The Many Ways Music Affects Your Brain & How Safe and Effective Are Your Meds?

Which side is your good side? You know, the side of your face you point toward the camera when someone takes your picture. We all have a good side. And I bet I know which one yours is. https://newsfeed.time.com/2012/04/24/which-side-is-your-good-side-here-comes-the-science/ You are exposed to a lot of music every day. Sometimes it is music you seek out and want to listen to as well as music that plays in the background – in stores, in elevators, in a doctor’s office. All that music affects your brain in interesting ways. Here to explain how is Sara Leila Sherman. She is a musician and educator, who studied and pioneered innovation in music as a tool for learning and personal growth. She is coauthor of the book Resonant Minds: The Transformative Power of Music, One Note at a Time (https://amzn.to/4jDM6Aq). Many prescription drugs do amazing things to help people. Still, there are frequent stories of drugs that go wrong. They either don’t work or they turn out to cause harm or even death. Isn’t the FDA supposed to make sure that doesn’t happen? How do bad drugs get approved? Is the process broken? Here to offer some great insight into this is Jerry Avorn, MD. Who is also a professor of medicine at Harvard Medical School. He created a leading research center at Harvard to study medication use, outcomes, costs, and policies and has written hundreds of papers that have appeared in medical literature as well as opinion pieces in The New York Times and The Washington Post. He is author of the book Rethinking Medications: Truth, Power, and the Drugs You Take (https://amzn.to/4lRlT2E) Many people look back fondly on the good old days. Were they really that good? For some, the past seems so much better than the present, and they love to reminisce fondly about a better and simpler time. Listen as I explain why the past looks so wonderful to many of us and just how good it really was. https://www.elephantjournal.com/2014/08/why-we-long-for-the-good-old-days-why-they-never-really-existed-marianne-stenger/ PLEASE SUPPORT OUR SPONSORS!!! FACTOR: Eat smart with Factor! Get 50% off at ⁠⁠https://FactorMeals.com/something50off⁠⁠ TIMELINE: Get 10% off your order of Mitopure! Go to ⁠⁠https://Timeline.com/SOMETHING⁠⁠ INDEED: Get a $75 sponsored job credit to get your jobs more visibility at ⁠⁠https://Indeed.com/SOMETHING⁠⁠ right now! QUINCE: Elevate your shopping with Quince! Go to ⁠https://Quince.com/sysk⁠ for free shipping on your order and 365 day returns! SHOPIFY: Nobody does selling better than Shopify! Sign up for a $1 per-month trial period at⁠⁠ https://Shopify.com/sysk⁠⁠ and upgrade your selling today! Learn more about your ad choices. Visit megaphone.fm/adchoices

Speaker names marked ? are inferred from speaking time and the show’s known hosts — they are not voice-verified.

• 0:00Mike Carruthers?

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• 1:27Mike Carruthers?

  Today on Something You Should Know, which side of your face is your good side? Are you sure? Then, you're exposed to more music every day than you think, and all that music affects you.

• 1:41Speaker 01

  Different types of music do different types of things for us. Our brain start firing our neurons 300 to 500 milliseconds after it's exposed to music. So that's faster than we have a conscious thought, or before we can even recognize the melody.

• 1:56Mike Carruthers?

  Also, why do the good old days seem so much better than the present? And the prescription drugs you take? You'd like to think they've been tested by the FDA?

• 2:07Speaker 02

  Many people, including a lot of doctors, think that the FDA tests drugs. It doesn't. It doesn't test any drugs. It relies on studies that are submitted to it. Often, the manufacturer will set up those studies in a way that will put the drug in the most favorable light.

• 2:22Mike Carruthers?

  All this today on Something You Should Know.

• 2:27Mike Carruthers?

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• 4:23Mike Carruthers?

  So do you know which side of your face is your good side? The one you like to point towards the camera when someone's taking your picture? Hi, and welcome to this episode of Something You Should Know. If you've never taken the time to really determine which side of your face is the good side, I can tell you that it's probably the left side. Researchers from Wake Forest University studied the faces of male and female college students and took note of their personal preferences, and they almost always said the left side. The researchers say there's a reason most of us are drawn to the left side. That side of the face is controlled by the right side of the brain, which governs feelings.

• 5:07Mike Carruthers?

  As a result, the left side of your face will usually show a greater intensity of emotion. This is also a difference that painters have seemingly known about for centuries. Go to any museum, and you will notice most portraits depict a person's left side. And that is something you should know. Whether you realize it or not, music plays a role in your life. You hear music more than you think. Get in your car, go to the store, go to the mall, go to the doctor's office, watch TV, go to the movies. There will be music playing in all those cases.

• 5:48Mike Carruthers?

  And then there is the music that you intentionally listen to because you enjoy it. Well, what effect does all this music have on you? And can you use music in an intentional way to actually help you to improve your life? Or maybe music is just something pleasant to listen to to fill up the silence? Well, I think what you're about to hear about music and how it affects you is going to surprise you. My guest is Sarah Leila Sherman. She is a musician and educator who has pioneered innovative approaches to use music as a tool for mindful learning and personal growth. She's co-author of a book called Resonant Minds: The Transformative Power of Music One Note at a Time.

• 6:33Mike Carruthers?

  Hi, Sarah. Welcome to Something You Should Know.

• 6:36Speaker 01

  Hi, Mike. Thank you for having me.

• 6:38Mike Carruthers?

  So let's start with how much music do we hear? How much do we listen to?

• 6:43Speaker 01

  Seventy percent of Americans listen to music for three to four hours a day. So then when we think of music and how much we're consuming music anyway, that's a lot of hours. But the idea of intentionally using music to help with our focus, our cognitive functions, our emotional awareness, community building, we don't necessarily put the thought into that in our everyday lives. And so that's what I love talking about is how we can intentionally use music as that tool to bring presence into our everyday lives.

• 7:17Mike Carruthers?

  So when I hear you say using music in an intentional way, I think of the music like, you know, when you listen to those meditation tapes and there's, you know, the, the, whatever that fluty sound is. And that, to me, that's music for that. That's, but I don't know what that music is. I have no interest in listening to it any other time in my life. That's just, you know, music to be mindful by. But give me, can you give me an example of using music in an intentional way?

• 7:49Speaker 01

  Absolutely, but I have to ask, do you like that music? Or do you find, you know, the idea of the masseuse and the waterfall and the flute music, to me, that doesn't resonate with me. So it's almost makes me a little anxious instead of relaxed. Do you actually find that you are more relaxed when you hear that type of music in that setting?

• 8:08Mike Carruthers?

  It's a good question, but it's almost as if, if the music wasn't there, I'd think something's wrong. This person doesn't know what they're doing because they're not playing the mandatory flute music that I so expect to hear.

• 8:21Speaker 01

  Okay, so I'm going to answer your question. And then you just spurred something else that I love talking about as music, as a cue in the absence of music and what that does to our brains. But so it's not always waterfalls and flutes. Different types of music do different types of things for us. Our brain start. Firing our neurons 300 to 500 milliseconds after it's exposed to music. So that's faster than we have a conscious thought or before we can even recognize the melody. And what it does, it goes through our auditory cortex to our amygdala, so where we process emotions. So you're right that it makes you feel something, but it doesn't just have to be that because music can help lower our blood pressure and our cortisol levels, and maybe it's Bach.

• 9:03Speaker 01

  And in terms of reducing our stress levels and our cortisol, it usually is something with slower beats per minute, usually less than 80 beats per minute, and long melodies, and not words. Words tend to actually interfere.

• 9:17Mike Carruthers?

  But context seems to play an important role in it. And, and, you know, for example, going back to the masseuse and the meditation music and all that. So if you walk into the masseuse's place and, you know, the candles are burning and the lights are flickering or whatever, and, you know, and she puts on Def Leppard instead of the fluty, you know, waterfall music. Even if I like Def Leppard, this is not the place.

• 9:43Speaker 01

  Well, absolutely. Def Leppard is then music to motivate or to have a different sight of our emotions activated. When we listen to different types of music, it interacts with our amygdala in different ways. So there is a part of our brain that has that section for focus and for kind of this calm music. And I think that's what you're talking about there. But then this other music ignites something called a groove. And a groove isn't just something that we think about when we're, you know, at a concert or a mosh pit. A groove is actually a neurological term when our brainwaves are synchronizing. So if you think back to a concert or whatever it might be, or Def Leppard, when you're in a room with people listening to music that has usually 80 to 120 beats per minute,

• 10:27Speaker 01

  which I imagine Def Leppard does, and it's usually most popular music, and it's the same amount of beats that most of us walk to, so the rhythm of our feet. Our brainwaves synchronize with each other, which creates a sense of community. And it also has this way then of getting in touch with us emotionally. So whatever type of emotion Def Leppard is bringing to you, I imagine that upbeat, that energized, it's not that. Flute masseuse music, it has a point and it has a purpose. And so it's about figuring out what music has a purpose in our lives and how we want to use it at a time to ignite that purpose that we're looking for in that moment.

• 11:06Mike Carruthers?

  I was surprised by your statistic that, I think you said 70% of people listen to three to four hours of music per day. That seems like a lot.

• 11:18Speaker 01

  It is a lot, but it's also the idea that music is often on in the backgrounds or what we think of music on as background music. Or today's world scrolling and social media and the numbers are actually higher for younger kids, for teenagers in particular, where it's eight to nine hours of media consumption a day. And how much of that media consumption is involved with music? Think back to what you were saying, if the music turns off, what's wrong here? What's happening? And that's actually like hold music. That was the rant I was going to go on before about hold music. Where when we're on hold somewhere, we anticipate music. And when it's not there as this cue, we think we've been hung up on. So we're so ingrained to have music be a part of our everyday lives, whether it's

• 12:03Speaker 01

  in an elevator, in a store. And so with that three to four hours, if we even take just 20 to 30 minutes, even less, two to three songs a day and say, hey, I'm going to attach this song to focus. Or especially if you're a family and you have young kids, it works really well to have songs be cues. Hey, when we play this song, it's going to signal shoes and socks on jackets on and let's go out the door. And so those songs can, again, through that repetition, become this cue. And the three to four hours then is not just in the background, which music never really is background, because like I mentioned, our neurons are firing purposefully according to the music, whether we realize it or not.

• 12:45Speaker 01

  That's why if you're writing, it might be harder to write when you're listening to music with words. It might be harder to focus if you're listening to Death Leopard versus classical music. And so that three to four hours is really staggering, but let's put some of that intention behind it.

• 13:01Mike Carruthers?

  You know what I really hate is the hold music. You know, when they put you on hold for 20 minutes, but they play the same 30 second loop of music over and over and over again. Knowing they know you're going to be there for 20 minutes. That is maddening. I would, I would rather have silence than hear that thing for the 400th time.

• 13:24Speaker 01

  So in the 1960s, this is one of my favorite stories. You know, it's switchboard operators. And the story of hold music on phones happened because a switchboard operator accidentally crossed the cable with the local radio show. And so the person on the phone was all of a sudden hearing the radio instead of being switched to where they were supposed to go. And so all of a sudden, the hold music was patented in the 1960s. It still is under the same patent. And it's really become this signal now in our everyday lives of hold. You know, there's a 1989, there is Cisco Hold Music. It's one of the most famous pieces of hold music out there. That's probably what you've heard on repeat.

• 14:05Speaker 01

  But there's all this research behind the type of hold music that certain businesses pick. You know, if you're on it with an insurance company, they might select types of music like we mentioned to lower your stress levels of your, or your cortisol. So I agree. I don't love hold music, but it's a signal because if you were met with silence, how would you know if somebody hung up on you or if you were disconnected from the call?

• 14:28Mike Carruthers?

  Right, yeah, that it very much serves as that. We're still here. We're just ignoring you at the moment, but we're still here. And you say in your book that only 1.4% of people listen to classical music. That's surprising.

• 14:46Speaker 01

  In the world. So there are different statistics. The numbers are higher if you look at the UK and in Canada and America, but globally, which I think is important to look at. I think that there's been this shift of classical music. If we can go back to Mozart. Mozart's concerts were.

• 15:04Speaker 01

  For lack of better words, let's say raucous, where people cheered if they really loved this crescendo, which means the music gets louder and they would cheer. And he expected that. We have letters of Mozart writing to people and saying, "They applauded just like I knew they would." And then when it got really soft, I could hear silence and like I wanted. And they were so excited at the end of this part that they applauded. And he was not against this type of interaction with the classical music. In fact, it was a social event. It was expected. And the way classical music is often presented today, here's a sonata, here's a symphony, and there's different sections. We call them movements. Do not clap. Be on your best behavior. Sit with your hands folded on your lap. And in

• 15:47Speaker 01

  the 1700s, early 1800s, music was not that way. And it's really taken this shift. And again, I don't want to say elitist mentality, but it is on what is expected and how to perform and be on your best behavior in a classical music concert, which is not how classical music started as a performance. And I think that really does a disservice to reaching new audiences and to exposing people to music. I don't think we need to have a whole bunch of classical music lovers, but appreciators and understanding, because that is music that will help reduce our blood pressure, our stress levels. It's great for creativity, for activating our default mode network, and for so many different things.

• 16:31Speaker 01

  But classical music is not as accessible as we have the potential to make it as a society.

• 16:37Mike Carruthers?

  Yeah, there's something else about classical music I want to ask you about in just a moment. Sarah Sherman is my guest. She is author of the book Resonant Minds: The Transformative Power of Music, One Note at a Time.

• 16:51Mike Carruthers?

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• 19:56Mike Carruthers?

  So Sarah, what's interesting to me about classical music is I don't seek it out, but when I hear it, I really like it. I mean, and it does signal something. Like if you hear classical music in a hotel lobby, it classes up the place.

• 20:14Speaker 01

  I like that you chose the word classes up the place. So it already has to you also this level of sophistication associated with it, correct?

• 20:21Mike Carruthers?

  Yeah, just like in a restaurant with white tablecloths and classical music playing, you're gonna, you know, it's gonna be expensive. This is gonna be an expensive restaurant because it's a classy place.

• 20:34Speaker 01

  And so I don't disagree, but I think again, then it puts this barrier. I like to think of the the fourth wall and in classical music in particular, breaking that fourth wall of what our expectations are at a concert or performance. I run a classical music concert series called Mozart for Munchkins, and it's an interactive experience. So we'll do that. We'll play the Flight of the Bumblebee, but we'll encourage the kids to buzz around like bumblebees. Or we'll play Bach, and we encourage this element of breathing with Bach to it. And it's amazing what a one-year-old and a two-year-old can do when we give them the space to be themselves and to experience this serious music. They don't have to get it, but they can feel it. And the more exposed they are to them, it becomes taken down from

• 21:17Speaker 01

  this pedestal, almost as we often think about it. Like you said, this fancy restaurant or hotel or whatever it might be, and it can become more integral into accepting music, like the Death Leopard, whether you like it or not. But it also then breaks this barriers of our expectations of it. And it's not put in a box, here's classical music over here for when I do these fancy things.

• 21:39Mike Carruthers?

  Well, you know, I've never really thought about this before, but there is an expectation. Like if you go Into a fancy restaurant and there's music playing. It's likely something classical-y, or if not classic, real classical music. And if you, because what I'm thinking about is there's a grocery store not far from here that I go to now and again. And they don't play the music you would expect to hear, which is why I noticed it. Like, I can't tell you what the other grocery stores play, and they're all playing music. I don't even notice it. But this place plays oldies from the 60s. And I love it. And I notice it. But there is this expectation that certain places play certain mu-- you will hear certain

• 22:24Mike Carruthers?

  music in certain places and you will not hear certain music in other certain places.

• 22:29Speaker 01

  Music in elevators, restaurants, department stores, grocery stores is again a business that was founded in 1932 called Muzak. So when we think of elevator Muzak, it's actually the name of the LLC, Muzak Holdings LLC. That started this idea when you go into a store, and the idea was when you play a certain type of music, it might make people buy more things if you have this type of music that will encourage them to pick up more items on their way out. It's the, think of it like the little kids at, and all the candy or all the chips that are right near the cash register and you see parents scrambling, "No, no, no." But very rarely do you have classical music, which again is this calming music, or it

• 23:11Speaker 01

  doesn't have to be classical, but instrumental music with a low amount of beats per minute that kind of keep us in this calm, grounded state. I love the oldies and I love that they do that. And so somebody, somewhere is intentionally picking that soundtrack for that grocery store.

• 23:29Mike Carruthers?

  I'm always interested in how people get to like the music they like. And I imagine it has a lot to do with just the music you're exposed to in your home growing up or whatever. But I remember, because I come from the radio, the music radio business, worked in music radio for a long time. And remember, program directors at radio stations talking about this, about how they would play a song, they would choose whatever song, new song that they're going to play. If you play a song over and over and over again...

• 24:06Mike Carruthers?

  People get to like it. It becomes a hit. That's how hit records become hit records is if it's played enough, people become familiar with it and that familiarity turns into liking.

• 24:20Speaker 01

  I love that that story and because it's when I talked about cues before, it's the idea of something becoming, listening to it consciously and having all of a sudden go into our subconscious. And so then, oh, actually, I like this song. If you've heard it enough times, you know this song, whether you realize how you've learned it to begin with. And so it's the same if we think about buttoning our shirts or brushing our teeth or learning how to tie a shoe. It's this action that we purposefully focus on. It's something our explicit memory. We are trying to remember how to do this action and eventually it goes into our subconscious, our implicit memory, and we do it automatically. And music is exactly the same. Think about songs from

• 25:02Speaker 01

  your childhood or when you hear a song and you can have a very vivid memory of what that's attached to. And it's because of the way you've listened to it however many times. Or if I sing this to you, duh, um, but um, after two notes, what is that song?

• 25:18Mike Carruthers?

  Jaws.

• 25:19Speaker 01

  But yeah, two notes and you know exactly what song it is, but you didn't sit there and think, hmm, here's two notes, here's Jaws. It's because it has been ingrained from watching the movie. That song itself has become so used in pop culture that we have this association with it. So that absolutely makes sense that Radio Show Host did this and that people were all of a sudden having favorite songs because it was prescribed for them on repeat. And they were then having these associations, maybe whatever they were doing it and creating these positive memories while they were listening to it, whether it was intentional or not.

• 25:54Mike Carruthers?

  Maybe you can explain this phenomenon to me. And I bet it's something that's happened to everyone listening to us talk right now. If you were to say to me, okay, here is a song, and you name the song, and it's a song I know, I've known it all my life. What are the lyrics? I couldn't tell you. I probably don't know the lyrics. I might know a few of them, but I don't know the lyrics. But if you play the song, I'll be able to sing along with it and not miss a word. So I did know the lyrics. But I couldn't tell you what they were unless I had the song playing with me. What's that?

• 26:32Speaker 01

  Music predates language. Neanderthals used music as a way of communicating. Some of our earliest instruments are vulture bones created and carved into a flute. And again, predating language is a form of early communication. So when we think about using music as this tool to connect with one another before language, whether it's rhythm, whether it's creating sounds to tie emotions, music and emotions are so linked together when we hear certain sounds. Like I mentioned, it ignites different parts of our amygdala, whether it's happy or sad, and sounds have that capability.

• 27:13Speaker 01

  So the more that you are singing a song and attaching it to a melody and to the harmony underneath it, especially if you've sang it with other people, absolutely, it's easier to remember than if I ask you even happy birthday. I'm sure if you had to write down the lyrics to happy birthday, you have to think about it or sing it in your head in order to write it down. It doesn't just seem thing happy birthday. Our brains don't function that way. Everything is intertwined and integrated together when it comes to the music.

• 27:42Mike Carruthers?

  One question that I've always wondered about, and I think every parent and every student has wondered about, is is it a good idea when you're studying to listen to music? Or is silence better?

• 27:57Speaker 01

  A good question, and I think it's very individualized. Again, music as that cue can absolutely help if you're having a hard time focusing. But again, if you're listening to music with lyrics when you're trying to write or focus, it detracts from that because music never really is a background noise like we talked about. So it's finding that music that supports that. If you find that silence really works for you, wonderful. But I think it's worth experimenting with different types of music and with silence to see what works for you with different types of sounds throughout the day.

• 28:32Mike Carruthers?

  Well, it's really eye-opening to realize how much music we're exposed to, much of it just in the background. But as you point out, there's no such thing as just in the background. It all affects us in different ways. And I appreciate you explaining this. Sarah Leila Sherman has been my guest, and the name of her book is Resonant Minds: The Transformative Power of Music One Note at a Time. There's a link to her book at Amazon in the show notes. And Sarah, I thank you for coming by.

• 29:02Speaker 01

  All right, thank you, Mike. Thanks for really interesting questions.

• 29:05Mike Carruthers?

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• 31:15Mike Carruthers?

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• 31:56Mike Carruthers?

  Just go to indeed.com/podcast right now and support our show by saying you heard about Indeed on this podcast. Indeed.com/podcast. Terms and conditions apply. Need the right hire fast? Then this is a job for Indeed Sponsored Jobs. I imagine, like me, that if your doctor prescribes you a medication, you don't question it very much. You figure the doctor knows what he or she is doing. They wouldn't prescribe something if they didn't think it would work, or if it wasn't safe. And you may or may not worry about the cost, depending on whether or not you have insurance.

• 32:39Mike Carruthers?

  And in any case, you figure it's probably necessary, it's most likely the best thing out there to treat whatever is wrong with you, and so you go with it. If that is pretty much the way you operate, it's pretty much the way I operate, then my guest you're about to meet would say, "You're making a lot of assumptions that you shouldn't be making, and potentially putting your health at risk." And it just might be worth hearing what he has to say. Jerry Avorn is a medical doctor and professor of medicine at Harvard Medical School. He has built a leading research center at Harvard to study medication use, outcomes, costs, and policies. He has written or co-written over 600 papers in medical literature,

• 33:24Mike Carruthers?

  as well as opinion pieces in The New York Times and The Washington Post. He's author of a book called Rethinking Medications: Truth, Power, and the Drugs You Take. Doctor, welcome to Something You Should Know.

• 33:38Speaker 02

  Thank you for having me.

• 33:39Mike Carruthers?

  So first, explain your overall view on medications and what you think people might want to consider when the doctor prescribes them something to take.

• 33:49Speaker 02

  Sure. I think anybody that takes a medication has a number of questions that either they wonder about or they ought to wonder about. One is, does it work and how do we know if it works? The second is, is it safe and how do we know that? What side effects might it cause? The third is, why does it cost what it costs? And can I get it for less money? And then there's a whole host of related questions about what are we doing as a nation to try to make sure that we get it right on those issues of, does it work? Is it safe? And is this the right price for it?

• 34:25Mike Carruthers?

  And we should be concerned about this why. And here's why I ask. I would assume my doctor is not giving me a pill that doesn't work. He must know why it works. He must think this is a good thing. My insurance is going to pay for it. So why do I need to listen and worry about any of the things you just mentioned?

• 34:46Speaker 02

  Great question, Mike, and in fact, we do need to wonder about all of those things for a couple of reasons. One is, we doctors do the very best we can, but we can only work with the information that is out there and available to us. And for that, we rely on the FDA to tell us whether a drug is effective and safe. Many people, including a lot of doctors, think that the FDA tests drugs. It doesn't. It doesn't test any drugs to see if they are effective. It relies on studies that are submitted to it, usually from the manufacturer. And one of the more surprising issues is that often the manufacturer will set up

• 35:25Speaker 02

  those studies in a way that will put the drug in the most favorable light, even if it actually turns out not to help people. And, you know, we can't blame the physician on the front lines for that, because all we can do is rely on the decisions made by the FDA. Over the years, FDA has gotten way too loosey-goosey about accepting data that are presented to it by a manufacturer, even when that data does not demonstrate, as it really ought to legally, that the drug is indeed safe and effective.

• 35:58Mike Carruthers?

  But even if the FDA doesn't do that, I would think my doctor has experience with his own or her own patients that would indicate, yeah, this seems to work in a lot of cases, so let's give this a try, and, you know, my other patients aren't dead, so yeah, let's go.

• 36:16Speaker 02

  Right, and that is exactly not a good way for a doctor or for a patient to determine if a drug works, because the experience of any one doctor is not going to be enough to reveal whether a particular drug is effective, and is certainly not going to be able to reveal whether that drug works better than another drug that I might have prescribed for that patient. Really, the only way we can know that is by well-designed, well-conducted studies of hundreds or thousands of patients, where all those issues are looked at carefully.

• 36:48Mike Carruthers?

  I know there have been individual cases of drugs that have been approved for use, put on the market, and then pulled because something was wrong, and that does happen. But generally speaking, and my assumption is that, when, once drugs are approved, they've been tested rigorously enough that if they're approved, they're probably okay.

• 37:11Speaker 02

  I think probably okay is a good term to think of because I think what Americans deserve is not probably okay. I think we deserve to know that even though every patient is different and you can never tell 100% of the time how something's going to work, we do rely a little bit more on probably okay than we ought to. So for example, the drug that was in the headlines a number of years ago for Alzheimer's called Aduhelm. And it's part of this larger problem that going back to the AIDS epidemic in the 1980s, the FDA was trying to get drugs out there approved as quick as possible for obvious reasons. People were dying every single day and there's nothing good to treat them. So

• 37:55Speaker 02

  they created this thing called the accelerated approval pathway, which made a lot of sense at the time. And it said, even if the company has a drug that may or may not work, if it looks like it maybe makes a lab test look better, let's approve it, get it out there, and then make the company do a study afterwards to see if it really works. And that way you won't have AIDS patients or cancer patients feeling like there was a drug that could have helped me, but the FDA took so long to study it that, you know, I died, or my friend, or my mother, or father died before the drug was made available. So that made sense back in the 80s and the 90s. The problem is that has grown into a loophole big enough to

• 38:36Speaker 02

  drive a Brink's truck through. And what I mean by that is that the FDA has gotten way too comfortable with the idea of saying, well, nobody really showed this drug helps patients, but it makes a lab test look better, so let's just let everyone have it. And then we'll ask the company to do better studies later. And that's where that Alzheimer's drug, Aduhelm, came from. The FDA said, no evidence that this clearly helps patients with Alzheimer's disease to have any better memory, but it makes your brain amyloid levels seem a little lower, so let's approve it. And then they did not get around to making the company do follow-up studies.

• 39:16Speaker 02

  And as a result, we have this drug that the initial list price was $56,000 a year. It can cause brain swelling and hemorrhage and stroke. And so, you know, no drug is going to be without side effects, but you're willing to accept them if somebody has shown that the drug really works. But if nobody's shown the drug works, and we know it causes side effects like brain swelling and bleeding, and it costs $56,000 a patient, that was probably one of the clearest examples of how we should not have approved that drug. And sure enough, later on, the drug needed to be pulled because after many years, it became clear that it was not only not helpful, but it was dangerous. So, you know, we need, given that we've got such wonderful drugs out there, we just need

• 40:00Speaker 02

  to do what FDA was assigned to do and has drifted away from over the years.

• 40:05Mike Carruthers?

  But from the patient's point of view, because I don't know if my doctor is going to prescribe a drug that's relatively new, it's been around for 50 years, should I be worried? And you can find plenty of examples, like the one you just gave, of pretty much disaster stories, and there are plenty of other examples, as you said, of great drugs that do wonders. So I don't, as a patient, know where should my worry be placed? I've heard, interviewed a doctor here that said, you know, they don't take a drug that hasn't been around and approved for a long time, just to avoid the kinds of things you're talking about.

• 40:42Speaker 02

  Right, and that, we shouldn't have to rely on, well, the drug's been around for many, many years before I'll take it, because frankly, the American public deserves to get access to drugs and not just, you know, make sure that it's been a decade and no one died from it, so I'll take it. I think the answer, and there are some very hopeful answers to these questions, it's not like we all need to. Throw up our hands and say, you know, I'm scared of drugs. Drugs are great. I love drugs. They are some of the best and most useful things we can do for our patients. I think we just need to hold the FDA to the standard that it was really expected to meet back in 1962 when its legislation was established

• 41:22Speaker 02

  that it needs to make sure the manufacturer showed the drug is safe and effective before approving it. And one of the maybe scarier points is that because FDA has gotten lax on that and has accepted changes in lab tests. And then as a marker for approving a drug, even though it doesn't show that it helps patients. And I think even worse, FDA has then failed to follow up on requiring that the companies do the follow-up studies that the law requires them to. Which of course, the companies are happy to forget doing if they have a drug that may not pass those tests and they can leave it on the market, charge full freight for it.

• 42:04Speaker 02

  And then it may be years before we find out that it really doesn't help people. So I think all we need to really expect is that the FDA will do its job better than it has been doing. And the companies essentially have their feet held to the fire and be told, "Look, you can charge a lot for this drug, and if it's a great drug, that's okay and we'll pay for it." But you can't not study it adequately and then not do the follow-up studies that the law requires you to do and expect that somebody is going to come up with either $50,000 or in some cases $300,000 a year as we see in the drugs for muscular dystrophy, for drugs that have not been shown to help.

• 42:43Mike Carruthers?

  As a doctor, maybe not you because you're so into this, but generally speaking, a doctor begins prescribing a new drug. He's got to feel pretty comfortable or else he's gotten a good sales pitch. What does it take for you or other doctors to say, "Here's this new drug, this drug company's been asking me to prescribe it and so I'm going to start prescribing it because now I know what."

• 43:11Speaker 02

  So I think one of the things that I, when I teach doctors, I urge my colleagues to do is just because it's new and shiny and there's a tremendous sales pitch that you're presented, you know, maybe over a delicious dinner at the best restaurants in town. I think all of us as doctors ought to have a, just a high level of wanting to see more about the evidence. And that doesn't mean that every doctor needs to study every drug, but to not assume that if it's new and it's expensive and it's FDA approved, it's gotta be better than what we've already got. Sometimes it is, and we need to be very open to that, but sometimes it isn't. And, you know, you can just turn on the TV and see all the different psoriasis and eczema drugs that are so lavishly advertised.

• 43:55Speaker 02

  And frankly, a lot of them are not a lot better than the older ones that we have that are way cheaper. So I think doctors and patients alike need to basically have a high level of scrutiny about how do we know it's better? And doctors can ask that of the sales reps that come to visit them from the companies. And I think patients can also ask their doctors. First of all, you should ask, what is this gonna cost me? Because we've got an awful lot of prescribing that we as doctors do, we have no way of knowing what it's gonna cost the patient. And I've often had patients, I write them a script, it looks like a good drug for them, and then they go to the drugstore and they find out what it's gonna cost, even if they have health insurance and they can't afford it.

• 44:37Speaker 02

  So I think there is a responsibility of us doctors to learn more about what things cost. And for patients, when you're with the doctor, I think it's perfectly fair to say, is there a related drug that is gonna be more affordable and work just as well? And any doctor worth his or her salt ought to be willing to answer that question.

• 44:57Mike Carruthers?

  When you get pitched by a drug company, a guy comes, a rep comes in and tells you, do you, do they not volunteer and do you typically not ask, what's this gonna cost my patient?

• 45:10Speaker 02

  They do not volunteer it because that's not a selling point. They are trained heavily on what are the selling points? And affordability is usually not a selling point. And I will, I don't see sales reps anymore because it is not a useful way to learn about drugs. But when I used to, and if I would ask that question, they would say, Dr. Avorn, I'm just here to tell you about the new product. I don't get into pricing. But what you can do is there's a couple of apps that are out there that people can look up and find out what is this drug going to cost? Doctors can look it up, patients can look it up. And to see if there's maybe another drug that works as well and is going to end up

• 45:51Speaker 02

  being much more affordable because one in five Americans cannot afford the drugs that we doctors prescribe for them. So something is wrong. If we make a careful prescribing decision, the patient gets to the drugstore and then they can't buy what we prescribe because it's too expensive.

• 46:07Mike Carruthers?

  Well, you said something about how a lot of the drugs that you see on TV for eczema and whatnot aren't any better or probably very little better than what we've already got. Is that, is that a fair assessment of what you said?

• 46:21Speaker 02

  Absolutely.

• 46:23Mike Carruthers?

  So why do they come up with these new drugs? Is it just kind of like introducing the new model car? We just need something a little more fancy and expensive and to kind of churn interest up again?

• 46:34Speaker 02

  Yeah, I think that is exactly it. I think you said it perfectly, that if we have a system in which any drug can show, all it really has to show is that it's better than placebo or better than nothing. That is the legal standard that unless it's a condition where you've got a treatment, you know, like HIV or cancer where you have a drug you know works, you can't test your new drug against just a sugar pill. But for a condition like eczema, which is not going to kill anybody or psoriasis, it is okay, I mean, is allowed by the law to test the drug against nothing. And the legal standard is that if you can show, if you're a drug company, you can show your new drug works better than placebo,

• 47:17Speaker 02

  the FDA is kind of legally obliged to approve it. And that is problem one. Problem two is that the company then gets to decide what it wants to charge for it, and it can charge whatever in the world it wants to charge.

• 47:32Mike Carruthers?

  So clearly, you're not a big fan of the way the drug approval process works. But the process that's in place had to have been approved by somebody or some people. If I were to call them and say, "Defend it. Defend the way things are done now," what would they say?

• 47:50Speaker 02

  They would say, "We are under a ton of political pressure to not make enemies in high places." And this is the case for both the Democrats and the Republicans. This is an equal opportunity problem we've got. Most people don't know that about half of the salary that FDA pays to the doctors and other scientists who review the drugs that it's evaluating are actually paid by the drug industry. And that has a long history where the Congress had not given FDA enough money, and that was before the current cutbacks, hasn't given FDA enough money to hire enough people to review the drugs. And back in 1992, the drug industry came along and said, "Well, that's a problem for

• 48:35Speaker 02

  us too, because we want our drugs approved quickly. Why don't you let us pay something that's known as user fees? And we will simply pay the FDA a huge amount of money for each drug that it reviews, and that's how you can meet salary for your scientists to review the drugs." You know, for me, that makes about as much sense as saying, "Well, you know, the court system is kind of strained, so why don't we let all the plaintiff's attorneys or the defendant's attorneys pay the judges, because that way we'll have enough judges." I think, you know, if the judge is getting paid by one side in the courtroom, we all know where that can lead. But unfortunately, that's the system we've sort of backed into with these user fees that now comprise, as I said, about 50% of FDA salaries in its drug approval branch.

• 49:19Speaker 02

  So one thing I would say to the hypothetical person at the FDA is, "We need to figure out a way that you can actually get enough money from Congress that you can pay your own staff and not rely on user fees from the drug makers that you're supposed to regulate to be able to meet payroll."

• 49:36Mike Carruthers?

  But your analogy of the court system is different in that theoretically approving drugs is not an adversarial situation where you have defendants and plaintiffs. It's we're all in this together to see if this drug works.

• 49:51Speaker 02

  Actually, Mike, I see it, I don't see it that way at all. I do think of it, although it shouldn't be, you know, sort of nasty with people, you know, kind of pounding the table. But I think in a very kind of quiet and careful way, a lot of science is sort of adversarial in the sense that you're describing it. And that is, I think the assumption needs to be that when a new drug comes to the FDA, there's no assumption that it works, there's no assumption that it doesn't work. I think one needs to just say, I don't know if this is a good drug, I don't know if it's a bad drug, I just want to look at all the evidence and let the people who are bringing it forward give me their best shot.

• 50:32Speaker 02

  And I, as an FDA reviewer, for example, if I worked at the FDA, I'm going to basically say, that may or may not be true, I want you to convince me. I think that's a very healthy, scientific, gentle way to proceed without any assumptions being made one way or the other. And that's probably the best way to do science.

• 50:50Mike Carruthers?

  But so what's the way now?

• 50:52Speaker 02

  The way now is that the industry has gotten an enormous amount of influence about these decisions, and the FDA is under a lot of pressure to basically, you know, please the industry, because that is the side their bread is buttered on. And the industry is always complaining that, oh, FDA is keeping these great drugs away from the American people because they're so sluggish and obstinate. In fact, when we and others have looked at the data, the FDA is about as fast an approval agency as any in the world. Traditionally, the FDA has been able to turn around a decision within six months of getting, you know, terabytes of data that it reviews very carefully, and I don't think you'd want them to do it too much faster.

• 51:38Mike Carruthers?

  So put this in some perspective because you've been talking about some instances and some procedures and some things that are in place that might tend to make someone think, well, you can't trust drug companies. So what's a consumer to think?

• 51:53Speaker 02

  Again, I certainly don't want to leave listeners with the sense that most drugs on the market are unsafe or don't work. You know, most drugs on the market are safe and do work. And I guess I just would love it if we could be more scientific about getting it right nearly all the time instead of most of the time.

• 52:11Mike Carruthers?

  Well, so much of what you've said I've never heard before. And maybe I have tried to ignore it too, because I want to believe that if drugs are available, they've got to be safe, they've got to be effective. If a doctor's prescribing it, he must or she must know what they're talking about. There's all this gray area, but I appreciate you explaining it. Jerry Avorn has been my guest. He is a medical doctor and professor of medicine at Harvard Medical School. And the name of his book is Rethinking Medications: Truth, Power, and the Drugs You Take. And there's a link to that book at Amazon in the show notes. Jerry, thanks for coming on and sharing your expertise about this.

• 52:50Speaker 02

  Thanks, Mike. I've really enjoyed talking with you and thanks for having me.

• 52:54Mike Carruthers?

  If you remember the good old days, you probably don't remember them very accurately. It seems that people who long for the good old days have a very idealized memory. According to some research at Carnegie Mellon University's Tepper School of Business, people have a tendency to block out their negative past experiences while we fondly remember the good times. The research shows that we cherry pick our memories and leave out the unpleasant ones. While we look at the past through rose colored glasses and remember the best moments, we look at the present for both the good and the bad. So naturally, the present never

• 53:38Mike Carruthers?

  seems as good or as enjoyable as the good old days. And that is something you should know. If you haven't left us a rating or review recently, or ever, this would be a good time. A rating, well, that takes no time at all. You just, you know, pick how many stars, preferably five stars would be good. A review is even better. It just takes a few minutes to write something, write a comment about this podcast. We read them all. We appreciate getting them, and it also lets other people know what other people think about this podcast. I'm Mike Carruthers. Thanks for listening today to Something You Should Know.

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