Diabetes screenings stir concerns
Tuesday, December 7, 2010; 12:44 AM
Federal health officials are investigating the use of finger-prick blood tests to screen Americans for diabetes, one of the nation's fastest-growing and most serious public health problems.
The quick tests were approved to monitor patients, and some may be far less accurate for diagnosing the ailment, erroneously alarming people that they have the incurable, life-threatening disease or falsely lulling others into thinking they are healthy, delaying care that could prevent serious complications.
"You wouldn't want to be told you have cancer based on an inaccurate test. Diabetes is a serious disease - something you're going to have for the rest of your life and threaten your life. You need to use an accurate test," said M. Sue Kirkman, the American Diabetes Association's senior vice president for medical affairs and community information.
Doctors have long used some versions of the test, known as the A1c test, to track how diabetics are faring. The American Diabetes Association earlier this year endorsed expanding their use to diagnose the disease, to help identify the millions who don't know they have it. But it specified that only A1c tests performed by highly skilled, closely regulated laboratories should be used for diagnosis. The concern is about the use of some quick over-the-counter A1c tests that have not been validated and are not carefully monitored.
The testing illustrates the unexpected consequences that can occur when the discovery of better ways to diagnose and track diseases mixes with commercial interests that turn those discoveries into simple, cheap tests and well-intentioned policymaking inadvertently fuels their use. The situation also highlights legal loopholes that can leave federal regulators with few options to crack down on the tests' misuse.
"I have grave concerns," said David B. Sacks, a professor of pathology at Harvard Medical School who chairs the National Glycohemoglobin Standardization Program, the federally funded effort to improve diabetes testing. "We have absolutely no way to know how accurate or inaccurate these tests are, who's performing them and whether they're being performed correctly."
How widely the tests are being used is unclear, but people are being tested at drugstores, doctor's offices, health fairs and corporate "wellness" days. CVS says it is offering the tests at 21 of its MinuteClinics in Virginia and two in the District as well as in 21 other states. Walgreens Co. tested about 30,000 customers free of charge at some 1,700 stores across the country, including one on 22nd Street NW in the District, in November 2009 and 2010, according to spokesman Jim Cohn.
"By offering free testing we're providing a valuable health-care resource," Cohn said. "These tests are not used to provide a clinical diagnosis or recommend any treatment. What we do is provide patients test results and encourage them to report the results to their primary-care provider."
The tests also are offered by some firms specializing in health screening events for customers and employees at retail stores, large office buildings, factories and other businesses. Companies nationwide, for example, have been hiring OptumHealth of Golden Valley, Minn., to provide free A1CNow tests to their employees as part of their wellness programs, said OptumHealth spokesman Charles Grothaus.
"We do health screenings at pharmacies and retail outlets throughout the Southeast," said Allen Tedder, operations manager for CholestCheck Corp. in Greenville, S.C. CholestCheck sells Bayer's five-minute A1CNow test for $40 at health fairs.
"We don't actually diagnose. We give the results, and it's up to them to decide whether to talk to their physicians. We don't offer any advice on what they should do," Tedder said. "It's a wellness program for the stores so they can get their customers to come in and maybe get people to their pharmacies. It also helps make people in tune with their health who may not get medical services."
The tests are used primarily for Type 2 diabetes, the most common form of the disease - more than 23 million children and adults in the United States suffer from the illness. Type 2 diabetes is increasing rapidly because of biological, sociological and demographic trends, including the obesity epidemic, the aging population and immigration of prone ethnicities.