In the June 15, 2005 edition of JAMA (as reported by the Sacramento Bee) a new study was published reporting the data from a study in which 539 obese adolescents ages 12 to 16 were randomized into a double-blind, controlled study for 54-weeks to see the weight-loss with and without the weight-loss drug Orlistat, sold under the brand name Xenical.
The study found that more than one-quarter (25%) of the Xenical patients, compared with 15% of the group getting a placebo, had a 5% or higher decrease in their body mass index (BMI). Similarly, while both groups regained weight lost during the first four weeks of the study, the Xenical group had gained less weight than the control group by the end of the trial. The Xenical patients also experienced a reduction in their hip and waist circumference, while those on a placebo saw an increase.
Xenical, first approved for adults in 1999, works by decreasing the intestines' ability to absorb fat. It does that by inhibiting an enzyme called lipase, which normally cuts the fat into small pieces so it can be absorbed. The study, completed in 2002, was key in the Food and Drug Administration's approval in 2003 of Xenical for use in children 12 and older.
Because Xenical's action is in the gut, the drug is considered safer than others designed to aid weight loss. But it is not without side effects. As with adults, the drug triggered gastrointestinal problems in many study participants. Half of them (50%) complained of having fatty or oily stools and nearly 30% reported oily spotting.
The research also raises concerns that doctors may be tempted to prescribe the drug without a program to teach and monitor behavior changes. Because the drug is often used indefinitely in adults, childhood obesity experts wonder whether Xenical would prove safe and effective if used for a long time.
In my opinion, this is another example of the disturbing trend today to seek a "magic bullet" for the obesity epidemic. No one wants to be told they have to work hard to lose weight, make permanent changes in their eating habits - that there is no "magic bullet" out there that will make it go away. But that is the brutal truth - you simply cannot lose weight and keep it off unless you modify your eating habits and lifestyle permanently!
The differences in weight reduction between the two groups (15% versus 25% losing 5% of their BMI) is not, in my opinon, impressive. Especially when you take into consideration the high incidence of side-effects in the trial group. Add to that the need to remain on the drug over the long-term and it is simply a problem, not a solution. We need solutions!
As a society, do we really want to be teaching our youth that popping a pill for the rest of their life is the answer to their weight problem?
Or do we want to instill in them a sense of confidence in their own ability to make the commitment to themselves that they can take control of their eating habits and lifestyle and enable them with accurate information and knowledge about nutrition and health to eat right and be active?