Barack Obama

After Delay, U.S. Faces Line for Flu Drug

Friday, October 7, 2005

By GARDINER HARRIS
New York TImes

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.

As the months passed, however, other countries placed orders that largely exhausted Roche's production capacity this year and next.

Democrats on Capitol Hill are complaining that the delay has put Americans in jeopardy. "The administration has just drug its feet through this whole process," said Senator Tom Harkin, Democrat of Iowa, who has pressed for legislation to buy more courses of Tamiflu. A course includes enough pills for a full treatment.

Senator Barack Obama, Democrat of Illinois, said in an interview that Michael O. Leavitt, the secretary of health and human services, told senators in a closed-door briefing last week that the administration would soon place an order to raise the government's Tamiflu stockpile to 81 million courses - up from 12 million to 13 million courses expected by the end of 2006. Mr. Obama has long been urging the government to buy more Tamiflu.

"Secretary Leavitt admitted that they are currently in negotiations with Roche to try to rapidly build up those stockpiles," Mr. Obama said. "But we're behind countries like Great Britain, France and Japan, and it's probably going to cost us a lot more money than it would have to catch up."

In an interview on Tuesday, Mr. Leavitt said that the government would buy more Tamiflu although he did not specify how much.

"But it's not a surrogate for preparation," he said. "It's like saying that if we could get everyone in America to wear seat belts, we would solve auto accidents. It's part of a comprehensive solution."

Christina Pearson, a spokeswoman for Mr. Leavitt, said she could not confirm whether the Bush administration had a new goal of buying the 81 million courses.

Mr. Leavitt said the Bush administration planned to prepare for a possible influenza pandemic by strengthening both international and domestic disease surveillance programs, buying drugs like Tamiflu and investing in research to develop alternative methods of making flu vaccines.

Preparing the vaccines usually takes nine months and involves the eggs of thousands of chickens. Because chickens themselves could be wiped out in a pandemic, the present system of manufacturing vaccines is highly vulnerable.

Introduced in 1999, Tamiflu for years had disappointing sales and received little attention. But just as Bayer's antibiotic Cipro became wildly popular in the wake of the 2001 anthrax attacks, Tamiflu has become the drug of choice for those worried about pandemic flu because it is one of the only medicines proven to reduce the duration and severity of the potentially deadly disease if taken within 48 hours of infection.

Dr. Irwin Redlener, director of the National Center for Disaster Preparedness at Columbia University, is among those who have been insisting for months that the government buy more Tamiflu. But he said the Bush administration largely ignored his and others' warnings.

"And now that they're finally worked up about it, the store is closed," Dr. Redlener said, referring to Roche's supply problems. "The U.S. is now in line behind much of the rest of the world."

Terence Hurley, a Roche spokesman, said that 40 countries had ordered Tamiflu to fill medical stockpiles in case of a pandemic. Many countries in Europe - including France, Britain, Finland, Norway and Switzerland - have ordered enough to treat 20 percent to 40 percent of their populations. The American stockpile would treat less than 2 percent of the population.

Mr. Hurley said that Roche would be able to deliver all the courses that the United States government has currently ordered, including at least two million courses ordered this year.

Asked how soon the company could produce 68 million more courses if the United States placed such an order, Mr. Hurley refused to say. "We're just going to have to see what their demands are," Mr. Hurley said. The suggested 81 million courses would cover more than a quarter of the population.

The government and industry officials, however, said that Roche had committed to delivering seven million courses to the United States next year and would not be able to deliver substantially more until 2007.

Since 1997, avian flu strains have killed millions of birds in nearly a dozen countries. But so far, nearly all of the people infected - more than 100 so far, including some 60 who died - got the sickness directly from birds. Until the virus passes easily among humans, it is unlikely to cause a pandemic that could kill millions.

An outbreak, therefore, may still be years away or may never occur. But news this week that the 1918 flu virus, which killed at least 50 million worldwide, was also a form of avian flu raised concerns further.

On Thursday, Senator Hillary Rodham Clinton, Democrat of New York, and Senator Pat Roberts, Republican of Kansas, introduced a bill that would bolster defenses against the flu.