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INDUSTRY AND ONCOLOGY
has been “lackadaisical.” 21 Notably, the United States is one The ethical implications of DTC advertising are complex. 42
of only two countries in the world that permits such advertising.
Furthermore, a recent paper from the other country being, and distributive justice by informing and empowering
On one hand, advertising may promote autonomy, well-
that permits such advertising—New Zealand—calls for that patients, improving quality of care, and promoting responsiveness
to patients’ needs and values. 43-45 This is most likely
country’s policy to be reviewed, since such advertising “exposes
patients to unnecessary adverse effects and iatrogenic when the advertisement is not itself disguised in educational
programming or celebrity interviews, 46 when the
harm, and increases costs for the health care sector through
the prescription of expensive branded medication.” 22
product being advertised has clear indications, and when a
Although direct-to-consumer advertising may be protected
by a constitutional right to free speech in the United vise the patient and correct any misunderstandings. On
physician without industry relationships is available to ad-
States, 23 the U.S. Constitution would presumably not prohibit
requirements analogous to those included in the Sun-
even disruption of the physician–patient relationship. 47,48
the other hand, advertising may also lead to confusion and
shine Act and the Final Rule regarding transparency reports The very statement, “Ask your doctor about X” implies
of relationships between companies and health care providers.
For example, Congress could require public dissemina-
information, potentially jeopardizing patients’ trust in
that one’s doctor requires a prompt to provide necessary
tion (e.g., in a database) of the costs of drugs marketed their physicians. As noted above, DTC advertising has direct
costs, and it can also increase the costs of the health
directly to consumers, as well as the overall costs of the marketing
and advertising of such drugs. In addition, Congress care encounter or cause harm by distracting from other,
could also require that all print ads aimed at a consumer audience
include detailed information about drug costs, given
more appropriate subjects for discussion.
Although there is some evidence that DTC advertising may
the increasing importance of fınancial toxicity related to expensive
drugs. 24 Similarly, television and radio ads could also
improve patient education and physician–patient communication
necessary for truly shared decision making—and it
be required to devote adequate time (e.g., 15 seconds) to discussing
this increasingly important issue, with the goal of re-
might even help mitigate health disparities by encouraging
patients of low socioeconomic status to seek care—the primary
goal of advertising is to increase utilization.
ducing demand for expensive drugs that may be only
marginally better than much cheaper alternatives.
49,50 One
study found a 1% increase in prescription drug spending for
every 10% increase in DTC advertising. 51 In some circumstances,
this increased use may be appropriate, such as that
DIRECT-TO-CONSUMER ADVERTISING
observed in one study of the effect of aromatase inhibitor advertisements.
Since 1962, the FDA has had regulatory authority over prescription
drug advertising. 25 Although professionals have
52 Nevertheless, to avoid the possibility that advertising
might compromise health care quality by leading to
historically been the primary target of advertisements, DTC
overuse or misuse (rather than correction of underuse), the
advertising began as early as the 1980s, primarily in print
form. DTC advertising expanded dramatically after 1997,
physician’s role as an unbiased intermediary and counselor is
when the FDA issued draft guidance on broadcast advertisements
26 that was later fınalized in 1999. 27 Industry spent ap-
critical. 53 Unfortunately, the proliferation of ties between
physicians and industry discussed above can compromise
proximately $150 million on DTC advertising in 1993, which
physicians’ ability to play this important role. 54 DTC advertising
is particularly problematic when coupled with
rose to $1.1 billion by 1997, reached $3.2 billion by 2003,
peaked at $4.9 billion in 2007 (also the peak of overall promotional
spending for pharmaceutical products), and was terpretation.
the absence of an unconflicted provider to help in its in-
$3.9 billion in 2011. 28,29
As detailed in other sections of this manuscript, industry
DTC advertising has substantial influence on medical practice
and affects drug utilization. 30-34 A public survey revealed as unbiased intermediaries are broad in range and scope. Re-
relationships that can affect the ability of physicians to serve
that 30% of respondents had initiated conversations with cent regulations to mandate disclosure have stemmed from
their physicians about a medicine they saw advertised, and, of the recognition that industry was increasingly offering physicians
not only samples, gifts, dinners, and junkets, but also
these, 44% reported actually receiving a prescription for the
drug as the outcome of the conversation. 35 Many DTC advertisements
target patients with cancer, 36 and a survey found speakers’ bureau membership, ghostwriting services, and
consulting fees, honoraria for speaking engagements and
that 86.2% of oncology patients reported awareness of such substantial fınancial support for research. 55,56 Although the
ads. 37 In another survey, 94% of oncology nurse practitioners bias that results from this entanglement with industry may be
reported having received medication requests prompted by unintentional and unconscious, and most physicians fırmly
DTC ads, and 40% indicated that they received one to fıve believe that they themselves cannot be influenced in this way,
such requests per week. 38 DTC advertising relevant to oncology
extends well beyond the marketing of prescription drugs, an effect. 57 Thus, although ethical concerns about the poten-
considerable evidence suggests that such ties do indeed have
to include advertising for genetic testing and medical imaging—other
industries with which physicians often have of concerns related to DTC advertising, they take on heighttial
effect of these relationships exist even outside the context
ties. 39-41 ened importance in this light. 58
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