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Panel endorses limited toxin testing on humans


An advisory panel yesterday endorsed limited testing of pesticides and pollutants on volunteers - but said the Environmental Protection Agency should accept such studies only when they meet strict scientific and ethical guidelines.

The recommendations of the National Academies' panel of scientists, ethicists and public policy experts drew immediate criticism. Some said anything less than a ban of such tests would open the door to the abuse of research volunteers and weaken public health protections.

"This unhinges the safeguards that were mandated under the Nuremberg Code," said Vera Hassner Sharav, director of the Alliance for Human Research Protection. She referred to guidelines outlined by a World War II tribunal in the wake of Nazi medical experiments.

EPA spokeswoman Cynthia Bergman said the agency was reviewing the report from the National Academies panel and had no response. CropLife America, a pesticide industry trade group, welcomed the report, saying it agrees "with the major finding that human testing is ethical, provided there are safeguards and sound science is used."

James F. Childress, a University of Virginia ethics and medical education professor who co-chaired the National Academies panel, acknowledged that it is controversial to dose volunteers with toxins or pollutants when the subjects don't stand to gain therapeutic benefit.

But the panel concluded that the studies may be acceptable in certain circumstances. It recommended the EPA establish a Human Studies Review Board that would evaluate research plans for scientific and ethical legitimacy before and after they are conducted. This would be in addition to separate groups, known as institutional review boards, selected by sponsors of the experiments to oversee scientific and ethical aspects.

The 15-member National Academies panel also recommended that the EPA consider the results of human tests only when they:

Address an important scientific or policy question that can't be answered with animal tests or by observing people who have been exposed to toxins accidentally, or in the course of their daily lives.

Have potential benefits that outweigh anticipated risks to research participants.

Offer no identifiable risk whatsoever to participants when the tests are aimed solely at persuading the EPA to raise a reference dose (That's the dose used to calculate the amount of food-borne pesticide to which humans can safely be exposed).

The panel said studies aimed solely at raising the reference dose deserve a more stringent standard than other intentional human dosing studies because they provide no public health benefits. It also said its recommendations should apply to all studies that intentionally test toxins or pollutants in people, including air-quality tests sponsored by the EPA and pesticide tests sponsored by chemical companies. The agency has received 19 such studies since 1991.

The EPA suspended use of chemical safety studies in humans in 2001 and asked the National Research Council to convene the panel after criticism that people were being subjected to unnecessary danger.

The Associated Press contributed to this article.

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