Labeling Studies with a Reliability Factor?

17 December 2009

Unreliable knowledge production pays off, as we can conclude from the billions of dollars spent oseltamivir (Tamiflu), without convincing evidence. Studies on oseltamivir are considered less reliable due to commercial sources of research, a lack of transparency of data and the absence of external scrutiny and review (doi:10.1136/bmj.b5405).

Therefore, a plea for more reliable data on oseltamivir, and more transparency on raw data seems very straightforward. However, the ethical question arises: Can we still legitimize commercially funded research? Patients given treatment based on less reliable studies are put at risks. And what to think of the balance between risks, burdens and benefits for trial participants, when possible benefits are questionable? Increased scrutiny and external control would be logical policies to suggest. However, most Western countries already have a very mature regulation system in place, and obviously still essential information does not meet the eye. Are we then creating sham-safeties by such regulative policies?

Suggested public availability of raw data might increase possibilities for external control. However, the problem of being dependent for information on industry cannot be solved this way, and checking data analysis would still require a lot of time and effort for researchers and/ or journalist to investigate. In the meantime we might consider the value and possibility of marking articles with a ‘reliability’ factor based on the level of credibility attributed by a journal to a specific article. Such a reliability factor could be based on criteria like transparency of data, accessibility for external controls, financial and non-financial interests, and perhaps also more subjective criteria like reputation of the funders, authors and researchers. Adding such a factor would certainly not solve reliability problems, but could make differentiations in reliability of articles (and journals) more transparent for researchers, physicians, patients and IRB or MREC members etc. And moreover, this would hopefully stimulate industry to actually show transparency and more general publicly responsible conduct. EQUATOR, a network concerned with accurate and transparent reporting of health research, could play an important role in the development of criteria for different reliability levels.


BMJ 2009;339:b5405

Website; visited 14-12-2009


Competing interests: None declared

Competing interests: None declared

Patricia Jaspers, PhD Student

Dep. of Health, Ethics & Society Maastricht University, 6229 ER , The Netherlands

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