Testing pesticides in humans: of mice and men divided by ten.

IMAGINE THAT A RELATIVE OR A FRIEND ASKED YOUR OPINion about accepting $1000 to participate as a human subject in an experimental trial in which he would be required to consume a pesticide. Were you aware that such experiments were permissible? What advice would you give? Breaking with a long tradition in the ethics of human experimentation that distinguished therapeutic from nontherapeutic agents, the Environmental Protection Agency (EPA) published a final rule in February 2006 on ethical guidelines for enrolling human participants in testing pesticides. Data from such experiments are used to reduce the economic costs in the statutory obligation for companies to protect the food supply from dangerous levels of pesticide residues. The policy gives regulatory standing to experiments that intentionally expose adults to toxic pesticides and could set a precedent for similar experiments involving other industrial chemicals. In addition, the policy opens the door for enrolling children, pregnant women, prisoners, and others in observational studies involving pesticides. It also raises ethical questions about how testing will be conducted in developing countries. This Commentary reviews the historical path leading to this policy, discusses the ethical codes that call the policy into question, and summarizes the ethical grounds to reinstate the longestablished distinction between therapeutic and nontherapeutic agents in human dosing experiments.