FDA approves new diet pill
The Food and Drug Administration has officially greenlit Contrave, a new drug that targets obesity and only one of three such medications to be approved by the organization in the past decade.1 The two other obesity pills, Qsymia and Belviq, were both approved by the FDA in 2012. Both of these medications were expected to have blockbuster sales, as obesity affects one in three people in the United States, but the response to the drugs has been relatively mild. Perhaps this is because obesity is a very complex issue for medical professionals, insurance companies and the industry of pharmacy technology.
Obesity can lead to problems such as cardiovascular disease, diabetes and some types of cancer. Without extensive supportive evidence that the pills can reduce these risks long term, many insurance providers are wary to include them as part of medical coverage. In fact, obesity coverage is only included by approximately 30 to 40 percent of health insurance providers.1 This issue becomes more convoluted when diet and exercise are also taken into consideration.
A balanced diet and regular exercise are the cornerstones of lifelong health, especially in regard to maintaining a healthy body mass index. Qsymia, Belviq and Contrave, while all considered helpful in mitigating obesity, ultimately still require patients to regularly practice these other two facets of healthy living. Therefore, any patient who inconsistently takes the medication and doesn’t adhere to eating healthy and exercising practices will likely not benefit from the pills.
These stipulations make it difficult for many insurance providers to double down on obesity meds, but their seeming indifference also undermines the seriousness of the obesity epidemic in the U.S. Whether the new drug will be embraced more widely than its competitors is yet to be seen. However, Contrave garnering FDA approval is certainly the first important step toward the drug becoming an important part of fighting obesity.
Obesity in the US
According to the U.S. Centers for Disease Control and Prevention, approximately 78.6 percent of Americans are considered obese.2 In 2008 alone, the cost of obesity in the country was around $147 billion.2
Obesity is defined by BMI. Any adult with a BMI of 30 or higher is considered obese, and those with a BMI greater than 25 are considered overweight.3 Anyone with a BMI of 40 or higher are considered extremely obese, a condition which drastically increases one’s risk of suffering from health problems such as heart disease. Obesity has become an epidemic in the U.S., and can be caused by inactivity, unhealthy eating habits, lack of sleep or certain medications.3
Medical professionals, tech firms and pharmaceutical companies have all been developing preventative measures and treatment options for obesity as it continues to be a growing problem. If pill producers hope testing will prove their products bring about results, it is likely drugs such as Contrave will become popular options for trying to lose weight. Medical practices, such as the Mayo Clinic, along with tech companies, are taking a more preventative approach by creating real-time health monitoring devices. The hope for these wearables, such as the new Apple Watch, is to put people more in control of dieting and exercising by allowing them to make note of these functions throughout the day.
Contrave is a chronic weight management drug to be used in addition to a healthy lifestyle.4 It is a combination of two drugs the FDA has previously approved separately, naltrexone and bupropion. The former is a drug often prescribed to treat alcohol and opioid addiction, while the latter is an antidepressant. Contrave underwent multiple clinical trials consisting of a total of about 4,500 obese people. All patients in the trials were put on a reduced calorie diet and mandated to regularly exercise.
“Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.1 percent over treatment with placebo (inactive pill) at one year,” the FDA explained in a press release. “In this trial, 42 percent of patients treated with Contrave lost at least 5 percent of their body weight compared with 17 percent of patients treated with placebo.”
For a patient to be prescribed Contrave, he or she must have a BMI of 27 or greater and also have at least one weight-related condition. Therefore, Contrave is not a diet pill. The drug also must undergo additional clinical trials and studies as stipulated by the FDA.
Since Contrave contains an antidepressant, the drug has to include an FDA warning regarding the potential risk of increased suicidal thoughts and other side effects associated with antidepressants.4
Of course, while advancements in pharmacy technology potentially can help quash the growing problem of obesity, there is nothing that replaces diet and exercise. Medical professionals have a responsibility to help instill healthy habits in their patients to help fight this epidemic.
1“Long-awaited diet pill gets U.S. approval” by Natalie Grover. Reuters. September 11, 2014. http://www.reuters.com/article/2014/09/11/us-usa-obesity-orexigen-idUSKBN0H61EU20140911
2“Adult Obesity Facts” U.S. Centers for Disease Prevention and Control. September 9, 2014. http://www.cdc.gov/obesity/data/adult.html
3“Obesity” by Mayo Clinic Staff. Mayo Clinic. May 13, 2014. http://www.mayoclinic.org/diseases-conditions/obesity/basics/risk-factors/con-20014834
4“FDA approves weight-management drug Contrave” News release. FDA. September 10, 2014. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm413896.htm