New Podcast: "Making Sense of Science"
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
Making Sense of Science features interviews with leading medical and scientific experts about the latest developments and the big ethical and societal questions they raise. This monthly podcast is hosted by journalist Kira Peikoff, founding editor of the award-winning science outlet Leaps.org.
Episode 1: "COVID-19 Vaccines and Our Progress Toward Normalcy"
Bioethicist Arthur Caplan of NYU shares his thoughts on when we will build herd immunity, how enthusiastic to be about the J&J vaccine, predictions for vaccine mandates in the coming months, what should happen with kids and schools, whether you can hug your grandparents after they get vaccinated, and more.
Transcript:
KIRA: Hi, and welcome to our new podcast 'Making Sense of Science', the show that features interviews with leading experts in health and science about the latest developments and the big ethical questions. I'm your host Kira Peikoff, the editor of leaps.org. And today, we're going to talk about the Covid-19 vaccines. I'm honored that my first guest is Dr. Art Caplan of NYU, one of the world's leading bio-ethicists. Art, thanks so much for joining us today.
DR. CAPLAN: Thank you so much for having me.
KIRA: So the big topic right now is the new J&J vaccine, which is likely to be given to millions of Americans in the coming weeks. It only requires one-shot, it can be stored in refrigerators for several months. It has fewer side-effects and most importantly, it is extremely effective at the big things, preventing hospitalizations and deaths. Though not as effective as Pfizer and Moderna in preventing moderate cases, especially potentially in older adults with underlying conditions. So Art, what's your take overall, on how enthusiastic Americans should be about this vaccine?
DR. CAPLAN: I'm usually enthusiastic. The more weapons, the better. This vaccine, while maybe, slightly less efficacious than the Moderna and the Pfizer ones, is easier to make, is easier to ship. It's one-shot. You know, here there's already been problems of getting people to come back in for their second shots. I would say 5... 7% of people don't show up even though you remind them and you nag them, they don't come back. So a one-shot option is great. A one-shot option that's easy to, if you will, brew up in your rural pharmacy without having to have special instructions is great. And I think it's gonna really facilitate herd-immunity, meaning, we'll see millions and millions and millions of doses of the Janssen vaccine out there as an option, I'm gonna say, summer.
KIRA: Great. And to be fair, it's worth mentioning that the J&J vaccine was tested in clinical trials after variants began to circulate, and it's only one-shot instead of two, like the other vaccines, and it gets more effective over time. So is it really fair to directly compare its efficacy to the mRNA vaccines?
DR. CAPLAN: Well, you know, people are gonna do that. And one issue that'll come up ethically is people are gonna say, "Can I choose my vaccine? I want the most efficacious one. I want the name brand that I trust. I don't want the new platform. I like Janssen's 'cause it's an older, more established way to make vaccines or whatever." Who knows what cuckoo-cockamamie reasons they might have. To me, you take what you can get, it'll be great. It's way above what we normally would expect, those 95% success rates are off the charts. Getting something that's 70% effective, it's perfectly wonderful. I wish we had flu shots that were 70% effective.
And the other thing to keep in mind is we're gonna see more mutations, we're gonna see more strains. That's just a reality of viruses. So they'll mutate, more strains will appear, we can't just say, "Oh my goodness. There's a South-African one or the California one or the UK one. We better... I don't know, do something different." We're just gonna have to basically resign ourselves, I think, to boosters. So right now, take the vaccine. I'm almost tempted to say, "Shut up and take the vaccine. Don't worry about choosing."
Just get what you can get. If you live in a rural community and all they have is Janssen, take it. If you're in another country and all they ship to you is Janssen, take it. And then we'll worry about the next round of virus mutations, if you will, when we get to the boosters. I'm more concerned that these things aren't gonna last more than a year or two than I am that they're not gonna pick up every mutation.
KIRA: So on that note, shipping to rural places or low-income countries that lack the ultra-cold freezers that you need for the super effective mRNA vaccines, the Janssen vaccine seems like a really great option, but are we going to encounter a potential conflict of people saying, "Well, there's "poor or rich vaccines," and one is slightly less effective than the other." And so are we gonna disenfranchise people and undermine their actual willingness to take the vaccine?
DR. CAPLAN: Well, it's interesting. I think the first problem is gonna be, "I have vaccine and I don't have any vaccine," between rich and poor countries. Look, the poor countries are screaming to get vaccine supply sent to them. I think, for example, Ghana received recently 600 million doses of AstraZeneca vaccine. It was freed up by South Africa, which decided they didn't wanna use it 'cause they thought there was "a better vaccine" coming. So even among the poorer nations or the developing nations, some vaccines are getting typed as the not-as-good or the less-desirable... We've already started to see it.
But for the most part, the rich countries are gonna try and vaccinate to herd immunity, you can argue about the ethics of whether that's right, before they start sharing. And I think we'll have haves and have-nots, herd immunity produced in the rich countries, Japan, North America, Europe, by the end of the year anyway. And still some countries floundering around saying, "I didn't get anything," and what are you gonna do?
KIRA: And I know you said to people, which is a very memorable quote, "just shut up and take the vaccine, whatever you can get, whatever is available to you now, do it." But inevitably, as you mentioned, some people are going to say, "Well, I just wanna wait to get the best one possible." When will people have a choice in vaccines, do you think?
DR. CAPLAN: I don't think you'll see that till next year. I think we're gonna see distribution according to where the supply chains are that the vaccine manufacturers use. So if I use McKesson and they ship to the Northeast, and that's where my vaccine goes, that's what's available there. If I'm contracted to Walmart and they buy Janssen, that's what you're gonna see at the big box store. I don't think you're really gonna get too much in the way of choice until next year, when then they're gonna say they ship three different kinds of vaccine, and I can offer you one dose or two dose... One of them lasts a year, one of them lasts 18 months. I don't think we're gonna have the informed choice until next year.
KIRA: Okay. And right now the steep demand is outstripping the supply, and there's been a lot of pressure put on the vaccine makers to ramp up as quickly as possible. Of course, they say that they're doing that and the government is pressuring them to do that, but when do you think we'll cross over to the point where vaccine hesitancy is a bigger issue than vaccine demand?
DR. CAPLAN: Yeah. So this is a really interesting issue. I'm glad you asked me this because I think it's got good foresight. The big ethics fight now is scarcity and who goes first, and the ethicists, including me, are having a fine old time arguing about healthcare workers versus policemen versus people who work for UPS versus somebody who's working at the drug store. Who's more important? Why are they more important? Who's essential?
Actually, I think most of that is nonsense, because what we've learned is that you can't do much in the way of micro-allocation, the system strains, and it doesn't work. You've gotta use some pretty broad categories like over 65, still breathing and working, and a kid. The kid will go last, 'cause we don't have the data, everybody else should get in line and the over 65s should probably be first 'cause they're at high risk. We can't do this. We stink at the micro-management of vaccine supply, plus it encourages cheating. So everybody's out there with vaccine hunters, vaccine tourism, bribing, lying, dressing up like a grandmother to get a vaccine. My favorite one was some rich people in Vancouver flew up to the Yukon and pretended to be Inuit aboriginal people to get a vaccine. That will all pass.
We'll have enough vaccine by the summer, more or less, that the issue will then be, "How are we gonna get to herd immunity or at least maximal immunity, knowing that we don't have data on kids?" People under 18, I think are something like 20% of our population. That means the best you could do is 80%. The other population still could be passing the virus, kids here or Europe or wherever. Well, the military refusal rate that I just saw was 30% saying no. I've heard nursing home staff rates, nursing attendants, nursing aids up at 40% to 50% saying no. So these are huge refusal rates, people are nervous about how it works, the vaccine. Some of them are like, "Well Art you take it. If you're still alive in six months, then maybe I'll take it, but I wanna see that it really works and it's safe." And other people say, "We don't wanna be exploited. We don't trust the government, whatever, to offer us these vaccines."
I'm gonna answer that was a long-winded way of saying we're gonna see some mandates, we're gonna see some coercions start to show up in the vaccine supply, because I think, for example, the military. The day one of these license gets... Excuse me, one of these vaccines get licensed, right now they're on an emergency approval, collect data for three or four more months, get the FDA to formally license the thing. I'd say between five minutes and 10 minutes, the military will be mandating. They have no interest in your objection, they have no interest in your choice, they know what the mission is. It's traditionally, we're gonna get you as healthy as we can to fight a war.
The fact that you say, "Gee, I might die." They kind of say, "Yeah, we noticed that, but that's in the military culture. We fight wars and do stuff like that." So they'll be mandating, I think, very rapidly. And I think healthcare workers will. I think most hospitals are gonna say 50% refusal rate among this nursing group? Forget it. We can't risk that. Nursing homes have been devastated by COVID. They're not gonna have aids out there unvaccinated. The only thing holding up the mandates right now is that we don't have full licensure. We have emergency use approvals, and that's good.
But it's a little tough to mandate without full license. The day we get it, three months, four months, we're gonna start to see mandates. And I'll make one more prediction, as long as I'm in a crystal ball mode. It won't be the government at that point that says, you have to be vaccinated. It'll be private business, 'cause they're gonna say, "You know what? Come on my cruise ship, 'cause everybody who works here is vaccinated." "Come on into my bar, everybody who works here is vaccinated." They're gonna start to use it as an advertising marketing lure. "It's safe here. Come on in." So I think they'll say, "If you wanna work on an airline as a flight attendant, you get vaccinated. We have vaccine proof. You can show it on your iPhone, on your whatever, you have a card that you did it." And so I think we'll see many businesses moving to vaccinate so that they can bring their customers back in.
KIRA: So private businesses, that's one thing, because people do not have to patronize those places if they don't wanna get vaccinated. But of course, this is gonna open up a can of worms with schools. Public schools, if they mandate teacher vaccines and you have to send your kid to school and you have to go to work at a school. What happens then?
DR. CAPLAN: Well, schools are gonna be at the end of the line. That's where we have the least data. So I don't think we're gonna see school mandates on kids, maybe not till next year. But we already have school mandates on kids. They were the first group to feel the force of mandates, because it turns out that measles and mumps and whooping cough are easy to get at school, sneezing and coughing on one another. Some states have added flu shots. Many states, California, Maine, New York have actually eliminated exemptions. The only way out for those kids is if they have a health reason. They're not even allowing religious or so-called philosophical or personal choice exemptions. COVID vaccines will just line up right next to those things.
Teachers will demand it, the pressure will be there. We'll have a lot of information by next year on safety. I'm even gonna say people are gonna be less tolerant of non-vaccinators. Now it's sort of like, "Wow. Yeah, I guess." But this time next year, if you haven't vaccinated, people are gonna come to your house and board it up and make you stay inside.
KIRA: Well, given how much we're so dependent on these vaccines to get us back to a regular life, I can understand the sentiment. What is your take on the big controversy right now, just going back towards the present day a little bit more on having kids in schools. Is that something you support before all the teachers have been vaccinated?
DR. CAPLAN: I do, but I have a problem with the definition of a teacher and a school. So by the way, some people that I know, friends of mine have said, "Well, I'm a teacher, I'm a yoga instructor. I'm a teacher, I'm an aerobics instructor. So I should get priority access to vaccination." I don't think that's what we meant by teacher. And here's the difference in schools. I live in Ridgefield, Connecticut. Up the street for me is a very fancy private elementary school. It has endless grounds, open classrooms. If there are eight kids in a class, I'll pass out. It is great. I wish I went to college there. It's a wonderful set up. Do they need to vaccinate everybody? Probably not, they're all sitting six feet apart, everybody in there is gonna mask, they have huge auditoriums. They never have to come in contact.
I've been in some other schools in the Bronx. No ventilation, no plumbing, 35 kids in a class, the teacher's 65. And you sort of think, "Boy, I'd wanna have vaccinate everybody in sight in this place because unless we re-haul the buildings and downsize the class size, people are gonna get sick in here."
They probably were getting sick anyway before COVID, but now COVID makes it worse. They're probably getting the flu or colds at nine times the rate that they were in Ridgefield, Connecticut. So my point is this, high school kids doing certain things, they can come in on a mixed schedule three days a week, two days a week, do their thing, they know how to mask. Am I worried about vaccinating there? Not too much. Elementary school kids need psychosocial development, need to learn social skills, sometimes going to schools that aren't that wonderful. Yeah, let's vaccinate them. So even though I was complaining a bit about micro-management and trying to parse out, here I think you need to do it. I think you're probably gonna say college, I don't know that you have to vaccinate there. High schools, 50/50. Elementary school, let's do them first.
KIRA: Got it. And one more question on kids before I wanna move on, there's been talk about whether it's necessary before kids are allowed to get this vaccine to have the FDA go to full approval with the full bulk of data necessary for that versus just an emergency authorization for the general population, given that kids are at so much lower risk than adults. But then of course, it'll take a lot more time, I imagine, to get the kids the vaccines. What's your take on that?
DR. CAPLAN: We historically have demanded higher levels of evidence to do anything with a kid, and I think that's gonna hold true here too. I don't think you're gonna see emergency-use authorization for people under 18. Maybe they'd cut it and say, "We'll do it 12-18," but just looking at the history of drug development, vaccine development, people are really leery of taking risks with kids and appropriately so. Kids can't even make their own decision. I can decide if I wanna take an emergency-use vaccine, if I think it's too iffy I don't take it right now. So up to me to weigh the risk-benefit. I don't think so. I think you'll see licensing required before we really get it, at least 12 and under. Let's put it there. And I'm not worried about the safety or efficacy of these things in kids. I think there's no reason, given the biological mechanisms, to think they're gonna be any different. But it's gonna be pretty tough pre-licensure to impose anything.
KIRA: And when do you think that licensure for kids under 12 could come?
DR. CAPLAN: Well, two groups of people are now being studied, pregnant women, the studies just launched. They'll probably be done sufficiently by the end of the year. Kids for full licensure, spring next year.
KIRA: Okay. And because this is a big question for a lot of women that I know and women in general who are pregnant, what would you say to them now, where we don't have the data yet on the safety, but they have to decide and they can't wait six or nine more months?
DR. CAPLAN: Vaccinate yesterday. Literally, I think the COVID virus is too dangerous, I think it's dangerous to the mom, I think it's dangerous to the fetus. It is an unknown, but boy, I would bet on the vaccine more than I would taking my chances with the virus.
KIRA: Got it. So let's pivot a little bit and talk about some of the big open questions around the vaccines that we're starting to get some early evidence about. For one thing, do they prevent transmission and not just symptomatic disease. And I think it's worth pointing out for our audience here that there is a big difference between preventing symptoms and preventing infections, as lots of asymptomatic people know. And we have a lot of new real-world evidence from Israel, from Scotland, reporting that even asymptomatic infections are greatly reduced by the Pfizer vaccine, for example. What is your take on how this new data is going to change guidance around post-vaccination behaviors?
DR. CAPLAN: Yeah. What do we got in the podcast? Seven or eight hours to go? That's a tough one. It's complicated. But trying to over-simplify a little bit. So there is a difference, and this has gotten confusing, I fear. Some vaccines prevent you from getting infected at all. It looks like the Pfizer and the Moderna fall into that category. That's great, 'cause no matter what else, it probably means you're gonna reduce transmission, 'cause if you can't be infected, I don't know how you're gonna give it to somebody else. So I'll bet that that's a transmission reduction. Looks like Johnson & Johnson, unclear. Seems to prevent bad symptoms and death but not moderate disease, and it isn't clear that it stops you from getting infected. So that may become an issue in terms of how we strategically approach when we have enough vaccine of the different types. We may wanna say, "Look, in some environments, we've gotta control spread... Nursing home. We wanna see the Moderna there. We wanna see the Pfizer there."
In other situations, we just wanna make sure you're not dead, let's get the Janssen thing out there. And that'll be great. I'll tell you... I'll give you an example from my own current existence. So I've been pretty cautious... As I said, I live in Ridgefield, Connecticut. I have a house, pretty roomy, but I haven't left it very often. I'm willing to take the chance to go shopping. I'll confess I'm even willing to take the chance wearing a mask to go to the drug store and I've had a hair-cut or two. So I've been not hyper-cautious, but cautious. I don't invite people over that I don't know where they've been, so to speak. But now I'm vaccinated, and my wife is fully vaccinated. And the other night for the first time, we went out to an indoor restaurant. Probably haven't done that in 10 months... No, I don't know, six months. But a long time...
KIRA: I hope you really enjoyed that first meal out, 'cause that's something that I dream about. Boy, where am I gonna go and what am I gonna order?
DR. CAPLAN: Yeah. We went to the fanciest restaurant in town, as a matter of fact, and they were social distancing and everybody was masked and the wait staff. But I figure, good enough for me. If the thing isn't gonna kill me, if I was just told I was gonna have a risk of being sick for three days or something, that's good enough for me. I don't wanna infect somebody else. So I'll still mask and do that, I'm not sure. But I'm absolutely ready to say, and in fact, I've scheduled two trips. We're gonna take a trip to Florida, we're gonna take a trip to North Carolina in March and April. I'm figuring even then, things will be better. But everybody's gonna have choices like that to make. It'll be really interesting. If I'm Tony Fauci or one of our big public health guys, I don't want anybody going anywhere, I'm risk-averse, until maybe 2027. I think it'll be controlled and eliminated... We'll have lots of data and everything will be great. I'm a little bit more, shall we say, individual choice-oriented, making individual risk things, like I said. As long as I'm responsible to others.
I don't wanna make anybody else sick, but if I am ready to take the chance of just being sick for a few days, and I believe the vaccines available will keep me out of the hospital and keep me out of the Morticians building. Okay, I'm ready to do it. So each one of us is gonna have to make a value decision, this is what I find interesting, about what's normal. It isn't science. It isn't medicine. It's ethics. You're gonna have to decide how much risk do you wanna take. Do you wanna be a jerk to your neighbor, if you could still have a teeny chance of infecting them? Am I willing to live in a world where COVID is around but it's kinda rare? I know kids are still transmitting, but it's not really a huge risk. That's the kind of value choice that each of us will be faced with.
KIRA: I really appreciate your emphasis on individual choice and values here and letting... Basically allowing people to make those judgments based on their circumstances for themselves. If you're not deathly afraid of getting a mild cold-type illness, then I can understand why you wanna fly or go to a restaurant, and other people might not be comfortable with any risk at all, and they're perfectly welcome to stay home.
DR. CAPLAN: Or they may say, "I'm 80, I have nine chronic diseases. A mild illness still freaks me out." Okay, I get that. I'm perfectly respectful of that. It's interesting. I think we've been used to public health messaging, and people have this attitude that at some point, Fauci or the head of the CDC, somebody's gonna show up on TV and say, "All clear, everything's over, back to normal, we've declared victory over the enemy. It's armistice day." Whatever. It isn't gonna work like that is my prediction. It's gonna be a slow creep, different people deciding, "I'm safe enough, I'm wandering out." Other people say, "No, no, not ready." Or somebody saying, "I'm pregnant. I'm staying in. I don't care what's going on. I'm not gonna take that risk." I think people will be surprised that there isn't going to be a national day of resolution or something. [chuckle]
KIRA: Right. It's more about these individual behaviors and over time, letting people decide what to do. So for example, if you had grandkids and they were not vaccinated, but you are, would you hug them, would you get close to them, how would you behave and how do you think they should behave around you?
DR. CAPLAN: So I'd be still nervous about them transmitting, but I'm also a very strong believer in my vaccine. So yes, I would hug them, and yes, I would have them come to visit. And that's probably gonna happen actually fairly soon. But their parents aren't vaccinated yet. And so I'm still nervous that maybe better not to do a lot of social mingling right now. But yeah, people have said to me, "My grandmom is 94. I don't know how long she's gonna be here. You think if I'm vaccinated it's okay to pay a visit." I'm gonna start to say, "Yeah, I get that."
KIRA: And I think one thing that's lost in these discussions of safety is also the aspect of benefits to human life and why we even live in the first place. We don't live lives of complete safety. We drive, we fly, we do things that are risky, but we take those risks, because it's worth it. So I think that should be part of the discussion overall, not just safety, period.
DR. CAPLAN: And not just saving lives. So ski slopes, there are a lot of orthopedic clinics at the bottom of big ski slopes, and sending a message like, "You can break bones here." But people say, "I wanna do it, I enjoy it." Okay, I'm not sure all the time that we should factor all of that into our pooled insurance plan, but that's a fight for another day. Nonetheless, I would... You know something, I would pay for it 'cause I like to encourage people to enjoy themselves. So I have my bad habits, they have their bad habits. I think it's sort of a wash in a certain way. But more to your point, I think if you look out there and say, there are some areas where we don't let you choose. You must put your kid in a car seat. A kid can't make a decision, the thing is very effective, really saves their lives, they should have a life ahead of them, and we're gonna force it. And I'm all for that.
In other instances, I might go into the restaurant. I think it's part of the general, "Am I gonna drive a car, am I gonna cross a busy street... " As you said, there are many things I have to do where I have to think about the risk-benefit. I may make a lousy calculation and underestimate what it means to get in my car and drive in terms of risk relative to getting hit by lightening or some other risks, but that's a little bit more for me.
KIRA: So that's a really thought-provoking conversation, but I wanna switch for a minute to another question mark around the vaccines besides transmission, is the long-term studies of their effects on the immune system. And one thing that I've noticed some experts are concerned about is the fact that a lot of the people in the placebo groups have dropped out of the trials and gotten the vaccine because ethically you can't withhold the vaccinations from these volunteers, but at the same time, that could be hurting our ability to compare the vaccine's long-term effects against people who haven't had the vaccine for a long time. So how significant is this issue in your mind?
DR. CAPLAN: Big. Some people actually proposed that we not let them drop out, we not tell the subjects in these big trials of vaccines if they were in the placebo group. Can't do that. It's clearly unethical... Achieved consensus on that decades ago, with various studies where the researcher said, "We don't have to tell the subjects that there's a treatment." Tuskegee did that, for example, the horrible study in the early, late '60s, early '70s, where they didn't tell people there was a cure and kept the study going of venereal disease, but there have been many others since. We already know you gotta give them the option. Some people may stay in anyway, but not enough to allow the study to really have integrity. So I think current studies are likely to fall apart and we won't get answers in the way we're used to with randomized trials to the long-term effects or even to the how long does it last question.
We need to build a system that can follow people. We can't rely on them being in an observed clinical trial. We have to start to say, "You register, we're gonna check on you every year to see how you're doing." That's gotta be done. And one other provocative idea, I pushed it long ago, challenge studies. Deliberately infect a small group of people, hopefully healthy people that choose to do it with mild COVID and then see what the vaccine does in them and then get an answer faster if you study them over time, they volunteered knowingly to get exposed this way. I think you're gonna see some challenge studies done particularly to compare vaccines. There are still more vaccines coming, maybe some of them will last longer, cheaper, safer, I don't know. The only way you're gonna study the next round of vaccines is in a challenge study. You're never getting anybody to sign up to be in a placebo control randomized trial.
KIRA: So that was actually my next question, that the UK just approved the first ever challenge study to infect the volunteers on purpose with the virus. Now, the UK has often been much more progressive in doing medical research than the US. Do you think the US will ever get to that point or are we just gonna rely on other countries to do that for us?
DR. CAPLAN: I think we won't get there. We're so conservative, so litigation conscious. People are freaked out that if somebody got sick and died in a challenge study, it would bankrupt the sponsor. I think the UK is on the right path, but I don't really think we're gonna follow.
KIRA: Okay, well, I hope that they can do the work that we really need. And I'm grateful that there are other countries that are more permissive of risk-taking and doing the controversial studies that are required.
DR. CAPLAN: Ironically, if you don't do the challenge studies, the only other way you're gonna get to do big-scale randomized placebo trials is in the poorest countries that can't get anything. And that makes it an awful lot like exploitation, taking advantage, as opposed to choice. But that's where you'd go, you'd say, "Oh, I got this new vaccine, I'll test it out in Sierra Leone and they don't have anything anyway. So better that half of them get the vaccine than not." And I still think the challenge study makes more ethic sense.
KIRA: Yeah, absolutely. That would really be a shame to be put in that position instead of just allowing people to decide. We let people sign up for the army where they might die. What's the ethical difference with signing up for a potentially dangerous study, but if you're young and healthy, the risk is low?
DR. CAPLAN: By the way, the risk from COVID to say, 18 to 35-year-olds, who's who you'd be looking at, is about the same as donating a kidney, which we also allow all the time.
KIRA: Right, right. Great point. Before we finish up here, I just wanna quickly touch on, of course, the big elephant in the room, which we all have to deal with, unfortunately, which is the variants. So I wanna talk about where we stand. I've heard some vaccine experts recently say, like Paul Offit, for example, has said he doesn't expect a fourth surge due to this, but others are more cautious and take the flip side saying, "This is the calm before the storm. We're about to see another huge explosion." California has recently reported a new strain as accounts for maybe potentially 50% of cases now, and it could be 90% by the end of March. But we're seeing such big declines in the numbers in hospitalizations, in cases. So what should people make of these conflicting messages?
DR. CAPLAN: There's an attitude in medicine that many doctors take toward things like incipient or new prostate cancer, sometimes toward breast cancer, or at least lumps. It's called watchful waiting. You pay attention. You watch what's going on. But you don't do anything right away. I would still get vaccinated, I would still take what I could get. I still believe that it's likely that these vaccines are gonna provide some protection, if not against infection, then at least against the worst symptoms and the worst chances of dying because they're really gonna boost up the basic immune system, which should be able to start to fight against viruses.
That said, could we wind up with some virulent new strain that evades the current vaccine platforms? Yes. Is it likely? I don't think so. But what it does mean is get ready to get boosters because the response to new strains that have been a result of viral mutations is you gotta adjust your vaccine. That's what we'll do. I hope it doesn't send us back into quarantine and isolation and distancing and all the rest of it as our only control. I'm hoping that the manufacturers can roll out boosters more quickly than the first round of vaccines.
KIRA: And the FDA has just said that the vaccine developers will not need to start over with new clinical trials to these boosters. So that will greatly expedite the process. And do you think that's the right call?
DR. CAPLAN: Yes, absolutely. You're not changing the fundamental nature of the vaccine platform, you're just tweaking, if you will, which chemistry responds to the virus. So yeah, I do.
KIRA: And one question then that necessarily everyone is gonna wonder is, "Well, if I got the J&J vaccine, can I get an mRNA booster?" Can you mix and match? Is that gonna work for your immune system?
DR. CAPLAN: Yeah. We don't have any idea. And I wouldn't do that right away. I know some countries are thinking about that to get more, if you will, use out of a limited supply. I'd say wait three months and do it the right way, where the data is in evidence. I'm not worried about people getting a second shot of something different and dropping dead. I'm just worried that it won't work. [chuckle] So I'm not a fan of mix and match. You can do it in some studies, by the way. You could do it in some challenge studies and get a faster answer than you would having to try and do this in 30,000 people over a year. But no, I don't think that's a good way to go. And I'm not a big fan of one-shot strategies either. I think, what we know is that the second shot really kicks your immune system into high gear and that's what you want for real protection. So I know why people say it but I wouldn't advocate for it.
KIRA: Right. And for my last question. One of our big themes this year that we'll be following all throughout the year at leaps.org is our progress towards an eventual return to life and return to normalcy. So I have to ask that question to you. Given everything that you know and that we've discussed today, when do you think our lives and society will start to look normal again, with schools, and restaurants, and businesses open, people are flying and gathering without fear, traveling, etcetera?
DR. CAPLAN: I think you're gonna see a lot of that this summer. There's gonna be enough vaccine out there, even if the epidemiologists aren't 100% happy. As I said, I think a lot of people are gonna say, "I'm happy enough, good enough for me. I'm going to sports and I'm flying, and I'm taking a vacation." And we'll be outside again. Remember we had the ability to eat outdoors and congregate less when the weather's better around the whole country, and I think that will open up Europe and the US in addition. What I'm worried about is if we had to go back in the fall to a more controlled environment, either 'cause a new strain appeared, or just because things weren't as efficacious as we hoped they'd be. But I think summer is gonna be good this year.
KIRA: Well, I hope you're right. I hope your crystal ball is working today. [chuckle]
DR. CAPLAN: [chuckle] And if it's not working right, email Kira. Don't talk to me.
KIRA: Yeah, I cannot be held liable for this. Thank you Art for a fascinating discussion. And thanks to everyone for listening. If you like this show, follow Making Sense of Science to hear new episodes coming once a month. And if you wanna give us feedback, we'd love to hear from you. Get in touch on our website, leaps.org. And until next time, thanks everyone.
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.
Earlier this year, Harvard scientists reported that they used an anti-aging therapy to reverse blindness in elderly mice. Several other studies in the past decade have suggested that the aging process can be modified, at least in lab organisms. Considering mice and humans share virtually the same genetic makeup, what does the rodent-based study mean for the humans?
In truth, we don’t know. Maybe nothing.
What we do know, however, is that a growing number of people are dedicating themselves to defying the aging process, to turning back the clock – the biological clock, that is. Take Bryan Johnson, a man who is less mouse than human guinea pig. A very wealthy guinea pig.
The 45-year-old venture capitalist spends over $2 million per year reversing his biological clock. To do this, he employs a team of 30 medical doctors and other scientists. His goal is to eventually reset his biological clock to age 18, and “have all of his major organs — including his brain, liver, kidneys, teeth, skin, hair, penis and rectum — functioning as they were in his late teens,” according to a story earlier this year in the New York Post.
But his daily routine paints a picture that is far from appealing: for example, rigorously adhering to a sleep schedule of 8 p.m. to 5 a.m. and consuming more than 100 pills and precisely 1,977 calories daily. Considering all of Johnson’s sacrifices, one discovers a paradox:
To live forever, he must die a little every day until he reaches his goal - if he ever reaches his goal.
Less extreme examples seem more helpful for people interested in happy, healthy aging. Enter Chris Mirabile, a New Yorker who says on his website, SlowMyAge.com, that he successfully reversed his biological age by 13.6 years, from the chronological age of 37.2 to a biological age of 23.6. To put this achievement in perspective, Johnson, to date, has reversed his biological clock by 2.5 years.
Mirabile's habits and overall quest to turn back the clock trace back to a harrowing experience at age 16 during a school trip to Manhattan, when he woke up on the floor with his shirt soaked in blood.
Mirabile, who is now 38, supports his claim with blood tests that purport to measure biological age by assessing changes to a person’s epigenome, or the chemical marks that affect how genes are expressed. Mirabile’s tests have been run and verified independently by the same scientific lab that analyzes Johnson’s. (In an email to Leaps.org, the lab, TruDiagnostic, confirmed Mirabile’s claims about his test results.)
There is considerable uncertainty among scientists about the extent to which these tests can accurately measure biological age in individuals. Even so, Mirabile’s results are intriguing. They could reflect his smart lifestyle for healthy aging.
His habits and overall quest to turn back the clock trace back to a harrowing experience at age 16 during a school trip to Manhattan, when Mirabile woke up on the floor with his shirt soaked in blood. He’d severed his tongue after a seizure. He later learned it was caused by a tumor the size of a golf ball. As a result, “I found myself contemplating my life, what I had yet to experience, and mortality – a theme that stuck with me during my year of recovery and beyond,” Mirabile told me.
For the next 15 years, he researched health and biology, integrating his learnings into his lifestyle. Then, in his early 30s, he came across an article in the journal Cell, "The Hallmarks of Aging," that outlined nine mechanisms of the body that define the aging process. Although the paper says there are no known interventions to delay some of these mechanisms, others, such as inflammation, struck Mirabile as actionable. Reading the paper was his “moment of epiphany” when it came to the areas where he could assert control to maximize his longevity.
He also wanted “to create a resource that my family, friends, and community could benefit from in the short term,” he said. He turned this knowledge base into a company called NOVOS dedicated to extending lifespan.
His longevity advice is more accessible than Johnson’s multi-million dollar approach, as Mirabile spends a fraction of that amount. Mirabile takes one epigenetic test per year and has a gym membership at $45 per month. Unlike Johnson, who takes 100 pills per day, Mirabile takes 10, costing another $45 monthly, including a B-complex, fish oil, Vitamins D3 and K2, and two different multivitamin supplements.
Mirabile’s methods may be easier to apply in other ways as well, since they include activities that many people enjoy anyway. He’s passionate about outdoor activities, travels frequently, and has loving relationships with friends and family, including his girlfriend and collie.
Here are a few of daily routines that could, he thinks, contribute to his impressively young bio age:
After waking at 7:45 am, he immediately drinks 16 ounces of water, with 1/4 teaspoon of sodium and potassium to replenish electrolytes. He takes his morning vitamins, brushes and flosses his teeth, puts on a facial moisturizing sunblock and goes for a brisk, two-mile walk in the sun. At 8:30 am on Mondays, Wednesdays, and Fridays he lift weights, focusing on strength and power, especially in large muscle groups.
Tuesdays, Thursdays and Saturdays are intense cardio days. He runs 5-7 miles or bicycles for 60 minutes first thing in the morning at a brisk pace, listening to podcasts. Sunday morning cardio is more leisurely.
After working out each day, he’s back home at 9:20 am, where he makes black coffee, showers, then applies serum and moisturizing sunblock to his face. He works for about three hours on his laptop, then has a protein shake and fruit.
Mirabile is a dedicated intermittent faster, with a six hour eating window in between 18 hours fasts. At 3 pm, he has lunch. The Mediterranean lineup often features salmon, sardines, olive oil, pink Himalayan salt plus potassium salt for balance, and lots of dried herbs and spices. He almost always finishes with 1/3 to 1/2 bar of dark chocolate.
If you are what you eat, Mirabile is made of mostly plants and lean meats. He follows a Mediterranean diet full of vegetables, fruits, fatty fish and other meats full of protein and unsaturated fats. “These may cost more than a meal at an American fast-food joint, but then again, not by much,” he said. Each day, he spends $25 on all his meals combined.
At 6 pm, he takes the dog out for a two-mile walk, taking calls for work or from family members along the way. At 7 pm, he dines with his girlfriend. Like lunch, this meal is heavy on widely available ingredients, including fish, fresh garlic, and fermented food like kimchi. Mirabile finishes this meal with sweets, like coconut milk yogurt with cinnamon and clove, some stevia, a mix of fresh berries and cacao nibs.
If Mirabile's epigenetic tests are accurate, his young biological age could be thanks to his healthy lifestyle, or it could come from a stroke of luck if he inherited genes that protect against aging.
At 8 pm, he wraps up work duties and watches shows with his girlfriend, applies serum and moisturizer yet again, and then meditates with the lights off. This wind-down, he said, improves his sleep quality. Wearing a sleep mask and earplugs, he’s asleep by about 10:30.
“I’ve achieved stellar health outcomes, even after having had the physiological stressors of a brain tumor, without spending a fortune,” Mirabile said. “In fact, even during times when I wasn’t making much money as a startup founder with few savings, I still managed to live a very healthy, pro-longevity lifestyle on a modest budget.”
Mirabile said living a cleaner, healthier existence is a reality that many readers can achieve. It’s certainly true that many people live in food deserts and have limited time for exercise or no access to gyms, but James R. Doty, a clinical professor of neurosurgery at Stanford, thinks many can take more action to stack the odds that they’ll “be happy and live longer.” Many of his recommendations echo aspects of Mirabile’s lifestyle.
Each night, Doty said, it’s vital to get anywhere between 6-8 hours of good quality sleep. Those who sleep less than 6 hours per night are at an increased risk of developing a whole host of medical problems, including high blood pressure, type 2 diabetes, and stroke.
In addition, it’s critical to follow Mirabile’s prescription of exercise for about one hour each day, and intensity levels matter. Doty noted that, in 2017, researchers at Brigham Young University found that people who ran at a fast pace for 30-40 minutes five days per week were, on average, biologically younger by nine years, compared to those who subscribed to more moderate exercise programs, as well as those who rarely exercised.
When it comes to nutrition, one should consider fasting for 16 hours per day, Doty said. This is known as the 16/8 method, where one’s daily calories are consumed within an eight hour window, fasting for the remaining 16 hours, just like Mirabile. Intermittent fasting is associated with cellular repair and less inflammation, though it’s not for everyone, Doty added. Consult with a medical professional before trying a fasting regimen.
Finally, Doty advised to “avoid anger, avoid stress.” Easier said than done, but not impossible. “Between stimulus and response, there is a pause and within that pause lies your freedom,” Doty said. Mirabile’s daily meditation ritual could be key to lower stress for healthy aging. Research has linked regular, long-term meditation to having a lower epigenetic age, compared to control groups.
Many other factors could apply. Having a life purpose, as Mirabile does with his company, has also been associated with healthy aging and lower epigenetic age. Of course, Mirabile is just one person, so it’s hard to know how his experience will apply to others. If his tests are accurate, his young biological age could be thanks to his healthy lifestyle, or it could come from a stroke of luck if he inherited genes that protect against aging. Clearly, though, any such genes did not protect him from cancer at an early age.
The third and perhaps most likely explanation: Mirabile’s very young biological age results from a combination of these factors. Some research shows that genetics account for only 25 percent of longevity. That means environmental factors could be driving the other 75 percent, such as where you live, frequency of exercise, quality of nutrition and social support.
The middle-aged – even Brian Johnson – probably can’t ever be 18 again. But more modest goals are reasonable for many. Control what you can for a longer, healthier life.
FDA, researchers work to make clinical trials more diverse
Nestled in a predominately Hispanic neighborhood, a new mural outside Guadalupe Centers Middle School in Kansas City, Missouri imparts a powerful message: “Clinical Research Needs Representation.” The colorful portraits painted above those words feature four cancer survivors of different racial and ethnic backgrounds. Two individuals identify as Hispanic, one as African American and another as Native American.
One of the patients depicted in the mural is Kim Jones, a 51-year-old African American breast cancer survivor since 2012. She advocated for an African American friend who participated in several clinical trials for ovarian cancer. Her friend was diagnosed in an advanced stage at age 26 but lived nine more years, thanks to the trials testing new therapeutics. “They are definitely giving people a longer, extended life and a better quality of life,” said Jones, who owns a nail salon. And that’s the message the mural aims to send to the community: Clinical trials need diverse participants.
While racial and ethnic minority groups represent almost half of the U.S. population, the lack of diversity in clinical trials poses serious challenges. Limited awareness and access impede equitable representation, which is necessary to prove the safety and effectiveness of medical interventions across different groups.
A Yale University study on clinical trial diversity published last year in BMJ Medicine found that while 81 percent of trials testing the new cancer drugs approved by the U.S. Food and Drug Administration between 2012 and 2017 included women, only 23 percent included older adults and 5 percent fairly included racial and ethnic minorities. “It’s both a public health and social justice issue,” said Jennifer E. Miller, an associate professor of medicine at Yale School of Medicine. “We need to know how medicines and vaccines work for all clinically distinct groups, not just healthy young White males.” A recent JAMA Oncology editorial stresses out the need for legislation that would require diversity action plans for certain types of trials.
Ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health.--FDA Commissioner Robert M. Califf.
But change is on the horizon. Last April, the FDA issued a new draft guidance encouraging industry to find ways to revamp recruitment into clinical trials. The announcement, which expanded on previous efforts, called for including more participants from underrepresented racial and ethnic segments of the population.
“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” FDA commissioner Robert M. Califf, a physician, said in a statement. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities. This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics and clinical trials.”
Lola Fashoyin-Aje, associate director for Science and Policy to Address Disparities in the Oncology Center of Excellence at the FDA, said that the agency “has long held the view that clinical trial participants should reflect the clinical and demographic characteristics of the patients who will ultimately receive the drug once approved.” However, “numerous studies over many decades” have measured the extent of underrepresentation. One FDA analysis found that the proportion of White patients enrolled in U.S. clinical trials (88 percent) is much higher than their numbers in country's population. Meanwhile, the enrollment of African American and Native Hawaiian/American Indian and Alaskan Native patients is below their national numbers.
The FDA’s guidance is accelerating researchers’ efforts to be more inclusive of diverse groups in clinical trials, said Joyce Sackey, a clinical professor of medicine and associate dean at Stanford School of Medicine. Underrepresentation is “a huge issue,” she noted. Sackey is focusing on this in her role as the inaugural chief equity, diversity and inclusion officer at Stanford Medicine, which encompasses the medical school and two hospitals.
Until the early 1990s, Sackey pointed out, clinical trials were based on research that mainly included men, as investigators were concerned that women could become pregnant, which would affect the results. This has led to some unfortunate consequences, such as indications and dosages for drugs that cause more side effects in women due to biological differences. “We’ve made some progress in including women, but we have a long way to go in including people of different ethnic and racial groups,” she said.
A new mural outside Guadalupe Centers Middle School in Kansas City, Missouri, advocates for increasing diversity in clinical trials. Kim Jones, 51-year-old African American breast cancer survivor, is second on the left.
Artwork by Vania Soto. Photo by Megan Peters.
Among racial and ethnic minorities, distrust of clinical trials is deeply rooted in a history of medical racism. A prime example is the Tuskegee Study, a syphilis research experiment that started in 1932 and spanned 40 years, involving hundreds of Black men with low incomes without their informed consent. They were lured with inducements of free meals, health care and burial stipends to participate in the study undertaken by the U.S. Public Health Service and the Tuskegee Institute in Alabama.
By 1947, scientists had figured out that they could provide penicillin to help patients with syphilis, but leaders of the Tuskegee research failed to offer penicillin to their participants throughout the rest of the study, which lasted until 1972.
Opeyemi Olabisi, an assistant professor of medicine at Duke University Medical Center, aims to increase the participation of African Americans in clinical research. As a nephrologist and researcher, he is the principal investigator of a clinical trial focusing on the high rate of kidney disease fueled by two genetic variants of the apolipoprotein L1 (APOL1) gene in people of recent African ancestry. Individuals of this background are four times more likely to develop kidney failure than European Americans, with these two variants accounting for much of the excess risk, Olabisi noted.
The trial is part of an initiative, CARE and JUSTICE for APOL1-Mediated Kidney Disease, through which Olabisi hopes to diversify study participants. “We seek ways to engage African Americans by meeting folks in the community, providing accessible information and addressing structural hindrances that prevent them from participating in clinical trials,” Olabisi said. The researchers go to churches and community organizations to enroll people who do not visit academic medical centers, which typically lead clinical trials. Since last fall, the initiative has screened more than 250 African Americans in North Carolina for the genetic variants, he said.
Other key efforts are underway. “Breaking down barriers, including addressing access, awareness, discrimination and racism, and workforce diversity, are pivotal to increasing clinical trial participation in racial and ethnic minority groups,” said Joshua J. Joseph, assistant professor of medicine at the Ohio State University Wexner Medical Center. Along with the university’s colleges of medicine and nursing, researchers at the medical center partnered with the African American Male Wellness Agency, Genentech and Pfizer to host webinars soliciting solutions from almost 450 community members, civic representatives, health care providers, government organizations and biotechnology professionals in 25 states and five countries.
Their findings, published in February in the journal PLOS One, suggested that including incentives or compensation as part of the research budget at the institutional level may help resolve some issues that hinder racial and ethnic minorities from participating in clinical trials. Compared to other groups, more Blacks and Hispanics have jobs in service, production and transportation, the authors note. It can be difficult to get paid leave in these sectors, so employees often can’t join clinical trials during regular business hours. If more leaders of trials offer money for participating, that could make a difference.
Obstacles include geographic access, language and other communications issues, limited awareness of research options, cost and lack of trust.
Christopher Corsico, senior vice president of development at GSK, formerly GlaxoSmithKline, said the pharmaceutical company conducted a 17-year retrospective study on U.S. clinical trial diversity. “We are using epidemiology and patients most impacted by a particular disease as the foundation for all our enrollment guidance, including study diversity plans,” Corsico said. “We are also sharing our results and ideas across the pharmaceutical industry.”
Judy Sewards, vice president and head of clinical trial experience at Pfizer’s headquarters in New York, said the company has committed to achieving racially and ethnically diverse participation at or above U.S. census or disease prevalence levels (as appropriate) in all trials. “Today, barriers to clinical trial participation persist,” Sewards said. She noted that these obstacles include geographic access, language and other communications issues, limited awareness of research options, cost and lack of trust. “Addressing these challenges takes a village. All stakeholders must come together and work collaboratively to increase diversity in clinical trials.”
It takes a village indeed. Hope Krebill, executive director of the Masonic Cancer Alliance, the outreach network of the University of Kansas Cancer Center in Kansas City, which commissioned the mural, understood that well. So her team actively worked with their metaphorical “village.” “We partnered with the community to understand their concerns, knowledge and attitudes toward clinical trials and research,” said Krebill. “With that information, we created a clinical trials video and a social media campaign, and finally, the mural to encourage people to consider clinical trials as an option for care.”
Besides its encouraging imagery, the mural will also be informational. It will include a QR code that viewers can scan to find relevant clinical trials in their location, said Vania Soto, a Mexican artist who completed the rendition in late February. “I’m so honored to paint people that are survivors and are living proof that clinical trials worked for them,” she said.
Jones, the cancer survivor depicted in the mural, hopes the image will prompt people to feel more open to partaking in clinical trials. “Hopefully, it will encourage people to inquire about what they can do — how they can participate,” she said.