CIRM Posts Draft of Strategic Plan

The California stem cell agency's 194-page draft of its strategic plan has been posted on CIRM's web site, several hours after news stories with details of the report appeared. However, there is nothing on the CIRM's main web page at the time of this writing to indicate that this fundamentally important document is available to the public.

Interestingly, the cover has a quote from Roman Reed, son of patient advocate Don Reed, who expressed some reservations about the plan.

Roman is paralyzed with a spinal cord injury. It was he who came up with the motto of the agency: Turning stem cells into cures. That motto is on the cover of the plan.

A Quick Look At Who is Covering CIRM's Plan Today

As of the time of this posting, neither the San Francisco Chronicle (the hometown paper for the California stem cell agency), the Los Angeles Times (the state's largest paper), The Sacramento Bee nor the Orange County Register appear to have posted stories online concerning CIRM's strategic plan. The San Jose Mercury News and the San Diego Union Tribune both have stories online. The San Diego paper performed a nice public service, posting the executive summary online. As of this writing, the plan was not available on CIRM's web site. For links see items below.

Some Unhappy with CIRM's Strategic Plan

Reporter Steve Johnson of the San Jose Mercury News also moved quickly on the CIRM strategic plan, reporting in the lead of his story that the proposal dismayed some advocates of the sick and disabled.

Here are some excerpts:

"Zach Hall, the institute's president, said he and others who developed the plan were extremely careful about wording it so it set obtainable goals that didn't unrealistically raise the public's hopes.

"'One of the points really is to try to educate people about what a long process it is to get any `therapeutic' approved,' said Hall, who predicted it might take 15 years before the institute's research results in a medical product."

Johnson continued:

"But others found the plan's cautious approach disheartening.

"'I consider this report's estimate to err on the side of over-caution,' said Don Reed of Fremont, whose son was left a quadriplegic after he broke his neck in a college football game. "While it is right and proper for scientists to be careful,' said Reed, who attends many of the institute's meetings, "I take a more optimistic view. In 10 years, I expect my paralyzed son, Roman Reed, to be walking.'

"That sentiment was echoed by 60-year-old Bill Franklin of Los Altos, who has suffered from Parkinson's disease for 11 years.

"'There's no reason for things to take that long,' said Franklin, who worked to help pass Proposition 71, which created the stem-cell institute. 'People with PD and other diseases, they want things to happen faster.'"

Johnson also had comments from two CIRM Oversight Committee members:

"Jeff Sheehy, a member of the institute's board who suffers from AIDS and participated in the group that developed the plan, said no matter what progress companies make, it's vital for the institute to proceed cautiously and methodically.

"'There still is a lot of work that will need to be done to make these therapies widely available and safe,' he said. 'This is a daunting scientific challenge.'

"Joan Samuelson, a board member with Parkinson's disease, agreed that the institute needs to be thorough. 'But we also are in a rush,'' she added. 'That means every day we report to duty as if somebody is dying.'"

More Details on CIRM's Strategic Plan

Reporter Terri Somers of the San Diego Union Tribune moved quickly and was probably first on the Web with substantial details of the strategic plan drafted by CIRM staffers. It has been reviewed along the way by the Oversight Committee but final approval is not slated until December.

Here are excerpts from her story. The executive summary can be found on the newspaper's web site (see item below) and not on the CIRM web site at the time of this writing.

"The institute has already announced that it will be seeking applications for grants intended to “jump-start” human embryonic stem cell research in California. Under the plan, $135.3 million would be spent on the jump start initiative.
"An additional $148.5 million would be earmarked for annual innovation grants, and $75.3 million would fund work in the basic biology of stem cells.
"The plan also directs money toward science that is directed at a specific mission, such as the investigation of better methods of generating specific types of stem cell lines, such as those that can be used as models of diseases, or using stem cell to create copies of tissues and organs that can be used in the lab to test new therapies for various diseases.
"More than $60 million would be directed to scientists who are researching ways to create stem cells that would not create a toxic response from a patient's immune system if used in a therapy.
"About $451 million would be given to researchers in academia and biotech companies for early-stage clinical testing of promising therapies. and $108 million would be directed to academia and industry for core services such as accredited manufacturing facilities.
"The plan also calls for innovative funding techniques.
"For instance, about $122 million will be directed toward disease teams.
"These teams would include scientists who will work together over a number of years to develop a therapy. The work would have to follow a careful, detailed and plausible strategy with defined milestones for bringing the therapy to clinic.
"The plans calls for $60 million to be spent on interdisciplinary research teams working on a specific scientific goal.
"Recognizing that stem cell research will influence society in ways other than new therapies, the committee will sponsor empirical research and conference that take a more theoretical approach to dealing with moral issues. For that purpose, $25.5 million has been budgeted.
"The institute will also spend $2.3 million for outside experts to assess the economic impact of stem cell research in California, and $10 million for public outreach programs that include a web portal and educational workshops."

Executive Summary of CIRM Strategic Plan Draft

Here is a link to the executive summary of the draft strategic plan of the California stem cell agency. It is on the San Diego Union Tribune's web site and was not available on the CIRM web site at the time of this posting. See this location for the summary.

CIRM's Draft Plan Calls for $463 Million to Push Stem Cells into Clinics

The California stem cell agency today released the long awaited draft of its strategic plan and called for spending $463 million for research aimed at bridging the gap from basic stem cell discoveries to treatment in the clinic.

That was the single largest amount specifically delineated by the plan, according to the Foundation for Taxpayer and Consumers Rights, which posted a press release on the plan even before the plan was available on CIRM's own web site.

The foundation said $451 million was recommended for clinical trials, with costs shared with industry.

John M. Simpson, stem cell project director for the foundation, said:

"During the Proposition 71 campaign, proponents implied that miraculous cures were just around the corner. This plan acknowledges just how difficult the task ahead is and is a welcome change from the hype that has all too often been associated with stem cell research. Californians are entitled to an honest assessment of the prospects for research they are funding."

The draft will be discussed at the Oversight Committee meetings in Los Angeles later this month. Final approval is scheduled for December.

We will have more on this later today when the plan becomes publicly available.

(Editor's note: An earlier version of this said $423 million was recommended for bridging the gap between the lab and clinic.)

Feds Say 'Substantial Question' Exists on WARF Patents

The federal government will review Wisconsin's claims to patents on embryonic stem cells in a move that will probably take a few years to play out.

The agency agreed that "substantial questions" exist involving the patents.

Reporter Andrew Pollack of the New York Times wrote:

"Re-examinations brought about by a third party, as this one was, result in all the patent claims being canceled 12 percent of the time, said Brigid Quinn, a spokeswoman for the patent office. In another 59 percent of cases, smaller changes are made. Ms. Quinn said the patent office receives 400 to 500 requests for re-examinations each year and grants 90 percent of them.

"The Wisconsin Alumni Research Foundation, or WARF, a patent licensing organization affiliated with the university, provides academic researchers with free licenses and charges them $500 for cells. Companies are charged $75,000 to $400,000, depending on their size and the terms of the license. One company, the Geron Corporation, has exclusive commercial rights to heart, nerve and pancreatic cells derived from the embryonic stem cells."

Reporter Kathleen Gallagher of the Milwaukee Journal Sentinel quoted John M. Simpson of the Foundation of Taxpayer and Consumers Rights of Santa Monica, Ca., one of the two nonprofit groups challenging the patents, as saying his organization was not motivated by regional jealousy. Gallagher wrote:

"'If California had these patents with these claims, we'd be trying to challenge them,' said Simpson, who was born in Madison and whose mother worked in a research lab on the UW-Madison campus."

Here are links to other news stories and press releases: The AP(which appeared overseas), Terri Somers of the San Diego Union Tribune, Jim Downing of The Sacramento Bee, Bernadette Tansey of the San Francisco Chronicle, David Wahlberg of the Wisconsin State Journal, Rob Waters of Bloomberg, Foundation for Taxpayer and Consumer Rights press release.

Rules Approved for Millions in Lab Grants

After hearing statements that new lab space is running from $500 to $800 a square foot, a panel of the California stem cell agency Monday approved procedures to move quickly on laboratory grants to be awarded early next year.

The Facilities Working Group, in only its second meeting ever, approved criteria and bylaws that will go before the Oversight Committee for approval Oct. 11.

That will set the stage for a round of millions in grants for small-scale renovations of labs so that they can perform embryonic stem cell research.

Only a few changes were made in the selection process and criteria posted earlier on CIRM's web site. Added to the criteria were consideration of how soon a project can be operational and the record of the grant applicant in terms of staying on budget and completing projects on time. The exact language will be worked out and posted on the CIRM web site, probably on Wednesday.

The panel amended the bylaws to ensure that alternate members of the facilities group could vote on grants. The working group also indicated it would insert language to bar group members from discussing specific grant applications with the applicants once the proposals were submitted.

The group discussed a provision in the bylaws concerning the requirement of matching funds from applicants, giving preference to applicants with higher matching amounts. The issue involved whether applicants could get credit for money spent on the project prior to the grant. Just how that is all worked out will probably have to wait for the Oversight Committee meeting.

The agency is considering making as many as 15 grants, possibly up to $2 million per year. The current plan is to seek applications later this month with approval in March or April.

The agency can make about $300 million in facilities grants. Criteria for larger projects will be developed next year.

Read All About It! At Least Some Of It

The agenda for the Oct. 10 and 11 meetings of the Oversight Committee for the California stem cell agency is now available on CIRM's web site with the draft of the strategic plan expected on Wednesday.

As usual, the sessions are fully packed. Much of the background material is not yet available, but the agency seems to be doing a better job of posting the material earlier.

We make that comment after being obliquely chastized on Monday by one CIRM staffer for failing to note when the agency improves its performance. Point taken.

Scheduled to be posted on the CIRM web site on Wednesday is a rather hefty document – the draft of the strategic plan for the agency. We are told it is in the range of 90 to 100 pages, so plan on curling up in the front of the fire for a good read.

If you want to influence CIRM's spending plans, now is the time to weigh in. The plan comes up for discussion at the meetings next week. It is scheduled to be approved at the Oversight Committee in December.

Whittling Down the Researchers: The 'Unhappy' Result of Stem Cell Enthusiasm

The California stem cell agency faces a nearly overwhelming task in the wake of notices from about 350 scientists, saying they intend to apply for about $100 million in grants over the next few months.

The agency has already moved to whittle down the number of potential applicants by requiring the institutions involved to certify that the letters of intent were filed by principal investigators. One veteran stem cell scientist, who is not affected by the certification call, said the requirement has left "fair numbers of angry and anxious people."

The certification will elminate some, perhaps many applications from less senior scientists, despite CIRM's intention to encourage younger researchers.

The requirement for a letter of certification was not mentioned in the initial instructions for the letters of intent. The certification form that was posted on CIRM's web site was created on Sept. 19, four days after the deadline for the letters of intent.

In response to a series of questions from the California Stem Cell Report, Dale Carlson, chief communications officer for CIRM, said,

"The certification form was promulgated after the LOIs(letters of intent) came in, to clarify the qualifications necessary to apply for either grant (PI must be an independent investigator, full-time, on-site, etc.). It may eliminate some full applications from some who filed LOIs but aren't qualified for grants. It's common to require written confirmation of portions of a grant application. I haven't heard of any complaints."

However, it is clear that some folks are disappointed and feel as if the rules were changed in the middle of the game.

The scientist who discussed this issue with the California Stem Cell Report asked not to be named for a number of reasons. We understand that position. For us, it is enough to say that CIRM plays a vast role in the funding of research, and no prospective applicants are likely to want to appear to be grousing about its conduct. Anonymity of sources, however, always raises a flag. In this case, the individual we spoke with is well respected in the field and has had considerable experience with grant reviews, conducting them for the NIH.

Here is what we learned during our discussions, which dealt primarily with the SEED grants, which attracted 280 scientists. CIRM says the grants, which are scheduled to be voted on by the Oversight Committee in February, are aimed at bringing in "new ideas and new investigators."

Many of the scientists who filed letters of intent will be disappointed, we were told. Many aren't qualified under the terms of the certification. A good part of the problem is the classification of reseach scientists at many institutions as non-faculty. Instead they carry titles such as research professional or staff scientist. The letter of certification asks institutions to certify that an applicant holds a "faculty-level position," among other things.

The fundamental problem is the size of the potential applicant pool. The scientist compared it to an NIH experience in which the number of applications was far smaller but the number of reviewers much, much larger. Even if the number of CIRM grant applications is reduced by half, it is still too large for the 15 scientific grant reviewers.

We asked CIRM about the workload, assuming ultimately 200 applications with about two hours spent on each grant by each of CIRM's scientific reviewers. By law, as we understand it, each reviewer in the CIRM grants program must examine each application. That amounts to 400 hours or 10 "normal" work weeks for each scientist, who already has a full plate with his or her own work. Is that a reasonable estimate, we asked CIRM last Monday. If not what is? We have not yet had a response on that matter and others, such as whether it is fair to impose what appears to be a requirement that was not laid out in the original request for letters. We have indications that a response may be coming at some point. We will carry it when it arrives.

The scientist we talked to did not have a solution to the workload issue or how to fairly screen out some of those who filed letters of intent. But it is clear that fixing the number of reviewers in state law is a limiting factor, to put it mildly. It would be useful to be able to revise such minutia without going to a vote of the people, which is what is currently required for a change.

CIRM reviewers are all from out-of-state and cannot apply for CIRM grants. Although reviewers can learn from the reviewing process, our scientist said that it is a "great burden" to be a grant reviewer, either for CIRM or the NIH. Most do it out of an "irrational sense of altruism."

Let us know about what you think about this issue. Click on the word "comments" below to express your opinion. It can be done anonymously. Google, which hosts this blog, has set up anonymous comments in such a fashion that not even we can determine the names of those who use the "anonymous" feature.

Here is a link to the certification form and the application instructions.

Wisconsin Rachets Up Its Stem Cell Pitch

Like Arnold Schwarzenegger, Wisconsin Gov. Jim Doyle is in a re-election campaign. And like Arnold, Jim is courting the stem cell vote.

Last week Doyle announced that Wisconsin is not going to take the Golden State's $3 billion stem cell research program lying down.

He announced that Wisconsin Alumni Research Foundation (WARF) "will offer free, non-exclusive licenses to conduct embryonic stem cell research to companies that are sponsoring such research at Wisconsin non-profit and academic institutions," according to a story by reporter Kathleen Gallagher of the Milwaukee Journal Sentinel.

Reporter Anita Weier wrote in the Wisconsin State Journal:

"The agreement will give the state a significant competitive edge over California and other states that have been investing heavily in stem cell research. Doyle hopes to lure research companies to the state in order to capture 10 percent of the national stem cell market by 2015."

On the topic of challenges to WARF's patents by two nonprofit groups, Gallagher quoted Beth Donley, WARF's attorney, as saying,

"I find it fairly hypocritical that California says things like 'They need to get the dollar signs out of their eyes' because we license our technology to raise money to fund our research.

"We're just doing it the Midwestern way: We made an invention, and we're licensing this technology to fund the research, rather than like in California, where they borrow $3 billion, then hope to make an invention and repay the money."

Jerry Flanagan is a health care advocate with the Foundation for Taxpayer and Consumers Rights, one of the nonprofit groups challenging the WARF patents.

Reacting to Doyle's move, he said,

"The agreement between Gov. Doyle and WARF is an acknowledgment that the overly broad WARF patents stymie research and delay cures. It is absurd that WARF, or any organization, could own the rights to life itself. For the good of patients, these patents must be dissolved."

Two Days and Two Very Different Stem Cell Conversations

Biopolitics, biocapital and, yes, even biopiracy were all part of the rhetoric at a stem cell and ethics conference in San Francisco on Friday.

This one was offered up by UC Berkeley and UC San Francisco and was a tad different than the egg risk conference staged a day earlier by the Institute of Medicine and CIRM, also in the San Francisco area.

The expression "biopiracy" was never heard at the CIRM session. It would have shocked the room of physicians and scientists. Yet in many ways the concerns were the same both days. "Do no harm" was heard more than once at the CIRM conference, which explored some of the obligations of the medical and science commnity to egg donors.

"What do we owe each other," was a central theme of the UC conference, according to historian David Rothman of Columbia University, one of its final speakers.

He noted that it is a question that would not have been asked at the time of the creation of the National Institutes of Health.

Our read, albeit sketchy, on the group at UC San Francisco on Friday was that many in it were generally hostile concerning the stem cell efforts at CIRM and elsewhere around the world. More so than the usual critics who turn up at CIRM meetings. We were told that two scientists had refused to appear before the group when it was trying to arrange speakers.

Given that environment, and to his credit, Arnold Kriegstein, director of the stem cell program at UC San Francisco, appeared as the final speaker. He acknowledged that one concern of stem cell researchers is fraud. "We seem to be blessed with more of it more than the rest of science," he said.

Kriegstein said his researchers are trying to perform their work in an ethical way, which he said requires vigilance in a fast-moving area such as stem cell research.

A video recording of the session was made on Friday along with what appeared to be a transcript. Hopefully, those will be available on the Web site of the Science, Technoloogy and Society Center at UC Berkeley, which sponsored the conference.

Kleffman's Coverage on Egg Risk is First Out of the Cyberspace Gate

Online news reports on today's egg risk conference came early. Reporter Sandy Kleffman of the Contra Costa Times wrote a piece that is now available on the Web, many hours before it will appear tomorrow in the recycled-tree version of the publication.

Here is her lead:

"The women who donate eggs to California's $3 billion stem cell research program may take great pride in serving as medical pioneers, but they could also face psychological and health risks that have not been fully explored by scientists, experts said Thursday.

"Many of the nation's top scholars in fertility and women's health gathered in Burlingame for an all-day hearing to assess how much is known about the risks egg donors face.

"Their conclusion: Many questions remain."

Scientists Call for More Study of Egg Donation Effects

The dome did not blow off the Capitol, so to speak, at today's much-heralded conference on the medical risks of egg donation.

Probably nobody really expected an explosion anyway. But the meeting did force attention on a difficult and controversial issue – one that needs considerable tending not only for the sake of the women donors but for the general cause of embryonic stem cell research.

The occasion was the Institute of Medicine's "Public Workshop on Assessing the Medical Risks of Human Oocyte Donation for Stem Cell Research" – a title almost as heavy as the subject.

CIRM instigated the meeting, seeking more input for its efforts to craft solid standards for stem cell research. And CIRM was paying attention. Several staffers were there and at least one Oversight Committee member. CIRM President Zach Hall opened the session and was there for the entire day, taking copious notes during the end-of-the-session summary by Linda Giudice, chair of the session and chair of the Department of Obstetrics, Gynecology and Reproductive Sciences at UC San Francisco.

The bottom line on the meeting: The process of extracting eggs has risks, but they are minimal, as understood by medical science at this point. But weaknesses exist in the current data, which primarily involve women who sought IVF because of fertility problems. More study needs to be done on "healthy" individuals who undergo the process solely for the purposes of donating eggs.

Giudice noted that despite 20 years of IVF in this country, not much is known on the health outcomes of those treated. "Varied" and "limited" are how she described the studies.

Giudice outlined some "challenges" facing scientists. They include differences in the way ovaries are stimulated to produce large amounts of eggs, finding alternate sources (possibly cadavers) and organization of the donation process.

While the meeting was devoted to medical issues, lying in the weeds were policy questions. Minimizing risk to donors can translate to changes in CIRM's research standards. And creating a database on the health of donors could be the focus of a CIRM grant.

The meeting was Webcast by the Institute of Medicine and presumably will be available online for viewing at your convenience at some point. CIRM had a court stenographer making a transcript which may be accessible online in a couple of weeks. And the California Stem Cell Report will have more on the session in the next few days.

Meanwhile, for those of you who were there or even those who were not, your comments or questions are invited. Just click on the word "comments" below. They can even be posted anonymously with your identity concealed even from the otherwise all-knowing California Stem Cell Report.

Multimillion Dollar Stem Cell Lab Building Program: The First Step

Building tens of millions of dollars in biomedical research facilities is the topic for next Monday's meeting of a working group of the California stem cell agency.

The Scientific and Medical Facilities Working Group will consider criteria for its initial grants which are likely to be approved early next year – upwards of $2 million per institution has been discussed at possibly 15 different locations. Funds would go for lab renovations and equipment.

Also on the agenda for the San Francisco meeting (no remote locations available) is a panel discussion on construction of biomedical research facilities. James Kovach, president of the Buck Institute on Aging; Rebekah Gladson, campus architect at UC Irvine, and Curtis Williams, vice president for capital construction, USC, are scheduled to take part.

The working group has 11 members. Six are patient advocates from the Oversight Committee. Four are real estate specialists, and the 11th is the chair of the Oversight Committee, Robert Klein, whose career has been in real estate development.

Egg Donation: 'People Think You Just Go In and Grab Some'

A day in the life of an egg donor:

"Somehow overcoming her fear of needles, (Julia) Thurman reported for a checkup midway through her regimen of ovary-stimulating shots. She felt fine, but her arms were tender from repeated blood draws -- four that week alone.

"A circle of red dots ringed her bellybutton, a calendar of shots past. Just below her bikini line was a greenish bruise.

"Four days later, the hormone surge was impossible to ignore. Thurman shuffled into the clinic, pale and slumping.

"'I don't feel very good today. My stomach hurts.' Her voice was flat. On the ride over, she thought she might throw up.

"'Is it your ovaries?' asked the doctor, Stephen Boyers, head of the division of reproductive endocrinology at UC Davis Medical Center.

"'It's my stomach.' She patted the spot.

"'That's your ovaries,'" Boyers replied.

"Thurman lay back for an ultrasound exam. Follicles showed on the computer screen as dark blobs like plums. 'These are ready,' the doctor pronounced."

That's an excerpt from an exceptional story by reporter Edie Lau of The Sacramento Bee on the experiences of one egg donor at the University of California at Davis. She followed a woman through the process, laying out the details in a vivid but restrained account. The name of the woman was changed in the article for privacy reasons.

Another excerpt:

"Thurman herself knew nothing at first of the arduous process called superovulation that drives the ovaries to produce up to dozens of eggs at one time. She did not know about the daily hormone shots in the stomach, how ovaries swell from the size of walnuts to the size of oranges or grapefruits, or of the 12-inch needle used to extract the eggs.

"Nor did she know about the hundreds of personal questions she'd have to answer during the screening, or the dozens of clinic visits required for invasive and uncomfortable tests and probes.

"More important, she did not know about the risks involved. Data about complications are scattered, inconsistent and incomplete, leaving even scientists without a full understanding of potential dangers.

"The lack of reliable information has spurred the state stem cell agency, the California Institute for Regenerative Medicine, to sponsor the first workshop on the subject. The meeting takes place Thursday in San Francisco."

The article was the result of cooperation between UC Davis and the woman involved. Lau wrote:

"Revealing a world usually hidden by medical confidentiality policies, the UC Davis Medical Center fertility clinic allowed The Bee to follow a donor through the process if she were not identified.

"Thurman agreed to share her experience so others could glimpse the complex procedure required to donate eggs. 'I think people think you just go in and grab some,' she said."

UC Davis and Thurman are to be commended for allowing Lau to pursue her story. Lau's perceptive reporting and restrained writing have added significantly to the discussion of women, eggs and stem cells.

Ortiz Legislation to Protect Egg Donors Signed Into Law

In a week when egg donations and stem cell ethics are the subject of some considerable attention, Gov. Schwarzenegger has signed the nation's first legislation aimed at protecting women who donate eggs for embryonic stem cell research.

The measure – SB1260 – was authored by Sen. Deborah Ortiz, who is one of the leading and early California advocates of stem cell research.

Marcy Darnovsky of the Center for Genetics and Society of Oakland, Ca., called the signing a "victory for women's health." She said,

"Similar provisions have been adopted as law in other countries and recommended as voluntary guidelines elsewhere in the United States, but the new California law is the first of its kind in the country."

Darnovsky continued:

"The passage of SB 1260 has taken on added importance because several biotechnology companies and research teams in California have begun experimenting with cloning techniques (known as somatic cell nuclear transfer or SCNT), which require large numbers of women’s eggs. An increasing number of scientists believe that if it is ever perfected, SCNT will be useful as an indirect research tool, not as the basis of medical treatments. But following revelations late last year of fabricated data and fraudulent claims of success by cloning researcher Woo Suk Hwang, what many have called a 'cloning race' has resumed.

"We hope that the Reproductive Health and Research bill is a step towards the consistent and comprehensive national regulation of stem cell research that the United States so urgently needs."

The bill signing comes two days before the CIRM conference on medical risks of egg donation and a UC Berkeley/UC San Francisco conference on stem cell ethics. (See separate items below.)

Ortiz' office summarized the measure, which deals with non-CIRM research, in a press release:

"SB 1260 ensures that women who are considering donating eggs for stem cell research are fully informed of the potential risks. The donors must provide written and oral consent before taking fertility or ovarian stimulation drugs and undergoing assisted oocyte production procedures. In accordance with the National Academy of Sciences, SB 1260 limits compensation to only allow reimbursement for direct expenses. This will ensure consistency between the procurement of eggs in California and other countries that have similar embryonic stem cell research programs and streamline international collaborations and the sharing of stem cell lines. It also ensures consistency with the limitations enacted in Proposition 71, the 2004 initiative that created the California Institute for Regenerative Medicine."

Ortiz said,

“Stem cell research holds great promise for chronic and life-threatening diseases that affect more than 100 million Americans. We all want biomedical research to move forward, but we must ensure that women who provide eggs for research are fully educated about potential reproductive health risks.”

Ortiz, a Sacramento Democrat, authored legislation in 2002 that made California the first state to authorize embryonic stem cell research. She is leaving the legislature this year because of a law that limits the number of terms an individual can hold office.

The Republican governor, who is in a campaign for re-election, buried the signing of the measure in a generic press release about a number of bills he signed related to women's health.

Here are links on the signing and the legislation: Ortiz press release, governor's press release, statement by Darnovsky, a text of the legislation and the last legislative analysis of the bill.

Coming Up

California legislation aimed at protecting women who donate eggs for stem cell research has been signed by the governor. We will have an item on it within the hour.

Live Webcast Set for CIRM Egg Donation Conference Thursday

For those of you who can't make the Institute of Medicine/CIRM daylong conference on the latest information on the medical risks of egg donation, you can catch all of it on a live Webcast.

The Thursday event is being held in San Francisco to "to assess and explore the nature and magnitude of risks, evaluating areas where more data are required, and assessing what is known about the potential for reducing risks through changes in procedures." Ethical and policy issues will not be a prime topic.

Advance registration is required for the conference, and the deadline is past, but you might be able to slip in. Here is the link to the registration site.

If not, the Webcast links will be active beginning at 7:30 a.m. PDT on Thursday. The institute advises that it is important to test your links in advance, which can be done at any time. See this site for details.

More Attention Needed to Public Needs in Stem Cell Research

More attention should be focused on the public obligations of embryonic stem cell research, says a UC Berkeley faculty member in an article in "Trends in Biotechnology."

David Winickoff, who is a discussant at a two-day stem cell and ethics conference later this week in the San Francisco Bay area, wrote:

"In the USA the selection of funding priorities, IP policies, a regime of egg donation in California, and other public initiatives will help set the national and international trajectory for hESC research. Considering the high stakes of these policies, more attention should focus on the public obligations of government-funded hESC research and its commitment to an equitable distribution of risks and benefits as policies are implemented. Taking a cue from the UK, centralized stem cell banking in California would bring general gains in efficiency and create a pragmatic opportunity to construct an ethical and legal architecture for long-term public return. This vision of stem cell banks as social infrastructure would provide useful flexibility in the face of a fast-evolving ethical frontier and help build trust between scientific institutions and society."

Winickoff, an assistant professor of bioethics and society, will appear on the panel on Friday at UC San Francisco on academy-industry alliances. Here is a link to the full schedule and other details.