--:-- Sean Rameswaram: It's a big week for baby KJ. After spending nearly his entire first year of life in the Children's Hospital of Philadelphia, he is going home.
--:-- Jason Mast: Baby KJ is not like your average baby. He was diagnosed with a rare genetic disease shortly after birth, something that roughly one in a million babies have.
--:-- Sean Rameswaram: But baby KJ got a genetic treatment for it that no baby has ever had. And it worked.
--:-- Jason Mast: He's had quite a nice little growth spurt. I like to think it's really helped him grow some nice chubby cheeks.
--:-- Sean Rameswaram: Man, the day he walks into, like, school with a book bag on and we, like, let him go at the door, like, he might have to take the day off that day.
--:-- Jason Mast: The miracle of baby KJ coming up on Today Explained.
--:-- Sean Rameswaram: KJ, buddy, what you doing down there?
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--:-- Jason Mast: Adio says it also allows you to create those email sequences, those real-time reports, those powerful automations, which they claim can help you build what matters most, your company.
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--:-- Jason Mast: That's attio.com slash todayexplained.
--:-- Sean Rameswaram: Support for this show comes from Macy's.
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--:-- Sean Rameswaram: Explore the Macy's Fall Guide for yourself and shop in-store or online at Macy's.com.
--:-- Jason Mast: This is Today Explained.
--:-- Sean Rameswaram: Jason Mast writes about science, medicine, and biotech over at Stat News.
--:-- Jason Mast: Lately, he's been writing about baby KJ. Who is adorable.
--:-- Sean Rameswaram: We asked him to tell us about the baby.
--:-- Jason Mast: So baby KJ was born last summer. He was the Muldoon's fourth child.
--:-- Sean Rameswaram: Five weeks before KJ was supposed to be born, Nicole called me and said, we got to go to the hospital, like now.
--:-- Jason Mast: I don't know, six hours later, KJ was here.
--:-- Sean Rameswaram: They're told that he's quite healthy and we're going to put him in the NICU for now, but, you know, he'll be back with you very soon.
--:-- Jason Mast: And then basically within 48 hours, a nurse pulls Kyle aside, the father, and pulls up KJ's arm and drops it down.
--:-- Sean Rameswaram: And instead of flopping, as you would expect a baby's arm or anyone's arm really to do, it kind of shutters down.
--:-- Jason Mast: And what they find is that his ammonia levels are in the thousands, when it should be, like 10 or 20.
--:-- Sean Rameswaram: And this is very dangerous.
--:-- Jason Mast: This toxin, ammonia, builds up in your blood and then eventually will build up in your brain.
--:-- Sean Rameswaram: If that went on unchecked for a day to two days, the patient would be at very high risk of death.
--:-- Jason Mast: One of the doctors came to us and said, we think we know what's wrong.
--:-- Sean Rameswaram: Your son is very sick.
--:-- Jason Mast: But the best place in the world for your child to be when he's very sick is next door.
--:-- Sean Rameswaram: So they rushed KJ across the street, basically, to the Children's Hospital of Philadelphia from UPenn Hospital.
--:-- Jason Mast: And they immediately put him on medicines to bring down that ammonia, put him on a strict diet, and they sequence his genome.
--:-- Sean Rameswaram: And they say, okay, what exactly is the issue here?
--:-- Jason Mast: And they find that he has a mutation in this one gene. CPS1.
--:-- Sean Rameswaram: But what they realize is that this is actually a mutation that might be editable, that we might be able to make a gene editing treatment for.
--:-- Jason Mast: We either have to get a liver transplant or give him this medicine that's never been given to anybody before, right?
--:-- Sean Rameswaram: I mean, what an impossible decision to make.
--:-- Jason Mast: I just think that we felt like this was the best possible scenario for a life that at one point we didn't know if he would be able to have.
--:-- Sean Rameswaram: For the last couple of years, they had been basically preparing for a baby like KJ.
--:-- Jason Mast: Because there had been all these advancements in gene editing over the last decade.
--:-- Sean Rameswaram: Many of your listeners probably have heard vaguely of CRISPR.
--:-- Jason Mast: There's one drug already approved for sickle cell.
--:-- Sean Rameswaram: There's more in the works.
--:-- Jason Mast: But the advancements had come to the point where you could make these really fine-tuned changes in DNA.
--:-- Sean Rameswaram: And that both creates some opportunities and some challenges.
--:-- Jason Mast: And the opportunity is there you can, like, treat as, you know, happened with KG ultimately.
--:-- Sean Rameswaram: You can treat an individual patient's mutation, but you can only treat maybe that patient or this small handful of patients with this one very precise mutation.
--:-- Jason Mast: In cases like KJ, you're going to need to actually make that treatment really quickly.
--:-- Sean Rameswaram: In these really severe metabolic diseases of infancy, we know that we have to act quickly if we're going to make a difference in the lives of these babies.
--:-- Jason Mast: And so they were like, can we do this in time ourselves?
--:-- Sean Rameswaram: Can we go from an infant and make a treatment in time to help them?
--:-- Jason Mast: Because this is like a first-time deal.
--:-- Sean Rameswaram: This is like an experiment.
--:-- Sean Rameswaram: And they had been running what they called sort of time trials where they like would pick a variant that's in the literature or that Becca would encounter.
--:-- Jason Mast: And they would see how fast can we do this?
--:-- Sean Rameswaram: Not with any intention of we're going to put this in a patient, but we're just going to see how fast can we do this?
--:-- Jason Mast: And initially it takes over a year and that was a couple years ago.
--:-- Sean Rameswaram: But they get faster and faster until they can do it in what seems like a number of months.
--:-- Jason Mast: And what that starts is basically a six-month sprint to can we build this therapy in time?
--:-- Sean Rameswaram: And he brings researchers and companies in California, in Boston, in Vancouver, in Iowa, all sprinting, working overtime to see can we build this treatment before KJ either needs a liver transplant or has an ammonia attack that's going to really cause some long-term damage.
--:-- Jason Mast: We had learned everything we needed to learn to actually get it all done in six months in time to actually help them.
--:-- Sean Rameswaram: They managed to get it tested in mice and monkeys.
--:-- Jason Mast: They managed to, you know, do some testing on it to make sure that it doesn't accidentally edit the wrong portion of the genome.
--:-- Sean Rameswaram: They get companies who basically are willing to, like, manufacture this at relatively low cost or for free.
--:-- Jason Mast: It's not clear exactly like a branch in but they were able to sort of cut a deal with these manufacturers
--:-- Sean Rameswaram: And at six months ABKJ is treated with the first dose This is in February.
--:-- Jason Mast: It's not amazingly effective, the first one, because it's a very small dose.
--:-- Sean Rameswaram: They want to be very careful.
--:-- Jason Mast: But then they go for a second dose a few weeks later.
--:-- Sean Rameswaram: And then the third dose, not yet clear how the third dose has gone.
--:-- Jason Mast: But after the second dose, they were able to really lower the medications he had been on to control ammonia.
--:-- Sean Rameswaram: And they were able to loosen his diet so he could start eating protein for the first time, really, and, like, growing.
--:-- Jason Mast: And they no longer expect to give him a liver transplant.
--:-- Sean Rameswaram: And they're hoping he has a, you know, not cured, but a much more mild form of his condition.
--:-- Jason Mast: And for people who are wondering how you edit a living baby's DNA exactly, or a monkey or a mouse, how do you do it?
--:-- Sean Rameswaram: There's basically a delivery vehicle that's required to get your gene editing machinery into the liver.
--:-- Jason Mast: And they use what's called a lipid nanoparticle, which is basically a tiny little soap bubble that's very, very, very, very, very small.
--:-- Sean Rameswaram: That's sort of the delivery vehicle.
--:-- Jason Mast: And then inside of that, you put basically two components.
--:-- Sean Rameswaram: There's a gene editing protein that's sort of a two-part protein.
--:-- Jason Mast: It nicks DNA, and it has a part that changes a single letter from one to the other.
--:-- Sean Rameswaram: And then there's what's called a guide RNA, which is basically GPS coordinates.
--:-- Jason Mast: And in this case, we programmed it to go to the site of the genetic variant that is actually causing the disease in KJ.
--:-- Sean Rameswaram: So you have a GPS coordinate within the genome for which letter to switch.
--:-- Jason Mast: You have a protein that switches the letter.
--:-- Sean Rameswaram: And you have this sort of FedEx envelope of a soap bubble that gets it into the liver.
--:-- Jason Mast: It sounds very technical.
--:-- Sean Rameswaram: But, like, is another word you could use for this miracle?
--:-- Jason Mast: I feel like in general, in science journalism, we avoid words like miracle and like cure quite often.
--:-- Sean Rameswaram: But it is like, it is amazing.
--:-- Jason Mast: This is not a thing that could have been done for most of, until like basically very, very, very recently.
--:-- Sean Rameswaram: This is a thing that like researchers have been trying to do.
--:-- Jason Mast: So this being sort of like broadly treat these kinds of conditions for a very long time.
--:-- Sean Rameswaram: You can look back at like publications and how people talked in the 80s or 90s when they kind of thought they were on the threshold of being able to, you know, replace genes and do things like this.
--:-- Jason Mast: And they weren't.
--:-- Sean Rameswaram: And it didn't work.
--:-- Jason Mast: And now you hear you have a baby like KJ.
--:-- Sean Rameswaram: And we don't yet know what his life will hold.
--:-- Jason Mast: We don't yet know exactly how well this works.
--:-- Sean Rameswaram: But like the early signs are very promising.
--:-- Jason Mast: And that is it is it is incredible.
--:-- Sean Rameswaram: And it comes out of, like, all of this gritty, biochemical, unsexy work and all this funding over all these years that have now produced this.
--:-- Jason Mast: Fairly soon, if all goes well, all six of us will all be able to, like, be at home, sit on the couch, watch a movie.
--:-- Sean Rameswaram: Like, we're planning for him to come home.
--:-- Jason Mast: Are other people getting in line?
--:-- Sean Rameswaram: I mean, so this is the big question, and it's sort of the more pessimistic, like the easy thing to do, sort of like if you're skeptical, is to look at this and be like, amazing, exciting, love that this happened.
--:-- Jason Mast: For KJ, researchers pulled off something incredible, not repeatable.
--:-- Sean Rameswaram: You can't do it again.
--:-- Jason Mast: It's not going to work.
--:-- Sean Rameswaram: And they have a really valid point.
--:-- Jason Mast: The researchers involved here won't say how much it costs.
--:-- Sean Rameswaram: It definitely costs them millions of dollars.
--:-- Jason Mast: There's no one pulling up that money to make that at scale for thousands of infants or even hundreds of infants or even dozens of infants.
--:-- Sean Rameswaram: This was supported in part by the NIH who helped do some of the manufacturing for the monkey studies, if I recall correctly.
--:-- Jason Mast: And the NIH is currently facing massive funding cuts.
--:-- Sean Rameswaram: And so where is the money, where is the process going to come to do this at scale?
--:-- Jason Mast: Also, I should add, you can only do this basically with a couple different types of conditions.
--:-- Sean Rameswaram: You can do it with conditions that affect the liver.
--:-- Jason Mast: You can do it, it's more complicated, but you can do it with conditions that affect the blood.
--:-- Sean Rameswaram: Pretty much anything else, researchers are not yet at a place where they can reliably do this kind of gene editing work.
--:-- Jason Mast: And so for now, this won't be a one-off, but there won't be that many patients who benefit from it in the next few years, probably not.
--:-- Sean Rameswaram: Is there anyone who's saying, hold the line, maybe this isn't the best idea?
--:-- Jason Mast: Is there anyone pushing back?
--:-- Sean Rameswaram: So there's someone who's like, no, they should not have treated KJ.
--:-- Jason Mast: But there will be, and there have to be discussions around what is the best use of our resources?
--:-- Sean Rameswaram: Should we be doing these N of one cases versus trying to find ways of treating large swaths of diseases?
--:-- Jason Mast: If it's going to be so resource intensive for one patient, there's going to have to be considerations about, you know, you can, the less testing you require, the more patients you can treat.
--:-- Sean Rameswaram: So there's going to have to be discussions around how much testing you do and what is safe and what is a good bar for efficacy and who pays for this, which diseases require this versus that you're going to have to demand a lot more testing, as I was saying.
--:-- Jason Mast: And those will be a bunch of ethical questions that the field will have to figure out and will not be easy.
--:-- Sean Rameswaram: People are in favor of this overall, but the question is when and for who and who pays and a lot of naughty issues on the horizon.
--:-- Jason Mast: Read Jason Mast at statnews.com.
--:-- Sean Rameswaram: People don't seem to have too many issues with using CRISPR to edit the genes and save the life of a living, already-born baby KJ.
--:-- Jason Mast: But do not get people started on the embryos.
--:-- Sean Rameswaram: We're actually going to get someone started on the embryos when we're back on Today Explained.
--:-- Sean Rameswaram: Today Explained comes from Chime.
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--:-- Sean Rameswaram: And Chime gets that, says Chime.
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--:-- Sean Rameswaram: You can open an account in two minutes at chime.com slash explained.
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--:-- Jason Mast: Chime is a financial technology company, not a bank.
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--:-- Sean Rameswaram: Chime checking account required.
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--:-- Jason Mast: Like, really happy?
--:-- Sean Rameswaram: The unfortunate fact is that a huge number of people can't say yes to that.
--:-- Jason Mast: Far too many of us are stuck in a job we've outgrown.
--:-- Sean Rameswaram: Or one we never wanted in the first place.
--:-- Jason Mast: But still, we stick it out.
--:-- Sean Rameswaram: And we give reasons like, what if the next move is even worse?
--:-- Jason Mast: I've already put years into this place.
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--:-- Sean Rameswaram: From fitness routines to mental resilience, navigating personal goals to tackling burnout, each episode is full of relevant insights and clear takeaways about things we all could use a little help with.
--:-- Jason Mast: LifeKit wants to help you approach your own life with confidence and clarity and walk away with a game plan you can implement right away.
--:-- Sean Rameswaram: Enough from me.
--:-- Jason Mast: Go listen to the show, Life Kit.
--:-- Sean Rameswaram: It's a podcast from NPR.
--:-- Jason Mast: Today explained.
--:-- Sean Rameswaram: Now you say, now France says.
--:-- Jason Mast: Today explained.
--:-- Sean Rameswaram: Good job.
--:-- Sean Rameswaram: Scientists used CRISPR technology to edit the genes of baby KJ to save his life.
--:-- Jason Mast: But let us not forget that we have also, as a human race, used CRISPR to edit the genes of an embryo.
--:-- Sean Rameswaram: A scientist in China in 2018 manipulated embryos that were then taken from the lab, put into a woman in the hope of establishing a pregnancy.
--:-- Jason Mast: And it turns out that at least two pregnancies were established.
--:-- Sean Rameswaram: Two beautiful little Chinese girls named Lulu and Nana came crying into the world as healthy as any other babies a few weeks ago.
--:-- Jason Mast: One couple gave birth to twins in 2018, and then a third child was born in 2019.
--:-- Sean Rameswaram: Those children are born of genetically modified embryos, which means that they are in fact the first genome-edited children, and they get referred to as the CRISPR babies.
--:-- Jason Mast: During IVF, a technology called CRISPR was used on embryos, disabling a particular gene that allows HIV to enter a cell.
--:-- Sean Rameswaram: CRISPR is the technology, just an acronym that stands for Clustered Regularly Interspaced Short Palindromic Repeats.
--:-- Jason Mast: And you can appreciate why nobody would want to say that out loud, and so they are our CRISPR babies.
--:-- Sean Rameswaram: Their genes were reportedly manipulated to see if we could create humans who could be resistant to HIV, smallpox, and cholera.
--:-- Jason Mast: That seems good, right?
--:-- Sean Rameswaram: But there was a lot of debate.
--:-- Jason Mast: We invited bioethicist Francoise Bayliss to tell us why.
--:-- Francoise Bayliss: In a way, to tell the story accurately, one needs to appreciate and know that the initial response, which was largely on social media in China following this announcement, was really quite positive.
--:-- Sean Rameswaram: It's not morality, it's cowardice to seek permission from 30 governing bodies before taking every step.
--:-- Francoise Bayliss: Nice work. If you can help parents with a genetic disorder have a healthy baby, I don't understand why people are so upset.
--:-- Sean Rameswaram: I mean, Nazi scientists went to hell in a handbasket, but produced some of the most influential research of the 20th century.
--:-- Francoise Bayliss: Very shortly thereafter, however, it shifted and changed because as people were basically responding online around the world, you were really hearing a different kind of tone.
--:-- Sean Rameswaram: I would say that no babies should be born at this point in time following the use of this technology.
--:-- Francoise Bayliss: There has been consensus that to take a embryo with altered genes and put it in a woman to create a child is just beyond the pale in terms of what's morally acceptable.
--:-- Sean Rameswaram: And very quickly you see this shift happen to the point that a lot of the social media in China disappears.
--:-- Francoise Bayliss: So what it looks like now is that you have, from the beginning, a consistent, coherent perspective that this is deeply problematic science.
--:-- Sean Rameswaram: And the only context in which it's seen differently is a couple of individual scientists who either are amongst those who just believe science should be free, we should endorse blue sky science, and others who actually wanted to do the work themselves.
--:-- Francoise Bayliss: And so you have a small pocket of people who are saying, no, this is actually tremendous. This is, in fact, important progress. We need to do this Some will add we need to do this responsibly
--:-- Sean Rameswaram: How long have we as a species been trying to alter our DNA or thinking about it?
--:-- Francoise Bayliss: Oh, probably been thinking about it for a very long time. If you include people that do science fiction writing, right?
--:-- Sean Rameswaram: And I think it's always in the context typically of an enhancement.
--:-- Francoise Bayliss: So it's actually not limited to the idea that we would be able to offer therapeutic interventions to people, but rather that we'd be able to make new humans, superhumans.
--:-- Sean Rameswaram: The imagination really kind of moves in a particular direction once we actually have the human embryo outside of the body.
--:-- Francoise Bayliss: And that's happening in the 1970s.
--:-- Sean Rameswaram: So once we get the human embryo outside of the body, we have the ability to manipulate this thing.
--:-- Francoise Bayliss: We begin to study this thing, right? What happens when we take this and put it back into a uterus?
--:-- Sean Rameswaram: And then once it is in a woman's body and is continuing to develop, we have all kinds of other technologies we use to scrutinize the development and to see whether or not we think we're going to have a healthy birth.
--:-- Francoise Bayliss: And so it's in this context that we now start imagining, well, if this isn't on the right track, what do we do?
--:-- Sean Rameswaram: Well, could we identify embryos that have a problem before we actually transfer them?
--:-- Francoise Bayliss: And then you'd only transfer the healthy embryos.
--:-- Sean Rameswaram: And we make that transition in the 1990s.
--:-- Francoise Bayliss: So we go from being able to look at the embryo, thinking about transferring the embryo in a healthy context, to getting to a point where we can take the embryo and look at it and make a judgment about its quality and then decide to transfer or not.
--:-- Sean Rameswaram: And now getting to the stage where we're thinking, well, while we're looking at this thing in the lab, why don't we just tinker with it?
--:-- Francoise Bayliss: And there's some risks to doing that tinkering.
--:-- Sean Rameswaram: Well, there's always risks to doing tinkering because the important thing about research is it's a step into the unknown.
--:-- Francoise Bayliss: We don't actually know what we're going to do, what we're going to find.
--:-- Sean Rameswaram: And that's true whether we're talking about patients enrolled in a clinical trial or whether we're talking about biological material in a laboratory.
--:-- Francoise Bayliss: So I think we need to appreciate that when we don't know, we don't know the good things or the potentially harmful things.
--:-- Sean Rameswaram: And I think that's the context in which many people are worried about manipulating the human embryo
--:-- Francoise Bayliss: Because if you've made a mistake, that mistake will be visited upon generation after generation after generation.
--:-- Sean Rameswaram: You're going in, you're cutting the DNA, and you could just mess things up.
--:-- Francoise Bayliss: Is anyone regulating this process?
--:-- Sean Rameswaram: I mean, thinking about what's going on with the, I don't know, scientific community in the United States right now, funding is being pulled.
--:-- Francoise Bayliss: Regulations are being revoked.
--:-- Sean Rameswaram: What's going on in the rest of the world when it comes especially to gene editing?
--:-- Francoise Bayliss: If you were to look at it globally, I would say to you about half of the world's countries explicitly prohibit this kind of research.
--:-- Sean Rameswaram: No country explicitly permits this kind of research.
--:-- Francoise Bayliss: And there are a number of countries where they haven't bothered to write anything about this research.
--:-- Sean Rameswaram: And just to put that in perspective, I mean, you can think about small islands.
--:-- Francoise Bayliss: My family comes from Barbados. It's a very small island in the Caribbean.
--:-- Sean Rameswaram: Why would they take up any of their policy effort to try to regulate in this space?
--:-- Francoise Bayliss: It's not research they're likely to pursue.
--:-- Sean Rameswaram: Does baby KJ get us closer to both more treatments like his and also maybe more people wanting to edit genes?
--:-- Francoise Bayliss: I think it does.
--:-- Sean Rameswaram: And I think it's going to make for some very interesting and difficult conversations, conversations we need to have.
--:-- Francoise Bayliss: So it's absolutely true that there's a lot of enthusiasm for what looks like a successful treatment for a person who otherwise would have had a number of complicated health challenges.
--:-- Sean Rameswaram: As we continue to develop that, you will have people say, why are we doing this?
--:-- Francoise Bayliss: Like, shouldn't we just do one and done?
--:-- Sean Rameswaram: Like, shouldn't we just fix this in the embryo such that when that person is born, they don't have the condition and none of their children will be at risk of having the condition?
--:-- Francoise Bayliss: Because depending on where you go right now, you will be treating people who will go on to live and may choose to reproduce and may have offspring with the very same condition that they had for which they were genetically modified.
--:-- Sean Rameswaram: I understand that, but I also think that it's a mistake to go down that path, with that project, you are trying to take over the human evolutionary story.
--:-- Francoise Bayliss: And I think that's a really, really significant move.
--:-- Sean Rameswaram: For some, it'll be about awe, and for others, it'll be about hubris.
--:-- Francoise Bayliss: And the reality of it is, we can't know what the future will bring, and it's a space in which people will say, should we invest time, talent, and treasure?
--:-- Sean Rameswaram: And I'm going to say back in that context that I think if you're looking at therapeutic interventions, the number of persons that you would create is infinitesimally small.
--:-- Francoise Bayliss: So I want you to think about that.
--:-- Sean Rameswaram: What else could you do that might have a more important impact over time?
--:-- Francoise Bayliss: Francoise Bayliss is a distinguished research professor emirata at Dalhousie University in Halifax, Nova Scotia, Canada.
--:-- Sean Rameswaram: Our episode was produced by Victoria Chamberlain, edited by Miranda Kennedy, fact-checked by Abishai Artsy, and mixed by Patrick Boyd and Andrea Christensdottir.
--:-- Sean Rameswaram: I'm Sean Ramos from this is today Explained from Vox, which is offering membership at 30% off the typical rate right now.
--:-- Sean Rameswaram: Membership includes ad-free podcasts.
--:-- Sean Rameswaram: FYI, you can support our work at vox.com slash members.
--:-- Sean Rameswaram: Also, Vox lost one of its biggest supporters to cancer this week.
--:-- Sean Rameswaram: Allison Rocky was one of the earliest employees here and one of our most consequential leaders.
--:-- Sean Rameswaram: She had a hand in managing just about everything Vox launched in the first several years of its existence, including Today Explained.
--:-- Sean Rameswaram: She hired me, she hired Noelle she helped get us on the radio she was fiercely dedicated to this place and its mission of helping people understand the news and she will be fiercely missed thank you Allison Thank you.
