Avian Flu

Controversy over publication H5N1 influenza study


Recently, two unpublished research studies on the transmissibility of influenza A H5N1 viruses have raised urgent questions related to the two studies, as well as broader concerns related to the balance between the need for scientific research and the need to protect public safety.

In a commentary in the journal Nature, flu virologist Yoshihiro Kawaoka argued that he and other high-level influenza scientists are trying to puzzle out why some flu viruses spread in humans while others don’t. He says that, despite claims from US biosecurity experts that the information shouldn’t be published as it may help bioterrorists create effective weapons of disease, this work is too important to be shelved.

In his article, Kawaoka revealed that his laboratory at the University of Wisconsin-Madison made a hybrid virus, fusing the hemagglutinin protein (the H in a flu virus’s name) from H5N1 into the human H1N1 virus that caused the 2009 pandemic.

The H1N1 virus spreads easily among people, but H5N1 currently does not. They found that the viruses came together readily and spread easily among ferrets kept in separate cages. However, the mutant virus did not kill the ferrets, Kawaoka reported.

Kawaoka, who also has an appointment at the University of Tokyo, runs one of two labs caught up in the controversy. The other is run by Dutch virologist Ron Fouchier of Erasmus Medical Centre in Rotterdam. Before now, much more was known about Fouchier’s work because he reported on it at an influenza conference in Malta in fall 2011. Fouchier’s team forced evolution of a Autumn, non-hybrid H5N1 virus in ferrets, getting it to the point where it easily transmitted among the animals and was fatal to some. His paper was due to be published in Science.

Call to block full publication

Before Science and Nature could publish the works, a panel of biosecurity experts urged the US Government to ask the journals not to publish the full studies, saying that to do so would be to print recipes for potential bioterror weapons. The journals and the scientists grudgingly agreed, but the flu community and some others in the science world have objected to the decision, saying to hold back the full details of the studies will impede science that needs to be done.

In the hopes of creating room for a compromise, Kawaoka, Fouchier and 37 other leading flu scientists, announced they would observe a voluntary 60-day moratorium on H5N1 transmission studies.

In his commentary, Kawaoka argued that redacting the studies won’t eliminate the possibility that the information will become public or be used irresponsibly, and that the benefit of his research outweighs these risks. He said: “There is already enough information publicly available to allow someone to make a transmissible H5 HA-possessing virus.” He adds: “Within the past century, ‘Spanish’ influenza, which stemmed from a virus of avian origin, killed between 20 million and 50 million people. Because H5N1 mutations that confer transmissibility in mammals may emerge in nature, I believe that it would be irresponsible not to study the underlying mechanisms.”

Johns Hopkins’ faculty weigh in on the debate – the ethics of H5N1 research

In a commentary on the biosecurity controversy surrounding publication of bird flu research details, a bioethicist and a vaccine expert at Johns Hopkins reaffirm that “all scientists have an affirmative ethical obligation to avoid contributing to the advancement of biowarfare and bioterrorism”, but that there are not sufficient structures in place to evaluate potential societal risks.

The commentary, titled “The Obligation to Prevent the Next Dual-Use Controversy” appears February 9 in the online Policy Forum of the journal Science. Authors Ruth R. Faden, PhD, and Ruth A. Karron, MD, say adequate assessment of those risks requires “prospective review by an international body with a range of expertise, including in this case influenza virology and biosecurity”.

They note that international prospective review of so-called dual-use research will help to mitigate future dilemmas over how to balance global security, academic freedom and public health threats. “There is no doubt that there are formidable obstacles to developing such a global oversight body. But that the challenge is hard is no excuse,” Faden and Karron conclude. Faden is director of the Johns Hopkins Berman Institute of Bioethics, and Karron is director of the Center for Immunization Research and the Johns Hopkins Vaccine Initiative at the Johns Hopkins University Bloomberg School of Public Health.

“When you take the perspective that both science and security experts are trying to prevent a global lethal pandemic, the problem becomes one of benefit-risk assessment and risk management,” says Faden, who draws on her experience as a member of the Fink Committee convened by the National Research Council in 2001 to create a roadmap for evaluating biosecurity risks. The Fink Committee’s recommendations led to the creation of the National Science Advisory Board for Biosecurity (NSABB), which touched off the current controversy over H5N1 research by calling for the redaction of details explaining how a version of the virus that is readily transmissible in ferrets was produced. The NSABB cited concerns that such details could help terrorists make a weapon of the flu virus.

“The challenge is to implement effective practices to properly assess and manage these risks that allow for the vigilant stewardship of both the institution of science and public safety,” Faden and Karron write.

The Hopkins co-authors highlight key ethical dimensions of this challenge, including “a moral obligation to ensure that the results of that research are used to help reduce risks to global health”, the prospect of which must be the ethical justification for undertaking the risk of dual-use research at all.

WHO meeting of experts agrees H5N1 research critical, but extends delay on publication

The World Health Organisation, was asked to help mediate the problem. The WHO set up a meeting of technical experts in Geneva on 16-17 February, involving the scientists who worked on the studies, WHO scientists and a representative from the US biosecurity panel. The meeting aimed to facilitate the discussion of differing opinions that have arisen in recent months after two research groups, one in the Netherlands and the other based in the United States, created versions of the H5N1 influenza virus which are more transmissible in mammals than the H5N1 virus that occurs naturally.

At the meeting, the group of global public health and influenza experts reached consensus on two urgent issues related to the newly created H5N1 influenza viruses: extending the temporary moratorium on research with new laboratory-modified H5N1 viruses and recognition that research on naturallyoccurring H5N1 influenza virus must continue in order to protect public health.

“Given the high death rate associated with this virus – 60% of all humans who have been infected have died – all participants at the meeting emphasized the high level of concern with this flu virus in the scientific community and the need to understand it better with additional research,” says Dr Keiji Fukuda, Assistant Director-General of Health Security and Environment for the World Health Organization. “The results of this new research have made it clear that H5N1 viruses have the potential to transmit more easily between people underscoring the critical importance for continued surveillance and research with this virus.”

The experts at the meeting included lead researchers of the two studies, scientific journals interested in publishing the research, funders of the research, countries who provided the viruses, bioethicists and directors from several WHO collaborating- centre laboratories specializing in influenza.

The group also came to a consensus that delayed publication of the entire manuscripts would have more public health benefit than urgently partially publishing.

“There is a preference from a public health perspective for full disclosure of the information in these two studies. However, there is significant public concern surrounding this research that should first be addressed,” said Fukuda.

Two critical issues are to increase public awareness and understanding of this research through communications and the review of biosafety and biosecurity aspects raised by the new laboratory-modified H5N1 influenza virus. WHO says they will continue discussion with relevant experts to move this forward.

WHO adds that broad issues raised, but not limited to, these research studies will be discussed at future meetings convened by WHO with participation by a broader range of experts and interested parties relevant to these issues.

ate of upload: 24th Mar 2012


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