Lap Band Debate

Today, at Obesity 2011, a debate was held on the decision of the FDA to approve the Lap-Band® for individuals with a BMI as low as 30 with a co-morbidity. Dr. John Dixon and Dr. Edward Livingston took the two sides in this debate.

The first speaker was Dr. John Dixon, who argued that the FDA made a good decision. He opened by saying that the determinants of obesity are complex; obesity is a chronic, serious relapsing disease. Dr. Dixon went on to say “prevention and treatment of a disease are different. We don’t put sunscreen on melanoma to cure it.” The Lap-Band® was a treatment option that was seen as effective, and the choice was made to expand its range of use, which is what happens with many types of treatments. Those with lower BMI need effective treatment, Dixon added, and there is a serious lack of drug options.

Dr. Dixon highlighted that the Lap-Band® this is not an easy way out, that the band must be actively managed, and many band patients feel like for the first time they have something helping them as they make changes in their eating behaviors and lifestyle. Non-surgical weight loss leads to increased hunger and reduced cognitive restraint. On the other hand, surgical weight loss reduces hunger and increases cognitive restraint.

For this approval, the FDA required a trial that resulted in 40% of the patients showing 30% EWL (excess weight loss). A much higher rate ultimately achieved the threshold of 40% EWL by the end of the trial: 83.9% actually achieved it. Dr. Dixon then showed some results of a clinical trial that he conducted that showed surgical vs. non-surgical weight loss trajectories were similar for 6 months, but after the 6 month point, the paths diverged quite noticeably; the surgical patients continued to lose weight, where the non-surgical group gained the weight back. He argued that the band surgery is safer and simpler than other procedures.

Dr. Dixon went on to address earlier safety concerns with the Lap-Band®, and said that newer techniques in placing and filling the band has made the band easier and safer than it was when it was first approved. Dr. Dixon ended by saying “if there’s a good drug – a wonder drug – in 2 years, 5 years, or 10 years then we could remove this device as an option. But we don’t have that now.” All chronic disease needs a range of choices, he concluded, and the Lap-Band® is an effective choice.

Dr. Jaime Ponce of Gastric Band Institute spoke to us about the debate, and agreed with both speakers who said that BMI is not a good indicator of whether surgery is indicated: “The BMI is an arbitrary number that has been suggested in the past as an indicator for bariatric surgery. The reality is that patients with obesity class I (BMI 30-35) have already 30% greater mortality than normal BMI population, have a 3 yrs average decrease in lifespan, increase in Type 2 Diabetes by 3 fold, and double the incidence of hypertension and dyslipidemia (high cholesterol). So, when these patients can’t get good results with medical therapy, then surgery is the best treatment option as the effectiveness of surgery in this BMI range has been documented to be very good.”

On the other side of the debate, Dr. Edward Livingston argued that the FDA’s decision was inappropriate. Dr. Livingston agreed that BMI is not a good indication of the need for obesity surgery, but that co-morbidities are. He opened by talking about the specifics of the FDA’s decision. The FDA is responsible for deciding that devices are safe and effective, he said, and that they did not address the appropriateness of using the Lap-Band on patients with a BMI as low as 30. He highlighted that the study only looked at weight loss, and not at co-morbidities, and that only 64 of the patients in the study had a BMI of between 30 and 35. He agreed that the weight loss seen in this study was very good. Although it was a small sample size, and the study was not geared to look at co-morbidities, Dr. Livingston said the results showed that two thirds of patients in the study did not improve their co-morbid conditions.

“Although we agree that the surgical technique used early in the Lap-Band’s history led to the complications seen in earlier studies, there is not enough positive follow-up data yet,” said Dr. Livingston. The FDA has required that follow up data be provided from 75% of the FDA study participants, and he says this level of follow up is very hard to achieve. He also expressed concern that his practice does not show the same results as the FDA trial, especially in the long term. He attributes some of the difference in success to the fact that the study participants received all their care for free, and were actively involved in follow up. Dr. Livingston says yes, surgical treatments can work, but non-surgical options can also achieve very successful results in obese patients when the care is given for free and with active follow up like was seen the Lap-Band® trial.

He concluded, “Much more data needs to be accumulated before we say it’s appropriate, especially with the effects on co-morbidities. Lower BMI patients can lose weight without surgery if the treatments are paid for.”

Dr. George Fielding also spoke with us about the issue of the Lap-Band for lower BMI patients: “Finally, reality has set in. Given the tsunami-like surge in obesity and its associated disease, and the mounting evidence that these diseases come with a lower BMI than once thought, it’s time for everyone to get on board with offering surgical help for our patients with a lower BMI. This is a huge step forward for the millions of people who need our help with surgical treatment of their disease. The safety of the band, its efficacy in controlling co-morbidities, and the data on its effectiveness in these lower BMI patients, strongly supports use of the band in this group of patients.”

Dr. Ponce concluded: “We have gastric band studies with high level of evidence, including two prospective randomized clinical trials showing extremely good weight loss and improvement in diabetes in these patients. Other studies have documented weight loss with the gastric band in the range of 42-87% EWL at 1-5 years follow-up. The FDA looked at a study with the Lap-Band® showing 64% EWL at 1 year in 143 patients in a multi-center trail with minimal complications. Obesity is a disease, with chronic medical consequences, the tipping point is a BMI of 30, and should be treated. Bariatric surgery should be one of the options.”