What is the Declaration of Helsinki?
The Declaration of Helsinki was adopted by the World Medical Association in 1964 as “as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.” It has been amended five times, the most recent version being in 2000. [Oddly, enough FDA regulators, noblesse oblige, prefer to use the 1989 version rather than the current 2000 version.] In general the Declaration takes the position that “extreme care must be taken in making use of a placebo-controlled trial” when there is an existing proven therapy. In other words new treatments should be tested against old treatments instead of placebos. This assures that participants in a clinical trial are not denied the benefits of proven treatments. The Declaration does, however, allows for the use of placebos in certain circumstances. Why is there concern over the use of placebos in international trials? In 1997 Peter Lurie and Sidney Wolfe published an article in the New
