WSJ(10/6) US Sees Need To Better Prepare Against Avian Flu
06 Oct 00:00
(From THE WALL STREET JOURNAL)
By Bernard Wysocki Jr.
WASHINGTON -- Amid growing concerns about bird flu spreading to humans, the
Bush administration says it plans to bolster vaccine production in the U.S.,
purchase huge quantities of antiviral drugs and lay out a detailed system to
coordinate federal, state and local response efforts to a pandemic.
In an interview, Health and Human Services Secretary Michael Leavitt said an
administration plan to be put forth in coming weeks is designed to ensure a far
more robust domestic vaccine industry, with expanded U.S. manufacturing
capacity. White House and congressional officials have said the request to
Congress will be in the range of $6 billion to $10 billion.
The U.S. once boasted a large vaccine industry. But in recent decades drug
makers have exited the business, for reasons including low profit margins,
exposure to lawsuits and manufacturing difficulties. As a result, the U.S. has
lost much of its capacity to produce vaccines for seasonal flu, leaving it
largely dependent on a plant in Pennsylvania, which is owned by Paris-based
Sanofi-Aventis Group.
Increasingly, bird flu, or avian influenza, has stoked worries among world
health officials of a global pandemic as it has devastated poultry flocks and
Asia and begun spreading to migratory birds and humans. Since late 2003, more
than 60 human deaths in Asia have been blamed on the current strain of the flu,
known as H5N1.
Adding to the concerns, a group of scientists yesterday said they had shown
that the 1918 Spanish flu epidemic blamed for 50 million deaths had started
among birds and then mutated and spread to humans.
Researchers said the discovery, while frightening in its implications, also
could help researchers track and perhaps contain a major outbreak. "We have
been able to unmask the 1918 virus, and it's revealing to us some of the
secrets that will help us prepare for a pandemic," said Julie Gerberding,
director of the Centers for Disease Control and Prevention.
That process is very much a work in progress, officials admit. "We are not
prepared for a pandemic, and it is important that we become prepared," said Mr.
Leavitt, who has become the administration's point person on the subject,
immersing himself in the issue and in the history of pandemics. "Pandemics
require the full measure of our attention. We have to improve our readiness."
There remains considerable uncertainty about a possible pandemic. It's
unclear whether human-to-human contact of the virus ever will be widespread.
Even if that happens, advance preparations could be effective or futile
depending on how the virus mutates. Mr. Leavitt noted that he had studied
carefully the swine-flu episode of 1976, which despite widespread fear, didn't
turn into a devastating killer.
Efforts to develop a vaccine for the H5N1 strain are continuing. In August,
the National Institutes of Health reported that the first human trials of an
avian-flu vaccine made by Sanofi-Aventis were effective.
But at the time, Dr. Anthony Fauci, director of the National Institute of
Allergy and Infectious Diseases, cautioned that many hurdles remain before a
vaccine will be available for widespread use, including producing enough to
meet potential demand.
The administration already has received much attention for its effort to have
20 million treatments of an avian-flu vaccine stockpiled and on hand to
inoculate U.S. citizens. Sanofi-Aventis has received six contracts to develop
and manufacture some quantity of its vaccine, including a $100 million award in
September to bolster the manufacturing capacity for avian-flu vaccine in the
U.S.
Mr. Leavitt didn't discuss many other details of his plan, but said he plans
to put in place a comprehensive surveillance system to track the pandemic. He
is traveling to Southeast Asia next week to countries grappling with the flu.
In the wake of criticism over its response to Hurricane Katrina, the
administration is taking pains to highlight its efforts to prepare for a
possible pandemic. In recent days, several prominent Democrats have accused the
White House of failing to prepare for a pandemic. President Bush spoke at
length on pandemic flu plans during a news conference Tuesday, discussing a
possible quarantine of citizens -- perhaps even using the military -- and
saying he is in touch with NIH.
Besides Sanofi-Aventis, a number of big drug companies could benefit from the
expanded effort being pushed by the administration and Congress. Switzerland's
Roche Holding AG, for instance, has received orders from more than 30 countries
for treatments of Tamiflu, an antiviral medicine that is in high demand but
short supply. Most of the big orders would be staggered over two to three
years, analysts say.
The administration also plans to buy 20 million doses of Tamiflu for the
U.S., though Mr. Leavitt wouldn't specify how or when they would be available.
Today, the U.S. has enough Tamiflu on hand to treat 4.3 million people. (The
department also recently agreed to spend $2.8 million for quantities of another
antiviral made by GlaxoSmithKline.)
There has been some controversy around Tamiflu, and Mr. Leavitt, a former
three-term governor of Utah and ex-head of the Environmental Protection Agency,
said he considered purchasing the drug to be akin to an automobile seat belt.
"It doesn't eliminate wrecks but it helps you survive when they occur," Mr.
Leavitt said. He said he was aware about recent scientific reports suggesting
that Tamiflu might be only modestly effective against the H5N1 virus.
Roche doubled manufacturing capacity of Tamiflu in 2004 and again in 2005 and
said it will further increase manufacturing capacity in 2006. "We're bringing
manufacturing capacity to the U.S. for the first time at a number of
facilities," said spokesman Terence Hurley. "We'll now have the capability to
produce Tamiflu from start to finish for the first time on U.S. soil this
quarter. That's important if borders are closed; HHS asked us to do this."
Indeed, Mr. Leavitt said there needs to be a focus on producing vaccines in
the U.S. so as to potentially prevent the infection instead of treating those
already infected. Today, the only major flu-vaccine manufacturing facility in
the U.S. is the Swiftwater, Pa., plant owned by Sanofi-Aventis, which produces
seasonal flu vaccines.
One U.S. company, Emoryville, Calif.-based Chiron Corp. produces flu vaccine
for the U.S. at a United Kingdom plant, although that supply was curtailed last
year after contamination problems surfaced at the plant. In addition, MedImmune
Inc., of Gaithersburg, Md., produces an inhaled flu vaccine, for healthy people
ages 5 to 49. Last week, MedImmune said it will work with NIH to develop a
vaccine to be used against strains of influenza that could cause widespread
outbreaks, including avian flu that has appeared in Southeast Asia.
Though infectious diseases are huge killers, with about 35,000 to 40,000
Americans dying each year from seasonal flu, big drug companies are largely
ignoring investing in vaccines. Instead, they are placing their bets on chronic
diseases or on lifestyle drugs with big profit potential, resulting in a
growing public-health problem.
HHS officials warn that tight vaccine supply could be further strained if
needs for seasonal flu occur at the same time a pandemic requires huge extra
production to meet a crisis. Experts also say a beggar-thy-neighbor policy
could occur in a crisis, in which governments "nationalize" their supplies, so
that non-U.S. production would quickly be grabbed by those countries and
unavailable outside their borders.
Congress already has been taking up the U.S.'s lost vaccine production
capacity. A bill introduced this summer by Sen. Judd Gregg, a New Hampshire
Republican, would give liability protection to drug companies that produce
either biodefense drugs or countermeasures to combat pandemic flu. Other plans
would give tax breaks to companies that make vaccines. Some members of Congress
are proposing laws that would offer the same incentives for companies to
develop countermeasures against either man-made or naturally occurring
pathogens such as flu.
An important part of the government's plan, Mr. Leavitt said yesterday, is to
clearly delineate the roles of federal, state and local officials in the event
of a pandemic crisis -- a source of much contention in the response to
Hurricane Katrina.
"What if this were happening in Seattle and Portland, Maine, and Chicago and
Omaha and Santa Fe and Miami and Austin and Salt Lake City and 500 other places
-- all at the same time?" Mr. Leavitt said. He said that response would have to
be managed by local public-health authorities, not by the CDC, which is based
in Atlanta.
He also said, though, that state and local preparations need bolstering,
quickly. Last December, Trust for America's Health, a nonprofit advocacy group
based in Washington, concluded that only six states had achieved "green" status
for the Strategic National Stockpile, meaning they were adequately prepared to
distribute vaccines and antidotes in an emergency. It found that two-thirds of
the states can't track diseases electronically and 60% of states don't have the
scientists needed to test for anthrax or plague.
---
Marilyn Chase contributed to this article.
(END) Dow Jones Newswires
10-06-05 0000ET
Copyright (c) 2005 Dow Jones & Company, Inc.
