CIRM and Stem Cell IP Hearings: A Cold Shoulder to the Public

Only four business days remain before the California stem cell agency takes another crack at who will benefit economically from inventions developed as the result of the $3 billion in taxpayer-supported research.

This is one of the major issues for CIRM this year. It is also the subject of separate legislative proceedings, including a proposed constitutional amendment, SCA13, by State Sen. Deborah Ortiz, D-Sacramento, that is on the floor of the State Senate. What California does this year will have an impact across the nation as other states also consider whether existing models for sharing the wealth are doing the job.

Despite the importance of the issue, no background material or proposed drafts of regulations can be found in the agenda of CIRM's Intellectual Property Task Force, as posted on the Web at the time of this writing. It simply says, "Consideration of draft IP Policy." Amazingly casual for a matter that could involve billions of dollars.

No draft of proposed regulations, much less a synopsis of what is under consideration. No explanation of whether the entire issue is on the table or whether particular subsets are to be considered. No links to previous material on the CIRM web site, which could have easily been done.

The scanty agenda of the IP task force is no exception. Generally, little or no material is available in a timely manner in advance of CIRM meetings. That makes it virtually impossible for interested parties or the public in general to prepare thoughtful comments on some very complex and important issues. All they have is three minutes at the end of the meeting to make some off-the-cuff observations. Even some members of the agency's Oversight Committee have complained about not having enough time to review agenda material because it is so tardy.

A cynic would conclude that CIRM is not interested in keeping affected parties even partially informed. Our opinion is that this is another example of the chronic cold-shoulder CIRM gives to much of its public disclosure responsibilities. The agency began business like this 12 months ago. Then it could be contributed to start-up problems. But it is past time for CIRM to fulfill its promise of adhering to highest standards of openness and transparency. Even small school districts in California do a better job of making their agenda material available online in advance of meetings. An agency that proposes to give away $3 billion must do better.

There is a new fillip to the task force's meeting, however. It will be accessible to the public in New York City at the Carlyle Hotel. One of the task force's members, former Hollywood executive Sherry Lansing, will be staying at the hotel and is going to participate via an audio hookup. The Carlyle describes itself as a "purveyor of privacy and a sanctuary of refined taste," but a CIRM official assures us that the public will be permitted to listen in on the deliberations. They also are likely to be allowed to speak during the public comment sessions.

The actual session of the task force meeting will take place at Stanford University. Other offsite locations for the 1 p.m. Jan. 23 session are in Elk Grove near Sacramento and UCLA. Specific room numbers are available in the agenda. We will carry the room number for the Carlyle when we receive it.

Additional material for the agenda may be posted by CIRM by this Friday. But for those of you who simply can’t wait, here are some links that will help to understand what CIRM is getting at. We should note that nearly all of the CIRM material comes from postings weeks after the date of the events. Moreover, even the text of CIRM's interim IP policy on training grants, approved more than a month ago is still not available online.

The transcript of the Dec. 6 meeting of the Oversight Committee. Discussion of IP begins on page 96.

The full transcript of the IP Task Force meeting Oct. 25.

The full transcript of the Nov. 22 IP Task Force meeting.

The full text of the National Research Council’s report: Reaping the Benefits of Genomic and Proteomic Research: Intellectual Property Rights, Innovation, and Public Health (2006). This is recommended reading by the chairman of the IP Task Force, Ed Penhoet.

Interim report on stem cell IP by the California Council on Science and Technology.

Draft of the interim policy for IP training grants presented at the December meeting of the Oversight Committee. This was approved with some slight modifications. The text of the approved policy is not available online at the time of this writing.
A host of material from the Oct. 31 hearing by Sen. Ortiz into intellectual property, including the transcript, background on Bayh-Dole and alternative intellectual property models.

Statement and testimony by the Center for Genetics and Society on CIRM Intellectual property policies.

Statements by the Foundation of Consumer and Taxpayer Rights on CIRM intellectual property policies.

The task force is composed of persons drawn from the CIRM Oversight Committee. They are: Edward Penhoet, chair; Susan Bryant, Michael Goldberg, Sherry Lansing, Ted Love, Philip Pizzo, Francisco Prieto, John Reed, Jeff Sheehy, Oswald Steward and Janet Wright.

Big Stem Cell Soiree Scheduled For San Francisco

If you want to pay $1,495, you can hear California stem cell chairman Robert Klein and CIRM president Zach Hall speak at The Stem Cell Meeting March 12-14 in San Francisco.

The Stem Cell Meeting (yes, that is its title) is being produced by Burrill & Company, a San Franciso life sciences merchant bank with more than $500 million under management.

Hall and Klein are among a host of impressive folks, including two representatives from Congress and biotech business execs and researchers, scheduled to appear at the conference at the Palace Hotel.

If you are interested in being one of the top sponsors of the conference – a $45,000 privilege – it looks you are probably too late. Only three were available and those slots seem to have been sold, based on what we saw on the web site for The Stem Cell Meeting.

If you want to see Klein and Hall in action for free, check them out at the next meeting of the CIRM Oversight Committee Feb. 10 in at Stanford.

It has always struck me as odd that public officials appear at gatherings that effectively bar the public from hearing them. However, it is not an uncommon practice.

New Stem Cell Links Added

We have added two new links to those carried on this blog. One is to the stem cell page of the Foundation for Taxpayer and Consumer Rights. The Santa Monica organization has a number of interesting items, including an analysis of CIRM's interim policy on intellectual property and a look at the conflicts of interest of the agency's Oversight Committee.

Also added to the links is the blog of the editors of the American Journal of Bioethics. The site is wide-ranging but includes interesting commentary and information on many of the issues confronting CIRM, although they may not relate them specifically to California. Its coverage of the Hwang scandal is especially useful.

We encourage you to take at look at the sites. Please send us suggestions for other sites that may be of interest to readers of these pages. You can do so by clicking on the word comments at the end of this item – it permits anonymous posts – or by sending a message to djensen@californiastemcellreport.com.

The Financial Message on Stem Cell Research

For the ethically challenged, a couple of business news outlets have pointed out another good reason for high stem cell research standards – money.

Without confidence in the research and its results, both big and small investors will shy from coming up with the cash that is necessary to turn research into therapies that will cure millions and generate billions in profits.

Both Business Week Online and Bloomberg News carried pieces on the financial impact of the Korean fraud.

The headline on the Bloomberg article, prepared by Heejin Koo and William Sim, said, "Fake Stem Cell Research Work May Cost Korean Industry Billions." The article noted that Hwang's research was once estimated to be worth $34 billion to the Korean stem cell industry by 2015.

Reporter Arlene Weintraub of Business Week Online wrote that the unsettled state of stem cell research has:

"...kept most venture capitalists away from anyone with the phrase 'stem cell' in their business plan. When the Korean scandal started erupting in December, shares of ACT(Advanced Cell Technology Inc.) fell 16 percent and rival Geron Corp. (NasdaqNM:GERN - News) tumbled 4 percent, despite the fact that interest in biotech was strong and the Amex Biotech Index was up 6 percent in the same period. Korea 'is just another body blow,' says ACT investor William Woodward of Santa Monica (Calif.)-based Anthem Venture Partners."

The piece noted the financial importance of articles in scientific journals.

"Geron's recent history reveals how much is at stake. On Sept. 1, the Menlo Park (Calif.) company announced that cardiac-muscle cells derived from human embryonic stem cells survived and multiplied in the hearts of rats, suggesting the cells might someday be useful for treating cardiac disease in humans. The research was published in the American Journal of Pathology. Geron's stock immediately traded up 3 percent to $11.20, on four times its normal trading volume. Such share-price bumps have allowed the company to go back to investors in a position of strength: It now has $200 million in cash and no debt."

Not mentioned in the Business Week piece was Geron's performance recently during the greatest attention to the Korean scandal. Geron's share price was $9.53 on Dec. 12. Since then it has dropped to $8.52 on Jan. 13.

Weintraub also wrote that the shaky state of commercial funding of stem cell research has led to some "contortions."

"When ACT decided to raise money by going public last year, investment bankers were so uninterested that the company opted instead to reverse-merge into a shell company that once made Hopi Indian dolls. It wasn't quite as splashy as an initial public offering, but the symbolism was perfect: The dolls represent ancestral spirits to whom the Hopis pray for rain and other gifts. New shares in hand, ACT raised $18 million from hedge funds and other risk-taking investors -- enough to carry the company into 2007. But the spirits didn't smile on this stock, which fell from a high of $7 to a recent $1.90 a share."

Nonetheless, Lanza still has a Hopi doll of a red-tailed hawk in his office.

California Stem Cell Research: Hype, Folly and Contempt?

If you believe a Washington Post editorial and an op-ed piece in the San Francisco Chronicle this weekend, California should fold up its stem cell research rather than capitulate "to "the unholy lust of scientists."

Citing the Korean scandal, self-described "professional philosopher" David S. Odeberg called for separation of science and state in his piece in the Chronicle.

"How could the millions thrown at scientists be anything other than a veritable inducement to misconduct? When you combine it with the innumerable honors and awards that await the next would-be secular savior of humanity, one wonders that fraud is not even more common than it appears to be," he wrote.

Odeberg, professor of philosophy at the University of Reading, England, continued:

"It would be an act of utter folly and of contempt for honesty and integrity were Gov. Arnold Schwarzenegger's beloved California Institute for Regenerative Medicine now to go ahead."

The Washington Post, whose editorial was carried on some California websites, also noted the pressures on scientists to overstate their results. But its main argument was that states are a "bad place" to conduct stem cell research because it would be politicized at the state level.

"In California, universities already are hiring scientists and building labs, even though lawsuits have prevented the state's $3 billion funding program from issuing any grants. This kind of hype makes it particularly difficult for states, which do little basic research funding, to judge the value of individual stem cell research projects."

The Post did not mention that the reason states are seeking to fund embryonic stem cell research is because of the President's own politics and personal beliefs and the political gridlock in Congress on the issue.

Bioethics Blog Disagrees with CIRM Exec

The editors blog of the American Journal of Bioethics does not agree with the position of Zach Hall, president of CIRM, that peer review can prevent a Korean-type scandal in California.

Here's the key quote:

"This from the guy who is giving out the money. Oversight is the key to giving the money out responsibly. It is one of the reasons why we should give government funding in the first place. California has become the standard-bearer for state-based biotechnology research funding…."

This would be okay, "but not if the standard-bearer claims that fraud is best prevented by peer review."

Chronicle: CIRM Needs Careful Regulation

The San Francisco Chronicle said today the Korean stem cell scandal is a “cautionary tale” that shows that the California stem cell agency needs additional public regulation.

The editorial in today’s paper said:

"What is to prevent similar fraud and ethical lapses from happening here in California, where voters agreed to spend $3 billion on stem-cell research?
"'Scientists,' responded Zach Hall, president of the California Institute for Regenerative Medicine, the funding entity created by Prop. 71. Warning that every industry has the potential for an Enron, Hall touted the American system of peer review as the best way to expose rogue scientists and bad science and to keep research-funding decisions apart from undue political, religious or geographic influences. 'What will not stop this from happening is government oversight,' he said.
"In a world of 'pure' science, maybe. But stem-cell research is, at this point, anything but pure. Scientists rail about the 'political'interference in their work by the religious-right aligned Bush administration, but what was the campaign launched by the stem-cell research proponents to sell the stem-cell bonds, if not political? With business and political capital -- not to mention the state's image as a technological innovator -- on the line, the stem-cell institute needs oversight, both regulatory and scientific."

The editorial continued:

"Questions remain about the sourcing of the human eggs and about which avenues of research are best pursued with the taxpayers' money. Would voters embrace research that might require hundreds of human eggs to produce a therapy for a single person? If these rules are adopted, who enforces them? Are there punishments for infractions?
"These matters of great public concern should be subject to government regulation -- especially when taxpayers are picking up the multi-billion-dollar tab for this research."

New Money-Raising Effort at CIRM

The California stem cell agency began a new, $2 million fundraising drive yesterday to pay for such things as a national conference in May on the medical risks of human egg donations and how to reduce them, according to the San Diego Union Tribune.

Reporter Terri Somers quoted Zach Hall, president of CIRM, as saying the effort is aimed at financing “nongrant” scientific activity. Hall also said the agency is now focusing on creating a structure that will allow it to move quickly once litigation against it is resolved.

"We want to hit the ground running once the money comes in. Rather than sending out a slow and gradual stream of funding, the plan now is to let a torrent of funding flow like waters set free from a sluice gate."

Somers wrote that the “image of a torrent worries” Jesse Reynolds of the Center for Genetics and Society.

“He wondered if there was enough good science to warrant such funding at this time. But he was also somewhat comforted by the plan.
“Originally, the institute's leaders talked about making their first grants last May, which Reynolds said was ludicrous. To hear them now talking about having their organizational infrastructure in place first sounds better, he said.”

The latest fundraising effort is in addition to the $50 million effort to sell bond anticipation notes.

CIRM, Cibelli, Korea and The Bee

An official of the California stem cell agency is taking issue with a Sacramento Bee editorial that indicated that CIRM was not taking the Korean scandal sufficiently seriously.

The editorial referred to a meeting Dec. 1 of the Standards Working Group. At that time, the Hwang affair had not surfaced completely, but it was evident that extremely serious problems existed.

Bernard Lo, co-chair of the group and director of the UC San Francisco Program in Medical Ethics, said in his letter:

"Contrary to the assertion that we went 'out of our way' to avoid discussion of Hwang's difficulties, a review of the written record of the Dec. 1 meeting of this committee, posted on Dec. 12, demonstrates that the Korean developments were the catalysts for extensive discussion on egg donation. The result was numerous recommendations to prohibit the practices that sparked the Korean controversy. Further, we have developed enforceable rules that exceed existing state and federal guidelines to ensure that research is conducted safely and ethically."

A search of the 263-page transcript shows that the word "Hwang" was mentioned twice and "Korea" or variations of it popped up eight times. Obviously such a simple count does not measure the quality of the discussion. Korea did trigger some exchanges, and the group also discussed a wide range of ethical subjects, including the value of a woman's eggs.

One of the members of the standards group is Jose Cibelli, a reknown Michigan State University scientist. He is also a co-author of the fraudulent March 2004 paper by Hwang that reported the first-ever closed human stem-cell line. Cibelli was present at the December meeting and participated in the discussions.

Queried by the California Stem Cell Report, a spokeswoman for Michigan State said,

"Michigan State University is conducting an investigation into Dr. Cibelli’s role on the '04 paper, where he is listed as a co-author. The investigation was started at Dr. Cibelli’s request. Given the investigation, there won’t be any comment available. For more information on the process, see: http://www.msu.edu/unit/vprgs/level2/conductres.htm

We should note that CIRM officials have stated in the past that scientists are often reluctant to criticize their peers' work in public. It is one of their justifications for maintaining closed door reviews of grant applications.

California Pushing Ahead with Cloning ESC

From San Diego, where stem cells meet the surf(see "Science of Surfing"), comes a couple of stories dealing with the California stem cell agency and some of the California fallout from the Korean scandal.

Reporter Terri Somers of the San Diego Union-Tribune wrote in some detail about the plans of California scientists to jump into the field of cloning human embryonic stem cells. It was that effort in Korea that turned out to be frauduent.

But scientists in California aren't giving up, and they hope to secure funds from the California stem cell agency to pursue their work.

Somers wrote:

"My guess is that just about everyone who has a stem cell research center is going to jump into this," said Jeanne Loring, a stem cell researcher at the Burnham Institute in La Jolla.

"All of the California research institutes stressed that in moving forward, they will follow the latest and strictest ethical guidelines to avoid the lapses uncovered in South Korea."

Also weighing in from San Diego was Richard Murphy, president of the Salk Institute and a member of the Oversight Committee for CIRM. His op-ed piece in the San Diego paper was a reprise of CIRM one year later. He said:

"I am often asked when California's stem cell research is going to get off the ground. The answer is, we don't know. At the moment, state-supported human embryonic stem cell research is at a standstill, tied up in the courts by research opponents who are arguing that Proposition 71 is unconstitutional.

"But these opponents have not succeeded in preventing CIRM's employees from creating an impressive state-supported stem cell institute that is ready to spring into action once the monies flow. Government agencies are often targets for criticism, but Californians are getting more than their money's worth from this one."

IP, IP, IP and More IP

The website of the Health Committee of the California state Senate is awash in intellectual property – that is, information dealing with the multimillion dollar questions of who profits from research funded by the California stem cell agency.

The Health Committee is chaired by Sen. Deborah Ortiz, D-Sacramento, who is carrying a proposed constitutional amendment concerning IP and CIRM. So much of the information comes from her hearing last Oct. 31, including a transcript of the proceedings.

But there are additional links to to background information at the University of California, the NIH, the California Council on Science and Technology and alternative IP models. Also included is information from last March's hearing into implementation of Prop. 71 and a hearing on the measure prior to its passage in November 2004.

If you want to know what is going on with IP issues and CIRM, this is one of the places you need to check out.

Vaccine Advisory

For those of you who have been looking for the "sunshine vaccine" item, it has been reposted a couple of items below. It was inadvertently removed during a feeble attempt to fix some html coding errors.

Hwang Reaction: Research Needs More Care

In the first of what is likely to be a series of comments about the impact of the Korean stem cell fraud findings, a top Stanford researcher says they show that researchers must "work more deliberately."

Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine, released a statement that included the following:

"With the dollars provided by California's Proposition 71, Stanford intends to recruit scientists who will find ways to do nuclear transfer research, first in animal models and then with human cells, using the safest and most effective methods.

"The Stanford Institute for Stem Cell Biology and Regenerative Medicine is committed to advancing the field through the creation of new stem cell lines, research to further understand stem cell biology and the development of treatments for disease. Proposition 71 will play a significant role in helping Stanford researchers as well as other California institutions achieve the full therapeutic potential of stem cells."

Weissman called the Korean scandal a "personal tragedy" for Hwang and his scientific colleagues.

"While the announcement is a disappointing setback for nuclear transfer stem cell research, we are all making significant progress in the fields of adult tissue stem cell research, embryonic stem cell research and cancer/leukemia stem cell research. We must work more deliberately on nuclear transfer stem cell research, but we must go forward ethically and responsibly, as the future potential applications for the diagnosis and treatment of human diseases using these tools is so great," Weissman said.

CIRM Promises Open Search on General Counsel

After we posted the item below, the California stem cell agency emailed the following comment on Bedford's position at CIRM.

"CIRM will engage in a full and open recruitment process for the position of General Counsel when our funds become available."

Update on CIRM's General Counsel: An Orrick Connection

The California stem cell agency may have found the man who will be its new general counsel once the money really starts rolling in.

He is Daniel R. Bedford who is working fulltime pro bono at CIRM while he winds up affairs at Orrick, Herrington & Sutcliffe LLP of San Francisco.

It is our understanding that Bedford will fill the general counsel slot at a later point, but neither he nor CIRM would confirm that. Currently CIRM has put a hold on new hiring because of its budget crunch.

Bedford is assisting "CIRM generally on its many legal matters," says Nicole Pagano, a spokeswoman for CIRM. "At the moment most of his time is devoted to helping CIRM put together its Grants Administration Policy and advising on internal governance questions."

According to Orrick's web site, Bedford focused his practice on complex asset-based and lease financing, with an emphasis on agribusiness, domestic and international project financing, and tax-advantaged leasing."

His work has included representation of John Hancock Life Insurance in areas concerning equity and debt direct private placements. Other clients included public transit districts and Banc of America Securities. Much of his work involved various kinds of debt, which would seem to be a good fit with the needs of CIRM in connection with the issuance of state bonds.

Bedford has also participated in complex negotiations for natural gas pipelines involving government agencies, both in the US and involving Argentina, Chile, Brazil and Bolivia. Orrick's site did not list any involvement with biotech firms.

Orrick is bond counsel to California, but Orrick's site does not show any work by Bedford for the state.

Bedford received a B.S., M.B.A. and J.D. from Stanford University, where he was a member of Phi Beta Kappa.

Time for a Stem Cell Sunshine Vaccine

The international scientific conference that was sponsored last fall by the California stem cell agency had an interesting sidelight that is now surfacing in the Korean research scandal.

It was in San Francisco at the time of the conference that Gerald Schatten, the University of Pittsburgh scientist who co-authored the fraudulent Korean stem cell paper, met with Hwang Woo-suk and asked for a 50 percent share of the patent, according to Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest.

Hwang rejected Schatten's request. About six weeks later Schatten publicly broke with Hwang, helping to set in motion a string of events that culminated in Hwang's disgrace.

The rejected request by Schatten has been reported previously (Nov. 29), although we had not seen the location of the meeting. But as Goozner notes, it has received little notice in American media. Goozner also points to a story on Saturday by reporter Jennifer Bails of the Pittsburgh Tribune-Review, who wrote that Schatten "is seeking to patent technology to create embryonic stem cells without crediting his now-estranged colleagues in South Korea."

The 50-percent request is not the only allegation about Schatten that has received little scrutiny. Totally overlooked by most newspapers was a report Dec. 16 by Associated Press writer Paul Elias. He wrote that Schatten, who was listed as "senior author" on the Hwang paper, could also become a victim of the Korean scandal.

"At the very least, Schatten faces a formal reprimand once an internal school investigation is concluded," Elias said.

He quoted Arthur Levine, dean of Pitt medical school, as saying:

"One should only be the senior author of a scientific paper when one has prepared and was responsible for all the data in that paper. It also implies the senior author is the chief of the lab where the experiment took place."

Other allegations concerning Schatten have also received short shrift in this country. They include aKorean statement that Hwang rejected Schatten's request to serve as chair of the once-vaunted World Stem Cell Hub. Hwang also reportedly rejected a Schatten request for a payment of $200,000 to help start the US operations of the World Stem Cell Hub, according to Digital Chosun.

Schatten and Pitt have generally not responded to the allegations. Pitt is conducting its inquiry behind closed doors, a process Goozner called outrageous.

Bails wrote:

"The rush to file biomedical patents for early-stage technologies creates roadblocks to research that do a disservice to the public by requiring scientists to dish out licensing money whenever they have an idea that might be worth pursuing, Goozner said.
"'It sets up arbitrary financial roadblocks to research,' Goozner said. 'We need new systems that make these technologies open to all scientists at the lowest possible price, and when the government funds them, it should be the government insisting that's how they are managed.'"

In his blog, Goozner wrote that Hwang was also attempting to patent the same research without mentioning Schatten.

"Ownership disputes over key stem cell patents have been simmering since the field emerged in the late 1990s. The University of Wisconsin, whose researcher James Thomson used Geron Corp. funding to isolate the first embryonic stem cell lines, charges $100,000 to commercial concerns and $5,000 to academics for access to those lines. It also granted Geron exclusive rights to pursue therapies in the most promising fields. Last May, San Diego-based stem cell researcher Jeanne Loring told Nature magazine her start-up firm collapsed because it couldn’t get access to the Wisconsin patents at reasonable rates," Goozner said.

In the case of Hwang, however, one wonders why someone would want to patent bogus research results.

Aside from the San Francisco meeting between Hwang and Schatten, what does all this have to do with CIRM? Much of it goes right to the point of the hottest issues before CIRM this year. The agency, as well as the legislature, is in the midst of wrestling with the question of ownership of state-funded research results and sharing access to those results. The fallout is likely to build support for more sharing rather than less. The Korean scandal also reminds us that the stakes are huge and people are tempted by riches and fame. It tells us that more disclosure is better than less about the economic interests of those associated with the $3 billion California effort. Call disclosure a kind of sunshine vaccine. Without some protections such as could be provided by a pending state constitutional amendment, the CIRM program would not likely survive a scandal of even a fraction of the magnitude of the Korean affair.

Why Whales Migrate

When two U.S. scientists decided to take their research to Singapore last fall, one Stanford stem cell researcher called it a "loss for America."

The two are Neal Copeland and Nancy Jenkins. They left the National Institute of Cancer in Maryland and rejected a pitch from Stanford as well before deciding to depart for Asia.

They said they would have moved to California if funds were available from the state's stem cell agency. Writers Sara Webb and Mia Shanley of Reuters recently explored more of the couple's reasons for leaving the Home of the Free and the Land of the Brave. They included "restrictions on government funding for stem cell research, shrivelling grants and curbs on commercial spin-offs from their work such as consulting and other fees," the scientists told Reuters.

The news agency reported:

"'The amount of money going towards research is going down. It doesn't have a high priority (in the United States). In Singapore it does," said Copeland, adding that they would like to exploit some of their Singapore-funded research commercially.
"Copeland and Jenkins said they had been won over by Singapore's scientific freedom, deep pockets and interest in commercial applications, at a time when the U.S. government's National Cancer Institute in Maryland -- where they worked for 20 years -- began a clamp down on consulting work by its scientists."
The story continued:
"In an era where funding is critical -- even a microscope can cost half a million dollars -- wealthy Singapore has the money.
"That, say scientists, has been Singapore's attraction, along with speedy grant approvals and lack of burdensome paperwork.
"'We don't want to spend the rest of our lives writing grants,' said Copeland, adding that Singapore's quick access to funding was key. The couple's colony of 20,000 mice costs some $1 million a year to maintain."

Singapore is currently engaged in a major recruitment drive to attract top scientists – "whales"-- as part of a multi-billion dollar biomedical research effort. Last fall reporter Lisa Krieger of the San Jose Mercury News wrote about the couple's decision. Irving Weissman, director of Stanford's Institute for Cancer/Stem Cell Biology and Medicine, told Krieger:

"'It is a loss for Stanford and a loss for America,' Weissman said. 'Without a doubt, they are the best people I know to find out which genes are altered to cause cancer.
"'When they do their work, it will be for Singapore,' he said. 'They'll conduct their clinical trials in Singapore. The first place their work will be patented and used will be Singapore.'"

Studying the Science of Surfing

It's just like science say the biotech "dudes" who combine business and surfing in the Pacific Ocean near San Diego.

"In San Diego's booming biomedical industry, opportunity tends to come in waves — the kind found at La Jolla Shores or Black's Beach or Scripps Pier. Surfing has become a way to make contacts, get face time with the boss and arrange deals," wrote reporter Denise Gellene in the Los Angeles Times on Sunday.

They call them "board" meetings and report that "it's where the best business gets done." One surfer, Steve Mayfield, named his company, Rincon Pharmaceuticals Inc., after a surfing spot somewhat farther north on the California coast. Mayfield is also an associate professor of cell biology at the Scripps Research Institute.

Laura Shawver, chief executive of Phenomix Corp., said riding the waves has something in common with biotech.

"This is just like science. You must be very persistent. You can have spectacular wipeouts followed by the high of your life. And you are always looking for the next one."

We should report that we surfed a spot in La Jolla early in December but did not see any major stem cell breakthroughs or deals being hatched. But again it is about being in the right place at the right time.

California Researchers Forging Ahead with SCNT -- Among Others

Newsweek had something to say in its most recent edition (dated Jan. 16) on the impact of the Korean scandal on stem cell research in California as well as elsewhere.

Here are the most pertinent paragraphs in the item written Claudia Kalb and B.J. Lee:

"The Hwang debacle isn't stopping U.S. scientists. Nor are they starting from scratch. Somatic cell nuclear transfer (SCNT)—the technique Hwang claimed to have mastered in humans—has already been accomplished in mice. If researchers can move it to people, they say SCNT will allow them to watch complex diseases develop in the petri dish, spot problems and then test drugs to fix them.
"The procedure, which requires human eggs, is technically daunting and only a handful of U.S. scientists have said they have plans to try it. Three from Harvard, who specialize in diabetes and brain and blood diseases, hope to start experiments soon. The biotech firm Advanced Cell Technology, in Worcester, Mass., says it's moving ahead again after shutting down in the wake of South Korea's supposed advance. Stanford says it's recruiting scientists to work on the procedure. And last week, Larry Goldstein of the University of California, San Diego, went public, telling NEWSWEEK that he and several colleagues now plan to pursue SCNT as well. A politically active stem-cell researcher—he fought hard for California's $3 billion initiative—Goldstein wants to use the technique to focus on the genetic underpinnings of Alzheimer's: 'It's a unique approach to understanding disease.'"

Correction

On Jan. 4 in the "eggs and ethics" item, we made an incorrect reference to the "Center for Policy and Genetics." The correct reference is to the Center for Genetics and Society. We are told that we have done this in the past, much to our regret -- the error -- not the criticism. We can only attribute it to a synapse breakdown.

Our policy is to correct all errors. We do not want to repeat them. If you see a mistake, please call them to our attention by sending an email to djensen@californiastemcellreport.com. Or you can post it directly online by clicking on the word "comment" at the end of each item.

San Diego Voice: Don't Tar California Stem Cell Effort

From San Diego, one of the hotbeds for stem cell research, comes an appeal to the public to not paint California's efforts with a Korean brush.

The pitch was made by Elie A. Shneour, president of Biosystems Institutes, Inc. and research director of Biosystems Research Institute of San Diego

Writing in the Voice of San Diego, an online news outlet in that area, he said,

"California in general, and San Diego in particular are directly affected by the fallouts of this debacle. It has to do with damage to the credibility of the stem cell enterprise, and the trust of the public in the funding of scientific research. But it should not be."

He continued:

"What happened in South Korea unjustifiably reverberates in California, but it should not create one more unmerited impediment to an already charged situation."

Shneour went on to praise the work of the agency and said:

"Unfortunately, this grand project is now mired in legal conflicts generated by politically and religiously motivated antagonism that mirrors the resistance of Washington to stem cell research."

"Disappointingly, California, a state that has always been at the forefront of progress, is allowing the uninformed and the fearful to deny it the opportunity to take one of the first steps."

.

Wilson Cites Other Commitments

According to CIRM, Gayle Wilson left the Oversight Committee of the California stem cell agency because "her other commitments have shifted in the last year and she is unable to devote the full time and attention necessary to participate fully as a member of the ICOC."

That was the response from Nicole Pagano, spokeswoman for the agency.

Gayle Wilson Leaves Oversight Committee

Gayle Wilson, the wife of former California Gov. Pete Wilson, has resigned from the Oversight Committee of the California stem cell agency.

Wilson's resignation took effect last Sunday, according to a press release from CIRM. The statement said she will "continue to advise CIRM leadership on state and federal legislative matters." The reason for her departure was not disclosed in the press release, but we have a query into the agency.

Wilson was appointed to the board by Gov. Schwarzenegger as a representative to a committee slot for "an executive officer of a commercial life science entity." She is serves on the board of Gilead Sciences, as biopharmaceutical company.

Stem cell chairman Robert Klein said, "Her outreach efforts to fully inform the stem cell debate in Washington D.C. have been invaluable-especially in moving pro-stem cell legislation forward and with advancing a scientific understanding of stem cell research and its promise for treating chronic disease."

Wilson is the second person to leave the Oversight Committee. Phyliss Preciado left in the middle of 2005 to take a job in Oregon.

Eggs, Ethics and Cash: What about Singapore?

What is the price for a woman's egg? Is it more or less than a man's sperm? Is an egg worth more than the $30 paid to the donor of a pint of blood? Is it worth more than a kidney, for which the official price is zero?

Some of the questions that are being discussed by the California stem cell agency as it develops rules for securing eggs for its taxpayer-funded research.

Prop. 71 prohibits paying women to provide eggs, beyond direct expenses. But the agency is trying determine whether eggs can be used that come from sources outside of California that may involve some sort of additional payment. The Center for Policy and Genetics says that many members of the CIRM's Standards Working Group have "advocated seizing on a potential loophole in Prop. 71," asserting that "compensation for egg providers would be legal as long as the funds for these payments came from a source other than the CIRM."

The topic of cash-for-eggs came up at the group's meeting in December. The meeting received no coverage in the media but was attended by a staffer from the Center. The Korean scandal, which involved payments of $1,400 for a human eggs, was discussed during the meeting, although the flap was in its early stages.

The transcript of the meeting shows a free-ranging and loose discussion of some of the considerations involving the use of human eggs. Often in such discussions, the beginning question is phrased as "should we pay women to donate their eggs?" Rarely is it phrased as "should women be allowed to sell their eggs?" The different starting points could lead to different conclusions.

Here is a semi-random sampling of some of the partial comments from members of the Standards Group as carried in the transcript of the meeting.

Ann Kiessling, director of the Bedford Stem Cell Research Association and associate professor of surgery at Harvard Medical School

"I think that in the consenting process itself, you cannot establish guidelines for people in Singapore or other parts of the world who may actually view this as a way for women to get together and actually create a small business to donate eggs. I don't think that should be absolutely prevented. What you want to prevent is having somebody go through this procedure who was not fully informed and not doing it of their own free will."

Zach Hall, president of CIRM

"The question is do we want to exclude cell lines that are made by well-meaning, thoughtful, responsible people who happen to come to a different conclusion for whatever reasons than we do on this particular issue?"

Kiessling, again

"Lots and lots of women are going to be willing to do this because they're going to be willing to do it. It's going to be a select group. You are not going to recruit people who can't afford to take off two weeks to do it... Plenty of women...are going to volunteer to donate eggs because women do things like that. That's not the issue. The problem is whether you ought to accept lines from other parts of the world or other parts of the country that have different guidelines."

Marcy Feit, president of ValleyCare Health Systems

"(Say)there's a cell bank in Singapore. What assurances do we have that even if we get paperwork that says informed consent was given, how do we validate the process of informed consent? Many times cultures work under different understandings of processes than we do. And so I think we have to give really careful consideration to lines that were derived before our standards were set in. And I'm not saying I have the answer of how we're going to go about that because I hear the plea from the scientists that you really want to include as many lines as possible that are usable for research. But given that, the attack on CIRM would be vicious internationally if we accepted one cell line that wasn't properly handled in another country. So to validate that process, to really understand, as much discussion as we had this morning regarding protecting women, and we know what we want, how do we validate that with cell lines that were created prior to this understanding this morning?"

The discussion turned to the value of eggs in dollars and cents.

Kevin Eggan, assistant professor of molecular and cellular biology at Harvard and a founding member of the Stowers Medical Institute

"The problem here is that...eggs somehow lie somewhere between blood and sperm
and a kidney. "

Robert Taylor, associate professor of medicine at Emory University

"So I'm having trouble following this argument. So the liver donor gets nothing.The kidney donor gets nothing. The sperm donor get $75 or something like that.The blood donor who has probably a slightly higher risk of injury than the sperm donor, which I would say is probably relatively minimal risk last time I thought about it, gets compensated to the tune of $30. I'm just -- I'm starting to -- so cost and risk clearly are either dissociated or inversely related. I can't figure this."

The topic of eggs and ethics is expected to be revisited later this month at a two-day meeting of the Standards Working Group.

CIRM President On Cyberspace Airwaves Jan. 4

Set your Internet radio Wednesday Jan. 4 to Science and Society at 1 p.m. PST to catch the president of the California stem cell agency discussing the latest doings at the institute.

Zach Hall is scheduled to be interviewed on a program called Science and Society by David Lemberg. The program's website says it provides "direct access to primary sources of change in science and technology." It is also a public service of the Hopkins Capital Group, a St. Louis venture capital firm focusing on high tech health firms.

California Universities Not Waiting for CIRM Cash

California universities are plunging ahead with multimillion dollar stem cell programs despite the failure – so far – of the California stem cell agency to deliver on promised grants.

That's the report in the Los Angeles Times this morning by writer Rong-Gong Lin II.

According to the story:

"'We are … not waiting,' said Arnold Kriegstein, director of UC San Francisco's stem cell institute, which has also hired faculty and started preparing research facilities. 'We are moving ahead with what we can with private funding.'"

The Times said that UC San Francisco officials are using private fundraising to renovate about 7,000 square feet of lab space, expected to be ready in 10 to 11 months for new embryonic stem cell lines not approved by the federal government.

The story also said, however:

"Some (UCSF) researchers who had been eager to compete for grants for embryonic stem cell research have had to look for other sources of funding or areas of emphasis. Programs to train scientists in developing and maintaining human embryonic stem cells have stalled."

Here is the Times look at other schools:

"USC has lured a top scientist from the Australian Stem Cell Centre to head its new research institute and has committed $10 million this year to hiring faculty and renovating lab space." He is Martin F. Pera, whose lab was the second in the world to isolate embryonic stem cells from the human blastocyst, a developing embryo.

"UCLA has said it will spend at least $20 million over five years to recruit scientists and set up laboratories. It has already hired three young researchers for faculty positions, two from Harvard University and the other from Massachusetts Institute of Technology." The Times identified three of the hires as Hanna Mikkola, who is focusing on leukemia; Kathrin Plath, who was at the Whitehead Institute for Biomedical Research at MIT and is studying the biology of how stem cells differentiate; and Amander Clark from UC San Francisco, who wants to see how stem cell research can help improve human fertility

"Stanford University has made several prominent hires, including two in May from Harvard and the University of Michigan. UC Irvine has begun planning a $60-million facility to house its program, and on Friday hired Peter Donovan, a prominent Johns Hopkins University professor, as an interim co-director."

Separately from the Times article, John Simpson, stem cell projector director for the Foundation for Taxpayer and Consumer Rights in Santa Monica, commented on the hiring of Pera, but his remarks apply to the others as well:

"This just shows that Prop. 71 is having worldwide impact and that California is becoming the model for publicly funded stem cell research. If the ICOC is to fulfill the promises made to the voters, CIRM polices need to be grounded on three principles: affordability, accessibility and accountability."

Stem Cell Matters Moving Into Gubernatorial Campaign

You might call him Stem Cell Steve. He is the only major candidate for governor of California with a section of his website devoted to stem cell issues.

He is Steve Westly, the elected controller of the state of California. Westly is running for the Democratic nomination for governor against Phil Angelides, who is the elected state treasurer.

The position of controller is pretty much a ho-hum office, hardly worth more than the proverbial bucket of warm spit, as a former vice president of the United States once described his own office. It is difficult to electrify the electorate when your main responsibilities as controller are primarily printing state payroll checks and dealing with "fiscal year-end procedures."

Only one California controller has managed to make it into the governor's office, Gray Davis, who was a colleague of ours some 30 years ago.

We ran across Westly's interest in stem cell matters when we saw a Google ad bearing his name on this web site. That means the Westly campaign is paying Google to place ads on sites that deal with stem cell issues.

(For the record: We -- the California Stem Cell Report -- do not have any control over which ads Google places on our pages. We do not receive any revenue from Google unless someone happens to click on Westly's ad or any of the others that may appear. Even then the amounts are inconsequential or less. Since Google ads began appearing on this blog in early 2005, we have not received one cent from the advertising. We hesitate to speculate about what that means.)

Westly's ad makes a pitch. "Stem cell research – why it's held up and how you can help," it reads. The ad contains a link that takes the curious to a section on Westly's campaign website called "Stem Cell Research Now!" It targets Gov. Schwarzenegger as allied with opponents of stem cell research who have sued the stem cell agency. Here is what it says:

"Right-wing troublemakers Ted Costa and Lew Uhler are behind the lawsuit. They also happen to be - surprise, surprise - two of Governor Schwarzenegger's biggest backers. Costa led the recall and Prop. 77 drives. Uhler was behind the union dues initiative, Prop. 75.

"So why doesn't the Governor call off his conservative cronies? Millions of people are waiting for cures. Stem cells may be the fastest way to get those cures. And Arnold's buddies are holding up the research."

The pitch includes an electronic petition that is designed to be sent to the governor with the electronic addition of a signature and email address from whomever may be viewing the site, whether they live in Korea or South Dakota. Our suspicion is that the petition, if it ever gets delivered, would contain no names from Korea. The Westly effort is undoubtedly designed to identify probable Westly supporters who are interested in stem cell research. Once identified, they can be targeted later for more specific pitches in support of Westly.

Westly's rival for the Democratic nomination, Angelides, does not have a similar focus on stem cell issues. One can only speculate on the stem cell strategy in Westly's campaign. But here is one theory: Westly's people read polls that say the public supports stem cell research. If the public knows Westly supports the research, that will generate voter approval. It will generate even more voter approval if the evil Gov. Gropenator is linked with the Luddites who oppose stem cell research and are suing to prevent it. Further, attacking the governor at this stage could also help weaken him in next fall's general election. Or so the reasoning may go.

We should note that Westly is a former top executive at eBay and has close links to the Silicon Valley financial community, which was a big supporter of Prop. 71. California stem cell chairman Robert Klein also donated $27,695 to Westly's campaign for controller, according to one report.

More Cash for CIRM This Month?

The financially hard-pressed California stem cell agency hopes to get a boost this month with the sale of bond anticipation notes to philanthropic investors.

Reporter Laura Mecoy of The Sacramento Bee quoted Zach Hall, president of CIRM, as saying that the agency hopes to secure enough funding by the end of January to move forward on some of the training grants it approved in September.

No money has been available for grants because litigation against the agency has made it unable to issue the $3 billion in bonds that voters authorized more than a year ago. The lawsuits are not expected to be resolved until 2007.

Mecoy's story Sunday morning also reported that the agency is "trying to determine whether state-funded research can use stem cell lines developed by other agencies that allow larger donor payments" than permitted under Prop. 71, which limits egg donor payments to reimbursement for expenses.

"There are other entities in other countries that operate in other ways. If we insist everybody do as our regulations say, our scientists will not be able to work on (stem cell) lines that deviate from our standards," Hall said.

The main focus of Mecoy's story was on the impact of the Korean scandal on legislation by State Sen. Deborah Ortiz, D-Sacramento, to tighten oversight of the stem cell agency, which we discussed on Dec. 20 (Christmas Comes Early for Sen. Ortiz).

Mecoy wrote:

"'The South Korean scandal makes it more difficult for opponents to allege this is a plot by the right wing,' Ortiz said of her legislation. 'It shows the best and the brightest in the scientific community couldn't catch these instances of fraud and overstated research.'"

Mecoy continued:

"'If their industry can't sufficiently police themselves and root out fraud, then government should step in,' the senator said. 'California would be leading the nation if we did the right thing.'

"Hall said the South Korean scandal 'emphasizes the importance of just the type of apparatus we are putting together' at the stem cell agency.

"But he said fraud is not unique to stem cell research: It has happened in various fields of scientific endeavor.

"'These things happen,' he said. 'The more intense the interest, the more likely they are to happen, and the more likely they are to be found out.'"

Regarding the sale of the bond anticipation notes, agency officials earlier said they hoped for funding last fall so we will have to wait and see whether the current expectations materialize. Agency officials have been circumspect on any pending deals, but on Oct. 31, an official from the state Treasurer's office said there was no interest from investors in purchasing the notes. However, that was two months ago and that official may not have been fully informed on efforts by stem cell chairman Robert Klein to peddle the notes. He seems to have taken on the sale as a personal project.

A sale of the notes in amounts that would not fully fund the first year of all the authorized grants raises interesting questions about which institutions would receive cash and in what amounts. Presumably that would be a decision that would be made by the stem cell Oversight Committee, which does not meet again until February. A politically astute grant recipient might promptly begin discreet lobbying of Oversight Committee members to assure that its programs receive favorable consideration.

A Korean Lesson: 'Money Breeds Corruption'

The California stem cell agency needs to start asking more questions about the Korean scandal and how it may relate to stem cell research in the Golden State, The Sacramento Bee said today in an editorial.

The Bee said CIRM can learn from the Hwang affair but only if the agency takes "the time to publicly grapple with this scandal. So far, they have acted as if Hwang is a distant aberration whose fabrications don't affect them. Nothing could be further from the truth."

The editorial continued:

"While California's institute can do only so much to combat scientific fraud - the responsibility lies largely in the hands of peer-reviewed journals - it can set standards for obtaining eggs and other biological material, and ensure those rules are enforced. The institute's medical standards working group is now preparing such regulations. Yet at their last meeting, on Dec. 1, the committee's members went out of their way to avoid any discussion of Hwang's mounting troubles."

In a separate opinion piece, Associate Editor Stu Leavenworth wrote that it is easy to learn the wrong lessons from Korea.

It is, he said, "laughable to hear people insinuate that this debacle could have been avoided if American researchers, and not the South Koreans, were leading the way.

"The annals of U.S. science are filled with researchers who faked findings, exploited human test subjects and enriched themselves while extolling their supposed ethics. Indeed, it is interesting that Hwang's fraud was exposed not because of scrutiny from U.S. researchers, but because his colleagues in South Korea had the courage to go public with questions about their 'supreme scientist.'"

He continued,

"The only lesson is an old one: Money breeds corruption. Rightly or wrongly, embryonic stem cell research is seen as the next big rainmaker in the biomedical field. With so much money riding on the outcome, some people are going to lie, cheat and steal.

"To combat such fraud, editors of science journals - and those of us in the media - need to be much more skeptical than we were in this case."

California Stem Cell Director Stresses Speed

One of the members of the Oversight Committee of the California stem cell agency spoke of the need for "urgency" in finding stem cell therapies in an interview with a newspaper printed today.

The quest for speed is one of the problems at the heart of the Korean stem cell scandal, according to some scientists.

Joan Samuelson of Healdsburg, CA, an attorney and president of the Parkinson's Action Network, is the committee member who did a Q&A with the Santa Rosa Press-Democrat. Given the nature of such Q&As, it is likely that she actually made her comments anywhere to a few days to a few weeks prior to their publication, probably at a time when the scandal was not as hot. The topic of Korea did not even come up in her printed remarks.

Nonetheless, one of the refrains heard from the patient advocates is the crying need for cures. Some, such as Samuelson, are living with diseases that could be alleviated through the results of stem cell research.

Here are a couple of excerpts from the interview:

"Prop. 71 seeks something that may be a first in biomedical history: not just research advances, but actual treatments and cures resulting from the investment of funds, and in a tight time frame. The National Institutes of Health, for example, spends about $30 billion each year in federal tax dollars to fund research, but requires no particular results.

"My 15 years of watching this process causes me to side with the scientists who believe that if every step is treated with great urgency, sharing of information, collaboration in approaches and adequate funding, that will start translating into the first treatments far sooner than they will if this process is left to chance."

"Several forces delay finding cures. For example, you might not get a cure for decades because researchers don't stick to the problem. They move on to something else, because they lose interest, because it's too hard, because there's no funding.

"But this won't happen at the institute because 10 of us wake up every morning saying, 'Please, God, let this succeed.' My vision is that the institute will be available to fund any piece of remaining research needed. We're going to have to work with the whole world."

The reference to "10 of us" is to the number of patient advocates on the board.

CIRM Scientific Conference Expenses Disclosed

The California stem cell agency's international scientific conference last October cost $128,489, coming in nearly $87,000 under budget.

The event drew a fair amount of news media attention (see "Everything" and "Clues" items on this blog) and was praised by editorially by at least one newspaper as one of the wisest expenditures CIRM has made. That said, the agency was a bit balky at releasing the budget figures.

The largest single expenditure was $48,643 for rooms, facilities and equipment at the PARC 55 Renaissance Hotel in San Francisco. Rooms were discounted 30 percent for the 32 persons that the agency picked up expenses for. CIRM paid $45,200 to Mosaic Event Management to run the event. Travel expenses for speakers and others ran an estimated $20,000. Another estimated $9,000 is slated to go to science writer Kelly LaMarco, who is preparing an executive report of the meeting.

The event generated $23,450 in registration and other fees.

The expenses do not include a reception for attendees that was hosted at the St. Francisco Hotel by the California Healthcare Institute, a biomedical industry group.

Why Do Scientists Cheat?

"If you're not in first place, you're no place," says one bioethicist in an article in the Christian Science Monitor about what it calls "a year of research ethics challenges."

The springboard for the piece by reporter Peter Spotts is the Korean affair. But Spott recounted scientific scandals at the Veterans Administration, MIT and the University of Vermont.

He also dealt with dubious dealings at NIH.

"In a survey of NIH-funded scientists, released in June, only 1.5 percent of 3,000-plus respondents acknowledged having falsified or plagiarized information. But 15.5 percent admitted to altering their research approach under pressure from funding sources, and 12.5 percent admitted to looking the other way when colleagues used flawed data."

The comment about "first place" came from Thomas Murray, president of the Hastings Center, a bioethics institute in New York state. He noted that scientists have the usual human failings but work in an intense environment where only the best ideas rise to the top. He did not say "perceived" best ideas, but he should have.

Christmas Comes Early for Sen. Ortiz

The Korean stem cell scandal is a bit of political gift to California state Sen. Deborah Ortiz.

While it certainly was not something she was hoping for, the hoo-ha surrounding Hwang Woo-suk has created an atmosphere that will aid Ortiz' efforts to tighten oversight of the California stem cell agency, protect egg donors and ensure that California reaps the benefits of its $6 billion research investment.

Ortiz, a Sacramento Democrat who is the most influential California legislator on stem cell matters, authored legislation earlier this year to protect egg donors. Public awareness of the bill was minimal, and it was vetoed, with little notice, by the governor.

Ortiz plans to re-introduce the measure come January. It will have a much more favorable environment given the heightened awareness created by the Korean cash-for-eggs affair, which involved egg donations from junior researchers as well. That is considered improper by some.

Her proposed constitutional amendment, SCA13, will also gain support as a result of the Korean scandal. The measure would increase state oversight of the agency and is intended to provide more benefits to California from research commissioned by CIRM. It requires a two-third vote of both houses and voter approval. But the proposal has key Republican support, which should help ease its passage in the legislature.

Ortiz is undoubtedly going to exploit – directly or indirectly -- what one observer has called the "flabbergasting" disclosures coming from Korea to bolster support for the proposal, which has been opposed by CIRM and its allies.

Term limits will force Ortiz out of the legislature at the end of 2006 so she has a limited time to accomplish her legislative objectives. She is reportedly eyeing a statewide office and also needs a solid record to campaign on.

Earlier this year – prior to the Hwang affair – Ortiz indicated that stem cell matters were at the top of her agenda.

"I have about a year left in the Legislature, but this will probably be my No. 1 priority.  The stakes are too important if we don’t meet the intent of the initiative, and if we don’t make good on the promises we made to the voters," she said during a hearing on intellectual property and CIRM.

Look for a major push by Ortiz after the turn of the year that will involve PR, op-ed pieces, public appearances, support-building among stem groups and more.

California Stem Cell Leaders Speak to Korean Scandal

A number of California stem cell researchers discussed the Korean stem cell scandal in a piece by reporter Bruce Lieberman in the San Diego Union-Tribune, including two members of the Oversight Committee of the California stem cell agency. Here are some excerpts from the article:

"'It's a black eye on the whole world of science,' Richard Murphy, president of the Salk Institute in La Jolla (and CIRM director), said. 'Exciting areas of research are always competitive . . . but healthy competition never justifies sloppy research, cutting corners or dishonest behavior.'"

"'We would have figured out very quickly that there was some problem here. . . . And the truth would have come out much sooner had we been in a position like we normally are – to be able to jump in and work with complete freedom,' said John C. Reed, president of the Burnham Institute in La Jolla(also a CIRM director). 'It's very important that we have laboratories throughout the country and around the world to . . . verify whether observations made by one group are reproducible by another.'"

"Dr. Evan Snyder, head of stem cell research at the Burnham Institute in La Jolla, said the embarrassing South Korea episode shows how science's built-in system of checks and balances can root out misconduct.
"'This was an example of the scientific community doing what it does routinely, which is police itself,' Snyder said.

The story also quoted Hallye Jordan, a spokeswoman for State Sen. Deborah Ortiz, the lead author of a proposed ballot measure to tighten controls on the California stem cell agency.

"'This whole unfortunate episode has pointed to the need for good governmental oversight of this important research," Jordan said last week. 'We want to maintain the public's confidence in stem cell research, and the best way to do that is through accountability and openness.'"

Korean Markets Warn Off Shy Stem Cell Investors

Those timid souls known as venture capitalists are not likely to be encouraged by the events in Korea, and that is likely to reflect poorly on the stem cell investment climate in California, at least for the short term.

Some, however, might argue that it is a buying opportunity – prices are down because of temporary market indigestion in swallowing the bad news out of Asia.

In the past few days the news has not been good for those holding Korean biotechnology investments. According to Reuters, prices in Korean biotech stocks "plunged" on Friday, one company by 15 percent.

The market reaction is another reason why private capital is not interested in funding the type of research that the California stem cell agency would if it were not snarled in a lawsuit.

Korean News Fuels Fire Against CIRM

As the negative news about stem cell research rolled in from across the Pacific, the Los Angeles Daily News (circulation 195,000) carried a hostile article about the California stem cell agency written by one of the minions of a "free market think tank" in Sacramento.

The opinion piece was authored by K. Lloyd Billingsley, editorial director of the Pacific Research Institute, which calls itself a "free market think tank." The facts of the piece are all familiar to followers of the agency.

However, he quoted Wesley J. Smith of the Discovery Institute, another similar organization, as arguing:

"Voters might be disposed to undoing Prop. 71" when they believe in alternatives "and when the problems of Prop. 71 permeate the public consciousness. One year after the vote, that is beginning to happen."

The views of such folks as Billingsley and Smith find fertile ground when the stem cell turf is disturbed by the Korean uproar. Two months ago such views would have had much less impact than they do now. Beyond that, the references to the voters disposition makes it clear that the opponents of Prop. 71 are looking at a ballot measure involving the agency. That means CIRM and its friends should be rallying anybody who could be considered their allies. The best bet for the agency is to keep a measure off the ballot, whether it is SCA13 or an initiative backed by well-financed fundamentalist forces.

Bioethics Blog Weighs Hwang Damage

In our earlier item on the implications of Hwang affair, we should have included the comments from the Editors Blog of the American Journal of Bioethics, which has spent a fair amount of time on the issue.

In a posting from today (Friday) on the site, blog.bioethics.net, they wrote:

"So what will happen as the story becomes a huge huge media story tomorrow is anyone's guess. The key questions though seem likely to involve a billion versions of: 'Will ethical lapses in this lab damage stem cell research elsewhere?'
Answer: yup. And no amount of late-in-the-day standards creation will change that. People are going to ask whether the mechanisms whereby stem cell money is doled out have to be made much more rigorous. And yet again, the U.S. government will be zero help, since our rule for how to fund stem cell research is based on the altogether stupid idea that some tiny collection of embryonic stem cells in Wisconsin are ok in terms of ethics and money, but anything made after August 9, 2001 is evil and not to be funded."

The Half Empty Implications of the Hwang Affair

Is the Hwang Woo Suk affair the WMD issue of stem cell research? Does it fuel the foes of embryonic stem cell work? How will it affect the California stem cell agency?

Just some of the questions being addressed as the affair has blossomed from cash-for-eggs to possible outright fraud.

In California, as elsewhere, the Korean stem cell scandal is something of a half-empty, half-full matter. Supporters say it demonstrates the need for solid research with top notch oversight and well thought out rules. On the other hand, foes certainly will use it to argue that stem cell researchers cannot be trusted. But there is little doubt that the tangled controversy will create confusion and uncertainty on the part of the public about stem cell research, which has recently enjoyed generally good press.

For CIRM it arguably creates an unfavorable climate for the sale of tens of millions of dollars in notes sorely needed to finance the agency. However, a case certainly will be made that now is the time to get behind CIRM and its high standards.

Zach Hall, president of CIRM, was somewhat circumspect in a statement:

“The withdrawal of the results by Drs. Schatten, Hwang and the South Korean group is a serious setback for stem cell research in the area of somatic cell nuclear transfer. Such incidents have happened before in science and are always unfortunate both for the field and for the scientists involved. The good news is that many talented researchers will continue their work on nuclear transfer and I am confident that the field will recover and quickly move ahead.”

The Center for Policy and Genetics in Oakland, a longtime CIRM critic, said on its web site:

"Given that investigative journalists, not scientists, uncovered the falsified data, how can the senior US and British scientists who asked the media to refrain from questioning the 'validity of the experiments' justify their request?"

The center continued:

"Now that it is clear that the voluntary guidelines for embryonic stem cell research recommended by lead scientific bodies in the US are inadequate, how can we move to put in place enforceable regulations that will protect women and allow legitimate embryonic stem cell research to advance?"

Reporter Gina Kolata of the New York Times touched on one of the deeper implications of the affair. She quoted Laurie Zoloth, director of the Center for Bioethics, Science and Society at Northwestern University, as saying it "raises questions about whether the science is good."

"'Good as in true and real and morally worthy of our funding,' she explained. 'That is so most especially in this twilight sort of terrain with a lot of open questions that people disagree about. 'Is this our version of WMD.?' Dr. Zoloth said."

Writing in the Wall Street Journal, reporters Antonio Regalado and Gordon Fairclough said:

"Regardless of the outcome, the case once again underscores the limitations of top scientific journals in verifying the results of the research they publish. Journals typically recruit independent reviewers to review papers. But such reviews don't involve actually repeating the experiments, which makes intentional fraud difficult to detect."

John Rennie, editor in chief of Scientific American, wrote online:

"How much of a colossal black eye will this scandal give to embryonic stem cell work in general? I commented on that point previously, back when it looked like Hwang's headaches all centered on the research ethics. But outright fraud carries this to a whole new level. Frankly, I've been surprised that some of the usually vociferous opponents of embryonic stem cell research haven't been making more of a fuss about the Hwang affair all along. I kept waiting to hear them argue that the ethical laxity of the Korean lab only proved that the moral of judgment of stem cell researchers couldn't be trusted--that no matter what promises the scientists made to uphold human dignity in their work, they would surely start committing atrocities once they were allowed to operate freely. (My hunch is that the clear willingness of so many in the stem cell community to push for strong codes of scientific ethics has blunted this attack so far.) Something tells me that those kinds of criticisms will become much more common shortly."

One industry perspective came in a piece by Barbara Demick and Karen Kaplan in the Los Angeles Angeles Times. They quoted Michael West, president and chief scientific officer of Advanced Cell Technology Inc. in Worcester, Mass., as saying his company "would redouble its research efforts now that there might be a fresh opportunity to be the first to create individualized embryonic stem cells."

"This is a chance for the U.S. to recapture the lead in this field," he was quoted as saying.

As for the opponents, Kolata talked to two, including Nigel Cameron, president of the Institute on Biotechnology and the Human Future at the Illinois Institute of Technology.

"'Where's the beef? Where are those cures? Why is it that there is no private money going into this research? The business community values it at zero,'" Kolata quoted Cameron as saying.

She also quoted Richard Doerflinger, deputy director of anti-abortion activities at the United States Conference of Catholic Bishops, as saying,

"'In one sense, this puts us back to where we were before May of 2005, when there still was some uncertainty about whether this would work at all. In another sense it does illustrate in my mind how hype and ambition have gotten ahead of the science.'

"'How am I going to exploit it?' he said. 'You don't have to. It's just speaking for itself.'"

Coming Up

Later today we will carry a report and assessment on how bad the news is out of Korea for stem cell research. What it means for the credibility of the work and more.

Korean Mess Bad News for Funding of California Stem Cell Agency

The tangled Korea-Egg scandal became more convoluted today with an adamant denial by Hwang Woo-suk that he falsified stem cell research findings.

His statement came after news outlets worldwide published reports quoting a co-researcher as saying that Hwang had essentially confessed.

That did not appear to be the case according to reporter Kwang-Tae Kim of The Associated Press.

"South Korean researcher Hwang Woo-suk on Friday stood by his purported breakthroughs in stem cell research despite accusations he falsified key evidence, saying his work would be authenticated after tests performed within days," The AP said.

Hwang said he was "shocked" by his co-researcher's statement that work was faked.

Bloomberg.com reported the Korean stock market declined as a result of the flap. Bloomberg wrote:

"'I apologize for creating this uproar both in and out of Korea,' Hwang told reporters at a briefing in Seoul today. 'The fact remains that our research team was successful in creating stem cells from patients' skin cells. Still, there were mistakes made, human errors, in taking photographs and in the preservation of the stem cells.' Hwang said he will seek agreement from his 24 coauthors to retract the study from Science."

Reuters reported:

"'Our six research members made 11 stem cells and all confirmed this,' Hwang said at the packed briefing in a lecture hall. 'We six researchers have no doubt.'" Hwang said the cells had been badly contaminated by a fungus and he planned to ask prosecutors to investigate his suspicion that they may have been tampered with or replaced."
Reuters continued:
"Hwang said he was retracting the paper from Science because of the uproar, even though he did not doubt his findings. He said a follow-up paper had been submitted to another journal and that would restore faith in his team."

Newspaper readers all across the country this morning will see stories about Hwang's alleged confession. If they hear anything on the radio or TV it will lead with his denial. The Internet will have it all. Major confusion will result until this is all sorted out, but meanwhile stem cell research will take a hefty PR hit. And that is not good for the folks trying to sell tens of million of dollars in notes to finance the California stem cell agency.

Does the Korea-Egg Affair Give California More Stem Cell Clout?

The editor in chief of Scientific American, John Rennie, has put together a review of the implications of the Korea-egg scandal, which he described as "flabbergasting."

Writing on his blog, Rennie said:

"In six months, this work went from being one of the most celebrated accomplishments of recent biotechnology--probably a strong contender for future Nobel consideration--to what may become a legendary scientific fraud akin to the Piltdown man."

Rennie addressed a number of questions, one of which was "how does all this affect the international competition for stem cell dominance?" Rennie's answer:

"If Hwang's work is illusory, though, the center of power would seem to have swung back over to the U.S. -- that is to say, California."

Rennie's final paragraph:

"There's an old wry observation that if you look back at disastrously bad decisions made throughout history, you could probably find someone connected to each who would have said, 'Well, it seemed like a good idea at the time.' But I can't see how anyone in the Hwang lab could have ever even thought that."

Korea Herald: Hwang Faked Stem Cell Research

The Korea Herald reports that "Hwang Woo-suk fabricated his stem cell research published in journal Science this year and asked the journal to retract his paper."

The newspaper said that Roh Sung-il, who co-authored a Science paper with Hwang, "admitted there remain no embryonic stem cells which his team claimed to create through cloning."

The newspaper continued:

"Lee Wang-jae, a senior SNU (Seoul National University) official, confirmed that the research was fake.

"'Hwang's research team admitted that there were no embryonic stem cells which it claimed had created,' said Lee who was tapped to lead a SNU committee to investigate his research. 'Today is the most shameful day for Korea's science community.'"

Should Women Be Allowed to Sell Their Eggs?

Some folks who take a jaundiced view of embryonic stem cell research are calling the Korea-egg affair the "first international scandal of the biotech century" and say California better watch its Ps and Qs.

Nigel M. de S. Cameron and M.L. Tina Stevens laid out their concerns in an opinion piece this morning in the San Francisco Chronicle. Cameron is chair of the Center for Bioethics and Culture in Oakland. Stevens teaches history at San Francisco State University.

They wrote:

"California needs to do some soul-searching. Some of us said all along that the only way cloning researchers would ever get anything near the number of eggs they needed would be through unethical channels. We thought they would go to poor women in poor countries, which is one reason so much of the developing world supported the U.N. global cloning ban. California should ban payments for egg donation for embryonic stem cell/embryonic cloning research. Stiff penalties for violations should be enforced. Moreover, it should proceed only after serious, independent, medical study aimed at addressing unanswered concerns over the long-term effects of hormones and egg extraction takes place. Only then can the state offer a meaningful and fully 'informed consent.'"

A couple of thoughts: CIRM currently bars compensation for egg donations. Cameron and Stevens apparently want to take this a step further and bar payments to cover expenses. Their piece also repeatedly uses the expression "human cloning" without noting that is forbidden by Prop. 71, leaving the reader to infer wrongly that the California stem cell agency is engaged in such activities.

The Korean egg business does lead to the question of whether women should be allowed to do whatever they want with their bodies including production of eggs. An international flat prohibition against payments for eggs also is certain to be violated, given the stakes involved in stem cell research. If payments are legal and regulated, presumably they can be policed appropriately with better oversight of how donors are treated.

That said, we are still withholding judgment on the question of cash for eggs. Let us know what you think about the matter. Should California allow women to be paid for providing their eggs for stem cell research? You can post your comments by clicking on the word "comments" at the end of this item. It allows you to post anonymously if that is your wish.

The Painful and Rocky California Stem Cell Experience

"A rocky year," "defensive," "a painful process" – some of the descriptions of the last year for the California stem cell agency.

They were contained in a front page story Saturday by reporter Terri Somers of the San Diego Union-Tribune, which circulates in one of the world's hottest hotbeds of stem cell research.

Somers is a biotech business reporter who has covered the agency since its inception. Here is how her piece began:

"In the 13 months since California voters approved spending $3 billion of their tax dollars on stem cell research, not a dime has gone to scientists.

"There have been 54 public meetings surrounding the start-up of the state's new Institute for Regenerative Medicine. Yet two of its most important policies and plans have not been established: a plan for how to handle ownership of discoveries resulting from institute-funded research and a scientific strategic plan, the cornerstone of the institute."

Here are some of the highlights of Somers' story:

"It's been a rocky year," said Dr. Leon Thal, a UCSD neuroscientist on the oversight committee. "I don't think some of us knew it would be quite as political as it has been."

"The (institute), for some reason, is coming from the position of being defensive all the time," said Dr. Jeannie Fontana, an advocate for patients with Lou Gehrig's disease who serves as an alternate member on the oversight committee."

"It's been a painful process at times," Fontana said(in a later quote). She said the oversight committee is much more complicated than other boards on which she serves and doesn't work as efficiently."

"I didn't realize how much administrative work had to be done in just setting up (the institute)," said Zach Hall, a neurobiologist serving as its president."

Our comments: Hall is a skilled, veteran and respected administrator as well as a respected scientist. As far as we can tell, he has a candid and gimlet-eyed view of agency's status.

But, speaking from the perspective of a person who has been involved in more than one start-up and studied them for years, we can say that few persons understand the difficulties involved in a creating a genuinely new enterprise of even the smallest size, unless they have been directly involved.

On another somewhat personal note, the start-up nature of CIRM was one of the motivations for creation of this blog. Going overnight from scratch to $300 million a year in a field fraught with complexities, cutting edge science, religion and politics and more offers, to put it mildly, a fertile field.

As for Somers' article and a similar overview, also on Saturday, by Andrew Pollack of the New York Times, they are the type of pieces that help shape public perspective on CIRM, for better or worse.

Searching for Stem Cell News in All The Wrong Places

Earlier we reported that we could not find online two stories by reporter Terri Somers of the San Diego Union-Tribune, a biotech business reporter who covers the agency regularly.

We saw them in a print edition of the paper during a visit to the city, but could not find them using a Google search or a direct search of the site. But two readers of the California Stem Cell Report, Jerry Ingle of Encinitas and another who must remain nameless, pointed us to their electronic location.

The technique, for those who want to use it, is to go the www.signonsandiego.com and click on today's paper and then look for the day that you are seeking. Then it will list all the stories prepared by the paper's reporters that day by various categories.

The lessons for us? 1. Never assume, which is a lesson we seem to need to learn more than once. 2. Google searches are not omnipotent. 3. Search engines on particular sites are also not omnipotent, including The Sacramento Bee and others as well as the San Diego site.

All of this brings us to our dear readers. If you folks out there see something of interest or something that needs to be corrected, please let us know. And if you want to make a comment, you can simply click on the comment line at the bottom of this item. We hope to hear from you often.

Here are links to Somers' Thursday story and her Saturday piece, which is the subject of a posting above.

Zach Hall Critiques Sacramento Bee Editorial

Zach Hall, president of the California stem cell agency, has responded to a Sacramento Bee editorial involving human eggs and cash.

In a piece printed in the opinion section of The Bee on Sunday, Hall said The Bee editorial Nov. 25 "gives the impression" that CIRM "has only recently examined these issues, (when) in fact we have been working on them long before the recent controversy in South Korea."

He noted that Prop. 71 prohibits "compensation" for eggs and requires "informed consent" for donations. Hall adds that egg donation has been the subject of considerable discussion at CIRM meetings and will be the topic of an upcoming session.

"As a final point," he wrote, "I am perplexed that The Bee cites figures for the efficiency of establishing cell lines that The Bee acknowledges to be out of date. The most recent work (Science, May 2005) shows that, on average, only 16 eggs (the approximate number obtained from a single donor) are required to develop a stem cell line, a figure that is 15-fold fewer than the number cited in the editorial. With continued advances, the number of eggs required will continue to fall and, in time, other methods, not requiring egg donation, may become practicable."