Direct‐to‐Consumer Drug Advertisements and the Informed Patient: A Legal, Ethical, and Content Analysis

• Date: 01 December 2013
• DOI: http://doi.org/10.1111/ablj.12019
• Author: Joshua E. Perry,Dena Cox,Anthony D. Cox
• Published date: 01 December 2013

Direct-to-Consumer Drug

Advertisements and the Informed

Patient: A Legal, Ethical, and

Content Analysis

Joshua E. Perry,* Anthony D. Cox,** and Dena Cox***

INTRODUCTION

The ultimate goal of most advertising is to increase product sales.1

However, much advertising does not exert an immediate impact on

*Assistant Professor of Business Law and Ethics, Life Sciences Research Fellow and Jesse Fine

Fellow in Practical Ethics, Kelley School of Business, Indiana University.Preliminary drafts of

this article were presented at the 2012 Huber Hurst Seminar, hosted by the Warrington

College of Business Administration’s Department of Management at the University of

Florida, and the 2012 Tri-State Academy of Legal Studies in Business Conference, hosted by

Central Michigan University. The authors are grateful for constructive feedback provided at

these meetings by Virginia Maurer, Robert Thomas, Robert Emerson, Dan Cahoy, David

Orozco, Amy Sepinwall, Karie Davis-Nozemack, Alex Reed, Mystica Alexander, Stuart

Pardau, and Ken Sanney. Additionally, our Kelley School colleagues in the Department of

Business Law and Ethics provided helpful comments to a preliminary draft presented during

a fall 2012 faculty research presentation. Finally,this article was strengthened in a number of

ways by the adroit editorial efforts of Robert Sprague. The authors are indebted to these

many generous colleagues.

**Professor of Marketing, Chancellor’s Faculty Fellow and Life Sciences Research Fellow,

Kelley School of Business, Indiana University.

***Professor of Consumer Research, Health Behavior Research Fellow and Life Sciences

Research Fellow, Kelley School of Business, Indiana University.

1C.L. TYAGI &ARUNKUMAR,ADVERTISING MANAGEMENT 278 (2004) (“It would not be out of place

to stress that the main purpose of advertising is to increase sales.”). All advertising is intended

to sell a product. In fact, successful marketing campaigns are often aimed at convincing

consumers that their lives will be improved if they buy what is being sold. Generally speaking,

informing the end-use consumer about product details is, from the perspective of the

manufacturer,only necessary to the e xtent this information can be used to trigger a desire on

the part of the consumer to purchase the product. DAVID OGILVY,OGILVY ON ADVERTISING 24

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consumer purchase behavior, but rather elicits intermediate consumer

responses such as increased brand awareness, interest, and information

seeking.2

In the case of direct-to-consumer (DTC) advertising of prescription

drugs, the link between advertising exposure and purchase is often espe-

cially circuitous, in part because consumers cannot simply go out and

freely purchase the advertised product. Instead, consumers must first

consult with a health-care provider,3who then decides whether to pre-

scribe the advertised product, an alternative treatment, or nothing at all.

Thus, DTC advertising seeks to educate and ultimately motivate consum-

ers to initiate discussions with their physicians, with the hope that some of

these discussions will lead to the purchase of the advertised product.4

(1985) (quoting legendary advertising executive Rosser Reeves: “Let’s say you are a

manufacturer....[W]hat do you want out of me? Fine writing? Do you want masterpieces?

Do you want glowing things that can be framed by copywriters? Or do you want to see the

goddamned sales curve stop moving down and start moving up?”). Of course, the law also mandates

that adequate warnings accompany products and proper instructions for use be included so

that the foreseeable, end-use consumer can avoid harm and make a fully informed decision

regarding purchase and use. In fact, products liability law generally considers a product to be

defective if “the foreseeable risks of harm posed by the product could have been reduced or

avoided by the provision of reasonable instructions or warnings by the seller or other

distributor.” RESTATEMENT (THIRD)OF TORTS:PRODUCTS LIABILITY § 2(c) (1998); cf. infra note 58

(discussing RESTATEMENT(SECOND)OF TORTS § 402(A) cmt. k (1965) (noting that an unavoidably

unsafe product, such as a drug, can be rendered not defective by proper directions and

warnings)); see also Karl A. Boedecker et al., Excessive Consumption: Marketing and Legal Per-

spectives,36A

M.BUS. L.J. 301, 324 (1999) (noting that for products that are unavoidably

unsafe, including pharmaceuticals, warnings must be adequate in terms of both semantics

and physical presentation).

2Cf. Robert J. Lavidge & Gary A. Steiner, A Model for Predictive Measurements of Advertising

Effectiveness,25J.M

ARKETING 59, 62 (1961) (discussing measurements of advertising effective-

ness through the steps of the “purchase flight,” including brand awareness).

3While the prescribing health-care provider will often be a physician, others with the power

to prescribe include physician’s assistants, nurse practitioners, and dentists.

4Hank McKinnell, former Chairman of the Board and CEO of Pfizer, Inc. argues,

DTC advertising can be a powerful public good—making people familiar with various

therapies and promoting the primacy of the doctor-patient relationship. Good DTC

communication should encourage people to talk with their physicians about their

medical conditions. DTC advertising should help demystify sensitive medical problems

and encourage people to seek treatment even for conditions stigmatized by society. For

all these reasons, I prefer to describe our efforts as DTC education.

HANK MCKINNELL,ACALL TO ACTION:TAKING BACK HEALTHCARE FOR FUTURE GENERATIONS

179–80 (2005); see Elyse Krezmien et al., The Role of Direct-to Consumer Pharmaceutical Adver-

tisements and Individual Differencesin Getting People to Talkto Physicians,16J.H

EALTH COMM. 831,

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Some DTC advertisements are intended to build “selective

demand”—in others words, consumer preference for a specific drug

brand. However, DTC advertisements often work by building “primary

demand” for an entire product category. An entire advertising campaign

might be built around the goal of increasing consumers’ recognition that

they might suffer from a medical condition—for example, social anxiety

disorder or low testosterone—or increasing consumers’ awareness that

there are treatments available for their condition. In fact, some DTC

advertisements—known as “help-seeking ads”—do not mention a brand

name at all, but merely prompt consumers to “ask their doctor” about

new—unnamed—treatments for the malady in question. Such “help-

seeking” advertisements, unlike branded DTC advertisements touting par-

ticular products, are not regulated by the Food and Drug Administration

(FDA).5Regardless of the advertising format, “[d]irect-to-consumer adver-

tising leads to more drug information for patients.”6The challenge, as

Marshall Chin notes, is ensuring that patients encounter accurate and

833 (2011) (discussing measurements of effective health messages which lead to the desired

outcome of the patient discussing the product with her doctor). As Marcia Angell, former

editor of the New England Journal of Medicine, notes, “[t]here is overwhelming evidence that

the ads work. People go to their doctors and ask for the new drugs, and very often get them.”

MARCIA ANGELL,THE TRUTH ABOUT THE DRUG COMPANIES:HOW THEY DECEIVE US AND WHAT TO

DOABOUT IT124 (2004) (citing MEREDITH B. ROSENTHAL ET AL., DEMAND EFFECTS

OF RECENT CHANGES IN PRESCRIPTION DRUG PROMOTION (2003), available at http://www.

kff.org/rxdrugs/upload/Demand-Effects-of-Recent-Changes-in-Prescription-Drug-Promotion

-Report.pdf; Meredith B. Rosenthal et al., Promotion of Prescription Drugs to Consumers, 346

NEW ENG.J.MED.498 (2002); Robert Pear, Investigators Find Repeated Deception in Ads for Drugs,

N.Y. TIMES, Dec. 4, 2002, at A22; Vanessa Fuhrmans & Gautam Naik, In Europe, Prescription-

Drug Ads Are Banned—And Health Costs Lower,W

ALL ST. J., Mar. 15, 2002, at B1).

5Denis G. Arnold, The Ethics of Direct-to-Consumer Pharmaceutical Advertising,in ETHICS AND THE

BUSINESS OF BIOMEDICINE 131, 133 (Denis G. Arnold ed., 2009); see also John E. Calfee, Public

Policy Issues in Direct-to-Consumer Advertising of PrescriptionDrugs,21J.P

UB.POL’Y&MARKETING

174, 174 (2002) (“ ‘Help-seeking’ advertisements could discuss that a treatment existed for a

condition, but they could neither mention a drug by name nor make suggestions and

representations about drug treatments.”).

6Marshall H. Chin, The Patient’s Role in Choice of Medications: Direct-to-Consumer Advertising and

Patient Decision Aids,5YALE J. HEALTH POL’YL. & ETHICS 771, 775 (2005). However,“[c]urrent

regulatory and enforcement practices have been insufficient to prevent the dissemination of

some inaccurate or misleading advertisement.” Id. at 771. One benefit of DTC is increased

awareness among the lay public of new treatments. See Before the Subcomm. on Consumer Affairs,

Foreign Commerce, and Tourism, Senate Comm. on Sci. & Transp. (2001) (statement of Nancy M.

Ostrove, Ph.D., Deputy Director, Division of Drug Marketing, Advertising & Communica-

tions, Department of Health & Human Services), available at http://www.hhs.gov/asl/testify/

t010724.html (discussing potential benefits of DTC advertising).

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