1053: Generic Drugs | Skeptical Sunday

22:23You can also search for the sponsors using the AI chatbot on the website as well. Please consider supporting those who support the show. Now, back to Skeptical Sunday. So they have their period of exclusivity with the patent, and then what happens? Free for all? Yeah, pretty much. So the period of exclusivity expires, and then anybody can sell the drug. But they cannot use the trademarked brand name of the original company. And so what happens is that company is hoping that they've established this brand, right? And they had been dominating the marketplace because it was the only option. So they're hoping to continue to dominate the marketplace because there's now recognizability, that brand name associated with that drug.

23:04But other companies can make the drug, and they can sell it as the generic form for whatever price they can set, whatever price they want. If it's a really popular drug, like a headache medicine, like an ibuprofen or an aspirin, it seems like then other companies make the same thing and try their hand at branding it really strongly too, right? Advil, Motrin, Tylenol, there's a million of those. Yes, yeah, definitely. For such common drugs, that is the case. Yeah, definitely. Yeah. Okay. Once again, the drug is identical. They just can't use the brand name. So if they've come out with, and it's funny because I can only think of like terrible drugs that have killed a crap load of people like Vioxx.

23:39So these are terrible examples because nobody's going to want that brand name ever. But let's just say generic. Right. Somebody goes, oh, yeah, we want to copy that, but we can't call it Vioxx. We're just going to call it whatever the either the shorthand name is or they make up another name like Oxvi. And it's like, that's the new version of that. You could. Yeah. Most just go with the generic just because. So like the point here, there's an opportunity to save a lot of money, right, because they don't have to do any research and development. The first company did all of the research and development.

24:09So if you're going to make the generic for a drug that's already been approved for the market, first of all, you don't have to spend money on clinical trials. This was already researched, tested, approved by the FDA. So you just make the drug and then you sell it under the generic name. So for this reason, they can sell it much, much cheaper. So just right off the bat, they don't have to invest in all the stuff so they can sell it cheaper because they haven't invested all that money. Second, what happens a lot of the time is that another pharmaceutical company will figure out how to innovate the synthetic pathway.

24:37So there's a synthetic pathway to the drug. And if somebody figures out a trick and they can make it in fewer steps, or they can cut out a really expensive reagent, or they can just do it in a better, faster, cheaper way, or however they just do it a better way, that cuts down costs even more. And so then they can sell it even cheaper. So however they're doing it, they're just trying to figure out how to make it for less money than the first company. And then whenever you get there, you're like, okay, I have my drug. It's the same drug. All you have to do is you have to show your data. I mean, you do have to prove this to the FDA.

25:08You have to show all your data confirming that everything is chemically equivalent to what's already on the market. And if it's chemically equivalent, then all the existing specifications are met. It's the same thing. So you're ready to sell. Right. So it's not like anyone can just put anything in a bottle and label it as the generic. There's a bunch of hoops to jump through. And you have to say, this is not just a cola that's like Coca-Cola. We took 100 % of the ingredients and they're in here, except the label is white now and it's called Cola, the end. It's very stringent, right? There are regulatory bodies to ensure that what other people are making is just as safe and just as effective as the drug that went through all the rigorous testing.

25:47Okay, but at any rate, the fact remains, once the patent expires, the first companies, I mean, I don't want to say screwed because hopefully they've made a bunch of money in the past to make up their investment at least over the time. but is that sort of it? They just don't have any way to extend anything? To an extent. So, I mean, first of all, just as much as we need patents to be there, we also need them to eventually expire. We want to change to an open marketplace because we don't want monopolies, right? We don't want a company owning exclusive rights to a drug indefinitely. So once the patent expires, they enter a competitive marketplace.

26:21And so this is the good part about capitalism, right? This is where it's a competitive marketplace, so you're going to get a fair market price according to the rules of economics. If you have a bunch of companies making a product, the price points are going to equilibrate at the ideal price that is going to drive the most sales while still making a profit for the company. So it's going to settle on something that it's going to be affordable, basically. And there's no way around that limitation? Are there little like shady loopholes where they're like, ah, we twisted this upside down and now it's the carbon molecules.

26:53I don't know anything about chemistry, but like the carbon molecules on the other side now. So there are kind of little tricky ways that the company, they can try to extend the period of exclusivity. So you have to change something about the drug. You can reformulate the drug in some way. And sometimes it's a really trivial way. That's the way that it's like maybe a little bit shady. You just make it a little bit different. Or like, so for example, sometimes you can have a drug that's a racemate. It's in a racemic form, which means it's two mirror images. It's the same molecule structurally, but you have the two mirror images of it.

27:25So that's the racemic form. But then they're like, no way, actually, we figured out that the enantiopure version, this one enantiomer, the R, not the S, you know, one of the two pairs is better. So we're going to make just this one, and now we're going to sell it like this. They'll substantiate it some way. We did this study. There's just slightly better bioavailability or, you know, whatever. Something is a little bit better. And then if they can convince them, all right, well, this is a little bit better, so we're going to get more time for exclusive sale. Okay, I didn't totally understand all that, and I think a lot of people didn't, but the point is that they can change things.

27:58Some of them are trivial, and some of them are, hey, this is 1 % more bioavailable, and if they buy that argument, they being what, the FDA or the patent office or whatever buys that argument, then they say, fine, you can extend it? Or is it that the other version that isn't that mirror image is now free, but the new slash better one is a new drug? Yeah, I guess I believe what it would be is that the patent would be extended to the Enantiopure, whereas the Racemade at some point then would become generic. What is Enantiopure? What does that mean? So if you have the two mirror images, two Enantiomers are mirror images of one another.

28:31So the Enantiopure is just one of them alone. I see. Without the other one. Oh, okay. One mirror image. Got it, got it. We're talking about molecules like you would draw on paper, for those of you who have no clue what we're talking about. At least that's what I think we're talking about, right? Yes, we're talking about drugs or molecules, right? Yeah. And so they have three-dimensional shape. And so a lot of times when you synthesize molecules, if you're forming something that's chiral, meaning it has a mirror image, so structurally all the bonds are the same, but they're just like your hands are mirror images of each other, right?

29:00But they have the same fingers in the same places, right? So let's say one of your hands is better. So in the pill, in the bottle, you don't want both hands. You want just the right hands or whatever. Left hands only. Yeah, exactly. Yeah. So that's a pretty good way of explaining it because I'm envisioning those little wooden sticks with the balls on the end of it that you see. That's right. On sitcoms or in high school where you're building a molecule. And yes, if you held one up to a mirror, you have the exact opposite thing on the other side. So structurally identical, the same atoms of the same elements bonded to each other in the same way.

29:31Just their mirror images. Perfect. Okay. So if they create new versions of that by mirroring it, whatever, is that abused from time to time? Because it seems like if there's decent money to be made by doing it, big companies are just chomping at the bit to try to do something like that. Yeah. It's a gray area. You could make the argument. I mean, it doesn't violate laws, so it's not really abuse, but it's just that sometimes these changes are so trivial that they don't really represent anything significant for the consumer, but then it may still prevent competition for a few more years. So even once that's elapsed, if they still have the exclusivity on the Enantio Pure, they might encourage doctors to tell patients, hey, listen, you want to tell the patients this version is slightly better.

30:14Here's the data, right? Here's the data. It's 1 % more, like a tiny little bit. So the patient should get this drug. This is the better one. And it's not wrong. Like, that's the thing. It's not incorrect. But it's just that it's a difference that it's nearly negligible or completely negligible. But the other version where the patent expired could still be made into generic form, yeah? Yeah, there are cases where there are alterations that extend the existing patent, but there are, I believe, instances where, as we were saying, it is considered a separate product with a separate patent. Right, okay, yeah.

30:47Yeah. So we're talking about inantio-pure versus racemic, so the two mirror images or just the one version. So again, yeah, I think that you can have the patented inantio-pure and then you have the generic racemate, so both of the two mirror images. and that's whether or not there is any therapeutic difference. So that's kind of where it's tricky, where it's like, does it really matter? This is my lawyer brain just making this point extra annoying, and I apologize to everybody for that. I'm going to stop now. But it's a good point because this is an example of where, like, I push back so much on where people claim unethical behavior in this industry because it's just completely fabricated.

31:22So when we get to a gray area like this, I'm happy to elucidate where it is honestly not, it's really, you couldn't really call it unethical. It's just something where they're kind of playing with the rules a little bit to try to extend exclusivity. They're just sort of, you know what I mean? Like, it's definitely not illegal. It's definitely not wrong or specifically unethical because it's not like it's a worse product. In fact, oftentimes it is a slightly better product, right? You get better absorption, you know, but it's just so negligible to retain the bias in the marketplace for almost no reason is pretty much what we're talking about.

31:58That definitely makes sense. It sounds like, and with the marketing stuff we were talking about before, it sounds like eventually we get to a situation like with ibuprofen or something, where you see it at the store hundreds or even thousands of times throughout your life. We all sort of know it's the same thing as one of those brands, Motrin or something. But maybe not everyone knows that. So they go for the brand they like, or the one they recognize, or they're freaking tired, and they don't want to examine labels and read the back. And they're just like, screw it. I got a headache. Give me this stuff.

32:26Yeah. And first of all, not everybody knows that. Not everybody knows that these brand names are the same as the generic. I mean, I would go so far as to say most people don't know that. But beyond that, look, brand loyalty, there's nothing wrong with brand loyalty if you like Motrin better than the generic. I mean, we're all receptive to advertising, right? You could have a favorite kind of laundry detergent or a favorite kind of butter, right? I get Land O 'Lakes. I don't know why I get, I don't even know if it tastes better. I just like the packaging. You know what I mean? You know, it could be a better product or we're just reflecting the marketing campaign that influenced us the most.

33:02This is not nefarious illegality, right? It's a normal aspect of capitalism. Talking about molecules and butter, it reminds me of, do you remember, I don't know if you've had this, I remember learning margarine is only one molecule away from plastic and everyone was horrified. and then you realize that that's like something super toxic like carbon monoxide being one molecule it's like not even one molecule it's like one atom away from being carbon dioxide and it's like harmless well mostly harmless in small doses and so you're like oh wait a whole molecule away from being plastic that means it's literally just two different substances entirely and you don't have to worry about that yeah people don't know how like it's like people saying that oh, these synthetic drugs are made from coal tar.

33:46Coal is carbon. It's an allotrope of carbon, and these drugs have carbon in them. They're organic molecules, so they have carbon in them. So it's just like people try to act like atoms of a particular element being in a molecule means it behaves like that molecule in its elemental form. Like people flipping out about thimerosal because there's a mercury atom in it, so it must be like elemental mercury. It's just not how chemistry works. That's a whole different show right there with the whole thing like you're injecting a fetus or whatever. Like I hear that all the time. Well, that's even yet a different thing.

34:18No, that's just nonsense. Yeah, that's a whole, I don't want to set you off on that one. All right, so there's also the placebo effect of some of these medications. We've done shows about this. Episode 716 is all about placebo. Some people, this is an actual show guest said his mother had cancer and they, I don't know, the company changed the pill color from blue to orange or something. And she was like, these don't work. The blue ones work. And he's like, no, it's literally the exact same thing. And she's like, the blue ones were keeping me healthy. And it really affected her negatively because he couldn't, just no matter what, he couldn't explain or communicate effectively in a way that she would believe that the orange pills were the same as the blue pills.

35:02And there was a lot of placebo effect. And then she had kind of the nocebo from not getting it anymore. And she started to feel worse. And it went downhill. It was really sad and extreme. Just paint them blue. Yeah, I was thinking like, I told him during the show slash after the show, and I almost feel bad. I was like, hey, why didn't you go to a compound pharmacy and just be like, make these blue? And he's like, I didn't think of that. And then I felt really awful, because it's like his mother had cancer. And I gave him this solution in two seconds. And he's like, I just didn't know that existed.

35:31Or food coloring or something. I don't know. I mean, it's just crushing, right? But placebo is very powerful, I think is my point. Yeah, placebo and nocebo. I mean, with certain drugs, I mean, if we're talking about a cancer med, there's a psychological component, but mechanistically there cannot be a difference. But if we're talking about palliative drugs, I mean, we're talking about pain relievers, that's not curing anything. It's a symptom reliever. So yeah, placebo is a thing that exists. So if you think that you're going to get a better effect with Advil over Motrin, you might a little bit because that's a placebo, right?

36:05So, okay. But you know, this is just, again, that we're talking about pain relievers, palliative drugs for something like a cancer med that's doing something very specific in the body. There cannot be a mechanistic difference. Only you, the placebo aspect, like how you feel that can change, but that's it. I think with her, it was like her psychology of I'm going to be cancer kind of went downhill because she quote unquote, wasn't getting the right medication anymore, even though she totally was. And she started to just feel more tired and more pain and more lethargic. And some of that's the disease progressing, but others, it just sort of took the wind out of her sails just because of the color of the drug.

36:40So going back to your previous example with laundry detergent and butter and certainly any kind of food, there can be differences. Often we're choosing something that seems a little bit better to us. We get the picture here regarding generic names and brand names, but with the product itself, is there anything different whatsoever? Like with the food products, is there any sort of tiny, insignificant, different, anything at all? Yeah, so there can be tiny differences in the product overall. So when you take a pill, it's got the active ingredient in there. You've got aspirin or ibuprofen or acetaminophen or whatever it is, but it's not pure drug.

37:15It's not a big block of aspirin molecules. That makes sense. There's other things in the pill, and these are called excipients. So these are inactive substances. I mean, first of all, they're the medium within which to place the active ingredients so that you can take a pill easily. But then there could be preservatives, there could be coloring agents, right? You mentioned earlier as coloring agents. There's other stuff in there that's not related to the therapeutic effect of the drug. I always found it highly convenient that everything we needed to take in pill form was a white powder at the end of the day.

37:45I was like, wow, that's really, there must be, I must be missing something where everything I need to take is basically the same color and consistency. It's always magnesium sulfate or whatever it is, and then your drug is... Okay. Packed in there. Yeah. I remember there was those things that are not the drug, but in the pill. And I remember everyone's like, binders, watch out for binders. Don't take too many binders or whatever. I don't know what that means. Yeah. I think a binder is probably what sticks it all together in a pill form. So it's not just a big mess. And this machine was invented like, you know, a hundred years ago, whatever it is, where you get your amount of the drug and then the excipient, right?

38:19Whatever you're packaging it in, you go clamp and then you get your little tablet or whatever it is. And that was a big deal, right? I was like, look at how easy this is. We have it all measured out, and we have this pill, and then here you go. You just put it in a little box, and then everybody can buy the drug at the pharmacy, and you take it home, and you take it whenever you want. It's just so easy to distribute now. So, yeah. Oh, and these can vary. These things can vary from product to product, I assume? Yeah. So, I mean, not much, but there can be tiny differences that they might influence the bioavailability of the drug.

38:50We mentioned that earlier. So this is a word that describes how well your body absorbs the drug. So you ingest a pill, let's say you're taking a pill that goes into your stomach, your digestive system has to break down the pill, and then the active ingredient has to enter your bloodstream, it has to be absorbed and then enter your bloodstream, because then once it's in your bloodstream, it can be distributed around your body and do the thing the drug is supposed to do. So there can be slight discrepancies in how well that process occurs, depending on the product, it's not going to be like, totally not able to absorb or anything like that, but typically pretty negligible, but they do exist, very small variations.

39:26Okay, so the way the pill is made can have some slight differences in how well the drug works, but the drug itself is identical, and that's the most important part from the sound of it. Yes. Yeah, that is clearly the most important part. So we can't say that every brand is 100 % identical because it's not precisely true. There's all these other things that we're talking about, but it is true in the way that matters the most, and that's the drug itself. The drug, whether if it's, you know, Tylenol or acetaminophen or whatever it is, the drug is identical in every way with very few exceptions. And when you say drug, you mean the active ingredient.

40:01That's right. The drug, the actual therapeutic, right? So there's the molecule that is acting as a drug and affecting your physiology as per the definition of the drug that we mentioned up top. Okay. I'm just clarifying. I'm probably being super annoying in this episode, but I'm just clarifying it because a lot of this stuff is kind of confusing for me, having no background in this and I can't possibly be alone. Okay. It is confusing, yeah. You know a lot about this stuff, and I obviously do not. Speaking of shills, here's a word from the fine products and services that support this show. We'll be right back.

40:32Thank you once again for listening. All the deals, discount codes, and ways to support the show are on the website at jordanharbinger.com slash deals, or use the AI chatbot right there on the website and ask for that promo code. Or if you're super lazy, email me jordan at jordanharbinger.com, and I will freaking find it for you, you lazy sod. Now for the rest of Skeptical Sunday. Is there any possibility that one company makes a mistake, like they get a bad batch or something? And are there any examples of something going wrong? You mentioned there can be exceptions. What would that look like?

41:05Yeah, so this is obviously not common, but there can be mistakes. So there's a recent example, actually, that comes to mind. So a company called Novartis made a drug called Valsertan to treat high blood pressure. And then the period of exclusivity elapsed. And so, you know, as usual, other companies started making the generic, trying to cash in. But the problem is that a few other companies were using a slightly different methodology to make the drug the actual therapeutic that resulted in an unwanted side product called N-nitrosodimethylamine. And so that made it into the product. Now, this compound is, it's a pretty potent carcinogen.

41:41It's a very potent carcinogen. So it's, when I say that, like, you don't immediately want to think about toxic waste to glowing ooze or something like that. It's a normal molecule and we do ingest it. It's in bacon, it's in beer, it's in other things that we consume. We do come into contact with this molecule pretty regularly, but the thing is when we come into contact with it, it's very low doses and in this drug it was a much, much higher dose. Too high for a product that is going to be on the market. So this was a very bad thing. That is scary. So these companies, obviously they did this by mistake, I assume, or what's going on here?

42:14Yeah, this is, I mean, it's who would, it's a mistake. It was a careless mistake. Admittedly, it's a very foolish mistake. They missed this side product in their analysis. They made the drug and then they characterized it and they just, they didn't catch it. They didn't know it was in there. And then they went and submitted for approval without knowing that it was in there. Okay. But that should have been caught by who the FDA, I would assume or something, right? It should have been caught by the respective regulatory body that had domain over that, it should have. Yeah. And it usually is. Stuff like this almost always is.

42:46I can't say in this example why it wasn't caught. I don't know why. But it was an oversight on their part, on the regulatory body, and it was an oversight on the part of the each of the handful of companies that made it this way. That is terrifying. Was this linked to any deaths or cancers or anything like that? No, not specifically. There definitely was not any documented case linking them rigidly. But I mean, there could be, we just don't know, right? Because this is very recent, so there could be future cancer diagnoses that mechanistically stem from this product. Maybe none, but maybe some.

43:20And if that were to be the case, we would not know. We're not going to know. But regardless, it was caught, and then the faulty methodology, you know, it has to be addressed and modified. In fact, in response to this exact situation, there's now new regulation that has been put into place by the FDA to prevent this exact error moving forward. So now all companies have to test drugs for the presence of nitrosoamines, which is the particular type of molecule that caused this problem. Okay. So there was an error, and then there was what sounds like an appropriate reaction to the situation. And that's somehow heartening, I guess, unless you're one of the people who took that medicine for years on end or something to treat high blood pressure, and then maybe you're sweating a little bit from that.

44:02Yeah. And I don't know exactly how long it was on the market before it was discovered. I don't think it was that that long. But yeah, I mean, to me, this is an appropriate... People want to pretend that the FDA is this hopelessly corrupt agency, but it's not. It's a baseless sentiment. They reacted to a situation and implemented a new regulation to prevent this happening in the future. So FDA or any other such regulatory body, they're not immune to error. But on the whole, these regulatory bodies are massive, profoundly necessary safeguards, which ensure that there aren't harmful substances in drugs that go to market.

44:38That's the whole point of them existing. Do you know how they found that, that harmful substance in there if the FDA didn't? Like, who's looking at drugs after they're already out? I don't know. Or perhaps they caught it later or, yeah, I would have to look into that. Yeah, I'm curious. I just thought of that because I'm thinking like, I don't go in my Tylenol and go, let me just make sure this is only acetaminophen. Right. Yeah. Somebody characterized it later. I don't know if it was in academia or if it was another company or if it was the regulatory body that came back to it again or something.

45:07Yeah. It seems like if you're making a generic version of a drug, you might go, all right, well, we have to make sure this is, oh, crap, there's just all this other stuff in there. Well, how come that happens to us and it doesn't happen to them? I don't know, test their stuff. Oh my God, they have it too and nobody knows. But then you're 10 years in or 20 years in, right? So that's been a long time if that's how they catch it. Yeah. Well, that's why if you change the methodology, right, if you don't use exactly the same synthetic pathway, I mean, even if you do use the same synthetic pathway. You can make a mistake, so you still have to test everything rigorously, but especially if you change the pathway somehow, you got to test and make sure at the end that you have what you're supposed to have and nothing that you're not supposed to have, pretty much.

45:44Yeah, I do understand that blind anti-government sentiment, which is more common now seemingly, tends to contaminate the way people view these kinds of government agencies. The FDA has been under crazy fire in the past few years, and a lot of it just seems a little unhinged. I mean, some of it maybe is legit, but a lot of it is almost like they're completely funded by big pharma. And I'll ask you that in a second. But are there examples we can point to that might rehabilitate that idea or the idea that they're not terrible and corrupt? Yeah. I mean, there's so many examples. I mean, people who are super, super anti-pharma, one of their favorite examples to bring up is thalidomide to try to cite the harm that pharmaceutical drugs can have.

46:24And that is legitimate because people don't know what thalidomide is, this was in like the 1950s or so. It was a drug that was marketed. It was supposed to cure morning sickness, which it did. But then the other enantiomer, remember we talked about the two mirror images. At the time, this was pretty much everything was marketed in racemic form with both the mirror images. So the other mirror image, which was also in the pill, caused birth defects, fairly severe ones. So there were a bunch of babies that were born with these pretty terrible birth defects. Yeah, I think it was like missing limbs and stuff like that.

46:56More like little kind of like claw hands and feet, just really deformed limbs, hands and feet in particular. Yeah, very tragic. It is. It's awful. I looked up some pictures of this before. Focomelia is the name of the condition of these people. I looked it up because it's in Billy Joel's We Didn't Start the Fire. And this was that drug was in common use in Europe for morning sickness. And I think it is. I know I'm such a dork for saying this, but it's Lebanon, Charles de Gaulle, California baseball, stark weather, homicide, children of the little mind. right? Remember that sort of phrase? And I was like, what the hell was that?

47:29I'm not a fan of him, but I don't remember. I guess I'm not either. That song's just extremely catchy. You can't really, can't hate on that. Well, anybody that puts thalidomide as a song lyric, that's interesting. I mean, you gotta give them a little credit for rhyming thalidomide with anything. I'll give him some credit for that, yeah. Okay, got a little sidetracked, but back to the point. This is why we are talking about this. That happened in Europe, as you said. Do you want to guess why it didn't reach America. Okay. Well, was it the FDA? That's right. The FDA, right? The FDA saved Americans.

48:00So the FDA kept asking for more tests because they weren't convinced of the safety. So it wasn't able to reach the American market before reports of the birth defects started coming out. Wow. Okay. Well, somebody deserves a freaking medal for that one, because probably hundreds of thousands of kids dodged figurative bullets on this and families. Probably not hundreds of thousands, but well, it depends on how long it would have gone. I mean, in Europe, there were a few hundred, maybe a thousand cases. I'm not sure exactly, but I mean, it's a lot. But for even one to occur in America would have been a tragedy.

48:33And you mentioned a medal. Somebody did get a medal, actually. They got a Presidential Medal of Honor for this, for preventing thalidomide from being sold in America. But there's more to it than it's not just about, oh, there was this one drug that was dangerous and we got saved from it. This was the 1950s. So we're talking about, this is a long time ago in the timeline of drug development, so it's not as sophisticated. It was not as sophisticated then as it is now. And that was a moment where we learned a valuable lesson about enantiopurity. Again, we're talking about enantiopure versus the racemic, the two mirror images.

49:05So new regulations as a result of this were put into place in terms of, first of all, testing all possible stereoisomers and requiring enantiopure synthetic pathways if necessary. So going, okay, if there's two mirror images, let's make sure the wrong one doesn't do something terrible. Right, test both instead of treating it like one chemical. Test both to see if they do different things. Okay. Exactly, because in some cases they do. Usually they don't, but maybe they do. But even more important than that, this is a big deal. New regulations were put into place because of this tragedy in terms of fetal toxicology testing.

49:39So specifically testing in terms of what a drug will do to a developing fetus. And this was, it's a little shocking to think about, but this was not required before this incident. There was no testing at all on what drugs would do to a pregnant mother that had a developing fetus inside of her. Wow. So after this, that became a very stringent regulation in place that was yet another safeguard that the industry then had to comply to. They have to do these fetal toxicology testing on any drug that goes to market because of this incident. So this is, again, you know, the industry reacted to ensure that a tragedy like that never took place again.

50:17And it never has. I mean, not of that magnitude, certainly. Bad things sometimes happen. But look, I'm an eternal optimist. We can face them head on, admit what went wrong, implement changes for the future as long as everybody's willing to do all those things. Still terrifying, though, man. It makes me feel really blessed that I'm not dependent on any medications, at least right now for the time being. Sure. Yeah, it's better to take no drugs. but people need drugs, right? Because we're not living as primitive people. We understand the human body. We can make these compounds that help us, but we make them.

50:51We are humans, our institutions, and our industries are comprised of humans. We're not gods. We're not infallible. Mistakes happen, and no one is denying that. But these regulatory bodies are here for very important reasons, and they do very important things. So people need to know and understand that. Because without these, the private sector would not self-regulate ethically. The private sector, their only driver is profit. So they have to be kept in check somehow. That's the purpose of these regulatory agencies. Otherwise, they would do us harm, maybe not intentionally, but or maybe intentionally for profit and hope they get away with it.

51:24I mean, it's not unheard of, I suppose. Not intentionally, probably. I mean, pharmaceutical companies are not these vile monsters that are going, ha ha ha, how can I poison the world? It's just so infantile. And yet the narrative is shockingly prevalent. So it's not like that. They're not villains. But the point is that under capitalism, profits will be prioritized over everything else. Nobody denies that. So certainly, you know, if they can cut corners, if they can save money somehow, if they can, whatever it is, they will do it, even if it results in harm. So that's the purpose of the regulatory bodies.

52:02That's why they're established. So prior to the FDA, anybody could sell anything and make any claim about what it does. They could say anything they want, put something in a bottle and go, this cures your blah, blah, blah, it cures your warts or whatever, you know, and they could just sell you a drug that doesn't work. Snake oil. Yeah, just snake oil. This was perfectly legal. You could sell anything you want, or it could even be harmful to the consumer. It is just a Wild West, totally unregulated, very dangerous landscape. So this is why the FDA exists. These regulatory bodies are the checks and balances that we absolutely need.

52:38I just think it's scary because the consequences of being wrong are so freaking enormous. And by the way, people are going to be upset about what we just said about them not being villains or whatever. If you want to hear a counterpoint, episode 709 with John Abramson, Dr. John Abramson, how big pharma broke American healthcare. It's not about like the FDA and drug companies being evil, but it's about how the U.S. health care system just is horrendous. And I think which is much broader. Yeah, I don't think you would disagree with anything he says, really. I mean, he's mostly railing on our crap ass, a super expensive health care system that we have here that's just been ravaged by corporations, which extends far beyond the pharmaceutical industry, for sure.

53:17It's way beyond the scope of what we're talking about. I just want to give people a counterpoint whenever they're like, you're being paid. You're a shill. I'm like, here's me not being a shill at all and actually shooting myself. If I were a shill, like me getting fired from that job, episode 709. We're two self-employed guys sitting in our living rooms or offices in our homes. Right, with no pants on. Or is that just me? I've got shorts. But the consequences of being wrong about this stuff, like I said, are just so freaking huge, right? The opiates thing, Purdue Pharma, that comes to mind. I mean, that's what people are thinking.

53:47They're not evil. Look at the Sackler family. Those sons of bitches killed hundreds of thousands of people with their crap. And they're not wrong about that. No, they're not. It's just that, okay, the opiates thing, to be fair, opiates are important painkillers. They should exist. They are important drugs that should exist. They also are very addictive. That people have a tendency to abuse them. It's a much broader societal problem. You can't just blame pharma for abusive painkillers. It's like blaming Budweiser for alcohol abuse or something. I mean, granted, it's a little more nuanced because we're talking about prescription drugs.

54:22So doctors and the medical establishment, there's a broad range of implications here. Admittedly, you bring up a specific example of deceptive marketing that is not ethical, it is unfortunate. But we're talking about these isolated incidents that have much broader implications than just going, the bad pharma people, you can't tear down this entire system because of these examples, you know what I mean? Yeah. Speaking of an example that's not exactly the same thing, what about the Tylenol? cyanide thing. You remember that? A bunch of people died because of poison Tylenol. It was like a local Midwest thing, maybe.

54:55It was in the 80s. Chicago. I mean, I'm vaguely aware of it. But this is like somebody tampered with the product, right? I guess. I don't know. I don't think anybody really knows who did that or why. I mean, the company is not going to knowingly poison consumers. That's just ridiculous. They're just inviting lawsuits for absolutely no reason. So yeah, I mean, some deranged person went to stores and added cyanide to Tylenol bottles. That's insane. But serial killers exist, very much outliers, right? Just a handful of people around the world like this, but people do these really bizarre things sometimes.

55:29I guess I was wondering what you thought about that. Again, it was a way off example, but it's not like they're making cyanide pills on the conveyor belt next to the Tylenol, and it flipped over into there and landed in the bottle. I mean, this is somebody unscrewing the lids. And at that time, I think there were no seals. It was just like, oh, you can push hard on the child proof cap if that even existed. Right. Pop a cyanide in there or whatever, add something in. I guess it seems like people who are just generally anti-establishment can't figure out that being anti-government in such a scenario, it actually means being pro-corporation in ways that they probably would not advocate or agree with.

56:05They're also anti-pharma and things like that. Yeah. I mean, this is a thing that makes me laugh a lot. It's very hypocritical with this stuff. People want to rage against the machine. It's just like a sentiment that we all have to an extent. But when it's in this ignorant way, it's very sophomoric. There's not just one power to rage against. There's a public sector, and there's a private sector. We need both. And the point is that neither should have tremendously more power than the other. We don't want an authoritarian government that controls all labor and manufacturing. We don't want that.

56:39But we also don't want an out of control corporatocracy that has the government in its pocket and uses lobbying or bribery to escape any kind of regulation and just squeeze the economy dry and totally screw us over. They're both bad situations. Even in authoritarian regimes, I remember that China had, I can't remember what was in the milk. Do you remember the milk thing in China where this guy, the company had added some sort of chemical agent to milk to basically just make the quantity larger. And it was obviously toxic. And it killed a bunch of babies. And they executed him for that. Wow. It was just a really crappy shortcut.

57:16So it's not you can't even avoid this kind of thing. You basically you need the FDA. You can't just be like, hey, we're going to control everything from start to finish with manufacture because even that doesn't work. Like you really do need these kinds of checks and balances. And it seems like, speaking of corporatocracy that uses lobbying and bribery to escape regulation, it seems like, if anything, we're closer to the latter. We're closer to that idea. We are. I mean, that's, like, I understand to an extent being anti-government, but when you then try to rage against regulatory bodies that are trying to keep an out-of-control corporatocracy in check, that's just crazy to me, right?

57:53Unfettered capitalism is the issue. I think people tend to regurgitate this like Reagan-esque mantra of, we need less government, we need less government. And this is just like, it's a smokescreen put in place by huge corporations to try to garner public support for their own deregulation, right? It's just the corporations want people repeating this sentiment because they want regulations to be even looser upon themselves. It's a propaganda campaign, basically. And it got a touch political, but I think it's funny that earlier, we're talking about how we need capitalism for innovation and the patents and everything to protect that innovation.

58:29And then we're also saying it's almost like we're having a nuanced discussion that is not completely tribal and one sided, Dave. I don't know. Are we allowed to do that? I'm not sure we're allowed to do that, man. We're bold. We're paving the way. But even fans of small government can agree with what you're saying is what I'm trying to say here. I mean, I hope so. Right. Because we don't want to go back to prior to regulatory bodies where anybody can sell you anything with nobody there to check if it's safe or effective or any, I mean, it's just, this is terrible, right? We don't, you know, I do stick to the science for the most part, but there are these broader ramifications that you got to elucidate.

59:03So sometimes when you're talking about science, it turns into social commentary and this kind of balancing act between the private and the public sectors that were, seem to be destined to try to put in balance for the rest of human civilization, I think. What about, before I let you go here, what about the idea, and I hear this all the time, and I see it in podcasts all the time, big pharma pays the FDA's budget. It's something like nine, and the percentage goes up depending on the amount of caffeine the person's had who's screaming it into the microphone. But they'll say like, it's 90 % budget is paid for by big pharma.

59:35So of course, they're going to do what they want. You know, have you seen this before or heard this before? I think so. I mean, I tend to tune it out. I mean, it doesn't work like that, right? It's a federal institution. It's not like they pay the budget. That's not how it is. I mean, there are fees that have to be paid for product approval. That's true. You know, I hesitate to comment. I don't know anything about like the pure bureaucratic side. But yeah, I don't know. I tend to just this idea that the FDA is in big pharma's pocket and just does whatever they say. There's just no there's no basis to it.

1:00:06Well, all right. Maybe less snarky humor in this one than usual, but I've definitely gotten a broader perspective on all of this. And hopefully those listening have as well. I'm still nervous about medication and prefer to take it only when I absolutely have to. But I'm also super grateful that we even have this technology and the science behind it is frankly really amazing. So thank you again, Dave, for joining us on Skeptical Sunday. Thanks so much for listening. Topic suggestions for future episodes of the show can always come to me, Jordan at JordanHarbinger.com. Pretty much every episode of this show that we've done on Skeptical Sunday has been a fan suggestion.

1:00:40So you guys are money. Keep them coming. Jordan at JordanHarbinger.com. Show notes at JordanHarbinger.com as well. Transcripts are in the show notes. Advertisers, deals, discounts, and ways to support the show are all at jordanharbinger.com slash deals. I'm at Jordan Harbinger on both Twitter and Instagram, or just connect with me on LinkedIn. You can find Dave at Professor Dave Explains on YouTube, or of course, linked in the show notes. This show is created in association with Podcast One. My team is Jen Harbinger, Jace Sanderson, Robert Fogarty, Ian Baird, Millie Ocampo and Gabriel Mizrahi.

1:01:13Our advice and opinions are our own, and I'm a lawyer, but I'm not your lawyer, so do your own research before implementing anything you hear on this show. Remember, we've rised by lifting others. Share the show with those you love, and if you found the episode useful, please share it with somebody else who can use a good dose of the skepticism that we doled out here today. In the meantime, I hope you apply what you hear on the show so you can live what you learn, and we'll see you next time. If you're looking for another episode of the Jordan Harbinger Show to check out. Here's a trailer with FBI hostage negotiator, Chris Voss.

1:01:46Chase Manhattan bank robbery. I'm a second negotiator on the phone. Hugh McGowan is the commander of the NYPD team. He puts me on the phone. He takes this guy off. He says, you're up. You're next. This is what I want you to do. You're just going to take over the phone and say you're talking to me. And we're going to do it really abruptly. My point is to get a hostage out, which is what the hostage negotiator is supposed to do. And somebody hands me notes is ask him if he wants to come out. That was somebody that was listening. My friend, Jamie, Jamie Cedeno. Jamie's sitting there and something in Jamie's instincts is telling him that this guy wants to come out more than anything else.

1:02:20He just hears it and he writes, ask him if he wants to come out. I see a note popping in front of my face. So I go, do you want to come out? And there's a long silence on the other end of the line and the guy says, I don't know how I'd do that. Which is a great big giant yes. Yeah. Everybody goes like, holy cow, okay, get him out of there. I'm talking, I'm talking, I'm talking again, probably about, I don't know, maybe half an hour later, another note comes in my hand. I don't know where it's from. As it turns out, it's from Jamie again. And the note says, tell him you'll meet him outside. And I say to him, How about this?

1:02:59How about if I meet you out front of the bank? And he goes, Yeah, I'm ready to end this shit. I get out there. I get on the PA. I start talking to him. So I say, hi, it's Chris. I'm out here. Standard operating procedure is to barricade the exit from the outside so a bad guy suddenly doesn't run away. So SWAT has barricaded the bank from the outside, which everyone has forgotten. so i'm trying to talk this guy out the door we don't know how many bad guys are inside we don't know how they're going to react we don't know they're going to start shooting we don't know what the hell's going to happen he comes to the door oh god i that was because he rattles the door and he's like he's nervous right i mean no crap i'm trapped in here now yeah on the outside we go nah what do we do we forgot to unlock the door and our bad guy is kind of like oh Play games with me, huh?

1:03:53For more from FBI hostage negotiator Chris Voss, including negotiation and persuasion tips, along with a few crazy stories, check out episode 165 of The Jordan Harbinger Show.

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