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U.S. Makes Progress in Preparing for Pandemic Influenza...But Drug Distribution and Effectivess are Debatable

P&T Journal, November 2007

The avian flu scare of a few years ago
has long since disappeared from
the headlines in the U.S., but its
legacy is still being felt in efforts at local,
state, and federal levels to put the country
on secure footing in case of a pandemic
influenza epidemic. No one is complacent,
especially since the deadly H5N1
strain of bird flu is apparently alive and
well in the Far East. China closed off one
village near Hong Kong in October after
10,000 ducks in the village died.
A question persists: How much prog -
ress have the Department of Homeland
Security (DHS) and the Department of
Health and Human Services (DHHS)
made in implementing an emergency
strategy and helping states, cities, and
counties develop an emergency response
capability? Not surprisingly, the answer is
mixed, according to hearings held in the
Senate Homeland Security and Governmental
Affairs Committee in October.
Homeland Security issued a plan in
March 2006, and the DHHS has been
busy implementing its overwhelming
share of the action items; at last count,
200 of them had been completed. Worried
about federal planning, Congress created
the position of Assistant Secretary for
Preparedness and Response in the Pandemic
and All-Hazards Preparedness Act
in December 2006, now filled by Rear Admiral
William Craig Vanderwagen, MD.
However, the federal lines of authority,
with respect to a pandemic influenza
emergency, are still unclear. Homeland
Security is responsible for the National
Response Plan (NRP), which is supposed
to be used as guidance at the local level for
response to all emergencies, whether it be
a Hurricane Katrina, a nuclear accident, or
an influenza outbreak. The department is revising and renaming the NRP, to be
called the National Response Framework.
The first draft of this plan, published this
past spring, was heavily panned.
In October, Yvonne Madlock, a Tennessee
public health official, stated:1
… we share the frustration of many local
and state officials about their lack of representation
in the revision process for the
National Response Plan, which will govern
response to pandemic influenza.
That lack of local input is evident in confusing
federal guidelines. In the same
presentation, she explained:1
For instance, recently released HHS/CDC
guidance for state and local preparedness
lists eight required critical tasks to prepare
for isolation and quarantine and [D]HHS is
working on performance metrics. DHS has
a published a Target Capabilities List for
Isolation and Quarantine that includes over
60 critical tasks, with associated performance
measures. The result is a mixed message
to local planners.
Beyond these kinds of guidance conflicts,
there are operational uncertainties
as well, foremost among them whether
localities will have enough of the right
anti viral agents on hand if an emergency
strikes and whether they will be able to
get them quickly enough to people who
need them.
Paul K. Halverson, Director and State
Health Officer of the Arkansas Department
of Health, said that even when a
state purchases antiviral drugs and stockpiles
them, it is still unknown whether
they will work. Moreover, millions of dollars
have been spent to purchase those
drugs, but the drugs cannot be used in
non-pandemic situations. If the drugs
have not been utilized at the end of five
years—at the end of their shelf life—they
are useless.
“There is no alternative offered to us
for rotation of this stockpile,” Mr. Halverson
added.The good news is that an adequate
stockpile (adequate treatment for 25% of
the U.S. population) of two neuram in -
idase inhibitors is nearly in place: osel -
tamivir phosphate (Tamiflu, Roche) and
zana mivir (Relenza, GlaxoSmithKline).
The federal stockpile provides 37.5 million
treatment courses, and the government
expects to purchase the remaining
12.5 million courses soon, after Congress
forks over the money, to achieve the goal
of 50 million—the 25%—by July 2008.
The states have bought about half of their
goal of 30 million courses of treatment,
and the DHHS is subsidizing those purchases
to the tune of $170 million.
Whether Tamiflu and Relenza will
work remains to be seen. Of course, it is
always possible that clinical resistance
to those two drugs will develop—hence
the efforts by the DHHS to develop a
third drug, peramivir, which is also a neuraminidase
inhibitor. Peramivir is in midstage
clinical evaluation.
“We need new antiviral candidates,
should the viruses become resistant to
the currently available antivirals,” admits
Dr. Vanderwagen.
Christopher Pope, Director of Home -
land Security and Emergency Management
in New Hampshire, offered the
clearest picture of our nation’s preparedness
for a pandemic influenza outbreak:2
Local governments, states, and the private
sector have made great strides in their preparedness
and response capabilities in public
health crisis. However, we are still not at
the acceptable level of readiness that our
citize ns expect and deserve. States and local
governments continue to need funding and
leadership from the federal government as
we continue to build these capabilities.