Type 2 Diabetics Face a Flood of Drugs and Tests

At the American Diabetes Association’s traveling EXPO, many exhibitors have their eye on the prize: People with Type 2 diabetes. Clinilabs offers such patients more than $3,500 to join a drug trial. Sanofi-Aventis has 10-foot-tall insulin pens on display. Walgreens offers a free test to check long-term blood sugar levels, a promotion for a new home-testing kit.

Type 2 diabetes, which afflicts an estimated 25 million Americans, is one of the new frontiers for drug and device makers. As more and more people are given the diagnosis, more products are being been developed to tap into this multibillion-dollar market. But some experts say that for many patients the profusion of choices has often led to confusion, not better treatments, as well as skyrocketing costs.

“There are now 12 classes of drugs, many of them expensive, and the question is, are we any better off?” said Dr. Silvio E. Inzucchi, director of the Yale Diabetes Center. “You can control glucose with generics for $4 a month or some new ones that are $8 or $9 per pill. Some medicines are 100 times more expensive, but they’re certainly not 100 times as effective. In fact, they’re probably equal for most people.”

Unlike those who suffer from its rarer and more dangerous cousin, Type 1 diabetes, in which the body stops making insulin in childhood, people with Type 2 diabetes typically do not make enough insulin or do not respond vigorously enough to the insulin they do make. As scientists have learned more about this complex process, drug makers have begun offering new medicines that target the cascade of reactions that starts with the ingestion of food and leads to the removal of glucose from the blood.

Type 1 diabetes is rapidly life-threatening if not treated with insulin. But Type 2 can usually be controlled with various treatments, though it can slowly damage vital organs over many years if not kept in check. Demand has grown for drugs, because the earlier that blood sugar is under control, “the greater the chance of reducing the risk of long-term complications,” wrote Mary Kathryn Steel, a spokeswoman for Sanofi, in an email.

While the disease can, initially, often be treated with changes in diet and exercise, there is usually little support and financing to help with such solutions. And there is encouragement aplenty to move on to costly drugs, including insulin, which most experts say is necessary for only a minority of Type 2 patients after other options have failed.

Judy Boncaro, 71, of Portland, Ore., was taking cheap generic drugs that had long controlled her Type 2 diabetes when a knee injury left her unable to exercise and her blood sugar started climbing. A doctor suggested that she start on an injectable drug called Byetta, which costs close to $500 per month, nearly double the price when it was introduced in 2006. She refused the treatment and is saving money to cover the co-pays for surgery on her knee.

When Juanita Neitling of the city of The Dalles, Ore., was given a diagnosis of Type 2 diabetes two years ago, at 75, her Medicare H.M.O. arranged for her to attend four nutrition classes and counseling. She is not diabetic anymore. But many conventional insurers would not have picked up the tab for such counseling, which can cost more than $1,500 annually.

Lacking comparative studies about the effectiveness of the new drugs flooding the market, the American Diabetes Association and its European counterpart convened a panel of experts in 2012 to recommend how to deal with the disease.

The first step is to lose weight, exercise and eat better, the panel found; much of the rise in Type 2 cases is linked to the growing incidence of obesity. The second step is an old generic drug called metformin, which reduces blood sugar and costs just pennies. But the panel concluded the next step was discretionary — up to the doctor and patient, weighing factors like convenience, side effects and cost. Options range from old, cheap oral medicines to expensive new injectable drugs and long-acting forms of insulin. (A large trial run by the National Institutes of Health to compare the new options is just starting and results are years away.)

Drug makers promote products to keep blood glucose in the near normal range — a treatment strategy called tight control. But many researchers debate whether tight control is important or appropriate for many people with Type 2 diabetes, since they do not typically experience the life-threatening metabolic disturbances and extremely high glucose levels of people with Type 1 of the disease. They usually do not suffer some of the most dreaded complications, like blindness and kidney failure. They tend to die of heart attacks and strokes, and only after many years.

“These new medicines reduce glucose,” said Dr. Inzucchi of the Yale Diabetes Center. “But if you control blood pressure and lower cholesterol, the added benefit may be lost for many patients.”

Dr. Robert Ratner, chief scientific and medical officer at the American Diabetes Association, said that doctors had to individualize therapy for patients: A 25-year-old trying to get pregnant or an active 35-year-old would merit aggressive control since they would live decades with the disease. An 80-year-old with Alzheimer’s might not derive benefit, and the risks of mistakes from a complicated injectable regimen could prove deadly.

Data from the Centers for Disease Control and Prevention suggest that more than three million Americans with Type 2 diabetes are on insulin today, a large increase compared with a decade ago, experts said. And studies show that growing numbers of them are arriving in emergency rooms unconscious from low blood sugar — generally a result of too much insulin or missing a meal. Many people who develop Type 2 diabetes when they are young will need combinations of different drugs as they age and the disease progresses. After a decade of living with Type 2 diabetes, Regina Lavasseur found that inexpensive pills were no longer controlling the disease and a doctor told her she needed insulin. Uninsured at the time, the 60-year-old Seattle resident bought insulin derived from pigs, the standard treatment a quarter century ago, over the counter (in some states only newer synthetic human insulin requires a prescription). Now, with good insurance, Ms. Lavasseur is on a once-a-day long-acting insulin, Lantus, that retails for over $600 a month for her dose, of which she contributes a small co-pay.

Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York, said many patients who might benefit from some of the newer treatments did not get them because insurers required high co-pays and special approvals. “The primary care doctors don’t know how to use them and if they do, they have to fight with insurers,” he said, “so they throw in the towel.”

Meanwhile, others might get too much intervention. Type 2 patients are often encouraged to use meters that measure blood sugar and other testing equipment. Ms. Neitling said that as soon as she received her diagnosis, she got “one or two meters” and more supplies than she ever needed — all of which were provided to her for free but billed to her insurer. At the Diabetes Expo in New York City in March, salespeople were signing up Type 2 patients to request a new meter — getting their name, their doctor’s name and an insurance card.

Two days later, Dr. Zonszein said, he faced piles of forms from companies asking him to prescribe a new device. Many, he said, were for patients who do not need close monitoring, or who already have two or three other meters at home.

There is no evidence that patients with Type 2 diabetes require daily home testing if they are not on insulin and are on stable doses of medicine, doctors say. While some physicians find that frequent testing can motivate some patients to be more attentive to diet and exercise, one study in Britain found that the main effect of intensive monitoring was simply added stress.

http://www.nytimes.com/

Graham