Washington Editor

Editor's Note: This is part one of a two-part series on the threat of avian bird flu. Part two will run in Tuesday's issue.

WASHINGTON - Awaiting the federal government's official policy to address the pandemic potential of avian influenza, myriad voices have called for a variety of actions to be incorporated into the final draft.

Many beat the same drum, noting that improved incentives would better entice drug industry participation, though others say the government should shoulder the development and commercialization load on its own.

Still, as interested parties look for a national plan, they agree on the underlying urgency of the matter. There's been a flurry of recent attention paid to bird flu - particularly the H5N1 strain that lately has made its way from Asia to Eastern Europe and perhaps South America - and the general perception of the U.S. is one of bleak unpreparedness.

"The clock is ticking," said Gregory Poland, a Mayo Clinic staffer speaking on behalf of the Infectious Diseases Society of America at a recent briefing on Capitol Hill. "We just don't know where on the clock we are right now."

The dire message is this: H5N1, or another similarly virulent virus, soon could develop the ability to jump from human to human. Already, H5N1 has killed almost half the people who have been infected by way of bird-to-human transmission, and Poland noted that the strain is two amino acid mutations away from enabling human-to-human transmission.

"A pandemic will occur," he said, "we just don't know when."

At last week's congressional briefing, many called for the federal government to provide liability protection for vaccine makers and help guarantee the market by promising to purchase finished product. They collectively recommended public spending in excess of $5 billion to better prepare.

Already, the National Institutes of Health has tested vaccines in clinical trials against H5N1 and H9N2, another bird flu strain of concern, and a number of the industry's recognizable vaccine makers have entered development deals with the government.

Two companies have received contracts to produce H5N1 vaccines: Sanofi Pasteur in Lyon, France, has a $100 million order, while Chiron Corp. received a smaller contract. Chiron, of Emeryville, Calif., also has a government contract to test a vaccine against H9N2. More recently, MedImmune Inc., of Gaithersburg, Md., entered an agreement with the National Institute of Allergy and Infectious Diseases to produce and test versions of the company's attenuated, live intranasal influenza vaccine against different types of potential pandemic flu strains, including one based on H5N1.

Many also have clamored for increasing the federal antiviral stockpile, which is woefully lower than World Health Organization recommendations, as well as for improving surveillance systems, hospitals and other care facilities, and for focusing on adjuvant vaccines, which would require less antigen per dose.

U.S. Government Promoting Action

Following the revelation two weeks ago that the 1918 Spanish flu pandemic was borne of a bird flu strain, a discovery made upon the genetic reconstruction of the virus that killed up to 50 million people worldwide, the Bush administration began ramping up its communications on H5N1's pandemic potential. The president himself called together heads of several flu vaccine manufacturing companies to confer at the White House, weeks after he addressed the United Nations on a new international partnership to address the feared pandemic.

It's a call to action that observers of the public health sector have been awaiting. "The [Bush] administration has not taken public health very seriously," said Michael Stebbins, the director of biology policy for the Federation of American Scientists in Washington. "Whether there will be a pandemic or not, we have to take public health more seriously than we have."

The head of the Department of Health and Human Services, Mike Leavitt, has been touring Southeast Asia to promote cooperative efforts to tackle bird flu. Top officials at his agency, which has released a draft of its pandemic preparations, have said it could kill as many as 1.9 million Americans in 18 months, though Tara O'Toole, at the University of Pittsburgh's Center for BioSecurity, estimated that 40 million could die.

On Capitol Hill, the Senate recently approved $3.9 billion for bird flu preparations. Three-quarters of that amount is slated for acquiring Tamiflu (oseltamivir, from F. Hoffmann-La Roche Ltd.), the antiviral that has shown efficacy against H5N1 if administered shortly after infection. (Editor's Note: In a paper in the Oct. 20, 2005, issue of Nature, researchers suggest that the current prophylactic regimen of Tamiflu could have contributed to the emergence of partial drug resistance in a Vietnamese patient.)

At present, the federal government supply of Tamiflu is sufficient for only a few million people, though officials have reported plans to increase the stockpile to cover 20 million. The remaining $1 billion would be earmarked for infrastructure planning to shore up distribution and treatment issues. (See BioWorld Today, Oct. 6, 2005.)

Still, it remains uncertain whether the House of Representatives would pass the bird flu provision, which was attached to a military funding bill. If not, it won't be for lack of knowledge - in the past few months, House members have heard a good deal about the bird flu at a pair of hearings that included top public health officials and industry representatives. (See BioWorld Today, April 13, 2005, and May 31, 2005.)

Tuesday's issue will examine companies researching products for the bird flu and the virus' fast-growing range.