Ten-year-old Ben Brenners' tiny fingers have been stabbed with metal lancets 11,000 times since he was diagnosed with diabetes at age 4. It's the only way to test when he needs insulin to stay alive.
Now companies are racing to sell the first pain-free tests to check diabetics' blood sugar, using everything from a special wristwatch to infrared light. But it's a tough technology to get right - and one fraught with political pressure as diabetics clamor for the tests."I know the technology's not perfect yet . . . but it shouldn't be kept from patients," argued Ron Brenners of Dallas, Ben's father, who spurred a congressional investigation into why one test suffered a serious setback at the Food and Drug Administration.
"There has been a tremendous amount of politics in this discussion," responded Dr. Susan Alpert, head of the FDA office that deals with medical devices. "Our focus was the science. . . . We are looking for a reliable product they (diabetics) can trust."
Diabetics' bodies cannot regulate glucose, or blood sugar. Millions stay alive by controlling their glucose with insulin shots, which they time by pricking their fingers several times a day to check their blood sugar.
But some 70 percent don't test themselves daily, something doctors hope will change with non-invasive tests. Three companies are vying to sell the first:
- Cygnus Inc.'s GlucoWatch has a pad that sends tiny electric currents into the skin to transfer glucose ions to a wristwatch that provides hourly glucose readings at the touch of a button. Clinical tests in several hundred diabetics begin later this year.
- Biocontrol Technology Inc. bounces infrared light through a patient's arm, measuring how far from ideal the glucose level is. But the FDA's outside advisers last month unanimously rejected the Dia-sen-sor, calling it too inaccurate.
- Futrex Inc. would beam infrared light through a finger, and began testing last year.
The technology is under intense scrutiny. The House Commerce Committee last year attacked the FDA for not passing Biocontrol's Diasensor - and after last month's public rejection by FDA advisers, diabetics demanded new hearings. They allege the FDA's chief adviser, Dr. Julio Santiago of Washington University, has financial interests that make him biased against Biocontrol.
The committee immediately began investigating.
Santiago, editor of the journal Diabetes, told The Associated Press he charged his typical $1,000 daily fee to tell a Biocontrol competitor two years ago that its noninvasive test wasn't ready to sell. He has consulted for Miles Laboratories since 1986, but said he worked only on Miles' laboratory tests, not invasive glucose tests, since 1991.
Santiago said the diabetics - and now Congress - ignored science. Of 23 patients tested for a month, the Diasensor worked in only eight - and even in those eight, it gave accurate readings only half the time.
The Diasensor rejection "should not be seen as a setback to the technology," Santiago emphasized. "It should be a warning that you should have your stuff together before you . . . try and foist this upon the public."
Indeed, Cygnus President Gregory Lawless touts his GlucoWatch as the first way diabetics could get as many as 24 glucose tests in a single day, and set an alarm to wake them if their levels start dropping at night. But he said he won't seek FDA approval until he proves the watch works.