Norman Dann:
Transcript of Interview Excerpt

Norman Dann, interviewed by David Rhees on July 23, 1998 at The Bakken Library and Museum, Minneapolis, Minnesota.

“Well, at any rate, my encounter with it, I think the industry should be regulated, but I think it has to be regulated with an understanding of this process, and I think what’s missing yet—maybe it’s getting a little better, it’s hard to tell—is how to reach a middle ground where you can permit devices that you know are going to undergo change to be initially tried in patients and establishing protocols for doing that.

The problem is that these are almost all judgment calls, and they’re very tough to write down in regulations. I think that’s the stumbling block. We’ve tried to decree that. Now, by the way, in Europe, they don’t bother with that process. What they say is, they prescribe the protocol for what’s required to do testing, but they don’t determine the test. In other words, they say you will be at a first-class institution or one where you have people that are totally qualified and that their understanding of the experiments or the testing have to be taken into account by the manufacturer.

But they stay out of the process of making the judgment calls. People involved in the procedure make the judgment calls, which is, by the way, the way it was before we had any regulations. I mean, you sat down with the physician and he said, “Well, I think if you did this and that, I’m willing to give this a shot.” And he made the risk-reward tradeoff in his mind, saying, “For this patient, the risk is worth it, based on what alternatives I have.” And that is the way you make progress. You don’t eliminate risk.

I think the trap we’ve fallen into is to try to tell the American people that the FDA [Federal Drug Administration] can eliminate risk. And, by the way, there’s been no assessment of whether we, in fact, have made any progress in that area with these regs. We do a lot of studies, but I have not seen, to my knowledge, a study that says, “By the way, regulated products are safer than the unregulated products were.”

Again, the industry is much larger, we have a lot more players today, and I think there should be some regulation, but I think we need to understand what you can regulate and what you can’t, and I don’t think we’ve cleared that one up.”