Placebo Effects and Direct-to-Consumer Advertising

Co-authored by Lily Johns of the University of Michigan

In 2023, 61 percent of adults reported taking prescription medications, with more than one-quarter of those respondents taking four or more. While most Americans believe increased access to prescription drugs improves quality of life, these medications come at a high cost to patients. Estimates from 2021 show that Americans spend $1,432 on prescription drugs per capita (including $164 in out-of-pocket costs), vastly exceeding per capita spending in other high-income countries. Additionally, how much people pay depends significantly on their insurance coverage, with high out-of-pocket costs falling most heavily on Medicare enrollees and those without health insurance. Such costs present a barrier to care for many Americans. In fact, three in ten Americans report not taking their medications as prescribed, such as skipping or rationing their doses, due to high costs.

Prescription drug affordability and accessibility are key health policy issues, especially for older adults and those with chronic conditions, who take more medications. While prescription drug costs are affected by many factors, one key issue in this conversation is the process of marketing prescription drugs to the general public, or direct-to-consumer pharmaceutical advertising.

What Is Direct-to-Consumer Pharmaceutical Advertising?

Direct-to-consumer pharmaceutical advertising (DTCPA) is the process of marketing pharmaceutical products directly to consumers. Widespread DTCPA (i.e., those including product claims) is only permitted in two nations: the U.S. and New Zealand. DTCPA is one of the most lucrative and rapidly growing forms of advertising in the U.S., with annual expenditures for prescription drug ads increasing from $1.3 billion (roughly 79,000 ads) in 1997 to $6 billion (about 4.6 million ads) in 2016. In 2022, the top 10 most heavily advertised drugs alone accounted for $1.68 billion in TV promotional spending.

DTCPA has only been legal in the U.S. since the 1980s, when the first example entered the market with a TV ad for Rufen (prescription-strength ibuprofen) in 1983. Prior to this, pharmaceutical companies advertised their products using non-branded public service announcements that mainly targeted physicians. Following a temporary moratorium on DTCPA from 1983 to 1985, the FDA relaxed regulations on DTC ads in 1997. These new regulations required ads to include a major statement that reports the medication’s "major risks," and identify an external source with more detailed information on the risks and side effects associated with the drug or treatment, giving way to the advertisements that we see today.

A (Highly Debated) Mode of Health Communication

Apart from the FDA, academics, advocacy groups, and policymakers have continuously debated the efficacy of DTCPA as a means of consumer education. Proponents argue that these advertisements educate consumers by raising awareness of health conditions and available treatments, encouraging them to seek help for symptoms that they may be having. On the other hand, critics argue that DTCPA as a method of health education is inherently flawed due to the underlying goal of any advertising: to sell products. Groups such as the American Medical Association have called for a ban on DTC ads for prescription drugs.

Despite these debates, it is important to note that these ads are, in fact, a key mode of health communication in the U.S. Estimates show that consumers are exposed to an average of 16 hours per year of DTCPA, which is more time than the average person spends at the doctor’s office. Irrespective of arguments for or against DTCPA, a majority of people in the U.S. engage with these ads and retain their information, biased or not.

A Tool to Shape Consumer Expectations

Not only do DTCPA ads communicate information about health conditions and available treatments, but they also influence patients' expectations of the risks and benefits of a medication and, therefore, behavior regarding that medication. From the perspective of a pharmaceutical company, an effective DTC ad is one that results in more sales of the drug or treatment, and the primary goal of these advertisements is to prompt you, the (potential) patient, to request a prescription from your doctor. This is reflected in the content of the ads, which research has shown systematically maximizes the benefits and minimizes the risks associated with the drug. For example, the major statements (i.e., the segments that present the drug or treatment’s major risks) included significantly more virtually complex imagery and positive facial expressions that aim to distract the viewer and inhibit their understanding of the information presented.

Research has also shown that less implicit content is given to the risks of the drug in comparison to the benefits. The net effect is an advertisement designed to create a positive perception of the drug along with an expectation that taking this drug will improve health and well-being, with minimal risks or side effects.

These positive expectations have an impact on patient behavior. DTC advertisements have been shown to increase information-seeking and specific drug requests, even causing some patients to switch physicians when their drug request following an ad is denied. While advertising can also prompt patients to discuss their health concerns with their doctor and increase patient-physician communication, concerns remain that these advertisements can lead to inappropriate prescribing by discounting the positive effects of lifestyle or behavior changes or more cost-effective alternatives.

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In addition to affecting consumer behavior, these advertisements can also have a direct impact on health: just expecting that a particular drug or treatment will work can actually improve your treatment outcomes, for some conditions, through the cognitive bias known as the placebo effect.

Expectations and the Placebo Effect

Contrary to popular belief, a placebo, which is essentially a ‘fake’ drug or treatment (e.g., a sugar pill), is not just an inert substance that has no physiologic impact. Rather, placebos can induce a biopsychosocial phenomenon called the placebo effect that shares some of the same biochemical pathways that are modulated by ‘active’ drugs and related pharmacological intervention. The placebo effect is fundamental to medical treatment: it is one of the reasons almost all medications are tested against placebos in randomized controlled trials in order to demonstrate their effectiveness and safety, where the literal statistical comparison that is being made is: “Is this active medication more effective at treating symptoms (than the placebo is)?” and “Does this active medication produce more adverse side-effects (than the placebo does)?”

Placebo effects are positive outcomes that cannot be scientifically explained by the physical effects of the treatment. These positive outcomes stem from the context of the clinical encounter, the ritual of taking a mediation, and the existing patient-physician relationship (e.g., trust, communication), which all contribute to the patient’s expectation that the treatment will be effective. That expectation can translate into actual therapeutic benefit, particularly for psychiatric, gastrointestinal, pain syndromes, and neurological conditions. In other words, if you were being prescribed an antidepressant for depressive symptoms, factors such as how your doctor describes the drug and its side effects, as well as how much you trust your doctor, can tangibly affect your response to the drug.

Shaping Expectations Through DTCPA as a Way to Enhance the Placebo Effect

The implicit goal of DTCPA is to create a positive context about the drug before you ever discuss the treatment with your doctor. Research suggests that the positive expectations created by advertisements can enhance a placebo response in a clinical setting. This contrasts with the role that the placebo effect plays in drug trials, where trials are often designed to minimize the placebo effect. For example, some trials institute a “placebo wash-out” period, where all participants are initially given a placebo to evaluate their response and, in some cases, to exclude those who are “high placebo responders” from the subsequent active drug trial.

While research is currently limited, DTCPA represents a unique case in which to study the placebo effect and the ways in which societal forces can affect our health and decision-making. In the next post, we will discuss what upcoming FDA changes to DTCPA regulations may mean for the placebo effect.