Weak Case Made by CIRM Opponents

It has been a sow's ear of a stem cell trial.

For a couple of reasons. One is that it lacked drama. Two, the presentation of CIRM's opponents. They have taken their best shot, and it is way off the mark.

We may be wrong, but it appears that their best arguments were made months ago -- before the trial -- and rejected already by the judge.

Today's proceedings did not advance their case significantly and was dominated by CIRM's presentation, which appeared far more professional than the plaintiffs. Although CIRM's counsel had a couple of procedural fumbles with exhibits, it was nothing like the ones that plagued the opposing counsel.

CIRM's foes had an enormous burden. They had to prove that CIRM basically was not a state agency or controlled by the state. Today, Tamar Pachter, deputy attorney general, made point after point that a host of state agencies, ranging from the Department of Finance to the Legislature, can or have messed about in CIRM affairs.

Stem cell Chairman Bob Klein painted a nearly glowing picture of cooperation with the legislature and various state departments. The rocky side of that relationship was hardly touched on by the anti-CIRM people.

Mercifully, the entire affair will be put out of its misery in a couple of days. The state will call one more witness tomorrow, CIRM President Zach Hall. There will be some more haggling over additional evidence, which may require another witness from the plaintiffs to discuss the meaning of IP policy.

The judge indicated that everything could be wrapped up by Thursday. She is proposing written final arguments and only very brief oral closing arguments, if that.

But both sides have made it clear that the case will be appealed. The ultimate resolution looks like sometime next year, as predicted earlier.

Another Recess and Back At It

The following report on the California stem cell trial comes live from the Alameda County courtroom where the legal proceedings are underway. Your comments or questions are welcome as the trial progresses this afternoon.

We are just back from another recess. Bob Klein is off the stand. An official with the state treasurer's office has come and gone. Walter Barnes, chief administrative officer for CIRM, is on the stand. He came to CIRM from the state controller's office. He has been with CIRM since early in 2005. Barnes is detailing how warrants are prepared by state government. As you can tell from this and previous reports, the drama here is overwhelming. The hottest item I have is a hallway tidbit from Klein. He said CIRM had to produce 37,000 pages of documents for the folks who are suing to eliminate the agency. Stand by for more exciting reports.

Break Time Again

The following report on the California stem cell trial comes live from the Alameda County courtroom where the legal proceedings are underway. Your comments or questions are welcome as the trial progresses this afternoon.

We have just broken for a mid-afternoon recess. The plaintiffs are looking for a document that they say they haven't read. But they want to question Bob Klein about it. Attorney David Llewellyn became a tad more animated a few minutes ago as he pressed Klein on whether there were any guarantees that the state would earn any royalties from stem cell inventions financed by CIRM. Klein said no.

Lunch is Over

The following report on the California stem cell trial comes live from the Alameda County courtroom where the legal proceedings are underway. Your comments or questions are welcome as the trial progresses this afternoon.

Robert Klein continued his testimony following the lunch break. More discussion of CIRM documents continued. Klein answered questions about CIRM's intellectual property and ethical policies. He also discussed selection of working group members. He said the selection process started with 800 names. Media attention is way down today. The San Francisco Chronicle and San Diego Union-Tribune are here. No TV, however.

Stem Cell Trial Recesses for Lunch

The following report on the California stem cell trial comes live from the Alameda County courtroom where the legal proceedings are underway. Your comments are or questions are welcome as the trial progresses this afternoon. .

The California stem cell trial has recessed for lunch until 1:30 p.m. Tamar Pachter, deputy attorney general, will continue questioning stem cell chairman Robert Klein this afternoon. In his most recent testimony, Klein said that Oversight Committee members bring valuable expertise and knowledge to CIRM as the result of their backgrounds, which the plaintiffs contend create insurmountable conflicts of interest. Pachter is attempting to show that CIRM operates within the framework of state government and is a constitutional agency.

Klein Testifying About State Control of CIRM

Stem cell chairman Robert Klein is testifying this morning about how CIRM has worked with other state agencies, from the treasurer's office to the legislature. The line of questioning is being pursued by Tamar Pachter, deputy attorney general, in an effort to show that state oversight of CIRM does, in fact, exist. One contention of the foes is that CIRM operates so independently that it is unconstitutional. Klein has testified that the legislature, controller's and treasurer's offices and governor's office have all participated in developing various procedures and policies at CIRM.

Foes Probe Conflicts of Interest

Opponents of the stem cell agency this morning finished questioning stem cell chairman Robert Klein -- at least for the time being. Tamar Pachter, deputy attorney general, has just picked up questioning of Klein. CIRM foes focused this morning on conflict of interest, particularly in working groups. Largely the testimony was factual, dealing with requirements of rules and how the policy works. CIRM opponents contend that conflicts of interest are so great within the agency that it cannot operate as a constitutional state agency. They also contend that the CIRM working groups actually make decisions not recommendations. So far testimony has not proven that allegation.

Stem Cell Trial Resumes This Morning

The California stem cell trial has resumed this morning in Alameda Superior Court. Stem cell chairman Robert Klein is back on the witness stand and is being questioned by attorney David Llewellyn concerning the meaning of Prop. 71. We are filing directly from the courtroom as Klein testifies. Your comments and questions are welcome throughout the day.

Fumbling Marks First Day of Stem Cell Trial

It was a $6 billion playbill, but if you wanted good theater, you couldn't find it on Monday.

At issue is the existence of the California stem cell agency, which some conservative and Christian right organizations are seeking to terminate.

Their basic contention is that CIRM, created by voters through approval of a ballot initiative in a constitutionally authorized process, is actually unconstitutional because the agency is purportedly not under the control and exclusive management of the state.

The case of the CIRM foes moved slowly on Monday with fumbling over exhibits and evidence, tedious readings of long and short documents and a lengthy opening statement that tested the patience of Alameda Superior Court Judge Bonnie Lewman Sabraw.

No new ground was broken and about the only surprise was that the plaintiffs said they would base their case solely on exhibits.

Late in the day, they summoned stem cell chairman Robert Klein to answers questions about the meaning of CIRM documents. One series of questions attempted to clear up whether he was responding for CIRM, the Oversight Committee or simply as chairman. Another line of questioning, ultimately dropped, involved the meaning of "categories" and "programs."

At one point, attorney David Llewellyn, representing the California Family Bioethics Council, read a segment of the ballot analysis of Prop. 71 to Klein.

"Did I read that correctly," he asked Klein.

"Yes, you read it correctly," Klein responded.

Llewellyn apologized early to the judge for not having his exhibits in order.

Speaking for CIRM was Tamar Pachter, deputy state attorney general, who gave a 15-minute opening statement, the only presentation made by the defense in the day-long proceedings.

She denied that the agency, which will cost California $6 billion, was unconstitutional. She said the voters used their constitutional powers through the initiative process to "tear down barriers" and "strike directly through to their desired end." Pachter said CIRM opponents were using a "tortured interpretation of the (state) constitution" to support their case.

Following the day's proceedings, Mike Claeys of the Alliance for Stem Cell Research said he was "astonished by the lack of coherent arguments" and the "level of disorganization" of the plaintiffs.

CIRM's opponents did seem ill-prepared and poorly organized. But this was day one in the nonjury trial, which is certain to be appealed and ultimately not resolved for another 12 months or so. And a fumbling, country-boy routine may be part of the strategy.

Outside of the courtroom, four Bay Area TV stations collected sound bites from all the principals, including Llewellyn, who sounded crisper and more on message than he was in the courtroom. We understand that at least two radio stations covered the affair along with the usual gaggle of print reporters, but none from out of state.

What appears on TV is not likely to reflect courtroom fumbling, but rather the interviews in the corridors with Llewellyn and his fellow attorneys as well as with Klein and his supporters including four who showed up in wheelchairs.

It is the second venue for CIRM. It needs to win both in court and with the public.

CIRM On The Mark With Media Info

The California stem cell agency moved adroitly last week to stay on top of the media agenda in connection with the beginning of today's trial challenging the very existence of the institute.

Nicole Pagano, a spokeswoman for CIRM, released a notice to the media on Feb. 23 containing the various times, names and basic details of the trial. It was the kind of stuff that rarely makes its way in an obvious fashion into news stories but is quite helpful to reporters, particularly out-of-town reporters and those not well-versed in the issue.

The email notification went beyond those matters to include attachments that will help set the tone of the reporting during the trial and expose reporters to information that they may not have seen until now. The attachments included an 1,862-word rundown on the key attorneys in the case, including the CIRM opponents; a 1,378-word background paper on the organizations involved, again including the CIRM opponents; a 1,796-word timeline on the litigation, and a copy of the 42-page filing by the state on behalf of CIRM.

The material was generally straightforward, quoting from the web sites of CIRM's opponents, even using some of their special terminology such as "the unborn." When sources were not specifically cited, it appeared that the information was the result of pretrial research into the opposing attorneys and their public records.

All of this is quite helpful to reporters, even if they don't use it immediately in stories. The information also has subtle effects that accrue to CIRM's benefit. It tends to make CIRM the lead source for information on the trial and set the agenda for the terms of the public debate about the trial. It tends to create an aura of authority for CIRM, that contrasts favorably to its opponents, at least so far. The information also tends to bolster CIRM's contention that the main motivation of its opponents is religious as opposed to a desire for good government and policy. That kind of background is likely to filter into many news stories.

Providing such information certainly comes under the legitimate functions of any state agency, although some might argue whether it is appropriate for CIRM to release short biographies of opposing attorneys.

Nothing similar was available from CIRM's foes.

As of this writing, the background information is not available on CIRM's website. Presumably, you can receive it by sending an email to npagano@cirm.ca.gov. If that doesn't work, send a request to us, djensen@californiastemcellreport.blogspot.com, and we will forward the information to you.

Coming Up

For those of you who have forgotten, the California stem cell agency goes on trial in the Apricot Capital of the World on Monday. More specifically in Alameda County Superior Court in Hayward, Ca. The nonjury trial is scheduled to begin at 9:30 a.m. Pacific Standard Time. We will be in attendance and will file a report at least by early evening on Monday, perhaps sooner, depending on time constraints and Internet accessibility. Here is a link to a piece Sunday by reporter Paul Elias of The Associated Press, setting the stage for the showdown. Here is another piece by Rebecca Vesely in the Oakland Tribune.

The Wages of Eggs

Cash and human eggs – some folks simply do not want to see them linked together, only reluctantly recognizing that women who donate eggs should be reimbursed for their expenses.

The California stem cell agency recently decided to permit reimbursement for lost wages, a position that troubles California state Sen. Deborah Ortiz, chair of the Senate Health Committee and author of legislation that would regulate egg donations involving non-CIRM funded research.

She cites ethical and fairness issues, among other problems, in implementing a policy of reimbursement for lost wages.

We asked Ortiz' office, via email, for an elaboration on her position, including examples of how reimbursement would amount to coercion or inducement.

Hallye Jordan, director of communications for Ortiz, said the senator's general concern

"is that it would be difficult to establish a fair system for reimbursement of lost wages, particularly when the pool of subjects may include professional women who would be compensated for high hourly earnings and low-income women who may be compensated at minimum wage.

"For a higher income, professional subject, her employer may be able to accommodate her lost time if she is paid by salary. In that case, a credible argument could be made that payment for lost wages that isn't necessary could constitute a monetary reward that goes beyond the 'direct' expenses.

"For women who don't work, or are paid on a seasonal, informal basis, a lost wages policy won't benefit them, anyway. That suggests others steps may be needed to increase diversity among egg donors."

We pursued the question a bit further with Jordan, while noting that the whole question is a bit murky. Here is our subsequent question and Jordan's response.

California Stem Cell Report:
How could a $40,000-a-year woman afford to take off any substantial amount of time if she loses pay? Or even a $70,000-a-year person? Most households in that range do not have the economic slack to accommodate big losses in wages. And workers in that range are not likely to be excused with pay by the employers in order to make egg donations. As for non-working women and seasonal workers, that could be even tougher. A woman who does not work outside of the home makes a genuine, measurable economic contribution to a household. If she is away for any length of time, presumably somebody would have to be paid to perform her tasks.

As for the seasonal workers or informal workers, what "other steps" might be taken? If successful diversity efforts are to be made, something has to be done to recognize the economic situation of persons in minority groups.

Jordan:

"Good points, all. But I don't see how CIRM could pay for lost wages to awoman who has no income. Would they then reimburse her for child care,cooking, cleaning, if she hires someone to take her place in the home? That opens up that whole arena of non-direct expenses, which Prop. 71 prohibits, and (CIRM chairman Robert) Klein said, at the Aug. 30 meeting, includes lost wages. So, all I can say is 'tis a sticky situation."

As Jordan indicates, the final word has not yet been written on this matter. Ortiz' legislation is in its early stages and subject to considerable modification. CIRM itself indicated when it adopted its regulations that it was open to changes. Whether it will go so far as to change the wage reimbursement provision is unclear, but probably unlikely.

Stem Cell Ethics Rules "Flawed"

The Center for Genetics and Society says that the recently adopted ethics standards of the California stem cell agency are "fundamentally flawed" and that its intellectual property rules are unlikely to come close to recouping the cost of the agency's program.

In its most recent newsletter, the center, a longtime critic of CIRM, says,

"While the research standards adopted by the governing board of the California Institute for Regenerative Medicine (CIRM) have some improvements in the details, the core of the policy remains inadequate. It leaves the approval of research protocols to local 'Stem Cell Research Oversight Committees' that will be formed by, and affiliated with, the institutions doing the research.

"These committees will consist largely of stem cell researchers themselves and their colleagues from related scientific fields, whose sympathies and loyalties are likely to lie with their institutions and with the research. Further, there will be no oversight of these committees, and key information will not be available to the public for scrutiny."

The center continued,

"The state's share of revenues under the new policy on intellectual property is unlikely to make a significant dent in the $6 billion cost of the program, and it is far from clear that this huge public investment in stem cell research is the best use of funds to promote the health of most Californians."

The center noted that the campaign for Prop. 71 promised that the program would pay for itself. Of course, those promises were based on a study that the campaign purchased.

The center's newsletter, Genetic Crossroads, provides a useful overview of recent events involving CIRM, including links to other coverage. But it includes many other topics as well. For example, the Feb. 23 edition includes research cloning, a recap of the latest developments in the Hwang affair, coverage of the Schatten case and other stories on related matters in this country and abroad. The newsletter is available by free electronic subscription.

CHI, Stem Cells, Love and Morrow

The California Healthcare Institute made some stem cell news this month with the appointment of a new director to its board and with the involvement of its chief counsel in an faith-based political flap.

CHI, a biomed industry group and supporter of the California stem cell agency, named Ted Love, chairman and CEO of Nuvelo Inc. of San Carlos, a biopharmaceutical firm, to the CHI board of directors. Love is also a member of the Oversight Committee of the California stem cell agency.

Earlier this month, CHI and stem cell research surfaced in a different way in the congressional campaign of Republican state Sen. Bill Morrow. His wife, Barbara, is vice president and general counsel of CHI.

Her connection to CHI became an issue, at least for some, because CHI supports embryonic stem cell research, something that Christian activists oppose.

According to the Agape Press web site, whose motto is "reliable news from a Christian source:

"Senator Morrow does not deny that his wife is employed at the Institute. But he claims her work as general counsel does not require her to promote the company's position on ESCR. The state lawmaker explains that his wife took the job after much prayer and consideration.

"'We sat down with pastors and nationally known bioethicists who were Christians and ministers ... before we accepted that position,' Senator Morrow says.

"Morrow states that he and his wife felt 'very comfortable' with the advice they received -- specifically, that it would clearly understood Mrs. Morrow would not be called on to lobby in support of ESCR. 'And under those conditions, which they've held up to, that's what she's done,' he adds."

Stem Cell Audit Proposal Delayed

Consideration of a proposal to have the legislature's auditor general examine the California stem cell agency has been put off until March 8 or later.

The office of Sen. Deborah Ortiz, who backed the audit along with a bipartisan group of 10 other legislators, announced the delay. No further explanation was offered.

$25 Million for Stem Cell Research and Other Stuff at USC

Funding for stem cell research in California received a big boost today from a self-made billionaire who is the son of Lithuanian immigrants.

The money -- $25 million – is going to USC to create the Broad Institute for Integrative Biology and Stem Cell Research. The institute will be named after Edythe and Eli Broad, who provided the funds through the Broad Foundation.

USC said the 215,000-square-foot facility will be the largest stem cell research center in California when it opens in 2008. The program will involve Childrens Hospital in Los Angeles and teams from Caltech and other regional scientific institutions.

Eighteen new investigators will be involved in the Center for Stem Cell and Regenerative Medicine and another 18 will be engaged in transplant biology, cardiovascular disease, diabetes and other metabolic diseases.

Broad co-founded the Kaufman and Broad home building firm and once owned SunAmerica insurance company, which he sold to AIG in 1998 for $18 billion, according to Forbes magazine. Broad was estimated to be worth $6 billion by Forbes.

Frankenstein, Train Wreck or Good Listener?

The Los Angeles Times has joined The Sacramento Bee in calling for more public disclosure of the financial interests of scientific advisors to the California stem cell agency.

In an editorial today, the Times said,

"One issue the institute still must confront is making the financial disclosures of its scientific advisors open to the public. These scientists will recommend which grant proposals should be approved, and it's important for the public to know that the reviewers, who often have links to companies and universities, will not be enriched by the advice they give.

"The agency's leaders argue that no worthwhile scientist would stand for such disclosure. But it's entirely reasonable — and increasingly common — to ask stem cell scientists to disclose their financial and research relationships. If a scientist wants to help decide how California spends $3 billion on stem cell research, he or she should be willing to take steps to assure the public that its money is being well spent."

The editorial generally lauded the agency, particularly the ethics and intellectual property rules approved earlier this month. But it added,

"It has taken more pressure from public interest groups than it should have to set the institute on the right path. That's probably because the governing board has no members from such groups, something the Legislature should correct once the three-year moratorium on amending Proposition 71 is over. Still, the board showed that it has learned how to listen and respond, one of its most promising steps so far."

On Sunday, the agency was likened to a Frankstein monster in an op-ed piece in the San Francisco Chronicle. Dana Welch, executive director of the Berkeley Center for Law, Business and the Economy, posed a series of questions about the agency, ranging from the direction of CIRM's priorities to IP rights.

"Prop 71 left these questions and more wide open. Answer any one wrong, or leave them to chance, and we risk a South-Korean-like train wreck, potentially setting back by years the development of potential cures. Answer these questions right, and California becomes a model for other states and countries conducting stem cell research," she wrote.

The questions raised by Welch are identical to the ones being discussed at a conference early in March at Boalt Hall in Berkeley. Her group is one of the sponsors.

Ortiz Seeks Performance Audit of CIRM; Westly Says "Tough Oversight" Needed

Acting on a suggestion of Gov. Schwarzenegger, California State Sen. Deborah Ortiz and nine other legislators are calling for a performance audit of the California stem cell agency.

Their request will come before the Joint Legislative Audit Committee on Wednesday at 1:30 p.m. in room 447 of the state Capitol.

In the letter calling for the audit, Ortiz, a Sacramento Democrat, said the review should include:

"...the strategic policies and plans developed by the CIRM and the ICOC; policies and procedures for issuance of research and facility contracts and grants; policies for hiring and compensation of staff and for procurement of goods and services; policies for managing conflicts of interest for ICOC and working group members; and policies and procedures relating to management of intellectual property rights associated with research funded or commissioned by the CIRM."

She noted that a performance audit of CIRM would have been required by her legislation (SB18) that was vetoed by the governor. She said the governor's veto message urges the legislature to pursue an audit through the Joint Legislative Audit Committee.

Ortiz' request, which includes support from three Republican legislators, calls for completion of the audit by Sept. 30. Her office did not issue a press release on her Feb. 1 request letter. We asked for it after discovering the item on the agenda of the Audit Committee.

CIRM also faces an audit of its own that will cost about $50,000 and be performed by the firm of Gilbert Associates of Sacramento. But the one requested by Ortiz is likely to be the most rigorous.

State Controller Steve Westly, who is seeking the Democratic nomination for governor, announced last week he would be reviewing CIRM's financial activities. Westly's campaign is making a special effort, fueled by Google ads, to "get stem cell research back on track now."

As state controller, Westly is also chair of the Financial Accountability and Oversight Committee of CIRM and is required by law to "review" CIRM's own audit annually and issue a public report.

In a little noticed press release last week, Westly described himself as a strong supporter of Prop. 71 and said, “Tough oversight will ensure the public's confidence in our stem cell program. The stakes are too high for the institute to risk its funds or the public's trust.”

Westly's office will review the audit already commissioned by CIRM and discuss it a meeting of the Financial Accountability Committee later this spring.

In addition to himself, Westly announced that following the following persons are on the committee:

"Richard Siegal, member, appointed by the State Controller
"John Hein, appointed by the Assembly Speaker
"Jim Lott, appointed by the Senate President Pro Tem
"Daniel S. Brunner, appointed by the State Treasurer
"Myrtle Potter, member, appointed by the Chair of the Independent Citizen's Oversight Committee"

No further information was provided in Westly's press release about the qualifications of the five persons.

A copy of Ortiz' letter follows below because it was not available online at the time this writing.

Ortiz's Audit Request Letter

Here is a copy of Sen. Ortiz' audit request letter.

February 1, 2006

Assemblymember Nicole Parra
Chair, Joint Legislative Audit Committee
State Capitol, Room 4005
Sacramento, CA 95814

Dear Assemblymember Parra:

We are writing to request that the State Auditor conduct a performance audit of the California Institute for Regenerative Medicine (CIRM) created by Proposition 71, the California Stem Cell Research and Cures Act, in November, 2004, and to report the results of the audit by September 30, 2006.

We believe a performance audit of the CIRM and the Independent Citizen’s Oversight Committee (ICOC) which governs it would be of great value in guiding the implementation of this large new state program and ensuring that taxpayers’ funds in this area are well spent. Among other things, we would recommend that the audit review the strategic policies and plans developed by the CIRM and the ICOC; policies and procedures for issuance of research and facility contracts and grants; policies for hiring and compensation of staff and for procurement of goods and services; policies for managing conflicts of interest for ICOC and working group members; and policies and procedures relating to management of intellectual property rights associated with research funded or commissioned by the CIRM.

As has been widely reported, the initial implementation of this important new program has been hampered by a number of problems. Due to litigation, the CIRM has not been able to issue bonds to commence making research and facility grants. As a result, the program has relied on loans from private individuals and may soon begin issuing bonds that are not backed by a payment guarantee by the state. In addition, a number of CIRMs hiring, compensation, and contracting actions and expenditures have been questioned as being excessive. Finally, many reviewers have questioned the criteria used to select a site for the CIRMs administrative offices.

SB 18 (Ortiz and Runner) of the 2005-06 Session would have required the State Auditor to conduct a performance audit of the CIRM and the ICOC and to provide the audit report to the Legislature on or before June 30, 2006. It would also have required the State Auditor, on or before October 2007, to provide an analysis of the CIRMs implementation of the recommendations contained in the audit report.

In his veto message, the Governor stated he was vetoing the measure due to concerns that these provisions constituted an impermissible legislative amendment of Proposition 71, which provides that its provisions may be amended by the Legislature in furtherance of its purposes no earlier than the third full calendar year following its adoption by 70 percent of the membership of both houses or the Legislature. The veto message urges the Legislature to pursue a performance audit of the CIRM through the Joint Legislative Audit Committee. Accordingly, through this letter we are requesting that JLAC commission a performance audit of CIRM and the ICOC.

Thank you for your attention to this request. If you have any questions regarding the request, please feel free to contact us or our staffs.

Sincerely,



_
SENATOR DEBORAH ORTIZ, SENATOR GEORGE RUNNER, SENATOR LIZ FIGUEROA, SENATOR SHEILA KUEHL, SENATOR ABEL MALDONADO, SENATOR RICHARD ALARCÓN, SENATOR GLORIA ROMERO, SENATOR ROBERT DUTTON, SENATOR JACK SCOTT, ASSEMBLYMEMBER WILMA CHAN, ASSEMBLYMEMBER JACKIE GOLDBERG

Major Stem Cell Conference Scheduled for March 2-4 at UC Berkeley

Another major stem cell conference is scheduled for March in Bay Area. This one is is being held March 2-4 at UC Berkeley's Boalt Hall and is called "California's Stem Cell Initiative: Confronting the Legal and Policy Challenges."

The 2 ½-day conference has a host of speakers ranging from Ed Penhoet, vice chair of the California stem cell agency, to California state Sen. Deborah Ortiz, who is carrying legislation to step up oversight of the agency. Scientists, academicians, economists and more are scheduled to appear.

You can register at this link. The cost ranges from a $350 corporate level to $25 for students. You can access a fine bibliography of articles by speakers at the conference by clicking here. The other March conference is sponsored by Burrill and Company, a San Francisco life sciences merchant bank. Registration fees are $1495 for that meeting. You can read our earlier item on it here.

Clashing Interests on the Stem Cell Oversight Committee

It happened so quickly that only a keen-eyed parliamentarian might have noticed.

One minute the Oversight Committee of the California stem cell agency had a quorum. The next minute it didn't. It was late in the day last Friday. Some members had already left. Then two more members left the room, after expressing displeasure about procedures to create a long overdue strategic plan on how to spend $3 billion. That stymied a vote on the proposal.

"I am extraordinarily disappointed," said Oversight Committee member Claire Pomeroy, dean of the UC Davis Medical School, "that we are not going to have a quorum. We have not carried through on our responsibilities." Her comments came well after the departure of the two other committee members.

On the surface, the matter seems minor – planning a plan, what could be more picayune? But the real stakes – broadly speaking – pit the priorities of the patient advocates against the academic contingent on the board The patient advocates – 10 out of 29 persons on the committee -- represent groups of persons who have diseases that could benefit from stem cell therapies. Generally, the advocates emphasize great speed in bringing cures to the marketplace. The academicians on the board stress thorough science and warn that it is a slow process.

Serving as backdrop to their issues is the Korean stem cell scandal. Some say the focus on speed was one of the causes leading to the fraud.

On Friday, the plan for the strategic plan was carefully laid out by CIRM President Zach Hall. He said it would be a $500,000 effort, conducted by CIRM staff and brought to the board for approval and changes in the summer of 2006. Hall said Price Waterhouse Coopers would be chosen to assist in devising the plan. Overseeing the effort would be a relatively small subcommittee of Oversight members, selected by Hall.

It was the nature of subcommittee that triggered the objections of the two board members, David Serrano-Sewell and Jeff Sheehy, who walked out of the meeting. Serrano-Sewell said he said he was uncomfortable with the subcommittee and not knowing who would be on it. Sheehy echoed his concern. Their objections were relatively brief compared to the hours-long discussion of the planning process at December's Oversight meeting.

One of the issues complicating the process of coming up with a plan is a state law that requires the public to be notified well in advance of meetings by public bodies.

Hall's plan would avoid much of the time-consuming process by minimizing the number of required public meetings. It would also make it easier to call meetings of the public subcommittee. A smaller group means fewer schedule conflicts when setting up sessions. Hall did indicate that he did not want to short-change the public in terms of its opportunity to make its voices heard.

Representatives from academic institutions praised Hall's plan at Friday's meeting, noting that it was similar to the way their organizations operated. In other words, charging the staff to develop the proposal and bring to it the full board for changes and approval.

But Joan Samuelson, a patient advocate, said the strategic plan was very important and that the board was going to have to "own" it. She later told us that the patient advocates wanted to be very involved in planning and said that others seemed more worried about complying with open meeting laws than the stem cell research.

The discussion of the issue at Friday's meeting was relatively brief. To catch a better flavor of the positions here are a few excerpts from December's Oversight Committee meeting, which unveiled many concerns.

Jonathan Shestack, founder and president of Cure Autism Now:

"The motion that you have before you is a recipe for no board involvement in the strategic planning. Yes, it is. It makes that possibility very real. it makes all input be at will of staff except for presentation at the ICOC meetings. These are large, fairly unwieldy meetings....I don't mean to be negative about the staff because they are expert and fantastic, and we depend on them, but there is right now no real mechanism on the strategic decisions for the various communities to participate, particularly advocacy and particularly industry. And I think that just giving the full duty to staff and saying present it to us once in a while, and we'll tell you what we think is not to get into the detail that some people would want."

David Serrano-Sewell, representing the
Amyotrophic Lateral Sclerosis Association and National Multiple Sclerosis Society

"Commitments from the office of the (CIRM)president...just putting it in one individual -- for me, right now --is not enough. (During) my conversations with my appointing officer (the person who appointed Sewell to the CIRM board), there was a real commitment that we do a good job to represent our constituencies. and for me that's MS and ALS".

Shestack

"I also think there is a danger when all the positions -- academic, advocacy, industry -- are not talking to each other, talking only to a central person who then filters their needs."

Gerald Levey, dean of the UCLA Medical School

"I would hope that the board is not so balkanized that we think about who we represent and how we got here. i think now that we're a board, we're supposed to be thinking like we all have the same goal, the same purpose. and I would hope that the goal is to further stem cell research in the state of California -- not whether academia is being served better in the process or industry or what have you. So i hope that we don't get into a situation where we have us against them on the board."

"The matter of the plan concluded at Friday's meeting with discussion of another plan to hold a conference-call meeting in the next few weeks of the Oversight Committee to vote on Hall's plan for the plan

."

One final note: Nineteen members of the 29-member Oversight Committee are required for a quorum. Otherwise, the board cannot take legal action.

Human Tidbits Amid Stem Cell Policy

The California Stem Cell Report spends most of its time blathering about policy issues involving the California stem cell agency. Good grits for wonks. But there is another view. I just took a quick look at Don Reed's blog, stemcellbattles.com, and his report on last Friday's meeting of the Oversight Committee meeting. He focused on the "spotlight" on diabetes prior to the actual meeting. Nice, human touches and tidbits about the people and players you won't read elsewhere.

Valentine's Day Editorials on CIRM

Two California newspapers came out with editorials today praising actions last week by the California stem cell agency. It is only coincidental that the pieces appeared on Valentine's Day. The critics still want more.

The Sacramento Bee, one of the stronger critics of CIRM, said.

"On Friday, Klein and the oversight committee took a big step toward reversing past mistakes and demonstrating they can operate as an open, responsive public body. After listening to public interest groups, ethicists and legislators, the 29-member committee approved policies on medical standards and commercial licensing of stem cell therapies that, while not perfect, are a vast improvement over where the institute was heading just a few months ago."

But it also wrote,

"For the last several months, the institute has refused to make public the economic disclosure forms filed by out-of-state scientists who will recommend millions of dollars in research grants. The public deserves to know if these advisers have ties to companies and researchers applying for public monies. Since scientists regularly disclose their potential conflicts when publishing or presenting their work, there is no reason they cannot do so while making key decisions on taxpayer-funded grants."

The San Jose Mercury News also praised the egg and royalty sharing policies adopted last week by CIRM.

The Foundation for Taxpayer and Consumer Rights hitched a bit of a ride too on the Valentine Day bandwagon, lauding the actions as moving in the right direction.

But it urged more royalty money for the state, tougher enforcement mechanisms to assure low prices on therapies and creation of a stem cell patent pool to share information on CIRM-funded inventions.

"Certainly companies should make a fair profit on drugs they develop based on Proposition 71-funded research. But they must not be allowed to benefit unreasonably at the public's expense. The Attorney General should have the right to intervene -- 'march-in rights' -- in the event of unreasonable pricing," said John M. Simpson, stem cell project director for the foundation in a letter to CIRM Chairman Robert Klein.

We should also note the piece by Marisa Lagos of the San Francisco Examiner on last Friday's meeting. It pointed out that the CIRM regulations could become a model for the nation.

Reader's Write

The following email came in from John M. Simpson, stem cell project director of the Foundation for Taxpayer and Consumer Rights, regarding our "What's in a Name?" item.

"I liked your astute analysis of the naming rights issue.

"I agree that in a perfect world it wouldn’t happen, but given CIRM’s circumstances the institute probably needs the money.

"The ICOC will have to screen potential donors to make sure there are no outrageous or inappropriate contributions. That’s why the board is there.

"All the transactions must be completely transparent and organizations like the Foundation for Taxpayer and Consumer Rights will continue to monitor ICOC activities to ensure no abuses occur."

We encourage comments, favorable or unfavorable, or even insightful and enlightening. You can post them directly or anonymously by clicking on the word "comment" below each item. Or you can send them to djensen@californiastemcellreport.com.

Egg Irony

LifeNews.com is a Web site adamantly opposed to embryonic stem cell research. It is describes itself as an enterprise that reaches 150,000 pro-life advocates each week through various means.

So it comes as a bit of a shock to see ads on at least one of its Web pages soliciting egg donors. One of the ad sites, Loving Donation, says it pays its egg donors a minimum of $3,000 with high demand donors commanding higher fees. The ads are placed on LifeNews.com pages automatically by Google so LifeNews.com has no direct control over them. It is also unclear whether any of the fertility clinics that advertise also supply excess eggs for research purposes.

The Google ads change regularly on Web pages so there is no guarantee that you will find them there in just the same way. But here is the link to the page where we saw them.

What's in a Name? Ten Million Dollars or More

California is not likely to see something called the Pfizer/CIRM Research Scholars Program, but the stem cell agency is on its way to peddling naming rights in the world's largest stem cell research effort.

Peddling probably is not the most generous way to describe the effort, which seems to be an essential ingredient in assuring funding of programs this year. A more euphemistic way to say it would be: Providing an incentive to make a $10 million gift to CIRM.

The Oversight Committee moved forward with the program last week after stem cell chairman Robert Klein said it would apply only to grants of $10 million or more. Naming rights would not be available to purchasers of bond anticipation notes.

Initial screening of the naming candidates would be done by the executive committee of CIRM in private. The names of candidates would then come before the Oversight Committee in a public session for approval or rejection.

Generally board members last week favored the program, declaring it was a good example of public/private partnerships. Klein said that universities have naming programs for lectureships, fellowships and buildings. Oversight Committee member Jeff Sheehy noted the NIH has a naming program for one of its grant efforts.

During his discussion of the plan, Klein implied that he has a potential donor who is very interested in a naming opportunity.

The naming proposal was discussed publicly as early as August during a Governance Subcommittee meeting (see page 66 of the transcript). It came up again late in the day at an Oversight Committee meeting September. It was then that it encountered its only serious opposition(see page 315 of the transcript).

Gayle Wilson, who is no longer a member of the Oversight Committee, said she did not know of other state agencies with similar programs outside of academic institutions. The wife of former Gov. Pete Wilson said, "I don't think it's a good idea. I think we'll be blasted for it."

Tina Nova, another Oversight Committee member and president of Genoptix, a San Diego biotech and lab firm, said,

"I can see a lot of downside because, as we all know, people are constantly trying to figure out what are the motivations, what are the hidden agendas. At the end of the day, people who are trying to support this initiative in a pure sense ought to be doing it for the benefit of seeing the research advance and not for the benefit of seeing their name associated with fellows who are trained. So I think I'm probably more cautious because I do wonder if at the end of the day we could create more challenges and if it really does help us that much."

Nova did not express opposition to the plan on Friday, but she may have left the meeting by the time it came up late in the session. (It is difficult to keep track of the comings and goings of the 29 committee members, particularly late in the meetings.)

Jesse Reynolds of the Center for Genetics and Society voiced the only public opposition to the plan. He said it could "open the door to real or perceived conflicts of interest." For example, he said it would be inappropriate to grant naming rights to Geron, a California stem cell firm. Klein said he was in "heated agreement" on that position.

Our judgment: In a perfect world, CIRM should not do this. But it needs the money and this is relatively benign, although experience tells us that bigtime donors generally expect a quid pro quo. Sometimes they are innocuous (say front row seats at the exciting Oversight Committee meetings). Other times, CIRM officials may have to vigorously resist inappropriate overtures from the $10 million donors. But that is part of the public responsibilities of CIRM executives and board members. Failure to do so will ultimately surface (there are no secrets in government) and embarrass the agency and the officials personally.

Still Coming Up

We have not forgotten our promise for more exciting items from Friday's meeting, particularly the item about naming rights and the strategic plan flap. We still are planning on those and much, much more. So stay in your seats, folks. However, this time we are not going to promise a specific time frame. But certainly sooner than Bob Klein comes up with his $50 million(see item down one from here.)

CIRM-UK Stem Cell Conference Later This Year

The California stem cell agency plans to co-host a joint conference with the United Kingdom's Medical Research Council and CIRM later this year in Great Britain.

Zach Hall, president of CIRM, announced the plans at Friday's Oversight Committee meeting. He said 16 US scientists and 16 UK scientists would convene to discuss stem cell self-renewal and differentiation.

Hall noted that Council is the equivalent to the National Institutes of Health in the United States and that it is unusual for a state organization and a foreign national council to co-host such a conference. The arrangement carries particular weight because the UK is an international leader in stem cell research.

"California has become sort of a surrogate for the U.S. effort on stem cell research," Hall said. The CIRM president credited Stephen Lynn of the British consulate in California with helping to put together the conference.

Lynn is one of the regular attendees at CIRM meetings and keeps close track of its affairs. We also should add that we know of at least several readers of the California Stem Cell Report with UK connections.

Hall said that his agency still must raise funds to uphold its end of the conference.

Klein Confirms $40 Million Commitment

Stem cell chairman Robert Klein says he is not expecting to be ready to have $50 million to hand over to the stem cell agency at its next scheduled meeting in April, but he says he is close.

During a brief interview following Friday's Oversight Committee meeting, we asked him for more details on his efforts to sell bond anticipation notes to fund the activities of the agency. He said he has more than $40 million in commitments but wants $50 million. Then, Klein said, the state treasurer's office will have to take five to six weeks to complete the paperwork, but he declined to go into more detail.

The notes are expected to be sold to philanthropic organizations. If CIRM loses the lawsuits against it, the notes will not be repaid.

The agency will run out of money in June under its present budget plan.

Ortiz Not Satisfied with Egg Expense Rules

California State Sen. Deborah Ortiz has proposed legislation that could overturn plans by the state's stem cell agency to permit egg donors to be reimbursed for lost wages.

Ortiz, chair of the Senate Health Committee, introduced her bill last Thursday, the day before agency was scheduled to consider proposed rules on egg donations. She sent a letter to stem cell Chairman Robert Klein late Thursday that said,

"The amount and difficulty of administering reimbursement for lost wages, and the possibility that such reimbursement may induce women to undergo invasive procedures, merit more attention and consideration before the ICOC acts on this draft provision."

She said that ethical questions exist about whether reimbursement of wages "constitute inducement or coercion for some women."

Ortiz did not send a representative to the Oversight Committee meeting on Friday, nor were her objections discussed in any detail. We may have missed it, but we don't think they were even mentioned. Given the nature of the bureaucratic process, the committee may not have even been aware of them, although there was more mention of cooperating with the legislature than sometimes is heard at Oversight meetings.

Ortiz' bill, SB1260, is a variation of a measure vetoed last year by the governor. SB1260 would ban the sale of human eggs. It would also establish informed consent standards for donors. The bill goes beyond the stem cell agency to regulate all egg donor operations in the state. Ortiz indicated that her bill, which will come up for a hearing sometime this spring, is likely to be altered to include more protections for egg donors. As it now stands, it does not offer as much protection in terms of informed consent procedures for donors as do CIRM regulations.

The sections on egg payments reads:

"No human oocyte or embryo shall be acquired, sold, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies. For purposes of this section, 'valuable consideration' does not include reasonable payment for the removal, processing, disposal,preservation, quality control, storage, transplantation, or implantation of oocytes or embryos.

"No payment in excess of the amount of reimbursement of expenses shall be made to any research subject to encourage her to produce human oocytes for the purposes of medical research."

The measure does not specifically mention the "lost wages" issue at this point, but it could easily be added. One could argue that the bill, as it already stands, would ban reimbursement of lost wages.

CIRM's policy requires that only "permissible expenses" can be reimbursed under CIRM-funded research. Those are defined as necessary and reasonable costs directly incurred. They may include, but are not limited to, actual lost wages, travel, housing, child, medical care and health insurance.

Ortiz' letter to Klein said,

"The National Research Council and the Institute of Medicine of the National Academies have recommended that women who undergo egg extraction for research purposes should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an Institutional Review Board.... This recommendation of an established, credible authority should be carefully considered before opening the door readily to compensation for lost wages in CIRM-funded research, which may set an undue precedent."

Ortiz additionally said that CIRM's policies "should be tightened to more explicitly require eggs procured outside of CIRM-funded research, but used for this research, to meet the guidelines as adopted."

She said that the section "on fairness and diversity in research (should) include the collection of demographic information, including, but not limited to race, ethnicity, language, age, zip code, income bracket, and state that these records need to be made publicly available. This demographic information is important in the continued assessment of who is involved in the research and who may be affected by it."

Bernard Lo, co-chair of the Standards Working Group that developed the ethics policy over months of hearings, on Friday said that CIRM's policies were a starting point and subject to modification as more discussion and evidence are considered. He went out of his way to express public appreciation for input from all parties, including some who have received a more unfriendly reception from others at CIRM in the past.

At the time of the meeting, it was not clear whether he was aware of Ortiz' concerns in her letter from the previous afternoon.

Some might argue that CIRM's status as a separate entity in the California Constitution allows it to chart its own course on "lost wages." That argument might make a fine point for lawyers, but the practical effect of Ortiz's legislation, should it become law as opposed to CIRM's regulations, would seem to nullify the agency's efforts.

Ethics and IP Coverage Mostly Favorable To CIRM

The California stem cell agency can chalk up a plus on coverage of its Friday decisions on ethics and intellectual property.

Generally, California newspapers described the actions as setting standards that go beyond any in the United States, an assertion that not even the critics dispute. Nonetheless, say the critics, the agency could do more.

The meeting also attracted coverage by at least one Bay Area television station (KGO), NPR and the California public radio organization. But coverage by major newspapers elsewhere in the country was nonexistent. We expect to see some coverage over the standards and IP rules in the next couple of months by news organizations outside of California as the news slowly filters east.

The stories also demonstrated some confusion. One example involved a decision by the Oversight Committee concerning financial accessibility of therapies. The committee approved language to make the therapies available to California public agencies at the price paid by Medicaid, a program aimed at the poor. Some reports said Medicare, the health care program for all persons above 65, instead of Medicaid. Another report said the policies approved would become "law." In fact, they will become regulations that have the force of law. The difference is that laws require action by the legislature or voters; regulations can be enacted and changed by the agencies that issue them.

Reporter Jim Wasserman of The Sacramento Bee, who is a relative newcomer to CIRM coverage, described the impact of adoption of the Medicaid language, which replaced language that said the public agency price should be the lowest commercial US price.

"Those discounts are generally 20 to 40 percent, compared with the 40 percent for the federal government's lowest Medicaid price," Wasserman wrote.

He and other reporters noted that some of the Oversight Committee members representing patient groups were concerned about taking actions that might create economic disincentives. To put their point another way, higher potential profits will spur development of therapies that will help those represented by the patient groups.

Other members of the Oversight Committee noted that the low prices apply only in California, implying that prices paid outside of the state will subsidize care for California poor.

Reporter Terri Somers of the San Diego Union-Tribune carried a tidbit also dealing with economic disincentives. It was mentioned in terms of policies requiring the sharing of information from California-funded stem cell research.

"Joydeep Goswami of Carlsbad(CA)-based Invitrogen said such broad sharing of discoveries is eliminating avenues for commercialization. Invitrogen is a major biotechnology tool company that sells to academic research institutions," she wrote.

Sabin Russell of the San Francisco Chronicle reported some criticism of a requirement that egg donors have an adequate period of time to deliberate about their decisions. He wrote that the comment came from "Shannon Smith-Crowley, a lobbyist for the American College of Obstetricians and Gynecologists, who said that the language is evocative of the 'waiting period' rules that are advocated by opponents of abortion. She said such language in the stem cell arena was 'undermining' years of work to establish that women are capable of making important reproductive decisions on their own."

The Los Angeles Times story by Rong-Gong Lin II focused on the delay in CIRM funding caused by the lawsuits against it. The decisions on ethics and sharing revenue was reported in the last two paragraphs.

The Associated Press, which distributes its product nationally and internationally, carried a non-bylined report that appeared to be a rewrite of the Los Angeles Times, to the point of using the Times phrase "in earnest" in the first paragraph. Rewriting news from "member" papers is common at The AP, and a practice they are legally entitled to under their arrangements with the papers.

Both Steve Johnson of the San Jose Mercury News and Wasserman of The Bee wrote stories Thursday and Friday mornings, laying out the issues, as well as reporting for Saturday's editions. (Johnson's story here, Wasserman's here.)

Reporter David Louie of San Francisco TV station KGO prepared a rare TV report on the agency's action. It was a middle-of-the-road piece that did say the policies reflected "best practices." Without seeing the images and hearing the tone, however, it is impossible to make a complete assessment.

Because of the nature of TV news, CIRM has attracted little coverage from those outlets. But TV remains extremely important in terms of public perception since most people get their news from electronic media – not print.

The morning of the meeting -- before action was taken -- opened with a couple of op-ed pieces as well. One was written by Sherry Lansing, Bernard Lo (co-chairs of agency's standards group) and Zach Hall, president of CIRM. The article in the San Francisco Chronicle described the agency's new policies as "the strongest embryonic stem-cell regulations in the country," going "well beyond current national standards for stem-cell research."

On the other hand, Jesse Reynolds of the Center for Genetics and Society wrote in the San Jose Mercury News that "some essential gaps remain to be filled." One example from Reynolds:

"The proposal leaves the approval of research to local committees that will be formed by, and affiliated with, the institutions doing the research. These committees will consist largely of stem-cell researchers themselves and their scientist colleagues from related fields. With this composition, the committees' sympathies and loyalties will lie with their institutions and with the research.

"What's worse, there is no oversight of these committees. Not only would the fox be guarding the hen house, but no one would be watching the fox."

He concluded:

"Too much is at stake with stem-cell research to rely on what may amount to self-regulation. If women's health is to be protected, and misuses of these powerful new technologies prevented, the local committees must be overseen by a transparent and accountable body independent of the research institutions, the CIRM, and the insider's network of scientists."

Research and IP Policies Clear Oversight Committee

The California stem cell agency today approved far-reaching policies to regulate stem cell research and ensure that the state sees a return on its $6 billion investment.

Only minor changes were made to the draft regulations before they cleared CIRM's Oversight Committee. Robert Klein, chairman of the agency, said they went "above and beyond" national standards. While the proposed rules are likely to establish new bench marks across the country, critics were not entirely mollified.

We will carry more on Friday's events during the weekend. Immediately after the session(which ran from 8:30 a.m. to about 5 p.m.), I was pressed into work as a construction grunt by daughter, Karen, a building industry veteran who is running her own home remodel project (addition of a second story and more). I only began reviewing notes from the CIRM meeting at 10 p.m.

Karen, who prefers to be described as a "harsh taskperson" rather than as an "active taskmaster," has directed me to report to work at 6 a.m. Saturday, so full reports out of the Oversight Committee meeting will have to wait until later Saturday and Sunday.

We will tell you about plans to offer up naming rights to CIRM programs to grant donors who hit the $10 million level. We will tell you about a flap about CIRM's long overdue strategic plan. We will give you an update on the fundraising efforts at CIRM, report on a UK-CIRM stem cell conference, examine news coverage of Friday's meeting and more. Plus the latest from Sen. Deborah Ortiz, who has re-introduced her bill to regulate egg donations, and her criticism of CIRM egg policies.

CIRM has issued a press release on Friday's meeting but it is not on its website as the time of this writing and probably will not be posted website until Monday, so the full text is below.

Text of CIRM News Release on Approval of IP and Research Policies

Here is the text of the press release by CIRM on Friday's meeting. It was not available on the Web at the time of this posting.


ICOC RATIFIES KEY POLICIES FOR CIRM-FUNDED RESEARCH
Members Unanimously Approve CIRM Regulations and Intellectual Property Policy

STANFORD, Calif.—The Independent Citizens’ Oversight Committee (ICOC) today ratified two key policies for research funded by the California Institute for Regenerative Medicine (CIRM): the CIRM Regulations for ethical, medical and scientific accountability and the Intellectual Property (IP) Policy for Non-Profit Organizations. These policies were recommended by the Standards Working Group and IP Task Force after months of deliberations.

Developed with input from the California public and state legislature, the policies include provisions that enhance and surpass federal and state guidelines for scientific standards and intellectual property.

“These policies are representative of the ICOC’s commitment to ensuring that CIRM-funded research is conducted under the highest levels of public oversight and transparency,” ICOC Chairman Robert Klein said. “The working group and task force members went above and beyond the gold standards recommended by the National Academies to enhance those standards and policies, reflecting the leadership of California in protecting patients and advancing scientific research.”

“The CIRM Regulations and IP Policy provide CIRM with a strong foundation to carry out its mission of funding stem cell research in California,” CIRM President Zach Hall, PhD, said. “With the approval of these policies, CIRM has the most stringent ethical, medical and scientific standards in the country.”

CIRM is now the first agency in the United States to require specialized review by a Stem Cell Research Oversight (SCRO) committee and to provide for medical costs resulting from any immediate complications of egg retrieval. It also enhances state and federal policies in the areas of voluntary-informed consent and guarantees that all cell lines used by CIRM-funded researchers are derived without compensation to egg donors. The regulations were developed under the guidance of the Standards Working Group, which is comprised of nine nationally recognized scientists, four ethicists and five ICOC patient advocates. To view the full text of the regulations online, please visit: http://www.cirm.ca.gov/meetings/pdf/2006/02/021006_item_9.pdf.

The IP Policy for Non-Profit Organizations also sets a high bar for CIRM, surpassing the federal statute on the sharing of data and biomedical materials and allowing California research institutions to freely use all CIRM-funded patented inventions. Written by the 11-member IP Task Force, this subcommittee held four public meetings and twice reported to the ICOC with their findings. The full text of the IP Policy is available at: http://www.cirm.ca.gov/meetings/pdf/2006/02/021006_item_8.pdf.

In developing the CIRM Regulations and IP Policy for Non-Profit Organizations, multiple public hearings and meetings were held throughout California to gather input and incorporate public feedback into the final recommendations. Members of the California State Legislature personally contributed recommendations that included in the final policies.

With the ICOC’s approval, these policies will now enter into the formal rule-making process governed by the Administrative Procedures Act and have the force of California law.

Cryptic Agenda Not Good Enough

On Wednesday, we discussed the failure of CIRM to meet its commitment to the highest and best standards of transparency and openness. This item will offer more specifics on matters on which CIRM apparently does not want the public to be fully informed.

CIRM will deny that it is trying to keep important issues under wraps, citing staff shortages and other difficulties. But the fact is that if the agency had the will, it could make the information available. It has hired a nationally known PR agency, but none of those considerable resources seem to have been applied in the most fundamental of all PR efforts. And that is to provide the basic information about what CIRM is doing and why.

We have acknowledged CIRM has done a better job concerning the IP and research standards policies, although given their far-reaching implications, it would have been better to have seen the latest drafts posted a week earlier. They are the heart of the Oversight Committee's agenda on Friday.

Those two draft policy postings on the Web, however, are exceptions to the general obliviousness of CIRM to the need to inform the public well in advance about the issues it is considering. That means explanation and context online, not just cryptic one-line agenda items.

For the record, here are the cryptic agenda items. They are from the CIRM website less than 12 hours before the meeting at which they are going to be considered. If you would like to comment before the Oversight Committee, good luck.

Failure in Public Responsibility: Feb. 9th's Roll Call
(Items – quoted verbatim – from the Oversight Committee agenda on Friday that offer no explanation, justification or details.)

"Consideration of naming opportunity for CIRM training grant program." (Our comment: This may involve the sale of the naming rights to the program, as the naming of sports arenas are sold to such companies as Staples.)

"Informational report on plan/process for development of Scientific Strategic Plan."(Our comment: This involves important issues concerning priorities of the patient advocates vs. the pure research folks on the Oversight Committee.)

"Consideration of scientific meeting: Assessing the Medical Risks of Human Oocyte Donation" (Our comment: This is likely to involve significant expenditures, not to mention the important nature of the topic.)

"Consideration of joint venture with Public Library of Science and New York City Stem Cell Research Foundation."(Our comment: This may be some sort of open access arrangement, which could have national implications.)

"Chairman’s Report" and "President’s Report" (Our comment: These usually contain significant information, including Power Point presentations prepared in advance. But on at least one occasion the president of CIRM was surprised by a significant proposal in the chairman's report.)

Does CIRM Have a "Secret" Proposal on Openness?

We are sad to report, once again, the failure of the California stem cell agency to comply with its own promise of the highest standards of openness and transparency.

We have written repeatedly about the failure of CIRM to provide adequate background material in a timely fashion on the important matters on its agenda. Even some of its own directors have complained publicly.

The most recent example is Friday's meeting of the Oversight Committee. For example if you care about open access to CIRM-funded findings, you would be hard pressed to determine whether that is a subject to be considered at the session -- aside from the IP draft rules.

But apparently it is. There is a brief mention on the agenda of a proposed venture with the Public Library of Science. If you dig into that enterprise, it is all about making scientific findings widely available. Why isn't there additional information available from CIRM about the venture? There is a bit of irony in all this – an apparent openness proposal that is basically being advanced in secret.

Is CIRM going to sell naming rights to its stem cell scholar program? In other words, are we going to have something known as the World Savings Stem Cell Scholar Program. The quid pro quo may be purchase of CIRM bond anticipation notes. Maybe that is on the agenda(item 13) as well. It is impossible to tell from the document online. But we heard stem cell chairman Robert Klein broach the idea in September at a meeting of the Oversight Committee.

More details may be posted on these matters as the day progresses on Thursday. But most interested parties, if they wish to make their views known, cannot simply abandon all other plans on a one-day or less notice to appear at Friday's Oversight Committee meeting.

That said, we should give credit to CIRM for posting the IP policy and research standards earlier this week. In the case of IP, it was on Saturday. An excellent example to be emulated for all agenda items.

Disclosure From the California Stem Cell Report

As many of you have noticed, the information about how this blog is produced states that it is written from a sailboat on the west coast of Mexico. For the record, we do make occasional trips back to the Old Country. Most recently, we have been in California since the beginning of December for a variety of reasons, including the birth of a grandson in Santa Barbara on the Winter Solstice (also the date of the biggest surf of year) and the remodel of our daughter's home in San Mateo. She is an active taskmaster. We have worked as a day laborer, electrician, child care provider, cook, personal shopper, project consultant and handholder under her direction. The same can be said for our son, the surfer, who was tending to birthing matters instead of breaking waves on the day of his child's arrival. We have had the opportunity to demonstrate plumbing, carpentry, gardening and solar power skills at his home, in addition to dealing with the usual conundrums of newborns and parents with their first child. These are not novel experiences, we might add, as any grandparent can attest. We salute them all.

What that means for this blog is that we have attended some CIRM meetings, toured the headquarters and discussed matters with both the agency staff and the regular observers, critics and supporters of CIRM. A visit late last summer also permitted such indulgences. On the other hand, that does mean we snatched precious time away from grandchildren, not to mention their parents, who are nearing the dreaded age of 40.

But on the issue of disclosure, we want to let our readers know that we have no investments in biotech firms or any other organizations that could benefit from stem cell research, except through mutual funds, which, of course, we have no control over. We do not hold any mutual funds that are industry specific to biotech.

Beyond that, we are not employed nor do we receive funds from any organization involved in biotech or stem cell activities. Nor is any member of our immediate family (meaning wife and children) involved in such a fashion. As far as we know, no distant relations are involved in biotech or have investments in that area.

We also have no financial connections with organizations critical or opposed to CIRM.

One would hope that reporters, observers or anybody trying to influence CIRM (which is not the same as reporters) would be willing to make the same sort of economic disclosure as above. By that we mean specific dollar amounts, from $1 (one dollar) and up – not those wimpy disclosures required under state law or by CIRM.

Beyond the economics, the California Stem Cell Report supports embryonic stem cell research. And we believe that CIRM is pursuing a worthwhile endeavor, albeit in a somewhat imperfect manner. We also believe that openness, transparency and disclosure are fundamental to good government. That means providing background agenda material well ahead of meeting dates, among other things. Otherwise, meetings can amount to nothing more than sneak-through business, plenty of which can be seen in Congress and the California Legislature.

We also believe in maximum disclosure; when it doubt lay it out. Specifically all significant persons within CIRM, including members of CIRM working groups, should publicly disclose their economic interests in more detail than required by state law.

If you have any further questions about our basic assumptions or potential conflicts, please send an email to djensen@californiastemcellreport.com or use the "comment" function at the end of this item.

Are Women Ready to Donate Their Eggs for 'Nothing?'

Ready to dig into the question of whether women should be allowed to sell their eggs or, put another way, how much should they be allowed to receive?

The latest version of proposed CIRM rules dealing with such questions is now available online for your reading pleasure. Basically CIRM is ready to answer that if women want to sell their eggs, none of its researchers are buying. And it wants to put limits on what the women can receive – no more than expenses, including lost wages. Of course, women who want to sell their eggs can go elsewhere, where CIRM standards are not applicable.

But what CIRM decides at the meeting of its Oversight Committee on Friday is likely to establish a national model for stem cell research standards. As CIRM points out in a press release, the rules would make CIRM the first agency in the country to:

"legally mandate specialized review by a Stem Cell Research Oversight (SCRO) committee;
"enhance state and federal policies in the areas of voluntary-informed consent;
"protect health of women donating eggs for research;
"guarantee that all cell lines used by CIRM-funded researchers are
derived without compensation to egg donors."

It is impossible to cover all eventualities when drafting such ethical standards. It is also impossible to stop all persons determined to violate ethical codes or the law, but some questions appear to remain in the draft.

One involves the use of eggs from distant sources. It is relatively easy to check out procedures used by egg providers in the United States. This country has a relatively uniform ethical approach in science, although there are always a few rogues. But distant locations such as Thailand, which already is notorious for its sex industry, are harder to assess. To what lengths are California researchers going to go to ascertain whether an egg supplier in Thailand has similar informed consent procedures to those here? How will payments to foreign donors be evaluated? "Necessary and reasonable costs directly incurred" could mean something far different in another culture than in California.

The proposed rules put much of the burden of answering these questions on the recipients of the grants, both the individual and institutions. How well the standards will be applied will depend, in many ways, on the rigor of the recipients. CIRM proposes penalties for failure to comply. Of course, if problems arise, the ethical standards can be strengthened.

The proposed rules additionally require that unspecified "steps shall be taken to enhance the informed consent process. " They require the researcher to ascertain that the donor understands the "essential aspects of the research." Couple that with reimbursement of donor expenses, it could lead to the hiring of expensive consultants for donors or creation of costly donor education conferences, both of which could be deemed a reimbursable expense. Such activities may well be appropriate but they do open the door to potential abuse. Again the recipients and their institutions will play a critical role in regulating activities. They are likely to want to play it safe in terms of ensuring informed consent, both to comply with CIRM rules and ward off potential lawsuits. That comes at a price. Not to mention the possibility of kickbacks by unprincipled consultants to donors who hire them.

Again, these are difficult issues to address, and any set of rules can be circumvented or abused. Oversight of the ethics standards should be a top priority for the CIRM.

While we are on the subject of standards, reporter Dan Levine of the San Francisco Business Times put together a good overview of many of the issues involved.

Levine quotes David Magnus, director of the Stanford Center for Biomedical Ethics, as saying, "If Massachusetts decides they are going to allow payment of egg donors, and California decides they aren't, then we won't be able to share cell lines derived from one state to another. Whatever policies wind up getting put in place for this kind of an issue, it's really important that everybody be on the same page and have the same policies."

Levine also quotes Ronald Green, director of the Ethics Institute at Dartmouth College and chair of the ethics advisory board of Advanced Cell Technology, as saying, Our experience is that they (women) are not willing to step forward and donate eggs for nothing. It is not enjoyable to be injected with powerful drugs that alter your mood and hurt you, and the whole process and potential for organ failure, all culminating in a transvaginal needle harvest through the back wall of the vagina. How many women are going to do that to assist research to understand diabetes?"

Free Parking for Friday CIRM Meeting

Free parking is available for Friday's meeting of the Oversight Committee at Stanford University. The parking area is located in Galvez Field Parking & Frances C. Arrillaga Alumni Center, according to CIRM. For directions, see: http://forum.stanford.edu/visit/directions/arrillaga.

Bad Link on IP Policy

A reader reports there was a bad link to the IP draft to be considered at Friday's meeting. Thanks to the reader for pointing it out. It has been fixed. Here it is for those who need it right now: http://www.cirm.ca.gov/meetings/pdf/2006/02/021006_item_8.pdf

CIRM and the $40 Million Matter

God and the Main Stream Media – they both move in mysterious ways.

The case in point is whether the California stem cell agency is broke. Lawsuits have prevented it from issuing the bonds that were designed to fund it. So the agency has been living on the dole with loans and handouts, although that is a less than a positive way to describe the $5 million the Dolby Foundation gave to CIRM.

Last month reporter Marisa Lagos of the San Francisco Examiner reported that the agency had raised $40 million, basically solving its financial crisis. That is a big story. On a slow day, it might even be front page news for many California newspapers -- properly told.

Lagos' Jan. 17 report was based on a speech by stem cell chairman Robert Klein that none of the Main Stream Media covered. In covering that speech, she was following some of the basic rules for good reporting – be on the scene, cover the principal, don't assume. She deserves considerable credit for even knowing about the speech. It was not publicized by CIRM and did not surface in advance with any of the usual Web search engines. So why has her report been widely ignored?

For those of you who do not keep up with the twists of the newspaper business, the Examiner is a shell of its former self. It has found itself in a situation where it cannot charge for circulation and is distributed free, including home delivery, in some San Francisco area communities.

That means that other newspapers with paid circulation do not pay much attention to it. They sniff at a story in a free newspaper, weekly or daily as is the Examiner. So the Main Steam Media do not try to match stories in these ragtag rags even when they enjoy greater economic success than the conventional dailies, which many of them do.

The California Stem Cell Report (this thing that you are reading) did confirm that CIRM has raised $40 million. But what may be more interesting is that the figure has now been reported in the Main Stream Media. Say what you will, having information published in a newspaper is still more important than having it published on the Web. It probably has to do with the smell of the ink, but if you want to know more, send me an email and I will explain.

Reporter Terri Somers of the San Diego Union-Tribune, which is very definitely Main Stream Media, reported the $40 million figure once more in a story during the weekend. She said that Klein, at an appearance Friday at the Stem Cell Research Center at the Burnham Institute for Medical Research in La Jolla, basically confirmed the amount. Somers deserves kudos for pursuing the $40 million matter, which all of the other major newspapers in California have ignored.

The mysteries of the Main Stream Media are deep and complex. In discussing coverage of the $40 million matter, we have touched on only a sidelight of the media's arcane and byzantine world. Next week we tackle God.

Latest Version of Stem Cell IP Policy Ready

The Intellectual Property Task Force of the California stem cell agency has met its self-imposed deadline for posting a proposed draft of its rules for sharing the swag.

Last month, Ed Penhoet, chair of the task force, swore that the draft, to be considered by the Oversight Committee this Friday, would be available online by Feb. 5. It was posted at least by Feb. 4. You can read it here.

However, the rest of the agenda for the Oversight Committee consists of little more than brief notations with no backup material, as is usually the case, with only three business days left before the meeting. The Oversight Committee will be very busy at its Stanford session. Not only is intellectual property up for discussion but also proposed rules for ethics and research. Either IP or ethics could easily take up a full day, if the committee had time.

We expect to see more background material on CIRM website, perhaps on Wednesday or Thursday. We will carry items on the material, as warranted.

If you are planning on attending the Stanford meeting, you may want to visit the Stanford web site to figure out parking arrangements, which can be difficult and expensive. We are also told the campus police vigilantly ticket offenders.

'Unbalanced?' but 'Very Good'

It is something of an odd company.

Aphidwatch.com. DNA binding, the National Academies Web site on evolution...and the California Stem Cell Report. What do they all have in common? A write-up in a review of websites in the Genetic Engineering News, which says it is most widely read bionews publication in the world with a "market reach" of 199,143.

The Web site review, which the magazine calls one of it most popular features, is written by Kevin Ahern, who teaches in the biochemistry and biophysics department at Oregon State University.

His bottom line on the California Stem Cell Report:

"The best way to keep informed on this topic may be to watch this site."

His summary:

"Strong Points: Topical ; Weak Points: Unbalanced? ; Rating: Very Good "

We should note that Ahern's snippet on the California Stem Cell Report was only one item removed from another on foot-and-mouth disease.

Disclosure of Researchers' Financial Interests to Subjects Recommended

A couple of UCLA law professors have published a research paper exploring stem cell research and the law, ranging from informed consent to the law of human tissue to patents.

Russell Korobkin and Stephen Munzer prepared the 112-page research paper published by the UCLA School of Law. Dated this month, it is a thorough and timely overview of the issues.

A couple of items caught our attention. One of their recommendations calls for full disclosure of the financial interests of researchers to their human subjects.

"Requiring such disclosure would not, despite what the court asserts, 'chill medical research.' Further, the autonomy principle suggests that disclosure of financial interests is even greater in non-therapeutic contexts where subjects lack the incentive to participate in research in order to obtain direct health benefits. The law should require the full disclosure of scientists’financial interests, if any, in the results of their research."

They also support some sort of compensation for donors, a position the California stem cell agency opposes. They wrote that it "should be possible for donors to receive non-cash compensation and for 'disease groups' to negotiate for royalties or treatment."

They continued:

"The greatest concerns with undermining human dignity arise in the context of the sale of embryos, for they have the potential to develop into human beings. Even in this context, however, we are wary of prohibitions. There is reason to believe that human dignity is better protected if the availability of compensation for unused embryos enables people , who otherwise could not afford IVF, to use that process to create a baby."

Light Coverage of Stem Cell Research Standards

Only two California newspapers seem to have covered this week's important developments on the ethics of state-funded stem cell research and initial approval of standards that are certain to set a new bar nationally.

We have already noted The Bee's coverage. Reporter Sandi Dolbee of the San Diego Union-Tribune also produced a piece this morning with some interesting details. Dolbee's article made it clear that reimbursement of egg donors for lost wages was okay. And she noted a dissent from a member of the public.

"'I think this compliance section is pathetically thin,' said Susan Berke Fogel, founder of the Pro-Choice Alliance for Responsible Research, who wanted more specifics about enforcing the rules."

The Bee reported some disagreement among members of the CIRM working group concerning the compensation issue.

"Several working group members contended women should profit because egg extraction is onerous and potentially risky.
"Ann Kiessling, a Harvard University biologist who runs an independent nonprofit lab harvesting eggs for stem cell research, said donors spend up to 200 hours on travel, legal reviews and medical procedures to provide eggs for research.
"'That women shouldn't be compensated is the most unethical position,' said panel member Jonathan Shestack."

Other newspapers may have carried reports on the standards, but they did not appear in the usual Web searches. We checked the Los Angeles Times site specifically since the standards meeting was in Los Angeles. We also checked the San Francisco Chronicle site specifically since CIRM is a hometown agency. Neither appears to have covered the matter.

Can the Research Standards be Policed?

A lengthier version of The Sacramento Bee story on the stem cell research standards is now available on The Bee's website. Among other things, it says,

"Jesse Reynolds, Center for Genetics and Society program director, complained that potential grantees got a private meeting with the agency's staff to give their input on the guidelines in December. He also said the state's stem cell institute doesn't have enough staff to effectively police researchers' compliance with the standards."

The article also said,

"'What we did is so far ahead of the rest of the United States that I think these will become the national standards,' said Bernard Lo, the working group's co-chair. 'We really want to be in the lead here in terms of ethical standards, as well as the research.'"

Lo said he believed CIRM would have sufficient staff to police the standards.