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Direct-to-consumer prescription drug advertising: is there evidence of health benefits?

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Barbara Mintzes at University of British Columbia
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19
E S S E N T I A L D R U G S M O N I T O R
Issue No. 31, 2002
D R U G P R O M O T I O N
Direct-to-consumer prescription
drug advertising: is there
evidence of health benefits?
➢ B
ARBARA
M
INTZES
*
RESSURE from the pharmaceutical
industry and related lobby groups
to allow prescription drug adver-
tising to consumers is growing
in Australia, Canada and the European
Union. Proponents of direct-to-consumer
advertising (DTCA) argue it would be
a way to empower patients. But is that
actually true?
Arguments favouring
direct-to-consumer advertising
◆people want and need information
on medicines;
◆advertisements will help people to
get needed medical care at an
earlier stage;
◆advertisements will lead to better
compliance;
◆a doctor’s prescription is needed,
so the patient will still be
protected.
Arguments against
direct-to-consumer advertising
◆prescription drugs are not like
other consumer goods. Even when
used properly, they can cause
serious harm;
◆people are vulnerable when they
are ill;
◆advertisements aim to stimulate
sales – they cannot provide
impartial, objective information;
◆advertising drives up prescription
drug costs and total health care
costs.
The US experience
The US has never had a law
prohibiting DTCA. The first print direct-
to-consumer advertisements appeared
in the early 1980’s. However, in 1982 dis-
aster struck when a new anti-arthritic
drug was recalled by the Food and Drug
Administration (FDA) after only five
months on the market because of severe
adverse effects, including deaths. The
FDA’s action came after the company had
mounted an intensive public relations
campaign aimed at health professionals
and the public. In its wake, prescriptions
for the drug rocketed from 2,000 to
55,000 a week, earning the manufacturer
more than US$1 million a week in sales.
Following this case, the FDA called for
a moratorium on DTCA of prescription
drugs so that there could be wide con-
sultation with all stakeholders. In 1985,
two years later, the moratorium was
lifted.
In 1997 the FDA issued new guide-
lines that relaxed the regulations
governing TV and radio advertising.
In effect it greatly reduced the amount
of risk information broadcast adver-
tisements had to include. Before that,
broadcast advertisements were bound by
the same regulations as the information
sent to health professionals, including the
full approved product labelling informa-
tion on risks and contraindications (what
the FDA calls the “brief summary”).
Since the early 1990’s spending on
DTCA has grown exponentially from
approximately US$55 million in 1991 to
US$2.5 billion in 2000.
Effects on spending
How has DTCA affected health
spending in the US? In 1999, US con-
sumers spent US$111.1 billion on retail
prescription drugs – up from US$93 mil-
lion just one year earlier. Interestingly,
the top 25 prescription drugs advertised
to the public accounted for US$7.2 bil-
lion of the US$17.7 billion increase
(40%). In 2000, the top 50 advertised
prescription drugs accounted for
US$9.94 billion of the US$20.8 billion
increase over 1999 (48%). This rapid in-
crease in drug costs reveals two trends:
that DTCA has led to more prescriptions
per person, and that it has increased de-
mand for newer, more expensive drugs.
What products are being advertised
for which health conditions? Around 40%
of the money spent by companies to ad-
vertise directly to consumers each year
is spent on only 10 drugs. Most drugs are
never advertised to the public. Because
so few drugs are advertised to consum-
ers, DTCA is a poor means of informing
patients about the treatment options
available. The top 10 drugs are typically
costly, new drugs meant for long-term use
by a large target audience. They include
treatments for common, mild problems
such as allergy and “lifestyle” conditions
including baldness, impotence and
shyness.
Consumers’ reactions
US consumer surveys have been
carried out to find out more about the
public’s views on DTCA. In national
surveys, 25% of respondents spoke to
a doctor about a drug or condition in
response to direct-to-consumer adver-
tisements – and 6–9% reported having
directly requested a drug from their
health care provider, most of whom
(80–84%) received a prescription.
The idea that the doctor will still be
able to protect the patient from toxic
medicines falls short if the doctor sim-
ply prescribes what the patient asks for.
One has to ask: how well do consumers
actually understand direct-to-consumer
advertisements? In a California survey,
43% – nearly half of the respondents –
thought that only completely safe medi-
cines could be advertised to the public.
Another national survey carried out by
the FDA found that over half of res-
pondents could not explain what
prescription-only status meant.
Do advertisements lead
to an informed, educated
consumer?
The quality of US direct-to-consumer
advertisements
In the US, many TV advertisements
have been found to be in violation of
regulations and there are frequent infrac-
tions. To be more specific, 17 of 33 (52%)
of US TV advertisements violated FDA
regulations in 1998. The agency sent out
94 notices of violations between 1997
and mid-2001 (48 broadcast, 46 print).
The key reasons included inadequate risk
information, exaggerated benefits and
unapproved uses.
Direct-to-consumer advertising
in New Zealand
Like the US, New Zealand has DTCA
by default, as there has never been a
law against it. It just wasn’t done until
recently. While the FDA regulates DTCA
in the US, New Zealand relies on indus-
try self-regulation, like many European
countries. This often means that adver-
tisements include less risk information
than those appearing in the US. In Feb-
ruary 2000, MedSafe (the country’s drug
regulatory agency) checked compliance
on direct-to-consumer advertising and
found that five out of six voluntarily
submitted television advertisements
and one-quarter of print advertisements
violated the Medicines Act. The main
reasons were inadequate or absent risk
information. Pharmac, New Zealand’s
drug management agency, commissioned
a survey in 2000 on consumer responses
to an advertisement that had been found
to violate the Act because of inadequate
risk information. Pharmac showed the
advertisement to 200 women aged 16–30
and asked them a few questions. Nearly
half of them thought the advertisement
provided enough information to decide
whether to take the drug. One-quarter
thought that it clearly stated risks and
side-effects. In fact, the only risk infor-
mation was a line in tiny print saying that
the risks were similar to other drugs used
for the same indication. This was untrue
and did not explain what those risks were.
The example suggests that misleading
advertisements work, and shows how
difficult it can be for the public to judge
P
...cont’d on page 20 ➠
and consumers about drug promotion.
Drug promotion will undoubtedly con-
tinue as a major industry tool to increase the
sales of its products. Our task is to under-
stand and educate both health professionals
and consumers about the limitations of ethi-
cal drug promotion as a source of treatment
information; its considerable potential for
harm when inaccurate, inappropriate or
biased; and its powerful influence on pre-
scribers and users. Promotion is a reality
of the commercial market place but we
need to ensure that drug promotion:
➤is adequately regulated;
➤problem areas are rapidly identified and
tackled;
➤potential influence on treatment deci-
sions, outcomes and costs is better
understood;
➤is adequately balanced by complete
and scientifically validated sources of
treatment information. ❏
Dr Joel Lexchin is an emergency physician in
Toronto, Canada, and teaches health policy
at York University. He designed the database,
and collected and organized the initial 2200
items.
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... Over the past few years there has been increased pressure from pharmaceutical industry and related lobby groups to allow DTCA for prescription drugs in Australia, Canada and the European Union (Mintzes, 2002;Mintzes et al., 2003). A recent shift in the interpretation of policy governing this DTCA marketing strategy has seen its partial introduction into countries such as Canada and some of the European countries for the following disease areas: AIDS/HIV, diabetes, and asthma (The Lancet, 2002;Watson, 2002). ...
... The educational value of DTCA is often poor (Donovan, 1999;Avorn, 2003) with a greater emphasis on the use and benefits of treatment (Mintzes, 2002), downplaying the safety information (Lexchin and Mintzes, 2002). Analyses of print DTC advertising content have found inaccuracies (Newby and Henry, 2002) and inadequate risk information (Roth, 1996). ...
... Currently the US and New Zealand are the only industrialised countries that allow DTCA for prescription drugs (Gold, 2003). This may soon change however, with increased pressure from pharmaceutical industry and related lobby groups in Australia, Canada and the European Union (Mintzes, 2002). The increase in DTCA in the US has had a huge impact in terms of public awareness of prescription drugs. ...
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Purpose This paper aims to investigate older consumers' perceptions of the effects of direct‐to‐consumer advertising (DTCA), their views on the amount and type of information that should be provided, and their understanding of information typically contained. Design/methodology/approach Participants were 97 adult members of a social/education group, aged 55 to 87, who completed a questionnaire during the group's usual weekly meeting. There were four versions of the questionnaire; two types of medication (arthritis versus diabetes) and two ad formats (short versus long). Findings There was little difference between the versions in the accuracy of participants' recall of key pieces of information, suggesting that providing additional information may convey little additional benefit. Participants reported limited perceived benefits of DTCA, and expressed concern that DTCA may cause people to ask their doctor for inappropriate medicines, rely more on medicines to solve their health, and become more confused. Practical implications This study suggests that there is a need to consider consumers' perceptions of benefits and costs of DTCA when deciding whether to introduce it (e.g. in Australia) or remove it (e.g. New Zealand). Further, at least for older consumers, providing large quantities of information may increase cognitive demands without producing additional benefits. Originality/value The majority of previous studies of DTCA have used either student samples (with manipulated salience of information) or general population surveys. This study utilised a sample of older adults, including 55 per cent with arthritis and 13 per cent with diabetes. Further, as this study used US ads with an Australian population, one can be confident that participants' knowledge of the medications was purely from the ads read and not from previous exposure.
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... The United States (US) and New Zealand (NZ) are currently the only industrialised countries that allow Direct-To-Consumer-Advertising (DTCA) for prescription drugs (Gold, 2003). Over the past few years however, there has been increased pressure from the pharmaceutical industry and related lobby groups to allow DTCA for prescription drugs in Australia, Canada and the European Union (Mintzes 2002;Mintzes et al., 2003). A recent shift in the interpretation of policy governing this DTCA marketing strategy has seen its partial introduction in some European countries and in Canada. ...
... In the US there has never been a law prohibiting DTCA and the first print DTCA appeared in the early 1980s. During that time and more recently, the US Food and Drug Administration (FDA) developed and implemented strict guidelines for the DTCA of pharmaceutical drugs concerning indications, risks and drug effects , Mintzes, 2002. Similarly, New Zealand has DTCA because of the absence of a prohibitory law. ...
... Similarly, New Zealand has DTCA because of the absence of a prohibitory law. Unlike the US however, New Zealand relies on industry self-regulation, which often results in less risk information appearing in a NZ DTCA than an equivalent US DTCA (Mintzes, 2002). ...
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... Recent studies suggest that DTCA also provides information to groups with lower health literacy, and so may help reduce health inequities (Kaphingst et al., 2005). However, Mintzes (2002) concludes that DTCA may mislead consumers by inflating the likely benefits they will receive from taking a treatment and downplaying the risks and side effects. Toop et al. (2003) extend this point and argue that DTCA creates an over-reliance on medications when behavioural or lifestyle changes may achieve better long-term outcomes. ...
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  • ACAD MED
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