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Logo of nihpaAbout Author manuscriptsSubmit a manuscriptHHS Public Access; Author Manuscript; Accepted for publication in peer reviewed journal;
 
Am J Public Health. Author manuscript; available in PMC 2010 November 5.
Published in final edited form as:
PMCID: PMC2791253
NIHMSID: NIHMS241879

A Decade of Controversy: Balancing Policy with Evidence in the Regulation of Prescription Drug Advertising

Dominick L. Frosch, Ph.D., David Grande, M.D., M.P.A., Derjung M. Tarn, M.D., Ph.D., and Richard L. Kravitz, M.D., M.S.P.H.

Abstract

Prescription drug advertising to consumers (DTCA) has remained controversial since regulations were liberalized by the Food and Drug Administration in 1997. This paper reviews empirical evidence addressing the claims made in the policy debate for and against DTCA. We find that there are some benefits from DTCA, but significant risks are evident as well, magnified by the prominence of DTCA among population-level health communications. To minimize potential harm and maximize the benefits of DTCA for population health, we propose improving the quality and quantity of information to (1) enable consumers to better self-identify whether treatment is indicated, (2) enable consumers to more realistically appraise the benefits, and (3) enable consumers to better attend to the risks associated with prescription drugs.

The Food and Drug Administration (FDA) acquired jurisdiction over prescription drug advertising to consumers (DTCA) in 1962. For the next 35 years, television advertising was limited by a requirement that advertisements briefly summarize potential adverse reactions and contraindications to drugs. But in 1997 the FDA issued guidance specifying that “adequate provision” of information about drug risks and benefits could be made by referring consumers to a toll-free telephone number, a concurrent print ad, an internet website, or a physician, making it easier to advertise on television. The pharmaceutical industry dramatically increased its DTCA spending ($4.8 billion in 2007(1)) and shifted the majority of its budget from print to broadcast media(2;3).

The US practice of permitting DTCA is unique, with the single exception of New Zealand. Regulation of DTCA recognizes that prescription drugs differ from other consumer commodities because of their inherent risks; however commercial speech is nevertheless subject to significant protection under US law, leading legal scholars to conclude that a complete ban of DTCA is unlikely to withstand litigation testing its constitutionality(4-6). Policymakers revisited the issue of DTCA after the voluntary market withdrawal of Vioxx® (rofecoxib) in 2004, during the reauthorization of the FDA in 2007, and signs point to renewed interest in 2009(2;7). But legislators have struggled to reach consensus about the appropriate role of DTCA in the healthcare system. This polarized policy debate begs the question of which views have empirical support.

In effect, DTCA amounts to a large and expensive uncontrolled experiment in population health. In this article we identify the major claims made by proponents and opponents of DTCA and review findings from relevant empirical studies, with a focus on peer-reviewed literature. We conclude by proposing options for legislators to consider in balancing the constitutional protection of commercial speech with the need to protect the public's health.

Conceptual Framework

The role of patients in medical decision-making has changed in recent decades. Patients are no longer viewed as passive recipients of medical care, but instead as active participants who play a key role in making clinical decisions with their health care providers(8). The expansion of DTCA stems in part from these shifts in the conceptualization of the patient's role(2). Responding to critics, the pharmaceutical industry argues that DTCA plays an important role in enabling consumers to play an active role in medical decision-making. Our conceptual framework builds on this emerging role of consumers. As shown in Figure 1, exposure to prescription drug advertisements can prompt prescription requests. These requests, mediated or moderated by consumers' backgrounds (e.g. education and medical history), can be driven by ads that include insufficient, inaccurate or otherwise misleading information or alternately by ads that include sufficient, accurate and balanced information. By prompting requests for prescriptions, DTCA can promote patient participation in clinical decisions; however, depending on the quality of the information the downstream effects may be very different. If a request is clinically inappropriate, but physicians are unable (due to lack of knowledge, time or other background variables) or unwilling to correct the patient's perception, it may lead to unnecessary and potentially harmful prescribing. Alternately, if the request is appropriate, it may reduce under-prescribing and contribute to patient adherence. Exposure to ads may also have direct effects on adherence and medicalization, independent of promoting prescription requests by patients. Seeing ads may remind patients about their prescriptions or medical conditions, thereby potentially contributing to improved adherence. Ads may change perceptions about what constitutes a medically treatable condition, without necessarily leading to a prescription request. The debate over DTCA is mired in competing claims. In the following sections, we examine these claims in turn.

Figure 1
Conceptual model of the effects of prescription drug advertising

Are prescription drug advertisements educational?(9)

DTCA proponents justify the proliferation of ads by citing their educational potential. Surveys have queried physicians and patients about their perceptions of drug ads and studies have examined the content of print and television ads. More than half of physicians agree that DTCA educates patients about health conditions and available treatments(10-12). In surveys of the public, nearly three-quarters of respondents agree that ads improve their understanding of diseases and treatments(13) and more than 40% report using ad information in their decision-making process(14;15). But many physicians also believe that DTCA encourages patients to make unwarranted requests, while paradoxically promoting unnecessary fear of side-effects(11;12). And only a fraction of physicians (1.3%) and consumers (5.4%) feel that ads provide sufficient information about drug costs(16).

More objective content analysis studies of print and television ads find that most provide the indication for the product and describe some symptoms of the target condition(17-19). Significantly fewer ads provide information on the drug's mechanism of action, or prevalence, risk factors or causes of the condition(17-19). Less than one-third of ads provide information about alternative treatments or behavioral changes that could substitute for or complement medication(17-19). Drug benefit information is frequently described in vague qualitative terms or through the use of narratives that exaggerate their magnitude(18;20;21). Television ads spend significantly less time on a drug's risks than on its benefits. While risk information is typically provided in one continuous stream, benefit information tends to be interspersed throughout the ad(19;22). Only a minority of ads acknowledge variations in product effectiveness(22). The majority of ad content exceeds the 8th grade reading level recommended for the general public(23), potentially exacerbating health inequities. Between 1992 and 2002 educational content in print ads declined, while promotional content increased(24). Companies typically send supplemental materials about products to consumers requesting them through a toll-free telephone number. These more frequently contain information about drug mechanisms of action and supportive behaviors, but also often exceed the recommended 8th grade reading level(25). On product Internet sites, benefit information is frequently accessible on the first page, whereas accessing risk information typically requires several clicks and is often incomplete(26;27).

Consistent with these findings, one study that assessed consumer learning following ad exposure found that participants recalled more benefit than risk information(28). Two experimental studies suggest that providing the risk information at the end of an ad would increase recall(29;30). Another study that assessed rote learning found inaccurate recall of both benefit and risk information, suggesting that current ad formats may not promote accurate learning(31). In a series of experimental studies, the addition of a table containing quantitative benefit information reduced the magnitude of therapeutic benefit participants perceived relative to a standard print ad(32;33). Even participants with fewer years of formal education showed good understanding of tabular quantitative data(33).

In summary, while subjective surveys find that DTCA provides information that is valued by the public, there is insufficient evidence to conclude that ads are an effective educational vehicle. More objective content analytic studies consistently find that most ads emphasize benefits over risks and may be difficult for patients with average health literacy to understand. Several small studies suggest that immediate recall of information transmitted by ads in their current format is suboptimal. Rigorous experimental evidence indicates that exaggerated perceptions of benefit can be corrected with quantitative information not typically provided in current ads.

Do prescription drug advertisements improve the quality of clinical care?(34)

Studies examining the relationship between DTCA and the quality of medical care have queried whether patients exposed to DTCA have better discussions and relationships with their physicians. Surveys of physicians and patients suggest that DTCA promotes patient participation in their medical care(10;35;36), though it is unclear whether these subjective perceptions result from physician-patient discussions about advertised drugs(35). Patients report making better health decisions(15;37), seeking more information about current(14;36) and previously undiagnosed medical conditions(36;38), and having medication-related discussions with their physicians prompted by DTCA(14;15;36). In addition, most patients and physicians in nationally representative surveys agree that DTCA viewing gives patients more confidence to discuss health-related concerns with their physicians(11;13).However, a recent study found that medication requests were significantly less common among low SES patients, and ads promoting drugs for cardiovascular disease prevention were less likely to include ethnic minority characters or appear in magazines read by African Americans, potentially contributing to health inequities(39-42).

Evidence concerning the relationship between DTCA and the quality of physician-patient communication is mixed. The majority of physicians (67%)(12) and patients (54%)(15) report that DTCA positively affects physician-patient discussions and interactions, and most agree that DTCA can prompt important discussions(37;43). However, one study failed to show better or more medication-related discussions following DTC print ad exposure(44), and another indicated that few patients discover previously undiagnosed conditions as a result of DTCA viewing(45).

There is also conflicting evidence about how DTCA affects satisfaction with the physician-patient relationship. In nationally representative surveys, 39% of physicians and 30% of patients felt that DTCA interferes with the physician-patient relationship(11;13). An industry-funded survey of physicians found that most (82%) do not believe DTCA causes problems with their relationships with patients(45); however, in another survey 89% of family physicians did not feel that DTCA enhanced their relationships(10). Physicians are more annoyed when presented with a hypothetical medication request motivated by DTCA, versus a more traditional medical reference(46). Overall, physicians are less likely than patients to endorse the positive aspects of DTCA(16), and worry that DTCA promotes longer, unnecessary visits(11;16), and inappropriate medication requests(11;12). Patients may react negatively if their physician refuses a medication request. Nearly half of patients in one study reported feeling disappointed about not receiving a requested medication, one-quarter said they would try to change their physician's mind or get the drug elsewhere, and 15% considered terminating care with their physician(47).

Patients exposed to DTCA may obtain more appropriate pharmacologic treatments for their medical conditions. Surveys reveal that the majority of patients and physicians believe DTCA reduces under-prescribing(11;13). In a randomized controlled trial (RCT), 90% of standardized patients (actors) making a brand-name medication request received minimally acceptable initial care for depression, compared to 56% of those making no requests(48). In a quasi-experimental study of depressed patients, patients in areas with higher DTCA penetration were more likely to receive pharmacologic treatment(49). A survey found that half of the patients in a study requesting a medication for bladder problems were later diagnosed with the condition and prescribed the advertised drug(50). Women exposed to osteoporosis drug ads were more likely to receive bone density measurements(51).

In summary, there is some evidence that DTCA has the potential to improve the quality of care. Surveys find that it appears to encourage discussion of therapeutic options, and there is limited RCT evidence that it may ameliorate under-treatment of selected conditions. However, the overall effects of DTCA on doctor-patient communication are unclear, and the effects on quality of care appear mixed.

Do prescription drug advertisements promote patient adherence to prescribed regimens?(52)

Patient non-adherence costs approximately $100 billion annually in lost productivity and added health care expenditures(53). Proponents argue that DTCA increases patient adherence, however evidence remains scant.

In a representative survey, 72% of physicians agreed that ads promote patients' adherence to instructions(11). However, a majority of physicians (54%) in an industry-funded survey disagreed that they increase adherence(12). A nationally representative survey of the public found that 82% of respondents believed ads promote adherence to physicians' instructions(13), but among patients recruited from physicians' waiting rooms only 23% indicated they would be more likely to take an advertised drug(15).

Studies using claims data have examined the association between DTCA spending and persistence of prescribed medication regimens. Brand specific ads for anti-depressants had no effect on treatment duration, however, total ad spending for all anti-depressants showed a small but significant association with receiving treatment for at least 4 months(49). Similar small but significant prescription persistence effects have been found for cholesterol reducing statin drugs(54). High levels of DTCA for statins were also associated with patients reaching the least restrictive LDL goal recommended by clinical guidelines(55).

There is currently insufficient evidence to draw clear conclusions about the effects of DTCA on adherence to prescribed regimens. However, the available evidence suggests that DTCA may have small, beneficial effects on drug adherence.

Do prescription drug advertisements promote questionable prescribing practices?(56)

A chief concern of DTCA critics is its potential to increase inappropriate prescribing, reflecting both cost and safety concerns. Physician surveys find that DTCA increases prescription volume with evidence that some are clinically inappropriate. Eighty-one percent of physicians believe that DTCA prompts medication requests and a quarter report resulting changes in their prescribing habits(16). A survey of physicians and their patients found that 7% of patients made a prescription request and that DTCA exposure increased such requests(57). Though 78% of the requests were fulfilled, the prescribing physician judged half of these prescriptions as “possible” or “unlikely” choices for a “similar patient with the same condition.” In another survey, physicians judged half of DTCA-prompted requests to be clinically inappropriate(11). However, 69% of these requests were at least partially fulfilled, with a small but significant percentage (6%) judged as potentially harmful choices. Physicians often said they fulfilled such requests to accommodate patients(12).

More rigorous evidence measuring DTCA-prompted inappropriate prescribing comes from studies using claims data. Patients in a California HMO who reported exposure to ads for Cox-2 inhibitors were more likely to receive a Cox-2 inhibitor prescription than one for a non-steroidal anti-inflammatory drug(58). Using multiple measures of appropriateness, ad exposure significantly increased both appropriate and inappropriate Cox-2 prescribing. A study of a large cohort of private health plan patients found higher rates of proton pump inhibitor (PPI) switching to an advertised brand among patients living in television markets with high PPI DTCA volume(59). The therapeutic equivalence of PPIs raises questions about the appropriateness of these switches given that they generally increase treatment costs(60).

The most rigorous evidence assessing DTCA-prompted prescribing comes from a randomized experiment(48). Unannounced standardized patients (actors) making brand requests were the most likely to receive unwarranted prescriptions for adjustment disorder. However, these requests also increased the likelihood of appropriate prescriptions for major depression. In summary, the limited body of evidence suggests that DTCA-prompted prescription requests increase both appropriate and inappropriate prescribing. Whether the effects of DTCA are greater for appropriate or inappropriate prescribing remains unclear.

Do prescription drug advertisements promote overdiagnosis and medicalization?(61)

Critics of DTCA are concerned that it leads to medicalization, the process by which non-medical problems come to be defined as treatable medical illnesses, thereby potentially increasing unwarranted diagnoses(62). Critics argue that medicalization occurs as a result of mass marketing that “widens the boundaries of illness in order to expand markets” rather than improve population health(63). DTCA proponents argue that advertising helps address pervasive under-treatment(64).

Case studies of various marketing campaigns have examined the process and consequences of medicalization. For example, Paxil marketing campaigns for various anxiety disorders were found to advertise medicalized feelings of social discomfort with slogans such as “imagine being allergic to people”(62). Anti-depressant print ads have been found to use incomplete syllogisms leading readers to self-conclude that emotional symptoms are treatable using medications(65). A content analysis of advertisements found that DTCA often focuses on conditions that may not be recognized by consumers as pathologic or treatable(66). The only randomized experiment that provides some measure of medicalization found that adjustment disorder symptoms are more likely to be treated with medication when prompted by a DTCA-specific request(48). While it is clear that DTCA appears to medicalize symptoms previously not defined as illness, the question of whether a net social benefit exists is a complicated cultural and political question not easily answered through scientific studies.

Balancing evidence and regulatory policy

Table 1 provides a summary of the evidence supporting the claims made in the DTCA debate and identifies where further research is necessary. While there are some benefits from DTCA, significant risks are evident as well, magnified by the prominence of DTCA. Several changes in the content of ads could maximize their beneficial potential while minimizing their risks. Although adequate high quality information about prescription drugs is itself not sufficient to ensure appropriate prescribing decisions, it is a necessary ingredient to improve DTCA prompted prescribing. Table 2 lists guidelines proposed by the authors to improve the utility of DTCA in reducing inappropriate and increasing appropriate prescribing. Pharmaceutical companies could use data from advertisement pre-tests to demonstrate to the FDA that these issues have been addressed before an ad is aired to the public.

Table 1
Summary of evidence for claims made in support and opposition of DTCA
Table 2
Proposed content guidelines for prescription drug advertisements

Because pharmacological treatments are directed at patients with different medical conditions and varying educational needs to inform high quality decisions, our proposed guidelines distinguish between three categories: previously undiagnosed, asymptomatic conditions (e.g., hypercholesterolemia), previously undiagnosed symptomatic conditions (e.g., major depression), and previously diagnosed conditions (e.g., anemia). Depending on the condition more than one of these categories may be applicable in improving the advertisements' educational potential. In our view, there are three primary goals for DTCA. First, ads should facilitate the identification of appropriate patient candidates for treatment. At present, the majority of ads provide little information that would allow consumers to clearly identify whether the advertised product is indicated for them(18). Including the proposed information in ads could reduce inappropriate and increase appropriate prescribing. Second, ads should provide accurate and specific information about the potential benefits of advertised drugs instead of the current qualitative and emotionally driven portrayals that often suggest misleadingly dramatic effects. The inclusion of quantitative benefit data from clinical trials has been shown to lead to more realistic consumer appraisals of effectiveness, even among those with fewer years of formal education(32;33). Third, ads should provide specific quantitative information about the potential risks associated with drugs(67). Current ads often show a mismatch between visual imagery and verbal messages when risk information is presented. Research has shown that when visual and verbal messages are discordant, visual messages tend to dominate information processing, which could lead to inadequate processing of verbal risk information(68). All proposed information, including product risk information, should be provided at an 8th grade literacy level – to ensure comprehension by a larger segment of the population than is currently often the case(28). Consumers could also benefit from drug cost information, however there are currently no accurate means for comparing prices of different drugs(69). Until such data become available, ads could at minimum note, where applicable, that generic alternatives are cheaper.

We can anticipate some likely responses to our proposals. Some will argue that advertisements are too short (typically 1 minute) to include the information we propose. However, Pfizer has recently been running ads for Celebrex® (celexocib) that are 2.5 minutes long(70). Although it is unclear whether television viewers pay attention to longer ads, following our proposed guidelines may not require ads that are as long as the recent Pfizer ad. It is also important to note that our proposals are concerned with the quality as well as quantity of information.

Some will likely argue that the comparative benefit data we propose including in ads are often unavailable. While there are few direct comparative trials of different treatment options, both pharmacological and non-pharmacological, real-world decisions are also made in the absence of comparative trial data. Ads could communicate relevant data from trials that do not compare the options directly, but do provide some measure of what is known about the effectiveness of alternative treatment options. Data should be presented in a manner that increases accurate interpretation of the results by consumers(32;33;71).

Finally, critics of our proposals will contend that physicians are the learned intermediaries who should provide consumers with information about prescription drug indications, benefits and alternatives(72). This argument ignores well-documented realities of the American health care system. Recent data suggest that the average visit with a physician lasts between 16 and 21 minutes(73;74). If prescription requests are made by patients during consultations for other issues, this leaves little time for the physician to address misconceptions induced by DTCA. Moreover, the reliance of the current physician payment structure on satisfaction surveys introduces significant risks when denying patient requests. The negative impact of denying requests on the therapeutic relationship is well documented – patient satisfaction declines and physician switching increases(47) – although it may be possible to mitigate such effects by involving patients in the decision-making process(75).

It is unclear how the courts might rule on the proposed guidelines described in this paper if they were to be contested on First Amendment grounds (6). However, we believe the changes we propose are a win-win for both consumers and industry, perhaps reducing the likelihood that they would be challenged.

As noted, DTCA amounts to a large and expensive uncontrolled experiment in population health, which to date shows decidedly mixed effects. The evaluation of the effects of this experiment would be aided if the industry made the times when ads were aired in different media markets publicly available. Researchers could use these data to evaluate the effects of DTCA on drug expenditures and health outcomes with much greater precision, potentially benefiting both industry and regulators. Similarly, our proposed guidelines should also be subject to a trial period followed by careful evaluation, to ensure that changes in ad content have the intended beneficial effects on population health.

Following the market withdrawal of Vioxx® (rofecoxib), several pharmaceutical manufacturers announced a voluntary time-limited moratorium on advertising new products, though it is unclear if these have been implemented as initially announced(76). The industry should be given the opportunity to implement the changes proposed here on a voluntary basis. If these changes are not forthcoming, legislators will need to consider changing existing FDA regulations to ensure that DTCA achieves its full potential for maximizing population health.

Acknowledgments

Dr. Frosch is supported by a RWJF Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation, Princeton, New Jersey. Dr. Grande was supported in part by the RWJF Health & Society Scholars Program of the Robert Wood Johnson Foundation, Princeton, New Jersey. Dr. Tarn is supported by a UCLA Mentored Clinical Scientist Development Award (5K12AG001004) and by the UCLA Claude D. Pepper Older Americans Independence Center funded by the National Institute of Aging (5P30 AG028748). Dr. Kravitz is supported by a Mid-Career Research and Mentoring Award from the National Institute of Mental Health (K24MH072756).

Footnotes

Statement of Author Contributions

D.L. Frosch, D. Grande and D.M. Tarn completed the literature review. All authors participated in the writing of the manuscript.

Statement of Institutional Review Board Approval

No approval was required.

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