By
Dan Vergano, Medical Tribune News Service
WASHINGTON,
D.C. -- Government approval this week of a new obesity drug should
change treatment standards for the severely overweight, according
to medical experts. But they caution that the new drug, Xenical,
falls short of being a perfect solution for obesity.
As
many as 38 million Americans could be considered obese, according
to the National Heart, Lung, and Blood Institute (NHLBI) in Bethesda,
Md. Obesity is defined as being more than 20 percent overweight
for one's age, sex and height.
Simply
being overweight, a description that fits about 55 percent of
Americans, substantially increases an individual's risk of dying
from diabetes, heart disease, stroke and a host of other ailments,
according to the NHLBI.
Citing
obesity's health risks, the Food and Drug Administration (FDA)
approved Xenical, the first of a new type of weight-loss drug,
on Monday.
Unlike older drugs, which decrease appetite by altering brain
chemistry, the new drug works directly on the gastrointestinal
tract. By design, Xenical blocks up to one-third of fat molecules
consumed in a meal from absorption by the intestines, preventing
the calorie-rich compounds from reaching the bloodstream and subsequently
adding more weight to an individual, according to drug maker Hoffmann-La
Roche of Nutley, N.J. The drug's generic name is orlistat.
``It's
not a miracle cure,'' said drug developer Dr. Jonathan Hauptman
of Hoffmann-LaRoche, who added that patients must be motivated
and dieting in order to lose weight while taking the drug.
Xenical
underwent much scrutiny before garnering FDA approval. After some
participants in one trial of the drug developed breast cancer,
the federal agency asked for more safety information. The latest
studies, conducted in Europe and presented to a government advisory
committee in January, showed more cases of breast cancer among
people taking a dummy version of the drug, rather than the actual
medication.
Nevertheless,
the committee members, whose recommendations generally carry great
weight in the approval process, split their votes five-to-five
for and against releasing the drug.
``I've
personally concluded the breast cancer was a chance finding, a
statistical fluke,'' said Dr. Eric Coleman, an FDA medical officer
involved in the approval process.
With obesity increasing nationwide, he said the agency felt assured
of a need for this ``modestly effective'' drug. A host of drugs
approved more than 20 years ago to treat obesity are only available
for short-term use, he noted.
And
after the makers of fenfluramine (the ``fen'' in ``fen-phen'')
and dexfenfluramine (sold as Redux) pulled the obesity drugs off
the market in 1997 after studies linked them to heart-valve defects,
concerns remain about the possible side effects of drugs that
are still available, such as subutramine (sold as Meridia).
``Patients
have to understand it's not going to work alone,'' to reduce their
weight, said obesity expert Dr. Arthur Frank of George Washington
University in Washington, D.C. He suggests the fat molecules blocked
by Xenical, which can produce the awkward side effects of flatulence,
indigestion and oily stools, serve as a behavior modifier to get
people on a healthier diet. The richer the food, the worse the
side effects, agreed Hauptman.
Because
the drug also blocks the absorption of some nutrients in dietary
fats, the FDA recommends Xenical users take a daily multivitamin
containing vitamins A, D, E, K and beta carotene.
One advisory panel member who voted against the drug, Dr. Jules
Hirsch, physician-in-chief-emeritus of Rockefeller University
in New York, suggested that approval was a mistake, citing side
effects and the drug's limited effects.
``Everyone
agrees the weight loss is not too great,'' he said, noting that
a typical 200-pound man on the drug might lose just eight pounds
when taking the drug and following a well-balanced diet. Some
evidence shows the weight loss only lasts for a few years, he
added.
``Some
people will find it useful in seeing a small weight loss, but
in the aggregate, it's not very helpful.''
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