Before you sell a drug, you have to sell the disease. And never was this truer than for social anxiety disorder.1 The moment the American Psychiatric Association, calling it an underreported problem, it not only defined a new segment of the population as ill but also cast their woes in an entirely different form. A signal therefore went out that researchers, mental health professionals, and the drug companies should unearth fresh remedies. These had to fit the APA'S newfound biological emphases, adopted almost wholesale from nineteenth-century models of pathology. Psychiatry also freed itself to partner with pharmacology (and so treat social phobia mostly with drugs) by dismissing psychoanalysis as costly and ineffective. 2
What Robert Spitzer's task forces began, in terms of redefining mental disorders, the pharmaceutical companies soon completed. For by splitting anxious and phobic reactions into seven new disorders, the DSM at a stroke had greatly expanded the market of potential clients. The task forces had also given social phobia a more patient-friendly name and helpfully lowered its diagnostic threshold. The numbers of patients potentially affected skyrocketed (Murray Stein put the upper ceiling at almost one in five),3 but the pharmaceutical giants decided even more needed to be done.
As the trade journal PR News announced quite candidly, the British firm Smith-Kline Beecham resolved to "position social anxiety disorder" as "a severe medical condition."4 The company's internal memos confirm that it was going all-out on this front, representing Paxil (paroxetine hydrochloride) as the sole means of treating a "highly debilitating" illness.5 "Efforts [were] concentrated," a confidential report confirmed in 1998, on Smith-Kline's having "the first SSRI approved for social phobia/social anxiety disorder, an anxiety disorder with enormous potential."6
To reach this goal, the company needed to raise the malady's profile, so it ratcheted up the plight of the socially anxious and stressed the maximum number said to be afflicted.7 "What these companies do," notes Isaac Marks, "is say, 'Gee, here's this undertreated, under recognized problem, and we really want to show you how common this disorder is in the community, and all these poor people are suffering when they could benefit from our drugs.' ... It's an advertising ploy, and this has been done for other conditions too. And so suddenly, they say, 'Social anxiety is all the rage. Look what we've been missing.'''8 "If anything, Paxil was worse than the other SSRIS" in terms of side effects, adds David Healy, "but the company took a very, uh, deliberate line that they were going to go after this end of the market.”9
"Every marketer's dream," Barry Brand told Advertising Age "is to find an unidentified or unknown market and develop it. That's what we were able to do with social anxiety disorder."l0 As product director for Paxil (Seroxat in Britain), the aptly named Brand had reason to crow. Although the drug he championed hit the U.S. market in I993,u quite late in the game and thus at a considerable disadvantage to its main competitors (Prozac and Zoloft), his aggressive policies soon turned it into one of a few blockbuster drugs, so named because their annual sales exceed $1 billion. In 200I alone, with 25 million new prescriptions written for the drug, Paxil's sales in the United States increased by a massive 18 percent from the year before.12 With yearly revenues exceeding $2 billion nationally, the drug had swiftly outpaced its competitors. It became America's best-selling antidepressant, with more than five thousand Americans beginning a fresh course of treatment with it every day. 13 Nor are its sales insignificant in other countries. In Japan, to consider just one other example, sales of Paxil"reached ¥I2 billion ($96,5 million) in 200I, its first full year on the market," and rose sharply in subsequent years. 14
These days Paxil racks up annual sales of $2.7 billion worldwide. 15 And while this may sound like a simple success story, it worked, as Brand admits, by pushing social anxiety disorder so aggressively that the public earned to think about mental health and unease in entirely new ways. Although the APA task forces set this process in motion, the drug companies very quick to seize the baton. Together, they turned a rare disorder into a full-blown epidemic afflicting millions, making Paxil and social anxiety disorder household names.
These strategies may seem new, but they had strong precedents. As an example, in 1961 Merck decided to market depression by buying and distribIting fifty thousand copies of Frank Ayd's study, Recognizing the Depressed Patient. The company was especially pleased that Ayd, writing for a gen~ral readership, called depression a problem afflicting more than inpatients n asylums. Merck quickly sensed a vast new market for amitriptyline, the lrst of a new class of antidepressants it patented. Through its marketing efforts it sold not only the drug, but also a more expanded idea of depresion.16
Merck's actions set a new norm for drug-company marketing. A barrage 8f excited media articles had greeted a generation of slightly earlier pills especially tranquilizers like the muscle relaxants Miltown (meprobamate) and Meprospan, the antidepressant Nardil (phenelzine), and sedatives like Librium and Valium (diazepam )-making clear that Americans in the 1950s were predisposed to pharmacology and its promised relief. In his Social History of the Minor Tranquilizers) Mickey Smith culls from the period's massmedia articles an astonishing range of euphemisms for these pills: "Wonder Drug" (Time) 1954-); "Aspirin for the Soul" (Changing Times) 1956); "Happiness Pills" (Newsweek) 1956); "Mental Laxatives" (Nation) 1956); "Don't-Give-A- Damn Pills" (Time) 1956); "Peace of Mind Drugs" (Today)s Health) 1957); and even "Turkish Bath in a Tablet" (Reader)s Digest) 1962), all the way to "Bottled Well-Being" (Time) 1980).17
While Anne Caldwell called 1950S pharmacology "the empire Psychotropia! A world power,"18 Morton Mintz was so appalled by the country's frivolous enthusiasm that he outlined in The Therapeutic Nightmare (1965) a marketing ploy that is now standard fare:
1. Public wants drug news.
2. Reporters look for drug stories.
3. Drug industry plants stories, often withholding vital facts.
4. Patient, aroused by promises of relief, pressures physician to prescribe new drug.
5. Physician accedes.19While specialist advertisements at the time struck a more sober tone, they nonetheless insisted that tranquilizing anxious patients was the best way of turning them into happy, smiling people. One revealing ad from 1960, promoting Meprospan, even gave this transformation a mini narrative, with six accompanying photographs. The first portrays a physician listening "to a tense, nervous patient discuss her emotional problems." After taking one 400-mg capsule at breakfast, however, the patient "enjoy[s] sustained tranquilization all day." The copy adds that "she stays calm" on the drug, "even under the pressure of busy, crowded supermarket shopping." Indeed, as she saunters down the supermarket aisle, selecting items for her cart, she looks like a newly minted Stepford wife. After taking another 400-mg dose in the evening, she is "relaxed, alert, attentive ... able to listen carefully to PTA proposals."
Taking 800 mg of Meprospan each day, a substantial dose, apparently causes no side effects, withdrawal symptoms, or risk of addiction. Likewise, the ad expresses no qualms about abulia-a form of emotional blunting that overmedication frequently causes. What happened, then, to the woman's "emotional problems," sketched in the first photograph? The ad implies that drug-induced tranquilization simply made them disappear.
Rather than describing such anxiety, other ads from the 1960s seem almost designed to induce it before holding out the apparent remedy. Like posters for bad B-movies, they feature frantic actresses caught in psychedelic spider webs and doctors calming overwrought housewives who torture their handkerchiefs or clutch their pearls.
The last of these has a surprisingly expansive psychological account of "depression and associated anxiety." It adds, unusually, that the drug in question works best when combined with psychotherapy or psychoanalysis. "In neurotic depressive reactions," its manufacturers advise, 'Deprol' helps relieve oppressive despondency and reduce self-hostility. Psychotherapy can then more readily guide the patient's aggressions into more normal and acceptable channels." 'While assuring readers that therapy promotes "better" functioning, the copy implies that a pill is not itself a cure for every anxious ill.
Part 3 will go into more depth about links among anxiety, aggression, and "self-hostility," but the Deprol ad is significant because it's the only one in this cluster to appear after Congress passed the 1962 advertising amendment to the Food, Drug, and Cosmetic Act. That was approved in part from serious concern that these and other ads had become too manipulative and one-sided for public and professional use. The ads cited scientific assertions out of context, oversold their effects, and, above all, gave trained and lay audiences no information about side effects, including the potentially lethal risk of overmedication.
Concern ran so high in the late 1960s and early 1970s that various Senate committees and subcommittees continued meeting to review pharmaceutical advertising. One ad causing particular concern was for Serentil (mesoridazine). Clearly trying to target outpatients and the "worried well" rather than, say, doctors treating inpatients in asylums, Sandoz marketed the pill "for the anxiety that comes from not fitting in." With the remedy carefully echoing the word serenity) Serentil's beneficiaries would thus be numerous but unexceptional: "The newcomer in town who can)t make friends. The organization man who can’t adjust to altered status within his company. The woman who can)t get along with her new daughter-in-law. The executive who can’t accept retirement."
By today's standards, the copy sounds rather tame. But in 1971, the Subcommittee on Intergovernmental Relations to Study the Safety and Effectiveness of New Drugs deemed the ad a troubling example of overreach. Since mesoridazine is a powerful phenothiazine (a chemical ingredient of numerous psychiatric drugs and pesticides), the subcommittee felt it was "inappropriate for use for the problems of everyday living."20 Already obliged to publish a correction with revised copy, Sandoz promptly withdrew the ad.
Such instances of congressional involvement in pharmaceutical advertising may shock readers used to the FDA'S current approach to these corporations. As Beth Hawkins reports, the agency in 1997 "relaxed its rules on pharmaceutical advertising to let the pharmaceutical industry bypass healthcare providers to market its wares 'direct-to-consumer' (DTC in marketing shorthand)." With what effect? "In 1996," she continues, "drug companies spent $595 million on advertising. Within a year, spending rose to $843 million. By 2000, the amount had shot up to nearly $2.5 billion. "21 Today that figure is considerably higher. Health journalists Ray Moynihan and Alan Cassels put the total for all drug-related marketing at $25 billion, with $3 billion spent annually on direct-to-consumer advertising alone.22 That's almost $10 million a day.
The same companies also effectively sponsor the FDA on a pay-for-play basis, which gives them a cozy relationship with those overseeing their products. Government watchdogs call this "capture": The regulatory agency ends up so close to the industry monitored that it ends up toothless. As David Healy warns of the FDA, "The regulators ... depend for advice on experts who increasingly claim independence on the basis that they have consultancies with all the [drug] companies. "23 A spring 2006 report in the Washington Post underscored that every expert working on the DSM criteria for depression and schizophrenia had financial ties to the pharmaceutical industry, and more than half of those working on the remaining disorders had similarly compromising ties.24 So while American psychiatry has developed an almost insurmountable conflict of interest with the drug companies, the FDA, a small, overworked agency, has grown so close to the latter that it has become lax about granting fresh licenses for existing drugs.25
Congressional attention certainly didn't resolve this problem in the 1970s, but it had a swift effect on the drug industry's cavalier ads. By the time the Warner company pitched the following for Nardil three years later, its marketing department alternated hyperbole with a reasonably full account of the drug's clinical and medical effects. "This man is an island," it declares, altering Donne's most famous line to portray the anxious solitude of a man wringing his hands. "He is a phobic patient, living alone with his fear and anxiety. Nardil, a proven MAO [monoamine oxidase’ inhibitor, will help bring him back to the mainland of society. "26
The obvious message here-massively intensified in later ads-is that groups vanquish loneliness, while solitude is intrinsically troubling. A recluse or misanthrope would doubtless invert such claims, representing solitude as a much-needed reprieve from the competition, malice, and bigotry that groups often incite. But when loners seem intrinsically to be suffering from psychiatric disorders (in this case, avoidant personality disorder, later formalized by DSM-III), their perspectives become harder to trust. If they are already mentally ill in the eyes of psychiatrists, then sadly we are less likely to heed their words and more inclined to side with the experts in saying they need help.
As the examples make clear, the drug companies represent depression and anxiety with shrewd attention to our weaknesses and concerns. So while mental illness is not a fabrication (a claim that in this context is worth underlining),27 the way marketing and other venues define illness greatly influences how our culture and mass media gauge its impact and severity. With visual and rhetorical cues both crude and subtle, the ads also make clear that our models of illness-like our cultural aspirations-have changed dramatically over time.
These days we're more likely to want emotional and professional balance on our own terms than to fret so blatantly about fitting in.28 So even post-I999 ads for social anxiety disorder, which psychiatrists view as closest to manifesting acute concern about peer evaluation, tend to frame such concerns with this desire for balance in mind. Like so many other Paxil ads, attractive models visually underscore the desired outcome-"balance," happiness, and self-confidence. They
downplay the experienced or merely feared source of difficulty, which the ads describe marginally, in tiny print, at the bottom of each page. In ways that counteract Warner's marketing strategy for its 1973 Nardil ad, these Slovakian, Arabic, and North American ads for Paxil play up virile strength, effortless exuberance ("It's me"), and rapturous sociability ("Your life is waiting"). "Come join us" or envy us, the figures invite and cajole. Ending social anxiety seems to be a lifestyle choice after all.
The variables of marketing-like the models of disease they portray-obviously change, but the fundamentals of identifying, or generating, audiences for one's product are more constant. The story of how SmithKline Beechman (now GlaxoSmithKline, after a merger with Glaxo Wellcome in 2000. 29 marketed paroxetine for social anxiety disorder fits this pattern so closely that it is strikingly predictable: First push the disease, then promote the drug that will treat or cure it. Still, the story of Paxil's success could easily have taken a quite different turn.When SmithKline finished developing the drug, it faced a number of hurdles. For one thing, Eli Lilly's Prozac had been around since 1987, attracting phenomenal media coverage, patient loyalty, and doctor support. Pfizer too had beaten SmithKline to the punch, releasing Zoloft in 1992 and touting it as a milder alternative to Prozac. Paxil risked appearing as merely a me- too variant of the new class of antidepressants soon known as "selective serotonin-reuptake inhibitors," or SSRIS, in a market fast reaching saturation. So SmithKline did what any corporation with deep pockets would do. It hired an exclusive Madison Avenue public relations firm, Cohn and Wolfe, a company with expertise in handling pharmaceutical products. Together they launched an aggressive marketing campaign to create a new market for its product.
Just one of the many challenges facing Cohn and Wolfe, as an internal memo explained, was "generating excitement about a drug that was introduced seven years ago."30 Another was that Paxil, first developed back in the 1970s, had a spotty record and at the outset produced troubling side effects-chiefly dependency issues and withdrawal symptoms-within a very short period of time. 31 Further, the earliest clinical trials for paroxetine made painfully clear that the drug was actually less effective than older antidepressants, a point the Danish University Antidepressant Group soon confirmed in a large study. 32 SmithKline was so unimpressed by the drug's potential that it considered shelving paroxetine. 33
Given the high stakes for public health, it is remarkable that these and other cautionary findings got only a fraction of the airtime they deserved. In 2002, moreover, rigorous studies reviewed the same figures the drug companies had presented to the FDA to secure approval for the drugs, and found that Paxil, Prozac, Zoloft, and other SSRIS show negligible improvement over placebos (sugar pillS).34 With results so poor, the researchers concluded that these drugs should never have been approved to treat depression or anxiety.
Studies appearing since confirm these doubts, signaling that as many as 25 percent of patients taking Paxil experience severe problems when trying to end treatment. Far greater numbers suffer nasty side effects during treatment, with many researchers putting the figure for those experiencing sexual side effects like loss of libido and anorgasmia from any SSRI at a staggering 70 percent.35 Even so, these effects may be the least of the concerns: we must now add much more severe problems like renal failure, susceptibility to strokes and coma, blood clotting, pregnancy complications (including serious birth defects), and increased risk of self-mutilation and suicide. 36
In the case of Paxil/Seroxat, these risks were dramatic enough to prompt inquiries on both sides of the Atlantic, including a belated, full scale FDA review in this country, a battle in the courts over whether the drug was habit forming (a battle in which, unusually, the FDA decided to get involved, thereby compromising the separation of powers), and an investigation on Britain's current affairs program Panorama, to which the public responded with a flood of concerned calls and emails.37
"When the British regulators got to see all these studies in June 2003," Healy reports, "they concluded that, combined, they pointed to a I. 5 to 3.2 times greater risk of suicidality on Paxil than on placebo."38 In the spring of 2004 The Lancet, the prestigious British medical journal, published an article with clinical test data revealing problems with prescribing Paxil and other SSRIs to children. (The Lancet later named this article the scientific paper of the year.) 39 After several well-publicized lawsuits, SmithKline was forced to add a black-box health warning about the risk of prescribing the drug,40 though just a few weeks later it was caught distributing memos advising its sales representatives not to discuss the suicide related risk of Paxil/Seroxat with doctors.41
Worse still, there is no doubt the company knew about these problems right at the start-that is, "long before Paxil came to the market."42 Its first press release for Paxil called the drug "safe and well-tolerated," touting the results of three studies allegedly proving it was "significantly more effective than placebo in treating social anxiety disorder." (How SmithKline defines "significantly" remains anyone's guess.) Other key statements trumpet largely meaningless pronouncements, including that "69 percent of patients treated with Paxil (20 to 50 mg daily) responded to treatment (compared to only 29 percent of patients given placebo) at week 12. "43 Although the company invites us to assume that those responses were positive, the nature and quality of the responses are not specified. The company also neglects to mention how many patients participated in the trial and how many dropped out because they had already begun experiencing side effects. Its own archives indicate, however, that dependency and withdrawal issues began affecting participants after just a few weeks.44As these companies still are not required to publish findings that do not support their interests-even, remarkably, for the FDA-one has to calculate them by a process of elimination, in this case the alarmingly high3I percentage of patients that goes unreported: almost three in ten participants. The pharmaceutical industry is notorious for recasting severe problems like suicide ideation as "emotional lability" (mild-to-notable mood swings), which makes a drug's side effects seem less worrying and dangerous.45 Finally, the FDA assesses this information purely on a comparative basis with placebo. This standard for judging efficacy is substantially lower than gauging whether the drug outperforms existing treatments. Nor is the FDA immune to conflicts of interest. "During a later consideration ofPaxil," writes Healy, "[Tom] Laughren of the FDA denied detailed knowledge of the significance of a healthy volunteer study on Paxil showing problematic side effects, on the basis that he had inherited this file from Martin Brecher," a previous consultant at the FDA who had left to work directly for two pharmaceutical companies, first Janssen then AstraZeneca.46
How does SmithKline view these concerns? A classified report from 1998, with a foreword by Paul N. Jenner, director and vice president of neuro- science and worldwide strategic product development, gives us a crucial window into its thinking and actions. The year before Paxil received FDA approval, the company decided to use "highly skilled sales and marketing efforts" to tilt the issues. Its efforts included "managing the discontinuation" problem by touting negligible clinical results and minimizing well-documented side effects and withdrawal symptoms.47 Stress the drug's "flexibility and control," the report advised, and spin the problem of "sexual dysfunction" by "putting the issue in context. "48 SmithKline also zealously controlled its own terminology and company rhetoric: "Highlight the benign nature of discontinuation symptoms, rather than quibble about their incidence."49 Even so, "terminology such as 'withdrawal symptoms' should be avoided," the authors advised, "as it implies dependence. "50
Given the seriousness of these side effects, it's shocking to see how aggressively the company dismissed the "flaws and failings" and "three main attacking points" of one of its main rivals, in ways that painfully reveal SmithKline's own hand: "Lilly has created these instruments to suit its own purposes," the report avers. "It is impossible to draw any meaningful conclusions from the[ir] study."51 The writers then ridicule the policy of their competitors, who clearly play by the same rulebook: "a commercial smokescreen by Lilly" and "clearly a marketing ploy ... and a sign of desperation in the fight for market share."52
Regarding when patients should end treatment, SmithKline's memo privately concedes: "The issue' ... has been almost entirely driven by marketing and is often based on misinterpreted or carefully selected data. "53 That might be news to pregnant mothers who had been assured it was safe to continue taking the drug into their final trimester, or to patients with kidney and blood-clotting problems whose doctors prescribed the drug to quell their anxiety.
Yet because DSM-III had so dramatically expanded the pharmaceutical market for anxiety disorders, SmithKline's executives enthused, "The opportunity ... is enormous-around 90 million adults in North America and Europe are affected at anyone time." Despite the drug's poor showing in clinical trials, the company sought to "add new anxiety disorders (e.g., social anxiety disorder/social phobia, GAD, PTSD) to the label which reinforce [its] positioning as first choice antidepressant for depression and depression with anxiety," the better "to own the ... market segment."54
In March 1999 SmithKline Beecham received the first FDA license to treat social anxiety disorder. As things could have taken a quite different course, it's worth keeping that alternative scenario in mind as we assess how the drug was advertised and promoted.Keenly aware of Prozac's skyrocketing sales, the robust demand for antidepressants, and the newly expanded market for anxiety disorders, SmithKline neither abandoned Paxil nor sought to account for its poor results. In a move of either bravado or cynicism, it called the drug "safe and well-tolerated" on the basis of a few limited results it was prepared to publish at the time. By going on the offensive, moreover, the company pushed the idea that the drug was the only selective serotonin - reuptake inhibitor, 55 calling it "Paxil CR" (for "controlled release" at the neuronal level), as if it targeted the brain's receptor cells more intelligently than either Prozac or Zoloft. The results in fact suggested nothing of the sort. 56
Owing in part to existing fears that Prozac blanketed these cells indiscriminately, SmithKline's strategy paid off. Deciding not to present Paxil entirely as an antidepressant, the company used Cohn and Wolfe to style the drug mostly as an anxiolytic, or remedy for anxiety, and later still as a panacea for acute shyness. Although this strategy logically undermined the idea that Paxil was a selective drug (SmithKline was soon targeting it for "a spectrum of" problems-including generalized anxiety, panic, major depression, obsessive compulsive, and premenstrual dysphoric disorders), Cohn and Wolfe were such experts at pitching and recasting healthcare products that few noticed or seemed to mind the startling discrepancy.
"We're not only tapped into the latest trends," Cohn and Wolfe promotional literature boasts; "we set them. "57 With a list of clients including Taco Bell, Hilton Hotels, Visa, and many household brands, the statement is no idle boast. Indeed, by its own admission, the firm's healthcare division does a lot more than market drugs; by hyping modest results as breakthroughs and "managing crises" by burying equivocal and negative results, it also knows how to influence the FDA, EMEA (European Medicines Agency), and other regulatory bodies. "But it is often the work we do cultivating the marketplace prior to approval," the company asserts, "that demonstrates the true power of our communication efforts. "58 Social anxiety disorder was, and remains, a fascinating case in point.
Soon after the FDA gave SmithKline a green light to treat social anxiety, Cohn and Wolfe couched the first stages of its campaign as a generous bid to raise public awareness about the disease. The initial goal, as PR News helpfully broadcast, was less to promote Paxil than "to educate reporters, consumers, and, in some cases, physicians, in an effort to encourage diagnosis and treatment. "59 The 1998 memo from SmithKline, quoted earlier, was even blunter: The company needed to reeducate the public about its notions of mental illness and health, as "patients with social anxiety disorder often share the common public misperception that what they experience is severe shyness."6o Nothing less than a total transformation in the perception of shyness would do. The title of at least one media article caught the drift: "You're Not Shy, You're Sick."61
As an opening stratagem, then, Cohn and Wolfe plastered bus shelters across the nation with posters featuring the eye-catching slogan, "Imagine Being Allergic to People." Accompanying this clever headline was a picture of an attractive yet forlorn man staring morosely into a teacup. "You blush, sweat, shake-even find it hard to breathe," the man seems to say. "That's what social anxiety disorder feels like."
One might wonder whether people suffering from an acute problem would need a PR company telling them what they or their loved ones are feeling. At whom, then, was the "awareness campaign" really aimed? The already afflicted, whom Cohn and Wolfe hoped would view their distress in a more severe light? Or the healthy but worried, who could be persuaded that run-of-the-mill concerns like public-speaking fears or reluctance to eat alone in public preceded something far more serious-a "crippling" mental illness now given an impressive new acronym?62 Both constituencies were told that while their anxieties had psychological effects, a serotonin deficiency in their brains was most likely responsible. As one 2001 advertisement declared: "Paxil works to correct the chemical imbalance believed to cause the disorder Most people who experience side effects on Paxil are not bothered enough to stop taking Paxil. ... Talk to your doctor about non-habit-forming Paxil today."63
Once you begin talking about a deficiency or imbalance in anything to do with health, Moynihan and Cassels note astutely, the need to correct the problem becomes more than legitimate; it is also an obligation. Indeed, those failing to "take an active interest in their health," whether by seeking remedies or simply by "knowing their figures" for such matters as cholesterol, begin to seem too ill or lacking in self-respect to care about themselves.64 Ingeniously, then, the diagnostic cycle begins to repeat itself without the aid of marketing. Ask for information if you're worried; not doing so may mean you're too unwell to grasp the full extent of your problems, in which case worried friends and relatives should rush you to the nearest doctor, psychiatrist, or emergency room.
By equating social anxiety with an allergy to other people, Cohn and Wolfe had greatly embellished what even their most loyal consultants were prepared to affirm. Yet such tactics pale beside those used to mask the campaign’s sponsors and financial beneficiaries. For the posters made no reference to Paxil or SmithKline. They referred only to a group called the Anxiety Disorders Association of America, whose two other nonprofit members include the American Psychiatric Association and Freedom From Fear (FFF). Anyone seeing the posters would assume this "coalition" was a grass-roots alliance of independent agencies, developed in turn by patients wanting remedies for their suffering. Remedies that might include, but needn't be limited to, medications.
Not so. Until recently, Cohn and Wolfe handled all the group's media inquiries. FFF, several investigative reporters discovered, was an advocacy group that SmithKline quietly sponsored and financed behind the scenes.65
These tactics didn't seem to trouble the drug company or its shareholders. Wall Street shrewdly predicted a huge new market to combat shyness, and SmithKline Beecham, earning impressive sales shortly after FDA approval, saw steep rises in its share price. Cohn and Wolfe also had reason to brag: its "prelaunch initiative" ensured that 96 percent of media coverage delivered the key message, "Paxil is the first and only FDA-approved medication for the treatment of social anxiety disorder. "66
Many smaller newspapers ran the company's press releases unedited. Indeed, Cohn and Wolfe's aggressive campaign was so successful that it not only generated "1.l billion media impressions" in the first crucial year of FDA approval (400 million in the first month alone), but also won it an award from the Public Relations Society of America. The prize givers were especially pleased to see "public awareness of SAD and other disorders" raised so diligently. 67
With its awareness campaign under way, Cohn and Wolfe could turn to building a constituency of patients who would present themselves for medication. To this end, it had several strategies up its sleeve, as its own memo made clear:
· Educate the public via interviews with patients, physicians, and third party groups.
· Avoid positioning Paxil as a "lifestyle drug," but [rather] as a safe and effective treatment for a severe, debilitating medical condition.
· Raise awareness [of] other indications for Paxil, while focusing on Social Anxiety Disorder.The company's "action plan" comprised three more bullet points, with the first doubtless garnering the verdict, "mission accomplished":
· Partner with Social Anxiety Disorder Coalition to generate credibility for "severe, debilitating condition" message.
· Work through Coalition and physicians to identifY patients to speak in telephone press briefing, satellite media tour, and online chats.
· Conduct aggressive media outreach with VNR/b-roll [Video News Release/ documentary-style footage], press kit, graphics, radio news release, mat release [ready-made news story], and spokesperson network.68In surveying this sequence of objectives and strategies, with its "aggressive ... outreach" briefings and fervent bid "to generate credibility," one could be forgiven for thinking it resembled the outline of a military campaign. Certainly, it cost almost as much as one.
True to its word, the firm distributed "video news releases" nationwide to television stations, whose wide-eyed health reports dutifully declared that the shy and reclusive might be suffering from a "severe, debilitating condition." SmithKline also spent $30 million for an onslaught of even more television and media ads, featuring attractive, self-assured models often, though not exclusively, female-who affirmed with perfect smiles that they had regained their emotional (and, presumably, neurochemical) "balance." One woman beams: "I can see my future ... I can taste success ... I can feel peace ... I can touch my life." Insisting Paxil has "proven efficacy that spans a spectrum of disorders," Cohn and Wolfe gave the ads memorable tag lines. In addition to the expectant ("Your life is waiting"), it offered the winningly affirmative ("I can") and the hopelessly corny ("Hello, my name is ... me").
Although Cohn and Wolfe strove to portray Paxil as "a safe and effective treatment for a severe, debilitating medical condition," its second wave of
ads needed to appeal to such a vast constituency that the company quickly blurred the line between acute anxiety and common unhappiness.69 Not surprisingly, then, the ads give the impression that this "debilitating ... condition" was really about lifestyle choices and "balance" (a recurring word, but a shifting ideal). For instance, "Julie, outdoor enthusiast," betrays no hint of anxiety from her rural idyll; she radiates confidence as she smiles directly at the viewer from just outside her tent. "Start her on something she can stay with," the copy exhorts, something that will help likeminded patients (who surface in related ads as grinning outdoorsy types in soft focus and want "living without interruptions," including presumably those from drug-related side effects).When Cohn and Wolfe included men in its marketing campaign, it tended to represent them in working environments, where Paxil might help them gain optimum job performance. They are depicted either clinching an important deal ("Paxil: Show them they can") or, just as emotionally charged, lamenting that they had failed to do so. One such ad from 1999 depicts a young businessman in three stages of office-related despair and shame. Backlit, as if by an invisible sun, are the following words in bold: ((Show them they can. Paxil-Paroxetine Rel. Relieve the anxiety. Reveal the person."
The PR firm also needed media stories to create buzz about the disorder."Are you or someone you know suffering from symptoms of social anxiety disorder ... ?" one of countless near-identical articles asked readers, in a Spotlight on Health. "If so, you are among the estimated 10 million Americans who have this debilitating disorder." Reproducing almost verbatim SmithKline's own press release and the upper ceiling of Stein's inconclusive phone survey, this article (and others) spread rapidly on the web and in a multitude of printed venues. According to the anonymous author, "An awareness campaign about social anxiety disorder conducted over the last two years has motivated people to seek professional help or, at the very least, made them feel less alone, according to a survey of callers to a toll free phone line sponsored as part of the campaign by a group of patient and professional mental health organizations."
We already know who constituted these organizations and how they funded the campaign. The article then quotes Mary Guardino, executive director of Freedom From Fear, saying: "It is very gratifying to learn that people who saw the campaign and called to receive more information felt it improved their understanding of this disabling condition, and were prompted to seek professional support." The survey asserts:
· Two out of three (6r%) of those surveyed [960 callers] said they had heard about social anxiety disorder compared with 38% who said they had not.
· Four in five (8 r%) said they found the social anxiety disorder campaign made them feel they were not alone in suffering social anxiety disorder symptoms.
· Three out of four (78%) said the campaign improved their understanding of social anxiety disorder; a similar number (75%) said it helped them identify what they were feeling.
· Three in five ( 60%) said it motivated them to seek additional information about the disorder and ++% said it motivated them to seek professional help.70The more one rereads these claims, the less they really say. As direct-toconsumer (DTC) pharmaceutical marketing regularly exhorts viewers and readers to "ask their doctor about" one of a multitude of products, the final results are not especially surprising. Further, as SmithKline not only paid for this massive awareness campaign but also funded the organization earmarked to analyze its results, we must take all such percentages with a rather large pinch of salt.
Highlighting as much as anything that life in contemporary America can be profoundly lonely and isolating, the percentages do, however, confirm the relief that can result from giving suffering a scientific name or acronym. This support may be especially consoling when it implies a biological or genetic condition for which the patient is not to blame. Hence, in part, the success of the National Mental Health Awareness Campaign's posters: "It's not your fault."71Cohn and Wolfe's "aggressive media outreach" with "spokesperson network[ s]" required finding suitable celebrities and photogenic members of advocacy groups like FFF to put a face on the disease. In so doing, the firm gained valuable airtime without appearing to pitch a product and, best of all, without needing to balance the picture by enumerating Paxil's litany of harmful side effects. As the stories-seemingly spontaneous would stress recovery from the ordeal of shyness, they would uphold and naturalize the disorder. By generating comparisons ("I've felt that, too"), such stories would win the recovering patients or celebrities so much sympathy and publicity that anyone doubting the magnitude of their suffering (that is, anyone mentioning what they were being paid to describe it) would seem heartless, uninformed, or both.
Public relations companies know that celebrities are especially useful in raising awareness of a medical or psychiatric problem, because they wield "an intangible sort of magic" for the public, which can greatly increase publicity and sales.72 Already figures of admiration and trust, they diminish any remaining stigma attached to such problems. So, as before, these stories and ads repeatedly underscored a link between the condition and the drug.73
Indeed, this loop became so patent that when Ricky Williams, running back for the Miami Dolphins, announced to Oprah and several million of her viewers that he suffered from crippling shyness, he added rather sheepishly that he had recognized his condition only after watching a TV commercial about the disorder. Such a statement seems almost surreal when one considers that SmithKline, already spending a cool $30 million on these ads, paid Williams an undisclosed sum for his statement, too. Yet these moments of sponsored reverse affirmation-by celebrities, patients, and even paid consultants-epitomize social phobia's history as a clinical category. "I've always been a shy person," Williams declared, a statement dutifully repeated by the New York Times, the Los Angeles Times, and other media.74 Apparently he was shy only about revealing that he'd been hired to raise public awareness about social anxiety disorder.
"No therapeutic category is more accepting of condition branding than the field of anxiety and depression," states Vince Parry, an industry insider. One reason, he says, is that mental "illness is rarely based on measurable physical symptoms and, therefore, [is] open to conceptual definition. "75 Neuropsychiatrists and pharmacologists, like those serving on the DSM task forces, would doubtless disagree, insisting their diagnostic criteria derive from hard facts and science. But the marketing of illness and its scientific foundations-already a precarious union-finally came apart in the 1990S, and since then the gap has only widened.
One learns a lot when insiders share their best tips with fellow marketers.According to Parry, "There are three principal strategies for fostering the creation of a condition and aligning it with a product:
· elevating the importance of an existing condition;
· redefining an existing condition to reduce a stigma;
· developing a new condition to build recognition for an unmet market need.”76Based on what we've seen, this advice is eerily familiar. The list of fake or exaggerated conditions for which medical remedies have been launched is dismayingly long. So too, of course, is the history of quacks and swindlers conning the public with bogus antidotes for largely imaginary ailments. It's one thing when these misunderstandings stem from gossip, with merely local effects; it's quite another when the disease mongering is systematic and recurring on a massive scale, orchestrated by expensive marketing campaigns whose truth and legality often rest on the parsing of a single adjective or verb.
One of the easiest ways to overstate the gravity of a medical condition, Parry finds, is to dazzle patients with acronyms. He cites Pfizer's Viagra for ED (erectile dysfunction) and SmithKline's Zantac for GERD (gastroesophageal reflux disease). In the case of GERD, the public previously assumed that over-the-counter remedies would be adequate in tackling heartburn, so a barrage ofpR and advertising had to convince them otherwise. Almost identical strategies were devised to promote IBS (irritable bowel syndrome), ADHD (attention deficit hyperactivity disorder), PMDD (premenstrual dysphoric disorder), and a host of other doubtful terms and conditions the drug companies have spent millions trying to press into our daily vocabulary.77
SmithKline's "Social Phobia Inventory," a "reliable tool" for doctors and patients, abbreviates to "SPIN." Apparently unaware of this pun, the company adds: "SPIN is a well-tested ... screen ... for the symptoms of social anxiety disorder and thereby assists patients and doctors in identifYing the disorder." Like many other self-administered quizzes, the test is extremely open -ended, urging potential customers to respond, on a scale of I to 4-, to statements that seem far from typifying an acute psychiatric disorder:
· Being criticized scares me a lot .
· I avoid going to parties.
· Talking to strangers scares me .
· I avoid speaking to anyone in authority.
· Trembling or shaking in front of others is distressing to me.78The drug companies don't create these guidelines in isolation. They borrow heavily from specialists in anxiety disorders, like John R. Marshall, whose aptly subtitled book Social Phobia: From Shyness to Stage Fright ("New Help for Millions of Sufferers") similarly emphasizes public speaking, dealing with authority figures, social gatherings, and other forms of largely job-related embarrassment. Although he warns, "There is no absolute score that indicates social phobia," he does concede, open-endedly, "Patients in a treatment study for social phobia had pretreatment scores on this scale ranging from 19 to 56."79
When Michelle Cottle, a journalist at the New Republic) encountered Marshall's quizzes, she thought them so ludicrous that she decided to conduct a unscientific poll of her own: "I asked some of my coworkers at TNR to take a short diagnostic test developed by" Marshall. "Of the 23 ... staffers to complete the survey (the rest were presumably too timid)," Cottle adds wryly, "a sizeable majority scored above 19. Based on these results, I've recommended that the magazine's benefits manager explore the possibility of getting a group discount on Paxil. "80
The vagueness of these quizzes and their associated criteria might well invite disbelief and jocularity, but a huge number of self-help manuals take them very seriously, as do the many advocacy groups and organizations that sprang up after DSM-III appeared (doubtless because their rationale and business partly depend on them). At the Shyness Institute, founded in 1994- by two psychology professors at Stanford University, research focuses on "improving treatment methods for shyness and social anxiety disorder / social phobia," as well as "the role of affect/emotion in the phenomenon."81 There's a similar "Shyness Research Institute" at Indiana University Southeast, and the "Public Speaking-Social Anxiety Center of New York" offers a range of workshops "for the chutzpah-challenged. "82
Comparable classes at Manhattan's Learning Annex range in their topics from "Are You Shy? Is It Holding You Back?" to "Dating Strategies for Shy New York Singles. "83 Meanwhile, the Adult Anxiety Clinic at Temple University straddles the practical and theoretical sides of this divide. Its director, Richard Heimberg, grew interested in the issue after studying 75 college men with dating anxiety.84 Must one really inflate such fears into disorders, however, to give them credibility?
While many universities are lending a hand to formalize the study of social anxiety and shyness, the drug companies frequently sponsor patient support and advocacy groups behind the scenes-as we saw when SmithKline funded Freedom From Fear to generate sales, buzz, and legitimacy for Paxil. Moynihan and Cassels report in Selling Sickness: "A global survey from Britain estimated that two-thirds of all patient advocacy groups and health charities now rely on funding from drug companies or device manufacturers. The most prolific, according to the survey results, is Johnson and Johnson and number two is Pfizer. While creating the appearance of corporate generosity, such sponsorship can bring many benefits to the sponsor as well as the recipient. Chief among them is that patient groups are a way to help shape public opinion about the conditions [the] products are designed to treat. "85
The corporations adopting these practices have not suddenly become charities. The costs of funding these groups (like the costs of "free" samples and giveaways to doctors and psychiatrists) always return to the patient, whether as price hikes or as raised co-payments to healthcare providers. When challenged about these policies, the companies insist they are doing a public service by raising awareness of a hidden or underreported problem-a position many psychiatrists (also on the companies' payroll) are happy to endorse.
Support groups don't of course represent all patients, many of whom endure chronic symptoms-some exacerbated by the drugs themselves, as we'll soon see. Although these groups put a face on each illness and often challenge those questioning its legitimacy, they rarely disclose their funding. Nor do they volunteer that firms like Cohn and Wolfe handpick the patients for media appearances, based on their looks, then coach them to hone the clarity and force of their message. One of these messages, SmithKline's 1998 memo affirmed, is that "patients with social anxiety disorder often share [a] common public misperception that what they experience is extreme shyness. "86
As we piece together this complex puzzle, the overall picture becomes disturbingly clear. By giving "social phobia" the more patient-friendly name "social anxiety" and by greatly expanding its parameters, the DSM task forces significantly lowered the bar for the FDA and drug manufacturers. Euphoric about their massive new markets, which they rushed to cultivate with "carefully selected data," the drug makers then fudged key distinctions between routine fears and chronic disorders to make them seem identical.
When Pfizer tried to capture part of the shyness market in 2003 for its antidepressant Zoloft, for instance, it ran an ingenious campaign asking simply of a beautiful woman with downcast eyes, "Is she just shy? Or is it Social Anxiety Disorder?" Except for their content, the questions might be part of an ad campaign for cosmetics, Memorex, or a pricey shampoo.
Such banality is the point. The phrase social anxiety disorder was so commonplace by 2003 that this last ad didn't bother to gloss it. Apparently, the public no longer needed to know it was suffering in vast numbers from a "debilitating medical condition." The PR firms and marketing departments, bludgeoning us repeatedly with this constant refrain, had already done their job.
As mentioned in P.1, this extensive investigation grew out of our innitial discovery of some discrepancies in DSM-IV. See also written paralell to the former our extensive case study about: Dissociative identity disorder, formerly known as multiple personality disorder (MPD).
Conclusion
It would be naive to think, the wrangles we've observed in psychiatry had no effect on the wider culture. So for example in the New York Times on Sept.9, 2001; "Psychotropic drugs and their supposedly problematic effects on human autonomy and identity," writes David Gates "is a topic as old as Brave New World and as new as Peter D. Kramer's Listening to Prozac-which is no longer all that new."
Earlier that same year, Erwin and Heimberg in turn wrote, "Despite the demonstrated efficacy of CBGT [cognitive-behavioral group therapy] and other cognitive behavioral techniques for social anxiety disorder, some patients do not achieve clinically significant improvement by the end of treatment." Rather than question the reason for this outcome and thus the validity of their approach, including its reliance on DSM categories, they insist, "There is a strong need to determine who will and will not complete or respond to cognitive-behavioral treatments for social anxiety disorder." ("Duration of Treatment and Depression Relapse and Recurrence Rates," a confidential February 200I memo prepared for GlaxoSmithKline by CMAT-Neurosciences, page 2.)
And what work on the next manual concerns, while it is unlikely to scale back on the seven anxiety disorders in DSM-IV, several other conditions are almost certain to make the final cut for the fifth edition: compulsive buying disorder, Internet addiction, binge-eating disorder, compulsive sexual behavior disorder.
The April 2005 issue of NeuroPsychiatry Reviews debated whether the next edition of DSM should include criteria for a new psychiatric problem: apathy. According to James Duffy, a tenured professor at the University of Connecticut, apathy isn't just a state of mind; it's a "common" illness that "can occur alone and in conjunction with other disorders, [and] in percentages that translate into millions of people." The clincher for apathy's inclusion in the manual of mental disorders, he says, is that "psychotropics are a very potent cause of" it. (Michelle Stephenson, "Should Apathy Be Included in the DSM-V?" NeuroPsychiatry Reviews 6.3, April 2005).
And road rage, mentioned in DMV-III where it is called intermittent explosive disorder (IED), received additional attention after Ronald Kessler and his team at Harvard announced that in the US alone, 16 million Americans may be suffering from it. "Although the majority of people with IED (60.3%) obtained professional treatment for emotional or substance problems at some time in their life," Kessler and his colleagues stated, "only 28.8% ever received treatment for their anger." (Ronald C. Kessler et al., "The Prevalence and Correlates of DSM-IV Intermittent Explosive Disorder in the National Comorbidity SurveyReplication," Archives of General Psychiatry 63, June 2006, 669-78).
Plus then there are examples like The Antisocial Behaviour Orders (ASBOS), which came into effect in Britain in 1999, generated widespread debate in Britain, not least because they rely on implicit norms that are profoundly conservative and conformist. Ranging from a minimum of two years to no upper ceiling, the orders are civil not criminal sanctions, though they can result in prison sentences. (See also www.crimereduction.gov.uk.) Articles that voiced their concern about the misuse of ASBOS is Sarah Lyall, "Britain Cracks Down on Nasties Like the 'Neighbor from Hell,'" New York Times (April 2, 2004-); Michael White, "Blair Admits ASBOS Have Yet to Beat the Louts: Prime Minister Says Crackdown on Hooligans Has Still to Reach 'Critical Mass,'" The Guardian (September I, 2004-); and Martin Bright, "Residents Delight as Anti -Social Teenagers Are Named and Shamed," The Observer (October 12, 2003). Dolan Cummings, in; "Don't Conform, Break the Rules: Observations on Antisocial Behaviour," New Statesman (September 27, 2004-), 16-18, concludes: "The problem ... is not so much rampant individualism as shrinking-violetism. New laws, rules, and regulations simply reinforce the public's passivity.
In a different context, and more specifically pointing at issues in DSM-IV, Arthur Kleinman (Harvard professor of psychiatry and medical anthropology) warned for a trivializations. In this case;"Kleinman fears that including mild forms of anxiety and depression under an ever-widening umbrella of mental disorders will divert attention and resources from diseases like schizophrenia and major depression, which remain undertreated and stigmatized across much of the world. In his view, "We may turn off the public, who are a huge source of support for mental-health research, by telling them that half of them are mad." (Ashley Pettus, "Psychiatry by Prescription: Do Psychotropic Drugs Blur the Boundaries between Illness and Health?" Harvard Magazine, July-August 2006, 38-40.)
Donald C. Kessler dismissed These concerns as the "false enthusiasm of the noncombatant," by which he meant, according to the writer, "If you haven't worked directly with people who suffer from so-called mild disorders, it's easy to write them off as ordinary." Yet Kleinman's hands-on experience includes developing mental-health policy and programs with the World Health Organization, as well as detailed clinical and cross-cultural knowledge of schizophrenia.
Part of this is however about the ethics of diagnosis and treatment. Whereas skeptics fear that things have gotten out of hand, and “mild disorders” should be eliminated from the DSM-V" people like Kessler face these doubts from the other direction and want to keep psychiatric diagnoses as elastic as possible. A key concern of Kessler and his group argue that if DSM-V were to raise the bar and set the threshold for inclusion higher, millions of patients would no longer be defined as ill.
Nor would Kessler's team be able to state, as they currently do that about half of the people will meet the criteria for a DSM-IV disorder sometime in their life. 18 If the criteria for every disorder were appropriately tightened, not relaxed, the upper range of each would plummet. The number of people seemingly afflicted by mental disorders would nosedive Or as Kutchins and Kirk's wrote in reference to this: "By simply altering slightly the wording of a criterion, the duration for which a symptom must be experienced in order to satisfy a criterion, or the number of criteria used to establish a diagnosis, the prevalence rates in the United States will rise and fall as erratically as the stock market." (Herb Kutchins and Stuart A. Kirk, Making Us Crazy: DSM: The Psychiatric Bible and the Creation of Mental Disorders, New York: Free Press, 1997, 244.)
For one however the history of medicine and of psychiatry had many cases (thalidomide and leukotomy, to name only two) where experts proceeded on well-meaning assumptions that hindsight and fuller research proved to be dreadfully misplaced. Second, because psychiatrists often downplay the role of consciousness in mental illness, they tend to reject it out of hand and, in so doing, fall back on facile explanations for cause and effect. These tell us nothing about the way the mind facilitates, blocks, or distorts social forces and biological stimuli. Broader philosophical arguments about the mind-developed and finessed across millennia thereby are shunted aside as inconsequential.
And at least one, of no doubt several conclusions, points to the importance of ‘how’ a professional uses the current DSM-IV and more importantly how much experience the person in question has with knowing; what works and what doesn’t-- where and when.
1."Social Phobia," DSM-IIIR (300.23),241.
2. Although this rejection intensified in the 199os, it began much earlier, with psychiatrists such as Martin Fleischman lamenting his own profession's "quasi-religious revulsion against the pill" (by which he meant all pharmacology), and Gerald Klerman two years later decrying what he called "Pharmacological Calvinism" (by which he meant "if a drug makes you feel good it must be bad"). See Martin Fleishman, "Will the Real Third Revolution Please Stand Up?" American Journal of Psychiatry 124.9 (1968), 1262; and Gerald L. Klerman, "Drugs and Social Values," International Journal of the Addictions 5.2 (1970), 316.
3. Murray B. Stein, John R. Walker, and David R Forde, "Setting Diagnostic Thresholds for Social Phobia: Considerations from a Community Survey of Social Anxiety," American Journal of Psychiatry 151.3 (1994), 408.
4. "Patient Testimonials Reintroduce an Old Drug in a New Market," PR News 56.20 (May 15,2000),1.
5. SmithKline Beecham press release, "First Medication for the Treatment of Social Anxiety Disorder Approved by the FDA: SmithKline Beecham's Paxil® to Treat Highly Debilitating Condition" (May II, 1999), I. Obtained from Cohn and Wolfe, SKB's public relations company.
6. SmithKline Beecham PLC, "Seroxat/Paxil Fact File" (Abingdon, Oxfordshire: The Medicine Group [Education], 1998), see. I: "Towards the Second Billion," 2. Obtained from David Healy.
7. Ibid., and sec. 3: "Issues Management," n.pag. See also Shankar Vedantam, "Drug Ads Hyping Anxiety Make Some Uneasy," Washington Post (July 16, 2001).
8. Isaac Marks, interview by author, November 1,2005.
9. David Healy, interview by author, October 9, 2005.
10. Barry Brand, as quoted in Vedantam, "Drug Ads Hyping Anxiety."
11. Brendan 1. Koerner, "Disorders Made to Order," Mother Jones 27.4- (July / August 2002), 60. As Seroxat, the drug had entered the British market two years earlier, in 1991.
12. Beth Hawkins, "Paxil Is Forever: Doctor Please, Some More of These," City Pages 23.II4-I (October 16, 2002): http://citypages.com/databank/23/II4I/article IOlSS.asp (accessed April 30, 2006).
13. Ray Moynihan and Alan Cassels, Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All into Patients (New York: Nation Books, 2005), 120; Hawkins, "Paxil Is Forever."
14. Peter Landers, "Waiting for Prozac: Drug Companies Push Japan to Change View of Depression," Wall Street Journal (October 9, 2002).
15. Ray Moynihan, "Celebrity Selling-Part 2," British Medical Journal 325.7358 (August 3, 2002), 286.
16. David Healy, The Antidepressant Era (Cambridge, Mass.: Harvard University Press, 1997), 76.
17. Mickey C. Smith, A Social History of the Minor Tranquilizers: The Quest for Small Comfort in the Age of Anxiety (1985; Binghamton, N.Y.: Pharmaceutical Products Press, 1991),67.
18. Anne E. Caldwell, "History of Psychopharmacology," Principles of Psychopharmacology, 2nd Edition, ed. William G. Clark and Joseph del Guidice (New York: Academic Press, 1978), 35; emphasis in original.
19. Morton Mintz, "Drug Success = News; Drug Failure = Non-News," The Therapeutic Nightmare: A Report on the Roles of the United States Food and Drug Administration, the American Medical Association, Pharmaceutical Manufacturers, and Others in Connection with the Irrational and Massive Use of Prescription Drugs That May Be Worthless, Injurious, or Even Lethal (Boston: Houghton Mifflin, 1965), 53-70, summarized in Smith, A Social History, 65.
20. Subcommittee on Intergovernmental Relations to Study the Safety and Effectiveness of New Drugs, as quoted in Smith, A Social History, 183.
21.Hawkins, "Paxil Is Forever."
22. Moynihan and Cassels, Selling Sickness, 23, 101.
23. David Healy, Let Them Eat Prozac: The Unhealthy Relationship between the Pharmaceutical Industry and Depression (New York: New York University Press, 2004-), 272; emphasis in original.
24. Shankar Vedantam, "Experts Defining Mental Disorders Are Linked to Drug Firms," Washington Post (April 20, 2006). See also Benedict Carey, "Study Cites Links to Firms by Psychiatrists," New York Times (April 20, 2006).
25. See for instance ShankarVedantam, "FDA Told U.S. Drug System Is Broken: Expert Panel Calls for Major Changes," Washington Post (September 23, 2006).
26. See Healy, Antidepressant Era, 61. Monoamine oxidase inhibitors (MAOIS) were so named because they increased monoamine levels in the brain, an outcome said to have antidepressive effects. sSRIs-particularly Prozac-soon eclipsed pharmacological interest in MAOIS, however, because they are comparatively safer and generate fewer side effects. Regarding chronic cases of depression, there are still claims that MAOIS are the more effective treatment.
27. Consequently, our perspective differs substantially from that of antipsychiatry gurus such as Thomas Szasz, who has insisted in a litany of popular books that mental illness is a "myth" designed to categorize and control us. As Peter Kramer and others have pointed out in brilliant rejoinders to Szasz, the net effect of his thinking about mental illness (rather than its sometimes questionable treatment) is to romanticize depression and schizophrenia by turning them into badges of political honor, symptoms of existential depth, or signs of tortured genius. Missing from Szasz's writing, in particular, is any sense of the acute, involuntary misery that depression, schizophrenia, and other illnesses cause, as well as the way they tug on hidden psychological and biological sources. See Thomas S. Szasz, The Myth of Mental Illness: Foundations of a Theory of Personal Conduct (New York: Harper and Row, 1961); and Peter D. Kramer, Against Depression (New York: Viking, 2005), esp. 63 - 84-.
28.Susie Scott, interview by author, July 13,2006.
29.Because the company's name changed shortly after it received FDA approval to treat social phobia, and because my text moves back and forth across several years, to avoid additional complexity I refer throughout this chapter to "SmithKline," even after the company technically had become GlaxoSmithKline, or GSK.
30. Cohn and Wolfe, Partners in Wellness, "Launching Paxil for the Treatment of Social Anxiety Disorder," http://membersfortunecity.com/ partnersinwellness/ id23. htm (accessed May 1,2005).
31. Healy, Antidepressant Era, 168, and Let Them Eat Prozac, 270 and 337-38 n42, which refers to Healy's unpublished 2003 essay, "SSRIS and Withdrawal/Dependence." Among a long list of sources documenting these problems are the Committee on Safety of Medicine and the Medicines Control Agency, "Dystonia and Withdrawal Symptoms with Paroxetine (Seroxat), Current Problems in Pharmacovigilance 19.1 (February 1993), I; Linda C. Barr, Wayne K. Goodman, and Lawrence H. Price, "Physical Symptoms Associated with Paroxetine Discontinuation" (letter), American Journal of Psychiatry 151.2 (February 1994-), 289; Charles Debattista and Alan F. Schatzberg, "Physical Symptoms Associated with Paroxetine Withdrawal" (letter), American Journal of Psychiatry 152.8 (August 1995), 1235 - 36; Fiona J. Mackay et al., "A Comparison of Fluvoxamine, Fluoxetine, Sertraline and Paroxetine Examined by Observational Cohort Studies," Pharmacoepidemiology and Drug Safety 6.4 (1997), 23546.
32. Healy, Let Them Eat Prozac, 27. See also David Healy and B. E. Leonard, "Monoamine Transport in Depression: Kinetics and Dynamics," Journal of Affective Disorders 12.2 (1987), 91 - 105; and Danish University Antidepressant Group, "Paroxetine: A Selective Serotonin Reuptake Inhibitor Showing Better Tolerance, but Weaker Antidepressant Effect than Clomipramine in a Controlled Multicenter Study," Journal of Affective DisorderSI8.4 (1990), 289-99.
33. Healy, Let Them Eat Prozac, 27.
34. Irving Kirsch and Thomas J. Moore, with Alan Scoboria and Sarah S. Nicholls, "The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration," Prevention and Treatment 5, Article 23 (July 2002): http://content.apa.01;g/journals/pre/S/I/23 (accessed August 14, 2006). See also Irving Kirsch and Guy Sapirstein, "Listening to Prozac but Hearing Placebo: A Meta Analysis of Antidepressant Medication," Prevention and Treatment 1, Article 0002a (1998). The articles, which share the same principal author, did not appear in a peer-reviewed psychiatric journal.
35. See for instance R. C. Casper et al., "Somatic Symptoms in Primary Affective Disorder: Presence and Relationship to the Classification of Depression," Archives of General Psychiatry 42 (1985), 1098 - 104; J. Bobes et al., "Evaluating Changes in Sexual Functioning in Depressed Patients: Sensitivity to Change of the CSFQ [Changes in Sexual Functioning Questionnaire]," Journal of Sex and Marital Therapy 28 (2002), 93 - 103; and, most recently, Anita Clayton, Adrienne Keller, and Elizabeth L. McGarvey, "Burden of Phase-Specific Sexual Dysfunction with SSRIS," Journal of Affective Disorders 91 (2006),27-32.
36. GlaxoSmithKline Inc., Paxil CRTM: Paroxetine Hydrochloride Controlled Release Tablets (Mississauga, Ontario: Health Canada), rev. November 1,2005,7-10. I discuss these issues more extensively in the next part.
37. Panorama, "The Secrets ofSeroxat" (BBG One, October 13, 2002). See also Healy, Let Them Eat Prozac, 283 - 84.
38. Healy, Let Them Eat Prozac, 284.
39. Craig J. Whittington et al., "Selective Serotonin Reuptake Inhibitors in Childhood Depression: Systematic Review of Published versus Unpublished Data," The Lanceq63 (April 24, 2004), 1341-45.
40. Gardiner Harris, "Spitzer Sues a Drug Maker, Saying It Hid Negative Data," New York Times (June 3, 2004); Barry Meier, "Two Studies, Two Results, and a Debate over a Drug," New York Times (June 3, 2004); Gardiner Harris, "FDA Toughens Warning on Antidepressant Drugs," New YOrk Times (October 16, 2004).
41. Ed Silverman, "Sales Reps Told Not to Divulge Paril Data: Drug Maker Memo Cited Risks to Youth," New Jersey Star-Ledger (September 29, 2004), citing an internal GSK memo that read: "This letter is for your informational purposes only. Although you should read the letter carefully, please do not discuss the contents with your customers." GSK'S explanation was that only Prozac had received FDA approval to treat depression in children and adolescents, so its own material was "off-label" information. But medical ethics experts argue that the company had a "moral duty" to distribute the results of negative trials, and that GSK'S explanation was suspicious.
42. Healy, Let Them Eat Prozac, 270, 337- 38 n4-2.
43. SmithKline Beecham press release, "First Medication," 2.
44. Healy, Let Them Eat Prozac, 270, 337- 38 n4-2.
45. Moynihan and Cassels, Selling Sickness, 134.
46. Healy, Let Them Eat Prozac, 24-8, 213.
47. SrnithKline Beecham PLC, "Seroxat/Paxil Fact File," sec. 3: "Issues Management: Managing the Discontinuation Issue," 3.
48. Ibid., sec. I: Foreword, 3.
49. Ibid., see. 3: "Issues Management: SB'S Discontinuation Strategy," 6.
50. Ibid., "Issues Management: Background to Discontinuation," 5.
51. Ibid., "Issues Management: Rebutting the Lilly Myths," 19, 20.
52. Ibid., "Issues Management: Key Messages," 4-, no. 6; Introduction, 3.
53. Ibid., "Issues Management: Discontinuation," 21. 54. Ibid., sec. I: "Towards the Second Billion," 2.
55. Healy, Let Them Eat Prozac, 27, 296 n96.
56.See the articles cited in notes 31, 32, and 34-.
57. The company has sincerevised this claim, though it has been reproduced several times elsewhere.
58 http://www.cohnwolft.com/Content.aspx?NodeID=I2
59. "Patient Testimonials," 1.
60. SrnithKline Beecham PLC, "Seroxat/Paxil Fact File," see. 2, "The Burden of Social Anxiety Disorder/Social Phobia," 6.
61. Colby Cosh, "You're Not Shy, You're Sick: Psychiatrists Discover a Crippling 'Social Anxiety Disorder' That Affects 13% of Us," The Report (June 19, 2000),4-9-50.
62 Ibid.
63. A direct-to-consumer (DTC) advertisement appearing in Reader's Digest (November- December 2001).
64. Moynihan and Cassels, Selling Sickness, 4-8.
65. Koerner, "Disorders Made to Order," 61.
66. Cohn and Wolfe, as quoted in Hawkins, "Paxil Is Forever," n.pag.
67. Koerner, "Disorders Made to Order," 62.
68. Cohn and Wolfe, "Launching Paxil": http://membersfortunecity.com/partners inwellness/id23.htm .
69. Ibid.
70. "Can You Imagine Being Allergic to People?" Spotlight on Health, North American Precis Syndicate.
71. "It's Not Your Fault," part of the National Mental Health Awareness Campaign, cosponsored with MTV in 2001.
72. Osnat Benshoshan, "Celebrity Public Relations: An Alternative to DTC," DTC Perspectives 2 (2003).
73. Barry Brand, as quoted in Vedantam, "Drug Ads Hyping Anxiety."
74. Moynihan and Cassels, Selling Sickness, 131.
75. Vince Parry, "The Art of Branding a Condition," MM and M: Medical Marketing and Media (May 2003), 4-6.
76. Ibid., 4-4-.
77. For elaboration see Moynihan and Cassels, Selling Sickness, and Ray Moynihan and David Henry, "The Fight against Disease Mongering: Generating Knowledge for Action," PloS Medicine 3.4- (April 2006), 0425-28, as well as essays in the same special edition by David Healy, Steven Woloshin plus Lisa M. Schwartz, and Christine B. Phillips on the selling of, respectively, bipolar disorder, restless legs syndrome, and attention deficit hyperactivity disorder.
78. "Social Phobia Inventory".
79. John R. Marshall, with the assistance of Suzanne Lipsett, Social Phobia: From Shyness to Stage Fright (New York: Basic Books, 1994-), 171-73.
80. Michelle Cottle, "Selling Shyness: How Doctors and Drug Companies Created the 'Social Phobia' Epidemic," New Republic (August 2, 1999), 27, 28.
81. Lynne Henderson and Philip Zimbardo, The Shyness Home Page (Palto Alto, Calif.).
82. Marcia Vickers, "Help for the Chutzpah-Challenged: Shy New Yorkers Turn to Support Groups, If They Get the Courage to Show Up," New York Times (April II, 1999)·
83. Ibid.
84. Harriet Goodheart, "Heimberg Ahead of the Curve in Targeting Social Anxiety Disorder," Temple Times.
85. Moynihan and Cassels, Selling Sickness, 10, citing "Health Campaigners, Fundraising, and the Growth of Industry Involvement," Health and Social Campaignerls News 6 (April 2004-).
86. SmithKline Beecham PLC, "Seroxat/Paxil Fact File," sec. 2, "The Burden of Social Anxiety Disorder/Social Phobia," 6.
