Social Science & Medicine 73 (2011) 825e832

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Social Science & Medicine

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Get with the Program!: Pharmaceutical marketing, symptom checklists and self-diagnosis
Mary Ebeling*
Drexel University, Culture & Communication, 3141 Chestnut Street, Philadelphia, USA

a r t i c l e i n f o
Article history: Available online 26 July 2011 Keywords: USA Direct-to-consumer advertising Self-diagnosis Disease state awareness Drug marketing and branding Diagnostic tools

a b s t r a c t
During more than a decade of direct-to-consumer advertising (DTC) of pharmaceuticals in the United States, several highly controversial and contested disease states have been promoted to affect diagnostic and prescribing outcomes that are favorable to a companys branded drug. Inuencing medical diagnosis is essential to the branding of a disease, which helps to protect pharmaceutical intellectual property and assures higher prots for drug companies. Enormous marketing as well as medical resources are deployed to ensure that new diagnoses of disease states are recognized. While much work has been done investigating the marketing processes necessary to shape and dene diagnoses for many of these new disease states, such as Premenstrual Dysphoric Disorder (PMDD), the promotion of self-diagnosis within pharmaceutical marketing campaigns garner little sociological attention. This article reviews and analyzes branded disease awareness campaigns sponsored by pharmaceutical companies that employ self-diagnostic tools. By using the example of one specic disease state, PMDD, I illustrate how the marketing of self-diagnosis transforms the patient into a consumer in order to achieve the aims of a drug company. This example is contextualized within the larger theoretical framework on the sociology of diagnosis. Consideration is given to how the marketing of self-diagnosis goes beyond Jutels (2009) description of diagnosis as being the classication tool of medicine and becomes a marketing tool to construct a well-educated consumer who will demand medical diagnoses inline with a drug companys objectives. 2011 Elsevier Ltd. All rights reserved.

Introduction: the pharmaceutical marketing imperative for self-diagnosis While much research within the sociology of diagnosis eld has delineated the social processes necessary to shape and dene diagnoses for new disease states, such as those that appear in the Diagnostic and Statistical Manual of Mental Disorders (DSM) and other similar categorization instruments, less attention has focused on the powerful role of marketing strategies that encourage selfdiagnosis by patients (Aronowitz, 1998; Bowker & Star, 2000; Brown, 1995; Caplan, 2008; Conrad, 1992, 2007; Fishman, 2004; Healy, 2002; Rosenberg, 2002). Self-diagnosis as a social phenomenon mediated through medical relationships has more recently garnered interest, especially in regards to patients experience of illness and the inclusion of their bodily experience and expertise in the diagnostic process (see, for some examples: Clarke & James, 2003; Copelton & Valle, 2009; Prior, 2003; Prior, Evans, & Prout, in press; Stockl, 2007). The phenomenon of self-diagnosis that
* Tel.: 1 917 733 0008. E-mail address: mfe@drexel.edu. 0277-9536/$ e see front matter 2011 Elsevier Ltd. All rights reserved. doi:10.1016/j.socscimed.2011.05.054

increasingly exists within a cultural context where disease is commercialized and diagnosis is pharmaceutically shaped warrants further consideration of its role in pharmaceutical marketing. The marketing of self-diagnosis should also be understood within the larger context of diagnosis as a locus of struggle over power and agency (Jutel, 2009). As many social scientists of medicine have shown, diagnosis is often a highly contested social phenomenon, embedded within it relationships of power, control and contending interests (Aronowitz, 1998; Brown, 1995; Conrad, 1992; Jutel, 2009). Since the marketing appeal to patients to selfdiagnose is the basis of most direct-to-consumer (DTC) promotional campaigns, and a patients recognition of the branded afiction is vital to any successful pharmaceutical marketing campaign, it seems essential to turn our attention to the commercial promotion of self-diagnosis. Enormous marketing, as well as medical, resources are deployed to ensure that new diagnoses of diseases are recognized by the medical professionals, regulatory bodies such as the U.S. Food and Drug Administration, and patients. These disease marketing campaigns often begin years ahead of regulatory approval for

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a companys drug, and are used to sell a given disease to doctors, to the larger health industry and to the public (Fugh-Berman & Dodgson, 2008; Sismondo, 2007, 2009). Fugh-Berman and Dodgson (2008) have revealed, for instance, that within the lifecycle of a drug, promotional planning begins in the pre-clinical development of compounds in the laboratory, years before regulatory approval and legal marketing begins. Most pharmaceutical marketing efforts target doctors and health care professionals, through such strategies as detailing visits by sales representatives, promotional educational events at resorts, free samples, and targeted advertising, and account for the bulk of promotional budgets (Consumers Union, 2006; Donohue, 2006; Gagnon & Lexchin, 2008; Greene, 2007). Notwithstanding the comparatively smaller budgets, spending on direct-toconsumer marketing to patients is considerable, in the rst six months of 2009 alone DTC expenditures reached US$2.3 billion (Arnold, 2009). Since the focus of this article concerns prescription drugs marketed directly to American consumers, it is important to understand the highly consumerist context of the American medical establishment. Americans spend the largest percentage of real gross domestic product (GDP) on healthcare compared to any other country, 17.5 percent compared with the global average of 6.6 percent (Vassoler, 2010). Out of the total that American patients spend on health care costs, $792 per capita is spent on prescription drugs, well above the average $401 that patients in other OECD countries spend, and with 45 percent of total global drug sales, the United States is by far the worlds largest pharmaceutical market (OECD, 2008; VFA, 2010). The high cost of drugs in the United States is the primary factor for why Americans spend the most, American consumption rates, while behind both France and Spain, is a secondary factor contributing to spending. For drug makers, the highly marketed and medicalized cultural context in the United States is too signicant as a prot center to ignore, and thus more resources are dedicated to marketing rather than to the research and development of new compounds (Gagnon & Lexchin, 2008). Marketers have an array of tools at their disposal to promote drugs directly to consumers and these marketing practices extend well beyond the television advertisements that most Americans are familiar with. In a 2008 survey on DTC advertising in the United States, for instance, 91 percent of those surveyed said that they had seen or heard at least one drug advertisement (Kaiser Family Foundation, 2008). Consumer promotional efforts can include sponsorship of disease awareness campaigns including disease informational websites that are not obviously sponsored by a drug companyoften called unbranded websites by the marketing industrythe creation and support of patient advocacy groups, the placement of ghostwritten articles in news media, and the underwriting of large spectacles and sporting events, such as the Olympics. Following a well-established branding strategy for drugs, for instance, Johnson & Johnson subsidiary medical device maker DePuy Orthopaedics Inc. partnered with the 2008 Olympics as a corporate sponsor and aired commercials during American broadcasts of the games promoting its knee and hip replacement devices, among other promotional and branding activities. These sponsoring campaigns and other nancial support of unbranded events help to create buzz for drug makers and the disease states as well as the cures that they market. This article is a study of marketing intent: I delineate the pharmaceutical marketing strategy to induce patients to selfdiagnose in order to ensure sales revenues for drug companies. These instances reveal industry efforts to recongure patients into consumers who actively seek out diagnosis and treatments based upon their self-assessments of symptoms. A consumer, in contrast to a patient, may demand a certain drug, especially a name-brand

drug, or a specic diagnosis from her doctor, and this is precisely the type of customer pharmaceutical marketers seek to enroll. Methods My analytical focus for this article is on a marketing strategy that often draws less scholarly attention than television commercials: symptom checklists. These checklists frequently appear on branded websites for specic drugs, on unbranded websites for disease states, in doctors ofces, on pamphlets dropped off during detailing visits by sales representatives, and increasingly, as mobile phone applications, that can be downloaded and completed by patients, and presented to their doctors during ofce visits. My attention in this article centers on the development of diagnostic guidelines and symptom checklists developed for both branded and unbranded marketing campaigns for an anti-depressant and synthetic progesterone and estrogens used for birth control but marketed as a treatment for Premenstrual Dysphoric Disorder (PMDD). In order to address these issues, I rst describe the process of how a drug company helped to develop the diagnostic category of PMDD, which created a new market for its blockbuster antidepressant through the telling of the rebranding story of Prozac and Sarafem. I examine how another pharmaceutical maker marketed this newly developed diagnostic category as a self-diagnostic tool to promote its birth-control pill, YAZ, as a treatment for PMDD. The checklists analyzed here originate from the branded website for YAZ, accessible to residents of the United States, since the U.S. is one of only few countries where direct-to-consumer marketing campaigns are legal. New Zealand is the only other country that allows DTC advertising comparable to the U.S., and Bangladesh and South Korea have recently changed regulatory rules to allow limited DTC advertising within those markets. Data was collected and analyzed over an eight-month period, from October 2009 to June 2010. When one visits the drug website, the visitor must select whether or not one is in the United States, and this site makes it clear that the site is intended only for residents of the U.S. In order to analyze the checklists, I registered with the YAZ website for U.S. customers, downloaded the Body Diary checklist tool and completed the diary every day for the full 56 days as required by the checklist tool. I then coded the data collected from the checklist along with data collected from the YAZ website. In what follows, I will address patient agency, the distinctions made between patients and consumers by marketing, and how these distinctions are enrolled by symptom checklists and other self-assessment tools in order to promote branded drugs. The creation of a branded disease After more than a decade of DTC advertising and marketing of pharmaceuticals in the United States, the power that drug marketing possesses to exploit the uncertainty surrounding contested disease states and to inuence prescribing outcomes that are favorable to a companys branded drug is evident. The promotion of disease awareness is central to DTC campaigns, which are supported by years of behind-the-scenes pharmaceutical industry inuence on shaping diagnostic categories (Healy, 2006; Mintzes, 2006; Moynihan, 2005; Moynihan & Henry, 2006; Payer, 1992). The power to brand a disease early in the drug development process is essential to the branding of treatments, the patented drugs that pharmaceutical companies seek to protect from competitors, and to ensure high revenues for their brand-name pills. In order to brand a disease, pharmaceutical marketing often exerts inuence over diagnostic categories by the outright construction of new disease states, or as drug marketing thought

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leader Vince Parry advises [i]f you can dene a particular condition and its associated symptoms in the minds of physicians and patients, you can also predicate the best treatment for that condition (Parry, 2003: 43). Pharmaceutical marketing claims of patient empowerment through self-diagnosis are made within a broader context of disease marketing (Dyer, 2006). Drug marketers recognize that in order to foster a conducive marketplace for their medications, the promotion of indications and symptoms is far more protable than selling a cure; if symptoms are universal enough, virtually anyone can be rendered a patient in need of treatment (Healy, 1997). Through the creation and expansion of new disease categories, based on symptoms by those who are also developing treatments, pharmaceutical companies trade on the mutability of diagnosis (Lakoff, 2000, 2005). The determination of diagnostic categories through the branding and marketing imperatives of drug makers is not a recent phenomenon, but it has intensied with the increase in DTCA. Greene (2007) has traced the historical relationship between pharmaceutical compounds, the development of diagnostic categories as well as the construction of chronic disease states based on these categories, and the marketing of symptoms as diseases to both physicians and to patients. Through a careful delineation of three drugs developed in the later part of the twentieth century: Diuril, a diruetic; Orinase, an antidiabetic taken orally; and Mevacor, the rst statin on the American market, Greene shows how drug marketing drove expanded diagnostic screenings to apparently healthy patients, and thus in an innitely expandable universe of chronic disease the pharmaceutical industry can realize unlimited market growth (2007: 84). Pharmaceutical giant Eli Lillys top-selling anti-depressant Prozac, rebranded as Sarafem, a treatment for premenstrual dysphoric disorder (PMDD), demonstrates how drug promotion creates new diagnostic categories to expand into potential markets. The Sarafem case also serves as an exemplar of the marketing endeavor to encourage patients to become consumers: through transforming the identity of a patient who has medical needs into a consumer with culturally signicant desires to take control of ones health. The case also demonstrates quite clearly how, through the enrollment of medical authority, a drug company can brand and own a disease or a condition, thus protecting its market share and leveraging this market position to market directly to patients. Sarafem and Prozac are chemically identical. The only differences between the two drugs are branding and for which condition each is FDA-approved as treatments, either for depression or premenstrual symptoms. Under the brand-name Prozac, the chemical is used as a remedy for symptoms associated with depression, while the Sarafem-branded drug is used to treat a highly contested and little recognized condition, PMDD (Bhatia & Bhatia, 2002; Caplan, 2001; Ebeling, 2008; Greenslit, 2005; Mintzes, Morgan, & Wright, 2009; Offman & Kleinplatz, 2004). In order for a new market for an existing branded drug to be created, new indications must be identied, which often requires the recognition of novel conditions or diseases. In late 2000 Eli Lilly, faced with the prospect of looming competition from generic alternatives when the companys patent on Prozac would run out in a few months time, launched a DTC marketing campaign for Sarafem in the United States. Generic drugs are a threat to a branded drug in two ways. Firstly, they create a cheaper, chemically identical alternative to more expensive branded drugs, and it is often feared by brand-name manufacturers that most consumers would choose generics if given the choice. In his research on Sarafem, Greenslit (2005) found in the marketing literature produced by Eli Lilly to address perceived consumer safety fears of generic alternatives to Prozac, the company argued

that the generic prescription you pick up at the pharmacy wont look like brand-name Prozac. Receiving medication with a different color or shape may be unsettling or cause concern (p.480). Interestingly, this concern for consumers comfort levels in regards to the shape or color of pills did not appear to enter into the rebranding of Sarafem (although Sarafem, of course, was being promoted to treat a different condition). Secondly, and perhaps more signicantly, health insurers, including Medicaid and Medicare, will often not cover the costs of branded drugs when a generic alternative is available. It would therefore have been essential for Eli Lilly to protect its patent and produce new sources of revenue on a drug that had proven to be the companys most protable drug. One way to do this would be by foreclosing a consumers preference for generic drugs through rebranding both the drug and the disease. Eli Lilly, both through its rebranding efforts for Prozac and by enrolling sympathetic doctors and researchers who study the premenstrual symptoms some women experience, heavily inuenced the codication of PMDD as a disease state (Greenslit, 2002; Mintzes, 2006; Moynihan & Cassels, 2005). Prior to the launching of the Sarafem campaign Eli Lilly helped to get PMDD successfully recognized as a distinct disease state by the FDA in 1999. The company retained a Columbia University clinical psychiatrist who conducted clinical trials on SSRIs as a treatment for PMDD for Pzer, and who served on the DSM-IV PMDD Work Group that was tasked on developing and approving the new disease state for the 1994 edition as well as advised the group for the text revision published in 2000 (Daw, 2002; Yonkers et al., 1997). The classication of PMDD in the DSM-IV as a depressive disorder not otherwise specied opened the pathway to FDA reapproval of Eli Lillys drug to be treated for a new cluster of symptoms that were now labeled PMDD. Eli Lilly again hired the same Columbia University clinical psychiatrist to provide expert testimony to the FDAs Psychopharmacological Drugs Advisory Committee (PDAC) on both PMDD as a disease entity and on the use of uoxetine, the main ingredient in Prozac, as an effective treatment for PMDD. PDAC recommended FDA approval for the new treatment category in late 1999 (Mechcatie, 1999). By gaining FDA approval for Sarafem, Eli Lilly was not only able to extend the life of its patent but created a completely new market for its top-selling drug. For another 12 years, under the rebranded Sarafem, Eli Lillys patent on uoxetine was protected from generic copies of Prozac, because the new application for ostensibly premenstrual pathologies guaranteed the drugs continued coverage under health insurance, through the development of a previously untapped market. The approval was accompanied by Eli Lillys creation of a new diagnostic framework in the service of its drug, and the related DTC marketing campaigns that promote symptombased self-diagnosis for prospective patients. Currently the Subwork Group on PMDD and the Mood Disorders Work Group propose that PMDD be moved from the appendix to the Mood Disorders section as a category in of itself in the forthcoming DSMV, as further recognition of the once contested condition as a medically recognized disease entity (Fawcett, 2011). Patient agency in the diagnostic relationship In order to trace how symptom checklists become selfdiagnostic tools for marketing, it may be helpful to understand checklists in the social contexts, marketing as well as medical contexts, where symptoms are employed in the construction of new disease categories. Diagnoses are socially instrumentalized to perform functions beyond the simple categorization of symptoms and disease for medicine. The right diagnosis will ensure that a patients health insurer will either cover a needed treatment, or

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conversely, if perceived as too costly a disease, will not. A diagnosis can validate a patients perception of her symptoms by giving her experience a name, and equally, it can pathologize everyday, lived experiences, such as uctuations in ones mood. Diagnosis as a potent social instrument underlines the authoritative role of medicine and doctors, and as I will show, this tool is deployed by the pharmaceutical industry to inuence medical expertise in favor of its own marketing agendas (Jutel, 2009). Diagnosis, through the marketing of self-diagnosis, becomes a potent marketing tool for pharmaceutical companies. As Brown (1995) and Conrad (1992) have both demonstrated, diagnosis codies and embodies the expertise and authority of powerful groups, and positions the patient relative to doctors, to treatments, to the labels that are deployed to dene pathologies, and by extension, to dene the patient. Many examples of this social power are evident in debunked diagnoses of pathologies, such as homosexuality as a mental illness or hysteria as a distinct disease aficting women. New disease states that are highly contested and controversial, PMDD or female sexual dysfunction (FSD) being just two examples of many, tend to be stark examples that highlight the normalcy of diagnostic power. As Rosenberg (2002) has delineated, there is immense social power embedded in the ability to name a disease, the ability to give a narrative and a level of certainty to what a cluster of symptoms mean. There is often a distinction made between symptoms and diseases, and depending on who is explaining an array of symptomsda doctor, a pharmacologist working within the biomedical industry or a patientdthe process of dening disease, especially based on inexplicable symptoms, can be fraught with conicting agendas and contending interests. This is most evident in the construction of new disease states or diseases that are either not recognized or slow to be accepted by the medical establishment, as Aronowitz (1998) has shown with Lyme disease and chronic fatigue syndrome. Diagnoses are often taken up by medicalized and bureaucratized systems of control, and not to provide a patient with a name or the most efcacious treatment for the symptoms but rather to redistribute resources, control healthcare costs (by cutting out certain patients that do not t the diagnostic category) and deny health insurance coverage (Conrad, 2007; Rosenberg, 2002). At the root of the denitional struggles over diagnosis is the difculty in discerning, interpreting and translating the meaning of symptoms. Aronowitz shows that by the 20th century symptoms were largely considered subjective criteria independent of a particular disease by medical practitioners, and as advances in biomedical technologies had progressed, signsdalterations in organs and biochemistry, for instancedhad become the objective data that a doctor would use to constitute a disease (Aronowitz, 2001). Medical practice began to rely upon the biochemical data collected from a patient rather than on outward manifestations of symptoms as embodied by the patient as proof of a particular disease. Many symptoms could indicate any variety of illness, a persistent headache could indicate an endless list of diseases, but it is the biochemical information collected from bodily uids and tissue that contemporary medical practice increasingly relies on to pinpoint a disease category. These diagnostic distinctions construct disease broadly as functional and somatic diseases: functional diseases are those cases where a patient experiences symptoms but there is no physical evidence to explain the symptoms, whereas somatic disease presents physical evidence that is shown to be the cause of symptoms. Continued innovations of seemingly more precise diagnostic tools helps to legitimize both the lay and medical perception that mechanism- or anatomy-based diagnoses as progress while symptom-based diagnoses, such as chronic fatigue syndrome, are stigmatized (Aronowitz, 2001: 804). This distinction among bodily experiences can often prompt sufferers of functional

diseases to seek out diagnoses to uncover the assumed underlying physical causes of their symptoms. This is a pursuit not only after an answer or a name for a patients suffering, but more importantly, a biomedical treatment for ailments, and it is this instance of patient agency that pharmaceutical marketing seeks to enroll through its promotion of self-diagnosis. These self-diagnostic campaigns opportunistically exploit the ambiguity of what the symptoms of functional diseases mean physiologically. In the case of female sexual dysfunction, for example, symptoms as promoted by self-diagnostic checklists are codied in a physical failure rather than the result of cultural and social norms or relational pressures impinging upon a womans sexual response. If symptoms have an underlying physiological cause then a medical, and often a pharmaceutical, intervention can be applied. Through the marketing efforts to universalize symptoms through self-diagnostic checklists, disease marketing campaigns dene a new normal and narrow the diagnostic eld down to one answer: the branded drug. Many analysts recognize that diagnosis is not a unilateral phenomenon, that authority does not lie solely with those who make a diagnosis, but rather in a relational process where patients, doctors, and medical institutions negotiate the meaning of a given diagnosis. It may appear that it is the patient who originates the relationship when she seeks out a diagnosis, and hopefully treatment and relief, from the symptoms that she experiences. Yet a patients activism in advocating for her health can be threatening or subverted once she enters into the diagnostic relationship with the medical industry, especially within the context of an intensely consumerist industry that has developed in the United States, one of the two countries worldwide that allows direct-to-consumer marketing of drugs. The origins of the consumer-corporate relationship are notoriously hard to pinpoint. As Lupton (1997) and others have argued, the transformation of patients into consumers by neoliberal ideology about the free market and deregulated drug promotion means that the patient-cum-consumer becomes a rational and autonomous agent through marketing who can challenge the paternalism of the medical establishment, who can shop around for and demand to purchase medical treatment just as any other commodity and who, as a consumer, no longer has to accept the way things are, including diagnosis (see also: Applbaum, 2006; Buseld, 2010). This is the type of patientconsumer, at least, that drug marketers seek to develop through promotional work. What does it mean, though, for the patient when she self-diagnoses herself within a web of consumption (Arvidsson, 2005)? Get with the Program! the pharmaceutical promotion of self-diagnosis The marketing appeal to self-diagnose is not new; as long as mass marketing has existed patients have been encouraged to selftreat and to determine the physiological meaning of their symptoms. In the history of drug advertising, for example, patent medicines, those available without a doctors prescription, during the late 19th and early 20th centuries were advertised directly to consumers and emphasized self-treatment (Donohue, 2006). Before the FDA loosened regulations on directly marketing prescription drugs to patients in 1997, there was great public concern and debate over what implications that advertising may have for self-diagnosis. In the lead up to DTC marketing deregulation, the U.S. House Subcommittee on Oversight and Investigations requested input on DTC advertising from 37 drug companies in 1984. A majority of the industry responses were against directly marketing prescription drugs to patients (Conrad & Leiter, 2008). Conrad and Leiter note that, at the time, most of these negative responses pointed to industry fears that DTC advertising would

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unduly promote patients self-diagnosis and jeopardize the relationship of trust between a doctor and her patient (2008). Inherent in the fear was the threat that lay expertise could encroach upon medical authority. After more than ten years of DTC marketing in the United States, the industry viewpoints on both fears have reversed entirely and are considered some of the most important outcomes of marketing pharmaceuticals directly to patients. In an interview with the trade journal Medical Marketing and Media, vice-president and global business manager for Wyeth Inc.s anti-depressant Pristiq, Andreas Eggert, explained the companys goal behind the drugs new marketing campaign: The [Pristiq] ads are aimed particularly at patients who dont seek treatment or who have given up on treatment. They say, Maybe I need to accept the way it is. We want to motivate them to talk to their physician and not give up, and facilitate that dialogue (Arnold, 2009: 8). Self-diagnosis has been transformed from a threatening enactment of patient agency to a conveyance of pharmaceutical ideology in the guise of patient self-knowledge and empowerment to take action. In her examination of the relationship between the patients rights movements in the United States in the 1970s and consumer health information, Donohue (2006) shows how pharmaceutical marketers often claim that drug advertising and marketing is a tool of empowerment for the patient, rather than the industry being motivated by increasing prots. Self-diagnostic tools, such as symptom and risks checklists found on branded drug websites, are always accompanied with a doctor discussion guide that lists the points that a patient should raise with her physician, and are intended to be accompanied with the symptom checklist. Table 1 serves as an example of the potential patient autonomy inherent in self-diagnosis being limited by the marketing intention of the tool. Listed are the top 10 selling drugs and shows that each companion website for the drug offers either a symptom checklist, a risk assessment checklist or a doctor discussion checklist that all can be completed online by the patient, downloaded, printed out and taken to her next doctors appointment. For drugs that treat more severe or more complex disease diagnoses, such as bladder or lung cancer, self-diagnosis is downplayed on these websites, and doctor discussion guides that focus on the branded drug are emphasized. When printed, all of the checklists or guides are emblazoned with the companys logo and other branding associated with the specic drug. As we have seen with the rebranding of Prozac into Sarafem, womens bodily experiences can be cast as problematic symptoms in need of pharmaceutical intervention and in accordance with marketing goals. A new generation of birth-control pills have been reapproved by the FDA for treatment indications for PMDD and rebranded specically for this new market. One such birth control
Table 1 Top Ten best selling drugs and use of self-diagnostic checklists. Brand-named drug and condition for treatment Lipitor (cholesterol) Plavix (anticlotting) Advair (asthma/COPD) Remicade (arthritis) Enbrel (arthritis) Humira (arthritis & Crohnss disease) Avastin (cancer) Rituxan (cancer) Diovan (hypertension) Crestor (cholesterol) Drug maker Pzer Sano/Bristol GlaxoSmithKline Merck/J&J Pzer/Amgen Abbott Roche Roche Novartis AstraZeneca

pill, YAZ, is marketed for the treatment for symptoms associated with PMDD and severe acne. The YAZ body diary, subtitled: Get with the Program! is a checklist tool found on the branded website for the Bayer Healthcare Pharmaceuticals birth control pill YAZ and its intended use is for the self-diagnosis of PMDD. Chemically drospirenone and ethinyl estradiol, YAZ is a slightly different formulation from other birth control pills on the market. The drug has been approved by the FDA for the treatment of PMDD but has not been evaluated on its effectiveness to alleviate PMDD symptoms for more than three menstrual cycles (Division of Drug Marketing, 2008, p. 8). YAZ has been tested only for three menstrual cycles of 82 clinical trial subjects (Freeman et al., 2001). The drugs indications are, rst and foremost, for birth control, and for women seeking treatment for PMDD who use YAZ as their primary birth control choice. The branding and marketing surrounding YAZ, however, promote the drug as a treatment for PMDD. The website itself is targeted to young women and the initial experience of the home page is of the consumerist lifestyle that it promotes. There are images of fresh-faced, smiling young women, slender and fashionably dressed, engaged in various pursuits: applying makeup, playing an electric guitar, typing on a laptop. Among the safety information for YAZ, there are also tabs, labeled The Works: Fashion & Style and Front Row: Hollywood Buzz, which feature links to articles on the latest trends in fashion, tips on hair care and styling, and celebrity news. Within these sections, there is co-branded content from womens magazines, cosmetics companies and high-end fashion designers. On the YAZ website, ostensibly an informational website on a birth control pill, the health information becomes trapped in a web of aspirational consumerism, which elides the patient and the consumer into one. The checklist can be found under the YAZ Tools section and can be completed online or downloaded as a widget on a patients computer. A woman using the diary indexes her mood, emotional and physical symptoms on a daily basis for two consecutive menstrual cycles. She is to use a rating scale on which she indicates the appropriate rating choice for a given checklist item. The checklist is both vague in its description of symptoms and rigidly clear in the intent of its purpose: the checklist must lead the user to self-diagnose the DSM-IV category for PMDD. Going down the list of 11 symptoms associated with PMDD as delineated in the DSM-IV, the YAZ body diary checklist includes the same rst 11 symptoms as the DSM-IV category in precise order. Symptom 1 in the DSM-IV, for instance, denes the presence of [m]arkedly depressed mood, feelings of hopelessness, or self-deprecating thoughts, while symptom 1 in the YAZ body diary lists that the patient may have [f]elt depressed, sad, down, or blue or felt hopeless; or felt worthless or guilty. The YAZ checklists rephrasing of the DSM-IV category appears to be a recasting of psychiatrys descriptions of symptoms into vernacular terms. Within the

Estimated revenues for 2010 (US dollars, in billions) $11.7 $9.6 $9.0 $7.4 $7.1 $6.8 $6.7 $6.1 $6.0 $5.8

Self-diagnostic, risks, or doctor discussion guide checklist Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

List adapted from FACTBOX-Worlds top-selling drugs in 2014 vs 2010, Reuters, April 13, 2010.

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checklist there is no room for ambiguity in regards to the chosen rating, it is not possible to register a 1.7 or a 4.3, nor is there any space where a woman can record her mood in her own words. For example, Item 3 on the checklist asks the user to rate on a scale from 0-5dzero being not at all, 5 being extremedwhether she experienced mood swings on a given day, whether she suddenly felt tearful or sad, or her feelings were easily hurt. Mood swings where a woman feels, say, joyfulness, hopefulness, blissfulness or exuberance cannot be registered. Yet Item 9 on the checklist exemplies ambiguity, which tasks the user to categorize on the rating scale whether she slept more, took naps, found it hard to get up when intended; or had trouble getting to sleep or staying asleep. Both the length of the diary and the symptom checklist fall inline with the diagnostic category for PMDD as listed in the DSMIV (see Tables 2 and 3 for a comparison). Aside from the FDAs Division of Drug Marketing, Advertising and Communications (DDMAC) regulating all direct-to-consumer marketing communications, it is not a coincidence that the YAZ checklist follows an almost verbatim, line-by-line reiteration of the DSM-IV entry for PMDD. The checklist was co-authored by the same clinical psychiatrist retained by Eli Lilly in the case of Sarafem, and who helped to author the relevant DSM-IV category. As the YAZ diary serves as a pathologizing checklist for womens emotional and bodily experience of menstruation through its construction of the experience to t the PMDD diagnostic category, it is also a standardization instrument to categorize what is biologically normal and what is not. The checklist can only record a 28day cycle, considered an average for womens menstrual cycles, since most women never experience a 28-day cycle each and every month, even if a woman has no other complicating factors such as endometriosis or polycystic ovarian syndrome. If a woman experiences a menstrual cycle outside the standardized 28 days, say 31 days one month and 27 days the next, this information cannot be captured by the checklist. At the end of 56 days, or two consecutive 28-day menstrual cycles, no more entries can be made into the diary and a printable report is generated. In order for a doctor to make a diagnosis of PMDD, 11 of the 13 symptom categories must be present for two consecutive menstrual cycles. As it has been designed, the YAZ diary functions as a technology of self-regulation that disciplines the patients bodily experiences into a marketing diagnostic framework (Foucault, 1988). The YAZ body diary is
Table 2 PMDD diagnostic criteria. Premenstrual Dsyphoric Disorder (DSM-IV categorization)

useless as a self-diagnostic indexing tool in of itself, as it must be accompanied with the printable physicians report that a patient can hand over to her doctor. It is the doctor who interprets the patients self-collected data to make the nal diagnosis of PMDD and prescribe a pharmaceutical treatment. Since the physicians report is emblazoned with the YAZ brand, it is ultimately a marketing appeal to the doctor to make the obvious, branded choice. The self-diagnostic tool, whilst portrayed as being a tool for patient empowerment, is also an indexing instrument for pharmaceutical marketing to determine the eld of diagnostic possibilities. While my analysis of symptom checklists concludes that the intent of such tools is to shift the initiation of diagnostic determination to the patient and to determine the scripting choices of doctors, how effective are these marketing self-diagnostic tools and doctor discussion guides in generating sales of brand-named drugs? While the marketing industry seeks out evidence of a causal relationship between a marketing campaign and increase revenue for a client, the hard data that would prove that are much more elusive to pin down and are often contradictory. Mintzes et al. (2003) found when they surveyed patients and their doctors in the U.S. and Canada, that patients exposed to a trifecta of DTC advertisements for branded drugs, patient educational campaigns on branded diseases or conditions, and the use of pharmaceutical marketing as an information source were twice as likely to request a brand-name drug from their doctors than patients who were not exposed to DTC advertising. A recent marketing study that examined more than 12,000 patient-doctor interactions, however, found that far from marketings attempt to inuence the conversation, in only 3 percent of conversations did a patient mention a drug advertisement or marketing information by name, and in only .002 percent of patient conversations was a request made for a brandname drug (Verilogue Inc., 2009). In the instances where branded drugs or DTC marketing campaigns were mentioned by patients, it was often to discuss with a doctor the negative side effects raised in advertising, or the relative expense of a brand-name drug and generic alternative. This one study indicates perhaps that patients are highly sophisticated consumers of marketing information, and are quite cynical about it. Far from the intended purpose of checklists to shape the patient-doctor conversation positively for pharmaceutical makers, perhaps the outcome should be

A. In most menstrual cycles during the past year, ve (or more) of the following symptoms were present for most of the time during the last week of the luteal phase, began to remit within a few days after the onset of the follicular phase, and were absent in the week postmenses, with at least one of the symptoms being either (1), (2), (3), or (4): 1. Markedly depressed mood, feelings of hopelessness, or self-deprecating thoughts 2. Marked anxiety, tension, feelings of being keyed up or on edge 3. Marked affective lability (e.g., feeling suddenly sad or tearful or increased sensitivity to rejection) 4. Persistent and marked anger or irritability or increased interpersonal conicts 5. Decreased interest in usual activities (e.g., work, school, friends, hobbies) 6. Subjective sense of difculty in concentrating 7. Lethargy, easy fatigability, or marked lack of energy 8. Marked change in appetite, overeating, or specic food cravings 9. Hypersomnia or insomnia 10. A subjective sense of being overwhelmed or out of control 11. Other physical symptoms, such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of bloating, or weight gain B. The disturbance markedly interferes with work or school or with usual social activities and relationships with others (e.g., avoidance of social activities, decreased productivity and efciency at work or school). C. The disturbance is not merely an exacerbation of the symptoms of another disorder, such as major depressive disorder, panic disorder, dysthymic disorder, or a personality disorder (although it may be superimposed on any of these disorders). D. Criteria A, B, and C must be conrmed by prospective daily ratings during at least two consecutive symptomatic cycles. (The diagnosis may be made provisionally prior to this conrmation.) Adapted from the American Psychiatric Association (1994). Diagnostic and statistical manual of mental disorders. 4th ed. Washington, D.C.: American Psychiatric Association, 717-8, and Bhatia, S. C., & Bhatia, S. K. (2002). Diagnosis and Treatment of Premenstrual Dysphoric. Disorder. American Family Physician, 66(7), 1239-1249.

M. Ebeling / Social Science & Medicine 73 (2011) 825e832 Table 3 YAZ body diary rating scale. Daily record of severity of problems Your rating on a scale from 0 to 5:(0: NOT AT ALL 1: MINIMAL 2: MILD 3: MODERATE 4: SEVERE 5: EXTREME) 1.Felt depressed, sad, down, or blue or felt hopeless; or felt worthless or guilty 2.Felt anxious, tense, keyed up or on edge 3.Had mood swings (i.e., suddenly feeling sad or tearful) or was sensitive to rejection or feelings were easily hurt 4.Felt angry, or irritable 5.Had less interest in usual activities (work, school, friends, hobbies) 6.Had difculty concentrating 7.Felt lethargic, tired, or fatigued; or had lack of energy 8.Had increased appetite or overate; or had cravings for specic foods 9.Slept more, took naps, found it hard to get up when intended; or had trouble getting to sleep or staying asleep 10.Felt overwhelmed or unable to cope; or felt out of control 11.Had breast tenderness, breast swelling, bloated sensation, weight gain, headache, or joint or muscle pain, or other physical symptoms 12.At work, school, home or in daily routine, at least one of the problems noted above caused reduction of productivity or inefciency 13.At least one of the problems noted above caused avoidance or less participation in hobbies or social activities Adapted from the physicians report for the YAZ Body Diary. Copyright Jean Endicott, PhD and Wilma Harrison, MD.

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understood in more general terms, that the checklists help the patient recognize the branded disease in her symptoms and to get the conversation going with her doctor. Conclusion Symptom checklists developed collaboratively by drug marketers and medical practitioners have become the mainstay of virtually every branded and unbranded marketing campaign for pharmaceuticals. Checklists are efcient tools that, in tandem, universalize and personalize the bodily experience of symptoms and translate that experience into a need for treatment and action by the patient. Much like diary-keeping espoused by the authors of self-help books as a corrective intervention on the past, symptom checklists are deployed by marketing to be a proactive intervention on the present (Giddens, 1991: 72). The power of diagnosis lies within the social power to name a disease, to dene and frame symptoms as pathologically indicative of a disease state, to codify what is normal and what is deviant, and to provide social order to chaotic bodies (Foucault, 1984; Jutel, 2009; Rosenberg, 2002). Diagnosis in every case is, of course, a cultural phenomenon, a system of identication and categorization, embedded within it cultural beliefs and meanings about the self and others, identity, normalcy and deviance, health and inrmity. Through the pharmaceutical promotion of the instruments of self-diagnosis, diagnostic power is removed from the exclusive purview of medical authority and placed by marketing into the hands of patients. Self-diagnosis has the potential to redistribute power within medically mediated relationships, such as the relationship of power and trust between a patient and her doctor. Yet in this subversion of power, the pharmaceutical marketing ideologies are distributed seamlessly while appearing to put decisions and determinations about health and optimized action into consumers hands. If the health consumer does not take responsibility for her own health, and participate in these promotional efforts to selfdiagnose, she has failed to be a good consumer. It is a rhetorical sleight of hand reminiscent of what Wacquant (2009) might say is the neoliberalization of the less powerful through the individualization of responsibility. Direct-to-consumer marketing of selfdiagnosis offers particularly clear evidence of drugmakers intentions and receptions: symptom checklists position patients as active participants in the construction of the branded drugs and in the branding of highly contested disease states. The aim is for patients to recognize the disease for the symptoms and to become brand advocates for drugs that are marketed to treat those disease states. Symptom checklists are tools of consumer recruitment for marketing, where consumers perform self-diagnosis that is harmonized with the symptoms that the sponsored drug is

approved to treat, and through this self-diagnosis, are empowered to demand a diagnosis that will call for a treatment option that points to a branded drug from their doctors. The checklists are also a marketing subversion of patient agencydmarketing enrolls a patients agency in relation to her health to direct her to the right diagnosis: the diagnosis that will be treated by a branded drug. Acknowledgments I would like to thank the editors of this special issue, Annemarie Jutel and Sarah Nettleton, for all of their efforts in the organization of this publication. I would also like to give my gratitude to the readers of the various early drafts of this article for their guidance, input and, above all patience, these include Cati Coe, Kathryn Howard, Timothy Portlock, Inmaculada Garcia-Sanchez and Amy Slaton. Finally, I would like to thank the anonymous reviewers of my article for their insights and suggested changes. References
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