The Truth about Human Testing
“It’s time for the Bush Administration to realize that children shouldn’t be used as guinea pigs,” says a Natural Resources Defense Council (NRDC) press release last June. Such baseless hype has fueled efforts in Congress to curb the use of human volunteers in studies designed to promote pesticide safety. The result may be fewer effective products on the market to control emerging public health threats.
Both the House and the Senate appropriations language for the Environmental Protection Agency (EPA) proposed outright bans on human volunteer testing research. But the conferees recently drafted a compromise in July that places a moratorium on such studies until after EPA finalizes a rule governing ethical standards for such research.
Unfortunately, the debate is not over. You can expect the anti-chemical activists to continue their crusade against such research by spreading misinformation and pressuring EPA to limit use of studies as part of its upcoming rulemaking.
Yet most scientific bodies support ethical forms of human testing. Two EPA advisory boards jointly concluded in 2000 that human testing can be ethical and valuable when conducted under certain guidelines. And a 2004 National Academy of Sciences study supports ethically conducted human studies because they can improve “the accuracy of the science employed in regulatory decisions” and provide an important “societal benefit.”
Currently, most pesticide science is conducted on rodents. As a recent report by the American Council on Science and Health demonstrates, over-reliance on rodent tests often leads agencies to grossly exaggerate risks to humans. The result is excessive regulation that leads to the removal of useful products from the marketplace without those products going through EPA’s periodic regulatory reviews. Some products never make it to the market, and others languish far too long at EPA.
Anti-chemical activists—including NRDC, Environmental Working Group, and Beyond Pesticides—have pushed for a ban because they know that improved testing may help get more products approved. Indeed, human tests eliminate some of the uncertainties and some of the safety factors associated with extrapolating risks from rodents to humans. Improving scientific testing to allow EPA to adjust such factors will make policy more rational, not less safe. But that matters little to anti-chemical activists, whose only concern is to keep new chemical products off the market.
Consider that for the past seven years of the mosquito-transmitted West Nile fever outbreak, DEET has been the only insect repellant that the Centers for Disease Control and Prevention could comfortably recommend as effective. Researchers dubbed it the gold standard for protection because of its effectiveness and long record of safe use. In contrast, during the past several years, there were well over 16,000 West Nile virus cases and about 650 deaths.
Nonetheless, activist scare campaigns about DEET discourage some people from using it—leaving people at greater risk of catching the West Nile virus. Indeed, who wants to use a product that, according to the Pesticide Action Network, is a potentially dangerous “neurotoxin” that could allegedly affect brain development if they are unaware that such claims are simply hype and that DEET use has never show such effects?
In any case, for those who did not want to use DEET, there is now an alternative—picaridin. Yet during the past West Nile outbreaks, picaridin was still working its way through the EPA approval process, which began in the early 1990s with “pre-registration” meetings. Picaridin was finally approved in 2001, but firms that wanted to incorporate it into consumer products had to gain separate approvals, which means it only recently became available to consumers.
Yet Picaridin would probably not be available today if the pending ban on human studies had been in effect during its approval process. Since the product is designed for use on human skin, testing included the use of volunteers to essentially try out the product to demonstrate its safety.
Currently, ethical codes of conduct are applied to all federally sponsored research. These standards ensure that human studies pose minimal risk to all participants, make certain that all provide informed consent, and demand that the studies undergo review by an institutional review board. According to the National Academy of Sciences, studies that observe these standards pose little risk to study volunteers. The Academy recommended that EPA issue regulations to ensure application of ethical standards for pesticide studies conducted outside government, and EPA has begun by seeking public comment for such standards. Rather than provide thoughtful input, Congress nearly trumped all scientific recommendations by proposing a blanket ban.
It’s a good thing that Congress corrected its error before it was too late. Otherwise, the public might have become the real guinea pigs—subject to the “tests” posed by Mother Nature. But don’t expect the scare campaigns to stop.