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Executive Summary

CYTOTEC CABLE TV EPISODE REVISED TO ACHIEVE "FAIR BALANCE" after FDA called the dramatic presentations "obvious promotions." The fifth and sixth episodes of Searle's six-part series on NSAID-induced gastric ulcers, "First Do No Harm," were each delayed one week due to revisions made at the request of the agency's Drug Advertising and Labeling Division. The fifth episode aired April 9, and the sixth is scheduled for broadcast on April 16. Division director Ken Feather disclosed that FDA informed Searle on March 30 that the last two installments of the series were unacceptable insofar as the installments lacked fair balance and were "obvious promotions" for Cytotec. Feather was addressing an April 7 conference on company-sponsored medical education in New York City. The revised segments clarify what the approved indications for Cytotec are, the firm said. According to FDA, the earlier version did not distinguish between gastric ulcers and other types of ulcers in discussing Cytotec's ability to prevent gastric ulcers and other serious gastrointestinal damage resulting from chronic nonsteroidal anti-inflammatory drug therapy. Further, the "intern" star of the show made efficacy claims about Cytotec that exceed FDA-approved labeling for the drug, the agency said. FDA reviewed the first four episodes and found the first three acceptable but asked for revisions to part four, which aired March 26. Searle noted that FDA's input on the series was a planned part of the program's development. The six-part weekly miniseries began airing on the Lifetime cable network on March 5. The series represents the first attempt by a drug company to promote a product to doctors through a fictionalized educational program. The "docu-drama" format series focuses on the epidemiology of NSAID-induced ulcers and the problem of having to discontinue NSAID treatment after an ulcer ("The Pink Sheet" March 20, T&G-2).

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