Strengthening and Opening Up Health Research by Sharing Our Raw Data

Use the link above to access the full text of the article from the March 2012 issue of “Circulation: Cardiovascular and Quality Outcomes” published by the American Heart Association. The author notes that the article is “an almost verbatim reproduction” of a talk given at a conference, “Horizon 2020: Investing in the Common Good,” on November 30, 2011. The conference took place at the European Parliament in Brussels, Belgium and “examined what it means to treat knowledge as a public good in policy making and how this should affect future European Union (EU) funding schemes for research and innovation.” The current article begins as follows: ”Public investments in health research give a poor yield because there is too much ownership to the data and secrecy involved. Furthermore, what gets published, if made publicly available at all, is often a highly selective and misleading version of the true results. Although selective reporting violates the Declaration of Helsinki, it is not the exception, but the rule, both for industry-sponsored and academic research. This means that, despite the existence of hundreds of thousands of randomized trials and >4000 updated Cochrane reviews of these trials, physicians and governments cannot choose the best and most cost-effective treatments for the patients. Selective reporting can have disastrous consequences for patients and for our national economies. One example is the rofecoxib (Vioxx) scandal. The drug maker Merck concealed, for many years, that its drug causes heart attacks, and the use of rofecoxib has probably caused ≈10 000 unnecessary deaths in the United States alone... We should no longer accept selective reporting. By sharing all our research data, we could save billions of any currency every year and, at the same time, improve the health and longevity of the citizens and reduce the amount of harm they are exposed to. International calls for sharing the results have come, for example, from the Organization for Economic Co-operation and Development, the World Health Organization, the US Congress, the European Commission, The Cochrane Collaboration, journal editors, and funders. Calls for data sharing have mostly been restricted to publicly funded research, but the distinction between publicly and industry funded research is an artificial and irrelevant one. Respect for trial participants who often run a personal and unknown risk by participating in trials requires that they (and, therefore, the society at large that they represent) be seen as the ultimate owners of trial data. Research can only be a public good, if the public can see the data. It is an unacceptable double standard that trial participants are willing to share data about themselves with the investigators and sponsors when these people are unwilling to share the data with trial participants and others...We must obtain access to the results, the raw data, and the study protocols. Much research could be performed, at almost no cost, on existing data, making it unnecessary to collect new data. Furthermore, the incentive for bias, cheating, and fraud would be reduced when other researchers can check the data. Data sharing would lead to tremendous benefits for patients, progress in science, and much more rational use of healthcare resources based on evidence we can trust... Data sharing would not be anticompetitive for the drug and device industries, because all companies would be affected equally by it. It would lead to competition at a higher ethical level and has potential benefits for drug innovation... The European Commission has recommended that data sharing should mean that the data can be used for whatever purpose other researchers might find relevant, without needing to obtain permission from those who assembled the data... Legislation is needed to make data sharing happen, because guidelines and other voluntary agreements do not work, and there should be appropriate sanctions to hold accountable those who refuse to share their data...”