Gag Clauses in Clinical-Trial Agreements

Abstract

Gag clauses in clinical-trial agreements prevent investigators from examining the data independently or submitting a manuscript for publication without first obtaining the consent of the sponsor. Sponsors with a financial interest in the outcome of clinical research can suppress negative results. They can also interfere with the publication of unfavorable data on safety, as it was recently alleged that Merck officials did in the company-sponsored “Advantage” study of rofecoxib for the treatment of osteoarthritis published in 2003.¹ Some of the hidden data, like those related to cyclooxygenase-2 inhibitors and the use of antidepressants in children, may eventually become public, but . . .