From promises to policies: is big pharma delivering on transparency?BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g1615 (Published 26 February 2014) Cite this as: BMJ 2014;348:g1615
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Peter Doshi has provided a very nice summary of the data sharing activities by the pharma industry. He mentions the Yale Open Data Access (YODA) Project and our recently announced project with Johnson and Johnson. In the article he lumps this effort with several others, but we believe it is distinctive as it represents the first time that a company has transferred full authority over the release of the clinical trial assets that it controls to an independent, academic partner. Those seeking to use the data will go through YODA rather than the company. This transfer of authority is truly distinctive in our view. YODA will work with stakeholders to develop a data release process that best serves the interests of society by promoting the best science and minimizing the likelihood that any unintended adverse consequences will accrue.
Competing interests: I have received funding by Medtronic and Johnson and Johnson to share clinical trial data.
Peter Doshi's report (BMJ 2014;348:g1615) provides important clues about how transparent must be "transparency" to satisfy the intersubjectivity criterion of empirical science. My reading of his report indicates that only FDA's Thomas Marciniak, who worked with the raw data in the case of the RECORD rosiglitazone study, meets the criterion. All the other data-sharing arrangements described fail to meet the criterion.
Curious and disturbing is the reported posture of the FDA that data release is “not a central focus of core regulatory mission . . . We encourage independently organized efforts to create, curate and share clinical trial datasets from all sources.” (1) The FDA has all the data from all trials from all pharmaceutical companies that sought and received marketing approval for their products. One would think that probing the bona fides and quality of the data on which it purportedly makes decisions would be at the heart of the FDA mission.
For this reason I conclude that the most cost-effective way to proceed would be for the U.S. Congress to mandate that the FDA own its responsibility and take leadership in sharing the raw data of clinical trials for reanalysis by technically competent independent parties. In this way years of foreseeable arguing about the meaning of "transparency" and gaming by the self-interested pharmaceutical companies can be forestalled.
(1) Moscicki R. Responsible sharing of clinical trial data: an FDA perspective. 2014. www.cbinet.com/sites/default/files/files/Moscicki_Richard_pres.pdf
Competing interests: No competing interests