Friday, February 20, 2004

Testing Toxics on Humans Is Ethical, Science Panel Says (washingtonpost.com).

As reported in the Washington Post, a panel of scientists from the National Academy of Sciences issued a report yesterday that says it is ethical to test pesticides and other toxic substances on human subjects to determine whether environmental safety standards can be lowered: "Many scientists and ethicists have argued that such research is never justified, and yesterday's unprecedented verdict by the National Academy of Sciences took environmentalists by surprise."

The ethical analysis is summarized thusly: "While volunteers would derive no benefit and some might incur transient harm, the panel of experts said this would be outweighed by societal benefits. Besides helping regulators set accurate benchmarks for environmental dangers, such trials might also address, for example, how much insecticide can safely be used to fight a malaria outbreak." As politicized and polarized as the debate has been over this kind of testing, the esteemed co-chair of the panel, Jim Childress of the University of Virginia, observed: "While there was no 'foolproof mechanism' to eliminate all risk of patient harm, [the risk for volunteers would generally be] exceedingly low."

What's next? --
Yesterday's decision by a panel of the National Research Council will allow the Environmental Protection Agency to devise a final rule over the next several months, an EPA spokesman said. Both the pesticide industry and environmental groups said they expect the agency will accept the recommendation of the panel, which would also allow the EPA to evaluate human studies of pesticides that had previously been conducted, and give the industry an incentive to conduct new trials.

The panelists called for a rigorous safety and ethics system to evaluate and approve such trials, much like the system used by the Food and Drug Administration to evaluate drug trials conducted by the pharmaceutical industry.

The report allowed for the possibility of trials involving children, but panelists said they could not imagine such tests would ever be conducted. But Erik Olson, senior attorney at the Natural Resources Defense Council, an environmental group, said such tests have already been performed: As recently as 2000, he said, a manufacturer petitioned the EPA to consider data from an Italian study of infants that deliberately exposed them to dichlorvos, an insecticide sold under the brand name Vapona."
The prepublication version of the report can be found on the NAS website. The news release is here.
posted by tommayo, 7:36 AM

Health care law (including public health law, medical ethics, and life sciences), with digressions into constitutional law, poetry, and other things that matter