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tv   Book Discussion on Generic  CSPAN  April 4, 2015 5:15pm-5:51pm EDT

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relevant -- is as public opinion has softened on marijuana, maybe 60% of people in favor of legalization, the scientific evidence is overwhelming against it. i was drug czar director of national drug control policy '89-'90. we didn't have this research but now it's overwhelming harm that marijuana does, and i have to believe, want to believe the american people are not informed of these facts and so the point of the book was to get these facts out so they can make a second judgment on this an informed decision. get to the end of my story. i think in colorado, which has been kind of ground zero here, they will reconsider at the end of the day to try to put this genie back in the aboutle and recrime a's because they're starting to see recalls. >> you can watch this program
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and others online at booktv.org. >> the book is called "engine nicker." the author is dr. jeremy greene professor of medicine here at johns hopkins university. dr. greene, what's the definition of a generic medicine? >> guest: generic medicine is supposed to the the -- in medicine, we think of them as identicals. they are the same molecule. they're supposed to perform in exactly the same way except they're not exactly the same elm want them to be cheaper. we look at a generic drug as a way of gaining more access at affordable price to medicines which, when they were previously available only by brand number under a monopoly they're much more expensive. a generic drug is a concept. a very contested object. it's a very recent object over the last 50 years. it's become a key point in attempts to try and help american health care be more affordable at the same quality.
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remarkably successful set of policies. 2014, more than 84% of all drugs filled -- prescriptions filled were filled generically trillions of dollars have been estimated to be saved because of substitution of cheaper generic drugs for brand name drugs. but generic drug has been a problem over many years in that we want these drugs to be the same. the fda has elaborated 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 proves that allow generic drugs to circulate in the american healthcare system as exchangeable for brand name drugs, these proofs guarantee similarity not identicallity. if you look at a general generic drug they're different in color, different price, different manufacturer. the politic's science and
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similarity that undergrid the whole generic works to suggest the differences are trivial and the similarities are signaturent but 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 a fascinating in many ways lured and detailed story. >> host: when it come to the generic drug the effect of that drug is the same as the name brands? >> guest: yes, should i say at the outset this book is not an expo say of the generic industry. i can't go a day without prescribing generic drugs itch take generic drugs myself. my children take generic antibiotics when they have strep throat and happens to often, and yet when we begin to look at the concept of a generic drug we realize that our able to call
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these things the same are bears owned a fundamental biomedicine that therapeutics can be reduced to a molecular level. and can cure the disease we hope it cures but we realize the drug is never just a molecule. that molecule is suspended in binders and fillers and it's been wrapped in capsules and put in tablets or suspend elixir and things that are important that may have significant results in people's bodies. i'll give you an example. one of the first big blockbuster drugs to go off patent in the 19 60s was a intoed spectrum antibiotic, park davison's betts seller at the time and it's patent was about to expire. newspapers began to property what's going to happen to park davis when this drug and the
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patent expires and generic competition begins? a set of generic drugs came on the market. all of them had the same amount of in each capsule, and yet some of them had the same amount of clear row in the capsule when it came out of the end of the human volunteer so which is to say molecularly they were the same but the capsule made it through the digestive tract. so the drug was not actually the same. and in addition to these previous chemical tested equivalents thought to be sufficient, there's something else at stake, and the amount of shell lack -- shellac put on the capsule was different and affected how it was absorbed by the human body. what fascinated me the way we know two drugs are the same can
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never be reduced to a molecule alone and part of the history of how generic drugs emerges and the. so consumer in con -- concern in consumer politics there are many ways of defining the same and not the same and this -- what is at stake actually changes over time and requires historic include emergent set of sciences to yard. >> host: how did generics develop? and when? >> guest: 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 to various points of the centuries. what i became interested in is the rise of the modern generic drug industry in the united states particularly after a wave of development of innovative patent protected drugs. that happens the middle of the 20th century. look at thes on the 19th 19th century to first decade's
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of the 20th century, those companies that become the research based pharmaceutical industry were at that point known as ethical drug manufacturers, companies like upjohn pfizer park davis. eli lily, and they all made effective through same drugs they've didn't hold patents. they guaranteed to make their drugs ethically and advertise them responsibly which meant in contrast to pat tent met citizen hucksters they would tell you what was in the bottle the label became very important. and it wasn't until later on in the 20th century that the american system of pharmaceutical r & d develops in awould that the research laboratory is very important and the patents become 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 happened after this burst of innovative
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pharmaceuticals in the putt 20th center began to go off patent. the wonder drugs of the 40s and 50s are beginning to expire and opening up to generic competition. >> host: the patent laws, how do 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 patent laws regard to other substances the united states. they have the 17-year protection that can be extended to 20 years, and during that time part of the bargain made with a patent is that the innovate for discloses they're findings so it's not kept secret, but they are granted a monopoly as a reward for their innovation and for making that innovation public. the patents generate a very sent kind of monopoly and what happens in the wake of those
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patent expirations is that pharmaceutical companies that developed the drugs and given them brand names began to try to extend those patent monopolies into trademark monopoly. so beginning in the 1960s and then amply flies in the 1970s a set of highly visible battle over whether generic drugs are as goods a brand name drugs and the economic self-some on the brand name industry is evident. clearly the able to extend that monopoly is very important to the well-being of the company. at the same time, just because there's difference in interest doesn't mean that the claims of brand name companies that generic drugs aren't exactly the same are necessarily just a form of marketing smoke screen. there's a clash that occurs as the drugs which are expensive go offpatent and brand name manufacturers insist that consumers and physicians should still use the brand name version and can't trust the generic version. the public standards are not good enough to trust they're the
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same. whereas consumer advocates regulators insurers want to insist these drugs are exchangeable and that consumers and physicians should use generic drugs and save the healthcare system a lot of money. very public clashes in the '70s '6s so and volunteer and 80 ares and a series of congressional hearings. as a historian, fascinating to realize that the generic drug isn't something that has been the same over time. it has always either been the famous the brand name drug or different but represents a a space between the two very ideologically opposed interests in which new science, similarity and difference, actually form along the way. >> host: what this role of congress? >> guest: congress played a very substantial role. if you look at the role of senator -- a tennessee pop pop
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listed a co indicating consumer politicness the 60s. he believed he was a chairman of the subcommittee on antitrust and monopoly and he thought that the pharmaceutical industry and the consumer were the ideal test case for the -- elim nating the broader problems in american society, partly because the thought the pharmaceutical consumer were the most captive form of consumer, 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 have to actually look at it and have to buy it. therefore, wanted to advance a broader politic, antimonopolyism, by exploding the problem of pharmaceutical monopolies. 'he thought he could rescue the consumer from that's status by enforcing these generic names and he actually wanted to pass legislation that would
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completely eliminate brand names from the pharmaceutical marketplace and make all pharmaceuticals only available by generic name. actually i brought in a prop today. this is a prop from 1960 and this is -- part of the way die my research is through material culture, often culled ebay. i'd like you to take a quick look at the label and read what the is on and it think about what is present in that explain what is not. just thinking about what the political power of drug names might be. >> this came from compliance klines pharmacy. >> i believe it's in illinois. >> it says one tablet before each meal, doctor wall and at bedtime. this all i'm seeing on here. >> should i be seeing something else? >> that's striking for what i.s. not on there what is not on
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there. >> the name of the medicine. >> so, there's a doctor there's a patient pharmacist, use as directed but they're no name of a medicine, and that's shocking when i found that most of my colleagues in the history of medicine had never described the names of drugs weren't available on pharmaceutical bottles. so i looked at the problem and realized it's not until 1970 that pharmacist are required to put the name of the drug on the bottle. so an ill illustration 0 -- the captive consumer, many consumers went to the pharmacy wouldn't know what they were getting wouldn't know the substance they were getting let alone being able to shop around for it in 1968 the american medical association publishes an mayoral in the journal of the american muscle association saying, you know, it might be about time for us to encourage and allow pharmacists to put the names on the label because it was actually considered up ethical and illegal for pharmacists to tell patients the name of their drugs without the express written permission of their physician, and the -- the ama
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said we should change that. they had a number of physicians write back saying, if you tell patients what's in the bottle you'll destroy the basis of the doctor-patient relationship. why would you think? essentially there's a couple of arguments they make and one is --...
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and ethnical set of precepts of how much you practice. but, of course, we are dramatically different. the framework and medical information it is ours. physicians and pharmacists have no right to exclude are information from us, that is radical change. many lists and modernists they work the 21st century i sometimes hold i sometimes hold this example as an example as hell even within such a recent amount of time, such as decades a dramatic shift in approach is to the body, health and relationships. it also shows the power, kefauver frankly by
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changing the name of drugs generic names and making his name is visible to consumers, you can transform the nature of the pharmaceutical are the archetype. >> host: well kind well, kind of belief that eli lilly, esther seneca's they have put all of this money into research coming to finding a cure, problem ask, they should have the right to market and to sell that product. >> certainly. that is an argument that has no shortage of people advancing it. if if you look at the way generic drug policy has been driven this is the basis of the monopoly. we create things to manipulatives. and generic drugs the
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faster. and one way of looking at it one of the things that compelled me a lot of writing this book is realizing that we have come to accept as natural a two-part lifecycle approach to how does work. an innovative company like eli lilly, pfizer, they invest a lot of money in r&d so very much part of the lifecycle available high price. innovation at the cost of access. and then at the end of the patent live we have generic competition to assume that if more is more and more competitors commend the price will come down which emphasizes access. access over innovation. at tuesday's lifecycle is
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probably the result of a broad handshake. wax hatch act which helps to both extend patents for innovative drug makers and at the same time create a greater pathway for generic competition. one of the problems of that to step pathway is that it is not natural at all. it is something that we have created through a a set of regulatory structures and incentives that are very much a product of human enterprise. and it also neglects and make certain assumptions about how market works. increasingly apparent, what happens when those drugs that are often had been have been for quite some time i no i no longer so exciting to generic manufacturers to make the free market at this that competitors will come in the collected the drag as having three stages. new newly old newly old
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new, newly old part of the 2nd pipeline. generic competitors can meet and then although which is part of how a generic company will develop its own strategy to diversify. the reason i bring this up is not simply an abstract exercise but we have been noticing over the past five years increasingly so a number of essential older generic medications experiencing shortages bottlenecks in production. corresponding. icy cycling exceptionally useful.
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what i was going to my medical residency this was something, infectious disease, talked about is something that doctors should uses said of heavily useful. the price of goods is going out over threefold. understanding how that can happen off patent over decades requires understanding. the marketplace,. the marketplace, looking forward to the knew drugs they can make higher price margins. this can mean knew monopolies this is what led
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me into the book itself, the functions about how it works. think of it as public health. here it is a wonderful and and beneficial to have beneficial industry in contrast to big pharma. and and yet the generic pharmaceutical industry is like any other. it will pursue its own interest. sometimes it creates many problems after one what percentage of drugs on the american market are generic? >> different ways of calculating that figure. the most important is how many scripts are filled at the pharmacy. if you like it 1960, less
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than 10% of prescriptions are filled generically in american pharmacies. by 2014 it is more than 84 percent. this is a seismic shift in the nature of pharmacists in the marketplace. the paradoxical shift. kefauver in congress is advocating this competitive small manufacture monopolistic generic marketplace. he thinks of it as this small, almost mom-and-pop competitive wellspring of american business, but if you look at the generic industry in 2014, it is dominated by a few very, very large players, rentals, and these are not local companies. they are not little pharma opposed to big pharma, they are just as big and multinational in the construction as any other brand-name pharmaceutical company's. part of part of it in the history of generic is the transformation happening. and still treat generic as if they are still somehow
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small farmer compared to big pharma command we need to recognize they are effectively globalized. the generic giants are increasingly a reality. after one are of people going into the doctors because of advertising on tv and saying i want that drug? >> guest: yes yes most definitely. i'm glad you bring this up. the question is directed a consumer advertising in this important. it's part of why i as a physician and historian find myself drawn to this project. i entered medical school in 1797 command that year, as you might remember, was the year that the fda changed its regulations regarding broadcast advertising direct to consumer advertising for consumer drugs. but the kings have not been worked out. you might remember's
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heavily marketed at the time and was really brand-new at the time, the ads were segmented into some that had a giant clear sky. and others which described this new and innovative medication for allergies. by the end of the year, however, as i made way to have made my way through medical school those kinks have been worked out. prescription drug advertising for drennan to have brand-name drugs was seen in stadiums and becoming increasingly common and so at this.i'm thinking several decades later we are now somewhat immured to the presence of direct to consumer advertising. advertising. at the time of the shocking to see just how dominant the brand-name ways was and how powerful forces of pharmaceutical market were.
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i came i came in the medical school thinking, here is this brand-name part of the marketplace. here is what i am learning in medical school which is the generic name, the generic name is a scientific thing, something which is somehow related us to the use value rather than the exchange value of the drug. the autonomy of thinking as a single to marketplace was i think was, i think, shared by many of my professors for medical school. some one of the things that i began to i began to encounter as i was doing research on that you my easily the fda. a family and archives.
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in that i don't smoke all the --'s chief of -- what i found powerful is not expected to five. it's what i found was a complex institute in the making clearly understood my contemporaries as it becomes increasingly important of february american healthcare and deserves more scrutiny and understanding. >> host: how to insurance companies and healthcare laws treat generics? >> guest: this is an
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important question. i we will question. i we will back up for a moment answering. it's generics are in some ways the most modified aspect of healthcare. the medicine is supposed to be interchangeable with other medicines marketed on the basis of being the same. i became i became interested in how generic represents ultimate qualification. how is that commodity produced. what when does it come into being, however they made have they circulate, or the sciences that allow regulators to cultivate drugs and what are the incentive structures and encourage physicians and patients to use generic drugs and then finally how are they consumed? what forms of resistance have emerged among consumers and physicians's. so the question asked about insurers in particular is
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important and a key part of this book one of the reasons they are so widely used today is because the broad bureaucratic system that helps to decide which medicines are insurers will pay for, the prices will be will be should oppose the pharmacy effectively steers are behavior as consumers. this is a concept built over time. this paternalistic model of medicine. and it took a lot of work for that edifice which is restrained prescribing pharmaceuticals to take shape. there is legal structures. they have passed anti- substitution laws.
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it's the 70s and 80s they are placed with substitution laws would mandate from system to system to have substitute. there is a legal system that begins to set up this practice of substitution and then it is complemented by a private sector and insurance structure which begins to realize cost and savings these forms of cost savings that have been incredibly important to helping keep our health system viable to the extent that it is viable. how untenable's generic
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drugs appear as an incredibly rare success story in this set of otherwise failed tests to rein in healthcare costs equivalent quality care bill was structures they begin to become more and more evident in how medicine is practiced in and how consumers feel there ability or inability to pursue their strategy at the pharmacy. one way one way in which we see it increasingly is moving beyond the structure of generic substitution us. i we will pave for you to have this molecule up in your body, it only is it that the generic price. our reimburse the the generic but not the brand-name. the structure of what is now called therapeutic substitution in which an insurer we will say, well sure you should be on staten, but there are eight on the market's and we are not going to reimburse you
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for take this most expensive one that is a -- is not generic differ generically available's. the same kind of drug. so this practice of therapeutic substitution similar set of policies that takes generic substitution as a model but extended into a realm in which one drug can be substituted for another class. so it's not a problem suggests that they will reimburse you. to the medical literature suggests some assertiveness training is to this more complicated. cancer care for example the contests for what it means to call two different drugs equivalent or exchangeable. these concepts are more accessible in america today.
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>> host: have you as a personal physician had fights? generic substitution is which is therapeutic substitution. one of the ways in which ensures have built the structure that helps is to never directly tell a physician that they cannot prescribe a drug. increasing the amount of work that a physician a physician must do. there's something called the parable. there is one pathway all the bureaucratic raffles that one finds in the structure. but in order to have a patient of mine in excess or get this straight reimbursed
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and he develops of the forms were spent time in a telephone a convince someone on the other end of the line the patient's needs more this exceptional case no absolute barrier so the natural path of least resistance is to prescribe the preferred drug companies are levers: has been called enlightened paternalism for the structure of incentives make it such that doing with the insurers would like to maximize, rational course of achieving cost savings for the perceived to be equivalent drug is the outcome terms of opposition between reason and rationality. it's doctor strangelove for example again, paid by you
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have played by peter sellers, eloquently rational madman who is pursuing a set a set of actions that lead to world distraction and arrives there by incredibly rational threats -- rational steps. this idea that one can create a rational system and as an advocate with something that has embedded as being equivalent is not equivalent from one's own bodily experience. one needs to advocate for oneself that this reasonable instance may not follow after one john hopkins professor of medicine, doctor jeremy green, author of this book's generic the
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unwinding of modern medicine. thank you. thank you for your time. >> thank you so much. it's. >> book tv is on twitter. follow twitter. follow us to get publishing news, scheduling updates author updates its. twitter .com/book tv. >> isis is calling on its followers come join the caliphate but it is a a good thing if you stay put. in chicago new york, london, berlin's isis -- isis calls than city rules and they are calling them to rise up. you can be a one-man jihad in your own backyard.

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