HUMAN PESTICIDE EXPERIMENTS

[Guest guest]

http://tinyurl.com/qswrc

http://www.democrats.reform.house.gov/Documents/20050617123506-

17998.pdf

Reversing a moratorium established by the Clinton Administration, the

Environmental Protection Agency under the Bush Administration is

reviewing or plans to review over 20 studies that intentionally dosed

human subjects with pesticides. The pesticides administered to human

subjects in these experiments include " highly hazardous " poisons,

suspected carcinogens, and suspected neurotoxicants. The studies,

most of which were submitted to EPA by pesticide manufacturers,

appear to routinely violate ethical standards.

The testing of pesticides on humans is controversial. Unlike

pharmaceutical products, pesticides are designed to be toxic. And

unlike pharmaceutical studies, experiments that expose human subjects

to doses of pesticides offer no promise of therapeutic benefit to the

subjects. For these reasons, former EPA Administrator Carol Browner

implemented a moratorium in 1998 on considering or relying upon human

pesticide experiments.

At the urging of pesticide manufacturers, the Bush Administration

reversed this moratorium. Although the Administration's first EPA

Administrator, Christie Todd Whitman, tried at one point to maintain

a moratorium on agency consideration of human pesticide experiments,

this effort was abandoned by the Administration after she resigned

and a court ruling identified procedural defects in her actions.

Under its new permissive policy, EPA has stated that " the Agency is

reviewing … or expects to review " 24 separate human pesticide

experiments as part of its " hazard characterization " process. The

pesticide manufacturers view EPA consideration of these experiments

as central to the industry's efforts to obtain lenient regulatory

standards.

At the request of Senator Barbara Boxer and Representative Henry A.

Waxman, this report evaluates 22 of the 24 human pesticide

experiments submitted to EPA. The report assesses whether the

experiments comply with the ethical and scientific requirements for

research involving human subjects, including the standards in the

Nuremberg Code, the Declaration of Helsinki, the " Common Rule " that

guides medical research in the United States, and a recent report on

human pesticides studies by the National Academy of Sciences. The two

remaining experiments submitted to EPA could not be reviewed in this

report because they were not provided by the agency.

The report finds significant and widespread deficiencies in the 22

human pesticide experiments being reviewed by EPA. In violation of

ethical standards, the experiments appear to have inflicted harm on

human subjects, failed to obtain informed consent, dismissed adverse

outcomes, and lacked scientific validity. The report finds:

HUMAN PESTICIDE EXPERIMENTS

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• Human testing of hazardous substances. The experiments deliberately

exposed human subjects to dangerous pesticides, such as

organophosphates, which were developed in the 1930s for use in nerve

gas, and methyl isothiocyanate, which is closely related to the

chemical that killed thousands in Bhopal, India. In one experiment,

human subjects were placed in a chamber with vapors of chloropicrin,

an active ingredient in tear gas, at levels substantially greater

than the federal exposure limit, causing some subjects to

experience " severe " adverse effects. An older experiment administered

the pesticide carbofuran to human subjects for the explicit objective

of determining " the minimum dose necessary to induce toxic effects

(e.g. headache, nausea, and vomiting). " In many of the experiments,

the subjects were instructed to swallow capsules of toxic pesticides

with orange juice or water at breakfast.

• Serious deficiencies in informed consent. The informed consent

forms used in the experiments do not appear to meet ethical

standards. Some used complex jargon that participants would be

unlikely to understand. Others failed to disclose the potential risks

involved. One experiment exposed subjects to dimethoate, a pesticide

that EPA considers a suspected carcinogen, a developmental toxicant,

and a neurotoxicant. Yet the informed consent form failed to mention

these or any other potential health effects, stating instead that the

chemical is " used to protect or cure all kinds of plants " and

that " not a single health effect is expected. " The informed consent

forms for other experiments repeatedly referred to the pesticide as

a " drug, " potentially giving the test subject the false impression

that the experiment was for a pharmaceutical product. In some of the

experiments, there may not even have been any attempt to obtain

informed consent.

• Unethical liability waivers. The Common Rule governing medical

research provides expressly that " [n]o informed consent … may … waive

or appear to waive any of the subject's legal rights. " Contrary to

this requirement, the informed consent forms used in some experiments

include explicit waivers of liability. For example, the consent form

for the chloropicrin experiment states that the sponsor would not

pay " any … form of compensation if you are injured " other than

medical costs.