May 17, 2011

Several non-surgical attempts to address obesity epidemic fail

Bariatric surgery and novel, non-surgical devices for weight loss were among the most popular topics at the 2011 Digestive Disease Week (DDW, Bethesda, Maryland) annual meeting. The DDW annual meeting is jointly sponsored by the American Association for the Study of Liver Diseases (Alexandria, Virgina), The American Gastroenterological Association (Bethesda, Maryland), the American Society for Gastrointestinal Endoscopy  Oak Brook, Illinois), and the Society for Surgery of the Alimentary Tract (Beverly, Massachusetts). The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. 

The search for technologies that can address the complex multi-factorial, and now deemed lethal, disease called obesity has been disappointing for both drug and device companies.

In a joint symposium “The Epidemic of Obesity: Surgical Implications,” Raul Rosenthal, MD, Bariatric Surgeon, Cleveland Clinic (Weston, Florida) said, “Obesity is a disease that is now the number two cause of premature death in America, over smoking.” The WHO has listed obesity among the top 5 conditions that need to be addressed worldwide; and for the fi rst time in global history, there are more overweight people than starving people in the world. “With over $100 billion spent in the U.S. annually to treat obesity, and 61% of all Americans being obese, we
are going to run out of money to treat this disease,” said Rosenthal, “We need early interventions and preventative treatments,” he concluded.

Obesity not only drives the incidence of diabetes and cardiovascular disease up, but recent findings show that it also increases the incidence of cancer. Jeffrey Peters, MD, chair of the department of surgery, University of Rochester Medical Center (Rochester, New York) said “The link  between obesity and cancer emerged in 2003 and since then we have discovered that the cancers most sensitive to obesity are those of the GI tract: liver, esophageal, colorectal, etc. Of those cancers, up to 20% are attributable to obesity, and colon cancer can rise by 50%.”
He cited a Swedish study that found the cancer risk declined after bariatric surgery, and following gastric bypass surgery, there was a 300% lower risk of death in that study. Overall, there were 68% fewer deaths due to any cancer in patients who had gastric bypass surgery. “This was an unexpected profound observation,” claimed Peters, who concluded with “Like tobacco and alcohol, is sugar another killer?” To which the moderator asked, “Should there be a twinkie tax?”

Surgeries for obesity have been around since the 1980s, and although an immediate weight loss and sometimes remission of diabetes is seen early; after time, weight regain occurs in up to 50% of the patients. Marina Kurian, MD, medical director of the department of surgery, bariatric
division at the New York University (NYU) Langone Medical Center (New York) discussed the pros and cons of the two current lap bands being manufactured and marketed in the U.S. by Allergan (Irvine, California) and Ethicon Endo-Surgery (Cincinnati). Outside of the U.S. there are other bands being used such as Helioscopie (France), Midband (Dardilly, France), and others; but her talk was based only on the U.S. bands. She said that “Restriction is critical to long term weight loss,” which is why bypass patients often have weight regain because their stomach pouches have stretched out. With bands, continual monitoring and adjustment of the band helps patients maintain weight loss. 

More than 300,000 bands have been placed in the U.S. with 42%-68% reported excess weight loss (EWL) at 2 years. In January, the FDA changed the current requirements for eligibility to get lap band surgery; lowering the body mass index (BMI) from 35 to 30 with co-morbidities and 35 without co-morbidities. “The safety profi le of bands is better than with other surgeries,” she claimed “but sometimes gastric bypass or sleeve gastrectomy result in greater weight loss. The bands are safer but may have less weight loss unless the patient is dedicated to continual follow-up.”

Ninh Nguyen, MD, chief of the division of gastrointestinal surgery at the UC Irvine Medical Center (Irvine, California) compared lap bands with gastric bypass procedures (See Table 1) and found, “Bypass procedures had better outcomes but at what cost?” The doctor and the
patient make risk-reward decisions concerning which type of procedure is best for a specifi c patient. Currently, about 46% of the patients have adopted the band while about 44% selected to undergo gastric bypass surgery.

“Right now the band is the second most common form of bariatric surgery with lower morbidities and 1/3 lower mortality,” Nguyen concluded.

There are 22 million Americans who qualify for bariatric surgery and 300,000 deaths annually attributable to obesity but less than one percent of those people have the surgery. If every bariatric surgeon did 5 cases a day for 20 years, they would not put a dent in the number of untreated patients. The quest for a non-surgical solution to the problem has been prominent among start-up medical device companies. Sreeni Jonnalagadda, MD, professor of medicine, Washington University (St. Louis), presented the various ways manufacturers have been trying to come up with a non-surgical solution using a medical device placed endoscopically. He discussed intragastric balloons by Bioenterics (Carpinteria, California), Spatz (Jericho, New York) and ReShape (San Clemente, California); none of which are FDA cleared yet. He then described the two duodeno-jejunal bypass liner devices by GI Dynamics (Lexington, Massachusetts) and ValenTx (Carpinteria, California) where early trials show both weight loss and diabetes remission. Then there were those devices that are not continuing in development. Satiety’s (Palo Alto, Califonia) TransOral Gastroplasty, or TOGA, system that showed a 52% EWL at 12 months in one study, “For reasons not made public, investors decided not to pursue further device development,” Jonnalagadda said. “There is no known ongoing device developments in endoluminal vertical gastroplasty devices at this time,” he also told the audience. Power Medical (now Covidien (Mansfield, Massachusetts), C.R. Bard (Murray Hill, New Jersey), Cook Medical (Bloomington, Indiana) and Olympus Medical (Center Valley, Pennsylvania) had all been looking into this space. The transoral endoscopic restrictive implant (TERIS) system by BaroSense (Redwood City, California) is not being developed further due to unacceptable durability of anchor points. In conclusion, Jonnalagadda said, “The FDA, industry and investigators need to formulate guidelines regarding optimal study design and expectations for endoscopic devices in this arena.”