Experimental Treatment Rules

The Feb. 12 commentary by Dr. Jack Kevorkian on the Food and Drug Administration’s rule to provide patients who are unable to give their consent access to experimental treatments inaccurately represents the intent of our new regulations and unfairly compares them to Nazi experiments conducted on unwilling victims. Kevorkian ignores the emphasis placed in the rule on obtaining informed consent whenever feasible, obtaining the agreement of family members whenever feasible and engaging the community in the research process. The informed consent requirement can be suspended only in life-threatening situations, such as heart attacks, strokes or serious head injuries, that cannot be treated through conventional means but might benefit from a promising experimental intervention.

The research must be scientifically and medically rigorous and approved by the FDA. A mandatory data safety and monitoring board will stop any study if there is evidence that the experimental treatment is worse than conventional therapy. An Institutional Review Board and an independent physician must find that obtaining informed consent is not feasible.

The FDA rule requires additional special protections through prior public disclosure of the study and its risks and benefits, consultation with the community from which patients will be drawn and public disclosure of the study’s results.

The easy way out is to let people in a life-threatening situation die, or even help them end their lives. Infinitely harder is to find ways to bring them back to a productive life. This rule is designed to allow the research process in this limited area to proceed in a controlled and ethical manner.

MARY K. PENDERGAST

Deputy Commissioner

Public Health Service, FDA

Rockville, Md.