Subject Safety Problems – Not An Isolated Incident
Sometimes I wonder if NYU had any idea of how often the safety of their human research subjects was being placed at risk – but how could they not know?
The FDA dinged them on multiple violations for the Pfizer drug trial (Protocol #B0541013), however that study wasn’t the only one in which NYU’s regard for subject safety is questionable. An earlier brain imaging study (S12-01521), a collaborative effort between NYU and Yale, had problems as well.
As I mentioned in my open letter to NYU, one of the incidents that I believe jeopardized my safety was being put on a plane so quickly upon my release from the Yale PET Imaging Center. I had had an arterial line placed, and upon its removal and bandaging I was literally immediately put in a cab and sent to the airport.
Not only does this violate NIH guidelines for post-arterial line care, but also the post-care instructions given to me by the institution that conducted the scans – Yale School of Medicine:
- No bending affected arm or wrist for 4 hours
- Refrain from strenuous exercise, reaching, or lifting heavy objects (no more than 5 lbs,) for 48 hours
According to my Informed Consent documents given to me by NYU, I was to stay at the PET center for up to an hour to make sure that I did not have any problems or reactions from the radiotracer used in the study. That obviously didn’t happen. And I would have happily abstained from any physical exercise as per instructions in order to prevent complications, but I had a flight to catch. NYU violated its own guidelines.
So why was I on a plane so soon after my line was removed?
As a direct result of NYU’s scheduling, I ended up stranded in an airport mid-mental melt down with a pressure dressing on my arm (that I’m supposed to somehow take care of while travelling) in the middle of the night, fending for myself.
What would have happened had I had a complication mid-flight? I had a line in my artery less than two hours before I was in the air – and that is WITH a flight delay. What if I would have started bleeding at 35,000 feet?
Should that not be a safety issue that needs to be addressed – or is this how all subjects are treated?
So many questions, so few answers, and such little accountability.