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Tuesday November 21, 2000

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Daily pill can prevent, not just treat, flu

By The Associated Press

WASHINGTON - Taking the prescription flu therapy Tamiflu not only treats influenza, but a pill a day during an outbreak can prevent the misery-inducing illness almost like a vaccine, the government announced yesterday.

Don't deliberately skip the flu shot thinking you'll just pop a few Tamiflu pills, the Food and Drug Administration stressed.

"Our message is still that vaccination is the No. 1 preventive method against influenza," said Dr. Debra Birnkrant, FDA's acting antiviral drug director.

Despite vaccination campaigns, influenza sickens 20 million Americans each year, kills 20,000 and hospitalizes thousands more. So doctors have long hoped for ways to protect more people - especially the unvaccinated and elderly patients in nursing homes, where flu takes a huge toll.

Coincidentally, the Tamiflu news comes as Americans are becoming increasingly anxious about getting this year's flu shot. Vaccine production was delayed a few months, prompting officials to urge healthy people to wait until December for a shot so that frail people most in danger from flu would get the earliest vaccine shipments. Vaccine is being shipped now, and the government insists 75 million doses - the same amount as last year - will be available.

Tamiflu, made by New Jersey-based Hoffmann-La Roche, already is used as a treatment that shortens flu patients' misery by about a day, if taken shortly after symptoms appear.

But yesterday, the FDA announced that one Tamiflu pill taken every day during a flu outbreak can help prevent people ages 13 or older who are exposed to influenza from getting sick in the first place. It works by targeting a protein important to the flu virus' ability to infect cells.

For many people, once-a-year vaccination will remain the easier and cheaper method. Many Americans, including Medicare patients, get flu shots free through insurers or employers, or for less than $20 during public vaccine campaigns.

In contrast, a 10-day supply of Tamiflu costs $49 wholesale - and patients have to swallow a pill every day of an outbreak, which in some Tamiflu studies lasted 42 days. Roche is negotiating with insurance companies about covering Tamiflu for flu prevention; Medicare doesn't pay for prescription drugs.

How well did Tamiflu work? In one study, just 1.2 percent of unvaccinated people who took it during a 42-day community flu outbreak got sick, versus 4.8 percent of people who took a dummy pill. Tamiflu also protected family members who took it within 48 hours of a child or other relative bringing the flu into their home.

In what may be Tamiflu's most important public health benefit, nursing home studies found less than half a percent of elderly residents who took Tamiflu got sick, vs. 4.4 percent who took a dummy pill.

Most of these nursing home residents had been vaccinated, yet Tamiflu offered additional protection. While the flu vaccine is about 90 percent effective over an entire flu season, many experts believe it doesn't protect the very old quite as much as it does younger people, one reason flu is so deadly in nursing homes. Roche could not say if Tamiflu provides extra protection for younger, healthier people who get vaccinated and thus are at low risk of catching influenza.

Side effects include nausea, vomiting and headache. The FDA will monitor whether the flu virus develops resistance to long-term Tamiflu use.