this is one of the relatively recent discoveries that all of that stuff is out there and falling on are they the kind of organic that come from the universe or are they the kind of things that life builds because organics come out way as well. that will be one of the big challenges if they find organics. i can't say too much about this, there'll be some scores fairly soon. the issue over time is to these organic molecules, rows that are sent a living that brought them together.

[inaudible] [inaudible] and to understand the geology so they can determine what happened at a particular place at a particular time. and do it by carbon dating.

they have techniques. they determine age by using the gas line. and the relationship between those can be measured and understood in a way that would give you a sense of how long ago well beyond my understanding but suffice it to say that these folks, based on what they know on earth and what they understand that mars has the same process or a very similar

process they are making judgments that can stand the test of time. i think we better bring it to an end. i'm sorry. [applause] [inaudible conversations] >> the book is called "generic: the unbranding modern medicine." ya there is dr. jeremy greene, professor of medicine at johns hopkins university. dr. graham, what is the

definition of a generic medicine? >> a genetic medicine is supposed to be the same as a brand-name medicine. they are the same molecule. they're supposed to perform in the same way except they are not exactly the same. we want them to be cheaper. we look at it as a way of gaining access to affordable price, which previously was only buy brand-name and were much more expensive. a generic drug in some ways affects the contact over the last 50 years. it has become a key point in attempts for the american health care be more affordable. it has been remarkably successful in set of policies. 2014, with an 84% above the prescription filled pharmacy was still generically. trillions of dollars because the

substitution issued for generic drugs are brand-name drugs. the generic drug has been a problem over many years and that was one of these drugs be the same. i elaborated structures to be exchangeable and yet there are exactly the same. if you like at the networks approve for the these proves demonstrated it will be different than price. it will come for a different manufacturer. the politics of similarity that underwent the whole generic infrastructure work to suggest that those differences are trivial and the ladies are significant. it wasn't built overnight and understanding how it wasn't we

learned it was fascinating in many ways. >> when it comes to a generic drug, the chemical compounds of the job is the effect the same as the name brand. >> it is not an exposé. i can't go a day in practice without describing a generic term. as a patient, myself and my children take generic in a biotic when i have strep throat, which is not too often. and yet, when we began to learn about the concept our ability is based on the fundamental biomedicine that we believe the therapeutics can be reduced to believe molecular level. that really counts in the medicine is that molecule works

in a mechanistic way to cure the disease they are hoping to cure. and yet as we look in more detail we realize it's never molecule. it has been wrapped in tablets or suspended analects are. there's all kinds of differences in the theme that we don't incur important that may eventually have significant result. i'll give you an example. one of the first big blockbuster drugs to go off patent in the 1960s but a broad spectrum the bestseller at the time. the patent was about to expire in began to to report what will happen when the patent expires in generic competition begins. the generic drugs came on the market. all of them had the same amount in each capsule. and yet, some of them had the

same amount i capsule when it actually came out the other hand which is to say molecularly these two drugs were the same, but it made it all the way through the change is to track. it was not actually the same. in addition to these previous chemical past, there was something on senate turned out the amount of shellac that was on the capsule. this is between the starches and binders and not affected whether it actually worked in the human body. what became fascinating to me in the course of researching the story is the way we know two drugs are the same as they can never be reduced to a molecule alone. part of the history of how generic drugs emerge as the market in the subject of regulation and the fta and concerning consumer politics is there are many ways of defining the same and what is at stake

actually changes over time and requires the emergence that aside. how did this story is really of late 20th century story. at various points over the centuries. but i became interested in it really comes after a wave of development of innovative patent protected drugs. it happened in the middle of the 20th century. if you look at the end of the 19th century the first decades of the 20th century, those companies that become the firm's typical industry for at that point known as apical drug manufacturers. something like pfizer, parke-davis, they're effectively

the same drugs. they guaranteed to make they are drugs at the cleanup or type them responsibly. they would tell you what was in a bottle. so it became very important. and it wasn't really until later on in the 20th century that the american system of pharmaceutical develops in a way in which the research laboratory of the concern in the patent becomes important as a way for companies to protect his molecule. someone molecule will be available for one pharmaceutical house underwent brand-name. the emergence of the generic drug industry happens after the pharmaceuticals amid 20th century. we start taking these concerns and opening up the competition.

>> a patent laws. what are the patent laws with regard to drugs? in the protection to 20 years and during that time, part of the bargain is made is the innovator discloses the findings. it's not kept secret, but they are granted a monopoly as a reward for the innovation and the public. they generate the very certain kind of monopoly. in the pharmaceutical companies that have developed these drugs and give them brand names began to try to extend into trademark monopolies. so it begins in the 1960s and

amplifies is a set of very highly visible batters. clearly the ability to extend that monopoly is very important to the well-being of the company. at the same time, because there is difference in interest doesn't mean the claims are brand-name companies in generic drugs aren't exactly the same or necessarily just a form of marketing. so there is a clash that occurs as these drugs which are very expensive begin to go off patent where manufacturers insist consumer should still use the brand-name versions and can't trust the generic urgent. the public standards are simply not good enough, whereas consumer advocate insurers want to insist these drugs are exchangeable and consumers and physicians should use generic drugs. in the 60s and 70 is an 80s.

it was fascinating to realize and historically between these two very ideologically opposed interest in which new sciences actually form along the way. >> whose the role of congress? >> congress played a very substantial role. on the one hand if you look at the role of the senator, for example, he's really interested in advocating consumer politics. late 50s and early 60s. he believed he was the chairman on antitrust and monopoly and he thought that the pharmaceutical industry and consumer was the ideal test case for eliminating

the broader problems in american society. partly because he felt the pharmaceutical consumer was the most captive form of consumer and had no choice. the patient would take it to the pharmacy and have to buy it. he wanted to advance a broader policy by exploding this problem. he thought that he could rescue the can dinner from this active status by enforcing the generic names. he actually wanted to pass the legislation that would completely eliminate brand names and make it available by generics. i brought in a prof today from 1960. this is -- part of the way i do

my research is through material culture. this particular one came from ebay. i would like to ask you to take a quick look at the label and read what is on it and anger about what is present in what is not present just thinking about the political power of drug names would be. >> this came from clients pharmacy. >> i believe clients pharmacy is in no annoyed. -- dave in illinois. >> dr. hannah wald. this is all i'm seeing on here. should i be seeing something else quick >> that is really striking for what is not on the label. so is the dock there and pharmacists. and there's no name of medicine. at this time to look at this

problem and realize it's not really in some 1970 that pharmacists are required to put the name of the drug on the bottle. so what keith alvarez was talking about is the consumer. many wouldn't even know what they were getting. let alone have the ability to shop around for it. interestingly enough in 1968 the american medical association publishes saying you know it might be about time for us to encourage and allow pharmacies to put names on the label. it was considered on a cocoa for pharmacies without their condition. they had a number of positions saying if you do that, if you tell patients within the firm it will destroy the doctor patient relationship. why would she think essentially

if you tell patients within the bottle, but can't have placebos anymore. doctors were still actively prescribing placebos to patients in the time that these bottles were filled aired in may additionally been filled, but there's something powerful in this moment that we call medical care where the physician would know certain things they withhold from the patient. it was, in part this when they had a terminal diagnosis because they believe that might make the patient do worse than give up hope. similarly, we not tell the patient that was just a conspiratorial team with the ethical preset at that moment in time. but of course mr. manically

different. that's a radical change; it's in history in early madness can be journalists in the 20th century. i sometimes hold this as an example of how it even within such a recent period of time we could witness such a radical shift in cultural approaches to the body health and disease in relations between doctors and patients, but also the power of the name. you see in this of the animus behind why they fast simply by changing the names of drugs generic names and then making those things visible to consumers, he could transform the pharmaceutical marketplace in a way that would empower everyday americans.

>> there's a county argument that the eli lilly and some of the astra seneca has put all this money into research and finding a cure to problematics. they should have the right to market and sell the product. >> that's an argument that has so shortage of representatives and when you look at the way it's been written, this was the monopoly. we grant patents to renovators during that time. to be sold in any after that. after the monopoly. one of the things that impelled me in writing this book is realizing that we have come to accept a natural two-part lifecycle on how drugs work. an innovative company like eli lilly, the pfizer of the world

works a but we need to recruit those costs once it's drugs on the available market. survey of the the first patent protected lifecycle and is available at a high price. it rewards innovation at the cost of access. at the end of the patent monopoly, we have a pathway for generic competition to assume more and more competitors will come in the price will come down and reach an affordable level and that emphasizes access. in easizes access. in effect, this lifecycle is partly the result is the broad handshake agreement and hopes to extend patterns for innovative drugmakers and create a clear pathway once it expires. then the problems of the two-step pathway if it is not natural at all.

it is something we have created through a set of regulatory structures that are very much a product to human height. it makes certain assumptions about how markets work which is a bit of a third stage becoming increasingly apparent, which is what happens when those drug better 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 different versions. you can look at a drug is having three stages. when it's new and part of the second pipeline, generic pipeline with different competitors with one another to be the first one in the door to make it. and then it's old old and not a part of how i generic company will develop strategies to how

to diversify in the future. the reason i bring this up is not an abstract exercise, but we have been noticing an increasing in the past two years that a number of essential older generic medications are experiencing shortages, withers bottlenecks in production, only want and sometimes no companies are producing it. corresponding price hikes for an old medicine like try cycling which is the basic antibiotic approved by the fda in 1967 is exceptionally useful in general medicine crack this. when i was going through my medical residency cometh at an infectious disease talked about is something that doctors should use instead of the newer heavily advertised brand of drugs coming here is a drug available at pennies a pill that is still at useful as many drugs. last october it costs $20. a 500 count bottles this last

act over cost nearly $1800. it has been off patent for several days requires the generic marketplace is actually competitive marketplace, which is geared towards innovation itself, looking forward toward the drugs about to become generic where they can actually make higher price margins and the leading edge of old old drugs can be neglected and resulted monopolies. so this is part of what led me into the book itself is realizing the assumptions about how the generic marketplace works. think of the generic industry is that the public house. here's the beneficial industry that hopes industry that helps make drugs accessible.

it's neither moral or immoral. and will pursue its interests and sometimes the policy environment has to create truly devastating problems. >> what percentage of drugs on the american market are generics? speenine the one that i think is most important is how many scriptures have filled at the pharmacy. in 1960 less than 10% of prescriptions are filled generically in the american pharmacy. a 2014 comments more than 84% of prescriptions. so this is a seismic shift in the nature of the pharmaceutical marketplace. along with that shift, a paradoxical shift that came along is advocating this competitive small manufacturer non-monopolistic generic's place

where these small mom-and-pop competitive wellspring of american businesses. but if you look at the generic industry in 2014, it dominated by a few very large players. sandoz, my lan, canada. and these are not local companies. they are not little farmout opposed to big pharma. they are as multinational as any other brand-name pharmaceutical company. part of understanding the history of generics is the transformation that has been in the sector and often they treat as if they are somehow a small firm compared to big. we need to recognize they are globalized. the generic giants are increasingly a reality of the pharmaceutical marketplace. >> are people going into their doctors because of advertising on tv is saying i want that drug, with a specific name?

>> yes, most definitely. >> has that been helpful to pharmaceutical companies? i'm glad you bring us that because consumer advertising is very important actually to the structure of this conversation. it is part of why i have an historian and drawn to this project. when i entered medical school, my first or in medical 97 in that year as you might remember was the year the fda changed its regulations regarding broad cast advertising for prescription drugs. but the kinks haven't been fully worked out at that point. your might remember the advertising for claritin, which was heavily marketed at the time. it was really brand-new at the time. but the ads were segmented and had a giant clear sky and the

words claritin written across it with no description at all. others described the medications for allergies. see your doctor about it. it's certainly a thing made my way through medical school those kinks have been worked out in prescription drug advertising for brand-name drugs was seen in dysfunction drugs were becoming increasingly common. so at this point, several decades later, we are now somewhat dear to the presence of direct to consumer advertising. at the time it was really shocking to see how dominant the brand's name was and how the pharmaceutical market ways. i came in thinking here is this brand-name, which is part of the marketplace and here is when i learned in medical school, which is the generic name. the generic name as a scientific thing. it is something somehow related to the use value rather than the exchange value of the drug.

that dichotomy is thinking of the brand-name drug is somehow a thing of the marketplace, the generic drug is of science with many of my classmates many professors in medical school as well. one of the things i began to encounter doing research for my first book was he didn't always line up beside. the generic name was not something made of pure science and it wasn't sent them that was universally there. the generic drug companies had their own market interest and were mouthpieces vis-à-vis the fda. as i found my way into archives and i was lucky enough to a freedom of information request to the fda to give access to and from the son of companies began to realize the statement i said earlier which is the generic drug industry was not something that was a creature of pure science or merely a hand need

public house but innovative 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 did what i found however is not what i expected to find. it was a complex industry in the making, one that is poorly understood and as it becomes increasingly important to the fabric of the american help care, really deserves more scrutiny and more understanding. >> dr. greene, how do insurance companies and health care laws treat generics? >> so, this is a very important question. i'll back up for a moment. the way i approach a book is through three part structure. generics are in some ways the most commodified aspect of the health care system. the medicine should be merely interchangeable, marketed on the basis to say this. i became interested in how generic drugs represent the

ultimate modification, how that commodity produced, so when does the generic drug in a straight come into being, how are generic turks made? how do they circulate? what are the sciences that allow regulators to call generic drugs as same as the brand-name counterparts and what are the last incentive structures that encourage physicians to use generic drugs. finally, what does it mean to consumer generic drug. what forms of assistance have emerged, both among consumers and amongst physicians who in many ways actually are immediate consumers of generic drugs. ..

there's legal structures. you may know that i the 1960s most states pass anti-substitution lossmaking as illegal for pharmacispharmacis ts to substitute engineereengineere d for branding as a was for them to put the name of the drug on the bottle. by the '70s and 80s those laws were all over turn everyplace with substitution laws which mandated farmer to to substitute generic drugs are brand named drugs.

there's a legal substitution. it's complemented by a private-sector interest structure which begins to realize cost of savings in emphasizing generic drugs. i don't mean to cast as the villains are problematic structure. i think that these forms of cost savings have been incredibly important to hoping keep our health system viable to the sense that is viable. gilad out increasingly bloated health care expenses are. how untenable the continued growth of health expenditures are your generic drugs appear as an incredibly rare success story in the set of otherwise sales tend to rein in health care cost in health care possible delivery equivalent quality care. but these structures, they begin to become more and more evident and how medicine is practiced and how consumers feel their

ability or inability to pursue therapeutic strategies when you're at the pharmacy. i think one way in which we see it increasingly is moving beyond the structure of generic substitution where i will pay for you to have this molecule be put in your body but only at the generic price. so i will reimburse the generic version but not the brain. you can buy the brand but you won't pay for. therapeutics structure, and ensure will say sure you have high cholesterol and you should be on a step in, but their eight in the american market right now and i am not going to reimburse -- were not going to reimburse you to take this most expensive staten that is not generically available. we will reimburse you the price of a different molecule which is the same kind of drug which is available more cheaply. this practice of therapeutic substitution sorcerer policies that takes generic substitute as a model but extended into the

realm in which one drug can be substituted for another. in some way that's not a problem. for example, if you have allergies and and ensure suggest they will reimburse you for clinton but not zyrtec some people might demand to zyrtec instead of claritin but most of the literature suggests there's not much of a difference between those two. it gets more complicated in arenas like cardiovascular therapeutics for cancer care for example, where these contests, what it means to call two different drugs equivalent or exchangeable if one is cheaper than the other. these are still playing out in america today. >> have you as your personal physician had fights with insurance companies over generics? >> yes. although the fights i've had have not had to do with generic substitution nearly as much as therapeutic substitution. one of the ways in which

insurers have built the structure that help to instant cheaper drugs over other drugs -- incent. to never directly telling physicians that they can't prescribe a drug. but increasing the amount of work a physician must do to get the drug approved for a vision. is something called a prior approval, for example, one path without all the bureaucratic radicals that one finds in the structure. prior authorization means that in order to have a patient of mine can access forget this a drug reimbursed, i need to fill out a set of forms or spent time on a telephone and convince someone on the other end of the line that the patient's needs warrants this exceptional case of using this medicine. i do think it's important that