Xenical, New Weight Loss Drug...Online!
The process of testing and then approving a new drug can be quite
different from the marketing of that drug after it has been released.
The new fat-blocking drug orlistat (Xenical) provides a case in point.
On April 26, 1999, the U.S. Food and Drug Administration (FDA)
announced that it had approved orlistat (Xenical), "a new drug to
treat obesity," noting that "orlistat is the first drug in a new
class of non-systemically acting anti-obesity drugs known as lipase
inhibitors." The FDA statement read, in part, as follows:
- "Unlike other obesity drugs, orlistat prevents enzymes in the
gastrointestinal tract from breaking down dietary fats into smaller
molecules that can be absorbed by the body. Absorption of fat is
decreased by about 30 percent. Since undigested triglycerides are not
absorbed, the reduced caloric intake may have a positive effect on
weight control."
- "The recommended dose of orlistat is one capsule with each main
meal that includes fat. During treatment, the patient should be on a
nutritionally balanced, reduced-calorie diet that contains no more
than 30 percent of calories from fat. Orlistat is indicated for obese
patients with a body mass index (BMI, a measure of weight in relation
to height), of 30 or more, or for patients with a BMI of 27 or more
who also have high blood pressure, high cholesterol, or diabetes. A
person who is 5´5" in height and weighs 180 pounds would have a BMI
of 30."
- "Because orlistat reduces the absorption of some fat-soluble
vitamins and beta carotene, patients should take a supplement that
contains fat soluble (A, D, E, and K) vitamins and beta carotene. The
most common side effects of orlistat are oily spotting, gas with
discharge, fecal urgency, fatty/oily stools and frequent bowel
movements."
Less than two months after the FDA approved orlistat (Xenical), an
online drugstore stated that, to order some Xenical, you simply had
to fill out and submit an online consultation form. The online
drugstore explained that:
- " Your online
consultation form will be sent to a qualified and licensed medical
doctor. The doctor will review your medical history/personal profile
and decide if Xenical is the appropriate treatment for your problem.
If appropriate the doctor will write a prescription which will be
sent to a qualified pharmacy. The pharmacy will then fill and ship
the medication to you....There is an on-line consultation fee of $75
for all approved prescriptions."
This online offer is far from unique. One search using the word
"Xenical" in the Excite! search engine yielded 2953 hits. The first
hit started something like an old-style street vendor with these
words:
- "XENICAL - Get Xenical, the new weight loss pill, Xenical
for sale."
Orlistat (Xenical) is by no means alone as a prescription drug now
being marketed online without a real visit with a physician. There
are many other prescription drugs already being hawked online. They
include "lifestyle" drugs such as Viagra (sildenafil citrate) for
erectile dysfunction, Propecia (finasteride) for hair loss, and
Preven (Emergency Contraceptive/Birth Control Kit). The online drug
offerings also include relatively new and popular drugs such as the
antihistamine Claritin (loratadine) for allergy and the Cox-2
inhibitor Celebrex (celecoxib) for arthritis.
The basic issue is not whether prescription drugs will be sold
online. That is already well underway. But is filling out and
submitting an online consultation form an adequate medical
consultation? Is it as good as seeing a doctor in person? Whether
prescription drugs will be prescribed responsibly and sold
responsibly online is what is at stake.
Last Editorial Review: 7/7/2004