DIRECT-TO-CONSUMER Rx AD COALITION RESEARCH PROJECT WILL INCLUDE IN-HOME STUDY OF TV ADS; STUDIES BY ACADEMIA WILL BEGIN THIS FALL AND TAKE TWO YEARS

The Prescription Drug Advertising Coalition's planned research efforts will include an assessment of the impact of actual TV commercials in the home, CBS Marketing Division Communications Director Donald Evers told the Drug Information Association's annual meeting in Toronto July 13. "An in-home study conducted via cable transmission or video cassette recorders in six to 10 markets will test overall therapeutic classes separately," Evers said. He explained consumers will be shown different versions of actual drug commercials that include "varied levels of risk disclosure . . . and varied levels of warning language." Evers, who is the spokesperson for the coalition, explained further that "the study will measure the impact of the commercials on consumer comprehension/knowledge, belief measures, recall, question-asking behavior, and impressions/evaluations." The study will help to provide "guidance for developing effective television commercial content, [and] maximizing proper information-seeking behavior (such as requesting a medical consultation)," Evers said. The impact of TV advertising is one of several issues to be addressed in a national consumer "survey" project sponsored by the coalition. Other issues include: "undiagnosed patient symptoms"; current "medication knowledge"; whether consumers want more information on Rx drugs, and what kind of communications format is preferred. FDA tested consumer reactions to mock-up TV ads in a survey of its own in 1983-1984. The agency reported that TV ads were more effective than magazine ads at conveying the main message for an imaginary hypertensive patch product. The TV messages also appeared to convey dosage and route of administration information more effectively, FDA found ("The Pink Sheet" May 7, 1984, p. 13). Through an assessment of undiagnosed symptoms, CBS exec Evers said, "some measure" of the usefulness of Rx ads in alerting patients to potential medical problems is possible. In consumer interviews, "a series of symptom clusters would be presented to respondents in an effort to determine the prevalence of specific conditions which are undiagnosed or untreated," he explained. The analysis of "current medication knowledge" will measure "respondent knowledge of possible side-effects, contraindications and substitutes," according to Evers. He added that "interaction with physicians regarding medication will also be examined." Research into consumer interest in prescription drug information will attempt to update current knowledge. Evers noted that the coalition plans to use "other studies as baseline data to provide evidence about whether the perceived need for prescription drug information during the past several years has increased, decreased, or stayed the same." The consumer surveys will be part of a broader research effort under the auspices of one or more academic institutions. That research program is expected to get underway this fall. Evers noted that research proposals currently under review by the coalition are from Georgetown University Medical Center's Institute for Health Policy Studies; Harvard's Division of Health Policy Research and Education; and the University of Michigan's Institute for Social Research/Survey Research Center. Negotiations on the research proposals are apparently under way. The coalition expects to have them completed by the end of the summer "so that research can begin this fall," Evers said. The coalition expects results from the academic projects 18 months to two years after the studies are started. Evers emphasized that once the research contracts are awarded, the academic institutions will proceed on the studies independently. A separate element of the research project will be the development of a series of "white papers," Evers noted. "Following a comprehensive review of the literature to determine how much is already known about each research question agreed to be an important element in establishing the good and bad features of informational drug ads, a white paper will be prepared to document current knowledge." Evers added that other white papers will be commissioned on areas such as "the economic impact which advertising might have on retail drug prices; the Constitution's First Amendment implications of legal drug advertising; and the social impact" of direct to consumer advertising on the public health. Preliminary plans call for a "white paper conference" to review and discuss findings, he noted. After the research program is completed, the coalition will formulate recommendations, Evers said. He portrayed the group as primarily interested in research and not lobbying. Evers maintained that "it is highly likely that unless the results of this research outweigh the recognized risks, the members of the coalition will conclude that only institutional or health campaigns are appropriate for consumer audiences." The research program is the coalition's "primary function," Evers said. Formed in December 1987, the coalition of drug industry and ad representatives has proceeded cautiously and been reticent in discussing its objectives prior to Evers' presentation in Toronto. Evers told DIA that the coalition has cleared its research approach with Capitol Hill. "Following meetings held this spring with congressional staff members and coalition representatives," Evers said, "it was agreed that the coalition research program as outlined is a responsible undertaking which will provide much useful and needed information and data." He added that "there are no promises that such research will somehow end a decade of debate on the issue, but that is certainly the hope of this coalition." As an adjunct to the research project, the coalition also plans to establish an advisory group of "nationally respected experts from the public and private sectors whose health and social policy experience will provide in-depth knowledge and counsel in working with the academic institution selection and funded by the coalition." In addition, Evers said, "a comprehensive list of policy-relevant research questions will be developed after conducting a review of all the literature pertinent to" the issue. The group will also "conduct on-going communication with public policy makers, regulatory agencies, medical and health care organizations and consumer groups" and "conduct extensive testing of commercial formats to determine consumer comprehension and retention of informational and promotional content in advertising." Ultimately, the group expects that its research will allow the determination of "appropriate self-regulation and independent evaluation methods to enforce advertising guidelines and standards to insure highly responsible prescription drug advertising content," Evers said. The coalition is made up of 124 management representatives from 53 organizations, including 13 drug companies, 26 advertising agencies, four TV networks, the three primary national advertising trade associations and five law firms. Founding members include Bristol-Myers, Johnson & Johnson and CBS.