Ethical Issues with Artificial Womb Technology (Yes, it’s coming)

Transcript

• 00:00Going to introduce doctor Mercurio,
• 00:02and we'll get started.
• 00:03So Mark Mercurio is, of
• 00:05course, a professor of, pediatrics
• 00:07and our founding director, now
• 00:09co director of the program
• 00:10for biomedical ethics at Yale
• 00:12School of Medicine and is
• 00:13also the founding director of
• 00:15the Yale Pediatrics ethics program
• 00:17at Yale new New Haven
• 00:18Children's Hospital.
• 00:19He was for many years
• 00:21chief of neonatal perinatal medicine
• 00:23at Yale, having stepped down
• 00:24from that role in twenty
• 00:26twenty two. He received his
• 00:27undergraduate degree in biochemical sciences
• 00:30from Princeton University,
• 00:32an MD from Columbia University,
• 00:34and he completed his pediatrics
• 00:35residency and neonatology
• 00:37fellowship
• 00:38here at Yale.
• 00:40After fellowship, he serves he
• 00:41served as an attending neonatologist
• 00:43at Yale and founding director
• 00:44of the newborn ICU
• 00:46at Lawrence and Memorial Hospital
• 00:47in New London, Connecticut.
• 00:49And he earned an MA
• 00:50in philosophy from Brown University
• 00:51before he returned to Yale
• 00:52full time afterwards.
• 00:54Doctor Mercurio has for many
• 00:56years been very active in
• 00:57the in neonatology and medical
• 00:59ethics education,
• 01:01for residents, fellows, nursing, attending
• 01:03physicians, PA students, medical students,
• 01:06as well as many others.
• 01:08He has been a member
• 01:09of the medical faculty for
• 01:10the fellowships at Auschwitz for
• 01:11the study of professional ethics,
• 01:12also known as FASB, since
• 01:14twenty ten. He's a former
• 01:16chair of the American Academy
• 01:17of Pediatrics section on bioethics
• 01:19and an original co editor
• 01:21of the American Academy of
• 01:22Pediatrics,
• 01:23resident curriculum in bioethics.
• 01:26He is a fellow of
• 01:27the Hastings Center and member
• 01:28of the American Pediatric Society.
• 01:29And in twenty twenty three,
• 01:31he received the William G.
• 01:32Bartolome Award for ethical excellence
• 01:34from the American Academy of
• 01:36Pediatrics.
• 01:37Mark, take it away.
• 01:43Alright. Playing a home game.
• 01:45So here, first
• 01:47First favorite out there because
• 01:49I think
• 01:51I have to look at
• 01:52it twice. It's a little,
• 01:53you know, a little excessive.
• 01:54Let's see if this works.
• 01:56Look at that. We're in.
• 01:58Well, thank you guys so
• 01:59much for coming out on
• 02:00a cold night. I I
• 02:01do think this is a
• 02:02fascinating subject, so,
• 02:04let me just get right
• 02:05to it. Artificial womb technology.
• 02:08And,
• 02:08I do think it's coming,
• 02:10and we will talk about
• 02:11that in more depth. So
• 02:12I appreciate it. I see
• 02:13a lot of a lot
• 02:14of friends who,
• 02:15who made the effort today,
• 02:16and I really appreciate it.
• 02:17Let's see if this works
• 02:17if I just do that.
• 02:18It does. So disclosures, I
• 02:20steal pictures from Google. I
• 02:21think you probably knew that
• 02:22already.
• 02:24So a quick overview of
• 02:25what we're gonna do tonight.
• 02:26We're gonna talk about extremely
• 02:28preterm birth. We're gonna talk
• 02:29about artificial womb technology,
• 02:31a little bit about the
• 02:32nuts and bolts, and then
• 02:33about research ethics guidelines.
• 02:36There's gotta be some ethics
• 02:38here. There is an ethics
• 02:39conference. We'll talk about some
• 02:40ethical considerations in using this
• 02:41technology,
• 02:43and then some questions I
• 02:44think need to be answered.
• 02:45And then there's gonna be
• 02:46time for your thoughts, which
• 02:47I'm very interested in hearing
• 02:49on this subject. So let's
• 02:50get to it. So first
• 02:52of all, this is what
• 02:52it looks like if you're
• 02:54inside a womb. So where'd
• 02:56Isaac go?
• 02:57Isaac.
• 02:59Why are we looking at
• 03:00that?
• 03:01There we go. And then
• 03:03we get this.
• 03:05Alright.
• 03:07Any questions?
• 03:08I think this is good.
• 03:09I think we'll use this
• 03:10instead of that. Alright. The
• 03:12picture's up there. Very good.
• 03:13Alright. So this is what
• 03:14it looks like on the
• 03:14inside. Right?
• 03:16The in utero support,
• 03:18what it's like for a
• 03:19fetus. And you can see,
• 03:20of course, you guys know
• 03:21this, that what did your
• 03:23mother provide you with warmth?
• 03:25You know, ninety eight point
• 03:26six, her body temperature rate,
• 03:27or close to it. It
• 03:29might actually be exactly like
• 03:30that.
• 03:32Nutrition via the umbilical cord.
• 03:33Of course, homeostasis.
• 03:35You remember
• 03:36as a fetus worrying about
• 03:38maintaining your serum sodium in
• 03:39the normal you don't remember
• 03:40that because you didn't have
• 03:41to do that because your
• 03:42mother took care of that.
• 03:43The placenta takes care of
• 03:44that. There's a fluid environment
• 03:45for growth, which is actually
• 03:47quite important. For example, the
• 03:48lungs can't develop unless there's
• 03:50an adequate fluid environment.
• 03:52Oxygenation
• 03:53from the placenta through the
• 03:54umbilical cord, of course, that's
• 03:55essential. And you can take
• 03:57a look for those of
• 03:57medical students
• 03:59recognize this as basically the
• 04:00fetal physiology.
• 04:02And to orient you, of
• 04:03course, we have the placenta
• 04:04and the blood coming
• 04:06from the placenta and up
• 04:07here into the right heart
• 04:09and crossing
• 04:10right to left at the
• 04:11foramen ovale and at the
• 04:12ductus arteriosus.
• 04:13Don't worry about this, but
• 04:15the the key point of
• 04:16this picture
• 04:17is that as a fetus,
• 04:19you don't really even need
• 04:20your lungs, and you don't
• 04:21send very much blood to
• 04:22your lungs. Little bit goes
• 04:24there so the lungs can
• 04:25grow and develop, but you
• 04:26don't need your lungs because
• 04:27that's not where the oxygen's
• 04:28coming from. Of course, you're
• 04:29underwater. The oxygen is coming
• 04:31from the placenta. So your
• 04:32mother provided you with all
• 04:34this, so the lesson is
• 04:36when you get home tonight,
• 04:37call your mother.
• 04:40Now let's see if we
• 04:41can get this. Okay. Now
• 04:42the transition to extrauterine life,
• 04:44which is the most fascinating
• 04:46hour of your life, and
• 04:47you don't remember that either.
• 04:48But we have to maintain
• 04:50as we made that transition,
• 04:51we had to maintain warmth,
• 04:53nutrition, homeostasis.
• 04:55Do we need that fluid
• 04:57environment for growth? Well, we
• 04:57really don't anymore, and, of
• 04:58course, it was lost. K?
• 05:00Do we need oxygenation? Of
• 05:01course, we do. We made
• 05:03that transition very quickly from
• 05:04the placenta
• 05:05to our own lungs. And,
• 05:07and this is all these
• 05:09things have to happen in
• 05:10this transition. And it's just
• 05:11fascinating
• 05:12that it usually goes right
• 05:14because it's pretty complicated. So
• 05:16all those things that were
• 05:17provided on the inside, so
• 05:18much of that is still
• 05:19needed on the outside. And
• 05:20the transition, as I say,
• 05:22is fascinating stuff, and some
• 05:23people, including some in this
• 05:24room, spend their whole life
• 05:26working on this. It's really
• 05:27interesting. And ninety percent of
• 05:29the time, it's it goes
• 05:30fine, by the way, if
• 05:31anybody here is waiting for
• 05:32their baby. It usually goes
• 05:34just fine. Now
• 05:35not always, though. Right? And
• 05:37in particular,
• 05:38sometimes the babies come out
• 05:39early. And I wanna talk
• 05:40a bit about the babies
• 05:42that come out very early,
• 05:43extremely preterm birth. All the
• 05:45systems that have to kick
• 05:47in
• 05:48have to kick in too
• 05:49soon. Okay? So the lungs
• 05:50which are needed for gas
• 05:51exchange, they're not really physiologically
• 05:53ready. Again, the students know
• 05:55that there's not adequate pulmonary
• 05:57surfactant to keep the lungs
• 05:58from collapsing. Yes.
• 06:01Oh, you were just waving.
• 06:03Oh, you said, alright. Well,
• 06:04it's good to see. Alright.
• 06:05So,
• 06:06there's not enough pulmonary surfactant,
• 06:08but there's also other structural
• 06:10immatures. The lungs are not
• 06:11ready, and this is often
• 06:12the limiting factor for how
• 06:14small a baby can survive.
• 06:16And the progress that's been
• 06:17made in the past half
• 06:18century of keeping these tiny
• 06:19babies alive, a lot of
• 06:21it has been about better
• 06:22and better ways to ventilate
• 06:23immature lungs, particularly at the
• 06:25borderline gestational ages of survival.
• 06:28Also, you don't have enough
• 06:29skin. You don't have enough
• 06:31subcutaneous
• 06:31fat to maintain body temperature.
• 06:33You don't have enough skin.
• 06:35The skin is not developed
• 06:36enough to keep the water
• 06:37on the inside. So these
• 06:38extremely short babies, if you
• 06:39put them out in the
• 06:40open room, they're gonna get
• 06:41cold very quickly, and they're
• 06:43gonna get dehydrated very quickly
• 06:44because of the evaporative water
• 06:45loss. Alright? Everything, the intestinal
• 06:48tract, on and on, all
• 06:49these systems here
• 06:51are not ready to come
• 06:52out. Nevertheless,
• 06:54the critical care,
• 06:56which means the staff and
• 06:57the technology, including some folks
• 06:58who are here tonight, critical
• 07:00care often
• 07:01saves these tiny babies. It's
• 07:03really quite remarkable.
• 07:06But at the very limits,
• 07:09which we'll call twenty two
• 07:10to twenty five weeks gestation,
• 07:12normal being thirty seven to
• 07:14forty one. We'll say forty.
• 07:15Right? So forty weeks is
• 07:16a ballpark for what normal
• 07:18gestation is. When kids are
• 07:19born between twenty two and
• 07:20twenty five weeks, that's considered
• 07:23borderline.
• 07:23There's substantial morbidity and mortality
• 07:27notable at these lowest gestational
• 07:29ages. Alright? And
• 07:30the fellows have heard me
• 07:32say, though I haven't been
• 07:33in the ICU this year,
• 07:34so they don't hear it
• 07:34as much, but I've spent
• 07:36many years teaching
• 07:37the rule number one and
• 07:38rule number two of neonatology.
• 07:40There's only five rules altogether.
• 07:41Someday, I'll tell all the
• 07:42medical students. Rule number one
• 07:44of of neonatology is that
• 07:45ventilators save babies.
• 07:47And rule number two of
• 07:48neonatology
• 07:49is that ventilators kill babies.
• 07:51Okay? It's a real problem
• 07:53when we take this immature
• 07:55lung and we expose it
• 07:56to the pressure from that
• 07:57ventilator. We expose it to
• 07:59extra oxygen. We get free
• 08:01radical damage. Right? We've got
• 08:02oxygen toxicity. We've got what
• 08:04we call volume trauma because
• 08:06we stretch out those lungs
• 08:07in ways that they can't
• 08:08really tolerate well. You see,
• 08:10even if you're not used
• 08:11to looking at X rays,
• 08:13you see the picture on
• 08:14the left of a normal
• 08:14chest X-ray, and you see
• 08:16the picture on the light.
• 08:17And, of course, the the
• 08:19area that's just mostly black
• 08:20or light gray, that's because
• 08:21it's mostly just air. But
• 08:23over here, you see all
• 08:24this white stuff. White stuff
• 08:25is the denser stuff. That's
• 08:27the this fibrosis,
• 08:29the scarring, if you will,
• 08:30in the lung and other
• 08:31areas of air trapping. The
• 08:33lungs can be horribly damaged.
• 08:35The earlier that baby is,
• 08:37the more likely it is
• 08:38that we're gonna have trouble
• 08:39with what we call bronchopulmonary
• 08:41dysplasia, which is essential
• 08:44essentially lung damage caused by
• 08:45the combination
• 08:47of extreme prematurity
• 08:49and positive pressure ventilation, which
• 08:51we have to do to
• 08:52keep them alive,
• 08:53and oxygen toxicity because we
• 08:56put them in extra supplemental
• 08:57oxygen. Right? And, again, some
• 08:58people in the room were
• 08:59thinking, I can't believe he's
• 09:00telling this stuff because it's
• 09:01so obvious. And other people
• 09:02in the room were thinking,
• 09:04I never heard this stuff.
• 09:05But, you know, that's we
• 09:06have this eclectic audience. That's
• 09:08part of the fun of
• 09:08this. We're gonna get to
• 09:10other interesting things, and I
• 09:11wanna build on this a
• 09:12bit. But it's important to
• 09:14remember that that the things
• 09:15we do damage these lungs
• 09:17terribly. And make no mistake
• 09:18about it. Some of these
• 09:19kids die from bronchopulmonary
• 09:21dysplasia.
• 09:22In addition,
• 09:24that extremely premature brain
• 09:27doesn't tolerate the fluctuations in
• 09:29oxygenation,
• 09:30the fluctuations in blood pressure,
• 09:32and recognizing these pictures is
• 09:34not so important as me
• 09:36telling you. And I wonder
• 09:37if this cursor shows up.
• 09:38Does it show up on
• 09:39there? Yeah. It does. So
• 09:41these are ultrasounds. And if
• 09:42you're really smart, you realize,
• 09:44look over here on this
• 09:45one, the blood is on
• 09:46one side, but in the
• 09:47in this picture, it's on
• 09:48the other side. So some
• 09:49of these don't line up.
• 09:51Don't worry about that. What
• 09:52we have is because of
• 09:53an immature structure of the
• 09:55brain, we have a tendency
• 09:56to bleed.
• 09:57Alright? And so that can
• 09:59lead to significant
• 10:00permanent brain injury.
• 10:02Moreover, even in the absence
• 10:04of bleeding, on the right,
• 10:05you see a phenomenon that's
• 10:06intraventricular
• 10:07hemorrhage, IVH.
• 10:10The more premature a baby
• 10:11is, the more likely they
• 10:13are to have that bleeding,
• 10:14to have damage because of
• 10:15lack of oxygen.
• 10:17On the right, you see
• 10:18a cartoon showing basically
• 10:20some areas that are darker.
• 10:22What's the point of that
• 10:23for us here? It's called
• 10:24periventricular
• 10:25leukomalacia.
• 10:26It's damage to the brain
• 10:27parenchyma
• 10:28just superior to the ventricles
• 10:30here, okay, around the ventricles.
• 10:32Brain damage from bleeding,
• 10:34from ischemic damage. And the
• 10:36more premature that baby is,
• 10:38the more likely they are
• 10:40to have that damage. Okay?
• 10:42So there it is. Everything
• 10:44you wanted to know about
• 10:45neonatology in in three easy
• 10:47minutes.
• 10:48But I want you to
• 10:48know that this picture is
• 10:50interesting. Right? But what's really
• 10:51interesting is what does it
• 10:52mean to the kid?
• 10:54What it means to the
• 10:55kid is that motor function
• 10:57can be injured
• 10:59permanently, and a child can
• 11:01be left, for example, with
• 11:02cerebral palsy. Cognitive function can
• 11:04be injured permanently. So these
• 11:06kids may have developmental delay.
• 11:07They may have low IQ
• 11:09excuse me, low IQ,
• 11:11learning disabilities.
• 11:12Some of these kids are
• 11:13gonna have autism. There's an
• 11:15increased risk of autism with
• 11:16these tiny babies.
• 11:17Lots of this trouble brought
• 11:19on
• 11:20by being on the outside
• 11:22too soon. Alright?
• 11:24For all the reasons we
• 11:25talked about. Now we'll get
• 11:27back to that, but let's
• 11:28do it this way.
• 11:30And let's talk about artificial
• 11:31womb technology, why you came
• 11:33here today. So what's the
• 11:34idea? The idea is that
• 11:36we wanna target those earliest
• 11:38gestational ages, twenty two to
• 11:40twenty four weeks maybe.
• 11:42Interestingly, those are when you
• 11:43see the ZPD.
• 11:44Those are in what have
• 11:45been called some by some,
• 11:47the zone of parental
• 11:49discretion.
• 11:50Now those of you who
• 11:51are interested in ethics may
• 11:52kinda get what that term
• 11:53means.
• 11:54And what that term means
• 11:55is this is an area
• 11:56where we give parents a
• 11:57lot of discretion
• 11:59about how aggressive we will
• 12:00or won't be in trying
• 12:01to keep this baby alive.
• 12:04K. So for example,
• 12:05a child who's born at
• 12:06twenty eight weeks, we don't
• 12:08really give the parents that
• 12:09much discretion. The chance of
• 12:10survival and a good outcome
• 12:12is so high that the
• 12:13general feeling within the profession
• 12:15and within the society is
• 12:16that this kid deserves a
• 12:17chance. We're gonna do our
• 12:18best to try and save
• 12:19this baby. We don't ask
• 12:20the parents, what do you
• 12:21think we should do here?
• 12:23On the other hand, a
• 12:23child who's born at twenty
• 12:24weeks,
• 12:25we don't think no matter
• 12:26what we do, when there's
• 12:27no evidence, no matter what
• 12:28we do, we can't save
• 12:29that child. And so we
• 12:30don't ask the parents, do
• 12:31you want us to do
• 12:32all these invasive and terribly
• 12:33difficult things to the child
• 12:34if we know it can't
• 12:35work?
• 12:36But in this range, twenty
• 12:38two to twenty four, we're
• 12:39in that zone of parental
• 12:40discretion, and it's directly relevant
• 12:42to our discussion
• 12:43of artificial
• 12:44womb technology.
• 12:45Okay? And the AWT is
• 12:47intended to reduce not just
• 12:49the high mortality that we
• 12:50see here, but also the
• 12:52high morbidity, which is to
• 12:53say the damage. And I've
• 12:54focused on the brain and
• 12:55the lungs. There's other things
• 12:57as well, but we can
• 12:58focus largely on the brain
• 12:59and the lungs that are
• 13:00likely to be injured.
• 13:02What's the idea? The idea
• 13:04is that when a kid
• 13:05is born,
• 13:06we're gonna put this kid,
• 13:08directly at the excuse me,
• 13:09young lady. There's seats right
• 13:10here in the front row
• 13:10if you'd like.
• 13:12Yeah. That's the one I
• 13:13can pick on her. She's
• 13:14been picking on me for
• 13:15forty three years. I can
• 13:16pick on her.
• 13:19So the idea is we
• 13:20can place this kid on
• 13:21the artificial womb for two
• 13:23to four weeks during that
• 13:25most vulnerable period, vulnerable to
• 13:27the to for death, vulnerable
• 13:28to lung injury, vulnerable to
• 13:30brain injury, just for a
• 13:31couple weeks. And then this
• 13:33kid when the kid comes
• 13:35out of that, this kid
• 13:36can be much more likely
• 13:37to survive and much less
• 13:39likely to have suffered permanent
• 13:40injury. Now importantly,
• 13:42gestational age is lower than
• 13:43this. The technology is simply
• 13:45not feasible, that the catheters
• 13:46can't get that small, for
• 13:48example. Okay? And also importantly,
• 13:51the people who have developed
• 13:52this technology
• 13:53have assured us the goal
• 13:55is
• 13:56not to lower the threshold
• 13:58at which we can save
• 13:59babies.
• 14:00The threshold
• 14:01is twenty two weeks, but
• 14:02really it's not. We can
• 14:03get into that in the
• 14:04end if you want. But
• 14:05right here, we're we're gonna
• 14:06get into some numbers for
• 14:08those of you who are
• 14:09not medically inclined. Sorry. We
• 14:10need to have some data
• 14:11in all this conversation.
• 14:13But that's the idea, is
• 14:14to try and reduce mortality
• 14:15and morbidity in that range,
• 14:18but not to lower the
• 14:19gestational age threshold. So how
• 14:21would this work?
• 14:23Well, the folks at,
• 14:25Children's Hospital of Philadelphia have
• 14:27developed something called Extend. This
• 14:29is not the only artificial
• 14:31womb technology that's being worked
• 14:33on. It is, I think,
• 14:34the most interesting and the
• 14:35most promising. And here you
• 14:36see, this is from a
• 14:37publication in two thousand seventeen.
• 14:40And this is when I
• 14:40first really learned about this,
• 14:42which is already now a
• 14:43little while away. Right? And
• 14:44so if we can if
• 14:46we get a look at
• 14:46this, we see what's happening
• 14:48here. This is obviously a
• 14:50a fetal lamb or a
• 14:51lamb,
• 14:53and this is delivered by
• 14:54c section. And right away,
• 14:56before this lamb even takes
• 14:57a breath, this lamb goes
• 14:58inside a plastic bag filled
• 15:00with fluid,
• 15:01an amniotic fluid substitute.
• 15:04Right? So so still inside
• 15:06that fluid environment, just like
• 15:07in the womb, the umbilical
• 15:09vessels are immediately hooked up
• 15:10to this oxygenator pump.
• 15:12Okay?
• 15:13Again, simulating, if you will,
• 15:15the placenta.
• 15:16So the placenta does all
• 15:17kinds of other stuff that
• 15:18this thing can't.
• 15:20Now the idea is that
• 15:21the blood is gonna get
• 15:23pumped out of here, pumped
• 15:24by
• 15:26the the lamb's own heart,
• 15:27and this was really the
• 15:28huge innovation. This is so
• 15:30low resistance. That's all it
• 15:31takes. Blood goes through here,
• 15:33gets oxygenated, and goes back
• 15:34in. If you look subtly,
• 15:36the cartoonist here show that
• 15:37this is redder blood coming
• 15:39out of this, pass this
• 15:40oxygen. And by the way,
• 15:41we can hang this IV
• 15:42bag here and feed in
• 15:44nutrients.
• 15:45Right? And by the way,
• 15:46you see over here, we
• 15:48can exchange that fluid periodically
• 15:50to keep that clean. But
• 15:51all this has to be
• 15:52kept very sterile.
• 15:53Right? So the the oxygenator
• 15:55to take the place, if
• 15:56you will, of the placenta,
• 15:58the the,
• 16:00this plastic bag called a
• 16:01bio bag
• 16:03to serve, as the as
• 16:04the amnion. Right? As the
• 16:06amniotic sac. And we have
• 16:07a very low resistance circuit.
• 16:09But this is obviously
• 16:10science fiction. Right? And this
• 16:12couldn't possibly actually work in
• 16:14real life, except if you
• 16:15take a look,
• 16:17it does.
• 16:18Okay? And this film is
• 16:20years old already.
• 16:21You see that little guy
• 16:23kicking around?
• 16:25So delivered by
• 16:27cesarean section.
• 16:29Immediately, the umbilical vessels are
• 16:30hooked up and placed into
• 16:32the bio bag.
• 16:35Gonna stay in there for
• 16:36two to four weeks when
• 16:37the lungs are at their
• 16:38most vulnerable. And the idea
• 16:39being that this gestational age
• 16:41of the lamb is supposed
• 16:42to correlate
• 16:43with about twenty twenty three
• 16:45to twenty four weeks in
• 16:46the human being, plus
• 16:50there. He's going around. Well,
• 16:52guess what happens? They keep
• 16:53him in there for two
• 16:54to four weeks,
• 16:56and then they deliver him.
• 16:58And now during those two
• 16:59to four weeks, what happened?
• 17:00Those lungs had further growth
• 17:02and development
• 17:03in that fluid environment.
• 17:05What happened? There were no
• 17:06fluctuations in blood pressure as
• 17:08much as there are when
• 17:09it's on the outside prematurely.
• 17:11There were no deep dips
• 17:12in oxygenation as it can
• 17:13happen when they're outside.
• 17:15So all these things mean
• 17:16that perhaps we've also protected
• 17:19the brain.
• 17:20It works.
• 17:21It's been shown to work,
• 17:23many times.
• 17:24It works in lambs. So
• 17:26what happened was,
• 17:29in just over a year
• 17:30ago, September of twenty twenty
• 17:31three, the FDA held a
• 17:33hearing for first in human
• 17:34trials.
• 17:35We've seen that it works
• 17:36in lambs. And by the
• 17:38way, some of these lambs
• 17:39can be sacrificed afterwards, and
• 17:41their brains examined under a
• 17:42microscope, and it appears
• 17:44that they look good and
• 17:45that lambs look good. But,
• 17:47obviously,
• 17:48what a what a lamb
• 17:49has to do neurologically
• 17:51is so much less complex
• 17:52than what we expect of
• 17:53the human brain over the
• 17:54course of life. But it
• 17:56looks good microscopically
• 17:57and clinically.
• 17:58Fantastic. So now the FDA
• 18:00is having a hearing
• 18:01in twenty twenty three about
• 18:02what's the deal we're gonna
• 18:03do first in human trials.
• 18:04And the folks from Children's
• 18:05Hospital of Philadelphia
• 18:07presented their data
• 18:08and talked about their technology.
• 18:10And I was asked to
• 18:11come and talk about the
• 18:12ethical concerns. Are there ethical
• 18:14concerns? Because I had written
• 18:15about that after that two
• 18:17thousand seventeen article. I was
• 18:18asked by that journal pediatric
• 18:19research, what do you make
• 18:20of this? And that's when
• 18:21I learned about it. I
• 18:22said, wow. This is amazing
• 18:23stuff. I mean, you can
• 18:24you can admit. You can
• 18:25agree. Seeing that lamb inside
• 18:27that bag is quite remarkable
• 18:29quite remarkable. So the question
• 18:31becomes,
• 18:32once it's been shown to
• 18:33be safe, feasible, and effective
• 18:35in animal studies,
• 18:36what questions should be answered
• 18:38before
• 18:39the first human is placed
• 18:41on artificial womb technology?
• 18:44Saw some considerations.
• 18:46Saw some some bread and
• 18:47butter pediatric ethics for us
• 18:49as we look at this
• 18:49stuff. So this is from,
• 18:51a fellow named Rick Kodesh
• 18:53who's out in Ohio, a
• 18:54well known pediatric ethicist
• 18:56who's asked a really important
• 18:58question. It's It's one that
• 18:59we always face with regard
• 19:01to pediatric
• 19:02research.
• 19:03Now remember, when we they
• 19:04didn't talk about first in
• 19:06human. The FDA wasn't asking
• 19:07about when do we just
• 19:08start doing this on babies
• 19:10because that's not the right
• 19:10way to do it, and
• 19:11I think most of you
• 19:12know this. The right way
• 19:13to do it is to
• 19:14study it. We need to
• 19:15do trials, controlled trials to
• 19:17see if this is actually
• 19:18better than standard therapy.
• 19:20So what Rick Kotash, tells
• 19:22us about how we approach
• 19:23we've got a vulnerable population,
• 19:25and I will tell you
• 19:26that always when we talk
• 19:27about research in babies, we're
• 19:28talking about a risk of
• 19:29exploitation.
• 19:30We got a very vulnerable
• 19:32population, and we've got two
• 19:33things that may be in
• 19:34conflict. One is the best
• 19:36interest of the child subject
• 19:37here of baby.
• 19:38The other is the potential
• 19:39benefit to science and to
• 19:41future babies, and these are
• 19:43in the balance.
• 19:44So which one should count
• 19:46for more?
• 19:47Well, what professor Kotich tells
• 19:48us, and I'm inclined to
• 19:50agree,
• 19:51is that individual beneficence must
• 19:53take precedence over collective notions
• 19:55of beneficence, and the pediatric
• 19:57research community
• 19:58must remember that our
• 20:00responsibilities to individual children
• 20:01outweigh more speculative concerns
• 20:04about potential benefits for future
• 20:06benefits excuse me, future
• 20:08generations
• 20:09of children. You may agree.
• 20:12You may disagree. You may
• 20:13think it's a bit of
• 20:13a threshold argument. Depends on
• 20:15how much the risk there
• 20:16is to the baby. Depends
• 20:17on how much benefit there
• 20:18are to future babies. We
• 20:19can get into that a
• 20:20bit. But there's a basic
• 20:22tenant, and I think he's
• 20:23right about that.
• 20:25Now you're thinking, shouldn't someone
• 20:27have rules about research on
• 20:29human subjects?
• 20:31Good news. There are rules.
• 20:33So the department of health
• 20:34and human services don't even
• 20:35get started. The department of
• 20:37health and human services
• 20:38has rules long standing rules
• 20:40called the common rule about
• 20:42research with human subjects. And
• 20:44in particular, there are areas
• 20:45about kids. And in particular,
• 20:47there's area about research involving
• 20:49with kids
• 20:50greater than minimal risk, but
• 20:52presenting the prospect of direct
• 20:54benefit to the individual subject.
• 20:56Because if we're experimenting with
• 20:57this technology, we take a
• 20:58kid who's got a high
• 20:59chance of dying, and we
• 21:00put him in that bio
• 21:01bag for a couple weeks,
• 21:02and he he might survive.
• 21:04He might benefit from participating
• 21:06in the trial. So So
• 21:07they give us three rules.
• 21:10First, we're gonna do this
• 21:11only if and these are
• 21:12ands, not ors. Three conditions.
• 21:14The first is the risk
• 21:15is justified by the anticipated
• 21:17benefits to the subjects.
• 21:19The second is the relation
• 21:20of the antitional benefits of
• 21:21the risk is at least
• 21:23as favorable
• 21:24as what's already available.
• 21:27Okay? And the third is
• 21:29adequate provisions are made
• 21:31for getting permission of the
• 21:33parents or guardians.
• 21:34These are our three requirements.
• 21:36So let's take a look
• 21:36at these one at a
• 21:37time. The first is about
• 21:39anticipated benefits to the subjects.
• 21:41One thing to remind you
• 21:42of, there's two research subjects.
• 21:45Right? Because we're talking about
• 21:46doing a cesarean section
• 21:48on someone who maybe not
• 21:49otherwise would have needed. We
• 21:50don't do c sections every
• 21:51time someone's gonna have a
• 21:52baby early. So this is
• 21:54someone who might not have
• 21:55needed a c section. Right?
• 21:56So the protocol could involve
• 21:57c section in a setting
• 21:59where otherwise would not have
• 22:00been clinically indicated.
• 22:01This poses risk to the
• 22:03pregnant patient and, by the
• 22:04way, risks to future pregnancies
• 22:07and risks to future babies
• 22:08that she might have. Right?
• 22:10So that's one of the
• 22:11research subjects. Now
• 22:13there's, of course, obviously, the
• 22:14risks and benefits to the
• 22:16baby as well.
• 22:17Now the second one, this
• 22:18is where a lot of
• 22:19the meat of this is.
• 22:19The relation of the anticipated
• 22:21benefit is at least as
• 22:22favorable as that presented
• 22:24by available alternative approaches. And
• 22:27here's where the data that
• 22:28was published by this research
• 22:29group where I took issue
• 22:31because they published some survival
• 22:32statistics that I think, frankly,
• 22:34were outdated.
• 22:35So I showed this current
• 22:36statistics of the f b
• 22:37a FDA,
• 22:39and I share some of
• 22:39that with you.
• 22:41So take a look at
• 22:41this, if you will. This
• 22:42is from the Neonatal Research
• 22:43Network, which is, like, twenty
• 22:45three, I think,
• 22:46academic
• 22:48centers in the in the
• 22:49United States who pool their
• 22:50data for purposes of research.
• 22:52And these are their and
• 22:53if you look at this,
• 22:54what you see is, the
• 22:55red box is what I
• 22:56want you to focus on.
• 22:57That's survival. Okay? Survival to
• 22:59discharge.
• 23:00Right? That's survival for twenty
• 23:01two weeks, twenty three weeks,
• 23:03twenty four weeks, and twenty
• 23:04five weeks. And what you
• 23:05see, for example, is survival
• 23:07at twenty two weeks.
• 23:09These data, of course, are
• 23:10old now. It's two thousand
• 23:11thirteen to two thousand eighteen,
• 23:13just published in two thousand
• 23:15twenty two.
• 23:16Because this is tricky because
• 23:17you also wanna know how
• 23:18they do a couple years
• 23:19later. So you can't publish
• 23:20last week's survival data and
• 23:22also have disability data.
• 23:24Tricky. So this is what
• 23:25we have to work with.
• 23:26Right? Ten percent survival at
• 23:28twenty two weeks, forty nine
• 23:30percent at twenty three weeks,
• 23:32sixty nine, just about seventy
• 23:34percent at twenty four weeks.
• 23:35So, for example, if we
• 23:36say, well, at twenty four
• 23:37weeks, the kid was probably
• 23:39gonna die if we didn't
• 23:40use this technology.
• 23:41Let's say, hang on. It
• 23:42looks like seventy percent of
• 23:43them survive.
• 23:44Well, at twenty two weeks,
• 23:46however,
• 23:47the survival is only ten
• 23:48percent.
• 23:49Right?
• 23:50Except it's not that simple.
• 23:52Because when they looked at
• 23:53all of these data,
• 23:55what they looked at, of
• 23:56course, was overall survival.
• 23:58And the tricky part is
• 23:59in those days, in that
• 24:00era, at twenty two weeks
• 24:02in particular,
• 24:03most of the time, we
• 24:04didn't even try to save
• 24:05them.
• 24:06There have been a been
• 24:06a conversation with the parents
• 24:07for whatever reason. So the
• 24:09relevant question is not what's
• 24:10the overall survival at twenty
• 24:11two weeks with current technology.
• 24:14The smart relevant question is,
• 24:16what would be the survival
• 24:17with current technology
• 24:19if we tried? And the
• 24:20answer to that is quite
• 24:21different. Look at the blue
• 24:22box. So you see ten
• 24:23percent up here in the
• 24:24red box. Hey. It's thirty
• 24:26percent when we try.
• 24:28And at twenty four weeks,
• 24:29it's forty nine percent overall,
• 24:31but fifty five percent when
• 24:32we try.
• 24:33And at twenty four and
• 24:34twenty five weeks, the numbers
• 24:36don't change because we almost
• 24:37always try.
• 24:39This is for major academic
• 24:40centers in the US. Okay?
• 24:42So let's focus just for
• 24:43fun on twenty two weeks
• 24:44right at the edge.
• 24:45Right? So we thought it
• 24:46was ten percent.
• 24:47Really, it's thirty percent.
• 24:50And and that, of course,
• 24:51is is those are very
• 24:52different numbers when we're saying,
• 24:53well, what are our chances
• 24:54of saving this kid,
• 24:56you know, with current technology?
• 24:58Now more recent stuff was
• 24:59published just a few months
• 25:01ago. The Vermont Oxford Network
• 25:03published their data. We participate
• 25:04in that. Six hundred and
• 25:06thirty six US hospitals. Okay?
• 25:08Here's our survival at twenty
• 25:09two weeks. Remember, we looked
• 25:10at it. It was ten
• 25:11percent overall, thirty percent
• 25:14if we tried. Well, they
• 25:15said, guess what? It's twenty
• 25:17five percent overall. This was
• 25:18a newer epic, two thousand
• 25:20twenty
• 25:21to two thousand twenty two.
• 25:22So they said, no. Actually,
• 25:24it's twenty five percent, but
• 25:25it's thirty six percent when
• 25:27we tried.
• 25:28Now we're up to thirty
• 25:29six percent. Alright. Well, now
• 25:31we know the real number.
• 25:32Right? And in fact, they
• 25:33also published this. Okay. It's
• 25:34thirty six percent at twenty
• 25:35two weeks. So you look
• 25:36at this bar graph that
• 25:37way, and this is survival.
• 25:39So we see survival at
• 25:40twenty two weeks was thirty
• 25:41six percent. By twenty three
• 25:42weeks, it was fifty five
• 25:43percent. So by twenty three
• 25:45weeks in the US,
• 25:47we save most.
• 25:49Say something more than half.
• 25:50Right? And by twenty four
• 25:51weeks, we save about three
• 25:53quarters. You see the seventy
• 25:54one percent.
• 25:55So that's important. When we're
• 25:57thinking about doing something
• 25:58pretty impressive
• 26:00like the bio bag, like
• 26:01the artificial womb, recognized, for
• 26:03example, at twenty four weeks,
• 26:04there's already a three out
• 26:05of four chance we could
• 26:06save this kid just with
• 26:07current technology.
• 26:08But we're looking at twenty
• 26:09two weeks right at the
• 26:10edge. Now this number is
• 26:11really thirty six percent. Well,
• 26:13stay tuned because guess what?
• 26:14The Japanese, who have always
• 26:16been very aggressive about this
• 26:17stuff and very good at
• 26:18it, they looked at their
• 26:19neonatal research network, and they
• 26:20said, well, when we get
• 26:21these kids to the NICU,
• 26:22when we really try, we
• 26:24save half of
• 26:25them at twenty two weeks.
• 26:27So the number was ten
• 26:28percent, never minus thirty percent,
• 26:30never minus thirty six percent,
• 26:31never mind it's fifty percent.
• 26:33Alright? Why aren't we having
• 26:34fun yet? How about Iowa
• 26:36right here in the US
• 26:37of A? These guys are
• 26:39super aggressive,
• 26:40and these guys are are
• 26:42really good at it as
• 26:43well. They have these specific
• 26:44protocols, a special
• 26:46special small baby team.
• 26:47They use a lot of
• 26:48antenatal steroids.
• 26:50The punchline is at twenty
• 26:52two weeks, they save two
• 26:53thirds
• 26:54at twenty two weeks. See
• 26:56that? Twenty two weeks gestational
• 26:58age of birth, twenty two,
• 26:59twenty three, and twenty four.
• 27:00And here you
• 27:01see survival to discharge, sixty
• 27:03four percent,
• 27:04eighty two percent, eighty nine
• 27:06percent. See. But over there,
• 27:08Brad Jubler, pediatrician extraordinaire, is
• 27:10saying to me, hey. But
• 27:11look at these numbers. These
• 27:13numbers are very low. This
• 27:14is a single center.
• 27:16This isn't as powerful as
• 27:17when we read a whole
• 27:18research network and there's hundreds
• 27:20of kids. This is very
• 27:21anecdotal. Right? And two or
• 27:22three good babies or two
• 27:23or three bad babies could
• 27:24throw this number in a
• 27:25in a significant direction. But
• 27:27this is roughly at Iowa,
• 27:29they say, we save two
• 27:31out of three. That was
• 27:32already published five years ago,
• 27:34and they're talking about a
• 27:35two thousand six
• 27:36to two thousand fifteen
• 27:39birth cohort. At twenty two
• 27:40weeks, current technology,
• 27:42they say they can save
• 27:43two thirds. And by the
• 27:45way, more recently, anecdotally,
• 27:47they say they can do
• 27:48better than that.
• 27:49Nagano Children's Hospital in Japan.
• 27:51Hey, man. Basically, we can
• 27:52save just about all of
• 27:53them.
• 27:54Okay. Twenty two weeks. Look
• 27:55at your gestational age, twenty
• 27:57two weeks.
• 27:58Survival's eighty one percent. But
• 27:59when they admit them to
• 28:00the NICU, the ones where
• 28:01they try, that's probably a
• 28:02good proxy for when we
• 28:03tried. Ninety three percent. So
• 28:05somewhere from eighty to ninety
• 28:06percent,
• 28:07they save.
• 28:08Again, a single center study,
• 28:11very low numbers. Interesting, but
• 28:14maybe not something to hang
• 28:15our hat on. Except now
• 28:16we have another place that
• 28:17says we can save nearly
• 28:19all of them at twenty
• 28:20two
• 28:21weeks.
• 28:23That's crazy because everybody knows
• 28:24that survival at twenty two
• 28:26weeks is impossible. Believe me.
• 28:27I was raised on that.
• 28:28But like a lot of
• 28:29things that are impossible, turns
• 28:31out not to be the
• 28:31case.
• 28:32Right? Now
• 28:34this is something that the
• 28:35clinicians in the room know
• 28:36very well, but the students
• 28:38need to learn and others
• 28:39in the room would be
• 28:40interested in, that it's not
• 28:41just about gestational age. Okay?
• 28:44So, in fact, we have
• 28:45this, predictor tool we can
• 28:46use by putting in other
• 28:47factors. So take a look
• 28:49at this, the likelihood of
• 28:50survival if we try.
• 28:52At twenty two weeks,
• 28:53a boy and by the
• 28:54way, the older you are,
• 28:56the better you do. The
• 28:57girls do better than the
• 28:58boys. Bigger does better than
• 29:00smaller. Singletons do better than
• 29:01twins, and if you get
• 29:02steroids, you do better than
• 29:03if you didn't. That's true
• 29:05for just about everything. That's
• 29:06another conversation. Alright. So
• 29:08look at this. If the
• 29:09mother gets steroids, to be
• 29:11specific, before delivery.
• 29:12So twenty two weeks small
• 29:14boy, fifteen percent chance. Twenty
• 29:16two weeks, slightly larger girl,
• 29:18singleton, got steroids, forty four
• 29:20percent chance. A threefold difference.
• 29:22So when we just talk
• 29:23about gestational age,
• 29:25that's an inappropriate
• 29:27proxy
• 29:28for prognosis, but it's still
• 29:30widely used. There's marked variation
• 29:32in prognosis
• 29:33within a certain gestational age,
• 29:35and gestational age alone is
• 29:37a poor
• 29:38proxy for prognosis.
• 29:40Important when we're trying to
• 29:41figure out which patients
• 29:43should go onto the artificial
• 29:45womb or into
• 29:47the artificial womb. Right? Trying
• 29:49to figure out what are
• 29:50the chances this kid would
• 29:51have survived just with the
• 29:52things we already have
• 29:54It's not so simple.
• 29:56Now
• 29:57this outcome is used. This
• 29:59special tool that we have
• 30:00is a statistical tool. It's
• 30:02available online that predicts, but
• 30:04it's it's widely used here
• 30:06and elsewhere to to give
• 30:07prognosis.
• 30:08But it's important to know
• 30:10that it's based on data
• 30:11from nineteen ninety eight to
• 30:12two thousand three, from a
• 30:13generation ago. The thing is
• 30:15on the computer now that
• 30:16we're using,
• 30:17and it doesn't account for
• 30:19the substantial variation,
• 30:21in US hospitals.
• 30:23So remember we're talking about
• 30:25we should only use this
• 30:26if it's got a better
• 30:27chance. The the anticipated benefit
• 30:30to the risk is at
• 30:31least as favorable as what's
• 30:32already available.
• 30:35Now
• 30:36this brings us to a
• 30:36really interesting and difficult question
• 30:38as we try and ask
• 30:39the ethical questions. What survival
• 30:41data and currently available technology
• 30:43should be used for determination
• 30:45of relative risk? Right? We're
• 30:47talking about the overall US
• 30:48data, the neonatal research network
• 30:50that said, you know, thirty
• 30:52percent survival. The Vermont Oxford
• 30:54network said thirty six percent
• 30:56survival. The centers with the
• 30:57best outcome that say eighty
• 30:59to ninety percent survival. I'm
• 31:00just talking about twenty two
• 31:01weeks.
• 31:02That's a big difference when
• 31:03we're counseling parents, for example,
• 31:06to get informed consent for
• 31:07this study.
• 31:09Should it be based on
• 31:10tater where the where the
• 31:11where the artificial womb technology
• 31:14is to be trialed? So
• 31:15can the folks at Philadelphia
• 31:16say, well, here, we can't
• 31:17save twenty two weekers at
• 31:18all. So, clearly, we should
• 31:20just put these kids in
• 31:20the bio bag because they
• 31:22all die even though
• 31:24across town, maybe someone's saving
• 31:26half of them or more.
• 31:27That doesn't make a lot
• 31:28of sense, does it? So
• 31:30should a trial center first
• 31:31emulate centers
• 31:33with best outcomes before trying
• 31:35artificial womb technology?
• 31:37And,
• 31:38there's a couple people in
• 31:39the room that know very
• 31:40well that we went down
• 31:41this path before a generation
• 31:43ago, and I'll get to
• 31:44that. Because it seems odd
• 31:46for one center to say,
• 31:47these babies all die, so
• 31:48we can try something extraordinary.
• 31:50When other centers say, we
• 31:51can save most of these
• 31:52babies.
• 31:55These questions have to be
• 31:56answered before the first human
• 31:57being goes into that bio
• 31:59bag as part of a
• 31:59trial or otherwise.
• 32:02But it's not just about
• 32:03survival anyway. Right? Let's not
• 32:05forget
• 32:06that its outcome is also
• 32:07about morbidity, about the injury
• 32:09we talked about early on,
• 32:10about some kids who are
• 32:11left with really rough cerebral
• 32:13palsy, significant cognitive injury, also
• 32:16visual deficits, hearing deficits, autism,
• 32:18so many problems these kids
• 32:20can have,
• 32:21and the pulmonary issues. Right?
• 32:23So
• 32:24maybe we could make this
• 32:25better if we put those
• 32:26lungs inside the bile bags
• 32:27for a month before we
• 32:29expose them to pipe, the
• 32:30two
• 32:31positive pressure ventilation, before we
• 32:33pushed on them every every
• 32:35two seconds
• 32:36for a couple of weeks.
• 32:38Maybe we could reduce that
• 32:39pulmonary embitter. The same thing
• 32:40with the brain. If we
• 32:41kept the brain in that
• 32:42calmer environment, maybe that could
• 32:44be better.
• 32:45So we've got the short
• 32:46term evidence about survival we
• 32:48can compare, but, of course,
• 32:49hard term
• 32:50benefit of this technology
• 32:52is so much harder to
• 32:53assess. So we measure the
• 32:55stuff that's easy to measure,
• 32:56and we love it. So
• 32:57we said, look. We did
• 32:58an ultrasound, and we showed
• 32:59interventricular hemorrhage. Good. We can
• 33:01look at it a week,
• 33:02and we can say, look.
• 33:02Yes. There was a bleed
• 33:03inside the brain. Cool. We
• 33:04can look with an ultrasound
• 33:06in a week and tell
• 33:07you that.
• 33:08That's a lot easier than
• 33:10figuring out what the kid's
• 33:11gonna be like in first
• 33:13grade or beyond that. And
• 33:15I can promise you this,
• 33:16unless one of you guys
• 33:17has some really cool technology,
• 33:19no one knows for sure
• 33:20what this kid's gonna be
• 33:20like in the first grade
• 33:21until
• 33:22he's in the first grade.
• 33:23And unless he's really advanced,
• 33:25that ain't happening in seven
• 33:26days. Right? So there's this
• 33:28big lag time in trying
• 33:30to figure this out. It's
• 33:31really problematic.
• 33:33So what matters to the
• 33:34kids? What matters to the
• 33:36parents is not what the
• 33:37head ultrasound looks like, is
• 33:39not the stuff we can
• 33:40measure. The head ultrasound
• 33:42is only interesting
• 33:44insofar as it helps us
• 33:45treat the kid, and it
• 33:46usually doesn't.
• 33:48But it's really in so
• 33:49interesting insofar as it helps
• 33:50us predict
• 33:52the degree of injury this
• 33:53child will be left with.
• 33:55Because what do you really
• 33:56care about if you're the
• 33:56parents of a tiny baby?
• 33:58You care about how's this
• 34:00kid gonna do on the
• 34:01playing field, and how's this
• 34:02kid gonna do intellectually,
• 34:04cognitively.
• 34:05Right? And what you really
• 34:06care about if you're thinking
• 34:07about it is how much
• 34:08is this child gonna enjoy
• 34:09his life.
• 34:10Right? And these things are
• 34:12related, but not necessarily determinative,
• 34:13which is obviously that a
• 34:15child could have a significant
• 34:16disability
• 34:17and still get a lot
• 34:18of pleasure out of life.
• 34:20So these are complicated questions,
• 34:21but bear in mind that
• 34:22it's about survival, but it's
• 34:24also about morbidity and disability.
• 34:27So we do have some
• 34:28data with regard to disability.
• 34:29Let's look at again once
• 34:31again, the, neonatal research network
• 34:33from that same paper I
• 34:34was quoting earlier from twenty
• 34:36twenty two, but bear in
• 34:37mind that's from patients born
• 34:39two thousand thirteen
• 34:40to two thousand eighteen. Well,
• 34:42look here. Look at these
• 34:42bar graphs. So on the
• 34:44y axis, you see oh,
• 34:45hope you guys got all
• 34:46that because it was fast.
• 34:48And now we're out.
• 34:55That ain't good. Now we're
• 34:57gonna ask Isaac to come
• 34:58back. This usually doesn't,
• 35:00go this way. Let's try
• 35:01this. How about if we
• 35:02do that? That worked. Alright.
• 35:04We're back in. Thank you,
• 35:05sir. Good job.
• 35:08Take a look at the
• 35:09bar graph. On the y
• 35:10axis, we have
• 35:11the percent of children from
• 35:13zero to a hundred. And
• 35:14on the x axis, we
• 35:15have these bar graphs. And
• 35:16I wanna focus in on
• 35:17the red box on the
• 35:18kids at twenty three twenty
• 35:19two, twenty three, and twenty
• 35:20four weeks at birth.
• 35:22Okay? Now
• 35:24the dark is the severe
• 35:25neurodevelopmental
• 35:26impairment. We're talking about cognitive
• 35:28cerebral palsy, vision, and hearing.
• 35:30That's what's being measured.
• 35:31And the middle the medium
• 35:33bar is moderate impairment, and
• 35:34the light bar is mild
• 35:35or no impairment.
• 35:37Okay? We take a look
• 35:38at twenty two weeks, for
• 35:39example, and we see that,
• 35:41you know, maybe half these
• 35:42kids have no or mild
• 35:43impairment.
• 35:44But look at the end.
• 35:45Right? Twenty nine kids either
• 35:47at this network. It's not
• 35:48a lot of kids.
• 35:49As soon as we get
• 35:50to twenty three weeks, suddenly,
• 35:52it's two hundred and eighty
• 35:53four
• 35:54kids. That's a lot of
• 35:55kids, and it's roughly a
• 35:56third in each category. And
• 35:58at twenty four weeks, roughly
• 35:59a third in each category.
• 36:00But you see as we
• 36:01go up in gestational
• 36:03age, the percentage of kids
• 36:04with no or mild neurodevelopmental
• 36:06impairment
• 36:07Okay. With no or mild
• 36:09neurodevelopmental
• 36:10impairment
• 36:11thank you. I'm sorry. Continue
• 36:12there we go. Hang on
• 36:13to that. That's good.
• 36:14It continues to go up.
• 36:16But these are the ones
• 36:17we're focused on.
• 36:18Right? These are the ones
• 36:19we're focused on, but it's
• 36:21an important thing about this,
• 36:23which is that this is
• 36:25follow-up
• 36:26at two years.
• 36:27And that's what we look
• 36:28at. And this is how
• 36:29we counsel parents that
• 36:31that cognitive that,
• 36:33prognosis tool that we all
• 36:34use online,
• 36:35that's based on two year
• 36:37outcomes. Okay?
• 36:39Now the folks at Japan,
• 36:40by the way, their network,
• 36:42fifty two tertiary centers, they
• 36:44take a look and they
• 36:45say at twenty two weeks,
• 36:47roughly half these kids have
• 36:48neurodevelopmental
• 36:49impairment.
• 36:50K? Now it's very commonly
• 36:51felt
• 36:52incorrectly
• 36:53that all these kids are
• 36:54left with devastating impairment or
• 36:56almost all of them. They're
• 36:57not. Maybe a third, a
• 36:58third, a third, maybe roughly
• 37:00half the kids have no
• 37:01impairment.
• 37:02I'm trying to give you
• 37:03just an order of magnitude.
• 37:04Okay? And, again, we're still
• 37:06talking here about two hundred
• 37:07and seventy one kids, and
• 37:08that's something.
• 37:09Okay?
• 37:11But that's still not huge
• 37:12numbers, but it gives us
• 37:13some order of magnitude. The
• 37:15folks at Iowa, they say
• 37:16no or mild impairment in
• 37:18more than half. At twenty
• 37:19two weeks, fifty five percent
• 37:21have no or mild impairment.
• 37:23But remember, that's at eighteen
• 37:24to twenty two months. And
• 37:26the
• 37:27NICHD, the neonatal research network
• 37:29data that we all use,
• 37:32it's based on follow-up at
• 37:33eighteen to twenty two months
• 37:34for around two years.
• 37:37But it's been a generations
• 37:38since Maureen Hack out in
• 37:40Ohio showed
• 37:42that that's not enough time
• 37:44to figure out how injured
• 37:45the kid's gonna be.
• 37:47So she said, well, if
• 37:48we look at these kids,
• 37:49these were these were not
• 37:50the tiniest babies what we'd
• 37:51call today, because this is
• 37:52like I said, this was
• 37:53published in two thousand five.
• 37:55So she's looking at kids
• 37:56from the nineteen eighties and
• 37:57nineties. Right? And she's showing
• 37:58that the very low birth
• 37:59weight newborns, if you look
• 38:00at them at twenty months,
• 38:02thirty nine percent have moderate
• 38:04to severe
• 38:05cognitive impairment. But look at
• 38:07those same kids at eight
• 38:08years, and that number is
• 38:09less than half.
• 38:11But still now, we are
• 38:12counseling parents and each other
• 38:14based on two year outcomes
• 38:15because that's how we do
• 38:16it, because we don't have
• 38:18to wait as long to
• 38:19find out. Bear in mind
• 38:21that that's probably overly pessimistic
• 38:23in terms of severe impairment.
• 38:25Then again, it's too soon
• 38:27to know about some other
• 38:27things like learning problems,
• 38:29like autism.
• 38:31Okay? So those two year
• 38:32outcomes
• 38:33are dicey, but that's still
• 38:34what's commonly used.
• 38:36Now there's something else. We've
• 38:38talked about whether you die.
• 38:40We've talked about whether you're
• 38:41left with disabilities.
• 38:42There's another thing.
• 38:44Pain may actually influence the
• 38:45development of the brain.
• 38:48Okay? Now
• 38:49we take a look at
• 38:50these three individuals,
• 38:52two human, one nonhuman,
• 38:54it looks to me this
• 38:55one getting a heel stick,
• 38:56and we don't do heel
• 38:57sticks on babies, in the
• 38:58newborn intensive care unit except,
• 39:00like, every hour. I mean,
• 39:01it's just that they get
• 39:02a lot of heel sticks.
• 39:04Okay?
• 39:05And just being on the
• 39:06outside, when you were supposed
• 39:07to be in a nice
• 39:08bag of body temperature water,
• 39:10just being on the outside
• 39:11could be a pretty unpleasant
• 39:12experience to be constantly being
• 39:14manipulated,
• 39:15get, you know, lots of
• 39:16needles, lots of tubes.
• 39:18It's it can't be a
• 39:19pleasant existence.
• 39:21Now this may influence brain
• 39:22development. It looks to me
• 39:24I can't prove it to
• 39:24you. It looks to me
• 39:26that this individual
• 39:27looks remarkably like a lamb,
• 39:28not a human being. This
• 39:30individual is having a more
• 39:31relaxed experience. No needles.
• 39:33Okay? No fluctuations in temperature.
• 39:35No being handled. I'm sitting
• 39:37here in this bag of
• 39:38water for a month.
• 39:39Okay?
• 39:40It's not a bad way
• 39:41to live. Now
• 39:42I can't prove that that's
• 39:43a more pleasant existence than
• 39:45this, but think about the
• 39:46possibility. What's interesting is we
• 39:47talk about pain in terms
• 39:49of how it affects brain
• 39:50development. But this is an
• 39:51ethics seminar, so I want
• 39:52you to think about pain
• 39:53in another way too. I
• 39:55want you to ask yourself,
• 39:56even if it doesn't affect
• 39:57brain development,
• 39:59does it matter
• 40:00that a baby suffers pain?
• 40:03Even if the baby doesn't
• 40:04remember pain when he's three
• 40:05years old, boy, that really
• 40:06hurt when I was a
• 40:07newborn. Even if someone doesn't
• 40:08remember pain, I wanna suggest
• 40:10to you that anybody, whether
• 40:11it's a baby or whether
• 40:12it's an adult in the
• 40:13last day of life, who's
• 40:14not gonna remember anything,
• 40:16even if someone doesn't remember
• 40:17their pain or someone who's
• 40:18just perioperative
• 40:19and they experience pain, then
• 40:21someone gives them a medication
• 40:22so they don't remember it.
• 40:23Anybody's pain matters,
• 40:25including
• 40:26the baby's pain. Alright? I
• 40:28think that,
• 40:29has a significant interest. And
• 40:30the technology, the point being,
• 40:32has the potential
• 40:33to reduce the pain.
• 40:35Alright. The third requirement that
• 40:37we need before
• 40:38the common rule tells us
• 40:39we can try this technology
• 40:41out on humans, adequate provisions
• 40:43are made for
• 40:44informed consent, informed permission of
• 40:46the parents.
• 40:47So this is very interesting.
• 40:48Right? Because here's how we
• 40:50get consent. And my friend
• 40:51Sarah knows this, and the
• 40:52neonatologist
• 40:53know this. This is this
• 40:54is how it works. We're
• 40:55gonna have a life and
• 40:57death conversation about your child,
• 40:59And we're gonna do it
• 41:00with someone who has been
• 41:01awake for thirty six
• 41:03hours, is in terrible pain,
• 41:06and is completely exhausted, and
• 41:08is scared out of her
• 41:09mind. Alright. Let's have a
• 41:10life and death conversation. Well,
• 41:12between contractions, we'll do it.
• 41:13We'll talk for a couple.
• 41:15Now it doesn't usually happen
• 41:16that way, but it often
• 41:18happens that way. That's the
• 41:19setting where we get permission
• 41:20to do things for babies.
• 41:22Should we or should we
• 41:22not attempt resuscitation?
• 41:24You might think, that's nuts.
• 41:25And I would say having
• 41:26done that for forty years,
• 41:28it is.
• 41:29We don't have a whole
• 41:30lot of choice except to
• 41:31just impose our will on
• 41:32the situation without even checking
• 41:34with the mother. That doesn't
• 41:35seem quite right either.
• 41:37Right?
• 41:38So
• 41:39aside from the mode of
• 41:40delivery, by the way, in
• 41:41terms of doing a c
• 41:42section on the pregnant patient,
• 41:44this is an easy one.
• 41:45We can have a whole
• 41:46hour on it, students, but
• 41:47for now, just take my
• 41:48word for it. We're not
• 41:49gonna do that without her
• 41:50permission. We don't care who
• 41:51thinks it's a good idea.
• 41:52It's not gonna happen without
• 41:53her permission. Okay? Aside from
• 41:55that,
• 41:57who has to give consent
• 41:58for this artificial womb technology?
• 42:00One parent, both parents?
• 42:02Whose permission is needed to
• 42:03take the kid out? Because
• 42:04most clinical trials, right, at
• 42:06any point, you're free to
• 42:07withdraw.
• 42:07So the kid is inside
• 42:09that bag. At some point,
• 42:10he's in there for a
• 42:11week. Everything's going well. And
• 42:12then the mother says, take
• 42:14him out. And the father
• 42:15says, don't do that.
• 42:17You gotta be prepared for
• 42:18your plan, and you need
• 42:19to be prepared for your
• 42:20plan. I suggest not when
• 42:21we've got a kid who's
• 42:22been in the bag for
• 42:23a week. These are conversations
• 42:24we need to have to
• 42:25have
• 42:26before
• 42:27first in human trials.
• 42:28Now we're gonna go out
• 42:30there a little bit. Okay?
• 42:30And we're gonna because this
• 42:31is ethics, so we gotta
• 42:32go out there a little
• 42:33bit. So let's talk about
• 42:34words because words matter. What
• 42:36do we call that individual
• 42:38on the artificial womb technology?
• 42:40Is it a fetus?
• 42:42Is it a neonate?
• 42:44Interestingly enough, in that first
• 42:45article about this,
• 42:47sometimes they were called they
• 42:48called it a fetal lamb,
• 42:50and sometimes they called it
• 42:51a neonatal lamb. The people
• 42:53who developed this technology and
• 42:54were using it on animals
• 42:56really weren't clear. One philosopher
• 42:58says, well, we're gonna give
• 42:58it a new name. We're
• 42:59gonna call it a just
• 43:00state link.
• 43:01And the people who developed
• 43:02the technology said, well, that's
• 43:03stupid.
• 43:05You know, and that we
• 43:07shouldn't give it a new
• 43:07name. And then a couple
• 43:08years later, they said, we're
• 43:09giving it a new name.
• 43:10We're calling it a.
• 43:12Alright? So you guys can
• 43:14decide. Maybe there'll be a
• 43:15competition to see who can
• 43:16name what this entity is.
• 43:17Who cares?
• 43:19Ah, you should care. Right?
• 43:21You should care because
• 43:23moral status is sometimes
• 43:25determined
• 43:25or influenced by what we
• 43:27call something
• 43:28or someone. Right? How a
• 43:30moral status is defined by
• 43:32the philosopher,
• 43:33Mary Ann Warren, is how
• 43:34much an individual's interest should
• 43:36count.
• 43:37Alright?
• 43:38We generally agree that a
• 43:39human being has a higher
• 43:40moral status than a cat,
• 43:42which has a higher moral
• 43:43status than a rock. Okay?
• 43:45How much an individual's interests
• 43:47or or welfare counts? That's
• 43:49the moral status. What's gonna
• 43:51be the moral status of
• 43:52this thing? The same as
• 43:53what we assign to a
• 43:53fetus, what we assign to
• 43:55a neonate,
• 43:56something in between.
• 43:57There's legal issues. There's cultural
• 43:59issues. There's ethical considerations.
• 44:02I hate to say it,
• 44:03but this stuff has to
• 44:04be worked out, really thought
• 44:05about before we do this
• 44:07on human beings.
• 44:10Now the good news is
• 44:11there's some analogy here. And
• 44:12this remember,
• 44:14students of ethics, we like
• 44:15this. We like kazoo history.
• 44:16We say, well, how are
• 44:17we gonna solve this? Well,
• 44:18do we have an analogous
• 44:19case that we've already solved?
• 44:21And, indeed, we have. Right?
• 44:22What you see on the
• 44:23left is your favorite technology,
• 44:25which is the extend technology.
• 44:27Right? That's our artificial womb.
• 44:28That's the limb. On the
• 44:29right, you see extracorporeal
• 44:32membrane oxygenation, which is a
• 44:33technology that's been in use
• 44:35for
• 44:36thirty some years,
• 44:37in Connecticut and forty years
• 44:39overall.
• 44:40And, basically, it'll look familiar
• 44:41if you look at it.
• 44:42I'm gonna use the cursor
• 44:43hopefully without losing my slide.
• 44:44But what basically you see
• 44:45is that these two catheters
• 44:47are put in the heart.
• 44:48This is a big full
• 44:49term baby, not a tiny
• 44:50preemie. This is a full
• 44:51term baby whose lungs simply
• 44:53cannot oxygenate
• 44:55for a while, not permanently,
• 44:57but maybe we need a
• 44:58week for these lungs to
• 44:59get out of some serious
• 45:00disease.
• 45:02So we put a catheter
• 45:03here. We drain some blood
• 45:04out. We pump it past
• 45:05an oxygenator. Oops. Excuse me.
• 45:07We pump it past an
• 45:08oxygenator,
• 45:09and we put it back
• 45:10in.
• 45:11See, again, the nice red
• 45:12stuff. K. We put it
• 45:13back in. We've got this
• 45:15external oxygenator. We've done this.
• 45:17So we've got a sort
• 45:18of analogy except it's a
• 45:19full term instead of a
• 45:20preterm baby.
• 45:22And what do we call
• 45:24it? We don't call it
• 45:25a fetonate because it's a
• 45:26lot like that fetal circulation
• 45:28that you saw at the
• 45:29very beginning. That's why I
• 45:30showed you the picture where
• 45:31we're really bypassing the lungs
• 45:33for the most part to
• 45:34some external thing that oxygenates
• 45:37the blood.
• 45:38Right? It's a lot like
• 45:39a fetus,
• 45:41but we don't agonize over
• 45:42what we call this thing.
• 45:43We call this thing
• 45:45a neonate
• 45:46on ECMO.
• 45:48Now interestingly enough, little known
• 45:50fact,
• 45:51the first time this was
• 45:52done in Connecticut,
• 45:53I was actually the the
• 45:55the physician who did it.
• 45:57I ran the whole thing.
• 45:59And,
• 46:00okay, that's not entirely true.
• 46:02I I was never near
• 46:03the kid. But
• 46:06interestingly enough, the physician who
• 46:07did
• 46:08put the first patient on
• 46:09ECMO in the state of
• 46:10Connecticut is actually here. So
• 46:12the pediatric ethics program salutes
• 46:14doctor Steve Peterick, who started
• 46:16ECMO in Connecticut, who start
• 46:18yeah. Go ahead. Clap. Don't
• 46:19be afraid to clap.
• 46:22So it's been
• 46:24forty years plus thirty five
• 46:25years since we've done it
• 46:26here in Connecticut, and we
• 46:27don't agonize over what to
• 46:29call that child. We call
• 46:30it a child. Should it
• 46:31be different? Because
• 46:33what this extend is, and
• 46:35the brilliant people that developed
• 46:37it probably wouldn't like me
• 46:38saying it. Man, it's ECMO
• 46:39in a bag. Okay? That's
• 46:41essentially what we're doing. Now
• 46:43it's really,
• 46:44not that hard as you
• 46:45can kinda tell from this
• 46:47picture.
• 46:48Alright? This is technologically
• 46:50not simple. In theory, if
• 46:52you look back at that
• 46:53picture I'm afraid of losing
• 46:54things. If you look at
• 46:55this cartoon, in theory, it's
• 46:57really not complicated at all.
• 46:59But in reality, making it
• 47:01work is incredibly labor intensive,
• 47:03requires a great deal of
• 47:04expertise. I taught him everything
• 47:05he knows. So this is
• 47:08this is not easy, but
• 47:09it's doable. So when we
• 47:10look at this, we say,
• 47:12this is gonna be hard.
• 47:13It looks easy in the
• 47:14cartoon. It's gonna require a
• 47:15lot of people,
• 47:16you know, for a while,
• 47:18while that's while we're using
• 47:19the technology, so does what
• 47:20we already use. So does
• 47:22what we already use.
• 47:23So that said,
• 47:25we can do this. What
• 47:26is interesting about this picture,
• 47:27which I think I got
• 47:28from Steve, actually, what's interesting
• 47:30about this picture is there's
• 47:31no
• 47:32people except for the baby.
• 47:34Right? So you put the
• 47:35kid in the room all
• 47:35by himself. Right? Well, I'm
• 47:37sure what happened in this
• 47:37picture was when Steve probably
• 47:39shot this picture. He said,
• 47:40alright. Everybody just step aside
• 47:42for two seconds so I
• 47:43can take this picture because
• 47:44there's plenty of people in
• 47:45the room all the time.
• 47:46Okay? When those first kids
• 47:48were on, doctor Pedic was
• 47:49in the room all day
• 47:50and all night and all
• 47:52the next day. It's hard
• 47:53work. But guess what?
• 47:56We do hard.
• 47:57We do hard. That's not
• 47:58a reason not to do
• 47:59this.
• 48:01Now, by the way, we
• 48:02talked about lowering the threshold
• 48:04for attempted resuscitation.
• 48:05Well, twenty two weeks is
• 48:06as low as you can
• 48:07go to keep someone alive.
• 48:09Everybody knows it's impossible for
• 48:10a human being to be
• 48:11kept alive ex utero, young
• 48:13within twenty two weeks. But
• 48:15like a lot of things
• 48:16everyone knows, turns out not
• 48:17to be true. Here's the
• 48:18first published report from an
• 48:20academic center of a kid
• 48:21born at twenty one weeks,
• 48:23four hundred and ten grams.
• 48:24That's couple ounces shy of
• 48:26a pound, let you know.
• 48:28And this kid at twenty
• 48:29four months was doing fine.
• 48:32And by the way, the
• 48:32folks in Iowa have a
• 48:34series of several. They now
• 48:36not infrequently,
• 48:38attempt resuscitation
• 48:39at twenty one weeks. And
• 48:40that is and I said,
• 48:41look at my funeral here
• 48:42with one of my obstetric
• 48:43colleagues. Looks like she's gonna
• 48:44lose her mind. But that
• 48:46that happens, and and and
• 48:48I'll get back to you
• 48:48because I was invited to
• 48:49come out there and give
• 48:50grand rounds, give obstetrics grand
• 48:52rounds while people talk about
• 48:53this. And
• 48:55the line continues
• 48:57to move like it or
• 48:58not.
• 48:59So what does this mean?
• 49:01To me, this means that
• 49:02even though the goal is
• 49:03not to lower the gestational
• 49:04age threshold with this new
• 49:06technology,
• 49:07sooner or later, a parent
• 49:08is gonna ask us to
• 49:09do it. Sooner or later,
• 49:11someone is gonna be in
• 49:11labor at twenty one and
• 49:12a half weeks, and we're
• 49:14gonna say this baby is
• 49:14gonna be born today, and
• 49:16I'm sorry there's nothing we
• 49:17can do. And it's gonna
• 49:18be someone who's educated enough
• 49:19to know about this technology.
• 49:21It's gonna say, will you
• 49:22please try
• 49:23the artificial womb technology?
• 49:26I'm not saying you should
• 49:27or you shouldn't. What I'm
• 49:28saying is you don't wait
• 49:29until the first time someone
• 49:30asks that in a clinical
• 49:32setting
• 49:32before asking that to each
• 49:34other.
• 49:35And not just sitting around
• 49:36thinking about it, but coming
• 49:38up with a feasible,
• 49:40fair, ethically defensible
• 49:42answer
• 49:43before the first human being
• 49:45goes in.
• 49:47Alright. So now there's wider
• 49:48societal effects. So somebody on
• 49:50Wired last year, oh, a
• 49:51year and a half ago,
• 49:52published this thing saying, listen,
• 49:54man. Ectogenesis,
• 49:55which is gestation outside of
• 49:56the artificial womb, this is
• 49:58gonna be real soon, and
• 49:59this could cause potential harm.
• 50:01This could really screw up
• 50:03reproductive rights.
• 50:05Because now what's gonna happen
• 50:06is, well, some philosophers say
• 50:08that that that, women in
• 50:10reproduction are gonna be replaced.
• 50:11And, Anna, let's not get
• 50:12into that. I mean, this
• 50:13is say, alright. That's a
• 50:14little out there. But this
• 50:15is important because they talk
• 50:16about ectogenesis, which means we
• 50:18can start from a single
• 50:19cell and develop a human
• 50:21being
• 50:22all the way to blive
• 50:23it on the outside,
• 50:24okay,
• 50:26to a full term baby.
• 50:28But here's the deal.
• 50:30Some abortion laws are indeed
• 50:32based on viability, and this
• 50:33could influence
• 50:34reproductive rights.
• 50:36But remember the science. Ectogenesis
• 50:39is a distraction,
• 50:40which is to say that
• 50:41that technology that takes us
• 50:42from single cell to a
• 50:44living full term baby, that
• 50:46technology is not even on
• 50:48the next horizon after the
• 50:49next horizon.
• 50:50So I don't think our
• 50:51opinions about that should influence
• 50:53whether we can use this
• 50:54technology now to try and
• 50:56save some babies who we
• 50:56might potentially save. So when
• 50:58folks say, Ectogenesis, oh my
• 51:00god. But you might remember,
• 51:01those of you who are
• 51:02really old, which is to
• 51:03say my
• 51:05age, might remember, and it's
• 51:07gonna sound funny to the
• 51:08students. But her name was
• 51:09Louise Brown.
• 51:11And when we were young,
• 51:12but not babies,
• 51:13she was the first test
• 51:15tube baby they called. It
• 51:16was the first in vitro
• 51:17fertilization case. It was in
• 51:18England. Right? Doctor Steptoe.
• 51:20And,
• 51:21and the the the country
• 51:22went wild. This is nuts.
• 51:24This is crazy. Well, now
• 51:26that's just what we do.
• 51:27And most of us think
• 51:28that's a nice thing to
• 51:29make available to people who
• 51:30are trying to have a
• 51:30baby and having difficulty.
• 51:32Alright? So Ectogenesis,
• 51:34though, that's a distraction. We've
• 51:35gotta figure out what to
• 51:36do about this technology
• 51:37here and now. But by
• 51:38the way, it's not just
• 51:39some writers on Wired. This
• 51:41is Vardit Rovitsky, who some
• 51:42of you might remember was
• 51:43our invited speaker.
• 51:45I think she was our
• 51:46Duffy lecturer,
• 51:48which is our
• 51:49highest honor.
• 51:51She is the the president
• 51:52of the Hastings Center, the
• 51:53country's leading bioethics think tank.
• 51:55She's also on the faculty
• 51:56of Harvard. There's another Harvard
• 51:58faculty member down there,
• 52:00doctor King. And they're telling
• 52:02us in a political climate
• 52:03where reproductive rights are being
• 52:05curtailed in the name of
• 52:06protecting fetuses,
• 52:08Safe and effective artificial wombs
• 52:10could be used to argue
• 52:11that the fetus is not
• 52:13only has a right to
• 52:14live, but also has the
• 52:15right to any and all
• 52:17medical care available. Now follow
• 52:18what they're saying to us.
• 52:19This is in Scientific American
• 52:21last year. They're saying that
• 52:22such an argument could promote
• 52:24legislation
• 52:25that requires dangerous surgery
• 52:28despite
• 52:29a patient's
• 52:30objection.
• 52:31So what they're suggesting is
• 52:32now a woman's in labor
• 52:33at twenty two weeks.
• 52:36And now, you know, that
• 52:37we know we could save
• 52:38this kid if we've got
• 52:40this technology. Let's say we're
• 52:41at a point where the
• 52:42technology is is perfected or
• 52:44is really good.
• 52:45We could save this kid.
• 52:47So So if she doesn't
• 52:47want it, well, then we're
• 52:48gonna tell, well, you have
• 52:49to have a c section
• 52:50so we can use the
• 52:52bio bag
• 52:53even if she doesn't want
• 52:54the seizures. That's the fear.
• 52:56And so these authors are
• 52:57saying and these let's say
• 52:58these aren't these are serious
• 53:00academics. They're saying, therefore, hold
• 53:03on. Let's not move forward
• 53:04with this technology because this
• 53:05can have a serious implication
• 53:07for reproductive rights, serious societal
• 53:09implications.
• 53:10So that's something that we
• 53:12should consider.
• 53:13But I got something else
• 53:15to consider. Then I'm done.
• 53:16This isn't gonna go on,
• 53:17we're gonna we're gonna end
• 53:18in five minutes, and then
• 53:19I wanna hear from you.
• 53:20But there's something else to
• 53:21consider.
• 53:22Alright. Remember doctor Kotish's balance.
• 53:25Individual beneficence must take precedence
• 53:28over collective notions of beneficence.
• 53:30We gotta be careful not
• 53:31to sacrifice one kid for
• 53:33the benefit of future kids,
• 53:35basically.
• 53:36And by the way, I
• 53:37put these two pictures here
• 53:38because sometimes we're thinking and
• 53:39looking at this kid. This
• 53:40kid becomes the kid on
• 53:42the right. Kid on the
• 53:43left becomes the kid on
• 53:44the right, becomes you or
• 53:45me. Right? That that's our
• 53:47goal. That's who we're working
• 53:48for is that kid
• 53:50who obviously aspires to be
• 53:51a Yale medical student, and
• 53:53there is no higher honor.
• 53:55Okay? So we're balancing the
• 53:57best interest of the child
• 53:58subject against the science of
• 54:00others. Ah, but here's an
• 54:01interesting question. Right?
• 54:03May we also say
• 54:06that individual beneficence must not
• 54:08take precedence
• 54:09over collective notions of beneficence.
• 54:11That's doctor Kotish, but I
• 54:12say, or collective notions of
• 54:14harm.
• 54:15Is there a threshold of
• 54:17anticipation of anticipated harm
• 54:19to the society
• 54:21to reproductive rights, for example,
• 54:23that would trump individual beneficence.
• 54:25Because what we may potentially
• 54:27be saying is, yes. I
• 54:28mean, not today, but if
• 54:29this technology, we move forward
• 54:31with it. Yes. We could
• 54:32save your child in the
• 54:33upper right, but we're not
• 54:34gonna do it because this
• 54:35could have harm to society
• 54:37or this could harm,
• 54:39people in the future.
• 54:41That's a really interesting question.
• 54:42Okay? Individual deficits must take
• 54:44precedence, but also
• 54:46over collective notions of harm.
• 54:48Can we say that? It's
• 54:49a fascinating question. Of course,
• 54:50is it a threshold argument?
• 54:52Might this depend then on
• 54:54the likelihood
• 54:55and magnitude of the anticipated
• 54:57harm? So if there's a
• 54:58tiny bit of harm to
• 54:59a very small number of
• 55:00people deep in the future,
• 55:02we would say, well, we
• 55:03gotta save this baby if
• 55:04we can. If there's a
• 55:06colossal harm to a lot
• 55:07of people next week, we
• 55:08might be less inclined to
• 55:10go forward.
• 55:11The likelihood and magnitude of
• 55:13the anticipated harm and the
• 55:14likelihood
• 55:15and magnitude
• 55:16of the anticipated benefit. So,
• 55:18for example, if artificial womb
• 55:20can save fifty percent of
• 55:21people,
• 55:22okay, and current technology can
• 55:24save forty five percent
• 55:26with the same disability profile,
• 55:28for example,
• 55:29that's not a great anticipated
• 55:31benefit. So if there's a
• 55:32huge societal harm, maybe we
• 55:34shouldn't go forward. But somebody,
• 55:36that means you guys, need
• 55:37to be thinking about it.
• 55:38And now we're do excuse
• 55:39me. Now we're doing some
• 55:40ethics.
• 55:41But remember, we're doing this
• 55:42because someone's trying to save
• 55:44some kids. That's why we're
• 55:45doing all this stuff. So
• 55:46someone's gotta put their nickel
• 55:48down, and my friend Stephanie
• 55:49Kukura did. Okay? So how
• 55:51bad does the risk have
• 55:52to be? How likely does
• 55:54it have to be that
• 55:54a baby's gonna die before
• 55:56we're willing to say, sure.
• 55:57Put them in the bag.
• 55:58She says, alright. I'll I'll
• 56:00play. She says less than
• 56:01twenty percent predicted survival. Now
• 56:03if you if we follow
• 56:04her recommendation,
• 56:06if you remember, it was
• 56:07only the tiniest
• 56:09male,
• 56:10tiny male,
• 56:13twenty two weeks,
• 56:15who didn't get steroids who
• 56:16are gonna be less than
• 56:17twenty percent. It's pretty much
• 56:18everybody that we keep track
• 56:19of has got a better
• 56:20than twenty percent chance to
• 56:21survive. Just a really scrawny
• 56:22boys who don't get steroids.
• 56:24Okay? Then she's saying and,
• 56:26of course, the people who
• 56:27want who are championing this
• 56:28technology, who've spent their lives
• 56:29developing it, they don't wanna
• 56:31do that. They wanna put
• 56:32lots of kids on it
• 56:33to find out if it
• 56:34works or not.
• 56:35Okay? Now what she's saying
• 56:37is that once we've shown
• 56:37that it works,
• 56:39then basically move up and
• 56:40we say the threshold is
• 56:41there's a twenty to fifty
• 56:42percent chance of survival, we
• 56:43should use it. And then
• 56:44we talk about long term
• 56:46neurodevelopment. But she wants to
• 56:47start with twenty percent. You
• 56:49guys are gonna decide, is
• 56:50that right? How low does
• 56:52the likelihood of survival have
• 56:53to be for us to
• 56:54be willing to put this
• 56:55kid
• 56:56on the artificial womb?
• 56:59Alright. So we need concrete
• 57:01recommendations.
• 57:01This is wrapping up three
• 57:03things
• 57:04for us to think about.
• 57:05Questions that have to be
• 57:06answered, in my opinion, before
• 57:07the human trials.
• 57:08What's the appropriate survival prognosis
• 57:10threshold with current technology
• 57:13for early artificial womb trials?
• 57:15And what likelihood and severity
• 57:16of anticipates
• 57:18anticipated disability
• 57:19do we need
• 57:21to take that risk of
• 57:22the artificial womb?
• 57:23And lastly, what likelihood and
• 57:25severity of harm to others,
• 57:27for example, reproductive rights, if
• 57:29any, should delay human trials?
• 57:31These are easy questions. You
• 57:33guys have got a half
• 57:33an hour, so let me
• 57:35know because
• 57:36I'm done, and I wanna
• 57:38hear from you. And by
• 57:39the way, this is not
• 57:40just some kind of exercise
• 57:41because, by the way, the
• 57:42debate is still going on
• 57:43on a national level.
• 57:45And last I heard, which
• 57:47was last week, there was
• 57:48no answer from the FDA.
• 57:50And I think they've been
• 57:50busy for the weeks and
• 57:51so. So or maybe not.
• 57:53Maybe they don't have much
• 57:54to do. I don't know.
• 57:55But the point is this
• 57:56is an ongoing question that
• 57:57that we as an academic
• 57:59community and we as a
• 58:01society
• 58:02need to face before we
• 58:04start putting babies
• 58:05on the artificial womb. Now
• 58:07I wanna hear from you.
• 58:08Sarah, you're in charge.
• 58:10Thank you very much.
• 58:15Alright. Thank you. Before I
• 58:15go over there, though Yeah.
• 58:16Let me grab it here.
• 58:17Some high technology. No. I'm
• 58:19gonna do this.
• 58:20See?
• 58:21You know, what? Going the
• 58:22wrong way.
• 58:23This only take about twenty
• 58:25minutes, so sit tight. Alright.
• 58:26Well, I'm gonna pull up
• 58:27that chair. You go where
• 58:28you're gonna time. That's where
• 58:29I'm gonna sit.
• 58:32On the table. And I'm
• 58:33Otherwise, they can't see me.
• 58:34I'm too short. Okay. I'll
• 58:35pull it around.
• 58:39Bear with me here.
• 58:43Alright.
• 58:44Any questions
• 58:45to start us off in
• 58:46the audience?
• 58:47Certainly, we
• 58:49Got questions there?
• 58:50Okay. So you can you
• 58:51can share with the with
• 58:53the Great. She'll read the
• 58:54ones that she wants to
• 58:56leave. And I wanna hear
• 58:57you. Which is that one?
• 58:58Alright. Well, we'll start from
• 58:59the Zoom. Let's start with
• 59:00the audience, and then,
• 59:01I I didn't came out
• 59:02in the.
• 59:04I I didn't think we
• 59:05had any takers, but if
• 59:06there is a taker alright.
• 59:09Doctor Hughes.
• 59:12Thank you,
• 59:13sir.
• 59:15Would you,
• 59:17mind considering
• 59:19or thinking with us about
• 59:22cost?
• 59:23And
• 59:24does that figure into the
• 59:25harm calculation?
• 59:27And if so, how? And
• 59:29it's not any different from
• 59:30lots of other technologies that
• 59:32that are under development
• 59:34when we have all these
• 59:35considerations
• 59:36about
• 59:37lack of equity and
• 59:40and issues. Thank you. Thank
• 59:41you, sir. So Yeah. What
• 59:43do you think? Great. Am
• 59:45I on? What do you
• 59:45think? Hear him. Is that
• 59:46working? Yep. So it's a
• 59:47great question about cost. Right?
• 59:49A cost is not meaningless
• 59:51here,
• 59:53and it's very hard to
• 59:54figure out. So this is
• 59:56gonna be expensive
• 59:58just as ECMO is expensive.
• 01:00:00Here's the thing. We play
• 01:00:02in neonatology
• 01:00:03with very high stakes, which
• 01:00:05is to say if we
• 01:00:06do a good job, we
• 01:00:06just bought somebody eighty years
• 01:00:08or ninety years.
• 01:00:10Now
• 01:00:11if we prevent eighty or
• 01:00:13ninety years of severe disability
• 01:00:15with this technology,
• 01:00:16that's a colossal savings. So,
• 01:00:18yes, there were high costs.
• 01:00:20In the end, is this
• 01:00:21gonna cost money or save
• 01:00:23money? I don't know the
• 01:00:24answer to that. It's a
• 01:00:25consideration.
• 01:00:26But
• 01:00:27the this gets to the
• 01:00:29point, and, Jack, I'm glad
• 01:00:30you raised it. Because as
• 01:00:31we're having this
• 01:00:33national dialogue, I hope, about
• 01:00:35this, that's gotta be one
• 01:00:36of the things we talk
• 01:00:37about. Because there are people
• 01:00:38way smarter than me, like
• 01:00:40you, who can actually sit
• 01:00:41down and let's run some
• 01:00:43scenarios.
• 01:00:43Let's run some numbers and
• 01:00:45do our best to figure
• 01:00:46out what this is gonna
• 01:00:47do. He talked about harm
• 01:00:48to others. So, of course,
• 01:00:49what he's talking about is,
• 01:00:50right, is if we can
• 01:00:51save this baby for the
• 01:00:52same money that we could
• 01:00:53have used,
• 01:00:54to provide free lunch to
• 01:00:55ten thousand children,
• 01:00:57then maybe that wasn't the
• 01:00:58right way to spend that
• 01:00:59money
• 01:01:00if that money would have
• 01:01:01been spent providing free lunch
• 01:01:02to ten thousand children. So
• 01:01:04cost is important. I'm right
• 01:01:05there with you, Jack, but
• 01:01:06I would not assume
• 01:01:07that that's a deal breaker,
• 01:01:09one. The second thing is,
• 01:01:12again, speaking as a neonatologist,
• 01:01:13so you know my bias
• 01:01:15and what I wanna what
• 01:01:16I spend my life doing
• 01:01:17here, is that what we
• 01:01:18spend on these babies
• 01:01:20is a rounding error compared
• 01:01:21to what we spend on
• 01:01:22people in their nineties.
• 01:01:24So,
• 01:01:25again, speaking as an neonatologist,
• 01:01:26if you're coming for somebody
• 01:01:28because of cost,
• 01:01:29don't come for the babies
• 01:01:30first.
• 01:01:31Okay?
• 01:01:32That sounds great and heroic
• 01:01:34and dramatic.
• 01:01:35Fact is he's got an
• 01:01:35excellent point that that there
• 01:01:38is no
• 01:01:39we don't have unlimited funds,
• 01:01:40and we have to use
• 01:01:41the money wisely. And when
• 01:01:43someone's gotta think about how
• 01:01:44this might affect our our
• 01:01:46financial situation. Yes. Yeah. I
• 01:01:48I just wanted to say
• 01:01:49that I'm I'm glad we
• 01:01:50went to the moon, and,
• 01:01:52I think we ought to
• 01:01:53keep trying.
• 01:01:57Other questions from the audience.
• 01:01:58Yes.
• 01:02:04Hi. You had a slide
• 01:02:06earlier connecting
• 01:02:07this Hold that. Hold that.
• 01:02:09It's close to me. Hi.
• 01:02:10It's not you. It's me.
• 01:02:11I don't hear what go
• 01:02:11ahead. You had a slide
• 01:02:12earlier connecting this artificial womb
• 01:02:15technology,
• 01:02:16to abortion somehow. Could you
• 01:02:18clarify the point you were
• 01:02:20making on this slide? Sure.
• 01:02:22So the the the point
• 01:02:23was that that that some
• 01:02:26have postulated,
• 01:02:28including,
• 01:02:29doctors Ravitzky and King and
• 01:02:31Scientific American, is that this
• 01:02:32could influence reproductive rights because
• 01:02:35a woman who, for example,
• 01:02:36says, I want to terminate
• 01:02:38because I don't wanna be
• 01:02:39pregnant anymore, then we as
• 01:02:40a society could say, okay.
• 01:02:42You don't wanna be pregnant.
• 01:02:43Then you have a c
• 01:02:44section, and we put the
• 01:02:45baby in the artificial womb.
• 01:02:47And so you had to
• 01:02:47have a c section even
• 01:02:48though you didn't want one.
• 01:02:49So in that way, among
• 01:02:51other ways, it could potentially
• 01:02:53limited reproductive rights. Now you
• 01:02:54may say, that's quite a
• 01:02:56stretch. You gotta understand that's
• 01:02:57we're bioethicists. We get paid
• 01:02:58to do these stretches. You
• 01:02:59know? And some people are
• 01:03:00saying, nope. Not a stretch.
• 01:03:02I mean, so all depends
• 01:03:03on who you are and
• 01:03:04how you view it, but
• 01:03:05that's the point they were
• 01:03:06making.
• 01:03:07Thank you. It's a good
• 01:03:08question. Can I ask a
• 01:03:09follow-up on that?
• 01:03:10Which is,
• 01:03:11in your opinion, how much
• 01:03:13of a stretch is that
• 01:03:14versus how how concerning of
• 01:03:16a consideration is that?
• 01:03:22Not that my opinion is
• 01:03:24any more informed than anyone
• 01:03:25else in the room.
• 01:03:26But since you asked, fair
• 01:03:28enough, you hold my feet
• 01:03:29to the fire.
• 01:03:30If you asked me that
• 01:03:31question six months ago,
• 01:03:33I would say to you
• 01:03:34it's not a risk or
• 01:03:35it's a minimal risk. I
• 01:03:36would say to you now
• 01:03:38that I think
• 01:03:39in New Haven, Connecticut, it
• 01:03:41is still an extremely low
• 01:03:42risk, but not a zero
• 01:03:44risk. I would say that
• 01:03:46in many other states, there
• 01:03:47may be a somewhat higher
• 01:03:49risk, particularly
• 01:03:50when it gets back to
• 01:03:51moral status because people are
• 01:03:53arguing over the fetus who
• 01:03:54had the same moral status
• 01:03:55as a baby. So it's
• 01:03:56less of a stretch for
• 01:03:57them ethically
• 01:03:58to say, well, we're gonna
• 01:04:00have this one person do
• 01:04:01this in order to save
• 01:04:02this other person's life if
• 01:04:03they have equal moral status.
• 01:04:05Now mind you, even that
• 01:04:06for most bioethicists
• 01:04:07is a bridge too far
• 01:04:09because we say, well, you
• 01:04:10don't force people to have
• 01:04:11to donate their bone marrow
• 01:04:12to save their brother.
• 01:04:14Why would you force a
• 01:04:15woman to have a c
• 01:04:15section to save her baby?
• 01:04:17But as you know, as
• 01:04:19everybody in the room knows,
• 01:04:19this is heated stuff. This
• 01:04:21is complicated stuff. So I
• 01:04:23don't think that they are
• 01:04:24crazy to posit it as
• 01:04:26a possibility.
• 01:04:27I don't think it's a
• 01:04:28high possibility today, but these
• 01:04:30are uncertain times.
• 01:04:35Thanks a lot for your
• 01:04:36talk. Thank you.
• 01:04:39Question, I you know, I
• 01:04:39think when you're when you're
• 01:04:40considering the utility of artificial
• 01:04:42wound technology, the other side
• 01:04:43of the coin is,
• 01:04:45you know, how bad is
• 01:04:46the ventilator induced lung injury.
• 01:04:48And just wondering from a
• 01:04:50neonatology
• 01:04:50perspective if,
• 01:04:54if
• 01:04:55you think that with improvements
• 01:04:56in ventilator technology, the rates
• 01:04:58of BPD have gotten better
• 01:05:00and or if you anticipate
• 01:05:01that happening or changing at
• 01:05:02all sort of in the
• 01:05:03foreseeable future?
• 01:05:05Well, I think that's a
• 01:05:06great question. And the answer
• 01:05:07is we've certainly gotten better
• 01:05:08and smarter about how we
• 01:05:09use ventilators, how we use
• 01:05:11oxygen.
• 01:05:12So, yeah, there's things we
• 01:05:14can do with, high frequency
• 01:05:16ventilation, potentially with jet ventilation.
• 01:05:17There's things we can do
• 01:05:18to decrease the likelihood
• 01:05:20of severe damage to the
• 01:05:21lungs.
• 01:05:23And that has to be
• 01:05:24figured in. Because, for example,
• 01:05:25if someone is just using
• 01:05:26a conventional ventilator and they
• 01:05:28say, there's just too high
• 01:05:29a risk of damaging these
• 01:05:30lungs. So, you know, at
• 01:05:32this gestation age, so we're
• 01:05:33gonna go with the artificial
• 01:05:34womb.
• 01:05:36Someone might say, well, hang
• 01:05:37on. Why don't you try
• 01:05:38a high frequency or now,
• 01:05:39Steve, you again, and Sam?
• 01:05:40I mean, with the jet,
• 01:05:41with these tiny babies, are
• 01:05:42you having some success with
• 01:05:43the jet
• 01:05:45in terms of preventing BPD
• 01:05:46too soon to really answer
• 01:05:47that question?
• 01:05:48High frequency compared to Say
• 01:05:50again?
• 01:05:51High frequency compared to conventional
• 01:05:53ventil
• 01:05:54High frequency compared to conventional
• 01:05:55ventilation hasn't really shown a
• 01:05:57reduction in BPD. Actually, in
• 01:05:58the last ten years, BPD
• 01:05:59has not really budged in
• 01:06:00terms of the frequency of
• 01:06:01the outcome. More babies are
• 01:06:03surviving, some more surviving to
• 01:06:04the the age at which
• 01:06:05they develop BPD. So I'd
• 01:06:07say if if anything, BPD
• 01:06:08is static or or climbing.
• 01:06:10So you were asking, why
• 01:06:11can't I bring a national
• 01:06:13expert on BPD to these
• 01:06:14talks? The answer is, hey,
• 01:06:15man. I did.
• 01:06:16Okay. And I did. That's
• 01:06:18doctor Sam Gentle. He knows
• 01:06:19where of he speaks. Now
• 01:06:21that doesn't mean we can't
• 01:06:22get better at it. And
• 01:06:24so maybe things we could
• 01:06:25do. And it's that gets
• 01:06:26back to remember that second,
• 01:06:29point of the common rule,
• 01:06:30which was the thing we're
• 01:06:32trying to use
• 01:06:33has to be better than
• 01:06:35the best available alternatives.
• 01:06:37So it may be there's
• 01:06:38other ways we could ventilate
• 01:06:39the kid. But, frankly,
• 01:06:41BPD, as difficult as it
• 01:06:42is,
• 01:06:43it I don't think it
• 01:06:44scares people as much as
• 01:06:47the severe,
• 01:06:48neurologic,
• 01:06:49neurodevelopmental
• 01:06:50impairment
• 01:06:51that so many of these
• 01:06:52kids have left with. And,
• 01:06:52of course, the the the
• 01:06:54mortality as well. But it's
• 01:06:55BPD remains terribly important. Some
• 01:06:58people spend their lives trying
• 01:06:59to work it out.
• 01:07:00It's terribly important. There may
• 01:07:01be ways to make it
• 01:07:02better. So that's a good
• 01:07:03point. That's a fair point.
• 01:07:06Just not just not as
• 01:07:07Sam pointed out that we
• 01:07:08don't have that trick, in
• 01:07:10our back pocket right yet.
• 01:07:11Hey, doctor Mercurio. Nice to
• 01:07:13see you. Happy twenty twenty
• 01:07:14five.
• 01:07:16It's not really a question,
• 01:07:17more of a more of
• 01:07:18a comment. So going off
• 01:07:19the concern about,
• 01:07:22abortion laws and,
• 01:07:24the current political status of
• 01:07:25that and the two Harvard
• 01:07:27physicians saying this might not
• 01:07:28be the right time. I
• 01:07:29think what I would say
• 01:07:30to that is abortion has
• 01:07:31been a contentious issue in
• 01:07:33our nation for for many
• 01:07:35maybe going on centuries, and
• 01:07:36that's not an argument that's
• 01:07:37gonna go away. So if
• 01:07:38you're waiting for political consensus
• 01:07:40to develop on fetal personhood
• 01:07:42or
• 01:07:43when consciousness
• 01:07:44has developed, that's not gonna
• 01:07:45happen. And so if you
• 01:07:47push,
• 01:07:49if you push if you
• 01:07:50use that as a reasoning
• 01:07:51to not,
• 01:07:53begin testing this, it's never
• 01:07:54gonna happen. You know? You're
• 01:07:55not gonna get fifty states
• 01:07:57to ever agree
• 01:07:58on on anything.
• 01:08:00Okay. Thank you.
• 01:08:06Oh, there we go.
• 01:08:12Hi. I'm not sure if
• 01:08:12you have an answer to
• 01:08:13this question, but I was
• 01:08:14wondering,
• 01:08:15just thinking about the FDA.
• 01:08:17Are there any other conversations
• 01:08:18happening in different countries of
• 01:08:20different regulatory agencies about this
• 01:08:22technology?
• 01:08:23Especially especially I'm thinking about
• 01:08:24other
• 01:08:25countries don't necessarily have this,
• 01:08:27like, reproductive rights really playing
• 01:08:29into that conversation, and it's
• 01:08:30a lot more secure, and
• 01:08:31that's not really a valid
• 01:08:33threat. So I'm just wondering
• 01:08:34That's a great question. I
• 01:08:35think some of this technology
• 01:08:36is actually being trialed, in
• 01:08:38Japan.
• 01:08:40And I'm not personally familiar
• 01:08:42with exactly what that conversation
• 01:08:43is, but I wanna make
• 01:08:44the point to to the
• 01:08:46question the gentleman in the
• 01:08:47last in the back asked,
• 01:08:47which you which is relevant
• 01:08:48to yours as well, was,
• 01:08:50I've talked about this technology,
• 01:08:52the extend technology, which I
• 01:08:54think is fascinating.
• 01:08:55But it requires us to
• 01:08:56decide before birth. We're gonna
• 01:08:59do a c section take
• 01:09:00to get output directly into
• 01:09:01the bio bag.
• 01:09:02Other technologies, other artificial placenta
• 01:09:05technologies are we could take
• 01:09:07the child out, try for
• 01:09:08a bit on the ventilator,
• 01:09:10see how we're doing, and
• 01:09:11if we fail, hook the
• 01:09:13umbilical vessels up to a
• 01:09:14membrane oxygenator
• 01:09:16and basically do something more
• 01:09:17akin to ECMO, which is
• 01:09:19to say we're not inside
• 01:09:20that fluid environment.
• 01:09:21And some of the advantages
• 01:09:23of that fluid environment, I
• 01:09:24think you understand.
• 01:09:25So the conversation
• 01:09:27I mean, that may
• 01:09:29be that's another way to
• 01:09:30do this, if you will,
• 01:09:31is is is after the
• 01:09:33kid comes out, figure out
• 01:09:34if we're like I do
• 01:09:35it as a rescue therapy
• 01:09:36instead of as a preventive
• 01:09:37therapy. But in terms of
• 01:09:38the conversation in other countries,
• 01:09:40it's a great question. And,
• 01:09:41honestly, I don't know the
• 01:09:42answer to it.
• 01:09:45Is she here? And then
• 01:09:46over there, Steve.
• 01:09:48You you mentioned that the
• 01:09:49intention of the technology is
• 01:09:50not to push the limit
• 01:09:51of of vi
• 01:09:52you mentioned that the technology,
• 01:09:54like, the intent behind is
• 01:09:55not to push the limit
• 01:09:56of viability to, like, push
• 01:09:58it down to twenty one
• 01:09:59weeks. But But just I'm
• 01:10:00trying to think about this
• 01:10:01pragmatically in your first question
• 01:10:03about the percent threshold of
• 01:10:04survival or survival without morbidity.
• 01:10:06It's it would seem kind
• 01:10:08of prudent to use twenty
• 01:10:09one weeks because of the
• 01:10:10the variability ins of survival
• 01:10:12in twenty two weeks.
• 01:10:14If you're, you know, quoting
• 01:10:15such a a vast range
• 01:10:16of thirty to eighty percent
• 01:10:17survival,
• 01:10:18why not just do it
• 01:10:19in the the the pariviable
• 01:10:21or the the likely nonviable,
• 01:10:23fetus? I'm just I'm I'm
• 01:10:25putting myself in a room
• 01:10:26with a a bunch of
• 01:10:26neos trying to design a
• 01:10:28trial and not being able
• 01:10:29to to define that consensus
• 01:10:31because I was gonna argue,
• 01:10:32well, we can save twenty
• 01:10:34two weekers irrespective of the
• 01:10:36interventions.
• 01:10:37Whereas, you know, other centers
• 01:10:38that don't have such survival
• 01:10:40rates will will argue if
• 01:10:41they wanna,
• 01:10:42enroll at their center and
• 01:10:43they would have equipoise. So
• 01:10:45I'm just kinda curious as
• 01:10:46to why not twenty one.
• 01:10:47It's a great question, and
• 01:10:48scientifically,
• 01:10:49it makes sense. There's at
• 01:10:51least three reasons why we
• 01:10:52wouldn't do that. The the
• 01:10:54first that's easiest is that
• 01:10:56they tell us,
• 01:10:57and I believe them that
• 01:10:58that that they the technology
• 01:10:59simply can't work on that
• 01:11:00on babies that small. But,
• 01:11:02of course, you know that
• 01:11:03there's big twenty one weekers
• 01:11:05and small twenty two weekers.
• 01:11:06But one is it's just
• 01:11:07not feasible. So that's easy.
• 01:11:08They answer the question. Then,
• 01:11:10of course, we have to
• 01:11:11say, well, what if it
• 01:11:12were feasible? What if we
• 01:11:13had a really big twenty
• 01:11:14one weaker?
• 01:11:15The other reasons are that
• 01:11:16when you talk about pushing
• 01:11:17that line back below twenty
• 01:11:19two weeks, you see neonatologists.
• 01:11:22You can actually watch it.
• 01:11:22You can hear it if
• 01:11:23you're on the street. Neonatologists'
• 01:11:24heads exploding
• 01:11:26because, because caring for these
• 01:11:27kids at twenty two weeks
• 01:11:29is and I've seen some
• 01:11:30NICU nurses' heads that might
• 01:11:31explode too,
• 01:11:32that it's so difficult.
• 01:11:34And what we feel that
• 01:11:35we put these kids through
• 01:11:36is such a difficult time
• 01:11:38that to move that line
• 01:11:39to many people seems just
• 01:11:40the wrong thing to do.
• 01:11:42And so they they wanted
• 01:11:44to say that, I think,
• 01:11:45in part because
• 01:11:46if we focused on that,
• 01:11:48we, the profession,
• 01:11:49we, the scientific community, would
• 01:11:51never get behind this. So
• 01:11:53why is it there saying,
• 01:11:54no. This isn't about moving
• 01:11:55the threshold. This is about
• 01:11:56doing a better job for
• 01:11:57the kids we're already
• 01:11:59treating.
• 01:12:00Now from a scientific point
• 01:12:01of view, what you're saying
• 01:12:02makes sense. The third reason
• 01:12:04not to, though, is the
• 01:12:05same concerns that Vardit Ravitsky
• 01:12:07and others raised. As you
• 01:12:08move that further back, the
• 01:12:09fears about how that's gonna
• 01:12:10influence reproductive rights are only
• 01:12:12gonna become worse. So for
• 01:12:13all those reasons, they're not
• 01:12:14doing it. But they'll just
• 01:12:15start by saying
• 01:12:17that that we don't have
• 01:12:18the technology. We don't have
• 01:12:19the catheters aren't small enough
• 01:12:20or whatever. So that's why
• 01:12:21we don't do it. But
• 01:12:22it's a it's not a
• 01:12:23bad question. It's not a
• 01:12:25bad question. But I think
• 01:12:26it's gonna scare a lot
• 01:12:28of people. And by the
• 01:12:28way, again, for some perspective
• 01:12:29or someone who's been at
• 01:12:30this for a while, and
• 01:12:31this was raised recently. I
• 01:12:32was talking to a colleague
• 01:12:33of my generation at another
• 01:12:35place who was saying, yep.
• 01:12:36I was it was last
• 01:12:37week. I was at, Nationwide
• 01:12:39in in Ohio. They said,
• 01:12:40yeah. I remember when we
• 01:12:41went from twenty six to
• 01:12:42twenty five weeks, and everybody's
• 01:12:44head exploded. And then pretty
• 01:12:45soon, that just became what
• 01:12:46we did. Then we went
• 01:12:47from twenty five to twenty
• 01:12:48four, and everybody went nuts.
• 01:12:49You're out of your mind.
• 01:12:50Don't do that. And now
• 01:12:51as you saw, we can
• 01:12:52save almost all those kids.
• 01:12:53And most of them have
• 01:12:54a pretty good outcome. And
• 01:12:55then we went from twenty
• 01:12:56four eight, etcetera. So every
• 01:12:58time the line moves, people
• 01:12:59say, that's crazy. Don't do
• 01:13:01it. And we and we
• 01:13:02know now we can't possibly
• 01:13:04go any lower, and then
• 01:13:05we do. So our fear
• 01:13:07of moving the line, I
• 01:13:09don't think by itself is
• 01:13:10a sound ethical argument.
• 01:13:13But I'm scared too. I
• 01:13:14mean, if you ask me
• 01:13:15right now, what do you
• 01:13:15say we start trying?
• 01:13:17Meantime, next week, I'm going
• 01:13:18three weeks. I'm going Iowa
• 01:13:20where they've already done that,
• 01:13:21where they offer it at
• 01:13:22twenty one weeks. I'm curious
• 01:13:23to find out exactly how
• 01:13:24they're doing and what's going
• 01:13:25on.
• 01:13:27Steve.
• 01:13:29Hey, Mark. Oh, Steve. I
• 01:13:31have
• 01:13:32a a question about the
• 01:13:33the I guess it's the
• 01:13:34middle of the three standards
• 01:13:35that that says we should
• 01:13:37only
• 01:13:40be offering this if it's
• 01:13:41gonna be,
• 01:13:44if the
• 01:13:45If it's better than what's
• 01:13:46already available, Fred. Better than
• 01:13:47what's already available.
• 01:13:51This is a question that
• 01:13:51comes up with, you know,
• 01:13:52xenotransplant.
• 01:13:53It comes up
• 01:13:55with CAR T cancer therapy.
• 01:13:57Right? Anytime anytime there's a
• 01:13:58new therapy, we wanna test
• 01:14:00it by giving it to
• 01:14:01the people who will not
• 01:14:02benefit from the existing therapies
• 01:14:04for the most part. So
• 01:14:05first, that's gonna give you
• 01:14:07it's gonna make your new
• 01:14:08thing look really terrible. Right?
• 01:14:10Because we're trying it on
• 01:14:11the people who are too
• 01:14:13high risk for our current
• 01:14:14system. So it's gonna be
• 01:14:15they're gonna get terrible outcomes.
• 01:14:17You can you can guess.
• 01:14:18Right? For the same reasons
• 01:14:19they get terrible outcomes in
• 01:14:20our existing system,
• 01:14:22they're gonna get terrible outcomes
• 01:14:23in the experimental thing. So
• 01:14:24you're gonna have to do
• 01:14:26some work to very incrementally
• 01:14:28move up who you're testing
• 01:14:29this on based on what
• 01:14:30you learn. So so so
• 01:14:32it it biases the the
• 01:14:33experiment toward toward failure.
• 01:14:35And maybe that's worth it
• 01:14:37because we're supposed to be
• 01:14:38caring more about
• 01:14:40individual beneficence than about systemic
• 01:14:42effect. Okay. But there's another
• 01:14:43thing that it rules out,
• 01:14:45which is
• 01:14:46coming up with a new
• 01:14:47technology that is
• 01:14:49eighty five percent as effective
• 01:14:51as what we have now
• 01:14:53and cost one tenth as
• 01:14:55much, or it can be
• 01:14:56done by a single dock
• 01:14:57in a in a empty
• 01:14:59room
• 01:15:00in,
• 01:15:02Sierra Leone.
• 01:15:04That if if we only
• 01:15:06ever
• 01:15:07wanna test things
• 01:15:09that are clinically better
• 01:15:11than what we have,
• 01:15:13that seems to lead us
• 01:15:15away from testing things that
• 01:15:16might not be as good
• 01:15:17as what we have, but
• 01:15:18they'll be much more accessible
• 01:15:20to many more people.
• 01:15:24That's a good point.
• 01:15:26Remembering,
• 01:15:28I think that's a good
• 01:15:29point when you take,
• 01:15:31the the the broad view.
• 01:15:32Take the societal view, etcetera.
• 01:15:35When we're talking to the
• 01:15:36parents of a given child
• 01:15:38and say, we have something
• 01:15:39here that's almost as good
• 01:15:40as current therapy, but it's
• 01:15:42gonna cost a lot less
• 01:15:43money. It's the rare parent
• 01:15:44who's gonna say go for
• 01:15:45it. Because, frankly, among other
• 01:15:47things first of all, even
• 01:15:48if I was paying for
• 01:15:49it myself, I wouldn't do
• 01:15:50that. But among other things,
• 01:15:52almost no one's actually paying
• 01:15:53for this themselves.
• 01:15:54So to get someone to
• 01:15:56actually consent for that with
• 01:15:57given if you give true
• 01:15:58and permission really, right, in
• 01:16:00pediatrics, to get true and
• 01:16:01informed permission to say, this
• 01:16:02is not gonna be as
• 01:16:03good as what we're doing
• 01:16:04on the other kids, but
• 01:16:05it's gonna cost your insurance
• 01:16:07company or the federal government
• 01:16:08or whoever's paying the bill.
• 01:16:10It's gonna cost them less.
• 01:16:11What I would say probably
• 01:16:13what most people would say
• 01:16:14is, not on my kid.
• 01:16:16So it's gonna be very
• 01:16:17difficult to do. Nevertheless,
• 01:16:19your point stands that in
• 01:16:21the big picture, given the
• 01:16:22realities of limited resources,
• 01:16:25it might be a smart
• 01:16:26thing to do, but it's
• 01:16:27gonna be very hard to
• 01:16:28get informed permission to do
• 01:16:29it. Yeah. They're probably what
• 01:16:30we have to do is,
• 01:16:31test it abroad using money
• 01:16:33from, US state oh, no.
• 01:16:35Never mind.
• 01:16:37Yeah. That's great. And that's
• 01:16:38why we zoom this out
• 01:16:39so we can piss off
• 01:16:40as many people as possible.
• 01:16:41Thanks for that, Steve. That's
• 01:16:42great. That's great.
• 01:16:44Thank you, Steve.
• 01:16:46Yeah. Maybe maybe more of
• 01:16:47a sudden.
• 01:16:48Wait. Wait. Wait. Wait. Wait.
• 01:16:49Wait. You know, questionnaires.
• 01:16:51And then and then you
• 01:16:52go yeah. No problem. Yeah.
• 01:16:53Come on, Brett. Take it
• 01:16:54easy. Will you waste your
• 01:16:54turn?
• 01:16:56I, I I think I
• 01:16:58have a question in here.
• 01:16:59I think,
• 01:17:00you know, it's not unique
• 01:17:01to this situation that all
• 01:17:03the time in pregnancy, we're
• 01:17:04asking pregnant people to balance
• 01:17:07risk to them
• 01:17:08for benefit for the fetus
• 01:17:09or neonate.
• 01:17:11That happens with a variety
• 01:17:12of clinical scenarios. I think
• 01:17:14one of the most challenging
• 01:17:16things in taking care of
• 01:17:17these patients, delivering at the
• 01:17:18threshold of viability,
• 01:17:20when talking about mode of
• 01:17:21delivery specifically, is
• 01:17:23talking about future risk and
• 01:17:25kind of how how do
• 01:17:26you balance in that conversation
• 01:17:27a benefit today
• 01:17:29against risk in the future
• 01:17:30potentially. So if you're doing
• 01:17:31a cesarean at twenty two
• 01:17:33or twenty three weeks, as
• 01:17:34you know, it's gonna be
• 01:17:35a classical histrotomy, always a
• 01:17:37c section,
• 01:17:38risk of accreta, uterine rupture,
• 01:17:40kind of all of these
• 01:17:41things. And I think that,
• 01:17:42you know, when you're when
• 01:17:43you're talking about this new
• 01:17:45technology,
• 01:17:46I think that's, like, one
• 01:17:47of the hardest pieces for
• 01:17:49us doing the counseling about
• 01:17:50mode of delivery. And if
• 01:17:51you're gonna talk about doing
• 01:17:52a hundred percent c sections
• 01:17:54to to sort of
• 01:17:56enable this technology,
• 01:17:58and you're talking about, you
• 01:17:59know, counseling someone who's scared
• 01:18:00and in pain
• 01:18:02is and that's what I
• 01:18:02think is hard for us
• 01:18:04is is kinda how do
• 01:18:05you how do you weigh
• 01:18:06that against the benefit
• 01:18:08today if Take aside the
• 01:18:10considerations of the political climate,
• 01:18:12but, you know, about about
• 01:18:13what we see as this
• 01:18:14person's potential future risk. And
• 01:18:16we offer Caesarean because we
• 01:18:17believe in
• 01:18:18reproductive choice and, you know,
• 01:18:21the the benefit that it
• 01:18:22could hold for today.
• 01:18:23But, you know, against, like,
• 01:18:24this kind of lifetime potentiation
• 01:18:27of of risk for the
• 01:18:28that person.
• 01:18:29That's, I mean, that's,
• 01:18:32that's beautifully said. I won't
• 01:18:33paint on your painting because
• 01:18:34I think you make an
• 01:18:34excellent point, except to say
• 01:18:36something that that you and
• 01:18:37many of the folks in
• 01:18:38the room know very well,
• 01:18:39but maybe not everybody, is
• 01:18:40that at that moment in
• 01:18:41time and, again, for many
• 01:18:42people, parents in the room,
• 01:18:44at that moment in time,
• 01:18:46the no. The the
• 01:18:48parents aren't spending a lot
• 01:18:49of time thinking deep into
• 01:18:51the future. And so it's
• 01:18:52the responsibility of a good
• 01:18:53physician to try and help
• 01:18:55them think about their future
• 01:18:57as well as their present.
• 01:18:57So that classic c section
• 01:19:00could have implications for this,
• 01:19:02you know, eighteen year old's
• 01:19:04future.
• 01:19:05And that's the hard job
• 01:19:07that doctor Cross and others
• 01:19:08have is to try and
• 01:19:08help them weigh that not
• 01:19:10an easy thing to do.
• 01:19:11You made your point beautifully,
• 01:19:12so I won't mess it
• 01:19:13up by talking more. Brad's
• 01:19:15waiting. Yes, sir. Just quickly,
• 01:19:17it may be more of
• 01:19:18a scientific question, but theoretically,
• 01:19:20couldn't this be,
• 01:19:22this method be
• 01:19:24cost be lower in cost
• 01:19:26and lower intent in in
• 01:19:27in
• 01:19:27in,
• 01:19:29intensive nursing care in the
• 01:19:31newborn
• 01:19:33in the newborn period and
• 01:19:34and with less with hopefully
• 01:19:36better neurodevelopmental
• 01:19:38outcome as for the reasons
• 01:19:39you described as the benefits.
• 01:19:42And the answer is that's
• 01:19:43really helpful and really insightful,
• 01:19:44and you're absolutely right. Is
• 01:19:46that what could happen is
• 01:19:47if these kids you know,
• 01:19:48because some of these kids
• 01:19:49who have a very difficult
• 01:19:50time on the ventilator, they
• 01:19:51end up in the hospital
• 01:19:52for a long, long, long
• 01:19:54time. If this gets kids
• 01:19:55out of the hospital weeks
• 01:19:57or months sooner
• 01:19:59than they would have if
• 01:19:59they just had conventional treatment,
• 01:20:01that's gonna have a colossal,
• 01:20:03positive, good effect on overall
• 01:20:05cost. That's possible. You bet
• 01:20:08never mind that if we
• 01:20:09present disability,
• 01:20:10a lifetime of disability, that
• 01:20:12could also have a colossal
• 01:20:14good effect on cost. So
• 01:20:15you're absolutely right, Brad. This
• 01:20:16could be expensive. This could
• 01:20:18also save us a ton
• 01:20:19of money,
• 01:20:20and somebody smarter than me
• 01:20:21needs to do their best
• 01:20:23to model how this might
• 01:20:24go. But the truth is,
• 01:20:24of course, we can't answer
• 01:20:26it because we really don't
• 01:20:27know what's gonna happen until
• 01:20:28we start doing it. And
• 01:20:30then we really can't answer
• 01:20:31it because you wanna know,
• 01:20:32well, how did this go?
• 01:20:33It went really well. The
• 01:20:34kid went home much sooner
• 01:20:35than he would have. Look.
• 01:20:36His lungs are beautiful. Well,
• 01:20:38so how's intellectually? I don't
• 01:20:39know. Come back in seven
• 01:20:40years, and I'll tell you.
• 01:20:41So this isn't gonna be
• 01:20:42an easy thing to sort
• 01:20:43through, but you're absolutely right.
• 01:20:44This could could save a
• 01:20:46lot of money.
• 01:20:49We have a question from
• 01:20:50the Zoom.
• 01:20:51And you sort of you
• 01:20:52already alluded to this, but
• 01:20:54I I my interpretation is
• 01:20:55this person perhaps wants a
• 01:20:56little bit more granularity.
• 01:20:58Is using only the gestational
• 01:21:00age the right criterion for
• 01:21:01selection criteria? It would seem
• 01:21:03that severely growth restricted fetuses
• 01:21:04in a hostile hostile intrauterine
• 01:21:06environment has a different survival
• 01:21:08and morbidity profile to compare
• 01:21:09with. So perhaps you could
• 01:21:10speak a bit more on
• 01:21:11sort of how best to
• 01:21:13select the the first patients
• 01:21:15who might undergo this. That's
• 01:21:16really smart,
• 01:21:18that question. Because, of course,
• 01:21:20we always talk not always.
• 01:21:22We commonly speak in terms
• 01:21:23of gestational age. We just
• 01:21:25talk, well, should we use
• 01:21:26this at twenty two weeks,
• 01:21:27or should we wait for
• 01:21:28twenty three weeks? But as
• 01:21:29I showed you, just the
• 01:21:30they know, the twenty three
• 01:21:31week the twenty two week
• 01:21:33girl has a much better
• 01:21:34chance of survival on conventional
• 01:21:35therapy than the twenty two
• 01:21:37week boy. And there's all
• 01:21:38sorts of different things. And
• 01:21:39that model that model that
• 01:21:41we use, that outcomes estimator
• 01:21:43that we use, all of
• 01:21:44us in the country use,
• 01:21:45puts just a few factors
• 01:21:46in there like size and
• 01:21:48sex and steroids, a few
• 01:21:49other factors. But, of course,
• 01:21:50there's many other things that
• 01:21:52could influence. Right? So, for
• 01:21:53example, what the questioner called
• 01:21:54the hostile intrauterine environment. If
• 01:21:56this kid's in a situation
• 01:21:58where I think, this kid
• 01:21:59really needs to come out,
• 01:22:00this is not gonna go
• 01:22:01well,
• 01:22:02if we continue the pregnancy,
• 01:22:03that's not that's the exceedingly
• 01:22:05difficult job of doctor Cross
• 01:22:06and her colleagues to try
• 01:22:07and figure out when the
• 01:22:08kid's better off inside or
• 01:22:10outside. But that's right. So
• 01:22:11really what it should be
• 01:22:12based on is not gestational
• 01:22:13age. Because as I said,
• 01:22:15and I'm not the first
• 01:22:16one to figure this out,
• 01:22:17gestational age is a poor
• 01:22:19proxy for prognosis.
• 01:22:21What it should be based
• 01:22:22on is prognosis. So that's
• 01:22:24why you see when I
• 01:22:25asked you that last question,
• 01:22:26what likelihood of survival what
• 01:22:28not what gestational age. What
• 01:22:30likelihood of survival has to
• 01:22:32how bad does the likelihood
• 01:22:33of survival have to be
• 01:22:34for us to say, sure.
• 01:22:35Let's try this new technology,
• 01:22:37or let's study it. Let's
• 01:22:38do a randomized trial and
• 01:22:40try it. Now Stephanie Kokura
• 01:22:41and the people who wrote
• 01:22:42that paper said twenty percent.
• 01:22:45Okay. So you say fifteen,
• 01:22:46and he says twenty five.
• 01:22:47We're making up numbers here.
• 01:22:49We've gotta come up with
• 01:22:49some consensus, but there's nothing
• 01:22:51magic about twenty percent. And
• 01:22:52other people would say, no
• 01:22:53way. It should be ten
• 01:22:54percent. Others would say, no.
• 01:22:55Let's do thirty percent because
• 01:22:57or fifty percent because, look,
• 01:22:58we're gonna save their brains.
• 01:23:00Are you sure? Well, no.
• 01:23:01But we really really hope
• 01:23:02we are. You know? That's
• 01:23:04a smart question because it
• 01:23:06should be about prognosis,
• 01:23:07not just about gestational age.
• 01:23:10We have about five more
• 01:23:11minutes, so time for maybe
• 01:23:13one or two more question.
• 01:23:15Oh, there's one. Great.
• 01:23:17Hello.
• 01:23:19So you talked about, kind
• 01:23:21of ECMO working as an
• 01:23:23analogy specifically for terminology.
• 01:23:25I'm wondering
• 01:23:26when
• 01:23:27ECMO was just starting up,
• 01:23:29like, in terms of consent,
• 01:23:31how did that look? You
• 01:23:32know, you discussed, like, do
• 01:23:34we need both parents to,
• 01:23:36consent for extend?
• 01:23:38Like, what was what's been
• 01:23:40done previously with ECMO?
• 01:23:42Now believe it or not,
• 01:23:43I was actually around when
• 01:23:44we first started getting consent
• 01:23:45for people for ECMO. But
• 01:23:47believe it or not, I
• 01:23:48did mention
• 01:23:49I hate to put people
• 01:23:50on the spot.
• 01:23:52Do you wanna speak to
• 01:23:52that? You want me to
• 01:23:53speak to that?
• 01:23:55You can speak to that.
• 01:23:55So it's a difficult question.
• 01:23:56I'll have it. Yeah. There
• 01:23:58we go. It's
• 01:23:59a difficult question if one
• 01:24:00parent wants the patient to
• 01:24:01go on ECMO and the
• 01:24:02other doesn't. So we don't
• 01:24:04have, like, a set policy
• 01:24:05that says if one does
• 01:24:06and one doesn't. We have
• 01:24:08to approach that individually and
• 01:24:09figure out what the best
• 01:24:11I think I think what
• 01:24:12we would do to start
• 01:24:13with again, this is Steve
• 01:24:14Pieterich, the guy who started
• 01:24:15the ECMO program at Yale
• 01:24:17and and has done more
• 01:24:18than anybody in the state.
• 01:24:19This is
• 01:24:23this is hard work. Right?
• 01:24:25And so what we would
• 01:24:26really do, not a satisfying
• 01:24:27answer for an ethicist, is
• 01:24:29what we really do is
• 01:24:30we work like hell to
• 01:24:30get the parents on the
• 01:24:31same page.
• 01:24:32Failing that,
• 01:24:34I'm not certain what we
• 01:24:35would do. It might depend
• 01:24:36on the situation.
• 01:24:38One thing interesting about the
• 01:24:39initiation of ECMO in the
• 01:24:41early days was it was
• 01:24:42chosen for patients who we
• 01:24:44thought had an eighty percent
• 01:24:45mortality rate. A twenty percent
• 01:24:47survival rate was how it
• 01:24:48was recommended,
• 01:24:49very similar to the numbers
• 01:24:50that your friends picked.
• 01:24:52That's that's really interesting. And
• 01:24:53I wonder if she if
• 01:24:54I didn't know that. I
• 01:24:55wonder if that's what she
• 01:24:56how she came up with
• 01:24:56that number. If I had
• 01:24:57read the article more carefully,
• 01:24:58I might know that. But
• 01:24:59that's helpful to know, Steve.
• 01:25:01But remember, and I know
• 01:25:02you know this better than
• 01:25:03I, Steve, when we started
• 01:25:04ECMO, when ECMO was first
• 01:25:06studying, it was the folks
• 01:25:07out in Michigan who said,
• 01:25:09take a look at kids
• 01:25:09whose whose oxygenation these are
• 01:25:11full term babies now. Their
• 01:25:13oxygenation index, which has to
• 01:25:14do with how much oxygen
• 01:25:15you're in, how low the
• 01:25:16oxygen in your blood is,
• 01:25:17and how high the settings
• 01:25:18on the ventilator are.
• 01:25:20Take a look at these
• 01:25:21kids.
• 01:25:22Once you reach this
• 01:25:24point, the this is so
• 01:25:25bad, their chances of dying
• 01:25:27are ninety percent.
• 01:25:29So we take these kids,
• 01:25:30we put them on that
• 01:25:31ball, and we save ninety
• 01:25:32percent of them.
• 01:25:34Well, that seems pretty convincing.
• 01:25:35Right? So at Yale, what
• 01:25:37we did, and it wasn't
• 01:25:38me, it was others I
• 01:25:39was working with, said, we
• 01:25:40take a look at those
• 01:25:41same kids here
• 01:25:43who have a ninety percent
• 01:25:45by your criteria,
• 01:25:46ninety percent chance of dying
• 01:25:48on conventional treatment. By the
• 01:25:49way, we save ninety percent
• 01:25:50of them. So we'll you
• 01:25:52have ninety percent mortality for
• 01:25:53those kids? We've got ten
• 01:25:54percent mortality.
• 01:25:56Is that because we're so
• 01:25:57smart?
• 01:25:58No. It's because
• 01:25:59we borrowed from Columbia, because
• 01:26:01Columbia had figured out a
• 01:26:02smarter way to ventilate these
• 01:26:04babies. So we changed to
• 01:26:05the point of the man
• 01:26:06back there about different ventilator
• 01:26:07strategies. We changed the way
• 01:26:09we ventilate full term babies
• 01:26:10with horrible lungs, and we
• 01:26:12had much better results. Meantime,
• 01:26:14the guys in Michigan are
• 01:26:15comparing the old way. And
• 01:26:17one result that came with
• 01:26:18that and, Steve, if I'm
• 01:26:19wrong, please feel free to
• 01:26:21embarrass me about this, honestly.
• 01:26:22But one thing that came
• 01:26:23of that was that the
• 01:26:24world jumped on the bandwagon
• 01:26:26with ECMO, and it was
• 01:26:27many years of using it
• 01:26:30before we actually had a
• 01:26:31good randomized trial demonstrating its
• 01:26:33efficacy. Is that a fair
• 01:26:34statement? Yes. He says yes.
• 01:26:35Because this isn't our first
• 01:26:36conversation with it. He's taught
• 01:26:38me a lot about this.
• 01:26:39So I don't want us
• 01:26:40to be in that same
• 01:26:41situation with the artificial wound
• 01:26:42technology where we're just on
• 01:26:44the bandwagon, wriggling, and no
• 01:26:45one's actually proven with a
• 01:26:46randomized trial that it's actually
• 01:26:48making things better.