy Institute has been fixed. If you have suggestions for additional links, please send them to djensen@californiastemcellreport.com.

The $222 Million Question and CIRM's Direction

The directors of the California stem cell agency will come to grips on May 2 with the abrupt departure of its president and a related acrimonious flap involving its plans to give away – or not give away -- $222 million for research laboratories.

The public will have a unique opportunity to hear and comment on those matters during the first-ever conference call meeting of CIRM's Oversight Committee. Locations are available in many areas of California where persons can listen to the session or make comments. Three in San Francisco, two each in La Jolla and Irvine and and one each in Los Angeles, Sacramento, Carlsbad , Stanford and Duarte. You can find the specific locations on the agenda.

The 29-member committee is scheduled to consider the appointment of an interim CIRM president, probably somebody from within the existing staff. It will also have to find a new chair for the Facilities Working Group.

The May 2 meeting was called after CIRM President Zach Hall moved up his departure date from CIRM two months following a contentious meeting of the Facilities group April 13. The chairman of that group also quit, resigning with no explanation.

Also on the agenda is the go-slow motion from the Facilities group on grants for major labs. The motion was unanimously adopted on April 13 by the Facilities group, which is dominated by patient advocate members of the Oversight Committee. The motion seemed to fly in the face of opposite direction from the full Oversight Committee just three days earlier. The Oversight Committee basically approved the schedule for the grants last year as well the dollars when it approved its strategic plan. However, votes can change.

Nominally nine patient advocates sit on the Oversight Committee but two also have significant ties to institutions that could benefit from lab grants. Fourteen Oversight members, including two patient advocates, have significant ties to institutions that could stand to benefit from lab grants. Here is the list of members.

CIRM's Facilities Meeting: 'Not So Terrible'

The contentious Friday the 13th session of the Facilities Working Group of the California stem cell agency triggers different reactions from different folks. We queried John M. Simpson, stem cell project director of the California Foundation for Taxpayer and Consumers Rights, about his impressions. Here is his reply.

"I've finally read the transcript of the FWG meeting. I actually didn't think it was so terrible.

"Yes, there were 'full,fair,frank exchanges of views' as the diplomats would say, but I thought the meeting got to what is a fundamental split on the question of how to award facilities grants-- or indeed if any should be awarded.

"I think all too often the academics and research institution representatives on the ICOC have exhibited almost a sense of entitlement to CIRM money.

"I am delighted to see members of the Facilities Working Group voicing their sense of responsibility to California taxpayers to be good stewards of CIRM funds. They are taking their responsibility seriously and should be commended for that.

"I'd also add that on the issue of making facilities grants, the academics are clearly conflicted.

"Deliberate speed is appropriate, but the emphasis must be on deliberate – not on speed for speed's sake."

Fresh Comments and Ariff Bongso

Lawrence Ebert, David Hamilton and Karl Bergman have all filed comments on the "Snippets" and "WARF News" items below. Some of them involve a story by Terri Somers of the San Diego Union-Tribune that we should have mentioned earlier. She wrote about how Ariff Bongso of the National University of Singapore in 1994 became the first scientist to derive human stem cells from an embryo.

Her story said:

"In the process, he laid the foundation for a field that many people hope will lead to new therapies for diseases such as diabetes, Parkinson's and cancer – and that others oppose because it destroys embryos.

"'Bongso made the connection between his area of expertise, human embryology, and stem cells, and just went for it' said Jeanne Loring, a stem cell researcher at the Burnham Institute for Medical Research in La Jolla. 'That's how great scientific discoveries are made, for the sake of curiosity.'

"But Bongso never patented his work.

"For almost a decade, the fame and financial benefit of being the first to derive human embryonic stem cells has been heaped upon James Thomson and the University of Wisconsin."

CIRM Facilities Rancor: Delay and Dollars

Contentious, personal, confrontational, sarcastic – all could accurately describe last Friday's session of a key group of the California stem cell agency.

But, based on the transcript, the descriptions miss what was fundamentally important about the meeting and also what was hardly said. And that is: The agency is not required to spend $300 million on bricks and mortar – the major labs so desired by California research institutions. It is merely authorized to do so. And delaying them could mean more money for other endeavors.

The meeting of the Facilities Working Group was cited by CIRM President Zach Hall in his letter announcing that he was stepping down early. (See "Edifice" below.) The nominal topic of the meeting involved the laying more of the groundwork for $222 million in grants for major research facilities at California universities and nonprofit institutions.

But by the end of the acrimonious session, the Facilities Group, dominated by patient advocates, had set the stage for a major debate within the CIRM Oversight Committee. Three days prior to the Facilities meeting, patient advocates had lost a straw vote within the 29-member Oversight Committee for a more modest proposal for a written survey instead of the public hearings approved by the Facilities group. A seeming routine matter that was freighted with major baggage, including who is in charge – the Oversight Committee or its advisory groups?

Other issues emerged as well. The Facilities meeting highlighted the difficulties that any organization faces when it tries to operate without a "permanent" CEO. Hall was already a lame duck at the time of the meeting, having announced his departure last December. The session also demonstrated persistent divergence about the role of the CIRM president. Oversight Committee Chairman Robert Klein insisted that Hall execute the wishes of the Facilities Group even though Hall believed they conflicted with the Oversight Committee.

Finally, there were questions of the balance between making grants with great speed and exercizing due diligence.

Prop. 71, which altered the California Constitution and created CIRM, provided for spending as much as $300 million on laboratory facilities. If the agency does not spend all of the sum, the remainder could go for more direct development of cures and therapies, a high priority for patient advocates who sit on the board. At the same time, top executives from California universities sit on the Oversight Committee. Their view is that they do not have enough room for existing researchers, much less the ones that are being recruited to come to the Golden State to perform embryonic stem cell research financed by CIRM. Construction costs are spiraling upward, and any grants will buy less in 12 months than they do today.

Prolonging the grant process could, however, mean that more funds would be ultimately available for patient advocate-backed research. Unwilling to wait, institutions will find other funding sources. Needs will change. Grant criteria could become more strict, ruling out some institution's plan. Some projects may become prohibitively expensive because of rising construction and equipment costs.

No one on the Oversight Committee is talking publicly about such a delaying strategy but it is clearly viable. And it is one that is not likely to be regarded kindly by institutions represented on the panel.

At last Friday's meeting, Hall said that the Oversight Committee had indicated a need for speed in moving grants forward and that he was receiving the opposite instructions from the Facilities Group. He said his first responsibility was to the full Oversight Committee. Hall said,

"I feel it is very important that it be worked out at the highest governance level for this whole organization, which is the board. I think that is the key. This is a really important issue here, and there's a, I would even say, a cultural difference between those involved in the scientific culture who see the need, who understand the urgency, and who are trying to move this forward in order to get the whole project going, and those here whose point of view I have heard(at this meeting)."

Oversight Committee member Marcy Feit, CEO of Valley Healthcare Systems, said she did not detect the same urgency as Hall. She said,

"This is a public agency with taxpayer dollars. And we are foolhardy if we don't pay attention to our responsibility. But nowhere on that (April 10) board meeting did I hear any board member not encourage us to do our job. So I would beg to differ with you that there is a cultural difference. There is not a cultural difference. I think if there were the rest of the board members here today, they would agree with us."

James Harrison, CIRM's private counsel, said,

"Zach is correct, that the ICOC expressed its intent that gathering information through a survey or through some prenoticed letter was not necessary or desirable in light of the sense of urgency that was expressed."

Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group and author of the public hearings motion, said it would not mean a delay in approving grants. In response to a query, he said in an email,

"Will undertaking a deliberative approach cause a delay? No, it will not. The Facilities Working Group can do its thing and meet the deadline, but it will need the support of the president to make it happen. That's where things got a little tense (see item below)."

To resolve the $222 million worth of edifice issues plus the question of who will be in charge of CIRM beginning in May, the institute is attempting to set up a special meeting of the Oversight Committee as soon as possible. The meeting is likely to be in the form of a conference call.

The committee will be operating in an atmosphere damaged by the rancor of last Friday's Facilities meeting. For a closer look at the acrimony, see the item below.

A Friday Filled with Acrimony

"Time out. Time out," said Rusty Doms, chairman of CIRM's Facilities Working Group, at one point as the discussion threatened to wheel out of control.

It was a conference call meeting last Friday that CIRM President Zach Hall later cited as one reason for his early departure as head of the $3 billion institute. Dom also resigned, submitting a terse letter with no explanation.

On the agenda was the topic of how to give away $222 million for embryonic stem research facilities.

The contentious discussion went on for some length. Questions of responsibility, due diligence, consideration of the public interest, loss of purchasing power, conflicts of interest and more surfaced.

At one point, Oversight Committee member David Serrano-Sewell, vice chair of the Facilities Group, repeatedly demanded that Hall answer a question with a yes or no. It related to a motion, authored by Serrano-Sewell, for public hearings on research lab needs. The motion had just been unanimously approved by the group.

Hall said that the vote contradicted the position of the Oversight Committee three days earlier. This exchange followed, according to the transcript of the meeting:

Hall: "Now, given the unanimous vote of this working group, there is no – I think there's no point in us doing that(preparing an outline for a major facilities RFA for the June Oversight Committee meeting). It's very clear, but it's also very clear to me that there are two different points of view represented on the ICOC(Oversight Committee)."

Serrano-Sewell: "Zach, it's a simple question. yes or no? Before the June meeting, will you aid this working group in a hearing?"

Hall: "I will."

Serrano-Sewell: "Yes or no? Will you assist this working group?"

Hall: "I want direction from the ICOC about how we should proceed on this."

Serrano-Sewell: "I'll take that as a no. If you're not helping us before the June meeting by committing resources, saying, yes, working group, I will commit resources, I will commit time in aiding you setting up these hearings which you unanimously passed."

Hall: "I'm sorry."

Serrano-Sewell: "It's either a yes or a no."

At this point, Hall said it was a matter that needed to be worked out by the full Oversight Committee and reflected a cultural difference within that group.

More sharp exchanges can be found in the transcript. But care should be taken in the reading. It was a conference call situation. Tone of voice, facial expressions (where the participants were together) are all missing. And there may transcribing errors, which can occur because of the difficulty in hearing all participants.

One such error seems to involve a quote for Serrano-Sewell. In the transript, he is quoted as saying, "I wanted to create a constitutional crisis." We queried him about the remark. He said he recalled saying that he did NOT want to create a crisis.

CIRM Presidential Search: Semi-finalists in June

CIRM's presidential search committee met Tuesday only a few hours after President Zach Hall announced he was leaving early. Filling his vacancy has now become a more urgent matter.

John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumers Rights, monitored the conference call meeting. We asked him for his impressions. Here is what he sent.

CIRM is on a fast track to name the next president.

Tuesday's public session of the search committee meeting was short.

Lisa Piper (of the SpencerStuart search firm) gave an overview of the search process and said that SpencerStuart had gathered 450 names "using a variety of media including e-mail, phone and letters." There were also about 80 nominations.

From that pool SpencerStuart culled a "long list" of a dozen or so candidates that were to be discussed by the committee in the closed session. Plans were to cut that list to a short list of four to six candidates.

SpencerStuart would then interview and prepare reports on all on the short list for two-days of interviews by the search committee on May 11 and 12.

The plan is to select semi-finalists from the short list for presentation to the board for consideration at the June ICOC meeting.

I asked if Zach Hall's departure would have any impact on the time line. Most of the committee members did not seem to be aware of his early resignation.

Bob Klein responded by saying that CIRM had been run by an acting president and acting chief scientific officer when Zach was recently on vacation. The best course would be determined, he said, "in consultation with CIRM's senior staff to see what the proper solution would be."

"I am sure they will carry on in the tradition of excellence established by Dr. Hall," Klein said.

Wright: 'Not The Best Day'

More details emerged today on the heated, Friday the 13th session concerning the California stem cell agency's plans to give away $220 million for major research labs and buildings.

The meeting involved CIRM's Facilities Working Group, which is laying the groundwork for dispensing the funds (see the item below). At issue seemed to be questions of how much time and information was needed by members of the group before the grant applications went out. CIRM President Zach Hall characterized the meeting as "exceedingly contentious and personal" in a letter announcing his early resignation.

The session was not covered by the media, and a transcript is not yet available. So reporters prepared stories that were published today based on what some of the participants recalled in the wake of the resignation letter by Hall. That reconstruction process is common in the news business but always carries a certain amount of risk.

Reporter Terri Somers of the San Diego Union Tribune wrote:

"Dr. Janet Wright, a cardiologist who is a member of the (CIRM) board, said she couldn't believe the tone of contention, sarcasm and aggression toward Hall at the meeting.

"'I still don't know the gist of the attitude or tone, or where it was coming from,' Wright said. "I was so surprised by the tone, I couldn't seem to recover enough to call attention to it and try to set things right."

"Working group members David Serrano-Sewell and Jeff Sheehy acknowledged that they 'passionately' disagreed with Hall's stance at the meeting, but did not mean to be contentious or disrespectful.

"'I have nothing but the utmost respect for him. We couldn't have done all we've done without him,' said Serrano-Sewell, the working group's vice-chairman.

Somers continued:

"(A)t a meeting three days earlier, the full institute board had rejected a request by working group members, including (CIRM Chairman Robert) Klein, to survey possible grant recipients and others about their facilities proposals.

"As a result, Hall on Friday tried to push the working group to skip the information gathering and move directly to details of the grant applications....

"But the working group members voted unanimously for more information gathering, similar to the public hearing process that was used in developing the institute's standards and ethics policies and its strategic plan."

Carl Hall of the San Francisco Chronicle quoted Sheehy as saying:

"Zach identified a cultural divide that existed between the scientist members and the patient advocates, and he didn't want to straddle it anymore."

The stories also included the resignation of the chairman of the Facilities Working Group in the wake of the session. Rusty Doms, a Southern California developer, turned in a brief letter that did not cite any reasons for his departure. The letter was dated Sunday April 15, just prior to the announcement of Hall's resignation.

Jim Downing of The Sacramento Bee wrote:

"Bob Klein, the chair of the governing board, said Doms told him he was resigning principally because he did not have time to attend the series of meetings that Wright and others proposed. Doms is also on the board overseeing the construction of a major new hospital in Los Angeles, Klein said."

Somers said that one member of the public was uncomfortable with what occurred at the meeting, She wrote:

"'You can choose to agree or disagree, but the tone with which Zach Hall was treated was not the way you want to treat a president that accomplished so much for the (California Institute for Regenerative Medicine),' said Dan Oshiro, vice president of administrative affairs at the Gladstone Institute in San Francisco. The working group meeting was the first Oshiro had attended."

Downing of The Bee quoted Oversight Committee member Wright as saying,

"It was not our best day."

The $200 Million Edifice Issue

The resignation letter released earlier today by CIRM President Zach Hall referred to a more than $200 million edifice issue that now embroils California's stem cell agency.

What's at stake are huge grants for building projects at universities and nonprofit facilities throughout California. CIRM is currently involved in laying the groundwork for the grants, many of which will go to institutions whose leaders serve on the very board that will make the decisions about which receive money and which don't.

The key CIRM committee in preparing the criteria for the grants is its Facilities Working Group, which met last Friday. Hall's letter said the meeting was "exceedingly contentious and occasionally personal." He also said it was clear that there was a strong desire in the working group for a longer approach to the generating the grants than he was prepared to direct.

John M. Simpson, stem cell project director for the Foundation of Consumer and Taxpayer Rights, said in a press release that "Hall's health should be a primary concern, but clearly there are substantial disagreements at stake here. It's never a good sign when an agency's chief executive leaves after a policy dispute."

Hall declined to comment further on the remarks in his letter. The April 13 meeting was not covered by the media, and its transcript is not yet available. But based on responses from some Oversight Committee members at the meeting, it seemed to involve at least some of the issues that surfaced at a meeting of three days earlier at a meeting of the Oversight Committee.

The April 10 discussion was a bit unfocused and confusing. But it involved issues of whether additional information was needed before requests for grant applications could be prepared and what sort of building plans were underway at various institutions. Some Oversight Committee have pressed for continued speed in making grants. Others, in this case, said they needed more information.

Stem Cell Chairman Robert Klein called for a "straw vote" on whether CIRM staff should conduct a survey of California institutions about their stem cell related building plans. The transcript shows that the vote for a survey failed, but no actual vote was announced.

David Serrano-Sewell, an Oversight Committee member and vice chair of the Facilities Working Group, noted, however, that a majority of that group wanted the survey.

At about that point, Klein moved on to other issues before the Oversight Committee.

We queried some of the members of the Facilities group, which also includes persons who are not on the Oversight Committee, about Hall's remarks concerning the "exceedingly contentious" nature of the later Facilities meeting.

One said that Hall "got crosswise" with some of the patient advocate members at the Facilities group meeting.

Another member of the group said,

"There was some 'heated' adult conversation. Not contentious or personal, at most, it was passionate and spirited. I think the record, once published, will speak for itself. Zach did a lot of good and has alot to proud of."

The transcript will certainly help clarify what exactly transpired. But such documents also do not convey a complete picture of an event.

Hall clearly felt that what occurred was unusual and a cause for concern. It also comes at a time when much is at stake for medical school deans and others whose employers stand to benefit from the massive building grants. That is not to mention that the agency is in the midst of a search for a new president (Hall had already announced his intention to leave in June). Meanwhile the fledgling and tiny CIRM staff must continue to maintain a steady course without a permanent president and no indication when a new one might come aboard.

(On a personal note, Hall's health is the primary concern. We wish him a speedy recovery and all the best.)