YODA and truth seeking in medicine

BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4251 (Published 02 July 2013) Cite this as: BMJ 2013;347:f4251
  1. Peter Doshi, postdoctoral fellow1,
  2. S Swaroop Vedula, postdoctoral fellow2,
  3. Tianjing Li, assistant professor3
  1. 1Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA
  2. 2Johns Hopkins University, Baltimore, MD, USA
  3. 3Center for Clinical Trials, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
  1. pdoshi{at}post.harvard.edu

Making sense of the curious case of rhBMP-2

Last month, Annals of Internal Medicine published a package of articles unveiling the first fruits of the Yale University Open Data Access (YODA) project. At the core of this novel concept is the idea of a coordinating organization—YODA—simultaneously commissioning two independent systematic reviews of patient level data for a medical product, and subsequently offering the data to researchers more broadly.1 2 3 4 5

The YODA project demonstrates one way to redress the problem of incomplete and distorted knowledge by asking industry to put its most detailed clinical trial data in the hands of an independent custodian. The two systematic reviews of data from trials on recombinant human bone morphogenetic protein-2 (rhBMP-2) obtained from Medtronic (Minneapolis, MN) are the first example of applying the YODA concept to seek the truth about the safety and effectiveness of a medical product.

The systematic reviews included trials that compared rhBMP-2 with iliac crest bone grafting, considered the gold standard for spinal fusion surgery. In 2011, a controversy erupted over the safety of rhBMP-2 amid fierce criticism and accusations from the clinical community that Medtronic had understated the product’s known harms.6 This led to an unprecedented collaboration …

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