‘Bureaucreep’ pushes the envelope

Faith in democracy and U.S. politics has led many to believe that politicians run this country. They do not. The real holders of power are career bureaucrats, the GS-10s, 11s, and so ons who write memoranda, staff committees, and order studies. They know the rules of engagement. They are at their desks long after elected officials have been voted out.

Any feelings of comfort about the consistency this might lend to government should vanish when we realize that the competitiveness that drives the private sector has a counterpart in the federal government, where agencies commonly battle each other for authority and control, much as companies fight for market share.

An example of how this can negatively affect the public is now unfolding at the Health Care Financing Administration. With its decision to examine the relative merits of devices capable of positron imaging, HCFA has invaded turf held by the FDA. This agency, charged with administering billions of dollars in Medicare funds, has chosen to pass judgment on the efficacy of full-ring PET scanners versus that of coincidence detectors, even though the authority to make such decisions clearly rests only with the FDA.

In so doing, HCFA has exposed its Achilles’ heel - an inordinate reliance on published reports and a suspect ability to interpret them. Lacking in the agency’s interpretation is a basic understanding of physics - that coincident events (i.e., the release of gamma particles) caused by the annihilation of positrons and electrons occur at points 180º apart. In other words, a modern coincidence camera with its two detectors locked in a 180º position will pick up the same events as a full-ring detector. The only difference will be in the number of counts recorded over a set period of time. Resolution, therefore, becomes a matter of time - full-ring detectors offer high throughput; coincidence cameras offer lesser throughput.

Certainly there are differences in sensitivity depending on the thickness of the crystal and even in the crystal material itself. But these are issues best examined by the FDA, not an overzealous organization composed of accountants.

If HCFA is unhappy about the kinds of devices cleared for sale in the U.S. for positron imaging, its administrators should bring their concerns to the FDA. Meanwhile, they should stay out of what they do not understand.