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Trillions of dollars have been estimated to have been saved because the cheaper generic drugs but as that has been a problem over many years that we want them to be the same with very detailed structures but yet they are never exactly the same look at the network that circulates through the Health Care System the proof guarantees similarity for example, it would be ahead different color a different price or a different manufacturer but the similarities and deer creek the whole infrastructure suggest those differences are trivial. Yet historically how we overlearned that our trivial it is fascinating in many ways with the chemical compounds of that effect is to save as the name brand . I cannot go one day without describing a generic drug. But we realize that we believe the therapeutics from a molecular level that that molecule works in the way we hope it to kick your but as melos give more detail it is more than just a molecule with the suspended elixir and there are differences in the things but i can give you an example one of those blockbuster girls to go off patent in the 60s was an antibiotic that the time it was about to expire newspapers would report what would happen if it expired from generic competition. All of them had this same amount in each capsule but yet some of them had this a moment amount that came out the other and molecular the there the same been but it was not but its with that chemical tests equivalent there is Something Else at stake sunday that was from the different versions and that affected if it worked with the human body so what became a fascinating in the course of researching the steady it can never just be reduced to a molecule alone and out with it is in the subject of regulation and concern of politics and what is at stake and what changes over time. Host how did generics develop . Is a late 20th century to find imitation in store copies but i became interested in rise of said generic drug after a zero wave of development in the middle of the 20th century. But those companies that become the Research Based pharmaceutical industry known as the ethical drug manufacturer. They all made effectively the same drug they guarantee to make the drugs ethically and advertise responsibly to tell you what was in the bottle its not leader until the 20th century the american system developed a way the Research Laboratory becomes important and and the patent to protect its molecule so the emergence that was a burst of Innovative Pharmaceuticals c. C. That developed in the 60s or 70s soul opening of generic competition. Host what are the patmos . Patent laws . They are not that different but they have a 17 your protection that could be extended at 20 years and during that time part of the bargain that is made that the innovator discloses but they are granted a monopoly as a reward for innovation. But they generate a certain type of monopoly and have been since the wake of those this pharmaceutical companies that have developed these drugs to give them brand names began to extend the monopoly into trademarks. Said then that they have very highly visible patterns if tariffs are as good as a brand name the ministry is evident with the ability to extend that monopoly is important at the same time it doesnt mean that they are not the same or just a form of marketing. So there is a clash that dopers that goes off patent where manufacturers insist they should still use the brand name version and cannot trust the generic version five and eight cannot be trusted where of as consumer advocates they insist they are exchangeable to save the Health Care System lot of money. So there is a clash that takes place over a series of congressional hearings and as a historian it is fascinating to realize it isnt the same over time but represent said dialectic space between these two interest in which this similarities form along the way. Congress played a substantial role if you look at the senator from tennessee a populist interested to advocate consumer politics, he believed he was chairman of the subcommittee is and he thought that pharmaceutical industry was the ideal test case to eliminate the broader problems of society partly because he thought the consumer was the most captive and had no choice the doctor write the of prescription and the patients it takes it to the pharmacy and then you have to buy it. And then to explode this problem but keith thought he could rescue the consumer from the captive status by enforcing the generic names and he wanted to pass legislation to completely eliminate brand names from the pharmaceutical marketplace make them only available by generics. I have a prop from 1960. This bottle came from the bay and if you look at the label quick and read what is on edge. Blood is present and what is not . With that political power . In a game from clients pharmacy and. I believe that is in illinois. Host one tablet before each meal dr. Cannell walt and at that time and at bedtime. Guest that is striking what was not of there. The name of the madison . It is used as directed but there is no name and it is shocking. Most of my colleagues no one had described the the name of the drug so i began to look at the problem not until 70s pharmacists are required to put the name on the bottle. So talkedabout the captive consumer so let alone to shop around. So to say it might be time for us to encourage pharmacists to put the names on the labels. It was considered unethical and illegal to do tell patients the name of their drugs without express written permission. So they had physicians to say if you tell patients what is in the bottle you will destroy the basis of the doctor patient relationship. There is a couple of arguments and one is mitt you tell patients what is in the bottle they cannot have a placebo so they are still actively prescribing placebos in the time of this bottle. Illustrate something powerful that is a paternalistic model re a physician would go it is a common practice so that would make the patient do worse. So it is not just a conspiratorial scheme but also fundamentally different ethical set of precepts over time. Of course, it is dramatically different with the medical information is ours and they have no right to hold the information from us but my colleague said history basically i am a journalist working in the 20th century sometimes i hold in this example up one can witness such a radical shift in the cultural approaches to the body also to show the power of the name with said uc those and simply change the brand name make it visible to consumers to transform the nature to empower every day americans. Host there is the counter argument eli lilly has put all the money into research to find a cure to problem x they should have the right to market and sell that product. Certainly. To have no shortage of representatives lookit the way policy has been written this is the basis which. We granted passage do innovators during that time period and generic drugs come after that period of the anomaly. One of the things that helped me along is we have come to except as is natural of a twopart life cycle approach the Innovative Company with eli lilly or pfizer and that is why they grant the past. And it is that the cost of access at the end of the monopoly behalf of pathway for generic competition we can assume more competitors will come in the price will come down then we reach the affordable level to emphasize access over innovation and. With a twostage life cycle is partly the result of the broad handshake agreement that help to extend patons for innovative drug makers at the same time make a pathway for generic competition. One of the problems it is not natural at all. Up something they have created through a regulatory structures the very much a product of human enterprise. And then the third stage is what happens when those strokes that our off patent that our no longer so exciting to the generic manufacturers to make reassume the free market so lucky as having three stages but at which point it is a generic pipeline as they compete with one another to be the first to make it. That when it is not a part of foul a company will diversify in the future. It is not just an abstract exercise but we have noticed in the past five years that a number of essential to the eric medications there is a bottleneck and one in this is a very basic antibiotic from 1967 that is useful of general medicine practice when i was going to run medical residency with the Infectious Diseases we would talk about what they should use his civvies heavily advertised drug and it is just as useful but a think when i looked in october is 20 but of 500 count this october cost nearly 1,800. To understand how that price hike can happen in a medicine that is off patent several decades requires that the generic market place is competitive that is geared toward innovation and self looking for word to use the new drugs haul that they can make a higher price margin and is leading edge can be neglected so this is part of what led me into the book itself that we have the solutions of the generic market place we think of it as an algorithm here is so wonderful industry to help make drugs accessible in contrast to big pharma that has high prices rewarded for innovation but yet it is not moral or immoral and will pursue its own interest and sometimes that passed to create devastating problems. What percentage of drugs are generic . To make there are different ways. The one i think is most important is how many prescriptions are filled at the pharmacy was the 10 in 60s were filled generically by 2014 it is more than 84 . Is a Seismic Shift for the marketplace but there is that paradoxical shift as day advocate this competitive small manufacturers non monopolies marketplace he thinks of firm says the small momandpop competitive wellspring of American Business the look at that industry is dominated by a few large players in these are not local companies are little pharmaceutical there just as beguin multinational as any other. So part of understanding the history is the transformation but we treat generic sometimes that we need to recognize they are globalized generic giants are increasing a reality from the physical market place we know today. Host are people going to the doctor because of advertising on television because of a specific name . Guest most definitely. Host is that helpful to pharmaceutical companies . Guest im glad you bring this up to directing Consumer Advertising is very important to the conversation why as a physician to a common the project firstyear medical school was 8097 and that year was the year that the fda changed the regulations regarding the broadcast advertising and direct to consumers but the kinks were not worked out at that point you may remember clearer than which was heavily marketed at the time that the ads were segmented they had a giant clear sky with the word claritin then say ed new allergy medicine by the end of the year as it made my way through medical school the kinks were worked out. And a Prescription Drug and i am learning in medical school that one of the things is shared by my classmates or professors that i began to encounter doing research is it did not always wind up this way that it was not pure science over universal but the companies had their own interest and were malfeasance players and as i found my way into the archives and was lucky through the freedom of information request to gain access to all letters to and from begin to realize is the generic drug industry was not a creature appears science but a complex self motivated industries though it was my own conception of the power of the brand that drove me to study the generic but that is not what i expected to find i found a complex industry in the making for the understood as it becomes increasingly important it deserves more scrutiny and understanding. Host how do Insurance Companies and Health Care Laws treat generics . This is a very important question and the way i approached the book is a three part structure generic could be the most modified aspect to be interchangeable but i was interested in how generic drugs represent the ultimate commodity as it is produced when does it come into being how do they make it and how do they circulate . What science allows regulators and what are the laws that encourage patients and physicians to use generic drugs and what does it mean to consume a generic drug among consumers and physicians your immediate consumers themselves such a task in particular is a very important key of this book one of the reasons they are so widely used today because the broad bureaucratic system that helps to decide which madison will pay for effective least years our behavior in this is an edifice that had to be built over time but no insurance tells a physician with the carter could not prescribe it it took zero lot of work from that constrained abilities to shake the consumer to take shape as legal structures by the 1960s most past antisubstitution of laws to make it as a legal to substitute of brand name as it was to put it on the bottle by the 80s there all overturn a and then they replaced with a mandate drug so it is of legal system with this practice complemented by a private sector insurance structure that begins to realize cost savings to advertise the generic drugs that isnt to a problematic structure as these forms of cost savings have been incredibly important to keep the Health System of viable lucky and at increasingly bloated Health Care Expenses are generic drugs appear as a rare Success Story in a set of failed attempts to rein in the Health Care Cost of delivering equivalent quality care. But the structures begin to become more evident how medicine is practiced in how consumers feel their ability to have their strategies that the pharmacy reseed moving beyond the structure where i will pay for you to have this bill in your body but only at the generic price. I will reimburse the generic version but not the brand but to a structure that is now therapeutic substitution that they will say you have high cholesterol but there are eight in the American Market right now it i will not reimburse you to take this most expensive one prewill reimburse a different molecule so this practice of therapeutic substitution is that takes them as the model extending it were one drug could be substituted for another. For example, if you have allergies they will reimburse for one another they demand bet most literature suggest there is not much of the difference but it gets more complicated with therapeutic sort cancer care where what it means to have two different drugs equivalent or exchangeable said the is still playing in america today. Had you had fights with Insurance Companies over generics . Yes although those fights to not have to do with the substitution of generic as therapeutic. One of the ways in which ranchers have built a structure over other drugs is to never direct tell physicians they cannot prescribe a drug but increase the amount of work to get the drug approved so there is prior approval fear is one path laid down the of bureaucratic of what they find in the structure of prior authorization means that in order to have the patient get the drug reimbursed i need to fill out the forms or spend time to convince someone on the other end that the patient is an absolute case but it is the path of these resistance so with that structure to do what they would like which is the rational course of a cheesy achieving cost savings but as the patient remember its there to be a time for opposition and resend and rationalization that dr. Strange love arrives by a a set of steps but to think the rational system could have a reasonable results for is a dilemma that exist at the heart of medicine but when something has been vetted by the fda to be equivalent is not equivalent of a bodily experience could this may not follow that rationality. John hopkins professor of medicine, dr. Green is the author of this book generic. Thank you for your time. Host introducing new to the book macaws medicaid is the cosmetic gays. What a role here Johns Hopkins . In Us Department of literature i created to direct a center for trans media studies and we curate artist in residence to bring in topics ahead declined anything that is culturally importance whether video installation or other art pieces that are usually informed by the image which is the idea of media. Other than that i teach to class is which is great because it gives me time to write books and make films which is what my work is all about. Host how does this

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