New Anti-Obesity Drug Enters Market, But Roadblocks to Treatment Remain

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As the fight against obesity in America continues to ramp up, experts have been busily attacking the problem from all sides: with guidelines on nutrition and exercise, psychological insights, surgical advances, and a small but growing array of medications. Now there’s one more option in the arsenal of anti-obesity drugs, Contrave, which received approval from the FDA on Wednesday after a long review process. (Another, liraglutide from Novo Nordisk, already approved to treat diabetes, was deemed safe by the FDA on Thursday, and could also be on its way to FDA approval.) Contrave’s approval has generally been met with excitement from physicians who treat obese patients. But it remains to be seen how well it does in the marketplace, as sales of the few other FDA-approved anti-obesity drugs have been lackluster — something experts attribute to a variety of factors, including stigma.

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“We have to recognize that obesity is probably the most stigmatized condition that we have,” Ethan Lazarus, a Colorado obesity-medicine physician and a trustee with the American Society of Bariatric Physicians, told Yahoo Health. That can make patients reluctant to seek medical treatment, just as it can lead some doctors to blame patients for their condition — despite the fact that the American Medical Association began officially recognizing obesity as a disease in 2013, he said.

“Even though the AMA recognizes something as a disease doesn’t mean we all of a sudden have doctors trained in it,” Lazarus noted. He likened the country’s current view of obesity and its need for treatment to that of “depression back in the 1980s,” and said it would take some time to change attitudes.

Contrave, approved by the FDA “for chronic weight management in addition to a reduced-calorie diet and physical activity,” is meant for use in obese adults with a body mass index (BMI) of 30 or greater — as well as for adults with a BMI of 27 or greater who have at least one weight-related condition such as high blood pressure or type 2 diabetes. It’s in a different class from the handful of other available anti-obesity drugs, which include five other options such as Qsymia and Belviq, because it works in a different part of the brain, Lazarus explained. In addition to affecting the hypothalamus, as the others do, it works in the mesolimbic pathway, also known as the reward pathway. “That’s important,” he explained, “because a lot of people eat out of a sense of rewarding themselves. This turns down that reward system.” He called approval of the drug “awesome,” and said it “gives us a totally new mechanism of treatment.”

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The Obesity Society, a professional organization dedicated to research and education, concurred, releasing a statement that called the approval “an important step,” that adds to the “important tools in the clinician’s toolbox for treating obesity.”

As Deborah Bade Horn, a weight-loss expert at the University of Texas Health Science Center at Houston, told Yahoo Health, “Contrave targets the addictive-like nature of eating —some patients have that, some don’t. Obesity is a multifactorial disease that affects all people in different ways. So it’s important to have many pathways that we can target.” It would also be effective in combating one of the biggest struggles of those fighting obesity, which is trying not to regain the weight once it’s lost, and can often provide a good option over surgery, experts say. But, added Bade Horn, who is the vice president of the American Society for Bariatric Physicians, “not everybody has accepted that obesity is a chronic disease and that it requires chronic disease management.” And that, she said, has lead to a medication hurdle even bigger than that of stigma: cost.

Anti-obesity medications can cost up to $200 a month and usually are not covered by insurers. And that, combined with the relatively low efficacy of the drugs — boosting weight loss in most cases by just five to 10 percent — can make opting for drug treatment simply not worth it for many.

“The Centers for Medicaid and Medicare Services has an exclusion for these types of drugs, and that’s the biggest thing that needs to change,” Bade Horn explained, “because private carriers tend to follow closely what CMS does, although some are moving toward the coverage, and that’s a lovely sign.” The Affordable Care Act, she added, also does not cover anti-obesity medications.

There’s still a third strike against these drugs, which is the list of the serious possible side effects. “I worry most about seizures and suicidal thoughts,” Lazarus said, noting just two of the risks associated with Contrave. The risk of suicidal thoughts, noted the FDA, is because the drug contains buproprion, an antidepressant, which would signal physicians to use particular cautions when prescribing. It also contains naltrexone, which has been used to treat drug and alcohol dependence. Other listed possible side effects include raised blood pressure and increased heart rate, as well as less significant issues such as nausea, headache, and dry mouth. Qsymia comes with risks that include depression and confusion, while Belviq has been associated with hypoglycemia, hallucinations, depression, painful erections, and a slow heartbeat.

“We’re up against a long history of risky obesity drugs. Fen-Phen definitely set us back,” Lazarus said, referring to the 1999 class-action lawsuit against makers of the weight-loss drug, dubbed a “miracle pill,” that wound up being linked to deadly heart-valve damage. “There’s a high level of scrutiny now because of concerns over heart safety.” Hopefully, he noted, the increased oversight will be worth it, bringing more and more safe treatment options to patients facing very worrisome statistics: Globally, around 3.4 million people die every year as a result of obesity. “Having a new medication available will give people one more piece of hope,” Lazarus said.