"It's a simple fact that without Ted Stevens and Liz Connell, we would not enjoy the privileges that we have today with PET," said Phelps, who is a co-founder, board member and major shareholder in the nation's leading PET company.
"We ran into a lot of people . . . who were obstacles," Phelps said, speaking to scores of PET experts Sept. 8 during a conference focused on winning even more influence in Washington. "Guess what? They're all gone! That was Liz. So we all appreciate Liz."
Lagging Profits
Unlike magnetic resonance imaging (MRI), the widely used imaging method that creates fine-grained photos of the body's interior, PET does not reveal physical or anatomical structures. Rather, it shows places where the body's metabolic processes are out of balance. It does so by tracking radioactive chemicals injected into the blood.
A typical $2,000 PET scan can highlight, for example, spots in the body where greater-than-normal amounts of sugar are being consumed -- evidence that too much growth is going on, probably by a glucose-guzzling tumor.
PET and MRI were both invented in the early 1970s, but PET has lagged far behind in approved uses and profits. The 1,000 or so PET scanners operating in the United States today account for less than 5 percent of the more than 50 million diagnostic imaging procedures conducted annually.
Not least among PET's impediments was the Food and Drug Administration's discomfort over the chemicals, which can emit in one procedure the radiation in dozens of chest X-rays. It was not until 1998 -- after Stevens and Connell crafted legislation to speed FDA approval of those chemicals -- that Medicare agreed to cover PET for the first time, to spot lung tumors.
Since then about a dozen other cancers have been added to the list, as studies showed PET's value for finding them. But the industry has long had its eye on a bigger prize.
Alzheimer's disease already afflicts more than 4.5 million Americans -- a number that could grow to 14 million by 2050 -- and countless aging baby boomers will soon want to know if their memory problems are early signs of the disease.
No test short of an autopsy can establish with certainty that a person has Alzheimer's, though doctors can usually do so on the basis of symptoms. The challenge for PET was not only to show that it could diagnose Alzheimer's better, but also to prove that such an improvement made a difference for patients -- a difficult task, given the very modest benefits that come with today's Alzheimer's drugs.
After a study done for CMS said it made more sense to simply give the drugs to everyone thought to have Alzheimer's, CMS refused last year to cover PET for the disease.
