#456 - [Neo News] - 📌 Why Did the US Fund a Hepatitis B Trial That Withheld the Birth Dose?

In this episode of Neo News, Ben and Eli break down a troubling story in vaccine policy: an unsolicited $1.6 million CDC grant funding a Danish research group's trial in Guinea-Bissau, one designed to withhold or delay the hepatitis B birth dose from thousands of newborns in a country where the disease is highly endemic. They trace the ethical parallels to Tuskegee, the funding irregularities, and the pushback from the Africa CDC that halted the study. They also cover the clinical stakes clinicians face daily, including age-dependent chronicity and the real risks of a "safe" two-month delay. A candid, unfiltered conversation about advocating for evidence-based care when the evidence itself becomes politicized.

Transcript

Eli Cahan (00:02.086)

Hello everybody, welcome back to Neo News. This is our segment devoted to promoting the doctor-patient relationship by keeping you up to date with what's buzzing in the news today. We're going to keep moving — our next set of articles is about something we're very passionate about and keeping a close eye on here on the news, which is... hepatitis B, not vitamin K. We just talked about vitamin K, hepatitis B — we're passionate about both, but anyway, Freudian slip on that one. Hepatitis B. I think we've talked previously on Neo News about decisions made behind the curtain at federal agencies, and other agencies, that shape the evolving conversation around prenatal, perinatal, and postnatal care in this country. When you think about the conversations that are happening around hepatitis B — we've discussed previously the rhetoric from the government saying that people diagnosed with hepatitis B, known cases of hepatitis B, their infants should get the vaccine, because we know that many, many people in the US who have hepatitis B are not diagnosed. So that's one thing we've talked about in the past — the government's discussion that this should be shared decision making, as if that's not something we were already doing, and whether that introduces new layers into these conversations, as well as doubt in the advice or recommendations of health institutions. Another piece of this conversation, around how the conversation is shifting, is what direction the science is going in around these sorts of vaccines, and what the government is paying for, what they're supporting in terms of the science they're interested in, and the evidence base they're interested in developing. We've spoken previously about the government's initiatives to study more in depth the relationship between vaccines and autism, to much controversy and uproar from various agencies and associations like the AAP (American Academy of Pediatrics), which we won't get into. One of the efforts the government has taken, as it relates to hepatitis B, is the funding — unsolicited, non-competitive funding — of two Danish vaccine researchers, much-maligned Danish vaccine researchers who, and I quote, are best known for pioneering a theory that vaccine opponents have embraced: that vaccines have potentially unknown and nonspecific effects on the immune system. And that while some vaccines that use weakened live viruses can reduce mortality, others using inactivated viruses can increase it. My dear colleague, friend, and mentor, Katherine Eban, wrote about these two researchers for Rolling Stone — she basically used a research outpost in an impoverished West African country, Guinea-Bissau, to look into the relationship between hepatitis B vaccines and all of these outcomes. At one point, Katherine found these two researchers and their project were at a point where they might not be able to continue the research — until they got a financial lifeline at the top level of the US government's scientific establishment, in the form of a $1.6 million grant to fund global health research into the dangers of vaccines. That's the conversation around what the government is paying for — what kind of science, what kind of global health work — when it feels like they won't pay for other forms of global health work. But when it comes to funding a vaccine study in Guinea-Bissau, this is, quote, "a funding priority for CDC (Centers for Disease Control and Prevention) slash HHS (Department of Health and Human Services)," according to a senior advisor at the CDC, and on the heels of these kinds of decisions, there's now emerging data that the doubts and rhetoric around hepatitis B are showing consequences. There's a study that came out in JAMA (Journal of the American Medical Association) Network that found vaccine rates for hepatitis B rose from 67% in January 2017 to a peak of 83% in February 2023, and then declined to 73.2% by August 2025. There's another analysis showing pretty profound economic consequences to a lack of vaccination. So even if you thought, well, this is my decision, and the decision just for my infant doesn't have bearing on anyone else — and by the way, it doesn't really have bearing only on our family — this study, in an analysis of 3.6 million infants, found that delayed vaccination scenarios — these are cases where the infants did get vaccinated eventually, just later — added costs on the order of tens of millions of dollars, due to additional infections in infants who delayed vaccination. So Ben, what do you make of the government's decisions around the science they're paying for, and the consequences of those decisions, as we're seeing there, in the clinical as well as the economic data?

Ben Courchia (05:57.935)

I want to go back to this situation you brought up about the study in Guinea-Bissau, because if you haven't heard about this, it's a case study in medical research ethics. Basically, what you have to understand is that the trial over there was designed to evaluate, quote unquote, the "non-specific effects" of the newborn monovalent hepatitis B vaccine. And the trial was designed by this Danish group, the Bandim Health Project. Listen to this — this is where it gets really... I'm sorry, I'm going to curse, but it gets really fucked up. Their core hypothesis basically states that some vaccines can have broader, non-specific changes to an infant's immune system, potentially increasing all-cause mortality, or contributing to neurodevelopmental and skin conditions. So basically, it's a unique study where they're searching for harm. And unlike other trials, where you'd use a vaccine to try to reduce spread or establish efficacy against a specific pathogen, this study is explicitly structured to hunt for hidden negative side effects of a 40-year-old vaccine that global health bodies long ago established as safe. So how do they go about doing that? They go to Guinea-Bissau, where they're trying to enroll 14,000 newborns. This is an impoverished country in West Africa where the background rate of hepatitis B is exceptionally high — extremely rampant within the population. And the protocol set up a single-blind randomized controlled trial where half of the enrolled infants would have the standard hepatitis B birth dose intentionally withheld or delayed for weeks to serve as the control group. I'm just going to let that sit for a second — this is infuriating. The articles you mentioned highlight emails that leaked between the CDC and these researchers, where the CDC in the US was interested in potentially funding this particular work, because if they could highlight some negative effects associated with the hepatitis B vaccine, it would go along with the desire to change the current practice of giving the hepatitis B vaccine at birth. Now, thankfully, the official halt of this study in Guinea-Bissau came after strong warnings — from whom? From the Africa Centers for Disease Control and Prevention, the Africa CDC. Thankfully, the medical community and public health researchers have all been up in arms about this. Some members of the US Congress thankfully also raised vehement opposition, and the study is no longer taking place. It's not just that you can argue about a study and say "I don't like how this is done" — I think it's important to go over the details: we're talking about taking 14,000 babies in a country that's rampant with hepatitis B, and withholding the vaccine. It's absolutely insane, and it makes me furious. That's number one. And then I think the—

Eli Cahan (09:32.07)

Ben, before you go any further — do you know what people would say about this study if it were happening in Alabama? You know what they'd say if this same study were happening in Alabama? I think they'd say one word.

Ben Courchia (09:45.399)

Yeah. They'd say... yeah, I mean, I think you're talking about the R word.

Eli Cahan (09:52.812)

No, I'm talking about the T word — Tuskegee. If we were saying, "hey, let's randomize thousands of people against the thing we know works, and just kind of see how it plays out" — I think,

Ben Courchia (10:10.975)

It's worse than that, Eli. It's worse than that. To me, it's like you're going to a country where, to be honest, they don't have very much going for them — it's an extremely poor country. You take 14,000 babies who've done nothing to anyone and say, "you know what, the pathology that's actually rampant in your country, that we have a vaccine for, we're not going to give you." It's like, what the fuck? This is absolutely crazy. And I think this discussion dovetails very nicely with the other articles, because we don't really always grasp, because we've been vaccinating babies all along, what exactly we're talking about when we talk about babies not being vaccinated against hepatitis B. A few things I want to mention about the vulnerability of our patients: number one, we have to remember something known as age-dependent chronicity. If a newborn gets hepatitis B in their first year of life, they face a 90% risk of developing a chronic, incurable condition, while in adults that risk drops to only 5%. So catching this as a baby is a very, very big deal — it's not the same as catching it as an adult. In terms of lethality, chronic hepatitis B virus is highly destructive for our patient population — 25% of children infected prenatally will die prematurely from cirrhosis or liver cancer. And then the issue we deal with is this horizontal transmission myth — parents will refuse the vaccine and say, "well, I'm negative." But what we tend to forget is that hepatitis B virus survives on surfaces for durations as high as seven days, and it's transmitted via minor skin lesions or shared items, in a household or in daycares. And kids between the ages of one and five carry a 30% risk of lifelong chronic liver disease. So it's an extremely big deal. And when we have patients who refuse the initial birth dose — even if we're not talking about refusing it altogether, because honestly, at my institution, it's hard for me to know what's actually happening, since parents could tell me "we'll do it at the pediatrician," and that's in a couple of days, but I have no idea if these infants actually get it. So if we look at even a two-month delay, which is what was mentioned in the news by the administration, and we assume perfect adherence to that two-month dose, we're looking, according to projections, per single US birth cohort, at 90 additional acute hepatitis B infections, 76 additional chronic hepatitis B virus cases, 29 additional deaths, and $16.4 million in additional healthcare costs. So the burden is there. And I think that, unlike vitamin K, we tend to assume they'll get it done at the pediatrician, who they have an appointment with within, what, 72 hours of birth, or even five days of birth, but I don't know if the hepatitis B vaccine is actually given at that point in time, and that really frightens me.

Eli Cahan (13:36.24)

Yeah. Well, listen, I couldn't agree more with everything you said. By the way, I think the R word is racism. And if I'm not mistaken, there's a C word here too — colonialism. But those points aside, I just think this is when we

Ben Courchia (13:52.309)

We didn't, which, by the way, right — we didn't really get into the fact that Danish researchers are going into the middle of Africa to conduct experiments — human experiments. It's

Eli Cahan (13:55.875)

We didn't. Yeah.

Eli Cahan (14:06.022)

Yeah, no bueno. Long history of that one. Not good. And especially not something the American taxpayer wants to be paying for.

Ben Courchia (14:09.071)

Yeah.

Ben Courchia (14:15.728)

And by the way, this isn't like they applied for this grant — this is unsolicited money being offered to them. I think this idea of a no-bid grant, where basically they went and said, "do you need money to sustain this?" — this is crazy.

Eli Cahan (14:34.418)

Yeah, I think the other — I think the other—

Ben Courchia (14:36.792)

And they could potentially do the study in the US now, since we're delaying the vaccine so much.

Eli Cahan (14:41.202)

Yeah, well, they could do a natural history version of it — I don't know if we'd let them, I don't know what IRB (Institutional Review Board) would approve that here. But again, I think the no-bid piece of this is probably also infuriating to the legions of our colleagues — young investigators, previously NIH (National Institutes of Health)-funded people, who are now getting exceptionally high scores and not getting funded, seeing research projects die, seeing postdocs and postgrads laid off and sent back to the countries they're coming here from, leaving their families because they're so devoted to science, and now they have to go back and do that — or go to European countries that say, "hey, there are a bunch of smart people who are now free agents, let's go get them." I'm sure this is infuriating to all of them. It's not the way the process is even supposed to work on paper, so there are legality questions too. I think the other thing here that struck me about this reporting — Katherine's reporting — and the effects we're seeing now on hepatitis B, obviously not just from the study, but from the broader conversation around hepatitis B, is that these are the kinds of studies people come across when they say, quote, "I've done my own research." These are the studies that pop up, and that

Ben Courchia (15:54.724)

Yeah. And it's very important — that's also why I was mentioning the potential ramifications of delaying by two months. This idea that delaying by two months — myself included, in the beginning — is a safe compromise, "at least they get it eventually" — it's not a safe compromise. It is not safe for these infants to delay their dose by two months. It increases the risk of infection, of chronic disease, of mortality. I think

we need this data to have evidence-based talking points, data to provide families that goes beyond just our opinion, or "the way we used to do things." That's critical, because we need to present the data. We need to be good advocates for evidence-based practices. And delaying the birth dose is not going to cut it.

Eli Cahan (16:48.85)

And we need to be aware of these studies out there on the internet, that maybe an AI chatbot is pulling into its summaries when somebody asks, "should I get the hepatitis B vaccine, are there dangers associated with it?" and it pulls up, "hey, there's a study from West Africa that shows there are dangers associated with it." We have to read these studies, we have to know they're out there, we have to engage with this head on.

We have to say to families, "I understand where you're coming from — we both want the same thing, which is health for your baby, so let's talk about the risks and the benefits." That's something we have to address head on. At the same time, if you're inclined to solve systems-level issues, you can call your Congress people and say, "what's going on with the NIH? Why are we giving out blank checks to unsolicited proposals, while my wonderful colleagues can't get funding to do things that

for years we've decided are important?" Anyway, lots, yeah.

Ben Courchia (17:45.134)

Huh. Yeah. Especially with all the conversation about stopping efforts to fund research outside the US — like a year ago, two years ago, where every initiative outside the US that we were funding was shut down — and now we see that this can continue? Give me a break. And by the way, you can find-

Eli Cahan (18:10.874)

Yeah. Unless you're a Danish couple — then you can get funded. Then we'll pay for it.

Ben Courchia (18:14.136)

Yeah. And the tragic thing for me is, I have some pride in being an American citizen — it took me some time to become a citizen — and it's like, you look at this study in the news, and you'll find it: it's the "Guinea-Bissau, US-funded hepatitis B study." US-funded. Why are we even tied to this? It's just crazy. Anyway, I think that does it for us today, we're over time.

But thank you, thank you, Eli. All right.

Eli Cahan (18:46.588)

Thanks