Source: Flickr user Next Twentyeight.
Cancer is arguably the disease that garners the most global attention due to the swiftness with which it can kill, but in terms of sheer numbers there may not be a more serious disease than obesity.
Obesity: a more serious threat than you probably realize
Known as the "silent killer," obesity comes with a veritable laundry list of risk factors, which include a higher risk for type 2 diabetes, hypertension, high cholesterol, and coronary artery disease, to name a few. To be clear, being obese doesn't mean you'll develop these conditions, but the data suggests that if you are obese, your chances of developing one or more of these conditions is magnified.
However, obesity is far from being just a personal concern -- it's a global dilemma. Since 1980, per the World Health Organization, the number of obese or overweight people has jumped 28% among adults and 47% among children globally. In 2013, 33 years after its initial study, WHO claimed there were 2.1 billion overweight or obese people worldwide.
Furthermore, a report released last year from the McKinsey Global Institute estimated that obesity was costing the global economy $2 trillion per year. To put that into perspective, obesity's global cost is 54% higher than illiteracy, 43% more than alcoholism, and just an estimated $100 billion behind smoking and armed violence, war, and terrorism. As the report noted, obesity is now responsible for 5% of all deaths worldwide.
It's obesity statistics like these that have inspired the U.S. government, state and local agencies, as well as many businesses, to take a strong stance against obesity in the hope of preventing the numbers from rising even further. Over the past decade we've witnessed fast food restaurants, which are typically harbingers of fattening food, introduce salads, we've observed a greater emphasis in schools in keeping kids active, and overall we've seen education surrounding the potential dangers of obesity come to the forefront.
And still, it would appear that obesity statistics are heading in the wrong direction.
Source: Centers for Disease Control and Prevention.
Obesity statistics take a wrong turn
A fresh study released this week from researchers at the Washington School of Medicine, and published online in JAMA Internal Medicine, showed that obesity rates among men and women have skyrocketed over an approximate two-decade timespan, which is consistent with the data that the Centers for Disease Control and Prevention has put forth.
After analyzing 15,208 men and women aged 25 and older between 2007 and 2012 from the National Health and Nutrition Examination Survey, Washington University School of Medicine's data showed that almost three-quarters of men and 67% of women are considered obese or overweight based on a body mass index reading. A BMI above 25 and below 30 is considered overweight, while 30-plus would represent being obese per the BMI scale.
By comparison, a similar study was conducted using data between 1988 and 1994 and "just" 63% of men and 55% of women were considered to be overweight or obese at that time.
As study author Lin Yang opined,
"We see this [data] as a wake-up call to implement policies and practices designed to combat overweight and obesity, to implement what we already know into place to accelerate the obesity prevention and treatment."
Could these solutions come into play?
Ultimately, educating adults and kids to eat right and stay active may wind up being just one of many tools that are used to help get the obesity epidemic within the U.S. (and around the globe) under control. It's possible that pharmaceutical options or even medical devices could also be called upon to help solve this problem.
Within the last three years a trio of oral weight control management medicines were approved by the Food and Drug Administration and have found their way to pharmacy shelves. To be clear, these aren't geared at people looking to shed a few pounds for the summer, but are typically intended for people with a BMI of 30+.
Source: VIVUS.
VIVUS' (VVUS +0.00%) Qsymia has been on the market the longest, and in clinical studies it demonstrated the greatest percentage of overall weight loss. Unfortunately for VIVUS, it's the only one of the three drug developers that hasn't chosen to license its product to a larger pharmaceutical company. A combination of its inexperienced marketing staff and its slightly less-favorable safety profile compared to its peers have caused Qsymia sales to limp out of the gate rather than gallop. In Q1 2015, Qsymia sales totaled just $12.6 million, for an annual run rate of approximately $50 million. After nearly three years on the market, it's safe to say this wasn't a very successful launch.
Source: Arena Pharmaceuticals.
Prospects have been a bit better for Arena Pharmaceuticals' (ARNA +0.00%) Belviq. Belviq has been on the market about a year less than Qsymia despite being approved just weeks apart. This lag is due to the time it took for the U.S. Drug Enforcement Agency to schedule the weight control drug. Despite not having as impressive a weight loss percentage as Qsymia in clinical studies, Belviq does have a favorable safety profile, which could give it a small edge. That, and Arena is working with licensing partner Eisai to help market the product. In Q1 2015 Belviq generated $12.8 million in sales within the U.S., or a $51 million full-year run rate. It's a bit better than Qsymia, particularly considering its shorter time on pharmacy shelves, but these sales totals are still disappointing.
Source: Orexigen Therapeutics.
The third obesity drug player is Orexigen Therapeutics (NASDAQ: OREX) with its drug Contrave, which was approved by the FDA in September 2014. Orexigen and its licensing partner Takeda Pharmaceuticals looked as if they could have the perfect combination of safety and efficacy considering that a multi-year cardiovascular outcomes study known as the Light Study was nearing completion. However, Orexigen's dissemination of interim data from the Light Study prior to its completion may have biased the study, resulting in the Light Study being scrapped. Orexigen announced that another cardiovascular outcomes study is expected to be undertaken later this year with a new completion date of 2022. This news is particularly saddening because Contrave sales had zoomed out of the gate, totaling $11.5 million in Q1 2015. It'll be interesting to see if Contrave's sales momentum slows in the coming quarters following its Light Study news.
Here's what I think you should really be watching
The aforementioned oral weight control management products designed to make you feel fuller were expected to revolutionize the obesity landscape, but thus far it looks like they've had only a marginal effect. My suggestion would be to keep your eyes peeled on two up-and-coming possible solutions.
Within the pharmaceutical arena I'd closely monitor what Zafgen (ZFGN +0.00%) is attempting to do to fight obesity. Instead of attacking obesity from the standpoint of making you feel full, the company's lead experimental drug, beloranib, is an inhibitor of MetAP2 which is designed to reduce the production of new fatty acid molecules by the liver, and to turn stored fats into energy. Thus far Zafgen has completed two phase 2a studies examining the safety of beloranib, and in three phase 1b studies it observed weight loss of approximately 2.2 pounds per week in patients, as well as improved cardiovascular risk factors.
Keep in mind that Zafgen's first target with beloranib will be subgroups of the population with rare conditions, but Zafgen does have every intention of expanding the use of beloranib following its first FDA approval. Realistically, a possible FDA approval is still a number of years out.
I'm also incredibly intrigued to see how EnteroMedics' newly-approved implantable device will fare.
Source: EnteroMedics.
Earlier this year, the FDA announced the approval of the vBloc Neurometabolic Therapy, an implantable device that works by intermittently blocking the vagus nerve, which is the primary regulator of the digestive system. The study that led to vBloc's approval showed that patients treated with the device achieved a 24.4% excess weight loss after one year.
Personally, I believe this data suggests vBloc can be a success, but that doesn't mean there aren't challenges ahead for the device or EnteroMedics. At an estimated cost of $15,000, EnteroMedics may have to hope it lands a lot of private payers, otherwise insurers may shy away from authorizing the procedure or picking up the tab.
Additionally, EnteroMedics is a micro-cap company, and it's burning through its remaining cash on hand while it trains surgical centers and surgeons how to implant the vBloc Neurometabolic Therapy. Despite these concerns, the technology is certainly worth watching, and it could make a big difference those patients with BMIs of at least 40 to 45, or between 35 and 39 with at least one serious health-related condition.
How will the obesity epidemic eventually be stopped? That's a question that no one can answer with any certainty, but let's just say I wouldn't be surprised if Zafgen or EnteroMedics didn't become contributors to the eventual solution.
