Marie Gahler, Sr. Manager, Weight Programs and Education:

2011 brings more choices to fight obesity! The FDA advisory committee has voted to approve both a new weight loss medication Contrave, as well as voted to lower the minimum BMI requirement for the Lap-band, an Allergan product. This is welcome news to those of us working in obesity treatment, especially after a frustrating year of disappointments. In October the FDA rejected two other possible weight loss medications and asked that another be taken off the market. Those actions left us with only one prescription weight loss drug for patients.

The new drug called Contrave is a combination of two drugs that have been on the market for some time now and have good safety records. The drugs are naltrexone, used to treat alcohol and drug addiction, and bupropion (known as Wellbutrin), an antidepressant, which is also used to help people quit smoking. The Obesity Society is in favor of approval of Contrave and its president, Free & Clear’s own Jennifer Lovejoy, has spoken on the necessity of this new option. Weight loss medications are an essential tool for those who are unable to lose weight with diet alone. Those approved have been shown in clinical trials to be effective and helping people lose weight. Studies have also shown their use can improve cardiovascular risk including reducing blood pressure and lower the risk of metabolic disease and diabetes.

Weight loss surgery is considered the only permanent, long-term treatment for weight loss by obesity experts. The Lap-band previously has been approved for individuals with a BMI of 40≤ with no related disease states and 35≤ with one or more. If the FDA’s vote is approved, the numbers of individuals eligible for the band will more than double in the US.

One of the FDA’s questions in regards to the studies done on lower BMI patients with the band is whether the weight loss has been significant. The study done by Allergan showed 80% of those receiving the band lost at least 30% of their excess weight and some lost significantly more. Even a 5-10% lose of weight has been shown to significantly improve health. Use of the band has been proven to reduce blood pressure, resolve diabetes, and reduce cardio vascular risk. Another argument for the reduction in BMI is that the learning curve for surgeons and the safety of these procedures have improved greatly since the original limits on BMI were set back in 1991. Many Lap-band surgeons operate at a facility that has earned the Center of Excellence distinction. This ensures the surgeon has completed at least 100 surgeries, does the procedure regularly, and the facility is prepared to supports obese patients.

Safety is of course an important issue with weight loss surgery; the 30-day mortality rate is for Lap-band is .01%. That rate is similar to bariatric surgery but the band does not surgically change one’s anatomy. Bariatric surgery surgically removes parts of the stomach and small intestine. It does, however, produce better weight loss, a higher resolution of diabetes and generally produces a significant decrease in appetite compared with the band. I would suggest that anyone with a BMI of 40 or over consider bariatric surgery over Lap-band.

The fact that these two FDA decisions were made so close together really support each other. No one option is right for all individuals and having more prescription medication options provides steps for people to try in their efforts to lose weight. There are excellent self help and counseling programs available like Mind & Body, and we now again have two medications to try as well. Surgery is a last resort and I encourage people to try all other options available before considering that more invasive and riskier choice.

So, while helping individuals reduce their size and return to a healthier weight is difficult, it looks like the FDA has voted to improve the options available to those who are trying. I am confident that the FDA will follow the voting and give final approval of both Contrave and the lower BMI levels for Lap-band in the months to come.