Basmah Safdar: Why Women Experience Illness Differently

Transcript

Harlan Krumholz: Welcome to Health & Veritas. I’m Harlan Krumholz.

Howard Forman: And I’m Howie Forman. We’re physicians and professors at Yale University. We’re trying to get closer to the truth about health and healthcare. Our guest today is Dr. Basmah Safdar. But first, we always check in on current hot topics in health and healthcare. And I asked you specifically yesterday, Harlan, whether you would be willing to talk about the new access initiative out of CMS. And I think you said you’ll try to do it.

Harlan Krumholz: Glad to do it, Howie. I always like when you tee me up on something. But before I get into that main story, I wanted to start with something which may be one of the most sweeping public health experiments ever. Ever. Australia has now become the first country in the world to ban all social media accounts for anyone under 16.

Howard Forman: I saw that. Yes.

Harlan Krumholz: I don’t know if you realize, but this includes TikTok, Instagram, Snapchat, YouTube, Facebook, X, Reddit, Twitch, and others.

Howard Forman: And really ban, right? A parent can’t set up an account with a child?

Harlan Krumholz: Overnight, hundreds of thousands of accounts were logged out or shut down.

Howard Forman: Wow.

Harlan Krumholz: Platforms are required to verify ages using tools like facial analysis or risk fines up to over $30 million. And I think it’s so interesting. The motivation’s pretty clear. The Australian government found that 96% of kids aged 10 to 15 use social media. And seven in 10 had been exposed to harmful content, including self-harm material, violent misogyny, grooming attempts. And it’s interesting, because it sparked a very divided response. Some teens say they feel like an entire part of their life has been erased, because they had all of this information, all these contacts and pictures and all this stuff. Parents, though, who have been worried about online harm say they feel relief. And experts are asking whether this age verification technology can actually work or the teens will move into the darker corners of the internet, where they figure out how to go around it.

YouTube and Snapchat, for example, have warned the ban may actually reduce safety by driving kids off supervised accounts. So, the Australia eSafety Commissioner says the country will be collecting data on sleep, mental health, school performance, social engagement. This is in essence a large national experiment, not just policy. It’s a natural experiment now, where they’re going to look at an unprecedented scale whether they change these sort of habits. My own feeling is that there is a growing literature suggesting that social media as it’s used today has untoward negative effects on the mental health of teens. And you know this exposure to much of this content can’t be good for people. Can’t be good form them.

Howard Forman: Well, and you talked about this just two weeks ago or three weeks ago on the podcast, where you showed that the effect of taking just a two-week, I think, sabbatical from social media among adolescents had a dramatic improvement. They self-reported improve to mental health, including older adolescents.

Harlan Krumholz: So, the question is, much like cigarettes, how much proof do you need before you start employing new changes? How much harm could it be to take teens and put them back where they were 15 years ago, which is not really using social media? I want to say I salute Australia for this, especially the fact that they’re going to study the effects. And I think we have enough information to say that there may be enough harm that we should pause, and we should study, and learn, and maybe we should learn from Australia. But I want to say this is a very important thing.

Howard Forman: I mean, these are very vulnerable kids, these ages.

Harlan Krumholz: So, let me just jump into this other topic that you had mentioned. I think it’s really important. It’s this Medicare initiative that could shape how we care for chronic disease for the next decade. It’s called the ACCESS Model. ACCESS stands for “Advancing Chronic Care with Effective, Scalable Solutions.” It’s a 10-year national test beginning in 2026. And it represents one of the biggest shifts in how Medicare pays for chronic care in decades. The motivation for this is that people with Medicare have conditions like high blood pressure, diabetes, chronic pain, depression. They often need support between clinic visits. You know, medical system is built to look at people in these junctures, but a lot happens between visits, but our system doesn’t pay for this kind of help. Medicare pays for the office visits and procedures, but not, to a large extent, the ongoing monitoring, coaching, medication, titration or the digital tools that help people manage their conditions during daily life.

So here’s what’s different about this program. Instead of paying for specific devices or programs, that kind of fee-for-service model might just escalate utilization without actual improvement. Medicare will pay organizations based on whether they improve outcomes that matter for these chronic conditions. And so, CMS is clear about this. They’re not paying for devices. They’re paying for improvement. And they’re not asking clinicians to take on total cost of care risk. That’s been, historically they’ve done that. The focus is very targeted. Improve the control of blood pressure, blood sugar, reduce pain, improve depressive symptoms, show progress across groups of patients, and you will receive a monthly payment to support that work.

And all this has to be physician-led. There was an AMA interview recently with Abe Sutton, who directs the Innovation Center, which developed this, that emphasizes this. And he said physicians can choose whatever tool they want to help.

Howard Forman: Right.

Harlan Krumholz: It’s not about saying, “You have to use X, Y, or Z.” And they can use, let’s say for connected blood pressure cuffs, to nutrition apps, to remote titration programs. Medicare is not picking the tools. Medicare is setting the outcomes and letting clinicians and innovators figure out how to reach them. So, I think this is going to be very interesting.

Howard Forman: I’m simultaneously optimistic, but I’m always skeptical. There are literally dozens of companies queuing up to sell to providers to try to facilitate this. And I’m always just Eeyore or a skeptic about this, but at the same time, very hopeful that this could work. This is not something that just arose in the last few months. There have been, for years, people beating the bushes, including you, for such models.

Harlan Krumholz: Well, this could unleash a lot of innovation, because now the business model could line up with what the federal government’s trying to accomplish. You should know that ACCESS arrives same week as two other federal moves. The FDA announced a new pilot called TEMPO, that allows selected digital health tools to be used with more regulatory flexibility while companies collect real world data. And HHS released a new AI strategy that’s designed to modernize public health and clinical operations. These three together send a clear message that the federal government is pushing hard into accelerating technology to support chronic care, building payment regulatory and data infrastructure. The political strategy is interesting, because CMS highlighted endorsements from a wide range of groups.

So, they came out with this, but they had done their homework before and they came out with American Psychiatric Association, American College of Cardiology, AMA, National Kidney Foundation, the Family Practice Association, a whole range of others that were on a slide that said, “We support this effort.” And I think this is important, because many years, CMS would come out with something and catch these organizations by surprise, but now there’s a real alignment and real coming together. I think, like you said, there are going to be concerns between technology vendors and physicians. How is this all going to work? How can you demonstrate the outcomes and what timeframe?

For me, the scientific question is most important. It’s essentially a national experiment, going to go on for a decade. Can technology support chronic care, improve outcomes? And when there’s incentives, can it accelerate the investments, the adoption, and the benefit to patients? If it succeeds, it could reshape how Medicare manages chronic diseases and establish a payment model that rewards improvement rather than activity. For me, as an outcomes researcher, I really embrace this idea that they want to pay for actual results. If it falls short, it’ll just join a long line of efforts that promise transformation but failed to deliver. But I salute them. Abe Sutton’s a visionary. They’re trying to make a difference and the focus on outcomes.

Howard Forman: This was the original purpose of CMMI, the Center for Medicare and Medicaid Innovation, built into the ACA. So, this is something that has bipartisan support, and we want it to succeed.

Harlan Krumholz: Yeah. And I’ll just say, the question is, can we redesign a system? We’re doing the right thing for patients, is also the thing that the system pays for. That would be great. Lovely if that happens and we’ll be watching, but this is a really interesting effort by them and just out. Great. Let’s get to our interviewee, Basmah. Would be wonderful to talk to her.

Howard Forman: Dr. Basmah Safdar is a professor of emergency medicine and the newly appointed director of Women’s Health Research at Yale, the university’s interdisciplinary research center focused on studying women’s health and understanding sex-based differences in diseases. She also serves as director of the Emergency Department Chest Pain Center at Yale New Haven Hospital, and development for the Department of Emergency Medicine, and leads the Yale Coronary Microvascular Dysfunction Registry. She is an internationally recognized scholar in sex- and gender-specific research, particularly in microvascular health, and has led numerous clinical trials on microvascular dysfunction. She completed her MD at Aga Khan University in Pakistan, her master’s degree in epidemiology at Harvard, and did her residency in emergency medicine at Yale, which is when I had the first opportunity to meet her.

And I want to start off with a pretty much less related topic to what will be the theme of the day. And that is something you and I have talked about, which is, we’re in the midst of a time where immigrants are less embraced and even international medical graduates are finding a harder time coming to this country. You and I have talked about this offline. You are an international medical graduate and a scholar, a huge success, and we are so grateful to have you. Do you want to just speak to what your journey was like coming here as a very young woman from Pakistan and what that career path has meant to you?

Basmah Safdar: Yeah. Thank you, Howie. I feel like both of you, you and Harlan, have been part of my journey from the start. And so, it feels like a full circle, especially as two people who I admire so much as people who like to think differently and evolve to make an impact. And I think that’s really important to me. That is what I’ve been seeking when I came all the way from Pakistan. And in many ways, I was inspired to enter medicine part of where I started. And so, Howie, you and I have talked about my growing up in Pakistan and Karachi, which is a large cosmopolitan city, but probably didn’t talk about that I actually grew up in a very poor neighborhood, where I did not have access to healthcare. Whenever we would get sick, I would be taken to a clinic called Rafah-E-Aam, which literally translates into public welfare.

And it did its job. I’m alive and I survived, but ah, didn’t do a good job in vaccinations. So, even though I got all the vaccinations, I got measles, mumps, rubella, chickenpox, and so on and so forth. I mean, I share that because even though at any point I didn’t think I had access to care, I had neighbors who had even less. And so, that disparity, and that access and equity lens has been important to me. It’s been the reason I’ve strived to look for opportunities. It drew me to go for scholarships for the best school in the city that opened the doors for the best medical school in the region, that opened the doors to come to Harvard. And I came to the U.S. with that bright shining light of what the U.S. offers in learning from people like a place like Yale. I ended up going to Harvard and then got my residency here.

So, one thing led to another, but it was the draw for the innovation, for the excellence, for the multitude, and the stimulation, and the intellect, and opportunities, and ways to make a difference that drew me here. And my journey has been helpful. And part of it, I’ve actually partly not shared a lot of it as before, but I do think I was looking for that inspiration when I started. And I hope I can be part of that journey for others as well.

Harlan Krumholz: You’ve done so incredibly well. It’s such a privilege to know you. What have you found have been the most important challenges for you as you’ve gone along? I mean, it’s one thing to dwell on the successes, but sometimes people listening really appreciate hearing some of those moments where you had doubts and weren’t sure. And what were the biggest challenges along the way? And how did you cope with those?

Basmah Safdar: It’s a good question. I would say a word I didn’t know before, but I’ve come to learn is “resilience” and not being stopped by barriers. Barriers happen in all aspects. I talk about the access, but I also talk about being a woman in a third-world country. At all the points that I was told no, I just tried to look around and look for something else. And one of the other observations was in many ways being a woman came from a sense of protection. So, I came from a country where you would not have to stand in line, because you would always be offered because you’re a woman. There will always be people who help to carry weights or groceries, the sense of protection. But in that process, what I didn’t realize at that time, but I inadvertently fought against was women became invisible.

So, the opportunities, like you would go to medical school so that you become a trophy wife and then you would be asked not to work. And what I thought was a cultural barrier and I came from a third-world country to a first-world country, came here, I realized that that actually still exists. So, in clinical care, that was true in taking care of women. Women disappeared when it came to science, to clinical applications, as faculty in advancement. And so, putting a spotlight on what is right and not taking no for an answer, but like finding ways and bringing people... The other thing I’ve realized is people don’t do that intentionally all the time. Really, it’s about just creating that lens for them and making them part of the dialogue and the conversation.

Howard Forman: Along those same lines, 55% of medical students are now women, but that was obviously not the case even 50 years ago; 60 years ago, it’s wildly not the case. A lot of people might ask, why do we have women’s health research? And you gave us a short answer to it back when you were on the podcast at the live Innovation Summit podcast session. I’m curious to hear you tell us a little more expansively about what motivates you to do women’s health research. What are the opportunities that you’ve been involved in through your work in the ER? And what do you see now taking on your new leadership role for this center more broadly within Yale New Haven Health System?

Basmah Safdar: It’s something that’s really near and dear to my heart. I fell into women’s health. I didn’t start as women’s health. I didn’t see... I was an emergency physician. I was being just fascinated, taking care of patients, really the troubleshooting, bringing that lens of seeing people holistically. When I finished residency and first became the medical director for the chest pain center, I was tasked with improving efficiency, and length of stay, and patient outcomes, and value-based care. And I basically started a registry and collected data. And in looking at the data month after month, realized that more women were coming repeatedly with chest pain. They would have normal stress tests, and then they would go home saying they didn’t have heart attack or ischemia or angina. And they kept coming back. And so, every month, they would keep coming back and looking at just that recurrent chest pain.

It was right around the time when there was an NIH-funded study, that first described that the biology of ischemia or angina may be different between men and women, with women maybe having small vessel disease as opposed to men having more likely to have large vessel disease. And this was fascinating. It was the first time I was like, maybe the biology may be different between men and women. And then having said that, that work was done on patients who were getting angiography. So, they had to be very specialized people to get a very specialized procedure that was invasive. It was not something I could offer in the emergency department, but it motivated me to go back, get a master’s from Harvard in epidemiology, go to a vascular lab, learn some of the skills on how to measure microvascular dysfunction or small vessel disease in the emergency department.

And we were able to use the infrastructure we had to turn it into a clinical lab. So, we started with an ultrasound and then we moved on to a cardiac PET CT to describe what small vessel disease was. And then we just started following those people. And because I’m a generalist, I am disease-agnostic. Well, the same women who were describing more symptoms with small vessel disease. In talking to them, you could see that they had other manifestations. They were more likely to have low cognition. They were more likely to have PCOS, which is polycystic ovarian disease. They were more likely to have migraines. So, with all these connections, which people when they were in there studying, they were much smarter people studying these diseases from a disease standpoint, were probably missing that.

And so, what I say, what I bring to that table is like bringing that generalist lens of looking at people holistically. So, in my own path, I started studying then the heart-brain connection. And then when COVID came, it was microvascular dysfunction that was systemic. It was really the systemic lens that made me interested in looking at the sex differences. And then we partnered and did clinical trials that led to some of the long COVID studies as well. And Harlan, you’ve been part and parcel of some of that work, which continues. There’s a lot of interest in how some of these viral conditions are now converted into chronic conditions. And again, while men were dying more commonly with COVID in the acute setting—again, a sex-specific difference, because of the immune response, that Akiko was one of the first who actually showed that, more women have the higher inflammatory response that gets prolonged. And they’re more higher risk for having long-term chronic conditions with COVID. COVID being one example, but you can translate into many viruses.

And so, that kind of work and that kind of lens is what I’m hoping to bring to the center. The center actually is one of the first academic centers that put that spotlight of women’s health beyond bikini medicine. Every cell has a sex. And hence, every cell has to be studied from the biological differences, but that are difference between males and females. And Carolyn Mazure really was a visionary in looking at this from 30 years ago, when the conversation was just starting by really making the focus of the center and has done—

Howard Forman: And she was the founding director, right?

Basmah Safdar: She was the founding director [of the Women's Health Research at Yale at the Yale School of Medicine]. And really, people like her changed the field. I should start with the context before we go on like where we are, the context of where we started. Women’s health really came into recognition about 30 years ago, so 1993. So, a little more than 30 years ago. And that was in the context that FDA 1977 had said women of childbearing age should not be included in clinical trials, because of the thalidomide controversy and that big thing. And so, for about 15 years, systematically, women were not included. And someone at some point recognized that they were being excluded. And as a result, we were not seeing data. And so, 1993 was when NIH created the Office of Research on Women’s Health.

Harlan Krumholz: At times where for once there was an NIH director who...

Basmah Safdar: Was an NIH director.

Harlan Krumholz: ... was a woman.

Basmah Safdar: Right. Exactly.

Harlan Krumholz: Bernadine Healy. Yeah.

Basmah Safdar: That’s right. And then it was the first time that NIH mandated including women in clinical trials. And then fast-forward, 2016, Janine Clayton mandated with Francis Collins, including males and female cell lines in animal research. And so, fast-forward the last 30 years, we at least now have data. So, the work now is because of all those visionary people, women were included. Harlan led one of the first NHLBI studies looking at sex differences that I had the pleasure of being part of, to actually put that spotlight beyond ischemia on heart attacks. And how men and women can have different types of heart attacks and you can have different classifications. So, they have actually similar outcomes.

What was bulked together under syndrome X, because we didn’t understand it, was actually different biology. We just didn’t have the tools to diagnose them. So, now we actually have some tools to diagnose them, but in very specialized centers. When I started trying to describe coronary microvascular dysfunction in the emergency department, there was nobody doing an angiography here at Yale to look at the gold standard test. Now we have someone who does that, but it can only be offered even in the largest of the programs, 150 women. I am seeing six million patients who come to emergency department with chest pain each year. How do we take those tools, now that we know, understand biology, and turn it into diagnostics, and prognostics, and therapeutics, that we can offer to the masses?

So, I think that’s where the work is. That is, I think, the second phase of where women’s health research is. And the good news and the promising news is that is being recognized. And so, 2025 has seen some very promising advances. So, one, there’s this lens. Even American Heart Association has put this lens and American Cancer Society has put that lens. There is a lens on looking at women across the health span and not just the lifespan. So, in general, more men die and earlier. Women tend to outlive men, so there’s a sex difference there, but women often will have worse quality of life. And so, there has been a shift in looking at not just mortality, which is absolutely important, but that has been the core of our research, to symptoms and quality of life. And that shift has been actually picked up by a lot of companies. So, there’s a lot of private and foundation funding has just in the last three months have stepped in.

Howard Forman: And I want to definitely come back to that one from the investor and the pilot project program, but I want to make sure that Harlan also gets in...

Harlan Krumholz: First, I was going to make sure you caught what she said about the bikini medicine. Some listeners may wonder what she’s talking about bikini medicine. Well, it’s just like the focus on sex organs, really.

Howard Forman: No, no, yeah, yeah.

Harlan Krumholz: ...beyond and saying to all cells. In other words, when we talk about women’s medicine, it’s not just—

Howard Forman: It’s not just, right.

Harlan Krumholz: ...reproductive health, it’s not just the breasts and genitalia that are different. Everything’s different. I’m only just highlighting that she said that, but I want to make sure listeners pick up on the fact that this was one of the big pivot points, which was, you know, it’s not just saying women’s health means go see your OB/GYN. And so, women’s health is much broader than that. And that’s what—

Howard Forman: Every cell has its own destiny based on their genetics.

Harlan Krumholz: And that’s why the studies as they’re published needs to be looking more at sex-stratified results. We need to be thinking about this as a thing that we’re not just trying to push everyone together, but we’re trying to understand what those differences are as well.

Howard Forman: I wanted to come back to one last topic before we wrap up, and that is another area where Harlan and I have intersected, thankfully, is Jessica Federer, who is my former student, has worked with Harlan separately, and has had a real great career in the life sciences industry, communications innovation, and so on. She’s launched a women’s health innovation fund recently. And I just want to talk to you, because you’ve not been necessarily targeting venture capital investments in the past. That’s not like what your work has been about, but you are embracing the idea that a lot of the great work that happens does require commercialization and translation into the private sector. Tell us a little about what’s going on in that space for you.

Basmah Safdar: Yeah. I’m glad you brought that up, because I do think the economic model of women’s health research, and why we need to invest in women’s health research, and in women’s health, is probably one of the most positive things that have happened in the last few years. So, Jessica Federer launched the Women’s Health Fund. I’m actually the scientific advisor for her, founding scientific advisor for her fund. It’s a $60 billion investment in women’s health to fill the gap in research. And that is really based on the fact it’s a fund-to-fund model. And you’re right, I didn’t think about it previously, but I’ve always thought about a multimodal strategy. Even in my research, I have diverse funding. In order to make an impact and move the needle, we have to think differently in traditional and non-traditional sense.

What is the really amazing part in the last few years has been... Actually, McKinsey Health Institute published a report about two years ago. It was funded by Women’s Health Access Matters, which is a nonprofit that is led by a businesswoman. So, a very different lens of why this should be important, that made a case for the first time that there are economic returns if you invest in women’s health. And so, for every dollar that is spent in women’s health, the society gains three dollars back. And they built it on big diseases. And to your point, Harlan, demonstrated that female-specific factors, such as maternal health and endometriosis, and PCOS is only 5% of the diseases that intersect women.

Ninety-five percent are led by the top five things that women die of, are heart disease, and stroke, and cancer, and mental health, and COVID, and sepsis. And the things that affect their health are very different from female-specific conditions. And so, while it is important to invest in both, and that’s where a lot of previous funding has been, there has been a new opportunity that has been introduced of investing in women’s health. They demonstrated through their work or put a spotlight on it, we knew this always, that women are half of the population. They are 85% of the health consumers, particularly, and the decision-makers, and hence VC and companies have to actually target it. That’s the underlying basis for the Women’s Health Fund, but there are other private investors that have similarly funded.

So, Gates Foundation just announced $2.5 billion to invest in women’s health. Foundation of Women’s Health has just announced they actually gave a million-dollar last year—they launched last year—but very much targeting autoimmune conditions, cardiovascular condition, cancer. And they changed their themes each year. This year, they’re putting $5 million. The Nuttall Foundation just launched research grants that are giving anywhere from $500 to $5 million, again, investing in these specific conditions. So, those are the research perspectives, but the VC companies are similarly putting in money. The target, where they see the investment opportunity, is $66 billion by 2035. So, the Milken Institute just launched a women’s health network, and that is being chaired by Jill Biden, which was the follow-up to the White House Initiative [on Women’s Health Research], but they’re taking the same energy and the same players to bring the same people to the conversation, and elevate the conversation, and put a spotlight...

Harlan Krumholz: Continue the momentum. Continue the momentum.

Basmah Safdar: To continue the momentum.

Howard Forman: That’s great.

Harlan Krumholz: Amazing. It’s so great to talk with you. Thank you so much.

Howard Forman: Thank you so much for coming on. And we look forward to following you and having you back again.

Basmah Safdar: Thank you for the opportunity. And I would say, I would end by inviting, for anybody who is listeners, we just launched our pilot awards. And so, for anybody who wants to participate, they can go to our website, which is—

Howard Forman: We’ll put it in the show links as well.

Basmah Safdar: Okay, perfect. And the deadline for that is in a week. And for anybody who wants to be a part of the membership, we are inviting and just forming these. And anybody who has ideas, we would love for them to contribute.

Howard Forman: That is awesome. Thank you.

Basmah Safdar: Wonderful.

Howard Forman: That was great.

Harlan Krumholz: Well, that was a terrific interview with Basmah, but now I want to get to your part. I’m always interested in what’s on your mind this week.

Howard Forman: You got it. I think a lot of people know this topic. So, the newly formed CDC Advisory Council on Immunization Practices, or ACIP, met last week and not surprisingly made changes to our vaccine practices, or at least attempted to. The news media are appropriately highlighting much of this because it is extraordinary. The existing practice around universal hepatitis B vaccination right after birth is considered one of the greatest successes in public health of late. And nobody has actually raised a new concern about safety or efficacy to suggest making a change. But there is nuance here that needs to be emphasized. The new policy does not take vaccines away. It does not stop paying for them through all the usual means and it does not stop recommending them in the highest-risk groups. Those are mothers who test positive for hepatitis B or who have not been tested or have an unknown status.

It emphasizes risk stratification and shared decision making beyond that. So, we can talk for a minute about that, and then I want to hear your thoughts, obviously. Hepatitis B vaccine is almost absurdly safe. It is a yeast-based vaccine that has only one serious side effect that I’m aware of. And that’s about a 1 in 600,000 to 1 in [one million] chance of a serious allergic reaction, such as anaphylaxis. If you had this reaction at home, it could be fatal. But in this case, it is administered in a healthcare setting and we’ve ready ability to reverse these effects. In large series, there have been zero cases of death associated with anaphylaxis from hepatitis B vaccination. I’ll come back to that.

Using more than a decade worth of data, a recent study reviewed all adverse events, including deaths that might be related to hepatitis B vaccination. And they found 27 deaths in infants documented during the time as occurring proximate to hepatitis B vaccination over this 10-, 11-year period. Now, remember, 40 million births occurred during this period, and almost all of them were vaccinated. But in this review, not one of these deaths, the 27 deaths I mentioned, was seen as being due to vaccination. And while it’s sad to contemplate, it is worth knowing for our audience that 100,000 or more neonates died during this period due to a host of causes. So, 100,000 infants or neonates died. 27 of them occurred proximate to hepatitis B vaccination and zero were felt to be actually due to the hepatitis B vaccination.

The vaccine is enormously effective, somewhere between 75% and 95% effective. Now, most, not all, but most neonatal hepatitis cases are transferred from the mother. And a mother without hepatitis cannot transmit it, but other people can as soon as the neonate is delivered. It is not just through sex or needles that hepatitis is spread. In some parts of the world, hepatitis remains endemic. Ninety-seven million people in the WHO, W-H-O, Western Pacific region, and 65 million in the WHO African region are chronically infected. Tens of millions are infected in other parts of the world. It is not as though you have no chance of having contact with someone who is infected.

Even if you are a perfectly healthy couple testing negative for hepatitis B, the weight of personal risks do appear to exceed the risk of vaccination. Though everyone is entitled to their own risk tolerance, but the collateral benefits to society from a universal vaccination recommendation are far greater than just to the individual. And just finally, the universal vaccination recommendation was not a mandate. It just meant that parents were being told this was the guidance. They still had informed consent. And many states will not follow the new policy and will continue to adhere to the old one, mostly because most medical societies still seem inclined to support the existing successful policy.

We may yet have a natural experiment to get to see whether places that change their policy begin to see new neonatal hepatitis cases. If we do, you should know this: 90% will develop chronic disease, and 20% to 25% of those will die from this. And to me, those are very sobering statistics.

Harlan Krumholz: So, to me, this is a complicated issue. And I may come out on the other side of this, which may surprise you. But I really do believe that people need to be able to weigh their own risks and benefits. I mean, I’ll ask you this. Do you think the national speed limit should be 55?

Howard Forman: I think the evidence suggests that it should be, but I think people don’t comply with it and we don’t actually enforce it.

Harlan Krumholz: Well, you know that when we went to 65, a lot of people died. We could actually go to 50 and actually save a lot of energy and fewer people would die. We could mandate that. We could mandate it tomorrow. We could save a lot more lives than hepatitis B vaccine would, but we don’t.

Howard Forman: But there’s a huge trade-off there.

Harlan Krumholz: The trade-off is time, but it’s also gas expenses. I mean, there’s a lot of things that... Well, I guess that’s not a good one for asking for people individual choice, but I’m just saying that the society makes a lot of different choices. This doesn’t mean I agree with the changes that went on with the immunization panel, but it does mean that I do think that we may have gone too far in what we’ve mandated. I even feel like in the pandemic, I mean mandating the vaccine, once we knew that it wasn’t going to reduce transmissibility.

Howard Forman: As I’ve said many times, that’s a very different situation. We got new data that really changed the calculus. It dramatically changed the calculus. You’re talking about here a situation where there is yet to be a case that someone can point to over the 33 or 34 years of this universal vaccination program, where a child has been harmed. I mean, literally.

Harlan Krumholz: So, just, what’s your principle there? If I’ve got an intervention that’s mostly beneficial and has low harm, we should mandate it.

Howard Forman: I think that you have to weigh benefit versus harm. In this case, you talk—

Harlan Krumholz: So, what about statins? Should we mandate statins for everyone who’s got a cholesterol over 190?

Howard Forman: So, first of all, remember—

Harlan Krumholz: Do we mandate blood pressure medications for everyone who’s blood pressure is over 200?

Howard Forman: Just remember what I said earlier, this has never been a mandate. It’s never been a mandate.

Harlan Krumholz: I know.

Howard Forman: But we’re making a recommendation, and the recommendation has always included the ability for people to opt out. It’s always included that.

Harlan Krumholz: I’m not sure people—

Howard Forman: And people have opted out. It’s just that from a behavioral point of view, when you have an opt-in versus an opt-out system, you have different behaviors that occur. And when you’re able to say to people, “Here are the recommendations, here are the risks, here are the benefits, we recommend doing it,” versus, “We’re giving you an independent... here are some benefits, here are some risks, you make a choice. We don’t want to change your opinion.”

Harlan Krumholz: Well, we could do the same for statins. We could say everyone who’s got a cholesterol over 190, you’ve got to opt out of getting a shot to lower your cholesterol.

Howard Forman: First of all, there are real trade-offs with statins as well. Statins are not without side effects.

Harlan Krumholz: Very safe. Very safe.

Howard Forman: Oh, come on. There’s still brain fog!

Harlan Krumholz: Oh, my God, you’re one of those people?

Howard Forman: I am one of “those people”—

Harlan Krumholz: “Brain fog”?

Howard Forman: ... because I’ve been on this for 30 years—

Harlan Krumholz: “Brain fog”—with statins?

Howard Forman: ... or 25 years.

Harlan Krumholz: All right.

Howard Forman: I do think. I mean, there are side effects from statins.

Harlan Krumholz: You’re a conspiracy therapist!

Howard Forman: You think brain fog doesn’t exist?

Harlan Krumholz: No, not for statins.

Howard Forman: Okay. Well, I mean, that’s one of those things where then I am a conspiracy theorist.

Harlan Krumholz: We can disagree. We can disagree. All right. Well, this was fun. That was a great segment. You’ve been listening to Health & Veritas here with Harlan Krumholz and Howie Forman.

Howard Forman: How did we do? To give us your feedback or to keep the conversation going, email us at health.veritas@yale.edu or follow us on LinkedIn, Threads, Twitter, Instagram, or anything that you want to go to. Instagram is our new favorite platform.

Harlan Krumholz: If you’re over 16. If you’re over 16. If you’re under 16...

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Howard Forman: Health & Veritas is produced with the Yale School of Management, Yale School of Public Health. To learn more about the Yale School of Management MBA for Executives program, visit som.yale.edu/emba. To learn more about the Yale School of Public Health’s Executive Master of Public Health program, visit sph.yale.edu/emph.

Harlan Krumholz: And if we’re any good at all, it’s because of our superstar undergraduates Tobias Liu—

Howard Forman: That’s for sure.

Harlan Krumholz: ... Gloria Beck, our marvelous producer, Miranda Shafer. And of course, I get to work with the best in the business, Howie Forman. Thank you, Howie.

Howard Forman: I appreciate that, Harlan. Right back at you. And I do want to say they tolerate us, which is even more important than them helping us.

Harlan Krumholz: Talk to you soon, Howie.

Howard Forman: Thanks, Harlan. Talk to you soon.