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Executive Summary

SEARLE RUNNING REMEDIAL CYTOTEC AD in April and May issues of 30 medical journals, under an agreement with FDA. The ad is designed to correct a previous Cytotec ad that FDA believes implies that the anti-ulcer drug may be taken by all users of nonsteroidal anti-inflammatory drugs. The two-page remedial ad begins with the bold-type statement: "Published to correct a previous advertisement which [FDA] considered misleading." Underneath this, a color picture of the "misleading" ad is shown. The remedial ad goes on to say that FDA "has requested that we bring to your attention a recent advertisement for Cytotec (misoprostol) which may have suggested that Cytotec should be administered concomitantly to all patients taking nonsteroidal anti-inflammatory drugs (NSAIDs)." The correction adds: "We regret that this advertisement might have been interpreted in that manner." Searle subsequently cancelled future appearances of the original ad. In a boxed section, the ad points out that Cytotec "is indicated for the prevention of NSAID-induced gastric ulcer in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, [and] at high risk of developing gastric ulceration, such as patients with a history of ulcer." Searle agreed to run the remedial ad in two consecutive issues of the same medical journals that ran the original advertisement, including: Journal of the American Medical Association, New England Journal of Medicine, The Lancet and Gastroenterology. The original three-page ad, which includes a brief summary, ran mostly in January issues of the journals. The ad consisted of a picture of a woman opening a door and a caption that reads: "Thanks to NSAIDs, she can open a door." The adjoining page says: "Thanks to Cytotec, she can take her NSAIDs." Below that the ad states: "The only proven protective co-therapy for patients on NSAIDs -- Cytotec." A Feb. 20 letter from Office of Drug Standards Director Peter Rheinstein to Searle President Sheldon Gilgore details FDA's objections to Cytotec promotions and agreements between the agency and Searle regarding promotions that were reached in a Jan. 22 meeting. In the letter, Rheinstein stated: "Your firm has repeatedly promoted Cytotec beyond [its] approved indication." The FDAer refers to the "Thanks to NSAIDs" ad as "the most recent example of such promotional practices by your firm." Rheinstein pointed out that "the ad does not indicate or suggest that the woman suffers from any medical condition resulting in her being at risk of complications from a gastric ulcer. Instead, she could be readily described as a typical NSAID patient." He added: "This advertisement clearly promotes Cytotec for 'co-therapy for patients on NSAIDs,' rather than as a drug to be administered to a very select population that is at risk." The FDAer noted that similar ads appearing in the 1990 issue of Specialist's Pocket Reference and promotional labeling pieces "also promote Cytotec as 'co-therapy' without defining the population to receive Cytotec in a meaningful way."

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