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Schumer Reveals: Feds Have Reneged On Their Commitment To Provide Adequate Tamiflu Stockpiles

HHS Is Planning to Purchase Tamiflu for Far Fewer Than the 100 million Americans that Need to Be Protected Against Bird a Potential Flu Pandemic

With Roche Living Up to Its Promise to Dramatically Increase Production Capacity, Schumer Calls on HHS to Make Good on its Commitment to Stockpile Enough Tamiflu for Americans

Today U.S. Senator Charles Schumer revealed that the federal government has reneged on its commitment to provide enough Tamiflu stockpiles to safeguard Americans from a potential bird flu pandemic. Schumer sent a letter to Michael Leavitt, Secretary of the U.S. Department of Health and Human Services (HHS), urging him to dramatically increase stockpiles for Tamiflu, the only antiviral currently available to treat Bird Flu. Schumer has been a leader in getting Roche Pharmaceuticals, the manufacturer, to increase Tamiflu production capacity and he has repeatedly urged the Federal government to stockpile enough of the bird flu antiviral treatment to cover at least 100 million Americans, which is how many people experts tell us the government should stockpile the treatment for. Schumer also helped to secure over $2 billion in federal funding for HHS specifically for pandemic preparations, but HHS has spent only a very small portion of those funds to stockpiling Tamiflu, leaving millions of Americans unprotected.

Schumer said, The bottom line is that the Feds are falling way short of their commitment to protect Americans from a bird flu pandemic. HHS needs to significantly boost its Tamiflu orders so that they at least meet the minimum safeguards suggested by most experts antiviral stockpiles to protect 100 million Americans.

Schumers letter to Sec. Leavitt stressed that simply shifting the burden to states to purchase Tamiflu without full reimbursement undercuts their commitment to safeguard Americans with significant stockpiles. HHS has the funding to purchase enough antivirals, but under its new plan, it leaves the states with the expensive and difficult task of buying Tamiflu on its own, without full or quick reimbursement.

And even worse, HHS is rebuffing questions from states that are trying to access the paltry 25% subsidy that HHS did promise. States have received more assistance from the manufacturer and a nonprofit organization, the Association of State and Territorial Health Officials, than they have from HHS.

In recent weeks, bird flu has spread to Turkey which now has 21 reported cases. Most of the cases have been in children. All but two of the 21 confirmed human cases, it said, have involved children aged four to 18.

The bird flu (knows as H5N1) has killed tens and maybe hundreds of millions of animals since it appeared in Asia in 1997 and has infected 120 people, killing half. The strain has been identified as a type A influenza virus which is both genetically versatile and able to elude a variety of defenses making it extraordinarily dangerous. This specific type of virus constantly changes as it replicates. Additionally H5N1 has never been a strain of flu before, so nobody has any form of immunity to this type of flu.

Even birds that survive the infection excrete the virus for at least 10 days, orally and in feces, thereby facilitating further spread at live poultry markets and by migratory birds. The spread of infection in birds increases the opportunities for direct infection of humans. If more humans become infected over time, the likelihood also increases that humans, if infected with both human and avian influenza strains, could serve as the mixing vessel for the emergence of a new strain with sufficient human genes to be easily transmitted from person to person. Such an event would mark the start of an influenza pandemic.

In October, Schumer provided the names of four companies to Mr. George Abercrombie, the CEO of Roche in the United States. Roche has reached agreements with two of those companies along with 13 other entities around the world. Roche agreed in October to sublicense the production of Tamiflu to any of these companies that can produce it in quantities large enough to help meet the anticipated demand in case of a flu outbreak, and the determination as to who gets licensed will be made in cooperation with the U.S. Government and other governments around the world.

Schumers letter to Secretary Leavitt is below:

January 25, 2006

The Honorable Michael Leavitt, Secretary U.S. Department of Health and Human Services 200 Independence Avenue, SW Washington, DC 20201

Dear Secretary Leavitt:

I am writing today to urge you to immediately provide clear guidance and assistance to states that wish to stockpile the antiviral Tamiflu in preparation for a potential avian flu pandemic. I am concerned that states seem to have received far more guidance from the manufacturer of Tamiflu and from a nonprofit association regarding this Department of Health and Human Services (HHS) initiative than from the Department itself.

In the National Strategy for Pandemic Influenza, HHS revealed an initiative to subsidize states for 25% of the cost of developing antiviral stockpiles. At that time, two impediments remained to enacting this initiative: ensuring that the Roche Pharmaceuticals the sole manufacturer of the only antiviral currently known to be effective against avian flu could produce an adequate supply, and providing appropriations to HHS for the subsidy.

Both obstacles have since been removed. I have worked with Roche over the past several months to assist in forging partnerships with outside companies to fill gaps in its supply chain, and Congress appropriated $2.75 billion in the Fiscal Year 2006 Department of Defense Appropriations that the Secretary may use for avian flu vaccines, antivirals, and other necessary medical supplies. I wrote to you on December 23, asking you to immediately allocate $1.8 billion of that money for a federal antiviral stockpile, but have not heard back from you.

Although I believe that an antiviral stockpile is a federal responsibility that should not be passed on to the states, we should ensure at the very least that states have the ability to access the 25% subsidy proposed in the National Strategy. However, I understand that New York, along with several other states, has been unable to access this subsidy or to receive any information from HHS as to how or when it may do so.

Disturbingly, states have received much more information from Roche Pharmaceuticals and from the Association of State and Territorial Health Officials (ASTHO), than they have from HHS. Roche proactively contacted each State Department of Health and has reportedly been very responsive to them, and ASTHO has made itself available to answer states questions as well. Where is HHS in this process?

In fact, of the eleven State Health Department officials who have been in contact with my office, five states are purchasing Tamiflu with funds diverted from other programs because they have not been able to access the HHS subsidy. Although ten of the eleven states had contacted Roche to ask for help, only four had spoken to HHS, and two of those four reported that HHS was unhelpful or nonresponsive. And worst of all, four of the eleven states did not even know that a federal subsidy existed.

I urge you to immediately contact all fifty State Health Departments to inform them of the subsidy and assist them in accessing it. I further urge you to use $1.8 billion of the $3.2 billion appropriated to HHS by the United States Congress for antiviral stockpiling, rather than passing the costs of this expensive and vital public health project onto the states. Thank you for your consideration.


Charles Schumer U.S. Senator