PET's isotopes with half-lives of 2 hours to 2 minutes eliminated the large radiopharmaceutical supplier from the business model. Without the large manufacturer's involvement the tasks of educating the referring physician, and seeking FDA regulatory approval, were now spread over hundreds of small, independent and sometimes competing imaging centers and nuclear pharmacies.

The short half-lives of the PET isotopes eliminated the large manufacturer from the nuclear medicine business model. This made it very difficult for PET to succeed. The equipment vendors added more fuel to the fire when they implemented a strategy in the late 1980s that sealed PET's fate.

THE EQUIPMENT VENDORS' PLAN


In the late 1980s and into the 1990s there was great frustration on the part of the PET scanner manufacturers because there was no reimbursement. Siemens had purchased a major share of CTI. GE Healthcare joined in with the purchase of Scanditronix. The marketplace thought this would bring PET into the clinical arena, encouraging sales of equipment and Medicare reimbursement. To everyone's surprise nothing happened.

The equipment vendors examined the radiopharmaceutical manufacturers' approach to product introduction and believed that, to get PET procedures reimbursed by Medicare, the marketplace needed FDA approval of PET radiopharmaceuticals.

18FDG was the obvious candidate for the FDA approval process. It was the most widely used PET imaging agent by those who either made their own or bought it from the local nuclear pharmacy's operating cyclotrons.

18FDG was chosen because the fluorine -18 tag (with a 2-hour half-life) on deoxyglucose made it possible for the nuclear pharmacy to transport the radiopharmaceutical 30 minutes away by automobile.

If the equipment vendors were correct then, with 18FDG approval by FDA, reimbursement from Medicare would soon follow. They believed that with reimbursement the PET scanner market would expand, dramatically increasing unit sales. Unfortunately, after several years, millions of dollars and an FDA approval for 18FDG there still was no reimbursement. Medicare reimbursement didn't begin to happen until late 1999.

Taking the path of FDA approval for 18FDG set a precedent for the future approval of all PET radiopharmaceuticals. From this point forward new PET radiopharmaceuticals would have to go through the FDA process. But, who would take on such a large and costly assignment? Would the local nuclear pharmacy, a hospital or an imaging clinic shoulder this expense? The answer is no one would. No small producer could justify the expense.

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