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.
Monday, April 11, 2005
Inside Robert Klein
Here is one quote from the article:
"If there's one thing that I would say about Bob, it's that he makes things happen when other people are trying to stop them from happening," said Chris Miller, a New York marketing executive who has been a friend of Klein's since they both worked on John Tunney's successful 1970 Senate campaign.
"When he decides to help you, you get helped," she said.
The piece notes the criticism that has been directed at Klein.
“Some of the attacks seem motivated as much by discomfort with Klein's hard-charging style as they are by unhappiness with the program. Characteristically, none of it seems to faze Klein.
“During two interviews and many briefer encounters since the November election, Klein makes it clear he has no time for distractions, little patience for Prop. 71 opponents and seemingly infinite faith in his own ability to get the job done,” Hall wrote.
The piece also reported that Klein's grandfather supported Upton Sinclair's California gubernatorial campaign during the Depression, which is a fascinating story by itself.
Profiles like Hall's are quite useful and all too rare in newspapers. They help provide insight into what makes public figures tick. Too often there is an excessive but understandable focus on tangible rules, procedures and actions while the real action is more ambiguous and based on relationships and motivations.
The Conundrums of Conflicts
By most measures, Battey appears to be qualified to head CIRM. He is head of the National Institutes of Health's stem cell program, but is retiring in September.
He is not alone. Three other high level researchers are leaving the NIH because of the new rules.
The case of James Battey, his colleagues and the NIH illuminates some of the conundrums of conflicts of interest. The situation suggests that conflict policies should start out very restrictive and be eased later, if necessary. It illustrates the very real personal burdens that can laid on top researchers and others. And it demonstrates some of the difficulties in controlling the most insidious sorts of conflicts, the ones arising from a lifetime of belonging, so to speak, to the same club.
Battey said he is leaving the NIH because “the new rules imposed an insurmountable problem for me,” according to a piece in the Washington Post by Michael S. Rosenwald and Rick Weiss.
“I manage a family trust...which supports the education of my father's seven grandchildren, and it contains assets I'm told I'd have to divest. That would cost a lot of money, and I can't do that to my family,” Battey was quoted as saying.
Quite justifiably he may think that the situation is not fair. He once operated under the rules, but then the rules changed through no fault of his own. As a result, the NIH is losing a valued executive and scientist.
An identical situation could occur in California if it has to toughen its conflict standards someplace down the road. It could lose valued employees as a result and then waste time, energy and money replacing them. Better now to be more restrictive than face embittered staff later.
The NIH situation shows how individuals can personally feel the burden of complying with conflict standards, something critics do not always seem to fully understand. It goes beyond consulting arrangements that yield hundreds of thousands of dollars in compensation.
One cancer researcher with the NIH was recently told she could not accept a $200 train ticket to present a paper at a conference for a physician's education group, according to the Post. The researcher said it was embarrassing to cancel her appearance.
The newspaper quoted a legal opinion prepared for a group of senior agency scientists that laid out the scope of the new conflict policy.
"Basically (it) means anything NIHers do outside -- whether getting paid for it or not, from singing in a jazz group to selling art or jewelry, from volunteering at charity organizations to membership in a school or community organization to developing their own small business completely unrelated to biomedical science -- requires prior NIH approval," the memo says.
"We find this very disturbing,” the scientists said. “It is intrusive and scary. It suggests the NIH owns our lives away from work."
The NIH rules additionally touch on the web of relationships that nearly all successful persons build during their careers. The Post said that many NIH employees are barred from holding executive positions with trade or professional organizations, even on a volunteer basis.
One NIH researcher said it could lead to an unpleasant backlash. “We will be cut off, disenfranchised from our academic colleagues.”
Most conflict codes, including the ones now in place at CIRM, can't deal with the ambiguous issues that can arise from the relationships that are built during a career. Sometimes they are formal as in leadership positions in professional organizations. Other times they involve informal or past connections to men and women who have assisted a person during his professional or business life, either financially or with advice or friendship. Sometimes it is training and shared experiences that create a way of thinking that imbues a person's approach to business or science.
The California stem cell agency has built into it a reliance on persons you might call “members of the club” who dominate the Oversight Committee. They bring special expertise, experience and skills to the effort, which is to be valued. They also bring a lifetime of comfortable relationships with other accomplished persons, people they have worked with, rely on and trust. It would be unrealistic not to expect them to go back to these people to seek their help and to help them.
It is also unrealistic to expect codes to catch all of the subtle conflicts and abuses that can and do come up involving such relationships. The best watch dogs, in fact, are other members of the Oversight Committee and CIRM employee peers. They may be the only ones who can stop a breach before it becomes serious enough to become a scandal.
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We welcome and will publish comments on CIRM or the failings of this blog. Please send them to djensen@californiastemcellreport.blogspot.com.
Moving Forward
The agency has persevered under much pressure and cranky public attention, dating back to its first meeting only last December. Critics have pummeled the panel. The press has been sharply critical. But rules are now place.
Yes, they are not perfect, but no such effort ever is. More hearings on conflict issues are scheduled for later this year, allowing possibilities for changes and fine-tuning. This is marathon for the Oversight Committee – not a 40-yard dash.
Saturday, April 09, 2005
The Tin Ear of the Private Sector
There is a certain amount justifiable self-interest as well.
Millionaire Ed Penhoet, vice chairman of the Oversight Committee, told Terri Somers of the San Diego Union Tribune, "I'm spending an enormous amount of time and effort purely in the public interest. I'm not willing to sacrifice the entire rest of my life, which has been in the biotech world, because it doesn't make any sense."
However justified Penhoet's statement may be, it demonstrates one of the differences between the private sector, which has provided many of the Oversight Committee members, and government. A skilled practitioner in the public sector would not have said what Penhoet did. It's impolitic and can be misconstrued. It sems to indicate that he would place his private business above his public responsibilities. And it implies a petulant belief that it is wrong even to ask questions about possible conflicts.
The stem cell agency is continuing its drumbeat that the charges of the critics are meritless because they fly in the face of the will of the people as expressed in November's election. This is a dangerous argument that is not in the best interests of the agency. It places the agency on a collision course with all critics, however warranted their criticism. It has already pushed stem cell agency supporters into hostile positions in which they have formed alliances with those whose greatest desire is close down the agency.
The objectivity vs. expertise argument was also engaged last week as part of the reaction to charges by the Center for Genetics and Society. Somers' story and one by Steve Johnson in the San Jose Mercury News touched on the subject.
Friday, April 08, 2005
Light Coverage of Thursday's Meeting
A quick check showed only two major newspapers with their own stories and no story from The Associated Press, which feeds coverage to thousands of outlets worldwide.
The San Diego Union Tribune (Terri Somers) and The Sacramento Bee (Laura Mecoy) had staff written stories on the approval of the conflict of interest codes. The Los Angeles Times, the San Francisco Chronicle and the San Jose Mercury News carried none, based on a look at their web sites. A search of the Internet turned up no other stories in California newspapers, although there may have been some.
There are a couple of reasons for this. One could be deadline problems. Reporters may have been there but filed stories too late to be placed in the paper. The other may be that the novelty is wearing thin. Newspapers only skim the top of most events. They turn away from issues that seem to be getting old, even if they are fundamentally important. And the conflict of interest flap has been written about repeatedly since the agency's first meeting in December.
We may yet see additional stories from this week's meeting, perhaps on Saturday or Sunday.
Wednesday, April 06, 2005
Critics: Conflict Code Not Up to Snuff
The Center for Genetics and Society noted that seven members of the committee have significant business connections with companies connected to stem cell research.
“Managing $3 billion in taxpayer money is an enormous responsibility, and it should not be done by those who have a personal financial stake in how it is used,” said Marcy Darnovsky, associate executive director of the center.
“The proposed conflicts policy sounds good on first reading, but all it really requires is disclosure and self-recusal,” said Jesse Reynolds, the center's program director.
“Because of mutual understandings among board members based on longstanding relationships and financial interests, real oversight would be almost impossible. That’s why we support divestment, not disclosure,” he said.
The center's press release said that Oversight Committee vice-chair Edward Penhoet and members David Baltimore, Tina Nova, Gayle Wilson, Keith Black, John Reed and Brian Henderson have investments and/or leadership positions in companies which are or have been involved in stem cell research.
The center's research can be found here.
A Tale of Two Codes
Both policies appear straight forward and relatively strong, given that the Prop. 71 has inherent conflict of interest problems written into it. What is mainly different is language in the code for employees that declares the agency must “conduct its activities in a way that is perceived to be open, fair and free from bias.”
“CIRM employees must be free from both real and apparent conflicts of interest,” the code says.
The code for the bosses -- the CIRM Oversight Committee -- makes no mention of perceptions or “apparent conflicts of interest.” In fact, it specifically exempts deans of medical schools from situations that appear to raise perception issues.
“Deans of medical schools and executive officers of research institutions oversee and advise researchers in their institutions and sign off on all grants as part of the basic duties of their position. This activity shall not be deemed to be a conflict of interest,” the policy states. But it does require such oversight committee members to recuse themselves from decisions on such grants.
One wonders why the “perception” language was not included in policy for the Oversight Committee. It may be that the code writers came to the conclusion that the committee members could never avoid the possibility of perception problems.
Another interesting aspect of the employee code is the ban on financial interests in a organizations with a “substantial” interest in stem cell therapy.” That is defined as “one in which more than 5% of the research budget is known to be devoted to stem cell therapy.”
Could the “known-to-be” language be construed to exempt investments in privately held enterprises, whose budgets are secret?
The policy for employees also presumably applies to consultants to the agency, such as attorneys and computer security analysts. However, there is a provision in the language approved at the last meeting that gives vast leeway to an aide to the chairman (not the president) to exempt consultants from the type of disclosure that ordinary employees would have to make.
Not dealt with in the two codes are perceptions involving entities seeking the permanent headquarters of the agency. Earlier the agency said one of the requirements of the lease is a "letter signed certifying that the owner does not have and will not have in the future any ownership interest in any firms or agencies competing for grants to be awarded by the Institute."
We raised questions on Feb. 28 about the definition of “ownership interest.”
If the employee standard is applied to landlords, it will mean investments of more than $10,000. One might wonder whether the landlord ownership ban would also apply to the principals of a firm that the landlord hired to do janitorial work at the permanent headquarters.
Under the best circumstances, it is impossible to write a conflict of interest code that covers all possibilities. It is particularly difficult with CIRM because some of the Oversight Committee members have longstanding and deep ties with parties that could stand to benefit from actions by CIRM. All that is legal but some critics have raised questions whether it is right.
Given that situation, it would behoove the agency to act with an abundance of discretion in matters involving perception and appearance, whether in the case of Oversight Committee members and employees or consultants and landlords.
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We welcome and will publish comments on the conduct of CIRM and the failings of this blog. Please send them to djensen@californiastemcellreport.blogspot.com.
Tuesday, April 05, 2005
Chiu Named Science Director
Currently she is a developmental neurobiologist and Associate Director of the Office of Research Administration of the National Institute of Biomedical Imaging and Bioengineering – one of the National Institutes of Health.
She is the first appointment of interim stem cell agency president Zach Hall. Her new title is director, scientific programs and review.
"Recruiting Arlene Chiu as our first scientific appointment is a major coup for the Institute," said Hall. "She is undoubtedly the most knowledgeable scientific program director at NIH about stem cell research world-wide. Of the many candidates who applied, Arlene's strong research background and administrative experience made her a clear first choice for this position."
The CIRM announcement said, “At NIH, Dr. Chiu was a leader in organizing stem cell research programs, serving on both the NIH Stem Cell Task Force and on the NIH Stem Cell Implementation Committee. She organized the first NINDS workshop on stem cells, as well as an international meeting in Sweden to promote collaborations between investigators in the US and abroad. She also represented the United States at stem cell conferences in England, Korea, Sweden and China. At NINDS, Dr. Chiu also led efforts to promote cooperation with the U.S. Food and Drug Administration in expediting the use of stem cells in therapies. She has co-edited, with Mahendra S. Rao, a leading book on stem cell research entitled Human Embryonic Stem Cells.”
More Information, More Complaints
Reports, minutes and background material are finally beginning to appear as links in the full agenda. On the site are such things as a list of names of persons being considered as ethicist members of the Scientific and Medical Accountability Standards Working Group.
That item also shows that some members of the Oversight Committee continue to be unhappy about the agency's processes for making important decisions.
The minutes from the Scientific and Medical Accountability Standards Working Group Search Subcommittee said that Joan Samuelson, head of the Parkinson's Action Network, “felt very strongly that she did not have enough information on the candidates other than those which were on her list to vet and felt insufficiently informed to make a final decision on candidates at this meeting.”
Jon Shestack, vice president of Cure Autism Now, also was displeased. “Shestack echoed Joan Samuelson’s concerns about this committee’s process of identifying candidates and the compressed timeline in which the subcommittee was asked to carry out this task,” the subcommittee report said.
The upshot was that the “subcommittee (was) divided in terms of how to proceed and (slowed by ) persistent resistance to moving forward with voting on another ethicist candidate.”
Monday, April 04, 2005
Fumbling the CEO Search
The subject comes up again this week – and again on a tight schedule, which seemed to play a role in generating frustration and complaints from Oversight Committee board members. The conduct of the search firm, Spencer Stuart, also came under fire. Chairman Robert Klein promised to hold a “very significant discussion” with the firm.
The problems arose when the search subcommittee held a meeting to discuss criteria for the position, which is expected to pay about $400,000 annually. Although a quorum was not present, the group made suggestions that were to be forwarded to the full Oversight Committee the next day.
But when the time came to discuss the recommendations, none of them had been included in the material provided to the full board by Spencer Stuart, giving board members an unpleasant surprise.
Klein initially pushed to keep the selection process moving forward, which some board members favored. But he finally agreed to take the whole matter through the subcommittee process again, according to a transcript of the meeting.
That was after several Oversight Committee members including Phyllis Preciado, a Fresno, Ca, physician, and Joan Samuelson, president of the Parkinson's Action Network, expressed displeasure with how the matter was being handled.
“I would much rather do this in a deliberate way that allows the entire committee to be able to weigh in on the specifics of the job description and the other details,” said Samuelson.
“This is an enormously important decision. And it's not only that the wrong document is here, but there wasn't any time for anybody to review it. We got tens of pages."
Francisco J. Prieto, a Sacramento, Ca., physician, said, “I think we have to appreciate that, as a public enterprise, we are sometimes going to have to sacrifice efficiency for openness."
David Baltimore, president of the California Institute of Technology, said he was surprised by the absence of the search firm from the Oversight Committee meeting.
“They should understand the various concerns around the table.... If they were running a search for me, they would have been here.”
At one point, the discussion degenerated into talk about the logistics of running more teleconferencing sites so Oversight Committee members could more easily weigh in remotely at subcommittee meetings.
“Isn't there a simpler way to do this?” asked Committee member Sherry Lansing, a Hollywood entertainment executive, concerning the subcommittee's suggestions.
It is not clear exactly what is on the table for this week. The presidential search subcommittee has only one item on its agenda for Wednesday, a closed door executive session. The next day the Oversight Committee is scheduled to take up a status report from the subcommittee and criteria for selection. It has also scheduled an executive session on the presidential search.
The status report of the presidential search subcommittee was not available online at the time that this item was posted on the Web, two days before the Oversight Committee meeting.
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We welcome and will publish comments on CIRM or the failings of this blog. Please send them to djensen@californiastemcellreport.com.
Sunday, April 03, 2005
Difficult Questions: Eggs to FDA
What kind of privacy protections should be in place for cell donors? If they are guaranteed anonymity, what happens when later research turns up information that could be medically important to the donor?
In the international world of stem cell research, how are conflicting standards reconciled between nations?
When does the FDA become involved?
These are just a few of the questions facing California's stem cell agency. Alta Charo, a bioethicist from the University of Wisconsin, last month briefed the CIRM oversight committee on these and other legal, ethical and practical issues facing the agency.
Her comments are now available online in a transcript from that meeting. While they are looser than a formal text might be, they give a valuable overview and some insight into a few of the concerns of committee members.
Charo's subjects included protection of human subjects, privacy, reimbursement of donor expenses, international and conflicting patient and research standards, international collaboration, FDA involvement, stem cell banking, underlying medical conditions of donors and more. Some of her comments were brief but all illuminated one or another subject and are worth reading.
Here are samples from her presentation:
“Just working with cell lines, just collecting the embryos functionally means you are in a position to be studying the donors and not just their materials, and it's the ability to study the donors as people that triggers the need to treat them as research subjects.”
“How much should be told to your potential donors about the range of research uses? There are research uses that are coming down the pike that are probably going to sound very alarming to most members of the public. These might include genetic manipulation of the embryonic stem cells. That is already going on if only to just insert markers so that one can actually observe where the cells are differentiating.”
“Even the context of reimbursement has some ambiguities built into it,” Charo said. She cited examples of preferential medical treatment for donors or in-kind benefits such as fertility treatment, in addition to the possibility of donors requesting reimbursement for “outlandish” travel expenses. “You may find it worthwhile to simply make (language in Prop. 71) that much more explicit so there's no possibility for confusion.”
$4,000 Donors
The piece included an interview with Zach Hall, interim president of the stem cell agency.
“He estimates it will take about 20 eggs to produce one successful nuclear transfer. About 10 eggs can be harvested from a woman at a time, he said. That means fewer than 1,000 donors would be needed for 300 new stem cell lines, which should be enough for the next few years, Hall said.
Kleffman continued, “The Bedford Research Foundation near Boston is believed to be the only place in the nation now collecting eggs for research purposes.
“It has paid about 20 women an average of $4,000 each to be donors. Participants tend to be young women who have a family member with a disease they hope can be cured with treatments based on stem cell research, said foundation director Ann Kiessling.”
Perhaps this may sound callous, but that price sounds like it does not reflect true market value. I am sure there some economists out there who could tell us what occurs when prices are artificially low or high.
Ortiz Heaing on April 20
The measures are authored by Sen. Deborah Ortiz, D-Sacramento, chair of the Health Committee. Often hearing dates change, so keep in mind that this could be rescheduled. The measures are SB18 and SCA 13, which is a proposed constitutional amendment.
Friday, April 01, 2005
Consider This
Nominally the agency has posted its agenda on the Internet. The brief document provides some general hints on matters to be discussed, such as its first step towards issuing $3 billion in bonds (see item below).
However, most of the agenda consists of ambiguities that are of little help to members of public, businesses, academicians or scientists about whether it is worth their time to attend the session.
“Consideration” is the key word. Virtually all of the agenda items that might appear to be substantive are listed for “consideration,” such as “consideration of conflicts policy for ICOC (oversight committee) members.” Other subjects to be “considered” are:
- Working group policies, including confidentiality, meeting format, conflict of interest, compensation and chair positions
- A report from the standards working group search subcommittee, including but not limited to consideration of appointment of members (5 ICOC patient advocates, 9 scientists, and 4 medical ethicists) to the standards working group
- Conflicts policies for the CIRM staff
It is impossible to tell whether the matters will be voted on, amended, written, proposed or merely discussed at the meeting. In fact, it is next to impossible to determine their specific nature.
For example, a report to be considered from the grants subcommittee, which is a key group for dispensing hundreds of millions of dollars, is not available online. Nor are either of the latest versions of the conflicts policies. Last month, a draft of the conflicts policy for the oversight committee was available online, but it is unclear whether that document is the one to be discussed or whether it has been altered.
As for the staff conflict policy, the oversight committee approved a “statement of incompatible activities” at the last meeting. It is unclear whether that is up for amendment or reconsideration or whether entirely new restrictions are up for approval.
While the lack of information is troubling for members of the public, it is even more so for members of the committee, busy people who have other issues before them besides the stem cell agency. If they do not have sufficient time in advance of the meeting to read background material and reports, it makes it difficult for them do their jobs properly.
As for the public and other interested parties, it is nearly impossible to make informed comments to the agency during its three-minute comment periods unless background material or texts of proposals are provided in advance. Most of the matters the agency is dealing with are complex and deserve careful thought as opposed to something generated on-the-fly at a busy meeting.
Chairman Robert Klein has promised the highest and best standards for the stem cell agency. However, even local school districts in California do a better job of making background material available to the public in advance of meetings.
The stem cell agency is still young and understaffed, but there is no doubt that it can do a better job at maintaining openness.
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We welcome and will publish comments on the stem cell agency or the failings of this blog. Please send them to djensen@californiastemcellreport.blogspot.com.
Correction
Wednesday, March 30, 2005
Here Comes $3 Billion
The oversight committee of the agency meets one week from today in Los Angeles, only the fifth meeting since it came into existence. On the agenda is a resolution that would set the bond process in motion.
Also on the agenda is Christian right litigation that has raised uncertainty about the bonds and seeks to terminate the agency itself, despite that the fact that it was created by voters approving an amendment to the California state constitution.
Chairman Robert Klein has promised to come up with a strategy to squelch the bond uncertainty at the April meeting. Just what that is will have to wait until after a closed- door litigation session at the meeting.
Also on the agenda is an item that could speed some of the processes at CIRM. It calls for charging the institute staff with developing a proposal for the agency's research grants program. The staff proposal would then be considered by the full oversight committee at the May 6 meeting of the oversight committee.
The schedule for next Wednesday additionally calls for “consideration” of a host of issues including: conflict policies for oversight committee members and agency staff, policies for working groups including confidentiality and conflicts issues and a training grant program for future stem cell researchers.
Tuesday, March 29, 2005
Super Ovulation and Ortiz
Mecoy, who writes for The Sacramento Bee, explores the reasons for Ortiz' position, which has greatly disappointed some who used to consider her a staunch ally. Ortiz, on the other hand, says she is not abandoning them.
She told Mecoy, "I just want to have a full discussion because we are changing from what we said during the campaign (for Prop. 71), and that troubles me."
The measure itself recognizes some of the problems with the issue, barring purchase of eggs from donors but apparently allowing for compensation for expenses.
Substantial money is to be made from stem cells as they are turned into medical products. That invariably will entice some to skirt, at the minimum, the edges of ethical behavior, which are not all that clear on stem cell matters anyway. Ortiz' concern seems merited.
But Mecoy also notes that at the same people are in misery. She quoted a mother of two in Davis who suffered a spinal cord injury 12 years ago.
“Three more years ... could be a matter of whether I make it out of this
chair or not," said Karen Miner. "I don't understand this push to delay this for three more years when we have all fought so hard, and people are dying."
Monday, March 28, 2005
Citizen-bioethicists and Stem Cells
In what may be the only course of its kind in the country, students are examining the conduct of the agency and stem cell issues in general.
Topics for this week's classes are “Going Corporate: Patenting and Secrecy” and “Markets for What?” The class readings on the subjects include the websites of both Geron and CIRM. Also required this week is a book titled “Body Bazaar: The Market for Human Tissue in the Biotechnology Age.”
The class is called "Rhetoric of Scientific Discourse: Stem Cells, Cloning, and the Genetic Imaginary." Rhetoric and women's studies professor Charis Thompson devised it to analyze ethical and political implications of cutting-edge scientific proposals and activity. She taught a similar class at Harvard University before joining the UC Berkeley faculty in fall 2003, according to a report by Noel Gallagher, a writer for the Berkeley campus.
"We are increasingly being asked to act as what I call 'citizen-bioethicists,' and to have political and personal opinions about scientific, technical and medical matters," Thompson told Gallagher. "This class is an attempt to outfit us for that role."
The first assignment for the 30 undergraduate students in the course was to read the full text of Prop. 71, making them part of the handful of persons who have actually done so.
The class began in January and will end in May. In the meantime, students will dig in such areas as “links between democracy and science” and “governance and genetics.”
Thompson told us that she has a grant that will enable 8 undergraduates and 2 graduate students to continue research in the area. She also said, “I am working with the oral history group on campus to begin a stem cell archive. In theory the class, or a variant of it, as issues develop, will always be offered in the spring.”
Friday, March 25, 2005
Business, Politics, Stem Cells and Steve Westly
Her points are good and often not well understood by students of business or politics. Having worked in both politics and government and in the private sector, including entrepreneurial roles, I can vouch that some of the skills are the same but some are different. The different frames of reference that are required may be what give crossover efforts difficulty. But it can be done. Felix Rohatyn, who was instrumental in rescuing New York City from bankruptcy many years ago, is one person who comes to mind as a skillful practitioner of politics and business.
The eWeek column begins: “Robert Klein, the Palo Alto, Calif., real estate developer who pushed the measure to passage, has been making some serious missteps, sending the wrong signals about how he'll deal with state officials.
“His organization, the California Institute for Regenerative Medicine, and the 29-member panel that oversees its work, the Independent Citizens Oversight Committee, have run into trouble over what—to a businessperson—sound like technical details.”
Nolan also writes about the agency on her “Politics Left and Right” blog, which suggests, among other things, that State Controller Steve Westly provide some additional assistance to CIRM.
She says he is “a creature of Silicon Valley (who) understands how guys like Klein think (and) was an early and eager back of the stem cell proposition because he correctly saw it as a jobs measure. He's also been friendly with Gov. Schwarzenegger who, it seems, taught Westly a few things about political grace while the pair went campaigning together last year. Westly's got financial oversight responsibility for Klein's committee; he's perfectly positioned to take some irons out of the fire here. And he ought to do it. This could very quickly become a intra-mural Democratic party fight. Or worse.”
Next Step in Lawsuits
Robert Klein, chairman of the agency, told the San Francisco Chronicle he would offer an “alternative” plan at the board's meeting early next month.
Reporter Bob Egelko wrote, " 'As long as there's a challenge pending, there's a cloud over issuance of the bonds,' said Deputy Attorney General Tamar Pachter, the state's lawyer.”
One tactic would be for the agency to file its own suit to force a decision on the issues.
Here are links to stories by Paul Elias of The Associated Press and Laura Mecoy of The Sacramento Bee on the case.
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Wednesday, March 23, 2005
The Fallacy of the Will of the People
Bad news for this blog and bad news for those who argue that Prop. 71 represents the will of the people.
For those of you who recall that Prop. 71 was approved by 59 percent of voters, the apparent lack of support may come as a surprise. But just as in business, there are numbers and then there are other numbers. Ask Bernie Ebbers, former CEO of WorldCom.
Robert Klein, chairman of the stem cell agency, and others cite the 59 percent figure as a justification for keeping bothersome legislators out of their business. Prop. 71 is the will of the people, they say. What they fail to understand are the real numbers and their significance. Say “aw shucks” to Mr. Ebbers.
Given the recent controversies involving the agency, what its supporters should be concerned about are the 15 million Californians – 68 percent of the voting population -- who either opposed or did not feel strongly about Prop. 71 in last fall's election. That group represents an opening, a potential market for those would seek to destroy CIRM.
Before we venture on, let's look at the numbers from last fall. California's secretary of state reports that in the November election, the state counted 22 million eligible voters, meaning “the people.” Only seven million supported Prop. 71 – 32 percent of eligible voters. Another 4.9 million – 21 percent of eligible voters – opposed it.
How can this be, you might ask, given the 59 percent approval figure? It is fairly simple. That number is derived only from the people who voted, and many did not.
Out of the 22 million possible voters, only 16.6 million chose to register to vote. Minus those who actually voted for or against Prop. 71, that leaves 4.7 million registered voters who skipped right by Prop. 71 and another 5.6 million people who just did not care at all (did not register to vote). Add up the opposition voters (4.9 million), registered voters who chose not to vote on the measure (4.7 million) and those who did not register vote (5.6 million) and you have roughly 15 million people, give or take a few because of rounding.
President Bush and his minions last year taught us all a lesson about numbers like these. They looked at the persons who ordinarily did not vote. They mobilized them (mainly using the Christian right), energized them and thrashed John Kerry.
There is nothing new about people not registering or not choosing to vote once they are registered. But it means that Klein and company cannot find much solace in the 59 percent figure. It could easily turn into so much dross. Last fall's election was dominated by presidential politics. Most observers agree that voters did not look closely at Prop. 71, along with a bunch of other state measures. A substantial segment of the population, properly motivated, could turn on CIRM, a situation that a fledgling bureaucracy does not need.
If these numbers come as a surprise, it is because the media and others, for years, have become comfortable with using a flaccid shorthand. The persons who cast ballots become “the people.” Forgotten are the rest who rise up from time to time and do strange things.
On March 16, Klein said that “the voters of California sent a clear message.” Perhaps or perhaps not. But there is certainly an opening for the enemies of CIRM, especially since an oversight measure could be placed on the ballot next fall. The chairman might best heed the counsel of Zach Hall, the new president of the agency, who said on March 9, “The success of our venture will critically depend on the confidence of the people of California in our integrity and credibility. Decisions made by the Institute must be transparent and must be perceived to be fair and objective judgments based on scientific merit, free of bias and conflict of interest.”
Needless to say, “perceived” is a very important word for the agency.
Tuesday, March 22, 2005
Lee-Halpern Petition Rejected by Klein
Writing this morning, she said:
"The chairman of the state stem cell agency's oversight board rejected every point in a petition seeking more open meetings, stricter conflict-of-interest rules and salary caps at California's new research institute.
"But with pressure mounting in the Legislature and the courts to address these issues, the chairman said Monday the panel would hold hearings seeking a wide range of views on each issue - rather than limiting itself to the petitioners' views.
"These are important issues which we have set up public hearings to address," Chairman Robert Klein II said. "But to make a deal with a special interest group is not consistent with the interests of the public in having a full public hearing of these issues."
Blogosphere Simmers with Stem Cell Commentary
In recent days,we have seen a spate of postings. They include a blog on the website of the influential Washington Monthly magazine and on the website of the American Journal of Bioethics.
Kevin Drum, who writes the Political Animal blog for Washington Monthly, called Prop. 71 “something of a sweetheart deal written by the biotech industry and rather clearly for the benefit of the biotech industry.”
His item triggered a string of comments, including one from a writer called Platypus, who described him(her)self as a “molecular geneticist who has reviewed grants for one of California's other targeted research programs (the California Breast Cancer Research Program).”
“There is almost certainly a large mismatch between the amount of money that is suddenly available ($300 million/yr) and the number of California-based researchers who currently are carrying out high quality stem cell research,” Platypus said. “So, a major challenge/serious problem is how to spend the money wisely. Right now you could fund all the really great stem cell research projects in California on a fraction of the available money.”
“So, what do you do with the rest of the $300 million/yr? Some of it could (and should) be used to build up research infrastructure and lure additional stem cell researchers to California, However, any benefit from this expansion in research capacity will take years. In order to show that Californians are getting immediate results for their tax dollars, there will be great political pressure to fund as many projects as possible as soon as possible, resulting in wasting a good deal of the public's money on mediocre (or worse) science.
“I hope the program succeeds, but it's going to be difficult to carry out successfully. The initial structuring of the program is key, so that it not turn into the California Biotech Industry Relief Act of 2004.
“Finally, you can't just buy a scientific breakthrough, no matter how much money you throw at the problem. There is great danger in misleading the public as to what we can and can't do as medical researchers.”
David Magnus, writing on blog.bioethics.net on the website of the American Journal of Bioethics, noted that Prop. 71 insulated funding and management from state lawmakers. He said the tough issues that must be faced are better handled by the stem cell agency's oversight committee rather than becoming "fodder for political gamesmanship in the legislature.”
“Unsurprisingly, the state legislature is unhappy with the fact that they are not relevant to an important undertaking within the state. State Sen. Deborah Ortiz (possibly motivated by a desire for higher public office) has abandoned her long standing support of stem cell research and is attempting to subvert the expressed will of the people,” said Magnus, who is director of the Stanford Center for Biomedical Ethics.
He cited Ortiz' measure to make it “illegal for women to voluntarily serve as oocyte donors for the expressed purposes of research (since in practice these women take drugs to superovulate to produce a sufficient number of eggs).”
“It is worth noting,” Magnus said, “that women routinely do this in IVF, and in fact, there is nothing to prohibit women from continuing to produce eggs as surrogates for other people trying to reproduce. Apparently Ortiz believes that assisting reproductively challenged individuals is sufficiently important that women should be allowed to make this decision, but research is not important enough to allow anyone to expose themselves to risk.
“This issue highlights the difficulty of turning these matters over to a legislature that fundamentally lacks knowledge or insight into the research process or into the details of the practice of medicine. The citizens of California wisely chose to pass a measure that had built in measures for oversight and public accountability—the fact that the legislature is left out is a poor reason to undo the will of the people.”
On the Local Liberty blog of the Center for Local Government at the Claremont Institute, Matthew Peterson deplored the “irrational pandering of California cities in their mad quest to land the offices of the CIRM. One of the best summaries is, no suprise, posted on a blog(editor's note: Peterson was referring the “lusting” item on this blog).”
He added, “It's all too easy to simply throw money down for a quick fix—such fast food solutions inevitably lead to failure.
“In this case, even the friendliest supporter of all things CIRM has to stop and wonder. Sure there are ways in which the offices will bring financial benefits with them, but isn't a big part of the radical pursuit of the 50 person office really stemming from a desire to have a "cool," "cutting-edge," "progressive" image?”
Peterson is writing a piece for the Claremont Institute which will explain why he believes the stem cell agency “combines the worst tendencies of modern politics: the promise of a New Man, democratic forms masking government in the shadows and taxpayer-subsidized bureaucracy.”
Monday, March 21, 2005
Two Critical Views of the Stem Cell Agency
The editorial said, "Given that (Chairman Robert) Klein seems disinclined to publicly lead the stem cell program, members of the Independent Citizens Oversight Committee should take this role upon themselves. Prior to the next meeting, this oversight committee needs to set its own agenda, and put the institute on a course that marries science with accountability."
Long time journalist and blogger Chris Nolan has provided insight into the thinking that may be part of the problems at the agency.
She wrote in Politics from Left to Right, "Some of what's going on here is a failure to understand the difference between private and public funding, a classic mistake made by business folks trying to work the political system and a profound weakness for that sometimes arrogant crowd known as Progressive libertarians. They want government to run like a business: Efficiently and with smart folks like them in charge. But there reasons -- lots of good ones -- that we have oversight and open meetings laws."
Correction
Friday, March 18, 2005
Lusting for the Stem Cell HQ
Lust is a good word for it. Longing for the permanent headquarters of the California Institute for Regenerative Medicine has prompted localities throughout the state to cough up commitments for crisis counseling to cops.
We have put together the following compilation of bids from a variety of newspaper reports over the past several days. It is only semi-complete, as is everything on this blog. Totally missing is San Mateo County, which was not available when we gathered the information. That is important because that county is where Robert Klein, chairman of CIRM, lives and does business. We will give you San Mateo when it weighs in.
Basically all the areas are offering free rent for 10 years. Some offers exceed the requested square footage by 3,000 feet. Links to a bunch of HQ news stories are at the end of this piece.
Keep in mind that this listing is based on what has been reported. Do not assume, for example, that Sacramento has not offered free health club memberships while others have. Probably it has not been reported in the press. Moreover, the negotiation process in the bidding will see many added incentives.
We are going to go with The Big Tomato (Sacramento) first in a blatant display of partisanship. This writer lived in the The Big Tomato for 21 years, most of which were a great pleasure. That said, we have been absent from the Golden State for more than six years. We have no financial interest anywhere in California, either in real property, biotechnology of any sort, venture capital, stocks or anything else, unless they are held in a mutual fund. But we do figure that listing Sacramento first in this rundown will give it the heft to put it over the top. Everybody else will have to be satisfied with alphabetical order.
Sacramento -- The city of Sacramento and the Angelo Tsakopoulos family made an offer the city valued at $7.3 million. It includes rent-free offices at One Capitol Mall in Old Sacramento, free parking and conference space, and up to $800,000 in cash for tenant improvements. The Angelo Tsakopoulos family also offered $450,000 in free utilities and services. Wendy Saunders, Sacramento's economic development director, said the city's contributions of conference space and parking were worth $750,000. Views of the Sacramento River are promised as well as a short jaunt to the Capitol itself.
Emeryville -- City leaders want to keep the headquarters right where it is now, in temporary facilities at the Emery Station office park on Horton Street, across the street from an Amtrak station. City officials said that slightly more than half of all U.S. biotech companies have their headquarters in the Bay Area -- a third of them in Emeryville, such as Chiron and Bayer corporations. The offer includes free health club, free use of Pixar Animation Studios' digital theater and gourmet kitchen; reduced rate hotel rooms for visiting scientists; free use of conference rooms at Chiron Corp.; free parking; free shuttles from BART. The current landlords have touted their connections to Chiron, one of whose founders is Ed Penhoet, who is vice chairman of the stem cell agency oversight committee.
Los Angeles – Space at City National Plaza downtown, along with $1 million in grants “to support administrative efforts,” private jet services, free round-the-clock concierge service, a police liaison and 10 free days of large meeting space.
San Diego – A $9 million offer, according to the city. But then it adds that it is “worth a million dollars (more) to be out there on Torrey Mesa overlooking Torrey Pines Golf Course and the Pacific Ocean, and to be surrounded by UCSD and some of the finest research institutions in America." San Diego offers a "readiness team" to assist in planning, coordination and startup of the facility, furnishings and systems and an "advisory council,"a group of top local executives available for advice, introductions within the community, resources and crisis support. Included are 100 hours of free legal services, free branding and marketing advice from public-relations firm Mentus.
San Francisco – The $10 million package includes 20,000 square feet of free office space in a year-old building at 250 King St., known as Mission Place, across the street from the Giants ballpark and a short walk to UC San Francisco's new biosciences campus in Mission Bay. It also includes free shuttles, discounted gym memberships and the use of City Hall, SBC Park and city-owned convention facilities for gatherings, free high-cost videoconferencing equipment and broadband access, free and discounted office furnishings, free and reduced-rate hotel rooms and limo service and no-cost Web communications.
San Jose – The San Jose mayor, whose name shall be omitted in this sentence because he is shameless, personally pony-expressed 10 copies of his city's 25-page proposal to Sacramento, all in the hopes of generating more press coverage. San Jose offered two locations: The Concourse in North San Jose Innovation Triangle, 1731 Technology Drive; or Fairmont Plaza downtown at 50 W. San Fernando St. Perks: $500,000 in free tenant improvements, free parking, on-site exercise facilities, cut-rate hotel rooms, free furniture, security liaison at San Jose Police Department, donated video and computer setups,free round-the-clock concierge service and 10 free days of large meeting space.
Here are links to many of the stem cell HQ stories: San Francisco Chronicle, San Diego Union Tribune, Sacramento Bee, Los Angeles Times, LA Business Journal, Silicon Valley Business Journal.
Thursday, March 17, 2005
A Litany of Losses
But the truly sad part about it is that much of the pain was unnecessary and is now hobbling an agency that was born with great expectations.
Here is a partial scorecard:
1. The agency now faces a potential ballot fight, possibly as early as next fall, if a proposed constitutional amendment to tighten oversight passes in time.
2. The bond market, where the agency hopes to raise billions, is judged to be skittish about any offerings given the current state of litigation against the agency.
3. Powerful supporters in the California legislature are now wary and suspicious, aligning themselves with those who would be ecstatic if the agency vanished from the earth.
4. Critical and nagging questions have been aired in the media across the country concerning the conduct of the agency. Given the pack nature of the press, more can be expected.
5. The personal integrity of the chairman of the agency has been questioned in the Capitol, with some describing him as a “megalomaniac” who is damaging the agency that he was so instrumental in establishing.
On the other hand, CIRM has appointed a well-regarded scientist, Zach Hall, as its interim president and adopted a conflict of interest code for its employees. Creating a new agency is a slow and tedious business, so it may be unreasonable to expect much more. CIRM yesterday, however, touted its progress by saying “we have now held 13 open public meetings in just 13 weeks.” Holding a meeting is about process as opposed to accomplishment, a fact that the businessmen and women on the Oversight Committee do not need to be reminded of.
The California Institute for Regenerative Medicine was certain to face controversy and opposition during its infancy just as it will during its entire existence. But some sort of honeymoon normally would have been expected. The promise of finding cures or treatments for everything ranging from diabetes to cancer is tremendously alluring. The agency also was expected to make California the stem cell capital of the world, creating jobs, attracting talent and generating prestige for the state.
But today the agency is under heavy assault. It is one thing to irritate the sometimes toothless watch dog groups. It is another to antagonize heavyweight lawmakers.
CIRM now must focus much of its energy in rebuilding support in the Capitol. It will need to do everything possible to prevent a constitutional amendment from being placed on the ballot to tighten controls over the agency. The last thing the agency needs is a statewide election contest over matters that should have been dealt with more skillfully. The sooner the issue is put to rest the better.
Such an effort in the Capitol will cost money and time, particularly time lost because of the distractions from the difficult and important business of creating a new agency.
A month ago, it certainly would have been much easier to discuss legislative concerns and arrive at solutions instead of dueling with press releases and nationwide Internet campaigns. No doubt some of the folks on the fringe would have never been satisfied short of taking their pitch to the California Supreme Court. But other critics seemed to be looking for some overt action as an assurance that their concerns would receive a serious hearing. That did not seem to be forthcoming.
In the wake of the jubilation over the passage of Prop. 71 less than five months ago, few would have foreseen the current state of affairs. Let's hope a new path can be quickly charted.
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We welcome and will publish comments on CIRM or the failings of this blog. Please send them to djensen@californiastemcellreport.com.
Coming Up Friday
"Welcoming" and News Coverage
But that was about as far as it went.
Here are links to some of the stories this morning on the stem cell agency, the proposed constitutional amendment and other proposals. We are also carrying on this blog the joint press release from the two California senators, the statement from Robert Klein and Ed Penhoet and the statement from the Center on Genetics and Society because not all of them are available on their various web sites at the time of this writing.
See the CIRM statement and the one from Genetics and Society for their "welcoming" comments.
Megan Garvey, Los Angeles Times; Carl Hall, San Francisco Chronicle; Bill Ainsworth, San Diego Union Tribune.
SENATORS ORTIZ AND RUNNER
INTRODUCE LEGISLATIVE PACKAGE TO
PROTECT PUBLIC’S INVESTMENT IN STEM CELL RESEARCH
SACRAMENTO – Senator Deborah Ortiz (D-Sacramento) and Senator George Runner (R-Antelope Valley) today announced they will introduce two bills and a Senate Constitutional Amendment to ensure public accountability in the implementation of Proposition 71, the stem-cell research initiative approved by voters in November.
“To maintain the public’s confidence, the integrity of this important research and California’s significant financial investment, we must make sure meetings are open to public scrutiny, strict conflict-of-interest and economic disclosure standards are developed, patients’ rights are protected and the state receives a fair financial return on its generous investment,” Ortiz said.
“The voters of California did not vote for Proposition 71 so that biomedical companies get a windfall of billions of tax dollars with little or no accountability,” Runner said. “It’s critical that we establish the highest ethical conflict of interest standards, true operating transparency, and a direct benefit to Californians from their $6 billion investment.”
Proposition 71, the California Stem Cell Research and Cures Act, provides $3 billion in general obligation bonds to fund stem cell research and research facilities in California. The act established the California Institute for Regenerative Medicine, led by the Independent Citizen’s Oversight Committee (ICOC), to award grants and loans for stem cell research and research facilities.
Under the Ortiz-Runner constitutional amendment, employees of the Institute, the ICOC and members of the working or advisory groups will be subject to conflict-of-interest and financial disclosure requirements similar to those that govern California public officials and individuals serving or employed by the National Institute of Health. The legislation also will require that all meetings and records are subject to state open meeting and public record laws.
The measure will include strict guidelines to ensure clinical treatments, products or services resulting from the biomedical research are made available to California citizens and public health programs at affordable
costs. It also will require that all financial arrangements ensure the state recoups legal and administrative costs and a share of royalties or licensing revenues derived from the development of clinical treatments, products or services.
Ortiz and Runner also will jointly author legislation to provide for a three-year moratorium on multiple donations of eggs solely for research purposes. That bill will expressly prohibit payment in excess of reimbursement and require providers of fertility treatment services to give patients timely and appropriate information so they may make informed choices regarding the disposition of any human eggs remaining after fertility treatment. Fertility treatment providers also will be required to provide standard disclosures of medical risks, developed by the Department of Health Services, to women considering undergoing fertility treatment.
A second bill will require the State Auditor to conduct periodic financial and program audits of the ICOC and the Institute.
Because of provisions in Proposition 71, the Legislature may only make changes “in furtherance of” the initiative by receiving approval from voters. Legislative constitutional amendments require two-thirds majority approval from both the Assembly and the Senate to qualify for the ballot.
The Senators believe the provisions dealing with egg donations, patient protections and audits are “supplemental to” Proposition 71, and can be enacted by a simple majority vote of the Legislature.
“These measures will uphold our promise to the public that Proposition 71 is implemented in an open, thoughtful and deliberative manner,” Ortiz said. “We owe this public accountability to millions of Americans afflicted by conditions that may some day be cured through stem cell research, and to the taxpayers of California who are funding this critical research.”
# # #
Statement by Robert Klein, Chair
Ed Penhoet, Vice Chair
Independent Citizens’ Oversight Committee
For the California Institute for Regenerative Medicine
Regarding the News Conference Today in Sacramento by
State Senators Deborah Ortiz and George Runner
Wednesday, March 16, 2005
Emeryville, CA – Robert Klein and Ed Penhoet, Chair and Vice Chair, respectively, of the Independent Citizens’Oversight Committee for the California Institute for Regenerative Medicine, made the following statement regarding today’s news conference in Sacramento by State Senators Deborah Ortiz and George Runner:
“First of all, we want to acknowledge and express our appreciation to Senator Ortiz for her leadership in the area of stem cell research in Sacramento and throughout the State of California.
Senator Ortiz and the California Institute for Regenerative Medicine share the same goal: to support stem cell research and to ensure that California leads the way for finding cures for people with disease, illness and injury.
60 % of California voters cast their ballots last Fall, and more than 70 patient and disease advocacy groups, and medical, research and scientific organizations affirmed their hope in the promise of stem cell cures. Their votes were not only an expression of hope, but also a vote of confidence that the Prop. 71 initiative contains sufficient governance, oversight and accountability mechanisms to address the very same issues Senators Ortiz and Runner discussed today.
The initiative anticipated and the Institute is structured to provide significant conflict of interest regulations AND medical and ethical standards, especially those that protect women, based upon recognized and respected standards adopted by the National Institutes of Health. Those regulations and standards are in process of being developed by the Institute’s governing board, the ICOC, its subcommittees and working groups. The public and all interested parties have been, will be – and should be – active participants in this process. In addition, the National Academies of Sciences and Medicine are currently in the process of developing model medical and ethical standards for stem cell research – specifically to meet California’s timeline -- which are due public in April and shall be taken into full consideration by the Institute and the public in the coming months. And, it is important to note, that there are federal regulations already in place that will apply to future research conducted with Prop 71 grants to ensure the appropriate protections for all patients.
In the short few months that this Institute has been in place, we have made significant progress towards setting appropriate and necessary conflict of interest rules for staff. The ICOC is committed to adopting stringent conflict of interest policies and medical and ethical standards – with input from the public. In fact, we have now held 13 open public meetings in just 13 weeks.
We welcome Senator Ortiz, Senator Runner and their colleagues’ participation in this ongoing process, and we look forward to collaborating together with members of the Legislature and the public in this important endeavor.
At the time same time, the voters of California sent a clear message: they entrusted the Institute’s governing board, which is comprised of 29 prominent Californians -- leaders in academia, science, medicine, research, patient advocacy and business -- to move forward with the work ahead. This Board is dedicated to addressing all and more of the issues addressed by Senators Ortiz and Runner today.”
# # #
Critics of Proposition 71 Welcome Reform ProposalCenter for Genetics and Society, Pro-Choice Alliance for Responsible Research support proposal by Sens. Ortiz and Runner
SACRAMENTO – Public interest critics of California’s new stem cell institute, which was created by Proposition 71, welcomed a reform proposal announced today by Senators Deborah Ortiz and George Runner.
“The voters of California passed Proposition 71 based on promises of widely available cures, high ethical standards, and public accountability. They did not vote for throwing out laws that prevent secret meetings and guard against conflicts of interest,” said Marcy Darnovsky, associate executive director of the Center for Genetics and Society.
“We’re glad to see the Senators stepping up to protect Californians, who are the investors in this multi-billion dollar experiment.”
The Center for Genetics and Society and the Pro-choice Alliance for Responsible Research – who both support embryonic stem cell research but were prominent critics of Proposition 71 both before and after the recent campaign – expressed their support and optimism for the proposal’s passage.
“The Ortiz-Runner proposal will bring the public accountability and openness that the authors of Proposition 71 deliberately left out,” added Susan Berke Fogel, director of the Pro-Choice Alliance for Responsible Research. A moratorium on multiple egg extraction is critical to protect women’s health, as long-term effects of the drugs used are yet not known.”
The legislators’ announcement follows last week’s joint informational hearing on implementation of Proposition 71, chaired by Senator Ortiz and Assemblymember Wilma Chan. The hearing addressed many of the issues that have been raised by public interest critics, including conflicts of interest, open meetings, egg extraction, diversity in employment and hiring, health disparities, and financial returns to California.
“I hope that the leadership of the Institute realizes that this proposal will strengthen – not hinder – their work,” said Jesse Reynolds, program director at the Center for Genetics and Society. “The Institute must retain the confidence of the voters to be effective.”For more information, see http://www.genetics-and-society.org/policies/california/ .
Wednesday, March 16, 2005
Odd Couple Tightens Oversight Efforts.
His story began: "Two state senators with opposite views on stem cell research forged an odd political alliance Wednesday when they introduced a proposed constitutional amendment to 'reform' the new $3 billion California Institute for Regenerative Medicine, which is already facing two lawsuits seeking to put it out of business.
Sens. Deborah Ortiz, D-Sacramento, and George Runner, R-Lancaster, also introduced legislation banning for three years so-called 'multiple egg donations' from women who voluntarily submit to hormone injections to 'superovulate' in the name of research. If passed, that law would effectively prevent the agency from funding human cloning projects for medical research for three years."
The agency issued a statement a few minutes ago that said in part, "The initiative anticipated and the Institute is structured to provide significant conflict of interest regulations AND medical and ethical standards, especially those that protect women...."
"We welcome Senator Ortiz, Senator Runner and their colleagues’ participation in this ongoing process, and we look forward to collaborating together with members of the Legislature and the public in this important endeavor.
"At the time same time, the voters of California sent a clear message: they entrusted the Institute’s governing board, which is comprised of 29 prominent Californians -- leaders in academia, science, medicine, research, patient advocacy and business -- to move forward with the work ahead. This Board is dedicated to addressing all and more of the issues addressed by Senators Ortiz and Runner today.”
The legislative move, however, is certainly not good news for CIRM. We will have more on this subject Thursday morning.
The Lowering of Expectations
According to reporter Laura Mecoy of The Sacramento Bee, “The state probably won't issue its first stem cell grants until the fall, nearly four months after its initial plans to begin giving out money in May, the program's interim president said Tuesday.
“In a conference call with reporters, Zach Hall said the May deadline was an 'early hope' that didn't include the time needed to adopt grant guidelines and appoint a committee to review the grant applications.” Mecoy wrote.
Megan Garvey of the Los Angeles Times emphasized another angle having to do with the need to create regional stem cell research facilities. That tied into UCLA's announcement it will spend $20 million creating a new stem cell research facility.
Roiling Undercurrents on Klein
“Meglomaniac and liar” are a couple of the terms bandied about. These do not come from some disgruntled job seeker.
According to one source, “Legislators who have had any contact with Klein generally believe Klein is ICOC's (stem cell agency oversight committee) own worst enemy. He has driven everyone here nuts.
“He's spent the last couple of weeks visiting every legislator and legislative leader trying to get them” to call off last week's hearing into the agency.
“The feeling under the dome is the guy's a megalomaniac and a liar. No one agreed with his request to call off the hearing.
“If anything, it only made them mistrust him more and raised concerns about what is going on over there behind closed doors.”
Apparently that is what led to more aggressive than normal questioning of the interim president of the agency, Zach Hall, by members of the unusual legislative panel. Klein was absent and sent Hall.
Klein's behind-the-scenes lobbying came after he publicly stated he was willing to cooperate with legislators. It also came at the same time, that his allied nonprofit organization, Cures for California, sent out emails across the country to generate pressure on the legislature. The messages solicited recipients (presumably disease sufferers) to send emails to the Legislature or call seeking postponement of the legislative hearing.
The email said, “The hearing will inevitably generate press which could be damaging to the efforts of the Institute, and could impede their incredibly important work. The patient community needs your help!”
“Please mobilize within the next 12 hours!” the email exclaimed.
However, Klein earned good marks for having Hall testify at the hearing. “Congenial” was one word describing Hall although he did not ease all concerns.
In another way Hall was also a plus. “The less ICOC and the Institute are associated with Bob Klein, the better the public's confidence will be in their implementation of Prop 71,” a Capitol source said.
Tuesday, March 15, 2005
Robert Klein: The Missing Man
In response to an inquiry from the California Stem Cell Report, the office of Sen. Deborah Ortiz, D-Sacramento, said she encouraged Klein, who is chairman of the state stem cell agency, to appear. She assured him that his concerns about legal questions and litigation involving the California Institute for Regenerative Medicine could be overcome.
Ortiz, chair of the Senate Health Committee, “encouraged Mr. Klein to view the hearing as an opportunity to inform legislators and the public about the great strides the ICOC is making in this very difficult project: building the world's premier stem cell research institute from the ground up,” her office said.
“She assured Mr. Klein that she would instruct all witnesses and legislators to avoid discussing any issues that were pending before the court. She also encouraged Mr. Klein to attend the hearing with his attorney, who could advise him if there were any points that the attorney believed could jeopardize the litigation pending before the Supreme Court.
“Sen. Ortiz very strongly supports and campaigned for Proposition 71. She hopes the Attorney General is successful in his attempts to have the California Supreme Court take jurisdiction over the constitutional challenges that have been filed and resolve them quickly so that the implementation of this important research can begin and the cures we all hope will come from this significant public investment will be developed.”
The California Stem Cell Report's bottom line: State agencies are sued regularly. Their department heads, however, manage to come before legislative committees when requested. Is Klein different? The worst part about this is that his actions do not benefit the stem cell agency. As we pointed out previously, there is small profit in stiffing the legislature.
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We welcome and will publish comments on the stem cell agency or the failings of this blog. Please send them to djensen@californiastemcellreport.blogspot.com.
Monday, March 14, 2005
California Stem Cell 101 -- Must Reading
It is an excellent background paper prepared for last week's legislative hearing into the California Institute for Regenerative Medicine. It explains the ongoing issues in a straight-forward and evenhanded manner and is must reading for anyone who wants a clear overview of the agency.
The report also included questions that could be addressed by the agency.
They include:
“Whether pegging salaries for ICOC and Institute staff to the University of California and private research institutes is a reasonable guideline and whether the size and prestige of Proposition 71’s research program may enable the ICOC and Institute to attract top scientific and administrative talent without paying the highest salaries.”
“In cases where deliberations of the ICOC and its working groups are conducted in closed session, what record of decisionmaking will be accessible to the public to enable public participation in decisions of the ICOC and its working groups.”
“Whether the ICOC should apply recently adopted NIH standards prohibiting ownership of biotechnology and pharmaceutical company by senior employees to employees of the ICOC and the Institute."
“Whether statements of economic and other interests completed by Proposition 71 working group members should be accessible to the public, as are Form 700s under the Political Reform Act.”
The full text of the background paper follows in a separate item below. It did not carry the name of its author, although normally such documents are prepared by legislative committee staff.