Improving HPV Vaccine Intervention through Social Science Theory- Alexandra Hulme

Public Health Problem

In June of 2006, the FDA approved the vaccination Gardasil for females between the ages of 9-26 to protect against types 6,11,16 and 18 of the Human Papillomavirus (HPV) that indicate an association to genital warts and cervical, vulvar and vaginal cancers, respectively (1). This vaccine was a game changer in the medical field as it was the first of its kind to show 100% efficacy in preventing cancers, in this case those caused by those strains of HPV (2). While it usually takes 10-15 years for cervical cancer to develop from first HPV infection, the best time to vaccinate is before a female’s first sexual experience, due to the high prevalence of HPV: 39.6% in women ages 14-19 and 49.3% in women ages 20-24 (3). The lag time between infection and development of cervical cancer and the high prevalence rates, and the nature by which HPV is contracted - typically sexual interaction - makes it a very unique vaccine to promote and support.

Merck, the developer of Gardasil, employed several campaigns to promote Gardasil, including an unbranded educational, pre-release campaign, the “One-Less” campaign and the “Tell Someone” campaign (A. Mueller, personal correspondence, 7 March 2011). All of these campaigns had to promote the vaccine to a wide aged cohort, because the vaccine was suggested for women ages 9-26. This makes its universal acceptance difficult because the way in which these target audiences need to be addressed, especially in relation to such a polemic topic. By 2008, 37% of the 9-26 female population had received the vaccine (3), but there was still reluctance in widespread acceptance of the vaccine. This paper will provide three critiques of the current HPV prevention campaign and then provide three suggestions for improved interventions to increase both awareness and acceptance of the vaccine.

Critique # 1

Failure of the Health Belief Model

The GARDASIL campaign was heavily grounded on two un-branded campaigns that served to educate the public about HPV, its connection to cervical cancer and new technologies that are being developed to prevent the disease. These campaigns were successful in increasing awareness and knowledge to both mothers and young adults, showing an increase from 5% awareness to over 50% awareness of the link between HPV and cervical cancer (4). The objectives here fall in line with the Health Belief Model approach to public health campaigns, that focus on increasing knowledge to affect an individual’s perceived susceptibility to contracting a disease and the perceived severity of the outcome (5). As an individual starts to perceive an increased risk of the negative outcome, they will then rationally do what is needed to protect themselves (6). In the case of GARDASIL vaccination, the idea was to increase perceived susceptibility to HPV and cervical cancer and then the women, with their newfound education, would take the appropriate steps towards vaccination. This approach however is flawed; an individual’s health decision is not rational, and the balance between costs and benefits do not always dictate intention to act and behavior. The health belief model has little strength in accounting for the variety of behaviors that are related to attitudes and beliefs, because there are a variety of forces that can influence and individual’s behavior (7). While education is an important component in any public health campaign, especially when there was little previous knowledge about the connection between HPV and cervical cancer and the susceptibility to such diseases, a successful campaign cannot depend on education alone.

Merck highlights young adult females as one of the primary target groups for the campaign and vaccination (A. Mueller, personal correspondence, 7 March 2011). They were the center for many focus groups and education campaigns to improve their education on the subject of HPV and cervical cancer in an attempt to get them to seek out the vaccine. A large flaw in this approach is the assumption that just because people have knowledge they will act in a responsible manner to mitigate the threat (perceived severity and susceptibility to HPV and cervical cancer). This increased knowledge was shown to be successful, but did little to influence their perceived susceptibility, even though they are at a high risk due to their sexual behavior (8). As a behavioral economist, Dan Ariely and others have demonstrated, humans are not the rational, predictable creatures that the Health Belief Model would like to believe they are. People are influenced by stereotypes, labels and expectations, which changes their behavior and causes them to act differently based on cultural expectations (9). In most situations when something is considered dangerous, such as risky sexual behavior, there is a tendency to want to continue with that behavior, because the consequences of one’s actions are not usually considered in the moment, nor is one’s intention to act an automatic stimulus for expected behavior. Education and awareness of a disease does not automatically result in change behavior and increased used of the HPV vaccination.

Specifically in this campaign, more emphasis was placed on GARDASIL as a preventative vaccine for cervical cancer, instead of its clinical prescription as a vaccine for HPV. In an attempt to be less controversial for the mother’s of young girls (a target audience), the anti-cancer campaign was more effective than an HPV driven campaign and increased the mother’s perceived threat and susceptibility for their daughters (10). This push to educate mothers, focused on mother’s telling or taking their daughters to get vaccinated and not on creating an incentive or reason YAFs to get vaccinated. Eliminating the connection between HPV and cervical cancer discouraged YAFs from getting the vaccine, because even though they had information from the campaign, it was not appropriate for their needs or demographics. (4,10, 8). The campaign failed in its education campaign because it limited what information was transferred to target audiences, not that it lacked the knowledge to educate their audiences. This element played into the ineffectiveness of the education campaign because while there was increased knowledge, individuals behave irrationally and could not connect their actions and perceived risks indicated to them to change their behavior.

Critique # 2

Limitations of Social Norms and Sex

The connection between HPV and cervical cancer and the need to spread the message to such a large target audience (girls 9-26 years old, FDA recommendation), posed a daunting question for promoters. Researcher Suellen Hopfer comments that this vaccine posed a “new challenge in health message design because promotion of the vaccine raises questions inextricably linked the sexual health and cancer – both topics that are culturally sensitive and taboo” (11). In following the social norms theory we know that people’s behavior is largely driven by social norms, but it is hard to know what the norms are. The current social norms that dictate our society downplay the discussion of sex and sexually transmitted diseases, though HIV/AIDS has probably improved the situation. Because of this sexual taboo, the discussion of HPV as a sexually transmitted infection was heavily downplayed in the campaign (10). The campaign focused on parents and getting mothers to take their younger daughters to get vaccinated, but for many, thinking about the future sexual activity of their daughters is not something which they regularly consider (A. Mueller, personal correspondence, 7 March 2011). Thus, the campaign focused on promoting GARDASIL as a cervical cancer vaccine, so as not to be so divisive with parents and thoughts of their young daughters being sexually active, if not now then in the future (12).

In devising a campaign that emphasized the prevention of cervical cancer, the marketers were able to heavily bypass that conversation and successfully appeal to the mothers of the girls on the younger end of the target audience. This approach maximized the threat of cervical cancer and HPV to adolescents, while minimizing those who were most at risk (10). Merck recognized the limitations that our cultural sensitivity would do to the appeal of an HPV vaccine if it were marketed as such (4). While this aspect allowed it to draw in a large population of younger girls, who were brought to get vaccinated by their mothers, the campaign’s focus on cervical cancer ignored and isolated young adult females (YAFs), limiting the effectiveness of the campaign on that age demographic (13).

Because the campaign focused on cervical cancer, the social norm regarding HPV vaccination in YAFs was very seldom looked at. Following the social norms theory, social norms affect human behavior, but there was little arena for the discussion of what the social norm is, within the context of HPV and who was getting or not getting vaccinated. Hopfer discovered that is hard to reach college age women because it is hard to know the types of messages they receive in regards to such stigmatizing topics like HPV (11). The failure of the campaign directed at YAFs was so unsuccessful that Merck ended up pulling the funding for that entire component of the campaign (A. Mueller, personal correspondence, 7 March 2011). It was clear in focus groups that YAFs knew about their risks and did not react, they did not relate to cervical cancer message tilt of the marketing campaign, which was guided by the social norms of our times.

Critique # 3

Lack of Self-Efficacy and the failure of the Theory of Planned Behavior in HPV Vaccine Interventions

The existing campaign encouraging HPV vaccination provides lots of information to potential vaccine candidates, but does little to account for their actual intention to change their behavior in regards to safer sex and getting the HPV vaccination to prevent an HPV infection or cervical cancer. The Theory of Planned Behavior, developed by Ajzen and Fishbein, is the weighing two things against each other: outcome expectancies of the behavior and perceived norms, which lead to and dictate intention to act, which will lead to behavior (6). Included is also the component of self-efficacy of perceived behavioral control: a person’s belief that they are capable of doing a behavior, which is another influential element in the process to actually performing a certain behavior. An appeal to one’s self-efficacy in actually changing their behavior is thus necessary for any successful campaign.

However, the current HPV intervention is unsuccessful at appealing to this need and desire. By simply providing information to the targeted demographic about the dangers of HPV or cervical cancer, little connection is being made to the individual and their ability to change their behavior. Ajzen’s theory proposes that perceived behavioral control can influence behavior directly and that those with higher perceived control are more likely to form intentions to perform a particular action than those who perceive they have little or no control (14). Media campaigns, like GARDASIL, predominantly addressed the mother of adolescents, to get the vaccine for their daughter, but ignored the needs of the adolescents or young adult females themselves in seeking their own change in behavior (13). In following the theory of Planned Behavior, this does not allow the individual the opportunity to weigh the outcome expectancies or perceived norms themselves which will lead to intention and behavior change.

Researcher M.C. Yzer and colleagues analyzed several safer sex campaigns and their effectiveness on self-efficacy, along with other variables (15). They found that planned behavior in relation to safer sex (which also relates to HPV transmission) actually changed people’s behavior. However, their results show that these changes dropped, when the mass media campaigns dropped, indicating the need for campaigns to maintain high levels of determinants of safer sex, because they are effective for stabilizing and enhancing determinants of safer sex behavior (15). This demonstrates the ability of and need for campaigns that do not just inform, but that show individual’s their ability to change what they do and how they behave for the better, in a demographically specific environment.

Because the HPV intervention does not emphasize and individual’s power or control, but depends on that of her mother or peer, she is unable to take the necessary steps towards behavior change, driven by her own self-efficacy. As shown in another study on condom use, chronic perceptions of HIV risk are minimally linked to preventative behavior (14). This shows, that even with all the information promoting the dangers of not getting the vaccine and the potential consequences, those who are at risk or believe they are risk, are not likely to change their behavior because of that perception.

It is not just the knowledge that is necessary, but also the tools to enact that knowledge which will lead to greater self-efficacy and behavior change. The GARDASIL campaign fails to address this need of self-efficacy, though that is usually an important factor in mediating the relationship between knowledge and behavior (16). The ‘One Less’ campaign focused on an individual joining a movement and deciding for themselves to be one less person who gets cervical cancer, it did not take the next step in showing their target audience how to actually take that step, and make that change for themselves. It empowered through knowledge, but not through action and behavior. Had the campaign focused on improving confidence in the ability to enact healthy behaviors, then the desired change would follow, because the campaign would focus on efficacy expectations not just information dissemination, as was shown to work in a study on exercise behavior. This study also showed that those with greater levels of self-efficacy engage more often in and tend to stick to a regular schedule of physical activity, indicating the importance of regular reminders and campaigns to maintain behavior change, similar to the results of the safe sex campaign study (15,16).

In failing to appeal to what Ajzen’s theory of planned behavior proposes: perceived behavioral control can influence behavior directly (14), the current HPV intervention is inadequate. In 2008, only 25% of US females 13-17 had received the started the vaccination, though HPV prevalence in the 14-19 year age group is 39.6% (2). The study showed that while 90% of adolescents and young woman understand that the best time to get vaccinated is before their first sexual experience, and that they show high levels of acceptance of the vaccine, actual vaccination rates are low (2). The information from the campaign is reaching its audience, but is not influencing their behavior, and that is the most key factor because, it is only behavior change that will improve the health of targeted demographic.

INTERVENTION #1

Redirecting the Campaign – Beyond Education

The Health Belief Model is limited in its effectiveness and as a result GARDSASIL’s campaign is flawed. Education campaigns need to value how the message is developed and administered to the target audience. The campaign should focus on psychology of persuasion and entice people to get the vaccine, not just through education, but by promising them something more exiting in return for an intentional behavioral change (having protected sex and getting vaccinated). The promise of the campaign needs to come from a messenger that the YAF population likes, focusing on similarity and familiarity to develop a meaningful association between the audience and the message. The manner in which the request is structured can and should be tied to a specific, stored trigger and thus direct the individual to the action that is desired (17). Understanding that education will not change or influence an individual’s behavior because she is predictable yet irrational, the campaign should play into these characteristics to increase success and the ownership of their decision, their body and the value of preventing HPV and cervical cancer. Increasing the value of the vaccine for YAFs is very important because, as it stands now, there is a limited connection in the campaign to something to which they can relate: STIs and unprotected sex. When individuals engage in unhealthy behaviors they own and value their actions, so to change their behavior they need to exchange it for something of higher value. In the case of HPV vaccine, they need to appeal to a value that is higher then health. The campaign could appeal to a cleaner, less risky sex life or focus on the portrayal of a more glamorous life after getting the vaccine and having protected sex, instead of just increasing the education component and pushing the prevention of cervical cancer.

INTERVENTION # 2

Challenging Social Norms

Without information guiding the social norms of the young adult female cohort, intervention strategies will continue to be ineffective. Research has shown that social influences were key correlates to vaccine decisions (18, 11 ,19), but research regarding what the social norm is and who can influence those is the first step in creating a more successful intervention campaign. A new direction is needed, one that normalizes vaccination within the YAF population and uses peer-led campaigns to encourage future vaccination. This new approach takes advantage of the research findings of (19) who found that the social norm of the HPV vaccination (peers also going to get the vaccine) had the strongest influence on being vaccinated. Additionally, when widespread acceptance of the vaccine is emphasized it will promote further acceptance by others (13).

On college campuses or in workplaces that are predominantly staffed with young adult females, interventions that focus on promoting a unified front of acceptance for the vaccine – a normalized behavior – will continue to reach a wider audience. Showing that more of one’s peers are vaccinated or in the process of getting vaccinated, will push those who are undecided or unsure of what others may think, to do the same, increasing the acceptance for all. Shifting the media campaign that showed mothers can do this and adolescent girls getting vaccinated, to more young adult females (an older age demographic than adolescents) who got vaccinated or are talking with their friends that got vaccinated in a collegiate environment. Another approach would be to increase the distribution of information on the number of women within the targeted age demographic who already got vaccinated. Since it is something that is not easily discussed, showing how commonly accepted vaccination is, will decrease the idea of the HPV vaccine as a taboo subject and will normalize both its discussion and the acceptance of the vaccine. By changing the social norms of our society, behavior change will also be initiated. This part of the program is less education based and more grounded in awareness and discussions of typically culturally taboo subjects of sexually transmitted infections.

INTERVENTION # 3

Improving Self Efficacy

It has previously been shown that improving one’s self-efficacy will lead to greater health outcomes, something the current HPV intervention does not do. A new way of approaching self-efficacy is to address the barriers that people perceive when they try to get about getting the vaccine or take the first step to change their behavior (14). This idea includes addressing factors such as insurance coverage, history of STI, doctor/family recommendation (2). For example, by limiting the price of the vaccine or making insurance companies cover the vaccine, which is roughly $360 for a full series of three shots (1), women will feel more in control and able to actually change their behavior.

Focusing on the previous similar achievements of an individual can also make improvements to the intervention, because prior performance accomplishments are typically a dependable source of efficacy expectations if they are based on one’s own personal experience (16). The intervention could draw attention to the success of other vaccination campaigns and the frequency with which people seek the flu vaccine or the Hepatitis B vaccine. By demonstrating to the candidates that they have already taken a similar step towards a similar goal in the past, will be motivation and proof, that they are capable of similar behaviors, even if they address another area of health.

Furthermore, reviewing pre-action behaviors can also improve self-efficacy. In a study that looked at condom use and safe sex practices, those who had condoms available and had talked to their partner about using a condom were more likely to use a condom as the “event was under personal control of the client” (14). In relation to HPV vaccination, this could include discussing with peers and family members beforehand, but also looking at choices that those in targeted age demographics have successfully completed beforehand. Since, uptake with YAFs is lower than expected, targeted campaigns that show their self-efficacy and success in moving away from their families, starting a job or going to college, making independent choices about eating, smoking, drinking, sexual, physical behavior, will prove to them they have done something similar before and are capable of doing it again (16).

CONCLUSION

As a result of the variety of ways in which health campaigns can be designed and disseminated, there are different ways to then also critique and improve. The three critiques above all address different aspects of the current HPV vaccination campaigns from the perspective of the health belief model, social norms theory and theory of planned action, respectively. While they pin point and target to whom the information is given, how the information is given and what the information and campaign addresses, the final goal is to increase acceptance of the HPV vaccine, specifically for the young adult female population. Different individuals with different goals and support devise campaigns such as these and therefore, there is no one right answer. However, using social science theories that are grounded in successful evidence-based approaches can only lead to the future success of public HPV vaccination campaigns.

REFERENCES

1)U.S. Food and Drug Administration. Gardasil. (2011). www.fda.gov

2) Gamble, Heather, Klosky, James L., Parra, Gilbert R., Randolph, Mary E. (2010). Factors Influencing Familial Decision-Making Regarding Human Papillomavirus vaccination. Journal of Pediatric Medicine, 35(7) 704-715.

3) Centers for Disease Control and Prevention. Vaccines and preventable disease: HPV vaccination. (2011). www.cdc.gov

4) Herskovitz, B. (2007). Brand of the year. www.pharmaexec.com

5) Cameron, K. (2007). A practitioner's guide to persuasion: An overview of 15 selected persuasion theories, models and frameworks. Patient Education and Counseling, 74, 309-317.

6) Freudenberg N, G. S. (2008). The impact of corporate practices on health: Implications for health policy. Journal of Public Health Policy, 29, 86-104.

7) Salazar, M. (1991). Comparison of four behavioral theories. AAOHN Journal, 39, 128-135.

8) Lopez, R., & McMahan, S. (2007). College women's perception and knowledge of human papillomavirus (HPV) and cervical cancer. Californian Journal of Health Promotion, 5(3), 12.

9) Ariely, Dan. (2008). Predictably Irrational. New York: Harper Collins.

10) Rothman, S. M., & Rothman, D. (2009). Marketing HPV vaccine: Implications for adolescent health and medical professionalism. Journal of American Medical Association, 302(7)

11) Hopfer, S., & Clippard, J. R. (2011). Women's HPV vaccine decision narratives. Qualitative Health Research, (21), 262. doi:10.1177/1049732310383868

12) Dederer, C. (2007, February 18, 2007). Pitching protection, to both mothers and daughters. The New York Times.

13) Marlow, L. A. V., Waller, J., & Wardle, J. (2007). Parental attitudes to pre-pubertal HPV vaccination. Cancer Research UK Health Behaviour Unit, Department of Epidemiology and Public Health, UCL.

14) Albarracin, D., Johnson, B. T., Fishbein, M., & Muellerleile, P. A. (2001). Theories of reasoned action and planned behavior as models of condom use: A meta-analysis. Psychological Bulletin, 127(1), 142.

15) Yzer, M.C., Siero, F.C., Buunk, B.P. (2000). Can public campaigns effectively change psychological determinants of sager sex? An evaluation of three Dutch campaign. Health Education Research, 15 (3), 339-352.

16) Rimal, R. N. (2001). Longitudinal influences of knowledge and self efficacy. Journal of Health Psychology, 6(31) vaccination. (2011). www.cdc.gov

17) Cialdini, R. (2007). Introduction and chapter 1: Weapons of influence. Influence: The psychology of persuasion (pp. xi-xiv, 1-16). New York: Harper Collins.

18) Allen, J. D., Othus, M. K. D., & Shelton, Rachel C., et al. (2010). Parental decision making about the HPV vaccine. Cancer Epidemiology, Biomarkers and Prevention, (19), 2187.

FDA Proposed Graphic Images On Cigarette Packs: An Effective Public Health Campaign? – Joseph Sabato

Introduction

Beginning in 2001, Canada was the first of 28 nations to begin to display large graphic warnings on cigarette packs (1). These warnings contain graphic images of the potential health effects that can be caused by smoking. These images are often accompanied with written information that informs the purchaser of the cigarettes of one or more of the health risks from smoking and identifies where they can go to receive help quitting smoking. These campaigns have shown mixed results at reducing the prevalence of smoking (2).

In 2009, the Food and Drug Administration (FDA) embarked on a similar campaign to require tobacco companies to place graphic images along with warnings on the front and rear of cigarette packs (3). The last time the U.S. mandated a labeling change in cigarette packaging was in 1984; which resulted putting one of four rotational Surgeon General Health Warning statements on the side of cigarette packs (3). On November 12 2010, the FDA unveiled both the images and accompanying warnings to much fanfare with Kathleen Sebelius, Health and Human Service secretary, declaring that, “Today marks an important milestone in protecting our children and the health of the American public” (4). The graphic images will occupy the top 50% on the front and rear of cigarette packs; the FDA is also requiring that these images are placed on cigarette advertisements as well (3). The FDA initially plans to utilize nine of the graphic images in conjunction with warning statements and will rotate these images in and out of use to prevent the images from becoming stale (3). One of the chief goals of this campaign is to get cigarette users to notice the warnings and graphic pictures (3).

While this effort is indeed a significant change from the current U.S. labeling practices for cigarette packs; there are some concerns that this intervention falls short in its effectiveness due to utilizing antiquated behavioral science theories. One major weakness of this campaign is the underlying theory the campaign is based on, the health belief model – the FDA focuses on aspects of this theory that have been shown to not be effective in changing behavior such as relying on communicating to smokers the severity of risk as opposed to the health benefits of not smoking. A second major weakness in this campaign is that it the campaign does not provide any information on how or where a smoker can turn to receive support for quitting smoking. Lastly, another major weakness of this campaign is that it fails to account for how individuals exposed to the graphic warnings may react. These three weaknesses are described in more detail in the discussion below. The flaws in the FDA campaign are a result of the failure to consider the weaknesses of the social behavioral models being used. At the end of this analysis appears a discussion with suggestions for an improved campaign that considers both the benefits and weaknesses of the social behavioral models being used by the FDA along with consideration of the experience with the graphic cigarette warning program internationally.

UTILIZATION OF THE HEALTH BELIEF MODEL

The health belief model was established in the 1950’s by the U.S. Public Health Service and refined in 1966 by Irwin Rosenstock and was initially used to inform researchers and health practitioners under what conditions people take action to prevent, detect, and diagnose disease (5). A key feature of the health belief is that model describes the process by which an individual changes their behavior based on their perceived susceptibility of a disease, the threat of that disease and lastly the perceived benefits of changing their behavior by taking preventative action (6). The health belief model consists of three stages where an individual first learns of their perceived susceptibility to a disease, determines how serious that disease is and finally what benefits they would get from changing their behavior (5).

In addition to requiring cigarette companies to post graphic images on cigarette packs and advertisements the FDA is also requiring nine warning statements which will appear in conjunction with one of the graphic images. These statements are: “WARNING: Cigarettes are addictive.”, “WARNING: Tobacco smoke can harm your children”, “WARNING: Cigarettes cause fatal lung disease”, “WARNING: Cigarettes cause cancer” “WARNING: Cigarettes cause strokes and heart disease”, “WARNING: Smoking during pregnancy can harm your baby”, “WARNING: Smoking can kill you”, “WARNING: Tobacco smoke causes fatal lung disease in nonsmokers”, and “WARNING: Quitting smoking now greatly reduces serious risks to your health” (3). Each of these statements in conjunction with the graphic images is aimed at convincing a smoker to quit smoking by informing the smoker of the various health risks that “can” result from smoking. In other words, the FDA uses the health belief model to convince smokers that smoking is hazardous to their health and utilizes the graphic images to describe just how severe the health consequences may be.

Numerous studies have demonstrated that the health belief model is not effective at convincing individuals to change their behaviors because the model does not include someone’s self-efficacy as an explicit variable in the model (7-8). Self-efficacy is an individual’s belief in their own ability to quit smoking (9). This is particularly relevant for quitting smoking as a person is addicted to smoking and many of an individual’s normal daily routines involve smoking a cigarette. A smoker is accustomed to waking up and smoking a morning cigarette; having a cigarette when driving; or taking smoke breaks with other individuals. When that person begins to think about quitting they consider how much smoking has become a part of their life, and thus may have a limited belief in their own ability to successfully quit (7). Self-efficacy is a dynamic process that changes as a person relapses back into smoking with an individual’s own confidence to quit smoking wavering after a lapse back into smoking (10). By framing these images with the health warnings the FDA does not acknowledge the individual barriers an individual may face when deciding and undertaking quitting smoking and how these barriers impact their perceived ability to quit smoking.

Another limitation of the health belief model is that it relies on educating individuals and asking them to change their behavior rather than changing the environment under which they smoke. Recent research has shown that changing the environment in which one smokes is a far more effective health intervention than asking smokers to change their behavior. One way to accomplish this is through raising taxes on cigarettes. For example, in Australia the effectiveness of both media-based campaigns and smoking tax increases at reducing cigarette usage were examined. The taxes on cigarettes were found to have a more immediate, effective and lasting impact on smoking rates than media-based campaigns (11). The authors indicated that behavior change associated with the media-based campaigns was tied closely with recent media exposure (11). In addition, taxes on cigarettes have been shown to be extremely effective at reducing cigarette usage among youths and the poor (12). Another way of changing the environment is to enact smoke-free environments, where smoking in public places is banned. Smoke-free environments in Scotland were cited by 44% of smokers as a reason they quit in 2006 (13). In addition to driving individuals to quit, smoke-free environments have the added effect at decreasing exposure to second-hand tobacco smoke (12). The indication here is that smoke-free legislation combined with tax increases is effective at deterring both youths and the poor smoking.

Lastly, the portion of the health belief model that is being utilized by the FDA (severity of risk) has been shown in research to be the one portion of the health belief model that has been least effective at changing people’s behavior (14). Studies have found that individuals are much more likely to change their behavior when a health message is communicated focusing on the benefits of a proposed action or focusing on their personal susceptibility to health risks resulting from the action (14). Additional research found that consideration of the barriers to quitting that an individual encounters has also been shown in research to result in more effective public health campaigns (14). One researcher notes that when health campaigns are based on fear, individuals can be turned off by the message and rebel against it (15). This suggests that a far more influential technique by the FDA should be to focus on the perceived benefits to quitting smoking.

LACK OF SUPPORT FOR QUITTING SMOKING

One of the goals of the FDA campaign is to, “support intentions among current smokers who want to quit” (3). However, one serious limitation of the FDA campaign is that it does not provide any information to smokers on where they could seek assistance in quitting smoking, nor does the FDA provide information to smokers on methods and/or techniques which are effective at helping someone quit smoking. Providing information on free quit line services results in increased utilization of quit lines, increases in the number of smokers who successfully quit smoking and increased effectiveness of the graphic cigarette ads, lastly exposure to the quit line on cigarette packs has shown the ability to reach a more diverse audience.

Experience in Australia, The Netherlands, and New Zealand with including the quit line on cigarette pack warning campaigns has shown tremendous success. Australia saw the number of calls to the quit line double immediately preceding the initial roll-out of the campaign, although the number of calls tapered off, the number of calls to the quit line continued to remain higher than previously seen (16). The experience in the Netherlands is similar with calls to the quit line approximately 3.5 times higher after including the quit line number along with the new warnings on cigarette packs (17). Investigators in New Zealand found that after including the quit line number on new graphic cigarette warnings that calls to the quit line were impacted more by the cigarette packs than by television advertisements (18). If the results in The Netherlands, Australia and New Zealand are any indication, it would seem that ff the goal of the FDA campaign is to truly support current smokers who want to quit, one extremely simple solution would be to include the quit line in conjunction with the warnings on cigarette packs.

Telephone and web based counseling services for quitting smoking have become a mainstay of many anti-smoking efforts; with quit lines having a positive effect in individuals successfully quitting smoking; and in reducing the number of relapses an individual suffers. In 2003 the United States established a toll-free portal to state quit lines making it easier for individuals to receive assistance in their anti-smoking efforts (19). The effectiveness of quit lines has been shown in randomized control trials, with many of these studies demonstrating that telephone counseling for tobacco cessation can significantly increase the long-term quitting success of adult smokers, with some studies showing effectiveness of up to 30%(19-22). Thus, inclusion of quit lines into any anti-smoking campaign would seem to be a prudent decision as research indicates that quit lines offer a cost-effective intervention with the capability of serving diverse populations in helping them quit smoking (21, 23).

Socioeconomic status (SES) is strongly associated with smoking prevalence and lower SES is also associated with less knowledge of the potential health risks from smoking (24). Research has also found that person’s with lower SES have lower intentions to quit, and lower self-efficacy to quit; this indicates that it will likely take intensive support in order to help individuals with low SES to quit (24). In The Netherlands after implementation of the graphic cigarette campaign, they discovered that the campaign was effective at reaching individuals from lower SES (17). By not including quit line information in conjunction with the graphic warning campaign, the FDA has limited the reach of the campaign and made it more difficult for individuals with low SES to receive assistance in quitting cigarette smoking and to ultimately be successful in their quit attempts.

FAILURE TO ACCOUNT FOR HOW SMOKER’S MAY REACT TO THE CAMPAIGN

The FDA graphic cigarette campaign falls short in by failing to account for how smokers may react to the campaign. There are three main areas where the FDA has not considered how a smoker might react to the campaign. One area is in failing to account for smoker’s optimistic bias regarding their own health. A second major flaw in the campaign is the failure to consider how the Illusion of Control Theory impacts smoker’s decision to quit. Lastly, the FDA graphic cigarette warnings run the risk of invoking psychosocial reactance from the smokers due to the way in which the warnings are presented.

Optimistic bias is a phenomenon that was captured by Neil Weinstein in series of two studies where he examined the unrealistic optimism that college students had about future life events. Weinstein’s experiment was to ask college age students to estimate their own likelihood of experiencing 42 different life events and to contrast this with the likelihood that one of their classmates would experience these same life events (25). Weinstein discovered that college students tended to rate their own chances of having a positive life event happen to them more highly than that of their classmates; while rating their own chance of having a negative life event occur considerably lower than that of their classmates. In this same article Weinstein had smokers rate their chances for developing smoking-related illnesses; smokers thought they were only “a bit higher” than average when in fact their actual risk of developing lung cancer is as much as 10 times that of a nonsmoker (25). The notion of optimistic bias influences how a smoker perceives their own health risk from smoking. A major weakness of the campaign by the FDA is that it assumes that when individuals are presented the risks of smoking via the graphic warnings that they consider that these health risks have the potential to happen to them however we know from Weinstein’s research that merely understanding that there are health risks is not enough; individuals have to have the belief that these health risks from smoking could happen to them. The FDA campaign merely presents the health risks from smoking, but does not complete the message by demonstrating how this could happen to an individual smoker.

The Illusion of Control theory centers on the idea that individuals believe that they have control over events when in reality they have no control (26). Even when informed with the health risks, smokers tend to overestimate their ability to quit, misjudging the addictiveness of smoking (27). A separate study measured risk perceptions and control as well as behavior and attitudes of smokers and non-smokers; finding that 60% of adolescent and 48% of adult smokers believed that they “could smoke for a few years and then quit” if they wished (28). This is a classic example of illusion of control theory. Cigarette smoking takes place one cigarette at a time, and although young smokers know that years of smoking carries a high health risk, they (cigarette smokers) believe that they can “get away with some lesser amount of smoking before the risk takes hold” (29). The health belief model being used by the FDA as part of the graphic cigarette warning campaign uses fear to demonstrate the consequences of smoking and to drive individuals to quit smoking while a few of the images (the woman smoking outside in the rain) begin to hint at cigarettes taking away your control, the campaign does not go far enough and in general the campaign does not put into perspective just how addictive smoking is.

One potential concern for the FDA is the psychological reactance that smokers may experience as a result of the graphic warning on cigarette pack intervention. When smokers think that a freedom is threatened they experience reactance, a motivational state aimed at restoring the threatened freedom, psychological reactance has also been termed the ‘boomerang effect’ (30). Several different studies have demonstrated the methods smokers have taken to avoid being subjected to the graphic images with a third of the smokers attempting to cover the warning labels, using different cases for their cigarettes, or requesting a specific package to avoid the warning labels (31-32). But both of these studies found that trying to avoid the graphic warnings resulted in greater effectiveness of the warnings on intention to quit. However, there is some evidence that there is a boomerang effect in the U.S. population when subjected to graphic warning labels. In a study of the effect of Canada’s graphic warning labels on U.S. college students, it appeared that the location and size of the warning message were as important as the graphic pictures on the cigarette packages (33). In a separate study comparing U.S. and Canadian’s exposure to graphic warning labels, the U.S. population reported higher smoking intentions after being exposed to the labels (34). Both of these studies suggest that the U.S. population may react differently when exposed to the graphic warnings when compared to other countries.

DESIGINING AN IMPROVED PUBLIC HEALTH CAMPAIGN

The above discussion focused on three major flaws of the FDA anti-smoking campaign through utilization of graphic images on cigarette packs and advertisements. The three major flaws centered on the utilization of the health belief model, failure to include resources that can help smokers quit smoking and failure to consider the impact of the FDA campaign on smokers. The FDA campaign could be redesigned to eliminate these flaws by re-framing the message being delivered via the graphic images to focus on the health benefits of quitting smoking rather than the health risks of continuing smoking. In addition, the campaign could also provide information on the cigarette packs and advertisements on where a smoker could go to receive assistance should they decide to quit. Lastly, the campaign could attempt to individualize health messages by a number of techniques described below. While the FDA graphic cigarette campaign has demonstrated some positive results in other countries most public health campaigns have found that other interventions can be far more effective. According to one meta-analysis, the two of the most effective interventions on smoking have been ones that focused on the environment of smoking rather than on the individual and through raising taxes on cigarettes. A final suggestion for an improved campaign is to combine the fear-based campaign being used by the FDA as one phase of a larger campaign which combines fear-based and gain-based messages. In an ideal world, these three ideas could be employed combined with support information to yield the most effective campaign.

The weakness of the FDA campaign in it’s utilization of the health belief model is that it focuses on the severity of risk portion of the health belief model while other portions (perceived barriers and susceptibility) have shown much more influence at effectively getting people to change their behaviors (14). An alternative to the current FDA campaign would be to focus much more on quitting smoking; including emphasizing the positive health impacts of quitting smoking (35). The campaign could further benefit from using what Strahan calls ‘gain-framed’ messages, where the focus is placed on the positive consequences from abstaining in a risky behavior (35). In one such study by Scheneider et al, they found that gain-framed messages presented in a visual or auditory modality significantly shifted smoking-related beliefs, attitudes, and behavior toward those of health promotion and illness prevention, compared to loss-framed messages (36). According to Witte et al, strong fear-based campaigns are only effective if they include equally strong self-efficacy support that is aimed at convincing smokers that they are able to quit (15). The campaign could even use a ‘Push/Pull’ approach where the first part of the campaign motivates people to change while the second part provides them with a way of achieving it (22). The FDA campaign should be re-designed to create include more gain-framed messages and to provide smokers with strong self-efficacy support.

The FDA campaign does not currently include any information on what resources are available to smokers who wish to quit smoking. Other graphic warning campaigns have included the smoking quit line and seen record number of individuals contacting the quit line with Australia experiencing 3.5 times the normal call volume immediately after their unveiling of the graphic warnings (16). Countries have also reported seeing enhanced numbers of lower SES individuals seeking assistance quitting after including the quit line in conjunction with cigarette warning labels (17). Still, other countries such as Canada have gone even further as to include specific recommendations on the backs of cigarette packs on how to quit smoking and the steps needed to take action (35). Even the World Health Organization guidance indicates that “graphic” information should be accompanied by supportive smoking cessation information (37). The FDA campaign could certainly include the quit line or the method being employed by Canada in their warnings this seems to be a simple yet effective way to deliver the both increases in self-efficacy and relevant information for smoker’s literally in the palm of their hands while increasing the power of the intervention in being able to reach those with lower SES.

The campaign should be designed to deliver individualized health messages about people’s health from smoking. As mentioned previously, smokers believe that they smoke too few cigarettes or haven’t smoked long enough to have resulted in serious risks to their health (38). One potential for individualizing the impact of smoking on health is to provide smokers with their lung age; in one such study Forced Expiratory Volume (FEV) was used to determine smoker’s lung age, this study resulted in a reduction in smoking prevalence and cigarette’s smoked per day in the intervention group (39). Other campaigns such as the “sponge” campaign where a sponge filled with tar is used to demonstrate how much tar is in a year’s worth of cigarette’s winds up in someone’s lungs provide a salient reminder of the health impact’s from smoking; this campaign was extensively piloted to ensure it’s effectiveness (12). In both of these cases anti-smoking campaigns must resonate with the individual smoker in order for a smoker to realize their personalized risk of smoking, campaigns such as these help to overcome the optimism bias that smokers experience.

Comprehensive smoke-free legislation and increases in taxes of cigarettes are two effective means of decreasing cigarette consumption. The World Health Organization (WHO) and other countries have reported that the creating of smoke-free restaurants, bars, and other public establishments has resulted in smoker’s smoking 2-4 less cigarettes per day (12). Ireland found that smokers reported that smoke-free legislation helped them quit and maintain cessation (12). States in the United States that have enacted comprehensive smoke-free legislation resulted in up to a 20% per capita reduction in cigarette consumption compared to states which had not enacted comprehensive smoke-free legislation (12). In addition to smoke-free legislation, the WHO has indicated that increasing the price of tobacco products through significant tax increases is the single most effective way to decrease tobacco use and to encourage current users to quit, keeping kids from taking up smoking and reducing use among the poor (12). California found that cigarette tax increases were four times more effective at reducing cigarette sales than media campaigns (40). These techniques would influence the illusion of control that smokers have, by limiting the environmental circumstances surrounding where and how often they are able to smoke.

Designing any campaign would not be complete without some attempt of minimizing the psychological reactance resulting from the messages delivered by the campaign. In general this campaign should use story-telling by peers to minimize psychological reactance to campaigns (27). In a study by Biener et al, the most effective anti-tobacco ads were ones that evoked strong negative (fear or sad) emotions and that conveyed a thought-provoking and believable message about the serious long-term consequences of tobacco use (41). Our campaign should incorporate both of these principles using peer’s story-telling to deliver thought-provoking and believable messages of the consequences of tobacco use. Hopefully, through utilization of these techniques the psychological reactance from the campaign can be minimized.

An improved anti-smoking public health campaign should include several elements. The campaign should focus on delivering both fear-based (such as the FDA graphic photo campaign) and gain-framed messages so as to spur individuals to action but also provide motivation for taking action as well. All of the messages delivered during the campaign should utilize story-telling from peers as a means of reducing the psychological reactance associated with the messages being delivered. Lastly, each portion of the campaign should include smoking cessation information such as a quit line, or methodology for how to go about quitting. Combining these methods together could result in a more effective campaign that reaches a much more diverse audience than the FDA campaign as currently designed.

REFERENCES

1. Fong GT, Hammond D and Hitchman SC. The impact of pictures on the effectiveness of tobacco warnings. Bulletin of the World Health Organization 2009; 87:640-643.

2. Levy, DT, Chaloupka F, Gitchell J. The Effects of Tobacco Control Policies on Smoking Rates: A Tobacco Control Scorecard. Journal of Public Health Management Practice 2004; Volume 10, 4:338-353.

3. Department of Health and Human Services: Food and Drug Administration. Required Warnings for Cigarette Packages and Advertisements. Federal Register 2010; Volume 75 218: 69524-69565.

4. Department of Health and Human Services. HHS announces new tobacco strategy and proposed new warnings and graphics for cigarette packs and advertisements. Washington, DC. Department of Health and Human Services. http://www.hhs.gov/news/press/2010pres/11/20101110a.html.

5. Rosenstock IM. Historical Origins of the Health Belief Model. Health Education Monographs 1974; Volume 2, 4: 328-335.

6. Salazar MK. Compairison of Four Behavioral Theories. American Association of Occupation Health Nurses Journal 1991; Volume 39, 3: 128-135.

7. Rosenstock IM, Stretcher VJ, Becker MH. Social Learning Theory and the Health Belief Model. Health Education Quarterly 1988; Volume 15, 2:175-183.

8. Weinstein ND. Testing Four Competing Theories of Health-Protective Behavior. Health Psychology 1993; Volume 12, 4: 324-333.

9. Bandura A. Self-efficacy: Toward a Unifying Theory of Behavioral Change. Psychological Review 1977; Volume 84, 2: 191-215.

10. Shiffman S, Balabanis MH, Paty JA, Engberg J, Gwaltney CJ, Liu KS, Gnys M, Hickcox M, Paton S. Dynamic Effects of Self-Efficacy on Smoking Lapse and Relapse. Health Psychology 2000; Volume 19, 4: 315-323.

11.Wakefield MA, Durkin S, Spittal MJ, Siahpush M, Scollo M, Simpson JA, Chapman S, White V, Hill D. Impact of Tobacco Control Policies and Mass Media Campaigns on Monthly Adult Smoking Prevalence. American Journal of Public Health 2008; Volume 98, 8: 1443-1450.

12. World Health Organization. WHO Report on the Global Tobacco Epidemic, 2009: Implementing smoke-free environments. Geneva, Switzerland. World Health Organization 2009.

13. Fowkes FJI, Stewart MCW, Fowkes FGF, Amos A, Price, JF. Scottish smoke-free legislation and trends in smoking cessation. Addiction 2008; 103: 1888-1895.

14. Janz NK, Becker MH. The Health Belief Model: A Decade Later. Health Education Quarterly 1984; Volume 11, 1: 1-47.

15.Witte K, Allen M. A Meta-Analysis of Fear Appeals: Implications for Effective Public Health Campaigns. Health Education & Behavior 2000; Volume 27, 5: 591-615.

16. Miller CL, Hill DJ, Quester PG, Hiller JE. Impact on the Australian Quitline of new graphic cigarette pack warnings including the Quitline number. Tobacco Control 2009; 18: 235-237.

17. Willemsen MC, Simons C, Zeeman G. Impact of the new EU health warnings on the Dutch quit line. Tobacco Control 2002; 11: 380-382.

18. Li J, Grigg M. New Zealand: new graphic warnings encourage registrations with the quitline. Tobacco Control 2009; Volume 18, 1: 72.

19. Anderson CM, Zhu SH. Tobacco quitlines: looking back and looking ahead. Tobacco Control 2007; Volume 16, Supplement I: i81-i86.

20. Borland R, Segan CJ, Livingston PM, Owen N. The effectiveness of callback counseling for smoking cessation: a randomized trial. Addiction 2001; Volume 96, 881-889.

21. U.S. Department of Health and Human Services, Public Health Service. Treating Tobacco Use and Dependence – Quick Reference Guide for Clinicians 2008 Update. U.S. Department of Health and Human Services 2009. 1-40.

22. Miller CL, Wakefield M, Roberts L. Uptake and Effectiveness of the Australian telephone Quitline service in the context of a mass media campaign. Tobacco Control 2003; Volume 12, Supplement II: ii53-ii58.

23. Tomsen T, Helgason AR, Gilljam H. Quitline in smoking cessation: A cost-effectiveness analysis. International Journal of Technology Assessment in Health Care 2004. Volume 20, 4: 469-474.

24. Siahpush M, McNeill A, Hammond D, Fong GF. Socioeconomic and country variations in knowledge of health risks of tobacco smoking and toxic constituents of smoke: results from the 2002 International Tobacco Control (ITC) Four Country Survey Tobacco Control 2006; Volume 15, Supplement III: iii65-iii70.

25. Weinstein ND. Unrealistic Optimism About Future Life Events. Journal of Personality and Social Psychology 1980; Volume 39, 5: 806-820.

26. Langer EJ. The Illusion of Control. Journal of Personality and Social Psychology 1975; Volume 32, 2: 311-328.

27. Wolburg JM. Misguided Optimism Among College Student Smokers: Leveraging Their Quit-Smoking Strategies for Smoking Cessation Campaigns. The Journal of Consumer Affairs 2009; Volume 43, 2: 305-331.

28. Arnett JJ. Optimistic Bias In Adolescent and Adult Smokers and Nonsmokers. Addictive Behaviors 2000; Volume 25, 4: 625-632.

29. Slovic P. Cigarette Smokers – Rational Actors or Rational Fools? In: Slovic, P. ed. Smoking: Risk, perception, and policy. Thousand Oaks, CA: Sage. 2001.

30. Brehm JW. A theory of psychological reactance. New York, NY Academic Press. 1966.

31. Hammond D, Fong GT, McDonald PW, Brown KS, Cameron R. Graphic Canadian Cigarette Warning Labels and Adverse Outcomes: Evidence from Canadian Smokers. American Journal of Public Health 2004; Volume 94, 8:1442-1445

32. Borland R, Wilson N, Fong GT, Hammond D, Cummings KM, Yong HH, Hosking W, Hastings G, Thrasher J, McNeill A. Impact of graphic and text warnings on cigarette packs: findings from four countries over five years. Tobacco Control 2009; 18:358-364.

33. Kempf DS, Harmon SK. Examing the Effectiveness of Proposed Cigarette Package Warning Labels with Graphic Images Among U.S. College Students. Academy of Marketing Studies Journal 2006; Volume 10, 2: 77-93.

34. Sabbane LI, Lowrey TM, Chebat JC. The Effectiveness of Warning Label Threats on Nonsmoking Adolescents. The Journal of Consumer Affairs 2009; Volume 43, 2: 332-345.

35. Strahan E J, White K, Fong G T, Fabrigar L R, Zanna M P, Cameron R. Enhancing the effectiveness of tobacco package warning labels: a social psychological perspective. Tobacco Control 2002; 11:183-190.

36. Schneider TR, Salovey P, Pallonen U, Undorfa N, Smith NF, Steward WT. Visual and Auditory Message Framing Effects on Tobacco Smoking. Journal of Applied Social Psychology 2001; Volume 31, 4: 667-682.

37. World Health Organization. Guidelines for implementation of Article 11 of the WHO Framework Convention on Tobacco Control. World Health Organization, Geneva, Switzerland. http://www.who.int/fctc/guidelines/article_11.pdf

38. Weinstein ND, Marcus SE, Moser RP. Smokers’ unrealistic optimism about their risk. Tobacco Control 2005; 14: 55-59.

39. Parkes G, Greenbaugh T, Griffin M, Dent R. Effect on smoking quit rate of telling patients their lung age: the Step2quit randomised controlled trial. BMJ 2008; 1-7.

40. Hu TW, Sung HY, Keeler TE. Reducing Cigarette Consumption in California: Tobacco Taxes vs an Anti-Smoking Media Campaign. The American Journal of Public Health 1995; Volume 85, 9: 1218-1222.

41. Biener L, Ji M, Gilpin EA, Albers AB. The Impact of Emotional Tone, Message, and Broadcast Parameters in Youth Anti-smoking Advertisements. Journal of Health Communications 2004; Volume 9: 259-274.