To clarify comments from Goozner and the Center for Science in the Public Interest (CSPI), I would like to provide the pertinent facts on my compliance with EHP’s policy on competing financial interest disclosure.
First, I was on loan or “seconded” from Procter & Gamble (P&G) to the Organisation for Economic Co-operation and Development (OECD) in Paris. The secondment was arranged at the request of the OECD, and I was officially under contract and employed by them from October 2002 through October 2003. I offer the former manager of the department, Herman Köeter; the current manager, Andrew Wagner; and their manager, Robert Visser, as references for these points.
Second, in this approximate period, I was a corresponding or contributing author on 11 relevant publications on assays that were either undergoing formal validation at the OECD or were being developed along similar lines for endocrine mechanisms (Ashby et al. 2002a, 2002b, 2003, 2004; Fang et al. 2003; Kanno et al. 2001, 2003a, 2003b; Owens and Ashby 2002; Owens and Köeter 2003; Owens et al. 2003; Yamasaki et al. 2003). In all cases but one, my P&G address was used.
Third, the one exception involved the article questioned by Goozner (Yamasaki et al. 2003). Kanji Yamasaki of the Chemical Evaluation and Research Institute in Japan was the corresponding author in this case. Because work on this manuscript (Yamasaki et al. 2003) occurred while I was at the OECD, Yamasaki used the OECD affiliation when submitting the manuscript to EHP. I simply did not notice the affiliation. If I had, I would have changed it to use my P&G affiliation to be consistent with the other 10 publications during this period.
Last, neither I nor P&G have any financial interest in the publications or their subject matter. Rather, this work was done to progress both development and validation work on safety tests that have potential for use to serve a diverse range of parties, including regulators, industry, and the public. Therefore, I do not see how allegations of a competing financial interest are valid in this case, even considering the oversight on the affiliation.
I hope this fully clarifies the record on this matter and lays the CSPI allegations to rest.
References
- Ashby J, Lefevre PA, Tinwell H, Odum J, Owens W. Testosterone-stimulated weanling rats as a replacement for castrated rats in the Hershberger anti-androgen assay. Regul Toxicol Pharmacol. 2004;39:229–238. doi: 10.1016/j.yrtph.2004.02.001. [DOI] [PubMed] [Google Scholar]
- Ashby J, Owens W, Deghenghi R, Odum J. Concept evaluation: an assay for receptor-mediated and biochemical antiestrogens using pubertal rats. Regul Toxicol Pharmacol. 2002a;35:393–397. doi: 10.1006/rtph.2002.1557. [DOI] [PubMed] [Google Scholar]
- Ashby J, Owens W, Lefevre PA. Concept evaluation: androgen-stimulated immature intact male rats as an assay for antiandrogens. Regul Toxicol Pharmacol. 2002b;35:280–285. doi: 10.1006/rtph.2002.1543. [DOI] [PubMed] [Google Scholar]
- Ashby J, Owens W, Odum J, Tinwell H. The intact immature rodent uterotrophic bioassay: possible effects on assay sensitivity of vomeronasal signals from male rodents and strain differences. Environ Health Perspect. 2003;111:1568–1570. doi: 10.1289/ehp.5981. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Fang H, Tong W, Branham W, Hong H, Xie Q, Moland CL, et al. Structure-activity relationships of 202 natural, synthetic and environmental chemicals for binding to the androgen receptor. Chem Res Toxicol. 2003;16:1338–1358. doi: 10.1021/tx030011g. [DOI] [PubMed] [Google Scholar]
- Kanno J, Onyon L, Haseman J, Fenner-Crisp P, Ashby J, Owens W. The OECD program to validate the rat uterotrophic bioassay to screen compounds for in vivo estrogenic responses: Phase 1. Environ Health Perspect. 2001;109:785–794. doi: 10.1289/ehp.01109785. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Kanno J, Onyon L, Peddada S, Ashby J, Jacob E, Owens W. The OECD program to validate the rat uterotrophic bioassay. Phase 2: coded single dose studies. Environ Health Perspect. 2003;111:1550–1558. doi: 10.1289/ehp.5870. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Kanno J, Onyon L, Peddada S, Ashby J, Jacob E, Owens W. The OECD program to validate the rat uterotrophic bioassay. Phase 2: dose–response studies. Environ Health Perspect. 2003;111:1530–1549. doi: 10.1289/ehp.5780. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Owens JW, Ashby J. Critical review and evaluation of the uterotrophic bioassay for the identification of possible estrogen agonists and antagonists: in support of the validation of the OECD uterotrophic protocols for the laboratory rodent. CRC Crit Rev Toxicol. 2002;32:445–520. doi: 10.1080/20024091064291. [DOI] [PubMed] [Google Scholar]
- Owens W, Koëter HBMW. The OECD special program to validate the rat uterotrophic bioassay: an overview. Environ Health Perspect. 2003;111:1527–1529. doi: 10.1289/ehp.6413. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Owens W, Ashby J, Odum J, Onyon L. The OECD program to validate the rat uterotrophic bioassay. Phase 2: dietary phytoestrogen analyses. Environ Health Perspect. 2003;111:1559–1567. doi: 10.1289/ehp.5949. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Yamasaki K, Sawaki M, Ohta R, Okuda H, Katayama S, Yamada T, et al. OECD validation of the Hershberger assay in Japan: phase 2 dose response of methyltestosterone, vinclozolin, and p,p’-DDE. Environ Health Perspect. 2003;111:1912–1919. doi: 10.1289/ehp.6357. [DOI] [PMC free article] [PubMed] [Google Scholar]