Extraordinary claims require extraordinary evidence
نویسندگان
چکیده
We thank Light and Warburton (2005) [hereafter LW] for providing a context for us to further discuss and clarify our studies on the cost of new drug development (DiMasi et al., 2003 [hereafter DHG]; DiMasi et al., 1991b [hereafter DHGL]; Hansen, 1979). We disagree, however, with their analyses, comparators, and conclusions. Although LW suggest, through the invocation of selected reported cost figures and other statistics, as well as questions about what may or may not have been included in our analyses, that new drug R&D costs are really substantially lower than are our estimates, their central criticism is that some of the underlying data are proprietary, and they claim, unvalidated. However, they do not address, or even acknowledge, the numerous validations of our results obtained from alternative data sources and analyses that were reported in DHGL (pp. 131–132, 137–140), in US Congress, Office of Technology Assessment (OTA) (1993, pp. 54–67), and in DHG (pp. 176–180). We cross-checked our data against data from a variety of sources, including government healthcare statistics, other investigators’ analyses, data from pharmaceutical firms on drug development activities compiled by third-party vendors for use as business intelligence tools, internal checks against our own long-standing databases of drug development metrics, published industry-level trade association data, and audited company financial statements. The validations vary from checks on the comparability of key characteristics of the investigational compounds of survey and non-survey firms to data collected and reported by others
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تاریخ انتشار 2005