Ethics of Placebo Controlled Trials in MS

Placebo controlled trials are used to test new drugs by comparing the results of those taking the active drug with those taking the inactive placebo. This allows us to know that the beneficial effects, if any, seen in the trial were due to the drug and not to some other aspect of the care surrounding the administration of the drug.

In a disease like MS, where there are several partially effective drugs, it becomes a concern to put someone on a placebo when they could be taking an approved medication. A group of clinicians, ethicists, statisticians, regulators, and representatives from the pharmaceutical industry convened to discuss this topic and published their thoughts.

They concluded that for patients with relapsing MS for which established effective therapies exist, placebo-controlled trials should only be offered with rigorous informed consent if the subjects refuse to use these treatments, have not responded to them, or if these treatments are not available to them for other reasons (e.g., economics).