With more than 3.0 million page views and more than 5,000 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency. David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.
Tuesday, December 13, 2005
Should Women Be Allowed to Sell Their Eggs?
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.
Monday, December 12, 2005
The Painful and Rocky California Stem Cell Experience
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
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.
Sunday, December 11, 2005
Zach Hall Critiques Sacramento Bee Editorial
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."
Saturday, December 10, 2005
NY Times Looks at Beleaguered CIRM
His remarks were contained in a piece today by reporter Andrew Pollack of the New York Times, whose article began like this:
"After nearly an entire morning of sometimes heated debate the other day, the board overseeing California's $3 billion stem cell research institute took action. It asked the organization's president to draw up a plan for how to draw up a strategic plan.
"That is the way it has been going lately for the state's closely watched foray into the frontiers of medical science. More than a year after 59 percent of Californians approved an ambitious program to harness human embryonic stem cells to treat diseases, not a single dollar has yet been spent on research."
Pollack noted the litigation, legislative and public pressure as well bureaucratic minutiae beleaguering the agency.
"'I liken it to the Iraq thinking - we won the war and didn't know what to do afterward,' said Paul Berg, a Nobel laureate from Stanford University who fills in on the institute's board when Stanford's medical school dean cannot attend," Pollack wrote.
His piece was something of a "situationer" on CIRM, bringing Times readers up-to-date. The newspaper has not carried much on the agency. Followers of CIRM, however, will find a fair amount of familiar ground in the piece. The article was also distributed on the Times' news service and has already appeared in one other paper in Milwaukee. It is likely be printed elsewhere.
Reporter Terri Somers of the San Diego Union-Tribune also put together a situationer for her paper, one that ran on the front page today. However, it is not available online as far as we can tell. We saw it because we were in San Diego for a visit. We will bring you excerpts from it later.
Friday, December 09, 2005
Spending on Litigation Seems to Please Stem Cell Foes
Steve Ertelt, editor of LifeNews.com, wrote today:
"Taxpayer and pro-life groups that oppose Prop. 71 have been successful in holding off grants for embryonic stem cell research and human cloning because of their lawsuits against the measure. They have also forced the stem cell panel to spend a quarter of its money on legal bills."Ertelt described the agency's proposed research as "grisly."
In recent months, foes of the agency have contended their opposition is based on good government issues – not religion. But those statements seem to be something of an exercise in dissembling -- to be generous -- based on the comments of Ertelt and others. Earlier this week we noted one of their attorney's assertions about the creation of subhuman beings.
Ertelt's piece also seems to borrow some information, without attribution, from an article by reporter Terri Somers of the San Diego Union-Tribune. She wrote two stories this week out of the meeting Tuesday of the Oversight Committee in Duarte.
We previously linked to her first story on Wednesday. Her second story appeared in the actual newspaper but did not appear online as far as we can determine. We ran across the article in the printed version of the paper.
She reported that CIRM has a $240,000 bill from the state Department of Justice in addition to the $772,000 it is paying its private lawyers. That pushes the agency's legal costs to more than $1 million in less than a year or about $2,800 a day, by our calculations. Not all of that is tied to the litigation, but it remains a rather substantial sum.
Somers also quoted Dana Cody of the Life Legal Defense Fund as saying, "This is a taxpayer issue and Bob Klein managing to have access to taxpayer money that he isn't entitled to, no matter how Bob Klein spins it."
Ertelt appears to have picked up that quote from Somers without noting that it came from her piece. Of course, it could have come to Ertelt directly from Cody as well.
Cody's concern about tax funds notwithstanding, it is abundantly clear that the Life Legal Defense Fund would not be suing CIRM if it did not plan to fund the "grisly" embryonic stem cell research.
Thursday, December 08, 2005
Klein Discusses Korea Trip and Other Matters
He estimated the lawsuits could take as much as 15 months to go through the appeals process. He said the journey to Asia was a "general trip to look at the full range of research in Korea and to have talks with the Korean government on their future commitments, which they have expanded substantially." He did not mention the name of Woo Suk Hwang.
He also said the $1.1 billion royalty figures supplied by a study commissioned by the Prop. 71 campaign have been taken out of context.
The hour-long interview was conducted by Capitol Weekly reporter Malcolm Maclachlan.
Depositions Could Be Illuminating
In an unsigned editorial, the newspaper also says the depositions in the case should be illuminating.
"One important question is how Robert Klein II, the author of Prop. 71, devised the stem cell institute, and what promises he made in doing so. Did he, for instance, promise universities and organizations seats on the oversight board if they endorsed Prop. 71?"
It also notes that the plaintiffs are on a "crusade" to stop all embryonic stem cell research.
Wednesday, December 07, 2005
U. of Pittsburgh and the Schatten/Hwang Affair
The latest reports from South Korea say that the University of Pittsburgh is paying to help South Korean researchers secure permanent resident status. Obviously, employers assist with immigration matters regularly, but the Koreans suspect skulduggery.
Here is a report from Digital Chosun in South Korea:
The Schatten/Hwang affair has implications for the conduct of stem cell research in California. One of which is that maximum disclosure of all significant financial interests is needed, given the built-in conflicts with the stem cell agency. Sunshine is the best preventative, as we have noted earlier."Fears mounted on Wednesday that key cloning technology developed by stem cell pioneer Prof. Hwang Woo-suk and his research team could be leaked abroad after it emerged that two former team members have applied for permanent residence in the U.S. The two are party to sensitive inside knowledge on core stem cell technology.
"A source in Hwang's team said the two were seconded to the University of Pittsburgh last year and now applied for residence in the U.S.
"One of them is said to be Park Eul-soon, who made headlines last week by dropping out of sight and severing contact with the Seoul National University team. She is party to a newly developed technique for the removal of an egg's nucleus for cloning and has played a key role in Pittsburgh Prof. Gerald Schatten's cloning of monkey embryos. The other former team member has inside knowledge of embryonic stem cell cultivation technology."
We have queried the University of Pittsburgh concerning its role and will carry its response when we receive it.
Tiny Turnout at Stem Cell Agency Meetings
Perhaps our reaction is that of one who believes, however naively, that what public agencies do is important, especially one that is as unique, new and important as CIRM.
The number of persons in the audience in Duarte Tuesday ranged from 10 to 20 persons and probably included some media. The Oversight Committee itself, without including CIRM staff, outnumbered the public.
We also attended an Oversight meeting in September in Sacramento that had a rather sparse crowd. One of the regular attendees at all the meetings has told us that the lean turnout is pretty regular.
From our own experience in covering state agencies, we can tell you that huge crowds rarely show up for any state agency meetings. But usually a goodly number of representatives from businesses, nonprofits or other institutions affected by the agency appear. So far, that does not appear to be the case for CIRM.
As for our own dismal attendance record at the Oversight Committee meetings, we would like to attend more but we live fulltime on a sailboat in Mexico, returning by air to the Old Country only for intermittent visits. It is then that we take in meetings and chat with some of the players involved in California stem cell issues. Meantime, we stay in contact with stem cell matters via the Web and email.
Reviewing Today's Coverage of the Stem Cell Agency
Missing were reports from the Los Angeles Times and the New York Times, both of which covered the stem cell meeting Tuesday in Duarte. However, we would expect to see pieces from them, perhaps on Thursday.
The Oversight Committee meeting ended late in the day, making it difficult to file a story for the next day's papers. The reporters involved may well be working on a different type of piece than the usual daily report on what was relatively routine action – at least in terms of conventional news values.
Which brings us to one of the reasons for the existence of the blog. Conventional news values put a severe limit on the amount and depth of information available in newspapers concerning the agency. Newspapers emphasize high profile events and conflicts. When matters are relatively routine, attention wanes. They have little interest in the type of details that are important to those with a deep interest in a subject. The rather sparse coverage of intellectual property issues, over the last few months, involving the stem agency is one example. IP is technical, complex and marginally understood by editors, many of whom view their own intellectual product (the daily newspaper) as having little lasting value. Once it is a day old, it is fish wrap material.
One of our goals is to carry more information and analysis on issues of concern to the California stem cell community than is available through the mainstream media, to use an expression which has already become an Internet cliché. Much of it has little conventional news value so you are not likely to find it in the press. If you would like to weigh in our performance or have suggestions for additional coverage, just click on the "comments" link at the end of this posting. You can even do it anonymously.
But back to today's coverage. Reporter Terri Somers of the San Diego Union Tribune wrote a piece on the IP action by the agency. Her story began:
"Scientists who make a patentable discovery with grant money from California's fledgling stem cell institute will be able to retain ownership of that discovery under an interim policy approved yesterday by the committee overseeing the institute."
Reporter Carl Hall of the San Francisco Chronicle focused on developments in the lawsuit against CIRM.
He wrote that foes of the agency "face tight deadlines for gathering evidence, which may include depositions from the 29 members of the stem cell institute's governing board, known as the Independent Citizens Oversight Committee, as well as outside participants in advisory working groups."
"'Our goal is to win,' said Dana Cody, executive director of the Life Legal Defense Foundation in Sacramento, one of the attorneys working on the case.We should note that the stem cell agency is a bigger story for San Francisco and San Diego than other areas. San Francisco is the home to the agency and has the largest concentration of biotech firms in the state. San Diego comes in a close second. Both cities have substantial stem cell research communities as well.
"She and her allies clearly have no plans to drop the litigation even if they lose at trial. Barring some 'glaring factual discovery,' Cody said, 'we will be going on to the appeals court and then to the Supreme Court if we have to,'" according to Hall's story.
Tuesday, December 06, 2005
Coming Up
For those of you far removed from Southern California, Duarte is a bit of hard-scrabble community east of downtown Los Angeles. The City of Hope, with its beautiful gardens, is not too far from such establishments as "Miss Kitty's Topless Gentlemen's Club."
Foxes, Chickens and Stem Cells
John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights of Santa Monica, targeted a proposal that would give nonprofit institutions ownership rights on discoveries.
"Asking the grantees to do the right thing after giving away the farm is like asking the fox to cough up the chickens after giving him the key to the hen house," Simpson told the Oversight Committee. (The full statement from the Foundation can be found here.
Jesse Reynolds of the Center for Genetics and Society also asked the board to ensure that stem therapies would be truly available to all Californians.
The panel approved the interim rules after modifying them slightly from the draft version (see "Not Like to Satisfy."). Inserted was a preference for non-exclusive licensing. Removed was a reference to a "tax" on royalties that might be imposed by the state. Instead the language was changed to indicate that the state might want to share in royalties in the future.
Some Oversight Committee members objected to language giving preference to therapies for underserved groups. Joan Samuelson, a committee member and president of the Parkinson's Action Network, said it could delay development of therapies for other groups.
But Marcy Feit, president of ValleyCare Health Systems, said removal of the language would "kill funding" for the stem cell agency.
Stem Cell Trial Date Set, Legal Coffers Replenished
Judge Bonnie Lewman Sabraw set the date today, according to stem cell agency officials, fulfilling her promise to expedite proceedings in the lawsuits that have blocked funding of $3 billion in stem research grants, approved by California voters 13 months ago.
The lawsuits were filed by anti-tax groups and another group that was a key player in the Schiavo case. The stem cell foes contend the agency is unconstitutional although it was created by voters in a constitutional procedure. (See "Showdown in Apricot City.")
The judge told lawyers to return Dec. 13 with plans for discovery of evidence. Completion of discovery was scheduled for Jan. 3.
At a meeting of the CIRM Oversight Committee in Duarte, stem cell chairman Robert Klein expressed pleasure with the legal schedule. He has been trying to sell bond anticipation notes to provide interim financing for the agency. A quick trial and decision will help eliminate investor uncertainty about the financial instruments.
Following announcement of the news at today's meeting of the CIRM Oversight Committee, the panel approved an additional $252,000 for outside legal help, most of which will go for contesting the challenge to the existence of the agency.
Claire Pomeroy, an Oversight Committee member and dean of the UC Davis School of Medicine, said the lawsuit has forced the agency to divert funds from possible research, indicating that voters would be irate at impact of the tactics of the stem cell foes.
Nonetheless, we suspect the agency's opponents are delighted that they are stalling the agency and preventing it from spending money on research. After all, one earlier version of the litigation, filed by David Llewellyn, a Citrus Heights, Ca., attorney, alleged that loopholes exist in the Prop. 71 that would permit the funding of "test tube babies, or even adult human beings, for body parts, companionship or a permanent worker class of subhuman beings (a la Aldous Huxley's Brave New World)” despite the measure's ban on human reproductive cloning. The ludicrous assertion was clearly aimed at stirring up irrational fears among the constituencies that support the foes of CIRM. (see the Feb. 23 item called "Illegal" on this blog.)
A quick and favorable trial decision certainly will help the agency to peddle its notes, but the case is expected to be appealed by whichever side loses. One estimate predicts that the legal matters will not be completely settled until 2007.
The official name of the Apricot City, by the way, is Hayward, which is an Alameda County community once better known for its fine fruit than stem cell shenanigans.
Sunday, December 04, 2005
IP Proposals Not Likely to Satisfy
At its meeting Tuesday in Duarte, the agency is scheduled to consider basic, interim IP regulations for its training grant programs, which are aimed at training more stem cell researchers and are not expected to result in discoveries that need IP protection. But just in case, the Oversight Committee is moving forward with some regulations.
On the agenda is a simple document about "concepts" for IP policies on training grants. Here it is in its entirety.
"Ownership: CIRM grantees will own CIRM-funded discoveries.
"Data/Biomedical Materials Sharing: CIRM strongly supports a broad sharing policy. CIRM will expect grantees to share data and biomedical materials widely, and beyond current practices. CIRM will 'push the envelope of current practice toward much more open' sharing.
"Research Exemption: CIRM will create a research exemption to allow the use of patented CIRM-funded discoveries for research purposes.
"Licensing: CIRM will encourage the commercialization of CIRM-funded discoveries. In licensing activities, CIRM will require that preference be given to companies with plans for access to resultant therapies for underserved patient populations. It is anticipated that any resultant royalties from CIRM-funded discoveries may be subject to a 'tax' to benefit the state of California.
"March-in rights: CIRM will retain march-in rights in the event of: Failure to develop CIRM-funded discoveries, public health and safety reasons"
The agenda contained no draft of proposed rules or any discussion of the pros and cons of the concepts outlined above. But they do suggest that the agency may push to make discoveries available widely as well as to often ignored groups of patients.
It is not likely that these concepts will go far to satisfy those who want major changes in the current economic models for IP and taxpayer-funded stem cell research.
Saturday, December 03, 2005
Tight Budget, Hiring Freeze for CIRM
The $5.4 million spending plan, prepared by CIRM staff, is up for consideration this coming week by the Governance Subcommittee and by the full Oversight Committee.
The proposed budget is for 2005-2006 and compares to $3.9 million in spending for 2004-2005, which actually only covered about seven months while CIRM was just coming into existence.
The proposal calls for a cap on the existing staff level at 19 persons. Salaries and benefits are the single biggest item at $2.4 million. Contracts with outside agencies or businesses consume $1.3 million. Meetings and conferences are budgeted at $626,000($260,000 for working groups, $196,000 for the Oversight Committee and subcommittees and $170,000 for CIRM-sponsored scientific meetings and conferences).
The budget documents (see them here and here) contain no information on the status of efforts to sell bond anticipation notes to finance the $38 million training grant program.
The documents can only be found on the agenda for Oversight Committee meeting Tuesday. Although the Governance Subcommittee is scheduled consider them a day earlier, they were not available on the Web at the time this item was posted.
Friday, December 02, 2005
CIRM Contracts Hit $1.8 Million
The agency also is likely to boost payments to the law firm of Remcho, Johansen & Purcell of San Leandro by $252,200, bringing the total for the firm to $772,200. The amount could increase as the cost of litigation against CIRM rises.
Remcho has the biggest contract with CIRM. The Edelman PR firm is No. 2 with a $378,000, 12-month contract that began last April. Only $152,068 had been paid to Edelman as of Oct. 31, the latest date for contract information from CIRM. Edelman is also performing PR work for the Alliance for Stem Cell Research of Santa Monica, an organization that morphed out of the California Research and Cures Coalition, a group formerly chaired by Robert Klein, now chairman of CIRM. The value of Edelman's contract with Alliance is not known.
At the other end of the scale, Shred Works, Inc. had a $960 contract for "confidential destruction."
The latest figures for the contracts were posted on the CIRM Web site as part of the agenda for next Tuesday's meeting in Duarte. Also on the agenda is the agency's budget, formation of a strategic planning subcommittee and a report from the task force on intellectual property.
While the meeting is less than two working days away, no background information for the meeting was available to the public on either the agency's budget or intellectual property as of the time of this posting.
Thursday, December 01, 2005
The Voices of the Stem Cell Barristers
Reporter Marc Strassman also offers more details on what the lawyers have to say about discovery in the case. Both sides predict a spring trial.
Another Year for Legal Squabbling
However, reporter Andrew Pollack quoted stem cell chairman Robert Klein on his estimate of the length of the legal proceedings. Another year is what he said. The full story is here.
Conflicts and Records Targeted by CIRM Foes
Reporter Carl Hall of the San Francisco Chronicle offered up a few more details this morning of the anti-CIRM strategy in the wake of Tuesday's court ruling to proceed with a trial on the challenge to the agency.
He quoted Dana Cody of the Life Legal Defense Foundation in Sacramento, one of the opposing attorney, as saying she and her colleagues intend "to amass extensive evidence during the discovery phase leading up to a trial."
"One of her allies, David Llewellyn, who represents the bioethics group, said he looked forward to documenting 'very clear' financial conflicts among those charged with distributing Prop. 71 grants.
"He said the plaintiffs also would show that voters had been misled during the 2004 campaign about the real cost of embryonic stem cell research -- interest expenses on the $3 billion in grants, for instance, are estimated to total as much as $3.7 billion over the long run -- and the likelihood of a payoff for taxpayers anytime soon.
"Litigation hasn't yet been filed to block the expected $50 million financing plan, but Llewellyn said that might happen once state officials moved toward selling special 'bond anticipation notes' to investors who would be repaid only if the lawsuits were resolved and the Prop. 71 bonds were sold," Hall wrote.
Meanwhile, the San Jose Mercury News editorially called on
the judge in the case to dismiss the whole matter on Tuesday. Don't thwart the will of the people was the newspaper's position. It also said:
"It's true that Prop. 71 left inevitable gaps in areas of ethics and accountability. No proposition of this magnitude will ever dot every 'i' and cross every 't.' But the Legislature, led by Sen. Deborah Ortiz, D-Sacramento, is working hard to close those gaps and made significant progress in the last legislative session."