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Christopher P. Adams and Van V. Brantner Estimating The Cost Of New Drug Development: Is It Really $802 Million? Health Affairs, March/April 2006; 25(2): 420-428. [Abstract] [Full Text] [Figures Only] [PDF] [Reprints & Permissions]

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Data Source Might Be Subject To Significant Bias

Kevin Outterson   ( 7 March 2006 )

Data Source Might Be Subject To Significant Bias 7 March 2006
Kevin Outterson, Associate Professor of Law West Virginia University Send comment to journal: Re: Data Source Might Be Subject To Significant Bias kevin.outterson{at}mail.wvu.edu Kevin Outterson	Adams and Branter claim that their study "independently verifies" and "replicates" the well-known but criticized studies on drug development costs by Joseph DiMasi and colleagues. The Adams and Branter study actually replicates a potential source of bias, since both the DiMasi and the Adams and Branter studies ultimately rely on data which are self-reported by PhRMA member companies. I read a draft version of this study in February 2005, and I was concerned that the relevent Pharmaprojects/PJB data source was primarily a collection of press releases from pharmaceutical companies. If indeed this is the case, then the underlying data for both studies is unaudited and unverifiable self-reporting from the industry being analyzed. I shared my concerns with Adams in February 2005. He responded that "the data comes from public sources such as press releases and conference presentations and is collected by PJB." A substantially similar statement has been repeated in the present study. The authors go on to say: "Although we have some concern about accuracy, we have no reason to believe that the data are biased." For many years, at least since the publication of Hansen's original study in 1979, the name-brand pharmaceutical companies and their U.S. trade association PhRMA have paid very careful attention to the public expression of their efforts in R&D. Many thoughtful observers might question whether all of the funds which the companies claim are spent on R&D might be more properly allocated to categories such as marketing or promotion. The underlying data are not auditable and are subject to the likely bias of PhRMA companies to maximize reporting of R&D for public relations purposes. This is a huge caveat which should have been clearly discussed in the present study, and certainly undermines any attempt to use this study to establish what the industry needs to spend in order to bring new drugs to market.