This episode is a continuation of the last episode. Lucia Arico-Muendel speaks with Dr. Valerie Flaherman more about her research on infants in low- to middle-income countries, focusing on ethical considerations, COVID complications, results and next steps.
Dr. Flaherman is a pediatrician and global health researcher at the University of California, San Francisco. Her research focuses on breastfeeding, breastmilk, lactation, and infant nutrition, overall aiming to improve health outcomes in at-risk infants through targeted interventions. She travels to Uganda, Guinea Bissau, Pakistan, and Nepal to set up studies with partner institutions.
Transcript (via Sonix)
Lucia Arico-Muendel: [00:24:27] Ok, let’s see. Did you ever have an infant with a particularly negative reaction to the treatment? And if so, how did you handle that? Or did you ever have a mother choose to break away from the assigned regimen? And how did you handle that?
Dr. Valerie Flaherman: [00:24:53] Yeah, yeah. So that’s actually an important part of our protocol is that we, we want to acknowledge that when we tell people to exclusively breastfeed or to breastfeed with one bottle of formula a day, people are busy. They have other things in their lives. They just had a baby, you know, so they don’t always, you know, comply. I don’t want to use the word line because our goal is not really for them to comply. This is what we’re recommending. So a key part of PRIMES is that we’re not testing what the effect of exclusive breastfeeding or the effect of one bottle of formula a day is. We’re testing what is the effect of the recommendation to exclusively breastfeed or the recommendation to give one bottle of formula a day. And the reason I think that’s important is we know from our preliminary data in the study, we talked about in the beginning that that when we as part of that study where we measured babies over the first 30 days, we asked mothers what they had fed their baby during that time. And even though these mothers had received a recommendation to exclusively breastfeed, people gave the heck. All kinds of, you know, mushroom soup to me, tea. An economy which is actually a prohibited food for infants in the U.S. because it has botulism spores, alcohol people gave it, I mean, to get them to
Lucia Arico-Muendel: [00:26:39] Sleep or something.
Dr. Valerie Flaherman: [00:26:41] Means of things to know that just telling people to feed their baby something is not does not result in. And it’s not just primates that knows that if you look in any of the literature, people do all different kinds of things when it comes to infant feeding. So just being really clear with the mothers that we were recommending this, but they’re not required to do anything. And if a mother, it’s part of our protocol that if a mother does decide that she doesn’t want to do the formula at all, then we still continue to baby remains in the study unless the mother. Well, first of all, of course, every mother is free to withdraw from the study at any time. Ok. And that’s really important, and I’m really proud of our both of our teams have had withdrawals. And I think that’s really important because I think that shows that they are mothers feel free to say what they actually want to do, and they don’t feel coerced because that’s really important. Yes. And then I think. Uh, another thing that that is important is that if a mother stays in the study and she just doesn’t feel like doing the Formula one day or she’s in the other group and she wants to give formula, the study doesn’t stop her from doing those things. She can continue to, uh, she can. She can continue to be in the study if she wants to. Ok, OK.
Lucia Arico-Muendel: [00:28:25] So what’s important is that you can just keep track of any of these like, um, like instances where people stray from their.
Dr. Valerie Flaherman: [00:28:35] Yes, you asked them about it. Yeah, yes. And you can tell
Lucia Arico-Muendel: [00:28:38] Us, yeah. And I imagine it’s important that whoever is asking them isn’t passing any sort of judgment. Just very neutral. Yeah. So how do you achieve that? Because I feel like that could be tricky.
Dr. Valerie Flaherman: [00:28:54] I think I I honestly, it’s our teams that that do that and the I’ve, you know, I’ve had the opportunity to watch them many times talking with the moms and having discussions of various kinds. And I just am in awe of I just feel very fortunate to be working with these incredible teams. I’ve I’ve been with them when the mother has said, I’m busy today, I’m not interested, you know, and they’re so gracious. And I think it’s because they, the teams are so connected with their communities and because of the just what I I think is very high ethics of our partnering teams that you know, that they don’t want to they don’t. It’s being like open to whatever the moms want. Yeah, is is really integral to how they both these teams conduct their research. So I think I just feel very fortunate and I don’t think everyone is like that. But the people that I’ve worked with have been so I feel really lucky.
Lucia Arico-Muendel: [00:30:12] Yeah, that’s wonderful. Yeah, something we’ve definitely talked about in some of my global health or medical anthropology classes is how would you enter a different country, perhaps lower middle income country with all of your experience, academic experience and incorporate like traditional or just common health practices because there’s no like it’s it’s simply, um, very disrespectful to tell someone what to do like that and completely disregard, you know, everything that they assume works and might very well
Dr. Valerie Flaherman: [00:30:58] Work for them. It could be wrong. Yeah, yeah, yeah.
Lucia Arico-Muendel: [00:31:01] Yeah, yeah. So I feel like you’ve definitely touched upon that already, and it helps that you have you have people from the countries conducting the surveys a lot of the time.
Dr. Valerie Flaherman: [00:31:14] Yes, they do all the
Lucia Arico-Muendel: [00:31:16] All of them. Ok, so it doesn’t feel like an outsider often like entering the person’s home, right?
Dr. Valerie Flaherman: [00:31:24] Because they I mean, I’m conscious of that because that’s to me, that’s how it seems. But also, I know that within these countries themselves, there are a lot of various kinds of distinctions. And I don’t think that I can really assess very well, you know? What the relationship between all I can say is that when I see my team interacting with the moms, they they seem very respectful and the mothers also seem to feel empowered to say, Not now I’m busy, you know, I don’t want to do that or whatever, you know? And I don’t know. I do know, for example, that. There are there will be participants at our sites that may not speak even the main language of the. For example, in Guinea-Bissau, the kind of dominant language is a Portuguese Creole, so it’s like not quite Portuguese, but a Creole. But there will be participants that don’t speak that and they only speak like Dinka or like some other tribal language. And then in Kampala, most of the participants do. Almost all of them do speak to Ugandan, which is, you know, the kind of. And the dominant language. Ok. But but there will be participants that don’t. And so I don’t know the extent to which they are experienced, other people as outsiders or not, I don’t really know, but I think it’s certainly certainly there’s more cultural confidence between the team, the local team and the participants than between like me and the participants.
Lucia Arico-Muendel: [00:33:33] Right, right, right. Yeah, that makes a lot of sense. Ok, I guess now I would love to hear about your major takeaways. I know this is like a preliminary trial study. You’re planning on doing more, but what were your biggest conclusions? And then how like, how much do you feel that you can trust those conclusions? I guess, given like the flexibility of the trial, which is so great because like mothers are humans and they shouldn’t have to stick to something strict, but like, how well can you trust your results? I guess.
Dr. Valerie Flaherman: [00:34:16] So the results from the trial are blinded until we finished the trial. Oh, OK. So I actually don’t know the results from the trial. Ok, but the results from our early work, from the observational work that we were doing in 2019 and in 2020 before the pandemic, what we found is that babies, typically, as I was saying, they lose about seven percent of their birth weight after birth, typically reaching their lowest weight of their life at two days of age and then gaining. About thirty seven percent, you know, to top end up 30 percent above their birth rate on average. And we found the babies who start their weight gain later actually seem to gain less weight. So so that a delay in start like so everybody like 98 percent of babies initially lost weight. But then that part of where they start to, you know, to gain if they didn’t start to gain weight, that actually was, you know, where the risk happened. Okay. So and I do think that those I think those results were pretty consistent across a variety of populations. I don’t think they necessarily tell us, though, what to do with that information and to know what to do. We need trials, you know, so and to find out our trial results.
Lucia Arico-Muendel: [00:35:56] So I see. Ok. So how did you know which babies were more at risk? Like, are you still following that? Are you
Dr. Valerie Flaherman: [00:36:05] Still? We followed our babies through 30 days of age. Ok, but some of the babies really had not grown well at all at that phase. And in fact, I think there were several babies who actually weighed less at 30 days of age than they did at birth. So those are, you know, obviously real flags. So a kind of a not not good nutritional path. Hmm.
Lucia Arico-Muendel: [00:36:38] So in those cases, was there anything you could do to help or like they were just flagged and the medical teams in those countries were going to handle it?
Dr. Valerie Flaherman: [00:36:52] Yeah, exactly. And the idea for us was doing that observational work was to identify which populations were at the most risk so that then we could start to actually test which which interventions were most helpful because I don’t think we actually know one of the one of our team in Uganda had previously done a different trial where they randomly assigned residential areas to either having a peer counselor promoting exclusive breastfeeding or not. So like either you were getting an intensive promotion of exclusive breastfeeding or just nothing was really happening around that topic. And they found that the residential areas where exclusive breastfeeding was promoted actually had a lot more exclusive breastfeeding, but the babies actually grew slower. So. So that suggests that there’s something else that we need to try other than simply promoting exclusive breastfeeding. It may work well for some babies, but it doesn’t seem to work well for all babies.
Lucia Arico-Muendel: [00:38:12] Ok, so interesting. And do you see lots of opportunities to scale it up, or do you think you want to keep the study contained in the four countries it’s been in now?
Dr. Valerie Flaherman: [00:38:30] I think we need to see what our results are, and it’s kind of difficult to just be unsure and and, you know, and waiting. But I think, you know, when I go into it, when I go to do a trial, I want to have what we call equipoise, which is like where the I’m testing an intervention, but I really don’t know if it’s going to be helpful or not helpful. And I think this is for me. I feel like I have perfect, not perfect, but like I have very good equipoise about it because I’m really I’m not sure if this is going to be helpful. If I knew it was going to be helpful, it wouldn’t be ethical to randomly assigned babies not to get it right, but I really don’t know what will be most helpful. And and we won’t know actually, until we have our results.
Lucia Arico-Muendel: [00:39:24] Gotcha. Gotcha. And yeah, lastly, I’m just curious about how COVID affected data collection.
Dr. Valerie Flaherman: [00:39:34] Oh yes, yeah. But oh my goodness. So that was a major issue for our projects because, you know, as difficult as the shutdowns were in the. U.s., at least we had a lot of technology to keep us connected. Yeah. Are signs when the initial shutdowns occurred. Everything had to stop because, for example, the IRP applications had been all still paper based, so we couldn’t even get regulatory approval for months. There was no pathway to even get regulatory approval. Wow. And even when we were able to move forward with that, there were a lot of restrictions on movement in the country transportation, for example, just shortly after we started the trial in Uganda. Finally, a year and a half later, finally got the trial started in Uganda just days after the trial started enrolling. The lockdown occurred and they had almost all transit was banned for six weeks. Only cars with a certain kind of certification were allowed, and they banned motorcycles, which are a major method of getting around in Kampala. And in the past, for example, our nurses had taken what like they call the boda boda and it’s like a taxi, but it’s a motorcycle and you ride on it, right? So that they would get around that way. And those were like, strictly forbidden. Oh my God. So there they had to find a car.
Dr. Valerie Flaherman: [00:41:27] And of course, the car was extremely costly. At at my sites, many people like not all the staff can drop. Most people can’t drive. So then you often have to hire an additional driver. Plus, the car gasoline is very expensive and then you have to go to the houses and people don’t necessarily want anybody in their house. And similarly, the hospitals don’t necessarily want other people in the hospitals. So a very difficult situation. And at the at the same time, just necessary to prevent spread of COVID. So it’s not, you know, there was not really an alternative, right? But but just really, really difficult. So at this time, both of our countries have had most of the restrictions lifted at this point. Ok. So it’s a lot easier to get around and the boda boda are back in Kampala, so that’s like a sign of return to normal. But just a really challenging situation. And I think, you know, I’m really proud of our teams for, you know, all their careful coverage hygiene, you know, everybody learning to wear masks, these hand sanitizer, you know, all the things that people do to be careful. But when you know, when transportation is prohibited, it’s really out of our hands and there’s really nothing we
Lucia Arico-Muendel: [00:43:05] Can do, right? Yeah, but you didn’t have any participants in the trial with COVID or,
Dr. Valerie Flaherman: [00:43:18] You know, I think I actually am not supposed to talk about specific participants yet, but they so fine talking about that. Yeah.
Lucia Arico-Muendel: [00:43:28] Next episode?
Dr. Valerie Flaherman: [00:43:30] Yeah. Yeah.
Lucia Arico-Muendel: [00:43:33] Wow. All right. That sounds very challenging. I didn’t even think about transportation, how that would affect everything.
Dr. Valerie Flaherman: [00:43:42] It was, yeah, it turned out to be key. And like everything else with like the lockdown, you take it for granted. Like you’re like, Oh, like cars, buses, you know, motorcycles like you don’t think of those as being related to a respiratory disease, you know, but then with the lockdowns occur, you know, suddenly they’re just prohibited, right?
Lucia Arico-Muendel: [00:44:05] So, yeah, yeah, right. And it’s like, when do you take a step back from researching other very important global health topics because there’s just a major, major pandemic, right?
Dr. Valerie Flaherman: [00:44:18] A lot of people did that. A lot. A lot of people did that. Yes, yes, not our group. It didn’t end up we actually thought about that and pursued it a little bit in the beginning, but it wasn’t right. It wasn’t a good fit for for our teams or what they were doing. I see.
Lucia Arico-Muendel: [00:44:39] I mean, your work is so interesting to me. Thank you so much. Oh, thank you for taking the time to talk about it. I’m I’m sure that everyone will be really. Are they interested in this? Yeah. And yeah, I think that.