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.
Opioid prescription policies may hurt those in chronic pain
Tinu Abayomi-Paul works as a writer and activist, plus one unwanted job: Trying to fill her opioid prescription. She says that some pharmacists laugh and tell her that no one needs the amount of pain medication that she is seeking. Another pharmacist near her home in Venus, Tex., refused to fill more than seven days of a 30-day prescription.
To get a new prescription—partially filled opioid prescriptions can’t be dispensed later—Abayomi-Paul needed to return to her doctor’s office. But without her medication, she was having too much pain to travel there, much less return to the pharmacy. She rationed out the pills over several weeks, an agonizing compromise that left her unable to work, interact with her children, sleep restfully, or leave the house. “Don’t I deserve to do more than survive?” she says.
Abayomi-Paul’s pain results from a degenerative spine disorder, chronic lymphocytic leukemia, and more than a dozen other diagnoses and disabilities. She is part of a growing group of people with chronic pain who have been negatively impacted by the fallout from efforts to prevent opioid overdose deaths.
Guidelines for dispensing these pills are complicated because many opioids, like codeine, oxycodone, and morphine, are prescribed legally for pain. Yet, deaths from opioids have increased rapidly since 1999 and become a national emergency. Many of them, such as heroin, are used illegally. The CDC identified three surges in opioid use: an increase in opioid prescriptions in the ‘90s, a surge of heroin around 2010, and an influx of fentanyl and other powerful synthetic opioids in 2013.
As overdose deaths grew, so did public calls to address them, prompting the CDC to change its prescription guidelines in 2016. The new guidelines suggested limiting medication for acute pain to a seven-day supply, capping daily doses of morphine, and other restrictions. Some statistics suggest that these policies have worked; from 2016 to 2019, prescriptions for opiates fell 44 percent. Physicians also started progressively lowering opioid doses for patients, a practice called tapering. A study tracking nearly 100,000 Medicare subscribers on opioids found that about 13 percent of patients were tapering in 2012, and that number increased to about 23 percent by 2017.
But some physicians may be too aggressive with this tapering strategy. About one in four people had doses reduced by more than 10 percent per week, a rate faster than the CDC recommends. The approach left people like Abayomi-Paul without the medication they needed. Every year, Abayomi-Paul says, her prescriptions are harder to fill. David Brushwood, a pharmacy professor who specializes in policy and outcomes at the University of Florida in Gainesville, says opioid dosing isn’t one-size-fits-all. “Patients need to be taken care of individually, not based on what some government agency says they need,” he says.
‘This is not survivable’
Health policy and disability rights attorney Erin Gilmer advocated for people with pain, using her own experience with chronic pain and a host of medical conditions as a guidepost. She launched an advocacy website, Healthcare as a Human Right, and shared her struggles on Twitter: “This pain is more than anything I've endured before and I've already been through too much. Yet because it's not simply identified no one believes it's as bad as it is. This is not survivable.”
When her pain dramatically worsened midway through 2021, Gilmer’s posts grew ominous: “I keep thinking it can't possibly get worse but somehow every day is worse than the last.”
The CDC revised its guidelines in 2022 after criticisms that people with chronic pain were being undertreated, enduring dangerous withdrawal symptoms, and suffering psychological distress. (Long-term opioid use can cause physical dependency, an adaptive reaction that is different than the compulsive misuse associated with a substance use disorder.) It was too late for Gilmer. On July 7, 2021, the 38-year-old died by suicide.
Last August, an Ohio district court ruling set forth a new requirement for Walgreens, Walmart, and CVS pharmacists in two counties. These pharmacists must now document opioid prescriptions that are turned down, even for customers who have no previous purchases at that pharmacy, and they’re required to share this information with other locations in the same chain. None of the three pharmacies responded to an interview request from Leaps.org.
In a practice called red flagging, pharmacists may label a prescription suspicious for a variety of reasons, such as if a pharmacist observes an unusually high dose, a long distance from the patient’s home to the pharmacy, or cash payment. Pharmacists may question patients or prescribers to resolve red flags but, regardless of the explanation, they’re free to refuse to fill a prescription.
As the risk of litigation has grown, so has finger-pointing, says Seth Whitelaw, a compliance consultant at Whitelaw Compliance Group in West Chester, PA, who advises drug, medical device, and biotech companies. Drugmakers accused in National Prescription Opioid Litigation (NPOL), a complex set of thousands of cases on opioid epidemic deaths, which includes the Ohio district case, have argued that they shouldn’t be responsible for the large supply of opiates and overdose deaths. Yet, prosecutors alleged that these pharmaceutical companies hid addiction and overdose risks when labeling opioids, while distributors and pharmacists failed to identify suspicious orders or scripts.
Patients and pharmacists fear red flags
The requirements that pharmacists document prescriptions they refuse to fill so far only apply to two counties in Ohio. But Brushwood fears they will spread because of this precedent, and because there’s no way for pharmacists to predict what new legislation is on the way. “There is no definition of a red flag, there are no lists of red flags. There is no instruction on what to do when a red flag is detected. There’s no guidance on how to document red flags. It is a standardless responsibility,” Brushwood says. This adds trepidation for pharmacists—and more hoops to jump through for patients.
“I went into the doctor one day here and she said, ‘I'm going to stop prescribing opioids to all my patients effective immediately,” Nicolson says.
“We now have about a dozen studies that show that actually ripping somebody off their medication increases their risk of overdose and suicide by three to five times, destabilizes their health and mental health, often requires some hospitalization or emergency care, and can cause heart attacks,” says Kate Nicolson, founder of the National Pain Advocacy Center based in Boulder, Colorado. “It can kill people.” Nicolson was in pain for decades due to a surgical injury to the nerves leading to her spinal cord before surgeries fixed the problem.
Another issue is that primary care offices may view opioid use as a reason to turn down new patients. In a 2021 study, secret shoppers called primary care clinics in nine states, identifying themselves as long-term opioid users. When callers said their opioids were discontinued because their former physician retired, as opposed to an unspecified reason, they were more likely to be offered an appointment. Even so, more than 40 percent were refused an appointment. The study authors say their findings suggest that some physicians may try to avoid treating people who use opioids.
Abayomi-Paul says red flagging has changed how she fills prescriptions. “Once I go to one place, I try to [continue] going to that same place because of the amount of records that I have and making sure my medications don’t conflict,” Abayomi-Paul says.
Nicolson moved to Colorado from Washington D.C. in 2015, before the CDC issued its 2016 guidelines. When the guidelines came out, she found the change to be shockingly abrupt. “I went into the doctor one day here and she said, ‘I'm going to stop prescribing opioids to all my patients effective immediately.’” Since then, she’s spoken with dozens of patients who have been red-flagged or simply haven’t been able to access pain medication.
Despite her expertise, Nicolson isn’t positive she could successfully fill an opioid prescription today even if she needed one. At this point, she’s not sure exactly what various pharmacies would view as a red flag. And she’s not confident that these red flags even work. “You can have very legitimate reasons for being 50 miles away or having to go to multiple pharmacies, given that there are drug shortages now, as well as someone refusing to fill [a prescription.] It doesn't mean that you’re necessarily ‘drug seeking.’”
While there’s no easy solution. Whitelaw says clarifying the role of pharmacists and physicians in patient access to opioids could help people get the medication they need. He is seeking policy changes that focus on the needs of people in pain more than the number of prescriptions filled. He also advocates standardizing the definition of red flags and procedures for resolving them. Still, there will never be a single policy that can be applied to all people, explains Brushwood, the University of Florida professor. “You have to make a decision about each individual prescription.”
This article is part of the magazine, "The Future of Science In America: The Election Issue," co-published by LeapsMag, the Aspen Institute Science & Society Program, and GOOD.
When COVID-19 cases were surging in New York City in early spring, Chitra Mohan, a postdoctoral fellow at Weill Cornell, was overwhelmed with worry. But the pandemic was only part of her anxieties. Having come to the United States from India on a student visa that allowed her to work for a year after completing her degree, she had applied for a two-year extension, typically granted for those in STEM fields. But due to a clerical error—Mohan used an electronic signatureinstead of a handwritten one— her application was denied and she could no longerwork in the United States.
"I was put on unpaid leave and I lost my apartment and my health insurance—and that was in the middle of COVID!" she says.
Meanwhile her skills were very much needed in those unprecedented times. A molecular biologist studying how DNA can repair itself, Mohan was trained in reverse transcription polymerase chain reaction or RT-PCR—a lab technique that detects pathogens and is used to diagnose COVID-19. Mohan wanted to volunteer at testing centers, but because she couldn't legally work in the U.S., she wasn't allowed to help either. She moved to her cousin's house, hired a lawyer, and tried to restore her work status.
"I spent about $4,000 on lawyer fees and another $1,200 to pay for the motions I filed," she recalls. "I had to borrow money from my parents and my cousin because without my salary I just didn't have the $7,000 at hand." But the already narrow window of opportunity slammed completely shut when the Trump administration suspended issuing new visas for foreign researchers in June. All Mohan's attempts were denied. In August, she had to leave the country. "Given the recent work visa ban by the administration, all my options in the U.S. are closed," she wrote a bitter note on Twitter. "I have to uproot my entire life in NY for the past 6 years and leave." She eventually found a temporary position in Calcutta, where she can continue research.
Mohan is hardly alone in her visa saga. Many foreign scholars on H- and J-type visas and other permits that let them remain employed in America had been struggling to keep their rights to continue research, which in certain cases is crucial to battling the pandemic. Some had to leave the country, some filed every possible extension to buy time, and others are stuck in their home countries, unable to return. The already cumbersome process of applying for visas and extensions became crippled during the lockdowns. But in June, when President Trump extended and expanded immigration restrictions to cut the number of immigrant workers entering the U.S., the new limits left researchers' projects and careers in limbo—and some in jeopardy.
"We have been a beneficiary of this flow of human capacity and resource investment for many generations—and this is now threatened."
Rakesh Ramachandran, whose computational biology work contributed to one of the first coronavirus studies to map out its protein structures—is stranded in India. In early March, he had travelled there to attend a conference and visit the American consulate to stamp his H1 visa for a renewal, already granted. The pandemic shut down both the conference and the consulates, and Ramachandran hasn't been able to come back since. The consulates finally opened in September, but so far the online portal has no available appointment slots. "I'm told to keep trying," Ramachandran says.
The visa restrictions affected researchers worldwide, regardless of disciplines or countries. A Ph.D. student in neuroscience, Morgane Leroux had to do her experiments with mice at Gladstone Institutes in America and analyze the data back home at Sorbonne University in France. She had finished her first round of experiments when the lockdowns forced her to return to Paris, and she hasn't been able to come back to resume her work since. "I can't continue the experiments, which is really frustrating," she says, especially because she doesn't know what it means for her Ph.D. "I may have to entirely change my subject," she says, which she doesn't want to do—it would be a waste of time and money.
But besides wreaking havoc in scholars' personal lives and careers, the visa restrictions had—and will continue to have—tremendous deleterious effects on America's research and its global scientific competitiveness. "It's incredibly short-sighted and self-destructing to restrict the immigration of scientists into the U.S.," says Benjamin G. Neel, who directs the Laura and Isaac Perlmutter Cancer Center at New York University. "If they can't come here, they will go elsewhere," he says, causing a brain drain.
Neel in his lab with postdocs
(Courtesy of Neel)
Neel felt the outcomes of the shortsighted policies firsthand. In the past few months, his lab lost two postdoctoral researchers who had made major strides in understanding the biology of several particularly stubborn, treatment-resistant malignancies. One postdoc studied the underlying mechanisms responsible for 90 percent of pancreatic cancers and half of the colon ones. The other one devised a new system of modeling ovarian cancer in mice to test new therapeutic drug combinations for the deadliest tumor types—but had to return home to China.
"By working around the clock, she was able to get her paper accepted, but she hasn't been able to train us to use this new system, which can set us back six months," Neel says.
Her discoveries also helped the lab secure about $900,000 in grants for new research. Losing people like this is "literally killing the goose that lays the golden eggs," Neel adds. "If you want to make America poor again, this is the way to do it."
Cassidy R. Sugimoto at Indiana University Bloomington, who studies how scientific knowledge is produced and disseminated, says that scientists are the most productive when they are free to move, exchange ideas, and work at labs with the best equipment. Restricting that freedom reduces their achievement.
"Several empirical studied demonstrated the benefits to the U.S. by attracting and retaining foreign scientists. The disproportional number of our Nobel Prize winners were not only foreign-born but also foreign-educated," she says. Scientific advancement bolsters the country's economic prowess, too, so turning scholars away is bad for the economy long-term. "We have been a beneficiary of this flow of human capacity and resource investment for many generations—and this is now threatened," Sugimoto adds—because scientists will look elsewhere. "We are seeing them shifting to other countries that are more hospitable, both ideologically and in terms of health security. Many visiting scholars, postdocs, and graduate students who would otherwise come to the United States are now moving to Canada."
It's not only the Ph.D. students and postdocs who are affected. In some cases, even well-established professors who have already made their marks in the field and direct their own labs at prestigious research institutions may have to pack up and leave the country in the next few months. One scientist who directs a prominent neuroscience lab is betting on his visa renewal and a green card application, but if that's denied, the entire lab may be in jeopardy, as many grants hinge on his ability to stay employed in America.
"It's devastating to even think that it can happen," he says—after years of efforts invested. "I can't even comprehend how it would feel. It would be terrifying and really sad." (He asked to withhold his name for fear that it may adversely affect his applications.) Another scientist who originally shared her story for this article, later changed her mind and withdrew, worrying that speaking out may hurt the entire project, a high-profile COVID-19 effort. It's not how things should work in a democratic country, scientists admit, but that's the reality.
Still, some foreign scholars are speaking up. Mehmet Doğan, a physicist at University of California Berkeley who has been fighting a visa extension battle all year, says it's important to push back in an organized fashion with petitions and engage legislators. "This administration was very creative in finding subtle and not so subtle ways to make our lives more difficult," Doğan says. He adds that the newest rules, proposed by the Department of Homeland Security on September 24, could further limit the time scholars can stay, forcing them into continuous extension battles. That's why the upcoming election might be a turning point for foreign academics. "This election will decide if many of us will see the U.S. as the place to stay and work or whether we look at other countries," Doğan says, echoing the worries of Neel, Sugimoto, and others in academia.
Dogan on Zoom talking to his fellow union members of the Academic Researchers United, a union of almost 5,000 Academic Researchers.
(Credit: Ceyda Durmaz Dogan)
If this year has shown us anything, it is that viruses and pandemics know no borders as they sweep across the globe. Likewise, science can't be restrained by borders either. "Science is an international endeavor," says Neel—and right now humankind now needs unified scientific research more than ever, unhindered by immigration hurdles and visa wars. Humanity's wellbeing in America and beyond depends on it.
[Editor's Note: To read other articles in this special magazine issue, visit the beautifully designed e-reader version.]
Lina Zeldovich has written about science, medicine and technology for Popular Science, Smithsonian, National Geographic, Scientific American, Reader’s Digest, the New York Times and other major national and international publications. A Columbia J-School alumna, she has won several awards for her stories, including the ASJA Crisis Coverage Award for Covid reporting, and has been a contributing editor at Nautilus Magazine. In 2021, Zeldovich released her first book, The Other Dark Matter, published by the University of Chicago Press, about the science and business of turning waste into wealth and health. You can find her on http://linazeldovich.com/ and @linazeldovich.