Analysis of Private-Sector Supported Research

Animal models are used throughout discovery, development, preclinical testing, and production phases of new medicines and vaccines. Pharmaceutical and biotechnology companies use animals in the research and development of candidate compounds. In addition, regulatory agencies require that all new prescription drugs and biologics be subjected to thorough efficacy and safety testing prior to licensing. These requirements are in place to not only prevent potentially dangerous products from reaching human clinical trials and eventually the market, but also to ensure that only effective medications reach patients. In this context, many pharmaceutical companies state that NHPs are used when no other acceptable alternative exists and that the usual goal of using NHPs is to evaluate efficacy and safety as a final step prior to testing in humans. Several pharmaceutical companies no longer use chimpanzees, including GlaxoSmithKline, which has an official published policy indicating it has voluntarily ended the use of great apes, including chimpanzees, in research and will no longer initiate or fund studies (GlaxoSmithKline, 2011).

Committee analysis of the use of chimpanzees in the private sector was hindered by the proprietary nature of the information. However, based on limited publications and public non-proprietary information, it is clear that the private sector is accessing both the whole-animal model as well as stored biological samples (Carroll et al., 2009; Olsen et al., 2011). In addition, from data provided by the four NCRR-supported centers, the committee learned that from 2006 to 2010, 144 chimpanzees were used for efficacy, safety, and pharmacokinetic (PK) studies, suggesting that chimpanzees have been a part of the process of drug and/or vaccine development. These data do not make clear, however, which of these studies were funded by private companies and which, if any, were funded by the federal government. In addition, between 2005 and 2010, more than 300 requests for biological samples have come from individuals or groups with private funding, but, again, it was not possible to determine what percentage was funded by industry (Abee, 2011b; Langford, 2011; Rowell, 2011).

Use of chimpanzees in the United States is not limited to U.S.-based investigators, agencies, or companies. Between 2005 and 2010, 27 studies were funded by either non-U.S.-based companies or non-U.S.-based academic investigators (Watson, 2011). The majority of these studies were for hepatitis C therapy or vaccine development, with a few additional



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