December 10, 2013
The NYT had an interesting piece on a dispute over continuing a clinical trial of a heart device that has been tied to a number of incidents of blood clots. While the device had originally been used in patients who likely risked death without it, the trial is designed to examine its effectiveness in patients with less severe heart disease. The incidents of blood clots raise the possibility that the risk exceeds the potential benefit.
At one point the article noted that the doctors working with the device maker continue to defend the safety of the device and intend to continue the clinical study. It then quotes a cardiologist at Duke, one of the authors of a study showing the higher incidence of blood clots, who notes that these doctors had spent years setting up the trial:
“They are more apt to look at the data that suggests there is less of a problem, …”
It would have been worth noting that in addition to the time they spent setting up the study, they also likely stand to make a substantial amount of money if the device is approved for use in a larger group of patients. This is a function of patent support for the research and development of medical devices.
It is likely that researchers will want to defend their research in any case, since they will be reluctant to accept that years might have been wasted. However the incentive to pursue a line of research even if new evidence suggests it is counterproductive will be much greater if there is potentially a large monetary reward. At least, this is what economic theory predicts.