when the thugs and scofflaws show up in your neighborhood as they sometimes do, you will be grateful to know that cop is to walking his old beat reassuring presence in the still dangerous world. make that case that why america should be the world's policeman. i don't think necessary popular image. >> guest: what about new zealand? newseum is a lovely country. we are not a country that will be irrelevant to the rest of the 20%. we are still going to be the premier, the preferred target for terrorist. but we are still going to be the country china is going to want to replace. we are still going to be involved in the struggles and the future of little countries from estonia to taiwan to israel, poland and so on. we are going to be the world's number one country for the rest of this century because this is a country with amazing capability of renewal and regeneration. and so we're not going to be able to essentially say, well

we just want to be a pleasant little country on the fringe of the world, leave us alone. the world will not leave us alone whether we like it or not. we have to decide how we want to behave in that world. for almost seven decades we have shouldered the role of being the world's policemen but we have also benefited the most big the world's policeman. we benefited from this remarkably free, prosperous, technologically advanced integrated network world and we want the world to carry on. no one was watching this show would say well this is the ideal world. i don't ever watching the show says what i really want to do with my life is be a cop. but nobody watching his wants to live in the neighborhood without a cop. we don't want to live in a world without a cop either. i would rather have america be that cop that vladimir putin or ban ki-moon or the ayatollah khamenei.

that's the real choice that we face. we have to face with some sort of sobriety and series is about what our options are and understand that what we are doing is not all tourism. it's above all self-interest, self-interest properly understood which is the great basis of all smart american policies. >> host: thank you for writing the book and talking about it. >> guest: thanks, bob. ..

the book is called "generic," is author is dr. jeremy green who is a professor of medicine here at johns hopkins, university. dr. greene what's the definition of a generic medicine? >> guest: oh a generic medicine is supposed to be the same as a brand name medicine. we think of them as identical they are the same molecule, they're supposed to perform in exactly the same way except that they're not exactly the same. we want them to be cheaper. we look at a generic drug as a way of gaining more access and affordable price to medicines which, when they're previously available only by a brand name under a monopoly are much more expensive. so a generic drug in some ways is a concept it's a very contested object, and it's a very recent object over the last

50 years. it's become a key point in attempts to help american health care be more affordable at the same quality. in some ways it's been remarkably successful as a set of policies. in 2014 more than 84% of all drugs, prescriptions filled at the pharmacy were filled generically. trillions of dollars have been estimated to be saved because of substitution of cheaper generic drugs for brand name drugs. but the generic drug has been a problem over many years in that we want these drugs to be the same. the fda has elaborated very detailed structures to help them be exchangeable, and yet they're never exactly the same. they're not identical. if you look at the network of proofs that allow generic drugs to circulate through the american health care system as exchangeable for brand name drugs, these proofs guarantee similarity, not identicalty. for example, if you look at a generic drug, it could be a different color often, it'll be

different in price, it'll come from a different manufacturer. but the politics and science of similarity that undergird the whole generic infrastructure work to suggest that those differences are trivial y'all and the similarities -- trivial and the similarities significant. and when you look at the structure historically, it wasn't built overnight, and understanding how it was that we have learned what differences are important and what differences are trivial in calling two things the same in modern medicine is actually a fascinating, in many ways, lurid and detailed story. >> host: well, when it comes to a generic drug are the so-called chemical compounds of that drug the effect of that drug the same as the name brand? >> guest: yes. and i should say at the outset this book is not an expose of the generic drug industry. i can't go a day in practice was prescribing a generic drug. as a patient i take generic drugs myself my children take generic antibiotics when they

have strep throat which happens, as you know far too often. and yet when we begin to look at the concept of a generic drug, we realize that our ability to call these things the same are based on a fundamental concept in biomedicine that we believe that therapeutics can be reduced to really a molecular level. what really counts in a medicine is a molecule, that it works in a mechanistic way to cure the disease that we're hoping it to cure. and yet as we look in more detail at what a generic drug is, the drug is never just a molecule. that molecule is suspended in binders and fillers and it's been wrapped in capsules or put in tablets or suspended in elixir, and there are all kinds of differences in the things that we don't think are important that may eventually actually have significant results in poem's bodies. in people's bodies. i'll give you an example. one of the first big blockbuster drugs to actually go off patent in the 1960s was a broad spectrum antibiotic.

it was park davis' bestseller at the time. as its pat tent was about to expire newspapers began to report what's going to happen when this drug patent expires andgeneric competition begins? all of them had the same amount of the ingredient in each capsule, and yet some of them had the same amount in a capsule when it actually came out the other end of the human volunteer. which is to say molecularly these two drugs were the same but if the capsule made it all the way through the digestic track without any of that drug being absorbed, well, then the drug was not actually the same. so there was something else at stake. and it turned out the amount of shellac that was put on the capsule differed the starches and binders differed and that affected whether it actually worked in the human body.

so what became fascinating to me in the course of researching this story is that the way that we know two drugs are the same can never just be reduced to a molecule alone. and part of the history of how generic drugs emerge as a market and emerge as a subject of regular laughs at the fda -- regulation at the fda is that there are many ways of defining the same and not the same. and this -- what is at stake um actually changes over time and requires a historically-emergent set of sciences to understand. >> host: dr. greene, how did generics develop? and when? >> guest: well, there are many -- so in this story is really a late 20th century story as i tell it. one can find different imitations or copies of innovative drugs going back at various points over the centuries, but what i became interested in is the rise of the modern generic drug industry in the united states in particular are really comes after a wave of development of innovative

patent-protected drugs that happens in the middle of the 20th sently. and you -- isn'tly. and you look at the end of the 19th century to the first decades of the 31st century -- 21st century, those companies were known as ethical manufacturers, upjohn pfizer, park davis, eli lilly. and they are made effectively -- they all made effectively the same drug cans. they didn't hold patents on their drugs. they guaranteed to make their drugs ethically and advertise them responsibly which meant they would tell you what was in the bottles. the label became very important. and it wasn't really until a little bit later on in the 20th sent -- century that r&d develops in a way in which the research laboratory becomes very important and the patent becomes important as a way for an innovative company to protect its molecule. so one molecule is only available from one pharmaceutical house under one

brand name. so the emergence of the generic drug industry really happens after this burst of innovative pharmaceuticals in the mid 20th century begin to go off pat tent. so you start seeing these concerns developing in the 1960s, 1970s at first as the wonder drugs of the '40s and '50s are beginning to expire and opening up to generic competition. >> the patent laws, how did they -- well, what are the patent laws with regard to drugs? >> guest: sure. well the patent laws with regard to drugs aren't that much different as those in regard to other substances. they have a 17-year protection that can be extended to 20 years, and during that time part of the bargain that is made with a patent is that the innovator discloses their finding, so it's not kept secret. but they are granted a monopoly as a reward fir their in-- for their innovation and for making

that innovation public. patents generate a very certain type of monopoly. and what happens in the wake of those patent acts is that pharmaceutical companies that have developed these drugs and given them brand names began to try to extend those monopolies into trademark monopolies. so it begins in the 1960s and amplifies in the 1970s a set of very highly visible battles over whether generic drugs are add -- as good as brand name drugs. clearly, the ability to extend that monopoly is very important to the well being of a company. at the same time, just because there's difference in interest doesn't mean that the claims of brand name companies thattier network drugs aren't exactly the same are necessarily just a form of marketing smoke screen. so there's a clash that occurs as these drugs -- which are very expensive -- begin to go off patent where brand name manufacturers insist that

consumers and physicians should still use the brand name version and can't trust the generic version, that public standards are simply not good enough to trust that they're the same whereas consumer advocates regulators insure ors want to insist that these drugs are exchangeable and that consumers and physicians should save the health care system a lot of money. and there's very very public clashes in the '60s and '70s and '80s that take place. you can narrate them over a series of congressional hearings as well. as a historian it became fascinating to realize that the generic drug isn't something that has been the same over time but represents really a dialectic, a space a historically-emergent space between these two very i'd ideologically opposed interests in which new sciences actually form along the way. >> host: how -- what was the role of congress? >> guest: well, congress played a very substantial role in, on the one hand you said if you look at if you look at the role

of senator -- [inaudible] for example a populist really interested in advocating consumer politics in the late '50s and early '60s keefe hover believed -- he was the chairman of the subcommittee on antitrust and monopoly, and he thought the pharmaceutical industry and the pharmaceutical consumer was the ideal test case for illuminating the broader problems of monopoly in american society. and partly because he thought that the pharmaceutical consumer was the most captive form of consumer. effectively, had no choice over the decisions they were making. the doctor would write a prescription, the patient would take it to the pharmacy, and they would simply just have to actually look at it. and you have to buy it. he therefore, wanted to advance a broader politics of aunt-no knop limb -- anti-no knop limb. he thought that he could rescue the consumer from this captive

status by enforcing the use of generic names and he actually wanted to pass legislation that would completely eliminate brand names from the pharmaceutical marketplace and make all pharmaceuticals only available by generic names. actually, i've brought in a prop today which i know you have, and this is a prop from 1960. and this is -- part of way i do my research is through culture this particular prop came from ebay. and i would like to ask you to take a quick look at the label and read what's on it and think about what is present in that label and what's not present in that label just thinking about what the political power of drug names might be. >> host: this came from klein's pharmacy, wherever that is. >> guest: i believe it's in illinois. >> host: and it says one tablet t before each meal, dr. haniwald and at bedtime. this is all i'm seeing on here.

should i be seeing something else? >> guest: that's really striking for what's not on there. what was not on that label you just read? >> host: the name of the medicine. >> guest: there's a doctor there's a patient there's a pharmacist, there's use as directed, but there's no name of a medicine. and this really shocked me when i found this. most of my colleagues in the history of medicine, no one had really tribed that the names of drugs -- described that the names of drugs weren't available at this particular time. @not really until 1970 that pharmacists are required to put the name on the drug on the bottle. so as an illustration of what the senator's talking about he's talking about the captive consider. many consumers going to the pharmacy wouldn't even know what they were getting, the substance they were getting, let alone have the ability to shop around for it. interestingly enough, in 1968 the american medical association publishes an article saying, you know it might be about time for us to encourage and allow pharmacists to put the names on the labels. because it was actually

considered unethical and illegal for pharmacists to tell patients the name of their drugs without the express written permission of their physician. the ama said we should change that, and they had a number of physicians write back angrily saying if you do that, you'll destroy the basis of the doctor/patient relationship as we know it. why would you think? so essentially, there's a couple arguments that they make. one is that if you, if you tell patients what's in the bottle, then we can't use placebos anymore. so doctors were still actively pubing placebos to patients -- >> host: so this bottle may have been initially been filled with a la placebo, i have no way of knowing. it illustrates something very powerful in this moment that what we call a paternalistic model of medical care where the physician would know certain things they would withhold from the patient. it was common practice not to

tell a patient when they had a terminal diagnose diagnosis. simply, it was believed not to tell the patient what they were taking was not just a conspiratorial scheme by physicians and pharmacists but actually written into a fundamentally different ethical set of precepts of how one should practice medicine at that point in time. of course, we were calling it an egalitarian framework. the medical information is ours we deserve it, the physician or pharmacist has no right but that's a radical change that's happened in the last 50 years. so my colleagues in history who are early modernists who sometimes say i'm basically a journalist because i work in the 20th century i sometimes hold this example up as ap example of how recently within five decades one can witness such radical shift in cultural approaches to the body, health and disease and the relationship between doctors and patients.

it also shows the power of a name, the idea that a generic -- what you see in this bottle some of the animus behind why keith offer thought simply by changing brand names to generic names and then making those names visible to consumers, he could transform nature of the pharmaceutical marketplace in a way that would empower everyday americans. >> host: well, jeremy greene, there's a counterargument that the eli lilies and the astrazenecas have put all this money into research and finding a cure to problem x, they should have the right to market and to sell that product. >> guest: oh, yes, certainly. and i think that's an argument that has no shortage of representatives advancing it in american health politics. also you look at the way that generic drug policy has been one, um, this is the basis of the patent monopoly. so we have, we grant patents to innovators during that time period, the medicines can be

sold at pretty much any price and generic drugs are understood to come after the period that patent monopoly ends. one way of looking at it and one of the things that impelled me along writing this book is realizing that we have come to accept as natural a two-part life cycle approach to how drugs work, that an innovative company, an eli lily, a pfizer of the world will invest a lot of money into r&d, will need to recoup those costs once its drug becomes available on the american market. the first patent-protected part of the life cycle, the drug is available at a very, very high price. so it rewards innovation at the cost of access. and then at thened of the patent -- the end of the patent monopoly, we assume that more and more competitors will come in the price will come down and then we'll reach an affordable level, and that emphasizes access rewarding access over innovation. and in effect, this two-stage

life cycle, right, is partly the result of the broad handshake agreement made in 1984 with the wax-hatchman act which helped to extend patents and at the same time create a pathway for generic competition once patents expire. one of the problems of that two-step pathway is it's not natural at all right? it's something we have created through a set of regulatory structures and incentives that are very much a product of human enterprise right? and it also neglects -- it makes certain assumptions about how markets work which neglects a bit of a third stage which is becoming increasingly apparent which is what happens when those drugs that are off patent and have been off patent for a while are no longer so exciting to generic manufacturers to make. so, for example we assume that the free market will just insist that people, that different competitors will come in and

make generic versions of a drug once it's off patent but you could look at a drug as having three stages. when it's newly new, when it's newly old at which point it's part of a e generic pipeline and different generic competitors compete with one another to be the first in the door to make it, and when it's nearly old old and is not part of how a generic company will develop its own strategy for how to diversify its line in the future. the reason i bring this up is not just as an abstract exercise, but because we've been noticing the past five years, increasingly so in the past two years, a number of essential older generic medications are experiencing shortages where there's bottlenecks in production in only one and sometimes no companies are producing it and corresponding price hikes where an old medicine where a basic antibiotic approved in 1967 -- still exceptionally useful in general internal medicine

practice -- when i was going through my medical residency this was something the infectious disease intending talks about as something doctors should use. here's a drug that's pennies a pill and just as useful as many of the newer drugs. a bottle a 500-count last october cost $20, a 500-count this last, this october cost nearly $1800. and understanding how a price hike can happen in a medicine that has been off patent for several decades requires an understanding of that third stage, that the generic marketplace is actually a competitive marketplace which is geared towards innovation itself. looking forward towards the new drugs about to become generic where they can actually make higher price margins. and this leading edge of old old drugs can actually be neglected and result in new

oligopolies and monopolies. so this is part of what led me into the book itself is realizing we have these assumptions about how the generic marketplace works which almost think of the generic industry as if it's an outgrowth of the public health service. here's this wonderful beneficial industry that helps make drugs accessible in contrast to big pharma which, you know charges high prices and is rewarded for innovation. and yet the industry is an industry like any other. it's neither moral, nor immoral moral, it's simply amoral and it will pursue its own interests within the policy environment it's shaped for, and sometimes that policy environment has to create really devastating problems that we need to attend to. >> what percentage of drugs on the american market are generics? >> well, so there's different ways of counting that figure. the one that i think is most important is how many scripps are fills -- filled at the pharmacy. in 1960 less than 10% of prescriptions were filled

generically in american pharmacies. by 2014 it is more than 84% of prescriptions. so this is a seismic shift in the nature of the pharmaceutical marketplace. along with that shift, though lies a set of other paradoxical shifts that come along. when the senate and congress is advocating this competitive small manufacturer nonmonopolistic, generic marketplace, he thinks of generic firms as these small, almost mom and pop competitive wellspring of american business. but if you look at the generic industry in 2014 it's dominated by a few very very large players, and these are not local companies. they're not little pharma to be opposed to big pharma, they're just as big and multi-national in their construction as any other brand name pharmaceutical company. so part of understanding the history of generics is the transformation that's happened in that sector.

implicitly, we often still treat generics as if they are somehow a small pharma compared to a big pharma, and we news to recognize that they are effectively globalized, that the generic giants are increasingly a reality of the pharmaceutical marketplace as we know it today. >> host: are people going into their doctors because of advertising on tv and saying i want that drug, not, you know with a specific name? >> guest: so yes, most definitely. >> host: has that been helpful to pharmaceutical companies? >> guest: certainly. [laughter] yes, it's certainly been helpful to pharmaceutical companies. i'm glad you bring this up, because the question of direct to consumer advertising is very important to the structure of this conversation. it's part of why i as a physician and a historian found myself drawn to this project. when i entered medical school actually my first year in medical school was 1997, and that year as you might remember was the year that the fda changed its regulations regarding broadcast advertising, direct to consumer advertising for prescription drugs.

but the can kinks hadn't fully been worked out at that point, and you might remember some of the advertisements, for example for claire tin which was being heavily marketed at the time, and it was really brand new at time but the ads were segmented into some ads that had a giant, clear sky and the word cl ark ritin and no description of what it did. and there's a new innovative medication for allergies, see your doctor ab it. -- about it. by the end of the year, those kinks had been worked out and prescription drug advertising for brand name drugs was seen in stadiums erectile dysfunction drugs were becoming increasingly common as interludes in baseball games. and so at this point i think several decades later we are now somewhat inyou ared to the presence of inyoured to direct to consumer advertising but at the time it was shocking and new

to see just how dominant the brand name was and how powerful the forces of pharmaceutical marketing were. i came into medical school thinking here's this brand name which is part of the marketplace, and here's what i'm learning in medical school which is the yes network name, and the generic name is a scientific thing. it is something which is somehow related to the use value rather than the exchange value of a drug. and that dichotomy of thinking of the brand name drug is somehow a thing of the marketplace, the generic drug is a thing of science was i think shared by many of my class mates, many of our professors in medical school as well. one of the things that i began to encounter as i was doing research for my first book was that it didn't always line up this way that the generic name was not something made of pure science, and it wasn't something that was univ.al either. universal either. and generic drug companies had their own market interests and were often mall feasant players

vis-a-vis the fda. and as i found my way into archives and i was lucky enough through a freedom of information request to the fda to gain access to all of their letters to and from a set of companies that became the early american yes e network drug industry began to realize this statement that i said earlier, which was that the generic drug industry was not a creature of pure saint or merely a hand maiden of public health but motivated in its own way. it was, in many ways my own conception of the power of the brand that drove me to study the generic. what i found however, was not what i expect expected to find. i did not -- what i found instead was a complex industry in the making one that was poorly understood unlike contemporaries that as it becomes increasingly important to the fabric of american health care really deserves more scrutiny and more understanding. >> host: dr. greene, how do insurance companies and health care laws treat generics?

>> guest: so this is a very important question and i'll back up for a moment in answering it. the way i approach the book is through a three-part structure. generics are in some ways the most commodified aspect of the health care system, right? the medicine is merely interchangeable with other medicines, marketed on the basis of its sameness. so i became interested in how generic drugs represent the ultimate commodification of ed many sin, if you do -- medicine if you will. how are generic drugs made, what is a generic name, how do they circulate, what are the sciences that allow regulators to call generic drugs the same as their brand name counterparts, and what are the laws and incentive structures that encourage physicians and patients to use generic drugs instead of the brand name parts? and finally, how are they consumed? what forms of resistance have emerged both among consumers and amongst physicians?

in many ways immediate consumers of drugs themselves. the question you with asked about insurers in particular is a very important key middle part of this book. one of the reasons that generic drugs are so widely used today is because the broad bureaucratic system that helps to decide which medicines our insurers will pay for what the prices will be when we see the price at the pharmacy really effectively steers our behavior as consumers to a dramatic extent, and this is an edifice that had to be built over time n. the beginning of my story in the 1950s and '60s and this paternal model of medicine, no one could tell a physician what drugs they could and could not prescribe, and it took a lot of work for that edifice which has slowly really constrained the prescribing abilities of the to everyday physician and really shaped the environment of the pharmaceutical consumer to take shape. ..

i got me to cast out as the villainous or problematic structure. i think that these forms of cost savings have been incredibly important to helping keep our system viable to the extent it is viable. we let how increasingly loaded and untenable the continued growth of health care expenditures are. generic rugs appear of an

incredibly rare success story in the set of otherwise reining in health care costs of equivalent quality care. the structures begin to be more evident in how medicine gets cracked is. consumers wield the ability or inability to pursue therapeutic strategies at the pharmacy. one way in which we see it increasingly is moving beyond the structure of generic substitution where they say i will pay for you to have this molecule put in your body, but only at the generic price. so i will the generic version. you can buy that. therapeutic would say you have high cholesterol and you should be on staten. but there's eight in the

american market right now and i'm not going to reimburse. we are not going to room three years this most expensive that is not generically available. we will reimburse you the price of a different molecule, which is the same kind of chart, which is available more cheaply. this therapeutic substitution. it takes generic substitution and extended to iran but what struck to be substituted for another in its class. and some it's not a problem. for example if you have allergies and they reimburse you for claritin and not their check. some might demand claritin, but most of the literature suggests there's not much of a difference between those two. it gets more complicated like cancer care for example, where the contest of what it aims to call two different drugs

equivalent if one is cheaper than the other gets a lot more heated. these contents are still planning out in america today. >> host: have you as a had fights with insurance companies over generics? >> guest: yeah although the fights have not had to do with generic substitution as much as therapeutic substitution. one of the ways in which insurers have built the structure that helped to instead the use of certain cheaper drugs over other drugs is to number directly tell physicians that they can prescribe a drug. increasing the amount of work a physician must do to get the drug approved for a patient. there's something called prior approval, for example. one pathway down all of the bureaucratic radicals that one finds in the structure. the prior authorization means

that in order to have a patient of mine can access or get this drug reimburse, i need to fill out a set of forms or spend time on a telephone and convince someone on the other end of the line that the patient needs more and this exceptional case of using this medicine instead of another. you can see in this question there's no absolute carrier. a physician can do this but there's increasing work to make it happen. the natural path of least resistance is to describe the preferred drug. these are lovers. this is what is called enlightened paternalism, the structure of incentives make it such that doing what the insurers would like to maximize, the rational course of achieving cost savings for the equivalent drug is the outcome. as a physician however emancipation, we need to