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MARION CARAFATE PROMOTIONAL COMPARISONS TO CIMETIDINE

Executive Summary

MARION CARAFATE PROMOTIONAL COMPARISONS TO CIMETIDINE were discontinued as of Oct. 1, pending FDA review of data supporting the claim, Marion's law firm, Kleinfeld, Kaplan, and Becker, said in an Aug. 3 memo to the agency. Marion recently agreed to temporarily discontinue making the comparative claim for Carafate (sucralfate) over SmithKline's Tagamet (cimetidine) in promotional pieces discussing ulcer healing rates in patients that smoke. FDA objected to the comparative claim, as well as a number of other claims, for Carafate in correspondence that was initiated in May. The promotional piece, contained in a detailing package called the Detail Keeper Visual, states: "Carafate achieved significantly better ulcer healing than cimetidine (p<0.05) at four weeks in patients who continued to smoke, during a comparative study of 283 patients with duodenal ulcer." FDA objects to the claim because it is based on a study at Lam et. al., in which cimetidine was given at a dose of 200 mg t.i.d. and 400 mg h.s. "We do not consider studies employing cimetidine administered in regimens other than 800 mg h.s. to be an appropriate basis for comparative promotional claims relative to Carafate," FDA told Marion in a May 12 letter. Marion presented revised smoker promotions to FDA at a July 29 meeting and indicated to the agency that it would pursue the comparative claim with FDA's Division of Gastrointenstinal & Coagulation Drugs Director Stephen Fredd, MD. According to the Aug. 3 memo of the meeting, Marion said it "would not make the comparative claim until this issue was resolved scientifically." FDA also objected to an ad in the promotional package discussing use in patients taking nonsteroidal anti-inflammatory drugs (NSAID). The agency objected to the statements "when NSAIDS puncture the mucosal armor" and "Carafate offers a local healing approach to a local problem, allowing patients to continue their NSAID therapy." FDA considers the statements to be a claim of Carafate's efficacy in the treatment of NSAID-related duodenal ulcers, the agency said in the May 12 letter. "We are not aware of any evidence that Carafate is effective when administered under these circumstances," the letter states. Marion agreed "to clarify future claims to limit them to treatment of NSAID-related ulcers when NSAIDS are discontinued," according to an FDA memo of a July 18 meeting with the company. The memo noted that after the meeting FDAers discussed that "Carafate is indicated only for duodenal ulcers and most NSAID-related ulcers occur in the stomach, not the duodenum. Therefore, the firm should make this distinction in any NSAID-related promotional claims." Marion's overall theme in its promotion is that "ulcer-prone patients need non-systemic Carafate," specifically, those taking NSAIDS, who smoke, are over 55 years old, or are hospitalized. FDA's objections to Carafate promotions follow agency action against SmithKline ads for Tagamet and Glaxo ads for Zantac. SmithKline received a regulatory letter in June for promoting Tagamet for unapproved indications, including NSAID-related GI damage ("The Pink Sheet" Aug. 29, p. 7). Glaxo ads were the subject of FDA attention in February 1985 and September 1985. The extended promootional claims for the products may be indicative of the growing competitiveness in the ulcer market. Much of the growth in the ulcer are is being taken by new entries like Merck's Pepcid and Lilly's Axid.
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