"A General Sense of Urgency"

| Fri Oct. 7, 2005 6:56 PM EDT

As concern about a flu pandemic sweeps official Washington, Congress and the Bush administration are considering spending billions to buy the influenza drug Tamiflu. But after months of delay, the United States will now have to wait in line to get the pills.

Had the administration placed a large order just a few months ago, Roche, Tamiflu's maker, could have delivered much of the supply by next year, according to sources close to the negotiations in both government and industry.

New York Times
After Delay, U.S. Faces Line for Drug
October 7, 2005

Certainly the leading influenza researchers, from the first H5N1 outbreak in 1997, have been doing their utmost to alert medical colleagues worldwide to the urgent threat of avian flu, as well as outlining the immediate steps the Bush Administration and other governments needed to take. As befitted his position as "pope" of influenza researchers, Robert Webster of Saint Jude Hospital in Memphis tirelessly preached the same sermon…

Webster stressed the particular urgency of increasing the production and stockpiling of the NA inhibitor Tamiflu. Because this strategic antiviral was "in woefully short supply"--it is made by Roche at a single factory in Switzerland--Webster and his colleagues underlined the need for resolute government action.

The Nation
Avian Flu: A State of Unreadiness
June 29, 2005

According to his official biography, Stewart Simonson is the Health and Human Services Department's point man "on matters related to bioterrorism and other public health emergencies." Hopefully, he has taken crash courses on smallpox and avian flu, because, prior to joining HHS in 2001, Simonson's background was not in public health, but ... public transit. He'd previously been a top official at the delay-plagued, money-hemorrhaging passenger rail company Amtrak. Before that, he was an adviser to Wisconsin Governor Tommy Thompson, specializing in crime and prison policy. When Thompson became HHS secretary in 2001, he hired Simonson as a legal adviser and promoted him to his current post shortly before leaving the Department last year. Simonson's biography boasts that he "supervised policy development for Project BioShield," a program designed to speed the manufacture of crucial vaccines and antidotes.

The New Republic
Welcome to the Hackocracy
October 7, 2005

A year after President Bush signed Project BioShield into law, only one big contract has been awarded -- $878 million for a novel anthrax vaccine -- and none of that money has been disbursed. A few smaller contracts have been handed out, but others for promising vaccines and drugs have stalled in the federal health bureaucracy.

Wall Street Journal
U.S. struggles for drugs to counter biological threats
July 11, 2005

To many infectious-disease experts, Project Bioshield was Bush and Thompson's version of Alice's Adventures in Wonderland: with priorities established in inverse relation to actual probabilities of attack or outbreak. "It's too bad that Saddam Hussein's not behind influenza," complained Dr. Paul Offit, a dissident member of the government's advisory panel on vaccination. "We'd be doing a better job."

Indeed, HHS's zeal to combat hypothetical bioterrorism contrasts with its incredible negligence in exercising oversight of the nation's "fragile" influenza vaccine supply. As the GAO had warned Clinton's HHS Secretary Donna Shalala, vaccine availability in a pandemic would depend on the stability and surge capacity of existing production lines. But as shocked Americans discovered in the winter of 2003-04 and again in early fall 2004, the entire vaccine manufacturing system had decayed almost to the point of collapse. While Bush and Thompson were trying to bribe the pharmaceutical industry to join Project Bioshield, the same industry was abdicating its elementary responsibility to maintain a lifeline of new vaccines and antibiotics.

The Nation
Avian Flu: A State of Unreadiness
June 29, 2005

"A general sense of urgency informs all of our homeland security work," said Stewart Simonson, an assistant secretary at the Department of Health and Human Services, or HHS, which jointly administers Bioshield with the Homeland Security Department.

Copley News Service
Congress urged to streamline Bioshield Program
July 12, 2005