DTC Advertising and Preventative Healthcare

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Direct-to-Consumer Drug Advertising and Cultural Shifts Away from Preventative Public Health Initiatives in the United States Alexzandra E. Lizama Department of Government, College of William and Mary May 2015

This paper is being submitted on May 7th, 2015 for Government 491, Health Policy 

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TABLE OF CONTENTS

Background……………………………………………………………………….…3 Objective………………………………………………………………….……4 History of DTCA and Regulation………………………………………………………4 Controversy………………………………………………………………….….6 Relationship Between DTCA and Cultural Perceptions of Healthcare……………..…..11 Current Trends……………………………………..………………….…………13 Policy Options……………………………………………………………………14 I. Ban DTCA ………………………………….14 II. Develop Pre-Approval Requirements ………15 III. Government Marketing Campaign………….17 When and How Public Health Campaigns Are Effective………………………….…17 The Campaign…………………………………………………….……………19 Conclusion…………………………………………………………………………22 Appendices……………………………………………………………………23 Sources………………………………………………………………………..…24

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Background on Direct-to-Consumer Drug Advertising Direct-to-consumer drug advertisements (DTCA) are messages created by marketers of pharmaceutical companies to inform, persuade and entertain their target audience in hopes of influencing their attitudes, and ultimately, their behavior (Diel, Mueller & Terlutter, 2008). They can be found in print newspapers and magazines, in informational pamphlets, on TV and increasingly on various pages throughout the internet (Wang & Kesselheim, 2013). The United States is one of only two countries, the other being New Zealand, which allows pharmaceutical companies to advertise directly to consumers.

There are three types of DTCA’s: help-seeking, which provide information only about a medical condition but not a product, reminder, which include a product name but doesn’t make any claims, and product claim, which mention the product, its benefits/efficacy, and safety claims (FDA.gov). The United States Food and Drug Administration (FDA) exercises post-regulatory control over product claim advertisements only, which are the most common in the US, through the Office of Prescription Drug Promotion (OPDP) (FDA.gov). They review the accuracy of claims in order to ensure that DTCA are not misleading, present a ‘fair balance’ between benefits and risk of use, contain relevant facts and include a brief summary’ of every risk from the product’s approved labeling (Calfee, 2002; FDA.gov).

If an advertisement is determined to violate these requirements, the FDA will send a letter to the drug company asking them to remove the advertisement. In some circumstances, they will ask a drug company to fix a misimpression in a violative advertisement by publishing a corrective advertisement or a public statement. The FDA can also post enforcement letters on their web page, impose civil monetary fines, or sue the company. Civil monetary fines have proven relatively ineffective because they pale in comparison to the profits that these companies

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have at stake. The average fine is around $250,000, whereas profits for a blockbuster drug could start in the millions (Calfee, 2002). Because of this, a company could opt to pay the fine and reap huge profits without issue. If the FDA chooses to sue, which is rare, they have the right to seize supplies of the drug, ask for an injunction (court-enforced ban on specific activities), and even potentially bring criminal charges against the drug company (FDA.gov).

Objective The purpose of this study is to present a potential policy solution to an issue perpetuated by direct-to-consumer drug advertising (DTCA) in the United States. This issue is the negative impact that DTCA has had on American consumer trust in the efficacy of preventative healthcare. This study looks at trends in pharmaceutical culture, chronic diseases, and preventative health care attitudes in order to develop the framework for a public health education campaign.

History of DTCA and Regulation The 1938 Food, Drug and Cosmetic Act (FDCA) gave the FDA authority over the labeling of pharmaceuticals. However, the Federal Trade Commission remained in control of pharmaceutical advertising. This changed in 1962 under the Kefauver-Harris drug amendments.

They called for consumer protection from pharmaceutical promotion by requiring that all drugs be proved safe and effective before promoted. They did so by transferring authority for prescription drug promotional material from the FTC to the FDA (Wilkes et al, 2000). That year, the FDA created the Division of Drug Marketing, Advertising, and Communications (DDMAC; renamed The Office of Prescription Drug Promotion in 2011) to regulate these advertisements.

Throughout the period leading up to and after the establishment of DDMAC, most pharmaceutical advertisements were targeted exclusively to physicians and other medical

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professionals through medical journals (Cline et al, 2004). This is due in part to DDMAC regulations, which stated that all advertisements had to contain a ‘brief summary’ that stating all known risks of the drugs. This limited the ability of pharmaceutical companies to advertise commercially due to time and space constraints in print, and especially, radio and television advertising.

The first DTC drug advertisements ran in the early 1980’s. They were developed by Boots Pharmaceuticals (for the ibuprofen drug Rufen) and Merck (for the pneumonia vaccine Pneumovax) (Hutt, 2002; Ventola, 2011). These advertisements gave rise to an on-going debate between the industry, medical profession, and the FDA about the social, ethical and public health implications of advertising pharmaceuticals directly to consumers. However, the rise of these advertisements coincided with the rise of the consumer rights and advocacy movement, which was primarily driven by HIV activism. Because of this, the regulatory climate was in favor of consumer choice and empowerment through involvement in medical decision-making. Thus, the pharmaceutical industry saw a window of opportunity, took advantage of the trend, and then reinforced this cultural shift with an onslaught of direct-to-consumer advertisements (Donohue, 2006). The pharmaceutical industry argued that these advertisements would provide public knowledge and enhance consumer choice and autonomy, though critics doubted these claims (Donohue, 2006).

Due to concern about the implications of these advertisements, the FDA called a moratorium on DTCA from 1983-1985. In 1985, DDMAC stated that all advertisements had to include all information about major side effects and contraindications and spend equal amount of time on promotion and risk of a drugs (Wilkes et al, 2000). Following these new regulations, the industry relied primarily on print advertising because time constraints on radio and TV

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advertisements would prevent them from giving benefits and risk equal attention. In 1997, primarily due to pharmaceutical lobbying, the DDMAC published preliminary guidelines for DTCA and permitted promotional advertisements on TV and radio without balanced promotion and risk discussions as long sources for more information were provided (Ventola, 2011).

In 2006, the FDA updated these requirements, adding mandates for clear and concise prescribing information and prominent displays of the most important drug information. In 2010, DMACC created ‘The Bad Ad Program’ to in to inform healthcare providers of potentially misleading information and encourage them to report such advertisements. However, this didn’t help consumer’s very effectively because it is still post-regulatory in nature, meaning bad advertisements continue to enter the marketplace (FDA.gov, 2015).

Controversy The current literature has focused on three main ideas: how direct-to-consumer advertisements affect drug and health care costs, how they shape patient-provider relationships and how they are affecting clinical outcomes.

It is generally agreed upon that DTCA’s increase patient requests for specific advertised drugs, and that this significantly increases the likelihood that a physician will prescribe it (Wang & Kesselheim, 2013; Gilbody, Wilson & Walt, 2005;Weissman, Blumenthal, Newman, Zapert, Leitman & Feibelmann, 2004). It is well-documented that this phenomena increases the use of the advertised drugs, although scholars disagree about whether or not this negatively alters patient-provider relationships and clinical outcomes ( Wang & Kesselheim, 2013; Frosch, Krueger, Hornik, Cronholm & Bargh, 2007; Block, 2007; Gilbody, Wilson & Watt, 2005; Weissman, Blumenthal, Newman, Zapert, Leitman & Feibelmann, 2004; Jeffords, 2004; Wilkes, Bell & Kravitz, 2000).

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On one side of the debate, scholars worry that DTCA increases focus on high-cost patentprotected drugs over drugs that cure widespread public health issues. This is exemplified by pharmaceutical research, which tilts towards development of treatments for chronic diseases that affect more affluent markets because the profit margins are high, even if it is a ‘me-too’ drug or provides only subtle changes to an existing drug. This increasingly comes at the expense of more unmet clinical needs that represent smaller markets or are taken for only a short period of time (Leder et al, 2014). Additionally, scholars worry that they provide misleading and unbalanced information, that they promote ‘innovative’ drugs with questionable safety profiles, that they undermine patient confidence in provider opinions and that they ultimately lead to overconsumption of advertised pharmaceuticals at the cost of clinical outcomes and the public good (Wang & Kesselheim, 2013;Frosch, Krueger, Hornik, Cronholm & Bargh, 2007; Gilbody, Wilson & Walt, 2005; Jeffords, 2004; Wilkes, Bell & Kravitz, 2000).

According to research conducted by the FDA in 2004, 62% of primary care physicians and 52% of specialists believe that these ad’s cause patients to ask for unnecessary drugs, 60% of primary care physicians and 55% of specialists believe that many patients expect to get a prescription for every condition they have. Worse yet, consumers want prescriptions for advertised drugs over non-advertised drugs, even if they are way more expensive (Aikin et al, 2004). See Appendix A One example of this was Merck & Co.’s 2000-2001 Vioxx campaign. Vioxx, a drug meant to treat arthritis, carries serious cardiovascular risks and should not be prescribed to all arthritis sufferers. However their campaign featured general spots about ‘everyday victories’ for arthritis sufferers as though it was safe and effective for all arthritis sufferers. The campaign created ‘brand preference’ for Vioxx relative to the arthritis drug market, and many consumer’s

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requested it or doctor’s recommended it. However, over 47,000 serious cardiovascular complications in the US came as a result of the use of Vioxx between 1999-2007 (Prakash & Valentine, 2007).

Additionally, there are misconceptions about the regulation of these advertisements among consumers. In a 2000 study by MS Wilkes, half of respondents believed that ad’s were pre-approved by the government, 43% believed that only ‘completely safe’ drugs could be advertised directly to consumers, 22% believed that drugs with serious side effects had been banned, and 21% believed that only ‘extremely effective’ drugs could be advertised (Wilkes, 2000). This gives pharmaceutical companies unprecedented ability to persuade consumers without their best interests in mind.

On the other side of the debate, scholars and pharmaceutical companies argue that DTCA has not had negative effects on the public good, and may even be beneficial because they educate customers on common conditions and available treatment options, which empowers patients and leads to diagnoses that might have otherwise gone undetected by influencing consumer’s decision to visit a doctor (Block, 2007;Weissman, Blumenthal, Newman, Zapert, Leitman & Feibelmann, 2004).

Based on a comparison of these disagreements, it seems that DTCA can significantly affect clinical outcomes if it leads a patient to request a prescription from his provider, and this request effectively sways the provider to write a prescription. Weissman et al. concluded that there were no differences in health outcomes between patients who took advertised drugs over other prescription drugs, although this ignores the possibility that a condition could have been alternatively treated or prevented altogether (Frosch, Krueger, Hornik, Cronholm & Bargh, 2007; Weissman, Blumenthal, Newman, Zapert, Leitman & Feibelmann, 2004).

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Frosch et al argues that DTCA may have the effect of undermining preventive health behaviors in favor of using medications to treat many common conditions and diseases by misleading consumers about root causes disease and available treatment options (Frosch et al, 2007). This problem remains present regardless of whether or not these advertisements present balanced benefit-risk information because pharmaceutical manufacturer’s have no obligation to state alternative treatments, and actually have incentives to misrepresent the availability of alternatives, whether they be older and cheaper drugs or lifestyle changes. According to the FDA.org, DTCA do not need to include cost, generic alternatives, similar alternatives with fewer risks, if changes in behavior (such as diet and exercise) could help your condition, how many people have the condition, how it works, how quickly it works, or how many people who take the drug are helped by it (FDA.gov, 2015). From this list, it is clear that an advertisement could mislead consumers by simply leaving out certain information. These advertisements have thus contributed to the ‘medicalization’ of health in the United States.

Prevention Prevention is the avoidance of a disease. However, there are two different approaches to the concept: clinical prevention and public health prevention. Clinical prevention is the form of preventative healthcare that U.S. culture embraces. Clinical prevention is ‘reactive’ to disease and illness, includes screening and disease management, and uses expensive personnel, prescriptions, expensive technology, and one-on-one interventions. Gotzel (2009) stated that in the minds of lawmakers and citizens “prevention means getting mammograms, colonoscopies, Pap tests, prostate screens, and full body scans… [and] although these are called preventive services, they are actually screenings for disease in early stages of development” ( Hollar, 2012).

In contrast, public health prevention, which is the definition employed for the purposes of

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this study, is ‘proactive’ to disease and illness, and includes individual behaviors, such as diet, exercise and risk behaviors, environmental factors, such as pollution, safety, and opportunities for physical activity, and social determinants of health, such as education, housing and income.

Public health prevention uses health educators, social workers, and community health workers, educational programming, policy change and communities-at-a-time interventions to achieve improved outcomes (Hollar, 2012). Preventative public health care reduces cost, whereas clinical prevention actually increases costs.

Preventative public health care is superior to reactive clinical prevention and postdiagnosis treatment because it carries a higher success rate and is less costly. As a nation, we spend 86% of our healthcare dollars on the treatment of chronic illnesses. “These persistent conditions are the nation’s leading causes of death and disability, leave in their wake deaths that could have been prevented, lifelong disability, compromised quality of life, and burgeoning health care costs” (CDC: Chronic Disease and Prevention Promotion, 2015). The most costly diseases, in terms of lives lost and monetary expenses, include heart disease, cancer, chronic lower respiratory diseases, accidents, stroke, Alzheimer’s, and diabetes (CDC, 2015). Of these, more than 50% of heart disease cases are preventable with simple lifestyle changes, up to 95% of cancer cases are attributable to the environment and lifestyle, up to 80% of stroke cases are preventable, one third of Alzheimer’s disease cases are preventable, and 90% of type II diabetes cases are preventable (WHO, 2015; CDC, 2015). Additionally, the US has a higher disease prevalence, or the proportion of the population who has been diagnosed with a disease, for all of these major ailments when compared to Europe (Avendano et al, 2009). While this could be partially attributed to higher rates of detection via clinical prevention, it is more likely a reflection of their greater focus public health prevention.

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Relationship Between DTCA and Cultural Perceptions of Healthcare DTCA works better for drugs that treat widespread illnesses and that fulfill outcomes that consumer’s desire (Campbell, 2011). This means that there is an unequal representation of certain types of highly profitable (generally patent-protected) drugs in DTCA. For example, from 1989-1998, the top medical conditions that were mentioned in DTCA included: •

Allergies

•

Obstetrical/ Gynecological

•

Dermatological

•

Cardiovascular

•

HIV/AIDs

•

Tobacco Addiction From this list, obstetrical/gynecological, dermatological and tobacco addiction

pharmaceuticals are often optional treatments that consumers seek out at high rates.

Cardiovascular issues are some of the most widespread ailments in the US. Finally, HIV/AID’s was the ‘trending’ illness in the news during this time period. Thus, DTCA “promotes the medicalization of normal life…[because] the most heavily advertised drugs are for long-term use by large target audiences, often for mild conditions and ‘lifestyle’ problems that may not need drug therapy” (HAI-Europe, 2001). These pharmaceuticals feed into the ‘cultural fantasy’ that “pills can be used not only to treat and prevent disease but also raise energy, lose weight, lessen pain, lift mood, cope with stress, and enhance sexual and athletic performance (Leder et al, 2014).

As consumers become more accustomed to the notion of ‘instant fixes’ that take minimal effort, the perceived value of preventative healthcare measures decrease. Response efficacy, or an individual’s belief that a preventative health care action will decrease a health risk, is fashioned by two constructs, health motivation and specific health knowledge (Winters, 1998). If DTCA’s

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act as public health ‘education tools’, like proponents suggest, then even health-conscious consumers may view pharmaceuticals as the best prevention or solution method for disease and illness, regardless of whether or not this is the case.

They accomplish this through emotional marketing strategies like classical conditioning.

DTCA tends to lack quantitative evidence of a drug's benefits. Instead, they associate their drug with identity and relational rewards while ‘teaching’ the viewer what to expect from the treatment. According to a 2004 study by Cline & Young, 92% of DTCA depict exclusively healthy appearing people, 72% depict at least one person smiling, 43% depict people participating in physical activities, and 17% depict people in social activity (Cline et al 2004).

Usually, the positive activity that they are involved in relates to something that these consumers are currently unable, but yearn to do, because of their illness. This methodology reinforces perceptions that drugs are more effective than reality. These heightened expectations are what cause this ‘brand preference’, which feeds into over-prescription and negative cultural consequences (Donohue, 2006).

One example of DTCA feeding into this cultural phenomena is ‘erectile dysfunction’ as a health condition. For example, Viagra advertisements feature young athletes rather than old men.

The implication is [that] any episode of impotence, no matter how rare or mild is ‘erectile dysfunction’, there is a pill for it, and if this macho quarterback is not too embarrassed to ask for it, you don’t have to be either” (Angell, 2005, p. 87). These drugs, similar to many other consumer products, are advertised to consumer’s ‘ideal self’. These products help to complete a consumer’s self-concept by allowing them to reach their ideal state.

When defining a policy problem, Kraft and Furlong argue that “most policy problems have multiple causes, not a single cause, and therefore people disagree over which is the most

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important and which ought to be the source of public policy”(Kraft & Furlong, 2012, p. 175). In this case, DTCA is a major element influencing the ‘medicalization’ of health and culture of pharmaceutical dependence. This feeds into how society views health and healthcare, which has unique ethical, political and social implications. While DTCA is not the only cause of this cultural phenomena, it is the easiest route to solving the issue with policy because it provides a direct link to consumer education.

Current Trends While DTC advertising spend increased by nearly 330% between 1996 and 2005, it began to nosedive during the 2007-2008 recession (Mackey & Liang, 2015). According to Cegedim Strategic Data, DTCA spending decreased 22% from 2011 to 2012 (Pharma Marketing News, 2013). This has been attributed to the recession, a shrinking pipeline, meaning that fewer new drugs are being introduced into the market, the rise of generics, and the rise of biologics, or expensive research drugs that treat rare diseases (Mackey & Liang, 2015). This sudden decrease in popularity makes it an opportune time to take policy action, as it is no longer at its height of controversy and on the top of the pharmaceutical industry’s political agenda. See Appendix B The Internet has served as an increasingly important forum for drug advertising, especially for targeted drugs, with recent estimates of online DTCA spending topping $1 billion annually (Wang & Kesselheim, 2013). It is also very lucrative, with a 5:1 rate of return on investment, which is much higher than TV or magazine advertisements (Ventola, 2011). The Internet offers substantial patient empowerment through self-directed learning, but online DTCA has been criticized for not providing a fair balance due to platform constraints or seemingly neutral third parties presenting biased information without appropriate sponsorship disclosure. To combat these issues, the FDA released ‘Using Social Media Guidances’ in June 2014 for the

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industry (FDA.gov, 2014). The internet is an ideal platform for information, when compared to TV, radio or magazine because there are multiple sources to choose from at any given time.

Policy Options The major political players in this issue area include the pharmaceutical industry lobby, the FDA, and Congress. The American Medical Association (AMA) and the Courts also play less indirect roles. The two policy options meant to solve the negative consequences of DTCA that were brought up in the literature most often were either banning DTCA altogether or developing stricter oversight, especially through pre-approval requirements. I used Kraft and Furlong’s relevant evaluative criteria to look at all the policy options(Kraft & Furlong, 2012).

These include: •

effectiveness

•

efficiency (regulation)

•

political feasibility

•

social acceptability

•

administrative feasibility I. Ban DTCA Banning DTCA outright would be the most effective solution to mitigate its negative

consequences of DTCA relative to consumer information. However, it is politically infeasible and socially unacceptable. The pharmaceutical industry is extremely powerful and lobbies to Congress regularly. The issue of the iron triangle comes into play, because the industry lobbies to Congress, who then has a vested interest in supporting their views, and then the FDA cannot do anything without Congress’s approval and funding. Additionally, consumers generally favor the existence of DTCA because they feel that it increases their awareness about the market and involvement, so banning DTCA would not be socially acceptable.

The pharmaceutical industry could sue under corporation First Amendment rights to

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free speech if a ban on DTCA was attempted. During a series of cases from the 1970’s, the courts ruled that product advertisements were a form of ‘commercial speech’. A decade later, the Courts developed a set of criteria, named the Central Hudson Test, to determine whether a ban on commercial speech would be permissible. They do so by examining whether the advertising is misleading, whether a ban directly advances government interest, and whether this interest could be achieved through a less restrictive route (Ventola, 2011). The Courts have used this methodology to overrule prohibitions on alcohol, tobacco and medication advertising.

From the 1990’s up until the present, the courts have upheld pharmaceutical industry’s right to lawful free speech. They have found that the FDA has overstepped its bounds by preventing drug manufacturers from distributing articles that described off-label uses of pharmaceuticals or medical devices in independent journal articles directed at doctors, by restricting pharmacists from advertising their practice of compounding drugs, by banning pharmaceutical companies from disclosing and using records that revealed the prescribing practices of individual doctors for marketing or advertising purposes, and by prosecuting them for promoting off-label uses. Therefore, there is a clear precedent in favor of non-deceptive DTCA with minimal regulation under First Amendment free speech (Thomas, 2012; Caffee 2002).

II. Develop Stricter Regulation and Pre-Approval Requirements Developing stricter oversight and pre-approval requirements would be effective and socially acceptable, but it would be inefficient, administratively infeasible, and most likely politically infeasible as well. Pre-approval would successfully prevent biased advertisements from entering the marketplace and diffusing into the information environment. It would also be socially acceptable, because based on Wilkes 2000 study, most of the public already believes that

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these advertisements are pre-approved.

The OPDP already regulates and has laws in place governing what these advertisements can and cannot contain. Therefore, it would be easy to design a system using their current criteria to pre-approve advertisements. However, the FDA already lacks the staff to effectively review DTCA, so implementing pre-approval would create inefficiency by putting strain on the administration and causing delays in approvals (Ventola, 2011). The OPDP simply does not have the administrative capacity to pre-review every new advertisement entering the market without additional funding and staff. The FDA already does optional pre-review of advertisements, and has a hard time keeping up with regulation under the status quo.

Once again, the precedent set by the Courts relative to First Amendment rights combined with the likelihood that the drug industry would lobby heavily against this option, make it unlikely to be politically feasible. The pharmaceutical lobby would be outraged by the addition of long delays on top of the current drug approval process delays. In 2005, the AMA called for a temporary moratorium on DTCA, and among their promoted guidelines was a preapproval clause (PharmWatch, 2005). However, the proposal never received funding from Congress, which is likely due to the iron triangle and pharmaceutical lobbying.

Additionally, previous actions meant to coerce pharmaceutical companies into censoring their own advertisements have been discussed within congressional committees without ever making it onto the floor. These include: a prohibition on IRS deductions for DTCA’s, denial of tax deductions if an AD failed to present important risks or presented benefits and risks in an unbalanced manner, and a mandate on comparative research on safety and efficacy (Vogt, 2005). If these smaller policies cannot make any progress, it is unlikely that any other regulatory policy would.

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III. Government Marketing Campaign According to Wilkes et al, “ the medical community needs to develop a systematic, ongoing media literacy campaign to inform consumers of the promotional nature of DTCA” (Wilkes et al, 2000, p. 125). Building off this argument, a government-run advertising campaign could give consumers an alternative form of information regarding pharmaceuticals and the effectiveness of preventative methods relative to disease prevention. It would be effective and socially acceptable to the public, who desires accurate information. In order to be politically feasible, it needs to be neutral enough that it will not offend the pharmaceutical industry. And finally, it has the potential to be administratively feasible under the correct set of conditions.

When and How Public Health Campaigns Are Effective A public health mass media campaign is designed to change health behavior and improve health outcomes within given population. In order to be successful, these messages must enter the crowded media environment and manage to be heard over other competing sources.

According to the National Health Services (UK) Development Agency, public health campaigns are an effective policy method when awareness is the main goal, the media is ‘on-side’ with the campaign, public discussion is likely to facilitate the educational process, the behavioral goal is simple, a generous budget exists, and long-term followup is possible (Schlinger, 1976; NHS, 2004).

In this case, the goal is to provide awareness about pharmaceutical dependence, the true effectiveness of treatment via pills, and why preventative health measures are superior and cannot be replaced by pharmaceuticals. While behavioral change is the ultimate goal of the campaign, this will rely heavily on community-level programs relating to nutrition, exercise and

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other healthy habits that already exist. This is not inherently controversial, and the media tends to agree with this ideology.1 Additionally, the US Government is already promoting preventative activities (CDC Gateway to Health Communication & Social Marketing Practice, 2014). In this case, public discussion about the relationship between chronic disease and preventative activities is likely to facilitate the educational process of teaching the population of the extremely high costs, in terms of suffering and money, associated with treatment of these illnesses' relative to the simplicity of prevention.

One way a campaign can influence the public is by not only increasing the amount of information on a given topic, “but also [redefining] or [framing] the issue of the target audience, and [suggesting] a solution to resolve that problem” (Randolph & Viswanath, 420, 2004). In this case, the campaign will be framing the issue as our ‘pill-popping’ cultural fantasy, which contributes to high levels of preventable diseases due to ignorance about the root causes and preventative measures that can be taken against disease. The campaign will then propose simple and common health goals, such as nutrition and exercise, as alternative solutions for dealing with our cultural relationship to chronic illness, and how we prevent early death.

To do so, the campaign must maximize its exposure levels by successfully manipulating the information environment, which includes enlisting the media to advocate for the cause. Additionally, it must use creative marketing and messages. Gain-framed messages are more effective in promoting prevention, whereas loss-framed messages tend to more effective for promoting early detection/clinical prevention (Randolph & Viswanath, 2004). Therefore, this campaign should focus primarily on gain-framed messages. Fear appeals are another creative

1

Warner, Judith (2008). “Overselling Medication” The New York Times, Opinion Pages.

Maris, David (2012). “Who Is Popping All Those Pills?” Forbes.com: Pharma and Healthcare.

Carroll, Linda (2013). “Pill Nation: Are we too reliant on prescription meds?” Today.com; Health.

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strategy, and tend to be successful in increasing the perception of susceptibility, but must also clearly present the action they must take to avoid (Randoloph & Viswanath, 2004). Fear appeals may be used sparingly in this campaign to convince young adults that they are not immune to chronic diseases in old age. However, they should not be the basis of the creative strategy, as is common with anti-smoking campaigns, such as the 2012 TIPs Campaign, because they run the risk of the consumer shutting-down and ignoring the message. Overall, the campaign must promote a message that is salient to the target market, promotes a specific attitude they should adopt, provides a clear action they must take to follow through, and convince them that they are able to do so (Randoloph & Viswanath, 2004).

According to a 2014 article about “The Real Cost” Anti-Smoking Campaign, FDA researchers spent a year combing through the scientific literature, reaching out to experts, and most essentially, talking to their target audience, young people, through focus groups. The two concepts mentioned most often in these groups: the cosmetic health consequences and the loss of personal control (FDA.gov). This points to larger implications for public health campaigns.

Schlinger (1976 )noted that in “the absence of overt symptoms, many people feel safe or even invulnerable from disease…[and] health concerns are forgotten, suppressed, or repressed” (p.

303). Nearly all US teens already know that smoking can cause cancer later in life, but they do not identify with this distant possibility, and it is easy to dismiss in the moment. (Krisberg, 2014) Therefore, in order for your message to have salience with your target audience, it must be relevant to their short-term concerns and desires.

The Campaign While part of the The Office of Prescription Drug Promotion (OPDP)’s mission includes an ‘education program’ as part of their methodology for protecting public health through

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truthful prescription drug information, it does not seem as though the OPDP would have the administrative capacity to take on a campaign of this nature. It would be too directly tied to the pharmaceutical industry and would take away from its larger messages relating to early prevention and over-treatment of chronic illnesses. Additionally, their message would likely be watered down due to a certain level of regulatory capture that the industry holds over the FDA. Finally, the OPDP’s purpose is to act as a regulatory agency, and a campaign of this capacity falls outside of their current task framework (The Office of Prescription Drug Promotion: FDA.org, 2015).

The Center for Disease Control (CDC) is already promoting health messages about smoking, cancer and diabetes prevention, antibiotic resistance, nutrition, vaccines and many other related categories (CDC.org, 2014). Within the CDC, the Office of Noncommunicable Diseases, Injury, and Environmental Health, which includes the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), is the best suited for launching this campaign. Within the NCCDPHP, the Health Communication Science Office is responsible for relevant tasks such as: •

planning, developing conducting and evaluating cross-cutting communication projects and campaigns to inform media, health professionals, and the public about the prevention of chronic diseases and the promotion of healthy behaviors

•

providing media, communication, and marketing support to NCCDPHP’s divisions and programs

•

designing, developing, and coordinating the publication of print and audiovisual materials such as fact sheets, newsletters, speeches and presentations, exhibits, podcasts, and educational videos

•

managing the NCCDPHP’s Web site and coordinates scheduling and production of chronic-disease-related weekly features for main CDC Web site

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managing and coordinating scientific and public affairs clearance of NCCDPHP print and non-print materials, ensuring adherence to and consistency with CDC and HHS information and publication policies and guidelines In order to increase their credibility, the NCCDPHP can form a partnership with the

American Medical Association (AMA). Additionally, the NCCDPHP should hire an advertising agency to handle the creative work. The campaign must target medical facilities and be integrated with current state and local level initiatives to increase positive associations and reach (Wilkes et al, 2000). The campaign will rely heavily on social media and video content in order to reach younger consumers in higher number and at a lower cost relative to TV. The campaign must also contract out search engine optimization specialists to ensure that the government content comes up higher than pharmaceutical industry sponsored-content in organic searches.

The campaign needs to run for at least one calendar year in order to be successful due to the breadth and depth of the information it will cover.2 The campaign will contain a series of different advertisements related to different body parts (ex. Take it to Heart), specific diseases (ex. Cancer Treat It) and the preventative care vs. the treatment methods available alongside benefits and risks of each. However, no specific brand names will be mentioned, in order to keep pharmaceutical companies from feeling directly targeted or threatened. The campaigns focus will be on why preventative measures are more protective and superior than clinical prevention or treatment, the costs associated with each method, and education about the benefits of generics and heavily tested older pharmaceuticals over ‘trendy’ newer drugs. The campaign will also focus on the concept of the body healing itself, with pharmaceuticals providing support after something has already gone awry (Leder et

2

Estimation based off the 2012 success of TIPs campaign, which dealt with quitting smoking as preventative action, and ran for 3 months.

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al, 2014). It will attempt to crush the cultural notion that pills are a ‘cure’ for any and every disease. Each individual advertisement will need to provide a specific action that the consumer can take and how they should go about it. The advertisements must also focus on what consumers care about in the short-term (such as smoking and wrinkles) in order to relate more closely to a consumers self-image. Finally, the advertisements should focus more heavily on the positive benefits gained from these lifestyle changes over the absence of suffering.

Success of the campaign will be monitored based on views, engagement and impressions. The CDC can also conduct self-reported studies on the preventative activities mentioned in the advertisements and on trends in pharmaceutical usage. Finally, the CDC can conduct a study asking physicians about their perceptions of trends in the issue area following the campaign.

Conclusion DTCA is here to stay in the United States due to corporate protections under the First Amendment. The political environment surrounding the regulatory framework also makes it nearly impossible to significantly change. Under the current conditions, DTCA provides both costs and benefits, although the costs slightly outweigh the benefits due to their ability to be truthful and deceptive concurrently. However, if a successful public health mass media campaign was launched to educate consumers on the relationships between DTCA, chronic diseases preventative healthcare, the cost-benefit analysis of DTCA could be balanced without changing the system itself.

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Appendix A: FDA Research on Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs (Aikins et al, 2004)

Appendix B: DTC Ad Spend from 1996-2012 (Pharma Marketing News, 2013)

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