Human Dosing Studies

EPA Embraces Human Testing Without Safeguards
Infamous CHEERS Study Returns and Multiplies Under Different Names

On Friday, April 8, in the midst of Senate hearings on his nomination to head the U.S. Environmental Protection Agency, Stephen Johnson issued a defensively worded statement announcing the cancellation of the CHEERS study in which parents would be paid to spray pesticides in the rooms occupied by their infant children under age 3. Johnson did not admit any ethical problems with the study but nonetheless concluded the study could not go forward due to an atmosphere “of gross misrepresentation and controversy.”

In fact, Johnson is expanding the use of human pesticide dosing studies by EPA. While CHEERS (which stands for Children’s Environmental Exposure Research Study) will not proceed with EPA funding, the same study can take place with private sponsors. In fact, the American Chemistry Council, representing 135 companies including pesticide makers, already pledged $2 million toward the study’s $9 million overall cost.

The reason Stephen Johnson clung so stubbornly to CHEERS is that it serves as a model for industry on how to conduct similar experiments for submissions to EPA. The pesticide industry has been pressing the Bush Administration to liberalize rules on human testing of pesticides and other chemicals since the 1996 Food Quality Protection Act. That Act set ten-fold stricter exposure standards for children absent reliable data showing no harm. Industry needs actual human experimental data to trump animal studies in order to justify relaxed exposure limits.

In February, EPA published a draft policy that opens the door for accepting any experiments conducted by pesticide companies and chemical manufacturers using human subjects without establishing any safeguards to ensure that the studies are conducted ethically and without harm to the subjects. Under this policy, EPA will –

  • Defer adopting protections for infants, neonates, pregnant women, and prisoners that apply to all medical and drug testing overseen by the Department of Health and Human Services. Instead, EPA announces it “may propose to adopt” stricter protections for vulnerable populations at some unspecified future date;
  • Not require companies to demonstrate that they have abided by informed consent, appropriate inducement and other basic ethical standards. Instead, EPA promises “to publish non-binding guidance reflecting its plans” to possibly apply these elemental safeguards sometime in the future; and
  • Avoid any independent safety or ethical review, as is required for other human subject studies. Instead, EPA has assigned one of its own staff members to act as a “Human Subjects Research Review Official.” In practice, however, it is up to the top political appointees to flag unethical corporate experiments on a “case-by-case basis.”

This policy is open for public comment until May 9. Please take a few moments to email a comment to EPA officials and go on record against human testing without safeguards at EPA.

The basic problem is this: human studies to see whether a drug can help its experimental subjects have far more ethical and safety protections than EPA studies to determine whether a chemical harms its subjects. Unless EPA adopts basic safeguards before it accepts human dosing experiments for regulatory purposes, the CHEERS fiasco will replay itself in other studies under other acronyms.