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January 22, 1982


JAMA. 1982;247(4):460-461. doi:10.1001/jama.1982.03320290010008

In Reply.—  Unable to corroborate in any major pharmacologic reference book or journal the claim by Drs Silverman and Lewis of "considerable medical success" attributable to phenylpropanolamine-containing diet-aid preparations, I can only marvel at their expression of faith in the safety and effectiveness of the drug. Moreover, the six unpublished doubleblind, placebo-controlled studies submitted by manufacturers and on which the conclusions of the Advisory Review Panel on OTC Miscellaneous Internal Drug Products were based were, by the Panel's own admission, each defective in one or more important facets covered by the panel's proposed protocol.1My implied criticism of the panel was based on a questioning of the rationale for phenylpropanolamine in weight control.2 Unlike Drs Silverman and Lewis—and as a member of an FDA Public Advisory Review Panel myself—I wholeheartedly support public discussion of panel recommendations and constructive criticism by physician and layman alike. Certainly, the pharmaceutical industry