Robert A. Bell, PhD

The appropriateness of direct-to-consumer (DTC) prescription drug advertising has been a topic of heated discussion in recent years.^1,2 This debate is likely to intensify as the drug industry’s advertising expenditures continue to increase^3,4 and the marketing channels employed expand to include television, which may not lend itself to highly informative messages, and the Internet, which is difficult to regulate.⁵ Ironically, DTC advertising proponents and opponents have most often based their positions on assumptions about the informational value of such promotions.⁶ However, empirical data on this issue are sparse.

The opponents of DTC advertising argue that the objectives of drug promotion and health education are inherently at odds.⁷ It has been noted that the aim of DTC advertising is to increase sales, not optimize health care.^8,9 It has been presumed that the profit motive discourages the provision of complete and accurate information about pharmaceuticals.¹⁰ Reports have documented violations of the public trust¹¹ and the dissemination of misleading information to health care professionals.^12,13 If even highly trained physicians are prone to influence by commercial rather than scientific sources of pharmaceutical information,¹⁴ how can consumers protect themselves from misleading claims? To make matters worse, the public may be ill equipped to fully understand such advertising, no matter how accurate its content might be.^7,15

Defenders of DTC advertising counter these arguments by suggesting that selling and educating are not necessarily incompatible goals¹⁶ and that it is in the industry’s self-interest to be truthful with consumers.¹⁷ Although instances of misleading DTC advertising can be identified, such cases are said to be rare.⁵ Proponents of DTC advertising typically attribute greater sophistication to the public than critics do,¹⁶ rejecting the notion that consumers cannot comprehend such advertising.¹⁸ In any regard, misunderstandings can be corrected by the physician, in whom the power to prescribe ultimately resides.¹ Although many physicians oppose DTC advertising, a majority feel that such advertisements might help patients become better informed about drugs,¹⁹ conjecture that has empirical support.²⁰

We have attempted to contribute to the debate on the value of DTC advertising by describing its content. In a recent JFP article,²¹ we documented the types of appeals and inducements used in these promotions. In this article we describe the scope of the educational efforts represented in advertisements appearing in consumer publications from 1989 through 1998. After identifying basic issues that most DTC advertisements should address to have educational merit, we examined the extent to which such promotions provide consumers with information about medical conditions, including their symptoms, precursors, and prevalence. It has been argued that DTC advertising increases the public’s awareness of these aspects of diseases and other health conditions. This kind of patient education is said to help people to take responsibility for their health by teaching them how to recognize disease and motivating them to seek medical attention for conditions that might otherwise be left undiagnosed and untreated.^1,22-24

We then examined the extent to which DTC advertising incorporates information about treatments for those conditions. It has been said that consumer-targeted prescription drug advertising provides the public with valuable information about available treatments that leads to a better match between patients’ needs and available drugs.²⁵ Specifically, we examined the extent to which DTC advertising offers details about promoted drugs’ mechanisms of action, the duration and success of advertised treatments, behavioral modifications that can improve the patient’s health independently or in concert with drug treatment, and competing treatments.

Methods

Sampling Procedure

Major popular magazines were ranked in terms of the average number of advertising pages sold from 1989 through 1996 (the last year for which data were available) and then grouped into an established set of categories.²⁶ The highest-ranked publication within each of 13 categories was selected for inclusion in our sample. To these magazines we added 5 publications with audiences composed of narrower segments of our population defined by ethnicity, age, and sexual orientation. Thus, we garnered our sample of advertisements from 18 diverse publications Table 1. All the advertisements promoting a specific, named prescription drug that appeared in these magazines from January 1989 through December 1998 were photocopied. Advertisements for the same brand often differed in nonsubstantive ways and were thus coded as a single case based on detailed rules that are available from the authors. After aggregating essentially identical advertisements, 320 remained for analysis covering 101 distinct brands.

Medical Conditions Classification

Each advertisement was grouped in one of 14 medical condition categories based on the indication of the marketed drug. The numbers of advertisements and brands within each of these categories were as follows: allergies (46 advertisements, 8 brands); cancer (2, 2); cardiovascular disease (36, 10); dermatologic conditions (37, 12); diabetes (9, 4); gastrointestinal/nutritional disorders (17, 7); human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS; 33, 11); infections, non-HIV (16, 6); musculoskeletal disorders (17, 7); obstetric/gynecologic conditions (45, 10); psychiatric/neurologic disorders (17, 7); respiratory disorders (3, 3); tobacco addiction (23, 6); and urologic conditions (19, 8).

Advertisement Coding

Two coders independently analyzed each advertisement. Our goal for this classification effort was to determine whether each advertisement contained 5 kinds of information pertaining to the focal medical condition and 6 types of drug treatment information Table 2.

Statistical Analyses

We examined each of the 11 education codes listed in Table 2 and computed 3 more general measures. We created a condition information index by summing the number of medical condition codes present within each advertisement (theoretical range=0-5). Likewise, a treatment information index was computed by summing the number of treatment codes present within each advertisement (theoretical range=0-6). A combined education index was created by adding the condition and treatment information variables (theoretical range=0-11).

The reliability of coding was assessed with the k statistic, a measure of inter-rater agreement with a range of 0 to 1.0.²⁷ The mean k value for the variables reported was 0.91 (range=0.88-1.0). Landis and Koch²⁸ suggest that k values in this range can be considered “almost perfect.”

We employed 2 units of analyses. For our descriptive analyses, the advertisement served as the unit of analysis (N=320). We relied on the brand (N=101) as the unit of analysis when computing cross-tabulations and one-way analyses of variance. Using the advertisement as the unit for inferential statistical analyses would have violated the assumption of independence of observations,²⁹ because most advertisements for a particular brand represent alterations of earlier promotions for that brand. The advertisements for each brand were aggregated into a single case by weighting; each advertisement was assigned a weight of 1/n, with n representing the number of advertisements for that brand. When a significant chi-square value was obtained for a cross-tabulation, the source of significance within the table was determined by examining the cell-adjusted standardized residuals using a P <.05 criterion.³⁰

Results

The Figure shows the percentage of advertisements for which the 5 medical condition information codes and 6 treatment information codes were present. These results have been ordered in the Figure on the basis of frequency of occurrence.

Information About Medical Conditions

The medical condition name was provided in virtually all of the advertisements (95%). This information was excluded in 1 “teaser ad” that simply showed a bottle of tablets for a forthcoming treatment, in 7 advertisements alerting patients of a new formulation of a drug already prescribed for them, and in 9 advertisements notifying patients of an alternative delivery system for an established treatment. Sixty percent of the advertisements described at least one symptom of the condition treated by the promoted drug or explicitly stated that the condition could be a “silent disease”. Among those advertisements that omitted symptom information, 54% were targeted to individuals who had already been diagnosed with the condition and were presumably aware of its symptoms. The remaining advertisements tended to be for conditions with well-known symptoms (eg, pregnancy, impotence, and tobacco addiction). Information about a precursor to the condition such as a cause or risk factor was provided in 27% of the advertisements. A total of 6% of advertisements provided precursor information by means of a set of diagnostic questions, such as a quiz that readers could use to assess their risk of being or becoming affected by the condition (data not diagramed). Information about condition prevalence (12% of advertisements) and clarifications about a condition-related misconception (9%) was rarely provided.

Information About Treatments

The Figure also displays the percentage of advertisements reporting each of the 6 types of treatment information. Most often present was information about a drug’s mechanism of action, found in 36% of the advertisements. An acknowledgement of the existence of one or more competing treatments was offered in 29% of the advertisements. Supportive behaviors such as changes in diet, physical activity, and sleeping patterns were reported in 24% of the advertisements. In our judgment, relevant supportive behaviors are often recommended by physicians for most of the conditions addressed in these advertisements. Readers were given information about time to onset of action in 20% of the advertisements and typical required treatment duration in 11%. A success rate estimate was rarely reported (9%).

Three of these treatment information codes were significantly associated with the medical conditions variable (all P values=.02). Supportive behaviors that could be used alone or to enhance the effectiveness of therapy were more likely to be found in diabetes and tobacco cessation treatments (75% and 67% of brands, respectively). Time to onset of action information was especially likely to be offered in advertisements for dermatological and urological problems (58% and 50%, respectively). Information about treatment duration was most often found in advertisements for infection and dermatological treatments (50% and 33%, respectively).

Indexes

For summative purposes we examined the condition information, treatment information, and overall education indexes for each of the 14 medical condition categories, using the drug brand as the unit of analysis. The average brand provided only 2.1 of the 5 types of information about the condition for which the drug was marketed. Only 1.2 of the 6 types of treatment information we coded was provided in the average brand-weighted advertisement. Summing across the condition and treatment information variables, the average number of educational codes present for these 101 brands was only 3.2 out of a possible score of 11 (range=1.0-7.3).

Next we categorized the brands under the medical condition category for which each was promoted Table 3. Despite weak statistical power, a significant difference across the 14 medical conditions was found for 2 of the 3 indexes, the condition information index (F [13,87]=3.05, P=.001) and the combined education index (F [13,87]=2.39, P=.008). On the basis of post hoc comparisons, both effects could be attributed to the greater provision of information in promotions for urologic brands than in HIV/AIDS brand advertisements.

Information Formats

Information about conditions and treatments was typically provided in narrative form. Tabular data or charts (eg, bar, pie, or column charts) were rarely used to provide information about the drug (2% of advertisements) or the medical condition (<1%). Diagrams and pictures were also rarely used to provide information about the effectiveness of the treatment (2% of advertisements) or the nature of the condition (7%).

Other Sources of Information

One view of DTC advertising is that it simply provides an introduction to a treatment and that more detailed patient education is best provided in other ways, such as with brochures and videotaped presentations or through the Internet. An explicit offer of printed or audiovisual information was provided in 35% of the advertisements, and a toll-free information telephone number was found in 73%. Increasingly, the Internet is being used as a means through which interested readers can obtain more information about advertised products. In 1996, 1997, and 1998, the percentages of advertisements that provided a Web site address were 14%, 33%, and 57%, respectively. Most telephone numbers were numeric (55%), but some of these and all Web addresses referenced a benefit of use (eg, 1-800-5-SHUT-EYE for a treatment of insomnia), the treated body part (eg, www.kidsears.com for a treatment of ear infections), the medical condition treated (eg, 1-800-66-ANGINA), the brand name of the drug (eg, www.atrovent.com), or the drug company’s name (eg, 1-800-GLAXO-RX).

Discussion

A time may come when DTC advertising is recommended for its educational value, but that day is not yet at hand. The advertisements that have appeared during the past decade have been superficial in their coverage of medical conditions and their treatments. Although most provide the name of the treated medical condition and its associated symptoms, the large majority do not inform potential patients about such basic matters as the risk factors for the condition or its prevalence. Likewise, these advertisements seldom educate patients about the mechanism of action by which the drug treats a particular condition, its success in doing so, alternative treatments, and behavioral changes that could augment or supplant treatment. To their credit, most of these promotions do offer the reader alternative ways of learning more about their condition and the advertised drug.

The medical community should exert pressure on the drug industry to incorporate more information about conditions and treatments in its advertising. It is in the industry’s best interest to do so. Advertising that incorporates quality health and drug information will have greater credibility, and deservedly so. Also, consumers are less likely to be influenced by messages that appear to be more promotional than informational.³¹ Thus, providing complete and accurate information is the right thing to do and may even enhance the effectiveness of DTC advertising. If such information is not provided voluntarily by the industry in future advertising, the medical establishment should lobby for regulation.

These results also highlight an important opportunity for professional organizations to contribute to consumer education on prescription drugs. According to the National Institute for Health Care Management, the most successfully promoted drugs fall into 5 categories: antidepressants, cholesterol-lowering agents, gastric acid reducers, oral antihistamines, and antihypertensives.³² Organizations such as the American Academy of Family Physicians and the American College of Physicians already produce patient informational materials, but these efforts could be intensified so physicians would have a ready source of “counter-detailing.” Patients requesting drugs for which the indications are questionable could be given a handout and told, “This is what my professional society has to say about _________. This information is produced by the best experts in the field and provides a more balanced view than what you will find in profit-motivated advertisements. Look it over, and let’s talk about this at our next visit.”

If the industry were to be prodded into taking a more educational stance in its consumer-targeted prescription drug advertising, the impact of this shift on physician-patient interactions would need to be investigated. A more educated patient may take less time to treat and counsel, might show greater adherence to treatment regimens, and could assume greater responsibility for his or her health. On the other hand, educational promotions may lead to requests from more determined patients for drugs that are not medically indicated, requiring time-consuming re-education by their physicians.

Limitations

Our study has limitations. We have evaluated the educational qualities of these advertisements by imposing a common set of standards for each promotion. A stronger approach would have been to convene a panel of experts for each of the many conditions treated by the promoted drugs to identify the specific details that consumers need to know about the condition and its treatment. Resource constraints prevented us from developing expert-based educational standards for each condition or disease. However, it is reasonable to expect the drug industry to provide to consumers basic information about the treatments being promoted and the conditions these drugs address. We acknowledge that particular content analytic codes may have been irrelevant to certain conditions. For instance, precursor information does not need to be provided when the causes of the condition are obvious (eg, advertisements for contraceptive drugs); mention of supportive lifestyle changes should not be demanded when helpful behavioral changes do not exist (eg, advertisements for hair loss treatments); and references to the presence of competing treatments should not be expected in the rare event that such treatments are nonexistent. Such exceptions aside, we believe that the 11 codes assessed are both fundamental and relevant to the vast majority of the conditions covered by these advertisements.

Also, with this preliminary investigation we sought only to assess the extent to which the industry is making an effort to provide information about medical conditions and treatments for those conditions. We did not examine the educational quality of these efforts, including the completeness and accuracy of information provided about conditions and treatments. Such assessments will require input from medical and pharmaceutical experts selected for their specialized knowledge.

Conclusions

We acknowledge that instances of informative advertising can readily be found in our sample of advertisements. Thus, although DTC advertising in general is not serving the information needs of consumers, there are companies and individuals within the industry who are motivated to treat their advertising as vehicles for effective health promotion through quality education. Billions of dollars will be spent in the next few years on consumer-targeted prescription drug promotions.⁴ Consumers will be very receptive to those advertisements that address their personal health needs and concerns³³; many will talk to their primary care physicians as a result of these promotions.³⁴ The drug industry thus has a tremendous opportunity to silence its critics and improve the public’s health by providing objective medical and drug information.³⁵

Acknowledgments

We wish to acknowledge the contributions made by Ronald Emerick, Robert LaGreca, Love Lord, and Sarah Shaw in the collection and coding of advertisements and by 2 anonymous peer reviewers for their thoughtful evaluations.

Related Resources:

• U.S. Food & Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising and Communications www.fda.gov/cder/ddmac/
• Public Citizen Health Research Group “Drugs” page, listing numerous government documents that describe recommendations for drug use, sales and marketing. http://www.citizen.org/hrg/publications/drugs.htm
• AARP Executive Summary: Are Consumers Well Informed About Prescription Drugs? The Impact of Printed Direct-to-Consumer Advertising http://research.aarp.org/health/2000_04_advertising_1.html
• drkoop.com-Perspective: ‘Direct-to-Consumer’ Advertising of Prescription Drugs is More Harmful than Helpful to Consumers www.drkoop.com/news/focus/november/dtc_no.html

The appropriateness of direct-to-consumer (DTC) prescription drug advertising has been a topic of heated discussion in recent years.^1,2 This debate is likely to intensify as the drug industry’s advertising expenditures continue to increase^3,4 and the marketing channels employed expand to include television, which may not lend itself to highly informative messages, and the Internet, which is difficult to regulate.⁵ Ironically, DTC advertising proponents and opponents have most often based their positions on assumptions about the informational value of such promotions.⁶ However, empirical data on this issue are sparse.

The opponents of DTC advertising argue that the objectives of drug promotion and health education are inherently at odds.⁷ It has been noted that the aim of DTC advertising is to increase sales, not optimize health care.^8,9 It has been presumed that the profit motive discourages the provision of complete and accurate information about pharmaceuticals.¹⁰ Reports have documented violations of the public trust¹¹ and the dissemination of misleading information to health care professionals.^12,13 If even highly trained physicians are prone to influence by commercial rather than scientific sources of pharmaceutical information,¹⁴ how can consumers protect themselves from misleading claims? To make matters worse, the public may be ill equipped to fully understand such advertising, no matter how accurate its content might be.^7,15

Defenders of DTC advertising counter these arguments by suggesting that selling and educating are not necessarily incompatible goals¹⁶ and that it is in the industry’s self-interest to be truthful with consumers.¹⁷ Although instances of misleading DTC advertising can be identified, such cases are said to be rare.⁵ Proponents of DTC advertising typically attribute greater sophistication to the public than critics do,¹⁶ rejecting the notion that consumers cannot comprehend such advertising.¹⁸ In any regard, misunderstandings can be corrected by the physician, in whom the power to prescribe ultimately resides.¹ Although many physicians oppose DTC advertising, a majority feel that such advertisements might help patients become better informed about drugs,¹⁹ conjecture that has empirical support.²⁰

We have attempted to contribute to the debate on the value of DTC advertising by describing its content. In a recent JFP article,²¹ we documented the types of appeals and inducements used in these promotions. In this article we describe the scope of the educational efforts represented in advertisements appearing in consumer publications from 1989 through 1998. After identifying basic issues that most DTC advertisements should address to have educational merit, we examined the extent to which such promotions provide consumers with information about medical conditions, including their symptoms, precursors, and prevalence. It has been argued that DTC advertising increases the public’s awareness of these aspects of diseases and other health conditions. This kind of patient education is said to help people to take responsibility for their health by teaching them how to recognize disease and motivating them to seek medical attention for conditions that might otherwise be left undiagnosed and untreated.^1,22-24

We then examined the extent to which DTC advertising incorporates information about treatments for those conditions. It has been said that consumer-targeted prescription drug advertising provides the public with valuable information about available treatments that leads to a better match between patients’ needs and available drugs.²⁵ Specifically, we examined the extent to which DTC advertising offers details about promoted drugs’ mechanisms of action, the duration and success of advertised treatments, behavioral modifications that can improve the patient’s health independently or in concert with drug treatment, and competing treatments.

Methods

Sampling Procedure

Major popular magazines were ranked in terms of the average number of advertising pages sold from 1989 through 1996 (the last year for which data were available) and then grouped into an established set of categories.²⁶ The highest-ranked publication within each of 13 categories was selected for inclusion in our sample. To these magazines we added 5 publications with audiences composed of narrower segments of our population defined by ethnicity, age, and sexual orientation. Thus, we garnered our sample of advertisements from 18 diverse publications Table 1. All the advertisements promoting a specific, named prescription drug that appeared in these magazines from January 1989 through December 1998 were photocopied. Advertisements for the same brand often differed in nonsubstantive ways and were thus coded as a single case based on detailed rules that are available from the authors. After aggregating essentially identical advertisements, 320 remained for analysis covering 101 distinct brands.

Medical Conditions Classification

Each advertisement was grouped in one of 14 medical condition categories based on the indication of the marketed drug. The numbers of advertisements and brands within each of these categories were as follows: allergies (46 advertisements, 8 brands); cancer (2, 2); cardiovascular disease (36, 10); dermatologic conditions (37, 12); diabetes (9, 4); gastrointestinal/nutritional disorders (17, 7); human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS; 33, 11); infections, non-HIV (16, 6); musculoskeletal disorders (17, 7); obstetric/gynecologic conditions (45, 10); psychiatric/neurologic disorders (17, 7); respiratory disorders (3, 3); tobacco addiction (23, 6); and urologic conditions (19, 8).

Advertisement Coding

Two coders independently analyzed each advertisement. Our goal for this classification effort was to determine whether each advertisement contained 5 kinds of information pertaining to the focal medical condition and 6 types of drug treatment information Table 2.

Statistical Analyses

We examined each of the 11 education codes listed in Table 2 and computed 3 more general measures. We created a condition information index by summing the number of medical condition codes present within each advertisement (theoretical range=0-5). Likewise, a treatment information index was computed by summing the number of treatment codes present within each advertisement (theoretical range=0-6). A combined education index was created by adding the condition and treatment information variables (theoretical range=0-11).

The reliability of coding was assessed with the k statistic, a measure of inter-rater agreement with a range of 0 to 1.0.²⁷ The mean k value for the variables reported was 0.91 (range=0.88-1.0). Landis and Koch²⁸ suggest that k values in this range can be considered “almost perfect.”

We employed 2 units of analyses. For our descriptive analyses, the advertisement served as the unit of analysis (N=320). We relied on the brand (N=101) as the unit of analysis when computing cross-tabulations and one-way analyses of variance. Using the advertisement as the unit for inferential statistical analyses would have violated the assumption of independence of observations,²⁹ because most advertisements for a particular brand represent alterations of earlier promotions for that brand. The advertisements for each brand were aggregated into a single case by weighting; each advertisement was assigned a weight of 1/n, with n representing the number of advertisements for that brand. When a significant chi-square value was obtained for a cross-tabulation, the source of significance within the table was determined by examining the cell-adjusted standardized residuals using a P <.05 criterion.³⁰

Results

The Figure shows the percentage of advertisements for which the 5 medical condition information codes and 6 treatment information codes were present. These results have been ordered in the Figure on the basis of frequency of occurrence.

Information About Medical Conditions

The medical condition name was provided in virtually all of the advertisements (95%). This information was excluded in 1 “teaser ad” that simply showed a bottle of tablets for a forthcoming treatment, in 7 advertisements alerting patients of a new formulation of a drug already prescribed for them, and in 9 advertisements notifying patients of an alternative delivery system for an established treatment. Sixty percent of the advertisements described at least one symptom of the condition treated by the promoted drug or explicitly stated that the condition could be a “silent disease”. Among those advertisements that omitted symptom information, 54% were targeted to individuals who had already been diagnosed with the condition and were presumably aware of its symptoms. The remaining advertisements tended to be for conditions with well-known symptoms (eg, pregnancy, impotence, and tobacco addiction). Information about a precursor to the condition such as a cause or risk factor was provided in 27% of the advertisements. A total of 6% of advertisements provided precursor information by means of a set of diagnostic questions, such as a quiz that readers could use to assess their risk of being or becoming affected by the condition (data not diagramed). Information about condition prevalence (12% of advertisements) and clarifications about a condition-related misconception (9%) was rarely provided.

Information About Treatments

The Figure also displays the percentage of advertisements reporting each of the 6 types of treatment information. Most often present was information about a drug’s mechanism of action, found in 36% of the advertisements. An acknowledgement of the existence of one or more competing treatments was offered in 29% of the advertisements. Supportive behaviors such as changes in diet, physical activity, and sleeping patterns were reported in 24% of the advertisements. In our judgment, relevant supportive behaviors are often recommended by physicians for most of the conditions addressed in these advertisements. Readers were given information about time to onset of action in 20% of the advertisements and typical required treatment duration in 11%. A success rate estimate was rarely reported (9%).

Three of these treatment information codes were significantly associated with the medical conditions variable (all P values=.02). Supportive behaviors that could be used alone or to enhance the effectiveness of therapy were more likely to be found in diabetes and tobacco cessation treatments (75% and 67% of brands, respectively). Time to onset of action information was especially likely to be offered in advertisements for dermatological and urological problems (58% and 50%, respectively). Information about treatment duration was most often found in advertisements for infection and dermatological treatments (50% and 33%, respectively).

Indexes

For summative purposes we examined the condition information, treatment information, and overall education indexes for each of the 14 medical condition categories, using the drug brand as the unit of analysis. The average brand provided only 2.1 of the 5 types of information about the condition for which the drug was marketed. Only 1.2 of the 6 types of treatment information we coded was provided in the average brand-weighted advertisement. Summing across the condition and treatment information variables, the average number of educational codes present for these 101 brands was only 3.2 out of a possible score of 11 (range=1.0-7.3).

Next we categorized the brands under the medical condition category for which each was promoted Table 3. Despite weak statistical power, a significant difference across the 14 medical conditions was found for 2 of the 3 indexes, the condition information index (F [13,87]=3.05, P=.001) and the combined education index (F [13,87]=2.39, P=.008). On the basis of post hoc comparisons, both effects could be attributed to the greater provision of information in promotions for urologic brands than in HIV/AIDS brand advertisements.

Information Formats

Information about conditions and treatments was typically provided in narrative form. Tabular data or charts (eg, bar, pie, or column charts) were rarely used to provide information about the drug (2% of advertisements) or the medical condition (<1%). Diagrams and pictures were also rarely used to provide information about the effectiveness of the treatment (2% of advertisements) or the nature of the condition (7%).

Other Sources of Information

One view of DTC advertising is that it simply provides an introduction to a treatment and that more detailed patient education is best provided in other ways, such as with brochures and videotaped presentations or through the Internet. An explicit offer of printed or audiovisual information was provided in 35% of the advertisements, and a toll-free information telephone number was found in 73%. Increasingly, the Internet is being used as a means through which interested readers can obtain more information about advertised products. In 1996, 1997, and 1998, the percentages of advertisements that provided a Web site address were 14%, 33%, and 57%, respectively. Most telephone numbers were numeric (55%), but some of these and all Web addresses referenced a benefit of use (eg, 1-800-5-SHUT-EYE for a treatment of insomnia), the treated body part (eg, www.kidsears.com for a treatment of ear infections), the medical condition treated (eg, 1-800-66-ANGINA), the brand name of the drug (eg, www.atrovent.com), or the drug company’s name (eg, 1-800-GLAXO-RX).

Discussion

A time may come when DTC advertising is recommended for its educational value, but that day is not yet at hand. The advertisements that have appeared during the past decade have been superficial in their coverage of medical conditions and their treatments. Although most provide the name of the treated medical condition and its associated symptoms, the large majority do not inform potential patients about such basic matters as the risk factors for the condition or its prevalence. Likewise, these advertisements seldom educate patients about the mechanism of action by which the drug treats a particular condition, its success in doing so, alternative treatments, and behavioral changes that could augment or supplant treatment. To their credit, most of these promotions do offer the reader alternative ways of learning more about their condition and the advertised drug.

The medical community should exert pressure on the drug industry to incorporate more information about conditions and treatments in its advertising. It is in the industry’s best interest to do so. Advertising that incorporates quality health and drug information will have greater credibility, and deservedly so. Also, consumers are less likely to be influenced by messages that appear to be more promotional than informational.³¹ Thus, providing complete and accurate information is the right thing to do and may even enhance the effectiveness of DTC advertising. If such information is not provided voluntarily by the industry in future advertising, the medical establishment should lobby for regulation.

These results also highlight an important opportunity for professional organizations to contribute to consumer education on prescription drugs. According to the National Institute for Health Care Management, the most successfully promoted drugs fall into 5 categories: antidepressants, cholesterol-lowering agents, gastric acid reducers, oral antihistamines, and antihypertensives.³² Organizations such as the American Academy of Family Physicians and the American College of Physicians already produce patient informational materials, but these efforts could be intensified so physicians would have a ready source of “counter-detailing.” Patients requesting drugs for which the indications are questionable could be given a handout and told, “This is what my professional society has to say about _________. This information is produced by the best experts in the field and provides a more balanced view than what you will find in profit-motivated advertisements. Look it over, and let’s talk about this at our next visit.”

If the industry were to be prodded into taking a more educational stance in its consumer-targeted prescription drug advertising, the impact of this shift on physician-patient interactions would need to be investigated. A more educated patient may take less time to treat and counsel, might show greater adherence to treatment regimens, and could assume greater responsibility for his or her health. On the other hand, educational promotions may lead to requests from more determined patients for drugs that are not medically indicated, requiring time-consuming re-education by their physicians.

Limitations

Our study has limitations. We have evaluated the educational qualities of these advertisements by imposing a common set of standards for each promotion. A stronger approach would have been to convene a panel of experts for each of the many conditions treated by the promoted drugs to identify the specific details that consumers need to know about the condition and its treatment. Resource constraints prevented us from developing expert-based educational standards for each condition or disease. However, it is reasonable to expect the drug industry to provide to consumers basic information about the treatments being promoted and the conditions these drugs address. We acknowledge that particular content analytic codes may have been irrelevant to certain conditions. For instance, precursor information does not need to be provided when the causes of the condition are obvious (eg, advertisements for contraceptive drugs); mention of supportive lifestyle changes should not be demanded when helpful behavioral changes do not exist (eg, advertisements for hair loss treatments); and references to the presence of competing treatments should not be expected in the rare event that such treatments are nonexistent. Such exceptions aside, we believe that the 11 codes assessed are both fundamental and relevant to the vast majority of the conditions covered by these advertisements.

Also, with this preliminary investigation we sought only to assess the extent to which the industry is making an effort to provide information about medical conditions and treatments for those conditions. We did not examine the educational quality of these efforts, including the completeness and accuracy of information provided about conditions and treatments. Such assessments will require input from medical and pharmaceutical experts selected for their specialized knowledge.

Conclusions

We acknowledge that instances of informative advertising can readily be found in our sample of advertisements. Thus, although DTC advertising in general is not serving the information needs of consumers, there are companies and individuals within the industry who are motivated to treat their advertising as vehicles for effective health promotion through quality education. Billions of dollars will be spent in the next few years on consumer-targeted prescription drug promotions.⁴ Consumers will be very receptive to those advertisements that address their personal health needs and concerns³³; many will talk to their primary care physicians as a result of these promotions.³⁴ The drug industry thus has a tremendous opportunity to silence its critics and improve the public’s health by providing objective medical and drug information.³⁵

Acknowledgments

We wish to acknowledge the contributions made by Ronald Emerick, Robert LaGreca, Love Lord, and Sarah Shaw in the collection and coding of advertisements and by 2 anonymous peer reviewers for their thoughtful evaluations.

Related Resources:

• U.S. Food & Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising and Communications www.fda.gov/cder/ddmac/
• Public Citizen Health Research Group “Drugs” page, listing numerous government documents that describe recommendations for drug use, sales and marketing. http://www.citizen.org/hrg/publications/drugs.htm
• AARP Executive Summary: Are Consumers Well Informed About Prescription Drugs? The Impact of Printed Direct-to-Consumer Advertising http://research.aarp.org/health/2000_04_advertising_1.html
• drkoop.com-Perspective: ‘Direct-to-Consumer’ Advertising of Prescription Drugs is More Harmful than Helpful to Consumers www.drkoop.com/news/focus/november/dtc_no.html

The appropriateness of direct-to-consumer (DTC) prescription drug advertising has been a topic of heated discussion in recent years.^1,2 This debate is likely to intensify as the drug industry’s advertising expenditures continue to increase^3,4 and the marketing channels employed expand to include television, which may not lend itself to highly informative messages, and the Internet, which is difficult to regulate.⁵ Ironically, DTC advertising proponents and opponents have most often based their positions on assumptions about the informational value of such promotions.⁶ However, empirical data on this issue are sparse.

The opponents of DTC advertising argue that the objectives of drug promotion and health education are inherently at odds.⁷ It has been noted that the aim of DTC advertising is to increase sales, not optimize health care.^8,9 It has been presumed that the profit motive discourages the provision of complete and accurate information about pharmaceuticals.¹⁰ Reports have documented violations of the public trust¹¹ and the dissemination of misleading information to health care professionals.^12,13 If even highly trained physicians are prone to influence by commercial rather than scientific sources of pharmaceutical information,¹⁴ how can consumers protect themselves from misleading claims? To make matters worse, the public may be ill equipped to fully understand such advertising, no matter how accurate its content might be.^7,15

Defenders of DTC advertising counter these arguments by suggesting that selling and educating are not necessarily incompatible goals¹⁶ and that it is in the industry’s self-interest to be truthful with consumers.¹⁷ Although instances of misleading DTC advertising can be identified, such cases are said to be rare.⁵ Proponents of DTC advertising typically attribute greater sophistication to the public than critics do,¹⁶ rejecting the notion that consumers cannot comprehend such advertising.¹⁸ In any regard, misunderstandings can be corrected by the physician, in whom the power to prescribe ultimately resides.¹ Although many physicians oppose DTC advertising, a majority feel that such advertisements might help patients become better informed about drugs,¹⁹ conjecture that has empirical support.²⁰

We have attempted to contribute to the debate on the value of DTC advertising by describing its content. In a recent JFP article,²¹ we documented the types of appeals and inducements used in these promotions. In this article we describe the scope of the educational efforts represented in advertisements appearing in consumer publications from 1989 through 1998. After identifying basic issues that most DTC advertisements should address to have educational merit, we examined the extent to which such promotions provide consumers with information about medical conditions, including their symptoms, precursors, and prevalence. It has been argued that DTC advertising increases the public’s awareness of these aspects of diseases and other health conditions. This kind of patient education is said to help people to take responsibility for their health by teaching them how to recognize disease and motivating them to seek medical attention for conditions that might otherwise be left undiagnosed and untreated.^1,22-24

We then examined the extent to which DTC advertising incorporates information about treatments for those conditions. It has been said that consumer-targeted prescription drug advertising provides the public with valuable information about available treatments that leads to a better match between patients’ needs and available drugs.²⁵ Specifically, we examined the extent to which DTC advertising offers details about promoted drugs’ mechanisms of action, the duration and success of advertised treatments, behavioral modifications that can improve the patient’s health independently or in concert with drug treatment, and competing treatments.

Methods

Sampling Procedure

Major popular magazines were ranked in terms of the average number of advertising pages sold from 1989 through 1996 (the last year for which data were available) and then grouped into an established set of categories.²⁶ The highest-ranked publication within each of 13 categories was selected for inclusion in our sample. To these magazines we added 5 publications with audiences composed of narrower segments of our population defined by ethnicity, age, and sexual orientation. Thus, we garnered our sample of advertisements from 18 diverse publications Table 1. All the advertisements promoting a specific, named prescription drug that appeared in these magazines from January 1989 through December 1998 were photocopied. Advertisements for the same brand often differed in nonsubstantive ways and were thus coded as a single case based on detailed rules that are available from the authors. After aggregating essentially identical advertisements, 320 remained for analysis covering 101 distinct brands.

Medical Conditions Classification

Each advertisement was grouped in one of 14 medical condition categories based on the indication of the marketed drug. The numbers of advertisements and brands within each of these categories were as follows: allergies (46 advertisements, 8 brands); cancer (2, 2); cardiovascular disease (36, 10); dermatologic conditions (37, 12); diabetes (9, 4); gastrointestinal/nutritional disorders (17, 7); human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS; 33, 11); infections, non-HIV (16, 6); musculoskeletal disorders (17, 7); obstetric/gynecologic conditions (45, 10); psychiatric/neurologic disorders (17, 7); respiratory disorders (3, 3); tobacco addiction (23, 6); and urologic conditions (19, 8).

Advertisement Coding

Two coders independently analyzed each advertisement. Our goal for this classification effort was to determine whether each advertisement contained 5 kinds of information pertaining to the focal medical condition and 6 types of drug treatment information Table 2.

Statistical Analyses

We examined each of the 11 education codes listed in Table 2 and computed 3 more general measures. We created a condition information index by summing the number of medical condition codes present within each advertisement (theoretical range=0-5). Likewise, a treatment information index was computed by summing the number of treatment codes present within each advertisement (theoretical range=0-6). A combined education index was created by adding the condition and treatment information variables (theoretical range=0-11).

The reliability of coding was assessed with the k statistic, a measure of inter-rater agreement with a range of 0 to 1.0.²⁷ The mean k value for the variables reported was 0.91 (range=0.88-1.0). Landis and Koch²⁸ suggest that k values in this range can be considered “almost perfect.”

We employed 2 units of analyses. For our descriptive analyses, the advertisement served as the unit of analysis (N=320). We relied on the brand (N=101) as the unit of analysis when computing cross-tabulations and one-way analyses of variance. Using the advertisement as the unit for inferential statistical analyses would have violated the assumption of independence of observations,²⁹ because most advertisements for a particular brand represent alterations of earlier promotions for that brand. The advertisements for each brand were aggregated into a single case by weighting; each advertisement was assigned a weight of 1/n, with n representing the number of advertisements for that brand. When a significant chi-square value was obtained for a cross-tabulation, the source of significance within the table was determined by examining the cell-adjusted standardized residuals using a P <.05 criterion.³⁰

Results

The Figure shows the percentage of advertisements for which the 5 medical condition information codes and 6 treatment information codes were present. These results have been ordered in the Figure on the basis of frequency of occurrence.

Information About Medical Conditions

The medical condition name was provided in virtually all of the advertisements (95%). This information was excluded in 1 “teaser ad” that simply showed a bottle of tablets for a forthcoming treatment, in 7 advertisements alerting patients of a new formulation of a drug already prescribed for them, and in 9 advertisements notifying patients of an alternative delivery system for an established treatment. Sixty percent of the advertisements described at least one symptom of the condition treated by the promoted drug or explicitly stated that the condition could be a “silent disease”. Among those advertisements that omitted symptom information, 54% were targeted to individuals who had already been diagnosed with the condition and were presumably aware of its symptoms. The remaining advertisements tended to be for conditions with well-known symptoms (eg, pregnancy, impotence, and tobacco addiction). Information about a precursor to the condition such as a cause or risk factor was provided in 27% of the advertisements. A total of 6% of advertisements provided precursor information by means of a set of diagnostic questions, such as a quiz that readers could use to assess their risk of being or becoming affected by the condition (data not diagramed). Information about condition prevalence (12% of advertisements) and clarifications about a condition-related misconception (9%) was rarely provided.

Information About Treatments

The Figure also displays the percentage of advertisements reporting each of the 6 types of treatment information. Most often present was information about a drug’s mechanism of action, found in 36% of the advertisements. An acknowledgement of the existence of one or more competing treatments was offered in 29% of the advertisements. Supportive behaviors such as changes in diet, physical activity, and sleeping patterns were reported in 24% of the advertisements. In our judgment, relevant supportive behaviors are often recommended by physicians for most of the conditions addressed in these advertisements. Readers were given information about time to onset of action in 20% of the advertisements and typical required treatment duration in 11%. A success rate estimate was rarely reported (9%).

Three of these treatment information codes were significantly associated with the medical conditions variable (all P values=.02). Supportive behaviors that could be used alone or to enhance the effectiveness of therapy were more likely to be found in diabetes and tobacco cessation treatments (75% and 67% of brands, respectively). Time to onset of action information was especially likely to be offered in advertisements for dermatological and urological problems (58% and 50%, respectively). Information about treatment duration was most often found in advertisements for infection and dermatological treatments (50% and 33%, respectively).

Indexes

For summative purposes we examined the condition information, treatment information, and overall education indexes for each of the 14 medical condition categories, using the drug brand as the unit of analysis. The average brand provided only 2.1 of the 5 types of information about the condition for which the drug was marketed. Only 1.2 of the 6 types of treatment information we coded was provided in the average brand-weighted advertisement. Summing across the condition and treatment information variables, the average number of educational codes present for these 101 brands was only 3.2 out of a possible score of 11 (range=1.0-7.3).

Next we categorized the brands under the medical condition category for which each was promoted Table 3. Despite weak statistical power, a significant difference across the 14 medical conditions was found for 2 of the 3 indexes, the condition information index (F [13,87]=3.05, P=.001) and the combined education index (F [13,87]=2.39, P=.008). On the basis of post hoc comparisons, both effects could be attributed to the greater provision of information in promotions for urologic brands than in HIV/AIDS brand advertisements.

Information Formats

Information about conditions and treatments was typically provided in narrative form. Tabular data or charts (eg, bar, pie, or column charts) were rarely used to provide information about the drug (2% of advertisements) or the medical condition (<1%). Diagrams and pictures were also rarely used to provide information about the effectiveness of the treatment (2% of advertisements) or the nature of the condition (7%).

Other Sources of Information

One view of DTC advertising is that it simply provides an introduction to a treatment and that more detailed patient education is best provided in other ways, such as with brochures and videotaped presentations or through the Internet. An explicit offer of printed or audiovisual information was provided in 35% of the advertisements, and a toll-free information telephone number was found in 73%. Increasingly, the Internet is being used as a means through which interested readers can obtain more information about advertised products. In 1996, 1997, and 1998, the percentages of advertisements that provided a Web site address were 14%, 33%, and 57%, respectively. Most telephone numbers were numeric (55%), but some of these and all Web addresses referenced a benefit of use (eg, 1-800-5-SHUT-EYE for a treatment of insomnia), the treated body part (eg, www.kidsears.com for a treatment of ear infections), the medical condition treated (eg, 1-800-66-ANGINA), the brand name of the drug (eg, www.atrovent.com), or the drug company’s name (eg, 1-800-GLAXO-RX).

Discussion

A time may come when DTC advertising is recommended for its educational value, but that day is not yet at hand. The advertisements that have appeared during the past decade have been superficial in their coverage of medical conditions and their treatments. Although most provide the name of the treated medical condition and its associated symptoms, the large majority do not inform potential patients about such basic matters as the risk factors for the condition or its prevalence. Likewise, these advertisements seldom educate patients about the mechanism of action by which the drug treats a particular condition, its success in doing so, alternative treatments, and behavioral changes that could augment or supplant treatment. To their credit, most of these promotions do offer the reader alternative ways of learning more about their condition and the advertised drug.

The medical community should exert pressure on the drug industry to incorporate more information about conditions and treatments in its advertising. It is in the industry’s best interest to do so. Advertising that incorporates quality health and drug information will have greater credibility, and deservedly so. Also, consumers are less likely to be influenced by messages that appear to be more promotional than informational.³¹ Thus, providing complete and accurate information is the right thing to do and may even enhance the effectiveness of DTC advertising. If such information is not provided voluntarily by the industry in future advertising, the medical establishment should lobby for regulation.

These results also highlight an important opportunity for professional organizations to contribute to consumer education on prescription drugs. According to the National Institute for Health Care Management, the most successfully promoted drugs fall into 5 categories: antidepressants, cholesterol-lowering agents, gastric acid reducers, oral antihistamines, and antihypertensives.³² Organizations such as the American Academy of Family Physicians and the American College of Physicians already produce patient informational materials, but these efforts could be intensified so physicians would have a ready source of “counter-detailing.” Patients requesting drugs for which the indications are questionable could be given a handout and told, “This is what my professional society has to say about _________. This information is produced by the best experts in the field and provides a more balanced view than what you will find in profit-motivated advertisements. Look it over, and let’s talk about this at our next visit.”

If the industry were to be prodded into taking a more educational stance in its consumer-targeted prescription drug advertising, the impact of this shift on physician-patient interactions would need to be investigated. A more educated patient may take less time to treat and counsel, might show greater adherence to treatment regimens, and could assume greater responsibility for his or her health. On the other hand, educational promotions may lead to requests from more determined patients for drugs that are not medically indicated, requiring time-consuming re-education by their physicians.

Limitations

Our study has limitations. We have evaluated the educational qualities of these advertisements by imposing a common set of standards for each promotion. A stronger approach would have been to convene a panel of experts for each of the many conditions treated by the promoted drugs to identify the specific details that consumers need to know about the condition and its treatment. Resource constraints prevented us from developing expert-based educational standards for each condition or disease. However, it is reasonable to expect the drug industry to provide to consumers basic information about the treatments being promoted and the conditions these drugs address. We acknowledge that particular content analytic codes may have been irrelevant to certain conditions. For instance, precursor information does not need to be provided when the causes of the condition are obvious (eg, advertisements for contraceptive drugs); mention of supportive lifestyle changes should not be demanded when helpful behavioral changes do not exist (eg, advertisements for hair loss treatments); and references to the presence of competing treatments should not be expected in the rare event that such treatments are nonexistent. Such exceptions aside, we believe that the 11 codes assessed are both fundamental and relevant to the vast majority of the conditions covered by these advertisements.

Also, with this preliminary investigation we sought only to assess the extent to which the industry is making an effort to provide information about medical conditions and treatments for those conditions. We did not examine the educational quality of these efforts, including the completeness and accuracy of information provided about conditions and treatments. Such assessments will require input from medical and pharmaceutical experts selected for their specialized knowledge.

Conclusions

We acknowledge that instances of informative advertising can readily be found in our sample of advertisements. Thus, although DTC advertising in general is not serving the information needs of consumers, there are companies and individuals within the industry who are motivated to treat their advertising as vehicles for effective health promotion through quality education. Billions of dollars will be spent in the next few years on consumer-targeted prescription drug promotions.⁴ Consumers will be very receptive to those advertisements that address their personal health needs and concerns³³; many will talk to their primary care physicians as a result of these promotions.³⁴ The drug industry thus has a tremendous opportunity to silence its critics and improve the public’s health by providing objective medical and drug information.³⁵

Acknowledgments

We wish to acknowledge the contributions made by Ronald Emerick, Robert LaGreca, Love Lord, and Sarah Shaw in the collection and coding of advertisements and by 2 anonymous peer reviewers for their thoughtful evaluations.

Related Resources:

• U.S. Food & Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising and Communications www.fda.gov/cder/ddmac/
• Public Citizen Health Research Group “Drugs” page, listing numerous government documents that describe recommendations for drug use, sales and marketing. http://www.citizen.org/hrg/publications/drugs.htm
• AARP Executive Summary: Are Consumers Well Informed About Prescription Drugs? The Impact of Printed Direct-to-Consumer Advertising http://research.aarp.org/health/2000_04_advertising_1.html
• drkoop.com-Perspective: ‘Direct-to-Consumer’ Advertising of Prescription Drugs is More Harmful than Helpful to Consumers www.drkoop.com/news/focus/november/dtc_no.html

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals in the United States is a fast-growing, much-heralded, and important phenomenon. The purpose of this type of advertising is to induce consumers to request prescriptions from their physicians, usually from their primary care physician.¹ The amount of money the pharmaceutical industry spends annually on DTC advertising is expected to quadruple current levels during the next few years and may approach $7.5 billion by 2005.^2,3 Regulatory oversight of this form of advertising has been the responsibility of the US Food and Drug Administration (FDA) since 1962.⁴ Historically, the industry’s advertising has been placed in medical journals. However, in the early 1980s several companies began to promote their drugs directly to consumers. The FDA obtained a voluntary moratorium on this type of advertising in 1983, which was then lifted in 1985.⁵

Despite the FDA’s green light, the industry did not resume advertising to consumers in earnest until 1990. Regulations have dictated that a DTC advertisement must include a brief summary of indications, side effects, and contraindications.⁶ As a result, advertisements were initially placed primarily in magazines and newspapers, because it was difficult to fulfill the brief summary requirement in a broadcast advertisement.⁷ This requirement was relaxed in 1997, leading to the recent emergence of DTC advertisements on television.⁸

Members of the medical profession have editorialized on the promise^9,10 and pitfalls¹¹ of DTC advertising. Disputes have focused on issues such as whether this type of advertising simultaneously informs and influences consumers,¹² enhances or worsens health outcomes,^13,14 leads to the treatment of underserved patients or to an overmedicated society,¹⁵ improves or hurts the physician-patient relationship,¹⁶ and educates or confuses the consumer.¹⁷ We seek to improve the quality of this policy debate through a descriptive analysis of the content of prescription drug promotions that have appeared in popular US magazines from 1989 to 1998.

Our study addresses 4 sets of concerns. First, we examine trends in the breadth of DTC advertising to augment available data on advertising expenditures. We also profile the medical conditions for which advertising has been used, because viewpoints about the appropriateness of DTC promotion sometimes have as their premise assumptions about the seriousness of the conditions for which drugs are advertised.¹⁸ Second, we examine the intended target of these advertisements to better understand the promotional strategies of the drug industry. Third, we describe the inducements offered to readers to promote demand for drugs. Fourth, we document the advertising appeals used to enhance a patient’s interest in the drugs, including selling points pertaining to the promoted drug’s effectiveness, social-psychological benefits, safety, and ease of use. In all likelihood, these appeals provide patients with motivation to request prescriptions and with arguments to present to the family physician.

Methods

Sampling Procedure

Advertisements were collected from 18 diverse magazines. Based on the annual reports of the market research firm CMR, leading American consumer magazines were ranked in terms of the average number of advertising pages sold from 1989 through 1996 (the last year for which data were available at the commencement of our project). The magazines were then stratified according to the classifications reported in Magazines for Libraries.¹⁹ The highest-ranked publication within each of the following 13 categories was selected for inclusion in our sample: business (Business Week), fishing/hunting/guns (Field & Stream), food/wine (Gourmet), home (Better Homes and Gardens), men (GQ), music (Rolling Stone), news and opinion (Time), parenting (Parents), personal finance (Money Magazine), sports (Sports Illustrated), tabloid/general editorial (Reader’s Digest), women (Vogue), and medicine/health (Prevention). To these magazines we added 5 publications targeted to narrower segments of the population defined by ethnicity (Ebony and Hispanic), age (Modern Maturity and New Choices for Best Years), and sexual orientation (The Advocate). With the exception of promotions for HIV treatments, which usually appeared in The Advocate, most of the advertisements in these supplemental publications were also found in the primary sample of magazines.

All product-specific prescription drug advertisements appearing in these magazines from January 1989 through December 1998 were photocopied. We excluded disease education messages that did not mention a specific drug and advertisements for medical devices and veterinary drugs. Advertisements for the same brand often differed in nonsubstantive ways and were coded as a single case.*

Two judges independently coded each advertisement. To maximize reliability, almost all codes involved a determination of the presence or absence of a word or phrase in the advertisement. The mean kappa across all classifications reported here was .93 (range=0.90-1.0).

Classifications

Medical conditions. We classified each drug brand into 1 of 14 medical condition categories Table 1. In most cases, this was a straightforward process; however, when a drug was promoted for more than one indication it was classified according to the indication for which it was most extensively advertised.

Inducements. The advertisements were coded for the presence or absence of an offer of each of the following inducements: patient support services (eg, assistance in helping the reader find a local support group for smoking cessation), additional information about the drug or condition in print or audiotape/video form, and monetary incentives (rebate, discount coupon, money-back guarantee, or free product trial).

Advertising appeals. Each advertisement wascoded for the presence or absence of a number of inductively derived claims about the drug’s effectiveness, social-psychological benefits, ease of use, and safety. We looked at whether each of 42 adjectives, adjectival phrases, or adverbs was used to describe the drug’s nature or impact. We initially coded for the presence or absence of each of these terms or phrases and then collapsed across related claims to create more general product attribute variables as shown in Table 2. For instance, to create the attribute category “Innovative,” we coded for the terms “advancement,” “breakthrough,” “a first,” the “only” drug of kind, “innovative,” “novel,” and “new” and then recoded each advertisement for whether at least one of these descriptors was used to depict the drug.

Statistical Analyses

We employed 2 units of analysis. In most instances, the unit of analysis was the advertisement, with descriptive statistics serving as the primary analytic tool. Use of the advertisement as the unit of analysis, however, is inappropriate when inferential tests such as the chi square are used. Doing so would violate the assumption of independence of observations, because most advertisements for a brand represent modifications of previously placed advertisements. We thus relied on the brand as the unit of analysis when using inferential statistical procedures. Specifically, each brand was treated as a single case by giving each advertisement for the brand a weight of 1/n, when n represents the number of advertisements for that brand. For instance, if 5 advertisements were found for a particular brand, each advertisement was given a weight of 0.2 in these analyses. This approach allows for fractional values on the coded variables. For example, if half the advertisements for a brand provided a monetary incentive, the value for the brand on that variable would be 0.5. Thus, each brand contributed equally to the analyses regardless of the extent to which it was advertised. This is appropriate, because the objective of content analysis is to describe message content, not the effects of that content. In 2 analyses, trends in the frequency with which advertisements and brands were introduced during the decade were examined using the Statistical Package for Social Sciences curve fit procedure.²⁰

Results

After aggregating essentially identical advertisements, 320 remained for analysis, covering 101 brands Table 1. Sixty-eight percent of the brands were oral medications; 17% were topicals or transdermals; 7% required injections; 5% were inhalants; 2% were implants; and one brand (less than 1%) was a suppository.

Trends in DTC Advertising

The first set of research questions pertained to trends in DTC advertising. As shown in Table 1, the most common brands advertised were for dermatologic conditions, HIV/AIDS, cardiovascular disease, and obstetrical/gynecological conditions. Treatments for allergies, gastrointestinal conditions, musculoskeletal ailments, psychiatric/neurologic disorders, and urological conditions were also well represented. Brands for cancer, diabetes, infectious/non-HIV diseases, respiratory conditions, and tobacco addiction were less common.

We examined trends in the breadth of DTC advertising in 2 ways. First, to examine changes in the introduction of new brands, each of the 101 brands was classified under the calendar year in which it first appeared in the sampled publications. These data are reported in the first data series in the Figure 1, which shows a tendency for new brand introductions to increase during the 10-year period. Although brand introductions leveled off in 1996, the overall trend is best modeled as a linear relationship (adjusted R2=.80; B=2.03; P=.0003). Second, we classified each of the 320 advertisements under the calendar year in which it first appeared. These data are displayed in the second data series in the Figure 1. The number of new advertisement introductions grew from only 3 in 1989 to 76 in 1998. The best-fitting trend line for this increase is provided by a linear model (adjusted R2=.91; B=7.45; P <.0001).

Target Audiences

Our second set of questions concerned the kinds of consumers to which these advertisements are directed. Approximately 98% of the advertisements were judged as directed at the potential user of the drug; the remaining advertisements were aimed at third-party intermediaries (ie, the parent, spouse, or adult child of the potential patient). With regard to the sex of the targeted reader, 23% of the advertisements (18% of the brands) were judged as directed exclusively at women; 9% of advertisements (10% of the brands) were targeted exclusively to men; and 68% of advertisements (72% of the brands) were directed at both sexes.

Inducements

Our third set of questions addressed the nature of the inducements extended to consumers to encourage demand for the advertised pharmaceuticals. We examined 3 types of: patient support, information, and financial inducements. Patient support services were extended in only 3% of advertisements and 4% of brands.

Readers were offered additional printed information, such as free brochures or booklets in 34% of the advertisements (39% of brands). Audiotaped or videotaped information was available in 3% of the advertisements (6% of brands). Aggregating across format, 35% of advertisements (39% of brands) offered information in print or audio/video form. Offers of additional information were typically made available to the reader through a toll-free number.

With regard to monetary incentives, 13% of advertisements (9% of brands) offered a rebate or discount coupon. Only 1% of the advertisements provided a money-back guarantee; such a guarantee was extended at least once in the advertising campaigns for 3% of the brands. A total of 3% of the advertisements (4% of brands) offered a free sample of the product for the patient’s trial use. Of course, these inducements were available to patients through prescription only. Aggregating across these 3 monetary incentives, we found that 17% of the advertisements (17% of brands) offered at least one incentive.

Table 3 shows the percentage of advertisements that included patient support offers, information offers (in any format), and financial incentives (of any type) for each of the 14 medical condition categories. Virtually all patient support offers were extended in advertisements for tobacco cessation products. Information offers were most likely to be found in advertisements for cancer and tobacco addiction but were also common in advertisements for treatments of allergies and conditions of a cardiovascular, dermatologic, obstetric/gynecologic, and urological nature. Monetary inducements were found primarily in advertisements for treatments of allergies, dermatologic problems, and respiratory conditions.

Advertising Appeals

Finally, we examined the nature of appeals used in DTC advertisements. We initially examined the frequency with which each appeal was used across the 320 advertisements. Beginning with the most common appeal, the frequencies were: “effective” (57% of advertisements), “controls symptoms” and “innovative” (41% each), “prevents” condition (16%), “powerful” (9%), “reduced mortality” (7%), “dependable” (4%), and “cures” (3%). The percentage of advertisements using each of the social-psychological benefits claims was: “psychological enhancement” (11%), “lifestyle enhancement” (6%), and “social enhancement” (3%). The ease of use appeals were: “convenience” (38%), “quick acting” (6%), “economical” (5%), and “easy on system” (3%). The safety-related appeals were: “nonmedicated” (14%), “safe” (11%), “natural” (7%), and “not addictive” (5%).

We expected that the use of particular appeals would vary across the medical conditions treated by the promoted drugs. Using brand as the unit of analysis, 19 separate cross-tabulations were conducted, one for each appeal listed in Table 2 (therapeutic effectiveness, social-psychological benefits, ease of use, and safety-related), to examine the significance of association between medical condition category and the use of the appeal. Significant associations (P <.05) between the medical condition classification and appeal use were found for 7 of the appeals, for which adjusted standardized residuals were used to identify sources of significance. We organized these results around the medical condition categories for which an appeal was found to be significantly overrepresented or underrepresented.

Brands for allergy treatments were more likely to claim symptom control (100% of brands vs 41% of the total sample) and treatment without feelings of being medicated (88% vs 9%). Cancer and cardiovascular drugs were more likely to claim prolonged life as a benefit (100% and 20% of brands, respectively) than the total sample (6% of brands). In addition, cardiovascular treatments were more likely to offer economic benefits (40% of brands vs 6% for the entire sample), an effect largely attributable to comparative advertisements focusing on price. Three fourths of brands claiming to offer a powerful treatment fell into the HIV/AIDS category; 55% of those brands made such a claim compared with only 8% for all brands. HIV/AIDS brands were significantly less likely to claim symptom control as a benefit (9% of brands compared with 41% of all brands). Prevention was much more likely to be advanced in promotions for obstetric/gynecologic brands (60%, primarily contraceptives) and respiratory brands (67%) than the sample as a whole (17% of all brands). Respiratory brands were also more likely to claim symptom control as a benefit (100% vs 41% of the sample). Finally, respiratory treatments were more likely to make lifestyle-enhancement claims (67% vs 10% of all brands).

Discussion

The results of our study inform policy discussions on the appropriateness of DTC prescription drug advertising. Although content analyses of drug advertisements appearing in medical journals have been reported, our investigation is the first systematic content analysis of DTC drug advertisements. Similar to previous reports on advertising expenditures, our study reveals that DTC pharmaceutical marketing has increased substantially over the years. Furthermore, DTC advertising has been used to promote drugs for serious conditions; 30% of brands represented in the sample were for such life-threatening conditions as asthma, cancer, cardiovascular disease, diabetes, and HIV infection.

This dramatic increase underscores the need for research on the effects of DTC advertising on drug costs. It is still unclear whether such expenditures are passed on to the consumer through higher prices or promote competition that lowers prices.^21,22 We suspect that advertising-induced increases in demand for a drug may raise costs substantially when alternative treatments are not available or are substantially less effective. Conversely, promotion may spur competition on the basis of price within therapeutic categories when several treatment options are available. Of course, even expensive drugs can lower total health care expenditures if they provide effective treatment for costly conditions.

Although the breadth of prescription treatments advertised to consumers is impressive, the vast majority of drugs have not been promoted in this manner. Clearly, treatments for certain kinds of conditions are more likely to be advertised to consumers. Most of the drugs advertised are for common chronic conditions (approximately three fourths of the brands in Table 1. Drugs for conditions that may not be recognized as pathologic or treatable by consumers (eg, toenail fungus), under treated ailments (eg, hypertension, depression), and conditions not previously treatable with medication (eg, erectile dysfunction) are also well represented. Advertisements for treatments of acute conditions were rare (eg, antibiotics).

We also investigated the kind of inducements used to promote prescription drugs to consumers. The most common inducement was the offer of additional information. More than one third of the advertisers extended an invitation to the reader to request further information about the drug or condition in print or audio/video form. DTC advertising has often been justified on the grounds that it offers a valuable opportunity to educate the public about diseases and treatments. Future research should determine if these brochures and tapes provide quality education or simply try to sell the product.

Slightly less than 1 in 5 advertisements offered a monetary incentive to the reader for using the promoted drug. We believe that such incentives may be inappropriate when issued to people who have not had a diagnosis of the indicated condition.²³ These inducements also create the potential for antagonism between the patient who feels denied a bargain and the physician who believes that the drug is not indicated.

Our final objective was to describe the types of appeals used to sell prescription drugs to consumers. This analysis highlights areas in which the industry’s advertising requires careful monitoring. We are troubled, for instance, by the finding that two fifths of these advertisements made claims of “innovativeness.” Since advertisers often use “new and improved” claims to sell consumer products, it is not surprising that this heuristic phrasing is used to market pharmaceuticals. In truth, when it comes to drugs, what is new is not necessarily better. Most new drugs offer few advantages over older drugs and have less understood safety profiles.

Also of concern is the infrequency with which appeals to cost savings are used. Such appeals were found in only 1 out of every 20 advertisements. The provision of price information, including comparisons of costs with competing drugs, has been mentioned as one mechanism by which price competition could be fostered. We question whether such comparisons would improve the economic and physical health of patients but believe it is disingenuous for proponents of DTC advertising to advance this argument when cost information is seldom provided.

Limitations

Our study has limitations. Most notably, content analysis by its very nature seeks to explicate message form and content, not message effects. Policy discussions must be based on careful analyses of what the drug industry is telling consumers, but such analyses need to be augmented with data that show the effects of DTC advertising on patients’ drug information-seeking, physicians’ prescribing decisions, and ultimately on health outcomes. We also focused exclusively on the text of these advertisements; visual arguments are often used in advertising, including DTC drug advertising.²⁴ Finally, our sample was restricted to advertisements appearing in US magazines.

Conclusions

The pharmaceutical industry has turned to consumer-targeted prescription drug advertising to increase Americans’ demand for many of its products. If the current trend continues, such advertising could become the major source of information through which consumers learn about prescription drugs. As such, it is imperative that family physicians take an occasional look at the magazines in their own offices to keep abreast of the specific drugs being promoted to their patients. If DTC advertising is to be regulated properly, there is much we will need to learn about how these advertisements are influencing consumers and what impact they have on the physician-patient relationship

Acknowledgments

The authors wish to acknowledge the contributions made by Ronald Emerick, Robert LaGreca, Love Lord, and Sarah Shaw in the collection and coding of advertisements.

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals in the United States is a fast-growing, much-heralded, and important phenomenon. The purpose of this type of advertising is to induce consumers to request prescriptions from their physicians, usually from their primary care physician.¹ The amount of money the pharmaceutical industry spends annually on DTC advertising is expected to quadruple current levels during the next few years and may approach $7.5 billion by 2005.^2,3 Regulatory oversight of this form of advertising has been the responsibility of the US Food and Drug Administration (FDA) since 1962.⁴ Historically, the industry’s advertising has been placed in medical journals. However, in the early 1980s several companies began to promote their drugs directly to consumers. The FDA obtained a voluntary moratorium on this type of advertising in 1983, which was then lifted in 1985.⁵

Despite the FDA’s green light, the industry did not resume advertising to consumers in earnest until 1990. Regulations have dictated that a DTC advertisement must include a brief summary of indications, side effects, and contraindications.⁶ As a result, advertisements were initially placed primarily in magazines and newspapers, because it was difficult to fulfill the brief summary requirement in a broadcast advertisement.⁷ This requirement was relaxed in 1997, leading to the recent emergence of DTC advertisements on television.⁸

Members of the medical profession have editorialized on the promise^9,10 and pitfalls¹¹ of DTC advertising. Disputes have focused on issues such as whether this type of advertising simultaneously informs and influences consumers,¹² enhances or worsens health outcomes,^13,14 leads to the treatment of underserved patients or to an overmedicated society,¹⁵ improves or hurts the physician-patient relationship,¹⁶ and educates or confuses the consumer.¹⁷ We seek to improve the quality of this policy debate through a descriptive analysis of the content of prescription drug promotions that have appeared in popular US magazines from 1989 to 1998.

Our study addresses 4 sets of concerns. First, we examine trends in the breadth of DTC advertising to augment available data on advertising expenditures. We also profile the medical conditions for which advertising has been used, because viewpoints about the appropriateness of DTC promotion sometimes have as their premise assumptions about the seriousness of the conditions for which drugs are advertised.¹⁸ Second, we examine the intended target of these advertisements to better understand the promotional strategies of the drug industry. Third, we describe the inducements offered to readers to promote demand for drugs. Fourth, we document the advertising appeals used to enhance a patient’s interest in the drugs, including selling points pertaining to the promoted drug’s effectiveness, social-psychological benefits, safety, and ease of use. In all likelihood, these appeals provide patients with motivation to request prescriptions and with arguments to present to the family physician.

Methods

Sampling Procedure

Advertisements were collected from 18 diverse magazines. Based on the annual reports of the market research firm CMR, leading American consumer magazines were ranked in terms of the average number of advertising pages sold from 1989 through 1996 (the last year for which data were available at the commencement of our project). The magazines were then stratified according to the classifications reported in Magazines for Libraries.¹⁹ The highest-ranked publication within each of the following 13 categories was selected for inclusion in our sample: business (Business Week), fishing/hunting/guns (Field & Stream), food/wine (Gourmet), home (Better Homes and Gardens), men (GQ), music (Rolling Stone), news and opinion (Time), parenting (Parents), personal finance (Money Magazine), sports (Sports Illustrated), tabloid/general editorial (Reader’s Digest), women (Vogue), and medicine/health (Prevention). To these magazines we added 5 publications targeted to narrower segments of the population defined by ethnicity (Ebony and Hispanic), age (Modern Maturity and New Choices for Best Years), and sexual orientation (The Advocate). With the exception of promotions for HIV treatments, which usually appeared in The Advocate, most of the advertisements in these supplemental publications were also found in the primary sample of magazines.

All product-specific prescription drug advertisements appearing in these magazines from January 1989 through December 1998 were photocopied. We excluded disease education messages that did not mention a specific drug and advertisements for medical devices and veterinary drugs. Advertisements for the same brand often differed in nonsubstantive ways and were coded as a single case.*

Two judges independently coded each advertisement. To maximize reliability, almost all codes involved a determination of the presence or absence of a word or phrase in the advertisement. The mean kappa across all classifications reported here was .93 (range=0.90-1.0).

Classifications

Medical conditions. We classified each drug brand into 1 of 14 medical condition categories Table 1. In most cases, this was a straightforward process; however, when a drug was promoted for more than one indication it was classified according to the indication for which it was most extensively advertised.

Inducements. The advertisements were coded for the presence or absence of an offer of each of the following inducements: patient support services (eg, assistance in helping the reader find a local support group for smoking cessation), additional information about the drug or condition in print or audiotape/video form, and monetary incentives (rebate, discount coupon, money-back guarantee, or free product trial).

Advertising appeals. Each advertisement wascoded for the presence or absence of a number of inductively derived claims about the drug’s effectiveness, social-psychological benefits, ease of use, and safety. We looked at whether each of 42 adjectives, adjectival phrases, or adverbs was used to describe the drug’s nature or impact. We initially coded for the presence or absence of each of these terms or phrases and then collapsed across related claims to create more general product attribute variables as shown in Table 2. For instance, to create the attribute category “Innovative,” we coded for the terms “advancement,” “breakthrough,” “a first,” the “only” drug of kind, “innovative,” “novel,” and “new” and then recoded each advertisement for whether at least one of these descriptors was used to depict the drug.

Statistical Analyses

We employed 2 units of analysis. In most instances, the unit of analysis was the advertisement, with descriptive statistics serving as the primary analytic tool. Use of the advertisement as the unit of analysis, however, is inappropriate when inferential tests such as the chi square are used. Doing so would violate the assumption of independence of observations, because most advertisements for a brand represent modifications of previously placed advertisements. We thus relied on the brand as the unit of analysis when using inferential statistical procedures. Specifically, each brand was treated as a single case by giving each advertisement for the brand a weight of 1/n, when n represents the number of advertisements for that brand. For instance, if 5 advertisements were found for a particular brand, each advertisement was given a weight of 0.2 in these analyses. This approach allows for fractional values on the coded variables. For example, if half the advertisements for a brand provided a monetary incentive, the value for the brand on that variable would be 0.5. Thus, each brand contributed equally to the analyses regardless of the extent to which it was advertised. This is appropriate, because the objective of content analysis is to describe message content, not the effects of that content. In 2 analyses, trends in the frequency with which advertisements and brands were introduced during the decade were examined using the Statistical Package for Social Sciences curve fit procedure.²⁰

Results

After aggregating essentially identical advertisements, 320 remained for analysis, covering 101 brands Table 1. Sixty-eight percent of the brands were oral medications; 17% were topicals or transdermals; 7% required injections; 5% were inhalants; 2% were implants; and one brand (less than 1%) was a suppository.

Trends in DTC Advertising

The first set of research questions pertained to trends in DTC advertising. As shown in Table 1, the most common brands advertised were for dermatologic conditions, HIV/AIDS, cardiovascular disease, and obstetrical/gynecological conditions. Treatments for allergies, gastrointestinal conditions, musculoskeletal ailments, psychiatric/neurologic disorders, and urological conditions were also well represented. Brands for cancer, diabetes, infectious/non-HIV diseases, respiratory conditions, and tobacco addiction were less common.

We examined trends in the breadth of DTC advertising in 2 ways. First, to examine changes in the introduction of new brands, each of the 101 brands was classified under the calendar year in which it first appeared in the sampled publications. These data are reported in the first data series in the Figure 1, which shows a tendency for new brand introductions to increase during the 10-year period. Although brand introductions leveled off in 1996, the overall trend is best modeled as a linear relationship (adjusted R2=.80; B=2.03; P=.0003). Second, we classified each of the 320 advertisements under the calendar year in which it first appeared. These data are displayed in the second data series in the Figure 1. The number of new advertisement introductions grew from only 3 in 1989 to 76 in 1998. The best-fitting trend line for this increase is provided by a linear model (adjusted R2=.91; B=7.45; P <.0001).

Target Audiences

Our second set of questions concerned the kinds of consumers to which these advertisements are directed. Approximately 98% of the advertisements were judged as directed at the potential user of the drug; the remaining advertisements were aimed at third-party intermediaries (ie, the parent, spouse, or adult child of the potential patient). With regard to the sex of the targeted reader, 23% of the advertisements (18% of the brands) were judged as directed exclusively at women; 9% of advertisements (10% of the brands) were targeted exclusively to men; and 68% of advertisements (72% of the brands) were directed at both sexes.

Inducements

Our third set of questions addressed the nature of the inducements extended to consumers to encourage demand for the advertised pharmaceuticals. We examined 3 types of: patient support, information, and financial inducements. Patient support services were extended in only 3% of advertisements and 4% of brands.

Readers were offered additional printed information, such as free brochures or booklets in 34% of the advertisements (39% of brands). Audiotaped or videotaped information was available in 3% of the advertisements (6% of brands). Aggregating across format, 35% of advertisements (39% of brands) offered information in print or audio/video form. Offers of additional information were typically made available to the reader through a toll-free number.

With regard to monetary incentives, 13% of advertisements (9% of brands) offered a rebate or discount coupon. Only 1% of the advertisements provided a money-back guarantee; such a guarantee was extended at least once in the advertising campaigns for 3% of the brands. A total of 3% of the advertisements (4% of brands) offered a free sample of the product for the patient’s trial use. Of course, these inducements were available to patients through prescription only. Aggregating across these 3 monetary incentives, we found that 17% of the advertisements (17% of brands) offered at least one incentive.

Table 3 shows the percentage of advertisements that included patient support offers, information offers (in any format), and financial incentives (of any type) for each of the 14 medical condition categories. Virtually all patient support offers were extended in advertisements for tobacco cessation products. Information offers were most likely to be found in advertisements for cancer and tobacco addiction but were also common in advertisements for treatments of allergies and conditions of a cardiovascular, dermatologic, obstetric/gynecologic, and urological nature. Monetary inducements were found primarily in advertisements for treatments of allergies, dermatologic problems, and respiratory conditions.

Advertising Appeals

Finally, we examined the nature of appeals used in DTC advertisements. We initially examined the frequency with which each appeal was used across the 320 advertisements. Beginning with the most common appeal, the frequencies were: “effective” (57% of advertisements), “controls symptoms” and “innovative” (41% each), “prevents” condition (16%), “powerful” (9%), “reduced mortality” (7%), “dependable” (4%), and “cures” (3%). The percentage of advertisements using each of the social-psychological benefits claims was: “psychological enhancement” (11%), “lifestyle enhancement” (6%), and “social enhancement” (3%). The ease of use appeals were: “convenience” (38%), “quick acting” (6%), “economical” (5%), and “easy on system” (3%). The safety-related appeals were: “nonmedicated” (14%), “safe” (11%), “natural” (7%), and “not addictive” (5%).

We expected that the use of particular appeals would vary across the medical conditions treated by the promoted drugs. Using brand as the unit of analysis, 19 separate cross-tabulations were conducted, one for each appeal listed in Table 2 (therapeutic effectiveness, social-psychological benefits, ease of use, and safety-related), to examine the significance of association between medical condition category and the use of the appeal. Significant associations (P <.05) between the medical condition classification and appeal use were found for 7 of the appeals, for which adjusted standardized residuals were used to identify sources of significance. We organized these results around the medical condition categories for which an appeal was found to be significantly overrepresented or underrepresented.

Brands for allergy treatments were more likely to claim symptom control (100% of brands vs 41% of the total sample) and treatment without feelings of being medicated (88% vs 9%). Cancer and cardiovascular drugs were more likely to claim prolonged life as a benefit (100% and 20% of brands, respectively) than the total sample (6% of brands). In addition, cardiovascular treatments were more likely to offer economic benefits (40% of brands vs 6% for the entire sample), an effect largely attributable to comparative advertisements focusing on price. Three fourths of brands claiming to offer a powerful treatment fell into the HIV/AIDS category; 55% of those brands made such a claim compared with only 8% for all brands. HIV/AIDS brands were significantly less likely to claim symptom control as a benefit (9% of brands compared with 41% of all brands). Prevention was much more likely to be advanced in promotions for obstetric/gynecologic brands (60%, primarily contraceptives) and respiratory brands (67%) than the sample as a whole (17% of all brands). Respiratory brands were also more likely to claim symptom control as a benefit (100% vs 41% of the sample). Finally, respiratory treatments were more likely to make lifestyle-enhancement claims (67% vs 10% of all brands).

Discussion

The results of our study inform policy discussions on the appropriateness of DTC prescription drug advertising. Although content analyses of drug advertisements appearing in medical journals have been reported, our investigation is the first systematic content analysis of DTC drug advertisements. Similar to previous reports on advertising expenditures, our study reveals that DTC pharmaceutical marketing has increased substantially over the years. Furthermore, DTC advertising has been used to promote drugs for serious conditions; 30% of brands represented in the sample were for such life-threatening conditions as asthma, cancer, cardiovascular disease, diabetes, and HIV infection.

This dramatic increase underscores the need for research on the effects of DTC advertising on drug costs. It is still unclear whether such expenditures are passed on to the consumer through higher prices or promote competition that lowers prices.^21,22 We suspect that advertising-induced increases in demand for a drug may raise costs substantially when alternative treatments are not available or are substantially less effective. Conversely, promotion may spur competition on the basis of price within therapeutic categories when several treatment options are available. Of course, even expensive drugs can lower total health care expenditures if they provide effective treatment for costly conditions.

Although the breadth of prescription treatments advertised to consumers is impressive, the vast majority of drugs have not been promoted in this manner. Clearly, treatments for certain kinds of conditions are more likely to be advertised to consumers. Most of the drugs advertised are for common chronic conditions (approximately three fourths of the brands in Table 1. Drugs for conditions that may not be recognized as pathologic or treatable by consumers (eg, toenail fungus), under treated ailments (eg, hypertension, depression), and conditions not previously treatable with medication (eg, erectile dysfunction) are also well represented. Advertisements for treatments of acute conditions were rare (eg, antibiotics).

We also investigated the kind of inducements used to promote prescription drugs to consumers. The most common inducement was the offer of additional information. More than one third of the advertisers extended an invitation to the reader to request further information about the drug or condition in print or audio/video form. DTC advertising has often been justified on the grounds that it offers a valuable opportunity to educate the public about diseases and treatments. Future research should determine if these brochures and tapes provide quality education or simply try to sell the product.

Slightly less than 1 in 5 advertisements offered a monetary incentive to the reader for using the promoted drug. We believe that such incentives may be inappropriate when issued to people who have not had a diagnosis of the indicated condition.²³ These inducements also create the potential for antagonism between the patient who feels denied a bargain and the physician who believes that the drug is not indicated.

Our final objective was to describe the types of appeals used to sell prescription drugs to consumers. This analysis highlights areas in which the industry’s advertising requires careful monitoring. We are troubled, for instance, by the finding that two fifths of these advertisements made claims of “innovativeness.” Since advertisers often use “new and improved” claims to sell consumer products, it is not surprising that this heuristic phrasing is used to market pharmaceuticals. In truth, when it comes to drugs, what is new is not necessarily better. Most new drugs offer few advantages over older drugs and have less understood safety profiles.

Also of concern is the infrequency with which appeals to cost savings are used. Such appeals were found in only 1 out of every 20 advertisements. The provision of price information, including comparisons of costs with competing drugs, has been mentioned as one mechanism by which price competition could be fostered. We question whether such comparisons would improve the economic and physical health of patients but believe it is disingenuous for proponents of DTC advertising to advance this argument when cost information is seldom provided.

Limitations

Our study has limitations. Most notably, content analysis by its very nature seeks to explicate message form and content, not message effects. Policy discussions must be based on careful analyses of what the drug industry is telling consumers, but such analyses need to be augmented with data that show the effects of DTC advertising on patients’ drug information-seeking, physicians’ prescribing decisions, and ultimately on health outcomes. We also focused exclusively on the text of these advertisements; visual arguments are often used in advertising, including DTC drug advertising.²⁴ Finally, our sample was restricted to advertisements appearing in US magazines.

Conclusions

The pharmaceutical industry has turned to consumer-targeted prescription drug advertising to increase Americans’ demand for many of its products. If the current trend continues, such advertising could become the major source of information through which consumers learn about prescription drugs. As such, it is imperative that family physicians take an occasional look at the magazines in their own offices to keep abreast of the specific drugs being promoted to their patients. If DTC advertising is to be regulated properly, there is much we will need to learn about how these advertisements are influencing consumers and what impact they have on the physician-patient relationship

Acknowledgments

The authors wish to acknowledge the contributions made by Ronald Emerick, Robert LaGreca, Love Lord, and Sarah Shaw in the collection and coding of advertisements.

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals in the United States is a fast-growing, much-heralded, and important phenomenon. The purpose of this type of advertising is to induce consumers to request prescriptions from their physicians, usually from their primary care physician.¹ The amount of money the pharmaceutical industry spends annually on DTC advertising is expected to quadruple current levels during the next few years and may approach $7.5 billion by 2005.^2,3 Regulatory oversight of this form of advertising has been the responsibility of the US Food and Drug Administration (FDA) since 1962.⁴ Historically, the industry’s advertising has been placed in medical journals. However, in the early 1980s several companies began to promote their drugs directly to consumers. The FDA obtained a voluntary moratorium on this type of advertising in 1983, which was then lifted in 1985.⁵

Despite the FDA’s green light, the industry did not resume advertising to consumers in earnest until 1990. Regulations have dictated that a DTC advertisement must include a brief summary of indications, side effects, and contraindications.⁶ As a result, advertisements were initially placed primarily in magazines and newspapers, because it was difficult to fulfill the brief summary requirement in a broadcast advertisement.⁷ This requirement was relaxed in 1997, leading to the recent emergence of DTC advertisements on television.⁸

Members of the medical profession have editorialized on the promise^9,10 and pitfalls¹¹ of DTC advertising. Disputes have focused on issues such as whether this type of advertising simultaneously informs and influences consumers,¹² enhances or worsens health outcomes,^13,14 leads to the treatment of underserved patients or to an overmedicated society,¹⁵ improves or hurts the physician-patient relationship,¹⁶ and educates or confuses the consumer.¹⁷ We seek to improve the quality of this policy debate through a descriptive analysis of the content of prescription drug promotions that have appeared in popular US magazines from 1989 to 1998.

Our study addresses 4 sets of concerns. First, we examine trends in the breadth of DTC advertising to augment available data on advertising expenditures. We also profile the medical conditions for which advertising has been used, because viewpoints about the appropriateness of DTC promotion sometimes have as their premise assumptions about the seriousness of the conditions for which drugs are advertised.¹⁸ Second, we examine the intended target of these advertisements to better understand the promotional strategies of the drug industry. Third, we describe the inducements offered to readers to promote demand for drugs. Fourth, we document the advertising appeals used to enhance a patient’s interest in the drugs, including selling points pertaining to the promoted drug’s effectiveness, social-psychological benefits, safety, and ease of use. In all likelihood, these appeals provide patients with motivation to request prescriptions and with arguments to present to the family physician.

Methods

Sampling Procedure

Advertisements were collected from 18 diverse magazines. Based on the annual reports of the market research firm CMR, leading American consumer magazines were ranked in terms of the average number of advertising pages sold from 1989 through 1996 (the last year for which data were available at the commencement of our project). The magazines were then stratified according to the classifications reported in Magazines for Libraries.¹⁹ The highest-ranked publication within each of the following 13 categories was selected for inclusion in our sample: business (Business Week), fishing/hunting/guns (Field & Stream), food/wine (Gourmet), home (Better Homes and Gardens), men (GQ), music (Rolling Stone), news and opinion (Time), parenting (Parents), personal finance (Money Magazine), sports (Sports Illustrated), tabloid/general editorial (Reader’s Digest), women (Vogue), and medicine/health (Prevention). To these magazines we added 5 publications targeted to narrower segments of the population defined by ethnicity (Ebony and Hispanic), age (Modern Maturity and New Choices for Best Years), and sexual orientation (The Advocate). With the exception of promotions for HIV treatments, which usually appeared in The Advocate, most of the advertisements in these supplemental publications were also found in the primary sample of magazines.

All product-specific prescription drug advertisements appearing in these magazines from January 1989 through December 1998 were photocopied. We excluded disease education messages that did not mention a specific drug and advertisements for medical devices and veterinary drugs. Advertisements for the same brand often differed in nonsubstantive ways and were coded as a single case.*

Two judges independently coded each advertisement. To maximize reliability, almost all codes involved a determination of the presence or absence of a word or phrase in the advertisement. The mean kappa across all classifications reported here was .93 (range=0.90-1.0).

Classifications

Medical conditions. We classified each drug brand into 1 of 14 medical condition categories Table 1. In most cases, this was a straightforward process; however, when a drug was promoted for more than one indication it was classified according to the indication for which it was most extensively advertised.

Inducements. The advertisements were coded for the presence or absence of an offer of each of the following inducements: patient support services (eg, assistance in helping the reader find a local support group for smoking cessation), additional information about the drug or condition in print or audiotape/video form, and monetary incentives (rebate, discount coupon, money-back guarantee, or free product trial).

Advertising appeals. Each advertisement wascoded for the presence or absence of a number of inductively derived claims about the drug’s effectiveness, social-psychological benefits, ease of use, and safety. We looked at whether each of 42 adjectives, adjectival phrases, or adverbs was used to describe the drug’s nature or impact. We initially coded for the presence or absence of each of these terms or phrases and then collapsed across related claims to create more general product attribute variables as shown in Table 2. For instance, to create the attribute category “Innovative,” we coded for the terms “advancement,” “breakthrough,” “a first,” the “only” drug of kind, “innovative,” “novel,” and “new” and then recoded each advertisement for whether at least one of these descriptors was used to depict the drug.

Statistical Analyses

We employed 2 units of analysis. In most instances, the unit of analysis was the advertisement, with descriptive statistics serving as the primary analytic tool. Use of the advertisement as the unit of analysis, however, is inappropriate when inferential tests such as the chi square are used. Doing so would violate the assumption of independence of observations, because most advertisements for a brand represent modifications of previously placed advertisements. We thus relied on the brand as the unit of analysis when using inferential statistical procedures. Specifically, each brand was treated as a single case by giving each advertisement for the brand a weight of 1/n, when n represents the number of advertisements for that brand. For instance, if 5 advertisements were found for a particular brand, each advertisement was given a weight of 0.2 in these analyses. This approach allows for fractional values on the coded variables. For example, if half the advertisements for a brand provided a monetary incentive, the value for the brand on that variable would be 0.5. Thus, each brand contributed equally to the analyses regardless of the extent to which it was advertised. This is appropriate, because the objective of content analysis is to describe message content, not the effects of that content. In 2 analyses, trends in the frequency with which advertisements and brands were introduced during the decade were examined using the Statistical Package for Social Sciences curve fit procedure.²⁰

Results

After aggregating essentially identical advertisements, 320 remained for analysis, covering 101 brands Table 1. Sixty-eight percent of the brands were oral medications; 17% were topicals or transdermals; 7% required injections; 5% were inhalants; 2% were implants; and one brand (less than 1%) was a suppository.

Trends in DTC Advertising

The first set of research questions pertained to trends in DTC advertising. As shown in Table 1, the most common brands advertised were for dermatologic conditions, HIV/AIDS, cardiovascular disease, and obstetrical/gynecological conditions. Treatments for allergies, gastrointestinal conditions, musculoskeletal ailments, psychiatric/neurologic disorders, and urological conditions were also well represented. Brands for cancer, diabetes, infectious/non-HIV diseases, respiratory conditions, and tobacco addiction were less common.

We examined trends in the breadth of DTC advertising in 2 ways. First, to examine changes in the introduction of new brands, each of the 101 brands was classified under the calendar year in which it first appeared in the sampled publications. These data are reported in the first data series in the Figure 1, which shows a tendency for new brand introductions to increase during the 10-year period. Although brand introductions leveled off in 1996, the overall trend is best modeled as a linear relationship (adjusted R2=.80; B=2.03; P=.0003). Second, we classified each of the 320 advertisements under the calendar year in which it first appeared. These data are displayed in the second data series in the Figure 1. The number of new advertisement introductions grew from only 3 in 1989 to 76 in 1998. The best-fitting trend line for this increase is provided by a linear model (adjusted R2=.91; B=7.45; P <.0001).

Target Audiences

Our second set of questions concerned the kinds of consumers to which these advertisements are directed. Approximately 98% of the advertisements were judged as directed at the potential user of the drug; the remaining advertisements were aimed at third-party intermediaries (ie, the parent, spouse, or adult child of the potential patient). With regard to the sex of the targeted reader, 23% of the advertisements (18% of the brands) were judged as directed exclusively at women; 9% of advertisements (10% of the brands) were targeted exclusively to men; and 68% of advertisements (72% of the brands) were directed at both sexes.

Inducements

Our third set of questions addressed the nature of the inducements extended to consumers to encourage demand for the advertised pharmaceuticals. We examined 3 types of: patient support, information, and financial inducements. Patient support services were extended in only 3% of advertisements and 4% of brands.

Readers were offered additional printed information, such as free brochures or booklets in 34% of the advertisements (39% of brands). Audiotaped or videotaped information was available in 3% of the advertisements (6% of brands). Aggregating across format, 35% of advertisements (39% of brands) offered information in print or audio/video form. Offers of additional information were typically made available to the reader through a toll-free number.

With regard to monetary incentives, 13% of advertisements (9% of brands) offered a rebate or discount coupon. Only 1% of the advertisements provided a money-back guarantee; such a guarantee was extended at least once in the advertising campaigns for 3% of the brands. A total of 3% of the advertisements (4% of brands) offered a free sample of the product for the patient’s trial use. Of course, these inducements were available to patients through prescription only. Aggregating across these 3 monetary incentives, we found that 17% of the advertisements (17% of brands) offered at least one incentive.

Table 3 shows the percentage of advertisements that included patient support offers, information offers (in any format), and financial incentives (of any type) for each of the 14 medical condition categories. Virtually all patient support offers were extended in advertisements for tobacco cessation products. Information offers were most likely to be found in advertisements for cancer and tobacco addiction but were also common in advertisements for treatments of allergies and conditions of a cardiovascular, dermatologic, obstetric/gynecologic, and urological nature. Monetary inducements were found primarily in advertisements for treatments of allergies, dermatologic problems, and respiratory conditions.

Advertising Appeals

Finally, we examined the nature of appeals used in DTC advertisements. We initially examined the frequency with which each appeal was used across the 320 advertisements. Beginning with the most common appeal, the frequencies were: “effective” (57% of advertisements), “controls symptoms” and “innovative” (41% each), “prevents” condition (16%), “powerful” (9%), “reduced mortality” (7%), “dependable” (4%), and “cures” (3%). The percentage of advertisements using each of the social-psychological benefits claims was: “psychological enhancement” (11%), “lifestyle enhancement” (6%), and “social enhancement” (3%). The ease of use appeals were: “convenience” (38%), “quick acting” (6%), “economical” (5%), and “easy on system” (3%). The safety-related appeals were: “nonmedicated” (14%), “safe” (11%), “natural” (7%), and “not addictive” (5%).

We expected that the use of particular appeals would vary across the medical conditions treated by the promoted drugs. Using brand as the unit of analysis, 19 separate cross-tabulations were conducted, one for each appeal listed in Table 2 (therapeutic effectiveness, social-psychological benefits, ease of use, and safety-related), to examine the significance of association between medical condition category and the use of the appeal. Significant associations (P <.05) between the medical condition classification and appeal use were found for 7 of the appeals, for which adjusted standardized residuals were used to identify sources of significance. We organized these results around the medical condition categories for which an appeal was found to be significantly overrepresented or underrepresented.

Brands for allergy treatments were more likely to claim symptom control (100% of brands vs 41% of the total sample) and treatment without feelings of being medicated (88% vs 9%). Cancer and cardiovascular drugs were more likely to claim prolonged life as a benefit (100% and 20% of brands, respectively) than the total sample (6% of brands). In addition, cardiovascular treatments were more likely to offer economic benefits (40% of brands vs 6% for the entire sample), an effect largely attributable to comparative advertisements focusing on price. Three fourths of brands claiming to offer a powerful treatment fell into the HIV/AIDS category; 55% of those brands made such a claim compared with only 8% for all brands. HIV/AIDS brands were significantly less likely to claim symptom control as a benefit (9% of brands compared with 41% of all brands). Prevention was much more likely to be advanced in promotions for obstetric/gynecologic brands (60%, primarily contraceptives) and respiratory brands (67%) than the sample as a whole (17% of all brands). Respiratory brands were also more likely to claim symptom control as a benefit (100% vs 41% of the sample). Finally, respiratory treatments were more likely to make lifestyle-enhancement claims (67% vs 10% of all brands).

Discussion

The results of our study inform policy discussions on the appropriateness of DTC prescription drug advertising. Although content analyses of drug advertisements appearing in medical journals have been reported, our investigation is the first systematic content analysis of DTC drug advertisements. Similar to previous reports on advertising expenditures, our study reveals that DTC pharmaceutical marketing has increased substantially over the years. Furthermore, DTC advertising has been used to promote drugs for serious conditions; 30% of brands represented in the sample were for such life-threatening conditions as asthma, cancer, cardiovascular disease, diabetes, and HIV infection.

This dramatic increase underscores the need for research on the effects of DTC advertising on drug costs. It is still unclear whether such expenditures are passed on to the consumer through higher prices or promote competition that lowers prices.^21,22 We suspect that advertising-induced increases in demand for a drug may raise costs substantially when alternative treatments are not available or are substantially less effective. Conversely, promotion may spur competition on the basis of price within therapeutic categories when several treatment options are available. Of course, even expensive drugs can lower total health care expenditures if they provide effective treatment for costly conditions.

Although the breadth of prescription treatments advertised to consumers is impressive, the vast majority of drugs have not been promoted in this manner. Clearly, treatments for certain kinds of conditions are more likely to be advertised to consumers. Most of the drugs advertised are for common chronic conditions (approximately three fourths of the brands in Table 1. Drugs for conditions that may not be recognized as pathologic or treatable by consumers (eg, toenail fungus), under treated ailments (eg, hypertension, depression), and conditions not previously treatable with medication (eg, erectile dysfunction) are also well represented. Advertisements for treatments of acute conditions were rare (eg, antibiotics).

We also investigated the kind of inducements used to promote prescription drugs to consumers. The most common inducement was the offer of additional information. More than one third of the advertisers extended an invitation to the reader to request further information about the drug or condition in print or audio/video form. DTC advertising has often been justified on the grounds that it offers a valuable opportunity to educate the public about diseases and treatments. Future research should determine if these brochures and tapes provide quality education or simply try to sell the product.

Slightly less than 1 in 5 advertisements offered a monetary incentive to the reader for using the promoted drug. We believe that such incentives may be inappropriate when issued to people who have not had a diagnosis of the indicated condition.²³ These inducements also create the potential for antagonism between the patient who feels denied a bargain and the physician who believes that the drug is not indicated.

Our final objective was to describe the types of appeals used to sell prescription drugs to consumers. This analysis highlights areas in which the industry’s advertising requires careful monitoring. We are troubled, for instance, by the finding that two fifths of these advertisements made claims of “innovativeness.” Since advertisers often use “new and improved” claims to sell consumer products, it is not surprising that this heuristic phrasing is used to market pharmaceuticals. In truth, when it comes to drugs, what is new is not necessarily better. Most new drugs offer few advantages over older drugs and have less understood safety profiles.

Also of concern is the infrequency with which appeals to cost savings are used. Such appeals were found in only 1 out of every 20 advertisements. The provision of price information, including comparisons of costs with competing drugs, has been mentioned as one mechanism by which price competition could be fostered. We question whether such comparisons would improve the economic and physical health of patients but believe it is disingenuous for proponents of DTC advertising to advance this argument when cost information is seldom provided.

Limitations

Our study has limitations. Most notably, content analysis by its very nature seeks to explicate message form and content, not message effects. Policy discussions must be based on careful analyses of what the drug industry is telling consumers, but such analyses need to be augmented with data that show the effects of DTC advertising on patients’ drug information-seeking, physicians’ prescribing decisions, and ultimately on health outcomes. We also focused exclusively on the text of these advertisements; visual arguments are often used in advertising, including DTC drug advertising.²⁴ Finally, our sample was restricted to advertisements appearing in US magazines.

Conclusions

The pharmaceutical industry has turned to consumer-targeted prescription drug advertising to increase Americans’ demand for many of its products. If the current trend continues, such advertising could become the major source of information through which consumers learn about prescription drugs. As such, it is imperative that family physicians take an occasional look at the magazines in their own offices to keep abreast of the specific drugs being promoted to their patients. If DTC advertising is to be regulated properly, there is much we will need to learn about how these advertisements are influencing consumers and what impact they have on the physician-patient relationship

Acknowledgments

The authors wish to acknowledge the contributions made by Ronald Emerick, Robert LaGreca, Love Lord, and Sarah Shaw in the collection and coding of advertisements.