News bites & rumors on human embryo genetic modification

crispr of human embryos
Crispr gene editing can be applied to human embryos. NIH Image.

A lot has happened in the week since the first human embryo genetic modification paper was published by a team led by Junjiu Huang.

There have been a number of new events just in the last few days.

Jocelyn Kaiser over at SCIENCEINSIDER has a new piece reporting a couple important developments including that the journal that published the human embryo editing paper, Protein & Cell, has issued an editorial explaining the review process for the paper. They argue that the review was fast, but appropriate:

“Due to the scientific value and ethical dispute of this study, we not only conducted scientific peer-review, but also consulted related publishing and ethical experts,” wrote Rao, a structural biologist at Nankai University in Tianjin, in an e-mail to Science. “The authors also revised the manuscript based on our suggestions,” he added. He explains that the journal typically reviews submitted papers within 2 weeks, but for significant work they expedite the process. (A Springer representative tells Nature News that review went quickly in part because Huang and his colleagues also submitted the peer-review comments provided to them by Nature and Science and had revised the paper with them in mind.)”

Kaiser also reports that the Society for Developmental Biology has called for a moratorium on any editing of human embryos including in vitro. From the statement:

“SDB supports a voluntary moratorium by members of the scientific community on all manipulation of preimplantation human embryos by genome editing. Such studies raise deep ethical concerns on their own, and in addition could lead to unanticipated consequences if manipulated embryos were implanted into a womb and allowed to develop to term.”

NIH has now issued a statement as well on human embryo genetic modification reiterating that no NIH funding can be used for this kind of work. In addition they remind us that the FDA would have regulatory authority over any attempt to clinically use human genetic modification technology. I’m not so convinced that the FDA could or would do much proactively or even reactively about rogue attempts to make GM people frankly, unless some political pressure came to bear. Note that the NIH also included a nifty CRISPR graphic in the post on their statement that I have pasted above.

The concern over human modification and the potential for designer babies in the future from this kind of technology is gradually entering the public consciousness. Eric Schadt of the Icahn Institute was interviewed on a segment on CBS This Morning on these concerns. I have to say it was a very strange interview with the hosts peppering him with mostly positive-biased questions about what this technology might do if used in actual people and very little discussion of risks.

What’s going on behind the scenes with human embryo genetic modification? Things are still pretty murky out there with many rumors out there. There seems to be a consensus amongst rumors, for whatever it is worth, that at least one more paper will be published this year from another team in China and probably more than one, probably not in top impact journals. Another bit of chatter is that a future paper will have American authors on it even if the actual embryo editing did not occur in the US, although others think that a paper from a team in the US could be in the works.

I don’t know if it is connected to the sense of tension over possible future attempts at clinical germline human genetic modification, but concerns over the potential for attempts at human reproductive cloning are also bouncing around presently. Both cases highlight emerging possibly quick difficult dual use dilemmas in the life sciences.

8 thoughts on “News bites & rumors on human embryo genetic modification”

  1. @Frederick,
    You raise some great points and ask some tough, but good questions. My feeling is that a line has been crossed and there may be no going back in terms of realistically hoping that all folks hold back on going too far on editing of human embryos. I suppose another question at this point — what can we actually do at this point that would be constructive or helpful?
    Paul

  2. @Nick,
    Thanks for the additional thoughts and comments. I would be interested in your writing on how to define, think about, etc. dual use.
    I guess I lean towards human germline modification being a potential dual use issue or posing dual use dilemmas, but I’m totally open to other ways of framing this or defining it. I also get your points on this.
    Paul

  3. I just read the “statement” you referenced, regarding NIH funding of research using gene-editing technologies in human embryos. Part of Francis Collins’ justification is that such research (viz., altering the human germline in embryos for clinical purposes”) “has been viewed almost universally as a line that should not be crossed”. Seems to me the line has been crossed. Correct me if I’m wrong. It was only a few short weeks ago that I was reading about calls for a mandatory moratorium on such research. Was this limited to the US scientific community? How can such a moratorium be enforced? Clearly peer pressure alone won’t do the job.

  4. That is a lot to digest. I’m a clinical embryologist. My concern is that once the genie is out of the bottle, there ain’t not putting it back. Pandora’s box also comes to mind. I have worked in the field of human IVF (ART) for over 30 years. I’ve seen first hand the use, and misuse of powerful technologies that capture the public’s attention. On occasion, the FDA has stepped in and tightened the “rules”, e.g. African Green Monkey derived cells for cell co-culture. Much like the premature introduction of stem cell therapy by those who seek to capitalize on the hopes of patients’ suffering, I can foresee gene editing occupying a similar niche in the arena of ART. This certainly appears to me to open the door to “designer babies” just a little more.

  5. Paul,

    I think there are absolutely different definitions of dual-use! In particular, not all dual-use research that is concerning is necessarily Dual Use Research of Concern in the sense of the USG policy term.

    It’s an interesting concept—whether, and when, recklessness constitutes dual-use. I’ve got a chapter in my current book project where I tackle the question. If you are interested, I’d love to send it to you, as I make a couple of distinctions. I, personally, absolutely think that recklessness could be captured in a taxonomy of dual-use. That is, there are some kinds of uses of research and technology that are so manifestly reckless that to do them would likely be considered morally reprehensible. In those cases, intent doesn’t matter so much as the user’s intention is delusional (i.e. they think something is going to result in something good happening, but they actually have no real reason to think this is the case).

    Are in vitro (or, heaven forfend, in vivo) germline studies involving viable human embryos of this kind? Maybe. And so there might be an idea of “dual-use” you’re aiming for in which one set of uses are (for example) those that would be permitted under your ABCD framework, and the others are jumping straight to viable embryos. There we’ve got two possible uses of the current technology, one good and one bad.

    I’m not sure, however, that this would be clearly understood as dual-use in the same sense as cases involving (for example) bioweapons, because the above don’t seem as robustly bad. As the science improves, the options change. Bioweapons rarely, if ever, use their badness—anthrax is still bad 14 years after 9/11.

    There’s also an issue of magnitude and ease of use of the “bad uses,” and here I think the recklessness/intent issue comes apart from questions of magnitude. The current bad uses don’t seem to involve huge magnitudes—though they involve serious ethical issues on a small scale. A heritable, stable germline intervention could be bad, but again, magnitudes seem different here *temporally* than in others, at least relative to the good you could do.

    And Eugenics is *tricky.* It never really went away, and as a movement it covers a huge amount. PGD is, or could be, Eugenics. IVF. Hell, education, and nutrition. The point is, I don’t think that a “new eugenics” necessarily fits the mold of the old Eugenics. That’s a more complicated issue, and calculating the marginal harms of germline interventions to a Eugenics movement, relative to everything else, is really difficult. (That’s informed a lot by my doctoral supervisor: http://link.springer.com/article/10.1007%2FBF03351241)

    At the end of that, I’m not sure it is strictly an example of a moral *dilemma.* I don’t see that people’s obligations are pulling them in mutually exclusive directions. This seems more about which order we do experiments in. In those cases, the better historical episode in bioethics might be the development of clinical trial protocols, or the rDNA movement. Perhaps narrowing things to particular “experiments of concern” would also help clarify these issues a bit.

    In terms of dual-use, this conversation reminds me a bit of conversations about synthetic biology. Dual-use is difficult to apply to a methodology, because it is hard to parse how “use” works from a particular causal locus—with a single experiment, there’s a point of origin to draw one’s “uses” back to. I’ve recently published a paper on how one might think about dual-use methodologies, however, so maybe we can carve out some tighter distinctions through that. http://link.springer.com/article/10.1007/s40592-015-0026-y/fulltext.html

  6. Hey Paul. I agree there are some risks involved with CRISPR/Cas9 technology. I don’t, however, see the dual-use dilemma. Typically, dual-use (in the contemporary, nonmilitary sense) is characterized as the potential for a) some application that aims to create some benefit, and b) an application that aims to create some harm. The focus is also typically on harmful and beneficial applications on population-level scales.

    While I see risks for both clinical germline intervention and human reproductive cloning as *risky* in the current state, I don’t see them as “applications that aim to create some harm.” The negative outcomes that arise from those technologies, presumably, arise because the application fails to achieve its goals. The application might be reckless, but it isn’t harmful as an application in the same way as, say, taking virology research and applying it to biological weapons.

    It is also worth noting that while current debates about GOF research have a history in debates about dual-use (from 2011-2012), they for the most part aren’t currently about the dual-use status of the research. Rather, they are about the risks and benefits attendant to individual experiments. One act, two (or more) possible outcomes; not one piece of research or technology, two different acts.

    I think you’ll need to do more work to show why this is a dual-use dilemma. It seems that if the technology is approached prudently approached, the benefits are largely positive. There may be some case to believe that there could be harmful uses of this technology—you’d be the expert on that, but I’m envisioning intentionally (and efficaciously) introducing some novel and harmful mutation into the human germ line—but it doesn’t seem that the conversation just now, or your post, is about that.

    I think a bigger lesson for CRISPR to draw on from dual-use is how to—or more how not to—arrange ethico-scientific deliberation. We don’t need another NSABB.

    1. Hi Nick,
      Thanks for the great comment!
      Perhaps there are or can be different views on what “dual use” means?
      My understanding as a non-ethicist was that there does not have to be intent for a technology to be used in a harmful way, but only potential for harm. It’s an important distinction and perhaps you know better whether it applies or not to “dual use”. However, here (http://www.bu.edu/orc/initiatives/durc/) it sure seems like an intent or “aim” to harm via a technology is not absolutely required:

      “The National Science Advisory Board for Biosecurity (NSABB) has defined dual use research of concern (DURC) as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or materiel.”

      Or maybe intent is a key part of dual-use?

      The misapplication of human genetic modification technology could do great harm on an individual level by creating humans that have introduced aberrant genetic changes and associated technology-caused disease states. On another level such harm then goes beyond an individual to society as such introduced mutations would be heritable and probably difficult or even impossible to correct. Some might also view human genetic modification for non-therapeutic, enhancement purposes that unintentionally promote Eugenics-like environments as gravely harmful. Furthermore, it is not difficult to imagine given historical examples that specific individuals or organizations may deliberately use human genetic modification technology specifically and intentionally for Eugenic purposes. In that context it sure sounds like a dual-use dilemma to me with intent to harm even if the eugenicists may not think of Eugenics as harmful.

      Thoughts?

      Paul

  7. OK Paul, I’m going to say some stuff that cell biologists will see as trivial. But it’s not trivial to us tag-alongs. Others will see it as downright deflating. But if my premise is correct, so be it.

    The sexual reproduction game has an interesting feature that dummies (like me) find a little surprising. We have this notion that our children are genetically “half of us” and so that in some small way we persist through the following generations and time.

    It’s just not true. Even though we may have many distant descendants, it is quite possible that NONE of those descendants will have ANY of our genes! I wonder how many people understand this?

    Understanding this fact shows just how pointless (and vain) it is to go to extreme lengths to reproduce using expensive and potentially risky technologies (like gene editing and 3-person IVF). I add, that taking a risk on ones own behalf is acceptable — but taking a risk on behalf of someone else (your child) is where I draw an ethical line in the sand…

    Cloning, of course, perpetuates the genes. The ultimate form of nepotism! Thus cloning is the exception by which genes are truly preserved through generations. But this only applies so long as those generations stick to the business of LOVING THEMSELVES TO THE EXCLUSION OF ALL OF THE REST OF HUMANITY.

    Thus, my objection is not with regard to efficacy. My objection is not with regard to ethics. My objection is for the sake of true, unadulterated love.

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