The Food and Drug Administration regulates which drugs are approved for manufacture, distribution, sale, and use in America. The FDA’s Center for Drug Evaluation and Research (CDER) reviews many aspects of drug safety including clinical trials and the marketing and promotion of drugs. CDER’s work isn’t limited to medications.
CDER’s general duties include:
- “Overseeing prescription drugs, generic drugs, biosimilars, and over-the-counter drugs.
- Using science and data to ensure drug safety, quality, and efficacy.
- Streamline the drug development process and ensure drugs are safe and effective.
- Providing drug information for consumers and patients, health care providers and professionals, industry, and more
- Making recommendations to update drug labeling.
- Providing drug information for consumers and patients, health care providers and professionals, industry, and more.
- Making recommendations to update drug labeling.”
Many products that consumers use that qualify as drugs include such products as fluoride toothpaste, dandruff shampoos, sunscreens, and antiperspirants.
What is conflation?
The FDA writes that pharmaceutical companies that promote new drugs “may release disease awareness communications about the disease a new drug is intended to treat.” Generally, communications about diseases explain the signs and symptoms of the underlying medical disorder, what happens if that disorder isn’t treated, and a recommendation to consumers that consumers should consult with the healthcare provider about what treatments to use.
The information in these general disease communications may not be consistent with the information in advertisements for the drugs that treat the condition. This various/ confusion is called “conflation.” Conflation can cause consumers to have misunderstandings about a drug’s benefits.
“Consumers may mistakenly assume that the drug will address all the potential consequences of the condition mentioned in the ad.” This misunderstanding “may lead consumers to request inappropriate treatment from their healthcare providers.”
The FDA writes that identifying the causes (or contributing factors) of conflation in prescription drug promotion can help reduce consumer confusion and ensure consumers receive the medical care consumers need.
A conflation study by CDER
Researchers at CDER conducted two experiments of adult asthma patients to determine how the similarity of the ads (disease communication awareness and drug promotion), proximity (how close together the ads are shown), and the frequencies of the communications/ads impact a consumer’s understanding and perception of the benefits and dangers risks of a prescription drug.
The participants filled out a questionnaire to assess the results of the study.
Experiment 1
This experiment examined 2,190 patients who, by random assignment, viewed “one of three different types of disease awareness communications.” The communications:
- Varied in the “similarity (e.g., setting, actors, and colors) to an advertisement for a fictitious drug used to treat asthma.”
- The proximity of the communications differed and were selected to “simulate the different ways consumers may view these advertisements within hour-long television programming.” “For example, the two communications could be shown back-to-back or separated by other advertisements or television programming.”
Experiment 2
This experiment involved 1, 621 people involved studying the impact of looking at a disease awareness communication in one day or over several days at least 24 hours apart. This random study involved 12
experimental conditions based on:
- The time delay between exposure to the last disease awareness ad and exposure to the product ad (one day or one week)
- Perceptual similarity of the product ad to the disease awareness ad (similar or distinct)
- The number of exposures to the disease awareness ad (one, three, or six exposures).
The results of the conflation study
Experiment 1
According to Taylor & Francis and according to the FDA analysis, conflation was found in experiment 1, but the degree of similarity and proximity between the communication awareness ad and the drug prescription did not affect the benefit and risk conflation. The more similar the two types of ads were, the FDA wrote that “the more the participants were likely to improperly attribute the drug’s benefits to the treatment or management of the disease.”
Experiment 2
According to Taylor & Francis, in experiment 2, similar rather than distinct ads did affect conflation. Closer proximity also affected conflation. “In addition, asthma knowledge, health literacy, and perceived ad effectiveness increased conflation of benefits in both studies but tended not to modify the impact of similarity or proximity.”
The FDA found that repeat exposures “to the disease awareness communication did not lead to additional conflation of information from that communication with information from the drug advertisement.”
Individual Factors
According to the FDA, better existing asthma knowledge and general health literacy, and the consumer’s perception of the advertisement’s effectiveness – “increased conflation of the drug’s benefits in both studies regardless of the similarity or proximity.”
“Among participants who perceived the drug advertisement as less effective (measured by asking participants questions such as “the commercial was interesting”, “attention-grabbing”, or “relevant”), there was more risk conflation when the two communication types were more similar and viewed in closer proximity to one another.”
Overall conclusions
According to the FDA, there was a low conflation of risks but a high conflation of benefits across all experimental conditions in both studies.
The FDA states that this finding is consistent with prior CDER research and may be due to the “differences in how benefits are usually communicated in the two communications.”
“The benefits of treating a disease featured in a disease awareness communication can be more directly linked to the benefits of a particular drug (e.g., fewer asthma episodes) compared to the risks in disease awareness communications, which communicate the risks of nontreatment. This may make it more difficult to directly link specific drug risks to more general risks of nontreatment.”
The findings demonstrate the potential for disease awareness communications to confuse consumers regarding the benefits and risks of a drug.
The study confirmed prior studies that found that: “Similarity and proximity impact consumer understanding of a drug’s benefits and risks when disease awareness and drug promotion materials are viewed in print or on the web.”
That the conflation results are consistent across different media types (TV, print, and the Internet) helps give pharmaceutical companies the ability to better develop their prescription drug advertising and disease awareness communications. “For example, companies could space out communications and create greater visual distinctiveness between them.”
Asthma was chosen for study because asthma is a common disease – “increasing the likelihood that these results apply to typical prescription drug consumers.”
The FDA states CDER’s research advances CDER’s knowledge about how graphics, format, and disease and product characteristics, affect a consumer’s understanding of the risks and benefits of prescription drugs.
CDER conducted an experiment to help determine if consumers understand the relationship between disease awareness communications and prescription ads. The reason for the study was to determine how much consumers might think that the drugs being advertised are cures or treatments for their diseases when they’re not. The study focused on the similarity of the ads, the proximity of the ads, and the number of exposures to the ads.
Pharmaceutical companies, doctors, and pharmacists who manufacture drugs, prescribe medications, and fill prescription orders should contact Cohen Healthcare Law Group, PC to review their legal and healthcare compliance requirements. Our experienced healthcare lawyers advise drug manufacturers and the medical community about compliance laws and regulations issues.
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