Sunday, May 9, 2010

Hey FDA, Do Your F*CCing Job! Direct-to-Consumer Pharmaceuticals, How Pharmaceutical Companies Inappropriately Advertise Their Drugs –SC


Since the advent of the industrial revolution in the 19th century, marketing has become increasingly more influential in shaping our world views, purchasing attitudes, cultural and social norms, and even the definition of what is American. (1) Using a theory known as marketing theory, companies sell their products by appealing to truths and making promises rather than presenting figures and empirical evidence of the product. As the scope of advertising increases, using recent advances in the studies of social behavior and psychology, it is pivotal the public health community and the regulatory agencies of the United States, including the Federal Communications Commission (FCC) and the Federal and Drug Administration (FDA), evaluate and readdresses the current standards of safety and acceptable content of our advertisements. This critique will focus specifically on how direct-to-consumer (DTC) advertising of pharmaceutical drugs inappropriately influences consumption and is not being properly regulated by the responsible agencies. Following the critique, this essay attempts to offer a more clinically acceptable method of providing consumer information on drugs based on the principles of social and behavioral sciences.

Arguably the most important right in a functioning democracy is freedom of speech. The founders of the United States of America knew full well the paramount importance of these rights bestowed on the people of the newly fledged nation, as is exemplified by the fact that freedom of speech is the first amendment in the bill of rights. However, set by precedents of the Supreme Court, not all speech is allowed in this country. There are limitations on factitious offers in commercial speech, hate speech which can insight violence, obscenity, and speech explicitly inciting forcible coups of the government to name a few. Currently under the heading of the public health there are restrictions and regulations on freedom of speech that extend beyond the prevention of inciting violence, including the Public Health Cigarette Smoking Act which banned cigarette advertisements on American radio and television, and Federal Cigarette Labeling and Advertising Act of 1965. (2)(3) These laws were passed with the intention of protecting the public from speech deemed deleterious to the health of Americans.

The FCC was established by the Communications Act of 1934 and is charged with regulating interstate and international communications by radio, television, wire, satellite and cable. While traditionally not viewed as a public health social agency, the FCC does provide services in the realm of public health such as responsibility of emergency broadcasting and preventing violence from hate speech (or cartoons of the prophet Muhammad). As stated in a mission statement of the FCC, the commission was created "for the purpose of promoting safety of life and property through the use of wire and radio communications."(4)

Traditionally, it has fallen on the FDA to regulate advertisements of pharmaceutical prescription drugs. From a voluntary moratorium put on all ads in 1985 to a proposed rule to further regulate DTC advertisements in the March 29, 2010 Federal Register, DTC advertisements have been controversial. The current rules, from the Federal Food, Drug, and Cosmetic Act, regulating DTC broadcast advertisement for a prescription drug must contain a “major statement” of the “major side effects and contraindications” of the drug, along with identification of means to obtain the approved labeling for the advertised product. The “major statement” is required to be “comparable in prominence and readability to the presentation of effectiveness information in the advertisement.”

Three years ago, The Food and Drug Administration Amendments Act of 2007 (“FDAAA”) was passed by congress. This act requires “[i]n the case of a prescription drug subject to section 503(b)(1) presented directly to consumers in television or radio format and stating the name of the drug and its conditions for use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous and neutral manner.” Section 901(d)(3)(A) of FDAAA. (5) The FDA is currently creating guidelines how to implement the act, specifically regarding the “clear, conspicuous and neutral manner.”

Government intervention of free speech, rightfully so, is a highly politically charged and serious issue. Intervention will require leadership from many different walks of life, including the research community, health advocate groups, and consumer protection agencies.

Critique A – Marketing Theory: Marketing Health or Illness?

The United States is one of two industrialized countries that allow pharmaceutical companies to advertise directly to consumers. Many of the issues presented in this critique are endemic in all pharmaceutical commercials; however, do to the somewhat subjective and definitely controversial nature of medicating mental health disorders, depression will be the primary focus of this critique.

Depression and Anxiety disorders are becoming an epidemic. As of 2004, one in ten American women takes an antidepressant and adult use of antidepressants almost tripled between 1988-1994 and 1999-2000. (6) The current marketing technique for selling antidepressant medication, as with all pharmaceutical ads, is deeply entrenched in the beliefs of marketing and advertising theory, framing and the predictably irrational response to context(discussed in critique B), and social norms theory (discussed in critique C).

Depression commercials inevitably depicts an individual, usually a woman, looking extremely agitated; sad, dramatic music plays softly in the background as an unseen narrator describes the symptoms of depression. The narrator then introduces the magic happy pill; the sun comes out from behind the clouds, and poof all the poor woman’s symptoms have vanished. She is complete. She is then depicted doing the things she loves: playing with her children, having a romantic dinner, being successful at work. Finally, a long list of adverse reactions to the medication is read pleasantly by the narrator; or worse yet, our heroine lists the dangerous side-effects over a cup of coffee with her best friends.

The origins of marketing theory are crucial in understanding the thinking that has led to pharmaceutical companies paying for such commercials. Marketing theory was born from the industrial revolution; where for the first time, scarcity of products was a minimal issue for corporations. Rather, the greatest issue facing business was finding new consumers to meet the increase in supply of their products. From this basic economic need, our American culture of consumerism was birthed, using marketing theory as the tool to disseminate this new way of life. The aim of marketing theory, as stated earlier, is not simply to present the product and its specifications to its intended audience; instead, its central belief is a consumer will purchase a product when certain instincts, or core values, are properly and scientifically addressed. In creating a new consumer for post-industrial America, “the advertisers were concerned with effecting a self-conscious change in the psychic economy, which could not come about if they spent all their time talking about a product and none talking about the “reader”.”(1)

In order to accomplish such a task, advertising is designed to make a promise that a core value, which otherwise would not be met, will be fulfilled with the purchase of the product. The promise in pharmaceutical commercials predictably always include the core value of better health, however, additional promises often depicted are freedom, fearlessness, happiness, and often romance and love among many others. The Viagra commercial isn’t selling erections, they are selling love; the anti-depression commercial isn’t selling alleviation of depression symptoms, they are selling the joy of motherhood, rekindled romance, and a promotion.

Herein lies the problem; medical decisions, we like to believe, are purely clinical, and should be devoid of subjective determinants like feelings and unreal promises. Then why go through all the fuss of finding the proper looking actress and adorable kids, the perfect music, and the thousands of dollars of research that goes into the creation of these commercials? The answer obviously is sales increase. The question that needs to be addressed by regulators is this: should pharmaceutical advertisements be allowed to target emotions and core values rather than simply presenting the information as was intended when they were again allowed to advertise in 1997?(7) An increasing body of knowledge has observed that these commercials provide very limited educational value, while at the same time misconceptions of the factuality of statements and safety of the product are abundant. (8) Equally disturbing, the FDA is very limited in their oversight of the commercials under current regulations because of staffing increases not meeting the increases in DTC spending, limited resources, and little political pressure. As a result from 1999 to 2004, FDA review of broadcast advertisements before airing fell from 64% to 32%.(9)(10) Furthermore, the FDA’s new proposed standards of the FDAAA do nothing to address the emotional tactics used per marketing theory.

Critique B - Companies dressed as doctors, dressed as friends. How context and framing influence the marketing of medications

Returning to the hypothetical example pharmaceutical commercial, recall how the major statement (major side effects and contraindications) is presented. In one circumstance the narrator communicates the major statement while video played; in the other, actors pretend to warn each other as they state the major statement. There is yet a third way which pharmaceutical companies display the major statement, where actors, sometimes dressed as doctors, address the viewer directly warning of the side effects. Lastly, there is the time honored tradition of fine print.

The new proposed standards of the FDAAA are as follows:

1. Information in the major statement is presented in language that is readily understandable by consumers; 2. Audio information in the major statement is understandable in terms of the volume, articulation, and pacing used; 3. The text of the major statement is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and

4. The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement. (5)

Unfortunately, the proposal does not state that the major statement needs to be both audio and visual. As you can see, the issue of illegible fine print of the major statement is addressed by the third standard of implementation. The fourth standard, while fairly vague, seems to address the narrator stating the major statement while the characters of the commercial are going about enjoying the benefits of drugs; although an argument for what constitutes detraction is sure to ensue. The two other common methods of presenting the major statement, where actors discuss the major statement with each other or the audience, also should be considered detracting from the communication of the major statement, although a lack of more specific guidelines seems as though it will go unchecked.

Going by the lack of explicit attention given to these methods of presenting the major statement, one would assume that they are innocuous. One would be wrong in thinking that. First off, there is a problem with having actors portraying doctors. There are numerous studies that present the case that humans often act irrationally by ignoring or misinterpreting context. In this situation, the commercials are presenting an actor in the context, or frame, as a doctor; and not just any doctor, but your doctor as he is offering you (the viewer) medical advice. By having a doctor, regardless if a fake, the commercial is framed in a clinical context and the viewer may, based on our likelihood of acting predictably irrational, mistake the advertisement as sound medical advice. Doctors in the commercials may also account for the perception that drugs in commercials are safer and more highly regulated than in actuality. (8)

Thinking back to the days when doctors were in cigarette commercials, it is unconscionable that a product known now to cause harm was pedaled using the image of doctors. Unfortunately, the reality of the state of pharmaceutical is very troubling and far from the clean cut image presented by the doctors in the commercials. Indicative of the systemic problems throughout the pharmaceutical industry, a recent study published in the New England Journal of Medicine found that negative study results of the efficacy of 12 antidepressant agents were withheld from publication. As a result it “appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.” (11) There is no added benefit from having actors portray doctors, and due to the risk of framing biases, the FDA is amiss in not including an explicit restriction in the FDAAA proposal.

Critique C - Social norms theory: How and Why DTCA influence perceived Prevalence

Self diagnosis is an objective of DTC advertisements. Due to the subjective nature of self diagnosis, it is plausible, and even probable, that healthy individuals mistake normal human experience as symptomatic of illness. (12) “The danger is that by turning ordinary experiences into diagnoses--by designating a runny nose as allergic rhinitis--the boundaries of medicine might become unreasonably broad.”(13) This is especially troublesome for mental health disorders like anxiety and depression. Every individual has a conceptual anchor point of what it is to feel ‘normal’ and what it would be to feel depressed. Although you wouldn’t know it by watching the pharmaceutical commercials, it is normal to be sad sometimes. Through the effects of social norms theory, DTC advertisements are capable of moving the anchor point away from normal, making people question their health, and pushing the already vulnerable into labeling themselves depressed.

The rising numbers of depressed individuals, as well as the astonishing claims that DTC advertising may have lead to the antidepressant treatment in 15-fold as many non-depressed people as depressed people, and 94% of new antidepressant use due to DTCA is from non-depressed individuals is indicative of this occurrence. (14) Considering the distorted perception that DTCA viewers have on prevalence of depression, these findings are not surprising. According to social norms theory “much of people’s behavior is influenced by their perception of how other members of their social group behave… people tend to misperceive, i.e., exaggerate, the negative health behavior of their peers. If people think harmful behavior is typical, they are more likely to engage in that type of behavior.”(15) Stopping short of calling the use of antidepressants and other medications a negative health behavior, the fact that exposure to antidepressant DTCA was associated with higher perceived prevalence of depression, does appear to be reason for concern. (16)

DTC advertisements have evolved to maximize the effect at which the consumer will perceive prevalence of the illness in society. DTCA accomplishes this by the before mentioned methods of delivering the major statement of actors engaging the audience in a discussion and actors addressing each other of the benefits and risks of the drug. In addition to detracting from the major statement, by appearing to bring the illness out into the ‘open’, these commercials lead to the belief that the illness is more common than it is, and that it is typical and normal to have to medicate oneself. Further compounding this issue, a study found that of sampled advertisements only “25% made claims about the population prevalence of the condition, but among these ads, only 25%

gave specific information (eg, 1 in 9). The remaining ads used vague terms, such as millions.””(17)

In not enforcing better representation of the prevalence of an illness, especially for mental health disorders, the FDA unnecessarily allows a social norm that may lead more people, than is clinically indicated to believe they have an illness and seek treatment.

Proposal A: Restrict the Use of Marketing Theory, Replace with Health Belief Model

Marketing theory is appropriate when selling beer, not health. Proponents of DTCA state the benefits are in the educational value of the content, yet these quasi-public service announcements have shown little demonstrative impact in increasing health outcomes. I propose that in line with the first amendment rights of the pharmaceutical companies as well as with the appropriate public health model DTCA should be required to meet, but not exceed, the health belief model (HBM).

The health belief model is an early public health intervention model that is focused primarily on the education and uptake of health services. Unlike marketing theory, the HBM does not rely on manipulation of core values not directly related to health. Instead, the HBM focuses on educating of the perceived susceptibility, perceived severity, perceived barriers, and perceived benefits an individual faces when making a decision regarding healthcare. In doing so, the HBM presents an evidence based appeal for the product, forcing pharmaceuticals companies to disclose more pertinent issues like efficacy of the medication and risks involved with taking and not taking the drug. The HBM has been found useful and effective in public interventions that require simple yes or no answers like the decision to get vaccinated. For this reason, it should be equally effective helping the viewers of DTCA decide if the medication is appropriate for them.

The FDA should require pharmaceutical companies to present a simple written report demonstrating all the HBM criteria has been met, and that there are no emotional appeals for the selling of the product, including in choice of music, provocative narration, and visual cues. The FDA will be relied on heavily to fact check the statements made by the pharmaceutical companies to ensure the viewer is not being deceived as he weighs the perceived benefits and other factors that go into the decision to change ones behavior.

In adopting the HBM, DTCA will have all the benefits of the current commercials minus the bad and manipulative. In doing so, our country, will have a better informed health purchaser, who relies on facts and not misconceptions and promises when making health care decisions.

Proposal B- Ban any Confusion, Use Disclaimers

The issue of context is a serious concern for the viewers of DTCA. The easiest and one of the most important solutions to mistaken context is banning actor portrayals of doctors. This can be accomplished by explicitly adding this provision to the FDAAA. The FDA and FCC have an obligation to protecting the public that exceeds the fine print stating the doctor on the screen is actually an actor. Should this regulation be enforced, the trend may be to use more real doctors in the advertisements. This poses the same threat as does the doctor actors, and if not banned outright should be regulated so as the intentions of the doctor are clear, that he is not giving clinical advice, and that he is attempting to sell drugs.

One way to regulate this, as well as other sources of inappropriate framing, is to require visual and audio disclaimers prior to the airings of the commercials. The content of the disclaimer should be research tested to garner the desired results. Some ideas for reframing the DTC commercials to be used in any combination of ways: simply remind the viewer they are about to watch an advertisement, that the views expressed are that of a pharmaceutical company, that the statements have not thoroughly been evaluated for accuracy of claims, and lastly that it is there doctors job, using his clinical expertise to diagnose them on an individual basis.

Lastly, especially with the advent of the internet, it is important that doctors be given the instruction and incentives to properly instruct their patients on reliable and unreliable sources of health information and tips. Doctors should teach patients to view pharmaceutical commercials in the proper frame and remind them of some of the ploys these ads use. Ultimately, it is the doctor’s decision on the course of a patient’s treatments, but how patients view and digest health information and suggestions is equally important as it is reflective of how successful a doctor will perform his job and keep his patients happy.

Proposal C- Make Prevalence and Intentions Known Using Social Marketing

To combat the social norms theory implications of DTCA there are several things the public health community and the FDA and FCC can do. First and foremost, the FDAAA should include within their regulations prohibitions on actors discussing the major statement between themselves and with the viewer. As both methods are detractors to the major statement, these restrictions should currently be included in the proposed regulations, although explicit mention of these tactics obviously will make enforcing these rules simpler and clearer.

Additionally, the FDA should require in DTCA concrete and accurate information of prevalence of the illness. The prevalence statement if not mentioned within the ad should be included during the major statement in a clear, easy to read and hear manner. Through better understanding of actual prevalence of certain illnesses, the misperceptions and overestimates that lead people to believe what is and isn’t in the realm of social norms, will be mitigated.

From a non-regulatory perspective, social norms theory can also be combated using a social marketing campaign similar to the TRUTH campaigns against the tobacco industry. Social marketing takes methods drawn from behavioral theory, persuasion psychology, and marketing science and applies them to health behavior, human reactions to messages and message delivery. “These methods include using behavioural [sic] theory to influence behaviour that affects health; assessing factors that underlie the receptivity of audiences to messages, such as the credibility and likeability of the argument; and strategic marketing of messages that aim to change the behaviour of target audiences using [place, price, product, and promotion].”(18)

This new counter-marketing campaign would be designed to expose misconceptions and the unsettling business practices of the pharmaceutical companies. The strength of social marketing is presenting the material in a way that harnesses the social norms associated with pharmaceutical drug use and consumption. Social marketing has been effective in the intervention of cigarette smoking and other harmful behavior, its application in a field of health where the new use of antidepressant medications, with their many side effects, is 94% by those who are not depressed is startling evidence that we need change.

The use of a social marketing campaign could also deflect this 94% who have been convinced they have a biological problem into healthier life style choices that could help them emotionally. This campaign can work to address the social factors that may cause anxiety and depression at the group level, rather than at the individual level which has been cornered off by the pharmaceutical companies.


To meet the challenges of marketing, the public health community and the government, need to be weary of the undue influence marketing has on our society. As the debate over DTCA of pharmaceutical drugs continues, it is absolutely critical the question, “why is this being advertised this way?” be asked, and asked frequently. Moving forward, the public health community needs to ask itself, what are the root causes of the epidemic-like increases in the numbers of people taking medication for depression and anxiety, and how can they be addressed. Furthermore, other tactics that have the potential to negatively effect health must also must be studies and intervened on behalf the public: including the effects and implications of fear mongering, the new research into human’s capacity for mimicry and labeling, the practice of targeting low self-esteem and self hate by advertisements, and the negative depictions of aging.


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2. Public Health Cigarette Smoking Act of 1969, Pub. L. 91-222, 84 Stat. 87, as amended, 15 U. S. C. §§ 1331-1340.

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15. Social Norms Research Center.Best Practices: Social Norms. Wisconsin: Social Norms Research Center.

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18. Evans D. How social marketing works in health care. BMJ 2006; 332(7551)

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