Talking with Kathryn Aikin, Ph.D., who is a Senior Social Science Analyst and Research Team Lead in the Office of Prescription Drug Promotion, Office of Medical Policy, CDER.
In the past, prescription drug makers typically marketed their drugs only to health care professionals. In the 1980s and early 1990s, companies began to market their products to consumers through direct-to-consumer (DTC) ads, via both print and broadcast media. The Guidance for Industry on Consumer-directed Broadcast Advertisements (finalized in 1999), clarified how a company may fulfill the “adequate provision” obligation for broadcast ads. This obligation stated that, in addition to including important risk information, broadcast ads should describe the sources a consumer can use to find complete prescribing and risk information for the drug.
CDER’s Office of Prescription Drug Promotion (OPDP) is charged with ensuring that prescription drug marketing information is truthful, balanced and accurately communicated. Senior Social Science Analyst and Team Lead Kathryn Aikin, Ph.D., describes the research conducted in support of OPDP’s mission.
Let’s start with a brief description of what your team does and how it supports the mission of the Office of Prescription Drug Promotion.
We are a research team of social psychologists. Our program is designed to investigate both applied questions, or real life questions, and theoretical questions in the area of prescription drug promotion. We look at DTC ads, as well as materials designed for health care professionals. Our job is to support the agency’s goal of providing science-based information and maintaining its commitment to public health. We provide social science data meant to inform regulatory actions or guidances. Sometimes we offer advice to companies on their DTC materials before they disseminate them, but only at their request. That is completely voluntary.
Why is this type of social science research important?
Social science has a long history of providing input for making informed decisions in government. Social science research helps us to conceptualize issues, and to see how policies may be having an impact on the public. It is necessary to evaluate the effectiveness of programs to determine if they are having the intended effect, or an unintended effect. Social science research can also provide empirical data upon which to make decisions.
How do you determine what questions to focus on?
We get ideas for studies from a variety of sources. We may design a study to investigate an emerging issue. We might investigate issues of longstanding interest to the agency that haven’t previously been studied. In some cases, we are mandated by law to study an issue. For instance, we were mandated to study the impact of including a toll-free number in consumer advertising for the reporting of side effects. We may also take a second look at existing issues so as to verify previous conclusions or add more empirical data.
What methods do you use to conduct your studies? For example, do you use surveys or interviews?
We use a variety of methods. The research method chosen depends on the type of research question that we are trying to answer. We use qualitative methods—like focus groups and interviews—to generate ideas and investigate a problem on a general level. Qualitative studies are a good way to guide our thinking and tell us what we should be studying quantitatively. For our quantitative studies, we conduct surveys, which provide a snapshot of a moment in time. We also conduct experimental research, in which we can randomly assign a set of participants to a condition (e.g., the situation we are studying), and a set of participants to a control group for comparison, to identify any cause-and-effect relationships. We design and conceptualize these studies and work with data collection firms to execute the studies among real-world consumers. The firms collect the data, and we analyze it in conjunction with them, and write about it for peer-reviewed publication.
What are some key findings from your studies that you have found to be striking or surprising?
To do science is to venture into the unknown. Sometimes we find what we are looking for and sometimes we don’t. When we find something unexpected, that is when science takes off. It is those unexpected things that prompt us to think more about the issues. That is exciting to me.
One surprising finding is how little time consumers spend reading the brief summary, which is usually the second page in a print ad that presents risk and other safety information. We found that many people spend just seconds reading that.
In another recent experimental study, we showed people a print ad that included two statements. One statement compared prices between two drugs, e.g., that this drug costs less than another drug. The second statement—known as a context statement---noted that the two drugs had not been compared for safety and efficacy and therefore should not be considered equivalent. We placed the context statement right next to the price comparison statement. Nonetheless, half of our participants did not see the context statement, despite its prominence. That was surprising to me. These results raise issues about context, disclosures, and how much information we can expect people to see and understand in an ad.
DTC prescription drug ads are pervasive in our culture. What effects do these ads have on people who view them? Do consumers perceive these ads differently than health care professionals?
When the guidance was finalized, the agency was concerned about how these ads might impact demand for prescription drugs, but we were also concerned about how they may affect the doctor-patient relationship. So we did surveys in 1999 and 2003 to see what impact they might have among consumers and providers. We found that there were some people who went to their doctor to ask for a particular drug after seeing the ad, but not that many. Similarly, some physicians felt pressured to prescribe, but not that many. Significantly, the ads tended to increase awareness of available treatments among both consumers and providers. We also found that both consumers and physicians felt these ads did not include enough information about either risks or benefits. We are planning to repeat this survey with consumers to see if attitudes have changed since the last survey.
In addition, people often complain about the amount of information in these ads—that there either is too much or too little. It is possible that the problem is not the amount of information, but instead the type of information given. We need to look further at the information that is presented, and, rather than adding more information, find a way to make it more relevant. Currently, we are examining the major statement of risks made in broadcast ads. We want to see if including only those risks that are severe, serious or actionable will make a difference in consumer comprehension. If you give people information that they can do something about or easily recognize, maybe it will be better understood.
What other research is in progress or on the horizon?
We have several research projects in progress. Many are focused on how viewers understand or comprehend the information being presented.
In one study of print ads, we are looking at how data about the effectiveness of a drug is described. We are examining whether consumers and health care professionals understand it, as well as if they can recognize if it is potentially misleading. Health care professionals in particular, see this type of information frequently.
A study of broadcast ads is looking at aspects of how quantitative information is presented, e.g., data about how well a product works, data about the likelihood of risks, and visual representations of efficacy. We want to better understand the impact of this information on understanding of risks and benefits.
Another study is looking at the use of animation, and whether it influences how people view the benefits and risks of a product. For instance, does an animated character make a product seem less risky, or does it have any effect on perception of risk at all? We also conducted an eye-tracking study of people watching a broadcast ad to determine whether or not distracting images had an effect on comprehension. We found that distracting images drew people’s attention away from superimposed risk information in text, which decreased their retention of the product’s risk.
Finally, our research shows that including important information both verbally and in writing (e.g., in the audio and visual parts of the ad) can increase viewer comprehension. This is the concept of “dual modality”—if you are both hearing and seeing important information, you are more likely to understand and remember it.