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A Pill To Burn Away Pounds: The FDA Says Yes To The First New Weight Loss Drug In 13 Years

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Today marks the arrival of the first new diet drug in 13 years, with the Food and Drug Administration's approval to market lorcaserin. (Not to be confused with Qnexa, another new diet drug, which is still awaiting FDA approval as more studies are submitted.) The last time the FDA gave the stamp of approval to a new weight loss drug, it was orlistat (brand name Xenical) in 1999.

Once it's fully vetted by the Drug Enforcement Administration, lorcaserin will be marketed in the United States under the commercial name Belviq.

Impressive numbers indeed

In one Phase III clinical trial for lorcaserin, known as Blossom, 47.5% of patients lost at least 5% of their body weight, compared to 20.3% for placebo. Additionally, 22.6% of lorcaserin patients lost at least 10% of their body weight, compared to 7.7% for placebo. Lorcaserin patients achieved an average weight loss of 5.8% of their body weight, or 12.7 pounds, compared to 2.2%, or 4.7 pounds, for placebo. In a second trial, known as Bloom, 47.2% of lorcaserin patients lost at least 5% of their body weight, compared to 25.0% for placebo.

Who needs Lorcaserin/Belviq - and who stands to profit?

Well, the market for lorcaserin could include more than one out of every three Americans, according to the FDA's calculations. The agency approved the drug  for those who are obese, meaning their body mass index (BMI) is over 30, or for those with a BMI of 27 who also have another risk factor like high blood pressure, high cholesterol, or diabetes.

Since one out of every three Americans is obese, and another third are overweight (and likely to have at least one of the other risk factors that go with excess weight), that could qualify close to two thirds of Americans for the new drug. That's big news for ARNA, a division of Arena Pharmaceuticals, maker of lorcaserin. And also for Vivus, maker of Qnexa, which is likely to get a bump in confidence from the FDA's action.

Health Dangers: A Game of Risk vs. Benefit?

Since lorcaserin appears to be very effective, its benefits for those who are obese or overweight are pretty clear. There is some question about whether lorcaserin carries at least some heart disease risk, similar to that likely to be caused by Qnexa, another new diet drug expected to win FDA approval within months. Qnexa was sent back for additional studies because of concerns about heart valve damage, a permanent and life-threatening side effect.

As  soon as news hit that the FDA was giving lorcaserin a thumbs up, the consumer watchdog group Public Citizen launched a campaign of protest, raising issues about valve damage.

It's not that simple, though, since obesity is also life-threatening when you consider all the diseases and conditions, from diabetes to heart and lung disease, that come along with being seriously overweight. The last time I wrote about this subject for Forbes, I heard loudly and angrily from obesity groups, who herald the arrival of any new weight loss drug as life-saving news for those who feel they have no other recourse to lose weight. However, I continue to believe in the research  -- including convincing long-term analysis by the National Weight Control Registry -- that says careful adherence to a low-calorie diet and consistent exercise plan is the safest, healthiest, and most effective way to lose weight and keep it off.

Thoughts? Would you take a diet pill that carried health risks if it promised weight loss with little unpleasant lifestyle change?  And on the other hand, if you've lost a considerable amount of weight and kept it off, what worked for you?