Are you a professional pillow fighter or a 9-to-5 low-cost time travel agent? Or maybe real estate sales on Mars is your profession? It doesn't matter. Whatever it is you do, however complex or intricate, monday.com can help you organize, work a straight, and make it more efficient. monday.com is the one centralized platform for everything work related. And with monday.com, work is just easier. monday.com for whatever you run. GoodaMonday.com to learn more. Hello everybody, this is Marshall Pillow. I'm the editor of the New Books Network. I want to tell you about a new book, Public Success Private Grief, an extraordinary personal account by Peter Cowley. It's about Peter's life of professional accomplishments alongside extreme personal tragedies, cancer, suicides among his closest family members, and alcoholism. Peter spoke about public success private grief on the NBN recently. Alas, Peter has been diagnosed with cancer and I urge you to read this compelling book. It's open, honest, and filled with life lessons. Visit ps-pg.com to learn more and buy the book. Hello everybody, this is Marshall Pillow. I'm the editor of the New Books Network. And I'd like to tell you that we have a new and improved website. It has two new features that we think you'll love. One of them is a vastly improved search engine so that when you type in keywords, you'll get a bunch of episodes really quick. The other is the ability to create a listener account. And in that listener account, you can save episodes for later listening. So you can create a kind of listening list. We think these features are neat and we think you'll enjoy them. Please visit the site today. Hi, I'm Dr. Robert Pearl, former CEO of the Permanente Medical Group, Kaiser Permanente, a Stanford Medical and Business School professor, a Forbes contributor and bestselling author of the book Mistreated, while we think we're getting good healthcare and why we're usually wrong. And I am Jeremy Kor, host of the New Books and Medicine podcast. American healthcare is broken. Across the United States, there are over 200,000 patient deaths from medical error every year, growing physician burnout, outdated technology, and inconvenient and delayed care for patients. And on top of all of this, skyrocketing drug prices and increasingly unaffordable out-of-pocket patient expenses. For decades, our nation's political and medical leaders have talked about fixing the American healthcare system. And yet, the problems are now greater than in the past. Every other industry that is inefficient and ineffective has experienced disruption. Healthcare will be no different. The question is whether the solutions will come from inside the healthcare system or be imposed on it. We'd like to invite you to listen to our new podcast, Fixing Healthcare with Dr. Robert Pearl and Jeremy Kor. Each episode will feature one of the top leaders and innovative thinkers in healthcare today. This show's format is simple. The guests will present their roadmap for fixing American healthcare's biggest problems. And from there, Jeremy and I will scrutinize the plan and help listeners separate, fixes that are the potential to succeed from simply the hype. Our goal is that everyone from healthcare consumers to political and medical leaders will find value in the discussions on our show. You may not agree with the different solutions offered, but you will never again conclude that nothing can be done. We hope you will join us. Please subscribe via iTunes or your favorite podcast software. For more information, visit our website at www.fixinghealthcarepodcast.com. Hey everyone, this is Mikey McGovern, and you're listening to new books in medicine. Last week, I have a chance to catch up with Jeremy Green at the History of Science Society meeting in Chicago to discuss his new book, generic, The Unbranding of Modern Medicine, published this past August by Johns Hopkins University Press. Generic takes readers in a whirlwind trip through the making of the modern pharmaceutical industry, viewed through the lens of generic drugs, which were a crucial note in a sprawling web of efforts to rationalize therapeutics in the beginning of the 20th century and onward. We tend to associate generic drugs with the ability to choose between specific chemical agents, a strip of any branding that would differentiate between them. Yet, the history of generic medicines reveals a highly politicized arena in which the very idea of chemical and physiological similarity was hotly contested and questioned at such for the first time. As Jeremy shows us, generics were rife with controversy when they were first introduced because they challenged the existing practice of branding as assurance of quality. By boldly asking if there is really any such thing as a generic drug, Jeremy inverts preconceived notions about the use of chemical names to rationalize the pharmaceutical marketplace, revealing that like all products, they were socially, politically, and economically constructed. On the whole, it's a fascinating book that calibrates the history of modern medicine with consumer and legal history, as well as the history of technology more generally. The poignant narratives and vibrant marketing paraphernalia used to weave together the big picture of generic drugs in the U.S. are sure to entertain and stimulate the thoughts of many audiences. Along with the next book I'll be discussing, Joe Gabriel's Medical Monopoly, generic is a remarkable entry in a growing field of pharmaceutical studies that only becomes more important as the issue of healthcare provision dominates presidential agendas and holds a prominent spot in the public sphere of debate. I urge you to go out and read these books in order to gain a richer appreciation of the legacy of these issues. All right, hello, everyone. This is Mikey McGovern with new books in medicine, coming at you today from the history of science, society meeting in Chicago, Illinois. And I'm here with Jeremy Green today to talk about his new book, generic. So Jeremy is a professor of the history of medicine and of medicine at Johns Hopkins University. And in addition to maintaining scholarly practice, Jeremy is also a clinician still, correct me if I'm wrong. Yes, no, I see patients once a week at the East Baltimore Medical Center, which is a fascinating and complex urban health center in East Baltimore. So in many ways, the clinic is a site of ethnographic engagement where one is constantly struck by the social dimensions that constrain access to care and the nature of the categories we use in contemporary medicine. That actually relates to something I wanted to ask you about a bit later. Sure. But so, and then, you know, so Jeremy's written two books, actually this book, generic is a second. The first book prescribing by numbers was sort of about the, and I guess really the co-construction of both medicines and health conditions. So sort of looking at the interplay between how we think about, you know, human health and its measurement and the actual marketing and existence of pharmaceuticals. But this book turns its attention toward the market for generic drugs and sort of takes us through a history that is both a labor history, a legal history, and a scientific history. So there's so many aspects that are fascinating about this and from the perspectives of consumerism and also from just, you know, even, you know, those basic philosophical questions that inform a lot of good history of science, right? What does it mean to say that two substances are equivalent? So I'm really excited to be talking more about the book today. Jeremy, and yeah, welcome. Well, thanks, Michael. It's really a pleasure to be able to take part in this. And I'm so glad that you enjoyed reading the book. It was a pleasure to write. It took about 10 years. As you mentioned, it took me through a lot of new and unfamiliar terrain, both in terms of some basic existential epistemological questions about how we know what we know in medicine. But through a lot of other areas in which I had to develop, so it's not expertiously some new familiarity and legal studies and business history in consumer history in different forms of regulatory politics. And this is one of the strengths I see of this, I guess I could call it an emerging field of pharmaceutical studies. What happens when you take an object like a drug and use it to tie together or to meander across a number of different disciplines and a number of different forms of social life that inform the way that science governance and practice of every life come together in American society. So it's hard to pin down exactly what the genre of the book is, but it did throw out of the first project prescribing by numbers. And in a way, as historians, in order to convince ourselves that we don't just write stories of the way that we would like to see the world, to move beyond a path analysis, we always look for things that push back and surprise us, things that we find in the archive in literatures that we didn't expect that give us this hint that there is some empirical work being done, something of the research that pushes back against our interpretations. And for me, the book, as a whole, rose out of one of these observations when I was doing the research for prescribing by numbers. This first book is really about how drugs, especially over the last 50 years, have emerged as powerful mediating forces in the way we defined disease. And I was particularly interested in how we define this emerging category of asymptomatic diseases that don't have patients with symptoms, that just have numbers of thresholds that can be defined and redefined and lowered. And every time they are lowered and attached to guidelines that involve hundreds of thousands of physicians and millions of patients newly consuming drugs with a stroke of a pen. I became really interested in the role of marketing and how the pharmaceutical markets interacted with medical research, the production and circulation of medical knowledge. One of the things that I guess was an assumption I carried into the book project initially is that this is all the work of brand name drugs. Right. And that generic drugs did not suffer from this problem. Generic drugs somehow represented the generic name, denoted to chemical, generic drugs had things like pharmacokinetic, pharmacodynamic, true scientific properties, whereas the brand name drug was this label plastered on top of the underlying meaning. And that the distance between brands and generic was an inflated price, or in many ways like the distance between Marx's concept of use value and exchange value. Right, right. And that the generic was the true medicine, and the brand name was symbolic of all of these problems that we have in American medicine and the commodification of care. But as I did the research for that book, I began to realize that it didn't really work out that way in a number of ways. On the one hand, brand names and generics were not always exact at the same thing. And pinning down what it meant to be the same thing was more than just a marketing smokescreen on the part of brand name companies to distance themselves and create an incommensurability compared to generic products. There were real forms of difference. The question really became, did those differences matter? And who got to decide what forms of difference matter? So somewhere in that observation, it was thought that warmed around inside me for a while and led through a number of fascinating archival finds. Yeah, and that's another thing I wanted to ask you about is, you know, you say in the acknowledgments that you had to work pretty closely with people at the FDA using the Freedom of Information Act to actually get access to some of this, because it's a wealth of material. And a lot of people in health studies really do, of course, want to see what goes on in these and certain legal proceedings and see what goes on in these firms in the first place. It's such a veil overall of it really because of information security on their part. But it's really fascinating what you were able to uncover. What was that process like? So the process actually isn't that difficult. It's just a bit of a craption. You don't know exactly what you're going to find with FOIA, with Freedom of Information Act. Right. A lot of paperwork as well. There's a lot of paperwork. There are some very helpful people at the FDA that want these resources to be more available. And I would really recommend for any researchers interested in this question that John Swan and Suzanne White-Cunard of the History Office of the Food and Drug Administration are really invaluable resources in guiding through this process. But essentially, you submit a request and you have to have a hunch that the kind of thing you're looking for exists. So one of the things that helped me was noticing that a few researchers before me, typically Harry Marks, who is actually my precursor in the cherry currently hole that John Hopkins, Harry had found access to a group of files called AF jackets. And these jackets, when you started looking at them, contain the correspondence between the Food and Drug Administration and firms. And if you can identify a group of firms, and for me, the question was looking back and saying, well, when did the generic drug industry emerge? What were the early firms? That is one cast a wide net to find a number of different players that may have been involved in the forming industry. And it was a bit tough because the generic drug industry is somewhat of a self-effacing industry. At least it was until perhaps the last decade when it's been incredibly prominent. So I managed to cast a wide net and what came back in were just boxes and boxes worth of correspondence with firms that represented such different ways of being a drug company. And I guess if I can extend on that for a moment, one of the insights that surprised me initially is that there is no generic generic drug company, but there are many different ways of trying to make and sell the same thing. And when you think about generic drugs, I think a lot of commentators on the industry over the years just assume the generic drug companies only compete on price alone. So whoever can make the cheapest drug wins. But that's actually not the case at all. There's all this rich form of differentiation of different kinds of claims of similarity. So some of these early firms were what would have been called ethical firms in the late 19th century, the differentiate themselves from patent drug makers, but ethical firms that didn't succeed in the way that the Merck's and Pfizer's and up John's the world succeeded in developing research and development labs. Some ethical drug firms just continue to sell the same drugs. And after a while, they begin to realize that what they were selling didn't have value in terms of these innovative new drugs. But by the second half of the 20th century, especially in the 60s, this Medicare and Medicaid indicated increased governmental involvement in paying for drugs that by claiming to make the same thing cheaper, they could actually market a new form of value for themselves. Other companies just joined them, there's a company called the COT COLA Corporation after the passage of Medicare and Medicaid created a new subdivision called Medicare that would make generic drugs. But of course, this is from a company that only had experience making soft drinks at that point. And one of my favorite companies is called BOLAR, which was founded by Robert Schulman and Larry Ricefeld. That was a really interesting story in the book actually. So as you remember, it's Bob and Larry form firms, it's the Bob and Larry firms real company that becomes BOLAR. And BOLAR becomes a fascinating and just following after he's taking this very intransigent company that has almost no knowledge of how to apply for permission to market a drug at all, gradually get roped into a regulatory framework and to the point of becoming a legitimate generic drug manufacturer. Right, because they sort of play this game of sort of ignorance about the kind of legal strictures around this. And because they're just trying to innovate to the cheaper ways to manufacture these drugs, right? And so they see that as their work as sort of being creative tinkerers. But in fact, that doesn't really mesh with, well, I guess then still sort of nascent regulatory framework around competing types of generic drugs I'm correct. No, I think it's a very good way to frame it. But here you have a market space that emerges with a number of different entrepreneurs finding their way in and making that market space around them. And one of the things I've realized is most historians of medicine's extent that we think about generic drugs, assume them as somewhat of a naturalistic part of a life course, a very structuralized life course of a drug. You know, you have this rat protected era and then the patent expires and then the invisible hand does its magic and all of these competitors are just making cheaper products. And we accept that even as we are critical of other things, we accept this as somehow being a naturalized way of understanding drugs. But that's actually an entirely historically specific construct that really is only valid beginning in the middle of the 20th century, if it ever really is. And so we realize that we've assumed the generic drug industry to be something other than a private sector. It's often valorized and moralized as a moral industry as opposed to an immoral big pharma. You have this moralized, you know, valiant little pharma that helps serve the health of the public. But when you open up and take a look at it, the generic drug industry is neither moral nor immoral. It's a moral. It's as amoral as any other pharmaceutical firm. And trying to understand how in that amoral space these different, very different marketing practices and production practices take shape is I think one of the goals of the book. Yeah, absolutely. I think it's, and it is really interesting what you're able to do with at least those are just focusing in on the all the contingencies of the moment and how, you know, very practical sorts of actions do leave downstream to consequences and public perceptions of these things. Like you say, this construction of, you know, the immoral, big pharma, and then the moral little guys producing generics that everyone can access. But then even before, so even before then, I kind of want to dial back to kind of earlier in the book, when you're, you're talking about essentially, so this, this, we have this idea that if we can, or perhaps it's somewhat circulating that if a drug is cheaper, there are scientific ways to test clearly and demarcate between different substances and qualities. And that, you know, we sort of see the cheapness of drugs as this sort of, as imbued with an ethic of universality and access. But I mean, back when some of these upstart firms, I think this is back in the 1940s, back when some of these upstart firms began sort of marketing anonymous drugs, there was a huge public backlash against these drugs because the only way the public had to identify with the sort of, I guess, efficacy and even, you know, legitimacy of a medicine was to have trust in the brand name. So there was really a lot of, a lot of public backlash against these sort of, these early players. So could you, can you take us back into that for a bit? Sure. So, and it's a large question because in, in a sense, there are imitative products and markets for imitative products in medicine well before the mid 20th century. And one book, which I think is a nice job opening up these questions in the 19th century is just recently released a book called Medical Monopoly by Joe Gabriel, one of my upcoming interviews. Great. No, and I think these two books are actually, they read very well together. In some ways, this book takes up where, where, where Gabriel's book leaves off. But just to say that there's a longer history of imitative medicines. And one of the things that both Joe Gabriel and I trace in our books is this tension between public and private standards of value and efficacy and safety and quality in medicines. And of course, there's a public standard that is even in its own origin, a private standard, which is the United States pharmacopeia. And the United States pharmacopeia really is, it's a book that ties words to things, right? How do you know that this, what it says on the label is in the bottle. If you open up the pharmacopeia, you can look for an entry, a acetyl salicylic acid or a diacetyl morphine. And the pharmacopeia will give you the chemical structure. It will give you proofs, like, tests you can do with available reagents to make sure the chemical is what it claims to be. It's a computer in your book. It's so nice that you actually, you're able to make these visible to people to sort of see, okay, it's actually tested in certain drugs. You're sort of just generally relying upon trained eye to see exactly when, say, after adding so much iodine, something does turn black or brown or yellow. So it's really quite a passive process, isn't it? Well, and the pharmacopeia, you know, can be traced back centuries. It's really, it's an early modern construction. What becomes interesting to me in the 20th century is the kind of added weight and responsibilities the pharmacopeia takes on. So in 1820, the first United States pharmacopeia convention gathers, the meetings are held in Congress physically. Although it's a private entity, it's really physicians, pharmaceutical manufacturers and pharmacists coming together to define these standards and publish their first volume of how do you know when a drug is a drug. And yet, at the same time that pharmaceutical companies are coming together to help define these public standards, individual firms, especially as they grow over the 19th and then the early 20th century, have a stake in defining a separate space for their private standards that, well, sure, on some level, all morphine is morphine, but our morphine is held to a higher standard of quality. There's ads of Hebrew and national, in the late 20th, early 21st century, that we answer to a higher authority. In essence, some aspect of this is crucial to pharmaceutical manufacturing, manufacturing. Most ethical pharmaceutical manufacturers are selling the same drugs. They're not based on patent monopolies, right? And so different firms differentiate themselves in the base of quality. Jonathan Liebenau has discussed this a bit in his history of the American pharmaceutical industry, that when you see science entering the American pharmaceutical industry in a laboratory becoming useful, in its earliest ages, it's really as a means of selling drugs that he calls a scientific marketing. So Park Davis can claim that they have an analytical laboratory that can guarantee that the dosimetry of their ergot preparations is superior to any other ergot preparation. Sure, other companies make ergot, ergot is ergot, but our ergot is delivered at a level of quality and dosimetry that is proven by exacting scientific measurements. And that's why you should trust us more. Right. So in a way, claims about quality are reliant upon existing sets of standards and sort of modifications of claims about how they other uphold or exceed standards, right? Exactly. And here, this is this fascinating tension between public and private standards. This reminds me of some very important work that's taken place in the field of history of technology over the past 10 years or so, particularly the work of Amy Slaton, who has written a very nice piece on the politics of what it makes it to call something as near as practicable, as learned as engineers, as people working in industry come together to form public standards. They don't want to work themselves out of the job. So there's always a little bit of space left. And then the pharmaceutical industry, that space, is occupied by something that becomes referred to as pharmaceutical know-how. And you see this play out in the brand versus generic debates in the mid-20th century, that brand-name pharmaceutical firms will say, yes, we acknowledge that the chemical is the important part of the drug and that generic drugs have the same chemical as our brand-name drugs do. But the chemical is not all that a drug is. When you purchase a drug, you purchase a sophisticated technology that delivers that chemical or it needs to be in your body. And the quality of all kinds of different dimensions of how that pill or tablet is manufactured affects how it actually works as a product. So this concept that it's not enough to just have the public standards. You have to also have the pharmaceutical know-how to deliver them into meaningful product. There's this tension between public and private. But you are right, though, and that in the mid-20th century, many physicians, many consumers, are taught that they really can only trust private standards of quality, that public standards are sufficient to help you know you're getting a given chemical. They're not enough to know you're getting the drug that will work for you. And I think one of my favorite illustrations of that in your book is I believe this was with the drug chloromycetin, but you talk about how there was a pet shop owner who used to treat his fish tanks chloromycetin, it would always dissolve within about a minute or so. And so upon buying the new generic version, he was very excited that he was going to be able to buy the same drug for cheaper and drops in his fish tank. And still hours later, it just hasn't dissolved because it's made using a different filler. So it's the exact same substance, but the kind of excitencies the manufacturing and packaging of that substance make it such that it acts entirely differently. So I thought that was a really nice illustration, I'm sure they're countless more. Well, the chloromycetin example is a very important one. And again, a story that one can trace your number of different kinds of archival sources and congressional hearings, and clinical literatures. But one of the things to recapture in the story is that a chloromycetin, which in generically termed as chloramphenical, was Park Davis's blockbuster drug at the moment in time, a huge percentage of their annual revenue came through this one drug. And as its patent expert neared, not only Park Davis's employees, but the business community at large, the business pages of newspapers and magazines began to write speculatively what is going to happen when this drug goes off patent. And this is a genre of reporting that we now know. It's a very common genre. It's like the patent cliff. When Lipitor was, when Pfizer was about to lose his patent on Lipitor in 2011, there was, there's so much anticipatory reporting on this, but that's the reporting that happened. This is the first time I've really seen such a large visible attention to national press on a drug going generic and the problems that would emerge there. And as you mentioned, one of the, one of the, to Park Davis's great fortune, one of the manufacturers of a generic version used starch as a filler in the pill, even though it had the same amount of chloramphenical. And this fish fancier found the scum floating on top and told the Park Davis salesman, Park Davis made a lot of hay with that. It led to studies being done on volunteers. And we'll volunteer some quotations here, many of these volunteers were prisoners. But, and one of these studies found that you could take a generic version of this antibiotics, very important life or death drug, and who contained exactity in that antibiotic, swallow it, and it would come out the other end, completely unresolved. And so, this illustration of the difference between chemical equivalence, you could have a chemically equivalent drug that was completely therapeutic, but useful, really cracked open this problem of brand and generic exchangeability in entirely new life by the late 1960s. Right. And then that sort of forgot its own scientific field of study, so that you look at the emergence of a little bit of pharmacokinetics, and also look at how, you know, biological equivalence is studied through, through testing on animals. And this, you know, essentially ways to try to standardize effects, because, obviously, for therapeutics, at one level, there's the quality control on the part of the firms to, you know, ensure that something they're making is kind of the pure. But, there's also, then you get new regimes of quality control, and also regimes of regulation from external bodies and needs to sort of demonstrate sufficient proof to the FDA, and also to the public. So, and that sort of begets what you call more the sciences of similarity, you know, I guess, in a different, in a sort of different register than they were previously. No, thanks for bringing that up. Part of what drew me to the subject is recognizing that the field of history of medicine have engaged very closely the emergence of science of difference, sciences of racialized different, sciences of gender and sex differences, and ways in which different, different regimes and different epistemological moments in social and political contexts have given rise to different kinds of determinisms, but that there was an equally important study of the science of similarity that I thought our fields had not really tended to play this much. And one of the things one finds looking at generic drugs, again generic drugs are commodities, in some ways they're one of the most commodified parts of the medical realm. And I structured the book to think about how we can think about commodities. The first section is really about production. Where does a generic name come from? Where does the generic industry come from? How do we begin making these things that can do the same? The middle, the last part of the book is about consumption. The middle part is really about circulation. And in my mind, these sciences of similarity form a key set of protocols that allow us to begin to have confidence or create modes of governance to invest these objects with fungibility, exchangeability, and the ability to move back and forth and say that they are actually functionally the same, which is key to how the generic market works. But again, one thing that surprised me and pushed back is that there was no one moment in which a science of generic similarity emerged, that there were actually many sciences. And part of the problem of studying the nature of the generic is that these are regimes not of identicality, but of similarity, right? And as we study similarity, we realize, well, what does it mean to be similar? Well, it means to be the same in all ways that matter. And yet knowing what ways matter quickly opens up these rumsfeldian questions of, you know, known, knowns, known, unknowns, and unknowns, right? And, you know, it's just to make an analogy. If we think about how the field of organic chemistry has developed over time and try to figure out what compounds are the same, and you know they're the same, you know, you can look towards a moment in the 19th century where the formula seemed to be the most important way of designating a compound, and how many carbons, how many hydrants, and the oxygens. And it's only with the demonstration of the importance of structure, right, in that you can actually have two molecules with the same amount of, you know, think of a detinker toy set where the same balls and sticks, and yet even if you put them together differently, they have different boiling points and melting points. And yet even this concept of isomerism, it's later on fractured open on new forms of different, so we call optical isomerism renantiomers. If you have a left-handed or a right-handed form of the same structure, if you look at it in a mirror, these two molecules love the same boiling points and melting points, but they may have a very different pharmacological function. A left-handed form could be a poise in the right and a form could be a cure. So, right, I know chemical analogies aren't necessarily the most accessible analogies, but in my mind, this illustrates this process of how everything is the same, can be considered to be the same until we find new forms of difference that we haven't attended to before that matter. In a way, the whole illustration of chloromycedae is an example of this chemical equivalence is sufficient until the point where it isn't. And then biological equivalence becomes important. But as you're mentioning, biological equivalence or bioequivalence is also not in itself sufficient to handle all claims of possible generic difference quality controls, different forms of marketing, increasingly epidemiology of drug experience over time, generate new sciences of how we call things the same or different. Right, and then even still at the end of the day, some firm can always, or some average hasn't can make the claim, the drug that's tested in this really great illustration of an ad in the book. The drug that's tested is never the one patient actually is imbibing and relying upon. So, there's always this level of potential dropouts of secure identity that basically saturates the entire enterprise, really. It really does. And in a way that becomes, on the one hand, pernicious, but also somewhat intractable. How does one eradicate brand thinking from American medicine is a very, very hard proposition to consider? And again, at the beginning of my study of generics, I viewed it as a problem. The brand is a problem. American health values brands. We commodify medicine. We create these areas of waste. We turn health care right into a good. Studying the generic for me was initially a back door into analyzing the problem of the brand. And yet, as I pursued the study more, I began to realize that the economies don't work out as easily as we want them to. And rather than seeing the generic as a way of unmasking the brand, began to realize that there's a very complex set of interests of those who want to see generics as exchangeable, generic manufacturers, insurers, regulators, some consumer groups. And those who want to see generic and branding drugs as incommensurable pharmaceutical manufacturers and physicians. And rather than see all of the knowledge production at that intersection as just being politically tainted, we realized that it's really forms a fascinating dialectic where you have a thesis and an antithesis. And what emerges of that intersection are these new forms of knowledge making. And as you mentioned before pharmacokinetics, this field of how one studies, how drugs move in different parts of the body is a vital part of how students learn medicine these days. It did not exist prior to the brand sharing. Controversies, you have this generative emergence of new forms of knowledge making that can't be reduced down to one interested form alone that come at the intersection of these powerful interested positions in medicine. And I'm glad you bring up the exchange ability because I thought that one of the other really interesting, you locate a lot of different kinds of contests in different places. But one of the most fascinating and perhaps the most familiar ones is looking at the level of an individual physician prescribing a drug and the pharmacist determining whether or not, if a certain brand or a certain kind of specific generics and then stop, what is actually equivalent and what is actually exchangeable. And this was, I mean, you trace this out in a bunch of different state registers, particularly in New York, I remember correctly. But basically, the idea that certain drugs could be exchanged more readily for another was really a very kind of local thing. I mean, it was always, it was contested at the level of states. And it was mostly contested between certain physicians who felt that their authority was being compromised by pharmacists. And then pharmacists who in their own, they weren't actually through their actions trying to compromise any higher authority or knowledge, they were sort of simply trying to do the best in their practice using available knowledge about what might be equivalent. So there's just so many areas of like slippage between these different sorts of practices. But I'm going to expand a little bit more on exchange ability and how, I mean, how these sort of regimes of exchange became legitimated. Sure. And I, it's a key question of the book. And again, a subject that really opened up in ways that I didn't expect the opposite of my research. One of the things that grew out of studying the science of similarity and these protocols is that they could be determined and contested at the FDA, for example, ultimately, and yet still their implementation to make things exchangeable is not just a matter of producing forms of scientific knowledge that are agreed upon. It also has tied into a complex legal structure, which I refer to as the laws of substitution, right? So how is the legal structure set up to either permit or prohibit exchange? How are financial incentives set up in institutions like government reimbursement and private insurance incentives to help things be substituting for another? And, you know, as you know, in the book, there's a fascinating shift that takes place from a set of laws that are passed throughout the country by the 1950s, which are anti-substitution laws. And these laws emerge because of a political action that is largely supported by a union of pharmaceutical firms and pharmacists and also physicians that want to define brand generic substitution as an unethical and illegal act for pharmaceuticals. And they're successful in almost every state in the country. So by the time generic drugs are growing in popularity among consumer groups and government regulators in the late 60s, early 70s, some state attorney generals are actually advising pharmacists to substitute, even though it's technically illegal, so that Medicaid says that the nations will actually get less expensive drugs. You wind up with this very local set of conflicts about these legal structures. Ultimately, these laws are overturned in all of the states and replaced by pro-substitution laws. But these laws are still very variable. So that in some states, they just allow generic substitution. In others, they mandate it. In some states, substitution happens only if a physician puts a signature of allowing it. In other states, substitution happens unless, like the only reason substitution won't happen is if a physician signs a form, making sure that something doesn't get substituted. So we have this patchwork of state, very, very different state-by-state structures of how generic drugs are utilized to persist this day. We've had a similar heterogeneous landscape of how different insurers promote or incentivize use of generic drugs. And again, somehow you find in here this tension about the concept of substitution. So what is a substitute? Is a substitute this useful functional thing that helps you achieve goals and times of duress? And I make the metaphor for example, a substitute teacher who is not your regular teacher, right? But assuming for at least that they should help be qualified enough to help a high school class, make its way along a certain progress in a curriculum or a substitution of form of deception, such as what happens if you go to a restaurant and order a Coca-Cola and someone serves you an RC-Cola or a Pepsi without asking you if it's explicitly okay for that to happen? And this is these twin phases of substitution is something which helps make a system more functional on the one hand versus a form of deception that can take advantage of the levels and rumors on the other, really persists to this day in legal structures surrounding the problems of generic drug use. As you were talking, I was sort of just thinking about how, you know, these different sort of local and state attitudes toward substitution and the relationship between what the government allows you permissible, the authority of physicians, and what is economically necessary is perhaps one way to begin to look at differences between the states and differences opinions about things like universal health care. You know, what does that mean? The concept is just foreign to most people, probably because, you know, in the US at least, it's always been mediated in such a, you know, local, at least at the state level, sort of way. So, I mean, it's one way to begin to think about, I guess, you know, differences and how legal differences actually manifest themselves in the availability of certain kinds of care and commodities. But that's just interesting. So, we don't have too much time because they're beginning to set up for the session in here, but I did want to ask you a bit more about it. So, the last chapter of the book, you talk about global generics, and actually, it sort of brings things full circle because the book begins with a discussion on nomenclature and how, you know, international attempts to standardize nomenclature so that, you know, the same drug could be, you know, made available during times of war when, you know, let's say physicians were carrying, say, the same American physician is working in France and has to sort of perform some kind of emergency responsibility, how does one request the same exact substance? So, this issue about, you know, sort of the global and translating between different, you know, kinds of pharmaceutical practice and things themselves, right, then becomes full circle at the end when you talk about the marketplace for global generics and how sort of, I mean, you focus mostly on, you know, countries like India that become, you know, major, major manufacturers of generics in such a way that the West becomes highly dependent on, I guess, the, I guess, the differentials between, you know, labor value, right, and how, essentially, in India, because of the, because of both the regulatory policies and the attempts to sort of assert itself in the global scientific marketplace, you get basically a framework where you've got lots and lots and lots of pharmaceutical firms making generic drugs, sometimes we have become huge leaders, but you just get, you know, just a huge multiplication of all of these different firms and then you also have, at the same time, as the same time as more of these substances are available, you also have sort of global politics that decide that things made elsewhere are still not quite equivalent just because they're made elsewhere. So there's one, there's one really evocative story I think you're talking, when you talk about how about like a ship bringing a bunch of big shipment of a few tons of generic from India, like, was it over to the US? It was stopped by, at some point along the way it was stopped by Dutch officials and essentially just sent back as sort of, you know, being like a legal or not properly regulated, but it was actually totally fine. It was just sort of an attempt to use international policing to kind of, you know, keep their, I mean, maintain certain stakes or maintain the market in a certain way, so I just, if you could expand a bit on sort of where you see the global in this project, that would be really cool. Sure, I know, and it's a great set of questions. It is one of the problems of writing a history that ends so close to the present is there's several more chapters I would like to write about that, and it's very hard to stop, and at some point you have to find a stopping point. I would also want to say that although the frame of the global is very important, especially in the very beginning and the end of the book, the book itself is not a global history of generics, and it's very important to understand this is local history itself, so we're talking about the generic industry in the United States, and the reason I think that that's a reasonable thing to do is that generics become important in the United States far earlier than in the other industrialized democracies in Western Europe, because they are a free market solution to a public health problem, and although we tend to think of them as a progressive set of actors and policies, again, they are free market actors, so it's fascinating that the solution to a problem of escalating drug pricing in the United States was never to do say what happened in the UK where you have a central payer from a national health service that can actually argue, negotiate with brand new manufacturers to get reasonable prices, we've never collectively been able to do that in the United States, so instead our way of dealing with actors and drug prices collectively in terms of our public policies was to produce a set of policies that encourage this generic industry space, so it's a private sector solution to the problem of drug prices, and of course generics become important in other parts of the world for very different reasons, so if one was to write a history of generics from the perspective of the India, or a history of generics from the perspective say Pakistan or Sri Lanka, generic policies emerge in very different ways, and Sri Lanka in the 1970s you see the emergence of pro-generic policies that are very much based on a central state in Brazil, similarly you see state manufacturers of generics, there are many different histories of the generic drug that would be told very different places, and a number of anthropologists and historians are beginning to look at these questions, but I think there's some really exciting ways. Now in terms of the frame of the global and what kinds of competition happen there, in terms of the reference towards this piracy and as a problem of ships being forwarded, there are very very important questions of the broader political economy of how who controls generic markets and how and how they are standardized, and the anthropologist Corey Hayden has been doing some fascinating work on this lately, looking at different sites in Latin America, and trying to understand how different ways to sell the same drug in Mexico, for example, or in Brazil have generated these different tiers of where you can pay more for more exacting standards at similarity, and yet it's also locked into legal and political battles over who can claim to be producing the same drug, and many policies taking shape in places like Brazil and Mexico and Argentina are increasingly favoring multinational generic producers, over local generic producers, so even within the generic, again this proliferation of different ways of being a generic company has ramifications that are connected with globalization and very powerful ways today. Yeah, that's fascinating, so just as we wrap up, what are you working on now? So I'm working now on a project on a history of telemedicine, actually, so I'm taking this interest in pharmaceuticals as technologies that invoke powerful ways of understanding how we see the world and how we produce, how do we categorize health and illness, for example, which of course through my first two books, I'm making a bit of a lateral move from pharmaceutical technologies towards communication technology, to become very interested in how it is that there's an attraction and a promise to this idea of doing medicine at a distance, but also a set of anxieties and fears over what is lost and what is jeopardized in that process, which you can see very actively in contemporary debates over electronic medical records and telemedical systems, but if one looks back in the late 19th century, one finds very, very familiar terms of debates about the interaction of the telephone in medicine or the text pager in medicine, and so realizing that there's this whole field of studying the history of communication technologies in medicine that has largely been ignored by our field. I've found some fascinating materials and questions in there. It's a very new and open landscape for me, but it's actually quite fascinating. Wow, that sounds really awesome. I look forward to hearing more about that. Well, anyway, thanks so much for listening and Jeremy, thanks so much for sitting down and talking with me here. We're going to go, we're going to go hear some more talks from other scholars in the history of science, but tune back in in a few weeks or so, and I should have some more interesting talks for you as well, so thanks so much for listening. This is New Books in Medicine. See you. [BLANK_AUDIO]
Is there any such thing as a generic drug? Jeremy A, Greene‘s new book Generic: The Unbranding of Modern Medicine (Johns Hopkins University Press, 2014) treats its subject matter with a learned skepticism that lets the reader see through the eyes of the historical actors who helped define the modern drug industry. By inverting preconceived notions about what we take to be mundane, mass-produced chemical identities, the book offers a broad yet pointed glance at an industry and its attendant regulatory structures that developed alongside modern consumer culture. Claims about the equivalence and lower price of generic medicines, uncoupled from the patents held by major firms, were always hotly contested, and Jeremy’s book shows how debates about branding–or lack thereof–were at the heart of the rationalization of medical practice.
Generic opens with evocative stories about the legal and scientific crises and personal tragedies wrought by tense relations between medical science and industry. We then learn about early debates over international standardization of chemical names and the emergence of firms that marketed generics as a specific kind of product that were a part of the very same consumer-driven value system their proponents wanted to replace. These anonymous drugs prompted research that could establish sufficient similarity between them, while at the same time provoking disputes of authority between physicians and pharmacists that produced a new regulatory regime and standards which were embodied and shaped by emerging large, bureaucratic health care providers. In the end, the story of generics as champions of access and affordability in an age of elusive therapeutics and ‘me-too’ drugs designed to cash in on innovation is complicated by the global changes in production and trade they have wrought. Are ‘global’ drugs perceived as ‘universal’? Jeremy’s book will promote discussion and thought about the medical mundanities we so often take for granted. Generic takes the philosophically-inflected themes of the history of science into a realm of pressing urgency, and reveals fascinating parallels that actually make it more enjoyable for a broad audience.
This interview is the first half of a pair of new books on the pharmaceutical industry; be on the lookout for my next interview with Joseph M. Gabriel about his new book: Medical Monopoly: Intellectual Property Rights and the Origins of the Modern Pharmaceutical Industry (University of Chicago Press, 2014).
Learn more about your ad choices. Visit megaphone.fm/adchoices
Support our show by becoming a premium member! https://newbooksnetwork.supportingcast.fm/drugs-addiction-and-recovery
