Triggering the Alltrials campaign
The New York Times has a detailed story about one of the triggers for the Alltrials campaign, the missing studies of Tamiflu
He was curious about one of the main studies on which Dr. Jefferson had relied in his previous analysis. Called the Kaiser study, it pooled the results of 10 clinical trials. But Dr. Hayashi noticed that the results of only two of those trials had been fully published in medical journals. Given that details of eight trials were unknown, how could the researchers be certain of their conclusion that Tamiflu reduced risk of complications from flu?
Only about half of all randomized clinical trials are published, despite regulations requiring publication, and the requirements of the Declaration of Helsinki
Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.
Since the obvious conclusion is that the unpublished studies are less favorable than the published ones, patients and the medical community cannot be sure about the benefits of even the most promising treatments. The uncertainty always matters at least to a small group of patients, but in the case of Tamiflu it matters to the whole world. The 2009-2010 influenza pandemic was relatively minor, but still killed more than 250000 people worldwide (by most estimates, more than the Iraq war). The 1918 pandemic was at least twenty times worse. Before it happens again, we need to know which treatments work and which do not work.



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