WEBVTT - Biosimilar Drugs 0:00:00.160 --> 0:00:07.160 Brought to you by Toyota. Let's go places. Welcome to 0:00:07.360 --> 0:00:15.040 Forward Thinking. Hey there, and welcome the Forward Thinking, the 0:00:15.200 --> 0:00:18.239 podcast that looks at the future and says, no pills 0:00:18.239 --> 0:00:20.320 gonna cure my ill. I got a bad case of 0:00:20.360 --> 0:00:24.880 loving you. I'm Jonathan Strickland, and I'm Joe McCormick. And Jonathan, 0:00:24.920 --> 0:00:28.240 you're back. I am back, but you might notice this 0:00:28.320 --> 0:00:30.840 is a really appropriate thing for us to cover today 0:00:30.880 --> 0:00:36.200 because my voice is dying. I've had I've been fighting 0:00:36.200 --> 0:00:38.599 off a little bit of a cold for it ever 0:00:38.640 --> 0:00:41.560 since I got back. Did you get cruise crud? Either 0:00:41.640 --> 0:00:45.680 cruise cut crud or the European boogie flu? I don't know. 0:00:45.800 --> 0:00:48.720 I mean it was. I had a great time. I 0:00:49.159 --> 0:00:52.480 sailed around the British aisles. We told the listeners many 0:00:52.520 --> 0:00:55.920 untrue stories or might not be dead. Yeah, I got 0:00:55.920 --> 0:00:58.080 a lot of concerned tweets that was dead. I don't 0:00:58.120 --> 0:01:02.040 think we said Dad was heard. It was almost definitely. 0:01:02.040 --> 0:01:05.200 Didn't tell anyone you were down. That's good. So we 0:01:05.240 --> 0:01:10.080 may have mentioned Quidditch made dismissive comments about France. I was, 0:01:10.120 --> 0:01:13.679 in fact at a castle where they did shoot some 0:01:13.720 --> 0:01:18.080 of the Quidditch scenes from Harry Potter on Castle Historic 0:01:18.120 --> 0:01:20.640 Comma The Percy's I was there for Hotspur, my wife 0:01:20.640 --> 0:01:23.520 was there for Harry Potter. Anyway, none of that has 0:01:23.520 --> 0:01:26.120 anything to do with what our topic is today, but 0:01:26.400 --> 0:01:28.120 the fact that I was talking about feeling a bit 0:01:28.160 --> 0:01:32.120 under the weather does kind of because we're talking about biosimilars, 0:01:32.520 --> 0:01:36.119 a type of drug, and you may have heard this term, 0:01:36.240 --> 0:01:38.880 and some of you may even be very familiar with it, 0:01:38.959 --> 0:01:43.200 but I to to just be honest, I had heard 0:01:43.240 --> 0:01:46.400 the term, but didn't really understand it until we started 0:01:46.400 --> 0:01:49.080 doing research for this episode. I think I think I 0:01:49.120 --> 0:01:52.640 knew nothing about it. Yeah, I think that I completely 0:01:52.680 --> 0:01:55.160 misunderstood it. We were talking right before we started up 0:01:55.200 --> 0:01:57.800 about how it was sort of a difficult topic to 0:01:57.800 --> 0:01:59.760 to wrap our heads around, partially because some of the 0:02:00.040 --> 0:02:03.800 parding about it is a little bit confused itself. Yeah, 0:02:04.040 --> 0:02:08.520 it's not misleading, at least not clear right or just 0:02:08.560 --> 0:02:11.920 not going into depth. I think I didn't really understand 0:02:12.240 --> 0:02:16.799 before the difference between biosimilar drugs and generic drugs, right 0:02:17.040 --> 0:02:19.600 and and and biosimilar drugs been in the in the 0:02:19.639 --> 0:02:22.880 press a little bit lately because of some stuff floating 0:02:22.880 --> 0:02:27.120 around the f d A hopefully not literally that that 0:02:27.120 --> 0:02:28.919 that has to do with with the way that these 0:02:29.000 --> 0:02:31.720 drugs are are going to be regulated in maybe the 0:02:31.760 --> 0:02:35.119 near future, uh, maybe a little while from now, but 0:02:34.960 --> 0:02:37.680 but yeah, So, so there is a distinct difference between 0:02:37.760 --> 0:02:42.440 biosimilar drugs and generic drugs. And let's let's let's figure 0:02:42.480 --> 0:02:45.399 that out. Let's lay down these these ground definitions, right, 0:02:45.440 --> 0:02:48.079 So first, let's just start with just the basic idea 0:02:48.080 --> 0:02:53.120 of what is a drug. Let's manufacture some drugs. Wow 0:02:53.280 --> 0:02:55.320 this episode with Downhill in a hurry. All right, So 0:02:55.600 --> 0:02:57.919 the drug is, at its most basic level, some sort 0:02:58.000 --> 0:03:01.960 of molecule that has a pharmacle logical effect on something organic. 0:03:02.040 --> 0:03:04.959 And we are going to talk about drugs for humans 0:03:05.000 --> 0:03:07.840 because that's what we are. I mean, I don't want 0:03:07.840 --> 0:03:09.919 to speak for all of us. I'm not I am 0:03:09.960 --> 0:03:14.400 definitely not almost sure. I'm definitely not a reptilian. I'm 0:03:14.440 --> 0:03:18.440 not going to not say that I'm a reptilian. Okay, 0:03:18.840 --> 0:03:21.359 I'm mostly interested in drugs for wizards. Can we talk 0:03:21.400 --> 0:03:26.000 about those. We'll get back to quidditch later. So typically 0:03:26.000 --> 0:03:28.040 when we talk about drugs, we're talking about ones that 0:03:28.080 --> 0:03:32.840 were designed through chemistry in a lab. That's the majority 0:03:32.880 --> 0:03:35.440 of the drugs we use today are of that category. 0:03:35.520 --> 0:03:38.000 Not all of them are. Some of them are biologic 0:03:38.240 --> 0:03:42.760 as opposed to, uh the the chemical approach, but we'll 0:03:42.760 --> 0:03:46.080 get into that. So when a pharmaceutical company develops a drug, 0:03:46.240 --> 0:03:48.320 it's really trying to build a molecule meant to have 0:03:48.360 --> 0:03:51.720 a particular effect on the person taking the drug, whether 0:03:51.760 --> 0:03:55.400 it's to fight a particular illness or alleviate symptoms or 0:03:55.440 --> 0:03:58.119 something along those lines. It's it's it's meant to make 0:03:58.160 --> 0:04:00.760 some kind of chemical change in your body in order 0:04:00.800 --> 0:04:04.240 to do a stuff right. Right, And typically the active 0:04:04.360 --> 0:04:07.440 ingredient is the drug itself, but an active ingredient is 0:04:07.480 --> 0:04:09.760 not the only ingredient in most drugs. You tend to 0:04:09.800 --> 0:04:11.400 have a lot of other stuff that is there. Maybe 0:04:11.480 --> 0:04:14.440 it's to act as almost like a catalyst. Sometimes it's 0:04:14.480 --> 0:04:17.359 just a filler to a carrier system to get the 0:04:17.360 --> 0:04:21.120 stuff into your stuff. Sure, yeah, so you we in 0:04:21.200 --> 0:04:25.599 the getting over into the generic drug area. UM, you 0:04:25.600 --> 0:04:29.120 would first call one of those drugs like the main 0:04:29.200 --> 0:04:31.320 one that has already been developed by a company. It's 0:04:31.360 --> 0:04:34.400 been uh filed with intellectual property, so it has its 0:04:34.440 --> 0:04:38.320 own proper name that does not necessarily relate to any 0:04:38.360 --> 0:04:41.560 of the chemicals inside that drug. It's usually a pun 0:04:41.640 --> 0:04:43.960 of some kind. Yeah, yeah, you get some or you'll 0:04:44.000 --> 0:04:46.440 just get like it will sound vaguely scientific, but then 0:04:46.480 --> 0:04:48.880 you realize that that's just a brand name that someone 0:04:48.960 --> 0:04:51.640 came up when they said this is testing. Well, yeah, 0:04:52.000 --> 0:04:54.320 maybe it would help to have an example to continue 0:04:54.360 --> 0:04:58.880 through this. Let's do aspirant. I was gonna make one up. Okay, 0:04:58.960 --> 0:05:00.599 go go ahead, make one up. Well, let's say you 0:05:00.640 --> 0:05:03.960 invent a small molecule drug that causes rapid balding for 0:05:04.000 --> 0:05:06.840 people who don't like to have haircuts. You know, they 0:05:06.880 --> 0:05:10.640 just don't want to deal with it. Advanced rapid balding. 0:05:10.760 --> 0:05:13.480 And I feel like I'm being attacked in this episode 0:05:14.400 --> 0:05:17.559 talking about I feel like I'm I've been advanced rapid 0:05:17.600 --> 0:05:21.640 balding for years. So this drug, the brand name version 0:05:21.680 --> 0:05:24.880 of it that is patented by the original drug innovator, 0:05:25.000 --> 0:05:29.080 is called Scalp Extra. Scalp Extra, that's that's the that's 0:05:29.160 --> 0:05:33.600 the brand name, brand name. Yeah, so there's an active 0:05:34.000 --> 0:05:39.839 ingredient in scalprexa. Uh what Scalp extra. Sorry, Um, well 0:05:39.880 --> 0:05:43.240 I don't need it, obviously, I've already it's it's worked 0:05:43.279 --> 0:05:47.040 on me. So Scalp Extra is the brand name. What 0:05:47.200 --> 0:05:52.200 is the active ingredient? Makes something else up? Uh, it's sugar. 0:05:53.240 --> 0:05:54.960 I don't know what it is. It's a chemical, I 0:05:55.000 --> 0:05:56.919 don't I know, But you can just make up a 0:05:57.000 --> 0:05:59.159 name for a chemical. Two for the purposes of this, 0:05:59.800 --> 0:06:04.200 It's called cubal hydride. Alright. Cubal hydride is the active 0:06:04.320 --> 0:06:09.880 ingredient in scalp extra. Alright, cubal hydride. So, uh so 0:06:10.320 --> 0:06:13.760 in the in the terms of generic drugs, you would 0:06:13.800 --> 0:06:17.680 have scalpexor, which is your reference drug, all right, and 0:06:17.720 --> 0:06:22.279 then cubal high what was it? Cub hyd cuble hydride 0:06:22.880 --> 0:06:26.039 is your is your actual active ingredient that becomes the 0:06:26.080 --> 0:06:31.479 generic term for that drug, all right. So generics are 0:06:31.520 --> 0:06:34.120 are drugs that have the same active ingredient as a 0:06:34.160 --> 0:06:37.280 brand name, and they are meant to have the same 0:06:37.320 --> 0:06:41.320 pharmacological effect as the reference drug that brand name drug 0:06:41.320 --> 0:06:44.640 Scalp Extra in this in this example that we have created. 0:06:44.760 --> 0:06:47.120 So if they're the same thing, in what sense is 0:06:47.160 --> 0:06:50.479 the generic different? Well, it has basically just to do 0:06:50.520 --> 0:06:53.400 with intellectual property law, right pretty much. Yeah. Yeah, So 0:06:53.560 --> 0:06:57.800 after the patent lifetime of the original patent on that 0:06:57.920 --> 0:07:01.560 drug expires for the drug innovator, then another company can 0:07:01.600 --> 0:07:03.080 come along and say, well, I want to make this 0:07:03.200 --> 0:07:07.240 same drug, but basically the only thing they can't do 0:07:07.400 --> 0:07:10.160 is call it by the same name. So and and 0:07:10.240 --> 0:07:14.240 frequently the some of the non active ingredients will be different, right, 0:07:14.560 --> 0:07:16.760 which also partially explains why if you've ever noticed that 0:07:16.880 --> 0:07:21.080 sometimes generic drugs don't work exactly the way that that 0:07:21.080 --> 0:07:23.520 that a brand name drug does. It could be a 0:07:23.520 --> 0:07:27.560 placebo effect, or it could be a genuine chemical difference 0:07:27.600 --> 0:07:29.280 in the way that the drug is entering your system. 0:07:29.440 --> 0:07:32.440 Right there. There can be cosmetic differences to it can 0:07:32.480 --> 0:07:34.760 be shaped, your color different, well, it might be a 0:07:34.800 --> 0:07:39.320 pill versus like the gelatine capsule type stuff. It all depends, right. So, 0:07:39.880 --> 0:07:42.360 the in the United States, the Food and Drug Administration 0:07:42.440 --> 0:07:45.400 has very specific rules for generic drugs and says that 0:07:45.480 --> 0:07:47.600 generic drug must be identical or within a range of 0:07:47.640 --> 0:07:50.800 bioequivalence to the reference drug. So it has to be 0:07:50.840 --> 0:07:56.280 that way. Now, biosimilar drugs are different from this. They 0:07:56.280 --> 0:08:01.080 are not meant to be chemically identical to a reference drug. 0:08:01.280 --> 0:08:05.200 You still do have a reference drug, so they're intended 0:08:05.240 --> 0:08:08.080 to produce medicinal effects that they are. One, they're not 0:08:08.120 --> 0:08:11.560 created through chemical synthesis, and the molecular structure is much 0:08:11.680 --> 0:08:15.720 larger and more complex than traditional brand name drugs or generics. 0:08:16.680 --> 0:08:20.040 So you first start off with a biologic therapy of 0:08:20.080 --> 0:08:22.920 some sorts. So this is this is similar in a 0:08:22.960 --> 0:08:25.840 way to the reference drug we talked about a second ago, 0:08:25.920 --> 0:08:28.720 the brand name drug, but in this case it's biologically 0:08:28.840 --> 0:08:35.000 derived UM and biosimilar is meant to replicate the effects 0:08:35.040 --> 0:08:39.079 of the reference drug, the biologic therapy, but it doesn't 0:08:39.120 --> 0:08:43.360 have to at all molecular lee resemble that reference drug, 0:08:43.800 --> 0:08:47.319 right because Okay, So, biological therapies are products that are 0:08:47.360 --> 0:08:51.679 made from biological sources, their extractions from cells or tissues 0:08:51.880 --> 0:08:55.640 or or stuff that is made inside cells and tissues. Uh. 0:08:56.160 --> 0:08:59.480 They can also be called biopharmaceuticals or biologics, and they 0:08:59.559 --> 0:09:03.719 include things like like like hormone therapies, vaccines, blood components, 0:09:03.800 --> 0:09:08.600 gene therapies, anti venom or antitoxin, insulin, stuff like that, Right, 0:09:08.679 --> 0:09:12.160 And so keep in mind we're we're talking about both 0:09:12.160 --> 0:09:16.640 generics and biosimilars are supposed to achieve the same results 0:09:16.760 --> 0:09:19.679 as their references. But in the case of generic drugs. 0:09:20.240 --> 0:09:22.839 When you break it down chemically, it is for all 0:09:22.880 --> 0:09:25.720 intents and purposes, identical to the reference. It does the 0:09:25.800 --> 0:09:28.160 same thing because it is the same right, right, It's 0:09:28.160 --> 0:09:31.320 it's a chemical structure, um and and biologic therapies are 0:09:31.360 --> 0:09:34.720 are more complicated because of a the way they're produced 0:09:34.720 --> 0:09:37.400 and be the stuff that they're made of. Right. So 0:09:38.120 --> 0:09:40.360 if you want to have like an analogy that's not 0:09:40.480 --> 0:09:44.439 drug related, you could say that if you look at 0:09:44.520 --> 0:09:48.439 a catapult and a giant sling shot, they both can 0:09:48.559 --> 0:09:52.920 propel an object a very great distance. They do it 0:09:53.160 --> 0:09:55.400 in slightly different ways, but the end result is the 0:09:55.440 --> 0:09:59.080 same and they don't physically resemble one another, right, So 0:09:59.200 --> 0:10:01.319 you could if you could design it in such a 0:10:01.320 --> 0:10:03.560 way where some of the same elements some of the 0:10:03.559 --> 0:10:06.760 same elements, which is true with biosimilars as well. So 0:10:07.120 --> 0:10:09.240 that's why I wanted to say, like again, you've got 0:10:09.240 --> 0:10:13.080 to think of biosimilars as being an attempt to create 0:10:13.160 --> 0:10:17.679 the same effect as some other reference, but it isn't 0:10:17.720 --> 0:10:20.560 identical to the reference. Not only that, but if you 0:10:20.600 --> 0:10:24.520 have two different companies trying to make biosimilar drugs, so 0:10:24.559 --> 0:10:30.080 you've got your reference biological therapy, right, that's created by somebody. 0:10:30.320 --> 0:10:31.720 You have two other companies that want to make a 0:10:31.720 --> 0:10:37.000 biosimilar therapy using that first one as its reference. The 0:10:37.040 --> 0:10:41.560 two biosimilar therapies won't resemble one another either. They will 0:10:41.600 --> 0:10:44.400 resemble the they won't physically. Yeah, I mean, I mean 0:10:44.400 --> 0:10:48.439 because because you have to reverse engineer. Because we'll look 0:10:48.520 --> 0:10:49.800 into this in a minute. But but but the way that 0:10:49.840 --> 0:10:53.719 these things are patented, Uh, people don't or companies rather 0:10:53.840 --> 0:10:58.760 don't have to write down everything about their process. They 0:10:58.840 --> 0:11:02.240 just they just patent the end result and so um so, 0:11:02.240 --> 0:11:04.520 so when when another company comes along and tries to 0:11:04.559 --> 0:11:08.000 reverse engineer that process, then what they come up with 0:11:08.120 --> 0:11:12.560 might be wildly different. Yes, And so, as we've already 0:11:12.559 --> 0:11:15.960 alluded to, making these things is complicated. I mean, you're 0:11:16.280 --> 0:11:19.800 you're talking about like almost like growing a drug as 0:11:19.800 --> 0:11:24.200 opposed to synthesizing one through chemistry. And because of this, 0:11:24.320 --> 0:11:27.880 the whole process requires a lot of precision and expertise. 0:11:27.920 --> 0:11:30.520 It is not an easy thing to do. It's not 0:11:30.600 --> 0:11:33.960 easy to produce it on a mass scale either. So 0:11:34.160 --> 0:11:38.360 for uh, that reason, a lot of biologic therapies tend 0:11:38.360 --> 0:11:41.640 to be incredibly expensive because it's not it's not easy 0:11:41.679 --> 0:11:43.480 to do, and it's not easy to do on a 0:11:43.520 --> 0:11:47.680 big scale. So in order to balance that out, companies 0:11:47.760 --> 0:11:51.520 end up charging more for their various biologic therapies. It's 0:11:51.559 --> 0:11:53.679 not true in every single case, but in a lot 0:11:53.760 --> 0:11:56.960 of cases it is, so there was there's hope that 0:11:57.040 --> 0:12:01.240 biosimilars can help bring that cost down own. But we'll 0:12:01.240 --> 0:12:03.800 get into how that gets a little complicated and just 0:12:03.880 --> 0:12:07.760 a little further um. Now, the other issue we need 0:12:07.800 --> 0:12:10.640 to talk about is the idea of testing drugs. We've 0:12:10.640 --> 0:12:14.640 talked about drug testing and clinical trials in previous episodes. 0:12:15.040 --> 0:12:18.880 This is a pretty exhaustive process for good reason. You 0:12:18.920 --> 0:12:21.480 want to make certain that the drug that you are 0:12:21.520 --> 0:12:25.720 developing is efficacious and it is not toxic. Without this process, 0:12:25.760 --> 0:12:28.960 we would be back in the era of patent medicine, right, yes, 0:12:29.000 --> 0:12:31.520 And we'll talk about patent medicine pretty soon too. Patent 0:12:31.520 --> 0:12:37.199 medicine and patented medicines yet more confusing terminology. But that 0:12:37.360 --> 0:12:40.040 is an excellent, excellent point. I mean, we would if 0:12:40.080 --> 0:12:42.920 you go, if you think about it, without that clinical testing, 0:12:43.400 --> 0:12:48.199 you're getting down to, uh, the idea that that a 0:12:48.800 --> 0:12:52.120 company could sell a drug claiming that it has an 0:12:52.120 --> 0:12:55.319 effect without having to prove it or even make certain 0:12:55.360 --> 0:12:58.360 that it isn't it self harmful to people, and we 0:12:58.400 --> 0:13:01.599 don't want that. That's why we have organizations like in 0:13:01.640 --> 0:13:04.040 the US, the Food and Drug Administration to make sure 0:13:04.559 --> 0:13:10.520 that companies are following very specific guidelines to not cause harm. 0:13:10.600 --> 0:13:15.640 So with generic drugs, the testing is a little more 0:13:15.840 --> 0:13:19.640 simple because you've already got a reference drug that is 0:13:19.760 --> 0:13:23.520 chemically identical to the generic drug, at least for the 0:13:23.559 --> 0:13:27.320 active ingredient, So you already know what it does to people, right, Yeah, 0:13:27.360 --> 0:13:30.240 it's already it's already passed through clinical trials before it 0:13:30.240 --> 0:13:32.800 could ever go onto the market. Now that doesn't that 0:13:32.840 --> 0:13:35.000 doesn't mean generic drugs get a free pass and just 0:13:35.040 --> 0:13:37.480 immediately go straight to store shelves, but it does mean 0:13:37.960 --> 0:13:39.960 that a lot of that work has already been done, 0:13:40.040 --> 0:13:44.800 and so the clinical trials are usually smaller and less exhaustive. 0:13:45.080 --> 0:13:48.160 I would say that's probably also a reason why generic 0:13:48.240 --> 0:13:52.920 drugs are cheaper. Well, yeah, because as much to get 0:13:52.960 --> 0:13:54.760 to the stores, right, yeah, I think they can be 0:13:54.800 --> 0:13:57.880 more profitable little at a lower cost. Right, And and 0:13:58.040 --> 0:14:01.199 they're also cheaper because at that point it's a longer monopoly, right, 0:14:01.280 --> 0:14:06.079 you can't. Now, they can undercut, right, they can undercut 0:14:06.120 --> 0:14:10.640 the the the main proprietor of said drug. Well, biosimilars 0:14:10.640 --> 0:14:13.520 are totally different, right, because we've just said a biosimilar 0:14:13.559 --> 0:14:16.480 drug can be completely structured in a different way than 0:14:16.520 --> 0:14:19.880 it's reference drug. Um it's supposed to do the same 0:14:19.920 --> 0:14:24.240 thing pharmacologically, but structurally it could be very different. Because 0:14:24.240 --> 0:14:27.400 it could be very different, then there's the question of well, 0:14:27.600 --> 0:14:31.120 will this have different symptoms, will be have a different 0:14:31.120 --> 0:14:34.600 toxicity level than say, the reference drug does. It has 0:14:34.640 --> 0:14:39.080 to undergo much more extensive clinical trials than generics tend to. 0:14:39.640 --> 0:14:43.440 So that is another reason why the cost difference between 0:14:43.440 --> 0:14:46.840 a biosimilar drug and the reference drug may not be 0:14:46.920 --> 0:14:51.200 as great as you would see in generic drugs, because 0:14:51.240 --> 0:14:54.160 you still have to undergo this incredibly exhaustive testing for 0:14:54.200 --> 0:14:57.080 good reason. I'm not I'm not suggesting that that's a 0:14:57.120 --> 0:14:59.640 bad idea. Sure, yeah, yeah, but but the but the 0:14:59.640 --> 0:15:02.440 market is still in play. You'll still have the effect 0:15:02.520 --> 0:15:06.600 of um of companies attempting to undercut each other's prices. Right, 0:15:06.600 --> 0:15:09.040 The question is just how far lower can they go? 0:15:09.480 --> 0:15:13.600 Considering the fact that the UM the investment in biosimilars 0:15:13.680 --> 0:15:16.960 is generally speaking higher than it is to go into 0:15:16.960 --> 0:15:19.720 the business of designing generic drugs, or not designing but 0:15:19.800 --> 0:15:23.480 producing generic drugs. So let's let's talk about this idea 0:15:23.480 --> 0:15:26.880 of copyrights and patents because it does play directly into 0:15:28.000 --> 0:15:31.280 generics and biosimilars. It's not all science and technology, it's 0:15:31.320 --> 0:15:35.520 also economics and intellectual property. Um. So when you start 0:15:35.560 --> 0:15:39.320 looking at large scale drug manufacturing, you have to go 0:15:39.800 --> 0:15:42.560 all the way back to the Revolutionary War here in 0:15:42.560 --> 0:15:46.880 the United States. That's when uh Andrew Craiggie begin established 0:15:46.880 --> 0:15:49.480 a manufacturing facility in Pennsylvania and he became the first 0:15:49.560 --> 0:15:55.480 Apothecary General of the United States. General. We don't have 0:15:55.520 --> 0:15:59.040 one of those anymore, we know he's entitled though. Yeah 0:15:59.080 --> 0:16:01.640 we got got rid of got rid of that shortly 0:16:01.680 --> 0:16:06.920 after the Alchemist General. Um. But so by seventeen inventors 0:16:06.960 --> 0:16:09.440 were starting to file patents in the United States for 0:16:09.520 --> 0:16:14.120 medical devices and medicines. By the mid eighteen hundreds, companies 0:16:14.120 --> 0:16:18.240 began to form around new manufacturing practices, which at the 0:16:18.240 --> 0:16:21.479 time that was actually more important than the medicines themselves. 0:16:21.560 --> 0:16:25.680 The way you manufactured them became much more important than 0:16:25.760 --> 0:16:28.600 whatever it was you were making uh. And the reason 0:16:28.720 --> 0:16:31.760 for that is that in the United States we were 0:16:31.800 --> 0:16:34.720 really dependent upon other parts of the world to actually 0:16:35.800 --> 0:16:41.040 research and develop medicines. Then what would happen is those entities, 0:16:41.120 --> 0:16:45.760 mostly in Europe, would essentially license the medicines into the 0:16:45.840 --> 0:16:49.200 United States where we could produce them here, but it 0:16:49.240 --> 0:16:51.960 was because somewhere else that's where that's where they were 0:16:51.960 --> 0:16:55.680 being developed. So it was like an interesting thing to 0:16:55.720 --> 0:16:58.640 look at that that we weren't really developing drugs in 0:16:58.680 --> 0:17:02.000 the US at that time, we were simply producing them 0:17:02.000 --> 0:17:05.080 based upon the work people in Europe were doing. So 0:17:05.320 --> 0:17:08.640 that actually became a bit of a problem because well 0:17:08.680 --> 0:17:12.080 by the end of the nineteenth century, German manufacturers were 0:17:12.119 --> 0:17:14.840 holding most of the patents around major medicines in the 0:17:14.920 --> 0:17:18.040 United States UM and in fact, there were subsidiary companies 0:17:18.080 --> 0:17:21.199 in the U S subsidiaries of those German companies that 0:17:21.240 --> 0:17:23.239 were producing the drugs here in the US, and they 0:17:23.280 --> 0:17:26.640 didn't have the full recipe. Like it's like you would 0:17:26.680 --> 0:17:30.440 get a jar with you know ingredient X, and then 0:17:30.480 --> 0:17:32.520 you would you would go ahead and do the mixture 0:17:32.600 --> 0:17:37.640 as right, but you didn't know what was in ingredient X. Um, 0:17:37.720 --> 0:17:39.280 so it was kind of interesting that it was being 0:17:39.359 --> 0:17:42.200 kept as a sort of a trade secret, so even 0:17:42.200 --> 0:17:44.440 though it was being produced in the US, people in 0:17:44.480 --> 0:17:46.240 the U s didn't know what was going into it. 0:17:46.720 --> 0:17:49.840 But okay, so we're we're coming out of the eighteen 0:17:49.920 --> 0:17:53.480 hundreds going into the nineteen hundreds, and lots of these 0:17:53.480 --> 0:17:57.240 companies were from Germany. Yeah. Yeah, so you're you're you're 0:17:57.280 --> 0:18:01.040 getting your you're thinking about like what have ends around oh, 0:18:01.160 --> 0:18:04.280 nineteen fourteen too, that you know, are somewhere around that 0:18:04.440 --> 0:18:07.040 range where you know, some conflict is happening in Europe. 0:18:07.080 --> 0:18:09.440 They they're entering into a you know, the war to 0:18:09.600 --> 0:18:12.760 end all wars. Yeah, except you know, of course it 0:18:12.760 --> 0:18:16.600 didn't end all wars so much so that no one 0:18:16.680 --> 0:18:18.879 at the time called it World War One because they 0:18:18.880 --> 0:18:23.560 were all very optimistic. Um though, at any rate, world 0:18:23.600 --> 0:18:28.600 War one happens, and because it happens, it ends up 0:18:28.680 --> 0:18:32.240 creating a problem where the US is not able to 0:18:32.320 --> 0:18:37.400 access those drugs, those medicines that were coming from Germany anymore. 0:18:38.200 --> 0:18:41.080 The United States was trying to find ways to make 0:18:41.160 --> 0:18:46.080 certain that it wasn't providing financial support to Germany during 0:18:46.119 --> 0:18:48.400 World War One. Sure, I'm sure that also some trade 0:18:48.440 --> 0:18:50.920 routes were a little bit disrupted by by the little 0:18:51.000 --> 0:18:53.840 bit seating. Yeah, so there was actually a lot past 0:18:54.080 --> 0:18:59.920 that that basically let Americans get around this, this entire thing. Yeah. Yeah, 0:19:00.160 --> 0:19:02.040 you get to a point where you're like, well, how 0:19:02.080 --> 0:19:04.720 do we how do we deliver upon medicines? How do 0:19:04.800 --> 0:19:08.439 we do this in this time of tribulation? What what 0:19:08.520 --> 0:19:11.600 are our options? The United States government in nineteen seventeen 0:19:11.640 --> 0:19:15.119 passes the Trading with the Enemy Act and then actually 0:19:15.119 --> 0:19:17.959 allowed companies to produce products that were otherwise protected by 0:19:17.960 --> 0:19:20.600 patents if those patents were held by individuals or companies 0:19:20.600 --> 0:19:24.040 and enemy states. Its invenient. So right, like, your intellectual 0:19:24.040 --> 0:19:26.919 property doesn't count if you are at war with the 0:19:27.040 --> 0:19:31.800 United States and such a fascinating precedent. I love that. Yeah, 0:19:31.800 --> 0:19:34.520 it's It's also the way I live my life. When 0:19:34.560 --> 0:19:36.600 I get into a spat with somebody, I'm just like, well, 0:19:36.600 --> 0:19:39.919 their ideas are no longer relevance, and I can I 0:19:39.960 --> 0:19:44.639 can take whatever they had. Well, now, so does this 0:19:44.720 --> 0:19:49.000 also mean that if somebody like physically assaults you, you 0:19:49.040 --> 0:19:57.360 can plagiarize their novel? I mean, that's how princip If 0:19:57.400 --> 0:19:59.600 that's accurate then I'm gonna I'm gonna go to go 0:19:59.600 --> 0:20:01.720 out to the writer events and like just start picking 0:20:01.760 --> 0:20:03.760 fights with people. So like, oh man, what are you 0:20:03.760 --> 0:20:05.920 gonna do? Punch me, I'm gonna steal your short story. 0:20:06.080 --> 0:20:07.560 I think you're gonna need to be a little more 0:20:07.600 --> 0:20:10.720 specific with your wording because technically you can do that. 0:20:11.200 --> 0:20:15.320 You just can't get away. Uh. Yeah, you can't get 0:20:15.320 --> 0:20:18.160 away with it. But you you you could physically do 0:20:18.240 --> 0:20:22.440 that thing. Um. So we get through World War One, uh, 0:20:22.560 --> 0:20:25.840 and then we started getting into a new thought process 0:20:25.840 --> 0:20:28.400 in the United States. And this is what allows generic 0:20:28.520 --> 0:20:31.720 drugs to really become a thing. Back in the nineteen twenties. 0:20:32.320 --> 0:20:35.800 It's a little company called Bayer, going back to aspirin. Uh. 0:20:35.880 --> 0:20:37.760 They were writing high on the headaches of the world, 0:20:38.040 --> 0:20:41.479 selling aspirate to whomever was ailing. But then you've got 0:20:41.520 --> 0:20:45.120 a lot of companies that were producing copycats. They essentially, 0:20:45.720 --> 0:20:48.520 you know, we're creating their own and we're making their own. Yeah, 0:20:48.680 --> 0:20:51.720 they're just making their own. Uh. Aspirin essentially or asked 0:20:51.800 --> 0:20:56.320 generic aspirin um and Bayer ended up going into litigious 0:20:56.320 --> 0:20:59.879 actions suing lots of different companies and individuals. The courts 0:21:00.040 --> 0:21:02.919 in the United States, however, decide the Bayar couldn't demand 0:21:03.080 --> 0:21:05.719 stores to remove generic versions of aspirant to prevent them 0:21:05.760 --> 0:21:08.640 from being made or prevent them from being made. Rather, 0:21:09.280 --> 0:21:11.720 so then you get to the Second World War, and 0:21:11.760 --> 0:21:15.160 that also reinforced this idea that the United States really 0:21:15.200 --> 0:21:18.520 needed to invest in research and development of its own 0:21:18.920 --> 0:21:21.200 as far as medicines are concerned. It could no longer 0:21:21.280 --> 0:21:27.000 depend upon outside sources to develop this medication. So they 0:21:27.040 --> 0:21:29.840 started to really, uh we see see a kind of 0:21:29.880 --> 0:21:35.479 a a boom in the pharmacological industry here in the 0:21:35.600 --> 0:21:39.159 US post World War two. Yeah, yeah, we all realized 0:21:39.200 --> 0:21:41.920 it was it's it's a national resource. It's it's important 0:21:41.920 --> 0:21:44.520 to be able to be able to fix our our populace. 0:21:44.720 --> 0:21:47.320 It's it's it was. It was essentially a type of 0:21:47.400 --> 0:21:50.720 national security, right, just like just like we talked about 0:21:50.840 --> 0:21:54.960 fuel in terms of national security today, medicine certainly fell 0:21:55.000 --> 0:21:58.600 into that same category. Um. And you often will hear 0:21:59.000 --> 0:22:02.439 arguments similar to the US today about companies that develop 0:22:02.520 --> 0:22:05.480 a drug and of course they will protect that drug, 0:22:05.920 --> 0:22:09.680 and for the duration of that protection they can charge 0:22:09.680 --> 0:22:11.640 pretty much whatever they like, and there's not really any 0:22:11.680 --> 0:22:14.240 alternative to it. And you talk about things like, well 0:22:14.240 --> 0:22:18.320 that that seems really predatory. Well, during post World War 0:22:18.359 --> 0:22:21.800 two era, we were attempting to avoid a global version 0:22:21.840 --> 0:22:24.720 of that. We still have the corporate version of that. 0:22:25.200 --> 0:22:29.560 So then you get into the idea of patents. Uh, 0:22:30.400 --> 0:22:32.919 now this we brought this up earlier, Joe. You mentioned 0:22:32.960 --> 0:22:37.960 patent medicine. Patent medicine ironically counterintuitive name, Yeah, ironically it 0:22:38.040 --> 0:22:40.800 doesn't have a patent. A patent medicine is usually what 0:22:40.840 --> 0:22:43.359 we call. You know, you had a snake oil sales 0:22:43.480 --> 0:22:46.040 and running around with a cart full of bottles of 0:22:46.119 --> 0:22:51.920 something called like you know, Uncle Uncle Jimmy's Cure Everything juice, 0:22:52.200 --> 0:22:57.560 And I always think of a rheumatism, diarrhea and cancer. Yeah, 0:22:57.560 --> 0:23:00.320 fix it all and who turns out? What's in it 0:23:00.359 --> 0:23:05.280 is usually like alcohol and some turpentine or something. It 0:23:05.320 --> 0:23:08.120 always it always makes me think of a Doc Terminus 0:23:08.160 --> 0:23:12.240 from the movie Pete's Dragon, Uh, played by Jim Dale, 0:23:12.520 --> 0:23:16.560 an amazing Disney villain anyway, so he's not in the 0:23:16.920 --> 0:23:20.560 new one. I digress. I was on a Disney cruise, 0:23:20.560 --> 0:23:24.400