California’s Stem Cell Agency Considers “Editing” Human Embryos

Posted by Marcy Darnovsky on February 9th, 2016

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A committee of California’s state stem cell agency met on February 4 to consider whether it should fund genetic editing of human embryos, and if so, whether such experiments require any change of its rules or regulations.

Back in 2004, 59% of Californians voted to allocate $3 billion of public money to establish the California Institute for Regenerative Medicine (CIRM), persuaded by promises that stem cell-based cures were imminent, and by frustration about the Bush administration’s restrictions on federal funding of techniques that destroyed human embryos. Now, as CIRM considers whether to underwrite research involving the genetic modification of human embryos, decisions at the federal level are again playing a role. National Institutes of Health director Francis Collins said in April 2015 that it won’t fund such research because “altering the human germline in embryos for clinical purposes….has been viewed almost universally as a line that should not be crossed.”

CIRM’s mandate to support research that can’t be federally funded was mentioned several times during the February 4 Standards Working Group meeting. According to CIRM staffer Geoff Lomax, current agency regulations allow research using human embryos, but prohibit their reproductive use. Much of the discussion at the meeting focused on identifying questions that new gene editing techniques raise about the conduct of such research. The resulting list of issues includes whether the research should be funded at all, and if so, how the use of modified embryos to initiate a pregnancy could be prevented. New considerations about informed consent from people donating gametes and embryos for research were also raised. As a next step, a subcommittee will examine the identified issues and draft recommendations that the Standards Working Group will consider and then pass on to CIRM’s governing board.

The meeting was live-streamed, but the audio quality was so poor that remote participation was quite challenging. David Jensen’s California Stem Cell Report coverage of the meeting here and here includes the complete list of identified questions as provided by CIRM. An account by Kevin McCormack, CIRM's Senior Director of Public Communications and Patient Advocate Outreach, can be found here. And writing at Stat, Charles Piller put CIRM’s deliberations in a broader policy context.

Having attended the meeting, three points stand out for me as takeaways:

  • On the final panel of the day, Charis Thompson raised key issues about CIRM’s ethical and social responsibilities. Her invited presentation 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.”
  • Jeff Sheehy, a member of both the Standards Working Group and CIRM’s governing board, is quite concerned about the following prospect: CIRM might decide to fund research involving the genetic modification of human embryos but then 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.  
  • 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."

Composite image via CIRM and National Academies.

Previously on Biopolitical Times:

Posted in Biotech & Pharma, California, Inheritable Genetic Modification, Marcy Darnovsky's Blog Posts, Medical Gene Transfer, Stem Cell Research


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