FDA IGNORES DIABETICS' PLEAS, SAYS TESTING DEVICE NEEDS WORK.

Byline: Associated Press 

Diabetics pleaded with the government Monday to approve the first pain-free way to measure their blood sugar, but a panel of experts said there was no proof the machine works well enough to keep their disease at bay.

"I will apologize to every diabetes patient . . . in this room that I cannot be more enthusiastic," said panel chairman Dr. Arthur Karmen of Albert Einstein College of Medicine. "But hopefully what you want to get is the right answer" from a diabetes test.

The Food and Drug Administration advisory committee decided Biocontrol Technology Inc. needed to study its Diasensor again - but quickly - to prove it could be used safely. So far, its only evidence showed that Diasensor could test perhaps one of every four insulin-dependent patients.

Biocontrol argued that those patients deserved to use the machine, the first noninvasive blood-sugar test, while scientists figure out how to improve it.

Angry diabetics agreed.

"I can't tell you how frustrating it is to know this device exists but is just out of reach of Bonnie," said Glenn Sklar of Columbia, Md., who draws blood from his 3-year-old's finger six times a day to control her disease.

"The way I test hurts me now," 10-year-old Ben Brenners of Dallas told the committee. "Please allow me and other diabetics to have this device."

The FDA is not bound by advisory panel decisions but usually follows them, and FDA device chief Dr. Susan Alpert immediately asked Biocontrol to meet with her this week to figure out how to proceed.

But with the test being questioned, Biocontrol's stock plunged almost 41 percent Monday, even before the committee's decision.