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Experts question necessity of Tamiflu to ward off virus
Governments have begun ordering stockpiles of an antiviral drug as a hedge against a possible pandemic of bird flu in humans. Should the rest of us do the same?
By DEBORAH FRANKLIN
The New York Times
April 5 -- As a hedge against a possible worldwide pandemic of bird flu in humans, the governments of at least 17 countries have in recent weeks begun ordering stockpiles of Tamiflu, the potent antiviral drug with a sunny Sandra Dee of a name.
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A man takes his goose chicks for a walk Tuesday March 16, 2004, in Taiping, about 1800 kilometers (about 1100 miles) south of Beijing, China. China declared victory Tuesday in its fight against bird flu, saying it had "stamped out" all of its known cases. But the government warned against relaxing vigilance, saying coming warm weather could bring new cases. (AP Photo/Eugene Hoshiko)But should the rest of us do the same? Until there's a vaccine against the virus (and clinical tests of a prototype have only just begun), Tamiflu will probably be our best defense. Why not, just in case, pester our doctors into prescribing a five-day packet of pills?
"Resist that urge," said Dr. Ben Schwartz, a pediatrician and infectious disease specialist with the National Vaccine Program Office in Washington. Although he rates Tamiflu as a powerful tool in the global medical arsenal, Dr. Schwartz says he has not squirreled away an emergency store for himself or his loved ones.
Just two years ago, the Swiss-based pharmaceutical giant Roche was having trouble getting doctors to prescribe Tamiflu even for patients who were sick. First approved for sale in the United States in 1999, the drug, also known as oseltamivir phosphate, cripples influenza's ability to spread from cell to cell by blocking a crucial enzyme, neuraminidase.
According to the drug's label, which took only premarket research into account, Tamiflu can hasten recovery from flu by a day or two. To be effective, it must be started within 48 hours of the first symptoms - abrupt fever, cough, congestion and racking muscle aches in adults, or simply a sudden fever in children.
"Most people don't get to the doctor that fast," said Dr. Janice Louie, an infectious disease specialist who helps track flu for the California State Department of Health Services. "Early on, the benefit didn't seem that substantial relative to the cost."
More recent research has shown that Tamiflu not only shortens a flu bout if taken promptly, but also markedly cuts serious complications including pneumonia and secondary infections that require antibiotics or hospitalization.
Still, what has prompted the global stockpiling isn't concern about garden variety flu but rather worry about the particularly quick and virulent leap from birds to people that a Type A avian strain known as H5N1 has made in Southeast Asia. Among the 74 people in the last year confirmed to have been infected with H5N1, many were young and previously healthy, and 49 died from their infection.
Nearly all are thought to have caught the virus through contact with infected poultry, not people. No one can say if or when H5N1 will develop the ability to spread easily and efficiently from person to person - the last step required to start a pandemic - or whether the virus will retain its lethal virulence if that happens.
Still, the signs from Asia are ominous enough that nations are scrambling to come up with a vaccine and are placing huge orders for what's widely expected to be the best of imperfect treatments - Tamiflu - with Roche, the world's sole supplier. Another drug from the same chemical family, Relenza (or zanamivir) from GlaxoSmithKline, is not being stockpiled to the same degree because its use is more limited, excluding children under 7 and people with asthma or other chronic lung disease.
So far, the United States has just 2.3 million treatment courses of Tamiflu on hand; discussions are under way about how much more might be needed and who would get them first. According to a Roche spokesman, Terence Hurley, among the other countries that have placed firm orders, Britain will buy 14.6 million courses of the drug; France wants 13 million; and Canada, 5.4 million. The orders are to be filled over the next several years.
Roche, too, has scrambled to increase production to meet the increased demand, doubling its production capacity for Tamiflu from 2003 to 2004, with another doubling expected by the end of 2005. The plan, Mr. Hurley said, is to bring additional manufacturing to the United States in the fall, with the first pills from those plants reaching the market 10 or 12 months later.
Of course, a pandemic could strike sooner. Though Mr. Hurley insisted that Roche had "more than enough" Tamiflu to meet demand, Dr. Dominick Iacuzio, Roche's medical director, said that panic buying would deplete inventories.
"If everyone went out to buy a personal stockpile right now, there wouldn't be enough," Dr. Iacuzio said.
Still, just reading the words "pandemic" and "stockpile" in the same sentence can be enough to kindle acquisitive angst, said Dr. Howard Markel, a medical historian at the University of Michigan. "Historically, whenever there's a crisis you'll find stockpiling, hoarding, black marketeering and generally bad behavior," he said. "It's been going on since Hippocrates."
Dr. Schwartz said he thought a hefty national stockpile made sense in ways that a personal stockpile didn't. For starters, drugs in a national cache are stored under ideal conditions and regularly checked to make sure pills close to their expiration date are still potent, he said. The same drug in the medicine cabinet of a humid bathroom could quickly lose its effectiveness.
Plus, governments typically get a price break, he said. Don't expect such a discount at your local pharmacy, where a five-day prescription for Tamiflu can run $65 to $100 or more.
If economics and altruism aren't strong enough to stop you from trying to secure a personal stash, consider the problem of drug resistance, which is exacerbated by improper use. The older and cheaper generic flu drugs, amantadine and rimantadine, no longer work against H5N1, probably because of the past widespread use of the antivirals in some parts of the Asian poultry industry.
Having a packet of pills on hand "just in case," increases the temptation to take them for a bad cold instead of the flu, Dr. Markel said, or to stop taking the drug once you start feeling better - just the sort of pill-popping that breeds resistance.
"Everybody - doctors, journalists and hamburger flippers - takes drugs inappropriately at one time or another," he said. "Self-prescription is not good for anyone."
There's already a little evidence that H5N1 is evolving to get around Tamiflu, too, though the resistant versions of the worrisome strain that have popped up seem weaker than those susceptible to the antiviral. So far.
"It would behoove us to be as careful with these drugs as we are with antibiotics," Dr. Schwartz said. "The basic point is we don't have a lot of arrows in our quiver."
Story Produced by: Bianca M. Ferrer
