During an insomnia jag a few years ago, I caught a late night infomercial for Exercise In A Bottle. Essentially you take the pill and it has all the benefits of exercise, including weight loss. My first thought is: I can’t believe they are hiding this game-changing uber-revolution in 3am programming! They even got Steve Garvey, former professional baseball player and MVP to be pitchman. (Dear Steve: Really?) In a *shocking* twist of events, the FTC banned the company from marketing the product due to false claims and forced them to pay $300K in consumer redress. The FCC even sued Steve for false claims. Apparently he was caught exercising in a real gym.
Ahhh.. the magic pill. The one that will prevent us all from having to put so much effort into exercise, trying to eat right, and all those hard things that we don’t want to do. Pop the pill and the pounds will fall off. The bad news is: THAT pill is not coming. The good news is that some other agents are on the horizon that could be used as a weight loss aid to your efforts to exercise and consume a healthy diet. One thing to keep in mind is that virtually every weight loss medication study out there looks at the impact of the medication when combined with a dietary and physical activity intervention. No drug is meant to be used as an alternative to living a healthy lifestyle, but rather in addition to a healthy lifestyle.
Weight loss drugs have had a checkered past to say the least. They have fallen from grace more often than slick politicians and professional athletes (I can say this now, Steve logged off two paragraphs ago). Remember the days of Fen-Phen (fenfluramine and phentermine)? The drug combination was an effective weight loss agent but resulted in sometimes deadly cases of pulmonary hypertension and heart valve problems, and ultimately multi-billions of dollars in lawsuits. The bar has since been raised with drugs getting pulled off the market a bit faster. The most recent examples include Meridia (aka sibutramine) which the manufacturer pulled the plug on last year (just as the FDA was about to) for increasing risk for cardiovascular events and strokes. Last year, the FDA also rejected Qnexa, and Locaserin, two of the most studied agents. Side effect profiles were just too risky.
The only FDA-approved drug for weight loss on the market was orlistat and even it got pulled in the last year (you might recognize by the name of Ally). Other agents are on the horizon, but still in the various phases of safety and efficacy testing. The closest thing to hopeful right now is a drug called Contrave, which is a combination of bupropion, an antidepressant medication, and naltrexone, an opioid receptor antagonist that is often used in the treatment of alcoholism. Both of these agents are independently FDA-approved and in use for other indications, but the combination has not been approved just yet. The average weight losses reported in trials is about 11-14 pounds and about 25-30% of patients will lose 10% of their weight. Possible side effects include increase in blood pressure and heart rate. The FDA considered but then rejected Contrave in February pending further safety data.
A little further down the pipeline are Empatic, a combination of bupropion and zonisamide (an anticonvulsant often used to treat epilepsy or schizophrenia) and tesofensine, a serotonin-norepinephrine-dopamine reuptake inhibitor, both of which just emerged from phase 2 trials. In trials, Empatic was associated with average weight losses of about 11-14 pounds. Tesofensine was associated with average weight losses of 14-28 pounds depending on dose–not too shabby. However, the higher doses appear to be associated with greater side effects including increased heart rate, which may threaten approval at those doses. Additional data are needed to more firmly establish safety and efficacy. The FDA isn’t likely to weigh in until those data are available.
At the end of the day, it doesn’t look like there is a magic pill and no super magical ones on the horizon. Maybe the real magic is not in a pill, but somewhere else. Maybe it’s in the sunrise after mile 2 on the trail, maybe it’s in the rosy cheeks of your son after an hour of kicking the soccer ball around together in the backyard, maybe it’s in the silence of a snowfall on your first time out cross country skiing, or maybe it’s at the finish line of your first 5K…
If you are looking for magic, don’t wait for the drug companies or the FDA, it’s all around you…
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