The U.S. Food and Drug Administration has turned its back on the rest of the world by proposing that clinical trials done in other countries need not comply with the Declaration of Helsinki, “the stone tablet of medical research ethics,” critics contend.The proposed changes in FDA rules “might lead to studies that are less ethical, so that drugs might be approved for use in the United States on the basis of studies that don’t meet U.S. standards,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group, a non-profit consumer advocacy group based in Washington, D.C.The charge was made in an editorial in the March 26 issue of the journal The Lancet written by Lurie and Dr. Dirceu Greco of the Federal University of Minas Gerais, in Brazil.It was quickly rebutted by Dr. Robert Temple, associate director for medical policy at the FDA’s Center for Drug Evaluation and Research.
