Evolution and Impact of Direct-to-Consumer Pharmaceutical Advertising

How many times have you stayed in bed on a Sunday morning binge watching the

investigative sleuthing of Mariska Hargitay on CBSs Law and Order: SVU only to be inundated

with advertisements for erectile dysfunction during every other commercial? I used to think I was

exposed to unsolicited drug advertisements because CBS had a personal vendetta against me, but

actually, the average American television viewer is exposed to at least nine drug advertisements a

day, totaling to roughly sixteen hours per year.1 Advertisements that are an effort (usually via

popular media) made by a pharmaceutical company to promote its prescription productions

directly to patients are called Direct-to-Consumer Pharmaceutical Advertising (DTCPA) and they

have been rapidly increasing over the past several decades.2 The United States is one of only three

nations, alongside New Zealand and Brazil, to allow this form of advertising to its citizens. DTCPA

are now the most prominent type of health-related communication that the public encounters, and

as such, has impacted the field of public health in more ways than one.3 This paper will explore

the evolution of DTCPA as well as use the impact DTCPA has had on the drug use for stigmatized

illnesses.

There are three types of DTCPA: Product claim ads, the most common type seen today,

Reminder ads, and Help-seeking ads. A reminder ad names a drug, dosage form, and possibly

cost, but not its uses, while a help-seeking ad describes a disease or condition but doesnt

mention a specific drug that treats it.4 The major difference between a reminder ad, help-seeking

1
Ventola, C. Lee, MS. "Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic?"
Pharmacy and Therapeutics, October 2011, 669-84.
2
Ibid.
3
Ventola, C. Lee, MS. "Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic?"
Pharmacy and Therapeutics, October 2011, 669-84.
4
Ibid.

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ad, and a product claim ad is that the latter must include a fair balance and brief summary

statement in the broadcast. Fair balance requires that product claim ads give a "fair balance" of

information about drug risks as compared with information about drug benefits. This means that

the content and presentation of a drug's most important risks must be reasonably similar to the

content and presentation of its benefits and brief summary is the technical name for the detailed

information that appears in ads for prescription drugs.5 A further historical analysis of DTCPA

and its growth is needed to begin to explain its impact on public health today.

The history of DTCPA begins with the increased authority given to the Food and Drug

Administration (FDA) by the United States Federal Government in 1938. In 1938, the Federal

Food, Drug, and Cosmetic Act was passed which gave the FDA the authority to approve

pharmaceutical products that were to be marketed to consumers. Since then, the FDAs Division

of Drug Marketing, Advertising, and Communications has been responsible for the regulation of

DTCPA.6 However, the first DTCPA was not broadcasted until 1983 when Boots Pharmaceuticals

promoted Rufen, a lower priced ibuprofen. With this new development, in 1985 the FDA declared

that DTCPA could only be Reminder Ads and Help-Seeking Ads, but not Product Claim Ads. These

regulations, however, became much less strict when in 2004 the FDA allowed DTCPA that were

product claim ads to include a less comprehensive simplified brief summary instead of requiring

product claim ads to include the previously required fair balance and brief summary.7 The

combination of lax regulations, the cultural shift wherein people became more active in their

5
Center for Drug Evaluation and Research. "Prescription Drug Advertising - Drug Advertising: A Glossary
of Terms." U S Food and Drug Administration Home Page.
6
Ventola, C. Lee, MS. "Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic?"
Pharmacy and Therapeutics, October 2011, 669-84.
7
Ibid.

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medical decisions, as well as the average American watching more television all contributed to the

rapid growth of DTCPA.8

This growth was seen in the increased expenditures for DTCPA, the quantity of DTCPA

broadcasted, and the positive influence it had on sales for the drugs that were advertised. For

example, in 1980 the total expenditures on DTCPA was $12 million; in 2009 that number had

reached $4.5 billion. The impact DTCPA had on sales of the advertised drug were enormous: with

every one dollar spent on DTCPA, sales for the advertised drug would increase by an estimated

$2.20 to $4.20.9 Another contributing factor to the rapid growth of DTCPA was many top-selling

drugs transitioning from prescription to over-the-counter (OTC) status.10 This would take away

the physician from the equation, thus leading to higher sales because patients could make the

decision to buy a drug on their own. This became increasingly prominent with technological

change spurring an increase in health information seeking and self-treatment; by 2000, more

than 26,000 websites were related to health and by 2003, 66 percent of internet users said they

went online to look for health or other medical information.11 In addition, in the early 1990s, the

types of drugs that were marketed began to include lifestyle drugs, products that focused more

on improving the quality of life than on treating disease, such as Rogaine, a hair restoration

product targeted for men.12

With the growth of DTCPA came both skeptics and proponents of this new form of health

communication. One argument in support of DTCPA was that DTCPA encourages patients to

8
Ibid.
9
Ibid.
10
Donohue, Julie. "A History of Drug Advertising: The Evolving Roles of Consumers and
Consumer Protection." The Milbank Quarterly 84, no. 4 (December 2006): 659-99.
11
Ibid.
12
Ibid.

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contact a physician. The results of a 2004 FDA consumer survey showed that being exposed to

DTCPA prompted 27 percent of Americans to make an appointment with their doctor to talk

about a condition they had not previously discussed.13 A 2003 Harvard University/Massachusetts

General Hospital/Harris Interactive study also found that 25 percent of patients who were exposed

to DTCPA and who then visited their doctor received a new diagnoses with 43 percent of such

diagnoses considered to have a high-priority health condition.14 Another net benefit net benefit

to this increased exposure to clinicians, and another advantage of DTCPA, patients were more

likely to talk to their doctors about lifestyle changes and other preventative care measures.15

Supporters of DTCPA also claim that exposure to DTCPA removes the stigma associated with

certain diseases and thus encourages people to inquire about stigmatized diseases they would

previously not inquire about.16 In a poll that was conducted shortly after a 1997 DTCPA campaign

for a genital herpes treatment, 45 percent of people who called a toll-free number in response to

the advertisement made an appointment with their doctors within three months after seeing the

advertisement.17

Opponents of DTCPA, however, claim that DTCPA misinforms patients and

overemphasizes drug benefits.18 According to a FDA survey, 75 percent of physicians surveyed

believe that DTC ads cause patients to think that [a] drug is more effective than it truly is.19 The

same survey also found that physicians are often pressured to prescribe the drug mentioned in a

13
Ventola, C. Lee, MS. "Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic?"
Pharmacy and Therapeutics, October 2011, 669-84.
14
Ibid.
15
Ibid.
16
Ibid.
17
Ibid.
18
Ibid.
19
Sukel, Kayt. "How Are Direct-to-Consumer-Advertisements Changing Psychiatric Drug Use?" The DANA
Foundation. October 31, 2016.

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DTCPA when a patient brings up the advertisement. A 2007 study in the Journal of Health

Communication also found that DTCPA television commercials devote more time to the benefits

of the drug than to its risks, often misleading patients and leading to adverse health outcomes.20

Opponents also charge DTCPA with manufacturing disease, wherein the smallest of ailments are

viewed as a disease that needs medicating. For instance, Pharmacia & Upjohn, the maker of Detrol,

an over-active bladder medication, marketed its product to people annoyed by frequent urges to

use the bathroom.21 These types of DTCPA ultimately lead to an overly medicated society that

becomes dependent on OTC and prescription drugs alike.

Because it is so controversial, the arguments for and also against DTCPA are endless. What

is more interesting is the influence DTCPA has on drug use when it comes to managing stigmatized

illnesses. Take, for instance, mental illness. While mental illness was once stigmatized, it is now

at the forefront of DTCPA. Sara Becker, a researcher at Brown Universitys School of Public

Health claims psychiatric medications are among the most heavily advertised medications.22 She

adds, that people with certain psychiatric conditions might be more suggestible to the effects of

advertising. Becker and her colleague, Miriam Midoun, analyzed four studies that measured the

impact of DTCPA on treatment for mental illness. Some of their findings included evidence that

people actively requesting a medication they saw on TV or heard on the radio did seem to increase

prescribing.23 This finding is a double-edged sword, however, because while a patient who was

seriously depressed was more likely to get medication as a result of DTCPA, a patient who did not

20
Ventola, C. Lee, MS. "Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic?"
Pharmacy and Therapeutics, October 2011, 669-84.
21
Sukel, Kayt. "How Are Direct-to-Consumer-Advertisements Changing Psychiatric Drug Use?" The DANA
Foundation. October 31, 2016.
22
Ibid.
23
Ibid.

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meet the full criteria for depression and did not need to medicate was also more likely to get the

medication the DTCPA marketed.24

There are certain limitations in analyzing the relationship between DTCPA and drug use.

For instance, Becker notes that there is a scarcity of studies on the effects of DTCPA on drug use

for mental illness and she attributes this scarcity to the drop in public interest because the FDA

guidelines for DTCPA have not changed much in recent years.25 In addition, to date, the National

Institute of Mental Health (NIMH) has also not conducted studies in this area.26 Richard Kravitz,

a researcher at University of California Davis Center for Health Services Research in Primary

Care, notes that designing a study of this nature has large limitations. For instance, he says the

critical variables, such as number of patients who request medication and number of patients who

request DTCPA drugs constitute both a small sample size and are also difficult to measure. He

adds that this type of research study would not only be intensive but also expensive to conduct.27

While these limitations are legitimate and further study is needed to evaluate the extent of

the impact DTCPA has on drug use and other lifestyle modifications, what we do know is that the

rapid growth of DTCPA has impacted the public and has changed what health communication

means today. For better of for worse, as a result of DTCPA there are more drugs on the market;

more drugs that some may find unnecessary and ultimately lead to adverse side effects, but also,

drugs that the average American uses on a frequent basis, such as tylenol, motrin, and other

painkillers that have arguably led to an increased quality of life for many people. DTCPA has also,

again, for better or for worse, prompted patients to be more active participants in their health.

Sometimes this means pressuring physicians into prescribing them pills they do not need, but also

24
Ibid.
25
Ibid.
26
Ibid.
27
Ibid.

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it invariably means having a more open and informed dialogue with their physicians on the topic

of their health. The prevalence of the marketing of psychiatric medications has also, if not

destigmatized, but has normalized mental illness to the public. Looking forward, more community-

based public health organizations should acknowledge the impact DTCPA has had on the

American public and use some of the strategies that pharmaceutical companies has employed to

promote major lifestyle changes, such as decreasing sugar, salt, and trans fat intact. At the end of

the day health promotions is all about selling something, it is up to the organization at stake to

choose if that something is a product or a lifestyle change.

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 Works Cited

Center for Drug Evaluation and Research. "Prescription Drug Advertising - Drug Advertising: A
Glossary of Terms." U S Food and Drug Administration Home Page. https://
www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising/
ucm072025.htm#B.

Donohue, Julie. "A History of Drug Advertising: The Evolving Roles of Consumers and
Consumer Protection." The Milbank Quarterly 84, no. 4 (December 2006): 659-99. doi:
10.1111/j.1468-0009.2006.00464.x.

Sukel, Kayt. "How Are Direct-to-Consumer-Advertisements Changing Psychiatric Drug Use?"

The DANA Foundation. October 31, 2016. http://www.dana.org/News/How_Are_Direct-
to-Consumer-Advertisements_Changing_Psychiatric_Drug_Use/.

Ventola, C. Lee, MS. "Direct-to-Consumer Pharmaceutical Advertising Therapeutic or Toxic?"

Pharmacy and Therapeutics, October 2011, 669-84.

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