Postmarketing surveillance study of a non-chlorofluorocarbon inhaler

BMJ 1999;318:810 ( 20 March )

Letters

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler

Such studies initiated by manufacturer are designed to promote product

Postmarketing surveillance studies remain unethical

Authors' reply

Such studies initiated by manufacturer are designed to promote product

The first 150 words of the full text of this article appear below.

EDITOR $---$ The study by Ayres et al may have been selectively designed to promote a product as safe; they endorse it as conformingto unpublished guidelines for postmarketing surveillance studiesunder safety assessment of marketed medicines.¹ Withdrawalsfrom the study are mainly for reasons "not related to safety,"and the withdrawal rate of the product under evaluation is almostthree times that of the salbutamol inhaler with conventionalpropellant.

I have several reservations about the study. Postmarketing surveillance studies initiated by the manufacturer are primarilydesigned to promote a product to the medical profession and thegeneral public. One incentive for patients to enter such a studyis the availability of a prescribed drug without charge. Participatinggeneral practitioners receive a generous fee $---$ particularly attractiveand effective in medical recruitment to this study since "neitherthe patient nor doctor had to undertake any procedures relatedto the study." Criteria . . . [Full text of this article]

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Relevant Article

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines: J G Ayres, C D Frost, W F Holmes, D R R Williams, and S M Ward
BMJ 1998 317: 926-930. [Abstract] [Full Text] [PDF]