HEALTH POLICY AND ETHICS
Controversies and Capabilities
A Decade of Controversy: Balancing Policy With Evidence in the
Regulation of Prescription Drug Advertising
Dominick L. Frosch, PhD, David Grande, MD, MPA, Derjung M. Tarn, MD, PhD, and Richard L. Kravitz, MD, MSPH
Direct-to-consumer adver-
tising (DTCA) of prescription
drugs has remained contro-
versial since regulations were
liberalized by the Food and
Drug Administration in 1997.
We reviewed empirical evi-
dence addressing the claims
made in the policy debate for
and against DTCA. This adver-
tising has some benefits, but
significant risks are evident as
well, magnified by the promi-
nence of DTCA in population-
level health communications.
To minimize potential harm
and maximize the benefits of
DTCA for population health,
the quality and quantity of
information should be im-
proved to enable consumers
to better self-identify whether
treatment is indicated, more
realistically appraise the ben-
efits, and better attend to the
risks associated with prescrip-
tion drugs. We propose guide-
lines for improving the utility
of prescription drug advertis-
ing. (Am J Public Health. 2010;
100:24–32. doi:10.2105/AJPH.
2008.153767)
THE FOOD AND DRUG ADMIN-
istration (FDA) acquired jurisdiction
over direct-to-consumer advertising
(DTCA) of prescription drugs in
1962. For the next 35 years,
24 | Health Policy and Ethics | Peer Reviewed | Frosch et al.
television advertising was limited
by a requirement that advertise-
ments briefly summarize potential
adverse reactions and contraindi-
cations to drugs. But in 1997 the
FDA issued guidance specifying
that ‘‘adequate provision’’ of in-
formation about drug risks and
benefits could be made by refer-
ring consumers to a toll-free tele-
phone number, a concurrent print
ad, a Web site, or a physician,
making it easier to advertise on
television. The pharmaceutical in-
dustry dramatically increased its
DTCA spending ($4.9 billion in
20071) and shifted the majority of
its budget from print to broadcast
media.2,3
The United States is alone in
permitting DTCA, with the single
exception of New Zealand. Regu-
lation of DTCA recognizes that
prescription drugs differ from
other consumer commodities be-
cause of their inherent risks.
Commercial speech is neverthe-
less subject to significant protec-
tion under US law, leading legal
scholars to conclude that a com-
plete ban of DTCA is unlikely to
withstand litigation testing its
constitutionality.4–6 Policymakers
revisited the issue of DTCA in
2004, after the voluntary market
withdrawal of Vioxx (rofecoxib;
Merck & Co., Whitehouse Station,
NJ), and again during the reau-
thorization of the FDA in 2007.
Signs point to renewed interest in
DTCA regulations in 2009.2–7
But legislators have struggled to
reach consensus about the ap-
propriate role of DTCA in the
health care system. This polarized
policy debate begs the question
of which views have empirical
support.
In effect, DTCA amounts to
a large and expensive uncon-
trolled experiment in population
health. We identified the major
claims made by proponents and
opponents of DTCA and reviewed
findings from relevant empirical
studies, with a focus on peer-
reviewed literature. We then for-
mulated options for legislators to
consider in balancing the consti-
tutional protection of commercial
speech with the need to protect
the public’s health.
CONCEPTUAL
FRAMEWORK
The role of patients in medical
decision making has changed in
recent decades. Patients are no
longer viewed as passive recipi-
ents of medical care, but instead
as active participants who play
American Journal of Public Health | January 2010, Vol 100, No. 1
a key role in making clinical de-
cisions with their health care
providers.8 The expansion of
DTCA stems in part from these
shifts in the conceptualization of the
patient’s role.2 Responding to
critics, the pharmaceutical industry
argues that DTCA plays an impor-
tant role in enabling consumers to
play an active role in medical de-
cision making. Our conceptual
framework builds on this emerging
role of consumers.
As shown in Figure 1, exposure
to prescription drug advertise-
ments can prompt prescription
requests. These requests, medi-
ated or moderated by consumers’
backgrounds (e.g., education and
medical history), can be driven by
ads that include insufficient, inac-
curate, or otherwise misleading
information or alternatively by ads
that include sufficient, accurate,
and balanced information. By
prompting requests for prescrip-
tions, DTCA can promote patient
participation in clinical decisions;
however, the downstream effects
may vary significantly depending
on the quality of the information.
If a request is clinically inappro-
priate, but physicians are unable
(because of lack of knowledge,
time, or other background vari-
ables) or unwilling to correct the

Note. Contextual factors to consider for this model include medical visit type and physician specialty (e.g., primary care, specialty care),
physician marketing exposure, physician’s previous patient communication training, system of care (e.g., health maintenance organization, fee-
for-service), and quality-of-care indicators.
FIGURE 1—Conceptual model of the effects of prescription drug advertising.
patient’s perception, it may lead to
unnecessary and potentially harm-
ful prescribing. On the other hand,
if the request is appropriate, it may
reduce underprescribing and con-
tribute to patient adherence.
Exposure to ads may also have
direct effects on adherence and
medicalization, independent of
promoting prescription requests
by patients. Seeing ads may re-
mind patients about their pre-
scriptions or medical conditions,
thereby potentially contributing to
improved adherence. Ads may
change perceptions about what
constitutes a medically treatable
condition, without necessarily
leading to a prescription request.
The debate over DTCA is mired in
January 2010, Vol 100, No. 1 | American Journal of Public Health
HEALTH POLICY AND ETHICS
competing claims, each of which
we examined.
EDUCATIONAL VALUE OF
ADVERTISEMENTS
DTCA proponents justify the
proliferation of ads by citing their
educational potential.9 Physicians
and patients have been surveyed
about their perceptions of drug ads,
and the content of print and televi-
sion ads has been studied. More
than half of physicians agree that
DTCA educates patients about
health conditions and available
treatments.10–12 In surveys of the
public, nearly 75% of respondents
agree that ads improve their under-
standing of diseases and treatments,13
and more than 40% report using ad
information in their decision-mak-
ing process.14,15 Many physicians,
however, believe that DTCA en-
courages patients to make unwar-
ranted requests, while paradoxically
promoting unnecessary fear of side
effects.11,12 Only a fraction of physi-
cians (1.3%) and consumers (5.4%)
feel that ads provide sufficient in-
formation about drug costs.16
More objective content analyses
of print and television ads find that
most provide the indication for the
product and describe some symp-
toms of the target condition.17–19
Significantly fewer ads provide in-
formation on the drug’s mechanism
of action or the prevalence of, risk
factors for, or causes of the
Frosch et al. | Peer Reviewed | Health Policy and Ethics | 25
condition.17–19 Fewer than one
third of ads provide information
about alternative treatments or be-
havioral changes that could substi-
tute for or complement medica-
tion.17–19 Benefits of drugs are
frequently described in vague
qualitative terms or through the use
of narratives that exaggerate their
magnitude.18,20,21 Television ads
spend significantly less time on
a drug’s risks than on its benefits.
Although risk information is typi-
cally provided in one continuous
stream, benefit information tends to
be interspersed throughout the
ad.19,22 Only a minority of ads
acknowledge variations in product
effectiveness.22
The majority of ad content ex-
ceeds the eighth-grade reading
level recommended for the gen-
eral public,23 potentially exacer-
bating health inequities. Between
1992 and 2002 educational con-
tent in print ads declined, while
promotional content increased.24
Companies typically send supple-
mental materials about products to
consumers requesting them
through a toll-free telephone num-
ber. These more frequently contain
information about drug mecha-
nisms of action and supportive be-
haviors but also often exceed the
recommended eighth-grade read-
ing level.25 On product Web sites,
benefit information is frequently
accessible on the first page, whereas
risk information typically requires
several clicks to access and is often
incomplete.26,27
Consistent with these findings,
a study that assessed consumer
learning following ad exposure
found that participants recalled
more benefit than risk informa-
tion.28 Two experimental studies

suggest that providing the risk in-
formation at the end of an ad
would increase recall.29,30 A study
that assessed rote learning found
inaccurate recall of both benefit
and risk information, suggesting
that current ad formats may not
promote accurate learning.31 In
a series of experimental studies,
participants exposed to an ad con-
taining a table illustrating quantita-
tive benefit information perceived
a lower magnitude of therapeutic
benefits than did those who saw
a standard print ad.32,33 Even
participants with fewer years of
formal education showed good
understanding of tabular quantita-
tive data.33
Although subjective surveys
find that DTCA provides infor-
mation that is valued by the
public, there is insufficient evi-
dence to conclude that ads are an
effective educational vehicle.
More objective content analyses
consistently find that most ads
emphasize benefits over risks
and may be difficult for patients
with average health literacy to
understand. Several small studies
suggest that immediate recall of
information transmitted by ads in
their current format is subopti-
mal. Rigorous experimental evi-
dence indicates that exaggerated
perceptions of benefit can be
corrected with quantitative in-
formation not typically provided
in current ads.
ADVERTISEMENTS
AND THE QUALITY
OF CLINICAL CARE
Studies examining the rela-
tionship between DTCA and the
quality of medical care have
26 | Health Policy and Ethics | Peer Reviewed | Frosch et al.
HEALTH POLICY AND ETHICS
queried whether patients ex-
posed to DTCA have better dis-
cussions and relationships with
their physicians. Surveys of phy-
sicians and patients suggest that
DTCA promotes patients’ partic-
ipation in their medical
care,10,34,35 although it is unclear
whether these subjective percep-
tions result from physician–patient
discussions about advertised
drugs.34 Patients report making
better health decisions,15,36 seeking
more information about cur-
rent14,35 and previously undiag-
nosed35,37 medical conditions, and
having medication-related discus-
sions with their physicians promp-
ted by DTCA.14,15,35 In addition,
most patients and physicians in
nationally representative surveys
agree that DTCA viewing gives
patients more confidence to discuss
health-related concerns with their
physicians.11,13 However, a recent
study found that medication requests
were significantly less common
among patients with low socioeco-
nomic status, and ads promoting
drugs for cardiovascular disease
prevention were less likely to include
ethnic minority characters or to ap-
pear in magazines read by African
Americans, potentially contributing
to health inequities.38–41
Evidence concerning the rela-
tionship between DTCA and the
quality of physician–patient com-
munication is mixed. The majority
of physicians (67%)12 and patients
(54%)15 report that DTCA posi-
tively affects physician–patient dis-
cussions and interactions, and most
agree that DTCA can prompt im-
portant discussions.36,42 However,
1 study failed to show better or
more medication-related discus-
sions following print ad exposure,43
and another indicated that few pa-
tients discover previously undiag-
nosed conditions as a result of
DTCA viewing.44
The evidence is also conflicted
about how DTCA affects satisfac-
tion with the physician–patient
relationship. In nationally repre-
sentative surveys, 39% of physi-
cians and 30% of patients felt that
DTCA interferes with the physi-
cian–patient relationship.11,13 An
industry-funded survey of physi-
cians found that most (82%) do not
believe DTCA causes problems
with their relationships with pa-
tients44; however, in another sur-
vey 89% of family physicians did
not feel that DTCA enhanced their
relationships.10 Physicians reported
more annoyance when presented
with a hypothetical medication re-
quest motivated by DTCA than
they are when the query arises
from a more traditional medical
reference such as the Physicians’
Desk Reference.45 Overall, physi-
cians are less likely than patients to
endorse the positive aspects of
DTCA16 and more likely to worry
that DTCA promotes longer, un-
necessary visits11,16 and inappropri-
ate medication requests.11,12 Patients
may react negatively if their physi-
cian refuses a medication request.
Nearly half of patients in 1 study
reported feeling disappointed about
not receiving a requested medica-
tion, 25% said they would try to
change their physician’s mind or get
the drug elsewhere, and 15% con-
sidered terminating care with their
physician.46
Patients exposed to DTCA may
obtain more appropriate pharma-
cological treatments for their
medical conditions. Surveys re-
veal that the majority of patients
American Journal of Public Health | January 2010, Vol 100, No. 1
and physicians believe DTCA re-
duces underprescribing.11,13 In
a randomized controlled trial, 90%
of standardized patients (actors)
making a brand name medication
request received minimally accept-
able initial care for depression;
56% of patients making no re-
quests received similar treat-
ment.47 In a quasi-experimental
study of depressed patients, patients
in areas with higher DTCA pene-
tration were more likely to receive
pharmacological treatment.48 In
another study, half of the patients
who requested a medication for
a bladder problem were later di-
agnosed with the condition and
prescribed the advertised drug.49
Women exposed to osteoporosis
drug ads were more likely to receive
bone density measurements.50
Some evidence indicates that
DTCA can improve the quality
of care. Surveys find that it
appears to encourage discuss-
ion of therapeutic options, and
limited evidence from random-
ized controlled trials suggests
that it may ameliorate under-
treatment of selected conditions.
However, the overall effects of
DTCA on physician–patient
communication are unclear, and
the effects on quality of care
appear mixed.
EFFECTS OF
ADVERTISEMENTS ON
PATIENT ADHERENCE
Patient nonadherence costs ap-
proximately $100 billion annually
in lost productivity and added
health care expenditures.51 Propo-
nents argue that DTCA increases
patient adherence; however, evi-
dence remains scant.

In a representative survey, 72%
of physicians agreed that ads pro-
mote patients’ adherence to instruc-
tions.11 However, a majority of phy-
sicians (54%) in a pharmaceutical
industry-funded survey disagreed
that they increase adherence.12 A
nationally representative survey of
the public found that 82% of re-
spondents believed ads promote
adherence to physicians’ instruc-
tions,13 but among patients recruited
from physicians’ waiting rooms only
23% indicated they would be more
likely to take an advertised drug.15
Some research has analyzed
claims data for an association be-
tween DTCA spending and per-
sistence of prescribed medication
regimens. Brand-specific ads for
antidepressants had no effect on
treatment duration; however, total
ad spending for all antidepressants
showed a small but significant
association with receiving treat-
ment for at least 4 months.48 Similar
small but significant prescription
persistence effects have been found
for cholesterol-reducing statins.52
High levels of DTCA for statins
were also associated with patients
reaching the least-restrictive low-
density lipoprotein goal recom-
mended by clinical guidelines.53
There is insufficient evidence to
draw clear conclusions about the
effects of DTCA on adherence to
prescribed regimens. However,
the available evidence suggests
that DTCA may have small, ben-
eficial effects on drug adherence.
PROMOTION OF
QUESTIONABLE
PRESCRIBING PRACTICES
A chief concern of critics is the
potential of DTCA to increase
January 2010, Vol 100, No. 1 | American Journal of Public Health
HEALTH POLICY AND ETHICS
inappropriate prescribing, reflecting
both cost and safety concerns.54
Physician surveys find that DTCA
increases prescription volume and
that some of these prescriptions are
clinically inappropriate. Eighty-one
percent of physicians believe that
DTCA prompts medication re-
quests, and one quarter report
resulting changes in their prescrib-
ing habits.16 A survey of physicians
and their patients found that 7% of
patients made a prescription request
and that DTCA exposure increased
such requests.55 Although 78% of
the requests were fulfilled, the pre-
scribing physician judged half of
these prescriptions as possible or
unlikely choices for a similar patient
with the same condition. In another
survey, physicians judged half of
DTCA-prompted requests to be
clinically inappropriate.11 However,
69% of these requests were at
least partially fulfilled, with a small
but significant percentage of these
requests (6%) judged as poten-
tially harmful choices. Physicians
often said they fulfilled such re-
quests to accommodate patients.12
More rigorous evidence mea-
suring DTCA-prompted inappro-
priate prescribing comes from
studies of claims data. Patients in
a California health maintenance
organization who reported expo-
sure to ads for cyclo-oxygenase-2
(COX-2) inhibitors were more
likely to receive a prescription for
a COX-2 inhibitor than for a non-
steroidal anti-inflammatory
drug.56 This study used multiple
measures of appropriateness and
found that ad exposure significantly
increased both appropriate and in-
appropriate COX-2 prescribing. A
study of a large cohort of private
health plan patients found higher
rates of switching to an advertised
brand of proton pump inhibitor
among patients living in television
markets with high DTCA volume
for these drugs.57 The therapeutic
equivalence among members of this
class of drugs raises questions about
the appropriateness of these
switches, because the advertised
brands are more expensive and
therefore increase treatment costs.58
The most rigorous evidence regard-
ing DTCA-prompted prescribing
comes from a randomized experi-
ment.47 Unannounced standard-
ized patients (actors) making
brand requests were the most
likely to receive unwarranted
prescriptions for adjustment dis-
order. However, these requests
also increased the likelihood of
obtaining appropriate prescrip-
tions for major depression.
The limited body of evidence
suggests that DTCA-prompted
prescription requests increase
both appropriate and inappropri-
ate prescribing. Which effect is
greater remains unclear.
PROMOTION OF
OVERDIAGNOSIS AND
MEDICALIZATION
Critics of DTCA are concerned
that it leads to medicalization, the
process by which nonmedical prob-
lems come to be defined as treatable
illnesses, thereby potentially in-
creasing unwarranted diagnoses.59
Critics argue that medicalization oc-
curs as a result of mass marketing
that widens the boundaries of illness
in order to expand markets rather
than improving population health.60
DTCA proponents argue that ad-
vertising helps address pervasive
undertreatment.61
Frosch et al. | Peer Reviewed | Health Policy and Ethics | 27
Case studies of various mar-
keting campaigns have exam-
ined the process and conse-
quences of medicalization. For
example, Paxil marketing cam-
paigns for various anxiety dis-
orders were found to advertise
medicalized feelings of social
discomfort with slogans such as
‘‘imagine being allergic to peo-
ple.’’59(p164) Antidepressant print
ads have been found to contain
incomplete syllogisms, leading
readers to conclude that their
emotional symptoms are treatable
with medications.62 A content
analysis of advertisements found
that DTCA often focuses on con-
ditions that may not be recognized
by consumers as pathological or
treatable.63 The only randomized
experiment that examined medi-
calization found that adjustment
disorder symptoms are more likely
to be treated with medication
when prompted by a DTCA-spe-
cific request.47
Although it is clear that DTCA
appears to medicalize symptoms
previously not defined as illness,
the question of whether a net so-
cial benefit exists is a complicated
cultural and political question not
easily answered through scientific
studies.
BALANCING EVIDENCE
AND REGULATORY POLICY
Table 1 provides a summary of
the evidence supporting the claims
made in the DTCA debate and
identifies where further research is
necessary. Although DTCA carries
some benefits, significant risks are
evident as well, magnified by the
prominence of DTCA. Several
changes in the content of ads could
 HEALTH POLICY AND ETHICS

TABLE 1—Summary of Evidence for Claims Made by Supporters and Opponents of Prescription Drug Advertising to Consumers

Claima Summary of Evidence Strength of Evidence and Future Research Directions

Prescription drug advertisements
are educational
Prescription drug advertisements
improve the quality of clinical care
Prescription drug advertisements
promote patient adherence to
prescribed regimens
Prescription drug advertisements
promote questionable prescribing
practices
Prescription drug advertisements
promote overdiagnosis and
medicalization
More than half of physicians and the public surveyed
agreed that DTCA educates the public about
diseases and treatments.
Content analysis studies found that most DTCA lacks important
information to help consumers make truly informed
decisions about the benefits and risks of prescription drugs.
Ad information often requires a high level of literacy for
comprehension.
Experimental studies found that consumer recall of information
in ads is suboptimal.
In some surveys, physicians and patients agreed that
DTCA promotes patient involvement, increases patients’
participation in their health care, and positively affects
physician–patient discussions.
One study suggested that prescription requests are less likely
among patients from economically disadvantaged groups.
Limited rigorous experimental evidence suggests that
DTCA-prompted requests can enhance diagnostic
sensitivity and treatment provision.
In some surveys, but not in others, the majority of physicians
and patients agreed that DTCA promotes adherence.
Studies of claims data found small positive ecological
(or area level) associations between DTCA spending
and prescription persistence for antidepressants
and lipid-lowering agents.
In some surveys, physicians indicated that they fulfilled
questionable DTCA-prompted patient requests for prescriptions.
Studies of claims data found evidence for inappropriate prescribing
of COX-2 inhibitors and proton pump inhibitors associated with
DTCA exposure.
Experimental evidence suggests that DTCA-prompted
requests increase clinically questionable prescribing
of antidepressants for adjustment disorder.
Case studies of marketing campaigns and content analyses
illustrate how ads expand the diagnostic boundaries of illnesses.
Limited experimental evidence supports DTCA-prompted
medicalization in the context of a mild psychiatric condition.
Physician and patient survey findings reflect subjective
perceptions of the educational value of DTCA, rather
than objective assessments that DTCA increases
knowledge about prescription drugs.
Content analysis studies provide more objective
assessments of the educational potential of DTCA,
but do not reflect what consumers actually learn.
Few studies have longitudinally or experimentally
assessed learning after exposure to DTCA.
The majority of studies examining the effect of DTCA on
the quality of care were cross-sectional surveys assessing
subjective perceptions of physicians and patients.
Few studies used rigorous objective measures to assess
the effects on quality of care.
Nothing is known about the effects of DTCA on health
outcomes.
Survey studies of the effect of DTCA on patient adherence
relied on subjective perceptions of physicians and patients.
No studies directly link individuals’ ad exposure to improved
adherence.
Rigorous evidence concerning questionable prescribing
in response to DTCA-prompted requests is limited to a
small number of therapeutic areas.
Proving medicalization is challenging for researchers.
The effects of expanding diagnostic boundaries on
population health outcomes remain unknown.

Note. COX = cyclo-oxygenase; DTCA = drug advertising to consumers.

a
Additional claims that remain relatively underexplored in the empiric literature include the effect of DTCA spending on resource allocation by pharmaceutical companies (i.e., research versus
promotion), the influence of DTCA on the substitution of generic for brand name drugs, and the interactions of DTCA with direct-to-physician marketing.

maximize their beneficial potential
while minimizing their risks. Al-
though high-quality information
about prescription drugs is itself not
sufficient to ensure appropriate pre-
scribing decisions, it is a necessary
ingredient to improve DTCA-
prompted prescribing. The box on
the next page lists guidelines we
propose to improve the utility of
DTCA in reducing inappropriate
and increasing appropriate
prescribing. Pharmaceutical
companies could use data from
advertisement pretests to dem-
onstrate to the FDA that these
issues have been addressed be-
fore an ad is aired to the public.
Because pharmacological treat-
ments are directed at different
medical conditions, and these con-
ditions vary in the education and
information required to inform
high-quality decisions about their

28 | Health Policy and Ethics | Peer Reviewed | Frosch et al. American Journal of Public Health | January 2010, Vol 100, No. 1
 HEALTH POLICY AND ETHICS

treatment, our proposed guidelines

Proposed Content Guidelines for Prescription Drug Advertisements distinguish between 3 categories:
Am I an Appropriate Candidate for this Prescription Drug?
previously undiagnosed, asymp-
For products targeted at patients with previously undiagnosed, asymptomatic conditions
tomatic conditions (e.g., hypercho-
(e.g., hypercholesterolemia, hypertension):
lesterolemia), previously undiag-
d
Name of condition
nosed symptomatic conditions (e.g.,
d
Prevalence in quantitative terms
major depression), and previously
d
Potential clinical consequences of condition
diagnosed conditions (e.g., anemia).
d
Risk factors or precursors of the condition
For some conditions, more than 1
d
Biological (e.g., race/ethnicity)
of these categories may be appli-
d
Clinical (e.g., comorbidities)
cable in improving the advertise-
d
Family history
ments’ educational potential.
d
Lifestyle and behavioral (e.g., sedentary)
We discern 3 primary goals for
d
Recommended diagnostic or screening tests
DTCA. First, ads should facilitate
For products targeted at patients with previously undiagnosed, symptomatic conditions
the identification of appropriate
(e.g., major depression, overactive bladder):
patient candidates for treatment.
d
Name of condition
The majority of ads produced to
d
Prevalence in quantitative terms
date provide little information that
d
Identification of condition-specific symptoms, including frequency and magnitude of symptoms
would allow consumers to clearly
associated with diagnosis
identify whether the advertised
d
Validated self-administered diagnostic screener, if available
product is indicated for them.18
d
Potential clinical consequences of condition
Including the proposed information
For products targeted at patients with previously diagnosed conditions (e.g., anemia of chronic kidney
in ads could reduce inappropriate
disease, postherpetic neuralgia):
and increase appropriate prescrib-
d
Name of condition
ing. Second, ads should provide
What Are the Health Benefits of This Prescription Drug?
accurate and specific information
For all products:
about the potential benefits of ad-
d
Precise information about absolute risk or symptom reduction to be expected from drug
vertised drugs instead of the current
(as appropriate for drug advertised), including duration of therapy observed in clinical trials,a
qualitative and emotion-driven
drawn from published studies32,33:
portrayals that often suggest mis-
d
Compared to placebo
leadingly dramatic effects. The in-
d
Symptom or absolute risk reduction associated with lifestyle change, including description of
clusion of quantitative benefit data
magnitude of change necessary
from clinical trials has been shown
d
Where possible, including results from comparative (head-to-head) clinical trials
to lead to more realistic consumer
d
Availability of generic alternatives
appraisals of effectiveness, even
What Are the Health Risks of This Prescription Drug?
among those with fewer years of
For all products:
formal education.32,33 Third, ads
d
Risk information, provided in a final separate block of the advertisement that is narratively and
should provide specific quantitative
visually distinct from the remainder of the ad
information about the potential
d
No background music, to reduce distraction from the information
risks associated with drugs.64 Cur-
d
Fact density and pace of information provision not significantly different from the remainder of the ad
rent ads often contain a mismatch
d
Magnitude and frequency of major risks in comparison to placebo64
between visual imagery and verbal
a
Number needed to treat statistics are a potential alternative method for presenting information about drug messages when risk information is
benefits; however, some studies suggest that such statistics may be difficult to comprehend for consumers.65,66 presented. Research has shown that
when visual and verbal messages
are discordant, visual messages
tend to dominate information pro-
cessing, which could lead to

January 2010, Vol 100, No. 1 | American Journal of Public Health Frosch et al. | Peer Reviewed | Health Policy and Ethics | 29

inadequate processing of verbal risk
information.67
All proposed information, in-
cluding product risk information,
should be provided at an eighth-
grade literacy level, to ensure
comprehension by a larger seg-
ment of the population than is
being reached now.28 Consumers
could also benefit from drug cost
information; however, no accurate
way of comparing prices of differ-
ent drugs has been developed
yet.68 Until such data become
available, ads could at minimum
note, where applicable, that generic
alternatives are cheaper.
RESISTANCE TO CHANGE
We anticipate certain responses
to our proposals. Some will argue
that advertisements are too short
(typically 1 minute) to include the
information we propose. However,
Pfizer has recently been running ads
for Celebrex (celexocib; Pfizer, Inc.,
New York, NY) that are 2.5 minutes
long.69 Although it is unclear
whether television viewers pay at-
tention to longer ads, following our
proposed guidelines may not re-
quire ads that are as long as the
recent Pfizer ad. It is also important
to note that our proposals are con-
cerned with the quality as well as the
quantity of information.
Some will likely argue that the
comparative benefit data we pro-
pose including in ads are often
unavailable. Although there are
few direct comparative trials of
different treatment options, both
pharmacological and nonpharma-
cological real-world decisions are
also made in the absence of com-
parative trial data. Ads could com-
municate relevant data from trials
30 | Health Policy and Ethics | Peer Reviewed | Frosch et al.
HEALTH POLICY AND ETHICS
that do not compare the options
directly but do provide some mea-
sure of what is known about the
effectiveness of alternative treat-
ment options. Data should be pre-
sented in a manner that increases
accurate interpretation of the re-
sults by consumers.32,33,70
Finally, critics of our proposals
may contend that physicians are
the learned intermediaries who
should provide consumers with
information about prescription
drug indications, benefits, and al-
ternatives.71 This argument ignores
well-documented realities of the
American health care system. Re-
cent data suggest that the average
visit with a physician lasts be-
tween 16 and 21 minutes.72,73 If
prescription requests are made by
patients during consultations for
other issues, little time is left for the
physician to address misconcep-
tions induced by DTCA. Moreover,
the reliance of the physician pay-
ment structure on satisfaction sur-
veys introduces significant risks
from denying patient requests. The
negative effect of denying requests
on the therapeutic relationship is
well-documented—patient satisfac-
tion declines and physician switch-
ing increases46—although it may be
possible to mitigate such effects by
involving patients in the decision-
making process.74
It is unclear how the courts
might rule on our proposed
guidelines if they were to be con-
tested on First Amendment
grounds.6 However, we believe
these changes would be positive for
both consumers and industry, per-
haps reducing the likelihood that
they would be challenged.
DTCA amounts to a large and
expensive uncontrolled experiment
in population health, which to date
shows decidedly mixed effects. The
evaluation of the effects of this ex-
periment would be aided if the in-
dustry made the times when ads
were aired in different media mar-
kets publicly available. Researchers
could use these data to evaluate the
effects of DTCA on drug expendi-
tures and health outcomes with
much greater precision, potentially
benefiting both industry and regu-
lators. Similarly, our proposed
guidelines should also be subject
to a trial period followed by care-
ful evaluation, to ensure that
changes in ad content have the
intended beneficial effects on
population health.
Following the market with-
drawal of Vioxx, several phar-
maceutical manufacturers an-
nounced a voluntary time-limited
moratorium on advertising new
products, although it is unclear if
this has been implemented as
promised.75 The industry should
be given the opportunity to imple-
ment our proposed changes
voluntarily. If these changes are not
forthcoming, legislators should
consider changing existing FDA
regulations to ensure that DTCA
achieves its full potential for maxi-
mizing population health. j
About the Authors
Dominick L. Frosch is with the Division of
General Internal Medicine and Health
Services Research, Department of Medicine,
University of California, Los Angeles.
Dominick L. Frosch and David Grande are
with the Leonard Davis Institute of Health
Economics, University of Pennsylvania,
Philadelphia. David Grande is also with the
Department of Medicine, University of
Pennsylvania, Philadelphia. Derjung M.
Tarn is with the Department of Family
Medicine, University of California, Los
Angeles. Richard L. Kravitz is with the
American Journal of Public Health | January 2010, Vol 100, No. 1
Division of General Medicine, Department
of Internal Medicine, and the Center for
Healthcare Policy and Research, University
of California, Davis.
Correspondence should be sent to Dom-
inick L. Frosch, Department of Health
Services Research, Palo Alto Medical
Foundation Research Institute, Ames Bldg,
795 El Camino Real, Palo Alto, CA
94301 (e-mail: froschd@pamfri.org). Re-
prints can be ordered at http://www.ajph.
org by clicking the ‘‘Reprints/Eprints’’ link.
This article was accepted April 11,
2009.
Contributors
D. L. Frosch, D. Grande, and D. M. Tarn
completed the literature review. All au-
thors participated in writing the article.
Acknowledgments
D. L. Frosch is supported by a Robert
Wood Johnson Foundation (RWJF) In-
vestigator Award in Health Policy Re-
search. D. Grande was supported in part
by the RWJF Health and Society Scholars
Program. D. M. Tarn is supported by
a University of California, Los Angeles
(UCLA) Mentored Clinical Scientist De-
velopment Award (5K12AG001004)
and by the UCLA C. D. Pepper Older
Americans Independence Center, funded
by the National Institute of Aging (5P30
AG028748). R. L. Kravitz is supported by
a Mid-Career Research and Mentoring
Award from the National Institute of
Mental Health (K24MH072756).
Human Participant Protection
No protocol approval was required be-
cause no human participants were in-
volved in the study.
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AJPH.2008.144097)
SPORTS SPONSORSHIP HAS
been part of tobacco promotion
since the industry invented base-
ball cards to associate cigarettes
with sport,1 and it continues to
represent a challenge for tobacco
control worldwide.2–5 Sports spon-
sorship is associated with smoking
behavior4 and appeals to youths,2
maintains presence on television in
restricted markets,3,6,7 and recruits
American Journal of Public Health | January 2010, Vol 100, No. 1
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third-party allies to fight marketing
restrictions.8
Rodeo originated in the 1800s.
The Cowboy’s Turtle Association
was formed in 1936 and became
the Professional Rodeo Cowboys
Association (PRCA) in 1975.9 Cig-
arette companies explored rodeo
sponsorship during the early 1970s,
when tobacco advertising was
banned from broadcast media in
the United States.3,5,6,10 The US
Smokeless Tobacco Company
(USST)11,12 has sponsored the PRCA
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