Pesticide testing on humans: Resnick and Portier respond.In their letter, Needleman et al. suggest that our arguments regarding the ethics of human testing of pesticides (Resnik and Portier 2005) are "vague, tendentious ten·den·tious also ten·den·cious adj. Marked by a strong implicit point of view; partisan: a tendentious account of the recent elections. , and essentially incorrect." However, they offer no effective sustained arguments in support of this conclusion. They cite the Food Quality Protection Act (FQPA FQPA Food Quality Protection Act 1996) and note that this act led pesticide pesticide, biological, physical, or chemical agent used to kill plants or animals that are harmful to people; in practice, the term pesticide is often applied only to chemical agents. companies to sponsor studies in humans, in part, to avoid an additional 10-fold human safety factor. They then chastise chas·tise tr.v. chas·tised, chas·tis·ing, chas·tis·es 1. To punish, as by beating. See Synonyms at punish. 2. To criticize severely; rebuke. 3. Archaic To purify. our article for saying effectively the same thing. Their next point focuses on what they view as a U.S. Environmental Protection Agency Environmental Protection Agency (EPA), independent agency of the U.S. government, with headquarters in Washington, D.C. It was established in 1970 to reduce and control air and water pollution, noise pollution, and radiation and to ensure the safe handling and (EPA EPA eicosapentaenoic acid. EPA abbr. eicosapentaenoic acid EPA, n.pr See acid, eicosapentaenoic. EPA, n. ) failure to enforce the FQPA for organophosphate pesticides organophosphate pesticide A phosphorus-rich organic compound–eg, parathion, that contain a halide which phosphorylates cholinesterase and irreversibly inhibits its activity Management Atropine, pralidoxime , an issue that has no bearing on the ethical question of human testing of pesticides. They claim that we failed to specify exactly how human studies could benefit society, but we clearly stated in our article (Resnik and Portier 2005) that these studies could promote public health by providing knowledge that may be useful in regulating pesticides. It is the responsibility of the party sponsoring or conducting a human testing study to demonstrate the relevance and utility of the proposed study with regard to human toxicity. Needleman et al. contend that we have missed an important issue--the relevance of adult testing to children's risk. This argument is not relevant to our article because we focused on human testing of pesticides on adults, not on children. We seriously doubt whether testing pesticides on children, or on other vulnerable populations, could ever be justified on ethical grounds. It is possible that studies of the effects of pesticides on adults could enhance our understanding of how pesticides affect children, but the party(s) sponsoring the study would need to provide some evidence for this supposition. In our article (Resnik and Pottier 2005) we argued that there may be some cases where the public health benefits of testing pesticides on adults justify imposing risks on human subjects. We did not argue that one of the benefits of testing pesticides on adults is to improve the health of children, but we acknowledge that some studies might have this potential benefit. We addressed arguments concerning the statistical power of human studies in our Supplemental Material, which is available online (http://ehp.niehs.nih.gov/members/ 2005/7720/suppl.pdf). Good statistical design is one of the key principles that must be considered in evaluating the acceptability of human testing, and we acknowledge that some of the disputed pesticide studies have been underpowered. It is surprising to us that Needleman et al. would raise this concern when their key premise is that human testing of pesticides is never ethical. If testing of pesticides is never ethical, then statistical issues, such as sample size, are irrelevant. Needleman et al. have confused the issues relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the FQPA, 10X safety factors, and risk assessment with the questions surrounding human testing of pesticides. We wholeheartedly whole·heart·ed adj. Marked by unconditional commitment, unstinting devotion, or unreserved enthusiasm: wholehearted approval. whole agree that to conduct a clinical study in humans for the sole purpose of keeping a product commercially viable is unethical unethical said of conduct not conforming with professional ethics. . They assume that the only reason why anyone would develop and conduct human studies of pesticides is to promote the interests of pesticide manufacturers. Again, we address this issue in our Supplemental Material (http://ehp.niehs.nih.gov/members/ 2005/7720/suppl.pdf). We argue that a study that benefits private industry can be ethical, provided that it also offers scientific or social benefits. For example, clinical trials of new drugs benefit pharmaceutical companies, but they also benefit patients, enhance our understanding of human disease, and improve public health. The authors declare they have no competing financial interests. REFERENCES FQPA. 1996. Food Quality Protection Act of 1996. Public Law 104-170. Resnick DB, Pottier C. 2005. Pesticide testing on human subjects: weighing benefits and risks. Environ Health Perspect 113: 813-817. David B. Resnik Office of the Scientific Director National Institute of Environmental Health Sciences National Institutes of Health Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS E-mail: resnikd@niehs.nih.gov Christopher Pottier National Toxicology Program National Toxicology Program Environment A program that conducts toxicologic tests on substances frequently found at the EPA's National Priorities List sites, which have the greatest potential for human exposure National Institute of Environmental Health Sciences National Institutes of Health Department of Health and Human Services |
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