Poisoning for Profits

Good news, folks! If you're strapped for cash, there is a quick and easy way to make $460! All you have to do is swallow a pill filled with chlorpyrifos! Sound ridiculous? Not to dozens of college-aged Nebraskans in 1998 after reading a school newspaper ad urging students to "earn extra money." They called the number, signed the seven-page consent form and popped the pill. (By the way - chlorpyrifos, a nerve-gas derivative found to cause brain damage in fetal rats and weakness and vomiting in children, was banned for household use.)

This particular clinical study was commissioned by Dow AgroSciences to vouch for the safety of one of its top-selling bug killers, but they are not alone. After Congress passed the 1996 Food Quality Protection Act (FQPA), which tightened safety standards on thousands of pesticides, chemical companies began scrambling to prove their products safe. They let loose a flurry of small, short-term clinical trials aimed at persuading the Environmental Protection Agency (EPA) to relax the rules that govern exposure to toxic chemicals.

EPA sets an acceptable exposure level for humans by determining the lowest level that is harmful to lab animals and reducing that amount by a series of extrapolating factors. Chemical manufacturers have griped that these standards are largely arbitrary, and began launching a slew of clinical trials to establish more realistic levels.

Pesticide makers have submitted more than a dozen human studies to EPA since 1997, but it has never been established whether it is legally or ethically acceptable to conduct clinical trials that offer no potential benefit to participants, and could actually end up harming individuals in the name of public health. The EPA, in December, 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. EPA assistant administrator Stephen Johnson asked, "Are there clear boundaries between acceptable and unacceptable human research?"

Studies usually only surface when they are submitted to EPA or leaked to the press. There is no system for tracking studies that aren't federally funded and no protocol on how they should be conducted.

For the full story, see: <http://www.time.com/time/covers/1101020422/poisons.html>