A Historical Perspective of Pharmaceutical Promotion and Physician Education

The medical profession has recently awakened to a crisis over industrial influence in medical education. In recent years, the problem of industrial funding of continuing medical education (CME) has been the subject of stern warnings from academic medicine, prominent congressional hearings, and strict revisions of the Accreditation Council for Continuing Medical Education's Standards for Commercial Support. Commercial support for CME continues to increase and now comprises more than half of all CME income. These clear indicators of dependence have raised widespread concerns of bias in the ongoing education of practicing physicians regarding new drugs and failure of the medical profession to assume responsibility for educating physicians.¹

How did this come to be? Critics of the role of pharmaceutical promotion in medical education have claimed that policy changes in the 1980s altered relations between the medical profession and the pharmaceutical industry. However, in the late 1950s and early 1960s, divisions over the role of pharmaceutical marketing in physician education had already surfaced in the medical literature and in Congress. On closer analysis, the history of industry involvement in medical education involved tensions between promotion and education dating back to the origins of the wonder drugs, from antibiotics to antipsychotics.

To provide a better understanding of the present medical educational dependence on the pharmaceutical industry, this Commentary traces the problem of commercial influence on physician education from the advent of the wonder drugs through current concerns regarding formal CME, with particular attention to a critical period in the late 1950s and early 1960s during which most positions in the current debate were firmly established.

Between 1951 and 1961, 4562 new prescription products were brought to market, and analysts estimated that 70 cents of every dollar spent on drugs in 1961 went toward the purchase of drugs not available 10 years earlier.² This deluge of new pharmaceutical products in the postwar era visibly strained the ability of US physicians to remain current with newly available therapeutics. At the same time, increasing competitiveness in the pharmaceutical marketplace placed stronger emphasis on pharmaceuticals as brands, to be introduced to physicians through media ranging from journal advertising to direct mail to individual visits by pharmaceutical representatives. By 1960, Goodman and Gilman's classic textbook³ referred to this overflow of innovative compounds and promotional materials as the “therapeutic jungle.”

Following studies in the 1950s documenting that physicians consistently rated pharmaceutical sales representatives as the most important source in learning about new drugs, the role of commercial sources in physician education became a subject of research to market researchers, sociologists, psychologists, and the medical profession. These studies challenged the image of physicians as autonomous professionals insulated from the influence of marketing, and cataloged the nonrational bases of many prescribing decisions. As Ernst Dichter explained in a 1955 report to the Pharmaceutical Advertising Club of New York:

The physician expects himself to make up his own mind on the basis of objective evidence. And yet he finds himself confronted, like a housewife in a supermarket aisle, with a misery of choice which he tends generally to resolve by irrational and emotional factors.⁴

As evidence of the influence of pharmaceutical marketing over prescribing decisions mounted by the late 1950s, a cadre of academically based clinical investigators and educators began to clamor for corrective action. In a widely cited 1957 address, Harry Dowling (an active member of the American Medical Association's [AMA’s] Council on Drugs) argued that the increasing influence of pharmaceutical promotion on bewildered physicians prescribing worthless or redundant drugs constituted a moral crisis and a failure of the profession to uphold its duties of self-regulation of knowledge.⁵ Dowling's critique was joined by other prominent figures in the fields of infectious disease (who linked the problem of antibiotic misuse to exuberant pharmaceutical promotion) and clinical pharmacology (who sought to distinguish rational from irrational use of prescription drugs).

The response from industry was swift. Arthur Sackler, a psychiatrist and partner in the most prominent pharmaceutical advertising agency in the country, replied that physicians were fully able to read pharmaceutical marketing critically. “Pharmaceutical advertising,” he wrote, “has made one of the major contributions in the rapid dissemination of new therapeutic information.”⁶ The danger he portrayed was not deception or bias but a far more perilous communication gap; to Sackler, the corrective action was thus not for the pharmaceutical industry and its advertisers to tone down their rhetoric, but for the medical profession to keep pace in attracting the attention of its constituents.

The AMA's inability to address this problem during this period stemmed from internal schisms between those interested in strengthening the ties between organized medicine and the pharmaceutical industry, and those interested in promoting rational therapeutics. On the one hand, the AMA enjoyed an expanding income from pharmaceutical advertising after it disbanded the Seal of Acceptance program (which had required demonstration of efficacy by the AMA's Council on Pharmacy prior to permitting any drug to be advertised in JAMA) in 1955; on the other, the Council on Drugs continued to educate physicians regarding the risks and benefits of new therapeutic compounds.⁷ Implicitly, JAMA advertising and JAMA editorializing were to be seen as distinct entities. Nonetheless, with the profession unable to address the issue internally, the debate over promotion and education spilled out into the public sphere.

Although the Kefauver Hearings are often remembered for their outcome—the Kefauver-Harris Amendments of 1962, which mandated proof of efficacy prior to drug approval—Sen Estes Kefauver's (D, Tennessee) high-profile investigation of “Administered Prices in the Pharmaceutical Industry” (1959-1962) also focused attention on the form and content of general pharmaceutical marketing and the postgraduate pharmaceutical education of the nation's physicians.

Over the course of the hearings, therapeutic libertarians such as Austin Smith (president of the Pharmaceutical Manufacturers Association and former editor-in-chief of JAMA) argued for “competitive education” between the pharmaceutical industry and academia,⁸ while therapeutic reformers in academia warned that such an arrangement would result in the inevitable “brainwashing” of physicians. As the editor of Pediatrics, Charles D. May, warned in 1961:

A vicious cycle is created by a mad scramble for a share of the market: the doctor is made to feel he needs more “education” because of the prolific outpouring of strange brands but not really new drugs, produced for profit rather than to fill an essential purpose; and then the promoter offers to rescue him from confusion by a corresponding brand of “education.”⁹

Amidst such dissension, AMA representatives proposed a pragmatic compromise: so long as advertising standards were carefully guarded and physician education improved, promotion and education could exist as clearly separate spheres, each serving its own distinct purpose. This position would emerge from the Kefauver hearings as the prevailing descriptive and normative model to guide future action—and would ultimately come to be tested with respect to physician education.

In the aftermath of the Kefauver hearings, leaders in the AMA and academic medicine worked to establish formal CME as a professional control over physician education regarding pharmaceuticals, and CME requirements rapidly became tied to state licensing bodies. The increasing use of CME, however, also was accompanied by an increased interest in CME by the pharmaceutical industry. In 1963, a JAMA editorial declared of CME: “The principal source of financial support must come from within the medical profession. Financing often determines control, and control must remain in the hands of the profession.”¹⁰ However, investing in CME required funds that could not be borne out by tuition fees alone, and the pharmaceutical industry soon proved a willing partner in providing the ever-increasing budget for high-technology communications solutions to information transfer in CME.¹¹

Modern physicians, faced with the modern problem of information oversupply, demanded modern communications solutions, from radio to audiocassette to interactive telesymposia. Yet each new medium came with a significant price tag and found its most enthusiastic support among communications and public relations departments of pharmaceutical companies, at the same time that a growing market of medical education and communication companies emerged to produce CME content for pharmaceutical clients. Where the logic of separate spheres implied a firewall between the business and editorial functions of CME, ample evidence of the porousness of these firewalls existed as early as 1976, sufficient to prompt a series of hearings into the subject led by Sen Gaylord Nelson (D, Wisconsin).

Despite such hearings, the influence of medical education and communication companies continued to increase throughout the 1970s and 1980s. By the early 1990s, the subject emerged again in another set of hearings—now chaired by Sen Edward Kennedy (D, Massachusetts)—provoked by increasing reports of extravagant marketing practices by the pharmaceutical industry. The Kennedy hearings prompted a set of self-regulatory responses by the pharmaceutical industry and the medical profession under threat of governmental regulation.¹² The Accreditation Council for Continuing Medical Education, meanwhile, was prompted to issue Standards for Commercial Support on the limited and proper role of commercial interest in CME, which placed formal emphasis on firewalls to separate the business divisions of medical education and communication companies from their editorial divisions. Nonetheless, the standardization movement of the 1990s did little to stem the growth of the medical education and communication industry, and instead may have helped to legitimize and create a legal defense for the industry, which has increased steadily since that time.¹³

The problem of pharmaceutical promotion in the continuing education of practicing physicians presents an enduring dilemma. Arguments from academia, industry, and organized medicine articulated in 1958 persist in almost untouched form in 2008. Technological and regulatory solutions intended to defend professional control over knowledge circulation—such as CME—have instead provided novel sites of intersection between pharmaceutical marketing and physician education. At the same time, the stakes of the debate have continued to increase: by 2006, the worldwide sales of the pharmaceutical industry had increased to more than $600 billion, and estimates of the amount of money spent promoting new drugs to US physicians range from $27.7 billion to $57.5 billion.¹⁴

As advertising executive Pierre Garai noted in 1963: “The drug business is today, and will be tomorrow, what the doctors cause it to be. Drug advertising too.”¹⁵ Any responsible analysis of the role of pharmaceutical promotion in CME must account for the process by which individual physicians, organized medicine, and the regulatory state allowed and even encouraged this process to take place. Garai¹⁵ finished with the question: “We know what the doctors are today. What will they be tomorrow?” This question continues to define the important and precarious project of CME: a project with values, goals, and tools that remain very much at play between commercial and professional interests.