Latest / Lab to Lives / If Your Medicine Arrives With A Screwdriver, It is Counterfeit w/ David Chametzky

Transcript

If Your Medicine Arrives With A Screwdriver, It is Counterfeit w/ David Chametzky · Lab to Lives

• 0:10
  SPEAKER_01: Welcome to the African library, the podcast and how do we get great ideas to add a library and interactive library?
• 0:24
  SPEAKER_01: We are key industry, and if I don't need it, we are interested in media industry and also working lifetime.
• 0:33
  SPEAKER_01: On this show, we invite guests from the industry to give us their both needs and how we could get more health with less waste.
• 0:44
  SPEAKER_01: So whether you're developing a next generation drug, innovating in MedTech, or just curious about how healthcare moves from discovery to impact, welcome to Lab2 Lives.
• 0:59
  SPEAKER_01: Welcome to another episode of Lab2Lives.
• 1:03
  SPEAKER_01: Today, my co-host is Chiara.
• 1:05
  SPEAKER_03: Hi everyone.
• 1:06
  SPEAKER_03: Nice to see you everyone again.
• 1:08
  SPEAKER_01: And I am Ivana.
• 1:09
  SPEAKER_01: In the studio today, we have Dave.
• 1:12
  SPEAKER_01: Welcome, Dave.
• 1:13
  SPEAKER_01: We've been so excited to have you.
• 1:14
  SPEAKER_00: Hey, how's it going?
• 1:16
  SPEAKER_01: Dave and I actually met a while ago when we spoke on your show, Dave, which was an amazing experience.
• 1:23
  SPEAKER_01: And we spoke about something completely different than the live sciences industry.
• 1:27
  SPEAKER_01: And then during the recording, we both learned that we're actually industry, uh industry buddies and that you have some super interesting experiences from the industry.
• 1:38
  SPEAKER_01: So I had to have you on Lab2 Lives too.
• 1:40
  SPEAKER_01: So so happy that you're here.
• 1:42
  SPEAKER_00: Yeah, I'm so honored.
• 1:42
  SPEAKER_00: Yeah, I remember our conversation and you know brings me back to you know some of the things that I did and recognized the work that I had done over the years.
• 1:51
  SPEAKER_00: So, Dave, where are you right now in the world?
• 1:54
  SPEAKER_00: I'm in my basement.
• 1:56
  SPEAKER_00: Uh like I mean, I mean I'm I'm around New York City.
• 2:00
  SPEAKER_00: So if you're familiar, like you know, I'm I'm I know people are you know, you know, uh might not be familiar with uh exactly where I am in Massapico.
• 2:07
  SPEAKER_00: It's about a half hour east of I know.
• 2:11
  SPEAKER_00: Oh, okay.
• 2:13
  SPEAKER_03: I know because yeah, that's a fun fact to start with.
• 2:15
  SPEAKER_03: Like my family, my my dad's sister, Italian, uh, she moved there about four, I don't know, 35 years ago.
• 2:23
  SPEAKER_03: And so I've been there many times because they lived there in Massapico Park.
• 2:27
  SPEAKER_00: Yeah, okay, Massapo Park.
• 2:29
  SPEAKER_00: Yeah, you know, the the one of the things that they uh make fun of, at least traditionally, it was always a very high Italian neighborhood.
• 2:37
  SPEAKER_00: I mean, like right down the street from my house is all these uh great Italian food places.
• 2:42
  SPEAKER_00: It used to be a little bit of a Jewish population, uh it's less more now, but uh they used to call it Mazza Pizza as Massapequo.
• 2:51
  SPEAKER_03: So I didn't know about that, but I've visited it.
• 2:56
  SPEAKER_03: Yeah, no, it's a great neighborhood.
• 2:57
  SPEAKER_00: I I I walk through I walk through Massapequa Park all the time.
• 3:02
  SPEAKER_03: We still have uh a cousin living there, so close what are the odds?
• 3:06
  SPEAKER_03: Yes, what are the odds?
• 3:07
  SPEAKER_01: I nobody knows this place, but here we go.
• 3:10
  SPEAKER_01: There you go.
• 3:12
  SPEAKER_01: What an amazing way to get started.
• 3:14
  SPEAKER_01: Dave, what are you uh currently up to?
• 3:16
  SPEAKER_01: And to our listeners who are listening to this and not uh watching this, I would just say that Dave has an interesting background right now, which looks like a book cover.
• 3:25
  SPEAKER_01: So maybe you can say something about what's happening with that.
• 3:28
  SPEAKER_00: Yeah, so uh uh so I I have an interesting story.
• 3:31
  SPEAKER_00: So I I I worked in legal, I'm not a lawyer, but uh I worked in for 22 years.
• 3:37
  SPEAKER_00: I worked in the pharmaceutical industry, and we'll go into that a little bit more.
• 3:41
  SPEAKER_00: And then due to a lot of things turning around COVID, they reduced staff.
• 3:46
  SPEAKER_00: You know, you became a certain age in pharma many times.
• 3:51
  SPEAKER_00: You're asked to leave, not in a fired way, but in a way that they reduce staff and most of the larger corporations.
• 3:59
  SPEAKER_00: I worked in one of the larger corporations every three to five years would you know would you reduce staff?
• 4:04
  SPEAKER_00: And it came to be my number.
• 4:06
  SPEAKER_00: I I hit it, I hit a certain number age-wise, 55, and they go, Thank you very much.
• 4:12
  SPEAKER_00: They gave me a golden handshake.
• 4:13
  SPEAKER_00: I had a great career.
• 4:14
  SPEAKER_00: I think highly of the organization, so it's not a bad situation, got some great experiences, and that's where you and I had that conversation on the podcast, Peace, Love, and Bring A Bat, to talk about your expertise and how you blend in pharmaceuticals and you know, comedy and and and so much of your expertise.
• 4:35
  SPEAKER_01: It's it's nice to have like people who have many interests.
• 4:39
  SPEAKER_01: It's always a pleasure to meet someone who's like, Oh, you are you are this, but you're also this, and you're also this.
• 4:43
  SPEAKER_01: Oh my god.
• 4:45
  SPEAKER_01: So, what's happening with your book, Dave?
• 4:46
  SPEAKER_00: The background is my book, is the first book I wrote.
• 4:50
  SPEAKER_00: I remember being in elementary school and saying, I want to be an author, I'll never be an author.
• 4:56
  SPEAKER_00: And eventually I put together a book and I had this published by a publishing company, it was a small company, and uh I got my first book.
• 5:04
  SPEAKER_00: And you know, it's almost like holding your child, so completely different.
• 5:10
  SPEAKER_00: Uh obviously, there's there's a little more emotion with a child than a book, but when you put your heart into it, the the name of the book is When Your Heart Says It's Your Time to Soar.
• 5:20
  SPEAKER_00: Now, we all know no matter what careers you've come back into, is that when you did something right, when you maybe got got a degree, maybe got married, maybe your children, you know that that it's like a touchstone in your life.
• 5:33
  SPEAKER_00: And the book was also one of the many touchstones in my life that I look back and I was like, man, I accomplished something that I didn't think I could do.
• 5:41
  SPEAKER_00: So it's a bunch of stories in it about my personal life, but also how I can teach people how to improve their lives.
• 5:48
  SPEAKER_00: You know, one of the stories is about an uh an old girlfriend who got killed by a drunk driver, was my first girlfriend.
• 5:54
  SPEAKER_00: Jesus.
• 5:55
  SPEAKER_00: And you know, so you go through it, but I want us to think about the first love in our life, and it should be us.
• 6:01
  SPEAKER_00: I didn't know that in my instance it wasn't me.
• 6:05
  SPEAKER_00: And and that means we should start love with ourselves.
• 6:08
  SPEAKER_00: And depending on what partner you're with or or where you are in life, can you treat them like your first love?
• 6:15
  SPEAKER_00: You know, that that first, you know, where you get the butterflies and and things like that.
• 6:19
  SPEAKER_00: And it's nice to think, and if it's not, why can't you?
• 6:23
  SPEAKER_00: And that's a conversation, and then you can have other conversations with yourself about that.
• 6:28
  SPEAKER_00: But we go through stages, the beginning stage, that middle stage where most of us uh might be now in that middle stage of life where I'm a little lost, I need to find the right path.
• 6:39
  SPEAKER_00: So, one of the backgrounds of what I do is I work in mental wellness.
• 6:44
  SPEAKER_00: Uh, besides my corporate career, I had some side hustles.
• 6:47
  SPEAKER_00: I had some stuff that I did.
• 6:49
  SPEAKER_00: And uh, how do we get through those obstacles?
• 6:52
  SPEAKER_00: We sometimes can't see how we could do it, and that's why you can't always do it yourself.
• 6:56
  SPEAKER_00: And then, so you know, there's the middle part, there's some middle parts I have a story about perseverance, not only about this book, but my friend Kevin, who wasn't physically fit.
• 7:04
  SPEAKER_00: We went hiking right after my divorce, and I said, Man, no negativity.
• 7:08
  SPEAKER_00: If I hear negativity, I'm I'm I'm leaving you on the side of a road.
• 7:11
  SPEAKER_00: We walked up Nevada Falls in uh Yosemite National Park.
• 7:16
  SPEAKER_00: And for those that don't know Nevada Falls, which many people don't, it's only a two-mile hike.
• 7:21
  SPEAKER_00: And I'm like, okay, he could do that, it's physically fit.
• 7:23
  SPEAKER_00: The part that we neither one of us looked is it was almost 2,000 feet in altitude, so it was not as easy as just a two-mile walk.
• 7:33
  SPEAKER_00: But we got to the top, even though I told them it's okay, I'll take the pictures from the top, I'll tell everybody that you're there.
• 7:40
  SPEAKER_00: But it's times in our life that we need to get through something just for ourselves, like me with the book and Kevin with Nevada Falls, the things that we have to push through that nobody else is gonna give us credit for, but we know we did it, and that's the power.
• 7:56
  SPEAKER_00: So there's a story about that, and then the book ends with uh us having to soar the things that we do to rise ourselves.
• 8:04
  SPEAKER_00: And the last poem I have is about my mom who had passed away, and I would have loved for her to read the book, so I wanted to pay some homage to to my mom and and the journey she was with me along the way, and you know, I've soared even more since that point.
• 8:20
  SPEAKER_03: So much uh thank you.
• 8:22
  SPEAKER_03: Yeah, it's very sweet, and I think there's something you said about really touched me.
• 8:27
  SPEAKER_03: Like, remember our first love, and we should think that as ourselves.
• 8:33
  SPEAKER_03: That's very, very sweet, and I can relate to it.
• 8:36
  SPEAKER_03: Like, I'm like Q.
• 8:38
  SPEAKER_03: Maybe just a bit earlier in my career.
• 8:40
  SPEAKER_03: I was not calmly asked to leave, I was just laid off when I realized after that that it was so much attached to my titles, my achievements.
• 8:50
  SPEAKER_00: You you defined a little bit of who you were.
• 8:54
  SPEAKER_03: Yeah, and I realized like I never really felt like I should love myself just because I am a person that breathes and that was brought to life, and it's it's other so many other things other than a PhD or an MBA or whatever role I was having.
• 9:11
  SPEAKER_03: So that's really an important message, and not just for people in pharma, I think, but or people who get laid off, just people in general to kind of take that perspective of we can be our love no matter what.
• 9:24
  SPEAKER_03: So that's very, very sweet.
• 9:26
  SPEAKER_03: And thanks for sharing so so such vulnerable stories.
• 9:29
  SPEAKER_03: I'm not wanting to read the book.
• 9:31
  SPEAKER_00: That's what I I really feel.
• 9:32
  SPEAKER_00: I mean, so towards the end of my career in in pharma, I remember being at a team meeting, and you know, they did one of the personality tests.
• 9:41
  SPEAKER_00: I was so far off the chart, like where the clut where the cluster is, which is unusual unusual.
• 9:46
  SPEAKER_00: They they said, is this somebody who's new to the organization?
• 9:50
  SPEAKER_00: And I said, No, it's not.
• 9:51
  SPEAKER_00: They they go, usually you don't change your personality, but I go, you do if you experience other things than just being who you are, right?
• 10:02
  SPEAKER_00: Your job is what your job is, and what what do you do?
• 10:05
  SPEAKER_00: And have that open mind.
• 10:07
  SPEAKER_00: And that's where I think farmer needs to to do that more often is to remind us that we're human as well as employees, and the culture, you know, it's a very rigid culture because it's very statistic-based, it's very, you know, fact.
• 10:23
  SPEAKER_00: Is it did the drug succeed in its endpoints or did it not?
• 10:27
  SPEAKER_00: And that's one of those things that putting a little more humanity into at most businesses, not just Brahma, it it will change the world.
• 10:36
  SPEAKER_01: That will make a big difference for how we develop our drugs and which decisions we make based on patience.
• 10:42
  SPEAKER_01: If we can be in our jobs as whole human beings, we will think further ahead, we'll go above and beyond, we'll try to make the right choice and not just whatever task is ahead of us.
• 10:53
  SPEAKER_01: So I think it's like an industry-wide benefit we could have if people were actually showing up as themselves at work.
• 11:00
  SPEAKER_00: So I I was always at at the end when this book came out, and at the end of my career, showing up as myself, who I was, you know, that that's where the pandemic for me was very successful because I I lost the time of commuting and I was working from home.
• 11:17
  SPEAKER_00: I I got to do some Dave stuff, which was really cool.
• 11:20
  SPEAKER_01: The gift of time it can be wonderful.
• 11:23
  SPEAKER_01: Suddenly you can discover passions that were just like crowded out before.
• 11:27
  SPEAKER_03: If you allow yourself to, because I I I remember like after the layoff, for example, I had so much time.
• 11:33
  SPEAKER_03: I was almost forced to deep dive into what I like, like Kiara stuff.
• 11:40
  SPEAKER_03: But I was not really able because I was not allowing myself.
• 11:42
  SPEAKER_03: I was like, oh, but can I do this?
• 11:44
  SPEAKER_03: Like, oh my god, I'm uh you know, I'm a scientist.
• 11:46
  SPEAKER_03: I should not be engaging in I don't know, yoga or whatever other things.
• 11:51
  SPEAKER_03: So because you have that vision or the picture of yourself that you're kind of image that you're trying to somehow preserve for whatever reason.
• 11:59
  SPEAKER_03: So if you allow to, yeah, it's interesting to there, might be many different factors, right?
• 12:04
  SPEAKER_03: It could be society, it could be upbringing, could be just yourself being very strict with yourself.
• 12:09
  SPEAKER_03: Who knows?
• 12:10
  SPEAKER_03: But yeah, if you allow that, time can be a great teacher, a great enabler.
• 12:14
  SPEAKER_00: For sure.
• 12:15
  SPEAKER_01: And allowing yourself to follow the curiosity.
• 12:17
  SPEAKER_01: Like I was just uh reflecting today about when I started doing improv comedy, which was like 10 years ago, and my kids were still small, and like I was so curious to try it that I allowed myself to take an evening or two out a week and go and do improv comedy.
• 12:35
  SPEAKER_01: And it felt just like so pointless and so dangerous because like I had a full-time job, I had kids.
• 12:41
  SPEAKER_01: Like, what am I doing going out trying to learn like this the skill of improvisation?
• 12:46
  SPEAKER_01: Like, what is it even for?
• 12:48
  SPEAKER_01: But just like allowing to myself to follow that curiosity has led to so many good things, also for me in my job, also for me at home, for me as a human being.
• 12:57
  SPEAKER_03: 100%.
• 12:58
  SPEAKER_03: I relate to the improv part.
• 13:00
  SPEAKER_03: I was more like stressed about being like completely mindless, you know, like allowing myself to make mistakes.
• 13:08
  SPEAKER_03: That was one of the big biggest challenges of doing improv comedy.
• 13:11
  SPEAKER_03: It was not just okay to make mistakes, it was encouraged, it was asked to use the mistake, and I'm like, what?
• 13:16
  SPEAKER_03: Oh my god, I said the hand instead of foot or whatever, you know, and then snake all is uh so I really really relate to that as well.
• 13:24
  SPEAKER_01: I think I'll use this as a segue.
• 13:26
  SPEAKER_01: We've talked about mistakes, and they I am just really curious about some of the work that you've done in life sciences in uh tracking down and figuring out what to do with with uh when drugs aren't quite what they seem to be.
• 13:39
  SPEAKER_00: Yeah, so it you know it's amazing to me what we as humans recognize how so many people look at you know the white coat.
• 13:49
  SPEAKER_00: If you show me a white coat on you know on a on a website, man, I'm gonna trust you.
• 13:54
  SPEAKER_00: And I used to say uh as part of my training, my grandfather for years wore a white coat, but the problem was he was a butcher.
• 14:02
  SPEAKER_00: And so we we have to make sure we're not just so naive in what we look at or what things look at.
• 14:11
  SPEAKER_00: And that was you know, always, you know, it got everybody to laugh.
• 14:14
  SPEAKER_00: And uh luckily, you know, the company I worked for, one of their top drugs, was for men's health, let's put it that way.
• 14:21
  SPEAKER_00: So it was also a lot of jokes that we can have around that, and that got the the the guards down, humor, as we both know as we all know, gets the guard down, but it doesn't tell us the real story.
• 14:35
  SPEAKER_00: And so the counterfeiting, I wasn't in the global security department who handled the counterfeiting, but I was there because we had partnered to do a lawsuit.
• 14:45
  SPEAKER_00: The craziest thing that I learned is that within two weeks of a new product coming out to market, it's counterfeited.
• 14:51
  SPEAKER_00: So people already know it.
• 14:53
  SPEAKER_00: Yeah, I I mean I I remember with a smoking cessation drug coming out, and two weeks afterwards.
• 14:59
  SPEAKER_00: Now, the great thing is it with the industrialized nations, there's usually uh a process to get the drug to market, but also how to manage it.
• 15:10
  SPEAKER_00: So, as as you probably know, on the clinical side, each pill is highly regulated.
• 15:15
  SPEAKER_00: You know where it is, you know where it was manufactured and things like that.
• 15:20
  SPEAKER_00: So I used to say the U.S.
• 15:21
  SPEAKER_00: is the gold standard in that way.
• 15:24
  SPEAKER_00: You buy at your pharmacy, yes, you're fine.
• 15:27
  SPEAKER_00: You know, we've only had as far as I know, even in 20 years, 20 plus years, we've only had one instance where it got into the food, the you know, the supply chain.
• 15:37
  SPEAKER_00: It was a small case, and it was a case of somebody who bought it out of the supply chain.
• 15:41
  SPEAKER_00: You know, went to a distributor that was cheaper, and cheaper doesn't always mean better, everybody.
• 15:47
  SPEAKER_00: And that was the one instance that that did happen probably around 2002, 2003, you know, somewhere around that time.
• 15:54
  SPEAKER_00: But the idea behind it is I got to see pictures.
• 15:59
  SPEAKER_00: Like one of the first times I was in a meeting, and so we bought things off the internet uh as part of as everybody would does, all the companies do it, and it said, have a screwdriver ready when the delivery comes.
• 16:11
  SPEAKER_00: Yeah, we were all like, Well, what do you mean?
• 16:13
  SPEAKER_00: I I when I take my medicine, I don't know about you, even though the bottles sometimes used to be hard, I wouldn't have taken a screwdriver.
• 16:20
  SPEAKER_00: Even then it was it was outdated, it came in a transistor radio, like the old time.
• 16:26
  SPEAKER_00: You might not you might not even know what a transistor radio is.
• 16:29
  SPEAKER_00: I actually don't know what that is.
• 16:31
  SPEAKER_00: Okay, so it used to be like if you wanted to listen to music, it would be this like handheld, basically an iPhone that held radio waves instead of you know the the different type of airwaves.
• 16:43
  SPEAKER_00: By the time that I we we had bought this product, it was already like outdated.
• 16:48
  SPEAKER_00: We already had, you know, walkmins and things like it.
• 16:51
  SPEAKER_00: It was like pre-walk min.
• 16:52
  SPEAKER_00: You know, so that shows you how how old, right?
• 16:55
  SPEAKER_00: There's my aunt who who you know is past now, but they were proud when they had their their transistor radio sitting on the boardwalk.
• 17:03
  SPEAKER_00: So this transistor radio comes in, and behind one of the components, you had to unscrew, and that's where your medicine came from.
• 17:11
  SPEAKER_00: And I always go, okay, we were they didn't know that they were sending it to a pharmaceutical company who was doing research on counterfeit medicine.
• 17:19
  SPEAKER_00: What do you see when pills come in away?
• 17:22
  SPEAKER_00: We all know at this point what it should look like when pills come in, when medicine comes in, and when it doesn't look right, what do you do?
• 17:31
  SPEAKER_00: Like that's why having that the belief of all of these today, you know, the GPL one pills.
• 17:37
  SPEAKER_00: Oh, you got a pill here, you got a pill there.
• 17:39
  SPEAKER_00: It's and they don't understand what it takes to get to the medicine.
• 17:43
  SPEAKER_00: That's the indication that I think that all the pharmaceutical companies you know should should talk about of what it looks like, what it takes to get to market.
• 17:51
  SPEAKER_00: And uh, so we would go to counterfeit.
• 17:53
  SPEAKER_00: So I'd I'd see pictures.
• 17:54
  SPEAKER_00: I once saw so the the the the famous blue pill, I saw that they how they made it.
• 18:00
  SPEAKER_00: Well, the counterfeits made it, they made it in a cement mixer.
• 18:05
  SPEAKER_00: I can tell you, and you you both have experience, medicine is not made in a cement mixer.
• 18:09
  SPEAKER_00: Both of you might be a little bit more educated on how to color real medicine.
• 18:14
  SPEAKER_00: These people, these counterfeiters, don't care.
• 18:17
  SPEAKER_00: I saw a cancer product that hey, it had to look yellow.
• 18:20
  SPEAKER_00: They used road paint, uh lead road paint.
• 18:23
  SPEAKER_00: Not that you know, I I used to say lead road paint, and then I was like, it doesn't matter if it was not it was unleaded road paint, yeah.
• 18:30
  SPEAKER_00: It's still the road paint, right?
• 18:32
  SPEAKER_00: It's those things that they don't care, and that's what we need to remind remind ourselves.
• 18:38
  SPEAKER_00: Counterfeits, there's a reason why things cost the way they do, right?
• 18:42
  SPEAKER_00: It's not only for profit, and I can go about why profits are good because all of us who have mutual funds, guess what?
• 18:50
  SPEAKER_00: Your top five companies are the pharmaceutical companies.
• 18:55
  SPEAKER_00: So there's so many reasons, but authenticity.
• 18:58
  SPEAKER_00: When you want to show, when you're showing up in life, it's better to be authentic than to not be somebody who you're not.
• 19:05
  SPEAKER_01: Dave, how close are the counterfeit drugs to the real thing?
• 19:08
  SPEAKER_01: Like, do they use the active ingredients?
• 19:10
  SPEAKER_00: Sometimes it depends on who the counterfeiter is.
• 19:13
  SPEAKER_00: You know, some people will use very little active ingredient because they're they're crushing pills and they're distributing it among their, you know, so it's not full active ingredient.
• 19:23
  SPEAKER_00: And and I also want to say the difference between counterfeit and generic, counterfeit is just making it look like the authentic branded product, whatever that is, versus a generic, which is goes through an approval process, and they have a legal way to get the branded product.
• 19:42
  SPEAKER_00: We learn differently, and that's where we have we can't be so naive in our world in deciding how we get it.
• 19:50
  SPEAKER_00: You know, if you're buying it on the internet, there are risks, and I'm not saying all the internet, there are authentic people, but if it doesn't sound right, or they're trying to teach you, or they're trying to or it comes in a transistor radio.
• 20:02
  SPEAKER_00: Yeah, if it comes in a transistor radio, yeah.
• 20:04
  SPEAKER_00: But you didn't know, you wouldn't know, so you'd be buying it.
• 20:06
  SPEAKER_00: But if it says come in with a screwdriver, ask for your refund right away.
• 20:10
  SPEAKER_03: Um David, do you think that the kind of fate drugs are it's fundamentally a monitoring problem, or is it like a real consequence of the gap that's between the huge demand that we have for patients and the limited access, or maybe the time that it takes to create a drug?
• 20:27
  SPEAKER_00: Some of it might be access in in in some of the lesser places, but they're still not giving you the active the the act.
• 20:33
  SPEAKER_00: So so when you're going to counterfeit, again, there's a difference.
• 20:36
  SPEAKER_00: So there's this gray market, which gray market is let's say we're buying a pill in Canada.
• 20:41
  SPEAKER_00: The Canadian market, they control the price of what the product is.
• 20:45
  SPEAKER_00: So then if you bring it back to the United States, it's a cheaper price versus the United States, which generally is a higher price.
• 20:52
  SPEAKER_00: That's a gray market, that's authentic material, but the counterfeit is making it think that you're getting the real thing when you're not.
• 21:00
  SPEAKER_00: So that's why they copy the package to make it look like a real drug.
• 21:04
  SPEAKER_00: During my career, I worked with the Inter, it's called the IACC, the International Anti-Counterfeit Coalition.
• 21:10
  SPEAKER_00: So it wasn't only medicine.
• 21:12
  SPEAKER_00: And how I explain it, the easiest way is not that I would buy a high-end toilet seat, but they counterfeit toilet seats.
• 21:20
  SPEAKER_00: And I go, if they're counterfeiting toilet seats, they're gonna counterfeit anything.
• 21:25
  SPEAKER_00: And I've been part of investigations where they have had counterfeit brake pads, so you know, even if we take away medicine, yeah, you know, that's why it's so important to make sure where people buy their things.
• 21:37
  SPEAKER_00: So when we go back to medicine, it's going inside you.
• 21:40
  SPEAKER_00: So that road paint, guess what?
• 21:43
  SPEAKER_00: Eventually, the company I worked for and other companies like us, we got calls because of the counterfeit medicine.
• 21:49
  SPEAKER_00: So we have to defend, we have to investigate, defend for a place that you didn't buy it from what we would call an authentic place or within the chain, within the right chain.
• 22:00
  SPEAKER_00: So, yes, some people can't afford it.
• 22:02
  SPEAKER_00: I'm not gonna say that the world has easy access to all medicines.
• 22:07
  SPEAKER_00: And yes, we should all have that in a perfect world.
• 22:11
  SPEAKER_00: But you know, it's still a business.
• 22:13
  SPEAKER_00: And you know, do all the costs, I mean, you guys know the some of the reasons why some of the things cost, right?
• 22:19
  SPEAKER_00: Your investigation, right, Shira, you you're you're a scientist.
• 22:23
  SPEAKER_00: As you know, most of your career was failure, and not because of anything that you did, it was just because of how things go, or the product might have looked well, but then when you started doing testing, things didn't go so well.
• 22:37
  SPEAKER_00: So many different reasons why.
• 22:39
  SPEAKER_00: And even when a product does get to market, guess what?
• 22:42
  SPEAKER_00: Is there's still people who it doesn't work for, it doesn't help, it might have some side effects.
• 22:47
  SPEAKER_00: You know, we all hear those commercials about this is gonna change your life, and then all these horrible side effects, dizziness, diarrhea, and all that fun stuff that they put in there that you're like, I hope I don't get that, but it's a shoot, let's put it that way.
• 23:02
  SPEAKER_01: Yeah, yeah.
• 23:02
  SPEAKER_00: Who stands to profit from the counterfeit drugs?
• 23:05
  SPEAKER_00: So it it it's very similar.
• 23:07
  SPEAKER_00: So there's a lot of uh organized crime, a lot of governments, depending on where you are.
• 23:12
  SPEAKER_00: Again, in a third world nation, they're just trying to get the money going and flowing, and and not every penny goes to where it's supposed to go.
• 23:21
  SPEAKER_00: You know, that's a broad statement, you know.
• 23:23
  SPEAKER_00: So I'm not picking anybody out particularly, but but it's also you won't know.
• 23:28
  SPEAKER_00: So they're not always looking for repeat customers.
• 23:30
  SPEAKER_00: You know, some products you can tell, right?
• 23:32
  SPEAKER_00: If it's for hair growth, you either grew your hair or you didn't, but for cholesterol medication or some other medications, you might not know.
• 23:40
  SPEAKER_00: And that's the big challenge.
• 23:41
  SPEAKER_00: And that's why, you know, reaching back out to some of the pharma companies who have indignant programs to help people.
• 23:48
  SPEAKER_00: That that's where we don't get that out enough.
• 23:52
  SPEAKER_00: There's a lot of programs by a lot of the big companies.
• 23:55
  SPEAKER_00: In fact, I would say all the big companies have indigent programs for people who can't afford medicine.
• 24:02
  SPEAKER_00: And now you still might not qualify.
• 24:03
  SPEAKER_00: I'm not uh saying that they just give it away, but there are many different ways to do it.
• 24:09
  SPEAKER_00: And you know, you know, the the who benefits, it's like anything else.
• 24:13
  SPEAKER_00: It's uh it's if you if you buy stolen goods, person who's selling the stolen goods is doing that, and they are stealing in the intellectual property and the faith.
• 24:24
  SPEAKER_00: It's also morally.
• 24:25
  SPEAKER_00: If the company's moral, yes, they they're still looking for a profit.
• 24:28
  SPEAKER_00: I don't want, I'm not gonna defend big pharma and but they're not gonna try to hurt anybody.
• 24:34
  SPEAKER_03: It is also a bit unfair that then the name of a company goes stained because of some kind of fade.
• 24:41
  SPEAKER_03: I was working in Nobanoris, and we had this issue with the GLP1s that were, and there was a whole work around trying to solve that problem when it's actually not it was not actually caused by Nobanorities back then.
• 24:55
  SPEAKER_03: So there is some sort of unfairness from that standpoint.
• 24:58
  SPEAKER_03: So that's where I comes in my next question.
• 25:01
  SPEAKER_03: When would you suggest that a pharmaceutical company starts the monitoring for this counterfeit?
• 25:06
  SPEAKER_03: Should it be during clinical development?
• 25:08
  SPEAKER_03: Should it be before right before they launch?
• 25:10
  SPEAKER_03: Because it doesn't seem like it was a gonna it worked in the case that you presented the beginning, or should it just be when you have the the product?
• 25:19
  SPEAKER_00: They all the time.
• 25:20
  SPEAKER_00: Yeah, so they do it all the time once a product has been uh approved.
• 25:23
  SPEAKER_00: I mean again goes back to that drug process that when a a drug goes to market, it's not a secret, right?
• 25:30
  SPEAKER_00: Nobody this is not like Apple uh yesterday, which was not a great secret.
• 25:34
  SPEAKER_00: So we'll even use Apple, right?
• 25:36
  SPEAKER_00: Everybody knew before the meeting that they were gonna talk about this new flip phone and things like that, right?
• 25:43
  SPEAKER_00: It somehow it got out.
• 25:44
  SPEAKER_00: Same thing with the in the drug process, we file patents and trademarks.
• 25:50
  SPEAKER_00: So people know they might not know what it's called or why we're using certain certain names, but right, your drug process, you're a scientist.
• 25:58
  SPEAKER_00: Before a drug is approved, that's 10 to 14 years before the market it goes to market.
• 26:03
  SPEAKER_00: That's 10-14 years of patent prosecution.
• 26:06
  SPEAKER_00: There are people who love to the trolls, they look at what patents you have and they try to uh reverse design around it so they can claim, file a patent application, and then say, look, you're infringing on my patent.
• 26:20
  SPEAKER_00: Oh, I don't have all the research, but you know, I thought of it also.
• 26:24
  SPEAKER_00: I I thought of this product, you know, companies have to defend those things.
• 26:28
  SPEAKER_00: I I've been part of lawsuits where you have to defend.
• 26:32
  SPEAKER_00: I created this product, you know, years before you did.
• 26:35
  SPEAKER_00: And and then maybe they had an idea, but you know, you have to document it.
• 26:39
  SPEAKER_00: As a scientist, right?
• 26:40
  SPEAKER_00: You have you have lab notebooks, you have to document when inception in your mind comes and the idea from your inception to where you're actually to figure it out starting to figure it out.
• 26:51
  SPEAKER_00: Again, counterfeits don't do that.
• 26:53
  SPEAKER_00: They're just looking at road paint, you know, cement, baby powder, talcum powder, whatever they can put together.
• 27:00
  SPEAKER_00: That's where I don't know how a correct pill is made, but they do, and they don't care.
• 27:05
  SPEAKER_00: They're just hoping it holds long enough to do that.
• 27:08
  SPEAKER_00: You know, that's why, again, when you go to your your normal pharmacist, you're able to know the the taste, right?
• 27:15
  SPEAKER_00: Even the tasting part of it, right?
• 27:17
  SPEAKER_00: The the extra i incipients that are part of the medicine are already been approved versus these guys who are just putting in, I don't know, this is gonna stick together.
• 27:28
  SPEAKER_00: Good, you know, good, you know.
• 27:30
  SPEAKER_00: That's not the type of stuff that I want to do, and that's why uh letting people identify when there's smoke, there's usually fire.
• 27:37
  SPEAKER_00: One of the other questions I think how can we prevent this?
• 27:41
  SPEAKER_00: It's really hard.
• 27:43
  SPEAKER_00: Especially with these in with these individual packages, the postal services can't handle it, FedEx can't handle like if you say if I send you one package, they can look, they can do all the scanning they want, but they're getting millions of packages.
• 28:00
  SPEAKER_00: But uh the health of everybody is much more important to do that, to have people on staff to make sure that counterfeits we we try to identify it as much as possible.
• 28:13
  SPEAKER_01: So it sounds to me that the identifying of the counterfeit drugs, well, first of all, I'm surprised it sounds like it is pretty prevalent, like that this happens all the time to all sorts of medication, and I'm a little bit surprised.
• 28:24
  SPEAKER_00: You know, some of the stuff bought online now.
• 28:27
  SPEAKER_00: If you go to your your pharmacist, your your your traditional you know doctor who has the you know, that you're gonna be fine with.
• 28:35
  SPEAKER_00: That's where knowing where you're getting it from.
• 28:38
  SPEAKER_00: Are you getting it from somebody who looks like a doctor, or are you getting it from a doctor?
• 28:42
  SPEAKER_00: Are you getting it from somebody who's trained versus hey, I know a guy?
• 28:47
  SPEAKER_01: Yeah, yeah, yeah.
• 28:48
  SPEAKER_01: So it's it's also public awareness in training people who purchase drugs, especially purchase drugs online.
• 28:56
  SPEAKER_01: First of all, perhaps go to the pharmacy instead.
• 28:59
  SPEAKER_01: And then secondly, if something arrives and looks suspicious, like how how should you know what it's supposed to look like?
• 29:05
  SPEAKER_01: It sounds like there's a like some information and education that we need to make available to the general public.
• 29:11
  SPEAKER_00: Oh, well, the great thing is you can Google any drug, uh any any medicine, and say, what does it look like?
• 29:18
  SPEAKER_00: What does this pill look like?
• 29:19
  SPEAKER_00: Uh Lipator or Torvostadin.
• 29:22
  SPEAKER_00: Yeah, you know, so you can see what it looks like.
• 29:24
  SPEAKER_00: So if it doesn't look like that, you can find out.
• 29:27
  SPEAKER_00: But but sometimes generics also, so like with the the the men's product, it was a blue diamond pill.
• 29:34
  SPEAKER_00: Other companies then legally, just generics, you know, made it a square pill, you know, because uh part of the trademark and the trade dress was the the the diamond effect.
• 29:45
  SPEAKER_00: But there's ways to look at it because when you get your medicine in the brown bottle, it says what company it's from.
• 29:52
  SPEAKER_00: So again, it's where you're getting it.
• 29:54
  SPEAKER_00: If you're just getting it in a random bottle, you know, it's like that's where we need to take ownership of how much do we want to put our head in the sand.
• 30:04
  SPEAKER_00: You know, if I'm getting it from somebody who I don't know, some of it might be good.
• 30:08
  SPEAKER_00: I don't want to, you know, you have to test everything, but is it going to be effective for me?
• 30:14
  SPEAKER_01: And it's also another reflection I'm having is some counterfeit drugs turn up as adverse events with the company.
• 30:22
  SPEAKER_01: 100%.
• 30:23
  SPEAKER_00: And that's the the the additional challenge for the company who puts out the medicine is that we you have to take it, right?
• 30:31
  SPEAKER_00: You're you're right, statutory, you have to report your adverse events.
• 30:36
  SPEAKER_00: It's a report, it might be unfounded eventually, but we don't know.
• 30:40
  SPEAKER_00: And a lot of times, those also there's a lot of lawyers out there who go, Well, have you taken this product that had a problem?
• 30:48
  SPEAKER_00: And they become a class action suit.
• 30:51
  SPEAKER_00: So all of these things lead into bigger problems that I don't know how to make the communication other than places like this to talk about becomes why you know it's not just a you make a pill, you get it.
• 31:05
  SPEAKER_00: You don't get it off the shelf.
• 31:06
  SPEAKER_00: We don't go, let's see, I want to make X, and this is what we pull off the shelf.
• 31:10
  SPEAKER_00: This is not focus.
• 31:13
  SPEAKER_01: Very interesting topic.
• 31:14
  SPEAKER_01: I will change topics for us now as we go to the quiz part of the show.
• 31:23
  SPEAKER_01: Uh-oh.
• 31:24
  SPEAKER_01: Uh uh.
• 31:26
  SPEAKER_03: So I'm not great at quiz.
• 31:27
  SPEAKER_03: I have performance anxiety, so I probably I can help you with that.
• 31:32
  SPEAKER_00: I I do stress reduction, so I can I can help you out with that.
• 31:36
  SPEAKER_01: Excellent.
• 31:37
  SPEAKER_01: Well, this stress is part of the fun for me.
• 31:43
  SPEAKER_01: So today I am going to present you with two cases of how an attempt to use AI in the pharmaceutical industry failed.
• 31:55
  SPEAKER_01: And then I'm going to ask you what was inappropriate about that use of AI.
• 32:01
  SPEAKER_01: I think it's a curious case of where we're still trying to find our way with where does AI fit in pharma?
• 32:07
  SPEAKER_01: And it's it's fun when things go wrong.
• 32:09
  SPEAKER_02: Job security.
• 32:11
  SPEAKER_01: So, example number one.
• 32:13
  SPEAKER_01: In April 2026, so this year, uh the FDA issued a warning letter to a cosmetics lab company because they had used AI inappropriately in pharmaceutical manufacturing.
• 32:27
  SPEAKER_01: So, what was inappropriate about it?
• 32:30
  SPEAKER_01: I'll give you some examples, and more than one can be true.
• 32:36
  SPEAKER_01: Option number one: the company did not review documents generated with AI and which they submitted directly to the FDA.
• 32:45
  SPEAKER_01: That's option number one.
• 32:47
  SPEAKER_01: Option number two, the company stated in their defense that they blindly followed what the AI told them to do.
• 32:55
  SPEAKER_01: And option number three is the AI made them write something silly in their submission.
• 33:01
  SPEAKER_01: That's option number three.
• 33:03
  SPEAKER_01: Several of these may be true.
• 33:06
  SPEAKER_01: Which ones do you think led to an FDA warning letter?
• 33:10
  SPEAKER_00: Probably that they based everything off the AI, including making a silly comment.
• 33:16
  SPEAKER_00: Probably B and C.
• 33:17
  SPEAKER_00: But I have a qu I have a bigger question for you.
• 33:19
  SPEAKER_02: Yeah.
• 33:20
  SPEAKER_00: You said a cosmetic company.
• 33:22
  SPEAKER_00: Yes.
• 33:22
  SPEAKER_00: What in the cosmetic company do they I don't think that they have to because that's medicine?
• 33:27
  SPEAKER_00: So what type of cosmetic medicine company?
• 33:29
  SPEAKER_01: Yes, it was indeed a cosmetic medicines company.
• 33:32
  SPEAKER_01: Okay.
• 33:33
  SPEAKER_01: And they their manufacturing was under GMP.
• 33:36
  SPEAKER_00: Oh, okay.
• 33:37
  SPEAKER_00: But I so I I still I still stay with my answer of uh either they had a silly answer and nobody reviewed it.
• 33:44
  SPEAKER_03: I would say the then maybe three of them are correct because the first one was that they just didn't submit documents without reading.
• 33:53
  SPEAKER_03: And if that might probably showed in the fact that AI wrote something silly, and the second one, I forgot what was it, but it sounded it sounded like reasonable.
• 34:05
  SPEAKER_01: I would say the three of them.
• 34:07
  SPEAKER_01: Only two of them are true.
• 34:10
  SPEAKER_01: And it is the first one, they did generate their documents for FDA submission and submitted them without reviewing first.
• 34:18
  SPEAKER_01: And number two, when the FDA questioned them, they said, but the AI told us.
• 34:23
  SPEAKER_03: I mean, this is like a high level of what the hell.
• 34:26
  SPEAKER_00: Right.
• 34:27
  SPEAKER_03: I at least you hide it.
• 34:29
  SPEAKER_03: I didn't want to, I mean, I give them hope to be more reasonable.
• 34:34
  SPEAKER_03: I try to be charitable, but all right.
• 34:38
  SPEAKER_01: For me, it is interesting.
• 34:40
  SPEAKER_01: Like we we do, we we have kind of gravitated to the human in the loop as an industry in general.
• 34:46
  SPEAKER_01: And reading about this company, they were actually trying to do something interesting.
• 34:50
  SPEAKER_01: They were trying to create an AI uh quality department.
• 34:54
  SPEAKER_01: Like, don't hire any humans, only have AI do it.
• 34:57
  SPEAKER_03: Without validating it first.
• 34:58
  SPEAKER_01: That sounds very simple.
• 35:02
  SPEAKER_03: The idea is great, but uh the process to get there is a bit uh has some flaws, let's say.
• 35:09
  SPEAKER_03: Just to type.
• 35:11
  SPEAKER_01: Okay, example number two.
• 35:14
  SPEAKER_01: We have a mid tech company, and this is last year in August 2025.
• 35:21
  SPEAKER_01: They received a warning letter from the FDA for improper use of AI.
• 35:26
  SPEAKER_01: But what was improper about it?
• 35:28
  SPEAKER_01: I'll give you three options, and several of them can be true.
• 35:32
  SPEAKER_01: Your first option is that they misfiled their device, stating that it was a a piece of exercise equipment, but actually it was a diagnostic tool using AI for diagnosis.
• 35:47
  SPEAKER_01: So kind of put it putting things in the wrong box.
• 35:51
  SPEAKER_01: Possibility number two, that they used the data from their manual device to feed it to the AI algorithm.
• 35:59
  SPEAKER_01: Option number three, they they did not file the proper paperwork for the use of their AI in the first place.
• 36:07
  SPEAKER_01: Which of these led to the misfortune of this medtech company?
• 36:11
  SPEAKER_01: And again, multiple can be true.
• 36:13
  SPEAKER_01: Multiple can be true just because I'm evil.
• 36:16
  SPEAKER_03: Man, I need a notebook.
• 36:17
  SPEAKER_03: Some different box, wrong box, diagnostics.
• 36:21
  SPEAKER_03: It was the I always forget.
• 36:23
  SPEAKER_03: I'm always like this, David.
• 36:25
  SPEAKER_03: Like, I need that to repeat three times.
• 36:27
  SPEAKER_00: Yeah, don't worry, I'll put it up on the screen.
• 36:30
  SPEAKER_00: The first one, I'm like the wrong checkbox.
• 36:34
  SPEAKER_00: I don't think I think you could probably train it really well.
• 36:36
  SPEAKER_00: But the other two is so again, B and C, that they use their manual and the man, right?
• 36:47
  SPEAKER_00: So that it it might not know enough about technique, and it would be uh yeah, it's an exercise machine, you know how how it how it looked at it.
• 36:56
  SPEAKER_00: And and then that last one was was what again, I'm sorry?
• 36:59
  SPEAKER_01: That they didn't file the proper paperwork for their AI.
• 37:02
  SPEAKER_00: Yeah, my guess is they also didn't, you know, somebody was gonna be sloppy and is gonna not file the right paperwork.
• 37:08
  SPEAKER_00: You know, it's okay, it's AI.
• 37:10
  SPEAKER_00: Uh they won't know.
• 37:12
  SPEAKER_03: I think the last one I also agree, uh could might be improper use of AI you need to file, and maybe they didn't even know what documents to file in.
• 37:20
  SPEAKER_03: I'm not sure about the submission of data because I guess if they submit data to the AI, there must have been some agreement of data protection, I would hope.
• 37:31
  SPEAKER_03: So I would exclude that.
• 37:32
  SPEAKER_03: So I would say A and C.
• 37:35
  SPEAKER_03: Well, Chiara, you are correct.
• 37:38
  SPEAKER_03: This is what I win.
• 37:42
  SPEAKER_01: Ice cream.
• 37:46
  SPEAKER_01: I'm cheap.
• 37:48
  SPEAKER_01: We can make this happen, but it was in fact misclassifying, stating that the this was a piece of exercise equipment when it was in fact a diagnostic tool using AI as a piece and and not filing the proper paperwork because this is a medical device and not just a piece of exercise equipment.
• 38:10
  SPEAKER_01: So those were the two kinds of uh attempts of using AI in our industry that didn't quite go well.
• 38:16
  SPEAKER_01: My conclusion from researching this is don't fire your quality and regulatory departments.
• 38:25
  SPEAKER_01: You need them.
• 38:27
  SPEAKER_00: And I know that there's instances where uh lawyers have been sanctioned already for basing off of uh quoted materials that didn't exist, that AI created uh ghost uh cases and case law and stuff like that.
• 38:43
  SPEAKER_01: Yeah, it's it's uh it's we're in this like weird transition between what what used to be and what will be, and we're trying to figure out how do we get from there to where we're trying to go.
• 38:55
  SPEAKER_03: And in this transition, it's also quite difficult because there's no one who's really an expert in AI governance, AI, FDA requirements.
• 39:04
  SPEAKER_03: Often when you go and talk to the FDA or these authorities, they they're like, we haven't done this before, it can let's figure this out together.
• 39:11
  SPEAKER_03: So it can be quite a challenge.
• 39:12
  SPEAKER_03: It's a challenging time, but also quite exciting.
• 39:15
  SPEAKER_01: I I agree.
• 39:17
  SPEAKER_01: Dave, it's been such a pleasure to have you with us.
• 39:20
  SPEAKER_01: I've learned uh more about counterfeit drugs and also just gained some awareness about this whole field that I did not spend enough thinking about.
• 39:30
  SPEAKER_01: I I'm also curious, Kara and Dave, any takeaways from your side from this conversation that we've had?
• 39:35
  SPEAKER_00: Well, uh for me, I it was great talking about the stuff that I that I did.
• 39:38
  SPEAKER_00: Uh you know, it's one of those things that even when I started my podcast, I was doing mental wellness and things like that.
• 39:45
  SPEAKER_00: And I love talking about the this this work because I know it, I'm passionate about it, and the information hasn't changed.
• 39:52
  SPEAKER_00: Some of the techniques might have mentioned, so I really appreciated the opportunity for you and Cara to ask me these questions.
• 40:00
  SPEAKER_00: I was like, man, what am I?
• 40:01
  SPEAKER_00: What can I talk about on counterfeiting?
• 40:03
  SPEAKER_00: And I had some things to talk about.
• 40:07
  SPEAKER_03: Oh, you did.
• 40:08
  SPEAKER_03: Oh, you opened up one's eyes.
• 40:10
  SPEAKER_03: I have two takeaways.
• 40:12
  SPEAKER_03: My first, even because it's more recent within within the conversation, cheap is not better, especially for this patient.
• 40:20
  SPEAKER_03: It's also important until because I can imagine that a lot of a counterfeit exists because there is that despair from patients who might not be able to afford them.
• 40:29
  SPEAKER_03: So please check before getting any drug from any obscure place.
• 40:35
  SPEAKER_03: And even if it's similar, it might not be better, it might even be harmful.
• 40:40
  SPEAKER_03: So take care of yourself, which is a preface segue to my other takeaway, which is the biggest one.
• 40:46
  SPEAKER_03: You are your first love.
• 40:48
  SPEAKER_03: That was so sweet.
• 40:49
  SPEAKER_03: I really love that.
• 40:50
  SPEAKER_01: And I think we should remember that.
• 40:52
  SPEAKER_01: Yes, Dave, if our listeners have follow-up questions or want to get in touch, where can they find you?
• 40:58
  SPEAKER_00: I mean everywhere.
• 40:59
  SPEAKER_00: The great part, I'm on LinkedIn, Facebook, Instagram, and Shemetsky is not a common name.
• 41:06
  SPEAKER_00: So uh so it's it's easy, it's is it's very easy to find me.
• 41:10
  SPEAKER_00: Uh, and you know, it's uh I also have a website, davidshmetzky.com.
• 41:15
  SPEAKER_00: I I I enjoy these type of conversations.
• 41:17
  SPEAKER_00: I love talking about the drug pro drug process, and once we do that, I I know at one point I taught kids in high school about the drug process because if we can learn it then, it's like anything else, learn that foundation, we can then grow that much more and trying to bring a little bit more life into the big pharma.
• 41:37
  SPEAKER_01: Love that.
• 41:38
  SPEAKER_01: Well, Dave, thank you so much for joining us today.
• 41:41
  SPEAKER_01: It's been such a pleasure.
• 41:42
  SPEAKER_00: Thank you for the opportunity.
• 41:43
  SPEAKER_01: Thank you, Dave.
• 41:48
  SPEAKER_01: This was Lab to Live.
• 41:52
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• 41:59
  SPEAKER_01: What is your take on how we get from the lab to making a difference in patients' lives?
• 42:04
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• 42:09
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