Despite the disastrous outcomes of some diet drugs — including Redux (aka Fen-Phen) in 1996 and Meridia (Sibutramine) in 2003, the pharmaceutical industry keeps trying to find a safe, effective medication that will help the 160 million Americans considered obese or overweight lose weight. In the past 3 years, 5 drugs have been approved for treatment of chronic obesity, including 3 in 2014. A slew of other medications have surfaced to treat type 2 diabetes, an obesity-associated condition, while Vyvanse, designed to help those with binge-eating disorder, received FDA approval in early 2015.
New surgical approaches, implantable devices, commercial stomach pumps and even gel pills that expand when ingested have also come to market to compete in the war against obesity.
The Latest Obesity DrugsWhich of these treatment strategies are effective, what are their side effects and what other factors should be considered when choosing an intervention? This guide will provide answers to those questions.
Each of the latest drugs approved by the FDA attacks excess weight gain in a different way. Belviq increases the brain’s uptake of the “happy” hormone serotonin to suppress appetite, while newcomer Saxenda mimics an intestinal hormone that tells the brain the stomach is full. Contrave is a combination of two FDA-approved drugs, naltrexone and bupropion, and sold in an extended-release formulation. Naltrexone is designed to treat alcohol and opioid dependence while bupropion is used to treat depression, seasonal affective disorder and as an aid for smoking cessation. None of the drugs appear to be a miracle breakthrough, however. Nor are any recommended without a rigorous diet and exercise program. And, as our chart shows, they all carry a distressing number of side effects.
According to a recent report by AdverseEvents, an independent organization that monitors the safety and side effects of drugs after they’ve been on the market, Qysmia may have a safer drug profile than Saxenda, which comes with a black-box warning that notes the potential risk of medullary thyroid carcinoma and of acute pancreatitis. “Though both Saxenda and Qsymia labels contain long lists of adverse events (AEs) (112 and 130, respectively), it initially appears that Qsymia may display a safer side effect profile as the active ingredient of Saxenda is associated with serious pancreatitis and cancer risks,” notes AdverseEvents’ report on obesity drugs (available by subscription only). Because it contains bupropion, the new drug Contrave also has a boxed warning noting the possibility of increased risk of suicidal thoughts and behaviors associated with antidepressant drugs. The warning also points out that serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation. Contrave has also been shown to cause seizures in some patients.
Treating Obesity as a Disease
After decades of research, why is there a dearth of effective diet drugs? Nikhil Dhurandhar, MD, chair of the department of nutritional sciences at Texas Tech University in Lubbock and the president of the Obesity Society, says that until recently obesity was thought of as purely a behavioral problem.
“The prevailing view is that obesity can be cured by pushing one’s self away from the table, but that view exhibits a lack of deeper understanding of the science of obesity medicine today,” he says. “It now seems clear that we need to treat this problem in the same way we treat other chronic health issues,” such as diabetes, heart disease and arthritis. And, while the current choices aren’t perfect, he believes they are an essential supplement to behavior change.
“The benefits outweigh the risks,” he said. “I also think we will begin to see better results overall, as additional drugs are approved.”
With more than 2/3 of Americans now considered either obese, defined as having a body mass index (BMI) greater than 30, or overweight (a BMI between 25 and 30), it’s clear that safe, effective obesity treatments are desperately needed. Dr. Dhurandhar says that with the American Medical Association’s declaration in 2013 that obesity is a disease, consumers should begin to have better access to all sorts of weight-loss therapies, including medications, surgery and implantable devices.
An interesting side note to the obesity story: While the majority of obese people develop chronic health problems like high blood pressure, high cholesterol and diabetes, a small minority manage to escape these ills according to recent research. A Finnish study of twins found that a percentage of the heavy twins fell into a category called “metabolically healthy obese,” because they did not develop the chronic conditions associated with excess weight. According to a recent New York Times article on the study, researchers found that the fat tissue in this healthy obese group remained in the padding just beneath the skin rather than accumulating in the liver, where it could become problematic. As the article points out, it’s not clear how long this protective tendency lasts.
However, metabolic health is only one concern for someone who carries too much weight. Frank Hu, MD, professor of nutrition and epidemiology at the Harvard School of Public Health, also wrote about the “metabolically healthy obesity” in Lancet Diabetes and Endocrinology. He points out the connection between obesity and a range of other health issues such as several cancers, joint problems and sleep apnea. Losing weight should be a goal for the metabolically healthy obese as well, he noted.
Of course, medication isn’t the only approach to tackling obesity and several new non-drug options have come to market. Briefly, here is an overview on the most popular weight loss tactics used today — and what’s in store for the future.
Devices and Implants
The MAESTRO system is an implantable device, akin to a pacemaker, that blocks the vagus nerve, which normally provides information about how hungry or full you are. Another new option is more of a cross between a pill and a device: Gelesis100 is a capsule filled with particles that expand in the stomach, mixing with consumed food and slowing digestion.
Over-the-Counter Diet Drugs
Over-the-counter diet pills have an even worse track record than prescription drugs. To begin with, most people take them without medical advice and may not realize the dangers of mixing them with other drugs and supplements. Secondly, many of the products, particularly herbal supplements, are largely unregulated so there’s no telling what’s actually in them. In February 2015, the New York State attorney general’s office accused four major supplement retailers of selling fraudulent and potentially dangerous herbal supplements and demanded that they remove the products from their shelves. Many of the products the office tested didn’t contain the active ingredients listed on the label. Others tested positive for allergens and other hazardous materials not included on the label.
Even assuming an accurate ingredients list, there’s very little proof that these supplements, powders and potions do any good. The diet pills, powders and potions sold today, whether they are sold online, in health food stores or at the neighborhood pharmacy, are an expensive way to lighten up your wallet without shrinking your waistline, according to the majority of health experts.
Diet and Exercise
The often quoted statistic that more than 95% of dieters fail is based on a study done in 1959 where 95 out of 100 dieters failed to follow through on their diet regimen and did not lose weight. Since then, little has been done to substantiate the findings. It’s impossible to know how many dieters actually do succeed in their quest to shed unwanted pounds. Safe to say, not many. This is true whether the diet is prescribed by a doctor or involves restricting your meals to grapefruit and cabbage soup.
The evidence for exercise’s impact on weight loss is even less clear and often conflicting. A team of British cardiologists writing in a recent issue of the British Medical Journal made the claim that, while exercise is important for health, it won’t help with weight loss. “You can’t outrun a bad diet,” they wrote, adding that the emphasis should be on cutting calories and making healthier food choices.
However, not all experts agree with this assertion. Numerous studies demonstrate the power of exercise, particularly high intensity exercise, for weight loss. Even without a drop in the number on the scale, exercise may build muscle and decrease fat, leading to a more favorable body composition and BMI. Perhaps more importantly, there is a growing body of evidence to suggest exercise is one of the most important habits for maintaining weight loss. The National Weight Control Registry, which tracks people who have lost 60 pounds and kept it off for at least two years, reports that nearly 90% of registrants burn at least 2,000 calories a week through exercise, to prevent weight regain.
Even if a diet and exercise plan doesn’t help you drop all the weight, the science is clear: Sensible lifestyle habits are good for your health. It’s also one of the few weight loss interventions that mitigate many of the health issues associated with obesity with virtually no negative side effects.
There are several different types of weight loss (or bariatric) surgeries available today. Ideal candidates for surgery have a BMI over 40 or between 35 – 39.5 with serious health complications such as diabetes or heart disease.
Gastric bypass, which accounts for more than 50% of the 200,000 weight loss surgeries performed in the U.S. each year, involves cutting the stomach into smaller pouches, then rerouting the digestive tract. Lap-Band is performed laparoscopically, meaning the surgeon makes a few small incisions in the abdomen, then uses long, thin surgical instruments to encircle the stomach with a silicone and titanium band. The third type of surgery, gastric sleeve, involves removing about 80 percent of the stomach. Besides shrinking the amount of food the stomach can hold, these surgeries minimize calorie absorption and seem to regulate gut bacteria and hunger hormones.
Compared to all other weight-loss methods, surgery boasts the highest weight-loss success rate. On average, 85% of gastric bypass patients lose at least 65% of their goal weight loss and keep at least 50% off for a year, according to Columbia University statistics. On the other end of the spectrum, studies show Lap-Band patients lose an average of 35% of their excess weight. This type of surgery also carries the most complications and highest failure rates.
While more effective than most other weight loss methods, all the surgeries carry a high risk of side effects and serious complications. Studies estimate that approximately 50% of women and 30% of men who undergo weight loss surgery experience complications. Nearly half of patients who have laparoscopic gastric banding for obesity eventually need to have the devices removed because of erosion or some other malfunction, researchers say. Nausea, vomiting and diarrhea are other common post-surgery complaints, and more than a third of patients develop gallstones. About 20% of weight-loss surgery patients require further procedures for complications, with as many as 30% reporting complications due to malnutrition because most surgeries result in malabsorption of nutrients due to reduced calorie absorption.
Death as a direct result of surgery is rare but some side effects can be serious. For example, a condition known as Noninsulinoma Pancreatogenous Hypoglycemia Syndrome (NIPHS) results in extremely low blood sugar levels. This can cause neurologic symptoms like confusion or even seizures and require emergency surgery.
What the Future Holds
No existing weight loss method is considered a magic bullet. Perhaps that’s why researchers have gotten creative. A recent American Society for Metabolic and Bariatric Surgery listed an experimental treatment for stunning the stomach and intestinal lining with the cosmetic drug Botox (prepared from the bacterial toxin botulin) to reduce hunger pangs and another for chemically scarring the intestine to slow digestion. Neither method has quite panned out as hoped.
More promising: A method called the intragastric balloon, a device that’s inserted into the stomach and inflated so there is less room for food. Initial studies have been promising especially because the biggest risk seems to be the balloon deflating. The first U.S. trials for this device are currently underway in Philadelphia; patients in the trial will swallow a series of pills that will inflate in their stomachs which will be removed after six months. If successful, this method moves one step closer to FDA approval. In European trials, this method resulted in an average 15% weight loss.
Another method known as the AspireAssist pump is already being used in Europe. It works by sucking about 30% of the food eaten right out of the stomach. Patients wait 20 minutes after eating, then empty their stomach contents into the toilet through a small, handheld device that connects to a skin-port discretely embedded on the outside of the abdomen. Gross? Absolutely. But in a one-year trial of 24 obese patients, patients, on average, lost 49 percent of excess weight, the equivalent of about 45 pounds.
Aspire Bariatrics, the pump’s maker, says the most likely complications are abdominal discomfort and constipation/diarrhea. Other less likely risks include infection, anemia and buried bumper syndrome, which can generally be resolved with conservative medical care or tube replacement. The FDA has yet to approve this machine.
Dr. Dhurandhar says less invasive weight loss procedures that carry fewer risks and side effects are coming along but may not be quite as effective as current surgical interventions. He also thinks diet drugs will get better and safer as more pharmaceuticals enter the marketplace. For example, he’s seeing some residual weight loss in patients treated with medication to manage diabetes, one of his areas of study. Many of these medications are being considered for use in obesity treatment, he said.
For More Information
- Weight loss surgery: do the benefits really outweigh the risks? (Medical News Today)
- Why Does Gastric Bypass Surgery Work? (Science Magazine)
- The 6 Weight-Loss Tips That Science Actually Knows Work (Forbes)
- Dieting vs. Exercise for Weight Loss (New York Times)
- Two new diet drugs can boost weight loss by 5% to 10% (USA Today)
- F.D.A. Approves Qsymia, a Weight-Loss Drug (New York Times)
- Contrave makes the grade while Saxenda receives a strong endorsement (Data Monitor Healthcare.com)
- Are Over-the-Counter Diet Pills Safe? (Everyday Health)