Lawmakers want answers on unspent flu vaccine funds

Key members of Congress -- Democrats and Republicans -- want to know why the Health and Human Services Department is sitting on $2.5 billion appropriated in 2005 and 2006 to protect Americans against bird flu and other pandemic influenzas.

Rep. Kay Granger, R-Texas, a member of the House Republican leadership, is hoping to call HHS Secretary Mike Leavitt on the carpet at a hearing to explain the holdup. Granger and six other GOP leaders sent a letter to Leavitt in June asking why the money hasn't been spent.

"We are concerned about the slow progress in completing key elements of the department's preparedness plans. One of the most notable of those elements is the planned stockpiling of anti-virals," they wrote. "The planned anti-viral stockpile remains incomplete despite the fact that ample resources are available now to put that part of the plan firmly in place."

Signers included House Minority Leader John Boehner of Ohio, Minority Whip Roy Blunt of Missouri, and Republican Conference Chairman Adam Putnam of Florida.

There is no bird flu vaccine yet, so the federal government asked Congress for money to stockpile anti-viral medications -- the kind that people take when they get seasonal flu -- as part of its National Strategy for Pandemic Influenza. A vaccine would take at least six months to develop after a pandemic strikes, and scientists say that the best treatment in the interim would be anti-viral drugs, which reduce the severity of flu symptoms.

The reserve is designed to have enough medication by 2008 to give 25 percent of the U.S. population five days of treatment. That translates to 81 million courses of treatment. The federal government was supposed to purchase 50 million courses, and HHS encouraged states (by offering a subsidy) to buy the remaining 31 million. So far, HHS has spent $3.6 billion of the $6.1 billion appropriated since 2005.

But to date, the reserve holds enough anti-virals to cover only 15 percent of the population, according to Thad Cochran of Mississippi, the Senate Appropriations Committee's ranking Republican.

HHS spokeswoman Holly Babin said that Congress has approved only two-thirds of the money that President Bush requested in 2005 for anti-viral medications and that HHS is waiting for an additional $248 million that it requested in this year's appropriations process.

Granger says that Leavitt never responded to her letter, so she called him last week. "He said no, that he didn't intend to use the unobligated funds. This is very disturbing. He said there was a timeline, and that there are other needs that he must put ahead of that. I wasn't satisfied with his answer."

Granger said that Leavitt seemed to be hoping that a bird flu vaccine will be developed, although it would be hard to make an effective one without knowing which strain of influenza virus has mutated to start a pandemic.

"Public health experts estimate that a pandemic of even relatively low severity could potentially cause 90,000 deaths if appropriate precautionary measures are not put in place," Cochran said in a September 10 letter to Leavitt. "In lieu of a vaccine that has yet to be completely developed, and knowing that even the experimental vaccine would not be available in sufficient quantities at the outset of an influenza pandemic, I urge you to designate any unobligated funds under [the National Strategy for Pandemic Influenza] toward the completion of purchases of anti-virals for the stockpile."

House Majority Leader Steny Hoyer, D-Md., and two other House Democrats sent a similar letter in August. Hoyer did not get a response, according to an aide in his office. "Mr. Hoyer is still concerned that we're not fully prepared to face a flu pandemic, and it's concerning that Secretary Leavitt has not responded to several requests," said Hoyer's spokeswoman, Katie Grant.

It's not that the drugs don't exist. Indeed, the Swiss-based pharmaceutical manufacturer Roche has geared up its production of anti-virals and is awaiting authorization to fill a U.S. order. Roche manufactures Tamiflu, which makes up the bulk of HHS's stockpile because it is widely considered the most effective medication against bird flu. GlaxoSmithKline makes another anti-viral, Relenza, but it has been the second choice partly because it requires an inhaler.

At the government's request, Roche set up a self-contained manufacturing operation for Tamiflu in the United States, so that the company would not be dependent on any other country to supply Americans in a pandemic. (The concern is that governments would require drugmakers within their borders to treat their citizens first.) The company increased its production capacity from 80 million treatment courses a year to 400 million and switched from blister packs to bottles, also in response to U.S. requests.

Already, however, the company has had to "tailor down to meet demand, which is much lower than what we anticipated," said Mike McGuire, Roche's vice president of anti-infectives. If orders don't pick up soon, McGuire predicted that smaller manufacturers that have subcontracted with Roche to help it produce the 400 million treatment courses a year will turn to other drug projects.

Even if HHS signed a contract with Roche today to fulfill the Tamiflu orders, it would take two to three months for the company to deliver, McGuire said. Roche has some Tamiflu in production, but it won't complete the process until it has a contract, to ensure the longest possible shelf life for the product, according to McGuire.

"There's a six-step process to manufacturing Tamiflu," he said. "We have made various amounts of the product at each step. We never really produce in anticipation of an order. If we produced 10 million more, and the government doesn't buy it until March, we've lost some dating. We want to give them the best dating." Tamiflu can be stored for as long as 60 months, the manufacturer says.

In the meantime, if other governments or corporations signed contracts with Roche to buy Tamiflu, Roche would tap that "almost ready" supply. If subcontractors have moved to other projects, it could take up to eight months for the company to resume deliveries to HHS, McGuire said.

"If we were to get orders from the government, we would do everything we could to manufacture it as quickly as possible," McGuire said. "But in all of our discussions, all the way to our CEO, our mantra has been, once a pandemic starts, it will be too late, and that's why we need to be prepared now, and part of it is stockpiling."

States also have not met their goal of purchasing anti-virals. Under the National Strategy for Pandemic Influenza, the federal government has called on states to hold a total of 31 million treatment courses, as part of the 81 million overall. As an incentive, the U.S. is covering 25 percent of a state's bill. But states are not required to comply.

States have purchased 12.7 million treatment courses of Tamiflu, according to McGuire. Altogether, he said, 38 states have ordered Tamiflu from Roche, and 15 of them ordered their full allotment.

Part of the problem is logistical. Some state legislatures meet only during certain months, and that has slowed funding decisions. In addition, some state leaders have been hesitant to buy the medications, concluding that their money might be better spent on other protective measures.