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When Patients Influence Physicians:
Empowerment of Fine-Print Readers by Direct-To-Consumer Drug Advertising
and Implications to the Two-Step Flow Model
Submitted to the
AEJMC Convention
Advertising Division for Research
By
Annisa Lee
Ph.D. Student
School of Journalism and Mass Communication
University of North Carolina at Chapel Hill
-------------------
104 Nodding Oak
Chapel Hill, N.C. 27516-8980
Office (919) 843-5795
Home (919) 960-0808
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Abstract
When Patients Influence Physicians:
Empowerment of Fine-Print Readers by Direct-To-Consumer Drug Advertising
and Implications to the Two-Step Flow Model
"The Large Print Giveth, and the Small Print Taketh Away" is a common
expression to describe the deceptiveness and uselessness of product ads and
fine print in general. The situation is completely different in drug
ads. This paper will show that for drug ads, "The Large Print Giveth, and
the Small Print Giveth even more."
A survey of 1081 participants indicates that fine print reading of drug
ads affects changes in attitudinal and behavioral aspects in
patients. Attitudinal changes include making the patients think of a
question before going to see a doctor, raising patients' awareness of new
drug, giving them enough information to decide whether they should discuss
the drug with a doctor, helping patients make better decisions about their
health, and helping patients have better discussions with doctors about
their health.
Behavioral changes include helping the patients to look for more
information about the drug or health, look for further information by
talking to the doctor, ask the doctor about a medical condition or illness
that the patient has not talked to the doctor before, ask the doctor
whether there may be a prescription drug to treat his / her condition, ask
about a specific brand of prescription drug, and mention a drug ad or bring
some information about a drug with him / her to the doctor.
The fact that almost half of the doctors gave the prescription drugs
requested specifically by fine print readers has profound implication to
the two-step flow model: the traditional patient-followers have become new
opinion leaders with drug knowledge that influence their former
physician-opinion leaders. Advertising through the mass media is powerful
after all.
When Patients Influence Physicians:
Empowerment of Fine-Print Readers by Direct-To-Consumer Drug Advertising
And its Implications to the Two Step Flow Model
The Uselessness of Product Fine Print
For years, the use of fine print in advertising has received many
disparaging responses. "The large print giveth, and the small print taketh
away,"[1] became a common mentality for the public who constantly watched
out for traps embedded in tiny words.[2] Scholars argued that advertisers
had either no intention to communicate or had actually intended to mislead
the consumers by placing the fine print out of normal vicinity in the
ads.[3] Many believed that advertisers used the fine print on products as
a means to protect their own interests, presenting information they did not
want to tell the consumers in nearly illegible print.
More academic research efforts, including content analyses[4] and empirical
tests of communication effectiveness[5] continued to question the
effectiveness of fine print. Some concluded that consumers were unable to
read the messages anyway due to factors such as small print size, brevity
of appearance and incomprehensible language (especially for children). In
a more recent survey of 100 national advertisers, "a majority of
respondents representing leading advertisers, agencies, regulators, and
media firms agreed that consumers "do not," "cannot," and /or "do not
attempt to" read the fine print in ad."[6]
Despite prevailing alleged claims of ineffectiveness for the use of fine
print, government agencies still enforce the mandatory use of fine prints
in products such as cigarettes, alcohol; and disclaimers on television for
children programs regarding toy and food ads. The forced regulations of
the use of these disclaimers were subjected to controversial debate and
their effectiveness was tested with strenuous research. For instances, an
experiment testing the effectiveness and format effect of in-ad disclosure
of health warnings indicated that "disclosures failed to communicate the
health warning to nearly half of all subjects in spite of forced exposure
conditions."[7] Preliminary results of an eye-tracking experiment
indicated that in the beer ad, "the voluntary message encouraging
responsible drinking had limited warning value."[8] Regarding cigarette
warnings, even the Federal Trade Commission (FTC) staff report concluded
that warnings appearing on cigarette labels were "not effective".[9] The
FTC was particularly stringent in regulating children's television programs
and many studies concentrated on the use of disclaimers in ads during
children programming.[10] In an investigation of the use of the fine print
in children's television advertising, 552 TV ads were analyzed and "few of
these messages possessed characteristics that would be considered conducive
to effective communication."[11] Legal scholar Ivan Preston reasoned for
the FTC ruling that a qualification presented weakly had the same impact as
a qualification completely absent.[12]
Subsequently, the traditional uses of advertising fine print on products
such as beer or cigarettes, whether with or without forced legal enactment,
were perceived as quite ineffective. But what about the use of the fine
print in the relatively new trend of direct-to-consumer (DTC) prescription
drug ads? Not much scholarly research discussed the effectiveness and
functions of the fine print in direct-to-consumer prescription drug
ads. Are consumers reading the fine print in drug ads since drug can be a
product of high involvement? Who are the fine-print readers of
direct-to-consumer prescription drug ads? What are the benefits of reading
those fine prints? Will readers be empowered by new information, which
used to go to physicians first? These are some of the questions that this
paper will attempt to explore.
Drug Fine Print to Physicians
From 1938, with the passage of the Food, Drug and Cosmetic Act (the Act),
until the mid-1980s, the pharmaceutical industry focused its marketing
efforts almost entirely on physicians, also legally known as the "learned
intermediaries", who filtered the necessary information they read in the
fine print and ads to consumers.[13] The reasoning was that the use of
"medical products and drugs required medical sophistication beyond that
found among people without specific medical education and training,"[14]
and the learned intermediary doctrine relieved pharmaceutical companies
from product liability issues. There is research evidence to show that
physicians relied heavily on information provided by commercial literature
and their prescribing habits were strongly influenced by commercial than
scientific sources.[15] The physician would then review the patient's
condition, educate the patient and make the expert decisions about
diagnostic and therapeutic approaches for that patient.
During those communication processes, the physicians received information
from the mass media (step one) and became the identifiable "opinion
leaders" who shared the information with their patients or "followers" in
an interpersonal relationship setting (step two), thus conforming to the
classic top-down, two-step flow communication hypothesis proposed by the
Lazarsfeld study in 1944.[16] Will this model change when the mass
mediated drug ads are directed to consumers instead? Will the learned
consumers take the initiation to talk to the experts? And more importantly,
will the newly empowered followers influence the conventional opinion
leaders?
Drug Fine Print to Consumers
When the Food and Drug Administration (the FDA) issued a Federal Register
notice,[17] announcing the end of the moratorium imposed on prescription
drug advertising to consumers in on Sept. 9, 1985, pharmaceutical companies
were theoretically allowed to advertise drug ads directly to the
public. The movement started slowly due to skepticism from
physicians.[18] However, with the encouragement of success stories from
oral contraceptives (Lexis Pharmaceuticals),[19] Nicorette stop-smoking gum
(Lakeside Pharmaceuticals)[20] and Rogaine hair regrowth formula (Upjohn
Pharmaceuticals),[21] waves of direct-to-consumer drug campaigns began to
flourish, and "bypassing physicians and advertising prescription drugs
directly to consumers."[22]
To ensure public safety, the FDA derived one of its many obligations from
the FTC in the Wheeler Lea Act to regulate false and misleading
advertisement of prescription drugs.[23] In 1995, the FDA issued the first
draft guidance[24] under the Act to regulate direct-to-consumer drug
advertising. The draft guidance was finalized in 1997. Another draft
guidance designed particularly for consumer-directed broadcast ads was
issued in August, 2000 to supplement the Act. The Act requires that all
drug ads contain information in brief summary and adequate provisions
relating to side effects risk information, warnings, major precautions,
contraindications, and effectiveness of the drug. Drug ads must present a
fair balance between effectiveness and risk information and cannot be false
or misleading or omit material facts. A drug ad will be declared
'misbranded" if it fails to meet any of these requirements.[25]
The Act in 1997, allowing manufacturers who advertise prescription
medicines on television more flexibility in providing information about the
risks of the drugs, was believed to accelerate the increased use of DTC
advertising.[26] More than $2.5 billion was spent by the pharmaceutical
industry in 2000 alone to market prescription drugs to the general
public.[27] Medical scholar Jeffrey Razen commented that, "It is now
practically impossible for consumers to read a major newspaper or a
nationally circulated magazine, to watch television, or to listen to the
radio without coming across an advertisement from a medical product or
procedure."[28] As a result, patients' awareness of drug ads increased to
as high as 72% for certain drugs.[29] Whether such increase in knowledge
among consumers has a direct and tested relationship to the reading of the
fine print, i.e. the brief summary, is unknown.
Empowerment of Consumers and Pressure on Physicians
One thing is certain, though, that "during the past two decades, there has
been an irreversible change in the nature of the physician-patient
relationship. Patients are seeking much more medical information and are
actively participating in decisions affecting their health."[30] A 1999
survey conducted by Prevention magazine[31] found that since 1997, more
than 53 million consumers talked to their physicians about a medicine they
saw advertised and as many as 12.1 million consumers received a prescribed
drug as a direct result of seeing a DTC advertisement.
In a telephone poll conducted among 199 primary care doctors, 91% of them,
whose patients asked them about drugs they had seen advertised in the
media, felt under pressure to prescribe them. 30-36% in such cases, the
doctors gave in to the pressure, even when the drug in question was not
their first choice.[32]
Medical scholars were involved in ambivalent debates: some believed that
active patient inquiries of medical conditions and health treatments
strengthened the health care system and enlightened previously uninformed
patients;[33] others thought that such pressures eroded and threatened
physicians' rights. As one study indicated that as many as half of
patients would register disappointment, and 15% would consider switching
physicians, if their physician refused a request for an advertised
prescription medication.[34] The truth is, the one-sided, two-step
information flow model traditionally prescribed for physician-patient
relationship is forever altered.
The Two-step Flow Model
The original two-step proposal, constructed to explain an unexpected
failure of mass media effects, emphasized the power of primary groups and
interpersonal communications in relaying relevant information and
persuasion to the public. Information went from the mass media directly to
opinion leaders (step one), then from opinion leaders through interpersonal
communication to the rest of the public (step two). The model assumed
that opinion leaders made greater use of the media than those who were less
active, and opinion leaders influenced those who were less active more than
the reverse.[35] Figure one illustrates the mechanism:
Original Two-Step Hypothesis
(Figure One)
Further studies about news sources proposed the concept of "opinion
sharing" that frequent conversations were more prevalent among opinion
leaders themselves than between opinion leaders and followers.[36] The
Decatur field study affirmed the view that leader physicians influenced
their follower doctors who in turn influenced their expert leaders. [37]
That is, opinion leaders have their own opinion leaders. The study also
delineated the profile and attributes of influential opinion leaders who
were different from other people by their social positions or statuses or
their greater interest in the topic in discussion. The original concept of
"ideas" was too general and was replaced by two terms "information" and
"influence".[38] "Information" identifies the link between mass media and
opinion leaders, and "influence" as the link by which opinion leaders
structure the information to influence the followers. This revised
relationship is portrayed in figure two:[39]
Revised Step-Flow Sequences
(Figure Two)
Influence, not just information, usually goes from opinion givers to
opinion givers or opinion givers to opinion receivers, no matter who seeks
the advice first. In the lawn care field test, results indicated that
instead of initiating conversations, opinion leaders were often sought out
by followers who read the articles in the Bulletin.[40] Media information
flow bypassed the opinion leader and went directly to the audience members.
The new model predicted that followers who were exposed to media messages
that were inconsistent with their predispositions "would initiate the
second-step flow of communication and sought advice from opinion
leaders."[41] The followers received the advice and then made their own
decisions. Seldom did followers influence leaders, in accordance to a
principle mentioned by media scholar John Robertson:
Evidence for any substantial flow of information or influence in the
direction of the opinion receivers to the opinion givers would be anathema
to the entire model."[42]
The Application of Multi-Step Flow Model on Physicians
A group of investigations in the 70s' added new insights to the two-step
model (ideas such as opinion leaders relying on the mass media more than
others, information flow is actually information seeking, etc.[43]) but
this paper wanted to highlight an article that coined the term "multi-step
flow" [44] and was also a landmark[45] that discussed physicians'
communication model and adoption of new prescription drugs. According to
the study, "The diffusion of an Innovation Among Physicians", the channels
of influence conformed to the hypothesis that messages originating outside
of the individual's face-to-face group did not impinge on the doctor
directly, but were mediated by a few members of his group, who exposed
themselves to the messages from the outside world more than their
colleagues.[46] "Opinion leaders turned to colleagues of even higher
status, and that it might take three or four steps (hence, the multi-step
proposal), before a level of leadership was reached where dependence on
personal contacts was markedly decreased."[47] The sudden spurts of doctors
prescribing new drugs were also accounted for by social relations. Each
spurt represented the almost simultaneous adoption of the drug by a
socially close-knitted group of physicians. In its conclusion, the article
mentioned that:
The notion of the importance of interpersonal relations are applicable to a
case of decision-making among specialists concerning matters based on
scientific findings where well-recognized expert sources of knowledge
exist…. that the model may not apply to channels of low prestige and
unusually easy accessibility; and [the model should be amended by]
differentiating various kinds of leadership, especially by emphasizing the
differential roles of the innovator or pioneer on the one hand and the
opinion leader or arbiter on the other.[48]
In another word, the application of the two-step model to the "high
prestige", and "low accessibility" physicians' world was very specific:
that specialists consulted several higher levels of expert knowledge in
deciding whether or when to use the prescription drug. The influence came
from leadership of different types: pioneer, innovator, and arbiter, who
all had well-recognized expertise.
This paper will investigate if people of lower level of expertise will
influence the physicians.
Research Questions
This paper will address a few research questions:
1. How significant is the fine print readership in direct-to-consumer
prescription drug advertising?
2. Who are the fine print readers of direct-to-consumer prescription drug ads?
3. How does fine print readership of direct-to-consumer prescription drug
ads affect consumers / patients?
Methodology
In the spring of 1999, the Division of Drug Marketing, Advertising, and
Communications (DDMAC) of the FDA conducted a national telephone survey
entitled, "Attitudes and Behaviors Associated with Direct-to-Consumer
Promotion of Prescription Drugs". Interviewers called 1083 participants to
find out their views on DTC prescription drug advertising and its effects
on their visits to physicians. In order to find out more about the
physician-patient relationship, the FDA paid special attention to surveying
adults who visited a physician within three months of the interviews.[49]
Multiple regressions were used to analyze interval variables, crosstabs
were conducted to analyze nominal variables.
Results and Discussion
Research question 1: How significant is the fine print readership in
direct-to-consumer prescription drug advertising?
According to the data, 771 respondents out of 1081 recalled seeing or
hearing an ad for a prescription drug (Q.5) and out of these 771 responses,
two questions concerning the fine print was asked:
Q.11. Advertisements for prescription drugs in magazines and newspapers
usually have small print information that gives more details about the
drug. How much, if any, of the small print information would you say you
usually read?
Among the 771 respondents, 117 (15.2%) read all of the information, 77
(10%) read almost all of the information, 99 (12.8%) read about half of all
the information, 197 (25.6%) read only a little of the information and 265
(34.4%) read none or do not even notice there is information existing. The
result is tabulated in table one:
Frequency Table for Fine Print Readership for Drug Ads
Amount of fine print read
Frequency
Percent
Cumulative Percent
Read none or do not notice
265
34.4
34.4
Read a little
197
25.6
60
Read about half
99
12.8
72.8
Read almost all
77
10.0
82.8
Read all
117
15.2
98
Missing Values
16
2.0
100
Total
771
100.0
(Table One)
The level of the fine print readership is expected to rise when product
involvement is high. Hence, another question about the fine print
readership is analyzed:
Q.12. If you were especially interested in the advertised drug for some
reason, how much, if any, of the small print information would you read?
According to the frequency tabulation of the data, out of the 764
respondents (7 respondents who had never seen magazine / newspaper ads but
recalled ads in other formats were excluded for this question), who
recalled seeing or hearing about a drug ad in the past three months, 554
(72.5%) read all of the information, 96 (12.6%) read almost all of the
information, 60 (7.9%) read about half of the information, 25 (3.3%) read
only a little of the information, and 27 (3.5%) read none of the information.
The details are recorded in table two:
Frequency Table for the Fine Print Readership when Interested
[1] Flotron, J. (1995, April). The large print giveth, but the small print
taketh away! St. Louis Journalism Review, 24, 12.
[2] Bordwin, M. (1996, May). Six traps in the fine print. Management
Review, v85 n5, 54-56.
[3] Foxman, E., Muehling, D., & Moore, P. (1988). Disclaimer footnotes in
ads: discrepancies between purpose and performance. Journal of Public
Policy & Marketing, 7, 127-137.
[4] Kolbe, & Muehling, D. (1992), A content analysis of the "fine print"
in television advertising. Journal of Current Issues and Research in
Advertising, 14 (2), 47-61. See also: Atkin, C. & Heald, G. (1977). The
content of children's toy and food commercials. Journal of Communication,
27 (Winter), 107-114. See also: Hoy, M., & Stankey M. (1993). Structural
characteristics of televised advertising disclosures: a comparison with the
ftc. clear and conspicuous standard. Journal of Advertising, 22 (June),
47-58. And, Klebba, M., Stern, B., & Tseng, D. (1994). Disclaimers in
children's television advertising revisited: a decade makes a difference.
In Proceedings of the 1994 Conference of The American Academy of
Advertising, Karen Whitehill King, ed., Athens, GA: Henry W. Grady College
of Journalism and Mass Communication, University of Georgia, 50-57.
[5] Barlow, T. & Wogalter, M. (1993). Alcoholic beverage warnings in
magazine and television advertisements. Journal of Consumer Research, 20
(June), 147-156. See also: Best, A. (1989), The Talismanic use of
incomprehensible writings: an empirical and legal study of words displayed
in TV advertisements. St. Louis University Law Journal, 33 (Winter),
285-329. See also: Stutts, M. & Hunnicutt, G. (1987), Can young children
understand disclaimers in television commercials? Journal of Advertising,
16 (1), 41-46.
[6] Muehling, D., & Kolbe, R. (1997). Fine print in television
advertising: views from the top. Journal of Advertising, 26 (3), 1-15.
[7] Popper, E., & Murray, K. (1989). Communication effectiveness and
format effects on in-ad disclosure of health warnings. Journal of Public
Policy and Marketing, Vol. 8, 109.
[8] Fox, R., Krugman, D., Fletcher, J., Fischer, M. (1998). Adolescents'
attention to beer and cigarette print ads and associated product warnings.
Journal of Advertising v27 i3, 57.
[9] Myers, M., Iscoe, C., Jennings, C., Lennox, W., Minstry, E., Sacks, A.
(1981). Staff report on the cigarette advertising investigation,
Washington, DC: Federal Trade Commission.
[10] Stern, B., & Harmon R. (1984). The Incidence And Characteristics Of
Disclaimers In Children's Television Advertising. Journal Of Advertising,
13 (2), 12-16. See Also: Stutts, M., & Hunnicutt, G. (1987). Can Young
Children Understand Disclaimers In Television Commercials? Journal Of
Advertising, 16 (1), 41-46. See Also: Muehling, D., Kolbe, R., A
comparison of children's and prime-time fine-print advertising disclosure
practices. Journal of Advertising, Fall 1998 v27, 37.
[11] Kolbe, R., & Muehling, D. (1995). An investigation of the fine print
in children's television advertising. Journal of Current Issues and
Research in Advertising, 17 (2), 77-95.
[12] Preston, I. (1989). The Federal Trade Commission's identification of
implications as constituting deceptive advertising. 57 U. Cin. L. Rev. 1243.
[13] Spievack, J. (1997). Direct ads may create liability dangers:
consumer advertising by drug manufacturers has reopened the issue of
expanded liability. The Nat'L L. J B1 n.47, 19.
[14] Razen, J. (2002, February). The Consumers and the learned
intermediary in health care. N Engl J Med, V l. 346, N . 7, 523.
[15] Avorn, J., Chen, M., & Hartley, R. (1982). Scientific Versus
Commercial Sources of Influence on the Prescribing Behaviors of Physicians.
American Journal of Medicine. 73 (1). 4-8.
[16] Lazarfield, P., Berelson, B., & Gaudet, H. (1948). The People Choice,
2nd., New York, Columbia University Press. (First Edition at the year of
1944). In its most rudimentary form, the two-step model asserted that
"ideas often flow from radio and print to the opinion leaders and from them
to the less active sections of the population."
[17] Direct-to-Consumer Advertising of Prescription Drugs; Withdrawal of
Moratorium, 50 Fed. Reg. 36,667 (1985).
[18] Peri, M., & A. Nelson. (1987). An Exploratory Analysis of Consumer
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Journal of Health Care Marketing 7, 1 , 9-17.
[19] Medical Advertising News, 1989; Advertising Age, 1989.
[20] Advertising Age, 1989.
[21] Chicago Tribune, 1988.
[22] Colford, P. (1997, October). DTC ads: Just what the doctor ordered.
MEDIAWEEK, v7 n39, 46-49.
[23] Act of March 21, 1938, Ch. 49, 52 Stat. III (codified at 15 U.S.C. 55
(a)).
[24] 21 C.F. R. § 202.1 (1999).
[25] See 21 C.F. R. § 202.1 (1999).
[26] Rosenthal, M., Berndt E., Donohue, J., Frank, R., Epstein, A. (2002,
February). Promotion of prescription drugs to consumers. N Engl J Med, V l.
346, N . 7, 498. See also: Holmer, A. (1999, January). Direct-to-consumer
prescription drug advertising builds bridges between patients and
physicians. The Journal of the American Medical Association, v281 i4,
380.
[27] Ibid. 498.
[28] Razen, J. (2002, February). The Consumers and the learned
intermediary in health care. N Engl J Med, V l. 346, N . 7, 523.
[29] Bell, R., Kravitz, R., Wilkes, M. Direct-to-Consumer Prescription
Drug Advertising and the Public. Journal of General Internal Medicine
14 (11), 651-657.
[30] Wolfe, S., Public Citizen Health Research Group. Direct-to-consumer
advertising – education or emotion promotion? N Engl J Med, V l. 346, N .
7, 524.
[31] A study based on a national survey conducted during the spring of
1998 with technical assistance from the Food and Drug Administration.
[32] Spurgeon, D. (1999, November). Doctors feel pressurized by direct to
consumer advertising. British Medical Journal, v319 i7221, 1321.
[33] Holmer, A. (2002, February). Direct-to-consumer advertising –
strengthening our health care system. N Engl J Med, V l. 346, N . 7, 526-528.
[34] Bell RA, Wilkes MS., & Kravitz RL. (1999). Advertisement-induced
prescription drug requests: patients' antidpated reactions to a physician
who refuses. J Fam Pract. 48, 446-452.
[35] Robinson, J.. (1976). Interpersonal influence in election campaign:
two step flow hypotheses. Public Opinion Quarterly, V. 40, I.3, 306.
[36] Troldahl, V., & Van Dam, R. (1965-1966). Face-to-face communications
about major topics in the news. Public Opinion Quarterly 29, 626-624.
[37] The first study that examined the two step flow model within a mass
media to leader physician to follower physician context. See: Menzel, H.,
& Katz, E. (1955). "Social relations and innovation in the medical
profession: The epidemiology of a new drug," Public Opinion Quarterly 19
(4), 337-352. See also: Coleman J., Katz, E., Menzel, H. (1957). "The
diffusion of an innovation among physicians," Sociometry 20(4), 253-270.
[38] Lin, N. (1973). The study of human communication. Indianapolis:
Bobbs-Merrill.
[39] Robertson. 317.
[40] Stone, G., Singletary, M., & Richmond, V. (1999). Clarifying
communication theories, a hands-on approach. Iowa State University Press.
[41] Troldahl, V. (1966-1967). A field test of a modified "Two-Step Flow
of Communication" model. Public Opinion Quarterly, V. 30, I. 4, 609-623.
[42] Robertson. 309.
[43] Chaffee, S. (1972). The interpersonal context of mass communication
in Kline, F., Tichenor, P. Current perspectives in mass communication
research. Beverly Hills, CA: Sage, p. 95-120.
[44] Menzel, H., & Katz, E. (1955). "Social relations and innovation in
the medical profession: The epidemiology of a new drug," Public Opinion
Quarterly 19 (4), 352.
[45] Precursor to another medical article of the similar topic: Coleman
J., Katz, E., Menzel, H. (1957). "The diffusion of an innovation among
physicians," Sociometry 20(4), 253-270.
[46] Menzel & Katz., 342.
[47] Ibid., 343.
[48] Ibid., 352.
[49] http://www.fda.gov/cder/ddmac/research.htm
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