September 1980

Drug Advertising-Reply

Author Affiliations

Group Vice-President AMA Scientific Publications 535 N Dearborn St Chicago, IL 60610

Am J Dis Child. 1980;134(9):902. doi:10.1001/archpedi.1980.02130210078027

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In Reply.—Mr Barna is not correct in stating that Actifed-C and Tuss-Ornade were found by committees of the National Academy of Sciences to be ineffective for any indication. If this had been so, then these drugs would have been withdrawn from the market by the Food and Drug Administration (FDA). The judgment made was that the effectiveness of these drugs was not proved by clinical trials conducted by experts. The companies that market these drugs have been permitted by the FDA to continue to market them for a limited period of time or until their effectiveness has been proved by controlled clinical trials. The advertisements for these drugs carries the notice that there is lack of substantial evidence for the effect purported, but this does not prove that they are ineffective. The AMA Council on Drugs adopted a position in the early 1970s that "drug combinations are irrational." Such