Diet Drug May Not Be Miracle Pill
Some Thought
December 6, 2004
AKRON, Ohio - It's a miracle diet pill that melts away
the pounds and suppresses those nasty hunger urges that
can doom any diet.
Even better, it keeps the weight off for years.
It's called Acomplia, and the initial buzz has been
nothing short of breathless, since results were released
at the American Heart Association's annual meeting last
week.
Patients lost 19 pounds, on average, over two years.
Their HDL (good) cholesterol went up. Their triglycerides
(a bad cholesterol) went down. And their waistlines
shrank - an especially significant result, considering
that abdominal fat is a key predictor of heart disease
and diabetes.
It all sounds wonderful. And, ultimately, it may be.
But Larry Frazee, a pharmacotherapy specialist at Akron
General Medical Center, suggests that people temper
their enthusiasm for now.
"My first impression is, it seems like the old
panacea," said Frazee, who studies data regarding
the clinical and biomedical effects of medications.
"I don't know how many times we've been told about
drugs that can do everything for you. There's always
a downside. I think we've been burned by so many drugs
that came out on the market. Vioxx is the most recent
example."
Merck & Co. pulled its arthritis drug Vioxx off
the market in September, after a study showed that the
drug doubled the risk of heart attack and stroke. And
before Vioxx, there was fen-phen, another miracle diet
drug.
Like Acomplia, fen-phen - and off-label combinations
of fenfluramine and phentermine - showed astounding
results. In a National Institutes of Health study in
the late 1980s, patients lost an average of 32 pounds.
The drug also suppressed appetite and improved insulin
function.
Doctors began peeling off prescriptions at a furious
rate.
But as the drug reached the masses, serious side effects
revealed themselves. By 1997, the drug was pulled from
the market, linked with dozens of deaths and heart valve
damage.
No one is suggesting that Acomplia will lead to Vioxx-
or fen- phen-like heart problems. But both drugs serve
as cautionary tales of what can happen when drugs reach
a wider audience.
And when the issue is weight loss, society is always
hungry for the next quick fix.
"My hesitation on something like this is that
people look at it as the answer to their problems. They
can do what they want, eat what they want, take this
pill and magically lose
weight," said Lana Koehler, founder of the
Stow-based Syndrome X Association, a foundation for
those dealing with insulin resistance and obesity.
"One of the difficulties of American society is,
we don't want to take responsibility for our actions,"
she said. "We want to take a pill."
Clinical trials of Acomplia followed 3,040 obese patients
at various sites in the United States and Canada over
two years, testing both the drug's safety and effectiveness
in helping people lose weight. Results - which were
released Tuesday at the heart association's meeting
in New Orleans - have yet to be published in a medical
journal.
Both Frazee and Koehler point out that little is known
about Acomplia's risks and side effects. It's also unclear
what kind of patients were enrolled, or more specifically,
what kind of patients were excluded because of certain
high-risk ailments.
Frazee said the preliminary results seemed to show
some neuropsychiatric side effects, including depression.
Even if that side effect shows up in only one in 10,000
patients, that translates into a large number of people
when millions of people start taking the drug.
"I think there are some significant concerns that
need to be pieced together a little bit better,"
he said. "If there's a cardiovascular risk, for
example, is it worth the risk of any adverse effects
if you're using it to cut a few pounds to fit into a
swimsuit?"
Kellie Watson's answer is no.
The Cuyahoga Falls woman was on fen-phen 10 years ago,
losing about 15 pounds in just two or three weeks. She
didn't have any heart problems, but the drug made her
hyper, unable to sleep, unable to concentrate. It wasn't
worth it. She got off fen-phen and gained the weight
back.
She's hoping Acomplia is as good as advertised - especially
for people like her who have battled their weight all
their lives.
For people suffering from insulin resistance, like
Watson, hunger cravings are a huge problem. Eating a
three-course meal does nothing to satiate them, because
their insulin levels are telling them to eat more.
"If they've found a way to curb cravings and hunger
pangs, it might be a really good thing," Watson
said.
Acomplia is part of an entirely new class of drugs,
Frazee said. It affects the cannabinoid receptor, a
pleasure receptor in the brain. This is the same biological
switch that makes people hungry when they smoke cannabis.
Another thing to keep in mind: What works for one patient
may not work for another.
"We're learning more and more that not all obese
patients are the same. You may have two people who are
both 50 pounds overweight but have very different issues."
Acomplia is not on the market yet. Its manufacturer,
Sanofi- Aventis, said it expects to seek approval from
the U.S. Food and Drug Administration in about a year.
Despite her concerns, Koehler said she's "cautiously
optimistic" that this new drug can do all it promises.
So is Frazee: "I think it seems like an exciting
drug."
Source:www.rednova.com
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