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Kal Penn
Hey audiobook lovers. I'm Kal Penn.
Ed Helms
I'm Ed Helms.
Kal Penn
Ed and I are inviting you to join the best sounding book club you've ever heard with our new podcast, Earsay, the Audible and iHeart Audiobook Club.
Ed Helms
Each week we sit down with your favorite iHeart podcast hosts and some very special guests to discuss the latest and greatest audiobooks from audible.
Kal Penn
Listen to Earsay on America's number one podcast network, iHeart. Follow Earsay and start listening on the free iHeartradio app today.
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Dr. Nicole Safire
Foreign. Welcome to Wellness on Mass. I'm Dr. Nicole Safire and I'm sitting down this morning doing this podcast, having my morning cup of coffee because it is like a wintry snowy mix outside. So it's like a delayed opening for the kids school. So it's a little bit of a late start today. So let's have our coffee together, shall we? Big News. It's now December 2nd, and I have decided to do a personal challenge for December while I'm taking a sip. Big personal challenge for December. You know, we all wait until January to come up with, like, our New Year's resolutions. What are we going to do? How are we going to get in shape? How are we going to be a better version of ourselves in the new year? I decided I want to do it in December this year. So here's what I'm doing. So for December, starting yesterday, I'm increasing the amount of workouts I do. So my goal is to do 20 workouts in December. Now, I know for people who work out five, six times a week, that doesn't sound like a lot. Twenty workouts in a month. But when you have holiday parties, you have Christmas and Hanukkah and all this stuff at the kids schools, December can be very busy. And one of the first things to go are the workout. So by having a little checklist, making sure that I'm getting 20 for the month, that's how I'm focusing on my physical health. I'm also taking a bit of a step back from social media. Ach, I know. Um, how am I going to do this? I'm not sure my voice is going to come and go throughout this, but, you know, it'll still be great. So I have decided I want to get rid of social media from my phone because it's so easy to just when you have a couple minutes during the day, you just go on your phone and you start scrolling, scrolling, scrolling. Well, do you know that actually affects your brain chemistry? They do studies looking at functional MRI and it shows activity in your brain changes as you engage in social media and it also elicits dopamine response. Which is why if you do a post and you get likes and comments and it's going, it's doing really well, that actually gives your brain a reward and that's why you feel good about it. But the alternative is also true. If you do a post and for whatever reason, people aren't seeing it, aren't. Liking causes negative emotions and feelings, which is why social media use is linked to anxiety and depression and all of these other things social. So my Mental health heading into the holiday season, I want to cut back now. It's a little bit tricky to cut back on social media when you have like a media presence. You know, I go on tv, I'm doing this podcast, I have a wellness company, all of these things I use social media for so for business. But that doesn't mean that it is still good for my mental health. So it's not going to be black and white. I'm not completely off of social media. In fact, you may be listening to this podcast because I posted it on social media, but you're not going to see me as active on social media as maybe I usually am. And that's just me making a conscious effort to focus on more meaningful things like real life personal interactions or, you know, doing more with my work because I actually find enjoyment in my work or focusing on other hobbies. I'm actually in the process of writing a book right now. If I have five minutes, instead of doom scrolling on social media, maybe I should be focusing on that book and so some other things like that. So I'm heading into the New Year already focusing on my physical health, on my mental health. So by the time New Year's resolution Conversations comes around, I don't have to be like, ah, crap, what diet am I going to do this year? Nope, because I'm already going to be feeling good mentally and physically. So maybe for my 2026 New Year's resolutions, I can focus on bettering someone else. Like, what can I do for other people? Because I've already spent December focusing on myself. So that's my goal. I encourage everyone to do it with me. Doesn't mean you have to do the same things I'm doing. But maybe let's try in December to get us to a good place so that when we head into the holidays and we head into our New Year's resolutions, we already are feeling pretty good. And so then we can focus on how can we help others around us. So I know that sounded like a lot of this topic, but that's not what I want to get into today on wellness. Unmask if you've been on social media, because that's where a lot of this happens. You will see something pretty big happened last Friday afternoon. Now, a lot of things get buried in the news cycle when they occur on Friday afternoon, but this one was pretty interesting and it's hit a nerve with a lot of people. And to be honest, it probably should. So there was a leaked FDA internal memo. Now, whether or not it was actually leaked. I don't know. I think it sounds like a pretty intentional leak. If you send out a memo on a Friday afternoon, Friday after Thanksgiving afternoon, you send it out to like over a thousand people in, you know, an industry, do you really think that that's going to stay internal? Probably not. And if you actually read this internal memo, it doesn't necessarily read as something that was meant to stay internalized. So what was this memo? Well, it was a memo from the head of one of the interdepartmental agencies within the FDA claiming that at least 10, 10 children deaths were likely linked to the COVID vaccine through probably vaccine associated myocarditis. Although they didn't necessarily come down by it. But what they said was they looked at the VAERS data, which VAERS is a public forum, it's an online thing that anyone can go to. You can be a patient, you can be a parent, you can be a doctor, you can be a drug company. If you have a side effect from a medication, a vaccine, if you, you're able to input it, if you feel that the side effect is from that. Now there's a huge caveat when you're looking at the VAERS data. So I can go on. If I take a medication and something happens to me in the next couple of weeks or even a couple of months and I'm like, you know what it was? It was probably that vaccine. I can go input that. Now other people can read what I put down. And so they may automatically think, oh my gosh, this person had this and she said it was from this. But that's not necessarily true. Right. So just because I think it is doesn't mean it was. Maybe I had an underlying viral infection that caused something. The reality is this is just people inputting data, but this is not verified data yet. So a couple of months ago, people at the FDA said that they are putting together a working group that they were actually going to go through the VAERS data. They were going to actually look at those who said that they had side effects from the COVID vaccine and they wanted to look at that and say were they really from the vaccine? Now the numbers that were in VAERS, there were 96 supposed deaths from the COVID vaccine. That's how many were reported. This internal memo says that they've gone through all of them and they say at least 10 they believe are likely linked to the COVID vaccine. So that's pretty big news. And this memo, again, it comes from inside the FDA center for Biologics Evaluation and Research, which is essentially the vaccine regulating arm of the agency. And so 10 of those deaths in children age 7 to 16 were considered, quote, unquote, likely or possibly related to myocarditis after vaccination. Now, on its face, that's obviously very serious, but I want to take a pause before we jump to conclusions. This memo itself is not peer reviewed. And while I think it is incredibly important and excellent that they decided to go through all of this VAERS data, because there are a lot of people out there who have been criticizing Covid vaccines, who have been saying that they have been underreporting the safety data. And by the way, I'm one of those people. I also think that they were underreporting safety data when it came to the COVID vaccine. So I was very happy to see that they were doing a deep dive into the VAERS data. But just because they're now coming out saying, well, we looked at it and we think at least 10 of these deaths are related. They did not, in this quote, unquote leaked memo, they did not put forth any evidence as to, or any criterion as to why they believe those 10 deaths were linked to the vaccine. So what does that do? Immediately? It's one opinion to another opinion. The people who put the information into vaers, that's their opinion that the death was related to the vaccine. Now we have this internal memo where the FDA is saying, well, we believe at least 10 of these deaths are related. That's another opinion because they didn't produce any data to back up that opinion. So right now we have a statement, but without the data needed to verify it, especially if we want people to take it seriously, we already know Trump Derangement Syndrome is a real entity in the sense that anything that comes out of the current hhs, fda, White House, anything that's associated with President Trump, Secretary Kennedy, people are going to automatically reject just because of the underlying bias that they, whatever they do, has to be wrong, even if they're right. So if they're going to make a statement like the vaccine, they're acknowledging that the vaccine likely killed at least 10 children. That's a heavy statement to make without putting forth data because immediately they're going to be scrutinized by every academic, every media outlet. And that's exactly what happened over the weekend. So this leaked memo happened Friday afternoon. You had FDA director Marty McCary was up bright and early on Fox and Friends Saturday morning. So that's again, memo came out Friday afternoon, media hit Saturday morning. And it Seemed very, I mean, McCary does a great job on TV, but he definitely had his talking points. And so it did seem like some of this was a little bit intentional. And he essentially said something that he's been saying for the last year, that this new FDA is not going to be rubber stamping vaccines just because it was approved in the past, just because of the way things were done in the past. They are not going to continue to do this. And they want rigorous safety data. I don't think anyone can argue with that, although they're going to try. But the problem that I have with the way that this leaked memo rolled out was again, it was a memo, it's in the guise of it being now a leaked memo and there was no data to back it up. They, as far as we know, they're not, they haven't printed it in a peer reviewed journal to show why they believe that these deaths were linked. And so it's just kind of out there. And when it's out there like that, it kind of gets caught up in the weeds of conspiracy theorists. Even if they're right by the way. Again, I personally believe that the Biden administration, the prior cdc, the pharmaceutical companies were under representing safety signals when it came to these Covid vaccines, even Moderna in one of their, in their booster trial. A child died in that booster trial. It took a while for them to actually acknowledge it because they kept manipulating the data in such that they didn't have to report that child's death. And this is why pharmaceutical companies have a bad rap with the American people, because they do such as this. But the goes both ways. You can't make a statement without having data. Because if you just manipulate words to promulgate fear and incite anger and other emotions without having the data, you know, you're no better off. And that's where we're standing, that's where we're at right now. We had this leak memo that was full of what at this point, opinion without data backing it up. And I think, you know, it's just as harmful as the pharmaceutical companies who are hiding some of the data. So, you know, going back to when these vaccines rolled out, I just want to tell you my own personal opinion. I mean, Operation Warp Speed was probably one of the most incredible things that I had ever seen. The fact that President Trump was able to harness his business mindset to really work with researchers, academics and pharmaceutical companies to get a vaccine available, you know, within a year, that's a huge deal. Especially when you look at how long it takes for drugs to be researched, manufactured, and brought to market. It's like anywhere from seven to ten years on average. And no, that's not because we do such rigorous safety data. It's more because we have a lot of red tape and bureaucratic bloat that prolongs that. So President Trump was able to cut through a lot of that. So when it rolled out and all of the initial data that showed that, yes, it was able to incite an immune response, which is the ultimate goal of vaccines. So in theory, that should decrease severity and hopefully should stop transmission of the virus or at least decrease it. Obviously, I don't need to rehash what happened. So. So a lot of people got the vaccines whether you're mandated to or not. And we did see dramatic decrease in hospitalizations and deaths. The current FDA director, Dr. Makary, just this Saturday reconfirmed that when you look at the data, especially in the early days of COVID the vaccines were directly linked to remarkable decrease in severity of illness, especially in older populations and vulnerable populations. So that's undisputed. Now, fast forward to when they started expanding the vaccines for kids. Teenagers, young adults, kids zero through, I don't know, 30. That's when I started to say, pump the brakes a little bit, because I had three kids ranging from elementary school to college, and I had already seen them all have Covid at that point, probably a couple times, to be honest. And the overwhelming data told us that they were the lowest risk for severe illness. One thing that was concern in kids was the MIS C, that multi inflammatory syndrome in children, which was essentially an autoimmune and an inflammatory response that the body did in reaction to the virus. And that was, that was pretty bad in kids. Now, those inflammatory type responses can happen with a lot of viruses. It wasn't specific to Covid, but we did see it with COVID in kids. So my concern was, if we're concerned that kids have this high inflammatory response to this virus, are they going to have that same same inflammatory response to the vaccine? And don't forget, the vaccine we give tends to be a higher antigen load, too. So is it going to actually incite a higher likelihood of having this inflammatory response? This was my biggest concern. And in fact, I wrote about it many times on Fox Digital. I reached out to my friend and colleague, Dr. Marty Makary, who is now the FDA administrator. I mean, he's, he's doing great things, but he was one of the people I talked to about my concerns. And funny enough, you Know, he put me in touch with a lot of people. So I've met Memorial Sloan Kettering, he was at Johns Hopkins. Obviously these are big name institutions. He put me in touch with some people that he knew regarding pediatrics so I could ask my questions because I had huge concerns about the vaccine causing an inflammatory reaction in kids. They all kind of talked the line of, you know, pediatrics and fell in line with the American Academy of Pediatrics of no, no, no, it's much safer to have an inflammatory response to the vaccine than the virus. The virus is unpredictable, blah, blah, blah. Listen, I get it, that makes sense. But I was seeing how little this virus was affecting school age and adolescent kids. And I had a huge concern about introducing this vaccine to them when I saw what little inflammatory response they actually had to the virus. And as we knew as time was going on, the virus was weakening, so they were having a less and less inflammatory response. So were we really going to now give them this vaccine and to try and incite inflammation? It seemed concerning to me. Makary and I actually wrote a piece in the Wall Street Journal looking at that Pfizer data on kids. And the star of the paper is, was very different than what it actually turned out to be. And I'll be honest, I was very disappointed with the end result of that paper. My overarching theme was whether you let your child. We're talking about healthy kids, obviously at this point I'm not talking about the children with chronic illness that may put them at higher risk. I'm talking about the, you know, the overall healthy child. You know, when I wrote, was started writing this Wall Street Journal piece, I wanted to essentially put out there, the risk of COVID to your child is very low when it comes to the vaccine. It's probably also low risk to give your child a vaccine. But the question is, is it actually necessary? Does the vaccine prove a benefit over that low risk? And for me, it hadn't yet there hadn't been data to show that, that that vaccine caused a benefit over the risk. After many, many iterations of that paper, Makary, myself, the editor of Wall Street Journal, it ended up just coming back saying whether you, your kid gets Covid or has the vaccine, it's low risk. It's up to you. So it kind of just stayed on this line, this middle ground. I wanted to take a little bit stronger of a stance saying I wasn't convinced of the benefits of the vaccine. But you know, sometimes you have to give a take and I wasn't the sole author, so I couldn't necessarily do that. So I've always had concerns about the vaccine and kids hearing the FDA right now saying that they're looking at it again and going back a little bit more, it's clear that myocarditis in specifically adolescent boys is a very real risk factor. It absolutely is. It was well documented in Israel before we even saw the safety signals here in the United States. And here in our own data, it shows that there is a much higher risk of myocarditis in adolescent boys than any other age group or demographic. So for me, the question is, should there be a black box warning about this vaccine and it's specifically in that age and demographics? Probably. I have a feeling one's going to come, especially after some of the reviews right now. I think that's a good idea. You're listening to Wellness Unmass. We'll be right back with more Your.
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Kal Penn
Hey audiobook lovers. This week on the podcast I'm sitting down with musician, producer and walking encyclopedia Questlove. We're talking about Mark Ronson's memoir Night how to be a DJ in 90s New York City. All right, like we talked about before, Mark Ronson found sanctuary in the DJ booth. What's a tool or piece of equipment in the studio or on stage that gives you the most control?
Ed Helms
So I have two microphones on stage. We have the microphone that you hear as the audience. Then we have a second microphone in which we communicate with each other. I feel like that second microphone kind of saved all of our friendships. No band likes each other after 20 years years or 25 years. Like the Beatles broke up in seven and a half years and we're going on 35.
Kal Penn
Listen to ear, say the Audible and iHeart audiobook club on the iHeartradio app or wherever you get your podcasts.
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Dr. Nicole Safire
I also like the fact that the fda, the cdc, the acip, they have said Covid vaccines and the annual boosters probably are not necessary for everyone. There's no data to actually show that a healthy child, especially a healthy young male teenager, benefits from getting an annual Covid booster. The COVID virus continues to mutate it continues to get. Yes, it is more contagious, it's going around and round and round, but it's also a much more mild virus where the risk with the vaccines are real, especially in healthy young kids. So. So they have not proven a large benefit, in my opinion. And it seems like the current FDA is also coming to that same conclusion. I really agree with a lot that the FDA is doing when it comes to the COVID vaccines. They're still saying they're available. They're specifically available to those who where there is an absolute documented benefit. Older adults, people who have chronic illness, putting them at an increased risk of severe disease, and anyone else who wants it, there is still availability for it. So I think these are all a good thing. What I don't like is what just happened on Friday with this leaked memo. 10 children died. It's like, whoa, what? Hold on a second. This is huge News. If the FDA is saying 10 children died from the COVID vaccine and the FDA and the pharmaceutical companies have not current have not previously said this or admitted this, that's a big deal, and it shouldn't have been thrown at the American public the day after Thanksgiving in a, quote, unquote, leaked memo. It's not the right way to do it. You know, delivery matters. I think I've said that at nazm with this administration right now, I support a lot of what's going on there. But delivery matters if you actually want people to support it and if you actually want it to last beyond this administration, because that's the ultimate goal, right? It's not just, what can we jam pack in four years while President Trump is in the White House just for it all to be upended and undone when someone else comes into the White House? That can't happen. People deserve so much better. Public health deserves so much better. We have such a ways to go from what happened during COVID And while we're doing a lot of good things right now, how we are communicating it, how we're delivering it matters. And so that's the only thing that I have to say is we have to ignore some of these headlines, people. Probably why I'm getting off social media a little bit in December, because it really does incite a lot of emotions that are not good for us. At the end of the day, it's great that the FDA is looking at vaers. It's great that they are considering more rigorous trials and looking at the data when it comes to our annual vaccine recommendations, whether it's the COVID Vaccine, whether it's the flu vaccines. I mean, the reason they're able to quote so many people get the flu vaccine is because it's mandated amongst a lot of schools and all hospitals. I mean, you have to get it in hospitals. What happened as soon as you took away the COVID mandate from hospitals? Healthcare workers didn't get the COVID booster. The reason healthcare workers still get the flu booster flu shot is because they have to. What would happen if you took away that mandate? I guarantee a lot of hospital workers would stop getting it because there's already a huge question as to what the efficacy is of the flu shot at reducing transmission. Just like Covid, we know it reduces severe illness and hospitalization, but the effects on whether it actually reduces significantly at a population level transmission hasn't been proven. And that these are the questions that the FDA is bringing up saying, should the CDC be having these conversations? Should we make sure that these vaccines are doing what we say that they do? We do a lot of lab studies, we do a lot of epidemiological studies looking at stuff, but we're not actually proving it, we're just saying, well, these are estimates, these are what we think happens. And because this is what we think happens, therefore you have to do it. And I think we're kind of moved past that. Unfortunately, Covid has actually, fortunately, not unfortunately, but fortunately, Covid has woken a lot of people up saying, just because you say this is right doesn't necessarily mean it is. Now, that being said, we obviously can see the benefits of certain vaccines. We had measles eradicated here in the United States because we had such high level population vaccination rates of measles. Now all of a sudden we are at jeopardy of losing the eradication state because we have so many cases of measles now because of community spread and low vaccination rates. So we know that there are some benefits to vaccinations. We know that there's huge benefits to population level vaccination rates. But not all vaccines are created equally and they don't all have the same benefits. And so it is important that we break it up a little bit this week. The acip, that's the kind of the vaccine recommendation group, the cdc, they're meeting Thursday and Friday and it's going to be, it's going to be a blockbuster week. I'll definitely talk to you about it on Friday's rundown. They're talking about the whole vaccine schedule. President Trump has made some comments about maybe breaking up the vaccine schedule instead of giving someone an MMR like measles, mumps and rubella, maybe breaking them up. So you just get measles one visit, maybe you get rubella the other visit. Personally, that sounds like a logistical nightmare from a pediatrician and a parent's standpoint. And I also don't know if the drug makers are willing to go back to the drawing board and reformulate all of these vaccines. So they're going to have to talk about that. And I hope that they keep some of these things in mind when they make these recommendations. Just because you want something doesn't mean it's possible. Also, all Day Friday is scheduled to talk about the Hepatitis B vaccine in newborns. They were supposed to vote on that a couple of months ago, but it got scrapped. So that's going to be a heated conversation. I will definitely bring you everything on Friday's weekly rundown because you know it's going to be interesting. And I'll be watching it live because I won't be following it on social media, even though I probably will tap into social media a little bit just to see what people are saying. Like I said, my December challenge is not black and white, but I have to kind of stay active. I want to know what people are saying. So that's it for today. I hope you have a wonderful week. I hope you join me in our December challenge for physical and mental fitness. I need to take my kids to school, I need to do some work and I have to get my butt on the peloton because I have to get that workout in today. Thank you so much for listening. Welcome to Wellness on Mass. I'm Dr. Nicole Safire. Make sure you tune in to iHeartRadio wherever you get your podcast and I'll see you next time.
Kal Penn
Hey audiobook lovers, I'm Cal Penn.
Ed Helms
I'm Ed Helms.
Kal Penn
Ed and I are inviting you to join the best sounding book club you've ever heard with our new podcast, Irsay The Audible and iHeart Audiobook Club.
Ed Helms
Each week we sit down with your favorite iHeartra podcast hosts and some very special guests to discuss the latest and greatest audiobooks from Audible.
Kal Penn
Listen to hearsay on America's number one podcast network, iHeart. Follow earsay and start listening on the free iHeartradio app today.
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This episode, hosted by Dr. Nicole Saphier, centers on two intertwined themes: personal wellness resets ahead of the new year, and a deeply discussed controversy surrounding an FDA internal memo about COVID-19 vaccine safety in children. Dr. Saphier weaves together her December health challenge with an in-depth and critical review of the leaked FDA memo, sharing both personal experience and policy insights, especially as they pertain to vaccine safety, risk, and communication in the US public health system.
Dr. Saphier’s Personal Challenge:
She’s beginning her “New Year” improvements a month early, committing to 20 workouts in December and reducing her social media use to focus on mental health, quality work, and personal passions.
Mental Health Nuances:
She acknowledges the challenge of going off social media when having a public profile and stresses moderation and intentionality over complete withdrawal.
A Shift Toward Others in the New Year:
Encouragement for Listeners:
She invites everyone to join her in a customized December reset, aiming to start the new year already feeling good, and thus able to help others.
Background of the Memo:
VAERS Data: Caveats and Challenges:
Critical Appraisal of the Memo:
FDA Communication and Public Trust:
Reflections on Operation Warp Speed and Policy Efficacy:
Personal Experience and Published Concerns:
Call for Better Warnings:
Changing Recommendations:
On Risk, Mandates, and Individual Choice:
Vaccine Communication Strategy:
Upcoming ACIP (CDC Vaccine Committee) Meetings:
Cautions Against Blanket Approaches:
On Social Media and Dopamine:
On FDA Data Disclosures:
On Operation Warp Speed:
On Pediatric Vaccines:
On Moving Beyond Compliance Culture:
Dr. Nicole Saphier skillfully combines personal health advocacy with substantive analysis of a national vaccine safety controversy. She highlights the need for personal wellness, skepticism balanced with scientific rigor, and clear, responsible communication from public health authorities. Her episode encourages both a critical eye and personal agency in navigating the ongoing changes in medical transparency and vaccine recommendations.
End of Summary.