Download - Kuwait Times

SATURDAY, FEBRUARY 25, 2012
MUMBAI: A child cries while being administered polio drops by a
health worker during a door-to-door immunization drive in
Mumbai yesterday. India celebrated a full year since its last
reported case of polio last month, a major victory in a global
eradication effort that seemed stalled just a few years ago. — AP
Eating citrus lowers
women’s stroke risk
WASHINGTON: Women who regularly eat citrus fruits such as
oranges and grapefruit may have a lower risk of blood-clot related
stroke, according to a US study published on Thursday.
Researchers looked at 14 years of data from a US nurses survey
that included 69,622 women who reported what they ate,
including details on fruit and vegetable consumption, every four
years. The aim was to study the effects of flavanoids-a class of
compounds present in fruits, vegetables, dark chocolate and red
wine-on health. While total flavanoid consumption across all six
main types found in the typical US diet did not show a benefit in
preventing stroke, those who ate lots of orange and grapefruit
and their derived juices showed a 19 percent lower stroke risk
than their counterparts in the study.
SILVER SPRING: A previously rejected weight loss pill won an
overwhelming endorsement from public health advisers
Wednesday, raising hopes that the drug from Vivus Inc could
become the first new anti-obesity medication to reach the US
market in more than a decade.
The Food and Drug Administration has rejected three weight
loss pills in the last two years, including Vivus’ pill Qnexa, due to
safety concerns. Experts agree new weight loss drugs are needed
to treat an estimated 75 million obese adults in the US, but the
string of rejections has raised questions of whether any pharmaceutical
treatment is safe enough to win approval. At a public
meeting Wednesday, an FDA panel of outside physicians voted
20-2 in favor of the weight loss drug from Vivus, setting the stage
for a potential comeback for a drug that has been plagued by
safety questions since it was first submitted to the agency in 2010.
Nearly all the panelists backed the drug due to its impressive
weight loss results, with most patients losing nearly 10 percent of
their overall weight after a year on the drug. But the group
stressed that the drugmaker must be required to conduct a large,
follow-up study of the pill’s effects on the heart. Studies of Qnexa
show it raises heart rate and causes heart palpitations, a longtime
concern with diet pills over the years. The group of experts said it
is still unclear if those side effects lead to heart attack and more
serious cardiovascular problems.
“The potential benefits of this medication seem to trump the
side effects, but in truth, only time will tell,” said Dr. Kenneth
Burman of the Washington Hospital Center. The FDA is not
required to follow the advice of its panels, though it often does. A
final decision on the drug is expected by mid-April.
WASHINGTON: For nearly a century, scientists
have struggled to make a diet pill that
helps people lose weight without side
effects that range from embarrassing digestive
issues to dangerous heart problems.
But this week, US federal health advisers
endorsed the weight loss pill Qnexa even
though the FDA previously rejected it over
concerns that it can cause heart palpitations
and birth defects if taken by pregnant
women. The vote of confidence raises
hopes that the US could approve its first
anti-obesity drug in more than a decade. It
also highlights how challenging it is to create
a pill that fights fat in a variety of people
without negative side effects.
“Having a drug for obesity would be like
telling me you had a drug for the fever,” said
Dr. Mitchell Roslin, chief of bariatric surgery
at Northern Westchester Hospital in New
York. “There can be millions of different reasons
why someone is obese; it’s really a
symptom of various underlying mechanisms.”
An effective and safe diet pill would be
an easy sale in the US with more than 75
million obese adults, the nation’s obesity
rate is nearing 35 percent. But the biggest
problem in creating a weight-loss drug is
that there’s no safe way to turn off one of
the human body’s most fundamental directives.
For millions of years, humans have been
programmed to consume calories and store
them as energy, or fat. It’s this biological
mechanism that makes it almost impossible
to quickly lose weight by not eating. Cutting
down on food instead sends stronger signals
to the body to store more calories.
“Throughout most of human history
calories were scarce and hard to get, so
we have numerous natural defenses
against starvation,” said Dr. David Katz of
Yale University’s Prevention Research
Center. “We have no defenses against
overeating because we never needed
them before.”
The drug industry has been on a nearly
100-year search for a drug that can help the
body shed pounds. They’ve mostly failed to
come up with an effective one and many of
their experiments have proven fatal to
patients: Early attempts focused on speeding
up metabolism to burn more calories. In
the 1930s, doctors prescribed an industrial
chemical called dinitrophenol, which accelerated
metabolism, but also caused fever,
swelling and deadly toxicity in some
patients. The 1938 law establishing the
Food and Drug Administration was a
response to untested drugs like dinitrophenol.
In the ‘50s and ‘60s, amphetamines
became a popular because they boost
metabolism and suppress appetite. But the
pills proved to be highly addictive, and doctors
discovered they increase blood pressure
and heart rates. The amphetamine
phentermine remains approved for shortterm
weight loss, usually less than 12 weeks,
though it is seldom prescribed because of
the potential for addiction. Perhaps the
worst diet pill safety debacle came in the
1990s and involved the combination of
phentermine and another weight loss drug
marketed by Wyeth called fenfluramine. The
combination of the two pills, dubbed fenphen,
was never approved by the FDA but
more than 18 million prescriptions were
written for it by the mid-90s.
But after studies in 1997 suggested that
up to a third of patients taking fen-phen
experienced heart valve damage, Wyeth
was forced to recall two versions of fenfluramine
and eventually paid more than $13
billion to settle tens of thousands of person-
HEALTH
Miracle diet pill? A
safe drug is elusive
US health advisers endorse weight loss pill
In a key question, the physicians said Vivus could conduct the
cardiovascular safety study after FDA approval. A requirement to
conduct the study ahead of market approval would cost the company
millions of dollars and take at least three more years. “There
is an urgent need for better pharmacologic options for individual
patients with obesity,” said Dr Elaine Morrato, of the University of
Colorado. “I believe Qnexa demonstrated a meaningful efficacy
benefit and that there are consequences to not treating obesity.”
Vivus, based in Mountain View, Calif., is one of three small
drugmakers racing to bring the first new prescription weight loss
al injury lawsuits. In the last decade, drugmakers
have moved toward other weight
loss concoctions.
Currently, the only drug approved for
long-term weight loss in the US is orlistat,
which is sold as the prescription drug
Xenical and over the counter as alli. The
drug works by blocking the absorption of
fat.
When launched in 2007, alli received a
high-profile marketing push from drugmaker
GlaxoSmithKline, complete with TV ads
and a celebrity endorsement by country
singer Wynonna Judd. But it never took off
due to unpleasant side effects, including
loose bowel movements. Educational pamphlets
for alli even recommend people start
the program when they have a few days off
work, or bring an extra pair of pants to the
office. Most drugmakers now are focusing
on medications that block brain signals
associated with food craving and appetite.
Vivus’ Qnexa is one of a trio of drugs seeking
FDA approval. The diet pill, which was initially
rejected due to the risks of heart palpitations
and other safety issues, is a combination
of two older drugs.
It uses amphetamine phentermine,
which suppresses appetite. The other drug
is topiramate, an anticonvulsant sold by
Johnson & Johnson as Topamax.
Topiramate is believed to make patients feel
more satiated, though it’s unclear exactly
how. J&J initially studied Topamax alone as
a weight loss treatment but concluded the
psychiatric side effects, such as memory loss
and difficulty concentrating, were too significant.
Still, on Wednesday, a panel of FDA doctors
and other advisers voted 20-2 in favor
of approving Vivus’ Qnexa pill, which the
drugmaker has resubmitted to the FDA for a
second review. — AP
FDA panel approves rejected obesity pill
drug to market in more than a decade. In the past two years the
Food and Drug Administration has rejected pills from all three:
Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus.
All three companies are in the process of resubmitting their products.
The FDA rejected Qnexa in October 2010, citing numerous
side effects including elevated heart rate, psychiatric problems
and birth defects. Vivus has resubmitted the drug with additional
follow up information on safety, hoping for a more favorable ruling.
Vivus President Peter Tam said the overwhelming panel vote
Wednesday indicates doctors recognize the urgent need for
effective weight loss drugs. “Right now there aren’t any good
treatments out there besides dieting and bariatric surgery - clearly
there’s a huge gap,” Tam said.
With US obesity rates nearing 35 percent among adults, doctors
and public health officials say new weight-loss therapies are
desperately needed. And even a modestly effective drug could
have blockbuster potential. Analysts expect a new weight loss pill
to garner at least 10 million users within a few years.
Qnexa is a combination of two older drugs: the amphetamine
phentermine, which is approved for short-term weight loss, and
topiramate, an anti-seizure and anti-migraine drug sold by
Johnson & Johnson as Topamax. Phentermine helps suppress
appetite, while topiramate is supposed to make patients feel
more satiated. Along with heart safety, panelists raised concerns
about potential birth defects in women who become pregnant
while taking Qnexa: topiramate is known to more than double the
risk of birth defects. There were 34 pregnancies among 3,386
women enrolled in Vivus’ studies of Qnexa, despite precautions to
make sure women used contraception. —AP