Washington Editor

Editor's Note: This is part two of a two-part series on avian bird flu. Part one ran in Monday's edition.

WASHINGTON - Concurrent with the federal government's heightened attention to avian flu in recent weeks, health officials from around the world recently convened here to discuss their preparations, an international gathering that underscored the global scope of the issue.

H5N1 has been around since 1997, and Tara O'Toole, CEO and director of the Center for BioSecurity, warned that the virus "cannot be eradicated from the planet."

In Asia, where more than 100 people have been infected, mortality has been about 50 percent, a death rate that O'Toole called "unprecedented."

Just last week, European authorities held an emergency meeting in Brussels after confirmation of H5N1's spread to birds in Turkey. Many suspect it also has moved further east, to Romania, where bird samples are being tested for H5N1 infection.

That has prompted the culling of poultry - a common tactic wherever it has appeared - as well as calls for bird vaccinations.

Fears have surfaced that migrating birds could have spread it to Bulgaria and Greece, as well, and as the list of countries with potential bird flu infections seems to grow daily, Colombian officials now fear H5N1's presence in that South American country.

Some European countries already have ordered enough Tamiflu for about a quarter of their populations. U.S. officials have said that they would look to boost its stockpile to 20 million doses, though critics point out that it would take years for F. Hoffmann-La Roche Ltd. to fill such an order, as so many other countries have put in earlier requests, in addition to on-demand production difficulties associated with the product.

An alternative antiviral source could come from GlaxoSmithKline plc, the London firm that plans to increase production of its competing product, Relenza (zanamivir), over the next few years. The drug was developed by Biota Holdings Ltd., of Melbourne, Australia. But there needs to be more help.

Could Biotech Provide A Solution?

Among smaller companies working in the area is BioCryst Pharmaceuticals Inc., of Birmingham, Ala. Its portfolio includes the antiviral peramivir, which in the past exhibited potency in reducing bloodstream viral load but was shelved because it showed poor oral bioavailability. But the neuraminidase inhibitor, which belongs to the same drug class as Tamiflu, could find new life as an injectable product.

"In the spring of this year, the NIH came to us and said that avian flu could be bad news," and the organization thought BioCryst's drug had "great potential" to be a therapeutic against it, said John Nugent, the company's vice president of corporate communications. As a result, the NIH will conduct a Phase I study in healthy volunteers beginning in January, and in May, the agency plans to begin a Phase II trial in Southeast Asians infected with any type of flu.

Nugent noted that although peramivir would be delivered as a shot, it would need only a single administration, compared to Tamiflu's twice-daily dosing schedule over five days. And further, peramivir could be produced more rapidly - Cilag, a Swiss unit of Johnson & Johnson, is under contract to manufacture the drug and has the capability to produce up to 120 million doses per year. BioCryst's production relationship stems from a previous partnership with J&J, of New Brunswick, N.J.

"There's a very clear route to manufacturing of the drug," Nugent said.

He added that peramivir's shelf life is thought to be indefinite, meaning that any potential government stockpile needs could be filled within a couple of years. From a business standpoint, a stockpile might not earn BioCryst much money, but the further development isn't costing the company any resources, and it envisions that the product eventually could find a niche market among patients hospitalized for any type of flu.

"We don't anticipate is being a big year-after-year money generator," Nugent said, "but if it's got the potential to help people and potentially save lives, then the company is very excited about pushing it forward."

In terms of vaccine research, ID Biomedical Corp. in Vancouver, British Columbia, has begun developing a vaccine against H5N1, as have researchers at St. Jude Children's Research Hospital in Memphis, Tenn. Overseas, Sinovac Biotech Ltd. in Beijing and PowderMed Ltd. in Oxford, UK, have H5N1 vaccine programs.

Novavax Inc. in Malvern, Pa., has generated early success with an H9N2 vaccine, and that has led to a partnership with Somerset, N.J.-based Wave Biotech LLC to make commercial-scale supplies.

Not All Sold On Industry As An Answer

Some have cautioned against an over-reliance on industry participation. The Federation of American Scientists' Michael Stebbins stressed that because there is little money to be made on vaccines, antivirals and antibiotics, there should be "an alternative to trying to bribe companies into doing something that they don't want to do." Opposed to incentive plans to lure the industry, such as liability protection and sales guarantees, he said, "We should strop trying to force a square peg into a round hole.

"These companies are there to make profits for investors, and that's a good thing," Stebbins added. "But at a certain point, we have to take stock and allow academic and government researchers, including the NIH, to make drugs."

He cited precedents, such as the Department of Defense's vaccination efforts for its troops. Although Stebbins is critical of "a wider national policy that has been failing on public health," he warned against creating a public panic.

President Bush's comments about military quarantines, and the plans for airport quarantines released by the Centers for Disease Control and Prevention certainly could cause widespread fear.

"This isn't about panic," echoed Shelley Hearne, the executive director of the Trust for America's Health, "it's about preparedness."