Wednesday, April 06, 2005

Critics: Conflict Code Not Up to Snuff

The proposed conflict of interest code for the Oversight Committee of the California stem cell agency Wednesday drew fire from one of its longstanding critics on the grounds divestment was needed -- not disclosure.

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

The California stem cell agency on Thursday will consider two conflict of interest policies – one for the bosses (the Oversight Committee) and one for their employees, which some might argue is tougher than the one for the bosses.

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

The California stem cell agency has a new science director – Arlene Chiu.

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

If you want to take a look at some of the substance of the discussions that will occur at Thursday's meeting of the Oversight Committee, go to the CIRM website.

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

Last month the California stem cell agency found itself in something of a debacle concerning the search for its permanent president.

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 type of expenses of human egg donors are appropriate to be reimbursed? Lost wages? Travel expenses?

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

While we are on subject of such issues as egg production, reporter Sandy Kleffman of the Contra Costa Times had a good piece on legislative moves to control it.

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

Legislation to tighten controls over the California stem cell agency is scheduled for a hearing April 20 before the California State Senate Health Committee.

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

With only four working days left before the next meeting of the oversight committee of the stem cell agency, Californians remain pretty much in the dark about what is likely to voted on by the panel.

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

On March 30, we incorrectly reported that the oversight committee will meet next Wednesday. The date of the meeting is actually Thursday April 7.

Wednesday, March 30, 2005

Here Comes $3 Billion

The California stem cell agency appears ready to take the first steps towards issuing $3 billion in bonds to finance its efforts to find cures and treatment for everything from cancer to Lou Gehrig's disease.

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

If you haven't seen it already, reporter Laura Mecoy's story on the super ovulation issue and California State Sen. Deborah Ortiz is worth a read.

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

California's stem cell agency is coming under scrutiny in the hallowed halls of UC Berkeley.

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

Chris Nolan, in a column for eWEEK, touches again on the interplay of business and government in relation to the California stem cell agency.

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

Uncertainty is the bane of bonds. Look for the California stem cell agency to move after its April meeting to attempt to ease the impact of the refusal by the state Supreme Court to rule on the legality of the agency.

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.

Wednesday, March 23, 2005

The Fallacy of the Will of the People

More than two-thirds of the people of California don't care about their state's new stem cell agency or oppose it.

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

Reporter Laura Mecoy of The Sacramento Bee looks like she is alone on rejection of every point of the Lee-Halpern petition by Robert Klein, chairman of the California stem cell agency.

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

“Sweetheart deal,” “irrational pandering” by cities, subversion of the people's will – all these and more are part of the freshly flowering cyberspace commentary on California's stem cell agency.

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 Sacramento Bee has editorialized on the current situation with the stem cell agency, suggesting that it move at its April meeting to alleviate legislative concerns.

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

On Friday, we incorrectly stated that Robert Klein worked and lived in San Mateo County. In fact, he works and lives in Santa Clara County, just south of San Mateo.

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