Ernest Nagel
is old
Oh, goody! Now if they'd just lower the size requirements for those penis enlargement pumps (and make them BIGGER) my life could be perfect. 
http://www.nytimes.com/2011/02/17/health/17obese.html?_r=1
F.D.A. Approves Band Device for Less Obese
By ANDREW POLLACK
Published: February 16, 2011
People no longer need to be quite as obese as before to qualify for weight loss surgery.
The Food and Drug Administration on Wednesday approved the wider use of Allergans Lap-Band stomach-restricting device to some people who are just barely obese.
Allergan estimated that more than 26 million Americans would be newly eligible for the surgery, more than doubling the 15 million to 18 million eligible under the old standard.
Still, Allergan did not get all it asked for. The F.D.A. lowered the weight requirement only for people who have a health problem related to obesity, like hypertension or diabetes, not for people who are heavy but otherwise healthy.
In order to target this therapy to patients who will benefit the most, the approved indication is limited to patients at the highest risk of obesity-related complications, said Karen Riley, a spokeswoman for the agency.
Allergan said it was pleased nonetheless.
Until now the Lap-Band has been approved for people with a body mass index, or B.M.I., of at least 40 if they have no obesity-related health problems and at least 35 if they have such a problem.
Allergan applied to lower the threshold to 35 for people without complications and to 30 for those with a related health condition.
The F.D.A. agreed to lower the requirement for those with an associated health condition to 30. But it left the requirement for otherwise healthy people at 40. An index of 30 is considered the lower boundary of obesity.
Under the previous rules, a person who is five-foot-six and has diabetes would have had to weigh 216 pounds to qualify. Now that person would have to weigh only 186 pounds.
An advisory committee to the F.D.A. voted 8 to 2 in December to endorse the wider use of the Lap-Band, concluding that the benefits of the device exceed the risks for the patients in the lower range of obesity.
Some experts say the expanded approval for the Lap-Band, combined with a dearth of weight-loss drugs, will drive more moderately obese people to consider surgery. In recent months the F.D.A. declined to approve three new diet pills and forced the withdrawal from the market of an older drug, Meridia.
The Lap-Band is approved for use only in people who have failed to lose weight by diet, exercise or drugs.
The Lap-Band is an inflatable silicone ring that is placed around the upper part of the stomach. It restricts how much a person can eat and makes one feel full more quickly.
In the study Allergan submitted to win the expanded approval, patients lost an average of 18 percent of their weight after a year. Allergan has agreed to follow patients in that study for another five years.
The company, based in Irvine, Calif., is hoping to increase sales of the Lap-Band, which it says have been soft because of the poor economy. Still, it expects obesity product sales of $220 million to $240 million this year. That is a small part of its business; Allergan is best known for the Botox wrinkle treatment.
A version of this article appeared in print on February 17, 2011, on page B4 of the New York edition.
http://www.nytimes.com/2011/02/17/health/17obese.html?_r=1
F.D.A. Approves Band Device for Less Obese
By ANDREW POLLACK
Published: February 16, 2011
People no longer need to be quite as obese as before to qualify for weight loss surgery.
The Food and Drug Administration on Wednesday approved the wider use of Allergans Lap-Band stomach-restricting device to some people who are just barely obese.
Allergan estimated that more than 26 million Americans would be newly eligible for the surgery, more than doubling the 15 million to 18 million eligible under the old standard.
Still, Allergan did not get all it asked for. The F.D.A. lowered the weight requirement only for people who have a health problem related to obesity, like hypertension or diabetes, not for people who are heavy but otherwise healthy.
In order to target this therapy to patients who will benefit the most, the approved indication is limited to patients at the highest risk of obesity-related complications, said Karen Riley, a spokeswoman for the agency.
Allergan said it was pleased nonetheless.
Until now the Lap-Band has been approved for people with a body mass index, or B.M.I., of at least 40 if they have no obesity-related health problems and at least 35 if they have such a problem.
Allergan applied to lower the threshold to 35 for people without complications and to 30 for those with a related health condition.
The F.D.A. agreed to lower the requirement for those with an associated health condition to 30. But it left the requirement for otherwise healthy people at 40. An index of 30 is considered the lower boundary of obesity.
Under the previous rules, a person who is five-foot-six and has diabetes would have had to weigh 216 pounds to qualify. Now that person would have to weigh only 186 pounds.
An advisory committee to the F.D.A. voted 8 to 2 in December to endorse the wider use of the Lap-Band, concluding that the benefits of the device exceed the risks for the patients in the lower range of obesity.
Some experts say the expanded approval for the Lap-Band, combined with a dearth of weight-loss drugs, will drive more moderately obese people to consider surgery. In recent months the F.D.A. declined to approve three new diet pills and forced the withdrawal from the market of an older drug, Meridia.
The Lap-Band is approved for use only in people who have failed to lose weight by diet, exercise or drugs.
The Lap-Band is an inflatable silicone ring that is placed around the upper part of the stomach. It restricts how much a person can eat and makes one feel full more quickly.
In the study Allergan submitted to win the expanded approval, patients lost an average of 18 percent of their weight after a year. Allergan has agreed to follow patients in that study for another five years.
The company, based in Irvine, Calif., is hoping to increase sales of the Lap-Band, which it says have been soft because of the poor economy. Still, it expects obesity product sales of $220 million to $240 million this year. That is a small part of its business; Allergan is best known for the Botox wrinkle treatment.
A version of this article appeared in print on February 17, 2011, on page B4 of the New York edition.
