In this community-based randomized trial, antidepressants were prescribed far more often when SPs requested them. In addition, SPs portraying major depression and making either brand-specific or general requests were more likely than patients making no request to receive minimally acceptable initial depression care. These results underscore the idea that patients have substantial influence on physicians and can be active agents in the production of quality.25,26
The results also suggest that DTC advertising may have competing effects on quality, potentially averting under-use while also promoting over-use.
A simple model of DTC advertising holds that: a) ad exposure raises consumer awareness of conditions and treatments; b) increased awareness motivates patients to seek medical care and request drug therapy; and c) patients’ requests lead, ceteris paribus, to increased prescribing. Drug manufacturers endorse this model to the tune of $3.2 billion per year, but empirical evidence has been limited. Survey research suggests that advertisements raise consumer awareness and motivate patients to request prescriptions in up to 7% of primary care encounters.3,4,27–31
While not addressing the impact of DTC advertising on consumer awareness or care-seeking, our study supplies direct experimental evidence that DTC ad-driven requests (along with general requests) dramatically boost prescribing.
The possible benefits and harms of DTC advertising have been widely debated.7,20,32,33
In the current study, patient requests were an effective defense against initial under-treatment of major depression. Among SPs presenting with symptoms of frank depression but making no requests for medication, antidepressants were prescribed in just under one-third of SP visits and minimally acceptable initial care was rendered in 56%. While initial treatment may ultimately be less important than adequate follow-up (which affords opportunities to monitor outcomes and adjust treatment as necessary),34
these findings are consistent with other studies conducted in primary care settings.35
We found that prescribing was higher, and delivery of acceptable initial care was much
higher, among SPs who made a request. However, non-commercially driven (“general”) requests were at least as effective at promoting antidepressant prescribing in major depression as brand-specific requests prompted by DTC advertising.
Patient requests were also associated with a sharp rise in antidepressant prescribing for adjustment disorder. SPs randomized to portray this condition presented with insomnia and fatigue of short duration and with few signs of cognitive, somatic, social or functional impairment. Without prompting, physicians seeing these SPs were unlikely to prescribe an antidepressant, but prescription rates increased several fold following either a brand-specific or general request. Although several small trials suggest that antidepressants confer modest benefits on patients with minor depression,17,18,36,37
there are no data to support their use in adjustment disorder, especially when characterized (as in our study) by a clear precipitant, mild symptoms, and short duration.38
Thus, despite the wide therapeutic index of the second generation agents39,40
and the potential therapeutic value of acceding to patients’ reasonable requests,41
the use of antidepressants in this context is at the margins of clinical appropriateness.
Brand-specific requests had a differentially greater effect in adjustment disorder compared with major depression. This supports the hypothesis that DTC advertising may stimulate prescribing more for questionable than for clear indications. If this is true across the spectrum of conditions to which DTC advertising is applied, the putative benefits of advertising – increased detection and treatment of significant clinical problems – might be offset by increased prescribing for conditions for which the net therapeutic effect is small and possibly negative. Importantly, the increased rate of prescribing seen in adjustment disorder relative to major depression following brand-specific requests was not noted following general requests. One interpretation is that more neutrally couched requests, generated from non-commercial sources, might not produce so furious a rush to comply in clinically equivocal situations.
Given the likelihood that competing effects are not only possible but normative, the net social value of DTC advertising and the requests they engender may depend upon the specific clinical and epidemiological context. The benefits of advertising will tend to dominate when the target condition is serious and the treatment is very safe, effective, and inexpensive. Harms are most likely to emerge when the target condition is trivial and the treatment is relatively perilous, ineffective, or costly. From a legal perspective, these data pose a possible challenge to the “learned intermediary rule.”42
If patients can sway physicians to prescribe drugs they would otherwise not consider, physicians may not be the stalwart intermediary the law assumes.5
Standardized patients have been used in medical education, quality assessment, and increasingly in research.43–47
External validity of SP-based research might be threatened if: 1) SP roles are unrealistic or extreme; 2) SP portrayals are of poor quality; or 3) physicians “detect” the presence of an SP and act differently as a result. Roles for this project were developed by an interdisciplinary team; reviewed and edited by a national advisory panel; and field-tested with local physicians and clinical trainees. We trained and monitored SPs throughout the project. Our method for assessing detection was biased towards greater sensitivity than has been reported elsewhere in the literature,45
but even so, physicians were “suspicious” in only one visit out of eight, and 84% of physicians who reported suspicions claimed that they did not alter their usual clinical behavior (data not shown). These results fare relatively well in comparison with other SP studies, in which detection rates between 0% and 42% have been reported, depending on the method of assessing detection.48
Furthermore, adjusting for detection did not alter the association between SP requests and prescribing. Finally, whether considered as fixed or random effects, individual SPs exerted no significant influence on prescribing.
Several other limitations deserve mention. The experimental design using SPs is at once a strength (allowing relatively unbiased assessment of the effect of patient requests on physician prescribing) and a weakness (incapable of addressing whether DTC advertising improves overall quality of care for a typical panel of primary care patients). Further, we cannot determine whether DTC advertising actually produces the kinds of behaviors in real patients that were portrayed by our SPs. It is plausible that DTC advertising differentially “activates” patients with adjustment disorder compared to those with depression; such differential activation would nudge the risk/benefit ratio of DTC advertising in a negative direction. Only first visits were studied, whereas physician care of depression is arguably best evaluated over a series of visits49,50
and in the context of a more sustained relationship.51
The communities in which the study was conducted are highly penetrated by managed care; under- and over-prescribing might be even more prevalent than observed here in less organized settings. Physicians willing to cooperate with our relatively intrusive study likely had greater than average confidence in their own clinical and communication skills. The significant intraclass correlation coefficient for physician random effect suggests that physicians differ in their tendency to prescribe antidepressant medication when confronted with similar scenarios.
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. Further, physicians may require additional training to respond appropriately to patients’ requests in clinically ambiguous circumstances. Research in other clinical contexts is needed to confirm the results of this study and determine the relative effects of DTC advertising and non-commercial media on patient activation and outcomes.