Transcript generated by machine and may contain errors

Dani Pacia Hello, everyone. Welcome to the Hastings Center event toward navigating danger and Promise together editing the human genome. This discussion will focus on the outcomes and next steps from the just concluded third International Summit on Human Genome Editing. Although you will not be audible or visible throughout, we really encourage you to ask questions through the Q&A function on Zoom. This event is being recorded and it will be available later today on the Hastings Center website for viewing with closed captioning and other additional accessibility features. It is now. My pleasure to introduce Josephine Johnston, a senior research scholar at the Hastings Center and a lecturer at the University of Otago in Dunedin, New Zealand.

Josephine Johnston Thank you, Dani. It’s really a great pleasure to be able to bring this panel discussion or this these guests to to this webinar today for the Hastings Center. I’m going to say a little bit in advance about the summit and kind of some of the background leading up to it. And then I will introduce two featured panelists and ask them to share some reflections, and then we’ll move into a discussion and audience Q&A. And as Dani said, is absolutely time and the program for you as an audience member to put a question and for us. So we really look forward to that part of the discussion. So as you know, many people will obviously know this, but just to kind of remind us all a little bit, there have been technologies and tools for editing genomes, for doing genetic engineering around for quite a long time. But in 2012, I much improved technology for doing that, called the CRISPR-Cas9 system was shown to be able to edit pretty much any kind of DNA in any type of cell. And that was a really huge step forward for genome engineering and genome editing. So this technology was based it’s from a bit, it’s bacterial immune system technology, something that bacteria use to fight off viruses. And in 2012, publications showed that it could be used to edit DNA in any kind of cell. And that was immediately obvious that that would be a really helpful tool for use and non-human. And of course, also human cells. It wasn’t, as I say, the first technology to enable genetic engineering, but it was orders of magnitude more efficient and quick overall than existing technologies. And it immediately changed the day to day work of many scientists, mostly in ways that are likely a very little public interest. But it also proposed the possibility of realizing really a dream of human genetics in the Human Genome Project, which was not just to identify genes that cause disease in humans, but to actually be able to alter them in ways that could eradicate genetic disease. So in April 2015, there was a paper in science by 18 scientists and by with this is lead by David Baltimore and featuring Jennifer Doudna, one of the people who discovered CRISPR Cas9 system, identifying the huge potential of the system to enable modification of human genomes. But oh I non-human but also raising a series of ethical issues, what the paper called unknown risks to human health and well-being and among other protections. The paper called for essentially summits of the kind that we have just had. They called for They identified the need to convene a globally representative group of developers and uses of human engineered genome engineering technology and experts in genetics, law and bioethics, as well as members of the scientific community, the public and relevant government agencies and interest groups. So they really code for something just like what happened. And indeed that paper was published in April and already in December 2015 in Washington, D.C., there was the first international summit on human genome editing. Among other things, that summit came out quite forcefully against heritable genome editing, which would be using this technology to make changes that could be passed on in one from one generation to another and humans. So they came out forcefully against it, but were more cautious about non here, more so-called somatic applications. So using the technology and people that already exist to make changes that are not intended to be here inherited. There was, of course, a second summit then in November 2018 in Hong Kong, and that summit was really dominated by news that broke in the days before the summit that a scientist had actually already used a CRISPR technology to edit the genomes of embryos. And then in an attempt to create children who were immune to HIV and that twins and then another child were actually born from those experiments. So that news absolutely dominated that. And many people in the public would have sort of encountered this debate prep for the first time and in the news and the response to this summer and that announcement. So the third and final of the planes, this plane series of summits just took place in March, this March this month in London. And the focus was really on somatic editing. So either saying people who already exist to make changes, to confer or eradicate disease in them or to treat disease, there were also a huge importance in the summit on equity or access concerns. So with these new therapies, how can we make sure that they are available to all who need them in a lot of and some other justice related questions that are attending this? So in order to discuss what just happened and where we might be going. From here and what was missing and what else we should be considering. I’m really fortunate to have Françoise  Baylis and Ben Hilbert here to discuss this. They are two key voices in their genome editing debate, and I’m going to introduce them now and then ask them to each in turn share some of their reflections. So Françoise  Baylis is the author of the book Altered Inheritance, CRISPR and the Effects of Human Genome Editing, which was published in 2019 by Harvard University Press and recently translated into Chinese, which seems very important. She is a distinguished research professor emerita at Dalhousie University in Canada and was a member of the organizing committee for the Genome Editing Summit. She was also a member of the AU’s Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. Those standards were released in 2021, and then J. Benjamin Herbert is the other panelist with us today. He is associate professor in the School of Life Sciences at Arizona State University. He’s trained in science and technology studies at days with a focus on the history of the modern biomedical and life sciences. He does work at intersection of East bioethics and political theory. He has a book published in 2017 called Experiments in Democracy, Human Embryo Research and the Politics of Bioethics, obviously really relevant to this debate. And he’s co-director of the Global Observatory for Genome Editing. To hear a little bit more about, it’s an international group that seeks to expand the range of questions asked at the frontiers of emerging biotechnologies like human genome editing, and bring broader perspectives to bear on that conversation. So I’m going to turn over now to Françoise  and Ben and invite them to share some of their thoughts and we’ll have a little bit of a conversation and then we will move to some of the questions from our audience. So Françoise .

Françoise Baylis Great. Well, first of all, thank you for providing me with an opportunity to share some of my thoughts about what happened at the third International Summit on genome editing. And I guess the first comment that I want to make, which is concerns the focus of the meeting and as you’ve already rightly pointed out, largely the focus was on somatic human genome editing. And I think you saw that clearly in the program. I would say two thirds of the program was really devoted to this. And also I think you saw this in the final statement where the bulk of the comments really have to do with that and with a focus on equity and access. So I think that was a purposeful choice on the part of the planning committee and part of the goal there was, in fact, to try to shift a little bit the conversation. The reason for wanting to shift the conversation is to say that, look, we’re actually moving into clinical trials now and we really need to focus on what are the ethical issues right now for research participants and for patients. So I would say to you, I was also a member of the planning committee for the first international summit in 2015. And I think that where somatic human genome editing was concerned, quite frankly, we gave it a pass. You know, if you go back and you look at that statement, it sort of says, Yeah, we know how to do this kind of research, so that’s okay, let’s just carry on. And then the focus on heritable human genome editing, I’m not persuaded we actually know how to do that kind of research. I think there are some really important questions about trial design, some really important questions about equity and access, which are the ones that this meeting focused on. But it’s just to say, I think we actually need to go back and examine more carefully some of those ethical issues anyhow. So that’s the first comment I want to make. There was a shift. The shift was purposeful. Some people are critical about that shift and I’m happy to take questions and offer more comments on that. The second thing that then that I want to talk about is the other end of the spectrum, the heritable human genome editing. And here for me, it’s really important to, if you will, layer the various statements from the organizing committee. So in 2015, ultimately what you have and I have described this as a two part ethical framework, you have a claim that you can’t move forward with heritable human genome editing unless you meet standards of safety and efficacy and broad societal consensus. I’ve said publicly, isn’t that great? What a simple ethics framework. And then I’ve also said, you know what? It’s actually super complicated. Why? Because we actually don’t even know what those two things mean. And it’s really important to hear that we don’t know what either of them mean. And they’re both value laden. We don’t actually know what the standards of safety and efficacy are or would be. And we ought to interrogate that, you know, safe enough according to whom. And I think then also broad societal consensus. I mean, we put this notion out there and the work that should have been done is to try to unpack that. And instead of unpacking it, quite frankly, my perspective is we’ve had lots of attempts to massage that. So some people instead talk about broad societal debate. Well, that’s very different from broad societal consensus. Right? So debate. Well, how do you know when the debates over I mean, as somebody who’s advocating for broad societal consensus, I know when the consensus would be reached, or at least I have a theory about what that would mean. Anyhow, my point is we have the statement safety and efficacy, broad societal consensus. That’s 2015. As you’ve already said, in 2018, we have the second summit and we have the birth of two babies that are nominally genetically modified. And to me, the interesting thing about that summit is you actually go back and you look at some of the early video. In the early moments, you have David Baltimore and Fang Xiang, at least those two for sure actually citing the 2015 document and saying this is unacceptable, this is irresponsible. You didn’t meet the standards of safety and efficacy and broad societal consensus. And within days that’s disappeared because within days we have the statement from the second summit and it actually calls for a translational pathway forward towards such trials. And I find that actually really to this day, still quite surprising. You actually have this event, which everybody agrees is unacceptable. And your conclusion is, well, we ought to do it better next time. If you look down at the writing or the text for the third international summit, I see that actually as a bit of a pulling back because what you see is a commitment to ongoing discussion and debate about whether we should go forward with this. And I think that that’s important. And I think it’s really important because people like myself and also Ben have been saying, I think loudly, you don’t get to the Howe question, which is where a lot of energy is focused until you’ve answered the weather question. Once you know whether you should go ahead, then you can invest a lot of time in the how to. And I think right now we kind of have the cart before the horse. We have a lot of people investing a lot of time and energy into how to do this without having really wanted to bring open a discussion around that. Two other quick points and then I’ll pass it off to two. Ben. I think there’s a huge issue here around governance, and I don’t think that this was fully addressed at the summit. And I regret that for a variety of reasons. And I think that the thing that’s really important is there seems to be an assumption on the part of some that the only kind of governance we can anticipate in this area is national governments. So governance. So at the country level, countries will decide where to go. And yet at the same time, we talk about the problem of forum shopping and, you know, the ways in which we imagine illegitimate activities taking place. And yet the assumption is we can’t have a treaty, we can’t have international agreements and declaration moratoria. And I understand the reticence on the part of some for that, who see these as, you know, robust entrenched mechanisms. And then we don’t want to embrace that. But I think we should have a conversation about that. And I think there’s lots of reasons to do that, and I hope we can come back to that point in the conversation. My last point and again, this is just putting out thoughts there for people to respond to has to do with language and the language of one and done. I’m going to still reflect on this some more, but I thought it was very interesting up until this point, that phrase one and done, at least in my readings, has mostly focused on heritable human genome editing. And the claim has been why treat individual patients hopefully successfully? They then go on rich reproductive age, they reproduce and they have children with the same genetic disease that they have. Why don’t we do a one and done move to heritable human genome editing? At least that’s an argument that some people advance. And at this summit, I was really struck by the fact that we’re now hearing one and done in the context of somatic human genome editing. So why treat this person with a currently available technology, for example, in the context of sickle cell disease, hydroxyurea and pain management, etc.? What we could do a one and done, which would be the genome editing in a somatic context. So I think for me that was really striking and I want to pay attention to see how that language continues to be used, because if people start talking about just one and done, how is it that others will interpret that? Will they interpret that as a defense of somatic genome editing, or will they interpret that as a defense of heritable human genome editing? So those are my sort of initial thoughts or comments.

Josephine Johnston Thank you. That’s so provocative and interesting. Already getting questions about some of what you said. So that’s fantastic Ben.

Ben Hurlbut So thanks so much. Thanks so much, Josie, for having me. Okay. So so whereas Françoise  has the difficult diplomatic role of being both on the inside and standing on the outside, as a critic, I have the much simpler job of just being on the outside as a as a critic and and, you know, offering some thoughts on I hope on, you know, the the very worthy and valuable effort, first of all, that the summit represented and also the things that were achieved there, but also some of the gaps. I think that if the promise of these summits is is to be, well, ultimately delivered upon or even simply still sort of aspired to, we have to be quite mindful of those gaps and and attentive to them and and, you know, sort of take the time to discover them since they’re not necessarily self-evident. And I have to say that coming out of this summit, there were many things that were aggressive, that were hopeful, that were that were. And the fact of the summit itself was, you know, it was a very valuable exercise. And yet at the same time, I was struck by them. The quite significant lacuna is that were not only present but were just to a large degree unacknowledged. So let me say a little bit about what I mean by those. The idea of the summits as I understood them and as was articulated back in 2015, before the first summit, was to seek to draw together an international community, a genuinely international community, to discuss questions of not merely science, but of governance, of of the right and the good vis a vis the technology, with the potential to change the fundamental stuff of human life. That’s a weighty undertaking, one that inevitably is going to fall short in the sense that it will will never be complete. And yet, at the same time, it’s one that takes that requires a kind of serious commitment to a rich conversation, I would say an inclusive conversation, one that draws upon the sort of wealth of knowledge and experience represented within humanity, and thus also the sort of forms of wisdom. Because what’s at stake here is not a set of molecular techniques. What’s at stake here are ways of making people and making judgments about what sort of people there should be, whether people should be transformed, and in what ways in the name of what imagination of of of therapy, treatment and cure, etc.. And so and so in that sense, the summits themselves, though, they have had, you know, a certain level of attention to governance. And I think Françoise  is exactly right. There was a sort of insufficient level of attention to governance in this third summit. For example, one of the first things said by, you know, one of the representatives of of I believe this was Victor. So although I’m not sure I can’t remember that for sure. But one of the the figures who’s, you know, leading one of the organizations that convened the summit declared simply that it was impossible to have international agreement about, in effect, any of the matters that were under discussion, which is belied by the fact that while there is, in fact, an international agreement that much of Europe has been, you know, committed to for several decades, but also a kind of in in that sort of declaration of a closing the door to possibility that I mean, certainly does seem possible to plenty of the people who are involved in that discussion. But if we think about governance in broader terms, and that’s how I would want to think about it, it’s less about what are the systems of rules or constraints that are put in place and more in a sort of entomological sense. It’s a it’s a nautical term. It means steering the ship in effect. So what is steering the ship in what direction? Who is at the helm? Those are the questions of governance that we have to ask. And some of the things that I think were under-discussed at the summit and yet were also performed in a sense at the summit, maybe unwittingly, are dimensions of governance that warrant really quite serious attention, but are largely neglected. So let me just give a few of these a few examples of these for for grist for the mill here. So one is what was sort of taken for granted, and I very much appreciate what Francois has said about the need to give attention to somatic genome editing. The notion that this is just a sort of simple matter of curing people and we don’t need to talk about it, we just need to get on with it. Yeah, absolutely. That’s an absolutely problematic and incomplete approach. And yet in the discussions that took place, which were to a large degree about equity and access, there was at least to some degree a kind of taken for granted ness of the of the kind of regime of innovation, including its agenda setting. That produce a circumstance where you have really quite remarkable and extremely valuable therapeutic interventions that are basically ineffective if the project is to cure the disease, not because it can’t cure an instance of the disease, it can cure an instance of the disease, but it can’t cure the disease insofar as it is simply impossible that it could reach the vast majority of people who are affected by it. So the attention to sickle cell disease, which is a, you know, a quite a domain of real achievement in in biomedical innovation in a sense. I didn’t appreciate the extent to which the approach to innovation itself has produced the conditions of inequality that it now seeks to remedy by talking the talk of access, which you can think about it as a district, as a resource problem and a distributive problem, or to some degree, and this was touched upon. You can think about it as an innovation problem, but what about a kind of systemic organization of the kind of ecology of innovation in the way in which there are asymmetries in the agenda setting itself, that access is a kind of afterthought rather than a rather than a a starting point? Okay. So that’s one what what is sort of taken for granted. I think the divisions between innovation and then its social impact and the need to ensure that those are somehow equitably distributed, that that division in a sense separates off and renders sovereign unto itself that regime that produces those those inequalities in the first place. The second is the way that problems where problems were seen. And I mean, of course, the foremost example of this was the the so-called CRISPR babies that, you know, that kind of hijacked back to the second summit in 2018 with those problems are seen as problems of containment. So there was quite a lot of talk about, you know, what kind of reforms has China undertaken in order to basically make it very clearly illegal to do what was somewhat ambiguous in 2018, little effort to reckon with or learn from how that how that case unfolded, since if one understands it not as a kind of singular aberration, but is in some way connected to a kind of larger setting or milieu, there are questions to ask about that larger setting or milieu, but the mode of containment rather than a kind of reckoning and learning again goes to towards taking, keeping things still, taking for granted, things not asking deep questions about status quo, ways of doing business that you know, are quite are quite consequential. Then then the third thing is, I think one of the things that was really striking and perhaps Françoise , if she can do so without breaking confidence, can comment on this. One of the things that was really striking about this summit was the kind of allocation of real estate, the extensive periods of time that were given to detailed discussion of scientific advances, you know, in in somatic gene genome editing, but also in in on the third day, which was dedicated to the more controversial things like germline interventions. You know, we had we had hours of detailed scientific talks of a sort that you would see at the International Society for STEM Cell Research or the or, you know, pick your kind of professional scientific meeting where scientists are speaking to each other, presented to a much more diverse audience that didn’t need to have the detailed minutia of the data in order to make sense of the stakes of the kind of experimental work that was being done in the sort of technological possibilities it was pushing towards. And yet the room for talking about those possibilities was limited to, you know, remarkably constrained periods of time. France was in a in a kind of moment of mutiny, stole an entire half hour coffee break in order to give it to a discussion of heritable genome editing, sort of ethics and governance that was squeezed in to a, you know, a very, very tiny period of time. I was genuinely perplexed by that structure, by that agenda, and the way that it it precluded expansive conversation by focusing down on the weeds of the how and setting aside or at least pushing to the margins. The question of whether and, you know, I guess what I would say about that is whether this was intended or not, the agenda itself sort of spoke a foregone conclusion, and that is that science marches on, that the work is being done and shall be done. And what the work means. Well, that’s a question that you can nod to by saying the conversation hasn’t. Get concluded. The conversation needs to be ongoing. But if in a context like the summit, significant room isn’t given for such conversation, well, there’s a significant opportunity cost associated with that, even as there’s a kind of declaration that that conversation necessarily will and should be a kind of reactive conversation that doesn’t ask. About the ways in which the fact that the work is being done itself speaks priorities and commits to a kind of orientation vis a vis governance in which the science speaks first and the rest of us have to find ways to speak later. I’m going to quit there. I’ll say something about the observatory if you want me to. But. But let me just leave it there for now. Yeah. Okay.

Josephine Johnston Yeah. You’ve both so much on the table. So maybe I’ll just say a few little things and then ask a question. But I just wanted to help our audience to understand that they can go and see the videos of the entire three day summit. And the program is all on the Royal Society. That’s the UK Royal Society’s website. So you can catch up or in addition to all the news stories about about it. And I do want us to talk a little bit about heritable genome editing and hee hee Gen Y kind of sort of repercussions and some of that. But I can I just maybe ask us to say a little bit, just talk a little bit about what was probably a really memorable part of the summit for many attendees, which was the presentation by a patient, a sickle cell patient from the United States who’s received gene editing, you know, somatic editing therapy and has and she really testified both to the sort of devastating nature of the disease throughout her lifetime, including when she was a child that was quite moving. And then about sort of the transformation and and as we noted, like the second half of the first day was really all about sickle cell disease as a kind of key case study. And then one of the things, many things that’s notable about sickle cell disease is that it’s a disease that affects, I think, you know, over half the people with the disease, maybe more are in Africa or in India. You know, even in the United States, as many of us know, it’s extremely hard to get access to health care is not equitably distributed. So I thought her case was really moving and really exciting and I’m sure quite impactful in the room, I would imagine was in actually there in London. But but also she raised, you know, raised this huge question of just how are these million dollar therapies ever going to be available to the people that need it? And like being was saying that sort of like the end question, like, oh, we’ve made this thing now, you know, whoa, what can we do about how to get it to the people who need it? So I would love to hear you talk a little bit. Each of you reflect a little bit on that, that case and that and then that question. And it’s it’s sometimes called a new question for gene editing. But it was always a huge question, I think, which is kind of looming of like, well, we do these things, why would they be any more available than any other high tech therapy, which is just not available to people. So I’d love to hear you talk about that a little bit.

Françoise Baylis So let me offer a couple of comments. So one of them is to say that at least in terms of my participation as a member of the organizing committee for this event, I was really concerned that we not repeat what had happened previously, which was to sort of, you know, have a number of patient organizations come up and say why it’s really important that their particular disease be the focus of somatic genome editing. And one would imagine that the rhetoric would all be the same. We need to do this, it’s really important, etc.. So in conversations, I had made two points in terms of what could be an alternative to that, which is one is to recognize that there are a number of sort of civil society organizations and that they are not the same as patient organizations and could we make space for them in the program? And there was an effort to respond to that request on my part, and I think we saw that in the program. I would agree wholeheartedly. Not enough time given to that, at least in terms of how important I think it was. I can only say that I asked for more time and you can look at the program. So that’s the first thing to say. The second thing to say is that I thought it was really important to have some patients that had actually either participated in research or chosen not to participate in research, and that’s actually what we set out to do. Could we get testimonials from someone who said, Look, I made the decision to become part of the scientific endeavor to contribute to knowledge production in the hope that maybe I would also get some personal benefits. And what is it that they would say about that experience? And could we also find a patient from a similar perspective, but who would say, and I made the decision not to participate. So that was the goal around that. And I think, you know, in some ways I think we succeeded in terms of meeting those objectives and in other ways, you know, I can find fault, too. But I think it’s important to say that that was a different kind of effort that was made. So I think that’s really, from my point of view, still a success. And I think we do need to hear from patients now as to the issue of pricing. I feel very strongly about this. I think what we have and have had for a long time, not just in this case, is catastrophic pricing. Right. It just makes no sense at all. But I would contest the idea that our attention to this is something that comes at the end of the process, like, oh, my gosh, look, we’ve made these wonderful therapies. Oh, look at that. We have a problem. Costs million dollars. I think if you commit to the idea that these interventions ought to be accessible to large swaths of the population, you then do your science differently. You don’t think about this as personalized medicine. You think about how can we design templates? That’s just one kind of very simple example. So I think it is really important to ask this question now and to ask it loudly, right? How are you going to change the way you do your science so that it will be accessible? And we’re starting to hear a little bit about that in terms of the difference between ex vivo or in vivo kinds of interventions. And there’s other things that possibly could get on the table if people really thought about this seriously. But in response to your last comment, Josie, this is like. Of fractional importance relative to the fact that too many people on this planet do not have access to basic health care. And I think it is a problem of capitalism, and I think we have to name it here. We have to name it elsewhere. It’s just that this is really reaching the most ridiculous kinds of sums of money in a context where since the 1980s, it’s 1948. Actually, if we think back to the Declaration on Human Rights, we’ve said that everyone has the right to benefit from the advances made in science. And here we have an example where it’s not possible. And you could say it’s not been possible for a long time. I would agree with you. I hope we can start actually seriously looking at it. This is catastrophic pricing and it makes no sense.

Josephine Johnston Do you want to add anything to that.

Ben Hurlbut That? Yeah. Let me just let me just agree wholeheartedly with with Françoise  about the catastrophic pricing and also about the way that this is not an end of pipeline problem, but a design of pipeline problem. That is, it is what the, what the translational aspirations are of the pipeline and who the pipeline is oriented towards. Right. And I think it’s it is correct that it’s not an end of pipeline problem, ethically speaking, in that sense. I mean, what are our priorities? But also in the sense that that those who are undertaking innovation are fully aware of the sort of steps that they’re moving through and what lies at the end of the pipeline and thinking strategically about how to capture the the promise of pricing of this sort. And, you know, I mean, if you are a biotech company that has, you know, 5 to 10 years of funding, you have your burn rate, you want to get a therapy out, you want to make money on the therapy you’re you’re looking at, you know, what what are the what’s the profile of the sort of, you know, total costs that that that, you know, health health care systems are needing to absorb what drugs are going off patent in going generic such that there’s going to be surplus that which might be captured which by the way, is precisely the strategic thinking that the sort of first in class companies that are working in this domain or are thinking, I mean, this is going to be a real pricing problem down the line, but actually it’s going to come out in the wash in the short term. And so we’re going to be okay. And so we’re going to price our therapy at $3 Million. Right? Why can you price it at $3 million? You’re holding somebody’s life at ransom. I mean, I think that’s the way to think about it. It is. You plunk down the money or else you die. I mean, that it’s or you go through immense suffering before you die. I mean, that’s the that’s the sort of choice. And so I think the right way to think about it is is as a sort of ransom payment, even if for a reason you get something more valuable than just, you know, not having your personal details put out on the web or something.

Françoise Baylis Yeah, if I could just add something there. I really do think that it’s an important thing to appreciate that this is a problem of contemporary capitalism writ large. It isn’t just a problem about this particular technology. And that’s largely because we still bought into the idea that it’s, you know, whatever the market will bear as contrasted with what is a decent profit, you know, and I think we need to interrogate that because you could have a completely different way of thinking about this and sort of saying, yes, you’ve taken certain risk, Yes, you’ve done such and such an R&D. Yes, you’re supposed to make a certain profit. But we have outrageous profits in many sectors. And I think, you know, we need to we need to think about this in its broader context.

Ben Hurlbut One of the moments that I found most poignant and also most compelling was when a sort of patient advocate from India, a sickle cell patient advocate from India whose name is Gautam Dawn Gray, commented that that most that many people in India can’t access Hydroxyurea, which is like an old cheap therapy, ten, you know, ten pills for a dollar, apparently as the going rate in India. And here we have, you know, these emerging technologies which promise that, well, the initial initial high costs will reduce because technology always gets cheaper over time, etc., sort of doubling down on a system of innovation that, you know, is not disconnected. I think, Françoise , from those larger systemic problems related to health care that you’re talking about. I mean, if we invest in curing disease instead of, you know, treating disease with the sort of the sort of inadequate the middling therapies of the moment, I mean, in this country there is a sort of mode of doing doing, you know, health related welfare by investing in the future rather than in the present. And this is an investment in the future. And the the therapeutic possibilities coming out of out of somatic genome editing, etc. are going to be very significant. But they’re also going to be extremely expensive if this is the trajectory that we follow and people will basically have to choose between between coughing up the money or or, you know, living with and potentially dying with disease. Yeah, it’s a it’s a serious problem.

Josephine Johnston There are there are these two really quite amazing ambitions that many of us in the sort of ethics type community have for gene editing, which is one that it will be a moment to rethink the systems of delivery of therapies and development of therapies that it’s like this moment to rethink that, which is, you know, a huge ambition for the ADC that’s not like this is a brand new problem. It’s just that here’s another moment to really kind of rise it and see can we to be do different work here, Can we have different outcomes in terms of access? But then there’s this other kind of. Which is that we will be able to have a kind of societal consensus or rethink around whether to do one of the other things that this technology might enable, which is this heritable sum, bringing us kind of back now to this sort of heritable issue. And and that’s also a really ambitious goal, right, that we would not just do let countries decide or let scientists innovate on this. And and but we would actually engage a broader a huge swath of humanity in considering the the questions. And so I want to raise that sort of come back to that the heritable element of this and the idea of a societal consensus, which, as you know, Françoise  noted, was really prominent in the first summit and then kind of immediately a bit diluted by the second one. But like I know was an idea that you still really committed to. So how can we that’s an ambitious goal as well, reaching that kind of consensus on this particular application of the technology.

Françoise Baylis So let me say a couple of things. So I remain committed to the idea of broad societal consensus. And since 2015, I have written a number of articles trying to unpack what that could mean. And one of the things that I say very clearly and repeatedly is that a commitment to broad societal consensus is not about unanimity. It’s about unity. It’s not that everyone got to speak or say something. It’s an agreement that all ideas were on the table. And so I think already if you start thinking about what are the conditions for this kind of conversation, I think it makes sense in the abstract. For me, I can say honestly, my challenge and why I keep working on this concept is how do I upscale it? Because I know that we do this kind of consensus decision making all the time. We do it in our families, we do it in our church groups, we do it in our classrooms. We do that in order to be able to work and live together. It’s a huge problem to scale that up to the world in some way, shape or form. It doesn’t mean it’s impossible. So for me, what’s really frustrating is the ways in which people just put up barriers to say it can’t be done, it can’t be done. Crazy idea. And I have two responses to that. One of them is to say it’s not a crazy idea at all. We in fact, have lots of evidence that this can be done. And the simplest one which connects up directly to this area is the 14 day rule for human embryo research. Right. So some countries have that in legislation. Other countries have it in guidelines. Some countries have nothing but the members of their scientific community who wish to be able to be published or to participate in certain kinds of international fora understand that that’s a demarcation line. Now, many people may know that demarcation line is currently under threat, right? Meaning people want to change it and it may well change and may well change quickly. Right. The fact that it changes has nothing to do in terms of undermining the fact that for 40 plus years we had a consensus about this. So I get really frustrated when people say, no, no, no, we can’t have a consensus. And then they turn around and talk about the 14 day rule as an example of a consensus. I would go further. We actually have a consensus right now that you should not do heritable human genome editing. We just don’t say that out loud. We can’t say that. We just keep saying, well, it’s not permissible at this time. Well, what does that mean? That means we have a consensus that you shouldn’t do this. And then you add on at this time, which is what sort of for some people becomes really critical. But if you were to actually put that into grammar, they would say you don’t need that at this time. If you say it remains unacceptable, it’s clearly at this time that’s the time that you’re saying it. So my first thing is to say it clearly is possible to have a consensus on something now. Can we have it in this area in a way that would be thought of as sustainable? Maybe, maybe not. But my second point that I insist upon is we will all be better off for having tried, right? Because what consensus building asks of you as a participant in that exercise is to listen to other people with respect and to hope that they too will listen to you with respect, to understand what are their cares and concerns, and to try to be respectful and to struggle along. Right. And that’s what we do all the time when we commit to consensus building. And I am and I remain frustrated that some people think out of hand. We just have to put it aside while we have evidence that it can happen. And we will all be better off for trying, even if we don’t succeed in this particular instance.

Josephine Johnston Thank you, Françoise . Do you have anything on that? Ben? That was really clear.

Ben Hurlbut Yeah. I mean, just that I tend to agree with most of the things that Francois says. I do agree with this one, too. But. But sort of, I guess, affirms something even more deeply and then disagree on one little point. So first of all, I absolutely agree that the process of seeking after consensus is, in a sense, the result. To a large degree, those processes of deliberation that invite in perspectives that would otherwise not be there, that shift the frame that that, you know, enrich a kind of sense of what’s at stake and thereby engender humility, hopefully amongst those who have who at the start of that process enjoy a position of particular influence that is an important result in itself. And I think one of the things that we underappreciated in this domain, we think that it’s about technology, but really it’s about our modes of contending with our own projects and emerging capacities, technological and otherwise, for transforming human life, including social life. And the the efforts to transform social life in a positive direction by engaging in robust forms of deliberation around these questions. That’s only for the good. The what results from these processes is not just a policy vis a vis a technology, but ways of approaching governance that have a kind of staying power, a stickiness, a durability. So I think appreciating that matters. Furthermore, if one approaches it in that way, consensus is not a question of, you know, answering a yes or no question vis a vis a particular technology. There are all sorts of intermediate forms of consensus indeed, about what kinds of questions need to be asked about in what terms they need to be asked through, what fora with what kind of of, you know, sort of persistent openness versus moments of resolution and closure. I mean, these are these are intermediate forms of consent, but that seems to be actually where the where the action is. And the one thing that I would disagree with that Francois said is that at this time, that the at this time is a sort of, you know, a little addition that can easily just be chopped off the end. And then we would have a have a consensus. I think the at this time is actually doing an enormous amount of work in terms of foreclosing the possibility of making precisely the kind of judgment, Françoise , that you suggested, because at this time, which is interchangeable with premature, suggests a kind of natural process of maturation, of technological maturation, which is also in some sense linked to an idea of how these questions should be asked and when they should be asked. And if the if it doesn’t mature to a point where it would be usable, why on earth do we need to have some sort of consensus about whether it should be used or not used? That is tightly coupled to the notion that once it has matured to a point where it is usable, there’s no point in having a consensus about whether or not it should be used because it’s inevitable that it will be used. I mean, that seems to me to be the just ubiquitous double move. That is it. That is one of the sort of prime movers, one of the the regulative frames that shapes the conversation in this domain. And I think it goes back to that kind of allocation of real estate, even in the context of the summit, the the sort of, you know, sovereign position of science that does what it’s going to do and produces the capacities that it’s going to produce that that perhaps then invite questions from the rest of society about whether it wishes to to, you know, deploy or constrain the deployment of those technologies already produced. It does not invite the question what kind of research is good in the name of what collective goods to what, what aspirations to the good inform the directions that this project of scientific research reflects and uses as its guiding light?

Françoise Baylis Yeah. So I want to I want to be clear. I do think that the at this time is doing work. I didn’t mean to suggest it wasn’t doing work. I was making the point that is grammatically not required. And so the fact that it is there is something we should pay attention to, and it is what provides some people with comfort because they think they’re saying one kind of a thing as contrasted with another kind of thing.

Ben Hurlbut So if you can if you can get people to drop that, I’m all for it. But I put my lifetime but my sense project, my sense is that it’s that it’s a power move. It’s about holding open a future. It’s and it’s sort of delimiting. It’s it’s rendering less significant. The the the the views that are held, the feelings that are held in the present, those are just temporary. Those are incomplete. Those are themselves immature.

Josephine Johnston So we’ve actually tackled a couple of the questions that I saw in the Q&A in the chat, which is like, what is this main societal consensus? And also, you know, we assume that this is all going to turn out to be beneficial, you know, safe and effective, and we’re going to go for it. And I think those were some of that was some of the sort of and the questions here. But, Dani, do you want to put another a few a couple other questions sort of in front of us? I know we have quite a few.

Dani Pacia Yes, definitely. There’s a lot of great questions. One is building on this idea of consensus. An attendee asks, One of the things that we’ve learned during COVID is that if all ideas are on the table, we are going to get some wildly divergent ideas. So does societal consensus really mean that all ideas need to be respected, or is there some other filter that ought to be applied?

Françoise Baylis So as I said, I spent a fair bit of time now writing and thinking about this and just a plug for the book. I have a whole chapter on consensus building in the book Altered Inheritance. And one of the things that I talk about there is you’re trying to start off by getting all the ideas on the table, but you know that not all the ideas are going to be endorsed in some way, shape or form. So that’s the start or the beginning of the process, if you will. I think what then becomes important is to think through what it means to participate responsibly in conversation. So there’s two things I would highlight here. The first thing is if you’re going to try genuinely to participate in any kind of a consensus building exercise, you have to have humility. And that means you have to genuinely believe you are not the smartest person in the room. It is not the case that you already have the answer and you’re going into this conversation simply to persuade other people. It must be possible that in theory you could learn from something someone said. So that’s the first thing. And that in theory, everybody has to be willing to do so. You’re going in with an open mind, willing to learn that in and of itself for some people will be very hard. Beyond that, though, one of the things I talked about is this You’re genuinely committed to this kind of an exercise. Another part of that has to do with responsibility. So not just humility, but responsibility. And what I talk about there is if all ideas are on the table, it means that your idea has been discussed. Your idea has been debated. And in that context, you reach a point where if you’ve explained it many, many times and people have said, I have heard you many, many times and they’re saying we can’t endorse that view, at some point that view comes off the table. And then part of being responsible is being able to acknowledge I have had my turn. I have had my say. I have not been able to persuade persuade. And it’s just possible that on this issue, I am wrong. And so I actually withdraw. I don’t keep fighting. Now, there are ways in which it gets much more complicated. I talk about the importance of struggle and what that means. So I’m not asking for people to lay down and give up on the things they believe. You know, and I talk a lot here about integrity, integrity, preserving compromises. I mean, I think it’s actually a really interesting way of trying to unpack this. And I will say other people are trying to do this work. So recently, I had an opportunity to meet and read some of Joy Zhang’s work, and she’s talking about this in the context of commenting. And she has reason to believe and I don’t disagree with her, that maybe that language would be more inclusive and that people would be easier able to think about a commitment to committing to looking for what we have in common. I mean, it’s much more sophisticated than that, but I’ll let her present her own work. But I think that’s really what I’m talking about. It’s finding a new way to have a conversation where people are not coming in, as we would say in French participe that they’re already deeply committed and the work of other people is to shift them. And I want people to come in not having everybody else having to commit to shift, but you coming in, willing to be shifted, willing to think that there’s something I can learn here.

Josephine Johnston Dani, you want to put another question? There was one that I saw that about governance that I thought might be helpful, but.

Dani Pacia You should go ahead and you can ask it, Josie.

Josephine Johnston Okay. So there was a question in the Q and I and I noticed some I think some the audience can’t see the Q&A, but there was a really good question about like, suppose we can get some kind of consensus. How what, what would governance look like? What would global governance look like? And so I wanted to. Yeah, I know. I don’t know if that’s a topic that came up for the observatory. And the observatory said like meetings. Someone else also noted that there were all these satellite meetings that happened around the summit. So and one of them was the Global Observatory. So yeah, I’d love to just hear some responses to that question about governance and global governance being, do you want to maybe start?

Ben Hurlbut Yeah. So I guess I am disinclined to say what the singular design principles of the institution or institutions that do the governing should be. I think that we are that is that is also putting the cart before the horse that the where we have deficits it’s in the the forms of capacity for fostering and not just fostering, but sustaining and drawing from and consolidating from the kinds of deliberation that Françoise  just described. Instead, we have, you know, of an institution that understands itself as a kind of international or place this institution, namely science. And we have it sort of spinoff formations like professional scientific societies that do that, in effect, set policy. They call them guidelines, but they have a kind of transcendent position that that, you know, is supposed to touch down in different jurisdictions and sort of be adopted as the most informed and the most up to date and etc., etc.. I mean, I think that that there are. That those are problems that have to be overcome not by putting in place some kind of structure, to which we then invite the relevant stakeholders and have the process, the consensus conference that puts forward the the policy or whatever. It seems to me that the questions around human genome editing broadly conceived, I personally actually reject the somatic germline distinction as some sort of fundamental metaphysical distinction that needs to be respected. I think that those that this is a domain that’s important precisely because it quickly and easily draws to the surface questions about and for humanity that are not going to go away and are. And it is not as though this is a moment in the history of biotechnology that where they will pop up and then they will settle back down. Rather, it’s the sort of tip of a much larger iceberg that we are going to be contending with, you know, decades, centuries, etc.. And the commitments made now will have profound ramifications if a sort that we can’t see further down the line. So so to me, the most important step is sort of recognizing the nature of the problem, which is not a nature of governing the technology of the moment, but but committing to the creation of the fostering of and the sustainability of those fora through which the kinds of deliberation that Françoise  is describing are invited, encouraged, and have a perpetual use in guiding and governing our technological future. That is a sense. The spirit in which the Observer, the Global Observatory project is undertaken to do pretty simple things like convene unconventional conversation partners, people who might not otherwise find themselves in the room, in a room together. But both have things to say and thereby can, through kind of encounter in juxtaposition, engender the sort of humility that Françoise  was talking about. It’s it’s asking whether we’re asking the right questions, what other questions could be asked, What happens to the deliberation if a different agenda is set, if a different starting point becomes the starting point to not begin with technology, but to begin with ways of valuing the human, including the deficiencies that we have in the ways of valuing human life that govern us, and ask whether those deficient ways of governing are the ways we want to govern the development of these technologies which do have the potential for profound impact and transformation. Right, including the re inscription of of unjust, of misguided, of deficient of deficient ways of of governing ourselves, of of aspiring to make people better. Right. So so to me, the institutional answer, the institutional design answer is necessarily heterogeneous. It’s necessarily multi scalar from the level of the local all the way up to the level of the international. There’s no singular place where the problem is going to be solved. There’s no singular discourse in which it’s going to be solved. There’s no singular moment at which a resolution will be achieved and then everything can go forward and we can be done with this societal consensus nonsense and get on with the science as people as our as our scientific colleagues will often in moments of honesty, say, I think that that is a you know, that that sort of orientation is fundamentally contradictory to the kind of deliberative project that Francois was describing.

Josephine Johnston So I think we may need minutes, but I want to give you Françoise . Sorry. I want to give you the last I think probably the last word on on this, even though there are all these other questions about enhancement and various other things that we haven’t got to. But Françoise  and then I will well have to close there.

Françoise Baylis So let me just offer two quick comments. The first one is to say that in the context of the work that I did with W.H.O., part of what we tried to do in that building of a framework, if you will, for governance, because we were responding to our charge from the director general, was to actually try to broaden that concept so that people don’t think of governance just in terms of things like legislation, guidelines, codes of ethics, etc., but that we really were thinking about it more broadly. So, you know, the patent system is a form of governance, you know, and we could call that into question. You know, journal policies are a form of governance and we could think about that. Quite frankly. The education of young scientists is a form of governance. And so in that work is an effort to try to say, why don’t we start probably itemizing what we think counts as governance. So that’s the first comment. The second one, and it’s I’ll just offer it up in the context of you said there were questions about enhancement, which we haven’t got to different people draw a big distinction between therapy, good enhancement, bad. I don’t accept that. And in fact, in the book I talk very much about why, in fact, just the therapy enhancement distinction doesn’t work. But a phrase that I find helpful in this regard for people to think about is the difference between making people better and making better people. And I think that there’s something really important if we use that lens, to interrogate what it is that we’re doing and in terms of what is it that we are pursuing, what is it that we think is the good In that context, I think there is still work to be done, but I don’t think it’s this neat divide between therapy and enhancement.

Josephine Johnston Thank you so much. I’m sorry to have to end the conversation. Honestly, I feel like there are more questions that we could discuss, and we certainly won’t drop this topic of Hastings, you know. Well, I’m sure I have another another another session of some kind on this, these questions, you know, and a future date. But I just wanted to thank Françoise  and Ben for the year for joining us, for sharing their thoughts, for like being willing to distill things into, you know, fewer words then then we’ll then then we like to be able to have and to our audience for their questions and for for joining us and pass it back to Dani. So thank you very much.

Dani Pacia Thank you all for attending. Like we said earlier, in the event, there will be a recording available later today with closed captioning and other accessibility features.

Josephine Johnston Thank you.