Pharmaceutical Websites and the Communication of Risk Information

Abstract

This study examines the pharmaceutical websites of 44 leading direct-to-consumer (DTC) advertised drugs to determine the extent to which risk information was completely communicated. Three operational definitions of “completeness” were used: communication of the single highest incidence side effect, communication of top three highest incidence side effects, and communication of side effects with incidence of ≥ 10% (all measured in terms of absolute percentage). Results indicated that regardless of the measures used, pharmaceutical websites are unlikely to completely communicate risk information. About two thirds of all sites communicated the single highest incidence side effect or all top three side effects. For drugs with side effects at ≥ 10% incidence, only about half of their websites fully reported all effects at this level of incidence. Implications for advertisers and regulatory agencies are presented.

Notes

¹Direct-to-consumer (DTC) ads contain two types of statements that communicate adverse reactions associated with drug use. First, there is the statement that communicates serious but typically rare adverse reactions. Second, there is the statement that lists common, but not life threatening, side effects displayed by the drug's users. This second statement, labeled the “risk statement,” is the focus of this research.

²These drugs either did not provide any numeric information for adverse reactions, provided numeric information on only selected adverse reactions, or grouped adverse reactions into numeric ranges, for example, “the following events occurred with a frequency > 2%. …”

³The drugs evaluated were Actonel, Adderol XR, Advair, Allegra, Allegra-D, Ambien, Aricept, Boniva, Botox, Ciialis, Concerta, Crestor, Detrol, Ditropan, Elidel, Enbrel, Flonase, Fosamax, Humira, Imitrex, Lamisil, Levitra, Lipitor, Lunesta, Nasonex, Neulasta, Plavix, Premarin, Prempro, Prevacid, Procrit, Relpax, Remicade, Strattera, Topamax, Valtrex, Vesicare, Viagra, Vytorin, Welbutrin, Zelnorm, Zocor, and Zyrtec, Zyrtec-D.

⁴A decision rule was implemented to guide this process in those circumstances where the adverse reaction table/text presented reactions for different dosages of the drug but the different dosage levels were not mentioned in the risk statement. In these cases, the adverse reactions associated with the initial recommended dosage were selected for coding. When the initial recommended dosage could not be located, the lowest dosage was coded.