- The Washington Times - Tuesday, October 11, 2005

Stung by criticism over the unpreparedness of government at all levels to address hurricane Katrina, President Bush has been taking steps to make sure another disaster doesn’t embarrass his administration.

When Hurricane Rita formed in the Gulf, the White House was noticeably more active prior to its landfall. And at a recent press conference Mr. Bush addressed in extensive detail his thoughts about the threat of an avian flu pandemic.

“If we had an outbreak somewhere in the United States,” Mr. Bush said, “do we not then quarantine that part of the country, and how do you then enforce a quarantine? … And who best to be able to affect a quarantine? One option is the use of a military that’s able to plan and move.”

So the president has given some thought to what could be a serious problem — the virus, H5N1, has already killed up to 100 people in Asia. Estimates vary, but a global outbreak could kill as many as 150 million. Papers published this week in the journals Nature and Science from researchers at the Armed Forces Institute of Pathology, the Centers for Disease Control and Prevention and Mount Sinai School of Medicine suggest the flu could be more catastrophic than previously thought.

While quarantines need to be considered, they are difficult to execute effectively in large countries like the United States with a diverse and very mobile population.

A better idea is to take steps to ensure a quarantine isn’t necessary. One idea on which health and government experts now seem to agree is the need to stockpile the anti-viral treatment Tamiflu. Jeffrey Levi of the private group Trust for America’s Health told Associated Press: “It appears that this is the only effective intervention we have once someone has been infected.” Doctors in Asia are using it to combat bird flu.

There’s one big problem — there’s not much Tamiflu to go around these days. It takes a long time to manufacture, and as governments and health agencies seek to procure the drug, they find they have to wait.

Mr. Bush hinted at this in his press conference: “One of the issues is how do we encourage the manufacturing capacity of the country… to be prepared to deal with the outbreak of a pandemic. In other words, can we surge enough production to be able to help deal with the issue?” The answer for now is “no.”

The drug was invented by Gilead Sciences of California, and it licensed manufacturing and distribution rights to Roche, the Swiss drug giant. But even though Tamiflu has been known as an effective treatment against H5N1 for several years, Roche presently cannot fill orders quickly.

According to a report in Business Week, Secretary of Health and Human Services Mike Leavitt wants a stockpile capable of treating 20 million Americans. The U.S. can now treat just over 2 million people. But a U.S. order for another 3 million treatments will be filled by Roche next year. Sen. Bill Frist, Tennessee Republican, has taken a keen interest in the issue, and has called the supply for Americans ” totally inadequate.”

“Right now, our national stockpiles of anti-viral drugs sit at dangerously low levels — about 2 percent of what we would need in a serious outbreak,” Mr. Frist wrote recently in The Washington Times.

Not only the United States is waiting. “It will take Roche two years to complete the United Kingdom’s stockpile order to treat 14.6 million of its citizens,” Business Week reports. The writer and blogger Randall Parker has created an invaluable overview of several nations’ stockpiling efforts. He illustrates the seriousness by noting the World Health Organization — which will be responsible for coordinating the counterattack on a flu pandemic — won’t even have a few million doses until the middle of next year. Today it only has 80,000.

Supply is so tight, ABC News reports Roche has had to institute a “first-come, first-serve” waiting list. Unfortunately, “the United States is nowhere near the top of that list.”

The situation is bad enough that Gilead, according to Business Week, is suing to force Roche to relinquish manufacturing rights to the drug in hopes it will be able to massively ramp up production. So far, Roche has refused.

So here’s one area where Mr. Bush could take some proactive steps. The San Francisco Chronicle reports Roche plans to build a U.S. plant, but it would not produce drugs until the end of next year. Mr. Bush could order the Food and Drug Administration to fast-track approval of other, already established U.S. plants for manufacturing the ingredients of Tamiflu. The FDA has taken similar steps in response to infectious disease outbreaks, such as its efforts to fast-track available treatments for HIV/AIDS.

And President Bush could encourage Roche to initiate a technology transfer to U.S. manufacturers to ramp up development. This would respect the property and contract rights of Roche while getting more product to the clinics, hospitals and programs that need it.

George Mason University economist Tyler Cowen, who established an avian flu Web site to track the disease, also suggests stockpiling “high-quality masks and antibiotics for secondary infections (often more dangerous than the flu itself), and more importantly have a good plan for distribution and dealing with extraordinary excess demand and possibly panic.”

Lastly, Tamiflu is an important part in a first-line defense against a flu pandemic — Mr. Frist pointed out in an outbreak, “Tamiflu is what people would go after. It’s what you’re going to ask for, I’m going to ask for, immediately.” But it is no cure-all. Work needs to proceed on vaccines, as well as procurement of other possible treatments, like an injectable form of the drug Relenza, made by GlaxoSmithKline, especially as there may be cases of resistance to Tamiflu if it is used widely.

President Bush shouldn’t focus on a quarantine just yet. He should take steps to ensure a quarantine isn’t necessary. If he has learned anything from Katrina, he can demonstrate it by taking steps to make sure that while the U.S. is presently “nowhere near the top of the list” for the treatments needed to fight an outbreak, that doesn’t last long.

Nick Schulz is Editor of TechCentralStation.com

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