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Executive Summary

Rep. Dingell is planning a September hearing before his House Energy & Commerce/Oversight Subcommittee to discuss FDA efforts to "curtail irresponsible" direct-to-consumer prescription drug ads, the Michigan Democrat told Commissioner Kessler in an Aug. 6 letter. "I look forward to discussing these issues . . . during a subcommittee hearing in September," Dingell said. The congressman said the hearing will review two reports to him by the General Accounting Office on the lack of scientific studies to assess the potential impact of drug ads on consumers, the Congressman added. Dingell publicly released the two reports with the letter on Aug. 9. One report concludes that adequate research does not exist to determine the effects of prescription drug ads on consumers; the other report maintains that surveys on the subject conducted by Scott-Levin Associates are methodologically flawed. The congressman's letter praises Kessler's stated intention "to stem the growth of irresponsible advertising and promotion." Efforts to establish policy and bolster the staff of FDA's Marketing Advertising and Communications Office "should help protect the consumer from the inherent bias in companies' marketing and promotion of their prescription drugs," Dingell said. The Michigan Democrat added that his subcommittee "will be working with FDA in its efforts to curtail irresponsible advertisements and to ensure that drug companies' marketing efforts provide the consumer with fair balance." He suggested that the GAO reports will help the agency counter any industry arguments that scientific data exist to show that consumer ads for prescription drugs are desired, needed or beneficial. "These two studies show the need for competent research to answer the questions regarding the impact of drug advertising on consumer health and on drug prices," Dingell said. "The agency should be wary of, and review carefully, claims regarding the value of direct-to-consumer advertising." A Scott-Levin study last year found that more than 70% of consumers consider prescription drug ads "an important educational tool," "valuable" or "a source of reliable" health care information. It further concluded that physician opposition to consumer-directed ads was waning. When Dingell learned of the study's conclusions, he directed his subcommittee staff "to monitor more closely" industry use of direct-to-consumer advertising ("The Pink Sheet" April 9, 1990, p. 5). Noting that the congressman asked GAO "to conduct a technical review" of five Scott-Levin studies on consumer ads, the GAO report states that the "studies do not permit the valid or generalizable measurement of either physicians' or consumers' opinions about direct to consumer advertising." The market research firm conducted two physician surveys, in 1988 and 1989, and three consumer opinion surveys, in 1986, 1987 and 1989. GAO further contended that "the studies' data do not support conclusions" as to whether acceptance of such advertising is growing and that "the studies' analytical interpretations of the responses are, in many cases, not consistent with conventional analyses of data used in opinion research." Specifically, GAO said findings from the physicians' surveys are of "questionable" validity "because response rates of only 11% or less are far below normal standards for opinion surveys." In addition, the agency said, the surveys' findings "cannot be generalized to the universe" of U.S. physicians because "the percentage of physicians in the U.S. who were included" in the American Medical Association's Master List, from which a random sample was selected, "is not known." GAO further faulted the study for limiting samples "to physicians with office practice" and for providing "no adjustments . . . to ensure that, in the event of low response rates, the sample would adequately represent physicians who were included on AMA's Master List and had an office practice." Regarding the Scott-Levin consumer studies, GAO said the survey sample was selected from a consumer household sample, which was demographically adjusted to be nationally representative of all U.S. consumers. Although "demographically adjusted samples can accurately project purchasing behavior," the agency maintained, "there is no evidence that they can project opinions about direct- to-consumer prescription drug advertising." Consequently, the report states, "there is no way to know whether the opinions that were measured represent those of U.S. consumers generally." Furthermore, Scott-Levin's consumer surveys repeated one basic question, which "is biased in its design." The question was -- "Traditionally, pharmaceutical companies have communicated information about prescription drugs only to health care professionals: Do you think they should also advertise or communicate information about prescription drugs to the general public?" The question is biased because it directs consumers to answer positively in three ways, GAO contended. By alluding to information traditionally provided to physicians, "it implies that such information is important or useful," the agency said. Secondly, the question followed an informational query as to whether the respondent was aware of several recent changes in pharmaceuticals and therefore "emphasizes the changes that were occurring and the need to keep abreast of them." Finally, GAO said, the question links advertising and communication of information, and therefore "captures the respondents who support advertising and those who oppose advertising but nevertheless favor receiving drug information." The GAO report provides Scott-Levin's comments, including the observation that the purpose of the studies "was to measure trends in behavior, as opposed to academic research intended to measure attitudes." According to the report, Scott-Levin also "indicated that the company was not concerned about the lack of national representatives of the samples" because "the company deliberately selected its samples to represent the universe of most likely drug purchasers and prescribers rather than the universe of consumers or physicians." GAO's other report focused on the amount of research that has been conducted on the effects of consumer-directed prescription drug ads. That report found only four studies that attempted to determine whether such promotion has beneficial effects of reducing prices, educating consumers, and getting patients involved in their health care; or has detrimental effects of "physician shopping," increasing costs or inadequate risk information. The report states that the findings from "those few that have examined the possible effects of [consumer-directed prescription drug advertising] have not been shown to apply to all types of advertising or all consumers." The Prescription Drug Advertising Coalition -- a group of advertisers, manufacturers and broadcasters -- proposed in 1989 to study the effects of advertising to consumers through broadcast media. However, the coalition withdrew its proposal after a meeting with FDA in which the agency said it would not relax its advertising regulations to allow airing of prescription drug ads for research purposes. The group had planned to have the study conducted by the University of Michigan's Institute for Social Research.

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