Surgical innovation and ethical dilemmas: A panel discussion
IF TESTING MOVES OFFSHORE, CAN ETHICS FOLLOW?
Dr. Lieberman: I am going to paint a scenario on which I would like each panelist to briefly comment. New Device X is backed by a big vendor. It is a great device, but because of all the regulatory issues in the United States, it is taken to China or South America and is being implanted there, where the regulatory environment is much more lenient. Can we rationalize this practice? How is it possibly ethical?
Dr. Fins: I can answer in 5 seconds: we shouldn’t do it.
Dr. Rezai: This is a reality we are facing with increasing rules and regulations in the United States. You have to engage the process, and it takes time. If you have colleagues who can follow clinical trials outside the United States, you can have the device tested outside and then bring it back to the United States. Unfortunately, the reality is that the regulatory process can be slow, so more testing will be done abroad, in my opinion.
Dr. Hahn: I disagree with Dr. Fins. This may be the only way to get the trials started, and we then are able to use some of the offshore data to approach the FDA for approval. I do not think that it is taking advantage of anybody; it is a way of getting things through the system.
Dr. Herndon: The door has been opened, and it is only going to increase. My only request would be that the investigators who do this function as they would here in the United States, under IRB controls and the other kinds of oversight that they would expect and demand of themselves in their own institutions.
