Ever been so strapped for cash that you'd swallow pesticide for $460? That's what dozens of college-age Nebraskans did in 1998 after reading a school-newspaper ad urging students to "earn extra money." They called 402-474-PAYS, signed a seven-page consent form and popped a pill loaded with the active ingredient in Raid roach spray. Dow AgroSciences commissioned the trial to vouch for the safety of one of its top-selling bug killers, chlorpyrifos.
Clearly, clinical trials are not just for doctors anymore. Chemical companies like Dow got into the business after Congress passed the 1996 Food Quality Protection Act, which tightened safety standards on thousands of pesticides. The manufacturers responded by unleashing a flurry of small, short-term clinical trials aimed at persuading the Environmental Protection Agency to relax the rules that govern exposure to toxic chemicals.
At issue is the roundabout way that the EPA assesses human risk. Basically, it sets acceptable exposure levels for humans by determining the lowest level that is harmful to lab animals and then reducing that amount by a series of extrapolating factors. Chemical manufacturers have complained loudly that these standards are largely arbitrary. It was in order to establish more realistic levels that they began launching a slew of clinical trials.
Since 1997 pesticide makers have submitted more than a dozen human studies to the EPA. What has never been established, however, is whether it is acceptable--legally or ethically--to conduct clinical trials that offer no potential benefit to participants (other than monetary gain) and could end up harming individuals in the name of public health. In December the EPA declared a moratorium on the use of such data and asked the National Academy of Sciences to tell the agency whether it should accept research that deliberately exposes people to toxic substances. "Are there clear boundaries between acceptable and unacceptable human research?" asked EPA assistant administrator Stephen Johnson. The academy is mulling over the question.
Meanwhile, chemical companies could still be quietly conducting human trials. "There's no telling because there's no system for tracking studies that aren't federally funded," says Ken Cook, president of the Environmental Working Group, which opposes the pesticide tests. "There's no protocol on how they should be conducted. We're talking about the wild, wild West here."
The studies usually surface only when they are submitted to the EPA--or when they are leaked to the press. A year and a half ago, newspapers in California reported that researchers there were paying healthy volunteers $1,000 to complete a six-month regimen of perchlorate, a rocket-fuel component that disrupts thyroid function and may cause retardation in babies. Lockheed Martin funded the study after some 800 lawsuits charged that the company leaked perchlorate into the water supply and made people sick.
And what ever came of Dow's experiments on chlorpyrifos, the killer ingredient used in Raid and hundreds of other bug sprays and lawn-care products? The EPA ended up banning household use of the insecticide, a nerve-gas derivative found to cause brain damage in fetal rats and weakness and vomiting in children. --By Julie Rawe