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CIBA-GEIGY TIGHTENING INTERNAL CHECKS OF VIDEOTAPED PROMOTIONS

Executive Summary

CIBA-GEIGY TIGHTENING INTERNAL CHECKS OF VIDEOTAPED PROMOTIONS to assure that final versions comply with regulatory requirements, the firm told Senate Labor & Human Resources Committee Chairman Kennedy (D-Mass.) in a Dec. 26 letter. "We have revised our internal procedures so that videotapes are rechecked to ensure that they strictly adhere to the internally reviewed script," Ciba-Geigy Pharmaceuticals Division President Douglas Watson said. Watson's letter responded to questions posed by Kennedy during his Dec. 11-12 hearing on pharmaceutical marketing ("The Pink Sheet" Dec. 17, p. 12). Kennedy asked why Ciba-Geigy distributed a video news release (VNR) promoting nonapproved uses for the gallstone dissolution drug Actigall (ursodiol). "We did not intend to, nor do we, promote Actigall for anything other than its approved indication," Watson maintained. "The fact that the videotapes contained three pieces of improper information was the product of inadvertence rather than design. Unfortunately, the final version of the videotape deviated from the script which had undergone internal review," Watson replied. Ciba-Geigy had received a regulatory letter from FDA objecting to VNR statements that Actigall provides symptomatic relief for gallstone patients and that it cures gallbladder disease. Kennedy also asked why Ciba-Geigy used a celebrity, former New York Yankee baseball player Mickey Mantle, to announce FDA approval of the anti-arthritic Voltaren. The firm, which declined an invitation to send a representative to the hearing to testify, stated that Mantle "was typical of so many arthritis sufferers in that for many years he did not seek a physician's care for his arthritis. However, once under the care of his physician, Mickey was prescribed Voltaren and benefited remarkably." Although "Mr. Mantle was compensated for his time," his comments reflected "his own experiences with the drug," Watson said. "He was not paid, as in advertising, to deliver particular messages that are scripted."
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