The Relationship between Direct-to-Consumer Prescription

Drug Advertising and Prescription Rates

Elizabeth Ann Almasi Department of Economics

Stanford University

Advisor: Jay Bhattacharya*

May 2006

Abstract: Direct-to-consumer advertising (DTCA) has been a contentious issue ever since its introduction in the 1990s. Many in the medical field have suggested that DTCA misleads consumers, and causes them to demand prescriptions for newer, more expensive medications when older drugs, proven to be safe, would be just as effective. Proponents, however, suggest that DTC (direct-to-consumer) advertisements increase patients’ awareness of available therapies, their adherence to treatments, and their likelihood of discussing medical conditions with physicians. In this paper I write the first systematic review, to my knowledge, of the literature on DTC advertising. Then I examine how the quality of DTC advertisements affects prescription rates. To determine the quality of a prescription drug advertisement I created a tool in collaboration with the Food and Drug Administration (FDA) which quantifies the content of the risk and benefit information and the presentation of the aforementioned information. I found a significant correlation between certain quality characteristics of DTC advertisements and prescription rates. I introduce the concept of the effective advertising expenditure (EAE) to predict the advertising expenditures per prescription. The advertising cost per new, refill, and total prescriptions is estimated with remarkable accuracy using the EAE for five drugs sales between 1999 and 2004. Implications of the effective advertising expenditures for drug companies and FDA regulators are also discussed. * I would like to thank Jay Bhattacharya for his tremendous support as my freshman and economics advisor, without him this project would not be possible. I would also like to thank Randall Stafford for his exceptional mentorship as my research advisor over the past three years and invaluable assistance with data collection. Special thanks go to Nancy Ostrove for kindly introducing me to the regulatory process and her insightful comments on the DTC Assessment. I would also like to thank Robert Sensenbrenner for lending his editing acumen to my paper. I am incredibly grateful to the Buck Foundation for the scholarship they bestowed on me during my education. Finally, thanks to the Undergraduate Research Programs at Stanford University for their financial support and Geoffrey Rothwell for his guidance throughout the thesis writing process.

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Table of Contents 1. Introduction 2. History of the Regulation of Prescription Drug Advertising and the Role of the Food and Drug Administration (FDA) 3. The Debate Over DTCA

3.1 Impact of DTCA on Prescriptions 3.2 DTC Advertising Mediums 3.3 Characteristics of Drugs that Employ DTCA 3.4 Characteristics of Prescription Drug Advertisements 3.5 Factors that Influence Consumer’s Awareness of Prescription Drug Ads 3.6 Viewers’ Recall of Prescription Drug Advertisements 3.7 Consumers’ Opinion of DTCA 3.8 Misconceptions Surrounding the Regulation of DTCA 3.9 Doctors Response to Patient Expectation

3.10 Physician-Patient Relationship and Patient Satisfaction 3.11 Increased Efficacy of Medication through DTCA Mediated Placebo Effects 3.12 Compliance 3.13 Medicalizing 3.14 Costs of DTCA 4. Study Design

4.1 Methodology for Rating Quality of Advertisements: The DTC Assessment

4.2 Presentation Assessment 4.3 Content Assessment 4.4 Data 4.5 Data Analysis 5. Results

5.1 DTCA Expenditures 5.2 Prescription Rates 5.3 Relationship Between DTCA Expenditures and Prescriptions 5.4 Advertisement Quality Scores 5.5 Factor Analysis

5.6 Advertising Quality and Prescription Rates 5.7 Effective Advertising Expenditures 5.8 Advertising Quality and DTCA Expenditures

6. Discussion 7. Appendix

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1. Introduction

“Advertisements contain the only truth to be relied on in a newspaper.” – Thomas Jefferson

“Advertising is a racket….its constructive contribution to humanity is exactly minus zero.”

– F. Scott Fitzgerald Since the Food and Drug Administration relaxed its guidelines for DTCA in 1997, the

rate of expenditures for U.S. DTC promotion of prescription medication has risen more than

500% from US$791 million in 1996, to more than US$4.0 billion in 2004. According to Pinto

(1998), DTC advertising has become a popular means of disseminating information for several

reasons: physicians operating in managed care organizations no longer have the time or

opportunity to interact directly with pharmaceutical representatives driving a need for a new

form of advertising. Growth in the number of drugs available has also made it difficult for

physicians to stay up-to-date with current alternatives, increasing the need for informational

advertising. Finally, the baby boomers seek information from advertising as they take a more

active role in their health care. Over the past few years, DTC advertising has been very effective

at increasing the number of prescriptions for advertised drugs. According to the U.S.

Government Accounting Office, prescriptions for drugs heavily advertised to consumers

increased six times more rapidly than prescriptions for other drugs.

Studies by Rosenthal et al (2003) suggest that the marketing elasticity of demand for

DTCA ranges from 0.096 to 0.114, meaning a 10% increase in DTCA leads to a 1% increase in

sales when all else is equal. In the proton pump inhibitor class, which contains medications for

heartburn, sales increased 36% from $4.2 billion in 1998 to $5.7 billion in 1999. This

corresponded with a 60% increase in spending on DTCA from $49.7 million to $80.1 million,

which led to a 6 percentage point growth in the market when a 0.10 elasticity of demand is

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applied. This 17% increase in sales resulting from advertising, which equates to $252 million,

gives a return of 8.3 times the investment on DTC spending ($30.4 million). According to Berndt

(2005), “industry officials have suggested…that their target changes in sales are in the range of

four to five times the change in DTCA spending at the brand level.” These results have been

achieved for marketing efforts in 1999 and 2000. In this time period, 12% of the growth in total

prescription drug spending, or $2.6 billion, can be attributed to DTCA, yielding $4.20 for every

dollar spent on DTC advertising (Rosenthal et al, 2003).

Few studies have been conducted on the marketing elasticity of DTC advertising in

particular, but work by Hurwitz and Caves (1988), Rizzo (1999), Coscelli (2000), and Vogt and

Bhattacharya (2003) all suggest that advertising to physicians has caused the pharmaceutical

market to be “sticky” and reduce the competition between medications within a drug class.

However, many authors have begun to note, as did Leffler in the 1980s, that:

“economic analysis generally treats advertising as a homogeneous activity that is evaluated independently of why it might increase demand. Yet advertising’s effects need not be the same in different markets or in different setting within a market….Both positive and normative analysis should therefore be prefaced by the particulars of the products advertised, the message delivered, and the buyers addressed.”

Rizzo (1999) also suggests that the “effects of advertising hinge on the nature of the advertising

and information conditions in the market.” The following study aims to build upon the empirical

work conducted within submarkets where advertising was considered homogenous, by

measuring the quality of the advertisement and correlating it to the number of prescriptions for

on advertised drugs.

It is important to understand how the quality of the advertisements impact new

prescriptions from both an economic and a health policy perspective. Economically,

prescriptions for new medications are one of the leading causes of the rise in health care costs.

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From a policy perspective, it is essential that patients are given the most pertinent information

when making health care decisions so the best health outcomes are achieved. Berger et al (2001)

suggest that patient expectation and physician perception of patient expectation for a prescription

medication correlate with the issuance of a prescription. Since physicians at least partially

acceded to 69% of inappropriate DTC requests, or 19% of all DTCA requests, it is critical to

appreciate the expectations patients develop through DTC advertisements (Murray et al, 2004).

Heightened expectations may lead to inappropriate and costly demands for medications when

evidence would dictate other medications or non-pharmacological interventions should be used.

Determining the information and presentation formats patients are most receptive to could help

regulators write the most socially beneficial guidelines.

This purpose of this study is to:

a) Develop a tool to quantify the quality of prescription drug advertisements using

different content and presentation criteria

b) Determine which characteristics are most significant in increasing prescription rates

c) Develop a model to explain the fluctuation in prescription rates (new, refill, and

total) as a function of the quality and quantity of DTC advertising

By understanding how certain advertisement characteristics affect prescription rates, drug

companies may create better advertisements to achieve the maximum impact of their advertising

expenditures, while FDA regulators may place greater emphasis on certain information or

presentation characteristics as they revise the current guidelines regarding DTC advertising to

achieve the maximum social benefit from DTCA.

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2. History of the Regulation of Prescription Drug Advertising and the Role of the Food and Drug Administration (FDA)

Though medicines were one of the first products to be advertised in print form,

regulations of these messages has changed drastically in recent years. A German news book from

1591 contained the first print advertisement: a promotion of “first puff”, a mysterious and

wonderful curative herb (Leffler, 1981). Regulation of medical advertising began in 1736 in the

colony of Virginia, which required that the label of a medicine specify its ingredients.

Through the 1800s, pharmacists mixed ingredients together from standard ingredients

which allowed them not only to advise patients, but also ensure the quality of their products. By

1880, advances in technology allowed large-scale mixing, forming, and bottling of tablets, which

transformed the pharmaceutical industry. The manufactures, who could ensure homogenous,

high quality products, began to advertise to capitalize on their brand name. This led to an over

exaggeration of product claims, forcing the government to pass the first Food, Drug, and

Cosmetic Act in 1906, which allowed the Bureau of Chemistry in the Department of Agriculture

to monitor compliance with labeling standards.

The Bureau attempted to take action against false therapeutic claims, but, in 1911, the

Supreme Court ruled in the case United States v. Johnson that labeling provisions could not be

extended to efficacy. In response, the government passed the Federal Trade Commission Act in

1914, however, the Supreme Court ruled that this act could only be used against false claims that

injured present or potential competitors, not to prevent injuries to consumers from false claims.

The loopholes in the FTC and Food, Drug, and Cosmetic Act regulations were eventually

closed in 1938 under the Wheeler-Lea amendment to the FTC act, which prohibited false

advertising that resulted in the sale of products harmful to the health consumers. The FTC

continued to monitor false advertising, while the newly created FDA was responsible for

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reviewing warnings on drug labels. The FDA interpreted this legislation to mean that all labeling

written in consumer friendly language was to be prohibited. This interpretation by the FDA

placed many over-the-counter (OTC) medications in violation of labeling requirements, forcing

many of the OTC drugs to revert to prescription only use. This move effectively usurped the

FTC’s jurisdiction over medical advertising, as the FDA expanded its monitoring to all labeling

and promotional materials to physicians, and essentially prohibited advertising to consumers.

In 1958, the Senate began to investigate promotion of pharmaceuticals to physicians

through detailing (a form advertising in which drug company representatives visit doctors’

offices). Many claimed detailing was misleading, uninformative, and responsible for the high

price of drugs. This led to the Food, Drug, and Cosmetic Act of 1962, also known as the

Kefauver amendments, which required all drug promotion materials to include a prominent

display of the chemical name, quantities of composition, side effects, contraindications, and

effectiveness. Thus, detailing to physicians became officially regulated by the FDA.

Between the 1960s and 1980s, the FDA created requirements for pharmaceutical

advertising directed towards physicians. All “product claim” advertisements (advertisements that

recommend a drug for a particular disease or condition) must:

1) present a “fair balance” of risk and benefit information

2) contain a “brief summary” which must include the indication of the drug, warnings,

adverse reactions, contraindications, and overdose information

Advertising toward physicians has increased steadily ever since 1960. In 1981, Eli Lilly

surprised the health care community by launching a campaign for its new anti-arthritic drug,

Oraflex, to both physicians and consumers. The advertisements suggested that the Oraflex could

stop the progression of arthritis. This message influenced the public, as the number of

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prescriptions for Oraflex rose from 2,000 to 55,000 in the course of five months. However, after

the course of five months Eli Lilly removed Orafelx from the market as reports emerged

concerning severe side effects, including death. In response, the FDA commissioner, Arthur

Hayes, requested that pharmaceutical companies institute a moratorium on DTC advertising

while the agency examined the effects of pharmaceutical advertising directly to consumers.

After several studies, the FDA lifted the moratorium on advertising through a Federal

Register notice in 1985 that states guidelines in place for physician-direct marketing serve as

“sufficient safeguards to protect consumers.” Shortly after, print advertisements for

pharmaceuticals began to appear in magazines and newspapers. However, the “brief summary,”

which described all the risk information, was often quite long and difficult for consumers to read.

Furthermore, the length of the brief summary was far too long to present within a 30-second TV

spot. Therefore, pharmaceutical companies resorted to using the two other forms of

advertisements approved by the FDA towards physicians: “reminder ads”, which mention a

drugs name without the indication (a medical term that refers to the disease that the drug treats);

or “help-seeking” ads, which describe the disease the drug treats without mentioning the name of

the product. The “reminder ads” were pertinent to physicians who were familiar with the drug,

however consumers with no prior knowledge were often confused.

In 1997, the FDA issued new guidelines to rectify this problem, allowing DTC

advertisements to mention the brand name and condition that a drug treats without revealing all

the risk information. Instead, the product claims must include a “major statement,” which

consists of the most severe side effects, the most common side effects, contraindications (a

medical term that refers to the drug combinations that would which would lead to drug-drug

interactions), and warnings. The advertisement must also include an “adequate provision” for

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consumers to obtain more information about a drug. Specifically, the advertisement must include

the following:

1) toll-free telephone number to receive additional drug information via mail, fax, or phone

2) website address 3) reference to a print advertisement concurrently running in print publication 4) referral to a health care provider (i.e. physician or pharmacist)

Many question the efficacy of this regulatory structure for direct-to-consumer pharmaceutical

advertising. The FDA is still actively refining the guidelines surrounding DTC advertising. In

January 2004, the FDA issued a draft guidance to further refine the “brief summary” that must be

included with all print advertisements. To fulfill this requirement, pharmaceutical companies

often included the complete risk-related sections of the FDA- approved labeling directed towards

physicians. According to the Draft Guidance, “This information is often presented verbatim, in

small type. Because this labeling is written for an audience of health care practitioners, it uses

highly technical medical terminology. In addition….[labeling] includes all possible adverse

events, including those that are unlikely to be drug related.” According to the FDA, this

abundance of highly technical information can make it difficult for consumers to comprehend the

risk information. Therefore, they propose that the brief summary be written in a “highlight”

format, which includes the following information in consumer-friendly language:

1) All contraindications,

2) All warnings,

3) Most serious side effects and precautions,

4) 3-5 most common side effects.

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Many DTC advertisements have begun to include this “highlights” section, making the risk

information much more accessible to consumers.

Since the modification of FDA requirements in 1997, the sudden surge in DTC

advertising has caused a large controversy in the medical community. Many claim that the

regulations are not stringent enough to protect consumers, while others suggest that the

regulations make the advertisements cumbersome. The FDA continues to research the effect of

DTC advertising, as well as the potential brief summary formats that may increase the overall

effectiveness of DTCA. Given the personal nature of healthcare and the rising costs of

pharmaceuticals, DTC advertising will continue to be a contentious issue among physicians and

policymakers.

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3. The Debate Over DTC Advertising

“I think I was wrong…On the whole I think there is a lot of educational benefit [to direct-to-consumer drug advertising].” – David K. Kessler, former FDA Commissioner

“[DTC Advertising] is supposed to get patients who need the medication to know about the drug

so they can ask their physician about it…Direct-to-consumer advertising correctly done is a great public health tool… We now have ads on television that show people walking through

meadows as the name is subliminally flashed, and there are birds singing and bees copulating…We’ve got to cut that out, because that is not what direct-to-consumer advertising is

supposed to be.” – Lester Crawford, former FDA Commissioner

Besides former FDA commissioners, many disagree about the beneficial and harmful

consequences of DTC advertisements. Proponents of DTCA claim that advertisements increase

patients’ awareness of available therapies, reduce the stigma of talking to their physician about

certain conditions, increases patient confidence, and increase patients adherence to therapies.

Overall, they believe the educational content of these messages helps target conditions that are

under-treated, such as depression and high cholesterol (hyperlipedimia), while also increasing

compliance of patients who have already received a prescription.

Opponents of DTCA generally recognize these useful properties of advertising, but

question “whether the advertisements contain and communicate drug information in a manner

that is best suited for consumers” (Roth, 1996). They object to the motives of advertising, which

they claim place a higher value on increased sales revenue rather than optimal health care.

Opponents often complain that DTC advertisements strain the physician-patient relationship and

cause physicians to spend extra time persuading patients that certain DTCA drugs are

inappropriate for them. Moreover, the advertisements may increase demand for more expensive

or unnecessary drugs, and even lead to the prescription of inappropriate medications.

The emotional appeals in DTCA make vivid impressions on viewers. These impressions

may cause patients to form expectations about the condition and the medication advertised.

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Heightened expectations of the drug may encourage people to visit their doctor and treat

conditions that had gone unnoticed. It may also improve compliance with recommended

therapies and hasten the uptake of revolutionary new drugs. Almasi et al (2006) purposed that

heightened expectations may actually lead to an increase in the efficacy of advertised

medications through the placebo effect. Heightened expectations created by prescription drug

advertisements may have many beneficial effects on the initiation and delivery of health care.

Heightened expectations, however, may also lead patients to demand inappropriate drugs,

which could cause a strain in the physician-patient relationship as doctors break down the

generated expectancy. Studies show new prescriptions are correlated with patient expectation

and the physician’s perception of patient expectation (Berger et al, 2001). Therefore, opponents

of DTCA are well founded in their belief that the incorrect expectations created by these

advertisements leads to inappropriate prescribing practices.

This effect may be exacerbated by the lack of benefit and risk information available in

most advertisements to create well-informed expectations. Persuasive advertisements lead to a

large increase in demand for relatively unproven drugs that have only recently become available.

The Vioxx and Phen-Fen debacles have shown us that many side-effects do not emerge within

the first few years the product is on the market. Some argue that by expanding the number of

patients taking the drug during this uncertain period, a larger patient population is at risk to

unknown side effects. Furthermore, some have argued that DTCA encourages people to seek

medical solutions to normal human experiences, and thus driving the cost of health care. These

are serious concerns, and governments must weigh this harm against the potential benefits of

DTC advertising.

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DTCA is a contentious issue throughout the world. The United States and New Zealand

are the only two nations which allow DTC advertising. In 2002, the European Parliament

rejected the latest proposal to allow DTC advertising for drugs used to treat asthma, AIDS, and

diabetes. Similarly, in 2004, the Canadian parliament recommended against DTC advertising

because “Drug advertisements could endanger rather than empower consumers by minimizing

risk information and exaggerating benefits [and] could contribute to increased or inappropriate

drug consumptions” (Mansfield et al, 2005). In 2002, New Zealand was also considering a ban

on DTCA: “New Zealand’s health minister, Anette King, has taken the advice of New Zealand’s

health professional and consumer groups and has decided that the potential benefits of DTCA do

not justify the harms and so plans to ban it” (Mansfield et al, 2005). However, the changing

political climate in New Zealand makes any prohibition of DTCA seem unlikely in the near

future. This issue remains at the forefront of the debate about pharmaceuticals around the world.

The Food and Drug Administration maintains that there is a beneficial role for this type

of promotion when it is done appropriately. Studies by the FDA and others support this position;

however, there are also many negative externalities which could be reduced through better

regulation.

3.1 Impact of DTCA on Prescriptions

Consumers have become more aware of DTC advertising in recent years. A study by the

Kaiser Family Foundation (2005) showed that 90% of adults have seen or heard advertisements

for prescription medications in 2005, up from 79% in 2000. Many of these advertisements have

been well targeted: 20% of consumers have seen an advertisement that was relevant to their

health in the past twelve months. Not surprisingly, patients who are taking a prescription

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medication are more likely to recall advertisements, because the information in the

advertisements is more pertinent to these patients than the average consumer (Murray et al,

2004). Advertisements are recalled at the highest rate by patients suffering from allergies,

osteoporosis, hypertension, or arthritis, which have therapies that are highly advertised through

DTCA. Despite the fact that consumers ages 53 to 89 are most likely to take a medication for one

of these conditions, this age groups is the least likely to recall a prescription drug advertisement

(Thompson, 1998).

Many patients have acted as a result of these prescription drug advertisements. 23% of ad

viewers talked to their doctor about a medication as a result of seeing an ad. (Kaiser HealthPoll,

2005). A study by Bell et al (1999) suggests that 35% of people who have seen DTC

advertisements asked their physician for more information, and 19% of ad viewers actually asked

for a prescription as a result of DTCA. According to Thompson (1998), 33% of those who saw

advertisements asked their doctor about the medication, 28% asked for a prescription, which was

honored by doctors in 80% of the cases. This amounted to 163 million people recalling the

advertisements and 54 million people asking their doctor about advertised products in 1998.

Since then, these numbers have risen sharply as advertising has become even more pervasive.

The outcomes of these advertising generated requests are summarized from the Kaiser

HealthPoll Report (2005):

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Actions Taken in Response to Patient DTCA Request Population who saw

ads and talked to Doctor (23% of Ad Viewing Population)

Ad Viewing Population (90% of Adults Surveyed)

Recommended lifestyle change

57% 13%

Prescription for Advertised Drug

52% 12%

Different prescription 44% 10% OTC drug 34% 8% No drug 26% 6% Recommend Any Rx drug 75% 18% Table 3.1 Actions taken in response to DTCA motivated requests. Taken from Kaiser HealthPoll Report, 2005.

The effects of these requests are significant. Between 1998 and 1999, total US drug

expenditures increased by nearly 19%: the number of prescriptions for the 25 most highly DTC

advertised drugs rose 34%, while prescriptions for all other drugs rose 5.1% (Woloshin et al,

2001). Similarly, a study by the US National Institute for Health Care Management Research and

Educational Foundation found prescriptions for the fifty most heavily advertised drugs grew at a

rate six times greater (24.6%) than other drugs (4.3%) between 1999 and 2000. In New Zealand,

the Ministry of Health conducted a study which suggests that 21.9% of the growth in

prescriptions between 2000 and 2002 can be attributed to DTCA advertising (Wilson, 2003).

Overall, DTC advertisements have changed the rate of prescription for advertised drugs.

Besides prescriptions, DTCA has also increased the demand for other forms of treatment.

14% of patients disclosed health concerns as a result of advertising. Six percent of patients

requested preventative care, while five percent requested a test, medication change, or specific

referral (Murray et al, 2004). Only one percent of patients reported a worse outcome as a result

of DTC advertising. These patients mentioned worse treatment, serious dissatisfaction, or

discomfort when the physician acted challenged. Nonetheless, patients rarely reported worse

physician encounters from DTC generated visits. The question remains, however, whether the

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increase in prescriptions and health care use as a result of DTCA has led to better health

outcomes.

DTC advertisements may have the largest impact on people of low socioeconomic status,

a group that is difficult encourage to visit their physician and to request treatment for many under

diagnosed conditions. A study by Murray (2004) found that 24% of all people scheduled a visit

with their physician specifically to talk about a prescription drug advertisement. Importantly,

these individuals were generally from populations that are hard to target – patients with low

education. (78% of patients did not graduate high school, and 58% had no high school education

whatsoever.) 13% of the all patients who discussed an advertisement with a physician either had

the condition or were at risk for it. Furthermore, doctors believed the advertised medication

which they prescribed would be helpful in 30% of cases they prescribed an advertised drug in

response to a patient’s request. This was most prevalent for patients with low incomes, low

education levels, and people who are not proactive about their health. Unfortunately physicians

also granted 12% of ad generated prescription drug requests in which they did not believe the

therapy would be helpful. Patients aged 18-24 were most likely to receive prescriptions in which

the physician did not have full confidence.

Overall, the data show that DTCA encourages approximately 20% of patients to visit

their doctors. There is great debate whether these increased visits are by underserved populations

leading to discussions about under-diagnosed conditions, or whether this increased traffic simply

taxes physician’s time as they explain why certain medications are not appropriate. The data

suggests that the visits are not a complete misuse of physicians’ time, since doctors respond by

issuing a prescription in 75% of these visits, actually prescribing the requested advertised drug in

approximately 57% of visits (Murray et al, 2004). Again, many question whether prescriptions

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for these new drugs led to better health outcomes, or whether these prescriptions are

unnecessary, and even inappropriate at times, leading to the large increase in health care costs.

3.2 DTC Advertising Mediums

Of the patients who recalled seeing a DTC advertisement, 94% remember television

promotions, 62% recall newspaper and journal advertisements, and 22% recall radio spots

(Kaiser HealthPoll, 2005). As seen from the breakdown of DTCA expenditures in the Table 3.2,

the recall from television advertising is much higher than the proportion of DTCA dedicated to

television (~60%). This could be caused by two factors: first, according to FDA regulations, all

television campaigns must run concurrently with a print campaign where consumers can get

more information. Though companies may wish to dedicate more of their DTCA budgets to

television advertising, the regulations require a high level of print advertising. Second, television

advertising is only effective if advertisements are shown repeatedly on several different

television programs. The high cost of television advertising may lead to the disproportionate use

of this media by prescription drugs with high DTCA budgets. Prescription drugs with lower

DTCA budgets may only use print media, which lowers ad costs and can be more easily targeted

to specific magazine readerships (and thus demographics).

From 1999 to 2004, 41% of DTCA was spent on television advertising each month and

50% on print advertising. However, companies generally spent 80% of its DTCA advertising

budget on one form of media or the other in a particular month. This supports our hypothesis that

only prescription drugs with high advertising budgets employ television advertising. Other

prescription drugs with smaller budgets, highly targeted patient populations, or more

complicated risk information mainly rely on print media. Rosenthal et al (2002) showed that the

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variance among DTCA advertising budgets is quite significant: “The ratio of DTC expenditures

to sales for the class with the highest expenditures was 23 times as high as the ratio for the class

with the lowest expenditures. By contrast, spending on promotion to professionals as a percent of

sales varied by a factor of three.” The disparity in advertising budgets causes a bifurcation. High

budget advertising campaigns focus on television advertising, which seems to be recalled at a

much higher rate, while lower-budget campaigns rely primarily on print media.

DTCA Expenditures By Medium Year TV Print Radio Other Total 1999 910,601.0

(56.98%) 675,615.2 (42.28%)

9,192.6 (0.58%)

2,571.3 (0.16%)

1,597,980.1 (100%)

2000 1,427,912.0 (63.23%)

795,290.8 (35.21%)

33,005.4 (1.46%)

2,234.1 (0.10%)

2,258,442.3 (100%)

2001 1593343.3 (64.26%)

861,352.6 (34.74%)

22,958.3 (0.93%)

1,957.1 (0.08%)

2,479,611.3 (100%)

2002 1,552,666.1 (61.80%)

929,329.3 (36.99%)

12,819.9 (0.51%)

17,389.3 (0.69%)

2,512,204.6 (100%)

2003 1833131.72 (59.36%)

1210811.93 (39.21%)

39507.95 (1.28%)

4450.34 (0.14%)

3087901.94 (100%)

2004 2539269.48 (66.15%)

1259109.11 (32.80%)

36058.78 (0.94%)

4024.74 (0.10%)

3838462.11 (100%)

Table 3.2. DTCA Expenditures by media type in thousands of US dollars and percentage of DTCA expenditures spent on a given type of media each year. TNS Media Intelligence, 1999-2004. 3.3 Characteristics of Drugs that Employ DTCA

Spending on DTC is highly concentrated on products which generally treat chronic

conditions and have a low incidence of side effects (Rosenthal et al, 2002). Patients are most

likely to benefit from information about drugs that they take repeatedly for chronic conditions,

while they rely on their physicians to recommend the best treatments for acute, short-term

problems. This information and perhaps repeated experience may cause patients to form a brand

preference, increasing the returns to advertising for firms. Companies often take the following

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criteria denoted by Roth (1996) into account when determining whether to use DTCA for a

particular drug: market size, drug usage, side effects, and state of the product life cycle.

Since DTCA is difficult to target to specific patient populations, DTCA campaigns

generally feature treatments that are “widely prescribed to diverse heterogeneous markets.”

Advertised drugs also treat conditions that have considerably less complex symptoms, and less

complex treatments, so advertisements appear for products that “should be the easiest for

[consumers] to understand and that run the lowest risk of providing new and complex

information that could lead to customer confusion” (Roth, 1996).

Generally DTCA increases the size of a particular drug market, but does not alter the

market share for a particular brand name medication. Therefore, market leaders receive the

greatest returns on advertising investments that stimulate the demand for a particular drug class.

Firms are also more likely to advertise products early in the product’s life cycle, while the

manufacturer can charge monopoly prices under patent protection, repeating the maximum return

on advertising investments. Products early in their life cycle are also more likely to have

differentiating characteristics, and thus a greater potential to capitalize on their brand

differentiation.

As theory suggest, advertisements are most likely to appear for market leaders that target

a broad customer base for chronic conditions which are easily understood and have a low

incidence of side effects.

3.4 Characteristics of Prescription Drug Advertisements

Increasingly, prescription medications are advertised in the same manner as cars and

cereal, through a “process that meets the psychological and social needs of the consumer”

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(David, 2001). This method is likely chosen because advertisements with transformational

appeals (i.e. positive or rewarding stimulation) have higher ad awareness, or advertisement

recall. According to Cline (2004), transformational messages such as images of health, happy,

socially engaged product users, offer rewards that are associated with the observed behavior, in

this case a prescription for the medication. Social cognitive theory suggests that these rewards

become the motivator for the observed behavior. According to her, DTCA likely provides

models with whom the consumers identify, and are presented as having personal features and

engaged in activities that the viewer desires. These rewards function as the motivation for

consumers to follow the “directions” in the advertisement to speak to their doctor about a

particular drug.

An analysis by Woloshin et al (2001) showed that 67% of DTC advertisements used

emotional appeals. The most common appeal was the desire to get back to normal, which was

seen in 60% of the advertisements using emotional appeals. According to Cline (2004), being ill

constitutes a threat to identity: “People with chronic illnesses risk permanent loss of features of

their identities…controlling one’s illness means controlling one’s identity.” Therefore, most

DTC advertisements reflect at least one identity reward. Ads also depict social rewards as well,

such as family (31.1%), romance (29.8%), and work (5.4%).

Two marketing research theories lie behind the methodologies of advertising: classical

conditioning and the expectancy-value theory. In advertising, classical conditioning refers to the

use of images, music, and verbal cues to elicit certain emotions, which become associated with

the promoted product. A common example is the use of sexually attractive models that form a

connection between the arousal created by the model and the product. DTC advertisements use

classical conditioning to associate drugs with a range of emotional experiences. For example,

21

DTC advertisements associate the joy of playing in beautiful fields for allergy sufferers’ with

Claratin, the love conveyed by an elderly patient with arthritis hugging a child to Celebrex, and

the happiness of a smiling, bouncing cartoon character for depressed patients with Zoloft. The

majority of advertisements depict exclusively healthy appearing people (92%) participating in

physical activities (43%) or social activities (17%). 72% of prescription drug advertisements

depict at least one person smiling (Cline, 2004). Through classical conditioning, the positive

images, along with verbal messages that reinforce the efficacy of the advertised medication,

associate the drug with the relief from pain, anxiety, and uncertainty associated with these

conditions.

Similarly, the expectancy value theory in advertising suggests that commercials can teach

viewers what to expect by demonstrating the rewards of following advice or the punishments for

failing to do so. Based on this theory, many pharmaceutical advertisements first highlight the

pain and suffering of medical conditions as a context for presenting benefits of relief associated

with medication use (Cline, 2004). This ‘teaches’ the viewer to expect relief. Of the strategies

used to increase expectancy of a drug, a cycle of anxiety is commonly employed. 42% of

magazine drug advertisements appeal to fear, or focus on the cycle of anxiety, as a marketing

strategy (Pinto, 2000). Commercials for conditions such as high cholesterol, acid reflux disease,

and osteoporosis first assert that minor symptoms or unassessed biological parameters can have

grave implications, often while emphasizing the prevalence of these conditions (Morris, 1997).

The commercials then introduce the promoted drug as the solution, alleviating the anxiety

created by the commercial, which not only amplifies the consumer’s perception of the drug’s

value, but also increases the perceived value of the identity and relational rewards offered in the

advertisement.

22

Figure 3.1. Image from the “Falling Starlet” advertisement for Lipitor that appeared in 2002.

Conditioning through this cycle of anxiety is aptly displayed in the “Falling Starlet”

atorvastatin calcium commercial that aired and appeared in print during 2002 (Figure 3.1). As an

attractive woman gracefully glides down a paparazzi-lined red carpet, boxes appear on the screen

detailing her height (5 foot, nine inches), weight (125 pounds), and dress size (size 6). When her

cholesterol level appears on the screen (273 mg/dL, [7.1 mmol/L]) she suddenly trips, as if from

a heart attack, suggesting that a seemingly healthy woman can be suffering from high cholesterol

that may lead to major health problems. Next, the already anxious audience is warned, “High

cholesterol does not care who you are.” The commercial informs the audience that one fifth of

Americans have high cholesterol, suggesting the need for all viewers to be concerned about

hyperlipidemia’s serious implications. After creating this anxiety, the advertisement numerically

23

displays Lipitor’s effectiveness and depicts the women being helped to her feet by an attractive

man, who stays by her side as she continues down the carpet to receive an award. The

advertisement offers numerous identity awards through the glamour and appearance of the

beautiful women. The large adoring crowd and handsome gentleman also offer relational

rewards. The relief at the end of the commercial completes the cycle of anxiety and produces the

expectancy of benefit.

The message in this and other advertisements is obvious: Patients with a given condition

can be attractive, healthy, and successful if they use the prescription drug that is advertised.

These associations may be credible for conditions such as allergies or irritable bowl syndrome,

but may not be appropriate for people certain forms of cancer or severe arthritis. In fact,

psychiatrists thought that “certain adverts were potentially offensive to both patients and care

[takers]. Unrealistic and stereotyped images were considered inappropriate and demoralizing to

those directly and indirectly affected by Alzheimer’s Disease” (Sauer et al, 2002). Advertising

slogans have actually been altered because they promote ideals that were so unrealistic. The

marketing slogan used by Aricept, “Mum has Alzheimer’s disease but she knew I was calling

today,” was changed to “Real lives –realistic expectations.” The unachievable results portrayed

in the first slogan can not only be demoralizing to families with someone who suffers from

Alzheimer’s disease, but may make DTCA very harmful. Unrealistic expectations may cause

patients to demand drugs that are inappropriate, strain the physician patient relationship, and

increase health care costs through higher prescription rates and the extra time physicians must

use to explain why the drugs are not as effective as the advertisements suggest.

Emotional appeals using identity and relational rewards may be very effective in

generating advertisement awareness and motivating patients to see their physicians. As Wolfe

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suggests, “customers often choose a product on the basis of emotional appeals” (Wolfe, 2002).

When one is choosing a dishwashing detergent or soda, unrealistic exceptions formed by these

appeals may lead to temporary disappointment, but no real long term health effects or

inefficiency in the market. Since pharmaceuticals have a much greater impact on health and face

the principle agent problem, the consequence of unrealistic expectations is much higher. They

may lead to inappropriate prescriptions, frustration with doctors, and unnecessary waste in the

health care system.

Emotional appeals in DTCA clearly have an important role in promoting the awareness.

Regulation of these appeals, though very difficult to create, is vital to ensuring the social benefits

of DTCA and minimizing its harm. Realistic expectations can partially be created through

incorporating concrete evidence about the drug to help consumers determine whether a drug is

potentially appropriate for them. Unfortunately, prescription drug advertisements provide little

concrete information to affirm the emotional experiences depicted in the advertisements. Few

advertisements indicate the symptoms of the disease, the success rate of the drug, alternative

treatments that could improve health, or make the side-effects of the drug easily understandable

to the consumer.

According to Roth (2003), only 42.7% of advertisements conveyed information about the

disease. 40% of advertisements fail to describe any symptom for the condition being treated by

the advertised drug or fail to explicitly state that the condition could be a “silent disease” (Bell et

al, 2000). Half of these advertisements were either targeted to people who already have been

diagnosed with the condition and therefore are aware of its symptoms, while the other half were

for conditions with well known symptoms, such as pregnancy, impotence and tobacco addiction.

Nonetheless, it is surprising that so few advertisements discuss symptoms or the course of the

25

disease. Only 27% of advertisements discussed the precursors to the condition (such as causes or

risk factors) and only 12% of advertisements discussed the prevalence of the disease (Bell et al,

2000). This suggests overall prescription drug advertisements contain little disease related

educational content.

Information on the benefits of a drug is sparse within advertisements as well. Benefits

derived from the drug are mostly described in qualitative terms, such as “clinically proven,

proven relief, or proven effective.” Of the ads that discussed the benefits of the drug explicitly,

only 13% provided any evidence to support their claims. Rather, advertisements relied on

personal testimonials (12%) or appealed to the widespread use of the drug (i.e. “more than

1,000,000 have used Rezulin to help manage their diabetes”), (Woloshin et al, 2001). The lack of

quantitative evidence may allow the impressions created by the emotional appeals to replace

information on the actual effectiveness of the medication. According to Woloshin et al (2004),

“the absence of benefit data may lead some patients to assume that the drug always works.”

To determine whether the lack of benefit information makes patients have a higher

expectation of the drugs, Woloshin et al (2004) created drug advertisements that incorporated a

standardized “benefit box” which listed the effectiveness of the advertised drug, a competitor,

and placebo. Most patients rated drugs as “extremely effective” or “very effective” when they

were shown the standard advertisement. After being shown the advertisement with the benefit

box, the proportion of people who rated the drugs very highly fell from 51% to 26% for Lipitor,

and from 65% to 28% for Celebrex. The benefits box also caused more respondents to recognize

that Celebrex has approximately the same efficacy as ibuprofen. The authors of the study

conclude that “perceptions of drug effectiveness were much lower for ads that incorporated the

benefit box than for ads that did not.” This suggests that the emotional appeals used within the

26

advertisement take the place of comparative data on efficacy within the minds of consumers. The

heightened expectations formed from these emotional appeals may decrease the benefits of

DTCA by causing waste of physician time, inappropriate prescriptions, and increased costs.

Most of the advertisements (98%) explicitly stated the necessary risk information because

this information is mandated by the FDA, and “51% went beyond the FDA requirements and

named side-effects and provided quantitative data about their frequency” (Woloshin, 2001).

Nonetheless, pharmacists still believed that one-third of the advertisements failed to achieve a

“fair balance” in the presentation of the risks and benefits. Pharmacists cited an absence (15% of

ads) or shortage (10% of ads) of risk and/or side effect information as the main reasons

advertisements failed to achieve balance (Roth, 1996).

Though there appears to be minimal educational content contained in the advertisements,

pharmacists found the accuracy of the information available to be very high (Roth, 1996).

Furthermore, information contained within the advertisements is not relegated to the text. Cline

(2004) suggests that information such as the patient population can be taken from the images

used within the advertisement. Over half the advertisements depicted adults only (58%),

although advertisements for cardiovascular (58%) disease and diabetes (50%) showed a mixture

of age groups, generally older adults with children. 88% of the advertisements depicted only one

ethnic group, with approximately 75% of ads depicting whites, 14% depicting African

Americans, 2% depicting Hispanics, and only 0.5% depicting Asians.

According to Cline (2004), DTCA also tends to reinforce social stereotypes. Females

dominated advertisements for psychiatric products, while men dominated advertisements (66%)

for cardiovascular disease, despite the fact that cardiovascular disease is the number one killer of

both men and women. Similar trends can be seen in the depiction of different ethnicities.

27

According to Cline (2004), “The principle of homophily suggest that consumers are more

likely to attend to and be persuaded by sources perceived as similar to themselves.” The under-

representation of certain patient populations may prevent theses groups from gaining the full

educational value from DTCA. Cline suggests, “these visual cues reinforce already existing

disparities in access to health information and, to the extent that advertisements promote visits to

physicians, disparities in access to health care.”

Since many proponents of DTCA suggest that advertisements give patients the

confidence and motivation to talk about certain conditions that have been socially taboo, it is

disappointing that the patient populations depicted do not defy sterotypes in order to target

patients at risk. Instead, patient populations tend to correlate with marketing ideals. Many

advertisements for erectile dysfunction depict fit, healthy men in their forties. Though erectile

dysfunction drugs are approved by the FDA for men over age 18, the average patient is

significantly older. Many question whether the advertisements cause middle-aged to

inappropriately demand Viagra, or whether these advertisements have removed the social stigma

for middle-aged men to discuss erectile dysfunction drugs with their doctors. Though the case of

erectile dysfunction is troublesome, DTC advertisements should strive to break down social

stereotypes when other patient populations are clearly at risk.

DTC advertisements employ effective emotional marketing strategies, such as classical

conditioning and the expectancy-value theory to associate drugs with identity and relational

rewards, while teaching the viewer what to expect from the treatment. The visual content of the

advertisements may also teach the viewers about the expected patient population. Unfortunately,

the advertisements do not contain a lot of quantitative evidence about the benefits of the therapy.

This omission may allow consumers to perceive the drugs as more effective because they replace

28

the efficacy measured in randomized trials with the efficacy depicted in the emotional appeal.

These heightened expectations may cause an increased in demand for inappropriate

prescriptions, strain the physician-patient relationship, and lead to waste in the health care

system.

3.5 Factors that Influence Consumer’s Awareness of Prescription Drug Ads

The dearth of quantitative information in DTC advertisements may not only increase

perceived efficacy, but also increase ad awareness. According to Roth (2003),

“[advertising awareness] was greater when disease symptoms were not conveyed…advertisements that convey symptom information, which is typically negative, risk not being recalled by consumers…[because] people can be overly optimistic in assessing their susceptibility to health risks and therefore alienated by advertisements that present threat or severity information.”

Similarly, ad awareness was higher for drug advertisements that did not make any direct

comparisons between treatments (32.35% of patients aware of drug ad) than advertisements that

compared treatments directly (22.59% awareness) or only made indirect comparisons (29.59%

awareness). Above all, messages that relied on transformational appeals, such as sensory

gratification, intellectual stimulation, or social approval, had higher advertisement awareness

than strictly informational appeals (Roth, 2003).

Overall, awareness of prescription drug advertisements is correlated with people who had

a high exposure to magazines, frequent television viewership, used prescription drugs, evaluated

their health less positively, and believed their health plan would cover the cost of the drugs (Bell

et al, 1999). Interestingly, individuals tend to be fairly selective in attending to advertisements.

People were considerably more likely to recall advertisements that address their medical

condition. According to Bell (1999), “attention to DTC advertisements is driven by the basic

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principle of subjective utility; that is, we process information that is perceived to have personal

value.” This may partially explain why advertisements with disease and symptom information

may be less memorable. Presumably people who have been diagnosed with the condition

perceive the symptom and disease information to be less useful because it does not offer new

information, and therefore these patients may not give the advertisement much attention (Roth,

2003).

This raises difficult questions about the aim of prescription drug advertising. If the

ultimate goal of DTCA, as Pfizer suggests, is to motivate consumers to act by consulting their

doctors and engaging in better dialogue with them about their individual health situations, then

the transformational appeals employed may be appropriate. However, these appeals must be

constructed very carefully so that people do not incorrectly believe they are fully informed about

the drug, causing them to make inappropriate demands of their physician. As Pfizer states,

“consumers cannot be expected (or induced) to believe that they are sufficiently informed to

make judgments about relative benefit and risk without assistance of their physicians” (Federal

Register Comment, 2003). However, this should apply not only to the informational content of

the advertisement, but also the perception created through various emotional appeals.

Informational content may reduce ad awareness for prescription drugs, but it may improve the

overall social benefit of advertising by allowing people to select the advertisements that are truly

relevant to their health needs, rather than advertisements that satisfy their transformational

desires.

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3.6 Viewers’ Recall of Prescription Drug Advertisements

DTCA increases consumers’ awareness about prescription drugs; however, the rate at

which prescription drug advertisements are recalled vary quite a bit. In a study by the Kaiser

Family Foundation, which placed special TV boxes in households that aired prescription drug

commercials in place of other ads, commercials for Lipitor were recalled by 82% of viewers,

while only 54% of viewers recalled the Singulair ads and only 48% recalled the Nexium ads.

Viewers learned about the indications, side effects, and alternative therapies of drugs from the

advertisements. However, consumers also aggregated incorrect knowledge. “Up to 6% of

[viewers] drew incorrect conclusions about the product that were not explicitly stated in the ad

and up to 14% indicated mistaken impressions as the main point of the ad” (Zachry, 2003). The

Kaiser study (2005) showed that people replaced their uncertainty with incorrect information.

Awareness of Content in DTC Advertisements No

DTCA DTCA Viewer

Change

Awareness of Disease Progression (Acid Reflux)

68%

79%

+11

Awareness of Indication (Lipitor) (Nexium) (Singulair)

34% 8% 14%

88% 84% 87%

+54 +76 +73

Awareness of Usage (Singulair – Don’t take during asthma attack) (Singulair – Incorrect usage information)

12% 13%

19% 25%

+5 +12

Awareness of Alternative Therapies (Exercise for high cholesterol)

57%

70%

+13

Table 3.3. Awareness of information contained in DTC advertisements. Taken from “Understanding the Effects of DTC Prescription Drug Advertising,” Kaiser Family Foundation, 2001.

The advertisements significantly increase the population’s awareness of the condition that

the advertised drug is used to treat. They also help to educate people about disease progression,

lifestyle changes, and how drugs should be used. Unfortunately, the advertisements also increase

the misconceptions about drugs. For instance, twice as many people “learned” the incorrect use

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of Singulair from drug advertisements as the number of people who learned the correct usage.

This trend translates to the risks and side effects of the medication as well, although it is not as

pronounced. When asked about particular side effects, there was a 45% increase in the number of

people who correctly identified the side effects for a given drugs; however, there was a 15%

increase for all the incorrect side effects as well. Similarly, the advertisements increased the

number of people who correctly identified the contraindications by 50-60%, yet 30-40%

identified numerous additional incorrect contraindications. This suggests that the advertisements

make consumers feel empowered with knowledge about advertised prescription drugs. Many

consumers gained valuable information, yet a smaller, but still significant proportion acquired

incorrect information, which may lead them to demand inappropriate drugs or shy away from

treatments that they incorrectly view as dangerous. According to Roth (1996), this incorrect

information is propagated through DTCA by misunderstanding or indirectly by reinforcing prior

erroneous knowledge.

The advertisements can also serve as a useful reference to make people feel more

empowered. 29% of people believe they gain “a lot” or “somewhat more” about the disease after

seeing a prescription drug ad (Kaiser Family Foundation, 2001). Many people seem to use the

print advertisements as a source of information. 56% of people who saw a prescription drug ad

claim to have read it “from beginning to end, ” with 17% of people clipping the ad for future

reference, and 9% calling the toll free number indicated in the ad for more information (Bell et

al, 1999).

The advertisements are an effective source of information for patients, especially

increasing the number of people who believe they are informed about the medication. Even if

incorrect information is obtained, the increased motivation to speak to a physician as a result of

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learning may be beneficial. However, regulations should be carefully written so that expectations

created by incorrect information do not strain the physician-patient relationship or cause

inappropriate prescribing practices. DTC advertisements should be written in a very accessible

language and format to reduce the misunderstandings from these advertisements. Firms may

already be achieving this goal. According to Bell et all (1999), “education was not strongly

related to awareness (or to any outcome measure), suggesting that DTC advertisements, like

promotions for most consumer products, are designed to be accessible to mass audiences.” The

advertisements should also strive to correct any misconceptions about a disease that are widely

held by the public, because DTC advertisements may otherwise inadvertently spread this

incorrect information.

3.7 Consumers’ Opinion of DTCA

Consumers’ opinions of DTC advertisements vary quite a bit, although people are

generally neutral towards DTCA. In a survey, only 19% of people thought that the

advertisements were “bad” or “very bad;” 47% thought the ads were “good” or “very good,” and

34% were neutral (Murray et al, 2004). 64% of people who have seen the advertisements believe

that they provide useful information “at least some of the time” (Kaiser HealthPoll, 2005).

However, only 18% of ad viewers trust the information that is provided in these advertisements

“most of the time.” Trust in these advertisements has declined since they were introduced in

1997, when over a third of viewers believed the information was trustworthy (Kaiser HealthPoll,

1999). Nearly 60% of patients believe that “advertisements for prescription drugs make the drugs

seem better than they really are” (Berndt, 2005).

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Consumers turn to prescription drug advertisements for many different reasons. The

advertisements are generally successful at fulfilling what consumers believe are the primary

purpose of their advertisements. 29% believe the primary purpose of the advertisements is to

increase awareness about illnesses and the medications that can be used to treat them. In fact,

opinion surveys show 72% believe advertisements improve people’s understanding of medical

conditions and treatments (Murray et al, 2004). Another 18% of people believe that the primary

purpose of drug advertisements is to determine whether a medicine is “right for me or someone

in my family” (Federal Register Comment, Eli Lilly, 2004). Drug companies are fairly successful

at making patients aware of treatments and helping patients become involved in the prescription

decision. 69% of patients agree that the advertisements help them get treatments they would not

otherwise receive (Murray et al, 2004). The majority of consumers believe that the main purpose

of the prescription drug advertisements is to “encourage me to talk to my doctor” (Federal

Register Comment, Eli Lilly, 2004). As discussed in section 3.1, approximately one-fifth of ad

viewers talk to their doctor about a condition or drug that they saw advertised. Moreover, 88% of

patients believe that the advertisements give them the confidence to talk to their physicians about

their concerns (Murray et al, 2004). In consumers’ opinions, drug advertisements successfully

increase awareness about different conditions and the treatments available, help patients

determine whether these treatments are appropriate for themselves or someone in their family,

and make them more confident in discussions with their physician.

Drug advertisements are less successful at informing patients of the benefits and side

effects associated with their medication, which 16% of people believe is the primary purpose of

the advertisements (Federal Register Comment, Eli Lilly, 2004). Nearly 60% of patients agree

that “advertisements for prescription drugs do not give enough information about the possible

34

risks and negative effects of using the drug” (Berndt, 2005). Consumers would like more

information about both benefits and side effects. 92% of patients said they would require data on

both benefits and side effects in drug advertisements, with 76.2% of patients indicating that they

would like to be informed of all possible side effects (Woloshin et al, 2004). Unfortunately, there

seems to be a divergence between what consumers want to know and what they can practically

assimilate.

A study by Eli Lilly (2004) showed that patients were able to recall information about

side effects more accurately if only four side effects were mentioned in the ad, rather than eight

or twelve. The four most common side effects were recalled at decreasing rates as the number of

side effects included were increased, suggesting that the inclusion of additional side effects

effectively diluted “the respondent’s ability to recall, arguably, the most important items in the

list of side effects” (Federal Register Comment, Eli Lilly, 2004). Overall, patients generally

recalled only one side effect. This data suggests that the “less is more” approach to the

communication of risk information may increase retention and comprehension.

In consumers’ opinions, drug advertisements do not provide information about benefits

and risks associated with a medicine in a useful manner. (Although studies question whether

patients would be able to assimilate this information even if it was provided in a clear fashion.)

Consumers believe, however, that the advertisements empower them to speak to their physician

and help decide which medications are appropriate for themselves and their family members.

3.8 Misconceptions Surrounding the Regulation of DTCA

There are many misconceptions surrounding DTCA. Although consumers have become

more skeptical of these advertisements, it is still important that consumers do not develop

35

misplaced expectations for advertised drugs based on an unwarranted sense of safety from

government regulations. Many consumers believe that only the safest drugs can be promoted

directly to consumers. Furthermore, 50% of ad viewers believed that the advertisements had to

be submitted to the government for approval before the advertisements are released (Bell et al,

1999).

Misconceptions Surrounding DTCA Thought ads had to be submitted to government for approval 50% Thought that only “completely safe” drugs could be advertised 43% Thought only “extremely effective” drugs could be advertised 21% Thought ads for drugs with major side effects were banned 22% Table 3.4. Common consumer misconceptions surrounding the regulation of DTCA. Taken from Bell et al, 1999.

The FDA requests that drug companies submit all their direct-to-consumer promotional

materials to the Division of Drug Marketing and Communication. However, many of the

materials are reviewed once the ad campaigns have already begun. Often times, the ad campaign

will have fully aired before the FDA takes any disciplinary action on advertisements that violate

regulations. Once violations occur, the FDA usually requests that the advertisements be

terminated immediately. The FDA may also request that pharmaceutical companies send letters

to physicians clarifying anything that violated the regulations. If the violations are egregious, the

FDA may also request that the pharmaceutical company air remedial advertisements correct the

information in the original advertisement. Since 1997, the number of DTC advertisements in

violation has decreased; though many attribute this to a growing number of advertisements with

few FDA resources to police the advertisements, not the improvement of DTCA compliance with

regulations.

Clearly FDA regulations surrounding DTC advertising do not provide the safety-net that

many consumers believe exits. Once the regulations were explained to consumers, 51% believed

that there should be more regulation, while 39% of consumers believed there is “just the right

36

amount of regulation” (Kaiser HealthPoll, 2005). Regardless of whether the regulations are

changed, consumers may benefit from knowing that any drug, regardless of its safety profile, can

be advertised.

False assumptions about the regulations can lead to an increase in the negative effects of

DTCA. Bell found that “individuals who held erroneous beliefs tended to be more aware of such

advertisements and were somewhat more likely to act on them” (Bell et al, 1999). Given the

highly contentious nature of DTCA, educating the public about the informational content and

monitoring of these advertisements may help to limit the negative impacts of DTCA.

3.9 Doctors Response to Patient Expectation

Studies thus far suggest that consumers are most aware of drug advertisements that

employ transformational messages, and contain little quantitative evidence about the benefits of

the drug. As Roth (2003) states,

“relating product benefits to positive motivations, primarily happiness and to a lesser extent social approval, appears to be effective in creating memorable messages, yet it is not often possible to associate product risks with transformational (desirable) motives – or do so in a manner that creates a fairly balanced advertisement. The results make a compelling inferential cast that benefit as opposed to risk information tends to be more highly associated with brand-level advertising awareness.”

This may explain why pharmacists believe over one-third of advertisements do not achieve “fair

balance” between risks and benefits, even through 98% of advertisements incorporate the

necessary risk information. Add to this that over half the population unjustifiably believes the

government provides protection from harmful DTC advertisements, and physicians are

confronted by patients who have vastly heightened expectations about advertised medications.

The law assumes that the physician is the agent who determines whether a prescription is

37

appropriate solely based on the scientific evidence and mediates the expectations the patient may

have, thereby protecting patients and the public from inappropriate prescriptions and unnecessary

rising prescription drug costs.

Unfortunately, studies indicate that physicians do not fully assume the role that the law

suggests. In general, physicians accede to patient requests because “[m]eeting patients’

expectations produces greater satisfaction with care, which in turn is related to greater adherence

to medical advice, less “doctor shopping” and a lower propensity to sue for malpractice”

(Kravitz, 2001). Physicians accede to both DTCA (78%) and non-DTCA generated requests

(72%) at a high rate (Mintzes et al, 2003). This is largely a factor of expectation. Bereger et al

(2001) determined that the issuance of a prescription is highly correlated with patient expectation

and physician perception of patient expectation. Mintzes et al (2003) showed that physicians

believed patients who requested a drug were knowledgeable about the therapy. This perception

of knowledge may be translated to the perception of patient expectation for a prescription,

potentially leading to inappropriate prescribing: evidence shows that many patients who request

drugs based solely on DTC advertisements have not been informed about the true efficacy of the

drug, and may have misunderstood the side effects of the medication. Therefore, physicians may

be mistaken in their perception that the patient is well informed, leading to questionable

prescriptions as both the patient and physician believe that the other is more informed. In fact,

“physicians were more likely to express ambivalence about drugs patients had requested,

particularly advertised drugs” (Mintzes et al, 2003). Meanwhile, physicians cite patient demand

as the number one reason for inappropriate prescribing (Rosenthal et al, 2002).

An innovative study by Kravitz et al. (2005) was devised to determine whether DTCA

requests led to an increase in appropriate prescriptions or for treatments that are only marginally

38

beneficial. They hired standardized patients, or actors, to visit physicians across the country

complaining about symptoms of depression or adjustment disorder. The actors would present

their symptoms and ask the doctor one of the following:

a) whether Paxil, an antidepressant they had seen advertised on TV was appropriate

b) for a treatment for depression after claiming to have learned about the disease

from an educational television program

c) make no request.

Physicians recorded depression as a possible diagnosis in 80% of the patients presenting with

depression and in 39% of the actors who displayed adjustment disorder with depressed mood.

The diagnosis of depression was much greater in patients who made a request for medication

(88%) than actors who made no request (65%). Similarly, actors presenting with adjustment

disorder were diagnosed with the condition in 50% of the cases when a drug request was made,

but in only 18% of the cases with no requests. The minimally acceptable care for those

diagnosed with major depression consists of a combination of a prescription for an

antidepressant, mental health referral, and follow-up within two weeks. The actors in this study

portraying adjustment disorder presented with mild symptoms, making “the prescription of an

antidepressant…at the margin of clinical appropriateness” (Kravitz et al, 2005).

The study clearly shows that general or brand specific drug requests increased the

probability that a patient receives the minimally acceptable care:

Table 3.5. Minimally Acceptable Care According to Patient Requests Actors with Major Depression Percentage Receiving Minimally

Acceptable Care Made Brand Name Request Based on DTCA 90% Made General Request Based on TV Program 98% No Request 56% Table 3.5. Number of patients receiving minimally acceptable care according to different patient requests. Taken from Kravitz, et al, 2005.

39

Unfortunately, brand name requests and general requests also seem to increase the number of

prescriptions for adjustment disorder:

Table 3.6. Prescription Rates According to Patient Requests

Depression Adjustment Disorder Any Rx. Paxil Any Rx. Paxil Brand 53% 27% 55% 37% General 76% 2% 39% 10% No Request 31% 4% 10% 0% Table 3.6. The percentage of patients receiving minimally acceptable care according to their requests. Taken from Kravitz et al, 2005. Prescription rates for antidepressants were much higher when actors presenting with either

depression or adjustment disorder made a general request. Paxil in particular was prescribed at

significantly higher rates when a brand request was made. Paxil was given to 32% of patients

who requested it. According to Kravitz et al (2005), “more neutrally couched requests, generated

from noncommercial sources, might not produce so furious a rush to comply in clinically

equivocal situations,” explaining why patients who made brand specific requests received a

prescription for Paxil at higher rates than patients who only made a general request.

Kravitz et al’s study (2005) shows that DTC advertising leads to an increase in

prescriptions for both patients with conditions that are undertreated, and conditions for which

drugs are at the margin of therapeutic benefit. According to them, “the benefits of advertising

will tend to dominate when the target condition is serious and the treatment is very safe,

effective, and inexpensive. Harms are most likely to emerge when the target condition is trivial

and the treatment is relatively perilous, ineffective, or costly.”

Physicians respond to the expectations people form from DTC advertising. When the

expectations formed are in-line with optimal medical care, DTC may serve as a useful tool in

combating the under-treatment of disease. However, when patient expectations do not match best

care guidelines, DTCA has the potential to lead to inappropriate prescribing and waste in the

40

health care system. This study by Kravitz et al (2005) and other studies clearly show that

“patients can sway physicians to prescribe drugs that they would otherwise not consider.” This

suggests that physicians may not solely determine the appropriateness of prescriptions based on

their medical knowledge as the law expects, and that patient expectations significantly alter this

judgment. Therefore, regulators cannot rely on physician judgment alone to prevent patients

from receiving inappropriate or unnecessary prescriptions. Instead, regulations should be written

that strive to place the expectations created from the emotional and informational appeals within

advertisements in-line with the currently accepted best care practices.

Besides increasing the number of prescriptions for advertised drug classes, DTC also

impacts other elements of health care, such as the physician-patient relationship, patient

satisfaction with their health care, patients’ adherence to physician recommendations,

medicalizing, and the cost of health care.

3.10 Physician-Patient Relationship and Patient Satisfaction

Though physicians have objections to DTC advertising, they also acknowledge its

benefits and believe they can handle the burden of inappropriate patient expectations. 41% of

physicians believe DTC advertising has beneficial effects on their interaction with patients, while

59% disagree. However, when asked about the last encounter in which a patient discussed a DTC

advertisement, 83% stated that the ad had no adverse effect on their interaction (Federal Register

Comment, Bureau of Consumer Protection et al, 2003). In fact, 53% of doctors thought they had

a better discussion with their patients as a result of DTCA (Mitka, 2003).

Physicians did complain however, about the extra time needed to correct misconceptions

generated by DTC advertisements. According to physicians, 26% of patients requested drugs

inappropriate for their medical condition or for conditions they did not have. 9% of patients

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wanted a prescription rather than another more appropriate form of treatment. This leads 41% of

physicians to spend extra time correcting misconceptions (Mitka, 2003). Patients are aware of

the increased demand on physicians time: a survey by Murray et al (2003) found that 48% of

patients believe DTCA promotes unnecessary visits to doctors offices and 38% believe the ads

cause patients to “take up more of the doctors time.” It is difficult to determine whether this

increase in time is beneficial for the patient to convey new concerns to their physician, or

whether physicians are merely correcting the false expectations created by the emotional appeals

in the advertisements. Most likely, the increased time is beneficial for advertisements that

discuss widely under-diagnosed conditions, and harmful for conditions that are at the margin of

clinical benefit, as Kravitz et al suggest.

Though the advertisements place an extra burden on physicians to break down

inappropriate patient expectations, 53% of doctors claim they are not pressured to prescribe

(Mitka, 2003). However, 30% of patients feel the advertisements interfere with the physician-

patient relationship (Murray et al, 2004). This may reflect the fact that clinicians are more likely

to become frustrated with at DTCA generated request than requests from a “drug reference

book.” According to Zachry et al (2003),

“clinicians who received the DTCA patient scenarios were more likely to become annoyed with a patient who asked for more information about medications; less likely to answer the patients questions or provide additional written information; more likely to become frustrated or annoyed with the patient trying to ask a specific medication and less likely to provide samples or a prescription for the given medication.”

Patients may change physicians or health plans when a physician acts challenged or

denies a prescription for a DTCA drug. Patients who requested a medication but did not receive a

prescription were more likely to report a strained physician-patient relationship (Murray et al,

2004). In fact, 24% of patients were very likely to visit other physicians to get the prescription

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they denied by their original physician (Bell et al, 1999). Overall, dissatisfaction with health

plans is twice as high among patients who were denied a prescription by their physicians (15%

vs. 7%) 18% of patients who asked for a prescription and did not receive it claimed they would

change health plans, while only 9% of patients who received requested prescriptions claimed

they would switch health plans (Thompson, 1998).

Though 92.5% of physicians claim they will not prescribe a medication in order to avoid

repeated requests, it is difficult to believe the physicians do not change their behavior in order to

appease patients (Zachry et al, 2003). As Kravitz et al’s study (2005) shows, physicians change

their prescribing behavior in order to meet patient’s expectations. This can have negative effects

when the prescription is inappropriate. When physicians do not accede to requests, patients often

feel that the physician-patient relationship is strained, and may actually change physicians or

health care plans.

There can be many beneficial effects to heightened expectations, such as an increased

efficacy of medication through the placebo effect or increased compliance. However, these

expectations by patients must be created to closely align with best care practices in order to avoid

the negative impacts associated with the denial of a request for a prescription.

3.11 Increased Efficacy of Medication through DTCA Mediated Placebo Effects

According to Almasi et al (2006), the psychological expectancies and health effects

created by the increasing volume of direct-to-consumer (DTC) advertisements may facilitate and

strengthen the placebo effect associated with receiving medical care. The pill, doctor, and device

are stimuli that trigger a placebo effect: “the nonspecific psychological or psychophysiological

therapeutic effect produced by a therapy that is used for its nonspecific therapeutic effect … but

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is without specific activity for the condition being treated” (Shapiro, 1997). Identical

mechanisms apply to non-specific effects that augment therapies with known specific activity.

The magnitude of the effect produced can be highly influenced by information or suggestion

(Thomas, 1987; Lene et al, 2003; and Pollo et al, 2001). For example, 50% of the beneficial

outcomes associated antidepressant medications may result from the expectancy of relief, while

the active ingredients account for only 27% (Kirsch et al, 1999). Similarly, one third of patients

report relief from postoperative pain, cough, headache, and other conditions when given a

placebo (Beecher, 1955).

The emotional appeals in advertising not only function to create consumer demand for

the advertised products, but also create the expectancies that are key to enhancing a placebo

effect that occurs when the medication is taken. Through both emotionally conditioned responses

and observational learning of expectancies, patients learn about the rewards that will follow

when they take the advertised medicine. This initial expectation of benefit from the advertised

medicine is the foundation of the placebo effect.

The advertisements further seek to tailor the placebo effect with additional cues

associating a particular form of relief with a visually distinct product. For example, large tablets

engender a greater placebo effect then average-sized tablets, while extraordinarily small tablets

also have an enhanced effect (Morris, 1997). Advertising for Nexium modifies the cultural

placebo through color. The field of lilacs at the end of the commercial matches the color of the

capsule, reminding the viewer about the healing power of the “purple pill.” The emphasis on the

color of the pill throughout the commercial, and the name of its consumer website

(www.thepurplepill.com) create a conditioned stimuli that works to enhance the placebo effect of

taking the medication.

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Through previous encounters with medical care, patients are already conditioned to

associate medications with relief. DTC advertisements reinforce and amplify this association,

and tailor it to the specific products they describe. In this way, DTC advertising facilitates a

placebo effect of larger magnitude than would otherwise be expected from a prescription

medication.

A second implication is that patients’ positive expectations from DTC advertisements

may potentially reduce the amount of treatment requested or required (Walach et al, 1999). An

enhanced placebo response could also improve patient adherence and outcomes (CDER, 2002).

To the extent that advertisements “reward” patients for the same actions that physicians

recommend, patients may be more likely to follow treatment instructions and may enhance the

physician-patient relationship (Murray et al, 2003). Physicians may facilitate a placebo response

to the medications they prescribe by successfully borrowing strategies from DTC advertising. In

fact, improved communication might result from personalizing the need for treatment, placing

treatment benefits in perspective relative to drug side effects, and providing testimonial examples

of past treatment successes.

Optimal use of DTC advertising may require stricter guidelines on DTC advertisements

or more aggressive enforcement of current guidelines so that patients do not form unreasonable

expectations. Diminishing the demand for inappropriate prescriptions would lessen the negative

impacts of DTC advertising. Meanwhile, exposure to DTC advertisements might, nonetheless,

continue to improve health practices and outcomes through its ability to induce a placebo effect.

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3.12 Compliance.

The failure of patients to comply with their physicians recommendations is a critical

problem in health care. According to Woshinka (2005),

“Poor compliance occurs no matter how severe the potential consequences – even among patients with kidney transplants and frequent seizures. It is attributed to causes 125,000 premature deaths each year in the United States and increase rates of hospitalization….The annual cost of non-compliance to the United States economy has been estimated at a staggering $100 billion in added health care expenses and lost productivity.”

Many patients and physicians believe that DTCA has helped to combat this problem.

22% of patients said the advertisements made it more likely that they would take their

prescription medications regularly (Holmer, 2002). A study by the FDA showed that 33% of

physicians believe advertisements increase adherence (CDER, 2002). In fact, the probability that

a patient who received a prescription would remain with the regimen for more than six months

was much greater if the patient asked for the drug after seeing a direct-to-consumer

advertisement, according to Pfizer (Holmer, 2002). This claim has also been supported by work

from Donohue.

Woshinka (2005) used prescription data to examine compliance by measuring the number

of days between renewing a prescription. She states:

“Patients who started on paid therapy during months of higher advertising activity…are, on average, more compliant. Notably, only category advertisements matters, which gives further evidence of informational spillovers in DTC advertising. This translates to a very low missed days eleacticity of -0.05.”

Wosihinka suggests that patients who begin therapy following high advertising for the given

drug class appear to be more compliant because they were the ones to initiate the process, as a

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result of the motivating advertisements. Again, expectations of the drugs may lead to better

outcomes through improved diagnosis and improved adherence to the therapy.

3.13 Medicalizing

Medicalizing is a term used to describe the process in which medical problems are

redefined to expand the number of patients who may benefit from pharmaceuticals. This may

include “turning ordinary ailments into medical problems, seeing risks as diseases, and framing

prevalence estimates to maximize potential markets” (Moynihan et al, 2002). DTC

advertisements may be medicalizing certain disease: 39% of advertisements encouraged people

to consider a medical cause for their experiences (Woloshin et al, 2001). These messages may be

socially beneficial when they target hyperlipedimia or hypertension, but may be inappropriate

when discussing the emotional trauma of everyday experiences. According to Moynihan et al

(2002),

“inappropriate medicalizing carries the dangers of unnecessary labeling, poor treatment decisions, iatrogenic illness, and economic waste, as well as the opportunity costs that result when resources are diverted away from treating or preventing more serious disease….The costs of new drugs targeted at essentially healthy people are threatening the viability of…insurance systems” and increasing costs for private health plans.”

The rise in unnecessary prescriptions, both from medicalizing and inappropriate prescribing, are

one of the many costs associated with DTC advertising.

3.14 Costs of DTCA.

There are several costs that should be considered when examining the effects of DTCA:

first the cost of the advertising, which may influence the price of medications. Then one must

examine how advertising affects the efficiency of prescribing: do advertisements help to

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facilitate the spread of information such that patients receive appropriate medications that

prevent hospitalization and other costly care; or, do pharmaceutical markets expand to patients

through medicalization?

Advertising accounts for a little under one fifth of pharmaceutical companies operating

expenses each year. Of this budget, only about 16% is directed toward consumers, with the

majority of advertising directed to physicians through office detailing and free samples (Federal

Register Comment, Bureau of Consumer Protection et al, 2003). Several studies have shown that

this advertising does not lead to an increase in the price of advertised pharmaceuticals.

According to Pfizer, “sellers typically engage in advertising in order to increase sales – and when

that occurs, the cost of advertising is spread over a larger pool of sales units, thereby reducing

the per-unit overhead costs accordingly. Moreover, increased sales can both recover advertising

costs and increase the total return to the manufacturer of the advertised drug.” (Federal Register

Comment, Pfizer, 2003) Rosenthal et al (2002) confirmed that relative to sales, total spending on

promotion has remained fairly constant at 14 to 15 percent. This implies that the major costs and

benefits associated with advertising focus on its ability to disseminate information to patients and

physicians.

Several studies have shown that advertising can engender or exaggerate product

differentiation, which creates barriers to entry in the market. Advertising for product’s whose

quality and impact can be discerned prior to purchase through search qualities (visual, tactile, or

analytical inspection) are usually subject to informational appeals. Products whose qualities can

only be observed through consumption have experience qualities, and are usually advertised

through persuasive appeals. The brand loyalty that is generated through both types of advertising

may reduce price elasticity of demand, and also reduce consumers’ and physicians’ search costs.

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The advertisements may also serve to create brand loyalty such that it becomes a barrier to entry

for generics. The pharmaceutical market is particularly vulnerable to such rent-seeking outlays

due to the regulations surrounding the prescription of medications.

Though demand for pharmaceuticals is conventionally considered an inelastic good,

Hurwitz et al (1988) showed that demand is elastic in the absence of promotion. This partially

can be explained by studies that show physicians beliefs about specific drugs are closely aligned

with their advertising claims, rather than drug performance measures. Rizzo (1999) tested this

hypothesis that advertising decreases the price elasticity of demand, which may cause consumers

to pay a higher price for advertised pharmaceuticals, by analyzing the prices of brand name

antihypertensive drugs marketed in the United States between 1988 and 1993. In the absence of

any detailing, price elasticity ranges from -1.82 to -2.67, indicating that sales respond to changes

in price. When products are advertised, price elasticity falls to -1.26 to -2.11. Through this is still

within the elastic range, detailing stock reduces the price elasticity of demand. Price elasticity

becomes inelastic with short-term changes in detailing flows.

Furthermore, advertising while the drug is still under patent has lasting effects once the

drug faces generic competition: an additional year of advertising under patent leads to an

additional 1.6% of market share for the leader after the patent has expired This goodwill is

generally used to substitute for promotional activities post patent, rather than enhancing market

share (Hurwitz et al, 1988).

Vogt and Bhattacharya (2003) created a model which indicates that drug prices are kept

low and advertising expenditures are initially high to build public exposure and experience with

the drug. As this knowledge base grows, prices rise and advertising expenditures fall. Their

model confirms Hurwitz et al (1988) report that doctors often form prescribing “habits,”

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implying that pharmaceutical companies should invest in building knowledge base and

accessibility in early stages, and then raise prices as demand for the drug increases to exploit the

“knowledge stock.”

According to Coscelli (2000), the brand loyalty and habit persistence of doctors are

responsible for the stickiness of the pharmaceutical market, which causes consumers to pay a

premium for the pioneering brand instead of switching to a generic once the patent expires. This

first-mover advantage implies that consecutive entrants have to advertise at an increasing rate to

gain market share, which is consistent with the empirical data for drugs in many classes. The

decreasing return on advertising for consecutive firms re-enforces Hurwitz et al notion that firms

can build-up a "good will" asset through advertising that helps to maintain its market share.

Overall, marketing elasticity of demand for DTCA ranges from 0.096 to 0.114, meaning

10% increase in DTCA leads to a 1% increase in sales when all else is equal. Between 1999 and

2000, the 12% of the growth in total prescription drug spending, or $2.6 billion, can be attributed

to DTCA, yielding $4.20 for every dollar spent on DTC advertising (Rosenthal et al, 2003). A

study by Zachry et al (2002) showed that advertising increased both the rate of diagnosis and

prescription for advertised drugs and the condition they treat. Though the authors do not imply a

causal relationship, they found that every $1000 increase in advertising of antilipemics resulted

in the diagnosis of 32 to patients and 41 patients receiving a prescription for hyperlipidemia.

Zocor specific advertising also raised the prescription for Zocor specifically.

Clearly the informational content and persuasive appeals in the advertisements lead to

prescriptions and stickiness within the pharmaceutical market. Kravitz et al (2005) suggest that

the increase in advertisements is for both under diagnosed conditions and for therapies at the

margin of clinical benefit. In New Zealand the government noted that prescription drug

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advertisements tend to shift demand from older therapies, to newer more expensive medications.

“For example, there was a significant shift in the mix of Metered Dose Inhalers from

beclomethansone to flucticasone (Flixotide) following Glaxo Welcome’s Fluxotide DTCA

campaign” (Wilson, 2003). This is just one example of the significant costs associated with

DTCA.

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4. Study Design

Advertising in general, but specifically within the pharmaceutical sector, is not a

homogenous good. Therefore, it is not possible to study the effects of advertising by a particular

brand or drug class without measuring the quality of the prescription drug advertisements. In this

study, we examine “quality” from a public health perspective: measuring the content of the

information provided in the advertisement as well as the accessibility of that information by the

consumer.

Print advertisements were examined for osteoarthritis and hyperlipidemia that were

published between January 1999 and September 2004. These two drug classes were chosen

because they represent the two most heavily advertised prescription drug classes during the study

period. They also characterize vastly different types of conditions: osteoarthritis is a disease that

may cause patients a significant amount of pain, and represents a drug class that is likely highly

influenced by the emotional expectation of pain relief; hyperlipidemia is a condition with no

symptoms which is widely under diagnosed throughout the population, and represents a class

that is likely to be influenced by educating the public about the condition.

COX-2 drugs, a common treatment for osteoarthritis, have been under great scrutiny

since December 2004, when Merck voluntarily removed Vioxx from the market after it was

publicly shown to increase the risk of heart attack. Though this has the potential to introduce bias

into the study, we felt the specific nature of the rating categories would prevent the negative

connotations subjects may have garnered about Vioxx to influence the results significantly.

Furthermore, studying the COX-2 drug class is particularly interesting, because it may shed light

on the role of DTC advertising in extending the use of these drugs to patients who should have

taken non-steroidal anti-inflammatory (NSAIDs, such as ibuprofen).

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Print advertisements for medications in these two drug classes were collected from

several popular magazines which print many DTC advertisements. These magazines generally

have readership that are inclined to be more aware of DTC advertisements (women and people

over 65), but represent a wide variety of interests. The magazines that were used to collect the

print advertisements include:

People US News and World Report Redbook Time Reader’s Digest Newsweek

64 DTC advertisements were collected, which were part of 32 distinct ad campaigns.

Often a particular advertisement will have several different versions, in which only the picture

and tagline have been changed. This is likely done to attract different audiences to the same

information. For instance, advertisements will tailor one image to males and another image to

females. In our study ad campaigns constitute advertisements that are identical except for the

image and tagline. The timing of each ad campaign was recorded, generating a list of the

advertisements that appeared for drugs within these two drug classes between January 1999 and

September 2004.

The advertisements were photocopied from the magazines, and then placed into a binder.

Only the body of the ad, and not the accompanying brief summary were given to raters because

“it is commonly believed that consumers pay little attention to such fine print, and previous

research indicates that risk information presented in full disclosure format similar to typical brief

summaries has little effect on recall” (Roth, 1996). The portion of each advertisement containing

risk information was bracketed on each advertisement so that raters could judge the quality of

benefit and risk information separately. An ad ID was also generated for each advertisement.

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Each ad was assigned an individual number, and also a letter that corresponded to the ad

campaign associated with it. This binder, along with a set of instructions, and 40 copies of the

assessment tool was given to study participants to rate the presentation of the information in the

drug advertisements.

15 participants were recruited through a campus e-mail flyer to rate the prescription drug

advertisements. In exchange for rating the ads, which took approximately four hours, participants

were compensated with a $100 American Express Giftcard. Each participant was asked to rate

all 64 advertisements. A complete assessment was used for each ad campaign, and a shortened

assessment was completed for the other advertisements that belonged to the same ad campaign.

(The shortened assessment was created to minimize the fatigue on raters in judging identical

characteristics, such as font size, for ads within the same ad campaign.) The advertisements were

selected to appear in a different random order for each study participant. A computer program

was written that first randomized the order of the distinct ad campaigns, and then randomly

ordered the advertisements within each ad campaign. The response rate for each category and

each ad was nearly 100%.

4.1 Methodology for Rating Quality of Advertisements: The DTC Assessment

A content analysis was used to quantify the advertisement quality. With the help of the

Department of Drug, Marketing and Communication at the FDA, a DTC assessment was created,

which consists of two parts:

Presentation Assessment: This survey is administered to consumers to measure the ease

of accessibility of information within the advertisement. Categories include font size,

headings, and spacing.

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Content Assessment: This portion of the survey is administered by an individual

familiar with the advertisements. It compares the informational content in the

advertisement to the drug’s Patient Package Insert (an informational pamphlet

accompanying a prescription when it is given to patients) as well as information about the

disease taken from WebMD. Categories include side effects, efficacy, and symptoms.

The two assessments emphasize the importance of both the content and presentation of

information in the advertisement. From a public health perspective, it is important for patients to

create proper expectations from the advertisement. Therefore, we rate the amount of information

pertaining to the disease the drug is indicated to treat, the benefits of the drug, and the risks

associated with the drug. Beyond the informational content, it is necessary to rate the

presentation of the information as well, because DTC often advertisements emphasize the benefit

information and minimize the risks. For instance, pharmaceutical companies may print the risk

information that is mandated by the FDA (warnings, contraindications, and side effects) in

smaller font at an obscure placement within the ad to make it relatively less accessible to the

reader. (Figure A4.1. An ad for Levitra provides a good example.) Drastic differences in these

qualities may constitute a breach of the “fair balance” requirement by the FDA. Even when “fair

balance” was not violated, “benefit information was better recalled than risk information”

(Wogalter et al, 2002). This suggests that it is crucial for advertisements to make the risk

information at least as accessible as the benefit information in order to achieve true balance.

A study by the FDA on the format of the brief summary (the page accompanying the drug

ad that describes in more detail and the risk information) revealed consumers have specific

preferences in DTC advertisements. These criteria can be found in Table A4.1.

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Wogalter et al (2002) showed that consumer preference relate closely with the ability to

recall information. “The concurrence of the preference/performance measures is consistent with

theory concerning learning styles and schemas, that individuals prefer presentation formats that

are consistent with their learning styles…advertising research indicates that preference reflects

likeability, which in turn positively influences recall.” In fact, previous studies have shown that

“patients are more likely to comply with recommendations for use when the information is

communicated directly and in an understandable manner” (Wogalter, 2003). Therefore, we

incorporate many of the consumers’ preferred categories into the DTC assessment, because

preference seems to be a good proxy for the effectiveness of informational transfer from the

advertisement.

4.2 Presentation Assessment

The Presentation Assessment contains 24 categories, and asks for both objective and

subjective responses to the advertisements. Initially, raters are asked to judge the overall quality

and balance of the ad as well as the pertinence of the image and tagline. Afterwards, they are

asked to objectively rate the benefit and risk information separately on 15 different criteria,

which ask questions about the use of headings, font, color, and text blocks. The assessment asks

for raters to judge the benefit and risk information separately to determine whether both types of

information meet a basic presentation threshold for accessibility. This format also allows

comparison of the relative accessibility of the benefit and risk information. Finally, the survey

incorporates a section in which the raters are asked to give their subjective opinion on the

accessibility of the risk and benefit information. This subjective comparison gives raters the

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opportunity to convey any preferences that may not have been made explicit by the rating criteria

that were objectively delineated.

The presentation assessment begins by asking the rater to judge the overall ad design.

This prompts the rater to examine the ad and provide a first impression. Next, the rater is

prompted to read the advertisement in order to compare the language used to frame the risks and

the benefits. The risks and benefits should be framed such that they are both easy to read and

equally captivating. For example, if the active pronoun “you” is used to described the benefits,

then the risk information should also use the personal pronoun. Afterwards, the rater is asked to

judge whether the location of the risk and benefit information makes them equally prominent. If

the risk information is not located in a place with equal emphasis, consumers may glean past the

information completely. Studies have shown many older adults do not recall any risk information

incorporated into an advertisement.

Finally, the rater is asked to evaluate the pertinence of the image and tagline to the

product that is being advertised. Since images offer more stimulation than text, it is important to

determine whether this component of the advertisement is relevant to either the disease or

therapeutic benefit of the drug. Images that just depict “happy people” may create the

expectation that a particular prescription drug will enhance a patient’s quality of life in general,

not the quality of life in regard to a particular condition. Similarly, the taglines of advertisements

are often quite memorable, and should also be tailored to the disease or benefit of the drug, not

just general happiness. Simply depicting happiness may increase a patient’s expectation of a drug

without regard to the therapeutic benefit that the drug actually provides. Though these images

cannot be directly regulated by the FDA due to a variety of complex legal issues, it is important

to measure the impact of the expectations created by these depictions. To simplify the rating of

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images, raters were simply asked to determine whether the image and tagline referred to

happiness in general, or whether they were specific to either the disease or therapeutic benefit

one would expect to receive from the drug.

The objective categories in the DTC assessment align closely with both the preferences

revealed by the FDA survey and work done by various researchers to determine the format

characteristics that enhance information recall. The first part of this section measures the use of

headings both to highlight important information and to segment text into smaller text blocks.

According to Wogalter et al (2002), “the presence of physical features (eg, color) that distinguish

the risk information from other text facilitated knowledge acquisition.” Likewise, Marrow et. al

(1995) showed that information contained in lists were more effective than when formatted in

paragraphs. The “headings” ratings combined with the use of bullets measures the use of lists

within the advertisements.

The next broad category within the assessment addresses the quality of the font used to

convey information. Raters are asked to first examine how easy it is to read the font itself, and

whether the letters are dark enough. Next they rate the size of the font, which has a significant

effect on recall according to Wogalter et al (2003). “Performance was significantly better in the

medium and large print conditions than in the small print conditions – with the latter not

differing from [no information at all].” Besides the size of the text, raters are also asked to

determine whether the spacing between the lines and between letters is adequate. Young et al

determined that the width of the characters in printed warnings affects the perceived legibility

and reading speed, while Hartley showed that increasing the vertical spacing between text

facilitated reading comprehension. Together these five characteristics of font are instrumental in

making the text inviting, and thereby accessible to readers (Wogalter, 2003).

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The raters are also asked to rate several categories that probe how different ad elements

distract the reader from the text. First, the rater determines whether the color scheme and contrast

between the text and the background facilitates reading. Next, the rater determines whether the

image distracts readers from focusing on the text. Finally, raters are asked whether there is

enough space between the text and other features, and if the width of the paragraph is pleasing.

(This probes the idea that there should not be “one giant text block”.) Taken with the measures of

font and headings, these categories quantify many elements that affect a reader’s initiative to

read a text and their ability to recall information.

The categories in the presentation assessment incorporate nine of the eleven categories

mentioned by the FDA focus groups. (Table A4.1) The presentation assessment does not rate

whether the drug name is clearly visible at the top of the page, because this was deemed to be a

content criterion. (FDA regulations require the name of the drug be prominently displayed along

with the chemical name.) The presentation assessment also does not ask raters to quantify the use

of bullets. This quantification can easily be determined by a single individual, and therefore was

incorporated into the content assessment in order to reduce the length of the survey that was

administered multiple times to survey participants. (Several other “presentation” categories were

shifted into the content assessment for the same reason. These include whether the text was

justified, use of both upper and lower case letters, and a measure of the reading level of the text.)

The majority of the categories are scored out of either one or two points. The use of a one

point measure makes it easier for raters to determine whether an ad meets the specific criteria.

Though the assessment tries to make many criteria as objective as possible, personal taste may

still effect the perceived appearance of the advertisement. Compressing the grading scale forces

people to make simpler decisions about rating each criteria, which increases the inter-rater

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reliability and the validity of the study overall. Several categories were listed out of two points

with 2 corresponding to the most sufficient advertisement, 1 corresponding to a somewhat

sufficient advertisement, and 0 corresponding to an advertisement that does not meet the criteria

at all. Two categories, font size and contrast have a larger scale range to represent the much

larger variance within these two categories. Since the absolute scores are not designed to form a

total “presentation” score, the absolute value of the ratings of each category have no bearing on

the relative importance of each category. Instead, percentages from each category should be

summed in order to obtain an overall score.

The Presentation Assessment aims to measure the overall impact of the advertisement as

well as the accessibility of the information within the advertisement. Ideally, advertisements

would have an appealing design with images and taglines pertinent to the treatment of disease,

while making the informational content of the advertisement easily accessible.

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Thank you for participating in my study. You will be asked to rate prescription drug advertisements on objective and subjective criteria. The following binder contains 33 different “ad campaigns” with some ads having multiple versions (i.e. they are several versions of a particular ad campaign with different pictures.) For each ad please fill out the DTC Assessment, which has two parts: the first part asks you to rate particular criteria, and the second part asks your subjective opinion of the advertisement. If there are several ads within the same ad campaign, please fill-out the remaining questions on page 2 corresponding to how the different images effects the quality of the ad within the campaign. (There is a separate page with just this portion of the questionnaire if there are more than three ads within a given campaign.) Here are some suggestions for the DTC Assessment:

1. Begin by turning to the back of the ad and locating the AD ID, which is written on a blue or red sheet of paper. The AD ID is a number, followed by a code. Here is an example: #10000 ZZ1. Please write this in the box on the upper left hand corner of the survey.

2. The advertisements have been divided into two categories: benefit and risk. The risk

information has been marked by lines and labeled on each ad. The benefit information consists of the remainder of the advertisement. Please rate some basic feature of the ad, such as the “Ad Design”, “Framing” and “Location” of the information.

3. Please rate the image and the tagline: circle SPECIFIC if the image relates directly to the condition or the benefit of the drug (i.e. a healed wound for a bandaid advertisement); otherwise the image is considered GENERAL. Similarly, if the “tagline” or the “slogan” of the ad relates specifically to the condition or the benefit, please circle SPECIFIC, otherwise circle GENERAL.

4. Next please rate the benefit information and the risk information separately based on the

following categories: Headings

1 pt: Use of bold letters, large font or different colors to make the headings stand out. 1 pt: Headlines provide information that is useful 1 pt: The headline directly relates to the text that follows 1 pt: Good ratio of headlines to text

Font 5 pt: Size of the font (Please see scale on survey – the scale is a crude outline to scoring – please score the size of your font at your discretion, taking the scale only as a suggestion.)

Directions to the Presentation Assessment

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Again, these are just rough guidelines – please rate the color and contrast at your discretion, taking these only as suggestions. Color:

1 pt: Contrast “Dark Colored” text against “Light Color” Background Dark Colors Light Colors Blue Orange Violet Yellow Purple Green Red Blue-green

Contrast: 3 pts: There is enough contrast between the text and the background. (Please see examples.)

EXAMPLES: 4 pts 4 pts 4 pts

1 pt 2 pts 3 pts

62

5. Please turn to page 2 of the survey, and give your opinion on the various broad categories

within the advertisement. Specifically, within these broad categories does the presentation of the information make the Benefit section (B) or Risk section (R) easier to read. If they are the Same, please circle (S).

6. You have completed rating one ad. Please turn to the next ad, and check the AD ID. If the

AD ID has the same letter as the previous ad (ZZ 2 in our example) please proceed to the lower half of page two and only fill out certain categories for ads within the same “campaign.” If you need more of these “brief versions” there is an extra page with just these categories.

I have included a sample “grading” of a Levitra ad for your reference. Thank you very much for your help. Please let me know if you have any questions or suggestions at (xxx) xxx -xxxx or at ealmasi@stanford.edu.

63

DTC Assessment (Print)

Benefit RiskHeadings Stand apart from text (i.e bold/different color)

Headlines provide good information Headlines relate to the text that follows Good ratio of headlines to text

/1 /1 /1 /1

/1/1/1/1

Font Font is easy to read Letters are dark and wide enough 0 pt: Size of Font or smaller

Size of Font 2 pt: Size of font 3-4 pts: Size of font 5 pt: This size of font or larger Adequate space between letters Adequate space between text lines

/1 /1

/5

/1 /1

/1/1

/5

/1/1

Color and Contrast

Between color of text and background 0-1pt: Color Scheme 0-3 pts: Contrast

/1 /3

/1/3

Image

Does the image distract your from focusing on the text? 0 pts: Very distracting- difficult to focus 1 pt: Somewhat difficult to focus 2 pts: Not distracting - easy to focus

/2

/2Text Block Enough space between text and other features.

Pleasing width of paragraphs. /2 /1

/2/1

Content Order of Information /1 /1

Ad Design Is the overall layout of the ad easy to read?(0 pts: No; 1 pt: Somewhat; 2 pts: yes)

/2Framing Are the risks and benefits framed in

language that is equally accessible to you? (0 pts: No; 1 pt: Somewhat; 2 pts: yes)

/2

Location Are the risks and benefits located such that they receive comparable emphasis? (0 pts: No; 1 pt: Somewhat; 2 pts: yes)

/2

Image

Depicts Benefit of drug or Condition

GENERAL

SPECIFIC

Tagline

Describes Benefit of drug or Condition

GENERAL

SPECIFIC

AD #: ________________________

Ad Rater ID: _________________________

64

Subjective Impressions: Please circle whether you thought the following made it easier to read the information in the Benefits section (B), the Risks section (R), or if they were the same (S).

____________________________________________________________________ For ads in the same ad campaign (i.e. AD ID starts with the same letter.) In these ads, all the information provided is the same, the only difference is some of the promotional text and the image. AD ID____________________________________________

AD ID____________________________________________

Headings: Segment the text into easily understandable parts. R B S Font: The text features make the ad easy to read. R B S Color and Contrast: The color and contrast make the text easy to read. R B S Image: The image does not distract you from focusing on the text. R B S Text Block: Shape and location of text block makes text easy to read. R B S Content: The order of the information provided. R B S Accessibility: The information is easily accessible. R B S

Image depicts Benefit of drug or Condition

GENERAL

SPECIFIC

Tagline describes Benefit of drug or Condition

GENERAL

SPECIFIC

Color and Contrast

Between color of text and background 0-1pt: Color Scheme 0-3 pts: Contrast

/1/3

/1/3

Image

Does the image distract your from focusing on the text? 0 pts: Very distracting- difficult to focus 1 pt: Somewhat difficult to focus 2 pts: Not distracting - easy to focus

/2

/2

Image depicts Benefit of drug or Condition

GENERAL

SPECIFIC

Tagline describes Benefit of drug or Condition

GENERAL

SPECIFIC

Color and Contrast

Between color of text and background 0-1pt: Color Scheme 0-3 pts: Contrast

/1/3

/1/3

Image

Does the image distract your from focusing on the text? 0 pts: Very distracting- difficult to focus 1 pt: Somewhat difficult to focus 2 pts: Not distracting - easy to focus

/2

/2

65

4.3 Content Assessment

The content assessment measures the quantity of information presented within the advertisement.

This incorporates both the information that must be included in all advertisements according to FDA

regulations, as well as information that should be included in advertisements from a public health

perspective. The content assessment includes five distinct categories: regulated benefit information,

regulated risk information, other benefit information, disease information, and objective presentation

details. Regulated Benefit information includes:

• Indication (name of condition that the drug treats)

• Approved patient population (the patients for which the FDA has approved the drug)

• Required supportive behaviors (behaviors that the FDA indicates must be practiced while taking

the drug, such as diet for cholesterol lowering medications)

• Contaminant therapies (other drugs that should be taken with the advertised medication)

• Intended use of the drug (for example, whether the drug is used to prevent asthma attacks or at

the time of an asthma attack)

• Onset of effectiveness (the time it takes for the drug to being working)

• Length of effectiveness

• Duration of treatment

Other categories may fall into the regulatory domain if they are included within “indication” of the

patient package insert, or when regulators believe the advertisement would be misleading if the

information was omitted. For example, Muse, a medication used to treat erectile dysfunction, was

required to include the drug delivery method, because regulators felt patients would be surprised to learn

that it was delivered by injection. Other categories that may fall under the regulatory domain include

66

symptom information, and other benefit information (a category that includes the discussion of positive

side effects, such as a decrease in acne for patients who use oral contraceptives.)

The benefits section includes categories for the success rate of the drug, “other benefit information”,

long term benefits, the mechanism of action, drug delivery method, time to onset of action, and

supportive behaviors. Together these categories describe the basic information a patient should know

about the effectiveness of a medication. Studies by Woloshin et al (2004) show that patients are much

better able to determine the effectiveness of the advertised medication from advertisements that contain

a benefit box, which compares the effectiveness of the advertised drug to either other therapies or

placebo. By providing the concrete benefit information described by the seven benefit categories,

readers may become informed consumers who have better tools to judge the effectiveness and

appropriateness of a medication.

Similarly, by including disease information readers may be better able to determine whether they or

someone they know is afflicted by a certain condition. The disease information section includes

categories on the symptoms and risk factors. Incorporating this information into advertisements is

essential for advertisements to achieve their ability to motivate patients with under-diagnosed conditions

to visit their physicians.

Finally, the risk section incorporates categories that are mandated by the FDA: warnings,

contraindications, and the most common side effects. The rater also determines the strength of the

headline used to attract the reader to the risk information (please see the directions for the content

assessment) and whether the advertisement compares the prevalence of these side effects to placebo.

The content analysis also includes a few presentation categories that would be unnecessarily tedious

for survey participants to rate. These include whether the text is justified, if it uses bullet points to

segment the text, and whether the text is written in both upper and lower case letters. The text of both

67

the benefit and risk information is also entered into a computer to determine the Flesch-Kincaid Reading

Level. Kaphingst showed that materials for the general public should be written at or below an eighth-

grade reading level (Kaphingst et al, 2004).

Lastly, the content analysis includes a measure of the informational and educational value of the

image and tagline. The image and tagline should not contradict any information within the

advertisement or exaggerate the benefits one would expect to receive from the medication.

The content assessment may be rated by just one individual, by making direct comparisons

between the information contained within the advertisement, the Patient Package Insert, and disease

information from WebMD. The Patient Package Insert is patient information approved by the FDA and

provided to patients with every prescription. It contains information on both the benefits and risks

associated with the medication. WebMD is a popular and reliable source for basic disease information.

By making direct comparisons between these two sources and the advertisement, one may deduce the

degree to which the advertisement parallels the information available about both the disease and the

advertised drug without introducing any bias. As with the presentation assessment, the relative

weightings of each category are insignificant, as the percentage of information within each category is

summed to form the total content score. However, an advertisement may have a high content score and

still be in violation of FDA regulations if it is missing key information within the regulated categories.

The benefit, risk, and disease categories within the content assessment describe the basic

information patients should have before making decisions about prescription medications. By providing

this information, the risk of inappropriate prescribing as a result of heightened patient expectation or

misinformation is minimized.

68

The following descriptions should help you rate the content of advertisements using the DTC Assessment survey. If you have any questions, please contact Elizabeth Almasi at ealmasi@stanford.edu or by phone at (xxx) xxx-xxxx. Not all categories are relevant to each medication. If the category does not pertain, please write N/A in place of the score. In these instances, the category will be removed from the total, and the content will only be measured by the categories that pertain to the medication. Risk Information The FDA approves the warnings, contraindications, and most common side effects that should appear in the Patient Package Insert. Please use your best judgment to determine whether the information regarding risk information is presented within the advertisement.

Benefit Information The benefit information has been broken into two categories: information that must be included in the advertisement according to FDA guidelines (which are included in the Indication section); and other information that would ideally appear within the body of the advertisement. Indication 3 pts: Names the condition that the drug treats. Indication 3 pts: Describes the appropriate patient population. Deduct 1

pt. for each error or omission. Indication 3 pts: Lists the required supportive behaviors (ex. Diet and

exercise for statins) Deduct 1 pt. for each behavior omitted. Indication 3 pts: Lists the therapies that should be taken in conjunction

with the advertised medication. Indication 2 pts: Indicates whether this is a second line therapy.

(Ex. Asthma medications such as Singulair versus inhalers.) Indication 2 pts: Indicates the onset of the effectiveness of the drug. Indication 2 pts: Indicates the length of effectiveness of the medication. Indication 2 pts: Indicates the duration of the treatment time.

Warnings Deduct 2 pts. For every relevant warning that is omitted. (ex. No need to include warnings that some people may be allergic to ingredients.)

Contraindications Deduct 2 pts. for every relevant contraindication that is omitted.

Most Common Side Effects

Deduct 2 pts. for every relevant common side effect that is omitted.

Most Severe Side Effects

Deduct 2 pts. for every severe side effect that is omitted in the advertisement.

Directions to Content Assessment.

69

*Other Benefit Information

Includes other benefit information for taking this particular medication within the drug class, such as mentioning fewer side effects or less frequent dosing requirements. Information should not be vague or misleading.

*Drug Delivery Information

Must be included if the deliver method varies from the expected form. (ex. Muse is only injectable.)

Success Rate Gives indication of benefit. 2 pts: Vague terms 4 pts: Explicitly states absolute risk reduction (i.e. Reduce risk of disease by 40%) 5 pts: Explicitly states number needed to treat (ex. need to treat 100 people before averting 1 case), or absolute risk reduction in conjunction with the actual prevalence of disease with and without the use of the medication. (ex. A 2% reduction in risk from 5% to 3%.)

Long Term 3 pts: Mentions the disease may have long term effects 5 pts: Explains specific benefits of early treatment

Supportive Behaviors

Describes behaviors that aid treatment or reduce complications. Points can only be awarded for information that is not required by the FDA. 2 pts for each piece of additional information. If information is stated in a confusing way, only award 1 pt. If information is presented in a misleading fashion do not award any points.

Mechanism of Action

Describes how the drug works in the body.

Time to Onset of Action

Estimates time before effects may take effect. (Extra point awarded for most precise information.)

*Symptoms Describes noticeable symptoms or states that symptoms are invisible. Deduct 2 pts for any major symptoms omitted.

*Risk Factors 5 pts: Describes behaviors that may cause the condition (i.e. smoking) 5 pts: Describes other risk factors (demographic groups, genetic) Deduct 2 pts. For every major behavior or risk factor that is not included within each category.

*These categories may fall within FDA regulation. For example, symptoms are considered regulatory if the indication is for a condition not well known to the public. Risk factors are considered regulatory if they are described within the indication section of the Patient Package Insert. Drug Delivery Information becomes regulatory in cases where omission may mislead the patient.

70

Image and Banner: Image: Patients Depicts the proper patient population. Deduct 3 pts. for every

image that contradicts the patient population listed in the indication. Deduct 1-2 pts. for images that appear to be misleading (patients appear to young, patients participating in activities that would not be possible given their condition).

Image: Benefit or Condition

If image depicts condition: Image in no way contradicts information about the indication or side effects, or other information in the ad. (ex. In birth control advertisements, woman should not wear all white because spotting is often a common side effect. In statin advertisements, it should not depict patient consuming fatty foods and using the medication.) 0 pts: Image contradicts information 2 pts: Minor contradictions between ad and information (ex. Person appears just a bit too young)

4 pts: No contradiction, but not relevant to disease 5 pts: No contradiction and relevant to disease If image depicts Benefit: Benefits depicted are obtainable by majority of people who suffer from the condition. 0 pts: Benefits are exaggerated 2 pts: Benefits are only expected for a small fragment of users (i.e. upper quartile) 5 pts: Benefits can be obtained by majority

Banner: Stating Benefits

Benefits stated are obtainable by majority of people who suffer from the condition OR the pain described is a typical experience within this population who suffer from the condition. 0 pts: Benefits exaggerated OR pain is described vaguely to include a greater patient population 2 pts: Benefits are only expected for a small fragment of the users (i.e. upper quartile) OR pain described is typical but also is not specific to the given disease 5 pts: Not relevant to condition, simply uplifting statement 5 pts: Benefits can be obtained by majority OR pain accurately describes symptoms drug treats

71

Content Assessment.

Names condition drug treats /3 Patient Population /3Required Supportive Behaviors /3Concomitant Therapies /3Severity: Second Line Therapy /2Onset of effectiveness /2Length of effectiveness /2

Indication

Duration of Treatment /2* Other Benefit Information

Makes superiority claim of fewer side effects or benefits of side effects without being too vague or misleading (ex. less frequent dosing requirements)

/5

*Drug Delivery Information

If the delivery method varies from expected, this information must be disclosed. (i.e. Muse in inject able form)

/2

Success Rate Gives indication of benefit: either rate over population, or average benefit per person (2 pts: vague terms,5 pts: value)

/5

Long Term 3 pts: Mentions long term effects 5 pts: Explains benefits of early treatment (more specific)

/5

Supportive Behaviors

Describes behaviors that aid treatment or reduce complications beyond those required

/5Mechanisms of Action

Describes how drug works in the body

/1

Time to Onset of Action

Estimates time before effects may be

/2*Symptoms

Describes noticeable symptoms or states that symptoms are invisible (Deduct 2 pts for any major symptom omitted)

/5(Deduct 2 pt. for every major missing behavior or risk factor) Describes behaviors that may cause the condition /5

*Risk Factors

Describes other risk factors (genetic, demographic groups) /5

Justification Text is not justified /1

/1

Bullets Use of bullets to segment text

/2

/2

Case Use of both upper and lower case letters

/1

/1

Reading Level

Flesch-Kincaid Reading Level

/12 /12Active Voice

Percentage Use of Active Voice /100 /100

Warnings Deduct 2 pts for every relevant warning omitted

/7Contra-indications

Deduct 2 pts for every relevant contraindication omitted

/6

Most Common Side Effects

Deduct 2 pts for every relevant common side effect omitted

/7

Risk Headline Headline offers appropriate signals about risk information

/2Placebo Compares rate of side effects

to placebo /2

Benefit

Risk

72

The following content information should have been included in advertisements for drugs in the COX-2 drug class to receive a perfect score:

Indication: Osteoarthritis Pain /3 Patient Population: -- /3Required Supportive Behaviors: -- /3Concomitant Therapies: -- /3Severity: Second Line Therapy: -- /2Onset of effectiveness: -- /2Length of effectiveness: 24 hours /2

Indication

Duration of Treatment: 18 months /2* Other Benefit Information

24 hour pain relief from 1 tablet

/5

*Drug Delivery Information

--

/2Success Rate

/5

Long Term There is no cure for osteoarthritis, but this may prevent symptoms from effecting quality of life.

/5

Supportive Behaviors

Exercise to maintain the strength of muscles supporting joints and diet to maintain ideal weight.

/5Mechanisms of Action

Targets the COX-2 enzyme. /1

Time to Onset of Action

--

/2*Symptoms

Joint pain, swelling, inflammation

/5(Deduct 2 pt. for every major missing behavior or risk factor) Obesity, injury, joint overuse

/5

*Risk Factors

Hereditary /5

Warnings Pregnancy, Liver Problems, Kidney Problems

/7Contra-indications

Allergic reactions to sulfanomides, or asthmatic reaction to aspirin or other NSAIDs

/6

Most Common Side Effects

Indigestion, diarrhea, abdominal pain

/7

73

The following content information should have been included in advertisements for drugs in the statin drug class to receive a perfect score:

Indication: High Cholesterol, Heart Disease

/3

Patient Population: -- /3Required Supportive Behaviors: Diet

/3

Concomitant Therapies: -- /3Severity: Second Line Therapy: -- /2Onset of effectiveness: -- /2Length of effectiveness: -- /2

Indication

Duration of Treatment: Indefinite /2* Other Benefit Information

--

/5

*Drug Delivery Information

--

/2Success Rate Percentage decrease in LDL, total

cholesterol, triglycerides

/5

Long Term Statement that lowering cholesterol has been shown to reduce the risk of heart attack and stroke

/5

Supportive Behaviors

Exercise (and diet, mentioned above)

/5Mechanisms of Action

Targets cholesterol intake, or internal cholesterol

/1

Time to Onset of Action

--

/2*Symptoms

Should state there are no symptoms

/5(Deduct 2 pt. for every major missing behavior or risk factor) Obesity, sedentary lifestyle, smoking /5

*Risk Factors

Hereditary /5

Warnings Liver dysfunction, skeletal muscle pain

/7Contra-indications

Pregnancy and Nursing /6

Most Common Side Effects

Pravachol: rash, headache, diarrhea Lipitor: gas, constipation, stomach pain Zocor: rash, constipation, diarrhea, nausea Crestor: constipation, asthenia, abdominal pain, nausea

/7

74

4.4 Data

Data on monthly direct-to-consumer advertising expenditures by brand for all pharmaceuticals

was purchased from TNS Media Intelligence, a marketing company which collects over 190 million ad

occurrences a year and tracks 2.1 million brands each year (TNS Media Intelligence). They provided

monthly reports of DTCA expenditures in the following categories:

• Network TV • Cable TV • Syndicated TV • Spot TV • Outdoor • Network Radio • National Spot Radio • National Newspapers • Newspapers • Sunday Magazines • Magazines

Unfortunately the expenditure data do not differentiate between the different types of DTCA

pharmaceutical advertising (product claim, reminder ads, and help seeking ads.) However, the

expenditure data still represents a good estimate of consumer’s advertising exposure to a particular

brandname drug because product claim advertisements make up the majority of DTCA. Data provided

by TNS Media Intelligence does not include information on internet advertising or advertising claims

made in the media. However, Rosenthal et al (2002) suggests that this is a small portion of total DTCA.

Promotional expenditures to health care professionals account for the majority of marketing by

pharmaceutical companies. Promotion expenditures to healthcare professionals generally fall into four

categories: detailing to office based physicians (drug representative meeting with an office based

physician to provide information); detailing to hospital based physicians; free samples left with

physicians; and medical journal advertising. Data on these advertising efforts are collected by IMS

Health, which estimates promotional expenditures by surveying a stratified random sample of office

75

physicians (~6500) and hospital directors who track their contacts with pharmaceutical sales

representatives in the United States. A subset of the front office personnel of the physicians selected to

participate in this survey (~1250) also track the quantity of free samples provided by pharmaceutical

companies. Additionally, IMS also monitors the number of advertisements placed in roughly 400

medical journals. The publisher’s ad buys were used to obtain an estimate of the total spending on this

category.

Data on the number of prescriptions filled monthly for each brand was obtained from the

National Prescription Audit (NPA), which consists of a national random sample of

approximately 20,000 retail pharmacies, independent pharmacies, mail order pharmacies, and

mass merchandise and discount houses. These stores are sampled from the company’s pharmacy

database of more than 29,000 stores, which accounts for more than half of all retail pharmacies

in the United States. This sample accurately measures the number of new prescriptions and

refilled prescriptions for prescription medications each month.

4.5 Data Analysis

The quality ratings, both the presentation and content ratings, were entered into the statistical

software package STATA version 9 to analyze the data. Quality ratings were averaged for

advertisements that appeared simultaneously for the same drug. Expenditures on DTCA, advertising to

physicians, medical journals advertisements, and prescription rates by month were also entered. A factor

analysis using the principal factors method was performed to determine the key characteristics that

described the quality of prescription drug advertisements. Using these characteristics, the price, DTC

expenditures and prescription rates were regressed on the quality indicators.

76

5. Analysis and Results

This section examines the relationship between monthly prescription rates and DTCA

advertising. Our analysis demonstrates the correlation between monthly DTCA expenditures and the

number of prescriptions dispensed is quite poor; however, the correlation becomes remarkably good

when we adjust the DTCA expenditures according to the quality of the advertisement.

5.1 DTCA Expenditures

Between 1999 and 2004, three of the eleven drugs used to treat high cholesterol

employed DTCA persistently: Lipitor, Zocor, and Pravachol. Similarly, Celebrex and Vioxx, two

of the drugs in the COX-2 inhibitor drug class (used to treat arthritis), also relied on DTCA

continuously. These five drugs each provide many points to analyze the relationship between the

number of prescriptions, advertising expenditures, and advertisement quality.

Drug companies spent a monthly average of $6.6 million dollars on DTCA for each drug

in this sample, although there seems to be a large variation between the two drug classes, and

even among brands. (Figure 5.1 & 5.2) Average monthly DTCA expenditures were $6 million

for high cholesterol medications and $8 million for arthritic drugs. Vioxx spent the most on

DTCA, nearly $9 million each month, and even reached $29 million in one month. Within the

drugs for high cholesterol, Zocor spent the most on DTCA (an average of $6.6 million monthly),

reaching a maximum of $24 million in one month. In general, DTCA expenditures grow in the

first few months after a drug begins to employ DTC advertising, and later expenditures level off

over time. This may imply the public becomes saturated with a particular brand or message after

several months, and drug companies only use a constant level of advertising to maintain this

saturation.

77

020

0040

0060

0080

0010

000

Expe

nditu

res

(In T

hous

ands

)

01jan1999 01jul2000 01jan2002 01jul2003 01jan2005Date

Lipitor ZocorPravachol

Monthly DTCA Expenditures

Figure 5.1. Lowess smoothing of monthly DTCA expenditures for the cholesterol lowering medications from January 1999 to September 2004. Data taken from TNS Media Intelligence.

050

0010

000

1500

0E

xpen

ditu

res

(In T

hous

ands

)

01jan1999 01jul2000 01jan2002 01jul2003 01jan2005Date

Celebrex Vioxx

Monthly DTCA Expenditures

Figure 5.2. Lowess smoothing of monthly DTCA expenditures for the arthritic medications from January 1999 to September 2004. Data taken from TNS Media Intelligence.

78

5.2 Prescription Rates

Medications for arthritis and high cholesterol constitute two of the largest DTC

advertised drug classes. Between 1999 and 2004, an average1.5 million prescriptions were

dispensed each month for arthritis drugs and 2.4 million prescriptions were dispensed each

month for cholesterol lowering medications. (Figure 5.3) The number of new prescriptions for

high cholesterol drugs, especially Lipitor and Zocor, grew over time. (Figure 5.4) The number of

new prescriptions for the arthritic drugs increased precipitately between January 1999 and July

2002. This describes the response of doctors to the introduction of Celebrex and Vioxx, which

were approved by the FDA in December 1998 and May 1999 respectively. Following the initial

growth in the arthritic drug class, new prescription rates declined, especially after rumors

emerged in 2003 about the potential for these drugs to increase the risk of heart attack. The

number of prescriptions dispensed for Celebrex, Vioxx, and Pravachol has remained fairly

constant since 2002, meaning that the number of people who get a new prescription for a given

drug is approximately equal to the number of people who do not refill their prescription. (Figure

5.5) The number of prescription for Lipitor and Zocor has been growing over time, which is

beneficial from a public health perspective, since high cholesterol is one of the most under-

treated conditions.

79

010

0020

0030

0040

0050

00Pr

escr

iptio

ns D

ispe

nsed

(In

Thou

sand

s)

01jan1999 01jul2000 01jan2002 01jul2003 01jan2005Date

Lipitor ClebrexZocor VioxxPravachol

Prescriptions Dispensed By Month

Figure 5.3. Number of prescriptions dispensed for each drug by month from January 1999 to September 2004. Data taken from the National Prescription Audit.

050

010

0015

00N

ew P

resc

riptio

ns D

ispe

nsed

(In

Thou

sand

s)

01jan1999 01jul2000 01jan2002 01jul2003 01jan2005Date

Lipitor ClebrexZocor VioxxPravachol

New Prescriptions Dispensed By Month

Figure 5.4. Number of new prescriptions dispensed for each drug by month from January 1999 to September 2004. Data taken from the National Prescription Audit.

80

010

0020

0030

0040

00R

efill

Pre

scrip

tions

Dis

pens

ed (I

n Th

ousa

nds)

01jan1999 01jul2000 01jan2002 01jul2003 01jan2005Date

Lipitor ClebrexZocor VioxxPravachol

Refill Prescriptions Dispensed By Month

Figure 5.5. Number of prescription refills dispensed for each drug by month from January 1999 to September 2004. Data taken from the National Prescription Audit.

5.3 Relationship Between DTCA Expenditures and Prescriptions

Numerous studies have examined the effect of advertising dollars on prescription rates.

Figure 5.6 shows the relationship between the number of prescriptions dispensed each month and

the cumulative DTC advertising expenditure for a drug (i.e. the running sum of all DTCA

expenditures for a drug over time). This is similar to the “advertising stock” introduced by Vogt

and Bhattacharya (Vogt et al, 2003). However, a simple regression of total prescriptions

dispensed on advertising expenditures for medical journals, office detailing, and DTCA shows

that advertising dollars in each month explain very little (R-squared = 0.15) of the fluctuation in

prescription rates. (Figure 5.7) Advertising expenditures correlate somewhat better with the

fluctuation in new prescriptions (R-squared = 0.31), but still cannot fully account for the changes

81

in monthly prescription rates. This suggests the need for a measure of advertising quality to

explain short term fluctuations in prescription rates.

010

0020

0030

0040

0050

00M

onth

ly P

resc

riptio

ns D

ispe

nsed

(In

Thou

sand

s)

0 100000 200000 300000 400000 500000Cumulative DTCA Expendiutre (In Thousands of US Dollars)

Lipitor ZocorVioxx Celebrex

Total Monthly Prescriptions vs. Cumulative DTCA Expendiutres

Figure 5.6. The number of prescriptions dispensed each month according to cumulative DTCA expenditures for the given drug, from January 1999 to September 2004. Data taken from TNS Media Intelligence and the National Prescription Audit.

010

0020

0030

0040

0050

00M

onth

ly P

resc

riptio

ns D

ispe

nsed

(In

Thou

sand

s)

0 10000 20000 30000Monthly DTCA Expenditure (In Thousands of US Dollars)

Lipitor CelebrexZocor VioxxPravachol

Monthly Prescriptions vs. Monthly DTCA Expenditures

Figure 5.7. The number of prescriptions dispensed each month according to the corresponding DTCA expenditures that month, from January 1999 to September 2004. Data taken from TNS Media Intelligence and the National Prescription Audit.

82

5.4 Advertisement Quality Scores

Fifteen people were recruited to rate the presentation of the information in the

advertisements appearing for the drugs examined in this study using the DTC Assessment, which

was created in collaboration with the FDA. The content of the advertisements was rated by the

author. (A discussion of the DTC assessment can be found in section 4.)

Raters generally graded the advertisements positively, giving them approximately a 70%

score for each benefit presentation category and many of the risk presentation categories as well.

Scores within certain categories, such as image, range from 7% to 100% for different

advertisements. There appears to be significant differences between the ads among each of the

categories, although most ad scores range between 50% and 80%.

Overall inter-rater agreeability was fairly high. The agreement for any particular category

for any ad ranged from 50% to 100%, with an average agreement of 82% overall all categories.

(See Table A5.1 for the agreeability statistics.) The agreeability seemed to be higher for the

benefit portion of the advertisements, with 85% of the scores in agreement. Both the benefit

portion and risk portion (with an average of 78% agreement) surpass the 70% mark which is

used as a cutoff for data reliability. In general agreement was high for categories pertaining to

font and ad design. Raters disagreed most over the use of headlines in both the benefit and risk

portions of the advertisements. Nonetheless, even these categories met the 70% threshold.

The scores for the presentation of the risk and the benefit information are fairly equal for the

various font and color scheme categories, although on average benefit categories always scored

higher. The major difference between the presentation of the benefit and risk information occurs

in the location of the text (38% rate the location as unequal), the width of the text block (16%

score difference), and the order of the information (19% score difference). Presentation scores

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are also significantly lower for risk headlines than benefit headlines (11-19% lower for the

various categories). In fact, not a single advertisement used bullets or lists to describe the risk

information. Furthermore, the reading level of the text that described the risk information

(average Flesch-Kincaid Reading Grade: 11.75) was significantly higher than the reading level

of the text that described the benefit information (average Flesch-Kincaid Reading Grade: 8.7).

All of the advertisements contained the information mandated by the FDA, however very

few advertisements contained other information that would benefit patients. Only 11 of the 30

advertisements made any mention of the symptoms associated with the disease. More

advertisements mentioned the success rate of the drug (13 ads) and long term benefits (15 ads),

but this is still a relatively low rate. Twenty-one of the advertisements mentioned the most

common side effects, and 13 of the advertisements compared the rate of these side effects to that

of placebo.

Overall, more advertisements include risk information than quantitative benefit information,

suggesting that advertisements rely on the image and tagline to communicate the benefits of the

drug. This may be an implicit or emotionally derived message, because on average raters

believed only 36% of the images related to either the disease or the benefit one would expect

from the advertised drug. Furthermore, only 18 of the 30 images depicted situations that do not

exceed the expectation of the drug or do not contradict any of the other information contained

within the advertisement. The taglines in the advertisements seem to be much more relevant:

raters indicated 67% of the taglines related to either the disease or the benefit one would expect

from the drug. Similarly, 28 of the 30 taglines did not contradict any information within the ad or

convey unrealistic expectations.

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The DTC assessment revealed that there is a large variance in the quality of prescription

drug advertisements. In general, advertisements use an appealing font to convey both risk and

benefit information. However, the advertisements use more accessible language and better

headlines and text block design to share the benefit information contained in the advertisement.

The prominent tagline and image convey some information about the condition or disease,

however the advertisement have limited content on the symptoms of disease or the benefit of the

advertised drug. Most advertisements contain all the necessary risk information, but in less

accessible language and at a less accessible location within the advertisement. Overall, the DTC

assessment revealed people rate the presentation of the information within the advertisement as

adequate.

5.5 Factor Analysis

The criteria within the DTC assessment were grouped into several key categories. A

factor analysis was performed on each of these categories, which revealed 24 characteristics that

are important in measuring the quality of advertisement. These contain broad categories such as

comparative presentation as well as specific categories, such as headlines, font, and color scheme

for both the sections of the ad that present benefit and risk information. Information about the

risk, benefit, and disease are also found to be important characteristics. Table 5.2 contains a

description of each characteristic factor determined to be important by the factor analysis and

Table A5.3 describes the contribution of each rater category to the characteristic factors

generated from this analysis.

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Table 5.2. Description of the quality factors determined by the factor analysis that are used to characterize the quality of prescription drug advertisements and predict prescription rates.

Quality Factors that Characterize the Quality of DTCA

Medical Journal Expenditure (In Thousands) Office Detailing Expenditure (In Thousands) DTCA Expenditure (In Thousands) Benefit and Risk: Text Block Design

Characterizes the justification and width of the text block, as well as the spacing between it other ad features

Benefit and Risk: Headlines:

Characterizes the affect of headlines in capturing attention, segmenting text, and providing good information

Benefit and Risk: Font Style

Characterizes the font style, size, and darkness

Benefit and Risk: Font Spacing

Characterizes the spacing between letters and between lines

Benefit and Risk: Color Scheme

Characterizes the contrast between the colors of the text and the background, as well as the distractive nature of the image in attending to the text

Benefit and Risk: Reading Level

Characterizes the Flesch-Kincaid reading level and the percentage of passive voice used in the text

Tagline Characterizes whether raters believe the tagline relates to the ad content and whether the message is not misleading

Benefit Relates Characterizes whether the image and the tagline relate to the advertised medication and whether these are misleading

Rater Benefit Info Characterizes whether the image pertains to the advertised medication and the raters preference for the order of information

Compare Presentation

Characterizes the degree to which the location and framing of the benefit and risk information is similar

Indication Characterizes the effective length and supportive behaviors that are required by the FDA

Success Rate Characterizes whether ad mentions the success rate Scientific Characterizes the mechanism of action and other beneficial

effects of the advertised medication Risk Factors Characterizes the genetic and behavioral risk factors for the

condition mentioned in the ad, as well as the symptoms Behaviors Characterizes the behavioral risk factors and supportive behaviors

one should practice when taking the advertised drug Common Side Effects

Characterizes whether the ad mentions the drug’s common side effects

Placebo Characterizes whether the ad compares the rate of side effects for the drug to that of placebo

Risk Headline Characterizes the language in the risk headline (Please see discussion in content grading guidelines.)

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5.6. Advertising Quality and Prescription Rates

An ordinary least squares regression for total prescriptions was performed on all the

quality factors determined by the factor analysis. The quality factors alone seem to explain a lot

of the fluctuation in prescriptions (R-squared = 0.98). The regression was repeated for new

prescriptions(R-squared = 0.96), which fluctuate the most, and re-fill prescriptions (R-squared =

0.98). Table A5.4 contains the coefficients for the quality factors in each of these regressions.

Another set of tests was performed regressing the different types of prescription rates

(new, refill, total) on total advertising expenditures (DTCA +office detailing + medical journals).

Figures 5.8, A5.9-A5.10 depict the observed new, refill, and total prescription rates, as well as

those predicted by the regression on ad quality and the regression on ad expenditures, for Lipitor.

Total prescriptions and corresponding predicted prescription rates for the other drugs are also

shown in figures A5.11-A5.14. The flat lines indicate the predicted number of prescriptions

according to quality factors alone. Since the same ad campaigns generally run for 10 to 12

months, the number of prescriptions predicted remains constant during each campaign. The

actual and predicted values match well for new prescriptions and refill prescriptions of all the

other drugs, but are not depicted for sake of space and redundancy.

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Prescriptions Dispensed for Lipitor, Jan 1999 - Sept 2004

Figure 5.8. Prescriptions dispensed each month for Lipitor, along with the number of prescriptions predicted by DTCA quality factors and predicted by all advertising expenditures.

In general the coefficients from the regression on advertising quality suggest that an ad

must be visually appealing in order for it to affect prescriptions positively. Advertisements that

earned higher ratings for font spacing corresponded to higher prescription rates for the advertised

drug. In fact, advertisements at the 75th percentile in the risk font spacing category corresponded

to 1010 thousand more new prescriptions of the drug than advertisements with scores at the 25th

percentile. Similarly, the difference in prescriptions for advertisements at the 75th percentile

versus the 25th percentile in benefit font spacing corresponded to 454 thousand more new

prescriptions. Henceforth, we will call the change in prescriptions that corresponds to the

difference in advertisements at the 75th percentile and 25 percentile for a given quality factor the

prescription percentile difference. (Table A5.5) In no way does this relationship suggest that a

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change in the quality factor causes the change in prescriptions, we merely show that a correlation

appears to exist between prescriptions and quality factors.

Besides the font spacing, several other categories contribute to the visual appeal of the

advertisement. These include the text block design, font, and comparative presentation.

Prescription rates rise with a more highly regarded text block design for the risk information.

Surprisingly, new prescriptions fall for more highly rated benefit text block design (-567

thousand prescription percentile difference). This may occur because a more highly rated benefit

text block may require more space, using larger portion of the advertisement and perhaps

replacing appealing images. In this vain, new prescription rates fall with increasing scores for the

benefit and risk font (-541 and -469 thousand prescription percentile difference, respectively).

Again, more highly regarded fonts are generally larger in size, which may minimize the

appearance of an appealing image. Overall, it seems the visual appeal and spacing of the various

elements within the advertisements corresponds to higher new prescription rates. Advertisements

with similar location of risk and benefit information (196 thousand prescription percentile

difference for Compare Presentation), highly rated font spacing, and well designed risk text

blocks correspond to higher new prescriptions.

Beyond the visual appeal of the advertisement, the quality of the tagline and image seem

to correspond to new prescriptions. Advertisements with highly rated taglines correspond to an

increase in new prescriptions (96 thousand prescription percentile difference). Similarly,

advertisements with highly regarded benefit information from the rater’s perspective correspond

to an increase in new prescriptions (86 thousand prescription percentile difference).

Not surprisingly, increased scores for categories that highlight risk information

correspond to fewer new prescriptions. Advertisements that received high scores for its risk

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headline corresponded to fewer new prescriptions (-553 thousand prescription percentile

difference). A similar trend can be seen for the risk color category, especially for refill

prescriptions. Interestingly, a lower risk reading level corresponded to an increase in new

prescriptions. This may suggest that patients do not pursue drugs if they cannot understand the

risk information because of complicated language (-737 thousand prescription percentile

difference).

The content of an advertisement appears to have little correlation with new prescription

rates. There appears to be a correspondence, however, with refill prescription rates. Refill

prescription rates correspond to an increase in the information on indication and the scientific

nature of the drug (7215 and 492 thousand prescription percentile difference, respectively). This

suggests a correlation between prescription rates and information about the effective length of

the medication and mechanism of action for patients who already have some experience with the

advertised drug. Prescription rates for these experienced patients decline with a corresponding

increase in the information about risk factors and behaviors contained in the advertisement (-93

and -1836 thousand prescription percentile difference, respectively). This result reflects Roth’s

hypothesis that patients do not want DTC advertisements to remind them about their symptoms

and the behaviors that may have caused their condition. Patients, may, however, be interested in

the most common side effects associated with the advertised medication. Refill prescription rates

rose with a corresponding increase in the inclusion of information about common side effects

(1267 thousand prescription percentile difference). Likely those who are taking a drug are most

concerned about the side effects they are experiencing. Not surprisingly, there is a corresponding

negative relationship between side effect information and new prescriptions, although this is not

statistically significant.

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In general, visually attractive advertisements correspond to higher new and refill

prescription rates. The content of the tagline also seems to correspond with an increase in both

types of prescriptions. Surprisingly, the informational content of an advertisement only

corresponds to changes in refill prescriptions. This could possibly suggest a model for how

readers process DTC advertisements. If the ad is visually appealing, readers may dedicate more

time to reading the tagline. If the reader believes the tagline or image indicate that the drug may

relate to them personally, they may read more about the drug. The increasing involvement with

the advertisement may correspond to higher prescription rates.

5.7 Effective Advertising Expenditure

Figures 5.8, A5.9-A5.14 depict a significant correlation between the quality of a

prescription drug advertisement and prescription rates, with little correlation between

prescription rates and advertising expenditures alone. This result is somewhat difficult to

understand, because one would expect prescription rates to increase proportionally with the

number of people who saw the high quality advertisement. Therefore, we introduce the concept

of the effective advertising expenditure (EAE) to explain how DTCA expenditures affect

prescription rates, despite the low direct correlation:

Effective Advertising Expenditure = DTCA Expenditure / QF

where the QF refers to the predicted number of prescriptions based on the coefficients of the

regression on quality factors. (QF corresponds to either equation (1), (2), or (3) in table A5.4,

depending on the type of advertising per prescription cost one wishes to generate.) This

relationship suggests that the impact of advertising on prescriptions depends on both the quality

of the advertisement and the pervasiveness of the advertising. According to this theory, a low

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budget campaign for “high quality” ads and a high budget campaign for “low quality” ads would

have the same impact on prescription rates. (In this section we assume quality to be a property

that corresponds to higher prescription rates, not necessarily the most beneficial advertisements

from a public health perspective.) To test this theory, we graphed effective advertising

expenditure over time versus the advertising cost per prescription (ad expenditures/ prescription).

(Figure 5.15, A5.16 – A5.21)

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DTCA Expenditure Per Prescription Effective Advertising ExpenditureDTCA Expenditure Per Average Lipitor QF

Effective Advertising Expenditures and DTCA Expenditures Per Prescription for Lipitor

Figure 5.15. Advertising cost per new prescription for Lipitor and effective advertising expenditures (advertising expenditure per quality factors) for new prescriptions. A log scale is used to show the wide range of data.

The effective advertising spending has a remarkable ability to predict the advertising cost

per expenditure for every drug we studied. Again, we show this relationship for new, refill, and

total prescription for Lipitor, but only total prescriptions for all the other drugs.

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The effective advertising expenditure explains the discrepancies between the prescription

rates and the prescription rates predicted solely by advertising outlays. Figure A5.12 shows that

the observed prescription rates for Pravachol are much lower than predicted by the advertising

outlays, while figure 5.8 demonstrates that observed prescriptions for Lipitor are much higher

than expected by their advertising outlays alone. This should not be surprising, however, given

that the QF for the Pravachol advertisements ranged from 300 to 340, while the QF for the

Lipitor advertisements ranged from 920 to 1345. Prescription rates for Lipitor were much higher

than expected solely by their advertising outlays, because they showed “higher quality”

advertisements. The “low quality” ratings for the Pravachol ads correspond to the unexpectedly

low prescription rates compared to their advertising outlay. The effective advertising expenditure

model accurately explains these discrepancies.

5.8 Advertising Quality and DTC Expenditures

DTCA expenditures were regressed on all the ad quality characteristics to determine

whether companies spend more to promote “high quality” advertisements. There appears to be

no significant correlation between ad quality and DTCA outlays, suggesting that companies

produce and promote DTC advertisements with a wide range in quality. Our analysis suggests

that companies could achieve the same number of prescriptions using less advertising or generate

more prescriptions for advertised medications by investing and promoting higher quality

advertisements.

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6. Discussion

The DTC Assessment created to measure the quality of prescription drug advertisements

serves as a powerful tool to measure the public’s perception of DTC advertising. From the

content and presentation criteria the raters used to judge the DTC advertisements, a factor

analysis revealed many instrumental quality factors that can be used to characterize the quality of

a prescription drug advertisement.

Several of these quality factors highly correlate with prescription rates. In general, a

positive correlation exists between prescription rates and advertisements that are visually

appealing and contain pertinent taglines. Refill prescriptions also positively correlate with

information about the indication and side effects of the drug, but refill prescription rates fall with

information about the risk factors and behaviors associated with the disease. The inclusion of

quantitative benefit information did not significantly correlate with either new or refill

prescriptions. Overall the presentation of the advertisement and perception of benefit information

best explain the correlation between advertising quality and prescription rates.

Together the advertising quality factors and DTCA expenditures explain the fluctuation

in prescription rates. The effective advertising expenditure, or the expenditure per advertisement

quality, accurately predicts the advertising cost per prescription.

There were limitations to our study. First, the advertisements were viewed in a binder,

not in the context of a magazine. We were only able to rate the quality of magazine

advertisements and assumed that the quality of television and radio advertisements are equal to

the quality of the print advertisement. We also were not able to measure the effects of the news

media or internet exposure on consumers or the quality of advertisement to physicians. Finally,

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the age of all the raters in this study varied from 18-22. Given that many of the consumers of

these drugs are older, this study should be repeated with raters from representative groups.

Despite all these limitations, the effective advertising expenditure (EAE) can accurately

predict the advertising cost per prescription. Further work should be done to extend this analysis

to other drug classes. We expect that the EAE with a scale factor for the size of the drug class

will predict the advertising cost per prescription for other drugs with similar accuracy.

The results of this study can be very useful to drug companies in creating higher quality

advertisements, but may also be somewhat troubling to proponents of DTCA. They suggest that

DTCA is useful in motivating patients who learn about the symptoms and risk factors for under-

diagnosed conditions to seek medical attention. However, our analysis reveals that the

informational content of DTC advertisements is only significant for patients who have already

been treated. According to our analysis, new prescriptions correlate with the tagline and

perception of benefit information according to our analysis, but none of the information content

factors. This confirms Roth’s claim (1996) that consumers have a high awareness for ads that

contain transformational messages, but contain little concrete evidence about the true benefits of

the drug. Since several studies have shown that physicians tend to accede to many DTC requests,

both those that are appropriate and those at the margin of clinical benefit, it is important for the

advertisements to generate realistic expectations about the drug. More realistic expectations may

be generated by requiring advertisements to contain quantitative benefit information. However,

our study shows that including more benefit information may produce a tradeoff between

managing expectations and the power of the advertisement to correlate with higher prescription

rates. Advertisements that contained highly rated benefit text blocks correlated with fewer

prescriptions, which we believe occurs because the benefit information takes the place of the

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visually appealing images. Therefore, regulators must weigh the cost of the harm caused by

patients with unrealistic expectations requesting and receiving inappropriate advertised drugs

against the benefits of motivating people with under-diagnosed conditions to seek medical

attention.

The FDA may also use these quality factors to create regulations that generate the most

socially optimal forms of DTC advertising. Likewise, drug companies can earn a higher rate of

return on their advertising expenditures by creating advertisements that emphasize the quality

factors described, which may increase profits and help to target diseases that are under-

diagnosed.

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7. Appendix Table A4.1. Consumers’ Preferred Characteristics for DTC Advertisements

Table A4.1. Consumers’ preferences in DTC advertisements. Taken from “Focus Groups on Prescription Drug Printed Ads,” a study sponsored by the FDA and carried out by ORC Macro.

Format: Based on the respondents’ comments and reactions to current magazine ads, proposed prototypes, and participants’ proposals for an “ideal ad” the desirable format could be depicted by the following characteristics:

1) Legible text 2) Decent font size 3) Important information highlighted so it is not difficult to find different topics 4) Distinct headings standing out from the rests of the text 5) Visible name of a drug standing out at the top of a page 6) Bolded text for headings or other most important information 7) Text broken into paragraphs 8) White space between paragraphs 9) Bullet points for listings, such as list of ingredients or side effects 10) Text broken in columns 11) Objects such as text placed in frames or tables to break up a lengthy block of text

Content: Respondents’ opinions about a content of the brief summary of a prescription ad focused on the following topics that they believe should be included in such an ad:

1) Clear statement of what medical condition the advertised drug will treat and who is the drug for (adults/children/both; men/women/both)

2) Both positive and negative information about the drug 3) The performance of a drug and desired positive effects/benefits 4) Information on side effects 5) Information on drug interactions with other medications or substances 6) Information on health condition(s) that would not allow for taking a drug 7) List of ingredients (active and inactive ingredients necessary) 8) 800 number and website 9) Date of last update of information in ad

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Figure A4.1. A print advertisement for Levitra. Notice all the risk information is located to the left of the advertisement and actually separated by a line. The paragraph width and smaller font makes it difficult to read this information.

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DTC Assessment: Average Scores and Agreeability Between Raters Benefit Risk Difference

Category Average

Score AgreeabilityAverage

Score Agreeability Benefit –

Risk Score Overall AdDesign 0.66 0.87 N/A N/A N/A Overall Framing 0.72 0.85 N/A N/A N/A Overall Location 0.62 0.83 N/A N/A N/A Image Image 0.36 0.81 N/A N/A N/A Tagline Tagline 0.67 0.80 N/A N/A N/A

Headings Stand Apart 0.80 0.82 0.69 0.81 0.11

Headings Good Info 0.65 0.76 0.46 0.62 0.19

Headings Relate to Text 0.73 0.78 0.61 0.71 0.12

Headings Good Ratio 0.65 0.76 0.47 0.66 0.18

Font Font 0.84 0.85 0.80 0.81 0.04 Font Dark 0.87 0.87 0.84 0.84 0.03 Font

Letter Space 0.93 0.93 0.85 0.85 0.08

Font Line Space 0.90 0.90 0.76 0.79 0.14

Font Size 0.67 0.87 0.63 0.87 0.04 Color Color 0.89 0.85 0.83 0.86 0.06 Color Contrast 0.78 N/A 0.77 N/A 0.01 Color Distraction 0.76 N/A 0.72 N/A 0.04 Text Block Spacing 0.81 0.94 0.75 0.90 0.07 Text Block Width 0.84 0.85 0.68 0.72 0.16 Text Block Justified 0.67 0.91 0.40 0.73 0.27 Content Order 0.91 N/A 0.72 N/A 0.19 Headings Bullets 0.33 N/A 0.00 N/A 0.33 Reading Level 8.70 N/A 11.80 N/A -3.10 Voice Passive 0.04 N/A 0.18 N/A -0.14

Table A5.1. Average scores for the presentation categories in the DTC Assessment for all 34 advertisements rated and the agreeability between raters for each category.

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Factor Analysis: Benefit Quality Factors that Determine the Quality of a DTC Advertisement

Compare

Presentation Headline Font

Spacing Font Text

Block

Colors Reading

Level Benefit Relate Tagline

Rater Info

Eigen Value 1.49 3.56 2.17 0.34 0.491 0.46 1.185 0.3203 0.3203 Framing 0.8235 Location 0.8235 Stand Apart 0.9199 Good Info 0.9204 Relate to Text 0.974 Good Ratio 0.9128 Bullets 0.2928 Font 0.567 0.5447 Font Dark 0.3078 0.6785 Letter Spacing 0.6626 0.2157 Line Spacing 0.6418 0.2526 Font Size 0.1578 0.6418 Spacing 0.6382 Text Block Width 0.7999 Justification 0.5334 Color 0.3301 Contrast 0.04297 Distract 0.4442 Reading Level 0.8636 Passive Voice 0.8636 Image: Misleading 0.0994 -0.1276 -0.1276 Banner: Misleading 0.6163 0.2994 0.2994 Image -0.5193 -0.0398 -0.0398 Banner 0.2542 0.5861 0.5861 Order -0.1056 -0.2529 -0.2529

Table A5.3. Weightings of DTC Assessment criteria that characterize the benefit information within a DTC advertisement. Values obtained from a factor analysis using the principal factors method.

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Table A5.3. Weightings of DTC Assessment criteria that characterize the risk information within a DTC advertisement. Values obtained from a factor analysis using the principal factors method.

Factor Analysis: Content Quality Factors that Determine the Quality of a DTC Advertisement Indication Success Rate Scientific RiskFactors Behavior Eigen Value 1.207 - 0.87698 1.549 0.706 Required Behaviors 1.207 Effective Length -0.21711 Success Rate 1 Other Good Effects 0.3688 Long Term -0.441 mechanism 0.5713 Symptoms 0.0537 -0.4243 Risk Factors - Behavior 0.7147 0.5593 Risk Factors - Genetic 0.8158 -0.0482 Supportive Behaviors 0.1044 0.7554

Table A5.3. Weightings of DTC Assessment criteria that characterize the content within a DTC advertisement. Values obtained from a factor analysis using the principal factors method.

Factor Analysis: Risk Quality Factors that Determine the Quality of a DTC Advertisement

Headline Font Font

Spacing Text Block Colors Reading

Level Eigen Value 2.96 2.91 0.33 0.66474 1.769 0.826 Headlines: Stand Apart 0.8151 Headlines: Good Info 0.9171 Headlines: Relate to Text 0.9104 Headlines: Good Ratio 0.7938 Headlines: Bullets N/A Font 0.6738 0.417 Font Dark 0.7748 0.3538 Letter Spacing 0.363 0.7626 Line Spacing 0.3231 0.7524 Font Size 0.6243 0.3399 Spacing 0.581 Text Block Width 0.5531 Justification -0.1461 Color 0.8953 Contrast 0.9421 Distract 0.283 Reading Level -0.6428 Passive Voice 0.6428

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Predicted Difference in Prescription Rates: Results from an OLS Regression Quality Factors

New Prescriptions (1)

Refill Prescriptions (2)

Total Prescriptions (3)

Benefit Headlines

55.18894 (87.12295)

621.5983** (182.0906)

723.6093** (235.7019)

Benefit Font

-834.012** (218.5619)

-2032.403** (456.8035)

-2983.42** (591.2961)

Benefit Font Spacing

519.8475** (146.5092)

1809.5** (306.2102)

2432.381** (396.3649)

Benefit Text Block Design

-431.405** (135.308)

-1375.384** (282.7994)

-1902.8** (366.0615)

Benefit Reading Level

130.0693 (112.9318)

468.847* (236.032)

610.048* (305.5249)

Risk Headlines

-693.145** (207.3879)

-2571.266** (433.4493)

-3412.87** (561.066)

Risk Font

-588.556** (175.0656)

-1962.726** (365.8943)

-2692.98** (473.6213)

Risk Font Spacing

727.2739** (131.0172)

1912.122** (273.8313)

2698.683** (354.453)

Risk Text Block Design

242.6519 (195.4179)

1794.777** (408.4316)

2196.277** (528.6825)

Risk Colors

-18.3486 (220.6546)

-1623.516** (461.1773)

-1779.23** (596.9577)

Risk Reading Level

-706.019* (308.1584)

-2652.259** (644.0637)

-3549.66** (833.6897)

Compare Presentation

181.2273** (40.198)

998.4006** (84.01548)

1241.16** (108.7514)

Tagline

200.1108* (79.74066)

1485.976** (166.6613)

1743.925** (215.7299)

Benefit Relate

255.7893** (60.42264)

-737.7326** (126.2858)

-531.949** (163.467)

Success Rate

-275.276 (204.4642)

-334.9262 (427.3386)

-694.286 (553.1561)

Indication

570.397 (361.35)

3489.481** (755.2364)

4265.227** (977.5939)

Scientific

77.35209 (100.9388)

608.336** (210.9662)

731.5486** (273.0791)

Risk Factors

48.6334 (43.90657)

-235.2158* (91.76654)

-237.355* (118.7846)

Behavior

-399.852 (206.574)

-1043.408* (431.7481)

-1487.18** (558.8639)

Common Side Effects

-312.415 (248.3162)

1631.083** (518.991)

1512.057* (671.793)

R-squared 0.9554 0.9753 0.9757 Table A5.4. Predicted changes in prescription rates based on an OLS regression on DTCA quality factors. Note predictions are made for new prescriptions in (1), refill prescriptions in (2), and total prescriptions in (3). Standard Errors are reported in parentheses. * indicates the change is significant at the 5% level, and ** indicates the changes is significant at the 1% level.

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Prescription Percentile Difference for Quality Factors Quality Factors

Change in New Prescriptions

Change in Refill Prescriptions

Change in Total Prescriptions

Benefit Headlines 112.51 1267.18 1475.14 Benefit Font -540.90 -1318.11 -1934.89 Benefit Font Spacing 454.42 1581.74 2126.22 Benefit Text Block Design -567.28 -1808.58 -2502.11 Benefit Reading Level 80.99 291.95 379.87 Risk Headlines -553.14 -2051.89 -2723.49 Risk Font -469.34 -1565.15 -2147.48 Risk Font Spacing 1009.73 2654.75 3746.79 Risk Text Block Design 281.29 2080.59 2546.03 Risk Colors -31.77 -2811.01 -3080.62 Risk Reading Level -737.32 -2769.84 -3707.03 Compare Presentation 194.89 1073.67 1334.72 Tagline 95.93 712.33 835.98 Benefit Relate 86.42 -249.25 -179.72 Success Rate -275.28 -334.93 -694.29 Indication 1179.45 7215.43 8819.49 Scientific 62.62 492.48 592.22 Risk Factors 19.26 -93.13 -93.97 Behavior -703.40 -1835.51 -2616.16 Common Side Effects -156.21 815.54 756.03 Table A5.5. Expected difference in prescriptions between an advertisement that is rated at the 75th percentile and an advertisement at the 25th percentile for a given category, holding all other category scores equal.

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Figure A5.9. New prescriptions dispensed each month for Lipitor, along with the number of new prescriptions predicted by DTCA quality factors and predicted by all advertising expenditures.

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Refill Prescriptions Dispensed Predicted By Ad QualityPredicted By Ad Expenditures

Refill Prescriptions Dispensed for Lipitor, Jan 1999 - Sept 2004

Figure A5.10. Refill prescriptions dispensed each month for Lipitor, along with the number of prescriptions refills predicted by DTCA quality factors and predicted by all advertising expenditures.

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Prescriptions Dispensed for Zocor, Jan 1999 - Sept 2004

Figure A5.11. Prescriptions dispensed each month for Zocor, along with the number of prescriptions predicted by DTCA quality factors and predicted by all advertising expenditures.

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Prescriptions Dispensed Predicted By Ad QualityPredicted By Ad Expenditures

Prescriptions Dispensed for Pravachol, Jan 1999 - Sept 2004

Figure A5.12. Prescriptions dispensed each month for Pravachol, along with the number of prescriptions predicted by DTCA quality factors and predicted by all advertising expenditures.

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Prescriptions Dispensed Predicted By Ad QualityPredicted By Ad Expenditures

Prescriptions Dispensed for Vioxx, Jan 1999 - Sept 2004

Figure A5.13. Prescriptions dispensed each month for Vioxx, along with the number of prescriptions predicted by DTCA quality factors and predicted by all advertising expenditures.

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Prescriptions Dispensed Predicted By Ad QualityPredicted By Ad Expenditures

Prescriptions Dispensed for Celebrex, Jan 1999 - Sept 2004

Figure A5.14. Prescriptions dispensed each month for Celebrex, along with the number of prescriptions predicted by DTCA quality factors and predicted by all advertising expenditures

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DTCA Expenditure Per New Prescription Effective Advertising Expenditure

Effective Advertising Expenditures and DTCA Expenditures Per New Prescription for Lipitor

Figure A5.16. Advertising cost per new prescription for Lipitor and effective advertising expenditures (advertising expenditure per quality factors) for new prescriptions.

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Exp

endi

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DTCA Expenditure Per Refill Prescription Effective Advertising Expenditure

Effective Advertising Expenditures and DTCA Expenditures Per Refill Prescription for Lipitor

Figure A5.17. Advertising cost per refill prescription for Lipitor and effective advertising expenditures (advertising expenditure per quality factors) for refill prescriptions.

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DTCA Expenditure Per Prescription Effective Advertising Expenditure

Effective Advertising Expenditures and DTCA Expenditures Per Prescription for Zocor

Figure A5.18. Advertising cost per prescription for Zocor and effective advertising expenditures (advertising expenditure per quality factors) for total prescriptions.

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DTCA Expenditure Per Prescription Effective Advertising Expenditure

Effective Advertising Expenditures and DTCA Expenditures Per Prescription for Pravachol

Figure A5.19. Advertising cost per prescription for Pravachol and effective advertising expenditures (advertising expenditure per quality factors) for total prescriptions.

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.51

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DTCA Expenditure Per Prescription Effective Advertising Expenditure

Effective Advertising Expenditures and DTCA Expenditures Per Prescription for Vioxx

Figure A5.20. Advertising cost per prescription for Vioxx and effective advertising expenditures (advertising expenditure per quality factors) for total prescriptions.

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DTCA Expenditure Per Prescription Effective Advertising Expenditure

Effective Advertising Expenditures and DTCA Expenditures Per Prescription for Celebrex

Figure A5.21. Advertising cost per prescription for Celebrex and effective advertising expenditures (advertising

expenditure per quality factors) for total prescriptions.

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