Searching Out Low-Quality Medicine | David Light, Valisure

This transcript was generated automatically. Its accuracy may vary.

[00:00:12] Mike Koelzer, Host: Well, hello, David. Hi there. Thanks for joining the business of pharmacy podcast. Great to have you on. Thank you very 

[00:00:17] David Light: much for having me. David 

[00:00:18] Mike Koelzer, Host: tell our listeners who you are and. What's going on hot right now. 

[00:00:25] David Light: My name's David Light. I'm the founder and CEO of an online pharmacy called Val usher. And, uh, we're a very unique pharmacy.

Um, really the first pharmacy online or not, that is attached to an analytical laboratory. So we actually chemically analyze what's in medications and take samples from every single batch of every single medication that comes through our pharmacy. We screen out those that have problems and then. Deliver direct to patients and medications that come, not just with our brand, but also with the certificate of analysis, very much like nutritional information and, uh, you know, the reality.

And certainly what's getting a lot more visibility these days is that over 80% of our medications are manufactured in India and China. Uh, there's starting to be congressional hearings about this, a lot more visibility about these problems. Uh, certainly a lot of pharmacists I'm sure. Very well aware of all the recalls on Valsartan and Losartan and recently rigidity and, uh, with, uh, uh, serious carcinogen problems, uh, due to a variety of issues in the supply chain.

And, uh, our main focus is on vouchers that we actually check where we're actually analyzing what's in those medications and trying to get the highest, possible quality medications to our patients, uh, and to the industry as a whole. So we're starting to work a lot more with hospitals and healthcare systems to plug in our core value and competency of quality assurance in medication.

[00:01:56] Mike Koelzer, Host: I bet the manufacturers never imagined there'd be someone on this side watching. And do you think they knew that? 

[00:02:04] David Light: That's a good question. Um, you know, I think we're, we're all on the same side here. If its manufacturers are producing quality products and everything's great, but, um, you know, I, I think high level, really one of the issues, uh, that that's allowed, all of these problems that come out is that this is a self-reported industry.

Um, you know, just like you've seen all of these, you know, very vividly with the airline industry, uh, you know, the 7 37 max. And, uh, Hey, when things go wrong with that kind of self regulated industry, you have a plane explode and it's extremely visible, but medications, uh, it's harder to see, um, you know, they all kind of look the same, whether they have percentages in them or whether they're not dissolving properly or have the wrong dosage levels.

These are all things that we checked and we found problems with. Um, so again, it's less visible, but the problems have been there a long time and we're currently rejecting over 10% of the batches. No 

[00:03:04] Mike Koelzer, Host: kidding. Wow. When you say a batch pharmacist, can they think of that as a lot number? Would that be a batch 

[00:03:11] David Light: or exactly 

[00:03:12] Mike Koelzer, Host: synonymous.

Okay. I imagine different manufacturers have different sizes. Lots is that like usually a days production, they would name that a lot or would that be like an hour in every lot number or is that just across the 

[00:03:28] David Light: board? So it can vary from manufacturer manufacturing product to product, but generally they're quite large.

So at the manufacturer, um, we'll usually make millions of pills at a time in one lot. And usually the lot is when they're, they're changing over, uh, you know, starting materials that come in in very large quantities, changing over the machinery. Um, so. It tends to be in a very large quantity. And then of course it goes, you know, drugs are going to go through 10, 20 different hands by the time they actually get to the pharmacy.

Um, so the lots could be split up, uh, around 

[00:04:04] Mike Koelzer, Host: the world. Whatever's in the big tank kind of thing. Right? 

[00:04:06] David Light: Exactly. It could take weeks or even longer, um, to, to make that. 

[00:04:12] Mike Koelzer, Host: Wow. If you get medicine in and then later you get the same lot in, let's say a week later, does that have to be tested too? Or you have a way to record that and say, oh, that's lot 1, 2, 3, 4.

Again, we tested that two weeks ago. So we're good. The, 

the 

[00:04:31] David Light: the way that we're functioning in our, in our standard business model is actually being, uh, buying a large lot. Gotcha. So we actually, uh, from a business perspective, actually function very differently than a lot of pharmacies in the sense that we take a lot of inventories we'll buy six months or sometimes even a year's worth of inventory of right.

Um, so that we maintain a large lot 

[00:04:55] Mike Koelzer, Host: and it's always in your sight and you only have to test it once because it's that same lock. Exactly. 

[00:05:00] David Light: And, uh, you know, we, we've developed a lot of our own proprietary analytics, uh, to, uh, reduce the costs and some of the most expensive, uh, uh, areas of analyzing what's inside of a pill.

We also use a lot of industry standards, so things like our cyanogen analysis, we follow FDA protocols. Uh, so we arguably have a really optimized business for, for the lowest cost, but still high precision analysis, but still cost money. Right. So people ask us all the time, well, how do you make any money doing this?

Um, and, uh, the. Biggest bottom line is that we're buying these large lots. We add this analysis cost, but it amortized over a large lot. So it's really pennies or fractions of a penny per pill. Uh, the digital, 

[00:05:45] Mike Koelzer, Host: you're not working like a regular pharmacy where you're test, you're buying two bottles and testing this each 

[00:05:51] David Light: day, kind of exactly.

And it's a destructive test, right? So the pillars are destroyed. 

[00:05:57] Mike Koelzer, Host: So you never, everybody gets like where most people get a 90 day supply. Like you'd have to be sending out like 82 days supplies and things like that. Cause you, you had to use eight of the tablets, you know? 

[00:06:07] David Light: Exactly. And, and, uh, you know, it also underscores the point that obviously we don't test every pill and we'd have no pills.

Yeah. Um, but, uh, yeah, so that's, that's essentially how it works. 

[00:06:20] Mike Koelzer, Host: That's fascinating. All right. Let's, let's back up in your life, David. I know you went to Yale. What was your degree there? And what, when did you start thinking as an eight year old or 10 or 12 or 15 year old that you wanted to go in that direction?

So what was your degree at Yale? 

[00:06:38] David Light: So I studied molecular biology, um, and, uh, I was always very science minded. Um, and I think entrepreneurial as well. Um, you know, back when I was, I think even in middle school, um, started, uh, an eBay business, uh, selling all sorts of scientific trinkets, like neodymium iron boron, magnets, and elemental sodium.

Um, and. Definitely been a science nerd, um, my whole life. And, uh, I was really interested in chemistry, um, and, uh, biology as well when I got into college. And, uh, molecular biology was kind of, uh, the best of both worlds. Um, and, and I think I, uh, I always really liked the, you know, the, the practical application of this kind of science.

So, you know, having a business around it or, or really impacting people's lives, uh, with it, um, you know, Obviously nothing wrong in being an academic or just studying it. But I really wanted to see it have a direct, practical impact on humanity and people. And, uh, after, uh, graduating from Yale, actually, I, I worked primarily in the biotech industry, um, and a lot in, in DNA sequencing, uh, worked at a company called ion torrent where we kind of had this idea that we would sequence DNA and a microchip.

Um, and, uh, we, we spent a fair amount of time and money. Um, Uh, showing that our original concept that was based on an academic paper, uh, was nonsense and it was just noise. Um, but, uh, we had great support and great scientists and then we actually figured it out, uh, and we had some good backup plans and it's now the number two DNA sequencing technology in the world.

Wow. Um, and so, uh, myself and actually one of the other original founders of Val usher, we were the chemistry department and, uh, we invented a new particle that actually enabled, uh, this system to function and, uh, at a commercial level. And so I headed chemistry, R and D uh, it's kind of developed the whole system around it.

We had, uh, you know, invented new manufacturing and, and QA QC systems and everything had to be done from scratch, because it was just so different from anything that was on there and the market, and it worked. 

[00:09:02] Mike Koelzer, Host: Wow. Define particles for me. Is that, is that a combination of more than one different molecule?

[00:09:08] David Light: Yeah. So it's like a really tiny grain of sand. Um, you know, we were making these DNA binding particles that were like a, you know, a micron size, so like the size of a bacteria or so, um, and, um, yeah. Very difficult to work with. Um, but, but they work really well. And, um, as, as all of the systems where we're working and into science have come together and we've launched and we were, you know, the fastest growing, uh, sequencing company out there.

Um, and we were purchased by life technologies and then Thermo Fisher scientific. And I migrated to a director of product management and more of the business side, and really got an amazing experience at that company. Um, and then one day a good friend of mine from Yale, uh, called me up one day and was, was, uh, telling me about all these problems he was having with his anticonvulsant medications.

I mean, essentially refill it every month. And every once in a while, we'd have this month where he just. Terrible and had all of these side effects and relapses sometimes. And he talked to his doctors and his doctors tell them, listen, there's a lot of variability out there and generics are made all over the world and mostly in India and China, and there's just nothing much we can do about it as doctors, nothing much your pharmacist can do.

And it just kinda is what it is. So he obviously didn't like that answer and called me up and we started to look into it from a technology perspective. Uh, you know, when you're a hammer, all the solutions look like nails and figured if we just develop a higher throughput, lower cost, uh, but really high accuracy system, uh, that we could plug into the end of the supply chain.

I think our high level idea was still that we should analyze, you know, in the United States, um, you know, trust, but verify like great that the manufacturers there are analyzing, but you know, when you read books, like, like bottle of lies that came out, uh, this, uh, this year by Katherine Eban, I mean the amount of fraud that can happen in these kinds of self-reported systems, um, is, is massive.

You know, you have companies like Ranbaxy, they're almost entirely. Fraudulent products that they never tested anything. So, um, point is let's actually test here, um, you know, that the FDA does as many inspections as it can, but it's not doing chemical testing. Uh, uh, very rarely. Sure. And so, um, we developed that, so we spent a couple of years of our own time and money and effort.

And, um, we developed a spectroscopy based approach. So it's specifically Ramond spectroscopy, um, that, uh, essentially enabled us to have all the advantages of lasers, which is really fast and easy and cheap to use. Um, but we didn't have the accuracy that we needed, but we developed the accuracy components.

Um, so we can analyze things like dosage in a very high throughput interchangeable way. I of course 

[00:12:01] Mike Koelzer, Host: know exactly what you're talking about, but for the, but for our listeners, Typography, you're talking about shining light through something and then seeing how the light distributes in the computer kind of reads that is that close.

[00:12:16] David Light: That's pretty much it.

Scanning for, or the information that you're getting back is, the light changes depending on the molecular structure of what you're looking at. Um, and that's how you can actually, uh, usually use that to identify molecules, like, is this a malaria medication or is this a sugar pill? Um, and that's generally what these things are used for, but for us to be able to tell, well, is this a, you know, 80 milligrams of a tour of a Staton, or is this actually 72, um, or, or 97, um, that kind of quantitative analysis, uh, wasn't really possible.

And so that's, we, we developed it, we, we filed the patents on it. We got ISO accreditation. So the international organization for standardization accredited and not just our lab, but also the core technology, uh, And, you know, we were very proud of ourselves and, uh, we had started talking to the big players in the industry, uh, you know, pharmacies and distributors and, and, you know, the, the folks that from a biotech background, that's kind of where you go and license and kind of plug these things in.

And everybody would basically tell us the same thing, which was, yeah. You know, we, we, we know there's problems in the system and, uh, you know, it looks like the problems are even getting worse. Um, but it's not our problem. So we got ISO certification, uh, accreditation actually, uh, not just our laboratory, but also the core technology itself.

Uh, Really showing that is very robust. And, uh, we were very proud of ourselves. And then we went and started talking to the industry, you know, the big, big players in the field of pharmacies and distributors. And, uh, you know, everybody kind of told us the same thing when we, when we approached them about adding quality assurance, you know, at the end of the supply chain, which was, uh, Yeah.

You know, we, we know there's problems out there and, and, uh, quality issues certainly seem to be getting worse. Um, but it's not our problem. It's always somebody else's problem. And, uh, you know, it's such a, this is a $2 trillion global supply chain, and there's always somebody else to point the finger at.

Of course, nobody wanted to take any additional responsibility. And, uh, so at that point, and this is now starting into 2018, uh, we decided that online pharmacy seems to be a big up and coming area, of course. And, uh, you know, more recently Amazon bought PillPack and, and, uh, obviously a lot of movement in that space.

And so, uh, we said, Hey, that seems like a very interesting business to get into, but also be this. They actually bring our core value of this quality assurance and medication just directly to the patients. Right. Um, and, and we were hearing, you know, more and more, and especially after we launched, we heard not just from patients, but also from doctors, um, you know, about their patients that complain all the time about.

Uh, having variability issues, not trusting their generics. And then the doctors are worried about adherence and they were basically the ones that taught us that we kind of created this new category of medication, of a validated generic. You had a brand, which, you know, a lot of people can't afford, but trust.

And now there's, you know, generics, which are over 90%, uh, that people can afford. But, you know, I'll more and more not trust right now that you have this, this validated generic, where we've chemical analyzed samples from every single batch comes with these certificates of analysis, you know, very, you wouldn't buy food without nutritional information on it.

Um, but yet your meds come in an orange bottle and say 10 milligrams, and that's all you really know about it. Um, so. So then that's how we got the voucher. And I think the other thing, uh, after launching, not only do we start hearing a lot from doctors, we, we started to hear a lot from, from hospitals, um, from healthcare systems, uh, that are really kind of directly connected to the patients and, uh, you know, concerned about the operations themselves and know having to deal with these huge recalls and, and all of these problems.

And also, obviously being very concerned about the, the patients, um, you know, the fact that you're, you're hearing more and more from, you know, uh, key opinion leaders at the Cleveland clinic that, uh, they're, they're having problems with, you know, medications for heart transplants and, you know, really important things, uh, that, uh, seemed to have a lot of variability and, and.

It doesn't seem like anybody's really doing that much about it. Um, so we were really engaged to, uh, to do something, you know, not just add more visibility, um, but actually offer a solution where we're really all we're doing is trying to help ensure quality, um, by chemically testing and screening out those that, that have issues.

And, uh, you know, it was when we added carcinogen analysis early this year, because of all these Valsartan Losartan. Right. Uh, that, that we started to see real problems there, uh, that weren't being cut. Um, we found a fourth major carcinogen in Valsartan and did an FDA citizen petition earlier, uh, in the summer.

And then we saw all these problems with, with ranitidine and in Zantac and, and all the, the brand or generic products, um, that that's obviously cut. A lot of news is. For our 

[00:17:51] Mike Koelzer, Host: listeners, just a little bit of the history of how things would work in the pharmacy. Now let's say I'm Mrs. Smith would come in and back in the day with insurance, this is going back to the early eighties.

We could tell them, we'd say, well, this drug is for epilepsy or it's for your heartbeat or something. So the brand name is not necessarily better than the generic, but it's probably more consistent. So stay on that and you'll probably get more consistency there. However, as the insurances, then stop covering the brand names.

Now you're going to the generics and then we would tell people, well, at least stay on the same generic company. It might be more potent or less potent than the brand name drug, but at least it's going to be consistent. But now with the. PBMC insurances are really pressing on pricing. Every pharmacy is really forced to buy the hopefully quality, but least expensive drug.

And so now, even if a drug was chemically pure, it's all over the map on even just the percentage of the drug that has to be in the medicine, not to mention all the things that David just said about the carcinogens and every other thing that could be in there two or three years ago, I was really amazed when I looked up about drugs.

And it said, if you have a drug that has so many milligrams, it's allowed to be so many percent below that, of the drug and so many percent above that, of the drug. I was really floored by that range of how even a certified drug the FDA is saying, yeah, if it's, if it's a hundred milligrams, it can be 95 or 107 or something like that.

And that still passes. Can you comment on that? Are you guys looking at actual strength 

[00:19:51] David Light: Then too, if you go into a Home Depot and you buy a plastic six foot table, they'll say on the label there, um, that that's plus or minus 1%. Um, but most drugs are allowed to be plus or minus 10% and present. 

[00:20:08] Mike Koelzer, Host: That's fascinating in a bad way 

[00:20:10] David Light: to me.

And the reality is that you could have, and we've looked at this, you know, you'll have one manufacturer that's low in that range and then you have another manufacturer that's high in the range. Um, so it's really a 20% variability. That's possible if they're falling over. Yeah. And then obviously not everybody follows all the rules.

We've found drugs, even really important, narrow therapy, narrow therapeutic index drugs, like levothyroxine, uh, thyroid medication that's failed, uh, the standard specs and our outside of it. Um, and by the way, once you are also disillusioned, so how the pill dissolves in your body and gets the bloodstream, um, that's allowed to vary 4,500.

Oh my gosh from one manufacturer to the next. So it can be minus 20 to plus 25 in 

[00:21:00] Mike Koelzer, Host: blood levels after disillusion. Wow. And are you finding that the same manufacturer from lot to lot has different percentages or are those usually pretty close? Like let's say it's 92 milligrams instead of a hundred. Is that consistent or are you finding that even from the same manufacturer that maybe the next time it's 103 

[00:21:22] David Light: milligram.

It's really hard to tell. Um, because honestly, uh, so sometimes yeah, you, do you see a manufacturer at least stay relatively the same. Uh, you know, ballpark, then you will see it. Sometimes we also do inactive ingredient scans and we'll see that the sourcing of the material must have entirely changed. Uh, and, and it could be from entirely different factories, right?

The same product could be made in a variety of different places, uh, under the same manufacturer. Um, so really the, to do it, right. It has to be done batch by batch, um, and you know, things that are very straightforward, like carcinogen levels. Um, when we did our deep analysis of Valsartan. And we look not just at the, uh, and DMA, uh, nitro.

So dimethyl amine, which is, uh, been one of the key, big, uh, carcinogen problems, but N DMA, uh, it's largely, uh, theorized, uh, has, uh, in the case of El Sarton was made by the switch to the solvent called DMF. Uh dimethylformamide which itself is a carcinogen and actually a group two carcinogen, the same level of probably carcinogenic to humans, um, that NDA.

And so we said, you know what, let's be proactive and look for that too. And we found it in about two thirds of all of the batches we analyzed. We found this carcinogen, um, including the brand. Wow. Uh, the brand was, was lower, uh, than, than some of the generics that were much higher than that. We analyzed the point that you really gotta check everything.

You know, a brand is not a guarantee of, of absolute quality Zantac as well. We looked at the Zantac, we looked at the generics and we found problems all around. Um, but the point was that when we looked at this deep dive in Valsartan, um, you know, there's so many factors that were totally clean and. And then we tested another batch or even just a combination product of, of, you know, Val Sargent like hydrochlorothiazide.

Uh, and then it failed completely. Like it had really high levels of the dimethylformamide. And even in DMA, we found a batch that was failing even FDA spec on, on, the known and well studied carcinogen. 

[00:23:35] Mike Koelzer, Host: That's fascinating. Let me use the drug strength as the example again, let's say your limit is 10%, but you find it at 8% off.

Do you then? Pass that along to the consumer, or do you just have basically a green light red light kind of thing? Because even as a pharmacist, if you sent something to me and said, this is supposed to be a hundred milligrams, but it's 92 milligrams and it's okay. I would say, wait a minute, you guys didn't do your job, even though you did, because the FDA allows that.

How do you go about that? Are you just saying yes, this is okay. You're not giving it all the. Data. I imagine 

[00:24:26] David Light: we're also, we're not trying to, uh, to scare people or make them uncomfortable with their medications. And, and I think you're, you're you're right. That probably the average American consumers, assuming that when it says a hundred milligrams, it's 100.0, zero, zero milligrams and, and, you know, to be fair, uh, and coming from the sciences and, and, you know, manufacturing of, of biotech device world, um, it's never going to be perfect.

No. Right. Um, and you know, we, we would love for the FDA and the USP to, to get tighter, especially in certain products where we're really obvious that it makes a difference. But, you know, ultimately, uh, we, we are kind of a, it's either red or it's green. Uh, we do try to find many factors that are also more as consistent as we can get.

Um, but we don't make drugs. Right. For sure. Um, so we're beholden to whatever's out there and then obviously we, people need their meds. Um, so, you know, if things are failing, we don't care. We've had situations where we were just unable to find a particular med that was passing. Um, but usually we do.

Um, and, and we make sure that it's, at the very least within the prescribed, you know, United States, pharmacopeia bounds, you know, the monographs, um, or the FDA standards, 

[00:25:50] Mike Koelzer, Host: They might say this drug has allowed us to have so much of not just the chemical strength, but so much. Ax, but no more than X, whether that's the filler or whatever, and you're making sure that it's in those ranges.

Right, 

[00:26:06] David Light: exactly. And like disillusion, um, you know, they, they might say extended release, but when you actually look at, at the, the monographs, you might say between 12 and 15 hours or, um, you know, or, or sometimes even, um, you know, uh, more broad than that, or, you know, we, we follow to make sure that they're at least following that and actually on, on the subject of the pill coming apart.

One thing that we do, you know, as scientists is we make sure to test medications in conditions that are, uh, kind of real world conditions. So actually looking at, at, uh, conditions of what would be in your stomach, uh, what would be in your intestinal fluid, right. And there are industry standards around.

Uh, and, and academic standards, but unfortunately, some of the problems that we see a fair amount in disillusion is that, um, the drug companies themselves are allowed to register whatever rules they want in how to even analyze for a drug, uh, uh, dissolving and, uh, w which is very odd to us. Um, and, and usually they're, they're reasonable tests, but, uh, there are situations like, for example, with Lamotrigine that, that we've done a deeper study on, and there's a number of these drugs that we really delve into, um, where the USB registered monograph for how, you know, for, for essentially the way this works is you have a beaker, um, with solution, um, that, uh, that is similar to your stomach, like, uh, you know, uh, Siddiq pH, or when it goes into intestine.

[00:27:47] Mike Koelzer, Host: Ice cream and he cons and things like that in there too. That's part of the 

[00:27:52] David Light: The reality of doing a lab test is you can't perfectly recreate all the pecans and the hot dogs and those kinds of things. But, you know, at the very least you have the major products in the right pH, uh, And, uh, so usually you start at a pH of 1.2 or two for the stomach, which is a very acidic pH.

And then intestine is usually about a pH of 6.8, um, and you know, reasonable salt concentrations, and you basically have a pill and a paddle in there, and a paddle kind of spins around and you measure samples from this speaker, uh, over time to see how the pill was dissolving and the drug is getting into the solution.

So that's kinda how it works. All the conditions in Deeker can actually be determined by the drug companies who develop the drug. And so you have situations like Lamotrigene, which is really important. Anticonvulsant, antiepileptic drug, also an antidepressant. The solution is supposed to be a pH of 12, while a drain cleaner is a pH of 11.

So this is like super extra strength, drain cleaner pH wise, and there's enough ionic, surfactant, or soap in there to kill. Wow. Um, so, you know, you have this solution, uh, that dissolves the pill very well. It can also dissolve your hands. Um, but it's, uh, at least in our view, not a very good metric for how it would actually dissolve in your body.

Yeah. 

[00:29:19] Mike Koelzer, Host: Right. It's like if a pill had to be whatever crushed somehow or something, and they say, well, we ran over it with a tank. It's like, well, yeah, but we need to, we need it to be chewable or something like that. 

[00:29:30] David Light: Precisely in our laboratory. Um, we follow. Standard, you know, industry standards of, of what a human stomach would be, what a human intestine would be.

Um, and you know, in some of these cases, when we tested in these real world conditions, you get very different results. Um, and we, uh, oftentimes screen out products that way as well. Um, so, you know, they may not have, you know, the red green you talked about, maybe that would have been a green, um, if you would have, you know, essentially tested in drain cleaner.

Um, but when we test it in physiologically relevant and in real-world conditions and, and we get a red, uh, we still screen that out. I was 

[00:30:15] Mike Koelzer, Host: listening to an interview with you. We're on. And in fact, you've got like, what you would say is a hundred point inspection. You're, you're testing a ton of stuff on every medicine, right?

Exactly. 

[00:30:26] David Light: We, we test multiple different carcinogens, um, and you know, different medications have different tests that, that they get, obviously wouldn't make much sense to do disillusion analysis and eye drops. Um, and, uh, we, we, we have a lot of our core products, you know, high volume products that we do really deep analysis on.

Uh, but you know, certain analyses like dosage, like disillusion, uh, really calibrate to the drug itself. Um, and you know, it's a lot of our proprietary technology. We can do these kinds of calibrations in, in a day or two, but still takes a whole day of calibrating just to that drug. So we're slower in adding more and more drugs and we have about a hundred drug products or so that we do the very deep analysis on other analyses, like carcinogens analysis.

Um, we have to calibrate for the carcinogens. So we have about seven carcinogens right now that we analyze for every batch of every medication. Um, but that we don't have to tailor to the actual drug. Gotcha. So we have over 2000 drug products that we can at the very least, you know, have this safety screen of analyzing for those carcinogens.

And that's how we found them. Zantac and 

[00:31:37] Mike Koelzer, Host: carcinogens, I'm imagining there's millions of carcinogens. And if you guys are doing seven, you're doing the ones that somehow seem to sneak their way into manufacturing plants. It's either the metal that a lot of these plants use or some other thing is, is that 

[00:31:56] David Light: correct?

No, you're right. There are at the very least thousands of known carcinogens. Um, and, uh, it would be almost impossible to actually. Uh, analyze for every single possible thing that could go wrong in the medication. Um, and, and, you know, we, we want to be very transparent about that. You know, when you have medication us, it's not an absolute guarantee that every possibility was ever checked a lot more than zero.

Yeah. Um, and, and the, the point is that you can be smart about these things. You can make educated guesses about what to look for, what, what are bigger problems, what are kind of known many factoring problems, um, you know, specifically these nitrosamine Kirsten engine, so N DMA and DEA that you start to hear a lot about the blood pressure meds, uh, the problem with Zantec and was MDMA again, um, these, this class of carcinogen called nitrosamines has been well studied since the 1950s.

Uh, it's one of these. Potent carcinogens on the planet. Um, and, uh, one of the best studied ones there are, and, you know, people sometimes get hung up on the concept that it's, it's described as a probable human carcinogen. Um, and so doesn't that mean that it's not so bad? Um, but the only reason that it's a probable human carcinogen is you can't have a study where you actually give people a carcinogen and then try and see what kind of cancer, right.

Obviously that would not be an ethical study to have. So they do the studies on animals and in the animals, it's extremely clear. Um, you know, it, it, uh, N DMA is actually used as a control to induce cancer in clinical studies on rats. You know, if you want to be sure that a rat is going to get cancer, give it to them.

And so there is N DMA at very low levels in a variety of things. 

[00:33:57] Mike Koelzer, Host: Is that the place where you'll see, like, if something says no nitrates, like on the front of a hot dog thing, our nitrates and DMA, or is that too broad of a brush? 

[00:34:08] David Light: No, that's actually, uh, it touches on a really important point, um, is, uh, uh, nitrates or also nitrites nitrates, which.

Uh, if you look at a hot dog, uh, um, package. Yeah. Um, a lot of them, if you look at the ingredients, you'll see sodium nitrites. And since it's an additive, they put in 

[00:34:31] Mike Koelzer, Host: there flavor and coloring and to make it taste better and longer life and all that 

stuff. 

[00:34:37] David Light: Right. Uh, a really important point related to Zantac and rigidity.

And this has been discussed, um, is that there's actually a. 50 years, five decades of research that are looking at nitrites in your stomach, uh, that react with certain drugs. Um, and, uh, this has been a really big area of, of academic research, uh, in, you know, paper journals, like nature and the Lancet and, you know, really serious, you know, big scientific publications for, for decades.

Um, and actually in 1979, Uh, there was a drug called . That was a histamine blocker and over the counter drug, um, it, uh, had an unstable DMA group, a dimethyl amine group on the, on the molecule itself, uh, that was suspected and through a lot of studies to react with nitrite in your stomach and then form and DMA.

So nitrite is like the end, right? It's the end of the end DMA. And so you could have the DMA on the drug and then if you're eating nitrite, um, Then those two can combine and form a DMA in your stomach. This was the reason, uh, all this carcinogen carcinogen, uh, worries, uh, caused this drug to be recalled.

And that drug that was out for 25 years is over the counter. You know, the FDA, the national cancer Institute and all over the world and industry recalled this drug, um, because of very similar problems of exactly what's happening in, in

which is the active ingredient of Zantac, um, has not just a DMA on the molecule, which can react with nitrate in your stomach. It also has nitrite. It has an N on the molecule as well. Oh, 

[00:36:38] Mike Koelzer, Host: I see. Gotcha. 

[00:36:40] David Light: And, and a lot of the initial data that we looked at that we put in our FDA citizen petition was that, uh, at, at, you know, standard analysis, temperatures, which are higher than body temperature, these are really standard for analysis, uh, in the laboratory.

Um, the drug was actually reacting with itself. Wow. So it was able to, you know, certainly in the stomach is concerning. Uh, but the fact that the molecule is so unstable, that it can react with itself within minutes and form, you know, not just, you know, low levels of , but millions and millions of nanograms, so that the FDA limit for N DMA is 96 nanograms per day.

And we were detecting millions in the detectors, the 

[00:37:30] Mike Koelzer, Host: hotdog itself, they even call some of them hot. Carcinogens, but not because of the nitrites necessarily. Yeah. 

[00:37:39] David Light: So, uh, also important to differentiate that there are, you know, cured meat, uh, even in very low levels in water sometimes, um, you can find N DMA, the carcinogen itself.

So nitrite by itself is not necessarily carcinogenic. Um, but when it combines with the N DMA, uh, sorry, when it combines with the DMA, that's the last time 

[00:38:02] Mike Koelzer, Host: I'm going to correct you. Excuse me. 

[00:38:05] David Light: Sorry. Do I have 

[00:38:06] Mike Koelzer, Host: to do everything around here, David? 

[00:38:10] David Light: All right. Glad you're listening. So, uh, and, and by the way, this is actually a pretty relevant and important, um, you know, getting down into the weeds here because, uh, there's, uh, actually, uh, statements that came from the FDA recently about, uh, analyzing, uh, stomach conditions and, and they claimed that they didn't find any N DMA being formed, uh, with, uh, Dean and Zantac products.

Um, but it seems that they didn't add any nitrites. So they just had acid and salt, you know, uh, the simulated gastric fluid standard, uh, which especially in this case is, is just not a representation of a real world. Stomach. 

[00:38:59] Mike Koelzer, Host: Would you have to add it though? Because if it already has the N there, would you have to add it or when you do add it, it.

[00:39:11] David Light: Um, so certainly when you added it, it was more gotcha. When you have just the free nitrite and that's what we saw as well. I see is that when you're in the, in the very simplistic stomach condition, so you can't just, like you said before, like we, we can't test, uh, with pecans in there and hot dogs and everything else, and we don't know what you're going to eat versus your 

[00:39:30] Mike Koelzer, Host: neighbor.

I tried to learn everything. And so you always have it in the stomach. 

[00:39:34] David Light: And even if you didn't eat anything with nitrite in it, you're going to have nitrite in your stomach. It's always present in your stomach. It's always present in your blood. Nitride is also getting many factored, uh, in your body, by bacteria, in your psoriasis, by bacteria and ironically, um, When you, when you take an antacid, it's often because you've eaten foods particularly high in nitrates, 

[00:39:59] Mike Koelzer, Host: right?

Yeah. You've had your pepperoni pizza and that kind of stuff. Huh. And 

[00:40:03] David Light: dogs and everything else. And it's also very well known in the scientific literature that the act of taking an antacid, uh, dramatically increases the growth of bacteria. That form nitrite, no kidding. Isn't that something like we look, we can, we can argue all day about what is the appropriate amount of nitrite that we should be testing.

Um, you know, our, our, our levels that we used was very similar to a recent clinical study at Stanford university, uh, which is actually also very similar to what the world health organization, um, actually suggested back in their global summit on nitrites nitrates. And nitrosamines in 1978. Um, but you know, we can debate what the right levels are, but they're definitely not.

Yeah, they're absolutely not zero, uh, practically anyone. And, uh, and we did show the test even in our own citizen petition. Um, where if you don't have any nitrites, it's very difficult to detect the end DMA formation. And we didn't detect any, uh, in the stomach conditions. You might still be forming it in the body and you might still be forming it by enzymes that are in your stomach and everything else, which are almost impossible to replicate.

Um, but you have to put some nitrite in there, uh, in order to test them properly, 

[00:41:26] Mike Koelzer, Host: they're creating their own false 

[00:41:28] David Light: condition. Yeah. So at the very least, these are very different conditions than what's been used for 50 years, uh, by academic researchers. Um, so we, we still very much believe that the N DMA carcinogen is being formed in the human stomach at alarmingly high levels, uh, with, uh, Uh, ranitidine.

So whether it's Zantac or any other manufacturer, a generic or, or, and it doesn't matter if it's in a pill or a syrup or any form, um, we think there's a very high danger of this forming high levels of MDMA in your stomach and potentially even higher levels of goes out of your stomach throughout your body.

I mean, you have these enzymes that are these, you know, micro reactors, these chemical reactors throughout your body. Um, you have, you have thousands and thousands of different kinds of these. And when you have a molecule, that's just so inherently unstable, um, that it could even be reacting with itself. Um, let alone anything else in your body 

[00:42:35] Mike Koelzer, Host: reacting right with itself.

Exactly. And 

[00:42:37] David Light: it's not just that it's degrading, it's reacting and then directly forming one of the most potent carcinogens on the planet. 

[00:42:45] Mike Koelzer, Host: We're not just chasing down anything here. I think you said that if you have a rat that you need to get cancer, because you have to study something else, how, whatever the cancer does to them, you're giving NDMA was that.

right 

[00:42:59] David Light: That's correct. It's used in clinical studies to induce cancer in rats 

[00:43:03] Mike Koelzer, Host: It's like, if we want 

that rat to get cancer, we're not going to have him puff on a cigarette. We're not going to have them, you know, eat, eat a bunch of bacon or hotdogs. We're going to give them NDMA to make sure they get cancer or else we're all going to get fired because the rats don't get cancer.

[00:43:21] David Light: And 

you're going to have a weak study because you need a control where you know that the rat's going to get cancer. 

[00:43:29] Mike Koelzer, Host: Theranos certainly that whole story. I don't think that was the subject of the book you mentioned earlier, thermal. Certainly definitely an example of fraud, an example of fraud. How do you get across that?

You guys aren't 

[00:43:44] David Light: Theranos yeah. And, uh, obviously very aware of, of fairness and, and all of the terrible and deceptive things that they did. And I do want to clarify that, you know, the book that I mentioned, bottle of lies by Catherine, even that's about the fraud in the generic drug industry and gotcha.

Um, you know, analytical reports and things like that, uh, kind of similar to therapist's actually, um, point is that, uh, we, we differentiate ourselves in, in many ways from that, um, you know, even our proprietary technology, um, you know, it, wasn't just us saying that it works. We voluntarily brought the international organization for standardization.

You're 

[00:44:27] Mike Koelzer, Host: inviting them to breathe down your neck. 

[00:44:29] David Light: Exactly. Which, which, which is, which is days of audio and going through all the details, not just of the laboratory system, but, but the analysis itself and how robust and consistent it is. Um, and then on top of that, as we add more and more tests to what we do, we also use industry standards.

You know, the tests that we analyzed ranitidine with, uh, was the FDA standard at the time. Um, The standard technology. So gas chromatography, mass spectrometry has been around for decades. Um, and we're also an ISO accredited international organization for standardization on those particular tests as well.

Like us, we really know how to run those. And I think lastly, you know, the fact that, um, what we're doing is getting so much impact and recognition. Um, you know, we we're, we're obviously having some scientific debate with, with the FDA over conditions and, and things like that. But the bottom line is that there's recalls now all over the world and they confirmed that N DMA is there and it shouldn't be, um, and, and again, like, you know, we, we feel that this is a much more serious problem of inherent instability of the drugs.

All lots are affected. Um, and we're still debating that, um, obviously, but look, you have four days after the FDA's statement, you had health Canada come out, um, and, and. Uh, ban ranitidine altogether, right throughout Canada, it was just banned. And they said in the second line of, of their statement, they said, current evidence suggests that ND may, may be present in renewed Dean regardless of the manufacturer, as in it's an inherent problem.

And then about 40 other countries followed, right? So, you know, Germany, France, Italy, uh, Saudi Arabia, you know, Pakistan, Pakistan not only banned ranitidine entirely, uh, they also banned the manufacturing of grenadine in Pakistan. Um, Taiwan instituted fines for any pharmacy. That still has products on their shelves.

You know, Korea, uh, released some of their data and they were finding over 300 times the permissible levels of N DMA, just as a contamination, not even in the, in the body, you know, we're, we're very concerned about even higher levels in the body. Wow. Long story short, um, to answer your question, uh, I think the validity of the science that we do and it's an important, or being born out by, by many organizations, uh, that are, that are serious organizations and regulators now over the world, 

[00:47:06] Mike Koelzer, Host: you're not just going to put on a black turtleneck and lower your voice to show your eye, to show your authority.

Right. 

[00:47:13] David Light: I threw away all the turtle mix. 

[00:47:18] Mike Koelzer, Host: Do you guys come across any just counterfeits? 

[00:47:20] David Light: You know, we do an inactive ingredient scan as well. Where, where we, uh, at least theorized that we might find counterfeits. Cause I mean, a counterfeit could have the right drug in there. Right? We're looking for the drug.

Um, we're looking for, you know, carcinogens, maybe they made it cleanly. Um, but it's very likely that the inactive ingredients, which tend to be proprietary formulations, um, would be done wrong. And so we also scan for the inactive ingredients and we have found actual products where the inactive ingredients were incorrect.

Um, now could that have been a manufacturer mistake? Uh, possibly, uh, Or it could have been a counterfeit. Have 

[00:48:00] Mike Koelzer, Host: you found any, were just the drug itself is not in 

[00:48:03] David Light: there? Um, we, we have found, uh, before where, where the, the drug component was wrong, wrong, just 

[00:48:11] Mike Koelzer, Host: the wrong drug, like maybe a mix, 

[00:48:14] David Light: right? Or like actually, what, what we specifically found was the salts were wrong.

Right? So you might have a drug that's a hydro chloride. Um, and then in reality it was hydrobromide or, you know, you can have a second Nate, like, you know, Metoprolol succinate versus tartrate, you know? And, and so, um, we have found instances where the counterion the salt was. 

[00:48:36] Mike Koelzer, Host: Yeah. And for our listeners, the ones you mentioned have a lot to do with how long it's going to be released in the body.

So if you've got a heart medicine and you think it's going to release over 24 hours, but it releases over two hours, you've got some potential issues there. 

[00:48:53] David Light: Um, and, and those are technically different products, right? The. You know, the, the counter on that, the other half of the drug, um, is, is part of the overall drugs function many times.

Yeah. 

[00:49:05] Mike Koelzer, Host: About five years ago, we actually had a counterfeit drug, one of the pharmacists, well, we never had the drug tested, but one of the pharmacists called me and said, I opened up this bottle of this drug and it was the wrong color tablet and the wrong milligram. We looked at some other sealed bottles and they were actually different in strength.

And my guess is they were counterfeit And the FBI. And so on, got involved. And, um, That was about the last we heard of it, but they're, they're out there, you know? Yeah, 

[00:49:33] David Light: no, absolutely. Um, and, and there's been a lot of attention to counterfeits, uh, in, in, you know, a number of years, uh, now in, in the media and, and, uh, you know, the world health organization is quite concerned about it.

Um, but I think one of the things that we've really been seeing is that just because it's authentic doesn't mean it's good either. Um, you know, these, uh, all, all All the ranitidine tablets are authentically made and, and, you know, made in the right factories. Um, but you know, Hey, sometimes these factories have very serious problems like, uh, the, you know, all of these issues with Valsartan and, and Losartan and Irbesartan are really due to just poor factoring practices.

Um, and, uh, you know, Zantec and renews, and seems to be a totally different problem of the drug itself. But the point is this all boils down to the same need for additional quality assurance here in the United States, independent testing, you know, testing that isn't part of the standard regulatory pharma world, which I'd like to think does as good of a job as it can.

And, and, you know, it's just trying to produce high quality products, but look, everybody makes them. Yeah. Um, and, and there's no doubt that there's also some bad actors there, um, especially with so much manufacturing being overseas, um, that really, we need to be testing here in the United States, independently and chemical testing on every batch is the end DMA 

[00:51:11] Mike Koelzer, Host: that tip of the iceberg for all kinds of stuff, that's going to start coming out or is Renetta Dean like a special focus or this like a cascade of now all kinds of stuff like this.

[00:51:24] David Light: I mean, you, you don't know what you don't know. Um, but, uh, I will say that we're a small company, you know, we, we just launched this thing a year ago and we're just tripping over these problems and, and we, um, w. Finding more issues than we have resources to fully investigate. Um, and you know, we don't release these studies, you know, publicly until we have a lot of the data. You know, we know the impact and we don't want to scare people for no reason.

Um, and we, we want to make sure that the science has done absolutely, you know, uh, that we have super high confidence in what we released. Um, and, you know, repeat the studies, have external folks repeat them and that kind of thing. Um, but, uh, I can definitely say that, uh, it's a lot of issues out there, uh, some bigger than others.

And, um, I, I would predict that, uh, this is not the last that we were. Okay. 

[00:52:26] Mike Koelzer, Host: The last we're going to see. All right, David, here is the big question that's been building up inside of. Through the interview here, there's this problem out there and you guys have found a great solution for it. Other people can do things like put the medicine in a bottle and put stamps on the packages and things like that.

I'd imagine at some point, and I'm sure a million times it's been through your head, that your company becomes the good housekeeping seal of approval. And you're making money on that through all the pharmacies who everybody says, well, I'm not going to use that if there's not the valleys. Sure. Seal of approval on it.

When do you? Or do you, at some point switch that where your, the, your, the approval of the world is looking for versus a drug from you going somewhere? 

[00:53:27] David Light: Excellent question. And I think the, uh, you know, high level, what we're really interested in and what we're really good at, uh, is that quality assurance and, uh, plugging that into other pharmacies, to other healthcare systems.

Um, uh, and that could be through a variety of different ways. You know, maybe that's, you know, wholesale and a few key drugs for now, or, or, you know, a lot of hospitals have talked to us about, you know, access to the data, um, you know, the, all the data and what we're rejecting and why. Yeah, because 

[00:54:05] Mike Koelzer, Host: They might say, well, you know, this rejects so many percent of the time, Hey, let's just stay away from it.

We can buy it from company A why, why go with B that David. Found a problem a lot of the time. 

[00:54:15] David Light: Right. And they don't want that on their shelves either. Right? Yeah. Um, and so, you know, we're, we're working with a number of, of new partners and experts in these fields, um, you know, data scientists and you know, how, how can we get, uh, uh, as much as possible, the core value of what we do to, to plug into others and, you know, Um, you know, what you described might really be possible is to plug this into manufacturers and distributors and just really have this done consistently.

Um, uh, but until we get there and there's a lot of hurdles to doing that. Right. And I think, and I think part of the difficulty here is that we're finding that you really have to do this batch by batch. Now maybe we can aggregate some of the data, um, and get a good feel for areas to avoid or to improve batch by batch should really need to be batch by batch.

Um, so, you know, we still feel that our primary pharmacy component is really important for what we do in general. Uh, however, at the same time getting as much of that value as we can to others and, you know, perhaps through a few key drugs or perhaps through. Um, where we may add some quality scores, you know, that the FDA has actually made an announcement where they want to have, um, uh, scores, different scores for different manufacturers based on, uh, their quality system maturity.

Um, so essentially how much paperwork they've done. Um, and, and how long they've been part of these quality management systems. We're not interested in, um, uh, a lot of paperwork just for the sake of paperwork. Now, we think that you have to chemically analyze it. 

[00:56:04] Mike Koelzer, Host: People can have a stack of paper, but if it's not looking for the right stuff, or like, we talked about the other company, if it's not using the right landscape of what your body really is, the right condition, the right condition.

If it's not testing that, it's not really passing it 

[00:56:19] David Light: then. Right. Exactly. So I think we can start aggregating this into quality scores and, you know, things like that. Um, and we're very interested in working with hospitals with healthcare systems. Yeah. 

[00:56:32] Mike Koelzer, Host: Kind of a consumer reports kind of thing almost. 

[00:56:34] David Light: Right.

Right. So I think that there's many ways that we can start to really infuse the grander value of the quality assurance, uh, that we do, um, uh, in, into the system to touch more patients and, and get closer to this grand vision of everything being tested independently. 

[00:56:55] Mike Koelzer, Host: Yeah. If I may be my own devil's advocate to my devil's advocate, I would imagine too, that part of the value you guys have is once you've captured a lot, you've tested it.

You have your eyes on it. Now. It hasn't gone. To another, all sailors who could switch something or have it on a shelf too long, you know, whatever. I mean, it's like when you test something, when you give it your approval, the next step is the customer. It's not another eight steps going through possible fraud things and all that kind of stuff.

That's number one. And number two is I guess that one thing you can prove through all, this is your proof of concept, I guess, of what the desire or demand is for your prescription. Right? 

[00:57:40] David Light: And you, your, your first point there touches on, uh, I think, uh, uh, an expert that when we were first starting to talk about this a hundred point inspection concept, um, there's a lot of parallels between the medication you're going to pick up at a pharmacy to a UC.

Right. I mean, the reality is that it's, it's touched 10, 20 different hands. It's got thousands of miles on it. It's been all over the world. It's probably a few years old. Uh, and so really you're buying a used car, but then 

[00:58:12] Mike Koelzer, Host: They say just granny had it in her garage for 15 years. Right. I, 

[00:58:16] David Light: if you're buying a used car, you're not going to be like, oh, well, you know, Volkswagen tested it in the plant somewhere.

Right? You want to have your point inspection on that car that you're going to be buying. And that really speaks to your point of, if you have to test it before the consumer is going to get it or shortly before. And of this whole supply chain, um, which, which is not an easy thing to do. And, uh, obviously adds a lot of the stress on the pharmacy.

You know, we have a lot of work that we do in our own pharmacy. Imagine, you know, the bottom line is that, uh, we are working towards systems and efficiencies too, to plug this in and to make it as easy as possible for other pharmacists or other healthcare practitioners, to be able to use this. 

[00:59:07] Mike Koelzer, Host: Yeah, but like you say, with the car analogy, that's absolutely right.

Because if you were to test it, not until the end, then it's like testing a car out, but then giving it to a teenager did drive around for two years and I never, never put oil in it and have the engine burnout. I'm not, not that I'm angry at my kids for any of that. Never happened. Never happened, but yeah, you, you got to be close to that end product or else your value has lost its approval.

If you have other hands touching it in the, in the final process of things. 

[00:59:42] David Light: Exactly. And, uh, and that's why it has to be really towards the end of the chain. Um, you know, at the, at the buy time, uh, for that, for that patient, for that customer, uh, and, and batch to batch, you know, it's just because you know, this one model of car worked out well for you doesn't mean.

Everything else that that manufacturer's ever made is perfect. 

[01:00:08] Mike Koelzer, Host: Yeah. Oh, I thought of another way to be a devil's advocate. Perfect. All right, here we go. You guys mail orders to people you hear about. It's in the heat of the postal truck for the day or it's 23 degrees in the mailbox for two hours before the customer gets it.

Do you guys have anything like that to refute those claims that a typical brick and mortar pharmacy would use against mail order? 

[01:00:37] David Light: It is an important point and we are aware and, and concerned about it. And I think one of them. Uh, important differentiations and also what we decide to ship or not is we don't do cold chain shipping.

So you have drugs that are classified as being unstable or as needing very tight tolerances, um, or, you know, these very specific temperatures, uh, we don't have on our, on our formulary. Um, and, and honestly, you know, some of these drugs, like that we're not classified that way, but, you know, we discovered were very unstable heat 

[01:01:16] Mike Koelzer, Host: or cold produced.

Some of those 

[01:01:17] David Light: exactly, you know, a hot car could have very easily led to, you know, renewing and reacting with itself. I never used those 

[01:01:24] Mike Koelzer, Host: excuses. I didn't know if I believed them or if it was just brick and mortar pharmacies using it as a way to try to scare people a little bit. But I guess, like you say, sometimes the heat, you know, Can do some things to that.

[01:01:36] David Light: Right. And look, there is, you know, as obviously, you know, in, in pharmacy, there is a differentiation between drugs. You have to keep it in a fridge, um, versus one that could sit on the shelf. Um, and, uh, these shipping companies are supposed to adhere to, uh, their own standards as well. Um, so, you know, we, we, we are definitely aware of it and that's a big reason why we don't do some of these really sensitive drugs through mail order.

Um, but, uh, we not only do. Obviously the standard shipping that any other mail order pharmacy does, but, uh, unlike any other pharmacies that we actually are doing kind of inadvertently some of the stability testing, um, uh, through carcinogen analysis and others, um, and, and certainly at least once have, have found a serious concern.

Um, you know, they're an entity inside. Yeah. David, 

[01:02:35] Mike Koelzer, Host: If someone said to you that you're no longer allowed to do drugs, you can't take this road anymore. Are there any holes in the marketplace that can use testing like this in your mind? Like, as someone said, no more drugs that we can't do that. What other areas could your business do if it, if it had, yeah, 

[01:02:52] David Light: Certainly, um, you know, we get asked a lot, um, about, about supplements and we also, we do supplements in our pharmacies as well.

Um, we, we get asked. Um, about CBD and marijuana. I think this whole area has a really big hole in, in regulation over it for a lot of reasons. And you have, you know, various states doing different things. And obviously the federal government is still very much against most of that field. Um, so at Val usher, we, uh, we take playing very seriously playing, you know, very much outside of any gray areas.

You know, we dot our I's and cross our T's and everything we do, you know, legally, uh, And so we have DEA licenses, you know, so we, we, uh, um, we don't participate in that field now, you know, eventually one day, hopefully it'll, it'll be, uh, legalized and then we can get into that. But I think even beyond that, you know, there's a report recently about heavy metals in, in baby food.

Interesting. 

[01:04:00] Mike Koelzer, Host: Right. Food. 

[01:04:01] David Light: Yeah. Baby products in general. Um, there's just a lot of concern over heavy metals and the plastics BPA in plastics. It's something 

[01:04:09] Mike Koelzer, Host: that kids might be munching on or in, in contact with or something like that. So not even internal stuff, right? 

[01:04:16] David Light: Yeah, exactly. You know, Hey, I got four kids, um, and they, they go through a lot of toys and, uh, I don't know.

From, and I, I dunno how well they were made. Um, and we go through a lot of baby food and formula those kinds of things. I definitely think there's a lot of areas for expansion of the core value of independent analysis at the end of the supply chain. That's 

[01:04:40] Mike Koelzer, Host: right. What's your least favorite part of your day in your last couple of years?

Like what day do you wake up and say, crap, it's Wednesday. I gotta do this this week. Something you don't like, 

[01:04:50] David Light: um, you know, being so steeped in the healthcare system now, I was an outsider, right? We were biotech scientists, uh, even in the business of sciences, very different from, uh, you know, the ins and outs of healthcare.

Right. I have to admit the, uh, the complexity in. Convoluted nature of this system is something that I definitely do not like the financial part 

[01:05:15] Mike Koelzer, Host: or the FDA 

drugs. 

[01:05:18] David Light: Um, no, I'd say the, um, the, the nuances of getting a patient, a prescription going through PBM.

[01:05:28] Mike Koelzer, Host: He just made me want to go have a bowl of ice cream now. And so 

[01:05:31] David Light: with some pecans, Um, but yeah, no, seriously. I had no idea what a PBM was before getting into this business and, you know, the fact that they exist and that there are these massive multi-billion dollar organizations that, you know, we as a pharmacy have to contract with, but then are directly competing against at the same time.

Like, I don't even understand how that's legal. Well, 

[01:05:56] Mike Koelzer, Host: David, that's why I said I was devil's advocate. I was actually a friend. I was trying to say, leave, go. You know what I mean? 

[01:06:04] David Light: It's thanks. It's tough. It is tough. But you know what? I think that's also where there's tremendous opportunity. Absolutely.

And it's, it's a system that, you know, when you, especially when you talk to professionals, but even more and more now, just individual average patients, everybody agrees. Healthcare is broken. You're bringing 

[01:06:21] Mike Koelzer, Host: trust into an industry. Inherently, nobody trusts anybody anymore. You found that whole, I 

[01:06:29] David Light: didn't even realize that, right?

Yeah. You haven't even, you didn't even realize. And I think you're right. Is, is one of our core values of transparency, um, and you know, quality through the transparency of what we do. Um, we knew that it was needed, um, you know, when starting the voucher, but we definitely, I don't think we, fully grasp just how needed it is, uh, how difficult it would be to really infuse it into the system.

How many, how many barriers there are, uh, to really innovating and changing the system? There is a growing wave of momentum here that the system needs to change in a lot of ways, right? Like obviously quality assurance and medications, what we're focused on, but there's been a lot of talk about PBMs and all the problems there about drug pricing in general, about drug reimportation from other countries.

Uh, I think there's all sorts of potential solutions and all sorts of issues that need to be tackled. Um, and, uh, and it's hard. All of them are hard, 

[01:07:34] Mike Koelzer, Host: but you're onto that with trust and transparency. I think 

[01:07:37] David Light: so. I absolutely agree. And I think, especially in, you know, first and foremost is safety, right?

Safety and quality of your medications, which are so critical to your health and, and look, the, the, the whole pharmaceutical industries doubled the human lifespan. Like this has been an amazing thing. Yeah. Um, which is great, uh, we just have to make them right. Yeah. Right. Um, and, and, and really kind of fulfill what the generic industry use, or it was originally supposed to be was a, an equivalent, you know, lower costs, um, you know, quality way to, to get all the benefits of, of the original discoveries.

[01:08:17] Mike Koelzer, Host: Yeah. Yeah. But it's human nature. There's always going to be either some purposely nefarious things going on and some of it just cutting corners and cutting them too far. 

[01:08:27] David Light: Right. And I think, look, there's many layers to that problem. There's the problem that these, uh, you know, uh, bad actors out there and in a fair number of them, uh, the fact that the system itself was engineered in a way that it's easy to cheat.

Um, you know, if it was a system that didn't enable so many cracks, we would most likely have fewer of them. Um, so. Kind of institutionally that should change. Right. Um, you know, things like this disillusion that you could use drain cleaner, like why is that? That doesn't make any sense. It makes sense. Um, and that, that takes some fundamental change.

And I think first and foremost, it takes, uh, you know, the humility to say that there are problems. Yeah. I like this, the system isn't perfect. No, um, you know, I think, you know, regulators and industry as a whole are, uh, working towards the best possible products and systems, um, you know, uh, on average and, and that's great, but it's not perfect.

It's far from it. And we have to admit that there are these problems and now let's start fixing it and working with industry with independent, uh, testing and, and, and you know, that ability to have real transparency and real quality assurance, um, and, uh, infuse that to patients is like, I can't imagine anything more important than that.

Yeah. Pricing is important and there's all sorts of important things and you know what PBMs do and, and, you know, uh, restricting choice and all these kinds of things and clawbacks, and a lot of problems out there, but safety, first safety, safety, first quality of your healthcare, and nothing more 

[01:10:10] Mike Koelzer, Host: more important than that.

Yeah. I liked what you said there. Uh, you said that the legislatures are, our regulators are moving forward and, and want the best for people on average. I think you said that was that right? So you got some, you got some bad eggs in there, but on average, it's in the right direction. 

[01:10:28] David Light: Yeah. And, and looking, especially when we read a book, like a bottle of lies and you get into a lot of the details of the really bad actors.

Um, and, but on average, so not everybody's, everybody's like that. But some 

[01:10:42] Mike Koelzer, Host: David 's favorite part of your week. Uh, business-wise I'm 

[01:10:48] David Light: hearing from the patients that we affect, um, you know, more and more, you know, hearing from patients from doctors, you know, thank you for creating this company. Um, you know, H how can I help?

Um, and, and, you know, also yeah, exactly seeing that feedback, like, you know, Hey, I was, I was on this drug for a long time and had all these problems, and now everything is more consistent with my, uh, with my symptoms and just really happy that you guys exist. And I'm very happy that somebody is actually checking.

Um, and, uh, it's, it's very rewarding to get that. And, you know, for me, you know, that's the. Back to your original question of, you know, what excited me as a kid was, you know, sciences and, and all that. But entrepreneurship, in addition to science where you can actually take these really cool, neat things like I love laboratories and, and, uh, you know, spectrometry and, uh, solving scientific problems, is awesome.

Um, but being able to impact people's lives, uh, and improve them and, and, uh, you know, make a difference, um, is very, uh, 

[01:12:05] Mike Koelzer, Host: Yeah, that's so cool. So many of us kids, you know, learn, especially the chemistry and stuff in the, in the books. And you'd see some experiments, you know, and mix vinegar and baking soda and those kinds of things.

But it's cool to really, I'm sure it's really cool for you to be able to see things happen. And then, and then also, like you say, in people, David, finally, what would you do if somebody came in right now and said you got to leave for three months and no, no science, you can't do any science. You can't do anything with the business.

You're kind of like on a three month sabbatical, how would you spend that? Time, basically, 

[01:12:41] David Light: I definitely catch up on surfing and San Diego 

[01:12:45] Mike Koelzer, Host: surfing and San Diego. 

[01:12:47] David Light: Yeah. Yep. Take the whole family down. I grew up in San Diego. Uh, where are you now? Uh, Yale science park in New Haven. Connecticut is where the voucher is.

And I live in the area. Is that 

[01:12:59] Mike Koelzer, Host: due mainly to your schooling or, or is there a reason to be out there in this kind of a molecule. 

[01:13:07] David Light: Yeah. I came out here for school and, um, you know, there's just a tremendous amount of biotech opportunities here. And then working here and kind of grew the roots. And, uh, my wife is a native of the area and, and all her siblings and you know how it goes with.

Yeah, it's a great place, but San Diego is hard to compete with. Yeah, you'd 

[01:13:32] Mike Koelzer, Host: go surfing in San Diego. Yeah. I 

[01:13:35] David Light: used to surf a lot. I'm obviously not very good at surfing in the long island sound. Um, so I do a lot of kayaking out here. It's a surf 

[01:13:45] Mike Koelzer, Host: bigger on the west coast versus east coast. I think that's across the board pretty much.

Right. Well, so 

[01:13:52] David Light: it really depends on just where you are on the east coast. There are some surf spots that are okay. I mean, Connecticut got long island in front of it, so there's really almost no surf 

[01:14:00] Mike Koelzer, Host: gotcha. Down south or 

[01:14:02] David Light: they're surfing and the Pacific is pretty good and there's particularly good beaches in San Diego.

Um, and, uh, yeah, and I was, uh, Actually I was born in Israel. Um, and we worked when we were three, uh, when I was three, uh, to San Diego. Were your parents, did they 

[01:14:17] Mike Koelzer, Host: start as us citizens or are they from Israel and they 

[01:14:20] David Light: became citizens. Yeah. So they're Israeli citizens and then they became citizens in the United States.

It's not like 

[01:14:24] Mike Koelzer, Host: they were there for the, for the service or anything. They were actually from Israel, originally 

[01:14:29] David Light: born and raised in Israel. Uh, and yeah, came, came here and, uh, when I was three years old and, um, uh, the point is that I was, uh, my original name, um, when I was born was yum, which means ocean. Um, and so I've always been strong.

Connection on many levels to, to the water and the ocean. And then I was a very avid surfer when I was in San Diego and a kayaker. And, you know, I still live very close to the beach in Connecticut and, uh, do a lot of kayaking and swimming and those kinds of things, 

[01:15:04] Mike Koelzer, Host: the waves, big enough in San Diego. Are you guys, are you always thinking, I wish I was in, you know, Hawaii or something, or are you satisfied with the waves in San 

[01:15:16] David Light: Diego?

Perfectly satisfied with San Diego? They don't have to 

[01:15:20] Mike Koelzer, Host: Sometimes they're too big for you. Uh, 

[01:15:22] David Light: I enjoy the, you would get a storm out there and we would go and storms here and there, and then you get some pretty big waves. Um, but I, I walk, I'm not a professional surfer by any means. Um, so perfectly happy with San Diego.

[01:15:36] Mike Koelzer, Host: I always pictured myself as, you know, like in lake Michigan, and I'd be right in these ways, like on my tummy board or something like that. And, uh, I would always think it looks so cool, but if someone took a picture of me. Like when I play football with my brothers, we have our annual Turkey bowl coming up in a couple of days and I might like jump for a pass and I'm picturing myself like, looking like I'm in a fallout spread, like the pros and I, I'm probably a half inch off the ground, but in my mind, in my mind I'm doing that.

So that's how I pictured myself surfing, but you've got some real waves out there. That'd be really 

[01:16:12] David Light: cool. That's a lot of fun. It's a great place. Wait, so do you get out 

[01:16:16] Mike Koelzer, Host: there and do that occasionally 

[01:16:17] David Light: then? Uh, here and there. Yeah. When I can find an excuse to get out there, um, you know, when there's a conference out in San Diego that tends to get high priority on my calendar.

Yeah. 

[01:16:27] Mike Koelzer, Host: And my son now who's like 16 is one of my sons, but he was like seven he's in the backseat of the car. And he said, dad, when you die, can you go anywhere? And I'm like, yeah. He's like anyone. I'm like, yeah. And I'm picturing like, he's on this, you know, moon beam going to Saturn or something like that. He says, he says, all right, I'm going to Florida.

[01:16:55] David Light: Yeah. They got these planes these days. So San Diego, San 

[01:17:00] Mike Koelzer, Host: Diego is pretty close to that, but, uh, all right, David, pleasure to meet you. I'll be watching 

[01:17:04] David Light: closely. Thank you. And thank you very much 

[01:17:06] Mike Koelzer, Host: for having me. I was sitting, sitting around and I saw this on, um, my phone going through LinkedIn and I sent off an email to you right away, because it was really something that grabbed my attention.

And I think it's going to grab everybody's attention strongly. You guys are going to do great 

[01:17:20] David Light: things. No, thank you very much. And, and totally agreed. You know, these are real problems that we're addressing. And I think in a very serious way, and we're very interested in interacting with the pharmacy community.

Um, you know, the healthcare systems as a whole cause. So important for, for patients, right? Uh, that, that, we're, that's our, all of our focus in healthcare. Um, so yeah. Now thanks again for the opportunity to go into the story and, uh, yeah. Great, great. To continue these kinds of conversations. My pleasure.

[01:17:54] Mike Koelzer, Host: Yeah. I look forward to keeping in touch. Absolutely. Thanks again. All right. Thanks David. Take care.