Diabetics See Hope (and Weight Loss) in New Drug

By Alex Berenson

The users call the drug Lizzie, the Big Brother or sometimes Gilly. On blogs they rave over its uncanny ability to melt away pounds, although some are wary of its side effects, which can include nausea and strange welts.

The users are not fad dieters or methamphetamine addicts, but people with diabetes. And the subject of their rhapsodies is not a gray-market diet pill sold on late-night television but Byetta, a medicine approved by U.S. regulators that is available only by prescription and whose popularity and sales have soared since its introduction last June.

For diabetics, the weight loss caused by Byetta comes as a welcome contrast to the weight gain that often accompanies insulin and other diabetes medicines; the extra pounds can eventually worsen the disease. Some patients say Byetta has reversed the course of a disease that can lead to severe complications like amputations, blindness and kidney failure and even death.

“I went from despair to life no hope to lots of hope,” said John Dodson, a 73-year-old pastor in Felton, California. Dodson, who is 5 feet 6 inches, or 1.68 meters, tall, says he has lost almost 60 pounds, or 27 kilograms, since starting Byetta last June. He now weighs 178 pounds, his lowest weight since college.

The drug seems so effective for weight loss that some nondiabetic people have begun using Byetta as a diet drug, causing concern among doctors who say such use has not been medically tested and could be dangerous.

But for diabetics, weight loss from Byetta could be a particularly important benefit. Among the 21 million Americans with diabetes, about 90 percent have Type 2, which usually occurs in adulthood and has been linked to obesity and inactivity.

Byetta is not a cure-all, doctors caution. Some patients cannot tolerate its side effects. And it has never been studied as a weight- loss agent in people with normal blood sugar. Amylin Pharmaceuticals and Eli Lilly, which jointly make and market Byetta, said they strongly discouraged its use solely as a diet drug. Based on testing in rats, moreover, some scientists have raised the possibility that Byetta may increase the risk of thyroid cancer, although no evidence of that link has appeared in human clinical trials.

Still, diabetic patients are embracing the drug, despite the requirement that Byetta must be kept refrigerated and injected twice daily, making it less convenient than drugs taken in pill form. Users’ enthusiasm is all the more remarkable considering that Amylin and Eli Lilly do not plan to advertise Byetta to consumers until at least this summer, a year after its introduction, in keeping with voluntary advertising guidelines that the drug industry adopted last year.

Even without a major marketing push, Byetta prescriptions are soaring, as news spreads among diabetics and doctors. From November to January, monthly prescriptions for Byetta rose almost 40 percent, to almost 100,000, well ahead of analysts’ forecasts. Byetta costs about $170 a month, or $2,100 a year, slightly more than most other diabetes drugs, but most insurers do not cover it.

Byetta’s active ingredient is a protein, exenatide, that encourages digestion and the production of insulin. The fact that exenatide was initially discovered in the saliva of the Gila monster, a poisonous lizard found in the U.S. Southwest, explains the nicknames Lizzy and Gilly for Byetta. The third nickname, Big Brother, refers to the 10 microgram dose of Byetta, which patients say is more likely to cause nausea than the smaller 5 microgram dose.

The weight loss reports raise the question of how widely Byetta will be prescribed as a diet drug to people who are not diabetic a so-called off-label use. Doctors can legally do so, but the Federal Drug Administration and the makers say the drug is supposed to be prescribed only to people with diabetes whose blood sugar is too high even though they are taking other diabetes medicines. Amylin and Eli Lilly say people who are not diabetic should not take Byetta. The companies say they have no plans to study Byetta as a weight-loss treatment in people with normal blood sugar.

Many doctors also say Byetta is probably inappropriate as a weight-loss drug. But despite the cautions and drawbacks, some doctors do appear to be prescribing Byetta primarily as a weight- loss aid in people who do not have elevated blood sugar. Many patients appear more than happy to inject themselves twice a day and endure upset stomachs and nausea, the most serious side effect, as long as they can keep losing weight.

“Initially, I really had quite a bit of nausea,” said Karen Brady, 51, a computer programmer in Houston. But Brady said she had stayed with Byetta and lost 50 pounds in the past five months. At 5 feet 5 inches, she now weighs 150 pounds.

The drug does not permit her to overeat, she said. “What you eat stays in your stomach forever, so if you do overeat, you’re going to be in for a really unpleasant time,” she said. “I’ve only done it once, but it was a good teacher. It keeps me honest.”