Imagine: a large stent development company places their new stent in the hands of a clinical investigator. The clinical investigator does the early cases with a new stent, but the results of the study run counter to the company’s expectations. Those problems are reported at a national meeting. The stent company, OrbusNeich, isn’t happy that things didn’t turn out the way they had expected because they believe the problems identified could be explained away on other grounds.
So what do they do?
While I do not know the circumstances surrounding the case, I find it ironic that the company is suing for defamation, when they, themselves, have just electronically done the same thing: defamed the doctor and the hospital in question before trial.
Maybe the doctor didn’t want to adjust the results because he believes in his assessments of the complications in this study. Maybe the heavy-handed efforts to discredit his findings are a result of the company’s strategic development goals. Then again, maybe the investigator did screw up – does that mean they should resort to a press release and suit? What have others found with their device?
As previously reported in theheart.org:
Assigned to formally comment on the study after Cervinka’s presentation, Dr Jeffrey J. Popma (St Elizabeth Medical Center and Harvard Medical School, Boston, MA) observed that the study was small but strengthened by "meticulous attention to details, standard clinical, angiographic, and [intravascular ultrasound] IVUS definitions, and concordance of anatomic and clinical end points."
So, he said, "the results are quite believable. And although the conclusion was that this study was just too small to demonstrate clinical benefit, I think it’s too large to dismiss the stent thrombosis that occurred following placement of the Genous stent."
Clinical research is difficult enough, but the practice of holding the specter of legal proceedings over the head of clinical investigators when results are counter to corporate expectations should send a warning to any other doctors approached to serve as clinical investigators for this company…
… run, don’t walk, away from these guys.
Reference from theheart.org: The earlier review of the disputed report made at the 2009 ACC Meeting in question.