Contemporary Pediatric Research Ethics: Lessons Learned from the COVID-19 Pandemic

Transcript

• 00:04OK, I think we're going to get started.
• 00:08Good evening, my name is
• 00:09Mark Mercury on director,
• 00:11the program for Biomedical Ethics
• 00:12and I want to welcome you tonight to
• 00:15our Evening Ethics seminar series.
• 00:17In looking forward to this talk for
• 00:19quite some time and I want to get to
• 00:22introducing our speaker in just a minute.
• 00:25Wanna welcome have myself on the associate
• 00:27director Jack Hughes and Serra Hall,
• 00:29as well as our program manager Karen Cole.
• 00:32Thanks so much for joining us to let
• 00:35you know how this works is we'll have a.
• 00:38Lecture someday the way it works is
• 00:39that we're on a big room together,
• 00:41eating good food,
• 00:42but for a little while longer we do
• 00:44it like this and we'll have a lecture
• 00:45that will last around an hour and
• 00:47then we'll have about 30 minutes
• 00:49or so for a question and answer.
• 00:51And and right now you're all muted,
• 00:53but when the time comes for Q&A will
• 00:55I'll explain to you how we're going
• 00:56to do that so you get a chance to
• 00:59ask your questions as we go sabi
• 01:01calling on you to ask the questions.
• 01:04We will stop at.
• 01:05We have a hard stop at at 5:30
• 01:07as those you excuse me.
• 01:09At 6:30,
• 01:09those of you who've done this with this
• 01:12before and no so I apologize in advance.
• 01:14Whoever has the best possible question at
• 01:16629 'cause you probably won't get to ask it,
• 01:19but come back,
• 01:19come back in a couple weeks and ask
• 01:22a question or the next session you
• 01:23can see in front of you there the
• 01:26calendar for upcoming talks and
• 01:27we're very excited about all of them.
• 01:29But then I want to talk about my friend.
• 01:32They only laventhol doctor Naomi
• 01:33Laventhol is a clinical associate
• 01:35professor of Pediatrics in the division
• 01:37of the United Perinatal Medicine.
• 01:38As well as in the Center for Bioethics
• 01:41and Social Sciences and Medicine at the
• 01:43University of Michigan Medical School,
• 01:45they only attended college.
• 01:47Indiana University and Medical School at LSU.
• 01:49She did her pediatric residency
• 01:51and neonatology Fellowship of
• 01:52Medical Ethics Fellowship an MPH,
• 01:54all at the University of Chicago,
• 01:56and since then,
• 01:57she's been up in Ann Arbor at
• 01:59the University of Michigan,
• 02:01where she's one of the leaders
• 02:03in the ethics endeavors there,
• 02:04as well as in neonatology.
• 02:07I am I've been working with Naomi
• 02:09off and on for years and I've been
• 02:12wanting to get her here and was
• 02:14delighted this year when she agreed
• 02:16to come such as it is to visit us.
• 02:19In this way they only,
• 02:21as part of the next generation of
• 02:23leadership in pediatric ethics.
• 02:24I will tell you that when the COVID-19
• 02:27pandemic was upon us in the spring,
• 02:29and several of us in pediatric ethics
• 02:31associated with the American Academy
• 02:33of Pediatrics decided that we needed
• 02:35to get together to try and write
• 02:37something that provide some guidance.
• 02:39With regard to triage,
• 02:40it was Naomi who led the
• 02:42effort and led the charge in coordinated US,
• 02:45and that was a work that was
• 02:47published with Naomi's first author.
• 02:49She's smart, she's hard working,
• 02:51and she gives a great talk.
• 02:53So we're in for a treat tonight.
• 02:55Tonight we're going to hear about
• 02:57contemporary pediatric research ethics
• 02:58lessons learned from the COVID-19 pandemic.
• 03:00Naomi I'm delighted you're here.
• 03:02Thank you so much for joining us take over.
• 03:06Well, that was a lovely introduction mark.
• 03:08Thank you so much.
• 03:09I'm going to go ahead and share
• 03:11my slides and get started.
• 03:12It is a pleasure to be here
• 03:14and you know when.
• 03:15When I was first invited to do this,
• 03:17I think we really were hopeful that
• 03:19that we would be able to do with this
• 03:22in person and that wasn't meant to be,
• 03:24but it's great to be here and you
• 03:26guys have a good setup. I am.
• 03:28Not able to see you guys right now
• 03:29so if something funny is happening
• 03:31someone beginning let me know.
• 03:33Can everybody see my slides OK?
• 03:37OK, I see you mark, thank you.
• 03:40Alright, so as I was saying before
• 03:42before the recording started,
• 03:43this is a new talk for me and it's a
• 03:45talk that I've really wanted to write
• 03:47for quite some time because it comes
• 03:49out of some ideas and questions that
• 03:50I've had throughout this pandemic.
• 03:52And I'll tell you that in other research
• 03:54I did to prepare this I thought I would
• 03:56find more answers than I ended up finding,
• 03:58and so I really hope that I leave plenty
• 04:00of time in the discussion for us to
• 04:02try to come to those answers together.
• 04:04I have nothing to disclose except
• 04:05as I mentioned earlier.
• 04:06I do have five and eight year old
• 04:08boys in the house right now, so.
• 04:10If you hear a loud crash, that's them.
• 04:12Um and I, did you know I've
• 04:14overtime is that given talks.
• 04:16I've tried to view this objectives.
• 04:17Idea is really not just like this is a
• 04:19thing I have to turn in for the CME,
• 04:21but you really think about what
• 04:23do I want to do with this time?
• 04:26And so today I'm really hoping
• 04:27that we explore key principles of
• 04:29research ethics that have emerged as
• 04:30important themes during this pandemic.
• 04:32And we're going to talk specifically
• 04:34about children and their unique
• 04:35aspects as a special population of
• 04:37research participants in general and
• 04:38in the context of this pandemic.
• 04:40And we're going to reflect a bit on
• 04:42the tensions related to racism and
• 04:43socioeconomic inequity as they relate to
• 04:45the historical context of research ethics.
• 04:47Clearly,
• 04:47that's several hours worth of
• 04:49talks unto itself.
• 04:49It's not my specific area of expertise,
• 04:51but I do think this is important as we
• 04:53think about the research ethics of this
• 04:55pandemic and about children in particular,
• 04:57even though the attention I will
• 04:59tell you hasn't really been
• 05:01on children with regard to.
• 05:02Uh, racial tensions and vaccine research.
• 05:06So here are the things we're going to
• 05:08do when I'm not necessarily going to go
• 05:10through through these things in order,
• 05:12but these are the ways we're
• 05:13going to talk about this.
• 05:15We're going to talk about
• 05:16principles that were reinforced.
• 05:17We're going to talk about new complexities
• 05:18that arose in public health ethics.
• 05:20We will talk a bit about race,
• 05:22racism and inequity,
• 05:23and will talk about children.
• 05:24I'm going to talk both about clinical
• 05:25trials and about pre approval access,
• 05:27which is something I had
• 05:28to learn a lot about,
• 05:30as as this pandemic going on.
• 05:31And if there's time,
• 05:32I'll talk a bit about research
• 05:33integrity and publication ethics,
• 05:35because there are some things that came
• 05:36out during this pandemic that are.
• 05:38I think are important,
• 05:39but if I have not gotten my timings
• 05:41right and it looks like that would cost
• 05:43us too much of the discussion time,
• 05:45I'll skip that for another day.
• 05:48Alright,
• 05:48so I start here with this picture
• 05:50of New Orleans.
• 05:51This is my hometown and what
• 05:52I'll tell you is
• 05:53that for the first time in about 20 years
• 05:55I was in this scrum with my family in 2020,
• 05:58and while we were in the scrum,
• 05:59at a certain point I looked around and
• 06:01I thought, gosh, it's a good thing.
• 06:03All these worries about
• 06:04coronavirus are overblown,
• 06:04or we're all really in trouble.
• 06:07And it turned out that we really
• 06:09were in trouble and I just have
• 06:11this year to sort of think about my
• 06:14own life is a private citizen and
• 06:15how this pandemic started for me.
• 06:17And, you know, we were lucky.
• 06:19We didn't get covid during this
• 06:20during Mardi Gras at last year,
• 06:22but a lot of people did because there
• 06:24wasn't a lot of warning about the
• 06:26seriousness of this pandemic as it was
• 06:28spreading out of Asia and there was
• 06:30there some public health opportunities
• 06:32that were missed in the lead up to Michael.
• 06:35But so to frame research ethics
• 06:37in the context of clinical ethics,
• 06:39my general way of thinking about
• 06:40this and this has really been my big
• 06:43approach to thinking about research
• 06:45ethics during this pandemic is that you know,
• 06:47as as Mark was saying,
• 06:49as we were writing these papers about
• 06:51resource allocation and workforce
• 06:52redeployment and shortages of PPE,
• 06:53those were things that we've
• 06:55never had to think about,
• 06:56or at least not so.
• 06:58Specifically,
• 06:58they were hypotheticals an we had to go
• 07:01back an do this normative re analysis
• 07:03of things that we thought we knew and
• 07:06rethink them in this modern world.
• 07:08And we this was really new and different
• 07:10for a lot of us and we had to pivot
• 07:12to thinking more deliberately about
• 07:14public health ethics that many of us
• 07:16have in our lifetime and children
• 07:18really occupied a unique and complex
• 07:20and often polarizing role in these
• 07:22considerations and the most polarizing
• 07:23role of children I can think of in
• 07:25this pandemic has been school closure,
• 07:27school reopening and what are we
• 07:28really talking about when we're
• 07:30talking about kids in this pandemic?
• 07:32And I do think that that recapitulates
• 07:34into the research ethics.
• 07:36So where is the clinical ethics
• 07:37in covid I think have let us into
• 07:40this really unchartered territory
• 07:41to mean research ethics has largely
• 07:43reinforced what we already knew and
• 07:45shown these principles that we already
• 07:47understood playing out logically in
• 07:48this modern time with modern technology.
• 07:50And I will say access versus protection
• 07:52several times in this talk because
• 07:54it keeps coming back to access
• 07:56versus protection an in my view,
• 07:58when you talk about yes.
• 07:59So
• 08:00sorry to do this, but I just got a
• 08:02text from a friend of mine in the
• 08:05audience that they can't see the slide.
• 08:07So I'm asking Kyle.
• 08:08Give us and give us just a few
• 08:11seconds here in Kyle if you could
• 08:13figure out why that is the case,
• 08:15I can see the slides just
• 08:17fine. Yeah, I can tell.
• 08:20OK so my buddy who knows who he is is
• 08:23something with your connection I guess.
• 08:26Thank you and I'm sorry to interrupt
• 08:28Ono trouble. Call you OK. Art over
• 08:32your doing. I won't so access
• 08:35versus protection again and again,
• 08:37and the unique vulnerabilities of
• 08:39children imparted moral and regulatory
• 08:42challenges to research ethics
• 08:44research uncovered for children.
• 08:46And our history and current
• 08:48struggles with racism and inequity
• 08:49wear sailing as they've ever been.
• 08:51But so so when I started writing this talk,
• 08:54I really thought there's nothing new here.
• 08:55But then I thought more about
• 08:57this public health ethics issue,
• 08:58and I think even in research ethics,
• 09:00there is a lot that's new.
• 09:03So after I've done all this myself,
• 09:05I found out that someone had published it,
• 09:08and after I've done my own
• 09:10diving into clinicaltrials.gov,
• 09:11I found exactly the figure
• 09:12that I was hoping to make,
• 09:14which is this dismal and hopefully
• 09:16drawing realization about how few of the
• 09:19interventional studies in for COVID-19
• 09:21have included children under the age of 17.
• 09:23I'll tell you almost none of them
• 09:26included children under the age of 12,
• 09:28but this to me as a pediatrician
• 09:30is really depressing.
• 09:31We just.
• 09:31Didn't include children in these trials
• 09:33and I think there were a few reasons
• 09:35about for that that will get to, but
• 09:37I want this is the framing of my talk is why?
• 09:40Why is this true?
• 09:41Was it the right thing was at the wrong
• 09:43thing and could we have done better?
• 09:45And so I'll say the thing I'll say
• 09:47again and again in this talk is that
• 09:49children should be protected by research,
• 09:51not from it.
• 09:51And I could kind of stop here,
• 09:53and we could probably spend the
• 09:54next hour and a half talking about
• 09:56whether or not we agree with this
• 09:58and how to make it so if it's true.
• 10:00One thing I want to be clear
• 10:01about is I read this phrase,
• 10:03sort of in relation to pregnant
• 10:04women saying that pregnant women
• 10:05should be protected by research,
• 10:06not from it, and so it's very clever,
• 10:08and I wish I'd said it first,
• 10:09but I want to be a friend
• 10:11that I didn't say it first.
• 10:15So this is a slide that I actually
• 10:18use quite a bit when I do.
• 10:20My introductory talks for students and
• 10:22learners about pediatric research ethics,
• 10:23and I've beautified it a little bit for you,
• 10:26but I'll start by saying this in the
• 10:29contemporary research environment.
• 10:30Enrollment in special populations
• 10:31is usually required, by which I
• 10:33mean it's a regulatory requirement.
• 10:35It's necessary morally,
• 10:36and that are the integrity of our science.
• 10:38Depends on it and that sometimes it
• 10:41really can be procedurally difficult.
• 10:44The big picture principle here is
• 10:46that research should be done with
• 10:48participants who stand to benefit
• 10:49or who represent populations
• 10:51that could benefit in the future.
• 10:53Now ethics,
• 10:53we say good ethics rely on good
• 10:55facts and I think it's also true that
• 10:57good medicine relies on good facts.
• 10:58And generally I think it's true
• 11:00that patients are better off when
• 11:01their medical care is informed by
• 11:03high quality scientific evidence.
• 11:04We shouldn't be excluding unique
• 11:06populations with unique complexities
• 11:07because it's difficult we shouldn't
• 11:09be excluding them.
• 11:10For convenience,
• 11:11we should be getting over that
• 11:13inconvenience and bringing them in.
• 11:14There are some specific regulatory
• 11:17and institutional considerations
• 11:18that we have to take into account.
• 11:20So again,
• 11:21access versus protection when you
• 11:22think about vulnerable populations.
• 11:24It's and research.
• 11:25The question is always going to be
• 11:26is research this fundamentally good
• 11:28thing that makes us all healthier?
• 11:30That's that we should want to be involved in.
• 11:33Or is it at its core dangerous
• 11:35and a little bit scary,
• 11:36and we should all be wary.
• 11:38And the answer clearly is yes,
• 11:40but you know to both.
• 11:41But I think this is the tension
• 11:43that comes up again and again.
• 11:45And as we've thought about this
• 11:47in the context of Covid an in the
• 11:49context of children that access
• 11:51versus protection balance.
• 11:52Stasin but.
• 11:57But um.
• 11:57There's also this other tension
• 11:59which suddenly I've lost the
• 12:01ability to show you hang on.
• 12:04Between individual child health
• 12:05and an public health more broadly,
• 12:07and I mean public health and
• 12:09the really big picture here.
• 12:10And thinking about what is the role
• 12:12of children in this pandemic and what
• 12:14moral obligation to children's have
• 12:16towards population health in general.
• 12:18In most situations.
• 12:18We don't think of children
• 12:20as owing adults much,
• 12:21but in this pandemic,
• 12:23in some sense kids were asked
• 12:25to do a lot for adults,
• 12:26and I think that's one of the most
• 12:29interesting ethical issues that
• 12:30come out of this pandemic for me.
• 12:33So I won't talk about all these populations,
• 12:35but just to remind you,
• 12:37there are some very specifically bend
• 12:39categories of special populations when
• 12:41it comes to research that children,
• 12:42pregnant women,
• 12:43incarcerated individuals,
• 12:44individuals with cognitive
• 12:45and motor disabilities,
• 12:46and we're increasingly aware
• 12:47of economically and socially
• 12:48disadvantaged persons as also
• 12:50being a special population.
• 12:51And when we say special population,
• 12:53I think it's important to be
• 12:55cognizant of what do we mean?
• 12:56We're generally talking about
• 12:58medically medical complexity or,
• 12:59for example, in the for the patients
• 13:02that mark and I take care of.
• 13:04Physiologic vulnerability,
• 13:05one thing I say about premature infants
• 13:07is that all of their organ systems are
• 13:10immature and that makes them vulnerable.
• 13:12Now vulnerability in a more legal and
• 13:14social sense has to do with the patients
• 13:16risk of being exploited or coerced,
• 13:18and this violates the fundamental
• 13:19principle that I'm sure we
• 13:21all in this group know about,
• 13:22which is that research should be voluntary.
• 13:24We also want to be clear that the
• 13:26people who are taking on the burdens
• 13:28of research are the same people who
• 13:30benefit and that we're not burdening
• 13:32one group while benefiting another.
• 13:33And this really I don't talk
• 13:35about can't very much,
• 13:36but this is where in our
• 13:37hearts we talk about cotton.
• 13:39We think about how people shouldn't
• 13:41be used as a means to an end.
• 13:43The problem with this is that once
• 13:45you get designated as vulnerable,
• 13:46that makes it harder for you
• 13:48to be in a study.
• 13:49That means you're not recruited,
• 13:50and that means the care that
• 13:51you get isn't informed by data
• 13:53that involved people like you,
• 13:54and that makes her care less good.
• 13:57The other thing is that we have to
• 13:59be really careful not to conflate
• 14:01vulnerability and stupidity,
• 14:03and I think one of the things that
• 14:05his anger pregnant women over the
• 14:07centuries is that pregnancy and it's
• 14:09sort of designation is vulnerable.
• 14:11Got misclassified as a state of
• 14:14cognitive impairment as opposed
• 14:16to physiologic vulnerability.
• 14:17So I'll talk very briefly about oversight.
• 14:20This is pretty dry,
• 14:21but I do think you have to
• 14:23think about this a little bit,
• 14:26especially as you think about vaccine shop.
• 14:28And generally speaking,
• 14:29HHS empowers individual institutional
• 14:31review boards to approve three categories
• 14:33of research involving children.
• 14:35This should be familiar to most people,
• 14:37but as we think about,
• 14:38we think about this in terms of
• 14:40balancing risk and potential benefit.
• 14:42An as a general rule,
• 14:44we don't get to do research that's
• 14:46risky for children and less they
• 14:48stand to benefit an in all situations.
• 14:50Research needs to be accompanied by
• 14:52formal informed consent by parents and
• 14:55a sense of children when possible.
• 14:57Now there are lots of situations in
• 14:59which we do allow for more risk than minimal,
• 15:02but here we have this pretty stringent
• 15:04requirement that there's anticipated
• 15:05benefit that's proportional to that risk.
• 15:07This is in my gut where I think most
• 15:09of the vaccine trials have fallen,
• 15:11although I will tell you I had
• 15:13a heck of a hard time finding
• 15:15that written down anywhere.
• 15:16There are other types of
• 15:18vaccine research which have,
• 15:19which has specifically not
• 15:21falling into this category.
• 15:22Finally,
• 15:23there is this funny sort of
• 15:24case in which there's a minor
• 15:25increase over minimal risk,
• 15:26and books and articles and seminars have
• 15:28been given over how do you quantify
• 15:30what exactly is a minor risk over minimal,
• 15:32and what does that look
• 15:33like and what kind of
• 15:35kid are we talking about?
• 15:37But we do allow for this little
• 15:39caveat of ultraism by children,
• 15:41and say that children can take on a
• 15:44little bit of risk to benefit children
• 15:46who are like them in the future.
• 15:49This is, I think,
• 15:50a really interesting idea and we do
• 15:52know from some studies that young
• 15:53kids are able to articulate a notion
• 15:55of altruism and understand this.
• 15:57So I think this is fundamentally good,
• 15:59but it's also quite nuanced.
• 16:01So I'm gonna pause here for a little
• 16:03bit of humor and tell you a story
• 16:04that just happened to me last week,
• 16:06and I thought this is great and
• 16:07I got permission from my friend
• 16:09to use these screenshots of text
• 16:11messages to send me in this talk.
• 16:12So this is my good friend who had
• 16:14her second vaccine a couple of last
• 16:15week and she said it was no joke.
• 16:17I had chills and muscle aches.
• 16:18I felt terrible,
• 16:19and it felt like a head covid.
• 16:20And before you get all mad.
• 16:22So I got mad all the time.
• 16:23When people say that having the flu
• 16:25shot is worse than having the flu.
• 16:26And I will tell you that this friend
• 16:28is my friend from Mardi Gras who
• 16:29actually did have covid so she didn't
• 16:31know what she was talking about,
• 16:32but you.
• 16:33So she tells me this and then she tells me,
• 16:35now blurted out,
• 16:35I've blocked out the name of her son here,
• 16:37but she says I'm trying to convince
• 16:39my son that he wants to do good
• 16:40for humanity and participate
• 16:41in the pediatric vaccine trial.
• 16:43But after seeing me yesterday,
• 16:44he's unwilling.
• 16:46This friend is not a pediatrician and
• 16:47I'm really proud of her because she
• 16:49really understood in her core that
• 16:51this thing called child dissent is a
• 16:52thing and her child isn't more than 10 or 11.
• 16:55But he had this sense that this was a choice
• 16:57that he was allowed to make and he said,
• 16:59Nah,
• 17:00I don't want to do it and she said
• 17:02I can't make you and I was proud of
• 17:04her and I was really pleased to have
• 17:06this very real life example of this
• 17:08kind of intuitive ascent discussion
• 17:10between a child and his mother about
• 17:12participating in research study.
• 17:13And so I once gave a 90
• 17:15minute talk on a sense,
• 17:16so I've gone way down this rabbit hole
• 17:18before and I've only got 1 slide on it here.
• 17:21But this is just to remind you
• 17:22that ascent in Pediatrics in 2021
• 17:24is much more nuanced than just
• 17:26getting a nod from the kid,
• 17:27or determine at what age you do
• 17:29this and what age you don't.
• 17:31What age you don't,
• 17:31and if you're going to be in the business
• 17:34of enrolling children in research,
• 17:35you really do have to think about how
• 17:37you're going to engage that child,
• 17:39how you're going to determine their
• 17:40assessment of what's going on,
• 17:42and how you're going to allow
• 17:43them to be active
• 17:44participants in this decision.
• 17:46And just to be very clear,
• 17:47ascent forms are not the way to do this.
• 17:51But getting back to the regulatory bit,
• 17:53there is this other category and
• 17:54this comes up with some versions
• 17:56of some sorts of vaccine research,
• 17:58which is why I wanted to bring it up,
• 18:00which is there are situations in which
• 18:02an IRB can look at the protocol for
• 18:04a child research study and say, wow,
• 18:06this doesn't fit neatly into any of
• 18:08those three categories and say HHS,
• 18:09you have to help me.
• 18:12There are two mechanisms by which HHS
• 18:14can then approve a study like this.
• 18:16One is by saying, actually no.
• 18:18On further review,
• 18:19this does mean one of the previous
• 18:21categories and the other is by
• 18:23saying the potential to address
• 18:25the health and welfare of children.
• 18:27In this scientifically sound study is
• 18:29so great that we will allow some risk,
• 18:31even though this doesn't meet some of
• 18:33the other categories we talked about.
• 18:35So I think that this is a really again
• 18:38interesting nod towards this sense that
• 18:40there are some cases in which children.
• 18:42Can do things for the good of community,
• 18:44even if there's a net risk
• 18:46to them in doing it.
• 18:48So to recap,
• 18:49all of this background stuff
• 18:50in pediatric research ethics,
• 18:52children should be protected by research,
• 18:54not from it.
• 18:55Healthy children may not participate
• 18:57in research protocols and telling more
• 18:59than minimal risk most of the time,
• 19:01but sick children may be permitted to
• 19:03participate in protocols involving
• 19:04slightly more risk if they may receive
• 19:07direct benefit or a vital information
• 19:09about their disorder can be gathered.
• 19:10Pediatric research requires
• 19:11stringent oversight is.
• 19:12I've just reviewed an this nice quote quote
• 19:15from her friend Renee Boss in Baltimore.
• 19:17Pediatricians,
• 19:18researchers,
• 19:18Arby's and parents must work
• 19:19together to refine and apply the
• 19:21principles of respect for persons,
• 19:23justice and medicines to children.
• 19:24I really couldn't say that better myself,
• 19:26so I didn't try.
• 19:29So I want to move now out of this classic
• 19:31example of clinical trials though,
• 19:34and talk about investigational
• 19:35therapies in pre approval access,
• 19:36because I think probably many of you
• 19:38like me got a crash course in pre
• 19:41approval access as this pandemic is gone
• 19:43and forgive me if this is too basic for you.
• 19:46I found that I really had to go back
• 19:48and understand this and there's some
• 19:50great folks at Penn who work on this
• 19:53a lot and this does apply to children.
• 19:55There are emergency use authorizations
• 19:57that have been granted for children,
• 19:58usually older kids.
• 19:59But I won.
• 20:00I distinguish expanded access
• 20:01and early use authorization as
• 20:03two mechanisms by which the FDA
• 20:05authorizes pre approval access.
• 20:06There are other ways that pre
• 20:08approval access can happen,
• 20:10but the other thing that's important
• 20:12here is this is not FDA approval
• 20:14and I encourage you to be really
• 20:16careful in which words you use
• 20:18when you talk about this because.
• 20:20An early use authorization,
• 20:22for example, is not an approval.
• 20:25So expanded access usually allows a
• 20:27drug or device that is currently under
• 20:30some kind of systematic evaluation
• 20:32to be made available to someone for
• 20:35who suffer who for some reason is
• 20:37not eligible to enroll in the trial.
• 20:40We often refer to this as compassionate use.
• 20:43Usually the way this works is that the
• 20:46drug company directly supplies the the.
• 20:48The drug of the device to the prescriber,
• 20:51without a middleman like the federal
• 20:53government, through some sort of
• 20:54boarding and four agreements,
• 20:56and even though this is technically speaking,
• 20:58not research and does not require
• 21:00an informed consent,
• 21:01there is usually you do need to
• 21:03get your IRB to sign off on this,
• 21:05and there's some reporting to
• 21:08the IRB that's required.
• 21:10And what I just learned is that the
• 21:11manufacturer can actually quite
• 21:12require additional information
• 21:13that the FDA isn't interested,
• 21:15but it's still not considered to be research.
• 21:17This is also not the same
• 21:19thing as right to try,
• 21:20which I'll come back to in a minute.
• 21:24So early,
• 21:24this authorization is
• 21:25actually pretty different.
• 21:26It's a different form of pre approval
• 21:28access in which that the FDA concludes
• 21:30that a product may be effective and
• 21:33that it's known and potential benefits
• 21:35outweigh the risks with a pretty low bar.
• 21:37And one thing that's really clear
• 21:39about this is that for a patient
• 21:41to get something under an EUA,
• 21:43this is a clinical decision.
• 21:45This is not a research decision,
• 21:47you know,
• 21:47as we're all getting our vaccines
• 21:49that are released under anyway.
• 21:51We're not signing.
• 21:52Research consents were not
• 21:54participating in a research study.
• 21:56And in the case of vaccines,
• 21:58Pfizer and Moderna for example,
• 21:59are supplying millions of doses to the
• 22:01federal government were supplying it to
• 22:03states who are supplying it to institutions.
• 22:05So the supply chain is also really
• 22:08different than under expanded access.
• 22:11So in the time of kovid,
• 22:13institutions about to decide whether
• 22:14or not they want how they are going
• 22:17to make EUA approval UA authorized
• 22:19interventions available to their patients,
• 22:21and they can choose to say we're only
• 22:23going to our patients to get this in
• 22:26the context of which about clinical
• 22:28trial and then this nice paper that
• 22:31accorded here at the bottom the authors
• 22:33talk about about appropriate limitations too.
• 22:35Too easy way use,
• 22:37and when it's justifiable to
• 22:39you to limit this to a trial.
• 22:41And usually this has to do with,
• 22:43you know,
• 22:44my favorite word and research ethics.
• 22:45Equipois.
• 22:46We're really not sure whether
• 22:47or not there's a net benefit to
• 22:50be derived from getting this.
• 22:51This can also be a way to make
• 22:53sure that these trials happen,
• 22:55because one thing we always have
• 22:56to worry about is once everyone
• 22:58can get something before the
• 22:59trials have been done to finish
• 23:01scientifically validating it.
• 23:02It's really hard to go back and
• 23:04randomize people after that,
• 23:05and so if you think it's really
• 23:07important that at some point
• 23:08this trial needs to be done,
• 23:10the way might be your only chance to do it.
• 23:14The problem with this is,
• 23:16on the one hand, you potentially answer
• 23:19the unanswered questions by bringing
• 23:21a higher level of scientific rigor,
• 23:23but there's concerns about
• 23:25voluntariness and fairness here.
• 23:28And so, particularly when we're
• 23:29thinking about using any UA in
• 23:31the context of limited supplies.
• 23:32So the only way you can get
• 23:35this is if you're in the trial.
• 23:38The plus side is that it solves your
• 23:40problem that FDA does not tell you
• 23:43anything about resource allocation.
• 23:44You know when when there isn't.
• 23:46Any way for convalescent plasma,
• 23:47and you know we had six doses for
• 23:49300 people who needed it or my.
• 23:52I don't want to send it,
• 23:53but might have benefited from it.
• 23:55FDA didn't tell us how to allocate
• 23:58our six doses.
• 23:59Using a trial can be one way to
• 24:00bring some structure and fairness and
• 24:02criteria to how to distribute those,
• 24:04but it does raise access to raise
• 24:07questions about whether there really
• 24:08is fair access to that trial and
• 24:11whether or not people are going to.
• 24:13Inadvertently be coerced into participating
• 24:14because they really want the thing.
• 24:15And that's the only way they can get it.
• 24:19So do you want to distinguish
• 24:21this from right to try?
• 24:22Because I think right to try is
• 24:25when people talk about only plus
• 24:27lay press and I had to go back
• 24:29and remind myself how this works.
• 24:31So right to try is even less regulated
• 24:34than an expanded access in which
• 24:36terminally ill patients can get things
• 24:38after a phase one trial without any
• 24:40further communication from the FDA.
• 24:42So there's no,
• 24:43there's no communication information back.
• 24:45This isn't I.
• 24:46There's no IRB checkpoint on this,
• 24:48and I think this was viewed as a
• 24:51strong thing for patient advocacy.
• 24:53My take on this is that we have
• 24:55to be really careful and I liked
• 24:57this description about it,
• 24:59but fundamentally,
• 24:59right to try had a lot to do with
• 25:02politics and not a lot to do with science.
• 25:05And if you think critically about
• 25:06the benefits from this,
• 25:07it's not really clear what right to try
• 25:09ads in the setting of compassionate use.
• 25:12An easy way,
• 25:13and there's been some really interesting
• 25:15and compelling writing I think about.
• 25:17About the unintended consequences
• 25:19of Rachel tries.
• 25:19So I really like this piece
• 25:21talking about how right to try
• 25:23can inadvertently exclude people
• 25:24from the kind of comprehensive and
• 25:26really high quality palliative care
• 25:28that's available in the 21st century
• 25:30and just a lot of writing about.
• 25:33When we start to make these drugs
• 25:35available like this in this unregulated way,
• 25:36are we really undermining what
• 25:38we owe to patients in terms of
• 25:39science and regulation of new drugs?
• 25:41So this is just food for thought.
• 25:43I haven't heard a lot of talk about,
• 25:45right,
• 25:45right to try in the context
• 25:46of covered specifically,
• 25:47but I thought this was a good opportunity
• 25:50to review pre approval access.
• 25:52And the question that has been bugging me
• 25:55for the last six months that I thought
• 25:58I was going to have answers for you.
• 26:01For as I came to this talk was how do we
• 26:04feel about kids and expanded access anyways,
• 26:07in particular for for COVID-19 infection
• 26:09and what do we think about kids getting
• 26:12recipe or convalescent plasma or
• 26:14monoclonal antibody as under anyway and
• 26:16I expected to find this deep and rich
• 26:19seam of writing by all the ethicists I
• 26:22know who are so much smarter than me.
• 26:25To explain this to me and I found that
• 26:27this really just hasn't been front and
• 26:29center in the minds of bioethicists
• 26:31right now, and there's a lot of potential
• 26:33reasons for that is one is no mark described.
• 26:36We've been really busy doing other things.
• 26:38You know.
• 26:39The other is that a lot of these trials
• 26:41do include kids as young as 12 in the
• 26:43ways usually don't grant permission to
• 26:45use the drug outside of those and ranges,
• 26:48so the other is just.
• 26:49It's not really an issue,
• 26:51but you do wonder about whether we
• 26:53should be imposing. I think different.
• 26:55Thresholds or what's the role of assent?
• 26:57For example,
• 26:58for a teenager to get experimental,
• 26:59convalescent plasma,
• 27:00and so I'm hoping that you guys
• 27:02will engage with me on this one.
• 27:04We're able to talk at the end of
• 27:06the session because I have been
• 27:08really trying to think about what is
• 27:10a framework to think about guiding
• 27:12pediatric clinicians about use of
• 27:14of pre approval access.
• 27:16Outside of the confines of cancer,
• 27:17which is when we usually talk about it,
• 27:19but unfortunately I don't have 10 nice
• 27:21editorials to share with you about this.
• 27:23'cause it doesn't seem like
• 27:25people are writing them.
• 27:27So now I wanna really shift
• 27:28gears and talk about the vaccine.
• 27:30'cause if you want to think about where is
• 27:32the money in pediatric research ethics,
• 27:33it is in vaccines which are at
• 27:35the heart of every pediatrician.
• 27:38So.
• 27:39I will admit that I have bristled at the
• 27:42term operation warp speed this whole time.
• 27:44There's something that about it that
• 27:46I don't like, a feel like it kind of.
• 27:49Is antithetical to what you want and
• 27:52methodical and careful research and
• 27:54that nothing involving human subjects
• 27:56research should be happen at warp speed.
• 27:59But now with two doses of vaccine in
• 28:01my arm and looking at this figure,
• 28:03I'm starting to wonder if maybe my
• 28:05approach to this is a little antiquated
• 28:07and I should view this as a good thing
• 28:10and a bad thing and I'll get back to
• 28:12operation warp speed in a minute.
• 28:14But this is just a comparison of
• 28:16previous historical viral epidemics
• 28:17and the time from first observation
• 28:19of the disease to having a vaccine.
• 28:21Ann and I just it really did happen
• 28:23at warp speed for stars coming too,
• 28:26and I think this figure shows it really well,
• 28:28I'm sorry.
• 28:29If the person who can't see it still
• 28:31can't see it, but the idea here is,
• 28:33you know, we've known about Merge for six
• 28:35years and we still don't have a vaccine.
• 28:38It was 15 years from it,
• 28:39took 15 years to get A Bola vaccine approved,
• 28:42and it wasn't like the laughable outbreak
• 28:44was the first of all app, right?
• 28:45We knew about it for a long time after
• 28:48that before that, and so this is really
• 28:50happening in an unprecedented way.
• 28:51And of course the research ethics
• 28:53was going to be a little different.
• 28:56So this is a refresher,
• 28:58an vaccine development and testing isn't a
• 29:00ton difference than other new drug testing,
• 29:02and then it goes through many phases,
• 29:05including laboratory and animal studies,
• 29:06in which you do in vitro and
• 29:08then in vivo and animals,
• 29:10and you apply for your Ind.
• 29:12An vaccine studies have the same Phase 1,
• 29:15two and three that other drugs do the
• 29:17same process for approval and licensure,
• 29:19but there are some additional
• 29:21steps here and a lot of these come
• 29:23out come from in the time of post
• 29:26licensure monitoring in vaccines.
• 29:28So we think about the classic
• 29:30phase four trials,
• 29:31in which we look at how these
• 29:33vaccines are functioning in public.
• 29:35But we also have systems in place for
• 29:37adverse event reporting for vaccines.
• 29:39There's a vaccine safety data
• 29:41safety data link,
• 29:42which is like spotty and told,
• 29:44but allows for this real coordination
• 29:46of vaccine adverse events.
• 29:48And there's also this really interesting
• 29:50history about the vaccine court,
• 29:51but so thinking about this you sort of
• 29:55wonder how warp speed can this possibly be.
• 29:58Some of the reason this happened quickly.
• 30:00Apparently in the time of Comet isn't
• 30:02just because we were so so so motivated,
• 30:04but also because of the nature of
• 30:06the RNA vaccine and just ability to
• 30:08speed this up in a different way.
• 30:10But it really is.
• 30:12Amazing and astonishing to think
• 30:13of how fast we went from first
• 30:16observation of COVID-19 disease to
• 30:18a vaccine in the arms of millions
• 30:20of people around the world.
• 30:24So this is where it starts
• 30:26to get really interesting.
• 30:27I think for children in vaccines and
• 30:29immediately when we think of vaccines
• 30:31are supposed to be for kids, right?
• 30:33That's this intuitive sense that
• 30:35vaccines are supposed to be for kids
• 30:37and our kids are home, darn it.
• 30:39And. And they can't go to
• 30:41school because of this pandemic.
• 30:42And couldn't we get them
• 30:44vaccinated and send them to school?
• 30:46And so this was so apparent so early.
• 30:48And it was so painfully out clear,
• 30:50so early that we were going to
• 30:52have a vaccine for adults months
• 30:54before we had it for kids.
• 30:56Amen, I learned a really
• 30:57interesting thing here.
• 30:58I learned this term called
• 31:00the age D escalation,
• 31:01which wasn't a term that I knew
• 31:03specifically which describes
• 31:04this intuitive walking down the
• 31:06age spectrum of vaccine testing,
• 31:07and I want to work through this with you,
• 31:10'cause I think it's kind of
• 31:12tricky and important,
• 31:13but generally speaking,
• 31:14it's the case for vaccines that Phase
• 31:161 two trials are conducted first
• 31:17in adults than in older children,
• 31:19and finally in progressively younger
• 31:21children as it becomes relevant.
• 31:22So for example,
• 31:23there's not a lot of reason to.
• 31:26Test HPV vaccine in the youngest kids
• 31:29right now. Epidemiology of the disease.
• 31:31The risk benefits of the vaccine.
• 31:33There's need to be calculated
• 31:34for each age group.
• 31:35The safety profile of all the
• 31:36factors need to be taken into
• 31:38account in deescalation,
• 31:39and this is due to this classic thing
• 31:41that we say in Pediatrics all the time,
• 31:44which is the kids aren't just little adults.
• 31:47Now,
• 31:47there are situations in which it really
• 31:49makes sense to vaccinate young children,
• 31:51because young children those are
• 31:53the ones who get this and so there
• 31:55you can raise a moral argument
• 31:57against testing a vaccine in
• 31:59an older patient population.
• 32:00If that population really won't
• 32:02derive any benefit from it.
• 32:03There are some situations,
• 32:05Interestingly,
• 32:05in which adults can do this for
• 32:07an altruistic reason,
• 32:08and a group of adults can say we
• 32:10think it's worth having some safety
• 32:13data in adults before we test this.
• 32:15In kids,
• 32:16understanding that we will
• 32:17never benefit from this.
• 32:18I don't have a good modern example of this,
• 32:21but I think this is an
• 32:23interesting moral idea.
• 32:25And there are some situations in which
• 32:27there just isn't a lot of scientific
• 32:29or moral validity in testing a
• 32:30vaccine in adults or older children.
• 32:32Some of this has to do.
• 32:34For example,
• 32:34if adults are previously vaccinated
• 32:36or previously immune to it exposures,
• 32:37there might be situations in
• 32:39which you can make a scientific
• 32:40case that you really have to
• 32:42test younger children first.
• 32:46And just drive home this point about
• 32:48children not being little adults.
• 32:50There's some data that they express
• 32:52different antibodies in different ways,
• 32:54and this is important in thinking
• 32:56about things like vaccine.
• 32:58It's also thinking important thing
• 32:59about the clinical trials for testing
• 33:02and I will say that I didn't find
• 33:04anything really in the in the literature
• 33:07talking about child participation
• 33:09in vaxin in the test in the clinical
• 33:11trials of covenanting tests,
• 33:13I just didn't see that anywhere.
• 33:16And there have been a lot of studies.
• 33:18If you look at what's currently
• 33:20in clinicaltrials.gov,
• 33:21there are a lot of studies of particularly
• 33:23rapid antibody type tests of children,
• 33:25and this difference an antibody
• 33:27expression might be a really good
• 33:28reason that you would want to include
• 33:30children and say an antibody test.
• 33:32Generally, the testing is pretty low risk,
• 33:34so it doesn't generate a lot of controversy.
• 33:39But this is where to me this
• 33:42gets so so interesting so.
• 33:44We are now desperate to get children tested
• 33:47and were desperate for a couple of reasons.
• 33:50One is that I think as people think
• 33:52about kids with unique vulnerabilities
• 33:53and even if the overall never.
• 33:56I haven't said this explicitly,
• 33:57but even if the overall burden of
• 34:00this epidemic seems to be low on
• 34:02kids and the kids don't seem to get
• 34:04sick and die as much as adults,
• 34:06parents of kids with a lot of magic
• 34:09medical frailty are terrified of this
• 34:11and really worry about about what if
• 34:13my child with chronic respiratory failure.
• 34:15Gets a terrible case of COVID-19 and
• 34:17becomes really sick and you can imagine
• 34:19how sailing at this was particularly
• 34:21the beginning of pandemic when it also
• 34:23wasn't clear that we were going to have
• 34:25ventilators for all those children.
• 34:27And so we do see a lot of push
• 34:29from parents who want this vaccine
• 34:31for direct benefit for their kid
• 34:33because they're so desperate for
• 34:34the child not to get covered.
• 34:36And in fact there are some some
• 34:38interesting claims coming out of China
• 34:40that one of their vaccines is testing.
• 34:42Really young kids,
• 34:42and I read this and my first response
• 34:45to this was why can they do it?
• 34:46And we can't and why clearly other
• 34:48people have got this right and have
• 34:50figured out that we should be trying
• 34:52to find a way to test younger kids.
• 34:54This is where I think this tension
• 34:56of individual and public health
• 34:58gets really interesting,
• 34:59and the quote on the right of the
• 35:01screen comes from that article about
• 35:03the Chinese vaccine and the trials
• 35:05of early kids and what they're really
• 35:07thinking of is how can we control
• 35:09this epidemic in our population?
• 35:10And is one way to do that to get
• 35:13younger kids vaccinated with quick?
• 35:14And this, I mean,
• 35:16talk about ripped from the headlines,
• 35:17this article.
• 35:18On the left I found yesterday
• 35:20talking about when we can expect
• 35:22results of the vaccine,
• 35:23but I just want to call
• 35:25your attention to this.
• 35:26For that, I've highlighted,
• 35:28which is vaccinating.
• 35:29Kids could be key to halting,
• 35:31spread and herd immunity.
• 35:32And this to me,
• 35:34that might be true,
• 35:35but I think that we really need
• 35:37to stop and reflect on this,
• 35:39because then we're not really talking
• 35:41about kids getting vaccinated,
• 35:42so they don't get covid and they
• 35:44don't get sick.
• 35:45We're talking about kids getting vaccinated,
• 35:47so their teachers and their parents
• 35:49and their grandparents in the bus.
• 35:51Drivers don't get sick and we
• 35:52can certainly make arguments for
• 35:54why children are better off when
• 35:56their parents are healthy and are
• 35:57better off on their parents have
• 35:59financial stability because they're
• 36:00not losing their jobs.
• 36:02So there are certainly.
• 36:03Lots of lines to direct benefit to
• 36:05kids for having this pandemic ends,
• 36:06but it's a little more direct and
• 36:08I really hope we can talk about
• 36:10this because in the in our
• 36:11discussion 'cause I find this to be
• 36:14incredibly complex and thought provoking.
• 36:16So again, you know I threatened
• 36:19to talk about this a lot and
• 36:21I'm talking about this a lot,
• 36:23but there's a great article
• 36:24that's still in the all you can
• 36:27get is the Word document version,
• 36:29but it's free access in Pediatrics
• 36:30from some of our lawyer friends
• 36:32talking about different ways
• 36:34that our regulatory body could
• 36:35approach vaccinating children,
• 36:37and at what stage of safety and
• 36:39efficacy should we be including
• 36:41children in these trials?
• 36:42And I think they find this really
• 36:45nice and tabular way of.
• 36:46Weighing out the pros and cons
• 36:49of a very conservative versus a
• 36:51very effective approach and the
• 36:53tradeoffs of slowing down vaccine
• 36:55into the arms of children, but.
• 37:00That on the one hand,
• 37:01but potentially having more risks,
• 37:03on the other hand.
• 37:05And I thought this was a great read.
• 37:08I thought this was really interesting
• 37:09and particularly this point about
• 37:11the risk to lots of public trust.
• 37:12If you get this wrong,
• 37:14and so there's really not one answer
• 37:16to what should the regulatory approach
• 37:17be to enrolling kids in vaccine trials?
• 37:19Or when is the right time to do it?
• 37:22But I think that some really smart
• 37:24and interesting people are starting
• 37:25to tease this out in a systematic way.
• 37:27That's going to help us think about this.
• 37:31So now I have to talk about the part
• 37:34of this that's the hardest for me,
• 37:36and it's the hardest for me.
• 37:38I think both because it's not a
• 37:39strong area of expertise for me,
• 37:41but also just because this has been so
• 37:44painful in America over the last year,
• 37:46and not only because we've seen
• 37:47these disparities now,
• 37:48but was we've been forced to contend with
• 37:50how long they've been there and how long.
• 37:53Race,
• 37:53racism and inequity have played a
• 37:55role in American research ethics.
• 37:57So this started coming out really early.
• 38:00This was a slide I made for my very
• 38:02early talks on Covid in the spring
• 38:04and summer when we were really talking
• 38:07about how are we going to grapple
• 38:09with the historical unease that the
• 38:11black community has with research
• 38:13in America and how are we going to
• 38:15be trustworthy and be transparent
• 38:17and make sure that we come up with
• 38:20a vaccine that people want to take?
• 38:23Informed by by studies that reflect
• 38:25who we are as a country,
• 38:27and this this has been such a
• 38:29deeply held fearing concern.
• 38:31I think even though most of the
• 38:33writing about this isn't about kids,
• 38:35but we really can't skip this part.
• 38:38And no where more than I think
• 38:41in this issue of recent research,
• 38:43is this issue of access versus
• 38:45protection more salient?
• 38:46And one thing that kind of gets under
• 38:48my skin a little bit is when I see
• 38:51these headlines that really boil
• 38:53this down to something like black
• 38:55community won't be in research trial,
• 38:58because Tuskegee and distrust.
• 38:59And that's not to downplay that deep
• 39:01and painful history of test Kyan,
• 39:03that mistrust that's been so so
• 39:06hard to recover.
• 39:07But I really think it's important
• 39:09to think about.
• 39:10Other ways that we have created and
• 39:12allowed for barriers of historically
• 39:14disadvantaged groups to be part of trials.
• 39:16And if you think about hidden costs
• 39:18of participating in research such as
• 39:20coming back to the hospital for extra
• 39:23research, paying for extra visits,
• 39:25paying for parking is a huge
• 39:27issue at my own institution.
• 39:28Buying lunch when you're at the hospital.
• 39:31If you have to travel far.
• 39:33Concerns about access to to poor health
• 39:35literacy or lack of information,
• 39:37and various ways that implicit
• 39:39biases play in this.
• 39:40It is certainly about mistrust and
• 39:42certainly about a nasty history,
• 39:44but it's also got a lot of other things.
• 39:47And the other thing is,
• 39:48it's about the funding pipeline,
• 39:50and it's about who gets funded an
• 39:52WHO is in a position to be funded,
• 39:55an how lack of diversity
• 39:57among principle investigators.
• 39:58Is part of the problem that.
• 40:00Impacts what gets funded,
• 40:02particularly the NIH.
• 40:03And so the issue of bringing the
• 40:05diversity to our trials and having
• 40:07our trial populations represent
• 40:09who we are in the country.
• 40:11It's really thorny and complicated,
• 40:13and all of the things that we've
• 40:15been talking about in this really
• 40:17complicated time in American
• 40:19history play out in research ethics.
• 40:23And one more thing to kind of bring this
• 40:26point home is just thinking you know.
• 40:29So black people make up about
• 40:3113% of the population in the US,
• 40:33but have accounted for 21% of
• 40:35the deaths of covid. And sadly,
• 40:37only 3% of enrollees in vaccine trials.
• 40:40This threatens the validity and
• 40:41generalizability of the trial, and.
• 40:44And you know, I won't belabor this any
• 40:46further, but this is not a small issue,
• 40:49and so I really like this.
• 40:50You know, I harped earlier about my dislike
• 40:52of the phrase operation warp speed,
• 40:54but I really liked this phrase.
• 40:56Trust could be earned more quickly by
• 40:58a collaboratively designed operation.
• 40:59Build trust with worthiness that matches
• 41:01the seriousness and scope of operation,
• 41:02Warp speed.
• 41:03And again,
• 41:03I couldn't have said it better myself,
• 41:05so I didn't try.
• 41:08But the sad so sorry before my sad thing.
• 41:11One of the things that's been really
• 41:13interesting is I think different
• 41:14approaches that that leaders in the black
• 41:17community have taken to addressing this,
• 41:19and one strategy has been to people
• 41:21in positions of leadership and sort of
• 41:23figures of respect and authority have said
• 41:26we're going to volunteer for these trials,
• 41:28and we think we owe it to ourselves
• 41:30and one another to be in these trials.
• 41:33And there's a big case that cost my eye.
• 41:36'cause I'm from Louisiana.
• 41:38But the presidents of two historically
• 41:40black universities in New Orleans said
• 41:42we were going to enroll in these trials,
• 41:44and we recommend that our student
• 41:46bodies do this too.
• 41:47And this was not met without controversy,
• 41:49and there was some some significant
• 41:51bash backlash from parents of
• 41:53students at these institutions.
• 41:54So this wasn't universally welcomed
• 41:55as a as a way to address this issue,
• 41:58but I find this to be interesting
• 42:01and thought provoking.
• 42:02But for all this,
• 42:04unfortunately the news isn't very good
• 42:06and this was a figure I found that
• 42:08thought I thought laid out really nicely.
• 42:11The proportion of people in different
• 42:12states who have been vaccinated
• 42:14who are black set up against the
• 42:16proportion of residents of that
• 42:18state for black and importantly,
• 42:20of the proportion of health care
• 42:22workers in that state who are black.
• 42:24And that's important when the people who
• 42:26have been vaccinated for health care workers.
• 42:28And as you can see here,
• 42:30we're not doing great here and.
• 42:32There are some states where
• 42:34we're doing better than others,
• 42:35but even in states where a huge proportion
• 42:37of health care workers are black,
• 42:39there are a very small fraction
• 42:40of people who've been vaccinated,
• 42:41and so to me,
• 42:42this says that our fears were warranted
• 42:44and we've got a lot of work to do.
• 42:46You know,
• 42:47we didn't solve this on the 1st pass,
• 42:49and we have a lot more work to do
• 42:52to figure out how to do better here.
• 42:54So if your question is what on Earth
• 42:57does this have to do with pediatric ethics?
• 43:00That's fair and I didn't find
• 43:02anything in the literature
• 43:03specifically in or in the Lane press really
• 43:06about children of color and vaccine trials,
• 43:08but I think there's no reason to think
• 43:10that they would be immune to this,
• 43:13and that the forces that impact their
• 43:15parents aren't going to infect them.
• 43:17And in the really compelling letter
• 43:19from the AP to the to the Health
• 43:22and Human services and the FDA.
• 43:25This difference in mortality among black
• 43:27Matlack Latin X children was highlighted,
• 43:29and I thought said really nicely.
• 43:31The population studied must reflect the
• 43:33racial and ethnic diversity of the US
• 43:35population and not exclude populations at
• 43:37risk that may greatly benefit from Maxine's,
• 43:40including children.
• 43:42So we know this is a vulnerability for us.
• 43:45We know that health disparities
• 43:47impact children in devastating ways,
• 43:49and we seem to not have quite,
• 43:52not quite not at all figured out what to do
• 43:55to realize the dream of the vaccine trials.
• 43:58Reflecting the diversity of this country.
• 44:02So I wish I had happier news on this.
• 44:04This is a little bit of a
• 44:06dark place to wrap up my part.
• 44:07My talking about vaccines but but I
• 44:09think this is this is part of what
• 44:11we've got to do together as ethicists.
• 44:13So finally,
• 44:14because I think I've got time to do it,
• 44:16I want to talk a little bit about research
• 44:18integrity in public publication ethics.
• 44:19I spent a lot of time on this for
• 44:22those folks who are who do this,
• 44:24I don't know if your program
• 44:25is is where people get this,
• 44:27but if you have a K award you're
• 44:28required to get 10 hours of in
• 44:30person training on research,
• 44:31ethics and integrity.
• 44:32Um and so at University of Michigan.
• 44:35RC TSA takes responsibility for making sure
• 44:37that all our categories get that training,
• 44:39and I teach it with my good friend Kate
• 44:42Spectre Baghdadi and we always have
• 44:44a lot of fun talking about research
• 44:46ethics and integrity and in the covid
• 44:48vaccine then the covid era I would say
• 44:52it wasn't fun but it was relevant.
• 44:55So when I teach people about falsification,
• 44:58plagiarism, fabrication,
• 45:00I use this like you know this lingo
• 45:05of too long didn't read and.
• 45:08Really. Just don't steal ****.
• 45:10Don't make **** up,
• 45:11don't change it and I've got
• 45:13permission from Doctor Mirror to swear,
• 45:15but I think it's important for this
• 45:16to be funny because it really needs
• 45:18to go in 'cause everyone says I
• 45:21would never do this.
• 45:21This could never happen to me.
• 45:23I know better this this won't happen and it
• 45:26happens and it happens over and over again.
• 45:29So we use the example of hydroxychloroquine,
• 45:30so all of you guys will remember
• 45:32the great hope about this at
• 45:34the beginning of the pandemic,
• 45:35and this cheap,
• 45:36widely available drug was going
• 45:37to be the Savior for this thing.
• 45:39And then you look at the cumulative
• 45:41trials and you see a peak in the
• 45:43spring of new trials and it starts
• 45:45to go down and you know.
• 45:46And then our hopes came crashing
• 45:48down and this just wasn't the panacea
• 45:50that we thought it was going to be.
• 45:53And if you follow this,
• 45:54it was super dramatic, right?
• 45:55It works, it doesn't.
• 45:56It works it doesn't it see if it's not,
• 45:58you know, and it ended up being
• 46:00this sort of 1 two punch of.
• 46:01It's not clear that it works,
• 46:03and it's also not clear that it's safe,
• 46:05but in the middle of all this.
• 46:08I started paying attention
• 46:09to this delightful website,
• 46:10an organization called Retraction Watch
• 46:12that is a group that that sort of its
• 46:15aim is to share with the public sort
• 46:17of the process of Journal retractions.
• 46:19How many get retracted and what
• 46:22happens when they get retracted
• 46:23and what I want to point out to you
• 46:26here is this is refreshed a couple
• 46:28of days ago Journal retractions
• 46:30to date an we had gotten to 62.
• 46:32This is a lot of retractions and
• 46:35this doesn't include some more
• 46:36benign versions of this and.
• 46:38People behind Retraction Watch have
• 46:40been looking empirically to say.
• 46:42Is there really an uptick in this?
• 46:44And it really seems like there
• 46:46is an that in this race to learn
• 46:49more about this pandemic.
• 46:51We've gotten a little sloppy sometimes.
• 46:54And if what you're thinking is,
• 46:56this happens to those disreputable journals
• 46:58that email me saying dear Leventhal,
• 47:00Naomi T.
• 47:01We would love to review your
• 47:03paper and publish it in two days.
• 47:05Think again.
• 47:06This happened to the New England
• 47:08Journal in The Lancet and you know,
• 47:10not too shabby journals.
• 47:11The you know the source of respect
• 47:13and dignity around the world.
• 47:15And both of them got into trouble with
• 47:18datasets that couldn't be verified
• 47:20and had to retract their papers.
• 47:22And this is a big deal.
• 47:24This is an overwhelmingly big deal.
• 47:27And.
• 47:27One of the other ways that this
• 47:31is a big deal is that.
• 47:34Retractions don't necessarily mean
• 47:35that people stop citing the articles,
• 47:37and there's a couple of reasons for this.
• 47:39Summer has to do with the whale.
• 47:41It searches show you whether or
• 47:43not something has been retracted,
• 47:44so like if you go to The Lancet it
• 47:47says in huge letters that it's red,
• 47:49but people cut corners in this area.
• 47:51A lot of the time,
• 47:53and it's actually the case that.
• 47:57Citing a reference that you haven't
• 47:58actually gone to and verified yourself
• 47:59is on the spectrum of plagiarism,
• 48:01but people tend not to think
• 48:02about it this way, and sort of,
• 48:04you know,
• 48:05if you if you're trying to cite something
• 48:07and you're in a hurry and you don't have it,
• 48:09'cause you know the reviewers
• 48:10wanted to decide it.
• 48:11You're like alright,
• 48:12fine.
• 48:12You might not follow those links
• 48:14to their logical end,
• 48:15and you might well be citing
• 48:17something that was retraction and
• 48:18not realize that you're doing it.
• 48:20And that's problem.
• 48:21If there is a question about the
• 48:24scientific integrity of the the.
• 48:26Of the paper that you're signing,
• 48:27I'm gonna pause just to say there's
• 48:28somebody in the waiting room.
• 48:29I'm happy to let them in but I don't know
• 48:32if I'm supposed to be the one doing that.
• 48:34So to wrap up on this,
• 48:36you know don't feel stuff,
• 48:37don't change stuff,
• 48:38don't mix them up the stuff up,
• 48:40but the other thing about research
• 48:42integrity that I just want to stay here.
• 48:45And this is true in so many ways
• 48:46as you are responsible for your
• 48:48own stuff and what happened with
• 48:50these retractions in The Lancet in
• 48:52the New England Journal was that
• 48:54they contractid with private data
• 48:56sources and then couldn't vouch for
• 48:57the sanctity of those data sources.
• 48:59But the same thing happens when you
• 49:01cite something that you haven't read.
• 49:03That's a failure to be responsible
• 49:05for your own check.
• 49:06And that, I think,
• 49:07is another is a is a authentic
• 49:10problem with research integrity.
• 49:12So thanks for granting me that it's a
• 49:14little outside of the scope of I think
• 49:16probably what you expected me to talk about,
• 49:17but I do think it's part of the cadence
• 49:19of research ethics of this pandemic,
• 49:20and so I'm I'm glad I got
• 49:23a chance to fit it in.
• 49:25But so I think this is where I can wrap
• 49:27up and we can have lots of time to talk.
• 49:30So to conclude,
• 49:31the COVID-19 pandemic is required.
• 49:33Reexamination of long established
• 49:34principles of research ethics,
• 49:35largely reinforcing the fundamental
• 49:36tension between advancing population
• 49:38health through rigorous science and
• 49:39acknowledging the inherent risks of research.
• 49:43I hope that you'll take away if you hadn't
• 49:46already that pre approval access requires
• 49:48particular attention and understanding.
• 49:50Come and join me in re examining the
• 49:53foundational ethical principles that inform
• 49:55the way we do research and think about
• 49:58this harsh light on the historical record.
• 50:00Version of children from research and
• 50:03the entrenched racism and injustice
• 50:05problems that have plagued our society
• 50:07for a long time and persist in 2021.
• 50:09Um public health crisis is also demonstrated.
• 50:12The complex role of children and
• 50:14infectious epidemic and raises
• 50:15questions without easy answers.
• 50:17It's really hard to know
• 50:19what our children owe us.
• 50:21And finally, when we go too fast,
• 50:23we make some mistakes and sometimes those
• 50:25mistakes are really deeply regrettable.
• 50:28So I'm going to wrap up there and
• 50:29leave my email address up for a second
• 50:31and my Twitter handle up for a second
• 50:33and then I'll stop sharing so I can
• 50:35see your smiling faces and hopefully
• 50:36we can have a great discussion.
• 50:45Thank you Naomi, that was terrific.
• 50:47Children should be.
• 50:49Make sure I remember this.
• 50:50This quote which is memory children
• 50:52should be protected by research,
• 50:54not from research that was at the exact.
• 50:57That's that's very memorable.
• 50:58I'll take the prerogative I get
• 51:00of asking the first question,
• 51:02but then I'm going to invite others in the
• 51:06way we're going to do this is you can.
• 51:10How you can raise your hand and then I will.
• 51:13Then my friend Kyle will then
• 51:15enable you to unmute yourself.
• 51:16Right now everybody's muted,
• 51:18but if you raise your hand that
• 51:20I call on you then you'll be able
• 51:22to unmute yourself and you can ask
• 51:24Naomi your question directly or
• 51:26share your comments about this.
• 51:27Lots of people on this call with
• 51:29with expertise in this area,
• 51:31so we're interested in hearing
• 51:32from all of you.
• 51:34Then I'd love to see people are
• 51:36formulating their questions is
• 51:38one of the things that struck me.
• 51:40During the early part of the pandemic
• 51:42and still to this day was the
• 51:45remarkable lack of centralized guidance.
• 51:46There was no president's Commission
• 51:48on Bioethics that there had better
• 51:50had been in the past.
• 51:52There was nothing like that to
• 51:53guide us in terms of how we write
• 51:56our critical care protocols right?
• 51:58Our triage protocols.
• 52:00Or our allocation protocols?
• 52:01Is there an analogy to be drawn here?
• 52:04When we try to figure out how much is
• 52:06a minimal increase in risk you know is there,
• 52:09is there a place that we could go in
• 52:11New Haven that people in Ann Arbor
• 52:13could also go to where someone is kind
• 52:16of made this judgment or adjudicated?
• 52:18Or is it every man for himself?
• 52:21Well, I think the answer is
• 52:22kind of in that there is,
• 52:24I think, our renewed pathway.
• 52:26An interest in centralized IRB,
• 52:28at least for multicenter studies,
• 52:29because one of the things that happens
• 52:32when each institution is on their own.
• 52:34Deciding. Well, I think this is a more
• 52:36than a minor increase above minimal risk,
• 52:39and you know, as one center will say,
• 52:41that another center will say
• 52:43it's not right because it is so
• 52:45subjective and it is hard to know.
• 52:47So at least within one multicenter trial.
• 52:49If you can have an expert IRB that.
• 52:52Is going to think about that
• 52:54one way for the whole trial.
• 52:56I think that can at least deal
• 52:58with that Inter institution
• 53:00variability in the way that people.
• 53:03And the way that people make
• 53:05these determinations about
• 53:06what's going to be approved, but.
• 53:08But to your point.
• 53:10I mean,
• 53:11I think what we had before for the this was
• 53:13the President's Commission on Bioethics,
• 53:15and that you know,
• 53:16the last,
• 53:16the administration that ended
• 53:18this morning was the first one
• 53:19in a long time that didn't have a
• 53:21president's Commission on Bioethics.
• 53:22And I do think that one thing that you
• 53:25could do is if it rose to the interesting,
• 53:27they serve at the pleasure of the president.
• 53:29But things could make it to
• 53:31the desk of that Commission,
• 53:32and they could do a deep dive
• 53:34and give a report.
• 53:35And so they did that, for example,
• 53:37when there was talk of testing
• 53:38a smallpox vaccine in children.
• 53:40And they wrote 150 page report on
• 53:42the ethical considerations of of the
• 53:44vaccine of a smallpox vaccine trial for kids.
• 53:47So you know,
• 53:47I think that this is an area where
• 53:50organizations like the AP can help.
• 53:52I haven't seen us too much of that,
• 53:55but you know,
• 53:55maybe mark you and I already stated.
• 53:58Now you know, I think some of the
• 54:00child advocacy organizations can,
• 54:01and there are some organizations within
• 54:03NIH that really focus on the research ethics,
• 54:06but.
• 54:07The every man or woman for them self.
• 54:11IRB approach to this I
• 54:13think is a huge problem.
• 54:15An contemporary research.
• 54:16So we, Marcella Nunez
• 54:18Smith is on our faculty.
• 54:20And who is President Biden's Co.
• 54:22Chair for his COVID-19?
• 54:23Will then transition communities
• 54:25for the leadership for the COVID-19
• 54:27effort we we've made this point
• 54:29with her an hopefully it eventually
• 54:31finds its way to the ears of some
• 54:33people who can respond and give
• 54:35us some of that central guidance.
• 54:38I want to invite Doctor Tom Murray too.
• 54:40Hung up on mutual here or
• 54:43askyouthere.com if you can.
• 54:45If you can unmute yourself,
• 54:46please ask your question.
• 54:50Hi I'm I was trying to show my face,
• 54:53I apologize I I can't do that.
• 54:55My name is I'm on my infectious
• 54:57disease physician who's been
• 54:58working a lot with covid.
• 55:00Thank you for such a thought provoking talk.
• 55:02Two different areas that really struck me.
• 55:04The first is I think one of the
• 55:06issues around vaccination and kids
• 55:08for this particular infection really
• 55:10relates to the quote you showed about
• 55:12who's getting the sickest and who
• 55:14is bearing the burden of disease.
• 55:15And so I actually have been one
• 55:18of the pediatricians in favor of
• 55:19starting with the adults because
• 55:21they bear the burden of disease and
• 55:23kind of working it back because.
• 55:25I don't think children are where the money
• 55:27is in terms of stopping this pandemic.
• 55:30I think there are other reasons
• 55:32around school and things like that,
• 55:34and I'm all in favor of vaccination
• 55:36of children. But I do think.
• 55:39The Epidemiology of this disease is very
• 55:42different than something like influenza.
• 55:44Where we know kids are the cesspool.
• 55:47The second thing.
• 55:48So this is going to be totally
• 55:51unrelated thing,
• 55:52but with respect to the EUA data,
• 55:55I just pulled it up while you were
• 55:57talking about the distribution of who
• 56:00were in those trials and they did do
• 56:03a reasonable job of representing the
• 56:05US population in the Moderna trial
• 56:08it was 10% black and 20% Hispanic.
• 56:10The challenge I think has been
• 56:13translating that and helping.
• 56:15Get people to trust that we
• 56:17can provide this vaccine.
• 56:19So even if you're doing a better
• 56:21job of enrolling the right
• 56:23people in the clinical trials,
• 56:25it's not translating to getting those
• 56:28populations that need the vaccine the most.
• 56:31To have the trust to get it so
• 56:33I'm wondering what your thoughts
• 56:35are around even when you have a
• 56:37reasonable distribution of population,
• 56:39how to translate that into
• 56:41better vaccine uptake?
• 56:43Thanks for both of those comments,
• 56:45which are both really good and and helpful.
• 56:48And yeah, I think that.
• 56:51It does seems you know,
• 56:52the more we know about this,
• 56:54the more it seems like the people
• 56:56you know lives are saved by keeping
• 56:59adults from getting COVID-19.
• 57:00And I I didn't exactly mean to give
• 57:03the impression that I think it was a
• 57:05miscalculation not to include children.
• 57:07I actually think the most
• 57:09interesting thing is that even now,
• 57:11as we're including children that still
• 57:12with an eye on general infection
• 57:14control more than saving child lives.
• 57:17But so now your point about
• 57:20that as well taken.
• 57:22And you know that thanks for the
• 57:23clarity on the way for the moderna,
• 57:25I think that that is.
• 57:27That to me I think is such a recapitulation
• 57:29of what a major problem we have.
• 57:31In that quote I shared about,
• 57:33you know,
• 57:33sort of that operation.
• 57:35Build trust that should have gone along
• 57:37with operation work speed so you know
• 57:39my thoughts about this is is a bit that.
• 57:42We still have so far to go.
• 57:44I do think some of these you
• 57:46know these public campaigns I I
• 57:47didn't have time to fit this in,
• 57:49but there's a big push among black
• 57:51physicians to tweet out their
• 57:52pictures of themselves getting
• 57:53their vaccines and key leaders.
• 57:55You know,
• 57:55I think that was really what drove those
• 57:57presidents of Xavier and Dillard to say.
• 57:59We're going to be in these trials.
• 58:01And this is this is good for us.
• 58:03So I guess you know,
• 58:05if you look at that figure I showed
• 58:07about just the uptake rates.
• 58:08I guess it hasn't been as fruitful as
• 58:10we were hoping it was going to be, but.
• 58:13I think that needs to come from
• 58:16every angle we can think of to,
• 58:18really.
• 58:20Think about how do we move on from
• 58:22this really painful history and and
• 58:25overcome the barriers to getting
• 58:26our whole country to believe that
• 58:29this vaccine is safe for them.
• 58:32You know Stephen Thomas at University
• 58:34of Maryland was a speaker in
• 58:35this forum earlier this year.
• 58:37It's a name that either or both
• 58:39you might want to consider in
• 58:41terms of rebuilding trust.
• 58:43And he is. Interested in an,
• 58:47he's actually piloted a program
• 58:48going into particularly of Barber
• 58:50shops that are primarily for African
• 58:52American men and also salons for
• 58:54there primarily for American women.
• 58:56And he thinks that this is where so
• 58:58much of the culture happens where so
• 59:00much of the trust is actually built,
• 59:03and so he's actually piloted.
• 59:04This program. It's, and it was.
• 59:06It was about trying to get people
• 59:08to participate in clinical research
• 59:10projects about trying to get
• 59:12people to get tested for kovid,
• 59:14and so he gave a great presentation here,
• 59:16which I think is available on our website.
• 59:19But but stay tuned,
• 59:21you're going to hear from more from
• 59:23from Stephen Thomas on this in the
• 59:25work he's doing to rebuild that trust.
• 59:27And there are some interesting,
• 59:28you know when you think about a
• 59:30disease where the hallmark of of of
• 59:33saving lives is not congregating,
• 59:34how do you get that sort of community
• 59:37participation when people aren't going
• 59:38to church and they're not there aren't
• 59:40as many of them in that barbershop,
• 59:42and you know, not being able to get
• 59:44groups of people together to sort
• 59:46of rally that enthusiasm? That's it.
• 59:48That's another barrier to doing that, but I.
• 59:51My intuition is that he's on the right.
• 59:53You know him clearly knowing much
• 59:55more about this than me that getting
• 59:57to people where they are in settings
• 59:59that they feel comfortable is how you.
• 01:00:00Start to build that
• 01:00:02trust again. Yeah,
• 01:00:03that seems to show promise now.
• 01:00:04Charles Hughes has a question for us
• 01:00:06here so I'm gonna unmute Charles.
• 01:00:12Charles, you should be able to
• 01:00:13unmute yourself now and then.
• 01:00:18I'm trying to hear me.
• 01:00:20Yeah, OK we can. My question is,
• 01:00:22even if you get kids to consent to
• 01:00:25being tested to be affecting trial,
• 01:00:27what about the power relation?
• 01:00:29I mean you got a kid being confronted
• 01:00:31by parents and doctors saying you
• 01:00:33believe we really need you this
• 01:00:35the population here with do they
• 01:00:37really have conformed consent
• 01:00:39or or do they feel pressure?
• 01:00:43Yeah, I mean that I think is,
• 01:00:45you know we got lots and lots
• 01:00:46of ethics concepts about this.
• 01:00:48I think that. This.
• 01:00:53This is where ascent has to
• 01:00:55be a meaningful process.
• 01:00:56Just like informed consent
• 01:00:58isn't signing a form,
• 01:00:59it's a conversation you know.
• 01:01:01Really, I think taking the time if you can,
• 01:01:04if you can achieve it.
• 01:01:07Getting that child sort of alone in
• 01:01:10the room like we do in our lesson
• 01:01:12visits and sort of asking them and
• 01:01:14giving them that opportunity to.
• 01:01:16To the eye,
• 01:01:17the contemporary thinking about
• 01:01:18ascent really has to do with this
• 01:01:20read back and that it's not that
• 01:01:22the kid nodding is insufficient and
• 01:01:24that they need to sort of tell you
• 01:01:27these affirmative things you know,
• 01:01:28and I think that that is always.
• 01:01:32That is always an issue,
• 01:01:33whether the parent really does want
• 01:01:35the child to enroll or not is sort of.
• 01:01:37Can that child really say no,
• 01:01:38but that I think the onus of that
• 01:01:40is mostly on the research team
• 01:01:41to be as careful and thoughtful
• 01:01:43about about that as they can,
• 01:01:44and also weighing risks.
• 01:01:45So when someone pointed out to me
• 01:01:47about my friends example about,
• 01:01:48you know my son doesn't want
• 01:01:50to be in the vaccine trials.
• 01:01:52'cause he saw me being so miserable.
• 01:01:56She probably you know he's going to
• 01:01:58get vaccinated eventually, right?
• 01:01:59And so on.
• 01:02:00Some level like the I worry a
• 01:02:02little bit less about coercion for
• 01:02:04something that he will get eventually.
• 01:02:07But yeah,
• 01:02:07I think that that is an
• 01:02:09incompletely answered question,
• 01:02:10but the age of modern
• 01:02:13understanding of assent and really.
• 01:02:15Sufficient by and I mean I
• 01:02:17still see things about like.
• 01:02:18This is our sent former.
• 01:02:19This is where they sign or
• 01:02:21they have to be 14.
• 01:02:23So I think as we lean into this
• 01:02:25more nuanced and sort of laborious
• 01:02:26way of determining a child's
• 01:02:28emotional readiness to give assent
• 01:02:30will get better at better and
• 01:02:31screening for that sense of this
• 01:02:33kid doesn't really want to do this,
• 01:02:35but it's a.
• 01:02:36It's a good question that I
• 01:02:38don't have a short answer for.
• 01:02:41Thank you.
• 01:02:45OK, thank you. Still thank you.
• 01:02:48Um, I'm looking at that.
• 01:02:50I see no other questions at this point.
• 01:02:54This is a. This is a huge problem going
• 01:02:58forward and what I think is an important
• 01:03:01thing which I think most people on
• 01:03:04this call can appreciate is is this
• 01:03:06isn't this isn't just about COVID-19,
• 01:03:08but COVID-19 is afford us the opportunity
• 01:03:11to take a hard look at how we do
• 01:03:14things and you know, we sometimes,
• 01:03:16especially when we're really under the gun.
• 01:03:19You know the old thing that there
• 01:03:21are no atheists in foxholes.
• 01:03:23I have used the comment as we
• 01:03:25were rushing in the spring.
• 01:03:27To try and get a triage protocol
• 01:03:29prepared very quickly as you don't,
• 01:03:31it seems that there's no
• 01:03:32contents in foxholes, either.
• 01:03:33We all became utilitarians in hurry.
• 01:03:35We changed the way we looked at things.
• 01:03:37Some of us did I think,
• 01:03:39to some extent,
• 01:03:40but we felt the pressure of the enormity
• 01:03:42of the problem as well as the the
• 01:03:44speed at which we needed the answers.
• 01:03:46So so many people in publications
• 01:03:48and their clinical research.
• 01:03:49It's the same thing.
• 01:03:50So the lessons here, Naomi as your title is,
• 01:03:53is that if you talk to so actors,
• 01:03:55it's not just about COVID-19,
• 01:03:56but lessons learned from that.
• 01:03:59It will apply to other things
• 01:04:01as we move forward.
• 01:04:03So much to be learned.
• 01:04:04This has been a great
• 01:04:05talk and a great evening,
• 01:04:06and I want to thank Doctor Leventhal
• 01:04:08so what's supposed to happen now?
• 01:04:10Naomi's I'm supposed to take
• 01:04:11out a few of us taking up for
• 01:04:14a wonderful New Haven dinner.
• 01:04:16So now we officially owe you 1 when you
• 01:04:19already you will recall owed me a.
• 01:04:21What was it? A pina colada?
• 01:04:24So sad, because that was in the spring
• 01:04:26when we were scrambling all of us to
• 01:04:28get the prepared for the charges,
• 01:04:30and I said well by the fall
• 01:04:32meetings this is fall of 2020.
• 01:04:33I said well, by the fall meetings,
• 01:04:35which were going to San Diego,
• 01:04:36the AP meetings were all going
• 01:04:38to relax and have Pina coladas
• 01:04:40and talk about the war,
• 01:04:41and you know and how it went,
• 01:04:43but as it turned out in the fall,
• 01:04:45we were still not even all
• 01:04:46the way into the war, much
• 01:04:48less through it. Yeah, so Mark,
• 01:04:49I think our talk about drinking
• 01:04:51together has prompted someone else to
• 01:04:53make us stop and ask another question,
• 01:04:54good. Let me see if I can if I can
• 01:04:57get myself to this and he would have.
• 01:05:00It's Tom OK Tom please. Yeah,
• 01:05:03I'm sorry I I would much rather go
• 01:05:05out drinking, but there was one other
• 01:05:07thing you brought up that I thought
• 01:05:09was really interesting and I love your
• 01:05:12insight on and that is even in the.
• 01:05:14Slide that you showed with
• 01:05:16the retracted papers.
• 01:05:17Several of them were from metrics
• 01:05:20and from the non peer reviewed.
• 01:05:23Journal depositories that
• 01:05:24you can make anything on.
• 01:05:26It's not peer reviewed,
• 01:05:28and then it goes on and gets cited
• 01:05:30subsequently in peer reviewed literature.
• 01:05:33I just wondered.
• 01:05:34Kind of what you think about that,
• 01:05:37and whether those are good.
• 01:05:38I mean, I know why they're out there,
• 01:05:41but I also see a potential downside.
• 01:05:44Yeah, I mean it's really.
• 01:05:47We are in this very strange time of I
• 01:05:49think publication integrity and ethics,
• 01:05:51and you know, I I spend time talking about
• 01:05:54how we came to have peer review at all,
• 01:05:57which came out of when scientific
• 01:05:59proceedings stop being housed
• 01:06:00in monastic libraries, right?
• 01:06:01So we got a printing press.
• 01:06:03We can circulate the the mark.
• 01:06:05You would enjoy this I think
• 01:06:07for your historical history,
• 01:06:08medicine stuff.
• 01:06:09But we gotta we gotta printing
• 01:06:11press suddenly everyone can share
• 01:06:13their scientific findings widely
• 01:06:14in the scientific community
• 01:06:16and a little bit of like.
• 01:06:17Slobbering, snobbery,
• 01:06:18and wanting to control this says,
• 01:06:19no, no, we gotta make sure we're
• 01:06:21controlling the quality of this.
• 01:06:23And the interesting thing is the move
• 01:06:24to an even more accessible format,
• 01:06:26right?
• 01:06:26So, like you know,
• 01:06:28one as the print Journal has been going
• 01:06:29down an online only journals or only
• 01:06:32everywhere you know the democratization of
• 01:06:34this might end up being our undoing right?
• 01:06:36And you do have.
• 01:06:37I mean, I really do.
• 01:06:38I mean, I'm sure you guys get them too.
• 01:06:41I get, I think 10 to 20 invitations today,
• 01:06:43too.
• 01:06:43You know, they will,
• 01:06:44too.
• 01:06:45Submit my article that they seem
• 01:06:46to think I just have ready to go
• 01:06:49that they will peer review and
• 01:06:51get me a decision on in 48 hours.
• 01:06:53Right,
• 01:06:53and so whether it's peer reviewed at
• 01:06:55all or fake peer reviewed, I think.
• 01:06:59How do you?
• 01:07:01What is the history of the good
• 01:07:03quality lit review with sort
• 01:07:05of like all these walls down?
• 01:07:07But again, I mean if you're.
• 01:07:10I mean,
• 01:07:11when I read a paper I look
• 01:07:13at where it was published,
• 01:07:15write an when I'm deciding
• 01:07:16on citing something,
• 01:07:17I look at where is published
• 01:07:18and I try to discern between,
• 01:07:20you know,
• 01:07:21'cause sometimes things by
• 01:07:22famous people on important topics
• 01:07:24or publishing really weird
• 01:07:25journals and you know.
• 01:07:26And sometimes I think like wow,
• 01:07:28they must have just like submitted
• 01:07:30and resubmitted until they found
• 01:07:31someone to take this and that
• 01:07:33happens to everybody versus
• 01:07:34what's wrong with this paper
• 01:07:35that this is where it is right?
• 01:07:37And so I will say that when
• 01:07:40you write up the sort of.
• 01:07:41The right answer is when you write a paper,
• 01:07:44you're responsible for your citations.
• 01:07:48My dismay is that.
• 01:07:50Editors seem to have put the
• 01:07:54job of looking for this. Um?
• 01:07:58An entirely on the backs of peer
• 01:08:00reviewers and not taking a lot
• 01:08:01of responsibility for themselves.
• 01:08:03And so when you look at this,
• 01:08:04it seems like so now as a peer reviewer,
• 01:08:07I'm supposed to run every
• 01:08:08single citation myself,
• 01:08:08and you know, see if it it checks
• 01:08:10out as a real publication.
• 01:08:12I mean, like I don't have time
• 01:08:13to do that as a peer reviewer,
• 01:08:15I do a lot of peer review.
• 01:08:17You know,
• 01:08:17I'm I'm reading the paper to see if
• 01:08:19I think it's good and if I happen
• 01:08:21to Nova reference that I want to see
• 01:08:23or I'm curious about a reference outlook,
• 01:08:24but I can't cross reference all that,
• 01:08:26so I think.
• 01:08:27We're gonna have to answer the
• 01:08:29question of whose job is it?
• 01:08:31And you know,
• 01:08:32my sense is we're headed for some rules,
• 01:08:34and that journals will start to
• 01:08:36say these are our requirements
• 01:08:38for your bibliography.
• 01:08:40Um, but I hadn't thought about
• 01:08:41that much from that perspective,
• 01:08:43so thank you for that.
• 01:08:44'cause I think that is a.
• 01:08:47It's so hard to know now what's a
• 01:08:50quality reference and what's not.
• 01:08:54It's a little bit scary
• 01:08:56asking these things. Yeah,
• 01:08:58I think so too.
• 01:08:59Publication ethics is like super
• 01:09:01interesting stuff these days.
• 01:09:02There's like a lot of.
• 01:09:04Cool things to do in that area, I think.
• 01:09:07And there's just so many ways to mess up and
• 01:09:10so many ways to mess up by accident,
• 01:09:12I think, is the other.
• 01:09:14Other big thing you know,
• 01:09:16I think when people cite a reference
• 01:09:18that they haven't checked.
• 01:09:19That's sloppiness, not malice.
• 01:09:21Right, and so an it's a sort of
• 01:09:24particularly problematic kind
• 01:09:24of Attribution that we all do.
• 01:09:26'cause we're in a hurry, right?
• 01:09:27Not because we're trying to
• 01:09:28pull one over on someone.
• 01:09:32Excellent point, excellent point.
• 01:09:34Well, I think.
• 01:09:35Are scanning quickly over my list here?
• 01:09:38I think folks who wanted to speak
• 01:09:40at the opportunity to speak it was a
• 01:09:43wonderful talk and they only we look
• 01:09:45forward to hosting you in person.
• 01:09:47New Haven after the storm.