Another big factor is, "the pharmaceutical industry is interested in blockbuster drugs, not diagnostic tracers, they don't put the importance of radiopharmaceuticals where they should be," Dr. Wagner asserts. For example, if you introduce a diagnostic PET tracer, it costs $500,000 just to do the toxicity testing, even though you're giving 1/100th or 1/500th of the toxic dose.

"The core problem is it costs tens of millions to get one of these new PET agents approved for clinical use," Wagner notes, "and there's nowhere the profit in radiotracers that there is in, say, a cholesterol-reducing drug. Big Pharma is interested in billion dollar drugs, so they don't put the money into diagnostic radiotracers. It really needs to be done by small companies."

Unless something changes with Big Pharma, radiotracers are going to need legislative support with the financial funding behind it and heavy promotion by the industry before the FDA approves it.

It is somewhat ironic, as Dr.Wagner noted, that Big Pharma is using PET studies in development of new blockbuster drugs. By turning the drug into a radiotracer, PET scans let researchers see which formulations are absorbed the best and work the best.

The DRA-effect

In predicting what will happen next in the area of nuclear medicine, Alexander J. (Sandy) McEwan, President of the SNM, observed, "the DRA, which clearly has impacted all modes of imaging, is significantly affecting the way in which new technology is going to be introduced. For example, FDG-PET scanning at the moment is broadly accepted, but CMS [Medicare/Medicaid] is currently re-evaluating the next generation of tests."

The current probes look at glucose metabolism, but the plan is to develop probes to examine other parameters of disease activity-such as proliferation, hypoxia, and receptor status. "Over the course of the next few years you will see clinical trials started that will look at what we think is the next generation of probes," McEwan observed, "and then hopefully over the next 5-10 years you'll see those new probes introduced."

The challenge, as McEwan put it, is to find a way for the healthcare community, industry, academia, and the clinical community to work together to get CMS to look favorably on those probes, so they actually get put into use.

Growth in the industry

One of the biggest things to happen in the field of molecular imaging in the past few years is the acquisition of CTI Molecular Imaging by Siemens in 2005.

"When we acquired CTI molecular imaging we spent $1 billion for it," says Markus Lusser, Vice President of Sales & Marketing for the Siemens Medical Solutions Nuclear Medicine Group. "We expanded our product portfolio not only in the traditional equipment side, but we invested into biomarker research. We aggressively invested into preclinical imaging as well as the largest distribution network for biomarkers, a clear sign of our commitment in the molecular imaging arena and especially biomarker development. There are early signs that in the future there will be many biomarkers for certain indications

More Industry Reports