C4
The Daily Commercial
Monday, September 14, 2009
SWINE FLU
ALLI
From C1
From C2
liver toxicity more than a year ago, but
company executives said they had no
advance warning of the August
announcement.
“I think it’s fair to say we would
have liked to have had some advance
notice of this, because we were forced
into a position where we had to
respond very quickly,” said Roger
Scarlett Smith, president of Glaxo’s
Pittsburgh-based consumer product
division.
FDA spokeswoman Siobhan
Delancey said the agency never gives
early notice of such actions.
“Many of these actions have the
potential to significantly affect stock
prices, and to provide advance warning may give certain investors an
unfair advantage,” Delancey said in a
statement.
Glaxo is not the first drugmaker to
be caught off guard by so-called early
communications, which the FDA first
implemented in 2007.
The FDA has since issued early com-
munications on a slew of drugs,
including Merck’s asthma drug
Singulair and Pfizer’s smoking-cessation pill Chantix. The agency ultimately added a “black box” warning to
Chantix and bolstered language about
suicidal behavior, depression and anxiety on Singulair.
The FDA implemented the new policy after coming under fire for acting
too slowly on problems with blockbuster drugs like Merck’s painkiller
Vioxx, which was linked to heart
attack and stroke after approval.
Mark Senak says any company regulated by the FDA should expect to see
earlier action as Obama administration
officials begin sharpening their focus
on protecting public health.
“I think this is just part of the bigger
picture of moving the agency to a
more pro-active public health stance,”
said Senak, an attorney who advises
companies as a consultant for communications firm Fleishman-Hillard.
The FDA said last month it had
received 32 reports of serious liver
injury among patients taking alli and
Xenical between 1999 and October
2008. Twenty-seven patients had to be
hospitalized, and six of those suffered
liver failure.
The FDA release did not mention
that only two of the 32 reports
involved alli, something Glaxo and the
FDA later confirmed. Xenical, which is
marketed by Roche, has been available
via prescription for 10 years.
Glaxo stresses that more than 6 million people in the U.S. have taken the
drug, making two incidents of liver
damage a micro-fraction of a percent.
Executives also note that as many as
20 percent of overweight people
already have liver damage, due to
excess fat in the organ.
The FDA has not set a deadline for
concluding its investigation, but has
advised patients to continue taking the
drugs as directed.
Hearing Loss is the
third most common
chronic ailment
besides Hypertension
and Arthritis.
People go to their
primary physician
to find out what to
do about their
hearing health
care needs.
Anthony Fauci, director of
the National Institute of
Allergy and Infectious
Disease.
He said the tested vaccines
were made by Sanofi Pasteur
and CSL Ltd. and both produced “robust” immune
responses.
In people aged 18 to 64,
96 percent had a strong
response to the Sanofi version and the response was
80 percent for CSL. Fauci
played down the difference,
noting the tests were done
after only eight to 10 days
and immune response could
be the same in both groups
as it increases after that
point.
In addition, there were no
significant side effects, Fauci
said.
People over 65 did not
respond as strongly, but still
got enough of an immune
reaction that they should
seek out the shots when
their turn comes, officials
said.
First on the list for the
swine flu shots, however, are
children and young adults,
pregnant women and others
with health problems, since
the H1N1 flu seems to strike
them more often.
Older people are more at
risk from the regular seasonal flu and — along with
other people — should get
those shots now, Sebelius
said.
She noted she got her own
seasonal flu shot Friday at a
school in nearby Alexandria,
Va.
Why bother with the seasonal shot, since nearly all
the current flu cases are
swine flu?
“The fact that the (seasonal) virus is not circulating
now is absolutely no reason
not to get vaccinated,” Fauci
said. “You would hope that
you would get vaccinated
before the seasonal flu is circulating so you will have an
immune response.”
Fauci said it still appears
the bulk of the swine flu
vaccine will be available in
mid-October, though there is
a possibility some may be
available sooner, “we hope.”
“The disease is increasing
already and it is still a bit of
a race to get the vaccine out
there ahead of the disease,”
Schuchat said.
Even with the swine flu
spreading now there will still
be plenty of need for the
vaccine, the officials
stressed.
One dose means tight supplies of H1N1 vaccine won’t
be stretched so thin after all.
The U.S. has ordered 195
million doses, based on the
hope that 15 micrograms
was indeed the right dose.
Had it taken twice that
dosage, or two shots apiece,
half as many people could
have received the vaccine.
MINNESOTA
From C1
Four out of five doctors recommend
their patients seeing an Audiologist.
VISIT LAKE COUNTY HEARING’S
DOCTORS OF AUDIOLOGY OR
AUDIOLOGISTS TODAY!
“We are always prepared to make you hear your very best. That is
why you will only be seen by our university trained Doctors of
Audiology and AudiolOgist.”
“Our goal is to honestly inform and educate you about your particular hearing loss and what options you have available. It is not just
to sell you something. We truly care about helping you hear and can
provide you with the most advanced hearing technologies available
that will fit within your budget.”
James Davenport, Au.D.,
& Associates of Lake County Hearing
Hearing Aids are one of the most important investments
you can make for yourself and we want to help you
protect them against moisture damage.
get diabetes, heart disease and some cancers. Providers lose
money on Medicare and Medicaid patients. And in the face
of budget problems, the state plans to cut off subsidized coverage for more than 30,000 low-income adults next year.
Republican Gov. Tim Pawlenty, who is positioning himself
for a presidential run in 2012, said Obama has focused too
much on expanding public coverage without enough
emphasis on controlling costs. The governor has pushed to
reduce Minnesota’s public programs during his two terms;
he said Thursday that the state can’t afford those programs.
“We’ve been viewed as one of the most aggressive and
impactful states when it comes to reform and change and
improvement in health care, but our view of that is that it
needs to be less government-centric,” he said at a Capitol
news conference.
Pawlenty’s administration is implementing a 2007 state
law designed to create “medical homes,” designated
providers patients can call around the clock to guide them
to the appropriate place for care and, ideally, reduce costly
emergency room visits and duplicative care.
The state also is taking steps toward paying providers
based on how well their patients do, although that’s still a
way off.
State Rep. Tom Huntley, a Democrat from Duluth and one
of the state’s health care experts, advocates paying providers
for keeping patients in good shape instead of mainly covering operations and hospitalizations.
Park Nicollet Health Services in St. Louis Park, Minn., is
attempting this as part of a federal pilot program. The
health system monitors 400 congestive heart failure
patients, using daily reports that the patients make from
home to try to prevent unnecessary hospitalization where
cheaper care — or simply a conversation with a nurse — is
appropriate.
The project has cut hospitalizations in half, saving
Medicare more than $3 million. But Park Nicollet estimates
it has missed out on about $6 million in revenue over three
years.
“If there was a payment system that supported this, the
country could save literally billions of dollars on just this
intervention for patients with congestive heart failure,” said
Dr. David Abelson, Park Nicollet’s chief clinical officer and
president.
Right now you will receive a FREE
Zephyr Dry & Store Unit with the purchase of
any Binaural Set of Hearing Aids*, the most effective
drying technology for hearing instruments of all types.
Units are also available for sale even if you purchased
your hearing aids elsewhere.
FIRST VISIT FREE
(Except Emergencies)
ESTIMATE, EXAM DO140, X-RAYS, DO272,
SECOND OPINION, CONSULTATION
*Prior purchases and trial period fittings excluded.
FREE 3 Year Warranty! FL State Trial Period For Everyone.
NEW PATIENT OFFER
Full Diagnostic audiological hearing exam with Primary Care Physician referral.
Not just a screening for the sale of a hearing aid!
Visit any one of our convenient locations and find out
which appropriate hearing aid system is right for you!
James Davenport, AuD.
Doctor of Audiology
A.T. Still University Arizona
Sheryl Mendez, M.S. CCCA
Clinical Audiologist
Florida State University
399
$
Each
(3 or more per visit)
D2751/Reg. $535 ea.
Porcelain on non
precious metal
$55
Reg.
$135
Cleaning by FL
Licensed Hygienist.
All necessary X-rays.
Exam by doctor.
Now Accepting
Care Credit
999
$
Each
(3 or more per visit)
D6010
Reg. $1,400 ea.
Expires 9/30/09
Megan L. Stout, AuD.
TAVARES
352-343-4488
LADY LAKE
352-750-4327
CLERMONT
352-243-1212
Waterman Medical Plaza Hwy. 441 - The Villages 235 Citrus Tower Blvd., Suite 106
(La Plaza Grande W.
(Between Blockbuster
(New Hwy. 441)
Next To Publix)
& Citrus Tower)
www.lakecountyhearing.org
Doctor of Audiology
Nova Southeastern University
Dane Bowers, AuD.
Doctor of Audiology
University of Tennessee
SUNRISE DENTAL
TRI DENTAL
1380 N. Blvd. W.
Leesburg
18515 Hwy. 441
Mt. Dora
326-3368
383-5377
The patient and any other person responsible for payment has the right to refuse to pay, cancel payment or be reimbursed for payment for any other
services, examination which is performed as a result of and within 72 hours of responding to the advertisement for the discounted fee or reduced fee
service or treatment. Fees may vary due to complexity of case. This discount does not apply to those patients with dental plans. Fees are minimal.