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" ... "The interim results of the Light Trial were released to a small unblinded Orexigen team by the Data Monitoring Committee under strict rules that allowed access for the purposes of regulatory filing. No public release of these data was anticipated and was not approved by the DMC or Executive Committee. It would not be appropriate for me to comment on preliminary interim data derived from an ongoing outcomes trial that is still underway." ... "
" ... GSK supplied the files used by Duke to re-adjudicate the RECORD Trial. Given the unblinded nature of the study, how can this process be viewed as independent. Duke could only adjudicate what was provided to them by GSK. Given the pending court cases against GSK, the company was strongly incentivized to provide the information in a way designed to bias the outcome. ... "
" ... Overall, I’m proud we published this piece. I continue to believe that the observations by Chris Rajkumar and his colleagues are quite novel and worthy of discussion. They are based on a careful read of the literature and raise fundamental issues about how the scientific community should assess endpoints in unblinded clinical trials - a topic that our journal cares deeply about and has published previously on. ... "
" ... We have three sources of data regarding Avandia. The meta-analyses, include FDA's, show an increased risk of heart attack ranging from 40 to 80%. The observational data virtually all show an increased hazard for MI. The outlier is RECORD and it was a fatally flawed trial, completely unblinded to patients, physicians and GSK. ... "