Clinical Trial Stirs Legal Battles
Science. 1985 Mar 15; 227(4692): 1316-1318.
A lawsuit filed in federal court in Atlanta, Georgia, in February 1982 by two private ophthalmologists and seven prospective patients charges a group of academic physicians with attempting to monopolize radial keratotomy, a surgical procedure for correcting myopia, by labeling it experimental and urging restraint in its use. The parties have agreed to a settlement involving a payment of $250,000 by the defendants and a statement that the procedure is effective in qualified patients and should no longer be considered experimental. A second suit, brought by nine physicians in federal court in Chicago in June 1984, accuses the American Academy of Ophthamology of attempting to control the procedure. The broader issue at stake is how new surgical prdocedures should be evaluated before they are brought into widespread use. In the case of radial kerototomy, a large-scale clinical trial funded by the National Eye Institute is proceeding as planned despite the legal controversy. (KIE abstract)