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Wed, May-03-06, 04:30
Allergan's Weight-Loss Bands Beat Diet, Exercise, Study Says
May 1 (Bloomberg) -- Allergan Inc.'s adjustable weight-loss bands, implanted around the stomach to make patients feel ``full'' sooner, are superior to behavioral weight-loss treatments for the mildly obese, a study said.
U.S. regulators and insurers now approve the bands only for severely obese people, a group that includes, for instance, a 5- foot, 10-inch person who is 100 pounds or more overweight. The study focused on a group that includes people the same height who are as few as 35 pounds overweight.
Patients who received Allergan's LAP-BAND System in a minimally invasive surgical procedure weighed an average of 45 pounds less after two years, compared with 11.6 pounds less for those with non-surgical treatment, said an article in the Annals of Internal Medicine. The weight loss also triggered biochemical shifts that made patients healthier, researchers said.
``The idea of relying on behavioral programs, which have failed for years, is just ludicrous,'' said Mitchell Roslin, an obesity surgeon at Lenox Hill Hospital in New York, in a telephone interview today. ``Clearly an effective treatment of obesity will require medical devices, or else better medications that aren't yet available.''
This is the first randomized, controlled study on the effectiveness of gastric bands on moderate obesity, the researchers said. The U.S. Food and Drug Administration and public and private health insurers have been reluctant to extend approval of the $3,000 device to the moderately obese, Roslin said.
Demand Increase
The findings, reported by researchers at Monash University in Melbourne, Australia, may increase demand for the device, Roslin said. The bands were implanted in 20,000 to 30,000 patients in the U.S. last year and the market may grow to 300,000 in 2010, he said. Johnson & Johnson is expected to win approval next year for a competing band product.
Patients in the study who received the gastric bands were less likely to have metabolic syndrome, a cluster of conditions that increase risks of type 2 diabetes and cardiovascular disease, said lead author Paul O'Brien, director of Monash's Centre for Obesity Research and Education. More than 50 million people in the U.S. have metabolic syndrome, according to the American Heart Association.
At the start of the study, 15 patients in each group had metabolic syndrome. After two years, one patient in the banding group and eight in the non-surgical group had it.
``These positive results suggest that physicians should re- examine the guidelines for weight-loss surgery to determine if they should be expanded to include mild to moderately obese patients,'' O'Brien said in a statement.
Study Focus
The study focused on 80 patients with a body mass index of 30 to 35, a measure of weight that takes height into account. As examples, a 5-foot 3-inch patient weighing 170 to 200 pounds and a 5-foot 10-inch patient weighing 210 to 245 pounds would be eligible.
Each patient was randomly assigned to receive the gastric bands, made by Irvine, California-based Allergan, or undertake a traditional non-surgical weight loss program. The non-surgical program was run by a physician and included behavioral modifications, a low-calorie diet and drug therapy with orlistat, sold as Xenical by Basel, Switzerland-based Roche Holding AG, plus diet and exercise education and professional support.
After 24 months, patients who received surgery lost an average of 21.6 percent of their body weight while the control group lost 5.5 percent.
Implanting the Bands
To implant the bands, surgeons make several incisions in the abdomen and insert a belt with an inflatable collar that encircles the upper part of the stomach. The doctor injects saline solution into the bands to tighten the fit and reduce stomach capacity as needed.
Outpatient adjustments in the fit can be made through an abdominal port that leads to an inflation-deflation tube. The entire device can be removed using the same minimally invasive procedures.
O'Brien's research was partly sponsored by Allergan. An editorial in the Annals of Internal Medicine faulted O'Brien for providing too little detail about the treatment given to non- surgical patients. It called for more studies.
Roslin said the banding procedure has fewer complications than more complex and expensive bariatric operations, such as gastric bypass, which permanently makes the stomach smaller. A gastric bypass is considered by researchers to be both more effective and riskier. It costs $10,000 and requires hospitalization.
Sales
Allergan's LAP-BAND System generated sales of $131 million in 2005, said Ronny Gal, an analyst with Sanford C. Bernstein & Co. in New York, in a telephone interview today. He projects sales of $173 million this year.
``Most docs I spoke with have been a bit cautious about this,'' Gal said. ``They worked very hard to convince the managed care community that obesity treatment is a health care issue, and not a vanity issue. Payers are somewhat afraid about people saying, `You're somewhat overweight, let me do lap-band surgery on you. You might not have a medical problem, but you'll look better and feel better.'''
Roslin did not dismiss behavioral approaches completely. Educational efforts can succeed if they begin in the schools, he said. ``We should have behavioral programs for young children to halt the epidemic, but its going to take generations, just like smoking,'' Roslin said.
To contact the reporter on this story:
Avram Goldstein in Washington at agoldstein1~bloomberg.net.
Last Updated: May 1, 2006 17:00 EDT
http://www.bloomberg.com/apps/news?pid=10000082&sid=aKU8LF.bc0qk&refer=canada#
May 1 (Bloomberg) -- Allergan Inc.'s adjustable weight-loss bands, implanted around the stomach to make patients feel ``full'' sooner, are superior to behavioral weight-loss treatments for the mildly obese, a study said.
U.S. regulators and insurers now approve the bands only for severely obese people, a group that includes, for instance, a 5- foot, 10-inch person who is 100 pounds or more overweight. The study focused on a group that includes people the same height who are as few as 35 pounds overweight.
Patients who received Allergan's LAP-BAND System in a minimally invasive surgical procedure weighed an average of 45 pounds less after two years, compared with 11.6 pounds less for those with non-surgical treatment, said an article in the Annals of Internal Medicine. The weight loss also triggered biochemical shifts that made patients healthier, researchers said.
``The idea of relying on behavioral programs, which have failed for years, is just ludicrous,'' said Mitchell Roslin, an obesity surgeon at Lenox Hill Hospital in New York, in a telephone interview today. ``Clearly an effective treatment of obesity will require medical devices, or else better medications that aren't yet available.''
This is the first randomized, controlled study on the effectiveness of gastric bands on moderate obesity, the researchers said. The U.S. Food and Drug Administration and public and private health insurers have been reluctant to extend approval of the $3,000 device to the moderately obese, Roslin said.
Demand Increase
The findings, reported by researchers at Monash University in Melbourne, Australia, may increase demand for the device, Roslin said. The bands were implanted in 20,000 to 30,000 patients in the U.S. last year and the market may grow to 300,000 in 2010, he said. Johnson & Johnson is expected to win approval next year for a competing band product.
Patients in the study who received the gastric bands were less likely to have metabolic syndrome, a cluster of conditions that increase risks of type 2 diabetes and cardiovascular disease, said lead author Paul O'Brien, director of Monash's Centre for Obesity Research and Education. More than 50 million people in the U.S. have metabolic syndrome, according to the American Heart Association.
At the start of the study, 15 patients in each group had metabolic syndrome. After two years, one patient in the banding group and eight in the non-surgical group had it.
``These positive results suggest that physicians should re- examine the guidelines for weight-loss surgery to determine if they should be expanded to include mild to moderately obese patients,'' O'Brien said in a statement.
Study Focus
The study focused on 80 patients with a body mass index of 30 to 35, a measure of weight that takes height into account. As examples, a 5-foot 3-inch patient weighing 170 to 200 pounds and a 5-foot 10-inch patient weighing 210 to 245 pounds would be eligible.
Each patient was randomly assigned to receive the gastric bands, made by Irvine, California-based Allergan, or undertake a traditional non-surgical weight loss program. The non-surgical program was run by a physician and included behavioral modifications, a low-calorie diet and drug therapy with orlistat, sold as Xenical by Basel, Switzerland-based Roche Holding AG, plus diet and exercise education and professional support.
After 24 months, patients who received surgery lost an average of 21.6 percent of their body weight while the control group lost 5.5 percent.
Implanting the Bands
To implant the bands, surgeons make several incisions in the abdomen and insert a belt with an inflatable collar that encircles the upper part of the stomach. The doctor injects saline solution into the bands to tighten the fit and reduce stomach capacity as needed.
Outpatient adjustments in the fit can be made through an abdominal port that leads to an inflation-deflation tube. The entire device can be removed using the same minimally invasive procedures.
O'Brien's research was partly sponsored by Allergan. An editorial in the Annals of Internal Medicine faulted O'Brien for providing too little detail about the treatment given to non- surgical patients. It called for more studies.
Roslin said the banding procedure has fewer complications than more complex and expensive bariatric operations, such as gastric bypass, which permanently makes the stomach smaller. A gastric bypass is considered by researchers to be both more effective and riskier. It costs $10,000 and requires hospitalization.
Sales
Allergan's LAP-BAND System generated sales of $131 million in 2005, said Ronny Gal, an analyst with Sanford C. Bernstein & Co. in New York, in a telephone interview today. He projects sales of $173 million this year.
``Most docs I spoke with have been a bit cautious about this,'' Gal said. ``They worked very hard to convince the managed care community that obesity treatment is a health care issue, and not a vanity issue. Payers are somewhat afraid about people saying, `You're somewhat overweight, let me do lap-band surgery on you. You might not have a medical problem, but you'll look better and feel better.'''
Roslin did not dismiss behavioral approaches completely. Educational efforts can succeed if they begin in the schools, he said. ``We should have behavioral programs for young children to halt the epidemic, but its going to take generations, just like smoking,'' Roslin said.
To contact the reporter on this story:
Avram Goldstein in Washington at agoldstein1~bloomberg.net.
Last Updated: May 1, 2006 17:00 EDT
http://www.bloomberg.com/apps/news?pid=10000082&sid=aKU8LF.bc0qk&refer=canada#