J&J, Yale enter into an agreement.
Yale University’s Open Data Access Project (YODA) and Johnson & Johnson, the world’s biggest maker of health-care products, have collaborated to release comprehensive clinical drug trial data to academic researchers. This landmark agreement is expected to set a precedent for greater transparency of pharmaceutical companies in the interest of consumers. Joanne Waldstreicher, J&J’s chief medical officer, is confident about the promise of this collaboration.
“We have nothing to hide and if new findings come out – positive or negative – all the better,” she says. Waldstreicher is a former student of Harvard University, where she attended medical school with Harlan Krumholz, a researcher leading the YODA project. Waldstreicher agreed to collaborate with Krumholz on the project after she attended his recent talk on data transparency at an October 2012 conference in Washington.
YODA demonstrated the importance of this quality of research in 2002 when they contested the initial findings from a National Institutes of Health study on Digoxin, a drug used to treat congestive heart failure. In contrast to NIH’s findings that Digoxin was safe for all consumers, YODA’s researchers found the drug to possess particularly harmful side effects for women. The open access project was later set in motion by a collaboration with Medtronic, the largest maker of heart-rhythm devices, when it asked Krumholz’s group to review a trial of Infuse, a product used to treat a degenerative spinal condition.
Johnson & Johnson will initially release information on certain drug trials to YODA, eventually sharing information on medical devices and consumer health products as well. As a result, researchers will be able to further analyze the benefits and side effects of certain products within various consumer groups. Researchers who wish to obtain J&J data need to submit a request to the YODA program, which will be reviewed by a board of advisors. If their request is approved, the researcher will be have access to detailed patient information as part of the data. However, patient privacy is still protected under this agreement.
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