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and Scientific Flaws Found in Pesticide Testing on Humans
(Beyond Pesticides, November 9, 2004) Newly published research found scientific and ethical deficiencies in human pesticide-dosing studies submitted to EPA for consideration during the pesticide registration process. The author, Alan Lockwood MD, sought to understand human testing issues by obtaining six studies from EPA under the Freedom of Information Act that involved human test subjects. His research, "Human Testing of Pesticides: Ethical and Scientific Considerations," was published in the November 2004 edition of American Journal of Public Health.
Each of the studies claimed to use an ethical standard called the Declaration of Helsinki. The author evaluated each report for compliance with this standard. The research found inadequate compliance in the following areas:
- unacceptable informed consent procedures
- unmanaged financial conflicts of interest
- inadequate statistical power
- inappropriate test methods and endpoints
- distorted results
The declaration states that “research…must…improve diagnostic, therapeutic and prophylactic procedures and the understanding of …disease” and “the interests of science and society should never take precedence over the…well-being of the subject.” As none of the studies appeared in scientific literature, it seems that the studies were not meant for improved general scientific knowledge and understanding.
In addition, ‘informed consent’ was found to be lacking. One study reviewed referred to aldicarb, the pesticide administered to humans, only as “the compound under test,” even though the consent form states “I have been given a full explanation of …any reasonably foreseeable untoward effects.” In the study regarding azinphos methyl, participants were only given a partial list of possible side effects, with the symptoms of weakness, respiratory failure and death being excluded. In addition, should the participant decide to back out of the study at any time, they may not receive payment.
The author also found each study to be ‘underpowered.’ This means that so few test subjects were involved that the results are inconclusive and the whole testing group was exposed to risk unnecessarily.
There has been a recent uproar, including from certain staff of EPA itself, due to EPA’s new proposed study Children’s Environmental Exposure Research Study, to test pesticides on children.
Dr. Lockwood states in his paper, “Given today’s knowledge of the effects of pesticides, there is no assurance that any such study can be completely free of short-term risks, long-term risks, or both.” He called for an EPA committee free from political and financial conflicts of interest to review the practice of human testing.