ADDRESSING THE PROBLEM OF MISLEADING ADVERTISING

Misleading advertising can significantly undermine physicians' prescribing decisions. The study by Wilkes and colleagues reported in this issue of Annals supports the Food and Drug Administration's (FDA) concerns about the misleading potential of many prescription drug advertisements. The FDA monitors published prescription drug advertisements for misleading information. The FDA's review starts with a comparison of an advertisement with the package insert. However, additional research is frequently necessary to assure the scientific basis for promoted claims. This research often uncovers a lack of substantiation for promoted claims. The FDA has found that misleading comparative drug claims are frequently based on improper statistical inferences that only a critical analysis of the cited clinical studies may unveil. Although the FDA has increased its surveillance, academia, medical practitioners, and the pharmaceutical industry must increase their efforts to ensure that the use of drug products is based on accurate information.