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DTCA from a Consumer Perspective
Direct-To-Consumer-Advertising
of Prescription Medicines:
A Consumer Perspective
Prepared by:
Associate Professor Michael Harker
Associate Professor Debra Harker
Research Assistance: Colin McFarland
David Rice
Peter Rundle-Curry
From the Social Marketing and Advertising Research Team,
University of the Sunshine Coast
For The Foundation for Advertising Research
February 2006
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DTCA from a Consumer Perspective
Executive Summary
INTRODUCTION
Populations of industrial nations are ageing and experiencing longer life-spans. People
generally are becoming more interested and involved in healthcare and the expenditure
on healthcare is increasing across the developed nations. In the 21st Century informationrich environment, consumers are becoming better-informed in their consumption
behaviour, and healthcare is no exception to the trend. Pharmaceutical companies use a
number of techniques to inform, persuade, educate, advise and warn their various markets
about the prescription drugs that they make and market. This study focuses on Direct-toConsumer-Advertising (DTCA) from the perspective of the Consumer and addresses two
questions:
1. What is the nature and scale of DTCA to consumers?
2. What are the effects of DTCA on consumer knowledge,
attitude and behaviour with respect to healthcare?
DIRECT-TO-CONSUMER-ADVERTISING DEFINED
‘DTCA is any paid form of non-personal communication of prescription medicines by
manufacturers and distributors, the effect of which is to induce the prescription, supply,
purchase and/or use of those prescription medicines’ (World Health Organisation 2005,
Kotler and Keller 2006).
STUDY METHOD
A systematic review of the literature and evidence relating to DTCA and the consumer
was undertaken. The systematic review process was used because it is relevant, rigorous
and transparent. This approach is rare in the social sciences. It was not possible to include
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DTCA from a Consumer Perspective
a meta-analysis because of the heterogeneity of research approaches used in the literature
studied.
FINDINGS
Introduction
DTCA is only permitted in the United States of America and New Zealand but has been
considered in other developed nations.
The world spends in excess of US$3,000 billion on general healthcare. The world market
for pharmaceutical medicines is worth over US$400 billion per annum. US companies
spend over US$30 billion on Research and Development (R&D) into new treatments.
The US prescription drugs market is worth around US$220 billion. US Pharmaceutical
Companies spent around US$25 billion on promotions in 2003, 88% of which was on
traditional marketing methods, for example sampling, or detailing (personal selling by
pharmaceutical representatives), whilst 15% was spent on DTCA (Intercontinental
Marketing Services (IMS) Health 2003).
The DTCA debate in the literature has concentrated on the ‘pros’ and ‘cons’ of the
process to the virtual exclusion of evidence-based position statements.
The critics
express concern about consumer safety, increased costs and patient-doctor relationships,
whilst the proponents stress patient awareness of conditions, treatment alternatives,
compliance and a heightened involvement in their healthcare (Baukus 2004).
Communication Theory and Practice
Healthcare is a ‘high involvement’ consumer ‘service’, hence consumers will need, and
will search for, balanced information to help in decision making. Older people are the
dominant consumers in the market for prescription medicines.
Today’s consumers are more vociferous and active in the healthcare process than
previously; the doctor is still influential in the decision process but some acquiescence to
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DTCA from a Consumer Perspective
patients’ demands has been demonstrated (Kelly 2002, Kravitz, Epstein, Feldman, Franz,
Azari, Wilkes, Hinton and Franks 2005).
Consumers and close carers need and search for information on healthcare issues; the
intensity of the search is influenced by the physical and mental condition of the
consumer, and age, sex and income levels. People who have a favourable attitude
towards DTCA are more likely to be influenced by DTCA messages.
TV is a well-used medium in DTCA with problem-solution and emotional appeals
frequently chosen. Magazines are most popular with women consumers but many people
do not read all the copy and ‘skim through’ brief summaries. The internet is an important
source of information and the integrated approach of TV and Internet has high attention
and credibility. Doctors are a highly credible and trusted source of information. The
effects of DTCA are likely to be mediated by doctor preferences.
Advertisements that present arguments ‘for’ and ‘against’ the medication, rather than ads
that just present the benefits of the drug are more effective communications. This is
borne out by supporting communication theory, and also the practice of DTCA regulation
in New Zealand and the United States, where both benefits and some risks of advertised
medicines are presented.
Consumer Protection and Regulation
It is a consumer’s right to be informed (USA – Kennedy 1962, cited in Pope 1991) and
‘everyone has the right to freedom of expression, including the freedom to seek, receive
and impart information and opinions of any kind’(New Zealand – Chen Palmer 2000).
The purpose of advertising self-regulation is the improvement and achievement of higher
standards of advertising and therefore consumer protection. However, punishment is
expensive, time-consuming and destructive under command regulation, whilst persuasion
is efficient in building trust and relationships under self-regulation that will deliver a
similar outcome for society.
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DTCA from a Consumer Perspective
In the United States the consumer is protected by the government body, the Food and
Drug Administration (FDA), whist in New Zealand the consumer is protected by an
industry self-regulatory body (the Advertising Standards Authority (ASA)) and
Researched Medicines Industry (RMI). Both systems work well, but differ significantly
in costs and flexibility.
The Practice
The populations of industrialised nations are ageing; in the United States the ‘boomer’
generation accounts for 80 million consumers and the ‘mature’ accounts for 52 million
consumers. American consumers ‘buy’ on average 9 prescriptions each per year and by
the age of 45 years 50% of Americans and over 45% of New Zealanders are prescribed at
least one prescription drug. However, 80% of Americans feel confident about the safety
of prescription drugs sold in the USA.
Ninety-six percent of US citizens are aware of advertised medicines and 32% of
consumers who had seen an advertisement talked to their doctors about an advertised
drug, while 57% of consumers searched for additional information on the internet. The
top 20 drugs account for 58% of DTCA expenditure in the USA (Prevention 2004).
In New Zealand, the high awareness levels of DTCA match those in the USA and
awareness of benefits are above 80% in both countries, but risk information recalled in
New Zealand is much lower than the US (30% v 80% respectively). However a ‘great
majority’ of New Zealand patients neither asked for, nor received, a prescription as a
result of DTCA (Hoek, Gendall and Calfee 2004). Further, the surveys suggest that
consumers do not share many of the concerns raised about DTCA on their behalf.
In Australia DTCA is not allowed although companies run ‘disease awareness’
campaigns and, according to Healthy Scepticism (www.healthyskepticism.org) over
AUS$1billion is spent on drug promotion in Australia per annum.
The Australian
Consumers’ Association (ACA) fears that DTCA would place too much pressure on the
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DTCA from a Consumer Perspective
Pharmaceutical Benefits Scheme and suggests that pharmaceutical companies are finding
‘sneaky ways’ of getting around the Australian Therapeutic Goods Act. The regulation
of pharmaceutical marketing in Australia is administered by Medicines Australia, an
industry body. The ACA found that this body was ‘doing its job’.
Educating Consumers
The ‘consumer welfare’ effect of DTCA, whereby advertising provides information to
consumers that taps unmet but medically significant conditions, for example
hypertension, oesophagus and stomach problems, and high cholesterol, has been
confirmed by a number of rigorous studies. 43% of new diagnoses were ‘high priority
conditions (Berndt 2005).
‘Well informed consumers are the bedrock of an efficiently operating market’
(Presidents’ Advisory Healthcare Commission), and the FDA confirmed that DTCA
served public health functions by increasing patient awareness of diseases that could be
treated and prompted thoughtful discussions with doctors (Aikin, Swasey and Braman
2004).
More than half of adults who were interested in an advertisement for medication took
action after seeing the ad.
Most consumers sought information from their doctor as a
result of DTCA – higher than any other source, and the doctor was the most trusted
source of information at 95% (White et al 2004). Although ads were useful in initiating
doctor discussions, some older consumers found them confusing. But over 61% of
consumers in a national survey in the United States disagreed with the statement:
‘Ads for medications should only be in medical journals.’
(ORC 2002)
DTC ads are monitored by the FDA in the USA and in New Zealand all prescription
drugs ads must comply with the Medicines Act 1981 and Medicine Regulations 1985.
The 1996 Code of Therapeutic Advertising (revised in 1999); introduced by the
Advertising Standards Authority, lays down strict conditions for all therapeutic ads and
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DTCA from a Consumer Perspective
100% compliance with decisions by the industry is achieved.
There is a plan to
harmonise the legislation between New Zealand and Australia on the authorisation,
administration and promotion of medicines.
Consumer Reaction to DTCA
Consumer reaction to DTCA in the United States has been tracked through a longitudinal
study by Prevention magazine, confirmed by two FDA surveys. The overall consumer
attitude towards DTCA was positive (Calfee 2002) and ‘consumers like DTCA’
(Deshpande, Menon, Perri and Zinkhan 2004). DTCA increased consumer awareness of
new drug treatment, and 93% of consumers said that doctors welcomed their questions
about prescription treatment. There was some concern from consumers about the clarity
of information in broadcast ads.
Spill over benefits of DTCA included better compliance with drug therapies (Calfee
2002).
However, this finding has been questioned by some researchers because the
Prevention survey does not measure behaviour and would be unable to predict what
patients did in response to advertising (Mintzes 2002). Kravitz, in his study, took us into
the doctors’ surgeries and found that there was evidence of under-treatment of some
conditions and over-treatment of less serious conditions (Kravitz et al. 2005). This study
raises some interesting questions about the prescribing behaviour of physicians.
A
comprehensive study by Choudry, Fletcher and Soumerai (2005) indicated that patients
were receiving less than adequate healthcare from some doctors who were failing to
conform to appropriate therapy standards; specifically there was a negative association
between the age of the doctor and adherence to appropriate therapy standards.
Detailing by pharmaceutical sales representatives, that is a personal ‘sales’ call to inform
and persuade doctors about treatments, has been found to play a more important part in
medication choice than DTCA in the antidepressant market (Donohue and Berndt 2004).
However, Mintzes and her colleagues found that American doctors were more likely to
prescribe an advertised drug than their Canadian counterparts where DTCA is banned
(Mintzes, Barer, Kravitz, Bassett, Lexchin, Kanzanjian, Evans, Pan and Marion 2003). In
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DTCA from a Consumer Perspective
a report for the Health Council of Canada, Mintzes (2006) has attempted to re-open the
debate on DTCA in Canada, claiming that the proponents of DTCA have failed to
produce convincing evidence for their claims. From a consumer perspective, there is
robust evidence from the industrial economists concerning the beneficial welfare effects
of DTCA (Berndt 2005) and a number of large surveys have shown that DTCA provides
useful information to consumers on conditions and treatments of ailments (Aiken et al
2004).
Consumers do not appear to share many of the concerns expressed on their behalf (Hoek
et al. 2004). But consumers are, however, much more interested in their healthcare and
the balance of power between doctor and patient is changing as consumers interrogate
and become better informed from the numerous databases available to them. Eight out of
ten patients who visited their doctor to discuss a condition as a result of DTCA did in fact
suffer from that condition. Doctors, for their part, under increasing pressure for cost
control, and from policy changes of governments and health plans, find it increasingly
difficult to manage busy practices and devote adequate time to their patients (Gallagher
and Levinson 2004). Doctors found patients better informed but were concerned with the
time taken to discuss patient misconceptions about conditions and treatments (Weissman,
Blumenthal, Silk, Zapert, Newman, and Leitmann 2004).
There has been concern in some quarters that consumers were being persuaded, by
DTCA, that non-medical conditions have become defined and treated as medical
conditions (Lexchin and Mintzes 2002); for example toenail fungus, baldness and erectile
dysfunction. Costa (2005) has suggested that dementia and osteoporosis are part of the
ageing process and are being ‘medicalised’ by the pharmaceutical industry. Although the
pharmaceutical industry spends over US$30 billion each year in the United States on
Research and Development, it has been suggested that ‘at best only one-third of new
drugs offer some additional clinical benefit and perhaps as few as 3% are major
therapeutic advances’ (Lexchin and Mintzes 2002). Other researchers have highlighted
the epidemiological evidence showing ‘substantial under-diagnosis’ of major diseases
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DTCA from a Consumer Perspective
and the known risk factors for which treatments exist (Meek 2001, Bonaccorso and
Sturchio 2002).
The medicines that have been growing most quickly in consumer awareness terms are
Nexium (for reflux/ulcer ailments) and Lipitor (for high cholesterol) (Prevention 2004).
In the last 20 years the FDA has moved more than 600 drugs from prescription to OTC
status. But if there has been an increase of medicalisation through rising consumerism
and industry zeal, insurers and governments have acted quickly to correct the balance
(Conrad and Leiter 2004).
There is strong evidence from the literature that DTCA increases demand for the
advertised drug class. Three important studies by economists used interrupted time-series
analyses with before-after measures to measure the impact of DTCA on consumer
behaviour (Basara 1996, Zachry, Shepherd, Hinich, Wilson, Brown and Lawson 2002,
Jong, Stricker and Sturkenboom 2004). The time-series studies indicated that DTCA was
effective in increasing prescribing volume for advertised drugs for migraine, statins and
for a fungal nail condition.
It has been argued that pharmaceutical companies charge high prices for new drugs and
those drugs are promoted selectively (Kaiser 2003).
A comprehensive study by
Anantharaman, Anju and Shepherd (2005) found a weak relationship between DTCA and
price for 20 heavily-advertised drugs, and concluded that DTCA costs ‘did not drive price
increases’ (p. 15). It has also been argued that some new drugs are more expensive, as
companies endeavour to recover high R&D investments. However, newer drugs are
more effective and help to lower the costs of non-drug spending; for example, replacing a
15 year-old drug with a new one increases drug costs by US$18 but reduces overall costs
on average by US$100 (Auton 2004).
A number of studies have investigated how effective DTCA is for the Pharmaceutical
companies; that is how much additional revenue is generated by one more dollar invested
in DTCA. The average rate of return was around US$2.20 for each dollar invested, but
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DTCA from a Consumer Perspective
the rate of return on investment in representative detailing visits was 5 times this sum
(Arnold 2005). To put marketing expenditures by drug companies into perspective,
detailing outspends DTCA by a factor of two to one, and sampling out-spends DTCA by
almost four to one (Auton 2004).
CONCLUSIONS
DTCA has been the subject of much basic descriptive research that has provided some
useful insights into DTCA and the consumer. The Prevention studies have been valuable
as they provide information of trends in consumer awareness, knowledge and attitudes
over time; these studies were also confirmed by FDA work in 1999 and 2002. Such
descriptive studies have value in that they explore the ‘who’, ‘what’, ‘when’ and ‘where’
questions, but they are unable to answer the important questions of ‘why’ and ‘how’.
The research studies have not explored in any depth the basic behavioural issues, that is
‘why do people do what they do, and what influences this behaviour?’ The studies have
provided little insight into the following well known dilemma:
‘Half of the money that we spend on advertising is wasted, but we do not know which
half.’
(Lord Leverhulme)
DTCA spending is currently running at over US$4 billion worldwide (Arnold 2005) yet
much of the research into the area does not attempt to address the conundrum raised by
Lord Leverhulme.
For almost two decades now the opponents and proponents of direct-to-consumeradvertising of prescription medicines have waxed lyrical in their attempts to develop
convincing arguments to ‘prove’ their case.
The arguments have remained largely
unchanged and it has become clear that rhetoric, no matter how often or how long it is
repeated, does not advance understanding of the issues involved in DTCA. There is a
need for sound data and ‘good quality evidence’ (Australian Consumers’ Association
2006).
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DTCA from a Consumer Perspective
Most of the work that is available and that we have reviewed in this report is of an
‘exploratory’ or ‘descriptive’ nature and has dealt with the question:
‘What is the nature and scale of DTCA?’
However, in order to answer the question:
‘What are the effects of DTCA on consumer knowledge, attitude and
behaviour with respect to healthcare?’
We have reviewed descriptive and more limited causal research.
We have seen that DTCA has enjoyed a steady growth and has endeavoured to provide a
balance of information for interested stakeholders; on occasions with the help and
guidance of regulatory bodies. DTCA uses a number of media to communicate its
messages and a number of appeals. TV and the internet are becoming dominant in the
integrated marketing communications mix used by companies, as complex messages can
be managed effectively and efficiently on company websites. Some of the emotional
advertising appeals used on TV have angered critics of DTCA and on many occasions
pharmaceutical companies have been criticised for failing to provide information with the
required ‘balance’ of benefit and risk.
The DTCA Model
There is much descriptive research that has helped us to explore the way in which DTCA
affects consumer awareness, knowledge and attitudes. Some insight and understanding
of the way that this market works and is influenced can be obtained by analysing a
model, the ‘hierarchy of effects,’ developed by Lavidge and Steiner (1961) and since
modified in a healthcare context by Menon et al. (2004). The model postulates that
advertising messages affect consumer behaviour in a hierarchical manner from a state of
unawareness of a condition or drug, through awareness, attention, comprehension,
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DTCA from a Consumer Perspective
attitude, drug inquiry, drug request, and compliance with drug regimen; the whole
process regulated through consumer rights, knowledge, empowerment and protection.
Consumer
Rights
Adherence to drug regimen/refill behaviour
C
o
n
s
u
m
e
r
Drug request behaviour
Drug inquiry intent
Info search using sources of adequate provision
E
m
p
o
w
e
r
m
e
n
t
C
o
n
s
u
m
e
r
Attitudes towards DTCA
Comprehension of drug risks and benefits
Awareness of DTCA and drug indication,
recall and recognition of ad and drug
Attention to DTC ad
K
n
o
w
l
e
d
g
e
Aware – result of DTCA
Unaware of Condition (drug)
Consumer
Protection
(Source: Developed from authors referenced in this study)
In summary, the hierarchy of effects model provides a useful framework for gaining
greater insight into the effectiveness of DTCA. The descriptive research that we have
reviewed indicates:
•
DTCA appeared to increase consumer awareness of conditions and treatments.
•
DTCA has assisted consumers to discuss conditions and treatments with their
physicians.
•
Consumers are apparently now taking more responsibility for their own
healthcare.
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DTCA from a Consumer Perspective
•
DTCA has been less effective in terms of consumer comprehension of drug
benefits and risks.
•
Whilst drug request behaviour has remained constant over time in the United
States, there are some indications that DTCA has been effective in encouraging
drug compliance.
It has been said that ‘the absence of evidence is not evidence of absence’ (Rosenthal,
Berndt, Donohue, Frank, and Epstein 2002) but the extent and effect of DTCA have yet
to be summarised in a comprehensive, relevant and rigorous manner. In company with
Gilbody, Wilson and Watt (2005), we were unable to find significant studies that actually
demonstrated the impact of DTCA on consumer behaviour; specifically what did
consumers do differently as a direct result of DTCA?
We were keen to find and
interrogate studies that gave some insight into the ‘why’ and ‘how’ of consumer
behaviour in the healthcare market.
Five rigorous studies provided further insights. The first three studies were interrupted
time-series analyses with before-after measures (Basara 1996, Zachry et al. 2002, Jong et
al. 2004), and the last two studies were quasi-experimental designs with control groups
(Mintzes et al. 2003, Kravitz et al. 2005). The time-series studies indicated that DTCA
was effective in increasing prescribing volume for the advertised drugs, whilst the
controlled experiments gave some insights into the prescribing behaviour of doctors in
consultation with patients (Mintzes et al. 2003, Kravitz et al. 2005). The final study by
Kravitz et al. raises some interesting questions about the prescribing behaviour of
physicians.
These five important studies have given us the first real insight into the effects of
advertising on consumer healthcare behaviour because they are able to isolate the effects
of advertising from all the other variables that could affect that behaviour. All these
researchers have conceded the limitations of their studies that affect the interpretation of
the results. However research is an iterative process and, although rigorous research is a
‘late starter’ in the DTCA field, a bold start has been made and the foundations have been
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DTCA from a Consumer Perspective
laid for rigorous future research. We must learn much more of how and why consumers
and healthcare providers behave in the way that they do.
However, the DTCA literature is increasing in scale and complexity. In summary, the
descriptive and causal research studies that we have evaluated in this systematic review
of the DTCA literature from a consumer perspective has provided valuable insights into
the nature, extent and effects of direct-to-consumer-advertising of prescription medicines:
•
Consumers are more aware of conditions and treatments.
•
DTCA increases the demand for treatments and medicines.
•
Consumer attitudes towards DTCA are more positive in countries that have
DTCA than those that do not.
•
Some consumers are better educated about conditions and treatments.
•
Some consumers are better prepared for doctor discussions.
•
Many doctors welcome informed discussions from patients.
•
There appears to be a DTCA information problem for consumers in relation to
risks and benefits of treatment.
•
DTCA can facilitate the compliance process.
•
DTCA appears to influence prescribing behaviour of doctors. Some doctors, for
example, feel a need to meet the requests of some patients (Mintzes et al. 2003).
•
There is evidence of some under-treatment and some over-treatment by doctors of
certain conditions (Kravitz et al. 2005).
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DTCA from a Consumer Perspective
Table of Contents
Executive Summary .......................................................................................................... 2
Introduction..................................................................................................................... 16
Study Method – The Systematic Review....................................................................... 18
Part 1 The Theory........................................................................................................... 21
1.
Consumer Needs..................................................................................................... 21
2.
The Buying Decision Process ................................................................................ 22
3.
Communication Models......................................................................................... 24
4.
Consumer Protection and the New Social Regulation........................................ 42
Part 2 The Practice ......................................................................................................... 51
5.
The Industry ........................................................................................................... 51
6.
The Consumer – Changing Markets, Changing Consumers ............................. 54
7.
DTCA and Regulation – The Practice ................................................................. 56
8.
Educating Consumers and Patients ..................................................................... 62
9.
Consumer Reaction to DTCA – The Practice ..................................................... 67
10.
DTCA and the Patient-Doctor Relationship........................................................ 73
11.
The Consumer and Medicalisation....................................................................... 77
12.
DTCA, Economics for the Consumer and Prices................................................ 81
13.
Conclusions............................................................................................................. 84
14.
References............................................................................................................... 93
Appendix........................................................................................................................ 106
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DTCA from a Consumer Perspective
Introduction
New Zealand and the United States are the only two advanced countries that permit direct
to consumer pharmaceutical advertising.
Direct-to-consumer-advertising (DTCA) of
medicines developed in these two nations since it was not prohibited and has since been
accommodated by existing laws (Hoek, Gendall and Calfee 2004). DTCA of prescription
medicines differs from almost all other advertising in two respects; first the consumer
must acquire a prescription from a medical practitioner prior to purchase and, second,
DTCA is strictly regulated. The practice of advertising prescription drugs by
pharmaceutical companies began in America in 1985 and in New Zealand in the early
1990s. In 1997 the Food and Drug Administration (FDA) in the United States relaxed the
regulations governing advertising to the mass market, thus making DTCA an attractive
and viable alternative to the traditional approach of communicating directly to doctors.
As DTCA increased in the late 1990s, mainly on TV to targeted groups of consumers, the
debate about the practice intensified to feverish proportions. For almost two decades now
the opponents and proponents of DTCA have distilled sets of arguments that have
remained largely unchanged and that have been repeated ad nauseum in journals,
periodicals and special reports. For example, see Meek (2001), Lexchin and Mintzes
(2002), Auton (2004), Eagle and Chamberlain (2004), Iizuka (2004), the Australian
Consumers’ Association (2004), and Richardson and Luchsinger (2005). Specifically,
the critics express concern about consumer safety, increased costs and patient-doctor
relationships, whilst the proponents stress patient awareness of conditions, treatment
alternatives, compliance, and a heightened involvement in their healthcare (Baukus
2004).
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DTCA from a Consumer Perspective
This, current study was narrower and more focused than much of the preceding work as it
was concerned with the impact of DTCA on the CONSUMER. Specifically, the study
explored:
1. The nature and scale of prescription drug advertising to
consumers.
2. The effect that DTCA had on consumer knowledge, attitude and
behaviours with respect to healthcare.
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DTCA from a Consumer Perspective
Study Method – The Systematic Review
The study method adopted for this research used systematic procedures to explore the
extent and effect of DTCA on consumers. The systematic review approach was taken
from the medical sciences where great care is taken to make sure those treatments are
safe and effective and that every possible source of evidence is identified and rigorously
evaluated. A systematic review is:
‘a review of the evidence on a clearly formulated question that uses systematic, and
explicit methods to identify, select and critically appraise relevant primary research.’
(Khan, Riet, Glanville, Sowden and Kleijnen 2001)
The exact nature of this search, evaluation and verification process is recorded in a
detailed protocol that other researchers can use to replicate the process and validate the
conclusions reached. Systematic reviews are relevant, rigorous and transparent and have
been rarely used in exploring social phenomena (Hastings, Stead, Mcdermott, Forsyth,
Mackintosh, Rayner, Godfrey, Caraher, Angus 2003).
Marketing is a complex process that is planned to influence consumer behaviour, and
advertising and promotion are important elements in the influencing process. It has been
demonstrated that consumers are actively involved in the consumption of DTCA of
prescription drugs (Calfee 2002), and that consumers are not passive or easily
manipulated. However, the effects of advertising are multiple and pervasive including
knowledge, attitude, and behaviour changes on the part of patients, doctors, stakeholders
and significant others.
Developing effective advertisements for mass markets and measuring the effectiveness of
these ads is a difficult and costly process, and a number of techniques have been used to
assess effectiveness, including consumer studies, econometrics, and experiments
(Hastings et al. 2003). It was our task to seek out, select and critically assess the key
studies that have explored the extent and effect of DTCA of prescription medicines on
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DTCA from a Consumer Perspective
consumers. We also planned to assess the extent to which key studies have made a real
and significant contribution to our knowledge on DTCA.
The method that we chose for this DTCA study was the systematic review process that is
used so widely in the medical sciences.
The work of Hastings and his team was
influential in the decision to use systematic procedures for this study for two main
reasons.
First, the systematic review process would deliver rigorously achieved,
evidence-based findings that would be relevant and acceptable to the key stakeholders in
the DTCA of prescription drugs process and debate. Second, as far as we knew, a
systematic review of the literature from the consumer’s perspective relating to the DTCA
of prescription medicines had not been previously undertaken (Hastings et al. 2003).
Method
We carried out a systematic review of the literature in line with the guidelines set out by
Khan et al. (2001) and our results are presented according to the guidelines laid down in
the Quality Of Reporting Of Meta-analyses (QUOROM) statement (www.consorstatement.org/QUOROM.pdf 2005). Details of this process can be found in the appendix
to this report. It was not possible to extend the review into a formal statistical method
synthesis or meta-analysis because of the heterogeneity of the studies explored.
In the process of our searches, we identified work by Wazana (2000) who carried out a
modified systematic review of research that explored the extent to which doctor-industry
interactions influenced the prescribing behaviour of doctors. Another study by Gilbody
and his colleagues from York University in the United Kingdom described a systematic
review of the literature dealing with clinical and economic impacts of DTCA on patients
and clinicians (Gilbody, Wilson and Watt 2005). Although much broader in scope than
our study, this ground-breaking work provided some valuable support to our review
processes and validation of our findings (as this study does to theirs).
Three main methods were used to identify potentially relevant research reports: an
extensive search of electronic databases, a review of the ‘grey’ literature, and personal
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DTCA from a Consumer Perspective
contacts with key people in the field, notably in the United States, Canada, the United
Kingdom, New Zealand and Hong Kong.
Only academic articles that were peer-
reviewed were included in this systematic review.
An extensive search of relevant databases from 1987 to October 2004 coincided with the
study by Gilbody et al. (2005), and a search of the data bases from October 2004 to
October 2005 provided a more current view of the field. The main databases interrogated
were ABI/Inform Global, Academic Research Library, AMA Titles, Oxford Journals
(Health Education Research), Health & Medical Complete, Pharmaceutical News Index,
Proquest Social Science Journals, Proquest 500, HSRProj, NHS, Medline & Medline
Plus, Psycinfo, Blackwell-Synergy, Informit, Meditext, AMI, JAMA and Ovid.
These searches yielded 1,036 potentially relevant samples that underwent an initial
assessment. Some 684 pieces of research gave insight into the nature and extent of
DTCA. We then excluded studies that only reported knowledge and awareness of
advertising campaigns but included studies that used control groups or multiple-measure
interrupted time-series; in other words studies that addressed the question of the impact
of DTCA. We were left with 5 articles that demonstrated some causality between
investigated variables. See Appendix for a full explanation of this methodology.
Most of the studies revealed by this rigorous methodology were from the United States of
America and it would be erroneous to generalise these studies to the world at large and in
particular to New Zealand.
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DTCA from a Consumer Perspective
Part 1 The Theory
The World Health Organisation defines medicinal drug promotion as:
‘All informational and persuasive activities by manufacturers and distributors, the effect
of which is to induce the prescription, supply, purchase, and/or use of medicinal drugs.’
(World Health Organisation 2005)
DTCA of prescription medicines is defined as:
‘… Any paid form of non-personal presentation of brand specific prescription drugs by a
sponsor through the mass media.’
(Kotler and Keller 2006, Eagle and Chamberlain 2004)
1.
Consumer Needs
According to Maslow (1970), consumers’ needs are arranged in a hierarchy from basic
survival needs such as physiological and safety needs, to needs for self actualization. The
need for sound health or to survive would appear to be a basic physiological need
(Maslow 1970). A market segment consists of a ‘group of customers who share a similar
set of needs and wants’ (Kotler and Keller 2006, p. 240). The healthcare market has been
traditionally segmented by age and disease – indicating the positive relationship between
age and need for treatments. Markets are also divided up on the basis of gender, ethnicity
and attitude; and pharmaceutical companies have no doubt addressed segmentation
strategies in an innovative manner. Older people constitute the largest market segment in
terms of age.
21
DTCA from a Consumer Perspective
2.
The Buying Decision Process
The ‘Buying Decision Process’ is a stage model developed by marketing scholars to try
to understand the way in which consumers behave in the marketplace. The model
proposes that consumers pass through five stages in making a product choice, namely
problem recognition (pain/discomfort/information about a condition), information search
(for example, internet sites – informedhealthonline.com, pharmaceutical websites), and
evaluation of alternatives (family member, friend, carer, and pharmacist), purchase
decision (physician), and post-purchase behaviour (physician) (Kotler and Keller 2006).
If the decision is a ‘high involvement’ one (as opposed to low involvement), the
elaboration likelihood model developed by Cacioppo and Petty (1979) gives some insight
into how consumer attitudes are formed and changed in the decision process as they
source and evaluate information.
Marketing scholars have studied the working of advertising in the information processing
framework in which the consumer is seen as an information processor (Huh and Becker
2002). The consumer processes the information received from the advertisement through
a number of response steps, according to Lavidge and Steiner (1961), conceptualized as
awareness, interest, liking, preference, conviction and purchase. It has been shown many
times that a positive attitude towards the advertisement influences the attitude towards the
brand, and these impacts positively on the likelihood of purchase of that brand (Huh and
Becker 2002).
Emphasising the difference between the conventional business-to-
consumer transaction and the more complex healthcare transaction, Menon, Deshpande,
Zinkhan and Perri (2004) propose an advertising effectiveness model that encompasses
the observed differences between the transactions and this is discussed in more detail
later. The authors add that DTCA is affected by a number of predictor variables, such as
audience characteristics (for example, demographics, psychographics, and health), source
characteristics, message characteristics and channel characteristics (Menon et al. 2004).
22
DTCA from a Consumer Perspective
Significantly, the Menon model accepts the premise that patients are now more
vociferous and active in their healthcare decisions than previously. Menon and his
colleagues have shown that new consumer activism and shared healthcare has possibly
replaced the traditional model of doctor-patient relationship with its one-way direction of
information flow and the unquestioning approach of the patient (Menon et al. 2004).
Calfee and his colleagues found that consumer behaviour in this market is influenced by
the increased dissemination of evidence that drugs are effective in treating a given
condition but also by the necessary interactions between patient and doctor before a
prescription is filled (Calfee, Winston and Stemski 2002).
23
DTCA from a Consumer Perspective
3.
Communication Models
According to some commentators (Calfee 2002), from an educational, informational and
consumer empowerment perspective, the benefits of DTCA outweigh possible negative
consequences. Others (Lexchin and Mintzes 2002, Kaphingst and Dejong 2004) however
disagree, asserting that DTCA is merely a promotional vehicle used by pharmaceutical
companies to maximise sales. Regardless of the stance adopted, an analysis of DTCA
literature reveals that this form of message communication influences consumers’
healthcare considerations.
Response hierarchy models, such as attention-interest-desire-action (AIDA), innovationadoption, the communications model, and hierarchy of effects (Shimp 2003), indicate that
as consumers are moved from an unaware state towards purchase and conviction,
individuals pass through cognitive (think), affective (feel) and behavioural (do) stages; in
essence attitude formation. The sequence in which consumers pass through these various
stages is dependent on the level of product differentiation and individual involvement
(Kotler and Keller 2006).
The development of shared meaning in the advertising process is tempered by several
variables, and these are defined as source, message, channel and audience characteristics
(Menon et al. 2004). The term source characteristics refers to the credibility that an
individual places in the source of the originating message, such that a message from a
pharmaceutical company may be perceived to be less credible than from a doctor.
Message characteristics are the type of appeals, format, length, information content and
clarity used in the communication event (Menon et al. 2004). Channel characteristics
refers to the medium used to convey the message and this may take the form of broadcast
(television and radio), print or web-based services (Menon et al. 2004).
Audience
characteristics are the psychographic, demographic and situational elements (Menon et
al. 2004). Once these elements are combined, it is apparent that individuals, consumers,
24
DTCA from a Consumer Perspective
process messages in different ways which, ultimately, impact on their attitude towards
not only the product but also the brand.
3.1.
Elaboration and Purchase Involvement
The Elaboration Likelihood Model (ELM) is defined by Neal, Quester and Hawkins
(2002, p. 276) as a model which attempts to determine ‘how attitudes are formed and
changed under varying conditions of involvement’. The concept of involvement here is
significant as it refers to how important the decision is to the consumer. For example,
buying a piece of rope may be considered a low involvement purchase if it is to be used
for skipping, but a high involvement purchase if it is to be used for a children’s swing.
The ELM (Petty and Cacioppo 1981) also referred to as the Integrated Model of
Persuasion (MacInnis and Jaworski 1989) (Figure 1), presents a number of ways in which
persuasion of consumers occurs. In other words it depicts how an individual arrives at a
favourable or unfavourable attitude pertaining to a particular event, object or product.
25
DTCA from a Consumer Perspective
Figure 1 – The Elaboration Likelihood Model: An Integrated Model of Persuasion
Central
Route
MessageArgument
Processing
EL=
High
Exposure to
Message:
•Message Arguments
•Peripheral Cues
Receiver Motivation,
Ability, and
Opportunity to
Process Message
EL=
Low
Peripheral
Route
Peripheral-Cue
Processing
Cognitive and
Emotional Responses
toward Arguments
Attitude-Formation
Processes
EL=
Moderate
Attitude-Formation
Processes
Enduring
Attitude Change
AB
Temporary
Attitude Change
Cognitive and
Emotional Responses
toward Peripheral Cues
(Shimp 2003, p. 121)
26
DTCA from a Consumer Perspective
The application of cognitive resources in evaluating a message being presented is referred
to as elaboration likelihood (EL). EL is the resultant effect of an individual’s allocation
of cognitive resources to the essence of a particular message, such as an advertisement.
Furthermore, the amount of cognitive resource allocation is dependent on an individual’s
motivation, opportunity and ability to process the message (Shimp 2003).
Motivation reflects the notion of how involved an individual is with the message at hand,
and is said to be high when an advertisement relates to an individual’s immediate
consumption-related goals (Shimp 2003). In the context of DTCA, it has been suggested
that consumers who have an ongoing need for healthcare and those with children are
more likely than others to value DTCA (Gonul, Carter and Wind 2000). Further, ‘present
health condition’ and ‘current prescription drug usage’ are also motivational factors
(Delorme, Huh and Reid 2005).
Perri and Dickson (1988) suggest that the recognition of DTC advertisements is a
function of age, with older persons showing greater recognition rates, and this is
attributed to the fact that older consumers are more aware of their current health needs.
Motivation is, however, somewhat contingent on psychographic and demographic
variables such as age and gender. Female consumers, for example, report higher recall
rates than men with regard to DTCA and this is consistent with research that indicates
females are more likely to take an active role in the management of their health than men.
It has also been suggested that race and ethnicity predispose a consumer to seek out
information (Huh and Becker 2002).
Opportunity involves the ability of an individual to physically process a message. An
individual’s opportunity to process a message may be tempered by both internal factors,
such as the individuals’ educational level which may preclude the development of shared
meaning, and external factors such as distortion in the medium used to present the
message (Shimp 2003).
27
DTCA from a Consumer Perspective
Ability denotes whether an individual is familiar with message claims and is able to
understand them (Shimp 2003). Specifically in terms of health literacy, research suggests
that while consumers may possess the necessary motivation and opportunity they may in
fact not fully comprehend or correctly apply the content of the advertising because they
lack adequate levels of literacy (Brownfield, Bernhardt, Phan, Williams, and Parker 2004,
Kaphingst, Dejong, Rudd, Daltroy 2004). Similarly, research conducted in 1992 by the
National Centre of Education reveals that approximately one quarter of the US population
had difficulty in understanding materials which required rudimentary reading
proficiencies (Curran and Oh 2001). Demographic, education and income variables
affect an individual’s ability to process messages, in DTCA terms this relates to recall
rates and exposure to advertisements (Perri and Dickson 1988, Sengupta 2002).
Figure 1 depicts the routes to persuasion via the ELM, depending on the type of
consumer involvement with the purchase decision, and subsequent elaboration on the
communication presented. An individual’s motivation, opportunity and ability (MOA) to
process messages is important as they essentially determine the route (central, peripheral
or dual) by which they will arrive at a particular attitude toward the brand, whether
enduring or temporary (Shimp 2003).
When an individual is exposed to a message such as that which is contained within a
DTC advertisement, if MOA is high then the central route to persuasion is utilised. Here
the receiver will focus mainly on message arguments rather than peripheral cues. In so
doing the individual will primarily engage in argument scrutiny resulting in sub-vocal
cognitive and emotional responses towards the message presented. The net result of this
process is the determination of whether the persuasive communication influences the
individual’s attitudes (Shimp 2003). Attitude formation developed under the central
route is relatively enduring.
By contrast when an individual is exposed to a message and possesses low MOA then
message arguments are secondary to peripheral features, such as background music and
setting. Peripheral cues result in cognitive and emotional feelings being attached to the
28
DTCA from a Consumer Perspective
product class being advertised. The peripheral route results in attitude formation which is
relatively elastic, or temporary.
Research conducted by Jacoby and Hoyer (1987) assists in developing a greater
understanding of how individuals elaborate on DTCA communications.
Asserted
meaning is expressly stated in the DTCA communication, for example if you take
product X then an antecedent state will be achieved, namely no more illness (the central
route) (Handlin, Mosca, Forgione and Pitta 2003). Implied meanings, on the other hand,
are inferred from the communication such that the receiver builds this meaning into the
communication event and is not explicitly stated by the DTCA communicator (the
peripheral route).
Consumers with little experience or knowledge in assessing risk
information regarding medical terminology contained within a DTCA may conclude that
there is little or no side effects from using the product class viewed.
3.2.
DTCA Appeals and Mechanisms
In considering persuasion techniques employed by DTCA communicators it is important
to recognise that there are several layers to an advertisement whether in print or
electronic format; this includes both visual and non visual cues which must be considered
(Welch and Young 2004). This is important in terms of advertising regulation where, in
the case of DTCA, America’s FDA regulates the advertising copy contained within DTC
advertisements but does not restrict the visual element of the advertisement (Welch and
Young 2004). This is significant when considered in the context of message processing
leading to attitude formation, whether utilising the central, peripheral or dual routes.
Research indicates that visual cues are likely to activate peripheral rather than central
processing routes with regard to the ELM (Welch and Young 2004). Critics of this
regulatory oversight have suggested that the non-regulation of visual elements potentially
allows DTC advertisers to use techniques that create ‘inaccurate impressions in the
consumer’s mind, free from interference by regulators’ (Handlin et al. 2003).
The most persuasive appeal technique used by DTCA communicators is that of fear
through social stigmatisation (Pinto 2000). An individual with a chronic, or socially
29
DTCA from a Consumer Perspective
stigmatised, illness (such as erectile dysfunction or an overactive bladder) risks a
permanent loss of features to their identity (Welch and Young 2004); however, as stated
by Welch and Young (2004, p. 137), ‘to control one’s illness is to control one’s identity’.
This is achieved by ascribing to treatments or medication offered by prescription drug
manufacturers through the acquisition of information presented in DTCA messages.
However, pharmaceutical companies have been criticised in the past for developing the
strategy of medicalising common symptoms that do not require medical treatment
(Lexchin and Mintzes 2002, Woloshin, Schwartz, Tremmel and Welch 2001).
The ELM concludes its analysis at the attitude toward the brand stage. However a related
concept is brand loyalty, whereby satisfied consumers continue to buy the brand. It is
interesting to note that several pharmaceutical companies have developed loyalty
programs to induce repeat purchase. Pfizer, for example in the USA, offers a loyalty card
similar to a frequent buyer program.
3.3.
Consumer Perception of DTCA
Calfee (2002) suggests that consumers have a favourable attitude towards DTCA, which
indicates that consumers are more willing to engage cognitive resources in the
consideration of message claims. This suggestion is supported by Herzenstein, Misra and
Posavac (2004) who found that consumers who have a predisposed favourable attitude
towards DTCA are more likely to be influenced by the advertisement, and this probably
holds for other high involvement products or services. Similarly, if individuals believe
that there is some utility in the information contained within an advertisement then they
are more likely to view the source as credible and therefore serving a useful and valuable
function (Vatjanapukka and Warszak 2004).
Specifically in terms of prescription medicine advertising, it has been found that
advertising does not lower the credibility of the overall product class (Miller and Waller
2004), in fact greater credibility is attributed by consumers to brands that adopt a
seamless approach to integrated marketing communications (specifically the mix of
websites, print and electronic media) (Shelton 2002). According to Castillo and Hopkins
30
DTCA from a Consumer Perspective
(2003) consumers view information in DTC advertisements as more credible than overthe-counter (OTC) advertisements as they feel that the information contained within is
less likely to be misleading or dangerous. This study also found that consumers are more
likely to view DTCA advertisements as an important source of information given the fact
that they find it difficult to distinguish between editorial content and advertisement
content (Castillo and Hopkins 2003).
With regard to the impact of demographic variables, it has been found that DTCA is no
more effective at moving older consumers to act, compared to their younger counterparts
(DeLorme, Huh and Reid 2005), in other words, age is not a significant motivational
factor in terms of persuasive advertising of prescription drugs (DeLorme et al. 2005).
This proposition is supported by Castillo and Hopkins (2003) who indicate that the
general public is interested in DTCA regardless of whether the message is targeted at a
specific niche market. However, a condition known as the truth effect does appear to
have an impact (Hasher, Goldstein and Toppino 1977) on older consumers (Lee, Hawkins
and Craik 1998).
Older consumers are also more likely to be sceptical about persuasive messages; they
tend to be persuaded by the logic of the message rather than message content (Yoon and
Lee 2004).
Furthermore, motivational levels are elevated when the message being
presented is high in personal relevance, regardless of the individual’s ability to
comprehend the message.
Recent research has concluded that demographic factors are not significant in moving
consumers to act as a result of exposure to DTCA specifically; however individuals are
prompted to engage in interpersonal communication with relatives, friends and doctors
about the product viewed (Delorme et al. 2005, Calfee 2002). There is delineation
however between younger and older consumers with regard to this exchange of
information; older consumers appear more likely to engage in conversations with doctors
while younger consumers appear to engage in conversations with friends and relatives
(DeLorme et al. 2005). Mintzes, Barer, Kravitz, Bassett, Lexchin, Kanzanjian, Evans,
31
DTCA from a Consumer Perspective
Pan and Marion (2003), however, found that greater exposure to DTCA merely resulted
in more requests for advertised medicines, and this finding is supported by Basara (1996).
On the other hand, there are studies that show the opposite of these findings. Results
obtained by DeLorme and colleagues (2005) found that older individuals were less likely
than younger counterparts to engage in communications resulting in asking doctors to
write prescriptions for the product viewed.
In a study conducted by the Magazine Publishers of America in 1999, it was noted that
there had been a reduction in the percentage of consumers (from 49% to 36%) who
believed in message claims contained within DTC communications as a result of the
loosening of risk disclosures by the FDA (Handlin et al. 2003).
Individuals are generally aware that the information being presented in DTCA is
promotional in nature and as such must be tempered by an understanding of both benefits
and risks, and they are neither educated nor manipulated by DTCA communications
(Young, Paterniti, Bell and Kravitz 2005). This finding suggests that the regulation of
DTCA is not only vitally important but also evolving in line with consumer perceptions.
However, the non-regulation of visual elements of DTCA in the USA potentially allows
advertisers to use techniques that create inaccurate impressions in the consumer’s mind
(Handlin et al. 2003).
3.4.
Integrated Marketing Communications
Customer-focused marketers have long since appreciated the benefits of using an
integrated marketing communications (IMC) approach to message delivery and, whilst
this model is used widely in fast-moving-consumer-goods markets, it is also of value in
the area of prescription medicines.
As was shown earlier with the ELM (Figure 1), prescription medicine consumers are, by
their very nature, highly involved in decisions about their healthcare. Indeed research
indicates that consumers who are health conscious or hold strong health beliefs are likely
to use active communication channels, such as interpersonal communication, print
32
DTCA from a Consumer Perspective
readership and the internet, as primary sources of health information (Dutta-Bergman
2004 ), while those individuals that are not particularly health-oriented are more likely to
utilise passive communication channels such as television and radio. To achieve synergy,
and speak with one voice, an IMC approach suggests that different elements of the
marketing communications mix are selected and used to deliver the same message via
different media. There are five major traditional advertising media (Shimp 2003); out-ofhome, newspaper, magazine, radio and television with internet advertising emerging as a
sixth option. Whilst all of these are viable options for DTC advertisers, the most popular
are the television, print and internet media.
i)
Television
In terms of reach, it is estimated that each American is exposed to more than 30 hours of
DTC advertisements each year (Brownfield et al. 2004), whilst women and older viewers
appear to be the audience most likely to be targeted by DTC advertisements, and this is
not surprising as female and older consumers tend to be more involved in healthcare
issues (Kahn 2001). When it comes to frequency, whilst OTC advertisements were more
frequent in nature, the duration of DTCA communications tended to be significantly
longer (Brownfield et al. 2004).
ii)
Print
DTCA inducements and appeals in consumer magazines serve several functions. First, to
motivate patients to request prescription medications viewed, and second to provide
consumers with arguments to seek compliance by medical practitioners with regard to
requests (Welch and Young 2004). Convenience, innovativeness, symptom control and
effectiveness were identified as the most frequent appeals used within magazines (Wilkes
et al. 2000). Furthermore inducements took the form of patient support, information and
financial inducements (Wilkes et al. 2000).
The majority of advertisements within
consumer magazines are targeted at potential users, rather than to third party influencers
such as families of the sufferer (or other consumers) (Bell et al. 2000). Where allowed,
most DTC advertisements in magazines named the drug and described its therapeutic use,
safety and effectiveness (Wilkes et al.2000).
33
DTCA from a Consumer Perspective
iii)
Internet
Around the world both consumers and advertisers are embracing the internet. Many
studies have attempted to determine the demographic profile of the internet user, however
whilst early commentators suggested that the typical user was tertiary qualified, male,
aged 20-44, with an average income twice as high as the national average (Australian
Bureau of Statistics 1998), this profile is now changing. Women, for example, are now
almost on a par with their internet use (55%), compared to men (60%) (National Statistics
Online 2004).
It is estimated that America alone had 200 million online consumers contributing to the
US$120 billion spent online in that country in 2004 (Anon. 2004). In terms of DTCA,
the internet is often used as part of a company’s promotional mix, its IMC.
Advertisements are placed on television or in print media with a direction to a website for
further information and, given that 80% of internet use is for information searching for
goods and services (National Statistics Online 2004), this seems to assist both the
consumer and advertiser.
Research conducted by Hicks, Wolgalter and Vigilante (2005) indicates that consumers
have a favourable attitude towards prescription manufacturers’ websites as sources of
drug information. It is important to recognise, however, that while consumers may in
fact prefer this medium, risk information can be difficult to access via this medium
(Hicks et al. 2005). Further, when studying websites in relation to the content within, it
was found that advertising appeals employed are similar to those found in print ads but
included more monetary incentives and a higher degree of medical and drug information
(Macias and Stavchansky 2003/4).
Chang and Thorson (2004) suggest that the adoption of integrated marketing
communications through the creation of television-internet synergy results in higher
attention rates and message credibility as opposed to the use of repetitive message
formats alone. Furthermore, brand attitudes developed under synergistic (television34
DTCA from a Consumer Perspective
internet) conditions are likely to have been formed under the central processing route of
the ELM, while the peripheral route to attitude formation is likely to be evoked under
repetitious conditions (Chang and Thorson 2004).
Whilst these three media represent those most often used by pharmaceutical companies in
their IMCs, the overriding promotional element is that of personal selling, or detailing
(personal selling by pharmaceutical representatives), and this activity is the largest part of
the mix. Fill’s (1998) model (Figure 2) depicts this balance in the IMC, linking it to the
purchase process. Advertising is used to gain awareness and induce action (trial) and
then becomes less important in the purchase process but is useful to use post-purchase to
confirm the wisdom of choice, or in the case of DTCA it can be a reminder to continue
medication. Personal selling or detailing, on the other hand, has an enduring role to play
throughout.
35
DTCA from a Consumer Perspective
Figure 2 – Relative Effectiveness of the IMC Mix
High
Public Relations
E
f
f
e
c
t
i
v
e
n
e
s
Advertising
Direct Marketing
Sales Promotion
Personal Selling
Low
Awareness
Knowledge/
Comprehension
Trial
Purchase
Post-Purchase
(Source: Adapted from Fill 1998, p. 10)
3.5.
Message Arguments – Risks and Benefits
It is a common misconception amongst consumers that only safe drugs are advertised
(Wilkes, Bell and Kravitz 2000). Americans, for example, believe that ads would not be
permitted in the media unless the FDA had found the drugs to be safe, and half the
sample surveyed was under the impression that all DTCA requires government approval.
A different angle is taken by Calfee (2002), however, who provides evidence to indicate
that advertising is viewed by a large proportion of consumers as the least-trusted source
of information and, as such, this acts as a balancing mechanism. Others (Lexchin and
Mintzes 2002), however, disagree, arguing that advertising is inherently pervasive in
nature and should not be underestimated in its power; in other words an argument for
responsible control of DTCA.
36
DTCA from a Consumer Perspective
In terms of constructing the message, or argument, in an advertisement, where the
purchase is high involvement with the consumer taking the central route to persuasion
through the ELM (Figure 1), the message argument is very important. Many messages
merely present one or more positive attributes about the product, or give reasons to buy
it. In the pharmaceutical area, with DTCA, a two-sided argument (Solomon 1996) is not
only more effective but also required in regulatory terms. In other words DTCA presents
both positive and negative information to assist the consumer in the decision making
process. A two-sided strategy appears to be the most effective when the audience is welleducated and not already loyal (Solomon 1996).
The disclosure or non-disclosure of risk information is one of the most debated aspects of
DTCA. FDA regulations allow manufacturers to avoid disclosure of all risks if they
provide adequate alternative information sources, and these typically take the form of
toll-free numbers and manufacturers’ websites (Huh and Cude 2004).
A content analysis of television prescription drug advertisements (Kaphingst et al. 2004)
found that consumers were given more time to consider benefits rather than risks on the
medium. Consequently it was concluded that the lack of adequate risk information
suggests that DTCA is far from educational in nature. It has been argued that the risk
information presented in DTCA is insufficient and lacks a fair balance between risks and
benefit information (Lexchin and Mintzes 2002). The authors cite the issuing of FDA
warnings as evidence that risk information is not being presented in a balanced fashion.
Furthermore, information that is presented is not always validated by scientific research.
A major intervening variable cited by several opponents of DTCA is that the language
contained within DTCA is often of a nature that is either confusing or not likely to be
understood by the vast majority of the public. In contrast, Calfee (2002) argues that there
is no evidence to indicate that DTCA is deceptive in nature, suggesting that consumers
are astute enough to recognise that the information presented in DTCA claims are biased
towards the advertiser.
37
DTCA from a Consumer Perspective
In terms of risk messages in DTC advertisements, it has been shown that a negatively
framed message is more likely to stimulate greater elaboration on the part of the receiver
(Homer and Yoon 1992) which should lead to a more informed choice. Calfee (2002),
however, reports that 40% of respondents indicated that they read half or more of the risk
disclosures, while 26% indicate that they read little of it. If the consumer was highly
involved in the purchase and intended to buy the medicine the vast majority (85%) were
likely to read almost all of the information (Calfee 2002), suggesting that they were
moving through the information gathering stages outlined by Moses (2000).
On the other hand, DTC advertisements that present balanced, two-sided arguments in the
form of risks and benefits are more likely to elicit positive responses from consumers as
they are less likely to engage in cognitive counter-arguments resulting in negative attitude
formation (Henderson and Hatfield 2001). As the debate continues it is apparent that,
specifically in the area of DTCA, advertisements that contained any warning information
were found to be more appealing than those that did not (Tucker and Smith 1987).
3.6.
The Doctor-Patient Relationship
The communication process in DTCA not only involves the advertising and personal
selling components, but also the role of the physician. In this context doctor’s act as a
gatekeeper for, without the support of the doctor, the individual is unable to obtain the
advertised product.
The consumer movement sought to empower consumers through knowledge and, to a
degree; this has been achieved in developed countries. The consumer is now more
sophisticated, more demanding and less tolerant; whereas once the word of doctors was
sacrosanct and the doctor-patient relationship more paternalistic than egalitarian, now a
healthy scepticism exists, especially in the field of public health. Shelton (2002) refers to
this as the emergence of the informed consumer. As consumers age they are more likely
to become conservative and demonstrate more loyalty towards their physician and
therefore less likely to be influenced by DTCA; the opposite, however, is true for
younger consumers (Gonul et al. 2000). Further, higher-educated consumers are more
38
DTCA from a Consumer Perspective
likely to trust their physician, compared to less-educated consumers, and therefore place
greater credence in the doctor-patient relationship (Gonul et al. 2000). As consumers
have changed and become more astute, doctors, too are more aware; for example,
physicians who are more experienced, those who see more patients, or those who have
had more exposure to pharmaceutical advertisements, are more accepting of DTCA of
prescription drugs (Gonul et al. 2000).
Thus, the doctor-patient relationship is in transition from one that was paternalistic in
nature to one which requires reciprocation on the part of both stakeholders (Coulter
1999). The suggestion being, that consumers recognise their own health requirements
and the development of a partnership with the physician will result in mutual benefits to
the doctor and the patient, supporting the notion of the educational benefits of
communication messages. Consumerism has finally arrived in the healthcare sector
(Calfee 2002), and the new ‘informed consumer’ (Shelton 2002) is seeking greater
involvement in healthcare decisions; as such, DTCA is seen as a mechanism which
allows this to occur (Eagle and Kitchen 2002).
Finally the doctor-patient relationship is not only concerned with new drug acquisition,
ongoing healthcare, perhaps with a program of medication is also part of the relationship.
In spite of well-conceived and well-executed post-prescription compliance programs,
overall adherence rates have remained at 50% for many years (Prounis 2005). In fact, the
National Council on Patient Information and Education reports that half of all patients
forget verbal information communicated by their physicians, while two-thirds are unable
to report precisely what they were advised to do (Prounis 2005).
In other words,
especially with an ageing population, this relationship must change if the communication
process is not to fail completely. There is an argument that, to this end, DTCA may in
fact be beneficial in the doctor-patient relationship, acting as a visual reminder thereby
assisting the doctor (Calfee 2002). Others (Mintzes, Barer, Kravitz, Bassett, Lexchin,
Kanzanjian, Evans, Pan and Marion 2003) do not agree, however, asserting that DTCA
acts as an intervening variable within the doctor-patient relationship, suggesting that
doctors are merely persuaded by consumers to prescribe a seen medication.
39
DTCA from a Consumer Perspective
3.7.
The Power of ‘Brands’
In general terms a brand is a ‘name, term, sign, symbol or design or a combination of
them, intended to identify the goods or services of one seller or group of sellers and to
differentiate them from those of competitors’ (American Marketing Association, cited in
Kotler and Keller 2006, p. 274). A brand is a product with features that differentiates it
from competing products designed to satisfy a similar consumer need. Brands identify
the maker of a product and allow consumers to link maker and product.
The main purpose of branding is to create some uniqueness in the product offer that is not
found in competing products. If consumers believe that there is no close substitute for
the branded product, the demand for the product becomes less elastic; in other words
consumers are less sensitive to price and will pay more for the unique features that the
brand possesses.
Brands can and do influence consumer behaviour. Brands can signal utility of the
product and also the quality level. Consumers learn to trust brands and brands facilitate
the buying process as the quality is assured and risk of the unknown is reduced (Kotler
and Keller 2006). At least this is the case in a ‘free market’. It has been suggested that
healthcare markets are not free in that the assumptions about consumers being informed,
being able to appreciate differences in quality, having bargaining power and free choice
about purchasing are violated. Health markets are distinguished from consumer markets
by ‘asymmetry of information and uncertainty in the definition, recognition, and
diagnosis of disease states’ (Conrad and Leiter 2004, p. 160).
In the healthcare market there has been robust debate over the past two decades about
whether DTCA has a market-expanding effect, that is, the ads inform consumers of new
treatment options and therefore generate new doctor visits, or whether DTCA has a
business-stealing effect whereby patients are persuaded to demand heavily advertised
brands.
40
DTCA from a Consumer Perspective
It has been established, in a rigorous study by Iizuka, that firms advertise more when
‘drugs are new, high quality, and when the untreated population is large’ and that DTCA
appeared to inform the existence of the treatment rather than to effect prescription choice’
(Iizuka 2004, p. 374). Further, another study demonstrated that DTCA of six therapeutic
classes had a significant effect on aggregate demand but did not affect market shares
within each class (Rosenthal, Berndt, Donohue, Frank, and Epstein 2002), and Iizuka and
Jin (2005) found that DTCA led to a significant increase in outpatient visits, but had no
effect on doctors’ specific choices among prescription drugs within a therapeutic class.
DTCA did not increase total market demand, or firms’ market shares for statin drugs in
the short run according to Calfee and colleagues (2002). However, there was some
evidence that TV advertising increased the proportion of high cholesterol patients who
had been successfully treated, suggesting that advertising reinforced compliance with
drug treatment and affected demand in the long run (Calfee et al. 2002).
In theoretical terms, our understanding of the DTCA process is enhanced by considering
how involved consumers are with the product, how they choose and evaluate market
offerings and how messages are interpreted and acted upon.
41
DTCA from a Consumer Perspective
4.
Consumer Protection and the New Social Regulation
In 1962, John F Kennedy championed consumers’ rights to safety, to be informed, to
choice, and to be heard (cited in Pope 1991, p. 55). Others have added the rights to
redress, education and a healthy environment to these basic rights (Lampman 1988,
Maynes 1988, cited in Pope 1991, p. 55). It is these documented civil liberties that have
underpinned the global consumer movement for many years and, indeed, inform the
fundamental purpose of industry and business regulation; to provide the consumer with
some measure of protection.
Significant social changes have influenced the evolution of social regulation, namely the
rise of the consumer movement, the environmental movement, and the women’s
movement (Ayres and Braithwaite 1992). Social regulation goes beyond the purely
economic nature of business regulatory activity, which merely attempts to regulate price,
entry and quantity of output, and introduces the concepts of regulation of quality of
output and nature of production processes (Pincus and Withers 1983). The regulation of
socially responsible behaviour, including marketing and all its facets, comes under the
auspices of social regulation. The regulation of advertising in general and of DTCA
prescription drugs in particular, is an example of social regulation in practice.
Both New Zealand and the United States of America, the only two countries where
DTCA is legal, have key pieces of legislation that underpin free speech and protect
consumer rights. The USA’s First Amendment to its constitution ensures protection of
commercial speech and New Zealand’s Bill of Rights Act 1990 similarly protects the
right to freedom of expression for all, including the two-way information process:
‘Everyone has the right to freedom of expression, including the freedom to seek, receive,
and impart information and opinions of any kind in any form.’
(Chen Palmer 2000, p. 16)
42
DTCA from a Consumer Perspective
The legislation in both countries has been tested in courts of law and has withstood close
scrutiny1.
Whilst some commentators have suggested that the legalisation of DTCA in the USA and
New Zealand was not anticipated (Hoek et al. 2004), given that both countries
demonstrate a high regard for freedom of speech and consumer empowerment, perhaps
the evolution of DTCA in both countries is not all that surprising.
4.1.
Regulatory Approaches and Options
When regulation of an industry is contemplated, the regulatory options are wide.
However, far from being a straightforward dichotomy between regulation and
deregulation, the alternatives include various options and these have been plotted on a
continuum, taking account of the degree of government involvement and autonomy of
individual firms (Garvin 1983). Figure 3 displays this regulatory spectrum.
1
For example, the landmark commercial speech case in the USA is Virginia State Board of Pharmacy v
Virginia Citizens Consumer Council 1976 (Vladeck 2004). See also Living Word Distributors Ltd v
Human Rights Action Group (Wellington) 2000.
43
DTCA from a Consumer Perspective
Figure 3 – The Regulatory Spectrum
Form of regulation
Unregulated industry
Degree of
Autonomy of
Government
Individual
Involvement
Firms
Low
High
High
Low
Pure self-regulation (no government intervention)
Self-regulation plus government provision of
technical information
Partial-industry regulation
Self-regulation plus government policing of
deceptive practices
Self-regulation plus government agency with rulemaking authority
Self-regulation embodied in Federal or State statutes
Decentralised systems of public regulation
Federal or State standard setting (for example
pollution)
. Government price and output setting (for example
public utilities)
(developed from Garvin 1983, p. 48)
According to this spectrum, the lower the degree of government involvement in an
industry, the higher the autonomy experienced by the individual firms.
It is those
strategies lying midway across the spectrum, representing mixed systems of various kinds
(such as ‘self-regulation plus government policing of deceptive practices’), that have
been most often overlooked in the debate over regulatory reform (Garvin 1983).
Whilst Garvin’s ten regulatory options are fairly comprehensive, some of his options are
also known by other terms, such as co-regulation, which is where the government plays a
role in the regulatory process, or regulated self-regulation where the government has a
44
DTCA from a Consumer Perspective
firmer say, or even power of veto, about who is involved in which regulatory processes.
The terms are used widely in different countries, different regimes and for different
purposes; however, it would appear that the level of government involvement differs
depending on the regime being studied.
A pyramid of enforcement strategies (Figure 4) is useful to analyse some of these options
in a broader sense. However, in practice, it should be noted that different organisations,
with different functions comprise the pyramid, there is not just one ‘self-regulatory
body’.
Figure 4 - Pyramid of Enforcement Strategies
Command
Regulation with
nondiscretionary
punishment
Command Regulation with
discretionary punishment
Enforced Self-Regulation
Self-Regulation
(Ayres and Braithwaite 1992, p. 39)
The pyramid depicts movement from self-regulation to enforced self-regulation, and then
from command regulation with discretionary punishment to command regulation with
nondiscretionary punishment. The top two levels of the pyramid are concerned with
45
DTCA from a Consumer Perspective
command, passing laws and putting in place measures to control the situation. The final
position, at the apex of the pyramid, has a military analogy according to the authors, in
the ‘burning of bridges’ (1992, p. 38). If the bridges that are an army’s only route of
retreat are burned, the enemy knows that it must fight a bloody battle if it advances
beyond a certain point. This act communicates to an enemy a commitment never to
surrender. Naturally, for business, this situation would be unworkable and the draconian
measures a hindrance to commerce.
An example of this theory is apparent in the
different ways DTCA is regulated in the two countries where it is allowed; in the USA
regulation is more centrally controlled than in New Zealand, where a mix of selfregulatory bodies, supported by statutory regulators is practised.
Escalation up this pyramid gives the state, or government, greater capacity to enforce
compliance but at the cost of increasingly inflexible and adversarial regulation with an
unhappy industry. Clear communication in advance of resolution by government to
climb the pyramid provides incentives to both the industry and regulatory agents to
ensure that regulation works at lower levels of interventionism.
The New Zealand
advertising industry has a history of pre-emptive compliance with impending government
interference in advertising self-regulation. For example, concerned that the government
was going to ban DTCA in New Zealand, in 2000 the industry transformed its
Therapeutic Advertising Advisory Service (TAAS) from a voluntary service into a
mandatory Therapeutic Advertising Pre-vetting Service (TAPS) (Hoek et al. 2004). This
pre-emptive move had a win-win effect for both the industry, which retained its selfregulatory status in terms of DTCA, and the public, as the proportion of complaints about
prescription drug advertising subsequently declined (Hoek et al. 2004).
For more than two decades there has been evidence of a worldwide increase in
advertising regulation (Boddewyn 1981) generally, and a swing towards advertising selfregulation in particular (Boddewyn 1988). Gupta and Lad (1983, p. 419) suggest that
effective industry self-regulation will only occur if the firms in the industry, the
advertisers, decide to cooperate with each other, for whatever reason.
46
DTCA from a Consumer Perspective
Benefits of advertising self-regulation basically comprise the ability to expedite the
process (usually around 6 weeks complaint turnaround), flexibility in dealing with new
types of media and the ability to observe the spirit as well as the letter of the Code
(Harker 2003). There are of course disadvantages and drawbacks to advertising selfregulation, including:
•
relatively few cases are handled by advertising self-regulatory bodies (and
statutory bodies) in proportion to the number of advertisements and the true extent
of advertising failures,
•
relatively little publicity is given to advertising self-regulatory standards and
decisions in many countries,
•
many advertising self-regulatory decisions come too late, after the infringing
advertisement has been discontinued,
•
advertising self-regulatory penalties are relatively mild, except for denial of
access to the major media,
•
inevitable bias in allowing industry members to judge their own members causes
concern over representation of the public interest.
(Boddewyn 1989; Blakeney 1986)
However, these drawbacks are valid only if advertising self-regulation is viewed as a
consumer-redress mechanism; on the other hand, if the true purpose of advertising selfregulation is viewed as improving and achieving higher standards of advertising, they are
irrelevant (Boddewyn 1989).
Boddewyn (1989) suggests that adopting this second
perspective means that we assume advertising self-regulation is not primarily about the
systematic invitation, collection and handling of complaints (p. 23), it is much more
concerned with improving advertising practitioner conduct rather than with satisfying
individual complainants, even though these two goals are compatible and related.
Boddewyn also makes the point that, if redress were the main goal of advertising selfregulation, then obviously ‘great speed would be essential, but deliberate speed is
sufficient for educational and consciousness-raising purposes’ (1989, p. 24). This is
supported by the premise that punishment is expensive, time-consuming and destructive,
47
DTCA from a Consumer Perspective
whilst persuasion is efficient in building trust and relationships that, through goodwill,
will deliver a similar outcome for society.
4.2.
Regulating DTCA in Practice
Regulation of DTCA in New Zealand is controlled by the Advertising Standards
Authority under its Code for Therapeutic Advertising which covers OTC and prescription
drug advertising. In addition, the Researched Medicines Industries Code of Practice sets
out 12 guiding principles regarding business and marketing conduct (Auton 2004). The
ASA code explicitly highlights the need for compliance with the Medicines Act and the
Medicines Regulations (Hoek and Gendall 2002).
Thus, whilst the self-regulatory
framework in New Zealand takes control of the system, it is complementary to the legal
regulatory framework in place (Harker 1998).
In the US the regulation of therapeutic drugs advertising is divided between the Federal
Trade Commission (FTC) and the Food and Drug Administration (FDA), both are
government bodies; the former handles OTC advertisements, the latter is concerned with
prescription medicine advertising (Hoek et al. 2004). The Pharmaceutical Research and
Manufacturers Association (PhRMA) is also involved in the system of regulation of
DTCA in the US but responsibility lies more with the FDA than the industry body.
Indeed, PhRMA recently (August 2005) published its ‘Guiding Principles’ on DTCA,
although close scrutiny shows that the principles are very much in line with the FDA
Code.
The key difference between the two approaches to regulation of DTCA is that in New
Zealand the self-regulatory body there encourages and handles complaints about
advertising, whilst in the USA the government body, the FDA, monitors advertising and
pursues offenders.
A seven-component framework of effective advertising self-regulation has been
discussed in the literature (Harker 2003) and, whilst the main purpose of this framework
is to analyse advertising self-regulatory bodies, a number of the components are useful in
48
DTCA from a Consumer Perspective
the context of DTCA specifically. Codes of conduct have been crafted in both countries
and created as suggested by Harker (2003), with involvement from all interested parties
such as consumer groups, government agencies (Wiggs 1992), consumers, industry, and
the legal profession (LaBarbera 1980). Both country codes are written in plain language
to allow for as much consistency in interpretation as possible (LaBarbera 1980) and are
clear and concise. Whilst Harker (2003) suggests that the regulatory body itself should
be audited regularly and rigorously, it is apparent that in both the USA and New Zealand
the DTCA codes themselves have been reviewed and amended as necessary and, in both
countries, the relevant industry body has ensured that its code mirrors or complements
statutory guidelines.
Industry compliance (Harker 1998) is very important to the success of any regulatory
regime, without compliance the organisation is impotent. It has been suggested that there
must be a link between compliance and sanctions (Buckley 2004) in other words, to
achieve compliance punishment must be enacted, however some would argue that
persuasion is more important in terms of building relationships for the future, using
education as the key. Punishment, in the form of sanctions, in self-regulatory regimes
range on a continuum from education to financial incentives to comply and, historically,
different schemes in different countries have varying levels of success.
Where the
scheme incorporates a national tripartite system (Boddewyn 1992, Sinclair 1992) and the
advertisers, agencies and media are involved in the process, the chance of compliance
with decisions is greatly enhanced. Whilst the US system has the weight of the law
behind it and thus no problems with compliance, the New Zealand system has achieved
100% voluntary compliance for many years (Hoek et al. 2004).
Perhaps the key to regulatory effectiveness is to concentrate on building a regulatory
system, either industry or government controlled, that forges sound links between
regulators and advertisers; indeed, the ‘regulator-as-consultant’ concept (Kagan and
Scholz 1984).
49
DTCA from a Consumer Perspective
Debate has raged for a number of years in the area of industry regulation and specifically
advertising self-regulation, and no doubt it will continue for many years to come. The
underlying objective of regulation, and self-regulation in particular, however is to ensure
compliance with accepted norms of conduct, with a view to protecting the consumer.
With the different approaches to regulation of DTCA currently established in the USA
and New Zealand a prime opportunity exists to compare both on their merits.
In summary, there are a number of regulatory options for a market when there is a need to
regulate. In the advertising context, there is a continuum from complete government
involvement to industry self-regulation and the United States of America and New
Zealand approaches are located at different places along this continuum. Each model has
its merits and challenges; however a closer exchange of views may assist both countries
in their regulatory efforts in relation to DTCA. Finally, there are a number of consumer
rights, one of which is to knowledge, which leads to empowerment; however, with this
privilege comes the need for protection and this is the role of regulation.
50
DTCA from a Consumer Perspective
Part 2 The Practice
Introduction
A number of studies interrogated in this review provided answers to the question of the
nature and extent of DTCA and consumer benefits and risks. But what is good quality
evidence? According to the Australian Consumers’ Association sound studies should
comprise, as a minimum,
•
large samples of target groups
•
have a control group
•
be double blind experiments
•
random allocation to control and test groups
•
statistical analysis and results should be reported in quality, peer reviewed
journals
•
multiple studies supporting the outcome are needed – not just one (‘Choice’
2006).
Only five studies were located that addressed the question of the impact of DTCA on the
consumer. Three studies (Basra 1996, Zachry et al. 2002, Jong et al. 2004) explored the
increase in advertising for prescription medicines as a result of DTCA and two studies
investigated the prescribing behaviour of physicians in response to DTCA (causal
research) (Mintzes et al. 2003, Kravitz et al. 2005). This section reviews the key studies
on DTCA and the consumer.
5.
The Industry
World expenditure on general healthcare is in excess of US$3,000 billion. The world
market for pharmaceutical medicines is worth over US$400 billion per annum and the
United States of America accounts for over 50% of world sales (Europe for 22%). US
51
DTCA from a Consumer Perspective
companies spend over US$30 billion on Research and Development (R&D) (IMS Health
2003).
The pharmaceutical industry spends over US$900 million to bring a ‘block buster’ drug
to the market and the development time is more than eight years. R and D spend
represents over 33% of sales value and the payback period for a new drug is less than ten
years (EFPIA 2001). The US prescription drugs market is worth around US$220 billion.
In 2003, US Pharmaceutical Companies spent around $25 billion on promotions, more
than 85% of which was on traditional marketing methods, for example sampling,
detailing, whilst 15% was spent on DTCA, or US$4 billion in 2004; 90% of this spend
was devoted to promotion on TV (Arnold 2005, Elliot 2004, United States General
Accounting Office (USGAO) 2002, IMS 2004).
Whilst figures for the New Zealand market specifically are sparse, it is estimated that
around NZ$80 million dollars was spent on the advertising of all health products in New
Zealand in 2002 and less than NZ$10 million was spent on prescription medicines. Also,
prescribing levels in New Zealand were found to be lower than those in the United States
(Eagle and Chamberlain 2003).
American consumers purchase over 2.5 billion prescriptions per year, averaging 9
prescriptions per consumer (Cohen, McCubbin, Collin and Perodeu 2001). In the United
States the demand for prescription drugs increases significantly with age; by the age of 45
years more than half of all adults are using at least one prescription drug, and by the age
of 55 years almost one-quarter are taking four or more of these drugs (Prevention 2004).
In New Zealand, on the other hand, 46% of the population take a prescription medicine
every day.
Worldwide, the top twenty drugs account for around 58% of DTCA
expenditure (Rosenthal et al. 2002).
Significantly, drug companies appear to be unsure of the impact of DTCA with twentythree ad campaigns for prescription medicines being curtailed or modified in a six-month
period (Findlay 2001). Further Pfizer, the world’s largest pharmaceutical marketer, has
52
DTCA from a Consumer Perspective
announced its intention to reduce traditional DTCA spending in its US$1 billion
promotion budget, and concentrate more on the patient-doctor link; detailing (Thomaselli
2005).
Two Kinds of Products
Pharmaceutical companies, in the broadest sense, inform, promote and sell products
direct to consumers, known as self-medication or OTC preparations. More advanced and
technically complex drugs (ethical drugs or Rx) are supplied through a doctor by a
prescription. All prescription medicines carry some risk for human beings. Drugs for
humans have been developed to affect the physiology of man and woman and are made
to diagnose, cure, mitigate, treat, or prevent disease in humans (Vogt 2005). It has been
said to the Pharmaceutical industry by the FDA that:
‘… your drugs are dangerous, even when taken as directed.’
Prescription drugs are an important part of a complex system of medical care that must be
ruled first and foremost by science and careful human judgement (Meek 2001, p. 3).
In the United States of America and New Zealand, DTCA of prescription medicines is
permitted. The history of the adoption of DTCA in these countries is well recorded in the
literature and is beyond the scope of this paper – see for example, Auton 2004, Hoek et
al. 2004, Eagle and Chamberlain 2004.
53
DTCA from a Consumer Perspective
6.
The Consumer – Changing Markets, Changing Consumers
The consumer is changing. In developed countries populations are ageing are bettereducated, more affluent, and women are enjoying greater economic freedom. ‘Baby
boomers’, people born between 1946 and 1964, dominate most developed markets
representing almost 80 million consumers in the United States alone. Also, the group of
people over 40 years of age will be 60% larger than the 18-39 age group by 2010, and the
40+ years group now control 75% of the country’s wealth.
Thirty-six percent of
‘boomers’ talk to doctors about advertised medicines, compared to 27% for ‘matures’
(people born before 1945) (Prevention 2004). Americans spend 2.6% of Gross Domestic
Product on medicines, compared to 1.2% in the UK (Auton 2004).
The ‘Boomers’ display different attitudes, opinions, values and behaviours to their
predecessors who seemed to have placed greater trust in the words and deeds of
politicians, lawyers, teachers, doctors and priests, and they are ‘more assertive, less
deferential and more demanding patient-consumers’ (Meek 2001).
Consumer Needs
The ‘buying process’ commences with the recognition of a need; a need for good health.
Needs vary by individual; some consumers who are critically ill have a strong need for a
cure, other consumers have needs of which they are not fully aware. It has been shown
that women have a stronger need for prescription drugs than men. Women use more
medications than men in the USA, Canada, Europe and Australia, even after adjusting for
birth control and hormone therapy. Consumers of medicines are generally older, in more
pain, in poorer health, and more stressed and depressed than other sections of society
(Neutel and Walop 2005). From a marketing point of view, it is often strategically
beneficial to group consumers into segments based on similar needs and benefits.
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DTCA from a Consumer Perspective
Interestingly, the Prevention survey segments this market by ‘generational age’, that is
‘Generation Y’, ‘Generation X’, ‘Boomers’ and ‘Matures’. Table 1 shows the population
numbers for these groups.
Table 1 – Segmentation of the US Prescription Medicine Market
Segment
Definition – birth date
Number of Members
Matures
Before 1945
52 million
Baby Boomers
1946-64
80 million
Generation X
1965-1981
57 million
Generation Y
1982-1994
60 million
Millennialls
1995-2002
42 million
(Source: Shimp 2003, Prevention 2004, Kotler and Keller 2006)
Another large study segments the market according to the state of health of the consumer
(White, Draves, Soong and Moore 2004). From a sample of 21,000 American adults,
White et al. identify 4 broad consumer segments. The largest segment is the healthy half
– 50.8% of Americans with no obvious health problems. Next, at 28.2% (60 million
consumers), come the ‘Doctor led’ segment who have lifestyle restricting conditions and
do what the doctor advises; the ‘self managers’ at 12.7% (27 million) are the group that
have occasional/seasonal conditions and who ‘self-treat’ with OTC formulations, and
finally there are the ‘solution seekers’ at 8.3% (18 million) who have lifestyle restricting
conditions and who proactively seek new solutions.
These segments have been
confirmed in three studies. White et al. conclude that ‘responsiveness to advertising
varies profoundly with the condition at issue’ (2004, p. 66), and in terms of patient care
‘our data show that American doctor-patient relationships are substantially unaffected by
drug marketers’ multi-billion investments in consumer promotion since 1997’ (2004, p.
66).
55
DTCA from a Consumer Perspective
7.
DTCA and Regulation – The Practice
7.1.
DTCA Regulation
DTCA is regulated in the United States by the FDA and in New Zealand by the
Advertising Standards Authority (ASA).
Legislation and guidelines determine the
content of DTC advertisements (Hoek et al. 2004). In the US:
•
drug ads cannot be false or misleading,
•
there has to be a ‘fair balance’ in the presentation of benefits and risks,
•
print ads must include brief summary information about contraindications and
side-effects,
•
broadcast ads that are product specific must include a ‘major statement’ of chief
adverse effects and contraindications,
•
the ‘adequate provision’ requirement can be met by referring consumers to
doctors or pharmacists and to a website, a toll-free number, or a concurrently
running DTC print ad,
•
consumer friendly language should be used.
An estimated 6,000 pieces of promotional material aimed at consumers was submitted to
the FDA for approval in 2002, including 486 broadcast ads, and just 14 staff were
employed to monitor the ads worth US$3 billion (Kaphingst and Dejong 2004). The
Public Citizens Research Group found 90 cases in three years where ads had violated
FDA rules or Federal Laws but Pharmaceutical firms have been willing to drop or amend
errant ads (Calfee 2002).
In New Zealand, all prescription drug ads must comply with the Medicines Act 1981 and
the Medicine Regulations 1984. Compliance monitoring is the responsibility of Medsafe,
a division of the Ministry of Health, and industry self-regulation through the ASA and
RMI. In 1996 the ASA introduced the Code of Therapeutic Advertising which covered
all products for which therapeutic claims were made and which required advertisements
to comply with appropriate statutes and be truthful, socially responsible and not
56
DTCA from a Consumer Perspective
misleading or deceptive. Further, consumers must be told if the drug is a prescription
medicine and whether there is a charge for the drug; an instruction to ‘use strictly as
directed’ is mandatory under the code. Advertisements have to be pre-vetted under the
Therapeutic Advertising Pre-Vetting Service in order that the ads comply with legal and
code requirements (Meek 2001).
Violations against the code are dealt with by a
Complaints Board that achieves 100% compliance because the media refuses to accept
any advertisement that the Board has ruled errant in any way (Hoek et al. 2004).
7.2.
DTCA in New Zealand
The information on DTCA in New Zealand is sparse and research of rigour has been
restricted to a few notable scholars who are referenced in this report. The high awareness
levels of DTCA in New Zealand tend to mirror those found in the United States (Eagle
and Chamberlain 2004). Television is the most highly recalled medium of DTCA in New
Zealand at 98%, followed by magazine (60%), newspaper (41%), radio (37%) and
internet (9%) (Hoek et al. 2004). Over 40% of Wellington (New Zealand) residents have
searched the internet for health information (Scott, Scott and Auld 2005).
With regard to benefit and risk information in the ads shown, respondents in both
countries in the range 80-90% were able to recall benefit information. There was a
marked difference in the recall of risk information, however, with recall levels typically
reaching 80%+ in the US, but less than 30% in New Zealand. Hoek and colleagues
ascribe this difference to lack of ‘balance’ in New Zealand ads (2004, p. 239).
As in the United States, a high proportion of the population in New Zealand (46%) take a
prescription medicine every day, but doctors did not feel pressured into prescribing
advertised medications.
However some New Zealand doctors felt that ads for
prescription medicines did not give enough information about the risks and negative
effects of using the medication, and over 66% of consumers admitted to reading most or
all the information that was presented. There was a high level of satisfaction for patients
with doctors’ explanations for a treatment strategy (Eagle and Chamberlain 2003).
57
DTCA from a Consumer Perspective
Respondents in both countries were firmly of the opinion that DTCA increased consumer
awareness of new drug treatments and that DTCA facilitated patient-doctor discussions.
The New Zealand research indicated that a ‘great majority of patients neither asked for,
nor received, a prescription as a result of DTCA’ (Hoek et al. 2004, p. 244) and that
doctors often recommended alternative treatments or lifestyle changes in response to
specific drug requests.
Research in the United States and New Zealand indicates that there are few problems
with DTCA. It is the view of Hoek, Gendall and Calfee that DTCA is moderated by
‘innate market forces such as consumer scepticism, doctors’ roles as gatekeepers and the
desire of manufacturers to maintain goodwill’ with both doctors and patients. Finally, the
surveys suggest that consumers themselves do not share many of the concerns raised on
their behalf (2004, p. 246).
7.3.
DTCA in Australia
DTCA is not allowed in Australia under the Therapeutic Goods Act and there is a dearth
of studies that have employed rigorous research methods and provided soundly based
evidence on DTCA and disease awareness campaigns and their impact on the consumer.
According to Healthy Skepticism AUS$1-$1.5 billion is spent on drug promotion in
Australia annually (Mansfield 2003).
The Australian Consumers Association looked at the subject from a consumer
perspective and found that medical advertising was proliferating in the Australian media
maintaining that ‘Pharmaceutical companies are finding sneaky, but effective, ways of
getting around the laws’ that prevent DTCA to the public. This takes the form of
campaigns that mention diseases and treatments but omit brand or manufacturer and
advises the consumer to ‘ask your doctor’ (Australian Consumers Association 2004, The
‘Australian’ and Pfizer ad 2006, p. 3). Other methods that have been used to get ‘around
the rules banning advertising’ have been:
58
DTCA from a Consumer Perspective
•
Medical breakthroughs in the media, or ‘drug plugs’, where ‘new’ drugs that may
not be new have been the subject of news stories, people have seen the story and
have asked their doctor for the drug.
•
The creation or funding of high profile support groups by the drug companies, for
example the ‘Healthy Weight Task Force’ sponsored by Roche the makers of
Xenical.
•
The use of the ‘expert opinion’ where experts have been paid to present their
opinions to the media; for example when a study suggested that HRT may
increase the risk of breast cancer, experts were brought forward to allay the fears
of women.
•
Sponsoring of journalists by drug companies.
•
‘Pop culture’ has helped the spread of diseases and cures, for example Viagra.
(ACA 2004)
The Australian Consumers Association has stated that its concerns about DTCA have
been based on experiences in the US and New Zealand:
•
Pressure on the Pharmaceutical Benefits Scheme (PBS). ‘People demand more
medications’ with DTCA; for example, campaigns about depression have been
partly responsible for the increase in PBS costs for antidepressants from around
AUS$25 million to over AUS$300 million in 10 years.
•
Over-medicalising normal conditions, also called ‘disease mongering’, for
example erectile dysfunction may be due to relationship problems, stress, alcohol
or other health issues.
•
Balanced information has not been provided by the drug companies, for example
the New Zealand Consumers’ Institute had three media ads assessed by experts
and none presented a balanced picture; a US survey showed that drug ads tended
to use emotional appeals rather than the ‘hard facts’.
•
Those reporting the story may not present the full picture.
•
Dangers of self-medication; consumers can get drugs online from less than
reputable online pharmacies.
(ACA 2004)
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DTCA from a Consumer Perspective
On the role of doctors, the ACA felt that a beneficial impact for the consumer has been
that DTCA has encouraged people to discuss their condition with their doctor. However
the ACA cited doctor surveys that demonstrated that DTCA had an ‘overwhelming’
negative impact on doctor-patient relationships, and 12 British doctors admitted to
prescribing treatments that they knew were ineffective. Finally, the ACA reviewed the
regulation of medicine marketing in Australia which is administered by Medicines
Australia, a pharmaceutical industry body.
The ACA questioned whether the
pharmaceutical industry should regulate itself but found that Medicines Australia was
‘doing its job’ even though it met behind closed doors and failed to report all cases (ACA
2004).
7.4.
Australia and New Zealand – Trans-Tasman Harmonisation
On 10th December 2003, government representatives from Australia and New Zealand
signed a treaty to regulate medicines and therapeutic products (Therapeutic Goods
Administration (TGA) 2003). In effect the treaty means that the Trans-Tasman countries
agreed to harmonise the legislation governing the authorisation, administration and
promotion of medicines in both countries. The existing regulators, the TGA in Australia
and Medsafe in New Zealand, will be replaced by a Trans-Tasman Joint Agency, and the
proposed commencement date is July 2006.
The Interim Advertising Council was established to oversee this process of change and it
comprised representatives from government, the medicine and advertising industries,
consumers, and doctors’ organizations, with an independent Chairman.
One of the
challenges for the Council was to blend the two traditional models of advertising
regulation in both countries; Australia had a system of co-regulation and New Zealand
had a system of self-regulation. There are a number of papers on the TGA website
(www.tga.gov.au) which provide details of the proposed regime; the key paper
concerning the proposed arrangements for advertising is entitled ‘Key Aspects of a
Trans-Tasman Model for the Regulation of the Advertising of Therapeutic Products’.
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DTCA from a Consumer Perspective
The draft Therapeutic Goods Advertising Code 2005 has been agreed and is due for
implementation in July 2006, subject to legislation.
The code will apply to the
advertising of prescription medicines, over-the-counter medicines and complementary
medicines and, although DTCA is not permitted in Australia, there is de facto advertising,
termed disease awareness advertising, to which the code will apply.
In summary, this single Code has the force of law in both Trans-Tasman countries. The
existing pre-vetting systems in both countries for DTCA will continue but will be
enhanced, especially in Australia.
There will be mutual recognition of pre-vetted
advertisements, therefore an advertisement once pre-vetted may be published or
broadcast in either country.
In terms of complaints about unacceptable advertising, in New Zealand these will
continue to be heard by the Advertising Standards Complaints Board and will therefore
continue as a self-regulatory model. In Australia, however, a new complaints board will
be established which will be a co-regulatory model. There will be mutual recognition of
decisions by both boards; therefore if a complaint is upheld then the decision applies in
both countries. The Australian Board will have punitive powers but the New Zealand
Board will not; however the New Zealand Ministry of Health will have punitive powers
to back up Board decisions if necessary.
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DTCA from a Consumer Perspective
8.
Educating Consumers and Patients
The World Health Organization (1978) states:
The people have the right and duty to participate individually and collectively in the
planning and implementation of their healthcare.
The healthcare market is divided basically into two segments, the healthy half and the
unhealthy half (White et al. 2004); segments that comprise different people with different
needs. According to White et al., DTC ads are ‘invisible’ to the healthy half because they
have no obvious health problems (2004, p. 63). This is not necessarily the case because,
as will be shown, some of these people have health problems of which they are unaware,
and they may need to be alerted to them. Likewise the ‘unhealthy’ half has a need to be
informed about new research findings and new treatments. There is a danger, it is
claimed, that DTCA results in the ‘medicalisation’ of normal conditions, and this in turn
leads to a large increase in expenditure on pharmaceuticals by individuals, health funds
and governments (Mintzes 2001). DTCA allows pharmaceutical companies to inform
and educate consumers about disease states and the range of options open to them.
According to the US Government Healthcare Commission:
‘Well informed consumers are the bedrock of an efficiently operating market. Without
meaningful information, consumers are more likely to make choices that can result in less
than optimal outcomes for themselves and there is less incentive for participants to strive
for excellence.’
(Presidents’ Advisory Healthcare Quality Commission 1998)
There are a number of medical conditions of which people are unaware, which go
untreated, or existing conditions that are ‘under-treated’.
Colin Meek, in his well-
researched report for the Royal Pharmaceutical Society of Great Britain (2001),
highlights some of these under treatments:
•
One third of the 16 million Americans who suffer from diabetes have not yet had
the disease diagnosed.
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DTCA from a Consumer Perspective
•
56 million Americans have high blood pressure – 18 million are unaware of it, 8
million know that they have this killing disease but are not receiving medication
for it.
•
Only half the people who could be helped by a Beta blocker following myocardial
infarction were prescribed the medicine – when beta-blockers are associated with
a 14% lower risk of mortality at one year after discharge.
And the ‘unmentionable’ conditions that consumers deny the existence of, or feel that ‘it
only happens to me’, for example:
•
The marketing campaign for Proscar, the drug from Merck and Co. that tackles
prostate problems, used broadcast, print, internet advertising and a toll-free
number to inform and educate men over 50 about the condition, about Proscar and
what the drug does.
•
The marketing campaign for Detrol sought to ‘legitimise’ urinary incontinence
through DTCA and doctor messages, and to raise awareness about the condition
and a treatment. Doctor visits for urinary incontinence increased from 1.8 million
to 2.6 million during the campaign.
•
And a campaign was mounted for a treatment for genital herpes, thought to be
affecting more than 45 million US citizens. In a survey of patients responding to
a toll-free number almost 45% said that they had visited a doctor to discuss the
ailment within three months of the ad campaign.
(Meek 2001)
In another study reported by Ernst Berndt, about 25% of doctor visits in which the patient
asked about a DTCA prescription drug resulted in the discovery of a new condition
including hypertension, diseases of the oesophagus, duodenum and stomach, and high
cholesterol. Almost 43% of the new diagnoses were ‘high priority conditions’ (Berndt
2005). Statin cholesterol lowering drugs typically reduce the incidence of fatal and non
fatal heart attacks by 20-30%, and also reduce the risk of strokes (Calfee et al. 2002). A
study in the UK, of some 20,000 patients, demonstrated the benefits of Simvastatin
treatment in low risk heart disease. The study indicated that 15 million people in the UK
63
DTCA from a Consumer Perspective
should be receiving the medication when in reality only 1 million had prescriptions for
the drug (Auton 2004).
Osteoporosis is another condition that seems to be overlooked, undiagnosed and undertreated. Some 50% of women over 50 years of age experience osteoporosis-linked bone
fracture yet only 14% of women of that age expect to develop the disease in their
lifetime.
Finally, the FDA Physicians survey confirmed that DTCA, when done correctly, can
serve positive public health functions such as increasing patient awareness of diseases
that can be treated, and prompting thoughtful discussions with physicians that result in
needed treatments being prescribed (Aikin, Swasey and Braman 2004). The economists
considered that DTCA of prescription drugs had three possible effects and they
confirmed the ‘public good effect’ whereby the consumer was provided with information
regarding symptoms and treatments irrespective of whether the consumer bought the
product.
Secondly, the ‘matching effect’ was identified whereby the advertisement
provided important information regarding side-effects, contraindications and facilitated a
patient-doctor discussion where treatment regimes would be ‘matched’. Thirdly, the
‘branding’ effect was identified whereby the patient demanded the drug because of
persuasive or aesthetic characteristics or reputation of the drug, irrespective of the
efficacy of the drug (Bradford, Kleit, Nietert, Ornstein 2005).
The ‘consumer welfare’ effect of DTCA whereby advertising provides information to the
consumer that taps unmet needs has been confirmed by a number of robust findings from
recent studies and reported by Berndt (2005, p. 15). DTCA appears to increase market
size rather than market shares, and when:
‘advertising increases the size of the overall market but does not affect any particular
product’s market share, then advertising is likely to enhance consumer welfare.’
(2005, p. 14)
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DTCA from a Consumer Perspective
There is a significant research output demonstrating that advertising improves markets by
providing consumers with important information that they would otherwise ignore and of
which they would remain ignorant, or fail to receive or receive too late (Calfee 2002). It
has also been argued for many years that consumers need more information about drugs
and treatments and that they tend to be proactive when seeking this information (Kopp
and Bang 2000). The last five decades or so have seen a rapidly expanding role for drug
therapy in medical practice and, as has been demonstrated above, these years have
witnessed a powerful trend of greater consumer involvement in healthcare.
About half of consumers who recalled seeing DTC ads indicated that the messages
received sometimes prompted them to seek further information (Weissman, Blumenthal,
Silk, Zapert, Newman and Leitmann 2003). Table 2 displays the sources of further
information utilised by viewers of DTCA.
Table 2 – Sources of Further Information
Information Source
%
Own doctor
80
Family and friends
57
Pharmacists
53
Nurses
48
Brochures in doctors’ offices
47
Medical journals
42
Internet
38
Newspaper articles and ads
33
Another doctor
22
(Source: from Calfee 2002, White et al. 2004)
The ‘doctor is still king’ (Buckley 2004). But what about the degree of trust in these
sources by consumers?
Advertisements were least trusted (48%), followed by
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DTCA from a Consumer Perspective
family/friends (61%), government agencies 80% and doctors (95%); doctors are a highly
credible source of information.
Consumers have been found to be suspicious of advertising. Reviewing six decades of
empirical data with regard to consumer beliefs and attitudes towards advertising, Calfee
and Ringold (1994) found that although consumers believed that advertising was less
than economical with the truth, they generally found that the benefits of advertising
outweighed its drawbacks. Although around 70% of consumers complain about certain
aspects of advertising, it seems that this cannot be generalised to DTCA since a large
majority of consumers have found DTC ads provide useful information and assist them in
discussions with their doctors (Calfee 2002, Baukus 2004). Older consumers, however,
thought that ads were largely responsible for the increased cost of prescription drugs and
found the ads confusing (ORC 2002). Barbara Bertner of Ipsos-Insight Pharm Trends
found that almost 2 in 10 consumers took action as a result of a DTC advertisement in
2005 and 1 in 10 requested a specific medication. She adds that:
‘Americans, despite finding prescription drug advertising annoying, believe that
manufacturers should be able to advertise as advertising provides a good source of
information for alternative therapies. Manufacturers are taking notice with a distinct
change in creative style that is more serious in tone and presents the information in a
more straightforward manner.’
(Bertner 2005, p. 2)
Significantly, another important study demonstrated that increases in DTCA shortened
the time between diagnosis and drug use for osteoarthritis (Bradford et al. 2005). In the
final analysis, a large majority of adults (61%) in a large national survey in the United
States disagreed with the statement that:
‘Ads for medications should only be in medical magazines for doctors.’
(ORC 2002, p. 7)
It seems that consumers have a need to be kept informed.
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DTCA from a Consumer Perspective
9.
Consumer Reaction to DTCA – The Practice
Today over 50% of Americans take prescription drugs and 54% of mature Americans
aged over 55 years have a chronic condition for which they take increasing amounts of
medication (Moschis et al. 2000). The majority of US drug users (78%) say that the
drugs have a positive impact on the health and quality of life of US citizens. Further,
most Americans (80%) feel confident about the safety of prescription drugs sold in the
United States (Kaiser 2005).
Consumers have a need for information. In this information-rich environment consumers
have access to many sources of data in connection with their healthcare needs. One of
these sources is communication from drug companies which use the mass media or
DTCA.
Consumer reaction to DTCA in the United States is a key aim of the Prevention
magazine annual survey of US citizens. The tracking survey provides sound evidence of
consumer reaction to DTCA as it interrogates a large sample of the US population
(1,500), with a sampling error of plus or minus 3%, and has done so for seven years.
The survey represents the one data source that tracks attitudes and some behaviours over
time. The latest survey shows that 96% of adult US citizens, or 195 million consumers,
are aware of advertised medicines and the ability to match medicines with conditions has
improved over time (Prevention 2004).
The survey also shows that 32% of consumers who have seen a DTC ad spoke to their
doctors about an advertised medicine and of these consumers around one in four asked
for a prescription for the advertised medicine.
These proportions have remained
unchanged for the past 7 years. The number of prescriptions issued to those patients who
asked for an advertised medicine, around 7% of the sample, is increasing at about 3% per
annum. The majority of consumers recall the benefits and risks of medications in the ads
but feel that this information could be presented more clearly. This could be one of the
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DTCA from a Consumer Perspective
reasons for consumers to make such good use of the media-related sources required in
broadcast ads by the FDA, for example toll-free numbers, the internet and magazine ads;
indeed, magazine ads are an important source of additional information for over 50% of
consumers (Prevention 2004).
These finding are largely confirmed by the FDA surveys undertaken in 1999 and 2002
and reported by Aikin, Swasey and Braman (2004). Recall of DTC ads on TV was
reported by 97% of the sample in 2002 (94% in 1999). Significantly, the number of
people who saw ads on the internet increased from 9% in 1999 to 16% in 2002, and those
seeking additional information on the internet as a result of an ad increased from 18% to
38% between the two surveys (and to 57% in the 2003/4 Prevention survey).
By
contrast, 51% of consumers sought additional information from a Pharmacist and 89%
from a Doctor in 2002. Ninety percent of consumers recalled information concerning the
benefits of the advertised drugs and 90% were aware of the risks or side-effects of
advertised drugs in 2002; both up slightly from the 1999 survey. Interestingly, the Kaiser
Poll reports however that only 18% of consumers trust what pharmaceutical companies
say in their ads ‘most of the time’. Despite this sceptical attitude, consumers take heed of
the ads and 64% who have seen the promotions for prescription drugs found that the
information was useful at least some of the time (Kaiser 2005).
It was also found that DTCA prompts consumers to seek medical advice about a new or
undisclosed condition; although the proportion of consumers taking this course of action
declined between the two surveys from 27% in 1999 to 18% in 2002.
The reasons given by consumers for visiting a doctor were health-related. Sixty-three
percent (63%) of people said that they visited the doctor in connection with an existing
condition, 59% were attending for a check-up and just 4% were seeking a drug that they
had seen advertised. Significantly 93% of respondents said that the doctor welcomed
their questions when they inquired about ‘prescription treatment’ but ‘advertising does
not appear to be the primary driver of doctor visits’ (Aikin et al. 2004, pp. 32-33).
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DTCA from a Consumer Perspective
One of the ‘clearest and strongest’ findings of the FDA research, according to the
authors, is that DTCA increases consumers’ awareness of new drug treatments (2004, p.
86). The authors also conclude that the advertising had motivated consumers to seek
additional information about a drug or their condition and, as has been demonstrated,
most consumers (89%) seek advice from a doctor. Further, DTCA was of value to
consumers by assisting them to guide their discussions with doctors and allowing them to
become more involved in their own healthcare (Aikin et al. 2004). In a special survey
directed at women, Kahn (2001) found that DTCA helped 75% of the sample to discuss
prescription medicines with their physicians. These 1,600 women found that magazines
were the best source of information on prescription medication.
Research in the United States and New Zealand indicates that there are few problems
with DTCA. Detailed and longitudinal research data interrogated by Calfee (2002)
demonstrates the overall attitudes towards DTCA were very positive and six lessons can
be learned from these data:
1. Consumer deception is not an issue.
2. DTCA provides valuable information to consumers.
3. DTCA motivates consumers to seek additional information from health
professionals and other sources.
4. Consumers like DTCA (Deshpande, Menon, Perri and Zinkhan 2004).
5. DTCA aids patient doctor discussions.
6. Spill-over benefits for consumers from DTCA include better knowledge of the
risks of medication, better compliance with drug therapies, and even motivation to
pursue lifestyle changes in the place of prescription drugs (Calfee 2002).
Lexchin and Mintzes (2002) question the findings from the surveys which measured
attitudes, beliefs and recall of past behaviour, indicating that this research ignored
consumer behaviour emanating from doctor-patient discussions.
More recently Mintzes, in a report for the Health Council of Canada (2006) that
attempted to resurrect the DTCA debate in Canada, asserted that there was no reliable
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DTCA from a Consumer Perspective
evidence to support the benefits of DTCA claims that had been made. A key benefit of
DTCA according to the proponents is that consumers are better informed about
conditions and treatments and are thus able to participate more actively in their own
health-care. Advertising has two functions, according to the economists, to inform and to
persuade (Berndt 2004); and if advertising increases market size without affecting a
brand’s market share, then ‘advertising is likely to enhance consumer welfare, for the
advertising must be providing information that taps unmet needs’ (Berndt 2005, p. 14).
Berndt then provided strong evidence from a number of econometric studies to support
his thesis, for example Rosenthal et al. (2003), Wosinka (2004), Iizuka and Jin (2005).
Berndt concluded his investigation as follows:
“To date the empirical evidence is quite consistent: When DTCA appears to have any
impact, the primary impact is via increasing market share, rather than affecting
individual market shares. This apparently robust finding emerges from a number of
recent studies.”
(Berndt 2005:15)
These robust findings were not mentioned by Mintzes but she did highlight two
innovative studies that provided some insight into decision making in the doctor’s
surgery (Mintzes et al 2003, Kravitz et al 2005). These works are analysed later but the
implication from both studies was that doctors were under some pressure from ‘ad savvy’
patients to prescribe an advertised drug. A number of studies have suggested that DTCA
encouraged consumers to seek medical help and to increase the flow of traffic into
doctors’ surgeries (Iizuka 2004, Iizuka and Jin 2005). However DTCA does not seem to
have interfered with the doctor-patient relationship since prescription choice was still
decided primarily by the doctor once patients made the surgery visit (Berndt 2005,
Rosenthal et al. 2002, Wosinska 2002).
Significantly, it has been convincingly
demonstrated that whilst DTCA was effective in increasing aggregate demand or
category sales, detailing by drug salespeople and medical journal promotions were more
effective in influencing brand choice (Donahue and Berndt 2004, Iizuka and Jin 2005).
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DTCA from a Consumer Perspective
The important study by Kravitz, Epstein, Feldman, Franz, Azari, Wilkes, Hinton and
Franks (2005), cited by Mintzes (2006), took us into the doctor’s office to assess
prescribing behaviour of doctors as a result of DTCA.
The rigorous study used a
randomised controlled trial and engaged actors called ‘standardised patients’ (SPs) who
presented at doctors’ offices with two levels of depression, requesting three levels of
information for treatment from ‘no medication request’, through ‘a general request’, to
‘request for a specific brand of drug’. Interestingly, ‘patients’ who made ‘brand’ requests
for information, and had either major depression or minor disorder, received
antidepressant prescriptions in similar proportions (53% vs. 55%).
Only 31% of
‘patients’ presenting with major depression, but making ‘no request’ was prescribed an
antidepressant. The findings of this study suggested that, although patients can influence
the treatment that they receive, doctors differed systematically in their propensity to
prescribe anti-depressant drugs; there was evidence of under-treatment of serious
depression and some over-treatment of less serious conditions (Berndt 2005).
When discussing this study with Dr Norman Swann of the Health Report on Australia’s
Radio National, Professor Kravitz explained that the ‘patients’ who presented with major
depression were about twice as likely to receive antidepressant medication when they
requested it than when no request was made (Swann 2005).
This comment was
questioned by Dr Swann:
“So what you are telling me is that an active consumer, and active patient, gets better
care than somebody who is passive.”
(Swann 2005)
Professor Kravitz went on to explain that possibly the low prescription rate was due to
the fact that the patient might be referred to a specialist or the doctor wished to monitor
progress before prescribing; this was subsequently termed ‘minimally acceptable care for
depression’. ‘The prescription rate for minimally acceptable care received for those
suffering serious depression was 98% making a general request, 90% making the brand
specific request and only 56% for those making no request’. Swann responded:
‘so, nearly half fell below the minimum standards.’
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DTCA from a Consumer Perspective
(Swann 2005)
Kravitz replied ‘you might ask how did you manage to recruit such a cohort of bad
doctors – but these doctors really aren’t bad at all, in fact they are among the better
doctors in the various communities that we studied.’
So how ‘good’ have doctors been found to be when managing patient healthcare through
the use of therapy? An exhaustive study entitled ‘The Relationship between Clinical
Experience and Quality of Healthcare’ by Choudry and colleagues (Choudry, Fletcher
and Soumerai 2005) produced some interesting results for patient care. The researchers
carried out a comprehensive systematic review to uncover 59 studies, or 62 evaluations,
between 1966 and 2004 that related physician knowledge to age and experience. They
found that 52% of evaluations reported decreasing doctor performance with years in
practice. More specifically, of the 19 studies that looked at adherence of standards to
appropriate therapy, it was found that 14 of the 19 (74%) evaluations reported a negative
association between doctor age and adherence to appropriate therapy standards; for
example with Beta-blockers and lipid-lowering agents. Doctors, it seems, are failing to
provide the appropriate therapy for their patients and the authors of this study recommend
quality improvement interventions (Choudry et al. 2005).
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DTCA from a Consumer Perspective
10.
DTCA and the Patient-Doctor Relationship
The healthcare landscape is complex and dynamic and is being influenced by a number of
factors, all of which impact on the doctor-patient relationship. The influencing factors
are the rise of consumerism, increasing litigation, direct-to-consumer promotion of drugs,
easy access to a multitude of sources about medical conditions, for-profit healthcare, and
the relentless pursuit of cost containment by health plans and government departments
(Gallagher and Levinson 2004).
It has been argued that DTCA may adversely affect the doctor-patient relationship and
lead to less than satisfactory health outcomes. Apart from the ‘philosophical’ concern
and the information asymmetry argument (Eagle and Chamberlain 2003), there appears to
be some concern that DTCA will affect the kind, and costs, of prescriptions given to
patients (Toop, Tilyard and Dowell 2003). On the other hand, a well-researched study by
Wazana (2002) has demonstrated that drug company sponsored continuing medical
education programs, and funding for travel and accommodation, were associated with
increased prescription rates of the sponsors’ drugs by attending doctors. Apparently
‘gifts matter’ and a number of organisations and government departments have developed
guidelines to ‘modulate the interaction between physicians and the pharmaceutical
industry’ (Wazana 2000, p. 379).
Consumers are becoming much more involved in their healthcare. Doctors are expected
to be ‘life-long learners’ in addition to running a business, managing staff, completing
forms from demanding bureaucracies – and this in a technically-complex and rapidly
changing healthcare environment. As populations age, surgeries are busier, subsidised
consultation times are shorter and doctors are under pressure ‘to meet customer needs’
(Weimers 2002, Axelroyd and Moore 2004, Gallagher and Levinson 2004).
Before DTCA and the internet the local doctor was the first point of call and probably the
sole custodian of key aspects of health data. The patient trusted the knowledge and
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DTCA from a Consumer Perspective
experience of the doctor who acted as an intermediary between two unknowns – the
patient’s condition and the innovative but distant providers of wonder drugs. Today the
patient is armed with vast quantities of data from numerous sources concerning
conditions, treatments, test data on latest ‘blockbuster’ drugs, and the medical profession
struggles to keep up to date with the latest advances in treatments, drugs, and ‘bed-side’
manners. But the doctor is still the most valuable source of healthcare information as
demonstrated by White et al. (2004) and other researchers (for example, Aikin et al.
2004, Allison-Ottey, Ruffin and Allison 2002, Prevention 2002), and the most trusted
according to Koch, Ernst and Kelly (2002) where doctors rated a 98% trust rating from
consumers. Both doctors and patients reported benefits and some problems with DTCA.
Almost three-quarters of physicians thought that patients asked thoughtful questions as a
result of DTCA exposure and that patients were better-informed and educated on
treatments and healthcare generally. Doctors were concerned however with the time
taken in correcting patient misconceptions and there were concerns that some of the
information lacked ‘balance’ (Weissman et al. 2004).
Consumers felt that they were able to have better, more informed and shared discussions
with their doctor as a result of DTCA. ‘Referrals’ from DTC ads were actionable as
more than 8 out of 10 patients who came to inquire about a condition were in fact
suffering from that condition. Advertised drugs discussed were prescribed less than 5%
of the time and often doctors took the opportunity to re-educate patients about different
treatments such as lifestyle changes (Aikin et al. 2004).
Over 80% of doctors in the FDA survey said that they welcomed questions from patients
prompted by DTCA (Aikin et al. 2004). White concludes ‘our data, along with 2002 US
FDA survey of 500 doctors, show that more information in the patients’ hands actively
stimulates something closer to true consultation with their physicians than was the case
prior to 1997’ (White et al. 2004, p. 59).
But in three countries where DTCA is banned, attitudes are less positive and there are
behavioural differences between doctors and patients. In the UK, doctors and hospital
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DTCA from a Consumer Perspective
specialists were highly opposed to the ‘concept and likely overall impact of DTC
advertising’. Further, these same doctors were also not in favour of recently introduced
‘see your doctor’ campaigns when 50% of the sample was unaware of the campaigns
even though they had been running for four years (Reast, Palihawadana and SpicketJones 2004).
An Australian study showed that consumers who had ‘high knowledge’ of prescription
advertising and drug regulation had a more negative attitude towards DTCA than those
consumers with ‘low knowledge’ (Vatjanapukka and Warszak 2004). Another piece of
research, however, found that 50% of Australian people felt that DTCA would be a useful
source of information for consumers and would increase public awareness of prescription
medicines; they also thought that DTCA would increase the price of prescription
medicines (Miller and Waller 2004).
A rigorous study by Mintzes and her colleagues demonstrated that American doctors in
Sacramento were more likely to prescribe an advertised drug than their Canadian
counterparts in Vancouver.
Seven percent of Sacramento patients requested an
advertised drug as opposed to 3% in Vancouver, and physicians fulfilled 78% of requests
for the advertised drug in Sacramento compared to 72% in Vancouver; this latter
difference did not appear to be significant (Mintzes, Barer, Kravitz, Bassett, Lexchin,
Kanzanjian, Evans, Pan and Marion 2003).
According to White et al. (2004), it is beyond doubt that doctors are being
‘disintermediated’ as the primary gatekeepers of health-related information, often by
other healthcare providers. As in many fields, laypeople can now read about the latest
advances in theory and practice as soon as they are published in specialist journals. The
fundamental question is:
‘Are doctors being displaced as the primary authority on individual patients’ care?’
White answers his own question in the negative, with the authority of 21,000 consumer
respondents (White et al. 2004).
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DTCA from a Consumer Perspective
However, it seems that physicians are concerned with the ‘gradual but pervasive
devaluation of the doctor-patient relationship’, caused fundamentally by the cost control
practices and policies of health plans and policy makers (Gallagher and Levinson 2004,
p. 61).
DTCA has not significantly impacted adversely on the patient-doctor relationship but it
seems to be a contributor in affecting the balance of power in discussions in the
consulting room (Weimers 2002).
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DTCA from a Consumer Perspective
11.
The Consumer and Medicalisation
Medicalisation is the process by which non-medical problems become defined and
treated as medical problems, usually in terms of illness and disorders.
Although
medicalisation is bi-directional, there is strong evidence for an increase in medicalisation
(Conrad and Leiter 2004).
The main factors that facilitate medicalisation are the
processes of supply and demand. On the supply side there is the historical power,
prestige and credibility of the medical profession which gave doctors jurisdiction over all
things illness or healthcare related. On the demand side there has been an increase in
demand for medical solutions to health problems (Conrad and Leiter 2004).
Mintzes asks the question ‘does DTCA broaden the domain of medicine beyond
reasonable grounds?’ (Mintzes 2002, p. 908). Mintzes argues that advertising campaigns
can lead to shifts in patterns of demand for healthcare services, citing campaigns in
Holland for toenail fungus where consultations increased ‘dramatically’ after a 3 month
unbranded promotion, and in the United States where a campaign for baldness resulted in
increased doctor visits. Mintzes points out that relatively healthy people are targeted and
that even when the focus is on the prevention of serious disease, the drug companies ‘cast
too wide a net’; for example, lipid-lowering drugs lower the incidence of serious heart
disease in men, yet the drug is under-prescribed to this group. It is more profitable to
promote primary prevention as more people are affected (2002, p. 908).
Irrespective of which drugs the pharmaceutical companies advertise, campaigns of which
people are aware and are more likely to pursue involve the following drugs and
conditions (Table 3).
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DTCA from a Consumer Perspective
Table 3 – Drugs, Conditions and Awareness Levels
Drug
Condition
Awareness level
Viagra
Erectile dysfunction
89%
Allegra
Allergies
81%
Lipitor
High cholesterol
77%
Zoloft
Depression
74%
Prevacid
Reflex/Ulcer
64%
Nexium
Reflex/Ulcer
58%
Singulair
Asthma
52%
(Prevention 2004)
The medicines that are growing most quickly in consumer awareness are Nexium and
Lipitor, and the annual sales of Lipitor are currently running at US$12 billion per annum
(Bowe 2005, p. 30). Viagra is showing a small decline in awareness (Prevention 2004).
Table 4 – Top Ten Prescription Drugs by DTCA Spend
Rank
Brand
Manufacturer
DTCA Spend Jan–Nov 2004 (US$m)
1
Nexium
Astra/Zeneca
226
2
Crestor
Astra/Zeneca
193
3
Cialis
Eli Lilly
153
4
Levitra
Bayer/GSK/S-P
142
5
Zelnorm
Novartis
122
6
Prevacid
TAP
119
7
Flonase
GSK
118
8
Singulair
Merck
108
9
Celebrex
Pfizer
104
10
Lipitor
Pfizer
104
14
Viagra
Pfizer
96
(Arnold 2005)
78
DTCA from a Consumer Perspective
Lexchin and Mintzes (2002) vigorously challenged the notion that many of the new drugs
promoted by the pharmaceutical companies brought significant benefits to the consumer.
They said, ‘important new medications are relatively rare’, and demonstrated that only
about 4 new drugs per year were ‘breakthrough’ medications (2002).
In a spirited response to the Mintzes stance in the medicalisation debate set up by the
British Medical Journal, Bonaccorso and Sturchio (2002) highlighted the epidemiological
evidence that showed ‘substantial under-diagnosis’ of major diseases and the known risk
factors for which treatments exist. Even when diagnosed, the diseases are still undertreated and, when non-compliance is factored into the equation (estimated at 50% of
prescribed medicines across all the major chronic diseases), avoidable morbidity and
mortality is the result. These data ‘make the most powerful case for greater public
awareness of the benefits of modern medicines’ (Bonaccorso and Sturchio 2002, p. 2). It
has also been seen that direct-to-consumer promotion from pharmaceutical companies
has an educational function in that it can keep consumers informed about healthcare,
particularly diagnoses, risks, and potential treatments.
The growing band of old
consumers especially value DTCA and its ability to prepare them for discussions with
their doctors (Huh, DeLorme and Reid 2004). Poor communication between doctor and
patient ‘is known to lead to suboptimal health outcomes – consumers need information to
make informed choices about their health’ (Bonaccorso and Sturchio 2002, pp. 2-3). In
Australia the medicalisation debate has been refuelled in 2005 by an article from Dr. Con
Costa of the Doctors’ Reform Society. He suggests that dementia and osteoporosis are a
natural part of the ageing process and that the pharmaceutical industry is ‘medicalising’
these conditions (Costa 2005). He also questions the commitment by the industry to high
cholesterol and impotence conditions.
In a response to the claim by Costa that
osteoporosis and dementia are ‘newly manufactured’ by the pharmaceutical industry,
Kieran Schneemann (2005) rebuts the argument. He points out that many of the drugs
available today are ‘discovered, researched, manufactured, trialled, registered, supported
and marketed by pharmaceutical companies’. It is totally appropriate that continuing
education about new and existing drugs is supported by the companies that know most
about them (Schneemann 2005, p. 23). As evidence Schneemann directs Costa to a new
79
DTCA from a Consumer Perspective
website by the International Federation of Pharmaceutical Manufacturers and
Associations which has more than 250,000 links to clinical trials around the world; an
indication of the transparency and remarkable research being done to save lives
(Schneemann 2005, p. 23).
There is anecdotal evidence that points to the ‘comodification’ of medical goods and
services and that drug manufacturers benefit from this process through above-normal
profits of around 14% return on sales revenue (Richardson and Luchsinger 2005). Over
time, as drugs come off patent and reach ‘commodity status’, prices are forced down and
advertised brands lose market share to the new generic products. In a study conducted by
Haas and colleagues (2005), it was found that 56% of all prescription medications were
multi-source products. Of these multi-source drugs, 61% were dispensed as a generic
and prescriptions for generics increased by 6% over the study period; if a generic had
been substituted for all corresponding brand name drugs, adults over 65 years would have
saved US$78.05 in the year (Haas, Phillips, Gerstenberger and Seger 2005). Further, in
the last twenty years or so, the FDA has moved more than 600 drugs from prescription to
OTC, including nicotine patches and anti-inflammatory treatments (Calfee 2002). OTC
drugs generally earn lower profit margins than branded products. In normal market
conditions these moves would adversely affect the profitability of the key players. It
seems that these processes are part of the ‘balancing’ mechanism that occurs in the
pharmaceutical industry.
The medicalisation concept was introduced into the literature in the 1990s, since when
there have been significant changes in the pharmaceutical industry.
The medical
profession used to dominate the industry but now consumers and advocacy groups,
providers (doctors, hospitals), payers (insurance companies and governments) and buyers
(companies that buy health insurance for workers) all compete for power and influence
over healthcare. If there is an acceleration of the medicalisation process through rising
consumerism and the industry, the brakes are applied through insurers and governments
(Conrad and Leiter 2004) bringing restraint to a process that some would liken to a
runaway train.
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DTCA from a Consumer Perspective
12.
DTCA, Economics for the Consumer and Prices
Spending on prescription drugs, accounting for around 10% of healthcare expenditure in
the United States, has been growing rapidly (National Institution of Health Care
Management (NIHCM) 2002). There has been some speculation about the causes of the
increase in this spending growth. Some studies have suggested that increased drug prices
are the main culprit (Kaiser Family 2003), whilst others ascribe the increases to the
rapidly ageing population and the increased uptake of available treatments. However,
according to the most recent statistics, the rate of drug spend growth is starting to slow
down. This is due to a fall in the number of prescriptions dispensed, a change in payment
plans, the conversion of a popular allergy medication to OTC status and a number of
drugs losing patent protection (Content Management System (CMS) News 2005).
It has been claimed that Pharmaceutical companies charge high prices for new drugs and
that drugs are promoted selectively (Mintzes 2002, Kaiser Family 2003), but new OTC
and generic drugs represent considerable savings for the consumer. Newer drugs are
more expensive as they attempt to make a contribution to the recovery of invested R and
D costs, but it is argued that newer drugs are more effective and lower the costs of nondrug spending; for example, replacing a 15 year-old drug with a new one increases drug
spend by US$18 but reduces overall cost by over US$100 on average (Auton 2004).
It has also been argued many times that DTCA leads to an increase in drug prices; the
assumption being that advertising costs are added to the costs of the drugs to arrive at the
price. It is also argued by economists that advertising leads to an increase in demand and,
other things been equal, an increase in demand leads to an increase in price. The United
States General Accounting Office (USGAO) has reported in a study that the most heavily
advertised drugs outsold those that were less heavily advertised by a factor of 6 to 1. The
prices of the heavily advertised drugs increased by 6% over the year, whilst the price of
the other drugs rose by 9%. The USGAO report concluded that advertising had increased
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DTCA from a Consumer Perspective
prescription drug utilization which, in turn, had influenced prescription drug expenditures
rather than price (USGAO 2002).
A study by Anantharaman, Anju and Shepherd (2005) found a weak relation between
DTCA expenditure and price for 20 heavily-advertised drugs. More significantly, the
researchers found that lower prices were associated with higher DTCA costs and high
price changes associated with lower changes in DTCA costs. The authors concluded that
DTCA costs did ‘not drive price increases’ (2005, p. 15).
Three important studies by economists used interrupted time-series analyses with beforeafter measures to measure the impact of DTCA on consumer behaviour (Basara 1996,
Zachry et al. 2002, Jong et al. 2004). The time-series studies indicated that DTCA was
effective in increasing prescribing volume for advertised drugs for migraine, statins, and
for a fungal nail condition.
It has been estimated that for every additional dollar spent on DTCA by drug companies,
sales increased by US$4.20 (Kaiser Family 2003). This calculation appears optimistic
however and detailing (personal selling) has been shown to be a better investment of
marketing funds. Another more sophisticated study by Wittink (2002) found that brands
that had at least US$500 million in annual revenues had a detailing return of US$11.60,
but a DTCA return of US$1.30.
Taking these studies one step further Narayanan,
Desiraju and Chintagunta (2004) compared the performances of well-advertised
antihistamine drugs Claritin, Zyrtec, and Allegra with a much smaller DTCA spend on an
antiviral Valtrex. Detailing returns for the antihistamines were US$1.49 for Claritin,
US$1.28 for Allegra and US$1.10 for Zyrtec; DTCA returns were less than one dollar for
Allegra (85 cents), Claritin (66 cents) and Zyrtec (67cents). The returns for the less
advertised Valtrex were 68 cents return on DTCA and US$2.85 on detailing for every
US$1 invested.
DTCA does not appear to deliver positive returns on investment in all cases.
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DTCA from a Consumer Perspective
It would appear, then, that firms could increase returns on marketing funds by switching
expenditure from DTCA to detailing. But Narayanan and his colleagues (2004) found
that there was a positive interaction between detailing and DTCA and that there was a
synergy between the two activities. The sales call on the doctor which emphasized the
therapeutic benefits of the brand had a greater impact when combined with an
advertisement, which prompted patient questions about the drug and the long term ‘carryover’ effects boosted returns even more; up to around US$8 for detailing and US$1.37
for DTCA for the major category drugs.
In another study, the median return on investment for DTCA was found to be US$2.20
for each dollar invested. Twelve of the sixty-four drugs studied provided returns in
excess of US$4.50, for example statins and asthma drugs, whilst seven brands generated
negative returns (Arnold 2005). Another study found that detailing by pharmaceutical
sales forces had a much greater effect on medication choice in the anti-depressant market
than DTCA (Donohue and Berndt 2004).
To put marketing expenditures by drug companies into perspective, detailing outspends
DTCA by a factor of 2:1, and sampling outspends DTCA by almost 4:1 (Auton 2004).
83
DTCA from a Consumer Perspective
13.
Conclusions
The marketing of prescription medicines is a complex process that stretches the ingenuity
of those people who endeavour to provide understanding in the area. DTCA is one
element of the marketing of prescription drugs that has attracted much attention.
Attention that is disproportionate to advertising’s contribution to the marketing process; it
accounts for less than one-sixth of marketing spend of pharmaceutical companies
(USGOA 2002). However as many marketing writers say, attributing the words to an
eclectic mix of gurus:
‘Half of the money that we spend on advertising is wasted, but we do not know which
half.’
(Lord Leverhulme)
DTCA spending is currently running at over US$4 billion worldwide (Arnold 2005), yet
much of the research into the area does not attempt to address the conundrum raised by
Lord Leverhulme.
For almost two decades now the opponents and proponents of DTCA of prescription
medicines have waxed lyrical in their attempts to develop convincing arguments to
‘prove’ their case. The arguments have remained largely unchanged and it has become
clear that rhetoric, no matter how often or how long it is repeated, does not advance
understanding of the issues involved in DTCA. There is a need for good data and sound
evidence.
In marketing research there are three approaches to data collection and
analysis:
1. Exploratory research which is undertaken to provide a better understanding of
the general nature of a problem. Such research is highly flexible, unstructured,
qualitative and exploratory, or tentative, in nature.
2. Descriptive research provides a summary of certain aspects of the environment
and answers the ‘who’, ‘what’, ‘where’, ‘when’ and ‘how’ questions. It may also
84
DTCA from a Consumer Perspective
infer a relationship between two variables, for example age and knowledge, but it
does not provide a causal link. Most commercial research is descriptive in nature.
3. Causal research is the most rigorous and demanding research approach because
it shows that one variable causes or determines the value of another, for example
sales promotions increase sales. It provides the type of evidence that is closest to
the ‘proof’.
(Aaker, Kumar, Day and Lawley 2005)
Most of the work that is available and that we have reviewed in this report is of an
‘exploratory’ or ‘descriptive’ nature and has dealt with the question:
‘What is the nature and scale of DTCA?’
To answer the question:
‘What are the effects of DTCA on consumer knowledge, attitude and behaviour
with respect to healthcare?’
we have reviewed descriptive and more limited causal research.
Some of this research has been questioned by Mintzes, in a report for the Health Council
of Canada (2006) that attempted to resurrect the DTCA debate in Canada. Mintzes
asserted that there was no reliable evidence to support the benefits of DTCA claims that
had been made. The industrial economists have demonstrated convincingly the welfare
effects of DTCA and a number of studies have suggested that DTCA encouraged
consumers to seek medical help and to increase the flow of traffic into doctors’ surgeries.
The Canadian Health Council needs to provide similar ‘robust evidence’ to counter these
claims.
We have seen that DTCA has enjoyed a steady growth and has endeavoured to provide a
balance of information for interested stakeholders; on occasions with the help and
85
DTCA from a Consumer Perspective
guidance of regulatory bodies. DTCA uses a number of media to communicate its
messages and a number of appeals. TV and the internet are becoming dominant in the
integrated marketing communications mix used by companies, as complex messages can
be managed effectively and efficiently on company websites. Some of the emotional
advertising appeals used on TV have angered critics of DTCA and on many occasions
pharmaceutical companies have been criticised for failing to provide information with the
required ‘balance’ of benefit and risk.
The DTCA Model
There is much descriptive research that has helped us to explore the way in which DTCA
affects consumer awareness, knowledge and attitudes. Some insight and understanding
of the way that this market works and is influenced can be obtained by analysing a
model, the ‘hierarchy of effects,’ developed by Lavidge and Steiner (1961) and since
modified in a healthcare context by Menon et al. (2004). The model postulates that
advertising messages affect consumer behaviour in a hierarchical manner from a state of
unawareness of a condition or drug, through awareness, attention, comprehension,
attitude, drug inquiry, drug request, and compliance with drug regimen; the whole
process regulated through consumer rights, knowledge, empowerment and protection
(Figure 5).
According to White et al (2004) the US healthcare market segments into 2 basic sectors, a
‘healthy half’ and half the population who suffer from increasingly lifestyle-restricting
conditions. The first step in the ‘hierarchy’ model: DTCA awareness levels in the whole
population are in excess of 90% as reported in a number of studies and over time
(Prevention 2004, FDA 1999, 2002).
Disease awareness campaigns seemingly are
noticed by the healthy as well as the unhealthy and acted on by both segments in terms of
doctor visits (Weissman et al. 2003). Awareness of conditions and the top ten drugs by
advertising spend was high in the population (Arnold 2005, Prevention 2004), indicating
some recall and recognition of the ad and the drug.
86
DTCA from a Consumer Perspective
The knowledge and comprehension step in the model is concerned with the way in which
consumers process information from DTCA and use the information when seeking
further information and making drug choices. There is evidence from the foregoing
literature that consumers have difficulty in accessing and processing drug information,
particularly older consumers, for example fewer than 50% of consumers used ad
information in their healthcare decision making. Some consumers felt that ads can
overstate drug efficacy (Vogt 2005). With a ‘high’ involvement product like drugs,
consumers need ‘balanced’ information to facilitate the decision making process; DTCA
utility was influenced by positive perceptions of the quality of risk and benefit
information and consumers with positive opinions of DTC ad utility used this information
more in their decision making. Ads need to be clear and comprehensible (Deshpande et
al. 2004).
87
DTCA from a Consumer Perspective
Figure 5 – The DTCA Model
Consumer
Rights
Adherence to drug regimen/refill behaviour
C
o
n
s
u
m
e
r
Drug request behaviour
Drug inquiry intent
Info search using sources of adequate provision
E
m
p
o
w
e
r
m
e
n
t
C
o
n
s
u
m
e
r
Attitudes towards DTCA
Comprehension of drug risks and benefits
Awareness of DTCA and drug indication,
recall and recognition of ad and drug
Attention to DTC ad
K
n
o
w
l
e
d
g
e
Aware – result of DTCA
Unaware of Condition (drug)
Consumer
Protection
(Source: Developed from authors referenced in this study)
The next step of the model is concerned with attitudes of consumers. The social
psychology and marketing literature tells us that attitude towards an ad affects cognitions
and perceptions towards the advertised brand and may influence purchase intent. The
DTCA literature over the last two decades has been consistent with the finding that
consumers have a favourable attitude toward DTCA, particularly with respect to the
educational value of campaigns (Calfee 2002) and the ability of DTCA to provide
consumers with information ‘that they rightly deserve to know’ (Menon et al. 2004).
Drug inquiry intent or stimulating consumers to seek out further information as a result
of DTCA is the next step in assessing the effectiveness of DTCA. Information searching
88
DTCA from a Consumer Perspective
is an important part of consumer behaviour, particularly with regard to high involvement
products and services. In drug consumer behaviour, the theory and practice endorse
information-seeking activities as consumers gather information from websites, toll-free
numbers, print ads, and healthcare professionals to inform the decision making process.
The foregoing literature provides abundant evidence of this activity.
Once the consumer has collected and evaluated the relevant information, the next crucial
step in the effectiveness model is drug request behaviour. Some researchers have
suggested that doctors are under pressure to prescribe prescription medicines requested
by their patients (Mintzes et al. 2003, Kravitz et al. 2005). On the other hand, the
Prevention surveys have shown that, despite the growth in DTCA over the last decade,
requests from patients of their physicians for or about advertised drugs has remained
constant at around 8% and the author concludes that ads ‘can’t overcome Americans’
desire to avoid taking prescription drugs’ (Vogt 2005). Seven percent of consumers
asked for and received a prescription drug because of DTCA and this is increasing by
around 3% per year (Prevention 2003).
The final stage in the DTCA effectiveness model is the extent to which the consumer
remains ‘loyal’ to the brand or adheres to the drug regimen.
Some authors have
suggested that DTCA acts as a ‘reminder’ and reinforces compliance with drug therapy
or reinforces information by word-of-mouth.
Petersen’s work on personalising
communication to patients and compliance is significant; this strategy reduced emergency
medical visits by 80% compared to 18% reduction in the control group and led to a 100%
reduction in hospitalisation costs, compared to a 4% reduction in the control group (Eagle
and Chamberlain 2003).
It is also possible that, as ‘risk’ information becomes more widely disseminated and
better understood, some patients may cease the treatment of the ailment as reported in
Prevention when 7% of respondents dropped the drug after seeing it advertised (2004).
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DTCA from a Consumer Perspective
In summary, the hierarchy of effects model provides a useful framework for gaining
greater insight into the effectiveness of DTCA. The descriptive research that we have
reviewed indicates:
•
DTCA appeared to increase consumer awareness of conditions and treatments.
•
DTCA has assisted consumers to discuss conditions and treatments with their
physicians.
•
Consumers are apparently now taking more responsibility for their own
healthcare.
•
DTCA has been less effective in terms of consumer comprehension of drug
benefits and risks.
•
Whilst drug request behaviour has remained constant over time in the United
States, there are some indications that DTCA has been effective in encouraging
drug compliance.
However, much of the research into DTCA has been more concerned with ‘describing’
behaviour and less concerned with ‘explaining’ behaviour. The model has stood the test
of time but, good as it is, the DTCA version would be better informed and more robust if
the literature provided us with ‘sounder’ evidence. It seems that the jury is still out on the
effects of DTCA on actual consumer behaviour.
It has been said that ‘the absence of evidence is not evidence of absence’ (Rosenthal et al.
2002), but the extent and effect of DTCA has yet to be summarised in a comprehensive,
relevant and rigorous manner (Gilbody et al. 2005). In company with Gilbody we were
unable to find significant studies that actually demonstrated the impact of DTCA on
consumer behaviour; specifically what did consumers do differently as a direct result of
DTCA?
We sought studies that not only described variables and established loose
relationships but studies that clearly indicated a causal link between variables; for
example, drug ‘x’ ads cause increased compliance of drug x. We looked for studies that
used rigorous experimental designs with controls or multi-measure interrupted timeseries that demonstrated causal relationships between variables. We have reported 5 such
studies:
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DTCA from a Consumer Perspective
1. Basara Lisa Ruby (1996).
2. Zachry W M 3rd, M D Shepherd, M J Hinich, J P Wilson, C M Brown and K A
Lawson (2002).
3. Jong Geert W 't, Bruno H Ch Stricker, and Miriam C J M Sturkenboom (2004).
4. Mintzes Barbara, Morris L Barer, Richard L Kravitz, Ken Bassett, Joel Lexchin,
Arminee Kanzanjian, Robert Evans, Richard Pan and Steven A Marion (2003).
5. Kravitz Richard L, Ronald M Epstein, Mitchell D Feldman, Carol E Franz,
Rahman Azari, Michael S Wilkes, Ladson Hinton and Peter Franks (2005).
The first three studies were interrupted time-series analyses with before-after measures,
and the last two studies were quasi-experimental designs with control groups. The timeseries studies indicated that DTCA was effective in increasing prescribing volume for the
advertised drugs, whilst the controlled experiments gave some insights into the
prescribing behaviour of doctors in consultation with patients.
DTCA is banned in Canada, where Mintzes (2003) and colleagues used a cross-sectional
survey administered to doctors and patients in the USA and Canada to assess the impact
of DTCA in the two markets. The US patients from Sacramento were twice as likely to
request medications as their Canadian counterparts from Vancouver, and twice as likely
to request advertised drugs. Patients who requested DTCA medications were 17 times
more likely to receive a prescription than patients who made no request for medication,
even though the doctors prescribing the drug were ambivalent – half the time – about the
treatment. Doctors in both locations were found to be likely to acquiesce to patient
requests.
From the experimental evidence presented by Kravitz et al (2005) it seems that there is
both under-treatment of depression and over-treatment with antidepressants. It appears
that patients have some impact on doctors and influence the treatments that they receive
but, as has been said, doctors seem to differ systematically in their propensity to prescribe
antidepressants (Berndt 2005). This study raises some interesting questions about the
prescribing behaviour of physicians. A study by Choudry et al. (2005) indicated that
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DTCA from a Consumer Perspective
patients were receiving less than adequate healthcare from some doctors who were failing
to conform to appropriate therapy standards; specifically there was a negative association
between the age of the doctor and adherence to appropriate therapy standards.
These five, important studies have given us the first real insight into the effects of
advertising on consumer healthcare behaviour because they are able to isolate the effects
of advertising from all the other variables that could affect that behaviour. All these
researchers have conceded the limitations of their studies that affect the interpretation of
the results. However, research is an iterative process and although rigorous research is a
‘late starter’ in the DTCA field, a bold start has been made and the foundations have been
laid for rigorous future research. We must learn much more of how and why consumers
and healthcare providers behave in the way that they do.
However, the DTCA literature is increasing in scale and complexity. In summary, the
descriptive and causal research studies that we have evaluated in this systematic review
of the DTCA literature from a consumer perspective have provided valuable insights into
the nature, extent and effects of direct-to-consumer-advertising of prescription medicines:
•
Consumers are more aware of conditions and treatments.
•
DTCA increases the demand for treatments and medicines.
•
Consumer attitudes towards DTCA are more positive in countries that have
DTCA than those that do not, for example, the UK, Australia, Europe.
•
Some consumers are better educated about conditions and treatments.
•
Some consumers are better prepared for doctor discussions.
•
Older populations mean older doctors whose performances decline with time.
•
Many doctors welcome informed discussions from patients; a small proportion do
not.
•
Detailing appears to have a much greater effect on medication choice than DTCA.
•
There appears to be a DTCA information problem.
•
DTCA can facilitate the compliance process.
•
DTCA appears to influence prescribing behaviour of doctors.
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DTCA from a Consumer Perspective
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Appendix
A Systematic Search for Appropriate Randomised Controlled Trial
Research Data Pertaining to: Direct-to-Consumer-Advertising of
Prescription Medicines
Introduction
We carried out a systematic review according to clear and defined guidelines and our
results are presented according to guidelines laid down in the QUOROM statement
(http://www.consort-statement.org/QUOROM.pdf 2005).
Objectives
Following the detailed review by Gilbody, Wilson and Watt (2005) on the benefits and
harms of DTCA of prescription medicine, we searched for new research studies
undertaken on the same subject after October 2004 that could, as a consequence, form the
basis of an updated review on the subject.
Data Sources
We searched a wide range of databases from medical, academic, marketing and public
Internet sources, these databases included; ABI/Inform Global, Academic Research
Library, AMA Titles, Oxford Journals (Health Education Research), Health & Medical
Complete, Pharmaceutical News Index, Proquest Social Science Journals, Proquest 500,
HSRProj, NHS, Medline & Medline Plus, Psycinfo, Blackwell-Synergy, Informit,
Meditext, AMI, Jama and Ovid.
Review Methods
The selection criteria for the searches were date and content related to free text and key
word phrases pertaining to ‘direct to consumer advertising’, ‘DTCA’ and ‘prescription
106
DTCA from a Consumer Perspective
medicines and drugs’. The date criterion included all applicable data after October 2004
(the cut-off date for Gilbody, Wilson and Watts’ (2005) research). This data was further
defined to meet the content criteria of free text phrases that included ‘randomised
controlled trials’, or ‘controlled clinical trials’, or ‘interrupted time series analysis’, or
‘controlled before and after studies’, or ‘controlled group research’, or ‘comparative
history’, or ‘cost and consequence analysis’. Research studies covering general surveys,
letters or statements were subsequently excluded from the searches, as well as research
conducted prior to October 2004. The results of the searches looked at the closeness of
the relationships of the data to meet the defined criteria, and their applicable subject
matter and format, the preliminary data was tabulated in Table 1 and reviewed.
Table 1 – Results of Searches
Database
Basic key words
ABI/Inform Global
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
‘direct to consumer advertising’
‘prescription medicine or drugs’
AMA & Medical
complete
Oxford Journals, Health
Education Research
Pharmaceutical News
Index
Proquest 500 using
multiple databases
Medline
Psycinfo
HSRProj
Meditext
Ovid
JAMA
Internet Search (see
Appendix 2 for details)
and
Number
of
matches
317
Exact
match to
criteria
0
and
207
0
and
0
0
and
56
0
and
400
0
and
2
0
and
16
0
and
4
2
and
8
0
and
5
0
and
21
1
and
170,000
4
107
DTCA from a Consumer Perspective
Figure 1 – Systematic 2005 Search Flow Chart
Potentially relevant samples identified and
screened for retrieval from basic internet
search: (n = 681); excluding reference lists
and citations
Potentially relevant samples identified and
screened for retrieval from Identified
databases: (n = 3); excluding reference
lists and citations
Total potentially relevant samples
screened for retrieval: (n= 684)
Potentially relevant samples excluded
(n = 677) either clearly not controlled
or did not fulfil inclusion criteria
Potential samples retrieved for more
detailed evaluation (n = 7)
Potential studies excluded (n = 2):
either clearly not controlled or did not
fulfil inclusion criteria
Potentially appropriate reports of
studies to be included in the systematic
review as a narrative synthesis: (n = 5)
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DTCA from a Consumer Perspective
Broad based search criteria for matching and results, using http://www.google.com
internet search engine.
Exact Phrase: DTCA
Results:
205,000 sites
Comments:
Many alternative meanings for DTCA such as Directorate of Technical
Cooperation Africa
Exact Phrase: “direct to consumer advertising” and “Medicine” or “Drugs”
Results:
170,000 sites
Exact Phrase: “Prescription Medicine”
Results:
31 sites
Comments:
Search within the results of Item 2 above.
Exact Phrase: “2005”
Results:
0 sites
Comments:
Refined search within the results of Item 3 above.
Exact Phrase: “Prescription Drugs”
Results:
17,800 sites
Comments:
Refined search within the results of Item 2 above.
Exact Phrase: “research”
Results:
12,800 sites
Comments
Refined search within the results of Item 5 above.
Exact Phrase: “2005”
Results:
725 sites
109
DTCA from a Consumer Perspective
Comments
Refined search within the results of Item 6 above.
Exact Phrase: “controlled trial” or “time series”
Results:
681 sites
Comments
Refined search within the results of Item 7 above.
Potentially relevant samples identified and screened for retrieval (n=681); excluding
reference lists and citations.
110