Prop. 14 News Coverage: Campaign Chicken Feed and Editorials

The Biopolitical Times this week briefly explored campaign spending on Proposition 14, newspaper editorials and opposition to the $5.5 billion stem cell research measure on this fall's California ballot.

The piece by Pete Shanks, who has followed the state stem cell agency for a number of years and opposes the measure, called the $18 million spent on behalf of Proposition 14 "almost modest." It is actually chicken feed compared to the more than $700 million spent so far on California on all ballot propositions.

Indeed, the $18 million is smaller than many grants from California's stem cell agency, which would be refinanced and significantly expanded under Proposition 14. A substantial number of the agency's grants run about $20 million. 

Several years ago, Robert Klein, the Palo Alto real estate developer heading the campaign, told the California Stem Cell Report that the effort would cost $50 million. However, the more modest $18 million may be the product of a difficult fundraising environment this year rather than reflecting what is needed to win approval of the measure. Or it could be a lack of enthusiasm among potential major donors.  

Known officially as the California Institute for Regenerative Medicine (CIRM), the agency is scheduled to begin closing its doors this winter without a substantial infusion of cash.

Shanks also tallied up newspaper editorials on Proposition 14 and said, "Overall, the  'NO' publications seem far more impressive." Many of the major newspapers in the state oppose the measure, including the Los Angeles Times, the state's largest circulation newspaper. The San Francisco Chronicle, which spent months in 2018 analyzing the operations of the stem cell agency, also opposed Proposition 14. 

Shanks noted that Zach Hall, the first president of the agency, says the agency has served its purpose and no longer is needed. The California Stem Cell Report on Monday first reported Hall's position. 

The Biopolitical Times is produced by the Center for Genetics and Society in Berkeley, Ca., which opposed creation of the stem cell agency in 2004.  

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Read all about California's stem cell agency, including Proposition 14,  in David Jensen's new book. Download it from Amazon:  California's Great Stem Cell Experiment: Inside a $3 Billion Search for Stem Cell Cures. Click here for more information on the author.

A Harsher Look at California's Stem Cell Program: No More Cash Without Changes

California's $3 billion stem cell experiment received a host of accolades last week at a state legislative hearing, but one strong, critical voice was not heard in the proceedings.

That came from the Biopolitical Times, a blog operated by the Center for Genetics and Society of Berkeley, a longtime foe of the agency. 

In a piece written by Pete Shanks, the agency was taken to task for a number of reasons. And he argued that it should not receive additional funds as it is presently constituted.

Shanks wrote, 

"At one time, CIRM had a deserved reputation for funding buildings , some of them at private universities, and was heavily criticized for that, but the $270 million “major facilities” budget approved in 2008 has all been spent. Some of the conflict of interest scandals are largely in the past, though ripples persist , and some of the institutional ones remain; several universities that receive large grants are still represented on the board . But there has been a new regime in place (“CIRM 2.0”) for several years.

"Things have improved, though not enough."

Shanks noted that the agency has failed to finance any therapies that are available for widespread use. He noted that the interest expense on state bonds that support the agency boost the cost to taxpayers to $6 billion from the $3 billion in awards.

He said the hearing last week was largely "a promotional vehicle." (Shanks' piece was published on Aug. 14, the day before the hearing by the Assembly Select Committee on Biotechnology.)

Shanks concluded:

"Going forward, there are two separate questions to consider: Is continued state funding of stem cell research at a rate of roughly half a billion dollars a year the best use of state funds?

"If it is, should those funds be spent through CIRM as it is presently constituted?
Is continued state funding of stem cell research at a rate of roughly half a billion dollars a year the best use of state funds? If it is, should those funds be spent through CIRM as it is presently constituted? 

"The first question is debatable; the second deserves a flat “No.” There is something obviously wrong when an agency is funded by public money but never has to submit a budget to the legislature, and can even go 13 years without appearing before an oversight committee. Two major reports, in 2009 by the Little Hoover Commission and in 2012 by the then Institute of Medicine (now part of the National Academies of Sciences, Engineering, and Medicine), both concluded that the governance structure of CIRM is seriously flawed."

A Nobel Laureate's 'Unsettling Note' From California's Human Gene Editing Conference

The Center for Genetics and Society, which has been monitoring human gene editing for the past few years, weighed in this week on the possibility that the state of California will beef up its role in financing research involving the sometimes controversial process.

The Berkeley-based center has taken cautionary approach to the field. The article this week on the center’s blog by Marcy Darnovsky, executive director of the group, continued in that vein.

Darnovsky attended the session last week during which the $3 billion California stem cell agency decided to embark on a thorough examination of the topic with the possibility of moving forward on gene editing of human embryos, a field that the federal government does not fund.

Darnovsky provided a summary of the session and cited “an unsettling (if unsurprising) note” from David Baltimore. He is a Nobel Laureate, former president of Caltech and a former member of the governing board of the California Institute for Regenerative Medicine(CIRM), as the stem cell agency is formally known. Baltimore also has been active in sounding go-slow recommendations on human embryo modification.

The concluding paragraph in Darnovsky piece said, however,

“Finally, an unsettling (if unsurprising) note about David Baltimore, who has played an influential role in the current controversy about germline gene editing and who chaired the organizing committee for last December’s International Summit. In previous comments about human gene editing, Baltimore has talked about responsible science; at the CIRM meeting, he came out explicitly in support of human germline modification. In his invited presentation, he said – as if this were a matter of scientific fact – that the desire for biologically related children is genetically hard-wired. He acknowledged that people at risk of transmitting genetic disease can already almost always have unaffected children in a variety of ways, and that therefore germline gene editing would at best benefit very few. But, he continued, ‘there are circumstances where it is the only opportunity for doing what a patient wants....To me, that’s sufficient reason to bring it to clinical use.’"

Darnovsky’s article also discussed testimony by Charis Thompson of UC Berkeley, who raised a number of policy issues.

Darnovsky wrote that they included “reminders that CIRM is mandated to serve not only patients with unmet medical needs, but also the taxpayers and voters of California; that disability justice experts as well as patient advocates should be consulted about gene editing directions; that CIRM should ensure that the work it funds does not exacerbate health disparities; and that if evidence of health disparities or eugenic trends emerges,’real consequences’ must ensue. She concluded by saying that ‘It is not `anti-science’ to note that historically, slopes are indeed slippery,” and that “California deserves – and can have – both the best science and the best ethics.’”

Darnovsky additionally reported on comments by Jeff Sheehy, a member of the CIRM board. She wrote that Sheehy was concerned that the agency might “have little recourse if grantees used other funds to initiate a pregnancy. ‘Where does our reach start and end?,’ he asked. ‘Does it start at the purpose of the proposed research? Do we just say you can’t implant?’ Sheehy suggested that if CIRM approves any grants for research that would produce modified human embryos, it include as a contractual requirement that those embryos cannot be used to initiate a pregnancy, whatever the funding source for that final (and trivial) step.”

CGS: Broader Perspective Needed in IOM-CIRM Performance Evaluation

The Center for Genetics and Society has filed a brief statement with the Institute of Medicine panel examining the performance of the California stem cell agency, expressing the hope that the inquiry will include "a broader range of sources."

Marcy Darnovsky, associate executive director of the Berkeley group, said that "a meaningful review by (the IOM) committee could make an important contribution to needed changes at the agency." Darnovsky's organization has followed the stem cell effort since its inception.

She noted that CIRM is "a public agency spending increasingly scarce public resources" and has raised the possibility of seeking another multibillion dollar bond measure from voters.

The IOM inquiry has finished half of its public process and is yet to hear an independent analysis of the stem cell agency, which is paying $700,000 for the study.

Earlier Darnovsky told the California Stem Cell Report that the Institute of Medicine has not contacted her organization for comments, although she has spoken with the public relations person for the IOM.

Here is the text of Darnovsky's statement sent to the IOM.

"The Center for Genetics and Society is a public interest organization working to ensure responsible uses and effective societal governance of human genetic and reproductive technologies.  We support embryonic stem cell research, but have been concerned for some years about a number of aspects of the field, and of the California Institute of Regenerative Medicine in particular.

"We have been closely following CIRM since the campaign for Proposition 71 that established it in 2004. We have attended numerous meetings of the agency’s governing board and Standards Working Group, worked with other public interest groups who share our concerns about CIRM, written frequently about CIRM in our publications, and been cited dozens of times in articles about CIRM in key state and national news outlets.

"In 2006, we published The California Stem Cell Program at One Year: A Progress Report, which assessed CIRM's performance to that date and offered recommendations. See http://www.geneticsandsociety.org/downloads/200601report.pdf

"In 2008, CGS policy analyst Jesse Reynolds gave invited testimony to the Little Hoover Commission’s hearing on CIRM. See http://www.geneticsandsociety.org/article.php?id=4386

"We are encouraged that the Institute of Medicine is undertaking an independent assessment of CIRM, though we hope that you will invite input from a broader range of sources than were represented at the meeting last month in San Francisco. With key questions about the future of CIRM unresolved, and its leadership contemplating a campaign for another bond measure.

"As I wrote in a recent commentary that expressed our disappointment with the roster of speakers at last month’s hearing,

"Ballot measure or no ballot measure, CIRM will continue to disperse the public money it controls – another billion and a half dollars. This is a public agency spending increasingly scarce public resources. It is funding a field of research in which we place great hopes for medical and scientific advances. These factors make it all the more crucial that CIRM follow the basics of good governance and public accountability, and eschew the hyperbole and exaggerated promises that have tainted stem cell research for so long.

"See  http://www.geneticsandsociety.org/article.php?id=6045

"Please let us know if we can be of help. We would be very glad to share our insights and recommendations."

The California Poster Child, Stem Cell Wars and Proverbial Church Picnics

Are states running amok with embryonic stem cell research? Should or can the federal government reassert its control? Can workable compromises be found?

Richard Hayes, executive director of the Center for Genetics and Society in Oakland, Ca., addresses these issues in a piece on Bioethics Forum, which is sponsored by the Hastings Center Report.

Hayes writes about the "sorry" state of the stem cell debate:

"This polarized politics has given us the worst of all possible worlds: a policy stalemate at the federal level accompanied by a plethora of state-level stem cell funding programs lacking the sort of planning, ethical oversight, and regulation that biomedical research of such consequence requires. California's $3 billion stem cell program is the poster child of this predicament. Since its inception in 2004 it has been under fire for conflicts of interest, inadequate concern for the health and safety of women who provide eggs for stem cell research, unrepresentative policy-making bodies, and misplaced research priorities.

"These flawed state programs are setting the stage for even greater problems to come. Technologies now under development, including pre-implantation genetic diagnosis for both medical conditions and cosmetic traits, somatic genetic enhancement, and inheritable genetic modification, promise to make the stem cell wars look like the proverbial church picnic.

"If these technologies are embraced by the largely unaccountable infrastructure now being established to support stem cell research, they will be difficult to constrain. Once developed and made commercially available, they would be used disproportionately by the most privileged, and become new and powerful drivers of inequality and exclusion.

"The tragedy of this situation is that public opinion surveys consistently show that a strong majority of Americans support a morally serious middle ground regarding the new human genetic technologies. Americans are not irrevocably opposed to research involving the destruction of human embryos, but they want to make sure it is done only after alternatives have been exhausted, and with effective structures of public oversight in place. Americans want cures for diseases, but few are willing to turn the genetic future of the human species over to dismissively arrogant scientists and profit-hungry biotech boosters. Unfortunately, no organized constituencies with influence comparable to that of the religious conservatives or the research/patient/bioindustrial community exist to represent this majoritarian position in the political arena."

Hayes finds some hope in the approach detailed in "Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies," by Francis Fukuyama and Franco Furger. Hayes said the book "could serve as a rallying point for those desiring an end to the current counterproductive policy stalemate."

Hayes called the book "the most comprehensive analysis of human biotech regulatory policy yet published in the United States. With the 2008 congressional and presidential campaigns now moving into high gear, the report comes at an opportune time. "Beyond Bioethics" should be studied carefully by everyone interested in working towards human biotech policies that can be supported by the great majority of Americans."