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Tick. Tick. Tick.

Thursday, March 16, 2006  |  posted by Hugh Hewitt

With this announcement, state and local governments have no excuse not to prepare for H5N1’s arrival in the U.S.:

6 a.m.: Roche Holding said it has greatly increased its capacity to produce antiviral drug Tamiflu, but that government orders to stockpile it were lagging far behind. “Our capacity is well in excess of all government orders that we have received to date,” said William Burns, chief executive of the Roche Pharma unit. “We stand ready. There should be no holding back.” The drug is regarded as the best initial defense against a pandemic resulting from a mutation of the bird-flu virus.

On Monday, HHS released a comprehensive update on avian flu preparedness, which included this section on the stockpiling of antivirals:

Antivirals are drugs that lessen the impacts of flu. There are currently two FDA-approved antivirals that have shown effectiveness against the H5N1 virus, Tamiflu, and Relenza. Both must be taken within 48 hours of the onset of flu symptoms. (Note that there are two other approved flu antivirals, but CDC studies show H5N1 to be resistant to them.)

We are building a national stockpile of these two antivirals. The immediate goal is to stockpile enough antivirals to treat 20 million people. The longer- term goal is to be able to treat 75 million people, or 25 percent of the U.S. population. Achieving this goal depends on future pandemic flu appropriations, manufacturing capacity and participation by the states.Because Tamiflu is also approved for prevention, treatment for an additional 6 million people is also being stockpiled. This will be used in an effort to help contain a first outbreak of potential-pandemic influenza. The concept is to blanket the area of the initial outbreak, giving Tamiflu to as many people as possible to prevent the flu’s spread before it gets out of control. In March, HHS purchased more than 14 million courses of Tamiflu and Relenza, which will increase the national inventory to nearly 20 million courses. The total targeted stockpile is 81 million courses by the end of 2008. HHS will purchase 50 million out right and subsidize (by 25 percent)
the states’ purchase of 31 million courses. (A course is the number of
doses needed to treat one person ‘” ten capsules in the case of Tamiflu.)

Antivirals will be distributed among the states and territories on a per-capita basis. FDA is monitoring Tamiflu shipments to identify potential counterfeits, and is actively investigating companies selling fraudulent, unapproved influenza products.

Given the availability of the drug for prepurchase by state and local governments, an arrival of H5N1 that is not immediately countered by the distribution of Tamiflu to first responders and care-givers in order to prevent their infection will be a failure by the state and local government –not the federal government. As the report explains:

It is not enough to stockpile antivirals; there needs to be a plan to distribute them. HHS is discussing with the states whether the antivirals should be centrally located or warehoused locally. To receive funding, states are being required to develop distribution plans now, so that if a pandemic erupts, it will be clear where the drugs are to go and how they will get there.

Here’s the kicker:

An influenza pandemic is likely to occur almost simultaneously across countries and communities. It will demand that every aspect of our communities be self-sufficient, able to deal with the outbreak of illness should it hit. Political leaders, employers, school leaders, healthcare leaders, faith-based and community organizations, families and the media must all be informed, engaged, and actively involved.

Step one: Plan for the arrival of the virus by determining where patients will be cared for and by whom.

Step two: Stockpile Tamiflu.

Every state and local government that has not doe both of these steps is failing in its primary responsibility to protect the health and welfare of its people.

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