Washington Editor

WASHINGTON - Pandemic flu preparations already are under way, said government health officials who testified Tuesday before a congressional subcommittee, even as alarm bells are resonating more and more loudly.

"The threat of a pandemic is now felt to be greater than it has in decades," said Bruce Gellin, the director of the national vaccine program at the Department of Health and Human Services. "This is in large part because of the highly pathogenic bird flu, an influenza virus classified as H5N1, which is established and endemic in many different species of birds across Asia."

Most alarmingly, researchers have established that the same strain has crossed into 74 people in the past year, killing two-thirds. And those figures "probably represent the tip of the iceberg," said Julie Gerberding, the head of the Centers for Disease Control and Prevention, who also sat before the House of Representatives' Subcommittee on Labor, Health and Human Services, Education and Related Agencies.

In an effort to head off that danger, testing of vaccines and antiviral therapies is in progress under the watch of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Its director, Anthony Fauci, told the subcommittee that initial clinical testing of an H5N1 vaccine produced by Sanofi-Pasteur is under way, and that the Swiftwater, Pa.-based company is under contract to produce 2 million doses of the product. Other clinical trials of the same vaccine will be held later this year, and simultaneous research on three attenuated H5N1 vaccine strains is being conducted, as are studies on an attenuated vaccine strain of H9N2, another avian virus that has jumped into humans.

Also, since the antiviral drug Tamiflu (oseltamivir, from F. Hoffmann-La Roche Ltd.) is effective against H5N1, the federal government has stockpiled 2.3 million units. In its budget request for the coming fiscal year, the Department of Health and Human Services requested an additional $120 million to support its pandemic preparedness activities, such as ensuring a year-round supply of chicken eggs to provide for a secure vaccine supply and shifting manufacturing to cell culture technologies.

Concurrent with those actions, Gerberding stressed the importance of international cooperation. She described research networks at the World Health Organization, highly connected laboratory networks within the U.S. and federally funded research outside U.S. borders.

"Part of preparedness," she said, "is working with the countries most at risk."

Although the gathering focused primarily on pandemic flu preparations, members of the subcommittee, part of the House Committee on Appropriations, also quizzed the public health trio on preparations for the coming flu season. Concerns were raised about a lack of domestic manufacturing.

Rep. David Obey (D-Wis.), who proposed that a government-backed program to ensure adult vaccinations should be implemented, asked whether such a system would "possibly save as much money on hospitalizations and deaths as that program [would] cost?" Rep. Nita Lowey (D-N.Y.) advocated annual government purchases of flu vaccines to the point of overstocking, even though they would have no use the next year.

An underlying concern of the subcommittee was directed at last year's flu vaccine shortage, which Gerberding addressed by saying that the myriad government health agencies are preparing for all scenarios connected with the challenges associated with annual flu vaccine manufacturing.

"We are not going to assume anything about the supply," she noted, adding that despite manufacturers' optimistic outlook to date, plans are in place to initially provide vaccines to those most in need. "The priority for us, as a health protection agency, is to get vaccines to those who need it most," she said.

Independent Body Backs NIH Study

Refuting a whistleblower, who late last year charged the NIH with poor record keeping during an HIV trial in Uganda, the Institute of Medicine, part of the National Academies of Sciences, issued a report supporting the NIH's conduct.

Called HIVNET 012, the perinatal HIV study found Viramune (nevirapine, Boehringer Ingelheim GmbH) to be effective in preventing mother-to-child transmission of HIV.

"The committee finds that the HIVNET 012 investigators met their ethical obligation to design and conduct the study in accordance with international standards for the ethical conduct of research and ethical management of patient care," the Institute of Medicine's report stated.

The report also corroborated previous reviews of the study, calling the data "sound, presented in a balanced manner and [able to be] relied upon for scientific and policy-making purposes."

The NIH said it believes that the findings would "restore confidence in the validity of the conclusions of this study, allow the controversy surrounding this issue to subside, and facilitate policy decisions that seek to promote the health of newborns at risk of HIV infection."