Washington Editor

WASHINGTON - Industry leaders urged lawmakers at a Congressional hearing last week to step up federal government efforts to prepare for a pandemic flu outbreak.

Members of the House Subcommittee on Health, part of the Committee on Energy and Commerce, listened to testimony from several drug company executives, as well as top public health officials, on the state of the nation's preparedness for what all agreed is a potential health crisis looming on the horizon. And several speakers indicated that the country is anything but ready.

"The U.S. has to make a commitment now," stressed Dominick Iacuzio, the medical director at F. Hoffmann-La Roche Ltd., in discussing federal plans to stockpile that company's antiviral drug, Tamiflu (oseltamivir), which is effective against the H5N1 avian flu strain. "Any government that does not stockpile sufficient quantities of Tamiflu in advance cannot be assured an adequate supply at the outbreak of an influenza pandemic."

His recommendation, and warning, followed testimony from a trio of public health officials that the U.S. has an existing stockpile of 2.3 million Tamiflu doses, enough for about 1 percent of the nation's population. The government has agreed to a non-binding letter of intent to purchase another 3 million doses, though such an increase would only up the nation's stockpile to cover 2 percent of the population.

That figure falls well short of a recommendation of 50 percent by the Infectious Disease Society of America. Furthermore, it also lags behind orders Roche has taken from other countries such as France, Finland, Norway, New Zealand, Switzerland and the UK to build stockpiles for 20 percent to 40 percent of their populations. The company continues to ramp up its production capabilities to meet that demand, and Iacuzio added that it could provide 25 percent coverage in the U.S. by the end of 2007 if "the order was placed today."

"The U.S. is woefully unprepared for a pandemic that might happen in the next few years," said Andrew Pavia, the chairman of a pandemic flu task force at the Infectious Disease Society of America. "The 2.3 million doses currently in the U.S. stockpile are clearly inadequate."

Among the panel of public health officials, Julie Gerberding, the director of the Centers for Disease Control and Prevention, said that until definitive evidence on antivirals' effectiveness is better proved, large bulk orders could be premature. Her thoughts were echoed by Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, who noted that while antivirals do work to shorten the flu's duration and treat the infection, they do not stop it outright.

There also was talk of resistance to Tamiflu, though Iacuzio said those findings stemmed from studies in which lower-than-recommended doses were used. "You're creating a scenario to generate resistance," he said of such studies, adding that among people affected by the avian flu outbreak to date, those treated with Tamiflu within 48 hours suffered no deaths.

Gerberding later noted that "we have made the decision to increase our stockpile," though she declined to specify numbers. Bruce Gellin, the director of the National Vaccine Program Office at the Department of Health and Human Services, also noted that the government remains in procurement talks with Roche, of Basel, Switzerland.

Fauci noted that further research on Tamiflu's effectiveness is planned at the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health, as well as evaluations of other targets for H5N1 and similar flu strains. Also under early evaluation are RNAi-based antivirals, which are being developed through a collaboration between the University of Georgia and Alnylam Pharmaceuticals Inc., of Cambridge, Mass.

Of equal importance in preparing for a pandemic flu outbreak is the development of relevant vaccines. Sanofi Pasteur, of Lyon, France, manufactures much of the flu vaccine lots for U.S. consumption and has received federal contracts to produce a small quantity of H5N1 vaccines, as well as egg and cell culture production technology. The NIH is testing vaccines in clinical trials against H5N1 and H9N2, another avian flu strain. Philip Hosbach, that company's vice president of immunization policy and government affairs, said an expansion of its vaccine manufacturing capabilities in Swiftwater, Pa., is nearly complete.

And, he added that the U.S. government must take action to encourage companies to enter the same space as part of overall preparedness plans. Among his recommendations was a call to increase regular flu immunizations, better develop vaccine distribution networks, build stockpiles of all routinely recommended pediatric vaccines, as companies likely would put such production on the backburner when trying to respond to a pandemic flu, and offer liability protection.

As the public-private sector dialogue moves forward, look for more concern to surface. In expressing worry over small U.S. stockpiles of antivirals and vaccines, Marcia Crosse, the director of health care for the U.S. Government Accountability Office, said, "It will be years before these preparations are in place."