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Brian Lehrer: It's The Brian Lehrer Show on WNYC. Good morning, everyone. Many of you know we've had a Health and Climate Tuesdays section of the show for the first 100 days of the Trump administration to make sure the big changes in those areas didn't get lost in the crush of headlines about other things that might seem more pressing on any given day. Today, on day 107, the first Tuesday outside that first 100-day window, we're announcing simply that we're going to keep it up. Health and climate Tuesdays will continue. Later, how they're canceling environmental justice programs and how that's affecting high pollution communities in New York, but first, new developments on RFK Jr. and vaccines.

New York Times Food and Drug Administration reporter Christina Jewett is with us. She's very much on the RFK Jr. beat. Her latest article is called Kennedy Issues Demands for Vaccine Approvals that Could Affect Fall Covid Boosters. Some of you have heard the basic headline on this, maybe just as much as I just said. Last Thursday, Kennedy announced that all new vaccines would need to be tested against placebos.

The question is, will each new annual tweak to the existing COVID vaccines, like they do with flu vaccines now, be treated like a brand new vaccine, which might make them impossible to produce? Let's see what's happening. We'll touch on a few other things, too. Christina, thanks for coming on. Welcome to WNYC.

Christina Jewett: Glad to be here, Brian.

Brian Lehrer: Start at the beginning, what was this announcement last Thursday in a little more detail than I just gave?

Christina Jewett: Sure. There was a bit of a kerfuffle with a vaccine by Novavax that caused some journalists to ask some more questions of the administration about what they were really looking for in terms of these updated COVID vaccines, which a lot like the flu vaccine, the viruses evolve and the formulas changed each year to attack the most recent strain of the virus. The administration came back and basically said there's not going to be a blank check of approval based on large studies from a few years ago. We're going to be requiring placebo-controlled clinical trials.

That really alarm some public health experts because as you hinted at before, if you are doing large studies in humans on the circulating strain, by the time you get the answer you're looking for and find out if there are any safety signals, the strain's changed and you're not going to have that formula on the market in time to protect the vulnerable people, the people with immunocompromised, people who are older, who really need that COVID vaccine to be safe.

Brian Lehrer: The question you write is how the department defines new. Why is that the key?

Christina Jewett: Well, the question is whether, each time you change the formula to reflect the latest strain, is that always going to be considered a new vaccine? I'm sure there are lawyers of all stripes scouring the regulations to figure out what the technical, legal answer is. Obviously, with the flu vaccine, when they change the strain, that's not really considered new, but with COVID, a different calculus sounds like is starting to come up.

Brian Lehrer: I think you just went to a point that a lot of people listening right now would have been wondering about. Is the annual tweak to the flu vaccine to update it for each year's recent strains considered new? You just said no, so why would an annual tweak to the COVID vaccine be any different?

Christina Jewett: That is the kind of conversation that you expect to commence a little more publicly. There is a meeting scheduled later this month of the FDA's vaccine advisors, and that's when we expect to learn a little bit more about the rationale, the plans, the question of how you can possibly or potentially get the answers that the administration wants in terms of what this new formula looks like and also protect the public because it's a balancing act.

It's not a Twitter argument of, hey, we should do this and be sure it's 100% safe and there's no unknown adverse events. This is real life. Children with leukemia could die if you hold things up to have perfection instead of having more of a balanced approach. We really don't know where things are right now. The administration hasn't talked extensively beyond statements in terms of its thinking on this.

Brian Lehrer: Were they being purposely opaque? I would think if they announce going forward, all new vaccines are going to have to be tested against placebos. Placebo studies, for people who don't know, basically, are studies where some people get the thing with the active ingredient, some people get what looks like the same thing, like a shot, whatever it is, without the active ingredient, and then they could tell over time whether the thing was safe or the thing was not safe or effective or not effective. That's a placebo study.

If they're going to say all new vaccines have to be tested against placebos, the obvious question is, how's this going to affect COVID vaccines for this fall, for like four months from now? Why wouldn't they say?

Christina Jewett: At this point, I can only speculate. The speculation would be that perhaps there's internal tension, maybe there's internal debate about how you're going to satisfy these two imperatives. It's clearly an imperative for Mr. Kennedy to raise the bar on what we know about vaccines, looking for those side effects that can be rare. That's obviously very important to him if you've listened to him over the last decade or so. Flip side being there will be certain death if you hold that bar so high before you release a product to the public. People who are, like I said, organ transplants, cancer patients, the older folks in congregate care living, those are extremely high-risk individuals who really benefit from that COVID shot.

Brian Lehrer: Listeners, your questions, comments, and stories welcome for New York Times Food and Drug Administration reporter Christina Jewett, closely covering RFK Jr. as Secretary of Health and Human Services, as well as other people and things. 212-433-WNYC, 212-433-9692. We'll get to some other stories as well, including one that's a separate story but really related. Kennedy has announced that he's going to find the cause of autism by September. How's he going to do that? If scientists have been looking for the cause of autism for decades, how's he going to do it by four months from now?

Another one, Kennedy accuses FDA of drug industry influence that barred alternative remedies. That certainly sounds plausible. We're going to touch on that and maybe some other things as we go with Christina Jewett from The New York Times. 212-433-WNYC, 212-433-9692. Call or text. You did quote a Health and Human Services spokesman on the vaccines, saying this will, in fact, be a radical departure from existing standards. Radical in what ways, according to them, if they said?

Christina Jewett: That was puzzling to the experts we talked to as well. I think it's a radical departure if you've spent years of vaccine criticism focused on studies that were done 20, 30, 40 years ago. As a reporter covering the FDA, I think that's true across the board. You look at any drug that was approved 30 years ago, a lot of times, the standards are very different from what you see now. If that's been your orientation for a long time, you might believe that requiring placebo controls for vaccine trials is a radical departure, but I think the reality is more that that's become the norm, the standard in the last 10 years. I think things have progressed and updated.

The other wrinkle there is that Mr. Kennedy, over the years, has had a niche complaint on vaccine studies. He wants the placebo to be saline. He doesn't like it when the placebo is basically the vaccine minus the immune system-activating component, because he's concerned that some of the ingredients in the vaccine could be causing mischief. The placebos of Yore are viewed as very suspicious to him. Many in the field find that to be puzzling. They don't see any likelihood that any of those ingredients are really causing any problems. I think that might be what their thinking is, but again, we're not getting a whole lot of information out of the administration.

Brian Lehrer: What you said about placebo studies and his take on it is really interesting. Let me ask a follow-up question on that. In fact, I'll acknowledge after my quick description of what a placebo study is, a listener wrote, "Brian, you are not accurate with the statement. Without the active ingredient, the placebo must be inert, as in saline, not what has been done in the past."

I guess that makes sense, Christina, in a certain way. If the active ingredient is whatever the drug is or whatever the preventative vaccine substance is, maybe the thing that might cause a side effect is a preservative, not the active ingredient itself or some other additive that's there for one reason or another. That's what Kennedy is getting at with that, right?

Christina Jewett: I think that's his thinking, though I do-- The orientation of your more mainstream experts on vaccines takes you back to an old cemetery. You might drive by on your way into rural Pennsylvania, where you see so many tiny gravestones, and you walk through, and you see so many children who died at age four, six, seven. You think about the very incredible benefit of vaccines, of millions of lives saved, the reality that any medical product that's bioactive will have some side effects, and the sensibility that that's been studied incredibly carefully and that those products are pretty well characterized.

There will be people who are hurt and that's the reality, but the broader risk-benefit picture is that vaccines protect us from really dreadful diseases. That's where you get hunting into what some might consider a hair-splitting level of detail to find a 1 in 10,000 problem, versus protecting a population from diseases we don't even want to think about that could leave our children deaf or dead.

Brian Lehrer: That's right. I'll say even for myself, I recently got a measles, mumps, and rubella titer, which, as you know, means testing to see if I'm still immune. If RFK Jr. and other people are unleashing a measles epidemic or just a rise in measles cases around the country when it was basically wiped out in the United States for so long, and it's so contagious, I wanted to know if I was still immune. A lot of people around my age are getting the same test.

Luckily, I am immune from measles, mumps, and rubella, but this is the new world we're living in where people have to even ask themselves the question, "Am I still immune after all these years?" and think about getting that test for themselves, depending on their certain circumstances. You remind us in your article of some of Kennedy's past campaigns against COVID vaccines, petitioning the Food and Drug Administration to pull the COVID vaccine off the market in 2021 during a deadly phase of the pandemic.

He also urged the FDA not to authorize COVID shots for children. They really were, though new vaccines at that time. In fairness, President Trump in 2020 called their development operation Warp Speed. Were they tested against placebos then?

Christina Jewett: Oh, yes, absolutely. They were tested against placebos in large trials, about 30,000 people for the Pfizer and Moderna shots.

Brian Lehrer: You remind us Kennedy has been vocal about his disdain for mRNA vaccines like the COVID ones. Remind us, what's an mRNA vaccine?

Christina Jewett: It's a somewhat new platform, but it's been studied for more than a decade, that offers a really high degree against COVID, that has had some side effects, myocarditis, swelling in the heart tissues among young men. That's been of high concern to Mr. Kennedy to make sure that's explored incredibly thoroughly. It's also protected millions of people worldwide from a virus that came out like gangbusters and killed millions of people worldwide.

Brian Lehrer: Including a million, they say, in the United States. We have so much real-world experience now with COVID vaccines that any health risks should be apparent through actual cases. Is there a good vaccine side effects database or system of tracking them that the government keeps?

Christina Jewett: Yes. There are several systems. There's one called the Vaccine Safety Data Link that's housed at the CDC that was used during COVID to carefully look at-- There are multiple databases. One is called FAERS, that's the Adverse Event Reporting System. There are statistical ways you can look at all the different-- Just anyone can report a problem there and people can spot, okay, are we seeing more of this than you'd expect in the population, and then you can take that a step farther in these databases that query millions of electronic health records and say, okay, you're giving this vaccine to hundreds of millions of people.

Of course, people are going to come down with all kinds of illnesses over that time. Is this a coincidence, or is there causation? That was used to find some problems with the Johnson & Johnson vaccine, with blood clotting, a rare disorder. That vaccine was discontinued in the US, and that's also how they found myocarditis in the young men. There are systems. There has been really careful watching. I'm certainly not someone who would say that there's nothing we don't know if we don't look deeper. I don't call anyone who's asking questions crazy. I think those things are always worth investigating. I think the big social, societal balance and the costs and the risk benefit ratio has to always be in the forefront.

Brian Lehrer: Funny enough, you write in your article that Kennedy has said he intends to restore trust in the vaccine approval process, but then you quote Dr. Jesse Goodman, a former FDA official and infectious diseases doctor at Georgetown, who said the changes could erode trust. He said, "Questions never bother me, but it's really worrisome when it seems like they're so ubiquitous and so constant that they sow a huge amount of doubt, not just about the one thing, but about everything." What does Kennedy mean by he intends to restore trust in the vaccine approval process? It seems like he's trying to sow distrust.

Christina Jewett: I think from his perspective that, like I said, really running these questions down to the ground. I think some of the studies that might be required would be huge and lengthy, and difficult to get done. I think he views that as a way to restore trust. I think others, obviously, like Mr. Goodman, see that through a different light.

Brian Lehrer: Sonny in lower Manhattan has a question about the ethics of placebo studies at all in certain circumstances. Sonny, you're on WNYC with Christina Jewett, FDA reporter for The New York Times. Hi.

Sonny: Hi. I should have also mentioned that I do have a medical background. I don't practice anymore, but I'm a physician. I just want to make it very clear that he's also making it impossible in some circumstances, because you can't do a placebo trial if there's already a standard of treatment that's considered like, "That's what we do." Let's say, for example, we know that everybody benefits from taking an aspirin after a heart attack. We don't do placebo trials and withhold something that we know is effective.

If we get a new measles vaccine, we don't take 1,000 kids and say, "You get no vaccine." A trial would be against what standard of care? This is somebody who doesn't understand basic science and how medicine works, making a decision like this. Remember the controversy with HIV meds. They went to Africa to do studies because there are no people in America who could be on a placebo trial, because people in America could get medications. That was considered a horrible ethical thing, that they went to Africa, withheld medications that they knew would help because they were like, "We have to do a placebo trial."

That was part of what Tuskegee was. It was about understanding the natural history by withholding medications. There's a whole different aspect that nobody's touched on in terms of it sounds great, but you can't do placebo trials all the time. It's just impossible because it's actually medically and ethically wrong to withhold treatment that you know is standard of care and effective.

Brian Lehrer: Sonny, thank you for that very clear discussion of the ethics of placebo studies. Where do they tend to draw the line? Sonny cited some cases that were really outrageously over the line, I think, by general consensus at this point. Where do they draw the line, and when it's ethical to withhold something that might help somebody with a serious illness or potential serious illness to test it against a placebo?

Christina Jewett: What's available is millions of electronic health records that can help answer these questions without creating those ethical dilemmas or ethical bright lines where you can't expose people to certain death or a small group, much less an entire population. Some of the administration's questions seem to be about efficacy. Does everyone need a COVID booster every year? Obviously, people have opted against that. About 23% of adults got the booster last year. Those questions and the subgroups, all of that can be ascertained from data that doesn't expose anyone to great risk.

From just looking at the people who got the shot last year compared to those who didn't, you can do those subgroup analyses. There's a group that did that work that the CDC published. You could get those folks around a table and say, "Can we drill deeper into the data and tell people?" If you're 35 years old and you've had COVID and you've had the original series of the vaccine, what is your risk? The administration seems very interested in answering those questions, and it's probably ascertainable with information that's already on the table.

That's a really, really good point by the caller. I think that's why this was a big headline. People were like-- just head explosion emoji all over the place. Like, you can't really do this. You can't do this with a small group, and if you try to do this with an entire population, you'll kill thousands of people. This isn't a Twitter debate, this is reality. The question really is what's next, and where does the administration go from here?

Brian Lehrer: A listener writes, "There's a common side effect of pediatric vaccines, adulthood." Nicely put, Steve, in Hell's Kitchen. Listener, though, asks a more skeptical question, says, "Regarding vaccine adverse reporting, it relies on voluntary reporting. Doctors are not reimbursed and are not reporting as much as they need." "I had an adverse reaction to the COVID vaccine," writes a listener, "and neither my primary, the cardiologist treating the event or the hospital reported it. I'm a pro-vaccine nurse, but the system is flawed." That's interesting. I guess with any kind of side effect, if it's not serious enough to report it to the government or even report it to your doctor, there might be an undercounting.

Christina Jewett: That's true across the medical spectrum, from medical devices to medications to foodborne illnesses. That is definitely a problem. The other thing you'll see if you carefully watch FDA deliberations, they do talk about something that they call stimulated reporting, which is-- I saw this with an asthma medication, Singulair, which a lot of people have reported psychiatric problems related to that. When the FDA was discussing the risk-benefit of that drug, they talked about how there had been a wave of news coverage years ago, and that stimulated reporting that many people voluntarily sent in reports after that coverage.

I think that's one of those things that's really hard to tease out with the COVID vaccine, is when that's in the air, that this new technology could potentially cause harm, then do you have the stimulated reporting versus underreporting, which is a pretty chronic problem. Those things are really hard to sort out, and there is ways to get past that these days with big data, which is imperfect, but it is a good tool.

Brian Lehrer: We'll continue in a minute with Christina Jewett, who covers the FDA, and these days, a lot of RFK Jr. coverage for The New York Times. We'll touch on how he anticipates discovering the true cause of autism between now and September, when scientists have been studying it for decades. We'll get to Christina's article, Kennedy Accuses FDA of Drug Industry Influence that Barred Alternative Remedies. A lot of you who might otherwise hate RFK Jr. may be nodding your head at that one and maybe one or two other things that she's been reporting about food and drug safety. Stay with us. More of your calls, too.

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Brian Lehrer: Brian Lehrer on WNYC with Christina Jewett, who covers the FDA, including Robert F. Kennedy Jr.'s Health and Human Services secretariat for The New York Times. Christina, a related Kennedy story to the one we've been discussing is that he announced a plan to discover the causes of autism by September. Your article on that says experts are skeptical of that timetable. What's the background on that? Haven't scientists been studying the causes of autism for decades?

Christina Jewett: He has walked that back a bit. I think he's pivoted to say we'll have some preliminary ideas by September, but we might not have an answer for a year out. This is an area of a lot of study, which, of course, could also be better funded, could certainly have more focus. Having had some time to think about this since that story came out, they are planning to do some studies. They also want to employ big data and get some researchers with proposals. They're going to review the proposals and approve what looks promising.

A lot of the talk about this from the administration has been looking at dietary and environmental exposures from birth to age around two, when autism becomes apparent. What struck me is that there are very prominent scientists who are focused on the very early days after conception as the potential moment when there's an insult that could lead to autism. Whatever study they're looking at, it's not clear if they would pick that up, if you could even pick that up with careful study, and under three or four years, if you are able to follow people who are trying to conceive.

You can imagine that would be a difficult study to put together. I guess there was even an effort about 15 years ago that was very costly and big and just fizzled. That's where things are right now. You can study anything and look for associations, and you'll find some. It's really going to be a question of whether a second phase of study shows that there's really any there. These types of investigations can take a really long time to do in a way that's really convincing to the medical establishment.

Brian Lehrer: Bernadette in Mount Laurel has a question about that, I think. Bernadette, you're on WNYC. Hello.

Bernadette: Hello, and thank you for taking my call. I hope you can hear me.

Brian Lehrer: We can hear you.

Bernadette: My comment was, and I guess it's also a question, with the Trump administration being so cost-sensitive, why would they want to redo a lot of studies that have already been done in a lot of detail? I don't understand that. Another comment that I have is I'm really not a conspiracy theorist, but when I think about what RFK is talking about and promoting, it just seems to me that the people who will suffer the most are the most vulnerable people in the population. It just makes me somewhat suspicious.

Brian Lehrer: We have another listener who's suspicious in the way you are. I'm not sure if I can find this text because we've gotten so many in the last half hour or so, but a person says, "Maybe this is one of the ways they're aiming at eugenics." That was the gist of that text. That's basically what you're saying, the anti-DEI push, eliminate unwanted, vulnerable people from the population, Bernadette?

Bernadette: I guess so. To my ears, and I'm not being critical. That really sounds harsh, but I guess the way I see it is more, and maybe I'm being too kind, a lack of sympathy for the more vulnerable. The people who are immunocompromised, the people who are older, or people who have diseases that make them more vulnerable. It just seems to me that there's something of a deaf ear to that. The other thing, as our conversation is going on, that I wonder about is if the program of Trump is to make America great again, we have fallen behind in maternal and child health from a lot of other countries. It seems to me that we should be putting more efforts into getting our care of newborns and pregnant and new mothers, looking at what's happening in this country to make our numbers so much worse than so many other countries.

Brian Lehrer: Bernadette, thank you for your call and for raising all those points. To her last point, Christina, and tying into her first point, which is, if they want to save a lot of money, why are they spending so much money on this? I guess we could look at the big picture of what they're spending on and what they're cutting in terms of health services and say, why are they going to spend a lot of money trying to reinvestigate something that seems generally proven, meaning like COVID vaccines are safe, MMR vaccines are safe, while at the same time, just to cite another one of your headlines from last month, mass layoffs hit health agencies that track disease and regulate food.

I don't know if you've had the opportunity to ask them to justify why they're concentrating money and where they're withdrawing money, laying off 10,000 or more employees from HHS, how that makes sense.

Christina Jewett: The statistic you could dig down for one more good headline, and you'll see that I talked to a number of budget experts. A lot of federal researchers who are looking for cures for diseases, regulators who are keeping our food and drugs safe, looking for carcinogens and drugs, and looking for listeria and food, clear killers. The cuts are mind-boggling when you consider what some budget experts told me, which is basically that the federal workforce is 1% of about the 1.7 trillion that's spent on health care in this country.

It's actually less than 1% because all that spending is this massive ATM called Medicare payments that go out to hospitals, nursing homes, dialysis centers. They pay for medications, medical devices. Do all of these things help relieve suffering? Probably not. You could probably save a whole lot of money by finding 10 high-expense, low-output products and get rid of them tomorrow. You could probably leave the federal workforce intact. There is these questions of let's look at the big picture and really improve the nation's health, whether poking at some yet unknown vaccine side effect is the way to get there, or whether really thinking about proportionality is the way to get there.

There are some pretty well-known suspects that are pretty boring and unsexy to talk about, cigarettes. There are still millions of people who smoke them. Tackle that and you really can make an impact on chronic disease. Sodium. When you pick up that broth at the grocery store and you look at what percent of your daily sodium, the bowl of soup you're going to serve your family is going to be. Not a good situation. There are some really unsexy areas where the data might really show something that's worth tackling.

Brian Lehrer: Where the public impact could be much greater. By the way, on the studying the causes of autism, you also reported that Kennedy hired a discredited vaccine skeptic to lead that study. Who's that person, and why did you say discredited?

Christina Jewett: He has worked for years with his father. He doesn't have a medical degree or medical training, and he was disciplined by the medical board in Maryland for acting like a doctor without a license. For a time, his father was offering unproven treatments to children with autism, things like puberty blockers on an experimental basis, he believed would help the kids. The documentation basically showed the son sitting there behind the desk in the office, speaking to patients in a way that would lead them to believe he was a doctor when he wasn't.

This is someone who's worked with Kennedy over the years, has produced some studies that experts in biostatistics found to be really specious, connecting vaccines to autism. This is who Mr. Kennedy brought in to study the question. A lot of people think that the answer is baked into the cake already, but no one with medical training is going to buy it. Then the question is, what could the harm be to the broader confidence in vaccines if this marches forward? That's some of the concerns around Mr. David Guyer.

Brian Lehrer: Here's an interesting question from a listener in a text that says, "If RFK Jr. doesn't allow the COVID vaccine booster to be updated for the fall, will it be worth it financially for Pfizer and Moderna to update it for other countries?" In other words, asks the listener, could an American wanting the updated booster go to Canada?

Christina Jewett: No, I've heard people talking about that. I somehow doubt that we'll get there, but that is something that's being talked about. I think it will be worth their while to make those.

Brian Lehrer: You doubt that in the end that the COVID booster for this year will not be available in the fall? You doubt that it's going to wind up with that extreme an outcome?

Christina Jewett: There's been a lot of-- I don't think that's likely. When you think about the scale of almost certain death, as the caller mentioned, to people who are immunocompromised, that just doesn't seem like a path that we'll see the administration go down, but time will tell.

Brian Lehrer: On the other hand, we have this very pointed comment from a listener who says, "Feels like a death cult. MAGA don't even care about their own health." That's the opinion of one listener. Before you go, I said we were going to get to this other article of yours, Kennedy accuses FDA of drug industry influence that barred alternative remedies. That certainly sounds plausible. How specific does he get on that?

Christina Jewett: He doesn't get very specific on that. It's something he had tweeted about in the past. He accused the FDA of being in the pocket of big pharma and obstructing things like ivermectin and stem cells that, if they were truly effective, would certainly have a pathway to approval. Yes, it would be costly to meet the FDA's standards, but that's been a long-standing concern of his that somehow the FDA is locking out treatments that are otherwise effective.

Brian Lehrer: There are so many other things we could talk about. We'll have to have you back on another Tuesday or another day. Christina Jewett covers the FDA, including a lot of RFK Jr. stories these days for The New York Times. Thank you so much for joining us. Really informative.

Christina Jewett: Thank you, Brian. I appreciate it.

Brian Lehrer: Brian Lehrer on WNYC. More in a minute.

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