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Executive Summary

SQUIBB DISTRIBUTION OF EDITORIAL REPORT COMPARING CAPOTEN v. DIURETIC hydrochlorothiazide for the treatment of hypertension will cease, the firm told FDA in a Nov. 10 letter. "As we agreed, the specific editorial report in question will not be distributed or used in any promotional fashion by Squibb," the firm informed FDA's Division of Drug Advertising and Labeling. The firm was responding to an October letter from FDA in which the agency objected to a "Pharma-View" article touting the ACE inhibitor captopril's (Capoten) superiority over the diuretic hydrochlorothiazide for hypertension therapy. Mailed extensively to pharmacists, the article discussed a Sept. 28, 1989 New England Journal of Medicine report on a study comparing captopril and hydrochlorothiazide. The agency said it believes Squibb sponsored the mailing even though the company's name was not attached to or associated with the article. FDA said it considers the mailing "likely to constitute false and/or misleading labeling on behalf of your firm and to subject Capoten to misbranding" under the FD&C Act. "In this case, the mailing suffers from deficiencies such that it must be considered not reflective of a truly objective examination of the current circumstances," the agency said. FDA noted that "the conclusions of the report go far beyond the investigator's conclusions that ACE inhibitors 'may represent an advantage."' The "Pharma-View" article concludes: "Currently, the majority of patients treated for hypertension in the United States -- indeed throughout the world -- are receiving diuretics. These results suggest that patients should consider asking their physician to be switched to a drug without metabolic side effects. ACE inhibitors, which are efficacious and appear to have no such side effects, are particularly attractive." The article was published by Medical Education Network. FDA stated that "this comment, by a physician evidently not a participant in the study, suggests that (a) diuretics have been demonstrated not to be appropriate for first-line antihypertensive treatment (b) ACE inhibitors are devoid of side effects, and (c) the risk to patients receiving diuretics for treatment of hypertension has been demonstrated to warrant their immediate intervention to effect a change in antihypertensive treatment to ACE inhibitors." The letter adds: "We clearly do not consider such conclusions reasonable at this time." Members of FDA's Division of Drug Advertising and Labeling met with Squibb's regulatory counsel, Thomas Costa, and other company representatives on Oct. 27 to discuss FDA's letter on the "Pharma-View" article. An FDA memo of that meeting notes that Squibb acknowledged that it was responsible for the mailing but "described the mailing as having been independently generated." FDA "made it clear that, as in the case of our recent regulatory actions, independence is not an acceptable defense for funding of activities disseminating false or misleading information."

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