"Spending on direct-to-consumer (DTC) advertising of prescription drugs in the United States totaled $3.2 billion in 2003," the authors provide as background information. "Critics charge that DTC advertisements lead to overprescribing of unnecessary, expensive, and potentially harmful medications, while proponents counter that they can serve a useful educational function and help avert underuse of effective treatments for conditions that may be poorly recognized, highly stigmatized, or both." The authors add that "antidepressant medications consistently rank among the top DTC advertising categories."
Richard L. Kravitz, M.D., M.S.P.H., from the University of California, Davis, and colleagues conducted a randomized trial using trained actors as standardized patients to determine the effects of patients' DTC-related requests on physicians' initial treatment decisions in patients with depressive symptoms. The patients were middle-aged, white, non-obese women, most with professional acting experience. They were trained to portray six roles. They were representing two clinical conditions: symptoms consistent with major depression or adjustment disorder, and three request types: a brand-specific drug request, a general drug request, or no request (control condition). The patients made appointments for office visits with 152 primary care physicians in Sacramento, Calif., San Francisco, and Rochester, N.Y., between May 2003 and May 2004. The scenarios included patients telling their doctor that they had seen an advertisement for Paxil on TV and asked for that drug by name; or patients saying they had watched a program on TV about depression and asking the physician if medication might help them. The researchers chose Paxil, a selective serotonin reuptake inhibitor antidepressant, because at the time of the study, it was widely promoted, priced higher than the generic fluoxetine, and available through the participating health care organizations in all three cities. In the control scenario, the patients reported the same symptoms but made no request for medication.
"Antidepressant prescribing rates were highest for visits in which standardized patients made general requests for medication (76 percent), lowest for visits in which standardized patients made no requests for medication (31 percent), and intermediate for visits in which standardized patients made brand-specific requests linked to DTC advertising (53 percent)," the authors found. "Among standardized patients portraying major depression, paroxetine was rarely prescribed (approximately 3 percent) unless the standardized patient specifically requested Paxil; if Paxil was requested by name, 14 (27 percent) of 51 received Paxil/paroxetine, 13 (26 percent) received an alternative antidepressant, and 24 (47 percent) received no antidepressant." For standardized patients portraying adjustment disorder, physicians were less likely to prescribe antidepressants. "There was a strong prescribing gradient according to request type: 55 percent of standardized patients making a brand-specific request received an antidepressant compared with 39 percent of standardized patients making a general request and 10 percent of those making no request. … Overall, physicians recommended primary care follow-up within two weeks for 33 (22 percent) of 149 standardized patients with symptoms of major depression and for 22 (15 percent) of 149 with adjustment disorder."
"These results underscore the idea that patients have substantial influence on physicians and can be active agents in the production of quality," the authors write. "The results also suggest that DTC advertising may have competing effects on quality, potentially averting underuse, while also promoting overuse."
The authors conclude: "The results of this trial sound a cautionary note for DTC advertising but also highlight opportunities for improving care of depression (and perhaps other chronic conditions) by using public media channels to expand patient involvement in care. Furthermore, physicians may require additional training to respond appropriately to patients' requests in clinically ambiguous circumstances."
(JAMA. 2005; 293:1995 – 2002. Available post-embargo at JAMA.com.) Editor's Note: This work was supported by a grant from the National Institute of Mental Health. Co-author Dr. Hinton received support from an NIA Career Development Award.
Editorial: A Haphazard Approach to Health Promotion
In an accompanying editorial, Matthew F. Hollon, M.D., M.P.H., from the University of Washington, Seattle, writes, "Relying on emotional appeals, most advertisements provide a minimal amount of health information, describe the benefits in vague, qualitative terms, and rarely offer evidence to support claims." He goes on to state, "More than 80 percent of physicians believe that DTCA does not provide balanced information."
"Kravitz et al take an important new step in DTCA research, presenting a cleverly designed randomized controlled trial that plumbs the impact of this marketing strategy. These investigators examined what happens when physicians in primary care clinical settings are faced with specific requests for drug therapy."
Hollon writes that it is unlikely that the federal government will restrict direct-to-consumer advertising. He provides his suggestions for improving the messages to consumers: "… at a minimum, the FDA should expect that pharmaceutical companies improve the educational nature of DTCA by further developing and adhering to appropriate standards to facilitate regulatory efforts. In addition, the FDA should be adequately funded to accomplish its regulatory function. Last, because the safety of a new drug cannot be known with certainty until it has been on the market for several years, and since drug withdrawals occur more than two thirds of the time within three years of release, the FDA should consider a moratorium on advertisement of drugs directly to consumers for three years after initial market release."
(JAMA. 2005; 293: 2030-2033. Available post-embargo at JAMA.com)
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JAMA