This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.1i
The revision does not ban placebo but allows it only when there is unanimous agreement among members of medical community that no effective treatment is available. In the absence of effective preferred treatment, placebo controlled trials are permissible. In all other cases, its use has been restricted on ethical grounds. Critics have raised objections to the absolutism of the revised version. The basic ethical concern is grounded in one complex question: Are the rights of the subject more important than potential for greater good of the society
If it is felt that inefficacy of drugs can be tested through placebos and new drugs can be developed, should the researchers proceed with the trial or should they be concerned about welfare of the subjects to the extent that they abandon the research This is a question which definitely is not easy to answer. Proponents of the revised version support the declaration that: "In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject."ii
Supporters of placebo controlled trial are of the view that use of an inactive agent is preferable to an active one because it provides an important static reference pointiii. Another major argument in favor of placebo use is connected with Food and Drug Administration in the US that does not approve any drug that has not been tested with placeboiv. While it is true that many resent the imperialistic stance of FDA, the fact remains that in most cases, clinical trials with placebo might appear to be the only option.
It is true that welfare of the subjects is an important concern but equally important is the development of a better and more effective treatment. In case an effective treatment exists and the patient is suffering from a life threatening disease, it is better not to proceed with the placebo control method. But where a slight delay might not significant affect a patient and a clearly effective treatment is unavailable, use of placebo should be allowed unhindered. FDA on one occasion for example "argued that the low risk to subjects justifies the use of placebo arms in clinical trials when effective treatments are available and equipoise is therefore impossible."v
It is possible to reach a consensus on the issue if we study the placebo control method carefully and delineate some clear rules as to when it can be applied. Emanuel, Miller offer a sound solution when they say, "A placebo-controlled trial has a sound scientific rationale if the following criteria are met: there is a high placebo-response rate; the condition is typically characterized by a waxing-and-waning course, frequent spontaneous remissions, or both; and existing therapies are only partly effective or have very serious side effects; or