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The Battalion
ealth
fDA approves new obesity drug
eridia does not pose risk of heart valve damage, officials say
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^□WASHINGTON (AP) —The Food
Looking for ujd Drug Administration approved
| h month 0 (taifcW ^ rsl new obesity drug since a ban
r first two weeks* two popular diet remedies left
ly^ y^p-irweight Americans clamoring for
— but the new medicine poses
ijerious risk, too.
SKnoll Pharmaceutical’s Meridia
tohMi« moc j erate ly e ff ec ti ve ” a t helping
[tients shed pounds — in studies,
lylostabout? to 11 more pounds
Ian mere dieters, the FDA said
pnday.
But Meridia can cause increases
I blood pressure and pulse rate
(at may endanger certain patients,
He FDA warned.
I “We still have some concern,”
id FDA’s Dr. James Bilstad, who
ged doctors to rigorously check
tients’ blood pressure and pulse
and to prescribe it only to the se-
ijusly obese. “This drug should
litbe used for those who want to
se simply a few pounds.”
But the FDA said Meridia does
it appear to pose the risk of heart
Ive damage that forced Septem-
ir’s ban of the nation’s most pop-
ardiet drugs, Redux and fenflu-
mine, the “fen” in fen-phen.
The agency approved Meridia
iturday night over the objections
fits own scientific advisers, who
ilied the drug too risky.
But because of Meridia’s side ef-
cts, no one with poorly controlled
ypertension, heart disease or ir-
igular heartbeat or who has sur-
ived a stroke should use the drug,
leFDA cautioned. And it is only for
teseriously obese, as measured by
body mass index — the relation
ship of weight to height — of 30 or
greater, such as someone who is 5
feet, 6 inches and weighs 185
pounds.
Knoll pledged Monday to edu
cate doctors and patients to use
Meridia responsibly. “We are going
to actively discourage cosmetic use
of this medication,” said Carter Eck
ert, president of Knoll.
But Knoll cannot sell Meridia for
a few more months. The Drug En-
r Sales Befi
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Meridia Use
FDA cautions
patients with these
conditions:
hypertension
heart disease
irregular heartbeat
history of stroke
moderate obesity
HELEN CLANCY/The Battalion
forcement Administration is deter
mining how strictly to control pre
scriptions, after the FDA
determineu Meridia could pose a
small risk of addiction and recom
mended limiting refills unless pa
tients first return to a doctor.
Some 58 million Americans are
overweight, and obesity experts
welcomed Meridia as a desperately
needed option — particularly after
September’s ban of Redux and fen
fluramine.
“It’s great news for dieters,” said
Dr. John Foreyt of the Baylor Col
lege of Medicine.
But Foreyt said he hoped Sep
tember’s diet-drug scare had con
vinced dieters that Meridia is only
for the seriously obese. “It’s not to
be used willy-nilly,” Foreyt said.
Plus, Meridia “will not help in the
absence of changing your diet and
being a little more active.”
Consumer activists urged
Meridia users not just to see a doc
tor for regular blood pressure tests,
but to check themselves regularly
with an at-home blood pressure
monitor.
“If you catch a rise, you can stop
it” by simply stopping the drug, said
Lynn McAfee of the Council on Size
and Weight Discrimination. “Peo
ple have to be responsible about
this.”
Meridia, known chemically as
sibutramine, works a little differ
ently than fenfluramine and Redux
did. They fooled patients into feel
ing full by boosting production of a
brain chemical called serotonin.
Meridia, on the other hand, slows
the body’s dissipation of the sero
tonin it naturally produces.
But doctors don’t know why
Meridia would raise blood pressure
— especially if patients lost weight.
On average, Meridia patients’ blood
pressure increases two to three
points and their pulse speeds up
four to five beats a minute.
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commission
lacks use of
dietary labels
WASHINGTON (AP) — Makers of di
etary supplements should use science to
Jack claims that their products actually
lelp people’s health, a presidential com
mission said Monday — but it backed off
11 forcing companies to submit evidence to
the government.
Ultimately, consumers will have to do
their own homework before buying sup
plements to make sure they’re not wast
ing their money, the Commission on Di
etary Supplement Labels concluded.
“It behooves the public ... to do a fair
amount of investigation on their own,” said
panel chairman Malden C. Nesheim, pro
fessor of nutrition at Cornell University.
The commission issued its final report
Monday on how a 1994 law should be im
plemented. It recommended that nutri
tional claims be “supported by scientifi
cally valid evidence.”
It urged manufacturers to make that
evidence available publicly, but commis
sioners dropped a recommendation in
their draft report calling for companies to
submit a summary of evidence to the
Food and Drug Administration.
Industry officials complained that the
law does not require them to submit this
information, Nesheim said, and they said
disclosing it could help their competitors.
He said consumer groups also com
plained that it could look like companies
had some sort of FDA approval when, in
fact, they did not.
Responsible companies will supply the
information to consumers who ask for
proof that their products actually work,
Nesheim said.
“Informed and interested consumers
ought to start asking for that,” he said.
The law requires manufacturers to as
sure dietary products are safe, and it
spells out what claims can be made on
labels and how these claims must be
backed up.
But it allows manufactures to sell these
products without any outside experts or
scientists evaluating them first. Under the
law, the FDA acts only if trouble is sus
pected.
The report is now in the hands of Don
na Shalala, the secretary of Health and
Human Services, who has 90 days to de
cide whether to propose the recommen
dations as formal rules.
The commission also recommended:
—The FDA be given more money to
identify and investigate supplements that
pose hazards. “There must be a strong and
reliable enforcement system,” it said.
—Dietary health claims on the labels of
supplements should be based on the
same “significant scientific agreement”
that is required for conventional foods.
The industry consider establishing a
scientific committee to review labels.
The FDA establish a panel to review
herbal products that companies wish to
market as preventive and therapeutic.
—Specific guidelines for the content of
labels including warnings when appro
priate and guidance on using terms such
as “stimulate” and “promote.”
The FDA had no comment on the re
port Monday.
Experimental brain cancer
surgery shows potential
NEW YORK (AP) — An ex
perimental treatment that
tricks tumors into swallowing
poison has shown promise in
brain cancer patients.
The therapy shrank tumors
by at least half in nine of 15 pa
tients. In one of those patients,
the cancer disappeared for five
months before reclining; in an
other, it was gone for nearly two
years before returning.
“We haven’t cured anybody,
and it’s not likely we can at this
point” because it’s too early in
the treatment’s development,
said Richard J. Youle of the Na
tional Institute of Neurological
Disorders and Stroke.
The small study, which was
designed to look for side effects
rather than test the treatment’s
effectiveness, is reported in the
December issue of the journal
Nature Medicine. In an accom
panying editorial, Dr. Robert
Martuza of the Georgetown Uni
versity Medical Center called the
result impressive but stressed
that it must be confirmed by fur
ther work.
Nearly all the cancers in the
study originated in the brain,
rather than migrating from else
where in the body. About 18,000
Americans are expected to get
cancers arising in the brain this
year; less than half will be of the
types treated in the study.
The patients had recurring,
growing brain cancers that had
n’t been cured by standard ther
apy.
The experimental treatment
took advantage of brain cancer’s
appetite for iron. To attract iron,
tumor cells sprout chemical
hitching posts that grab trans
ferrin, a substance that shutdes
iron in the brain.
For the treatment, re
searchers yoked molecules of
transferrin to molecules of diph
theria toxin. The toxin was al
tered so it would not harm nor
mal cells, but it would still poison
cancer cells that sucked it in with
the transferrin.
Child psychologists urge
special treatment for
sister of Iowa septuplets
DES MOINES, Iowa (AP) —
When Mikayla McCaughey got a
peek at her tiny brothers and sis
ters in the intensive care unit,
she saw only a lot of babies —
not seven instant rivals for Mom
my and Daddy’s attention.
For the first 21 mondis other
life, the family revolved around
Mikayla, then the only child of
Bobbi and Kenny McCaughey.
But before Mikayla turns 2, four
little brothers and three sisters—
all born last Wednesday —
should be home from the hospi
tal.
“I tell my patients that it
would be like a husband bring
ing home a much younger, very
attractive woman and telling his
wife, ‘Look at how beautiful she
is, how warm and wonderful.
Now I expect you to love her and
be nice to her,’” said child psy
chologist Alice Sterling Ho nig of
Syracuse University.
Child psychologists say the
McCaugheys must be careful not
to get so busy with the septuplets
that they ignore Mikayla.
Nancy Segal, a psychology
professor at California State Uni
versity-Fullerton and director of
the school’s Twin Studies Center,
said litde research has been done
on the effects of multiple births
on older siblings, but mishan
dled relationships can lead to re
sen Unent, withdrawal and anger
toward the parents and brothers
and sisters.
“What happens is that people
in their great excitement at a
multiple birth begin to lavish at
tention on the multiples and re
ally tend to exclude that older
child,” Ms. Segal said.
McCaughey said last week
that his oldest child was thrilled
when she first saw the family’s
new additions. “I brought her
down yesterday and she just
kind of sat there in my arms and
said; ‘Baby! Baby!”’ he said.
But the McCaughey family
has said that Mikayla does not
yet understand that the seven
babies are her parents’ and that
they eventually will come home.
Six were in serious condition
Monday; one was in fair condi
tion.
The family has made sure to
focus attention on Mikayla and
involve her when gifts are given,
said her aunt, Michele Hep-
worth, who has cared for Mikay
la since Mrs. McCaughey was
confined to bed nine weeks into
the pregnancy.
When the family was given a
new van, Mikayla’s name was
written on the side along with
those of her brothers and sisters.
When Gov. Terry Branstad stood
with the family to talk about do
nations for a new house, he had
a stuffed Winnie the Pooh for
Mikayla.
“She’s going to be a wonder
ful big sister,” Ms. Hepworth
said. “She loves to play with baby
dolls all the time, cradles them
and puts them to sleep.”
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MAN
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