1

Risks and benefits of direct to consumer advertising on patient -

provider relationships

Ashish Parekh, BS, MS, Candidate, Doctor of Pharmacy, Sullivan University College of

Pharmacy, Louisville, KY, USA

Roland Marcus, BS, Professional Research Assistant, University of Colorado Health

Sciences Center, Denver, CO, USA

Melissa Roberts, MS, CMA, Senior Research Associate, Lovelace Clinic Foundation,

Albuquerque, NM, USA

Dennis W. Raisch, PhD, MS, RPh, Professor, PEPPOR (Pharmacoeconomics,

Epidemiology, Public Policy and Outcomes Research), College of Pharmacy, University

of New Mexico, Albuquerque, NM, USA

Direct to consumer advertising (DTCA) is a potentially powerful source of consumer

health information. Currently, it is only permitted in the United States (US) and New

Zealand.1 Regulatory agencies (European Medicines Agency and Health Canada) in

other countries have not allowed it due to concerns regarding the impact on public

health.2 DTCA covers both prescription and over-the-counter (OTC) products advertised

through television, radio, internet and print media. The Food and Drug Administration

(FDA) in the US began regulating the advertising of prescription drugs in 1962. In 1997

the FDA issued guidelines regarding the information presented within DTC advertising,

which resulted in substantial increases in broadcast DTCA.1 Total spending on

pharmaceutical promotion grew 62% from $11.4 billion in 1996 to $29.9 billion in 2005.

Spending on DTC advertising represented 14% of this total and grew 330% during this

period to $4.4 billion.3 DTCA spending increased to $4.8 billion in 2007 and has

remained near these levels since.4 The FDA does not review each message prior to

release. Guidelines are still being developed in an effort to maximize benefits and

minimize risks associated with DTCA. Since DTCA’s inception, there have been a

number of studies on the effects of DTCA on consumer behavior, physician behavior,

health care delivery, health care utilization, risks and benefits, and health outcome in

the US.

2

DTCA can impact multiple facets of health care including: alerting consumers to

potentially beneficial treatments; increasing the number of patients taking a needed

and well tolerated medicine; increasing or decreasing the number of patients taking

medications without medical benefit ; reducing morbidity and mortality rates; and either

increasing or reducing health care costs.5

The overall assumption has been that DTCA directly changes, for better or worse, the

patient-provider visit.6,7 According to three FDA surveys performed from 1999 to 2002,

physicians reported that DTCA had the following four beneficial effects. It improved

discussions with patients, increased understanding of their disease and treatment, and

increased the likelihood that patients were compliant taking their prescribed medications

as directed. Finally, it enhanced the diagnosis of new conditions.8 DTCA is also

considered helpful for patient education which is likely a driver of the perceived effects

listed above. In addition, it is perceived that DTCA gives patients more control over

their care and well-being by prompting patient visits to providers and encouraging a

more interactive clinical visit.9,10

However, there is still a lot of controversy on the interpretation of study results and

whether the overall outcome from DTCA is positive or negative.6,8,9,11-13 Within the

reviewed studies, there is a definite difference of opinion on the impact of DTCA with

respect to the patient-provider relationship among both groups: patients and providers.

One facet of controversy about DTCA’s effects is that it could negatively affect patient-

provider interactions due to DTCA increasing patient requests for unneeded or

expensive medications. Some health care providers object to the resulting demands

from patients for certain brand name drugs. Not only may the requested brand be

inappropriate for their condition, or be less effective than advertised, it could cause side

effects. Furthermore, a provider may end up prescribing the requested treatment

without knowing all the risks and benefits for the patient in question or fully discussing

risks and benefits with the patient. The newest drugs do not have the same long track

records of effectiveness and safety that an older treatment has. DTCA may not

3

adequately explain treatment options and may give consumers a false sense of security

regarding the safety of these advertised treatments. Furthermore, it is argued that

DTCA increases utilization and health care costs by focusing primarily on the newest

and most expensive drugs. This and other ongoing evaluations of the effects of DTCA

on the patient-provider relationship merit further discussion and are explored in this

review.

The purpose of this literature review is to summarize and assess physician and

patient/consumer perceptions regarding DTCA sentiment on these issues.

Method:

We used the ISI Web of Knowledge (Thomson Reuters) database for our search, which

includes the Web of Science databases covering almost 10,000 journals. Included

databases are the Science Citation Index Expanded (1899-present), Medline (1946 –

present), the Social Sciences Citation Index (1898-present), and the Arts & Humanities

Citation Index (1975-present). We felt that while we may miss some articles in utilizing

only this database, the journals represented in the database are well-regarded peer-

reviewed journals and should provide a substantive representative sampling of the

extant literature. Our search terms were the phrase “direct to consumer” and

“advertising” in combination. We included publications in English, published after 1995

that specifically included analyses of patient/consumer and physician attitudes towards

DTCA. To limit our findings to research results from original data collection, we

excluded letters, editorials, and news items. Meeting abstracts were also excluded due

to the lower level of peer-review and lack of sufficient data. In addition we excluded

articles that focused on other aspects of DTCA without describing patient and/or

provider attitudes.

Results:

Our search was performed in September 2010. One person of the team performed the

search. The search yielded 390 citations (See Figure). There were 130 letters,

editorials, meeting abstracts and news items, reducing our count to 260 items. Refining

4

our list to only publications in English and published 1995 or later, reduced the count to

250 items. Among the 250 items, we reviewed the abstracts for 208 citations that

pertained to publications from the United States. Table 1 shows a summary by

publication year of the reviewed abstracts. Publications were most frequent during the

years 2004-2008. In reviewing the abstracts we looked for primary analyses of

patient/consumer or physician attitudes toward DTCA, finding 65 abstracts that we

further reviewed. Of the 65 articles we excluded 35 articles. The remaining 30 articles

comprised 18 articles that reviewed patient attitudes,14-30 9 that reviewed physician

attitudes,31-40 and 3 that reviewed both.39,41,42 Overall results for articles are shown in

Table 2, the details of which are discussed in the following sections. Study findings

described by the papers in our review have been identified and summarized in Table 3.

Positive Impact for DTCA on the patient-provider relationship

Better discussion with patients

A common perception in reviewed studies was that patients are more informed as a

result of DTCA and that this has improved the patient-provider interaction. In a study

with over 2500 patient responders, 14% of respondents disclosed health concerns as a

result of DTCA and 6% requested preventive care.29 Stratification of the responding

group showed higher rates for patients with chronic conditions or who were taking 3 or

more medications. Patients with chronic conditions were positively affected by DTCA

because they have a better understanding of the disease in terms of prognosis and

management reducing uncertainty and making them more involved in their health care.

In fact, these subjects have reported improvements in their perception of health to a

level equal to those who had no chronic conditions.43 Many of these discussions are

cited in studies as discussions that would not have occurred without the impetus

provided by DTCA. Although data from one study revealed that DTCA is likely to

increase request rates of the drug category and brand name version, these requests

typically lead to some form of discussion about the disease state that would not have

been present otherwise.37

Education

5

Proponents of DTCA believe that the practice helps to educate patients, giving them

more control over their care and improving well-being.7,9,10 Supporters also feel that

patients are more educated and feel empowered to seek help for medical

conditions.20,23 In several reports, DTCA was described as a way to bring patients into

the office to talk about rarely discussed conditions.23,33 However, patients tend to be

more likely to view DTCA as educating patients than physicians. For example one study

of physicians and patients found 44% of patient respondents believed DTCA helped to

educate patients, while only 32% of physicians did.41 Other separate studies show 55%

of physicians and 69% of patients thought DTCA encouraged patients to seek treatment

they would not have gotten otherwise.29,36 Lastly, DTCA may benefit minority

populations. In another survey of physicians, it was believed that minority populations

benefited greatly from education prompted and provided by DTCA.35 This perception

was increasingly seen over a five year period.

Patient more likely to take prescribed drugs

DTCA has been suggested to help improve patient compliance with drug regimens in

addition to increasing the likelihood of having patients get their prescriptions reordered

and continuing their regimen. Two surveys found that physicians believe that DTCA

exposure encourages patients to take a more active role in their health care as well as

follow their prescribed regimen more accurately.33,35 A study of over 1000 physicians

found 72% saw DTCA as having a positive impact in encouraging patient compliance of

treatment or advice.36 Separately, in a study of over 2500 patients, 81% saw DTCA as

having a positive impact in encouraging patient compliance of treatment or advice.29

DTCA appears to encourage compliance with physician-prescribed treatment regimens.

A study conducted by a pharmaceutical company from June 2001 found that the

percentage of patients with diabetes, depression, elevated cholesterol levels, arthritis,

or allergies who continued with therapy after six months was substantially higher when

the patient asked for a medicine after being prompted by DTCA than when the patient

was given a prescription for a medicine without such prompting.9 In a survey, 22 percent

of consumers said direct-to-consumer advertising made it more likely they would take

6

their medicine regularly. The authors concluded well informed patients comply better

with long term treatment than those who are not.6

All of the above studies demonstrate that both physicians and patients firmly believe

that exposure to DTCA has improved this aspect of the clinical relationship.

New conditions diagnosed

DTCA can help improve public health by encouraging more people to talk with health

care professionals about health problems, particularly under-treated conditions such as

high blood pressure and high cholesterol. Also, DTCA can help to remove the shame

that accompanies diseases that in the past were rarely discussed, such as erectile

dysfunction or depression.7

A study that evaluated diagnosis as a result of DTCA found 25% of patients that

initiated a clinical visit due to DTCA exposure, received a new diagnosis of which almost

half were considered high priority.30 These conditions included reflux disease, arthritis,

diabetes, and high cholesterol. For chronic diseases, especially those with high

prevalence that can be treated with prescription drugs, the consequences of not seeking

appropriate treatment can affect not only the patient, but also the family and society. For

example, untreated diabetes can lead to blindness or chronic kidney disease. Non

treated high cholesterol can lead to heart attack or stroke, while cholesterol-lowering

drugs can reduce risk by 30% approximately.9

DTCA encourages members of the public, particularly those of low socioeconomic

status, who may not receive regular medical check-ups, to seek medical care. It

encourages people to disclose health concerns to their doctor, and enhances some

patients’ sense of confidence and control during a visit.9,14,17 A patient survey found that

14% of respondents were driven to discuss conditions with their physician and that the

effect was larger for patients with lower socioeconomic status.29 DTCA may also help

consumers to recognize symptoms and encourage them to seek appropriate care.44

7

Negative Impact for DTCA on the patient-provider relationship

Unnecessary increased utilization

It is also suggested that DTCA could increase utilization and health care costs by

focusing on only the newest and most expensive drugs, could potentially result in

adverse health outcomes, and give consumers a false sense of security regarding the

safety of advertised drugs. Some health care providers object to the resulting demands

from patients for certain brand name drugs that may be inappropriate for their condition,

are more expensive than other options, have side effects of which the patient is

unaware, or are less effective than advertised. One study tried to quantify the increased

utilization due to DTCA with a survey of patients.29 Results show that 5% made

requests for a test, medication change or referral and 3% received the requested

intervention. Although this is not a large percentage, it merits consideration based on

the overall number of patients it implies. A real-time, point of care survey, similarly found

3.5% of patients requesting utilization based on DTCA exposure.38 Segregated to

private practices, this rate was 7.5%. Compared to a previous real-time point of care

survey, this rate was half what it was 5 years prior, indicating a potential decreasing

trend of requests related to DTCA. To explore increased utilization further, a study used

COX-2 inhibitors to describe utilization of requests due to DTCA exposure.45 In this

study, 78% of patients who experienced some form of DTCA asked for and were

prescribed COX-2 inhibitors as compared to 43% of all other patients. People who saw

specialists were twice as likely to receive prescriptions. A maximum of 67% of those

prescribed were deemed appropriate given many factors including risk of

gastrointestinal bleeding. A separate study of physician opinions corroborates this

finding, as 49% of respondents deemed prescription requests as inappropriate with a

stunning 69% fulfilling these requests.36 That translates to 1/3 of all requests being

fulfilled by physicians even though deemed inappropriate. Propagated throughout the

health care system, costs directly related to increased utilization associated with DTCA

could be significant.

Diminished time evaluating a patient

8

Providers are under pressure to limit the time devoted to office visits and to increase

their productivity in terms of numbers of patients seen, but many health care providers

would prefer to spend more time on diagnosis and treatment and less time convincing

patients they do not need advertised drugs.46 Multiple studies in this survey support this

argument. One study of over 700 physician perceptions found that DTCA increases

patient requests for specific medications and therefore changes the patient expectations

of prescribing.39 This same group of physicians believe that DTCA is lacking in

information regarding cost, alternative treatments and adverse effects, which they must

address during clinical visits. Two additional studies report 39% of physicians and 38%

of patients view requests deriving from DTCA as damaging to the efficiency of the

visit.29,36

Impede doctors’ effectiveness

Some health providers consider that with exposure to DTCA, patients may withhold

information from their doctors or even attempt to self-treat themselves with over-the-

counter and alternative medicines, both of which lead to non-optimal outcomes. Aiming

prescription drug ads at consumers can affect the "dynamics of the patient-provider

relationship," and ultimately, the patient's quality of care. It has also been seen that

DTCA can motivate consumers to seek more information about a product or disease,

however physicians need to help patients evaluate health-related information they

obtain from DTCA.8 An in depth study evaluating physician responses to patient

requests for information as a result of DTCA, showed a statistically significant negative

impact on physician willingness to answer 145 questions and provide additional

information which clearly can impact the effectiveness of the clinical visit.47

Misinformation

The design and implementation of DTCA has been perceived as misleading, affecting

negatively the relationship between patient and physician.37 DTCA has been accused of

lacking educational value, misleading consumers into thinking that they have conditions

that can be cured with the advertised medications.39,48 As a result, doctors may have to

9

spend more of the clinical visit addressing misunderstandings of drug and treatment

options.35,41

Some providers consider that DTCA rarely includes additional alternative information on

lifestyle changes that could be as important as the taking of medication.49 For some

patients, weight loss, exercise, and healthy diets can be as beneficial to maintaining

health as taking cardiac medication. Thus, opponents of DTCA believe that lifestyle

changes should be addressed by the physician, rather than depending solely on the

action of advertised specific medications.5,7

For many of the reasons described above, DTCA is seen to have both positive and

negative effects with multiple studies describing in different ways which facets of the

relationship are affected. As an example, one study summarized physician perceptions

of the effect of DTCA on the clinical experience. Physicians saw 24% of visits as

positive, 66% neutral and 10% as negative.38 Table1 highlights the differences between

Patient and Physician view while also indicating the total number of articles which

contained the Beneficial and Detrimental aspects of DTCA. The three most beneficial

aspects of Direct to Consumer Advertisement were found to be: Education of

Disease/Awareness of Drugs, Discussion, and Disease Detection. Patients have a slight

positive view and physicians have a slight negative view. The benefits of DTCA to the

patient- physician relationship in the order most often cited are education of disease and

awareness, discussion, disease detection and compliance. Detrimental effects in the

order most often cited are misinformation, specific drug requests, unnecessary

utilization, negative impact on clinical visit, inappropriate medication use and diminished

evaluation time. Overall, the effect of DTCA on the patient provider relationship is

viewed as a positive one. Reasons for the mixed view can be used to provide the

framework to determine modifications to DTCA for maximum benefit and minimum

negative impact.

Future directions for DTCA to improve the patient-provider relationship

10

Direct-to-consumer advertising does not supersede the physician–patient relationship;

its effect is rather to encourage an informed discussion between patient and physician.

As has been discussed in FDA hearings since the introduction of DTCA, and with the

advent of the ”Bad Ad“ program, DTCA could be monitored and evaluated closely to

ensure a balanced message was being delivered. These investigations will allow

changes to DTCA that limit the negative impact as well as enhance the patient-provider

relationship. A recent study showed that only 18% of print ads evaluated in a one month

period were compliant with FDA guidelines with over 50% of the ads showing serious

risks of the medication.50 Currently the FDA sponsors a website that was created in

collaboration with EthicAd containing materials for consumers to educate them on drug

advertising.51,52 Although utility of the internet to locate health information is rising

rapidly, a website alone may not be the sole suitable medium for many individuals. For

example, highly targeted, practice-specific posters and pamphlets placed in doctor

waiting rooms or pharmacies combined with digital media placement may expand the

FDA's outreach to a broader audience.

In order to minimize negative effects of DTCA, information must be accurate, not

misleading and should reflect the balance between risks and benefits. Information

should be designed to educate consumers and to refer patients to health professionals

for further discussion as to whether the drug is appropriate, after their condition has

been evaluated. DTCA should also be designed to clearly explain potential risks and

side-effects, discourage self-diagnosis and self-treatment, as well as promote healthy

lifestyle practices.

The consumer should be strongly encouraged to discuss medications with health care

practitioners as the health care provider is often a better source of information and less

biased than DTCA regarding the most suitable medicines. Health care providers should

also know that patients are increasingly seeking information through multiple channels

regarding new therapies and be prepared to discuss these therapies as a part of the

consultation.

11

Limitations

Our article is a review of the extant published studies concerning patient and

practitioner attitudes about DTCA and its impact on the patient provider relationship,

based upon the search methodology described. A more thorough search of

unpublished literature would undoubtedly generate more information than we have

presented here, but the information would not have been subjected to peer review. We

believe that our search resulted in a comprehensive set of the published articles on this

topic. The articles encompassed surveys of both primary and specialist physicians and

a wide range of patient demographics.

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16

Table 1 Publication Year for Reviewed DTCA Abstracts

Publication Year

Record Count

% of 208

2010 6 2.9 %

2009 16 7.7 %

2008 24 11.5 %

2007 29 13.9 %

2006 20 9.6 %

2005 18 8.6 %

2004 25 12.0 %

2003 15 7.2 %

2002 13 6.2 %

2001 12 5.8 %

2000 11 5.3 %

1999 5 2.4 %

1998 7 3.4 %

1997 5 2.4 %

Table 2 Reviewed Articles: Summary

Overall Summary Positive Negative Mixed

Impression Total

Overall Impact

Physician View 3 5 4 12

Patient View 6 2 13 21

Aspect #

Articles #

Articles Total

Beneficial Aspects

Discussion 27 0 27

Education of Disease/Awareness of Drugs 28 1 29

Compliance 6 1 7

Disease Detection 20 1 21

Other 3 0 3

Detrimental Aspects

Unnecessary increased utilization 13 0 13

Leads to patients specifically requesting drug 22 0 22

Inappropriate use 9 1 10

Misinformation / Not enough information 23 0 23 Diminished patient evaluation time / increased visit time 7 1 8 Impede doctors effectiveness / negatively impact doctor/patient relationship 10 4 14

17

Table 3 Reviewed Articles: Detail

Overall Impact Benefits Risks Respondents

Author, Pub Year

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Old

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Abel, 2009 Neg Y Y Y Y Y Y Y M

An, 2008 Pos Y Y Y Y M

Bell, 1999 Pos Y Y Y Y Y M

Bell, 1999 Mix Y Y Y Y Y Y Y Y M

Bozic, 2007 Mix Pos Y Y Y Y Y Y Y Y S M

Burak, 2000 Mix Y Y Y Y Y Y Y

Choi, 2007 Mix Y Y Y Y Y Y Y M

Datti, 2006 Mix Y Y Y Y Y Y M

DeLorme, 2006 Mix Y Y Y Y Y Y Y Y Y M

DeLorme, 2007 Mix Y Y Y Y Y O

DeLorme, 2009 Mix Y Y Y Y Y Y Y O

Deshpande, 2004 Pos Y Y Y Y Y Y Y O

Fortuna, 2008 Neg N Y Y Y M

Herzenstein, 2005 Mix Y Y Y Y Y M

Huh, 2004 Mix Y Y Y Y Y Y M

Huh, 2007 Neg Y Y Y Y Y Y M

Kon, 2008 Mix Mix Y Y M M

Lee, 2007 Mix Y Y Y Y Y M

Lipsky, 1997 Neg Y Y N Y Y Y P

Marinac, 2004 Mix Y Y Y Y Y O

Menon, 2003 Mix Y Y Y Y Y Y M

Mintzes, 2003 Neg Y Y Y Y Y Y Y P

Morris, 2007 Pos Y Y Y Y Y Y M

Murray, 2003 Mix Y Y Y Y N M

Murray, 2004 Pos Y Y Y N N M

Parker, 2003 Mix Y Y Y Y Y Y Y Y Y M

Parnes, 2009 Pos Y Y Y N P

Robinson, 2004 Neg Neg Y Y Y Y Y Y M M

Weissman, 2003 Pos Y Y Y N M

18

Weissman, 2004 Pos Y Y N Y Y Y N P

Figure. DTCA Literature Review Flow Diagram

Excluded (n= 130) Letters, editorials, meeting abstracts, news items (n=130) Non-English, earlier than 1995 (n=10) Non-U.S. studies (n=42 )

Articles Reviewed (n= 65)

Abstracts Reviewed (n= 208)

Excluded (n= 143) Review articles Studies not of patient/practitioner attitudes toward DTCA

Excluded (n= 35) Aspects other than patient/practitioner attitudes (n=15) Impact of advertising expenditures (n=7) Physician training (n=4) Hypothetical situation studies (n=4) Duplicate study summaries (n=2) Article not obtainable (n=2) Literature review (n=1)

Articles Included (n= 30)

Assessed for eligibility (n= 390)