New Diabetes Campaign Raises Controversy

Nov. 18, 2004 — -- A national public service campaign aims to convince individuals with Type II diabetes that getting a simple blood test will help them stay healthy, but some doctors fear this strategy may lull diabetics into ignoring other serious health concerns.

A coalition of 50 U.S. mayors and health advocates brought its message to Washington today to launch the effort, called "Aim. Believe. Achieve: The Diabetes A1C Initiative." The goal is to raise awareness of a test for hemoglobin A1C, a molecule formed when sugars bind to hemoglobin circulating in the blood.

The test is usually performed every three or four months, usually in a doctor's office. The physician needs just a drop of blood to read the patient's A1C value.

Most diabetics are already experienced at checking their blood-sugar levels frequently during the day using a home device. But these blood-sugar tests show a patient's level at a single point in time, and levels may fluctuate wildly with diet and after a patient takes medications. An A1C test reflects a person's average sugar levels over a two- to three-month period, giving a more stable picture of blood-sugar control.

Proponents of the initiative argue this is the best way to discover how effective treatment has been. They say diabetics should have their A1C checked frequently, aiming for a value of less than 7 percent.

Diverting Attention From Other Problems?

But some in the medical community believe the campaign -- largely funded by Aventis, maker of the Type II diabetes medication Amaryl -- will mislead patients into believing that keeping their blood-sugar level within normal limits is a cure-all for the disease.

"Imagine you are a doctor sitting in front of a patient with Type II diabetes holding up your hand with all five fingers extended," said Dr. David Slawson, a professor of family medicine at the University of Virginia.

"The thumb is smoking, the index finger is blood pressure, the third and fourth fingers are lipids, aspirin, and a particular diabetic medication, metformin, and the pinky is blood sugar," he said. "The first four fingers dwarf the pinky, which is the least important, if at all."

Approximately 11 million Americans have Type II diabetes, characterized by an elevation in blood sugar caused by an improper response to insulin, the molecule responsible for keeping these levels in check. This type of diabetes usually begins in adulthood and is often associated with obesity, a sedentary lifestyle and aging.

Despite efforts to educate the public and the advent of new medications to help decrease blood glucose levels, studies show that the number of individuals with the disease may double in the next 20 years.

As this figure increases, so will the incidence of complications of diabetes. The complications are divided into "small vessel" diseases such as blindness, kidney disease and restricted blood flow to lower extremities that can result in the need for amputation, and "large vessel" diseases such as heart attack and stroke. Treating these adverse effects costs the U.S. health-care system $132 billion a year, according to the sponsors of the A1C campaign.

Advocates for the A1C campaign argue that checking the hemoglobin A1C level is an easy and effective way to indicate how well a patient's diabetes is being controlled.

"Focusing on A1C is not meant to argue that other factors are unimportant," said Dr. Nathaniel Clark, vice president for clinical affairs of the American Diabetes Association and a speaker at today's event. "But in terms of complications from small vessel disease, evidence shows that blood sugar control is the most important factor."

How Important Is A1C?

Clark's view is bolstered by a number of clinical reports over the past decade, which showed that even slight decreases in A1C resulted in lower rates of small vessel diabetic complications.

Studies show only one-third of patients with Type II diabetes know their A1C value. Over the next several months, the campaign will be producing television and radio public service announcements, providing free A1C screenings in major cities, and lobbying federal, state, and local legislators for support.

But many physicians, including Slawson, believe that blood-sugar control, while helpful, is a relatively unimportant intervention.

"When you look at the evidence, there are a number of things you should do first that have far more benefit than lowering your A1C," he said. "Worrying about blood sugar in a patient who doesn't pay attention to these other, more pressing, issues is tantamount to rearranging furniture on the deck of the Titanic."

In an article published in the British Medical Journal last year, Slawson and his colleagues analyzed the effectiveness of standard treatment practices for patients with Type II diabetes. He concluded that although researchers have found blood-sugar control to be of marginal significance in preventing diabetes-related complications, doctors continue to be fixated on tests such as A1C because they have failed to analyze some of the most recent evidence on the topic.

Drug Company Influence Criticized

Other doctors believe the push to closely track and control A1C levels has little to do with medical evidence and more with the influence of drug companies.

"We're faced with theoretical and indirect evidence of the benefit of tight control ... and enthusiasm from experts who uniformly are affiliated with diabetes drug companies," said Dr. Jay Siwek, chairman of the Department of Family Medicine at Georgetown University and editor of the journal American Family Physician.

"As an editor, I've received papers extolling and urging the importance of tight control from industry-sponsored experts, none of which mention the problems of uncertain efficacy or the difficulty in trying to achieve tight control," he said.

Many physicians, however, stand by the data published in medical journals.

"There are at least five studies, starting in 1993, that specifically show that the goal number of 7 percent [A1C level] is extremely important to reach in order to markedly delay or possibly prevent the complications of diabetes that lead to blindness, kidney failure, and amputations," said Dr. Mayer Davidson of Charles R. Drew University in Los Angeles, a former president of the American Diabetes Association. "There are hundreds of other studies that show that the more one lowers the A1C, the less likely there will be these complications."