"The market for these diagnostic (PET) tests is minuscule compared to these blockbuster drugs that are used for therapy. So big pharma doesn't invest."

DMBN: Do you think that the FDA is just way out of line with this toxicity testing?


HW: It's not a moral issue, it's an educational issue. Those guys all grew up with stable drugs, and it is very difficult to move these big bureaucratic organizations, so I would not put blame on them. It is just that there has to be a paradigm shift. In fact, I think it may happen. Healthcare is one of biggest issues in the country right now, and I hope that we can come up with some real simplifications that will really help new PET pharmaceuticals. Now's the time to come up with new regulations. I know they're working on it, but they are taking some time.

DMBN: Since PET tracers are tiny micro-doses, should the toxicity test go away?

HW: You don't want to eliminate toxicity testing, although it can be greatly simplified because many of these potentially new tracers are natural body constituents. You would do single-dose, single species toxicity testing, so instead of costing $500,000, the goal would be to get it down to $100,000. That's a step in the right direction.

DMBN: But the biggest cost is the clinical trails, can that be streamlined?

HW: The hurdle here is the way the FDA thinks about clinical trials. In other words, if I have a radiopharmaceutical that mentions chlorine in a particular part of the body, I believe that the FDA should just ask, "What is the evidence that it really does show the chlorine?" They insist it's not enough to show the chlorine, it has to help patients who have cancer of the prostate. That's like saying if you're going to get approval of a thermometer, you have to show it helps patients with pneumonia. I think there are problems and they're not being changed fast enough to suit me.

DMBN: What about the other part of the economics, reimbursement. What are you hearing about reimbursement for PET or PET/CT scanning?

HW: I know it's been very profitable, but it is being cut back some, which bothers a lot of the people that are operating imaging centers.

DMBN: Are DRA cuts the problem?

HW: It's one of the things-it's an extremely profitable type of activity, and the profit has now been reduced by those government actions. And will they be extended to the university hospitals? Almost certainly, I think.

DMBN: Assuming the regulatory issues are worked out, what do you see for the future of PET/CT as an imaging modality?

HW: It's a fantastic-I'm working on an article right now called "From Molecular Imaging to Molecular Medicine," and the subtitle is "The Impact on Health Care Has Just Begun." Just try and think for a minute: here we have the ability to measure virtually any molecular activity in any region of the body - can you imagine what potential that has? So in my opinion, PET/CT can't miss. But it's a complex field, and it's got huge regulatory burdens. I discuss the finances in this article to show how money really can be saved. One thing's for sure: keep an eye on PET.

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