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Drug May Help Diabetics, But Carries Risks

RENEE MONTAGNE, host:

Most people with diabetes are overweight. Their cholesterol readings don't look good. Their blood sugar isn't under control. There is an experimental drug that some claim attack all these problems in one pill. Research supporting that claim has just been unveiled at the annual meeting of the American Diabetes Association in San Diego. NPR's Richard Knox reports on the study and on skeptics' reaction.

RICHARD KNOX reporting:

The drug is called Rimonabant. It's sort of a reverse form of marijuana; in fact, it owes its invention to marijuana. Some years ago, scientists discovered that human bodies actually make their own marijuanalike chemicals. These chemicals are called endocannabinoids. They make people hungry, a natural version of the munchies. Researchers discovered that overweight people have more endocannabinoids in their system, so they thought maybe a drug that blocks those chemicals might help people lose weight.

Dr. DOUGLAS GREENE (Sanofi-Aventis): There's never been a drug that has a profile like Rimonabant. It has effects in the brain and in the liver, in muscle and in fat tissue.

KNOX: Dr. Douglas Greene is with Sanofi-Aventis, a drug company that hopes to make a lot of money from Rimonabant. It just asked the Food and Drug Administration for permission to market it for weight loss, diabetes control and smoking cessation. Earlier studies showed Rimonabant helps overweight people shed some pounds and stop smoking. The new study is the first to show it works for diabetes. After one year, people with Type II diabetes taking Rimonabant lost 12 pounds vs. three pounds among those on a placebo pill. Their waistlines were an inch and a third smaller. Their blood sugar was a little better controlled. Their cholesterol and blood fats improved. And they were a little less likely to have a dangerous condition called metabolic syndrome. Earlier research suggests that to maintain these gains, people have to stay on Rimonabant indefinitely. Some researchers are excited. Dr. Louis Aronne heads the weight control clinic at Weill Cornell Medical College in New York.

Dr. LOUIS ARONNE (Weill Cornell Medical College): The big criticism of the types of treatments that I've been working on for 20 years has been: Are we getting at what's causing this problem? And the answer, frankly, has been no, but now the evidence is we are getting at the root cause of obesity when we're using Rimonabant. That's what the science is showing.

KNOX: Aronne has done company-sponsored research on Rimonabant. He says it's one of a half-dozen experimental drugs that work by blocking the body's natural marijuanalike chemicals.

Dr. ARONNE: The others are much further behind, but the point is that this mechanism is making a lot of sense to a lot of people based on the avalanche of research that's coming down the pike now.

KNOX: But not every obesity and diabetes expert thinks Rimonabant and its ilk are miracle pills.

Dr. TERRI MARATOS-FLIER (Beth Israel Deaconess Medical Center): At this point, I think it's an intriguing medication with possibilities, but not to the point where I would call it a miracle pill.

KNOX: Dr. Terri Maratos-Flier is an obesity specialist at Beth Israel Deaconess Medical Center in Boston. She calls Rimonabant modestly effective as a weight loss drug.

Dr. MARATOS-FLIER: My biggest concern is that people always lose weight better when they are in a study and they're being monitored and the 12-pound overall average weight loss is not overwhelming. I mean, you're talking about people who even at the end of the day are still overweight.

KNOX: Maratos said she'd be more impressed if patients on Rimonabant lost 24 pounds at the end of two years on the drug instead of 12 pounds after one year, but earlier studies indicate that people taking Rimonabant for two years merely maintain their first year weight loss. They don't continue to lose. Maratos also worries that 2 or 3 percent of people taking Rimonabant suffer depression and she points out that patient demand for a new weight loss drug will be enormous, especially if it's touted as doing other good things.

Dr. MARATOS-FLIER: So you have to balance the effectiveness of the drug with patient-induced demand in the community with the potential long-term side effects of the drug with the fact that even a study of a thousand or 2,000 patients for five years wouldn't tell you what's going to happen when the drug is released into the community and potentially there are 20 million people taking it.

KNOX: As recent experience with Vioxx and other drugs shows, sometimes a drug's true pluses and minuses emerge only after millions of people take it. Richard Knox, NPR News. Transcript provided by NPR, Copyright NPR.

Since he joined NPR in 2000, Knox has covered a broad range of issues and events in public health, medicine, and science. His reports can be heard on NPR's Morning Edition, All Things Considered, Weekend Edition, Talk of the Nation, and newscasts.