Tamiflu expiring in some Asian countries: Can they afford to toss and buy more?

By: MARGIE MASON - Associated Press | Friday, February 2, 2007 7:57 PM PST ∞

HANOI, Vietnam -- After three years of fighting bird flu, some poor Asian nations must face a painful health dilemma: whether to spend millions of dollars to replace expiring drug stockpiles for a pandemic that may never come.

Vietnam, Cambodia and the Philippines will be the first on the front lines to see their stocks of Tamiflu medicine expire by year's end. Countries worldwide have been racing to stockpile the antiviral, which experts hope might help fight a pandemic flu, but no one knows for sure whether it will actually work.

Leaders must decide whether to play it safe and restock at great expense or gamble that the H5N1 bird flu virus will never become a mass killer and spend the money on diseases like AIDS or tuberculosis instead. This choice will eventually confront every nation that stockpiled antivirals amid fears that a pandemic was looming.

"If the threat lingers for many years, what happens then?" asked Megge Miller, an epidemiologist at the World Health Organization in Cambodia. "It's just (like) throwing money into a black hole."

Since bird flu began ravaging Asian poultry in late 2003, 80 governments worldwide have ordered enough Tamiflu to treat around 200 million people, at a cost per person of $9 for the poorest countries to more than $19 for the richest, said Martina Rupp, spokeswoman for the drug's manufacturer, Swiss-based Roche Holding AG.

Each person must take 10 pills to complete a treatment course. The cheapest form of Tamiflu is sold in bulk powdered form, but it poses logistical challenges because it must be measured and mixed with water for drinking.

If stored properly, Tamiflu capsules have a shelf life of five years before the outer coating starts to break down. Roche is researching whether the drug can last longer, and Rupp said the company will help countries test expired stocks for effectiveness. But some Asian health officials say they plan to simply toss their pills when the expiration date arrives.

"If they expire, we have no choice but to destroy them," said Richard Panjaitan, director general of Pharmacy and Health Equipment at Indonesia's Health Department. He said the law requires that all expired drugs be thrown out. The country's stockpile for 1.6 million people will remain good through 2009.

Since Indonesia -- the nation hardest hit by bird flu with 63 deaths -- also is one of the few countries where Tamiflu is not patent protected, it can produce its own cheaper version of the drug for domestic use.

Others do not want to see their supplies go to waste. Vietnam plans to start using its Tamiflu to treat patients with seasonal flu, hoping to use at least some of the medicine that's stored for 60,000 people before it expires in December, said Cao Minh Quang, who oversees the reserve. All of Hanoi's current Tamiflu was donated by Taiwan in 2005, and it's unclear whether Vietnam will restock, Cao said.

Additionally, the WHO in Hanoi has enough Tamiflu for 4,500 people that could be deployed in an emergency, said country representative Hans Troedsson.

Using Tamiflu for seasonal flu isn't a bad idea as long as it is taken properly, said Dr. Fred Hayden, a WHO virus expert in Geneva.

"I think, clearly, the benefits that are accrued by use of the drug for seasonal influenza outweigh some of the theoretical risks that are there with regard to resistance emerging," Hayden said.

The H5N1 virus resurfaced recently in several countries, reviving fears it may mutate into a form that passes easily among people, potentially igniting a pandemic. It has killed at least 164 people since 2003 but remains difficult for humans to catch. Most cases have been traced to close contact with infected birds.

The public and some government leaders have started showing signs of bird flu fatigue after being placed on long-term alert for a potential crisis that hasn't developed, said Peter Cordingley, WHO spokesman for the Western Pacific region.

"They're stockpiling these pills against a rainy day and the sun continues to shine, so it's a real difficult decision for them," he said. "But our recommendation is that they should continue to replenish."

John Blatherwick, chief medical officer of Vancouver Coastal Health Authority, disagrees with stockpiling millions of pills that can help fight the current virus but may not work if it evolves into a new pandemic strain. He has openly criticized Canada's decision to spend $118 million to cover about 5.5 million people with Tamiflu and another antiviral, Relenza, that also has a five-year shelf life.

"I think that we should be dealing with diseases that are real, that are here today," Blatherwick said. "The way that Canada has been stockpiling Tamiflu is a waste of money. The capsules will disintegrate in five years and we'll have mush."

In the United States, the expiration date isn't an issue because the federal contract has a built-in shelf-life rotation. The government stockpile holds enough medicine for about 22 million people, with enough for 9 million more awaiting delivery.

Skeptics point to a swine flu scare in 1976 that began when soldiers fell ill at Fort Dix, N.J. U.S. health officials believed a pandemic was brewing and a mass immunization campaign was started. The flu itself killed only one person, but dozens of others died from the vaccine.

Health officials fear a pandemic on the same scale as the 1918 Spanish flu pandemic that killed up to 50 million people. Even if a repeat never occurs, they say their efforts will have strengthened health systems to handle other emerging diseases.

"The possibility is there. We have to be prepared," said Ramlee Rahmat, Malaysia's deputy director-general of public health. "It's better to be safe than sorry."

He said Malaysia has stockpiled enough Tamiflu and Relenza for 630,000 people, and it will expire by 2010. The government plans to continue adding more to the reserve each year.

In addition to national arsenals, Roche donated a global stockpile of Tamiflu for 3 million people that's available to deploy if a pandemic erupts. Enough pills for another 2 million people also were given to a regional stockpile; all will expire in 2011. Many WHO country offices also have individual supplies.

In the Philippines, the Tamiflu stockpile is stored in an air-conditioned room in a warehouse. Boxes are piled nearly to the ceiling, many with an expiration date of November 2007 stamped on the side.

By December, enough medicine for about 25,000 people will expire in the Philippines, leaving treatment for just over 13,000 people in the national stockpile. Part of the supply will likely be replaced by a local company, since Tamiflu is not patent-protected there, said Enrique Tayag, director of the Department of Health's National Epidemiology Center.

-- Associated Press Writers Tran Van Minh in Hanoi; Ker Munthit in Phnom Penh, Cambodia; Irwan Firdaus in Jakarta, Indonesia; Eileen Ng in Kuala Lumpur, Malaysia; Teresa Cerojano in Manila, Philippines, and Beth Duff-Brown in Toronto contributed to this report.

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