A new diet pill hyped as revolutionary by researchers is winning rave reviews in the European Union since its approval last June. But here at home, Americans, obese and otherwise, can only wait as the Food and Drug Administration drags its feet on the fat-fighting phenom's overdue OK.
Recently, irate consumers in the States started taking the law into their own hands by purchasing rimonabant—brand name Acomplia—over the Internet from British pharmacies, according to the Acomplia Report (www.acompliareport.com), an independent Web site devoted to the drug. Last week, the feds nabbed their first weight-watching criminal.
No diet med has enjoyed this degree of "wonder drug" hype in a generation, and if Acomplia delivers on its promises, not only will it be a boon for the unprecedented epidemic of obesity from which more than half of America suffers but it will also be a multibillion-dollar blockbuster for Sanofi, its maker. Obesity is a condition characterized by the storage of excess fat—typically 30 percent or more—in the body.
Why all the buzz? Acomplia works in a revolutionary way, controlling appetite by blocking pleasure centers in the brain that stimulate food cravings. (Researchers are also investigating its use as an anti-smoking agent.) By reducing both the pleasure you get from eating and the hunger pangs associated with dieting, Acomplia proved significantly effective in a large clinical trial in helping people shed pounds—and, more important, keep them off—for two years. The Acomplia munchers lost an average of 19 pounds, compared with a five-pound weight loss for those on the dummy pill.
That's not all—Acomplia may also boast a second key health plus: It appears to increase good HDL cholesterol and improve insulin efficiency, lowering your risk for heart disease and diabetes.
Still, skeptics point out that the patients in the trials were also enrolled in exercise and nutrition regimes. These lifestyle improvement alone could help many overweight Americans get fitter and feel better. Plus, you have to keep the Acomplia coming to keep the weight from coming back. And, like many drugs, Acomplia is accompanied by a list of unwanted side effects. In addition to the usual complications—such as dizziness, nausea, diarrhea and headache—there are troubling reports that the weight-loss wonder may cause depression. Whether this is related to its zapping of the brain's happy zones remains to be seen.
The price set by Sanofi is also a problem. Even the frugal Brits are having to shed many pounds of silver to shed a few pounds of fat, with the drug's price tag at more than $100 (U.S.) a month. Americans can expect the company to jack up the price a possible 50% when it finally reaches our unregulated shores. But this week, Aetna became the first big insurer to give a provisional thumbs-up for prescription coverage.
But with the FDA still reeling from its complicity in a series of drug-safety scandals, including the pain-killer Vioxx and the diet pill Fen Phen, experts predict that Acomplia won't hit the United States for another year. What's an American to do? Do you take your chances by e-smuggling, or just get on that treadmill and run?