Nancy Tomes - The Great American Medicine Show Revisited - Bulletin of the History of Medicine 79:4Bulletin of the History of Medicine 79.4 (2005) 627-663
Abstract
Since the late 1800s, changes in the advertising and marketing of medicinal drugs have produced heated debates in the United States. With the emergence of the modern prescription drug between 1938 and 1951, concerns that once focused primarily on patients' use of over-the-counter drugs were broadened to include physicians and their "doctors' drugs" as well. The medical profession's growing control over their patients' drug choices inevitably heightened the scrutiny of their own performance as consumers. Although deeply divided over issues of the patient's role in medical decision making, consumer activists and physician reformers expressed similar concerns about the impact of aggressive pharmaceutical marketing and advertising on the doctor-patient relationship, and starting in the late 1950s they employed strikingly similar strategies to counter the new corporate "medicine show." Yet their efforts to promote a more rational use of prescription drugs have usually been too little and too late to offset the effectiveness of pharmaceutical advertising and mar-keting activities.
Keywords
Drug advertising, drug prescribing, health consumerism, Food and Drug Administration (FDA), Federal Trade Commission (FTC), doctor-patient relationship
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Several years ago, I came across a 1967 memorandum about drug advertising in the archives of the venerable J. Walter Thompson Company (JWT), one of the oldest and largest advertising agencies in the United States. The author, H. J. Barnum, Jr., had an unusual background: after a successful career in business, he had fulfilled a boyhood dream of becoming a physician and received his M.D. degree from Columbia in 1963. Now chief resident at a hospital in Greenwich, Connecticut, Barnum worked one day a week as a medical consultant for JWT. His memorandum, which gave a physician's perspective on drug advertising, so impressed company executives that they decided to circulate it for wider discussion. In it Barnum suggested that "the setting for a drug advertisement might well be considered as quite similar to the atmosphere between doctor and patient": in order to succeed, drug companies needed to project the qualities of a good physician—that is, they should be "interested, sympathetic, faithful, responsible and above all, willing to listen."1 Since, in Barnum's words, "the successful doctor is the one who does something about the patient's chief complaint," drug advertisements needed to make "the most direct promise of relief" from troublesome symptoms; as he enthused, "We might even hope to make the reader feel better just from seeing our ad!"2
No matter how many times I read this memorandum, especially after a night spent watching the many prescription drug advertisements that now appear on television, my first reaction is always the same: What was this man thinking? How could any rational person, much less a doctor, posit that hearing about purple pills, social anxiety, and male erectile dysfunction would make us feel better? Even if the advertisements themselves were not so cloying, the listing of side effects required by law is enough to trouble one's imagination; every good, whether it be greater tranquility or a more satisfying sex life, comes hedged with warnings about nausea, headaches, and which erections require trips to the emergency
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room. Read from the perspective of today, after almost a decade of controversy concerning direct-to-consumer advertising of prescription drugs, Barnum's assumption that drug advertisements may make us feel better just by seeing them seems remarkably naive.
Yet for all the ridicule that such advertisements have attracted in recent years, the beliefs that drug advertising serves the patient-consumer well and that it enhances the practice of modern medicine continue to shape current policy regarding drug promotion in the United States. Unraveling this paradox—of a cultural practice simultaneously celebrated as a boon to modern medicine and reviled as a societal curse—requires an understanding not just of contemporary issues, but of historical issues as well. So rather than reach for the Paxil, or shoot my television, I have chosen a more temperate and productive response—namely, to devote the 2004 Garrison Lecture to the strange and vexed history of prescription drug advertising.
In so doing, my purpose is not to deliver a sermon about the evils of contemporary prescription drug advertising on television (although I will share some of my thoughts on them in the conclusion). Rather, I want to use the history of past controversies about drug advertising to explore some bigger issues. Dr. Barnum's comments point to an important dimension of American medical practice that is worth more than an irritated dismissal: In his mind, the drug, the ad, and the doctor-patient interaction were all equivalent parts of the medicine "show"—that is, the complex process by which a doctor and a patient arrive at a therapeutic plan. The prescribing of drugs is central to how modern doctors "show" concern and exhibit their specialized knowledge, just as taking drugs is central to how modern patients demonstrate concern about their health. In learning those roles, both physicians and patients come under the powerful influence of an important "stranger at the bedside," that mysterious entity we refer to as "the market."
Of course I know that when David Rothman wrote his 1991 book Strangers at the Bedside, the strangers he had in mind were lawyers and bioethicists, but I find the "stranger" concept equally useful in thinking about the commercial matrix of health-care decision making.3 Over the last century, doctors and patients have had increasingly to reckon with the influence of the modern pharmaceutical industry, a presence tangibly evident both in extensive drug advertising and in the work of drug company sales representatives, also known as "detail men" or "detailers." Through a variety of well-funded promotional activities, pharmaceutical
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companies have had a powerful impact on how we stock our bathroom medicine cabinets and conduct our visits to physicians. The growing effectiveness of the modern pharmaceutical "pitchman" has provoked long-running debates both within and outside the medical profession.4
In fact, aggressive drug advertising is often invoked to explain why Americans apparently consume more prescription drugs than their counterparts in other developed nations, roughly twice as many per person as Europeans, for example (11 prescriptions per American per year in 2002);5 of the estimated $466 billion spent on prescription drugs worldwide in 2003, approximately half (around $215 billion) were spent in the United States.6 Advertising costs are also implicated in the higher prices that Americans pay for their prescription drugs, often twice as much as do citizens of other developed nations.7 Pharmaceutical manufacturers justify these price differentials as necessary to support the huge costs involved in the research and development of new drugs. High prices also allow pharmaceutical companies to return extremely high profits to their investors; in 2003, their return on revenues was 14 percent, compared to 5 percent for all Fortune 500 firms—a difference that keeps capital flowing into their hands.8 Of course, advertising alone does not account for these complex patterns of usage, cost, and profitability, but it
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is hard to deny its significance in light of two other striking facts: first, that the leading pharmaceutical companies spend more on marketing and advertising than they do on research and development, and second, that the most heavily advertised drugs are those most frequently prescribed by physicians.9
In an era of increasing desperation over rising health-care costs, these facts are even harder to ignore. Although prescription-drug spending currently accounts for less than 11 percent of the United States' notoriously high health-care bill, it continues to grow faster than other areas of health-care expenditure.10 For ideological as well as economic reasons, prescription-drug patterns have become a convenient platform for criticizing the American devotion to market-driven health care. Drug prices spotlight the American unwillingness to endorse two cost-controlling strategies that are widely accepted in other capitalist countries: national health insurance, and price controls on prescription drugs. For critics of these policies, prescription-drug usage serves as a useful illustration of the resulting system's tendency to overtreat some and undertreat others as a response more to their financial status than to their health condition.11[End Page 631]
While such debates are particularly heated in the United States, they are by no means unique to it. Questions about markets, costs, and choices resonate globally as other developed nations struggle with rising medical bills. National discontents have international consequences: witness the growing trend of Americans going over the border, literally and virtually (via the Internet), to buy lower-cost drugs in Mexico or Canada. Images of American excess, in the form of pill-popping patients and pill-pushing physicians, crop up in other countries' efforts to restrict "American-style" drug advertisements, as well as in guilt-ridden debates about the continued failure of wealthy nations to help poorer ones afford drug treatments for AIDS, malaria, and other deadly diseases.12
For all these reasons, the often-fierce debates now occurring over American-style drug advertising have more than parochial interest. We inevitably have to wonder: Why is this custom of aggressive drug advertising so deeply ingrained in the United States? Why have previous efforts to rein in that advertising been thoroughly frustrated? How has living with such an aggressive advertising presence affected the way doctors and patients interact? Obviously, I cannot begin to answer all those questions here. What I will do is to look more closely at the recurring debates over prescription drug advertising and its impact on the doctor-patient relationship, especially as they reflect a new kind of patient empowerment in the 1960s and 1970s.
A few caveats before I go further: my main goal here is to describe the debates about drug advertising, not to document how the torrent of advertising affected what doctors and patients "really" thought or "really" did. Much as I would like to speak to those issues, much more research remains to be done before we can adequately answer such questions. Nor do I propose to evaluate the veracity of advertising claims about specific
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drug treatments. Rather, my goal is more modest: to survey the terrain of argument about and accommodation to the changing scope of drug advertisements, and to throw up a few markers for further exploration, both by myself and by others.
To that end, I will begin with an overview of the mid-twentieth-century pharmaceutical revolution and the changes in advertising practice that accompanied it, and will then move backwards to explore how these changes were interpreted in the context of earlier debates about drug advertising. As I will show, many pre-1950 worries about the harm that drug advertising did to patients were simply widened after 1950 to include physicians. In the second part of this article, I will look at the parallel ways in which consumer advocates and physician reformers sought to counter the growing power of the commercial "medicine show" through the cultivation of new forms of information and education. Yet while they shared many common points of concern, medical and lay critics of the new-style drug advertising remained deeply divided over issues of patient autonomy and control. In the conclusion, I suggest how these historical currents shape contemporary responses to the latest innovation in pharmaceutical marketing, the direct-to-consumer advertising of prescription drugs.
The Birth of the Modern Prescription Drug
Our modern two-tier system of drug provision in which medicines are clearly divided into two categories, over-the-counter versus prescription drugs, is of comparatively recent origin. Prior to 1938, the fundamental distinction between the two—that over-the-counter drugs are safe and mild enough that consumers may self-medicate with them, whereas prescription drugs are so strong and prone to dangerous side effects that they should be taken only "under a doctor's supervision"—did not yet exist. The vast majority of medicinal drugs that Americans consumed were over-the-counter remedies, and, with the exception of narcotics, the drugs made up into doctors' prescriptions could also be bought directly by consumers. In 1938, Congress passed the Food, Drug, and Cosmetic Act, which gave the Food and Drug Administration (FDA) new regulatory power to assure drug safety, including the power to designate some drugs as "by prescription only." In the wake of the 1938 act, as Harry Marks has shown, FDA officials and drug-industry representatives waged an ideologically charged debate over the proper shape of the regulatory process. The outcome of that debate, which was codified in the 1951 Durham-Humphrey Amendment, gave pharmaceutical companies considerable power to determine what drugs should be sold by prescription only. Over the next
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decade, the methods used to promote the rapidly expanding range of so-called doctors' drugs became the subject of fierce disagreement.13
The birth of the modern prescription drug reflected dramatic changes in the pharmaceutical industry that began in the mid-1930s. After half a decade of frustration, laboratory research finally began to produce the long-sought-after "magic bullets": first sulfa drugs, then antibiotics, steroids and other hormones, and a wide range of psychoactive drugs. These provided new power to intervene in human disease processes by eliminating bacterial invaders, reducing inflammation, and altering brain chemistry. Indeed, they remain the cornerstones of modern therapeutics to this day. But their very power also made them potentially hazardous to use. The passage of 1938 law was impelled in part by a 1937 incident in which more than a hundred people died after taking an over-the-counter preparation of sulfanilamide; under the new, presumably safer system of drug provision, such tragedies might be averted.14
The pharmaceutical "revolution" of the 1940s and 1950s profoundly affected the doctor/patient relationship: as Milton Silverman and Philip R. Lee noted in 1974, whereas once patients visited doctors chiefly in search of surgery or diets, now what they wanted was a prescription drug.15 This shift had dramatic economic impact as well: the pre-1938 pattern, in which spending on over-the-counter products, also known as "proprietary" drugs, far outstripped spending on prescription drugs, quickly reversed after 1950. Between 1929 and 1969, prescription drugs grew from 32 percent to 83 percent of the total of all medicines taken by American patients.16[End Page 634]
The prescription-drug revolution also transformed the medical profession's relationship to the pharmaceutical industry. With the advent of the new wonder drugs, physicians became the funnel through which the most expensive of drug products flowed to patients. Under the American patent system, drug companies had roughly twenty years to profit from a new prescription drug; to build market share in a brutally competitive industry, they had a strong incentive to court physicians aggressively. Doctors were deluged with advertisements through the mail and the pages of their medical journals. Companies developed a highly sophisticated sales system in which "detail men" (a euphemism for drug sales representatives) visited hospitals and physicians' offices to promote their company's line of drug products. This system sought to build doctors' loyalty to a specific drug—that is, the particular brand of antibiotic, steroid, or minor tranquilizer that the company had under patent. Whereas once doctors had been a relatively small side specialty in drug advertising, they now became its main target.17
These postwar changes prompted new attention to drug marketing customs, yet the 1950s debate over their propriety did not start from a blank slate. Worry about prescription drug advertising occurred against the backdrop of a long tradition of concern about the evils of proprietary drug advertising. Despite the vigorous efforts of the ethical pharmaceutical companies to maintain their distance from their proprietary counterparts, some critics saw troubling similarities between the old proprietary "medicine show" and the new promotional culture of the postwar pharmaceutical industry. Before looking more closely at the post–World War II debates about drug advertising, therefore, we need to step backward in time to consider an earlier generation of debates about the dangers of the medicine show and its characteristic forms of "ballyhoo," or extravagant advertisement.
The Birth of Ballyhoo
Concerns about extravagant advertisements reflected the remarkable rise of the proprietary drug industry, also referred to colloquially as "patent medicine," following the American Civil War. Its development is a story familiar to historians of medicine, largely due to the pioneering work of James Harvey Young. More recently, the proprietary drug industry has become central to historical accounts of the rise of a modern consumer-oriented economy, defined as an economy dependent for its
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growth on increasing sales of goods designed for personal consumption, as opposed to industrial use. As Jackson Lears has shown, by becoming the first national companies to conduct extensive national advertising campaigns, proprietary medicine manufacturers helped to create the modern advertising industry, which in turn bankrolled the rise of new forms of mass media. The proprietary drug industry also helped bring into existence the modern conception of consumer protection. During the Progressive Era, reformers successfully argued that in order to maintain a healthy market economy, state and federal governments had to ensure that goods offered for sale met minimum standards of safety. This conviction led to the landmark passage of the 1906 Pure Food and Drugs Act, which set basic requirements concerning the manufacturing and labeling of medicines. The regulatory impulse also led to the 1914 creation of the Federal Trade Commission (FTC), which subsequently obtained authority to regulate advertising practices in order to ensure fair business competition.18
This combination of elements—an expanding proprietary medicine industry, professional advertising, and consumer regulation—also appeared in other Western countries at the same time, but American drug companies early distinguished themselves by their heavy emphasis on advertising and marketing as part of their competitive business strategy. Such an emphasis was encouraged by the American legal system, which treated advertising as a fundamental aspect of a healthy market economy that should be restrained only when it interfered with conditions conducive to fair trade. This privileged status was reflected in the early twentieth-century regulation of drug advertisements, which gave their oversight not to the Food and Drug Administration but to the Federal Trade Commission. Until 1938, the FTC could prosecute against misleading advertisements only on the grounds that they were unfair to other business competitors, not to consumers. When the right to regulate on behalf of consumers was finally written into law in 1938, the FTC, not the
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FDA, retained the oversight of advertisements. (Only in 1962 did the FDA gain regulatory authority over prescription drug advertising.)19
Until the late 1930s, the proprietary medicine industry enjoyed a relatively free hand in its advertising practice. While spending virtually nothing on product research and development, most companies invested heavily in advertising and marketing campaigns. Many large firms began to invest in sophisticated market research to determine people's wants and fears, in order to make their advertising campaigns more effective. Playing to the American romance with science in this period, advertising campaigns sought to portray proprietary drugs as products of the new laboratory science, and interwar advertising agencies such as the J. Walter Thompson Company began to subscribe to medical journals and to hire scientific "experts" as consultants (as they would Dr. Barnum several decades later).20
An even more striking innovation in interwar drug advertising was its colonization of commercial radio. The tradition of the traveling medicine show, long a favorite in remote rural areas, became "etherized," so to speak, forming (along with its urban cousin, vaudeville) the foundations of a new national style of entertainment. The radio announcer assumed the role of the medicine-show barker, delivering the sales pitch in between the songs, jokes, and skits. A number of early radio stars—among them George Burns, Gracie Allen, and Red Skelton—were veterans of the medicine-show circuit. As Americans became confirmed radio
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listeners in the 1930s, they grew accustomed to the now-familiar alternation of entertainment and advertising, in which the line "and now a message from our sponsors" was followed by promotions for Pepsodent toothpaste, Fleischmann's yeast, Crazy Crystals, and the like.21
The growing volume and changing nature of drug advertising attracted intense criticism in the interwar period, from both physicians and laypersons. Owing to their greater psychological sophistication, their misleading use of pseudoscience, and their mass promotion via modern media, the new advertisements seemed an even more dangerous force than the old-timey patent medicine advertisements. In addition, World War I had left American intellectuals with a profound distrust of propaganda and a growing fear of totalitarianism; for them, advertising came to exemplify the looming dangers of a new kind of "mass culture" and "mass man." Conservatives and liberals alike bewailed the ad-enthralled American, pictured either as the wide-eyed, slack-jawed mark at the patent-medicine show or as the passive listener dazzled by his "master's voice" on the radio. American democracy would count for very little, warned the adman-turned-social-gadfly James Rorty in his book Our Master's Voice, if it succumbed to what he variously termed "rule-by-advertising," "corporative forms of fascism," and "mass moronism."22
While appealing as ideological weapons, these portrayals of American consumers as morons were no doubt overstated. Market surveys and other contemporary sources suggest that consumers had very complicated and often hostile reactions to the flood of advertising messages they encountered in everyday life. Then (as now), a clever advertising campaign might indeed induce a large number of people to try a particular
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product, but unless that purchase satisfied, and consumers felt that the product had some value for their health, there would be no repeat purchase. As advertising agencies well knew, hearers quickly built up a resistance to the pitch.23
Indeed, a studied disdain for advertising became the mark of the sophisticated American of the interwar era. Intelligent people insisted that they (like physicians) were too smart to be taken in by "ballyhoo," a slang word for the carnival barker's spiel that came to signify any form of extravagant advertisement. Falling for the pitch was the special failing of the uneducated, the country folk, and the newly arrived immigrant. This disdain appeared in popular as well as academic writings; for example, the magazine Ballyhoo was founded in 1929 solely to lampoon advertising, and had a circulation of more than a million and a half readers by 1931. Ballyhoo appealed to the ad-weary American, as in this mock-plea to spare "Mr. T. Sufferin Sapp" from exaggerated advertising claims (Fig.1).
The magazine frequently made fun of the proprietary drug industry. For example, a 1932 ad-spoof profiled the Ballyhoo Institute and Medical Center "for the free treatment of all those suffering from advertising diseases who otherwise might have to buy expensive nationally advertised medicines," and included a sketch of a "gallant interne" on skis "rushing out in the night at 60 below zero to cure a stubborn case of dandruff" (Fig. 2).24 Similarly, the back cover for the December 1932 issue reworded the Mother Goose nursery rhyme "Solomon Grundy" so that he expires on Sunday after suffering a string of "advertising diseases," including pyorrhea, foot itch, head cold, and acid mouth (Fig. 3).25
Yet for all this studied disdain, the tidal wave of proprietary drug advertising clearly did have an impact on consumers' behavior. Hearers may have dismissed the ubiquitous advertisements with a shrug or a wink, but the rising consumption of heavily advertised products, such as the constipation remedies that James Whorton has studied, and the
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Figure 1
"Why don't the consumers advertise?" From Ballyhoo, 1933, 4 (5): 6.
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"vitamania" documented by Rima Apple, attests that they had an effect.26 By the late 1930s, Americans were spending almost $400 million per year on proprietary drugs—a scale of expenditure that greatly annoyed physicians, who felt that the money would be better spent on paying for their services. Even as they praised the wonders of modern medicine, proprietary drug companies developed advertising campaigns designed to encourage exactly that trade-off: advertisements for many products subtly suggested that self-medication was a good way to allay fears of "serious disease" and thus avoid a more costly trip to the doctor.27
Interwar proprietary drug advertising, with its connection to commercial radio and its creative appropriations of medical science, provoked considerable angst. Much like prescription drug advertising on television in the late 1990s, it served as a potent symbol of commercial excess. The dangers of overzealous drug promotion and use became a common theme among many educators and reformers during the New Deal era. To counter the greater potency of the new drug advertising, they urged Americans to cultivate a new wariness toward what they likened to a modern-day snake-oil salesman. Proprietary drugs were a major focus of the newly revitalized consumer movement of the 1930s, evident in the publishing success of the "guinea pig books," starting with Arthur Kallet and F. L. Schlink's 1933 book, 100,000,000 Guinea Pigs (the guinea pigs were the American people, being stuffed full of dangerous food and drugs).28
Physicians also decried the new-style proprietary drug advertising of the interwar period. As we know from the work of John Harley Warner and Harry Marks, physician-reformers had long wanted to improve
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Figure 2
"The Ballyhoo Institute and Medical Center." From Ballyhoo, 1932, 3 (4): 26.
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Figure 3
"Ballyhoo's Mother Goose." From Ballyhoo, 1932, 3 (5): back cover.
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therapeutic practice, including drug prescribing. Therapeutic reform required carefully distinguishing physicians' use of drugs from the indiscriminate promotion of proprietary medicines. Beginning in the early 1900s, the American Medical Association (AMA) devoted substantial resources to combating the evils of quacks, frauds, and patent-drug makers. In public discourse, doctors invariably presented themselves as scientific men impervious to deceptive drug advertising—a view obviously shared by the drafters of the FTC's founding legislation, which exempted advertising to physicians from its official oversight.29
Within their own circles, medical leaders did indeed worry about doctors' susceptibility to the rising tide of direct mail advertising for proprietary drugs—as William Osler did in 1902, when he railed against the "bastard literature which floods the mail," designed to take advantage of the "innocent credulity of the regular physician."30 Still, prior to the 1940s, physicians clearly considered the chief harm of proprietary drug advertising to be the misinformation it stuffed into patients' heads, not their own. Their sense of being above the fray was likely reinforced by the restrained style of advertising used by the ethical pharmaceutical companies, which promoted their products only to physicians. The kind of tasteful, uplifting advertising campaigns employed by Parke Davis or E. A. Squibb seemed a far cry from the ballyhoo promoted by their proprietary counterparts.
During the 1930s, lay and medical critics of proprietary drug advertising obviously had much in common, including a shared dislike of the proprietary medicine industry, a disdain for the credulous consumer taken in by its misleading advertisements, and a belief in the importance of governmental regulation to protect public health. Yet neither group had kind words to say for the other, largely because they had a very different sense of how much patients needed to know in order to protect their own therapeutic interests. Consumer advocates believed that laypeople needed to become hypervigilant about their health and to work hard to educate themselves about medical matters; the vast majority of physicians found this aspiration at best nonsensical, and at worst, a
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dangerous encroachment on their authority. As we shall see, those contrary views would only intensify in the post–World War II period.31
The New "Medicine Show"
Far from easing these deep-seated concerns about drug promotion, the changes in the pharmaceutical industry after 1945 only widened the scope of criticism. Although patients continued to take the lion's share of the blame for "irrational" prescription drug use, doctors came under mounting criticism for their failures to resist the drug companies' high-powered sales tactics. As physicians assumed a more visible role as the middlemen between the pharmaceutical industry and the public, they faced greater scrutiny of their own credentials as rational consumers.
While my focus in what follows will be on debates about prescription drug advertisements, let me emphasize that concerns about over-the-counter drugs by no means disappeared after 1951. That is a separate story, which requires its own telling. Nor can I do more than briefly mention another important aspect of postwar drug culture: namely, pharmaceutical companies' efforts to cultivate public interest in prescription drugs. While agreeing not to advertise prescription drugs directly to patients, primarily because doctors strongly opposed it, companies continued to do so-called institutional or goodwill advertising, which promoted positive views of medicine, science, and prescription drugs in general. For example, a 1957 Parke Davis advertisement that appeared in mass-circulation magazines such as the Saturday Evening Post sought to counteract complaints about high prescription drug prices; it showed a man reassuring a male companion that even though it cost nine dollars, the prescription drug he was taking was really "a bargain" because it kept him from
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missing work. Drug companies also used public relations firms to place stories about new drugs in newspapers and magazines. For example, Pfizer paid to have a special advertising section on antibiotics, titled "Report from Pfizer," appear in the Sunday New York Times on 31 March 1957.32
Although these corporate efforts to mold public opinion attracted some criticism in the 1950s, by far the greater outcry concerned the pharmaceutical industry's promotions aimed at physicians. In contrast to their low-key approach in the past, the ethical houses now began to engage in marketing practices that struck some observers as disturbingly similar to their proprietary counterparts. Instead of standing apart from the proprietary tradition of "ballyhoo," the ethical firms now seemed bent on extending its sway to include the medical profession. Whereas physicians had once seemed safely removed from the commercial aspects of drug promotion, they now seemed in danger of being tarnished by its excesses. The new corporate "medicine show" unsettled long-standing distinctions between the ethical and proprietary sectors of the trade, and precipitated new debates about the proper limits of commercial behavior in the medical field.
To be sure, the new prescription drug marketing differed in very important ways from the old-style medicine show. As the large, reputable ethical houses such as Pfizer, Merck, and Eli Lilly emphasized, theirs was the scientific cutting edge of drug discovery and manufacture, far from the old days of slapping labels on patent-medicine brews made in somebody's bathtub. These companies emphasized that the products they promoted so heavily were truly effective drugs, such as antibiotics and steroids; educating doctors about such life-saving developments was entirely different from the old ballyhoo. This sense of moral purpose came across clearly in the training of detail men, who, as Jeremy Greene has shown, "re-invented themselves as skilled and service-oriented professionals, the champions of an efficiently modern therapeutics."33
Yet the growing professionalism of postwar detail men could not assuage mounting concerns about the new scale and scope of the industry's
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promotional culture. As Greene notes, the professionalism of the detail man showed to best effect in the privacy of the doctor's office and hospital examining room. Other, less professional forms of promotion occurred out in the open, more visible to critical view. Physicians raised in the old-school tradition that advertising and professionalism did not mix looked askance at the deluge of direct mail advertising, the glossy display advertisements in medical journals, the social and educational events sponsored at medical meetings, and the free samples and giveaways brought by detailer "Santa Clauses" (as one wag nicknamed them). Such promotional tactics threatened to compromise doctors' sense of professionalism, a professionalism honed through decades of opposition to the advertising tactics of the proprietary drug industry.34
Concerns that the ethical pharmaceutical companies, so long an ally in the war against commercial excess, had begun to adopt the tactics and mind-set of their proprietary counterparts clearly unsettled some leaders in the medical profession. As they were well aware, the postwar pharmaceutical industry had grown intensely competitive as well as profitable, and companies depended on aggressive promotions to doctors for their success. The ethical companies repeatedly tried to reassure the profession that their marketing and advertising policies would always adhere to the high road of life-saving and education. Yet, perhaps inevitably, observers both within and outside medicine began to worry about the negative impact of the new-style drug promotions on physicians' prescribing habits and the doctor-patient relationship.35
Harry Dowling, the chair of the AMA's Section on Experimental Medicine and Therapeutics, expressed these worries in a widely-cited 1957 speech to his fellow physicians. "Within recent years," he observed, "the drug industry has discovered that the techniques that had been used so successfully in the advertising of soaps and toothpastes and of cigarettes, automobiles and whiskey could be used successfully to advertise drugs to doctors"; this new drug advertising, in his opinion, was "flamboyant," "incessant," and "without question confusing."36 While acknowledging the enormous value
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of modern drugs, Dowling warned against letting competition and profit-taking, not education and life-saving, become the real levers of the promotional system. "The battle front of today ha[d] shifted": it was no longer "false advertising to the public" that the AMA needed to concern itself with, but rather "false advertising to the doctor," he concluded.37
Criticism of drug promotion echoed larger reservations about the direction of post–World War II consumer culture. Like other industries of the era, pharmaceutical companies promoted their capacity to deliver progress in the form of a constant flow of "new and improved" products. But in the 1950s, critics began to question the equation of newness with progress. Particularly influential was the work of Vance Packard, who published three best-sellers between 1957 and 1960 decrying the wastefulness of American consumer capitalism. Companies were not delivering new and better products, he suggested, but were instead promoting a new kind of planned obsolescence. In order to sell more products at ever-higher prices, firms misrepresented minor changes in design as major improvements, while simultaneously blocking useful innovations that might bring real progress in cheaper forms.38
To be sure, discovering new drugs seemed a far more serious business than changing the tail fins on automobiles or offering appliances in new color combinations—yet some observers saw parallels between the way drugs and other commodities were being produced and promoted. The new, more expensive drug was not always demonstrably better than the older, cheaper ones it replaced, and advertising budgets, not clinical efficacy, seemed to be driving changes in physicians' prescribing habits. Testifying before Congress in 1961, Dale Console, former director of research at Squibb, claimed that drug products were starting to "change like women's hemlines" and warned that "rapid obsolescence is simply a sign of motion, not progress."39 In the same hearings, the Johns Hopkins pharmacologist Louis Lasagna suggested that the "problem of the built in obsolescence of drugs" reflects the "miserable quality of drugs that are issued each year." As a consequence, "the advertising agencies are being asked to sell to the medical profession a whole bushel basketful of sows' ears for silk purses each year"; it was no wonder, he concluded, that
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"advertising excesses" were followed by "so-called product failures and that obsolescence sets in."40
These criticisms dovetailed with physicians' recognition of what came to be known as the "therapeutic cycle": a new prescription drug would be aggressively promoted to doctors and covered in glowing media stories that excited patients' interest; the drug would then come into wide use and begin to be overprescribed for ailments it could not cure; and as more people used it for longer periods, problems with adverse side effects and therapeutic effectiveness would inevitably appear. Although common to all drug classes, this cycle was particularly pronounced among psychoactive drugs.41 Starting with the 1950s debate over the minor tranquilizer Miltown, the idea that drugs were being used to medicate "ordinary problems of living" brought what Gerald Klerman referred to as the "pharmaceutical Calvinists" out in force (as it continues to do in more recent debates about Prozac and Paxil).42 As Elizabeth Watkins has shown, similar complaints arose about prescribing hormones to offset the female aging process.43
In explicating the causes underlying the therapeutic cycle, most commentators harped on patients' failings. It was primarily Americans' foolish pursuit of perpetual youth and happiness and their eagerness to find "a pill for every ill" that led to prescription drug overuse and misuse. Direct advertising of prescription drugs might be limited to physicians, but the placement of news stories and magazine pieces assured that patients learned about new drug breakthroughs and asked for them by name. In antidrug jeremiads, the Miltown-popping American of the 1950s was clearly the lineal descendent of the yeast-eating, elixir-guzzling mark of the pre-1938 era. But in some accounts, a different kind of scenario began to emerge as well: a sensible person, confused by the
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welter of commercial promotions and willing to abide by scientific opinion, goes to the doctor for advice, only to find that the doctor is too busy to talk about the everyday problems of living and just wants to write a prescription, so as to move on quickly to the next patient.44
Undoubtedly neither stereotype, the pill-happy patient or the pill-pushing physician, fit the complexity of patient and doctor behaviors in the wake of the prescription-drug revolution. But whatever the reality, the medical profession undoubtedly faced increasing responsibility for their patients' use and misuse of the new prescription drugs. In the pre-1938 period, patients had only themselves to blame when they fell for a misleading advertising campaign and purchased an ineffective or unsafe proprietary remedy. With the creation of the new prescription drug system, patients had to depend upon physicians to select their drugs for them; the medical profession acted as their "learned intermediaries," to use the legal term introduced in the 1960s, appointed to guard patients against unwise and dangerous choices.45 Thus doctors became increasingly responsible, at least in some patients' eyes, for the price, efficacy, and side effects associated with the so-called doctors' drugs. Inevitably, reservations about how well doctors were performing their duties in this regard led to renewed warnings that consumers had better watch out for themselves.
The exemplar of this new consumer wariness was Consumers Union (CU), a nonprofit organization founded in 1936 to do research on the relative merits of consumer products and services. From the outset, CU's publication Consumer Reports contained articles on over-the-counter drugs;
[End Page 650]
with the expansion of the drug industry in the 1950s, it widened its coverage to include prescription drugs as well. In 1961, CU published a compilation of articles on drug topics in a book titled The Medicine Show, the first of a new kind of consumer-oriented guide book (Fig. 4). While acknowledging the value of new drug discoveries, the book warned that they were being promoted overzealously. As CU's head, Dexter Masters, wrote in the preface, a long, hard look at drug advertisements suggested the "plain truth" that "we are here in the presence of something irrational."46 To protect themselves, consumers needed to become more aware "of the differences between genuine advances in medical research and the 'miracles' of drug advertising"; the chapters on prescription drugs sought to provide "a guide for laymen to the half-revealed world that lies beyond the prescription pad."47 After describing the growth in direct mail advertising to physicians, pharmaceutical company–sponsored activities at medical conventions, and the use of detail men, the book warned that "the spirit, the values, and the tactics of the patent medicine promoter now hold sway over the 'ethical' drug."48
The concerns that gave rise to The Medicine Show found their counterpart among politicians and journalists who observed the new axis of collaboration between organized medicine and the pharmaceutical industry with a jaundiced eye. On the legislative front, Democratic congressmen, most prominently the Tennessee senator Estes Kefauver, began to investigate prescription drug pricing and promotion.49 Journalists such as John Lear of the Saturday Review and Morton Mintz of the Washington Post wrote extensively and critically about prescription-drug issues. These skeptics coalesced into an informal reform coalition, dedicated to exposing and controlling questionable aspects of industry and physician behavior through the use of modern law and economics. In effect, they offered themselves as a consumer-friendly alternative to the pharmaceutical "stranger at the bedside."50[End Page 651]
Meanwhile, physicians were expressing their own concerns about the impact of drug advertising on their profession. In articles and editorials in medical journals, as well as in testimony at the many congressional hearings about prescription drugs held in the late 1950s and 1960s, doctors worried that too great a reliance on the therapeutic advice of a profit-oriented pharmaceutical industry would cloud their clinical judgment. As Dr. Charles May warned in a widely cited 1961 article published
[End Page 652]
in the Journal of Medical Education, "the traditional independence of physicians and the welfare of the public are being threatened by the new vogue among drug manufacturers to promote their products by assuming an aggressive role in the 'education' of doctors."51 To be sure, not all doctors shared May's sense of urgency; many felt confident that their scientific training thoroughly equipped them to reject any unsubstantiated or extravagant claims pitched their way. Yet professional leaders continued to worry that the average physician was not really performing his or her role as a therapeutic judge. The preference for brand names over generic drugs was a case in point. As Haskell J. Weinstein, former medical director of a Pfizer division, observed in 1961: "[The physician] has been taught, one might almost say brainwashed, to think of the trademark name of the drug at all times"; in place of objective information about the drug's efficacy or cost, "he is seduced with gimmicks of all sorts in an attempt to make him loyal to a particular company or a particular drug, with relatively little attention being paid to the specific merits of the drug in question."52
The potential dangers of misleading prescription drug advertising were compounded by the growing fragmentation and specialization of American medical practice, which meant that general practitioners were as likely to be prescribing potentially addictive psychoactive drugs or risk-laden antidiabetic remedies as were their specialist colleagues. As a consequence, therapeutic reformers within the profession worried that the goal of rational prescribing—the right drug in the right amount at the right time—was retreating even further from the medical profession's grasp. Once viewed as impervious to misleading advertising, the American doctor now seemed in danger of becoming as confused as his patients. The Medicine Show observed in 1961 that consumers, forced for years to listen to conflicting claims about proprietary drugs, "cannot help but feel a sympathetic uneasiness for our physicians, now subject to so intensive and extravagant a hard sell on behalf of the drugs they prescribe."53
Widespread uneasiness about the new drug promotions contributed in significant ways to the landmark 1962 Kefauver-Harris amendments, which
[End Page 653]
expanded the FDA's regulatory powers to require evidence of both drug efficacy and safety before a product went on the market. Admittedly, it was drug safety, not advertising, that finally propelled those amendments into law after years of legislative conflict and stalemate. But concerns about American physicians' inability to handle the corporate blitzkrieg of drug promotions certainly strengthened reformers' convictions that in the United States the preapproval testing of prescription drugs had to be strict, since once a drug was on the market, there were few reliable ways to modify its use. These conditions helped explain the seeming irony, as noted by the University of Edinburgh professor Derrick Dunlop in 1973, that "in the United States, the home of big business and free enterprise, the control of medicines should be more bureaucratically rigid than in the United Kingdom with its so-called socialized medicine."54
But the strengthening of the FDA's approval process in 1962 hardly put an end to the cycle of controversy. As Philip Hilts has documented, the post-Kefauver FDA faced an enormous challenge in implementing its new regulatory powers. In the first place, the agency never received sufficient funding to do all that the U.S. Congress required of it. In addition, it faced extraordinary pressure from competing interest groups: too vigorous an assertion of its regulatory powers brought outraged reactions from the pharmaceutical companies, while too lax an oversight of drug safety outraged consumer advocates. Policymaking occurred within a highly polarized ideological context, in which drug industry representatives characterized any tightening of regulatory policy as the first step toward socialized medicine, while consumer advocates warned that a federal agency too much under the sway of business interests would lead to another thalidomide tragedy.56[End Page 654]
These general problems were evident in the FDA's efforts to regulate prescription drug advertisements, a responsibility moved from the Federal Trade Commission to the FDA under the terms of the 1962 Kefauver-Harris amendments. FDA officials and representatives of the pharmaceutical companies argued endlessly over the agency's guidelines for accuracy and "fair balance" in such advertisements. While FDA officials complained about the industry's lack of cooperation, industry representatives portrayed the agency's efforts as dangerous encroachments on the doctor's right to supremacy in clinical decision-making, on the American business community's right to free speech, and on the patient's right freely to choose treatment.57
Although individual physicians were concerned about prescription drug promotions in the 1960s, the issue did not assume a high priority for organized medicine as a whole. Whereas the AMA had taken a leading role in battles with the proprietary industry before 1940, its political energies shifted in the postwar era to fighting off the threat of national health insurance. The federal government, not the pharmaceutical industry, loomed as the "stranger at the bedside" most to be feared. Testifying before the U.S. Senate in 1971, Dr. Robert Seidenberg noted the "bitter irony" of the AMA's celebrated public relations campaign against socialized medicine in the 1950s, which included the wide circulation of Luke Fildes's famous painting The Doctor, portraying a physician at his patient's bedside: while striving to convince "the public . . . to keep the third party (government) out of this picture," Seidenberg concluded, the AMA neglected to mention "another third party . . . waiting in the wings"—namely, the drug industry, which the AMA "deemed a more acceptable (or more generous) bedfellow."58 As Silverman and Lee noted in their 1974 study, this stance may well have been influenced by the AMA's dependence on the revenue from prescription drug advertisements placed in its journals.59
As Seidenberg's testimony suggests, commentaries on the problem of drug promotion took on an increasingly sharp tone in the 1970s. Influenced by changes outside medicine—including the civil rights movement, second-wave feminism, the environmental movement, and the more aggressive brand of consumer advocacy being championed by
[End Page 655]
Ralph Nader and his associates—critics both within and outside the medical profession became much more outspoken about the flaws of modern medicine in general, and the dangers of overzealous drug promotion in particular. As Susan Speaker found in a content analysis of popular magazine articles, hostility toward medical authority grew markedly over the 1970s. Lay consumer activists tended to portray all doctors as "dupes" of the pharmaceutical industry, while doctors returned the favor by harping on patients' scientific ignorance and irrationality. A blame game flourished over the question of who was more at fault for the misuse of prescription drugs, the irrational patient or the irrational doctor, and who was fighting the better fight against inappropriate drug use, consumer activists or the medical profession. This distrust made it very hard for lay and physician critics to act upon their common concerns about the modern pharmaceutical industry.60
For all their squabbling, lay and physician reformers came up with some strikingly similar strategies for countering the pharmaceutical "stranger at the bedside." Growing numbers of patients sought out more consumer-oriented guides to modern prescription drugs, starting a "consumer health information" revolution that continues to this day.61 Likewise, doctors sought to improve rational prescribing through better teaching of clinical pharmacology and more-scientific guidelines for treatment. They also sought out not-for-profit sources of drug information, such as the Medical Letter, a review of current treatments begun in 1958 under the aegis of Consumers Union that, like Consumer Reports, accepted no advertising.62
And yet, despite these similarities, patient and physician reformers found little common ground to act together in the 1960s and 1970s, chiefly because they differed sharply over how much information and
[End Page 656]
autonomy patients needed in order to make informed health-care choices. A particular flash point for disagreement was the disclosure of side effects, which long before the 1961 thalidomide tragedy had begun to concern some patients. The recurrent downside of the drug-promotion cycle, in which the miracle drug turned into a menace, reinforced consumer advocates' growing insistence that patients had to have a full understanding of all potential risks before taking a drug. Many physicians felt that prolonged discussion of side effects was counterproductive, in that it influenced overly "suggestible" patients to imagine side effects and discouraged their use of valuable medication, a difference in perspective between health-care professionals and patients that still persists today.63
Different conceptions of patient entitlement to information played out in heated battles over the development of patient-education leaflets, which were promoted as a consumer-protective counterpoint to overzealous drug promotion. They were first developed by the FDA for distribution with oral contraceptives in 1970, and the agency then undertook a pilot program to test the feasibility of doing the same for all drugs. But as Elizabeth Watkins has documented, there was so much controversy over the leaflets that the program was never extended, and commercial groups—notably retail pharmacists—reluctantly took up the work of supplying educational leaflets for the vast majority of drugs.64
I cannot delve further into the great leaflet controversy here, but let me just note that, in characteristic American fashion, the majority of drug information eventually made available to patients came from the commercial sector, not the federal government. This did not mean that
[End Page 657]
the information provided was inevitably biased: most retail pharmacies used leaflets developed by the United States Pharmacopoeia, a not-for-profit standards association. But the post-1970 elaboration of both drug leaflets and patient counseling inadvertently reinforced the belief, held by many patients, that the drugs they were receiving had been certified by the FDA as safer than they ever could be.65
Even more problematic was another response to consumers' demands for more drug information that emerged after 1980: namely, the weakening of long-standing restraints on the advertising of prescription drugs directly to patients. With Ronald Reagan in the White House, drug companies began to test the limits of the FDA's resolve to block such advertising. They portrayed drug advertisements aimed at consumers as a logical response to patients' desire to make their own health-care decisions. Yet while the companies advocated this change as a consumer-friendly reform, consumer advocacy groups strongly objected to the direct-to-consumer (DTC) advertising of prescription drugs, pointing to its expense as well as its potential to encourage unrealistic expectations of the drugs. The institutional pressure for DTC advertising came from the pharmaceutical industry, not from the organized consumer movement. After a decade of efforts to restrain the growth of such advertising, the FDA eventually decided in 1997 to loosen its restrictions, on the grounds that it was better to allow frank advertising and to regulate it carefully, than to encourage the proliferation of misleading and confusing forms of indirect advertising. Thus began the explosion of spending on prescription drug advertising in the mass media, which increased from $600 million in 1996 to $3.5 billion in 2003.66
Conclusion
This newest innovation in drug promotion has prompted yet another round of intense argument about the proper boundaries of drug advertising. Although commentators often present the DTC advertising of prescription drugs as a brand-new development in American consumer
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culture, the current controversy is but the latest chapter in a long-running debate about the modern "medicine show." As this account has demonstrated, changes in the selling and marketing of medicinal drugs have long been associated with heated debates over the same set of questions: do advertisements educate or brainwash patients and doctors? do they exaggerate or create disease conditions merely to sell more drugs? and, who should decide what is a "real" medical problem, the patient or the doctor? We can also observe similarities in the strategies of containment that patients and doctors have developed to offset the power of the pharmaceutical "pitch": both have long sought a clearer scientific standard to act as a yellow line to keep medicine "within the guardrails" of true progress. Thus two trends often seen as opposed to or in isolation from one another can better be understood as mirror images: the rise of the modern health consumer, ever vigilant in defense of his or her health, has its corollary in the striving of the modern physician to be a "rational prescriber." The proliferation of lay-oriented guides, starting in 1961 with CU's The Medicine Show and culminating in the many volumes available today offering consumers advice about the "best drugs," has had its medical analog in the Medical Letter and, more recently, the rise of evidence-based medicine and "Cochrane groups," which promote a rigorous review of large-scale clinical studies as the basis for the individual physician's treatment recommendations.67
While these strategies have been productive of much good, this history suggests an inescapable conclusion: that they are usually too little and too late truly to balance the flywheels of commerce. From the 1930s to the present day, the expectations that if they would just work a little harder, patients and doctors could get ahead of the commercial wave, have proved impossible to fulfill: by the time they have a firm critical grasp of the value of Drugs A and B in the treatment of Medical Problem C, the promotion has moved on to Drugs X and Y and Medical Problem Z. It seems a fact of modern life that the commercial forces of education and persuasion will always be more nimble and pervasive than their nonprofit alternatives. This advertising juggernaut cannot be deflected
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by what I think of as a "more information please" strategy—that is, making more information available to consumers—particularly since so much clinical research is now funded by pharmaceutical companies.68
Is that really such a bad thing? Is the current outcry over pharmaceutical promotions and those pesky DTC advertisements just another episode of Americans' pharmacological Calvinism? Certainly the Justice Department thinks not, and has begun to scrutinize pharmaceutical company gifts to physicians very carefully. To stave off legal action from the Justice Department, the Pharmaceutical Research and Manufacturers of America (PhRMA) voluntarily adopted a strict new code on gifts to physicians, effective 1 July 2002, that forbids any promotional gifts or services with no direct benefit to patients. The Department of Health and Human Services' Office of the Inspector General issued its own guidelines in 2003, and many medical societies, among them the American Medical Association and the American Pediatrics Association, have developed their own policies on these issues. The long-term effects of this flurry of guideline-adoption remain to be seen, but they have clearly had an impact on physician-industry relations.69 In contrast, the FDA shows little inclination to reverse its 1997 decision to loosen the direct-to-consumer advertising of prescription drugs. Despite intense criticism concerning the expense and value of DTC advertisements, the FDA continues to portray them as a useful source of information. According to a survey reported in FDA Consumer in 2003, "doctors say that, for the most part, the ads help people more than hurt them."70 The draft revisions to the 1997 guidelines posted in February 2004 (which are not yet accepted) aim primarily at improving the presentation of risk information.
So what about us? Should we, like our grandparents before us, walk away from the modern medicine show with a wink and a shrug, laugh it off as just one more episode of the national penchant for ballyhoo? I think not: there are some big issues that we cannot afford to dismiss as a mere "myth of overmedication." However appealing the rationalization
[End Page 660]
that the advertisements do not really affect us, remember the statistics I quoted at the beginning of this paper: the most heavily advertised drugs are the most frequently prescribed. Are you truly convinced that those are really the best drugs? If you are, do you really believe that Americans should pay so much more for them than everyone else?71
These questions are worthy of serious reflection, but they hardly begin to scratch the surface of what to me is the heart of the problem. The comparatively freewheeling nature of American medical practice—in which limits on how physicians practice and what treatments they offer are set primarily by market forces, and in which patients are encouraged to stand up for their own interests—creates what economists quaintly term "perverse incentives" for the overtreatment of affluent patients and the undertreatment of poor ones. Thus we get the worst of both worlds: an upward spiral of both drug use and drug costs that still leaves the health problems of important segments of the population untouched.
The current unsettled state of doctor-patient relations makes it doubly difficult to tackle these problems. While it was much needed, the revolt against old-fashioned medical authority has left in its wake a profound confusion as to who is to decide what is rational treatment, the doctor or the patient. Some physicians today take the point of view that they should not be the ones to judge what symptoms to treat: if a patient wants the purple pill or Viagra, they should prescribe it, as long as it will not be harmful. To do otherwise seems to constitute a now-unacceptable kind of medical paternalism. Nor does the turn to evidence-based medicine and Cochrane groups, which derive their recommendations from large-scale clinical studies, necessarily help in resolving personal prescribing dilemmas. A patient may reasonably ask if studies based on huge samples of people mask individual variations that may make one drug work for me and not for you. How convincing are references to large-scale studies going to be, for example, to a schizophrenic patient eager to try the extremely expensive antipsychotic drug Zyprexa because she has been told it has fewer side effects?
Hence we come to appreciate the real-life politics of the pharmaceutical "quick fix." If you or a relative have ever tried to get your cholesterol down, or reduce your blood pressure, or escape a major depression
[End Page 661]
through diet, exercise, and psychotherapy, you know that it can be extremely hard. Who can deny the allure of the quick fix? But after fifty years' experience with the wonder drugs, we can say with confidence that there is no quick fix: the pill combined with life-style changes usually works infinitely better than the pill alone. Yet it remains far easier for most Americans to get the pill than to find reliable, affordable therapists or nutrition counselors.
Individual decision making about such complex issues is compounded by the collective irrationalities and inequities of the health-care system as a whole. We might agree that it is a crime for inner-city children to die because they do not have access to asthma inhalers, or for people without health insurance to have strokes because they cannot afford blood-pressure medication. But should providing those drugs take precedence over other strategies, such as reducing asthma triggers in substandard housing or raising the minimum wage to make low-income families less stressed-out? Would we have more money for preventive strategies if our health-care system were more equitable, and if other drugs, more clearly in the realm of luxuries—the pharmaceutical equivalent of SUVs—were not so heavily promoted as the treatment of choice for affluent consumers?
In short, confronting the hard reality that the seemingly endless pharmacological "supersizing" we have embarked upon is neither economically nor physiologically sustainable is incredibly hard. It some ways, it is easier to keep arguing about drug advertisements and their accuracy than it is to confront these overwhelming issues. So what are we to do? The list of possible political and regulatory options is very similar to the ones that reformers have been offering since the Kefauver days: reform of the drug patent system, stricter regulation of drug advertisements, and governmental control of drug prices. But none of these approaches appears to be politically viable at present, and will not be, I suspect, until we have the twenty-first-century version of the bubonic plague, the Great Depression, or the thalidomide tragedy. This leaves us with more-personal solutions. One can see why Americans tend to fall back on individual vigilance and morality politics: it is hard to find any other alternative.
In the meantime, let me express my own hope—strictly my personal opinion, not endorsed by the AAHM or the State University of New York—that the current gridlock may be preparing the ground for something truly new and different: namely, a greater ability for coalitions of patient-advocates and doctor-reformers to come together and explore their common political ground, a ground denied them in the past by specters of socialized medicine and the God-Doctor complex. If both sides forswore calling each dupes and morons, if they both accepted the
[End Page 662]
premise that progress requires everyone to give up some hard-fought rights, what might that movement look like? I will take the first step by saying that I personally will give up my right to listen to DTC advertisements; I am ready to let that particular American freedom go!
Pipe dreams? Perhaps—but being a Garrison Lecturer is a once-in-a-lifetime chance for a historian to dream. And I hope you, not only as historians but as citizens, patients, and doctors, will start to dream along with me.
Nancy Tomes is Professor of History at Stony Brook University, Stony Brook, New York 11794-4348 (e-mail: Nancy.Tomes@sunysb.edu). She is the author of A Generous Confidence: Thomas Story Kirkbride and the Art of Asylum-Keeping (Cambridge University Press, 1984), Madness in America: Medical and Cultural Perceptions of Mental Illness before 1914, co-authored with Lynn Gamwell (Cornell University Press, 1995), and The Gospel of Germs: Men, Women and the Microbe in American Life (Harvard University Press, 1998), winner of the 2002 Welch Medal. She is currently working on a book about the rise of the modern patient-consumer movement in the twentieth-century United States.
Footnotes
This is a revised version of the Fielding H. Garrison Lecture presented at the seventy-seventh annual meeting of the American Association for the History of Medicine in Madison, Wis., 30 April 2004. The research on which it is based has been supported by the Burroughs Wellcome Fund, the National Humanities Center, and the Robert Wood Johnson Foundation. I would like to thank the members of the History Department at Stony Brook University who commented on an early version of this paper presented in March 2004; Greg Higby, Ernest Hook, and Suzanne Junod White, for their suggestions regarding the version I presented at the AAHM meeting; and Greg Higby and Rima Apple, for their careful readings of the revised version. I would also like to thank Susan Strasser for sharing her work in progress on the medicine show, and Christopher C. Sellers and Philip A. Sellers for their overall help with the project.
The original lecture was illustrated with reproductions of historic drug advertisements. Copyright law requires that before reproducing these images in print form, I get permission to do so from the companies that produced them. All the pharmaceutical companies I asked for such permission refused my request, on the grounds that the lecture's content presents an unfavorable view of their industry. The reader interested in viewing these ads will have no difficulty locating them in library collections, where they can be found in the mass circulation magazines and daily newspapers read by millions of Americans. References to specific ads that I discuss in the lecture are given in my endnotes.
1.
H. J. Barnum, Jr., Creative Forum Paper #14, March 1967 (emphasis in the original), J. Walter Thompson Archives, Hartman Center for Sales, Advertising and Marketing History, Rare Book, Manuscript, and Special Collections Library, Duke University, Durham, N.C. (hereafter JWT). The cover memorandum from Bob Colwell, dated 30 March 1957, provides information about Barnum's background. I tried to determine whether Dr. Barnum was any relation to the nineteenth-century showman P. T. Barnum, also a resident of Connecticut: P. T. Barnum had daughters, not sons—so if there is a connection, it is not a direct one.
3.
David J. Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991).
4.
For a contemporary use of the term "pharmaceutical pitchmen," see Elizabeth Fried Ellen, "Visits from Pharmaceutical Reps," Psych. Times, January 2001, 18 : 1, http://www.psychiatrictimes.com/p010121.html (accessed 20 January 2005).
5.
Jason Pontin, "RX: Price Controls," Acumen J. Life Sci., 2003, 1 : 62–67, on p. 65.
6.
These statistics are taken from a summary of the IMS World Review 2004, a major industry source for pharmaceutical data, posted on the IMS website, http://www.ims- Global.com//insight/news_story/0403?news_story_040316.htm (accessed 20 January 2005). The IMS does not break down the $229.5 billion for the North American market into separate figures for the United States and Canada. To arrive at a figure for the United States, I subtracted the $15 billion reportedly spent in Canada: see Steve Morgan, "Sources of Variation in Provincial Drug Spending," Can. Med. Assoc. J., 2004, 170 (3): 329–30, statistic on p. 329. This figure is consistent with the estimates given in Marcia Angell, The Truth about the Drug Companies (New York: Random House, 2004), pp. 3–5.
7.
Using data for seven other developed nations made available to them by the Canadian government's Patented Medicines Price Review Board, Alan Sager and Deborah Socolar found that in 2002, U.S. brand-name drug prices were 77 percent above the average paid in those countries: see Alan Sager and Deborah Socolar, "Lower U.S. Prescription Drug Prices Are Vital to Both Patients and Drug Makers," Data Brief no. 3, Boston University School of Public Health, 24 July 2003, http://dcc2.bumc.bu.edu/hs/pdfs /Lower20drug20prices.pdf (accessed 20 January 2005).
8.
This figure comes from the Kaiser Family Foundation, "Prescription Drug Trends," October 2004, http://www.kff.org/rxdrugs (accessed 20 January 2005). The KFF estimate is based on the annual rankings of Fortune's top 500 companies, published in Fortune, 5 April 2004. See also Angell, Truth (n. 6), pp. 10–11.
9.
A study conducted by Families USA used the 2001 filings submitted by nine large drug companies to the Securities and Exchange Commission to compare the funds spent on research as opposed to marketing. The study found that all nine companies spent "considerably more" on marketing and advertising than they did on research and development: see Families USA, Profiting from Pain: Where Prescription Drug Dollars Go, Families USA Publication no. 02.105 (Washington, D.C.: Families USA Foundation, 2002), p. 9. The correlation between heavy direct-to-consumer advertising and growth in drug sales is documented in Steve Findlay, Prescription Drugs and Mass Media Advertising (Washington: National Institute for Health Care Management Research and Education Foundation, 2000). Although DTC advertising has provoked the most controversy, studies suggest that promotions aimed directly at physicians have a far greater effect on prescribing practices. See Ashley Wazana, "Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" JAMA, 2000, 283 : 373–80; the author reviewed 538 studies, 29 of them closely, and concluded that pharmaceutical company promotions had a significant effect on physicians' selection of medications. See also David Blumenthal, "Doctors and Drug Companies," New England J. Med., 2004, 351 : 1885–90.
10.
National Center for Health Statistics, Health, United States, 2004, with Chartbook on Trends in the Health of Americans (Hyattsville, Md.: NCHS, 2004), p. 14. Prescription drugs account for 10.5 percent of the total, compared to 31 percent for hospital expenditures and 32 percent for professional services.
11.
In recent years, a voluminous literature of criticism aimed at the pharmaceutical industry has appeared in article and book form. For a recent, thorough overview by a prominent critic of the industry and a former editor of the New England Journal of Medicine, see Angell, Truth about the Drug Companies (n. 6). Pontin emphasizes the importance of American resistance to price controls and national health insurance; he also cites 2003 testimony given to the Committee on Government Reform, U.S. House of Representatives, that "one-fifth of all Americans cannot afford to take at least some of the medicines their doctors have prescribed," and that among the poor and elderly, the figure is 40 percent (Pontin, "RX: Price Controls" [n. 5], p. 62). On the larger impact of income inequality on American health care, see Grace Budrys, Our Unsystematic Health Care System, 2nd ed. (Lanham, Md.: Rowman and Littlefield, 2005).
12.
On the global dimensions of drug-policy debates, see Arthur Daemmrich, Pharmacopolitics: Drug Regulation in the United States and Germany (Chapel Hill: University of North Carolina Press, 2004), pp. 1–3, 8–10; Giovanni Berlinguer, "Bioethics, Health and Inequality," Lancet, 2004, 364 : 1086–91. For international commentaries on American direct-to-consumer drug advertising, see Health Action International Europe, "Providing Prescription Medicine Information to Consumers: Is There a Role for Direct-To-Consumer Promotion?" Report of Symposium held on 10 January 2002 in Brussels, http://www.haiweb.org/campaign/DTCA/2002_symposium_report.pdf (accessed 29 January 2005).
13.
On the history of the 1938 act and the Durham-Humphrey amendment, see Harry M. Marks, "Revisiting 'The Origins of Compulsory Drug Prescriptions,'" Amer. J. Pub. Health, 1997, 85 : 109–15; John P. Swann, "FDA and the Practice of Pharmacy," Pharm. Hist., 1994, 36 : 55–70; Peter Temin, Taking Your Medicine: Drug Regulation in the United States (Cambridge: Harvard University Press, 1980); Charles O. Jackson, Food and Drug Legislation in the New Deal (Princeton: Princeton University Press, 1970).
14.
For background on the mid-twentieth-century pharmaceutical revolution, see Daemmrich, Pharmacopolitics (n. 12); Jonathan Liebenau, The Formation of the American Pharmaceutical Industry (Baltimore: Johns Hopkins University Press, 1987); Harry M. Marks, The Progress of Experiment: Science and Therapeutic Reform in the United States, 1900–1990 (New York: Cambridge University Press, 1997). An older but still useful history of prescription drugs is Harry F. Dowling, Medicines for Man: The Development, Regulation, and Use of Prescription Drugs (New York: Knopf, 1970).
15.
Milton Silverman and Philip R. Lee, Pills, Profits, and Politics (Berkeley: University of California Press, 1974), p. 22. While I have no doubt that the prescription drug revolution greatly changed medical practice, I think Silverman and Lee underestimate how important doctors' prescriptions were to patients in the pre-1950 era.
17.
Jeremy A. Greene, "Attention to 'Details': Etiquette and the Pharmaceutical Salesman in Postwar America," Soc. Stud. Sci., 2004, 34 : 271–92.
18.
The best history of the nineteenth-century proprietary medicine industry remains James Harvey Young, The Toadstool Millionaires: A Social History of Patent Medicines in America before Federal Regulation (Princeton: Princeton University Press, 1961). On its central role in the rise of professional advertising, see Jackson Lears, Fables of Abundance: A Cultural History of Advertising in America (New York: Basic Books, 1994), esp. pp. 88–99. On its importance to business methods more generally, see Pamela Laird, Advertising Progress: American Business and the Rise of Consumer Marketing (Baltimore: Johns Hopkins University Press, 1998). For a recent, penetrating critique of patent medicine and its marketing, see Susan Strasser, "Sponsorship and Snake Oil: Medicine Shows and Contemporary Public Culture," in Going Public: A Consideration of Public Culture in the United States, ed. Marguerite Shaffer (Philadelphia: University of Pennsylvania Press, forthcoming).
19.
The original FDA Act had to be amended in 1907 to give the agency the power to require that labels not contain any "false and fraudulent" statements—but this 1907 Sherley Amendment did not extend to promotions independent of the label, thus leaving the FDA with no power to regulate off-label drug advertising. During the New Deal debates over expanding their respective regulatory powers, the division of responsibility between the FDA and the FTC for oversight of advertising was hotly contested. On the 1938 debate, see Jackson, Food and Drug Legislation (n. 13), esp. pp. 116–25, 171–74. On the history of federal regulation of drug advertising, see David A. Kessler and Wayne L. Pines, "The Federal Regulation of Prescription Drug Advertising and Promotion," JAMA, 1990, 264 (18): 2409–25. In the United States, advertising has traditionally been regulated as a fair-trade practice, and since the 1970s, the courts have increasingly extended First Amendment protections to advertising as a form of commercial free speech. See Suzanne White Junod, "FDA and Commercial Free Speech: A New Regulatory World," Society for History in the Federal Government, Occasional Papers, 4 (Washington, D.C.: SHFG, 2004), pp. 41–53.
20.
On the history of market research, see Jean M. Converse, Survey Research in the United States: Roots and Emergence, 1890–1960 (Berkeley: University of California Press, 1987), pp. 87–127. The J. Walter Thompson Agency was particularly known for its use of market research as well as the science sell. See Stephen Fox, The Mirror Makers: A History of Advertising and Its Creators (New York: Morrow, 1984), pp. 79–101; Roland Marchand, Advertising the American Dream: Making Way for Modernity, 1920–1940 (Berkeley: University of California Press, 1985), esp. pp. 16–22.
21.
For a good overview of the medicine show and its influence on American culture, see Strasser, "Sponsorship and Snake Oil" (n. 18). On the traditional medicine show and its influence on early radio, see Ann Anderson, Snake Oil, Hustlers, and Hambones: The American Medicine Show (Jefferson, N.C.: McFarland, 2000); David Armstrong and Elizabeth Metzger Armstrong, The Great American Medicine Show (New York: Prentice Hall, 1991), chap. 18; Brooks McNamara, Step Right Up (Garden City, N.Y.: Doubleday, 1976).
22.
James Rorty, Our Master's Voice: Advertising (New York: Day, 1934), pp. 19, 394. On interwar intellectuals and their concerns about mass culture, see Brent Lenthall, "Critical Reception: Public Intellectuals Decry Depression-Era Radio, Mass Culture, and Modern America," in Radio Reader: Essays in the Cultural History of Radio, ed. Michele Hilmes and Jason Loviglio (New York: Routledge, 2002), pp. 41–62; Brett Gary, The Nervous Liberals: Propaganda Anxieties from World War I to the Cold War (New York: Columbia University Press, 1999). On the more specific ambivalence felt toward consumers, see Charles McGovern, "Sold American: Inventing the Consumer, 1890–1940" (Ph.D. diss.. Harvard University, 1993), esp. chaps. 2 and 6.
23.
The classic statement of advertising's limitations remains Michael Schudson, Advertising, the Uneasy Persuasion (New York: Basic Books, 1984). My research in the J. Walter Thompson Agency archives confirms Schudson's critique of the so-called hypodermic needle theory of advertising's effect, in that it reveals how often carefully crafted advertising campaigns failed to work as expected. For a good critique of scholars' tendency to oversimplify self-medication and the use of patent medicines, see Strasser, "Sponsorship and Snake Oil" (n. 18).
24.
"The Ballyhoo Institute and Medical Center," Ballyhoo, 1932, 3 (4): 26.
25.
"Ballyhoo's Mother Goose," Ballyhoo, 1932, 3 (5): back cover. The association between urban sophistication and disdain for advertising comes through clearly in Rorty, Our Master's Voice (n. 22).
26.
See James C. Whorton, Inner Hygiene: Constipation and the Pursuit of Health in Modern Society (New York: Oxford University Press, 2000); Rima Apple, Vitamania: Vitamins in American Culture (New Brunswick, N.J.: Rutgers University Press, 1996). As Apple's work shows, these tensions between physicians and proprietary medicine companies over advertising long predated the 1930s.
27.
The statistic on drug spending comes from Harold Aaron, Good Health and Bad Medicine (New York: McBride, 1940), p. vii. For an example of the subtle trade-off mentioned here, see the Phillips Milk of Magnesia advertisement, "He feared he had a serious disorder," published in a 1934 issue of the Saturday Evening Post, reproduced in Duke University Library, "Medicine and Madison Avenue," http://scriptorium.lib.duke.edu/dynaweb/mma/laxatives/Generic_BookTextView/542.
28.
Arthur Kallet and F. L. Schlink, 100 ,000,000 Guinea Pigs (New York: Grosset and Dunlap, 1933). On the interwar consumer movement, see Lawrence Glickman, "The Strike in the Temple of Culture," J. Amer. Hist., 2001, 88 : 99–128; McGovern, "Sold American" (n. 22); Norman Silber, Test and Protest: The Influence of Consumers Union (New York: Holmes and Meier, 1983).
29.
On therapeutic reform, see Marks, Progress (n. 14); John Harley Warner, The Therapeutic Perspective: Medical Practice, Knowledge, and Identity in America, 1820–1885 (Cambridge: Harvard University Press, 1986); Warner, Against the Spirit of System: The French Impulse in Nineteenth-Century American Medicine (Princeton: Princeton University Press, 1998). On the FTC exemption for advertising to physicians, see Silverman and Lee, Pills (n. 15), p. 49.
30.
Osler is quoted in Silverman and Lee, Pills (n. 15), p. 49.
31.
On interwar tensions between consumer advocates and medical leaders, see Nancy Tomes, "'An Undesired Necessity': The Commodification of Medical Service in the Interwar United States," in Commodifying Everything: Relationships of the Market, ed. Susan Strasser (New York: Routledge, 2003), esp. pp. 108–11. My discussion here is too limited to delve into the complexity of consumer politics in this period, but let me note that this category of "consumer activists" included individuals both outside and inside the federal government: for example, Stuart Chase, F. L. Schlink, and Arthur Kallet, who were involved in Consumers' Research and the Consumers Union, and Ruth Lamb and T. Swann Harding, who worked for the federal government (the FDA and the Agricultural Department, respectively). As my archival research has made evident, despite their shared interest in consumer protection, those affiliated with governmental regulatory agencies had few kind words for their peers in Consumers' Research or Consumers Union, who in turn distrusted them as agents of a federal bureaucracy too timid in its challenges to corporate influence. I will explore these tensions in the book-length version of my argument.
32.
"Report from Pfizer," New York Times, 31 March 1957, sect. 10, JWT. On the history of corporations' use of public relations, see Roland Marchand, Creating the Corporate Soul: The Rise of Public Relations and Corporate Imagery in American Big Business (Berkeley: University of California Press, 1998). Probably the most famous series of goodwill advertisements was Parke Davis's Great Moments in Medicine and Great Moments in Pharmacy series: see Jacalyn Duffin and Alison Li, "Great Moments: Parke, Davis and Company and the Creation of Medical Art," Isis, 1995, 86 : 1–29; Jonathan M. Metzl and Joel D. Howell, "Making History: Lessons from the Great Moments Series of Pharmaceutical Advertisements," Acad. Med., 2004, 79 : 1027–32.
33.
Greene, "Attention to 'Details'" (n. 17), p. 272.
34.
Ibid. The reference to detail men as "Santa Clauses" is reported in Richard Harris, The Real Voice (New York: Macmillan, 1964), p. 92.
35.
The postwar growth in prescription drugs accelerated a blurring of boundaries between the ethical and proprietary sectors of the pharmaceutical industry that had begun before World War II. See Dowling, Medicines for Man (n. 14), esp. pp. 80–86; Silverman and Lee, Pills (n. 15), esp. pp. 207–11. For a contemporary view of these developments, see "Drug Industry's Ethical-Proprietary Line Is Blurring," Oil, Paint and Drug Reporter, 3 September 1956, p. 5.
36.
Harry F. Dowling, "Twixt the Cup and the Lip," JAMA, 1957, 165 (6): 657–61, quote on p. 659.
38.
Vance Packard's three best-sellers were The Hidden Persuaders (New York: McKay, 1957), The Status Seekers (New York: McKay, 1959), and The Waste Makers (New York: McKay, 1960). Daniel Horowitz has argued that Packard's work had a profound influence on 1960s social criticism: see Daniel Horowitz, Vance Packard and American Social Criticism (Chapel Hill: University of North Carolina Press, 1994).
39.
Dale Console's testimony is quoted in Silverman and Lee, Pills (n. 15), p. 40.
40.
Louis Lasagna is quoted in U.S. Congress. Senate. Report of the Committee on the Judiciary, Subcommittee on Antitrust and Monopoly, Study of Administered Prices in the Drug Industry, 27 June 1961, 87th Congr., 1st sess., 1961, S. Doc. 448, p. 170. Vance Packard elaborated on the concept of "planned obsolescence" in The Waste Makers (n. 38).
41.
On the therapeutic cycle, see Mickey Smith, Small Comfort: A History of the Minor Tranquilizers (New York: Praeger Press, 1985), esp. pp. 4–7. For an excellent recent analysis of the history of psychoactive drugs, see Jonathan Metzl, Prozac on the Couch (Durham: Duke University Press, 2003). See also Susan L. Speaker, "From 'Happiness Pills' to 'National Nightmare': Changing Cultural Assessment of Minor Tranquillizers," J. Hist. Med., 1997, 52 : 338–76.
42.
Klerman introduced the term "pharmaceutical Calvinist" in Gerald Klerman, "Drugs and Social Values," Internat. J. Addict., 1970, 5 : 313–19.
43.
See Elizabeth Siegel Watkins, "'Doctor, Are You Trying to Kill Me?': Ambivalence about the Patient Package Insert for Estrogen," Bull. Hist. Med., 2002, 76 : 84–104.
44.
For a typical complaint that doctors prescribe drugs to get neurotic patients out of their offices, see Harris, Real Voice (n. 34), pp. 98–99. A similar argument can be found in Betty Friedan, The Feminine Mystique (New York: Norton, 1963). Susan L. Speaker, "Too Many Pills: Patients, Physicians, and the Myth of Overmedication in America, 1955–1980" (Ph.D. diss., University of Pennsylvania, 1992), provides a useful overview of the overmedication debates, and documents the growing tendency of the popular press to hold physicians accountable for overprescribing prescription drugs.
45.
The term "learned intermediary" was first used in a 1966 liability suit concerning the drug chloroquine phosphate. For an overview of its history, see Catherine A. Paytash, "The Learned Intermediary Doctrine and Patient Package Inserts: A Balanced Approach to Preventing Drug-Related Injury," Stanford Law Rev., 1999, 57 : 1343–76. The legal concept itself may have been articulated as early as the 1948 case Marcus v. Specific Pharmaceuticals, Inc., according to David J. Cooner, "The Intersection of Madison Avenue and the Learned Intermediary Doctrine," posted on Findlaw, http://library.findlaw.com/2003/Mar/7 /132622.html (accessed 29 January 2005). For an early characterization of physicians as a specialized subset of consumers, see Raymond A. Bauer, "Risk Handling in Drug Adoption: The Role of Company Preference," in Understanding Consumer Behavior, ed. Martin Grossack (Boston: Christopher, 1964), pp. 233–52.
46.
Consumers Union, The Medicine Show: Some Plain Truths about Popular Remedies for Common Ailments (New York: Simon and Schuster, 1961), p. 2.
49.
For a recent overview of the Kefauver hearings, see Philip J. Hilts, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation (New York: Knopf, 2003), esp. pp. 129–65. For a contemporary, and highly laudatory, account of Kefauver's drug work, see Harris, Real Voice (n. 34).
50.
Among the most influential journalistic critiques of the pharmaceutical industry were those by John Lear, "Taking the Miracle out of the Miracle Drugs," Sat. Rev., 1959, 42 : 35–41; and Morton Mintz, The Therapeutic Nightmare (Boston: Houghton Mifflin, 1965).
51.
Charles May, "Selling Drugs by 'Educating' Physicians," J Med. Educ., 1961, 36 : 1–23, quote on p. 1.
52.
Weinstein is quoted in U.S. Senate, Report (n. 40), p. 174. Charles May was thought to have suffered professionally for his critical stance toward the pharmaceutical industry: see Mintz, Therapeutic Nightmare (n. 50), pp. 182–84 (I thank Ernest Hook for bringing this point to my attention).
53.
Consumers Union, Medicine Show (n. 46), p. 184.
54.
Derrick Dunlop, "The British System of Drug Regulation," in Regulating New Drugs, ed. Richard L. Landau (Chicago: University of Chicago Press, 1973), pp. 229–37, quote on p. 237.
55.
While I am using the phrase "people's pharmacy" here to signify a new genre of consumer-friendly health advice, note that it is also the title of a popular book by Joe Graedon first published in 1976, as well as a syndicated newspaper advice column (written by Graedon in collaboration with his wife, Terry Graedon) and a call-in radio show (hosted by the Graedons). See Joe Graedon, The People's Pharmacy (New York: St. Martin's, 1976).
56.
Hilts, Protecting America's Health (n. 49), esp. pp. 166–77. Thalidomide was prescribed in Europe and Canada as a sedative, but when taken by pregnant women it resulted in the death or deformation of their fetuses; FDA official Frances Kelsey blocked the drug's approval in the United States, so there were only about forty thalidomide cases there, compared to at least eight thousand births in Europe: ibid., pp. 146–61.
57.
For an account of these battles from the FDA's point of view, see "Medical Advertising: State of the Craft and of Regulation: A Review of Events Leading to FDA's Regulatory Position in 1967," FDA Papers, 1967, 1 : 4–8. For general background on the 1960s and 1970s, see Hilts, Protecting America's Health (n. 49), esp. pp. 166–77.
58.
Seidenberg is quoted in Silverman and Lee, Pills (n. 15), p. 68.
60.
Speaker, "'Happiness Pills'" (n. 41). See also Speaker, "Too Many Pills" (n. 44). On the rise of a new kind of empowered patient-consumer advocacy in this period, see Nancy Tomes, "From Patient to Consumer: Why the History of Contested Terms Matters," in Public Health and Public Policy, ed. Rosemary Stevens, Charles E. Rosenberg, and Chester Burns (New Brunswick, N.J.: Rutgers University Press, forthcoming).
61.
The prototype of this new kind of consumer guide book, Consumers Union's The Medicine Show (n. 46), went through six editions between 1961 and 1989, and was soon joined by a host of imitators and competitors. The United States Pharmacopeial Convention, Inc., began to publish material for consumers in 1981, and to issue an annual volume titled Advice for the Patient in 1983.
62.
The Medical Letter was founded in 1958 by Arthur Kallet, one of Consumer Union's founders, and Harold Aaron, a physician long associated with CU. See "Who We Are," Medical Letter Web site, http://www.medletter.com/html/who.htm (accessed 14 February 2005).
63.
These generalizations are based on my reading of contemporary articles about the patient package insert (PPI). See, e.g., "When Patients Know What's Good for Them," AEI J. Gov. & Soc., 1981, 5 : 6–10.
64.
See Watkins's perceptive discussion on the PPI, "'Doctor, Are You Trying to Kill Me?'" (n. 43). For an overview of their history, see Howard M. Rowe, "Patient Package Inserts: The Proper Prescription?" Food Drug Cosmet. Law J., 1995, 50 : 95–124. The role of pharmacy's professional leaders and community pharmacists, in both the leaflet debate and patient education more generally, needs to be examined in greater detail. In a personal communication, Greg Higby noted that community pharmacists began to get involved in patient counseling in the 1970s, well before it was required by the 1990 Omnibus Budget Reconciliation Act and other legislation. Both professional leaders and retail pharmacists initially opposed the idea of leaflets, for different reasons: professional leaders felt the information should be given orally to patients, and retail pharmacists did not want the responsibility for distributing the leaflets. Opposition eased in the 1980s, when new computer systems made printing out the information easier, and pharmacists became more "comfortable," in Higby's words, with their role as patient counselors: Greg Higby, e-mail message to author, 22 February 2005.
65.
See Rowe, "Patient Package Inserts" (n. 64), pp. 114–16; Daniel H. Schluster, "FDA's Experience with Patient Package Inserts: A Program That Just Won't Go Away," http://leda.law.harvard.edu/leda7daW95/dschlust.html (accessed 17 June 2003).
66.
On consumer groups' opposition to DTC advertising in the 1980s, see Mark Novitch, "Direct-to-Consumer Advertising of Prescription Drugs," Food Drug Cosmet. Law J., 1984, 39 : 306–11, esp. pp. 309–10; James M. Johnstone, "Special Problems in Direct-to-Consumer Advertising of Prescription Drugs," ibid., 1987, 42 : 315–22, esp. pp. 317–18. Statistics on DTC spending are taken from Rich Thomaselli, "Code Red for DTC," Advertis. Age, 3 January 2005, p. 1.
67.
The history of evidence-based medicine is just beginning to be documented. See Ariel L. Zimerman, "Evidence-Based Medicine: On the Long History of a Recent Revolution" (Paper presented at the AAHM annual meeting, Madison, Wis., 2 May 2004). Perhaps the most influential example of evidence-based medicine is the Cochrane Collaboration, founded in 1993 and named in honor of the British epidemiologist Archie Cochrane. As explained on its Web site, the Cochrane Collaboration "produces and disseminates systematic reviews of health care interventions," which are prepared by Collaborative Review Groups, known colloquially as "Cochrane groups" (http ://www. cochrane. org).
68.
On industry funding of pharmaceutical research, see Angell, Truth (n. 6), esp. pp. 100–111.
69.
The PhRMA guidelines are currently posted at <b>http://phrma.org/publications /policy//2002-01.19.391.pdf. For an extended discussion of the guidelines, see Dana Katz, Arthur L. Caplan, and Jon F. Merz, "All Gifts Large and Small: Toward an Understanding of the Ethics of Pharmaceutical Industry Gift-Giving," Amer. J. Bioeth., 2003, 3 : 39–46, and the many commentaries it provoked, which appear on pp. 47–66.
71.
There is now an extensive literature on the impact of the pharmaceutical industry on medical practice. The reviews of Angell, The Truth About the Drug Companies (n. 6), provide a good sense of the range of opinions: see, e.g., David Rothman, "Strong Medicine," New Repub., 27 September 2004, p. 33; Elizabeth Whelan, "Junk-Science Reporting," Nat. Rev. Online, 8 September 2004, available via Lexus-Nexus Academic; "In Defense of the Drugmakers," Bus. Week Online, 14 September 2004.