“The Same Thing in a Different Box”: Similarity and Difference in Pharmaceutical Sex Hormone Consumption and Marketing


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“The Same Thing in a Different Box”: Similarity and Difference in Pharmaceutical Sex Hormone Consumption and Marketing
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Medical Anthropology Quarterly (MAQ).
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Sanabria, Emilia
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The pill


The contraceptive pill has given way to a multitude of products, packaging, and modes of administration. This article draws on work on the pharmaceutical copy, extending the analysis to differentiating between forms of administration for contraceptive medicines as well as between brand-name drugs, generics, and similares, as they are known in Brazil. It explores how Brazilian prescribers and users—within the divergent structural constraints afforded by private and public health—apprehend and negotiate distinctions between the drugs available to them. This ethnographic account of hormone use reveals new fault lines through which the pharmakon exerts it influence. The attention that industry places on pharmacodynamics as it produces new products from similar compounds suggests that pharmaceutical effects are at once symbolic and real. The article concludes with a reflection on the future of the generic form in a field increasingly crowded by branded copies.
Collected for University of Florida's Institutional Repository by the UFIR Self-Submittal tool. Submitted by Yasemin Akdas.
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! Emilia Sanabria Ecole normale sup Ž rieure de Lyon Laboratoire Triangle & INSERM, France (E mail: emilia.sanabria@ens lyon.fr) The Same Thing in a Different Box : Similarity and Difference in Pharmaceutical Sex Hormone Consumption and Marketing ##################################################################################################### The contraceptive pill has given way to a multitude of products, packaging and modes of administration. This article draws on work on the pharmaceutical copy, extending the analysis to differentiating between forms of administration for contraceptive medicines as well as between brand name drugs, generics and similares as they are known in Brazil. It explores how Brazilian prescribers and users within the divergent structural constraints afforded by private and pub lic health apprehend and negotiate distinctions between the drugs available to them. This ethnographic account of hormone use reveals new fault lines through which the pharmakon exerts it influence. The attention that industry places on pharmacodynamics as it produces new products from similar compounds suggests that pharmaceutical effects are at once symbolic and real The article concludes with a reflection on the future of the generic form in a field increasingly crowded by branded copies. [contraception pharmaceuticals, generics, the pill, Brazil] ###################################################################### ############################### Introduction The oral contraceptive pill has become a fairly ubiquitous object. So much so that it is known as the pill. Yet behind the apparent unity of this object lies what Mol (2002) would call "multiplicity." This article examines what gives this medical object its unity and analy z es the social and regulatory practices that are at work in the making or unmaking of this uni ty. My concern with how synthetic sex hormones are produced as contraceptives stems fro m an ethnographic conundrum. In study ing the impact of the pill on women's contraceptive practices, one is faced with an array of different objects often lumped togethe r as one. How can a thing like the pill be one and many simultaneously? Why does this object vary so widely? How can we account for its concurrent lability and condition as a tangible, material object? Since its inception in the early 1960s, the pill has given way to a multitude of products, in different forms of packaging and modes of administration. First, there is a profusion of orally administered pills: combination pills (estrogen and progesterone ), mini pills, extended regime pills or emergency pill s, combining any variation of the plethora of synthetical ly produced hormones. These can in turn be brand name drugs produced by international pharmaceutical laboratories or copies of these. This article is based on ethnographic research in Brazil, where a dynamic pha rmaceutical industry specializes in copying what are locally referred to as medicamentos de marca ( brand name medicines ) (Cassier and Corra 2009). Only a small percentage of these copies are registered as generic s" by the Brazilian Agency of Sanitary Vigilance (ANVISA) in charge of pharmacovigilance. The majority of copies currently available in Brazil are classified as similares (lit erally, similar drugs) not generics and it is widely estimated that these represent 65% of the total Brazilian pharmaceutical market. In addition to this profusion of oral forms, contraceptive sex hormones may be injected, implanted subdermally, absorbed through the skin (via transdermal patches or gels), the vagina (via a vaginal ring) o r the uterus (via an


! $ intra uterine hormone releasing system). The making of this multiplicity relates to the search for long acting contraceptive methods for the so called developing world in which Brazilian medical institutions played a significant role. This article explores the dynamic between similarity and difference in pharmaceutical sex hormone marketing and prescription strategies in Brazil. This dynamic hinges on a process of multiplying different consumer populations within complex and shifting b iopolitical rationalities of reproduction (Krause and De Zordo 2012 ; Sanabria 2010 a ). In the late 1980s, Brazil underwent a period of democratic reform in which the "universal" public health system known as the Sistema nico de Saœde ( SUS ) was consolidated T he SUS coexists with a dynamic system of private health to which 20 25% of the Brazilian population subscribes. 1 Many private health institutions provide services for the SUS, sometimes offering a dual standard of care. Health disparities within Brazil are further compounded by important regional variation s in access to services. Access to contraception in Brazil is highly stratified, revealing profound socioeconomic disparities, notably in its reliance on surgical sterilization. Although rates of steril ization declined from 38. 5% of c ontraceptive use in 1996 to 25 % in 2006, significant disparities emerge when analyzing these figures according to level of education or economic class. 2 Non oral h ormonal methods, s uch as contraceptive injections hormonal i mplants or intra uterine hormonal devices like Mirena are specifically pitched by health providers as alternatives to sterilization the rates of which remain uncharacteristically high Pharmacies remain the principle source for hormonal contraceptives, p articularly for those groups at either end of the social spectrum. T o understand the dynamic s around hormonal contraception use, one therefore needs to look beyond the activities in the public health sector and to pay attention to the prescription practices in the private sector and to wha t take place across the counter, in pharmacies. This is a blind spot in much of the literature on contraception in Brazil which, in focusing on women's perceptions or the problem of unmet contraceptive needs overlooks the way contraceptive decision making is also shaped by feedbacks between pharmaceutical promotional strategies and prescription practices or by the dynamics of "switching" that take place within pharmacies. Method s and Setting: Tracking Pharmaceuticals in Salvador da Bahia The ethnographic materials presented here were gathered in Salvador, capital of the n ortheastern state of Bahia, as part of a research project on menstruation, contraception and sexual and repr oductive health practices. This involved 18 months of fieldwork (in 2005 6) during which I attended over 300 family planning consultations across three distinct public sector services and in several private practices. 3 I also conducted over 70 in depth interviews with women across all class es During this period and in four subsequent visits of three to six months between 2008 and 2013, I attended three medical congresses and interviewed doctors, nurses and health plann ers. The repackaging of hormonal contraceptives rapidly emerged as an important methodological concern, so I embarked on ethnographic work in the pharmaceutical sector. I carried out several weeks of fieldwork in three pharmacies catering to low middle and high income neighborhoods and met pharmacy sector regulators and members of pharmacist professional organizations. I interviewed the national marketing directors of four major pharmaceutical corporations in S‹o Paulo (Schering, Pfizer, Libbs and Boeh ringer Ingelheim) and followed the work of Schering's, Libbs' s and Organon's regional managers over the course of several months. I met a number of other pharmaceutical representatives in doctor s waiting rooms, some of who m allowed me to observe their wo rk. 4 Through these


! % contacts, I was invited to several pharmaceutical promotion events (such as conference din n ers and congress e s). Although 90% of drugs are bought out of pocket (Thuot et al 2 012), Brazil is one of the largest consumers of pharmaceutical drugs and the seventh largest market worldwide. A cardiologist cited by Petryna (2009:145) attributes Brazil s "voracious pharmaceutical demand" to aggressive marketing, lack of enforced state regulation, and a bias for brand name drugs. Growth in the pharmaceutical sector is estimated at 13%, partly due to a booming industry of generic copies. This places Brazil among the high growth nations referred to as "pharmerging." Pharmerging markets are characterized by the Institute for Healthcare Informatics by a rapid increase in drug consumption, with a shift in spending away from branded products toward generics (IMS 2011). These shifts are imputed to a synchrony between historically high levels of patent expir ations and improved economic conditions driving demand for drugs, particularly generics ( IMS 2011:3). This points to tremendous tensions between brands and copi es in global pharmaceutical markets. The concept of pharmerging sheds light on how national development, democratization through the extension of citizenship to the global poor and pharmaceutical consumption are imbricated in conceptualizations of the rol e of pharmaceuticals in global development. I n this article, I examine some implications the dynamics of pharmerging markets has on the way drugs are perceived and used in Brazil. I explore how Brazilian prescribers and users within the divergent structura l constraints afforded by private and public health apprehend distinctions between brand name contraceptives, their copies, and their different modes of administration. For this reason, I trace the differences among what is commonly presented as similar an d the similarities that insinuate themselves in things presented as different. This attention to the interplay between similarity and difference takes its inspiration in the work of Hayden (2007, 2010 ) on the pharmaceutic al copy, extending the analysis to the work of making difference and similarity between forms of administration for hormonal contraceptive methods Interchangeability : How Different Things Are Made Similar Throughout the 1960 70s, and under the military dictatorship of Getœlio Vargas the Brazilian state adopted an explicitly pronatalist stance. The absence of a national family planning strategy created a void. Corra (2001:56) argues that the "medicalization of reproduction" in Brazil was led by private sector initiatives, often contr ary to the official state position. This resulted in a contraceptive praxis characteri z ed by drugstore promoted self medication that gradually le a d s women to turn to sterili z ation. Mapping the history of the pill's uptake in Brazil is difficult because it was not introduced as part of a planned public policy (Loyola 2010 ; Pedro 2003). Enovid, the first pill to be introduced in Brazil, was promoted by salespersons in private gynecological practices and available in pharmacies, although its cost was prohibiti ve for most (Pedro 2003). The pill was unevenly diffused among low income women by the interventions of international non governmental organi z ations. The first state program to include family planning was launched in 1977. In her oral history of the pill i n Brazil, Pedro (2003) found that women recollected experiencing many discomforts with the pill, a fact mirrored in the media coverage that emphasi z ed, from the outset, the risks and side effects of the initially highly dosed pills. Contraceptive choice i s a foundational aspect of reproductive and sexual rights. Hartman (1995) argues that population control programs impose birth control from above limiting choice of methods. Against this, she pitches reproductive health programs that offer a wide range of methods and access to safe abortion ( Hartman 1995: 57 ). The distinction is more heuristic than descriptive as elements of both ideal types exist in the day to day


! & practices of reproductive health services worldwide. However, it illustrates the rhetorical importance of contraceptive method diversity in reproductive health. M y aim is to highlight the ways in which this contribute s to construct ing a f orm of interchangeability between contraceptive methods and between hormonal methods in particular. This permutability between methods opens up the first notion of simil arity between medicines that I would like to highlight. The logic of choice that permea tes these contexts implies that women select from a range of similar options. In the context of promoting choice, differences between methods are temporarily bracketed as an emphasis is placed on finding the most suitable method among what is essentially foregrounded as equivalent choices. In Bahian public ambulat—rios (out patient clinics) it is common for choice to be limited by a lack of methods. The methods available in the family planning units I researched tended to include one or two types of oral contraceptive pills, hormonal injections and copper intra uterine devices In these contexts, where the average consultation with the doctor is seldom longer than five minutes, women w ho express difficulties with a particular pill or want to change methods are given whatever else is available. Public ambulat—rios generally administer pills by packs of three, and pill users often return to find that the pill they have been using is no lo nger available. This renders whatever else is available interchangeable, by default, inverting the logic of choice into a logic of necessity, of sorts. In these public services, teenage girls ar e often proposed the injection in place of the pill when it i s available One doctor I interviewed justified this as follows: "The inj ectable is much more effective [ ] T hat way, we know for sure the patient won't get pregnant and that we are not wasting resources." Injectable contraceptives are pitched as a reliable alternative to the pill for young women who are considered esquecidas (forgetful). In Salvador, much attention is given to the risky sexual practices of teenage girls leading to unwanted pregnancy (see Marinho et al 2009). Although injections are barely represented in the available 2006 population wide data on contraceptive use (PerpŽtuo and Wong 2009) I found that this was often the second or third most delivered method in the public health posts in which I carried out observation s. 5 Oudshoorn's (1996, 1997) historical work on hormonal contraception provides a context to understand the dynamic of interchangeability that I am foregrounding here. She traces the gradual demise of the "One Size Fits All" approach to contraception promoted by early developers of the pill ( Oudshoorn 1996). This led to the development of a "cafeteria model" of hormonal contraceptive diversity. 6 In the late 1970s, the WHO actively promoted research on long acting hormonal contraceptives (hormonal injec tions and implants, in particular). These were seen as efficacious tools for population control programs because they are provider administered. This makes them good technical delegates, that is, artifacts that are "designed to compensate for the perceiv ed deficiencies of [their] users," such as women's tendencies to forget to take the ir pills daily (Oudshoorn 1997: 44). The WHO R&D program stemmed from the recognition that "the pill had only been taken up by "middle and upper class women in the western industrialized world" and not by women "in Southern countries" (Oudshoorn 1997:43). Injectable contraceptives such as Depo Provera are described by the WHO team in a Science publication as "appropriate in developing countries but of relatively little inter est in highly developed ones" (CrabbŽ et al 1980 ). 7 Technologies such as the pill contain a configured user (Oudshoorn 1996) that can inhibit its capacity to enter into new sociopolitical contexts. For the pill to travel, it needed to be unpacked. Its circulation depended on making the object more fluid, so to speak (de Laet and Mol 2000). As new objects were produced from sex hormones, their circulation worked to differentiate between different cons umer populations. This background is important for understanding how choices are presented in public family planning institutions in Bahia. Low income patients tend to be perceived as


! ignorant or inconsistent and although birth rates have decreased signi ficantly in Brazil, relations between unbridled fertility, underdevelopment and poverty continue to be commonly drawn in popular imaginaries. Just as the pill and the injection are often rendered interchangeable, pills are readily swapped for each other. The work of choosing from the huge array of available pills is an exercise in differentiating between similar things. This work is heavily influenced by the active work of pharmaceutical representatives who strive to differentiate their products. One morni ng I sat with a gynecologist in a maternity unit in a small town near Salvador where private and public consultations were held back to back, in the same space. A young woman came in from the list of public service patients. She discussed contraceptive opt ions with the doctor, showing herself to be knowledgeable of different hormones and using the space to air queries about side effects. Although the young woman was not a paying patient it was clear she did not want to be administered the standard pill ava ilable in the health post. She asked about the vaginal ring that she had heard about from her cousin and about the difference between the mini pill and Ciclo21 (a popular Brazilian copy of Schering's Microvlar ). They discussed Yasmin "an excellent option," the d octor declared, but "very expensive." T hey settled on Levell and the d octor advis ed : "See how you get on with this. Take it every day at the same hour. And we'll explore until we find the right one for you ." T he production of di fference in such context s is attendant on a prior notion of similarity that makes interchangeability possible. T his notion of similarity is essentially analytical. Part of the ambiguity arises from the way contraceptive methods are classified. Most classif ications blur use and mode of action. Contraceptive methods can be "barrier," "behavioral," "permanent," "emergen cy," or "long acting reversible and Brazilian categories until recently distinguished between "modern" and "traditional" methods. Popular categories tend to group methods according to their mode of administration rather than mode of action (thus differentiating between oral, injectable or intra uterine methods, across which hormonal methods are spread). While not everything is constructed a s the same thing, and differences are produced between methods, my point is that the logic of interchangeability functions to smooth out differences between methods in the context of producing contraceptive choice. In the following section, I examine how o stensibly similar medicines may nevertheless be treated as radically different things revealing how strategic the suspension of differences or the emphasis on similarity and interchangeability can be. Sma ll Gaps, Big Differences H istorian Watkins (2 012) argues that there is nothing innovative about the purportedly new hormonal methods currently available on the market. Their sole novelty she argues, resides in the marketing of the secondary, or lifestyle, effects of sex hormones Watkins traces th e tactics for "tin kering" with the pill's design, arguing that pharmaceutical companies promote d distinctive aspects of what were essentially similar products" (2012:1465). The introduction of slight variation supplants genuine innovation with mere imitatio n (Watkins 2012:1465) Interestingly, Watkins dwells less on the development of new modes of administration, concluding that the contraceptive options available to women today hardly differ from those available to their grandmothers (Watkins 2012:1464). This reveals how Watkins constructs the notion of similarity. Her notion of "hardly different" hinges on the similarity of the active principles themselves. She shows the extent to which sex hormo ne marketing hinges on demonstrating differences with in non contraceptive properties of "new" products. However, her analysis risk s overlooking the way in which, in practice, marketing produces very different things Small innovations produce big differenc es for users and prescribers alike.


! ( T here is perhaps nothing new to the levon orgestrel compounds used in Norplant implant s the Mirena intra uterine hormone releasing system or emergency co ntraceptive Plan B However, these are so different in the minds of the women, doctors and pharmacists I interviewed that they do not even enter a common category. Yolanda is a tall, enthusiastic woman in her late twenties We met one day in the waiting room of a private clinic, whe re a gyn aecologist wa s running two hours late. Yolanda wears the characteristic smart office garb of pharmaceutical representatives and has a black attachŽ case full, I imagine, of amostras (free samples). She is a pharmaceutical representative for Nuvaring and is zealous about this "completely novel approach" to contraception. Nuvaring is a small silicon ring inserted in the vagina once a month. Yolanda explains to me that private practice doctors are enthusiastic about Nuvaring but have come up aga inst "taboos" in prescribing this method. Yolanda pulls a three dimensi on al plastic model of the female reproductive organs out of her attachŽ case explaining that she gives one to each doctor so they can educate their patients about the vagina, showing them how and where to insert Nuvaring "Although we live in a very sexualized culture here in Brazil," she explains, "women don't know their own anatomy and have very traditional ide as still." Organon Brasil actively works on this sexual trope in its marketing strategies. Yolanda enthusiastically recounts an event she recently held in a sex shop for a group of female gynecologists. The objective, she explains, is for the gynecologist to become a purveyor of information about pleasure and sexuality and to have access to new ideas and information in this respect. 8 The doctors she visits feel that their patients are not ready for this new approach to contraception. As one female gynecolog ist I interviewed explained: Nuvaring is such a lovely method. But women have all sorts of preconceptions about it. That they will lose it in their vagina, or that their husbands will feel it. You have to explain that the vagina is a closed cavity, that N uvaring can' t be felt, and then you still have to get them to overcome their hang ups about putting their hand in their vagina. In the process of expanding contraceptive choices to patients, Nuvaring appears as something radically different for caregivers This dispenser mechanism may have been experimented with for over 40 years and contain entirely un innovative steroid compounds, but as it is taken up by users, this object arises as a markedly different thing. The logistics of its use (inserted for thre e weeks, removed and then reinserted one week later) and the locale of application (the vagina) contribute to rendering the similar aspects (to the pill) almost negligible. Depending on the perspective adopted, this object a ppears as either just the same old thing in new garb (Watkins 2012) or as radically different. These differences may seem so considerable to end users that it causes them to lose sight altogether of the fact that they are using a hormonal contraceptive method. M any of the women who use the hormone releasing Mirena intra uterine device or hormonal implants opt for these methods precisely because they do not like the pill. While hormonal injections remain closely associated to and interchangeable with the pill Mir ena and implants have come to be perceived by users as unrelated to the pill. Nara runs a small business and has been using Mirena for two years. She is 29 and has a four year old daughter who lives with her and her parents in a modern high rise building. As a busy working mother, Nara appreciates not having to think about contraception daily. Her contraceptive history is marked by what she calls an "erratic" use of the pill. Her pr egnancy was unplanned and after an abortion three years later, she used a copper IUD. This gave her painful and heavy periods and she became aware of having what she describes


! ) as "tremendous" premenstrual tension. Her gynecologist suggested Mirena which is often prescribed in such cases and her partner helped her meet the cost which amounted to over US$250. Nara explains that she never "got on" well with hormones, although Mirena has a hormonal delivery system and that she enjoys the fact that Mirena suppresses her period. When I press her on this she laughs, stating: I t's totally different." This can be explained by the fact that Nara adopted Mirena specifically as an alternative to the pill: "I went for it as an anticoncepcional (contraceptive), to be free to travel and everything without having to depend on a pill. And I got on well with it. And on top of everything, I stopped menstruating, then I was really loving it. I recommend it to everyone." Likewise, Simone has been using hormonal implants for six years because she dislikes the pill. She is a professional photographer and runs a large events business. We met through mutual friends and she and her husband, Carlos Eduardo (Cadu) humorously agreed to an interview because they were "in the mid dle of a family planning crisis," debating whether or not to have a third child. Their first child was conceived while Simone was us ing the IUD, less than a year into their relationship. Simone adopted the implant after their second child because of its co ntraceptive reliability. Cadu they both joked one evening over di n ner loved the implants because, they agreed, Simone was "infernal" when she menstruated. Simone who is vegan, a yogi, and makes use of a range of holistic therapies, such as Reiki explains that she never uses medications and prefers to heal herself through meditation or by attending to the meaning that a particular physical ailment is conveying. She speaks of loving her implants in terms of a "confession," explaining that they give her tremendous "disposition" for life but that she worries about what it might be doing to my organism. I love it, but I'm scared of using another one." S imone recognizes the hormonal composition of her implants and its risks, and appreciates the effects of t he testosterone that heightens her tes‹o (sexual desire) and gives her extra physical strength, but she clearly differentiates the implant from the pill which she notes is more highly dosed or the morning after pill that she describes as a "hormonal bomb." Beyond its practicality as a contraceptive, this method appears to Simone as less of a biomedical intervention in that she does not have to take a pill every day, a fact that sits more easily with her holistic vision of health. However, it enables her to sustain her demanding lifestyle and meet her professional and social obligations unencumbered by what she calls "emotional disruptions" or "menstrual fraqueza (weakness)." How to account for the fact that so many hormonal implant and Mirena users I interv iewed explicitly rejected any association between these and the pill? 9 Modifications in the mode of administration induce changes in the perception and experience brought about by the object that may be so significant that they eclipse the common hormonal action between two drugs. To some extent, biomedical technologies such as Mirena or hormonal implants cease to appear as drugs, despite their pharmacological action. Marketing for Mirena somewhat downplays its hormonal action drawing attention to the fact that it is an intra uterine device. It is therefore understandable that this method is less associated with its hormonal action. However hormonal implants are widely appreciated for their menstrual suppressive action, and muc h of the promotion made of this method centers on controlling the hormonal fluxes associated with premenstrual tension The implants are marketed as making possible a kind of hormonal enhancement that, according to some gynecologists enabl e s a form of se xual enhancement captured by the idiom of having disposi‹o (disposition) by adducing exogenous testosterone or estrogen 10 Beyond facilitating use and overcoming forgetfulness, non oral sex hormone repackaging strategies bear directly on the bioavailability of an active principle in the body. When a drug is swallowed and absorbed by the digestive system, it is metabolized by the liver. This reduces the bioavailability of the drug, requiring the administration of a higher


! dose. Alternative rout es of administration avoid so called first pass effects through their delivery directly into the circulatory system. Differences of these kinds have important ramifications on the way an otherwise similar chemical compound acts in the body. User s subjecti ve experience s of a drug's efficacy are thus mediated by a range of factors that include its active principle, its mode of administration which in turn determines the drug's pharmacokinetics and the symbolic and social context within which it is prescrib ed and consumed. Recent work in pharmaceutical anthropology (e.g. Schlosser and Ninnemann 2012) calls for the need to understand pharmaceutical efficacy in relation to the biological, sociological and structural factors that shape individual responses to drugs. The cases discussed here reveal new fault lines through which the pharmakon exerts it s influence, collapsing the distinctions between biological and sociological factors. The attention the industry places on pharmacodynamics suggests ways in which effects are both biological and social, symbolic and experienced in the flesh. In repeatedly a lluding to differences in the effects of non oral methods, these women are speaking at one and the same time of differences in the rates and magnitudes of pharmacologic responses, in the quotidian practices of use and in the medical encounters where these method are prescribed as well as ensuing differences in the subjective identities locally conferred by "having an implant" or "using Mirena ." These cases reveal how different the same thing repackaged can look and feel They point to what can be gained b y considering pharmaceutical efficacy as the cumulative effect of the reputation, appearance or subjective attachments to specific drugs, to their brands, pharmaceutical formulations and modes of administration as well as to the social contexts within wh ich drugs are used. The production of difference or the demonstration of simil arity hinges on the enrollment of an intricate meshing of chemical, structural, economic and semiotic elements. In this sense, the pharmaceutical effects I am underscoring here are prime examples of what Haraway (1991:200) calls "material semiotic" nodes. Pharmaceutical Copies a nd Substitutions: Differentiating t he Similar Given that roughly 75% of all hormonal contraceptives are obtained directly in pharmacies, often without prescription, these became privileged ethnographic sites. 11 My observations in Bahian pharmacies allowed me to witness the practices of pharmaceutical substitution that commonly take place over the counter Typically, clients arrive requesting a sp ecific drug they have been prescribed or recommended or that they have failed to obtain in their local health post. It is common for the balconista (shop vendor) to answer that the drug is unavailable and add: "But we have the similar. It's the same thing. If the client is hesitant, the balconista may call attention to the similarity in the composition of the drug being offer ed adding "and it's cheaper." Similares often cost a fraction of the price of brand name drugs. When clients inquire as to the signi ficant price difference, balconistas may explain this by saying that brand name drugs are imported whil e similares are "national products." Brand name drugs have a certain prestige to them, like other imported goods Imported goods such as grifes (designer goods), cosmetics, electro domestic appliances or electronics bring with them the social attributes of the elites who have access to them so consuming them becomes a means of accessing elite status (Yaccoub 2011). Differences between imported brand name drugs and similares are often presented by balconista s as one of packaging or origin, whil e the likeness between active principles is emphasized. Similares are usually promoted directly to pharmacies rather than to d octors. Several informants estimated that balconistas earn commissions of up to 50% on each box of similares they sell. This practice encourages balconistas to substitute brand


! + name medicines with similares Given that Brazilians buy drugs out of pocket, t he similar marketing strategy is extremely efficient and explains why more than half of drugs sold in Brazil are estimated to be similares This has become a major sticking point, particularly as few pharmacies operate with a trained pharmacist. A lthough t his wa s formerly illegal, pharmacy owners prefer paying fines to paying full time pharmacists. In practice, in Bahia, pharmacists often "rent" their names to a pharmacy while working full time jobs in laboratories (Kamat and Nichter [ 1998 ] relate a similar situation in India) Despite recent efforts to levy fines more regularly, it is still rare to find a pharmacist beh ind the counter in Salvador. This is often seen as facilitating sel f medication. 12 During an interview, the p resid ent of Ba hia's Pharmacy Council joked: "Even my own mother se receita (prescribes herself) and receita others in the family, so what can we do?" Almost anything is available without prescription in pharmacies (despite clear indications to the contrary on prescripti on drug packages), facilitating prescriptive forms of sociability, where people exchange information informally about the medicinal regimens they obtain directly, and often without prescription, in pharmacies. Schering's regional representative, Anderson a jovial and seductive father of two in his mid thirties took me out on several occasions "to visit his gynecologists." The private practices in Anderson's clientele are luxurious, their interior design mixing white marble floors, spotless glass doors and colorful popular art. Each consul t—rio has its own "look and the predominantly female doctors wear pastel colored lab coats with their first names embroidered in bright colors. Schering's products are considered muito chique (very chic) as one gynecologist put it. On one occasion, Ande rson and I ra n into a group of representatives, identifiable by their matching black attachŽ cases. Vinicius, a representative from a Brazilian laboratory approache d me while Anderson wa s talking loudly on his flashy cell phone to ask me if I'm a rep too. He seems new to the scene and full of zeal. Anderson has snubbed him, but Vinicius tells me : "He's one of the best, his sales figures are unmatchable." When the gynecologist calls the reps in, we go in together, to save her time. Vinicius b egins, nervous, mechanically reciting his pitch and laying down a large batch of amostras that the gynecologist silently slips into a drawer in her desk. "This guy is just a distribuidor de caixinhas (a pill pack distributor) Anderson whispers to me, "his lab pushes quantity over quality of encounters." When it is his turn, Anderson engages in conversation with the doctor as an equal, taking his time, making a few jokes. He knows his products matter here. The doctor is m ore patient with him, his good s holding g reater appeal. When the other reps have slipped out, thanking the doctor for h er time, Anderson launches into his pitch for Yasmin He is concerned because Libbs, a Brazilian similar laboratory is launching a copy of Yasmin called Elan’ Doctora I want you to help me make Yasmin the number one option for your patients. It's the best product on the market: I t's about your patient's well being. She won't experience that swelling that makes her swap. And Yasmin is the real thing, the guarantee of q uality, not just a copy. Anderson exposes his scheme of exchanging Yasmin samples for receipts that ensures patients effectively get two boxes for the price of one and that he obtains a sale of Yasmin instead of seeing it swapped in the pharmacy for the s imilar 13 The doctor accepts requesting a sample of the contraceptive injection Mesygyna for her empregada (domestic employee) who has just had an abortion. "I just can't do without her," she explains as she places the injection in her designer handbag. Doctors often pass on the free samples they receive to their kin or staff, a practice that pharmaceutical reps attempt to minimize to ensure each sample they deliver results in a sale. Anderson explains when we leave the consult—rio that


! ", laborator ies source data from tertiary organizations to generate a sales potential indicator for each doctor he delivers amostras to. He jokes that as the market saturates his job has become that of a sniper as he has only one shot (or sample) to hit his sales ta rget. For this reason, he is concerned about the substitutions that take place in pharmacies, undermining his painstaking work. The substitution of reference drugs with similares is also common in public health services. When women express reluctance rega rding the swapping of a pill for a different brand, doctors also employ the idiom of similarity to encourage skeptical patients to accept the proposed drug. Emphasis might be placed, as in the pharmacy, on the similitude of active principles and difference s presented as merely ones of packaging or origin. What is interesting is that substitutions between reference drugs and their copies can work in both directions, so to speak, such as when the copy becomes a popular reference in itself. This is the case wi th the contraceptive pill Ciclo21 the Brazilian copy of Schering's Microvlar It was revealed through an exchange I witnessed in a n ambulat—rio o n Salvador's periphery. The only pill available there was Microvlar a pill that was the subject of a national scandal after some 50 women declared that they had become pregnant whil e using it A woman entered the consultation room and requested the renewal of her Ciclo21 prescription The doctor took out three boxes of Microvlar mechanically completing her file. The patient protested, asking why he was changing her pill. The doctor replied that they had not received Ciclo21 "However he affirmed, Microvlar is exactly the same thing, in a different box Doubtful, the patient crossed her arms and said she did not get on well with Microvlar Irritated, the doctor reiterated: "The only thing that's different is the box, querida ( darling ) Are you going to eat the box too?" Unflustered, the woman answered that she would prefer a prescription for Ciclo21 Attempting a more conciliatory tone, the doctor began reading out the "ingredients" on the box. "It's a shame, when you can get the exact same thing here for free," he lamented. Legally, similares which are not considered interchangeable with reference drugs should not be available in the SUS. However the supply of drugs in the public sector obeys a law of bids ( Lei de Licita›es ) which favors the laboratories that offer the lowest prices, generally similares. These cases reveal some of the issues at play around the circulation of copies in the Brazilian pharmaceutical landscape. The market for copies has a complex internal dynami c, both where the difference between copy and original is concerned and between copies, which I now turn to. The substitution of brand name drugs with similares or generics has unleashed a comp lex chain of regulatory practices around the copy. In Brazil, l ike elsewhere, the proliferation in types of copies arises out of questions concerning the quality of copies As Hayden (2010 :2) has argued, "the field of the copy' [ ] is crowded." In attending to the conceptual work that similarity does as it is transfo rmed into a proper noun, Hayden opens up important questions about the differences that matter in claims to similarity. Branding, in the field of the pharmaceutical copy, consists not in carving distinctions out of a field of equivalent products (Coombe 19 98) but to the contrary in making likeness a mark of distinction (Hayden 2013 ). In the Mexican case that Hayden relates, similares are not a regulatory category but a successful brand of pharmacy that sells generic drugs In Brazil, similares form a regulatory category and refer to copies that are equivalent to a reference drug in their chemical make up ( i.e. composed of the same active principles in equivalent concentration). They are however, differentiated from generic drugs that are cons idered more equivalent and thereby "interchangeable" with a reference drug. The category "generic" aro se relatively late in Brazil and it wa s on ly in 1999, with the creation of ANVISA, that the distinction b etween similares and genericos wa s consolidated in regulatory terms. This distinction centers on the demonstration of both chemical equivalence and bioequivalence, that is, in terms of how the drug is metaboliz ed by the body.


! "" Hayden refers to this distinction as one between pharmaceutical as effect rather than as substance (Hayden 2010 :6). In practice, proving bioequivalence requires the realization of in vivo tests to measure how a copied compound acts in a living human body Given that bioequivalence is a statistical measure that allows a variation of 20% between the bioavailability of a reference drug and its copy, the gold standard of quality bio equivalence effectively "means same enough (Hayden 2010: 7 ; emphasis in the original). 14 Mauro, a consultant for a regional pharmacy chain who introduced me to several pharmacies explained that brand name drugs are promoted by representatives in doctor s practices, and similares are promoted in pharmacies but that "nobody promotes generics, they're stuck on the pharmacy shel f, not actively represented." He works with a view of democratizing access to drugs and redeveloping the role of pharmacists beyond the merely mercantile. As a public health minded pharmacist and a member of the social movement he downplays the differen ce between "researched" brand name drugs and their copies, referring to the quality of nationally produced drugs in nationalist inflected tones. Such ideas date back to the 1930s when Vargas Brazil's populist dictator and promoter of import substitution i ndustrialization declared that it was unpatriotic to use imported goods. By 1939 Brazilian pharmaceutical firms had integrated this into their marketing, drawing on the image of the "patriotic doctor" who prescribes national products that can "compete with and exceed foreign medicines" (StŸcker and Cytrynowicz 2007). Mauro sees ANVISA 's request to submit all copies to bioequivalence testing with a favorable eye, as this will reinforce the credibility of Brazilian firms. ANVISA established in 2004 that all similar drugs must present tests to establish their bioequivalence with referenc e drugs to be (re)registered with the a gency. The Brazilian pharmaceutical industry negotiated a 10 year interval to meet these requirements which ends in 2014. Given the vast portion of the market occupied by similares, a revolution seems underway. 15 Wha t will happen to similares post 2014? Will they become generics or disappear? According to the Brazilian Law of Generics, a pharmacist can only substitute a brand name drug with a generic. This raises an important question: I f similares are submitted to th e same tests as generics, will they become interchangeable with brand name drugs? This is a grey area, as technically they will be, but legally it will not be possible unless the Law of Generics is modified. The main sticking point is the question of brand To be interchangeable, similares would need to be generics and to be generics they would need to lose their brand, as generics are identified by their active principles and not by their name, unlike similares. Is this, Portilho (2012) asks, the end of t he brand for similares? It appears that ANVISA will not legislate on this issue, leaving it as a strategic decision for each business to make. The brands of which generics are stripped produce relationships between consumers and commodities (Manning 2010 ; Nakassis 2013). Their trademarks are loaded with sociocultural meaning. Without active promotion or clear channels of consumer identification, generics are somewhat forsaken, as Mauro notes. Relationships between branded products and their consumers are th e product of extensive efforts to build trust and consumer identification with products as illustrated by the case of Microvlar's demise and Ciclo21 success. The Brazilian laboratory EMS Sigma Farma's strategy is telling in this regard. In 2012 it launched a generic version of the oral contraceptive pill Yasmin containing the fourth generation hormone drospirenone. Yasmin is one of Brazil's leading brands, and is widely promoted for promoting bem estar (well being) by reducing swelling and weight gain due to the diuretic effects of the hormone drospirenone. Significantly, EMS simultaneously launched a new drospirenone containing similar marketed as Dalyne which is presented as a strategic competitor to Libbs' s Elan’ (introduced above), itse lf a copy of Yasmin Is


! "$ Dalyne pharmaceutically speaking the same as EMS' s generic copy of Yasmin but with a brand? EMS is capitalizing on the bioequivalence testing to produce both generics and a new form of copy: a branded bioequivalent copy. This indic ate s that ANVISA's call for all copies to be submitted to bioequivalence testing will not simply transform similares into generics. According to EMS (2013), Libbs currently holds half of the highly lucrative m arket for drospienone ethinyl estradiol contraceptives. EMS' s s trategy aims to capture Bayer's Yasmin clientele through legal substitutions by generics while encroaching on Libbs' s market with the promotion of the branded version of its bioequivalent Yasmin copy Dalyne (which is cheaper than its generic Yasmin ) E MS' s market strategy is reflected in Dalyne's branding which promises more : "M ore beauty, more lightness and more freedom for more women. What is striking about this case is that drospirenone is still according to Bayer under patent. In 2005 Libbs registered Elan’ with ANVISA and was sued immediately by Schering (wh ich has since been bought out by Bayer) for patent infringement. Libbs attacked on several fronts: I t claimed that Schering's drospirenone patent n umber 1101055 0 relies on technology described in patent DE 3.022.337, regis tered in 1980 and is therefore in the public domain. After two Brazilian rulings denied Libbs' s request to suspend Schering's patent, Libbs took the issue to the Brazilian Supreme Tribunal of Justice and to this day, Schering's patent has not been annulled, nor has Libbs been formally allowed or legally impeded from commercializing Elan’ I attended a series of launch events for Elan’ in Salv ador and discussed the case with Arnaldo, Libbs s regional manager H e was confident that Elan’ would go on the market as, in his words, it was more than just a copy. Unlike Yasmin Elan’ is marketed as an extended regime pill, designed to reduce the annual number of periods, and sold in packs of 28 pills. According to Arnaldo, Libbs would win against Schering as Elan’ is not just a copy, it innovates too." These pharmaceutical maneuvers reveal the extent to which the market of the copy is subject to a process of segmentation. As the monopoly of brand name drugs declines, lines of differentiation are drawn around the proliferation of emergent co pies The Brazilian pharmaceutical market is on the brink of a small revolution as similares are faded out and replaced by generics a nd a new pharmaceutical genre of branded bioequivalent copies. While EMS multiplies the sal es opportunities for its bioequivalent Yasmin copies, Libbs' s strategy is a form of imitative inn ovation that effectively rep ackages the copy. These strategies reveal the extent to which pharmaceutical marketing carefully negotiates the line between the production of something genuinely different (to protect intellectual property rights) and something completely identical or at the very least, bioequivalent. Conclusion Pharmaceutical sex hormones are peculiar objects. As chemical compounds that can be administered to prevent ovulation, suspend m enstruation, "treat" menopause certain cancers or premenstrual stress, improve skin condition, or assist in sex change s they have far reaching implications for definitions of gender, familial relations, well being and national demographics. In giving an ethnographic account of hormonal contraceptive use and prescription practices i n Brazil, this article examines how the control of variation is strategically employed by the pharmaceutical industry. This thick description of the dynamics at play in pharmaceutical development, marketing and procurement highlights the ways in which the se shape and respond to consumer choices across Brazil's two tiered health system. Given that the vast majority of hormonal drugs are procured directly in pharmacies, often without prescription, focusing solely on doctor patient interactions in public se rvices misses an important part of the picture. My aim has been to contribute to anthropological debates on pharmaceutical cultures as they relate to how drugs are made efficacious and to


! "% tensions surrounding the pharmaceutical copy ( Greene 2011; Hayden 20 07 2010 2013; Whyte et al 2002). The article considers how diversity is produced from ostensibly similar things through an analysis of the emergence of non oral modes of administration for sex hormones. Differences between contraceptive medicines are a t times strategically suspended by health practitioners in the context of emphasizing method interchangeability. I n family planning consultations where differences between pills or between pills and injectables are often bracketed together, patients may reasons resist this bracketing, as we saw with the case of the wom an who contested the prescription of Microvlar preferring Ciclo21. Conversely, differences between oral contraceptives and the sex hormones repacked in new delivery mechanisms may be highlighted, effacing the common hormonal mode of action between them This accounts for Nara 's state ment that she does not do well with hormones, although she enjoy s Mirena's menstrual suppressive effects It also accounts for how Simone can opt f or hormonal implants while explaining that she does not use medication and prefers to meditate or attend holistically to her health. Regarding the production of copied drugs the pharmaceutical industry carefully works to limit variation, striving to replicate an equivalent copy through reverse engineering. My focus here has thus been on the interplay between two types of differences: between modes of administration and between brand name drugs a nd their copies. Although these usually belong to different conversations, I examine the m together to reveal the combined effects of modulations in dosages, "original" and "copied" active principles, modes of administration and branding which together pr oduce the pharmaceutical efficacies that doctors, patients and pharmacists navigate. The specificity of steroid hormones, in relation to other pharmaceutical classes, is that users acquire them in a multitude of different galenic formulations, packaging color, or name each prescribed with slightly different indications or marketed to different patient profiles. Such variations, I have argued, have far reaching implications for the way in which the object is perceived, experienced and understood to be e fficacious. "How can pills with similar contents look so different and pills with different contents look so similar?" Greene (2011: 120) asks. "The brand of a drug does not stop at the name or logo. Rather, the brand extends into the pill itself, in the fo rm of its particular contour, bevel, engraving, or colour" ( Greene 2011:120 ). Much of the existing work on the pharmaceutical copy has attended to intellectual property issues concerning the active principles and much less to how modes of administration o r the materializations of brand that Greene outlines combine with these a gap I attempt to fill here. The way hormonal contraceptives are experienced depends on a subtle balance of tangible and int angible elements that include, beyond the chemical composit ion of a drug, its design name and, increasingly, its trademarked concept (e.g. FewerPeriods. MorePo ssibilities. for the S easonale extended regime pill). The concep t that a brand carries, such as well being or weight loss that marketing has associated with Yasmin in Brazil, seeps into the hormonal substance itself drospirenone, in this case. Thus aspects of the branding process may percolate unevenly to the copies of the chemical compounds as these are remade by generic or similar laborator ies. The generic stands at the antipode of branding processes. So much so that trademarks are at risk of a cruel form of irony if they are too successful and turn into nouns or verbs, a process known as genericide. Legal regimes strive to separate trademarks and brands from the product as when the brand and the thing merge the specificity of the brand is lost in the generic form. Pharmaceutical maneuvers around the generic must navigate a fine line, retaining something of the identity of the origin al which, as we have seen, goes beyond its pharmacological composition. The immanent reclassification o f similares in Brazil as either


! "& certified generics or branded bioequivalent copies signals that generic drugs are gaining new competitors on the side of the copy. What difference does the oxymoron "branded generic" make to the field the generic? Is this the "defeat of the generic revolution" and its promise of delivering cheap and effective drugs to all as one public health minded pharmacist I met would h ave it? Notes Acknowledgments During my visits to Salvador I was immensely lucky to benefit from the intellectual stimulation and the friendship of the researchers at MUSA, Instituto de Saœde Coletiva in particular Estela Aquino, Cecilia McCallum, Ana Paulo dos Reis and Greice Menezes. Mauro Bitencourt deserves special thanks for his guidance as do the women who shared their stories or tolerated my presence during their consultations. I am grateful t o Maurice Cassier, Alice Desclaux, Cori Hayden, Ilana Lowy, Jean Paul Gaudillire and to the three anonymous MAQ reviewers for their excellent critiques and suggestions on earlier versions of this article. 1. Although this percentage has remai ned stable, the population has expanded from 70 million in 1960 to 191 million in 2008. 2. In 2006, 20.5% of women with at least eight years of schooling relied on sterilization, compared to 65.5% of women with no formal education (PerpŽtuo & Wong 2009:93 9 4). 3. The doctors who allowed me to observe consultations usually engaged with me as well as with the medical students who were often present. 4. My interest in the question of pharmaceutical copies brought forth extensive descriptions of the market dynamics at stake, from the perspective of those promoting them. 5. This is supported by PerpŽtuo and Wong's analysis, who state: "For women without any formal education, injectable contraceptives were t he second choice, a little above female sterilization" (2009:100, my translation). 6. It found its rationale in the limited uptake of the pill worldwide a fact accounted for by reference to the heterogeneity of women's personal, cultural and religious cir cumstances. 7. Depo Provera has a troubling history, worldwide. In the U nited S tates, it was repeatedly denied FDA approval until 1992. Women s health organizations worldwide have opposed Depo Provera highlighting its potential for abuse and adverse heal th effects. 8. In his ethnography of pharmaceutical sales practices, former salesperson turned anthropologist Oldani (2004) remarks on the importance of strategic gifting in pharmaceutical marketing. This gift economy, into which pharmaceutical corporation s invest billions of dollars, serves to craft relations with doctors and gage promotional strategies as well as generate sales. 9. This fact is not unanimous. Some women, particularly those troubled by swelling and weight gain, made a clear relation between the hormonal composition of oral and non oral steroid contraceptives. 10. In Brazil most implant users obtain these through private gynecologists who source them via compounding pharmacies. Hormonal implants are presented as individually tailored to a patient's hormonal profile. For details on compounding pharmacies, see Sanabria (2010b). 11. For a detailed ethnographic analysis of the operation of pharmacies in India, where most drugs are also available over the counter, see Kamat and Nichter 199 8. 12. For an important critique of the routine use of the term "self medication" see Das and Das (2006). 13. This is an example of what Oldani (2004) refers to as a "novel [pharmaceutical] gift cycle."


! "' 14. This margin may be significant for active princi ples that have narrow therapeutic indexes, such as ARVs or hormonal contraceptives. For these drugs, minute variations that remain within the margin allowed by bioequivalence testing may have significant clinical effects (Rumel et al 2006). 15. According to the Federal Council of Pharmacy, 18,000 drug pres criptions exist in Brazil, 70% of which are similares the remaining 30% being either brand name or generic drugs. See h ttp://www.cff.org.br/sistemas/geral/revista/pdf/78/10 anvisa.pdf (accessed March 21 2013) References Cited Cassier, M ., and M Corra 2009 ƒloge de la copie: L e reverse engineering des antirŽtroviraux dans les laboratoires pharmaceutiques brŽsili ens. Sciences Sociales & Sant Ž 27:77 104. Coombe, R 1998 The Cultural Life of Intellectual Properties. Durham: Duke University Press. Corra, M 2001 Novas technologias reprodutivas : L imites da b iologia ou b iologia sem l im ites? Rio de Janeiro: Editora da UERJ CrabbŽ, P E Diczfalusy and C Djerassi 1980 Injectable Contraceptive Synthesis: An Example of International Cooperation. Science 209:992 99 4 Das, V ., and R Das 2006 Pharmaceuticals in Urban Ecologies: The Register of the Local. In Global Pharmaceuticals: Ethics, Markets, Practices A Petryna, A Lakoff, and A Kleinman eds. Pp. 171 205. Durham: Duke University Press. de Laet, M ., and A Mol 2000 The Zimbabwe Bush Pump: Mechanics of a Fluid Technology. Social Studies of Science 30:225 2 63 EMS Sigma Pharma 2013 Sigma em a ‹o. Linha Cl’nica. Prospective Report. 53 p p Greene, J 2011 The S ubstance of the B rand. The Lancet 378:120 121 Haraway, D 1991 Simians, Cyborgs, and Women: The Reinvention of Nature. London: Free Association Books. Hartmann, B 1995 Reproductive Rights and Wrongs: The Global Politics of Population Control. Revised e d. Cambridge: South End Press. Hayden, C 2007 A Generic Solution? Pharmaceuticals and the Politics of the Similar in Mexico. Current Anthropology 48:475 495 2010 New Same Things. Paper given at the History and Theory Working Group, University of Toronto, October 6 2010 2013 Distinctively Similar: A Generic Problem. UC Davis Law Review 47:601 632. IMS Institute for Healthcare Informatics 2011 The Global Use of Medicines: Outlook t hrough 2015. IMS Health Incorporated. http://www.imshealth.com/deployedfiles/ims/Global/Content/Insights/IMS%20Institute %20for%20He althcare%20Informatics/Global_Use_of_Medicines_Report.pdf (accessed June 20 2014)


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