National Academy of Sciences Human Testing Study Grossly Inadequate, Says NRDC

Group says Study is Contradictory: It Calls for Stricter Controls on Testing Toxic Chemicals on Human Subjects, Yet Okays Such Experiments on Children

WASHINGTON (February 19, 2004) - A National Academy of Sciences report released today on human testing of toxic chemicals is "gravely disturbing," according to NRDC (the Natural Resources Defense Council). The group found that the report vaguely urges researchers to adhere to the highest ethical and scientific standards, but then creates exceptions to the rule, even going so far as to recommend that the Environmental Protection Agency adopt rules allowing the chemical industry to test toxic chemicals on children. Additionally, the report recommends that EPA accept old studies of questionable ethical validity, and allow industry to conduct human experiments that have no public health or environmental benefit.

NRDC questioned many of the report's recommendations, noting that several of them directly contradict those made by a previous panel of scientists convened by EPA's Scientific Advisory Panel and Science Advisory Board in 2000.

"The Academy report calls for the highest ethical and scientific standards, but undermines its own recommendations by making the appalling suggestion that it is okay to experiment with toxins on kids," said Erik D. Olson, an NRDC senior attorney. "The report also shockingly says that federal agencies should accept the results of old, ethically questionable experiments with toxic chemicals on people unless there is 'clear and convincing evidence' that they were intended to hurt people or were otherwise absurdly unethical. We thought that these issues were resolved 50 years ago after the Nuremberg trials, but the chemical industry continues its campaign to make it acceptable to use human guinea pigs to maximize their profits. Shame on them."

NRDC maintains that no human tests of pesticides are ethically or scientifically acceptable. At a minimum, Congress and EPA should impose a moratorium on accepting results from industry human tests, at least until all of the minimal protections recommended by the Academy are in place. NRDC said that in light of its close ties to corporate contributors, it is questionable whether the Bush administration can be trusted to swiftly adopt such protections to stem the likely tide of new chemical industry tests prompted by today's Academy report.

The Academy report was written by a committee that included scientists with close ties to the chemical industry. It was co-chaired by a former pesticide industry executive and lawyer, Michael Taylor, and included at least three chemical industry consultants, including James Bruckner, who is a highly paid consultant to Lockheed-Martin in ongoing litigation in which the company contends that rocket fuel-contaminated tap water is harmless, based upon a human study it funded.

The report's inconsistencies are troubling, said Olson. For example, it appropriately calls for the highest ethical and scientific standards for human tests on the one hand (pp. 1-3), but then suggests elsewhere that many of these standards could be discretionary or "not inflexible" (pp. 10, 12), and not applied to industry tests that already have been completed unless there is "clear and convincing evidence" that they were "intended to seriously harm" the subjects or "failed to obtain informed consent" using a flexible definition of that term (p. 16).

It also recommends on the one hand that human studies should only be allowed if there is a "compelling scientific need" to answer questions that "cannot be answered with animal studies or non-dosing human studies" (p. 4), but later says that chemical industry studies intended to weaken health standards, with no human health or environmental benefit, should be allowed in some cases (p.7). Further, it urges that studies used to improve the accuracy of standards pose a "reasonable certainty of no harm" (p.7), but then urges that a compensation scheme be adopted to provide free medical care for human subjects who have been harmed by industry experiments (p. 10). Finally, it recommends a new EPA ethical and scientific review board to review all human studies before and after they are completed (pp. 11-12), but then says that past studies that were not reviewed by EPA beforehand could be accepted (pp. 14-16).

"We're profoundly troubled and confused by the Academy's report," Olson said. "It's like getting a D essay from your star student."