It promises to help patients lose five-to-ten percent of their weight (according to clinical trials) when combined with diet and exercise. But is this what America’s overweight patients really need?
Lorcaserin, the drug name for the prescription diet pill Belviq, was approved by the FDA today, making it the first weight loss drug to receive such approval since Orlistat (Alli) in 1999. This comes just weeks ahead of what is anticipated to be an FDA approval for Qnexa, another weight loss drug.
“In two clinical trials, Lorcaserin helped patients lose 5.8 percent of their body weight after a year. That’s about ten pounds for a 180 pound person. Big deal,” said our resident dietitian Mary Hartley, RD.
The drug works by controlling the appetite by making the brain think its fuller sooner. It’s fared well in clinical trials, and will have to undergo six more studies after its in market to ensure long-term cardiovascular health and to determine Belviq’s risk factor for heart attack and stroke. This makes the in-market patients unassuming guinea pigs, according to Hartley, and that isn’t right.
“The advisory committee decided that the benefits of the drug outweighed the risks heart value problems, but the drug manufacturer was made to conduct post-marketing studies to assess long-term cardiac events such as heart attack and stroke. That makes the patient a guinea pig. No thanks.”
Patrick O’Neil, president of the Obesity Society, was one of the investigators in three of the Lorcaserin studies, and he told USA Today that the drug approval is “a major step in the right direction.” He echoes our thoughts in that no pill is a substitute for proper nutrition and exercise. However, the risk for too many patients to use this as the Band-Aid on a bigger problem rather than addressing the root of their obesity is a concern that shouldn’t be ignored.
Following the FDA advisory panel approval of Lorcaserin in May, Michael Aziz, a internist at Lenox Hill Hospital said, “There is a need for a drug that can address the obesity issue. But we are really not covering the root of the problem, which is lifestyle changes and eating right. Many people are just looking for a quick fix.”
With few American doctors truly equipped to help patients with weight loss, this pill may be a tool in their arsenal but it’s certainly not going to give them any more ability to support their patients in a long-term way. It doesn’t seem anyone is stepping out to call this an obesity cure, thankfully, but instead a tool or medical aid that can support the nearly 40 percent of our country categorized as obese.
Lorcaserin didn’t gain its approval easily. It was rejected by the FDA just two years ago over concerns for its affect on heart valves. Patients using Belviq won’t be entirely in the clear. Sidney Wolfe, director at Public Citizen, told USA Today that the benefits of the drug are small, and that “practically everyone on the [FDA] advisory committee agreed that there wasn’t enough evidence to rule out clinically significant heart valve disease.” However, the FDA cited no “statistically significant difference” in heart valve risks in patients using Lorcaserin versus those using a placebo.
Currently Lorcaserin’s only competition at the pharmacy is Phentermine, a prescription appetite suppressant, and Orlistat, which is sold as higher-dose prescription drug Xenical and over-the-counter as Alli. Qnexa’s approval is only weeks away, and that’s going to be a game changer according to Tim Church, director of preventive medicine research at the Pennington Biomedical Research Center.
He notes that more diet pills on the market will cause the country to start treating obesity like a disease, which is a good thing, unless you’ve got unequipped doctors providing the treatment. More weight loss drugs should come more weight loss training for physicians to ensure we’re not putting on patches on severely broken pipes.
“I have seen hundreds of people lose weight and maintain without taking diet pills. Diet pills benefit drug makers and doctors who feel helpless in the face of unrelenting obesity, but they don’t help patients in the long run,” said Hartley. “In fact, diet pills give patients an excuse to relinquish their locus of control, which is too bad because an internal locus of control makes all the difference in maintenance.”
June 27th, 2012