Ep. 4: 100% Human Milk Diet—Perspectives from Dr. Martin Lee

Dr. Martin Lee

Dr. Martin Lee. Photo courtesy of Prolacta Bioscience.

Episode 4 features Dr. Martin Lee, Vice President of Clinical Research and Development at Prolacta Bioscience. During this episode, Dr. Lee provides a comprehensive overview of a 100% or exclusive human milk diet in the prevention of NEC in extremely premature babies, those weighing less than 1250 grams (2 pounds 12 ounces) and who have the greatest risk for developing the disease. He discusses:

* His transition from the blood industry to Prolacta, which developed of the world’s first human milk-based human milk fortifier

* What constitutes a 100% or exclusive human milk diet

* The clinical evidence showing a 70% reduction in NEC, an 8-fold reduction in surgical NEC, and a 4-fold reduction in mortality through the use of exclusive human milk diet

* The importance of safety in the breast milk industry, including Prolacta’s rigorous product testing and donor safety profiles which parallel blood industry standards.

Copyright © 2015 The Morgan Leary Vaughan Fund, Inc. This episode was produced in part by the TeacherCast Educational Broadcasting Network.

STEPHANIE VAUGHAN, HOST: Welcome to Episode 4 of Speaking of NEC—a free, audio podcast series about Necrotizing Enterocolitis.

Produced by The Morgan Leary Vaughan Fund, and funded by The Petit Family Foundation, Speaking of NEC is a series of one-on-one conversations with relevant NEC experts—neonatologists, clinicians and researchers—that highlights current prevention, diagnosis, and treatment strategies for NEC, and the search for a cure.

For more information about this podcast series or The Morgan Leary Vaughan Fund, visit our website at morgansfund.org.

Hello, my name is Stephanie Vaughan. Welcome to the show. I’m the Co-founder and President of The Morgan Leary Vaughan Fund.

Today, my guest will be Dr. Martin Lee, Vice President of Clinical Research and Development at Prolacta Bioscience, which “creates specialty formulations made from human milk for the nutritional needs of premature infants in neonatal intensive care units.”

Last October (2014), while attending the annual Preemie Parent Summit in Phoenix, Arizona, I had the pleasure of meeting Prolacta’s Chief Executive Officer Scott Elster. During our conversation, I was invited on a tour of the company.

A few weeks later, along with a group of representatives from various preemie organizations throughout the country, I flew out California to tour Prolacta’s human milk processing facility, and to learn more about the people and research behind the company.

I was highly impressed by all aspects of Prolacta from the manufacturing plant itself to the rigorous testing their products undergo throughout their processing. Even more impressive to me is the fact that everyone that we met at Prolacta has a personal connection to prematurity. The CEO himself is the parent of twins born prematurely.

And, I was shocked to learn that one of the key reasons the company was formed, and their products developed, was to reduce the incidence Necrotizing Enterocolitis. The company’s reason for existing is the prevention of NEC.

And the research presented to us by Dr. Lee was stunning. So when we began producing this series, it was only fitting to invite Dr. Lee to share the benefits of an exclusive human milk diet to premature infants and the clinical research supporting its use.

With that in mind, let me introduce my guest today.

This is Dr. Martin Lee from Prolacta Bioscience. And I’m so glad you could be with me here today. How are you?

MARTIN LEE, GUEST: Good. How are you doing Stephanie?

STEPHANIE: Good, good. So in previous podcasts, we’ve talked to doctors that are attending neonatologists and researchers. So I would like to give you the opportunity to give a little bit of your background and how you got involved with research in NEC.

DR. LEE: OK. Absolutely. Well, I spent probably most of my career doing clinical research with various types of pharmaceutical and biotech products. I started with a company you’ve probably heard of called Baxter approximately 35 years ago, and I spent a good number of years working with them. And how that’s relevant to our discussion today is I was working with their group that manufactures blood products, and obviously blood is a significant human fluid, has many of the same issues with regards to safety that we have with breast milk. And so I learned a lot about some of the testing that needs to be done, some of the safety factors that we need to consider. And then I would say about 15 years ago, I met someone who was talking about forming a company who basically wanted to bring breast milk and breast milk products to premature infants so that they would have the benefit of receiving 100% human milk diet, particularly the smallest of the small premature infants. So together we started the company Prolacta. And the whole idea of course in starting the company was to put it‚…I think the most important thing was to put it on a firm clinical scientific basis. And that meant doing really important well-designed clinical trials to evaluate the most important morbidities like NEC, in particular, and even mortality in premature infants, infants certainly that had a high risk of both of those consequences of prematurity.

STEPHANIE: OK. Maybe not all of the people that will be listening fully understand…what is an exclusively human milk-based diet? Can you get into that a little bit?

DR. LEE: Absolutely. So obviously we know‚…we meaning pretty much the world understands that the best thing a newborn baby can be fed is mother’s milk. And for term babies, that is obviously going to be sufficient. They’re born at the right time and usually at a sufficient weight and mother’s milk has all the good things in it that help the baby to grow, help their immune system to develop, help their organs to develop, importantly it helps their brain to grow at the right rate. But a premature baby by definition is born too soon. And we specialize‚…the work that we’ve done at Prolacta,…specializes in the infants that are born as much as 27 weeks or 12 weeks premature so 27 weeks since the time of gestation. When those babies are born, they have a lot of problems obviously because they’ve come out of the womb way too early. And one of the things that of course they are is way too small. The average baby that we’ve studied in our research trials is less than a thousand grams. That’s around two pounds. Now most people know that the average baby is 6-7-8 pounds. And so they’re born so small that what happens is that mother’s milk which of course comes in when the baby’s born‚…nature didn’t intend mother’s milk to be able to feed these type of babies. This is an unfortunate consequence of something that happened with the mother, something that‚…injury, genetics, whatever it is that would cause a baby to be born premature, the milk comes in, but it cannot feed that baby well enough. And what I mean by that is the baby needs to grow. He needs to grow a lot. The baby needs to have their immune system protected by the mom’s milk, and so on and so forth. So obviously we always talk about mother’s milk being the thing for a newborn baby. It’s not enough for these premature infants. So what they need is what we call a fortifier, something with a little extra kick to the baby. And there are fortifiers that have been on the market for a long time. They’re made by the formula companies. And naturally these fortifiers are made from cow’s milk. And cow’s milk is not the best thing for a premature infant. It may not be the best thing for babies in general, but besides the point, it’s certainly not the best thing for a premature infant. So when we’re talking about 100% or exclusive human milk diet, we’re talking about mom’s milk; we’re talking about a fortifier which is necessary for the baby to grow and to be protected from infection and so on and so forth. That comes from human milk. And what Prolacta did was develop the world’s first human-milk human milk fortifier. And in fact, it sounds like a mouthful because when we talk about human milk fortifier, general people realize or may not realize that that’s a cow’s milk-based fortifier. We make the one from human milk. So that’s what we mean by 100% diet. And then one other thing just to add to that, Stephanie, is sometimes mom’s milk doesn’t come in enough or the baby wants it or needs to eat more, get more milk, so then there’s donor milk involved too. And that’s another aspect of the 100% diet. And of course donor milk is coming from other moms, which again provides the additional nutrition that the baby needs. And there you have the entire spectrum of what we mean by 100% human milk diet.

STEPHANIE: OK. Thank you. Yeah, I know that there’s probably a bit of confusion amongst parents new to the NICU that human milk fortifier is a fortifier put into human milk, and not necessarily made with human milk. So I know that that does tend to cause a little confusion.

DR. LEE: Right.

STEPHANIE: So thank you for clarifying that.

DR. LEE: Sure.

STEPHANIE: So I guess I’ll ask you to go into a little bit of the research because I find it fascinating. As you know, we were out to your facility in November and I thought that this is a fabulous company. I was not aware of it when our babies were in the NICU and I will just make a tiny note that I know you’ve got significant statistics showing the benefit of human milk and exclusive human milk. Unfortunately for Morgan, he fell in to that other small percentage that I did pump. But he developed NEC so rapidly at four days old being born at 28 weeks. At four days old he developed NEC and I don’t think he had two feedings. So there are babies that get it even when all attempts are made to have an exclusive human milk diet.

DR. LEE: Sure.

STEPHANIE: And I also know that my other son, Shaymus, his milk was fortified, and to be honest, I’m sure it probably wasn’t with an exclusive human milk fortifier. So just some things to sort of give everyone background. And again, that was, you know, four years ago, 2010-2011.

DR. LEE: Sure. I hope…I assume they’re doing OK today, right?

STEPHANIE: Yes, yes. Everybody’s doing very well today…

DR. LEE: Excellent. Excellent.

STEPHANIE: which I think is why I’m so personally‚…my personal opinion is that your products are wonderful and, you know, things being what they were then versus now, I would definitely advocate for 100% human milk diet and advocate for this if I was a parent in the NICU now. So I think it’s great to get this information out to people.

DR. LEE: Sure. Absolutely. So your question concerned the type of studies we did. Well, as I said to begin our conversation, we recognized that the only way that people‚…the medical community, both neonatologists, nurses, lactation people‚…would appreciate and realize the importance of what 100% human milk diet does and helps as far as the baby is concerned is to do proper research. As I said earlier, my experience is in the pharmaceutical and biotech industries where doing formal randomized controlled all the kinds of bells and whistles that need to be done when you need to license a drug or a biologic for marketing in this country and other places in the world as well. That’s standard stuff. So when we set out to do these studies, we said what we’re doing here is just as important, just as the need for rigor has to be here as it would be in any other kind of situation where you’re testing a new medical intervention. And that’s what this is. So we decided right off the bat we would get together the best of the best as far as the neonatologists in this country are concerned, and we brought them together and we set up a protocol. And basically the protocol was based on a very simple premise. It is 100% human milk diet better than feeding a baby mom’s milk fortifying then with standard human milk fortifier and then if all else fails or at least maybe not be sufficient than using formula. That’s standard practice for premature infants in this country. It was in 2007 when we started this trial and to a large extent it still is today. So it’s 100% human milk diet standard of care which includes cow’s milk based fortifier and formula. Babies in this study were randomized which is‚…you know, it’s a fairly simple term, but just to make sure everybody understands what I mean by that, the decision when a parent agreed to have their baby be participating in the study which group they get into, the Prolacta or the 100% diet versus standard of care was essentially a coin flip, not literally of course, but that’s the basis. Now why do you do that? Because that’s the best way to design studies. It provides an unbiased approach to making the decision of treatment of nutritional treatment, taking it out of the hands of anybody and putting it in the hands of strictly chance. So you randomize babies. There was a sufficient number of babies in the first study we did. There was over 200 babies that were randomized and I think it was 12 centers around the country. And what we were looking for in this study was whether or not they develop NEC and that was the most significant endpoint of the study. There were other things that we looked at. We looked at how much parenteral nutrition they received. We looked at other things. We looked at sepsis. We looked at‚…which is essentially bacterial infection that circulates in the bloodstream. We looked at hospital days. We looked at days on a respirator/ventilator and so on and so forth. But the main endpoint in this study was Necrotizing Enterocolitis. Now, the babies, by the way, that we used in this study or the babies that constituted the population of the study were babies under 1250 grams (2 pounds 12 ounces) down to 500 grams (1 pound 1 ounce). Very simple reason for that. I think many of the people listening will know that there’s a classification of premature infancy called very low birth weight. And that’s babies under 1500 grams (3 pounds 4.91 ounces). But we said, you know, we want to get the babies that have the highest risk of NEC. So we didn’t use, if you will, the heaviest babies in that weight category because they have, it turns out, the lowest risk of NEC out of all very low birth weight babies. So we took away that 1250-gram group. We also didn’t go below 500 grams because unfortunately, babies born less than 500 grams which is really about a pound or less have unfortunately not a high chance of either succeeding in life really and survival or they have a lot of other problems that make it very difficult to evaluate then. So it was 500 to 1250. That’s basically, I think, the most important aspect. And like I said, they were randomized. We followed them for a period of 90 days, maximum 90 days. Babies could have gotten off the study earlier if they got on to mostly oral nutrition which of course hopefully babies all do because they start off with what’s called parenteral nutrition which means they get their feed essentially through intravenous feeding. They then transition off of that onto enteral feeding which is typically a tube that goes either through their nose or directly through their mouth into their stomach. And that’s called enteral feeding. And then they go to oral feeding. So babies who are on for 90 days or if they got to oral feeding sooner, then they were off the study. Very simply, just to summarize what constitutes a fairly complex study to manage, we found a magnificent reduction in Necrotizing Enterocolitis. The babies in the standard of care group had a NEC rate of about 16%. Or put simply, that one in every six babies develop NEC that got some sort of cow’s milk protein or cow’s milk diet. The babies who got 100% diet was less than 6%. That 16 to 6 is about 70% reduction, and that is phenomenal. We’ve had some of the really very famous neonatologists told us that they don’t see‚…you don’t see that kind of reduction with really any intervention that they’re used to seeing. You just don’t see that. You see incremental things. But now all of a sudden we cut NEC by 70% by doing this. And it even gets more impressive when you consider that the majority of babies or at least half the babies who develop NEC have to go on to have surgery.

STEPHANIE: Right.

DR. LEE: And that is a really serious consequence not only just from the fact that a premature infant has to go on to major surgery and they take out part of their digestive tract. But even worse, they have a reasonably high mortality rate. So in this study, the rate of NEC surgery of all those babies that were in the two groups, it was at 11% in the standard of care arm and only just over 1% in the Prolacta arm. We reduced the rate of NEC surgery by eight fold, I mean just an incredible difference. Virtually wiped out NEC surgery in this study.

STEPHANIE: That’s amazing.

DR. LEE: Yeah. I mean, we expected to see something really good. We didn’t expect‚…I guess you could say well we should have expected‚…but it was beyond our expectations, wildest dreams to show this kind of effect. Now a lot of people have looked at this data and said well that’s interesting, and maybe that’s real. But can you‚…you know, can you do it again? And the answer is yeah. We did it again because that first study that I just described, these were only babies who were getting‚… which are most babies‚… who were getting some breast milk from their mom. But there are a small cohort of‚…

I don’t know quite what the percentage is in this country, but there’s a percentage of babies who don’t get any breast milk. There’s various reasons. Mom is sick. Mom’s not available. So on and so forth. So we also did a second study in which we only treated babies or fed babies who had to get their nutrition either one of two ways. Since breast milk wasn’t available, they got formula. Soon as they were able to get enteral feeding, in other words the tube feeding, they got formula. That’s one group. The 100% arm, same thing, except here, instead of getting mom’s milk, they got donor milk, and then they got the fortified. So it was a real stark comparison. Only human milk, only formula. And it was a very small study. It was only‚…that first study, I don’t know if I mentioned or made clear, that was a 200-baby study. Pretty big study.

STEPHANIE: Yes. Um-hmm.

DR LEE: This study was only 53 babies partly because it was very, very hard to find these babies. I mean, we would sign up a mom, they would agree to put their baby on, and then they realized gee, I really want to feed my baby. I really want to give them breast milk. And of course, that’s fine. That’s great.

STEPHANIE: Right, right.

DR LEE: But they can’t participate in the study.

STEPHANIE: Right.

DR LEE: So we had a hard time finding. But we eventually did it. Took us three years to find 53 babies, but we did, and you know what? We found the same significant difference, particularly in the surgical NEC. There were‚…in the control arm, there were 24 babies, and four of them had to go on to surgery for NEC. That’s one in six. So about 16%. In the Prolacta arm, in the 100% milk arm, nothing, no surgeries, nothing. One case in NEC overall, but no surgery. So that turned out to be wow. That’s the kicker. Two separate studies, two different classes of babies, breast milk, no breast milk, doesn’t matter. When you give a baby that’s born premature like this, this weight category, less than 1250 grams, and you feed them with only human milk, they’re going to do better. And it even turns out when you start putting all the data together an extra‚…I hate to call it a bonus‚…but an extra important key outcome was that mortality was reduced. Mortality fortunately in this baby population is pretty low. It’s about 8% overall because of the prematurity, of course. We reduced that to 2%. So a four-fold reduction in mortality. So now when you put it all together, what do you have? You have prevention of the major morbidity‚…that is NEC‚…of prematurity, and you prevent mortality. And how can you really ask for anything more from a nutritional approach to these really fragile infants.

STEPHANIE: Right. Right. No, I totally agree. And as I said before, my personal opinion, you know, as the mother of a surgical NEC survivor, I would advocate for this if we had to do it again. It’s definitely phenomenal.

DR. LEE: Yeah, it’s almost this kind of effect you would expect to see if this was a pharmaceutical breakthrough or some new wonder drug or some sort of biotechnologically-produced intervention. But all it is is feeding the babies properly. I mean it’s such a fundamentally sound, logical‚…this is what nature wanted these babies to get.

STEPHANIE: Right, right.

DR. LEE: Babies should get human milk, nothing else.

STEPHANIE: Now you had mentioned previously the difference between donor milk and then your human milk nutritional products. Can you‚…when I hear conversations, I sort of always think it’s like comparing apples and oranges. You know, it’s almost two different things. So can you clarify what the difference is with donor milk and your products?

DR. LEE: Well, again, I’m sorry to be maybe not entirely clear. We make a donor milk product. Essentially, all our products are made from donor milk, both the fortifier, of course, and we make a simple donor milk product that is formulated to have 20 calories per ounce which is what doctors and nurses and dieticians believe they’re giving the baby when they feed the baby either mom’s milk or milk from another person. So donor milk is essentially the equivalent of mom’s milk other than the fact, of course, it comes from another mom. But however‚…and in fact, the American Academy of Pediatrics has said the best thing for a baby is mom’s milk. But if mom’s milk is not available, then donor milk is good.

STEPHANIE: Right.

DR. LEE: But the problem, of course, and one of the I guess you could say‚…I’m trying to think of the right word. Bad things that people associate with donor milk is well it comes from somebody else, and how do I know that person is the right person to provide milk for my baby? And that’s one of the key things that we had at the center of what we did at Prolacta from the beginning, which was to have a safety profile that was beyond reproach. I mean, we do things as far as testing the moms, testing the milk, that nobody else who ever handles breast milk does pure and simple. I’ll give you some examples. One of the things that I thought of very early on is because, again, remember I told you I came from the blood industry and they test blood and they test donors obviously every which way you can think of. But there’s one additional problem that donors who provide milk have in a sense that blood donors don’t. When you take blood from a donor, you’re seeing the person and it’s blood coming out of their vein and it’s coming right into a bag and you know whose it is. But a milk donor, she donates at home, pumps at home, puts it into containers, and then sends it wherever the donor, the milk bank, might be. In our case, it’s here at Prolacta. They’ll send it to us, and here’s the problem. How do we know it’s that person’s milk?

STEPHANIE: Right.

DR. LEE: How do we know it’s the person who we screened and did all the blood testing on to start with, that it’s her milk. So we do something very, very unique. We actually have the mom provide a DNA sample, they do a little cheek swab, they put a little stick essentially in there, and scrape off a little tissue from inside their cheek, send it to us so we have a profile. Now she sends us her milk, and when she sends us her milk, we can actually match it up. And now we know it’s that safe mom’s milk, all right? Now you might ask what’s the point? I mean what self-respecting individual is going to send somebody else’s milk to you? And the answer is nobody, for the most part I can say almost universally, will do that intentionally. But there are mistakes. I mean one of the things we’ve seen is moms that are lactating, sometimes there’s a couple of women in a neighborhood, and they’re all doing the same thing. And somebody’s freezer will become full with milk, and they’ll say to their neighbor, “Can I put my milk in your freezer?” And they said, “Sure, no problem.” And she’s got her own milk in there. And then they go to ship milk and lo and behold, there’s somebody else’s in there. We love that‚…we love the moms, but we have to be sure that every mom that donates is a mom that’s free of all of the nasty things that could be in blood because those things could be in milk as well like AIDS and hepatitis and syphilis and all those kinds of things that we should be concerned about. Even as an adult you certainly want to get blood from someone like that. You certainly don’t want to give that to this fragile premature infant.

STEPHANIE: Right, right.

DR. LEE: So going back to your original question about what we do versus donor milk, that’s all one in the same, I think you could safely say. Everything is based on the concept of donors and the milk that they provide and the safety of that milk supply being tested from any way you can think of so that every product that’s made from human milk is as safe as possible based on all of the different protocols that are used. And that includes other things besides DNA testing. It includes drug testing; it includes testing for whether the mom smokes because they may tell you they don’t smoke, but we’ve seen that instance where there’s byproducts of nicotine in the milk, and that’s not good for a baby. So we do that kind of testing. It’s just a laundry list of things to make that as safe as possible.

STEPHANIE: Right. And I guess‚…I’m sorry‚…I guess to clarify my original question, I was speaking specifically about your fortifiers versus human milk. If you could explain a little bit the difference of that‚…I mean this was a very good‚…I can’t think of the word‚…a very good deviation, but yeah. When I was saying apples and oranges, I meant donor milk versus fortifier.

DR. LEE: OK. I’m sorry.

STEPHANIE: No, that’s OK.

DR. LEE: The fortifier essentially‚…if you want to keep it very simple, the fortifier is just very concentrated milk.

STEPHANIE: OK.

DR. LEE: So essentially, what you do to make the fortifier is you take milk, you filter it to get rid of a lot of the fluid so that you concentrate the protein, you concentrate some of the other important nutrients in there. And that way the baby can get extra, like we say, protein, extra other nutrients in a very, very small volume. So for example, in our typical fortifier which we call Prolact +4, if you add that to mother’s milk in a ratio 80% mother’s milk to 20% fortifier, assuming mother’s milk is about 20 calories per ounce, you’re going to add 4 additional calories for that baby in that small volume which is a lot. So then we can actually do even more than that. We can do a +6, six calories, we can do +8 and even +10. That kind of product is for the babies that are the most fluid restricted. They can get 30 calories per ounce in the same volume that milk that originally was 20 calories per ounce was. So that’s really important for those babies, for example, that have heart defects who can’t take in a lot of fluid or babies for whatever reason are fluid restricted.

STEPHANIE: OK. Thank you.

DR. LEE: Sure.

STEPHANIE: Yeah, that was‚… I think it’s important for parents and family members that might be in the NICU to be able to have a conversation with their doctor and fully understand what’s being given to their baby and be able to ask the right questions. So would there be anything else that you would want to add if you were talking to a parent who’s got a baby in the NICU right now for them to be able to advocate best practices for their baby?

DR. LEE: I think that the simple issue for a parent under these circumstances is to ask the doctor based on all of the evidence that’s out there, clinical evidence,…and that’s how doctors make decisions. We talk about evidence-based medicine. This is based on the best evidence that the doctor is aware of, what’s the best way to feed my baby? And having said that, you know, the evidence that we’ve discussed here today is for those smallest of the small. For a larger baby, this is not necessarily‚…it’s not that it’s wrong. It may not be necessary, but when you’re dealing with the smallest babies and the ones that are struggling to survive and grow and thrive and get to where you want all babies to get to, to childhood and so on, then you have to ask the doctor the question what is the best way that our baby can get out of that NICU, that Neonatal Intensive Care Unit, and get home and be with his or her parents. That’s really, I think, the fundamental question. And the doctors should be able to answer that question based on the evidence that exists for the diet that the baby should be fed.

STEPHANIE: Right. Thank you. Yeah, I think this is a really great conversation for any parent in the NICU, especially those, like you said, the smallest that are at the highest risk for developing NEC and as you said, other issues as well. And it’s‚…it can only be a benefit in my opinion.

DR. LEE: Absolutely. And just to add to that, they should also ask the question‚…because there are other sources of nutrition, and there are other places from which milk can be attained we know about, for instance, women sharing milk on the Internet, milk sharing sites. You’ve got to be extremely careful. You’ve got to ask the question not only what’s best for my baby from the point of view of effectiveness, but also what’s the safest for my baby. And you want to be sure that the source, where that milk is coming from, where those products are coming from, comes from a place where you can say everything possible based on modern technology has been done to protect that milk, protect the safety of that milk. And I think that’s really critical. I think there was a story the other day‚…I forget which show, where it came up in one newspaper or another‚…about‚…oh, I know what it was. It was an article that was published that basically looked at milk samples. They actually collected milk on one of these sharing sites, and they found a large percentage of them had nicotine in the milk, had other things, other bad things that you don’t want a baby to have in that milk. So you’ve really got to ask that question what’s the best? What’s the safest for my baby as well?

STEPHANIE: Right. Right. And Prolacta has provided us some material, some reference materials for sharing. So I will say that we’re going to be posting those on our website and will have them in the show notes as well. And I really appreciate you taking the time to talk to me today. If there’s anything else at all that you would like to add, please feel free.

DR. LEE: Well, I just want to thank you for the opportunity to let obviously the parents out there know that we’re here for one very, very simple reason. I mean I know it may sound kind of corny, but we said from the day we opened the doors at Prolacta that we’re here to save babies, and I think we’ve done our job in that regard. And we’ve proven that that’s the case. So I’m really‚…I’ve worked, as you heard me say, for 35 years doing clinical and medical research, and I’m very, very proud to say that this is, I think, my best story to tell out of all that long career.

STEPHANIE: Right. And as I said, I was out in the facility, took the tour in November, and we were very impressed with your company. And like I said, if I had to do it all over again, I would certainly be asking these questions and in my opinion, I think this is a phenomenal company. And your rigor in testing and your facility are top notch. So thank you.

LEE: Well, thank you. Thank you. I really appreciate that, and it means an awful lot to me and to obviously everybody that works at Prolacta.

STEPHANIE: Right. So thank you for joining us. And hopefully we’ll talk again soon.

LEE: Alright. Thanks so much, Steph.

STEPHANIE: In closing, I’d like to share a few thoughts about today’s conversation with Dr. Lee.

Recently, I’ve seen a lot written about the use of donor milk, human milk products, and the emerging breast milk industry. Often times, the opinions expressed about Prolacta are solely related to cost: the expensive of Prolacta’s products versus those coming from nonprofit donor milk banks.

In my opinion, the cost of using Prolacta’s human milk-based human milk fortifier far outweighs the potential risks of not using it, and any discussion about cost needs to be framed within the context of total cost of care.

As Dr. Lee mentioned, Prolacta’s human milk-based nutritional products are intended for extremely premature infants who weigh less than 1250 grams (2 pounds 12 ounces) at birth. My son Morgan weighed 2 pounds 5.5 ounces at birth; my son Shaymus weighed 2 pounds 7 ounces.

Prolacta openly shares that the typical cost of using their human milk-based human milk fortifier for these babies is $10,000. That, however, is only a fraction of Morgan’s and Shaymus’ total cost of care. Each of whose exceeded $1 million.

In actual numbers, the cost of an exclusive human milk diet using Prolacta’s human milk-based human milk fortifier would have been less than one percent of Morgan’s total cost of care, and less than one percent of Shaymus’ total cost of care.

And while Morgan’s case shows that no current preventative strategy for NEC is 100% effective, research shows that access to, and the use of, an exclusive human milk diet significantly reduces the risk of NEC in the majority of extremely premature infants.

Show your support for our smallest and most fragile babies, those who have the greatest risk for developing NEC. Show your support for continued research in NEC. And join our effort to raise awareness about, and funds for research in NEC by making a donation to Morgan’s Fund at morgansfund.org.

If you’ve had a personal experience with NEC and would like to share your story, or have a question or topic that you’d like to hear addressed on our show, e-mail us at feedback@morgansfund.org. We’d love to hear from you!

Additional resources:

Prolacta Bioscience, Inc. What Is Necrotizing Enterocolitis? N.p.: Prolacta Bioscience, 2015. Print.

Prolacta Bioscience, Inc. 100% Human Milk: The Best Nutrition. N.p.: Prolacta Bioscience, 2014. Print.

Prolacta Bioscience, Inc. Nutrition for Premature Babies. N.p.: Prolacta Bioscience, 2014. Print.

Prolacta Bioscience. Premature Babies: What to Expect. N.p.: Prolacta Bioscience, 2014. Print.

Copyright © 2015 The Morgan Leary Vaughan Fund, Inc.

The opinions expressed in Speaking of NEC: Necrotizing Enterocolitis (the Podcast series) and by The Morgan Leary Vaughan Fund are published for educational and informational purposes only, and are not intended as a diagnosis, treatment or as a substitute for professional medical advice, diagnosis and treatment. Please consult a local physician or other health care professional for your specific health care and/or medical needs or concerns.

The Podcast series does not endorse or recommend any commercial products, medical treatments, pharmaceuticals, brand names, processes, or services, or the use of any trade, firm, or corporation name is for the information and education of the viewing public, and the mention of any of the above on the Site does not constitute an endorsement, recommendation, or favoring by The Morgan Leary Vaughan Fund.

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