Despite the clear implications of clinical equipoise
for the ethics of placebo-controlled trials, numerous trials, such as the hypericum-sertraline trial, continued to use placebo controls despite proven effective treatment.
Miller and Brody's attack on clinical equipoise
comes at a time of increasing skepticism in the general population about the motives of researchers and research sponsors as well as the ability of governments to protect participants.
DeMarco and Markman reject our critique of clinical equipoise
on two grounds.
(3.) Miller and Brody, "Against Clinical Equipoise
His argument depends on clinical equipoise
and amounts to asserting that there is no difference between research and treatment in these trials.
Grady, "What Makes Clinical Research Ethical?" Journal of the American Medical Association 283 (2000): 2701-2711; Miller and Rosenstein, "The Therapeutic Orientation to Clinical Trials"; Miller and Brody, "A Critique of Clinical Equipoise
One counterproductive consequence of this situation would be a reluctance to perform or refer patients to clinical trials (this "crisis of confidence" is partly what motivated Freedman's original articulation of clinical equipoise
7D (See exceptions (b) and (c) under article 7.4: "Clinical equipoise
is widely regarded as the moral foundation of the randomized-controlled trial.
The literature does not, however, address CRTs of the kind we envision, in which the agents being compared are standard treatments that stand in clinical equipoise
In many ways this case study revisits issues that arose when the concept of clinical equipoise
was first being developed.
Such use may be appropriate when a new or currently used intervention is in clinical equipoise
with no intervention or a placebo, and when no clearly effective therapy is available for the study population.
As Joffe and Miller point out in "Bench to Bedside: Mapping the Moral Terrain of Clinical Research," much of the traditional thinking about investigators' ethical obligations, from Freedman's seminal paper on clinical equipoise
and on, assumes that research ethics is just another genre of clinical practice ethics.