Somatic Symptom Disorders

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Social Science & Medicine 73 (2011) 833e842

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Listening to Lyrica: contested illnesses and pharmaceutical determinism

Kristin K. Barker*

Oregon State University, Sociology, Fairbanks Hall, Corvallis, OR 97331, United States

a r t i c l e i n f o

Article history: Available online 28 July 2011

Keywords: Contested illnesses Fibromyalgia Direct-to-consumer-advertising Medicalization USA Medications Gender

* Tel.: þ1 541 737 5375. E-mail address: [email protected].

0277-9536/$ e see front matter � 2011 Elsevier Ltd. doi:10.1016/j.socscimed.2011.05.055

a b s t r a c t

Fibromyalgia syndrome is a debilitating pain disorder of unknown origins and a paradigmatic contested illness. As with other contested illnesses, the reality of fibromyalgia is disputed by many physicians. Thus, millions of individuals who are diagnosed with fibromyalgia must cope with chronic symptoms as well as medical and public skepticism. In this context, the U.S. Federal Drug Administration’s approval of Lyrica, the first prescription medication specifically for the management of fibromyalgia, is of consid- erable interest. In this paper I examine the cultural logic whereby the existence (and marketing) of an officially approved prescription medication for a condition lends support to the biomedical existence of the condition itself. I label this logic pharmaceutical determinism and argue that it represents an important new phase in the proliferation of contested illness diagnoses. Using the case of Lyrica, I describe the role that pharmaceutical companies and pharmaceuticals themselves play in promoting and legitimating contested diagnoses and validating those who are so diagnosed. Through a narrative analysis of the Lyrica direct-to-consumer advertising campaign and the responses of fibromyalgia sufferers to the introduction and marketing of Lyrica, I demonstrate the symbiotic relationship between the interests of the pharmaceutical industry, contested illness legitimization, and medicalization. I also provide a gender analysis of this relationship, foregrounding how contested illnesses continue to be shaped by their feminization in a cultural context that equates women with irrationality. Finally, I address the consequences and limitations of relying on the pharmaceutical industry for illness validation.

� 2011 Elsevier Ltd. All rights reserved.

Fibromyalgia syndrome is a pain disorder of unknown origins. In addition to chronic widespread pain, fibromyalgia is often charac- terized by a host of associated symptoms, the most common of which are fatigue, sleep irregularities, and cognitive and mood disorders. The condition is said to affect between 2 and 5 percent of the U.S. population, with a female to male ratio of approximately 9:1 (Neumann & Buskila, 2003). Fibromyalgia is not attributable to any known organic abnormality (Wolfe, 2009). It is not detectable using blood tests, x-rays, or other diagnostic tools. Instead, after ruling out other possible causes for a patient’s symptoms, fibro- myalgia is diagnosed using criteria established by the American College of Rheumatology (ACR) in 1990. The formal criteria include the patient’s report of widespread pain for at least 3 months and tenderness in at least 11 of 18 locations on the body, called tender points, to which pressure is applied during a physical examination (Wolfe et al., 1990).

Parenthetically, tender points do not correspond to any anatomical structure nor does tenderness in these locations correspond to any observable pathology (Milton,1999). It also bears

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noting that in clinical practice the tender point criterion is not strictly observed. It has been suggested that patients who report fewer than 11 tender points be diagnosed if they also report a number of symptoms commonly associated with fibromyalgia (e.g., fatigue, sleep and mood disorders, bowel irregularities) even though the presence of these symptoms are not included in the formal diagnostic criteria (Csillag, 1992). In response to acknowl- edged irregularities associated with diagnosing fibromyalgia, new ACR guidelines were recently proposed, which are intended to compliment, not replace, the 1990 criteria (Wolfe et al., 2010). The new guidelines emphasize symptom severity and pain level rather than tender points.

Because fibromyalgia is determined by exclusion and inexactly, many physicians remain skeptical of the diagnosis and the patients so diagnosed. Not only are there concerns about the vagueness of the diagnosis, but there is also the nagging question about whether fibromyalgia is “real” (i.e., has organic biological origins) or not (i.e., is psychogenic). The feminization of the disorder intersects with cultural stereotypes about women’s emotionality and irrationality, leading some critics to claim that fibromyalgia is a form of modern day hysteria (Hadler, 1997; Showalter, 1997). Consequently, for millions of women, living with fibromyalgia requires managing

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a constellation of chronic symptoms while coping with medical and public skepticism. It frequently takes a protracted time and considerable tenacity to find a health care provider who believes in fibromyalgia and is willing to diagnose and treat fibromyalgia patients. Such providers are referred to as “fibro-friendly.” Although being diagnosed generally affords sufferers considerable peace of mind and some degree of validation (i.e., they are not dying; there is a name for their condition; it’s not all in their head), it rarely brings the experience of medical disparagement to an end (Barker, 2005).

In all these regards, fibromyalgia is a paradigmatic contested illness. In the last two decades there has been a dramatic rise in the number of contested illness diagnoses and contested illness sufferers (Barsky & Borus, 1999). Approximately ten million Americans, most of them women, are diagnosed with one of several syndromes characterized by a cluster of common and troubling symptoms (e.g., pain, fatigue, mood irregularities) that are not attributable to any organic abnormality (Manu, 2004; Wessley, Nimnuan, & Sharpe, 1999). In addition to fibromyalgia, some of these conditions include chronic fatigue syndrome, tension head- ache, temporomandibular joint disorder, irritable bowel syndrome, and multiple chemical sensitivity disorder. On the one hand, there is a lack of conventional biomedical evidence for the existence of these conditions. On the other hand, sufferers report significant reductions in functional abilities, health status, and quality of life, with little sustained improvement in well-being over time (Manu, 2004; Wessley et al., 1999). In fact, these conditions are called “contested illnesses” precisely because they represent a clash between biomedical knowledge and patient experience (Conrad & Stults, 2008; Moss & Teghtsoonian, 2008). Contested illness sufferers, including those with fibromyalgia, must therefore engage in an ongoing struggle to have medically unexplainable symptoms recognized in orthodox biomedical terms despite resistance from medical professionals and institutions.

In the case of fibromyalgia, the ongoing debate about whether the condition is a “real” biomedical entity entered a new phase in June 2007, when the Food and Drug Administration (FDA) approved the first drug specifically for its management. Patient advocates and a small handful of clinician-researchers with whom they are allied, heralded the approval of Pfizer’s Lyrica for fibromyalgia as a thera- peutic and symbolic victory. Two additional drugs have subse- quently received FDA approval for fibromyalgia. Beyond the potential therapeutic benefits, sufferers hope that the FDA approval of drugs specifically for the management of fibromyalgia will finally validate fibromyalgia in the eyes of the public and medical skeptics. Their hopes are not without foundation. A number of scholars duly note that the pharmaceutical industry (also known as Pharma) now possesses significant cultural authority when it comes to defining and legitimating diagnoses and disease entities (Conrad & Leiter, 2008; Greene, 2007; Loe, 2004; Williams, Gabe, & Davis, 2008). It is increasingly the case that the mere existence of a prescription medication for a condition is used to authenticate the biomedical existence and character of the condition itself. I label this phenomenon pharmaceutical determinism and suggest that it represents an important new phase in the proliferation of con- tested illness diagnoses.

Using the case of Lyrica, I describe the role pharmaceutical companies and pharmaceuticals themselves play in promoting and legitimating contested diagnoses. That is, I illustrate how the logic of pharmaceutical determinism plays out in the case of fibro- myalgia and suggest its applicability to other contested illnesses. Through a narrative analysis of the Lyrica direct-to-consumer advertising (DTCA) campaign and the responses of fibromyalgia sufferers to the introduction and marketing of Lyrica, I demonstrate the symbiotic relationship between the interests of the

pharmaceutical industry, contested illness legitimization, and medicalization. In addition, I provide a gender analysis of this relationship wherein I underscore how contested illnesses continue to be shaped by their feminization and a cultural milieu that equates women with irrationality. Finally, I address the limitations of relying on the pharmaceutical industry for illness validation.

Medicalization: fibro and pharma

Medicalization is the process by which ever more aspects of the human condition are defined and treated as medical in character. Although there have been a few notable instances of demedicali- zation (e.g., homosexuality and masturbation), medicalization has been a dominant trend. Many different types of human experiences and problems have been medicalized, including deviant behavior, natural life processes, and everyday problems of living (Davis, 2009). Although the trend toward medicalization is long- standing, the principal forces behind the process have changed. Campaigns on the part of physicians to expand their jurisdictional authority were a primary “engine” of medicalization during the first three quarters of the twentieth century (Conrad, 2005). Par- alleling a decrease in professional power more generally, however, physicians’ role in medicalization has declined in relative impor- tance while that of patient consumers and powerful corporate entities have increased. For example, it is increasingly patients rather than physicians who are eager to classify their “physical distress” and “uncomfortable body states.as diseases” (Barsky & Borus, 1995: 1913). Fibromyalgia and other contested illnesses fit this description.

The pharmaceutical industry, one of the most profitable sectors in the global economy, has also become one of the most influential players in contemporary medicalization. The means by which pharmaceuticals contribute to medicalization, or “pharmaceutic- alisation” (Fox & Ward, 2008; Williams, Seale, Boden et al., 2008), are complex and multi-dimensional, but one particularly effective route is through direct-to-consumer advertising (DTCA) (Moynihan, Heath, & Henry, 2002). Only two countries, the United States and New Zealand, currently permit DTCA. In the United States, televised DTCA took off in the wake of deregulations associated with the passage the FDA Modernization Act (FDMA) of 1997. According to an oft-quoted (and likely conservative) esti- mate, the pharmaceutical industry spent $4.2 billion on adver- tising directly to American patient consumers in 2004 d twice what it spent on research and development (Donohue, Cevasco, & Rosenthal, 2007).

Using sophisticated marketing techniques, televised DTCA campaigns encourage individuals to “ask their doctors” if a partic- ular medication is a solution to their problems (Frosch, Krueger, Hornik, Cronholm, & Barg, 2007). While there is the potential that DTCA can educate some consumers about beneficial medica- tions, many of the problems DTCA target are trivial (Conrad, 2007; Moynihan & Cassels, 2005). Others are exceedingly common and not life threatening (Mintzes, 2002). It would seem that all prob- lems, however small, common, or benign, can be marketed as a medical problem that can be mitigated with medication. The Viagra DTCA campaign is legendary and its relationship to medi- calizing healthy men’s sexual performance is widely recognized (Loe, 2004). The moderate inconvenience of frequent calls of nature associated with normal aging has morphed into overactive bladder for women and benign prostatic hyperplasia for men. Add to this list the DTCA campaigns for Paxil and Sarafem, which promoted the new diagnoses of social anxiety disorder and premenstrual dysphoric disorder respectively (Conrad & Leiter, 2008; Tiefer, 2006). The condition “Low T” (low testosterone), characterized by declining energy and “fun” in men over 45, is a recent illustration of

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how DTCA reframes common experiences as symptoms of specific disorders in an effort to increase consumer demand for products and, ultimately, corporate profits.

As these examples suggest, some DTCA campaigns focus on selling the diagnosis as aggressively as the medication designed to treat it. In some cases the campaign is selling a medication for which the diagnosis has been designed. This situation has led some critics to accuse the pharmaceutical industry of engaging in outright disease mongering (Angell, 2004; Payer, 1992). Whether these campaigns are educating and empowering consumers (Bonaccorso & Sturchio, 2002) or selling sickness (Moynihan & Cassels, 2005), the result is a dramatic increase in the market for these prescription drugs. The evidence is clear: DTCA campaigns increase prescription requests on the part of patients that result in physicians prescribing requested medications, even when they do not believe the drugs are clinically warranted (Mintzes et al., 2002). But, when DTCA encourages consumers to self-diagnose as a precursor to a prescription request, physicians may also comply with the patient’s requests for a diagnosis about which they are skeptical. In short, the pharmaceutical industry is increasingly an active party in the diagnostic process. The pharmaceutical industry, as noted by Jutel (2009: 291), is now an important “engine of diagnosis.”

DTCA encourages the belief that there is “a pill for every ill” and, increasingly, “an ill for every pill” (Mintzes, 2002). The latter sentiment is an outcome of the pharmaceutical industry’s growing cultural authority to define the object of medicine; that is, to define disease. In Listening to Prozac (1993) Peter Kramer reflects on “cosmetic pharmacology” (i.e., using anti-depressant medications to feel “better than well”). Kramer’s book also draws attention to the larger cultural tendency to emphasize pharmaceutical solutions for various painful aspects of the human condition, as well as the corresponding power we have bestowed upon prescription medi- cations to define what is biomedically real. Similarly, Jeremy Greene (2007: 227) chronicles how clinical trials for pharmaceuticals play an increasingly influential role “in propping up the ‘diseaseness’ of a putative pathological category.” The logic is as follows: if there is a prescription medication to treat a problem, then the problem must be a biomedical disease. Furthermore, as explained by Andrew Lakoff (2006), the specific pharmacological approach points to what type of thing the “disease” is. For example, if a condition responds to a drug that impacts the central nervous system, then the condition is a central nervous system disorder. As previously noted, I refer to this logic as pharmaceutical determinism and it is of considerable salience with respect to fibromyalgia.

Elsewhere I provide a detailed description of how the coming together of women with a host of distressing symptoms and a small group of rheumatologists (whom I refer to as “diagnostic entre- preneurs”) led to the diagnostic making of fibromyalgia syndrome (Barker, 2005). The result was the ACR diagnostic criteria for fibromyalgia adopted in 1990. Fibromyalgia is a diagnostic label given to medically unexplained symptoms that are widespread in the general public and particularly common among women. Compared to men, women report more chronic ailments, pain, and dysfunction; they experience more physical discomfort and corre- sponding limitations; they have higher rates of depression; they use more prescription and over-the-counter medications; and, they have higher rates of health care utilization (Bird & Rieker, 2008). These patterns represent the complex interplay of biological, social, and political realities (Doyal,1995; Lorber,1997). What is important for our purposes is to recognize that, in recent decades, women’s high rates of morbidity have increasingly become organized into contested illness diagnoses like fibromyalgia. That is, contested illnesses can be viewed as social constructions that transform women’s common symptoms into medical diseases.

At the level of experience, the fibromyalgia diagnosis provides sufferers with a framework for giving meaning to their distress. Among other things it gives women a name to tie together a dizzying array of otherwise disparate symptoms. However, insofar as fibromyalgia remains medically contested, the medical- ization of women’s distress under the rubric of the fibromyalgia remains incomplete. Herein lies the importance of pharmaceutical determinism to the story at hand.

Since the establishment of the ACR criteria, the treatment protocol for fibromyalgia has been a symptomatic approach. Patients are frequently given a prescription medication for each of their numerous symptoms (e.g., pain, sleep irregularities, mood disorders, bowel distress, etc.), and treatment outcomes are generally poor (Goldenberg, Burckhardt, & Crofford, 2004). Lyrica is approved as a systemic drug therapy for fibromyalgia. In clinical trials it was found to improve functioning among those diagnosed with fibromyalgia (Arnold et al., 2008; Crofford et al., 2008). In other words, the drug’s approval gives creditability to the notion that fibromyalgia is a discrete biological thing, rather than a collection of disparate symptoms that are poorly managed with a hodgepodge of existing medications. It is further suggested that Lyrica confirms what type of biological thing fibromyalgia is. Lyrica is an anticonvulsant medication, said to benefit fibromyalgia patients by binding to neurotransmitters in the brain and spinal cord, effectively reducing activity in the central nervous system (Crofford et al., 2005). Fibro-friendly clinician-researchers, including those working with and for Pfizer, maintain that Lyrica corroborates the theory that fibromyalgia is a neurochemical aberration wherein neurons become hyperresponsive to stimuli, a state referred to as “central sensitization” (Crofford et al., 2005). Since the approval of Lyrica, two anti-depressant medications (Cymbalta and Savella) have also received FDA approval for fibro- myalgia. Like Lyrica these medications are approved for the systemic management of fibromyalgia. Although they are anti- depressants, these drugs are said to improve functioning in fibro- myalgia patients, independent of depression, via mechanisms that shore up the theory of central sensitization (Recla, 2010).

The FDA approval of Lyrica for the management of fibromyalgia and subsequent DTCA campaign must be understood in the context of the disorder’s contested status, its feminization, and the cultural authority conferred upon pharmaceuticals to define biomedical reality. To that end, what follows is a close examination of the DTCA campaign for Lyrica and the response of fibromyalgia sufferers to the drug’s introduction and marketing.

Data and methods

The data I use in this analysis come from multiple sources. First, I examine the central feature of the DTCA campaign for Lyrica. This includes the six television commercials aired during network news programming in the United States from the time the first commercial appeared in November 2007, through May 2010 when this article was written. I also include an informal feature of the DTCA campaign, a television public service announcement created jointly by Pfizer and a leading fibromyalgia advocacy group. I accessed the commercials through the Vanderbilt Television News Archive (http://tvnews.vanderbilt.edu/). To analyze the commer- cials I used the schema developed by Frosch, Krueger, Hornik, Cronholm, and Barg (2007) as a template. As specified in this template, the basic story line of DTCA includes three elements: loss of control due to illness/condition; regaining control through use of medication; and concomitant social rewards. These elements represent a plot, or a series of incidents that are sequentially organized, and a plot is the hallmark of a narrative (Riessman, 2008). Accordingly, I analyze these commercials as narratives.

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Beyond identifying the basic story being told, narrative analysis focuses on why a particular narrative is constructed (i.e., what is the purpose of the narrative), emphasizing who is telling the story and who is thought to be listening (Riessman, 2008; Spencer, Ritchie, & O’Connor, 2003). The commercials were analyzed using NVivo, a computer-assisted qualitative data analysis software program. The analysis focused on how the commercials’ narrative elements are presented in relationship to the promotion and legitimization of the fibromyalgia diagnosis. As part of this undertaking I paid particular attention to content that directly or indirectly addressed the conflation of women’s cultural legitimacy and the legitimacy of the fibromyalgia illness experience.

The main data used to capture the response of fibromyalgia sufferers to Lyrica are electronic postings to a bulletin board run for and by fibromyalgia sufferers, which is given the pseudonym Fibro Spot. As part of an earlier research undertaking, I collected all the postings to Fibro Spot from February 1, 2004 through February 28, 2005 and February 1, 2007 through February 28, 2008 (Barker, 2008). In early 2007, Fibro Spot’s homepage was one of the top five online support groups listed in a Google search for “fibro- myalgia.” The analysis I present here takes advantage of this previously collected data, but I use only those posts that specifically address Lyrica (pregabalin). The electronic posts were analyzed using NVivo with an eye toward content that addressed the rela- tionship between Lyrica and the legitimization of the fibromyalgia diagnosis and illness experience. The study received a human subjects exemption from Oregon State University Institutional Review Board.

To supplement these data, and specifically to track the response to the Lyrica DTCA campaign after 2008, I conducted a Google search for “Lyrica commercial” on June 1, 2010. This search gener- ated nearly a half a million hits. I evaluated the most visible comments about the DTCA campaign (i.e., the highest ranked in this Google search) contributed by fibromyalgia sufferers to a variety of public forums, such as blogs and online newsgroups. This latter technique is not intended to be comprehensive. Rather I have used these comments to provide a snapshot of the most visible responses to the Lyrica DTCA campaign as expressed online.

Analysis

Pharmaceutical Opportunism: DTCA & making fibromyalgia real

Fibromyalgia is only the most recent indication for which Lyrica had been approved. The drug received FDA approval in 2004 for the treatment of neuropathic pain associated with shingles and dia- betes, and as a supplementary treatment for partial onset seizures in patients with epilepsy in 2005. Pfizer introduced Lyrica as a “follow-on” medication to its highly lucrative predecessor Neu- rontin (gabapentin). That is, the drugs are very similar to one another, but Neurontin was on the eve of losing patent protection. In fact, Pfizer was found guilty of fraudulent marketing practices and paid a criminal fine of $50 million for encouraging physicians to switch patients from Neuorontin to Lyrica on an off-label basis, which is the practice of prescribing a drug for a condition for which it has not been approved (O’Reilly & Capaccio, 2009). In the meantime, with Lyrica already approved for the management of other pain states, Pfizer sought and received an expedited approval for the management of fibromyalgia. The vast market potential for fibromyalgia drugs is well recognized. According to a report by Decision Resources, a leading research and advisory firm to the pharmaceutical industry, the use of Lyrica, Cymbalta and Savella will result in an eight percent annual growth in the fibromyalgia market over the next eight years in the United States, Europe and Japan (Hohenberg, Wilson, Daley, & Fam, 2007). As explained in the

report, “The arrival of drugs with regulatory labeling for fibro- myalgia and the attendant marketing and increased awareness of fibromyalgia will quadruple the size of this relatively new drug market.” The report then asks: “How might drug developers capi- talize on fibromyalgia patients’ need for drug therapy?” (http:// decisionresources.com/Products-and-Services/Report? r¼pcorpn0108).

Increasing public awareness of fibromyalgia and declaring its status as “real” have been major prongs in Pfizer’s plan to capitalize on the fibromyalgia market. In August 2007 Pfizer joined forces with the largest fibromyalgia advocacy organization in the United States, the National Fibromyalgia Association (NFA), to create a fibromyalgia awareness campaign. The Pfizer-NFA campaign included a televised public service announcement and an interac- tive website. The public service announcement featured a montage of people, most of them in tears, explaining their intense pain, after which the following voiceover is heard:

� Imagine feeling this kind of pain and no one knows what it is or believes you even have it. This is fibromyalgia. Very real chronic widespread pain and tenderness that affects millions. There is hope. There is help. If you’re suffering talk to your doctor and visit Fibrohope.org for more real stories (National Fibromyalgia Association, 2007).

In addition to real stories about fibromyalgia, Fibrohope.org provided visitors with the phone number to Pfizer’s call center where they could receive “information about a prescription treat- ment option.” In short, Pfizer’s sponsorship of the website and the company’s alliance with NFA is paradigmatic of what others have argued is in fact pharmaceutical marketing through apparent awareness education initiatives (Angell, 2004: 135; Moynihan and Cassels: 132) The FibroHope website is no longer active but it was online from June 2007 to July 2008 and is accessible on the Internet Archive (see http://web.archive.org/web/20080623213233/http:// www.fibrohope.org/).

The first television advertisement for Lyrica aired a few months later in November 2007. The commercial opens with an exceedingly thin middle-aged woman reading from her diary. She appears to be very much in distress, her face clenched as she reads the following diary entry: “Today I really struggled with my fibromyalgia. I had pain all over. My muscles ached, so tender to the touch.” She sets down her diary, sighs, looks directly at the camera, and proclaims: “Fibromyalgia is a real, widespread pain conditionwhich also makes daily activities difficult.” She continues: “But until recently there were no medicines approved by the FDA to manage fibromyalgia. Prescription Lyrica is the first and only FDA approved treatment that can help relieve fibromyalgia pain and improve function.” The commercial ends with the visibly less distressed woman encour- aging viewers to “ask their doctor” about Lyrica.

This advertisement ran for five months until it was replaced by two new commercials that aired during 2008. The first of these opens with a dark haired middle-aged woman sitting in her shadowy kitchen telling the audience that fibromyalgia pain made it hard to just do the little things she loved. “But then my doctor told me about Lyrica.” Next we see the woman happily tending her beautiful garden as she explains, “Lyrica helps me accomplish my daily activities and helps me feel better. So now I can start to think of something other than my pain.” The woman is warm and familiarly appealing. The commercial ends with a close up of her smiling and stating: “If you have fibromyalgia ask your doctor if Lyrica is right for you.” The next commercial to air depicted a stylish and slim, silver-haired woman strolling through a beautifully restored section of New Orleans while apparently vacationing with her attractive and attentive silver-haired male companion. The

Fig. 1. “Overactive Nerves” Lyrica Commercial (Pfizer Inc., 2010a)

K.K. Barker / Social Science & Medicine 73 (2011) 833e842 837

commercial opens with the woman explaining, “My fibromyalgia muscle pain wasn’t something you could see, but I felt it all over. Some days I had to push myself to leave the house and do everyday things. Then my doctor told me about Lyrica.” This commercial introduces one of the cardinal features of the fibromyalgia illness experience, namely the consequences of living with an illness that is not visible to others. Fibromyalgia sufferers hate being told that they don’t look sick, because such comments implicitly or explicitly suggest they are mentally unstable or malingering (Barker, 2005).

This is especially noteworthy in the relationship to another element of these commercials. The women characters in both of these advertisements emphatically state, “Lyrica is not an anti- depressant.” Pfizer must understand the importance of empha- sizing this point as a way of affirming fibromyalgia sufferers and validating the diagnosis (i.e., Lyrica is not an anti-depressant ergo fibromyalgia is not a mental illness). Additionally, Pfizer is dis- tinguishing itself from its new competition. By the time the second of these ads aired, Cymbalta had received FDA approval for fibro- myalgia and Savella’s approval was imminent. Perhaps to further distance the disorder from depression, these two ads are far less dark and distressing in mood than is the original commercial. In contrast to the suffering woman sitting and reading from her diary, these commercials are literally “sunny” and more strongly empha- size the women’s improved function. By linking use of the drug to pleasurable leisure activities, the positive emotional appeal (Frosch et al., 2007) is more strongly conveyed in these ads than is the case in the original commercial. The active woman with fibromyalgia becomes even more central in the next wave of Lyrica commercials.

Two new commercials appeared in 2009. In both of these advertisements the women who are portrayed with fibromyalgia are at work. One commercial centers on a woman who looks as if she either owns or manages a high-end bakery. It opens with the women saying, “My muscles ached all over. I felt this deep, lingering pain that was a complete mystery to me. My doctor diagnosed it as fibromyalgia muscle pain and then he recom- mended Lyrica.” She goes on to explain, “Fibromyalgia is thought to be the result of overactive nerves that cause widespread pain. Lyrica is FDA approved to help relieve the unique pain of fibro- myalgia.” The woman is then shown warmly greeting her public and working long hours in order to create elaborate and beautiful confections. Now that she takes Lyrica, she explains, she has less pain and can do more. Surrounded by pastries of her own creation, she asks, “How sweet is that?”

The other 2009 commercial portrayed a university professor in an empty lecture hall at the end of her class session. The professor tells the television audience, “I had chronic muscle pain all over, and I was so tender to the touch, but I didn’t know why. My doctor diagnosed it as fibromyalgia and then he recommended Lyrica.” Like the baker who found her pain “a complete mystery,” this commercial addresses the lack of public awareness about fibro- myalgia; even a university professor was bewildered by her pain symptoms. Now, however, the professor educates the audience, using the same lines as the baker regarding “overactive nerves” and Lyrica’s ability to relieve the “unique pain” of fibromyalgia. Also like the ad featuring the hard-working baker, this commercial empha- sizes the transformative potential of the drug. With the professor’s voiceover listing the drug’s side effects, she is shown walking across campus with her briefcase in tow, smiling and greeting students, and joining colleagues for espresso at an outdoor cafe. The commercial ends with the professor asking the viewing audience: “Could your pain be caused by Fibromyalgia? Ask your doctor about Lyrica today.”

Like the previous commercials, these two follow the narrative outlined by Frosch et al. (2007) (control lost, control regained, and concomitant social rewards). But unlike the earlier versions, these

advertisements emphasize identifying one’s mysterious pain as fibromyalgia as an intervening step toward regaining control over one’s life. Whereas the narrative in the earlier commercials is premised on the assumption that the viewers, like the women portrayed, already have a fibromyalgia diagnosis, the women in these two commercials describe how their doctors diagnosed their inexplicable pain as fibromyalgia. The simple statement, “My doctor diagnosed it as fibromyalgia” grants both the diagnosis and the pain validity. Additionally, instead of telling the audience that fibromyalgia is a “real” condition and that Lyrica is “not an anti- depressant,” the women in these ads provide a brief medical explanation for fibromyalgia and explain how Lyrica relives the “unique pain” of fibromyalgia in medical terms. Both women are shown in demanding jobs, rather than reading from a diary, vacationing in New Orleans, or gardening, which lends additional symbolic credibility to these women’s explanation and experience of fibromyalgia. There are additional symbolic benefits of featuring women at work. In the same fashion that the advertising campaign counters the notion that women with fibromyalgia are imagining or exaggerating the symptoms, it must also counter the related notion that fibromyalgia sufferers are malingers. As portrayed, these women are not using a diagnosis to skirt workplace responsibilities.

The career woman and the medical science of fibromyalgia are also narrative elements in the final Lyrica commercial to air during the period studied. This commercial, which first aired in the spring of 2010, expands on the account of “overactive nerves” introduced by the baker and the professor (Pfizer Inc., 2010a). The commercial features a very chic and attractive woman fashion designer in her fifties. She is shown sketching the design for a dress, selecting and cutting the perfect fabric, and carefully fitting the garment on a youthful model. Prior to this, the woman touches her shoulder and the viewer sees a visual presentation of her muscles tissue; then, traveling into the central nervous system, the viewer sees an image meant to depict “overactive” neural firing upon which the word “FIBROMYALGIA” is superimposed (Fig. 1). With these images on the screen, the woman narrates:

� I had ongoing pain; a deep ache all over. I found out that connected to our muscles are nerves that send messages through the body. My doctor diagnosed it as fibromyalgia, thought to be the result of overactive nerves that cause chronic widespread pain. Lyrica is believed to calm these nerves. I learned Lyrica can provide significant relief from fibromyalgia pain. So now I can do more of what I love.

The commercial ends with the woman telling the viewing audience, “I found answers about fibromyalgia. Then I found Lyrica. Ask your doctor about Lyrica today.” Along with depicting the pre- Lyrica limitations and the post-Lyrica freedoms, this commercial

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strongly emphasizes the importance of becoming aware of fibro- myalgia as part of this transformation. Among other things, this makes clear that, like the ads featuring the baker and professor, the principal target audience are individuals who are not yet diagnosed with fibromyalgia and may have never heard of the diagnosis before.

A particularly noteworthy aspect of this ad is its use of a visual image to depict the bodily mechanisms said to underlie the disorder. The image promotes the theory that fibromyalgia is a neurochemical aberration referred to as central sensitization. Using a visual image to represent a disease that in fact lacks any visible biomedical properties is a potent symbolic strategy. After all, scientific imagery and biomedical authority go hand in hand (Joyce, 2008). Although the image is merely a dramatization, it seems intended to look real (i.e., a high-tech image of disordered neural functioning) and viewers are likely to believe that they are actually looking at the organic basis of fibromyalgia. The important cultural association between biomedical visibility and reality is well deployed by Pfizer with the result that this 60-second commercial implicitly confirms the existence of fibromyalgia.

The DTCA campaign for Lyrica has evolved since the first commercial appeared in 2007. Nevertheless, some of the campaign’s elements have remained consistent. Without question, the pharmaceutical resurrection that allows the individual to become more active, is the dominant narrative thread in all six commercials. Applicable here is the concern of many clinicians and scholars that DTCA suggests that the ability to work and play hard and live a happier life is just a prescription away (Fox & Ward, 2008). Extrapolating from clinical trials, Lyrica does provide some symptom relief for some people. As observed in other DTCA campaigns, however, the Lyrica ads portray the best-case scenario rather than the average benefit to the average person (Frosch et al., 2007). Accentuating positive outcomes is likely to result in unre- alistic expectations on the part of some consumers and also to lead them to deemphasize potential adverse reactions. The use of slender women in all of the commercials, for instance, counters one of the most common side effects of Lyrica, significant weight gain. In the commercial featuring the professor, at the exact second that “suicidal thoughts and tendencies” are listed as a possible side effect, the screen fills with a burst of glorious sunshine coming through the trees engulfing the professor in a warm glow. This cannot be a coincidence and it seems troublingly manipulative given the desperation for relief among chronic pain sufferers.

The status of fibromyalgia as a “real” illness (i.e., not a mental illness) has also been a prominent feature of the DTCA campaign for Lyrica from the onset. In the earlier commercials Pfizer disassoci- ates Lyrica from anti-depressants in an effort to conceptually distinguish fibromyalgia from a mental illness designation. The later commercials promote the theory that fibromyalgia is a disorder of central sensitization, eventually using imagery to connote its organic nature. By having the women explain that their heretofore mysterious pain was diagnosed as fibromyalgia by their doctors, the later commercials add a new narrative element to bolster fibromyalgia’s diagnostic legitimacy. By featuring women in the workplace, the latter commercials also symbolically assert that fibromyalgics are not malingers. At each step, the process of legit- imating fibromyalgia in the DTCA campaign has been fundamen- tally tied to the feminization of the disorder. On one hand the very premise of the campaign, that fibromyalgia is a real disorder, vali- dates women’s experience, even if used as a tactic for tapping into a lucrative market. On the other hand, in an effort to portray the women as credible and the drug as effective, the campaign’s representation of fibromyalgia bears little resemblance to the reality of fibromyalgia for most sufferers. The gulf between fibro- myalgia as represented in DTCA and as a lived experience will be addressed in more detail later in the paper.

These efforts on the part of Pfizer to legitimate fibromyalgia in effect pick up where the ACR criteria left off with respect to advancing fibromyalgia toward a more fully accepted medical phenomenon. Whether or not Lyrica can complete what has thus far been a partial medicalization of the fibromyalgia diagnosis, sales of the drug shot up dramatically in the wake of the FDA approval. The 2007 revenues for Lyrica were $1.8 billion, an increase of 58 percent from the previous year (i.e., prior to the drug’s approval for fibromyalgia). Sales in 2008 and 2009 also increased dramatically ($2.6 and $2.8 billion respectively). In 2009, the only Pfizer drug with higher revenues than Lyrica was Lipitor. Lyrica sales even outpaced those of the company’s highly visible blockbuster Viagra (Pfizer Inc., 2008, 2009, 2010b). Industry experts predict continued robust increases through 2018, aided in no small part by Pfizer’s DTCA campaign (Hohenberg et al., 2007). These numbers are impressive but they only tell us part of the story. I now examine the response of fibromyalgia sufferers to Lyrica.

Pharmaceutical optimism: a drug of one’s own

One of the most important observations about posts to Fibro Spot concerning Lyrica (pregabalin) is that they began to appear several years before the drug received FDA approval for any indi- cation. There are posts, for example, summarizing a clinical trial of pregabalin for fibromyalgia in 2004; posts announcing the FDA approval of the drug for the treatment of neuropathic pain disor- ders in 2005; and then a flurry of posts from individuals reporting back to the group about their own experience taking the drug on an off-label basis prior to its subsequent approval for fibromyalgia in June 2007. This is an important observation because it makes clear that participants at Fibro Spot did not learn about Lyrica from the DTCA campaign. Instead, they had been eagerly following the development of this new drug option for years. This fact requires an appreciation of the overwhelming symptom experience of fibro- myalgia, the condition’s exceedingly poor response to existing medical treatments, and the desperation many sufferers feel for some symptom abatement. In this regard their interest in pre- gabalin was no different than their interest in any promising drug treatment option on the horizon.

Even though Lyrica was already on the radar of many Fibro Spot participants, they were nevertheless enthusiastic about the drug’s approval for fibromyalgia. In the eyes of most sufferers and advo- cates, the FDA approval represented a tremendous victory. Fibro- myalgia advocacy groups, like the National Fibromyalgia Association (NFA), marked the event as an important step toward destigmatizing the condition and those it afflicts. Lynn Matallana, the NFA President was quoted in the New York Times: “The day that the F.D.A. approved a drug and we had a public service announcement, my pain became real to people” (Berenson, 2008). President Matallana also posted the following statement on the NFA website announcing the FDA approval of Lyrica:

� The National Fibromyalgia Association has been working for over ten years to raise awareness of fibromyalgia and its debilitating chronic pain that affects the lives of 6 to 10 million people in the United States. During that time, we have also been hoping and waiting to have an effective drug treatment approved by the FDA specifically for fibromyalgia so that we no longer have to hear our health care providers tell us “there is nothing I can do for you,” or worse, the pain is “all in your head.” .[N]ow more than ever we are hopeful that public and medical awareness will improve and patients will have an effective treatment that could help reduce their suffering. The future is bright indeed (Matallana, 2007).

K.K. Barker / Social Science & Medicine 73 (2011) 833e842 839

Like Matallana’s NFA statement, posts on Fibro Spot similarly capture the felt significance of having a drug of one’s own. The following exchange is illustrative in this regard:

� A huge step for FM was made today. The NFA posted an article that today a drug was approved by the FDA for the treatment of FM, Lyrica. Progress is being made!

� [A]bout LYRICA, i tried it some time ago and it didn’t help me but hopefully it helps others. at least there is a drug being used to help some people with FIBROMYALGIA. may be people will now understand that it is real and not just in our heads.

� Thanks so much for the news about Lyrica. May be now that there is a drug for it, docs will take fibro more seriously.

These and other posts foreground the meaning of a fibromyalgia drug in terms of potential therapeutic progress, diagnostic accep- tance, illness recognition, and personal validation. Even individuals who know the drug offers them no therapeutic hope recognize Lyrica as a symbolic victory. As gleefully noted by one poster, the general public is likely to conclude that, “[i]f there is a medication for it then it MUST be real!”

When the first Lyrica television commercial aired it was an instant topic on Fibro Spot. Participants were quick to realize that the DTCA campaign could do more to spread the word about fibromyalgia than all their previous efforts to explain their invisible illness to doctors, family, and friends. The following post from Fibro Spot captures the reaction of many participants, as well as the general buzz at other online fibromyalgia communities.

� I just HAD to tell you all that in the last week I had 2, yes 2 people ask me about my fibro. They said they did not know it was a real disease until they saw the commercial about Lyrica! Its not enough for US to tell them. Noooooooo.they have to see it on TV. [.] We have been telling the truth to family and friends forever. [.] I think that Lyrica commercial is going to be one of the best things that ever happened to us.whether the med helps or not. It somehow validates us as human beings that have a debilitating illness not just the hypochondriacs they thought we were!

Lyrica commercials, it seems, are more capable of speaking authoritatively about the reality of fibromyalgia than are sufferers. Similarly hopeful, another participant applauded the advertise- ment for its ability to “help us with those who do not recognize our ‘silent illness.’”

These comments concerning the FDA approval Lyrica for the treatment of fibromyalgia and the ensuing DTCA campaign make clear that Fibro Spot participants hope that the approval and marketing of a prescription medication can do what has not yet been accomplished. Namely, legitimize the fibromyalgia diagnosis and corroborate their suffering. This route to diagnostic and personal validation hinges on whether the medical community and the general public will listen to Lyrica; that is, endow a prescription medication with the cultural authority to define what is medically real. In this regard, the actual force of pharmaceutical determinism remains to be seen. It is, however, already clear that the portrayal of fibromyalgia advanced by Pfizer is seen as problematic in the eyes of many sufferers.

Pharmaceutical Realism: the limitations of Lyrica and its DTCA representation

Shortly after these data were collected, Fibro Spot, which had been in existence for more than a decade, disappeared. Ironically, in a previous article I noted that Fibro Spot had remarkable staying

power among online illness support groups (Barker, 2008). Although the group membership was still strong, the world of online illness support has changed dramatically in the last several years. It has become more concentrated and corporately backed (e.g., Web M.D.) and has also moved onto social networking sites (e.g., Facebook). One can assume that some Fibro Spot members dispersed to better-financed forums and those hosted on newer technological platforms. Unfortunately, this makes tracking their responses to the evolving DTCA campaign for Lyrica impossible.

One can, however, readily gauge the reactions to the Lyrica commercials as expressed by fibromyalgia sufferers in a number of online venues. The early response shared the same optimism expressed at Fibro Spot that the commercials are getting the word out and increasing awareness about fibromyalgia. But this hope quickly gave way to heated criticism. As is plainly evident in the posts on Fibro Spot, sufferers want the commercials to do much more than sell a new drug to treat fibromyalgia through the use of glamorous images and exaggerated claims. Among other things they want the commercials to accurately explain the experience of fibromyalgia to the general public and silence medical skeptics. On this score the DTCA campaign is judged to be an utter failure. There is widespread anger that the women depicted with fibromyalgia in the commercials are too beautiful, too fit, too active, and too transformed by the medication. One fibromyalgia blogger captured the opinion of many when she asked, “So, where does the middle- aged frump (me) see herself in this ad?” (http://eclecticwoman. wordpress.com).

But, by far the most intense criticism of the advertising campaign emphasizes its perceived gross mischaracterization of fibromyalgia. The commercials, many bemoan, give the troubling impression that fibromyalgia is something akin to a headache; a minor ailment that is easily and fully remedied by a single pill. It takes only a few minutes of online searching to tap into the widespread outrage at the implication that Lyrica will miraculously restore their health and allow them to reclaim an active lifestyle. The following comments mirror those of many others:

� I hate the TV commercials on Lyrica because it makes it seem that ‘if you take Lyrica you can live a normal life’ What a bunch of crap!” (http://www.healthcentral.com/chronic-pain/c/ 365418/110033/comments/).

� It’s a horrible drug with a misleading commercial showing women still working and enjoying life when there is no enjoying life with Fibro (http://forums.commercialsihate.com/ forum_posts.asp?TID¼5825)

Posts and comments from a variety of forums suggest that the commercials should depict real fibromyalgia sufferers sharing their actual experiences with the drug. The following blog post uses humor to make the point:

� Let’s all get together and make a real Fibro commercial, it would take them months to videotape us getting out of bed, trying to open soda cans or jars, trying to go to work, do our hair or get dressed, trying to sleep. They would give up filming us after about a week of it!! (http://eclecticwoman. wordpress.com)

There were also a number of suggestions, some tongue-in-cheek, for commercials that portrayed the potential side effects of the drug, such as showing women made so fatigued they cannot get out of bed, so dizzy they cannot walk in a straight line, and so bloated and overweight they cannot move.

There is well-founded concern that when DTCA campaigns accentuate positive outcomes, as they invariably do, some

K.K. Barker / Social Science & Medicine 73 (2011) 833e842840

consumers develop inflated expectations about what the drug can accomplish (Frosch et al., 2007). What stands out in this case is how strongly fibromyalgia sufferers resent that the commercials create an unrealistic public expectation about what both Lyrica and they themselves can do. The following comments describe the situation this way:

� “[H]ow many people believe those commercials. I hear that all the time. ‘Why don’t you just take that Lyrica pill, you will feel better in no time.’ Yeah, right!” (http://www.prohealth.com/ me-cfs/blog/boardDetail.cfm?id¼1257217).

� “I hate that commercial. It makes most of my friends/family think I can swallow a pill and be healed. Very misleading” (http://www.facebook.com/topic.php? uid¼321530056520&topic¼12165).

Of course what is so troubling to sufferers about this disjuncture is that it reconnects with their long-standing struggles to have their illness taken seriously. If Lyrica does not restore them to health, as seen on television, and in the vast majority of cases it will not, this could be used to confirm that their problem is all in their head, that they are hysterical, or that they do not want to get better. The following comments are illustrative of what sufferers think:

� I was saddened by these commercials because they hawk a “miracle” that just doesn’t exist, they give a false impression of what the pills actually do, they give the uninformed/ uncaring people in my life yet more misguided ideas about how I am “not really trying”.I agree that these ads are a complete and utter joke and do more harm than good (http://www. wearefibro.org/michellehamilton/discussions/837).

� These commercials are completely unrealistic and unfortu- nately people believe what they see on TV. My family sees a commercial like this and they believe this one little pill will fix me. And if it doesn’t then I either must be exaggerating or it’s somehow my fault that I’m not getting better (http://www. dailystrength.org/c/Fibromyalgia/forum/9639628-another- new-commercial-lyrica).

These angry comments reveal a critical stance toward pharma- ceutical advertising. Very few of the women, even among those who had not tried the medication, were passively or uncritically “buying” the advertised message.

Juxtaposed to these comments concerning the DTCA campaign, are the experiences of those who were taking or had taken Lyrica. As noted there were posts on Fibro Spot reporting individual results of pregabalin (Lyrica) use years before the drug’s approval for fibromyalgia. Motivated in no small part by the near total ineffec- tiveness of existing treatment options, a number of Fibro Spot participants started taking Lyrica on an off-label basis shortly after it was approved for neuropathic pain disorders in 2004. As is the custom at Fibro Spot, members reported back to the group about their new drug ventures. From the beginning the accounts of their use of Lyrica were fairly tempered.

Their stories can be summarized thusly: a very small number of success stories, some of which turned out to be short lived, a few reports modest lackluster benefits, more accounts of insignificant benefits, and numerous chronicles of side effects, most often resulting in discontinued use. One woman who had been taking the drug for a year said it worked better than anything she tried: “It isn’t a cure all” but, without it she continued, “I wouldn’t be able to get out of bed in the a.m.” The most positive testimonial came from a woman who described Lyrica as “a miracle drug.” Prior to taking the drug her pain was so severe she was unable to function even on high doses of narcotic pain medications. After being on Lyrica for

just over a month, she was able to bake bread with her grand- children and join a gym. Unfortunately two months later she reported that her miracle drug was no longer providing her with any relief. Others described the all-too-common experience of the drug working for a while, only to wear off:

� I’ve tried the Lyrica, it was like a miracle drug the first three weeks. Then the dragon symptoms slowly crept back in to the point where they were before. [.] That’s not saying it won’t help someone else. I pray that it does. At least the word is getting out there that FM is a real disorder, and not “all in our heads.”

A number of women reported significant pain reduction, but at the expense of side effects that they found simply too much to endure.

� I was just on Lyrica. Love it. No pain for weeks. So good I made all kinds of excuses as to why I was turning red and itching everywhere. Had bumps start showing up and becoming sores. Told everyone (including me) it must be the cats. Never allergic to them before but what the hell. Finally feet and hands swelled up and doc took me off med.

The views expressed on Fibro Spot concerning the drugs efficacy parallels that seen on other online venues. There are a small number of individuals who report benefits with Lyrica, most often in combination with several other drugs; and, even then, the gains sometimes come with significant side effects. There are a few reports of a modest reduction in pain, many reports of no improvement at all, and a catalog of complaints including fatigue, weight gain, vertigo, hallucinations, mental confusion, painful swelling of hands and feet, itching and rashes, and suicidal thoughts. Even taking into consideration the few individuals who describe Lyrica as “a miracle drug” or “life saver,” there is no evidence found online of lives transformed as radically as seen in the best-case scenarios portrayed in the televisions commercials.

Obviously the posts on Fibro Spot and a perusal of online chat is no substitute for randomized, double-blind, placebo-controlled clinical studies. In general, these online comments are not incom- mensurate with the findings from the two clinical trials used to support the FDA approval of Lyrica. These studies, which were subsequently published in 2008, found non-dramatic but statisti- cally significant improvements in pain and other fibromyalgia symptoms between patients on pregabalin compared to those taking a placebo. In one study, the difference in self-reported pain ratings between these groups was 4.66 vs. 5.64 on a scale of 0 (no pain) to 10 (worst possible pain) (Arnold et al., 2008). This study also found that those on pregabalin had improved scores on a widely used patient scale or questionnaire designed to evaluate the impact of symptoms on overall level of functioning, but found no such improvements in scores on another commonly used patient ques- tionnaire. The other study’s primary outcome measure was the length of time patients reported some therapeutic response. The main finding: “[P]regabalin was associated with a significantly longer time to worsening than was placebo” in terms of reported pain level and some other fibromyalgia symptoms including fatigue and sleep disturbances (Crofford et al., 2008: 429). In other words, it took longer for any meaningful benefits of the drug to wear off than it took for any meaningful benefits of the placebo to wear off. Even these nominal differences between treatment and placebo groups in these studies, however, may be partly a methodological artifact. The first study excluded individuals who did not respond favorably to the drug in a short trial phase of the study prior to randomizing subjects into the treatment and placebo groups. The second study

K.K. Barker / Social Science & Medicine 73 (2011) 833e842 841

excluded individuals who were “placebo responders” during a one- week phase of the study prior to randomizing individuals into the treatment and placebo groups. By removing the individuals not likely to respond to the drug in one case, and those most likely to respond to the placebo in the other case, researchers maximized the probability of demonstrating the drug’s efficacy compared to a placebo. Both studies were funded by Pfizer.

Discussion

Although the pharmaceutical industry did not play a central role in creating the fibromyalgia diagnosis, it has become instrumental in its promotion and promises to become even more so in the immediate future. After the establishment of the ACR criteria, pharmaceutical companies seeded peer-reviewed clinical research that resulted in the criteria’s propagation (Hadler & Greenhalgh, 2005). In addition, the pharmaceutical industry has supported fibro-friendly physicians and sponsored physician education about fibromyalgia. All of these efforts have been aimed at convincing physicians that fibromyalgia is a discrete disease entity. This strategy has met with only limited success; many physicians are not yet persuaded (Wolfe, 2009).

The DTCA campaign for Lyrica and the campaigns for other fibromyalgia drugs that will soon follow, represent the next phase in the promotion of the fibromyalgia diagnosis. There is much riding on Lyrica. Not just because fibromyalgia sufferers long for some symptom relief, but also because the very existence of approved drugs shores up a biomedical account of the disorder. Rather than a collection of pills for a collection of ill-defined symptoms, Lyrica contributes to the reification of fibromyalgia. As new drugs receive FDA approval for fibromyalgia and other con- tested diagnoses, the logic of pharmaceutical determinism will similarly reveal itself. That is, a central rhetorical feature in the DTCA campaign for these drugs is bound to use the existence of an approved medication to corroborate the existence of the contested condition itself. Pharmaceutical companies are likely to market medications targeted at conceptually peeling off many contested illnesses currently lumped together as functional somatic disorders in the medical literature.

Even though Pfizer’s promotion of the fibromyalgia diagnosis endorses its drug and increasing its profits, in the process it threatens to discredit the suffering of individuals with fibromyalgia. In this way, the DTCA campaign is both a blessing and a curse in the eyes of those already diagnosed. Getting the word out about fibromyalgia has long been seen as a necessary step toward legiti- mization, but getting the wrong word out is not what most would have hoped for. Although sufferers might have been able to over- look the fact that the women featured in the Lyrica ads are beautiful and bourgeois, it is more difficult to overlook the fact that the commercials portray fibromyalgia as a condition that is readily overcome. While it’s easy to understand why sufferers hoped that Lyrica could vindicate them, depicting their disease as an unre- lenting and encumbering condition, even when tempered by the medication, would not be a lucrative marketing strategy. So it is that the result of the DTCA for Lyrica is that it simultaneously medicalizes and trivializes women’s suffering. The gap between the DTCA portrayal of fibromyalgia and the reality of fibromyalgia can be discrediting. The commercials threaten to cast any individual sufferer who continues to be mired in her illness, given the avail- ability of this proven medication, as hysterical. Pharmaceutical determinism, therefore, may bolster the cultural creditability of a diagnostic category and still fail to validate an individual’s illness experience.

The Lyrica campaign is apt to contribute to medicalization by producing a new cohort of fibromyalgics. The more recent

commercials target those not yet diagnosed by encouraging primarily middle-aged women to indentify their common symp- toms as fibromyalgia. Symptoms do not a disease make; and, yet, when it comes to medically unexplained symptoms “society does not readily grant permission to be ill in the absence of disease” (Nettleton, 2006: 1167). The DTCA commercials for Lyrica d and those for future drugs targeting contested illnesses d will simply provide a new venue for access to diagnoses for which there is already considerable hunger. Because they have more health complaints then their male counterparts, women are more likely to identify with DTCA narratives that suggest that their pain, fatigue, and othercommon symptoms are signs of particulardisease entities. If asking your doctor for a specific diagnosis is akin to asking him or her for a specific prescription medication, physicians are likely to comply. Their compliance is even more likely given that the diag- nostic criteria are so accommodating that it is essentially impossible not to diagnose every patient who reports widespread pain of unknown origins with fibromyalgia (Cohen,1999). Furthermore, the fact of the matter is that these drugs are a boon to health care providers and institutions. Contested illness patients are notoriously time and resource intensive in institutional settings where time is a premium and resources are managed (Barsky & Borus,1995). New medications targeting this difficult population give clinicians something to offer their beleaguered patients that is relatively cost and time effective, even if it may not be particularly therapeutically effective. The approval of drugs for contested illnesses will thus encourage skeptical physicians and cynical managed care organi- zations to contribute to the propagation of these diagnoses. The analysis presented here strongly suggests such outcomes but research assessing the empirical relationship between DTCA and increases in contested illness diagnoses is necessary.

The above observations draw our attention to the complex character of pharmaceutical determinism as played out in this case. The logic of pharmaceutical determinism encourages sufferers to experience the FDA approval of Lyrica for the treatment of fibro- myalgia as an unambiguous victory; this, despite their anger at or critical stance toward the DTCA campaign, or their personal expe- rience of the drug’s limited effectiveness or concomitant side effects. Clinician’s interpretations and actions are likewise shaped by the mere existence of Lyrica as an approved drug for fibro- myalgia. In other words, the deterministic capacities of pharma- ceuticals (i.e., subsequent beliefs and actions are determined by the existence of a drug) are at work even when the key players e patient consumers and clinicians e have a host of misgivings about the pharmaceuticals and diagnoses in question.

The medicalization of women’s distress under the rubric of fibromyalgia has been woefully ineffective. Fibromyalgia has not responded well to medical management (Goldenberg et al., 2004; Wolfe & Michaud, 2009). It seems unlikely that any medical inter- vention, including pharmaceuticals, will offer significant relief to a considerable number of individuals diagnosed with fibromyalgia. This is not because those with fibromyalgia are hysterics or malingers, but because fibromyalgia is a conceptual label applied to so many common symptoms whose origins are varied and complex. I am not suggesting that women’s common symptoms are incon- sequently or insufficiently worthy of redress. The important point is to recognize the consequences and limitations of framing women’s common distress as a discrete disease entity. Fibromyalgia sufferers and advocates promote the theory that fibromyalgia is a neuro- chemical aberration and now point to the FDA approval of Lyrica to support this conclusion. However, this theory of fibromyalgia cannot account for the disorder’s overwhelming feminization (Barker, 2005). Here the insights of feminist scholars vis-à-vis medicalization are indispensable. When we define women’s problems as medical in nature, we disregard the fact that gender

K.K. Barker / Social Science & Medicine 73 (2011) 833e842842

practices and gender inequality negatively impact women’s health in myriad ways (Doyal, 1995; Lorber, 1997; Ruzek, Olsen, & Clarke, 1997). Pharmaceutical determinism continues the trend of defining women’s distress in narrow medical terms and pharma- ceuticals will continue to be a poor remedy for the complex processes that translate into women’s high rates of morbidity. If the goal is to lessen the suffering that characterizes fibromyalgia, our failure to be attentive to these realities will be one of the most regrettable outcomes of listening to Lyrica.

Acknowledgments

The author thanks Tasha Galardi, Val Burris, four anonymous reviewers, and the guest editors of this special issue for their comments and feedback.

References

Angell, M. (2004). The truth about the drug companies: how they deceive us and what to do about it. New York: Random House.

Arnold, L. M., Russell, I. J., Diri, E. W., Duan, W. R., Young, J. P. J., Sharma, U., et al. (2008). A 14-week, randomized, double-blinded, placebo-controlled mono- therapy trial of pregabalin in patients with fibromyalgia. The Journal of Pain, 9(9), 792e805.

Barker, K. (2005). The fibromyalgia story: medical authority and women’s worlds of pain. Philadelphia: Temple University Press.

Barker, K. (2008). Electronic support groups, patient-consumers, and medicalization: the case of contested illness. Journal of Health and Social Behavior, 49(1), 20e36.

Barsky, A., & Borus, J. (1995). Somatization and medicalization in the era of managed care. JAMA, 274(24), 1931e1934.

Barsky, A., & Borus, J. (1999). Functional somatic syndromes. Annals of Internal Medicine, 130(11), 910e921.

Berenson, A. (2008). Drug approved. is disease real. Retrieved. The New York Times. http://www.nytimes.com/2008/01/14/health/14pain.html? _r¼1&em&ex¼1200459600&en¼bac45d5aff5a17d7&ei¼5087% 250A&oref¼slogin.

Bird, C., & Rieker, P. P. (2008). Gender and health: the effects of constrained choice and social policies. New York: Cambridge University Press.

Bonaccorso, S. N., & Sturchio, J. L. (2002). Direct to consumer advertising is medi- calising normal human experience, against. British Medical Journal, 324, 910e911.

Cohen, M. (1999). Is fibromyalgia a distinct clinical entity? The disapproving rheumatologist’s evidence. Bailliere’s Clinical Rheumatology, 12(3), 421e425.

Conrad, P. (2005). The shifting engines of medicalization. Journal of Health and Social Behavior, 46, 3e14.

Conrad, P. (2007). The medicalization of society: on the transformation of human conditions into treatable disorders. Baltimore, Maryland: The Johns Hopkins University Press.

Conrad, P., & Leiter, V. (2008). From Lydia Pinkham to Queen Levitra: direct-to- consumer advertising and medicalisation. Sociology of Health and Illness, 30(6), 825e838.

Conrad, P., & Stults, C. (2008). Contestation and medicalization. In P. Moss, & K. Teghtsoonian (Eds.), Contesting illness: Processes and practice (pp. 323e335). Toronto: University of Toronto Press.

Crofford, L. J., Mease, P. J., Simpson, S. L., Young, J. P. J., Martin, S. A., Haig, G. M., et al. (2008). Fibromyalgia relapse evaluation and efficacy for durability of mean- ingful relief (FREEDOM): a 6-month, double-blind, placebo-controlled trial with pregabalin. Pain, 136(3), 419e431.

Crofford, L. J., Rowbotham, M. C., Mease, P. J., Russell, I. J., Dworkin, R. H., Corbin, A. E., et al. (2005). Pregabalin for the treatment of fibromyalgia syndrome: Results of a randomized, double-blind, placebo-controlled trial. Arthritis and Rheumatism, 52(4).

Csillag, C. (1992). Fibromyalgia: The Copenhagen declaration. Lancet, 340(8820), 663e664.

Davis, J. E. (2009). Medicalization, social control, and the relief of suffering. In W. C. Cockerham (Ed.), The new blackwell companion to medical sociology (pp. 211e241). Malden, MA: Blackwell Publishers.

Donohue, J. M., Cevasco, M., & Rosenthal, M. B. (2007). A decade of direct-to- consumer advertising of prescription drugs. The New England Journal of Medi- cine, 357(7), 673e681.

Doyal, L. (1995). What makes women sick: gender and the political economy of health. New Brunswick, NJ: Rutgers University Press.

Fox, N. J., & Ward, K. J. (2008). Pharma in the bedroom. and the kitchen. The phar- maceuticalisation of daily life. Sociology of Health and Illness, 30(6), 856e868.

Frosch, D. L., Krueger, P. M., Hornik, R. C., Cronholm, P. F., & Barg, F. K. (2007). Creating demand for prescription drugs: a content analysis of television direct- to-consumer advertising. Annals of Family Medicine, 5(1), 6e13.

Goldenberg, D. L., Burckhardt, C., & Crofford, L. J. (2004). Management of fibro- myalgia syndrome. Journal of the American Medical Association(JAMA), 292, 2388e2395.

Greene, J. (2007). Prescribing by the numbers: drugs and the definition of disease. Baltimore, MD: The Johns Hopkins University Press.

Hadler, N. M. (1997). La maladie est morte, vive le malade. [The disease is dead, long live the disease]. Journal of Rheumatology, 24(7), 1250e1251.

Hadler, N. M., & Greenhalgh, S. (2005). Labeling woefulness: the social construction of fibromyalgia. Spine, 30, 1e4.

Hohenberg, K. W., Wilson, A., Daley, T. L., & Fam,S. R. (2007). Fibromyalgia. http://www. dresources.com/Products-and-Services/Report?r¼pcorpn0108 Waltham, MA.

Joyce, K. A. (2008). Magnetic appeal: MRI and the myth of transparency. Ithaca, NY: Cornell University Press.

Jutel, A. (2009). Sociology of diagnosis: a preliminary review. Sociology of Health and Illness, 31(2), 278e299.

Lakoff, A. (2006). Pharmaceutical reason: knowledge and value in global psychiatry. Cambridge: Cambridge University Press.

Loe, M. (2004). The rise of viagra: how the little blue pill changed sex in America. New York: New York University Press.

Lorber, J. (1997). Gender and the social construction of illness. Thousand Oaks, CA: Sage Publishing.

Manu, P. (2004). The psychopathology of functional somatic syndromes: neurobiology and illness behavior in chronic fatigue syndrome, fibromyalgia, gulf war illness, irritable bowel, and premenstrual dysphoria. New York: Haworth Medical Press.

Matallana, L. (2007). National fibromyalgia association applauds FDA approval of lyrica. Retrieved on June 5, 2010. National Fibromyalgia Association. http:// www.fmaware.org/site/News2?page¼NewsArticle&id¼5632.

Milton, C. (1999). Is fibromyalgia a distinct clinical entity? The disapproving rheumatologist’s evidence. Bailliere’s Clinical Rheumatology, 13(3), 421e425.

Mintzes, B. (2002). Direct to consumer advertising is medicalising normal human experience, for. British Medical Journal, 324, 908e911.

Mintzes, B., Barer, M. L., Kravitz, R. L., Kazanjian, A., Bassett, K., Lexchin, J, et al. (2002). Influence of direct to consumer pharmaceutical advertising and patients’ requests on prescribing decisions: two site cross sectional survey. British Medical Journal, 324, 278e279.

Moss, P., & Teghtsoonian, K. (2008). Contesting illness: processes and practices. Toronto: University of Toronto Press.

Moynihan, R., & Cassels, A. (2005). Selling sickness: how the world’s biggest phar- maceutical companies are turning us all into patients. New York: Nation Books.

Moynihan, R., Heath, I., & Henry, D. (2002). ‘Selling sickness’: the pharmaceutical industry and disease mongering. British Medical Journal, 324, 886e891.

National Fibromyalgia Association. (2007). Facing fibromyalgia, finding hope. Nettleton, S. (2006). ‘I just want permission to be ill’: towards a sociology of

medically unexplained symptoms. Social Science & Medicine, 62(5), 1167e1178. Neumann, L., & Buskila, D. (2003). Epidemiology of fibromyalgia. Current Pain and

Headache Reports, 7(5), 362e368. O’Reilly, C., & Capaccio, T. (2009). Pfizer agrees to record criminal fine in fraud probe.

Bloomberg.com. Payer, L. (1992). Disease-mongers: how doctors, drug companies, and insurers are

making you feel sick. New York: John Wiley and Sons, Inc. Pfizer Inc. (2008). Pfizer 2007 annual report. New York. Pfizer Inc. (2009). Pfizer 2008 annual report. New York. Pfizer Inc. (2010a). Lyrica, television commercial. http://www.lyrica.com/

fibromyalgia_tv_commercial.aspx New York. Pfizer Inc. (2010b). Pfizer 2009 annual report. New York. Recla, J. M. (2010). New and emerging therapeutic agents for the treatment of

fibromyalgia: an update. Journal of Pain Research, 22(3), 89e103. Riessman, C. K. (2008). Narrative methods for the human sciences. Thousand Oaks,

CA: Sage. Ruzek, S. B., Olsen, V., & Clarke, A. (1997). Women’s health: complexities and differ-

ences. Columbus, OH: Ohio State University Press. Showalter, E. (1997). Hystories: hysterical epidemics and modern media. New York:

Columbia University Press. Spencer, L., Ritchie, J., & O’Connor, W. (2003). Analysis: practices, principles and

processes. In J. Ritchie, & J. Lewis (Eds.), Qualitative research practice (pp. 199e218). Thousand Oaks, CA: Sage.

Tiefer, L. (2006). Female sexual dysfunction: a case study of disease mongering and activist resistance. PLoS Med, 3(4), e178.

Wessley, S., Nimnuan, C., & Sharpe, M. (1999). Functional somatic syndromes: one or many? The Lancet, 354(9182), 936e939.

Williams, S. J., Gabe, J., & Davis, P. (2008). The sociology of pharmaceuticals: progress and prospects. Sociology of Health and Illness, 30(6), 813e824.

Williams, S. J., Seale, C., Boden, S., Lowe, P., & Steinberg, D. L. (2008). Waking up to sleepiness: modafinial, the media and the pharmaceuticalisation of everyday/ night life. Sociology of Health and Illness, 30(6), 830e855.

Wolfe, F. (2009). Fibromyalgia wars. The Journal of Rheumatology, 36(4), 671e678.

Wolfe, F., Clauw, D. J., Fitzcharles, M. A., Goldenberg, D. L., Katz, R. S., Mease, P., et al. (2010). The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Research, 62(5), 600e610.

Wolfe, F., & Michaud, K. (2009). Outcome and predictor relationships in fibro- myalgia and rheumatoid arthritis: evidence concerning the continuum versus discrete disorder hypothesis. Journal of Rheumatology, 36(4), 831e836.

Wolfe, F., Smythe, H., Yunus, M., Bennett, R., Bombardier, C., Goldenberg, D., et al. (1990). The American College of Rheumatology 1990 criteria for the classifi- cation of fibromyalgia. Arthritis and Rheumatism, 33(2), 160e172.

Cancer-diagnosis-as-discursive-capture--Phenomenological-re_2011_Social-Scie.pdf

• Cancer diagnosis as discursive capture: Phenomenological repercussions of being positioned within dominant constructions of ...
• Introduction
• The role of diagnosis
• The role of discourse
• Discursive constructions of cancer and its meanings
• The cultural imperative to ‘Think Positively’
• Cancer as a moral concern
• Phenomenological repercussions
• Engaging with suffering and mortality
• Managing responsibility
• The struggle for meaning
• The experience of being constructed by and positioned within cancer discourse
• The (social, historical, cultural) context in which meaning is made
• Conclusion
• Acknowledgements
• References