The History and Future of Medicine with What the Health Just Happened

Eric Ross 0:00

Ladies and gentlemen, welcome to this week's episode of What the Health Just Happened, where we talk about all things healthcare, community, wellness, and life, the goods, the bads, the ups, the downs, the left's, the rights, and everything in between. We are so fortunate to have on a variety of guests way smarter than we are, especially today. This guy, you came on a couple years ago, but my goodness, he's way smarter than we are, Trey. Oh, absolutely. We're gonna do our best to keep up with him. Your credentials are so long. I don't even know what to read. Dr. Michael Koren, founder, CEO, and medical director for Jacksonville Center for Clinical Research and the host of the nationally recognized recognized. I'm butchering this, I love it. MedEvidence podcast and radio show. I want to start right off the bat. There's so many things. Cardiologist went to Harvard, well connected. Medical research obviously is your specialty, but Med Evidence right off the bat. I think the show that you do, way better than ours. We've got some humor tied to it. We butcher the intro. That's my favorite thing. But your show, is it the truth behind the science, the truth behind the data? The truth behind the data. So what does that mean?

Dr. Michael Koren 0:59

So you can present you can present facts to people and you can lead them down the wrong direction or the right direction based on how you put the facts together. So there's an underlying truth behind the facts or the data. And we help people understand that. Because otherwise, and this happens in media, unfortunately, you get a bunch of facts that will lead people down to one pathway versus another without presenting corresponding information that helps you really get to the truth.

Eric Ross 1:31

What about social media? There's no facts. People just talk in front of camera. I mean, that's the world we're in.

Dr. Michael Koren 1:36

Yep, yep. So you ever heard hear the word solipisic?

Eric Ross 1:43

That's a big word. No, say it again.

Dr. Michael Koren 1:45

I pronounced it wrong. Solipsism.

Eric Ross 1:47

Solipsism.

Dr. Michael Koren 1:49

Solipsism. Right.

Eric Ross 1:50

Solipsism. Definitely not.

Dr. Michael Koren 1:52

Okay.

Eric Ross 1:52

Caveman.

Dr. Michael Koren 1:53

Okay. Solipsism is a

Solipsism And Why Facts Mislead

Dr. Michael Koren 1:55

philosophical concept that whatever you're feeling at any given moment is the truth.

Eric Ross 2:00

Oh, that could be dangerous. Say that again.

Dr. Michael Koren 2:03

Solipsism is the philosophical concept that anything that you're feeling at any given time is the truth.

Eric Ross 2:13

That's dangerous.

Dr. Michael Koren 2:14

Exactly.

Eric Ross 2:15

That's dangerous.

Dr. Michael Koren 2:16

And there's a whole school of philosophy around that. And our society has become very solipsistic. Meaning that people get emotional about something, they have a point of view about something, and they forget that that may not be the truth. What you're feeling at that time may in fact not be the truth.

Eric Ross 2:36

Let's give some background here. That was a very butchered intro. I love when we butcher the intros, right? You've been a-

Dr. Michael Koren 2:42

I butchered solipsism. So we're guessing

Eric Ross 2:45

That's a big word, right? I'm just reading off a piece of paper. You have a long history in in the healthcare industry. Yes. What what's your background? I know it, but

Dr. Michael Koren 2:54

Sure. Sure.

From Ether Parties To Evidence

Dr. Michael Koren 2:55

So I'm a cardiologist.

Eric Ross 2:56

Smart.

Dr. Michael Koren 2:57

Yep. I went to Harvard Medical School and

Eric Ross 3:00

-never heard of it.

Dr. Michael Koren 3:00

Yeah. Studied at MIT while I was there. And then I did my residency and cardiology fellowship at Cornell, New York Hospital in Sloan Kettering. And then moved to Florida in 1991 to do a hybrid research medical practice where we brought the concepts of clinical research to a community-based setting. And I've been doing that since 1991. We launched Jacksonville Center for Clinical Research in 1997 in order to get more community-based doctors involved in research, even outside of cardiology. And here we are today with the Encore Research Group and my current partner, which is called Flourish Research, which is a national group trying to develop these concepts around the country.

Eric Ross 3:45

Harvard MIT, Cornell cardiologist, knows what he's talking about. He's built for this. Yeah. You're designed for this. So medical research, for those that don't understand, how vital is that to healthcare? How important is medical research?

Dr. Michael Koren 3:59

Oh, it's a backbone of medical care. So we have something called evidence-based medicine. That's why we call our podcast platform and our overall media platform MedEvidence, because something changed fundamentally probably about 50 years ago in medicine, which is that instead of just making decisions based on experience, we started making decisions based on structured studies and structured investigation. So if you go back to the way medicine was practiced 200 years ago, for example, the way anesthesia became practiced. So I don't know if you know that story, but it's a fascinating story. The concept of ether anesthesia was actually a party game that seriously, this is how how British chemists got high back in the 1780s and 90s.

Eric Ross 4:50

Sounds like a good party, but-

Dr. Michael Koren 4:51

and basically they mixed sulfuric acid with alcohol. And then the fumes that came up were ether

Eric Ross 5:00

not healthy.

Dr. Michael Koren 5:00

Well, it they would they would they would have ether parties where they would suck in these fumes and then get get giddy and high and and stagger around and then you know move on. So literally, this is how it started.

Eric Ross 5:12

Hey, man, someone had to do it.

Dr. Michael Koren 5:14

This is how it started. So then it moved forward, and people in America started discovering this concept of ether, and they said, well, let's see if we can medicalize it and let's see if we can make a profit from it. Okay, so that's the American way is to be entrepreneurial about it rather than just a fun party game. So a couple of people got very involved in this. Uh, one of them is a name that you might have heard of called Crawford Long, who the Emory Hospital is named after. And he was a local surgeon in the Georgia area. And instead of just cutting somebody's leg off and giving them some alcohol before as a pre-med, he said, huh, let me try this ether thing.

Eric Ross 5:50

What year was this?

Dr. Michael Koren 5:51

This was probably in the 1830s 40s, 1840s.

Eric Ross 5:55

This is the beginning of medical research?

Dr. Michael Koren 5:56

Yeah, this is I'm I'm giving the example of how we used to learn compared to how we learn now. Okay. And then there was a Dr. Morton who was actually a dentist in Massachusetts, who actually is given credit for the development of anesthesia because he presented his data at Mass General Hospital in a very famous lecture hall that I attend lectures in called the Etherdome. And he showed for the first time how ether could be used to anesthetize somebody that was having surgery from a very famous surgeon at the time named Dr. Warren. And Dr. Morton, who is the dentist, was hoping that this would be his route to fame and fortune. He tried to patent this and he spent his whole career trying to monetize anesthesia, mostly unsuccessfully. But anyhow, the point of this story really is that we did this based on storytelling. There was a British scientist, and people started parting with this, and they realized, you know, people kind of pass out with this stuff, but they still breathe, so let's try it for surgery.

Eric Ross 6:55

Don't get high on your own supply, right? Right.

Dr. Michael Koren 6:58

There was there was no real informed consent. There was no structured experimentation.

Eric Ross 7:02

It was just here, smell this, we're gonna cut your leg off.

Dr. Michael Koren 7:05

This worked out pretty well. Right, pretty pretty well, yeah, basically. Okay. 1800s. Well, 1840s, yep. And anyhow, so from there we got to the modern era, but it took a long time. It took about 150 years, where everything we do in medicine is based on a structured experiment. So, whatever the innovation is, we develop it under these ground rules and these protocols that allow us to start with early phase research, where they're first in human studies, and there's certain safeguards put in to make sure those are as safe as they possibly can be. And then if we get a proper signal, then we go to the phase two studies. And if we get a proper signal, then we go to the phase three studies where we broadly test these products in thousands or even tens of thousands of people before we ultimately come to a solution about whether or not something should be on the market. So there's been an incredible evolution. And that's a very quick story.

Eric Ross 7:58

That's a great, great summarization, by the way.

Dr. Michael Koren 8:00

Well, thank you.

Eric Ross 8:01

And great story about the ether part. Gotta research that. So 1997, that's when you got to Jacksonville, that's ENCORE is the current medical research organization. What was the other one you mentioned?

Dr. Michael Koren 8:12

Yeah, Encore is an acronym for Encouraging Community Research and Education.

Eric Ross 8:15

And then you mentioned another one.

Dr. Michael Koren 8:17

There was MedEvidence, and then there was Flourish. Flourish is the one, which is the national company that the Chief Scientific Officer of

Drug Patents And Trial Timelines

Dr. Michael Koren 8:25

that is now taking what we've done here locally and combining with other sites and creating a national presence.

Eric Ross 8:31

I like the process of doing the research, getting it to market. I want to say Viagra is the greatest example. We talked about that last time. Maybe it's GLP1s, insulin, anything. Phase one to get through that, what's the time frame? Then phase two, when do you get it to market where these people spending millions of dollars can get that money returned?

Dr. Michael Koren 8:51

Once a company applies for a patent, they're granted 20 years of exclusivity. But it can take up

Eric Ross 8:58

Oh, please be them. Oh, yes. Unfortunately. Oh, we're waiting. Hey, normally we have phones on silence. This one is not because he's waiting on a call from FIFA and Stub Hub.

Dr. Michael Koren 9:07

Right. It's just the love of my life that I'll have to put on hold for now.

Eric Ross 9:10

You can answer it or boss edit her call.

Dr. Michael Koren 9:12

Hold on here. Hello?

Eric Ross 9:15

Oh, this is gold. Okay. We love answering calls on the on the show. I hope they call. We got a story about that. Absolutely. In Any event.

Dr. Michael Koren 9:24

We were talking about phase one in the early phases. So 20 years of exclusivity, that's when you first discover the molecule or device, whatever it may be. And then you have to do all the pre-human testing, make sure it's safe in animals, et cetera. And that can take anywhere between five and eight years. And then typically the early phase testing is going to be another two or three years to make sure that it's safe in humans and to really understand the signal and what you can expect in later stage research. And then phase two through four can ultimately take another five years. So you can see if you have a 20-year patent life, it could easily take 10, 12, even 14 years to get something to market.

Eric Ross 10:04

I think this matters for people that are anti-pharmaceutical companies, healthcare in general, which I can make an argument for both. But if you're spending millions of dollars, what's the average cost to get a drug to market?

Dr. Michael Koren 10:16

There's different ways of looking at that, but a big drug is in the billions now. It can easily be a couple of billion dollars.

Eric Ross 10:25

For easy, $500 million to get this medication to market. You're just bleeding cash.

Dr. Michael Koren 10:30

Yes.

Eric Ross 10:30

It could take up, you have a 20-year patent. It could take 15 years to get to market.

Dr. Michael Koren 10:34

It can. Now, if you're really efficient, it could be less than that, of course. So it can be done as quickly as five to seven years, but it's usually somewhere between that five and fifteen year mark.

Eric Ross 10:43

What do you think makes it less complex? Is it the medication itself how it's made?

Dr. Michael Koren 10:49

There's a lot of factors, a lot of factors involved. Obviously, some of them have to do with the the interaction with the Food and Drug Administration. So the FDA is very involved in all these things. They are signing off on all these protocols. And if they deem

Project Warp Speed And The Fallout

Dr. Michael Koren 11:05

that there needs to be a push to get things in the market more quickly, it'll happen. We saw that with the COVID-19 vaccines, right? Yep. So that that was unprecedented. We went from nothing to an approved drug in a year because

Eric Ross 11:18

unheard of.

Dr. Michael Koren 11:19

Right. Completely unheard of. And because all the barriers were removed by the government. Project warp speed.

Eric Ross 11:24

We're gonna hit that in a second.

Dr. Michael Koren 11:25

Okay. During the AIDS crisis, there was an accelerated approval of drugs. So that that was done. But on the other hand, there have been other drugs that have gone through a very, very careful, slow process that can take 10, 12 years or more.

Eric Ross 11:41

Before we talk Project Warp Speed, what a fun term, by the way. It sounds like an 80s movie. What are some medications you think took too long to get to market?

Dr. Michael Koren 11:51

Ooh. That's a good question. Let me ponder on that just for a second.

Eric Ross 11:54

You don't have to answer an hour, didn't get to market then we should have.

Dr. Michael Koren 11:57

I will answer it. So I'll give an example. When we were working on the statin drugs, the first statin drug that got approved in the market was called Lovastatin in 1986, 87 timeframe. And that was approved uh based on about eight to nine hundred patients. Okay. And that was a good drug, but not the best drug. Then there were iterations of the drug. We went to a drug called Simvastatin, and then we went to a drug called a torvastatin or lipitor, and then a drug called Resuvastatin or Crestor. And Crestor was approved around 2002. But in order for Crestor to get approved, we had to do studies that involved 15 to 20,000 patients versus 800 for the first ones because of an increased FDA scrutiny. And drugs like Resuvastin have been shown to be more effective than drugs like lovastatin, where we started. So that was a slower process. There was an incremental benefit between the newer drug and the older drug, but to answer your question, it may have taken a longer time than it could have.

Eric Ross 13:03

Oh, healthcare and drugs. Remember that the DARE logo? D-A-R-E, like I forgot what the acronym was. I'm gonna make you a t-shirt. It's the DARE drugs are really expensive. That's one of my favorite t-shirts I made. They really are, just to get it to market. And then once you get it to market.

Dr. Michael Koren 13:21

So no doubt.

Eric Ross 13:22

Let's do it. Let's I don't know if this is political or not. I'm good either way. Project Warp Speed, that's what it's called. Yes. This is recent. You were talking about this before we turned the cameras on. Trailblazer. Project Trailblazers. Trailblazer. Project Trailblazer. Sure. I like Warp Speed, by the way. Project Trailblazer will take it.

Dr. Michael Koren 13:44

That's how the COVID-19 vaccines got on the market.

Eric Ross 13:46

Okay.

Dr. Michael Koren 13:47

So the remember the the first two to get on the market were the Moderna drug and the Pfizer drug that got approved within one week of each other. And just remind you, the Moderna drug was largely funded by the federal government. The Pfizer drug was actually privately funded by Pfizer. But they all had the advantage of having all these typical barriers taken away.

Eric Ross 14:07

Were you testing this here?

Dr. Michael Koren 14:08

Oh yeah? Yeah, I was actually a co-author in the Pfizer publication for one of the COVID-19 vaccines.

Eric Ross 14:15

It feels like 30 years ago.

Dr. Michael Koren 14:17

That was only a couple years ago. Yeah, amazing. Yeah. Doesn't it seem like so long ago? Yeah. So that was Project Warp Speed. That was it was uh probably, in my humble opinion, not to get political, but probably the most important accomplishment of the first Trump administration.

Eric Ross 14:31

In a good way or a bad way?

Dr. Michael Koren 14:34

Oh, Project Warp Speed was amazing. Getting it to the market. Right. Now, of course, there was a flip along the way just to get a little political.

Eric Ross 14:40

Let's do it.

Dr. Michael Koren 14:41

Okay. Yeah. Yeah, Dr. Fauci and others were very involved in getting the vaccines to market. And then Trump, of course, lost the election. Uh, some may argue because the vaccines weren't improved until after election day. Trump may think about that or other things. But then that administration and people within that administration sort of turned on Fauci and the other people that had developed the vaccines. And there's a lot of politics in this, but there was a flip. So I always found that interesting that in the 2021 era where there was all this debate about how we go back to normal, and people were on the right, we'll say were being extremely critical of Dr. Fauci and others. They forgot that this all started with Project Warp Speed, which was a Trump initiative.

Eric Ross 15:31

You got something to add to this?

Off Camera 15:32

No, I was just going to say do you think there will be a time and place in the future where a medication will need to skirt through the marketplace?

Operation Trailblazer And Reshoring Research

Off Camera 15:40

Oh yeah.

Dr. Michael Koren 15:40

Well it it'll it'll happen for sure.

Off Camera 15:42

Do you think it would ever be a good one?

Dr. Michael Koren 15:43

Well, this is the Project, let's talk about Trailblazer now. So-

Eric Ross 15:47

you just told me that I didn't know, and I'll research afterwards.

Dr. Michael Koren 15:48

Yeah, so again, that's warp speed. Now the most recent initiative, also from the Trump administration, is called Operation Trailblazer. And I just mentioned the fact that the early phase research for phase one involves first healthy volunteers and then people who are relatively stable with the disease, typically. And what's happened in recent years is that work has moved outside of the United States. So

Eric Ross 16:16

Where? China, Europe, China.

Dr. Michael Koren 16:19

Actually, probably the place where it gets done more than any other place on the planet is in New Zealand and Australia.

Eric Ross 16:26

Really?

Dr. Michael Koren 16:27

Because those countries have given companies tax incentives to do very early stage work in their countries. I'll tell you a funny story. I I actually was touring New Zealand about 10 years ago, and I was taking a cab in New Zealand, and the guy asked me what I did, and I said, Well, I'm a cardiologist that runs clinical trials. And I figured he had no idea what he's talking about. Oh, yeah, we know all about clinical trials here in New Zealand.

Eric Ross 16:50

That's the thing they do there.

Dr. Michael Koren 16:51

Yeah, because they they do it, they promote that.

Eric Ross 16:53

That and rugby, by the way.

Dr. Michael Koren 16:54

And they're good in rugby.

Eric Ross 16:55

And surfing.

Dr. Michael Koren 16:56

Yeah, yeah. Have you been to New Zealand?

Eric Ross 16:58

I have not, but it's on the top of my bucket list.

Dr. Michael Koren 17:00

Yeah, it's great. Yeah.

Eric Ross 17:02

Do you need a nurse for clinical trials? I'll fly out there and do some research either way. So you were you were there in the tab and mentioned this. So he's like, oh, yeah.

Dr. Michael Koren 17:09

I'm mentioning this because there's a very high awareness in that country of about four million people about running clinical trials, and they do a lot of early phase work there. And so nowadays, only a very small percentage of early phase work on patients is done in the United States. And the Trump administration has decided that for national security reasons and other things, they want to bring more of that work back to the U.S.

Eric Ross 17:34

How do you keep it here?

Dr. Michael Koren 17:36

Well, the U.S. has a couple leverage points. The biggest leverage point is that we're the biggest market in the world for medicines. So what the FDA is saying at this point, and what HHS has said, is that you do work here, we will accelerate your time frame to get approval in the United States. So, for example, if a company comes and does their early phase work here, and again, all the details are not laid out yet, but the concept is you do your early phase work here, and we'll make it one year shorter for you to get your drug approved. Well, one year of additional market exposure in the United States, protected by patents, is a very, very valuable asset.

Eric Ross 18:17

So what's an example, a cardiology medication you were doing in New Zealand, you bring that to the states the entire process, or do you still outsource some overseas?

Dr. Michael Koren 18:27

Well, again, it'll be a little bit of a dance, I'm sure, because the other advantage of Australia versus New Zealand for early phase research is that the cost is much less. So the per patient cost of developing a drug outside the U.S. is probably half of what it is in the U.S. Our costs are just higher. And so for that reason, there's going to be a bit of a trade-off, and I imagine there'll be some hybrid. But this operation in Trailblazer is really exciting and important because we're trying to pull back a critical industry that has left the United States, which is the early phase research. It's akin to what happened with computer chips, with microprocessors. Yeah.

Eric Ross 19:07

Right.

Dr. Michael Koren 19:07

So 40 years ago, all that work, all computer chips were made in the United States. And then subsequently they all moved overseas, where now Taiwan and Korea really manufacture the vast, vast majority of microprocessors, specifically sophisticated microprocessor important memory chips. Well, what has the government done? The U.S. government has now made it uh very clear that their incentives will bring that work back. And over the course of the last five or so years, there's all these projects that have been announced in the United States for foundries that are making computer chips. And people are spending half a trillion dollars investing. Yeah, this is like almost trillions, investing in foundries in Phoenix and Austin, Texas, and other places around the country to bring back the work that originally was in the United States, that went overseas, mostly to Asian countries, and now they're trying to bring it back for national security reasons, so that the supply chain for sophisticated electronics, including weapon systems, et cetera, et cetera, is here back in the United States. So with that concept in mind, they're doing the same thing for medicine. They want the basic science.

Eric Ross 20:17

Last serious question before we kind of start goofing off a little bit, then commercial break. Is this applicable to healthcare medications? The same thing. How do you bring this back to the states? Can we can we handle that in the United States, you think?

Dr. Michael Koren 20:28

Sure, absolutely. The infrastructure, all of it. Absolutely. Again, we we do have the expertise, we have the knowledge, but again, it moved overseas just like the computer industry, because the costs were less overseas and certain places created incentives for the manufacturers, either drug manufacturers or computer manufacturers, to do their work somewhere else.

Eric Ross 20:50

What do we need here to set this up?

Dr. Michael Koren 20:52

This government initiative should make all the difference. Again, because companies that now do their research work in the United States will get quicker access to our market, that's a huge incentive. So I think that will probably be all the government needs to do to bring a lot of this work back to the U.S.

Eric Ross 21:11

Okay, Dr. Michael Koren, there's so many credentials I can't read them all. Host of MedEvidence, awesome show, all the things that go with it. Medical research, again, your credentials are so long I can't read them. A couple minutes left. What is some fun stuff? Like, man, this is fun you'd like to see happen in healthcare in the United States in the next couple years.

Dr. Michael Koren 21:29

 

Why Health Tech Has Not Improved Outcomes

Dr. Michael Koren 21:30

Fun stuff.

Eric Ross 21:31

Well, not more boner pills, by the way. There's enough hymns and Viagra and all the things.

Dr. Michael Koren 21:35

Yeah. Well, I I would say that we need to make information portals in healthcare much better than they are right now. So we're in an interesting situation in terms of the interface between information technology and medicine, in my humble opinion. We have uh amazing capabilities in information technology, but they have not changed outcomes in medicine at all. So if you actually look at the data, you see that cardiovascular death rates and cardiovascular morbidity rates, which is things short of death, have come down dramatically between the 1970s to around 2010. And then since 2010, there's been a flattening of the curve, actually snuck up a couple of years, but we really haven't made any progress after dramatic improvements in these things over 40 years. And that coincided with the development of electronic medical records and a lot of other technologies that for a number of reasons have not resulted in better outcomes. And I, you know, I think there are reasons behind that. And I think part of the reason is that we need for these technologies to become more seamless. Too siloed. Yeah. Siloed is is definitely part of it. And you know, just very, very simple things like getting a prescription filled. Right? Is that any better now than-

Eric Ross 23:02

This is an hour long conversation by the way

Dr. Michael Koren 23:02

 

Dr. Michael Koren 23:02

is that any better now than what it was 30 years ago? I don't think so. In fact, I think in some ways it's less good. And I'll tell you why. And this is an example I've given in multiple presentations. We were talking about the old statins, lova statin, lipitor, etc. So when I started practice in the 90s, I would take out my prescription pad and they would say, Well, your cholesterol is bad and you had a heart attack. We need to do something about it. And in front of the patient, I wrote a prescription. I gave them that prescription, and I said, Please take this every day. Right? That's a very powerful interaction. And the patient would take it, go to the pharmacy, get it filled, and they would probably feel that they immediately acted on what their doctor's advice is. Okay. What happens now? Oh, okay. Well, yeah, you have a cholesterol problem. Yeah, yeah. Well, so we're gonna put something in for you, don't worry about it, we'll take care of it. So just go to the pharmacy and pick it up. Okay. That's not as powerful. That is not as not as powerful. So this and they'll say, oh, well, I couldn't get to the pharmacy, or that's my mail order, and I have to get on uh figure out how to get to

Eric Ross 24:11

Does my insurance cover it. What's the cost through insurance versus cash pay?

Dr. Michael Koren 24:13

Right, right. So so so all these things basically result in fewer patients getting their medicine as quickly as they did previously in many cases. Now, not to say that it's all bad with the way the system is now, but you can see that some of the power of the interaction has been diluted with the new technologies.

Eric Ross 24:30

Oh my goodness, Dr. Michael Koren, there's so many credentials. I can't say them all. We are going to mention MedEvidence magazine also. I didn't know y'all did a magazine. Shout out. ENCORE Medical Research. That's What the Health Just Happened. That's what the Health Just Happened. Welcome back to the second half of What the Hell Just Happened. If you're here on the radio station, good news is you can catch the full episode on your favorite podcast or YouTube under What the Hell Just Happened. My goodness, we have Dr. Michael Koren here. His credentials are so long, I can't go through them again. It's ridiculous. Harvard, MIT, Cornell, Cardiologist. You're again, you get you got a lot of stuff going on. ENCORE, Med Evidence, those are the two biggest things. Medical research, we hit that. Some cool stuff happening, maybe some not cool stuff happening. We got to do this more often. I think reoccurring segments with MedEvidence and What the Health for sure. You all are experts, we're just kind of asking silly questions. Getting the word out. No, getting the word out. Healthy or not healthy. I got it.

Dr. Michael Koren 25:26

Let's just make that point is that you can have the greatest research in the world, but if you don't get the word out, it ain't going anywhere.

Eric Ross 25:32

You could have the best videos in the world. If no one sees it,

Nicotine Pouches And Dopamine Loops

Eric Ross 25:35

it doesn't matter. Yep. We'll hit that too, actually. I like that conversation. Determining like who does the information have to get in front of, who needs to walk in these doors and do the research, who needs to do the trials. I have to ask for me, healthy or not healthy, Zyns.

Dr. Michael Koren 25:49

If you're going to give me a choice, I would say not healthy unless you're comparing it against something. So if you're saying Zyns versus cigarette smoking, healthy. Zyns versus just a good old diet and exercise program, not healthy.

Off Camera 26:02

Fair enough.

Eric Ross 26:02

I use my example, chewing tobacco for years. This is more healthy than that. I'm aware of it, but young kids who are going straight to Ziys don't do it. Yeah.

Dr. Michael Koren 26:10

Yeah. I would say I would agree it Zyn is less unhealthy than chewing tobacco.

Eric Ross 26:16

Less unhealthy. What's that?

Off Camera 26:18

What's the attraction for young kids?

Eric Ross 26:21

I think it's that's a buzz vice. Yeah, it's a it's a buzz. It's a quick it's the same as a cigarette smoker at 14 to 16 years old. That's what I'm guessing.

Dr. Michael Koren 26:29

Yeah, that the the neuroscience of that has been worked out. Nicotine gives you a little dopamine burst. Which by the way, people get on social media also. That's why social media is addictive. Right. It's the same thing. It's these dopamine bursts, and you're that's what a gambler gets. These are things that become highly addictive for everybody, and that nicotine does the same thing chemically rather than situationally.

Eric Ross 26:50

They're passing the mic over there. I love this. Go Jay, chime in, chime in. Healthy or not healthy.

Off Camera 26:54

What? I can't be watching them.

Eric Ross 26:56

They're okay. Healthy or not healthy, the Med Evidence show. The healthy, healthiest thing you can ever watch. The help yours is very healthy, in the weeds, very specific. What kind of guests do you want on the show?

Dr. Michael Koren 27:09

Guests. We have guests that are patients. We have guests who are physicians. We have guests who are scientific experts. We have guests who are public health figures like Dr. Fauci. So we've covered a lot of ground. What is an ideal guest?

Eric Ross 27:24

Go ahead, Trey. Yeah. Yeah. Patients come on and talk about their experience, et cetera.

Dr. Michael Koren 27:31

Yeah. Patient advocates for a number of things.

Off Camera 27:33

I've had a blast when he interviews some of the guys he went guys and gals he went to college with from Harvard. Because a lot of them are entrepreneurial like himself and have gone in multiple different directions.

Eric Ross 27:42

Healthy or not healthy, the USA's performance in the World Cup.

Dr. Michael Koren 27:46

Ooh, that is a tough one. It started out very healthy. Yes. And then it kind of fizzled. So I would say that overall they did what was expected. So they had the life expectancy in the World Cup that we probably thought would occur when we started, but not what we thought that would occur after the first match.

Eric Ross 28:08

It was a good run. Yeah. It was exciting. And then it wasn't. That's kind of how it was here.

Dr. Michael Koren 28:14

Well, it was a very disappointing final match. They did not.

Eric Ross 28:18

Yeah, it was tough. Which brings you to my next

World Cup Tickets Gone Wrong

Eric Ross 28:20

healthy or not healthy: buying tickets for the World Cup on Stub Hub.

Dr. Michael Koren 28:24

Very unhealthy.

Eric Ross 28:24

Unhealthy.

Dr. Michael Koren 28:26

Extraordinarily unhealthy.

Eric Ross 28:27

Rarely do we say turn your phone on. I hope they call, but explain the situation you're going through right now.

Dr. Michael Koren 28:32

So I'm a big soccer or football fan, European football, of course. And I played competitive soccer here in Northeast Florida for 20 years, recently retired because of injuries. And of course, I wanted to go to the World Cup, and I wanted to go to the World Cup finals as a bucket list item. So on September 11th, 2025, as soon as I heard that the World Cup tickets were available, I got on StubHub and I bought four tickets for the finals at MetLife Stadium in New Jersey. After fees, et cetera, et cetera, they're a little bit over $10,000 each. A ticket. A ticket, each ticket. Okay. I bought four tickets, and I was put in section, I got tickets for section 128, which is in the lower bowl. So that was one of my requests to get in the lower bowl. There was obviously selling tickets all over stadium, but I wanted to be in the lower bowl. Now they weren't 50-yard line tickets. They were a little bit to the side of the street. They were good tickets. But they're good tickets. 128. Okay. All right. So I'm really excited about it. Couldn't be happier. You're going to be going with my soccer buddy, et cetera, et cetera. And but StubHub hasn't produced the tickets, and it's getting closer and closer to the time of the tournament, no tickets. And they say, Don't worry, don't worry, you're going to get them. You'll get them before July 19th, which is the day of the match. I said, Hopefully I'm going to get them before July 19th. But they didn't tell me. So finally, in the middle of June, I get an email from them say, oh, sorry, the seller did not deliver the tickets. So do you want your money back or a replacement? They said, Well, I I have already made plane reservations and I've already made hotel reservations, and I'm all excited about this. Of course, I want replacements. I don't want my money back. All right, so but I don't hear what the what tickets are going to get instead. So finally, after another couple of weeks, I get word that, oh, these are your new tickets, but instead of being 128,

Eric Ross 30:21

you're now in section 1047.

Dr. Michael Koren 30:24

Yeah, close to that. But in the in the You could watch from the bar down the street. Yeah, I can actually pull it up from my FIFA app.

Eric Ross 30:31

This is the one example where like keep your phone on because if they call, you have to answer this.

Dr. Michael Koren 30:35

Right. So here you can see it. Oh my goodness. All right. These are the actual tickets. And and I had to go through the FIFA app to even find out where the tickets were, because StubHub didn't tell me where they were. Section 323, row 24. And there are only 26 rows in the stadium, in that section, on the top of the of the stadium. So two rows down from the top, the very, very top of the stadium, compared to where I started, which was section 128, right in the lower bowl.

Eric Ross 31:01

Nine months ago.

Dr. Michael Koren 31:02

Yeah, nine months ago, right. So we we're still awaiting how they're going to resolve this issue. I was told on Thursday that they would replace my initial good tickets with something that was similar rather than these, but the jury is out on that.

Eric Ross 31:17

Oh my gosh, there's so much to unpack here, right? You gave an example. I'm kidding, I would be so pissed off, by the way. You gave an example like how does this apply to healthcare? What you're going through right now, you gave a great metaphor for that.

Dr. Michael Koren 31:30

Right. Well, I I I would hope that something like this would never happen in healthcare, just to be clear. Obviously, I'm biased as a healthcare provider my entire career. But imagine you want some plastic surgery, right? You don't have to get plastic surgery, but you really, really want it, and you're successful and you can afford plastic surgery. You go to a surgeon and you put down your $10,000 deposit for your nose job or your breast reduction or whatever the case may be.

Eric Ross 31:56

I'm going implants. That's what I'm trying to do.

Dr. Michael Koren 31:57

Okay, whatever case.

Eric Ross 31:58

Calf implants.

Dr. Michael Koren 31:59

Let's use nose jobs. So as you know, to go to plastic surgeon, you have to use it, you give them a deposit, and then you uh the the day of your pre-op visit, which is now months after you gave the deposit, they say, Oh, the the facility is not able to do nose jobs right now, but we're gonna give you Botox injections for the same price. And you and you and and you're gonna look good, you're gonna look so good that no one will notice your nose.

Eric Ross 32:24

Oh, that's a great, great metaphor for that.

Dr. Michael Koren 32:27

So that's that's what happened to me with StubHub. So I'm still trying to get that nose job. We'll see what happens.

Eric Ross 32:32

Stub hub is not healthy, by the way. Last uh soccer slash football question. Who are you pulling for to win it all?

Dr. Michael Koren 32:39

Good question. Well, of course, I was a huge US fan, and uh it's unlikely they're gonna win it all at the end.

Eric Ross 32:44

I don't think they're gonna make it. Yeah.

Dr. Michael Koren 32:47

I don't think they're gonna make it. Right. So of the teams that are left, I'll probably pull for England. Either way, going to this is I think France is going to win, but but I believe and at the beginning of the tournament, I predicted France, Argentina final, a repeat of the last time.

Eric Ross 33:03

But as a fan.

Dr. Michael Koren 33:03

But France will win this time instead of Argentina.

Eric Ross 33:06

And consumer, you're just excited and thrilled to go. Hopefully, if things work out.

Dr. Michael Koren 33:10

Yeah, although this this whole issue with the tickets has put a huge damper on my enjoyment, to be honest with you.

Eric Ross 33:14

That's

Gene Editing Enters The Clinic

Dr. Michael Koren 33:15

tough. That's tough.

Eric Ross 33:16

Let's pivot here. I feel like you all are working on something pretty cool with genes.

Dr. Michael Koren 33:21

Yeah, gene editing.

Eric Ross 33:22

What's it? That's it.

Dr. Michael Koren 33:23

Gene editing.

Eric Ross 33:23

Gene editing. I know, I'm kidding. I can't use that term right there, you say, because it matters.

Dr. Michael Koren 33:27

Well, there's there's brand names. Uh you know, a couple of brand names out there. CRISPR is one of the brand names as a company that's developed certain technologies. Another one's called Verve. We're working with both of them now. But the the actual name is gene editing.

Eric Ross 33:41

So again, really dumb it down for us. If you're not familiar with gene editing, this is could be considered the future of healthcare. It's been happening for a while.

Dr. Michael Koren 33:50

Oh, it's incredibly exciting. So the concept of editing genes, basically getting rid of the genes that cause trouble, has been out there for a while. And we've tried different things in the past and they haven't really worked out. But over the last two decades, there's been a number of Nobel Prize-winning innovations that are now being put together to actually make gene editing practical and something that'll change lives. So you mentioned CRISPR, for example, and CRISPR has a product on the market for sickle cell anemia. Now that's a type of gene editing that occurs outside the body. So for that particular product, they take the bone marrow of somebody with sickle cell, and then they treat it outside the body, get rid of the bad gene, quote unquote, and then put the product back in the body where the it fills up the bone marrow and you go on on your merry way, but now you don't have the sickle cell problem.

Eric Ross 34:45

So the bad gene forever or continuing to take this bone marrow replacement.

Dr. Michael Koren 34:49

Yeah you replaced, you fixed the gene that was causinh the sickle cells. Go ahead, Trey.

Off Camera 34:54

Rough cost on something like that? I know we're on the beginning page.

Dr. Michael Koren 34:56

Two million dollars a patient.

Off Camera 34:58

But that changes someone's compl their entire life.

Eric Ross 35:03

I don't have the information in front of me, but you might spend two million dollars in your lifetime or more treating sickle cell.

Dr. Michael Koren 35:09

Right. But the the problem is that it's a third party that has to pay it for most people. So yes, if you have a couple million dollars in cash, sure, you can get that done. But obviously, there's a lot of ethical issues about who's going to pay and and how few people really have those funds to pay that.

Off Camera 35:24

But just like anything, those prices will come down. Yes.

Dr. Michael Koren 35:28

They will, but it'll come down very, very slowly because it is so expensive to develop these technologies. It took years and decades to get that market. So these companies have to be very disciplined and and you know try the best they can to be humane, but at the same time get a return on their investment. Understand.

Eric Ross 35:44

One example, sickle cell, taking bone marrow out, gene editing, putting it back in the code.

Dr. Michael Koren 35:49

But it's done outside the body. So now what we're doing is we're doing gene editing inside the body, where we're giving a product

Eric Ross 35:58

endogenous, is that the right term or exogenous?

Dr. Michael Koren 36:00

It's called in vivo or ex vivo.

Eric Ross 36:02

In vivo, ex vivo.

Dr. Michael Koren 36:03

Right.

Eric Ross 36:04

Okay.

Dr. Michael Koren 36:04

Right. So vivo meaning in the body. So ex vivo is outside, in vivo is in the body. And what these technologies involve is targeting a gene that we know causes problems, but that's not necessary for normal human functioning. So the two genes that we're working on right now is one called PCSK9, which is a gene that leads to very high cholesterol levels. And people who don't have PCSK9 functioning in their bodies or the genes that make it functioning in their bodies live perfectly normal lives, except they don't have heart attacks or strokes. And similarly, for another gene called ANG PTL3, which is more focused on triglycerides, is another gene that if you don't have it, if you were genetically made that you don't have this gene functioning, you seem to do just fine with fewer cardiovascular problems. And in both of these cases, there are drugs, pharmaceuticals on the market that target that problem, neutralize that problem, and have beneficial results. So there's a lot of good parts to this story that we know that that gene is not necessary for normal life, and that reversing the action of that gene product results in improvement in life. So why not do something where there's one treatment and you're set for life?

Eric Ross 37:24

Forever.

Dr. Michael Koren 37:25

Right? And that's what we're doing now. And so what this involves comment?

Off Camera 37:29

No, I was just gonna ask real quick, how many gene editing procedures do you think have happened just for like for for my sake? Like, yeah, just successfully.

Dr. Michael Koren 37:38

Oh, the CRISPR is the one that's that's been on the market. I don't know all the details about others, but there's some stuff in cancer that's been going on. I couldn't tell you exactly how many approved products there are. It's it's a handful at most.

Off Camera 37:51

Okay.

Dr. Michael Koren 37:51

Yeah.

Off Camera 37:51

Fair enough.

Dr. Michael Koren 37:53

Yeah. It's the yeah, I I see the research, but I don't always know when they actually get approved. Fair enough. But it's it it's less than 10.

Eric Ross 38:00

Okay. So so back on track, you you have an option instead of spending decades potentially, seven to fifteen years to get a drug to market, this is one solution

In Vivo Cholesterol Edits And 15-Year Follow-Up

Eric Ross 38:10

that can eliminate something for the rest of your life.

Dr. Michael Koren 38:12

Theoretically, and hopefully, yes.

Eric Ross 38:14

Which again is a higher cost, I would guess. It eventually takes time.

Dr. Michael Koren 38:18

So as we speak, in this building that we're all sitting in, we're

Eric Ross 38:22

right here in Jacksonville, Florida,

Dr. Michael Koren 38:23

right

Eric Ross 38:24

ENCORE.

Dr. Michael Koren 38:24

Right. We are doing this work. And we actually have the product uh available for people that are interested in learning more about this.

Eric Ross 38:33

This is fascinating to me because this is in our backyard. And the show we do like expands other markets, obviously. But you're doing this stuff in Northeast Florida.

Dr. Michael Koren 38:42

Yes.

Eric Ross 38:43

Which is state of the art, impressive. Who needs to know about this? Is it is it patients, is it doctors, is it investors?

Dr. Michael Koren 38:52

Well, patients and doctors. The invest the investment has already been made. But it's it's remarkable technology. Now it's not for everybody, and I will be the first to say that if your situation is under really good control, just be thankful. On the other hand, there are some people that have very aggressive atherosclerosis that this can be very beneficial for. And just getting a little bit more into the mechanism, people would be very, very carefully screened, make sure that their liver is fine, make sure that they don't have any other general medical problems that can cause trouble, and they come in, they get an infusion probably for four to six hours of this product, and I can go into some of the details of that in a second. We monitor them for a couple days, and if everything looks good, they go home and hopefully that gene has been edited in the liver, and they should go on and have fewer complications based on these bad gene products that have been corrected.

Off Camera 39:47

What is the [incomprehensible] for the patient? What is their feedback like what is their feedback regimen to giving to you guys? So once they leave here, how how much are they in touch with you guys on a day?

Dr. Michael Koren 39:58

Oh, we're gonna follow them for 15 years.

Off Camera 39:59

Oh wow. Wow. So there's a there's a relationship that's uh there for the case.

Eric Ross 40:04

Yeah, yeah. This is the story that I'm trying to paint too. So very specific, it's the tri triglyceride example you gave. Hey, you you fit this criteria, you should maybe consider this program. They come here and do all the testing, a bunch of stuff before they flip the switch on and take it. Is that correct?

Dr. Michael Koren 40:20

That's correct. Yeah.

Eric Ross 40:21

That's a month, three months, six months.

Dr. Michael Koren 40:23

Hopefully between two weeks and two months.

Eric Ross 40:26

So so Eric Ross has terrible triglycerides, my genes are a mess. I do all the things right. I check all the boxes. I come in and you all test me.

Dr. Michael Koren 40:35

Yeah, we would get consent. We always start with consent, and we actually even have a preliminary protocol. It's all covered by a study grant, doesn't cost you anything to do any of these things. We would do start doing medical testing that the study would pay for, including coronary artery tests, liver tests, blood tests, et cetera. And then we analyze everything. And if you look like you're a good candidate, then we move on to the next step, which is actually enrolling in the study.

Eric Ross 41:02

And then the study you said, let's say it's four-hour infuse, stay here a couple days to make sure everything's okay, no major side effects. And then once that's cleared, you go home and stay in touch with these patients, clients.

Dr. Michael Koren 41:17

Yeah, we'll we'll do very regular follow-ups in the beginning, but we plan on touching base with all of our patients for the foreseeable future, which the FDA has outlined to be 15 years.

Eric Ross 41:28

And that's the that's ENCORE from its inception in 97. In this instance, it's gene editing work.

Dr. Michael Koren 41:34

We've done other gene editing work, not this generation of gene editing work. This is this is new. These are products that have been tested in fewer than 100 people around the world so far.

Eric Ross 41:44

I think the bigger picture for me is individuals that may have a medical complication, they have an opportunity to try something different that could work.

Dr. Michael Koren 41:53

Yeah, absolutely.

Eric Ross 41:54

How do you find out about what's happening, get access to it? Not just Jacksonville, Northeast Florida, but if you live in Wisconsin.

Dr. Michael Koren 42:08

Oh we get calls from Wisconsin and all over the place. So that's actually something that is very time consuming. So we we try our best to answer all the inquiries, but I've fielded calls from all over the country. And there's one person from outside of Jacksonville that's gonna come down here. But I have to tell them that the expectation is that we're gonna follow you here for an extended period of time, which is not something that's gonna be easy for a lot of people.

Eric Ross 42:28

Logistically, is there a way to expedite this process? Probably not. Because it takes time. Yeah, so it was.

Dr. Michael Koren 42:34

But the other thing is that it's still very early on, so you have to build confidence with these things. And the more you do it, the easier it gets, and then you figure out how to really focus on the most important safety issues and logistical issues, and maybe put the other things at abeyance.

Eric Ross 42:51

1997 it opened, so I'm not gonna do math there, 30 years, basically. What are some of the biggest advancements you've seen in that

Statins And GLP-1s As Heart Drugs

Eric Ross 43:00

period? Like wow.

Dr. Michael Koren 43:01

Well, the cholesterol, the whole cholesterol uh drug environment is dramatically different than it was when we first started. And statins are wonder drugs. They don't get a lot of good PR these days because the drug companies have stopped promoting them and all you hear about the side effects, but they're literally wonder drugs.

Eric Ross 43:19

Well, influencers online, we talked about that. They're talking about what's bad about statins.

Dr. Michael Koren 43:23

Yeah, but they're remarkable drugs that literally have saved millions of lives. I like to say that the number one side effect of statins is that you live longer.

Eric Ross 43:33

Okay, yeah, I like that.

Dr. Michael Koren 43:34

Yeah, and uh the GLP-1s is another great example. I read somewhere that close to 12% of the American adult population is on a GLP- 1 at this point.

Eric Ross 43:44

Currently. One in nine Americans are taking a GLP-1.

Off Camera 43:47

Really?

Dr. Michael Koren 43:48

And it's it's it's so prevalent now that food companies are saying that their earnings will not be as good as they expected because of the effective GLP-1. So fast food restaurants are predicting. Predicting lower cells because of it, and other food companies are saying the same thing. So it's remarkable. And that started with diabetes research. So interesting story. Diabetes drugs that were developed 30 years ago were pretty good at controlling the immediate complications of high blood sugar, but not so good at preventing cardiovascular problems down the road. And there was a disconnect there because we know that diabetes puts you at very high risk for cardiovascular complications. So you would assume that just correcting the sugar should reduce that risk. But it really wasn't doing that. People are still having heart attacks and strokes. Things move on, and then there were certain diabetes drugs that came out that we thought were good at controlling sugar, but actually maybe causing adverse cardiovascular problems. So any benefit from sugar lowering on the cardiovascular system was offset by harm from the side effect of the drug. So the FDA started to mandate that all diabetes drugs went through vigorous cardiovascular safety before diabetes drug can get on the market. And then the GLP-1s came out, and the FDA said, well, you got to go through this process. And that's when I first got involved probably 15 years ago. And we started doing studies on semaglutide, otherwise known as Ozempic. And we were looking specifically to make sure that people didn't have heart attacks or strokes when they took this for their diabetes. And lo and behold, when we started looking at these drugs, not only were they not having heart attacks and strokes, but the people on the medication were having lower blood pressure, lower cholesterol, and fewer cardiovascular complications. And that became a snowball effect that every study showed the same thing over and over again. And now GLP-1s are not even considered diabetes drugs anymore. They're now cardiovascular drugs that reduce cardiovascular risk, hypertension, and cholesterol. You so much to um with along with obsessive compulsive disorders and a bunch of other things.

Eric Ross 45:59

There's so much to unpack. I I knew this would happen. There's 800 things we talk about. But you said something that I

The Future Of Fixing Bad Genes

Eric Ross 46:05

want to go back to. So you've been researching and working in semaglutides or Ozempic in this example for 15 years. Plus, yeah. That's so people don't understand that this is I've never seen anything in the health and wellness biohacking longevity explode like we say peptides, peptides. GLP-1s for sure. You've been researching this for 15 years.

Dr. Michael Koren 46:25

Yes.

Eric Ross 46:26

This is not some flash in the pan. You have dec a decade and a half of research on this.

Dr. Michael Koren 46:31

Yes.

Eric Ross 46:33

Which is exciting. Okay. This has to be the last question because we could talk forever. 30 years you've been doing this. Yes. I believe in you. You could do this for 30 more years. I hope.

Dr. Michael Koren 46:44

Maybe.

Eric Ross 46:44

Maybe. What are you excited for? You look out, I'm assuming this is part of it, but what else is like this is going to change the health industry? Stuff that we're currently researching.

Dr. Michael Koren 46:55

Well, it's funny. I I would always joke that one of the most important things in life from a health perspective is to pick good parents.

Eric Ross 47:06

If only. I mean, I love my parents. I love you, mom.

Dr. Michael Koren 47:09

And that may not be true anymore because you can actually change the genes that you don't like. Imagine that.

Eric Ross 47:16

That's scary.

Off Camera 47:18

That's exciting.

Eric Ross 47:19

I mean, that not that's the wrong term. Is there a scenario where a parent says, you know what, I want to eliminate this, but I want my kid to have blue eyes?

Dr. Michael Koren 47:27

Well, again, we're I'm being somewhat facetious because we're we're talking about a very specific set of genes that have adverse health effects. This is not eye color. And remember, gene editing, and this is a very important point that we're doing, is just affecting the genes in the liver and no place else. So it doesn't change your germ cells with uh your ovaries or your testicles or your sperm. So it doesn't have effects there, specifically for the liver. So again, there's a little facetiousness in what I'm saying. But some of these adverse genes that do run in families, like there's a condition called familial hypercholesterolemia, that is fairly common in terms of a genetic disorder. One in 300 people approximately have this disorder in the United States. And that may be something that is completely curable with gene editing therapies.

Eric Ross 48:18

I knew this would happen. There's so many things we could talk about. And the clock is counting down. Dr. Michael Koren, MedEvidence ENCORE. Again, your credentials, I might have to put these in the show notes. You've had a hell of a career to date. Oh, thank you. Another 30 years of this?

Dr. Michael Koren 48:33

I hope so. If I take my statin.

Eric Ross 48:34

Statin, or that's right. And you don't deal with Stub Hub, right? How much does stress impact the longevity? Yes. Y'all have been great. This is a couple times we've we've done some stuff together. I think we should do this more often, honestly, collaborate for sure. But Dr. Michael Korn, thank you for joining us. That's What the Health Just Happened.