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Dr. Nicole Safire
Welcome to Wellness Unmass. I'm Dr. Nicole Safire and we are going to dive right in. It has been a really busy week last couple of weeks. Between the two days worth of ACIP meetings with the CDC and also the big press conference with President Trump and essentially the entire HHS standing behind him. We have a lot to cover and I mean we only have 30 minutes, so it's a lot to cover, but we're gonna do it. I am always very honest with everyone, my opinions. People sometimes get mad at me because they feel like I'm not a loyalist, whether one way or the other. But at the end of the day, I think my role as a physician, as a human, as an American is to kind of just tell you what I'm thinking and kind of make some sense of all this mess. We did that throughout Covid and we're gonna keep doing that right now. So the good news is during the White House press conference they kind of talked about what those ACIP meetings were all about. So we can combine them all. One of the big things that came out of the ACIP meeting was that the formal recommendation is to separate the MMR vaccine that measles, mumps and rubella from the varicella vaccine. Varicella is chickenpox. It was a formal recommendation saying for kids under four, so that first dose of the vaccine, they should be separated into two separate injections. Well, this isn't really groundbreaking news. In fact, that was already the recommendation from ACIP from about a decade ago. They're just now saying insurance companies are not going to cover it. If you want to choose to have that combined dose, the reason they recommend having those two doses separated is because when they found that they combined the four different vaccines, the measles, the mumps, rubella and varicella, there was a slightly higher risk of febrile and afebrile post vaccination seizures. And that's real. Thankfully, the majority of children recover without incident from these seizures. But they're still scary and if we can avoid seizures, I think that would be the right thing to do. So it makes sense. They Found children over the age of four didn't have this risk of seizures following it. So after the age of four, you can combine the vaccines. So for about 85% of all children for the last eight to 10 years or so, they've already had these vaccines separated, meaning they have to come back for two different doctor's appointments to get two different vaccines. 15% of kids were still getting that combined dose, even knowing there was a slightly higher risk of seizures. So the pediatricians who were administrating the combined dose for kids under 4, they did this knowing there was a slightly increased risk of seizures, but they were concerned whether they were concerned the parents wouldn't come back for the second dose or whatever. The reasons being, they had to weigh that risk with potential benefit of the vaccine. This latest ACIP is saying that is no longer an option. You have to separate the doses. I don't see anything wrong with this. In fact, I agree with it. If we can avoid a risk of seizures, we should be doing it. So this is great news. I think that's fine. The other big issue that came out of the ACIP meetings was what to do with the birth dose of the hepatitis B vaccine. Should all children be given this vaccine before they leave the hospital? The birth dose, you know, this is something that I've talked about a lot. I don't necessarily think it's necessary. I think this is one of those vaccines that should be done based on risk. Since the 1980s, 1990s, when the hepatitis B vaccine became available, yes, we saw cases of hepatitis B go down. Another thing that was also happening during this time was we started testing pregnant women for hepatitis B virus to know what their status was, that could also have contributed to the decrease in babies being born with hepatitis B. For me, my opinion is if a woman recently tested negative for hepatitis B and they're living a low risk lifestyle, no IV drug use, not a sex worker, they don't have a hepatitis B positive person living in the home and the newborn probably doesn't need this vaccine and we can have a conversation about whether or not they should get the vaccine later in life. What the ACIP was wanting to vote on was saying, we're not going to give that dose at birth, we just want to give it at one month when the baby's slightly older. The problem with that is there's no data that supports or goes against the birth dose versus one month. So how can you really have that conversation or even put forth a recommendation? The reality is you can't, which is why they decided not to. There was a motion to postpone the conversation indefinitely. So they didn't even vote on that. President Trump brought that back up at the press conference. I'm gonna get to that. I just wanna mention the third thing that came out of the ACIP meetings before we move on to the press conference. The third thing that came out was all about the COVID vaccine. And this is what we were all kind of waiting for. What are going to be the formal recommendations? And the big thing was ACIP finally is saying no more universal recommendation for Covid vaccines and boosters. What was the mantra of the entire Biden administration of every baby 6 months and older to adulthood until the day you die. You should be getting the full vaccine series of COVID plus one, maybe even two boosters every single year into perpetuity. Obviously that makes no sense as we have gone on to show that the virus itself has starting to decrease in severity and virulence. You have so much natural immunity, we have a lot of vaccine induced immunity. And really this should also be one of those risk vaccines. The higher risk you are, the more you should consider the boosters. And especially in the low risk populations, like specifically adolescents and school age kids, the risk benefit scenario with the COVID vaccine just may not make sense. And that's essentially what ACIP said. Now, they did not go as far to say that you can't access the vaccine if you are a healthy young adult or a healthy adolescent. They didn't say that at all. In fact, they tried to vote saying you needed a prescription and they tried to decrease access to the vaccines, but those votes failed. The only votes that passed in ACIP regarding the COVID vaccine is just to change the recommendations that it should be risk based. And anyone else considering the vaccine should have a conversation with their doctor about the risks and benefits of this vaccine. And I think how could anybody argue with that? Of course, you should always have that conversation and physicians should be forthcoming with the, you know, perhaps very low benefit of vaccines in a healthy individual and the very real risks, especially in adolescent boys with this vaccine. I think these conversations, this information, these are all good things. I think it's great that the votes didn't pass restricting access. If the vote for requiring a prescription for this vaccine would have passed, it would have been a logistical nightmare. But it didn't. So there's really nothing bad you can say about. I think everything that happened was good. It was very frustrating to watch some of the ACIP meetings. Clearly a lot of the people who are Putting together the votes and some of the talking points have no idea what it's like practicing medicine. They have only worked in a lab or have only been surrounded by data, which you need those people. You need people who are very good at data. But you also have to balance that with the practicality of what it's like working in real world healthcare. Didn't feel like we had much of that balance. Definitely felt like a lot of ideology was being presented, a lot of flawed data that in the real world of academia we would never even consider because a lot of it was not legitimate. Some of it was, but a lot of it was not. It was very frustrating. But I don't. We don't need to get into the details of that. You know why? Because the granular details don't even matter. Because the results were fine. And I think all of those results are fine. And anybody who's causing an uproar over it don't really understand the implications. Nothing major has changed. It's all going to be okay. Now let's fast forward to the big White House press briefing or announcement that just came Monday night. This was a big deal, and let me tell you, it was really painful to watch. President Trump came out. He was flagged behind him by HHS Secretary RFK Jr. FDA Commissioner Marty Makary, NIH Director Jay Bhattacharya, and CMS Director Mehmet Oz. There was a lot of information presented at this press conference. Some of it was factually correct, some of it was factually incorrect. The problem I had was it was full of hyperbole. And not only do facts matter, but the messaging matters too. And I can only say this so many times. The overarching message of this press conference is that autism rates are on the rise. They are. Yes. Some of that has to do with the expanded diagnostic criteria of autism Spectrum disorder and including Asperger's and others. So, yes, that contributes to it. You can't deny that that absolutely contributes to it. But something more is going on. There are more children being born with neurodegenerative diseases than before. That's also undeniable. So the question is, why is that? The conversation about acetaminophen, commonly known as paracetamol or Tylenol, but acetaminophen in pregnancy and associated with ADHD in the baby, or autism Spectrum disorder. This is not a new conversation, and in fact, we've been having it for decades. Why is that? Because there have been a lot of observational studies that have looked at women who have taken acetaminophen and the potential risk of autism. There have been a good amount of observational studies looking at women who have taken acetaminophen during pregnancy and a slight increased risk of autism spectrum diagnosis and ADHD in their babies. Now, these are what we call observational studies, meaning one of the bigger ones was, I think 2019 from Johns Hopkins. They looked at cord blood analysis, you know, the blood in an umbilical cord, and they found higher metabolites from acetaminophen in the children who were born with autism. So does that correlation mean that the acetaminophen caused the autism? Well, again, correlation does not mean causation. And I think you're probably going to hear that a lot of times. We heard a lot of that during COVID and you're going to hear it now. But it's true. Correlation means that, okay, there was acetaminophen there and now the child has autism. So it's a correlate. But was it the acetaminophen that caused the autism? And that's what the studies haven't proven yet because why are people taking acetaminophen? Well, yes, we take it for a pain reliever. We also take it for fever. So if a woman, a pregnant woman, gets an infection and then she gets all that inflammation and that inflammation causes the fever, it's the body's natural response to try and fight off that infection. And oftentimes they'll take Tylenol to reduce that fever. So what is it exactly that's causing autism? Is it the infection? Is it the inflammation? Or was it the Tylenol? All of these things are potential correlates. They have not actually figured out what is the cause. You're listening to wellness en masse. We'll be right back with more.
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Dr. Nicole Safire
At this press conference, no new data was presented. Yes, they highlighted a recently published study just last month that included some Harvard profess professors in it public health. And what that was was a meta analysis. It wasn't new data. They just said, look at all of these studies. All of these studies have shown that there may be a correlate between acetaminophen use and autism that's undeniable. You cannot deny that that exists. But you also can't deny the flip side of that, which is there have been studies, specifically a very large one out of Sweden, that included about 2.5 million kids where they TR control for that correlation. They looked at siblings and they looked and they tried to remove some of those confounding factors. And what they found was before they removed those confounding factors, there was about a 5% increased risk of a child being born with autism spectrum disorder or ADHD if Tylenol was used. But when they removed some of those other factors, that risk went down to zero. So they found there was no causal link of acetaminophen and autism spectrum disorder. So no one has been able to prove causative link between acetaminophen and autism spectrum disorder. FDA Commissioner Marty Makary quoted this Harvard study and he said that they were able to find a causal link. But I have to be honest with you, if you read the study, no, they didn't. And they say they didn't. They said, and I want to actually just quote it here because I don't want to give you my opinion. I want to quote exactly what the study says. Our analysis demonstrated evidence consistent with an association between exposure to acetaminophen during pregnancy and offspring with neurodegenerative disorders, including ASD and adhd. Though observational limitations preclude definitive causation. So again, there are studies showing there's a correlation, but there is not a strong study showing causation. And even though what was said at the press conference yesterday was that they have found a study pointing to causation, that's just not true. Now the takeaway isn't, well, we should just take as much acetaminophen as we want in pregnancy. No, absolutely not. There are still enough studies there, there's enough correlation that we have to err on the side of caution. And. And that is really what the message should be. It should be that for minor aches and pains, you have to try other things. You want to try massage, acupuncture, aromatherapy, anything. Just trying to relax. Don't grab for the Tylenol bottle anytime you want. But we have to really do away from that paternalistic culture where the President came out and said, you just have to toughen it out. That's really hard, I'll be honest, for a woman to hear. Not because, oh, we can't toughen it out. I'll be honest. I think women are much more tough than men, specifically when it comes to physical ailments. But it's not about toughing it out, certainly not when pregnancy. When we're talking about pregnancy, there are a lot of physiological changes that occur. And while I think for the majority of aches and pains, we can toughen it out, and we should, especially because there's a potential correlative link of neurodegenerative disorder and acetaminophen. However, I can also tell you, when it comes to high fever, there should be no amount of toughing it out, because when women have fever in pregnancy, they have up to a 40% risk of a child with neurodegenerative disorder. If they have multiple fevers during pregnancy, especially in that second and third trimester, that risk triples. That is significantly higher than any risk that has ever been reported using acetaminophen when it comes to neurodegenerative disorder. So my biggest fear is that the message at this press conference was women should not consider acetaminophen in pregnancy, no matter what. They have more fear now from that medication, and they don't have the fear of a high fever, which is a much bigger risk for not only the mother, but that baby that's forming, too. So the messaging was wrong, in my opinion. The President continued to come out and saying, Tylenol is bad, Tylenol is bad. The message should have been, Tylenol should be used sparingly in pregnant women. There's research there, but it's unfinished research. We need to put more time and effort into this because we have to make sure that pregnant women have something safe to take during pregnancy. And the constellation of research right now tells us that using Tylenol sparingly at the lowest possible effective dose is what's safest for the mother and baby, especially in cases of high fever. That message was lost at the press conference yesterday, and I think that was very unfortunate, because when we're in a time of chaos and public trust, public trust erosion. Messaging matters. It really does. Now there's a firestorm across the country that is just creating this massive divide and the reality is it shouldn't have been. This was a great message that came out of the White House. What it was was reinforcing an already existing warning when it came to acetaminophen use and pregnancy that there are some concerns there, but still it remains the safest medication when it comes to treating high fevers. Full stop. That should have been the message. It tumbled a bit throughout and like I said, there were some factual inaccuracies that were presented. Moving on from Tylenol, more was said and it kind of just devolved from there. The President also mentioned hepatitis B. He said that maybe hepatitis B should be given at the age of 12. That vaccine that we had kind of heard about during acip, that was a first. I haven't heard anybody else mentioning 12. I haven't seen any data showing that 12 is the right age. My guess is maybe that is because hepatitis B can be sexually transmitted and that is the time pre pubescence where maybe sexual activity is starting. So maybe that's the mindset behind that recommendation. We haven't heard from the CDC or the ACIP about it or the FDA or really anybody. So it was kind of off the cuff by the President. I'm sure we'll be hearing more about that in the future. Maybe age 12 makes more sense than a birth dose for me that it sounds a little bit more reasonable because if it's sexually transmitted then maybe that's it. More coming up on Wellness unmasked with Dr. Nicole Safire.
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Dr. Nicole Safire
And he mentioned the MMR vaccine and the varicella separating them. That also makes sense. I already said that. But then he kind of got into, he brought the Tylenol back saying and don't give Tylenol to your babies after your vaccines. And this was very confusing because that had nothing to do with what the FDA was talking about. The FDA was specifically talking about Tylenol in pregnant women and its role in brain development. So it would be nice if the FDA kind of clarified a little bit more what they are meaning is the President saying that the formal recommendation is not to give Tylenol at all in infants and toddlers and school age children. I think that left a lot of people very confused. And so it would be great to have some clarification there on what they were talking about. And if there was actually some data to support what was being said, they didn't point to any. Another big thing that did came out, which I was very excited about, was the conversation around treating children born with autism spectrum disorder with something called leucovorin or which is essentially a reduced version of folate. Folate. If you think of folic acid, that's the big thing in all the prenatal vitamins. We already know that folate and folic acid is extremely important for the development of the fetus in a pregnant patient, which is why prenatal vitamins are so strongly recommended. Children born with autism spectrum disorder oftentimes are found to have low folate levels. They're also found to have autoimmune antibodies against folate receptors in the brain. And several studies have shown when you increase folate in the mother, you actually decrease the risk of autism. So the fact that the conversation around that is now being amplified, that's an incredible thing. Leucovorin is a prescription medication that can potentially treat these children who are born with the autoantibodies to the leucovorin receptor or just low folic acid levels. Studies have shown that it does help improve some of the verbal communication. Obviously these are small studies and more studies will need to be done. But at this point I think any parent who has a child born with, with autism spectrum disorder, they just want anything. They want anything that might be able to help. So I think it's wonderful to amplify this. And then Dr. Oz came out and said CMS will cover it as well because obviously it's great to have a medication but if you can't afford it and you can't access it, that's a big problem. Marty Makary said that they've already talked to the drug manufacturer and they're going to increase production. And then Mehem Oz said CMS is going to cover it. Half of our children are on Medicaid or CHIP programs, so they get their medications and healthcare through government assisted programs. So at least half the children are going to have access to it and have it be covered. I'm sure private insurers will follow suit as they tend to do so. I'm sure with lobbying efforts that'll happen. So these are great things. Again, if we could just take the press conference and say, pregnant woman, you need to use Tylenol sparingly during pregnancy and only under the advice of your obstetrician. If you have a high fever, these are the times to consider taking Tylenol. If you have minor aches and pains, try everything else first. This should have been the messaging when it comes to the vaccines. I think they should have left this one out. I don't understand why there is much conversation about vaccines in this press conference. It really didn't have much to do with anything that they were talking about. There is a succinct way to talk about what the conclusions were at the ACIP meeting last week. This press conference did not do it. It created more fear, more doubt, and really riled up the whole back and forth when it comes to people who are pro vaccines and those who are against vaccines. The reality is there's a happy medium there and we need to make sure that we're harnessing that happy medium because the country is already divided enough. And when it comes to Leucovorin, again, this is a great thing. This is a potential treatment for autism. They're not promising it's going to cure all autism, but just to have the conversation around it, that's really important. I will tell you, I walked away from that press conference very disheartened, very disappointed. I think there's a lot of great things happening in the White House and the HHS right now. I think that the messaging is crucial and I think that they're failing miserably at the messaging. And it's not that they're failing because we all know how President Trump is and why people vote for him is because they trust him to just say what he's thinking, not be reserved and not bend to anyone else. I get that. And by the way, that's one of the things I like about him too. My concern is that these are very complicated topics. Lives are on the lines and nuance really matters. And I think it is really important to have strong messaging that is fact based and that's delivered in an understandable manner when you're going to have these conversations. And I think that unfortunately that press conference failed to do pretty much all of that, even though the messaging was strong, as demonstrated by my EX account immediately following the the press conference, if I say anything that goes against or even gently criticizes the administration, people automatically think that, oh, I am anti Trump, anti RFK Jr. You know, anti Maga, anti Maha. But the reality is I am pro human, I am pro Americans, I am proud of healthy living, pro science, pro whatever it is that you want it to be. And the only way for me to be honest with myself and with those who are listening to me is to push back when I see it. I will always criticize when I think something is handled incorrectly. That doesn't mean that I think that I'm perfect. I mess up all the times. I mean, look at what happened through Covid. I got some stuff wrong. I got a lot right. And when I was speaking out against people, I got criticized then too. So I'm okay being criticized. As long as I know that what I am saying is fact based, then your criticism can be whatever it is you want it to be. I think that the message from the White House about using Tylenol sparingly in pregnancy is a great thing. The messaging failed. I think having the conversation about hepatitis B vaccines being risk based and potentially not having it be a birth dose, I think that's a great conversation. The messaging has failed. The MMR plus V vaccines. I think it's a good thing to separate them. ACIP did too, which is why they did it 10 years ago. The messaging has failed. I think that when it comes to public health, messaging is crucial. It's just as crucial as the science that it's supposed to be communicating. And that's what I ask for this administration is to focus on the messaging. Focus on someone who can get in front of the camera, who can take what's being done behind the scenes and communicate it in an effective way that decreases the amount of fear and decreases the amount of confusion. That's all I'm asking. Thanks for listening to Wellness unmassed on America's number one podcast network, iHeart. Follow Wellness unmasked with Dr. Nicole Safire and start listening on the free iHeartradio app or wherever you get your podcasts. And we will catch you next time.
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Episode Date: September 23, 2025
Host: Dr. Nicole Saphier
Podcast Network: iHeartPodcasts
In this episode, Dr. Nicole Saphier dives into the recent shake-ups in vaccine recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) and the notable White House press conference featuring President Trump and top health officials. Dr. Saphier breaks down rationales behind new vaccine guidelines (including MMR/varicella, hepatitis B, and COVID-19 vaccines), addresses the ongoing debate around acetaminophen (Tylenol) and autism, and critically examines public health messaging during these turbulent times. The episode is marked by her straightforward, nuanced tone, aiming to clarify both the science and the spin for listeners.
“People sometimes get mad at me because they feel like I'm not a loyalist, whether one way or the other. ... my role as a physician, as a human, as an American is to ... make some sense of all this mess.” (03:28)
“If we can avoid a risk of seizures, we should be doing it.” (05:09)
“The reality is you can't [make a recommendation without solid data], which is why they decided not to.” (07:58)
“Anyone ... considering the vaccine should have a conversation with their doctor about the risks and benefits.” (11:20)
“Correlation does not mean causation ... They have not actually figured out what is the cause.” (13:40)
“Marty Makary said that they were able to find a causal link. But I have to be honest with you, if you read the study, no, they didn’t ... observational limitations preclude definitive causation.” (19:47)
“When women have fever in pregnancy, they have up to a 40% risk of a child with neurodegenerative disorder. … That is significantly higher than any risk ... reported using acetaminophen.” (22:47)
“So at least half the children are going to have access to it and have it be covered. I'm sure private insurers will follow suit.” (30:59)
“These are very complicated topics. Lives are on the lines and nuance really matters. ... It's really important to have strong messaging that is fact based and that's delivered in an understandable manner when you're going to have these conversations.” (34:38)
“I am pro human, I am pro Americans, I am proud of healthy living, pro science ... The only way for me to be honest with myself and those who are listening ... is to push back when I see it.” (35:54)
“Public health messaging is crucial. It's just as crucial as the science that it's supposed to be communicating.” (36:34)
Dr. Nicole Saphier delivers a deeply informed, forthright analysis of shifting CDC/ACIP vaccine guidelines and the fraught intersection of science, communication, and politics, calling for evidence-based, nuanced public health messaging in an era of heightened confusion and mistrust.
For listeners seeking clarity on recent vaccine updates, autism controversies, and the art of public health messaging, this episode offers a thoughtful, expert, and refreshingly honest perspective.