Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, had visited the Glaxo Wellcome clinical trials site, which contains data on drug trials. Nissen made an observation, based on Glaxo Wellcome's own data, that shed new light on the risks of cardiac side-effects with Avandia.
Without going into any of the specifics of this particular finding, I would just like to comment that Glaxo Wellcome made a valuable contribution to medicine simply by opening its clinical trial data to public review.
Research reports are always misleading. This is not because the authors of research reports are liars (although I'm sure that lying sometimes occurs), but because it is human nature to describe research findings in a way that supports a self-serving view of reality. That is why the primary data upon which research findings are based must always be open for public review.
By releasing de-identified clinical data to the public, the data can be reviewed and analyzed to yield fresh insights. Yes, sometimes public review may yield faults in the study that were overlooked by the original authors. Sometimes public review may yield conclusions that the original authors would rather not entertain. My personal hope is that more often than not, review of the data will yield new opportunities, new discoveries and new hypotheses that will benefit everyone.... and that will particularly benefit the original creators of the data. Ultimately, review of public datasets will support integrative studies that combine speficied data from many different studies to produce important results that were unanticipated by any of the original data creators.
-Jules Berman
In June, 2014, my book, entitled Rare Diseases and Orphan Drugs: Keys to Understanding and Treating the Common Diseases was published by Elsevier. The book builds the argument that our best chance of curing the common diseases will come from studying and curing the rare diseases.
I urge you to read more about my book. There's a generous preview of the book at the Google Books site.
tags: common disease, orphan disease, orphan drugs, genetics of disease, disease genetics, rules of disease biology, rare disease, pathology, clinical trial, data integration, data review, open access, trialists
