Yesterday, Pieter Droppert, the writer of the wonderful Biotech Strategy Blog, called out Bristol-Myers Squibb for a long delay in publishing a study of its drug Yervoy in prostate cancer. Bristol announced that the trial failed last July in its earnings press release, but there has been no data and Droppert cites experts in the field who suspect the trial was being buried.
Not publishing negative trials is a big deal. It gives researchers and doctors a twisted perception of what the data about a medicine actually says, and therefore both harms patients and slows progress. I asked
This was the company's response:
We are dedicated to sharing our clinical trial information and data consistent with the industry associations’ Principles for Responsible Clinical Trial Data Sharing. In July 2015, we disclosed that Study -095 did not meet its primary endpoint and was discontinued. Since that time we have been working with investigators on analyzing these data and preparing a manuscript for publication. The manuscript is being submitted in early Q32016 for publication consideration.
That's still a long--and not really acceptable--delay. Positive studies are rushed out in months, but this one has been allowed to sit around for more than a year before it is even submitted for peer review. But better late than never, and now Bristol knows people are watching which should (fingers crossed) prevent more delays. Patients volunteer their bodies and their time for these studies, it's just wrong to not release the resulting data as quickly as possible.
