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U.S. Biosecurity Board Synchs with WHO on H5N1 Flu Papers

Late this afternoon, the U.S. National Science Advisory Board for Biosecurity announcedthat it reversed its initial ruling, and will support open publication of two research articles that describe the creation of mutant strains of H5N1 avian influenza that are capable of air-borne transmission between mammals.

The new NSABB decision, which came at the end of two days of consideration of revised versions of both papers, brought the U.S. panel into agreement with a review panel convened by the World Health Organization in February that also supported full publication of the papers.

H5N1 virus/courtesy CDC; Cynthia Goldsmith, Jackie Katz

When the NSABB first reviewed the original versions of the papers last December, it decided that publication of the methods sections of the article written by Dr. Yoshihiro Kawaoka of the University of Wisconsin in Madison, and a second article written by Dr. Ron Fouchier of Erasmus Medical Center in Rotterdam, posed too much of a public health risk because of the “dual use” risk of their work. The NSABB said it feared that full disclosure of details of how these researchers produced the mutated H5N1 strains that allowed the highly pathogenic virus to spread through the air from mammal-to-mammal (in a ferret model) posed too great a danger that the information could be used in a way that endangered public health.

In its statement today, the NSABB said that “While the communication of the information in these revised manuscripts still presents dual use concerns, the additional information changed the Board’s risk/benefit calculation.”

The NSABB said that it voted unanimously to recommend full publication of Dr. Kawaoka’s revised manuscript, and that it voted 12-6 in favor of full publication of Dr. Fouchier’s revised manuscript.

“The data described in the revised manuscripts do not appear to provide information that would immediately enable misuse of the research in ways that would endanger public health or national security,” the NSABB said.

Although the NSABB statement did not elaborate on the nature of the revisions, Dr. Fouchier said at an open meeting in February that the mutant influenza he had produced was not as easily transmitted nor as pathogenic as initial press reports had suggested. Speaking at that meeting, Dr. Anthony Fauci , director of the National Institute of Allergy and Infectious Diseases, said that this revised information from Dr. Fouchier had led to the WHO’s decision, and prompted him to ask the NSABB to reconsider both manuscripts.

—Mitchel Zoler (on Twitter @mitchelzoler)

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New Details Further Blunt the H5N1 Flu Danger

Dr. Ron Fouchier, one of the two researchers who developed and studied mutant forms of avian H5N1 influenza that’s transmissible through the air, provided new details of his findings at a conference this morning in Washington. He explained that the mutant virus is not nearly as deadly or transmissible as many people have supposed.

This new information seems to be, at least in part, at the root of the different conclusions recently reached by the U.S. National Science Advisory Board for Biosecurity (NSABB) and by a group organized by the World Health Organization (WHO) on whether detailed methods of the H5N1 mutant research should be released to the public. During the past few days, the National Institutes of Health called on the NSABB to meet again to hear the new data and see if it would change the Board’s decision to keep the methods sections of the papers under wraps, Dr. Anthony Fauci said at today’s meeting.

ferret; courtesy hemmer@fr.wikipedia, Wikimedia Commons

“This virus does not kill ferrets that are sneezed on [by ferrets already infected with mutant H5N1], and if it was released it is unlikely that it would spread like wildfire, and to extrapolate that it would spread like wildfire in humans is really farfetched at this stage,” said Dr. Fouchier, a researcher at Erasmus University in Rotterdam. “This virus does not spread like a pandemic or seasonal influenza virus,” he said in a session that dealt with H5N1 issues during a meeting on Biodefense and Emerging Diseases sponsored by the American Society for Microbiology. He called any notion that the mutant avian H5N1 flu he created could transmit readily in aerosolized form from ferret-to-ferret a “misperception.”

In addition, many people have had a second important misperception of the virus he’s studied: The H5N1 mutant strains he created are not highly lethal.

“It’s very clear that H5N1 is highly lethal in chickens, but in mammals that’s not the case.” The mutant form of the virus will kill a ferret if you place a large dose of the virus—a million virions—directly into the animals lower respiratory tract. That kills the animal in about 3 days, he said. But if a more modest and typical inoculum gets introduced intranasally to a ferret, the animal simply gets a flu-like illness but recovers. “We saw no severe disease in any of the seven animals that received virus by aerosol,” he said.

A third, heartening observation he’s made about how mammalian-transmissible H5N1 behaves is that ferrets exposed to seasonal flu before exposure to the H5N1 mutant “are fully protected against severe disease.” His conclusion from this: “It’s unlikely that humans have no cross protection to H5N1, so very few would develop severe disease. Most [people] would be protected by cross-protective immunity.”

According to Dr. Fauci, director of the National Institute of Allergy and Infectious Disease, these clarifications from Dr. Fouchier first came to light earlier this month during a meeting on H5N1 convened by the WHO in Geneva. These new data, as well as the recommendations made by the WHO group, led Dr. Fauci to ask the NSABB to reconvene.

“The NIH continues to support the NSABB recommendations regarding the original manuscripts [to publish redacted versions of the papers], and supports revision of the manuscripts to include new data and explicit clarifications of old data,” Dr. Fauci said. “There was obviously a disagreement in the recommendations between Geneva and the NSABB. There was a strong feeling to reconvene the NSABB to give them the benefit of the same information and discussion as in Geneva.”

–Mitchel Zoler (on Twitter @mitchelzoler)

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WHO Trumps U.S. Plan for H5N1 Flu

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

■ Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.

■ Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.

■ Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

WHO headquarters, Geneva/courtesy WHO ©WHO P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Dealing With H5N1 Influenza “Dual Use Research”

 The U.S. National Science Advisory Board for Biosecurity weighed in publicly for the first time yesterday about research on mammalian-adapted H5N1 influenza, and the Board’s verdict was that the research is important and needs to go forward, but must be done very carefully, with oversight, and without releasing potentially dangerous details to the general public.

 Perhaps most importantly, aside from the NSABB giving a general thumbs up to current and future H5N1 research, the Board cried out a clear warning for the world to prepare for a naturally generated H5N1 threat. As acting NSABB chairman Paul S. Keim said in a Q&A that accompanied the Board’s statement in Nature, “It is important to convey how unprepared, on every level, the world is for a H5N1 pandemic.” A highly pathogenic form of H5N1 flu, which the recent work by Kawaoka and Fouchier made clear is a potential natural development, would produce an “unimaginable catastrophe” worldwide, the NSABB said in its statement yesterday.

dual use research/courtesy Library of Congress

The Board also coined a new phrase to categorize the H5N1 work: “dual use research.” Dual in that the research “could be used for good or bad purposes.” That, of course, is why the Board wants the methods part of the work kept off the public record. “Publishing these experiments in detail would provide information to some person, organization, or government that would help them to develop similar mammal-adapted influenza A/H5N1 viruses for harmful purposes,” the NSABB said. The Board said the threat from this work is so high that the life sciences have now “reached a crossroads,” similar to what physics faced in the 1940s with the development of nuclear weapons.

 But despite the threat from widespread release of the research methods—a risk that the NSABB says it believes can be blunted by simply not publishing the information—the Board firmly endorsed the work done so far and its continuation. That contrasts with the continued call from some critics to shut it down completely.

 H5N1 research is “a well-intended effort to discover evolutionary routes by which influenza A/H5N1 viruses might adapt to humans. Such knowledge may be valuable for improving the public-health response to a looming natural threat,” the NSABB said. “We acknowledge that there are clear benefits to be realized for the public good in alerting humanity of this potential threat and in pursuing those aspects of this work that will allow greater preparedness and the potential development of novel strategies leading to future disease control.”

 —Mitchel Zoler (on Twitter @mitchelzoler)

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