Sunday, January 2, 2011

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.


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